Wednesday, May 25, 2005

Do Drug Companies "Make a Mockery" of drug trials?

NEJM's Editor in Chief hammers away at the Pharmaceutical industry in a recent article, as quoted by Newsday.com.

Dr. Drazen said that GlaxoSmithKline & Merck are "making a mockery" of efforts to create more transparency in drug clinical trials, according to a prominent medical journal editor.

Dr. Drazen is the EIC of the New England Journal of Medicine. He has said that these and other companies don't provide enough useful details in when submitting information to a government trial registry.

Drazen apparently based his comments on a review of the information drug companies posted on www.clinicaltrials.gov., which is run by the U.S. National Institutes of Health. He went so far as to say, "They (the three companies) are giving nonsense details," Drazen said in an interview on Monday. "They are written in a way that they are trying to hide what they are doing."

Last year, New York state Attorney General Eliot Spitzer sued GlaxoSmithKline for suppressing unfavorable studies of its antidepressants.

Editors say that cannot find out if negative data exists when they are only given glowing manuscripts. The registry is supposed to give editors, doctors and patients a complete picture of a drug's development but that would be difficult if a medicine can't be tracked through its name.


The editors have given companies until September 13, 2005 to register ongoing trials. It applies to new trials starting on or after July 1, 2005.

Drazen said that if the companies don't comply, editors will refuse to publish their studies. He said that other medical journals had adopted the registry standards of the international committee so companies that don't comply may find their choice of publication venues is limited. Drug companies often use studies published in medical journals in their marketing.

For more, go to Newsday.com.