News & Views item - July  2004

 

 

It Can Pay to Have Powerful, Pugnacious and Cluey Friends in Court. (July 23, 2004)

    The State of New York's Attorney General, Eliot Spitzer is not only a party to the states' and City of New York's lawsuit against several large energy companies for excessive CO2 emissions he has also taken on one of the world's most powerful pharmas for bending the truth.

 

As Donald Kennedy points out in his Science Editorial of July 23, "[P]harmaceutical companies often gather favored medical specialists to evaluate, and even tout, the value of a particular drug treatment. Results of clinical trials favorable to the drug and its sponsor are collected, sometimes in the form of a symposium volume or even as a supplement to a specialty medical journal. The U.S. Food and Drug Administration (FDA) has attempted to regulate such sponsored publications in the same way as it regulates advertising in medical or lay journals."  Unfortunately in a recently decided dispute a challenge of  the FDA's authority to regulate the promotion of drugs for use "off label"--that is, for treating symptoms or diseases for which the drug has not been proven effective by the FDA, the court held that the FDA had to permit drug company-sponsored advertisements for off-label use, as long as they were directed at physicians and not consumers. What can and does occur is that clinical trials which are not supportive of a pharma's claims may not be brought to the attention of the public or medical practitioners.

 

Enter Mr Spitzer, who as Science's Editor puts it, "made an amazing discovery last month: The First Amendment to the US Constitution [freedom of speech] is not a defense against fraud! He has sued the pharmaceutical company GlaxoSmithKline for holding back data that may have made the antidepressant drug Paxil look less effective than the successful trials being advertised. That neatly finesses the legal constraints on the FDA, whose scientists should be cheering. And it might finally empty some of those old file drawers."

 

For the record: based on 2003 annual results, GSK had sales of £21.4 billion (A$55.3 billion) and a profit before tax of £6.7 billion ($A17.3 billion), i.e. a before tax profit of 31.3%.