tag:theconversation.com,2011:/africa/topics/big-pharma-1150/articlesBig Pharma – The Conversation2024-03-06T17:58:43Ztag:theconversation.com,2011:article/2250662024-03-06T17:58:43Z2024-03-06T17:58:43ZCanadians need to know how much money Big Pharma gives health-care providers, but this information is far too difficult to find<figure><img src="https://images.theconversation.com/files/579973/original/file-20240305-18-ban0k5.jpg?ixlib=rb-1.1.0&rect=310%2C120%2C5216%2C3449&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Patients need to know that treatments are recommended based on patient need, not pharma company interests. That's why it's important to know how much Big Pharma is paying to health-care providers and organizations.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>Drug companies often give payments to physicians, other health-care workers and health-care organizations for things like consulting fees, sitting on advisory boards, speaking at sponsored events or funding research, as well as meals and travel expenses. However, in Canada, it’s difficult to know how much was paid to whom.</p>
<p>Prominent on the website of <a href="https://innovativemedicines.ca/about/ethics/">Innovative Medicines Canada</a> (IMC) — the organization that represents the research-based drug companies operating in Canada — is the statement:</p>
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<p>“As part of our commitment to high ethical standards and enhancing trust, Innovative Medicines Canada has developed a Voluntary Framework on Disclosure of Payments made to health-care professionals and organizations.” </p>
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<p>Based on that commitment, starting in 2016, <a href="https://doi.org/10.12927%2Fhcpol.2022.26729">10 companies</a> — fewer than one-quarter of IMC’s members — have been reporting how much in total they gave to doctors and organizations.</p>
<p>In order to maintain faith in the integrity of treatments that doctors and other health-care providers and organizations offer their patients, it’s vital that the public knows that the choice of therapy is based on the patient’s best interest and not on the interest of the company that makes the drug.</p>
<h2>Lack of transparency</h2>
<p>When the disclosures began, the president of IMC said the <a href="https://www.theglobeandmail.com/news/national/canadian-drug-makers-assailed-for-lack-of-transparency-over-payments/article35392284/">revelations were only the first step in increased transparency</a>, and that more companies were expected to disclose payments in the coming years. However, since that time, there has not been an increase in the amount of information disclosed nor in the number of companies participating.</p>
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<img alt="A person in a business suit shaking hands with someone in a white coat who is holding a box" src="https://images.theconversation.com/files/579970/original/file-20240305-20-ioc67p.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/579970/original/file-20240305-20-ioc67p.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/579970/original/file-20240305-20-ioc67p.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/579970/original/file-20240305-20-ioc67p.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/579970/original/file-20240305-20-ioc67p.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/579970/original/file-20240305-20-ioc67p.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/579970/original/file-20240305-20-ioc67p.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Canada’s disclosure guidelines don’t require pharma companies to disclose which doctors and organizations have received payments, or what they have done to earn the money.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
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<p>In fact, two companies have stopped disclosing information altogether so now only eight companies out of the 48 that belong to IMC make even these minimum disclosures. Another company has not disclosed payments since 2021. The IMC website still lists 10 participating companies. </p>
<p>The disclosures are not centrally collected by IMC; anyone interested has to hunt around on the individual companies’ websites to find the reports. Of course, there are no penalties for failing to disclose because it’s voluntary.</p>
<p>What do we know from the information that has been disclosed? Over seven years (2016-2022) the 10 disclosing companies gave over $236 million to doctors and almost $213 million to organizations. </p>
<p>Which doctors and organizations have received these payments, what have they done to earn the money? We don’t know, because the disclosures don’t name names or give the specific purpose of the payments. And since names are withheld, the amounts given to individual doctors or organizations are also not available.</p>
<h2>Transparency in other countries</h2>
<p>In asking for the disclosure of so little information, IMC is unique among pharmaceutical industry associations in high-income countries. Disclosure systems in Australia, most European countries, <a href="https://doi.org/10.1186/s12992-022-00902-9">Japan</a>, <a href="https://www.medicinesnz.co.nz/our-industry/transparency-guidelines">New Zealand</a> and the United Kingdom are run by their respective industry associations. In some cases, they are still voluntary and there are also weaknesses in what they reveal — for example individual doctors can opt out of being named.</p>
<p>But they all also require that companies provide far more information than IMC does. The <a href="https://www.efpia.eu/media/413643/efpia_about_disclosure_code_updated-july-2019.pdf">European Federation of Pharmaceutical Industries and Associations</a> requires all member companies to disclose the names of professionals and organizations that have received payments or other transfers of value from them. They have to disclose the total amounts of value transferred by type of activity such as grants, consultancy fees, travel payments and registration fees to attend a medical education congress.</p>
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<img alt="A person in a white coat out of focus in the background with a prescription bottle in the foreground" src="https://images.theconversation.com/files/579972/original/file-20240305-30-aon8rd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/579972/original/file-20240305-30-aon8rd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/579972/original/file-20240305-30-aon8rd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/579972/original/file-20240305-30-aon8rd.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/579972/original/file-20240305-30-aon8rd.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/579972/original/file-20240305-30-aon8rd.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/579972/original/file-20240305-30-aon8rd.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Research has shown that even a $20 meal is enough to influence prescribing behaviour.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
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<p>These disclosures can tell us a lot about how companies and health-care professionals interact. In the <a href="https://doi.org/10.1136/bmjopen-2017-016701">four years up to September 2015</a>, 42 Australia-based companies sponsored 116,845 events for health professionals, on average 608 per week with 30 attendees per event. The median cost per event was $263 and over 90 per cent included food and beverages.</p>
<p><a href="https://haiweb.org/wp-content/uploads/2017/03/Sunshine-Act.pdf">France, Denmark, Greece, Romania, Latvia, Italy</a>, <a href="https://www.policymed.com/2017/08/sunshine-act-takes-effect-in-south-korea.html">South Korea</a> and especially the United States with its <a href="https://doi.org/10.1056/NEJMp1305090">Physician Payments Sunshine Act</a> go even further and have legislation making reporting a legal requirement. </p>
<p>The U.S. Sunshine Act mandates that pharmaceutical and medical device companies report gifts or any other transfer of value of US$10 or greater to physicians and teaching hospitals. The types of payments that need to be reported include consulting fees, honoraria, gifts, entertainment, food and beverages, travel and lodging, education, research, charitable contributions, royalties or licenses, ownership or investment interests, speakers’ fees and grants. </p>
<p>All of this information is publicly available in the <a href="https://doi.org/10.1007/s11606-021-06657-0">Open Payments database</a> maintained by the Centers for Medicare and Medicaid Services.</p>
<p>A key feature of the Open Payments database is the requirement for companies to name the product(s) that their payments are tied to. This feature has allowed researchers to examine links between doctors’ payments and prescribing. As a result, we know that a $20 meal — not much more than the price of a Quarter Pounder, fries and a Coke at McDonalds — is <a href="https://doi.org/10.1001/jamainternmed.2016.2765">enough to increase prescribing</a> of the drug(s) made by the company providing the meal.</p>
<p>Ontario was poised to go even further than the Sunshine Act. Before the 2019 election, the government was finalizing regulations for <a href="https://www.ontario.ca/laws/statute/s17025">Bill 160</a>, which would have required that all drug and device manufacturers that provided a “transfer of value” to individual health-care practitioners and health-care organizations, including patient groups, report those transfers to a public registry. The <a href="https://doi.org/10.1503/cmaj.109-5718">election of a Progressive Conservative government</a> killed that initiative.</p>
<p>Canadians deserve more transparency about pharma companies’ payments to health-care providers. Multiple studies, including <a href="https://doi.org/10.1371/journal.pmed.1000352">one that I participated in</a>, have looked at what happens when doctors take payments from drug companies. Their prescribing almost never improves. It either stays the same or, more worrisome, it gets worse. Canadians need to know what Big Pharma is paying to whom, since these payments may not be to the benefit of patients.</p><img src="https://counter.theconversation.com/content/225066/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Between 2020-2024, Joel Lexchin received payments for writing a brief on the role of promotion in generating prescriptions for a legal firm, for being on a panel about pharmacare and for co-writing an article for a peer-reviewed medical journal. He is a member of the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. He is participating in research funded by the Canadian Institutes of Health Research.</span></em></p>Canada has a lack of transparency about Big Pharma’s payments to health-care providers and organizations. Disclosure is voluntary, and there’s no central data on even the few companies that do report.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, CanadaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2225072024-02-18T19:51:33Z2024-02-18T19:51:33ZOut of the rabbit hole: new research shows people can change their minds about conspiracy theories<p>Many people <a href="https://theconversation.com/was-phar-lap-killed-by-gangsters-new-research-shows-which-conspiracies-people-believe-in-and-why-158610">believe at least one</a> conspiracy theory. And that isn’t necessarily a bad thing – conspiracies <em>do</em> happen.</p>
<p>To take just one example, the CIA really did engage in <a href="https://www.politico.com/story/2019/04/13/cia-mind-control-1266649">illegal experiments</a> in the 1950s to identify drugs and procedures that might produce confessions from captured spies.</p>
<p>However, many conspiracy theories are not supported by evidence, yet still attract believers. </p>
<p>For example, in a <a href="https://doi.org/10.1111/pops.12746">previous study</a>, we found about 7% of New Zealanders and Australians agreed with the theory that <a href="https://www.earthdata.nasa.gov/learn/sensing-our-planet/on-the-trail-of-contrails">visible trails behind aircraft</a> are “chemtrails” of chemical agents sprayed as part of a secret government program. That’s despite the theory being <a href="https://iopscience.iop.org/article/10.1088/1748-9326/11/8/084011">roundly rejected</a> by the scientific community. </p>
<p>The fact that conspiracy theories attract believers despite a lack of credible evidence remains a puzzle for researchers in psychology and other academic disciplines. </p>
<p>Indeed, there has been a great deal of research on conspiracy theories published in the past few years. We now know more about how many people believe them, as well as the psychological and political factors that <a href="https://www.nature.com/articles/s41598-022-25617-0">correlate with that belief</a>.</p>
<p>But we know much less about how often people change their minds. Do they do so frequently, or do they to stick tenaciously to their beliefs, regardless of what evidence they come across?</p>
<h2>From 9/11 to COVID</h2>
<p>We set out to answer this question using a <a href="https://doi.org/10.1038/s41598-024-51653-z">longitudinal survey</a>. We recruited 498 Australians and New Zealanders (using the <a href="http://prolific.com">Prolific</a> website, which recruits people to take part in paid research). </p>
<p>Each month from March to September 2021, we presented our sample group with a survey, including ten conspiracy theories, and asked them how much they agreed with each one. </p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/taylor-swift-nfl-conspiracy-theories-are-the-result-of-two-sets-of-hardcore-fans-colliding-223020">Taylor Swift-NFL conspiracy theories are the result of two sets of hardcore fans colliding</a>
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<p>All of these theories related to claims about events that are either ongoing, or occurred this millennium: the September 11 attacks, the rollout of 5G telecommunications technology, and COVID-19, among others.</p>
<p>While there were definitely some believers in our sample, most participants disagreed with each of the theories. </p>
<p>The most popular theory was that “pharmaceutical companies (‘Big Pharma’) have suppressed a cure for cancer to protect their profits”. Some 18% of the sample group agreed when first asked.</p>
<p>The least popular was the theory that “COVID-19 ‘vaccines’ contain microchips to monitor and control people”. Only 2% agreed.</p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/intelligence-doesnt-make-you-immune-to-conspiracy-theories-its-more-about-thinking-style-220978">Intelligence doesn't make you immune to conspiracy theories – it's more about thinking style</a>
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<h2>Conspiracy beliefs probably aren’t increasing</h2>
<p>Despite contemporary concerns about a “<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7320252/">pandemic of misinformation</a>” or “<a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30461-X/fulltext">infodemic</a>”, we found no evidence that individual beliefs in conspiracy theories increased on average over time. </p>
<p>This was despite our data collection happening during the tumultuous second year of the COVID-19 pandemic. Lockdowns were still happening occasionally in both <a href="https://www.timeout.com/melbourne/things-to-do/a-timeline-of-covid-19-in-australia-two-years-on">Australia</a> and <a href="https://covid19.govt.nz/about-our-covid-19-response/history-of-the-covid-19-alert-system/">New Zealand</a>, and anti-government sentiment was building. </p>
<p>While we only tracked participants for six months, <a href="https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0270429">other studies</a> over much longer time frames have also found little evidence that beliefs in conspiracy theories are increasing over time.</p>
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<p>Finally, we found that beliefs (or non-beliefs) in conspiracy theories were stable – but not completely fixed. For any given theory, the vast majority of participants were “consistent sceptics” – not agreeing with the theory at any point. </p>
<p>There were also some “consistent believers” who agreed at every point in the survey they responded to. For most theories, this was the second-largest group. </p>
<p>Yet for every conspiracy theory, there was also a small proportion of converts. They disagreed with the theory at the start of the study, but agreed with it by the end. There was also a small proportion of “apostates” who agreed with the theory at the start, but disagreed by the end.</p>
<p>Nevertheless, the percentages of converts and apostates tended to balance each other pretty closely, leaving the percentage of believers fairly stable over time. </p>
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<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/conspiracy-theories-arent-on-the-rise-we-need-to-stop-panicking-208033">Conspiracy theories aren't on the rise – we need to stop panicking</a>
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<h2>Inside the ‘rabbit hole’</h2>
<p>This relative stability is interesting, because <a href="https://www.jstor.org/stable/2564659">one criticism</a> of conspiracy theories is that they may not be “<a href="https://www.britannica.com/topic/criterion-of-falsifiability">falsifiable</a>”: what seems like evidence against a conspiracy theory can just be written off by believers as part of the cover up. </p>
<p>Yet people clearly <em>do</em> sometimes decide to reject conspiracy theories they previously believed. </p>
<p>Our findings bring into question the popular notion of the “rabbit hole” – that people rapidly develop beliefs in a succession of conspiracy theories, much as Alice tumbles down into Wonderland in Lewis Carroll’s <a href="https://www.gutenberg.org/ebooks/11">famous story</a>.</p>
<p>While it’s possible this does happen for a small number of people, our results suggest it isn’t a typical experience. </p>
<p>For most, the <a href="https://www.latrobe.edu.au/news/articles/2023/opinion/how-to-talk-to-someone-about-conspiracy-theories">journey into</a> conspiracy theory belief might involve a more gradual slope – a bit like a <a href="https://zslpublications.onlinelibrary.wiley.com/doi/pdfdirect/10.1111/j.1469-7998.1985.tb05649.x">real rabbit burrow</a>, from which one can also emerge.</p>
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<p><em>Mathew Ling (<a href="https://www.neaminational.org.au/">Neami National</a>), Stephen Hill (Massey University) and Edward Clarke (Philipps-Universität Marburg) contributed to the research referred to in this article.</em></p>
<hr><img src="https://counter.theconversation.com/content/222507/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Data collection for this study was supported by the Massey University Strategic Research Excellence Fund. Matt Williams also receives funding from the Marsden Fund Council, managed by the Royal Society Te Apārangi.</span></em></p><p class="fine-print"><em><span>John Kerr works for the Public Health Communication Centre, which is funded by a philanthropic endowment from the Gama Foundation. </span></em></p><p class="fine-print"><em><span>Mathew Marques does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>A new study has found no evidence that people’s beliefs in conspiracy theories increase over time. They can even change their minds – just not that often.Matt Williams, Senior Lecturer in Psychology, Massey UniversityJohn Kerr, Senior Research Fellow, University of OtagoMathew Marques, Senior Lecturer in Social Psychology, La Trobe UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2195722023-12-14T13:10:22Z2023-12-14T13:10:22ZCRISPR and other new technologies open doors for drug development, but which diseases get prioritized? It comes down to money and science<figure><img src="https://images.theconversation.com/files/565611/original/file-20231213-19-56i402.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2070%2C1449&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">So many diseases to treat, so little money and time.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/covid-19-vaccine-loop-royalty-free-image/1288570747">Andriy Onufriyenko/Moment via Getty Images</a></span></figcaption></figure><p>Prescription drugs and vaccines revolutionized health care, dramatically decreasing death from disease and improving quality of life across the globe. But how do researchers, universities and hospitals, and the pharmaceutical industry decide which diseases to pursue developing drugs for?</p>
<p>In <a href="https://scholar.google.com/citations?user=lWAD9d8AAAAJ&hl=en">my work</a> as director of the <a href="https://pharmacy.uconn.edu/hopes/">Health Outcomes, Policy, and Evidence Synthesis</a> group at the University of Connecticut School of Pharmacy, I assess the effectiveness and safety of different treatment options to help clinicians and patients make informed decisions. My colleagues and I study ways to create new drug molecules, deliver them into the body and improve their effectiveness while reducing their potential harms. Several factors determine which avenues of drug discovery that people in research and pharmaceutical companies focus on.</p>
<h2>Funding drives research decisions</h2>
<p>Research funding amplifies the pace of scientific discovery needed to create new treatments. Historically, <a href="https://doi.org/10.1001/jamahealthforum.2023.1921">major supporters of research</a> like the National Institutes of Health, pharmaceutical industry and private foundations funded studies on the most common conditions, like heart disease, diabetes and mental health disorders. A <a href="https://doi.org/10.18553%2Fjmcp.2022.28.7.732">breakthrough therapy</a> would help millions of people, and a small markup per dose would generate hefty profits.</p>
<p>As a consequence, research on rare diseases was not well-funded for decades because it would help fewer people and the costs of each dose had to be very high to turn a profit. Of the <a href="https://www.fda.gov/patients/rare-diseases-fda">more than 7,000 known rare diseases</a>, defined as <a href="https://rarediseases.info.nih.gov/about">fewer than 200,000 people affected</a> in the U.S., <a href="https://www.ncbi.nlm.nih.gov/books/NBK56187/">only 34 had a therapy approved</a> by the Food and Drug Administration before 1983.</p>
<p>The passage of the <a href="https://doi.org/10.1371%2Fjournal.pmed.1002191">Orphan Drug Act</a> changed this trend by offering tax credits, research incentives and prolonged patent lives for companies actively developing drugs for rare diseases. From 1983 to 2019, <a href="https://doi.org/10.1186/s13023-021-01901-6">724 drugs</a> were approved for rare diseases.</p>
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<a href="https://images.theconversation.com/files/565616/original/file-20231213-27-em9ehu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Person sluicing a bucket of ice water over another person's head" src="https://images.theconversation.com/files/565616/original/file-20231213-27-em9ehu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/565616/original/file-20231213-27-em9ehu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/565616/original/file-20231213-27-em9ehu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/565616/original/file-20231213-27-em9ehu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/565616/original/file-20231213-27-em9ehu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/565616/original/file-20231213-27-em9ehu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/565616/original/file-20231213-27-em9ehu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">The viral ALS ice bucket challenge in 2014 was a fundraising success.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/IceBucketChallenge/4dd78b9ab4044aef8a09a6f7d688b168">Elise Amendola/AP Photo</a></span>
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<p>Emerging social issues or opportunities can significantly affect funding available to develop drugs for certain diseases. When COVID-19 raged across the world, funding from <a href="https://www.nationaldefensemagazine.org/articles/2023/9/19/learning-lessons-from-mrap-operation-warp-speed">Operation Warp Speed</a> led to vaccine development in record time. Public awareness campaigns such as the <a href="https://www.npr.org/2022/10/01/1126397565/the-ice-bucket-challenge-wasnt-just-for-social-media-it-helped-fund-a-new-als-dr">ALS ice bucket challenge</a> can also directly raise money for research. This viral social media campaign provided 237 scientists <a href="https://www.als.org/stories-news/ice-bucket-challenge-dramatically-accelerated-fight-against-als#">nearly US$90 million</a> in research funding from 2014 to 2018, which led to the discovery of five genes connected to amyotrophic lateral sclerosis, commonly called Lou Gehrig’s disease, and new clinical trials.</p>
<h2>How science approaches drug development</h2>
<p>To create breakthrough treatments, researchers need a basic understanding of what disease processes they need to enhance or block. This requires developing <a href="https://doi.org/10.1002/jcph.1569">cell and</a> <a href="https://theconversation.com/expanding-alzheimers-research-with-primates-could-overcome-the-problem-with-treatments-that-show-promise-in-mice-but-dont-help-humans-188207">animal models</a> that can simulate human biology. </p>
<p>It can <a href="https://www.fda.gov/drugs/development-approval-process-drugs">take many years</a> to vet potential treatments and develop the finished drug product ready for testing in people. Once scientists identify a potential biological target for a drug, they use <a href="https://theconversation.com/discovering-new-drugs-is-a-long-and-expensive-process-chemical-compounds-that-dupe-screening-tools-make-it-even-harder-175972">high-throughput screening</a> to rapidly assess hundreds of chemical compounds that may have a desired effect on the target. They then modify the most promising compounds to enhance their effects or reduce their toxicity. </p>
<p>When these compounds have lackluster results in the lab, companies are likely to <a href="https://doi.org/10.1186%2Fs12967-016-0838-4">halt development</a> if the estimated potential revenue from the drug is less than the estimated cost to improve the treatments. Companies can charge more money for drugs that <a href="https://digital.kwglobal.com/publication/?i=456831&p=13&view=issueViewer&pp=1">dramatically reduce deaths or disability</a> than for those that only reduce symptoms. And researchers are more likely to continue working on drugs that have a greater potential to help patients. In order to obtain FDA approval, companies ultimately need to show that the drug causes more benefits for patients than harms. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/2sAGtqm3o1g?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Casgevy, a CRISPR-based treatment for sickle cell anemia, is considered a milestone in gene therapy.</span></figcaption>
</figure>
<p>Sometimes, researchers know a lot about a disease, but available technology is insufficient to produce a successful drug. For a long time, scientists knew that <a href="https://doi.org/10.1056/NEJMoa2031054">sickle cell disease</a> results from a defective gene that leads cells in the bone marrow to produce poorly formed red blood cells, causing severe pain and blood clots. Scientists lacked a way to fix the issue or to work around it with existing methods. </p>
<p>However, in the early 1990s, basic scientists discovered that bacterial cells have a mechanism to <a href="https://theconversation.com/human-genome-editing-offers-tantalizing-possibilities-but-without-clear-guidelines-many-ethical-questions-still-remain-200983">identify and edit DNA</a>. With that model, researchers began painstaking work developing a <a href="https://www.broadinstitute.org/what-broad/areas-focus/project-spotlight/crispr-timeline">technology called CRISPR</a> to identify and edit genetic sequences in human DNA. </p>
<p>The technology finally progressed to the point where scientists were able to successfully target the problematic gene in patients with sickle cell and edit it to produce normally functioning red blood cells. In December 2023, <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapies-treat-patients-sickle-cell-disease">Casgevy became the first CRISPR-based drug</a> approved by the FDA.</p>
<p>Sickle cell disease made a great target for this technology because it was caused by a single genetic issue. It was also an attractive disease to focus on because it affects around 100,000 people in the U.S. and is <a href="https://doi.org/10.2147/ijgm.s257340">costly to society</a>, causing many hospitalizations and lost days of work. It also <a href="https://theconversation.com/sickle-cell-disease-can-be-deadly-and-the-persistent-health-inequities-facing-black-americans-worsen-the-problem-212434">disproportionately affects Black Americans</a>, a population that has been <a href="https://theconversation.com/yes-black-patients-do-want-to-help-with-medical-research-here-are-ways-to-overcome-the-barriers-that-keep-clinical-trials-from-recruiting-diverse-populations-185337">underrepresented in medical research</a>.</p>
<h2>Real-world drug development</h2>
<p>To put all these pieces of drug development into perspective, consider the <a href="https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm">leading cause of death in the U.S.</a>: cardiovascular disease. Even though there are several drug options available for this condition, there is an ongoing need for more effective and less toxic drugs that reduce the risk of heart attacks and strokes. </p>
<p>In 1989, epidemiologists found that patients with <a href="https://doi.org/10.1001/jama.300.11.1343">higher levels of bad, or LDL, cholesterol</a> had more heart attacks and strokes than those with lower levels. Currently, <a href="https://www.cdc.gov/cholesterol/facts.htm#">86 million American adults</a> have elevated cholesterol levels that can be treated with drugs, like the popular statins Lipitor (atorvastatin) or Crestor (rosuvastatin). However, <a href="https://www.pharmacypracticenews.com/Clinical/Article/06-22/Using-National-Guidelines-to-Determine-Hyperlipidemia-Treatment/67209">statins alone</a> cannot get everyone to their cholesterol goals, and many patients develop unwanted symptoms limiting the dose they can receive.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/565617/original/file-20231213-14492-77b8o9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Two blister packs of burnt orange pills with days of the week listed on each dose" src="https://images.theconversation.com/files/565617/original/file-20231213-14492-77b8o9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/565617/original/file-20231213-14492-77b8o9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=386&fit=crop&dpr=1 600w, https://images.theconversation.com/files/565617/original/file-20231213-14492-77b8o9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=386&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/565617/original/file-20231213-14492-77b8o9.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=386&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/565617/original/file-20231213-14492-77b8o9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=485&fit=crop&dpr=1 754w, https://images.theconversation.com/files/565617/original/file-20231213-14492-77b8o9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=485&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/565617/original/file-20231213-14492-77b8o9.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=485&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">There are several statins on the market to treat high cholesterol levels.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/daily-statin-dose-royalty-free-image/643755285">Peter Dazeley/The Image Bank via Getty Images</a></span>
</figcaption>
</figure>
<p>So scientists developed models to understand how LDL cholesterol is created in and removed from the body. They found that LDL receptors in the liver removed bad cholesterol from the blood, but a <a href="https://doi.org/10.1177/1074248418769040">protein called PCSK9</a> prematurely destroys them, boosting bad cholesterol levels in the blood. This led to the development of the drugs <a href="https://doi.org/10.1177/1074248418769040">Repathy (evolocumab) and Praluent (alirocumab)</a> that bind to PCSK9 and stop it from working. Another drug, <a href="https://doi.org/10.1002/jcph.2045">Leqvio (inclisiran)</a>, blocks the genetic material coding for PCSK9. </p>
<p>Researchers are also developing a <a href="https://www.pharmacypracticenews.com/Online-First/Article/12-23/Novel-Gene-Therapy-Slashes-LDL-in-Patients-With-Hypercholesterolemia/72152">CRISPR-based method</a> to more effectively treat the disease.</p>
<h2>The future of drug development</h2>
<p>Drug development is driven by the priorities of their funders, be it governments, foundations or the pharmaceutical industry. </p>
<p>Based on the market, companies and researchers tend to study highly prevalent diseases with devastating societal consequences, such as <a href="https://pubmed.ncbi.nlm.nih.gov/33756057/">Alzheimer’s disease</a> and <a href="https://www.cdc.gov/opioids/data/index.html">opioid use disorder</a>. But the work of advocacy groups and foundations can enhance research funding for other specific diseases and conditions. Policies like the Orphan Drug Act also create successful incentives to discover treatments for rare diseases. </p>
<p>However, in 2021, 51% of drug discovery spending in the U.S. was directed at <a href="https://www.evernorth.com/articles/specialty-drug-trends-and-utilization">only 2% of the population.</a>. How to strike a balance between providing incentives to develop <a href="https://theconversation.com/the-price-of-a-miracle-should-we-limit-spending-on-lifesaving-drugs-79609">miracle drug therapies</a> for a few people at the expense of the many is a question researchers and policymakers are still grappling with.</p><img src="https://counter.theconversation.com/content/219572/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>C. Michael White does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Drug development takes a great deal of time, money and effort. While future profits play a big factor in which diseases gets prioritized, advocacy and research incentives can also tilt the scale.C. Michael White, Distinguished Professor of Pharmacy Practice, University of ConnecticutLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2130412023-09-11T23:27:09Z2023-09-11T23:27:09ZWith a pharmacare bill on the horizon, Big Pharma’s attack on single-payer drug coverage for Canadians needs a fact check<figure><img src="https://images.theconversation.com/files/547294/original/file-20230908-23-s1i9fc.jpg?ixlib=rb-1.1.0&rect=201%2C23%2C4974%2C3243&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Under a pharmacare plan, a single bargaining agent negotiates for lower prices from drug companies.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><iframe style="width: 100%; height: 100px; border: none; position: relative; z-index: 1;" allowtransparency="" allow="clipboard-read; clipboard-write" src="https://narrations.ad-auris.com/widget/the-conversation-canada/with-a-pharmacare-bill-on-the-horizon-big-pharmas-attack-on-single-payer-drug-coverage-for-canadians-needs-a-fact-check" width="100%" height="400"></iframe>
<p>Health Minister Mark Holland <a href="https://www.cbc.ca/news/politics/mark-holland-health-minister-pharmacare-1.6938470">announced in August</a> that the federal government intends to introduce pharmacare legislation in the fall. Now the battle lines are being drawn.</p>
<p>One of the many virtues of pharmacare — a universal drug coverage plan — is that there will be a single bargaining agent looking for lower prices from the drug companies. Australia has a single buyer and has brand-name prices that are on average <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2021.html">29 per cent lower than Canada’s</a>. That difference on Canadian annual sales of $17.4 billion translates into savings of about $5 billion.</p>
<p>Pharmaceutical and insurance industries that stand to lose profit through lower drug prices are not happy about pharmacare. They are speaking out and mobilizing their allies. </p>
<h2>‘Fill in the gaps’</h2>
<p>Innovative Medicines Canada, the lobby group for Big Pharma, is pushing for a “<a href="https://innovativemedicines.ca/newsroom/all-news/imc-calls-on-canadas-premiers-to-improve-patient-access-to-medicines/">fill in the gaps</a>” model. That means providing coverage for people who don’t have drug insurance, but leaving the current system otherwise untouched.</p>
<p>Québec already has “filled in the gaps.” However, it <a href="https://doi.org/10.1503/cmaj.170726">hasn’t achieved the solutions shown in countries with pharmacare</a>. Québec spends more per capita on drugs than other provinces. A greater percentage of people in Québec (8.7 per cent) report spending more than $1,000 on prescription drugs in one year, compared to comparable countries with pharmacare (three per cent) or even the rest of Canada (4.8 per cent).</p>
<p>In Québec, nine per cent of its residents report that they go without their medications because they cannot afford them. While this is an improvement on the rest of the country, with 11 per cent of Canadians in other provinces skipping medications due to costs, it is still significantly higher than the numbers in most comparable countries with pharmacare (six per cent or less).</p>
<h2>The 97 per cent myth</h2>
<p>GreenShield, a not-for-profit health benefits provider and a member of the Canadian Life and Health Insurance Association (CLHIA), appears to share the insurance industry’s stand against pharmacare. In July it <a href="https://www.theglobeandmail.com/business/article-greenshield-cares-essential-medicines-low-income/">announced a pilot program</a> that will offer up to $1,000 in drug coverage to low-income Canadians who do not have public or private prescription drug insurance.</p>
<p>In making the announcement, GreenShield’s chief executive Zahid Salman repeated the myth that 97 per cent of Canadians already have drug coverage. That 97 per cent number is theoretical. Having some form of coverage does not necessarily make drugs affordable. For example, if you live in <a href="https://www.gov.mb.ca/health/pharmacare/estimator.html">Manitoba</a> and your family income is $47,500, you’ll first have to pay $2,760 out of pocket. Anything less and there’s no public coverage. </p>
<p>According to a recent report from <a href="https://www150.statcan.gc.ca/n1/pub/75-006-x/2022001/article/00011-eng.htm">Statistics Canada</a>, 33 per cent of seniors in Manitoba don’t have drug coverage. (That figure might be lower if some seniors who are eligible for provincial insurance didn’t register or were unaware that they were covered.)</p>
<h2>Not everyone has workplace benefits</h2>
<p>CLHIA came out swinging after the federal NDP tabled a <a href="https://www.ctvnews.ca/politics/ndp-attempts-to-prod-liberals-into-action-on-pharmacare-by-tabling-its-own-bill-1.6439036">pharmacare bill</a> in June. The NDP’s bill called for a federal, universal, public and single-payer drug plan. In other words, a plan similar to what Canadians already enjoy for doctor and hospital services. </p>
<p>Denis Ricard, chair of the CLHIA’s board of directors, has claimed that “<a href="https://breachmedia.ca/greenshield-insurance-industry-fights-liberal-ndp-pharmacare/">a fully one-payer national pharmacare is going to be a disaster for this country</a>.”</p>
<p>The <a href="https://betterhealthbenefits.ca/">Better Health Benefits, Together</a> campaign being run by the CLHIA warns that Canadians “can’t afford to lose their workplace benefits because of politics…Done the wrong way, Canadians will lose access to medicines they use today.” </p>
<p>The campaign fails to mention that workplace benefits do not cover everyone, and exclude those experiencing unemployment, which affects some populations more than others. For example, <a href="https://www150.statcan.gc.ca/n1/pub/75-006-x/2022001/article/00011-eng.htm">racialized Canadians have a higher unemployment rate</a> than the rest of the population and therefore are less likely to have work-based drug coverage. </p>
<p>Nor does the campaign mention that, according to <a href="https://www150.statcan.gc.ca/n1/pub/75-006-x/2022001/article/00011-eng.htm">Statistics Canada</a>, “the majority of insurance coverage changes due to the pandemic were negative,” with immigrants faring worse than non-immigrants.</p>
<h2>High deductibles</h2>
<p>Joining the battle against pharmacare is <a href="https://www.thestar.com/opinion/contributors/canada-has-in-fact-achieved-universal-drug-insurancecoverage/%2520article_65bc7a1e-8fb2-56d5-abb8-1b5890909597.html">Brett Skinner</a>, the CEO of the free market Canadian Health Policy Institute. Skinner’s message is that a national government-run drug insurance program is not necessary and will be bad for patients and costly for taxpayers. </p>
<p>He argues that private plans cover more drugs, and cover new drugs more quickly than public plans, and that if Canadians are faced with high deductibles there are provincial programs to deal with them.</p>
<p>He neglects to mention that <a href="https://doi.org/10.1177%2F20542704231166620">only about 10 to 15 per cent of new drugs provide any substantial new benefits</a> compared to existing drugs. He fails to note that a third of the difference in the time between public and private coverage is because <a href="https://doi.org/10.9778/cmajo.20220063">drug companies don’t take advantage of the opportunity to apply for coverage as quickly as they could</a>. </p>
<p>Skinner also ignores the fact that <a href="https://doi.org/10.1503%2Fjpn.180051">people living in Manitoba</a> with an annual income of just over $55,000 who are taking three drugs a day are faced with deductibles of up to $350 every three months. British Columbia residents aren’t far behind at $300 every three months.</p>
<p>Big Pharma, the insurance industry and free market zealots are all motivated by money and ideology. In a battle over people’s health, greed shouldn’t be the winner.</p><img src="https://counter.theconversation.com/content/213041/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Between 2019-2023, Joel Lexchin received payments for writing briefs on the role of promotion in generating prescriptions for two legal firms. He is a member of the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. Between 2017 and 2023 he was a coinvestigator on four different projects funded by the Canadian Institutes of Health Research.</span></em></p>Pharmaceutical and insurance industries that could lose profit through lower drug prices are not happy that a pharmacare bill is planned for fall. They are speaking out and mobilizing their allies.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, CanadaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2097662023-07-17T21:52:04Z2023-07-17T21:52:04ZHigh drug prices in Canada are just one side of a bad equation<figure><img src="https://images.theconversation.com/files/537866/original/file-20230717-241434-8l70pi.jpg?ixlib=rb-1.1.0&rect=310%2C525%2C4751%2C3302&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Canadians pay high drug prices, but the pharmaceutical industry claims it is a 'key partner in economic resilience, recovery and growth.'</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><iframe style="width: 100%; height: 100px; border: none; position: relative; z-index: 1;" allowtransparency="" allow="clipboard-read; clipboard-write" src="https://narrations.ad-auris.com/widget/the-conversation-canada/high-drug-prices-in-canada-are-just-one-side-of-a-bad-equation" width="100%" height="400"></iframe>
<p>The Canadian health-care system is under pressure as <a href="https://nationalpost.com/news/canada/the-life-boat-is-full-why-canadas-entire-health-care-system-is-failing">service levels decline</a> while <a href="https://www.cihi.ca/en/national-health-expenditure-trends-2022-snapshot">costs escalate</a>. Drugs are one of our <a href="https://www.cihi.ca/en/national-health-expenditure-trends-2022-snapshot">largest health-care expenditures</a>. A federal agency, the Patented Medicine Prices Review Board (PMPRB), is supposed to <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/legislation/about-guidelines/guidelines.html">control drug prices</a> for Canadians. </p>
<p>However, the last year has been marked by upheavals which prevented the PMPRB from enacting a <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/consultations/2022-proposed-updates-guidelines.html">proposed series of reforms</a> that would have saved Canadians billions of dollars. </p>
<p>Innovative Medicines Canada (IMC), an advocacy group for the brand name pharmaceutical industry, <a href="https://innovativemedicines.ca/resources/all-resources/suspension-reformulation-pmprb-guidelines-urgently-required-imc-response-pmprb-2022-guidelines-proposals/">lobbied extensively</a> to quash these reforms. Its lobbying campaign was one of several key events which prompted <a href="https://www.ourcommons.ca/DocumentViewer/en/44-1/HESA/meeting-65/evidence">parliamentary hearings</a> and concerns over <a href="https://www.cmaj.ca/content/195/10/E378">political interference</a> with the activities of the PMPRB. </p>
<p>The result of these upheavals is that Canadians do not currently have a fully functional body protecting their best interests around drug prices.</p>
<p>However, drug prices are just one side of the equation. We must also look at pharmaceutical investment to understand the impact of the industry on the Canadian economy. </p>
<h2>Pharma industry in Canada</h2>
<p>Not surprisingly, IMC paints the contribution of its members in a positive light, recently publishing a <a href="https://innovativemedicines.ca/newsroom/all-news/canadas-rd-pharmaceutical-sector-a-key-partner-in-economic-resilience-recovery-and-growth/">press release</a> highlighting Canada’s research and development (R&D) pharmaceutical sector as “a key partner in economic resilience, recovery and growth.” IMC used data from <a href="https://www150.statcan.gc.ca/n1/pub/11-621-m/11-621-m2023001-eng.pdf">Statistics Canada</a> to show how pharmaceutical investment in Canada compares to other countries.</p>
<figure class="align-center ">
<img alt="Green capsules coming off a manufacturing line" src="https://images.theconversation.com/files/537888/original/file-20230717-230628-45bhv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/537888/original/file-20230717-230628-45bhv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=338&fit=crop&dpr=1 600w, https://images.theconversation.com/files/537888/original/file-20230717-230628-45bhv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=338&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/537888/original/file-20230717-230628-45bhv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=338&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/537888/original/file-20230717-230628-45bhv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=424&fit=crop&dpr=1 754w, https://images.theconversation.com/files/537888/original/file-20230717-230628-45bhv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=424&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/537888/original/file-20230717-230628-45bhv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=424&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Drug prices are just one side of the equation. We must also look at pharmaceutical investment to understand the impact of the industry on the Canadian economy.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Reports in <a href="https://breachmedia.ca/pharma-lobby-paid-statistics-canada-reports-used-industry-pr-push/">news media</a> and <a href="https://doi.org/10.12927/hcpol.2023.27037">scientific publications</a>, including one by <a href="https://www.cmaj.ca/content/re-pharmaceutical-industry-spending-rd-canada">one of us</a>, have expressed concerns about the data used and the degree of influence that IMC had over the published Statistics Canada report. </p>
<p>Other sources such as the <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2021.html">PMPRB annual report</a>, which includes pharmaceutical market statistics from the <a href="https://www.oecd.org/health/health-systems/pharmaceuticals.htm">Organization for Economic Co-operation and Development (OECD)</a>, cite lower numbers for the economic impact of the industry. However, disputes over absolute numbers do not need to be resolved, because the relative numbers can help us understand how the economic benefits to Canada from the pharmaceutical sector compare with peer countries.</p>
<h2>High drug prices in Canada</h2>
<p>Depending on the source, patented medicine prices in Canada are either <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2021.html#a6">fourth-</a> or <a href="https://www.canada.ca/en/health-canada/services/health-care-system/pharmaceuticals/costs-prices.html">third-highest</a> in the OECD (surpassed only by Germany, Switzerland and the United States), averaging <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2021.html#a6">18 per cent above the OECD average</a>. </p>
<p>Some authors suggest our small market and fragmented administration of health care by 13 different provinces and territories <a href="https://doi.org/10.12927/hcpap.2023.27000">contribute to high drug prices</a>.</p>
<p>However, when comparing the ratio of Canadian drug prices with those of <a href="https://www.statista.com/statistics/496169/price-ratio-canadia-to-foreign-drug-prices/">smaller countries</a> like Australia (price ratio 0.71 compared to Canada), and the Netherlands (price ratio 0.77 compared to Canada), it is clear that small market size does not automatically mean high drug prices.</p>
<p>Other countries with publicly funded health-care systems also have better prices, including the <a href="https://www.statista.com/statistics/496169/price-ratio-canadia-to-foreign-drug-prices/">United Kingdom</a> (price ratio 0.87). <a href="https://stats.oecd.org/index.aspx?DataSetCode=HEALTH_PHMC">Pharmaceutical sales data from 2020</a> shows that Canada spent US$723 per person per year on drugs, which is much higher than countries like Australia (US$447) and the Netherlands (US$368).</p>
<p>It is clear that Canada has very high drug prices relative to its peers — but what about the other side of the equation?</p>
<h2>Pharmaceutical investment and the Canadian economy</h2>
<p>Pharmaceutical trade balance is one indicator of the economic impact of the industry. Data from the industry itself shows the trade balance is positive for the European Union (EU) (<a href="https://efpia.eu/media/637143/the-pharmaceutical-industry-in-figures-2022.pdf">US$429.62 per person</a>) and also positive for individual countries with higher drug prices like Germany and Switzerland. Contrast this with the negative pharmaceutical trade balance in Canada, where the deficit was estimated at <a href="https://www150.statcan.gc.ca/n1/pub/11-621-m/11-621-m2023001-eng.pdf">US$351.14 per person</a> and increasing.</p>
<p>Canada fares better when looking at pharmaceutical employment. <a href="https://efpia.eu/media/637143/the-pharmaceutical-industry-in-figures-2022.pdf">Its own statistics</a> suggest the pharma industry provides one job for every 628 people in the EU overall. Looking at specific countries, it is not surprising that Switzerland has the highest level of pharmaceutical employment (one job for 185 people) but Germany (one job for 720 people) and France (one job for 682 people) also benefit.</p>
<p>Although <a href="https://innovativemedicines.ca/newsroom/all-news/canadas-rd-pharmaceutical-sector-a-key-partner-in-economic-resilience-recovery-and-growth/">IMC touts a figure of 107,000 Canadian jobs</a>, a look at the source from <a href="https://www150.statcan.gc.ca/n1/pub/11-621-m/11-621-m2023001-eng.pdf">Statistics Canada</a> shows that this includes both direct and indirect jobs. Still, the 49,403 direct jobs provided to Canadians by the pharmaceutical sector translates into one job for 774 people which is comparable with other countries.</p>
<h2>Investment in pharma R&D in Canada</h2>
<p>Not comparable however is the level of R&D investment. <a href="https://innovativemedicines.ca/newsroom/all-news/canadas-rd-pharmaceutical-sector-a-key-partner-in-economic-resilience-recovery-and-growth/">IMC cites a figure</a> of CAD$2.4 billion. However this figure differs from the <a href="https://www150.statcan.gc.ca/n1/pub/11-621-m/11-621-m2023001-eng.pdf">source data</a>, which actually provides an estimated range CAD$1.8-2.4 billion, and includes spending by the entire industry, not just IMC members.</p>
<figure class="align-center ">
<img alt="Collage showing a scientist in safety glasses and face mask, a bottle of capsules and molecules" src="https://images.theconversation.com/files/537890/original/file-20230717-231587-itq97k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/537890/original/file-20230717-231587-itq97k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=335&fit=crop&dpr=1 600w, https://images.theconversation.com/files/537890/original/file-20230717-231587-itq97k.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=335&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/537890/original/file-20230717-231587-itq97k.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=335&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/537890/original/file-20230717-231587-itq97k.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=421&fit=crop&dpr=1 754w, https://images.theconversation.com/files/537890/original/file-20230717-231587-itq97k.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=421&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/537890/original/file-20230717-231587-itq97k.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=421&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">The ratio of pharmaceutical research and development to sales in Canada is the lowest among comparator countries.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>The ratio of R&D to sales is another way to gauge the economic impact of the industry. The <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2021.html#a6">PMPRB</a> noted that Canada had the worst ratio among comparator countries at 3.9 per cent. Countries with lower drug prices had ratios two to six times better than Canada (France 15.2 per cent, Italy 6.6 per cent, Sweden 25.6 per cent, United Kingdom 23.4 per cent), as did those with higher drug prices (Germany 20.9 per cent, United States 23.4 per cent, Switzerland 115.4 per cent).</p>
<p><a href="https://innovativemedicines.ca/newsroom/all-news/canadas-rd-pharmaceutical-sector-a-key-partner-in-economic-resilience-recovery-and-growth/">IMC disputes</a> the PMPRB estimates claiming they are based on an outdated definition of R&D. But even using figures from the <a href="https://www150.statcan.gc.ca/n1/pub/11-621-m/11-621-m2023001-eng.pdf">Statistics Canada publication</a> endorsed by IMC, its membership was spending <a href="https://www.cmaj.ca/content/re-pharmaceutical-industry-spending-rd-canada">5.6 per cent to 7.9 per cent of revenue on R&D</a>, putting Canada perhaps marginally ahead of Italy but well behind the other comparator countries.</p>
<p>Looking at both sides of the equation then, Canadians pay very high absolute drug prices and receive lower economic benefits relative to our peers.</p>
<h2>Realistic goals for Canadian drug prices and pharma industry</h2>
<p>Canada has traditionally been a <a href="https://natural-resources.canada.ca/science-and-data/data-and-analysis/key-facts-and-figures-on-the-natural-resources-sector/16013">resource-based economy</a>. Enhancing other economic avenues takes time and consistent government policies. It is not reasonable to expect pharmaceutical investment in Canada sufficient to match R&D to sales ratios with countries like Switzerland where pharmaceuticals are a major contributor to GDP. </p>
<p>However, Canada could try to achieve a balance of investment and prices closer to norms for similar countries. Using the median of <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/are-you-patentee/current/sources-foreign-prices-pmprb7.html">the countries PMPRB uses as comparators</a>, this would mean improving the <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2021.html#a6">ratio of R&D to sales by five-fold</a>.</p>
<p>Building on lessons learned from the pandemic, the federal government initiated a <a href="https://ised-isde.canada.ca/site/biomanufacturing/en/canadas-biomanufacturing-and-life-sciences-strategy">Biomanufacturing and Life Sciences Strategy</a> to “rebuild our biomanufacturing sector, and support our innovative and world-leading scientists.” </p>
<p>To ensure that Canadians receive similar benefits from the pharmaceutical industry as other countries, we need oversight of both sides of the equation: drug prices (which requires a renewed PMPRB fully protected from political influence), and follow-up to ensure any government programs intended to offer investment incentives for the pharmaceutical industry in the Canadian economy achieve their goals.</p><img src="https://counter.theconversation.com/content/209766/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Sandra Sirrs has received funding from CADTH and Health Canada for consultative services. She is affiliated with a provincial health authority in British Columbia. No funding support was received for this article. </span></em></p><p class="fine-print"><em><span>In 2019-2023, Joel Lexchin received payments for writing briefs on the role of promotion in generating prescriptions for two legal firms. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p>Canadians pay very high drug costs, but Canada also does not receive the same economic benefits from pharmaceutical industry investments as other countries do.Sandra Sirrs, Clinical Professor, UBC Division of Endocrinology, University of British ColumbiaJoel Lexchin, Professor Emeritus of Health Policy and Management, York University, CanadaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2074632023-06-26T19:51:26Z2023-06-26T19:51:26ZCanada’s misguided changes to drug regulation could fast-track unproven medications and divert funds from other health needs<p>The Canadian government is proposing a new “<a href="https://canadagazette.gc.ca/rp-pr/p1/2022/2022-12-17/html/reg1-eng.html">Agile Licensing</a>” framework to expedite pre-market regulation of pharmaceuticals. While Health Minister Jean-Yves Duclos claims this is part of the government’s strategy to offer Canadians “<a href="https://www.ourcommons.ca/DocumentViewer/en/44-1/HESA/meeting-64/evidence">access to quality and affordable medicines</a>,” the policy is likely to cause more harm than good.</p>
<p>Adoption of Agile Licensing would allow companies to market drugs up to six months earlier than under the current system. Fewer pre-market clinical trials would be required as long as firms continue studying their drugs’ effectiveness after they are already in use.</p>
<p>The government suggests this new approach will significantly improve Canadians’ quality of life, estimating the value of this improvement at <a href="https://canadagazette.gc.ca/rp-pr/p1/2022/2022-12-17/html/reg1-eng.html">$302 million over ten years</a>. However, the assumptions behind this estimate are flawed.</p>
<h2>Flawed assumptions</h2>
<p>By design, Canada will have less information about the risks of new medicines if those drugs enter the market with less pre-market clinical data. This will become a problem if a company fails to conduct promised post-market studies or if Health Canada does not remove unsafe or ineffective medicines from the market. </p>
<p>Unfortunately, <a href="https://doi.org/10.1136/bmj.n1898">the experience in the United States</a> shows that many fast-tracked drugs are not adequately studied after they are approved for sale and few are removed from the market, even if evidence shows they do not perform as suggested by their “promising” but incomplete pre-market trials.</p>
<p>Fast-tracking market approval for new, less-studied medicines is not only potentially wasteful in the first instance; it will inevitably divert money away from other uses in the health-care system to pay for costly but unproven drugs.</p>
<p>New medicines are (<a href="https://doi.org/10.1136%2Fbmj.38582.703866.AE">and have long been</a>) the primary driver of increasing spending on prescription drugs, for both private and public drug plans. In terms of budgets, new drugs do not simply replace older ones; <a href="https://www.canada.ca/en/patented-medicine-prices-review/news/2023/01/increased-use-of-higher-cost-medicines-continues-to-put-pressure-on-canadian-public-drug-plans.html">they increase the overall drug budget</a>, which necessarily means foregone opportunities to use those funds in other sectors of health care, such as improving access to joint replacements, nursing homes or mental health care.</p>
<p>There is a major flaw in Health Canada’s cost-benefit analysis of Agile Licensing: it overlooks the fact that accelerated access to — and therefore spending on — “promising” new medicines means less money for other forms of health care that Canadians need. </p>
<h2>Affordability</h2>
<p>Despite the Minister of Health’s assertions, the proposed framework contains no mechanism for making fast-tracked medicines “affordable.” This is extremely worrisome given the drugs that will be fast-tracked by this policy are patented, specialized medicines likely to be priced at levels that are unaffordable and <a href="https://doi.org/10.1136/bmj.l4627">arguably indefensible</a>.</p>
<p>Patents are government-granted time-limited monopolies that can stimulate innovation. However, they can also enable manufacturers of specialized medicines to charge exorbitant prices due to the life-or-death situations faced by patients who need such treatments. Pharmaceutical companies are using this market power to charge extraordinarily high prices with increasing frequency.</p>
<p>Before 2006, only four drugs approved in Canada had annual prices above $50,000 per patient — which is clearly a lot of money. Today, however, 67 medicines carry such a price tag, costing Canadians over <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2021.html">$3 billion per year</a> in total. Seven drugs now available in Canada are priced at an astonishing <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/npduis/analytical-studies/chartbook/expensive-drugs-rare-diseases-2011-2020.html">$1 million per patient</a>.</p>
<p>Higher drug prices do not guarantee more value or improvements to health and well-being. <a href="https://doi.org/10.1007/s40273-021-01087-6">Studies show</a> it typically costs <a href="http://www.pmprb-cepmb.gc.ca/CMFiles/Consultations/new_guidelines/Canada_report_2018-03-14_Final.pdf">around $30,000</a> to produce a measurable improvement in the health of one person, for one year in health-care systems like ours. However, new patented medicines often require hundreds of thousands of dollars for the same benefit.</p>
<h2>The harms of high drug prices</h2>
<p>This discrepancy between reasonable prices for generating health benefits and the prices charged for many new patented medicines indicates a failing system. It directly harms Canadians by preventing access to therapies due to prohibitive pricing, and it indirectly harms them by diverting funds from more effective investments that would yield greater health benefits per dollar spent.</p>
<p>Before fast-tracking drug approvals so that manufacturers can increase sales, policymakers should develop and enforce measures to ensure the prices charged will fall within reasonable limits. Unfortunately, the Canadian government recently <a href="https://doi.org/10.1016/S0140-6736(23)00956-X">backed down</a> from reforms that would have done just that.</p>
<p>Without a policy to ensure reasonable pricing of fast-tracked medicines, the government’s proposed Agile Licensing regulations will only hasten access to unproven therapies while drawing resources away from other forms of health care that Canadians need and that offer better value for money spent.</p><img src="https://counter.theconversation.com/content/207463/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Steven G. Morgan has received research funding from the Canadian Institutes of Health Research (CIHR), Health Canada, and other public organizations.</span></em></p><p class="fine-print"><em><span>Aidan Hollis receives funding from Canadian Institutes of Health Research (CIHR) and Hong Kong RGC Senior Research Fellowship Scheme. He is President of Incentives for Global Health. </span></em></p><p class="fine-print"><em><span>Christopher McCabe was previously CEO of The Institute of Health Economics, Alberta, which received research funding from a number of pharmaceutical companies during his tenure, including Astra Zeneca, Boerhinger Ingleheim, GSK, Novartis, Roche and Takeda.</span></em></p><p class="fine-print"><em><span>Matthew Herder receives funding from the Canadian Institutes of Health Research (CIHR), the Public Health Agency of Canada, and the not-for-profit foundation Arnold Ventures. He was previously a member of the Patented Medicine Prices Review Board (PMPRB), and received honoraria for his public service. </span></em></p><p class="fine-print"><em><span>Mike Paulden receives funding from the Canadian Institutes of Health Research (CIHR). He previously chaired a technical working group at the Patented Medicine Prices Review Board (PMPRB), and was a founding member of the Health Economics Advisory Council at the Canadian Agency for Drugs and Technologies in Health (CADTH).</span></em></p>The federal government’s proposed Agile Licensing drug approval regulations mean Canada will have less information about the risks of new medicines, and higher costs.Steven G. Morgan, Professor, School of Population and Public Health, University of British ColumbiaAidan Hollis, Professor of Economics, University of CalgaryChristopher McCabe, Professor of Health Economics, Queen's University BelfastMatthew Herder, Director of the Health Law Institute at the Schulich School of Law, Dalhousie UniversityMike Paulden, Associate professor, School of Public Health, University of AlbertaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1946962023-06-09T12:29:31Z2023-06-09T12:29:31Z‘From Magic Mushrooms to Big Pharma’ – a college course explores nature’s medicine cabinet and different ways of healing<figure><img src="https://images.theconversation.com/files/531019/original/file-20230608-20480-dlan6s.jpg?ixlib=rb-1.1.0&rect=428%2C512%2C4455%2C2984&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">People for millennia have used what grows around them as medicine.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/dangerous-mushroom-royalty-free-image/463172611">LorenzoT81/iStock via Getty Images Plus</a></span></figcaption></figure><figure class="align-right ">
<img alt="Text saying: Uncommon Courses, from The Conversation" src="https://images.theconversation.com/files/499014/original/file-20221205-17-kcwec8.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/499014/original/file-20221205-17-kcwec8.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=375&fit=crop&dpr=1 600w, https://images.theconversation.com/files/499014/original/file-20221205-17-kcwec8.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=375&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/499014/original/file-20221205-17-kcwec8.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=375&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/499014/original/file-20221205-17-kcwec8.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=471&fit=crop&dpr=1 754w, https://images.theconversation.com/files/499014/original/file-20221205-17-kcwec8.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=471&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/499014/original/file-20221205-17-kcwec8.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=471&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<p><em><a href="https://theconversation.com/topics/uncommon-courses-130908">Uncommon Courses</a> is an occasional series from The Conversation U.S. highlighting unconventional approaches to teaching.</em> </p>
<h2>Title of course:</h2>
<p>“From Magic Mushrooms to Big Pharma”</p>
<h2>What prompted the idea for the course?</h2>
<p>I’m from the foothills of the Appalachians in southern Ohio, where my Grandma Mildred would go out into the woods, which she called her medicine cabinet, to find herbs to use as medicine. <a href="https://scholar.google.com/citations?user=DhbiqSMAAAAJ&hl=en&oi=ao">I grew up to be an anthropologist</a>, interested in how people around the world heal themselves. In the 1990s, I did my dissertation research in Ecuador and learned how Indigenous people in the Choco region used <a href="https://doi.org/10.1007/s00213-019-05446-2">ayahuasca and other medicines from the forest</a> to assist in the grieving process.</p>
<p>With the <a href="https://mjbizdaily.com/map-of-us-marijuana-legalization-by-state/">legalization of cannabis in many states</a> and <a href="https://doi.org/10.3390/jof8080870">increased research</a> on <a href="https://doi.org/10.1007/s13311-017-0542-y">how “nontraditional” drugs can assist</a> people with post-traumatic stress disorder, depression and <a href="https://doi.org/10.2174/15733998113099990003">addiction issues</a>, it seemed like an opportune time to create this course. It’s part of a new interdisciplinary minor at Western Illinois University called “<a href="http://www.wiu.edu/academics/cannabis/culture/">Cannabis & Culture</a>” that offers students a foundation for understanding the social and cultural context, history and politics of nature-based medicine use in the United States and around the globe.</p>
<h2>What does the course explore?</h2>
<p>The course looks at how different peoples and cultures use nature-based medicines to heal themselves. First we establish that there are <a href="https://doi.org/10.1038/sj.embor.7400693">many ways of knowing the world around us</a>, just as there are many ways to heal ourselves. Some of us rely on Western medicine, others pray, yet others turn to Indigenous or traditional ways of healing that are rooted in nature.</p>
<p>We talk about the ways Western medicine now seeks to validate substances that have been used for healing for centuries, like research into how <a href="https://doi.org/10.3390/molecules27123877">ginger and turmeric can alleviate inflammation</a>, or the ways cannabis can <a href="https://doi.org/10.1016/j.yebeh.2016.09.040">reduce or even eliminate some epileptic seizures</a>.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/530983/original/file-20230608-27-tlrr54.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="closeup of five dots of blood on the shoulder of a man without a shirt" src="https://images.theconversation.com/files/530983/original/file-20230608-27-tlrr54.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/530983/original/file-20230608-27-tlrr54.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/530983/original/file-20230608-27-tlrr54.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/530983/original/file-20230608-27-tlrr54.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/530983/original/file-20230608-27-tlrr54.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/530983/original/file-20230608-27-tlrr54.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/530983/original/file-20230608-27-tlrr54.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Kambô frog medicine is a shamanic medicinal ritual that originates among Amazonian tribes who use the poisonous excretion from the <em>Phyllomedusa bicolor</em> tree frog to cure illness.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/kambo-frog-poison-medicine-for-body-detox-royalty-free-image/1065635962">GummyBone/iStock via Getty Images Plus</a></span>
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<p>We also examine how the <a href="https://doi.org/10.1111/j.1471-8847.2006.00168.x">pharmaceutical industry has</a> <a href="https://www.northatlanticbooks.com/shop/biopiracy/">exploited Indigenous peoples’ ethnobotanical knowledge</a> <a href="https://doi.org/10.1155/2021/8898842">and landscapes for monetary gain</a>.</p>
<p>Using the Amazonian giant leaf frog, or kambô (<em><a href="https://amphibiaweb.org/cgi/amphib_query?where-genus=Phyllomedusa&where-species=bicolor&account=amphibiaweb">Phyllomedusa bicolor</a></em>), as a case study, students learn that at least 15 Indigenous groups have long histories of using the frog’s secretion for its analgesic, antibiotic and wound-healing properties. <a href="https://news.mongabay.com/2022/05/amazon-frog-highlights-appropriation-of-indigenous-knowledge-for-commercial-gain/">Eleven patents related to <em>P. bicolor</em> have been granted</a> – all of them in rich countries. Indigenous people have not been compensated for their knowledge.</p>
<h2>Why is this course relevant now?</h2>
<p>The current generation of young people are <a href="https://magazine.medlineplus.gov/article/teens-are-talking-about-mental-health">open about mental health issues</a>, and many people are looking for new ways to deal with anxiety, grief, PTSD and depression. My students can discuss their health concerns and learn about alternatives to what they may be accustomed to.</p>
<p>At this politically and racially polarized moment in the U.S., the course also provides the opportunity to discuss how <a href="https://doi.org/10.1089/can.2019.0063">racism, misogyny and discrimination against people of color</a> have influenced scientific research.</p>
<h2>What’s a critical lesson from the course?</h2>
<p>Over the course of the semester, students begin to recognize that there is no one right way of healing. More importantly, there is no one right way of being human. It is my hope that students leave seeing that everything is connected, integrally linked to humanity’s relationship to nature. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/531020/original/file-20230608-17666-2vej3s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="rows of marijuana crop inside a greenhouse with two agricultural workers" src="https://images.theconversation.com/files/531020/original/file-20230608-17666-2vej3s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/531020/original/file-20230608-17666-2vej3s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/531020/original/file-20230608-17666-2vej3s.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/531020/original/file-20230608-17666-2vej3s.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/531020/original/file-20230608-17666-2vej3s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/531020/original/file-20230608-17666-2vej3s.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/531020/original/file-20230608-17666-2vej3s.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">In some parts of the U.S., cannabis is now just another agricultural crop.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/large-amounts-and-endless-rows-of-marijuana-crop-stand-news-photo/1254375856">Mark Abramson/The Washington Post via Getty Images</a></span>
</figcaption>
</figure>
<h2>What materials does the course feature?</h2>
<ul>
<li><p>Scientific materials provided by the <a href="https://maps.org/">Multidisciplinary Association for Psychedelic Studies</a>, a nonprofit that provides some of the only scientific research on psychedelics in the U.S. and promotes awareness of these drugs</p></li>
<li><p>“<a href="https://www.penguinrandomhouse.com/books/529343/how-to-change-your-mind-by-michael-pollan/">How to Change your Mind</a>,” by Michael Pollan and the accompanying <a href="https://www.imdb.com/title/tt21062540/">Netflix series</a> </p></li>
<li><p>Work of ethnobotanist Mark Plotkin, including his Ted Talk “<a href="https://www.ted.com/talks/mark_plotkin_what_the_people_of_the_amazon_know_that_you_don_t?language=en">What the people of the Amazon know that you don’t</a>”</p></li>
</ul>
<h2>What will the course prepare students to do?</h2>
<p>Studying how different cultures approach problems that plague all humans, like being sick and healing our ill, demonstrates to students that there are many ways the world over to solve problems. This course views different approaches not as a problem to be overcome but as a resource that can yield new ways of thinking and new opportunities – a definite advantage in the professional world. I hope students also learn to become advocates for their own health and well-being.</p><img src="https://counter.theconversation.com/content/194696/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Heather McIlvaine-Newsad does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>An anthropology course explores how peoples and cultures around the world use nature-based medicines to heal.Heather McIlvaine-Newsad, Professor of Anthropology, Western Illinois UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2047872023-05-04T20:39:52Z2023-05-04T20:39:52ZHealth Canada should be transparent about how it’s monitoring drug safety<figure><img src="https://images.theconversation.com/files/524019/original/file-20230503-26-zdm4om.jpg?ixlib=rb-1.1.0&rect=586%2C439%2C5165%2C3388&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">When regulatory agencies like Health Canada approve a new drug, they require the drug company to continue monitoring the product's safety.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><iframe style="width: 100%; height: 100px; border: none; position: relative; z-index: 1;" allowtransparency="" allow="clipboard-read; clipboard-write" src="https://narrations.ad-auris.com/widget/the-conversation-canada/health-canada-should-be-transparent-about-how-it-s-monitoring-drug-safety" width="100%" height="400"></iframe>
<p>Regulatory bodies like Health Canada are intended to ensure that approved drugs go through a rigorous multi-stage process. However, clinical trials can’t detect every side-effect or risk. </p>
<p>Once new drugs are approved for marketing in Canada, Health Canada continues to monitor them. This is to determine if the health benefits identified in pre-market trials hold up to further scrutiny, new safety issues arise or known ones are more serious than initially anticipated, and if the drugs are being used outside of their approved uses and populations. </p>
<p>All of that information is important for doctors and pharmacists and for people who will be using the drugs and should be publicly available.</p>
<h2>Clinical trials</h2>
<p>Potential new drugs are assessed in <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/guidance-documents/guidance-drugs-clinical-trials-human-subjects-gui-0100.html">clinical trials</a> before they can be authorized for sale in Canada. But in order to make it easier to clearly identify if the drugs are beneficial, these trials only enrol a very selective group of patients. </p>
<p>For example, people who are accepted into these trials need to have a definite diagnosis, they should only be suffering from the disease the drug is intended to treat, they shouldn’t be taking other drugs, they may have to live near the site where the testing is ongoing — and the exclusions go on. </p>
<p>By one estimate, <a href="https://doi.org/10.1176/appi.ajp.159.3.469">out of a potential 346 patients only 29</a> or fewer than 10 per cent, qualified for a trial looking at treating major depression. In addition, <a href="https://deainfo.nci.nih.gov/advisory/ctac/archive/0309/presentations/Williams_030409.pdf">clinical trials often leave out</a> children, the elderly, women, minority groups, people with disabilities and multiple other groups.</p>
<p>Usually <a href="https://www.healthline.com/health/clinical-trial-phases#phase-ii">only 3,000 to 5,000 people</a> are exposed to an experimental drug in clinical trials. The much larger trials conducted for the COVID-19 vaccines, <a href="https://www.nih.gov/news-events/news-releases/peer-reviewed-report-moderna-covid-19-vaccine-publishes">involving 30,000</a> to <a href="https://www.pfizer.com/science/coronavirus/vaccine/about-our-landmark-trial">46,000 people</a>, were an exception to this. </p>
<figure class="align-center ">
<img alt="White pills spilling out of a bottle forming the shape of a question mark against a pink background" src="https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">When drugs are finally approved, there are still unanswered safety questions, including about how drugs will affect demographic groups who were left out of the trials.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Previous research has shown that in order to detect rare side-effects, a trial needs to use the <a href="https://blogs.bmj.com/bmjebmspotlight/2017/11/14/rare-adverse-events-clinical-trials-understanding-rule-three/">statistical rule of three</a>: For example, if a side-effect affects one in 1,000 patients, a trial would have to enrol at least 3,000 people (three x 1,000) to have a 95 per cent chance of seeing even a single case. This means that rare safety issues may be missed entirely. </p>
<p>The result is that when drugs are finally approved, there are still unanswered safety questions, including about how drugs will affect demographic groups who were left out of the trials.</p>
<h2>Drug safety programs</h2>
<p>That’s why when regulatory agencies like Health Canada approve a drug, they require the drug company to monitor post-market safety. These programs go by various names; in <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-document-submission-risk-management-plans-follow-commitments.html">Canada</a> and <a href="https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pharmacovigilance/risk-management/risk-management-plans">Europe</a> they are Risk Management Plans (RMP) and in the United States they are <a href="https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems">Risk Evaluation and Mitigation Strategies</a> (REM). </p>
<p>Canada’s current RMP system has been in place <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-document-submission-risk-management-plans-follow-commitments.html">since 2009</a>. According to <a href="https://www.canada.ca/en/health-canada/programs/consultation-proposed-agile-regulations-guidance-licensing-drugs-medical-devices/submitting-risk-management-plans.html">Health Canada documents</a>, RMPs are mandatory when there is a significant degree of uncertainty respecting the risks associated with a particular drug or when a drug “presents a serious risk of injury to human health that warrants measures … to reduce the probability or severity of such an injury.”</p>
<p>All new drugs that have never before been sold in Canada in any form, as well as all opioids, require RMPs to help safeguard the public. </p>
<p><a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/profile-guidance-document-submission-risk-management-plans-follow-commitments/notice-clarification-drug-manufacturers-sponsors.html">Under these plans</a> companies may have to conduct additional safety studies, set up registries to identify patients who are taking the drug, develop educational materials for health care professionals and/or patients, restrict access to the drug and commit to undertaking a number of other measures.</p>
<p>RMPs are not perfect and won’t resolve all the safety uncertainties about new drugs. <a href="https://doi.org/10.1038/clpt.2014.184">One European study</a> estimated that after five years, only about one in five issues was settled. More definitely needs to be done to monitor post-market safety. </p>
<p>But RMPs are still a significant tool. Issues that remained unresolved in some cases were whether theoretical risks were actually seen in practice and whether there was enough information to determine if long-term data revealed new safety concerns.</p>
<h2>Access to drug monitoring information</h2>
<p>Doctors who prescribe drugs, pharmacists who fill prescriptions, researchers who study drug safety and especially patients who take the drugs all should have a right to know how safety is being monitored. </p>
<p>In the U.S., people can turn to a <a href="https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm">Food and Drug Administration website</a> that lists all the drugs with REMS. There they can read about the goals of the REMS, a summary of the measures included in it, look at the materials that have been developed and how the effectiveness of the REMS plan is going to be assessed. </p>
<p>In European countries like <a href="https://laegemiddelstyrelsen.dk/en/licensing/licensing-of-medicines/medicines-authorised-with-a-summary-of-the-risk-management-plan/">Denmark there is a similar list of drugs</a> with a RMP. Click on a hyperlink and it takes you to a summary of the RMP for the drug in question.</p>
<p>Health Canada currently has no such website, and acknowledges that <a href="https://nlpb.ca/media/Health-Canada_QA-for-HCP_RMP_EN_Updated_2022-07-07.pdf">this is an information gap</a>. Two of <a href="https://www.canada.ca/en/health-canada/programs/consultation-proposed-agile-regulations-guidance-licensing-drugs-medical-devices/submitting-risk-management-plans.html">Health Canada’s stated goals</a> in implementing a system of RMPs are to “support Canadians’ timely access to safe, efficacious and high quality drugs and support ongoing evaluation of information that could have an impact on the benefit-risk profile of health products.” </p>
<p>But without access to current information on specific drugs, Canadians cannot assess those risks for themselves, nor can they evaluate the monitoring program. </p>
<p>On top of this lack of transparency, <a href="https://shpm.info.yorku.ca/files/2020/09/Health-Canada-funding-distribution-2004-2020.pdf">Health Canada spends only one-third as much money and has only one-third as many employees</a> monitoring drug safety compared to the amount of money and the number of people who are involved in approving new drugs.</p>
<p>Since February 2019, Health Canada has been a world leader in <a href="https://www.bmj.com/content/365/bmj.l1825">releasing the information that it used in deciding to approve new drugs</a>. It has a <a href="https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review.html?_ga=2.233746589.2014837886.1506726303-1326787507.1398655537#_Submissions_currently_under">website</a> that lists drugs that weren’t approved and what drugs it’s considering for approval. There is a <a href="https://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=B68C1BAF-1">website with RMPs for substances that are harmful</a> to the environment and human health, albeit with data from 2016. </p>
<p>It’s time for Health Canada to do the same for drug RMPs. <a href="https://canadagazette.gc.ca/rp-pr/p1/2022/2022-12-17/html/reg1-eng.html">When Canada’s Food and Drugs Act regulations are amended</a>, transparency for drug RMPs needs to be made mandatory. But Health Canada does not need to wait until then to make this information available to Canadians.</p><img src="https://counter.theconversation.com/content/204787/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2019-2022, Joel Lexchin received payments for writing briefs on the role of promotion in generating prescriptions for two legal firms. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p>Health Canada continues to monitor newly approved drugs to determine if the benefits identified in the pre-market trials hold up to further scrutiny. Canadians need better access to that information.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, CanadaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2025272023-03-29T09:06:46Z2023-03-29T09:06:46ZIndustries can harm health in many ways: here are 3 that aren’t so obvious<figure><img src="https://images.theconversation.com/files/517863/original/file-20230328-18-pfw5ql.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Research confirms the adverse effects of social media on mental health.</span> <span class="attribution"><span class="source">Shutterstock </span></span></figcaption></figure><p>A recent ground-breaking <a href="https://www.thelancet.com/series/commercial-determinants-health">series of reports</a> in the science journal The Lancet unpacks what commercial determinants of health are, and how they affect public health. It uses a new, broader definition of the determinants: </p>
<blockquote>
<p>the systems, practices and pathways through which commercial actors drive health and equity. </p>
</blockquote>
<p>Some commercial entities contribute positively to health and society. However, <a href="https://www.bmj.com/company/newsroom/new-evidence-links-ultra-processed-foods-with-a-range-of-health-risks/">research</a> shows that some commercial products and practices are directly linked to avoidable ill health, planetary damage, and social and health inequity. Large transnational corporations are especially to blame.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/profit-versus-health-4-ways-big-global-industries-make-people-sick-202368">Profit versus health: 4 ways big global industries make people sick</a>
</strong>
</em>
</p>
<hr>
<p>The Lancet series examines not just directly damaging products (such as alcohol or ultra-processed foods) but the commercial practices that influence human health, inequities in health and planetary health. The series highlights the need to better understand the diversity within the commercial world, and the variety of ways its normal operations harm humanity and the planet. </p>
<h2>3 ‘hidden’ industries that can harm your health</h2>
<p>Some seemingly benign – or even beneficial – industries actually have major and avoidable impacts on health. They contribute negatively to health in subtle or indirect ways.</p>
<p>The <a href="https://journals.sagepub.com/doi/10.1177/01410768211053006">pharmaceutical industry</a> is one. Its abuse of <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32581-2/fulltext">intellectual property</a> to increase prices and limit access to essential drugs is a common trend. The pre-selling of COVID-19 vaccines to wealthy countries is a recent, massive-scale example. The industry’s longstanding resistance to lowering the price of antiretroviral drugs for HIV meant that untold thousands, mostly in developing countries, died because they lacked access to treatment. </p>
<p>Social media is another industry of particular concern especially given the increase in its consumption in recent years. A plethora of research confirms the <a href="https://www.medicalnewstoday.com/articles/social-media-and-mental-health#statistics">adverse effects of social media on mental health</a>, especially an increase in cases of depression and anxiety.</p>
<p>On top of this, other industries often use social media to promote harmful products and for “<a href="https://www.esgthereport.com/what-is-social-washing/">social washing</a>”, a strategy employed by companies to promote themselves as more socially responsible than they actually are, purely for brand promotion. We have also seen an increase in “surveillance capitalism” whereby private information is gathered through social media use. The information is then used by, for example, junk food companies through platforms such as <a href="https://economictimes.indiatimes.com/industry/cons-products/food/junk-food-brands-using-facebook-to-target-young-people/articleshow/44938881.cms">Facebook for the targeted marketing of unhealthy commodities</a>.</p>
<p>Extractive companies have also been linked to various health and planetary harms. Air and water pollution, environmental degradation, fatalities, silicosis, and noise-induced hearing loss are just a few examples of these harms. A <a href="https://www.hrw.org/news/2018/08/27/south-africa-how-mining-damages-communities-and-environment#:%7E:text=The%20South%20African%20Human%20Rights,%5Band%5D%20the%20environment.%22">report by the South African Human Rights Commission</a> has severely criticised the mining industry and held that this sector “is riddled with challenges related to land, housing, water and the environment”. </p>
<p>In the South African context, the harms created by the mining industry are particularly concerning given the knock-on, damaging socio-economic effects – for example as a result of the loss of breadwinners – on families and, often, vulnerable communities. </p>
<h2>Harmful business practices</h2>
<p>Not only can harm to global health come from a range of industries, it can also come indirectly from business practices. Three harmful practices are:</p>
<ul>
<li><p>Exploiting weak regulation in low- and middle-income countries. One example is the export of harmful <a href="https://news.bloomberglaw.com/environment-and-energy/developing-world-still-struggling-with-obsolete-pesticides">pesticides</a> to <a href="https://www.dailymaverick.co.za/article/2021-01-26-poison-on-a-plate-outdated-agrichemical-legislation-means-your-avocado-topped-pizza-could-be-hazardous-to-your-health/#:%7E:text=Paraquat%20%E2%80%94%20banned%20in%20the%20EU%2C%20available%20in%20SA&text=wearing%20protective%20equipment.-,In%20South%20Africa%2C%20the%20chemical%20is%20still%20widely%20used%2C%20not,residential%20estates%20and%20public%20places.">developing countries</a>. </p></li>
<li><p>Influencing policy agendas and actions through what appear to be <a href="https://www.theguardian.com/news/2018/may/24/the-trouble-with-charitable-billionaires-philanthrocapitalism">philanthropic activities</a>, but which benefit business rather than health. </p></li>
<li><p><a href="https://www.cnbc.com/2022/05/06/starbucks-accused-of-more-than-200-labor-violations-in-nlrb-complaint.html">Unfair labour</a> and <a href="https://www.theguardian.com/business/2022/dec/20/nike-lawsuit-records-sexual-abuse-toxic-workplace-claim">employment practices</a>.</p></li>
</ul>
<h2>Next steps</h2>
<p>Commercial determinants of health are clearly influenced by a much wider range of actors and practices than the more obvious product-related harms of the “big four” (tobacco, alcohol, ultra-processed foods and fossil fuels). No business entity is purely “good” or “bad”, but we have seen an increasing trend where companies use “beneficial” practices, such as sponsorship, donations and pledges to environmental causes, to mask harmful practices and influence politicians. </p>
<p>Without a common understanding that these industries are harming our health, no action can be taken against them. Holding industry accountable and stricter government regulation are the minimum actions needed. </p>
<p>The Lancet series authors are calling for a global move towards health-promoting models of commerce. This is a move away from emphasising profits and economic growth, and instead focusing on societal and planetary health and well-being. </p>
<p><em>This article is part of a media partnership between The Conversation Africa and PRICELESS SA, a research-to-policy unit based in the School of Public Health at the University of the Witwatersrand. Researchers from the SAMRC/Wits Centre for Health Policy and Decision Science also contributed to the Lancet series on the commercial determinants of health.</em></p><img src="https://counter.theconversation.com/content/202527/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Sameera Mahomedy does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Some commercial products and practices are directly linked to avoidable ill health, planetary damage, and social and health inequity. Large transnational corporations are especially to blame.Sameera Mahomedy, Researcher in Law and Policy, SAMRC/Centre for Health Economics and Decision Science - PRICELESS SA, University of the WitwatersrandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1973352023-01-09T19:57:15Z2023-01-09T19:57:15ZHow the pharmaceutical industry uses disinformation to undermine drug price reform<figure><img src="https://images.theconversation.com/files/503452/original/file-20230106-9978-995yzp.jpg?ixlib=rb-1.1.0&rect=0%2C94%2C5742%2C3721&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The pharma industry warned that if proposed new prescription price guidelines go ahead, drug launches would be delayed and 'Canadian patients will be deprived of potentially life-saving new medicines.'
</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>Canada’s drug prices are the <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2020.html">fourth highest in the developed world</a>. Despite this, Innovative Medicines Canada (IMC), the lobby group for Big Pharma, <a href="https://innovativemedicines.ca/newsroom/all-news/implementation-patented-medicine-prices-review-boards-proposed-guidelines-will-harm-canadian-patients/">put out a call</a> in November 2022 for the Canadian government to suspend consultations on guidelines aimed at lowering prescription drug prices. </p>
<p><a href="https://www.canada.ca/en/patented-medicine-prices-review/services/consultations/2022-proposed-updates-guidelines.html">The proposed guidelines</a> were expected to come into effect on Jan. 1, but were postponed in late December. </p>
<p>IMC warned that if the new guidelines went ahead, drug launches would be delayed and “Canadian patients will be deprived of potentially life-saving new medicines.”</p>
<p>Just a few days later, IMC took out a <a href="https://www.theglobeandmail.com/business/adv/article-shortening-the-regulatory-timeline-will-benefit-patients-and-the/">full-page ad in the <em>Globe and Mail</em></a> claiming that “Canadians wait twice as long for new medicines.” </p>
<p>The first statement is false and the second is a half-truth. Both are typical of an industry that <a href="https://www.citizen.org/article/twenty-seven-years-of-pharmaceutical-industry-criminal-and-civil-penalties-1991-through-2017/">paid US$38.6 billion in fines</a> in civil and criminal cases in the United States between 1991 and 2017.</p>
<h2>Falsehoods and half-truths</h2>
<p>IMC has been <a href="https://archive.innovativemedicines.ca/pmprb-still-time-regulations/">claiming since the end of 2020</a> that “new drugs are not being launched in Canada” because our drug prices might be lowered. However, between 2011 and 2020, there was <a href="https://doi.org/10.1016/j.healthpol.2022.08.006">no change in the timing</a> between when drugs were approved by the United States Food and Drug Administration (FDA) and then by Health Canada. </p>
<p>Drug companies did not wait longer to introduce new drugs here compared to the U.S. There was a <a href="https://doi.org/10.1016/j.healthpol.2022.08.006">decline in the per cent of drugs first approved by the FDA and then by Health Canada</a>, but the same thing happened in Australia where drug prices were not being lowered.</p>
<p>What about the claim that Canadians are losing out on new potentially life-saving drugs? </p>
<p>Only 10-15 per cent of new drugs are actually <a href="https://doi.org/10.1136/bmjopen-2018-023605">major therapeutic breakthroughs</a>. The industry claims the other 85-90 per cent <a href="https://ethics.harvard.edu/blog/new-prescription-drugs-major-health-risk-few-offsetting-advantages">give patients more choice</a>. But companies don’t test their new drugs on patients who can’t tolerate or don’t get better on older ones. So, nobody really knows if those choices mean anything positive for patients. </p>
<h2>Wait times</h2>
<figure class="align-center ">
<img alt="A piggy bank seen from above beside a prescription box" src="https://images.theconversation.com/files/503453/original/file-20230106-24-vj99yn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/503453/original/file-20230106-24-vj99yn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/503453/original/file-20230106-24-vj99yn.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/503453/original/file-20230106-24-vj99yn.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/503453/original/file-20230106-24-vj99yn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/503453/original/file-20230106-24-vj99yn.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/503453/original/file-20230106-24-vj99yn.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">For over 50 years, drug companies have been suggesting that access to medications will be at risk every time governments do something that threatens their profits.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Do Canadians wait longer for new drugs? If the comparison is to patients in the U.S. or the European Union (EU), then the answer is yes. </p>
<p>Why is the wait longer? After companies submit drugs for approval in the U.S. or the EU, <a href="https://www.cirsci.org/publications/cirs-rd-briefing-81-new-drug-approvals-in-six-major-authorities-2011-2020/">they take an extra year</a> before submitting them to Health Canada. Is that wait because of Canadian drug prices? No. Drug prices are higher in Switzerland than in Canada, but the wait to get drugs approved in Switzerland is also longer than in Canada. </p>
<p>If drug prices were the reason for the wait, then companies should be submitting applications sooner in Switzerland compared to Canada.</p>
<p>In Canada, newly approved drugs are available for people with private insurance <a href="https://doi.org/10.9778/cmajo.20220063">about a year</a> before they can be prescribed to people covered by provincial/territorial drug formularies. But a substantial proportion of that time difference is in the hands of drug companies.</p>
<p>If pharma companies want to get their drugs publicly covered, they first have to submit them to the <a href="https://www.cadth.ca/about-cadth">Canadian Agency for Drugs and Technologies in Health</a> (CADTH). CADTH then does a value-for-money audit and makes a recommendation to the provinces and territories about funding. </p>
<p>In an effort to speed up decision-making about whether the public should pay for new drugs, ever since April 2018 companies can <a href="https://doi.org/10.3389/fphar.2019.00196">submit applications to CADTH up to 180 days</a> before Health Canada approves the drugs. But instead of taking full advantage of this provision, <a href="http://doi.org/10.9778/cmajo.20220063">companies only submit a median of 13 days before approval</a>, adding 5.5 months to the time it takes to make a final decision. </p>
<h2>Protecting profits</h2>
<p>Drug companies have been making threats for over 50 years every time governments do something that threatens their profits. </p>
<p>In 1972, the NDP government of Manitoba passed a law making it mandatory for pharmacists to substitute cheaper generic drugs for those named on prescriptions, unless prohibited by the physician writing the prescription. Furthermore, the substitute could not be sold at a price higher than that of the lowest priced equivalent drug. After this legislation passed, the <a href="https://utorontopress.com/9781442619609/private-profits-versus-public-policy/">president of the industry association made a thinly veiled threat to the Manitoba government</a>:</p>
<blockquote>
<p>“It will remain to be seen how much value would be put on the Manitoba market by research-oriented companies. It is each company’s decision whether the size of their Manitoba market will merit the cost of properly servicing that market. If they can’t meet the prices they could be forced out of business.”</p>
</blockquote>
<p>After the Liberal government in Ontario passed legislation in 2017 requiring companies to report how much money they gave to doctors, hospitals and other health care personnel and institutions, <a href="https://www.theglobeandmail.com/canada/article-ford-pcs-leave-drug-company-transparency-law-in-limbo/">IMC made the same threat</a> about not launching new drugs in Canada because of the regulatory burden of having to make reports.</p>
<p>Now, they are making a similar threat based on potentially lower drug prices in Canada.</p>
<p>Drug companies make threats to maintain their ability to make <a href="https://doi.org/10.1001/jama.2020.0442">extraordinarily high profits</a>. The rest of us need to stand up for the right of patients to get drugs at affordable prices.</p><img src="https://counter.theconversation.com/content/197335/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2019-2022, Joel Lexchin received payments for writing a brief on the role of promotion in generating prescriptions for Goodmans LLP and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p>The pharma industry claims lower prescription drug prices will mean less access to new medication for Canadians. It’s an old threat that pits profits against patients’ rights to affordable drugs.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, CanadaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1898682022-12-05T13:27:20Z2022-12-05T13:27:20ZPharma’s expensive gaming of the drug patent system is successfully countered by the Medicines Patent Pool, which increases global access and rewards innovation<figure><img src="https://images.theconversation.com/files/498366/original/file-20221130-8007-d247y0.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2121%2C1412&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Drug patents don't necessarily spur companies to innovate so much as restrict access to their IP.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/medicines-and-money-the-cost-of-treatment-and-royalty-free-image/1129305852">Andrii Zastrozhnov/iStock via Getty Images Plus</a></span></figcaption></figure><p>Biomedical innovation reached a new era during the COVID-19 pandemic as drug development went into overdrive. But the ways that brand companies license their patented drugs grant them market monopoly, preventing other entities from making generics so they can exclusively profit. This significantly limits the reach of lifesaving drugs, especially to low- and middle-income countries, or LMICs. </p>
<p>I am an <a href="https://www.lucyxiaoluwang.com/">economist</a> who studies <a href="https://scholar.google.com/citations?user=M0QlVjcAAAAJ&hl=en">innovation and digitization</a> in health care markets. Growing up in a developing region in China with limited access to medications inspired my interest in institutional innovations that can facilitate drug access. One such innovation is a patent pool, or a “one-stop shop” where entities can pay one low price for permission to make and distribute all the treatments covered by the pool. My recent research found that a <a href="https://doi.org/10.1016/j.jhealeco.2022.102671">patent pool geared toward public health</a> can spur not only generic drug access in LMICs but also innovation for pharmaceutical companies.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/hGbJclE-Tw4?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Patent pools can help increase access to expensive drugs.</span></figcaption>
</figure>
<h2>Drug patents in the global landscape</h2>
<p>Patents are designed to provide incentives for innovation by granting monopoly power to patent holders for a period of time, <a href="https://www.wipo.int/patents/en/faq_patents.html">typically 20 years</a> from the application filing date. </p>
<p>However, this intention is complicated by strategic patenting. For example, companies can delay the creation of generic versions of a drug by obtaining additional patents based on slight changes to its formulation or method of use, among other tactics. This “<a href="https://doi.org/10.1016/j.jhealeco.2012.01.004">evergreens</a>” the company’s patent portfolio without requiring substantial new investments in research and development. </p>
<p>Furthermore, because patents are <a href="https://www.wipo.int/patents/en/faq_patents.html">jurisdiction-specific</a>, patent rights granted in the U.S. do not automatically apply to other countries. Firms often obtain multiple patents covering the same drug in different countries, adapting claims based on what is patentable in each jurisdiction.</p>
<p>To incentivize technology transfer to low- and middle-income countries, member nations of the World Trade Organization signed the 1995 <a href="https://www.wto.org/english/docs_e/legal_e/27-trips_01_e.htm">Agreement on Trade-Related Aspects of Intellectual Property Rights</a>, or TRIPS, which set the minimum standards for intellectual property regulation. Under TRIPS, governments and generic drug manufacturers in low- and middle-income countries may infringe on or invalidate patents to bring down patented drug prices under certain conditions. Patents in LMICs were also strengthened to incentivize firms from high-income countries to invest and trade with LMICs.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/RrN7IxvAJto?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Determining what is patentable can be complicated.</span></figcaption>
</figure>
<p>The 2001 <a href="https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm">Doha Declaration</a> clarified the scope of TRIPS, emphasizing that patent regulations should not prevent drug access during public health crises. It also allowed compulsory licensing, or the production of patented products or processes without the consent of the patent owner.</p>
<p>One notable example of national patent law in practice after TRIPS is Novartis’ anticancer drug imatinib (Glivec or Gleevec). In 2013, India’s Supreme Court <a href="https://doi.org/10.1186/1744-8603-10-3">denied Novartis’s patent application</a> for Glivec for <a href="https://www.upcounsel.com/patent-obviousness">obviousness</a>, meaning both experts or the general public could arrive at the invention themselves without requiring much skill or thought. The issue centered on whether new forms of known substances, in this case a crystalline form of imatinib, were too obvious to be patentable. At the time, Glivec had already been <a href="https://doi.org/10.1136/bmj.f2099">patented in 40 other countries</a>. As a result of India’s landmark ruling, the price of Glivec <a href="https://www.ip-watch.org/2018/05/20/five-years-indian-supreme-courts-novartis-verdict/">dropped from 150,000 INR (about US$2,200) to 6,000 INR ($88)</a> for one month of treatment.</p>
<h2>Patent challenges and pools</h2>
<p>Although TRIPS seeks to balance incentives for innovation with access to patented technologies, issues with patents still remain. Drug cocktails, for example, can contain <a href="https://doi.org/10.1038/s41587-021-01137-6">multiple patented compounds</a>, each of which can be owned by different companies. Overlapping patent rights can create a “<a href="https://doi.org/10.1086/ipe.1.25056143">patent thicket</a>” that blocks commercialization. Treatments for chronic conditions that require a stable and inexpensive supply of generics also pose a challenge, as the cost burden of long-term use of patented drugs is often unaffordable for patients in low- and middle-income countries.</p>
<p>One solution to these drug access issues is <a href="https://doi.org/10.1257/0002828041464641">patent pools</a>. In contrast to the currently decentralized licensing market, where each technology owner negotiates separately with each potential licensee, a patent pool provides a “one-stop shop” where licensees can get the rights for multiple patents at the same time. This can reduce transaction costs, royalty stacking and hold-up problems in drug commercialization. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Diagram of licensing markets with and without a patent pool" src="https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=264&fit=crop&dpr=1 600w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=264&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=264&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=332&fit=crop&dpr=1 754w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=332&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/488226/original/file-20221005-23-ac6y6n.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=332&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Patent pools create a one-stop shop for multiple patients, allowing multiple licensees to enter the market.</span>
<span class="attribution"><a class="source" href="https://doi.org/10.1016/j.jhealeco.2022.102671">Lucy Xiaolu Wang</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
</figcaption>
</figure>
<p>Patent pools were first used <a href="https://www.jstor.org/stable/43186442">in 1856 for sewing machines</a> and were once <a href="https://doi.org/10.1257/0002828041464641">ubiquitous across multiple industries</a>. Patent pools gradually disappeared after a <a href="https://supreme.justia.com/cases/federal/us/323/386/">1945 U.S. Supreme Court decision</a> that increased regulatory scrutiny, hindering the formation of new pools. Patent pools were later <a href="https://firstmonday.org/ojs/index.php/fm/article/view/1912/1794">revived in the 1990s</a> in response to licensing challenges in the information and communication technology sector.</p>
<h2>The Medicines Patent Pool</h2>
<p>Despite many challenges, the first patent pool created for the purpose of promoting public health formed in 2010 with support from the United Nations and Unitaid. The <a href="https://medicinespatentpool.org/">Medicines Patent Pool, or MPP</a>, aims to spur generic licensing for patented drugs that treat diseases disproportionately affecting low- and middle-income countries. Initially covering only HIV drugs, the MPP later expanded to include hepatitis C and tuberculosis drugs, many medications on the World Health Organization’s essential medicines list and, most recently, COVID-19 treatments and technologies.</p>
<p>But how much has the MPP improved drug access?</p>
<p>I sought to <a href="https://doi.org/10.1016/j.jhealeco.2022.102671">answer</a> <a href="https://dx.doi.org/10.2139/ssrn.4016897">this question</a> by examining how the Medicines Patent Pool has affected generic drug distribution in low- and middle-income countries and biomedical research and development in the U.S. To analyze the MPP’s influence on expanding access to generic drugs, I collected data on drug licensing contracts, procurement, public and private patents and other economic variables from over 100 low- and middle-income countries. To analyze the MPP’s influence on pharmaceutical innovation, I examined data on new clinical trials and new drug approvals over this period. This data spanned from 2000 to 2017.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Diagram of the Medicines Patent Pool licensing structure" src="https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=255&fit=crop&dpr=1 600w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=255&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=255&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=320&fit=crop&dpr=1 754w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=320&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/488228/original/file-20221005-13-vnh0dm.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=320&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The Medicines Patent Pool works as an intermediary between branded drug companies and generic licensees, increasing access to drugs.</span>
<span class="attribution"><a class="source" href="https://doi.org/10.1016/j.jhealeco.2022.102671">Lucy Xiaolu Wang</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
</figcaption>
</figure>
<p>I found that the MPP led to a 7% increase in the share of generic drugs supplied to LMICs. Increases were greater in countries where drugs are patented and in countries outside of sub-Saharan Africa, where baseline generic shares are lower and can benefit more from market-based licensing.</p>
<p>I also found that the MPP generated positive spillover effects for innovation. Firms outside the pool increased the number of trials they conducted on drug cocktails that included MPP compounds, while branded drug firms participating in the pool shifted their focus to developing new compounds. This suggests that the MPP allowed firms outside the pool to explore new and better ways to use MPP drugs, such as in new study populations or different treatment combinations, while brand name firms participating in the pool could spend more resources to develop new drugs.</p>
<p>The MPP was also able to lessen the burden of post-market surveillance for branded firms, allowing them to push new drugs through clinical trials while generic and other independent firms could monitor the safety and efficacy of approved drugs more cheaply.</p>
<p>Overall, my analysis shows the MPP effectively expanded generic access to HIV drugs in developing countries without diminishing innovation incentives. In fact, it even spurred companies to make better use of existing drugs.</p>
<h2>Technology licensing for COVID-19 and beyond</h2>
<p>Since May 2020, the Medicines Patent Pool has become a key partner of the <a href="https://www.who.int/initiatives/covid-19-technology-access-pool">World Health Organization COVID-19 Technology Access Pool</a>, which works to spur equitable and affordable access to COVID-19 health products globally. The MPP has not only made licensing for COVID-19 health products more accessible to low- and middle-income countries, but also helped establish an <a href="https://medicinespatentpool.org/covid-19/mrna-technology-transfer-hub-programme">mRNA vaccine technology transfer hub</a> in South Africa to provide the technological training needed to develop and sell products treating COVID-19 and beyond.</p>
<p>Licensing COVID-19-related technologies can be complicated by the <a href="https://pubmed.ncbi.nlm.nih.gov/34194207">large amount of trade secrets</a> involved in producing drugs derived from biological sources. These often require additional technology transfer beyond patents, such as <a href="https://heinonline.org/HOL/LandingPage?handle=hein.journals/ilr101&div=32&id=&page=">manufacturing details</a>. The MPP has also worked to communicate with brand firms, generic manufacturers and public health agencies in low- and middle-income countries to <a href="https://medicinespatentpool.org/partners/how-to-get-or-give-a-licence">close the licensing knowledge gap</a>. </p>
<p>Questions remain on how to best use licensing institutions like the MPP to increase generic drug access without hampering the incentive to innovate. But the MPP is proving that it is possible to align the interests of Big Pharma and generic manufacturers to save more lives in developing countries. In October 2022, the MPP signed a licensing agreement with Novartis for the leukemia drug <a href="https://medicinespatentpool.org/news-publications-post/mpp-signs-licence-agreement-to-increase-access-to-nilotinib-for-the-treatment-of-chronic-myeloid-leukaemia">nilotinib</a> – the first time a cancer drug has come under a public health-oriented licensing agreement.</p><img src="https://counter.theconversation.com/content/189868/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Lucy Xiaolu Wang receives research funding from Cornell University and the Institute for Humane Studies.</span></em></p>The Medicines Patent Pool was created to promote public health, facilitating generic licensing for patented drugs that treat diseases predominantly affecting low- and middle-income countries.Lucy Xiaolu Wang, Assistant Professor of Resource Economics, UMass AmherstLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1882062022-08-11T16:21:42Z2022-08-11T16:21:42ZEnduring colonialism has made it harder to end the COVID-19 pandemic<figure><img src="https://images.theconversation.com/files/478138/original/file-20220808-8055-ox4drg.jpg?ixlib=rb-1.1.0&rect=0%2C640%2C4795%2C2382&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">COVID-19 patients receive oxygen as they lie in their beds in the intensive care unit of a hospital in Machakos, Kenya, in August 2021. </span> <span class="attribution"><span class="source">(AP Photo/Brian Inganga)</span></span></figcaption></figure><iframe style="width: 100%; height: 100px; border: none; position: relative; z-index: 1;" allowtransparency="" allow="clipboard-read; clipboard-write" src="https://narrations.ad-auris.com/widget/the-conversation-canada/enduring-colonialism-has-made-it-harder-to-end-the-covid-19-pandemic" width="100%" height="400"></iframe>
<p>Rich countries are <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/who-warns-against-vaccine-hoarding-poor-countries-go-without-2021-12-09/">hoarding vaccine doses</a> while poor countries become <a href="https://english.elpais.com/usa/2021-11-29/low-vaccination-rate-in-poor-countries-creates-breeding-ground-for-coronavirus-mutations.html">breeding grounds</a> for new COVID-19 variants. </p>
<p>The World Health Organization’s <a href="https://www.who.int/initiatives/act-accelerator/covax">COVAX</a> — an abbreviation for COVID-19 Vaccines Global Access — warned that “no one is safe, until everyone is safe,” yet colonial attitudes are an obstacle to reining in the global pandemic.</p>
<p>COVID-19 has shown that global equity and inclusion are necessary to manage global crises. A major lesson from this pandemic is the need to decolonize transnational governance so that the world is better able to handle both future and current global crises and issues.</p>
<h2>COVAX’s naïve failure</h2>
<p>COVAX <a href="https://www.washingtonpost.com/world/2022/03/22/covax-problems-coronavirus-vaccines-next-pandemic/">has failed</a>.</p>
<p>It was supposed to provide vaccinations globally and equitably as well as serve as a mechanism through which both rich and poor countries would access vaccines. More than 80 per cent of the population in rich countries <a href="https://ourworldindata.org/covid-vaccinations#what-share-of-the-population-has-completed-the-initial-vaccination-protocol">is fully vaccinated</a>, compared to less than 10 per cent of the population in poor countries.</p>
<p>Credible reports say that poor countries have been affected the most by the global pandemic both in terms of <a href="https://doi.org/10.1038/d41586-022-01767-z">how deadly it has been</a>, <a href="https://www.oxfam.org/en/research/pandemic-greed">as well as economically</a>. </p>
<p>This summer, we’re seeing new pandemic waves <a href="https://www.bloomberg.com/news/articles/2022-07-16/europe-can-t-shake-covid-as-ba-5-variant-fuels-summer-wave-of-cases">in Europe</a> <a href="https://www.reuters.com/world/asia-pacific/fresh-covid-wave-sweeps-asia-nz-warns-pressure-hospitals-2022-07-14/">and Asia</a> driven by new SARS-CoV-2 variants first spotted in <a href="https://www.nature.com/articles/d41586-022-01730-y">South Africa</a>. </p>
<figure class="align-center ">
<img alt="A health-care worker in blue protective garb listens to the breathing of a woman wearing a mask and a pink shirt." src="https://images.theconversation.com/files/478135/original/file-20220808-8307-ph0zqz.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C5760%2C3837&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/478135/original/file-20220808-8307-ph0zqz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/478135/original/file-20220808-8307-ph0zqz.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/478135/original/file-20220808-8307-ph0zqz.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/478135/original/file-20220808-8307-ph0zqz.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/478135/original/file-20220808-8307-ph0zqz.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/478135/original/file-20220808-8307-ph0zqz.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A woman is screened for COVID-19 at a testing centre in Soweto, South Africa, in May 2022.</span>
<span class="attribution"><span class="source">(AP Photo/Denis Farrell)</span></span>
</figcaption>
</figure>
<p>COVAX is based on lofty ideals of equity and social justice. The initiative has <a href="https://www.healthaffairs.org/do/10.1377/forefront.20220609.695589">been necessary</a> to moderately balance the gap between rich and poor countries that would have fared worse had it not been launched. </p>
<p>But COVAX <a href="https://www.statnews.com/2021/10/08/how-covax-failed-on-its-promise-to-vaccinate-the-world/">has been called naïve</a> for relying upon the good will of rich countries for funding and on their willingness to wait patiently in line for their own populations’ doses.</p>
<p>COVAX’s good intentions have had to co-exist with “might is right” politics. Rich countries made their own deals and bought large amounts of vaccine supplies before they were even available. </p>
<p><a href="https://hbr.org/2020/05/the-danger-of-vaccine-nationalism">Vaccine nationalism</a> turned COVAX into a broker of charity. The colonial mentality believes it’s OK to cut deals with Big Pharma for vaccine doses ahead of populous poor countries, and to charitably donate to them their <a href="https://doi.org/10.1186/s12992-022-00801-z">soon-to-expire leftovers</a>.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/covid-19-vaccine-inequity-allowed-omicron-to-emerge-173361">COVID-19 vaccine inequity allowed Omicron to emerge</a>
</strong>
</em>
</p>
<hr>
<h2>Colonial mentality</h2>
<p>Global capitalism as we know it emerged from a colonial world order set up for exploitation of people and lands. European countries kidnapped people from Africa and enslaved them as they dispossessed Indigenous Peoples. This created the extractive economy of today. </p>
<p>Racial classifications and racism have remained an enduring aspect of the modern world. <a href="https://www.connectedsociologies.org/curriculum/mmw/">Colonialism produced the initial and current gap between the rich and the poor world</a>, and racialized the latter. When the <a href="https://www.britannica.com/topic/mercantilism">mercantilist order of the colonial day</a> morphed into capitalism in the 1800s, the colonial mentality that simply assumes European superiority remained.</p>
<p>This has been the basis for the colonial upper hand of the West and the United States in the type of transnational governance that emerged after the Second World War (the United Nations and <a href="https://www.brettonwoodsproject.org/2019/01/art-320747/">Bretton Woods organizations</a>, including the World Trade Organization, the International Monetary Fund and the World Bank). This has also been the basis for the colonial mentality of today. </p>
<p>COVAX was conceived during the rich <a href="https://time.com/6096172/covax-vaccines-what-went-wrong/">World Economic Forum in Davos in January 2020</a>. As news of the virus emerged from China, two professional white men <a href="https://qz.com/2071543/why-the-covax-vaccine-program-failed/">sipped whisky and envisioned COVAX in a Swiss ski resort bar.</a></p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/478134/original/file-20220808-18-zuzklf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A man with curly brown hair gestures as he speaks." src="https://images.theconversation.com/files/478134/original/file-20220808-18-zuzklf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/478134/original/file-20220808-18-zuzklf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/478134/original/file-20220808-18-zuzklf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/478134/original/file-20220808-18-zuzklf.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/478134/original/file-20220808-18-zuzklf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/478134/original/file-20220808-18-zuzklf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/478134/original/file-20220808-18-zuzklf.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Seth Berkley, CEO of the vaccine alliance Gavi, gestures as he speaks during a media interview in Switzerland in December 2021.</span>
<span class="attribution"><span class="source">(Salvatore Di Nolfi, Keystone via AP)</span></span>
</figcaption>
</figure>
<p>Seth Berkley (CEO of the <a href="https://www.gavi.org/">Global Alliance for Vaccines and Immunization, or Gavi</a>) and Richard Hatchett (CEO of <a href="https://cepi.net/">the Coalition for Epidemic Preparedness Innovations, or CEPI</a>), heads of global vaccination networks, discussed pandemic scenarios. They knew the world would need a funding and distribution strategy for shots, so they started thinking about a global solution.</p>
<p><a href="https://cepi.net/wp-content/uploads/2021/09/Proposal-to-establish-a-globally-fair-allocation-system_March-25_2020.pdf">Hatchett wrote a white paper in March 2020</a> and those ideas were the basis for the creation of COVAX in April that year. All this sounds great, but colonial mentality ultimately prevented the success of their initiative. It stopped COVAX from emerging as the co-ordinator of sorely needed 21st-century solidarity. </p>
<h2>Decolonizing crisis governance</h2>
<p>People rarely hear the names of Berkley and Hatchett in the global public sphere. Berkley’s Gavi is a global vaccine alliance that brings together the <a href="https://www.gavi.org/our-alliance">public and private sectors</a>. Hatchett’s CEPI describes itself as a “<a href="https://cepi.net/about/whoweare/">global partnership</a> between public, private, philanthropic, and civil society organizations.” </p>
<p>Today, these two global organizations — supported by the World Health Organization — are dealing with the enduring pandemic. But their <a href="https://doi.org/10.1080/17441692.2021.1987502">transparency and accountability</a> have been questionable.</p>
<p>Gavi designed COVAX without oversight and “with a small group of like-minded advisors, primarily Global North philanthropists, academics, and consultants,” according to a <a href="https://www.doctorswithoutborders.org/latest/covax-broken-promise-vaccine-equity">Doctors Without Borders report</a>. The perspectives of low- and middle-income countries, civil society organizations or regional disease control groups weren’t considered in a meaningful way. </p>
<p>At the same time, <a href="https://doi.org/10.1016/S0140-6736(21)01378-7">pharmaceutical industry</a> representatives have had a seat at the table of major decision-making discussions, and this has helped maintain the status quo of their <a href="https://doi.org/10.1038/d41586-021-01242-1">intellectual property rights</a>.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/perus-covid-19-vaccine-scandal-shows-the-shady-deals-made-with-pharma-companies-155623">Peru's COVID-19 vaccine scandal shows the shady deals made with pharma companies</a>
</strong>
</em>
</p>
<hr>
<p>The world needs to move beyond myopic national self-interest. It has become apparent that in order to control the COVID-19 pandemic, equity and inclusion are urgently required. </p>
<p>Scientists anticipate <a href="https://www.idrc.ca/en/perspectives/no-one-safe-until-everyone-safe-global-research-global-crises">there will be new pandemics along with climate change crises</a>. This will hardly be the last global public-health emergency. </p>
<p>Out of self-interest, transnational governance needs to embrace true solidarity. World leaders must use <a href="https://www.dukeupress.edu/Assets/PubMaterials/978-1-4780-0149-2_601.pdf">a decolonialized</a> imagination to face these coming global challenges.</p><img src="https://counter.theconversation.com/content/188206/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Monica Sanchez-Flores does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>A major lesson from the COVID-19 pandemic is the need to decolonize transnational governance so that the world is better able to handle both future and current global crises.Monica Sanchez-Flores, Associate Professor of Sociology, Thompson Rivers UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1863612022-07-07T21:01:59Z2022-07-07T21:01:59Z$150M is not enough: Canada’s proposed Purdue Pharma settlement for opioid damages is paltry and won’t prevent future crises<figure><img src="https://images.theconversation.com/files/472872/original/file-20220706-95-jgs9g3.jpg?ixlib=rb-1.1.0&rect=273%2C62%2C2627%2C2070&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">OxyContin, an opioid drug heavily marketed by Purdue Pharma, is associated with billions of dollars of health-care costs in Canada related to the opioid crisis.</span> <span class="attribution"><span class="source">(AP Photo/Toby Talbot)</span></span></figcaption></figure><iframe style="width: 100%; height: 100px; border: none; position: relative; z-index: 1;" allowtransparency="" allow="clipboard-read; clipboard-write" src="https://narrations.ad-auris.com/widget/the-conversation-canada/150m-is-not-enough--canada-s-proposed-purdue-pharma-settlement-for-opioid-damages-is-paltry-and-won-t-prevent-future-crises" width="100%" height="400"></iframe>
<p>On June 29, Canadian federal and provincial governments reached a proposed <a href="https://www.theglobeandmail.com/canada/article-purdue-canada-agrees-to-pay-150-million-over-opioid-harms/">$150-million settlement with Purdue Pharma Canada</a>, makers of OxyContin, an opioid-based pain medication. The settlement is intended to recover the health-care costs related to the damaging effects from the sale and marketing of OxyContin.</p>
<p>While this is the largest settlement of a governmental health-care cost claim in Canadian history, it is also a paltry amount compared to the approximately <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/sacklers-will-pay-up-6-bln-resolve-purdue-opioid-lawsuits-mediator-2022-03-03/">US$6 billion</a> that Purdue will pay in the United States. A population-equivalent Canadian settlement would have been closer to CA$900 million. </p>
<p>Until this $150-million fine, there is no record of any drug company ever having been fined for its promotion of one of its prescription drug products in Canada. Despite illegal drug promotion documented in the United States, Health Canada did not investigate whether such practices were also present in Canada. <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2622774/pdf/221.pdf">One example</a> was the distribution of 15,000 copies of a video in the U.S. claiming, without any substantiation, that opioids caused addiction in fewer than one in 100 patients.</p>
<p>When asked why, <a href="https://www.thestar.com/news/canada/2014/06/26/dangers_of_offlabel_drug_use_kept_secret.html">agency officials responded</a> that Health Canada “has not been made aware of any specific similar issue in Canada and has not received complaints.” </p>
<p>Equally concerning, however, is the intense focus on financial settlements at the expense of regulatory changes.</p>
<h2>Regulatory loopholes</h2>
<p>Since the opioid crisis emerged, researchers and journalists have identified a range of strategies and policy loopholes that companies took advantage of to push their products. These included: </p>
<ul>
<li><p><a href="https://doi.org/10.2105%2FAJPH.2007.131714">industry influence over clinical practice guidelines</a>, which are <a href="https://www.ncbi.nlm.nih.gov/books/NBK390308/">recommendations for patient care</a>, </p></li>
<li><p><a href="http://dx.doi.org/10.1136/medethics-2013-101343">funding that can bias medical education</a>, </p></li>
<li><p>providing health-care professionals with <a href="https://doi.org/10.1016/j.amjmed.2017.12.045">free trips to exotic locations in order to listen to “expert opinions,”</a></p></li>
<li><p>insufficient transparency around <a href="https://www.motherjones.com/crime-justice/2019/08/unsealed-documents-show-how-purdue-pharma-created-a-pain-movement/">funding of non-profit organizations</a> and </p></li>
<li><p>a government-sanctioned culture of <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3999539/">self-regulation, enabling the pharmaceutical industry to regulate its own promotion practices</a>. </p></li>
</ul>
<p>Despite this knowledge, virtually all of these strategies remain entirely legal.</p>
<h2>Funding transparency</h2>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/472876/original/file-20220706-26-il0pw1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Protesters with signs and a skeleton made of pill bottles outside a building" src="https://images.theconversation.com/files/472876/original/file-20220706-26-il0pw1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/472876/original/file-20220706-26-il0pw1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=426&fit=crop&dpr=1 600w, https://images.theconversation.com/files/472876/original/file-20220706-26-il0pw1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=426&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/472876/original/file-20220706-26-il0pw1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=426&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/472876/original/file-20220706-26-il0pw1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=535&fit=crop&dpr=1 754w, https://images.theconversation.com/files/472876/original/file-20220706-26-il0pw1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=535&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/472876/original/file-20220706-26-il0pw1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=535&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Protesters outside a Boston, Mass. courthouse in 2019, during a lawsuit against Purdue Pharma over its role in the national drug epidemic. The company’s U.S. settlements for OxyContin lawsuits total about US$6 billion.</span>
<span class="attribution"><span class="source">(AP Photo/Charles Krupa)</span></span>
</figcaption>
</figure>
<p>Transparency around pharmaceutical funding of health-care professionals and non-profit organizations remains virtually non-existent in Canada. The United States passed the <a href="https://www.healthaffairs.org/do/10.1377/hpb20141002.272302/full/">Physician Payments Sunshine Act</a> in 2010 requiring transparency of financial relationships between physicians and the health-care industry. Yet no such system of transparency exists in Canada. </p>
<p>In fact, the federal government has <a href="https://www.cbc.ca/news/health/pharmaceutical-drug-company-doctor-physician-payment-disclosure-transparency-1.4169888">explicitly rejected setting up a similar mechanism</a>. The one attempt to do so in Ontario was <a href="https://doi.org/10.1503/cmaj.109-5718">terminated in 2018</a> when Doug Ford’s Progressive Conservatives took office. Such a system would have significantly increased transparency around the types of physician payments that directly influenced opioid prescription patterns. </p>
<h2>Funding medical education</h2>
<p>Pharmaceutical companies are <a href="https://www.thestar.com/news/investigations/2019/02/11/family-doctors-can-no-longer-claim-ritzy-drug-dinners-as-professional-training.html"><em>still</em> permitted</a> to fund groups putting on accredited medical education events for Canadian doctors. This is despite <a href="https://doi.org/10.1371/journal.pmed.1000352">significant evidence</a> that industry funding leads to a bias in prescriptions and few improvements in prescribing. </p>
<p><a href="https://nationalpost.com/news/canada/the-selling-of-oxycontin">This type of funded “medical education”</a> was one of the main avenues through which Purdue Pharma and other companies managed to convince health-care professionals of the benefits of their products, while minimizing the products’ overall risk of addiction. </p>
<p>There is little evidence that removing industry funding would create an information gap, and it is <a href="https://doi.org/10.1371/journal.pmed.1000352">likely to drastically reduce overall industry influence over the profession</a>. Yet the federal government has often done little to use such practices to ensure appropriate drug prescribing and use, putting it at odds with governments in many other <a href="https://www.nps.org.au">wealthy industrialized countries</a>.</p>
<h2>Product monographs</h2>
<figure class="align-center ">
<img alt="White pills scattered on a black background" src="https://images.theconversation.com/files/472878/original/file-20220706-9520-6h9cs9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/472878/original/file-20220706-9520-6h9cs9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=431&fit=crop&dpr=1 600w, https://images.theconversation.com/files/472878/original/file-20220706-9520-6h9cs9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=431&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/472878/original/file-20220706-9520-6h9cs9.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=431&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/472878/original/file-20220706-9520-6h9cs9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=541&fit=crop&dpr=1 754w, https://images.theconversation.com/files/472878/original/file-20220706-9520-6h9cs9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=541&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/472878/original/file-20220706-9520-6h9cs9.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=541&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Since the opioid crisis emerged, researchers and journalists have identified a range of strategies and policy loopholes that companies took advantage of to push their products.</span>
<span class="attribution"><span class="source">(AP Photo/Keith Srakocic)</span></span>
</figcaption>
</figure>
<p>Canadian regulators have revealed little about how they plan to reduce industry influence over product monographs, which provide detailed information for doctors about specific drugs. </p>
<p><a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/product-monograph/frequently-asked-questions-product-monographs-posted-health-canada-website.html">Health Canada states</a> that a product monograph should be a “factual, scientific document on a drug product … devoid of promotional material.” </p>
<p>Despite this, Oxycontin’s original Canadian product monograph in 1996 recommended increased use of the product in cases of “<a href="https://www.gov.nl.ca/hcs/files/publications-oxycontin-final-report.pdf">breakthrough pain</a>,” a term that had previously appeared in Oxycontin advertisements. Moreover, the product monograph <a href="https://doi.org/10.1111/add.14929">provided no recommended maximum dose</a>, meaning there was no upper dose threshold for OxyContin when it was marketed. </p>
<p>Despite this, there has been no formal inquiry into how this scientific document could be so significantly affected by industry interests, or how to prevent similar influence from recurring.</p>
<h2>Gifts to health-care professionals</h2>
<p>The pharmaceutical industry continues to provide non-research-related transfers to health-care professionals. These transfers include gifts of food and drink, all-expenses paid travel to conferences and marketing-related consultancies. Again, <a href="https://nationalpost.com/news/canada/the-selling-of-oxycontin">this form of funding was repeatedly used by opioid manufacturers</a> to influence health-care professionals, with companies even flying them out to exotic locations to listen to “key opinion leaders” speak on the benefits of Oxycontin and other opioids.</p>
<p>Despite virtually no rationale for the “educational” value of these events, such financial transfers continue today. In 2020, 10 of the 47 drug company members of Innovative Medicines Canada, the organization that represents the pharmaceutical industry, <a href="https://www.doi.org/10.12927/hcpol.2022.26729">spent over $28 million on fees and travel for health-care providers</a>.</p>
<p>The settlement with Purdue Pharma Canada is <a href="https://www.cbc.ca/news/canada/british-columbia/purdue-bankruptcy-filings-provinces-68b-us-opioid-crisis-oxycontin-1.5799580">frustratingly small in comparison to the billions in health-care costs of the opioid crisis</a>. But it also shouldn’t distract from the bigger issue: despite the many lessons learned from the crisis, there have been very few regulatory changes made in Canada since. </p>
<p>Unless something radically changes in how the pharmaceutical industry is regulated, there is little reason to assume a similar crisis won’t occur again.</p><img src="https://counter.theconversation.com/content/186361/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Daniel Eisenkraft Klein receives funding from a Social Sciences and Research Council Doctoral Fellowship and through internal grants from Johns Hopkins University's Opioid Industry Documents Archive. He is presently a part-time Policy Analyst in the Tobacco Control Directorate at Health Canada. </span></em></p><p class="fine-print"><em><span>In 2019-2021, Joel Lexchin received payments for writing a brief on the role of promotion in generating prescriptions for Goodmans LLP and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p>The Purdue Pharma settlement is paltry compared to costs of the opioid crisis. Without major changes to pharma industry regulation, there is little reason to think a similar crisis won’t occur again.Daniel Eisenkraft Klein, PhD Candidate, Dalla Lana School of Public Health, University of TorontoJoel Lexchin, Professor Emeritus of Health Policy and Management, York University, CanadaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1812352022-06-05T12:22:00Z2022-06-05T12:22:00ZWe still need a vaccine patent waiver, but not the one on offer at the World Trade Organization meeting<figure><img src="https://images.theconversation.com/files/466910/original/file-20220603-17-5nwz4k.jpg?ixlib=rb-1.1.0&rect=382%2C238%2C4930%2C3241&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Global Justice campaigners in London stand by fake coffins to highlight global COVID-19 deaths. If pharma companies waived intellectual property rights, it would be easier for low- and middle-income countries to access COVID-19 vaccines.
</span> <span class="attribution"><span class="source">(AP Photo/Alastair Grant)</span></span></figcaption></figure><p>In mid-June, the <a href="https://www.wto.org/english/thewto_e/minist_e/mc12_e/mc12_e.htm">World Trade Organization (WTO) will meet</a> to finish negotiations to waive certain sections of the agreement on Trade Related Intellectual Property Rights (TRIPS). However, it is not the TRIPS waiver originally proposed 18 months ago by member states South Africa and India, which would have allowed countries to produce lower-cost generic vaccines and other COVID-19 medical tools without the risk of legal trade challenges.</p>
<p>The opposition to the waiver from a few WTO member states — home to the pharma companies holding monopoly patent rights over the vaccines — has resulted in “<a href="https://doi.org/10.1016/S0140-6736(22)00328-2">vaccine apartheid</a>” (rich countries buying up all the early supplies) and “<a href="https://www.thenation.com/article/economy/pfizer-pandemic-profiteering/">vaccine profiteering</a>” (companies making multi-billion-dollar profits and fighting every effort to allow generic competition). </p>
<p>Vaccine supply is no longer the main issue. Pharma companies still holding the vaccine patents can now produce enough for everyone — though not necessarily at affordable prices — and have described the <a href="https://healthpolicy-watch.news/with-covid-vaccine-supply-outstripping-vaccination-rates-pharma-giants-question-pursuit-of-ip-waiver/">idea of a TRIPS waiver now as “insane” and “unproductive</a>.” </p>
<p>But for the scores of WTO member states and thousands of global health researchers still supporting the waiver <a href="https://theconversation.com/covid-19-drug-and-vaccine-patents-are-putting-profit-before-people-149270">(myself included)</a>, getting the WTO to approve one at its upcoming June ministerial meeting remains important. Just not the waiver that’s on the negotiating table. </p>
<h2>Worse than no waiver</h2>
<p><a href="https://www.wto.org/english/news_e/news22_e/trip_06may22_e.htm">The current version</a> is the outcome of discussions involving the two original proposing members, the United States and the European Union. It is restricted to vaccines — a U.S. request — ignoring, for now at least, therapeutics, diagnostics and other essential COVID-19-related health products. </p>
<figure class="align-center ">
<img alt="Hands holding a syringe and vial of vaccine" src="https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">The waiver under negotiation puts a time limit on the waived obligations.</span>
<span class="attribution"><span class="source">(AP Photo/Michel Euler)</span></span>
</figcaption>
</figure>
<p>It requires generic manufacturers to identify all related patents, which is impossible given vaccines’ complex “<a href="https://doi.org/10.1007/s10551-021-04873-6">patent thickets</a>” (overlapping patent rights), and something not required under present TRIPS rules. It puts a time limit on the waived obligations, as though pandemics are calendar-savvy. </p>
<p>While it removes barriers to generic companies exporting to developing countries that lack their own manufacturing capacity, it excludes countries that supplied more than 10 per cent of global vaccine exports in 2021, namely, China. </p>
<p>A shadow of its original intent, the new waiver is <a href="https://twn.my/title2/wto.info/2022/ti220514.htm">endorsed only by the EU, with support from the WTO director-general</a>. </p>
<h2>Why the new waiver proposal should be opposed</h2>
<p>If enacted as currently drafted, the new waiver sets a precedent that will restrict the ability of countries with the capacity to mass produce therapeutics, diagnostics and even personal protective equipment. This would apply to the still-with-us COVID-19 pandemic and for any new zoonotic outbreaks that are <a href="https://theconversation.com/future-infectious-diseases-recent-history-shows-we-can-never-again-be-complacent-about-pathogens-177746">almost certainly on the near horizon</a>. </p>
<p>Without a meaningful waiver, new variant-ready vaccines <a href="https://medicalxpress.com/news/2022-04-pfizer-eyes-covid-vaccine-variants.html">expected later this year</a> are likely to be gobbled up once more by high-paying rich countries, with the poorer ones left with older less-effective versions. </p>
<figure class="align-center ">
<img alt="Vials of vaccine with purple caps shot from above" src="https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Pharma companies holding patents can now produce enough vaccine for everyone, though not necessarily at affordable prices.</span>
<span class="attribution"><span class="source">(AP Photo/Achmad Ibrahim)</span></span>
</figcaption>
</figure>
<p>The same scenario applies to therapeutics such as <a href="https://www.bloomberg.com/news/articles/2022-04-22/covid-antiviral-pills-seen-surging-after-slow-initial-uptake">Pfizer’s antiviral drug, Paxlovid</a>. Most of its current supply will go to wealthy countries that can afford the high prices Pfizer charges. Pfizer will allow licences for generic versions to be produced for distribution to 95 developing countries, but not until 2023. </p>
<p>Moderna, the other mRNA vaccine leader, is busy <a href="https://www.aljazeera.com/opinions/2022/3/16/modernas-profits-show-why-big-pharma-cant-meet-our-health-needs">registering patents for its vaccine in South Africa</a> as that country, with WTO support, is close to copying Moderna’s recipe, the know-how for which it plans to share publicly. Moderna’s new patents could <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-patent-application-raises-fears-africa-covid-vaccine-hub-2022-02-17/">jeopardize this effort</a>. The company meanwhile has plans to create its own mRNA plant in Kenya to supply the African continent <a href="https://socialeurope.eu/control-the-vampire-companies">on its own profitable terms</a>. </p>
<p>On May 25, Pfizer announced that it would eventually provide all “<a href="https://www.weforum.org/agenda/2022/05/pfizer-launches-an-accord-for-a-healthier-world-a-call-for-action-to-improve-health-equity-globally/?utm_source=sfmc&utm_medium=email&utm_campaign=2778051_Am22-AgendaDaily-26May2022&utm_term=&emailType=Agenda%20Week">current and future patent-protected medicines on a not-for-profit basis” to 45 lower-income countries</a>, beginning with five countries in Africa. </p>
<p>The company’s decision is welcome, but questions remain. Will Pfizer forego lucrative sales of its current and future drugs to rich countries in order to supply (eventually) the 1.2 billion people living in the world’s poorest nations? Or will these countries have to wait until the paying world’s 6.7 billion people have had their supply needs met? </p>
<h2>Current property rights not fit for global health purpose</h2>
<p>The bottom line: for-profit companies should not be setting public health policy during global health emergencies. Individual corporate decisions to supply life-saving health innovations at cost in otherwise unprofitable markets is not a sustainable or ethical solution. </p>
<p>Bluntly stated: companies’ intellectual property rights should not be allowed to trump people’s health rights. </p>
<figure class="align-center ">
<img alt="A crowd outdoors with people holding blue signs reading 'Support patent waivers on COVID-19 vaccines'" src="https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=417&fit=crop&dpr=1 600w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=417&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=417&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=524&fit=crop&dpr=1 754w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=524&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=524&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Activists support patent waivers on COVID-19 vaccines in front of the European Union office during an EU summit in Kyiv, Ukraine, on Oct. 12, 2021.</span>
<span class="attribution"><span class="source">(AP Photo/Efrem Lukatsky)</span></span>
</figcaption>
</figure>
<p>Investment into new health products means taking risks, and it warrants some reward. However, much of the groundwork in pharmaceutical research is publicly funded. </p>
<p>This was certainly the case with COVID-19 vaccines, and one of the reasons why many organizations argued that these discoveries <a href="https://peoplesvaccine.org/">should be considered “people’s vaccines” and treated as public goods</a>. Governments need to place <a href="https://www.who.int/publications/m/item/governing-health-innovation-for-the-common-good">conditions on the financial support they give to health research</a> to ensure that the results are more equitably shared. </p>
<p>In the case of public health emergencies, such as pandemics, this should include requirements that companies forego their monopoly property rights, accept negotiated royalties for their efforts and share their knowledge. </p>
<p>President Joe Biden’s administration recently took a step in this direction. It <a href="https://www.hhs.gov/about/news/2022/05/12/nih-licenses-covid-19-research-tools-early-stage-technologies-who-program.html">licensed 11 COVID-19 inventions</a> that arose from in-house research at the National Institutes of Health, including early-stage development of the stabilized spike protein that forms the base of mRNA vaccines. </p>
<p>Described as “<a href="https://www.science.org/content/article/pretty-big-deal-u-s-makes-covid-19-technologies-available-use-developing-countries">a pretty big deal</a>” by an advocate of shared intellectual property, the licenses will be administered by the non-profit <a href="https://medicinespatentpool.org/">Medicines Patent Pool</a> that negotiates low royalty costs for generic manufacturers, so inventors will still get some reward. </p>
<p>But this early-stage knowledge-sharing is insufficient to enable full development of medical innovations, which requires drug companies holding patents on the finished, commercialized vaccines and COVID-19-related technologies to waive these rights and to share their technical know-how. </p>
<h2>Canada and the June WTO meeting</h2>
<p>As with the rest of the world, Canada’s attention is moving away from COVID-19 to <a href="https://www.cbc.ca/news/business/canada-inflation-april-1.6457520">inflation fears</a> and <a href="https://theconversation.com/why-did-russia-invade-ukraine-faqs-about-the-conflict-that-has-shocked-the-world-177963">Russia’s war against Ukraine</a>. With surprisingly little media coverage, the government began holding <a href="https://www.ourcommons.ca/Committees/en/FAAE/StudyActivity?studyActivityId=11504514">parliamentary committee hearings on vaccine equity</a> this past spring. Still, it remains uncommitted on the waiver, as it has since the original waiver was proposed. </p>
<figure class="align-center ">
<img alt="A globe and a syringe against a blue background" src="https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&rect=748%2C30%2C3341%2C2501&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=398&fit=crop&dpr=1 600w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=398&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=398&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=501&fit=crop&dpr=1 754w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=501&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=501&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Companies’ intellectual property rights should not be allowed to trump people’s health rights.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Health and civil society groups, meanwhile, remain committed to urging the government to make the right ethical and health protective decision. They are calling on Canada to <a href="https://policyalternatives.ca/newsroom/updates/canada-should-reject-compromise-proposal-trips-waiver-its-present-form-civil">use the June WTO meeting to bring the deeply flawed new waiver proposal closer to the original one</a>. </p>
<p>There is still a need for a decent TRIPS waiver to ensure that intellectual property rights do not get in the way of rapid and equitable access to medicines or any other essential health innovations. That must be one of the key lessons we take from our COVID-19 experience.</p><img src="https://counter.theconversation.com/content/181235/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ronald Labonte receives funding from the Canadian Institutes of Health Research, and is a member of the Steering Council of the People's Health Movement, which advocates for global health equity.</span></em></p>Waiving patent rights on COVID-19 vaccines and drugs is still crucial to ensure access globally, but the waiver on the table at the June World Trade Organization meeting doesn’t do the job.Ronald Labonte, Professor and Distinguished Research Chair, Globalization and Health Equity, L’Université d’Ottawa/University of OttawaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1821472022-05-15T20:15:16Z2022-05-15T20:15:16ZAustralia risks relying on Pfizer and Moderna for its COVID vaccines. 3 ways to break free<figure><img src="https://images.theconversation.com/files/460499/original/file-20220429-26-ut9yfa.jpg?ixlib=rb-1.1.0&rect=14%2C0%2C3180%2C1992&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-vector/coronavirus-vaccine-affordability-people-want-buy-1908778336">Shutterstock</a></span></figcaption></figure><p>The rapid development and deployment of COVID vaccines has been one of the greatest achievements of the pandemic.</p>
<p>However, Australia <a href="https://www.mja.com.au/journal/2022/217/2/covid-19-vaccines-boosters-and-mandates-building-mission-economy-not-rentier">risks relying on</a> COVID vaccines from two main companies – Pfizer and Moderna – and that’s a problem.</p>
<p>While the need for COVID vaccines is not going away anytime soon, we need to shape the market to drive more competition for better access to improved vaccines.</p>
<p>Here’s what Australia needs to do to break free from an effective duopoly dominating the local market, especially when many of us are likely to <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/getting-your-vaccination/booster-doses">need boosters</a>.</p>
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Read more:
<a href="https://theconversation.com/covid-vaccination-recommendations-evolve-over-time-who-is-due-for-which-dose-now-181779">COVID vaccination recommendations evolve over time. Who is due for which dose now?</a>
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<h2>How did we get here?</h2>
<p>When COVID finally broke out at scale in Australia late last year, the vaccines (and high levels of adult vaccination) worked extremely well to reduce deaths and severe illness.</p>
<p>Since January 1 this year, there have been <a href="https://ourworldindata.org/coronavirus/country/australia">more than</a> 5.9 million confirmed COVID infections nationwide, but about 5,300 deaths.</p>
<p>Yet current vaccines aren’t 100% effective at protecting against infection; new viral variants (<a href="https://theconversation.com/why-are-there-so-many-new-omicron-sub-variants-like-ba-4-and-ba-5-will-i-be-reinfected-is-the-virus-mutating-faster-182274">and sub-variants</a>) continue to emerge; protection via <a href="https://www1.racgp.org.au/newsgp/clinical/booster-protection-wanes-after-four-months-what-do">vaccination</a> and <a href="https://theconversation.com/how-long-does-protective-immunity-against-covid-19-last-after-infection-or-vaccination-two-immunologists-explain-177309">prior infection wanes</a> quite quickly, meaning reinfection is becoming more common and booster shots may remain part of the landscape for some time to come.</p>
<p>Meanwhile, <a href="https://www.sciencedirect.com/science/article/pii/S0140673622003282?via%3Dihub">vaccine inequity</a> remains an unresolved problem. This has led to a situation where rich countries, such as Australia, are giving booster shots where some <a href="https://www.sciencedirect.com/science/article/pii/S0140673622008170?via%3Dihub">poorer countries</a> don’t even have enough vaccine for first doses.</p>
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Read more:
<a href="https://theconversation.com/how-australias-fickleness-on-covid-vaccines-is-perpetuating-global-vaccine-inequity-165001">How Australia's fickleness on COVID vaccines is perpetuating global vaccine inequity</a>
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<h2>Pfizer and Moderna, but not much else</h2>
<p>In <a href="https://www.mja.com.au/journal/2022/217/2/covid-19-vaccines-boosters-and-mandates-building-mission-economy-not-rentier">a recent article</a> in the Medical Journal of Australia, we outline the need to break free from the handful of powerful players still dominating Australia’s COVID vaccine market.</p>
<p>While the number of <a href="https://covid19.trackvaccines.org/agency/who/">approved COVID vaccines</a> <a href="https://en.wikipedia.org/wiki/List_of_COVID-19_vaccine_authorizations">is growing</a> around the world, Australia largely still relies on only two, namely vaccines from Pfizer and Moderna.</p>
<p>The AstraZeneca and Novavax vaccines are only rarely <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/advice-for-providers/clinical-guidance/clinical-recommendations">used as boosters</a> if <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/approved-vaccines/novavax">no other vaccines</a> are suitable.</p>
<p>More than <a href="https://www.health.gov.au/sites/default/files/documents/2022/05/covid-19-vaccine-rollout-update-11-may-2022.pdf">95% of Australian adults</a> have received two doses of COVID vaccine already. So future requirements are primarily for boosters and child vaccines. Australia, therefore, continues to face an effective duopoly.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Middle-aged lady smiling with bandaid on upper arm" src="https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/462361/original/file-20220511-22-9sko2m.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Future supplies of COVID vaccines will be used for booster shots and children.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/portrait-mature-female-smiling-after-getting-1927590569">Shutterstock</a></span>
</figcaption>
</figure>
<h2>The power of patents</h2>
<p>This effective duopoly further reinforces the already considerable power these manufacturers hold via the intellectual property rights to their vaccines.</p>
<p>These vaccine patents are protected by the World Trade Organization under the Agreement on Trade-Related Aspects of Intellectual Property Rights (or <a href="https://www.wto.org/english/tratop_e/trips_e/trips_e.htm">TRIPS</a>). This prevents international competitors from replicating patented technologies. </p>
<p>These patent rights allow companies to earn higher profits (or “economic rents”) than if their technologies were freely available to allow open competition.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1523962841178558469"}"></div></p>
<p>The intellectual property dimensions of COVID vaccines have been controversial. </p>
<p>Pfizer and Moderna have continued <a href="https://peoplesvaccine.org/resources/media-releases/pharma-companies-make-1000-dollars-per-second/">to make extraordinary profits</a> from COVID vaccines.</p>
<p>Yet Moderna found itself <a href="https://www.ipwatchdog.com/2022/03/31/nihs-fight-ownership-modernas-covid-19-patent-highlights-hazards-business-collaborations/id=148040/">in dispute</a> with the United States government, conceding <a href="https://www.nytimes.com/2021/12/17/us/moderna-patent-nih.html?msclkid=2baf60f6d0f511ec9526396a701fee1f">US government employees</a> had directly developed several technologies key to the Moderna vaccine (not to mention years of publicly-funded basic research). </p>
<p>Moderna has also <a href="https://www.npr.org/sections/goatsandsoda/2021/10/19/1047411856/the-great-vaccine-bake-off-has-begun">resisted sharing</a> the formulation of its vaccine to allow key middle-income countries to manufacture it.</p>
<p>Meanwhile, Pfizer has negotiated <a href="https://www.citizen.org/article/pfizers-power/?eType=EmailBlastContent&eId=9b708ddb-d34d-4dfa-95e4-d4d672a82a1b">advantageous</a> and <a href="https://www.theguardian.com/uk-news/2021/dec/05/wall-of-secrecy-in-pfizer-contracts-as-company-accused-of-profiteering">secretive</a> vaccine contracts with governments, shifting liability and risk onto governments and controlling nations’ ability to redistribute stock between themselves. </p>
<p>High-income countries have <a href="http://aftinet.org.au/cms/Civil-society-organisations-urge-Australia-to-oppose-ineffective-TRIPS-proposal">consistently resisted</a> or watered down <a href="https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W688.pdf&Open=True">calls for a TRIPS waiver</a>, which would have allowed global sharing of manufacturing technologies. </p>
<p><a href="https://journals.plos.org/globalpublichealth/article?id=10.1371%2Fjournal.pgph.0000427">Critics argue</a> the opponents of a TRIPS waiver are largely concerned about avoiding setting any precedents that might allow the profits of Big Pharma to be limited in future.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/why-a-leaked-wto-solution-for-a-covid-patent-waiver-is-unworkable-and-wont-make-enough-difference-for-developing-countries-179642">Why a leaked WTO 'solution' for a COVID patent waiver is unworkable and won't make enough difference for developing countries</a>
</strong>
</em>
</p>
<hr>
<h2>What should Australia do next?</h2>
<p>In Australia, the reality that current COVID vaccines only partially prevent transmission leaves us dependent on this effective duopoly for ongoing boosters. Boosters also remain mandated for people in <a href="https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/information-for-aged-care-providers-workers-and-residents-about-covid-19-vaccines/residential-aged-care-workers">many occupations</a>.</p>
<p>Australia can escape this captive vaccine market in three steps.</p>
<p><strong>1. Approve more vaccines</strong></p>
<p>Australia needs to expand the supply of new COVID vaccines by actively assisting a wider range of manufacturers to bring their products to the Therapeutic Goods Administration for approval. This would increase competition for boosters and stimulate the development and supply of more effective “sterilising” vaccines (ones that prevent viral transmission).</p>
<p>Meanwhile, Australia must extract maximum value from all existing vaccine contracts, and insist upon full freedom to transfer supplies to our regional neighbours.</p>
<p><strong>2. Push for patent reform</strong></p>
<p>Australia should use its influence to vigorously drive a TRIPS waiver at the World Trade Organization. It should also explore strategic options with a coalition of partners to consider how the current global intellectual property regime could be rapidly reformed or, if necessary, circumvented. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/3-ways-to-vaccinate-the-world-and-make-sure-everyone-benefits-rich-and-poor-155943">3 ways to vaccinate the world and make sure everyone benefits, rich and poor</a>
</strong>
</em>
</p>
<hr>
<p><strong>3. Set up domestic, not-for-profit capability</strong></p>
<p>Australia should institute an economic “mission” to establish publicly-owned, not-for-profit vaccine and essential pharmaceuticals research, development and manufacturing infrastructure and capability in Australia. This would serve domestic and wider regional needs for COVID and beyond. </p>
<p>Sadly, the Australian government’s recent agreement with Moderna for the company to establish <a href="https://theconversation.com/new-facility-to-be-built-in-victoria-to-produce-mrna-vaccines-173674">mRNA manufacturing here</a> is <em>not</em> such an example. It may risk entrenching existing power. The agreement is also <a href="https://www.abc.net.au/radionational/programs/sciencefriction/moderna-mrna-australia-covid-pharmaceutical-profits-business/13849344">still secret</a>. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/new-facility-to-be-built-in-victoria-to-produce-mrna-vaccines-173674">New facility to be built in Victoria to produce mRNA vaccines</a>
</strong>
</em>
</p>
<hr>
<p>In an increasingly insecure world of growing disruptions – ecological and health crises, fracturing supply chains and heightened military tensions – Australia can provide a safe and resilient vaccine and pharmaceutical manufacturing capability to protect the health of Australians and our neighbours. </p>
<p>However, old models that privilege shareholders, via excess profits and intellectual property protection, will not deliver this new vision.</p>
<hr>
<p><em><a href="https://www.deakin.edu.au/about-deakin/people/sithara-wanni-arachchige-dona2">Sithara Dona</a>, an associate research fellow at Deakin University, co-authored the research mentioned in this article.</em></p><img src="https://counter.theconversation.com/content/182147/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Martin Hensher has received an honorarium from Novartis SA (Brazil) for a lecture delivered to the Novartis Access 2021 conference. He is a member of the South Australian Health Performance Council and a board member of Glenview Community Services, Tasmania (a not-for-profit aged care provider).</span></em></p>Boosters and vaccinating children mean we’re relying on two pharmaceutical companies to supply Australia’s COVID vaccines. That needs to change.Martin Hensher, Henry Baldwin Professorial Research Fellow in Health System Sustainability, University of TasmaniaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1748742022-04-06T12:24:13Z2022-04-06T12:24:13ZRepurposing generic drugs can reduce time and cost to develop new treatments – but low profitability remains a barrier<figure><img src="https://images.theconversation.com/files/455834/original/file-20220401-30230-ka75fr.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C1998%2C1488&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">From thalidomide to Viagra, drug repurposing salvaged failed treatments by giving them new targets.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/pills-jars-royalty-free-illustration/676746260">smartboy10/DigitalVision Vectors via Getty Images</a></span></figcaption></figure><p>Discovering new ways to use existing drugs can come about intentionally or by chance. </p>
<p>Sometimes physicians or patients notice an unanticipated beneficial effect from a drug. One example is <a href="https://dx.doi.org/10.1038%2Fnrd2030">sildenafil</a>, a drug originally developed to treat severe chest pain from coronary artery disease. While sildenafil failed clinical trials, researchers noticed that one of its side effects was induced erections. This led to its successful rebranding as the erectile dysfunction drug Viagra.</p>
<p>Most of the time when drugs are repurposed for diseases or conditions they were not originally intended for, it’s done deliberately. As scientists raced to develop treatments for COVID-19, drug repurposing came into the spotlight for reasons <a href="https://www.scientificamerican.com/article/common-antidepressant-slashes-risk-of-covid-death/">good</a> and <a href="https://www.nytimes.com/2022/03/30/health/covid-ivermectin-hospitalization.html">bad</a>. </p>
<p>As a <a href="https://scholar.google.com/citations?user=O4qsjycAAAAJ&hl=en">researcher focused on drug discovery and development</a>, I have seen the potential of repurposing and the challenges it faces. While finding new uses for drugs that have already been tested for safety and approved by the FDA can substantially <a href="https://doi.org/10.1038/534314a">reduce the time and cost</a> of development, financial and logistical barriers can make it difficult to get to market.</p>
<h2>The success of thalidomide</h2>
<p>When repurposing is successful, a drug that is ineffective or harmful for one condition can be lifesaving for others. </p>
<p>One such drug is <a href="https://dx.doi.org/10.1177%2F2040620711413165">thalidomide</a>, first approved as a morning sickness treatment. It gained notoriety in the late 1950s when it caused birth defects in an estimated 10,000 infants worldwide, resulting in <a href="https://www.medicalnewstoday.com/articles/how-the-thalidomide-scandal-led-to-safer-drugs">changes in drug regulation and development</a> that included increased developmental toxicity testing. Thalidomide was globally banned by the end of the 1960s.</p>
<p>In the 1990s, however, researchers discovered that thalidomide <a href="https://dx.doi.org/10.1073%2Fpnas.91.9.4082">inhibits angiogenesis</a>, or the growth of new blood vessels that deliver nutrients and oxygen to tumors. Its new use as a treatment for a blood cancer called <a href="https://dx.doi.org/10.1177%2F2040620711413165">multiple myeloma</a> ultimately saw clinical and commercial success. This led to the development of <a href="https://dx.doi.org/10.1177%2F2040620711413165">improved versions</a> of the drug that treat cancer with reduced side effects.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/5olSLe4faiw?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Repurposing generic drugs could offer a cheaper and faster way to develop new treatments.</span></figcaption>
</figure>
<p>Scientists have continued to find other therapeutic uses for thalidomide. </p>
<p>When researchers discovered that thalidomide <a href="https://dx.doi.org/10.1016%2Fj.chembiol.2015.05.009">targets a molecule in the body</a> that marks other proteins for destruction, they leveraged this function into an emerging technology called <a href="https://doi.org/10.1038/s41392-019-0101-6">PROTACs</a>. Many drugs work in the body by inhibiting a particular target that produces an unwanted effect, typically in a way that is reversible and temporary. PROTACs, on the other hand, are a type of drug that can destroy the target altogether. This potentially increases the effectiveness of the drug and reduces the chance of drug resistance.</p>
<p>An example is <a href="https://clinicaltrials.gov/ct2/show/NCT03888612">bavdegalutamide</a>, a PROTAC that combines thalidomide with an inhibitor typically used to treat prostate cancer. This inhibitor works by blocking a target that supplies the tumor with hormones that help it grow. An ongoing phase 2 clinical trial on bavdegalutamide hinges on the idea that destroying the target would cut off hormone supply to tumors and stop their growth more effectively than conventional inhibitors.</p>
<p>Researchers are currently churning out PROTACS often by repurposing existing drugs. With ongoing promising results, 2021 saw the launch of a <a href="https://doi.org/10.1038/d41573-021-00052-4">flurry of clinical trials</a> testing PROTACs as a treatment for a number of different cancers.</p>
<h2>Repurposing for COVID-19</h2>
<p>Reearchers have used a myriad of drug repurposing approaches <a href="https://doi.org/10.1016/j.patter.2020.100090">during the COVID-19 pandemic</a>, ranging from educated guesses to large-scale drug screening and data mining from millions of electronic health records. Irrespective of how researchers decide which drugs to repurpose, all candidates must demonstrate strong clinical benefit in people before they can be authorized or approved for a new proposed use by the FDA.</p>
<p>My research team and I tested 1,425 FDA-approved drugs in human cells infected with COVID-19 and found <a href="https://doi.org/10.1073/pnas.2105815118">17 repurposing candidates</a> for further examination. Several of the leads we identified have since entered preliminary clinical trials, including drugs originally intended to treat <a href="https://clinicaltrials.gov/ct2/show/NCT04465695">leprosy</a> and <a href="https://doi.org/10.1101/2021.06.22.21259318">prostate cancer</a>, as well as a <a href="https://doi.org/10.3390/medicina57080842">supplement derived from milk</a>.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Illustration of pill capsules falling into pill bottle." src="https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=826&fit=crop&dpr=1 600w, https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=826&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=826&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1038&fit=crop&dpr=1 754w, https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1038&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/455845/original/file-20220401-23422-jsu15t.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1038&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Drug repurposing could help expand treatment options for various diseases, including COVID-19.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/pills-and-capsule-jar-royalty-free-illustration/676742914">smartboy10/DigitalVision Vectors via Getty Images</a></span>
</figcaption>
</figure>
<p>Researchers initiated <a href="https://dx.doi.org/10.3389%2Ffphar.2021.704205">hundreds of clinical studies</a> early in the pandemic to test drug repurposing candidates for COVID-19. There have been a few notable successes including the generic antidepressant <a href="https://dx.doi.org/10.1016%2FS2214-109X(21)00448-4">fluvoxamine</a>, which reduced the risk of hospitalization by 32% in one clinical study. One <a href="https://doi.org/10.1080/07853890.2022.2034936">meta-analysis</a> on fluvoxamine and two other <a href="https://theconversation.com/could-oral-antiviral-pills-be-a-game-changer-for-covid-19-an-infectious-disease-physician-explains-why-these-options-are-badly-needed-169919">antiviral COVID-19 drugs</a>, molnupiravir and Paxlovid, found that they all offered protective benefits against COVID-19 with comparable safety profiles.</p>
<p>Unlike these new COVID-19 antivirals, however, fluvoxamine has a <a href="https://doi.org/10.1176/appi.books.9781615371624.as13">40-year track record</a> of safely treating depression and obsessive-compulsive disorder. Despite this, fluvoxamine has not been authorized for emergency use by the FDA, and the National Institutes of Health states that there is <a href="https://www.covid19treatmentguidelines.nih.gov/therapies/immunomodulators/fluvoxamine/">insufficient evidence</a> for its use against COVID-19.</p>
<h2>Drug discovery challenges</h2>
<p>Successful drug repurposing highlights the difficulty of predicting off-target effects of new treatments. </p>
<p>Eflornithine, for example, is a drug found to be ineffective against cancer – but it does turn out to inhibit <a href="https://doi.org/10.1111/j.1365-4632.2006.03079.x">facial hair growth</a> in women and cure a parasitic infection called <a href="https://doi.org/10.1016/s0140-6736(87)91131-7">trypanosomiasis</a>, or sleeping sickness. It’s often not immediately obvious why one drug would effectively treat two seemingly different health issues like these.</p>
<p>There are approximately 2,500 FDA-approved drugs, and an average of 46 new drugs are <a href="https://doi.org/10.1038/d41573-021-00002-0">approved each year</a>. However, <a href="https://doi.org/10.1038/nrd.2016.136">over 90%</a> of drugs that enter clinical trials fail. This increases to <a href="http://dx.doi.org/10.1126/scitranslmed.aaw8412">97% for cancer drugs</a>. While many shots on goal are required to produce a viable drug, each failed drug is a candidate for repurposing. Researchers like me have been collecting these “failed” compounds for further testing, trawling through research papers, patents and clinical trial databases to find repurposing candidates. Some labs have used <a href="https://doi.org/10.1016/S2589-7500(20)30192-8">artificial intelligence</a> to automate this process. </p>
<p>But it can be difficult to ascertain what drugs are available to repurpose. While one drug development database proposes that there are <a href="https://www.gostardb.com/about">47,000 previously tested compounds</a> ready for repurposing, there is <a href="https://doi.org/10.1093/bib/bbaa003">no central repository</a> for this information.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Illustration of various pills falling into an open hand" src="https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=793&fit=crop&dpr=1 600w, https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=793&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=793&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=997&fit=crop&dpr=1 754w, https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=997&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/455846/original/file-20220401-23379-gm7g5b.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=997&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Parsing through the thousands of drugs for repurposing candidates can be difficult without knowing all the available options.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/illustration/catching-pills-royalty-free-illustration/676747518">smartboy10/DigitalVision Vectors via Getty Images</a></span>
</figcaption>
</figure>
<h2>Commercialization landscape</h2>
<p>Drug repurposing faces an <a href="https://doi.org/10.1126/scitranslmed.3009120">intellectual property barrier</a>. Repurposing is most accessible with <a href="https://doi.org/10.1186/s40545-020-00282-8">generic drugs</a> that don’t have patents restricting their use for other conditions. But there is <a href="https://doi.org/10.1186/s40545-020-00282-8">less opportunity for profit</a> with generics than with new drugs.</p>
<p>Patents allow drug suppliers to have a monopoly over sales for a span of time. Repurposed drugs are typically granted “<a href="https://doi.org/10.1126/scitranslmed.3009120">use patents</a>” that protect the use of an existing drug for a new particular disease. But companies consider this type of protection less valuable than a “composition of matter” patent that restricts drug sales just to patent owners. An <a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/generic-competition-and-drug-prices">FDA analysis</a> found a drug with two drug suppliers resulted in an average 39% price reduction, and six or more suppliers resulted in a 95% reduction. With less patent protection on a drug, more competitors can enter the market and manufacturers make less money.</p>
<p>Because of this perceived lack of commercial potential, drug repurposing is typically left to academic institutions that don’t have the resources to get either new or retooled drugs through the <a href="https://doi.org/10.1001/jama.2020.1166">costly approval process</a>.</p>
<p>It’s possible that if fluvoxamine were a new drug in development with patent protection within a Big Pharma company, it might have already gained FDA approval to treat COVID-19. But as it stands, fluvoxamine is a widely available generic that any doctor can prescribe “<a href="https://theconversation.com/off-label-use-is-common-in-medicine-a-bioethicist-and-legal-philosopher-explain-why-the-covid-19-vaccines-are-different-171007">off-label</a>” to treat conditions that have not been approved by the FDA, like COVID-19. </p>
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<p>This leads to a <a href="https://globalforum.diaglobal.org/issue/june-2020/repurposing-challenges-conceptualization-of-a-research-agenda/">tragedy of the commons</a> whereby no company will invest in the clinical trials needed to bring a repurposed drug to the marketplace because the resulting benefits would be immediately shared with all competitors.</p>
<p>Bringing a new drug to market is a <a href="https://doi.org/10.1038/d41573-021-00190-9">lengthy</a> and <a href="https://doi.org/10.1001/jama.2020.1166">costly</a> process with a <a href="https://doi.org/10.1038/nrd.2016.136">high failure rate</a>. When the pharmaceutical industry can’t justify developing a new drug because of a low return on investment, drug repurposing can fill the gap. <a href="https://covid19.nih.gov/news-and-stories/repurposing-drugs-to-save-time-and-lives">Federal support</a> could make repurposing more appealing from a business standpoint, giving companies the incentive to enter the marketplace and boost this cost-effective way to address unmet medical needs.</p><img src="https://counter.theconversation.com/content/174874/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jonathan Sexton receives funding from the National Institutes of Health. </span></em></p>Drug repurposing can redeem failed treatments and squeeze out new uses from others. But many pharmaceutical companies are hesitant to retool existing drugs without a high return on investment.Jonathan Sexton, Assistant Professor of Internal Medicine and Medicinal Chemistry, University of MichiganLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1749672022-01-24T16:03:16Z2022-01-24T16:03:16ZLower drug prices are a priority for Canadians, but not for the federal government<figure><img src="https://images.theconversation.com/files/441912/original/file-20220121-8679-1cfzhwc.jpg?ixlib=rb-1.1.0&rect=58%2C100%2C5330%2C3631&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Changes to the Patented Medicine Prices Review Board regulations, which are intended to help lower drug costs in Canada, were originally scheduled to take effect in July 2020.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><iframe style="width: 100%; height: 175px; border: none; position: relative; z-index: 1;" allowtransparency="" src="https://narrations.ad-auris.com/widget/the-conversation-canada/lower-drug-prices-are-a-priority-for-canadians--but-not-for-the-federal-government" width="100%" height="400"></iframe>
<p>Once again, the federal minister of health has postponed <a href="https://www.canada.ca/en/health-canada/news/2021/12/statement-from-the-minister-of-health-on-the-deferral-of-coming-into-force-of-the-regulations-amending-the-patented-medicines-regulations.html">changes to the Patented Medicine Prices Review Board (PMPRB) regulations</a> for another six months until July 1, 2022. </p>
<p>The excuse is that bringing the amendments into force during the COVID-19 pandemic requires preparedness and consultation and the government needs to further engage stakeholders — the pharmaceutical industry and its allies.</p>
<p>The process of changing the regulations started in June 2016 when the PMPRB released a <a href="http://www.pmprb-cepmb.gc.ca/CMFiles/Consultations/DiscussionPaper/PMPRB_DiscussionPaper_June2016_E.pdf">public discussion paper</a>. Changes were necessary because of the high cost of drugs in Canada: The PMPRB reported in 2019 that only the <a href="https://www.canada.ca/content/dam/pmprb-cepmb/documents/reports-and-studies/annual-report/2019/pmprb-ar-2019-en.pdf">United States, Switzerland and Germany had higher drug prices</a>. On a per capita basis, <a href="https://www.oecd-ilibrary.org/docserver/ae3016b9-en.pdf?expires=1640634504&id=id&accname=guest&checksum=BB9D07F986EF2A8A219322378B5291C5">Canada spent the third-highest amount in the world</a> on drugs in 2021, according to the Organization for Economic Co-operation and Development. </p>
<p>Lowering drug prices was part of the <a href="https://www.budget.gc.ca/2019/docs/themes/pharmacare-assurance-medicaments-en.html">groundwork for a national pharmacare plan</a> — although pharmacare gets only a passing mention in the <a href="https://pm.gc.ca/en/mandate-letters/2021/12/16/minister-health-mandate-letter">latest mandate letter</a> from Prime Minister Justin Trudeau to the new Health Minister Jean-Yves Duclos.</p>
<p>Finally, the multinational drug companies were not living up to their end of the bargain: in 1987 they agreed to spend 10 per cent of sales revenue on research and development in Canada in return for Canada changing its rules about drug patents. By 2019, that figure had <a href="https://www.canada.ca/content/dam/pmprb-cepmb/documents/reports-and-studies/annual-report/2019/pmprb-ar-2019-en.pdf">shrunk to 3.9 per cent</a>.</p>
<h2>Delayed by two years</h2>
<p>The PMPRB changes were initially supposed to come into effect on July 1, 2020, but were delayed for six months. The reasons, <a href="https://www.pharmainbrief.com/2020/06/pmprb-update-amendments-delayed-new-guidelines-consultation-announced-and-judicial-review-heard/">according to the federal government</a>, were “to minimize the imposition of new administrative burden on industry” and to give stakeholders more time to provide feedback because of the impact of the pandemic. </p>
<figure class="align-center ">
<img alt="A medicine bottle tipped on its side, with white caplets arranged in the shape of a dollar sign" src="https://images.theconversation.com/files/441926/original/file-20220121-17-x9agmc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/441926/original/file-20220121-17-x9agmc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=333&fit=crop&dpr=1 600w, https://images.theconversation.com/files/441926/original/file-20220121-17-x9agmc.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=333&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/441926/original/file-20220121-17-x9agmc.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=333&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/441926/original/file-20220121-17-x9agmc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=419&fit=crop&dpr=1 754w, https://images.theconversation.com/files/441926/original/file-20220121-17-x9agmc.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=419&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/441926/original/file-20220121-17-x9agmc.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=419&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Efforts to lower drug prices were part of the groundwork for a national pharmacare plan.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Fast forward six months and there’s another six-month delay. This time, a <a href="https://www.ctvnews.ca/health/health-canada-delays-drug-pricing-reforms-citing-covid-19-challenges-for-manufacturers-1.5258523">spokesperson for Health Canada</a> said that the industry needed more time to adjust to new reporting requirements while dealing with the challenges posed by the COVID-19 pandemic. </p>
<p>On June 24, 2021, seven days before the changes were to start, the federal government decided that industry needed even more time because of the pandemic. On that occasion, Health Canada said, “<a href="https://www.theglobeandmail.com/politics/article-ottawa-delays-drug-pricing-changes-a-third-time-citing-covid-19/">It is not anticipated that further delaying these amendments will be needed</a>.” But as the <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/canada-delay-drug-price-reforms-by-six-months-cites-pandemic-2021-12-23/">announcement on Dec. 23</a> showed, another delay was necessary.</p>
<h2>Lobbying efforts</h2>
<p>Are the pandemic and the need for more discussions the only reasons for these repeated delays? The multinational drug companies, as represented by their lobby group Innovative Medicines Canada (IMC), have been very vocal in their opposition to the changes. </p>
<figure class="align-right ">
<img alt="Innovation, Science and Industry Minister Francois-Philippe Champagne standing with a finger raised in the House of Commons" src="https://images.theconversation.com/files/441922/original/file-20220121-23-vilfiz.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/441922/original/file-20220121-23-vilfiz.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=420&fit=crop&dpr=1 600w, https://images.theconversation.com/files/441922/original/file-20220121-23-vilfiz.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=420&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/441922/original/file-20220121-23-vilfiz.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=420&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/441922/original/file-20220121-23-vilfiz.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=528&fit=crop&dpr=1 754w, https://images.theconversation.com/files/441922/original/file-20220121-23-vilfiz.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=528&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/441922/original/file-20220121-23-vilfiz.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=528&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Innovation, Science and Industry Minister François-Philippe Champagne is reportedly rebuilding bridges with Big Pharma.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Patrick Doyle</span></span>
</figcaption>
</figure>
<p><a href="http://innovativemedicines.ca/wp-content/uploads/2018/02/20180212_IMC_CG1_Submission_Regulations_Amending_the_Patented_Medicines_Regulations_Final.pdf">IMC disputed the need for them</a>, the benefits that would result and claimed that drug companies would either not launch or delay the launch of new drugs in Canada. The only evidence for the latter threat was a <a href="https://lifesciencesontario.ca/wp-content/uploads/2020/06/EN_LSO_Global-Launch-Benchmarking_Webinar-June22-20_Final.pdf">report from Life Sciences Ontario</a>, an organization whose membership includes multiple multinational drug companies.</p>
<p>If the pandemic meant more discussions were necessary, it also meant more lobbying by the industry. According to an investigative article in <a href="https://breachmedia.ca/how-canada-became-a-vaccine-villain/"><em>The Breach</em></a>, an online media outlet, IMC lobbied elected representatives and government officials 55 times in 2021. </p>
<blockquote>
<p>“Lobbyists for U.S.-based pharmaceutical giants Pfizer and Johnson & Johnson … paid designated office holders in Canada a combined 116 visits since October 2020.” </p>
</blockquote>
<p>The bulk of the lobbying was to make sure that Canada <a href="http://innovativemedicines.ca/innovative-medicines-canada-cautions-covid-19-trips-ip-waiver/">didn’t support any relaxation of patent standards at the World Trade Organization</a>. But <a href="https://www.theglobeandmail.com/opinion/article-in-battle-between-trudeau-and-big-pharma-over-drug-prices-federal/">in light of reports</a> that then Innovation Minister François-Philippe Champagne had “made it a mission to rebuild bridges with Big Pharma,” <a href="https://lobbycanada.gc.ca/app/secure/ocl/lrs/do/clntSmmrySrch?dpohFullName=FRANCOIS+PHILIPPE+CHAMPAGNE&searchType=Search">some of that lobbying</a> was very likely also around the PMPRB changes. </p>
<p>Besides lobbying and predicting repercussions like delayed drug launches, the industry has also attempted to buy its way out of the changes. IMC offered to <a href="https://www.reuters.com/article/canada-pharmaceuticals-idUSKBN27V0LO">spend $1 billion</a> over 10 years to boost local manufacturing and commercialization, and on new programs to improve access to drugs for rare diseases on the condition that some of the pricing changes be scrapped.</p>
<h2>Vocal opposition</h2>
<p>IMC was <a href="https://www.theglobeandmail.com/business/article-health-canada-delays-drug-pricing-reforms-citing-covid-19-challenges/">backed up by various patient groups</a>. Durhan Wong-Reiger, president and CEO of the Canadian Organization for Rare Disorders (CORD), warned that “draconian” restrictions on drug prices won’t solve Canada’s budget problems. </p>
<p>Chris MacLeod, the founder of the Cystic Fibrosis Treatment Society, said burdensome drug-pricing measures could cut Canada out of the latest COVID-19 vaccines and treatments being developed around the world. </p>
<figure class="align-center ">
<img alt="Shelves of prescription medication at a pharmacy" src="https://images.theconversation.com/files/441925/original/file-20220121-23-1quc7tf.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/441925/original/file-20220121-23-1quc7tf.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=395&fit=crop&dpr=1 600w, https://images.theconversation.com/files/441925/original/file-20220121-23-1quc7tf.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=395&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/441925/original/file-20220121-23-1quc7tf.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=395&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/441925/original/file-20220121-23-1quc7tf.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=496&fit=crop&dpr=1 754w, https://images.theconversation.com/files/441925/original/file-20220121-23-1quc7tf.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=496&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/441925/original/file-20220121-23-1quc7tf.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=496&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Canadians pay some of the highest prescription drug costs in the world.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Ryan Remiorz</span></span>
</figcaption>
</figure>
<p>On its website, <a href="https://www.raredisorders.ca/cord-membership/partners/">CORD lists over 25 drug companies</a> among its “corporate leaders.” The <a href="https://cfadvocacynow.com/">website of the Cystic Fibrosis Treatment Society</a> doesn’t say if it has any relationships with drug companies.</p>
<p>Likewise, a group of “concerned Canadian doctors” recently wrote an opinion piece in the <a href="https://www.thespec.com/opinion/contributors/2021/12/22/press-pause-on-drug-price-policy.html"><em>Hamilton Spectator</em></a>. In it they argued that the federal government should halt implementation of new federal drug pricing regulations until a thorough consultation that includes physicians is undertaken. </p>
<p>Their reasoning is that if the regulations went ahead, Canadians will have increasing difficulty accessing effective new drugs. The article did not mention whether any of the signatories had financial conflicts of interest with drug companies.</p>
<p>Finally, there has been pressure from outside Canada. The <a href="https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/PhRMA_2021-Special-301_Review_Comment-1.pdf">Pharmaceutical Research and Manufacturers of America</a>, the lobby group that represents giant American drug companies, made it clear that in its view the changes “will significantly undermine the marketplace for innovative pharmaceutical products, delay or prevent the introduction of new medicines in Canada and reduce investments in Canada’s life sciences sector.” </p>
<p>In its annual report, the <a href="https://ustr.gov/sites/default/files/files/reports/2021/2021%20Special%20301%20Report%20(final).pdf">Office of the United States Trade Representative</a> warned that the U.S. “will continue to monitor the implementation and effects of … changes to the Patented Medicine Prices Review Board’s pricing regulations.”</p>
<h2>Rising drug costs for Canadians</h2>
<p>While the federal government has been bowing to the pharmaceutical industry, the amount that Canadians spend on medicines has continued to rise. In 2020, Canadians <a href="https://canjhealthtechnol.ca/index.php/cjht/article/view/mt0001">spent an estimated $32.7 billion</a>, 4.3 per cent more than the previous year. Meanwhile, <a href="https://angusreid.org/pharmacare-2020/">more than two-in-five Canadians are concerned about their ability to afford prescription drugs in 10 years</a>. </p>
<p>A <a href="https://nursesunions.ca/wp-content/uploads/2018/05/2018.04-Body-Count-Final-web.pdf">report from the Canadian Federation of Nurses Unions</a> estimates that the lack of affordability of prescription drugs could be causing 370 to 640 premature deaths due to heart disease every year, and 270 to 420 premature deaths annually of working-age Canadians with diabetes. </p>
<figure class="align-center ">
<img alt="Pharmacist's hands using a pill tray to count green and yellow capsules, with a pill bottle and prescriptions in the background." src="https://images.theconversation.com/files/441923/original/file-20220121-23-og491k.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/441923/original/file-20220121-23-og491k.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=481&fit=crop&dpr=1 600w, https://images.theconversation.com/files/441923/original/file-20220121-23-og491k.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=481&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/441923/original/file-20220121-23-og491k.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=481&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/441923/original/file-20220121-23-og491k.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=605&fit=crop&dpr=1 754w, https://images.theconversation.com/files/441923/original/file-20220121-23-og491k.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=605&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/441923/original/file-20220121-23-og491k.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=605&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">More than two-in-five Canadians are concerned about their ability to afford prescription drugs in 10 years.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Ryan Remiorz</span></span>
</figcaption>
</figure>
<p>Added to these grim numbers, job losses due to the pandemic have meant the loss of benefits including insurance for prescription drugs. An <a href="https://angusreid.org/pharmacare-2020/">Angus Reid poll</a> reports while seven per cent of Canadians gained prescription drug coverage during the year ending in October 2020, 14 per cent lost it during the same year.</p>
<p>Canadians have been waiting more than five years for lower drug prices. It’s time to stop waiting.</p><img src="https://counter.theconversation.com/content/174967/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2019-2021, Joel Lexchin received payments for writing a brief on the role of promotion in generating prescriptions for Goodmans LLP and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p>Changes to Canada’s Patented Medicine Prices Review Board regulations have been postponed for a fourth time in two years as Canadians continue to pay some of the highest drug prices in the world.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, Emergency Physician at University Health Network, Associate Professor of Family and Community Medicine, University of TorontoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1740872021-12-22T16:58:22Z2021-12-22T16:58:22ZGeneric drug names provide information for doctors, so why is Health Canada promoting the use of pharma brand names?<figure><img src="https://images.theconversation.com/files/438724/original/file-20211221-49721-1iiafqu.jpg?ixlib=rb-1.1.0&rect=143%2C53%2C5838%2C3260&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Generic drug names are assigned at the global level by the World Health Organization in conjunction with national naming authorities.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><iframe style="width: 100%; height: 175px; border: none; position: relative; z-index: 1;" allowtransparency="" src="https://narrations.ad-auris.com/widget/the-conversation-canada/generic-drug-names-provide-information-for-doctors--so-why-is-health-canada-promoting-the-use-of-pharma-brand-names" width="100%" height="400"></iframe>
<p>Brand names are widely used when we want to refer to a specific product — an Apple computer, a Tesla car. Sometimes brand names are so widely used that they take over — we ask for a Kleenex instead of a tissue.</p>
<p>Drugs have two names. The brand name is the one that’s chosen by the company making it and that company is the only one allowed to use the name. (The name that the company proposes is <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/frequently-asked-questions-guidance-document-industry-review-drug-brand-names.html">reviewed by Health Canada</a>.) Brand names are almost always short and catchy so that doctors will remember them. </p>
<p>Generic names are assigned at the global level by the <a href="https://www.ismp.org/resources/are-national-efforts-reduce-drug-name-confusion-paying">World Health Organization in conjunction with national naming authorities</a>. These names are often long, but part of the reason for the length is that they tell doctors about the pharmacologic property and/or chemical structure of the medication.</p>
<p>The generic name for the new <a href="https://www.npr.org/sections/health-shots/2019/05/24/725404168/at-2-125-million-new-gene-therapy-is-the-most-expensive-drug-ever">US$2-million-per-patient drug for spinal muscular atrophy</a> is onasemnogene abeparvovec. The brand name is Zolgensma. Which one are doctors (and patients) going to remember and use? The answer is obvious. </p>
<p>One of the <a href="https://dx.doi.org/10.1503%2Fcmaj.112160">associate editors at the Canadian Medical Association Journal</a> makes the point that “some brand names are created to be reassuring or promising — so-called ‘benefit-led’ names such as Paxil, Celebrex and Gluconorm — when they actually need to be prescribed with great care and consideration of the drug’s potential effects on the individual patient.”</p>
<figure class="align-center ">
<img alt="Prescription bottles and white tablets on a white background" src="https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Some pharmaceutical brand names are meant to sound reassuring or promising.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Is the use of brand names the right way to talk about prescription drugs? Apparently, Health Canada thinks so. Want information about safety problems with a medicine? On Canada’s recall site, you’ll see the <a href="https://recalls-rappels.canada.ca/en/search/site?search_api_fulltext=Daclizumab">brand name in CAPITALS</a> and the generic name in lower case and in brackets. </p>
<p>Want to see if there is a shortage of the drug that your doctor just wrote you a prescription for? Go to <a href="https://www.drugshortagescanada.ca/">Drug Shortages Canada</a> and you’ll find the brand names of the drugs, again in capitals. </p>
<p>If you’re interested in why Health Canada approved a particular drug, the <a href="https://hpr-rps.hres.ca/reg-content/summary-basis-decision-result.php?lang=en&term=">Summary Basis of Approval document</a> will help you understand. But once more the brand name is the most prominent one, and again it’s in capitals.</p>
<h2>What’s in a name?</h2>
<p>In medical school, students are taught to use generic names. <a href="http://www.icmje.org/recommendations/browse/manuscript-preparation/preparing-for-submission.html">Medical journals</a> tell authors to use generic names in the articles that they write. Does it matter which name doctors use? The answer is yes.</p>
<p>When <a href="https://doi.org/10.1177/0310057x0903700401">Australian anaesthetists and doctors training to be anaesthetists in two teaching hospitals</a> were given the brand names of drugs, they could only correctly identify the therapeutic group that the drug came from in just over half the cases. Without knowing what therapeutic group the drug came from, doctors could accidentally have used another drug from the same group or they could have used the drug incorrectly.</p>
<figure class="align-right ">
<img alt="Illustration of a pharma rep shaking hands with a doctor" src="https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=754&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Seeing drug company sales representatives more frequently is associated with more brand name prescribing, which translates into more expensive prescribing. Sales reps also usually leave out important safety information.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>The <a href="https://dx.doi.org/10.1002%2Fpds.4224">more money that doctors receive from drug companies</a> in the form of meals, travel arrangements and ownership royalties, the less likely they were to prescribe by generic name. Seeing <a href="https://www.cmu.edu/news/stories/archives/2017/may/marketing-and-prescribing-behavior.html">drug company sales representatives more frequently</a> is associated with more brand name prescribing, which translates into more expensive prescribing. Sales reps also usually <a href="https://doi.org/10.1007/s11606-013-2411-7">leave out important safety information</a> about drugs they are promoting, so besides prescriptions costing more, they might also be more likely to harm patients.</p>
<p>Brand names, drug regulation (the domain of Health Canada) and pharmaceutical promotion have come together in a particularly egregious way in the case of buprenorphine-naloxone, brand name Suboxone — an opioid medication used to treat opioid addiction. </p>
<p>Even though generic formulations of the drug have been available in Canada since 2013 (and even earlier in the United States), the drug is widely referred to by its brand name, including <a href="https://www.theglobeandmail.com/canada/article-the-timmins-tag-team-when-opioids-and-official-inaction-were-killing/">in the media</a>, <a href="https://news.ontario.ca/en/backgrounder/47406/taking-action-to-prevent-opioid-addiction-and-overdose">by policy makers</a> and by doctors. </p>
<h2>Branded education</h2>
<p>One way this happened was through the promotion of an “educational” program developed and delivered by Indivior, the company that holds the rights to Suboxone. In some provinces, completing this branded program is <a href="https://crism.ca/wp-content/uploads/2018/03/CRISM_NationalGuideline_OUD-ENG.pdf">a pre-requisite to being able to prescribe buprenorphine-naloxone</a>. The same strategy has been executed for a related injectable form of buprenorphine, also owned by Indivior. </p>
<p>This use of the branded program is the case even though there are perfectly <a href="https://www.camh.ca/en/education/continuing-education-programs-and-courses/continuing-education-directory/opioid-use-disorder-treatment-course">good, accredited, non-industry educational programs</a> already available to teach appropriate opioid addiction care and prescribing to doctors, nurses and pharmacists. </p>
<p>The inclusion of the brand name in the title of this program flies in the face of <a href="https://policybase.cma.ca/documents/PolicyPDF/PD21-20.pdf">recommended practices</a> and <a href="https://www.cfpc.ca/CFPC/media/PDF/Understanding-Mainpro-Certification-English-April15-2021.pdf">accreditation standards</a> for Canadian medical education programs.</p>
<p>Yet, the branded program is fully sanctioned by Health Canada through that body’s review and approval of the <a href="https://pdf.hres.ca/dpd_pm/00063411.PDF">Suboxone product monograph</a>. This document, which describes the nature of the drug and its approved uses in Canada, includes a description of the requirement for participation in the branded “training program.” </p>
<p><a href="http://doi.org/10.1056/NEJMp1906680">As has been documented in the U.S.</a>, Indivior and its parent company Reckitt Benckiser have engaged in a variety of unscrupulous practices to promote their multibillion-dollar buprenorphine product line — ultimately paying <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/indivior-solutions-sentenced-part-2-billion-resolution-false-safety-claims-concerning-suboxone">some of the largest fines in U.S. pharmaceutical history</a>. In this light, a branded “educational” program seems to be one more vehicle for brand name promotion, and one in which Health Canada is directly complicit.</p>
<p>When doctors use brand names they may be less knowledgeable about the drugs they are prescribing, their prescriptions cost more and patients may be more likely to suffer side-effects. When Health Canada prioritizes brand names over generic names it is actively contributing to all these problems.</p>
<p>Health Canada should know better and must do better.</p><img src="https://counter.theconversation.com/content/174087/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2018-2021, Joel Lexchin received payments for writing a brief in an action for side effects of a drug for Michael F. Smith, Lawyer and a second brief on the role of promotion in generating prescriptions for Goodmans LLP and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p><p class="fine-print"><em><span>Abhimanyu Sud has received funding from or consulted with the Canadian Institutes of Health Research, Health Canada, Association of Faculties of Medicine of Canada, University of Toronto, Centre for Effective Practice, and Mississauga-Halton Local Health Integration Network for research and medical education relating to opioid use and drug policy.</span></em></p>Generic drug names are often long, but they can tell doctors what type of medicine it is and how it works. But it’s brand names that appear first and most prominently in Health Canada materials.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, Emergency Physician at University Health Network, Associate Professor of Family and Community Medicine, University of TorontoAbhimanyu Sud, Assistant Professor, Department of Family and Community Medicine, University of TorontoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1728352021-11-30T22:03:02Z2021-11-30T22:03:02ZDrug companies protest when Health Canada withdraws their products for safety reasons<figure><img src="https://images.theconversation.com/files/434537/original/file-20211129-23-3yrz9a.jpg?ixlib=rb-1.1.0&rect=2%2C31%2C1914%2C1244&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The level of evidence for withdrawing a drug does not appear to affect the pharma company's response.</span> <span class="attribution"><span class="source">(Pixabay)</span></span></figcaption></figure><p>For decades oil companies denied that their products were <a href="https://www.theguardian.com/environment/2021/mar/18/oil-industry-fossil-fuels-air-pollution-documents">harmful to human health</a>. <a href="https://theintercept.com/2021/06/30/epa-pesticides-exposure-opp/">Pesticide companies</a> did the same with their products. We all know how executives from <a href="https://truthinitiative.org/research-resources/tobacco-prevention-efforts/5-ways-tobacco-companies-lied-about-dangers-smoking">cigarette companies lied about the harms from smoking</a>.</p>
<p>Are drug companies any different? When drugs are taken off the market because they are either unsafe or don’t work, do companies admit that there are problems? There is certainly some evidence that companies deny the evidence.</p>
<p>Researchers in the United States <a href="https://doi.org/10.1056/NEJMoa072761">published a meta-analysis</a> in the <em>New England Journal of Medicine</em> (<em>NEJM</em>) in 2007 showing an association between the diabetes drug rosiglitazone and a significant increase in the risk of a heart attack. The <a href="https://www.natap.org/2007/HIV/052107_03.htm">response from GlaxoSmithKline</a>, the maker of the drug, was that the company “strongly disagrees with the conclusions reached in the <em>NEJM</em> article, which are based on incomplete evidence and a methodology that the author admits has significant limitations.” </p>
<p>In another case, a 2001 <a href="https://doi.org/10.1001/jama.286.8.954">article in <em>JAMA: The Journal of the American Medical Association</em></a> raised “a cautionary flag about the risk of cardiovascular events with COX-2 inhibitors,” a type of non-steroidal anti-inflammatory drug used to treat pain and inflammation. Merck was the company selling one of these drugs and an <a href="https://doi.org/10.1001/jama.286.22.2808">employee of Merck Research Laboratories and a Merck consultant</a> claimed that “the analysis provides no substantial support for their conclusion.”</p>
<p>But these might have been isolated examples. In a <a href="https://doi.org/10.3233/JRS-210013">recently published article</a>, I set out to answer the question in a systematic manner.</p>
<h2>Withdrawn drugs</h2>
<p>As a first step, I compiled a list of all the drugs that Health Canada had pulled from the shelves since 1990 either because they had serious safety problems or because they didn’t work. Putting that list together was not easy because of the way that Health Canada organizes information. I had to go through thousands of safety notices and warnings since 2000 on <a href="https://recalls-rappels.canada.ca/en/search/site?f%5B0%5D=audience%3A216&f%5B1%5D=category%3A180">Health Canada’s website</a>, and then combined what I found with the information in an <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4085091/">article that I published in 2014</a>. </p>
<p>In the end, I had the names of 31 drugs. Then I looked for either press releases from the companies about those drugs or articles containing direct quotations or paraphrases of company statements, and found material about 22 drugs.</p>
<p>Almost half the time (10 of 22 drugs), the companies disagreed with the decision to withdraw the drug from the market, and in just under one-third (seven of 22 cases) they agreed with the decision. In the other five cases they felt that the drug could have been kept on the market with restrictions or said that they might reintroduce the drug.</p>
<figure class="align-center ">
<img alt="Exterior shot of office building housing Bayer Healthcare's North American headquarters in Whippany, N.J." src="https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Bayer had no objections when Health Canada withdrew the company’s cholesterol drug from the market in 2001.</span>
<span class="attribution"><span class="source">(AP Photo/Julio Cortez)</span></span>
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</figure>
<p>Here’s what <a href="https://www.thestar.com/news/2007/10/04/health_canada_pulls_arthritis_drug_prexige.html">Novartis said about</a> its anti-inflammatory drug Prexige, which was linked to cardiac deaths: “We’re disappointed with Health Canada’s decision. We don’t agree with the assessment of the data.” </p>
<p>A <a href="https://www.thestreet.com/investing/stocks/bristol-myers-quits-on-antidepressant-10161474">Bristol-Myers spokesman</a> said the company “still believes that prescribing physicians believe Serzone has a role to play in the treatment of depression.” Serzone was associated with liver damage.</p>
<p>On the other hand, a minority of companies had no objections to the action taken by Health Canada. <a href="https://www.cmaj.ca/content/cmaj/165/5/632.1.full.pdf">Bayer’s Canadian general manager</a> said in an interview in 2001 about the withdrawal of a cholesterol drug, “We have taken the responsible route based on increased reports of side effects.”</p>
<p>The strength of the evidence that leads to decisions that a drug is too unsafe to be left on the market can vary significantly, but that didn’t seem to affect what companies had to say. In the three cases with the strongest evidence for a withdrawal, companies agreed with the withdrawal only once.</p>
<p>It does appear that companies have recently become less defensive about their drugs. Up until 2009, they objected to Health Canada’s decision nine out of 14 times, whereas since then they have agreed in five out of eight cases.</p>
<h2>The need for transparency</h2>
<p>There are many, non-exclusive reasons why a company might defend its drug: a commercial motivation to see the drug brought back onto the market; defending the corporate image and integrity; a different scientific interpretation about the nature of the evidence used to withdraw the drug from the market; and an agreement about the safety problem but a different assessment about the overall benefit-to-harm ratio of the drug.</p>
<figure class="align-center ">
<img alt="Pills arranged in the shape of a question mark against a yellow background" src="https://images.theconversation.com/files/434545/original/file-20211129-27-1ka2m2h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/434545/original/file-20211129-27-1ka2m2h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/434545/original/file-20211129-27-1ka2m2h.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/434545/original/file-20211129-27-1ka2m2h.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/434545/original/file-20211129-27-1ka2m2h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/434545/original/file-20211129-27-1ka2m2h.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/434545/original/file-20211129-27-1ka2m2h.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Health Canada should be completely transparent about how it evaluates safety information and makes safety decisions.</span>
<span class="attribution"><span class="source">(Pexels/Anna Shvets)</span></span>
</figcaption>
</figure>
<p>Finally, does it really matter if companies object? After all, the drug is still no longer being sold. </p>
<p>The answer is yes. It’s important for the public to have confidence in the rigour of regulators’ decisions. For example, documents released by the U.S. Food and Drug Association (FDA) showed that drug company <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/204042Orig1s026.pdf">Janssen engaged in “extensive” efforts with the FDA</a> over the wording of a safety warning about the risk of lower limb amputation associated with the use of canaglifloxin, a drug used in the treatment of diabetes. Due to the redaction of large sections of the document, it is not possible to know how extensive the changes were. </p>
<p>Health Canada typically <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-document-industry-issuance-health-professional-communications-public-communications-market-authorization-holders-health-canada-2010.html">engages in interactions with companies</a> before taking any action with respect to safety issues. The frequent defence of safety by companies raises the question about what effect, if any, the positions they take during interactions with Health Canada have on eventual safety actions that Health Canada takes.</p>
<p>The 2011 <a href="https://publications.gc.ca/collections/collection_2012/bvg-oag/FA1-2011-2-4-eng.pdf">Auditor General’s report</a> pointed to serious problems in the way that Health Canada communicates with the public and health-care professionals about drug safety problems, such as not disclosing information on the status of conditionally approved drugs.</p>
<p>In order to reassure Canadians that their interests are coming first, Health Canada should be completely transparent about how it evaluates safety information and makes safety decisions. We need to know that companies’ claims about the safety of their products are not altering decisions that Health Canada makes.</p><img src="https://counter.theconversation.com/content/172835/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2018-2021, Joel Lexchin received payments for being on a panel at the American Diabetes Association, for talks at the Toronto Reference Library, for writing a brief in an action for side effects of a drug for Michael F. Smith, Lawyer and a second brief on the role of promotion in generating prescriptions for Goodmans LLP and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p>When drugs are taken off the market because they are either unsafe or don’t work, do pharma companies admit that there are problems? Or do they deny the evidence?Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, Emergency Physician at University Health Network, Associate Professor of Family and Community Medicine, University of TorontoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1724842021-11-24T19:04:13Z2021-11-24T19:04:13ZDivided and paralysed, can the WTO negotiate a pandemic recovery plan that is fair for all?<figure><img src="https://images.theconversation.com/files/433584/original/file-20211123-18938-1o0d2vw.jpg?ixlib=rb-1.1.0&rect=5%2C0%2C3742%2C2815&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>Hard on the heels of the political deal-making by major powers and corporate lobbyists at the COP26 climate conference, similar manoeuvres are shaping the World Trade Organization’s (WTO) 12th Ministerial Conference (<a href="https://www.wto.org/english/thewto_e/minist_e/mc12_e/mc12_e.htm">MC12</a>), scheduled to begin on November 30 in Geneva. </p>
<p>The decision to hold an in-person negotiating conference of ministers from 164 countries in the midst of a pandemic, and as Europe undergoes another surge, is controversial. </p>
<p>Aside from concerns about safety, there are serious questions about the legitimacy of decisions that will be made under these conditions, including the expected absence of a number of trade ministers, mainly from developing countries.</p>
<p>Ministers with no commercial flights operating from their countries may be unable to travel. Those who can attend face onerous and expensive transit and quarantine arrangements. The size of delegations has been severely limited to facilitate social distancing and reduce processing queues. </p>
<p>At present, only certain vaccines, mainly those used in richer countries, will secure a pass for automatic entry into meeting venues. Ministers and officials who used non-EU-approved vaccines will be subject to periodic testing.</p>
<p>There is also a clampdown on dissent. Swiss authorities have refused authorisation – sought by one of their own parliamentarians – for five protesters to hold placards calling for action on COVID-19 in front of the WTO building. Non-government organisations, an important resource for many developing country delegations, have been <a href="https://ourworldisnotforsale.net/2021_R_postpone_MC12">denied space</a> at the main venue.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1445082581817516035"}"></div></p>
<h2>WTO in crisis</h2>
<p>All this is bad enough for a “member-driven organisation” that makes decisions by consensus. But this conference is shaping up as the most important in the WTO’s 26 years. It is widely agreed the organisation faces an existential crisis. Every one of its core functions – negotiations, dispute settlement, notifications – has broken down.</p>
<p>The <a href="https://www.wto.org/english/tratop_e/dda_e/dda_e.htm">Doha “development” round</a> of negotiations, launched in 2001, promised poorer countries a rebalancing of global trade rules that were designed by and for powerful countries and their corporations. But the Doha round has been moribund for over a decade. </p>
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Read more:
<a href="https://theconversation.com/old-wine-in-new-bottles-why-the-nz-uk-free-trade-agreement-fails-to-confront-the-challenges-of-a-post-covid-world-170621">Old wine in new bottles – why the NZ-UK free trade agreement fails to confront the challenges of a post-COVID world</a>
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<p>At the last ministerial conference four years ago, self-selected groups of members, led by rich countries including New Zealand and Australia, announced they were launching alternative “plurilateral” processes to bypass the WTO’s consensus-based multilateral process – without any mandate to do so. They plan to legitimise those processes at the MC12.</p>
<p>Furthermore, the WTO’s dispute settlement system, considered the jewel in its crown, is paralysed. The US <a href="https://www.reuters.com/world/us/us-committed-wto-wants-it-succeed-trade-rep-tai-says-2021-10-14/">refuses to approve</a> new appointments to the WTO’s Appellate Body until other members agree to its demands for reform. The last judge’s appointment expired in November 2020.</p>
<p>The more powerful WTO members have a raft of other demands. These include severely reducing the number of “developing” countries entitled to special and differential treatment, changes to the mechanism to monitor compliance, and other institutional arrangements.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/433586/original/file-20211123-13-1wboldi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/433586/original/file-20211123-13-1wboldi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/433586/original/file-20211123-13-1wboldi.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/433586/original/file-20211123-13-1wboldi.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/433586/original/file-20211123-13-1wboldi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/433586/original/file-20211123-13-1wboldi.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/433586/original/file-20211123-13-1wboldi.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A Washington protest against the visiting German chancellor’s opposition to an emergency WTO waiver for vaccine patents.</span>
<span class="attribution"><span class="source">GettyImages</span></span>
</figcaption>
</figure>
<h2>The pandemic factor</h2>
<p>These fractures have become fissures in recent years and COVID-19 has brought matters to a head. </p>
<p>Sixty-four developing countries have proposed a temporary waiver of rules in the WTO’s Agreement on Intellectual Property Rights (<a href="https://www.wto.org/english/tratop_e/trips_e/trips_e.htm">TRIPS</a>) that guarantee Big Pharma’s rights over COVID-related vaccines and technologies. The waiver is essential to supply affordable generic versions to the 98% of people in low-income countries who are not yet fully vaccinated.</p>
<p>A recent <a href="https://www.oxfam.org/en/press-releases/pfizer-biontech-and-moderna-making-1000-profit-every-second-while-worlds-poorest">Oxfam report</a> estimated Pfizer and Moderna are expected to take in a combined US$93 billion next year on sales of the vaccines they developed with significant public subsidies. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/new-zealand-is-overdue-for-an-open-and-honest-debate-about-21st-century-trade-relations-160922">New Zealand is overdue for an open and honest debate about 21st-century trade relations</a>
</strong>
</em>
</p>
<hr>
<p>The EU, UK and Switzerland are leading the opposition, supported by their pharmaceutical industries. New Zealand supports a limited version of the waiver, but its ambassador to the WTO, David Walker, is leading a parallel initiative that undermines it. </p>
<p>Walker was tasked by the director-general, not the WTO members, with facilitating a COVID-19 recovery plan. The “Walker process” has been <a href="https://twn.my/title2/wto.info/2021/ti211122.htm">heavily criticised</a> for marginalising the priorities of the least-developed and developing countries. There is a real potential for this to negatively affect New Zealand’s reputation with those nations at the WTO. </p>
<p>The proposed Declaration and Action Plan, prepared on Walker’s “<a href="https://www.bilaterals.org/?wto-response-to-the-pandemic">own responsibility</a>”, have not been developed through the WTO’s normal process of negotiations. Extraordinarily, the text was not tabled in the General Council meeting on November 22. This meant members could not discuss (or reject) it, although it has since been leaked. </p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1460712650229403651"}"></div></p>
<h2>Hope for a better regime</h2>
<p>Critics object that Walker’s proposal is heavily skewed towards the interests of richer countries and that it uses COVID-19 as a back door to promote more liberalisation, reflecting the agenda for WTO reform being advanced by the “Ottawa Group” of countries, including New Zealand and Australia. Walker has ruled out including the waiver or other changes to WTO intellectual property rules. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/the-big-barriers-to-global-vaccination-patent-rights-national-self-interest-and-the-wealth-gap-153443">The big barriers to global vaccination: patent rights, national self-interest and the wealth gap</a>
</strong>
</em>
</p>
<hr>
<p>As the MC12 heads for a showdown on all these and other issues, the strategies being pursued by the New Zealand and Australian governments to keep the WTO on life support are counterproductive. </p>
<p>Even if those attending the conference manage to reach agreement on some final declaration – which eluded them at the last ministerial conference in 2017 – the refusal of its more powerful members to address the organisation’s systemic failings ensures it will continue its spiralling decline. </p>
<p>Longtime critics of the WTO hope this may finally open the door to re-envisioning a new, more equitable international trading regime that can address the challenges of the 21st century highlighted by the pandemic.</p><img src="https://counter.theconversation.com/content/172484/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jane Kelsey does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>With the World Trade Organization’s 12th Ministerial Conference – arguably its most important ever – happening next week, attempts to keep it ‘on life support’ may be counterproductive.Jane Kelsey, Professor of Law, University of Auckland, Waipapa Taumata RauLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1694592021-11-11T01:24:16Z2021-11-11T01:24:16ZMarket immunity? How public safety warnings have little impact on drug sales volumes or company share prices<figure><img src="https://images.theconversation.com/files/431212/original/file-20211110-25-1vhthsp.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C5967%2C3721&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Shutterstock</span></span></figcaption></figure><p>The race by pharmaceutical companies to find effective vaccines for COVID-19 has shone a global spotlight on the trade-offs regulators face in approving new drugs.</p>
<p>Under the system used by drug regulators in the US, Europe and elsewhere, drug companies need only show from clinical trials that new drugs have short-term safety and efficacy in order to gain approval.</p>
<p>So, what happens if something goes wrong longer term? </p>
<p>Specifically, does the market itself punish drug companies when regulators issue warnings about a product’s safety, or withdraw it entirely? <a href="https://onlinelibrary.wiley.com/doi/epdf/10.1002/hec.4440">Our latest research</a> set out to answer that question.</p>
<h2>Warnings after the fact</h2>
<p>Companies don’t need to demonstrate a drug’s long-term safety and efficacy. The limited length of clinical trials is allowed in order to keep the cost of developing drugs from being so high that new drugs don’t get developed.</p>
<p>There are also ethical problems with long trials – would you like to spend three years randomly assigned to take a drug you quickly realise is ineffective, or worse?</p>
<p>But our system brings the risk that new drugs can turn out to cause long-term problems undetected at the time of approval – opioid pain killers being a prime example.</p>
<p>Instead, after a drug gets approved, doctors or patients can report “adverse drug events” which regulators can investigate. The regulators may issue a new warning to go on a drug’s label or, in extreme cases, the drug may be withdrawn from the market, as happened with the <a href="https://www.npr.org/2007/11/10/5470430/timeline-the-rise-and-fall-of-vioxx">painkiller Vioxx</a> in 2004.</p>
<figure class="align-center ">
<img alt="Covid vaccine vials" src="https://images.theconversation.com/files/431219/original/file-20211110-13-svzf9w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/431219/original/file-20211110-13-svzf9w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=338&fit=crop&dpr=1 600w, https://images.theconversation.com/files/431219/original/file-20211110-13-svzf9w.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=338&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/431219/original/file-20211110-13-svzf9w.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=338&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/431219/original/file-20211110-13-svzf9w.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=424&fit=crop&dpr=1 754w, https://images.theconversation.com/files/431219/original/file-20211110-13-svzf9w.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=424&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/431219/original/file-20211110-13-svzf9w.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=424&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">COVID vaccine development has highlighted the trade-offs regulators face in approving new drugs.</span>
<span class="attribution"><span class="source">Shutterstock</span></span>
</figcaption>
</figure>
<h2>Regulation versus market signals</h2>
<p>New safety warnings can vary in seriousness, with examples in our sample ranging from risk of permanent skin discolouration from certain <a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-reporting-permanent-skin-color-changes-associated-use-daytrana">dermal patches</a>, up to increased risk of potentially fatal <a href="https://www.empr.com/uncategorized/avandia-label-updated-to-include-cardiovascular-risk-warnings/">heart</a> or <a href="https://www.drugwatch.com/news/2014/01/28/fda-limits-acetaminophen-liver-damage/">liver damage</a>, or <a href="https://www.webmd.com/depression/news/20070502/new-antidepressant-suicide-warning">suicidal ideation</a>. </p>
<p>In the US, the Food and Drug Administration (FDA) therefore further distinguishes between new regular warnings and more serious “boxed” warnings that are urgent enough to be framed and placed at the top of a drug’s information label.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/the-price-of-a-drug-should-be-based-on-its-therapeutic-benefits-not-just-what-the-market-will-bear-149586">The price of a drug should be based on its therapeutic benefits – not just what the market will bear</a>
</strong>
</em>
</p>
<hr>
<p>Do regulators get the balance right between encouraging new drug creation and safeguarding public health from unforeseen problems with newly approved drugs? </p>
<p>The burden would not fall on regulators alone if markets tended to “punish” companies whose drugs turn out to cause longer-term problems. This would create additional market incentives for companies to avoid such outcomes. </p>
<p>So do markets help keep us safe when we take approved drugs?</p>
<h2>Testing the market</h2>
<p>We first tested how total sales volumes of individual drugs across four broad categories in the US and the UK hospital and retail sectors are affected when each country’s respective regulator issues new safety warnings. </p>
<p>Some of these drugs were sold by only one or two companies, while others were sold by many, but we focused on whether warnings significantly affected total sales of individual drugs. </p>
<p>We included individual drugs across the four drug categories of diabetes, analgesic pain relievers (including opioids), nervous system analeptics for calming (including antipsychotics), and nervous system psychoanaleptic stimulants (including antidepressants).</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/how-pharma-can-build-trust-in-covid-19-vaccines-transparency-on-trials-and-side-effects-150270">How pharma can build trust in COVID-19 vaccines: Transparency on trials and side-effects</a>
</strong>
</em>
</p>
<hr>
<p>Beyond asking whether warnings affected total sales volumes of individual drugs, we next tested whether they affected the share price of the individual publicly listed companies selling the drug, in the days surrounding the announcement of the safety warning.</p>
<p>Share prices matter because they should capture whether shareholders in the affected company believe the warning will lower its future profits. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/431215/original/file-20211110-13-10el7qr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/431215/original/file-20211110-13-10el7qr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/431215/original/file-20211110-13-10el7qr.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/431215/original/file-20211110-13-10el7qr.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/431215/original/file-20211110-13-10el7qr.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/431215/original/file-20211110-13-10el7qr.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/431215/original/file-20211110-13-10el7qr.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Prescription opioids were hailed as a breakthrough in pain management but created an addiction epidemic.</span>
<span class="attribution"><span class="source">Shutterstock</span></span>
</figcaption>
</figure>
<h2>Little impact on sales</h2>
<p>We followed new warnings, sales and share prices for the US and UK over 12 years, from 2006 to 2017. Across a variety of statistical methods, we found surprisingly little evidence that new safety warnings affect the sales volume of the relevant drugs within our four categories.</p>
<p>The exceptions were in the US (with the UK regulator’s warnings never having a measurable effect on sales in that country). Specifically, if we excluded diabetic drugs, FDA warnings significantly lowered subsequent US sales of the other three drug categories if pooled together, but didn’t significantly lower sales if each broad category of drug was considered separately. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/covid-vaccine-trials-were-a-triumph-now-we-need-a-similar-system-for-antibiotics-162130">COVID vaccine trials were a triumph – now we need a similar system for antibiotics</a>
</strong>
</em>
</p>
<hr>
<p>Similarly, having “at least one new boxed warning” during our sample period significantly lowered US hospital sales volume for all four categories of drug combined, but not significantly for each category separately, and not for US retail sales. </p>
<p>At the extreme, we found having at least ten new FDA warnings, or at least three new FDA boxed warnings, significantly lowered total sales volumes in all categories in both US retail and hospitals. </p>
<h2>Share prices unaffected</h2>
<p>We found even less evidence that warnings affected drug company share prices. The effects of warnings were small, sensitive to our choice of time span around the warning, and statistically insignificant. The single significant exception used a 25-day time span following warnings issued by the UK regulator.</p>
<p>We conclude that if society judges the problems identified by post-approval warnings to be rare or mild, then perhaps there is no reason to think sales volume or company share price should take a hammering.</p>
<p>The current system might then be doing a good job of balancing the cost of new drug development with safeguarding public health against the risk of unforeseen negative side effects.</p>
<p>But if society does judge the problems being identified in new warnings to be too common or serious, then the balance of our evidence is that markets do not punish companies that sell such drugs. </p>
<p>If the market does not fulfil this function, then, it must fall to regulators alone to insist that pre-approval drug trials be run for longer periods for more patients.</p><img src="https://counter.theconversation.com/content/169459/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>A new study suggests the market alone will not deter or punish pharmaceutical companies whose products turn out to have adverse effects after they have been approved.Jeremy Edmund Clark, Associate Professor, Department of Economics and Finance, Business School, University of CanterburyJedrzej Bialkowski, Professor and Head of Department, Economics and Finance, University of CanterburyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1694432021-10-29T12:37:26Z2021-10-29T12:37:26ZAntibiotic resistance is at a crisis point – government support for academia and Big Pharma to find new drugs could help defeat superbugs<figure><img src="https://images.theconversation.com/files/428912/original/file-20211027-17-sshvdh.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2119%2C1414&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Bacteria that are resistant to every available antibiotic in the U.S. already exist.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/bacteria-royalty-free-image/909752640">Rodolfo Parulan Jr/Moment via Getty Images</a></span></figcaption></figure><p>Antibiotic resistance poses one of the most important health challenges of the 21st century. And time has already run out to stop its dire consequences.</p>
<p>The rise of <a href="https://www.cdc.gov/drugresistance/biggest-threats.html">multidrug-resistant bacteria</a> has already led to a significant increase in human disease and death. The U.S. Centers for Disease Control and Prevention estimates that approximately <a href="https://www.cdc.gov/drugresistance/biggest-threats.html">2.8 million people</a> worldwide are infected with antibiotic-resistant bacteria, accounting for 35,000 deaths each year in the U.S. and <a href="https://www.who.int/news/item/29-04-2019-new-report-calls-for-urgent-action-to-avert-antimicrobial-resistance-crisis">700,000 deaths around the globe</a>.</p>
<p>A <a href="https://www.oie.int/fileadmin/Home/eng/Media_Center/docs/pdf/IACG2019/IACG_final_report_EN.pdf">2019 joint report</a> by the United Nations, World Health Organization and World Organization for Animal Health states that drug-resistant diseases could cause 10 million deaths each year by 2050 and force up to 24 million people into extreme poverty by 2030 <a href="https://www.who.int/news/item/29-04-2019-new-report-calls-for-urgent-action-to-avert-antimicrobial-resistance-crisis">if no action is taken</a>. Superbugs are already able to evade all existing treatments – a 70-year-old woman from Nevada died in 2016 from a bacterial infection <a href="https://www.statnews.com/2017/01/12/nevada-woman-superbug-resistant/">resistant to every available antibiotic in the U.S.</a></p>
<p>I am a <a href="https://scholar.google.com/citations?user=zLwzHqcAAAAJ&hl=en">biochemist and microbiologist</a> who has been researching and teaching about antibiotic development and resistance over the past 20 years. I believe that solving this crisis requires more than just proper antibiotic use by doctors and patients. It also requires mutual investment and collaboration across industries and the government. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/ZvhFeGEDFC8?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Antibiotics revolutionized modern medicine. But improper usage of antibiotics and lack of research funding have led to a growing crisis of antibiotic-resistant bacteria.</span></figcaption>
</figure>
<h2>How do bacteria become resistant to drugs?</h2>
<p>In order to survive, bacteria naturally <a href="https://theconversation.com/we-know-why-bacteria-become-resistant-to-antibiotics-but-how-does-this-actually-happen-59891">evolve to become resistant</a> to the drugs that kill them. They do this via two methods: genetic mutation and horizontal gene transfer.</p>
<p><a href="https://doi.org/10.1111/j.1469-0691.2006.01492.x">Genetic mutation</a> occurs when the bacteria’s DNA, or genetic material, randomly changes. If these changes let the bacteria evade an antibiotic that would have otherwise killed it, it will be able to survive and pass on this resistance when it reproduces. Over time, the proportion of resistant bacteria will increase as nonresistant bacteria are killed by the antibiotic. Eventually, the drug will no longer work on these bacteria because they all have the mutation for resistance.</p>
<p>The other method bacteria use is <a href="https://doi.org/10.1093/emph/eov018">horizontal gene transfer</a>. Here, one bacterium acquires resistance genes from another source, either through their environment or directly from another bacterium or bacterial virus.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/428916/original/file-20211027-25-1jjmhcf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Diagram of bacterial horizontal gene transfer types." src="https://images.theconversation.com/files/428916/original/file-20211027-25-1jjmhcf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/428916/original/file-20211027-25-1jjmhcf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=306&fit=crop&dpr=1 600w, https://images.theconversation.com/files/428916/original/file-20211027-25-1jjmhcf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=306&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/428916/original/file-20211027-25-1jjmhcf.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=306&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/428916/original/file-20211027-25-1jjmhcf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=384&fit=crop&dpr=1 754w, https://images.theconversation.com/files/428916/original/file-20211027-25-1jjmhcf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=384&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/428916/original/file-20211027-25-1jjmhcf.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=384&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Bacteria can gain resistance via infection from a virus (transduction), picking it up from the environment (transformation) or direct transfer from other bacteria (conjugation).</span>
<span class="attribution"><a class="source" href="https://commons.wikimedia.org/wiki/File:Bacterial_horizontal_gene_transfer.jpg">2013MMG320B/Wikimedia Commons</a></span>
</figcaption>
</figure>
<p>But the antibiotic resistance crisis is largely <a href="https://doi.org/10.3390/w13192693">anthropogenic, or human-made</a>. Factors include the overuse and abuse of antibiotics, as well as a lack of regulations and enforcement pertaining to proper use. For example, doctors prescribing antibiotics for <a href="https://www.mayoclinic.org/healthy-lifestyle/consumer-health/in-depth/antibiotics/art-20045720">nonbacterial infections</a> and patients not completing their <a href="https://theconversation.com/why-you-really-should-take-your-full-course-of-antibiotics-81704">prescribed course of treatment</a> give bacteria the chance to evolve resistance.</p>
<p>There are also no regulations on <a href="https://dx.doi.org/10.3390%2Fmolecules23040795">antibiotic use in animal agriculture</a>, including controlling leakage into the surrounding environment. <a href="https://www.pewtrusts.org/en/research-and-analysis/articles/2019/10/28/fda-should-expedite-new-rules-on-antibiotic-use-in-food-animals">Only recently</a> has there been a push for more antibiotic oversight in agriculture in the U.S. As an October 2021 report by the National Academies of Sciences, Engineering and Medicine noted, antibiotic resistance is an issue that <a href="https://www.nationalacademies.org/news/2021/10/combating-antimicrobial-resistance-globally-requires-maintaining-safety-of-available-antibiotics-and-a-robust-pipeline-animal-and-environmental-health-strategies-also-needed">connects human, environmental and animal health</a>. Effectively addressing one facet requires addressing the others.</p>
<h2>The antibiotic discovery void</h2>
<p>One of the major reasons for the resistance crisis is the stalling of antibiotic development over the past 34 years. Scientists call this the <a href="https://www.reactgroup.org/toolbox/understand/how-did-we-end-up-here/few-antibiotics-under-development/">antibiotic discovery void</a>. </p>
<p>Researchers discovered the last class of highly effective antibiotics in 1987. Since then, no new antibiotics have made it out of the lab. This is partly because there was <a href="https://doi.org/10.1093/fqsafe/fyz003">no financial incentive</a> for the pharmaceutical industry to invest in further research and development. Antibiotics at the time were also effective at what they did. Unlike chronic diseases like hypertension and diabetes, bacterial infections don’t typically require ongoing treatment, and so have a lower return on investment.</p>
<p><iframe id="49G1P" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/49G1P/2/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<p>Reversing this trend requires investment not just in drug development, but also in the basic research that allows scientists to understand how antibiotics and bacteria work in the first place. </p>
<p><a href="https://www.formpl.us/blog/basic-research">Basic research</a> focuses on advancing knowledge rather than developing interventions to solve a specific problem. It gives scientists the opportunity to ask new questions and think long-term about the natural world. A better understanding of the driving forces behind antibiotic resistance can lead to innovations in drug development and techniques to combat multidrug-resistant bacteria.</p>
<p>Basic science also provides <a href="https://dx.doi.org/10.1210%2Fme.2014-1343">opportunities to mentor the next generation of researchers</a> tasked with solving problems like antibiotic resistance. By teaching students about the fundamental principles of science, basic scientists can train and inspire the future workforce with the passion, aptitude and competency to address problems that require scientific understanding to solve.</p>
<h2>Collaboration by triangulation</h2>
<p>Many scientists agree that addressing antibiotic resistance <a href="https://www.scientificamerican.com/article/how-to-solve-the-problem-of-antibiotic-resistance/">requires more than just responsible use</a> by individuals. The federal government, academia and pharmaceutical companies need to partner together in order to effectively tackle this crisis – what I call collaboration by triangulation.</p>
<p>[<em>The Conversation’s science, health and technology editors pick their favorite stories.</em> <a href="https://theconversation.com/us/newsletters/science-editors-picks-71/?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=science-favorite">Weekly on Wednesdays</a>.]</p>
<p>Collaboration between basic scientists in academia and pharmaceutical companies is one pillar of this effort. While basic science research provides the knowledge foundation to discover new drugs, pharmaceutical companies have the infrastructure to produce them at a scale typically unavailable in academic settings.</p>
<p>The remaining two pillars involve financial and legislative support from the federal government. This includes enhancing research funding for academics and changing current policies and practices that <a href="https://doi.org/10.1093/ofid/ofaa001">impede, rather than offer, incentives</a> for pharmaceutical company investment in antibiotic development.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/428915/original/file-20211027-21-1et43ur.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Antibiotic capsules filling white background." src="https://images.theconversation.com/files/428915/original/file-20211027-21-1et43ur.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/428915/original/file-20211027-21-1et43ur.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/428915/original/file-20211027-21-1et43ur.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/428915/original/file-20211027-21-1et43ur.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/428915/original/file-20211027-21-1et43ur.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/428915/original/file-20211027-21-1et43ur.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/428915/original/file-20211027-21-1et43ur.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Partnership between academia, pharmaceutical companies and the government could help expedite antibiotic development.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/colorful-of-antibiotic-capsules-pills-isolated-on-royalty-free-image/887228372">Fahroni/iStock via Getty Images Plus</a></span>
</figcaption>
</figure>
<p>To that end, a bipartisan bill proposed in June 2021, the <a href="https://www.statnews.com/2021/06/25/pasteur-act-help-fight-superbugs-antimicrobial-resistance/">Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act</a>, aims to fill the discovery void. If passed into law, the bill would pay developers contractually agreed-upon amounts to research and develop antimicrobial drugs for <a href="https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity#howlongpatentterm">a time period</a> that ranges from five years up to the end of the patent.</p>
<p>I believe the passage of this act would be an important step in the right direction to address antibiotic resistance and the threat it poses to human health in the U.S. and around the globe. A monetary incentive to take up basic research around new ways to kill dangerous bacteria seems to me like the world’s best available option for emerging from the antibiotic resistance crisis.</p><img src="https://counter.theconversation.com/content/169443/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Andre Hudson receives funding from the National Institutes of Health. </span></em></p>If no action is taken to address antibiotic resistance, infections from multidrug-resistant bacteria could cause 10 million deaths each year by 2050.André O. Hudson, Professor and Head of the Thomas H. Gosnell School of Life Sciences, Rochester Institute of TechnologyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1625722021-08-23T12:03:26Z2021-08-23T12:03:26ZHow a vial of Pfizer COVID-19 vaccine travels from a lab in Missouri to an arm in Bangladesh<figure><img src="https://images.theconversation.com/files/416375/original/file-20210816-22-klxfz7.jpg?ixlib=rb-1.1.0&rect=154%2C187%2C7194%2C4605&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A Bangladeshi man gets his jab.</span> <span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakBangladesh/6546941f2ebf4f7d8a26625ed5d5a5ab/photo?Query=Bangladesh%20AND%20vaccine&mediaType=photo&sortBy=arrivaldatetime:desc&dateRange=Anytime&totalCount=33&currentItemNo=4">AP Photo/Mahmud Hossain Opu</a></span></figcaption></figure><p>Inoculating the planet from COVID-19 presents an unprecedented logistical challenge like none we’ve seen before. Mobilizing for a world war may be the closest comparison – but in this case, the enemy is invisible and everywhere.</p>
<p>Some of the vaccines require <a href="https://theconversation.com/how-mrna-vaccines-from-pfizer-and-moderna-work-why-theyre-a-breakthrough-and-why-they-need-to-be-kept-so-cold-150238">super-cold storage</a> at virtually all points along the journey until they reach someone’s upper arm. And the vaccines are <a href="https://www.dw.com/en/the-covid-19-vaccines-where-do-they-come-from-where-will-they-go/a-56134178">primarily being produced</a> in wealthier countries, though the need – especially now – <a href="https://www.nytimes.com/2021/08/02/world/europe/covax-covid-vaccine-problems-africa.html?action=click&module=Spotlight&pgtype=Homepage">is greatest in the poorest</a>.</p>
<p>While <a href="https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracker.html">many rich countries</a> such as Israel, Canada and those of the U.K. have managed to inoculate most of their citizens, the <a href="https://fortune.com/2021/06/30/covid-vaccines-global-vaccination-rates-by-country/">vast majority of people</a> overall have yet to receive a single dose.</p>
<p><a href="https://scholar.google.com/citations?user=ncDgo0QAAAAJ&hl=en&oi=ao">I have been studying global supply chains</a> for over two decades, including those for drugs and other health-related products. To illustrate the process and how complicated and challenging it is, I’ll take you on the journey of a single dose of Pfizer – which received <a href="https://www.npr.org/sections/coronavirus-live-updates/2021/08/23/1030251410/pfizer-covid-vaccine-fda-approval">full Food and Drug Administration approval</a> on Aug. 23, 2021 – all the way from a factory in Missouri to an arm in Bangladesh. </p>
<h2>From Missouri to Massachusetts to Michigan</h2>
<p>Even though it’s commonly known as the Pfizer vaccine, it was actually developed <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-co-develop-potential-covid-19-vaccine">under a partnership with BioNTech</a>, which is based in Germany. </p>
<p><a href="https://www.pfizer.com/news/hot-topics/mrna_technology_at_the_forefront_during_global_pandemic">It is one</a> of <a href="https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_15July2021.pdf">two vaccines that use new mRNA technology</a>, which <a href="https://theconversation.com/how-mrna-vaccines-from-pfizer-and-moderna-work-why-theyre-a-breakthrough-and-why-they-need-to-be-kept-so-cold-150238">provides genetic instructions that encode a viral protein</a>. Once the vaccinated person’s cells start making the coronavirus protein, it prompts their immune system to design powerful antibodies that can neutralize the virus if they ever encounter it.</p>
<p>A vaccine dose’s <a href="https://www.nytimes.com/interactive/2021/health/pfizer-coronavirus-vaccine.html">60-day journey to distribution starts with raw ingredients</a> in a Pfizer factory in Chesterfield, Missouri, a suburb of St. Louis. This factory produces the key raw material called plasmids, which are basically strands of DNA that contain the genetic instructions for building coronavirus proteins. </p>
<p>Bottles of the DNA material are frozen, bagged, sealed and packed into a container and shipped to Andover, Massachusetts. There, the DNA is processed into mRNA, which is the active ingredient in the vaccine – also referred to as the “drug substance.” </p>
<p>The mRNA is packaged in plastic bags – each containing enough material to produce 10 million doses – frozen and shipped to Kalamazoo, Michigan, where the vaccine reaches the last stage of the process: formulation and filling.</p>
<p>First, the drug substance is combined with lipid nanoparticles – basically fat – to protect the mRNA and help it enter the human cells. Next, the combination is squirted into glass vials, six doses per vial, packaged and frozen for distribution. </p>
<p>Here I have presented a simplified three-step process. Making a vaccine, however, is more much complex, requiring more than 200 different materials supplied by factories spread across the world. </p>
<figure class="align-center ">
<img alt="A man wearing protective gear and a yellow shirt dumps dry ice into a box containing Pfizer vaccines" src="https://images.theconversation.com/files/416804/original/file-20210818-27-1e9hhe2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/416804/original/file-20210818-27-1e9hhe2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/416804/original/file-20210818-27-1e9hhe2.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/416804/original/file-20210818-27-1e9hhe2.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/416804/original/file-20210818-27-1e9hhe2.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/416804/original/file-20210818-27-1e9hhe2.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/416804/original/file-20210818-27-1e9hhe2.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Pfizer’s custom boxes use dry ice to keep vaccine vials at ultra-cold temperatures.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakWastedVaccineDoses/dc6f3fc52c3f41be963574cb4f71aa59/photo?Query=Pfizer%20AND%20boxes&mediaType=photo&sortBy=arrivaldatetime:desc&dateRange=Anytime&totalCount=203&currentItemNo=38">AP Photo/Morry Gash, Pool</a></span>
</figcaption>
</figure>
<h2>Keeping vials super-cold</h2>
<p>While awaiting distribution, the Pfizer vaccine vials must be <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-covid-19-vaccine-stability-data">stored at temperatures</a> from minus 112 F to minus 76 F (minus 80 C to minus 60 C) in ultra-cold freezers.</p>
<p>To put this in perspective, the average annual temperature at the South Pole <a href="https://www.climatestotravel.com/climate/antarctica">is about minus 58 F (minus 50 C)</a>. Ice creams and frozen steaks are kept, during storage and transport, <a href="https://cwi-logistics.com/news/how-cold-does-a-warehouse-have-to-be-to-keep-ice-cream//">below minus 20 F (minus 29 C)</a>.</p>
<p>Pfizer designed its own custom cooler box to make it easier to transport its vaccines across the U.S. and around the world. <a href="https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/pfizer-bioNTech-faqs.html">Vials are placed into trays</a>, with 195 vials per tray. Each box can fit five trays. Each box of 5,850 doses has a GPS tracker and contains a monitor that keeps a log of the temperature. </p>
<p>Pfizer’s custom boxes don’t require any other specialized equipment to transport the vaccines, and the ultra-cold temperature in the cooler boxes is maintained during transport using dry ice that needs to be replaced every five days.</p>
<p>A problem with the dry ice is that it’s carbon dioxide in solid form. The dry ice gradually turns from solid to gas, which can be dangerous without proper ventilation.</p>
<p>Once it has a shipment ready for delivery to a given destination, Pfizer <a href="https://www.biopharmadive.com/news/coronavirus-vaccine-freight-forwarder-distribution/589880/">contacts one of the global freight carriers</a> it’s partnered with, such as UPS or DHL, which picks up a designated number of boxes and ships them directly to the country in need within one or two days. </p>
<figure class="align-center ">
<img alt="Two men stand next to a cold storage warehouse that contains boxes of Pfizer vaccine." src="https://images.theconversation.com/files/416808/original/file-20210818-15-1m9pi0r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/416808/original/file-20210818-15-1m9pi0r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/416808/original/file-20210818-15-1m9pi0r.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/416808/original/file-20210818-15-1m9pi0r.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/416808/original/file-20210818-15-1m9pi0r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/416808/original/file-20210818-15-1m9pi0r.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/416808/original/file-20210818-15-1m9pi0r.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Countries must have ultra-cold storage infrastructure, such as this warehouse in Turkey, to accept doses of Pfizer’s vaccine.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakTurkey/5d1afecb5c184ffd9b23d67785538aec/photo?Query=cold%20storage%20vaccine&mediaType=photo&sortBy=arrivaldatetime:desc&dateRange=Anytime&totalCount=100&currentItemNo=9">Turkish Health Ministry via AP</a></span>
</figcaption>
</figure>
<h2>A vial’s last mile</h2>
<p>For a country to receive Pfizer vaccines, it needs to have the capacity to store ultra-cold medical items.</p>
<p>While this isn’t a problem for wealthier nations, poorer countries are less likely to have the necessary infrastructure in place. </p>
<p>Upon arrival in a country, the shipment goes into a deep freezer, typically at the airport or a central storage facility, until it is ready to be used. The vaccine has to be kept in ultra-cold storage until within about a month before it’s injected into someone’s shoulder. </p>
<p>In poorer countries that do have the right infrastructure, such as Bangladesh, distribution still needs to be restricted to a few select hospitals in large urban areas where there are ultra-cold storage facilities. For example, Bangladesh will use Pfizer vaccines at <a href="https://www.dhakatribune.com/bangladesh/2021/06/30/7-dhaka-vaccine-centres-to-administer-pfizer-jabs-from-thursday">seven hospitals in its capital city, Dhaka</a>.</p>
<p>The frosty journey of the Pfizer vaccine itself is just one part of getting people their jabs. Ancillary supplies needed for vaccination include special syringes delivering a 0.3-milliliter (mL) dose, needles, sterile alcohol pads and personal protective equipment for the health care worker delivering the shot.</p>
<p>Preparing the injection of the Pfizer vaccine requires a complex dance. First the nurse thaws the vaccine in a refrigerator to a range of 36 F to 46 F (2 C to 8 C), where it can be held for up to 31 days. Just before vaccination, the nurse brings the vial to room temperature of 36 F to 77 F (2 C to 25 C), at which it can survive no more than six hours. </p>
<p>Because the Pfizer vaccine is shipped as a concentrate, the <a href="https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/diluent-poster.pdf">nurse needs to dilute it with 1.8 milliliters of saline</a>, resulting in a mixture sufficient for six doses. </p>
<p>There’s a further complication in that many low- and medium-income countries use syringes that ensure a fixed maximum dose and are automatically disabled after single use. This takes away the guesswork and prevents mistakes. UNICEF is responsible for delivering these extra supplies to poorer countries that are getting their vaccines through COVAX, the <a href="https://www.gavi.org/covax-facility">global initiative set up to distribute</a> COVID-19 vaccines to low- and middle-income countries. </p>
<figure class="align-center ">
<img alt="Several syringes containing diluted 0.3 mL doses of Pfizer vaccine sit in a box" src="https://images.theconversation.com/files/416807/original/file-20210818-15-ho04l0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/416807/original/file-20210818-15-ho04l0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/416807/original/file-20210818-15-ho04l0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/416807/original/file-20210818-15-ho04l0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/416807/original/file-20210818-15-ho04l0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/416807/original/file-20210818-15-ho04l0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/416807/original/file-20210818-15-ho04l0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">The last step of the process before inoculation involves diluting the vaccine with saline to create 0.3-milliliter doses.</span>
<span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/VirusOutbreakCalifornia/6dff429a78cf466b87943fc6e3abe910/photo?Query=pfizer%20AND%20syringes&mediaType=photo&sortBy=arrivaldatetime:asc&dateRange=Anytime&totalCount=226&currentItemNo=67">AP Photo/Jae C. Hong</a></span>
</figcaption>
</figure>
<h2>A monumental achievement</h2>
<p>Other vaccines have much less demanding cold supply chain requirements, don’t require dilution and use syringes with standard dose sizes, allowing more countries to use them, including in rural areas. </p>
<p>Most of the COVID-19 vaccines <a href="https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_15July2021.pdf">approved for use by the World Health Organization</a>, such as those made by AstraZeneca and Johnson & Johnson, require only standard cold storage of 35.6 F to 46.4 F (2 C to 8 C). </p>
<p>I focused on Pfizer in part because it makes up the lion’s share of <a href="https://www.whitehouse.gov/briefing-room/statements-releases/2021/06/10/fact-sheet-president-biden-announces-historic-vaccine-donation-half-a-billion-pfizer-vaccines-to-the-worlds-lowest-income-nations">doses donated by the U.S.</a> to COVAX.</p>
<p>As of Aug. 22, 2021, a <a href="https://ourworldindata.org/covid-vaccinations">total of 4.97 billion COVID-19 vaccine doses</a> had been administered, a feat unimaginable in the fall of 2020. But global coverage has been highly uneven. While a little over half of the population in high-income countries have been vaccinated, only 1.4% of low-income populations have received theirs. Many of these countries are in Africa.</p>
<p>The <a href="https://extranet.who.int/pqweb/sites/default/files/documents/Status_COVID_VAX_15July2021.pdf">development of several vaccines, 10 of which are WHO-approved</a>, <a href="https://covid19.nih.gov/news-and-stories/vaccine-development">many within a year</a>, was a monumental achievement of science and global collaboration – especially since it <a href="https://www.weforum.org/agenda/2020/06/vaccine-development-barriers-coronavirus">previously took on average a decade</a>. </p>
<p>But creating supply chains to deliver all those lifesaving vaccines to people all over the world will be an equally remarkable accomplishment. </p>
<p>[<em>Like what you’ve read? Want more?</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=likethis">Sign up for The Conversation’s daily newsletter</a>.]</p><img src="https://counter.theconversation.com/content/162572/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ravi Anupindi does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Each dose of Pfizer has a long and complex path involving mixing, storage at temperatures colder than the South Pole and specific protocols that must be followed before it becomes a jab.Ravi Anupindi, Professor of Technology and Operations, University of MichiganLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1650822021-08-03T20:06:32Z2021-08-03T20:06:32ZCOVID vaccines offer the pharma industry a once-in-a-generation opportunity to reset its reputation. But it’s after decades of big profits and scandals<figure><img src="https://images.theconversation.com/files/414139/original/file-20210802-24-bh8h6h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://unsplash.com/photos/QwFyqPKyyY0">Elsa Olofsson/Unsplash</a></span></figcaption></figure><p>Just weeks before the first COVID-19 cases emerged, Gallup published its <a href="https://news.gallup.com/poll/266060/big-pharma-sinks-bottom-industry-rankings.aspx">latest poll</a> on America’s views about business. At the bottom of the list of 25 sectors was the pharmaceutical industry. Below advertising. Below oil and gas. Below the banks. </p>
<p>The pandemic and the new vaccines have of course <a href="https://theconversation.com/big-pharmas-covid-19-reputation-boost-may-not-last-heres-why-162975">turned that reputation around</a>, but let’s not forget why the pharmaceutical industry’s credibility sank so low. </p>
<p>Or how the industry got so big. One company, Johnson & Johnson, is currently worth around US$450 billion. About the same as the economy of Norway. </p>
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Read more:
<a href="https://theconversation.com/big-pharmas-covid-19-reputation-boost-may-not-last-heres-why-162975">Big Pharma's COVID-19 reputation boost may not last — here’s why</a>
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<h2>The birth of the behemoths</h2>
<p>The idea of the miraculous potion or cure-all dates back at least as far as Greek mythology. The goddess Panacea even gets a mention in the <a href="https://en.wikipedia.org/wiki/Hippocratic_Oath">Hippocratic Oath</a>. </p>
<p>The rise of the modern pharmaceutical industry is more recent, coming through the 19th century. On the eve of the 20th century, the German company Bayer famously launched its early blockbusters, including “Aspirin” and “Heroin.”</p>
<p>Around this time, US drug-makers were arguing for <a href="https://theconversation.com/the-us-drug-industry-used-to-oppose-patents-what-changed-161319">patent protections</a>, or exclusive rights to market a drug for a specific period of time. By the 1950s, they’d won those arguments, and the US soon became the world’s biggest market for medicines. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/the-us-drug-industry-used-to-oppose-patents-what-changed-161319">The US drug industry used to oppose patents – what changed?</a>
</strong>
</em>
</p>
<hr>
<p>In addition to patents, the other special ingredient for success was the right to market pills directly to doctors, and in the US, directly to consumers via television commercials. </p>
<p>At the dawn of the 21st century, in those dark ages before Facebook and Big Tech, pharmaceuticals was among the most profitable industries on the planet.</p>
<h2>Wonder drugs, miracle cures</h2>
<p>Clearly many medicines extend lives and reduce suffering. And while we need caution with hyperbole, some discoveries are major breakthroughs. </p>
<p>Antibiotics revolutionised the treatment of deadly infections, and gave a boost to science at the same time. </p>
<p>In the 1940s, one of the first-published “<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3164257/">randomised controlled trials</a>” was a test of Streptomycin for the treatment of tuberculosis. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/414244/original/file-20210803-13-1q9a091.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/414244/original/file-20210803-13-1q9a091.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/414244/original/file-20210803-13-1q9a091.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/414244/original/file-20210803-13-1q9a091.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/414244/original/file-20210803-13-1q9a091.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/414244/original/file-20210803-13-1q9a091.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/414244/original/file-20210803-13-1q9a091.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Streptomycin inventor Selman Waksman and two associates test the drug.</span>
<span class="attribution"><a class="source" href="https://commons.wikimedia.org/wiki/File:Waksman,_selman.jpg">New Jersey Agriculture Experimental Station at Rutgers University/Wikimedia Commons</a></span>
</figcaption>
</figure>
<p>In the 1980s, another famous class of wonder drugs was developed, this time to tackle the HIV-AIDS epidemic. The mysterious new virus bringing many people a death sentence would soon become a manageable disease. </p>
<p>And while some cancers remain incurable, others are treated and even prevented with medicines that are simply miraculous.</p>
<h2>Extortionate prices, avoided taxes</h2>
<p>Yet, in each case, the golden drugs have a dark side. As the World Health Organization notes, <a href="https://onlinelibrary.wiley.com/doi/abs/10.5694/mja16.01042">overuse of antibiotics</a> helped make antibiotic-resistance “<a href="https://www.who.int/news-room/fact-sheets/detail/antibiotic-resistance">one of the biggest threats to global health</a>”. </p>
<p>Over-pricing and patent protections for HIV medicines put them out of reach of the world’s poorest, and prices only came down after <a href="https://www.msf.org/access-medicines-depth-access-campaign">massive global campaigns</a> for greater access. </p>
<p>With <a href="https://www.bmj.com/content/325/7358/269?tab=responses">cancer</a>, companies have demanded huge prices for products offering sometimes minimal benefits. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/if-we-dont-talk-about-value-cancer-drugs-will-become-terminal-for-health-systems-44072">If we don't talk about value, cancer drugs will become terminal for health systems</a>
</strong>
</em>
</p>
<hr>
<p>Extortionate prices were feeding drug company mega-profits, and at the same time driving down the industry’s reputation. In a notorious example, the cost of the life-saving Epipen skyrocketed more than 400%, helping make drug prices <a href="https://www.forbes.com/sites/arleneweintraub/2016/09/01/epipen-only-scratches-the-surface-of-the-drug-price-crisis-jama-study-says/?sh=3d3292d41c7a">a big issue</a> in the 2016 US presidential election. </p>
<figure class="align-center ">
<img alt="Two epipens sit in front of their pack." src="https://images.theconversation.com/files/414246/original/file-20210803-23-1iib9o9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/414246/original/file-20210803-23-1iib9o9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/414246/original/file-20210803-23-1iib9o9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/414246/original/file-20210803-23-1iib9o9.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/414246/original/file-20210803-23-1iib9o9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/414246/original/file-20210803-23-1iib9o9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/414246/original/file-20210803-23-1iib9o9.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">The price of Epipens rose by more than 400%.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/saint-louis-united-states-august-25-473806648">Shutterstock</a></span>
</figcaption>
</figure>
<p>Industry argues high prices fund vital research. Critics say companies can spend more on marketing than research, and their profits sometimes derive from taxpayer-funded science. </p>
<p>To make matters worse, the big pharmaceutical companies are also among the big tax avoiders. A 2015 <a href="https://www.michaelwest.com.au/big-pharma-bosses-front-up-to-senate-inquiry-into-corporate-tax-avoidance/">Senate hearing</a> in Australia heard companies were paying rates as low as one cent in the dollar. </p>
<p>A global <a href="https://www.oxfam.org/en/press-releases/drug-companies-cheating-countries-out-billions-tax-revenues">report from Oxfam</a> in 2018 concluded the pharmaceutical industry was “cheating countries out of billions in tax revenues”. </p>
<h2>Toxic marketing causes harm</h2>
<p>The major problem with the drug giants is their <a href="https://theconversation.com/time-to-end-drug-company-distortion-of-medical-evidence-127495">unhealthy influence</a> over medical science. The industry dominates research, and there’s <a href="https://www.cochrane.org/MR000033/METHOD_industry-sponsorship-and-research-outcome">strong evidence</a> that company-sponsored studies tend to have a bias which favours the sponsor’s product. </p>
<p>Medical education is also heavily sponsored, with evidence suggesting an association between a doctor accepting <a href="https://theconversation.com/drug-companies-are-buying-doctors-for-as-little-as-a-16-meal-61364">just one meal</a> at an “educational event”, and prescribing more of the sponsor’s drugs. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/influential-doctors-arent-disclosing-their-drug-company-ties-110888">Influential doctors aren't disclosing their drug company ties</a>
</strong>
</em>
</p>
<hr>
<p>And the guidelines which can be so influential over a doctor’s prescribing decisions are too often <a href="https://bmjopen.bmj.com/content/9/2/e025864">written by medical experts</a> with ties to drug companies. </p>
<p>Central to this marketing effort are these senior medical experts, sometimes called “<a href="https://www.bmj.com/content/336/7658/1402">key opinion leaders</a>”, who claim to be independent yet accept fees for advice, consultancies or “educational” presentations to other doctors. </p>
<figure class="align-center ">
<img alt="Male doctor types at his computer." src="https://images.theconversation.com/files/414248/original/file-20210803-15-rn30tb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/414248/original/file-20210803-15-rn30tb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/414248/original/file-20210803-15-rn30tb.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/414248/original/file-20210803-15-rn30tb.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/414248/original/file-20210803-15-rn30tb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/414248/original/file-20210803-15-rn30tb.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/414248/original/file-20210803-15-rn30tb.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Just one meal at a sponsored educational event can result in a doctor prescribing more of that company’s drugs.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/doctor-typing-on-his-computer-office-142168426">Shutterstock</a></span>
</figcaption>
</figure>
<p>A former top-selling drug company sales representative turned whistleblower put it plainly in a 2008 piece in <a href="https://www.bmj.com/content/336/7658/1402">The BMJ</a>: </p>
<blockquote>
<p>Key opinion leaders were salespeople for us, and we would routinely measure the return on our investment, by tracking prescriptions before and after their presentations. </p>
<p>If that speaker didn’t make the impact the company was looking for, then you wouldn’t invite them back.</p>
</blockquote>
<p>Unhealthy marketing means the latest most expensive pill is too often favoured over older cheaper options, or doing nothing at all, causing much harm and wasting precious resources. </p>
<h2>Corporate crime</h2>
<p>In 2009 came the biggest health-care fraud settlement in history. Pfizer was forced to fork out a <a href="https://web.archive.org/web/20091212121012/http://www.stopmedicarefraud.gov/index.html">US$2.3 billion fine</a> for illegal promotion, false and misleading claims about drug safety, and paying kickbacks to doctors. That included a US$1.2 billion criminal fine, the largest ever in a US criminal prosecution.</p>
<p>One of the whistleblowers in that case happened to be a <a href="https://www.allenandunwin.com/browse/books/academic-professional/health/Sex-Lies--Pharmaceuticals-Ray-Moynihan-9781742370187">member of a special Pfizer sales team</a> promoting Viagra. He revealed doctors were taken to breakfasts, lunches, dinners, Broadway shows, baseball games, golf courses, ski fields, casinos and strip clubs. </p>
<p>In 2013, Johnson & Johnson paid out US$2.2 billion in civil and criminal fines for putting “<a href="https://www.justice.gov/opa/pr/johnson-johnson-pay-more-22-billion-resolve-criminal-and-civil-investigations">profit over patients’ health</a>”. The company had illegally promoted powerful anti-psychotic drugs as behaviour control for the elderly and most vulnerable, overstating benefits and playing down dangerous side effects, including stroke. </p>
<figure class="align-center ">
<img alt="Older man holds pill to his mouth in one hand and a glass of water in the other." src="https://images.theconversation.com/files/414247/original/file-20210803-23-13hydnm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/414247/original/file-20210803-23-13hydnm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/414247/original/file-20210803-23-13hydnm.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/414247/original/file-20210803-23-13hydnm.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/414247/original/file-20210803-23-13hydnm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/414247/original/file-20210803-23-13hydnm.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/414247/original/file-20210803-23-13hydnm.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Drug companies have faced massive fines for putting profits over health.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/asian-old-man-taking-pill-another-1679120026">Shutterstock</a></span>
</figcaption>
</figure>
<p>Other court documents around the same time exposed how the giant global company Merck used <a href="https://www.bmj.com/content/338/bmj.b1914.extract">dirty tricks</a> to try and defend its controversial anti-arthritis drug Vioxx. Merck created a fake medical journal and drew up secret lists of academic critics to “neutralise” and “discredit”. </p>
<p>In the end, Vioxx was taken off the market because it was causing heart attacks, with estimates in <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(05)17864-7/fulltext">The Lancet</a> suggesting it may have led to 140,000 cases of serious coronary heart disease.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/the-most-powerful-companies-youve-never-heard-of-merck-3187">The most powerful companies you've never heard of: Merck</a>
</strong>
</em>
</p>
<hr>
<h2>Investigation and reform</h2>
<p>Scandals like Vioxx tarnished the industry’s image, and brought more intense scrutiny. </p>
<p>The US National Academy of Sciences produced a <a href="https://www.ncbi.nlm.nih.gov/books/NBK22942/">landmark report</a> arguing the closeness between doctors and drug companies could jeopardise the integrity of science, the objectivity of education, the quality of care, and public trust in medicine. </p>
<p>A series of US congressional hearings on unhealthy marketing produced the <a href="https://openpaymentsdata.cms.gov/">Open Payments</a> register, mandated by US law to publicly list every company payment to every doctor. </p>
<p>Many around the world are <a href="https://www.bmj.com/content/367/bmj.l6576">reforming further</a>, moving from transparency to independence. Italy brought in a <a href="https://pubmed.ncbi.nlm.nih.gov/20055898/">special tax</a> on drug company promotion to fund public interest research. Norway doesn’t give doctors full credit anymore for <a href="https://www.legeforeningen.no/om-oss/Styrende-dokumenter/legeforeningens-lover-og-andre-organisatoriske-regler/avtale-mellom-legemiddelindustriforeningen-og-den-norske-lageforening-om-retningslinjer-for-samarbeid-og-samhandling-mellom-leger-legeforeningen-og-legemiddelindustrien/#23800">industry-sponsored</a> education. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/guidelines-governing-canadian-doctors-relationships-with-pharma-companies-under-review-149519">Guidelines governing Canadian doctors' relationships with pharma companies under review</a>
</strong>
</em>
</p>
<hr>
<p>But there’s a long way to go. A <a href="https://www.bmj.com/content/369/bmj.m1505">study</a> in 2020 found 80% of the medicos who run the world’s most powerful doctors organisations still take money from drug and device companies. For research, for consultancies, for hospitality. </p>
<p>Even some agencies which assess drugs, notably the <a href="https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance">US Food and Drug Administration</a> (FDA), still rely on significant funding from industry, which pays to have its products assessed. </p>
<p>And the harmful marketing has continued. Just last month, a group of drug companies, including Johnson & Johnson, <a href="https://www.theguardian.com/us-news/2021/jul/21/us-opioid-settlement-state-attorneys-general-johnson-and-johnson">agreed to pay</a> a total of US$26 billion for their roles in fuelling the opioid epidemic. </p>
<h2>A prescription for trust</h2>
<p>One drug company chief <a href="https://www.fiercepharma.com/pharma/amid-challenges-a-covid-19-opportunity-for-pharma-a-chance-to-bolster-its-reputation-lilly">reportedly said</a> last year the industry had a “once-in-a-generation opportunity to reset” its reputation. </p>
<p>Given the dark arts that drove pharma’s credibility to rock bottom, its fanciful to imagine the pandemic will magically end the misleading marketing and the price gouging.</p>
<p>Any post-pandemic recovery requires meaningful reform. </p>
<hr>
<p><em>This article is part of a global Conversation series, <a href="https://theconversation.com/au/topics/the-business-of-pharmaceuticals-108206">The business of pharmaceuticals</a>. You can read the other articles <a href="https://theconversation.com/au/topics/the-business-of-pharmaceuticals-108206">here</a>.</em></p><img src="https://counter.theconversation.com/content/165082/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ray Moynihan is Assistant Professor at Bond University's Institute for Evidence-Based Healthcare and Adjunct Associate Professor at the University of Sydney. He receives funding via competitive grants from Australia's publicly funded National Health and Medical Research Council. Ray has written about and researched the pharmaceutical industry's influence for almost 25 years and is the author of 4 books on the business of medicine. </span></em></p>The COVID pandemic is giving drug companies an opportunity to reset their image. So how did they get so big and their credibility sink so low?Ray Moynihan, Assistant Professor, Bond UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1629752021-07-14T12:57:07Z2021-07-14T12:57:07ZBig Pharma’s COVID-19 reputation boost may not last — here’s why<figure><img src="https://images.theconversation.com/files/411053/original/file-20210713-23-q0rjjq.JPG?ixlib=rb-1.1.0&rect=0%2C56%2C4165%2C2687&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The first Pfizer-BioNTech COVID-19 vaccine dose in Canada sits ready for use at The Michener Institute in Toronto in mid-December 2020, less than a year from when the World Health Organization declared COVID-19 a pandemic.</span> <span class="attribution"><span class="source">THE CANADIAN PRESS/Frank Gunn </span></span></figcaption></figure><p>The race for developing effective COVID-19 vaccines has <a href="https://fortune.com/longform/covid-vaccine-big-pharma-drugmakers-coronavirus-pharmaceutical-industry/">put the pharmaceutical industry in the spotlight</a>. </p>
<p>Over the past few months, the world has witnessed rapid clinical trials and approvals of several highly effective vaccines like Pfizer, Moderna and AstraZeneca. This unprecedented achievement has been made possible by <a href="https://doi.org/10.1038/s41587-021-00912-9">close intra-industry, state industry and international collaborations</a>. </p>
<p>Big Pharma’s proactive approach to vaccine development has also brought an unexpected consequence: its reputation has been notably enhanced since early 2020. A survey conducted in February 2021 found that <a href="https://www.fiercepharma.com/marketing/pharma-reputation-hits-high-americans-two-thirds-now-give-positive-rating-harris-poll">almost two-thirds of Americans now give the pharmaceutical industry high marks</a>.</p>
<p><a href="https://www.ft.com/content/7ad9d74e-f4e7-4b30-9391-0b934662b6ac">But reputation risks loom</a> even as pharma companies are being celebrated as pandemic heroes. </p>
<p>The controversy over the AstraZeneca vaccine’s potential serious side-effects is a prime example. The English company has experienced a public backlash <a href="https://www.theguardian.com/business/2021/mar/26/how-the-astrazeneca-vaccine-became-a-political-football-and-a-pr-disaster">due to a lack of a crisis response plan and conflicting messages delivered by different stakeholders</a>. </p>
<figure class="align-center ">
<img alt="AstraZeneca sign on the side of a building." src="https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=329&fit=crop&dpr=1 600w, https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=329&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=329&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=414&fit=crop&dpr=1 754w, https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=414&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=414&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">The global headquarters of AstraZeneca in London.</span>
<span class="attribution"><span class="source">(AP Photo/Kirsty Wigglesworth)</span></span>
</figcaption>
</figure>
<p>Will the reputation boost enable the pharmaceutical industry to fundamentally rebuild its negative public image? As someone who researches public relations, I believe that only by prioritizing socially responsible practices can Big Pharma achieve true reputation redemption. </p>
<h2>Big Pharma’s damaged reputation</h2>
<p>Prior to the COVID-19 pandemic, the pharmaceutical industry had been battling reputational damage for years. Notably, <a href="https://news.gallup.com/poll/266060/big-pharma-sinks-bottom-industry-rankings.aspx">it sank to the bottom of Gallup’s August 2019 United States industry favourability poll</a>, with a total positive score of only 27 per cent. According to Gallup’s analysis, high drug costs, massive advertising and lobbying spending and the opioid crisis have all tarnished the industry’s public image. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/oxycontin-how-purdue-pharma-helped-spark-the-opioid-epidemic-57331">Oxycontin: how Purdue Pharma helped spark the opioid epidemic</a>
</strong>
</em>
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<p>This is consistent with public relations research conducted in Europe. In <a href="https://doi.org/10.1177/2046147X18774588">a qualitative analysis published by <em>Public Relations Inquiry</em></a>, a team of Ghent University researchers analyzed how Belgian pharma companies responded to the pervasive “Bad Pharma” public image. </p>
<p>Their analysis revealed that Bad Pharma perceptions reflected larger societal issues, including widening income and health gaps. The public expects the pharmaceutical industry to save and improve lives by developing innovative, affordable and effective medicines. Accordingly, the industry loses trust when the public believes its actions and motives are at odds with those expectations. Such a decline in public trust can’t be easily fixed by corporate responsibility reports or public relations campaigns.</p>
<p>The pharmaceutical industry’s reputational challenges also correlate to how the media covers it. A <a href="https://doi.org/10.1007/s43441-019-00048-8">2020 analysis of Big Pharma-related coverage</a> found that the majority of stories were neutral and involved reporting on topics like finances, stocks, profits, mergers, acquisitions and restructuring. Coverage is more negative when it delves, less often, into more sentimental topics. </p>
<p>In other words, the media mostly reports on Big Pharma from a business perspective instead of from a social and public health perspective. This lack of media attention to the industry’s social responsibilities contributes to growing public distrust of it in recent years.</p>
<figure class="align-center ">
<img alt="A man holds a sign that reads Drug Users Deserve Health Care with Heart." src="https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=397&fit=crop&dpr=1 600w, https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=397&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=397&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=498&fit=crop&dpr=1 754w, https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=498&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=498&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A man holds a sign in Vancouver in 2017 during a march on the first National Day of Action to draw attention to the opioid overdose epidemic.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Darryl Dyck</span></span>
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<h2>Risks underlie vaccine-led reputation boost</h2>
<p>Considering the above factors, it’s unsurprising that the pharmaceutical industry’s all-hands-on-deck efforts on COVID-19 vaccines, in combination with extensive media coverage, has resulted in <a href="https://www.vox.com/policy-and-politics/2021/4/2/22362078/covid-19-vaccines-pfizer-pharma-companies-popularity">a substantial improvement in public sentiment</a>. According to <a href="https://www.filesforprogress.org/datasets/2021/3/dfp-pharma-infrastructure-funding.pdf">a survey conducted by think tank Data for Progress in March 2021</a>, 56 per cent of respondents had a favourable view of pharmaceutical companies, double the rating of Gallup’s 2019 poll. </p>
<p>Nonetheless, a closer look at the data reveals two caveats. </p>
<p>First, drug costs remain the top concern for the public. The Data for Progress survey suggests that 72 per cent of American voters support policy measures that would lower the cost of prescription drugs. The pharma industry, meantime, insists that the discounted prices it’s currently offering for COVID-19 vaccines will not last very long. </p>
<h2>Vaccine prices to rise?</h2>
<p>In February, Pfizer CFO Frank D'Amelio said in <a href="https://www.biopharmadive.com/news/coronavirus-vaccines-pricing-questions-moderna-pfizer/594762/">a call with Wall Street analysts</a> that after the pandemic, Pfizer is “going to get more on price” and hinted there would be a substantial price increase for its COVID-19 vaccine. </p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Two men sit in front of a Pfizer sign." src="https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=410&fit=crop&dpr=1 600w, https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=410&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=410&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=516&fit=crop&dpr=1 754w, https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=516&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=516&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Pfizer Canada executives hold a news conference in Montréal in 2012.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Graham Hughes</span></span>
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<p>The company currently charges US$19.50 per dose for its vaccine, but the typical price is $150 to $175 per dose for other vaccines it sells. If implemented, this aggressive pricing policy would undoubtedly result in public criticism, especially from developing countries that have already been neglected during the first round of global vaccine allocation.</p>
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Read more:
<a href="https://theconversation.com/global-herd-immunity-remains-out-of-reach-because-of-inequitable-vaccine-distribution-99-of-people-in-poor-countries-are-unvaccinated-162040">Global herd immunity remains out of reach because of inequitable vaccine distribution – 99% of people in poor countries are unvaccinated</a>
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<p>Second, the remarkable speed of research and innovation achieved during COVID-19 vaccine development is mainly due to intensive government funding support and concerted collaborations across multiple sectors. It’s uncertain whether these special measures herald the arrival of a new model in which governments have better regulation over Big Pharma issues like patent control, advertising, clinical data transparency and spending on lobbying.</p>
<p>If the pharmaceutical industry wants to achieve the ultimate image makeover, it must capitalize on the current goodwill by prioritizing socially responsible practices. That begins with fairer drug pricing and a genuine commitment to resolving public health disparities.</p><img src="https://counter.theconversation.com/content/162975/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Sibo Chen receives funding from Ryerson University and the Social Sciences and Humanities Research Council of Canada. </span></em></p>If Big Pharma wants to achieve the ultimate image makeover, it must capitalize on the current public good will about its COVID-19 vaccines by prioritizing socially responsible practices.Sibo Chen, Assistant Professor, School of Professional Communication, Toronto Metropolitan UniversityLicensed as Creative Commons – attribution, no derivatives.