Life Extension Magazine March 2004
By William Faloon
The FDA claims that the drugs it approves are “safe.” This charade is rapidly collapsing. PBS television’s investigative series Frontline has aired a shocking exposé of dangerous prescription drugs and the FDA’s complicity in allowing this outrage to occur.1
The Frontline producers initially investigated drugs that had been withdrawn from the market. After filming began, current and former FDA employees started coming forward to give a powerful critique of what really goes on inside the agency. As the story evolved, rather than making a documentary about drug safety, Frontline ended up shifting its focus to the FDA itself.
A major emphasis of the documentary was the FDA’s reliance on drug companies’ research of their own products to determine safety. As Frontline found out, the FDA does not conduct clinical trials, because the agency is not in the business of conducting medical research. The FDA instead reviews the results submitted by pharmaceutical companies. This means that the basis for FDA approval of a new drug is often “safety data” provided by the very company that makes the drug!
Frontline exposed this questionable drug approval sham to the world in a one-hour broadcast aired November 17, 2003. It was FDA drug reviewers who made the most appalling disclosures. These current and former FDA employees revealed incidences in which drug dangers were clearly present but were ignored or covered up by higher-level FDA officials. Only after many injuries and deaths were these drugs withdrawn or relabeled. A survey of all FDA employees showed a significant number felt they were pressured by others in the agency to give favorable reviews to dangerous and ineffective drugs.
The most absurd part of this saga is the FDA’s historical record of attempting to restrict consumers’ access to dietary supplements. The FDA deceitfully implies that supplements have hidden dangers. Yet the data supporting the safety and efficacy of nutrients usually come from independent sources, as opposed to the company-sponsored studies the FDA relies on to certify drug safety.
Frontline showed that in too many cases, the safety data supplied by drug companies are flawed and altered, with the result being an alarming number of injuries and deaths from prescription drug toxicities. Deaths from adverse drug reactions have become so commonplace that they rarely make the news.
For the past 18 years, Life Extension has harshly criticized this corrupt system of drug approval. What Life Extension lacked was the “inside” data gathered by Frontline that show specifically how the FDA conspires with the drug industry to approve dangerous drugs. Even more disturbing are instances in which the FDA allows toxic drugs to remain on the market even after injuries and deaths are reported. If the FDA had even a vestige of credibility remaining about its role of “protecting” the public against dangerous drugs, this Frontline documentary tore it to shreds. The emperor (the FDA) clearly has no clothes (credibility).
Drugs Often Do Not Work
Dr. Allen Roses is worldwide vice-president of genetics at GlaxoSmithKline. He is a world-class pioneer in the branch of medicine that studies the relationship between our genes and our response to individual drugs. On December 8, 2003, a British newspaper quoted Dr. Roses telling a scientific conference in London:
“The vast majority of drugs only work in 30 or 50% of the people.”2
Dr. Roses predicted that in a few years, scientists would be able to give patients a simple genetics test that would predict which medicines would work for them. Drug companies could use the information to tailor new drugs aimed at the 50% of people not helped.
It is an open secret within the pharmaceutical industry that most of its products are ineffective in most patients, but this is the first time that such a senior drug boss has gone public. Dr. Roses’ admission corroborates what FDA reviewers told Frontline—not only are many dangerous drugs wrongfully approved, but they often are only minimally effective!
Consumers Partially Prevail Against Codex
The European Union is aggressively seeking to set maximum upper-limit potencies for vitamin-mineral supplements, even though supplements used by citizens in its member countries have not demonstrated a health risk.
The Codex Alimentarius Commission (Codex) was established to review and evaluate nutrients to determine what potencies are “safe” for human ingestion. The objective is to “harmonize” these maximum upper-limit potencies to guard consumers around the world against the purported risks of vitamins.
After years of deliberations, Codex was on the verge of adopting the Recommended Dietary Allowance (RDA) as the maximum potency allowable in dietary supplements. This would have resulted in nutrient products so low in potency that the consumer would obtain virtually no benefit. For instance, the upper safe limit for vitamin B6 could have been as low as 2 milligrams, which would not provide the positive effects that have been documented in the published scientific literature.