Codex Threatens Supplements?
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Penthouse, September 1999     Also reprinted on Dr. Matthias Rath's site at
 http://www.rath.nl/menue/news_content/usa/aktuell-usa/ph_september_1999.htm

WARNING

Your Next Bottle Of Supplements Could Be Your Last

 Article by Gary Null

Americans freedom of choice is under attack from big medicine, the pharmaceutical establishment and their allies in big government and the United Nations.

Every year, the largest increase in the U.S. gross national product is in the medical sector.  It's been estimated that $600 billion could be trimmed yearly from our $1.3 trillion medical bill if we were to eliminate al unnecessary, overused, unproved, and dangerous procedures.  We have 100 million what I call "medical refugees" in this country- people who have given their absolute trust, faith, and life savings to the orthodox approach, only to find that this route has failed them. In recent years these people have begun to look elsewhere for answers-resulting in big medicine, the pharmaceutical establishment, and their allies in big government all joining forces to protect their own interests. These threatened groups engage in fear-mongering before Congress to get legislation that would sic state medical boards on alternative therapies, let dietitians control the dispensing of nutritional advice, and keep the public from having freedom of choice by turning as many nutrients as possible into prescription drugs. This is what the future will bring unless we take action.

Not far into the twenty-first century you may be saying so long to your St. John’s Wort, goodbye to your ginkgo biloba. These and many other supplements may become things of the past, at least as reasonably priced over-the-counter items.

Picture the following scenario: It’s winter, in a year just past the start of the new millennium. You’ve been pushing yourself a little too hard, and you feel a cold coming on. You decide to get some vitamin-C-plus-bioflavonoid tablets; this particular supplement also contains selenium and has helped you keep cold symptoms at bay many times in the past. Taking some now seems like a prudent thing to do. So you pick up the phone and call your doctor to make an appointment. When you finally get through and can talk to a human, you are told that the doctor-your primary-care physician- is really busy, and so are all his associates in the HMO, but luckily they can squeeze you in two days. Two days later your cold is already hitting full force, and it’s snowing heavily, but you figure, what the heck, the supplements may still help. So you decide to go ahead and get them. After bundling yourself into the car, you drive several miles past the local drugstore to the doctor’s office. There, after languishing for an hour and a half in the crowded waiting room, you see the doctor for a cursory four-minute examination, during which you blood pressure’s a little high because you’re nervous about getting the tablets. But your powers of persuasion are good-you explain how many times the C-plus-bioflavonoid supplements have worked for you in the past- and the doctor’s a nice guy anyway. Triumphant, you leave the office tightly clutching your little white script.

"Yes!" you say to yourself. "I’ve done it! I’ve got my prescription!"

In the car again you drive over icy roads the several miles homeward, stopping at the drugstore. You give the prescription to the pharmacist, who, like the doctor, is swamped with work. You’re stuck cooling your heels in the store aisles for a good 20 minutes until the pharmacist has a chance to fill the prescription and you can pay for it. Once you’re home, the feeling of triumph you had in the doctor’s office has faded somewhat. It’s been a long day, full of waiting. At the end of it, you had to pay what seemed like a small fortune to get a few tablets. Plus by now your cold really has you in the its grip. You think back fondly to the days when you could stroll down to the drugstore anytime, pick whatever vitamin, mineral, herb, or other nutritional supplement you wanted right off the shelf, and pay a reasonable amount of it.

"Ah for the good old days," you say to yourself, "the days before Codex Alimentarius got its way"

Codex Alimentarius, which means "food code" in Latin, is the name of a United Nations commission that operates as part of the World Health Organization. The Codex Alimentarius Commission’s mandate is to set international standards for trade in all kind of food products. Its concerns include raw-and processed-food standards, pesticide and other contaminant levels, nutritional content, and labeling. Codex also is concerned with global trade rules for health supplements, and it is what the commission is aiming to do in this field that is really scary.

First, the Codex Alimentarius Commission wants to establish a world guideline saying that no dietary supplement can be sold for preventive or therapeutic purposes. Actually, in the U.S. we already have a labeling constraint to this effect: The Dietary Supplement Health and Education Act of 1994 prohibits claims on supplement labels that relate to treatment or prevention of disease other than classic nutrient-deficiency diseases, like scurvy. That’s why our vitamin bottles don’t tell us much about what their contents are good for-they’re not allowed to.

Second, the Codex-Alimentarius Commission wants to limit over-the-counter sales of dietary supplements to those of low or R.D.A. dosage, the kind that prevent deficiency diseases but not chronic diseases like cancer. Dietary supplements of higher potency-the dosages that work to fortify the immune system and stave off aging and chronic disease-would become pharmaceuticals. You would have to get them from a pharmacist.

Today, many of the newly popular supplements, such as those being taken for their immune-enhancing powers, have never been assigned a recommended daily allowance. These R.D.A.-less substances, such as bioflavonoids, selenium, chromium, and coenzyme Q10, also would be classified, according to the Codex scheme, as drugs, meaning you’d need a prescription to get any of them.

And there’s more on the Codex agenda. The group wants all new supplements to have to be approved by the commission before becoming available. Without approval there’d be no legal sale anywhere. That’s another aspect of what the Codex Alimentarius Commission wants to do- it wants to make its guidelines universal. The General Agreement on Tariffs and Trade that the U.S. and other nations have signed contains an escape clause on regulations that allows us to set our own standards. But Codex wants to eliminate that clause and force Americans into the commission’s restrictive system. It speaks in terms of governments "harmonizing" their rules so that everyone in the world sticks to the same standards. "Harmonizing" their rules so that everyone in the world sticks to the same standards. "Harmonization" might be a nice concept if you were talking about the whole abiding by some minimum standards on

democracy, decent wages, human rights. Unfortunately, in this case the harmonized standards will mean nothing less than the loss of our capacity to maintain and care for our own bodies in the ways we judge best. We’d be losing the ability to educate ourselves on how to enhance health and then act on what we’ve learned. The gainer in all this would be the medical establishment, particularly the large pharmaceutical companies. What it boils down to is that there’d be a medical monopoly controlling our very body chemistry.

Sometimes threats to our freedom remain in the shadows until it’s too late. That may turn out to be the case with the Codex Alimentarius Commission, which certainly has not been a household term in America. Our media seem to have been asleep at the wheel when it comes to reporting on this outfit.

The Coded Alimentarius Commission, composed of member governments, exists under the joint auspices of the UN’s World Health Organization and Food and Agriculture Organization as part of a food-standards program. The commission meets in Rome or Geneva every two years, with smaller get-togethers in various locales all over the world at other times. While it is concerned with protecting the health of consumers, it’s also a trade group, and of the international organizations that send delegates to Codex, more that 90 percent represent large multinational corporations.

Codex is not an organization in which the American public- or any other country’s public, for that matter- is given a voice. Although there’s a one-nation, one-vote rule, those representing their respective countries are unelected bureaucrats. There is no system of accountability where- by these bureaucrats would have to face the citizens whose lives their decisions affect. The Life Extension Foundation, a watchdog group that has taken the trouble to look into the goings-on at Codex meetings, gives details on the group’s workings:

"The Codex Alimentarius Commission as an international body makes little or no provision for the minimum requirements of representative governance. For example, Codex Committee chairmanships can and have remained vested in the hands of a particular nation-state for decades at a time, with no mechanism for either rotation of chairmanships or accountability for the acts or particular nations as the chair of a particular committee. Many nations have retained chairmanships in an uninterrupted fashion for the last 30 or more years."

The watchdog organization goes on to explain that "committee chair nations wield considerable power under the Codex system, since a chair nation is responsible not only for the costs associated with the assumption of that role but also for the shepherding of committee recommendations throughout the Codex process. The Codex process contains no meaningful system of accountability for acts of chair nations or mechanism for containment or review of the considerable powers wielded by chair nations.

The Life Extension Foundation also points out that meaningful consumer representation at Codex is virtually nil. And it has this to say about the U.S. delegation to the organization: "Within the United States delegation, the voting delegate is assisted by a group of nonvoting delegates who are selected by either the Department of Agriculture and/or the Food and Drug Administration under an ill-defined and unregulated system in which the agencies openly represent vested commercial interests or commercial interests thinly disguised as consumer groups, with nor requirement that genuine consumer or public interest be represented at all."

"Consumers took a hit in their wallet,"
said Attorney General Reno,
"so that these co-conspirators could reap hundreds of millions of dollars."

The Codex story gets even more interesting when you find out who’s behind the proposed new rules. The proposals were originally put forth by

the German delegation to the commission, a panel sponsored by three giant drug companies- Hoechst, Bayer, and BASF. These are none other than the daughter companies formed after World War II when Nazi Germany’s notorious I.G. Farben cartel was disbanded. (In May of this year, two federal class-action lawsuits were filed against Bayer AG, Hoechst AG, and Schering AG, charging these German companies with participating in Nazi medical experiments, some of which were under the direction of Dr. Joseph Mengele.) As the Life Extension Foundation points out, it is such companies that are now the firmest supporters of the proposals that would so drastically curtail our healthcare freedoms.

(Earlier this year BASF and the Swiss drug company La Roche Holding AG pleaded guilty to the largest antitrust conspiracy to fix vitamin prices uncovered to date. They agreed to pay fines of $500 million and $225 million, respectively, for raising and fixing vitamin prices and allocating their volume of sales and market shares. "Day by day," Attorney General Janet Reno said, "consumers took a hit in their wallet so that these co-conspirators could reap hundreds of millions of dollars in additional revenue.")

It’s instructive to look at the supplement situation in Germany today; one can get an indication of the way things would go if the Codex proposals are adopted. In germane, until 1996, one could buy, freely, 500mg vitamin-C tablets, the way you can here. Now the highest dosage generally available to Germans is 200 mg; anything higher is sold through pharmacists only- at extremely high prices. Likewise, generally available vitamin E capsules go up to 45 I.U. only, and B1 is limited to 2.4 mg.

Other countries also provide a preview of what may be ahead for the U.S. In Norway, all supplements that exceed R.D.A. levels are considered drugs. Examples of cutoff potency levels are 200 mg of vitamin C, 2.4 mg of B1, 2.8 mg of B2, 4.2 mg of B6, and 32 mg of niacin. Many natural substances are available in Norway only through the very costly prescription route, if they’re available at all. A black market in supplements has emerged. In England, it recently took the objections of a large consumer lobby to defeat a measure before Parliament that would have banned vitamin B6 beyond the less-than-therapeutic dosage of ten mg. And in Europe as a whole, the European Economic Community has said that if an herb is medicinal or affects physiological function in any way, it is a medicine and should be sold as a drug.

Closer to home, in Canada, herbs with medicinal effects- this is, any herb for which claims are made that it improves health- are classified as drugs. The supplements tryptophan and L-carnitine, once available in Canadian health-food stores for $14 per 100 capsules, are now available only by prescription- for $120 to $190. In the U.S., what’s happened with tryptophan may be indicative of our future direction. In 1990, after a batch of the amino acid turned out to have been contaminated, the F.D.A. banned sales of tryptophan completely. But the substance is now available by prescription at highly inflated prices. If Americans do not take notice of the worldwide trend toward medicalization of nutrient, many of the supplements that we now take for granted we will not be able to take at all.

The medicalization of nutritional supplements might not be such a bad thing if the medical/pharmaceutical complex were in the habit of working in the public’s best interest. But anyone who thinks that this is the case is being naïve. You don’t have to look further than that bastion of the establishment The New York Times to see how pharmaceutical companies team up with physicians in the latest kind of pharmaceutical sleaze.

The results of a ten-moth Times investigation, reported on May 16 of this year, show that there’s a widespread conflict of interest when doctors recruit patients for clinical trials of experimental drugs. When a doctor gets a patient to enroll in a clinical trial, chances are good that that doctor is paid a hefty free-from about $1,000 to more than $4000- for each enlistee. A physician can significantly augment his income if he or she aggressively recruits patients into testing programs. The problem, of course, is that with the monetary incentive doctors are tempted to fudge on the requirements and restrictions as to who can safely participate in the study. And, as the Times story revealed, this happens all too frequently. Doctors overlook contraindications to a patient’s taking a particular drug. Or they enroll people in a trial who have no need for a drug at all. The power gap between doctor and patient is so great that most patients are going to agree to whatever the doctor suggests without question. Plus most patients hearing a recommendation to enter a clinical trial have no idea that money is changing hands practically as the doctor speaks.

This didn’t used to be the way things worked in the pharmaceutical-research field. As recently as the 1980s, testing of drugs was done largely by university doctors, with no monetary incentive for patient recruitment. But in the past decade, with the rise of managed care and its power to curtail the price drug companies can charge per prescription, the companies realized that the way to pump profits back up was to come out with new "blockbuster" medicines at a faster rate than previously. To quicken the pace of clinical testing they came up with the newest twist on fee-splitting- this scheme of paying doctors incentives include not just a per-person fee, but rewards for recruiting a certain number of subjects within a specified time, as well as "coauthorship" of trial-result articles that are in fact written not by the doctors, but by drug-company or research-company ghostwriters.

Research companies are another new development. It used to be that pharmaceutical companies guided their own research. Now they’re outsourcing it to new firms that have sprung up ready to take care of every aspect of research, from designing studies to finding doctors who will participate to writing papers to submitting documentation to F.D.A. Unfortunately, the whole process seems shot through with shoddiness. Beyond the ethical question of doctors being offered incentives to recruit patients is the reality that many doctors chosen by the research firms to do recruiting should not have been selected because they’re not specialists in the field for which they’re testing medicines. This seems not to worry the research companies, which aren’t picky about the experience of the doctors who are handing out unproved medicines. The name of the game these days is speed in turning out new drugs- not expertise in helping patients.

The result of such shady dealings by the pharmaceutical industry is not just its enrichment to the tune of several billion dollars. Much more serious is the sometimes life-or-death risk these practices pose for patients. And so the question becomes, is our F.D.A., which is supposed to be looking out for our lives, really doing so? The search for an answer leads to some troubling facts.

Consider, for instance, that of 198 new drugs introduced from 1976 to 1985, more than half caused unexpected side effects and had to be withdrawn or relabeled. Or consider a 1998 study reported in the Journal of American Medical Association. Serious adverse drug reactions were found to occur in almost seven percent of hospitalized patients. These were not errors of dosage or noncompliance with instructions, but simply bad reactions to the drugs. Such reactions the JAMA authors revealed, were between the fourth-and sixth-leading causes of death.

Or look at specific drugs that the F.D.A. has approved. In 1997 the diet drugs fenfluramine and dexfenfluramine were pulled from the market after they were linked to serious irreversible heart problems- and to deaths – when they were used with another drug, phentermine. This so-called fen-phen combination had been a widely advertised and prescribed drug duo used by people trying to lose weight, people who never suspected their hearts could be seriously damaged in the process. The billion-dollar-lawsuit aftermath of this tragedy is only beginning to be felt. Other popular medications approved by the F.D.A. include those called nonsteroidal anti-inflammatory drugs, used to treat, among other conditions, arthritis. According to Stanford University researcher Dr. G. Singh, writing in the American Journal of Medicine, "Conservative calculations estimate the approximately 107,000 patients are hospitalized annually for nonsteroidal anti-inflammatory drug (NSAID)-related gastrointestinal complications, and at least 16,500 NSAID-related deaths occur each year among arthritis patients alone.

A drug that has been much touted of late is tamoxifen, which recently gained F.D.A. approval to be used as a breast-cancer preventive by healthy women deemed at high risk for the disease. While tamoxifen has been used to prevent recurrence of breast cancer in those who have already had the disease, okaying its use by healthy women is troubling for a number of reasons.

For one thing, there’s the question of who’s really at high risk. The computer models used to determine risk are often little more than informed guesswork (for example, according to the Los Angeles Times, "the National Cancer Institute computer model that most doctors use to assess risk does not take genetics into account, nor the ages at which close relatives contracted the disease"). The reason this is such a critical point is that the women placed in this category are now being encouraged to take a drug that is not a benign substance. Tamoxifen carries with it a number of risks, just one of which is that it can cause endometrial, or uterine, cancer.

Giving cancer patients a drug with risk attached is understandable. But encouraging healthy individuals to take a carcinogenic substance is ethically questionable, to say the least. Recently, Judy Norsigian of the Boston Women’s Health Collective was quoted as saying such practices were "disease substitution, not disease prevention." And yet the F.D.A. approved the drug for use by the healthy. It should be noted that in doing so it opened up a market worth billions of dollars annually.

"The F.D.A. seems to relish conducting storm trooper - like raids on small business selling supplements that the agency has problems with."

Having sweetening power is allowed in their marketing. So you have the phenomenon of F.D.A. compliance officers getting after the Stevita Company, of Arlington, Texas, to destroy "offending" cookbooks and other literature, and of attempting to regulate Internet Websites dealing with the herb. James Kirkland, author of the book Cooking With Stevia, has made the point that his book is illegal, while a volume called the Anarchist’s Cook-book, which tells how to construct homemade bombs, is not. The situation would be humorous if it were not so serious.

A situation that is definitely not humorous involves folic acid. The U.S. Public Health Service was imploring childbearing-age women to take folic acid to prevent birth defects for two years before the F.D.A. finally approved the labeling claim. Folic acid, taken before and during pregnancy, has been shown to prevent babies from born with spina bifida, a condition that causes partial to full paralysis, permanent deformity, an shortened life span. It’s been estimated that during the two years the F.D.A. dragged its feet on allowing claims to this effect, more than 3,500 children were born with spina bifida- a tragedy that could have been prevented had their mothers taken folic acid.

In another area, many people today are trying to lower their cholesterol levels, and you would think that a safe way to help do this would be welcomed by the F.D.A. But one of the over-the-counter herbal products that the F.D.A. A. has been trying to declare an illegal drug is Cholestin, which is made from kind of Chinese rice fermented with red yeast and is used as a cholesterol-lowering agent. The F.D.A. recently impounded ten tons of the red yeast rice, but a court ruled that the manufacturer could continue making Cholestin while legal wrangling goes on. Cholestin is a natural supplement based on a 2,000-year-old Chinese product. The problem seems to be that it threatens the more expensive- and riskier – prescription cholesterol reducers.

The F.D.A. seems to relish conducting raids on small business selling supplements that the agency has problems with. Their storm trooper-like tactics, while not widely publicized, have not been appreciated by those affected. One example: In October 1990, according to the National Review, "an F.D.A. sting operation led t a raid on [the home and business of Kenneth Scott, the owner of a small Oregon vitamin company] by 11 armed federal marshals, nine F.D.A. agents, and a horde of local and state police officers." What was Scott’s crime? He was mailing reprints of an article from Omni magazine to customers who requested them. Because the F.D.A. did not approve of what the article reported about an ingredient in one of Scott’s products, it told Scott that it considered his mailing the article as "labeling." Scott eventually decided that he didn’t have the time and money to fight the feds and cut a deal with them.

Another example from 1990: Solid Gold Pet Foods, a California store that sold holistic pet-food products, was raided by the F.D.A. and its owner imprisoned for 114 days, because, according to the Washington Times, "a judge ruled that claims concerning her natural pet food were unsubstantiated." The newspaper went on to report that she "was released only after President Bush revised legislation on food labeling."

Another example also involves a California company, this one called Nutricology. In 1991 it was raided by the F.D.A., which seized the firm’s bank accounts and shut it down for two weeks, charging its principals with wire fraud, mail fraud, and selling unapproved drugs, unsafe food additives, and misbranded drugs. Armed agents conducted an exhaustive search of the company’s office and warehouse. In 1991 a federal judge denied the F.D.A.’s request for a preliminary injunction, and so did an appeals court to which the agency turned. In 1993, the F.D.A.’s motion for summary judgment was denied, and the company is still thriving.

Although in some cases there is vindication for health-food businesses, in many instances of F.D.A. raids the small-business people involved are totally intimidated and ruined. As Nutricology president Stephen A. Levine said when his company was under attack, "The F.D.A. will wipe out our entire industry if we left them."

The flip side of all the bad news about F.D.A. shenanigans and about risky new drugs is an avalanche of good news about the healing powers of natural supplements. That’s what makes the impending Codex actions to restrict our access to the so excruciatingly ill timed. Let’s look at just a few of the encouraging studies.

First, have you heard about the Linxian trials? Probably not. Linxian is an area in China. The trials there had nothing to do with court cases, but with a joint effort by the U.S. National Cancer Institute and the Chinese Academy of Medical Sciences to see if daily ingestion of vitamin/mineral supplements would reduce cancer incidence and mortality. Results of the experimental trials, which involved more than 30,000 people, showed that a beta-carotene/vitamin E/selenium combination had a significant preventive effect for stomach and esophageal cancer, and for stroke as well.

Another study, in another area, involved multivitamin supplements and H.I.V.-infected women. Reported in 1998 in the British medical journal The Lancet, this study showed that multivitamins improved pregnancy outcomes for these women significantly reducing rates of fetal death, as well as low birth weight and other problems for the babies. What’s more, the low-cost vitamins improved the women’s T-cell counts, a sign that their immune systems had benefited.

Studies on fish oil have been noteworthy in the medical literature lately. For instance, in a 1997 study, fish oil, compared to a placebo, lowered the number of "cardiac events" in a group of patients with suspected heart attack. Another study, published the same year, in the Journal of the National Medical Association, involved fish oil and garlic. This seemingly lowly combo did great things when taken as a supplement for a month. Unlike a placebo, which did nothing, the supplement lowered total cholesterol 11 percent, triglycerides 34 percent, and low-density lipoprotein ten percent. Things went swimmingly for fish supplements in still another study, reported in the journal Cancer in 1998. In that one, the omega-3 polyunsaturated fatty acids of fish oil were shown to lengthen survival time of cancer patients.

In human health, this is a time of opportunity, and of challenge. Information about the benefits of vitamins, minerals, herbs, and other natural supplements is growing daily. We have an opportunity to make our lives healthier and longer by putting this new knowledge to use. Indeed, many Americans are already doing so, as indicated by the latest estimate that 100 million of us are taking vitamins on a regular basis. And Americans in record numbers are seeking out complementary approaches to medical care, be they nutritional counseling, chiropractic, acupuncture, stress-management techniques, or other avenues to health. When I travel the country on lecture tours, I get a sense that the people are hungry for ways to go beyond what the medical establishment has to offer.

This is not to say that the traditional medical establishment has nothing of value to offer. It has brought us many lifesaving innovations, including emergency and post-trauma care and, yes, drugs. Antibiotics, for instance, have been miracle medicines, and it’s not the fault of the developers of antibiotics that they’ve been so overprescribed that antibiotic-resistant bacterial strains have now developed. The problem with mainstream medicine is that it hasn’t been good at dealing with the chronic conditions plaguing us today, such as cancer, heart disease, arthritis, and depression, The magic-bullet approach that orthodox medicine is geared to just doesn’t work with these – because, first, magic bullets tend to have side effects, and, second, to really make a dent in these chronic conditions, you have to make lifestyle changes.

That’s what the challenge we face today is about. We finally want to make lifestyle changes. We finally want to give natural supplements a real try because we’re learning more about what they can do. But there are forces now that are trying to prevent us from freely choosing these alternatives. Our challenge is to educate ourselves about those who would lay siege to our freedom of choice, and then figure out how to counter them.

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