The FDA's Guinea Pigs

by Alexander Cockburn

A German drug company, Hoechst Marion Roussel, was paying the state of New York to experiment on people like the late Santana. He was dosed with an experimental drug, M 100907, Olanzapine and Ativan. The Post disclosed a draft report of the state department of health that said the state should be allowed to engage in "slightly risky experimentation on mentally ill adults -- even if the patients are unable to grant or deny consent." Rising in strenuous denunciation of this disgusting policy on Jan. 19, the Post marshaled Immanuel Kant: "Every man is his own sovereign and cannot be exploited for the use or benefit of another."

The problem is that we're awash with drugs, sanctioned by the Food and Drug Administration, which are ongoing "experiments" carrying great risks and costs. Take methadone, originally formulated in Nazi Germany and initially named "Dolophine" in honor of Adolf Hitler. Dolophine had been developed by I.G. Farben, makers of Zyklon B. Ervin Kleiderer, a research chemist from the U.S. pharmaceutical firm Eli Lilly, led a research team to Hoechst am Main in 1945 to examine the I.G. Farben plant. Kleiderer brought back the mix for Dolophine, initially sold by Lilly as a cough medicine, retaining the old Nazi name.

The drug was removed from the market but later made its big comeback as methadone, a viciously addictive drug that is given to heroin users and captures them even more effectively. Methadone centers in New York have come under well-merited assault from Mayor Rudy Giuliani. Shrinks and "health workers" like methadone because it reduces the addict/patient to a compliant slave, a condition the health bureaucrats esteem.

Prozac is another ongoing experiment. Tricyclic antidepressants -- not heroin or cocaine -- had been the leading cause of emergency-room overdose deaths in the mid-1980s. With the introduction of Prozac, physicians could prescribe an antidepressant without providing potentially suicidal people with a possibly fatal bottle of pills. Prozac was developed by scientists who posited that depression is the result of low levels of a chemical messenger in the brain called serotonin.

The FDA granted Lilly "investigational new drug" status for Prozac in March 1976, and over the course of the next 10 years, the company spent an estimated $80 million underwriting clinical trials, first on animals, then on people.

The clinical trials of Prozac excluded suicidal patients, children and elderly adults -- although once FDA approval is granted, a drug can be prescribed for anyone. Some 4,000 people were involved in various premarketing studies, but only 1,730 were in placebo-controlled trials. The approval of Prozac was based, ultimately, on fewer than 300 patients who met various criteria established by Lilly and the FDA.

Because only 63 patients were on fluoxetine (the psychoactive compound given the trade name Prozac) for a period of more than two years, nobody knows what the long-term effects are. Some physicians have foreseen a range of problems developing in years to come -- including dependency (as indicated by tolerance buildup and withdrawal symptoms upon cessation), damage to the liver, early onset of Alzheimer's and so on.

There isn't a day or night when corporate or government researchers aren't pressing ahead with tests and experiments risky to the health of the populace. The essential role of the FDA and kindred bodies is somehow to persuade us that everything is OK. The heyday for the experimenters came in the early Cold War years when the citizenry inhaled everything from strontium 90 to bacteria sprayed in subways and bus stations by the U.S. Army Chemical Corps, trying to figure out what would happen if the Russians introduced smallpox strains at Washington National Airport and the downtown bus station.

In this particular operation, agents from the Army's chemical special operations division carried dummy suitcases into a terminal at National and into the downtown Greyhound bus terminal. The suitcases had concealed sprayers that released millions of bacillus subtilis bacteria.

In the words of a press report in 1984 relaying the Army's admission that it had conducted such experiments 20 years earlier, "An analysis of test results concluded doses of microbes inhaled by passengers were 'large and of acceptable uniformity' enough to cause infection had smallpox virus been used instead of the bacteria." It turned out that the bacteria, which were supposed to be harmless, actually caused food and blood poisoning, plus respiratory problems. In kindred experiments, the Army prompted measles epidemics in a couple of communities in Florida and Georgia.

Often enough, one runs across experiments in which many or all of the victims turn out to have been black, as they were at Tuskegee. One 1975 experiment done on 34 people, 33 of whom were black, consisted of giving alcoholics anal injections of paraldehyde. At least two died from the injections, some tried suicide, and others became violent. None was a willing participant. A doctor took temperatures of the dying. There were no autopsies.