Monsanto Roundup Lawsuit

Thursday, November 22, 2012

Glaxo's Paxil 352 Bipolar Trial - Ghostwritten

Who you gonna jail?

Anyone familiar with GlaxoSmithKline and Paxil will know all about the Paxil 329 study that  they [Glaxo] hired a PR firm to draft and, later, persuaded key thought leaders, mainly child psychiatrists to endorse and promote at any given opportunity. The 329 study has been dissected by many who are in agreement that it's a piece of fraud. Read more about the Paxil 329 study here and here.

Not content with one study doing the rounds in various journals and pediatric clinics Glaxo, in their infinite wisdom, hired the services, once again, of a ghostwriting team to pimp out the paroxetine 352 bipolar trial.

"Study 352" was published in the American Journal of Psychiatry (158:906-912; June 2001) and, like all good ghostwritten articles, suggested that Paxil may be beneficial in the treatment of bipolar depression. The study cited Charles B. Nemeroff as the lead author. The name Nemeroff is synonymous in the ghostwriting and kickback field. He's made a lucrative living out of speaker fees and pharmaceutical roundtables, although this is classed as 'honoraria' [ex gratia payment]

Okay, we are all entitled to make a bit on the side, all entitled to be paid for our expertise. When that expertise, however, is constructed, conceived, call it what you will, by somebody else then that honoraria should either be given back, paid to the owner of the said work or given to a charity where the said work/opinion has harmed a person/s. For that one would need a conscience. My opinion, for what it's worth, neither Glaxo or Nemeroff have a conscience.

Ironically, Glaxo hired the same PR outfit, Scientific Therapeutics Information, [STI] to misrepresent information from Study 352. STI also drafted the original Paxil 329 study, specifically Sally Laden.

Just like Study 329, 352 also made unsubstantiated efficacy claims and downplayed the adverse event profile of Paxil.

The original 352 study made the following acknowledgement:

This study was conducted with the participation of the following collaborating investigators and sites: Jay D. Amsterdam, M.D. (University of Pennsylvania School of Medicine, Philadelphia)

Amsterdam has since tried to remove himself from any ties to the study, in fact both he and bioethicist and  lecturer in philosophy, Leemon McHenry, have recently published a study in the International Journal of Risk & Safety in Medicine entitled, "The paroxetine 352 bipolar trial: A study in medical ghostwriting."

The study, available here, [Subscription] concludes:

Corporate malfeasance in misrepresenting the results of clinical trials, especially where ghostwriting is involved, is of particular concern in the field of psychiatry where outcome measures of clinical trials are more subjective and lend themselves to manipulation. We are convinced by our analysis that the GSK-sponsored paroxetine 352 study is one such instance of this practice, although prior examples have also come to light. 

Because few industry-sponsored studies gain public scrutiny and even fewer are ever formally retracted, it is important to make these articles as transparent as possible in order to correct the scientific record and inform the medical community of potential harm.

It's worthy to note that Amsterdam, who was a clinical investigator at the University of Pennsylvania for paroxetine study 352, has received legal support for his Office of Research Integrity [ORI] Complaint from the law firm of Baum, Hedlund, Aristei & Goldman of Los Angeles. Now there's a law firm that gives Glaxo sleepless nights.

Glaxo's CEO, Andrew Witty, is, it appears, refusing to get involved in the retraction of these studies. You can read his statements, which are non-apologetic, and see him blame Glaxo's past on an era, an era that, incidentally, he was very much part of.

It's estimated that between 352's first publication it has been cited hundreds of times up through to 2011.

That ultimately means unwarranted kudos to Nemeroff and a stash of money, through prescription sales of Paxil for bipolar, that today lines the pocket of Andrew Witty, remember his annual salary does not grow on trees, it comes from the sales of GSK products.

British company GlaxoSmithKline are currently embroiled in a legal battle in the UK against a group of litigants who claim that they suffered severe withdrawal reactions whilst trying to wean from Paxil [Known as Seroxat in Europe]. Although GlaxoSmithKline have settled over 3,000 similar cases in the United States, they are, I believe, playing the UK legal system and denying any link to severe withdrawal of Seroxat in UK patients.

Witty, who remember claims GSK's wrong-doing was all part of an era, has refused blankly to meet with UK consumer advocate, Janice Simmons, to discuss Seroxat's addictive qualities and a way to help patients wean safely off the drug [See - GSK’s Andrew Witty in Patient Aftercare Snub]

One thing about this company, they're pretty consistent.