Second anti-depressant maker accused of suppressing evidence that drug causes suicidal behaviour

July 29, 2004
EXCLUSIVE by Adam James

The company which makes Zoloft - one of the SSRI group of anti-depressants - has been accused of suppressing evidence that the drug causes suicidal behaviour among users of all ages.

The American civil lawsuit, filed in the Superior Court in Los Angeles by law firm Baum Hedlund, alleges that Pfizer consistently misled doctors over the safety and efficacy of Zoloft, also known as sertraline.

It now means that the UK's two biggest pharmaceutical companies face charges of fraud over their marketing of anti-depresssants. Last month a lawsuit was filed by New York State attorney general Eliot Spitzer against GlaxoSmithKline, makers of the most widely-prescribed SSRI, Seroxat. It alleges that the company concealed information that the drug caused suicidal behaviour among children and teenagers during clinical trials, and that the company exaggerated its efficacy.

Commentators believe that because the lawsuit against Pfizer has been filed by a private attorney - and not an attorney general - it will carry significantly less influence than that against GlaxoSmithKline. Nevertheless, it does go beyond the charges facing GlaxoSmithKline because it alleges that Pfizer concealed the risk of increased suicidal and violent impulses in Zoloft users of all ages, not only for young people.

The safety of all the SSRI (selective serotonin re-uptake inhibitors) group of antidepressants, is being investigated in the UK by the Medicine and Healthcare Products Regulatory Agency. Last year the agency effectively banned the use of SSRIs - except for Prozac - for under 18 year olds.

The lawsuit against Pfizer, the largest supplier of medicines to the NHS, also alleges the company suppressed evidence of Zoloft's lack of efficacy compared to placebos. Attorney Karen Barth Menzies of Baum Hedlund claims only one out of five of Pfizer's own clinical trials for Zoloft's license application to the US drug regulators, the Food and Drug Administration (FDA), indicated that it was more effective than a placebo.

The lawsuit, filed on Friday on behalf of a nurse, also claims Pfizer suppressed evidence that Zoloft induced withdrawal and dependency and that the company concealed evidence that Zoloft caused a range of side effects including mania, hallucinations, convulsions, self-harm and psychosis.

Ms Barth Menzies said: "Pfizer has promoted the benefits as huge and the risks as minimal in an extremely deceptive way…Once all the evidence comes out it will become clear that Pfizer was well aware of Zoloft's safety and efficacy issues for many years. Despite this knowledge, Pfizer has continued to market Zoloft as 'highly effective'".

"We hope this lawsuit will be a significant step toward exposing the fraud."

A Pfizer spokesman said: "The allegations in this lawsuit are contradicted by extensive clinical data, the personal experiences of literally millions of patients who have been helped tremendously by Zoloft, and many doctors who have prescribed the medicine and attest to its benefits.

"The FDA also has closely evaluated this medicine for more than 14 years and continues to reaffirm that Zoloft is safe and effective.

"It's extremely unfortunate that these sensational and unfounded claims...may create undue concern on the part of those who benefit the most from taking Zoloft."

See also:
July 27, 2004: Warning that Seroxat may increase the risk of suicide in young adults to be issued throughout Europe - but Medicines and Healthcare products Regulatory Agency issues no warning to British doctors, reports independent.co.uk
June 28, 2004: GlaxoSmithKline to publish results of clinical trials on internet in a bid to rebuild reputation after Seroxat controversy - drug firm denies decision is a result of legal action
June 14: Regulatory body to warn some SSRI antidepressants can cause adults to become suicidal
June 7, 2004: Glaxo faces Seroxat fraud lawsuit - claims that firm suppressed results of studies showing Seroxat was no more effective than a placebo and even harmful.
April 4, 2004: GPs 'forced' to overprescribe antidepressants - survey shows 80% of doctors believe they are writing too many prescriptions for SSRIs
March 28: SSRI antidepressants must carry warnings that people might become suicidal while taking them - US drug regulator states

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