A popular tactic employed by drug makers in lawsuits concerning their products is to escape responsibility for adverse effects by pointing to the fact that the FDA approved the drug and so, the reasoning goes, it must be safe. The FDA, however, is a partner in this marriage, as evidenced by its actions.
Due to an extended public relations effort by major drug makers, most Americans believe that the drug approval process is rigorous and complex, involving studies of thousands of people over a period of many years. Yet Freedom found that the scientific studies required for FDA approval generally last only about five to six weeks and involve a few hundred people at most.
With many drugs, it is anticipated and hoped the consumer will take the substance for a lifetime. Thus the short term of these FDA studies would entirely miss such ghastly side effects as tardive dyskinesia and tardive dystonia3. In people suffering from these permanent conditions, the muscles of the face and body contort and spasm involuntarily, drawing the face into scowls and grimaces and often forcing the body into bizarre contortions.
A side effect such as sudden death could also easily escape detection in a short-term study, but even with a frequency of only one half of one percent, such a drug could kill 5,000 of the first million people that take it.
|The FDAs tolerance of false and misleading promotion of psychotropic drugs allows substances on the market that poison the body and can kill with little or no warning. According to FDA Deputy Commissioner Mary Pendergast (above), drug manufacturers spend more than $10 billion each year to hawk their wares.||The American Psychiatric Associations Task Force to Study the Impact of the Potential Loss of Pharmaceutical Support concluded decades ago that the APA would perish without these funds. Theres a new APA president, Herbert Sacks (above), but nothing new in terms of the groups funding source.|
Agency Reportedly Ignored Signs of Nerve and Brain Damage
And so it is that with an ocean of FDA-approved substances readily available, up to 180,000 people, according to medical writer Martin Zucker, are killed as a result of medical drug side effects each year, with hundreds of thousands more maimed through brain damage or other means.
Even diet pills have their hazards. In May 1997, several dozen neuroscientists wrote to the FDA, charging that it had ignored tests that showed extended use of the diet drug Redux could create nerve and brain damage.
Said Dr. Mark Molliver of the Johns Hopkins Medical School, Laboratories around the world have found that the drug has serious brain toxicity. It has the potential for producing brain damage.
Yet the FDA took no action. Still, someone at the agency must have been suspicious. When Redux was approved in 1996 as a diet pill, it required the manufacturer, Wyeth-Ayerst Laboratories, to conduct a follow-up study to determine ill effects users might be suffering a study on which critics said the company dragged its feet. As of the publication of this article, no follow-up had been done, even though sales of the drug soared up to $200 million per year. And despite evidence of potential dangers, the FDA approved Redux for extended use up to one year.
In 1996, the National Institutes of Health linked both Redux and fen-phen, a combination of two drugs widely taken by dieters fenfluramine (also made by Wyeth-Ayerst) and phentermine to short-term memory loss. Fenfluramine and phentermine were separately approved by the FDA, never as a combined treatment, as they came to be used.
Medical reports also connected fen-phen to lung problems and, by summer 1997, at least 24 deaths had been reported involving Redux or fen-phen but no action came from the FDA.
In early September 1997, after the death of the wife of the mayor of North Miami Beach was ascribed in part to fen-phen, the Florida Board of Medicine declared the combination constituted a public health threat and banned fen-phen for 90 days by emergency order. It was announced that board members would be studying the drugs effects and drafting rules regarding their use something the FDA should have stepped in to do long ago.
Shortly thereafter, on September 15, Wyeth-Ayerst withdrew fenfluramine and Redux from the market following reports that 92 out of 291 people taking the drugs 31.6 percent had developed abnormalities in the valves of their hearts which allowed blood in and out. It was yet another shocking announcement for the millions of Americans that had taken these drugs, believing them to be safe. An estimated 20.6 million prescriptions were written for Redux or fen-phen in 1996 alone.
No Sleep Lost
Likewise, when Stadol was approved by the FDA in 1992 as a headache remedy, it was not known that the substance would turn out to be addictive and, in some cases, deadly. Recent research by Dr. Morris Fisher, a Chicago neurologist, explored the drugs dangers, which reportedly include 34 possible deaths and 959 other adverse reactions. Fisher became interested in the drug after his 24-year-old son killed himself in 1995 while trying to withdraw from it.
The FDA gave a green light to a record 53 new drugs in 1996. Those are 53 potentially lethal substances which may result in tens of thousands of deaths, said William Moore, Atlanta attorney and FDA expert. Trouble is, it will be years until the tally comes in and by then, for those people affected and their loved ones, it will be too late. But it is hard to imagine anyone in the FDA losing sleep over this.
Taking the Gloves Off
Then there is the flip side of the FDA products which have been kept or taken off the shelves due to agency action. What emerged was a pattern of misguided priorities and even retaliatory tactics.
Case in point: At the direction of then-Commissioner Kessler, the FDA seized 24,000 gallons of Citrus Hill Fresh Choice orange juice because the label bore the word fresh in the brand name, when it was made from concentrate a fact the label also stated.
This bizarre incident wasnt in isolation. In 1995, the agency sent out more than 1,600 letters mostly to mom and pop health food stores and alternative medicine establishments warning the recipients they were in violation of one or more regulations, some highly obscure. Under Kesslers reign, the agency also staged numerous raids on vitamin stores and health food suppliers, some with drawn guns, seizing primrose oil, black currant oil and vitamin products.
Only about 10 percent of its warning letters went to pharmaceutical manufacturers chiding them for violations of advertising regulations. In September 1996, Public Citizens Health Research Group condemned these violations as the tip of a very dangerous iceberg and exhorted the FDA to use criminal prosecution to send the message that such violations are not acceptable. No such action appears to be forthcoming from the halls of the Food and Drug Administration.
While treating drug companies with kid gloves, the FDA crushes non-addictive remedies, such as L-tryptophan and other amino acids.
Amino acids are essential building blocks, manufactured by the body and obtained from certain foods. In 1989, the amino acid L-tryptophan was linked to adverse effects, including deaths. This became the agencys primary argument for moving against amino acids.
Studies published in The Journal of the American Medical Association and The New England Journal of Medicine demonstrated that the deaths were due to a contaminant in a single batch of L-tryptophan from a single foreign manufacturer and thus were not due to L-tryptophan at all. The FDA recalled L-tryptophan from the market in 1989 and, despite evidence that it is safe, has refused to allow it back on.
Neither the FDA nor the Centers for Disease Control in Atlanta have been able to document any health hazards associated with the use of nutritional products. The FDA does, however, have thousands of reports on file of drugs it has approved causing psychosis, violence, homicides, cancer, heart attacks and numerous other complications, even death. Its efforts to ban nutritional claims and make nutritional supplements available by prescription only seem suspiciously like a method of increasing public dependency on drugs by keeping the ingredients of good health out of reach.
For the general public and for the health food and nutritional supplement industries, its an ongoing battle, with the odds presently stacked in favor of the FDA and drug company interests. With $700 million in taxpayer dollars at his disposal each year, Kessler operated a campaign to protect the public from beneficial nutrients and health foods which led one observer to label the agency the Food Gestapo.
The FDA and the drug companies are two faces of the same coin, said attorney William Moore. The FDA will always protect the interests of the pharmaceutical industry because, to a large extent, the FDA is held captive by that industry. Typically, drug company executives have served a stint at the FDA. They know each other very well.
Preventing Future Tragedies
Because the FDA has been subverted by those most in need of its oversight, it has devolved into an agency unworthy of public trust. As a result of its actions and inactions, America is turning into a nation overwhelmed by and addicted to drugs, while billion-dollar profits pour into the pockets of those who so readily manufacture and supply them.
The reasons promoted for use of deadly biochemicals to alter moods, to escape from troubling situations in life, to live with problems at work or in marriage, to manage ones child are based on lies cleverly packaged to appear as scientific fact, using experts whose interests lie only in money, not results.
Those in positions of public trust and authority who should be holding up the Stop sign to the makers of these substances disposed of that warning long ago, along with their own integrity. And there may be no better example than the Food and Drug Administration of an agency charged with protecting the American people which has abandoned its public mandate.
To solicit or accept contributions from the firms one is supposed to monitor destroys independence. The implications of such aid are obvious and undermine whatever vestige of objectivity the FDA may claim to retain.
Similarly, the practice of trading personnel with the private sector accepting pharmaceutical employees as FDA staffers and letting them review the drugs in which their firms have such a large vested interest must cease, as must the custom of using individuals with personal interests in drugs pending review in any part of the approval process. In short, the agency needs a thorough fumigation to eliminate conflicts of interest that can only work against the health and welfare of the American people.
Street drugs now recognized as deadly, such as heroin, morphine and LSD, were launched into society as medical drugs. Today Ritalin, Prozac, Demerol, Dilaudid and others all approved by the FDA follow their path.
Such legal psychotropic drugs among them some of the most addictive substances on the market have been the subject of intense scrutiny by Freedom. Those who rubber-stamp the approval of these drugs are vital players in the psychiatric drugs-for-dollars industry. And they have steadfastly proven their inability to be objective when it comes to such substances while admitting ignorance of how addicts become addicted.
As an initial matter, such practitioners must be banished from the FDAs approval process, for here again lies conflict of interest; but, from a broader view, if the agency were to utilize genuine scientific criteria in the examination and approval of such drugs, none would ever arrive on the market at all.
When an FDA exists which plays its role straight and as intended, all Americans and indeed everyone in the much broader sphere will benefit. Driving or flying under the influence of mind-bending drugs would be as illegal as drunk driving, as well it should be. Tragedies such as those which claimed Princess Diana and Don Simpson will be far less common. And our children, and their children, will be less troubled by dealers pushing the most widely abused new street drugs Ritalin, Prozac and others on their playgrounds in the years to come.