Tysabri faced an unknown destiny when these safety signals were presented to an FDA advisory committee in March.
This unprecedented two-day meeting allowed MS patients to voice their opinions about this “super” monoclonal antibody's potential return to market. The media followed developments closely and Biogen Idec/Elan pushed the product as the financial, regulatory, medical and patient communities observed from the sidelines.
Despite considerable safety concerns presented by leading neurologists, over 40 patients came, mostly to advocate the re-entry of this potentially fatal product in a non life-threatening condition. On the other side of the debate was the family of Anita Smith, who died from contracting PML while taking Tysabri. As her children talked animatedly of their mother's love for life despite her MS, there was not a dry eye in the house. The Multiple Sclerosis Association of America also presented its concerns about this medication for a condition that, relapsing and remitting in nature, was well served by existing immunomodulatory products supported by years of good clinical experience and safety data.
Hours of pro-Tysabri testimonials followed, as thought-leading scientists and physicians listened to patients' pleas for the return of Tysabri. At the end of an emotional first day, the patient voice was clearly in the driver's seat.
However, the question remains: Is this good science and good patient care? If the first rule of medicine is to do no harm, is it appropriate that the power of patient advocacy have so much sway over the insights, experience and training of the medical community? There remain many unanswered questions surrounding Tysabri's safety, but with patient advocacy driving a large part of the demand the rest of the world is watching.
Charlotte Wray is president of Mosaic, an Omnicom healthcare communications agency