AMA calls on FDA for more physician-friendly drug data

Physicians want the agency to step up monitoring and make information readily available.

By Victoria Stagg Elliott — Posted July 11, 2005

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Chicago -- It seems lately that pharmaceutical trial data -- especially adverse events not noted in original studies but that emerged after drugs were approved -- have become all-too-frequent controversies in the news.

In response, the American Medical Association adopted several policies at its Annual Meeting in June in the hope of helping to bring about systemic changes to reduce the chance that such negative experiences will be repeated.

"We really think that we need access to the data and the postmarketing information that comes in as well," said AMA Trustee Rebecca J. Patchin, MD. "It needs to be more than just available. It needs to be accessible so that I can find what I need, and I don't need to spend a zillion hours looking for one small part of information."

According to a new AMA Council on Scientific Affairs report, the Association should urge the Food and Drug Administration to issue its final rule on modifying drug package inserts so that they provide the greatest amount of information in the most useful way. The CSA report also encourages the agency to work with medical societies in order to develop better ways to communicate risk.

Both of these recommendations have a clear endpoint in mind -- to avoid burying physicians in the increasing amount of available data that might not be in a form that is clinically relevant. Delegates also are optimistic that these steps will make it more likely that doctors have the information they need before it reaches the mass media.

"The difficulty in full disclosure to the FDA is that physicians who are in practice don't have the time to dig these things up and look at them critically," said Richard T. Bell, MD, a delegate and pulmonologist from West Reading, Pa. "And when it gets out to the media, they can pick on a minor negative report that may not have any practical significance as far as overall use of the medication."

Physicians said the new policies were key to moving toward reducing the chasm between what is known by the FDA and pharmaceutical companies and what is known by physicians.

"The recommendations are to enhance the transparency of this whole process, particularly as it relates to making available clinically relevant material that affects the risks and benefits of decisions physicians are making," said John F. Schneider, MD, PhD, president-elect of the Council for Scientific Affairs, who presented the report.

In addition to providing available data in a more relevant form, the Association is also urging the agency to take steps to address postmarketing surveillance issues that resulted from the recent dust-ups regarding information about adverse events related to COX-2 inhibitors.

The AMA called for the FDA to carry out targeted postapproval studies more broadly and to more extensively mine drug utilization databases. The Association also wants to monitor the design of any independent drug safety board that might be created by the agency.

Physicians recognized, though, that the FDA could not do this additional data-gathering without more money. Thus, the AMA also urged sufficient funding to allow the agency to carry out this work.

"We need to urge Congress to adequately fund the FDA so they can do their job," said Kathleen A. Weaver, MD, a delegate and internist from Lake Oswego, Ore. "They're asked to do more and more with less and less."

Advancing this to-do list is the latest in a series of efforts by the AMA, which last year called for the creation of a clinical trials registry. Even these steps, however, would hardly be the end of the story.

Delegates debated the potential role of legislation in improving current deficiencies. They also questioned whether the fact that a great deal of the agency's budget is generated by fees collected from pharmaceutical companies creates a conflict of interest.

Future reports from the CSA, which changed its name at this meeting to the Council on Science and Public Health, are expected.

"We recognize that this particular report and previous reports have not provided a final evaluation that will solve all the problems," Dr. Schneider said.

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AMA seeking trial inclusivity

Chicago -- The American Medical Association will urge the government to develop an incentive program, similar to the one that promotes research in children, to increase the participation of minorities as subjects in clinical trials.

Meanwhile, to encourage participation on the other side of the lab bench, the organization intends to provide information to minority physicians about the benefits of becoming a trial investigator. The Association also will call on the Food and Drug Administration to create a minority health committee. Additionally, the AMA will work with other medical societies and research institutions to increase minority participation.

The goal of these strategies is to provide a means to tackle the significant health care disparities suffered by minorities.

"It was not long ago that our colleagues in research finally realized that studying women in clinical trials was a worthwhile endeavor," said Michael J. Gonzalez-Campoy, MD, PhD, an endocrinologist from Eagan, Minn. He was speaking for the AMA Minority Affairs Consortium. "[We want] to create an environment that specifically includes minorities in clinical research."

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External links

"Enhanced Physician Access to Food and Drug Administration Data," Council on Scientific Affairs report, June (link)

"Influence of Funding Source on Outcome, Validity, and Reliability of Pharmaceutical Research," Council on Scientific Affairs report, June 2004 (link)

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