As new treatments, drugs and medical devices come to market the FDA is charged with making sure that they are both safe and perform as represented. Products that come under review include items such as human and animal drugs, blood and other biological products, medical devices, and foods. The process of evaluating these products has [...]
On the Prostate Problems Mailing List there has been some recent discussion and a large amount of confusion expressed about the need for and importance of surrogate end points for drug and treatment approval. I attempted to make a very simple clarification and recommendation about surrogates. Here it is, but slightly modified ……. Maybe I [...]
I want to share some of the issues that I have with the FDA and the processes it uses for drug and treatment approval. The FDA demands that a drug, to show efficacy, be tested first in animal models that often are not relevant to humans. Then when the drugs are approved for human trials, [...]
According to the American Cancer Society, prostate cancer claims approximately 27,000 of us each year, the vast majority of our deaths are a result of recurrent metastatic disease. Metastatic prostate cancer occurs when tumor cells spread to other locations in the body and start to grow. Currently, when you start Chemotherapy the only way to [...]
To many people’s surprise on Friday the FDA approved Avastan in combination with the chemotherapy drug Paclitaxel for the treatment of breast cancer. Why was this a surprise? The FDA’s advisory committee voted 5 to 4 against approving the drug. In the clinical trial Avastan did not demonstrate a statistically improved survival rate. However, it [...]