Provir Cure for Diarrhea in Aids Patients |
Shaman Pharmaceuticals Inc. on Tuesday, Dec. 22 said that Aids patients with diarrhea showed a positive response to the Provir Phase III study. The trial showed that patients who took the drug versus a placebo suffered from less Aids-related diarrhea. The phase III trial demonstrated safety and tolerability. In essence, Provir is significant because there is an unmet medical need in people with AIDS whose lives are affected by this devastating syndrome.
Therefore, hopefully this product will be passed by the FDA and available by the summer of 1999. The phone number to Shaman is 650-266-7485.
The FDA is meeting with Shaman in January to discuss what is called the statistical significance of the p (p means probability values in this test). The score Shaman got on the phase III trial was .033. This means about 3 chances in a 100 the results were by chance. In other words the trials were not a one hundred percent pass by the FDA. The point is the product is positive and effective in Aids patients and is likely to pass.
In case it does not pass the FDA needs to be questioned. What good is it to delay this product? There is no other product available that helps diarrhea. Shaman can easily sell billions of dollars worth of this product outside the U.S. to Africa and Indonesia and others. Therefore if the FDA delays this product due to some ambiguity in the test Shaman may sell outside the U.S. This will result in many more dying in a dehumanizing way in the U.S. Their cure delayed by the FDA.
If delayed by the FDA Shaman may commit a portion of Provir to outside sales. This may result in many in the U.S. not able to get it. Therefore a delay of Provir would only hurt the ones who need it, Aids patients with diarrhea who are dying in the U.S.
Aids patients to save their lives would have to travel to countries where Provir is being sold! Anyway, everyone expects Provir to be passed by the FDA due to the favorable results of the phase III trials.
This web-site wants to communicate two things to people with Aids. Provir, if passed, will be available in the summer of 1999. If it does not pass then call Shaman and ask them what countries they are selling it in and go there. Also Shaman has a special extension program. They are helping Aids patients from the phase III trials that still need Provir in this special extension program. If you have Aids with diarrhea involved ask Shaman if their extension program can help you.
Good luck to all. Thank you for coming to this web-site.
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Page Last Modified: 23JAN02