On a Sunday morning, a sunny day with temperatures in the low 80s and humidity around 70 percent, Bechler came for a regularly scheduled workout.

While in 2005 the eyes of America were on six of baseball's biggest names discussing steroids, two Orioles pitchers were at a South Florida hearing involving another banned substance. What happened is that after about 60 percent of the light running workout was completed, Steve Bechler became became faint and collapsed near the outfield fence. He was rushed to the training room, where he received treatment for about twenty minutes until emergency personnel arrived. His body temperature temporarily reached 108 degrees, and heat was blamed for his loss of con­sciousness. At the hospital, Bechler's condition declined, and he was placed on a respirator. From that point on, medical staff fought a losing battle to stabilize him, and he died, according to a team physician, from multi-organ failure due to heatstroke.1

The medical examiner who conducted the autopsy on Bechler found ephedra in his system and concluded that the toxicity of ephedra had played a significant role in his death. According to Bechler's family, he had used Xenadrine RFA-1, a diet supplement that contains ephedra. Bechler's widow, who was seven months pregnant when her husband died, filed a lawsuit against Nutraquest, the maker of the supplement sold by Cytodyne.3 According to The New York Times, Xenadrine's label describes it as a "rapid fat loss catalyst," and says, "Lose weight fast."2 It has been implicated in 155 deaths.

In April 2004, ephedra was removed from stores and web sites that sell diet supplements, by order of the Food and Drug Administration. The ban targeted ephedra supplements that were advertised for weight loss, muscle building, and athletic performance. This doesn't mean that ephedra will disappear entirely. Herbal medicine preparations containing ma huang, the type of ephedra grown in China, will still be available from acupuncturists and herbalists. These are often recommended for conditions such as colds, asthma, cough, and headache.5 Further, manufacturers of some ephedra products are seeking to reverse the FDA ban. 4

Steve Bechler was one of millions of Americans who are struggling to lose weight. Like many, he pursued a course that was heavily promoted, but somewhat risky. Ephedra earned $1.3 billion at its peak, and an estimated 13 million people had tried the supplement.6 Like many, Bechler apparently hoped for a quick solution to a lifestyle problem.

Treatments for excessive weight offer an opportunity to examine how conventional drug therapy, surgery, and even diet supplements are promoted and used for a common lifestyle problem. Although dietary supplements may not strike you as medical advances or high technology, their promotion and risks have similarities to those of new pharmaceuticals.

Over 50 percent of Americans are overweight or obese. For those who are, and even for many of those who aren't, finding a way to get slim or stay slim commands plenty of attention. Weight loss and diet aids are touted everywhere-on TV and radio, on the Internet, in magazines, and even on flyers that appear on car windshields and telephone poles. Ads describe miraculous ways to lose weight quickly.

But as the American Obesity Association notes, if there really were a miracle cure, our weight problems wouldn't be so severe. Rates of obesity have risen at an epidemic rate during the past twenty years. Despite the advent of the South Beach Diet and the ever-growing marketing of low-carb snacks, trends inc low-carb snacks, trends indicate that rates of overweight and obesity are likely to increase.

Everyone knows that being overweight is bad for your health. Overweight individuals are more susceptible than average to high blood pressure, high cholesterol, diabetes, heart attacks, heart failure, stroke, gallstones, gout, arthritis, sleep apnea, some types of cancer, complications of pregnancy, menstrual irregularities, infertility, bladder control problems, and kidney stones. They also are at higher risk for depression, eating disorders, distorted body image, and low self-esteem. Obesity can be embarrassing and demoralizing. Even this list is probably incomplete, as more studies appear every day.

About 40 percent of women and 25 percent of men are trying to lose weight at any given time. Nationwide, another 55 percent of Americans are actively trying to maintain their current weight. Some 45 million Americans diet each year.

In the USA alone, consumers spend about $30 billion per year trying to lose weight or prevent weight gain.7 This includes spending on diet sodas, diet foods, artificially sweetened products, appetite suppressants, diet books, videos and cas­settes, medically supervised and commercial programs, and fitness clubs.9

There are thousands of diets that promise to shed pounds. The low-fat and high-fat camps and the advocates of low-carbohydrate diets compete for credibility. There's rarely a week when there aren't one or more diet books on the bestseller list. But the evidence that these diets can produce long-term weight loss for most people is slim at best. In the weight-loss market, separating truth from promise is nearly impossible.

Almost as popular as "how to" diet books are commercial and noncommercial weight-loss programs. Most of these programs involve restricted calorie diets coupled with individual or group counseling. Few participants keep the weight off for long. In fact, the Federal Trade Commission has brought action against some companies, challenging their weight-loss and weight-maintenance claims.7

It may be that the most successful weight losers are do-it-yourselfers. In a survey of more than 32,000 dieters conducted by Consumer Reports, nearly a quarter had lost at least 10 percent of their starting body weight and kept it off for at least a year.

About 12 percent were "superlosers": those who had maintained their weight loss for five years. The superlosers usually did it on their own, without programs or drugs. Most identified exercise as the main factor in their success.

Only 14 percent of the superlosers ever signed up with Weight Watchers, Jenny Craig, or other commercial programs, and only 6 percent used dietary aids like Metabolife or Dexatrim. A Consumer Reports editor said that the report "overturns the long-held conviction that to lose weight, you have to enroll in an expensive program, buy special food, or follow the regimen of a particular diet guru.9

Magic Bullets: Diet Supplements

Nowhere is the hype more evident than at your local drugstore. Herbs and supplements that claim to control weight include green tea extract, chitosan, psyllium, chromium and chromium picolinate, 5-hydroxytryptophan, soy isoflavones, ma huang (a.k.a. ephedra), guarana, kava, St John's wort, spirulina supplements, white willow bark, 1-carnitine, pancreatin, fiber, dehydroepiandrosterone, coenzyme Q10, dandelion leaves, hydroxycitric acid, betaine, calcium, docosahexaenoic acid, eicosapentaenoic acid, glutamine, vitamin B5 (pantothenic acid), vitamin C (ascorbic acid), vitamin D, zinc, glucomann, pectin, cat's claw, blessed thistle, and probably many others. For almost every one of these "diet supplements," there have been claims that it facilitates weight loss.

Americans spend huge sums on these products, with estimates ranging from $6 to $10 billion each year. Sadly, there's little evidence regarding the efficacy of these herbs and supplements. The FDA doesn't authorize or test dietary supplements. This leaves room for a wide range of claims, both fraudulent and legitimate.

The 1994 Dietary Supplement Health and Education Act freed the manufactures of diet supplements from having to prove that their products were safe and effective. Under this act, the companies aren't required to report adverse reactions or deaths resulting from their products to the government or to consumers. Some advisory groups are working with Congress to try to change this legislation.10 Both the FDA and Congress are considering initiatives to require makers of diet supplements to test their claims and show supporting evidence. In the upcoming months, debate between government and manufacturers should be lively.

Ephedra, which played a part in the death of Steve Bechler, was well known to have problems. In 2003, The New York Times reported that the Food and Drug Administration received more than a hundred reports of deaths among ephedra users, as well as 16,000 reports of other problems, including strokes, seizures, heatstroke, heart disorders, and psychotic episodes. 11 Even so, only the worst cases draw attention. The FDA itself estimates that it gets reports on fewer than 1 percent of severe adverse effects linked to dietary supplements.

The allure of these treatments affects not just overweight people but also those who are trying to stay slim. A friend recommended some tablets to Jennifer Rosenthal, age twenty-eight, a truck dispatcher and the mother of a four-year-old in Long Beach, California. The pills sounded wonderful: They were supposed to increase the metabolism to help the body burn off fat. "It was like you're doing aerobic exercise while you're just sitting there," said Jennifer. The capsules were sold over the Internet for $39.95 for ninety and contained only one ingredient-usnic acid, a chemical found in some lichen plants. Jennifer took half the maximum dose recommended on the label for two weeks, skipped two weeks as the label directed, and then started again for a total of seventeen days.12

In less than a month, Jennifer was in a coma with liver failure, con­nected to a respirator. Her rapid deterioration prompted the hospital to put her at the top of the waiting list for a liver transplant, which she got within days. Doctors observed that her own liver was so badly damaged that it had shriveled to about a third of what it should have weighed. They concluded that almost certainly the liver damage was related to usnic acid, because there was no other explanation for her illness.

Her surgeon told reporters, "This is a young woman who almost lost her life. Although she's got her life back now, she has to be under life-long medical care. Her life has been altered forever. The fact that you can get these things over the Internet is mind-boggling. 12

Over the years, various treatments have been found ineffective, and products such as ephedra are coming off the market. In the early 1990s, ineffective diet patches were also removed from the market. The Federal Trade Commission warns against other ineffective weight loss products: magnet diet pills that purportedly "flush fat out of the body," bulk fillers like guar gum that can cause intestinal obstruction, electrical muscle stimulators, "appetite suppressing eyeglasses," and "magic weight-loss earrings.i' You can probably still find these products being touted for sale. It's not illegal to sell ineffective treatments that aren't regulated by government.

No one has yet developed a highly effective prescription drug for longterm weight loss. By far the most common prescription diet pills are appetite suppressants, a family of drugs that includes Meridia (sibu­tramine) and Adipex-P (phentermine). These drugs increase the amount of serotonin and catecholamine in the brain, and these brain chemicals modulate mood and appetite. At sufficient levels, they reduce hunger and create a feeling of fullness. Most people taking these drugs lose no more than ten to fourteen pounds. Many regain the weight when they stop taking the drug.13

Another drug, Xenical (orlistat), blocks the absorption of dietary fat in the intestines. Up to a third of all ingested fat may be blocked. But there are sometimes unpleasant side effects like urgent bowel movements, gas, and irregular menstrual periods.

Dexfenfluramine (Redux), phen-fen (a combination of fenfluramine and phentermine), and fenfluramine (Pondimin) were withdrawn from the market in 1997 because of side effects involving the heart and lungs. Doctors wrote 18 million prescriptions for these drugs in 1996, and six million people in the United States reportedly used Pondimin or Redux 14/15

Wyeth, the manufacturer of phen-fen, has subsequently faced tens of thousands of claims. In 1999, Wyeth settled a class action lawsuit for over $3 billion." In April of 2004, a Texas jury awarded over $1 billion to the family of a woman who died of lung disease allegedly caused by phen-fen. According to The New York Times, the company has set aside nearly $17 billion to cover its liability.16

Wyeth had used the strategy of placing ghostwritten articles in the medical literature to help promote the drug, according to news accounts. According to a lawsuit, the company tried to play down or remove descrip­tions of side effects from the articles. At least one guest author said that he was unaware that Wyeth had financed or edited his article.17

Many people continue to hope that such drugs will offer a one-stop solution to weight control-the technological fix. Most evidence indicates that any weight-loss drug must be used along with diet and physical activity to have any substantial effect. However, several major pharmaceutical companies are developing new prescription drugs for obesity, so the story is far from over.

Some people turn to surgery for a cure. The NIH suggests that only men who are about one hundred pounds overweight or women who are at least eighty pounds overweight should consider surgery Those who have diabetes or life-threatening cardiopulmonary problems might consider surgery at slightly lower weights.17

Gastric bypass surgery, also called bariatric surgery, has become the most common type of weight-loss surgery The operation certainly works, and many patients lose about a hundred pounds. Successful surgery can improve obesity-related health complications, psychological well-being, and quality of life. Furthermore, after a year of recovery, even patient survival is improved.17

But just as with every other treatment, there are drawbacks. Unlike drugs, though, surgery can't easily be reversed at a later date. The International Bariatric Surgery Registry puts the thirty-day mortality rate at a reassuring 1 in 300. The real mortality rate, however, may be far higher than that-possibly as high as 1 in 50 cases, close to the death rate from coronary surgery.18

The New England Journal of Medicine notes: "Bariatric surgery is not cosmetic surgery. It is major gastrointestinal sur­gery performed in extremely large patients whose obesity puts them at risk for complications and death-both from the medical problems with obe­sity and from the surgery itself."19

The high estimate of mortality comes from research by David Flum, a University of Washington surgeon who analyzed data for over three thou­sand patients who underwent gastric bypasses. Flum attributes the high complication rate, in part, to inexperienced surgeons who are eager to add the lucrative but demanding surgery to their repertoire. "You have lots of obese patients, insurers willing to pay, and doctors just learning the operation. It is the perfect storm for bad outcomes," he says. The operation can work wonders, Flum admits, "but patients need to go in with their eyes open. 18,20

With growing demand for the surgery, it has become big business, and many medical centers are scrambling to start programs. In Massachusetts, the state Department of Health had to investigate widely publicized reports of surgery-related deaths.19,z1 The president of the American Society for Bariatric Surgery notes: "All of a sudden there has been this explosion of people doing the procedures, and some, quite honestly, are not doing the operation the right way or do not follow up the right way. "21 Experts say that some doctors have even encouraged obese patients to gain more weight so that they would become heavy enough to qualifyfor the surgery.20

Even successful surgery isn't a magic bullet. Dr. James Ostroff at the University of California-San Francisco, says, "many patients are misled into thinking that bypass surgery will solve weight problems forever without any effort on their part."" Without proper follow-up, including dietary and often psychological counseling, patients often gain back all the weight they lost or, conversely, become malnourished. The head of one nutrition center says, "We consider these people our patients for life”.21

Yet another surgical "cure" for overweight is liposuction. Liposuction is the removal of fat deposits under the skin using a hollow stainless steeltube with the assistance of a powerful vacuum. Although generally safe, liposuction is expensive, and removing subcutaneous fat doesn't address the causes of excessive weight. It's primarily a cosmetic procedure, and it's most effective for those who aren't severely overweight. Of major concern for those considering liposuction is finding practitioners with the qualifications to do the procedure, as serious complications can arise.22

Obesity experts, the surgeon general, and public health officials argue that individual efforts and technology alone won't solve the broader obesity epidemic. Individual treatments for overweight and obesity need to be considered in the context of the culture and the physical and social envi­ronment in the United States.

For example, the bestseller Fast Food Nation describes how Americans have come to frequent high-volume, high-fat restaurants.23

Use of the automobile is often invoked in explaining the obesity epidemic, as is the overuse of television. In addition to reducing the need to walk, cars have changed the built environment. There are fewer sidewalks, little opportu­nity for safe bicycling, and little attention to attractive environments for exercise. Changes in entire social and physical systems may be needed in order to induce a largely inactive and overweight population to control their weight effectively.

For a condition that is so prevalent, with health impacts that are so great and a public that is so willing, far more resources might be put into environmental change, as well as evaluating various weight-loss treatments and disseminating the results. It's startling that the first randomized trials of popular diets have been published. 24/25

A realistic expectation for individuals needs to be coupled with a realistic expectation for populations. Even a small weight loss on a population basis could yield many health benefits at a societal level. Like the war on smoking, the war on obesity will take decades, with many ups and downs in different population segments. Helping the public sort out the dangerous from the benign, the effective from the ineffective, and "waste of money" from "worth the investment" should be a high priority for public health and medicine.
 

1.O'Keefe M. O's pitcher dies after workout; heatstroke is cause; docs test for ephedra. Daily News (New York), February 18, 2003, p. 53.

2. Chass M. Baseball; varied factors caused pitcher's death. The New York Times, February 19, 2003, p. D1.

3. Sheinin D. Bechler's widow plans to file suit; ephedra company would be focus. The Washington Post, February 25, 2003, p. D1.

4. Times wire services. In Brief/Utah: Company challenges FDA ban on ephedra. Los Angeles Times, May 5, 2004, p. A17.

5. Duenwald M. Despite FDA ban, ephedra won't go away. The New York Times, February 17, 2004, p. F5.

6. Costello D. Medicine; as ephedra ban takes effect, enforcement becomes the issue; FDA says it will monitor online availability, but critics contend people will be able to get the supplement. Los Angeles Times, April 12, 2004, p. F3.

7. Federal Trade Commission, Food and Drug Administration, National Association of Attorneys General. The facts about weight loss products and programs. Available at: http://vm.cfsan.fda.gov/-dms/wgtloss.html. Accessed March 25, 2004.

8. American Obesity Association Fact Sheets. Available at: http://wwwobesity.org /subs/fastfacts/Obesity-Consumer-Protect.shtml. Accessed April 22, 2004.

9. CNN.com. Consumer Reports reveals successful diet tips. May 7, 2002. Available at: http://www.cnn.com/2002/HEALTH/05/06/died. Accessed May 23, 2004.

10. Burros M. National Briefing Washington: Group wants rules on food supple­ments. The New York Times, April 2, 2004, p. A17.

11. Pear R, Grady D. Government moves to curtail the use of diet supplement. The New York Times, March 1, 2003, p. Al.

12. Grady D. Seeking to fight fat, she lost her liver. The New York Times, March 4, 2003, p. F1.

13. Grady D. Quest for weight loss drug takes an unusual turn. The New York Times, April 15, 2003.

14. Morrow DJ. Fen-phen maker to pay billions in settlement of diet-injury cases. The New York Times, October 8, 1999, p. Al.

15. Anonymous. Diet drug firm accused of funding favorable articles. Los Angeles Times, May 24, 1999, p. A8.

16. Abelson R, Glater JD. A Texas jury rules against a diet drug. The New York Times, April 28, 2004, p. Cl.

17. U.S. Department of Health and Human Services. Gastrointestinal surgery for severe obesity. NIH publication No. 01-4006, December 2001. Available at: wwwniddk.nih.gov/health/nutrit/pubs/gastric/gastricsurgery.htm. Accessed May 23, 2004.

18. Langreth R. Operation! Forbes, October 27, 2003, p. 246.

19. Steinbrook R. Surgery for severe obesity. N Engl J Med 2004; 350: 1075-1079.

20. Grady D. Operation for obesity leaves some in misery. The New York Times, May 4, 2004, p. F1.

21. Davis R. Proliferation of obesity surgeries raises alarm. USA Today, May 5, 2004, p. 7D.

23. Narins RS. Liposuction. Dermatol Clin 2001; 19(3), 483-489, ix

 

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