Originally created 05/26/05

Drug makers have a hand in studies



Many U.S. medical schools are willing to give companies that sponsor studies of new drugs and treatments considerable control over the results, according to survey results that some doctors found troubling.

Half of the schools said they would let pharmaceutical companies and makers of medical devices draft articles that appear in medical journals, and a quarter would allow them to supply the actual results. But academics draw the line at gag orders that keep researchers from publishing negative findings, according to the study, published today.

"This is totally beyond reasonable practice. What you're seeing here is a willingness by some institutions to give more leeway than they should," said Dr. Harlan Krumholz, a Yale University cardiologist and epidemiologist who was not involved in the survey.

Private industry funds more than two-thirds of medical research at U.S. universities, a situation that has led increasingly to conflict-of-interest suspicions. Two decades ago, the federal government was the main benefactor.

The study, led by Michelle Mello of the Harvard School of Public Health, appears in today's New England Journal of Medicine.

Harvard researchers sent surveys to the nation's 122 accredited medical schools to gauge what kinds of standards exist between researchers and sponsors. All but 15 responded.

The researchers did not directly establish exactly how much control universities actually give to companies.

But the medical schools overwhelmingly agreed that they would not enter into contracts that would allow companies to edit research articles or suppress negative results. The schools were split on other issues. Fifty percent would allow companies to draft research papers, while nearly 25 percent would let them provide the data.

Three-fourths had disputes over payment after a contract was signed, and 17 percent argued over access to data.

"These results are really bothersome," said Dr. Jerome Kassirer, a former editor in chief of the journal and the author of a book about conflict of interest in research. "Some investigators may be willing to accept constraints just to maintain good relations with the company," said the doctor, who had no role in the survey.

The Pharmaceutical Research and Manufacturers of America, a trade group, insists that corporate sponsors do not interfere with researchers' independence.

The group publishes voluntary research guidelines stating that companies will sometimes help analyze and interpret results and have the right to review articles before publication.