Monday, January 29, 2007

"Not Something We Want to Publicise" - Spin Doctoring Drug Promotion

The British Broadcasting Corporation (BBC) television program Panorama just did an expose that charged that GlaxoSmithKline "distorted trial results of an anti-depressant, [Seroxat in the UK, Paxil in the US, chemical name paroxetine] covering up a link with suicidal teenagers." To quote the BBC's web-page, with some editing:
Panorama reveals that GlaxoSmithKline (GSK) attempted to show that Seroxat worked for depressed children despite failed clinical trials.

And that GSK-employed ghostwriters influenced 'independent' academics.

GSK told Panorama: 'GSK utterly rejects any suggestion that it has improperly withheld drug trial information.'

GSK's biggest clinical trial of Seroxat on children was held in the US in the 1990s and called Study 329.

Child psychiatrist Dr Neal Ryan of the University of Pittsburgh was paid by GSK as a co-author of Study 329.

In 2002 he also gave a talk on childhood depression at a medical conference sponsored by GSK.

He said that Seroxat could be a suitable treatment for children and later told Panorama reporter Shelley Jofre that it probably lowered rather than raised suicide rates.

Emails to Dr Ryan from 2002 asking questions about the safety of Seroxat had been forwarded to GSK asking for advice on how to respond....

An email from a public relations executive working for GSK ... said: 'Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results. Essentially the study did not really show it was effective in treating adolescent depression, which is not something we want to publicise.'

The BBC also published a commentary by Fiona Godlee, Editor of the British Medical Journal.

What is clearly wrong is writers, academics, or clinicians concealing under their coat tails an army of company spin doctors intent on distorting the scientific record.

Legislation is not going to happen soon - the powerful industry lobby will make sure of that. Regulation is still inadequate.

So what can we do to change the blind-eye culture of medicine? In the interests of patients and professional integrity I suggest intolerance and exposure.

We shouldn't have to rely on investigative journalists to ask the difficult questions.
So at meetings, why not slow hand clap any speaker who does not begin their talk with a sentence or slide declaring their conflicts of interest?

And if journals discover authors who are guests on their own papers, they should report them to their institution, admonish them in the journal and probably retract the paper.

Reputations for sale are reputations at risk. We need to make that risk so high it's not worth taking.

I have little to add , except repeating what I have said before. Patients and physicians require the best possible information about benefits and harms of treatments to make the best decisions about such treatments. When those with vested interests in supporting a particular treatment distort the information available to make such decisions, they risk harming patients. Executives of pharmaceutical (and biotechnology and device) companies who wonder why the public and many physicians distrust their companies should look no farther than stories like this. Physicians have an obligation to get the best possible evidence prior to making decisions for patients, and should, as Fiona Godlee pointed out, expose any efforts by those with vested interests to distort or manipulate such evidence.

ADDENDUM (30 January, 2007) See the analysis of this case, as reported in much more detail in the actual BBC telecast, in the Clinical Psychology and Psychiatry blog, focusing on the involvement of Dr Martin Keller, Chair of Psychiatry at Brown University. [Full disclosure: I am on the voluntary faculty at Brown.]

ADDENDUM (1 February, 2007) See additional posts on the Clinical Psychology and Psychiatry blog here, here, and here.

3 comments:

Fiddy said...

You can read more about the dangers of Seroxat on my blog at http://fiddaman.blogspot.com/. You will see through the various articles posted on there that the MHRA have known for some considerable time that Seroxat is not only dangerous in the children population but also the adult poulation too

Bob Fiddaman

Anonymous said...

For the History of Seroxat , and the whole Seroxat story so far, including secret documents, links and research...

Chesk out my blog...

http://truthman30.wordpress.com/

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