Industry Gags Academic Medicine

Public outrage over the dangers of using antidepressants in children and Merck's Vioxx was stoked by the fact that the drug companies suppressed the results of clinical trials signaling those problems. With the drug and biotechnology industries now sponsoring almost 70 percent of all clinical trials, these flagrant abuses raise the broader question: Has the industry takeover of clinical testing of new drugs systematically undermined traditional academic values like freedom to publish, freedom to share results and intellectual honesty?

Apparently it has. According to a new survey published in this week's New England Journal of Medicine (subscription required), fully half of all university medical center administrators allow industry sponsors to draft the initial manuscripts that describe the results of clinical trials conducted by their faculty.

And while 85 percent of administrators wouldn't approve contracts that allowed industry to revise the final manuscript or decide whether or not the results got published, 41 percent thought it was okay to prohibit sharing the data. Moreover, a large majority signed agreements pledging secrecy as long as six months after the trial was completed.

An accompanying perspective article, "Gag Clauses in Clinical-Trial Agreements," highlights the need for the Fair Access to Clinical Trials Act, which is sponsored by Senators Chuck Grassley (R-Iowa) and Christopher Dodd (D-Connecticut). The proposed law would ban clinical trial research contracts that limit or unreasonably delay the publication of clinical trial results or their discussion at scientific meetings.

Author Robert Steinbrook holds out little hope for medical schools voluntarily adopting stricter guidelines. Competition for industry support -- which is increasingly going overseas or to private contract research organizations -- will make it very difficult for them to enforce voluntary guidelines, he writes.