Managing Risk So You Don't Have To

The Wall Street Journal editorializes on the impact that the FDA and the threat of litigation is having on people with MS:

"Every day I'm a little bit worse," Audrey Greenfield tells us. The former New York law partner used to travel the country representing real estate developers. But the multiple sclerosis that she first noticed 15 years ago when she lost coordination in her right foot has now progressed to the point she needs a wheelchair. And she isn't comforted by the fact that she's being denied an effective treatment by the Food and Drug Administration, which is once again harming patients with overcaution.

The therapy in question is Tysabri, and for many MS patients it appears to halt progression of the degenerative neurological disorder. But a year ago -- just months after it was approved -- corporate partners Biogen and Elan "voluntarily" withdrew their drug because of FDA pressure and litigation fear after two patients developed a rare brain infection. That infection might have been linked to Tysabri, since the drug works by suppressing parts of the immune system. But these patients also had other immuno-suppressive therapies, and in any case the MS patients were almost all willing to run the risk.

They are willing to run the risk. But the FDA won't let them:

But shortly before the deadline, the FDA announced it would take a 90-day extension until the end of June because of concerns over Tysabri's "risk management" plan -- a preposterous excuse given that Tysabri is delivered by injection and only under the supervision of doctors. With its delay, the FDA is denying very-well-informed doctors and patients the freedom to "manage" the risks of untreated MS. "I haven't had any treatment in over a year," says Ms. Greenfield, who got one injection of Tysabri before it was withdrawn.

Bartira Tibertius of Chicago faces the same predicament. She received Tysabri for a full 28 months as part of a clinical trial. "I was doing great. I even forgot that I was sick," Ms. Tibertius, a language teacher and translator, tells us. "But now I'm getting very, very scared. It's deteriorating and I know that," describing numbness and tingling in her hands, arms, feet and face. As for any possible risks from the drug, she says, "I'm more scared of not having Tysabri than having Tysabri. If you told me the Tysabri would shorten 10 years of my life I would do it. I want quality of life, not quantity."

Her risk-benefit analysis is backed by the latest scientific evidence. Several recent studies reported in the New England Journal of Medicine conclude that, among other benefits, Tysabri appears to cut the number of new or expanding brain lesions in MS patients by 83%, and for many induces near-complete remission. Yet the FDA was unable to get its act together and meet its March deadline. It's still likely that Tysabri will return to the market, but the agency's apparent nonchalance in the face of progressive neurological damage is a sad spectacle.

Indeed. The role of the FDA should be to protect consumers from being exposed to unknown side effects and complications from drugs. It should not be to prevent them from making informed decisions and taking calculated risks to improve their health.