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Thanks to everyone who have expressed their thoughts so articulately on the subject of corporate motivation with respect to approval of new treatments. Also thanks to Sid Levin for his advertisement of the Parkinson-FDA-Industry initiative. My own view of Pharmaceutical companies is more like Paul's. Significant advances in treatment are a goal, not only for profitability motivations but for humanitarian, professional and scientific motivations as well. Drug company executives after all are people with families, they are often scientists as well as businessmen and women. I have been in contact with Amgen executives regarding the NIL-A trials over the past 2 years, and my impression is that they, as well as the FDA regulators, are motivated primarily by science. They are seeking scientific evidence to prove the efficacy of the medication. Of course this science is sponsored by a public corporation that also considers the payoff when making huge investments necessary to prove effectiveness. Here is where we are at a crossroads. The press release that described the results was issued by Guilford Pharm., not Amgen, according to Guilford Investor Relations to halt the steep slide in their stock price. The stock price of Amgen which is a larger company with a number of successful products, was in the meantime rising on a better than expected earnings report. Still unclear to me is why Guilford would characterize the results as "does not produce a substantial reversal of the motor symptoms of PD" without more qualification that the sample size was small and the trends were in the predicted direction, i.e., the results were not conclusive but positive. Something is missing from this picture. Is the increase of nerve endings of 1.2% and 2.5% for treatment groups vs -.0.15% placebo clinically insignificant? To me this is going in the right direction and given how little is known about halting or reversing the direction of PD, it should be a motivation for further study. (the FDA does not now accept Spect/PET scans as surrogate markers to measure progression anyhow, because it hasn't been established that improvements in these measures are related to functional improvements. Until now there were no safe treatments that could reverse deterioration in these Spect/PET measures. Amgen to its credit has included these experimental measures in the protocol to collect the data necessary to validate these measures). Also 17% and 21% of patients that showed significant improvements in H&Y scores. Who are these people? Remember all participants were < 5 years diagnosed so they were presumably not severely impaired (i.e., had little room for improvement), and adjustment for age and duration the results were statistically significant. The press release did not specify whether it was the older longer diagnosed, younger-shorter-diagnosed, older-shorter-diagnosed or younger-longer-diagnosed segment that was significantly better, but this is an obvious avenue for further study. It is especially important that this medication continues to be tested because of anecdotal reports from participants in the trial that not only motor symptoms were affected but more problematic mood, cognition, and autonomic effects of PD (digestion, smell, etc.) not treatable by sinemet were improved. If only 20% of patients are affected by this medication, it may qualify for "orphan drug" status which provides incentives (certain patent rights, etc.) to develop drugs for small target groups. Amgen has not made a corporate decision to continue development NIL-A. I believe and hope that the Guilford Press Release was a hasty response to disappointing news, not a more calculated signal. Given the facts, Phase III is the next logical step. I intend to communicate these views to my contacts at Amgen. Comments and feedback are appreciated. I would also appreciate private responses from anyone with contacts and information at Amgen or Guilford. Perry Cohen Washington DC www.parkinsonscare.org ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn