I watched with interested the report on the FDA and the question about this institution's possible need of revamping.
In the late 1980's I lost my grandmother not to old age but to a drug, not well known, that she was prescribed for a bladder infection. Instead, the drug destroyed her bodies ability to make blood. For about four years she had to go to the doctor to get transfusions. Eventually, her body brokedown due to not being able to produce sufficient blood.
I don't recall the drugs name, but I do recall being frustrated that my grandmother literally became a lab rat for a minimally tested drug. She lost.
In my estimation the FDA needs to create an environment not influenced by the big money pharmacutical industry and take extreme pains in making sure drugs are safe and reliable before going to market. Haste makes waste, and in this case of medications the waste is in human lives.
The problem with prescription drugs can be traced all the way to the congress. The notion (as mentioned in your show in the last five minutes) that congress let Drug companies fund FDA research goes to the heart of the problem. The research deaprtment should be independent from drug companies and Government.
The US Congress has sold us out to big business so how can we feel safe taking any medicine. The guy on the film from Pharma made the assertion that the US Congress decided to allow industry money to support the FDA review process. But need we be reminded that it is special interest lobbying on the Hill, including lobbying by Pharma, that drives politics today. What I don't understand is why the FDA can allow reviewers and consultants a dissenting opinion similar to what we see on the Supreme Court. This means that all points of view are on the record and would encourage both accountability and credibility in the review process.
The approval process at the FDA is seriously flawed. In my opinion this has less to do with the speed at which drugs are approved and a lot to do with the FDA's ties to the pharmaceutical industry. An important point which was not addressed during the broadcast is the fact that many of the members of FDA advisory committees are/have been/will be employed by these companies who are seeking approvals. It would be foolish of anyone to believe they are being protected by such a corrupt agency.
The Deputy FDA chief said it so well and I dont think he realized it: "The FDA is QUITE independent from the drug companies" "Quite" is not acceptable for a so-called watch-dog agency. "Totally," as it was before the $500,000 approval charge was implemented should be the ideal choice of words.
I have suffered from rheumatoid arthritis for 9 years. Like most people with this condition, I have tried many medications searching for relief. Last year my doctor suggested Arava. He handed me a one page summary about possible dangerous side-effects. The warning was vague with no statistical data. Since most drugs carry risk, I ignored the warning.
Fortunately, I was not on the drug long and suffered no side effects. But I would never had risked what little health I have on drug with greater risk and no greater benefits. After seeing your program, I feel I was underinformed about Arava's risks. I resent having to play this game with loaded dice.