Here is the latest comments from AG Edwards:
Recent Development 3-18-99:
Again we disagree with the LA Times reports on Rezulin. The LA Times today contained another article on Rezulin and the FDA's handling of this drug. As with the previous article, we do not agree with the implications and conclusions brought forth in the article. We have two main criticisms: 1) The main claim of the article -that WLA's claim of a lower rate of liver problems associated with Rezulin use-is neither substantiated nor proven. 2) As with an earlier petition from Public Citizen, this article simply counts all adverse events reports from patients who were taking Rezulin as Rezulin associated deaths. This is simply incorrect, E.G., A patient who died in a car accident who was taking Rezulin should not be counted as a Rezulin associated death. Our read of the data is this. The number of patients who died, or had a liver death that could be related to Rezulin was 30 on 11-30-98, and had increased to 33 as of 2-3-99. We believe that the rate of liver related problems has in fact declined as WLA has stated. WLA has consistently made one important claim, that in properly monitored patients 0 liver deaths have occurred. However, in conversation with company management today, they have pointed out that the FDA is aware of two cases of patients who did reportedly receive proper liver monitoring, but still had some liver related "problems." The outcome of these patients is not yet known, and we point out that both patients had hepatitis and one had a history of a drinking problem. Clearly if proper monitoring does not catch all potential liver problems before they become serious, this is a negative for the drug and the company. It remains to be determined what if any conclusions can be drawn from these cases. In sum, we still place our bets on Rezulin. We believe that it is a safe and effective therapy for type 2 diabetics who receive proper liver monitoring. Further, we believe that weakness in the share price prior to the march 26 panel review represents a buying opportunity.
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See next post for another update.
Greg J. |
