Ain't Nobody's Business If You Do



Unless we put medical freedom
into the Constitution,
the time will come
when medicine will organize itself
into an undercover dictatorship.
a signer of the
Declaration of Independence
HOW CAN SOMETHING start out so good and become so bad? That's the question I ask myself each time I think about the Food and Drug Administration (FDA). It began as a good idea, designed to educate and protect the citizens of the United States. Now it regularly raids alternative healers, keeps healing and rejuvenative drugs away from those who might benefit from them, dictates what is and is not proper healing, and wants to severely limit our ability to buy vitamins, minerals, and other nutritional supplements. The FDA has, like Dr. Frankenstein's experiment, gone awry.
In the early 1900s, prepared foods and packaged medicines were a mess. As Upton Sinclair described in The Jungle, his 1906 expos of the meatpacking industry, meatpackers would pack anything into skins—sawdust, rat droppings, the digestive tracts of animals and all that they contained—and sell it as "pure beef sausage." One could never be sure if a quart of beef stew contained an entire quart of beef stew—or even if it contained beef. Over-the-counter "patent" medicines did not list ingredients or strength of concentration on the label. Or they might claim to contain medicines and be nothing but sugar-water in an imposing bottle.
Normally, it would be left to the states to regulate food and drugs through local health codes, honest-weight restrictions, and other regulatory laws. With improvements in packaging, transportation, and marketing, however, by the turn of the century many products were traveling across state lines. This brought them under the jurisdiction of the federal government: regulation of interstate commerce was one of the powers enumerated to Congress.

Sailing round the world
in a dirty gondola
Oh, to be back in the land
of Coca-Cola!
In 1906, Congress passed the Pure Food and Drug Act, which established that foods and drugs should be "unadulterated," and that their contents be clearly labeled. This was a much-needed regulation. The act, however, had this little loophole: What is "adulterated" and who decides what is adulterated?
Ironically, according to the book, The Big Drink: The Story of Coca-Cola by E. J. Kahn, Coca-Cola was taken to court by the government for marketing a "mislabled" product. In 1903, Coca-Cola had replaced "the real thing," cocaine, with caffeine (it was cheaper). Coca-Cola was in trouble not because it contained cocaine, but because it didn't. The case continued in court for nine years, and Coca-Cola eventually agreed to make changes in its manufacturing process and to list its ingredients—which included neither coca nor kola.
In 1927, the enforcement of the law moved from the Bureau of Chemistry (a division of the Department of Agriculture) into its own bureaucratic structure: the Food, Drug, and Insecticide Administration—a formidable, respectable name if there ever was one. Not surprisingly, in 1931 it dropped the Insecticide from its title and became the Food and Drug Administration.
The FDA was then given the power to ban "harmful" additives. By what criteria do we define "harmful"? If a chemical has a known lethal dose, should it be prohibited? If that were the case, salt could never be used as an additive. For the most part, whatever the FDA decided was harmful was harmful. The decisions were (and are) capricious at best.

Despite the belief
that handwashing is the most
important measure to prevent
the spread of infection in hospitals,
less than one third of physicians
wash their hands between patients.
Over time, the FDA also grew to encompass regulation over all medical techniques, practices, and devices. The original Pure Food and Drug Act (also known as the "Wiley Act") only required that food not be "adulterated" or "misbranded" when shipped across state lines. In 1912, the act was amended to prohibit false therapeutic claims. The problem with that is the same as determining what is "harmful": Who is to say what is and is not therapeutic?
For example, the placebo effect is a scientifically proven fact: if people take an absolutely worthless substance and believe it's going to make them better, it tends to make about a third of the people better. Bona fide, licensed, reputable physicians use placebos every day—with the approval of both the Food and Drug Administration and the American Medical Association. The doctor will charge the full amount for an office visit, write a prescription, send the patient to a pharmacy to pay a large amount of money for sugar pills. And insurance companies knowingly and willingly pay the bills. Whether it's belief in the doctor, in the pills, in getting out of the house and paying some money, or a combination of all those factors, one thing is certain: many people who take the sugar pills get better faster than people who are told by the doctor, "There's nothing I can do about this; it will have to run its course."
And so it was with the patent medicines. If advertising copy (and patent medicines were the largest advertisers in the country at the turn of the century) could convince you that Mother's Soothing Syrup would cure your cold, for a certain number of people, the cold got cured sooner than it would absent Mother's Soothing Syrup. If the medicine didn't work, the most the government could do was require that the manufacturer issue a refund.

the rule of no one
has become
the modern form
of despotism.
The 1912 law put the burden of proof on the government: a manufacturer had to be clearly defrauding the public. This was not stringent enough, however, and in 1938 the federal Food, Drug, and Cosmetic Act was passed. Since then it has been up to the manufacturer to prove—scientifically—that its drugs are effective. Good-bye placebo effect. (For patent medicines, at least. For the AMA and "legitimate" pharmaceutical companies—fine!)
While the spirit behind strengthening the FDA was certainly a good one, the results have been anything but. Yes, we can buy foods relatively free of rat droppings (FDA guidelines restrict the amount of animal droppings and insect parts permitted in foods, but do not prohibit them altogether), and while it's good to know that hemorrhoid cream has actually shrunk a "hemorrhoidal tissue" here or there, much of the FDA's current activity amounts to dictating what does and does not heal people and prohibiting the latter.
Just as people should have the freedom to find and worship God as they choose, so too should they have the freedom to maintain and enhance their own health as they choose.
The FDA neither believes nor supports this contention. Only medicine as the FDA and the AMA (it's hard to tell them apart most of the time) define medicine is medicine. Everything else is quackery. Quackery, according to the FDA, is not just misguided medical practices that American consumers need to be educated about; quackery is fundamentally evil, and those who traffic in it—both suppliers and consumers—must be punished.

Taking vitamin E supplements daily
for at least two years
appears to dramatically reduce the risk
of heart disease.
Separate studies of men and women
who took daily vitamin E supplements
had about a 40 percent lower risk
of heart disease.
May 1993
In some cases, the quackery of yesteryear is the sound medical practice of today; the sound medical practice of yesteryear is utter foolishness today.
George Washington, for example, was literally bled to death. It was the medical belief in Washington's day that, when ill, "pressure" had to be relieved and the "evil humors" had to be bled away. There's hardly a practice or procedure that was considered sound medical science 200 years ago that someone wouldn't be arrested for attempting today—and with good reason. As Thurman Arnold observed,

The principles of Washington's farewell address are still sources of wisdom when cures for social ills are sought. The methods of Washington's physicians, however, are no longer studied.

Conversely, to suggest fifty years ago that diet, exercise, or vitamins would help prevent or cure heart disease would have been considered blatant quackery. According to medical doctors, bed rest was needed if you had a weak heart, and lots of red meat. People were arrested for suggesting that exercise, reduced meat diets, and vitamin supplements would help the heart. Now these techniques are part of standard medical practice.
All this restriction came about because the FDA took a leap that defies logic. This from the official FDA history:

It was recognized that no drug is truly safe unless it is also effective, and effectiveness was required to be established before marketing—one of the major advances of medical history.

How can one equate safety with effectiveness? A safe drug is one I can put in my body and know that, as long as I take it in recommended doses, will not cause me to shrivel up and die. An effective drug is something else again. Yes, if one takes an ineffective drug when one could, instead, be taking an effective drug, the illness may become worse, and this is not good. To say, however, that the ineffective drug is not safe is confusing the issue and torturing the language. Saying a drug cures something that it does not makes the manufacturer guilty of false advertising, not of marketing unsafe substances.

The Puritan
through Life's sweet garden goes
To pluck the thorn
and cast away the rose.
The most the government should be able to do is warn the consumer of the potential risks—which include the risk that the drug or medical procedure may not be effective at all. Instead of giving certain products the "FDA seal of approval," the FDA wants to remove all products that it has not approved. The FDA also wants to arrest those products' manufacturers. I shouldn't say the FDA wants to do this—it's doing it right now.
According to Science magazine, it costs, on average, $231,000,000 and takes twelve years to do the necessary testing on a drug to receive FDA approval. If difficulties arise in the testing stage, the cost can be considerably more. This sheer financial burden keeps any number of useful drugs off the market. Pharmaceutical companies often don't bother with the necessary testing on promising drugs because they doesn't feel they will make back their investments. Even if a pharmaceutical company moves full speed ahead, cures are still, for the most part, twelve years from market. The FDA guidelines are known to be so strict and so all-pervasive that clothing manufacturer Lees can say of its Relaxed Riders jeans: "If they were any more relaxing, we'd need FDA approval."
Even worse than suppressing newly discovered drugs is the fact that drugs discovered years ago will never receive FDA approval and therefore can never be marketed. Who is going to spend twelve years and $231,000,000 proving the safety and effectiveness of a drug that anyone can then manufacture? No pharmaceutical company in the known world, that's for sure.

In the scheme of things
I'm not as important as
Dr. Jonas Salk.
These many hurdles are keeping essential drugs and treatments from the American public. Jane S. Smith observes in her 1990 book, Patenting the Sun: Polio and the Salk Vaccine,

As Jonas Salk has often remarked, it would be impossible to repeat his polio work today, when such ventures need to be passed by human-subject review boards and peer review boards and various other qualifying agencies. In 1952 you got the permission of the people involved and went out and did it, and then wrote up your results in a scientific journal. If something terrible happened, the blame would be on your head and the blood on your hands, and of course your career would be over—but in the planning stages, at least, life was a great deal easier for the medical experimenter than it has since become.

By today's standards, the Salk vaccine (which was used widely starting in 1953) would not have been available until the mid-1960s—providing that Dr. Salk could have found a pharmaceutical company willing to gamble $231,000,000 on his vaccine. With current FDA guidelines, polio might be a common disease even today.

If we are not
our brother's keeper,
at least let us not be
his executioner.
Imagine what the FDA would have to say about these unorthodox medical practices:

They came to Beth-saida, and some people brought a blind man and begged Jesus to touch him. He took the blind man by the hand and led him outside the village. When he had spit on the man's eyes and put his hands on him, Jesus asked, "Do you see anything?"

He looked up and said, "I see people; they look like trees walking around."

Once more Jesus put his hands on the man's eyes. Then his eyes were opened, his sight was restored, and he saw everything clearly. (Mark 8:22–25)

There some people brought a man to him who was deaf and could hardly talk, and they begged him to place his hand on the man.

After he took him aside, away from the crowd, Jesus put his fingers into the man's ears. Then he spit and touched the man's tongue. He looked up to heaven and with a deep sigh said to him, "Ephphatha!" (which means, "Be opened!"). At this, the man's ears were opened, his tongue was loosened and he began to speak plainly. (Mark 7:32–35)

Spitting! Can you imagine!

Half of the modern drugs
could well be thrown
out of the window,
except that the birds
might eat them.
As Julian Whitaker, M.D., points out:

In medical school I was taught that the only tools that work to help people are drugs and surgery. In the twenty years since then, I have seen that much of what I was taught is just plain wrong.

The medical establish-ment has been wrong about the big killers and cripplers like heart disease, stroke, cancer, diabetes, high blood pressure, obesity, and arthritis. Wrong about the origins of these diseases. And wrong about how to remedy them. Their record is shameful.

As young doctors we all take a solemn oath to uphold human life and well-being above all else. Sadly, it seems today's physicians care more about their profession than their patients.

Traditional Western medicine is known as symptomatic medicine. It diagnoses and treats symptoms. This is fine—and for the elimination of certain symptoms there is nothing like symptomatic medicine. To pretend, however, that symptomatic medicine represents the full range of healing and health enhancements available is a severely limited view. In fact, the two reasons (neither of them medical) the human life span has tripled in the past 400 years are plumbing, which took septic waste away from homes, streets, and cities; and transportation, which made fresh fruits and vegetables available year-round. The majority of lives saved by modern medical science can be summed up by the Three A's: Anesthesia (which permits surgery), Antiseptics, and Antibiotics.
While symptomatic medicine is marvelous, it does not justify our current attitude, which was summed up by George Bernard Shaw: "We have not lost faith, but we have transferred it from God to the medical profession." Many of the alternative methods of obtaining, maintaining, and enhancing health should be, if not encouraged, at least not forbidden by the FDA.

The first time
I met and embraced
Judy Garland,
it made pharmaceutical history.

Not that genuine, bonafide, certified quacks don't exist. They do. But these charlatans would best be put out of business by a few civil lawsuits from disgruntled patients than from the meddling of the government, which is generally too slow to act and then overreacts.

The Food and Drug Administration is intimately connected with the American Medical Association as well as the handful of pharmaceutical companies which create and manufacture the majority of prescription drugs. Working at the FDA, being on the board of the AMA, and working for any of the large pharmaceutical companies is like playing musical chairs. The high-paying jobs—the gold ring on the merry-go-round—are at pharmaceutical companies. The best way to get a raise is to become a "public servant" for a couple of years and spend some time at the FDA or AMA.

Politicians frequently own pharmaceutical stocks. For example, when George Bush became vice-president, the New York Times reported, "The Vice President still owned the Eli Lilly stock upon taking office. It was his most valuable stock holding." Dan Quayle's family owns an enormous amount of stock in Eli Lilly. When Bush left the CIA in 1977, he was made the director of Eli Lilly (appointed by Dan Quayle's father), a post he held until 1979 when he began running for vice-president (with a generous campaign contribution from guess who).

While vice-president, Bush made what the New York Times called "an unusual move" when he "intervened with the Treasury Department in March in connection with proposed rules that would have forced pharmaceutical companies to pay significantly more taxes" (New York Times, May 19, 1982).

Upjohn Co., which makes Halcion,
the most widely prescribed
sleeping pill in America,
has confirmed that it submitted
incomplete data on the side effects
of the controversial drug
to the Food and Drug Administration
when it sought approval
to sell the drug here.
Alternative healing methods directly threaten the profitable prescription drug business. Here—as with the banning of marijuana—we see not just old-time religion, but good old corporate greed as a motivating factor. To quote Dr. Whitaker again:

The U.S. government's recommended daily allowances (RDA) for vitamins and minerals are insufficient. Powerful food lobbies work overtime to keep these figures low. A nutrition label may proudly state it contains 100% of the RDA for Vitamin C. And since the RDA for Vitamin C is only 60 mg per day, the product looks good. But consider that some medical research puts the optimal intake of Vitamin C at 3,000 mg per day. Now, the manufacturer's claim seems ridiculous, as it contains only 2% of the optimal intake.

And now the FDA wants to limit vitamin supplements to the recommended daily allowance. Larger doses would require a doctor's prescription. This means (a) doctors will be paid to write the prescriptions and (b) only certain authorized pharmaceutical companies will be able to manufacture the pills. Is the FDA really concerned that some of us are taking too much vitamin C?

We must free science and medicine
from the grasp of politics.
The FDA does not, by the way, sit quietly in Washington rubber-stamping its approval or disapproval on various proposals. It has its own army of armed agents who—augmented by state and local law enforcement authorities—make raids. For example, here is how Saul Kant, director of the Life Extension Institute, described a typical FDA raid:

On February 26, 1987, an armed force of about 25 FDA agents, U.S. marshals, and members of the Hollywood, Florida, police department smashed down the glass doors of our store at 2835 Hollywood Boulevard, and stormed into our nearby warehouse with guns drawn. As Bill Feloon, the vice president of the Foundation, was trying to leave the warehouse to find out what was going on at the building, he suddenly found himself staring down the barrel of a .45 caliber pistol, which belonged to a member of a second group of FDA agents, U.S. marshals, and police officers, who were simultaneously attacking the warehouse.

The FDA can, overnight, put a nutritional supplement manufacturer out of business.
To say that the FDA sometimes overreacts is an understatement. When some truly despicable person laced Tylenol with cyanide in 1982, resulting in seven deaths, what did the FDA do? The answer you'll discover every time you open a bottle or a package of practically anything—tamper-resistant packaging. Notice it's called tamper-resistant packaging and not tamper-proof packaging. That's because no packaging is truly tamper-proof. Any deranged person with a hypodermic needle can poison any product wrapped in plastic, paper, or cellophane. To make the food and drug supply truly tamper-proof would require metal and glass packaging for everything from candy bars to loaves of bread to boxes of cereal.

Allen Ginsberg said he saw
the best minds of his generation
destroyed by madness.
I have seen
the best minds of my generation
go at a bottle of Anacin
with a ball-peen hammer.
Nonetheless, the FDA requires certain tamper-resistant packaging on certain consumable products. How much time do you spend each day removing tamper-resistant packaging? If it's only a minute a day, over 70 years of package opening, you will have wasted 425 hours thanks to FDA overreaction. More than 17 days (and these are 24-hour days) of your life will be spent complying with an FDA regulation which fails to solve a problem we no longer have.
Fortunately, whoever was insane enough to poison Tylenol in the first place stopped doing it. Voluntarily. And, thankfully, there have been few "copycat" occurrences. But this had nothing to do with tamper-resistant packaging. If some nut wants to randomly poison innocent people, he or she still can.
It is our right to seek the health care we choose. Whether it's taking drugs not yet approved by the FDA, visiting "unorthodox" healers (from chiropractors to acupuncturists to witch doctors to faith healers to prayer therapists), purchasing health machinery (did you know you can't buy oxygen—or even plastic tubing used to transport oxygen—without a prescription?), or anything else that does not physically harm the person or property of a nonconsenting other, it ain't the FDA's business if we do. (But, FDA, please keep the rat droppings and insect parts in my frozen pizzas down to an absolute minimum.)


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