Healthy Skepticism Library item: 1594

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Newspaper Article

Rowland C.
Hospitals split over role drug firms play: Involvement in tests raises concerns over integrity of studies
The Boston Globe 2005 May 26

Full text:

America’s teaching hospitals, the premier institutions for testing the safety of prescription drugs, disagree sharply about how much control over clinical trial results they should cede to drug companies, according to a study published today.

The findings in the New England Journal of Medicine demonstrate the difficulty political and scientific leaders face as they confront growing questions about hidden drug dangers and the accessibility of data.

The survey, conducted by the Harvard School of Public Health with the University of Massachusetts Center for Survey Research, found that 41 percent of 107 academic institutions questioned accept research contracts with drug companies that prohibit physicians and scientists from independently disclosing trial results.

Fifty percent of the hospitals said they would permit drug companies to write manuscripts detailing trial results for publication in medical journals, and 24 percent said they would allow them to insert their own statistical analyses into manuscripts.

‘‘It raises issues about the integrity of studies that are published in medical journals,” said Dr. Robert Steinbrook, the author of an accompanying perspective article and a national correspondent for the New England Journal of Medicine. He is also an adjunct professor of medicine at Dartmouth Medical School.

Steinbrook called for the standardization of clinical trial contracts to eliminate ‘‘gag rules” that prevent researchers from calling public attention to health dangers. ‘‘This is something that needs to be addressed,” he said.

Research hospitals are heavily reliant on contracts with drug companies and medical device manufacturers for research dollars. Because they finance the hospital studies, companies can exert influence on how clinical trial results are disclosed. Also, scientists employed by drug companies are intimately involved in the design and interpretation of clinical trials.

‘‘Sponsor researchers play a very active role, and they have a vested desire to be an author of the paper,” said Kenneth Getz, a research fellow at Tufts Center for Study of Drug Development, which is funded by drug company money.

Pfizer Inc., the world’s largest drug manufacturer, declined to make an executive available for an interview yesterday. The company has a written policy to disclose ‘‘meaningful” results of clinical trials.

Since disclosures about health dangers posed by drugs like Vioxx and Paxil — after they were approved for sale by federal regulators — disclosure restrictions in contracts have come under greater scrutiny.

‘‘These things can be extremely powerful in influencing the quantity and quality of information that reaches the public,” said Michelle Mello, associate professor at the Harvard School of Public Health, who led the survey of hospitals published today.

Until it was forced to acknowledge negative data in 2003, GlaxoSmithKline kept from the public information about suicidal thoughts among teens who took its antidepressant Paxil. Merck & Co. Inc. tried for years to downplay indications of cardiovascular risk associated with its arthritis drug Vioxx before acknowledging the danger and pulling the drug from the market in September.

In response, editors of academic journals established a policy to publish only the results of studies publicly registered in a database like the federal government’s ClinicalTrials.gov, which is operated by the National Institutes of Health.

But the Harvard/UMass survey, which did not specify which medical colleges and hospitals are willing to accept greater drug industry influence on research, shows the issue entails more than public disclosure of a trial’s existence.

‘‘We have been concerned about the possibility that academic centers may be accepting industry contracts that contain provisions we would find extremely troubling,” said Dr. David Korn, senior vice president for the Association of American Medical Colleges, which is devising a plan for voluntary research contract guidelines for its membership.

Developing a set of universally accepted contract standards will be difficult. Drug companies increasingly favor funding specialized clinical trial centers over academic institutions, which puts pressure on hospitals to compete by offering attractive conditions.

‘‘Companies can find any number of providers and set their terms,” said Korn. Hospitals need to recognize that drug companies do not want to give up competitive advantages, he said.

But they also must establish bedrock principals about publishing positive and negative trial data that are ‘‘non-negotiable,” Korn said.

‘‘Our institutions have to stand up for a very high standard of behavior.”