FDA needs to get real

Tysabri is a MS drug which, in a study of efficacy and safety was shown to reduce clinical relapses by 68% relative to placebo and reduced by 83% the number of new or expanding brain lesions found on MRI. The other drugs used reduced these relapses by about 1/3rd. So, it was definitely of great value to MS patients until 3 patients developed a previously unknown side-effect. Rather than just change labelling, the FDA took it off the market. This was an idiotic response since there are many drugs out there which have definitive clinical benefits with potentially lethal side-effects. In antibiotics, I can think of chloramphenicol and gentamicin plus nearly all the agents used to treat cancer--antimetabolites which are known toxic compounds which we hope are more lethal to cancer cells than normal ones. It is time for the FDA to change the label and put Tysabri back on the market and let the patient choose what risk to undertake for MS.