Health Canada Threatens To Sue Doctor If He Reveals Whether Clinical Trials Data Shows A Drug Is Safe Or Effective

from the nothing-to-hide dept

As Techdirt readers know, one of the final sticking points of the TPP negotiations was the issue of data exclusivity for the class of drugs known as biologics. We've pointed out that the very idea of giving any monopoly on what amounts to facts is fundamentally anti-science, but that's a rather abstract way of looking at it. A recent case in Canada makes plain what data exclusivity means in practice. As reported by CBC News, it concerns unpublished clinical trial data about a popular morning sickness drug:

Dr. Navindra Persaud has been fighting for four years to get access to thousands of pages of drug industry documents being held by Health Canada.

He finally received the material a few weeks ago, but now he's being prevented from revealing what he has discovered.

That's because Health Canada required him to sign a confidentiality agreement, and has threatened him with legal action if he breaks it.

The clinical trials data is so secret that he's been told that he must destroy the documents once he's read them, and notify Health Canada in writing that he has done so. And just to concentrate his mind a little, there's this:

The confidentiality agreement also contains an indemnity clause that states Dr. Persaud, at his own cost, shall "save harmless Health Canada from and against all claims," including lawsuits, that arise out of any breach in the agreement.

Against this absurd background, it's easy to forget what we are talkling about here: basic scientific information relating to a drug that is widely taken by pregnant women -- a group where unexpected side-effects can have devastating consequences on the developing foetus. You would think Health Canada would be offering Dr Persaud every possible support for his work:

"I'm trying to find out if the medication is safe and effective and Health Canada is the regulator. So they might actually want to facilitate this sort of research that I am doing. Instead, Health Canada has threatened me with legal action if I share the information."

Persaud says that he is more concerned about the drug's efficacy than its safety, but that's clearly still an important issue, not least because having seen the clinical trials data, he has changed his opinion:

"I've gone on the record questioning how effective the medication was before," he said. "I think it's fair for me to say today that I'm concerned the medication is not effective at all."

Isn't that something fundamental that pregnant women have a right to know before taking the drug in question? And yet the pharmaceutical industry has somehow achieved the astonishing trick of normalizing the practice of withholding vital safety information, and turning national health agencies into enforcers of their data monopolies. As Duff Conacher, coordinator of Democracy Watch, a watchdog on open government, is quoted in the CBC News report as saying:

"Health Canada is setting up a system to silence critics of drug companies and protect big company profits and protect them from accountability, instead of doing what they're supposed to be doing, which is protecting the public from harm," he said.

And, if ratified, TPP will entrench that system even further.

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Filed Under: big pharma, biologics, clinical trials, data, drug data, exclusivity, health canada, navindra persaud, research, tpp