A passionate and emotional first day is now over for the Tysabri Advisory Committe meeting. Some preliminary highlights:
- Testimony was heard from MS patients, many tearful, who made the general point that they would risk a potentially fatal side effect for the more certain chance at relief from MS symptoms. Some Examples:
- Heather Smith, a 36 year old mother said, "I know Tysabri worked for me when all other MS drugs failed. Each patient has the right to make their own choice," Smith said.
- MS'er Marcy Canavan said "I have no treatment options left, and the way things are progressing, in a few years my life won't be worth living ... I want Tysabri badly," Marcy Canavan said.
- A particularly poignant comment made by one of the MS patients testifying: "There is a one-in-1,000 chance of developing MS. After winning that lottery, I am fully willing to become one of the 999 who don't develop PML while taking Tysabri"
- Dr. Robert Temple, head of the FDA's Office of Medical Policy, called the testimonies "heart-wrenching" and helped clarify how much risk patients would accept. "I thought it was extremely, extremely useful."
- The National Multiple Sclerosis Society came out strongly in favor of Tysabri and urged its speedy return to the MS patient's toolbox. Dr. John Richert: "We will applaud the addition of this treatment to our arsenal. If the FDA does not approve Tysabri's return to the market, or if it does so with significant restrictions, we will work tirelessly to find ways to satisfy the safety concerns so that more effective treatments can be readily available for the benefit of people with MS."
- The Multiple Sclerosis Association of America came out against Tysabri's return, arguing that more trials are necessary first.
- This should not be relevant, but as many of our readers will ask for this information, here is the corporate sponsorship information for the: MSAA and NMSS.
- The committee seemed highly interested in the potential misdiagnosis of Anita Smith, one of the two PML victims who in time has been revealed to most likely not ever have had MS in the first place. In particular, they were calling into question why she was allowed to participate in a trial for an experimental therapy when her health status was either unclear or in no obvious danger from MS. Tempering things, the chairman of the AC concluded: "It is inevitable that people are misdiagnosed with neurological diseases" Expect more on this salient but offshoot issue.
- The panel should make its recommendation to the US FDA on Wednesday. The FDA generally follows the advice of its expert panels.
Whew, we hope this is helpful. Many thanks to multiple organizations for the sources of the above, including but not limited to Reuters, the NMSS, and numerous on-site reporters. Due to the nature of the meeting, we can't guarantee the quotes are exact but will correct them if informed otherwise.
References
Reuter's Story
NMSS text of speech
