by Roojin Habibi and Joel Lexchin
Why is Health Canada only letting doctors and the public know part of the story about the safety and effectiveness of new pharmaceutical drugs? Inadequate information can be as dangerous as misinformation. Here's how.
We published a new study this week in the journal PLoS One that examines how well Health Canada informs the public about the effectiveness and safety of new drugs and why they were approved. The results are not comforting.
Normally, when a drug company seeks to market a new drug in Canada, it submits information about safety and effectiveness from clinical trials solely to Health Canada. If Health Canada agrees to allow the drug on the market, all of that information is considered commercially confidential and unavailable for public scrutiny -- unless the company chooses to publish a specific study, thus making it public.
If the drug data is not published, Canadians would need to make a formal Access to Information request to access it, but this request may or may not be granted depending on the whim of the company owning the data.
The transparency of Health Canada's drug review process has been scrutinized in the past -- and found wanting -- most recently by the Auditor General of Canada who concluded that it "did not fulfill long-standing commitments to increase the transparency of authorized clinical trials."
Health Canada has piloted the "Summary Basis of Decision" project in response to these criticisms -- an on-going effort in place since 2004. The aim of this project is to, in the words of Health Canada, ensure that "Canadian healthcare professionals and patients will have more information at their disposal to support informed treatment choices."
Summary Basis of Decision documents are supposed to summarize the clinical trial information that was considered by Health Canada prior to approving a new drug -- and make it available to doctors and the public to enable evidence-informed decision-making. This should be a step in the right direction.
Unfortunately, this is not what our study found.
We analyzed documents from the first phase of the Summary Basis of Decision project. Overwhelmingly, we found these documents to be riddled with inconsistency and ambiguity, and missing key information about the safety and effectiveness of drugs.
Looking at these documents, doctors would not be able to tell if the patients taking part in the clinical trials were similar to the ones that they see in their offices. For example, the majority of the documents did not reveal the age of patients in the trials examined, nor the number of men and women. Over 97 per cent of documents did not give complete information about how many people withdrew from the trials and significant information about the results of the trials was missing from over two-thirds of the documents.
Knowledge about safety and effectiveness informs the list of drugs that make it onto provincial drug formularies. It helps bring to fruition highly useful syntheses of evidence answering some of medicine's most pressing questions regarding therapeutic options.
Take the Vioxx (rofecoxib) scandal, for example, where tens of thousands of people died from taking a Health Canada approved pain killer. It should serve as a vivid reminder that policies that thwart data transparency pose a very real threat to the health of patients.
Had all of the clinical trial data that was in Health Canada's possession about Vioxx been publicly available, independent drug researchers may have been able to identify the safety problems with the drug at a much earlier stage.
We urge Health Canada to take a proactive stance in setting the record (or in this case, the evidence) straight, and publish in full the reports of clinical trials that it receives from sponsoring companies.
This certainly would not make Health Canada a trailblazer on the international scene; the United States Food and Drug Administration already publishes the full reports from its reviewers, and the European Medicines Agency is moving towards full disclosure of all information in trials by the end of 2014.
We support the voices of patients, health professionals, researchers, policymakers and industry officials, who recognize that the proper and timely dissemination of clinical trial information is not a matter of whim or inclination, but a debt long overdue to the public.
Roojin Habibi is an MSc candidate in McMaster University's Global Health program, and a Research Fellow at the Pharmaceutical Policy Research Collaboration (PPRC).
Joel Lexchin is an advisor with EvidenceNetwork.ca and a professor in the School of Health Policy and Management at York University, an emergency physician at the University Health Network and an associate professor in the Department of Family and Community Medicine at the University of Toronto.
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