much has been assumed about the 3rd case of PML diagnosed from a deceased patient - while this post is very long it would need to be much longer in order to explain exactly what is wring with the reporting of this case and the pitfalls of accepting the premise of the press release and the ensuing media and analyst community response in short - THIS CASE OF PML (if indeed it is a PML case) CANNOT BE LINKED DIRECTLY TO SPORADIC TYSABRI USE - my specialty is pathology and virology - and this reaction to this news is completely overblown this patient had too many other risk factors for PML given the (1) the patients age (2) the treatments that the patient had (3) the length of the treatment the patient received (4) the length of the disease and severity (5) the diagnosis of a tumor given the fact that JC virus can be found at a high rate in brain tumors (6) the small amount of tysabri given (7) the fact that tysabri treatment was only given in two spurts 3 months and 5 months separated by 9 months (8) the number of tysabri patients that have gotten 8 months of treatment is very large and not even a hint of immune suppression has been found in any of them (9) the fact that for PML to occur you need profound reduction in T cells or a complete T cell anergy to JC virus to get PML to occur and given that in the absence of prior immunosuppression this has never occurred in any tysabri treated patients given the dosing - then remember this in order for PML to occur any patient needs a very low T cell count as occurs in AIDS, CLL, and certain leukemia or a complete lack of a T cell response as occurs with severe or long term treatment with immunosuppressive agents (which this patient had ) - t cell activity testing could alleviate the risk of PML cases 1.THAT BEING SAID ALL ELN AND BIIB HAVE TO DO IS TEST T CELL ACTIVITY IN PATIENTS THAT ARE RECEIVING TYSABRI - AS LONG AS T CELL ACTIVITY IS GOOD THEN NO PATIENTS WILL EVER GET PML 2.THIS TYPE OF TESTING IS VERY SIMPLE AND CAN BE DONE QUICKLY AND CHEAPLY 3.THUS BY TESTING PATIENTS TO MONITOR THEM BEFORE THEY BECOME IMMUNOSUPPRESSED ELN AND BIIB CAN SAFELY PREVENT PML IN ALL CASES - THUS BECAUSE OF ITS EFFICACY TYSABRI CAN STILL BECOME A BLOCKBUSTER DRUG YOU JUST NEED TO TEST PATIENTS FOR TOO MUCH IMMUNOSUPPRESSION 4.I WOULD HOPE THAT BIIB AND ELN HAVE ALREADY COME TO THIS CHEAP AND SIMPLE TEST THAT WOULD PROTECT ALL POTENTIAL TYSABRI PATIENTS FROM PML AND ALLOW THEM TO ENJOY THE SUPERIOR EFFICACY AND QUALITY OF LIFE THAT TYSABRI CAN AFFORD THEM
Thanks Pin, unfortunately, this is a runaway train. It would be nice if both companies plus a representative of the FDA would elaborate on the findings in a press conference. I fear that capital investments in drug research will dry up. It will be a catastrophe for R & D, but in the long run, a catastrophe for health care.
What the longs don't seem to want to talk about is the viability of ELAN without T. All this talk about the medical opinions do not mean anything right now. One fact that is certain, is for good or bad reasons T is NOT coming back any time soon. Based on that fact it is very possible based on projected sales and the current condition of the balance sheet ELAN won't survive.