An AP article last week announced the conclusions of a Federal Food and Drug Administration (FDA) sponsored study of American's restaurant eating habits. The FDA thinks restaurant owners should help the FDA improve our health by cutting portion size. Not satisfied with the hundreds of thousands of deaths every year from official meddling in the drug market, the FDA now wants to regulate the three basic food groups, pizza, burgers, and fries. Can rationing of beer, ice-cream, and chocolate be far behind?
In modern America do-gooders, busybodies and world improvers are everywhere leading the march to government control of every detail of our lives. In my own hometown the Key West City Commission offers a model of government for which nothing is too trivial or silly to remain unregulated.
The Commission has blessed an apparently grateful electorate with laws controlling such minutia as shrubbery species, house color, roof covering, and people who paint themselves silver. Such laws feed a growing swarm of enforcement pests while accomplishing little. In the end, however, they are only wasteful and silly.
The FDA, on the other hand, with control of our food and medicine, is much more dangerous than local busybodies ever will be.
The FDA's desire to make rules for burger weight and pizza diameter is a classic example of an agency rooting around like a truffle snuffing pig in the forest of our private affairs, looking for hidden nuggets of power. It would be justifiable if the FDA's work so far had any measurable benefit. Unfortunately, a look at the agency's record shows the opposite to be true. The FDA has caused much more harm than it has prevented.
It is a well-known axiom of bureaucratic butt covering that nobody gets in trouble for saying no. Following this imperative the FDA has created an approval process for new drugs that efficiently generates red tape, flawed science, and rich opportunities for collusion with the regulated. The process fails to generate drugs that are any safer than unapproved drugs available elsewhere in the world. The Tufts Center for Drug Development estimates it costs on average $800 million to bring a new drug to market in the U.S. The average time for approval is over 15 years.
Even when you spend almost a billion dollars getting official government approval, you can't know everything. An article in the New England Journal of Medicine stated, "Overall, 51% of approved drugs have serious side effects not detected prior to approval." Worse yet, with such hefty sums on the line, the further into the process a drug goes the more powerful are incentives to ignore any unpleasant side effects that are discovered.
More than one hundred thousand people die every year from adverse reactions to prescription drugs. That doesn't count the screw ups that kill people who receive the wrong drugs.
FDA approved drugs like Viaoxx, Trasylol, Zyprexa, Bextra, and heaven help us, Viagra, have cause thousands of deaths. Although Viagra patients who have nearly died generally agree that, "it was worth it."
At nearly a billion dollars a throw for approval, is safety too much to ask?
As bad as they are, however, unexpected side effects from approved drugs are not the biggest killer. The more impressive death toll is among those who cannot get lifesaving drugs while they are lost in the labyrinthine FDA approval process.
The FDA isn't just in the business of warning citizens about potential trouble and then letting them make their own decision. To avoid the risk that people would ignore the medical recommendations of bureaucrats, the sick are forbidden to seek unapproved treatment, even at their own risk. The FDA forces patients not only to risk death, but fines and imprisonment as well. Even the terminally ill may not make treatment decisions without FDA approval. As a consequence, thousands die waiting for drugs that are available and successful in other countries.
Here are two examples. There are many, many more. The first beta-blockers were used in
England in 1965. Between 1965 and 1976, when the FDA finally approved them, an estimated 10,000 Americans per year needlessly died of hypertension and angina. This delay alone could be responsible for more deaths than all the drug mishaps in this century combined.
For over 10 years the FDA has banned a simple device called The Sensor Pad, two sealed plastic sheets with a lubricant between. The pad reduces friction during a breast cancer exam making detection of small, early lumps much easier. The product is sold throughout Asia and Europe. The FDA wants the pad to undergo the same $800 million process it uses for drug approval. The item costs less then ten bucks. It is no more complex than a coolie cup. The number of women who died in the last 10 years because they missed a lump when it was small and harmless is impossible to know. But our protectors at the FDA can take the blame for at least a few of those deaths.
Additional sickness, death and heartache have resulted from FDA censoring of health information. The FDA has actively suppressed information on the health benefits of vitamin C, aspirin, folic acid (which prevents the horrific birth defect known as spina bifida), calcium, and the herbal no-calorie sweetener, stevia. The FDA demanded that a U.S. company destroy cook books featuring stevia recipes. Do we want an agency that sponsors book burnings to control the junk food supply?
One simple change in the law would save many lives. We should make the drug and medical treatment market as free as the junk food market. Let patients and doctors decide what drugs and treatments are best for them. If FDA approval were simply one more piece of information in deciding medical treatment, rather than a shotgun wedding to Typhoid Mary, lives would be saved.
