Guinea Pigs

The New York Post has, quite rightly, been raising a fuss over the disclosure that patients in the state health system are being dosed with experimental drugs. The Post has been breaking hair-raising stories about experiments inside the state medical system which have killed at least one patient, Joseph Santana, last October 13. A German drug company, Hoechst Marion Roussel was paying the state of New York to experiment on people like the late Santana, dosing him with experimental drug M 100907, Olanzapine and Ativan. The Post disclosed a draft report of the state Dept. of Health saying 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 were awash with drugs, sanctioned by the FDA, 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 formulated by I.G. Farben, makers of Zyklon B. According to Freedom, a useful magazine published by the Scientologists, 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. Ironically, methadone centers in New York have come under well-merited assault from our own local Nazi, Rudy Giuliani. Shrinks and health workers like it because it reduces the addict/patient to a compliant slave, which is 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 potentially 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. Lilly credits three researchers Bryan Molloy, Ray Fuller, David Wong with key roles in discovering it. In the early 70s Molloy was looking for compounds resembling antihistamines that might function as antidepressants. Fuller suggested a concentration on compounds that would influence the level of serotonin in the brain. Wong developed a method of measuring serotonin levels in the brain cells of rats. They and their colleagues came up with a psychoactive compound they christened fluoxetine hydrochloride, which was then given the trade name Prozac.

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. A New Drug Application was filed in September 1983, seeking approval for marketing Prozac to the general public for treatment of major depression. That approval was granted Dec. 29, 1987, despite the fact that some serious red flags had been raised when the FDA examined the results of the clinical trials Lilly had conducted (i.e., paid for with grants to investigators at various universities and private research institutions).

The clinical trials of Prozac excluded suicidal patients, children and elderly adults although once FDA approval is granted, the drug can be prescribed for anyone of any age. Some 4000 people were involved in various pre-marketing studies, but only 1730 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 for a period of more than two years, nobody knows what the long-term effects are. Some physicians foresee a range of problems developing in years to come including dependency (as indicated by tolerance build-up and withdrawal symptoms upon cessation), damage to the liver, early onset of Alzheimers, etc.

Prozac was granted FDA approval on the basis of three studies indicating that it relieved some symptoms of depression more effectively than a placebo, and in the face of nine studies indicating no positive effect. According to FDA regulations, a drug need not prove effective in a majority of its clinical trials in order to gain approval, it need only show statistical superiority over placebos in two such trials and Lilly eventually came up with three such studies. The FDA did not require Lilly to indicate on its label that Prozac is a stimulant drug or that it can cause or worsen depression.

Prozacs great selling point, from the perspective of those writing the prescriptions, was its safety compared to other kinds of antidepressants. According to David Dunner, MD, director of the University of Washingtons Center for Anxiety and Depression, Prozac became popular not because it works better than other drugs. Indeed all antidepressant drugs seem to work well in about 70% of patients. Fluoxetine has a much more benign side-effect profile than previously used drugs.

Unlike the tricyclics (Elavil, Pamelor, etc.), which have strong cardiac effects, selective serotonin re-uptake inhibitors cannot cause death by overdose. Unlike the monoamine oxidase inhibitors (Nardil, Parnate, etc.), they do not lead to dangerous interactions with common foods such as cheese and nuts. From the physicians point of view, Prozac eliminated the Catch-22 involved in prescribing a potentially lethal dose of a drug to a potentially suicidal patient. Sales took off immediately.

These days Prozac is an integral part of the vast depression industry whose proud statistic, offered by the National Institute for Mental Health, is that around 17 million Americans suffer from depression. Just as methadone is the ideal drug with which to service officially recognized drug addicts (methadone has a half-life in the body of much greater duration than heroin), so Prozac and cognate proprietary medications service the depression industry run by the half-million Americans who work in psychiatric facilities, including nearly 40,000 psychiatrists, some 80,000 clinical social workers and 40,000 clinical psychologists. Throw in nearly 50,000 family counselors and you get some notion of the caring legions empowered to tell us that our problems stem from clinical depression, rather than insecurity and stress consequent upon screwed-up economic and social priorities that see many earning less than they did 20 years ago, though they work much harder. Back at the start of this in 1994 Dr. Fred Goodwin of NIMH was integral to the promotion of Americas new Great Depression, launched with tremendous hoopla in the form of a study purporting to show that the cost of depression to America is just under $44 billion a year. A cascade of bogus statistics followed this bald calculation, including a grotesque estimate that Americas 19,400 suicides in 1990 cost Uncle Sam $7.5 billion in lost productivity and that 60 percent of the self-slaughterers did so because of depression. And the other 40 percent?

The study was put together by people from the Sloan School of Management at MIT, a private outfit called the Analysis Group and someone from the National Bureau of Economic Research. Along with Dr. Goodwin, Tipper Gore, at that time the White Houses anchor on mental health, promptly hailed the report as indicative of the vital necessity for a huge boost in the nations health spending in this area.

Almost all newspaper, radio and tv accounts failed to mention that the report and the press conference promoting it were backed by Eli Lilly, the pharmaceutical company that makes Prozac (and that, incidentally, also concocted LSD), now being promoted as the cure for the Second Great Depression. Goodwin's NIMH and Lilly worked together in the recent national tv campaign on depression. The NIMH claims that no fewer than 52 million American adults a fifth of the population have a diagnosable mental illness. 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 okay. 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 small pox strains at Washington National Airport and the downtown bus station.

In this particular operation agents from the Army's chemical special OPS 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 l984 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 was 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.

Thirty-one years ago I narrowly missed being killed in another type of experiment, this time probably conducted by the British Ministry of Defense. The case is now being revived in the Irish newspapers, because the Irish government is pressing for disclosures. On March 24, 1968, Flight 712, run by the government airline Aer Lingus, took off from Cork Airport, bound for London. A few minutes later the plane, named the St. Phelim, a Vickers viscount, began to lose altitude. Paul Heffernan, the co-pilot, radioed 12,000 feet, descending, spinning rapidly. The captain, Barney O'Beirne, managed to level the four-engine plane about 1000 feet above the water and it flew thus for 15 minutes before crashing close to Tuskar Rock.

The prevailing view is that the St. Phelim was hit by a rogue missile from the British Royal Aircraft Establishment range at Aberporth in Wales. Another view is that a British warship in the area mistook the St. Phelim for a pilotless drone. The British navy tried to raise the wreckage of the St. Phelim without using a steel net and succeeded only in scattering it more widely on the ocean bed. On Jan. 12 of this year Mary O'Rourke, Ireland's enterprise minister, reopened the case in a formal meeting in Dublin with the outgoing British ambassador, Dame Veronica Sutherland.