Friday, March 07, 2008

British Government Concludes GSK Suppressed Paxil (Seroxat) Data

Last year, we summarized the results of a BBC investigation broadcast on the television program Panorama 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." (See also the links in that post to extensive discussion on the Clinical Psychology and Psychiatry Blog.)

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has just completed an investigation, and it is fitting to quote the BBC story about its results.

It comes after the drugs regulator announced GlaxoSmithKline would not face criminal proceedings over claims it withheld information on Seroxat.

But they warned GSK should have been quicker to raise the alarm on the risk of suicidal behaviour associated with the antidepressant in the under-18s.

GSK has rejected claims it improperly withheld drug-trial information.

The Medicines and Healthcare products Regulatory Agency (MHRA) received data from clinical trials in May 2003 showing that patients under 18 had a higher risk of suicidal behaviour if they were treated with Seroxat than if they received a placebo.

Data also showed that Seroxat was not effective for treating depression in children and adolescents.

But Professor Kent Woods, MHRA chief executive said they were disappointed GSK had not given them information earlier and that drugs firms had an "ethical responsibility".

"I remain concerned that GSK could and should have reported this information earlier than they did.

"All companies have a responsibility to patients, and should report any adverse data signals to us as soon as they discover them.

The government decided not to pursue criminal charges, mainly because of "important weaknesses in drug safety legislation in force at the time."


Health minister Dawn Primarolo said the government would take immediate steps to secure a strengthening of the law in the UK and Europe.

She also said they wanted to make it clear to all pharmaceutical companies that, "notwithstanding the limitations that may exist in the law, they should disclose any information they have that would have a bearing on the protection of health".

The Guardian reported the forceful opinions of the [UK] Mental Health Foundation chief executive, Andrew McCulloch,

It is totally unacceptable to hear that, when information can be made available at speed, young people may have taken their own lives due to a lack of transparency by a pharmaceutical company.

Woods further commented in another article in the Guardian,

I really feel there is an ethical obligation that pharmaceutical companies ought to recognise and it seems to have been lost. Twenty years ago I was a prescribing doctor and I took it for granted that if there was information relevant to the drug I was going to prescribe, then it would be available. We're talking about something which has direct relevance to health and safety.

The Guardian also noted that Woods "could not rule out the possibility that other companies were sitting on unpublished data that could cause them commercial damage."

So, in case there was any doubt, based on this UK government report, it seems very clear that GSK suppressed data about the adverse effects of Seroxat in an effort not preserve sales. This was a blatant effort to put company profits ahead of patient well-being and a slap at the integrity of the clinical science data base. This has hardly been the only case of suppression of clinical research data because it reflected poorly on some company's products or services.

And pharmaceutical executives wonder why no one trusts them anymore?

I doubt there is any way to secure the integrity clinical research short of banning all involvement by corporations with vested interests in having specific research studies come out in ways that favor their products or services.

See also the forceful comments by Dr Aubrey Blumsohn on the Scientific Misconduct Blog. He called it "a day of shame."


Anonymous said...

Suppression of unflattering data as illustrated in this post illustrates the lack of others from such pharma companies from being proactive about such matters, which should be manditory for the protection of the public health. Yet, a corporation is a coporation, so profits and image, however fictitious, remain the focus of thier existence.

Anonymous said...

This comes as we have this development

March 7, 2008, 2:19 pm

LabCorp CEO: Tests Could Slice Market for Cancer Drugs

Posted by Jacob Goldstein
Some drug companies are betting on the future of targeted medicine, hoping to improve outcomes by using high-tech tests to figure out which patients could benefit from a given drug. But what if a diagnostic test comes along and shows that a drug that’s already been approved for a disease may not work well for some patients?

And from the March 8, 2008, WSJ we find Anemia Drugs Face Scrutiny From FDA Panel where the questioning of the use of these drugs does not appear to improve outcomes and may in fact promote tumor growth in breast cancer.

The list goes on and on of drugs that once they were released to the general population we find the results to be marginal or suspect at best.

Device makers are also being questioned about claims, in a March 4 WSJ article the use of the Smartlipo system was questioned with this quote summing up the article:

"Smartlipo is a marketing gimmick to get people through the door" says William P. Coleman III, editor of the monthly journal of the American Society for Dermatologic Surgery.

The drug and device manufacturers ability to market or spin these results will hopefully decrease as new statutes on data reporting and the general flow of information will increase due to such things as the internet.

Steve Lucas