from Jon Barron (http://www.jonbarron.org)

(In view of recent events, I thought it would be worthwhile to post this excellent article of Jon Barron's - DQ)

The FDA and
Government Regulators
Jon Barron

As Kristen mentioned, this newsletter has a large international following, so for the most part, I try and avoid issues that are specific to the United States. But the FDA is American in name only. Every country has its own version of the FDA working to limit your right to buy and use the health products of your choice. Baseline Nutritionals, the company that distributes my line of premium formulas, currently ships to over 30. But that list is constantly changing. Recently, for example, Austria, Germany, Portugal, and Switzerland started seizing packages at customs – making it impossible to ship to them for the time being. Suddenly “enzymes” were dangerous. “Pain relief” was dangerous. “Building the immune system” was dangerous. "Stuff and nonsense," of course; but it has temporarily denied people in those countries the ability to purchase products they may want and need. So the lessons of the FDA are applicable to all countries. And with that in mind…

When I first started researching Lessons from the Miracle Doctors, it was my intention to be as evenhanded as possible concerning the FDA. Too many people in the alternative health community go absolutely wacko when it comes to government agencies. I knew there were many things the FDA did wrong. I knew they were a bureaucracy out of control. I knew that they almost unthinkingly tow the party line -- that is, the medical community and the pharmaceutical industry point of view. But I assumed that at some base level, they were really trying to do a good job.

As it turns out, the situation is more complicated than that.

Now, to be fair, there are many, many good, conscientious people working for the FDA. I've talked to a number of them. (It's not hard. They're available to you if call up. They're very nice.) The problem is that the nice people don’t really control the agenda. The reality is that in many ways, the FDA follows the same bell curve that I talked about in Why Your Doctors Do You Like They Do, June 21, 2004.

• At the bottom of the curve, particularly out in the field, there are a handful of petty bureaucrats -- little people who sit behind very big desks -- who get off on wielding power and intimidating anyone who crosses their path. (I would think that everyone around the world has had unfortunate contact with people like this.)
• In the middle, and comprising the biggest part of the curve, are the hardworking, conscientious people, trying to do the best they can. Some are open minded, and some religiously follow the party line – but all are trying to do the best they can, and in their way protect consumers.
• At the executive level, there are some very bright people – but unfortunately, too many who are negotiating their next job in the pharmaceutical industry -- or who have just arrived from there to work at the FDA. You can't have a relationship between a multi-billion dollar industry and the people entrusted to oversee it, and not expect, given enough time, to see people crossing the line.

Anyway, that said, for your enjoyment, here's a quick summary (just the tip of the iceberg, if you will) of the FDA: the good, the bad, and the ugly.

The Good

When you consider the scope of the issues involved and the number of consumers involved, they actually do a reasonably good job at policing

• Food safety
• Harmful medications

Yes, periodically people do indeed get sick. People even die. But the reality is that all life entails risks. Keep in mind, that according to the Centers for Disease Control, gastrointestinal complications from using aspirin and other NSAIDS are responsible for over 76,000 hospital visits and over 7,600 deaths each year in the United States alone. (Something worth keeping in mind, just for perspective, the next time you hear about an FDA assault on some herb such as ephedra.)

The bottom line is that it is not the role of the FDA to eliminate all risk. That’s not possible. Just to minimize as much unnecessary risk as is reasonably practical. Problems arise when regulating agencies like the FDA either forget the limitations of that goal, or deliberately choose to ignore it for political, bureaucratic, and yes, in some cases, financial reasons.

The Bad

The main source of information for the FDA’s regulation of drugs is the pharmaceutical industry itself. In effect, the FDA simply evaluates the test results submitted by these companies in support of their own drugs -- no kidding. That in itself is a clear-cut conflict of interest, but there's more. In much the same manner that the military industrial complex has blurred the lines between the defense contractors being overseen and the military agencies overseeing them, a revolving door has also been established between FDA executives and the large food and drug companies.

• Congress itself revealed in 1969 that out of 49 high-level officials who had left the FDA, 37 of them moved immediately into high-level corporate positions in the companies that they had previously been in charge of regulating. Over the years, about half of all FDA officials end up in executive positions in the companies that they regulate.
• In 1975, the General Accounting Office reported that 150 FDA officials owned stocks in the companies they were supposed to be regulating.
• The US Securities and Exchange Commission has, on several occasions, reported allegations of insider-trading of pharmaceutical stocks by FDA employees.

Case Study I: Aspartame (NutraSweet® and Equal®)

• Aspartame was once considered (before it was approved as a food) by the Department of Defense as a potential biological-warfare neurotoxin.
• At temperatures of about 85 degrees, aspartame breaks down into its components. These include: methanol (wood alcohol, known to street alcoholics as the alcohol that makes you go blind), formaldehyde (a neurotoxin), formic acid (ant venom), and diketopiperazine (a known carcinogenic that causes brain tumors in animals).
• According to the FDA's own audit on aspartame, the Bressler Report, aspartame triggers brain tumors, mammary tumors, pancreatic tumors, ovarian tumors, pituitary adenomas, uterine tumors, etc. A senior FDA toxicologist, the late Dr. Adrian Gross, who tried to prevent the approval of aspartame, told Congress that it violated the Delaney Amendment because it triggered brain tumors (Congressional Record SID835:131 - 8/1/85)
• Aspartame has also been shown to trigger birth defects and miscarriages -- not just if the mother uses it, but the father also. And now, because of new FDA directives governing the use of aspartame, it has appeared in a whole range of products that we use everyday. (l996, Dr. David Kessler, then head of the FDA, gave blanket approval for aspartame.) This may be a major reason that 50% of first pregnancies in the US now end in miscarriage.
• Before aspartame was approved in beverages in 1983, the National Soft Drink Association created a THIRTY PAGE PROTEST (that was later read into the Congressional Record) declaring that aspartame was NOT stable, and that it could actually make unwary users FATTER!
• In 1983, the average annual consumption of artificial sweeteners in the United States (primarily aspartame) was around 3.5 lbs. per person. By 1991, consumption had risen to an astounding 17 lbs. per person.
• The FDA receives more complaints about aspartame (over 10,000 official complaints) than for all other non-drug products or substances put together. In fact, between 78-85% of all complaints the FDA receives concern aspartame.
• Symptoms caused by aspartame include, among many others: chronic fatigue and immune deficiency syndrome; grand mal seizures; decreased vision; pain in eyes; ringing in ears; headache; confusion; etc; etc; and death. The FDA has its very OWN list of 92 SYMPTOMS. Note: Five deaths were reported prior to 1987. Since then, figures have not been made public.
• The FDA itself kept aspartame off the market for 16 years until it suddenly granted approval. The story of that approval follows.

So how the heck did this neuro-toxin end up becoming one of the most omnipresent food additives of all time? As Deep Throat told Bob Woodward, “Follow the money!”

The story begins in 1974 when aspartame was first approved, but the approval was pulled when issues arose concerning aspartame’s tendency to cause brain tumors. These concerns were verified when in 1977, an FDA task force submitted a 15,000 page document that "uncovered serious deficiencies in Searle's integrity" and "revealed a pattern of conduct which compromises the scientific integrity of the studies." Specifically, the FDA Task Force found that Searle routinely took the test animals that developed tumors (and there were many), cut out their tumors, returned them to the study, and then documented them as non-tumor.

But if the FDA task force did not want to approve aspartame, we are once again faced with the question: how did aspartame get final approval? Again the answer lies in Deep Throat’s advice to Bob Woodward, “Follow the money.”

In 1977, Donald Rumsfeld (former member of Congress and Chief of Staff in the Ford Administration) was hired as president of G.D. Searle, the maker of aspartame, at a salary of $2 million plus $1.5 million in bonuses between 1979 and 1984 -- compensation he more than earned, as you will soon see. Mr. Rumsfeld then proceeded to hire a number of other former government officials and members of the Ford Administration to serve as counsels and representatives for Searle (including: high level spokespeople from the Civil Aeronautics Board, the Ford White House, and the Department of Transportation).

These efforts had an immediate payoff in that Searle was able to convince U.S. Attorney William Conlon, who was assigned to the case, to take no action against Searle or aspartame, despite repeated prodding by Richard Merril, Chief Counsel to the FDA. Interestingly enough, a year later, Mr. Conlon, took a position with the Searle’s legal firm, Sidley and Austin -- as Deep Throat predicted.

But the big pay-off came in 1983, when the Commissioner of the FDA, Dr. Arthur Hull Hayes, approved NutraSweet for soft drinks two months before leaving office. A couple of months later, after he had retired from the FDA, he accepted a position as Senior Medical Advisor to Searle's public relations firm, Burson Marsteller -- at the rate of $1,000 per day.

Thank you Deep Throat!

PS: Sucralose, the new darling of the food industry is no better. See: Dr. Mercola's comments on the issue.

Case Study II: L-tryptophan

Until the fall of 1989, L-tryptophan was considered to be one of the safest and most powerful natural medicines for treating a long list of psychiatric conditions. Found abundantly in nature (two well-known sources are milk and turkey), tryptophan is one of the only substances known that actually produces serotonin. Increased levels of serotonin decrease pain sensitivity, stop depression, and lessen anxiety and stress. L-tryptophan had been sold and used extensively since the mid-60s as, among other things, a powerful anti-depressant, pain relief agent, and sleep aid. It worked! By 1989, sales of L-tryptophan were around $180 million a year. It was safe! No significant side effects had ever been noted in the 25 years it had been in wide use, and there were over 200 medical studies supporting its efficacy and its safety.

Then, in late 1989, the deaths of 38 people from a condition called Eosinophilla-Myalgia Syndrome were linked to the use of L-tryptophan. In fact, after an extensive investigation, the Center for Disease Control announced in the New England Journal of Medicine that the problem was not actually with L-tryptophan, but with a batch of contaminated products produced by the Japanese manufacturer Showa Denko. In point of fact, the FDA confirmed this in their official publication, FDA Consumer, which stated, “It appears the problem is not with the amino acid itself, but rather with the product becoming contaminated as a result of a change in the firm’s manufacturing process.”) Nevertheless, and given this fact, the FDA response was extraordinary.

Rather than just recall the contaminated L-tryptophan, the FDA chose to ban all L-tryptophan totally from the market -- indefinitely. You need to understand that up until that banning, L-tryptophan was available over-the-counter at health food stores everywhere. It had been used by millions of people for years without a single adverse incident ever being reported.

Now to be sure, recalls of contaminated products are quite common. Tuna, apples, strawberries, orange juice, raspberries, and grapes have all been recalled over the past few years. Tylenol, of course, was recalled when random bottles were intentionally contaminated. And, as many of you will remember, Jack-in-the-Box was temporarily shut down in the Northwest, when some of their meat became contaminated with E-coli bacteria and caused several deaths. All of these products were recalled by the FDA, but in each and every case, once the problem was identified and cleaned up, the product was allowed back on the market.

Not so with L-tryptophan. The FDA didn’t just remove the contaminated batches of the amino acid. They forced the recall and destruction of all L-tryptophan destined for human consumption, and it was totally banned for sale, indefinitely. Even though the source of the contamination was found and corrected, the FDA continues to ban L-tryptophan to this day -- almost 10 years later. Why?

Deep Throat again provides the answer.

At the time of its banning, sales of L-tryptophan in health food stores were running around $180 million a year. It sold so well because it worked. It helped with everything from depression to anxiety to stress. Unfortunately, it worked too well, was a natural substance so it couldn’t be patented, and was priced too low. This was unacceptable; and so, when the first excuse presented itself, L-tryptophan was pulled from the market.

Amazingly, as “chance” would have it, within 4 days of the banning of L-tryptophan, Prozac was the cover story in Newsweek magazine. Almost, as if by a miracle, it seems, Prozac, which is patented and is far more expensive than L-tryptophan, was there to fill the gap and became the miracle drug to take the place of L-tryptophan.

Thank you once again, Deep Throat.

PS: Interestingly enough, the FDA permits L-tryptophan to be added to baby foods and used in intravenous nutrition solutions. So deadly. So deadly. Thank goodness the FDA protects adults from this deadly toxin.

PPS: The FDA has finally relented and quietly allowed L-Tryptophan to be marketed again. However, the official FDA position on L-Tryptophan, published as recently as July 2004, is still that "A virtually unequivocal epidemiological link between ingestion of products containing manufactured L-Tryptophan and onset of Eosinophilia-Myalgia Syndrome (EMS) exists."

Case Study III: Food Irradiation

See Genetic Engineering and Irradiation, March 17, 2003

The Ugly

• In the early 1990s, The FDA raided the following establishments: seventeen health food stores in Texas; a Utah-based herb company distributing evening primrose oil; a dietary supplement company in Oregon; a black-currant oil distributor in Illinois; the Life Extension Foundation in Florida; an alternative medical clinic in Tacoma, Washington; Nutricology in San Leandro; herbalists in northern and southern California; and many other small businesses throughout the country.
• Stevia is a plant that provides a safe, natural, very powerful sweetener and no calories. It has been used for hundreds of years in South America and for almost 30 years in Japan (after extensive testing by both the Japanese government and the scientific community proved its safety). Stevia and its extracts have captured over 40% of the Japanese market. Major multinational food companies like Coca Cola and Beatrice foods, convinced of its safety, use stevia extracts to sweeten foods for sale in Japan, Brazil, and other countries where it is approved. So why isn't it available here in the United States? Well, it turns out it has one major negative: it's cheaper than any of the artificial sweeteners currently in use and would, therefore, severely cut into their profits. (Note: the Herb Research Foundation filed a Freedom of Information Act request with FDA in the early '90's for information about contacts between Nutra Sweet and the FDA about stevia. It took over a year to get any information from the FDA, but the identity of the company who prompted the FDA action was masked by the agency.) Since 1987, the FDA has done everything in its power to obliterate stevia from the market, including:
• Classifying stevia as a "dietary supplement" so that it can't be used to sweeten foods.
• Personally "visiting" companies and ordering them to stop using stevia
  Imposing an import alert on stevia
• And in 1998, actually going so far as to seize cookbooks that used stevia in their recipes

And remember, not only has stevia been proven safe and non-toxic over a hundred years of use and millions and millions of doses/servings; but as it turns out, stevia actually has several health benefits. So lighten up, FDA.

• Probably the classic FDA action of all time was the raid on the Kent, WA medical clinic of Dr. Jonathan Wright in search of "illegal" drugs such as Vitamin C, B12, and folic acid. What made the incident so remarkable was that one of the clinic employees managed to call the local media, who then captured the incident on videotape. Led by the FDA:
• Dozens of state and federal law enforcement officers burst through the clinic doors, guns drawn.
• They ordered all staff and patients to freeze, stuck guns in people's faces, ordered people to get their hands up, and yanked phones from the walls.
• They then seized all equipment, records, documents, and, of course, the "illegal" vitamins.

As the Kent police said after the incident, "The whole incident has been extremely embarrassing. We look and feel like class "A" idiots. The next time those jerks [the FDA] ask us for some help, we'll let them find some other patsies. It would be pretty funny unless you saw the terror on the faces of those people." (Note: they had participated in the raid because they had been told by the federal authorities that they would be raiding a major drug dealer. They just hadn't been told that the drugs in question were vitamins.)

Conclusion

The bottom line is that the FDA, the medical establishment, the drug companies, and the rest of the system get away with this nonsense because we let them.

• We need to take back control of our own health. That’s why I wrote Lessons from the Miracle Doctors, to teach you how to do just that. If you haven’t already done so, you can download a copy for free at www.jonbarron.org.
• We need to stop equating health with the temporary elimination of symptoms -- and insist that our health care providers do the same. The first injunction of the Hippocratic Oath, which all doctors swear to, is: "First do no harm." We need to insist that our health care system adheres to that injunction.
• Hamlet may have been addressing doctors when he said, "There is more in heaven and earth than is dreamt of in your philosophy." Look, doctors are dedicated practitioners of merely "one branch" of the healing arts. They are not gods. We need to take back the god-like powers we have given them over our health. In most states, it is illegal to treat cancer with anything other than the three "approved" modalities: Cut, Burn, and Poison (surgery, radiation, and chemotherapy). This is unconscionable and intolerable.
• We need to demand fairness from the powers that be. The vast majority of medical procedures and pharmaceutical interventions used throughout the world are not based on scientific studies. They are based on anecdotal evidence. This is a surprise to most people, but the simple truth is, as reported in the Journal of Medical Ethics (1992, 18:117), "only about 15 percent of medical interventions are supported by solid scientific evidence; in other words 85% are not." So the question is, why is the FDA insisting that 100% of all alternative health treatments be backed by scientific "proof" -- and throwing people in jail and shutting distribution outlets down if the do not comply? It's certainly not a question of public safety. If drugs that kill over 100,000 people a year (in the United States alone) can legally be promoted and sold, then it makes no sense to hold herbs that may be responsible for only 5 or 10 deaths a decade (and that's when severely overdosed) to a standard some 600% more stringent? We must demand a level playing field.
• There is certainly a need to control the use of pharmaceutical drugs. Some agency needs to be in charge. Maybe the FDA is the agency that can do it, but not until they have been totally restructured, and brought back into line, and their unconscionably cozy ties to the pharmaceutical industry severed.
• And yes, there needs to be some agency in charge of alternative healing. Make no mistake: an examination of alternative health practioners will find the same kind of bell curve that we’ve seen for physicians and the FDA: a small percentage of charlatans and incompetents; those with merely passable skills; the dedicated and competent; and the brilliant. Somebody needs to regulate them. And somebody needs to regulate the potions, lotions, and devices that are used. But that someone is most assuredly not the FDA as it now stands or any physician dominated group.
• Asking medical doctors to oversee alternative healing is like asking homepathic doctors to run the AMA. It can't work. The medical establishment doesn't like alternative healing; they have no feel for it; and they view it as competitive. Yes, there are certainly individual doctors who can relate, but as a whole, the medical establishment is extremely hostile to all forms of complementary medicine. We have repeatedly seen the antipathy the AMA and the FDA have for alternative healing. There's no way in the world they can function as overseers. The only solution is to create a new agency staffed and run by alternative healers to oversee the practice of the alternative healing arts -- and then in 10 years, after this new agency has been infiltrated by the financial interests that back alternative healing, throw everyone out and start again.