‘Hiding patient-level clinical-trial data is comparable to hiding from investigators the mechanical records of a commercial jet that crashed. No sane person would help airlines keep them secret.’
Fifteen-year-old Vanessa Young of Oakville, Ont., died of a heart attack on March 19, 2000, after taking the prescription drug Prepulsid. Her father, Terence Young, established Drug Safety Canada in 2001 and has advocated for regulatory reform since. He was elected to Parliament in 2008 and galvanized both houses to pass Vanessa’s Law in 2014. It still has no regulations to empower key sections of the bill, four years after it received Royal Assent.
Dear Prime Minister,
I write you as both Prime Minister and as a father of three young children to request your immediate intervention to enforce Vanessa’s Law in Canada.
In 2001, GlaxoSmithKline’s Study 329 reported that its antidepressant blockbuster Paxil was safe and effective in adolescents with depression. But Study 329 was later debunked using clinical trial data — too late for many teens, including 18-year-old Sara Carlin of Oakville, Ont., who hanged herself after abruptly stopping Paxil, never knowing that 10.5 per cent of adolescent patients on Paxil had dropped out of a clinical drug trial because of serious psychiatric events, including suicidal ideation.
Prescription drugs used as prescribed are the fourth-leading cause of death in Canada, and the most common reason Canadians end up in hospital emergency rooms. Tens of thousands of patients suffer serious harms yearly.
Informing patients that all prescription drugs cause adverse effects, and how to use them safely, is critical to preventing injuries and deaths.
That is the reason both houses of Parliament passed the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) without dissent — which received Royal Assent four years ago, on Nov. 6, 2014 — and the reason every Canadian has a personal stake in the law.
It is also why the bill contains new transparency provisions for clinical-trial data, whereby the minister of health may order the release of that data to expose health risks. As the British Medical Journal reports, “a crisis of hidden or misreported information from clinical trials … is one of the leading scientific problems of our time.”
Yet the transparency provisions in Vanessa’s Law have been gutted with caveats and roadblocks in a Guidance Document that prioritizes protecting the data Big Pharma consider confidential business information (CBI), but Vanessa’s Law was written to expose. This helps drug companies hide the patient-level trial data critical to exposing risks, such as the number of people who died or dropped out of clinical trials, many of whom were experiencing dangerous adverse reactions that subsequently remained hidden.
These are deadly secrets. For example, the painkiller Vioxx was responsible for 60,000 deaths worldwide, in part because clinical trial data were ignored.
How many teens would have taken Paxil and died, had they known more than 10 per cent of people in clinical trials had become suicidal?
Hiding patient-level clinical-trial data is comparable to hiding from investigators the mechanical records of a commercial jet that crashed. No sane person would help airlines keep them secret.
Yet the hoops Health Canada demands independent researchers jump through do exactly that, such as requiring that they apply to an anonymous individual at Health Canada for data, who provides no reasons for a denial, and of whose decisions there are no appeals. To date, 10 of 12 applications from researchers have been rejected in this opaque process.
Incredibly, Health Canada also demands researchers sign a confidentiality agreement promising never to reveal to anyone the data they request, ensuring the most credible medical journals will not publish their results.
Assistant professor Peter Doshi from the University of Maryland had two applications rejected because he refused to sign the confidentiality agreement and sought a judicial review, arguing in the Canadian Federal Court that the denial had no basis in law and would impede his ability to conduct his research and get it published.
On July 9, Justice Sébastien Grammond of the Federal Court agreed, slapping down Health Canada. He ordered the data released for several reasons, including contradicting the purpose of Vanessa’s Law — to improve clinical-trial transparency — and for failing “to assess the effects of its decision on Mr. Doshi’s freedom of expression,” as guaranteed in the Canadian Charter of Rights and Freedoms.
Health Canada breached the Charter. Yet the offending policy is still posted on its website three months later.
Your government has not published even one regulation in four years to empower other sections of Vanessa’s Law, which lie dormant. Yet the proposed regulations are no better.
One actually proposes cancelling the current requirement for drug companies to report patient-level data to get drugs approved in the first place. Health Canada plans to accept summaries instead, saying reporting is such a “burden” on the drug companies. How about just emailing the documents?
Another would limit the health-care institutions that must report all serious adverse drug reactions to only the largest hospitals, letting hundreds of clinics and long-term care (LTC) facilities across Canada totally off the hook, despite the fact that over-prescribing to seniors in LTC facilities is a common cause of serious harms.
By the thinking at Health Canada, when vulnerable patients are killed or seriously harmed by prescription drugs in these institutions, it is too much of an administrative burden for administrators to take 20 minutes to fill out an online form answering nine questions to help prevent further such deaths.
Is this acceptable to you?
Does this sound like an agency or government concerned with the safety of patients, or one concerned with helping big Pharma protect its commercial prospects? Because the federal court just concluded there is no middle ground.
We have little reason to believe that Health Canada officials recognize the clear letter and spirit of Vanessa’s Law, or intend to enforce it as Parliament intended, or to recognize they regulate only in the public interest.
We fully support your commitment as Prime Minister to transparency and evidence-based decision-making in governance, and assure you there is no place where transparency is more important than in the development and approvals of prescription drugs. It is a matter of life and death.
We respectfully request your support for parliamentary hearings on the Guidance Document and proposed regulations for Vanessa’s Law now, before it is too late.
Without your intervention, Vanessa’s Law will end up a false promise and dead letter to Canadians. Canada can, and must, do better.
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