PR View by Charlotte Wray

Share this article:
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

Share this article:
You must be a registered member of MMM to post a comment.

Next Article in Features

Email Newsletters

MM&M Future Leaders

Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Headliner: HealthSpot's teleconnected CEO

Headliner: HealthSpot's teleconnected CEO

Steve Cashman, Founder and CEO, HealthSpot

Recruitment: The New Breed

Recruitment: The New Breed

What do healthcare agencies really want when it comes to potential employees? The answer to that question is in a constant state of flux, as technologies, clients' changing demands and ...

Read the complete September 2014 Digital Edition

Read the complete September 2014 Digital Edition

Click the above link to access the complete Digital Edition of the August 2014 issue of MM&M, with all text, charts and pictures.