Tuesday, 4 December 2012

HERBALIFE SIDE EFFECTS-1984

Herbalife Criticized at Senate Hearings

Odom Fanning

Opening two days of hearings, Senator William V. Roth, Jr. (R-DE), chairman of the Senate Permanent Subcommittee on Investigations, made it clear that their purpose was not to "get" Herbalife or any other product, but resulted from five months of investigation into weight reduction products and plans of all types. The Subcommittee is authorized to investigate the efficiency and economy of all branches of the government and also has jurisdiction over "all aspects of crime and lawlessness within the U.S. which have impact upon or affect the national health, welfare, or safety."
Roth acknowledged that following announcement of the hearings (held in Washington, D.C., May 14th and 15th), he had received a "very large number of phone calls and letters from individuals who are very satisfied with the Herbalife products, and have lost large amounts of weight." Many of these correspondents, and an estimated 3,000 Herbalife distributors who marched on the second day, were obviously on the defensive. So was the Food and Drug Administration, for, as the senator put it, the purpose of the hearings was "to find out if the public is being adequately protected when it buys and consumes diet products."
In his opening remarks, Roth made a distinction between "miracle pills and creams," tinted sunglasses, plastic ear forms and other "patently fraudulent products" and the very low calorie (VLC) products that can actually produce weight loss but may not be safe. His major concern with the VLC products, he specified, "is with what the Food and Drug Administration is doing and what it is not doing, particularly when serious questions have been raised both within the FDA and outside this agency about the safety of such products....We are dealing with a multi-billion dollar industry which produces items ingested into the human body. Yet the FDA has been reticent to involve itself in low calorie diets. I want to know why, because I think the public deserves to know conclusively about the safety of individual products now in the marketplace."
On the first day Roth's subcommittee heard testimony from scientists and VLC product users, all of whom submitted written statements as well. Most of the scientists favored more regulation of such dietary products; the users were pro and con.
One scientific witness was Judith S. Stern, Sc.D., professor of nutrition and director of the Food Intake Laboratory at the University of California, Davis. She conceded:
The inadequacy of traditional medicine to provide a permanent cure for obesity has given rise to an entire industry of entrepreneurs who claim to be able to relieve the frustrations of the overweight. The ironic tragedy is that most diets work-at least initially-when they are followed. However, fad diets are usually quite restrictive in their food choices, may have unpleasant side effects, and most people cannot follow them for any length of time. In addition, when daily calories are restricted below 1,200, it becomes difficult to satisfy all other nutrient needs.
Dr. Stern also made the distinction between "miracle cures" and VLC products. Products in the former category include the hormone cholecystokinin (CCK), claimed to decrease hunger, and various amino acid pills, said to release growth hormone. Both have been promoted with false claims based on legitimate scientific discoveries that were overgeneralized and misrepresented, she noted.
Debunking claims that grapefruit or grapefruit extract can act in a catalytic manner enhancing breakdown of fat, Dr. Stern described her testimony last year which helped the U.S. Postal Service stop sales of Super Grapefruit Pills by a California company. Noting that these pills contained glucomannan, she reported that in 1980 she had conducted a double-blind study in which the test group received one gram of glucomannan while the control group was given a placebo. Both groups were placed on a behavior modification program. Both groups lost weight, she noted, but there were no statistically significant differences in hunger ratings or weight loss between them.
Dr. Stern also zeroed in on kelp/lecithin/cider vinegar/vitamin B6 combinations found in dietary products since 1974. Iodine-rich kelp is potentially harmful to a small number of individuals in whom high amounts of ingested iodine can cause thyroid trouble. The other three ingredients are worthless, she noted.
Another expert witness was Varro E. Tyler, Ph.D., professor of pharmacognosy (the science of medicines from natural sources) and dean of Purdue University's School of Pharmacy and Pharmacal Sciences. Here is my summary of Dr. Tyler's detailed analysis of various Herbalife products contained in the lengthy packet of written material released by Roth's subcommittee to the press:
  • Slim and Trim Formula #1 (46 cents per day), described in the sales literature "as a balanced protein powder made from natural vegetable soy, casein and whey protein." Tyler said the product is falsely represented in company literature because there is nothing about a protein powder, per se, that will curb the appetite any more than an equivalent amount of protein derived from eating lean meat, nuts, or the like. Further, no protein powder will "cleanse the system" or facilitate "burning excess calories." It will supply needed daily nutrients, but no more effectively than a low-calorie diet, carefully balanced for carbohydrates, minerals, and vitamins-as well as protein.
  • Slim and Trim Formula #2 (21 cents per day), described by the Herbalife organization as a special blend of 14 herbs plus kelp, lecithin, vitamin B6, and cider vinegar designed to cleanse the digestive system and naturally help curb the appetite. Tyler said that, of its many herbal ingredients, none is actually present in sufficient quantity to produce significant physiological effects by itself. But he noted that four ingredients-senna, cascara sagrada, dandelion root, and kelp-might work together to exert a laxative effect in sensitive individuals.
  • Slim and Trim Multivitamin and Multimineral Formula #3 (23 cents per day) is a fairly standard vitamin/mineral preparation with some herbal products added in such tiny amounts that they exert no significant effect. Unless vitamin deficiency was present, Tyler noted, the product would be a complete waste of money.
  • Slim and Trim Linseed Oil Formula #4 (10 cents per day) contains small amounts of linseed oil but has no advantage over less expensive vegetable oils ordinarily used in the kitchen of the average home. (Moreover, as noted by the next witness, the amount found in the formula will be obtained in food consumed in just one balanced meal per day.)
  • Cell-U-Loss (43 cents per day) is described in Herbalife literature as a product designed to attack cellulite, promote circulation, and eliminate excess fluids, is recommended for use with the Slim and Trim formulas. Tyler noted that its tiny amounts of herbs would at most cause a slight diuresis (output of body water), but would have no effect whatsoever on appetite or body fat.
  • Herbal-aloe is said to aid digestion and cleanse the system. Although uncertain of the type of aloe contained in this product-which may be a laxative-Tyler expressed deep concern over two of its other herbal ingredients. Comfrey, he said, is a known carcinogen, shown to produce malignant tumors in the livers of rats when included in their diet. And the active constituent of chapparal, nordihydroguaiaretic acid (NDGA), was removed from the FDA's GRAS (Generally Recognized As Safe) list many years ago after it was shown to cause cysts and kidney damage in rats.
  • N.R.G. (Nature's Raw Guarana) (80 43 cents per day), claimed to increase energy, aid in mental alertness and produce a nutritional lift, is sold in tablets that contain small amounts of granular guarana, the seed of a South American plant known to contain about 5% caffeine. The amount of caffeine in the recommended dose of N.R.G. is about the same as that in a cup of strong coffee-but the presence of caffeine is not revealed in product labeling or literature. Thus, individuals sensitive to caffeine might be unwittingly harmed.
  • Schizandra Plus tablets are said to help combat stress and damage leading to premature aging. Although he suspected that the dosage of its ingredients was too low to exert pharmacological effects, Tyler indicated that tests are needed to determine whether chemicals extracted from schizandra can protect or harm the liver [see NF 2:29].
  • Tang Kuei (50 cents per day), said to help establish menstrual regularity and provide "herbal nutrition" for the whole body, contains dong quai (also known as dang gui and pinyan) and chamomile. These drugs -- used in traditional Chinese medicine -- have not been proved by Western standards. Tyler noted that even if they are effective, the amounts contained in Tang Kuei are far below those used in China. Moreover, under federal law, Schizandra Plus and Tang Kuei are unapproved new drugs that are not legal to sell in the United States.
Overall, Tyler objected that
  • Some Herbalife products may well be toxic, at least to some consumers.
  • Herbalife literature and word-of-mouth recommendations build up false hopes in consumers, most of whom are not able to benefit from the placebo effect.
  • It is particularly deceptive because they lead the public to believe that Herbalife products "contain a lot of wonderful herbs with marvelous health-giving properties when the amounts present in the products are too small to have any significant physiological effects in normal persons.
  • Consumers are thus paying good money for products which have no proven value. 
  •  
Many of the same points were reiterated in an analysis of the various Herbalife formulas by F. Xavier Pi-Sunyer, M.D., associate professor of Medicine, Columbia University College of Physicians and Surgeons, and a division chief at St. Luke's Roosevelt Hospital Center, New York City.
"With very rapid weight loss, and particularly with diets low in carbohydrate, there is an early diuresis, that is, loss of water via the urine. This accounts for much of the weight loss of crash diets and much of this water is reaccumulated when the diet is stopped," said Dr. Pi-Sunyer. "With this water loss, great amounts of sodium, potassium, and chloride are lost, as well as lesser but substantial amounts of calcium, magnesium, and other minerals. These must be replaced. If they are not, the electrical integrity of biological membranes may be lost, and one outcome of this may be cardiac arrhythmias."
Because dieters wish "to get on with it," there may be a tendency to take only the protein preparation, without supplementing it, as sometimes recommended, by a meal to bring the daily intake to at least 800 to 1,000 calories (of which 300 to 400 may be provided by the dietary product). Consumers also may ignore the limited period, say four weeks, recommended by some diet purveyors, and incur added risk by consuming the preparation for a longer time, said Dr. Pi-Sunyer.
He also reported that a colleague, Theodore B. Van Itallie, M.D., had reexamined data of the victims of the liquid protein diets of 1977-1978 and found that "the less fat you are the more dangerous these diets are for you, the more likely you are to lose life-requiring protein, and the more at risk of dying you are. Since these preparations are bought without restriction, many people take them who are not very fat, and these people seem to be particularly at risk."
 
Two of the four laypersons who testified were constituents of Senator Roth's-one for Herbalife, the other against. Patricia Stombaugh, of Smyrna, Delaware, began taking Herbalife in August 1984. "After taking it for two months, losing five pounds and feeling much better," she was asked by friends "for more information about Herbalife." She soon became a distributor. She and her representatives since have sold it to over 300 people. "Herbalife has worked for me and my customers," she told Roth and the subcommittee. "I believe the people who said they felt better using the Herbalife products are stating the facts: their health problems improved through weight loss and sound nutrition. They are not saying that Herbalife is like a medicine that cures a disease. No one I know has ever claimed this."
Another user, Greg Martin, of Dover, Delaware, lost about 13 pounds in three months and "felt better than I had in years," after starting on Herbalife products in September 1984. He and his wife began selling the products in October, eventually building a customer list of 100 with ten distributors. But most of his customers suffered from constipation when using Slim and Trim Formulas, and 10 -15%t had other problems, he reported. One man who had had two previous heart bypass operations was taking Herbalifeline because Martin "understood from the literature that it was good for heart problems. This man became extremely constipated."
Because he was unable to get answers to his questions from Herbalife headquarters, Martin stopped selling its products to retail customers at the end of February. "I do not want to be associated with a company who claims its products are safe for everyone to use and then will not deal with [health] problems," he testified. He expressed the conviction "that diet products and food supplements can do a lot of good. I would not want to see them prohibited." He suggested, however, that standards be established and that the FDA "enforce these standards so that the public can be confident that these products are safe."
The final two lay witnesses testified to personal tragedies. Bernard Lehman, of Anaheim, California, formerly from a town near Nashville, Tennessee, said that he is not able to work because he has Hodgkin's lymphoma, a form of cancer. A few months ago, while "basically bedridden," he claimed that a distributor in Tennessee told him and his wife that she could lose weight taking Herbalife products, that both could earn needed income, and that "the Herbalife products would help to cure my cancer."
Lehman named the distributor and charged, "He told us this orally and showed us some brochures which said this" in writing. "However, he gave us different brochures without this information and said that he only had one copy of the special brochure, and he had to keep it for his use." Lehman summarized by saying that the distributor "basically said that the Herbalife products would act as a cure-all."Although he and his wife had "bad reactions" to the Herbalife products, they continued taking them "because we believed that we could make lots of money and we thought our own bad reactions to taking the products were unusual." They spent about $1,800 for inventory and publications and sold about $100 worth of Herbalife products before asking to get out and get their money back. They eventually received $1,000 from the distributor and still have $700 worth of product they "would just like to get rid of...and forget about."
Cynthia Guillaume Lee, of New Orleans, told the pitiful story of her late husband, Bivian Lewis Lee, Jr., who had retired as a National Football League player in 1976. He became a Herbalife distributor in October 1984 because "the extra money sounded real good," said Mrs. Lee. Although he was not overweight and "was very much against taking any kind of diet product," he began taking a Herbalife product because "he said that if he was going to sell it, he would at least try it out."
Two weeks later, Bivian, age 35, was dead. His widow testified:
I know that I'm not a doctor. I know that I'm not qualified to give medical opinions. But I do know that my husband was a perfectly healthy man. I saw him deteriorate from the perfectly healthy man to his death. And it all began when he started taking Herbalife. I want to tell what happened to me-it's not easy for me to do this-because I want this subcommittee, or the Federal Food and Drug Administration or somebody to investigate why my husband was alive and well until he started on the Herbalife products and now he's dead. I want to encourage the subcommittee to look into this so that other young mothers won't find themselves in my position.
 
Mrs. Lee submitted an affidavit by Dr. Van Itallie, who had reviewed the autopsy protocol prepared by the Orleans Parish Coroner's Office and other records relating to Bivian Lee's death. The affidavit cites an article Van Itallie co-authored, entitled "Cardiac dysfunction in obese dieters: a potentially lethal complication of rapid, massive weight loss" [American Journal of Clinical Nutrition 39:695-702, 1984]. The article discusses the cases of 17 obese but otherwise healthy persons on VLCs who died of cardiac arrhythmia. "Basically," the affidavit says, "severe restriction of caloric intake causes the body to ulitize and deplete its protein. The heart is a muscle, made of protein, and it is not spared . . . . depletion of protein from the heart may be followed by cardiac arrhythmia and death. I refer to this as the 'liquid protein syndrome', but it may develop from any drastic reduction in caloric intake. My thesis further holds that persons with lesser stores of body fat are more likely to experience the cardiac dysfunction. Fatter dieters seem to survive longer because they are better able to conserve their body protein."
Van Itallie found this thesis consistent with Bivian Lee's case, particularly because he was "persuaded by Lee's Body Mass Index, indicating that he had lesser stores of body fat."
This article was published in the September 1985 issue of Nutrition Forum, when Mr. Fanning edited and published a newsletter called Con$umer New$weekly. Before that, he was a science writer for The Atlanta Journal and director of information for the U.S. Centers for Disease Control and Prevention. Bivian Lee's lawsuit was settled out of court for an undisclosed sum which was undoubtedly substantial.

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