On the American Liberty Foundation's new Downsize DC website, Jim Babka has a nice, very personal, and fully sourced article on the FDA and the harm it causes:
http://www.downsizedc.org/cases/fda.shtml
http://www.downsizedc.org/cases/fda.shtml
My father died of cancer in April 2003. He was only 64 and in apparent good health until his cancer diagnosis. He watched his diet, got regular exercise, had no vices like alcohol, drugs, or tobacco, and lived a conservative lifestyle. He was neither depressed, nor repressed. His father had lived to 79, with a brother who lived to 83, and another who's still alive at 86. I took it for granted I'd have another 15-20 years with my Dad.
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.
Endostatin won't be available for years, and the National Cancer Cooperative Group reports that 350 other new treatments are also awaiting FDA approval. Meanwhile, the American Cancer Society says 552,000 Americans will die of cancer this year alone.
Yet this kind of thing is the rule with the FDA, not the exception. Depending on which study you trust, it takes seven to ten years to get a new drug to market. Those years mean deaths. Sam Kazman of the Competitive Enterprise Institute has studied the FDA approval process and his conclusions are sobering. According to Kazman:
- 22,000 people died waiting for the FDA to approve streptokinase—a drug that dissolves clots in heart attack patients—and since approval has saved tens of thousands of lives.
- More than 8,000 lost their lives while the FDA reviewed misoprostol—a drug that reduces gastric ulcers in arthritis victims.
- A five-year delay in approving Septra—an anti-bacterial drug—cost 80,000 lives.
And there are others…
- A study by Arthur D. Little, Inc. determined that a three-year delay in introducing propranolol—the first beta-blocker, used to treat angina and hypertension—resulted in 30,000 deaths.
- 3,500 kidney cancer victims died during the three-and-a-half years it took to approve Interleukin 2.
- 150,000 heart patients were victimized by FDA delays in approving an emergency blood-clotting drug called TPA.
- Almost any doctor in the world will tell you that taking a baby aspirin or drinking a glass of red wine every day helps reduce the threat of heart attack. But for years the FDA imposed fines or imprisonment on aspirin makers or wineries who tried to tell you that.
The drug that caused the most deaths prior to FDA licensing was Elixir Sulfanilamide. It was poorly researched and ended up killing 107 people.
Now compare this worst-case example from before FDA licensing to just one case caused by "drug lag" under the FDA. Elixir Sulfanilamide killed 107 people while the "drug lag" for Interleukin 2 killed 3,500. This comparison is typical. And that isn't the end of it.