tag:theconversation.com,2011:/global/topics/pharmaceutical-industry-20029/articlesPharmaceutical industry – The Conversation2024-03-14T19:24:28Ztag:theconversation.com,2011:article/2254572024-03-14T19:24:28Z2024-03-14T19:24:28ZNZ’s new disclosure scheme for pharma payments to doctors falls short of best practice<figure><img src="https://images.theconversation.com/files/581495/original/file-20240313-28-ktn1tc.jpg?ixlib=rb-1.1.0&rect=60%2C222%2C6679%2C4173&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">Getty Images</span></span></figcaption></figure><p>Pharmaceutical industry payments to doctors are common, often substantial and can affect clinical decision making. </p>
<p>Seven years after the industry trade association Medicines New Zealand first <a href="https://www.stuff.co.nz/national/71926518/new-zealand-health-workers-accept-hundreds-of-thousands-of-dollars-worth-of-drug-company-gifts">mooted a disclosure system</a>, pharmaceutical companies operating in New Zealand recently revealed their <a href="https://www.stuff.co.nz/national/health/131175559/under-the-influence-inside-new-zealands-first-disclosure-of-drug-company-payments-to-health-professionals">financial relationships with individual doctors</a> for the first time. </p>
<p>This included disclosure of payments for speaking engagements, consultancies, advisory board memberships, travel costs, attendance at conferences and other sponsored events. </p>
<p>In the absence of relevant legislation, this is a welcome, albeit incomplete, development. It includes only members of Medicines New Zealand, representing less than half the pharmaceutical companies operating in the country. Some member companies did not participate and several payment types (hospitality, conference sponsorship and research funding) were omitted.</p>
<p>Our new <a href="https://www.bmj.com/content/384/bmj-2023-078133.full?ijkey=GoBiOaqsuNpQQ4G&keytype=ref">research</a> analyses international evidence and concludes that such payments should be subject to mandatory, comprehensive and accessible disclosure.</p>
<h2>Why drug company payments are a problem</h2>
<p>Accumulating evidence shows pharmaceutical company payments to doctors <a href="https://www.acpjournals.org/doi/abs/10.7326/M20-5665">influence prescribing</a> and other aspects of healthcare, including research and teaching. The deadly opioid epidemic in the US, for example, has been <a href="https://link.springer.com/article/10.1007/s11673-020-09982-x">linked to excessive prescribing</a> resulting from industry promotion. </p>
<p>It may sound like a good thing to have medical experts advising industry about the optimal use of medicines. But receiving payments for such advice has been associated with <a href="https://academic.oup.com/oncolo/article/24/5/632/6439174">impressive increases in prescribing</a> of the sponsor’s product(s). </p>
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<img alt="A man handing a prescription to a pharmacists" src="https://images.theconversation.com/files/581775/original/file-20240313-16-d09lmt.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/581775/original/file-20240313-16-d09lmt.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/581775/original/file-20240313-16-d09lmt.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/581775/original/file-20240313-16-d09lmt.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/581775/original/file-20240313-16-d09lmt.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/581775/original/file-20240313-16-d09lmt.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/581775/original/file-20240313-16-d09lmt.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">Pharmaceutical company payments to doctors are linked with increased prescribing of promoted medicines.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com.au/detail/photo/prescription-royalty-free-image/171296967?phrase=medicine+prescription&adppopup=true">Getty Images</a></span>
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<p>Beyond stimulating the prescription of particular drugs, such payments have been associated with the <a href="https://onlinelibrary.wiley.com/doi/abs/10.1111/jlme.12073">distortion of clinical guidelines</a> by influential doctors. This affects medical practice and can result in overdiagnosis, overtreatment and treatment-related harm. </p>
<p>Since pharmaceutical promotion typically focuses on newer, branded medications, an increase in prescriptions is also linked with rising health costs.</p>
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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>
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<h2>Attempts at regulation</h2>
<p>Because of the above concerns, coupled with health professionals’ tendency to favour transparency in principle, disclosure of payments now occurs in most high-income countries. </p>
<p>However, reporting standards for industry payments vary widely, as we discovered when surveying the international evidence.</p>
<p>Court cases in the US have led to billion-dollar fines for illegal pharmaceutical marketing by various <a href="https://www.citizen.org/article/twenty-seven-years-of-pharmaceutical-industry-criminal-and-civil-penalties-1991-through-2017/">companies</a>. The resulting US <a href="https://www.advamed.org/our-work/policy-areas/legal/physician-payments-sunshine-act/">Sunshine Act 2010</a> is the most comprehensive legislative requirement to date for reporting payments to health professionals. </p>
<p>Some European countries and South Korea also legislate disclosure requirements. By contrast, other European countries as well as the UK, Australia, New Zealand, Canada and Japan rely on industry to do this. </p>
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<p>Accessibility is an important aspect of disclosure. Currently in New Zealand, a patient would need to search company reports separately to discover how much funding their doctor may have received from pharmaceutical firms marketing medicines they are prescribed. </p>
<p>By contrast, the database mandated by the US Sunshine Act includes all companies and details on whether payments to individual doctors are related to one or more of their products. </p>
<p>Apart from providing patients with easily accessible information about payments received by their doctor, this resource has enabled researchers to document the extensive connections between doctors’ payments and prescribing.</p>
<p>Our analysis indicates that industrial gift giving to doctors is also prominent in low and middle-income countries. Provision of drug samples and support to attend educational events are comparable to the Global North, but typically without disclosure requirements. </p>
<p><a href="https://link.springer.com/article/10.1186/s12913-019-3887-6">Studies</a> in Global South countries suggest doctors receive a broader range of gifts not typically seen in wealthier countries. This can include cash, office supplies, cars, personal travel, domestic cattle, and sexual “favours”.</p>
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<img alt="Chemist examining different medicines." src="https://images.theconversation.com/files/581790/original/file-20240313-16-d3vv52.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/581790/original/file-20240313-16-d3vv52.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/581790/original/file-20240313-16-d3vv52.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/581790/original/file-20240313-16-d3vv52.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/581790/original/file-20240313-16-d3vv52.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/581790/original/file-20240313-16-d3vv52.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/581790/original/file-20240313-16-d3vv52.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">The pharmaceutical industry typically promotes newer, branded medications, which tend to be more expensive.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com.au/detail/photo/female-pharmacist-checking-medicines-on-rack-royalty-free-image/1077578330?phrase=drug+companies&adppopup=true">Getty Images</a></span>
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<h2>Arguments in favour of the status quo</h2>
<p>Some pundits have vigorously defended the benefits of doctors interacting with industry. Others have highlighted the administrative burden and uncertain efficacy of enforcing disclosure requirements. </p>
<p>Retaining industry funding for medical education, especially in the Global South, is seen by some as a priority because of resource limitations. But this rationale needs to be balanced against the typical industry focus on a limited range of topics, the inability of many doctors to perceive bias in industry-funded education, and the potential harm from shifting scarce resources to expensive branded products.</p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/canadians-need-to-know-how-much-money-big-pharma-gives-health-care-providers-but-this-information-is-far-too-difficult-to-find-225066">Canadians need to know how much money Big Pharma gives health-care providers, but this information is far too difficult to find</a>
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<p>As with other payment reporting schemes led by industry, New Zealand’s system falls short of international best practice, both in terms of completeness and ease of access. Worse, it is less comprehensive than many other schemes, with member companies choosing whether to report and recipient doctors able to opt out of disclosure. </p>
<p>Given its relatively late appearance internationally, we had hoped that Medicines New Zealand would implement a disclosure regime reflecting international best practice. Instead, it has chosen a system which is both limited and cumbersome to use, from the standpoint of both patients and researchers.</p>
<h2>Next steps</h2>
<p>Implementing best practice is a substantial challenge, considering different political systems and anticipated pushback from industry and others who benefit from weak or absent disclosure policies. But strong <a href="https://www.bmj.com/content/382/bmj-2023-076173.full">evidence</a> that industry payments play a key role in unethical pharmaceutical marketing provides additional impetus for tightening disclosure requirements. </p>
<p>One might expect that transparent reporting of industry payments would discourage doctors from accepting such largesse. This appears not to have happened in the US. Even with its system of mandatory and comprehensive reporting, the volume and impact of payments persist, possibly because most doctors <a href="https://doi.org/10.1016/S0002-9343(01)00660-X">don’t recognise</a> they’ve been influenced. </p>
<p>This suggests transparency requirements may be necessary but not sufficient to address undue industry influence on medical practice. </p>
<p>On a positive note, <a href="https://www.bmj.com/content/346/bmj.f264.short">restricting exposure to pharmaceutical marketing</a> during medical training, coupled with good role modelling by senior doctors, offers a promising means to prioritise evidence-based patient care over company profits.</p><img src="https://counter.theconversation.com/content/225457/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>David Menkes is a paid member of the Mental Health Advisory Committee for PHARMAC. </span></em></p>Growing evidence shows industry payments to doctors play a key role in unethical pharmaceutical marketing. New Zealand’s disclosure scheme fails to capture all companies and payment types.David Menkes, Associate Professor in Psychological Medicine, University of Auckland, Waipapa Taumata RauLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2146222023-10-12T12:31:00Z2023-10-12T12:31:00ZHorseshoe crab blood is vital for testing intravenous drugs, but new synthetic alternatives could mean pharma won’t bleed this unique species dry<figure><img src="https://images.theconversation.com/files/552874/original/file-20231010-19-onfdw4.jpg?ixlib=rb-1.1.0&rect=33%2C8%2C5579%2C3728&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Horseshoe crabs in spawning season at Reeds Beach, N.J., on June 13, 2023.</span> <span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/HorseshoeCrabHarvest/053d4f924f9c453f808a4d3724a87e73/photo">AP Photo/Matt Rourke</a></span></figcaption></figure><p>If you have ever gotten a vaccine or received an intravenous drug and did not come down with a potentially life-threatening fever, you can thank a horseshoe crab (<em>Limulus polyphemus</em>).</p>
<p>How can animals that are <a href="https://www.britannica.com/animal/horseshoe-crab">often called living fossils</a>, because they have barely changed over millions of years, be so important in modern medicine? Horseshoe crab blood is used to produce a substance called limulus amebocyte lysate, or LAL, which scientists use to test for <a href="https://www.britannica.com/science/endotoxin">toxic substances called endotoxins</a> in intravenous drugs. </p>
<p>These toxins, produced by bacteria, are ubiquitous in the environment and can’t be removed simply through sterilization. They can cause a reaction historically referred to as “<a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/pyrogens-still-danger">injection fever</a>.” A strong concentration can lead to shock and even death. </p>
<p>Identifying LAL as a highly sensitive detector of endotoxins was a 20th-century medical safety breakthrough. Now, however, critics are raising questions about environmental impacts and the process for reviewing and approving synthetic alternatives to horseshoe crab blood.</p>
<p>We study <a href="https://scholar.google.com/citations?user=Dd_T980AAAAJ&hl=en&authuser=1&oi=ao">science, technology</a> and <a href="https://www.linkedin.com/in/jolie-crunelle/%20student">public policy</a>, and recently published a <a href="https://osf.io/3tm9g/">white paper</a> examining social, political and economic issues associated with using horseshoe crabs to produce LAL. We see this issue as a test case for complicated problems that cut across multiple agencies and require attention to both nature and human health.</p>
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<iframe width="440" height="260" src="https://www.youtube.com/embed/CgRn3T7vcMw?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Protecting horseshoe crabs will require persuading the heavily regulated pharmaceutical industry to embrace change.</span></figcaption>
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<h2>An ocean solution</h2>
<p>Doctors began injecting patients with various solutions <a href="https://doi.org/10.1016/j.socscimed.2004.06.044">in the mid-1800s</a>, but it was not until the 1920s that biochemist <a href="https://lemelson.mit.edu/resources/florence-seibert">Florence Seibert</a> discovered that febrile reactions were due to contaminated water in these solutions. She created a method for detecting and removing the substances that caused this reaction, and it became the medical standard in the 1940s.</p>
<p>Known as the <a href="https://www.matresearch.com/pyrogen-testing/">rabbit pyrogen test</a>, it required scientists to inject intravenous drugs into rabbits, then monitor the animals. A feverish rabbit meant that a batch of drugs was contaminated.</p>
<p>The LAL method was discovered by accident. Working with horseshoe crabs at the <a href="https://www.mbl.edu/">Marine Biological Laboratory</a> at Woods Hole, Massachusetts, in the 1950s and ’60s, <a href="https://www.goldengooseaward.org/01awardees/horseshoe-crab-blood">pathobiologist Frederik Bang and medical researcher Jack Levin</a> noticed that the animals’ <a href="https://hub.jhu.edu/magazine/2021/summer/horseshoe-crabs-covid19-medical-uses/">blue blood</a> coagulated in a curious manner. Through a series of experiments, they isolated endotoxin as the coagulant and devised a method for extracting LAL from the blood. This compound would gel or clot nearly instantaneously in the presence of fever-inducing toxins.</p>
<p>Academic researchers, biomedical companies and the U.S. Food and Drug Administration refined LAL production and measured it against the rabbit test. By the 1990s, LAL was the <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/bacterial-endotoxinspyrogens">FDA-approved method</a> for testing medicines for endotoxin, largely replacing rabbits.</p>
<p>Producing LAL requires harvesting horseshoe crabs from oceans and beaches, <a href="https://www.theatlantic.com/technology/archive/2014/02/the-blood-harvest/284078/">draining up to 30% of their blood</a> in a laboratory and returning the live crabs to the ocean. There’s dispute about <a href="https://www.scientificamerican.com/article/medical-labs-may-be-killing-horseshoe-crabs/">how many crabs die in the process</a> – estimates range from a few percent to 30% or more – and about possible harmful effects on survivors. </p>
<p>Today there are five FDA-licensed <a href="https://asmfc.org/uploads/file/645bf065HSC_Biomedical_BMPs_2023.pdf">LAL producers</a> along the U.S. East Coast. The amount of LAL they produce, and its sales value, are proprietary. </p>
<h2>Bait versus biotech</h2>
<p>As biomedical LAL production ramped up in the 1990s, so did harvesting horseshoe crabs to use as bait for other species, particularly eel and whelk for foreign seafood markets. Over the past 25 years, hundreds of thousands – and in the early years, millions – of horseshoe crabs have been harvested each year for these purposes. Combined, the two fisheries kill <a href="https://asmfc.org/species/horseshoe-crab">over half a million</a> horseshoe crabs every year.</p>
<p>There’s no agreed total population estimate for <em>Limulus</em>, but the most recent <a href="https://asmfc.org/uploads/file/63d2ed62HSCAssessment_PeerReviewReport_May2019.pdf">federal assessment of horseshoe crab fisheries</a> found the population was neither strongly growing nor declining.</p>
<p>Conservationists are worried, and not just about the crabs. Millions of shorebirds <a href="https://atlanticflywayshorebirds.org/">migrate along the Atlantic coast</a>, and many stop in spring, when horseshoe crabs spawn on mid-Atlantic beaches, to feed on the crabs’ eggs. Particularly for <a href="https://www.allaboutbirds.org/guide/Red_Knot/overview">red knots</a> – a species that can migrate up to 9,000 miles between the tip of South America and the Canadian Arctic – gorging on horseshoe crab eggs provides a critical energy-rich boost on their grueling journey.</p>
<p>Red knots were <a href="https://www.federalregister.gov/documents/2014/12/11/2014-28338/endangered-and-threatened-wildlife-and-plants-threatened-species-status-for-the-rufa-red-knot">listed as threatened</a> under the Endangered Species Act in 2015, largely because horseshoe crab fishing threatened this key food source. As biomedical crab harvests came to equal or <a href="https://asmfc.org/species/horseshoe-crab">surpass bait harvests</a>, conservation groups began calling on the LAL industry to find new sources.</p>
<p><div data-react-class="InstagramEmbed" data-react-props="{"url":"https://www.instagram.com/p/Ct2Aji4xcPJ/?utm_source=ig_web_copy_link\u0026igshid=MzRlODBiNWFlZA==","accessToken":"127105130696839|b4b75090c9688d81dfd245afe6052f20"}"></div></p>
<h2>Biomedical alternatives</h2>
<p>Many important medicines are derived from living organisms. Penicillin, the first important antibiotic, was <a href="https://www.sciencemuseum.org.uk/objects-and-stories/how-was-penicillin-developed">originally produced from molds</a>. Other medicines currently in use come from sources including <a href="https://www.goodrx.com/well-being/diet-nutrition/medications-that-contain-animal-byproducts">cows, pigs, chickens and fish</a>. The ocean is a <a href="https://oceanexplorer.noaa.gov/facts/medicinesfromsea.html">promising source</a> for such products.</p>
<p>When possible, synthesizing these substances in laboratories – especially widely used medications like <a href="https://www.cityofhope.org/breakthroughs/art-riggs-tribute">insulin</a> – offers many benefits. It’s typically cheaper and more efficient, and it avoids putting species at risk, as well as addressing <a href="https://www.uspharmacist.com/article/animal-derived-medications-can-be-problematic-for-some-patients">concerns some patients have</a> about using animal-derived medical products.</p>
<p>In the 1990s, researchers at the National University of Singapore <a href="https://patents.google.com/patent/WO1999015676A1/en?inventor=Jeak+Ling+Ding">invented and patented</a> the first process for creating a synthetic, endotoxin-detecting compound using horseshoe crab DNA and <a href="https://www.genome.gov/genetics-glossary/Recombinant-DNA-Technology">recombinant DNA technology</a>. The result, dubbed recombinant Factor C (rFC), mimicked the first step in the three-part cascade reaction that occurs when LAL is exposed to endotoxin. </p>
<p>Later, several biomedical firms <a href="https://www.americanpharmaceuticalreview.com/Featured-Articles/569887-Historical-Milestones-and-Industry-Drivers-in-the-Development-of-Recombinant-Lysate-for-Bacterial-Endotoxin-Testing/">produced their own versions</a> of rFC and compounds called recombinant cascade reagents (rCRs), which reproduce the entire LAL reaction without using horseshoe crab blood. Yet, today, LAL remains the dominant technology for detecting endotoxins in medicine. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/552876/original/file-20231010-22-ilv12l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A vial partly filled with pale blue fluid" src="https://images.theconversation.com/files/552876/original/file-20231010-22-ilv12l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/552876/original/file-20231010-22-ilv12l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/552876/original/file-20231010-22-ilv12l.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/552876/original/file-20231010-22-ilv12l.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/552876/original/file-20231010-22-ilv12l.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/552876/original/file-20231010-22-ilv12l.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/552876/original/file-20231010-22-ilv12l.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">A sample of horseshoe crab blood.</span>
<span class="attribution"><a class="source" href="https://flic.kr/p/riAZsU">Florida Fish and Wildlife Commission</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
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<p>The main reason is that the <a href="https://www.usp.org/">U.S. Pharmacopeia</a>, a quasi-regulatory organization that sets safety standards for medical products, considers rFC and rCR as “alternative” methods for detecting endotoxins, so they require case-by-case validation for use – a potentially lengthy and expensive process. The FDA generally defers to the U.S. Pharmacopeia.</p>
<p>A few large pharmaceutical companies with deep pockets have committed to <a href="https://www.esg.lilly.com/environmental/biodiversity?redirect-referrer=https%3A%2F%2Fwww.google.com%2F#case-studies">switching from LAL to rFC</a>. But most drug producers are sticking with the tried-and-true method. </p>
<p>Conservation groups want the U.S. Pharmacopeia to <a href="https://www.audubon.org/magazine/summer-2018/inside-biomedical-revolution-save-horseshoe-crabs">fully certify rFC</a> for use in industry with no extra testing or validation. In their view, LAL producers are stalling rFC and rCR approval to protect their <a href="https://www.npr.org/2023/06/10/1180761446/coastal-biomedical-labs-are-bleeding-more-horseshoe-crabs-with-little-accountabi">market in endotoxin detection</a>. The U.S. Pharmacopeia and LAL producers counter that they are doing due diligence to <a href="https://hsc.criver.com/#lal-endo">protect public health</a>.</p>
<h2>Change in the offing</h2>
<p>Change may be coming. All major LAL producers now have their own recombinant products – a tacit acknowledgment that markets and regulations are moving toward <em>Limulus</em>-free ways to test for endotoxins. </p>
<p>Atlantic fisheries regulators are currently considering <a href="https://www.asmfc.org/home/2023-annual-meeting">new harvest limits for horseshoe crabs</a>, and the U.S. Pharmacopeia is <a href="https://www.uspnf.com/notices/86-bet-using-recombinant-tests-gen-annc-20230822">weighing guidance</a> on recombinant alternatives to LAL. Public comments will be solicited over the winter of 2024, followed by U.S. Pharmacopeia and FDA review. </p>
<p>Even if rFC and rCR don’t win immediate approval, we believe that collecting more complete data on horseshoe crab populations and requiring more transparency from the LAL industry on <a href="https://asmfc.org/uploads/file/645bf065HSC_Biomedical_BMPs_2023.pdf">how it handles the crabs</a> would represent progress. So would directing medical companies to use recombinant products for testing during the manufacturing process, while saving LAL solely for final product testing. </p>
<p>Making policy on complex scientific issues across diverse agencies is never easy. But in our view, incremental actions that protect both human health and the environment could be important steps forward.</p><img src="https://counter.theconversation.com/content/214622/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>This material is based upon work supported by the National Science Foundation under Award No. 2121146, as well as the Leverhulme Trust through a Leverhulme Trust Research Project Grant. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the National Science Foundation or the Leverhulme Trust.</span></em></p><p class="fine-print"><em><span>Jolie Crunelle receives funding from the Aberg Family Fellowship at Rochester Institute of Technology. </span></em></p>Horseshoe crabs play a unique role in medicine, but they’re also ecologically important in their home waters along the Atlantic coast. Can regulators balance the needs of humans and nature?Kristoffer Whitney, Associate Professor of Science, Technology and Society, Rochester Institute of TechnologyJolie Crunelle, Master's Degree Student in Science, Technology, and Public Policy, Rochester Institute of TechnologyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2154922023-10-11T21:39:24Z2023-10-11T21:39:24ZPoliticians come and go, but the clock is now ticking on long-promised pharmacare<figure><img src="https://images.theconversation.com/files/553352/original/file-20231011-17-yyenn6.jpg?ixlib=rb-1.1.0&rect=89%2C224%2C4949%2C2766&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Canada's long-promised yet undelivered pharmacare program may be entering the most crucial phase in its history.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><iframe style="width: 100%; height: 100px; border: none; position: relative; z-index: 1;" allowtransparency="" allow="clipboard-read; clipboard-write" src="https://narrations.ad-auris.com/widget/the-conversation-canada/politicians-come-and-go-but-the-clock-is-now-ticking-on-long-promised-pharmacare" width="100%" height="400"></iframe>
<p>The sword of Damocles hangs over the Trudeau government as it prepares a pharmacare bill that must be passed this year to uphold its <a href="https://www.pm.gc.ca/en/news/news-releases/2022/03/22/delivering-canadians-now">supply and confidence agreement</a> with the NDP. This month might be the most crucial time in the history of pharmacare, the long-promised yet undelivered program that would add necessary medicines to Canada’s national health insurance system.</p>
<p>Pharmacare is more than just a financial system. It is — <a href="https://www.longwoods.com/content/24637/healthcare-policy/a-better-prescription-advice-for-a-national-strategy-on-pharmaceutical-policy-in-canada">or should be</a> — a system of policies aimed at integrating medicines into Canadian Medicare to ensure access to a safe and secure supply of treatments at affordable prices. </p>
<p>Given the current challenges, pharmacare is once again in peril of failing to launch. A national procurement program for essential medicines, like the program used to acquire COVID-19 vaccines during the pandemic, could provide a feasible, evidence-based solution for Canadians.</p>
<h2>Rocky discussions</h2>
<p><a href="https://twitter.com/DonDavies/status/1707877877985993207">Public statements</a> from NDP health critic Don Davies signal that discussions on the bill have been rocky. </p>
<p>The NDP are trying to hold the government to the recommendations of Trudeau’s own <a href="https://www.canada.ca/en/health-canada/corporate/about-health-canada/public-engagement/external-advisory-bodies/implementation-national-pharmacare.html">Advisory Council on the Implementation of National Pharmacare</a>, chaired by former Ontario health minister, Eric Hoskins. That recommendation was a universal, public program for covering medicines on a national formulary (a list of drugs to be included), beginning with about 100 of the most commonly prescribed, “essential medicines.” That first stage is critical, whether financed by Ottawa alone or in conjunction with provinces.</p>
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<p>In contrast, the <a href="https://www.clhia.ca/web/CLHIA_LP4W_LND_Webstation.nsf/page/4BDB561E2BD420448525895F005B3327/$file/2023%20Consultation%20Finance%20Canada.pdf">private insurance</a> and <a href="https://innovativemedicines.ca/wp-content/uploads/2023/06/20230601-Addendum-to-Innovative-Medicines-Canada-Submission-on-National-Pharmacare_FINAL.pdf">pharmaceutical</a> industries have lobbied for an American-style, “fill-the-gaps” system that would rely on — possibly even legally mandate — work-related private insurance for prescription drugs. Québec implemented such a system in 1997 to the delight of industry stakeholders but at great <a href="https://doi.org/10.1503/cmaj.170726">cost to patients, businesses and even taxpayers</a>.</p>
<p><a href="https://www.healthcoalition.ca/ndp-rejects-liberals-draft-pharmacare-bill/">The NDP has signalled</a> that “fill-the-gaps” pharmacare does not fulfil the government’s obligations under the supply and confidence agreement. Unfortunately, however, Trudeau’s government appears weak in the face of industry lobbying.</p>
<h2>Delays and challenges</h2>
<p>In 2019, the federal government planned to <a href="https://www.canada.ca/en/health-canada/news/2019/08/government-of-canada-announces-changes-to-lower-drug-prices-and-lay-the-foundation-for-national-pharmacare.html">reduce drug prices as a “foundation” for national pharmacare</a>, but later <a href="https://doi.org/10.1016/S0140-6736(23)00956-X">delayed and then watered down and walked back patented drug pricing reforms</a>. </p>
<p>Those reforms would have prevented firms from price gouging on medicines to treat serious conditions, such as rheumatoid arthritis and cancer. Prominent officials involved in the reform process <a href="https://doi.org/10.1503/cmaj.1096044">resigned in protest</a> of what appeared to be meddling from the office of health minister Jean-Yves Duclos.</p>
<p>After a cabinet shuffle in July, the pharmacare file now lies heavily on the desk of <a href="https://www.cbc.ca/news/politics/mark-holland-health-minister-pharmacare-1.6938470">Health Minister Mark Holland</a>. In the coming days, perhaps weeks, the minister needs to find a path that stays true to the government’s own recommendations, its prior commitments to Canadians and its deal with the NDP. The plan must also be one that provincial governments will support.</p>
<p>At this point, it does not seem viable for the federal government to launch the complete vision of national pharmacare laid out in the <a href="https://www.canada.ca/en/health-canada/corporate/about-health-canada/public-engagement/external-advisory-bodies/implementation-national-pharmacare/final-report.html">Hoskins report</a>. That would be a $38.5 billion, comprehensive, program that would be administered by provinces but require $15 billion in new federal funding, plus $23 billion contributed by provinces. The latter is not new money but is a source of provincial anxiety and political tension to say the least.</p>
<h2>National procurement</h2>
<p>There is another way for the government to act in a principled and evidence-based manner that could not only get them out of this bind but also leave a positive legacy for generations to come. </p>
<p>The federal government could procure essential medicines nationally for distribution by provincial governments, <a href="https://www.tpsgc-pwgsc.gc.ca/trans/documentinfo-briefingmaterial/lcp-cow/2022-05-19/p2-eng.html">just as it has done for COVID-19 vaccines, tests and treatments</a> for the past three years.</p>
<p>More than 100 countries have developed <a href="https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2023.02">essential medicines lists</a> for national procurement and distribution. We have evidence that providing Canadians with coverage of approximately 125 essential medicines to treat a wide range of conditions will <a href="https://doi.org/10.1001/jamainternmed.2019.4472">improve health care for patients</a>, reduce financial burdens on families and <a href="https://doi.org/10.1001/jamahealthforum.2023.1127">lower costs elsewhere in the health-care system</a>.</p>
<p>National procurement will reduce the cost of these medicines through bulk purchasing. It can also reduce shortages of medicines on the list by including security of supply provisions into the national supply contracts. Countries that used these <a href="https://doi.org/10.1377/hlthaff.2012.1268">best practices in supply contracts</a> reduce the risks of drug shortages while still achieving prices that are as much as <a href="https://doi.org/10.1503/cmaj.180197">90 per cent lower than Canadians pay</a>.</p>
<p>Federal funding of essential medicines will, of course, cost the federal government, since it would foot the bill for all of those essential medicines instead of the provinces paying much of the costs. But the <a href="https://www.canada.ca/en/health-canada/corporate/about-health-canada/public-engagement/external-advisory-bodies/implementation-national-pharmacare/final-report.html">$7.6 billion price tag</a> is a bargain.</p>
<p>All told, a program of this kind could save provinces, employers and families $12 billion in reduced prescription drug costs. The $4 billion in direct savings for provinces alone is enough to entice even the most recalcitrant of provincial governments.</p>
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Read more:
<a href="https://theconversation.com/with-a-pharmacare-bill-on-the-horizon-big-pharmas-attack-on-single-payer-drug-coverage-for-canadians-needs-a-fact-check-213041">With a pharmacare bill on the horizon, Big Pharma’s attack on single-payer drug coverage for Canadians needs a fact check</a>
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<p>On the other hand, Trudeau’s government could do what industry lobbyists want them to do. Such a program will not save provinces, employers and families any money; it will cost them $5 billion more than they are already paying for medicines.</p>
<p>Another Trudeau faced a similar challenge in 1983 when provincial premiers, ministers of health, and ministers of finance joined health care lobbyists in opposition to a <a href="https://www.historymuseum.ca/cmc/exhibitions/hist/medicare/medic-7h01e.html">contentious bill</a>. </p>
<p>Former Prime Minister Pierre Trudeau and Health Minister Monique Bégin stood strong and, in the dying months of their government, got the cornerstone <a href="https://laws-lois.justice.gc.ca/eng/acts/c-6/page-1.html">Canada Health Act</a> passed.</p>
<p>The sword now dangles over Prime Minister Justin Trudeau and Health Minister Holland who will either buckle under the pressure from industry lobbying or rise to a long-promised signature policy that could shape this government’s legacy.</p><img src="https://counter.theconversation.com/content/215492/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nav Persaud receives funding from the CIHR and other government sources. </span></em></p><p class="fine-print"><em><span>Steven G. Morgan has received funding from Health Canada for research in support of the Advisory Council on the Implementation of National Pharmacare (2018-2019).</span></em></p>A national procurement program for essential medicines could provide a principled, evidence-based solution to the current challenges facing a national pharmacare program in Canada.Nav Persaud, Canada Research Chair in Health Justice, University of TorontoSteven G. Morgan, Professor, School of Population and Public Health, University of British ColumbiaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2130412023-09-11T23:27:09Z2023-09-11T23:27:09ZWith a pharmacare bill on the horizon, Big Pharma’s attack on single-payer drug coverage for Canadians needs a fact check<figure><img src="https://images.theconversation.com/files/547294/original/file-20230908-23-s1i9fc.jpg?ixlib=rb-1.1.0&rect=201%2C23%2C4974%2C3243&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Under a pharmacare plan, a single bargaining agent negotiates for lower prices from drug companies.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><iframe style="width: 100%; height: 100px; border: none; position: relative; z-index: 1;" allowtransparency="" allow="clipboard-read; clipboard-write" src="https://narrations.ad-auris.com/widget/the-conversation-canada/with-a-pharmacare-bill-on-the-horizon-big-pharmas-attack-on-single-payer-drug-coverage-for-canadians-needs-a-fact-check" width="100%" height="400"></iframe>
<p>Health Minister Mark Holland <a href="https://www.cbc.ca/news/politics/mark-holland-health-minister-pharmacare-1.6938470">announced in August</a> that the federal government intends to introduce pharmacare legislation in the fall. Now the battle lines are being drawn.</p>
<p>One of the many virtues of pharmacare — a universal drug coverage plan — is that there will be a single bargaining agent looking for lower prices from the drug companies. Australia has a single buyer and has brand-name prices that are on average <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2021.html">29 per cent lower than Canada’s</a>. That difference on Canadian annual sales of $17.4 billion translates into savings of about $5 billion.</p>
<p>Pharmaceutical and insurance industries that stand to lose profit through lower drug prices are not happy about pharmacare. They are speaking out and mobilizing their allies. </p>
<h2>‘Fill in the gaps’</h2>
<p>Innovative Medicines Canada, the lobby group for Big Pharma, is pushing for a “<a href="https://innovativemedicines.ca/newsroom/all-news/imc-calls-on-canadas-premiers-to-improve-patient-access-to-medicines/">fill in the gaps</a>” model. That means providing coverage for people who don’t have drug insurance, but leaving the current system otherwise untouched.</p>
<p>Québec already has “filled in the gaps.” However, it <a href="https://doi.org/10.1503/cmaj.170726">hasn’t achieved the solutions shown in countries with pharmacare</a>. Québec spends more per capita on drugs than other provinces. A greater percentage of people in Québec (8.7 per cent) report spending more than $1,000 on prescription drugs in one year, compared to comparable countries with pharmacare (three per cent) or even the rest of Canada (4.8 per cent).</p>
<p>In Québec, nine per cent of its residents report that they go without their medications because they cannot afford them. While this is an improvement on the rest of the country, with 11 per cent of Canadians in other provinces skipping medications due to costs, it is still significantly higher than the numbers in most comparable countries with pharmacare (six per cent or less).</p>
<h2>The 97 per cent myth</h2>
<p>GreenShield, a not-for-profit health benefits provider and a member of the Canadian Life and Health Insurance Association (CLHIA), appears to share the insurance industry’s stand against pharmacare. In July it <a href="https://www.theglobeandmail.com/business/article-greenshield-cares-essential-medicines-low-income/">announced a pilot program</a> that will offer up to $1,000 in drug coverage to low-income Canadians who do not have public or private prescription drug insurance.</p>
<p>In making the announcement, GreenShield’s chief executive Zahid Salman repeated the myth that 97 per cent of Canadians already have drug coverage. That 97 per cent number is theoretical. Having some form of coverage does not necessarily make drugs affordable. For example, if you live in <a href="https://www.gov.mb.ca/health/pharmacare/estimator.html">Manitoba</a> and your family income is $47,500, you’ll first have to pay $2,760 out of pocket. Anything less and there’s no public coverage. </p>
<p>According to a recent report from <a href="https://www150.statcan.gc.ca/n1/pub/75-006-x/2022001/article/00011-eng.htm">Statistics Canada</a>, 33 per cent of seniors in Manitoba don’t have drug coverage. (That figure might be lower if some seniors who are eligible for provincial insurance didn’t register or were unaware that they were covered.)</p>
<h2>Not everyone has workplace benefits</h2>
<p>CLHIA came out swinging after the federal NDP tabled a <a href="https://www.ctvnews.ca/politics/ndp-attempts-to-prod-liberals-into-action-on-pharmacare-by-tabling-its-own-bill-1.6439036">pharmacare bill</a> in June. The NDP’s bill called for a federal, universal, public and single-payer drug plan. In other words, a plan similar to what Canadians already enjoy for doctor and hospital services. </p>
<p>Denis Ricard, chair of the CLHIA’s board of directors, has claimed that “<a href="https://breachmedia.ca/greenshield-insurance-industry-fights-liberal-ndp-pharmacare/">a fully one-payer national pharmacare is going to be a disaster for this country</a>.”</p>
<p>The <a href="https://betterhealthbenefits.ca/">Better Health Benefits, Together</a> campaign being run by the CLHIA warns that Canadians “can’t afford to lose their workplace benefits because of politics…Done the wrong way, Canadians will lose access to medicines they use today.” </p>
<p>The campaign fails to mention that workplace benefits do not cover everyone, and exclude those experiencing unemployment, which affects some populations more than others. For example, <a href="https://www150.statcan.gc.ca/n1/pub/75-006-x/2022001/article/00011-eng.htm">racialized Canadians have a higher unemployment rate</a> than the rest of the population and therefore are less likely to have work-based drug coverage. </p>
<p>Nor does the campaign mention that, according to <a href="https://www150.statcan.gc.ca/n1/pub/75-006-x/2022001/article/00011-eng.htm">Statistics Canada</a>, “the majority of insurance coverage changes due to the pandemic were negative,” with immigrants faring worse than non-immigrants.</p>
<h2>High deductibles</h2>
<p>Joining the battle against pharmacare is <a href="https://www.thestar.com/opinion/contributors/canada-has-in-fact-achieved-universal-drug-insurancecoverage/%2520article_65bc7a1e-8fb2-56d5-abb8-1b5890909597.html">Brett Skinner</a>, the CEO of the free market Canadian Health Policy Institute. Skinner’s message is that a national government-run drug insurance program is not necessary and will be bad for patients and costly for taxpayers. </p>
<p>He argues that private plans cover more drugs, and cover new drugs more quickly than public plans, and that if Canadians are faced with high deductibles there are provincial programs to deal with them.</p>
<p>He neglects to mention that <a href="https://doi.org/10.1177%2F20542704231166620">only about 10 to 15 per cent of new drugs provide any substantial new benefits</a> compared to existing drugs. He fails to note that a third of the difference in the time between public and private coverage is because <a href="https://doi.org/10.9778/cmajo.20220063">drug companies don’t take advantage of the opportunity to apply for coverage as quickly as they could</a>. </p>
<p>Skinner also ignores the fact that <a href="https://doi.org/10.1503%2Fjpn.180051">people living in Manitoba</a> with an annual income of just over $55,000 who are taking three drugs a day are faced with deductibles of up to $350 every three months. British Columbia residents aren’t far behind at $300 every three months.</p>
<p>Big Pharma, the insurance industry and free market zealots are all motivated by money and ideology. In a battle over people’s health, greed shouldn’t be the winner.</p><img src="https://counter.theconversation.com/content/213041/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Between 2019-2023, Joel Lexchin received payments for writing briefs on the role of promotion in generating prescriptions for two legal firms. He is a member of the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. Between 2017 and 2023 he was a coinvestigator on four different projects funded by the Canadian Institutes of Health Research.</span></em></p>Pharmaceutical and insurance industries that could lose profit through lower drug prices are not happy that a pharmacare bill is planned for fall. They are speaking out and mobilizing their allies.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, CanadaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2074632023-06-26T19:51:26Z2023-06-26T19:51:26ZCanada’s misguided changes to drug regulation could fast-track unproven medications and divert funds from other health needs<p>The Canadian government is proposing a new “<a href="https://canadagazette.gc.ca/rp-pr/p1/2022/2022-12-17/html/reg1-eng.html">Agile Licensing</a>” framework to expedite pre-market regulation of pharmaceuticals. While Health Minister Jean-Yves Duclos claims this is part of the government’s strategy to offer Canadians “<a href="https://www.ourcommons.ca/DocumentViewer/en/44-1/HESA/meeting-64/evidence">access to quality and affordable medicines</a>,” the policy is likely to cause more harm than good.</p>
<p>Adoption of Agile Licensing would allow companies to market drugs up to six months earlier than under the current system. Fewer pre-market clinical trials would be required as long as firms continue studying their drugs’ effectiveness after they are already in use.</p>
<p>The government suggests this new approach will significantly improve Canadians’ quality of life, estimating the value of this improvement at <a href="https://canadagazette.gc.ca/rp-pr/p1/2022/2022-12-17/html/reg1-eng.html">$302 million over ten years</a>. However, the assumptions behind this estimate are flawed.</p>
<h2>Flawed assumptions</h2>
<p>By design, Canada will have less information about the risks of new medicines if those drugs enter the market with less pre-market clinical data. This will become a problem if a company fails to conduct promised post-market studies or if Health Canada does not remove unsafe or ineffective medicines from the market. </p>
<p>Unfortunately, <a href="https://doi.org/10.1136/bmj.n1898">the experience in the United States</a> shows that many fast-tracked drugs are not adequately studied after they are approved for sale and few are removed from the market, even if evidence shows they do not perform as suggested by their “promising” but incomplete pre-market trials.</p>
<p>Fast-tracking market approval for new, less-studied medicines is not only potentially wasteful in the first instance; it will inevitably divert money away from other uses in the health-care system to pay for costly but unproven drugs.</p>
<p>New medicines are (<a href="https://doi.org/10.1136%2Fbmj.38582.703866.AE">and have long been</a>) the primary driver of increasing spending on prescription drugs, for both private and public drug plans. In terms of budgets, new drugs do not simply replace older ones; <a href="https://www.canada.ca/en/patented-medicine-prices-review/news/2023/01/increased-use-of-higher-cost-medicines-continues-to-put-pressure-on-canadian-public-drug-plans.html">they increase the overall drug budget</a>, which necessarily means foregone opportunities to use those funds in other sectors of health care, such as improving access to joint replacements, nursing homes or mental health care.</p>
<p>There is a major flaw in Health Canada’s cost-benefit analysis of Agile Licensing: it overlooks the fact that accelerated access to — and therefore spending on — “promising” new medicines means less money for other forms of health care that Canadians need. </p>
<h2>Affordability</h2>
<p>Despite the Minister of Health’s assertions, the proposed framework contains no mechanism for making fast-tracked medicines “affordable.” This is extremely worrisome given the drugs that will be fast-tracked by this policy are patented, specialized medicines likely to be priced at levels that are unaffordable and <a href="https://doi.org/10.1136/bmj.l4627">arguably indefensible</a>.</p>
<p>Patents are government-granted time-limited monopolies that can stimulate innovation. However, they can also enable manufacturers of specialized medicines to charge exorbitant prices due to the life-or-death situations faced by patients who need such treatments. Pharmaceutical companies are using this market power to charge extraordinarily high prices with increasing frequency.</p>
<p>Before 2006, only four drugs approved in Canada had annual prices above $50,000 per patient — which is clearly a lot of money. Today, however, 67 medicines carry such a price tag, costing Canadians over <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2021.html">$3 billion per year</a> in total. Seven drugs now available in Canada are priced at an astonishing <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/npduis/analytical-studies/chartbook/expensive-drugs-rare-diseases-2011-2020.html">$1 million per patient</a>.</p>
<p>Higher drug prices do not guarantee more value or improvements to health and well-being. <a href="https://doi.org/10.1007/s40273-021-01087-6">Studies show</a> it typically costs <a href="http://www.pmprb-cepmb.gc.ca/CMFiles/Consultations/new_guidelines/Canada_report_2018-03-14_Final.pdf">around $30,000</a> to produce a measurable improvement in the health of one person, for one year in health-care systems like ours. However, new patented medicines often require hundreds of thousands of dollars for the same benefit.</p>
<h2>The harms of high drug prices</h2>
<p>This discrepancy between reasonable prices for generating health benefits and the prices charged for many new patented medicines indicates a failing system. It directly harms Canadians by preventing access to therapies due to prohibitive pricing, and it indirectly harms them by diverting funds from more effective investments that would yield greater health benefits per dollar spent.</p>
<p>Before fast-tracking drug approvals so that manufacturers can increase sales, policymakers should develop and enforce measures to ensure the prices charged will fall within reasonable limits. Unfortunately, the Canadian government recently <a href="https://doi.org/10.1016/S0140-6736(23)00956-X">backed down</a> from reforms that would have done just that.</p>
<p>Without a policy to ensure reasonable pricing of fast-tracked medicines, the government’s proposed Agile Licensing regulations will only hasten access to unproven therapies while drawing resources away from other forms of health care that Canadians need and that offer better value for money spent.</p><img src="https://counter.theconversation.com/content/207463/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Steven G. Morgan has received research funding from the Canadian Institutes of Health Research (CIHR), Health Canada, and other public organizations.</span></em></p><p class="fine-print"><em><span>Aidan Hollis receives funding from Canadian Institutes of Health Research (CIHR) and Hong Kong RGC Senior Research Fellowship Scheme. He is President of Incentives for Global Health. </span></em></p><p class="fine-print"><em><span>Christopher McCabe was previously CEO of The Institute of Health Economics, Alberta, which received research funding from a number of pharmaceutical companies during his tenure, including Astra Zeneca, Boerhinger Ingleheim, GSK, Novartis, Roche and Takeda.</span></em></p><p class="fine-print"><em><span>Matthew Herder receives funding from the Canadian Institutes of Health Research (CIHR), the Public Health Agency of Canada, and the not-for-profit foundation Arnold Ventures. He was previously a member of the Patented Medicine Prices Review Board (PMPRB), and received honoraria for his public service. </span></em></p><p class="fine-print"><em><span>Mike Paulden receives funding from the Canadian Institutes of Health Research (CIHR). He previously chaired a technical working group at the Patented Medicine Prices Review Board (PMPRB), and was a founding member of the Health Economics Advisory Council at the Canadian Agency for Drugs and Technologies in Health (CADTH).</span></em></p>The federal government’s proposed Agile Licensing drug approval regulations mean Canada will have less information about the risks of new medicines, and higher costs.Steven G. Morgan, Professor, School of Population and Public Health, University of British ColumbiaAidan Hollis, Professor of Economics, University of CalgaryChristopher McCabe, Professor of Health Economics, Queen's University BelfastMatthew Herder, Director of the Health Law Institute at the Schulich School of Law, Dalhousie UniversityMike Paulden, Associate professor, School of Public Health, University of AlbertaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1946962023-06-09T12:29:31Z2023-06-09T12:29:31Z‘From Magic Mushrooms to Big Pharma’ – a college course explores nature’s medicine cabinet and different ways of healing<figure><img src="https://images.theconversation.com/files/531019/original/file-20230608-20480-dlan6s.jpg?ixlib=rb-1.1.0&rect=428%2C512%2C4455%2C2984&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">People for millennia have used what grows around them as medicine.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/dangerous-mushroom-royalty-free-image/463172611">LorenzoT81/iStock via Getty Images Plus</a></span></figcaption></figure><figure class="align-right ">
<img alt="Text saying: Uncommon Courses, from The Conversation" src="https://images.theconversation.com/files/499014/original/file-20221205-17-kcwec8.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/499014/original/file-20221205-17-kcwec8.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=375&fit=crop&dpr=1 600w, https://images.theconversation.com/files/499014/original/file-20221205-17-kcwec8.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=375&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/499014/original/file-20221205-17-kcwec8.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=375&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/499014/original/file-20221205-17-kcwec8.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=471&fit=crop&dpr=1 754w, https://images.theconversation.com/files/499014/original/file-20221205-17-kcwec8.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=471&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/499014/original/file-20221205-17-kcwec8.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=471&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<p><em><a href="https://theconversation.com/topics/uncommon-courses-130908">Uncommon Courses</a> is an occasional series from The Conversation U.S. highlighting unconventional approaches to teaching.</em> </p>
<h2>Title of course:</h2>
<p>“From Magic Mushrooms to Big Pharma”</p>
<h2>What prompted the idea for the course?</h2>
<p>I’m from the foothills of the Appalachians in southern Ohio, where my Grandma Mildred would go out into the woods, which she called her medicine cabinet, to find herbs to use as medicine. <a href="https://scholar.google.com/citations?user=DhbiqSMAAAAJ&hl=en&oi=ao">I grew up to be an anthropologist</a>, interested in how people around the world heal themselves. In the 1990s, I did my dissertation research in Ecuador and learned how Indigenous people in the Choco region used <a href="https://doi.org/10.1007/s00213-019-05446-2">ayahuasca and other medicines from the forest</a> to assist in the grieving process.</p>
<p>With the <a href="https://mjbizdaily.com/map-of-us-marijuana-legalization-by-state/">legalization of cannabis in many states</a> and <a href="https://doi.org/10.3390/jof8080870">increased research</a> on <a href="https://doi.org/10.1007/s13311-017-0542-y">how “nontraditional” drugs can assist</a> people with post-traumatic stress disorder, depression and <a href="https://doi.org/10.2174/15733998113099990003">addiction issues</a>, it seemed like an opportune time to create this course. It’s part of a new interdisciplinary minor at Western Illinois University called “<a href="http://www.wiu.edu/academics/cannabis/culture/">Cannabis & Culture</a>” that offers students a foundation for understanding the social and cultural context, history and politics of nature-based medicine use in the United States and around the globe.</p>
<h2>What does the course explore?</h2>
<p>The course looks at how different peoples and cultures use nature-based medicines to heal themselves. First we establish that there are <a href="https://doi.org/10.1038/sj.embor.7400693">many ways of knowing the world around us</a>, just as there are many ways to heal ourselves. Some of us rely on Western medicine, others pray, yet others turn to Indigenous or traditional ways of healing that are rooted in nature.</p>
<p>We talk about the ways Western medicine now seeks to validate substances that have been used for healing for centuries, like research into how <a href="https://doi.org/10.3390/molecules27123877">ginger and turmeric can alleviate inflammation</a>, or the ways cannabis can <a href="https://doi.org/10.1016/j.yebeh.2016.09.040">reduce or even eliminate some epileptic seizures</a>.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/530983/original/file-20230608-27-tlrr54.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="closeup of five dots of blood on the shoulder of a man without a shirt" src="https://images.theconversation.com/files/530983/original/file-20230608-27-tlrr54.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/530983/original/file-20230608-27-tlrr54.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/530983/original/file-20230608-27-tlrr54.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/530983/original/file-20230608-27-tlrr54.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/530983/original/file-20230608-27-tlrr54.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/530983/original/file-20230608-27-tlrr54.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/530983/original/file-20230608-27-tlrr54.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Kambô frog medicine is a shamanic medicinal ritual that originates among Amazonian tribes who use the poisonous excretion from the <em>Phyllomedusa bicolor</em> tree frog to cure illness.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/kambo-frog-poison-medicine-for-body-detox-royalty-free-image/1065635962">GummyBone/iStock via Getty Images Plus</a></span>
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<p>We also examine how the <a href="https://doi.org/10.1111/j.1471-8847.2006.00168.x">pharmaceutical industry has</a> <a href="https://www.northatlanticbooks.com/shop/biopiracy/">exploited Indigenous peoples’ ethnobotanical knowledge</a> <a href="https://doi.org/10.1155/2021/8898842">and landscapes for monetary gain</a>.</p>
<p>Using the Amazonian giant leaf frog, or kambô (<em><a href="https://amphibiaweb.org/cgi/amphib_query?where-genus=Phyllomedusa&where-species=bicolor&account=amphibiaweb">Phyllomedusa bicolor</a></em>), as a case study, students learn that at least 15 Indigenous groups have long histories of using the frog’s secretion for its analgesic, antibiotic and wound-healing properties. <a href="https://news.mongabay.com/2022/05/amazon-frog-highlights-appropriation-of-indigenous-knowledge-for-commercial-gain/">Eleven patents related to <em>P. bicolor</em> have been granted</a> – all of them in rich countries. Indigenous people have not been compensated for their knowledge.</p>
<h2>Why is this course relevant now?</h2>
<p>The current generation of young people are <a href="https://magazine.medlineplus.gov/article/teens-are-talking-about-mental-health">open about mental health issues</a>, and many people are looking for new ways to deal with anxiety, grief, PTSD and depression. My students can discuss their health concerns and learn about alternatives to what they may be accustomed to.</p>
<p>At this politically and racially polarized moment in the U.S., the course also provides the opportunity to discuss how <a href="https://doi.org/10.1089/can.2019.0063">racism, misogyny and discrimination against people of color</a> have influenced scientific research.</p>
<h2>What’s a critical lesson from the course?</h2>
<p>Over the course of the semester, students begin to recognize that there is no one right way of healing. More importantly, there is no one right way of being human. It is my hope that students leave seeing that everything is connected, integrally linked to humanity’s relationship to nature. </p>
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<a href="https://images.theconversation.com/files/531020/original/file-20230608-17666-2vej3s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="rows of marijuana crop inside a greenhouse with two agricultural workers" src="https://images.theconversation.com/files/531020/original/file-20230608-17666-2vej3s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/531020/original/file-20230608-17666-2vej3s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/531020/original/file-20230608-17666-2vej3s.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/531020/original/file-20230608-17666-2vej3s.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/531020/original/file-20230608-17666-2vej3s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/531020/original/file-20230608-17666-2vej3s.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/531020/original/file-20230608-17666-2vej3s.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">In some parts of the U.S., cannabis is now just another agricultural crop.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/large-amounts-and-endless-rows-of-marijuana-crop-stand-news-photo/1254375856">Mark Abramson/The Washington Post via Getty Images</a></span>
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<h2>What materials does the course feature?</h2>
<ul>
<li><p>Scientific materials provided by the <a href="https://maps.org/">Multidisciplinary Association for Psychedelic Studies</a>, a nonprofit that provides some of the only scientific research on psychedelics in the U.S. and promotes awareness of these drugs</p></li>
<li><p>“<a href="https://www.penguinrandomhouse.com/books/529343/how-to-change-your-mind-by-michael-pollan/">How to Change your Mind</a>,” by Michael Pollan and the accompanying <a href="https://www.imdb.com/title/tt21062540/">Netflix series</a> </p></li>
<li><p>Work of ethnobotanist Mark Plotkin, including his Ted Talk “<a href="https://www.ted.com/talks/mark_plotkin_what_the_people_of_the_amazon_know_that_you_don_t?language=en">What the people of the Amazon know that you don’t</a>”</p></li>
</ul>
<h2>What will the course prepare students to do?</h2>
<p>Studying how different cultures approach problems that plague all humans, like being sick and healing our ill, demonstrates to students that there are many ways the world over to solve problems. This course views different approaches not as a problem to be overcome but as a resource that can yield new ways of thinking and new opportunities – a definite advantage in the professional world. I hope students also learn to become advocates for their own health and well-being.</p><img src="https://counter.theconversation.com/content/194696/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Heather McIlvaine-Newsad does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>An anthropology course explores how peoples and cultures around the world use nature-based medicines to heal.Heather McIlvaine-Newsad, Professor of Anthropology, Western Illinois UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/2025272023-03-29T09:06:46Z2023-03-29T09:06:46ZIndustries can harm health in many ways: here are 3 that aren’t so obvious<figure><img src="https://images.theconversation.com/files/517863/original/file-20230328-18-pfw5ql.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Research confirms the adverse effects of social media on mental health.</span> <span class="attribution"><span class="source">Shutterstock </span></span></figcaption></figure><p>A recent ground-breaking <a href="https://www.thelancet.com/series/commercial-determinants-health">series of reports</a> in the science journal The Lancet unpacks what commercial determinants of health are, and how they affect public health. It uses a new, broader definition of the determinants: </p>
<blockquote>
<p>the systems, practices and pathways through which commercial actors drive health and equity. </p>
</blockquote>
<p>Some commercial entities contribute positively to health and society. However, <a href="https://www.bmj.com/company/newsroom/new-evidence-links-ultra-processed-foods-with-a-range-of-health-risks/">research</a> shows that some commercial products and practices are directly linked to avoidable ill health, planetary damage, and social and health inequity. Large transnational corporations are especially to blame.</p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/profit-versus-health-4-ways-big-global-industries-make-people-sick-202368">Profit versus health: 4 ways big global industries make people sick</a>
</strong>
</em>
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<p>The Lancet series examines not just directly damaging products (such as alcohol or ultra-processed foods) but the commercial practices that influence human health, inequities in health and planetary health. The series highlights the need to better understand the diversity within the commercial world, and the variety of ways its normal operations harm humanity and the planet. </p>
<h2>3 ‘hidden’ industries that can harm your health</h2>
<p>Some seemingly benign – or even beneficial – industries actually have major and avoidable impacts on health. They contribute negatively to health in subtle or indirect ways.</p>
<p>The <a href="https://journals.sagepub.com/doi/10.1177/01410768211053006">pharmaceutical industry</a> is one. Its abuse of <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32581-2/fulltext">intellectual property</a> to increase prices and limit access to essential drugs is a common trend. The pre-selling of COVID-19 vaccines to wealthy countries is a recent, massive-scale example. The industry’s longstanding resistance to lowering the price of antiretroviral drugs for HIV meant that untold thousands, mostly in developing countries, died because they lacked access to treatment. </p>
<p>Social media is another industry of particular concern especially given the increase in its consumption in recent years. A plethora of research confirms the <a href="https://www.medicalnewstoday.com/articles/social-media-and-mental-health#statistics">adverse effects of social media on mental health</a>, especially an increase in cases of depression and anxiety.</p>
<p>On top of this, other industries often use social media to promote harmful products and for “<a href="https://www.esgthereport.com/what-is-social-washing/">social washing</a>”, a strategy employed by companies to promote themselves as more socially responsible than they actually are, purely for brand promotion. We have also seen an increase in “surveillance capitalism” whereby private information is gathered through social media use. The information is then used by, for example, junk food companies through platforms such as <a href="https://economictimes.indiatimes.com/industry/cons-products/food/junk-food-brands-using-facebook-to-target-young-people/articleshow/44938881.cms">Facebook for the targeted marketing of unhealthy commodities</a>.</p>
<p>Extractive companies have also been linked to various health and planetary harms. Air and water pollution, environmental degradation, fatalities, silicosis, and noise-induced hearing loss are just a few examples of these harms. A <a href="https://www.hrw.org/news/2018/08/27/south-africa-how-mining-damages-communities-and-environment#:%7E:text=The%20South%20African%20Human%20Rights,%5Band%5D%20the%20environment.%22">report by the South African Human Rights Commission</a> has severely criticised the mining industry and held that this sector “is riddled with challenges related to land, housing, water and the environment”. </p>
<p>In the South African context, the harms created by the mining industry are particularly concerning given the knock-on, damaging socio-economic effects – for example as a result of the loss of breadwinners – on families and, often, vulnerable communities. </p>
<h2>Harmful business practices</h2>
<p>Not only can harm to global health come from a range of industries, it can also come indirectly from business practices. Three harmful practices are:</p>
<ul>
<li><p>Exploiting weak regulation in low- and middle-income countries. One example is the export of harmful <a href="https://news.bloomberglaw.com/environment-and-energy/developing-world-still-struggling-with-obsolete-pesticides">pesticides</a> to <a href="https://www.dailymaverick.co.za/article/2021-01-26-poison-on-a-plate-outdated-agrichemical-legislation-means-your-avocado-topped-pizza-could-be-hazardous-to-your-health/#:%7E:text=Paraquat%20%E2%80%94%20banned%20in%20the%20EU%2C%20available%20in%20SA&text=wearing%20protective%20equipment.-,In%20South%20Africa%2C%20the%20chemical%20is%20still%20widely%20used%2C%20not,residential%20estates%20and%20public%20places.">developing countries</a>. </p></li>
<li><p>Influencing policy agendas and actions through what appear to be <a href="https://www.theguardian.com/news/2018/may/24/the-trouble-with-charitable-billionaires-philanthrocapitalism">philanthropic activities</a>, but which benefit business rather than health. </p></li>
<li><p><a href="https://www.cnbc.com/2022/05/06/starbucks-accused-of-more-than-200-labor-violations-in-nlrb-complaint.html">Unfair labour</a> and <a href="https://www.theguardian.com/business/2022/dec/20/nike-lawsuit-records-sexual-abuse-toxic-workplace-claim">employment practices</a>.</p></li>
</ul>
<h2>Next steps</h2>
<p>Commercial determinants of health are clearly influenced by a much wider range of actors and practices than the more obvious product-related harms of the “big four” (tobacco, alcohol, ultra-processed foods and fossil fuels). No business entity is purely “good” or “bad”, but we have seen an increasing trend where companies use “beneficial” practices, such as sponsorship, donations and pledges to environmental causes, to mask harmful practices and influence politicians. </p>
<p>Without a common understanding that these industries are harming our health, no action can be taken against them. Holding industry accountable and stricter government regulation are the minimum actions needed. </p>
<p>The Lancet series authors are calling for a global move towards health-promoting models of commerce. This is a move away from emphasising profits and economic growth, and instead focusing on societal and planetary health and well-being. </p>
<p><em>This article is part of a media partnership between The Conversation Africa and PRICELESS SA, a research-to-policy unit based in the School of Public Health at the University of the Witwatersrand. Researchers from the SAMRC/Wits Centre for Health Policy and Decision Science also contributed to the Lancet series on the commercial determinants of health.</em></p><img src="https://counter.theconversation.com/content/202527/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Sameera Mahomedy does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Some commercial products and practices are directly linked to avoidable ill health, planetary damage, and social and health inequity. Large transnational corporations are especially to blame.Sameera Mahomedy, Researcher in Law and Policy, SAMRC/Centre for Health Economics and Decision Science - PRICELESS SA, University of the WitwatersrandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1973352023-01-09T19:57:15Z2023-01-09T19:57:15ZHow the pharmaceutical industry uses disinformation to undermine drug price reform<figure><img src="https://images.theconversation.com/files/503452/original/file-20230106-9978-995yzp.jpg?ixlib=rb-1.1.0&rect=0%2C94%2C5742%2C3721&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The pharma industry warned that if proposed new prescription price guidelines go ahead, drug launches would be delayed and 'Canadian patients will be deprived of potentially life-saving new medicines.'
</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>Canada’s drug prices are the <a href="https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2020.html">fourth highest in the developed world</a>. Despite this, Innovative Medicines Canada (IMC), the lobby group for Big Pharma, <a href="https://innovativemedicines.ca/newsroom/all-news/implementation-patented-medicine-prices-review-boards-proposed-guidelines-will-harm-canadian-patients/">put out a call</a> in November 2022 for the Canadian government to suspend consultations on guidelines aimed at lowering prescription drug prices. </p>
<p><a href="https://www.canada.ca/en/patented-medicine-prices-review/services/consultations/2022-proposed-updates-guidelines.html">The proposed guidelines</a> were expected to come into effect on Jan. 1, but were postponed in late December. </p>
<p>IMC warned that if the new guidelines went ahead, drug launches would be delayed and “Canadian patients will be deprived of potentially life-saving new medicines.”</p>
<p>Just a few days later, IMC took out a <a href="https://www.theglobeandmail.com/business/adv/article-shortening-the-regulatory-timeline-will-benefit-patients-and-the/">full-page ad in the <em>Globe and Mail</em></a> claiming that “Canadians wait twice as long for new medicines.” </p>
<p>The first statement is false and the second is a half-truth. Both are typical of an industry that <a href="https://www.citizen.org/article/twenty-seven-years-of-pharmaceutical-industry-criminal-and-civil-penalties-1991-through-2017/">paid US$38.6 billion in fines</a> in civil and criminal cases in the United States between 1991 and 2017.</p>
<h2>Falsehoods and half-truths</h2>
<p>IMC has been <a href="https://archive.innovativemedicines.ca/pmprb-still-time-regulations/">claiming since the end of 2020</a> that “new drugs are not being launched in Canada” because our drug prices might be lowered. However, between 2011 and 2020, there was <a href="https://doi.org/10.1016/j.healthpol.2022.08.006">no change in the timing</a> between when drugs were approved by the United States Food and Drug Administration (FDA) and then by Health Canada. </p>
<p>Drug companies did not wait longer to introduce new drugs here compared to the U.S. There was a <a href="https://doi.org/10.1016/j.healthpol.2022.08.006">decline in the per cent of drugs first approved by the FDA and then by Health Canada</a>, but the same thing happened in Australia where drug prices were not being lowered.</p>
<p>What about the claim that Canadians are losing out on new potentially life-saving drugs? </p>
<p>Only 10-15 per cent of new drugs are actually <a href="https://doi.org/10.1136/bmjopen-2018-023605">major therapeutic breakthroughs</a>. The industry claims the other 85-90 per cent <a href="https://ethics.harvard.edu/blog/new-prescription-drugs-major-health-risk-few-offsetting-advantages">give patients more choice</a>. But companies don’t test their new drugs on patients who can’t tolerate or don’t get better on older ones. So, nobody really knows if those choices mean anything positive for patients. </p>
<h2>Wait times</h2>
<figure class="align-center ">
<img alt="A piggy bank seen from above beside a prescription box" src="https://images.theconversation.com/files/503453/original/file-20230106-24-vj99yn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/503453/original/file-20230106-24-vj99yn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/503453/original/file-20230106-24-vj99yn.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/503453/original/file-20230106-24-vj99yn.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/503453/original/file-20230106-24-vj99yn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/503453/original/file-20230106-24-vj99yn.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/503453/original/file-20230106-24-vj99yn.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">For over 50 years, drug companies have been suggesting that access to medications will be at risk every time governments do something that threatens their profits.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Do Canadians wait longer for new drugs? If the comparison is to patients in the U.S. or the European Union (EU), then the answer is yes. </p>
<p>Why is the wait longer? After companies submit drugs for approval in the U.S. or the EU, <a href="https://www.cirsci.org/publications/cirs-rd-briefing-81-new-drug-approvals-in-six-major-authorities-2011-2020/">they take an extra year</a> before submitting them to Health Canada. Is that wait because of Canadian drug prices? No. Drug prices are higher in Switzerland than in Canada, but the wait to get drugs approved in Switzerland is also longer than in Canada. </p>
<p>If drug prices were the reason for the wait, then companies should be submitting applications sooner in Switzerland compared to Canada.</p>
<p>In Canada, newly approved drugs are available for people with private insurance <a href="https://doi.org/10.9778/cmajo.20220063">about a year</a> before they can be prescribed to people covered by provincial/territorial drug formularies. But a substantial proportion of that time difference is in the hands of drug companies.</p>
<p>If pharma companies want to get their drugs publicly covered, they first have to submit them to the <a href="https://www.cadth.ca/about-cadth">Canadian Agency for Drugs and Technologies in Health</a> (CADTH). CADTH then does a value-for-money audit and makes a recommendation to the provinces and territories about funding. </p>
<p>In an effort to speed up decision-making about whether the public should pay for new drugs, ever since April 2018 companies can <a href="https://doi.org/10.3389/fphar.2019.00196">submit applications to CADTH up to 180 days</a> before Health Canada approves the drugs. But instead of taking full advantage of this provision, <a href="http://doi.org/10.9778/cmajo.20220063">companies only submit a median of 13 days before approval</a>, adding 5.5 months to the time it takes to make a final decision. </p>
<h2>Protecting profits</h2>
<p>Drug companies have been making threats for over 50 years every time governments do something that threatens their profits. </p>
<p>In 1972, the NDP government of Manitoba passed a law making it mandatory for pharmacists to substitute cheaper generic drugs for those named on prescriptions, unless prohibited by the physician writing the prescription. Furthermore, the substitute could not be sold at a price higher than that of the lowest priced equivalent drug. After this legislation passed, the <a href="https://utorontopress.com/9781442619609/private-profits-versus-public-policy/">president of the industry association made a thinly veiled threat to the Manitoba government</a>:</p>
<blockquote>
<p>“It will remain to be seen how much value would be put on the Manitoba market by research-oriented companies. It is each company’s decision whether the size of their Manitoba market will merit the cost of properly servicing that market. If they can’t meet the prices they could be forced out of business.”</p>
</blockquote>
<p>After the Liberal government in Ontario passed legislation in 2017 requiring companies to report how much money they gave to doctors, hospitals and other health care personnel and institutions, <a href="https://www.theglobeandmail.com/canada/article-ford-pcs-leave-drug-company-transparency-law-in-limbo/">IMC made the same threat</a> about not launching new drugs in Canada because of the regulatory burden of having to make reports.</p>
<p>Now, they are making a similar threat based on potentially lower drug prices in Canada.</p>
<p>Drug companies make threats to maintain their ability to make <a href="https://doi.org/10.1001/jama.2020.0442">extraordinarily high profits</a>. The rest of us need to stand up for the right of patients to get drugs at affordable prices.</p><img src="https://counter.theconversation.com/content/197335/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2019-2022, Joel Lexchin received payments for writing a brief on the role of promotion in generating prescriptions for Goodmans LLP and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p>The pharma industry claims lower prescription drug prices will mean less access to new medication for Canadians. It’s an old threat that pits profits against patients’ rights to affordable drugs.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, CanadaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1967192022-12-21T19:15:07Z2022-12-21T19:15:07ZLecanemab: Experimental drug is a ray of hope for Alzheimer’s disease<figure><img src="https://images.theconversation.com/files/501936/original/file-20221219-12-30f5kc.jpg?ixlib=rb-1.1.0&rect=0%2C2%2C997%2C663&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Lecanemab is an antibody that attaches to beta-amyloid proteins accumulated in the brain and allows the immune system to get rid of them.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>On Nov. 30, Eisai and Biogen announced the <a href="https://eisai.mediaroom.com/2022-11-29-EISAI-PRESENTS-FULL-RESULTS-OF-LECANEMAB-PHASE-3-CONFIRMATORY-CLARITY-AD-STUDY-FOR-EARLY-ALZHEIMERS-DISEASE-AT-CLINICAL-TRIALS-ON-ALZHEIMERS-DISEASE-CTAD-CONFERENCE">results of their latest phase 3 clinical trial in Alzheimer’s disease</a>. The verdict: an 18-month treatment with lecanemab slows functional and cognitive loss by 27 per cent in people with mild cognitive impairment or mild dementia due to Alzheimer’s disease. <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2212948">The study results were also published in the <em>New England Journal of Medicine</em></a>.</p>
<p>The pharmaceutical company Eisai claims that unlike the drugs already approved for Alzheimer’s treatment, this one is able to slow down the disease rather than just reduce its symptoms.</p>
<p>This good news, however, is only the first step towards finding a real cure for Alzheimer’s.</p>
<p>As neuroscience experts specializing in the study of Alzheimer’s, we are following the search for treatments for this disease very closely.</p>
<h2>Promising but modest results</h2>
<p>Lecanemab is an antibody that attaches to beta-amyloid proteins accumulated in the brain and allows the immune system to get rid of them. In Alzheimer’s, this protein forms aggregates and is thought to contribute to the <a href="https://pubmed.ncbi.nlm.nih.gov/27025652/">initial progression of the disease</a>.</p>
<p>Eisai therefore selected people with the greatest chance of benefitting from the treatment: those in the early stages of the disease or with mild cognitive impairment who have large accumulations of beta-amyloid. This is the case for about <a href="https://pubmed.ncbi.nlm.nih.gov/35099509/">seven out of eight people with a diagnosis of Alzheimer’s and half of those living with mild cognitive impairment</a>. After 18 months of treatment one-third of those treated were at normal levels of beta-amyloid.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/500815/original/file-20221213-22444-zd3iu5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="elderly people make a puzzle" src="https://images.theconversation.com/files/500815/original/file-20221213-22444-zd3iu5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/500815/original/file-20221213-22444-zd3iu5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/500815/original/file-20221213-22444-zd3iu5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/500815/original/file-20221213-22444-zd3iu5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/500815/original/file-20221213-22444-zd3iu5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/500815/original/file-20221213-22444-zd3iu5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/500815/original/file-20221213-22444-zd3iu5.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">An 18-month treatment with lecanemab slows functional and cognitive loss by 27 per cent in people with mild Alzheimer’s disease or mild Alzheimer’s-related cognitive impairment.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>This is <a href="https://pubmed.ncbi.nlm.nih.gov/34151810/">not the first time a product has gotten rid of beta-amyloid</a>, but it is the first time a treatment has led to statistically clear cognitive and functional benefits. However, the effect is small: on <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3409562/">the 18-point clinical dementia rating scale</a>, treated people lost half a point. The actual impact on the life of a treated person is therefore modest. As Alzheimer’s symptoms progress slowly in the early stages of the disease, it will be important to determine whether the effect continues after more than 18 months.</p>
<h2>Worrisome side effects</h2>
<p>The treatment is also not all good news. It led to a 25 per cent faster shrinkage of the brain. Researchers have attributed this atrophy to the removal of beta-amyloid. However, this is not a universally accepted idea, as the brain levels of <a href="https://pubmed.ncbi.nlm.nih.gov/34224184/">beta-amyloid are too small to explain such shrinkage</a>. The consequences of such shrinkage are unknown.</p>
<p>One-sixth of those treated developed cerebral edema — a build-up of water indicating inflammation. The treatment also led to twice as many brain hemorrhages — about one in six — compared to those who received the placebo. However, only one in 30 people actually experienced symptoms related to these two abnormalities. Although mild microhemorrhages are quite common in the elderly, these could reduce the brain’s ability to adapt. This could therefore <a href="https://jamanetwork.com/journals/jamaneurology/article-abstract/2526492">increase the brain’s vulnerability to diseases such as Alzheimer’s</a>.</p>
<p>Fortunately, subgroups of patients may benefit more from this treatment. Men and people aged 75 and over had a more than 40 per cent reduction in cognitive decline. People without the e4 variant of the APOE gene, the <a href="https://www.science.org/doi/abs/10.1126/science.8346443">main risk factor for Alzheimer’s</a>, experienced fewer side effects while having a greater slowdown in the progression of the disease.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/m_ryJzQBYOY?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">The drug lecanemab reduces cognitive decline in people with Alzheimer’s, but it also causes sometimes severe side effects.</span></figcaption>
</figure>
<p>Conversely, people carrying two copies of APOE e4 — from both parents — were six times more likely to develop symptoms from brain hemorrhage or edema. In addition, these people did not, on average, experience any positive effects from lecanemab. Having a single copy of APOE e4 seems to allow people to benefit from the treatment while slightly increasing the risk of side effects.</p>
<p>These data offer hope that health-care professionals will be able to select patients who are most likely to benefit from the treatment.</p>
<h2>A resource-intensive treatment</h2>
<p>All indications are that lecanemab will be resource intensive. First, before giving lecanemab to a patient, we need to ensure that his/her brain contains high levels of beta-amyloid. This will require expensive imaging equipment in addition to a team of well-trained professionals.</p>
<p>The antibody must also be injected once every two weeks, requiring more involvement from patients, their relatives and health professionals. To manage the risk of side effects, follow-up imaging will also be essential. Added to this is the cost of the drug itself, which has not yet been announced. According to analysts, this could be <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/eisai-biogen-alzheimers-drug-could-be-available-some-next-year-2022-11-30/#:%7E:text=Several%20estimated%20lecanemab%20may%20be%20priced%20at%20around%20%2420%2C000%20per%20year">nearly US$20,000 per year</a>.</p>
<p>In short, the health-care system and the research community will have to dedicate significant resources to offer this new treatment equitably to the greatest number of people. More medical and neuropsychological follow-ups will be needed, new brain imaging infrastructures will have to be built and specialized personnel will have to be trained.</p>
<p>We must hope that this new treatment will be worth the effort.</p>
<p>Let’s also hope that future clinical trial results will report greater efficacy in women and in people with APOE e4.</p>
<p>After all, lecanemab is just the beginning, and much more will be needed to truly cure Alzheimer’s disease.</p><img src="https://counter.theconversation.com/content/196719/count.gif" alt="La Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Frederic Calon has received funding from the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), the Canadian Foundation for Innovation, the Alzheimer Society of Canada and the Fonds de recherche du Québec - Santé (FRQS).</span></em></p><p class="fine-print"><em><span>Étienne Aumont has received funding from the Canadian Institutes of Health Research.</span></em></p>An 18-month treatment with lecanemab slows functional and cognitive loss by 27 per cent in people with mild Alzheimer’s disease. But this is only the first step towards a real cure.Frederic Calon, Professeur, Université LavalÉtienne Aumont, Étudiant au doctorat en psychologie, Université du Québec à Montréal (UQAM)Licensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1812352022-06-05T12:22:00Z2022-06-05T12:22:00ZWe still need a vaccine patent waiver, but not the one on offer at the World Trade Organization meeting<figure><img src="https://images.theconversation.com/files/466910/original/file-20220603-17-5nwz4k.jpg?ixlib=rb-1.1.0&rect=382%2C238%2C4930%2C3241&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Global Justice campaigners in London stand by fake coffins to highlight global COVID-19 deaths. If pharma companies waived intellectual property rights, it would be easier for low- and middle-income countries to access COVID-19 vaccines.
</span> <span class="attribution"><span class="source">(AP Photo/Alastair Grant)</span></span></figcaption></figure><p>In mid-June, the <a href="https://www.wto.org/english/thewto_e/minist_e/mc12_e/mc12_e.htm">World Trade Organization (WTO) will meet</a> to finish negotiations to waive certain sections of the agreement on Trade Related Intellectual Property Rights (TRIPS). However, it is not the TRIPS waiver originally proposed 18 months ago by member states South Africa and India, which would have allowed countries to produce lower-cost generic vaccines and other COVID-19 medical tools without the risk of legal trade challenges.</p>
<p>The opposition to the waiver from a few WTO member states — home to the pharma companies holding monopoly patent rights over the vaccines — has resulted in “<a href="https://doi.org/10.1016/S0140-6736(22)00328-2">vaccine apartheid</a>” (rich countries buying up all the early supplies) and “<a href="https://www.thenation.com/article/economy/pfizer-pandemic-profiteering/">vaccine profiteering</a>” (companies making multi-billion-dollar profits and fighting every effort to allow generic competition). </p>
<p>Vaccine supply is no longer the main issue. Pharma companies still holding the vaccine patents can now produce enough for everyone — though not necessarily at affordable prices — and have described the <a href="https://healthpolicy-watch.news/with-covid-vaccine-supply-outstripping-vaccination-rates-pharma-giants-question-pursuit-of-ip-waiver/">idea of a TRIPS waiver now as “insane” and “unproductive</a>.” </p>
<p>But for the scores of WTO member states and thousands of global health researchers still supporting the waiver <a href="https://theconversation.com/covid-19-drug-and-vaccine-patents-are-putting-profit-before-people-149270">(myself included)</a>, getting the WTO to approve one at its upcoming June ministerial meeting remains important. Just not the waiver that’s on the negotiating table. </p>
<h2>Worse than no waiver</h2>
<p><a href="https://www.wto.org/english/news_e/news22_e/trip_06may22_e.htm">The current version</a> is the outcome of discussions involving the two original proposing members, the United States and the European Union. It is restricted to vaccines — a U.S. request — ignoring, for now at least, therapeutics, diagnostics and other essential COVID-19-related health products. </p>
<figure class="align-center ">
<img alt="Hands holding a syringe and vial of vaccine" src="https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/466905/original/file-20220603-15469-2mn4y6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">The waiver under negotiation puts a time limit on the waived obligations.</span>
<span class="attribution"><span class="source">(AP Photo/Michel Euler)</span></span>
</figcaption>
</figure>
<p>It requires generic manufacturers to identify all related patents, which is impossible given vaccines’ complex “<a href="https://doi.org/10.1007/s10551-021-04873-6">patent thickets</a>” (overlapping patent rights), and something not required under present TRIPS rules. It puts a time limit on the waived obligations, as though pandemics are calendar-savvy. </p>
<p>While it removes barriers to generic companies exporting to developing countries that lack their own manufacturing capacity, it excludes countries that supplied more than 10 per cent of global vaccine exports in 2021, namely, China. </p>
<p>A shadow of its original intent, the new waiver is <a href="https://twn.my/title2/wto.info/2022/ti220514.htm">endorsed only by the EU, with support from the WTO director-general</a>. </p>
<h2>Why the new waiver proposal should be opposed</h2>
<p>If enacted as currently drafted, the new waiver sets a precedent that will restrict the ability of countries with the capacity to mass produce therapeutics, diagnostics and even personal protective equipment. This would apply to the still-with-us COVID-19 pandemic and for any new zoonotic outbreaks that are <a href="https://theconversation.com/future-infectious-diseases-recent-history-shows-we-can-never-again-be-complacent-about-pathogens-177746">almost certainly on the near horizon</a>. </p>
<p>Without a meaningful waiver, new variant-ready vaccines <a href="https://medicalxpress.com/news/2022-04-pfizer-eyes-covid-vaccine-variants.html">expected later this year</a> are likely to be gobbled up once more by high-paying rich countries, with the poorer ones left with older less-effective versions. </p>
<figure class="align-center ">
<img alt="Vials of vaccine with purple caps shot from above" src="https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/466908/original/file-20220603-9439-4opry1.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Pharma companies holding patents can now produce enough vaccine for everyone, though not necessarily at affordable prices.</span>
<span class="attribution"><span class="source">(AP Photo/Achmad Ibrahim)</span></span>
</figcaption>
</figure>
<p>The same scenario applies to therapeutics such as <a href="https://www.bloomberg.com/news/articles/2022-04-22/covid-antiviral-pills-seen-surging-after-slow-initial-uptake">Pfizer’s antiviral drug, Paxlovid</a>. Most of its current supply will go to wealthy countries that can afford the high prices Pfizer charges. Pfizer will allow licences for generic versions to be produced for distribution to 95 developing countries, but not until 2023. </p>
<p>Moderna, the other mRNA vaccine leader, is busy <a href="https://www.aljazeera.com/opinions/2022/3/16/modernas-profits-show-why-big-pharma-cant-meet-our-health-needs">registering patents for its vaccine in South Africa</a> as that country, with WTO support, is close to copying Moderna’s recipe, the know-how for which it plans to share publicly. Moderna’s new patents could <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-patent-application-raises-fears-africa-covid-vaccine-hub-2022-02-17/">jeopardize this effort</a>. The company meanwhile has plans to create its own mRNA plant in Kenya to supply the African continent <a href="https://socialeurope.eu/control-the-vampire-companies">on its own profitable terms</a>. </p>
<p>On May 25, Pfizer announced that it would eventually provide all “<a href="https://www.weforum.org/agenda/2022/05/pfizer-launches-an-accord-for-a-healthier-world-a-call-for-action-to-improve-health-equity-globally/?utm_source=sfmc&utm_medium=email&utm_campaign=2778051_Am22-AgendaDaily-26May2022&utm_term=&emailType=Agenda%20Week">current and future patent-protected medicines on a not-for-profit basis” to 45 lower-income countries</a>, beginning with five countries in Africa. </p>
<p>The company’s decision is welcome, but questions remain. Will Pfizer forego lucrative sales of its current and future drugs to rich countries in order to supply (eventually) the 1.2 billion people living in the world’s poorest nations? Or will these countries have to wait until the paying world’s 6.7 billion people have had their supply needs met? </p>
<h2>Current property rights not fit for global health purpose</h2>
<p>The bottom line: for-profit companies should not be setting public health policy during global health emergencies. Individual corporate decisions to supply life-saving health innovations at cost in otherwise unprofitable markets is not a sustainable or ethical solution. </p>
<p>Bluntly stated: companies’ intellectual property rights should not be allowed to trump people’s health rights. </p>
<figure class="align-center ">
<img alt="A crowd outdoors with people holding blue signs reading 'Support patent waivers on COVID-19 vaccines'" src="https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=417&fit=crop&dpr=1 600w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=417&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=417&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=524&fit=crop&dpr=1 754w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=524&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/466911/original/file-20220603-11-mv11bv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=524&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Activists support patent waivers on COVID-19 vaccines in front of the European Union office during an EU summit in Kyiv, Ukraine, on Oct. 12, 2021.</span>
<span class="attribution"><span class="source">(AP Photo/Efrem Lukatsky)</span></span>
</figcaption>
</figure>
<p>Investment into new health products means taking risks, and it warrants some reward. However, much of the groundwork in pharmaceutical research is publicly funded. </p>
<p>This was certainly the case with COVID-19 vaccines, and one of the reasons why many organizations argued that these discoveries <a href="https://peoplesvaccine.org/">should be considered “people’s vaccines” and treated as public goods</a>. Governments need to place <a href="https://www.who.int/publications/m/item/governing-health-innovation-for-the-common-good">conditions on the financial support they give to health research</a> to ensure that the results are more equitably shared. </p>
<p>In the case of public health emergencies, such as pandemics, this should include requirements that companies forego their monopoly property rights, accept negotiated royalties for their efforts and share their knowledge. </p>
<p>President Joe Biden’s administration recently took a step in this direction. It <a href="https://www.hhs.gov/about/news/2022/05/12/nih-licenses-covid-19-research-tools-early-stage-technologies-who-program.html">licensed 11 COVID-19 inventions</a> that arose from in-house research at the National Institutes of Health, including early-stage development of the stabilized spike protein that forms the base of mRNA vaccines. </p>
<p>Described as “<a href="https://www.science.org/content/article/pretty-big-deal-u-s-makes-covid-19-technologies-available-use-developing-countries">a pretty big deal</a>” by an advocate of shared intellectual property, the licenses will be administered by the non-profit <a href="https://medicinespatentpool.org/">Medicines Patent Pool</a> that negotiates low royalty costs for generic manufacturers, so inventors will still get some reward. </p>
<p>But this early-stage knowledge-sharing is insufficient to enable full development of medical innovations, which requires drug companies holding patents on the finished, commercialized vaccines and COVID-19-related technologies to waive these rights and to share their technical know-how. </p>
<h2>Canada and the June WTO meeting</h2>
<p>As with the rest of the world, Canada’s attention is moving away from COVID-19 to <a href="https://www.cbc.ca/news/business/canada-inflation-april-1.6457520">inflation fears</a> and <a href="https://theconversation.com/why-did-russia-invade-ukraine-faqs-about-the-conflict-that-has-shocked-the-world-177963">Russia’s war against Ukraine</a>. With surprisingly little media coverage, the government began holding <a href="https://www.ourcommons.ca/Committees/en/FAAE/StudyActivity?studyActivityId=11504514">parliamentary committee hearings on vaccine equity</a> this past spring. Still, it remains uncommitted on the waiver, as it has since the original waiver was proposed. </p>
<figure class="align-center ">
<img alt="A globe and a syringe against a blue background" src="https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&rect=748%2C30%2C3341%2C2501&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=398&fit=crop&dpr=1 600w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=398&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=398&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=501&fit=crop&dpr=1 754w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=501&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/466903/original/file-20220603-26-bpuy54.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=501&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Companies’ intellectual property rights should not be allowed to trump people’s health rights.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Health and civil society groups, meanwhile, remain committed to urging the government to make the right ethical and health protective decision. They are calling on Canada to <a href="https://policyalternatives.ca/newsroom/updates/canada-should-reject-compromise-proposal-trips-waiver-its-present-form-civil">use the June WTO meeting to bring the deeply flawed new waiver proposal closer to the original one</a>. </p>
<p>There is still a need for a decent TRIPS waiver to ensure that intellectual property rights do not get in the way of rapid and equitable access to medicines or any other essential health innovations. That must be one of the key lessons we take from our COVID-19 experience.</p><img src="https://counter.theconversation.com/content/181235/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ronald Labonte receives funding from the Canadian Institutes of Health Research, and is a member of the Steering Council of the People's Health Movement, which advocates for global health equity.</span></em></p>Waiving patent rights on COVID-19 vaccines and drugs is still crucial to ensure access globally, but the waiver on the table at the June World Trade Organization meeting doesn’t do the job.Ronald Labonte, Professor and Distinguished Research Chair, Globalization and Health Equity, L’Université d’Ottawa/University of OttawaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1749672022-01-24T16:03:16Z2022-01-24T16:03:16ZLower drug prices are a priority for Canadians, but not for the federal government<figure><img src="https://images.theconversation.com/files/441912/original/file-20220121-8679-1cfzhwc.jpg?ixlib=rb-1.1.0&rect=58%2C100%2C5330%2C3631&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Changes to the Patented Medicine Prices Review Board regulations, which are intended to help lower drug costs in Canada, were originally scheduled to take effect in July 2020.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><iframe style="width: 100%; height: 175px; border: none; position: relative; z-index: 1;" allowtransparency="" src="https://narrations.ad-auris.com/widget/the-conversation-canada/lower-drug-prices-are-a-priority-for-canadians--but-not-for-the-federal-government" width="100%" height="400"></iframe>
<p>Once again, the federal minister of health has postponed <a href="https://www.canada.ca/en/health-canada/news/2021/12/statement-from-the-minister-of-health-on-the-deferral-of-coming-into-force-of-the-regulations-amending-the-patented-medicines-regulations.html">changes to the Patented Medicine Prices Review Board (PMPRB) regulations</a> for another six months until July 1, 2022. </p>
<p>The excuse is that bringing the amendments into force during the COVID-19 pandemic requires preparedness and consultation and the government needs to further engage stakeholders — the pharmaceutical industry and its allies.</p>
<p>The process of changing the regulations started in June 2016 when the PMPRB released a <a href="http://www.pmprb-cepmb.gc.ca/CMFiles/Consultations/DiscussionPaper/PMPRB_DiscussionPaper_June2016_E.pdf">public discussion paper</a>. Changes were necessary because of the high cost of drugs in Canada: The PMPRB reported in 2019 that only the <a href="https://www.canada.ca/content/dam/pmprb-cepmb/documents/reports-and-studies/annual-report/2019/pmprb-ar-2019-en.pdf">United States, Switzerland and Germany had higher drug prices</a>. On a per capita basis, <a href="https://www.oecd-ilibrary.org/docserver/ae3016b9-en.pdf?expires=1640634504&id=id&accname=guest&checksum=BB9D07F986EF2A8A219322378B5291C5">Canada spent the third-highest amount in the world</a> on drugs in 2021, according to the Organization for Economic Co-operation and Development. </p>
<p>Lowering drug prices was part of the <a href="https://www.budget.gc.ca/2019/docs/themes/pharmacare-assurance-medicaments-en.html">groundwork for a national pharmacare plan</a> — although pharmacare gets only a passing mention in the <a href="https://pm.gc.ca/en/mandate-letters/2021/12/16/minister-health-mandate-letter">latest mandate letter</a> from Prime Minister Justin Trudeau to the new Health Minister Jean-Yves Duclos.</p>
<p>Finally, the multinational drug companies were not living up to their end of the bargain: in 1987 they agreed to spend 10 per cent of sales revenue on research and development in Canada in return for Canada changing its rules about drug patents. By 2019, that figure had <a href="https://www.canada.ca/content/dam/pmprb-cepmb/documents/reports-and-studies/annual-report/2019/pmprb-ar-2019-en.pdf">shrunk to 3.9 per cent</a>.</p>
<h2>Delayed by two years</h2>
<p>The PMPRB changes were initially supposed to come into effect on July 1, 2020, but were delayed for six months. The reasons, <a href="https://www.pharmainbrief.com/2020/06/pmprb-update-amendments-delayed-new-guidelines-consultation-announced-and-judicial-review-heard/">according to the federal government</a>, were “to minimize the imposition of new administrative burden on industry” and to give stakeholders more time to provide feedback because of the impact of the pandemic. </p>
<figure class="align-center ">
<img alt="A medicine bottle tipped on its side, with white caplets arranged in the shape of a dollar sign" src="https://images.theconversation.com/files/441926/original/file-20220121-17-x9agmc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/441926/original/file-20220121-17-x9agmc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=333&fit=crop&dpr=1 600w, https://images.theconversation.com/files/441926/original/file-20220121-17-x9agmc.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=333&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/441926/original/file-20220121-17-x9agmc.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=333&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/441926/original/file-20220121-17-x9agmc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=419&fit=crop&dpr=1 754w, https://images.theconversation.com/files/441926/original/file-20220121-17-x9agmc.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=419&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/441926/original/file-20220121-17-x9agmc.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=419&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Efforts to lower drug prices were part of the groundwork for a national pharmacare plan.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Fast forward six months and there’s another six-month delay. This time, a <a href="https://www.ctvnews.ca/health/health-canada-delays-drug-pricing-reforms-citing-covid-19-challenges-for-manufacturers-1.5258523">spokesperson for Health Canada</a> said that the industry needed more time to adjust to new reporting requirements while dealing with the challenges posed by the COVID-19 pandemic. </p>
<p>On June 24, 2021, seven days before the changes were to start, the federal government decided that industry needed even more time because of the pandemic. On that occasion, Health Canada said, “<a href="https://www.theglobeandmail.com/politics/article-ottawa-delays-drug-pricing-changes-a-third-time-citing-covid-19/">It is not anticipated that further delaying these amendments will be needed</a>.” But as the <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/canada-delay-drug-price-reforms-by-six-months-cites-pandemic-2021-12-23/">announcement on Dec. 23</a> showed, another delay was necessary.</p>
<h2>Lobbying efforts</h2>
<p>Are the pandemic and the need for more discussions the only reasons for these repeated delays? The multinational drug companies, as represented by their lobby group Innovative Medicines Canada (IMC), have been very vocal in their opposition to the changes. </p>
<figure class="align-right ">
<img alt="Innovation, Science and Industry Minister Francois-Philippe Champagne standing with a finger raised in the House of Commons" src="https://images.theconversation.com/files/441922/original/file-20220121-23-vilfiz.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/441922/original/file-20220121-23-vilfiz.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=420&fit=crop&dpr=1 600w, https://images.theconversation.com/files/441922/original/file-20220121-23-vilfiz.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=420&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/441922/original/file-20220121-23-vilfiz.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=420&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/441922/original/file-20220121-23-vilfiz.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=528&fit=crop&dpr=1 754w, https://images.theconversation.com/files/441922/original/file-20220121-23-vilfiz.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=528&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/441922/original/file-20220121-23-vilfiz.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=528&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Innovation, Science and Industry Minister François-Philippe Champagne is reportedly rebuilding bridges with Big Pharma.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Patrick Doyle</span></span>
</figcaption>
</figure>
<p><a href="http://innovativemedicines.ca/wp-content/uploads/2018/02/20180212_IMC_CG1_Submission_Regulations_Amending_the_Patented_Medicines_Regulations_Final.pdf">IMC disputed the need for them</a>, the benefits that would result and claimed that drug companies would either not launch or delay the launch of new drugs in Canada. The only evidence for the latter threat was a <a href="https://lifesciencesontario.ca/wp-content/uploads/2020/06/EN_LSO_Global-Launch-Benchmarking_Webinar-June22-20_Final.pdf">report from Life Sciences Ontario</a>, an organization whose membership includes multiple multinational drug companies.</p>
<p>If the pandemic meant more discussions were necessary, it also meant more lobbying by the industry. According to an investigative article in <a href="https://breachmedia.ca/how-canada-became-a-vaccine-villain/"><em>The Breach</em></a>, an online media outlet, IMC lobbied elected representatives and government officials 55 times in 2021. </p>
<blockquote>
<p>“Lobbyists for U.S.-based pharmaceutical giants Pfizer and Johnson & Johnson … paid designated office holders in Canada a combined 116 visits since October 2020.” </p>
</blockquote>
<p>The bulk of the lobbying was to make sure that Canada <a href="http://innovativemedicines.ca/innovative-medicines-canada-cautions-covid-19-trips-ip-waiver/">didn’t support any relaxation of patent standards at the World Trade Organization</a>. But <a href="https://www.theglobeandmail.com/opinion/article-in-battle-between-trudeau-and-big-pharma-over-drug-prices-federal/">in light of reports</a> that then Innovation Minister François-Philippe Champagne had “made it a mission to rebuild bridges with Big Pharma,” <a href="https://lobbycanada.gc.ca/app/secure/ocl/lrs/do/clntSmmrySrch?dpohFullName=FRANCOIS+PHILIPPE+CHAMPAGNE&searchType=Search">some of that lobbying</a> was very likely also around the PMPRB changes. </p>
<p>Besides lobbying and predicting repercussions like delayed drug launches, the industry has also attempted to buy its way out of the changes. IMC offered to <a href="https://www.reuters.com/article/canada-pharmaceuticals-idUSKBN27V0LO">spend $1 billion</a> over 10 years to boost local manufacturing and commercialization, and on new programs to improve access to drugs for rare diseases on the condition that some of the pricing changes be scrapped.</p>
<h2>Vocal opposition</h2>
<p>IMC was <a href="https://www.theglobeandmail.com/business/article-health-canada-delays-drug-pricing-reforms-citing-covid-19-challenges/">backed up by various patient groups</a>. Durhan Wong-Reiger, president and CEO of the Canadian Organization for Rare Disorders (CORD), warned that “draconian” restrictions on drug prices won’t solve Canada’s budget problems. </p>
<p>Chris MacLeod, the founder of the Cystic Fibrosis Treatment Society, said burdensome drug-pricing measures could cut Canada out of the latest COVID-19 vaccines and treatments being developed around the world. </p>
<figure class="align-center ">
<img alt="Shelves of prescription medication at a pharmacy" src="https://images.theconversation.com/files/441925/original/file-20220121-23-1quc7tf.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/441925/original/file-20220121-23-1quc7tf.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=395&fit=crop&dpr=1 600w, https://images.theconversation.com/files/441925/original/file-20220121-23-1quc7tf.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=395&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/441925/original/file-20220121-23-1quc7tf.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=395&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/441925/original/file-20220121-23-1quc7tf.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=496&fit=crop&dpr=1 754w, https://images.theconversation.com/files/441925/original/file-20220121-23-1quc7tf.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=496&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/441925/original/file-20220121-23-1quc7tf.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=496&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Canadians pay some of the highest prescription drug costs in the world.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Ryan Remiorz</span></span>
</figcaption>
</figure>
<p>On its website, <a href="https://www.raredisorders.ca/cord-membership/partners/">CORD lists over 25 drug companies</a> among its “corporate leaders.” The <a href="https://cfadvocacynow.com/">website of the Cystic Fibrosis Treatment Society</a> doesn’t say if it has any relationships with drug companies.</p>
<p>Likewise, a group of “concerned Canadian doctors” recently wrote an opinion piece in the <a href="https://www.thespec.com/opinion/contributors/2021/12/22/press-pause-on-drug-price-policy.html"><em>Hamilton Spectator</em></a>. In it they argued that the federal government should halt implementation of new federal drug pricing regulations until a thorough consultation that includes physicians is undertaken. </p>
<p>Their reasoning is that if the regulations went ahead, Canadians will have increasing difficulty accessing effective new drugs. The article did not mention whether any of the signatories had financial conflicts of interest with drug companies.</p>
<p>Finally, there has been pressure from outside Canada. The <a href="https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/PhRMA_2021-Special-301_Review_Comment-1.pdf">Pharmaceutical Research and Manufacturers of America</a>, the lobby group that represents giant American drug companies, made it clear that in its view the changes “will significantly undermine the marketplace for innovative pharmaceutical products, delay or prevent the introduction of new medicines in Canada and reduce investments in Canada’s life sciences sector.” </p>
<p>In its annual report, the <a href="https://ustr.gov/sites/default/files/files/reports/2021/2021%20Special%20301%20Report%20(final).pdf">Office of the United States Trade Representative</a> warned that the U.S. “will continue to monitor the implementation and effects of … changes to the Patented Medicine Prices Review Board’s pricing regulations.”</p>
<h2>Rising drug costs for Canadians</h2>
<p>While the federal government has been bowing to the pharmaceutical industry, the amount that Canadians spend on medicines has continued to rise. In 2020, Canadians <a href="https://canjhealthtechnol.ca/index.php/cjht/article/view/mt0001">spent an estimated $32.7 billion</a>, 4.3 per cent more than the previous year. Meanwhile, <a href="https://angusreid.org/pharmacare-2020/">more than two-in-five Canadians are concerned about their ability to afford prescription drugs in 10 years</a>. </p>
<p>A <a href="https://nursesunions.ca/wp-content/uploads/2018/05/2018.04-Body-Count-Final-web.pdf">report from the Canadian Federation of Nurses Unions</a> estimates that the lack of affordability of prescription drugs could be causing 370 to 640 premature deaths due to heart disease every year, and 270 to 420 premature deaths annually of working-age Canadians with diabetes. </p>
<figure class="align-center ">
<img alt="Pharmacist's hands using a pill tray to count green and yellow capsules, with a pill bottle and prescriptions in the background." src="https://images.theconversation.com/files/441923/original/file-20220121-23-og491k.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/441923/original/file-20220121-23-og491k.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=481&fit=crop&dpr=1 600w, https://images.theconversation.com/files/441923/original/file-20220121-23-og491k.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=481&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/441923/original/file-20220121-23-og491k.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=481&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/441923/original/file-20220121-23-og491k.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=605&fit=crop&dpr=1 754w, https://images.theconversation.com/files/441923/original/file-20220121-23-og491k.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=605&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/441923/original/file-20220121-23-og491k.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=605&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">More than two-in-five Canadians are concerned about their ability to afford prescription drugs in 10 years.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Ryan Remiorz</span></span>
</figcaption>
</figure>
<p>Added to these grim numbers, job losses due to the pandemic have meant the loss of benefits including insurance for prescription drugs. An <a href="https://angusreid.org/pharmacare-2020/">Angus Reid poll</a> reports while seven per cent of Canadians gained prescription drug coverage during the year ending in October 2020, 14 per cent lost it during the same year.</p>
<p>Canadians have been waiting more than five years for lower drug prices. It’s time to stop waiting.</p><img src="https://counter.theconversation.com/content/174967/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2019-2021, Joel Lexchin received payments for writing a brief on the role of promotion in generating prescriptions for Goodmans LLP and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p>Changes to Canada’s Patented Medicine Prices Review Board regulations have been postponed for a fourth time in two years as Canadians continue to pay some of the highest drug prices in the world.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, Emergency Physician at University Health Network, Associate Professor of Family and Community Medicine, University of TorontoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1728352021-11-30T22:03:02Z2021-11-30T22:03:02ZDrug companies protest when Health Canada withdraws their products for safety reasons<figure><img src="https://images.theconversation.com/files/434537/original/file-20211129-23-3yrz9a.jpg?ixlib=rb-1.1.0&rect=2%2C31%2C1914%2C1244&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The level of evidence for withdrawing a drug does not appear to affect the pharma company's response.</span> <span class="attribution"><span class="source">(Pixabay)</span></span></figcaption></figure><p>For decades oil companies denied that their products were <a href="https://www.theguardian.com/environment/2021/mar/18/oil-industry-fossil-fuels-air-pollution-documents">harmful to human health</a>. <a href="https://theintercept.com/2021/06/30/epa-pesticides-exposure-opp/">Pesticide companies</a> did the same with their products. We all know how executives from <a href="https://truthinitiative.org/research-resources/tobacco-prevention-efforts/5-ways-tobacco-companies-lied-about-dangers-smoking">cigarette companies lied about the harms from smoking</a>.</p>
<p>Are drug companies any different? When drugs are taken off the market because they are either unsafe or don’t work, do companies admit that there are problems? There is certainly some evidence that companies deny the evidence.</p>
<p>Researchers in the United States <a href="https://doi.org/10.1056/NEJMoa072761">published a meta-analysis</a> in the <em>New England Journal of Medicine</em> (<em>NEJM</em>) in 2007 showing an association between the diabetes drug rosiglitazone and a significant increase in the risk of a heart attack. The <a href="https://www.natap.org/2007/HIV/052107_03.htm">response from GlaxoSmithKline</a>, the maker of the drug, was that the company “strongly disagrees with the conclusions reached in the <em>NEJM</em> article, which are based on incomplete evidence and a methodology that the author admits has significant limitations.” </p>
<p>In another case, a 2001 <a href="https://doi.org/10.1001/jama.286.8.954">article in <em>JAMA: The Journal of the American Medical Association</em></a> raised “a cautionary flag about the risk of cardiovascular events with COX-2 inhibitors,” a type of non-steroidal anti-inflammatory drug used to treat pain and inflammation. Merck was the company selling one of these drugs and an <a href="https://doi.org/10.1001/jama.286.22.2808">employee of Merck Research Laboratories and a Merck consultant</a> claimed that “the analysis provides no substantial support for their conclusion.”</p>
<p>But these might have been isolated examples. In a <a href="https://doi.org/10.3233/JRS-210013">recently published article</a>, I set out to answer the question in a systematic manner.</p>
<h2>Withdrawn drugs</h2>
<p>As a first step, I compiled a list of all the drugs that Health Canada had pulled from the shelves since 1990 either because they had serious safety problems or because they didn’t work. Putting that list together was not easy because of the way that Health Canada organizes information. I had to go through thousands of safety notices and warnings since 2000 on <a href="https://recalls-rappels.canada.ca/en/search/site?f%5B0%5D=audience%3A216&f%5B1%5D=category%3A180">Health Canada’s website</a>, and then combined what I found with the information in an <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4085091/">article that I published in 2014</a>. </p>
<p>In the end, I had the names of 31 drugs. Then I looked for either press releases from the companies about those drugs or articles containing direct quotations or paraphrases of company statements, and found material about 22 drugs.</p>
<p>Almost half the time (10 of 22 drugs), the companies disagreed with the decision to withdraw the drug from the market, and in just under one-third (seven of 22 cases) they agreed with the decision. In the other five cases they felt that the drug could have been kept on the market with restrictions or said that they might reintroduce the drug.</p>
<figure class="align-center ">
<img alt="Exterior shot of office building housing Bayer Healthcare's North American headquarters in Whippany, N.J." src="https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Bayer had no objections when Health Canada withdrew the company’s cholesterol drug from the market in 2001.</span>
<span class="attribution"><span class="source">(AP Photo/Julio Cortez)</span></span>
</figcaption>
</figure>
<p>Here’s what <a href="https://www.thestar.com/news/2007/10/04/health_canada_pulls_arthritis_drug_prexige.html">Novartis said about</a> its anti-inflammatory drug Prexige, which was linked to cardiac deaths: “We’re disappointed with Health Canada’s decision. We don’t agree with the assessment of the data.” </p>
<p>A <a href="https://www.thestreet.com/investing/stocks/bristol-myers-quits-on-antidepressant-10161474">Bristol-Myers spokesman</a> said the company “still believes that prescribing physicians believe Serzone has a role to play in the treatment of depression.” Serzone was associated with liver damage.</p>
<p>On the other hand, a minority of companies had no objections to the action taken by Health Canada. <a href="https://www.cmaj.ca/content/cmaj/165/5/632.1.full.pdf">Bayer’s Canadian general manager</a> said in an interview in 2001 about the withdrawal of a cholesterol drug, “We have taken the responsible route based on increased reports of side effects.”</p>
<p>The strength of the evidence that leads to decisions that a drug is too unsafe to be left on the market can vary significantly, but that didn’t seem to affect what companies had to say. In the three cases with the strongest evidence for a withdrawal, companies agreed with the withdrawal only once.</p>
<p>It does appear that companies have recently become less defensive about their drugs. Up until 2009, they objected to Health Canada’s decision nine out of 14 times, whereas since then they have agreed in five out of eight cases.</p>
<h2>The need for transparency</h2>
<p>There are many, non-exclusive reasons why a company might defend its drug: a commercial motivation to see the drug brought back onto the market; defending the corporate image and integrity; a different scientific interpretation about the nature of the evidence used to withdraw the drug from the market; and an agreement about the safety problem but a different assessment about the overall benefit-to-harm ratio of the drug.</p>
<figure class="align-center ">
<img alt="Pills arranged in the shape of a question mark against a yellow background" src="https://images.theconversation.com/files/434545/original/file-20211129-27-1ka2m2h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/434545/original/file-20211129-27-1ka2m2h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/434545/original/file-20211129-27-1ka2m2h.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/434545/original/file-20211129-27-1ka2m2h.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/434545/original/file-20211129-27-1ka2m2h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/434545/original/file-20211129-27-1ka2m2h.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/434545/original/file-20211129-27-1ka2m2h.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Health Canada should be completely transparent about how it evaluates safety information and makes safety decisions.</span>
<span class="attribution"><span class="source">(Pexels/Anna Shvets)</span></span>
</figcaption>
</figure>
<p>Finally, does it really matter if companies object? After all, the drug is still no longer being sold. </p>
<p>The answer is yes. It’s important for the public to have confidence in the rigour of regulators’ decisions. For example, documents released by the U.S. Food and Drug Association (FDA) showed that drug company <a href="https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/204042Orig1s026.pdf">Janssen engaged in “extensive” efforts with the FDA</a> over the wording of a safety warning about the risk of lower limb amputation associated with the use of canaglifloxin, a drug used in the treatment of diabetes. Due to the redaction of large sections of the document, it is not possible to know how extensive the changes were. </p>
<p>Health Canada typically <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-document-industry-issuance-health-professional-communications-public-communications-market-authorization-holders-health-canada-2010.html">engages in interactions with companies</a> before taking any action with respect to safety issues. The frequent defence of safety by companies raises the question about what effect, if any, the positions they take during interactions with Health Canada have on eventual safety actions that Health Canada takes.</p>
<p>The 2011 <a href="https://publications.gc.ca/collections/collection_2012/bvg-oag/FA1-2011-2-4-eng.pdf">Auditor General’s report</a> pointed to serious problems in the way that Health Canada communicates with the public and health-care professionals about drug safety problems, such as not disclosing information on the status of conditionally approved drugs.</p>
<p>In order to reassure Canadians that their interests are coming first, Health Canada should be completely transparent about how it evaluates safety information and makes safety decisions. We need to know that companies’ claims about the safety of their products are not altering decisions that Health Canada makes.</p><img src="https://counter.theconversation.com/content/172835/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2018-2021, Joel Lexchin received payments for being on a panel at the American Diabetes Association, for talks at the Toronto Reference Library, for writing a brief in an action for side effects of a drug for Michael F. Smith, Lawyer and a second brief on the role of promotion in generating prescriptions for Goodmans LLP and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p>When drugs are taken off the market because they are either unsafe or don’t work, do pharma companies admit that there are problems? Or do they deny the evidence?Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, Emergency Physician at University Health Network, Associate Professor of Family and Community Medicine, University of TorontoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1694432021-10-29T12:37:26Z2021-10-29T12:37:26ZAntibiotic resistance is at a crisis point – government support for academia and Big Pharma to find new drugs could help defeat superbugs<figure><img src="https://images.theconversation.com/files/428912/original/file-20211027-17-sshvdh.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2119%2C1414&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Bacteria that are resistant to every available antibiotic in the U.S. already exist.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/bacteria-royalty-free-image/909752640">Rodolfo Parulan Jr/Moment via Getty Images</a></span></figcaption></figure><p>Antibiotic resistance poses one of the most important health challenges of the 21st century. And time has already run out to stop its dire consequences.</p>
<p>The rise of <a href="https://www.cdc.gov/drugresistance/biggest-threats.html">multidrug-resistant bacteria</a> has already led to a significant increase in human disease and death. The U.S. Centers for Disease Control and Prevention estimates that approximately <a href="https://www.cdc.gov/drugresistance/biggest-threats.html">2.8 million people</a> worldwide are infected with antibiotic-resistant bacteria, accounting for 35,000 deaths each year in the U.S. and <a href="https://www.who.int/news/item/29-04-2019-new-report-calls-for-urgent-action-to-avert-antimicrobial-resistance-crisis">700,000 deaths around the globe</a>.</p>
<p>A <a href="https://www.oie.int/fileadmin/Home/eng/Media_Center/docs/pdf/IACG2019/IACG_final_report_EN.pdf">2019 joint report</a> by the United Nations, World Health Organization and World Organization for Animal Health states that drug-resistant diseases could cause 10 million deaths each year by 2050 and force up to 24 million people into extreme poverty by 2030 <a href="https://www.who.int/news/item/29-04-2019-new-report-calls-for-urgent-action-to-avert-antimicrobial-resistance-crisis">if no action is taken</a>. Superbugs are already able to evade all existing treatments – a 70-year-old woman from Nevada died in 2016 from a bacterial infection <a href="https://www.statnews.com/2017/01/12/nevada-woman-superbug-resistant/">resistant to every available antibiotic in the U.S.</a></p>
<p>I am a <a href="https://scholar.google.com/citations?user=zLwzHqcAAAAJ&hl=en">biochemist and microbiologist</a> who has been researching and teaching about antibiotic development and resistance over the past 20 years. I believe that solving this crisis requires more than just proper antibiotic use by doctors and patients. It also requires mutual investment and collaboration across industries and the government. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/ZvhFeGEDFC8?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Antibiotics revolutionized modern medicine. But improper usage of antibiotics and lack of research funding have led to a growing crisis of antibiotic-resistant bacteria.</span></figcaption>
</figure>
<h2>How do bacteria become resistant to drugs?</h2>
<p>In order to survive, bacteria naturally <a href="https://theconversation.com/we-know-why-bacteria-become-resistant-to-antibiotics-but-how-does-this-actually-happen-59891">evolve to become resistant</a> to the drugs that kill them. They do this via two methods: genetic mutation and horizontal gene transfer.</p>
<p><a href="https://doi.org/10.1111/j.1469-0691.2006.01492.x">Genetic mutation</a> occurs when the bacteria’s DNA, or genetic material, randomly changes. If these changes let the bacteria evade an antibiotic that would have otherwise killed it, it will be able to survive and pass on this resistance when it reproduces. Over time, the proportion of resistant bacteria will increase as nonresistant bacteria are killed by the antibiotic. Eventually, the drug will no longer work on these bacteria because they all have the mutation for resistance.</p>
<p>The other method bacteria use is <a href="https://doi.org/10.1093/emph/eov018">horizontal gene transfer</a>. Here, one bacterium acquires resistance genes from another source, either through their environment or directly from another bacterium or bacterial virus.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/428916/original/file-20211027-25-1jjmhcf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Diagram of bacterial horizontal gene transfer types." src="https://images.theconversation.com/files/428916/original/file-20211027-25-1jjmhcf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/428916/original/file-20211027-25-1jjmhcf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=306&fit=crop&dpr=1 600w, https://images.theconversation.com/files/428916/original/file-20211027-25-1jjmhcf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=306&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/428916/original/file-20211027-25-1jjmhcf.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=306&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/428916/original/file-20211027-25-1jjmhcf.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=384&fit=crop&dpr=1 754w, https://images.theconversation.com/files/428916/original/file-20211027-25-1jjmhcf.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=384&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/428916/original/file-20211027-25-1jjmhcf.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=384&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Bacteria can gain resistance via infection from a virus (transduction), picking it up from the environment (transformation) or direct transfer from other bacteria (conjugation).</span>
<span class="attribution"><a class="source" href="https://commons.wikimedia.org/wiki/File:Bacterial_horizontal_gene_transfer.jpg">2013MMG320B/Wikimedia Commons</a></span>
</figcaption>
</figure>
<p>But the antibiotic resistance crisis is largely <a href="https://doi.org/10.3390/w13192693">anthropogenic, or human-made</a>. Factors include the overuse and abuse of antibiotics, as well as a lack of regulations and enforcement pertaining to proper use. For example, doctors prescribing antibiotics for <a href="https://www.mayoclinic.org/healthy-lifestyle/consumer-health/in-depth/antibiotics/art-20045720">nonbacterial infections</a> and patients not completing their <a href="https://theconversation.com/why-you-really-should-take-your-full-course-of-antibiotics-81704">prescribed course of treatment</a> give bacteria the chance to evolve resistance.</p>
<p>There are also no regulations on <a href="https://dx.doi.org/10.3390%2Fmolecules23040795">antibiotic use in animal agriculture</a>, including controlling leakage into the surrounding environment. <a href="https://www.pewtrusts.org/en/research-and-analysis/articles/2019/10/28/fda-should-expedite-new-rules-on-antibiotic-use-in-food-animals">Only recently</a> has there been a push for more antibiotic oversight in agriculture in the U.S. As an October 2021 report by the National Academies of Sciences, Engineering and Medicine noted, antibiotic resistance is an issue that <a href="https://www.nationalacademies.org/news/2021/10/combating-antimicrobial-resistance-globally-requires-maintaining-safety-of-available-antibiotics-and-a-robust-pipeline-animal-and-environmental-health-strategies-also-needed">connects human, environmental and animal health</a>. Effectively addressing one facet requires addressing the others.</p>
<h2>The antibiotic discovery void</h2>
<p>One of the major reasons for the resistance crisis is the stalling of antibiotic development over the past 34 years. Scientists call this the <a href="https://www.reactgroup.org/toolbox/understand/how-did-we-end-up-here/few-antibiotics-under-development/">antibiotic discovery void</a>. </p>
<p>Researchers discovered the last class of highly effective antibiotics in 1987. Since then, no new antibiotics have made it out of the lab. This is partly because there was <a href="https://doi.org/10.1093/fqsafe/fyz003">no financial incentive</a> for the pharmaceutical industry to invest in further research and development. Antibiotics at the time were also effective at what they did. Unlike chronic diseases like hypertension and diabetes, bacterial infections don’t typically require ongoing treatment, and so have a lower return on investment.</p>
<p><iframe id="49G1P" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/49G1P/2/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<p>Reversing this trend requires investment not just in drug development, but also in the basic research that allows scientists to understand how antibiotics and bacteria work in the first place. </p>
<p><a href="https://www.formpl.us/blog/basic-research">Basic research</a> focuses on advancing knowledge rather than developing interventions to solve a specific problem. It gives scientists the opportunity to ask new questions and think long-term about the natural world. A better understanding of the driving forces behind antibiotic resistance can lead to innovations in drug development and techniques to combat multidrug-resistant bacteria.</p>
<p>Basic science also provides <a href="https://dx.doi.org/10.1210%2Fme.2014-1343">opportunities to mentor the next generation of researchers</a> tasked with solving problems like antibiotic resistance. By teaching students about the fundamental principles of science, basic scientists can train and inspire the future workforce with the passion, aptitude and competency to address problems that require scientific understanding to solve.</p>
<h2>Collaboration by triangulation</h2>
<p>Many scientists agree that addressing antibiotic resistance <a href="https://www.scientificamerican.com/article/how-to-solve-the-problem-of-antibiotic-resistance/">requires more than just responsible use</a> by individuals. The federal government, academia and pharmaceutical companies need to partner together in order to effectively tackle this crisis – what I call collaboration by triangulation.</p>
<p>[<em>The Conversation’s science, health and technology editors pick their favorite stories.</em> <a href="https://theconversation.com/us/newsletters/science-editors-picks-71/?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=science-favorite">Weekly on Wednesdays</a>.]</p>
<p>Collaboration between basic scientists in academia and pharmaceutical companies is one pillar of this effort. While basic science research provides the knowledge foundation to discover new drugs, pharmaceutical companies have the infrastructure to produce them at a scale typically unavailable in academic settings.</p>
<p>The remaining two pillars involve financial and legislative support from the federal government. This includes enhancing research funding for academics and changing current policies and practices that <a href="https://doi.org/10.1093/ofid/ofaa001">impede, rather than offer, incentives</a> for pharmaceutical company investment in antibiotic development.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/428915/original/file-20211027-21-1et43ur.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Antibiotic capsules filling white background." src="https://images.theconversation.com/files/428915/original/file-20211027-21-1et43ur.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/428915/original/file-20211027-21-1et43ur.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/428915/original/file-20211027-21-1et43ur.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/428915/original/file-20211027-21-1et43ur.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/428915/original/file-20211027-21-1et43ur.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/428915/original/file-20211027-21-1et43ur.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/428915/original/file-20211027-21-1et43ur.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Partnership between academia, pharmaceutical companies and the government could help expedite antibiotic development.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/colorful-of-antibiotic-capsules-pills-isolated-on-royalty-free-image/887228372">Fahroni/iStock via Getty Images Plus</a></span>
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</figure>
<p>To that end, a bipartisan bill proposed in June 2021, the <a href="https://www.statnews.com/2021/06/25/pasteur-act-help-fight-superbugs-antimicrobial-resistance/">Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act</a>, aims to fill the discovery void. If passed into law, the bill would pay developers contractually agreed-upon amounts to research and develop antimicrobial drugs for <a href="https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity#howlongpatentterm">a time period</a> that ranges from five years up to the end of the patent.</p>
<p>I believe the passage of this act would be an important step in the right direction to address antibiotic resistance and the threat it poses to human health in the U.S. and around the globe. A monetary incentive to take up basic research around new ways to kill dangerous bacteria seems to me like the world’s best available option for emerging from the antibiotic resistance crisis.</p><img src="https://counter.theconversation.com/content/169443/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Andre Hudson receives funding from the National Institutes of Health. </span></em></p>If no action is taken to address antibiotic resistance, infections from multidrug-resistant bacteria could cause 10 million deaths each year by 2050.André O. Hudson, Professor and Head of the Thomas H. Gosnell School of Life Sciences, Rochester Institute of TechnologyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1649902021-08-31T12:28:57Z2021-08-31T12:28:57ZNew gene therapies may soon treat dozens of rare diseases, but million-dollar price tags will put them out of reach for many<figure><img src="https://images.theconversation.com/files/418515/original/file-20210830-22-1fltn8m.jpg?ixlib=rb-1.1.0&rect=248%2C144%2C8488%2C4217&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Gene therapy uses our genomic makeup to treat or prevent disease. </span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/biotechnology-molecular-engineering-dna-genetic-royalty-free-image/1310024666">ktsimape/iStock via Getty Images</a></span></figcaption></figure><p><a href="https://theconversation.com/the-most-expensive-drug-in-the-world-how-it-works-and-the-devastating-disease-it-treats-164535">Zolgensma</a> – which treats <a href="https://www.mda.org/disease/spinal-muscular-atrophy">spinal muscular atrophy</a>, a rare genetic disease that damages nerve cells, leading to muscle decay – is currently the most expensive drug in the world. A one-time treatment of the life-saving drug for a young child <a href="https://www.npr.org/sections/health-shots/2019/05/24/725404168/at-2-125-million-new-gene-therapy-is-the-most-expensive-drug-ever">costs US$2.1 million</a>.</p>
<p>While Zolgensma’s exorbitant price is an outlier today, by the end of the decade there’ll be dozens of cell and gene therapies, costing hundreds of thousands to millions of dollars for a single dose. The Food and Drug Administration <a href="https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-peter-marks-md-phd-director-center-biologics">predicts that by 2025 it will be approving 10 to 20 cell and gene therapies</a> every year.</p>
<p>I’m a <a href="https://www.kevindoxzen.com/">biotechnology and policy expert</a> focused on improving access to cell and gene therapies. While these forthcoming treatments have the potential to save many lives and ease much suffering, health care systems around the world aren’t equipped to handle them. Creative new payment systems will be necessary to ensure everyone has equal access to these therapies. </p>
<h2>The rise of gene therapies</h2>
<p>Currently, only <a href="https://globalgenes.org/rare-facts/">5% of the roughly 7,000 rare diseases</a> have an FDA-approved drug, leaving thousands of conditions without a cure.</p>
<p>But over the past few years, genetic engineering technology has made <a href="https://www.genengnews.com/insights/the-outlook-for-2020-and-beyond/">impressive strides</a> toward the ultimate goal of curing disease by <a href="https://www.npr.org/sections/health-shots/2019/10/21/771266879/scientists-create-new-more-powerful-technique-to-edit-genes">changing a cell’s genetic instructions</a>.</p>
<p>The resulting <a href="https://theconversation.com/boyer-lectures-gene-therapy-is-still-in-its-infancy-but-the-future-looks-promising-104558">gene therapies</a> will be able to treat many diseases at the DNA level in a single dose. </p>
<p><a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4786935/#:%7E:text=There%20are%205%2C000%E2%80%938%2C000%20monogenic,mutations%20on%20a%20single%20gene.">Thousands of diseases</a> are the result of DNA errors, which prevent cells from functioning normally. By directly correcting disease-causing mutations or altering a cell’s DNA to give the cell new tools to fight disease, <a href="https://theconversation.com/explainer-what-is-gene-therapy-19883">gene therapy</a> offers a powerful new approach to medicine.</p>
<p>There are <a href="https://asgct.org/global/documents/asgct-pharma-intelligence-quarterly-report-july-20.aspx?_zs=sisac&_zl=Uu4h2">1,745 gene therapies</a> in development around the world. A large fraction of this research focuses on rare genetic diseases, which affect <a href="https://globalgenes.org/rare-facts/">400 million people worldwide</a>. </p>
<p>We may soon see cures for rare diseases like <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa2031054">sickle cell disease</a>, <a href="https://www.pnas.org/content/118/22/e2004840117">muscular dystrophy</a> and <a href="https://www.sciencemag.org/news/2021/01/incredible-gene-editing-result-mice-inspires-plans-treat-premature-aging-syndrome">progeria</a>, a rare and progressive genetic disorder that causes children to age rapidly. </p>
<p>Further into the future, gene therapies may help treat more common conditions, like <a href="https://www.nature.com/articles/d41586-018-02482-4">heart disease</a> and <a href="https://www.wsj.com/articles/crisprs-next-frontier-treating-common-conditions-11620226832">chronic pain</a>. </p>
<h2>Sky-high price tags</h2>
<p>The problem is these therapies will carry enormous price tags. </p>
<p>Gene therapies are the result of years of research and development totaling hundreds of millions to <a href="https://fortune.com/2020/02/07/zolgensma-high-drug-prices/">billions of dollars</a>. Sophisticated manufacturing facilities, highly trained personnel and complex biological materials set gene therapies apart from other drugs.</p>
<p>Pharmaceutical companies say recouping costs, especially for drugs with <a href="https://www.technologyreview.com/2017/10/24/148183/tracking-the-cost-of-gene-therapy/">small numbers of potential patients</a>, means higher prices.</p>
<p>The toll of high prices on health care systems will not be trivial. Consider a gene therapy cure for sickle cell disease, which is expected to be available in the next few years. The estimated price of this treatment is $1.85 million per patient. As a result, economists predict that it could cost a single state Medicare program <a href="https://www.doi.org/10.1001/jamapediatrics.2020.7140">almost $30 million per year</a>, even assuming only 7% of the eligible population received the treatment. </p>
<p>And that’s just one drug. Introducing dozens of similar therapies into the market would <a href="https://www.valueinhealthjournal.com/article/S1098-3015(19)30188-3/fulltext">strain health care systems</a> and create <a href="https://www.insurancejournal.com/news/national/2019/09/13/539591.htm">difficult financial decisions for private insurers</a>.</p>
<p>[<em>Over 110,000 readers rely on The Conversation’s newsletter to understand the world.</em> <a href="https://theconversation.com/us/newsletters/the-daily-3?utm_source=TCUS&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=100Ksignup">Sign up today</a>.]</p>
<h2>Lowering costs, finding new ways to pay</h2>
<p>One solution for improving patient access to gene therapies would be to simply demand drugmakers charge less money, a <a href="https://www.statnews.com/2021/04/22/bluebirds-withdrawal-of-therapy-from-germany-could-chill-talks-over-gene-therapy-prices-across-europe/">tactic recently taken in Germany</a>. </p>
<p>But this comes with a lot of challenges and may mean that companies <a href="https://www.fiercepharma.com/pharma/situation-untenable-bluebird-will-wind-down-its-operations-broken-europe">simply refuse to offer the treatment</a> in certain places.</p>
<p>I think a more balanced and sustainable approach is two-fold. In the short term, it’ll be important to develop new payment methods that entice insurance companies to cover high-cost therapies and distribute risks across patients, insurance companies and drugmakers. In the long run, improved gene therapy technology will inevitably help lower costs.</p>
<p>For innovative payment models, one tested approach is tying coverage to patient health outcomes. Since these therapies are still experimental and relatively new, there isn’t much data to help insurers make the risky decision of whether to cover them. If an insurance company is paying $1 million for a therapy, it had better work. </p>
<p>In <a href="https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/unlocking-market-access-for-gene-therapies-in-the-united-states">outcomes-based models</a>, insurers will either pay for some of the therapy upfront and the rest only if the patient improves, or cover the entire cost upfront and receive a reimbursement if the patient doesn’t get better. These models help insurers share financial risk with the drug developers.</p>
<p>Another model is known as the “<a href="https://www.doi.org/10.1377/hblog20190924.559225">Netflix model</a>” and would act as a subscription-based service. Under this model, a state Medicaid program would pay a pharmaceutical company a flat fee for access to unlimited treatments. This would allow a state to <a href="https://www.cnbc.com/2019/05/20/commentary-new-drug-cures-risk-widening-income-gap-for-the-poor.html">provide the treatment to residents who qualify</a>, helping governments balance their budget books while giving drugmakers money upfront. </p>
<p>This model has worked well for <a href="https://www.biopharmadive.com/news/cms-approves-louisianas-netflix-model-with-gilead-for-hepatitis-c-drugs/557708/">improving access to hepatitis C drugs in Louisiana</a>.</p>
<p>On the cost front, the key to improving access will be investing in new technologies that simplify medical procedures. For example, the costly sickle cell gene therapies currently in clinical trials require a series of expensive steps, including a stem cell transplant. </p>
<p>The <a href="https://www.gatesfoundation.org/ideas/articles/gene-therapy-mike-mccune">Bill & Melinda Gates Foundation</a>, the <a href="https://www.nih.gov/news-events/news-releases/nih-launches-new-collaboration-develop-gene-based-cures-sickle-cell-disease-hiv-global-scale">National Institute of Health</a> and <a href="https://www.novartis.com/news/media-releases/novartis-and-bill-melinda-gates-foundation-collaborate-discover-and-develop-accessible-vivo-gene-therapy-sickle-cell-disease">Novartis</a> are partnering to develop an alternative approach that would involve a simple injection of gene therapy molecules. The goal of their collaboration is to help bring an affordable sickle cell treatment to <a href="https://www.statnews.com/2019/10/23/nih-gates-foundation-genetic-cures-hiv-sickle-cell/">patients in Africa</a> and other low-resource settings. </p>
<p>Improving access to gene therapies requires collaboration and compromise across governments, nonprofits, pharmaceutical companies and insurers. Taking proactive steps now to develop innovative payment models and invest in new technologies will help ensure that health care systems are ready to deliver on the promise of gene therapies.</p>
<p><em>The Bill & Melinda Gates Foundation has provided funding for The Conversation US and provides funding for The Conversation internationally.</em></p><img src="https://counter.theconversation.com/content/164990/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Kevin Doxzen is affiliated with Arizona State University and the World Economic Forum</span></em></p>New payment models may mean more of the people who need these treatments can get them.Kevin Doxzen, Hoffmann Postdoctoral Fellow, Arizona State UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1650822021-08-03T20:06:32Z2021-08-03T20:06:32ZCOVID vaccines offer the pharma industry a once-in-a-generation opportunity to reset its reputation. But it’s after decades of big profits and scandals<figure><img src="https://images.theconversation.com/files/414139/original/file-20210802-24-bh8h6h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://unsplash.com/photos/QwFyqPKyyY0">Elsa Olofsson/Unsplash</a></span></figcaption></figure><p>Just weeks before the first COVID-19 cases emerged, Gallup published its <a href="https://news.gallup.com/poll/266060/big-pharma-sinks-bottom-industry-rankings.aspx">latest poll</a> on America’s views about business. At the bottom of the list of 25 sectors was the pharmaceutical industry. Below advertising. Below oil and gas. Below the banks. </p>
<p>The pandemic and the new vaccines have of course <a href="https://theconversation.com/big-pharmas-covid-19-reputation-boost-may-not-last-heres-why-162975">turned that reputation around</a>, but let’s not forget why the pharmaceutical industry’s credibility sank so low. </p>
<p>Or how the industry got so big. One company, Johnson & Johnson, is currently worth around US$450 billion. About the same as the economy of Norway. </p>
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Read more:
<a href="https://theconversation.com/big-pharmas-covid-19-reputation-boost-may-not-last-heres-why-162975">Big Pharma's COVID-19 reputation boost may not last — here’s why</a>
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<h2>The birth of the behemoths</h2>
<p>The idea of the miraculous potion or cure-all dates back at least as far as Greek mythology. The goddess Panacea even gets a mention in the <a href="https://en.wikipedia.org/wiki/Hippocratic_Oath">Hippocratic Oath</a>. </p>
<p>The rise of the modern pharmaceutical industry is more recent, coming through the 19th century. On the eve of the 20th century, the German company Bayer famously launched its early blockbusters, including “Aspirin” and “Heroin.”</p>
<p>Around this time, US drug-makers were arguing for <a href="https://theconversation.com/the-us-drug-industry-used-to-oppose-patents-what-changed-161319">patent protections</a>, or exclusive rights to market a drug for a specific period of time. By the 1950s, they’d won those arguments, and the US soon became the world’s biggest market for medicines. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/the-us-drug-industry-used-to-oppose-patents-what-changed-161319">The US drug industry used to oppose patents – what changed?</a>
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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">
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<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>
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<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>
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<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>
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<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>
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<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">
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<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>
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<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>
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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>
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<hr>
<p>And the guidelines which can be so influential over a doctor’s prescribing decisions are too often <a href="https://bmjopen.bmj.com/content/9/2/e025864">written by medical experts</a> with ties to drug companies. </p>
<p>Central to this marketing effort are these senior medical experts, sometimes called “<a href="https://www.bmj.com/content/336/7658/1402">key opinion leaders</a>”, who claim to be independent yet accept fees for advice, consultancies or “educational” presentations to other doctors. </p>
<figure class="align-center ">
<img alt="Male doctor types at his computer." src="https://images.theconversation.com/files/414248/original/file-20210803-15-rn30tb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/414248/original/file-20210803-15-rn30tb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/414248/original/file-20210803-15-rn30tb.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/414248/original/file-20210803-15-rn30tb.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/414248/original/file-20210803-15-rn30tb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/414248/original/file-20210803-15-rn30tb.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/414248/original/file-20210803-15-rn30tb.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Just one meal at a sponsored educational event can result in a doctor prescribing more of that company’s drugs.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/doctor-typing-on-his-computer-office-142168426">Shutterstock</a></span>
</figcaption>
</figure>
<p>A former top-selling drug company sales representative turned whistleblower put it plainly in a 2008 piece in <a href="https://www.bmj.com/content/336/7658/1402">The BMJ</a>: </p>
<blockquote>
<p>Key opinion leaders were salespeople for us, and we would routinely measure the return on our investment, by tracking prescriptions before and after their presentations. </p>
<p>If that speaker didn’t make the impact the company was looking for, then you wouldn’t invite them back.</p>
</blockquote>
<p>Unhealthy marketing means the latest most expensive pill is too often favoured over older cheaper options, or doing nothing at all, causing much harm and wasting precious resources. </p>
<h2>Corporate crime</h2>
<p>In 2009 came the biggest health-care fraud settlement in history. Pfizer was forced to fork out a <a href="https://web.archive.org/web/20091212121012/http://www.stopmedicarefraud.gov/index.html">US$2.3 billion fine</a> for illegal promotion, false and misleading claims about drug safety, and paying kickbacks to doctors. That included a US$1.2 billion criminal fine, the largest ever in a US criminal prosecution.</p>
<p>One of the whistleblowers in that case happened to be a <a href="https://www.allenandunwin.com/browse/books/academic-professional/health/Sex-Lies--Pharmaceuticals-Ray-Moynihan-9781742370187">member of a special Pfizer sales team</a> promoting Viagra. He revealed doctors were taken to breakfasts, lunches, dinners, Broadway shows, baseball games, golf courses, ski fields, casinos and strip clubs. </p>
<p>In 2013, Johnson & Johnson paid out US$2.2 billion in civil and criminal fines for putting “<a href="https://www.justice.gov/opa/pr/johnson-johnson-pay-more-22-billion-resolve-criminal-and-civil-investigations">profit over patients’ health</a>”. The company had illegally promoted powerful anti-psychotic drugs as behaviour control for the elderly and most vulnerable, overstating benefits and playing down dangerous side effects, including stroke. </p>
<figure class="align-center ">
<img alt="Older man holds pill to his mouth in one hand and a glass of water in the other." src="https://images.theconversation.com/files/414247/original/file-20210803-23-13hydnm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/414247/original/file-20210803-23-13hydnm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/414247/original/file-20210803-23-13hydnm.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/414247/original/file-20210803-23-13hydnm.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/414247/original/file-20210803-23-13hydnm.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/414247/original/file-20210803-23-13hydnm.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/414247/original/file-20210803-23-13hydnm.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Drug companies have faced massive fines for putting profits over health.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/asian-old-man-taking-pill-another-1679120026">Shutterstock</a></span>
</figcaption>
</figure>
<p>Other court documents around the same time exposed how the giant global company Merck used <a href="https://www.bmj.com/content/338/bmj.b1914.extract">dirty tricks</a> to try and defend its controversial anti-arthritis drug Vioxx. Merck created a fake medical journal and drew up secret lists of academic critics to “neutralise” and “discredit”. </p>
<p>In the end, Vioxx was taken off the market because it was causing heart attacks, with estimates in <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(05)17864-7/fulltext">The Lancet</a> suggesting it may have led to 140,000 cases of serious coronary heart disease.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/the-most-powerful-companies-youve-never-heard-of-merck-3187">The most powerful companies you've never heard of: Merck</a>
</strong>
</em>
</p>
<hr>
<h2>Investigation and reform</h2>
<p>Scandals like Vioxx tarnished the industry’s image, and brought more intense scrutiny. </p>
<p>The US National Academy of Sciences produced a <a href="https://www.ncbi.nlm.nih.gov/books/NBK22942/">landmark report</a> arguing the closeness between doctors and drug companies could jeopardise the integrity of science, the objectivity of education, the quality of care, and public trust in medicine. </p>
<p>A series of US congressional hearings on unhealthy marketing produced the <a href="https://openpaymentsdata.cms.gov/">Open Payments</a> register, mandated by US law to publicly list every company payment to every doctor. </p>
<p>Many around the world are <a href="https://www.bmj.com/content/367/bmj.l6576">reforming further</a>, moving from transparency to independence. Italy brought in a <a href="https://pubmed.ncbi.nlm.nih.gov/20055898/">special tax</a> on drug company promotion to fund public interest research. Norway doesn’t give doctors full credit anymore for <a href="https://www.legeforeningen.no/om-oss/Styrende-dokumenter/legeforeningens-lover-og-andre-organisatoriske-regler/avtale-mellom-legemiddelindustriforeningen-og-den-norske-lageforening-om-retningslinjer-for-samarbeid-og-samhandling-mellom-leger-legeforeningen-og-legemiddelindustrien/#23800">industry-sponsored</a> education. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/guidelines-governing-canadian-doctors-relationships-with-pharma-companies-under-review-149519">Guidelines governing Canadian doctors' relationships with pharma companies under review</a>
</strong>
</em>
</p>
<hr>
<p>But there’s a long way to go. A <a href="https://www.bmj.com/content/369/bmj.m1505">study</a> in 2020 found 80% of the medicos who run the world’s most powerful doctors organisations still take money from drug and device companies. For research, for consultancies, for hospitality. </p>
<p>Even some agencies which assess drugs, notably the <a href="https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance">US Food and Drug Administration</a> (FDA), still rely on significant funding from industry, which pays to have its products assessed. </p>
<p>And the harmful marketing has continued. Just last month, a group of drug companies, including Johnson & Johnson, <a href="https://www.theguardian.com/us-news/2021/jul/21/us-opioid-settlement-state-attorneys-general-johnson-and-johnson">agreed to pay</a> a total of US$26 billion for their roles in fuelling the opioid epidemic. </p>
<h2>A prescription for trust</h2>
<p>One drug company chief <a href="https://www.fiercepharma.com/pharma/amid-challenges-a-covid-19-opportunity-for-pharma-a-chance-to-bolster-its-reputation-lilly">reportedly said</a> last year the industry had a “once-in-a-generation opportunity to reset” its reputation. </p>
<p>Given the dark arts that drove pharma’s credibility to rock bottom, its fanciful to imagine the pandemic will magically end the misleading marketing and the price gouging.</p>
<p>Any post-pandemic recovery requires meaningful reform. </p>
<hr>
<p><em>This article is part of a global Conversation series, <a href="https://theconversation.com/au/topics/the-business-of-pharmaceuticals-108206">The business of pharmaceuticals</a>. You can read the other articles <a href="https://theconversation.com/au/topics/the-business-of-pharmaceuticals-108206">here</a>.</em></p><img src="https://counter.theconversation.com/content/165082/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ray Moynihan is Assistant Professor at Bond University's Institute for Evidence-Based Healthcare and Adjunct Associate Professor at the University of Sydney. He receives funding via competitive grants from Australia's publicly funded National Health and Medical Research Council. Ray has written about and researched the pharmaceutical industry's influence for almost 25 years and is the author of 4 books on the business of medicine. </span></em></p>The COVID pandemic is giving drug companies an opportunity to reset their image. So how did they get so big and their credibility sink so low?Ray Moynihan, Assistant Professor, Bond UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1629752021-07-14T12:57:07Z2021-07-14T12:57:07ZBig Pharma’s COVID-19 reputation boost may not last — here’s why<figure><img src="https://images.theconversation.com/files/411053/original/file-20210713-23-q0rjjq.JPG?ixlib=rb-1.1.0&rect=0%2C56%2C4165%2C2687&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The first Pfizer-BioNTech COVID-19 vaccine dose in Canada sits ready for use at The Michener Institute in Toronto in mid-December 2020, less than a year from when the World Health Organization declared COVID-19 a pandemic.</span> <span class="attribution"><span class="source">THE CANADIAN PRESS/Frank Gunn </span></span></figcaption></figure><p>The race for developing effective COVID-19 vaccines has <a href="https://fortune.com/longform/covid-vaccine-big-pharma-drugmakers-coronavirus-pharmaceutical-industry/">put the pharmaceutical industry in the spotlight</a>. </p>
<p>Over the past few months, the world has witnessed rapid clinical trials and approvals of several highly effective vaccines like Pfizer, Moderna and AstraZeneca. This unprecedented achievement has been made possible by <a href="https://doi.org/10.1038/s41587-021-00912-9">close intra-industry, state industry and international collaborations</a>. </p>
<p>Big Pharma’s proactive approach to vaccine development has also brought an unexpected consequence: its reputation has been notably enhanced since early 2020. A survey conducted in February 2021 found that <a href="https://www.fiercepharma.com/marketing/pharma-reputation-hits-high-americans-two-thirds-now-give-positive-rating-harris-poll">almost two-thirds of Americans now give the pharmaceutical industry high marks</a>.</p>
<p><a href="https://www.ft.com/content/7ad9d74e-f4e7-4b30-9391-0b934662b6ac">But reputation risks loom</a> even as pharma companies are being celebrated as pandemic heroes. </p>
<p>The controversy over the AstraZeneca vaccine’s potential serious side-effects is a prime example. The English company has experienced a public backlash <a href="https://www.theguardian.com/business/2021/mar/26/how-the-astrazeneca-vaccine-became-a-political-football-and-a-pr-disaster">due to a lack of a crisis response plan and conflicting messages delivered by different stakeholders</a>. </p>
<figure class="align-center ">
<img alt="AstraZeneca sign on the side of a building." src="https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=329&fit=crop&dpr=1 600w, https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=329&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=329&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=414&fit=crop&dpr=1 754w, https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=414&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/411054/original/file-20210713-15-37yx3u.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=414&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">The global headquarters of AstraZeneca in London.</span>
<span class="attribution"><span class="source">(AP Photo/Kirsty Wigglesworth)</span></span>
</figcaption>
</figure>
<p>Will the reputation boost enable the pharmaceutical industry to fundamentally rebuild its negative public image? As someone who researches public relations, I believe that only by prioritizing socially responsible practices can Big Pharma achieve true reputation redemption. </p>
<h2>Big Pharma’s damaged reputation</h2>
<p>Prior to the COVID-19 pandemic, the pharmaceutical industry had been battling reputational damage for years. Notably, <a href="https://news.gallup.com/poll/266060/big-pharma-sinks-bottom-industry-rankings.aspx">it sank to the bottom of Gallup’s August 2019 United States industry favourability poll</a>, with a total positive score of only 27 per cent. According to Gallup’s analysis, high drug costs, massive advertising and lobbying spending and the opioid crisis have all tarnished the industry’s public image. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/oxycontin-how-purdue-pharma-helped-spark-the-opioid-epidemic-57331">Oxycontin: how Purdue Pharma helped spark the opioid epidemic</a>
</strong>
</em>
</p>
<hr>
<p>This is consistent with public relations research conducted in Europe. In <a href="https://doi.org/10.1177/2046147X18774588">a qualitative analysis published by <em>Public Relations Inquiry</em></a>, a team of Ghent University researchers analyzed how Belgian pharma companies responded to the pervasive “Bad Pharma” public image. </p>
<p>Their analysis revealed that Bad Pharma perceptions reflected larger societal issues, including widening income and health gaps. The public expects the pharmaceutical industry to save and improve lives by developing innovative, affordable and effective medicines. Accordingly, the industry loses trust when the public believes its actions and motives are at odds with those expectations. Such a decline in public trust can’t be easily fixed by corporate responsibility reports or public relations campaigns.</p>
<p>The pharmaceutical industry’s reputational challenges also correlate to how the media covers it. A <a href="https://doi.org/10.1007/s43441-019-00048-8">2020 analysis of Big Pharma-related coverage</a> found that the majority of stories were neutral and involved reporting on topics like finances, stocks, profits, mergers, acquisitions and restructuring. Coverage is more negative when it delves, less often, into more sentimental topics. </p>
<p>In other words, the media mostly reports on Big Pharma from a business perspective instead of from a social and public health perspective. This lack of media attention to the industry’s social responsibilities contributes to growing public distrust of it in recent years.</p>
<figure class="align-center ">
<img alt="A man holds a sign that reads Drug Users Deserve Health Care with Heart." src="https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=397&fit=crop&dpr=1 600w, https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=397&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=397&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=498&fit=crop&dpr=1 754w, https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=498&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/411056/original/file-20210713-25-5pdfbs.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=498&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A man holds a sign in Vancouver in 2017 during a march on the first National Day of Action to draw attention to the opioid overdose epidemic.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Darryl Dyck</span></span>
</figcaption>
</figure>
<h2>Risks underlie vaccine-led reputation boost</h2>
<p>Considering the above factors, it’s unsurprising that the pharmaceutical industry’s all-hands-on-deck efforts on COVID-19 vaccines, in combination with extensive media coverage, has resulted in <a href="https://www.vox.com/policy-and-politics/2021/4/2/22362078/covid-19-vaccines-pfizer-pharma-companies-popularity">a substantial improvement in public sentiment</a>. According to <a href="https://www.filesforprogress.org/datasets/2021/3/dfp-pharma-infrastructure-funding.pdf">a survey conducted by think tank Data for Progress in March 2021</a>, 56 per cent of respondents had a favourable view of pharmaceutical companies, double the rating of Gallup’s 2019 poll. </p>
<p>Nonetheless, a closer look at the data reveals two caveats. </p>
<p>First, drug costs remain the top concern for the public. The Data for Progress survey suggests that 72 per cent of American voters support policy measures that would lower the cost of prescription drugs. The pharma industry, meantime, insists that the discounted prices it’s currently offering for COVID-19 vaccines will not last very long. </p>
<h2>Vaccine prices to rise?</h2>
<p>In February, Pfizer CFO Frank D'Amelio said in <a href="https://www.biopharmadive.com/news/coronavirus-vaccines-pricing-questions-moderna-pfizer/594762/">a call with Wall Street analysts</a> that after the pandemic, Pfizer is “going to get more on price” and hinted there would be a substantial price increase for its COVID-19 vaccine. </p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Two men sit in front of a Pfizer sign." src="https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=410&fit=crop&dpr=1 600w, https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=410&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=410&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=516&fit=crop&dpr=1 754w, https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=516&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/411057/original/file-20210713-17-5dcfkv.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=516&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Pfizer Canada executives hold a news conference in Montréal in 2012.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Graham Hughes</span></span>
</figcaption>
</figure>
<p>The company currently charges US$19.50 per dose for its vaccine, but the typical price is $150 to $175 per dose for other vaccines it sells. If implemented, this aggressive pricing policy would undoubtedly result in public criticism, especially from developing countries that have already been neglected during the first round of global vaccine allocation.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/global-herd-immunity-remains-out-of-reach-because-of-inequitable-vaccine-distribution-99-of-people-in-poor-countries-are-unvaccinated-162040">Global herd immunity remains out of reach because of inequitable vaccine distribution – 99% of people in poor countries are unvaccinated</a>
</strong>
</em>
</p>
<hr>
<p>Second, the remarkable speed of research and innovation achieved during COVID-19 vaccine development is mainly due to intensive government funding support and concerted collaborations across multiple sectors. It’s uncertain whether these special measures herald the arrival of a new model in which governments have better regulation over Big Pharma issues like patent control, advertising, clinical data transparency and spending on lobbying.</p>
<p>If the pharmaceutical industry wants to achieve the ultimate image makeover, it must capitalize on the current goodwill by prioritizing socially responsible practices. That begins with fairer drug pricing and a genuine commitment to resolving public health disparities.</p><img src="https://counter.theconversation.com/content/162975/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Sibo Chen receives funding from Ryerson University and the Social Sciences and Humanities Research Council of Canada. </span></em></p>If Big Pharma wants to achieve the ultimate image makeover, it must capitalize on the current public good will about its COVID-19 vaccines by prioritizing socially responsible practices.Sibo Chen, Assistant Professor, School of Professional Communication, Toronto Metropolitan UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1628982021-06-23T12:25:30Z2021-06-23T12:25:30ZThe FDA’s weak drug manufacturing oversight is a potentially deadly problem<figure><img src="https://images.theconversation.com/files/407536/original/file-20210621-30-1wquz93.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C5607%2C3732&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Though drug recalls are relatively uncommon in the U.S., reduced inspections increase the likelihood of manufacturing errors that slip through the cracks.</span> <span class="attribution"><a class="source" href="https://newsroom.ap.org/detail/IndiaGenericDrugs/9d0fb82a0ea441ea9eecbcc8cea2d032/">AP Photo/Rafiq Maqbool</a></span></figcaption></figure><p>The <a href="https://theconversation.com/restart-of-the-johnson-and-johnson-covid-19-vaccine-a-doctor-explains-why-benefits-far-outweigh-risks-159314">latest setback</a> for Johnson & Johnson’s COVID-19 vaccine was the U.S. Food and Drug Administration’s order on June 11, 2021, to <a href="https://www.nytimes.com/2021/06/11/us/politics/johnson-covid-vaccine-emergent.html">discard 60 million doses</a> that failed to meet quality and safety guidelines. A Baltimore manufacturing facility run by Emergent BioSolutions had been producing COVID-19 vaccines for both J&J and AstraZeneca and inadvertently mixed up ingredients from the two companies.</p>
<p>The FDA regularly inspects manufacturing facilities to ensure that drugs meet <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references">rigorous quality standards</a>. These standards are vital to protect patients from drugs that are incorrectly dosed, contaminated or ineffective.</p>
<p>But over the past few years, tens of millions of doses of <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts">prescription and over-the-counter drugs</a> have failed FDA quality expectations. This includes the ongoing 2018 recall of thousands of batches of <a href="https://doi.org/10.1177/1060028019892222">popular blood pressure, diabetes and acid reflux medications</a> containing the probable carcinogen <a href="https://dx.doi.org/10.1634%2Ftheoncologist.2020-0142">NDMA</a>.</p>
<p>For perspective, the number of individual tablets and capsules for prescription and over-the-counter drugs entering the U.S. each year is <a href="https://www.fda.gov/news-events/congressional-testimony/securing-us-drug-supply-chain-oversight-fdas-foreign-inspection-program-12102019">counted in the trillions</a>.</p>
<p>Manufacturers may still backslide while the pandemic continues to put inspections on the back burner. As a <a href="https://scholar.google.com/citations?user=lWAD9d8AAAAJ&hl=en">pharmacist</a> and <a href="https://scholar.google.com/citations?user=Yw89miMAAAAJ&hl=en">physician</a> team investigating <a href="https://doi.org/10.1177/10600280211022281">drug</a>, <a href="https://doi.org/10.1111/j.1542-474x.2006.00098.x">device</a> and <a href="https://doi.org/10.1177/10600280211023328">dietary supplement</a> safety, we are concerned about the current level of manufacturing oversight in the U.S. and overseas. To protect consumers, the FDA needs to strike a balance between quickly getting lifesaving drugs out to market and rigorously ensuring their safety.</p>
<h2>FDA’s overseas oversight fell under the radar</h2>
<p>Over the past 30 years, U.S. pharmaceutical companies have laid off <a href="http://www.pharmatimes.com/news/pfizer_looks_to_asia_and_will_outsource_30_of_manufacturing_991514">tens of thousands of U.S. manufacturing workers</a> and moved their drug manufacturing overseas. The main reasons for this <a href="https://www.npr.org/sections/health-shots/2020/04/24/843379899/pandemic-underscores-u-s-dependence-on-overseas-factories-for-medicines">outsourcing</a> include cheaper labor, looser environmental regulations and less oversight. Meanwhile, pharmaceutical companies in India and China captured a <a href="https://cen.acs.org/business/outsourcing/Bringing-drug-production-back-US/98/i25">greater share</a> of the U.S. generic drug market. As of May 2020, 74% of facilities manufacturing active ingredients and 54% manufacturing finished drugs for the U.S. were <a href="https://www.gao.gov/assets/gao-21-409t.pdf">located overseas</a>.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/407541/original/file-20210621-26003-132mjwp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Person picking up a glass vial among many on a conveyor belt." src="https://images.theconversation.com/files/407541/original/file-20210621-26003-132mjwp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/407541/original/file-20210621-26003-132mjwp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/407541/original/file-20210621-26003-132mjwp.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/407541/original/file-20210621-26003-132mjwp.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/407541/original/file-20210621-26003-132mjwp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/407541/original/file-20210621-26003-132mjwp.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/407541/original/file-20210621-26003-132mjwp.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">Outsourcing of drug manufacturing unevenly split FDA inspections between domestic and foreign facilities.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/biologics-laboratory-royalty-free-image/1189160521">Mikael Sjoberg/Bloomberg Creative Photos via Getty Images</a></span>
</figcaption>
</figure>
<p>Until 2007, the FDA focused almost entirely on inspecting U.S.-based manufacturing plants for drug quality. <a href="https://www.fda.gov/news-events/congressional-testimony/securing-us-drug-supply-chain-oversight-fdas-foreign-inspection-program-12102019">Foreign plants</a>, on the other hand, were on the honor system: The FDA trusted their own internally generated paperwork as proof of compliance. </p>
<p>The folly of this system came to light in 2004, when a <a href="https://fortune.com/2013/05/15/dirty-medicine/">whistleblower alerted the FDA</a> that Ranbaxy Corp., one of the largest generic drug companies in the world, was fabricating its drug test reports. Ranbaxy ultimately paid a <a href="https://www.justice.gov/opa/pr/generic-drug-manufacturer-ranbaxy-pleads-guilty-and-agrees-pay-500-million-resolve-false">US$500 million fine</a> in 2013 for knowingly producing <a href="https://doi.org/10.1177/1060028019881692">substandard drugs for the U.S. market</a> since their <a href="https://www.pharmacytimes.com/view/ranbaxy-ranbaxy-continues-to-add-value-and-utility-to-us-product-portfolio">first FDA approval in 1998</a>.</p>
<h2>The drug inspection overhaul of 2007 to 2019</h2>
<p>After the Ranbaxy fiasco, the FDA increased foreign manufacturing inspections from <a href="https://www.gao.gov/assets/gao-17-143.pdf">333 in 2007</a> to <a href="https://www.fda.gov/news-events/congressional-testimony/securing-us-drug-supply-chain-oversight-fdas-foreign-inspection-program-12102019">966 in 2019</a>. The proportion of foreign manufacturing plants that had never had an FDA inspection <a href="https://www.fda.gov/news-events/congressional-testimony/securing-us-drug-supply-chain-oversight-fdas-foreign-inspection-program-12102019">shrank from 64% in 2010 to 16% in 2019</a>. Of those, the FDA also found that <a href="https://www.fda.gov/news-events/congressional-testimony/securing-us-drug-supply-chain-oversight-fdas-foreign-inspection-program-12102019">37% did not need inspection</a> because they either went out of business, were no longer supplying drugs to the U.S. or were not selling drugs to the U.S. in the first place.</p>
<p><iframe id="98jDL" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/98jDL/2/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<p>As inspections increased, so did the number of serious drug safety issues that came to light. <a href="https://doi.org/10.1177/1060028019881692">Dozens of Indian manufacturing facilities</a> were barred from shipping drugs to the U.S. after the FDA discovered they were manipulating and omitting quality test results and had unsanitary production conditions. Similar findings resulted from inspections of Chinese manufacturing facilities, including the company behind numerous <a href="https://doi.org/10.1177/1060028019892222">blood pressure drug recalls in 2019</a>.</p>
<h2>Decreasing oversight at US manufacturing facilities</h2>
<p>One reason the FDA had less oversight of overseas facilities was limited funding. Before the 2012 <a href="https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments">Generic Drug User Fee Amendment</a>, the FDA was primarily funded by <a href="https://theconversation.com/why-is-the-fda-funded-in-part-by-the-companies-it-regulates-160444">user fees</a> from pharmaceutical, vaccine and medical device manufacturers. The amendment imposed a <a href="https://www.federalregister.gov/documents/2020/08/03/2020-16687/generic-drug-user-fee-rates-for-fiscal-year-2021">$15,000 surcharge</a> on each foreign manufacturing facility to cover the added expense of conducting on-site inspections overseas.</p>
<p>Despite increased inspection funding, the FDA remained stymied by an <a href="https://www.gao.gov/assets/gao-21-409t.pdf">inability to fill job vacancies</a> for both U.S.- and overseas-based inspectors. These vacancies are especially prevalent in India and China, where <a href="https://www.gao.gov/assets/gao-20-262t.pdf">33% and 30% of available overseas-based inspector jobs</a> respectively remained unfilled as of most recent data available November 2019.</p>
<p>The 2012 <a href="https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/food-and-drug-administration-safety-and-innovation-act-fdasia">FDA Safety and Innovation Act</a> removed the legal requirement to inspect U.S. manufacturing facilities every two years. This was partly so the FDA could shift its domestic workforce to foreign inspections, and ensure that all facilities worldwide met the same target criteria. Domestic inspections subsequently <a href="https://www.fda.gov/news-events/congressional-testimony/securing-us-drug-supply-chain-oversight-fdas-foreign-inspection-program-12102019">decreased from 1,122 in 2007 to just 698 in 2019</a>. Currently, the FDA inspects foreign and domestic manufacturing facilities <a href="https://www.gao.gov/assets/gao-21-409t.pdf">every five years</a>, or more frequently when serious issues are identified.</p>
<p><iframe id="e7J23" class="tc-infographic-datawrapper" src="https://datawrapper.dwcdn.net/e7J23/2/" height="400px" width="100%" style="border: none" frameborder="0"></iframe></p>
<p>While the decrease in domestic inspections may have given the FDA more bandwidth for foreign oversight, this may have also pressured FDA officials to gloss over quality issues. </p>
<p>For example, the U.S. Office of Special Counsel discovered in March 2021 that FDA administrators had <a href="https://osc.gov/Documents/Public%20Files/FY21/DI-19-0931/DI-19-0931%20Letter%20to%20the%20President_Redacted.pdf">downplayed whistleblower concerns</a> about serious quality issues in U.S. vaccine manufacturing facilities from 2017 to 2018.</p>
<p>Similarly, a <a href="https://www.fiercepharma.com/manufacturing/some-j-j-covid-19-doses-now-cleared-from-emergent-but-several-countries-are-already">2020 FDA inspection</a> had already identified numerous facility and manufacturing issues in Emergent BioSolution’s Baltimore facility. Had these findings been immediately addressed, cross-contamination with the Johnson & Johnson COVID-19 vaccine would have been less likely. But none of these issues was deemed serious enough to halt production. They were instead allowed to be gradually resolved as production continued.</p>
<h2>How has COVID-19 affected foreign inspections?</h2>
<p>The gap between foreign and domestic inspections has widened over the course of the COVID-19 pandemic. Because international travel shut down <a href="https://www.gao.gov/assets/gao-21-409t.pdf">after March 2020</a>, the FDA conducted only three overseas inspections, and 52 in the U.S.</p>
<p>The effects of the pandemic on inspections may be long-lasting. As of 2020, <a href="https://www.gao.gov/assets/gao-21-409t.pdf">13% of foreign manufacturers</a> have never had an inspection since doing business with the U.S. Another 17% have not been inspected for over five years. With current staffing levels, it will likely take a long time to remedy the backlog.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/407556/original/file-20210621-26-i66xfg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Person in PPE holds a white pill up in front of their eye." src="https://images.theconversation.com/files/407556/original/file-20210621-26-i66xfg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/407556/original/file-20210621-26-i66xfg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=380&fit=crop&dpr=1 600w, https://images.theconversation.com/files/407556/original/file-20210621-26-i66xfg.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=380&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/407556/original/file-20210621-26-i66xfg.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=380&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/407556/original/file-20210621-26-i66xfg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=478&fit=crop&dpr=1 754w, https://images.theconversation.com/files/407556/original/file-20210621-26-i66xfg.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=478&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/407556/original/file-20210621-26-i66xfg.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=478&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Persistent job vacancies may have stretched FDA inspectors thin.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/workers-oversees-the-process-of-granulation-of-pills-and-news-photo/1228923358">Stanislav Krasilnikov/TASS via Getty Images</a></span>
</figcaption>
</figure>
<h2>What does it all mean for consumers?</h2>
<p>Until the FDA has sufficient personnel to conduct rigorous on-site inspections, consumers don’t have many options. Because many states allow or <a href="https://www.fda.gov/media/89135/download">mandate automatic substitution of products the FDA deems bioequivalent</a>, consumers have limited ability to specify which manufacturer’s version they would like to receive at the pharmacy counter.</p>
<p>U.S. consumers can have much more confidence that the drug products they receive today are of higher quality than those from the early 2000s. But the loss of tens of millions of COVID-19 vaccine doses due to poor manufacturing oversight underscores the value of prospective inspections and the risks that reducing domestic inspections pose.</p>
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<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>COVID-19 has exacerbated a backlog of domestic and foreign drug manufacturing inspections that the FDA is still too short-staffed to adequately deal with.Adrian V. Hernandez, Associate Professor of Comparative Effectiveness and Outcomes Research, University of ConnecticutC. Michael White, Distinguished Professor and Head of the Department of Pharmacy Practice, University of ConnecticutLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1608022021-05-12T14:56:17Z2021-05-12T14:56:17ZPush for COVID-19 vaccine patent waiver isn’t a panacea: but it could nudge companies to share<figure><img src="https://images.theconversation.com/files/400295/original/file-20210512-19-32xcql.jpg?ixlib=rb-1.1.0&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>A new proposal, this time from the US, on how to open up access to vaccines against COVID-19 by relaxing patent rights, has added to an already complex and fraught debate between the World Trade Organisation’s 164 members. </p>
<p>In early May, the US took the world by surprise when it <a href="https://ustr.gov/about-us/policy-offices/press-office/press-releases/2021/may/statement-ambassador-katherine-tai-covid-19-trips-waiver">announced</a> that Washington supported an exemption from the World Trade Organisation intellectual property (IP) rules protecting vaccines. The waiver would allow each state to authorise the production of patented vaccines without the consent of the pharmaceutical companies holding the patent.</p>
<p>South Africa and India originally proposed an <a href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32581-2/fulltext">exemption</a> in October 2020. It was opposed by the US (initially), the EU, Switzerland, the UK and Japan. Such a waiver would be optional (countries could opt out) and suspend specific IP rights protected by the WTO <a href="https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm">TRIPS Agreement</a>. </p>
<p>This exemption plan is supported by more than 100 countries. It would allow states to bypass the monopoly of IP holders by authorising the production of cheaper generic drugs and other anti-COVID technologies. The waiver would be temporary, until the majority of the world’s population developed immunity.</p>
<p>The US-supported exemption is slightly different. It covers vaccines only, maintaining IP protection on other products such as diagnostics, treatments, ventilators, respirators, syringes and refrigerators maintaining low temperatures during storage and transport of doses.</p>
<p>But would the WTO waiver be enough? </p>
<p>We believe there are arguments against the waiver. These include the fact that other factors would still stand in the way of easy and quick access to COVID-19 medicines for all countries. But we also argue that the campaign to have a waiver agreed at the WTO could have beneficial outcomes, such as pushing pharmaceutical companies which hold important IP to share it voluntarily.</p>
<h2>The cons</h2>
<p>One <a href="https://www.cato.org/free-trade-bulletin/unnecessary-proposal-wto-waiver-intellectual-property-rights-covid-19-vaccines#does-novel-virus-present-novel-issues">argument</a> against the waiver is that it is unnecessary. </p>
<p>The TRIPS already allows flexibilities. Countries seeking access to medicines can grant compulsory licences (that is, without the IP holder’s consent) under certain conditions. Some have done so during the pandemic. </p>
<p>In March 2020 Israel <a href="https://www.keionline.org/32503">issued</a> one, speeding up the production and sale of Kaletra as an anti-COVID treatment. The US-based pharmaceutical company AbbVie holds the patent.</p>
<p>And the Indian generic manufacturer Natco recently <a href="https://spicyip.com/2021/05/natco-files-compulsory-licence-application-for-covid-drug-baricitinib.html">applied</a> for a licence to produce Baricitinib. This is a rheumatoid arthritis drug that can also treat coronavirus. The IP is held by the US pharmacuetical company Eli Lilly.</p>
<p>States that lack production capacity can, meeting additional conditions, license production abroad with a view to importing the drugs. On 10 May, Bolivia <a href="https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=s:/IP/N/9BOL1.pdf&Open=True">notified</a> a <a href="https://healthpolicy-watch.news/company-pushes-canada-to-grant-compulsory-license-for-johnson-johnson-covid-19-vaccine/">licence</a> to the WTO, for 15 million doses of Johnson & Johnson vaccine produced by the Canadian company Biolyse.</p>
<p>However, compulsory licences must meet a host of requirements. These include the payment of <a href="https://www.mondaq.com/india/patent/616430/fair-remuneration-for-compulsory-licensing">fair compensation</a> to the patent holder. </p>
<p>The waiver proposed by South Africa and India would instead allow countries to circumvent these requirements, insulating generic manufacturers of anti-COVID drugs and technologies from lawsuits.</p>
<p>Another <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3789820">argument</a> undermining the waiver is that it cannot benefit generic producers (and patients), because it would not address the lack of production capacity and poor healthcare systems of many countries. Moreover, it could not alleviate the shortage in raw materials and the steep learning curve of manufacturing processes.</p>
<p>Take the Pfizer <a href="https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html">mRNA</a> vaccines. This technology was developed recently and with revolutionary know-how: no pharmaceutical company can replicate it quickly. The bottleneck is not just IP protection, but the underlying processes around the protected technology. </p>
<p>If a TRIPS waiver passes, Pfizer could lawfully engage in being obstructive by, for example, refusing to disclose its know-how. It would be difficult, if not impossible, to require pharmaceutical companies to reveal that secret, also <a href="https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3843327">because</a> even if such companies were dragged into courts judges would not know which information should be disclosed.</p>
<p>Patents can be suspended by law, but confidential information kept by pharmaceutical companies is not easily retrievable. This has become clear in Bolivia’s plan to import Canadian-made generics. The Canadian manufacturer admitted that “<a href="https://www.reuters.com/world/americas/bolivia-signs-jj-vaccine-deal-with-twist-someone-else-would-make-it-2021-05-11/">if Johnson & Johnson agree to hand over the formula</a>” production could start in less than half the time. </p>
<h2>The pros</h2>
<p>Waiving or relaxing IP rights over anti-COVID technologies cannot fix the global pandemic alone. Nevertheless it could remove some roadblocks. </p>
<p>Arguably, the waiver could push pharma companies holding patents to increase the supply of their drugs. For example, the recent Natco application for a compulsory licence over Baricitinib has prompted Eli Lilly, the patent holder, to grant royalty-free and non-exclusive <a href="https://www.business-standard.com/article/companies/eli-lilly-signs-licensing-pact-with-cipla-sun-lupin-for-covid-19-drug-121051100039_1.html">voluntary licences</a> to Indian generic manufacturers Sun, Cipla and Lupin. Eli Lilly is also negotiating licences with other Indian producers.</p>
<p>So, flexing the muscles via granting compulsory licences sometimes seems to pay off in terms of encouraging patent owners to share their technology. This happened at the beginning of the pandemic. After Israel issued the compulsory licence over the Kaletra drug early last year, the patentee AbbVie voluntarily <a href="https://www.statnews.com/pharmalot/2020/03/20/abbvie-israel-hiv-kaletra-coronavirus-covid19/">dropped</a> its patent rights.</p>
<p>Waiver talks might produce a similar effect: convincing companies to focus on technology transfer and training, perhaps at a profit, and letting go of the plan to maximise patent-based revenues.</p>
<p>It could also be argued that a waiver would be a fair move to make given that over US$12 billion of <a href="https://www.reuters.com/world/americas/bolivia-signs-jj-vaccine-deal-with-twist-someone-else-would-make-it-2021-05-11/">public funding</a> has gone into the research and development of vaccines.</p>
<h2>A compromise in sight?</h2>
<p>It is still not clear what kind of a waiver WTO members can agree – if any. Negotiations might produce a softer solution than proposed by South Africa and India: perhaps a very short exemption with limited coverage, for example only vaccines, as proposed by the US.</p>
<p>Such compromise could neutralise the <a href="https://www.ft.com/content/f54bf71b-87be-4290-9c95-4d110eec7a90">refrain</a> of big pharmaceutical companies against any unwelcome relaxation of IP rights. A limited and short suspension of proprietary rights over COVID vaccines would have a lesser impact on innovation incentives.</p>
<p>A game changer in the fight against COVID could be last week’s WHO <a href="https://www.ft.com/content/7220cbdd-4b8c-49f1-9cf7-5146a691adb6">approval</a> of the vaccine produced by the China-owned company Sinopharm and the Beijing Institute of Biological Products. This is the first vaccine developed by a non-Western country to obtain the WHO green light.</p>
<p>This vaccine can be stored in a standard refrigerator, and “easy storage requirements” – the WHO <a href="https://www.who.int/news/item/07-05-2021-who-lists-additional-covid-19-vaccine-for-emergency-use-and-issues-interim-policy-recommendations">pointed out</a> – make it particularly suitable for developing and least-developed countries. </p>
<p>In addition, there’s a strong likelihood that China could produce enough vaccines to meet its own needs, and still have surplus that it can export. One <a href="https://www.nytimes.com/2021/05/07/business/economy/china-sinopharm-vaccine-who.html">estimate</a> is that the Sinopharm vaccine could be supplied to more than 80 countries. </p>
<p>This would benefit people in states which have not been able to access sufficient vaccines and that have recently been hit hard by COVID. These include India, Brazil, Indonesia and the Philippines.</p>
<p>Strengthening the global supply of vaccines would provide a major boost to efforts to contain COVID-19. Running in parallel with efforts to ease IP rules could see the balance shifted towards containment.</p><img src="https://counter.theconversation.com/content/160802/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>Waiver talks might convince companies to focus on technology transfer and training, and let go of the plan to maximise patent-based revenues.Enrico Bonadio, Reader in Intellectual Property Law, City, University of LondonFilippo Fontanelli, Senior Lecturer in International Economic Law, The University of EdinburghLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1606852021-05-11T21:22:54Z2021-05-11T21:22:54ZCanada is virtue signalling while waffling on global access to COVID-19 vaccines<figure><img src="https://images.theconversation.com/files/400122/original/file-20210511-13-1tuqssl.jpg?ixlib=rb-1.1.0&rect=237%2C26%2C3233%2C2365&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Anita Anand, Canada's minister of public services and procurement, opens a box with some of the first 500,000 of the two million AstraZeneca COVID-19 vaccine doses that Canada secured last March through a deal with the Serum Institute of India. </span> <span class="attribution"><span class="source">THE CANADIAN PRESS/Carlos Osorio - POOL</span></span></figcaption></figure><p>Based on public statements, it’s easy to come to the conclusion that Canada is working to improve global access to COVID-19 vaccines.</p>
<p>This quote comes from an <a href="https://www.washingtonpost.com/opinions/2020/07/15/international-community-must-guarantee-equal-global-access-covid-19-vaccine/">opinion piece</a> in the <em>Washington Post</em> on July 15, 2020; the lead author, none other than Prime Minister Justin Trudeau:</p>
<blockquote>
<p>“…we must urgently ensure that vaccines will be distributed according to a set of transparent, equitable and scientifically sound principles. Where you live should not determine whether you live, and global solidarity is central to saving lives and protecting the economy.”</p>
</blockquote>
<p>The person being quoted here in early May of this year is <a href="https://www.theglobeandmail.com/politics/article-trudeau-wont-state-position-on-covid-19-vaccine-patent-waiver-as/">Mary Ng</a>, the International Trade Minister in Trudeau’s cabinet:</p>
<blockquote>
<p>“The work we have been doing and the leadership we have been providing is very much about removing all barriers to vaccine access, whether it be production or supply chain or export restrictions…We’re trying to remove all barriers to access to vaccines.”</p>
</blockquote>
<p>But despite what Trudeau and Ng said, Canada is not doing all that it can to improve access. Far from it.</p>
<h2>Virtue signalling with little action</h2>
<p>Canada has <a href="https://www.bnnbloomberg.ca/canada-has-reserved-more-vaccine-doses-per-person-than-anywhere-1.1533041">signed contracts for enough vaccine doses</a> to inoculate every woman, man and child in Canada four times. Canada is <a href="https://globalnews.ca/news/7777450/biden-covid-vaccine-canada-help/">accepting vaccine donations</a> from the United States and also <a href="https://www.cbc.ca/news/politics/covax-first-shipment-canada-1.5979777">purchasing vaccines from COVAX</a> (COVID-19 Vaccines Global Access — a mechanism mainly designed to ensure that low- and middle-income countries can access vaccines). </p>
<p>Over one-third of Canadians have <a href="https://health-infobase.canada.ca/covid-19/vaccination-coverage/">received at least one dose of vaccine</a> as of May 7, compared to <a href="https://www.dw.com/en/coronavirus-africas-vaccination-rollout-off-to-slow-start/a-57242006">vaccination rates of under two per cent in Africa</a>. Back in January, Canada <a href="https://www.theglobeandmail.com/world/article-canada-rejects-who-request-for-immediate-vaccine-donations-to-lower/">refused to donate any vaccines</a> and that position has not changed since.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/400123/original/file-20210511-13-1wx018t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A person in a reflective vest and a face mask examining a crate with a COVAX label" src="https://images.theconversation.com/files/400123/original/file-20210511-13-1wx018t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/400123/original/file-20210511-13-1wx018t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/400123/original/file-20210511-13-1wx018t.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/400123/original/file-20210511-13-1wx018t.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/400123/original/file-20210511-13-1wx018t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/400123/original/file-20210511-13-1wx018t.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/400123/original/file-20210511-13-1wx018t.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">A shipment of COVID-19 vaccines distributed by the COVAX Facility arrives in Abidjan, Ivory Coast, last February.</span>
<span class="attribution"><span class="source">(AP Photo/ Diomande Ble Blonde)</span></span>
</figcaption>
</figure>
<p>This pattern of virtue signalling about access to medicines and then doing nothing has a long tradition in Canada.</p>
<p>Back in the late 1990s, the South African government was trying to improve access to drug treatment for the staggering <a href="https://academic.oup.com/ije/article/31/1/37/655915">22 per cent of the population that was HIV positive</a>. At that time, triple therapy — the three-drug cocktail used to treat HIV — <a href="https://www.msf.org/untangling-web-antiretroviral-price-reductions-14th-edition">cost over US $10,000 per person per year</a>, effectively putting it out of reach of the vast majority of South Africans. </p>
<p>South Africa wanted to encourage the use of low-cost generic drugs. The response from 39 drug companies, backed by the United States, was to take South Africa to court. Canada’s position? We <a href="http://jmcti.org/2000round/build-in-agenda/service/S_CSS_W_046.pdf">supported access but we also supported the intellectual property rights of the drug companies</a>.</p>
<h2>C-TAP, COVAX and the WTO TRIPS waiver</h2>
<p>Fast forward to the present and COVID-19. In May 2020, the World Health Organization launched the <a href="https://www.who.int/news-room/detail/29-05-2020-international-community-rallies-to-support-open-research-and-science-to-fight-covid-19">COVID-19 Technology Access Pool</a>, or C-TAP, an initiative to accelerate and broaden global access to COVID-19 vaccines under development at the time, as well as treatments and diagnostics. </p>
<p>C-TAP has the <a href="https://www.who.int/initiatives/covid-19-technology-access-pool/endorsements-of-the-solidarity-call-to-action">endorsement of 40 countries</a>. But not Canada. No pharmaceutical company has contributed to C-TAP. <a href="https://www.statnews.com/pharmalot/2020/05/28/who-voluntary-pool-patents-pfizer/">Pfizer CEO Albert Bourla said</a>: “At this point in time, I think it’s nonsense, and… it’s also dangerous.”</p>
<figure class="align-center ">
<img alt="A policeman standing on a skip with crates of vaccine." src="https://images.theconversation.com/files/400125/original/file-20210511-23-x2rlm8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/400125/original/file-20210511-23-x2rlm8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/400125/original/file-20210511-23-x2rlm8.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/400125/original/file-20210511-23-x2rlm8.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/400125/original/file-20210511-23-x2rlm8.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/400125/original/file-20210511-23-x2rlm8.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/400125/original/file-20210511-23-x2rlm8.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A Malawian policeman guards AstraZeneca COVID-19 vaccines after the shipment arrived in March at the Kamuzu International Airport in Lilongwe, Malawi.</span>
<span class="attribution"><span class="source">(AP Photo/Thoko Chikondi, File)</span></span>
</figcaption>
</figure>
<p>COVAX is designed to give poor countries enough vaccine for 20 per cent of their population, but it is <a href="https://www.devex.com/news/covax-facility-seeks-an-additional-2b-for-covid-19-vaccines-99671">$2 billion short</a> of even achieving that modest objective.</p>
<p>In the face of the failure of C-TAP and in order to supplement what COVAX could do, back in October 2020 India and South Africa asked the World Trade Organization to <a href="https://www.barrons.com/articles/the-arguments-against-sharing-covid-19-intellectual-property-dont-add-up-51620056595">suspend the protection of intellectual property</a>.</p>
<p>The request included patent rights, technical know-how and undisclosed data for COVID-19 products for the duration of the pandemic. This is known as the TRIPS (Trade-Related Aspects of Intellectual Property Rights) waiver. The objective was to free up unused worldwide capacity to increase the production of vaccines and other products necessary for the prevention and treatment of COVID-19.</p>
<p>As many <a href="https://www.theglobeandmail.com/business/commentary/article-suspending-covid-19-vaccine-patents-is-morally-correct-but-wont-move/">commentators have pointed out</a>, if the waiver is approved by the WTO (and approval requires consensus among all its 159 members), nothing will change overnight. It will take many months and possibly even longer to ramp up vaccine production. </p>
<p>But that increased capacity is going to be needed. It is increasingly looking like we might require <a href="https://www.nationalgeographic.com/science/article/why-annual-covid-19-boosters-may-become-the-norm">yearly booster shots for COVID-19</a> as variants multiply. That’s almost six billion doses of vaccine a year for people 15 years and older, <a href="https://www.barrons.com/articles/the-arguments-against-sharing-covid-19-intellectual-property-dont-add-up-51620056595">almost double the current capacity to produce vaccines</a>. </p>
<p>Moreover, when drug companies think that the pandemic is over, they are going to raise prices dramatically. Pfizer currently charges US$19.50 per dose, but chief financial officer Frank D’Amelio said that <a href="https://www.fiercepharma.com/pharma/pfizer-eyes-higher-covid-19-vaccine-prices-after-pandemic-exec-analyst">Pfizer’s normal price for vaccines is $150 to $175</a>.</p>
<h2>Canada’s position on intellectual property</h2>
<p>To the amazement of just about everyone, the Biden administration just announced that the U.S. is going to <a href="https://www.cnn.com/2021/05/05/politics/vaccine-patent-waivers/index.html">support the waiver</a> for COVID-19 vaccines.</p>
<p>Canada? Just like the South Africa situation, we neither support nor oppose the waiver. The Canadian government will take part in talks at the WTO about the waiver, but won’t say which side it will be taking. </p>
<figure class="align-center ">
<img alt="A motorcade of police cars and a truck." src="https://images.theconversation.com/files/400126/original/file-20210511-23-1cxa0na.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/400126/original/file-20210511-23-1cxa0na.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=418&fit=crop&dpr=1 600w, https://images.theconversation.com/files/400126/original/file-20210511-23-1cxa0na.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=418&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/400126/original/file-20210511-23-1cxa0na.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=418&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/400126/original/file-20210511-23-1cxa0na.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=525&fit=crop&dpr=1 754w, https://images.theconversation.com/files/400126/original/file-20210511-23-1cxa0na.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=525&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/400126/original/file-20210511-23-1cxa0na.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=525&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A police escort follows the shipment carrying just under 300,000 doses of the single-shot Johnson & Johnson COVID-19 vaccine, which is developed by the Janssen Pharmaceutical Companies, at Pearson International Airport in Toronto on April 28.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Nathan Denette</span></span>
</figcaption>
</figure>
<p>Canada’s position for months has been that it was “<a href="https://www.theglobeandmail.com/politics/article-trudeau-wont-state-position-on-covid-19-vaccine-patent-waiver-as/">merely asking questions about the patent waiver proposal, rather than opposing it</a>.” But in a <a href="https://patentdocs.typepad.com/files/2021-03-05-phrma-letter.pdf">letter to the U.S. government</a> back in March from the Pharmaceutical Research and Manufacturers of America, Canada was listed as one of the countries standing with the U.S. in opposing the waiver.</p>
<p>Canada is <a href="https://www.theglobeandmail.com/politics/article-canada-to-take-part-in-talks-over-vaccine-patent-waivers-but-wont/">currently negotiating with drug companies over vaccine delivery schedules</a> and is still in a battle with them about changes to <a href="http://innovativemedicines.ca/pmprb-regulations-delayed/">how prices for patented drug will be determined</a>. </p>
<p>Innovative Medicines Canada (IMC), the lobby group for the multinational companies, not surprisingly has come out strongly against the waiver. <a href="http://innovativemedicines.ca/innovative-medicines-canada-cautions-covid-19-trips-ip-waiver/">In a statement</a> a few days after the U.S. announced its position, IMC said the “proposed waiver of TRIPS IP protections would be a disappointing step that will create greater uncertainty and unpredictability in the production, quality, and availability of COVID-19 vaccines worldwide.” </p>
<p>How much is fear of further angering the pharmaceutical industry playing into Canada’s position on the waiver?</p>
<p>When it comes to standing up for access to medicines versus standing up for intellectual property rights, for Canada, plus ça change, plus c’est la même chose; the more things change, the more they stay the same.</p><img src="https://counter.theconversation.com/content/160685/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2017-2020, Joel Lexchin received payments for being on a panel at the American Diabetes Association, for talks at the Toronto Reference Library, for writing a brief in an action for side effects of a drug for Michael F. Smith, Lawyer and a second brief on the role of promotion in generating prescriptions for Goodmans LLP and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p>Despite some public virtue signalling, the Canadian government is not doing all it can to improve global access to COVID-19 vaccines. Canada has yet to announce its position on the WTO patent waiver.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/1556232021-03-17T15:59:00Z2021-03-17T15:59:00ZPeru’s COVID-19 vaccine scandal shows the shady deals made with pharma companies<figure><img src="https://images.theconversation.com/files/389087/original/file-20210311-19-d3mta2.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C5472%2C3645&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A woman who said she's a medical worker who works directly with COVID-19 patients is stopped by police outside of the public Rebagliati Hospital in Lima, Peru, in February 2021. She complained that some people getting vaccinated don't work directly with COVID-19 patients.</span> <span class="attribution"><span class="source">(AP Photo/Martin Mejia)</span></span></figcaption></figure><p>The COVID-19 vaccination gap is evident, with <a href="https://www.aljazeera.com/news/2021/2/17/un-chief-urges-global-plan-to-reverse-unfair-vaccine-access">10 countries accounting for almost three-quarters of the vaccines administered globally</a>. </p>
<p>In the race to control the pandemic and reach herd immunity, countries in the Global South are being charged more than countries in the Global North. <a href="https://us14.campaign-archive.com/?u=eebd66b68746be9844586842a&id=ba2d96a794">AstraZeneca, for example, charges US$5.25 per dose to South Africa compared to US$2.16 to the European Union</a>. </p>
<p>Vaccine acquisition and distribution are also presenting different problems for different countries. </p>
<p>In Canada, managers of long-term care homes and their relatives allegedly <a href="https://www.cbc.ca/news/canada/toronto/villa-leonardo-gambin-care-home-covid-vaccine-1.5903747">queue-jumped</a> to obtain early access to vaccines over more vulnerable people. In Germany, <a href="https://www.thelocal.de/20210212/premature-vaccine-jabs-given-out-in-at-least-nine-german-states/">politicians were found to be skipping the vaccination line</a>, while in Peru, a vaccination scandal <a href="https://www.bbc.com/mundo/noticias-america-latina-56114937">dubbed VacunaGate</a> has erupted.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/372417/original/file-20201202-16-1cx8tgg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A man with glasses and dark hair smiles." src="https://images.theconversation.com/files/372417/original/file-20201202-16-1cx8tgg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/372417/original/file-20201202-16-1cx8tgg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=427&fit=crop&dpr=1 600w, https://images.theconversation.com/files/372417/original/file-20201202-16-1cx8tgg.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=427&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/372417/original/file-20201202-16-1cx8tgg.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=427&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/372417/original/file-20201202-16-1cx8tgg.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=537&fit=crop&dpr=1 754w, https://images.theconversation.com/files/372417/original/file-20201202-16-1cx8tgg.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=537&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/372417/original/file-20201202-16-1cx8tgg.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=537&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">In this October 2019 photo, President Martin Vizcarra smiles after the swearing-in ceremony of his new cabinet at the government palace in Lima, Peru.</span>
<span class="attribution"><span class="source">(AP Photo/Martin Mejia)</span></span>
</figcaption>
</figure>
<p>It involves former president Martin Vizcarra and his wife, former ministers of health and foreign affairs, vice-ministers, negotiators, high-profile lobbyists and family members of those in charge of the clinical trial meant to test the efficacy of the Chinese Sinopharm vaccine. </p>
<p><a href="https://saludconlupa.com/noticias/vacunagate-los-487-que-se-beneficiaron-en-secreto-de-las-dosis-de-sinopharm/">Almost 500 people jumped the queue</a> and obtained an early “courtesy” dose of the Sinopharm vaccine while still negotiating with the company. The Chinese firm provided more doses than those required for the trial and received a conditional sanitary registry <a href="https://sudaca.pe/noticia/informes/los-atajos-de-la-vacuna-de-sinopharm-en-el-peru">under irregular circumstances</a>. </p>
<h2>Peruvian corruption</h2>
<p>This episode is just the latest in a long history of corruption in Peru that has stirred public outrage. <a href="https://coronavirus.jhu.edu/map.html">More than a million Peruvians have been infected with COVID-19 and almost 50,000 have died</a>.</p>
<p>Some of the queue-jumpers — those directly implicated in the negotiation process with Sinopharm — may face three to eight years in jail. Public servants who obtained “courtesy” vaccines for themselves or others might be charged with corruption. If any of those officials requested or accepted something in return for those vaccines, their actions might qualify as bribery. </p>
<p>Civil servants who unduly favour one company over others and company officials acting as counterparts in these negotiations may be charged with collusion. Not everyone who obtained courtesy vaccines has the same degree of criminal responsibility and will face the same potential criminal repercussions, raising questions about how we determine what’s immoral conduct, illegal misconduct or both.</p>
<p>The legal questions are still up in the air, and currently a substantial investigation is underway. The scandal also raises concerns about Sinopharm’s practices because it’s the company that provided those extra shots to politicians, their family members, lobbyists and even the <a href="https://www.catholicnewsagency.com/news/bishops-conference-condemns-peru-vaccine-scandal-27982">Pope’s representative in Peru</a>.</p>
<h2>The clinical trials</h2>
<p>Clinical trials happen in multiple phases. Phase 1 tests safety. Participants in Phase 1 are usually given small doses of the vaccine and researchers will look for side-effects that occur.</p>
<p>Phase 2 looks for utility. Participants in Phase 2 are usually divided into groups who are given different doses of the vaccine, and researchers will determine which dose appears to provide the most protection, if any.</p>
<p>Phase 3 tests the optimal effectiveness of the final product. Participants in Phase 3 are given the most effective dose established in Phase 2 and researchers examine whether this dose is adequately effective on large populations.</p>
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Read more:
<a href="https://theconversation.com/explainer-how-clinical-trials-test-covid-19-vaccines-146061">Explainer: How clinical trials test COVID-19 vaccines</a>
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<hr>
<p>The trials that took place in Peru beginning in September were <a href="https://andina.pe/agencia/noticia-coronavirus-hoy-se-iniciaron-los-ensayos-clinicos-vacuna-anticovid-china-813110.aspx?fbclid=IwAR2CkgDngcR8pzT5RTyChjUIyd2GwwL2th_UKg9sI-kkp-bLz2odvx5HN4s">Phase 3 trials</a>. Sinopharm had completed up to Phase 2 before then, but not Phase 3. </p>
<p>For both Canada and Peru, a critical part of research ethics <a href="https://dx.doi.org/10.1179%2F106698111X12899036752014">is the principle known as <em>equipoise</em></a>. Equipoise states that trials are only ethical if there is genuine uncertainty that the intervention in question is more effective than the current standard of care for the target population. </p>
<p>For these Phase 3 Peruvian trials, the intervention in question is the Sinopharm vaccine, and the standard of care is nothing because Peru had not approved other vaccines at that time. Because there was no standard of care to compare it to, such as other vaccines, the Sinopharm vaccine was compared against a placebo.</p>
<p>If Sinopharm presented these “courtesy” vaccines as samples, it implies that they were known to be adequately effective even before Phase 3 trials were complete. If they were known to be adequately effective, it was unethical for Sinopharm to have conducted a trial to analyze their efficacy in Peru because that would violate equipoise principles. </p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/389953/original/file-20210316-15-1jjsyz0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="Empty vials of China's Sinopharm vaccine sit in a cup" src="https://images.theconversation.com/files/389953/original/file-20210316-15-1jjsyz0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/389953/original/file-20210316-15-1jjsyz0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=374&fit=crop&dpr=1 600w, https://images.theconversation.com/files/389953/original/file-20210316-15-1jjsyz0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=374&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/389953/original/file-20210316-15-1jjsyz0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=374&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/389953/original/file-20210316-15-1jjsyz0.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=470&fit=crop&dpr=1 754w, https://images.theconversation.com/files/389953/original/file-20210316-15-1jjsyz0.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=470&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/389953/original/file-20210316-15-1jjsyz0.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=470&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Empty vials of China’s Sinopharm vaccine sit in a cup during a priority COVID-19 vaccination campaign of health workers at a public hospital in Lima, Peru, in February 2021.</span>
<span class="attribution"><span class="source">(AP Photo/Martin Mejia)</span></span>
</figcaption>
</figure>
<p>On the other hand, this was a new Phase 3 trial that passed an ethics review. That means the more likely option is that Sinopharm did not know the vaccines were adequately effective when they offered them to politicians. </p>
<p>This suggests Sinopharm might have provided untested vaccines to people outside of the trial. This is also unethical because it is dangerous and can undermine the scientific integrity of the trial. Either way, the two acts of giving “courtesy” vaccinations while simultaneously conducting a clinical trial violate commonly upheld ethical guidelines.</p>
<h2>The danger of confidentiality</h2>
<p>It is common practice for pharmaceutical companies to demand confidentiality clauses in their contracts with governments. For this reason, countries <a href="https://globalnews.ca/news/7623525/coronavirus-vaccine-contract-confidentiality-clause-anita-anand/">like Canada</a> <a href="https://gestion.pe/peru/vacuna-covid-19-minsa-solo-publicara-informacion-general-que-no-afecte-acuerdos-de-confidencialidad-con-laboratorios-coronavirus-segunda-ola-nndc-noticia/">and Peru</a> are unable to release all relevant information about these contracts to the public. </p>
<p>But how these deals are reached and what pharmaceutical companies do to win them should worry us. Due to the world shortage of vaccines, some countries might be in a poor bargaining position compared to their peers or pharmaceutical companies.</p>
<figure class="align-center ">
<img alt="An Air Force member closes her eyes while getting a vaccination." src="https://images.theconversation.com/files/389949/original/file-20210316-17-1hpo8zp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/389949/original/file-20210316-17-1hpo8zp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=404&fit=crop&dpr=1 600w, https://images.theconversation.com/files/389949/original/file-20210316-17-1hpo8zp.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=404&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/389949/original/file-20210316-17-1hpo8zp.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=404&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/389949/original/file-20210316-17-1hpo8zp.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=508&fit=crop&dpr=1 754w, https://images.theconversation.com/files/389949/original/file-20210316-17-1hpo8zp.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=508&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/389949/original/file-20210316-17-1hpo8zp.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=508&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">An Air Force member closes her eyes while getting a shot of Pfizer’s vaccine for COVID-19 at a military base in Lima, Peru, in March 2021.</span>
<span class="attribution"><span class="source">(AP Photo/Martin Mejia)</span></span>
</figcaption>
</figure>
<p>Simultaneously, some pharmaceutical companies might also take advantage of the inability of some governments to properly tackle corruption to win over those markets when competing with other pharmaceuticals. Vaccination queue-jumping and “courtesy” samples can lead to quid pro quo arrangements to the detriment of fair and transparent vaccination rollouts. </p>
<p>The Peruvian revelations have caused a massive uproar in the South American country. But they could also be a wake-up call for all nations to allow further investigations regarding Sinopharm’s business practices around the world.</p><img src="https://counter.theconversation.com/content/155623/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Denisse Rodriguez-Olivari receives funding from DAAD (German Academic Exchange Service).</span></em></p><p class="fine-print"><em><span>Jorge H. Sanchez-Perez and Leanne Woodward 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 vaccination queue-jumping scandal in Peru has caused a massive uproar in the South American country. It could also be a wake-up call for all nations.Jorge H. Sanchez-Perez, Ph.D. Candidate - School of Humanities, Department of Philosophy, Instructor - Philosophy Department and Peace Studies Program, McMaster UniversityDenisse Rodriguez-Olivari, PhD candidate in Political Science, Humboldt University of BerlinLeanne Woodward, PhD Student, Research Ethics, University of WaterlooLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1495862021-01-13T19:58:57Z2021-01-13T19:58:57ZThe price of a drug should be based on its therapeutic benefits – not just what the market will bear<figure><img src="https://images.theconversation.com/files/377459/original/file-20210106-21-rcy5o8.jpg?ixlib=rb-1.1.0&rect=0%2C25%2C5615%2C3707&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The average price for an orphan drug is more than $150,000 per year.</span> <span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/photo/pills-decorated-with-dollar-bills-royalty-free-image/155292424?adppopup=true">GP Kidd/Cultura/Getty Images</a></span></figcaption></figure><p>The U.S. pharmaceutical industry has <a href="https://theconversation.com/how-mrna-vaccines-from-pfizer-and-moderna-work-why-theyre-a-breakthrough-and-why-they-need-to-be-kept-so-cold-150238">innovated in response to the pandemic</a>, providing not <a href="https://theconversation.com/oxford-astrazeneca-vaccine-is-cheaper-than-pfizers-and-modernas-and-doesnt-require-supercold-temperature-150697">only vaccines</a> but also <a href="https://theconversation.com/trump-is-taking-the-latest-in-covid-19-treatments-heres-what-doctors-know-works-against-the-virus-147398">therapies to treat people with COVID-19</a>. But an outdated law designed to spur development of lifesaving drugs risks making new treatments – for COVID-19 as well as other diseases – unaffordable for many Americans.</p>
<p>Many pharmaceutical companies rely on the <a href="https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/orphan-drug-act-relevant-excerpts">Orphan Drug Act</a>, which <a href="https://www.washingtonpost.com/archive/politics/1983/01/05/reagan-signs-orphan-drug-bill-despite-reservations/0dc60b40-09b9-4c68-ad8e-7a7469785876/">President Ronald Reagan signed</a> into law in 1983, to bring cutting-edge treatments to market quickly. The act gives pharmaceutical companies tax credits, market exclusivity and other incentives to develop drugs for “orphan” diseases, which are defined as illnesses that afflict fewer than 200,000 people in the U.S. Such diseases include <a href="https://www.ninds.nih.gov/Disorders/All-Disorders/Amyotrophic-Lateral-Sclerosis-ALS-Information-Page">amyotrophic lateral sclerosis</a> and <a href="https://www.ninds.nih.gov/disorders/patient-caregiver-education/fact-sheets/tourette-syndrome-fact-sheet">Tourette syndrome</a>, but also ones like <a href="https://www.niaid.nih.gov/diseases-conditions/malaria">malaria</a> that are rare in the U.S. but are major killers globally. </p>
<p>But, as <a href="https://doi.org/10.1016/j.jval.2012.09.004">scholars</a> and access-to-medicines advocates have argued, the Orphan Drug Act has flaws that risk keeping prices high.</p>
<p><a href="https://global-health-impact.org/nhassoun/">I’m a bioethicist</a> who has studied global health and access to essential medical innovations. I believe there’s an alternative to that modifies the rewards the Orphan Drug Act offers based on the value of a drug – <a href="https://doi.org/10.1371/journal.pone.0141374">its impact on global health</a>. </p>
<h2>The Orphan Drug Act</h2>
<p>Before policymakers passed the law, pharmaceutical companies focused their efforts on developing treatments for mainstream diseases that afflicted millions of people. It was their way to maximize profit.</p>
<p>But the Orphan Drug Act, in addition to creating tax incentives and credits, enables companies to get a priority review voucher that effectively <a href="https://sites.fuqua.duke.edu/priorityreviewvoucher/#:%7E:text=The%20voucher%20entitles%20the%20bearer,than%20the%20standard%20ten%20months">extends the length of their patent</a> on a drug of their choice. That’s because when the FDA reviews a drug quickly, the medicine can be sold under patent for longer. <a href="https://www.raps.org/regulatory-focus/news-articles/2017/12/regulatory-explainer-everything-you-need-to-know-about-fdas-priority-review-vouchers">Companies can sell this voucher for millions of dollars</a> to other pharmaceutical companies.</p>
<p>The Orphan Drug Act was brilliant, until <a href="https://www.mdedge.com/hematology-oncology/article/186913/pharmacy/pharma-gaming-system-orphan-drugs-investigation-suggests?sso=true;%20https://khn.org/news/drugmakers-manipulate-orphan-drug-rules-to-create-prized-monopolies/">pharmaceutical companies began to find loopholes</a>. Companies could obtain orphan drug status for an ever-growing collection of diseases that officially qualify as rare but were actually just subpopulations of very common diseases. For example, <a href="https://www.drugs.com/humira.html">Humira</a>, made by AbbVie, is the best-selling drug in the world for rheumatoid arthritis and other inflammatory diseases, and yet it <a href="https://khn.org/news/drugmakers-manipulate-orphan-drug-rules-to-create-prized-monopolies/">received orphan drug status for juvenile rheumatoid arthritis</a>. </p>
<h2>COVID-19 and Remdesivir</h2>
<p>As hundreds of Americans are still dying from COVID-19 every day, new treatments are essential, and it’s imperative that they’re affordable. </p>
<p>When the COVID-19 pandemic first came to the U.S., and fewer than 200,000 people here were sick, Gilead applied for orphan <a href="https://doi.org/10.1001/jamainternmed.2020.2759">drug status</a> for the antiviral drug Remdesivir – one of the only existing treatments for SARS-CoV-2. </p>
<p>There was big public outcry that Gilead was abusing the system to get taxpayer benefits and more market exclusivity <a href="https://www.statnews.com/2020/10/22/remdesivir-hefty-price-tag-ignores-nih-investment-in-its-creation/">even though Remdesivir was developed with public funding</a>. Gilead was repurposing Remdesivir for COVID-19, and it was clearly going to be sold to a mass market. After significant public backlash, <a href="https://www.fiercepharma.com/pharma/gilead-asks-fda-to-rescind-remdesivir-orphan-drug-tag-after-public-backlash">Gilead retracted its orphan drug application</a>. </p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/378414/original/file-20210112-23-10nb4l6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/378414/original/file-20210112-23-10nb4l6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/378414/original/file-20210112-23-10nb4l6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/378414/original/file-20210112-23-10nb4l6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/378414/original/file-20210112-23-10nb4l6.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/378414/original/file-20210112-23-10nb4l6.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/378414/original/file-20210112-23-10nb4l6.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/378414/original/file-20210112-23-10nb4l6.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">A pack containing vials of Remdesivir, a broad-spectrum antiviral medication approved as a specific treatment for COVID-19.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/june-2020-egypt-giza-an-employee-of-egyptian-pharmaceutical-news-photo/1223461280?adppopup=true">Fadel Dawood/picture alliance via Getty Images</a></span>
</figcaption>
</figure>
<p>Companies are still trying to repurpose orphan drugs for the COVID-19 mass market while keeping the high price tag. This is the case with Pembrolizumab, an orphan drug for melanoma and gastric cancer that is currently being tested as a potential medication for COVID-19. It costs US$5,834 per 4 milliliters, a price the majority of Americans simply cannot afford. Companies are <a href="https://www.healthaffairs.org/do/10.1377/hblog20200623.498157/full">testing many other orphan drugs</a> for COVID-19 as well. In 2018, the average cost of an orphan drug was <a href="https://www.healthaffairs.org/do/10.1377/hblog20200623.498157/full%20a%20more%20recent%20estimate%20is%20here:%20https://www.ahip.org/drug-prices-for-rare-diseases-skyrocket-while-big-pharma-makes-record-profits/#:%7E:text=The%20average%20annual%20orphan%20drug,selling%20drugs%20had%20orphan%20indications">$150,854</a> per patient per year. </p>
<p>Companies also claim credits for drugs that are neither novel nor important. Companies often <a href="https://www.fiercepharma.com/pharma/gilead-asks-fda-to-rescind-remdesivir-orphan-drug-tag-after-public-backlash">repurpose old drugs to treat orphan conditions</a> that may have been used to treat patients “off label” – or without official FDA approval – for a long time. Sometimes companies find orphan diseases that can be <a href="https://www.npr.org/sections/health-shots/2018/11/30/672287029/fda-faulted-for-lapses-in-orphan-drug-program">treated with their blockbuster drugs</a>. Or they slice major diseases, like breast cancer, into smaller and smaller parts <a href="https://www.yalejreg.com/nc/a-congressional-inquiry-into-orphan-drugs/">to get an orphan drug designation</a>. For example, almost any cancer can be subdivided based on genetic differences until the population of those suffering from it falls below the 200,000 orphan drug threshold. Herceptin is used to treat breast cancer, but AstraZeneca and Daiichi Sankyo received <a href="https://www.cnbc.com/2015/12/01/an-obscure-fda-rule-adding-to-drug-company-profits.html;%20https://www.ajmc.com/view/trastuzumab-deruxtecan-gets-orphan-drug-status-for-gastric-cancer">orphan drug designation for testing the drug for gastric cancer</a>, despite the fact that it is a blockbuster drug. </p>
<h2>How to fix the orphan drug problem</h2>
<p>Some regulators and researchers propose <a href="https://www.yalejreg.com/nc/a-congressional-inquiry-into-orphan-drugs/">limiting the length of market exclusivity for orphan drugs</a> if a disease no longer qualifies as orphan, or after six years. Others suggest only <a href="https://www.statnews.com/2019/12/19/orphan-drug-act-nonprofitability-loophole-needs-closing/">granting orphan drug status</a> for new compounds or those that will not otherwise be economically viable. </p>
<p>The government can still reward companies for their efforts with tax and research incentives and give them priority review vouchers for new innovations. But I propose that these rewards should be based on their innovations’ <a href="https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0141374">health impact</a>, and companies should agree to open access licenses that allow generic companies to produce these drugs as well. The more lives companies’ innovations save, and the greater the improvement in quality of life, the greater the reward. </p>
<p>Researchers can extend existing analysis of medicines’ <a href="http://global-health-impact.org/new">global health impact</a> for this purpose by considering the need for, access to, and effectiveness of new innovations. So, for example, if two new drugs were invented for an orphan disease, but one saved 10 times as many lives, the first drug would get 10 times the rewards – in terms of tax benefits, length of exclusivity, and other benefits.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/378661/original/file-20210113-17-16yvmzx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/378661/original/file-20210113-17-16yvmzx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/378661/original/file-20210113-17-16yvmzx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/378661/original/file-20210113-17-16yvmzx.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/378661/original/file-20210113-17-16yvmzx.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/378661/original/file-20210113-17-16yvmzx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=502&fit=crop&dpr=1 754w, https://images.theconversation.com/files/378661/original/file-20210113-17-16yvmzx.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=502&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/378661/original/file-20210113-17-16yvmzx.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=502&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Drugs and therapies that relieve the greatest amount of suffering should earn the greatest rewards.</span>
<span class="attribution"><a class="source" href="https://www.gettyimages.com/detail/news-photo/rotarian-iftekharul-alam-administers-the-oral-polio-vaccine-news-photo/664704?adppopup=true">Jean-Marc Giboux/Liaison/Hulton Archive/Getty Images</a></span>
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</figure>
<p>I also think that orphan drugs’ production should be made open access to bring costs down to the marginal cost of production. Doing so is better than rewarding companies based on patients’ willingness to pay. Right now, companies make the most money by <a href="https://www.amazon.com/Global-Health-Impact-Extending-Essential/dp/0197514995">selling drugs to rich patients for chronic conditions</a> like allergies that they can treat but do not cure. </p>
<p>My proposal is to uncouple profits from sales volume and reward companies based on the health impact of the new therapy, if they agree to allow any company to manufacture the resulting products. </p>
<p>Tax breaks and the length of the FDA review process specified in the voucher might be based on how many lives new innovations save and how much disability they alleviate. There are already some <a href="https://www.msf.org/nobel-funds-allocated-neglected-diseases">prize funds</a> that <a href="https://www.keionline.org/sites/default/files/Love_Hubbard_Big_Idea.pdf">reward</a> companies for doing research on diseases that do not affect many people in the U.S. but are big global killers. Similarly, so-called advance market commitments often reward companies for creating new medicines that have a large impact. And <a href="https://www.cgdev.org/blog/price-right-evaluating-advanced-market-commitments-vaccines">economic evaluation</a> based on health impact can help us set appropriate thresholds for rewards.</p>
<p>Right now, companies focus on providing new treatments for chronic diseases of rich patients rather than on having the greatest health impact. That’s how they make the most money. Changing this system would shift the the whole pharmaceutical industry’s priorities.</p><img src="https://counter.theconversation.com/content/149586/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Nicole Hassoun receives funding from the World Health Organization (pending). </span></em></p>‘Orphan drugs’ with high price points are being tested as treatments for COVID-19. There’s a better way to spur low-cost innovation for new drugs.Nicole Hassoun, Professor of Philosophy, Binghamton University, State University of New YorkLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1499722020-11-17T18:52:36Z2020-11-17T18:52:36ZYou may be able to buy a COVID vaccine ahead of the government rollout. But jumping the queue comes at a price<figure><img src="https://images.theconversation.com/files/369027/original/file-20201112-17-1evbsoi.jpg?ixlib=rb-1.1.0&rect=1%2C0%2C997%2C666&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/mini-shopping-trolley-syringes-injections-vaccines-1777009550">Shutterstock</a></span></figcaption></figure><p>As the world <a href="https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6">continues to battle</a> COVID-19, the prospect of a vaccine gives us hope of returning to some kind of “normal” in the not too distant future.</p>
<p>The Australian government has signed supply agreements with manufacturers of <a href="https://www.health.gov.au/sites/default/files/documents/2020/11/australian-covid-19-vaccination-policy_1.pdf">four COVID vaccines</a> currently in clinical trials. Assuming one or more meets the requirements for safety and effectiveness, everyone will be able to be vaccinated for free.</p>
<p>However, as vaccine supply will be limited at least initially, the government has specified certain groups that will <a href="https://www.health.gov.au/sites/default/files/documents/2020/11/australian-covid-19-vaccination-policy_1.pdf">take priority to receive vaccines first</a>. These include people at higher risk of exposure to COVID-19 (such as health-care workers), and those who are more vulnerable to severe disease (such as older people). </p>
<p>At the same time, the head of the Therapeutic Goods Administration (TGA), John Skerritt, has noted manufacturers will also be able to <a href="https://www.abc.net.au/news/2020-11-11/coronavirus-pfizer-vaccine-eskies/12871888">sell vaccines privately</a>:</p>
<blockquote>
<p>We live in a free market economy […] There’s nothing stopping companies as long as they have the TGA approval to put that vaccine on the market in Australia.</p>
</blockquote>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/90-efficacy-for-pfizers-covid-19-mrna-vaccine-is-striking-but-we-need-to-wait-for-the-full-data-149818">90% efficacy for Pfizer's COVID-19 mRNA vaccine is striking. But we need to wait for the full data</a>
</strong>
</em>
</p>
<hr>
<p>This arrangement reinforces the <em>status quo</em> of Australia’s health system: a public health system with a private market on the side. But COVID is not the <em>status quo</em>. It’s a global public health emergency that has already claimed more than <a href="https://coronavirus.jhu.edu/map.html">1.3 million lives</a>. </p>
<p>Allowing people to jump the queue via the private market is a bad idea, for several reasons.</p>
<h2>1. A private market puts wealth ahead of need</h2>
<p>Those most likely to buy the vaccine privately are those who have not been deemed at high enough risk to receive the vaccine for free until later on, but have the means to do so (we don’t know yet how much it might cost).</p>
<p>Prices are often higher in the private sector because public drug schemes <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4194861/">benefit from their size and bargaining power</a> to keep prices low, which could lead vaccine manufacturers to prioritise private sales. If companies set aside a portion of their limited supply for private sales, people who need the vaccine the most, such as health workers and older people, may have to wait longer. </p>
<p>If there are exceptions where people who don’t fall into the priority categories need a vaccine, such as for essential travel to a country that mandates vaccination as a condition of entry, the answer is to build in flexibility through special access requests, not private sales. </p>
<figure class="align-center ">
<img alt="A woman receives a vaccination from a health-care worker." src="https://images.theconversation.com/files/369702/original/file-20201117-23-183qfuh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/369702/original/file-20201117-23-183qfuh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/369702/original/file-20201117-23-183qfuh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/369702/original/file-20201117-23-183qfuh.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/369702/original/file-20201117-23-183qfuh.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/369702/original/file-20201117-23-183qfuh.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/369702/original/file-20201117-23-183qfuh.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">If and when a COVID vaccine becomes available, older people will be towards the front of the queue.</span>
<span class="attribution"><span class="source">Shutterstock</span></span>
</figcaption>
</figure>
<h2>2. People buying privately may not get the vaccine they need</h2>
<p>Several vaccines may come onto the market, and we don’t yet know if all will be equally effective for everyone. For example, it’s possible a particular vaccine won’t work as well in <a href="https://theconversation.com/why-we-should-prioritise-older-people-when-we-get-a-covid-vaccine-148432">older people</a>. </p>
<p>The allure of private sales may lead companies to promote their vaccines, in turn affecting which one a patient gets. Drug companies have a long history of intensive marketing to doctors, often casting a wide net in terms of who they suggest might benefit. In the case of <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2622774/">the opioid epidemic</a>, these practices have been associated with <a href="https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2720914">serious harm</a> to patients.</p>
<p>Companies cannot advertise prescription-only products, including vaccines, to the public <a href="https://www.tga.gov.au/sites/default/files/australian-regulatory-guidelines-advertising-therapeutic-goods-argatg.pdf">in Australia</a>. But they can run unbranded <a href="https://www.smh.com.au/national/lyrica-pfizer-and-how-big-pharma-gets-what-it-wants-20190211-p50x1z.html">disease awareness campaigns</a> that indirectly promote products to consumers, <a href="https://www.mja.com.au/journal/2009/191/11/content-analysis-disease-awareness-advertisements-popular-australian-womens">often through emotional images and appeals</a>.</p>
<h2>3. Follow-up may be poorer</h2>
<p>COVID vaccine development is moving very quickly, with shorter pre-market testing than a vaccine would normally have. This makes it all the more important to keep careful track of who receives the vaccine, any health problems they experience, and longer-term effectiveness. Uncoordinated private provision creates extra logistical challenges for follow-up. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/why-we-should-prioritise-older-people-when-we-get-a-covid-vaccine-148432">Why we should prioritise older people when we get a COVID vaccine</a>
</strong>
</em>
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<hr>
<h2>4. Private supply may be impractical</h2>
<p>As an example, Pfizer’s mRNA-based vaccine must be stored <a href="https://theconversation.com/pfizers-ultra-cold-vaccine-could-be-difficult-to-distribute-149848">at -80°C</a>. Special cold chain management is not easy for any provider, but is likely better handled by larger-scale providers set up to deliver COVID vaccines.</p>
<p>Further, all COVID-19 vaccines are likely to require at least <a href="https://www.health.gov.au/news/health-alerts/novel-coronavirus-2019-ncov-health-alert/vaccines-and-treatments/australias-vaccine-agreements">two doses</a>. Especially if supply is limited, it may become challenging to make sure private patients get their second dose. And delays or missing the second dose will likely lead to lower effectiveness.</p>
<figure class="align-center ">
<img alt="Illustration of 3 stick figures reaching for COVID vaccine" src="https://images.theconversation.com/files/369026/original/file-20201112-19-uyfexe.jpg?ixlib=rb-1.1.0&rect=0%2C7%2C998%2C658&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/369026/original/file-20201112-19-uyfexe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/369026/original/file-20201112-19-uyfexe.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/369026/original/file-20201112-19-uyfexe.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/369026/original/file-20201112-19-uyfexe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/369026/original/file-20201112-19-uyfexe.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/369026/original/file-20201112-19-uyfexe.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">Allowing people who have the means to purchase a COVID vaccine privately isn’t equitable.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/human-stick-figures-reaching-covid19-vaccine-1766805665">Shutterstock</a></span>
</figcaption>
</figure>
<h2>An issue of equity</h2>
<p>Some 40 countries have joined the World Health Organisation’s <a href="https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/covid-19-technology-access-pool/solidarity-call-to-action">Solidarity Call to Action</a> to support equitable global access to COVID-19 health technologies. Similarly, <a href="https://www.gavi.org/vaccineswork/covax-explained">the COVAX initiative</a>, which Australia supports, provides direct funding for vaccine access in less advantaged countries. </p>
<p>Echoing the principles of these initiatives, Prime Minister <a href="https://www.hrw.org/report/2020/10/29/whoever-finds-vaccine-must-share-it/strengthening-human-rights-and-transparency">Scott Morrison</a> told the United Nations in September:</p>
<blockquote>
<p>[…] it’s a moral responsibility for a vaccine to be shared far and wide. Some might see short-term advantage or even profit, but I assure you, to anyone who may think along those lines, humanity will have a very long memory, and be a very, very severe judge.</p>
</blockquote>
<p>Given this moral responsibility, why allow wealthier Australians to jump the queue? The planned public rollout of free COVID-19 vaccines for all is laudable. The main rationale for a parallel private system is “short-term advantage or even profit”, to borrow the prime minister’s words. Let’s not go there.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/creating-a-covid-19-vaccine-is-only-the-first-step-itll-take-years-to-manufacture-and-distribute-144352">Creating a COVID-19 vaccine is only the first step. It'll take years to manufacture and distribute</a>
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<img src="https://counter.theconversation.com/content/149972/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Barbara Mintzes receives research funding from Australia's National Health and Medical Research Council (NHMRC) and is co-principal investigator on a research project funded by the Canadian Institutes of Health Research (CIHR). She is an expert witness for Health Canada on a legal case concerning marketing of an unapproved drug. She is a member of a non-profit associations supporting access to essential medicines and public interests in pharmaceutical policy, Health Action International (HAI-Europe) and of Association Mieux Prescrire, a French non-profit association that produces an independent drug bulletin, La Revue Prescrire (English version: Prescrire International). </span></em></p><p class="fine-print"><em><span>In 2017-2020, Joel Lexchin received payments for being on a panel at the American Diabetes Association, for talks at the Toronto Reference Library, for writing a brief in an action for side effects of a drug for Michael F. Smith, Lawyer and a second brief on the role of promotion in generating prescriptions for Goodmans LLP and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p><p class="fine-print"><em><span>Kellia Chiu is a PhD candidate at The University of Sydney and is supported by the university's PhD Scholarship in the Community Pharmacy – Research into Policy. </span></em></p><p class="fine-print"><em><span>Zhicheng (Jeff) Wang is employed by the National Centre for Immunisation Research and Surveillance (NCIRS), which receives funding from the Australian Government Department of Health, NSW Health, and the Sydney Children's Hospitals Network. He has not personally received any relevant external funding, including from any governments, foundations, or research council grants.</span></em></p>A private market should have no place in the rollout of a COVID vaccine.Barbara Mintzes, Associate professor, School of Pharmacy and Charles Perkins Centre, University of SydneyJoel 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 TorontoKellia Chiu, PhD Candidate and Pharmacist, University of SydneyZhicheng (Jeff) Wang, Adjunct Lecturer, School of Pharmacy, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1499802020-11-17T18:15:44Z2020-11-17T18:15:44ZBuying and distributing a COVID-19 vaccine will involve hard ethical and practical choices<figure><img src="https://images.theconversation.com/files/369727/original/file-20201117-13-1smf489.jpg?ixlib=rb-1.1.0&rect=0%2C20%2C6709%2C4446&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><span class="source">www.shutterstock.com'</span></span></figcaption></figure><p>The world was ablaze with hope following the <a href="https://www.bmj.com/content/371/bmj.m4347">announcement</a> last week that a vaccine developed by Pfiser and BioNTech may be more than 90% effective in preventing COVID-19.</p>
<p>New Zealand politicians were quick to point out 1.5 million doses had already been pre-purchased through a legally binding agreement signed in late September to buy any vaccine to emerge from the multilateral <a href="https://www.stuff.co.nz/national/health/coronavirus/122836617/coronavirus-new-zealand-signs-agreement-for-covid19-vaccine-for-half-of-population">COVAX facility</a>.</p>
<p>Within the week, a second potentially effective vaccine emerged from US biotech firm <a href="https://www.theguardian.com/world/2020/nov/16/moderna-covid-vaccine-candidate-almost-95-effective-trials-show">Moderna</a>. Health Minister Chris Hipkins <a href="https://www.rnz.co.nz/national/programmes/morningreport/audio/2018773105/chris-hipkins-won-t-say-if-nz-in-line-for-moderna-vaccine">would not say</a> if New Zealand had negotiated for this option.</p>
<p>But assuming an approved vaccine is coming, attention then turns to logistics. Funding, procurement, storage and distribution all raise significant questions about values, decision-making and ethics.</p>
<p>We know there are multiple candidates for a COVID-19 vaccine, but there will be few “winners”, as many countries have already pre-contracted substantial amounts based on calculated risk assessments of which will emerge first. Even then, the challenges will be immense.</p>
<p>For example, assuming the Pfizer vaccine does become available as a safe option, it must be held in “ultra-cold storage” at -70 degrees Celsius. As has been <a href="https://www.pharmasalmanac.com/articles/anticipating-the-logistics-of-a-covid-19-vaccination-effort">observed</a> already, “Distributing an effective COVID-19 vaccine to the global population will likely be the greatest logistical challenge since World War II.”</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1325767629890592771"}"></div></p>
<h2>Who gets a vaccine first?</h2>
<p>For New Zealand, as with all countries, the questions raised are complex: do we now spend a large amount of money to scale up a logistics, distribution and storage system for the Pfizer drug? Or should we wait for an alternative that is more effective, easier to transport and store, and possibly cheaper?</p>
<p>After all, the first available vaccine might not achieve the outcomes we want. But would it be fair (or feasible) to make the country wait?</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/moderna-follows-pfizer-with-exciting-vaccine-news-how-to-read-these-dramatic-developments-149935">Moderna follows Pfizer with exciting vaccine news – how to read these dramatic developments</a>
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</p>
<hr>
<p>Furthermore, because enough doses to treat everyone will <a href="https://www.pharmasalmanac.com/articles/anticipating-the-logistics-of-a-covid-19-vaccination-effort">not be available</a> immediately, it will be necessary to prioritise recipients. What are the country’s obligations here? Do we offer the vaccination first to the oldest, or the youngest, or the most vulnerable?</p>
<p>National health systems will have some idea about how to go about this, but wealthy countries have never faced an immediate requirement on this scale.</p>
<h2>An ethical framework</h2>
<p>Answering these questions means calling simultaneously on a number of different ethical perspectives:</p>
<ul>
<li><p>an ethic of justice to assess the fairness of a decision</p></li>
<li><p>an ethic of <a href="https://plato.stanford.edu/entries/consequentialism/">consequentialism</a> to look at outcomes</p></li>
<li><p>the ethics of obligations to see who we may have made commitments to</p></li>
<li><p>an ethic of care to look at individual cases, rather than relying on abstract logic.</p></li>
</ul>
<p>Only when we combine these perspectives can we begin to make sense of priorities.</p>
<p>The vaccine marketplace is a kind of oligopoly, with a few extremely large firms deciding which vaccines get made, when and at what price. Pharmaceutical companies are reluctant to invest in producing new vaccines for the developing world because they have little prospect of earning an attractive return.</p>
<p>While global organisations such as vaccine alliance <a href="https://www.gavi.org/">GAVI</a> have been instrumental in getting vaccines to developing countries, given the geopolitics of procurement it could be a long time before an effective COVID-19 option reaches the poorest populations.</p>
<p><div data-react-class="Tweet" data-react-props="{"tweetId":"1328307041732071424"}"></div></p>
<h2>The moral dimension</h2>
<p>All this points to the deeper ethical issue of inequality. Many agencies, including the World Health Organisation (WHO), have <a href="https://www.who.int/news-room/facts-in-pictures/detail/health-inequities-and-their-causes">demonstrated</a> that health outcomes are related to socio-economic, ethnic and gender inequalities. COVID-19 has only made these inequalities worse.</p>
<p>Only last week, for example, a <a href="https://www.bbc.com/news/uk-england-54892161">UK study</a> showed 57.7 more people per 100,000 have died in the poorest areas of northern England than in the rest of the country. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="https://theconversation.com/covid-19-vaccines-could-go-to-children-first-to-protect-the-elderly-147899">COVID-19 vaccines could go to children first to protect the elderly</a>
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<p>This matches <a href="https://www.weforum.org/agenda/2020/08/5-things-covid-19-has-taught-us-about-inequality/">other research</a> showing how the pandemic has disproportionately affected poorer families, including their being less likely to be able to work from home or adapt to home-schooling.</p>
<p>Limited or selective availability of a vaccine could exacerbate these problems. And while New Zealand may be in a relatively privileged position, this doesn’t mean there won’t be <a href="https://www.newsroom.co.nz/pro/nz-gets-vaccine-at-expense-of-poor-countries">negative consequences</a> for other countries.</p>
<p>This adds an international dimension to our national dilemma: we have a duty to protect our own citizens, but is there a way we can minimise harm to others at the same time?</p><img src="https://counter.theconversation.com/content/149980/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>The funding, procurement, storage and distribution of a vaccine present huge challenges to all governments, including New Zealand’s.Barbara Allen, Senior Lecturer in Public Management, Te Herenga Waka — Victoria University of WellingtonMichael Macaulay, Professor of Public Administration, Te Herenga Waka — Victoria University of WellingtonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1495192020-11-12T18:58:00Z2020-11-12T18:58:00ZGuidelines governing Canadian doctors’ relationships with pharma companies under review<figure><img src="https://images.theconversation.com/files/368043/original/file-20201106-15-mjekz.jpg?ixlib=rb-1.1.0&rect=44%2C22%2C4947%2C3383&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Over 90 per cent of Canadian doctors see pharmaceutical sales representatives.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p><a href="http://www.stacommunications.com/journals/cpm/2009/04-April%2009/029-Prism.pdf">More than 90 per cent of Canadian physicians</a> see pharmaceutical sales representatives, the men and women paid by drug companies to go from office to office promoting their companies’ wares. </p>
<p>There is almost no evidence that such interactions improve patient care: <a href="https://doi.org/10.1007/s11606-013-2411-7">Needed safety information on medicines is rarely provided</a> and, most of the time, the result is that <a href="https://doi.org/10.1371/journal.pmed.1000352">doctors prescribe more frequently, more expensively and less appropriately</a>.</p>
<p>In a 2015 survey of 1,000 Canadian doctors, almost half said that they were retained by a pharmaceutical company in some capacity at some point in their career. Most agreed with the statement, “<a href="http://www.lorimer.ca/adults/Book/2979/Doctors-in-Denial.html">I would not be able to serve my patients as well without the information provided to me by the pharmaceutical companies I have professional relationships with</a>.”</p>
<p>The Canadian Medical Association (CMA) is now <a href="https://ca.surveygizmo.com/s3/50087648/Guidelines-for-Physicians-in-Interactions-with-Industry-Oct-29-Brief">engaged in consultations</a> until Nov. 19, aimed at revising its 2007 guidelines for the <a href="https://policybase.cma.ca/en/permalink/policy9041#_ga=2.154191032.1603111395.1604695110-1195568230.1530309375">relationship between doctors and the pharmaceutical industry</a>. Such guidelines on conflict of interest are an important source of recommendations about how physicians should manage their interactions with the pharmaceutical industry.</p>
<p>The CMA <a href="http://www.lorimer.ca/adults/Book/2979/Doctors-in-Denial.html">first issued its guidelines in August 1991</a> at its annual meeting, where they were passed unanimously. At the time, CMA officials hailed the rules as more far-reaching and specific than any similar code in the world. Dr. Robert Woollard, chair of the committee that drew up the guidelines, said: </p>
<blockquote>
<p>“We were in danger of drifting into a variety of unacceptable practices which might have meant a danger to the profession.…These guidelines provide all physicians in Canada with a very clear expression of what their peers think should be the relationship between physicians and pharmaceutical companies.”</p>
</blockquote>
<p>Since then, the guidelines have been periodically revised. The current version has some strong points but also significant weaknesses. The guidelines are clear that when physicians submit articles to medical journals, they “must state any relationship they have to companies providing funding for the studies or that make the products that are the subject of the study whether or not the journals require such disclosure.”</p>
<p>But on the other hand, there are only two short paragraphs dealing with medical students and doctors in training, and almost nothing about “<a href="https://www.matteringpress.org/wp-content/uploads/2018/07/Sismondo-Ghost-managed-Medicine-2018-1.pdf">ghostwriting</a>.” The latter is the practice whereby companies contract out writing up medical journal articles to professional writers who craft a message favourable to the company. The company then finds prominent researchers or doctors who are willing to appear as “authors,” sometimes having made little or no contribution to the contents.</p>
<h2>Normalizing conflicts of interests</h2>
<p>Now is the time for the CMA to substantially strengthen its guidelines. To begin, the preamble needs to acknowledge that there are structural issues in the organization of medical practice and research that must be addressed through political channels. For example, one of the main reasons that doctors feel the need to give out samples is because Canada does not have a universal pharmacare program that would eliminate out-of-pocket costs. Another issue is that granting agencies often require researchers also secure matching funding from private for-profit sources.</p>
<p>When guidelines begin with a tacit acceptance that physicians have extensive relationships with industry, they can normalize the presence of industry in medicine, as well as the resulting conflicts of interest. </p>
<figure class="align-right ">
<img alt="A woman's hand holding a prescription bottle with a prescription pad in the background." src="https://images.theconversation.com/files/368049/original/file-20201106-17-v5r9ci.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/368049/original/file-20201106-17-v5r9ci.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/368049/original/file-20201106-17-v5r9ci.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/368049/original/file-20201106-17-v5r9ci.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/368049/original/file-20201106-17-v5r9ci.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/368049/original/file-20201106-17-v5r9ci.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/368049/original/file-20201106-17-v5r9ci.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">Doctors will often agree that their colleagues may be affected by industry relationships, but rarely acknowledge their own vulnerability.</span>
<span class="attribution"><span class="source">(Piqsels)</span></span>
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</figure>
<p>In a study of medical students, <a href="https://doi.org/10.1080/14461242.2016.1198713">Australian researchers</a> comment that professional codes of ethics “normalize certain behaviours and activities and inoculate the profession against loss of public trust and protect against more drastic interventions such as external review or regulation.”</p>
<p>Codes are central to the illusion that the incompatibility between public service and conflict of interest has been resolved. To counter such impressions, CMA’s guidelines must be framed with a strong acknowledgement that interactions with industry affect prescribing habits, and that physicians may not be aware that their <a href="https://doi.org/10.1016/s0002-9343(01)00660-x/">prescribing is affected</a>. </p>
<p>Doctors’ beliefs that their prescribing is unaffected by small gifts of food and drink has been put to rest. Research on payments to hundreds of thousands of doctors and their subsequent prescribing choices, made possible by the U.S. <a href="https://www.healthaffairs.org/do/10.1377/hpb20141002.272302/full/">Sunshine Act</a>, showed that even a <a href="https://doi.org/10.1001/jamainternmed.2016.2765">meal with a value of less than $20</a> affects prescribing in favour of the company supplying the meal.</p>
<p>Doctors will often agree that their colleagues may be affected but rarely acknowledge their own vulnerability. This vulnerability arises from the gift relationship. Doctors <a href="https://www.influenceatwork.com/principles-of-persuasion/">subconsciously feel obligated to repay the gifts</a> they receive from companies. Think seasonal greeting cards: If you got a card this year from someone you didn’t send one to, that person is likely to be at the top of your list for next year.</p>
<h2>‘Should’ vs. ‘must’</h2>
<p>Medical students and residents are particularly vulnerable and the guidelines need to deal with their situation. They can <a href="https://doi.org/10.1016/j.socscimed.2014.05.052">feel coerced by their superiors</a> into interacting with industry even when they feel ethically uncomfortable about doing so. </p>
<p>The guidelines should make it clear that physicians cannot require medical students or residents to attend any function sponsored by a pharmaceutical company. Further, if these types of activities occur, there must be avenues for students to confidentially report them with protection against reprisals.</p>
<p>The current version of the guidelines frequently uses the word “should” and this needs to be replaced with “must” to emphasize that there is a clear ethical imperative on the part of physicians to always put the interests of patients first. For example, the current version of the guidelines only says that “physicians should not accept personal gifts of any significant monetary or other value from industry.”</p>
<p>As we’ve noted above, these guidelines need to clearly state the types of interactions with industry that can and must be avoided in the interest of best patient care. But another fundamental problem is that they are voluntary. And the CMA should do much more to publicize the organization’s commitment to the principles behind them. </p>
<p>Dr. Woollard, the guiding force behind the guidelines, <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1485637/pdf/cmaj00272-0029.pdf">recognized this weakness</a>.</p>
<blockquote>
<p>“The greatest disappointment of the Canadian Medical Association process has been the lack of effective implementation at the level at which physicians work and interact with the pharmaceutical and health care supply industries.”</p>
</blockquote>
<p>The only hope the guidelines have of being effective is for the CMA to show the necessary leadership to make this issue an ongoing priority.</p><img src="https://counter.theconversation.com/content/149519/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2017-2020, Joel Lexchin received payments for being on a panel at the American Diabetes Association, for talks at the Toronto Reference Library, for writing a brief in an action for side effects of a drug for Michael F. Smith, Lawyer and a second brief on the role of promotion in generating prescriptions for Goodmans LLP and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p><p class="fine-print"><em><span>Barbara Mintzes receives research funding from Australia's National Health and Medical Research Council (NHMRC) and is co-principal investigator on a research project funded by the Canadian Institutes of Health Research (CIHR). She is an expert witness for Health Canada on a legal case concerning marketing of an unapproved drug. She is a member of a non-profit associations supporting access to essential medicines and public interests in pharmaceutical policy, Health Action International (HAI-Europe) and of Association Mieux Prescrire, a French non-profit association that produces an independent drug bulletin, La Revue Prescrire (English version: Prescrire International). </span></em></p><p class="fine-print"><em><span>Kelly Holloway has received funding from the Canadian Institutes of Health Research as a postdoctoral fellow.</span></em></p><p class="fine-print"><em><span>Marc-Andre Gagnon received funding from Justice Canada to serve as an Expert witness on the issue of drug pricing in Canada.</span></em></p>Patients have a stake in the relationship between doctors and pharmaceutical companies, so the CMA’s current review of its guidelines for doctor/pharma interactions is everybody’s business.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 TorontoBarbara Mintzes, Associate professor, School of Pharmacy and Charles Perkins Centre, University of SydneyKelly Holloway, Assistant Professor (Status), University of TorontoMarc-Andre Gagnon, Associate professor, School of Public Policy and Administration, Carleton UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1469352020-09-30T14:22:03Z2020-09-30T14:22:03ZCoronavirus: how the pharma industry is changing to produce a vaccine on time<figure><img src="https://images.theconversation.com/files/360781/original/file-20200930-16-btlt0z.jpg?ixlib=rb-1.1.0&rect=0%2C26%2C5955%2C2766&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">It normally takes ten years to produce a vaccine.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/hand-medical-staff-injecting-coronavirus-covid19-1726135243">Mongkolchon Akesin/Shutterstock</a></span></figcaption></figure><p>To bring COVID-19 under control a vaccine needs to be available to every nation, rich and poor – and it needs to happen quickly. But pharmaceutical breakthroughs are usually the result a slow process involving competition, secrecy, risky investments and extensive trials. </p>
<p>Changing any big industry to speed its processes up is going to be difficult. But there are signs that substantial changes are underway – and they may be here to stay.</p>
<p>Medical innovation is in fact often accelerated in a time of crisis. During the first world war, X-rays, developed two decades earlier, <a href="https://www.reseau-canope.fr/apocalypse-10destins/en/theme-based-files/progress-in-medicine-and-surgery-during-the-first-world-war.html">came into their own</a>. Logistical approaches to triaging and treating the wounded were also pioneered, and obligatory vaccinations for typhoid were introduced in the French army. </p>
<p>The second world war <a href="https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.acs.org%2Fcontent%2Facs%2Fen%2Feducation%2Fwhatischemistry%2Flandmarks%2Fflemingpenicillin.html&data=02%7C01%7C%7C5635c4ce946b4bb188c008d841bb3be1%7C1faf88fea9984c5b93c9210a11d9a5c2%7C0%7C0%7C637331619714156521&sdata=AsRUwGBtYsVNGL8kB50YaRLFeV6UbyTkP6F%2F3kGP2PY%3D&reserved=0">saw the first mass-scale production</a> of antibiotics. While the discovery was published in 1929, it was only in the late 1930s, with the looming prospect of war, that Oxford University began speeding up its work in this field. It was no small challenge to take a manually intensive laboratory process involving a mould grown on a solid surface and transform it into an industrially viable process, and all within five years. </p>
<p>The methods involved in this process also went on to form the foundation of the <a href="https://www.abc.net.au/science/features/biotech/1970.htm">biotechnology revolution</a> of the 1970s, which pioneered genetic engineering. </p>
<p>Making medicines is expensive, and it can take a very long time to get from the discovery of a drug to actually treating patients. With vaccines it’s a particular problem as the treatment needs to be administered to a huge number of healthy people. Add to this the high mutation rate of some viruses. The flu vaccine, for example, <a href="https://theconversation.com/a-universal-flu-vaccine-is-still-some-time-off-18525">is only effective for one season</a>. </p>
<p>It is difficult to introduce new technology to medicine. A major factor is regulation. It is critical that any medicine manufactured is safe and effective. The regulation of the biopharma sector is one of the strictest of any industry – the consequences of a mistake would be devastating. </p>
<p>If a medicine proves to be unsafe, not only does it put lives at risk but it can also <a href="https://theconversation.com/coronavirus-the-road-to-vaccine-roll-out-is-always-bumpy-as-20th-century-pandemics-show-145982">damage people’s confidence</a> in science and medicine more widely. The MMR vaccine, for example, <a href="https://www.nhs.uk/news/medication/no-link-between-mmr-and-autism-major-study-finds/">was once incorrectly associated with autism</a>, which caused lasting damage to people’s confidence in vaccination. </p>
<p>The majority of vaccines fail during development. Normally a ten-year timeframe <a href="https://www.weforum.org/agenda/2020/06/vaccine-development-barriers-coronavirus/">would be required</a> to bring a new vaccine to market. This is in large part due to developers and manufactures operating a risk-adverse business model, under which funding and facilities are committed sequentially on reaching defined milestones. For example, large-scale manufacture will not begin until the successful completion of clinical trials. </p>
<h2>New approaches</h2>
<p>The response to the COVID-19 pandemic has shown that it is <a href="https://theconversation.com/dont-hold-your-breath-for-a-covid-19-vaccine-in-2020-137441">possible to short-cut</a> this time frame if funding is committed (in the form of pre-purchase agreements), enabling manufacturers to take significant commercial risk by manufacturing products at a large scale before clinical trials have been completed and evaluated. This approach will enable significant stockpiles of new vaccines to be accumulated ready for use on approval. </p>
<figure class="align-center ">
<img alt="Picture of a woman holding a coronavirus vaccine and needle." src="https://images.theconversation.com/files/360783/original/file-20200930-24-zqbfyt.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/360783/original/file-20200930-24-zqbfyt.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=409&fit=crop&dpr=1 600w, https://images.theconversation.com/files/360783/original/file-20200930-24-zqbfyt.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=409&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/360783/original/file-20200930-24-zqbfyt.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=409&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/360783/original/file-20200930-24-zqbfyt.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=513&fit=crop&dpr=1 754w, https://images.theconversation.com/files/360783/original/file-20200930-24-zqbfyt.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=513&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/360783/original/file-20200930-24-zqbfyt.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=513&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A vaccine could be here soon.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/covid19-coronavirus-vaccine-doctor-scientist-syringe-1708463248">Sam Wordley/Shutterstock</a></span>
</figcaption>
</figure>
<p>The timeline can also be shortened by using new technologies for making vaccines. Traditionally, vaccines were made by <a href="https://www.chop.edu/centers-programs/vaccine-education-center/making-vaccines/how-are-vaccines-made">taking the pathogen itself</a> and then inactivating it, or by manufacturing a harmless close relative of the pathogen. These can then be inserted into the body. This involves complicated methods that have been in continual development for nearly 100 years, accelerating greatly during the second world war.</p>
<p>Clearly, either approach has risks, both for the patient and the manufacturer. For example, scientists may fail to inactivate the virus, or a harmless pathogen could mutate into a more potent form. The virus could also be accidentally released during production. </p>
<p><a href="https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.sciencedirect.com%2Ftopics%2Fbiochemistry-genetics-and-molecular-biology%2Frecombinant-dna-technology&data=02%7C01%7C%7C5635c4ce946b4bb188c008d841bb3be1%7C1faf88fea9984c5b93c9210a11d9a5c2%7C0%7C0%7C637331619714166516&sdata=sPBOwdePUmr6xDrrh9INhNiHuaECkAQxMKjQnw0hGLA%3D&reserved=0">Recombinant DNA technology</a>, joining together DNA molecules from different organisms and inserting them into a host, has become the workhorse for production of the most important classes of modern medicines: <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6988726/#:%7E:text=Therapeutic%20proteins%20can%20also%20be,interferons%2C%20interleukins%2C%20and%20thrombolytics">therapeutic proteins</a>. The same technology can be applied to vaccines by using <a href="https://onlinelibrary-wiley-com.libproxy.ucl.ac.uk/doi/full/10.1002/bit.25159">just part of a virus</a> – its structural proteins – and inserting it into the body. There, it acts as a vaccine by giving the immune system the opportunity to meet, recognise and prepare for the real virus. These types of vaccines are easier to scale up and safer than traditional ones.</p>
<p>Newer approaches that are currently being developed <a href="https://horizon-magazine.eu/article/five-things-you-need-know-about-mrna-vaccines.html">introduce only the genetic material</a> for the vaccine into the body, either directly or using another virus. This allows the cellular machinery to manufacture the viral protein, again enabling the immune system to prepare to fight off the actual virus. By their nature, these new approaches offer the advantage of increased development speed, but are still relatively unproven. Of the 34 COVID-19 vaccines <a href="https://www.nature.com/articles/d41573-020-00151-8">currently being evaluated</a> in clinical trials, 17 are of this type.</p>
<h2>Chances of success</h2>
<p>The ambitious timelines for a COVID vaccine would be far outside anything previously achieved. There are reasons to be optimistic. While most vaccines fail during development, there are more than 230 candidate vaccines for COVID-19 in development. But many of the technologies being pursued are new and unproven, so investing in them is a risk. </p>
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Read more:
<a href="https://theconversation.com/oxford-scientists-these-are-final-steps-were-taking-to-get-our-coronavirus-vaccine-approved-144623">Oxford scientists: these are final steps we're taking to get our coronavirus vaccine approved</a>
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<p>Importantly, the biotech industry, faced with major international health challenges, has a long history of collaboration. And there is evidence that, to meet the urgency of the global COVID-19 crisis, competition is reducing. Collaboration on technologies, <a href="https://news.bloomberglaw.com/pharma-and-life-sciences/pharma-collaborations-in-the-covid-19-era-come-with-legal-risks">between companies</a> and <a href="https://www.frontiersin.org/articles/10.3389/fphar.2020.00937/full">between commercial, academic and regulatory partners</a> is accelerating. </p>
<p>Manufacturers can also rely on initiatives that existed even before the pandemic, such as the University College London’s <a href="https://www.ucl.ac.uk/biochemical-engineering/research/research-and-training-centres/vax-hub">Vax Hub</a> working to produce affordable vaccines by collaborating with Oxford University as well as the company AstraZenaca.</p>
<p>As the the two world wars have shown, biomedical innovation can be speeded up at a time of crisis. And if we are really lucky, some processes and initiatives involved in the production of a COVID-19 vaccine may be here to stay – benefiting people for decades to come.</p><img src="https://counter.theconversation.com/content/146935/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>Medical innovation is often accelerated in a time of crisis.Beatrice Melinek, Post-doctoral Research Fellow of Biochemical Engineering, UCLStephen Morris, Research Fellow in Vaccine Process Analytics, UCLLicensed as Creative Commons – attribution, no derivatives.