tag:theconversation.com,2011:/au/topics/health-canada-43785/articlesHealth Canada – The Conversation2023-11-28T20:10:03Ztag:theconversation.com,2011:article/2173092023-11-28T20:10:03Z2023-11-28T20:10:03ZStriving for transparency: Why Canada’s pesticide regulations need an overhaul<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/striving-for-transparency-why-canadas-pesticide-regulations-need-an-overhaul" width="100%" height="400"></iframe>
<p><a href="https://www.canada.ca/en/health-canada/news/2021/08/government-of-canada-pauses-decision-on-glyphosate-as-it-strengthens-the-capacity-and-transparency-of-review-process-for-pesticides.html">In 2021, Health Canada announced a freeze on changing maximum residue limits (MRLs)</a> — the maximum allowable pesticide residues acceptable under Canadian law. This decision followed substantial public outcry following Canada’s most widely used weed killer <a href="https://www.canada.ca/en/health-canada/services/consumer-product-safety/pesticides-pest-management/public/consultations/proposed-maximum-residue-limit/2021/glyphosate/document.html">glyphosate’s proposed MRL increase.</a></p>
<p>This year, three ministries (including Health Canada) <a href="https://www.canada.ca/en/health-canada/news/2023/06/government-of-canada-moves-forward-on-federal-pesticide-commitments.html">unpaused</a> the comparatively less complex residue limit adjustments and <a href="https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/pest-management-regulatory-agency/transforming/how-we-are-transforming.html">sought to transform</a> the <a href="https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/pest-management-regulatory-agency.html">Pest Management Regulatory Agency (PMRA)</a>. </p>
<p>The move was aimed to enhance transparency, modernize their business practices, improve access to information related to pesticide decision-making, and increase the use of real world data and independent advice. </p>
<p>However, trust in the agency remains an issue; only <a href="https://publications.gc.ca/collections/collection_2023/sc-hc/H114-39-2023-eng.pdf">60 per cent of Canadians believe the regulatory system is keeping pace with scientific advancements in pesticide assessment,</a> adding further pressure to Canadian’s eroding trust in science.</p>
<h2>Challenges and controversies</h2>
<p>In spite of ongoing concerns over risks to human and environmental health, global pesticide use has been <a href="https://www.fao.org/faostat/en/#data/RP/visualize">increasing over the past 30 years</a>. </p>
<p>In Canada, increased reliance on pesticides has been largely tied to the intensity of agricultural use in the main crop growing regions of <a href="https://doi.org/10.3389/fenvs.2020.556452">the Canadian Prairies, Southern Ontario and Québec.</a></p>
<p>Advancing pesticide regulation to meet the needs of Canada’s agricultural sector, while protecting human and environmental health, is a growing challenge. </p>
<p>There are <a href="https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/pesticides-pest-management/corporate-plans-reports/annual-report-2020-2021.html">more than 600 registered active ingredients in more than 7,600 registered pesticide products</a> — a staggering number that continues to rise. </p>
<p>From 2011 to 2021, the PMRA registered between seven and 27 new active pesticide ingredients each year. Meanwhile, it has only <a href="https://doi.org/10.3390/toxics11020121">banned 32 of 531 prohibited active pesticide ingredients regulated in 168 other countries</a>.</p>
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<p>This influx puts added pressure on the agency to review volumes of scientific data produced by both the registrant and independent scientists, while continuously assessing the growing list of existing products for their safety to humans and risks to environmental health. </p>
<p>Some chemical registration decisions, including <a href="https://beyondpesticides.org/dailynewsblog/2016/01/canada-discontinues-conditional-registrations-for-new-pesticides/">conditional registrations</a>, have been highly controversial, highlighting the lack of transparency or perceived industry bias. </p>
<p>In the case of glyphosate, sales in Canada have topped nearly 470 million kilograms from 2007 to 2018. Public concerns over human health risks and regulated uses have led to <a href="https://www.ctvnews.ca/health/advocates-thrilled-as-court-orders-health-canada-to-reassess-glyphosate-decision-1.5772134">legal challenges</a>. </p>
<p>Similarly, the proposed 2018 decision to phase out three of the most widely used, environmentally persistent and toxic neuro-active <a href="https://www.canada.ca/en/health-canada/services/consumer-product-safety/pesticides-pest-management/growers-commercial-users/neonicotinoid-insecticides.html">neonicotinoid insecticides</a> was later <a href="https://www.nationalobserver.com/2021/04/08/news/feds-wont-ban-pesticides-deadly-bees-bugs-ecosystems">reversed in 2021</a>. Citizens and scientists were left seeking answers on whether industry influence caused the <a href="https://www.wildernesscommittee.org/news/federal-pesticide-regulator-flip-flops-proposed-neonics-ban-after-years-delay">flip-flop</a>.</p>
<h2>Evolving roles</h2>
<p>Last year, as part of the transformation agenda, Health Canada aimed to fortify its pesticide review processes by establishing an <a href="https://www.canada.ca/en/health-canada/corporate/about-health-canada/public-engagement/external-advisory-bodies/science-advisory-committee-pest-control-products.html">independent Science Advisory Committee</a>. </p>
<p>Currently comprising eight academic experts, whose backgrounds were screened for conflict of interest, the committee has been tasked to provide objective, science-based advice to inform regulatory decisions on pest control products. We are four of them.</p>
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<figcaption><span class="caption">An exploration into the connections between pesticide use and disease in humans, produced by Deutsche Welle documentaries.</span></figcaption>
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<p>Since its creation in July 2022, the committee has met five times with Health Canada’s PMRA in a <a href="https://www.canada.ca/en/health-canada/corporate/about-health-canada/public-engagement/external-advisory-bodies/science-advisory-committee-pest-control-products/meetings.html">public forum</a>.</p>
<p>The committee has been tasked with providing input on diverse issues such as communication of MRLs, use of independent data sources, creation of open source toxicity databases, and access to registrant data used in decision-making. </p>
<p>As a positive early sign, the PMRA has been responsive to the <a href="https://www.canada.ca/en/health-canada/corporate/about-health-canada/public-engagement/external-advisory-bodies/science-advisory-committee-pest-control-products/advisory-reports.html">committee’s advice and recommendations</a>, which is anticipated to reinforce public trust and ensure science-based decision-making is at the core of its processes. </p>
<h2>Informing new policies</h2>
<p>Canada is long overdue in establishing a <a href="https://canadacommons.ca/artifacts/1191021/a-canada-wide-framework-for-water-quality-monitoring/1744148/">co-ordinated water monitoring program</a> to systematically measure pesticide levels nationally. </p>
<p>The committee is providing external scientific advice on the new pilot <a href="https://www.canada.ca/en/health-canada/services/consumer-product-safety/pesticides-pest-management/public/protecting-your-health-environment/programs-initiatives/water-monitoring-pesticides/pilot-program.html">Water Monitoring Framework Initiative</a>. </p>
<p>Committee experts are giving input on guidance for site selection, monitoring frequency in different types of surface waters and analytical measurement of current use compounds and their degradation products. </p>
<p>The goal is to ensure this much-needed water quality data is rigorous and usable for future risk assessment and independent scientific research.</p>
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<p>Recently, the PMRA has an added responsibility to enhance broader Canadian biodiversity goals and environmental protections by aligning its regulatory work with the <a href="https://www.cbd.int/article/cop15-final-text-kunming-montreal-gbf-221222">2022 Kunming-Montreal Global Biodiversity Framework — aiming to reduce pesticide risk by at least 50 per cent by 2030</a> — alongside the enactment of <a href="https://www.canada.ca/en/environment-climate-change/news/2023/06/bill-s-5-strengthening-environmental-protection-for-a-healthier-canada-act.html">Bill S-5, updating the Canadian Environmental Protection Act of 1999</a>, to consider cumulative pesticide exposure in risk assessments. The committee is currently developing recommendations to inform approaches to best address these significant policy initiatives.</p>
<h2>Towards a pesticide-safe Canada</h2>
<p>The journey to more transparent and scientifically robust pesticide regulation in Canada is long overdue, yet essential. </p>
<p>A greater emphasis on transparency and communication of the science that underpins regulatory decision-making is urgently needed. A lack of access to data and information used in risk assessment undermines the public trust. </p>
<p>An over-reliance on industry supplied confidential studies, limited application of data from independent scientists, a lack of publicly available data on active ingredient pesticide sales, use and environmental monitoring, are all contributing to scepticism. </p>
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<p>As the PMRA transitions to more transparency and reaffirms its evidence-based decision-making for pesticide regulation, insight from independent scientific researchers as part of the committee will play a critical role.</p><img src="https://counter.theconversation.com/content/217309/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Valérie S. Langlois is receiving funding from the Canada Research Chair (CRC) program, the Natural Sciences and Engineering Research Council of Canada (NSERC), Environment and Climate Change Canada (ECCC), the Ministère de l'environnement et de la lutte contre les changements climatiques, Faune et Parcs du Québec (MELCCFP), among others. Dr. Langlois is the co-chair of the Science Advisory Committee (SAC).</span></em></p><p class="fine-print"><em><span>Christy Morrissey currently receives funding from Canada's Natural Sciences and Engineering Research Council, Canada Foundation for Innovation, Environment and Climate Change Canada, Mitacs, Saskatchewan Ministry of Agriculture, and the Molson Foundation. She is a member of the PMRA's Science Advisory Committee (SAC).</span></em></p><p class="fine-print"><em><span>Dr. Eric Liberda receives funding from CIHR and Indigenous Services Canada to conduct research related to pesticides and metal/metalloid exposures. He is a member of the Society of Toxicology and the Society of Toxicology Canada. Dr. Liberda is a co-chair of the Science Advisory Committee (SAC).</span></em></p><p class="fine-print"><em><span>Sean Prager receives funding from NSERC, Canadian Foundation for Innovation, Genome Canada, The Saskatchewan Ministry of Agriculture, several commodity boards and NGOs. He is affiliated with the PMRA Science Advisory Committee (SAC). </span></em></p>Canada is long-overdue for scientifically-driven, robust and transparent pesticide regulation. A newly created Science Advisory Committee aims to address this.Valérie S. Langlois, Professor/Professeure titulaire, Institut national de la recherche scientifique (INRS)Christy Morrissey, Professor in Biology and Ecotoxicology, Toxicology Centre, University of SaskatchewanEric Liberda, Professor, School of Occupational and Public Health, Toronto Metropolitan UniversitySean Prager, Associate Professor and Entomologist, University of SaskatchewanLicensed 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/2047872023-05-04T20:39:52Z2023-05-04T20:39:52ZHealth Canada should be transparent about how it’s monitoring drug safety<figure><img src="https://images.theconversation.com/files/524019/original/file-20230503-26-zdm4om.jpg?ixlib=rb-1.1.0&rect=586%2C439%2C5165%2C3388&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">When regulatory agencies like Health Canada approve a new drug, they require the drug company to continue monitoring the product's safety.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><iframe style="width: 100%; height: 100px; border: none; position: relative; z-index: 1;" allowtransparency="" allow="clipboard-read; clipboard-write" src="https://narrations.ad-auris.com/widget/the-conversation-canada/health-canada-should-be-transparent-about-how-it-s-monitoring-drug-safety" width="100%" height="400"></iframe>
<p>Regulatory bodies like Health Canada are intended to ensure that approved drugs go through a rigorous multi-stage process. However, clinical trials can’t detect every side-effect or risk. </p>
<p>Once new drugs are approved for marketing in Canada, Health Canada continues to monitor them. This is to determine if the health benefits identified in pre-market trials hold up to further scrutiny, new safety issues arise or known ones are more serious than initially anticipated, and if the drugs are being used outside of their approved uses and populations. </p>
<p>All of that information is important for doctors and pharmacists and for people who will be using the drugs and should be publicly available.</p>
<h2>Clinical trials</h2>
<p>Potential new drugs are assessed in <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/guidance-documents/guidance-drugs-clinical-trials-human-subjects-gui-0100.html">clinical trials</a> before they can be authorized for sale in Canada. But in order to make it easier to clearly identify if the drugs are beneficial, these trials only enrol a very selective group of patients. </p>
<p>For example, people who are accepted into these trials need to have a definite diagnosis, they should only be suffering from the disease the drug is intended to treat, they shouldn’t be taking other drugs, they may have to live near the site where the testing is ongoing — and the exclusions go on. </p>
<p>By one estimate, <a href="https://doi.org/10.1176/appi.ajp.159.3.469">out of a potential 346 patients only 29</a> or fewer than 10 per cent, qualified for a trial looking at treating major depression. In addition, <a href="https://deainfo.nci.nih.gov/advisory/ctac/archive/0309/presentations/Williams_030409.pdf">clinical trials often leave out</a> children, the elderly, women, minority groups, people with disabilities and multiple other groups.</p>
<p>Usually <a href="https://www.healthline.com/health/clinical-trial-phases#phase-ii">only 3,000 to 5,000 people</a> are exposed to an experimental drug in clinical trials. The much larger trials conducted for the COVID-19 vaccines, <a href="https://www.nih.gov/news-events/news-releases/peer-reviewed-report-moderna-covid-19-vaccine-publishes">involving 30,000</a> to <a href="https://www.pfizer.com/science/coronavirus/vaccine/about-our-landmark-trial">46,000 people</a>, were an exception to this. </p>
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<img alt="White pills spilling out of a bottle forming the shape of a question mark against a pink background" src="https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/524020/original/file-20230503-444-eml4cj.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">When drugs are finally approved, there are still unanswered safety questions, including about how drugs will affect demographic groups who were left out of the trials.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
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<p>Previous research has shown that in order to detect rare side-effects, a trial needs to use the <a href="https://blogs.bmj.com/bmjebmspotlight/2017/11/14/rare-adverse-events-clinical-trials-understanding-rule-three/">statistical rule of three</a>: For example, if a side-effect affects one in 1,000 patients, a trial would have to enrol at least 3,000 people (three x 1,000) to have a 95 per cent chance of seeing even a single case. This means that rare safety issues may be missed entirely. </p>
<p>The result is that when drugs are finally approved, there are still unanswered safety questions, including about how drugs will affect demographic groups who were left out of the trials.</p>
<h2>Drug safety programs</h2>
<p>That’s why when regulatory agencies like Health Canada approve a drug, they require the drug company to monitor post-market safety. These programs go by various names; in <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-document-submission-risk-management-plans-follow-commitments.html">Canada</a> and <a href="https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pharmacovigilance/risk-management/risk-management-plans">Europe</a> they are Risk Management Plans (RMP) and in the United States they are <a href="https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems">Risk Evaluation and Mitigation Strategies</a> (REM). </p>
<p>Canada’s current RMP system has been in place <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-document-submission-risk-management-plans-follow-commitments.html">since 2009</a>. According to <a href="https://www.canada.ca/en/health-canada/programs/consultation-proposed-agile-regulations-guidance-licensing-drugs-medical-devices/submitting-risk-management-plans.html">Health Canada documents</a>, RMPs are mandatory when there is a significant degree of uncertainty respecting the risks associated with a particular drug or when a drug “presents a serious risk of injury to human health that warrants measures … to reduce the probability or severity of such an injury.”</p>
<p>All new drugs that have never before been sold in Canada in any form, as well as all opioids, require RMPs to help safeguard the public. </p>
<p><a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/profile-guidance-document-submission-risk-management-plans-follow-commitments/notice-clarification-drug-manufacturers-sponsors.html">Under these plans</a> companies may have to conduct additional safety studies, set up registries to identify patients who are taking the drug, develop educational materials for health care professionals and/or patients, restrict access to the drug and commit to undertaking a number of other measures.</p>
<p>RMPs are not perfect and won’t resolve all the safety uncertainties about new drugs. <a href="https://doi.org/10.1038/clpt.2014.184">One European study</a> estimated that after five years, only about one in five issues was settled. More definitely needs to be done to monitor post-market safety. </p>
<p>But RMPs are still a significant tool. Issues that remained unresolved in some cases were whether theoretical risks were actually seen in practice and whether there was enough information to determine if long-term data revealed new safety concerns.</p>
<h2>Access to drug monitoring information</h2>
<p>Doctors who prescribe drugs, pharmacists who fill prescriptions, researchers who study drug safety and especially patients who take the drugs all should have a right to know how safety is being monitored. </p>
<p>In the U.S., people can turn to a <a href="https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm">Food and Drug Administration website</a> that lists all the drugs with REMS. There they can read about the goals of the REMS, a summary of the measures included in it, look at the materials that have been developed and how the effectiveness of the REMS plan is going to be assessed. </p>
<p>In European countries like <a href="https://laegemiddelstyrelsen.dk/en/licensing/licensing-of-medicines/medicines-authorised-with-a-summary-of-the-risk-management-plan/">Denmark there is a similar list of drugs</a> with a RMP. Click on a hyperlink and it takes you to a summary of the RMP for the drug in question.</p>
<p>Health Canada currently has no such website, and acknowledges that <a href="https://nlpb.ca/media/Health-Canada_QA-for-HCP_RMP_EN_Updated_2022-07-07.pdf">this is an information gap</a>. Two of <a href="https://www.canada.ca/en/health-canada/programs/consultation-proposed-agile-regulations-guidance-licensing-drugs-medical-devices/submitting-risk-management-plans.html">Health Canada’s stated goals</a> in implementing a system of RMPs are to “support Canadians’ timely access to safe, efficacious and high quality drugs and support ongoing evaluation of information that could have an impact on the benefit-risk profile of health products.” </p>
<p>But without access to current information on specific drugs, Canadians cannot assess those risks for themselves, nor can they evaluate the monitoring program. </p>
<p>On top of this lack of transparency, <a href="https://shpm.info.yorku.ca/files/2020/09/Health-Canada-funding-distribution-2004-2020.pdf">Health Canada spends only one-third as much money and has only one-third as many employees</a> monitoring drug safety compared to the amount of money and the number of people who are involved in approving new drugs.</p>
<p>Since February 2019, Health Canada has been a world leader in <a href="https://www.bmj.com/content/365/bmj.l1825">releasing the information that it used in deciding to approve new drugs</a>. It has a <a href="https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review.html?_ga=2.233746589.2014837886.1506726303-1326787507.1398655537#_Submissions_currently_under">website</a> that lists drugs that weren’t approved and what drugs it’s considering for approval. There is a <a href="https://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=B68C1BAF-1">website with RMPs for substances that are harmful</a> to the environment and human health, albeit with data from 2016. </p>
<p>It’s time for Health Canada to do the same for drug RMPs. <a href="https://canadagazette.gc.ca/rp-pr/p1/2022/2022-12-17/html/reg1-eng.html">When Canada’s Food and Drugs Act regulations are amended</a>, transparency for drug RMPs needs to be made mandatory. But Health Canada does not need to wait until then to make this information available to Canadians.</p><img src="https://counter.theconversation.com/content/204787/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2019-2022, Joel Lexchin received payments for writing briefs on the role of promotion in generating prescriptions for two legal firms. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p>Health Canada continues to monitor newly approved drugs to determine if the benefits identified in the pre-market trials hold up to further scrutiny. Canadians need better access to that information.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, CanadaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/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/1740872021-12-22T16:58:22Z2021-12-22T16:58:22ZGeneric drug names provide information for doctors, so why is Health Canada promoting the use of pharma brand names?<figure><img src="https://images.theconversation.com/files/438724/original/file-20211221-49721-1iiafqu.jpg?ixlib=rb-1.1.0&rect=143%2C53%2C5838%2C3260&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Generic drug names are assigned at the global level by the World Health Organization in conjunction with national naming authorities.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><iframe style="width: 100%; height: 175px; border: none; position: relative; z-index: 1;" allowtransparency="" src="https://narrations.ad-auris.com/widget/the-conversation-canada/generic-drug-names-provide-information-for-doctors--so-why-is-health-canada-promoting-the-use-of-pharma-brand-names" width="100%" height="400"></iframe>
<p>Brand names are widely used when we want to refer to a specific product — an Apple computer, a Tesla car. Sometimes brand names are so widely used that they take over — we ask for a Kleenex instead of a tissue.</p>
<p>Drugs have two names. The brand name is the one that’s chosen by the company making it and that company is the only one allowed to use the name. (The name that the company proposes is <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/frequently-asked-questions-guidance-document-industry-review-drug-brand-names.html">reviewed by Health Canada</a>.) Brand names are almost always short and catchy so that doctors will remember them. </p>
<p>Generic names are assigned at the global level by the <a href="https://www.ismp.org/resources/are-national-efforts-reduce-drug-name-confusion-paying">World Health Organization in conjunction with national naming authorities</a>. These names are often long, but part of the reason for the length is that they tell doctors about the pharmacologic property and/or chemical structure of the medication.</p>
<p>The generic name for the new <a href="https://www.npr.org/sections/health-shots/2019/05/24/725404168/at-2-125-million-new-gene-therapy-is-the-most-expensive-drug-ever">US$2-million-per-patient drug for spinal muscular atrophy</a> is onasemnogene abeparvovec. The brand name is Zolgensma. Which one are doctors (and patients) going to remember and use? The answer is obvious. </p>
<p>One of the <a href="https://dx.doi.org/10.1503%2Fcmaj.112160">associate editors at the Canadian Medical Association Journal</a> makes the point that “some brand names are created to be reassuring or promising — so-called ‘benefit-led’ names such as Paxil, Celebrex and Gluconorm — when they actually need to be prescribed with great care and consideration of the drug’s potential effects on the individual patient.”</p>
<figure class="align-center ">
<img alt="Prescription bottles and white tablets on a white background" src="https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/438725/original/file-20211221-50268-1dtvkss.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Some pharmaceutical brand names are meant to sound reassuring or promising.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Is the use of brand names the right way to talk about prescription drugs? Apparently, Health Canada thinks so. Want information about safety problems with a medicine? On Canada’s recall site, you’ll see the <a href="https://recalls-rappels.canada.ca/en/search/site?search_api_fulltext=Daclizumab">brand name in CAPITALS</a> and the generic name in lower case and in brackets. </p>
<p>Want to see if there is a shortage of the drug that your doctor just wrote you a prescription for? Go to <a href="https://www.drugshortagescanada.ca/">Drug Shortages Canada</a> and you’ll find the brand names of the drugs, again in capitals. </p>
<p>If you’re interested in why Health Canada approved a particular drug, the <a href="https://hpr-rps.hres.ca/reg-content/summary-basis-decision-result.php?lang=en&term=">Summary Basis of Approval document</a> will help you understand. But once more the brand name is the most prominent one, and again it’s in capitals.</p>
<h2>What’s in a name?</h2>
<p>In medical school, students are taught to use generic names. <a href="http://www.icmje.org/recommendations/browse/manuscript-preparation/preparing-for-submission.html">Medical journals</a> tell authors to use generic names in the articles that they write. Does it matter which name doctors use? The answer is yes.</p>
<p>When <a href="https://doi.org/10.1177/0310057x0903700401">Australian anaesthetists and doctors training to be anaesthetists in two teaching hospitals</a> were given the brand names of drugs, they could only correctly identify the therapeutic group that the drug came from in just over half the cases. Without knowing what therapeutic group the drug came from, doctors could accidentally have used another drug from the same group or they could have used the drug incorrectly.</p>
<figure class="align-right ">
<img alt="Illustration of a pharma rep shaking hands with a doctor" src="https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/438732/original/file-20211221-167342-k9z3mu.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=754&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Seeing drug company sales representatives more frequently is associated with more brand name prescribing, which translates into more expensive prescribing. Sales reps also usually leave out important safety information.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>The <a href="https://dx.doi.org/10.1002%2Fpds.4224">more money that doctors receive from drug companies</a> in the form of meals, travel arrangements and ownership royalties, the less likely they were to prescribe by generic name. Seeing <a href="https://www.cmu.edu/news/stories/archives/2017/may/marketing-and-prescribing-behavior.html">drug company sales representatives more frequently</a> is associated with more brand name prescribing, which translates into more expensive prescribing. Sales reps also usually <a href="https://doi.org/10.1007/s11606-013-2411-7">leave out important safety information</a> about drugs they are promoting, so besides prescriptions costing more, they might also be more likely to harm patients.</p>
<p>Brand names, drug regulation (the domain of Health Canada) and pharmaceutical promotion have come together in a particularly egregious way in the case of buprenorphine-naloxone, brand name Suboxone — an opioid medication used to treat opioid addiction. </p>
<p>Even though generic formulations of the drug have been available in Canada since 2013 (and even earlier in the United States), the drug is widely referred to by its brand name, including <a href="https://www.theglobeandmail.com/canada/article-the-timmins-tag-team-when-opioids-and-official-inaction-were-killing/">in the media</a>, <a href="https://news.ontario.ca/en/backgrounder/47406/taking-action-to-prevent-opioid-addiction-and-overdose">by policy makers</a> and by doctors. </p>
<h2>Branded education</h2>
<p>One way this happened was through the promotion of an “educational” program developed and delivered by Indivior, the company that holds the rights to Suboxone. In some provinces, completing this branded program is <a href="https://crism.ca/wp-content/uploads/2018/03/CRISM_NationalGuideline_OUD-ENG.pdf">a pre-requisite to being able to prescribe buprenorphine-naloxone</a>. The same strategy has been executed for a related injectable form of buprenorphine, also owned by Indivior. </p>
<p>This use of the branded program is the case even though there are perfectly <a href="https://www.camh.ca/en/education/continuing-education-programs-and-courses/continuing-education-directory/opioid-use-disorder-treatment-course">good, accredited, non-industry educational programs</a> already available to teach appropriate opioid addiction care and prescribing to doctors, nurses and pharmacists. </p>
<p>The inclusion of the brand name in the title of this program flies in the face of <a href="https://policybase.cma.ca/documents/PolicyPDF/PD21-20.pdf">recommended practices</a> and <a href="https://www.cfpc.ca/CFPC/media/PDF/Understanding-Mainpro-Certification-English-April15-2021.pdf">accreditation standards</a> for Canadian medical education programs.</p>
<p>Yet, the branded program is fully sanctioned by Health Canada through that body’s review and approval of the <a href="https://pdf.hres.ca/dpd_pm/00063411.PDF">Suboxone product monograph</a>. This document, which describes the nature of the drug and its approved uses in Canada, includes a description of the requirement for participation in the branded “training program.” </p>
<p><a href="http://doi.org/10.1056/NEJMp1906680">As has been documented in the U.S.</a>, Indivior and its parent company Reckitt Benckiser have engaged in a variety of unscrupulous practices to promote their multibillion-dollar buprenorphine product line — ultimately paying <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/indivior-solutions-sentenced-part-2-billion-resolution-false-safety-claims-concerning-suboxone">some of the largest fines in U.S. pharmaceutical history</a>. In this light, a branded “educational” program seems to be one more vehicle for brand name promotion, and one in which Health Canada is directly complicit.</p>
<p>When doctors use brand names they may be less knowledgeable about the drugs they are prescribing, their prescriptions cost more and patients may be more likely to suffer side-effects. When Health Canada prioritizes brand names over generic names it is actively contributing to all these problems.</p>
<p>Health Canada should know better and must do better.</p><img src="https://counter.theconversation.com/content/174087/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2018-2021, Joel Lexchin received payments for writing a brief in an action for side effects of a drug for Michael F. Smith, Lawyer and a second brief on the role of promotion in generating prescriptions for Goodmans LLP and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is a member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p><p class="fine-print"><em><span>Abhimanyu Sud has received funding from or consulted with the Canadian Institutes of Health Research, Health Canada, Association of Faculties of Medicine of Canada, University of Toronto, Centre for Effective Practice, and Mississauga-Halton Local Health Integration Network for research and medical education relating to opioid use and drug policy.</span></em></p>Generic drug names are often long, but they can tell doctors what type of medicine it is and how it works. But it’s brand names that appear first and most prominently in Health Canada materials.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, Emergency Physician at University Health Network, Associate Professor of Family and Community Medicine, University of TorontoAbhimanyu Sud, Assistant Professor, Department of Family and Community Medicine, University of TorontoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1728352021-11-30T22:03:02Z2021-11-30T22:03:02ZDrug companies protest when Health Canada withdraws their products for safety reasons<figure><img src="https://images.theconversation.com/files/434537/original/file-20211129-23-3yrz9a.jpg?ixlib=rb-1.1.0&rect=2%2C31%2C1914%2C1244&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The level of evidence for withdrawing a drug does not appear to affect the pharma company's response.</span> <span class="attribution"><span class="source">(Pixabay)</span></span></figcaption></figure><p>For decades oil companies denied that their products were <a href="https://www.theguardian.com/environment/2021/mar/18/oil-industry-fossil-fuels-air-pollution-documents">harmful to human health</a>. <a href="https://theintercept.com/2021/06/30/epa-pesticides-exposure-opp/">Pesticide companies</a> did the same with their products. We all know how executives from <a href="https://truthinitiative.org/research-resources/tobacco-prevention-efforts/5-ways-tobacco-companies-lied-about-dangers-smoking">cigarette companies lied about the harms from smoking</a>.</p>
<p>Are drug companies any different? When drugs are taken off the market because they are either unsafe or don’t work, do companies admit that there are problems? There is certainly some evidence that companies deny the evidence.</p>
<p>Researchers in the United States <a href="https://doi.org/10.1056/NEJMoa072761">published a meta-analysis</a> in the <em>New England Journal of Medicine</em> (<em>NEJM</em>) in 2007 showing an association between the diabetes drug rosiglitazone and a significant increase in the risk of a heart attack. The <a href="https://www.natap.org/2007/HIV/052107_03.htm">response from GlaxoSmithKline</a>, the maker of the drug, was that the company “strongly disagrees with the conclusions reached in the <em>NEJM</em> article, which are based on incomplete evidence and a methodology that the author admits has significant limitations.” </p>
<p>In another case, a 2001 <a href="https://doi.org/10.1001/jama.286.8.954">article in <em>JAMA: The Journal of the American Medical Association</em></a> raised “a cautionary flag about the risk of cardiovascular events with COX-2 inhibitors,” a type of non-steroidal anti-inflammatory drug used to treat pain and inflammation. Merck was the company selling one of these drugs and an <a href="https://doi.org/10.1001/jama.286.22.2808">employee of Merck Research Laboratories and a Merck consultant</a> claimed that “the analysis provides no substantial support for their conclusion.”</p>
<p>But these might have been isolated examples. In a <a href="https://doi.org/10.3233/JRS-210013">recently published article</a>, I set out to answer the question in a systematic manner.</p>
<h2>Withdrawn drugs</h2>
<p>As a first step, I compiled a list of all the drugs that Health Canada had pulled from the shelves since 1990 either because they had serious safety problems or because they didn’t work. Putting that list together was not easy because of the way that Health Canada organizes information. I had to go through thousands of safety notices and warnings since 2000 on <a href="https://recalls-rappels.canada.ca/en/search/site?f%5B0%5D=audience%3A216&f%5B1%5D=category%3A180">Health Canada’s website</a>, and then combined what I found with the information in an <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4085091/">article that I published in 2014</a>. </p>
<p>In the end, I had the names of 31 drugs. Then I looked for either press releases from the companies about those drugs or articles containing direct quotations or paraphrases of company statements, and found material about 22 drugs.</p>
<p>Almost half the time (10 of 22 drugs), the companies disagreed with the decision to withdraw the drug from the market, and in just under one-third (seven of 22 cases) they agreed with the decision. In the other five cases they felt that the drug could have been kept on the market with restrictions or said that they might reintroduce the drug.</p>
<figure class="align-center ">
<img alt="Exterior shot of office building housing Bayer Healthcare's North American headquarters in Whippany, N.J." src="https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/434841/original/file-20211130-22-1igk79q.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Bayer had no objections when Health Canada withdrew the company’s cholesterol drug from the market in 2001.</span>
<span class="attribution"><span class="source">(AP Photo/Julio Cortez)</span></span>
</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/1698202021-11-01T16:26:59Z2021-11-01T16:26:59ZEthical decisions: Weighing risks and benefits of approving COVID-19 vaccination in children ages 5-11<figure><img src="https://images.theconversation.com/files/429411/original/file-20211029-23-1u7vp0d.jpg?ixlib=rb-1.1.0&rect=257%2C74%2C4082%2C2809&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Ethics are important to vaccination decisions because while science can clarify some of the costs and benefits, it cannot tell us which costs and benefits matter most to us.</span> <span class="attribution"><span class="source">THE CANADIAN PRESS/Frank Gunn </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/ethical-decisions--weighing-risks-and-benefits-of-approving-covid-19-vaccination-in-children-ages-5-11" width="100%" height="400"></iframe>
<p>The U.S. Food and Drug Administration has approved <a href="https://www.cbc.ca/news/world/fda-approves-pfizer-children-1.6229798">Pfizer’s COVID-19 vaccine for use in children ages five to 11</a>. Pfizer’s <a href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results">clinical trial results</a> indicate the vaccine is safe and effective in this age group. </p>
<p>This is an important development. <a href="https://globalnews.ca/news/8250271/covid-19-bc-modelling-data-children/">COVID-19 infections</a> <a href="https://www.cbc.ca/news/canada/calgary/covid-alberta-kids-1.6208827">are on the rise</a> <a href="https://www.cbc.ca/news/canada/saskatchewan/covid-19-saskatchewan-october-9-1.6206509">in children</a> <a href="https://www.thestar.com/politics/provincial/2021/09/28/ontarios-new-covid-19-cases-could-drop-to-200-a-day-or-rise-to-5000-latest-modelling-projects.html">across</a> <a href="https://www.cbc.ca/news/canada/new-brunswick/new-brunswick-school-covid-19-1.6202893">Canada</a>.</p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=600&fit=crop&dpr=1 600w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=600&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=600&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=754&fit=crop&dpr=1 754w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=754&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/410911/original/file-20210712-19-geybnm.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=754&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption"></span>
<span class="attribution"><a class="source" href="https://theconversation.com/ca/topics/vaccine-confidence-in-canada-107061">Click here for more articles in our series about vaccine confidence.</a></span>
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</figure>
<p>It is now up to <a href="https://www.cbc.ca/news/health/pfizer-seeks-kids-covid-vaccine-approval-health-canada-1.6215547">Health Canada</a> to consider the data and to decide whether to authorize this COVID-19 vaccine for children. Once it is authorized in Canada, the <a href="https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci.html">National Advisory Committee on Immunization</a> (NACI) will have to decide whether to recommend vaccination for all children in this age group. </p>
<p>This raises the question of how this decision ought to be made.</p>
<h2>Making an ethical decision</h2>
<p>As a moral philosopher who has <a href="http://blog.practicalethics.ox.ac.uk/2021/08/we-should-vaccinate-children-in-high-income-countries-against-covid-19-too/">collaboratively researched</a> <a href="https://doi.org/10.1136/bmj.n1687">ethical issues relating to the vaccination of children</a>, I believe it is important to answer this question, for two reasons. </p>
<p>First, whatever the decision, the principles on which it is based — and should be based — must be clear and transparent. </p>
<p>Second, surprisingly little attention has been paid to this issue in Canada, despite the decision to vaccinate children being a matter <a href="https://www.politico.eu/article/coronavirus-vaccine-children-ethics-science/">of science and ethics</a>. Science can clarify some of the costs and benefits of vaccination, but it cannot tell us which costs and benefits matter and when a cost-benefit ratio is favourable.</p>
<p>Fortunately, there is no need to generate a decision-making procedure from scratch. The procedure used by the <a href="https://www.gov.uk/government/groups/joint-committee-on-vaccination-and-immunisation">United Kingdom’s Joint Committee on Vaccination and Immunisation</a> (JCVI) in deciding whether to vaccinate healthy children aged 12-15 in the U.K. can provide important lessons about what not to do.</p>
<h2>Risks and benefits</h2>
<p>The most important factor is whether the benefits of vaccination outweigh its risks, and the degree to which the benefits outweigh the risks. In weighing these, the JCVI relied on what it called the “health perspective.” </p>
<p>Reasoning from this perspective, the JCVI held (in a <a href="https://www.gov.uk/government/publications/covid-19-vaccination-of-children-and-young-people-aged-12-to-17-years-jcvi-statement/jvci-statement-on-covid-19-vaccination-of-children-and-young-people-aged-12-to-17-years-15-july-2021">series</a> of <a href="https://www.gov.uk/government/publications/jcvi-statement-august-2021-covid-19-vaccination-of-children-and-young-people-aged-12-to-17-years/jcvi-statement-on-covid-19-vaccination-of-children-and-young-people-aged-12-to-17-years-4-august-2021">public</a> <a href="https://www.gov.uk/government/publications/jcvi-statement-september-2021-covid-19-vaccination-of-children-aged-12-to-15-years/jcvi-statement-on-covid-19-vaccination-of-children-aged-12-to-15-years-3-september-2021">statements</a>) that the chief benefits of vaccination against COVID-19 were the prevention of death, hospitalization, intensive care unit (ICU) admissions and pediatric inflammatory multisystem syndrome (PIMS) or multisystem inflammatory syndrome (MIS-C). </p>
<p>The chief harms of vaccination were myocarditis, or inflammation of the heart, and pericarditis, inflammation of the thin sack surrounding the heart, though it said these were rare and “typically self-limiting and resolved within a short time.”</p>
<p>The JCVI argued that the benefits of vaccination in this age group are only “marginally greater” than the harms and that therefore vaccination would not be offered to all members of this group.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/429412/original/file-20211029-25-1xe05b5.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A boy wearing a face mask getting an injection" src="https://images.theconversation.com/files/429412/original/file-20211029-25-1xe05b5.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/429412/original/file-20211029-25-1xe05b5.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/429412/original/file-20211029-25-1xe05b5.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/429412/original/file-20211029-25-1xe05b5.JPG?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/429412/original/file-20211029-25-1xe05b5.JPG?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/429412/original/file-20211029-25-1xe05b5.JPG?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/429412/original/file-20211029-25-1xe05b5.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">Twelve-year-old Sam Hallett got his shot at the Aboriginal Health and Wellness Centre in Winnipeg shortly after Health Canada approved COVID-19 vaccination in his age group in May.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Winnipeg Free Press-Mike Deal</span></span>
</figcaption>
</figure>
<p><a href="https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/recommendations-use-covid-19-vaccines/mrna-adolescents.html">NACI disagreed</a>, but did not outline the ethical principles it relied on in recommending vaccination for children ages 12-17.</p>
<p>JCVI’s decision not to offer all children vaccination against COVID-19 was flawed in numerous respects. (It was later <a href="https://www.gov.uk/government/publications/universal-vaccination-of-children-and-young-people-aged-12-to-15-years-against-covid-19/universal-vaccination-of-children-and-young-people-aged-12-to-15-years-against-covid-19">overruled by the chief medical officers of the U.K.’s four nations</a>.) NACI will do well to avoid these mistakes in making its decision about vaccinating children ages five to 11.</p>
<p>The Independent Scientific Advisory Group for Emergencies (Independent SAGE, a group of British scientists offering independent scientific advice on the prevention of COVID-19) <a href="https://www.independentsage.org/wp-content/uploads/2021/10/Independent-SAGE-JCVI-statement_transparency_final.pdf">has raised a number of concerns about the JCVI’s decision-making process</a>. </p>
<p>One concern is the way in which the JCVI calculated the benefits of vaccination, basing these calculations on risk to the population of all children of death, hospitalization, ICU admission and so on from COVID-19 infection, rather than the risks of these to children with a confirmed infection of COVID-19.</p>
<p>Another concern Independent SAGE raised was that the JCVI did not state which vaccine it considered when it examined the risks, a relevant concern <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/heart-inflammation-rates-higher-after-moderna-covid-19-shot-than-pfizer-vaccine-2021-10-01/">since heart inflammation rates appear to be higher after the Moderna vaccine than after the Pfizer</a> vaccine.</p>
<h2>Direct and indirect benefits</h2>
<p>Some of JVCI’s other mistakes related to value judgments, relying on the health perspective to make its decision. However, the JCVI was not consistent on what this included. </p>
<p>As noted, the JCVI mentioned the prevention of death, hospitalization, ICU admission and PIMS or MIS-C. These are not the only health benefits of vaccination against COVID-19. Some direct and indirect health benefits of vaccination were not clearly included.</p>
<p>The direct benefits include the prevention of <a href="https://www.who.int/publications/i/item/WHO-2019-nCoV-Post_COVID-19_condition-Clinical_case_definition-2021.1">long COVID</a> — a condition affecting anywhere <a href="https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(21)00198-X/fulltext">from two</a> <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/english-study-finds-long-covid-affects-up-1-7-children-months-after-infection-2021-09-01/">to 14</a> per cent of children infected with COVID-19 — and potential neurological and cognitive deficits caused by COVID-19 infection. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/429418/original/file-20211029-21-1rwklhi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A group of adolescents near a schoolyard play structure" src="https://images.theconversation.com/files/429418/original/file-20211029-21-1rwklhi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/429418/original/file-20211029-21-1rwklhi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=422&fit=crop&dpr=1 600w, https://images.theconversation.com/files/429418/original/file-20211029-21-1rwklhi.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=422&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/429418/original/file-20211029-21-1rwklhi.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=422&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/429418/original/file-20211029-21-1rwklhi.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=530&fit=crop&dpr=1 754w, https://images.theconversation.com/files/429418/original/file-20211029-21-1rwklhi.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=530&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/429418/original/file-20211029-21-1rwklhi.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=530&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Families and youth aged 12 and older line up for a COVID-19 vaccine at a Toronto school in May.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Nathan Denette</span></span>
</figcaption>
</figure>
<p>Preventing the <a href="https://doi.org/10.1136/bmj.n2052">negative mental and physical health effects</a> associated with school closures, limits on sporting and other such activities and physical distancing requirements are among the indirect benefits (though these were rightly noted by NACI in its recommendation to vaccinate adolescents). These health effects are important when deciding whether to vaccinate.</p>
<p>These are the known risks and benefits. However, the JCVI’s refusal to recommend vaccination to all children aged 12-15 was due to the uncertainties “regarding the magnitude of the potential harms” of vaccination, including myocarditis. </p>
<p>Although it gave considerable weight to unknown harms or uncertainties of vaccination, the JVCI did not consider potential unknown benefits of vaccination, or uncertainties about benefits. There was no reason to rule these out. Uncertainties about benefits seem to be of as much importance in thinking about the risk benefit profile of COVID-19 vaccination as uncertainties about risks. These, again, matter greatly to this decision.</p>
<p>The JCVI made another ethical error when it said the harms of vaccination should be given greater weight (relatively speaking) than the benefits. </p>
<p>There is no good reason to place a higher relative value on harms compared to benefits. Harms caused by vaccines are not worse than harms caused by COVID-19. It does not appear to be true that the rare and typically mild pericarditis or the myocarditis caused by vaccination is any worse than the pericarditis or the myocarditis caused (at <a href="https://www.newscientist.com/article/mg25133462-800-myocarditis-is-more-common-after-covid-19-infection-than-vaccination/">greater</a> <a href="https://www.nytimes.com/2021/10/06/health/covid-vaccine-children-dose.html?smid=tw-share">frequency</a>) by COVID-19 infection. This is not in line with other treatments considered for children, for which harms are not typically weighed more heavily than benefits.</p>
<h2>The well-being perspective</h2>
<p>It was a mistake for JCVI to make the decision about vaccination against COVID-19 in children purely on the basis of the health perspective. Health is important. But it is not the only value in the lives of children. Health is a priority because without it many other important benefits — enjoying friends, connecting with relatives, absorbing oneself in homework or music lessons — become much more difficult, if not impossible.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/429417/original/file-20211029-27-7g7pj5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A 12-year-old girl wearing a face mask with a sticker reading 'I got vaccinated'" src="https://images.theconversation.com/files/429417/original/file-20211029-27-7g7pj5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/429417/original/file-20211029-27-7g7pj5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/429417/original/file-20211029-27-7g7pj5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/429417/original/file-20211029-27-7g7pj5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/429417/original/file-20211029-27-7g7pj5.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=565&fit=crop&dpr=1 754w, https://images.theconversation.com/files/429417/original/file-20211029-27-7g7pj5.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=565&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/429417/original/file-20211029-27-7g7pj5.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=565&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Sound ethics and sound science show that vaccinating children is, all things considered, beneficial.</span>
<span class="attribution"><span class="source">(AP Photo/Angie Wang)</span></span>
</figcaption>
</figure>
<p>The JCVI mentioned the beneficial effects of vaccination on education. But it did not factor these benefits into the decision relating to vaccinating children against COVID-19. </p>
<p>Educational and other benefits afforded to children by vaccination matter greatly and must be factored into this decision. Moving beyond the health perspective into the well-being perspective encompasses a larger range of benefits and protections from vaccination, including safe and stable learning environments, time with extended family, sport, music performances and the many other things that make life happy and meaningful for children.</p>
<p>When making the decision whether to vaccinate children aged five to 11 against COVID-19, regulators in Canada must rely on both sound science and sound ethics. They must in particular consider all the health and well-being impacts of vaccination more generally; they must consider the uncertain harms and benefits of vaccination; and they must treat benefits and harms symmetrically.</p>
<p>Doing so will show that vaccinating children is, all things considered, beneficial.</p>
<p><em>Do you have a question about COVID-19 vaccines? Email us at <a href="mailto:ca-vaccination@theconversation.com">ca-vaccination@theconversation.com</a> and vaccine experts will answer questions in upcoming articles.</em></p><img src="https://counter.theconversation.com/content/169820/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Anthony Skelton 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>When making the decision whether to vaccinate children aged five to 11 against COVID-19, regulators in Canada must rely on sound ethics as well as sound science.Anthony Skelton, Associate Professor of Philosophy and Core Member of the Rotman Institute of Philosophy, Western UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1624972021-06-28T19:24:38Z2021-06-28T19:24:38ZDecriminalizing drug use is a necessary step, but it won’t end the opioid overdose crisis<figure><img src="https://images.theconversation.com/files/408451/original/file-20210625-26-1kcq5n5.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C4673%2C3113&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Advocating for decriminalization carries many benefits, including reducing the need for police involvement.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>Media, policy-makers, advocates and the public claim that decriminalization will make <a href="https://thetyee.ca/News/2021/05/12/Vancouver-Drug-Decriminalization-Plan-Disaster/">drug use safer</a> and <a href="https://vancouversun.com/opinion/donald-macpherson-federal-government-must-decriminalize-drugs-to-save-lives-and-protect-communities">save lives</a>. But can it?</p>
<p>Decriminalization has been somewhat of a policy buzzword in recent years, with <a href="https://www.theglobeandmail.com/topics/decriminalization/">ample media coverage</a>. It comes with both <a href="https://angusreid.org/opioid-crisis-covid/">public</a> and <a href="https://news.gov.bc.ca/releases/2021MMHA0017-000706">government</a> support.</p>
<p>A 2020 survey of more than 5,000 Canadians showed that <a href="https://angusreid.org/opioid-crisis-covid/">the majority (59 per cent) favour the decriminalization of drugs</a>. The <a href="https://www.cacp.ca/index.html?asst_id=2189">Canadian Association of Chiefs of Police</a> has also publicly supported decriminalization, along with British Columbia’s <a href="https://www2.gov.bc.ca/assets/gov/health/about-bc-s-health-care-system/office-of-the-provincial-health-officer/reports-publications/special-reports/stopping-the-harm-report.pdf">chief public health officer</a>. </p>
<p>Such support has also come with action. This year, the City of Vancouver submitted an application to Health Canada for an exemption from Canada’s Controlled Drugs and Substances Act — a policy reform referred to as <a href="https://vancouver.ca/people-programs/decriminalizing-simple-possession-of-illicit-drugs-in-vancouver.aspx">the Vancouver Model of decriminalization</a>.</p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/cKwh_Db8SQE?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">Vancouver activists work toward decriminalization.</span></figcaption>
</figure>
<h2>An alternative response</h2>
<p>In the simplest terms, decriminalization is an alternative response to criminal penalties for simple possession. The most recent data shows there were over <a href="https://www150.statcan.gc.ca/n1/pub/85-002-x/2020001/article/00010/tbl/tbl03-eng.htm">48,000 drug-related offences</a> in Canada in 2019, most of which were for possession for personal use. </p>
<p>The criminalization of drugs results in significant <a href="https://www.toronto.ca/wp-content/uploads/2018/05/9888-Harms-Associated-with-Drug-Laws.pdf">health, social and economic harms</a>, particularly to those who are homeless, experiencing mental health issues, racialized or Indigenous. By eliminating a criminalized response to drug possession, drug policy reform efforts can minimize the contact between people who use drugs and the criminal justice system, and may increase their <a href="https://doi.org/10.1177/1477370819887514">connection to health and social systems</a>.</p>
<p>However, alongside recognition of the ineffectiveness of criminalization and support for an alternative model, we need to be realistic with our expectations of what decriminalization can do. </p>
<h2>Decriminalization versus regulation</h2>
<p>Decriminalization does not mean that people can buy cocaine and heroin at the store as they would alcohol and tobacco. Only legal regulation can do that. Legal regulation, which <a href="https://gettingtotomorrow.ca/2020/03/10/considering-alternative-drug-policies-decriminalization-legal-regulation/">drug policy advocates endorse </a>, includes rules to control who can access what drug and when, as opposed to a free market or full legalization. </p>
<p>An example of legalization is Canada’s <em><a href="https://laws-lois.justice.gc.ca/eng/acts/C-24.5/">Cannabis Act</a></em>, which provides a legal framework to control the production, sale and possession of cannabis. </p>
<p>Unlike legal frameworks applied to the supply of drugs, decriminalization does not promote a “safer supply” of drugs. The overdose crisis is driven by an unpredictable, illegal drug supply that is <a href="https://ccsa.ca/sites/default/files/2020-05/CCSA-CCENDU-Adulterants-Contaminants-Co-occurring-Substances-in-Drugs-Canada-Bulletin-2020-en_0.pdf">marked with adulterants, contaminants and other substances</a>. Decriminalization won’t directly impact this supply of drugs, they will continue to be made in unregulated ways and places. </p>
<p>The illegal drug market will continue to be criminalized, unpredictable and precarious, and people will continue to be unsure of what’s in their drugs (in lieu of better <a href="https://doi.org/10.1016/j.drugpo.2018.10.001">drug checking services</a> or how potent they are. Under a decriminalized model, the overdose risk will inevitably remain high.</p>
<p>That said, decriminalization is still a necessary step in addressing the crisis.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/408429/original/file-20210625-23-1srr56v.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A woman holds a sign during a protest reading FOR DECRIM TO WORK WE NEED A SAFE SUPPLY" src="https://images.theconversation.com/files/408429/original/file-20210625-23-1srr56v.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/408429/original/file-20210625-23-1srr56v.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=405&fit=crop&dpr=1 600w, https://images.theconversation.com/files/408429/original/file-20210625-23-1srr56v.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=405&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/408429/original/file-20210625-23-1srr56v.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=405&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/408429/original/file-20210625-23-1srr56v.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=509&fit=crop&dpr=1 754w, https://images.theconversation.com/files/408429/original/file-20210625-23-1srr56v.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=509&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/408429/original/file-20210625-23-1srr56v.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=509&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Advocates are calling on the federal government and the City of Vancouver to halt the march toward possible drug decriminalization in the city, saying that addressing the drug supply is also crucial.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Darryl Dyck</span></span>
</figcaption>
</figure>
<h2>The benefits of decriminalization</h2>
<p><strong>Decriminalization changes the way we think about drugs.</strong>
Drug use will no longer be treated as a criminal issue, but instead a <a href="https://doi.org/10.1016/j.amepre.2019.08.012">health and social one</a>. This means that instead of addressing drugs through handcuffs, the focus will be on the root causes of drug use, including inequities rooted in housing and health care.</p>
<p><strong>Decriminalization saves governments money.</strong>
A large proportion of the justice system — police, courts, prisons — are occupied with <a href="https://www150.statcan.gc.ca/n1/pub/85-002-x/2020001/article/00010-eng.htm">drug-related crimes</a>. As seen in <a href="https://transformdrugs.org/blog/drug-decriminalisation-in-portugal-setting-the-record-straight">other decriminalized jurisdictions such as Portugal</a>, it can reduce the demands and costs to this system. </p>
<p>Considering the demonstrated need for addiction and mental health resources, the money saved could be well spent elsewhere, such as community-led responses, health care, housing and social programs.</p>
<p><strong>Decriminalization positively impacts people’s lives.</strong>
Especially for those targeted by drug law enforcement, namely poor, homeless and racialized people who use drugs, decriminalization can have a <a href="https://www.tni.org/files/publication-downloads/a_quiet_revolution_march_31_2016.pdf">positive impact</a>. </p>
<p>For example, eliminating <a href="https://scholar.harvard.edu/pager/publications/mark-criminal-record">criminal records</a> related to drug possession offences promotes opportunities for people to access employment and housing. Interactions between people who use drugs and police can also be reduced or, better yet, won’t happen at all.</p>
<p><strong>Decriminalization reduces stigma.</strong>
Negative views towards drugs and people who use them is a <a href="https://journalofethics.ama-assn.org/article/how-structural-violence-prohibition-and-stigma-have-paralyzed-north-american-responses-opioid/2020-08">major factor in the overdose crisis</a>. By reshaping the way our family, friends and the medical profession think about drugs, drug use can be talked about more openly and honestly. </p>
<p>Reducing stigma can also encourage people who use drugs to talk to their doctors about prescription-based therapies. At the very least, it will help bring drug use out from isolation, <a href="https://www2.gov.bc.ca/assets/gov/birth-adoption-death-marriage-and-divorce/deaths/coroners-service/statistical/illicitdrugoverdosedeathsinbc-findingsofcoronersinvestigations-final.pdf">where fatal overdoses tend to be the highest</a>.</p>
<p><strong>Decriminalization encourages people to call 911 at the scene of an overdose.</strong>
Fear of police is currently a barrier to this. Although people cannot be charged with simple possession at the scene of a drug overdose under <a href="https://www.canada.ca/en/health-canada/services/opioids/about-good-samaritan-drug-overdose-act.html">drug-related Good Samaritan laws</a>, fear of the police is still a <a href="https://doi.org/10.1016/j.drugpo.2020.103039">deterrent</a>. Legislation that decriminalizes drug possession can reassure people that they will not face criminal penalties. And police will no longer need to respond to calls about overdoses.</p>
<p><strong>Decriminalization is harm reduction.</strong>
Although some people fear that decriminalization may increase or encourage drug use, this concern is simply not supported by evidence. We know from dozens of countries, states and cities that have decriminalized drugs that <a href="https://doi.org/10.1093/bjc/azq038">use does not significantly increase</a>. In some places, <a href="https://www.tni.org/files/publication-downloads/a_quiet_revolution_march_31_2016.pdf">it has actually decreased</a>. </p>
<p>Decriminalization also lowers overdose and disease rates, while increasing people’s access to social services and health care. In this way, a decriminalization model is a basic <a href="https://journals.mcmaster.ca/ghar/article/view/2319">harm reduction</a> approach, mitigating the harms experienced by people who use drugs by eliminating or minimizing the source of those harms: criminalization. </p>
<h2>A critical step</h2>
<p>Overall, the notion of decriminalization is not a panacea or a standalone solution to the harms of drug prohibition — but it is a critical step in the right direction. It will have a positive impact on the lives of so many people who are harmed daily from criminalization.</p>
<p>However, in recognizing the <a href="https://doi.org/10.1177/07067437211019656">limitations of decriminalization models</a>, governments and other stakeholders can refocus efforts on what does directly impact the overdose crisis: a safer supply. Decriminalization must be paired with greater access to safer pharmaceutical alternatives to the toxic and illegal drug market. </p>
<p>That’s what will save lives.</p>
<p><em>Caitlin Shane, staff lawyer at Pivot Legal Society, co-authored this article.</em></p><img src="https://counter.theconversation.com/content/162497/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Alissa Greer receives funding from Simon Fraser University and the Social Sciences and Humanities Research Council. Dr. Greer is an assistant professor in the School of Criminology at Simon Fraser University, a research affiliate at the Canadian Institute for Substance Use Research, and a senior associate at Bunyaad Public Affairs.</span></em></p>Decriminalization is an important step in addressing the overdose crisis, but it is crucial that other approaches — like regulation — are also in place.Alissa Greer, Assistant Professor in the School of Criminology, Simon Fraser UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1464742020-09-22T19:58:52Z2020-09-22T19:58:52ZDrug Safety: Health Canada must act faster when approved medications show risks<figure><img src="https://images.theconversation.com/files/359404/original/file-20200922-20-lh0l7h.png?ixlib=rb-1.1.0&rect=0%2C1%2C1280%2C716&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Despite monitoring the same drugs, Australia, Canada, the United Kingdom and the United States issued the same drug warnings only seven per cent of the time over a 10-year period.</span> <span class="attribution"><span class="source">(Pixabay)</span></span></figcaption></figure><p>If a drug is available in multiple countries, it will have the same ingredients. Human bodies are the same regardless of what country that they’re in. Therefore, if a drug has a safety problem in Canada, it should cause the same problem in Australia, the United Kingdom or the United States. But not necessarily, according to government agencies such as Health Canada that regulate drugs.</p>
<p>I’m part of a multi-country group that is looking at the safety advisories put out in Australia, Canada, the United Kingdom and the United States between the start of 2007 to the end of 2016. </p>
<p>In total, there were 1,441 warnings that discussed 680 drug-risk issues (one drug could have more than a single risk). We found major differences among regulators in their decisions to warn the public. Over this 10-year period, all four countries issued the same warnings <a href="https://doi.org/10.1001/jamainternmed.2019.0294">only seven per cent of the time</a>.</p>
<h2>Warnings and withdrawals</h2>
<p>The timing of the decision to issue a warning also varied widely. For example, there is a group of blood thinners used by people at risk of a stroke or who have blood clots in their lungs. But if these drugs aren’t used properly, they can also cause serious and sometimes fatal bleeding, hence the need to put out a warning. </p>
<p>Health Canada and the U.S. Food and Drug Administration (FDA) approved one of these drugs, dabigatran, at approximately the same time in 2008. But the FDA issued its warning about bleeding in mid-2013, whereas <a href="https://doi.org/10.1002/pds.5072">Health Canada’s warning did not come until early 2015</a>, more than 18 months later.</p>
<figure class="align-right ">
<img alt="Cover of Terence H. Young's book Death by Prescription: title and author on orange and black bars agains a background photo of pills spilling out of several medication bottles." src="https://images.theconversation.com/files/358728/original/file-20200917-16-4x6nm9.png?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/358728/original/file-20200917-16-4x6nm9.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=900&fit=crop&dpr=1 600w, https://images.theconversation.com/files/358728/original/file-20200917-16-4x6nm9.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=900&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/358728/original/file-20200917-16-4x6nm9.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=900&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/358728/original/file-20200917-16-4x6nm9.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=1131&fit=crop&dpr=1 754w, https://images.theconversation.com/files/358728/original/file-20200917-16-4x6nm9.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=1131&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/358728/original/file-20200917-16-4x6nm9.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=1131&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Former MP Terence H. Young wrote Death By Prescription after his daughter died while she was taking cisapride.</span>
<span class="attribution"><a class="source" href="http://www.mosaic-press.com/product/death-by-prescription/">(Mosaic Press)</a></span>
</figcaption>
</figure>
<p>Perhaps even more troubling is that when drugs are removed from the market in one country, they can still be bought in another. One notable example is cisapride, also known by its brand name Prepulsid, a drug used to treat gastrointestinal disorders such as heartburn. </p>
<p>But the drug could also cause irregular heart beating, which could be fatal. In the U.S., 80 deaths led to the FDA’s decision to take it off the market on July 14, 2000. In Canada, the manufacturer <a href="https://www.cbc.ca/news/canada/medication-pulled-from-u-s-shelves-still-in-canada-1.219064">Janssen said cisapride “remains safe and effective”</a> when used appropriately. Health Canada agreed and the drug continued to be sold for another month. </p>
<p>Former MP Terence Young’s daughter was one of the victims of cisapride in Canada. Young tells the story of his subsequent battle to bring publicity to her death in his book <a href="http://www.mosaic-press.com/product/death-by-prescription/"><em>Death by Prescription</em></a>. When he was an MP he was responsible for the passage of <a href="https://doi.org/10.1503/cmaj.131850">Vanessa’s Law</a>, named after his daughter, that has the potential to significantly increase drug safety in Canada.</p>
<h2>‘Safety risks’ and ‘appropriate next steps’</h2>
<p>What happened in 2000 is still going on today in Canada. Ulipristal, also known as Fibristal, is used to treat uterine fibroids. In Europe, the five-milligram dose was suspended in March 2020 due to a case of serious hepatitis (liver damage) that ultimately led to the woman needing a liver transplant. The <a href="https://www.ema.europa.eu/en/news/suspension-ulipristal-acetate-uterine-fibroids-during-ongoing-ema-review-liver-injury-risk">European Medicines Agency</a> (EMA) recommended that the drug no longer be prescribed or dispensed, and that patients should stop taking it. </p>
<p>In early January 2019, Health Canada put out a safety alert warning about liver damage and placed restrictions on use of the drug with a promise to “<a href="https://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/68806a-eng.php">continue to monitor its use</a>” and to “take action if new safety risks are identified.” But despite the move by the EMA, Fibristal is still being sold in Canada and there have not been any new safety warnings.</p>
<p>In mid-January 2019, a trial of olaratumab (Lartruvo), a drug for the treatment of soft tissue sarcoma, <a href="https://www.biospace.com/article/eli-lilly-withdraws-lartruvo-off-the-market/">showed that the drug didn’t work</a> and Eli Lilly, the drug’s maker, announced that it was pulling it from the market. And it was — in the <a href="https://investor.lilly.com/news-releases/news-release-details/lilly-establish-access-program-patients-it-prepares-withdraw">U.S.</a> and <a href="https://www.ema.europa.eu/en/medicines/human/referrals/lartruvo">Europe</a>. </p>
<p>Here in Canada, there was <a href="https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/68974a-eng.php">an announcement by Lilly and Health Canada</a> at the end of January 2019 that the drug did not prolong the lives of patients. Health Canada said that it was “currently working with the manufacturer to determine the appropriate next steps.” This drug is also still being sold here.</p>
<h2>Approval vs. monitoring</h2>
<p>There are multiple factors that could be involved, but one stands out. Health Canada pays much less attention to the safety of drugs already on the market than it does to getting new drugs approved. Over the past 10 years, <a href="https://shpm.info.yorku.ca/files/2020/09/Health-Canada-funding-distribution-2004-2020.pdf">Health Canada has consistently devoted three times as much money and three times as many people</a> to getting new drugs onto the market compared to making sure that drugs already being sold are safe.</p>
<p>In the midst of the COVID-19 pandemic, with all of us hoping for new treatments and a vaccine, it’s crucial that we know that we can rely on Health Canada to make sure that new drugs and vaccines are safe. If we want that assurance, we need to insist that Health Canada takes drug safety seriously and spends what is necessary.</p><img src="https://counter.theconversation.com/content/146474/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>Health Canada devotes far more resources to getting new drugs onto the market compared to making sure that drugs already being sold are safe.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/1460612020-09-21T13:38:41Z2020-09-21T13:38:41ZExplainer: How clinical trials test COVID-19 vaccines<figure><img src="https://images.theconversation.com/files/358513/original/file-20200917-14-1p5cq9j.jpg?ixlib=rb-1.1.0&rect=299%2C0%2C4693%2C3502&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A lab technician holds a vial of a COVID-19 vaccine candidate during testing at the Chula Vaccine Research Center, run by Chulalongkorn University in Bangkok, Thailand on May 25, 2020. </span> <span class="attribution"><span class="source">(AP Photo/Sakchai Lalit)</span></span></figcaption></figure><p>On Sept. 4, 2020, <a href="https://www.politico.com/news/2020/09/04/trump-coronavirus-vaccine-october-409248">President Donald Trump announced</a> that we will have a vaccine for COVID-19 “before the end of the year and maybe even before Nov. 1.” As an election looms in the United States, the declaration fuelled worry that a COVID-19 vaccine may be approved before scientific vetting is complete.</p>
<p>In the United States, review and licensure of vaccines is the responsibility of the Food and Drug Administration (FDA). But the agency’s handling of emergency use authorizations for <a href="https://www.statnews.com/2020/06/16/hydroxychloroquine-emergency-use-patients-politicians/">two anti-malaria drugs</a> and <a href="https://www.sciencemag.org/news/2020/08/fda-s-green-light-treating-covid-19-plasma-critics-see-thin-evidence-and-politics">convalescent blood plasma</a> for the treatment of COVID-19 have led to claims it has become <a href="https://www.citizen.org/news/blatant-politicization-of-the-fda-hurts-its-credibility/">politicized</a>.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/358514/original/file-20200917-14-33bn21.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="A purple-gloved hand is selecting one of nine vials of blood in a green stand." src="https://images.theconversation.com/files/358514/original/file-20200917-14-33bn21.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/358514/original/file-20200917-14-33bn21.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=402&fit=crop&dpr=1 600w, https://images.theconversation.com/files/358514/original/file-20200917-14-33bn21.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=402&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/358514/original/file-20200917-14-33bn21.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=402&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/358514/original/file-20200917-14-33bn21.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=505&fit=crop&dpr=1 754w, https://images.theconversation.com/files/358514/original/file-20200917-14-33bn21.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=505&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/358514/original/file-20200917-14-33bn21.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=505&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Blood samples from volunteers are handled in the laboratory at Imperial College in London, on July 30, 2020. Imperial College is working on the development of a COVID-19 vaccine.</span>
<span class="attribution"><span class="source">(AP Photo/Kirsty Wigglesworth)</span></span>
</figcaption>
</figure>
<p>Such is the worry about the impartiality of the FDA that <a href="https://www.statnews.com/pharmalot/2020/09/07/pharma-covid-19-vaccine-drew-a-line/">pharmaceutical companies drew a line in the sand</a> and <a href="https://www.pfizer.com/news/press-release/press-release-detail/biopharma-leaders-unite-stand-science">pledged publicly</a> to “only submit [a vaccine] for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study.”</p>
<p>“Hell has frozen over,” <a href="https://www.statnews.com/2020/09/10/hell-has-frozen-over-pharmaceutical-industry-stands-in-for-politically-impaired-fda/">remarked commentators</a>.</p>
<p>But what is a Phase 3 clinical study? And how does scientific testing provide us with reliable evidence that vaccines not only work but are safe?</p>
<h2>Vaccine development</h2>
<p><a href="https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation">Vaccine development</a> can be thought of as the process of separating the parts of an infectious agent that make us sick, from those that induce an immune response and protect us from future infection. As this separation can be accomplished in myriad ways, vaccines are diverse. </p>
<p>Vaccine candidates for COVID-19 <a href="https://doi.org/10.1038/d41586-020-01221-y">illustrate these diverse approaches</a>. Some, such as <a href="https://blogs.sciencemag.org/pipeline/archives/2020/08/17/sinopharms-inactivated-coronavirus-vaccine">SinoPharm’s inactivated coronavirus vaccine</a>, use killed whole coronavirus. Others, such as the <a href="https://www.statnews.com/2020/07/20/study-provides-first-glimpse-of-efficacy-of-oxford-astrazeneca-covid-19-vaccine/">Oxford University-AstraZeneca vaccine</a>, modify a different virus (in this case, chimpanzee adenovirus) to express coronavirus proteins. Yet others, such as <a href="https://www.nationalgeographic.com/science/2020/05/moderna-coronavirus-vaccine-how-it-works-cvd/#:%7E:text=The%20surface%20of%20the%20SARS,it%20can%20establish%20an%20infection.">Moderna’s mRNA vaccine</a>, use only small bits of viral genetic material. </p>
<p>In Canada, the <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/activities/fact-sheets/regulation-vaccines-human-canada.html">oversight of vaccines</a> is shared by <a href="https://www.canada.ca/en/health-canada.html">Health Canada</a> and the <a href="https://www.canada.ca/en/public-health.html">Public Health Agency of Canada</a>. The <a href="https://www.cdc.gov/vaccines/basics/test-approve.html">scientific evaluation of vaccines</a> involves animal testing, human clinical trials and post-approval surveillance. In many regards, the evaluation of vaccines is the same as the process for drugs. Because vaccines are given to healthy people, however, there is an even greater emphasis in vaccine testing on safety. </p>
<h2>Animal testing</h2>
<p>The first step in evaluating a vaccine is animal testing. Animals are given differing doses of vaccine to check for adverse events and an immune response. </p>
<p>As the virus that causes COVID-19 is new, there was no animal model for the disease. <a href="https://doi.org/10.1126/science.abc6141">Recent work</a> has demonstrated that ferrets, cats and some non-human primates are prone to infection and can spread it to others. Animal testing provides information about safety (and perhaps efficacy) before a vaccine is tested on humans.</p>
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<iframe width="440" height="260" src="https://www.youtube.com/embed/74WQgNa3OsQ?wmode=transparent&start=0" frameborder="0" allowfullscreen=""></iframe>
<figcaption><span class="caption">What is vaccine development, and how can it be done faster during a pandemic?</span></figcaption>
</figure>
<h2>Human clinical trials</h2>
<p><a href="https://dx.doi.org/10.4103%2F0022-3859.173187">Human testing in clinical trials</a> is divided into three phases. Ensuring the safety of a vaccine is the prime concern through all phases of clinical trials. Vaccine efficacy is evaluated in different ways across the trial spectrum. Early-phase trials look for the production of antibodies against the virus, while late-phase trials evaluate whether the vaccine in fact prevents people from getting sick.</p>
<p>Phase 1 trials are the first evaluations of a vaccine in humans. These trials recruit 10 to 100 healthy volunteers who receive different doses of vaccine. Common adverse events to a vaccine include redness or soreness at the injection site, muscle pains, headache and fever. Blood is also drawn from the volunteers to assess the immune response to the vaccine, particularly the rise in antibodies and whether antibody levels are similar to those in people who have had the disease.</p>
<p>Phase 2 vaccine trials are similar to Phase 1 trials in terms of their focus on adverse events and immune response. Phase 2 trials, however, include hundreds of healthy volunteers who are more diverse to give a better indication of the safety and immune response in people likely to receive the vaccine in the future. </p>
<figure class="align-center ">
<img alt="A woman with her back to the camera sits on the examination table in an examination room as a man in a white coat and purple gloves gives her an injection in her upper left arm." src="https://images.theconversation.com/files/358515/original/file-20200917-18-1dkygf9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/358515/original/file-20200917-18-1dkygf9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/358515/original/file-20200917-18-1dkygf9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/358515/original/file-20200917-18-1dkygf9.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/358515/original/file-20200917-18-1dkygf9.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/358515/original/file-20200917-18-1dkygf9.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/358515/original/file-20200917-18-1dkygf9.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">Pharmacist Michael Witte, left, gives Rebecca Sirull, right, a shot in the first-stage safety study clinical trial of a potential vaccine for COVID-19 on March 16, 2020, at the Kaiser Permanente Washington Health Research Institute in Seattle. Sirull was the third patient to receive the shot in the study.</span>
<span class="attribution"><span class="source">(AP Photo/Ted S. Warren)</span></span>
</figcaption>
</figure>
<p>As Phase 1 and 2 trials involve relatively small numbers of people, they only give us information on vaccine side-effects that are very common (affecting more than 10 per cent of people) and common (affecting more than one per cent of people). Vaccine efficacy is only evaluated indirectly through measuring antibody levels.</p>
<p>It is only the Phase 3 trials that can provide a pivotal demonstration that a vaccine both works and is safe. Phase 3 vaccine trials are large randomized controlled trials conducted in the community. In these trials people either receive the vaccine or a placebo. If fewer people who received the vaccine become sick compared to those who received placebo, we have direct evidence that the vaccine prevents disease.</p>
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<em>
<strong>
Read more:
<a href="https://theconversation.com/ethics-must-not-be-ignored-when-testing-covid-19-vaccines-141736">Ethics must not be ignored when testing COVID-19 vaccines</a>
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</em>
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<p>A Phase 3 trial may involve tens of thousands of volunteers who receive the vaccine, further providing reliable information on adverse events, including those that are uncommon (affecting fewer than one per cent of people) or rare (affecting fewer than 0.1 per cent of people).</p>
<p>A vaccine may be licensed for use after a successful Phase 3 trial.</p>
<p>Of the 321 <a href="https://cepi.net/news_cepi/321-vaccine-candidates-against-covid-19-now-in-development/">vaccines for COVID-19 in development</a>, 27 are in Phase 1 or 2 trials and six are being evaluated in Phase 3 trials. In total, these trials seek to enrol 280,000 people from 34 countries. No COVID-19 vaccine has been licensed in Canada or the United States. </p>
<h2>Post-approval surveillance</h2>
<p>Once a vaccine is licensed, continued monitoring for safety is critical. Reliable detection of very rare (affecting fewer than 0.01 per cent of people) vaccine adverse events requires information on hundreds of thousands of people. The <a href="https://www.canada.ca/en/public-health/services/immunization/canadian-adverse-events-following-immunization-surveillance-system-caefiss.html">Canadian Adverse Events Following Immunization Surveillance System</a> monitors the safety of marketed vaccines, publishes reports regularly and identifies the need for further study should a safety issue be identified.</p>
<p>Provided that a COVID-19 vaccine successfully navigates human clinical trials and is subjected to continuing safety monitoring after it is licensed, we have good grounds to believe that the vaccine both works and is safe.</p><img src="https://counter.theconversation.com/content/146061/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Charles Weijer consults with Cardialen, Eli Lilly & Company, and Research Triangle Institute (RTI) International.</span></em></p>Will a vaccine for COVID-19 be safe? Animal testing, human clinical trials and post-approval surveillance give us good grounds to believe that a future approved vaccine will work and be safe.Charles Weijer, Professor of medicine, epidemiology & biostatistics, and philosophy, Western UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1381982020-05-11T17:34:41Z2020-05-11T17:34:41ZCoronavirus: Importing products without bilingual labels endangers francophones<figure><img src="https://images.theconversation.com/files/333845/original/file-20200510-49546-1mbmlcj.jpg?ixlib=rb-1.1.0&rect=0%2C0%2C2654%2C1792&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Flags fly outside of Montréal City Hall in June 2018. Health Canada has suspended official languages rules on bilingual labelling in an effort to speed up the importation of certain disinfectant and cleaning products during the coronavirus pandemic.</span> <span class="attribution"><span class="source">THE CANADIAN PRESS/Sidhartha Banerjee</span></span></figcaption></figure><p>As the COVID-19 pandemic continues to wreak havoc, Canada has responded with an array of emergency measures to combat the spread of the virus. </p>
<p>In a <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/covid19-interim-order-drugs-medical-devices-special-foods.html">controversial order</a>, Health Canada has suspended official languages rules on bilingual labelling in an effort to speed up the importation of certain disinfectant and cleaning products and mitigate the impacts of shortages.</p>
<p>It is worth recalling that French and English are Canada’s official languages, which means, in principle, that they have equal rights and status under our Constitution. </p>
<p>Bilingual labelling requirements are governed by the <a href="https://www.canlii.org/en/ca/laws/stat/rsc-1985-c-c-38/146027/rsc-1985-c-c-38.html">Consumer Packaging and Labelling Act</a> and its regulations, the <a href="https://www.canlii.org/en/ca/laws/regu/sor-2015-17/167079/sor-2015-17.html">Hazardous Products Regulations</a> and, more relevant to the current crisis, by the <a href="https://www.canlii.org/en/ca/laws/regu/crc-c-870/162331/crc-c-870.html">Food and Drug Regulations</a>. The bilingual labelling rules promote official bilingualism by normalizing the equal status of French and English and by ensuring the visibility of both official languages on everyday consumer products.</p>
<p>As researchers and professors who specialize in language rights and policies, we are concerned by Canada’s willingness to suspend the legal framework that applies to official languages during times of national emergency. The situation is highly problematic and raises concerns about the rule of law, public safety and fairness.</p>
<h2>Timeline</h2>
<p>On March 18, 2020, Health Canada <a href="https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/72623a-eng.php">issued an alert</a> to notify the public that it sought to import certain products deemed useful in the fight against COVID-19, despite their non-compliance with the regulatory requirements on bilingual labelling. </p>
<p>Health Canada said that “in light of the unprecedented demand and urgent need for products that can help limit the spread of COVID-19 — including hand sanitizers, disinfectants and personal protective equipment … Health Canada is facilitating access to products that may not fully meet current regulatory requirements, as an interim measure.”</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/333849/original/file-20200510-49546-76pyze.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/333849/original/file-20200510-49546-76pyze.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=237&fit=clip" srcset="https://images.theconversation.com/files/333849/original/file-20200510-49546-76pyze.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=410&fit=crop&dpr=1 600w, https://images.theconversation.com/files/333849/original/file-20200510-49546-76pyze.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=410&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/333849/original/file-20200510-49546-76pyze.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=410&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/333849/original/file-20200510-49546-76pyze.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=515&fit=crop&dpr=1 754w, https://images.theconversation.com/files/333849/original/file-20200510-49546-76pyze.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=515&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/333849/original/file-20200510-49546-76pyze.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=515&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">Minister of Health Patty Hajdu rises during Question Period in the House of Commons on Parliament Hill in Ottawa in January 2020.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Justin Tang</span></span>
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<p>On March 25, Parliament passed the <a href="https://www.canlii.org/en/ca/laws/astat/sc-2020-c-5/166800/sc-2020-c-5.html">COVID-19 Emergency Response Act</a>, which amended, among other things, the <a href="https://www.canlii.org/en/ca/laws/stat/rsc-1985-c-f-27/latest/rsc-1985-c-f-27.html">Food and Drugs Act</a> to give the Minister of Health the authority to make regulations to avoid shortages of designated therapeutic products. On March 30, Health Minister Patty Hajdu exercised her new powers and passed an <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/covid19-interim-order-drugs-medical-devices-special-foods.html">interim order</a> suspending the rules on bilingual labelling.</p>
<p>As of today, <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/disinfectants/covid-19/products-accepted-under-interim-measure.html">Health Canada has exempted more than 330 products</a> from the rules on bilingual labelling, including a range of Clorox household cleaning products as well as Purell hand sanitizers. Pursuant to the minister’s order, these products can now be found on Canadian store shelves with English-only printed labels.</p>
<h2>Safety concerns</h2>
<p>The <a href="https://fcfa.ca/sante-canada-elimine-lobligation-detiquetage-bilingue-des-produits-nettoyants-un-manque-de-respect-couper-le-souffle/">Fédération des communautés francophones et acadiennes/Federation of Francophone and Acadian Communities</a> criticized Health Canada’s “intolerable” order on the grounds that it “tramples on the principle of equality of our two official languages and constitutes a blatant lack of respect for the more than seven million Canadians whose first language is French.”</p>
<p>The Québec Federation of Labour (QFL) <a href="https://ftq.qc.ca/communiques/ftq-outree-de-decision-dottawa-de-suspendre-letiquetage-bilingue-canada/">also condemned the move, saying it was “outraged”</a>. According to Denis Bolduc, the organization’s secretary-general: </p>
<blockquote>
<p>“Francophones have the right to know what they can expect to find in essential items, including cleaning products, whether they come from the United States or not. It is dangerous to put aside the bilingual labelling rules in Canada. This is a public safety issue for both unilingual workers as well as their children and families.”</p>
</blockquote>
<p>The <a href="https://mailchi.mp/1ba4a8ba235c/les-mmes-normes-de-scurit-pour-tous-les-canadiens-en-temps-de-pandmie?e=39f6be30bb">Société santé en français</a>, the national association of Francophone health networks, also has strong public safety issues. It said in a statement:</p>
<blockquote>
<p>“This decision … calls into question the safety of the Canadian public, including Francophone and Acadian minority communities. Despite the exceptional circumstances that explain this decision, it is difficult to ignore that unilingual labelling compromises safety standards for individuals living in these communities across Canada.”</p>
</blockquote>
<p>Health Canada, on the other hand, does not believe its decision to suspend bilingual labelling rules endangers Canadian Francophones.</p>
<p>On the <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/disinfectants/covid-19/products-accepted-under-interim-measure.html">web page that lists the authorized products</a>, the ministry claims that “these products may not fully meet regulatory requirements, but do not compromise the safety of Canadians.” </p>
<h2>‘Read the label’</h2>
<p>That claim is difficult to reconcile with Health Canada’s ongoing campaign on <a href="https://www.canada.ca/en/health-canada/services/home-safety/household-chemical-safety.html">its website</a> urging all Canadians who purchase household disinfectants to “read the label to determine its ingredients and any special handling instructions” and “to follow the instructions” in order to “prevent and injury” or “save a life.”</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/333850/original/file-20200510-49538-173t092.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/333850/original/file-20200510-49538-173t092.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=399&fit=crop&dpr=1 600w, https://images.theconversation.com/files/333850/original/file-20200510-49538-173t092.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=399&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/333850/original/file-20200510-49538-173t092.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=399&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/333850/original/file-20200510-49538-173t092.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=502&fit=crop&dpr=1 754w, https://images.theconversation.com/files/333850/original/file-20200510-49538-173t092.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=502&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/333850/original/file-20200510-49538-173t092.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">
<figcaption>
<span class="caption">Customers line up at the Costco store Terrebonne, Que., in April 2020.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Ryan Remiorz</span></span>
</figcaption>
</figure>
<p>Clearly, unilingual French speakers cannot heed Health Canada’s advice while the rules on bilingual labelling are suspended as a result of the <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/covid19-interim-order-drugs-medical-devices-special-foods.html">interim order</a>.</p>
<p>In the <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/covid19-interim-order-drugs-medical-devices-special-foods/note.html">explanatory note accompanying the interim order</a>, Hajdu says that due to the urgent nature of the health crisis, “broad stakeholder consultation is not possible.”</p>
<p>Unlike the federal health minister, we believe that appropriate steps should have been taken so that seven million French-speaking Canadians are not left struggling to decipher English-only labels. Canada’s national emergency plans must take into account the fundamental rights and safety of all Canadians, including the country’s francophone populations.</p><img src="https://counter.theconversation.com/content/138198/count.gif" alt="La Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Les auteurs ne travaillent pas, ne conseillent pas, ne possèdent pas de parts, ne reçoivent pas de fonds d'une organisation qui pourrait tirer profit de cet article, et n'ont déclaré aucune autre affiliation que leur organisme de recherche.</span></em></p>Seven million French-speaking Canadians shouldn’t have to decipher English-only labels during the pandemic. Ottawa must take into account the fundamental rights and safety of all Canadians.François Larocque, Professor, Research Chair in Language Rights, Faculty of Law, Common Law Section | Professeur, Chaire de recherche Droits et enjeux linguistiques, Faculté de droit, Section de common law, L’Université d’Ottawa/University of OttawaLinda Cardinal, Professeure titulaire, École d'études politiques, Université d'Ottawa et Université de l'Ontario français, L’Université d’Ottawa/University of OttawaLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1300212020-01-19T13:25:14Z2020-01-19T13:25:14ZCannabis edibles pose serious risks to our kids<figure><img src="https://images.theconversation.com/files/310571/original/file-20200116-181593-1hby97x.jpg?ixlib=rb-1.1.0&rect=53%2C0%2C6000%2C3997&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Cannabis edibles like sour candy straws are now available for purchase and consumption, but the risks from overdosing are quite high.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>In October 2019, Health Canada approved the <a href="https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/resources/regulations-edible-cannabis-extracts-topicals.html">sale of cannabis edibles, topicals and extracts for early 2020</a>. Let us hope that one of Health Canada’s New Year’s resolutions is to do a better job of regulating cannabis and protecting the public, and in particular youth, from harm.</p>
<p>Cannabis edibles offer a lucrative opportunity for licensed cannabis producers and retailers in both the medical and recreational market. However, while governments and businesses move to meet public demand and their bottom lines, there is a need to acknowledge the inherent risks cannabis, and in particular edibles, can pose.</p>
<p>While edibles may provide a delivery system that provides the intoxicating effects of cannabis while avoiding the risks of smoking, the delayed and variable absorption of cannabis edibles can <a href="http://dx.doi.org/10.5811/westjem.2015.3.25284">result in over-consumption and unpredictable results</a>. </p>
<p>As both an addiction medicine and family physician, I have seen many adolescents whose cannabis use has negatively affected their mood, motivation, sleep and ability to simply function.</p>
<h2>Substantial harm to youth</h2>
<p>The intoxicating effects of cannabis when taken orally can be delayed up to 90 minutes, peaking a few hours later, and may <a href="https://doi.org/10.2165/00003088-200342040-00003">last for several hours</a>. Aside from the expected diminished concentration, decreased executive functioning and impaired memory, acute cannabis toxicity can present as severe anxiety, panic attacks, nausea, delirium or psychosis. </p>
<p>In Colorado, where cannabis sales were legalized for people 21 and older in 2012, <a href="https://dx.doi.org/10.1001%2Fjama.2014.17057">edible products are the major cause of cannabis intoxication</a>. Emergency room visits and hospitalizations due to <a href="https://dx.doi.org/10.5811%2Fwestjem.2019.4.39935">adverse reactions from cannabis edibles have increased in Colorado since legalization</a>, and adolescent visits rose to <a href="https://doi.org/10.1016/j.jadohealth.2017.12.010">4.9 per 1,000 visits in 2015</a> from 1.8 per 1,000 visits in 2009.</p>
<p>It’s true that often these symptoms are temporary and that a cannabis overdose likely <a href="https://doi.org/10.1002/cbdv.200790151">won’t kill someone</a>, but it can cause significant mental and physical disability. </p>
<p>During the early phase of cannabis legalization in Oregon and Alaska, 253 overdoses — some requiring stays in the intensive-care unit and including one death — were reported to poison centres over a 16-month period: 71 individuals were under the age of 12, and 42 <a href="https://www.ncbi.nlm.nih.gov/pubmed/30676820">were between the ages of 12 and 17</a>. The median age was only 20 years old.</p>
<p>Beyond the risks of acute toxicity, cannabis use that starts in adolescence has been linked to a variety of harms including <a href="http://doi.org/10.1001/jamapsychiatry.2018.4500">depression, suicidality</a>, <a href="https://dx.doi.org/10.1056%2FNEJMra1402309">psychosis</a> and <a href="https://dx.doi.org/10.5811%2Fwestjem.2019.4.39935">schizophrenia</a>. Considering that Canadian youth are <a href="https://www.theglobeandmail.com/news/national/canadian-teens-lead-developed-world-in-cannabis-use-unicef-report/article11221668/">the highest adolescent users in the world</a> and that they believe, <a href="https://doi.org/10.1503/cmaj.191217">despite strong scientific evidence to the contrary</a>, that cannabis will improve their mood, anxiety and sleep, there are significant challenges in protecting them from potential cannabis-related harms.</p>
<h2>Intoxicants aren’t candy</h2>
<p>Unfortunately, Health Canada has allowed troublingly high THC concentrations (<a href="https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/laws-regulations/regulations-support-cannabis-act.html">up to 30 per cent in some cases</a>) in dried cannabis products. While many edibles will be purchased directly from retailers, edibles made at home may have higher THC concentrations.</p>
<p>Health Canada has also done little to rein in misleading advertising by the cannabis industry: it has allowed licensed producers to <a href="https://www.cfp.ca/content/cfp/65/12/864.full.pdf">make unsubstantiated claims about the medicinal value of cannabis</a>, which only further contributes to positive adolescent social attitudes towards cannabis. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/310572/original/file-20200116-181598-1gzdhxs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=1000&fit=clip"><img alt="" src="https://images.theconversation.com/files/310572/original/file-20200116-181598-1gzdhxs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/310572/original/file-20200116-181598-1gzdhxs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=399&fit=crop&dpr=1 600w, https://images.theconversation.com/files/310572/original/file-20200116-181598-1gzdhxs.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=399&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/310572/original/file-20200116-181598-1gzdhxs.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=399&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/310572/original/file-20200116-181598-1gzdhxs.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=501&fit=crop&dpr=1 754w, https://images.theconversation.com/files/310572/original/file-20200116-181598-1gzdhxs.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=501&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/310572/original/file-20200116-181598-1gzdhxs.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"></a>
<figcaption>
<span class="caption">Chocolates with marijuana will be widely available as edible products are introduced to the market.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>While Health Canada <a href="https://www.canada.ca/en/health-canada/services/cannabis-regulations-licensed-producers/packaging-labelling-guide-cannabis-products/guide.html#a51">does not permit direct advertising of cannabis</a> and requires plain packaging and warnings on all cannabis products, the cannabis industry is able to market through media stories and their websites. </p>
<p>The Ontario Cannabis Store, a Crown corporation, <a href="https://ocs.ca/blogs/facts-about-cannabis-consumption/what-are-edibles">has a picture of chocolate squares to advertise edibles on their website</a> and is set to roll out more than 50 new edible and vape products this week. Canopy Growth is reportedly rolling out cannabis-infused flavoured sparkling waters and gourmet chocolate bars in <a href="https://ottawa.ctvnews.ca/not-your-mom-s-ginger-ale-cannabis-infused-drinks-to-hit-shelves-in-december-1.4660889">three different flavours</a>.</p>
<h2>Health Canada needs to do better</h2>
<p>Public consumption of edibles is likely to increase. In Colorado, <a href="http://www.cannabisconsumer.org/uploads/9/7/9/6/97962014/2014_med_annual_report_1.pdf">edibles accounted for 45 per cent of all sales by 2014</a>. Health Canada’s packaging guidelines and dose limits for edibles (<a href="https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/resources/regulations-edible-cannabis-extracts-topicals.html">10 milligrams per item</a>) will only go so far in mitigating potential harms. </p>
<p>Health Canada has vaguely stated that the products should not be appealing to youth but it is hard to imagine that chocolates and flavoured drinks with names like “<a href="https://ocs.ca/search?product=4350458627916&q=gummies">Pineapple Orange Gummies</a>” would not be enticing to that population.</p>
<p>A more concerted public health campaign and detailed warnings on products are needed. Targeting successful cannabis education to youth is a challenging task but an imperative one.</p>
<p>While the Supreme Court of Canada ruled to give Canadians legal access to cannabis, Health Canada now bears the regulatory and educational responsibility. In 2018, <a href="https://nationalpost.com/news/health-canadas-marijuana-education-campaign-nuanced-expert-says">Health Canada committed a little over $100 million over six years for public cannabis education and surveillance</a>. But $186 million tax dollars <a href="https://business.financialpost.com/cannabis/cannabis-business/governments-raked-in-186-million-in-taxes-on-cannabis-trade-in-first-five-months-of-legalization">were collected in the first five months</a> of legalization. Health Canada could and should invest so much more into oversight and education. The collective health of our youth depends upon it. </p>
<p>[ <em>Deep knowledge, daily.</em> <a href="https://theconversation.com/ca/newsletters?utm_source=TCCA&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=deepknowledge">Sign up for The Conversation’s newsletter</a>. ]</p><img src="https://counter.theconversation.com/content/130021/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Anita Srivastava received a grant from the Canadian College of Family Physicians for 5000K to develop an educational program for family physicians on medical cannabis and youth. </span></em></p>As cannabis candies and chocolates become widely available, sweeter edibles may be more appealing to youth. We need to work to minimize the potential health impacts.Anita Srivastava, Associate Professor, Department of Family and Community Medicine, University of TorontoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1209652019-08-12T22:24:26Z2019-08-12T22:24:26ZHealth Canada and Big Pharma: Too close for comfort<figure><img src="https://images.theconversation.com/files/287170/original/file-20190807-144838-bg0a6t.jpg?ixlib=rb-1.1.0&rect=139%2C253%2C5062%2C3243&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">When drug companies and drug regulators, such as Health Canada, sit down together at "pre-submission meetings" this may have a negative impact on public health. </span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>Over the past few decades it’s become common practice for drug companies and drug regulators, such as Health Canada, to sit down together at what are called pre-submission meetings. </p>
<p>These are get-togethers where both parties talk about an upcoming application from the company. Health Canada’s <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions/industry.html">Guidance for Industry</a> on the management of drug submissions lays out some of the goals: familiarizing Health Canada’s review staff with a submission prior to its arrival, uncovering any major unresolved problems, identifying whether submitted studies are adequate, allowing Health Canada to redistribute funding if necessary.</p>
<p>These types of meetings sound benign or maybe actually positive. Health Canada gets to use its limited resources in the most productive way, the drug company doesn’t have to do extra unnecessary testing and, most importantly, new drugs may reach patients faster. </p>
<p>Moreover, if clinical trials of a new drug in humans are optimized, fewer people will be exposed to unknown risks. If trials are smaller and faster, they will be less expensive and that may mean lower drug prices.</p>
<p>But there are also potential downsides. </p>
<h2>More drug safety problems</h2>
<p>First, it’s Health Canada’s job to protect public health, not to make it less costly for companies to run trials. And the two are not necessarily synonymous. Less expensive trials are typically smaller trials, but fewer patients also means it’s harder to spot rarer side effects before drugs hit the market. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/287171/original/file-20190807-144868-1f38a2h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/287171/original/file-20190807-144868-1f38a2h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=414&fit=crop&dpr=1 600w, https://images.theconversation.com/files/287171/original/file-20190807-144868-1f38a2h.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=414&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/287171/original/file-20190807-144868-1f38a2h.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=414&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/287171/original/file-20190807-144868-1f38a2h.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=520&fit=crop&dpr=1 754w, https://images.theconversation.com/files/287171/original/file-20190807-144868-1f38a2h.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=520&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/287171/original/file-20190807-144868-1f38a2h.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=520&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Clinical trials are essential to the development of new and effective medications.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Getting through the regulatory system faster is also cheaper for drug companies, but speedier reviews equate to <a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1377415">more safety problems</a> once drugs are being sold. We also need to remember that in most cases Health Canada doesn’t need to rush new drugs to the market. <a href="http://dx.doi.org/10.1136/bmjopen-2018-023605">Only about one in 10</a> offer a significant improvement over what’s already available.</p>
<p>The idea that the price of drugs is a reflection of how much companies spend on research and development has been <a href="https://www.theatlantic.com/health/archive/2019/03/drug-prices-high-cost-research-and-development/585253/">debunked by the likes of Hank McKinnell, the former CEO of Pfizer</a>.</p>
<p>Finally, if Health Canada is giving drug companies advice about how to run their trials, then will the agency feel obliged to approve those trials once they are submitted, even if they don’t convincingly show a drug to be safe and effective? </p>
<p>As an analogy, suppose a judge meets with the prosecutor before a trial starts, to discuss with the prosecutor how best to present her case. As the defendant, how confident would you be that the judge will be objective in coming to a decision? </p>
<p>In the case of Health Canada and the pharmaceutical industry, the defendant is the Canadian public.</p>
<h2>A revolving door</h2>
<p>These pre-submission meetings occur alongside other ongoing relationships between drug companies and drug regulators. Health Canada already gets 50 per cent of the cost of operating its prescription drug program from money that companies are obliged to pay and it wants that to <a href="https://www.canada.ca/en/health-canada/programs/consultations-revised-fee-proposal-drugs-medical-device/document.html">go up to 75 per cent</a>. </p>
<p>Regulators in other countries recover upwards of 90 per cent of their costs from companies. Although not that visible a problem here in Canada, in the United States there is a revolving door between the Food and Drug Administration and the drug industry. After <a href="https://www.statnews.com/pharmalot/2019/06/27/scott-gottlieb-pfizer-board-fda/">Dr. Scott Gottlieb</a> resigned as FDA commissioner his next move was to the board of Pfizer.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/287169/original/file-20190807-144878-5h6v58.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/287169/original/file-20190807-144878-5h6v58.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=430&fit=crop&dpr=1 600w, https://images.theconversation.com/files/287169/original/file-20190807-144878-5h6v58.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=430&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/287169/original/file-20190807-144878-5h6v58.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=430&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/287169/original/file-20190807-144878-5h6v58.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=540&fit=crop&dpr=1 754w, https://images.theconversation.com/files/287169/original/file-20190807-144878-5h6v58.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=540&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/287169/original/file-20190807-144878-5h6v58.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=540&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Dr. Scott Gottlieb, former U.S. Food and Drug Administration Commissioner.</span>
<span class="attribution"><span class="source">AP Photo/J. Scott Applewhite</span></span>
</figcaption>
</figure>
<p>This type of relationship has garnered criticism in multiple different countries. When a British House of Commons Committee looked into the influence of the pharmaceutical industry on that country’s drug regulator, <a href="https://publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf">it concluded that the Medicines and Healthcare products Regulatory Agency (MHRA)</a>:</p>
<blockquote>
<p>“… like many regulatory organisations, is entirely funded by fees from those it regulates….This situation has led to concerns that it may lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies.” </p>
</blockquote>
<p>The European Medicines Agency recently organized a consultation on pre-submission meetings. In reply the <a href="https://english.prescrire.org/Docu/DOCSEUROPE/20190130_JointResponseEUOmbudsmanScientificAdvice.pdf">International Society of Drug Bulletins and the French drug bulletin, <em>Prescrire</em> wrote</a> that, “EMA’s confidential pre-submission ‘scientific advice’ to companies jeopardises its ability to make independent decisions.” These bodies advised that:</p>
<blockquote>
<p>“… experts involved in providing national pre-submission scientific advice must not be involved in any subsequent evaluation of European marketing authorisation applications for the same medicine.”</p>
</blockquote>
<h2>Weaker standards for approving drugs</h2>
<p>Critics of the intertwined nature of the regulation-industry relationship claim that one of the results is that <a href="https://doi.org/10.1136/bmj.i4437">weaker standards for approving new drugs</a> have become acceptable. </p>
<p>Many drugs are approved on the basis of surrogate endpoints — such as changes in the level of blood sugar or how much cancer tumours shrink — rather than outcomes that really matter to patients, such as whether they’ll have a better quality of life or whether they’ll live longer. </p>
<p>Half the new drugs approved come on the market <a href="https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2011.539">without any comparison to standard therapy,</a> leaving doctors and patients wondering whether the new drug is any better than the old one.</p>
<p>Is Health Canada’s relationship with drug companies the reason why one spokesperson told a reporter for the <em>Toronto Star</em> that the <a href="https://www.thestar.com/news/canada/2014/06/26/dangers_of_offlabel_drug_use_kept_secret.html">reason that it had never prosecuted a drug company</a> for illegally marketing unapproved uses was that it “has not been made aware of any specific similar issue in Canada and has not received complaints concerning these companies promoting off-label uses of their products in Canada?”</p>
<p>Drug companies have a job to do and so does Health Canada. Health Canada should not confuse what those two jobs are.</p>
<p>[ <em>Like what you’ve read? Want more?</em> <a href="https://theconversation.com/ca/newsletters?utm_source=TCCA&utm_medium=inline-link&utm_campaign=newsletter-text&utm_content=likethis">Sign up for The Conversation’s daily newsletter</a>. ]</p><img src="https://counter.theconversation.com/content/120965/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2016-2019, Joel Lexchin was a paid consultant on two projects: one looking at developing principles for conservative diagnosis (Gordon and Betty Moore Foundation) and a second deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient Oriented Research Support Unit and the St Michael’s Hospital Foundation). He also received payment for being on a panel at the American Diabetes Association, for a talk at the Toronto Reference Library, for writing a brief in an action for side effects of a drug for Michael F. Smith, Lawyer and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p>Drug companies have a job to do and so does Health Canada. When the relationship becomes murky, the public are at risk.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University, Emergency Physician at University Health Network, Associate Professor of Family and Community Medicine, University of TorontoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1164902019-05-20T14:26:55Z2019-05-20T14:26:55ZHealth Canada committees swimming in financial conflicts of interest<figure><img src="https://images.theconversation.com/files/274450/original/file-20190514-60532-mqczkw.jpg?ixlib=rb-1.1.0&rect=0%2C52%2C4970%2C2709&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Research shows that six of 11 Health Canada scientific advisory committees had a majority of members with a direct or indirect financial interest.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>Health Canada supplements its in-house expertise on prescription drug therapy and policy through the use of <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/scientific-expert-advisory-committees.html">scientific advisory committees</a> and <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/scientific-expert-advisory-panels.html.">panels</a>. </p>
<p>These committees and panels provide Health Canada with recommendations — such as adding a statement about disabling and potentially irreversible adverse reactions to information about fluoroquinolones (a widely used class of antibiotics). Another example would be putting a warning sticker on prescriptions for opioids — to highlight the risk of physical dependence, addiction and overdose.</p>
<p>Typically, people who sit on these committees and panels are experts in their field, although there are also representatives from drug companies and consumers. Those who are interested fill out an <a href="https://erci-iace.hc-sc.gc.ca/erci-iace/index-eng.jsp">online application form</a> listing their qualifications and expertise, and Health Canada chooses members from this list. Potential members then need to <a href="https://www.canada.ca/content/dam/hc-sc/documents/services/chemical-substances/chemicals-management-plan/form-affil-form-eng.pdf">complete a second form</a> disclosing any direct and indirect financial interests. </p>
<p>A direct financial interest includes current employment, investments in companies, partnerships, equity, royalties and a variety of other monetary relationships with a drug company. Indirect interests are things like consulting for a company, receiving personal educational grants, gifts or research funding.</p>
<p>I have just <a href="http://www.cmajopen.ca/lookup/doi/10.9778/cmajo.20190010">published a study in <em>CMAJ Open</em></a> in which I look at the extent of these financial interests in the 81 different individuals who sit on the 11 active committees and panels. Only a small minority have a direct financial interest, but 56 have an indirect interest and those with indirect interests were present on all 11 committees and panels. </p>
<p>In fact, six of the 11 committees had a majority of members with a direct or indirect financial interest. One chair had a direct financial interest and eight others had an indirect financial interest.</p>
<h2>Troubling lack of information</h2>
<p>The key question is whether those financial interests bias the advice that the committees and panels offer to Health Canada. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/274451/original/file-20190514-60541-trcbyn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/274451/original/file-20190514-60541-trcbyn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/274451/original/file-20190514-60541-trcbyn.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/274451/original/file-20190514-60541-trcbyn.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/274451/original/file-20190514-60541-trcbyn.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/274451/original/file-20190514-60541-trcbyn.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/274451/original/file-20190514-60541-trcbyn.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">Even the receipt of a small amount of money, or a meal, can affect an individual’s behaviour, according to research.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Unfortunately, my research cannot answer that question because Health Canada doesn’t release enough information. We don’t know the names of the companies that committee and panel members have a relationship with, how much money they receive from the companies or when they received it. Crucially, we don’t know how individuals voted on matters they were asked to consider.</p>
<p>This lack of information is troubling. Even the receipt of small amounts of money or the equivalent can affect behaviour. Meals valued at less than US$20 are associated with <a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/10.1001/jamainternmed.2016.2765">higher prescribing rates for drugs</a> made by the companies providing the meals. </p>
<p><a href="https://onlinelibrary.wiley.com/doi/abs/10.1111/1468-0009.12073">Research on voting patterns</a> of people serving on U.S. Food and Drug Administration advisory committees shows that members who have financial ties solely to the firm sponsoring a drug are more likely to vote in ways favourable to the sponsor. Similarly, the research shows that those who serve on advisory boards for sponsoring firms show “particularly strong pro‐sponsor bias.”</p>
<p>Importantly, conflict of interest declarations and waivers are publicly available on the FDA website. Financial conflict of interest is reported in dollar ranges (for example, $0-5,000, $5001-$10,000) and the way that individuals vote is recorded and made public.</p>
<h2>Canadians need unbiased advice</h2>
<p>Conflicts of interest among people who produce guidelines for doctors are considered such a serious problem that the <a href="https://www.ncbi.nlm.nih.gov/books/NBK209539/">U.S. Institute of Medicine</a> recommends that the chair of any panel should be free of all conflicts, as should the majority of members on the panel. </p>
<p>Neither of these conditions are met by Health Canada’s current policies.</p>
<p>Health Canada should follow the Institute of Medicine recommendations when constituting its committees and panels. It should also publicly release all of the information about direct and indirect financial interests that it collects. </p>
<p>Finally, Health Canada should record the votes of individual committee and panel members and provide a transcript of meetings — so that everyone can see whether voting patterns are linked to different types of financial interests with particular companies. </p>
<p>The advice that these committees and panels gives to Health Canada can be key to ensuring that Canadians get the best possible value out of prescription drugs. It not only needs to be unbiased, it needs to be seen to be unbiased.</p><img src="https://counter.theconversation.com/content/116490/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2016-2019, Joel Lexchin was a paid consultant on two projects: one looking at developing principles for conservative diagnosis (Gordon and Betty Moore Foundation) and a second deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient Oriented Research Support Unit and the St Michael’s Hospital Foundation). He also received payment for being on a panel at the American Diabetes Association, for a talk at the Toronto Reference Library, for writing a brief in an action for side effects of a drug for Michael F. Smith, Lawyer and from the Canadian Institutes of Health Research for presenting at a workshop on conflict-of-interest in clinical practice guidelines. He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare. He receives royalties from University of Toronto Press and James Lorimer & Co. Ltd. for books he has written. </span></em></p>Health Canada must be unbiased and it must be seen to be unbiased – so that Canadians get the best possible value out of prescription drugs.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/1145072019-04-01T15:11:11Z2019-04-01T15:11:11ZFeds are blowing smoke about pot supplies<figure><img src="https://images.theconversation.com/files/266848/original/file-20190401-177184-vndefu.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">A customer holds up his receipt after being the first person to buy cannabis at the SpiritLeaf cannabis store in Kingston, Ont., on April 1, 2019.</span> <span class="attribution"><span class="source">THE CANADIAN PRESS/Lars Hagberg</span></span></figcaption></figure><p>Ontario’s first legal cannabis shops are finally here. One challenge they’ll face is Canada’s nationwide product shortage. That’s despite repeated federal government assurances of ample supplies.</p>
<p><a href="https://theconversation.com/wheres-the-weed-clues-to-canadas-cannabis-shortages-109991">Cannabis shortages</a> certainly seem to exist. <a href="https://news.ontario.ca/mof/en/2018/12/ontario-takes-a-phased-approach-to-cannabis-retail-licensing-due-to-national-supply-shortages.html">Ontario blames them</a> for its initial <a href="https://ottawacitizen.com/news/local-news/province-unlikely-to-meet-promise-of-25-cannabis-shops-by-april-1-analysis-shows">25-store limit</a>. Alberta is also restricting shop licences, while <a href="https://globalnews.ca/news/5035461/quebecs-cannabis-stores-montreal-brossard-openings/">Québec limits shopping hours</a>. </p>
<p>However, federal officials disagree. Bill Blair, the minister leading Cannabis Act implementation, has repeatedly said supplies are “<a href="https://twitter.com/BillBlair/status/1085649196558872577">adequate</a>” and even “<a href="https://twitter.com/BillBlair/status/1090643226254561285">exceed existing demand</a>.”</p>
<p>Similarly, Health Canada last week claimed <a href="https://www.cbc.ca/news/canada/manitoba/cannabis-supply-black-market-1.5074428">“there is not — as some have suggested — a national shortage of supply of cannabis</a>.” It earlier had bragged that January’s dry (smoke-able) cannabis inventories were so large they equalled “<a href="https://twitter.com/GovCanHealth/status/1105984441577558017">19 times the amount sold</a>.”</p>
<p>But the government’s own data shows it’s blowing smoke.</p>
<h2>Low sales</h2>
<p><a href="https://www150.statcan.gc.ca/t1/tbl1/en/tv.action?pid=2010000801&pickMembers%5b0%5d=2.30&pickMembers%5b1%5d=3.1">Statistics Canada numbers</a> show licensed retailers aren’t selling much. Only one-fifth of national cannabis spending from October to December was legal. In January, legal sales <a href="https://www150.statcan.gc.ca/t1/tbl1/en/tv.action?pid=2010000801&pickMembers%5b0%5d=2.30&pickMembers%5b1%5d=3.1">fell five per cent</a>.</p>
<p>Similarly, Health Canada’s <a href="https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/licensed-producers/market-data/supply-demand.html">latest update</a> indicates January sales totalled about 15 tonnes of dry cannabis and cannabis oils (1 tonne = 1,000 kg). That’s for medical and recreational products combined. By contrast, <a href="https://www.cbc.ca/news/business/legal-cannabis-shortage-looms-1.4845816">its estimate</a> implies monthly demand is around 77 tonnes.</p>
<p>Cannabis oils aren’t the problem. Their sales volume rose four per cent, the third consecutive monthly gain.</p>
<p>But dry cannabis sales slid four per cent to 7.1 tonnes. That’s concerning because recreational users <a href="https://theconversation.com/how-canadians-are-buying-cannabis-and-getting-high-now-that-its-legal-111464">prefer dry products</a> to oils. In October and November, dry cannabis captured 72 per cent of recreational sales nationwide. It got 90 per cent in Québec and New Brunswick.</p>
<p>Altogether, just around <a href="https://theconversation.com/scarce-retail-weed-shops-means-most-canadians-still-use-black-market-pot-113503">15 per cent of cannabis sold</a> in Canada is legal. Even provinces with relatively plentiful stores have legal shares of only <a href="https://nationalpost.com/opinion/recreational-cannabis-isnt-the-cash-cow-the-government-hoped-for">about 29 per cent</a>. </p>
<p>Such widespread weakness can’t be solely due to some provinces having “<a href="https://twitter.com/BillBlair/status/1085649196558872577">difficulties</a>” with “<a href="https://twitter.com/BillBlair/status/1090643230184624130">distribution systems</a>,” as Blair has claimed. But neither he nor Health Canada has offered better explanations. That department collects <a href="https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/tracking-system/monthly-reporting-guide-federal.html">extensive industry data</a> but keeps most numbers secret. It publishes only inventory and sales totals. Fortunately, we can learn much from those.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/266635/original/file-20190330-70986-msogor.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/266635/original/file-20190330-70986-msogor.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=399&fit=crop&dpr=1 600w, https://images.theconversation.com/files/266635/original/file-20190330-70986-msogor.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=399&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/266635/original/file-20190330-70986-msogor.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=399&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/266635/original/file-20190330-70986-msogor.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=502&fit=crop&dpr=1 754w, https://images.theconversation.com/files/266635/original/file-20190330-70986-msogor.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=502&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/266635/original/file-20190330-70986-msogor.png?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">
<figcaption>
<span class="caption">Tonnes of cannabis packaged by producers, shipped by producers or sold to consumers, compared to demand, in January 2019. Combines recreational and medical products. Estimated by author from Health Canada data.</span>
<span class="attribution"><span class="source">Michael Armstrong</span></span>
</figcaption>
</figure>
<h2>Falling shipments</h2>
<p>For example, in January retailers sold 5.3 tonnes of recreational dry cannabis, while their inventory decreased 0.5 tonnes. So, they must have received just 4.8 tonnes of new product from producers. (Another 1.8 tonnes went directly from producers to medical clients.)</p>
<p>That implies retailers didn’t sell much dry cannabis in January because they didn’t receive much. January’s dry shipments to retailers were 21 per cent lower than December’s, which were already lower than November’s.</p>
<p>And retailers got little in January because producers processed little in December. Another inventory comparison suggests producers packaged just 6.3 tonnes of dry products that month. That’s only three-quarters of November’s rate. And inadequate to support existing sales.</p>
<p>(It was December’s data that Blair claimed <a href="https://twitter.com/BillBlair/status/1090643226254561285">showed supplies are “sufficient.”</a>)</p>
<p>This wasn’t a temporary shortfall. The average monthly packaging rate from November to January for dry cannabis products was around 7.6 tonnes. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/266636/original/file-20190330-71009-lkm3ty.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/266636/original/file-20190330-71009-lkm3ty.png?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=337&fit=crop&dpr=1 600w, https://images.theconversation.com/files/266636/original/file-20190330-71009-lkm3ty.png?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=337&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/266636/original/file-20190330-71009-lkm3ty.png?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=337&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/266636/original/file-20190330-71009-lkm3ty.png?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=423&fit=crop&dpr=1 754w, https://images.theconversation.com/files/266636/original/file-20190330-71009-lkm3ty.png?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=423&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/266636/original/file-20190330-71009-lkm3ty.png?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=423&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Tonnes of dry cannabis packaged by producers, shipped by producers or sold to consumers, last November, December, and January. Combines recreational and medical products. Estimated by author from Health Canada data.</span>
<span class="attribution"><span class="source">Michael Armstrong</span></span>
</figcaption>
</figure>
<h2>Government smokescreens</h2>
<p>This analysis suggests federal claims of adequate cannabis supplies are mere smokescreens for substantial shortages.</p>
<p>Similarly, Health Canada claiming dry “inventories” were 19 times “sales” is just smoke and mirrors. It’s correct but meaningless.</p>
<p>Those inventories were mostly raw material or work-in-process: unfinished cannabis drying, curing, or awaiting processing. Only 15 per cent was finished product, and less than half of that was at retailers. And existing sales are too weak to be worth targeting.</p>
<p>(Besides, inventory-to-sales ratios indicate little about availability. In <a href="http://www.annualreports.com/HostedData/AnnualReports/PDF/TSX_L.t_2017.pdf">some</a> <a href="https://s2.q4cdn.com/056532643/files/doc_financials/2018/annual/WMT-2018_Annual-Report.pdf">sectors</a>, retailers hold less than two months of inventory.)</p>
<p>Comparing production to demand is more meaningful. January’s dry product packaging was about 8.0 tonnes, enough for perhaps a quarter of dry demand. Combined dry and oil packaging totaled 27 tonnes, about one-third of overall cannabis demand.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/266694/original/file-20190331-177181-y50aoe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/266694/original/file-20190331-177181-y50aoe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/266694/original/file-20190331-177181-y50aoe.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/266694/original/file-20190331-177181-y50aoe.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/266694/original/file-20190331-177181-y50aoe.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/266694/original/file-20190331-177181-y50aoe.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/266694/original/file-20190331-177181-y50aoe.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">Marie Koued becomes the first in line at a Toronto cannabis store on the eve of the opening of Ontario’s first retail weed stores on April 1, 2019.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Chris Young</span></span>
</figcaption>
</figure>
<p>There’s another reason the latter fraction is low. The federal government hasn’t yet legalized cannabis foods and drinks. Those edibles constitute <a href="https://www.cbc.ca/news/politics/cannabis-edibles-regulations-consultation-1.4954116">43 per cent of sales in Colorado, California and Oregon</a>. Their absence here leaves a big gap.</p>
<h2>Stop playing games</h2>
<p>The federal government really must stop playing make-believe about cannabis availability. Nonsensical supply claims raise expectations, and hence frustrations, among businesses and consumers.</p>
<p>Similarly, Health Canada must stop playing hide-and-seek with information. It collects monthly fresh cannabis production and finished product packaging data. It should start reporting them. That clarity would help producers and retailers make better business decisions.</p>
<p>Producers are already making progress. Canada now has <a href="https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/industry-licensees-applicants/licensed-cultivators-processors-sellers.html?hootPostID=1b11ac7d7973eff4c7b5548c1b9ceb7d%22%22">164 licensed sellers</a>, with <a href="https://mjbizdaily.com/reckoning-coming-cannabis-licensed-cultivators-applicants-near-1000-in-canada/">hundreds more</a> reportedly on the way. Total cultivation area <a href="https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/research-data/market/dried.html">rose 20 per cent in December</a> alone. But it takes months for new sites to grow, process and ship cannabis to stores.</p>
<p>Retailers too are finally making progress in Ontario. They’ll <a href="https://montrealgazette.com/opinion/opinion-quebec-should-make-legal-cannabis-more-available-not-less">make legal cannabis more available</a> and therefore <a href="https://theconversation.com/legal-cannabis-vs-black-market-can-it-compete-104915">more competitive with black markets</a>. Given <a href="https://www.lapresse.ca/affaires/economie/quebec/201901/22/01-5212038-la-sqdc-dit-accaparer-35-des-ventes-de-cannabis-au-pays.php">Québec’s results</a>, Ontario’s first shops might average around <a href="https://www.thespec.com/news-story/9245468-how-much-cash-will-legal-pot-shops-generate-/">$1.25 million in monthly sales</a> each. Individual store’s results naturally will depend on location — and on the shortages it encounters. I wish them all the best.</p><img src="https://counter.theconversation.com/content/114507/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Michael J. Armstrong 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>Federal officials have repeatedly claimed cannabis supplies are sufficient. But their own data suggest otherwise.Michael J. Armstrong, Associate professor of operations research, Goodman School of Business, Brock UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1023172018-09-03T13:52:38Z2018-09-03T13:52:38ZDrug ads leave Canadians in the dark about safety risks<figure><img src="https://images.theconversation.com/files/234348/original/file-20180830-195328-wpm5mc.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">The failure of TV ads to explain the safety risks of over-the-counter drugs can leave people in the emergency department with liver damage or psychosis. </span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>When you watch Canadian television, it’s almost inevitable that you’ll come across advertisements for over-the-counter (OTC) drugs — the ones that you can buy without a prescription. </p>
<p>The ads are more than happy to tell you about the benefits — how your pain will be relieved, your skin cleared up, your allergic symptoms vanquished. Safety information in these ads, however, is virtually non-existent. </p>
<p>If you’re quick and have really good eyesight you might catch a message in small print at the bottom of the ad that runs for two to three seconds. It says that to make sure that the drug is right for you should read the label. Missed that message? The other night I missed that message in three different ads.</p>
<p>One of the results is that in the emergency department in Toronto where I work we see alcoholics who have further damaged their liver because they took too much acetaminophen. </p>
<p>We see people with psychotic symptoms because they took too many antihistamines. </p>
<p>There was no warning about these safety problems in the ads. Some of this information was in the label, but any message about reading the label was highly likely to have been missed.</p>
<h2>Health Canada relinquished responsibility</h2>
<p>It wasn’t always this way. Up until the end of February 1997, Health Canada was directly responsible for clearing the scripts for TV ads for OTC drugs. A 1993 review found that approximately one third of these scripts failed to comply with regulatory requirements.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/234349/original/file-20180830-195331-1lfgvut.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/234349/original/file-20180830-195331-1lfgvut.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/234349/original/file-20180830-195331-1lfgvut.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/234349/original/file-20180830-195331-1lfgvut.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/234349/original/file-20180830-195331-1lfgvut.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/234349/original/file-20180830-195331-1lfgvut.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/234349/original/file-20180830-195331-1lfgvut.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">TV ads for over-the-counter medicines tout their health-promoting benefits but explain none of their risks.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>At the start of March 1997, the responsibility for clearing consumer-directed broadcast advertising for OTC drugs was transferred to <a href="https://www.adstandards.com/en/">Advertising Standards Canada</a> (ASC), a national industry association. </p>
<p>Crucially, the role of ASC was only to review the ads, not to regulate them. </p>
<p>Health Canada continued to set minimum standards, but at the same time also stopped adjudicating complaints about ads. </p>
<p>After this transfer of responsibility, there is no public record of any evaluation of the adequacy of the new system in complying with Health Canada’s regulations.</p>
<h2>Agencies regulate themselves</h2>
<p>Despite never having done an evaluation, in August 2006, Health Canada announced its intention to further loosen control over this type of advertising. </p>
<p>Under the <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/advertising-preclearance/recommended-public-attestation-criteria-advertising-preclearance-agencies-canada.html">new proposed system</a>, Health Canada would no longer endorse specific agencies performing these pre-clearance activities. Rather, it would let agencies self-attest that they had the ability to meet these criteria. </p>
<p>In other words, agencies would regulate themselves and the public would have to rely on them being honest. </p>
<p>The equivalent would be for students to “self-attest” that they had not cheated on an exam and for teachers to trust them.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/234343/original/file-20180830-195325-zgr23s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/234343/original/file-20180830-195325-zgr23s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=450&fit=crop&dpr=1 600w, https://images.theconversation.com/files/234343/original/file-20180830-195325-zgr23s.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=450&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/234343/original/file-20180830-195325-zgr23s.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=450&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/234343/original/file-20180830-195325-zgr23s.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=566&fit=crop&dpr=1 754w, https://images.theconversation.com/files/234343/original/file-20180830-195325-zgr23s.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=566&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/234343/original/file-20180830-195325-zgr23s.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=566&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Instructions on an over-the-counter pill bottle are shown in Toronto on Monday, July 7, 2014. Trying to decipher dose instructions written in small print on prescription medication labels can also be a daunting task for people with vision impairment or dimming eyesight due to age.</span>
<span class="attribution"><span class="source">THE CANADIAN PRESS/Graeme Roy</span></span>
</figcaption>
</figure>
<p>ASC itself pointed out the weaknesses in what Health Canada was proposing. It noted that the new system “could…result in the mistaken belief [that agencies possess the requisite knowledge, expertise and systems to perform this function]. This lack of understanding and expertise could lead to review errors that compromise consumer health and safety.”</p>
<h2>Virtually unreadable messages</h2>
<p>Another part of the move to change the oversight of OTC promotion was a 2006 invitational roundtable, sponsored by Health Canada, on the inclusion of risk information in advertising. </p>
<p>At the roundtable, a wide variety of opinions were expressed as to how much safety information should be included in ads. Some participants wanted more detailed information provided, some advocated for “black box” warnings for certain drugs, others felt that labels and inserts should be more user friendly. </p>
<p><a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/regulatory-requirements-advertising/policies-guidance-documents/section-2-21-consumer-advertising-guidelines-marketed-health-products-notice-2007-03-30.html">Health Canada’s position</a> was that there should be a verbal cautionary statement in TV ads, but it was willing to accept visual disclosures — provided they were “clear, visible and of a sufficient duration to be effectively read and understood by consumers.”</p>
<p>What we got was self-attestation with virtually unreadable messages. </p>
<p>People deserve to know about the safety risks of medicines that they buy. It’s time Health Canada took back the regulation of OTC advertising.</p><img src="https://counter.theconversation.com/content/102317/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2015-2018, Joel Lexchin was a paid consultant on three projects: one looking at indication-based prescribing (United States Agency for Healthcare Research and Quality), a second to develop principles for conservative diagnosis (Gordon and Betty Moore Foundation) and a third deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient Oriented Research Support Unit and the St Michael’s Hospital Foundation). He also received payment for being on a panel that discussed a pharmacare plan for Canada (Canadian Institute, a for-profit organization). He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is member of the Foundation Board of Health Action International and the Board of Canadian Doctors for Medicare.</span></em></p>It’s time Health Canada took back the regulation of drug advertising – to protect consumers.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/948882018-04-12T21:28:05Z2018-04-12T21:28:05ZHow Big Pharma deceives you about drug safety<p>The recent decision of a Saskatchewan judge to <a href="https://www.theglobeandmail.com/canada/article-saskatchewan-judge-rejects-proposed-settlement-between-opioid-patients/">reject the proposed settlement between the provinces and Purdue Pharma, the maker of OxyContin,</a> should raise serious questions. </p>
<p>Purdue introduced the prescription drug OxyContin in 1996 and marketed it as safer and less addictive than other opioids. This is now seen by many as the beginning of <a href="https://theconversation.com/uk/search?utf8=%E2%9C%93&q=canadas+opioid+crisis">the opioid crisis in Canada</a>. The settlement in question was meant to compensate patients who were victims of the opioid epidemic and the provinces for some of their additional health-care costs in dealing with the epidemic.</p>
<p>The decision should raise questions not just about how Purdue marketed OxyContin, but also about how Health Canada regulates — or more accurately does not regulate — the promotion of prescription drugs in Canada.</p>
<p>Since at least as far back as the mid-1970s, Health Canada has not fined a single drug company for the way that it promotes prescription drugs. </p>
<p>A reporter for <em>the Toronto Star</em> asked Health Canada why it had never prosecuted drug companies for illegally marketing drugs in Canada despite the same companies being fined for doing so in the United States. </p>
<p>The <a href="https://www.thestar.com/news/canada/2014/06/26/dangers_of_offlabel_drug_use_kept_secret.html">response from Health Canada</a> was that it “has not been made aware of any specific similar issue in Canada and has not received complaints concerning these companies promoting off-label uses of their products in Canada.”</p>
<h2>Regulation by industry</h2>
<p>In theory, the <a href="http://laws-lois.justice.gc.ca/eng/acts/f-27/">Food and Drugs Act</a> and <a href="http://laws.justice.gc.ca/eng/regulations/c.r.c.,_c._870/index.html">its regulations</a> give Health Canada the ability to directly regulate promotion. </p>
<p>In practice, the agency has turned over the day-to-day regulation of promotion to a combination of industry, as represented by its lobbying arm Innovative Medicines Canada (IMC), and an independent external group with strong industry representation, the Pharmaceutical Advertising Advisory Board (PAAB).</p>
<p><a href="http://www.paab.ca/about.htm">The PAAB is governed by a 14-person board</a>, with representatives from five organizations that directly benefit from drug advertising: IMC, BioteCanada, Association of Medical Advertising Agencies, Canadian Association of Medical Publishers and Consumer Health Products Canada.</p>
<p>Its <a href="http://code.paab.ca/">Code of Advertising Acceptance</a> is deeply flawed. </p>
<p>This code requires a “fair balance of risk to benefit” but there is no specific requirement that equal space in the ads be devoted to harms and benefits, and there is no provision for the font size used to describe benefits and harms to be equal in size. </p>
<p>The generic name does not have to be used each time that the brand name is given, despite evidence that <a href="http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1000352">use of the generic name leads to better prescribing</a>. </p>
<p>The most serious penalty that the PAAB can impose where <a href="http://code.paab.ca/make-an-appeal.htm">“information may cause inappropriate product use or constitutes an imminent and/or significant health hazard”</a> is that the head of the organization may require letters of correction, published notices or the immediate withdrawal of the advertisement. </p>
<h2>‘Drug abuse is not a problem…’</h2>
<p>One example of how Purdue misled Canadian doctors about OxyContin was an ad that appeared in <em>Canadian Family Physician</em> in 2000. </p>
<p>The ad featured the World Health Organization “pain ladder” — <a href="http://www.who.int/cancer/palliative/painladder/en/">a guideline for administering the right drug in the right dose at the right time for cancer pain relief</a> — that Purdue had adapted. New drugs were added to the ladder as part of the adaptation, one of which was oxycodone, the generic name for OxyContin, and there was no mention that the original pain ladder was only for people with cancer. </p>
<p>The same ad also had the statement that, “drug abuse is not a problem in patients with pain for whom the opioid is appropriately indicated.” </p>
<p>The provenance for that quote can be traced back to a <a href="http://www.nejm.org/doi/pdf/10.1056/NEJM198001103020221">five-sentence letter in <em>the New England Journal of Medicine</em></a> in January 1980. </p>
<p>The patients referred to in the letter suffered from acute pain, not chronic pain, were in hospital, not outpatients, and there was no long-term follow-up. </p>
<p>The ad had been approved by the PAAB.</p>
<h2>Health Canada an advisor</h2>
<p>The Oct. 18, 2016, issue of the <em>Canadian Medical Association Journal</em> had an ad for another opioid, Targin, also made by Purdue. </p>
<p>The ad prominently featured the statement: “Demonstrated reduced drug liking relative to oxycodone, when administered intranasally or intravenously.” Drug liking refers to the risk that a drug will be abused because of its addictive potential.</p>
<p>Below this statement, in barely visible print, was the acknowledgement that “the likely clinical significance of these results has not yet been established.” </p>
<p>The ability of companies to insert claims where the clinical significance is unknown is allowed by the PAAB code. How much reduction in liking was observed was not stated. </p>
<p>Intranasal and intravenous administration was tested because those are routes likely to be used by recreational drug users. Targin is only available in an oral formulation, but there was nothing in the ad about potential for abuse by people who had been legitimately prescribed this dosage form. </p>
<p>Buried deep in the fine print was the warning about “addiction, abuse and misuse.” This ad was also approved by the PAAB. </p>
<p>In 2012, OxyContin was replaced by OxyNeo, a new formulation that couldn’t be crushed and injected. The following year Purdue <a href="http://imsbrogancapabilities.com/YIR_2013_FINAL">spent more than $3 million promoting OxyNeo</a>, took out 143 pages of advertising in Canadian medical journals and its sales representatives made 17,000 office visits to doctors.</p>
<p>When the PAAB was subjected to public criticism in an academic forum, the organizers of the forum, of whom I was one, were <a href="http://shpm.info.yorku.ca/files/2018/04/Joel-Lexchin-Letter-of-complaint-from-Rosser.pdf">asked to send an apology to all of the audience members</a>, an apology that would be first reviewed by the organization’s lawyer.</p>
<p>Health Canada presumably approves of how the PAAB operates since it acts as an adviser to the organization.</p>
<h2>No information on drug harms</h2>
<p>Despite the visibility of journal ads, the amount spent on them is dwarfed by the amount spent on visits by sales representatives. In 2016, pharmaceutical companies in Canada spent <a href="http://imsbrogancapabilities.com/YIR_2016_FINAL/mobile/index.html">$12.5 million on ads versus more than $400 million on sales reps</a>. </p>
<p>The actions of these men and women are regulated through the Code of Ethical Practices of IMC. The code states that: “Members must provide full and factual information on products, without misrepresentation or exaggeration. Statements must be accurate and complete. They should not be misleading, either directly or by implication.” </p>
<p>This claim was tested in 2009-2010 in a <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3785667/">project lead by Dr. Barbara Mintzes</a>, then a faculty member in population and public health at the University of British Columbia, that I was involved in. </p>
<p>We asked general practitioners in Vancouver and Montreal who saw sales representatives to fill out questionnaires after each visit to record what they heard. </p>
<p>Claims about benefits of drugs were made twice as often as the harms from those drugs were discussed. </p>
<p>There was no oral or written information about harms between 36 to 40 per cent of the time. </p>
<p>Contraindications to use of the drug were mentioned about 15 per cent of the time. And for serious adverse side effects it was even worse — the sales reps talked about them only five to six per cent of the time.</p>
<h2>Penalties are lunch money</h2>
<p>The validity of complaints about code violations is decided by the Industry Practices Review Committee (IPRC). The permanent members of the IPRC are two company representatives, two external health-care professionals all appointed by the IMC Board of Directors, a representative appointed by the IMC president and IMC’s general counsel. </p>
<p>The maximum financial penalty after a fourth violation in a 12-month period is $100,000. After the third violation, the chief executive officer of the company is required to appear before the R&D Board of Directors to provide a detailed explanation of the violations and a comprehensive written action plan to ensure remediation. </p>
<p>When companies are spending <a href="http://imsbrogancapabilities.com/YIR_2016_FINAL">upwards of $14 million promoting a single product</a>, $100,000 is lunch money.</p>
<p>The way in which companies promote their products should be no surprise; they are in the business of making a profit for their shareholders. </p>
<p>What is surprising is that Health Canada condones their marketing practices. It’s time for that to change.</p><img src="https://counter.theconversation.com/content/94888/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2015-2017, Joel Lexchin was a paid consultant on two projects: one looking at indication-based prescribing (United States Agency for Healthcare Research and Quality) and a second deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient Oriented Research Support Unit and the St Michael’s Hospital Foundation). He also received payment for being on a panel that discussed a pharmacare plan for Canada (Canadian Institute, a for-profit organization). He is currently a member of research groups that are receiving money from the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is member of the Foundation Board of Health Action International.</span></em></p>Prescription drugs are policed by industry and Health Canada has never prosecuted a drug company for illegally marketing a drug.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University and Associate Professor of Family and Community Medicine, University of TorontoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/933432018-03-14T22:51:34Z2018-03-14T22:51:34ZPharmacare and the chaotic world of Canadian drug prices<p>The cost of a life-saving drug to treat cystinosis — a rare disease affecting probably 100 people across Canada — is soon to rise from <a href="http://www.cbc.ca/news/health/second-opinion-procysbi-cystagon-march10-1.4570152">$10,000 per year to more than $300,000 annually</a>.</p>
<p>The new form of the drug, Procysbi, contains the same active ingredient as the old form of the drug, Cystagon. It differs only in that it contains a new coating, enabling a slower release of chemicals into the body. </p>
<p><a href="http://www.gazette.gc.ca/rp-pr/p1/2017/2017-12-02/html/reg2-eng.html">Reforms to the Patented Medicine Prices Review Board (PMPRB)</a>, a federal agency that sets a maximum introductory price for new patented drugs, could help rein in this type of increase. </p>
<p>But a coalition of patient groups, some partially funded by drug companies, want Canada’s health minister and Health Canada to <a href="https://www.newswire.ca/news-releases/canadian-patient-groups-call-on-federal-health-minister-to-halt-the-process-examining-proposed-amendments-to-the-patented-medicine-regulations-pending-constructive-consultations-674144623.html">stop this reform process</a>. They argue that lowering drug prices in the manner proposed could limit access to new drugs. </p>
<p>The drug companies are backing them up. </p>
<h2>Canadians pay the price</h2>
<p><a href="http://healthydebate.ca/2018/03/topic/canada-drug-prices">According to Pamela Fralick</a>, the CEO of Innovative Medicines Canada (IMC), the lobby group representing the multinational subsidiaries operating in Canada: “The proposed changes would negatively affect patients by slowing and limiting access to new, life-saving medicines and vaccines, and will have consequences for investment and employment in Canada’s life science sector.”</p>
<p>IMC and its predecessors have been making the same type of veiled threat since the early 1970s, when Manitoba introduced its public drug formulary, a list of drugs the province would cover. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/210172/original/file-20180313-30958-lqf885.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/210172/original/file-20180313-30958-lqf885.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/210172/original/file-20180313-30958-lqf885.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/210172/original/file-20180313-30958-lqf885.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/210172/original/file-20180313-30958-lqf885.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/210172/original/file-20180313-30958-lqf885.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/210172/original/file-20180313-30958-lqf885.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=503&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">With a national pharmacare plan, all Canadians would benefit from lower drug prices.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>While there are drugs that are not sold in Canada, the reason is the relatively small Canadian market, not the price. </p>
<p>In fact, when it comes to paying for prescription drugs, <a href="http://dx.doi.org/10.1787/health_glance-2017-en">only the United States and Switzerland outspend Canada</a> on a per capita basis out of 31 industrialized countries in the Organization for Economic Cooperation and Development. </p>
<p>There are now <a href="http://www.pmprb-cepmb.gc.ca/view.asp?ccid=1334">19 drugs on the Canadian market that cost $50,000 or more per year</a>, compared to just six a decade ago. </p>
<p>And, contrary to what IMC claims and what the patient groups seem to believe, <a href="http://www.pmprb-cepmb.gc.ca/view.asp?ccid=1334">only one in 10 new drugs are actually major therapeutic improvements</a>.</p>
<h2>Increase of 3,000 per cent</h2>
<p>The dramatic rise in the cost of treating cystinosis — a genetic disease that causes kidney damage — reflects the dysfunctional nature of the way Canada controls drug prices. </p>
<p>Up until now, the treatment has been a product called Cystagon that must be vetted by Health Canada on a patient-by-patient basis since it’s not approved for sale in Canada. Now the newer version of the drug, Procysbi, made by Horizon Pharma — and taken twice instead of four times daily — is being marketed in Canada. </p>
<p>With the advent of Procysbi, the cheaper Cystagon will no longer be available to Canadian patients. Under the current rules enforced by the PMPRB, Procysbi is treated as a “breakthrough drug,” which is why the 3,000 per cent price increase was permitted.</p>
<p>Again — the only difference between Cystagon and Procysbi is the latter has a special coating enabling its release into the body more slowly. </p>
<p>All of the basic research and development of Procysbi was <a href="http://www.cbc.ca/news/health/second-opinion-procysbi-cystagon-march10-1.4570152">financed by patient groups, not drug companies</a>. Horizon Pharma has not publicly offered any reason for the price it plans to charge. The company is going to offer the drug for free for a limited time, but what happens when that option ends? </p>
<p>This isn’t the first time there’s been sticker shock about drug prices in Canada. In September 2017, the PMPRB ordered <a href="http://www.cbc.ca/news/health/solaris-pmprb-1.4310249">Alexion Pharmaceuticals to lower the $700,000 annual cost of Soliris</a>, used in the treatment of rare blood disorders. </p>
<p>The pan-Canadian Pharmaceutical Alliance, a coalition of provincial and federal drug plans, bargains with companies for lower prices and is in negotiations with Horizon Pharma. But even if it can secure a discount, that will only apply to what provincial drug plans pay. </p>
<p>Private drug plans and people paying out of pocket, assuming anyone could actually afford Procysbi, will not get the discount.</p>
<h2>National pharmacare a solution</h2>
<p>A <a href="https://theconversation.com/canadian-pharmacare-is-closer-to-becoming-a-reality-92646">national pharmacare plan</a> could help to bring some order to the chaotic world of Canadian drug prices. Everyone in the country would be covered under a public plan and benefit from the lower drug prices that would be achieved. </p>
<p>Pharmacare doesn’t necessarily mean that drugs will sell for pennies. But based on the experience in other countries, we will be much better off. </p>
<p>If companies don’t like the price being offered, then they could still try to sell their drugs to those who could afford them, but the market would typically be very small, encouraging the companies to lower prices. </p>
<p>However, Finance Minister Bill Morneau doesn’t seem interested in a universal pharmacare plan, <a href="http://www.richmond-news.com/cmlink/gmg-glacier-media-group/2.2062/critics-call-for-morneau-s-ouster-from-pharmacare-file-over-remarks-about-study-1.23189183">preferring to try to fill gaps and add to the patchwork</a> in the existing system, although now he seems to be backing off from his initial comments.</p>
<p>Perhaps people with cystinosis should ask Morneau to cover their costs.</p><img src="https://counter.theconversation.com/content/93343/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2015-2017, Joel Lexchin was a paid consultant on two projects: one looking at indication-based prescribing (United States Agency for Healthcare Research and Quality) and a second deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient Oriented Research Support Unit and the St Michael's Hospital Foundation). He also received payment for being on a panel that discussed a pharmacare plan for Canada (Canadian Institute, a for-profit organization). He is a principle investigator on projects funded by the Canadian Institutes of Health Research and the Australian National Health and Medical Research Council. He is member of the Foundation Board of Health Action International.</span></em></p>The cost of a life-saving drug in Canada is rising by 3,000 per cent. A national pharmacare plan could bring order to this chaotic world of Canadian drug prices.Joel Lexchin, Board member of Canadian Doctors for Medicare, Professor Emeritus of Health Policy and Management, York University and Associate Professor of Family and Community Medicine, University of TorontoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/912272018-02-06T23:55:44Z2018-02-06T23:55:44ZShould Health Canada rely on foreign assessment of new drugs?<figure><img src="https://images.theconversation.com/files/204940/original/file-20180205-14064-1jbjmlo.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Health Canada is proposing a new system to fast-track urgent drugs for children, the elderly and those with serious or life-threatening conditions. This would rely on decisions made by regulators in other jurisdictions.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>Health Canada is proposing a new way of allowing certain drugs that Canadians need into the country. </p>
<p>Instead of conducting a detailed review of the evidence — to make sure the product meets acceptable standards for safety, efficacy and quality of manufacturing — the regulator would rely on decisions made by drug regulators in a small number of other regions, including the United States and Europe. </p>
<p>In a <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/use-foreign-sourced-reference-product-as-canadian-reference-product.html">notice about this proposal</a>, Health Canada explicitly states that it would only “conduct a cursory clinical review of the submission package.”</p>
<p>These are drugs that are on an “urgent public health needs” list, particular formulations for children, the elderly and those made available to individuals with serious or life-threatening conditions through Health Canada’s <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/drugs/special-access-programme-drugs-1.html">Special Access Programme</a>.</p>
<p>They are drugs that would not otherwise make it onto the Canadian market. Usually, this is because the company making the product doesn’t think enough people will use the drug to justify the cost of getting it through the regulatory system and then marketing it.</p>
<p>Is this a good idea? Should Canada rely on what regulators in the United States or Europe have to say about drugs? </p>
<p>On the surface it seems fine. The standards these countries use are comparable to those in Canada. But there are some issues that Health Canada’s announcement does not address, and some information that raises serious questions about this proposal.</p>
<h2>Increased exposure to harms</h2>
<p><a href="http://dx.doi.org/10.1136/bmjopen-2016-014582">One study from the U.S.</a> has examined what would happen if a policy similar to Health Canada’s was adopted there. </p>
<p>The study lists 110 new drugs that were approved in Europe and/or Canada before the United States between 2001 and 2010. A number of those drugs had been examined by the U.S. Food and Drug Administration and rejected for safety reasons. Two of the drugs approved in Europe were subsequently withdrawn because of unacceptable side effects. </p>
<p>The conclusion of the study was that “reciprocal approval legislation would most likely benefit only a small number of U.S. patients receiving treatment for rare diseases, and the benefit may be somewhat mitigated by an increased exposure to harms.”</p>
<p>Even when drugs are approved in both the U.S. and Europe, there are <a href="https://www.ncbi.nlm.nih.gov/pubmed/21537038">still differences in what the regulators allow</a>. </p>
<p>Forty-two cancer drugs were approved by both regulators for 100 different uses, but in 47 cases there were differences in those uses. For 19 of these, the difference was that one agency approved a specific use, whereas the other agency did not. In 10 cases, there were discrepancies in therapeutic indications between Europe and the U.S. that were considered clinically relevant.</p>
<p>This raises the question: If there is a drug that is not marketed in Canada but is available in both Europe and the U.S., which foreign evaluation will Health Canada use?</p>
<h2>National therapeutic cultures</h2>
<p>Health Canada’s proposal also ignores the reality that drug regulation is more than just technical specifications. </p>
<p>Regulatory frameworks are a reflection of the therapeutic culture that has developed in an individual country. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/204935/original/file-20180205-14111-1wcoraq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/204935/original/file-20180205-14111-1wcoraq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=389&fit=crop&dpr=1 600w, https://images.theconversation.com/files/204935/original/file-20180205-14111-1wcoraq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=389&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/204935/original/file-20180205-14111-1wcoraq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=389&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/204935/original/file-20180205-14111-1wcoraq.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=489&fit=crop&dpr=1 754w, https://images.theconversation.com/files/204935/original/file-20180205-14111-1wcoraq.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=489&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/204935/original/file-20180205-14111-1wcoraq.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=754&h=489&fit=crop&dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Drug regulation decisions depend on national values as well as clinical evidence.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Therapeutic cultures arise from networks of individuals and organizations that produce regulatory policy, determine testing standards and ultimately decide on market access for new drugs. </p>
<p>It would be a serious mistake to think that national networks are the same across different countries. It misses the point that drug regulation exists at the intersection of values, science, medical culture, patient needs and expectations and politics.</p>
<h2>Inadequate consultation time</h2>
<p>Health Canada is also in the process of <a href="http://gazette.gc.ca/rp-pr/p1/2017/2017-12-09/html/reg3-eng.html">developing regulations that would allow it to release detailed information about the safety and efficacy of the clinical trials</a> that companies submit when they want to market a new drug. This type of information allows doctors, patients and researchers to look at the studies on their own. </p>
<p>If Health Canada relies on the decisions of foreign regulators, would it be able to release the same type of information? If not, that would mean no independent evaluations.</p>
<p>Finally, Health Canada is doing <a href="https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/use-foreign-sourced-reference-product-as-canadian-reference-product.html">a telephone consultation</a> on its proposal on this Friday, Feb. 9, 2018. The announcement about that consultation was not issued until Jan. 31. </p>
<p>Nine days is an unacceptable amount of time to allow people to develop informed opinions on this important issue.</p><img src="https://counter.theconversation.com/content/91227/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Joel Lexchin receives funding from CIHR and the Australian National Health and Medical Research Council. He is affiliated with the Foundation Board of Health Action International. In 2015-2017, he was a paid consultant on two projects: one looking at indication-based prescribing (United States Agency for Healthcare Research and Quality) and a second deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient Oriented Research Support Unit and the St Michael's Hospital Foundation). He also received payment for being on a panel that discussed a pharmacare plan for Canada (Canadian Institute, a for-profit organization).</span></em></p>Health Canada is proposing to allow some prescription drugs into the country with only ‘cursory clinical review.’ Here’s why we should be worried.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University and Associate Professor of Family and Community Medicine, University of TorontoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/895262018-01-09T22:22:26Z2018-01-09T22:22:26ZYour prescription drugs are about to become less safe if Health Canada has its way<figure><img src="https://images.theconversation.com/files/201075/original/file-20180107-26139-92jxri.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Health Canada's intention to increase the fees drug makers pay for the drug approval process threatens to compromise drug safety and the health of the Canadian public. </span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>In a little-noticed announcement in October 2017, <a href="https://www.canada.ca/en/health-canada/programs/consultation-fee-proposal-drugs-medical-devices/drug-medical-device-fee-change-proposal.html">Health Canada signaled its intention</a> to raise the fees that drug makers will have to pay when they want to get a new medication on the market. </p>
<p>These user fees currently fund about 50 per cent of Health Canada’s operating budget for regulating prescription drugs. Health Canada wants to increase that to 90 per cent. In addition, it will rebate 25 per cent of that fee if it fails to review new drug applications within an established period of time.</p>
<p>On the surface, charging companies for public services seems to make sense. After all, riders on public transit help pay for some of the costs. </p>
<p>However, there are significant differences. Transit riders are individuals with little power to influence the transit agency. </p>
<p>The same is not the case when it comes to drug companies and regulatory agencies. The Transportation Safety Board of Canada that investigates accidents is not funded by the companies that own the planes and trains. So why is there a different approach when it comes to drug companies and Health Canada?</p>
<p>As a former professor of health policy and a long-time pharmaceutical policy researcher, I would argue that these increased user fees in fact compromise Health Canada’s principal mandate: To protect the public’s health.</p>
<h2>Safe drugs or industry profits?</h2>
<p>Prior to the introduction of user fees in 1994, Health Canada was solely funded by tax dollars. Its main relationship was to the public. </p>
<p>However, since the advent of user fees, Health Canada has a new funder: The pharmaceutical industry. </p>
<p>The public’s primary concern is to have safe and effective drugs. But the primary goal of the pharmaceutical industry is to get its products through the approval system as quickly as possible, and to sell those products to as wide an audience as possible.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/201078/original/file-20180107-26169-104381t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/201078/original/file-20180107-26169-104381t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/201078/original/file-20180107-26169-104381t.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/201078/original/file-20180107-26169-104381t.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/201078/original/file-20180107-26169-104381t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/201078/original/file-20180107-26169-104381t.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/201078/original/file-20180107-26169-104381t.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">Research shows that faster drug reviews lead to more drug safety problems.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>Shortly after Health Canada introduced user fees, a senior official at the agency issued a memo in which he said: <a href="https://www.policyalternatives.ca/sites/default/files/uploads/publications/National_Office_Pubs/transparency.pdf">“The client is the direct recipient of your services. In many cases this is the person or company who pays for the service.”</a> The one-page document focused on service to industry and relegated the public to the secondary status of “stakeholder” or “beneficiary.”</p>
<h2>Faster drug approvals, more safety warnings</h2>
<p>The introduction of user fees in Canada in 1994 was associated with a decrease in the time taken for drugs to get through the review process and onto the market. This means drugs now spend longer on the market under patent protection and produce more profits for drug companies. </p>
<p>Health Canada has explicitly denied any relationship between how quickly it reviews drugs and user fees. But <a href="http://health.gradstudies.yorku.ca/files/2018/01/Cost-recovery-review-times_Joel-Lexchin.pdf">a 1998 document clearly states</a>: “Fee regulations would be amended to make this link [between fees and review performance] as soon as possible after the government determines the best way to proceed.” </p>
<p>Even though it’s often argued that faster drug approval is important to get new drugs to patients more rapidly, there is no evidence of a benefit to public health and considerable evidence of harm. </p>
<p>Most new drugs approved in Canada are no more effective and no safer than existing alternatives. Between 2010 and 2016, <a href="http://www.pmprb-cepmb.gc.ca/view.asp?ccid=1334">only 10.6 per cent of new patented drugs were classified as a substantial improvement or a breakthrough</a>. </p>
<p>While speeding up drug approval benefits industry, faster reviews lead to more safety problems once drugs are on the market in Canada. Drugs that get approved in a 300-day review process have about a <a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1377415">one in five chance of having a serious new safety warning issued once they are on the market</a>. If drugs are approved in 180 days, that probability rises to a one in three chance. </p>
<h2>Rigid timelines, missed safety signals</h2>
<p>Similarly, there are concerns that tying decisions about new drug applications to rigid time lines can have an impact on safety. <a href="http://www.nejm.org/doi/full/10.1056/NEJMsa0706341#t=article">Products approved within 60 days of the Food and Drug Administration’s (FDA) mandated deadline</a> in the United States were five times more likely to be withdrawn from the market for safety reasons and four times to carry a serious safety warning than drugs approved at other times. </p>
<p>One hypothesis for why this might have occurred is the pressure put on FDA reviewers as the deadline approached, leading to missed safety signals.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/201076/original/file-20180107-26157-12vzptb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/201076/original/file-20180107-26157-12vzptb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/201076/original/file-20180107-26157-12vzptb.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/201076/original/file-20180107-26157-12vzptb.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/201076/original/file-20180107-26157-12vzptb.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/201076/original/file-20180107-26157-12vzptb.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/201076/original/file-20180107-26157-12vzptb.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 introduction of user fees for drug approval in 1994 has turned Health Canada’s process into a service for the pharmaceutical industry, with the public as a mere stakeholder.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>When user fees came up for renewal in 2007 in the U.S., <a href="https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0ahUKEwjF6_6jvcvYAhUSxWMKHRsMAXwQFggrMAA&url=https%3A%2F%2Fwww.pharmamedtechbi.com%2F%7E%2Fmedia%2FImages%2FPublications%2FArchive%2FThe%2520Pink%2520Sheet%2F69%2F016%2F00690160007%2Fpdufa_open_letter.pdf&usg=AOvVaw1XiEcJI-fSkufrnoqrH71I">22 prominent American commentators opposed re-authorization</a> — including Marcia Angell, a former editor of the New England Journal of Medicine, Richard Crout, a former director of the Bureau of Drugs in the FDA, and Phillip Lee, a former assistant secretary of health. </p>
<p>Instead they called for increased government funding in order to allow the FDA to undertake its responsibilities free from any apparent conflict of interest.</p>
<h2>A mandate to protect public’s health</h2>
<p>User fees create a client-service provider relationship that is at odds with Health Canada’s principal mandate to protect the public’s health. </p>
<p>Evidence of a poorer safety profile for drugs approved faster should serve as a warning against excessive pressure on reviewers exercising due diligence. </p>
<p>Drug approvals must be independent of pressure from industry for service provision.
This can be achieved by a regulatory system funded fully through tax revenues.</p>
<p>Instead of allowing industry even greater influence over its activities, Health Canada should be calling for a return to complete funding from parliamentary appropriations.</p><img src="https://counter.theconversation.com/content/89526/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>In 2015-2017, Joel Lexchin was a paid consultant on two projects: one looking at indication-based prescribing (United States Agency for Healthcare Research and Quality) and a second deciding what drugs should be provided free of charge by general practitioners (Government of Canada, Ontario Supporting Patient Oriented Research Support Unit and the St Michael’s Hospital Foundation). He also received payment for being on a panel that discussed a pharmacare plan for Canada (Canadian Institute, a for-profit organization). He is member of the Foundation Board of Health Action International. He is currently part of teams of researchers that are being funded by the Canadian Institutes of Health Research and by the Australian National Health and Medical Research Council.</span></em></p>Health Canada proposes to increase fees to the pharmaceutical industry for prescription drug approval. This will compromise drug safety and is a risk to the health of the Canadian public.Joel Lexchin, Professor Emeritus of Health Policy and Management, York University and Associate Professor of Family and Community Medicine, University of TorontoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/879062017-12-13T23:53:37Z2017-12-13T23:53:37ZHave you tested your home for cancer-causing radon gas?<figure><img src="https://images.theconversation.com/files/198962/original/file-20171213-27597-5vhl46.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Radon gas is the leading cause of lung cancer in non-smokers. Children are most at risk of exposure in homes, especially during the winter months.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>Back in 2013, in my first winter in my newly renovated Calgary home, I spent $45 on a radon testing kit. </p>
<p>This was a logical move. I am an assistant professor in the Cumming School of Medicine at the University of Calgary, a cancer researcher and, above all, a radiation biologist specialising in the impact of radiation on DNA. </p>
<p>I know that <a href="http://www.cancer.ca/en/prevention-and-screening/be-aware/harmful-substances-and-environmental-risks/radon/?region=bc">radon is the leading cause of lung cancer</a> after cigarette smoking and that it causes up to 4,000 new lung cancer cases per year in Canada, <a href="http://cmajopen.ca/content/5/3/E540.full.pdf+html">more than 300 of them in Alberta</a>.</p>
<p>That same winter of 2013, I challenged several dozen of my colleagues — cancer researchers and physicians — <a href="https://www.ucalgary.ca/utoday/issue/2014-01-21/calgary-cancer-researchers-volunteer-test-their-homes-radon">to test their homes for radon gas</a>. While my home seemed to be safe, many of my colleagues were not so lucky. They learned their homes contained radon levels far exceeding safe exposure. </p>
<p>In the years that followed, my laboratory performed a study recruiting people as “citizen scientists” to test their homes for radon. We tested more than 2,300 houses in southern Alberta. </p>
<p>The results, published earlier this year, were staggering: <a href="http://cmajopen.ca/content/5/1/E255.full">One in eight homes exceeded Health Canada’s acceptable radon level</a>. Surprisingly, we also found that newer houses have the biggest radon problem.</p>
<p>As a society, we have a well-recognised problem with environmentally-induced cancers. Testing your home for radon gas is an effective prevention strategy and radon is one of the most easily eradicated causes of lung cancer. The problem is most people do not know this. </p>
<h2>What is radon gas?</h2>
<p>Radon is a radioactive, invisible and odourless gas that comes from the natural breakdown of radium in the soil. It can seep into a building through foundation cracks and other openings. Mostly it seeps through the basements of homes, schools and workplaces. It can affect any Canadian building, both old and new, in nearly all inhabited geographical regions. </p>
<p>The first major connection between radon gas and lung cancer was made in the 1970s, after <a href="http://www.personalhealthnews.ca/news/learning-from-the-past-reflecting-on-the-radon-tragedy-in-elliot-lake">Canadian uranium miners in Elliot Lake</a> were found to have unusually high lung cancer rates. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/198702/original/file-20171212-9426-jufz2t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/198702/original/file-20171212-9426-jufz2t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/198702/original/file-20171212-9426-jufz2t.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/198702/original/file-20171212-9426-jufz2t.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/198702/original/file-20171212-9426-jufz2t.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/198702/original/file-20171212-9426-jufz2t.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/198702/original/file-20171212-9426-jufz2t.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">Radon causes up to 4,000 new lung cancer cases in Canada each year.</span>
<span class="attribution"><span class="source">(Shutterstock)</span></span>
</figcaption>
</figure>
<p>It is now known that long-term exposure to <a href="http://www.sciencedirect.com/science/article/pii/S1568786414000251?via%3Dihub">radon gas causes severe damage to our DNA</a>, leading to genetic mutations that can drive our cells towards cancer. <a href="http://www.cancer.ca/en/prevention-and-screening/be-aware/harmful-substances-and-environmental-risks/radon/?region=on">Radon is the number one cause</a> of lung cancer in non-smokers. </p>
<p>There are hundreds of patients in Alberta who have never smoked a day in their life, now dealing with lung cancer. This is a major public health concern. With universal testing and mitigation, radon-induced lung cancer is completely preventable. </p>
<p>Conservative estimates indicate that <a href="http://cmajopen.ca/content/5/1/E255.full">$17 million a year</a> in health-care costs could be saved by avoiding radon-induced cancers, in Alberta alone. This is in addition to the reduction of human suffering.</p>
<p>Being a smoker and living in a home with radon gas puts you at an even higher risk, with a one-in-four chance of developing lung cancer. It is uncertain at this point what percentage of smokers may have avoided cancer had they not also been exposed to radon.</p>
<h2>How to ‘Evict Radon’ from your home</h2>
<p>A 2014 Canadian Cancer Society survey found that <a href="https://www.cancer.ca/en/about-us/for-media/media-releases/national/2014/radon-survey/?region=on">96 per cent of Canadians have not tested their homes for radon gas</a>. Unfortunately, you cannot know if your home is affected unless you test it. </p>
<p>Health Canada offers guidance on how to test homes. The website suggests <a href="https://www.canada.ca/en/health-canada/services/environmental-workplace-health/radiation/radon/radon-frequently-asked-questions.html#test">using a long-term exposure test</a> for a minimum of three full winter months (90 days or more) between October and April. This is the time of year when we, especially Canadians, spend the most time indoors. It is also when radon in our homes, schools and workplaces will peak.</p>
<p>Today, a long-term “alpha track” radon gas test kit will run for about $60 (including cost of the device, postage and lab fees). </p>
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<p>Our lab’s radon testing campaign — now called “<a href="http://evictradon.ca">Evict Radon</a>” — has expanded throughout Alberta. The aim is to understand what specific home metric(s) actually correspond to a higher radon reading — so we can develop innovative solutions. </p>
<p>In just a single month, more than 6,000 Albertans have signed up, and the study remains open until the end of January 2018. Evict Radon has been an incredible success story, and is making Albertans leaders in radon awareness for Canada.</p>
<p>Health Canada also offers information on home remediation and pegs the cost of remediation between $1,500 and $3,000, although this can be less depending upon how radon is entering the home. </p>
<p>In some cases, where the home has radon levels only slightly higher than the limit of 200 Bq/m3, very cheap to free steps can be taken to reduce levels into a safer range.</p>
<p>When mitigating, it is important to choose a knowledgeable professional — someone with <a href="http://c-nrpp.ca/">Canadian National Radon Proficiency Program (C-NRPP) certification</a> — as a lot of building science expertise is required to effectively reduce radon.</p>
<p>While my own home tested below Canada’s maximum acceptable limit for radon gas, my sister’s house was not so lucky. Thankfully, she was quickly able to mitigate her home very effectively using a process called sub-slab depressurization — essentially preventing radon from entering the property in the first place and making it safe for her and her young family.</p>
<h2>Children most at risk</h2>
<p>In Canada, there has been a low-level awareness of the radon issue for some time.
The science has advanced now to the point where we know it is a major public health issue, and one that is very preventable. </p>
<p>Based on this science and the motivation of law makers to preserve health, the first ever <a href="https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0ahUKEwjk8ZS6pobYAhXj5oMKHSnYA_MQFggvMAA&url=http%3A%2F%2Fwww.assembly.ab.ca%2FISYS%2FLADDAR_files%2Fdocs%2Fbills%2Fbill%2Flegislature_29%2Fsession_3%2F20170302_bill-209.pdf&usg=AOvVaw0oZ8e4uQs18UbaBDbxMif2">Albertan Radon Awareness and Testing Act</a> (Bill 209) has passed third reading within the legislature and now only awaits royal assent. </p>
<p>When it comes into effect within the next year, this act will make it mandatory for childcare facilities to ensure our children are not exposed to radon. This is critical, as <a href="http://www.mdpi.com/1660-4601/10/5/1916">our children remain the most at risk from radon exposure</a> over their lifetimes. </p>
<p>Indeed, radon awareness is advancing faster and faster every year. I imagine we will reach a point within the next five to 10 years when people will simply consider radon testing normal — while preparing a house for sale or after a major home renovation. </p>
<p>I hope that, a generation from now, Canadians are no longer walking into cancer clinics to be told they have lung cancer (with all the heartache, pain and worry that entails) from an entirely preventable source and one that takes so little to test and evict from our lives. </p>
<p>Let’s all work together to <a href="http://evictradon.ca">Evict Radon</a>.</p><img src="https://counter.theconversation.com/content/87906/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The laboratory of Dr. Aaron Goodarzi receives funding from the following organizations (all are not-for-profit scientific funding agencies or charities): the Canadian Institutes of Health Research, the National Science and Engineering Research Council, the US Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS) Foundation, and the Alberta Real Estate Foundation. Dr. Goodarzi does NOT receive any personal remuneration for any radon advocacy, and has no financial relationship with anyone in the radon testing or mitigation industry. The University of Calgary Conjoint Health Research Ethics Board has approved the Evict Radon research study. (Study Ethics ID = REB17-2239) </span></em></p>Radon is a radioactive gas that seeps into buildings through foundation cracks. It is the leading cause of lung cancer in non-smokers. And it only costs around $60 to test your home.Aaron Goodarzi, Assistant Professor and Canada Research Chair for Radiation Exposure Disease, University of CalgaryLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/846642017-09-27T23:30:49Z2017-09-27T23:30:49ZEgg donors and surrogates need high-quality care<figure><img src="https://images.theconversation.com/files/187876/original/file-20170927-24212-1vu4go3.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=496&fit=clip" /><figcaption><span class="caption">Egg donors, sperm donors and surrogates are critical participants and patients in the use of reproductive technologies - so why are their rights and heath repeatedly overlooked?</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>Health Canada recently sought public input into new regulations for the use of assisted human reproduction. The consultation process covered everything from in-vitro fertilization (IVF) to egg and sperm donation and surrogacy.</p>
<p><a href="https://www.canada.ca/en/health-canada/programs/consultation-assisted-human-reproduction/document.html#a1">The consultation document</a> prioritizes the health and safety of men and women engaged in <a href="https://global.oup.com/academic/product/family-making-9780199656066?cc=gb&lang=en&">family-making</a> projects using assisted human reproduction. It also prioritizes the health and safety of children born of reproductive technologies. Meanwhile, the interests of those who contribute substantially to family-making — egg donors, sperm donors and surrogates — are repeatedly overlooked.</p>
<p>As researchers and advocates for women’s health, we are concerned about the ongoing failure on the part of Health Canada and others to see egg donors, sperm donors and surrogates as both critical participants and patients in the use of reproductive technologies. We urge policy makers to give due consideration to their health, well-being and interests in the making of public policy on assisted human reproduction.</p>
<h2>A narrow focus</h2>
<p><a href="http://laws-lois.justice.gc.ca/eng/acts/a-13.4/FullText.html">The Assisted Human Reproduction (AHR) Act </a> — the legislation governing the use of human reproductive technologies in Canada — was passed in 2004. As originally drafted, the act includes a number of provisions that require regulations in order for them to come into force. Most of these have never been introduced, including rules about how those donating eggs, sperm and embryos and those who act as surrogates should be paid.</p>
<p>Now, some 13 years later, Health Canada is finally taking the necessary steps to start drafting the missing regulations. An early step in this process has involved limited public consultation on a discussion document titled <em>Toward a Strengthened Assisted Human Reproduction Act: A Consultation with Canadians on Key Policy Proposals</em>. This document provides information about the direction of regulations-to-come in support of the AHR Act and asks the public for input.</p>
<p>An important problem with the discussion document (and the direction of the regulations it outlines) is the narrow focus on those who use assisted reproduction to build a family and those who are born of these technologies. </p>
<p>What about those who assist others with their family-making project? Assisted human reproduction often involves others — including egg donors, sperm donors and surrogates. In the discussion document, their interests are too often overlooked.</p>
<h2>Risks of egg donation</h2>
<p>In the section on “product safety,” for example, the discussion document provides considerable detail about the ways in which eggs and sperm (gametes) should be acquired so as to protect the health and safety of those using assisted reproduction, and of the children born. </p>
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<img alt="" src="https://images.theconversation.com/files/187458/original/file-20170925-22354-19psdkx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&fit=clip" srcset="https://images.theconversation.com/files/187458/original/file-20170925-22354-19psdkx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=600&h=400&fit=crop&dpr=1 600w, https://images.theconversation.com/files/187458/original/file-20170925-22354-19psdkx.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=600&h=400&fit=crop&dpr=2 1200w, https://images.theconversation.com/files/187458/original/file-20170925-22354-19psdkx.jpg?ixlib=rb-1.1.0&q=15&auto=format&w=600&h=400&fit=crop&dpr=3 1800w, https://images.theconversation.com/files/187458/original/file-20170925-22354-19psdkx.jpg?ixlib=rb-1.1.0&q=45&auto=format&w=754&h=503&fit=crop&dpr=1 754w, https://images.theconversation.com/files/187458/original/file-20170925-22354-19psdkx.jpg?ixlib=rb-1.1.0&q=30&auto=format&w=754&h=503&fit=crop&dpr=2 1508w, https://images.theconversation.com/files/187458/original/file-20170925-22354-19psdkx.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">Gamete donors and surogates are repeatedly viewed as mere ‘third parties’ in laws governing assisted reproduction in Canada and globally.</span>
<span class="attribution"><span class="source">(Unsplash/Sean Roy)</span>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
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<p>But what about the health and safety of the gamete providers and the surrogates? The risks associated with egg production, for example, <a href="https://www.ncbi.nlm.nih.gov/pubmed/18681998">are substantial</a>. And there are <a href="https://www.ncbi.nlm.nih.gov/pubmed/19022427">numerous reports</a> that <a href="http://jme.bmj.com/content/early/2016/03/07/medethics-2015-102964">informed consent is lacking</a>, as is <a href="http://www.cbc.ca/player/play/2198380237">adequate follow-up care</a> to address potential health risks such as ovarian hyperstimulation syndrome. </p>
<p>Nowhere does the government discussion document address the health and safety of the women from whom the so-called “products” are obtained.</p>
<h2>‘Third parties’ or vital contributors?</h2>
<p>In another section of the discussion document on the “risk of transmission of disease,” the focus is again narrowly on the would-be-parents and the children conceived. Accordingly, when reproductive material is tested and screened, the would-be parents are to be informed of the tests results so that they can take this information into consideration in making their reproductive choices. </p>
<p>There is no mention, however, of disclosing information about genetic or infectious disease to gamete donors and surrogates. Yet, surely they have an even greater claim on such information that they require to make both health-care and reproductive choices.</p>
<p>This lack of attention to the interests of gamete donors and surrogates has been a problem with the regulation of assisted reproduction in Canada from the beginning. These participants in assisted human reproduction are rarely included in policy consultations and their experiences are rarely studied. </p>
<p>They are typically referred to as “third-parties” in the reproductive process when they are, in fact, primary actors. In these ways they are thought of, and often treated, as nearly extraneous to the family-making projects they enable.</p>
<h2>Women as ‘spare parts’ and ‘walking wombs’</h2>
<p>Scholars in the field of assisted human reproduction (including us), have documented the many ways in which egg donors have come to be thought of as “<a href="http://www.utpjournals.press/doi/abs/10.3138/cjwl.25.2.249">spare parts</a>” rather than patients, and surrogates have long been dismissively thought of as “<a href="http://ca.wiley.com/WileyCDA/WileyTitle/productCd-0745602096.html">walking wombs</a>.”</p>
<p>This Health Canada consultation fails to see gamete donors and surrogates as participants in assisted reproduction, fully deserving of the same high-quality care as those who use the technologies to build their families. This is indicative of a broad and ongoing failure to take seriously the rights and interests of gamete donors and surrogates. </p>
<p>As Health Canada moves forward with this regulatory process, it is critical that all who participate in assisted human reproduction come to be understood as key actors in the use of reproductive technologies.</p><img src="https://counter.theconversation.com/content/84664/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Alana Cattapan has received funding from the Social Sciences and Humanities Research Council of Canada and the Canadian Institutes of Health Research. She is on the Board of the Canadian Research Institute for the Advancement of Women.</span></em></p><p class="fine-print"><em><span>Françoise Baylis has received funding from the Canadian Institutes of Health Research and the Stem Cell Network. She wrote the expert ethics report for the Canadian government in the Reference regarding the Assisted Human Reproduction Act S.C. 2004, c.2. She was a member of the inaugural Board of Directors of Assisted Human Reproduction Canada (2006-2010).</span></em></p>Health Canada is drafting important regulations for assisted reproductive technologies. Initial documents treat egg donors and surrogates as little more than spare parts and walking wombs.Alana Cattapan, Assistant Professor, Johnson Shoyama Graduate School of Public Policy, University of SaskatchewanFrançoise Baylis, Professor and Canada Research Chair in Bioethics and Philosophy, Dalhousie UniversityLicensed as Creative Commons – attribution, no derivatives.