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

Mon, Oct 19th 2015 6:03am — Glyn Moody

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 As reported by CBC News, it concerns unpublished clinical trial data about a popular morning sickness drug: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

44 Comments

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That One Guy (profile), 19 Oct 2015 @ 5:51am

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.
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Anonymous Coward, 19 Oct 2015 @ 6:17am

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.
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Just Another Anonymous Troll, 19 Oct 2015 @ 6:30am

If information about something that affects you is deliberately withheld, it's usually going to be bad.
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Guardian, 19 Oct 2015 @ 6:41am

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

DONT CARE NDP, OR LIBERAL GO VOTE!!!!
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David, 19 Oct 2015 @ 6:46am

How do we call this?
Threatening bodily harm to millions of pregnant women? Sounds like terrorism to me. I mean, we have experience in bombing hospitals, so flying a drone attack on some medical administration pencil pushers in retaliation should be comparatively justifiable in comparison.

Sounds good, or am I forgetting anything?
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Anonymous Coward, 19 Oct 2015 @ 6:52am

If they are unwilling to publish the data it leads me to believe that there is something there. Now it just may indicate that this drug isn't as good as an older drug but it pays to assume the worst. Just as effective as the
placebo would not surprise me.
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TREASON, 19 Oct 2015 @ 6:55am

@5
@5 i call t treason ....
@6 and again that is harm and knowing it ...again lets start with treason....as its subverting the publics trust in the govt by a willful attack
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Anonymous Coward, 19 Oct 2015 @ 7:07am

Thalidomide anyone?
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Anonymous Coward, 19 Oct 2015 @ 7:08am

If he just dumps his analysis along with the data to back it up, he could probably take it to the supreme court arguing that he was saving lives and create a public safety exception.
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Agonistes (profile), 19 Oct 2015 @ 7:10am

Hippocrates would like a word with the physicians employed by Health Canada from beyond the grave, its that important.
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Anonymous Coward, 19 Oct 2015 @ 7:16am

Crown Copyright
This is what happens when a government agency holds its own copyrights. While it's hardly the only method that could be used for this, copyright is just too strong a tool to give regulators to cover up their decision process.
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That One Guy (profile), 19 Oct 2015 @ 7:26am

Re:
If nothing else it would likely create quite the PR black-eye if they actually tried to take him to court.

'Doctor sued for exposing health risks of drug used by pregnant women', the news would eat that right up.
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Mason Wheeler (profile), 19 Oct 2015 @ 7:27am

How is it even legal to put a drug on the market without publishing this information in the first place?

Maybe Shakespeare got it right: The first thing we do, let's kill all the lawyers.
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jilocasin (profile), 19 Oct 2015 @ 7:41am

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...
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SolkeshNaranek (profile), 19 Oct 2015 @ 7:59am

Re:
"the commercials scare the shit out of me"

The commercials do warn of anal leakage... so I guess they've CYA'd themselves for that as well.
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sorrykb (profile), 19 Oct 2015 @ 8:25am

Documents could still get out
Dr. Persaud might -- entirely accidentally -- leave the documents on his desk when he goes for a coffee. Not his fault that he couldn't trust some unknown public-health-minded person who happened to stop by to tidy up.
oops.

P.S. Good luck with the vote today, Canada.
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Roger Strong (profile), 19 Oct 2015 @ 8:32am

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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Anonymous Coward, 19 Oct 2015 @ 8:35am

Re: and this is why
Canada is more liberal than the U.S. so what makes you think this is a 'conservative' vs 'democratic' thing.
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Anonymous Coward, 19 Oct 2015 @ 8:37am

Re:
Lets see ... what's more important to government.

Corporate profits

Lives

I'm going to vote for corporate profits. The history of government has shown this over and over again.
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Anonymous Coward, 19 Oct 2015 @ 8:38am

Re: Re:
HAHAHAHA
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Anonymous Coward, 19 Oct 2015 @ 8:39am

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.
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Anonymous Coward, 19 Oct 2015 @ 8:40am

Re:
Nods in approval.
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Anonymous Coward, 19 Oct 2015 @ 8:54am

Re: A telling response
Yep.

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.
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sorrykb (profile), 19 Oct 2015 @ 9:13am

Re: Re: and this is why
Canada is more liberal than the U.S. so what makes you think this is a 'conservative' vs 'democratic' thing.

Maybe the fact that Stephen Harper of the Conservative Party of Canada has been Prime Minister for the past 10 years?
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Roger Strong (profile), 19 Oct 2015 @ 9:16am

Re: Re: and this is why
The Conservative Party of Canada has a well-earned reputation for being in bed with large corporations, far more than the other parties.
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Derek Kerton (profile), 19 Oct 2015 @ 10:08am

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?
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Derek Kerton (profile), 19 Oct 2015 @ 10:11am

Re:
"If he just dumps his analysis along with the data".

Yeah. Just prove that what you did was in the public interest. Easy.

Worked for Assange and Snowden, after all. Let's contact them in their New York penthouses to see what they think.
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Anonymous Coward, 19 Oct 2015 @ 10:40am

Re: Re: Re: and this is why
Their 'conservative' party is less conservative than our liberal party.
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Anonymous Coward, 19 Oct 2015 @ 11:39am

Re: Re: A telling response
Bev Harris.
https://en.wikipedia.org/wiki/Hacking_Democracy

this documentary appears to prove there was widespread fraud in u.s. elections. these fuckers left code on the machines that changed data.
the guy who coded this stuff died in a single engine plane crash not long after the election.
Coincidence?
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sorrykb (profile), 19 Oct 2015 @ 11:51am

Re: Re: Re: Re: and this is why
Their 'conservative' party is less conservative than our liberal party.
Harper's tried very hard to change that, and in that respect has seen considerable "success".
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Roger Strong (profile), 19 Oct 2015 @ 12:01pm

Re: Re: Re: Re: 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.
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techie42 (profile), 19 Oct 2015 @ 12:12pm

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.
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Anonymous Coward, 19 Oct 2015 @ 12:47pm

Re:
Health Canada are idiots, I'm Canadian and I can ascertain this. Now all that's left to do is someone in the field with the same opinion as Persaud to start spreading his opinion and just use another medication he has no issue with, along with the rest of the colleagues who agree with Persaud.
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Anonymous Coward, 19 Oct 2015 @ 12:49pm

Re: Re: Re: Re: Re: and this is why
>The Conservatives in Canada are roughly equivalent to the more liberal Democrats in the US.

lolno

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.
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keithzg (profile), 19 Oct 2015 @ 2:39pm

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

DONT CARE NDP, OR LIBERAL GO VOTE!!!!

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.
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Anonymous Coward, 19 Oct 2015 @ 2:39pm

Re: Re: Re: and this is why
"Persecutes whistle blowers. Check"

and Obama didn't go after whistle blowers?
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Anonymous Coward, 19 Oct 2015 @ 2:43pm

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.
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Joe, 20 Oct 2015 @ 1:26am

Re:
Tobacco, anyone?
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Joe, 20 Oct 2015 @ 1:32am

Re: Re: A telling response
There was kind of the reverse with the "let's all get infected" autism vaccine doctor. Doctor who? See what I did there? ;)
He attacked the entire concept of vaccines because of issues that are rare and no longer relevant. Takes special talent to assassinate the character of an entire profession.
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Joe, 20 Oct 2015 @ 1:39am

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.
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Wendy Cockcroft, 20 Oct 2015 @ 7:29am

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.
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Wendy Cockcroft, 20 Oct 2015 @ 7:31am

Re: Re: Re: Re: Re: and this is why
They're neoreactionary.
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Wendy Cockcroft, 20 Oct 2015 @ 7:31am

Re: Re: Re: Re: Re: and this is why
They're neoreactionary.
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nasch (profile), 20 Oct 2015 @ 11:06am

Re: Documents could still get out
Not his fault that he couldn't trust some unknown public-health-minded person who happened to stop by to tidy up.

A court might not see it that way.
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