Reading the Minneapolis StarTribune, it was the reference to privacy that clinched it.
Facing a sexual abuse lawsuit, the archdiocese of St Paul and Minneapolis made a big deal of putting an independent panel in place to investigate. They put the Reverend Reginald Whitt in charge of appointing the panel and receiving its reports on behalf of the archdiocese.
An Independent Panel that Sticks to the Rules
Rev. Whitt told priests and deacons that the task force may review specific files to determine whether the policies of the archdiocese concerning clergy sexual misconduct were properly followed. But, he wrote, “Access to these files will be within my control, and limited only to what is necessary for the task force.”
He also wrote that he recognized that many priests and deacons “may be anxious about your right to privacy and a good reputation.” He assured them that the archdiocese will proceed according to the principles of due process and uniform application of canon policy.
This sounds terribly like the approach Sir Andrew Witty is attempting to put in place for GSK, AbbVie and the rest of the branded pharmaceutical industry vis-a-vis abuses, including child abuse committed in their name.
Is Abuse too strong a word? In Study 329, a controlled trial of Paxil given to children, there was a statistically significant increase in suicidality on Paxil compared to placebo. These children were unquestionably injured but it seems about as likely that GSK has contacted the children involved to tell them what happened as the Catholic Church has voluntarily got in touch with anyone who has been affected by their priests or nuns to inquire about their wellbeing.
In Study 329, the consent form tells parents and children that the child will not be exposed to any danger or risks beyond what would be found in normal clinical practice – but the protocol for the study involved an attempt to force-titrate children up to a dose of 300 mg of imipramine. This is double the standard dose used for adults – at least in Europe. One reasonable hypothesis as to why this might have been done was that it was an effort to make Paxil look good. Pretty grim if it was.
Just as the Church is insisting on the Privacy Rights of its priests, GSK, AbbVie and others have taken a legal action against the European Medicines Agency in an effort to claim Corporate Privacy Rights (See Let’s Do the AbbVie Again, Avoiding Adverse Events).
Just as we respect an individual’s right to believe what they want – to be a Muslim, Hindu, Christian or Jew – and defend a pregnant woman’s right to control what happens to her body, GSK and AbbVie are claiming a comparable right to decide what the clinical trial data they hold mean.
They are asserting their right to spin their version of what it is you put in your body even though this clashes fundamentally with your right to know what you are putting in your body.
Companies operate their own version of Canon Law. Canon law is the Church’s own internal legal system that the Church insists has primacy over national judicial systems. The Bishops and Cardinals adhere to this rather than the laws of the US or other countries. Whether intended or not, this is a system that favors the clerical abusers over abused children. It is this that has fueled the anger of those who have been abused. There would be little problem if the Church’s legal system were harder on the Clerics than on Children. But using a system that defies natural justice to safeguard Clerics not unsurprisingly causes anger.
GSK and other companies run something similar. They actively attempt to over-ride the legal systems of the United States and other countries with claims that unless findings are demonstrated in controlled trials to a statistically significant extent that they simply aren’t happening.
The US Federal Judicial Manual states that convincing evidence of challenge, dechallenge and rechallenge is the way to demonstrate that a drug has caused an adverse event. No place here for statistical significance.
With a flourish worthy of the best Jesuits, internally GSK and other companies apply exactly the approach advocated by the Federal Judicial Manual when assessing whether Paxil has caused a birth defect or suicide, but even after deciding in private their drug is guilty, in public they insist there is no — absolutely no — evidence that their drug has caused a problem.
This can even leave GSK personnel stating in public that they are not aware of a single side effect that is caused by Paxil or likely any of their drugs. See Burn in Hell.
The US Supreme Court has weighed in on this question and decided that GSK’s model is wrong. People have a right to make up their own minds as to what an adverse event profile means. The only people who have this right at the moment though are investors. Patients and doctors have no rights – at least not established.
Church of GSKology
GSK have applied to be treated as engaged in Science. They say that what they do has all the features of Science – clinical trials, peer reviewed publications.
Ideally the Courts would decide that rather than being a Science they are a Church – they operate a system that requires belief without evidence. There is less doubt that their publications are ghost-written than that the Bible is.
While they have people with great public relations skills like James Shannon who say all the right things in public, like the Catholic Church GSK appears to operate an Opus Dei-like arm which enables them to place their people close to the heart of Britain’s regulator, the MHRA, and other bodies. They are close to being the Established Church in England.
In the face of abuse, GSK makes a big deal about apparent reform but the Rev Whitt described the mechanism GSK has put in place perfectly: “Access to these files will be within my control, and limited only to what is necessary for a Responsible research proposal.”
Waiting for a Frances?
When it comes to reform it seems Andrew is a Ben not a Frankie.
We need some Martin Sixsmith or Dan Brown to write a book and make a movie on the lines of The Lost Child of Philomena Lee.
Don’t hold your breath. GSK is a lot scarier than the Catholic Church.
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Lives Touched by GSK
Notes of a Paxil Guinea Pig
What does GSK owe to the youngsters in its infamous Study 329 who became suicidal while taking the company’s paroxetine (Paxil/Seroxat)?
As someone who was briefly a GSK Guinea Pig, I’d say the most important thing they’re owed is the truth. It’s a highly delinquent debt – but it’s not too late for GSK to pay up.
I took part in a study of Paxil back in 1994. Like many U.S. subjects, I signed up mainly for the free medical care: I was tired of battling my employer’s HMO which doled out mental health treatment with an eyedropper. However, having already taken Prozac with little or no effect, I was also as curious as anyone to find out if these drugs “worked” or not, according to Big Science. I was willing to be a guinea pig if it would lead to some answers.
The protocol was that everyone was put on Paxil for a number of weeks, after which half of us would be switched cold-turkey to placebos, the other half would continue on Paxil.
Supposedly, this would determine whether people with “recurrent depression” should stay on long-term Paxil maintenance therapy. Looking back, however, what the study really did was to produce drug-withdrawal distress, then interpret that as the original depression coming back. And most likely, by 1994, GSK knew that.
Treatment Related Injury?
After the switch to either placebo or Paxil I fell asleep at the wheel of my car and had an auto accident with minor injuries. I didn’t want to drop out – I was pretty sure the cause of my accident wasn’t Paxil, but working a sixteen-hour shift. But I was told the study protocol demanded my removal. Not knowing the research design, I never found out whether they were being conscientious, or just the opposite – dropping my results to cover up problems.
The Paxil hadn’t helped me much. But after the switch, I quickly felt the ground under my feet get rockier, at least for awhile.
Well, I thought, it didn’t feel like the Paxil was doing me any good – but here I was feeling worse without it. It didn’t occur to me that this could be down to Paxil withdrawal, because I had never heard of it.
Once the blind was broken, the researchers confirmed I had indeed been switched to placebo.
I never found out if my study was published. When I finally saw a psychiatrist, his reaction was that this had been a “pretty stupid study,” because “everyone already knew” that people like me who’d had several depressive spells should be on medication for life. That makes me think there were already multiple published studies of this type – and possibly dozens more that the drug companies never bothered to publish.
GSK & Responsibility
I’m angry with GSK, not only for putting me through Paxil withdrawal, which, thank god, was not severe in my case, but also for what they later did to me and other patients by hiding the results. They and the other drug manufacturers led millions of us to believe we needed these drugs for life, “just like diabetics need insulin.”
At a minimum this deprived millions of people of a normal sex life, and may have numbed their ability to respond to life in other ways. Untold numbers of children have been exposed in utero. And I and millions of others became part of a twenty-year uncontrolled experiment on the long-term use of these drugs to control a “deficiency” that we may never have had.
For the kids in Study 329 who became suicidal on Paxil, GSK’s deception may have done much worse. To this day, I’d bet some of them don’t know the role of the drug in their suicide attempt. Being “the kid who tried to hang himself at fourteen” affected how they saw themselves, to say nothing of how their families, schools and juvenile courts may have seen them. It’s long overdue – but not too late – to tell them that “what you did was not necessarily your own doing.”
Knowing the facts about the limited effectiveness of these drugs could also open doors for those who have not responded to them. For two decades we’ve been told we were a small minority whose condition, being Treatment Resistant, must be very grave indeed. That verdict led many to accept punishing multidrug treatments, ECT, or simply becoming resigned to a life of disability.
Like the kids in Study 329, we deserve the opportunity to rewrite the life story handed to us by well-meaning professionals acting under the influence of GSK.
It’s not too late to learn something useful from the changes GSK put us all through. It might help us learn more about SSRI withdrawal and SSRI-induced agitation, including who suffers what effects and why. I have no idea what consent forms I signed 20 years ago, but I sure as hell never intended to give GSK the right to hide the results of the experiment they ran on me.
GSK owes me the truth. It owes at least as much to many others, like the kids in Study 329, who suffered far more than I did. To say nothing of the patients who never took part in research, but whose lives were altered by it nonetheless. It would have been infinitely better if they had owned up twenty years ago. But that’s no reason to write off the debt now.
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These posts first appeared on DavidHealy.org