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  • 02/28/2006

Dr. Bob Goldberg on risk, benefit, patients rights, FDA policy, politics … and Tysabri …

As Steve Usdin the Washington Editor of BioCentury ( points outs, “there has been very little debate about the risks associated with delaying or denying access to therapies or who should be empowered to make risk/benefit calculations.” Given the growing transparency of the drug development process, the rapid dissemination of post market information and intense and ongoing involvement patients have in both the clinical trial of medicines and managing an illnesses, the real question is, who should have the right to choose which drugs to use: the political class and their allies in the media, or patients, families and physicians?

Next week when an FDA advisory committee reviews evidence about whether to reintroduce a drug for multiple sclerosis called Tysabri back to market after it was removed in the wake of safety concerns, patients will demand that the FDA take ! into account not only the data about Tysabri’s risks, but the relative risks of taking other medicines such as aspirin or existing MS drugs and the benefits of the new drug itself. Ironically, Tysabri’s safety problems emerged the day when Senator Charles Grassley was holding hearing that sought to blame the problems associated with Vioxx on an incestuous relationship between Merck and FDA regulators. Back then, no one was paying attention to the pain of patients who had to live without Tysabri after taking the drug gave them back their lives.

Now, reminescent of HIV activists, MS patients have taken to the Web to organize en masses to pressure the FDA to respond. They are unwilling to let the political class and the professional fear mongers and those who warn against approving Tysabri because it is not a cure take the right to get the drug from them. Lack of access to Tysabri has caused nearly 8000 relapses — loss of movement, sight, independence — in 28000 patients over the past year. 1300 had relapses so severe that they are now permanently disabled. (Will Chuck Grassley or anyone in Congress hold a hearing on that?)

The FDA’s decision about Tysabri will be it’s most important all year. Jeff Krasner’s excellent piece in the Boston Globe provides a great perspective on all the issues surrounding Tysabri, and his coverage from the very start has, along with Usdin’s, been essential for anyone wanting to get up to speed on how the risks and benefits of medicines debate ought to be addressed. I also urge folks to log into MS Patients for Choice

It will be interesting to see how the media covers this story.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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