WSJ: The FDA and MS

Wall Street Journal ^ | April 7, 2006 | Editorial

[OESY]

...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... 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....

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....

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.

One lesson is that Tysabri should never have been withdrawn in the first place, when a "Dear Doctor" warning letter would have sufficed.... We hope Andrew von Eschenbach, the latest nominee to head the FDA, won't follow Mr. Crawford's lead. The FDA badly needs public leadership to explain that almost all live-saving and life-improving drugs do have some risks....

[dawn53]

I'm not upset by the FDA's "caution."

In the first place, it wasn't the FDA that suspended the drug, it was Biogen and Elan.

Since they suspended it, and after the testimonies before the FDA, some things need to be worked out, at least IMHO.

A protocol for treating exacerbations (since further immune suppressants are needed during an exacerbation), a protocol for testing should PML be suspected (during the trial when PML was mistaken for an exacerbation is evidence of that), a recommendation as to which type of MS the drug will be used for (it was only tested for RRMS) and numerous other explanations.

The trial was actually never completed, so there are unknowns. And since Tysabri is a monoclonal antibody, and with that latest "disaster" in England with another monoclonal antibody...information and recommendations are our friends, not our enemy.

I'll be glad to see another MS drug approved. But there were so many "sketchy" things surrounding the Tysabri trial (not the least of them being the woman who died evidently didn't even have MS and was admitted to the trial with an EDSS of zero)...I think the FDA is wise to exercise caution.

[hummingbird]

Did you see the recent thread about Copaxone where the dose was doubled with good results?

[dawn53]

Yes, I read it, sounded good because there were no extra side effects with the doubled dose. Sounds promising.

I use Betaseron, I've never had an issue or problem with it and it seems to keep me "stable."

But some of the new drugs in the pipeline look promising, especially the oral ones. :)