The fine folks at AllTrials have an important reminder for Canadians who are concerned about clinical trial transparency, and it’s time-sensitive!
We have just heard that we have a chance to improve clinical trial transparency in Canada. Bill C-17 or “Vanessa’s Law” is being considered this Tuesday and there’s a chance to get clinical trial transparency measures added to it.
We urgently need you to write to the MPs on the Standing Committee on Health to tell them how important clinical trial transparency is. A template letter is below, followed by the emails for the MPs on the committee. We’ll keep you posted about the Bill’s progress, but please send your emails today.
They have a sample letter on their website that you can email to the interested parties. Because many of us are also concerned about Vanessa’s Law ignoring potentially-dangerous natural health products, I sent a slightly modified version of the letter, which I’ve included below:
Ben Lobb, Chair firstname.lastname@example.org
Libby Davies, Vice-Chair email@example.com
Hedy Fry, Vice-Chair firstname.lastname@example.org
Eve Adams email@example.com
Claude Gravelle <firstname.lastname@example.org
Wladyslaw Lizon email@example.com
James Lunney firstname.lastname@example.org
Dany Morin email@example.com
David Wilks firstname.lastname@example.org
Terence Young email@example.com
Dear members of the House of Commons Standing Committee on Health:
I'm writing to you regarding Bill C-17, known as "Vanessa's Law". I am pleased that Parliament is considering a number of new measures such as the power to recall drugs that will significantly improve patient safety; however, I strongly believe the Bill needs key amendments to fully protect patient safety.
Specifically, it is clear that the bill needs to be amended (1) to require that all clinical trials and observational studies are publicly registered before they begin; (2) to mandate that all trials have their full methods and results reported after completion (preferably within one year); and (3) to include provisions for natural health products (NHPs) to be recalled in the same fashion as pharmaceuticals.
Results from around half of clinical trials have never been published and many have never been registered. New laws in the United States and Europe require the registration and reporting of future clinical trials but in Canada there is no legal requirement to register or disclose the results. Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated (at great cost). Further, the regulator's interpretation of the evidence must be publicly available when it approves, refuses or recalls a drug from the market.
Further, it's very important to ensure that information about clinical trials and observational studies is not considered confidential. This information is generated because people participate in trials in the hope of advancing knowledge. If we treat this information as private property, it ignores the contribution that clinical trial participants make.
Finally, it is my understanding that the law currently exempts natural health products (NHPs) from the same level of scrutiny that it applies to pharmaceuticals. To be clear, NHPs are drugs. They are pharmacologically active, they can be dangerous in certain circumstances, and they can have negative drug-drug interactions with pharmaceuticals. For this reason, it is vital that we not exclude NHPs from close scrutiny and potential recall simply because they are "natural".
I understand that Bill C-17, in its current form, lacks these important measures. For this reason, I'm writing to you, in your capacity as a member of the Standing Committee, to urge you to consider amending Bill C-17 to make sure Canada's drug regulatory system is transparent and to ensure that Canadians are protected from all drugs, whether they're "natural" or not. These critical amendments would ensure that the evidence base behind all drugs are open to scrutiny, physicians and other health care providers are adequately informed about the risks and benefits, and patients are better protected from harm.
If you’d like to ensure that medical decisions are based on all relevant evidence (or you’re concerned about the natural health products exemption), I recommend that you take a moment to send a similar email before Tuesday.
Hat tip to Ian Bushfield from Sense About Science.