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 As reported by CBC News, it concerns unpublished clinical trial data about a popular morning sickness drug: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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Comments on “Health Canada Threatens To Sue Doctor If He Reveals Whether Clinical Trials Data Shows A Drug Is Safe Or Effective”

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That One Guy (profile) says:

A telling response

The funny thing is, the doctor doesn’t actually have to say a thing at this point. The mere act of threatening him to keep him from revealing what’s in the studies makes it crystal clear that the drug companies know the drug is unsafe, ineffective, or both, and those they’ve bought in the government are covering for them.

Calling a press conference to announce just how bad the drug is would provide less confirmation of that fact at this point.

Anonymous Coward says:

Re: A telling response


It reminds me years ago of the conspiracy theories that elections were being rigged in the US by Diebald. It was started in part by the owners of Diebald being strongly pro-Bush supporters during the 2004 election.

Diebald helped spread the conspiracy by threatening to sue the pants off of anyone who dared said they were going to look at the code behind Diebald’s voting machines to verify the voting machines were 100% accurate and secure from hackers.

Derek Kerton (profile) says:

Re: A telling response

Nope. Cuz people are sheeple, and won’t get the information from the shackled doctor. Even the Techdirt article here is too “insider baseball” for the average Joe to read or understand.

And, BTW, a character assassination of Dr. Persaud is basically a certainty. The results of which will mean that other prescribing MDs will question his (unclear, unreleased) findings, but take the drug company reps side of the story as they play golf (/tennis/steak dinner/etc) together.

Without legal grounds to reveal the real data on the efficacy of the drug, agencies, insurers, and individuals will all carry on as if the drug were effective.

An analogy, you ask?
Sure. Prayer is statistically proven useless with respect to improving health outcomes. Christians in the US live pretty much the same lifespans as Atheists, and with essentially the same level of wellness. So, how important has that information been in reducing the use of prayer for health?

Wendy Cockcroft says:

Re: Re: A telling response

I was one of those sheeple till January 2012 when much of the internet went dark. Attempting to find out what it was about brought me here to TD.

So basically, when TD has the answers to your particular questions, you will find that the sheeple very quickly wake up, smell the coffee, and keep themselves informed. Of course it’s not just TD but you get the idea.

We can help by sharing links to these stories in our social media accounts, etc., to encourage our families and friends to get informed. It’s what I do. As a result non-tech-savvy friends interested in the Stop TTIP movement are now into TD because that’s where much of the information they want is.

Anonymous Coward says:

I’m not really surprised by this have any of you seen the big pharma commercials , with the warnings of death, suicidal tendencies , possible outbreak of facial lesions and many many more , I’m amazed that people still are still taking many of these drugs , to be honest the commercials scare the shit out of me.

Roger Strong (profile) says:

Re: Re: Re:2 and this is why

Back in 2008 when the Republicans were nationalizing all the Wall Street investment banks, bailing out a great many other banks, and bailing out the auto makers, it was explained this way:

The Conservatives in Canada are roughly equivalent to the more liberal Democrats in the US.

The Liberal Party is further to the left.

MUCH further to the left we have the have the unabashedly socialist NDP. They want to do things like spending huge amounts of public money to manipulate the national economy, and nationalize or take a large financial stake in banks and some large corporations. This makes them roughly equivalent to the Republican Party.

Seriously, things have reversed. Even Canada’s Liberals are arguably more conservative than America’s Republicans. It was Liberals who balanced the budget, while the Republicans only grandstand over how fast the yearly deficits should increase. It was the Liberals who stayed out of Iraq while the Republicans – who normally claim to be against foreign entanglements – marched in.

And that’s pre-2008. The party of Trump, Carson, Huckabee and the rest of the clown car is anything but conservative.

Anonymous Coward says:

Re: Re: Re:3 and this is why

The Conservatives in Canada are roughly equivalent to the more liberal Democrats in the US.


If Stephen Harper was American and had been the president, he would have nuked Russia, and by extension everyone else already. He’s the largest voice (that’s full of hate) regarding the neo-nazi fiasco in Ukraine. Only because there’s lots of ukrainians in canada, like 1.3 million, of course,but that kind of oppurtunism + his rhetoric, he’s pretty goddamn insane.

techie42 (profile) says:

Re: Re: and this is why

Have you met the current Corporate Overlord?
Right wing religion. Check
Passes environmental legislation written by Oil Companies. Check
Passes laws that anyone disrupting the economy (i.e. protest or boycotts) is a terrorist. Check
Burns books. (Fisheries and wild life library) Check.
Persecutes whistle blowers. Check
Gerrymandering. Check
Makes it harder to vote. (to combat those TWO voting incidents.) Check.
Caught cheating in the last election. (Robocall scandal. Check)
Mike Duffy payoff scandal (Our control freak PM insists he did not now what was going on in his own office.) Check
Discriminated against Muslim refuges from Syria (One dead kid on the beach. Many more in the water. But Orthodox Christians from Syria made it to Canada just fine.) Check.
An economy on the ropes because the PM ignored 9 of 12 sectors. (oil and beef good. Everybody else meh.)Check.
Takes credit for the banking sector getting through the US crisis; even though he was about to bring in US style banking rules just weeks before the US crisis hit. Check.

Anonymous Coward says:

Re: Re: Re: and this is why

Also what about all the back door deals for TPP and secretive meetings? That was Obama and the USTR under Obama. Even Chris Dodd almost threatened to stop funding the democratic party if he didn’t get his way. Not to mention Homeland security, under Obama, threatening to shut down movie sites at Disney (something that has nothing to do with homeland security). This problem is not a liberal vs conservative issue.

keithzg (profile) says:

Re: and this is why

and this is why , we need to vote out the conservative scum n offce today


Unfortunately the Liberals have said in terms of the TPP that they’ll “look at it”, basically, and although they’ve condemned the secrecy behind the deal they’ve been quick to repeatedly stress that they’re “pro-trade”. The NDP has said they flat out won’t accept it and won’t ratify. Frankly the likely conclusion is that it gets ratified in parliament by Conservatives and a large number of Liberals (or all, depending on how well they can whip their backbenchers, which will depend on how it goes). The only hope for Canada not ratifying the TPP is if the NDP forms the government, which unfortunately in an election where Jack Layton is gone and Trudeau is a household name again is unlikely. Still, point is, if you’re against the TPP, the NDP is a stronger vote in that direction.

Anonymous Coward says:

Re: Re: Re:

The news would probably ignore it. At least the mainstream news. They ignore important issues like these that make entrenched corporations look bad (unless it’s certain tech corporations like Google). Instead they would focus on the latest drug bust and how that’s associated with terrorism as being the cause of all our social ills.

Joe says:

Re: Re: Re: Re:

This isn’t 1985. The news doesn’t HAVE to run it. People communicate in mass numbers without going through a centralized-opinion mass media middleman. Information is viral. Tell everyone you know not to trust this pill because they refused to release the facts about it. I’m just waiting for some woman to go through discovery process, and make this an even bigger pile of mess.

jilocasin (profile) says:

One more step in the transformation of the government...

This is just one more step in the transformation of the government from serving the people to serving the corporations.

Treaties written by corporate interests, bypassing the nominally republic processes.

Investor-State Dispute Settlement (written by corporation naturally) set up a separate,but not equal, legal system heavily tilted toward corporations and against traditional governments.

United States DOJ helps Hollywood enforce civil copyright law, with an announcement from Disney’s headquarters.

So the fact the the Canadian Health agency is more concerned with Pharma profits [after recently being sued by Pharma for denying them an evergreened patent] than the health of their citizens, is sadly not surprising.

Just one more step toward our new corporate overloads…

Roger Strong (profile) says:

Re: One more step in the transformation of the government...

Like the US, Canada is trying to not only avoid a cold war with China, but to open up trade with them. This requires a lot of compromise, including on one’s principles.

Communism was once China’s highest ideal, where in Canada and the US it was democracy, capitalism and citizens’ rights. They’ve apparently agreed to meet half-way at authoritarian capitalism.

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