FDA Make Another Boneheaded Move on Lemtrada: Meanwhile Patients Suffer

I recently was reading this article and started to get somewhat frustrated while reading it. Basically the FDA recently announced that last December a drug called Lemtrada which is used to treat people with multiple sclerosis (MS) was not approved because according to the FDA the studies were not adequate and well controlled.

The drug Lemtrada is used to currently treated people with leukemia. The drug is an intravenous drug and produced by a company called Genzyme. The drug has been approved in Canada, Australia, and even all members of the socialist European Union (according to this Wall-Street Journal article). One no brainer for the FDA is to have reciprocal approval with other countries-so if Canada or Switzerland approve a drug by their equal FDA than it should be okay for the United States.

When the trials were conducted they found a 50% decrease in symptoms (1,400 patients took this drug). The nice thing about the drug is that you only have to administer it essentially once a year as opposed to taking numerous pills and multiple weekly injections from other MS drugs.  We have to remember that these patients are real people with a real illness who I would imagine spend a fair deal of time worry if they will ever get better. The FDA said the issue with the trial was that it was not double blind (which is the gold standard for FDA trials). However, if you have a serious chronic illness and you actually do get the placebo (sugar pill) and get worse and worse who does that help? Doctors and patients correctly pointed out that Rebif which already FDA approved did not used double blind trials when it was going through approval.

The only thing Genzyme can do now (after it has already spent many years and hundreds of millions of dollars in running the drug trials) is to run a double blind study trial which would take at least 2 years and would cost another $100 million for a drug that nearly every other rational country has approved.

The FDA approval panel should have a rule that states "you must have a loved one, family member, or someone you deeply care about that suffers from the illness from the drug you are trying to decide on". If this where the case I would imagine different results if they actually stopped to think how many people are harmed by the FDA holding back drugs to people with chronic illnesses. Maybe the FDA needs a mental evaluation.