The federal government recently ruled that taxpayers will foot the bills for weight loss surgeries and other weight loss treatments for Medicare patients, if medical evidence can demonstrates their effectiveness. This is the door opening to broader obesity-related coverages, as a September 30th New York Times article revealed. According to Karen Ignagni, president of America's Health Insurance Plans, the national health insurance trade organization, everyone's premiums will be impacted if, as expected, private and employer-based health insurance plans follow suit. It's anticipated that as coverage becomes more readily available, more Americans will seek the surgeries and the numbers performed will skyrocket from this year's estimated 144,000 surgeries. So will the costs.
The American Obesity Association, whose sponsors include bariatric surgical groups, weight loss drug companies and weight loss programs like Weight Watchers and Jenny Craig, already succeeded in April 2002 getting the IRS to designate weight loss treatments, including weight loss surgeries, as tax deductible and hence government sanctioned. As our nation faces rising healthcare costs, concerns over troubled Medicare and social security programs and an aging population, many are asking if our healthcare dollars are best spent on these surgeries and where's the proof they're beneficial?
The "study" found nothing of the kind. But it did point out how deadly and costly it can be to base healthcare policies and healthcare decisions on bad science.
Digging Deeper for the Dirt
The study published in the Journal of the American Medical Association was conducted by seven bariatric surgeons around the country, two, including the lead author Henry Buchwald, MD, Ph.D., are paid consultants of the study sponsor, Ethicon Endo-Surgery Inc. It concluded that weight loss surgery (WLS) was effective in achieving weight loss and that "a substantial majority of patients with diabetes, hyperlipidemia, hypertension, and obstructive sleep apnea experienced complete resolution or improvement."
They managed to do this without clinically examining a single patient. Instead, they did a data-dredge, gathering stats on obesity surgeries from articles published between 1990 and 2003. This tactic, called a "meta-analysis," combines the results of a lot of poorly-controlled and problematic studies in an attempt to arrive at something convincing. However, there have been no randomized, controlled clinical trials that have shown any long-term improvements to health or that lives are saved by any of the dozens of types and variations of obesity surgeries being performed. These gastrointestinal operations, also called bariatric surgeries, cause weight loss by restricting the size of the stomach and can rearrange or bypass the small intestines to further reduce absorption of nutrients. As the Agency for Healthcare Research and Quality's Evidence Report "Pharmacological and Surgical Treatment of Obesity" issued in July discovered, randomized controlled trials or controlled clinical trials of these surgeries are so few in number and short-term that the available studies couldn't be used to make inferences about efficacy. So what did the bariatric surgeons use?
All available data on WLS is self-reported from surgeons. While it's well-known that published articles universally report decidedly favorable results, a problem called "publication bias," consumers, media and many in the healthcare system may not be aware of the fallacies behind such results in regards to WLS. Let's look at four.
Selective vision. If a researcher ignores all the bad outcomes, it's sure a lot easier to show positive results. In bariatric studies, an astounding 50% of patients on average are not included in study results -- such patients are termed "lost in followup." That was also the acceptable level by these JAMA authors.
This fact can often be difficult to realize, especially if one just reads a study Abstract, as they may describe the study population as "including patients having undergone bariatric surgery" which really says nothing.
Edward Eaton Mason MD, Professor Emeritus of General Surgery at University of Iowa Hospital and inventor of gastric bypass, launched the International Bariatric Surgery Registry (IBSR) in an effort to promote reliable statistics on surgical treatments for obesity and improve outcomes for patients. Still after 20 years, recent research from surgeons, represented only a 52.9% followup rate of eligible patients, leading him to caution in 1998 "follow-up is insufficient for estimation of ... mortality rates." And again in 2003 he wrote: "We do not have the long-term follow-up information that is needed to fully inform patients of the consequences of their choice of operation."
Pick and choose what to count. These JAMA authors completely ignored complications, didn't even consider them in balancing the risks versus benefits, or look at whether the surgeries actually improved quality of life. They also ignored deaths except for "operative mortality" which they claimed was 0.1% for the purely restrictive procedures (limiting stomach size), 0.5% for gastric bypass, and 1.1% for two other surgical techniques.
These cherry-picked statistics aren't even close to those presented at the 2003 Clinical Conference of the American College of Surgeons. According to the surgeons' own figures based on nearly 63,000 weight loss surgeries, an average of 2% of patients die within the first 30 days as a direct result of their primary surgery. Yet such deaths are as high as 6% with some surgeons and medical centers, especially those performing fewer than 200 weight loss surgeries a year. But that's not all.
An April study in the Annals of Surgery led by Dr. Adolfo Fernandez, Jr. of Wake Forest University Baptist Medical Center, Winston-Salem, NC, noted that while WLS is promoted for the extremely obese as a treatment for comorbidities (health problems), mortality rates are considerably higher among these patients, and are threefold higher in patients older than 55 years. Yet, Medicare provides coverage for the elderly! The unsoundness of paying for WLS for them is compounded by the fact that being fat, even morbidly obese, in retirement age has no effect in worsening mortality risk, according to Glenn Gaesser, Ph.D., exercise physiologist and obesity researcher at the University of Virginia. In fact, voluntarily losing weight among the elderly, even just 5%, is associated with an increased risk of premature death, he says.
But looking just at operative deaths also ignores that most deaths and complications happen to patients after they leave the hospital, according to Marilyn Dahl, New Jersey deputy health commissioner. David Knowlton, chairman of the New Jersey Health Care Quality Institute, told the Star-Ledger on May 2nd that hospital re-admissions for complications are rarely classified in a way that connects them to their earlier WLS. "We should be alarmed at the number of ... deaths and serious injuries being hidden," he said.
In August, the Pennsylvania Health Care Cost Containment Council released an astounding report that found 39% of the state's WLS patients in 2001 required hospital readmissions... at an additional cost of $21,524 each. That's over and above the average hospital costs for the initial surgeries of $35,643, making average total hospital costs for all WLS patients over $44,000 apiece.
According to IBSR statistics, the majority of deaths during the first six months following surgery are operative deaths and the National Institutes of Health conservatively estimates 10 to 20% of patients require surgery for complications. Yet the risk of dying from these secondary operations is 3 to 6 times higher than for the initial surgery, according to the American Society of Bariatric Surgeons and Erik Wilson, assistant professor of surgery at the University of Texas.
Just look at the "honeymoon period." Universally, weight loss surgery articles only report short-term outcomes before long-term complications and weight regain manifest themselves. Most of the reports used by the JAMA authors were under 2 years, although their data gathering was so sloppy that they didn't even know the follow-up period for 10% of the studies they used, or the gender of 8% of the patients.
Dr. Ernsberger, Ph.D., of Case Western Reserve School of Medicine, Cincinnati, Ohio, who's extensively researched the risks and efficacy of WLS and documented more than 60 complications, says several clinical studies of the long-term consequences and looking for improved life expectancies have been started over the past 40 years these surgeries have been performed, but the results were never released. "I think it's because it's bad news," he said. There have, however, been studies finding WLS survivors suffer many more health problems. In fact, the complication rates are so high and the complications so severe that even Dr. Mason cautioned: "For the vast majority of patients today, there is no operation...without introducing risks and side effects that over a lifetime may raise questions about its use for surgical treatment of obesity."
The Mayo Clinic reported in 2000 that 20 to 25% of gastric bypass patients develop life-threatening complications, but the recent Lap-Band U.S. clinical trials done to earn FDA approval reported 89% of patients had at least one adverse event, one-third of them severe. While many consumers believe the newer, less invasive laparoscopic bypasses and lap-band procedures (which tighten a constrictive band around the stomach to make it smaller) are safer, they merely have their own "unique set of complications," according to surgeons Shanu N. Kothari, MD, and Harvey J. Sugerman, MD writing in Healthy Weight Journal. A September 2003 Blue Cross-Blue Shield review concluded these newer procedures had also "not demonstrated improved health outcomes."
Rarely spoken are the long-term effects of nutritional deficiencies. The neurological decline and aging seen after WLS is especially rapid and results from multiple vitamin and mineral deficiencies, said Ernsberger. Both the stomach and small intestines are critical for absorbing many nutrients, including B-vitamins, calcium, iron, vitamin D and protein. Even taking multiple times the recommended amounts of supplements doesn't help because WLS eliminates the proper function of the stomach and gastrointestinal system. Hence, malnutrition problems are not uncommon, according to the National Institute of Diabetes and Digestive and Kidney Diseases and include anemias, osteoporosis and in some cases even brain damage.
In the latest issue of the Journal of Pediatrics, doctors from Cincinnati Children's Hospital Medical Center reported several cases of beriberi, previously identified among adult WLS patients, already showing up in teenagers who'd undergone the surgeries. A formerly rare disorder in Western societies, beriberi is caused by thiamine deficiency typically seen in starvation and severe alcoholism. It causes dementia and neurological damage that's usually irreversible. In fact, next month's Neurology reports 16% of WLS patients develop permanent neuropathy largely explained by the nutritional deficiencies imposed by the surgeries.
WLS also sentences patients to lifelong, severely calorie-restricted diets. The unhealthfulness of long-term starvation-level diets and protein shortages have been well proven (with centuries of evidence) to significantly shorten people's lives. And good nutrition, including a growing list of micronutrients, is being shown to be imperative to help prevent cancers and other chronic diseases. We may not have begun to realize the true costs of these surgeries in human life and suffering.
Use "false surrogate endpoints." If a drug, diet or surgery claims success because it lowers some believed risk factor like high blood sugar, but fails to tell you that more people actually died after the "treatment," blood sugar was a "false surrogate endpoint."
The JAMA authors claimed obesity surgeries to be beneficial because blood cholesterol levels, body weight and fasting blood sugars were lower after the surgery. Well, lots of things reduce these numbers which are anything but healthful. According to the Dr. Joseph F Smith Medical Library, acute illness, high fevers, starvation and even recent surgery lower blood cholesterol levels. And according to the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, gastric surgeries can reduce blood sugars because of the rapid passage of food into the intestine but fasting blood sugars also go down with critical illnesses, hormonal deficiencies and certain tumors. Finally, weight loss can result from any number of unhealthy and deadly things such as heroin abuse, liver failure and cancer.
The authors cited a 1995 study led by David Williamson, Ph.D. at the CDC as proof that weight loss meant reduced mortality. This study was based on questionnaires submitted by women in 1959 and 1960 about their diets, compared with 1972 national vital statistics. There was a companion study done on men. But what these studies actually found was that among healthy fat people, losing weight gave no reduction in all-cause mortality or premature deaths from cancer or heart disease. In fact, it increased risks.
The JAMA authors also ignored two recent prospective studies Williamson teamed on, one in a 2003 issue of Annals of Internal Medicine and one in the March issue of Diabetes Care which found that people simply improving their eating and exercise habits had lower death rates and rates of diabetes...whether or not they lost weight! In fact, the CDC authors specifically noted they found "losing weight per se was not associated with mortality reduction...[and] weight gainers did not have an appreciably higher mortality rate."
On September 29, ECRI, a nonprofit health services research agency, announced a landmark report evaluating the effectiveness of bariatric surgery for obesity. While they noted the surgeries can produce significant initial weight loss, "three years after surgery, the typical patient is still obese." Most importantly, they concluded that based on the quality and strength of the available evidence, claims of improved "quality of life and long-term health impacts are less conclusive." They found available evidence weak for demonstrating that comorbidities can resolve and "it was also not evident whether bariatric surgery extends survival."
Medical evidence has not soundly demonstrated the effectiveness of weight loss surgeries. Let's hope government officials notice before too many pay the price.
© 2004 Sandy Szwarc. All rights reserved