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NCRHI News, May/June 1998

Volume 21, Issue #3

WATCH OUT FOR KAVA

Kava root extract is a traditional drink use in the South Pacific for religious ceremonies and to get "mellow." Kava drinks are used much as are alcoholic beverages elsewhere. In small doses, kava reduces anxiety, relaxes muscles, and numbs the mouth when chewed. Large doses are intoxicating, causing drowsiness, nausea, muscle weakness, and blurred vision. Chronic use can cause reddened eyes and a yellow skin discoloration (as plant pigments accumulate) with dryness and flakiness.

Kava should not be combined with alcohol or other central nervous system depressants. People should not drive cars or operate machinery under the influence of kava. The problem is that kava is being promoted as an alternative to Valium or Xanax for anxiety or stress. Without the legal restrictions or general knowledge of its effects, kava is a time-bomb that will surely explode at some future time. Truck drivers, airline pilots, railroad engineers, bus drivers, taxi drivers, and many others whose altered reflexes and judgment could lead to tragedy can get kava in health food and drug stores at will. In the 1970s, kava was sold as a "street drug" through the counterculture publications. Hey, man, its everywhere now! No more sneakin' around! You dig? Cool, baby!

[The Pharmacist's Letter, 4/98; The Lawrence Review of Natural Products, 11/96; Pacific Information on Street Drugs, 5/77]

RIPPED FUEL LINKED TO TWO DEATHS IN CALIFORNIA

NCAHF has learned of two recent deaths that are blamed on the dietary supplement Ripped Fuel.

Ripped Fuel is manufactured by Twin Laboratories, Inc., of Ronkonkoma, NY. As its name implies, Ripped Fuel is sold as an athletic performance enhancer (aka ergogenic aid) and for weight loss. NCAHF has been told that Ripped Fuel is available in two different formulations. The original is sold in states where ephedrine is legal and the other formulation is for states where it is not. The original formulation contained ephedrine, kola, L-carnitine, and chromium picolinate. The recommended dose of 6 capsules per day (2 at each mealtime) would contain 60 mg ephedrine, 300 mg of caffeine (from kola), 300 mg of L-carnitine (a metabolite which is synthesized in the liver from lysine and methionine alleged, but unproven, to speed up the burning of body fat, and 600 mg chromium picolinate. The alternate formula eliminates the ephedrine, adds the amino acid phenylalanine, replaces the kola with guarana. Guarana has a relatively high caffeine content, ranging from 2.5% to 5% and averaging about 3.5%.

An article in Muscular Development magazine published by Twin Labs, says that people shouldn't take caffeine before workouts because it raises blood pressure. This is strange because Ripped Fuel's label says to take it before workouts. Yet, its recommended daily dose has 900 mg caffeine (the equivalent to 6-8 cups of brewed coffee or 8-22 cups of instant coffee). California permits the marketing of the ephedrine-containing formula. The LA Times quotes the owner of the Cloud Nine Shoppe in Moodus, Connecticut as saying that "the ephedrine-free products aren't nearly as good. There's no comparison. You hardly get anything out of them."

[Chawkins. "Death of 15-year-old fuels concern over energy pills," Los Angeles Times, 4/16/98:A3+]

(Note. Another Ripped Fuel related death has been reported in Minnesota, but we have no details.)

CHIROPRACTOR NOT LIABLE FOR
FAILURE TO WARN OF ABNORMAL MASS

On April 21, a Wisconsin appellate court ruled that chiropractor Mark Murray was not liable for Gerald Pilak's death from lung cancer because, unlike physicians, chiropractors are not licensed to diagnose medical problems.

According to court records, Pilak sought Murray's services for neck, shoulder and back pain in 1992. Murray X-rayed Pilak and told him that the radiographs indicated that he needed a spinal adjustment. The X-ray also showed an abnormal mass near his spine that later was found to be cancer. Pilak died in 1994 at age 57. Pilak's family sued Murray for failing to point out the abnormal mass to Pilak. Doing so would have enabled Pilak to obtain earlier diagnosis and treatment which would have increased his chances of survival.

However, now that they were in court, the plaintiffs ran smack into the letter of the law. The court stated that in Wisconsin chiropractors are limited to treating the spinal column and adjacent tissues. This does not include the lungs. The Pilak family attorney argued that if a chiropractor is trained to recognize what is normal on an X-ray, he should be able to recognize an abnormality and at least inform a patient about it so medical help can be sought. Murray's attorney and the court disagreed.

[AP. "Chiropractor not liable for lung cancer death," Kenosha News, 4/22/98]

Comment. X-rays can show that a spine should NOT be manipulated, they cannot show that an "adjustment" is needed. Chiros do not need a reason to render a spinal "adjustment." NCAHF board chairman Charles DuVall, DC, says "When the only tool one has is a hammer, everything looks like a nail!."

It is ironic that chiropractors are permitted to call themselves "physicians" in some states, and to foster the illusion that they are suitable primary health-care providers by training. But, when chiros are taken to court for malpractice, they fall back on the legal doctrine that puts the patient at his/her own risk. MDs who testify that the chiro failed to provide competent medical care are of little help because chiros are not held to medical standards of conduct. Chiros only have to show that they behaved as chiros. To properly inform the public, the state should require signs to be placed in chiros' offices informing citizens of the limitations of these licensed providers.

WHEN GOVERNMENT GETS IN BED WITH
PSEUDOSCIENCE, THINGS CAN GET KNOTTY

The U.S. Dept of Agriculture (USDA) is retreating from proposals on "organic food" standards that would have allowed the use of irradiation, sewage sludge and bioengineered material (eg, genetically altered seeds to improve yield).

According to Reuters News Service, 200,000 angry letters, Willie Nelson, and 48 members of Congress joined organic farmers in attacking the USDA's proposals. Never mind that the methods are safe, they are considered "inappropriate." The straight truth is that "organic foods" are indistinguishable from conventional foods after they have been grown.

When Congress passed the U.S. Organic Foods Production Act of 1990, it was pandering to the ignorance-induced anxiety of a neurotic segment of society worried about "chemicals" in their food. Never mind that modern agriculture and food technology are essential for feeding the growing population, and that part of population growth is attributable to the longevity revolution currently taking place around the world which is itself due to advances in science and technology. The Congress should be advancing rational science, not pandering to emotional food symbolism. In political language, it is a time to lead, not a time to follow.

Recommended Reading: Barrett S. "The truth about organic 'certification'; does it help ensure safer foods--or just costlier ones?" Nutrition Forum, Mar-Apr, '98.

CHOLESTIN "SUPPLEMENT" RULED TO BE A "DRUG"

Cholestin is a variety of red yeast, Monascus purpureus, derived from fermented rice. It contains lovastatin, the same active ingredient found in Merck's prescription drug, Mevacor, which is one of a group of "statin" drugs used to lower cholesterol.

After months of wrangling over the contradiction of allowing the marketing of an over-the-counter product that is indistinguishable from a prescription medication, on May 20, the FDA banned Cholestin as an OTC product. The manufacturer, Pharmanex of Simi Valley, Calif, has vowed to challenge the ban in court. A hearing has been scheduled for June 15. This court's decision is apt to have far-reaching effects by helping establish the limitations of the 1994 Dietary Supplements Health & Education Act.

[Sources: "The nondrug drug that lowers your cholesterol," UCB Wellness Letter, April, 1998; Reuters. "FDA bans Cholestin," May 20, 1998]

BURZYNSKI ANNOUNCES INTERIM RESULTS

A Burzynski Research Institute (BRI) company press release announced on May 24 that its Antineoplastons A10 and AS2-1, used in combination, produced either complete tumor elimination or greater than 50% reduction in tumor size in 43 of 178 patients (24.1%). An additional 72 patients (40.5%) experienced stable disease, meaning that their tumors did not progress or shrink more than 50%. The two largest groups of patients suffered either from glioblastoma multiforme (36.5%) or astrocytoma-type tumors (32%). These results are exciting, the report said, because conventional treatments are generally considered ineffective against such tumors. BRI now believes it has enough data to apply for FDA approval.

Comment. The study was forced on BRI by the government as part of an action taken more than two years ago. It will be interesting to see how other researchers respond to the BRI data. Information on brain tumors from the National Cancer Institute does not agree with the BRI statement that conventional therapy is ineffective [PDQ State-of-the-Art Cancer Treatment Summary for Health Professionals: Childhood cerebral astrocytoma, 7/97]. It can also be asked if the nature of the BRI produces any kind of a selection effect of the type of patients that are enrolled. For instance, does the travel and effort involved eliminate sicker patients in favor of those who may be surviving longer due to the nature of their diseases? There is also the matter of replication by another cancer research facility that doesn't have the emotional or financial self-interest of BRI. At this point, we can only hope that an effective treatment for brain tumors has been found. If it has, it will be a shame that it took action by the government, and so much time to get the testing done.

DUBIOUS CANCER CURE FUELS ITALIAN POLITICAL STRIFE

An 85-yr-old physician, Luigi Di Bella, promotes a cancer cocktail containing a mixture of vitamins, minerals, and the drug somatostatin. Somatostatin has been shown to have some effect on some rare neuroendocrine tumors, but not others. Di Bella, however, claims to have cured thousands of patients.

Di Bella's supporters have joined forces with a right-wing political party, Alleanza Nazionale against the Italian Medical establishment. Those who demand medical evidence are being branded as "left wing" by the Di Bellans. The arguments and tactics sound very familiar to veterans of the Laetrile wars of the 1970s in the USA.

In January, the Italian Minister of Health, Rosa Bindi, ordered Di Bella to submit his files for review. Di Bella refused, claiming that he could not expect a fair evaluation. Di Bella's supporters also rejected Bindi's offer to assemble an international panel of independent experts to evaluate Di Bella's data. Bindi has decided to spend $11 million US to conduct 10 clinical trials of the cocktail. Critics lament that the expenditure has not been properly justified by an expert review, and that such a large expenditure could do much more if applied to other public health problems. [Nature, 4/2/98]

VITAMIN C PRO-OXIDANT

Researchers at the UK's University of Leicester found in a 6-week study of 30 healthy men and women that a daily 500 mg vitamin C pill had pro-oxidant as well as antioxidant effects on DNA The vitamin C promoted genetic damage to the adenine bases of DNA that had not been previously measured (adenine to oxoadenine). The vitamin did protect the guanine bases (oxidation of guanine to oxoguanine). Researchers question the current promotion of vitamin C as an antioxidant based upon their findings. [Podmore, et al. "Vitamin C exhibits pro-oxidant properties," Nature, 1998;392:559]

Comment. Dr. Victor Herbert has been telling all who would listen this very thing for years. NCAHF has carried Herbert's message because he is experienced in the laboratory and clinical work of nutrition and biochemistry.

USEFUL ARTICLE ON PATIENTS' USE OF HERBAL REMEDIES

Consultation-liaison psychiatrists discuss the use of herbal remedies by patients who are struggling with the physical and emotional effects of acute or chronic disease, and have become disillusioned with conventional medical treatments and their health care providers. Such patients are prone to use alternative approaches to regain a sense of control or hope regarding their illnesses. This does not mean that they have become New Age devotees. Nearly all combine alternatives with their conventional medical care rather than abandoning the latter.

This article focuses upon the risks of herbal remedy use rather than the behavioral aspects of the problem. The authors point out that both patients and physicians are apt to be ignorant of the true nature of herbal remedies. Such products are neither inactive placebos, benign, or without any therapeutic worth. On the contrary. Because of the potential for side effects, toxic reactions, and unwanted herb/drug interactions, physicians need to learn about the herbal medicines being used by their patients. The authors go on to supply a great deal of useful information on a number of popular herbal remedies.

[Crone CC, Wide TN. "Use of herbal medicines among consultation-liaison populations," Psychosomatics, 1998;39:3-13]

WIDESPREAD MISCONCEPTIONS ABOUT THE
CAUSES OF CANCER COST SOCIETY BILLIONS

Molecular biologists Bruce Ames and Lois Gold, of the Carcinogenic Potency Project at the National Institute of Environmental Health Sciences Center at the University of California, Berkeley, teamed up to debunk major misconceptions concerning the role of synthetic chemical pollutants as causes of cancer. Ames and Gold tackle nine major misconceptions:

  1. Cancer rates are soaring.
  2. Synthetic chemicals in the environment are an important cause of human cancer.
  3. Reducing pesticide residues is an effective way to prevent diet-related cancer.
  4. Human exposures to carcinogens and other potential hazards are primarily to synthetic chemicals.
  5. Cancer risks to humans can be assessed by standard high-dose animal cancer tests.
  6. Synthetic chemicals pose greater carcinogenic hazards than natural chemicals.
  7. The toxicology of synthetic chemicals is different from that of natural chemicals.
  8. Pesticides and other synthetic chemicals are disrupting human hormones.
  9. Regulating low, hypothetical risks advances public health.

Ames and Gold point out that regulations targeted to eliminate minuscle levels of synthetic chemicals cost society an estimated $140 billion per year. Attempting to reduce synthetic pesticides may make fruits and vegetables more expensive thereby decreasing their consumption and increasing cancer rates. A re-examination of priorities in cancer prevention is called for.

[Ames B, Gold LS. "Environmental pollution, pesticides, and the prevention of cancer: misconceptions," FASEB J 1997;11:1041-52]

Comment. By tackling these misconceptions, Ames and Gold strike at the heart of the misinformation that furthers the interests of the health food industry, the organic food movement, herbology, renegade medicine, and others that profit from ignorance and misguided ideologies. The problem is that these notions are rooted in a basic fear of science which is as old as the legend about the fall of man being caused by eating of the Tree of Knowledge in the Garden of Eden. The human fear of science and technology has been reinforced by the literary notion of the "mad scientist" furthered by the story of Dr. Frankenstein (Mary Shelly, 1828), Dr. Jekyll and Mr. Hyde (1886), and the sinking of the Titanic. The Titanic was named for a group of lesser gods, the Titans, who dared to challenged the supremacy of Apollo. Apollo destroyed them for their arrogance. Thus, the Titanic disaster has become symbolic of human arrogance and the folly of human knowledge. The Bible also mocks the "wisdom of the world" in I Corinthians 1:20. Curiously, in that instance, the Apostle Paul was demeaning Greek mythology!

SURVEY ON WHY PATIENTS USE ALTERNATIVE MEDICINE

A researcher at the Stanford Center for Research in Disease Prevention set out to investigate possible predictors of alternative health care use. Three primary hypotheses were tested: (1) they are dissatisfied in some way with conventional treatment; (2) they see alternative treatments as offering more personal autonomy and control over health care decisions; and, (3) the alternatives are seen as more compatible with the patient's values, worldview, or beliefs regarding the nature and meaning of health and illness.

A written survey was completed by 1,035 of 1,500 people randomly selected (69% response rate) from a nationally representative panel of persons who have agreed to participate in mail surveys for National Family Opinions, Inc.. The sample was slightly under-representative of younger, less educated, and poorer persons. Asked to list their top 3 most "bothersome" or "serious" health problems, the top 5 reported were: (1) back problems (19.7%); (2) allergies (16.6%); (3) sprains/muscle strains; (4) digestive problems (14.5%); and, (5) lung problems, pneumonia, or respiratory infections (13%). The top 4 treatment categories used were: (1) chiropractic (15.7%); (2) lifestyle diet (8.0%); (3) exercise/movement (7.2%); and (4) relaxation (6.9%).

The most frequently-cited health problems treated with alternative therapies were: (1) chronic pain (37%); (2) anxiety, chronic fatigue syndrome, and "other health condition" (31% each); (3) sprains/muscle strains (26%); (4) addictive problems and arthritis (both 25%); and, (5) headaches (24%). Only 4.4% of the sample relied primarily upon alternative health care.

Conclusion. Along with being more educated and reporting poorer health status, the majority of alternative medicine users appear to be doing so not so much as a result of being dissatisfied with conventional medicine but largely because they find these health care alternatives congruent with their own values, beliefs, and philosophical orientations toward health and life.

[Astin JA, "Why patients use alternative medicine," JAMA, 1998;279:1548-53].

Comment. The study seemed geared to draw out congruence with expressions of holistic philosophy and self-descriptions representative of "cultural creatives" identified by Ray (see NCAHF Newsletter, Jan-Feb, 1997:3) which were presented in such a positive manner that many would find something with which they could identify. As a result, the study appears to overestimate the proportion of the population who use alternative medicine on the basis of philosophical congruence.

CHITOSAN

Chitin is a cellulose-like biopolymer found in the exoskeletons of marine creatures such as shrimp, crabs, and lobsters. The processing of squid in New Zealand provides an inexpensive source of chitin as a waste by-product. Deacylated chitin is called chitosan. Chitosan is unique in that, unlike plant cellulose that is negatively charged, it possesses positively charged amino groups that bind to negatively charged lipid and bile components. It can bind 4 to 6 times its weight in greases, oils and toxic substances and has been used in water purification plants for about 30 years for such purposes. Chitosan has also been used in the pharmaceutical and cosmetic industries for a variety of purposes.

The substance has recently been promoted as a weight loss agent based upon its ability to absorb fatty acids and bile in the gut to prevent their uptake. Although a review of the literature did not mention weight loss due to chitosan, a cholesterol-reducing effect is mentioned. People with shellfish allergy and women who are pregnant are warned to check with their doctors before using. The chemical composition of chitosans varies, which may affect its toxicity.

[Lawrence Review of Natural Products, 3/98]

DEATH OF A NUTRITION ENTHUSIAST

Anne Frahm's breast cancer was widely disseminated by the time it was diagnosed. She underwent surgery, chemotherapy, radiation, and hormone therapy. When these failed to send her disease into remission, she underwent an experimental autologous bone marrow transplant. She was then told that there was nothing else that could be done. Five weeks later, her disease was in total remission.

Curiously, Frahm did not credit the biological effects of the bone marrow transplant with her recovery. Rather, she credited having adopted an extreme regimen of enemas (to "detoxify"), two weeks of juicing, eating raw fruits and vegetables, and avoiding sugar, meat, and dairy products. She got the idea that these dietary practices from searching the books that are most readily available in the marketplace. What Anne didn't realize is that most popular books about cancer are not reliable. The "authorities" Frahm names in her book, A Cancer Battle Plan, reads like a list of "who's who" in the world of cancer quackery.

A religious person, Anne seemed confused about whether to give God or bizarre nutrition and self-treatment practices credit for her good fortune. She opted to claim that God works through these extreme lifestyle practices, His wonders to perform. She and her husband started HealthQuarters ministry located in Colorado Springs and began teaching others to practice extreme nutrition and self-care. Her Colorado Springs location exposed her to another source of misinformation, Ex-DDS Hal Huggins, and his local network of renegade health care providers. This appears to be significant in the final chapter of her life.

Stories such as those of Anne's are very, very sad. We all are sympathetic to cancer patients whose lives are upset in their primes. Their focus shifts from family and career to battling the specter of an early death. However, those who have the audacity to declare that the nutrition scientists are wrong about how we should eat, and who gives so little credit to the medical scientists who are working so hard at understanding cancer prevention and treatment, assumes a heavy burden when they themselves fail to live out a full life.

Just as the Anne Frahm's of the world want people to believe in their programs based upon their own personal survival, they should be willing to have their personal failures stand as equal evidence of their folly. Poor Anne died in February. The surviving true believers say that although the cancer had recurred, Anne actually died of a "cavitation"--a dental infection of the kind Hal Huggins and others are blaming on root canals (see "Outmoded dental infection theory trying a comeback," NCAHF Newsletter, May-June, 1994).

Anne was driven by fear and victimized by her ignorance. She was beguiled by the self-styled prophets of health who disdain the scientific approach to solving the mysteries of disease. Instead they turn to ideologies such as natural hygiene, vegetarianism, anti-establishmentarianism, and the confusion of mixing the idea "God worked a miracle," with their own notions about how to "cure yourself." HealthQuarters apparently plans to continue on its mission of promoting Anne's program. This calls to mind a seasoned observation about "true believers":

Failures never daunt them. They can be rationalized. The technique was not properly applied. And, even when things turned out badly, they relieve themselves by believing that things would have undoubtedly been worse if they had not applied the technique. This is blind faith.

Anne Frahm's case is a classic example of how good intentions combined with medical ignorance, and especially of the dynamics of self-deception via personal experience, can create an anathema for society. Frahm's misconceptions about how to deal with cancer demonstrate an essential principle of folk medicine: folk practitioners are "experts" in what "everyone knows" (actually, what everyone thinks is true which is a mixture of truth, half-truth, and errora) about health and disease. (See the article by Ames & Gold on cancer misconceptions described elsewhere in this issue.)

There is little difference between the mind-set of practitioners and patients. On the other hand, the gap between medical knowledge and the patient is enormous. In fact, the gap between cancer specialists and general practitioners is also huge and can cause the latter to fall into quackery as well. What chance do the medically-ignorant have if even physicians can be fooled by personal experience coupled with wishful thinking? The wise know their limitations.

BUSINESSES THAT SUE COMPETITORS MAKING:
FALSE CLAIMS FOR UNFAIR COMPETITION
A Useful Antiquackery Tool

The Upjohn Company sued the promoters of the Helsinki Hair Formula after Rogaine was approved by the FDA. It was not willing to share the hair restoration market with a pretender after it had spent millions of dollars proving its product. NCAHF has always liked the idea of legitimate businesses that are willing to take a stand for proven products by challenging competitors with unfair competition for making false claims. We have learned of more recent cases.

Warner-Lambert Company versus Breath Asure Inc. The Warner-Lambert Company, makers of breath fresher products Listerine Antiseptic, Certs, Clorets, and Dentyne, have filed a lawsuit that alleges false advertising violations against Breath Asure, Inc., which sells Breath Asure. In this action Warner-Lambert seeks to stop Breath Asure's false claims that bad breath originates in the stomach, that Breath Asure can attack it there, that the effects will last for hours, and more (the suit names 10 specific false statements). Before leaving this story it is worthy of note that Warner-Lambert has had problems with the FTC for false claims, but the company has complied with corrective measures and tries to stay out of trouble. This being the case, it has even more reason to police the false claims of its competitors. (Civil Action No.98-1940, U.S. District Court, District of New Jersey, April 24, 1998)

Power Bar Inc versus Power Balance Company. Power Bar Inc is charging rival Balance Bar Co with false advertising and unfair competition. Power Bar asserts that advertisements for Balance Bar falsely claim that the snacks "Provide access to stored body fat" and "improve workout performance and recovery." In February, Balance Bar agreed to modify its advertising claims as recommended by the National Advertising Division (NAD) of the Better Business Bureau. The NAD said that Balance Bar lacked sufficient testing to substantiate claims that the zone diet, on which the bar is nutritionally based, is effective. The NAD action resulted from a complaint filed by Power Bar and Mars, Inc., maker of the VO2Max bar.

Pfizer versus Viagra Counterfeits. Publicity on the approval of Pfizer Inc.'s Viagra, an anti-impotency drug that enables penile function by relaxing smooth muscle, has caused an increase in the promotion of many worthless products. Pfizer acted quickly against two substances being promoted on the Internet called Viagro and Vaegra charging copyright violations. Named in a Wall Street Journal article, "Get ready for the Viagra wannabes," (April 30, 1998, p.B1+) were an herbal potion called NuMan (Interceuticals, Inc), Cobra Pills (Natural Balance, Inc), LLC's Stamina (HerbaSway Labs).

Legitimate Businesses as Marketplace Watchdogs. Most interesting to NCAHF is the fact that one company is challenging the false claims of another on the basis of unfair competition. The assertions are that not only does such behavior deprive the legitimate company of immediate income by drawing away business, but by undermining consumer confidence in all such products long term income is also affected negatively. It would be good to see more companies take this approach. Imagine what would happen if the legitimate marketers of nonprescription medications would sue the herbal remedy promoters for unfair competition, diverting consumers from legitimate products, and undermining confidence in the over-the-counter medicine business. Why should one group of companies have to do expensive research and development and obtain FDA approval while others are allowed to make unsubstantiated claims? Imagine what would happen if a group of cancer treatment centers sued a clinic that was drawing cancer patients away by unsubstantiated claims of an effective cancer treatment program. This is a potential "check and balance" solution by marketplace forces aimed at a problem the government has had trouble solving because of accusations that it is Big Brother abusing business.


Newsletter contents copyright 1998, National Council Against Health Fraud, Inc.
Items may be reprinted without permission if suitable credit is given.

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