What's sad is all the world often knows a certain drug will be approved, all that's required is time. The lives or benefits lost while the FDA screws around because of their methods for approving drugs could be regained without substantial further risk by approving drugs where approval's so obvious far earlier, but placing all kinds of burden on the drug for reporting results in hundreds, or perhaps thousands of patients who use the drug after initial approval.
Whether this is called a Phase IV, or some other term is established. With Drs everywhere having access to the Internet, it could be a simple reporting medium that would allow both the FDA and other Drs. considering use of the drug to determine what's happen with those who've begun to use it after approval. In reality this sort of thing may be more important with drugs that are approved that just barely met some marginal standard.
In reality, I believe faster approval but manditory tracking of all sorts of drugs would greatly lower the cost of trials and would rapidly identify problems, like the ones with Vioxx and Fen-Fen. The key is drug companies couldn't buy the silence of those with negative outcomes, Drs. would have to report the outcome and others could see as well as the FDA. I believe if the problems with Vioxx had been identified earlier it would still be on the market, but only available for very limited duration.
People like Dr Padzur tend to defend the FDA stance on how everything's done instead of looking at how to broaden benefits while maintaining safety. I'm currently involved with two stocks each has a drug which I'd almost guarantee will be approved, the question is, will it happen in the next year, or will it take two or three more years. I'm talking about TNFerade from GNVC, and T-DM1 from DNA, but I hold IMGN which provided the technology to conjugate Herceptin. I know many protesting Dr. Padzur are into DNDN and while Provenge also should be approved, I don't believe its results are as dominent as either of the other two.
Gary |
