Death by RegulationMarch 2005
By William Faloon
Consumers are being defrauded out of their health and money by a regulatory system that is a proven failure.
Back in the early 1980s, the Life Extension Foundation provided compelling evidence that FDA-approved drugs were dangerous and overpriced. We also gave examples of lifesaving medications that the FDA delayed, resulting in the needless deaths of millions of Americans.
We warned of a health care cost crisis if Congress did not abolish the FDA or markedly diminish the agency’s powers. We even went so far as to establish the FDA Museum to specifically document how flawed government regulatory policies were the leading cause of death in the US.
Sadly, most of the reforms we sought did not pass Congress. The result is that health care has become so expensive that record numbers of Americans are without medical insurance.1,2 Those who have insurance are paying outlandishly high premiums and deductibles. Medicare faces insolvency, FDA-approved drugs are killing record numbers of Americans,3 and medical innovation is stifled by over-regulation.
One solution discussed on Capitol Hill is to create still another bureaucracy to oversee the FDA. The reason for creating a separate agency is that it has become clear that the FDA is unable to protect Americans against unsafe drugs.
A growing number of influential Americans are alarmed at the FDA’s cozy relationship with big drug companies. Those involved in alternative medicine have long argued that the FDA functions to protect the financial interests of large drug companies and not the American public. This allegation was confirmed when the FDA launched an all-out campaign against the right of Americans to purchase lower-cost medications from other countries.4
To protect the outrageous profits of drug companies against lower-cost imports, the FDA went so far as to commit perjury before Congress, disseminate knowingly false propaganda to the public, and engage in illegal lobbying activities. Life Extension revealed these immoral and illegal acts years ago.5-7
FDA Comes Under Growing Criticism
Because of the Vioxx® scandal, the FDA has come under harsh criticism by members of Congress, the medical establishment, and even one of its own high-ranking officials.8,9
In testimony before Congress, Dr. David Graham, a 20-year FDA scientist, estimated that Vioxx® had caused 88,000 to 139,000 excess cases of heart attack and stroke. Criticizing the very agency he works for, Dr. Graham stated:
“I would argue the FDA as currently configured is incapable of protecting America against another Vioxx®. We are virtually defenseless.”10
Dr. Graham said that he felt pressured by supervisors at the FDA to water down his findings showing that Vioxx® increased heart attack risk. If this sounds like a familiar pattern of improper behavior, it is because you read about this very same problem in an article I wrote one year ago—before Vioxx® was withdrawn from the market!11
After Dr. Graham testified about the FDA’s shortcomings, seven other FDA-employed scientists wrote to a Senate committee vouching for Dr. Graham’s “unquestioned integrity.”12
PBS Exposes FDA Failings
On November 17, 2003, the PBS documentary “Frontline” aired a shocking exposé about dangerous prescription drugs and the FDA’s complicity.14
The “Frontline” producers initially investigated drugs that had been withdrawn from the market because of adverse side effects. After filming began, however, current and former FDA employees started coming forward to offer a powerful critique of what was really going on inside the agency. As the story evolved, instead of 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” discovered, the FDA does not conduct clinical trials, but instead reviews the results submitted by pharmaceutical companies. This means that the basis for FDA approval of a drug is often “safety data” provided by the very company that makes the drug!
“Frontline” interviewed current and former FDA employees who revealed instances in which drug dangers were clearly present but were ignored or covered up by higher-level FDA officials. Only after numerous injuries and deaths were these drugs withdrawn or relabeled. A survey of all FDA employees showed a significant number felt that they were pressured by others in the agency to give favorable reviews to dangerous and ineffective drugs.
PBS exposed this outrageous conduct before the Vioxx® scandal broke, yet it took tens of thousands of additional deaths before Congress held any hearings. “Frontline” confirmed that the FDA’s drug-approval process is a sham—something Life Extension had revealed 20 years earlier.15