Neblett Beard and ArsenaultOur much-maligned FDA has been caught again in a too-cozy relationship with the drug manufacturers it regulates. Recently through the efforts of trial lawyers, the general public is learning they were once again the unwitting victims of a drug manufacturer putting profits over safety by marketing dangerous drugs.

AstraZeneca International gained FDA approval in 1997 to market Seroquel, their new antipsychotic drug to treat schizophrenia. They have earned billions of dollars, nearly $12 billion in the last three years, from sales of Seroquel which is 10 times more expensive than the older drugs on the market. That same year Study 15, a long-term trial which suggested Seroquel was not better than older drugs already on the market, was essentially silenced by never being published or shared with doctors despite Seroquel failing to outperform the older Haldol in preventing psychotic lapses. Less rigorous studies which had more positive results for Seroquel were not only published, but used extensively in marketing campaigns and television ads aimed at physicians and consumers.

Eight years and billions of dollars in profits later, the public is finally getting access to the results of Study 15. For practicing psychiatrists, the data from Study 15 could have provided important information on safety and effectiveness in treating and controlling the symptoms of agitation, hallucinations and delusion in psychotic patients. A new taxpayer-funded study found that 82% of patients had stopped taking Seroquel because of the intolerable side effects, casting further doubt on its effectiveness.

Amazingly, the FDA has strenuously maintained that it did not have the authority to allow public access to the data. In its 1997 report, the FDA said that Study 15 did not offer useful data on the side effects of significant weight gain, diabetes and metabolic problems.

AstraZeneca astonishingly went even further by explicitly discussing misleading doctors by cherry-picking which studies were published. In 1999, the company even touted Seroquel as helping psychotic patients LOSE weight during an American Psychiatric Association conference!

Seroquel and the infamous Study 15 are just the latest examples of how drug companies can control public access to the research about their products. Large corporate grants, lavish gifts and entertainment, bogus consultancies and underwriting of research by drug manufacturers to medical researchers and physicians further undermine the integrity of the drug approval process. But for the efforts of lawyers representing real life victims, public interest groups and congressional watchdogs, many of these secrets would never have been exposed. We the public are the consumers of these drugs and our safety should be the paramount concern of both the manufacturers and the FDA.