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.
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.
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.
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.
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. 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
Regulatory Affairs: GEN's Spotlight on the FDA
Genetic Engineering and Biotechnology News, 29:10; May 15 2009
Navy rips FDA for blocking clinical trial
The Boston Globe, 2009 April 4
Importing AIDS Drugs: Analysis of F.D.A. Policy
New York Times, 1988 July 26
Deadly delay in AIDS research roadblocks in the way of a remedy
San Francisco Chronicle, 1989 January 30
Dietary Supplements: Background Information
National Institutes of Health website, 2003 June 22
Tough Challenges at the FDA
American Enterprise Institute for Public Policy research, 2009 Jan 21
Biopure's Oxygenation Technology
Biopure Corp. website, 2008 January