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.
One company that hasn't is Roche Holding AG, a Swiss company that makes Xenical. Roche's strategy involves bringing a scientific approach to the weight loss market in China. It's product, Xenical, launched in January 2001, was the first prescription weight-loss drug approved by the Chinese government. Strangely enough, all other weight-loss products are labeled "health products" and cannot be sold in hospitals or prescribed by doctors and thereby avoid regulation. In the Roche program, patients come to a hospital, clinic where they are questioned about their eating habits. They are weighed on a high-tech scale connected to a computer that calculates body mass and spits out an elaborate diet and exercise regimen. Each patient leaves the hospital with the regimen and a bottle of Xenical. Roche sends one doctor from each of its hospital clinics to Australia for a two-week training program and runs one-day training sessions for 2,000 doctors in China. The clinics run independently of the hospitals' regular services, so why do hospitals allow these programs? The answer is revenue. A month's supply of Xenical costs about $72 and you can only buy it at the hospital. For the average Chinese, $72 is a lot. But customers seem to be satisfied with this scientific approach because they feel more comfortable having seen a doctor. Roche expects to sell $12 million of Xenical in the first year of sales.
Shifting from Southeast Asia to South America. ..Latin American women have always been known for placing great emphasis on their appearance and glamour. So, is it surprising to find that Brazilian women are taking prescription diet pills by the thousands? The problem there is similar to that in the U.S. A study in Sao Paulo found that three-fourths of the women over age 20 who wanted to lose weight were taking prescription diet pills intended for the obese when they weren't obese. In that same study, 86% reported that they had experienced side effects, but had not told their doctor about them because they were afraid that the doctor would revoke the prescription.
Frequently other drugs are prescribed in combination with the prescription diet pills to speed up weight loss. Thyroid hormones, tranquilizers, diuretics, and laxatives are often combined with the diet pills in spite of a 1998 Brazilian law that prohibits these mixtures. But doctors still prescribe them and compounded formulas are prepared at "manipulation" pharmacies, small drug stores that combine active ingredients prescribed by doctors. Today, there are about 4,500 compounding pharmacies -twice as many as a decade ago. Some of the compounds that they produce contain seven to fifteen different substances which women willingly swallow in the hopes of remaining pencil-thin. As if that weren't enough, a recent study found that some prescriptions were written by dead doctors and others were written by physicians who weren't registered as required by law.
One doctor had written 7,678 prescriptions for appetite suppressants in one year -99% of them filled at the same compounding pharmacy. Clearly, the 120 drug-surveillance inspectors in Sao Paulo can't cope with this onslaught.
We might join with one writer who asked "Who's to blame (for the Redux and fen/phen debacle)?" Answers are: (1) The U.S. FDA which brushed off critics' and scientists' misgivings to approve pills such as Redux and fen/Phen products?
(2) The drug companies that produced, tested and zealously promoted the pills? (3) The doctors and diet clinics that eagerly dispensed them, even to patients for whom they were never intended? (4) Uncritical media that ballyhooed the pills as "miracle" drugs and! "magic bullets" in the war against fat? (5) A fanatically weigh-conscious public so eager to shed pounds that it demanded the pills at any cost? Given the similarity of the depth and diversity of weight-loss products in the U.S. and the similarity and seriousness of weight-loss product problems in other countries, we could add questions about lack of regulation, lack of inspectors and enforcement officials, and the willingness of individuals to go to prison to smuggle diet pills, of all things, and you've got a very serious global problem with no easy solution in sight! It's only going to get bigger or is that fatter?
Questions for Discussion:
1. How does perception affect the quest for an ideal weight?
2. What are the motives that drive purchase of weight loss products? Why do these seem to be universal (Taiwan, Thailand, China and Brazil)? Why would people buy products that they really don't believe will work?
3. How do self concept and the search for an ideal weight interact with each other?
4. How do group influences affect one's perception of the ideal weight and decisions to purchase diet products?
5. How could attitudes toward what is the ideal weight be changed so that a size 14 for women is perceived as average?
6. Should government agencies take a greater role in policing this industry? .
7. Answer the writer's question about who's to blame. What can or should be done to prevent another Redux, fen/phen, or PP A debacle?
References:
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