"Sense about Science: Follow the Lawsuit
June 16, 2014 9 Comments
Editorial Note: This is a third in a series of posts about Sense about Science and Access to Clinical Trial Data that began with Follow the Rhetoric and followed up with First Admit no Harm.
There are some facts in the last few posts. There are also some extrapolations that may not be right.
Tracey Brown has gone on the Parliamentary Record to make clear what AllTrials are asking for – its not the data and not even full Clinical Study Reports. If This is the AllTrials position, it is easy see why GSK felt they could sign up. Even ghostwriting companies have signed up. But perhaps AllTrials have moved on.
It may be that the GSK periscope is an invention of subversives within GSK who saw a way to persuade AW1 that this would block access to the data for ever – all the time intending to gradually make it more and more user friendly and accessible. Perhaps AW1 is the mastermind trying to leverage things forward.
I’ve been a consultant to pharma and an expert for both plaintiffs and pharmaceutical companies in lawsuits. These contacts definitely bias me – as much by virtue of the people you meet as the money you might be paid. Under oath when asked if I’m biased I have always said yes – absolutely.
But I’ve never thought when it comes to science that it matters whether I or anyone linked to RxISK are moral or even nice people. Science might be better served if I’ve got some strange biases or am being paid to try and find the flaws in an argument. The key thing is access to the data, and given access to the data the more biases the better. Sometimes it takes a true weirdo to see how the data hangs together.
Being motivated whether because you have suffered an adverse event or because you’re being paid makes a difference to the effort you put in to solving problems. But at the end of the day, if you aren’t free to access the data it’s not science. If you’re a doctor and accept not being given access to the data – such as all doctors and statins – that’s quackery not medicine.
Science moves ahead, when people with different biases have their views challenged by the data. This is the very definition of science as opposed to philosophy or the humanities or business.
Medicine moves ahead when things happen to patients and when doctors and patients work to understand what has happened.
Business would likely do better in the long run if it built on this framework of doctors and patients working together to generate new knowledge. But instead at the moment business is not open for business on this issue. Why?
Study 329 & The Lawsuit that Didn’t Bark
Linked to Peter Doshi’s RIAT initiative, a group of us are working on re-authoring Study 329 – close to the most famous RCT of all time. In this study GSK’s paroxetine (Paxil) was compared to imipramine and placebo in a group of children.
Those of us taking on this re-authoring job were among the first to be introduced to the GSMA-ESK scope – a periscope for looking at the data on which the GSK seagull regularly sits blocking the view.
The periscope gives the outside world the illusion GSK are offering transparency but it’s not meaningful transparency.
But periscopes are not the crux of the matter.
Children became suicidal on paroxetine in Study 329.
Before they had the results of Study 329, GSK had seen patients in clinical practice and clinical trials become suicidal and homicidal on paroxetine where the company had coded the event as caused by their drug. They knew the profile of what happens when an SSRI causes a problem. In their adult trials from the late 1980s, there was a doubling of the rate of suicidal acts on paroxetine compared to placebo.
They have run clinical trials that use the fact that paroxetine caused people to become suicidal to hide the fact that paroxetine caused people to become suicidal.
In breach of FDA regulations they had moved wash-out suicidal acts into the placebo column in clinical trials to hide the problem.
But in public, they have consistently denied there is a problem.
In Study 329, paroxetine didn’t work and wasn’t safe. Sally Laden ghostwrote the 329 paper and made paroxetine safe and effective. There were 22 authors on the authorship line, possibly none of which barring company personnel had seen the full dataset.
The consent form says that in this trial you will be treated in just the same way as you would in normal clinical practice. Even from the protocol it was clear this was a lie.
The children taking imipramine were to be force titrated to 300mg where possible – this is just not normal clinical practice. This is double the standard dose for adults. It’s dangerous and seems designed to make imipramine look worse than paroxetine.
Even so imipramine wasn’t worse than paroxetine. There was a statistically significant elevation in the number of children on paroxetine who had a suicidal event in this trial alone compared to placebo.
In normal clinical practice if someone becomes suicidal on an SSRI it would be usual to make the link for them and tell them that in future they should try an antidepressant from another group. They are much more likely than the average person to become suicidal if exposed to another SSRI.
If the drug has caused the problem, it’s very important to their self-image that they know this. They are being done a further injury, in this case an unnecessary one, if this information is withheld from them.
Have any of the children who became suicidal on paroxetine been told that paroxetine may have caused their problem?
Whose Baby is it?
GSK say it’s the doctors – the non-authors of the paper – who know these children, whose responsibility it is to say whatever needs to be said to any of these children.
These are doctors who refuse to retract a paper that has been deemed fraudulent by New York State Attorney General Elliott Spitzer’s office. (Elliott Spitzer of Good Wife fame).
To come full circle, this is the paper that led to the data access story we have today. In response to a fraud charge in 2004, GSK agreed to post the CSRs on the company website in downloadable (non-periscope form).
Without Study 329 and the subsequent fraud charge and later $3 billion fine, GSK would likely never have felt the need to sign on to AllTrials.
Tomorrow and Tomorrow and Tomorrow
This is not a piece of history. This is our future.
Right now today GSK are refusing to tell the children who have been injured by their drug in Study 329 that they were injured by their drug. Tomorrow GSK will do the same and tomorrow and tomorrow.
Their drugs never injure people.
The reason GSK, Pfizer, Lilly and AbbVie don’t want anyone to get access to the data is so that no-one can access the damage. No-one can find out about the Dan Markingsons who die or are injured in company trials.
They are not doing this out of a concern for Dan Markingson’s confidentiality. They are doing it in order to avoid being sued.
This, Ben and Iain, is why I think GSK are playing the confidentiality card.
What do you think? And what should we do about it?
The Cowardice of a Pampered Society
Tracey Brown and Dick Taverne of Sense about Science (SAS) have a publication:
Over-precautionary Tales: The precautionary principle represents the cowardice of a pampered society.
Is this Sense about Science?
What would the real SAS – the Short Arm Squad – say?
See SAS to Lisbeth"