tag:theconversation.com,2011:/au/topics/drug-companies-19661/articlesDrug companies – 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/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>
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<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">
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<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>
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<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>
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<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>
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<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>
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<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>
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<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>
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<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">
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<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>
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<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>
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<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/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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<p>
<em>
<strong>
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>
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<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>
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<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/1396032020-05-31T17:14:20Z2020-05-31T17:14:20ZRecent drug shortages in Europe overshadow half a century of trade surpluses<p>The Covid-19 shock led to shortages in essential drugs in many European countries, including France. Such insufficiencies <a href="http://www.senat.fr/rap/r17-737/r17-7371.pdf">are not new</a> in the global pharmaceutical market, which is clearly dominated by advanced countries, and particularly those in Europe. China’s and India’s pharmaceutical-trade shares continue to overall only be modest, although they have been rising over time, and have become central for some products.</p>
<p>This advanced-country predominance has held for over half a century, as can be seen in the <a href="http://www.cepii.fr/CEPII/en/bdd_modele/presentation.asp?id=17">CHELEM</a> database, which lists the values of bilateral trade flows in current US dollars for 71 product categories, going back to 1967. The “GF” product category here includes basic pharmaceutical products pertaining to organic chemistry (alkaloids, antibiotics, hormones, vitamins and so on) and pharmaceutical preparations (medicines, blood, vaccines etc.).</p>
<h2>The breakthrough of Ireland and Belgium</h2>
<p>Pharmaceuticals has been one of the most dynamic industries in terms of international-trade growth. Between 1967 and 2018, annual trade flows rose by an average of 11.7% at current prices (as compared to a figure of 9% p.a. for all goods). This growth rate is similar to that of electrical components (14% p.a.) and telecommunications equipment (12.4%). The share of pharmaceutical goods in international trade increased sharply from 1% in 1989 to 2.8% in 2003, and was 3.3% in 2018.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/338288/original/file-20200528-51516-jt43zx.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/338288/original/file-20200528-51516-jt43zx.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=352&fit=crop&dpr=1 600w, https://images.theconversation.com/files/338288/original/file-20200528-51516-jt43zx.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=352&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/338288/original/file-20200528-51516-jt43zx.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=352&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/338288/original/file-20200528-51516-jt43zx.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=442&fit=crop&dpr=1 754w, https://images.theconversation.com/files/338288/original/file-20200528-51516-jt43zx.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=442&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/338288/original/file-20200528-51516-jt43zx.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=442&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Figure 1: Pharmaceuticals versus electronic products. Shares of world trade in goods (%).</span>
<span class="attribution"><a class="source" href="https://db.nomics.world/CEPII/CHELEM-TRADE-CHEL">CEPII, CHELEM-International trade database</a>, <span class="license">Author provided</span></span>
</figcaption>
</figure>
<p>Since 1967, the share of pharmaceutical exports originating from advanced countries has hovered around 90%, with the EU-28 accounting for between 62% and 72% of world exports, and Germany, France, the United Kingdom, the Netherlands and Italy being significant exporters over the entire period (Figure 2, exports).</p>
<p>The shares of Ireland and Belgium in this trade skyrocketed in the 2000s. By 2018, Ireland was the third-largest exporter of pharmaceutical products (accounting for 9.1% of world exports), ranking just behind Germany (15%) and Switzerland (12%), but ahead of the United States (8.7%), itself followed closely by Belgium (7.8%). The sharp increase in Belgium’s share in world imports in 2002 can be entirely attributed to purchases from Ireland (Figure 2, imports).</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/338289/original/file-20200528-51477-a7yqh0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/338289/original/file-20200528-51477-a7yqh0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/338289/original/file-20200528-51477-a7yqh0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=332&fit=crop&dpr=1 600w, https://images.theconversation.com/files/338289/original/file-20200528-51477-a7yqh0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=332&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/338289/original/file-20200528-51477-a7yqh0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=332&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/338289/original/file-20200528-51477-a7yqh0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=417&fit=crop&dpr=1 754w, https://images.theconversation.com/files/338289/original/file-20200528-51477-a7yqh0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=417&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/338289/original/file-20200528-51477-a7yqh0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=417&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Figure 2: The share of advanced countries in world pharmaceutical trade (%). Notes: Advanced countries are defined according to the IMF (WEO, April 2020). Only those with a share of over four per cent of world trade are depicted individually here.</span>
<span class="attribution"><a class="source" href="https://db.nomics.world/CEPII/CHELEM-TRADE-CHEL">CEPII, CHELEM-International trade database</a>, <span class="license">Author provided</span></span>
</figcaption>
</figure>
<p>The spectacular rise of these two small EU member states with attractive tax systems owes much to the location decisions of multinational firms. These firms established <a href="https://www.plan.be/uploaded/documents/201905091117590.WP_1905_11895.pdf">affiliates in these countries</a>, boosting local production and creating an intricate network of trade links across the Atlantic. Belgium has turned into a platform for the re-export of pharmaceutical products to not only the United States but also its European partners (mostly Germany). As for Ireland, its remarkable surplus hides sharp asymmetric movements in its European exports (mainly to Belgium, Germany and the United Kingdom): as exports to one country rise, they fall by the same amount to other European countries. The overall trend in Ireland is of a falling surplus toward Europe, matched by a rising surplus toward the United States (with figures of 4% of the world trade in pharmaceutical products in 2018 with each of these two trade partners).</p>
<p>In 2018, Belgium was the United States’ main customer (accounting for one tenth of US exports) while Ireland was the US’s main supplier (furnishing over 20% of US imports). The fiscal and industrial strategies of multinational companies within the US/Ireland/Belgium triangle inflate the share of the European Union in the global trade in pharmaceutical products.</p>
<h2>The rise of emerging economies</h2>
<p>Advanced countries have substantially increased their share of world imports: from 56% in 1967 to 76% in 2018 (See Figure 2). The United States on its own accounts for three-quarters of this 20 percentage-point rise. The European Union’s share in world imports, although below its share in world exports, remained at over 40% throughout the period (peaking at 57% in 2004).</p>
<p>India and China are the only emerging countries to play a significant role in the pharmaceutical trade (Figure 3), with shares that have been rising steadily since the mid-2000s. In 2018, India and China each accounted for 3% of global exports. China exports mainly to the European Union (14% of its sales), and then to India and the United States (9% each). India primarily sells to the United States (17%), and then to Africa (11%) and the European Union (7%).</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/338290/original/file-20200528-51467-1tqx7nj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/338290/original/file-20200528-51467-1tqx7nj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=344&fit=crop&dpr=1 600w, https://images.theconversation.com/files/338290/original/file-20200528-51467-1tqx7nj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=344&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/338290/original/file-20200528-51467-1tqx7nj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=344&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/338290/original/file-20200528-51467-1tqx7nj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=432&fit=crop&dpr=1 754w, https://images.theconversation.com/files/338290/original/file-20200528-51467-1tqx7nj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=432&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/338290/original/file-20200528-51467-1tqx7nj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=432&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Figure 3: The share of India and China in world pharmaceutical trade (%).</span>
<span class="attribution"><a class="source" href="https://db.nomics.world/CEPII/CHELEM-TRADE-CHEL">CEPII, CHELEM-International trade database</a>, <span class="license">Author provided</span></span>
</figcaption>
</figure>
<p>India’s small share of world imports has not varied much over the last 50 years – it was just 0.6% in 2018 (Figure 3, imports, above). However, its main import partner, which was previously Europe and the Commonwealth of Independent States (CIS) region, is now China, up from less than 1% of its purchases in 1979 to over 40% in 2018.</p>
<p>On the contrary, Chinese imports have been rising since 2005, especially since the Great Recession and the <a href="https://onlinelibrary.wiley.com/doi/abs/10.1111/cwe.12191">rebalancing of its growth</a> toward domestic demand. The <a href="https://theconversation.com/covid-19-lheure-de-verite-pour-le-systeme-de-sante-chinois-111928">reform of China’s healthcare system</a> has also played a role. Most Chinese pharmaceutical imports come from Europe (20% in 2018), far ahead of imports from the United States (6%).</p>
<h2>The international fragmentation of production</h2>
<p>The map of international pharmaceutical trade confirms the central position of Europe: in 2018, 46% of world trade in pharmaceuticals took place in the “Europe & CIS” region (39% originating from the EU, 6% from other European countries, and 1% from the CIS), while the figure for the intra-European share of all goods in world trade is only 29%. Europe also takes the lion’s share of inter-regional flows, mostly with the Americas (with this latter flow corresponding to 18% of world pharmaceutical trade) and then Asia & Oceania (9%). Less than one quarter of pharmaceutical trade originates from the rest of the world, with a figure for Asia & Oceania of barely 11% (as compared to their figure of 35% for aggregate trade).</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/338291/original/file-20200528-51516-1hlkvdg.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/338291/original/file-20200528-51516-1hlkvdg.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=392&fit=crop&dpr=1 600w, https://images.theconversation.com/files/338291/original/file-20200528-51516-1hlkvdg.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=392&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/338291/original/file-20200528-51516-1hlkvdg.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=392&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/338291/original/file-20200528-51516-1hlkvdg.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=492&fit=crop&dpr=1 754w, https://images.theconversation.com/files/338291/original/file-20200528-51516-1hlkvdg.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=492&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/338291/original/file-20200528-51516-1hlkvdg.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=492&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Map: The intra- and inter-regional pharmaceutical-trade. Share in world pharmaceutical trade in 2018 (%). Notes: The table displays the sum of intra- and inter-regional flows shown on the map for each region. The sum of exports from Europe & CIS to the Americas (18%), Asia & Oceania (8.9%), Africa & the Middle East (3.6%) and intra-European trade (46.1) together accounts for 76.6% of world exports.</span>
<span class="attribution"><span class="license">Author provided</span></span>
</figcaption>
</figure>
<p>For over half a century, advanced countries have been running massive trade surpluses with respect to the rest of the world in the pharmaceutical sector. In 2018, their trade surplus was still 13% of the world trade in pharmaceutical goods, despite having dropped markedly between the late 1960s and early 2000s (Figure 4).</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/338292/original/file-20200528-51456-c5gp67.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/338292/original/file-20200528-51456-c5gp67.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=332&fit=crop&dpr=1 600w, https://images.theconversation.com/files/338292/original/file-20200528-51456-c5gp67.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=332&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/338292/original/file-20200528-51456-c5gp67.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=332&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/338292/original/file-20200528-51456-c5gp67.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=417&fit=crop&dpr=1 754w, https://images.theconversation.com/files/338292/original/file-20200528-51456-c5gp67.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=417&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/338292/original/file-20200528-51456-c5gp67.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=417&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Figure 4: Market positions in world pharmaceutical trade (trade balance as a% of world pharmaceutical trade). Note: Advanced countries are defined according to the IMF (WEO, April 2020).</span>
<span class="attribution"><a class="source" href="https://db.nomics.world/CEPII/CHELEM-TRADE-CHEL">CEPII, CHELEM-International Trade database</a>, <span class="license">Author provided</span></span>
</figcaption>
</figure>
<p>Among advanced countries, the experiences of the United States and Europe have diverged since the Great Recession: the trade balance worsened for the United States to reach a 9% deficit in 2018, while the fall in the European surplus has stopped, with a surplus figure that is now 25% of the world trade in pharmaceutical goods. The mirror image of the worsening of the US balance has been growing surpluses in Ireland, Switzerland and Germany vis-à-vis the United States.</p>
<p>Among the emerging countries, India’s surplus has been rising steadily, but remains relatively small (2% in 2018), while China’s trade balance has turned slightly negative with its rising imports (Figure 4).</p>
<p>Despite its substantial surplus (one quarter of world trade in pharmaceutical goods), Europe has in recent years faced growing <a href="https://www.ema.europa.eu/en/documents/other/reflection-paper-medicinal-product-supply-shortages-caused-manufacturing/good-manufacturing-practice-compliance-problems_en.pdf">supply difficulties</a>, in part linked to the <a href="https://theconversation.com/apres-le-choc-relocalisations-dans-lindustrie-delocalisations-dans-les-services-135589">international fragmentation</a> of production, the concentration of pharmaceutical firms, and the just-in-time inventory-management strategies of multinationals.</p>
<p>The sector is characterised by a high level of R&D investment; most innovative products are expensive, and margins remain high as long as the products are covered by patents. However, the low-cost production of generic drugs and active ingredients is being <a href="https://theconversation.com/medicaments-a-quelles-conditions-pourra-t-on-relocaliser-la-production-des-principes-actifs-135643">offshored</a> to India and China. The Covid-19 pandemic and the shortages of some key medicinal products have revealed the weaknesses of the Old Continent, portraying Europe as a giant with feet of clay.</p><img src="https://counter.theconversation.com/content/139603/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Les auteurs ne travaillent pas, ne conseillent pas, ne possèdent pas de parts, ne reçoivent pas de fonds d'une organisation qui pourrait tirer profit de cet article, et n'ont déclaré aucune autre affiliation que leur organisme de recherche.</span></em></p>The Covid-19 pandemic has laid bare Europe’s vulnerability to drug-supply disruption. Still, it remains by far the world leader in pharmaceutical products.Deniz Unal, Économiste, CEPII - Recherche et expertise sur l'économie mondiale, CEPIIAude Sztulman, Maître de conférences, Université Paris Dauphine – PSLGuillaume Gaulier, Chercheur associé, CEPIIPierre Cotterlaz, Économiste, CEPIILicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1268782020-02-07T12:04:52Z2020-02-07T12:04:52ZDo drugs go off? What happens to medicines after their use-by dates<figure><img src="https://images.theconversation.com/files/312837/original/file-20200130-41495-nehn0b.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://www.shutterstock.com/image-photo/drug-prescription-treatment-medication-pharmaceutical-medicament-769176202">Shutterstock/BukhtaYurii</a></span></figcaption></figure><p>It is estimated that there is <a href="http://www.medicinewaste.com/help">a staggering £300m</a> worth of medicine unused in the UK every year. But is it safe to take these medicines if they are past their expiry date? </p>
<p>Expiry dates are put in place after rigorous trialling and controlled experiments to ensure the safety and effectiveness of the drugs people take. In short, they guarantee the potency of the drug. Medicinal drugs are all chemicals and the rate at which they go off will depend upon their chemical structure, the drug preparation, how they are packaged, environmental conditions, whether they are subject to microbial contamination and their exposure to heat, light, oxygen and water.</p>
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Read more:
<a href="https://theconversation.com/medicine-shortages-are-already-a-reality-but-a-no-deal-brexit-could-make-it-worse-102218">Medicine shortages are already a reality but a no deal Brexit could make it worse</a>
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<p>The drugs are sold in a variety of containers including bottles, blister packs, tubes and ampules. They are relatively secure while sealed. But once the seal is broken, the process of “going off” accelerates.</p>
<h2>Common painkillers</h2>
<p>Let’s look at an everyday drug like <a href="https://theconversation.com/whats-the-point-of-paracetamol-66808">paracetamol</a>. This is an “over the counter” medicine, freely available, which helps to reduce pain or a fever. Paracetamol is sometimes sold in brown sealed bottles. The seal keeps moisture and atmospheric oxygen out. The brown bottle keeps UV light out as this can also cause the drug to breakdown. Once the seal is broken, the tablets are exposed to water and oxygen in the air and breakdown begins.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/312839/original/file-20200130-41503-8kbscj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/312839/original/file-20200130-41503-8kbscj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=480&fit=crop&dpr=1 600w, https://images.theconversation.com/files/312839/original/file-20200130-41503-8kbscj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=480&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/312839/original/file-20200130-41503-8kbscj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=480&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/312839/original/file-20200130-41503-8kbscj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=603&fit=crop&dpr=1 754w, https://images.theconversation.com/files/312839/original/file-20200130-41503-8kbscj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=603&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/312839/original/file-20200130-41503-8kbscj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=603&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Paracetamol comes in bottles and blister packs and can be bought over the counter.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-illustration/3d-rendering-paracetamol-pills-on-blister-765786244">Shutterstock/AleksandraGigowska</a></span>
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<p>Paracetamol is also sold in blister packs. These packs are permeable to water and oxygen so they are covered in, for example, polyvinylidene chloride (PVDC). This protects the contents and slows down the decomposition process but is still slightly permeable so doesn’t prevent it altogether.</p>
<p>The consequence of this is that, despite the protection of the packaging, the drug content slowly declines. <a href="https://mfprac.com/web2019/07literature/literature/Misc/ExpirationDates_ed.pdf">Research shows</a> that when paracetomol based medicines go past their expiry date, up to 30% of the drug may break down in between 12 and 24 months.</p>
<h2>Cold remedies and antibiotics</h2>
<p>Cold remedies contain both paracetamol and a decongestant (usually phenylephrine hydrochloride). These can be sold as powders, capsules, oral solutions or nasal sprays.</p>
<p>While drugs in dry powder and capsule form may be relatively stable, those in liquid form may go off more quickly. For example, cold remedies such as nasal sprays contain both preservatives and antioxidants that only work at lower temperatures. They are considerably less effective above 40°C. </p>
<p>Similarly, antibiotics such as amoxicillin and erythromycin can be prescribed as an oral suspension in water. The dry powder form of the drug is, again, relatively stable. But the shelf life of the drug mixed with water by the pharmacist may only be seven to ten days – even when kept in a fridge.</p>
<p>Some drugs in liquid form have a considerably shorter shelf life. For example, nitroglycerin (glyceryltrinitrate) is used to treat angina and coronary heart disease. Formulations include liquids, tablets and capsules. Nitrate esters, of which this drug is an example, readily break down in the presence of water, rendering the drug ineffective.</p>
<p>Some formulations of nitroglycerin contain stabilisers to reduce this and are contained in protective packaging. But even these formulations only have a shelf life of about three months. Users often divide up their doses into pill boxes. The shelf life of nitroglycerin, once out of protective packaging, is reduced down to less than a week because of the rapid rate of drug breakdown.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/312840/original/file-20200130-41527-1xb3ipj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/312840/original/file-20200130-41527-1xb3ipj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=401&fit=crop&dpr=1 600w, https://images.theconversation.com/files/312840/original/file-20200130-41527-1xb3ipj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=401&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/312840/original/file-20200130-41527-1xb3ipj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=401&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/312840/original/file-20200130-41527-1xb3ipj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/312840/original/file-20200130-41527-1xb3ipj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/312840/original/file-20200130-41527-1xb3ipj.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">Taking pills out of their packs and putting them in boxes can reduce their shelf life.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/elderly-man-counts-out-his-pills-354226556">Shutterstock/JeffBaumgart</a></span>
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<p>Even large, macromolecular drugs, like insulin, present problems. Insulin is a polypeptide used in the maintenance of blood glucose levels and the management of diabetes. </p>
<p>The drug is dissolved in water and when stored in a refrigerator (typically around 4°C) spoiling can be slowed. The solutions also contain preservatives to reduce the rate of spoiling. However, as they are small proteins, the drug molecules may break down in water, and in some instances bacteria can start to grow and break down the protein. This is why the shelf life of drugs such as insulin is very limited.</p>
<h2>Safety</h2>
<p>So is it safe to take medicines after their expiration date? The answer depends on the drug in question but, generally, no. Drugs like nitroglycerin may, in some instances, be life saving. But the actual drug content of out-of-date medicines such as this may mean that there is no effective medicine left in what is being taken. So there will be no effect on the target condition. </p>
<p>In the case of liquid antibiotics the concentration of the drug may be so reduced that it is not effective. To make things worse, <a href="https://www.sciencedaily.com/releases/2018/04/180423085415.htm">studies have shown</a> that the bacteria the antibiotic is being used to treat may, at lower concentrations of the drug, develop resistance that could render the antibiotic ineffective.</p>
<p>In other cases, like paracetamol, the consequences may not be so severe. But the drug content won’t be known. So if in doubt, check with pharmacists and doctors and try your best to keep drugs in date.</p><img src="https://counter.theconversation.com/content/126878/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Michael Cole has received funding from the EPSRC, EU (Framework V), EU AGIS programme, Botswanan Government and South African Police Service for carrying out research on the analysis and profiling of controlled substances, including those which contain over the counter medicines.</span></em></p>An estimated £300m worth of medicine goes unused in the UK every year. But is it safe to take drugs past their expiry date?Michael Cole, Professor of Forensic Science, Anglia Ruskin UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1209652019-08-12T22:24:26Z2019-08-12T22:24:26ZHealth Canada and Big Pharma: Too close for comfort<figure><img src="https://images.theconversation.com/files/287170/original/file-20190807-144838-bg0a6t.jpg?ixlib=rb-1.1.0&rect=139%2C253%2C5062%2C3243&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">When drug companies and drug regulators, such as Health Canada, sit down together at "pre-submission meetings" this may have a negative impact on public health. </span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>Over the past few decades it’s become common practice for drug companies and drug regulators, such as Health Canada, to sit down together at what are called pre-submission meetings. </p>
<p>These are get-togethers where both parties talk about an upcoming application from the company. Health Canada’s <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions/industry.html">Guidance for Industry</a> on the management of drug submissions lays out some of the goals: familiarizing Health Canada’s review staff with a submission prior to its arrival, uncovering any major unresolved problems, identifying whether submitted studies are adequate, allowing Health Canada to redistribute funding if necessary.</p>
<p>These types of meetings sound benign or maybe actually positive. Health Canada gets to use its limited resources in the most productive way, the drug company doesn’t have to do extra unnecessary testing and, most importantly, new drugs may reach patients faster. </p>
<p>Moreover, if clinical trials of a new drug in humans are optimized, fewer people will be exposed to unknown risks. If trials are smaller and faster, they will be less expensive and that may mean lower drug prices.</p>
<p>But there are also potential downsides. </p>
<h2>More drug safety problems</h2>
<p>First, it’s Health Canada’s job to protect public health, not to make it less costly for companies to run trials. And the two are not necessarily synonymous. Less expensive trials are typically smaller trials, but fewer patients also means it’s harder to spot rarer side effects before drugs hit the market. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/287171/original/file-20190807-144868-1f38a2h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/287171/original/file-20190807-144868-1f38a2h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=414&fit=crop&dpr=1 600w, https://images.theconversation.com/files/287171/original/file-20190807-144868-1f38a2h.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=414&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/287171/original/file-20190807-144868-1f38a2h.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=414&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/287171/original/file-20190807-144868-1f38a2h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=520&fit=crop&dpr=1 754w, https://images.theconversation.com/files/287171/original/file-20190807-144868-1f38a2h.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=520&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/287171/original/file-20190807-144868-1f38a2h.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=520&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Clinical trials are essential to the development of new and effective medications.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Getting through the regulatory system faster is also cheaper for drug companies, but speedier reviews equate to <a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1377415">more safety problems</a> once drugs are being sold. We also need to remember that in most cases Health Canada doesn’t need to rush new drugs to the market. <a href="http://dx.doi.org/10.1136/bmjopen-2018-023605">Only about one in 10</a> offer a significant improvement over what’s already available.</p>
<p>The idea that the price of drugs is a reflection of how much companies spend on research and development has been <a href="https://www.theatlantic.com/health/archive/2019/03/drug-prices-high-cost-research-and-development/585253/">debunked by the likes of Hank McKinnell, the former CEO of Pfizer</a>.</p>
<p>Finally, if Health Canada is giving drug companies advice about how to run their trials, then will the agency feel obliged to approve those trials once they are submitted, even if they don’t convincingly show a drug to be safe and effective? </p>
<p>As an analogy, suppose a judge meets with the prosecutor before a trial starts, to discuss with the prosecutor how best to present her case. As the defendant, how confident would you be that the judge will be objective in coming to a decision? </p>
<p>In the case of Health Canada and the pharmaceutical industry, the defendant is the Canadian public.</p>
<h2>A revolving door</h2>
<p>These pre-submission meetings occur alongside other ongoing relationships between drug companies and drug regulators. Health Canada already gets 50 per cent of the cost of operating its prescription drug program from money that companies are obliged to pay and it wants that to <a href="https://www.canada.ca/en/health-canada/programs/consultations-revised-fee-proposal-drugs-medical-device/document.html">go up to 75 per cent</a>. </p>
<p>Regulators in other countries recover upwards of 90 per cent of their costs from companies. Although not that visible a problem here in Canada, in the United States there is a revolving door between the Food and Drug Administration and the drug industry. After <a href="https://www.statnews.com/pharmalot/2019/06/27/scott-gottlieb-pfizer-board-fda/">Dr. Scott Gottlieb</a> resigned as FDA commissioner his next move was to the board of Pfizer.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/287169/original/file-20190807-144878-5h6v58.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/287169/original/file-20190807-144878-5h6v58.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=430&fit=crop&dpr=1 600w, https://images.theconversation.com/files/287169/original/file-20190807-144878-5h6v58.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=430&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/287169/original/file-20190807-144878-5h6v58.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=430&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/287169/original/file-20190807-144878-5h6v58.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=540&fit=crop&dpr=1 754w, https://images.theconversation.com/files/287169/original/file-20190807-144878-5h6v58.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=540&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/287169/original/file-20190807-144878-5h6v58.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=540&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Dr. Scott Gottlieb, former U.S. Food and Drug Administration Commissioner.</span>
<span class="attribution"><span class="source">AP Photo/J. Scott Applewhite</span></span>
</figcaption>
</figure>
<p>This type of relationship has garnered criticism in multiple different countries. When a British House of Commons Committee looked into the influence of the pharmaceutical industry on that country’s drug regulator, <a href="https://publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf">it concluded that the Medicines and Healthcare products Regulatory Agency (MHRA)</a>:</p>
<blockquote>
<p>“… like many regulatory organisations, is entirely funded by fees from those it regulates….This situation has led to concerns that it may lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies.” </p>
</blockquote>
<p>The European Medicines Agency recently organized a consultation on pre-submission meetings. In reply the <a href="https://english.prescrire.org/Docu/DOCSEUROPE/20190130_JointResponseEUOmbudsmanScientificAdvice.pdf">International Society of Drug Bulletins and the French drug bulletin, <em>Prescrire</em> wrote</a> that, “EMA’s confidential pre-submission ‘scientific advice’ to companies jeopardises its ability to make independent decisions.” These bodies advised that:</p>
<blockquote>
<p>“… experts involved in providing national pre-submission scientific advice must not be involved in any subsequent evaluation of European marketing authorisation applications for the same medicine.”</p>
</blockquote>
<h2>Weaker standards for approving drugs</h2>
<p>Critics of the intertwined nature of the regulation-industry relationship claim that one of the results is that <a href="https://doi.org/10.1136/bmj.i4437">weaker standards for approving new drugs</a> have become acceptable. </p>
<p>Many drugs are approved on the basis of surrogate endpoints — such as changes in the level of blood sugar or how much cancer tumours shrink — rather than outcomes that really matter to patients, such as whether they’ll have a better quality of life or whether they’ll live longer. </p>
<p>Half the new drugs approved come on the market <a href="https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2011.539">without any comparison to standard therapy,</a> leaving doctors and patients wondering whether the new drug is any better than the old one.</p>
<p>Is Health Canada’s relationship with drug companies the reason why one spokesperson told a reporter for the <em>Toronto Star</em> that the <a href="https://www.thestar.com/news/canada/2014/06/26/dangers_of_offlabel_drug_use_kept_secret.html">reason that it had never prosecuted a drug company</a> for illegally marketing unapproved uses was that it “has not been made aware of any specific similar issue in Canada and has not received complaints concerning these companies promoting off-label uses of their products in Canada?”</p>
<p>Drug companies have a job to do and so does Health Canada. Health Canada should not confuse what those two jobs are.</p>
<p>[ <em>Like what you’ve read? Want more?</em> <a href="https://theconversation.com/ca/newsletters?utm_source=TCCA&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/120965/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2016-2019, Joel Lexchin was a paid consultant on two projects: one looking at developing principles for conservative diagnosis (Gordon and Betty Moore Foundation) and a second deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient Oriented Research Support Unit and the St Michael’s Hospital Foundation). He also received payment for being on a panel at the American Diabetes Association, for a talk at the Toronto Reference Library, for writing a brief in an action for side effects of a drug for Michael F. Smith, Lawyer 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 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>Drug companies have a job to do and so does Health Canada. When the relationship becomes murky, the public are at risk.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/1150962019-04-09T10:46:29Z2019-04-09T10:46:29ZHow a ‘hard’ Brexit would harm US banks, carmakers and drug companies<figure><img src="https://images.theconversation.com/files/268237/original/file-20190408-2924-1hvlp0s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A 'hard Brexit' appears increasingly likely. </span> <span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Britain-Brexit/f621fde2e2b448ca8c541ba38249ce5a/14/0">AP Photo/Kirsty Wigglesworth</a></span></figcaption></figure><p>Nearly three years have passed since <a href="https://theconversation.com/us/topics/brexit-9976">British voters chose to leave the European Union</a>, a decision that created uncertainty and risks that have become a focal point of <a href="https://kelley.iu.edu/faculty-research/faculty-directory/profile.cshtml?id=EMAFIKRE">economic forecasters like me</a>. </p>
<p>Yet the U.K. <a href="https://theconversation.com/3-days-3-key-votes-and-no-end-in-sight-for-brexit-113515">still doesn’t know</a> what sort of <a href="https://theconversation.com/us/topics/brexit-9976">Brexit</a> it wants. Does the U.K. want a <a href="https://theconversation.com/us/topics/soft-brexit-32665">so-called soft Brexit</a> that allows it to keep most of the benefits of EU membership without certain requirements like the open movement of people? Or a <a href="https://theconversation.com/if-the-conservatives-want-to-win-the-next-election-they-should-avoid-a-hard-brexit-leader-heres-why-114939">hard Brexit</a> that essentially isolates the U.K. market from the EU’s? Or something in between?</p>
<p>As a result of this indecision, it has become increasingly possible that the U.K. will not be able to negotiate a favorable withdrawal agreement before the revised deadline of April 12 – <a href="https://www.bloomberg.com/news/articles/2019-04-08/eu-said-closer-to-brexit-delay-deal-as-core-leaders-plan-talks?srnd=premium">though that might be extended</a> by several months, a year or longer. If negotiators can’t agree, that could force a type of <a href="https://theconversation.com/mps-vote-against-no-deal-brexit-but-what-does-that-actually-mean-113492">hard Brexit</a> in which the U.K. crashes out of the EU. While <a href="https://www.itv.com/news/2019-02-10/blair-warns-of-devastating-impact-of-no-deal-brexit-on-ni-peace-process/">politicians</a>, <a href="https://www.economist.com/britain/2019/02/20/what-would-a-no-deal-brexit-mean-for-the-economy-and-financial-markets">economists</a> and <a href="https://www.teenvogue.com/story/young-activists-fighting-brexit-stay-in-european-union">others</a> expect such an outcome to be costly for the U.K. and Europe, it’s much less clear what the impact would be for U.S. companies. </p>
<p>I’ve been <a href="https://ibrc.kelley.iu.edu/analysis/outlook/index.html">forecasting the outlook</a> for U.S. businesses for more than a decade as part of the <a href="http://www.ibrc.indiana.edu/ibr/2018/outlook/international.html">Indiana Business Research Center</a> and also co-author of its annual global economic outlook. </p>
<p>I believe American companies most exposed to Brexit are those with operations in the U.K. and in three specific industries: financial, auto and pharmaceutical. To understand why, it’s important to first learn the U.K.’s special place in the EU for American companies. </p>
<h2>America’s top market in the EU</h2>
<p>The EU is an integrated market that has essentially eliminated all internal trade barriers between its 28 member states. Capital, goods, services and labor move freely across members’ borders. Regulations have been harmonized. And members share a common set of market rules. </p>
<p>This means that every port of entry into the EU – whether in the U.K., Germany or Bulgaria – is virtually the same. Businesses based in non-member countries face the same hurdles no matter where they send their products. </p>
<p>In practice, however, this hasn’t been quite true. American businesses have preferred to use the U.K. as their main gateway to Europe. After the <a href="https://europa.eu/european-union/about-eu/history_en">EU was established</a> in 1993, U.S. companies have opened more subsidiaries and gained strategic partners in the U.K. to do just that. </p>
<p>As a result, the U.K. is the <a href="https://ustr.gov/countries-regions">number one destination for U.S. goods</a> and services within the EU and the <a href="https://www.bea.gov/news/2018/direct-investment-country-and-industry-2017">second-biggest recipient</a> of American investment. The U.K. is also the <a href="https://www.bea.gov/data/intl-trade-investment/foreign-direct-investment-by-country-and-industry">biggest investor</a> in the U.S. </p>
<p>The reasons why may be rooted in the fact that the U.S. and the U.K. share a common history and a common language and have cultural ties. For U.S. businesses, removing the <a href="https://www.sciencedirect.com/science/article/pii/S0165176510003617">language barrier</a> makes the U.K. a relatively low-cost entry point into the EU market. </p>
<p>Few sectors have gained more from this close relationship than financial institutions, carmakers and drug manufacturers. That also means they have the most to lose if Brexit gets messy. </p>
<h2>1. Banks and the end of ‘passporting’</h2>
<p><a href="https://blogs.lse.ac.uk/brexit/2018/01/09/passporting-remains-the-best-option-for-uk-financial-services-industry-post-brexit-or-new-york-may-have-the-last-laugh/">One of the reasons</a> London became the EU’s largest financial center – and the primary conduit to Europe for U.S. banks – is because of something known as “<a href="https://www.investopedia.com/terms/p/passporting.asp/">passporting</a>.” </p>
<p>Passporting allows a company granted regulatory permission to undertake certain activities in one member state to do the same business in every other EU country. In practice, this has meant a U.S. financial company could simply open up an office in London to have access to the entire market. U.K.-based employees were then free to work in any other country in the EU.</p>
<p>But a hard Brexit would change that. U.S. banks with U.K. subsidiaries <a href="https://www.cbsnews.com/news/brexit-how-a-messy-eu-divorce-could-hit-u-s-businesses/">may need to obtain a new license</a> from regulators in every EU country they operate in, which would disrupt operations. </p>
<p>While this is a problem American companies in many industries are facing – including car and drug manufacturers – it would affect financial firms most because they operate in a sector that’s entirely service-based, which means labor is their biggest risk. If employees can’t travel and do their jobs freely throughout the EU market, the costs could be significant. </p>
<h2>2. Auto industry and thick borders</h2>
<p>U.S. carmakers have their own problems. </p>
<p>Auto companies such as Ford Motor Co. have invested billions of dollars in U.K. manufacturing plants, which give them tariff-free access to other European assembly plants. Ford has located its engine production in the U.K., which needs to be freely connected to plants across Europe that assemble vehicles.</p>
<p>The growing possibility of a hard Brexit <a href="https://www.independent.co.uk/news/business/news/ford-no-deal-brexit-uk-car-manufacturing-investment-steven-armstrong-a8851356.html">is stoking worries</a> among American carmakers that production could be severely disrupted as parts distributed among EU members suffer greater U.K. border delays and currency risks. </p>
<p>In regards to border delays, Ford operates its factories on a <a href="https://www.inboundlogistics.com/cms/article/the-evolution-of-inbound-logistics-the-ford-and-toyota-legacy-origin-of-the-species/">“just-in-time” basis</a>, which means that most parts only arrive as needed in the production process to keep inventory costs at a minimum. For this process to work, however, the whole delivery system has to be frictionless, which may not be the case after Brexit. </p>
<p>In regards to currency risk, it is a double-sided risk. If the pound depreciates, the parts needed to make an engine at a U.K. plant will become more costly to import from a EU country. And if the pound appreciates, the engine assembled in the U.K. will be more expensive to export back to the EU.</p>
<p>Ford estimates that a hard Brexit could cost the company <a href="https://www.reuters.com/article/uk-britain-eu-ford/no-deal-brexit-would-cost-ford-up-to-1-billion-idUSKCN1PI1VD">US$500 million to $1 billion</a>. To minimize the cost, Ford has begun preparing for these potential disruptions by <a href="https://www.reuters.com/article/us-britain-eu-ford/brexit-leaves-ford-at-crossroads-on-long-term-british-plans-idUSKCN1RE10I">stockpiling parts and engaging in currency hedging</a>. </p>
<p>A third risk is what happens if the EU and U.K. follow different safety, emission and other performance standards. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/268231/original/file-20190408-2935-1h5z5qa.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/268231/original/file-20190408-2935-1h5z5qa.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/268231/original/file-20190408-2935-1h5z5qa.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/268231/original/file-20190408-2935-1h5z5qa.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/268231/original/file-20190408-2935-1h5z5qa.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/268231/original/file-20190408-2935-1h5z5qa.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/268231/original/file-20190408-2935-1h5z5qa.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 EU’s equivalent of the FDA is relocating to Amsterdam from London.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Netherlands-EU-Medicines-Agency/8327d86f58054594926a776ff94eefb8/5/0">AP Photo/Peter Dejong</a></span>
</figcaption>
</figure>
<h2>3. Drugmakers face new hurdles</h2>
<p>While the problem of dealing with potentially two different sets of standards will certainly affect companies in other industries such as carmakers, it’s a significant worry for pharmaceutical manufacturers, who face strict laws for selling their drugs in the EU. </p>
<p>The <a href="https://www.ema.europa.eu/en/about-us/united-kingdoms-withdrawal-european-union-brexit">European Medicines Evaluation Agency</a>, which is the EU’s equivalent to the U.S. Food and Drug Administration, allows pharmaceutical companies to submit a single application to obtain authorization to sell a drug throughout the common market. Since its inception, the agency has been located in London, which led many U.S. drugmakers to base their EU operations in the U.K. The agency is now relocating to Amsterdam, <a href="https://www.newstatesman.com/politics/health/2017/04/what-happens-when-european-medicines-agency-leaves-uk">putting foreign drugmakers in a bind</a>.</p>
<p>EU law requires that drugs be tested on EU soil. Since the U.K. will no longer be in the EU after Brexit, U.S. drugmakers may have to relocate their testing facilities. If they don’t, they will face higher costs and obstacles getting their products to EU customers. Pfizer, for example, is estimating that it will incur <a href="http://fortune.com/2018/09/04/pfizer-uk-brexit-cost-100-million/">Brexit costs of $100 million</a>, including changes to clinical trials and stockpiling of drugs for emergency supplies.</p>
<p>Since no EU member state has previously decided to leave the bloc, there is no precedent for this situation, making the ability to forecast the implications near impossible. The good news is that Brexit’s disruption will only be felt temporarily in the transition period. Eventually U.S. companies will get to a new normal of doing business with the EU.</p>
<p>The bad news? The longer that Brexit gets dragged along, the more these transition costs will accumulate.</p><img src="https://counter.theconversation.com/content/115096/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Elham Mafi-Kreft 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>American companies still face enormous uncertainty about how they’ll be doing business in the UK and EU in the coming years, particularly as the April 12 Brexit deadline draws closer.Elham Mafi-Kreft, Clinical Associate Professor of Business Economics, Indiana UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1108882019-02-04T19:21:00Z2019-02-04T19:21:00ZInfluential doctors aren’t disclosing their drug company ties<figure><img src="https://images.theconversation.com/files/256551/original/file-20190131-112314-ra41n4.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The lack of transparency seems to be worse in certain disease areas, including diabetes and heart disease.</span> <span class="attribution"><a class="source" href="https://unsplash.com/photos/k1wAR6d254Y">rawpixel</a></span></figcaption></figure><p>In September, the <a href="https://www.nytimes.com/2018/09/08/health/jose-baselga-cancer-memorial-sloan-kettering.html">New York Times</a> revealed that one of the world’s top cancer specialists had quietly received millions of dollars from drug and other companies. And what’s more, he’d failed to disclose the payments in many of his high-profile medical journal articles.</p>
<p>A few months before that, <a href="https://www.tandfonline.com/doi/abs/10.1080/23294515.2018.1436095?journalCode=uabr21">a study</a> found that many experts who write medical textbooks received company payments, but again, their readers didn’t know about it.</p>
<p>Today our <a href="https://bmjopen.bmj.com/content/9/2/e025864">Australian stud</a>y of the doctors who write influential clinical guidelines has uncovered a similar problem. At least one in five of them have had a financial relationship with a drug company that was not disclosed in the guidelines.</p>
<p>This is a huge concern because guidelines can have big impacts on the sort of care you receive from a doctor, and on which drugs they prescribe. And <a href="https://theconversation.com/drug-companies-are-buying-doctors-for-as-little-as-a-16-meal-61364">receiving benefits</a> like free lunches or consulting fees from companies may cause bias.</p>
<p>Only last month a <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2720914?guestAccessKey=93e16635-e1d4-4a4f-ba66-d2b80510cfe2">massive research investigation</a> in the United States found a link between marketing payments to doctors, and local deaths from opioids.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/drug-companies-are-buying-doctors-for-as-little-as-a-16-meal-61364">Drug companies are buying doctors – for as little as a $16 meal</a>
</strong>
</em>
</p>
<hr>
<h2>Narrowing the search</h2>
<p>Our research team from Bond and Sydney universities also included officials from the National Health and Medical Research Council, which is currently trying to improve the quality of Australian guidelines for doctors.</p>
<p>The team identified a random sample of guidelines, drawn from a comprehensive set, which covered ten major disease areas, including heart disease and mental health.</p>
<p>We then looked at what was disclosed in each guideline about any relationships between guideline authors and drug companies. If an author did not have any information, we searched through all the articles that author had published in the scientific literature in the previous five years.</p>
<p>We were specifically looking to see if a guideline author had any links with a drug company which sold products in the disease area that the author’s guideline covered. </p>
<h2>What we found</h2>
<p>The study, published today in <a href="https://bmjopen.bmj.com/">BMJ Open</a>, found at least one in five of all guideline writers had a potentially relevant tie to a drug company, which was not disclosed in the guideline. And two-thirds of all the guidelines had at least one author with a tie that wasn’t disclosed.</p>
<p>We also found this lack of transparency may be worse in certain disease areas, including diabetes and heart disease. </p>
<p>This raises very serious questions about hidden bias and the trustworthiness of these guidelines – which have such an impact on how our doctors make decisions.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/256967/original/file-20190204-193195-pajjta.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/256967/original/file-20190204-193195-pajjta.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=338&fit=crop&dpr=1 600w, https://images.theconversation.com/files/256967/original/file-20190204-193195-pajjta.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=338&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/256967/original/file-20190204-193195-pajjta.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=338&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/256967/original/file-20190204-193195-pajjta.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=424&fit=crop&dpr=1 754w, https://images.theconversation.com/files/256967/original/file-20190204-193195-pajjta.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=424&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/256967/original/file-20190204-193195-pajjta.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">Clinical guidelines can have big impacts on the sort of care you receive from a doctor, and on which drugs they prescribe.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/phonendoscope-doctor-arm-453801829?src=tx3TtqaoyXPL1wVmOLzrqA-1-101">New_World/Shutterstock</a></span>
</figcaption>
</figure>
<p>As part of the analysis we compared guidelines which had been funded and developed by governments, as opposed to say specialist groups or medical foundations. </p>
<p>We found guidelines funded and developed by state, federal or territory governments had much lower rates of authors not disclosing their drug company links.</p>
<p>Other similar studies have looked at guidelines like this, but to our knowledge today’s is the biggest and broadest, and the first ever in Australia.</p>
<h2>More transparency and greater independence</h2>
<p>Despite what you might hear, drug company <a href="https://theconversation.com/whos-paying-for-lunch-heres-exactly-how-drug-companies-wine-and-dine-our-doctors-78395">wining and dining</a> of doctors and other health professionals like pharmacists and nurses, is not a thing a past. There are perhaps 25,000 events or more every year in Australia where drug companies provide free hospitality. </p>
<p>At the same time many senior specialists, like the ones who write guidelines, continue to receive all manner of company benefits as consultants, speakers or sponsored researchers.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/whos-paying-for-lunch-heres-exactly-how-drug-companies-wine-and-dine-our-doctors-78395">Who's paying for lunch? Here's exactly how drug companies wine and dine our doctors</a>
</strong>
</em>
</p>
<hr>
<p>But there is widespread concern about these links, and a growing push for much greater transparency in medicine. The United States has the <a href="https://theconversation.com/pharma-payments-to-doctors-stay-behind-closed-doors-for-now-15279">Sunshine Act</a>, which forces disclosure of all company payments to all doctors. </p>
<p>Australia’s rules have changed since the time our study covers, and some payments to individual doctors are now routinely disclosed. But our rules have huge loopholes and are much weaker than the Sunshine Act, a reform that is well overdue in Australia.</p>
<p>While disclosure and transparency are needed, they don’t solve the problem of bias that flows from close financial relationships between doctors and drug companies.</p>
<p>For such influential things as guidelines – which can impact the care of millions of people – it may be best to have writers totally free of ties to industry. And this is exactly what a <a href="https://nhmrc.gov.au/guidelinesforguidelines/plan/identifying-and-managing-conflicts-interest">new policy</a> from Australia’s National Health and Medical Research Council is recommending.</p>
<p>The new policy, launched just a few months ago, is very clear in its preference: </p>
<blockquote>
<p>It is strongly encouraged that your guideline development group will be composed of members with no financial or other links to relevant industry groups.</p>
</blockquote>
<p>Let’s wait and see who is listening.</p><img src="https://counter.theconversation.com/content/110888/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ray Moynihan receives research funding from NHMRC. </span></em></p><p class="fine-print"><em><span>Lisa Bero receives funding from NHMRC and is a member of the NHMRC Advisory Group on the Synthesis and Translation of Research Evidence.. </span></em></p>Clinical guidelines have a big impact on the care you receive and the drugs you’re prescribed. But one in five doctors who write these guidelines have undisclosed ties to drug companies.Ray Moynihan, Senior Research Fellow, Bond UniversityLisa Bero, Chair professor, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/981282018-06-13T23:12:20Z2018-06-13T23:12:20ZCan you rely on the drugs that your doctor prescribes?<figure><img src="https://images.theconversation.com/files/222864/original/file-20180612-112599-1wl397r.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The reliability of a new guideline for the management of chronic hepatitis C is questionable, given the financial conflicts of interest documented by its authors. </span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>The <em>Canadian Medical Association Journal</em> (CMAJ) has just published a <a href="http://www.cmaj.ca/content/190/22/E677">new guideline for the management of hepatitis C</a> — a disease that is underdiagnosed and undertreated in Canada. </p>
<p>This guideline is aimed at doctors and details recent advances in treating adults with chronic hepatitis C virus infection. It was produced by a committee from the Canadian Association for the Study of the Liver (CASL).</p>
<p>As the complexity of medical care grows exponentially, clinical guidelines such as this become increasingly important in helping doctors weave their way through the diagnosis and treatment of disease. <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2219863/">As the number of guidelines increases, so too does their influence</a>. </p>
<p>Well-constructed medical guidelines can be a boon to patient care, but <a href="http://dx.doi.org/10.1136/ebmed-2017-110845">poor guidelines have the potential for harm</a>. There are two interrelated threats. The first is when committee members have a financial conflict of interest (FCOI) with companies producing products recommended in the guidelines. The second occurs when guidelines rely on poor quality evidence.</p>
<p>In the lead up to the <a href="http://www.globalhepatitissummit2018.com">Global Hepatitis Summit 2018</a>, to be held in Toronto on June 14-17, we believe there are reasons to be concerned about this new hepatitis C guideline on both counts.</p>
<p>First, all eight authors of the CMAJ article, including the chair, declared FCOI with companies that produced the drugs recommended in the guideline. Second, the committee did not include an expert on evidence evaluation or someone representing the public or patients. </p>
<h2>Do guidelines recommend the best drugs?</h2>
<p>One of the authors of this article (Joel Lexchin) was part of a study that looked at <a href="https://doi.org/10.1186/s12913-016-1646-5">FCOI in Canadian medical guidelines</a>. We examined 28 guidelines that recommended drug treatment for a wide variety of diseases. </p>
<p>In more than 25 per cent of these documents, over half of the authors disclosed FCOI with manufacturers of drugs that they recommended. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/222869/original/file-20180612-112605-1qqi3m5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/222869/original/file-20180612-112605-1qqi3m5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/222869/original/file-20180612-112605-1qqi3m5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/222869/original/file-20180612-112605-1qqi3m5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/222869/original/file-20180612-112605-1qqi3m5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/222869/original/file-20180612-112605-1qqi3m5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/222869/original/file-20180612-112605-1qqi3m5.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">3D illustration of the hepatitis C virus (HCV)</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>The <a href="https://doi.org/10.1111/jep.12016">guideline for the treatment of patients with major depressive disorder</a> from the American Psychiatric Association was studied by Lisa Cosgrove, the second author of this article. Financial ties to industry were disclosed by all members of this guideline development committee. </p>
<p>The presence of this FCOI may have been the reason why fewer than half of the studies cited in support of the recommendations met criteria for high quality and why 17 per cent did not measure clinically relevant results.</p>
<p>To guard against the corruption of guidelines, safeguards have been put in place. The U.S. Institute of Medicine (IOM), now the National Academy of Medicine, has <a href="https://www.ncbi.nlm.nih.gov/books/NBK209539/">recommendations about the membership on guideline committees</a>. According to them, the chair and the majority of members should be free of FCOI and the committee should include an expert in the evaluation of evidence and a patient or public representative. </p>
<p>When the highly respected <a href="http://www.cochrane.org/">Cochrane organization</a> produces medical guidelines, it explains in detail why studies are included or excluded. It also evaluates the multiple sources of bias that potentially exist in all studies.</p>
<p>The point about bias is extremely important as there is <a href="http://www.cochrane.org/MR000033/METHOD_industry-sponsorship-and-research-outcome">good evidence that studies financed by drug and device manufacturers are much more likely to report positive results</a> and conclusions, compared with studies with any other source of funding.</p>
<p>Finally, guidelines produced by industry-tied authors tend to <a href="http://ebm.bmj.com/content/ebmed/23/1/33.full.pdf">recommend expensive drugs</a> despite a lack of evidence for their safety and efficacy.</p>
<h2>Silent on many questions</h2>
<p>So, how valuable is a guideline for the management of hepatitis C, in which eight authors declared FCOI with recommended drug producers? How reliable are the recommendations from a committee that did not document how evidence was evaluated or include a public or patient representative?</p>
<p>The committee did attempt to get around some of these deficiencies. First the guideline explicitly states: “No funding, direct or in kind, was provided to the guideline panel for this work.” Second, “in order to manage competing interests, the final guideline was vetted by the Canadian Association for the Study of the Liver membership, and specifically by the association’s executive.” Third, the “guideline was circulated by email to community organizations that represented patients.”</p>
<p>Who were the community organizations and did they have ties with the companies making the drugs the guideline recommends? The guideline is silent on these questions. </p>
<p>Who is on the executive of CASL? Do they as individuals have links with industry? Does the association itself have links? </p>
<p>Getting even partial answers to these questions requires some digging. A simple Google search on “Canadian Association for the Study of the Liver” doesn’t produce any direct links. The closest is a link to the <a href="https://canlivj.utpjournals.press/">Canadian Liver Journal</a>. Visit this page, click around a few more times and eventually you get to the <a href="http://www.hepatology.ca">CASL website</a>.</p>
<p>There are 33 people on the executive board including three of the guideline committee members; so, executive committee members were reviewing what they themselves had written. </p>
<p>Did the other 30 members have any FCOI to declare? There’s no information about these people on the website. The website does say that CASL only <a href="http://www.hepatology.ca/wp-content/uploads/2016/12/EndorsementPolicy_May192015_v4.pdf">endorses requests produced by a not-for-profit organization</a> and that it “does not endorse or support any commercial diagnostic or therapeutic products.” </p>
<p>But <a href="http://www.hepatology.ca/?page_id=1817">Gilead Science, Merck and AbbVie were all 2018 sponsors of Association Hepatology Fellowships</a>. Gilead and AbbVie both produce hepatitis C drugs and <a href="https://www.reuters.com/article/us-merck-co-hepatitis-c/merck-to-stop-development-of-hepatitis-c-treatments-idUSKCN1C41QD">Merck was working in this field</a> until October 2017. </p>
<p>Does CASL get money from drug companies? Silence once more.</p>
<p>There is nothing in the guideline about why studies were included or excluded, nothing about how the information was abstracted from the studies and nothing about whether they were checked for biases.</p>
<h2>Guidelines must be bias-free</h2>
<p>The appearance of this guideline in the CMAJ raises serious questions about the journal’s standards for publishing guidelines. The article was peer reviewed and FCOI was declared, but should the journal do more? </p>
<p>Should it require the composition of guideline committees to conform to the standards set by the National Academy of Medicine? </p>
<p>Should there have to be information about FCOI of the organization sponsoring the guidelines? </p>
<p>Should there have to be explicit information about how studies were selected and evaluated?</p>
<p>Guidelines have to be seen as free of bias in order for doctors to have confidence in them. The new hepatitis C guideline published by the <em>Canadian Medical Association Journal</em> fails the bias test.</p><img src="https://counter.theconversation.com/content/98128/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2015-2018, Joel Lexchin was a paid consultant on three projects: one looking at indication-based prescribing (United States Agency for Healthcare Research and Quality), a second to develop principles for conservative diagnosis (Gordon and Betty Moore Foundation) and a third deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient Oriented Research Support Unit and the St Michael’s Hospital Foundation). He also received payment for being on a panel that discussed a pharmacare plan for Canada (Canadian Institute, a for-profit organization). 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 member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare.</span></em></p><p class="fine-print"><em><span>Lisa A Cosgrove 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>In the run up to the Global Hepatitis Summit 2018, new guidelines for the management of hepatitis C should come under scrutiny – for financial conflict of interest and quality of 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 TorontoLisa A Cosgrove, Professor Counseling Psychology Doctoral Program, UMass BostonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/933432018-03-14T22:51:34Z2018-03-14T22:51:34ZPharmacare and the chaotic world of Canadian drug prices<p>The cost of a life-saving drug to treat cystinosis — a rare disease affecting probably 100 people across Canada — is soon to rise from <a href="http://www.cbc.ca/news/health/second-opinion-procysbi-cystagon-march10-1.4570152">$10,000 per year to more than $300,000 annually</a>.</p>
<p>The new form of the drug, Procysbi, contains the same active ingredient as the old form of the drug, Cystagon. It differs only in that it contains a new coating, enabling a slower release of chemicals into the body. </p>
<p><a href="http://www.gazette.gc.ca/rp-pr/p1/2017/2017-12-02/html/reg2-eng.html">Reforms to the Patented Medicine Prices Review Board (PMPRB)</a>, a federal agency that sets a maximum introductory price for new patented drugs, could help rein in this type of increase. </p>
<p>But a coalition of patient groups, some partially funded by drug companies, want Canada’s health minister and Health Canada to <a href="https://www.newswire.ca/news-releases/canadian-patient-groups-call-on-federal-health-minister-to-halt-the-process-examining-proposed-amendments-to-the-patented-medicine-regulations-pending-constructive-consultations-674144623.html">stop this reform process</a>. They argue that lowering drug prices in the manner proposed could limit access to new drugs. </p>
<p>The drug companies are backing them up. </p>
<h2>Canadians pay the price</h2>
<p><a href="http://healthydebate.ca/2018/03/topic/canada-drug-prices">According to Pamela Fralick</a>, the CEO of Innovative Medicines Canada (IMC), the lobby group representing the multinational subsidiaries operating in Canada: “The proposed changes would negatively affect patients by slowing and limiting access to new, life-saving medicines and vaccines, and will have consequences for investment and employment in Canada’s life science sector.”</p>
<p>IMC and its predecessors have been making the same type of veiled threat since the early 1970s, when Manitoba introduced its public drug formulary, a list of drugs the province would cover. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/210172/original/file-20180313-30958-lqf885.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/210172/original/file-20180313-30958-lqf885.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/210172/original/file-20180313-30958-lqf885.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/210172/original/file-20180313-30958-lqf885.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/210172/original/file-20180313-30958-lqf885.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/210172/original/file-20180313-30958-lqf885.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/210172/original/file-20180313-30958-lqf885.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">With a national pharmacare plan, all Canadians would benefit from lower drug prices.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>While there are drugs that are not sold in Canada, the reason is the relatively small Canadian market, not the price. </p>
<p>In fact, when it comes to paying for prescription drugs, <a href="http://dx.doi.org/10.1787/health_glance-2017-en">only the United States and Switzerland outspend Canada</a> on a per capita basis out of 31 industrialized countries in the Organization for Economic Cooperation and Development. </p>
<p>There are now <a href="http://www.pmprb-cepmb.gc.ca/view.asp?ccid=1334">19 drugs on the Canadian market that cost $50,000 or more per year</a>, compared to just six a decade ago. </p>
<p>And, contrary to what IMC claims and what the patient groups seem to believe, <a href="http://www.pmprb-cepmb.gc.ca/view.asp?ccid=1334">only one in 10 new drugs are actually major therapeutic improvements</a>.</p>
<h2>Increase of 3,000 per cent</h2>
<p>The dramatic rise in the cost of treating cystinosis — a genetic disease that causes kidney damage — reflects the dysfunctional nature of the way Canada controls drug prices. </p>
<p>Up until now, the treatment has been a product called Cystagon that must be vetted by Health Canada on a patient-by-patient basis since it’s not approved for sale in Canada. Now the newer version of the drug, Procysbi, made by Horizon Pharma — and taken twice instead of four times daily — is being marketed in Canada. </p>
<p>With the advent of Procysbi, the cheaper Cystagon will no longer be available to Canadian patients. Under the current rules enforced by the PMPRB, Procysbi is treated as a “breakthrough drug,” which is why the 3,000 per cent price increase was permitted.</p>
<p>Again — the only difference between Cystagon and Procysbi is the latter has a special coating enabling its release into the body more slowly. </p>
<p>All of the basic research and development of Procysbi was <a href="http://www.cbc.ca/news/health/second-opinion-procysbi-cystagon-march10-1.4570152">financed by patient groups, not drug companies</a>. Horizon Pharma has not publicly offered any reason for the price it plans to charge. The company is going to offer the drug for free for a limited time, but what happens when that option ends? </p>
<p>This isn’t the first time there’s been sticker shock about drug prices in Canada. In September 2017, the PMPRB ordered <a href="http://www.cbc.ca/news/health/solaris-pmprb-1.4310249">Alexion Pharmaceuticals to lower the $700,000 annual cost of Soliris</a>, used in the treatment of rare blood disorders. </p>
<p>The pan-Canadian Pharmaceutical Alliance, a coalition of provincial and federal drug plans, bargains with companies for lower prices and is in negotiations with Horizon Pharma. But even if it can secure a discount, that will only apply to what provincial drug plans pay. </p>
<p>Private drug plans and people paying out of pocket, assuming anyone could actually afford Procysbi, will not get the discount.</p>
<h2>National pharmacare a solution</h2>
<p>A <a href="https://theconversation.com/canadian-pharmacare-is-closer-to-becoming-a-reality-92646">national pharmacare plan</a> could help to bring some order to the chaotic world of Canadian drug prices. Everyone in the country would be covered under a public plan and benefit from the lower drug prices that would be achieved. </p>
<p>Pharmacare doesn’t necessarily mean that drugs will sell for pennies. But based on the experience in other countries, we will be much better off. </p>
<p>If companies don’t like the price being offered, then they could still try to sell their drugs to those who could afford them, but the market would typically be very small, encouraging the companies to lower prices. </p>
<p>However, Finance Minister Bill Morneau doesn’t seem interested in a universal pharmacare plan, <a href="http://www.richmond-news.com/cmlink/gmg-glacier-media-group/2.2062/critics-call-for-morneau-s-ouster-from-pharmacare-file-over-remarks-about-study-1.23189183">preferring to try to fill gaps and add to the patchwork</a> in the existing system, although now he seems to be backing off from his initial comments.</p>
<p>Perhaps people with cystinosis should ask Morneau to cover their costs.</p><img src="https://counter.theconversation.com/content/93343/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2015-2017, Joel Lexchin was a paid consultant on two projects: one looking at indication-based prescribing (United States Agency for Healthcare Research and Quality) and a second deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient Oriented Research Support Unit and the St Michael's Hospital Foundation). He also received payment for being on a panel that discussed a pharmacare plan for Canada (Canadian Institute, a for-profit organization). He is a principle investigator on projects funded by the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is member of the Foundation Board of Health Action International.</span></em></p>The cost of a life-saving drug in Canada is rising by 3,000 per cent. A national pharmacare plan could bring order to this chaotic world of Canadian drug prices.Joel Lexchin, Board member of Canadian Doctors for Medicare, Professor Emeritus of Health Policy and Management, York University and Associate Professor of Family and Community Medicine, University of TorontoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/898512018-01-11T02:59:44Z2018-01-11T02:59:44ZWhy a drug treatment for dementia has eluded us<figure><img src="https://images.theconversation.com/files/201263/original/file-20180109-83553-1tp4671.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Have our hopes of a drug treatment for dementia been dashed by drug company Pfizer giving up on research efforts?</span> <span class="attribution"><span class="source">from www.shutterstock.com</span></span></figcaption></figure><p>Finding a cure for neurodegenerative diseases such as Alzheimer’s is challenging. They’re difficult to diagnose, and drugs struggle to get into the brain as the brain’s blood supply is largely separate to the rest of the body. Not surprisingly, several companies have left this territory in recent years. This week, <a href="http://www.theaustralian.com.au/news/world/the-times/pfizer-gives-up-on-dementia-research/news-story/953541b4f4abfababdda34fd141829f8">pharmaceutical giant Pfizer</a> announced it will stop research into developing drugs to treat Alzheimer’s disease, after costly failed attempts over the past decade. </p>
<p>In recent years some clinical trials involving potential dementia drugs have had disappointing setbacks. In 2012, Pfizer and Johnson & Johnson halted development of the antibody drug bapineuzumab, after it <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1304839#t=abstract">failed in late-stage trials</a> to treat patients with mild to moderate Alzheimer’s. </p>
<p>Despite this week’s announcement, Pfizer’s support of the UK’s <a href="https://www.pfizer.com/news/featured_stories/featured_stories_detail/pfizer_commits_support_to_the_dementia_discovery_fund">Dementia Discovery Fund</a>, an initiative involving the government, major pharmaceutical companies, and Alzheimer’s Research UK, may be where their money can make the most impact in this space. The fund aims to boost dementia research investment by financing early-stage drug development projects. And other pharma companies, such as Eli Lilly, Biogen and Novartis have continued to pursue dementia drug development with modest but promising success to date.</p>
<p>So what makes dementia such a difficult condition to treat with drugs, and is progress being made towards a treatment?</p>
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<strong>
Read more:
<a href="https://theconversation.com/alzheimers-breakthrough-have-we-nearly-cured-dementia-not-just-yet-62435">Alzheimer's breakthrough? Have we nearly cured dementia? Not just yet...</a>
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<h2>Why dementia is so hard to treat</h2>
<p>Despite the vast number of people affected globally, with an estimated <a href="https://www.alz.co.uk/research/statistics">46.8 million people</a> currently living with dementia, there is currently no cure. While current treatments manage symptoms (the latest drug to gain FDA approval was <a href="https://www.alzforum.org/therapeutics/memantine">memantine</a>, in 2003) they offer no prospect of recovery. </p>
<p>Part of the difficulty in finding treatments for dementia stems from the fact it’s not a single disease, but a complex health problem with more than 50 underlying causes. Dementia can be better thought of as an umbrella term describing a range of conditions that cause parts of the brain to deteriorate progressively.</p>
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Read more:
<a href="https://theconversation.com/what-causes-alzheimers-disease-what-we-know-dont-know-and-suspect-75847">What causes Alzheimer’s disease? What we know, don’t know and suspect</a>
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<p>Most drug treatments currently in development have targeted the pathology of Alzheimer’s disease, the most common form of dementia, which accounts for <a href="https://www.alz.org/alzheimers_disease_what_is_alzheimers.asp">about 60 to 70%</a> of all cases. </p>
<p>Finding a successful treatment for Alzheimer’s faces two major hurdles: the first being we still don’t know enough about the disease’s underlying biology. For example, we don’t know what exactly regulates the toxic build-up of amyloid-β plaques and tau tangles in the brain that are found in Alzheimer’s patients, <a href="https://www.nature.com/articles/nrneurol.2017.162">which specific types of these are toxic</a>, or why the disease progresses at different rates in different people. </p>
<p>It doesn’t help that symptoms of Alzheimer’s develop gradually and slowly and a diagnosis might only be made years after the brain has started to undergo neurodegenerative changes. To boot, it’s not uncommon for Alzheimer’s to be present as well as other forms of dementia.</p>
<p>The second major hurdle to finding a treatment is that drugs need to first cross the <a href="https://theconversation.com/explainer-what-is-the-blood-brain-barrier-and-how-can-we-overcome-it-75454">blood-brain barrier</a>. The blood–brain barrier provides a defence against disease-causing pathogens and toxins that may be present in our blood, and by design exists to keep out foreign substances from the brain. The downside is that it also keeps the vast majority of potential drug treatments from reaching the brain.</p>
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Read more:
<a href="https://theconversation.com/explainer-what-is-the-blood-brain-barrier-and-how-can-we-overcome-it-75454">Explainer: what is the blood-brain barrier and how can we overcome it?</a>
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<a href="https://images.theconversation.com/files/201581/original/file-20180111-46703-13gwb7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/201581/original/file-20180111-46703-13gwb7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/201581/original/file-20180111-46703-13gwb7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/201581/original/file-20180111-46703-13gwb7.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/201581/original/file-20180111-46703-13gwb7.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/201581/original/file-20180111-46703-13gwb7.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/201581/original/file-20180111-46703-13gwb7.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/201581/original/file-20180111-46703-13gwb7.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">The brain has a blood barrier that protects it from pathogens that invade the rest of our body, which also means drugs can’t get in there.</span>
<span class="attribution"><span class="source">from www.shutterstock.com</span></span>
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<h2>Promising steps in the right direction</h2>
<p>Currently available medications such as those which block the actions of an enzyme that destroys an important chemical messenger in the brain for memory (acetylcholinesterase inhibitors) or blocks the toxic effects of another messenger, glutamate (memantine) temporarily manage symptoms. But new treatments are focused on slowing or reversing the disease process itself, by targeting the underlying biology. </p>
<p>One approach, called immunotherapy, involves creating antibodies that bind to abnormal developments in the brain (such as amyloid-β or tau), and mark them for destruction by a range of mechanisms. Immunotherapy is experiencing a surge of interest and a number of clinical trials – targeting both amyloid-β and tau – are currently underway.</p>
<p>Aducanumab, an antibody targeting amyloid-β, has <a href="https://www.nature.com/articles/nature19323">shown promise</a> in <a href="https://theconversation.com/randomised-control-trials-what-makes-them-the-gold-standard-in-medical-research-78913">clinical trials</a> and phase 3 trials are currently ongoing, as are <a href="https://www.nature.com/articles/nrd.2017.155">several tau-based strategies</a>. If any are successful, we would have a vaccine for Alzheimer’s.</p>
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<p>
<em>
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Read more:
<a href="https://theconversation.com/how-australians-die-cause-3-dementia-alzheimers-57341">How Australians Die: cause #3 – dementia (Alzheimer's)</a>
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<p>It’s estimated only 0.1% of antibodies circulating in the bloodstream enter the brain – this also includes the therapeutic antibodies currently used in clinical trials. An approach my team is taking is to use ultrasound to temporarily open the blood-brain barrier, which increases the uptake of Alzheimer’s drugs or antibody fragments. </p>
<p>We’ve had success in mice, finding ultrasound can <a href="https://qbi.uq.edu.au/article/2017/04/ultrasound-boosts-success-alzheimer%E2%80%99s-drug">clear toxic tau protein clumps</a>, and that combining ultrasound with an antibody fragment treatment is more effective than either treatment alone in removing tau and reducing Alzheimer’s symptoms. The next challenge will be translating this success into human clinical trials. </p>
<p>The task of dementia drug development is no easy feat, and requires collaboration across government, industry and academia. In Australia, the National Dementia Network serves this purpose well. It’s only through perseverance and continued investment in research that we’ll one day have a treatment for dementia.</p>
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<p><em>With thanks to Queensland Brain Institute Science Writer Donna Lu.</em></p><img src="https://counter.theconversation.com/content/89851/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jürgen Götz receives funding from the National Health and Medical Research Council, the Queensland Department of Science, Information Technology and Innovation, and the Clem Jones Foundation. </span></em></p>Because we’re still not sure exactly what causes dementia, finding a treatment is difficult.Jürgen Götz, Director, Clem Jones Centre for Ageing Dementia Research, The University of QueenslandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/741442017-03-17T00:06:45Z2017-03-17T00:06:45ZSky-high drug prices for rare diseases show why Orphan Drug Act needs reform<figure><img src="https://images.theconversation.com/files/160595/original/image-20170313-9620-7duhkb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The FDA headquarters in Silver Spring, Maryland.</span> <span class="attribution"><span class="source">AP/Andrew Harnick</span></span></figcaption></figure><p>When <a href="https://www.wsj.com/articles/marathon-pharmaceuticals-to-charge-89-000-for-muscular-dystrophy-drug-1486738267">Marathon Pharmaceuticals</a> announced in February it would market a drug for treating Duchenne muscular dystrophy for US$89,000 a year, the negative reaction was so intense that the company immediately suspended the rollout. (On Thursday, March 16, Marathon announced it was selling the drug to PTC Therapuetics for US$140 million in cash and stock, plus a one-time payment of $50 million if sales reach a certain milestone).
Even the industry’s <a href="http://www.bizjournals.com/chicago/news/2017/02/17/89-000-drug-could-cost-marathon-pharma-its-place.html">trade group</a> cried foul.</p>
<p>A good part of the outrage stemmed from the fact that FDA approval of the drug simultaneously closed the door on <a href="http://www.bizjournals.com/chicago/news/2017/02/17/89-000-drug-could-cost-marathon-pharma-its-place.html">much cheaper imports</a>. Deflazacort, a steroid which Marathon wanted to market in the U.S. under the brand name Emflaza, has been sold abroad for decades. The cost to U.S. families who imported it was only <a href="http://www.bizjournals.com/chicago/news/2017/02/17/89-000-drug-could-cost-marathon-pharma-its-place.html">$1,000 to $1,600 a year</a>.</p>
<p>The outrage was intensified by the nature of the patients. Duchenne muscular dystrophy predominantly affects boys, depriving them of the ability to walk by ages seven to 15 and killing them in their late teens and 20’s. <a href="https://www.cdc.gov/ncbddd/musculardystrophy/data.html">It strikes about one in 7,500 males between the ages of five and 24.</a></p>
<p>The Marathon case is the latest example of what has gone wrong with the <a href="https://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/OrphanDrugAct/">Orphan Drug Act (ODA)</a>, which was passed 34 years ago to promote development of drugs aimed at diseases that afflict small groups, typically under 200,000 people. Marathon sought and <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm540945.htm">won approval</a> for Emflaza under ODA provisions.</p>
<p>As health economists who study drug pricing, we see an opportunity for change.</p>
<h2>Even great ideas sometimes go awry</h2>
<p>The ODA contains a powerful inducement for pharmaceutical firms: New treatments for rare diseases earn <a href="https://www.fda.gov/downloads/drugs/developmentapprovalprocess/smallbusinessassistance/ucm447307.pdf">seven years of market exclusivity</a>, including protection from imports. That means the companies can price without fear of competition and sell to dependent populations. It also means patients with rare diseases have some hope that their conditions are not neglected.</p>
<p>However, the nature of drug development has changed. The number of requests for orphan designation <a href="https://docs.google.com/viewer?url=http%3A%2F%2Fwww.fda.gov%2Fdownloads%2FAboutFDA%2FReportsManualsForms%2FReports%2FBudgetReports%2FUCM488554.pdf">has quadrupled since 2000.</a> The result has been a boom in drug sales and profits. The average price of an orphan drug exceeds <a href="https://www.statista.com/statistics/373353/average-cost-for-orphan-drugs-per-patient-per-year/">$100,000 a year.</a> Orphan drugs now make up <a href="http://www.nature.com/nrd/journal/v11/n4/full/nrd3654.html">one in three drugs approved by the FDA.</a> Sales of orphan drugs rose 12 percent in 2016 to $114 billion, compared to a rise of <a href="https://www.statnews.com/pharmalot/2017/02/28/orphan-drugs-prices/">2.4 percent for all other branded drugs to $578 billion.</a></p>
<p>Some of the drugs developed under the ODA are lifesaving, and many are cost-effective. But over the years many other drugs, such as Emflaza, have won ODA status even if they are not new or represent a scientific breakthrough.</p>
<p>For example, a cheap off-patent drug approved by the FDA for one condition, but widely prescribed as an “off-label” treatment for an orphan disease, can be transformed into a big moneymaker. By putting the drug through clinical trials to document its safety and effectiveness, a pharmaceutical company can gain FDA approval for use on the disease. The accompanying seven years of monopoly status can mean large price hikes for a drug that was already in wide use.</p>
<p>Insurers are usually stuck with the bill, but – as should be clear to everyone by now – these costs get passed to consumers via higher premiums.</p>
<p>Even though Emflaza’s price tag is relatively small compared to many orphan drugs (Biogen introduced a <a href="http://www.xconomy.com/boston/2016/12/28/biogen-sets-750000-initial-price-for-first-ever-spinal-atrophy-drug/">$750,000 drug</a> to treat spinal muscular atrophy in December), it seemed to hit a nerve. In February, <a href="http://www.npr.org/sections/health-shots/2017/03/07/518980280/gop-senators-ask-gao-to-investigate-high-prices-for-orphan-drugs">Sen. Chuck Grassley (R-Iowa)</a>, the chairman of the Senate Judiciary Committee, announced that he will convene a formal inquiry into potential abuses of the Orphan Drug Act.</p>
<h2>What to do?</h2>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/160600/original/image-20170313-9637-1so79hm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/160600/original/image-20170313-9637-1so79hm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=399&fit=crop&dpr=1 600w, https://images.theconversation.com/files/160600/original/image-20170313-9637-1so79hm.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=399&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/160600/original/image-20170313-9637-1so79hm.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=399&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/160600/original/image-20170313-9637-1so79hm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=501&fit=crop&dpr=1 754w, https://images.theconversation.com/files/160600/original/image-20170313-9637-1so79hm.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=501&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/160600/original/image-20170313-9637-1so79hm.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">
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<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/many-white-drugs-pills-shapes-outside-170390432">from shutterstock.com</a></span>
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<p>The first reaction is to call for government price setting. But this is not just a public payer issue, and the government doesn’t set prices in the private insurance plans. </p>
<p>In addition, in some ways the ODA is doing what it was designed to do: Offer temporary monopolies as an incentive for drug discovery. The FDA could factor pricing into its decision-making, but this is a slippery slope for an agency that has never explicitly factored prices into review.</p>
<p>Something could be done, though. </p>
<p>On the access side, patients with these diseases are costly to society, but their care is valued. This means patients with rare diseases should have guaranteed access to high-risk insurance pools – an issue of some importance in the current Obamacare replacement debate – and these high-risk pools cannot skimp on orphan coverage. </p>
<p>On the pricing side, private insurers haven’t scrutinized these orphan products enough. Traditionally, it wasn’t worth the insurers’ time. While prices are high, the total costs are small when spread over the entire population, and the patient communities are vocal. (In the Duchenne example, <a href="http://www.cnbc.com/2017/02/13/reuters-america-update-1-marathon-pauses-duchenne-drug-launch-amid-price-outcry.html">only about 800 patients receive the drug currently</a>.)</p>
<p>But the world is changing. Advances in personalized medicine and genomics also demand change. We now face the prospect that more common treatments – like cancer vaccines – could be custom designed for each patient, and that these will be reflected in even more orphan applications. </p>
<p>Insurers need to hold the line with manufacturers, and make them accountable to offer <a href="http://healthaffairs.org/blog/2015/04/28/its-time-for-value-based-payment-in-oncology/">value-based prices for all products</a>, including orphan drugs. The FDA can help by insisting manufacturers collect rigorous and complete post-market surveillance data about how patients fare after taking orphans – across all payers, private and public. </p>
<p>We have the tools to deal with this problem. We just need to start using them.</p><img src="https://counter.theconversation.com/content/74144/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dana Goldman is a founder and owns equity in Precision Health Economics, a health care consultancy which provides services to the life sciences industry, including some companies with orphan drugs.</span></em></p><p class="fine-print"><em><span>Jay Bhattacharya 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>The Orphan Drug Act was enacted 34 years ago to encourage the development of drugs for rare diseases. Drug companies were guaranteed seven years of exclusivity. Then the rush was on to run up prices.Dana Goldman, Director, Leonard D. Schaeffer Center for Health Policy & Economics, University of Southern CaliforniaJay Bhattacharya, Professor of Medicine, Stanford UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/613642016-06-23T02:02:00Z2016-06-23T02:02:00ZDrug companies are buying doctors – for as little as a $16 meal<figure><img src="https://images.theconversation.com/files/127695/original/image-20160622-19764-ew0bis.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Even cheap dinners were found to influence prescribing habits.</span> <span class="attribution"><span class="source">from www.shutterstock.com.au</span></span></figcaption></figure><p><a href="http://archinte.jamanetwork.com/article.aspx?articleid=2528290">An important new study</a> in the United States has found doctors who receive just one cheap meal from a drug company tend to prescribe a lot more of that company’s products. The damming findings demonstrate the value of new transparency laws in the US, and remind Australians we’re still very much in the dark about what our doctors get up to behind closed doors.</p>
<p>Just published in the leading Journal of the American Medical Association (JAMA) Internal Medicine, this study is well worth a look for anyone interested in the hidden influences on how doctors prescribe. </p>
<p>Together with a host of other recent work, it adds to the growing mountain of evidence suggesting doctors who expose themselves to marketing strategies – from seeing attractive drug reps to attending sponsored “education” – are doing patients and the wider public a grave disservice. </p>
<h2>Need for transparency</h2>
<p>The new study took advantage of a new government-run and <a href="https://openpaymentsdata.cms.gov/search">publicly available database</a> which discloses all drug company payments to doctors. Researchers looked at how often doctors prescribed four popular brand-name drugs, and linked prescribing rates to how often those doctors received meals from the drugs’ manufacturer.</p>
<p>They found that receiving just one company-funded meal was associated with a 20% increase in prescribing of Astra Zeneca’s cholesterol-lowering statin, Crestor, compared to other drugs in the same class. </p>
<p>For two other heart drugs, the increase was in the order of 50%. For Pfizer’s anti-depressant Pristiq, taking one free meal was linked to a 100% increase, or a doubling of the rate of prescriptions. </p>
<p>The average cost of the meals drug companies gave these doctors was between US$12 (A$16) and US$18 ($A24).</p>
<p>And when doctors ate sponsored meals on more than four occasions, their prescribing of the brand-name drugs rose dramatically. Perhaps unsurprisingly, doctors who got more expensive meals tended to have bigger prescribing increases.</p>
<h2>Association not cause and effect</h2>
<p>Perhaps the most important caveat, as the study’s authors stressed, is that “the findings represent an association – not a cause and effect relationship”. Nevertheless, the results reinforce similar findings from recent studies also using the new transparency data in the US.</p>
<p>In March investigative journalists at <a href="https://www.propublica.org/article/doctors-who-take-company-cash-tend-to-prescribe-more-brand-name-drugs">ProPublica</a> found doctors who received drug company payments or gifts – mostly free meals – wrote scripts for brand-name drugs at much higher rates compared to doctors who didn’t take industry money.</p>
<p>In May, in the <a href="http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0155474">journal PLOS One</a>, researchers found almost half of the 700,000 doctors in the US had received payments from drug companies. Specialties receiving the highest industry payments had the highest prescribing costs per patient.</p>
<p>And also in May, the <a href="http://archinte.jamanetwork.com/article.aspx?articleid=2520680">JAMA Internal Medicine</a> published a small study from the state of Massachusetts, similarly uncovering an association between payments from industry and modest increases in rates of prescribing brand-name statins (cholesterol-lowering medication).</p>
<h2>So why does this matter?</h2>
<p>The main concern in all the recent US studies is the unnecessary cost to patients and the health system when brand-name drugs are prescribed instead of cheaper generic alternatives. </p>
<p>But perhaps the more serious concern is the danger of doctors prescribing under the influence of drug company marketing – which always favours the latest new drug, rather than what’s in the patient’s best interest.</p>
<p>As <a href="https://theconversation.com/we-cant-trust-drug-companies-to-wine-dine-and-educate-doctors-about-the-drugs-they-prescribe-56990">The Conversation</a> has covered recently, newer and aggressively promoted drugs can have very limited advantages over older ones, if any, and sometimes carry very serious side effects – particularly for the elderly. </p>
<p>There is already evidence many older Australians are at risk of harm from taking too many inappropriate medicines – and <a href="https://www.mja.com.au/journal/2014/201/7/first-do-no-harm-real-need-deprescribe-older-patients">there is a growing push</a> to promote “de-prescribing”, which means taking people off drugs they don’t need. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/127697/original/image-20160622-19780-1dsy3gw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/127697/original/image-20160622-19780-1dsy3gw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/127697/original/image-20160622-19780-1dsy3gw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=360&fit=crop&dpr=1 600w, https://images.theconversation.com/files/127697/original/image-20160622-19780-1dsy3gw.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=360&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/127697/original/image-20160622-19780-1dsy3gw.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=360&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/127697/original/image-20160622-19780-1dsy3gw.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=453&fit=crop&dpr=1 754w, https://images.theconversation.com/files/127697/original/image-20160622-19780-1dsy3gw.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=453&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/127697/original/image-20160622-19780-1dsy3gw.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=453&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 companies often promote new and expensive drugs – and they’re not always the ones in the patient’s best interest.</span>
<span class="attribution"><span class="source">from www.shutterstock.com</span></span>
</figcaption>
</figure>
<h2>Australia still in dark</h2>
<p>Compared to the new transparency regime in the US, Australia has fallen way behind. Under <a href="https://medicinesaustralia.com.au/wp-content/uploads/sites/52/2010/01/20140812-detailed-summary-of-amendments-Code-Ed-18_.pdf">new rules</a> some payments to some individual doctors will have to be disclosed from this August, but there are too many loopholes.</p>
<p>As a result of horse trading about the new rules – between the doctors, the drug companies and public authorities – any funding of meals costing less that A$120 will not have to be disclosed. And if doctors who have received payments don’t want their names disclosed in August, they won’t be. </p>
<p>Also, all of the roughly 25,000 events, including breakfasts, lunches and dinners which doctors and other health professionals regularly attend annually, will from now on remain totally secret – until there is regulatory reform. </p>
<p>Consumer groups are angry that citizens remain in the dark, and many doctors are horrified by the wining and dining of their colleagues, with <a href="https://theconversation.com/why-i-dont-see-drug-reps-a-gps-take-on-big-pharma-spruiking-32435">some cutting their ties</a>: refusing to see the attractive sales reps and seeking “education” elsewhere. </p>
<h2>Disclosure on its own is no panacea</h2>
<p><a href="https://theconversation.com/forget-tea-and-biscuits-why-should-doctors-get-any-gifts-from-pharma-companies-18752">As others have pointed out</a>, disclosure on its own is not a panacea, and it’s legitimate to ask why doctors should receive any free gifts or meals at all. </p>
<p>Already there’s been <a href="https://theconversation.com/pharma-payments-to-doctors-stay-behind-closed-doors-for-now-15279">one legislative attempt</a> to enforce more independence between doctors and drug companies in Australia, and it is likely more will emerge in the future.</p>
<p>Until then, it might be wise to inquire whether your doctor still takes the free meals – and perhaps seek your care elsewhere if the answer is yes.</p><img src="https://counter.theconversation.com/content/61364/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dr Ray Moynihan is a chief investigator within the NHMRC funded Wiser Health Care research collaboration, and has had a long time interest in writing about and researching interactions between industry and health professions. </span></em></p>An important new study in the United States has found doctors who receive just one cheap meal from a drug company tend to prescribe a lot more of that company’s products.Ray Moynihan, Senior Research Fellow, Bond UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/569902016-04-06T20:12:32Z2016-04-06T20:12:32ZWe can’t trust drug companies to wine, dine and educate doctors about the drugs they prescribe<figure><img src="https://images.theconversation.com/files/117581/original/image-20160406-28970-1pjczsx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Medicines drug companies peddle as safe aren't always. </span> <span class="attribution"><span class="source">from www.shutterstock.com.au</span></span></figcaption></figure><p>If a drug company treats a doctor to a nice lunch and a presentation on their newest products, is prescribing affected? Doctors generally think not, but the <a href="http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1000352">research evidence</a> overwhelmingly says yes. And if these events do affect doctors’ decisions on patient care, should we be worried? </p>
<p>An <a href="http://www.smh.com.au/national/health/pharmaceutical-companies-splash-43-million-on-health-professionals-in-six-months-20160329-gnsy45.html">exposé</a> last week described over A$43 million worth of industry spending on health professionals in Australia over just six months. This included big-ticket items such as a “A$176,000 junket to Vancouver for nine dermatologists”.</p>
<p>The response, unsurprisingly, is divided. The Australian Medical Association’s president <a href="http://www.smh.com.au/national/health/pharmaceutical-companies-splash-43-million-on-health-professionals-in-six-months-20160329-gnsy45.html">describes</a> industry-sponsored educational events as “in the best interest of patients”. Medicines Australia, the industry trade association, defends the industry’s role <a href="http://www.smh.com.au/national/health/pharmaceutical-companies-splash-43-million-on-health-professionals-in-six-months-20160329-gnsy45.html">because</a>: “No one knows medicines as well as those who make them”. </p>
<p>On the other hand, the Consumer Health Forum <a href="http://www.smh.com.au/national/health/pharmaceutical-companies-splash-43-million-on-health-professionals-in-six-months-20160329-gnsy45.html">raises concerns</a> that such industry largesse may lead to prescribing that is “…not in the best interests of patients”. </p>
<h2>What the research says</h2>
<p>A <a href="https://www.propublica.org/article/doctors-who-take-company-cash-tend-to-prescribe-more-brand-name-drugs">study</a> by investigative journalism group Pro Publica released in March provides important insights into the influence of industry payments on prescribing. The study combined reports of payments to doctors under the US Sunshine Act with prescribing records. </p>
<p>The more money doctors received, the more brand-name drugs they prescribed. Those who were paid to speak at conferences or sponsored events prescribed more brand-name drugs than those just getting free meals. </p>
<p>Newer, on-patent, brand-name drugs are overwhelmingly the medicines that companies actively promote. And whether patients pay for medicines themselves or have them covered by a public or private insurance, less expensive, equally effective alternatives are often available. </p>
<p>Beyond the higher price, rapid uptake of new medicines is often not in patients’ best interest. When a medicine is first approved, little is known about rare or longer-term harmful effects. Serious harmful effects often become known during the first few years of use. Older people, and those with several serious health conditions, are usually not included in pre-market studies. </p>
<p>This happened with dabigatran (Pradaxa), an anticoagulant that was used to prevent stroke. Despite lack of pre-market testing in people over 85, it was soon commonly prescribed to this age group. Older, frail people are at higher risk of bleeding, a harmful drug side-effect, and dabigatran rapidly became a leading cause of <a href="https://www.tga.gov.au/alert/dabigatran-pradaxa-and-risk-bleeding-information-health-professionals">reports to regulators</a> of life-threatening bleeds. </p>
<p>We expect newer products to be better than the ones they replace. But this is not a requirement for a new medicine to be approved. The manufacturer needs only to show effects compared to a placebo or “sugar pill”. Many new medicines are no better or even worse than existing treatments. </p>
<p><a href="http://english.prescrire.org/en/Summary.aspx">Prescrire International</a>, a French independent bulletin, evaluates every new medicine. Over the past ten years, it found that only 7% of 1,035 offered even modest treatment advantages. More than twice as many were less safe or effective than existing options. Most of the rest were no better or worse. </p>
<p>Doctors get a very different message in drug promotion. Colleagues in Canada, the United States, France and I <a href="http://www.ncbi.nlm.nih.gov/pubmed/23558775">studied the safety information</a> doctors get from sales representatives. More than 250 doctors participated in the study, reporting on nearly 1,700 drug-specific promotions during sales visits. </p>
<p>Fewer than 2% of promotions included “minimally adequate” information for safe prescribing in any of the three countries. </p>
<p>We carried out this study just before the use of the diabetes drug rosiglitazone (Avandia) was restricted due to heart attack risks. Nearly all of the promotional claims were of safety: “Avandia is safe even in patients with heart disease”; “new studies indicate safety”. </p>
<h2>What about ‘educational events’?</h2>
<p>There are many reports of educational events also leading to bias in documents that have become public in US legal cases on fraudulent marketing. For example, sponsored education was a major tactic used by Parke-Davis to promote the epilepsy drug <a href="http://www.ncbi.nlm.nih.gov/pubmed/16908919">gabapentin (Neurontin)</a> for a range of unapproved uses. </p>
<p>And it is hard to see a <a href="http://ajmf.org.au/wp-content/uploads/2014/07/AJMF-VIC-Aug-2014-meeting-Kimberly-Gardens2.pdf">dinner event</a> on “The Anxious, Depressed Patient”, sponsored by AstraZeneca in August 2014 at Kimberly Gardens in St Kilda, as anything but promotional when the invitation features the same image as an advertisement for quetiapine (Seroquel).</p>
<p>Such events often feature physician “key opinion leaders”. This is one of the most insidious forms of promotion, as it’s harder for the audience to clearly see that this is sales. </p>
<p>A first step towards change would be a firewall between continuing professional education and industry sponsorship. Australian doctors can access excellent independent medicines information through <a href="http://www.nps.org.au/">NPSMedicineWise</a>, the <a href="https://shop.amh.net.au/">Australian Medicines Handbook</a> and <a href="http://www.tg.org.au/">Therapeutic Guidelines</a>. Funding for independent continuing professional education could also be expanded. </p>
<p>The view of many doctors that “I don’t let myself be influenced” might be the biggest barrier to change. But A$43 million in six months is a lot of money for drug companies to spend if they’re having no influence.</p><img src="https://counter.theconversation.com/content/56990/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Barbara Mintzes has received funding from the Canadian Institutes of Health Research for research on drug promotion. She has also acted as an expert witness on behalf of plaintiffs in Canadian class action lawsuits on hormone replacement therapy and testosterone. She is affiliated with the Therapeutics Initiative, an independent research group that provides an information bulletin for doctors and pharmacists, and Health Action International, a global consumer network working to promote more rational use of medicines. </span></em></p>The view of many doctors that “I don’t let myself be influenced” might be the biggest barrier to change.Barbara Mintzes, Senior Lecturer, Faculty of Pharmacy, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/570612016-04-06T20:12:13Z2016-04-06T20:12:13ZInvisible influence: why sales reps are forming relationships with nurses<figure><img src="https://images.theconversation.com/files/117614/original/image-20160406-28973-rdbdkk.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Nurses do influence decisions on which medical products and equipment to buy.</span> <span class="attribution"><span class="source">from www.shutterstock.com.au</span></span></figcaption></figure><p>Last week Fairfax Media <a href="http://theconversation.com/we-cant-rely-on-drug-companies-to-wine-dine-and-educate-doctors-about-the-drugs-they-prescribe-56990">revealed</a> pharmaceutical companies are spending lavish amounts treating Australian doctors to lunches, dinners and overseas trips.</p>
<p>However, it is not only doctors who are courted in this way. The <a href="http://www.smh.com.au/national/health/pharmaceutical-companies-splash-43-million-on-health-professionals-in-six-months-20160329-gnsy45.html">article</a> reported that Pfizer Australia paid A$56,628 to send four endocrinology nurses to Savannah, Georgia, for a two-day conference.</p>
<p>Globally, countries are adopting regulation that aims to bring transparency to the financial relationships between doctors and pharmaceutical and medical device companies. These <a href="http://www.pewtrusts.org/en/research-and-analysis/fact-sheets/2013/11/11/persuading-the-prescribers-pharmaceutical-industry-marketing-and-its-influence-on-physicians-and-patients">relationships are associated</a> with the increased prescription of high-cost, brand-name drugs and devices that often have a limited track record for safety. </p>
<p>However, when policymakers and researchers discuss marketing to health professionals, the relationships between nurses and industry are seldom considered. And these relationships remain almost entirely invisible to the public.</p>
<h2>Nurses have more influence than most think</h2>
<p>As doctors’ relationships with industry come under public scrutiny, researchers suggest nurses are increasingly becoming a <a href="http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0050005">“soft” target</a> for marketing and a regulatory “back door” to prescribers and patients. </p>
<p>This could mean that efforts to protect clinical decision-making from marketing influence are undermined, potentially driving up health-care costs or exposing patients to unnecessary or even unsafe treatments.</p>
<p>Australia is one of the few countries where payments and gifts to nurses are reported. A <a href="http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1000128">2009 study</a> found that Australian pharmaceutical companies sponsored almost 600 educational events for health professionals a week at a cost of about A$1 million per week. Nurses were present at 26% of these events – nearly as often as family doctors.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/117584/original/image-20160406-28973-13ksksu.png?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/117584/original/image-20160406-28973-13ksksu.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/117584/original/image-20160406-28973-13ksksu.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=246&fit=crop&dpr=1 600w, https://images.theconversation.com/files/117584/original/image-20160406-28973-13ksksu.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=246&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/117584/original/image-20160406-28973-13ksksu.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=246&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/117584/original/image-20160406-28973-13ksksu.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=309&fit=crop&dpr=1 754w, https://images.theconversation.com/files/117584/original/image-20160406-28973-13ksksu.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=309&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/117584/original/image-20160406-28973-13ksksu.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=309&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">A medical trade show.</span>
<span class="attribution"><span class="license">Author provided</span></span>
</figcaption>
</figure>
<p>Yet, many wonder, if nurses cannot prescribe treatments, why would companies spend money marketing to them?</p>
<p>Our <a href="http://annals.org/article.aspx?articleID=2511011">new study</a> paints a preliminary picture of the routine yet influential ways registered nurses interact with sales representatives in day-to-day clinical practice. </p>
<p>We explored why policymakers have overlooked marketing to nurses. This involves deeply held assumptions about the nature of nurses’ work – namely, that because nurses do not prescribe, they have no influence on treatment decisions. Thus, interactions between nurses and industry are subject to little scrutiny. </p>
<p>We interviewed and observed registered nurses working in four acute care hospitals in the United States who interacted with sales representatives from the “medically related industry”. This consisted of pharmaceutical, medical device and equipment, nutrition and infant formula, and health technology companies.</p>
<p>Nurses interacted with industry in similar ways to doctors. They attended sponsored dinners, served as paid speakers for companies, met one-on-one with sales representatives and were offered free samples or small gifts. </p>
<p>But nurses also described daily contact with industry in the course of patient care. This included in-service education conducted by sales representatives, sales representatives providing product support in the operating theatre or presenting product information to purchasing committees. </p>
<p>For example, when hospitals purchase medical equipment, they often contract the company to have a sales representative teach the nursing staff how to use it. As product experts, sales representatives are an obvious source of product information. </p>
<p>However, nurses in the study described the challenges of keeping sales representatives “on message”. They struggled to identify biased information and with “upselling” when sales representatives tried to introduce related or upgraded products. </p>
<p>Participants in the study, including staff nurses up to hospital administrators, echoed the general assumption that nurses who do not prescribe have little control over treatment decisions. Thus, marketing directed to them is seen as being of little consequence to patients or the health system. </p>
<p>Hospital administrators asserted that nurses did not normally interact with industry at all. Nurses wondered “why they invite us” to sponsored drug dinners. </p>
<p>At the same time, nurses offered many examples of instances where they had influence over treatment and purchasing decisions.</p>
<h2>Policies need to include nurses</h2>
<p>Nurses frequently influence treatment decisions through recommending medications to patients and prescribers, as well as providing feedback on treatment outcomes. They play a vital role in medication adherence, ensuring that patients can fill and refill their medications. </p>
<p>Nurse managers oversee large departmental operating budgets. They play key roles in researching, evaluating and selecting the medical products, devices and equipment a hospital must purchase. </p>
<p>Nurses in the United States and Australia have a similar scope of practice. Similarly, the sales representatives nurses encountered in this study worked for multinational companies. Thus, Australian nurses may be subject to similar interactions and marketing influence. </p>
<p>As policymakers, researchers and the public focus on physicians, nurses increasingly interact with sales representatives on a daily basis and may be susceptible to marketing influence. </p>
<p>By forming relationships with nurses, the for-profit medically related industry gains “behind the scenes” access to and influence over health-care decisions. </p>
<p>To protect clinical decision-making from marketing influence, nurses’ power and expertise must be recognised. That means policies must include the disclosure and management of nurses’ relationships with industry.</p><img src="https://counter.theconversation.com/content/57061/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Quinn Grundy received funding from the United States Agency for Healthcare Research and Quality (AHRQ) and the Canadian Institutes of Health Research (CIHR). </span></em></p>Just because they can’t prescribe medications that does not mean nurses have no influence on important decisions for patient care.Quinn Grundy, Postdoctoral Fellow, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/464152015-08-20T23:27:02Z2015-08-20T23:27:02ZDespite the headlines, dementia epidemic may not actually be getting worse<figure><img src="https://images.theconversation.com/files/92560/original/image-20150820-7228-1uv9y76.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The future may not be as bleak as we thought</span> <span class="attribution"><a class="source" href="http://www.shutterstock.com/s/dementia/search.html?page=4&thumb_size=mosaic&inline=292977260">Ocskay Mark</a></span></figcaption></figure><p>The notion of a <a href="http://www.reuters.com/article/2013/12/05/us-dementia-global-idUSBRE9B400G20131205">dementia epidemic</a> has been a big concern in ageing societies across the globe for some time. With the extension of life expectancy it seems to be an inevitable disaster – one of the “greatest enemies of humanity”, <a href="http://www.bbc.co.uk/news/health-27912473">according to</a> UK prime minister David Cameron. </p>
<p>Many shocking figures <a href="http://www.alz.co.uk/research/G8-policy-brief">have been published</a> pointing to dramatic increases in dementia prevalence and massive predicted costs and burdens. Yet new evidence seems to suggest otherwise. In <a href="http://press.thelancet.com/dementia.pdf">a review</a> of dementia occurrence in five studies in the UK, Sweden, Spain and the Netherlands between 2007 and 2013 that used consistent research methods and diagnostic criteria, we found none that supported headlines about dramatic increases in dementia. They report stable or reduced prevalence at specific ages over the past few decades – despite ageing populations. </p>
<p>How to reconcile this relatively optimistic picture with what looks like panic on the part of governments, charities and the mainstream media? One reason is that they fail to recognise the complexity of dementia diagnosis. The main criteria for diagnosing dementia hinge on cognitive decline and an associated deterioration in a person’s ability to carry out day-to-day activities. If there are variations in the recognised boundaries of these criteria either in different countries or during different time periods, this can affect occurrence estimates without changing the fundamentals of the dementia syndrome itself. </p>
<p>Over the past few decades, the diagnostic criteria have indeed changed across the world in parallel with public awareness and perceptions. More people are now diagnosed with very early dementia, for example, though it <a href="http://www.ncbi.nlm.nih.gov/pubmed/19236314">may or may not</a> progress into more severe forms. The introduction of biomarkers for diagnosis is likely to further expand prevalence by identifying large sections of populations at risk – and <a href="http://www.alz.org/research/science/earlier_alzheimers_diagnosis.asp#Brain">is already</a> in its early stages. Such changes will affect different groups of people in different contexts in different ways, but basically we might be counting more people as having dementia due to the use of more inclusive diagnostic criteria. </p>
<h2>Solution and salvation</h2>
<p>Having said that, there might be more than careless use of research evidence at play. The worsening epidemic message also fits well with consumer psychology and the recent history of over-medicalisation: fear, demand for a solution, and salvation. The world is looking for a silver bullet. Since the G8 summit of 2013, the hunt for “a dementia cure or disease-modifying therapy by 2025” <a href="https://www.gov.uk/government/news/uk-commits-to-new-action-to-find-breakthrough-on-dementia">has become</a> a global target. We have seen major investment from public and private funding bodies alike, stimulating national and even global collaborations. Current research has focused on drug interventions and clinical trials, <a href="http://www.alz.org/research/science/earlier_alzheimers_diagnosis.asp#Brain">as well as</a> relevant biomarkers including novel imaging for assumed brain pathology. </p>
<p>The progress to date has not been promising, but the reality is that healthcare and pharmaceutical companies are looking at large potential profits from future dementia interventions. It makes sense for them to play up the possibility of avoiding conditions associated with ageing, both now and in future. It would be particularly lucrative for them to be able to recommend specific medications for younger people who had been found to have a higher risk of developing dementia later in life. Such treatments could enjoy far wider demand than a specific targeted cure for the smaller group who are already developing the condition. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/92561/original/image-20150820-7225-26cafb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/92561/original/image-20150820-7225-26cafb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/92561/original/image-20150820-7225-26cafb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/92561/original/image-20150820-7225-26cafb.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/92561/original/image-20150820-7225-26cafb.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/92561/original/image-20150820-7225-26cafb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/92561/original/image-20150820-7225-26cafb.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/92561/original/image-20150820-7225-26cafb.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">Safe from pharm?</span>
<span class="attribution"><a class="source" href="http://www.shutterstock.com/s/dementia/search.html?page=3&thumb_size=mosaic&inline=300566165">masic0553</a></span>
</figcaption>
</figure>
<p>But if dementia prevalence is indeed stable or even declining, might past policies provide a better answer? Remember we are talking about a generation which experienced substantial post-war investments in education and socialised healthcare, and a partial reduction in social inequalities as a result. If it has worked thus far, the same kind of approach might be the best way forward for the future. Adopting a drug-only approach is likely to lead to widening inequalities of access and problems with affordability, as we learned with HIV/AIDS, cancer and other diseases. </p>
<p>The <a href="http://www.nhs.uk/conditions/dementia-guide/pages/dementia-prevention.aspx">current dementia prevention advice</a> focuses on what people can do in terms of healthy behaviour and lifestyle: exercise, diet and so forth. Yet our lifestyles and health are considerably influenced by factors in our wider social environment over which we have limited control. For the sake of future populations, this is why responsibility for dementia prevention should be seen as a matter for society and the world as a whole.</p><img src="https://counter.theconversation.com/content/46415/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Yu-Tzu Wu received a PhD scholarship from Cambridge Trust</span></em></p><p class="fine-print"><em><span>Carol is co-chair of the research advisory council of the Alzheimer's society. She receives funding from the MRC (Cognitive Function and Ageing Study(CFAS)).</span></em></p>Five new European studies say dementia occurrence is stable or falling. Our panic may have been unnecessary.Yu-Tzu Wu, Epidemiology, University of CambridgeCarol Brayne, Professor of Public Health Medicine, University of CambridgeLicensed as Creative Commons – attribution, no derivatives.