{"id":36816,"date":"2016-06-06T17:11:05","date_gmt":"2016-06-06T16:11:05","guid":{"rendered":"http:\/\/stg-blogs.bmj.com\/bmj\/?p=36816"},"modified":"2016-06-06T17:11:38","modified_gmt":"2016-06-06T16:11:38","slug":"pharmaceutical-transparency-in-canada-tired-of-talk","status":"publish","type":"post","link":"https:\/\/stg-blogs.bmj.com\/bmj\/2016\/06\/06\/pharmaceutical-transparency-in-canada-tired-of-talk\/","title":{"rendered":"Pharmaceutical transparency in Canada: Tired of talk"},"content":{"rendered":"

Health Canada has been talking about improving the transparency of information around pharmaceutical drugs for years<\/a>. And for years the drug regulator has failed to back up<\/a> that talk with commitment and action.<\/p>\n

The lack of transparency around pharmaceutical drugs continues to undermine patient safety and public health. Unless a drug\u2019s full safety and effectiveness profile is transparent, physicians and patients alike are at best misinformed. At worst, patients could suffer significant harm\u2014even death\u2014after taking a government approved, physician prescribed drug and taxpayers will be left to foot the bill.<\/p>\n

The problem stems from the fact that lots of evidence about a drug\u2019s safety and effectiveness is never published:\u00a0sometimes because journals don\u2019t accept it for publication, other times because the researchers and company sponsors choose not to disclose it, especially if the outcome of the study would be perceived to negatively affect sales. In other cases, it is published in a manner that does not accurately reflect what actually happened.<\/p>\n

Government regulators do evaluate both published and non-published evidence but only in confidence with drug manufacturers\u2014a model that has proven deeply flawed. Whether it was evidence of heart attack risks<\/a> with the pain relief drug rofecoxib (Vioxx)<\/a> of the late 1990s and early 2000s or studies of children and teenagers\u2019 use of the antidepressant paroxetine (Paxil)<\/a>, time and again, patients have been exposed to serious risks while regulators have been slow to act, were being misled by the companies involved, or simply missed gaps in the evidence\u2014all behind closed doors.<\/p>\n

Greater transparency is needed so that researchers can independently assess a drug\u2019s safety and effectiveness and doctors can examine the data to ensure the appropriateness of their prescribing, while investigative journalists and civil society at large put public pressure on regulators and industry to improve their practices.<\/p>\n

Several countries (for example, the United States), regulators (for example, the European Medicines Agency), and international institutions (for example, the World Health Organization) have made important transparency commitments followed by concrete action. Transparency remains a work in progress, but laws have been put into place and are beginning to be enforced.<\/p>\n

In contrast, until recently, Canada has done little more than talk. Following numerous parliamentary committees, auditor general reports, journalist investigations, and academic researchers calling for greater transparency, Health Canada has offered up several supposed transparency initiatives. But each has failed to deliver meaningful change<\/a>.<\/p>\n

In late 2014 Canada\u2019s parliament finally made a commitment to improving transparency around pharmaceutical interventions by enacting \u201cVanessa\u2019s Law.\u201d<\/a> Inspired by the death of former MP Terence Young\u2019s daughter, Vanessa, the law gives the minister of health and in turn Health Canada several new and important powers in the name of patient safety. This law has great promise to finally turn things around and open up the black box of medicines\u2019 safety in Canada.<\/p>\n

One provision in Vanessa\u2019s Law, section 21.1(3)(c), gives the minister of health the power to disclose information that companies and Health Canada have kept confidential to any person \u201cwho carries out functions relating to the protection or promotion of human health or the safety of the public\u201d provided that \u201c<\/em>the purpose of the disclosure is related to the protection or promotion of human health or the safety of the public.\u201d<\/em><\/p>\n

Section 21.1(3)(c) is discretionary: the minister may <\/em>disclose such information. It also treats\u2014in our view wrongly\u2014clinical data as \u201cconfidential business information\u201d (CBI), thereby confirming secrecy as the norm. However, the provision is otherwise worded very broadly. It has the potential<\/a> to open up reams of information that companies and the regulator have\u2014again, wrongly\u2014treated as private property for decades. Unless and until parliament explicitly excludes unpublished drug studies as CBI, section 21.1(3)(c) has a critical part to play in fostering greater transparency.<\/p>\n

Once again though, Health Canada is threatening to undo Vanessa\u2019s Law\u2019s commitment to transparency. In March<\/a> it published its draft guidance about how it intends to interpret section 21.1(3)(c), cementing an approach that has already stymied<\/a> access to safety and effectiveness drug information.<\/p>\n

Contrary to the provision\u2019s broad wording and the purpose of Vanessa\u2019s Law, Health Canada\u2019s draft guidance narrows who is eligible to ask for drug information, while requiring the few that the regulator deems eligible to make a request to sign a strictly worded confidentiality agreement and demonstrate efforts to obtain the information from \u201call other possible sources\u201d before receiving the information.<\/p>\n

In response to Health Canada\u2019s call for public commentary on its draft guidance, we wrote and coordinated a series of submissions\u2014from clinicians and researchers<\/a>, representatives of civil society<\/a>, and legal scholars<\/a>\u2014calling on Health Canada to remove these limitations and exclude drug safety and effectiveness from the category of CBI. The draft guidance is, in legal terms, deeply flawed and may violate the Charter of Rights and Freedoms<\/a>.<\/p>\n

Unless Health Canada listens to our submissions, Vanessa\u2019s Law will become just the latest example of transparency talk rather than concrete commitment and action. At that point continuing to talk transparency will itself become harmful, obscuring the absence of real change.<\/p>\n

Health Canada must return to the drawing board<\/a>. Canadians have a right to know how safe and effective\u2014or unsafe and ineffective\u2014their medicines are. Anything less will come at a great cost to patient safety and public health.<\/p>\n

Matthew Herder<\/em><\/strong>, associate professor, Health Law Institute, Faculties of Medicine and Law, Dalhousie University, Canada.\u00a0Twitter: @cmrherder<\/a><\/em><\/p>\n

Trudo Lemmens<\/strong>, professor and scholl chair in health law and policy, Faculties of Law and Public Health and Joint Centre for Bioethics, University of Toronto. Twitter: @TrudoLemmens<\/a><\/em><\/p>\n

Joel Lexchin<\/strong> is currently a professor in the School of Health Policy and Management at York University in Toronto, Canada, where he teaches health policy. In addition, he has worked in the emergency department at the University Health Network, also in Toronto, for 28 years. He is the author or co-author of over 150 peer-reviewed articles on a wide variety of topics concerned with Canadian and international pharmaceutical policy.<\/em><\/p>\n

Barbara Mintzes,\u00a0<\/strong>senior lecturer,\u00a0Charles Perkins Centre and Faculty of Pharmacy, The University of Sydney.<\/em><\/p>\n

Tom Jefferson<\/strong>, honorary research fellow, Centre for Evidence Based Medicine, Oxford.<\/em><\/p>\n

Competing interests:<\/strong><\/p>\n

Matthew Herder<\/strong> is the principal investigator on a grant awarded by the Canadian Institutes of Health Research (EOG 123678) entitled \u201cEmerging health researchers and the commercialization of academic science.\u201d MH is a member of the Health Policy Translation research group of the Canadian Center for Vaccinology (CCfV), which has carried out a number of clinical trials sponsored by vaccine manufacturers. MH has not been involved, in any way, with the conduct of these trials, nor received any funds from CCfV to carry out research. He has no other personal, organisational, or relational conflicts of interest to disclose.<\/p>\n

Trudo Lemmens<\/strong> presented in 2016 as a plenary speaker on the regulation of research ethics review at a symposium organised by La Asociaci\u00f3n de M\u00e9dicos Especialistas en la Industria Farmac\u00e9utica, A. C. (Ameifac), CANIFARMA (C\u00e1mara Nacional de la Industria Farmac\u00e9utica)<\/a>,\u00a0and the Universidad Autonoma de Mexico. His travel and hotel costs in Mexico were paid by the organisers; TL asked the speaker fee to be forwarded directly by the organisers to a Mexican indigenous social advocacy organisation.<\/p>\n

Joel Lexchin<\/strong> has no competing interests to declare.<\/p>\n

Barbara Mintzes<\/strong> has acted as an expert witness for the legal teams representing plaintiffs in two Canadian class action suits: on hormone replacement therapy and breast cancer risks, and on testosterone and cardiovascular risks. She has no additional competing interests to declare.<\/p>\n

Tom Jefferson<\/strong> was a co-recipient of a UK National Institute for Health Research grant (HTA \u2013 10\/80\/01 Update and amalgamation of two Cochrane Reviews: neuraminidase inhibitors for preventing and treating influenza in healthy adults and children\u2014http:\/\/www.nets.nihr.ac.uk\/projects\/hta\/108001<\/a>).<\/p>\n

TJ receives royalties from his books. TJ is occasionally interviewed by market research companies about phase I or II pharmaceutical products. In 2011-13, TJ acted as an expert witness in a litigation case related to oseltamivir and in a labour case on influenza vaccines in healthcare workers in Canada. He has acted as a consultant for Roche (1997-99), GSK (2001-2), Sanofi-Synthelabo (2003), and IMS Health (2013) and in 2014 was retained as a scientific adviser to a legal team acting on oseltamivir. In 2014-15 TJ was a member of two advisory boards for Boerhinger. He is a member of an independent data monitoring committee for a Sanofi Pasteur clinical trial.<\/p>\n","protected":false},"excerpt":{"rendered":"

Health Canada has been talking about improving the transparency of information around pharmaceutical drugs for years. And for years the drug regulator has failed to back up that talk with commitment and action. The lack of transparency around pharmaceutical drugs continues to undermine patient safety and public health. Unless a drug\u2019s full safety and effectiveness […]<\/p>\n

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