New England Journal of Medicine editor: Pharmas don’t disclose enough trial data
Dr. Jeffrey Drazen, NEJM editor-in-chief, told the Associated Press that the three drug firms are not providing enough useful details in their postings on the government-run Web site, www.clinicaltrials.gov. Drazen said their reluctance to provide meaningful information might hamper their ability to have their studies published in important medical publications.
"They (the three companies) are giving nonsense details," Drazen told the AP.
He said a review of the Web site postings was conducted by Dr. Deborah Zarin of the National Institutes of Health, the agency which runs the Web site, at the request of the International Committee of Journal Editors (ICJE). Last September, ICJE members said they would not publish any studies not registered in a public database as they are launched.
Zarin first looked to see whether pharmaceutical companies were giving drugs a distinguishable name since a name is crucial to allow tracking of a medicine's progress through the trial process.
Of the 400 companies with trials listed on the registry, only five neglected to list specific names, often calling the product an "investigational drug," Zarin reported.
Zarin told the AP that 90 percent of the time, Merck did not provide a name while GlaxoSmithKline didn't provide a name 53 percent of the time and Pfizer did not provide a name 36 percent of the time. Eli Lilly and Bristol-Myers Squibb lacked names less than five percent of the time.
According to Drazen, another problem with the submission of information included a failure to clearly outline the primary and secondary outcome measures of their studies. Zarin noted that most companies didn't provide such data. Although the NIH does not require supplying such data, there is space for companies to do so.
Drazen said that Lilly and Abbott are 90 percent in compliance with what editors are expecting and Zarin gave high marks to Novartis for the quality of its disclosures.
Earlier this year, four major international pharmaceutical associations agreed that companies should submit information on their trials to a public registry.
Editors have given the companies until September 13, 2005 to register ongoing trials with the rule applying to new trials starting on or after July 1, 2005.
Drazen said that if the companies don't comply, editors would refuse to publish their studies.
"We think they will want our stamp of approval," he told the AP.