GSK And The Spectre Of Seroxat Study 329


From Dr David Healy’s blog (for full article see link)

http://davidhealy.org/gsks-transparency-and-access-journey/

The Moral High Ground?

GSK are claiming the moral high ground of concern for patient welfare. Have they in the process managed to co-opt groups from the House of Commons to AllTrials who might otherwise hold them to account?

Study 329 is GSK’s most famous clinical trial.  In this a large number of children became suicidal on paroxetine. Antidepressants like paroxetine – thanks to Study 329 but not thanks to GSK – now come with a Black Box Warning that they may cause suicide.

Study 329 was worth roughly $1 Billion to GSK.  It enabled the company to get six months patent extension on Paxil-Seroxat.

The children who became suicidal on Paxil in Study 329 are more likely than others to become suicidal again if exposed to another SSRI.

Against this background:

  • What should a company genuinely concerned about the welfare of patients who have done so much for the welfare of the company (participating in this trial without payment) do at this point?
  • Should GSK’s concern about patient welfare extend to informing the subjects in Study 329 of the link between their treatment and their problems and future risks they may run?
  • Andrew – have you contemplated the possibility that if you don’t inform those affected you are in fact still to this day making suicide more likely for some of those affected?
  • Has GSK – or any pharmaceutical company – ever gone back to any of the subjects enrolled in any of its trials to explain to them what might have happened to them and the role their drug might have played in what happened? Please send known examples.
  • Would explaining to people how their injury arose not be a more telling indicator of concern for patients than an effort to keep identifiers out of the public domain?
  • What would the patients who have participated in clinical trials think was the more important indicator of genuine company concern?
  • What do Flaminia Macchia and Eurordis think would be the most appropriate indicator of genuine company concern?

Confidentiality

Following a legal action taken by New York State in 2004, GSK agreed to post Clinical Study Reports (CSRs) for their pediatric Paxil trials and other trials on the company website along with further details of  their Avandia and other trials on the company website.

Any good investigative journalist could likely identify each of the children who became suicidal on paroxetine from the CSRs available on GSK’s website. Pretty well the only additional details that the patient level data that the company refuses to release contains are the patients’ initials. These could easily be redacted.  This raises the question as to why GSK are so resistant to making the original case report forms (CRFs) available?

The only obvious other details that the CRFs contain not found in the CSRs are adverse effects. Its clear from looking at the CSRs, there are a very large number of mismatches (several hundred) between what the CSRs show and the CRFs are likely to contain.

Testing GSK

There is a team attempting to rewrite Study 329 according to the RIAT process.  See Reading the Riat Act .  The difficulties they are having in getting data out of GSK have been covered by Ed Silverman of Pharmalot.

1boringoldman has also covered this ground and the apparent growing links between GSK and AllTrials, and how GSK are using their model of transparency to block access to the data.

Because there is a mismatch between the CSRs and CRFs, the Study 329 RIATers are at a point where they require the raw data – the CRFs. GSK refuses to hand over the CRFs.

What would the now 35-year-old or so children who participated in Study 329 think should happen at this point?

Coalition Politics

If you are a small player in the scheme of things, you may know just how the world should work but will never get a chance to implement any of your ideas.  If you go into coalition with a bigger power you may get to implement policies you have always supported but have no chance to see brought into being.  Or perhaps you can temper policies your partners might want to put in place that you disagree with.

What do AllTrials think should happen at this point?

– See more at: http://davidhealy.org/gsks-transparency-and-access-journey/#sthash.uC61cabA.dpuf

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