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:: Thursday, May 22, 2003 ::

The FDA Story

Jim Babka of a group called Downsize DC (great name) documents how the FDA hurt more than it helps. His story is called How the FDA Helped Kill My Dad. Here's a teaser:

His cancer started as a renal cell carcinoma (kidney) that spread to a vein, and from there to the rest of his body. Carcinomas produce a tiny vascular system of their own that steals blood flow from the organ they inhabit. They also produce dramatically increased amounts of a substance called COX-2. Inhibiting COX-2 retards the creation of the cancer's vascular system and starves the tumor.
COX-2 also seems to play other key roles in the development of cancer cells, but no successful, cancer-specific COX-2 inhibitors are on the market. Instead, doctors rely on chemotherapy and radiation.
Alas, a COX-2 inhibiting cancer drug does exist. It started its clinical trials for FDA approval in 1999. In Phase I, the FDA concluded that the drug Endostatin (by Entremed, Inc.—NASDAQ: ENMD) has no apparent toxicity. Compare that with chemo or radiation. The drug is currently in Phase II of clinical trials. The research, much of which I studied in my father's final weeks, shows great promise, but the FDA wouldn't let my father have it.
This drug might have saved my father's life, and it almost certainly would not have killed him, but the cancer certainly did.

Babka goes on to cite studies that show tens of thousands have died while waiting for various drugs to be released by the FDA. It makes for worthwhile reading.

:: Walter 6:37 AM [+] ::

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