Subject: Drug Test Loopholes

Date: Mon, 7 Oct 2002 09:08:50 -0400

The medical, legal and ethical repercussions of the use of untested medical products–including the smallpox vaccine– have not been publicly debated.

Below is a column by Meryl Nass, MD, that appeared online at Redflagsweekly.com in August, addressing the inadequate testing of drugs and vaccines–especially those developed and used by the Defense Department.

Whereas new drugs must be tested in humans for safety and efficacy before they can be licensed by the FDA, “scores of vaccines and other products have been developed at USAMRIID (the Army’s center for biological defense research) for instance, and received INDs, but human clinical trials required to support a license application were never performed.”

Essentially, what’s being confused is the difference between “research” and “unlicensed use in the absence of research” of investigational products. Dr. Nass noted that: “FDA has discovered that the burden of protecting the public health can be shifted from the agency, and onto the backs of doctors and patients, by using “creative” labeling.” That makes everyone an uninformed, human guinea pig.

* Dr. Nass is a member of the board of directors of AHRP.

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DRUG TEST LOOPHOLES More On The Inadequate Testing Of Drugs

By Meryl Nass, MD

One question that I believe needs a legal resolution is the difference between “research” and “unlicensed use in the absence of research” of investigational products.

FDA generally approves an investigational new drug application (IND) to permit drug developers to perform human studies of the drug. The intention is to gain evidence of safety and efficacy for eventual licensure.

Yet INDs have been employed by the Defense Department to permit routine use of untested drugs, without any intention of putting the drug through the rigorous experimental process required for licensure.

Scores of vaccines and other products have been developed at USAMRIID (the Army’s center for biological defense research) for instance, and received INDs, but human clinical trials required to support a license application were never performed. Some of these drugs and vaccines have been given to USAMRIID staff and to special operations troops for many years, although recipients were not always offered informed consent. [CDC 1960s anthrax vaccine trial data, obtained by the author via FOIA.]

Some were given to troops in the Gulf War. Although a waiver of informed consent was issued by FDA for use of only two unlicensed products in the Gulf theater, recent reports revealed that at least eight such products were used. The medical, legal and ethical repercussions of the use of the other six products have not been publicly discussed….

Full text at: http://www.redflagsweekly.com/nassdrugtest.html