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, adding that could lead some important medical publications to avoid publishing their studies.
Dr. Jeffrey M. Drazen, the editor, said that Pfizer Inc., GlaxoSmithKline PLC and Merck & Co. are not providing enough useful information on clinical trials they register with the government. Last September, the members of the International Committee of Medical Journal Editors said they would not publish any studies that are not registered in a public database as they are launched. Drazen's comments came as the editors delivered more details about what they expect from pharmaceutical companies. The group is asking for 20 disclosures, including what each study is designed to evaluate, how many patients will be studied and who is funding 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 U.S. National Institutes of Health. He said the review was conducted by Dr. Deborah Zarin of the NIH at the request of the committee. Zarin couldn't be reached for comment.
"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."
The editors created the policy after some drug companies were accused of stifling negative data from clinical trials. Last year, New York state Attorney General Eliot Spitzer sued GlaxoSmithKline for suppressing unfavorable studies of its antidepressants. He also asked Forest Laboratories for information about studies of its antidepressants.
Meanwhile, trial lawyers have accused Merck of hiding negative information about Vioxx, the pain killer it withdrew from the market last year because a study showed it doubled patients risk of heart attack and strokes.
Drazen said some of the problems with the information submitted by three companies included a failure to state the number of patients in trials and to clearly outline the primary and secondary goals of their studies. He noted that most other companies have complied, but recently had started to follow the lead set by the three companies he criticized.
Drazen said that Eli Lilly & Co. and Abbott Laboratories are "90 percent in compliance" with what the editors are expecting.
Drug companies are legally required to register trials dealing with serious or life-threatening diseases to the NIH site. But since the controversy over trials, companies have been listing various types of studies on the site. Some companies have also begun listing the trials on their own web sites.
Earlier this year, four major international pharmaceutical associations agreed that companies should provide submit information on their trials to a public registry. The U.S. association, the Pharmaceutical Research and Manufacturers of America, recommended its members list trials on the NIH site beginning in July..
The editors have given the 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.
"We think they will want our stamp of approval," Drazen said.
Merck spokeswoman Janet Skidmore said the company didn't agree with Drazen's characterization of its entries on the government web site.
"We have done everything we can to expedite medical information and enhance transparency," Skidmore said.
Glaxo spokeswoman Mary Anne Rhyne said the company has listed 55 ongoing trials on the NIH site as well as 400 studies on its own site. Rhyne said the company intends to supply journal editors with all the trial protocols along with any manuscript for publication so the editors can see the article accurately represents the study conducted.
Pfizer didn't return calls for comment.