TCS Daily

To Your Health

By Sandy Szwarc - July 28, 2003 12:00 AM

Frances Berg, M.S., wrote in a March/April 1999 Healthy Weight Journal editorial that the then new federal guidelines, labeling over half of Americans overweight and "recommending that millions of already weight-obsessed Americans lose weight, are dangerous in that they focus on weight loss, not health. Instead of improving health, they will likely increase the obsession with thinness."


Berg's admonition is being proven every day. As messages of the dangers of obesity and the soaring epidemic become more desperate, so have the weight loss strategies consumers are trying, or being urged to try, with deadly and dangerous effects.


Pill Popping


Pills promising to help achieve a slender body are being gobbled up as never before, even though most doctors do not recommend them for weight loss. An August 2001 Journal of the American Medical Association (JAMA) study even warned that their use will only increase obesity.


Pills are not without risks just because they're sold over-the-counter or are all-natural. Those containing the appetite suppressant PPA (phenylpropanolamine hydrochloride) or benzocaine, for example, can dangerously raise blood pressure and cause heart arrhythmias, according to Weight Loss Products and Program) (Colorado Extension Service). U.S. Food and Drug Administration (FDA) Medical Bulletins have reported increasing numbers and severities of adverse reactions with dietary supplements promoted for weight loss or fat-burning, such as those containing ephedra (Ma huang), guarana or Kola nut, white willow and chromium. The side effects include chest pain, heart attacks, strokes, hepatitis, seizures, high blood pressure or heart rates, psychosis and death.


Ephedra supplements are especially popular, and worrisome, being linked to more than 100 deaths, among them Major League pitcher Steve Bechler in February. The supplement industry estimates 3 billion doses are sold each year, according to an FDA White Paper. An FDA study from January 1993 to February 2001 stated ephedra-containing supplements were associated with more deaths, heart attacks, heart arrhythmias, hypertension, strokes, and seizures than all other dietary supplements combined. The FDA has been proposing stronger warning labels since the 1990s, but is restricted by the Dietary Supplement Health and Education Act of 1994, which currently exempts botanicals sold as dietary supplements from the safety regulations used for prescription and over-the-counter drugs (including the synthetic form of ephedra, ephedrine).


The Federal Trade Commission this month issued three enforcement actions, challenging false advertising claims that certain ephedra supplements cause rapid, substantial, and permanent weight-loss without diet or exercise, that "clinical studies" or "medical research" prove these claims, and that the ephedra weight-loss products are "100% safe," "perfectly safe," or have "no side effects." Meanwhile, the American Medical Association's position, given before Congress last October, recommends the complete removal of ephedra products from the market, saying the risk/benefit ratio is unacceptable. Illinois already has done so; legislation passed the New York State Senate last month and a key committee of the California legislature this month.


Natural diet supplements aren't the only ones with problems. Prescription diet pills have had a shaky track record, too. The evidence demonstrates that they don't work any better than dieting. Within four years, weight lost with diet pills is regained, and then some, said Paul Ernsberger, Ph.D., associate professor of Medicine, Pharmacology and Neuroscience, Case Western Reserve School of Medicine.


And their side effects can be anything but healthy. Researchers at the National Institute of Mental Health found widely prescribed diet pills resulted in irreversible loss of brain nerve terminals, possibly resulting in depression, memory loss, cognitive and sleep problems, and psychiatric disorders, according to a Sept. 26, 1997, HHS press release.


And who hasn't heard about fen-phen/Redux? Wyet-Ayerst Laboratories, the manufacturer, estimates that about 6 million people took the diet pills. When the FDA asked for a recall in 1997, it stated about 30 percent of users had developed abnormal echocardiograms and the pills were the likely cause of defective heart valves, presenting "an unacceptable risk." Long-term controlled studies are ongoing. Next came Meridia, which was released after one year of testing, although it was shown to raise blood pressure, increase heart rate and was recommended only for short-term use in patients without risk for heart disease or diabetes, the very risks most sedentary obese patients have. In exchange for those possible side effects, patients studied lost a mere 7 pounds more than the control group eating the same diet, and they regained any weight lost upon stopping the medicine.


Going Under the Knife


Lured by glossy brochures, glowing accolades from media personalities, such as Carnie Wilson, and even advice from the government, increasingly more Americans, dying to be thin, are going under the knife. The American Society of Bariatric Surgery (ASBS) said weight loss surgeries (WLS) have more than doubled since 1995. The government's Weight-control Information Network (WIN) of the HHS, National Institutes of Health (NIH) calls it "the best option for people who are severely obese and cannot lose weight by traditional means."


The American Medical Association's (AMA) stand is considerably different. It advised surgeons in an April 9, 2003, issue of JAMA to work around the ethical and scientific issues by telling patients WLS is "investigational" and informing them that "it is not known whether these procedures will even help them."


"There is no conclusive evidence that gastrointestinal surgery for weight loss increases longevity or improves overall health," states the stronger National Association to Advance Fat Acceptance (NAAFA) official position. It "condemns gastrointestinal surgery for weight loss under any circumstances" and urges people to carefully examine the hazards and complications before considering it.


The International Size Acceptance Association (ISAA) position has been against WLS since 2001, and last November they issued a statement emphatically condemning the surgery on teens and children. These groups oppose WLS not because they promote obesity, but based on thorough reviews of the research.


Sadly, most patients get their information from the media and those with vested interests in the surgery. If the evidence was better known, it's unlikely as many would rush to gamble with their lives in exchange for a remote chance to lose weight from a procedure that is:


1. Experimental, with very little research to support it.


In a Healthy Weight Journal article comparing the risks and benefits of surgery for weight loss, Ernsberger noted only three animal tests had been reported before the procedures were begun in humans -- highly unusual as most surgical operations are first perfected with extensive animal testing. In one of those tests, published in the American Journal of Clinical Nutrition in 1984, multiple progressive abnormalities throughout the gastrointestinal system were found on autopsy, but it's unknown if these happen in humans as no one's ever tested. Despite the dearth of studies, he noted that as many as two-dozen types of both gastroplasty and gastric bypass are currently in use, along with several modifications of the original intestinal bypass.


Like many patients, Karen Smith, former chairperson of NAAFA's Weight Loss Survivor's Group, said her doctor "never even told me the surgery was experimental." Her account of life after surgery, and those of countless other patients' experiences, makes for anguished reading.


2. Unlikely to make you much thinner in five years.


Smith's group compiled medical research on WLS and found that "10 percent of patients don't lose any weight at all. ...Those more than 200 pounds overweight have only an 8 percent chance of getting down to [within 130 percent of their 'ideal' body weight ]. ... One in 10 loses the weight and keeps it off." The truest picture of the surgery's success and catastrophic complications isn't found in patients during the first few honeymoon years after their surgeries, she said, but after five or more years. But, just try to find them.


Few doctors tell their patients they could end up just as fat five years after the surgery and left with a lifetime of health problems. Edward Eaton Mason, M.D., Ph.D., the inventor of the gastric bypass, expressed concern in Surgery for Obesity (ISBR Newsletter, Fall 1999) "about the focus on the superficial and results from the first year with a lack of concern about how life will be affected when patients are 10 and 20 years out." The risks and side effects over a lifetime raise questions about its use and we still don't have sufficient data on long-term follow-up, he said.


Few studies track statistics long-term, making it difficult to get precise figures on effectiveness. Success rate claims vary wildly, and each measures "success" differently. Many studies claim success when patients maintain any weight loss, according to the Weight Loss Surgery Information Center. Claims included:


·         A 1985 study published in Surgery that found 76 percent of patients failed to maintain weight loss 30 months after vertical banded gastroplasty, the most effective operation of this type.


·         WIN finding that "although most patients regain 5 to 10 percent of the weight they lost, many maintain a long-term weight loss of about 100 pounds." But, it admitted, "the success of WLS depends on the patient's willingness to adopt long-term lifestyle of healthy eating and regular physical activity."


·         A 1999 gastric bypass study that found only 7 percent of patients kept off all the weight they initially lost, only slightly higher than the stated success rate for dieting, which is 5 percent.


3. Unproven to be more effective than a diet.


Consumers might logically expect, since the surgery is endorsed by the weight loss industry and government health entities such as WIN that it has been proven to work better for long-term weight loss than what we currently can do with diet and exercise. They would be wrong. Ernsberger noted that there have been no published clinical trials comparing weight-loss surgery or gastric bypass with conservative clinical treatments; it has not been found to be superior for life expectancy or for anything else.


In one controlled clinical trial in Denmark, published in a 1984 New England Journal of Medicine (NEJM), patients had more health problems than comparable patients who were put on very low-calorie diets. Echoing the need for more clinical studies, Edward Livingston, M.D., professor of surgery at the University of Texas Southwestern Medical Center in Dallas, in the aforementioned April 9, 2003, JAMA, stated his belief that additional trials would show that the benefits of surgery have been "overestimated." He added, "Long-term consequences remain uncertain. Issues such as whether weight loss is maintained and the long-term effects of altering nutrient absorption remain unresolved."


4. The most dangerous surgery performed, besides open heart, regardless of whose numbers you believe.


The minimal potential improvement in health risk factors from surgical intervention, said Ernsberger, can only be mitigated if the risks and complications of the surgery itself are extremely low and the benefits last at least a decade or more. That's not the case, either.


The 2000 Mayo Clinic study on gastric bypass reported that 20 to 25 percent of the patients developed life-threatening complications within five years, in addition to a 10 percent morbidity and mortality during the post-op period. Those are similar rates to phen-fen, which was considered dangerous enough to take off the market. Other experts, including Dr. Livingston, claim complication rates for WLS are almost double these.


Many believe that deaths and complications attributable to WLS have been greatly under-reported. However, precise figures are very hard to come by. Claims differ by surgeon and their specific surgical technique, and the weight of the patient at surgery.


The chances of dying from the surgery even before leaving the hospital "reliably range from 0.2 to 2 percent," said Ernsberger. Surgeons often give the lower numbers, he said, but "they exclude deaths they feel are unrelated to the surgery, which would appear to be almost all of the deaths they see."


Those mortality figures may sound slight, but they represent a significantly higher risk than for other surgeries. Using the NIH's figure, which is in the middle at 1 in 100, the risk with WLS is 1,000 times higher than for a hysterectomy, which has an immediate post-op death rate of 1 in 100,000 patients or 0.001 percent.


Long-term mortality data is especially hard to obtain. Analysis is complicated by the fact that many don't attribute deaths from long-term complications, such as liver cirrhosis, to the surgery, and usually categorize death as "due to obesity" or lump them into the "lost in follow-up" category, Ernsberger said. "The bottom line," he said, "is that NOT ONE randomized clinical trial has ever been reported that gives mortality data."


Ernsberger described more than 60 documented complications of gastrointestinal surgery in Report on Weight Loss Surgery: Techniques, Complications, Case Studies and the NIH 1991 abstracts on "Gastrointestinal Surgery for Severe Obesity." Potentially fatal complications include peritonitis due to leaks in the digestive tract; pulmonary embolism; liver disease; kidney disease; incessant vomiting; cancer of the stomach, esophagus, pancreas and bowel; and vascular thrombosis. Among lesser-known adverse effects, he noted, were neurological complications (nerve or brain damage) in 5 percent of gastric bypass patients, as reported in a 1987 issue of Neurology. An evidence-based approach left Ernsberger to conclude: "When the risks of surgery and long-term complications are taken into account, then it become apparent that the net outcome for the patient who regains weight is highly negative."


WIN estimates a numbing 10 to 20 percent of patients need follow-up surgery for complications, and the ASBS states that the data voluntarily supplied by their surgeon members shows the risk of dying after these secondary operations is three times higher than for the initial surgery. More than one-third develop gallstones and nearly 30 percent of patients develop nutritional deficiencies that can result in anemia and bone disease, arthritis, compromised immune system and hair loss.


Malabsorption operations also carry a notable risk for dumping syndrome, it said, which causes nausea, sweating, fainting, and diarrhea after eating. The more extensive the bypass the greater the risks for complications and nutritional deficiencies, stated WIN, and patients will "require close monitoring and life-long use of special foods, supplements and medications."


5. Permanent; you'll never be normal again.


WLS causes nutritional deficiencies in nearly all patients, according to most doctors, because it surgically creates malabsorption. A recent follow-up study showed that even 10 years later patients were experiencing severe nutritional deficiencies and resulting complications. What many patients don't realize is that they'll never be able to eat normally again. Most WLS survivors can only eat 500 to 1,100 calories a day for the rest of their lives, much of the nutrients in their foods aren't absorbed, and they must forever eliminate certain foods, such as meats, starches and dairy, from their diets because they can't be digested. Starvation diets and those that eliminate foods have been proven to be dangerous for everyone else, so how can a lifetime of them be healthy for these patients?


Just like anyone else on a starvation diet, WLS survivors become obsessed with food. What's rarely mentioned is that WLS often leads to serious eating disorders, according to the ISAA, which noted, "the NIH has referred to the surgery as 'induced bulimia,' and Dr. Matthias Fobi (creator of the 'Fobi Pouch' used on Rosanne Barr) refers to his procedure as 'induced anorexia.'" The problem of anorexia and binge eating after WLS has received very little attention, but for a few studies or editorials in Obesity Surgery.


Looking at WLS from the dark side, it would seem to exemplify the most dire sequela of extreme dieting, eating disorders and surgery, all in one.


It and all the weight loss methods consumers are being urged to try in the name of good health represent exactly what David F. Williamson, Ph.D., editor of NEJM, in the Oct. 7, 1999, issue encouraged professionals to speak out against -- "the excessive infatuation with being thin and the extreme, expensive, and potentially dangerous measures taken to attain that goal."


"Until we have better data," he wrote then, "... we should remember that the cure for obesity may be worse than the condition."


But, as Berg has pointed out: "As long as we have people in power in our institutions and federal agencies who are keeping up the fiction that obesity treatment is safe and effective, we can't move ahead in solving our critical weight and eating problems."


On Wednesday: How we've been "sold" the obesity epidemic.


© 2003 Sandy Szwarc. All rights reserved.


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