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Archive #4
8/97 - 10/97


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Seven States Sue to Halt Herbal Ecstacy Sales

Seven states have sued to end the sale of the Global World Media Corporation product "Herbal Ecstacy". Classed as a dietary supplement, the product contains Ma Huang, a source of natural ephedrine. The FDA has linked ephedrine-laced dietary supplements to at least 17 deaths and 800 illnesses. Herbal Ecstasy is one of a number of supplements previously banned in Florida after the 1996 death of a 20-year-old student from a similar product, Ultimate Xphoria. In addition to the danger of the product, the lawsuits allege that Global used deceptive trade practices & false advertising, such as testimonials from a made-up doctor & organization. [AP 10/15/96]

Note: On 4/23/96 the N.Y. Times reported that Shayan said he was 20 yrs. old and that his company had sold $300 million worth of Herbal Exstacy pills in four years.

Four Deaths Linked to Aloe Vera Quackery

Virginia authorities are investigating the deaths of four cancer patients allegedly treated with aloe vera by Manassas orthopedic surgeon Donald L. MacNay. The aloe vera product, known as "T-UP", was obtained from the Baltimore offices of Allen Hoffman and Neal Deoul, who promoted its use for numerous diseases including AIDS, cancer, lupus, diabetes, multiple sclerosis, arthritis, herpes, pneumonia and emphysema. Promotional literature put out by Hoffman and Deoul described dramatic cancer and AIDS cures with 50% cure rates.

Although injection of aloe vera is illegal in the United States, three of the victims reportedly received the aloe vera intravenously, Although Hoffman and Deoul deny promoting the intravenous use of their product within the U.S., they acknowledge recommending the transportation of patients to countries for IV administration or injection directly into tumors. The Washington Post obtained a bottle with a T-UP label which was rubber-stoppered, sealed, and labeled in the manner commonly used for injectable substances. A number of U.S. doctors have said that Hoffman offered to sell them solutions for intravenous administration.

Wisconsin Nabs Ginseng Growers

Wisconsin agriculture officials have uncovered widespread use of illegal pesticides on ginseng crops. Growers were apparently ignoring prohibitive warnings on the product labels of the pesticide lindane and the fungicide PCNB. About 90 percent of the U.S. ginseng crop is grown is Wisconsin, and is prized for it's alleged purity. [AOL News 10/5/97]

FDA Publishes Final Dietary Supplement Rules

The FDA has published final rules to implement the supplement labeling requirements of the Dietary Supplement Health and Education Act of 1994. Products containing ingredients such as vitamins, minerals, herbs or amino acids must be labeled as dietary supplements and must bear a "Supplement Facts" panel with information similar to the "Nutrition Facts" panels that appear on most processed foods. The new FDA rules also set parameters for use of the terms "high potency" and "antioxidant" when used in the labeling of dietary supplements and requires the labels of products containing botanical ingredients to identify the part of the plant used to make products. [FDA Press Release 9/23/97]

Fake Nebraska Doctor Pleads Guilty to Fraud

Edwin Kokes, of Grand Island, has pled guilty to charges of mail fraud for posing as a doctor. Kokes advertised that he could diagnose diseases using a "laser" and hair or fingernail samples, and claimed to have cured 500 AIDS and cancer patients. One treatment sold by Kokes for up to $300 per ounce, known as "M-Bone" , was actually diluted sulfuric acid. Kokes could face up to five years in prison and a $250,000 fine. [AP 9/23/97]

NIH Quack Medicine Office May Become a Center

"The Harkin amendment to elevate the NIH Office of Alternative Medicine to a National Center was dropped from the FDA bill (S 3.80) with agreement that hearings would be held on the measure in early October." "Not content to fatten its budget, Sen. Harkin wants to turn the Office of Alternative Medicine into the National Center of Complementary and Alternative Medicine, greatly increasing its visibility and budget."

"Sen. Barbara Mikulski (D-MD), a cosponsor, said that some years ago she had very serious illnesses for which "Western medicine was of limited utility"; acupuncture helped her get well. She did not indicate what sort of control group she used in her study. The measure calls for an advisory council for the Center that would include at least one practitioner from each alternative therapy. They may have to meet in the Superdome."[APS WhatsNew 9/19/97 and 9/26/97]

Kathy Guccione Dies Despite Hydrazine "Cure"

Kathy Keeton Guccione, president and chief operating officer of General Media International, died of cancer on Friday September xx at age 58. She was the wife of Bob Guccione, founder and publisher of Penthouse magazine.

Ms. Guccione was diagnosed with late stage IV breast cancer in May 1995. She subsequently made numerous media appearances saying that she had been given only three weeks to live but had been successfully treated with hydrazine sulfate. A few weeks before her death, she appeared on the Art Bell show claiming to be cancer free as a result of the hydrazine treatments. She died during surgery to remove cancerous tumors impacting her upper digestive system.

According to information from the American Council on Science and Health, the 5-year relative survival ratio for metastatic breast cancer is about 20% and the 10-year relative survival ratio for metastatic breast cancer is about 10%.

FDA Withdraws Flenfluramine and Dexfenfluramine

"The Food and Drug Administration, acting on new evidence about significant side-effects associated with fenfluramine and dexfenfluramine, has asked the manufacturers to voluntarily withdraw both treatments for obesity from the market. Dexfenfluramine is manufactured for Interneuron Pharmaceuticals and marketed under the name of Redux by Wyeth-Ayerst Laboratories, a subsidiary of American Home Products Corp. of Madison, N.J., which also manufactures and markets fenfluramine under the brand name Pondimin. Both companies have agreed to voluntarily withdraw their drugs.

"The FDA is not requesting the withdrawal of phentermine, the third widely used medication for obesity. The action is based on new findings from doctors who have evaluated patients taking these two drugs with echocardiograms, a special procedure that can test the functioning of heart valves. These findings indicate that approximately 30 percent of patients who were evaluated had abnormal echocardiograms, even though they had no symptoms. This is a much higher than expected percentage of abnormal test results. 'These findings call for prompt action,' said Michael A. Friedman, M.D., the Lead Deputy Commissioner of the FDA. 'The data we have obtained indicate that fenfluramine, and the chemically closely related dexfenfluramine, present an unacceptable risk at this time to patients who take them.'

"FDA recommends that patients using either of these products stop taking them. Users of these two products should contact their doctors to discuss their treatment. These new findings suggest fenfluramine and dexfenfluramine are the likely cause of heart valve problems of the type that prompted FDA=s two earlier warnings concerning 'fen-phen', a combination of fenfluramine and phentermine. 'Fen-phen' has been widely used off-label in recent years for the long-term management of obesity. In July, researchers at the Mayo Clinic and Mayo Foundation reported 24 cases of rare valvular disease in women who took the 'fen-phen' combination therapy. FDA alerted medical doctors that it had received nine additional reports of the same type, and requested all health care professionals to report any such cases to the agency's MedWatch program (1-800-FDA-1088/fax 1-800-FDA-0178) or to the respective pharmaceutical manufacturers. Subsequently, FDA received 66 additional reports of heart valve disease associated mainly with 'fen-phen.' There were also reports of cases seen in patients taking only fenfluramine or dexfenfluramine. FDA requested that the manufacturers of fenfluramine and dexfenfluramine stress the potential risk to the heart in the drugs' labeling and patient package inserts. FDA continues to receive reports of cardiac valvular disease in persons who have taken these drugs."

2 Big HMOs May Offer Alternative Health Care

Blue Shield of California and Health Net have followed Kaiser Permanente in asking the state of California to approve direct access for their members to alternative and traditionally Eastern medical care such as acpuncture. Health Net hopes to hire 700 acupuncturists to treat conditions including arthritis, AIDS, and side effects of chemotherapy. Both HMOs will retain approximately 700 chiropractors. [San Jose Mercury News 9/10/97]

Nutrition Tops $17 Billion Per Year

Nutrition Business International places the size of the US nutrition industry at $17.2 billion annually, as follows:
  • Dietary supplements - 52% / $8.9 billion
  • Natural foods and beverages - 36% / $6.2 billion
  • Natural personal care and beauty products - 12% / $2 billion
[Alternative Medicine Digest, Issue 19]

World Athletic Champ Fails Ephedrine Test

Yet another athletic champion has failed testing for ephedrine use as a result of dietary "supplements" aimed at the sports market.

Ukrainian shot putter Aleksandr Bagach was recently stripped of his gold medal and $60,000 in prize money after testing positive for a banned substance at the World Championships. He blamed the test result on his use of a product called "Quick Energy" and wants compensation from the manufacturer, Universal Nutrition. Although the "all natural" product label did not specify ephedrine as an ingredient, the supplement contained mahuang which contains ephedrine and pseudoephedrine. The product is advertised in Kiev as the "No. 1 choice among top athletes."

[Track and Field, 8/14/97]

Florida Bans Solar Ray, Stacker 2 and Generation X

Following the recent death of a college student, Florida has outlawed the ephedrine-containing herbal products Solar Ray, Stacker 2 and Generation X. These products exceeded guidelines for stimulants in products sold over the counter. Herbal ephedrine is often marketed with claims that it heightens sexual awareness and improves athletic performance. So far, the FDA is aware of at least 15 deaths associated with ephedrine in "nutritional supplements." [AP 8/13/97]

FDA Warns of Steroids in "Skin-Cap"

The FDA has issued a warning regarding the commercial product called "Skin-Cap" If anyone is using this product, they should contact a doctor immediately. This product, used primarily by psoriasis patients, secretly contains powerful steroids that can produce side effects. Because an abrupt halt to the use of the medication could cause a life-threatening flare-up of the disease, patients should not stop treatment without a doctor's help.

The FDA also told U.S. Customs to detain all imports of the product.

FDA Warns Against Stimulator Pain Device

The U.S. Food and Drug Administration (FDA) has issued a warning to manufacturers of the "Stimulator" device that the product unapproved. Allegedly a pain control device, the Stimulator was described by FDA officials as "essentially an electric gas barbecue grill igniter outfitted with finger grips." "When pressed against the skin, the Stimulator sparks and causes a small electric shock. Makers of the device claim it can relieve headaches, back pain, arthritis, stress, menstrual cramps, earaches, sinus, nosebleeds, flu and other ailments."

Makers of the device had not obtained appropriate FDA approval, and had not submitted information demonstrating the device is safe or effective. The FDA obtained The FDA said it had gotten a court injunction against Universal Management Services Inc. and Natural Choice Inc. of Akron, Ohio, to stop advertising, sales and distribution of the device. "In addition, over the past three years FDA has sent warning letters to six companies about the marketing of this device," the statement added. The FDA said makers had recently told customers that the agency had seized checks from customers who had ordered but not received the device. It said this was untrue and it had told the U.S. District Court in eastern Ohio. It named the six firms that received warning letters as Natural Innovations of Canton, Ohio, Gandee Chiropractic Life Center of Akron, Self-Care of Emeryville, California, Magna Plus Inc of Twinsburg, Ohio, Bright Marketing of Burlington, Iowa and Crystaldyne Inc. of Scottsdale, Arizona. [FDA Press Release 8/28/97]

Biologists Call for Elimination of Office of Alternative Medicine

Leading biologists have called for elimination of the NIH Office of Alternative Medicine, charging that it has promoted practices "which clearly violate basic laws of physics and more nearly resemble witchcraft than medicine." OAM Director Wayne Jonas responded in the August issue of Nature: Medicine, justifying research in homeopathy: "Even though this concept is implausible, the potential implications it holds for understanding basic biological and cellular communication are enormous. Can we not afford to invest a small amount in pursuit of this question_"

American Physical Society's Bob Park comments: "I can think of a thousand implausible concepts that would hold enormous implications -- if true. In Germany, a randomized, placebo controlled, double-blind clinical trial of a standard homeopathic remedy found 'no significant difference in any parameter between homeopathy and placebo.' In five years, it has never occurred to OAM to support such a study." [Hawaii Rational Inquirer, 8/4/97]

Corvalol Health Hazard

The FDA is alerting State Health Departments of an imminent health hazard associated with an unapproved drug product imported from Russia known as "Corvalolum" or "Corvalol". This product contains dangerously large amounts of a recognized Class IV Scheduled drug, phenobarbital, as well as an unmarketed controlled substance, alpha-bromideisovaleric acid ethyl ether (bromisovalum). It is illegal to market this product in the United States.

The label for "Corvalolum" or "Corvalol" may be printed in Cyrillic characters used in the Russian alphabet and may not display the English equivalent. The product "Corvalolum" or "Corvalol" will appear as "" and phenobarbital will appear as "". The label fails to provide adequate warnings or directions for use. The preparation is taken in water or with sugar three times a day, 15 to 20 drops each time. The label directs that, if necessary, the dosage can be increased up to 40-50 drops. Laboratory analysis reveals approximately 17 mg/ml of phenobarbital. The dose of phenobarbital (52.2-130.5 mg/day) is such that the individuals who consume these amounts would be placing themselves in a serious health hazard situation. The potential exists for either an inadvertent or intentional overdose or misuse of the product that could lead to a permanent disability or fatality.

FDA is aware of the product being sold Over the Counter (OTC) in Russian and Polish communities. Neither phenobarbital nor bromisovalum are approved for OTC use in the US. The product is brought into this country in tourists' baggage under the Personal Importation provisions and identified as a "Russian heart medication." In January of this year, one tourist entered the country with 27 package of 60 bottles each totaling 11 gallons.

Since the use of "Corvalolum" or "Corvalol" is an imminent health hazard, we are asking your assistance in providing this information to appropriate individuals in your state and in removing the product from the market in the United States. If you need further assistance,

OAM: Scientists Launch an Attack

"APS President D. Allan Bromley joined leading biologists last week in calling for elimination of the NIH Office of Alternative Medicine. In a letter to John Porter (R-IL), HHS Appropriations Subcommittee chair, Bromley charged that the OAM has promoted practices "which clearly violate basic laws of physics and more nearly resemble witchcraft than medicine." The Subcommittee decided to cut the OAM budget to $7.5M, from its current $12.5M, in keeping with the President's request. That sets up a fight with the Senate, where the OAM originated in 1992 as an earmark."[APS What's New 7/18/97]

Company Settles Over `Herbal Ecstasy' Claims

The maker of Herbal Ecstasy has settled FTC false advertising charges by agreeing to include warnings on its label about potential health risks such as damage to the heart and central nervous system, and to ensure that future claims regarding safety of the product be backed by scientific research. The FTC had alleged that ads purchased extolling the diet supplement's "natural high" and portraying it as "100 percent natural and absolutely safe" diet supplement were false. The agency also alleged that a fictitious doctor was used in product ads to endorse the supplement and comment about its supposed lack of side effects. According to the settlement with the stimulant's manufacturer, Global World Media Corp., and its owner, Sean Shayan, any safety claims in all future advertisements must be supported by scientific evidence. Warnings about possible side effects also must also appear in the ads, as well as product labels, the FTC said. "Despite evidence of those health risks and at least one death of a college student in Florida, which was directly attributed to taking a large dose of a product similar to Ecstasy, the company continued to promote this product as a safe and natural high and has encouraged the young people who buy Ecstasy to take exceedingly high doses," said Jodie Bernstein of the FTC's consumer protection bureau. The main ingredient of Herbal Ecstasy is ephedra, a compound extracted from plants and used for centuries by Chinese practitioners as a medicine. Ephedra also is sold under the names Ma huang, Chinese ephedra and epitonin.

The FDA recently proposed cracking down on the marketing of Herbal Ecstasy and other ephedra products, citing about 800 injuries and at least 17 deaths linked to the herbal stimulant. Among the proposals are limiting concentrations of the herb in any dietary supplement, requiring warning labels that its use can cause death and banning claims that it can help people lose weight or build muscle. [Washington Post, 7/13/97]

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