CEPH Message Board - Msg: 4452049

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Biotech / Medical : CEPH

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To: scaram(o)uche who wrote (761)	5/14/1998 4:03:00 AM
From: VLAD	Read Replies (3) of 998

<<the data was inconsistent>> Did you personally review the 1995 study? Did you review the European study? If so then you would see that the patient pool was not consistent. The European study involved more advanced cases and thus a more timely death was the consequence and not necessarily drug failure. The US study clearly demonstrated efficacy of the drug yet the European study did not. Why the inconsistency? Because of inconsistent parameters in the 2 studies. The FDA at the very least should allow the drug to be marketed as an ongoing experimental drug. The patients can decide for themselves if they want to try the drug. If so a very large pool can be studied with a wide and varied range of parameters studied. For example, such a study could conclude that at a certain level of progression the drug may very well be of no help yet it may be very helpful in early onset diagnosis. Lets face it, a pool of less than 500 people (combined studies) is a spit in the bucket. I remember how AZT was initially thought to be worthless. Why? Because it was mainly given to patients with advanced disease. Now it has been clearly demonstrated that combinations of protease inhibitors if given early enough can put the AIDS virus into indefinate remission. I feel that the analogy is valid. Patients who are in the later stages of any terminal disease tend to benefit little from late treatment. Kind of like closing the barn door after the horse runs out. Their is nothing wrong with the FDA being cautious but every drug/disease scenario is not the same. Let the patients decide if they wish to try the drug and at least much more valid information can be collected on efficacy. As Debler said to Reuters because Myo has shown no serious side effects "their would be no harm for the FDA to approve it". Or we can just let 1000s of ALS patients die without finding out the truth about Myo and combination therapy. If I were told that I was going to die and their is a drug or drug combination which may help, I would certainly try the drug regardless of how inconsistent the prior studies were.

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