News - Rules Adopted for Company-Paid Drug Studies

By Gina Kolata
New York Times
August, 2001

Editors of 11 leading medical journals from around the world say they have agreed to a new policy for reporting research sponsored by drug companies.

One of the editors explained that the policy says that they will question papers listing academic scientists as lead authors when the studies were actually designed and the data analyzed by drug company scientists.

The policy is meant to address a practice in which university scientists are used as window dressing, to lend credibility to papers that are really the work of drug companies. The academic scientists’ main role in such studies is to recruit patients and administer experimental treatments. The scientists of their universities are paid for this work.

Dr. Jeffrey M. Drazen, editor of The New England Journal of Medicine, one of the journals that agreed to the new guidelines, said academic scientists sometimes felt they had no choice to but accept such conditions. The company paying for the research tells them that the only way they can have the contract is to agree to the company’s terms.

The journals are keeping the wording of their new policy secret until early September, when they plan simultaneous editorials to explain it.

Dr. Drazen said that when an academic author’s contribution to the research was questionable, the journals had agreed that they might not publish the paper with that author listed as a lead investigator.

He said the journals would have no problem if a drug company that designed a study put its own name on it. The problem is when a study’s authors are authors in name only.

Dr. Bert Spilker, who is vice president for scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America, a trade group, said drug companies should have little problem with such a policy.