Death by Regulation

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

FDA’s Myth of Consumer Protection

The public has been deceived into believing that government “regulations” protect consumers against dangerous and ineffective products. The media, the government, academia, and even large drug companies perpetuate this myth.

For those who believe that government regulations provide a benefit, one only has to look at the cost and dangers of heavily regulated drugs and compare them to those of deregulated dietary supplements.

In 1994, Congress weakened the FDA’s authority to regulate dietary supplements. Critics predicted that this would expose Americans to all kinds of dangerous and bogus products because the FDA would not be able to “protect” the consumer. Since 1994, whenever a hint of concern arises about a dietary supplement, the media and FDA blame the fact that natural products are not “regulated” and therefore pose inherent dangers.

When looking past the FDA and media’s charade about the need for regulation, an interesting pattern of truth emerges. After dietary supplements were deregulated, prices plummeted, more effective nutrients became available, and, most important, virtually no side effects occurred despite the government not overseeing content or potency.22,23

Compare what has happened with deregulated dietary supplements to heavily regulated prescription drugs. Since 1994, drug prices have spiraled so far out of control that the nation’s health care system is facing insolvency; overpriced new drugs are often no better than older drugs; no major disease has been cured; and a record-breaking number of adverse drug reactions and deaths have occurred.24-27

Those who believe they need FDA regulations to protect them are ignoring historical reality. Regulations are the underlying cause of dangerous drugs, ineffective drugs, and overpriced drugs. Regulations enable incompetent FDA officials to declare a drug “safe.” Regulations enable drug companies to exaggerate the purported benefits of drugs approved by the FDA. Regulations protect drug companies against lower-cost competition.28

The most devastating effect of regulations is that they suffocate medical innovation. The FDA has made it so complicated and expensive to get a drug approved that drug companies spend inordinate amounts of their resources just bringing out different versions of existing drugs, instead of investing in novel technologies needed to find cures for the killer diseases of aging. Getting another “statin” drug approved is easy compared to getting the FDA to understand how a new therapy might work by an unprecedented mechanism. Small companies that have innovative ideas but not a lot of money stand little chance of getting their products to market.

The Free Market Solution

The FDA pretends that its regulations protect Americans, yet studies published in establishment medical journals document that regulated drugs are a leading cause of death in the US.30,31

Table 1 shows the astounding price decreases of dietary supplements after their deregulation. We state unequivocally that if Congress took the bold initiative of deregulating prescription drugs, their costs would fall even more dramatically than did the costs of dietary supplements.

The reason is that it costs more to extract nutrients from plants and to synthesize vitamins and amino acids than it does to make most synthetic drugs. In a deregulated environment, prescription drug prices would drop to such low levels that cost would no longer be an issue.

As you can see in Table 2, the cost of the active ingredients in prescription drugs is so low that anyone could afford them in a deregulated environment.

Cynics say drug companies need this money to develop better drugs. This argument rings hollow when one realizes that the costs of even FDA-regulated generic drugs are excessive.

The facts are that regulation and artificially high prices have created an environment in which innovation is a distant second to marketing, political lobbying, campaign contributions, bloated administrative budgets, etc. If prescription drugs had to compete in a deregulated free market, companies would be forced to develop better products because the FDA would not be delaying competing products for years or decades at it does now.

In a free market, the better-quality, lower-priced products rise to the top while inferior and overpriced products sink into oblivion. In today’s upside-down regulatory environment, less effective but heavily marketed drugs outsell superior medications.32,33

Large pharmaceutical companies have grown accustomed to multibillion-dollar blockbuster drugs that have 17-20 years of patent protection. Enormous resources are devoted to marketing these drugs. Even when the patent expires, drug companies often allocate considerable financial resources to litigating against potential generic competitors, paying generic companies not to compete, and taking other steps to delay generic competition. None of these shenanigans could occur in a deregulated market where any company could compete on a level playing field.

Defending the Free Market

In the late 1980s, Life Extension led the charge that blocked the FDA from gaining totalitarian powers under the guise of needing to “protect” the public against “dangerous vitamin supplements.” We then turned this anti-FDA momentum into an onslaught of letter writing to Congress that resulted in the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994.

DSHEA may be coming under siege, as increasing numbers of Americans are switching to safe, low-cost dietary supplements in lieu of side effect-prone, expensive prescription drugs.

The cover of the November 29, 2004, issue of Forbes magazine was titled “Pharma’s New Enemy: Clean Living.” The cover graphic shows a hand dropping prescription drug pills into the garbage can, with the subtitle, “Throw Out Your Prozac®, Your Nexium®, and Your Ambien®.”

The Forbes article described natural lifestyle changes that have enabled people to reduce or eliminate prescription drugs. The article also quoted mainstream doctors saying that Americans are overmedicating with side effect-prone drugs whose benefits are exaggerated by the drug companies.

Clearly, drug companies have an emerging new competitor: sellers of dietary supplements. There appears to be a concerted effort to discredit the safety and value of dietary supplements. The media is fed blatantly false and misleading reports about supplements, and then turns these stories into headline news because so many Americans now take vitamins.34,35 Congressional investigations have revealed how drug companies spend enormous amounts of money to persuade the media to publish stories that are favorable to their industry.36

Shortly after Merck withdrew Vioxx® from the market, the media disseminated a negative report about vitamin E that contained so many omissions that its conclusions had no basis in fact.37-38

The Life Extension Foundation analyzed every statement in this negative report, and we are including a thorough and meticulous rebuttal in this issue of Life Extension. In this instance, the media was duped into facilitating a massive deception against aging people who are in critical need of antioxidants to stave off degenerative diseases.

For longer life,

William Faloon