This article brings up a good point, when a patient has no other choices and the potential of a new drug could offer some relief, what is the verdict at this point? The FDA has turned it's way of thinking around now to being much more conservative on the drugs that are approved.
Do the drug companies present a strong enough case, well they would like to think they do, but in recent months we are now reading stories that lead up to believe that perhaps they are not accurate? We are all looking for transparency and really need to do the right thing. Technology, or lack of, has been a sore spot for the FDA for a while, but it's not the entire problem. Clinical trials do take time and genomics is definitely up there helping out with being able to use smaller groups for a focus and getting results while work is in progress.
The potential life saving technology is getting there and those who need it, want it, I would be the same if in the same position. So where is the happy medium? We all may not know that for some time to come unfortunately as it is not a perfect science by any means, but yet we would all like to think it is. With the potential threatening lawsuits always at hand, do we just stand by to avoid exposure while another life is lost? Just one of many questions and issues we need to deal with. BD
Anna Tomalis was a bright, pretty, 13-year-old girl who liked horseback riding and soccer. During the last few years, she rarely had a chance to think about those things. Since September 2005, Anna battled cancer. And, instead of wringing all she could out of childhood, this courageous teenager tried to get members of Congress to act like adults.
Anna had embryonal sarcoma, a rare form of liver cancer. Surgery and chemotherapy seemed to work at first, but the tumors came back. In March of this year, doctors told her there was nothing more they could do. Last year alone, the FDA rejected five new cancer drugs, including a breakthrough treatment for prostate cancer called Provenge. A panel of cancer experts that advises the FDA on new drug approvals unanimously agreed that Provenge was safe, and voted 13-4 that it was effective enough. But the FDA demanded still more testing that may delay approval for three years.