Professors offer FDA ethics so bad drugs don't get to public

 

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Carol Forsloff - Avandia is presently under scrutiny for causing increased heart attacks, raising concerns about clinical trials and post-market assessment of drugs after harm has happened, two professors say could be prevented with some ethics rules.

There are growing concerns about clinical trials for drugs that have been approved by the F.D.A, later shown linked to serious health risks like that of Avandia.

Two professors have examined the issue of bioethics and have stepped forward with a new report containing recommendations about what to do to make the FDA more accountable to the public in how it makes its decisions.

Presented on July 9 in a letter report to the F.D.A., the framework is organized around these recommendations, emanating from a group associated with the Institute of Medicine:

• The F.D.A. should determine if questions about possible risks or the risk-benefit balance of a drug or vaccine already on the market are serious enough to justify a policy decision, such as whether to revise the product's label. 


• A randomized, controlled trial of a drug linked to serious side effects should be conducted only when the existing scientific evidence and any evidence from new observational studies still do not supply the F.D.A. with enough data to make responsible policy decisions. 


• The agency should use "regulatory-science" principles and practices that emphasize public accountability and transparency when determining the need for a policy decision — or the need for new knowledge to support a policy decision. 


• Such post-marketing trials to assess the safety and efficacy of approved drugs should be properly designed so that they minimize risk to patients and monitor risks on an ongoing basis. Any risks should first be judged as "acceptable" by appropriate oversight bodies. 


• Lastly, the F.D.A. and relevant oversight agencies should ensure that such trials have a comprehensive and meaningful informed-consent process in place, and one that continues over the course of the trials. Specifically, participants should be promptly advised of developments such as new research findings or changes in clinical practice that could affect their willingness to continue to accept the risks associated with a trial. 

"The letter report was put together principally by Ruth Faden, PH.D., M.P.H., the committee's co-chair and director of the John Hopkins Berman Institute of Bioethics.  She is joined in this effort by

 Steven Goodman, M.D., Ph.D., a professor of oncology in the Division of Biostatistics at the Johns Hopkins Kimmel Cancer Center, the other chair and a core member of the Berman Institute faculty as well.   

"The post-marketing context poses more difficult ethical and design challenges than we could address in this letter report," says Faden, a member of the Institute of Medicine (IOM). "We plan to take on these challenges in more detail in our full report."

With better guidance it is hoped that the FDA will apply better standards for approving drugs so drugs like Avandia don't have to be pulled from the market and safer drugs are made available that the public can trust.