In November 2004 the Food and Drug Administration approved use of Tysabri to fight the effects of relapsing/remitting Multiple Sclerosis. Incidentally, I had an appointment with my Neurologist on December 1. It is my opinion that I had not been responding satisfactorily to the Interferon Beta injections that were my primary treatment regiment until that time. I was given a prescription for the infusion of Tysabri every 28 days and began the process of trying to gain insurance approval to begin treatment.
After a month of failed efforts to move the process along I sought the aid of an Oncologist that I had used in a previous infusion therapy. It worked! On February 3 I underwent the first infusion with this drug.
My appointment for the second infusion is scheduled for March 3. It won't happen! The FDA, Elan Corp. And Biogen have pulled the drug off the market, stopped distribution and suspended ongoing clinical trials. Two members of the clinical study have been diagnosed with PML. In one case the patient died and it's my interpretation of the information available that the second individual still suffers from the effects of the disease.
PML is a progressive degeneration of the brain for which there is no known treatment. Just what I want! Another disease that results in progressive degeneration of the brain! Early symptoms seem to mimic many Multiple Sclerosis symptoms (that's my analysis, not a medical professional's) and the diagnostic tools used to identify it are MRI and Lumbar Puncture.
I think it’s too early to react to this! Were there other treatments that provoked this response of the immune system? What is the long term risk associated with this product and what are the long term benefits it offers?
By the way, if you are interested, I have a pretty good explanation of PML I can attach to an email for you. Just add a comment to this Blog requesting it and make sure I’ve got your email address.
The search for a cure continues!