Achieving Slimness: Weighing the Consequences

The Fat-Be-Gone ring: This is sold on the Web by American Design, a St. Louis jewelry maker, and in retail chains like Walgreens. Advertising for it claims that it taps into the principles of acupuncture and acupressure and that the effect of wearing it is like jogging six miles a day. Wear it on the little finger to slim the thighs; on the ring finger to slim the stomach; on the thumb to slim the face, etc. All this with “no drugs, no starving and no sweating.

” Aoqili Defat Seaweed Soap. Use it in the shower and watch the fat go down the drain. Plastic earplugs that curb the appetite -who knows how these work? Miracle pills that get rid of excess weight without dieting or exercise.

Most of those sound ridiculous, right? Even the people who buy them are dubious. Lynn McAfee, director of the Council on Size and Weight Discrimination, an advocacy group for overweight people has a Fat-Be-Gone ring and so do at least four of her friends.

She says “In the back of my mind, I say, ‘well, maybe it will work.'” Obviously she’s not sold, but… Mrs. April Mankowsky who bought the soap says, “I’m a fool. I knew it wasn’t going to work. But I’m desperate, and the ad said, ‘Watch the fat go down the drain.'”

The key point is Mrs. Mankowsky’s comment that she’s desperate. That’s true of a lot of Americans. Over half of the U.

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S. population is overweight and most of them are obese which means that they weigh-in at least 20% more than the maximum weight for their frame. Unfortunately, they’re in a culture that worships youth -slim, good-looking, fit youth. Models are considered too fat if they are more than a size 6. That in a country where the average (average, mind you) woman is a size 14. If a model such as Carre Otis becomes a size 12, she is considered a “plus size” even though she’s still smaller than the average woman. Amazing!

Doctors today think that obesity might be caused by genetics and that the best way to deal with weight problems is to exercise three times a week for a minimum of 30 minutes and to eat a sensible diet. While that is probably also the cheapest approach to weight loss, U.S. citizens seem intent on finding the magic pill, potion, contraption, or plan that will enable them to lose weight without giving up French fries and without having to walk, jog, jump, or run. The result is an industry of over $10 billion dollars with consumers who will try almost anything.

There are many ways to lose weight and here’s a description of eight popular means.

1. Commercial weieht-loss centers. Examples are Diet Center, Jenny Craig, Nutri/System and Weight Watchers. In 1995,7.6 million Americans spent over $1.78 billion at these establishments. They all charge an enrollment fee and on-going fees on top of that. You must weigh in each week, pay for coaching from counselors and some require that you purchase low-calorie meals from the company. In a year, you can easily spend well over $1,000 on these plans.

The major problem with this approach besides the cost is that the weight comes back, and you usually have to pay another enrollment fee when you start the plan again.

2. NonDrofit SUDDort GrouDs. The biggest is Overeaters Anonymous which is like many other twelve step programs. You meet once a week with others who are trying to control their eating. Costs are negligible, as contributions at most meetings are voluntary. These programs can be effective in helping people identify emotional triggers for overeating, but they do not provide a regimented diet or plan which many people need.

3. Over-the-counter Diet Pills. Drugstores and supermarkets sell dozens of these products, of which perhaps the best known are Acutrim and Dexatrim. They work in part by stimulating your metabolism, but there’s no scientific proof that they provide more than temporary weight loss. But Americans spend over $100 million on them every year anyway. The active ingredient in these pills is phenylpropanolamine (PP A), which has been associated with elevated blood pressure, seizures, and strokes. (More on this later.)

4. Meal-reDlacement Shakes. Nearly eight million dieters consume low-calorie shakes in place of real meals to help lose weight. Shakes are sold in grocery stores (the well-known Slim-Fast) or through network marketers such as Herbalife, Nu Skin and Shaklee. While these might help in the short run, they don’t provide a long-run weight control method and the cost of these can be quite high -especially the network marketer products.

5. Custom-made Weieht-loss Plans. While quite expensive, this method can be the most effective. First, you ask your physician to create a weight-loss program tailored for you. It should include an exercise plan, behavior modification, support groups and menu planning. You will have to pay for a physical exam and lab tests initially plus continuing monthly charges for visits to nutritionists. A University of Pennsylvania study found that very obese patients (at least 85% over their ideal weight) dropped an average of24 pounds if they followed the program for six months and were less likely to gain that weight back.

6. Prescription Drugs. These are the products that have created the most “excitement” in the last few years about weight loss products. Prescriptions for pills such as Redux and the weight loss cocktail fen/phen spread throughout the population like wildfire.

Unfortunately, these drugs are most likely to have serious side effects such as pulmonary hypertension, heart valve problems, and seizures and former users have successfully sued the companies selling the products.

7. Medicallv SuDervised LiQuid Diets. If you have a body mass index of 30 or more and aren’t overly attached to solid food, you could consider a very-low-calorie liquid diet such as Medifast or Optifast. (Oprah Winfrey used the latter to lose 69 pounds which she quickly regained.) For three months, you take the liquid which is made from a protein powder. This provides you with 400 to 800 calories per day. Then you shift to a three-month diet plan in which you can eat regular food. You have to be under a physician’s care for the entire six months and the cost of this is in the thousands.

8. 8. Surgery. If you have a body mass index of at least 40 (about 100 pounds of excess weight for men and 80 pounds for women), you are eligible for surgery in which surgeons typically use staples and bands to reduce the stomach’s capacity from about 32 ounces to as little as half an ounce. The cost is usually over $15,000, but it can be covered by medical insurance if the procedure is considered medically necessary.

Weight loss is usually 50 to 100 pounds in the next two years and the vast majority of patients keep off at least half that weight for the next five years. On the other hand, there can be serious complications. Between 10 and 20 percent of patients require follow-up surgery to correct problems such as abdominal hernias.

In many ways, the weight loss business is the perfect industry for unscrupulous operators. Unless a new drug is involved, products are for the most part unregulated. Take for example, the Seaweed Soap. Jason Green, a casino worker from Louisiana, sells this soap on his web site. He details how dieters can wash away fat in the shower and claims that the soap penetrates the pores and jump-starts the metabolism. Furthermore, the site claims that users can shed 25 pound in two months!

But Mr. Green has never talked to the manufacturer, a company in Guangxi, China or to the distributor from whom he buys the product. Where does he get his knowledge? From the packaging on the product and from other vendors on the Internet. He surfs the net to see what other vendors claim and copies their claims. “They just leave it up to me,” Mr. Green says. The distributor, Wing Hop Fung Ginseng, Inc. in Los Angeles admits that it provides no information on the product’s efficacy.

Clearly this situation ought to be illegal (assuming that it isn’t). The Federal Trade Commission requires advertisers to have proof of their claims. But first, they have to know about the claims. The growth of the Internet in which hundreds or thousands of individuals can sell such products and the growth of cable television stations has provided advertising opportunities that far exceed the F. T .C.’s policing capabilities. By the late 1990s, advertising for weight loss products soared to over $100 million -more than double what it was in 1995. Cable stations, hungry for programming and revenue, readily accepted infomercials for weight loss products. Indeed, advertising for weight loss products was the fastest growing TV advertising category at the millennium.

Out of “enlightened self-interest,” Elissa Myers, president of the Electronic Retailing Association, says that the association has begun to refer egregious marketing claims to the F.T.C. In April 2000, the collaboration of these two agencies resulted in one of the largest settlements to date -a $10 million judgement against Enforma Natural Products for its best-selling pills called Exercise in a Bottle and Fat Trapper. In September 2000, the F. T.C. sued the product’s celebrity endorser, Steve Garvey (former Dodger baseball star), who had urged TV watchers to indulge cravings for barbecued chicken and ribs “without guilt, without worry.”

Before that collaboration, the F.T.C. had begun “Operation Waistline” to clamp down on companies selling diet products. One product that they went after was SeQuester, a plant-based fiber that supposedly blocked the absorption of fat. Another was Slimming Insoles, which claimed to trigger weight loss by pressing on nerves in the foot. In spite of these efforts, the agency believes that consumers spend over $6 billion on fraudulent diet products annually, over 20% more than in the mid-1990s.

Given the difficulty of policing fraudulent weight loss advertising claims, a coalition consisting of government regulators, health officials, and diet product companies themselves, has begun urging businesses to publicly endorse a set of advertising rules that are more stringent than the federal requirements. Unfortunately, such measures would be voluntary and as an FDA official says, “When you have someone selling snake oil, self-regulation probably isn’t the best form of control.”

While the “snake oils” are a problem, they are not nearly as serious as the problems caused by the diet pill industry. Beginning in the 1970s, diet pills got a bad name when doctors prescribed amphetamines (a.k.a. “speed”), which burned up calories by increasing the body’s metabolism. Although they worked, these had a serious side effect -addiction.

After the speed debacle abated, concern over diet pills declined until the late 1990s when products such as Redux and fen/phen hit the market. When Redux was approved by the FDA in 1996, it was the first diet drug to be approved in 23 years. Dexfenfluramine in Redux caused people to eat less by shutting off appetite. To do this, it triggered the release of serotonin, a brand chemical that induces feelings of fullness and satisfaction.

Was this drug safe when approved? It depends on how you look at this issue. Twenty-two neurologists petitioned the FDA before Redux was approved to delay approval. They cited studies showing that it caused brain damage in laboratory animals and other critics were concerned about an increased risk of pulmonary hypertension, a condition that can lead to heart failure. Proponents pointed out that millions of people abroad had used it with no major problems. The FDA deemed the threats minimal.

The case of fen/phen, the other banned prescription drugs, was somewhat different. Fenfluramine was approved by the FDA in 1973 for short-term use. Not much happened with fenfluramine until 1992 when a study showed that taking it with phentemine would help dieters lose more pounds with fewer side effects. The weight loss cocktail, fen/phen, was born and it quickly became the diet industry’s hottest seller. It should be noted that the two drugs were never approved for combined use. Doctors exercised their right to prescribe them “off label” -which meant together.

Redux was approved in April and by June doctors had written nearly 2.5 million prescriptions for Redux and the number of people exposed to it rose to 60 million. In July, doctors at the Mayo Clinic reported heart valve problems in fen/phen users which led to a closer look at Redux usage. Within two more months, 30% of patients using fen/phen or Redux were reported to have heart valve problems. Subsequently, the FDA took Redux and fen/phen off the market.

If the threat from Redux was minimal, how did so many patients (far more than could be expected) develop heart valve problems? The answer lies in the large number of people taking Redux and fen/phen who should never have had it. These drugs were intended for people who are 20% or more above their ideal weight; only the obese should have been taking them. Instead, lots of Americans who were not even overweight were taking these pills and that raised the incidence of serious side effects.

On the heels of the FDA’s removal of the drugs from the market place, the number of lawsuits involving the drugs rose exponentially. Lawyers actually advertised for diet pill cases! The culprits were Interneuron Pharmaceuticals, a small Lexington, Massachusetts, firm founded by an M.I. T. neurologist and Wyeth-Ayerst Laboratories, a subsidiary of American Home Products (AHP) which made fenfluramine and distributed dexfenfluramine. By April of 2000, over 45,000 people had successfully sued AHP for a total of $3.75 billion and the company had set aside $4.75 billion to cover these lawsuits. Interneuron, overrun with lawsuits that they could not handle, then sued AHP claiming that it had deliberately concealed two dozen reports of heart disease in diet-pill users. Eventually, AHP took over the claims against Interneuron. But the lawsuits did not stop. In April 2001, a Texas State court awarded $56.6 million-the largest settlement to date-to a woman who had used fen/phen for four months. AHP discounted the verdict and called it a “bump in the road” toward the eventual resolution of the diet pill cases. An AHP lawyer believed that the company was on solid legal ground for getting the award reduced and claimed to have settled “thousands” of similar suits for “relatively modest sums.” Furthermore, AHP has reserves of$12.25 billion, so it is relatively unconcerned about future lawsuits.

The problems for the FDA do not end with prescription diet pills. In November 2000, the FDA announced plans to ban phenylpropanolamine, popularly known as PP A, which is found in dozens of household over-the-counter products including Dimetapp, Alka-Seltzer, and Dexatrim. This drug has been around for 50 years and has been used as a decongestant and appetite suppressant in more than 50 over-the-counter medicines. The FDA’s action was prompted by a university study that found an increased risk of hemorrhagic stroke in young women who used PPA-containing products. The study was undertaken because of reports of young women having strokes who had been taking diet pills.

Replacing PP A was difficult. Some companies used herbs containing ephedrine, but that has been linked to problems such as heart attacks and strokes. Further, some states ban the sale of ephedrine-containing products. Companies such as Chattem of Chattanooga, Tennessee (maker of Dexatrim) planned to introduce an ephedrine-free version of its pill that contained green tea and bitter-orange extract. The caffeine in the green tea acts as a diuretic while the bitter orange contains synephrine, a naturally II occurring chemical in the body that is said to suppress appetite. While that helps Chattem, it poses risks for consumers because herbs are considered dietary supplements and aren’t subjected to the same FDA scrutiny as drugs -which no doubt helps to explain how PP A could be on the market for so long!

Another issue in the weight loss product controversy is legislation. Before 1994, the FDA had to approve ingredients used in over-the-counter weight loss products. That forced companies to spend millions on tests to “prove” that their products did help consumers lose weight. But the pre approval process was eliminated in 1994. Nowadays, companies are required to notify the FDA when they put new products on shelves and can be sued by the agency for making false claims. That rarely happens. Although there are over 25,000 dietary supplements on the market, the FDA has only 8,000 on file. Few of those have ever been reviewed by the FDA. “We simply don’t have the resources to investigate them all,” said Dr. Christine Lewis, director of the FDA’s office of nutritional products, labeling, and dietary supplements.

This madness for diet pills is not confined to the U.S. In 1999, suspects were arrested in Taiwan for smuggling diet capsules containing a controlled amphetamine substance into the country from Thailand. This was just one of a string of arrests for smuggling these pills into the country. In Hong Kong, a 27-year-old supervisor collapsed on the floor and died from taking diet pills that, according to the Public Doctors Association president, Dr. Lai Kang-yiu, is extremely popular there. This incident led to calls for increased legislation to monitor the sales of diet pills. In Thailand, diet pills containing amferpramone and phentermine were popular with young people. Taken unwisely, these pills can cause mental problems, heart disease, and death.

In the People’s Republic of China, diet pills have become increasingly popular. As more Chinese lead less arduous lives and have increased standards of living, they are gaining weight! Believe it or not, China ranks second after the U.S. in the number of obese people -70 million. Of course, that is a much smaller percentage of the population than the percentage of overweight Americans, but the problem is just beginning to grow in China where there are hundreds of weight loss products. The market for these is over $1 billion. Products range from “slimming soups” to a traditional herb laxative, dahuang, derived from the rhubarb plant. Due to a minimum of regulation, scams and shams abound. There’s piracy of products and overblown claims. It’s so bad that most foreign drug makers have abandoned the scene to the locals.