September 14

AHRP Press Statement – FDA & SSRI Suicide Risk 9/14/04




The FDA & Concealment of Suicide-Related Risks of Antidepressants


September 14, 2004


Vera Hassner Sharav, President


We are witnessing the unraveling of a system that was intended to ensure that marketed drugs met high safety standards; that physicians were informed about potential, serious adverse drug effects – so that they would prescribe judiciously; and that the integrity of the scientific literature was preserved. But that system has been hijacked by the drug industry – which has infected medical practice and medical research with detail men and informercials that make false claims while manipulating partial data to conceal adverse drug effects.

The issue in the US was propelled by the irresponsible promotion of SSRI antidepressants for children with tragic, but foreseeable consequence. The issue has been brought to a head by recently surfaced company documents that shatter the credibility of company-controlled data. However that data has seeped into the scientific literature. The FDA’s complicity in the concealment of evidence showing failed test results with emergent suicide-related behavior has outraged parents and bewildered physicians. Two congressional committees have charged the FDA with stonewalling, intimidation of its employees, and concealment of evidence. This agency cannot, under its current leadership, lead the way toward resolving the current credibility crisis in medicine.

The real problem confounding the integrity of clinical trial findings and the significance of the adverse incidence reports would largely be resolved if drug manufacturers did not have quasi-total control over trial design and subject selection, and total proprietary possession of the data and over its release. Understandably, public trust in medicine has been eroded.

It is no coincidence that those invited to make presentations continue to conceal evidence of adverse drug effects, apparently with FDA’s blessing.

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