Pfizer, GlaxoSmithKline and Merck & Co. are "making a mockery" of efforts to create more transparency in drug clinical trials, according to a prominent medical journal editor.
Jeffrey Drazen, M.D., editor-in-chief of the New England Journal of Medicine, said the companies are not providing enough useful details in their posting on a government trial registry and that their reluctance to provide meaningful information may hamper their ability to have their studies published in important medical publications.
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 drug companies posted at ClinicalTrials.gov, which is run by the National Institutes of Health. He said the review was conducted by Deborah Zarin, M.D., director of ClinicalTrials.gov, at the request of the committee.
"They (the three companies) are giving nonsense details," Drazen said. "They are written in a way that they are trying to hide what they are doing."
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.
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.
Zarin said she first looked at whether pharmaceutical companies were giving drugs a distinguishable name. She said a name is crucial because it allows editors, patients and doctors to track a medicine's progress through the trial process.
Drazen said another problem with the information submitted by three companies included a failure to clearly outline the primary and secondary outcome measures of their studies. For example, a study should say that it is attempting to see if a drug can lower heart attacks over a year.
The editors have given the companies until Sept. 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.
