New York Times Looks at Contracts That Restrict Access to Research Data
The New York Times on Monday examined pharmaceutical companies' research contracts with academic institutions, which often give drug makers control over self-financed research data by guaranteeing the companies the rights to the information. Drug makers say that "because they pay for a trial, they own the data it generates," according to the Times. However, the ability of prescription drug manufacturers to withhold data has caused recent calls for mandatory release of clinical trial findings. The Times reports that the issue involves the terms of the clinical trial contracts, the way researchers describe study results and whether the researchers pursue publication.
Research confidentiality and publication regulations vary among institutions, and academic researchers in "well-established fields like cardiology" have more negotiating power, according to the Times. A few years ago, officials from the Association of American Medical Colleges discussed standardizing contract terms with pharmaceutical company officials, but "drug company executives balked," according to the Times. Several studies have found that researchers -- who are often paid a "significant" amount of money by pharmaceutical companies for work related to studies of particular medications -- may "overstate" test results "to please a study's sponsor or a medical journal editor," creating a "potential conflict of interest," according to the Times.
Some academic institutions put restrictions on speaking and consulting fees pharmaceutical companies can pay researchers testing their products. Some researchers and the American Medical Association have expressed support for mandatory reporting of clinical trial results in a government-operated database, and legislation has been introduced in Congress that would require test results to be reported.
Pharmaceutical company executives have said that research contracts are not intended to allow the companies to suppress data but to ensure that all data is properly analyzed before release. Robert Califf, associate vice chancellor for clinical research at Duke University Medical Center, said, "People who are blaming this all on industry are missing the point. I think that academia is part of the problem right now and not part of the solution."
Adrian Dobs, a professor at Johns Hopkins School of Medicine, said, "Most universities compete with each other when it comes to money and budget. We have not been very successful in taking a united front." (Meier, New York Times, 11/29).