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Antidepressant Doesn't Work, Giant Drug Company Suppresses Results

GlaxoSmithKline staff told not to publicise ineffectiveness of its drug

David Spurgeon

Quebec

 
Same drug banned in United Kindom because of link to suicides.  They are also sued by New York State Attorney General. 

GlaxoSmithKline staff told not to publicise ineffectiveness of its drug

David Spurgeon

Quebec

CMAJ (the journal of the Canadian Medical Association) has published details of an internal document from the drug company GlaxoSmithKline that advised its staff to withhold the findings of a clinical trial in 1998 showing that the antidepressant paroxetine had no benefit in treating adolescents.

The association has publicised the document on its website in an early release of its Analysis column (www.cmaj.ca).

Last year, the drug, which is marketed as Paxil in North America and Seroxat in the United Kingdom, was banned for paediatric use in several countries because of a perceived increased risk of suicide.

The UK Medicines and Healthcare Products Regulatory Agency advised doctors last June that they should not prescribe the drug to patients under the age of 18.

The CMAJ column says the confidential document was prepared by the central medical affairs team, a division of SmithKline Beecham, the company that subsequently merged with GlaxoWellcome to form GlaxoSmithKline. The column says the document gives guidance on two clinical trials, study 329 and 377, whose results were, according to the document, "insufficiently robust" to support application to regulatory authorities for a label change approving Seroxat for use in children and adolescents.

The team recommended the firm "effectively manage the dissemination of these data in order to minimize any potential negative commercial impact."

Study 329, conducted in the United States from 1993 to 1996, showed paroxetine to be no more effective than a placebo, while study 377 showed that the placebo was "actually more effective than the anti-depressant."

The central medical affairs team's document is quoted as saying that "it would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine."

A spokeswoman for GlaxoSmithKline, Jill McKinlay-Morris, told the CMAJ that "the memo draws an inappropriate conclusion and is not consistent with the facts... GSK abided by all regulatory requirements for submitting safety data. We also communicated safety and efficacy data to physicians through posters, abstracts, and other publications."

 

BMJ  2004;328:422 (21 February), doi:10.1136/bmj.328.7437.422-a
http://bmj.bmjjournals.com/cgi/content/full/328/7437/422-a

Other related articles in BMJ:

News
GlaxoSmithKline faces US lawsuit over concealment of trial results.

Owen Dyer
BMJ 2004 328: 1395. [Full text]  

News
GlaxoSmithKline to publish clinical trials after US lawsuit.

Liza Gibson
BMJ 2004 328: 1513. [Full text]  

GlaxoSmithKline faces US lawsuit over concealment of trial results

Owen Dyer   from bmj.com

London

The British pharmaceutical giant GlaxoSmithKline (GSK) is facing a major lawsuit in the United States over alleged concealment of negative trial results involving its antidepressant paroxetine (marketed there as Paxil and in Britain as Seroxat).

The civil suit, filed by New York state's attorney general, Eliot Spitzer, charges the drug company with "repeated and persistent fraud" in concealing the results of studies that suggested that paroxetine was ineffective in treating depression in adolescents. It is the first time a US public authority has pursued a drug company for misreporting trial data.

Five studies have attracted particular attention. Two of these showed no benefit from paroxetine compared with placebo in depressed adolescents. Three showed evidence of an increase in suicidal thoughts and behaviour, though there were no actual suicides.

Mr Spitzer has an internal SmithKline Beecham memo from 1998 which stated that it would be "commercially unacceptable" to admit that paroxetine did not work in children. It went on to say that the company would have to "effectively manage the dissemination of these data in order to minimise any potential negative impact."

The document was published by the journal of the Canadian Medical Association, CMAJ, in February and reported in the BMJ that month (21 February, p 422).

The negative trial data came out when one of the participating researchers, Dr Robert Milin, presented results at the 1999 meeting of the American Academy of Child and Adolescent Psychiatry. He said the company did not try to stop him.

In a statement, GSK said: "GlaxoSmithKline has acted responsibly in conducting clinical studies in paediatric patients and disseminating data from those studies. All paediatric studies have been made available to the FDA [US Food and Drug Administration] and regulatory agencies worldwide. We have publicly communicated data from all paediatric studies. As for the 1998 memo, it is inconsistent with the facts and does not reflect the company position."

The company's share price fell sharply last Wednesday when the suit was announced, but recovered somewhat as analysts predicted that potential damages would be unlikely to surpass $250m (£136m; 203m). Mr Spitzer said off-label prescribing of paroxetine to under 18s had accounted for about $55m in sales in the United States in 2002.

The case has reignited debate in the United States about a national trials registry that would record all clinical trials from the outset. GlaxoWellcome was considering setting up a company trials registry when it merged with SmithKline Beecham in 1998, but it never implemented the plan.

David Fassler, a Vermont psychiatrist who is on the council of the American Academy of Child and Adolescent Psychiatry, said he believed that a national registry would probably be set up in the next few years. "This case is a healthy development."

• GSK's treatment of paroxetine data has also come under scrutiny in Britain, where the Medicines and Healthcare products Regulatory Agency has been investigating the case for nine months. The MHRA has not yet decided whether to take action against GSK, but expects the investigation to conclude in the next few weeks.