Journal Editor Blasts Drug Firms’ Trial Data

The editor in chief of the New England Journal of Medicine accused three of the largest drug companies of “making a mockery” of efforts to create transparency in clinical trials, saying that could lead some important medical publications to avoid publishing their studies.

Dr. Jeffrey M. Drazen, the editor, said Pfizer Inc., Merck & Co. and Glaxo-SmithKline were not providing enough useful information on clinical trials they registered with the government.

In September, the International Committee of Medical Journal Editors said they would not publish studies that aren’t registered in a public database as they are launched. Drazen’s comments came as the editors offered details about what is expected from drug companies.

The group is asking for 20 disclosures, including what each study is designed to evaluate, how many patients will be studied and how the company is sponsoring the research.

Drazen based his comments on a review of the information 10 drug companies posted on www.clinicaltrials.gov, which is run by the National Institutes of Health. The review was conducted by Dr. Deborah Zarin of the NIH at the committee’s request. Zarin couldn’t be reached for comment.

The three companies “are giving nonsense details,” Drazen said Monday. “They are written in a way that they are trying to hide what they are doing.”

The editors created the policy after some drug companies were accused of stifling negative data. Last year, New York Atty. Gen. Eliot Spitzer sued Glaxo-SmithKline, accusing it of suppressing unfavorable studies of its antidepressants.

Drazen said some of the problems with the information submitted by the three companies included a failure to state the number of patients in trials and to clearly outline primary and secondary goals of their studies. He noted that most other companies had complied but had started to follow the lead set by the companies he criticized.

Drazen said that Eli Lilly & Co. and Abbott Laboratories were “90% in compliance” with what the editors expected.

The editors gave the companies until Sept. 13, to register continuing trials. It applies to new trials as of July 1.

Merck spokeswoman Janet Skidmore said the company didn’t agree with Drazen’s characterization of its entries on the government website. “We have done everything we can to expedite medical information and enhance transparency,” she said.

Glaxo didn’t have a comment. Pfizer didn’t return calls.