 |
 |
In order for a drug to be approved by the FDA, it must pass a series of critical tests which are reviewed by a team of scientists. These include chemists who review the synthesis and manufacturing processes, and often perform the quality control in its own laboratories. Pharmacologists look at the biometabolic pathway(s) of the drug through the system, MD's review clinical studies for efficacy, and the statistician verifies adherence to proper protocol. Should the manufacturer fail to provide satisfactory documentary evidence to satisfy the requirements, it will be asked to to so. The sooner these are given, the sooner will the agency be able to make a decision (approve?) on the drug. A guide to these criteria for drug approvals are regularly published in the Code of Federal Regulations. Most editors of reputable scientific publications throughout the world frown upon publishing the same study and data more than once although these could be presented orally at various technical meetings. Hype of a particular drug by a manufacturer does not add an iota to the approval process. Michel Margosis 'Carpe Diem' "Jorge A Romero, MD" wrote: > ..........It is interesting that the data presented in all of those sites is > the data of Dr. Olivier Rascol, professor of pharmacology at the Centre > Hospitalier Universitaire, Toulouse, France. > > He has been working on that data obviously since 1996, when he presented the > six month results at the American Academy as "preliminary results." The same > data has been presented at the American Academy in 1998 and in 2000, as well > as in the International Congress of Neurology. IT IS THE SAME STUDY - only > one study. > > That study has been published and republished and republished - all under the > auspices of Smith Kline Beecham. > > The facts speak for themselves.