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One would think that with all of Amgen's lawyers -- they sent eight to the Kentucky hearing alone -- they could come up with a waiver form that would protect the company from future law suits. There are no guarantees-- how many drugs that went through clinical trials and were deemed to be safe - turned out not to be so? Or were taken off the market due to safety concerns and later returned, because the risk - benefit ratio weighed in favor of the benefits of the drug? And there is disagreement among the trial doctors about the validity of the safety issues that Amgen cites. Dr. Hutchinson of NYU states : ... two enduring myths continue to surface. First, that the double-blind trial of GDNF was "negative." It was not. While it is correct to say that it failed to meet its preset endpoints, nevertheless, unlike the tissue transplant study, there was a strong signal suggestive of drug efficacy, which is why Amgen continued to prepare for a proper phase III study even after announcing the phase II results. Second, that there continue to be "safety issues," specifically regarding the antibodies and the cerebellar lesions seen in four monkeys. There is now overwhelming evidence that the lesions were caused not by direct toxicity, but by abrupt withdrawal from very high concentrations of GDNF. Regarding the antibodies, these occur with the injection of just about any protein, and were expected in this study. Life-threatening complications are extremely rare. Indeed, we have it on good authority that senior officials at Amgen, who were in a position to speak authoritatively on this topic, did not consider them at all problematic." http://www.alzforum.org/new/detail.asp?id=1221 Linda K. F. Etzold wrote: There is another side to this: A drug company has to be very careful of how it makes experimental Drugs available. Let us say they would agree to make GDNF available to PD patients because they felt it was the right thing to do. Let us also assume that the company would require a waiver from the patients. Sounds good so far. But now, after several months severe side effects show up and some of the patients decide to sue the company, just as they are suing now, but in the opposite direction. It is likely that the patients would win the suit despite the waivers. This would be an unacceptable risk for the company, which is probably why they are taking such a hard line. Especially since there appears to be reason to be cautious based on the test evidence (which may not be complete). But the courts would certainly look at that and conclude that the company was reckless, and that the patients deserve monetary compensation. It would also reflect badly on the public image of the company. ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn