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January 23, 2008

Supreme Court makes correct decision on experimental drugs

This analysis is solely the work of the author. It has not been edited or endorsed by GLG.
Analysis By:
Eric Whitman, MD, Medical Director, Office of Grants and ResearchEric Whitman, MD
Medical Director, Office of Grants and Research, Atlantic Health System Inc
Implications: The Supreme Court, in refusing to hear arguments in a case brought that would make it easier for patients to gain access to non-approved drugs, brought a legal end to the request of the Abigail Alliance. This suit would have circumvented the drug approval process while leading to patients receiving therapy on the basis of hope and hype, not results. We may not like all the FDA rulings but we must make sure that patients receive safe drugs with proven benefits. As frustrating as it is for patients and their families, the possible complications of loosening the restrictions on these experimental therapies far outweigh the potential benefits.

Analysis: As a physician, I am often asked why a patient can't receive the next great drug they have read about in the Wall Street Journal, or Family Circle, or even Newsweek. The answer is, and has to be, that experimental drugs are only available under agreed upon, regulated, and approved clinical trials, so that any potential benefit is most readily identified, while minimizing the risk to patients.

Other Analyses of the Same Source Article:
Terminally ill patients cannot access drugs not approved by the FDA: ethical and legal issues are established
January 23, 2008, Author: GLG Expert Contributor
Dying patient denied access to experimental drugs is contrary to common sense and discovery of new treatments.
January 23, 2008, Author: Carlos Dujovne, MD, Professor of Medicine and Director, OREGON HEALTH & SCIENCE UNIVERSITY - CC
The Supreme Court got it right
January 22, 2008, Author: GLG Expert Contributor
Outsourcing of compassionate use of drugs?
January 18, 2008, Author: Dan Streja, MD, Clinical Professor of Medicine, University of California, Los Angeles

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