In a debate in the Canadian House of Commons, Conservative Member of Parliament Terence Yong called clinical trial transparency “critical” and stated that he would like to see the registration and reporting of clinical trials added to his bill to amend the Food and Drug Act.
The comments were made on 28th March 2014 during the second reading of Bill C-17, commonly known as Vanessa’s Law, which gives Health Canada new powers to ensure the safety of pharmaceutical drugs. From Hansard:
Ms. Megan Leslie (Halifax, NDP):
I want to talk about next steps. One step that I see coming after this legislation would be to include mandatory registration of clinical trials and public disclosure of those findings. I recognize that is not in the bill right now. I recognize that the bill is a great first step, but I want to keep going on this. He said it is the beginning of the end.
What are his thoughts on next steps? Would that be one of them?
Mr. Terence Young (Oakville, CPC):
Mr. Speaker, I want to thank the member opposite for her kind words and for her support on this issue, over a long time.
I agree with the member. The transparency in research and clinical trial research is a critical part of improving the data the drug companies use to get drugs approved in the first place.
They are very secretive about it. They refer to it as “commercial rights” or “trade secrets”, or whatever, but I do not believe it is.
When a pharmaceutical company hires someone to do a clinical trial, they normally ask the researcher to sign a contract, which is basically a gag order that says the company can stop the trial at any time and he or she must never talk about it again. If the trial is not going well for the drug, that is what they do. No one knows the trial was even started. If the trial shows the drug might be harming patients, they stop the trial and the researcher can never talk about it again, or never get work again as a researcher. They could do a number of trials like that on a drug until they finally find a researcher who gets them the positive result they want.
I agree with registering all trials, that it should be done, and that even if the trial is stopped early, all the data should be published.
I see the CMAJ has requested or suggested that this go into Vanessa’s law. I can only say that the Minister of Health is willing to consider amendments to Vanessa’s law and I would be very pleased if that were put into the bill.
We will continue to monitor progress on this bill and are encouraging more Canadians and Canadian organisations to join AllTrials. Share the petition with everyone you know and help us make sure all clinical trials are registered and reported.