Nutraceuticals and nootropics for anti-aging

Navy condemns FDA for obstructing vital medical research

The U.S. Food and Drug Administration has many critics, but none are more angry than those who have lost loved ones — or who are about to lose their own lives — because the FDA has blocked their access to life-saving treatments. Now these critics have a new and unexpected ally: the United States Navy.¹

For the past four years the U.S. Navy has been trying to gain FDA approval for a clinical trial of a blood substitute being developed by Biopure Corporation. The blood substitute, “Hemopure”, is a fluid containing cell-free hemoglobin extracted from bovine red blood cells, and salts like those found in blood.⁷

The FDA has refused to allow these clinical trials, citing safety concerns. Meanwhile, for lack of useable blood or blood substitute, countless people have died before reaching hospitals.²

The situation is similar to that faced by millions of people with terminal diseases who are unable to obtain potentially life-saving treatments because of FDA nit-picking over clinical data. This agency would prefer to have a hundred thousand people die from not having access to a new treatment than to risk having a hundred people die from potential side effects. Why? Because when a hundred people die from side effects, it makes the news and the FDA gets criticized. When a hundred thousand people die from drug unavailability, nobody pays any attention.

During the first decade or so of the AIDS epidemic, tens of thousands of AIDS patients died unnecessarily because of FDA foot-dragging and screwy priorities. The situation hasn’t really improved much since then, judging by this latest flap over blood substitutes.^3,4

The situation for nutritional supplements is not quite as bad as it is for drugs and other medical treatments — thanks to the Dietary Supplement Health and Education Act of 1994, which has largely protected supplement users from the kind of totalitarian action which the FDA directs at the medical world.⁵ However, the FDA and its counterparts in other countries have had a basic antipathy toward vitamins and other dietary supplements, and we would all be better off if the next FDA commissioner is someone with a libertarian viewpoint rather than a totalitarian one.⁶

References

[1]  Regulatory Affairs: GEN's Spotlight on the FDA Genetic Engineering and Biotechnology News, 29:10; May 15 2009

[2]  Navy rips FDA for blocking clinical trial The Boston Globe, 2009 April 4

[3]  Importing AIDS Drugs: Analysis of F.D.A. Policy New York Times, 1988 July 26

[4]  Deadly delay in AIDS research roadblocks in the way of a remedy San Francisco Chronicle, 1989 January 30

[5]  Dietary Supplements: Background Information National Institutes of Health website, 2003 June 22

[6]  Tough Challenges at the FDA American Enterprise Institute for Public Policy research, 2009 Jan 21

[7]  Biopure's Oxygenation Technology Biopure Corp. website, 2008 January