Pharmas Dictate What/How Research Published

Studies Often Omit Ethics Guidelines

Doctors Frequently Don't Get All the Data From Studies

By Sid Kirchheimer

Oct. 23, 2002 -- Your doctor may not be getting all the facts about research on new drugs and procedures needed to make safe and effective treatment choices for you.

That's because guidelines established to ensure that scientists can conduct unbiased research for publication in leading medical journals -- the primary sources of information for many doctors -- are often left out of agreements made between academic institutions and the companies that sponsor these trials.

That's the conclusion of a startling new study by Duke University investigators, who found that medical schools rarely get provisions to protect the independence of their researchers when signing contracts to conduct industry-paid clinical trials.

These provisions are the basis for guidelines used by more than 500 medical journals as the standard for researchers submitting papers for publication.

The guidelines were revised last year by the International Committee for Medical Journal Editors.

"From a consumer perspective, the question is if their doctors are really being informed about all the information -- both positive and negative -- that will impact the benefits of therapies," lead researcher Kevin Schulman, MD, tells WebMD. "Are there really benefits to these therapies, or are they are less than anticipated?"

Medical schools frequently conduct research sponsored by pharmaceutical and other companies because it can generate millions of dollars for the schools. But the Duke study suggests that it's the companies paying for these trials that dictate what and how the research is published, which is later read by many of the world's treating doctors.

"Based on the responses we got, the medical centers generally feel powerless in their negotiations with the industry sponsors," Schulman says. "If they say, 'I'm going to raise the bar in terms of the requirements for my institution,' the sponsors will just go elsewhere to do the trials."

Schulman and his colleagues at Duke's Medical Center and School of Law surveyed 108 member institutions of the Association of American Medical Colleges for their study, which appears in the Oct. 24 issue of The New England Journal of Medicine.

The survey shows that the majority of contracts rarely contained the recommended guidelines: that authors have full access to all data, that data be published regardless of the results, and that an independent committee evaluate the data and safety monitoring.

The bottom line to you: The information your doctor uses from the studies in medical journals may be tainted, the study suggests.

"For instance, there was a paper published two years ago in The Journal of the American Medical Association on the six-month effectiveness of Cox-2 inhibitors [drugs such as Vioxx and Celebrex used for arthritis pain]," Schulman tells WebMD. "But it was a one-year trial. The six-month outcomes that were published proved favorable, but the one-year outcomes in that trial were not. And there have been a series of such questions."

The Duke finding is not surprising to one researcher, who learned firsthand just how career damaging it can be to publish unflattering research. After Nancy Olivieri, MD, discovered that a drug she was researching caused unexpected risks, drug manufacturer Apotex abruptly ended the trial and threatened a lawsuit if she discussed or published her findings. The University of Toronto researcher had signed a confidentially agreement, and her school declined her legal support.

"I'm delighted that (the Duke researchers) have looked at this, but I'm not delighted by their findings -- or surprised," Olivieri tells WebMD.

"The saddest indictment is that medical schools are prepared to surrender their integrity because the next medical school one state over is prepared to surrender its integrity," she says.

"We need to know that the legal frameworks are in place so that all the data is out there in the public domain," says Schulman. "As physicians and consumers, all we know is what is being published. But we don't know what is not published.

What a sponsor has found in its own data may never be shared with the public."

Thanks to

Clinical Trial Registration:Statement  Med Journal Editors

NEJM, 9/04

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