Junkfood Science: The other side of the story — Part Two

April 27, 2008

The other side of the story — Part Two

When you or a loved one is making a medical decision that will affect the rest of your life, and might even cost you your life, you deserve the best available information based on quality research and balanced, accurate presentations of the medical risks and benefits. Without that, you aren’t able to make an informed decision. Medical news shows may have the look of documentaries and investigative reports on your behalf, and appear to be providing objective and helpful educational information, but always remember. It’s paid entertainment.

Television networks are in the entertainment industry. And when a show — even one that’s the most successful in television history, has all the resources imaginable and has won virtually every broadcast journalism award there is — airs a medical news story, it is entertainment. Yet, how many of the some 13.6 million viewers who tuned in to watch 60 Minutes last Sunday really understood that?

How many believed the story — reporting that bariatric surgeries are wildly successful, safe and can instantly cure diabetes and lower risks for cancer — was giving all the facts? To illustrate how easy it is to lead us to believe something because it sounds right, because experts tell us it is so, and because we think we’ve seen the proof with our own eyes, let’s look a few examples of information that weren’t accurate or supported by credible research. More importantly, a few examples of things left out of the story that offer a balance and give a very different perspective of the actual risks and benefits. It’s a sobering reminder of the importance of thinking critically and not basing any medical decisions on things we see on TV — things that sound too good ... to be true.

Regardless of the decision you make for yourself or a loved one, you deserve to make it knowing both the benefits and the risks.

Miraculous weight loss

Viewers were told that weight loss surgeries have been performed since 1950 and that “it’s pretty well known to doctors that the most successful ‘treatment for obesity’ is surgery, especially the gastric bypass operation.”

Six bariatric survivors were profiled on the show, all reported to have had stunning weight loss of “Biggest Loser” proportions. Between them, they were said to have lost 820 pounds — 136 pounds apiece and in just an average of 7.5 months. That’s more than 4.5 pounds a week, with one gentleman said to have lost 260 pounds in seven months — 9.3 pounds a week!

Did you catch that these patients were only an average of 7.5 months post-op — all within that rosy, period of rapid weight loss called the Honeymoon period, before the well-documented weight regain and long-term complications really set in? How many viewers caught that not a single bariatric surgical patient depicted was 5, 6, 7, 8, 9, 10, 15, 20 ... let alone 55 years out?

When asked how many gain the weight back, a bariatric surgeon, Dr. Neil Hutcher of Richmond, Virginia, claimed to have an 85-90 percent success rate. “There’s no diet, no exercise regimen, and no pill with a success like that,” viewers heard. “These patients lose a ton of weight and keep it off.”

According to Dr. Hutcher, “when you’re dealing with an incurable disease that kills people [referring to fatness]...that’s pretty darn good.”

Viewers were left to believe anecdotal evidence — they could see the wondrous weight loss with their own eyes, so it must be true. Such results also appeared typical — after all, every single patient presented enjoyed similarly impressive results. By then, viewers were so fired up by the promise of magnificent weight loss that surpassed the effectiveness of any diet, exercise or pill, few probably noticed that no evidence was provided.

Viewers didn’t hear: No randomized, clinical trial has ever been published — by anyone — to support such extraordinary claims. In fact, every study to date, regardless of the weight loss procedure, has shown weight regain is the norm.

Dr. Neil Hutcher, while only identified by 60 Minutes as being a doctor from Richmond, is actually the Senior Past President of the American Society of Bariatric Surgeons, the trade and lobbying group for bariatric surgeons.

Only a brief mention was made later in the show that most bariatric survivors don’t get skinny. Although that was quickly countered when Dr. David Cummings, an associate professor at the Division of Metabolism, Endocrinology and Nutrition at the University of Washington in Seattle, said that while most patients “do not become fully ‘normal’ in terms of body weight... it’s an enormous change.”

Later in the show, the patients talked about how the surgery removed their enjoyment of the foods they once loved, from cheeseburgers to desserts. That was presented as a good thing and the implications were never explained. Viewers were told the surgeries took away all sensations of hunger because it was believed to suppress the hormone grelin [sic], helping them to eat less and reinforcing the belief that obesity was due to overeating.

Viewers didn’t hear: Ghrelin was only first discovered and named in 1999 by Japanese researchers, Masayasu Kojima and colleagues at Kurume University, who originally thought it acted on growth hormone secretion and later found it circulating in the blood and in the stomach. It is one of some two dozen hormones and other chemicals that are currently believed to work together to regulate food intake and metabolism, but no one is sure precisely how or where they originate.

Dr. Cummings and colleagues had shown in the October 2002 issue of Endocrinology that in normal-weight people, a spike in insulin secretion occurs after eating, and corresponds with a dip in ghrelin production. In gastric bypass patients, ghrelin’s fluctuations appear suppressed, leading to speculations it might contribute to weight loss. Ghrelin was later found to not work the same way in fat people.

In a 2005 article in Newsweek [archived here] on a ghrelin antagonist pill being developed by a Swiss biotech pharmaceutical company, Dr. Cummings said it was still not clear that blocking ghrelin’s action would lead to weight loss because most fat people have low levels of ghrelin. “Further lowering it may not help,” he said. “Ghrelin is not the underlying molecular cause of obesity,” said Dr. Cummings, who was identified as a consultant to Abbot Laboratories. “We haven’t figured out the underlying cause yet.”

Scripps Research Institute has been investigating it as a weight loss vaccine in rat studies, as published in 2006. But, as Dr. Marc Jacobson, an obesity expert at Long Island Jewish Medical Center was quoted by Newsweek as saying, ghrelin is one of many different hormones that regulate our weight and “even if a vaccine wipes out this hormone’s effect, there may be others that reverse any effect you get.”

Last year, in the Journal of Clinical Investigation, Dr. Cummings and colleague Dr. Joost Overduin, described some of the emerging theories for potential targets of weight control, highlighting how much less understood, more complicated and unresolved the science is than 60 Minutes led viewers to think. Drs. Cummings and Overduin, in the first sentence of their review, however, did explain what is known, essentially describing set-point and that it isn't food intake that explains the natural diversity of sizes in people, hopefully removing the blame surrounding obesity and people’s belief that their ‘overeating issues’ caused their obesity: “Despite substantial fluctuations in daily food intake, animals maintain a remarkably stable body weight, because overall caloric ingestion and expenditure are exquisitely matched over long periods of time, through the process of energy homeostasis.”

Safe and nearly complication free

From the opening, Leslie Stahl, moderator of the 60 Minutes special, assured readers that bariatric surgeries are much safer today. They’re done laparoscopically now, she said, using “tiny surgical tools.” She told viewers that according to Dr. Hutcher, today only about one in 1,000 people die from this operation, making it less deadly than most major surgeries. “It's less than gall bladder surgery. It's about one-tenth of cardiac surgery,” said Dr. Hutcher.

And what about possible complications and other risks? “Several existing studies point to one risk,” said Stahl. “I’ve seen some studies that say that suicide rates go up among patients who have this operation,” she said. But, “the positive side effects continue to accumulate.

That was the only mention of risks or complications.

Absolutely no source was provided for these claims of extraordinarily low mortality rates, nor was there even a mention of the more than sixty complications and their frequencies that have been widely documented in the medical literature.

Viewers didn’t hear: The largest, strongest and most comprehensive examination of death rates after bariatric surgeries was published last October in Archives of Surgery and reviewed in detail here. Because this study looked objectively at an entire population of patients, not just those surgeons selectively chose to report on or hadn’t lost in follow-up, it avoided selection bias. The reliability of its findings were emphasized by Dr. Edward H. Livingston, M.D., of the Department of Gastrointestinal-Endocrine Surgery at the University of Texas Southwest Medical Center in Dallas.

The researchers looked at the data on every bariatric surgery done in the entire state of Pennsylvania for a decade and followed the cumulative deaths from surgery. They found that nearly 3% of all patients had died after the first year and 6.4% of the patients were dead by the end of the fourth year after their surgeries. And long-term mortality proved even more unsettling:

For the 1995 cohort who had at least 9 years of follow-up, 13.0% had died. From the 1996 cohort with 8 years of follow-up, 15.8% had died, and from the 1997 cohort with 7 years of follow-up, 10.5% had died. For the 1998-1999 cohorts with 5 to 6 years of follow-up, the total mortality was 7.0% to 2004.

These death rates were compared to actual U.S. National Center for Health Statistics of the Centers for Disease Control and Prevention data on matching Americans of the same age and BMI. By best estimates, bariatric surgeries likely increase the actual mortality risks for these patients by 7-fold in the first year and by 363% to 250% the first four years.

Two other population-wide studies examining mortalities among bariatric patients, both found disturbingly high mortality rates. These studies were readily available to 60 Minutes. As Dr. Livingston wrote, the high mortality rates evidenced in these objective studies “called into question the risk-benefit ratio for operations.”

According to Dr. Hutcher, 20 million Americans are eligible for bariatric surgery and could benefit. Yet, less than one percent were getting it.

Based on the most objective available evidence to date, if everyone eligible got the surgery, nearly 1.3 million people would be dead 4 years later. Yet, all of them would likely still be alive had they not had the surgery.

CBS wasn’t able to have any of these bariatric patients on the show because they aren’t with us, but for balance, 60 Minutes might have had the families and friends of a few, to describe their loved ones and the suffering that led to their deaths.

Putting the risks of bariatric surgeries, regardless of the procedure, into perspective, shows they are considerably riskier than any other elective surgery. Overall post-op deaths from a hysterectomy among American women, for instance, is a mere 0.19%. Coronary artery bypasses are one of the most dangerous surgeries performed and are typically done on older patients, 75 years of age, on an emergency basis after a heart attack or other life-threatening event. Bariatric patients are comparatively young and healthy. Yet, the risk of dying from coronary bypass for the most obese man (BMI >36) is 1.3%, according to Dr. Paul Ernsberger, Ph.D., at Case Western Reserve School of Medicine, Cleveland, Ohio.

Nor were complications accurately portrayed, let alone even mentioned on television. The absence of bariatric survivors with any problems might easily have left viewers to think the complications were not worth mentioning. But, in fact, complications are extensive and more common than popularly believed.

For example, in 2000, the Mayo Clinic reported 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. A recent study by researchers at Virginia Commonwealth University found that 56% of bariatric patients had 62 different gastrointestinal complications and abnormalities by CT scans. The complications and failures of bariatric surgeries are so significant, according to bariatric surgeons with Tampa General Hospital in Florida, that revisional (second) surgeries are required in up to 23% of gastric bypasses and 5 - 36% of vertical banded gastroplasty cases. Their 2007 paper in Bariatric Times said revisional surgeries now account for nearly 15% of the bariatric procedures being done in experienced bariatric centers. Vomiting after gastric bypass procedures occurs in up to 68.8% of cases and can become chronic, resulting in severe malnutrition, according to Brazilian surgeons in a 2005 study published in Obesity Surgery. Because both the stomach and small intestines are critical for absorbing many nutrients, including B-vitamins, calcium, iron, vitamin D and protein, malnutrition and neurological decline seen after bariatric procedures, including lap bands, are not uncommon, according to the National Institute of Diabetes and Digestive and Kidney Diseases, and include anemias, osteoporosis, loss of teeth, blindness and, in a reported 16% of cases, even neurological and brain damage. The health and nutritional consequences for teens, reviewed here, are even more troubling.

In fact, the complication rates are so high and the complications so severe that even Dr. Edward Eaton Mason M.D., Professor Emeritus of General Surgery at University of Iowa Hospital and the inventor of gastric bypass, 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.”

While CBS television viewers were kept in the dark about risks and complications, we would hope that patients are being given a much more realistic and complete picture when they seek information, especially from their surgeons.

Going to Dr. Hutcher’s surgical website at Commonweath Surgeons, Ltd., for example, brings a greater understanding and compassion for these patients. “Overall complication rate for this surgery nationally is about 10%,” it says. Only four complications are listed on the page of complications [Click on image to enlarge]: Nausea, vomiting, bloating and/or heartburn are attributed to patients eating incorrectly. The dumping syndrome is said to be avoidable if the patients don’t eat sweets and take fluids. Blockage of the stomach is attributed to patients not chewing food correctly. And ‘overeating’ is listed as the final complication, attributed to patients not following the eating instructions. The patients, rather then the procedure, are blamed for problems.

Obesity is deadly

The 60 Minutes episode went to great lengths to frighten viewers that “being fat give(s) you cancer,” and cite a long list of cancers linked to obesity. The show claimed 100,000 people in the U.S. die of cancer because of their weight and that bypass cut cancer risk in half.

These unsupportable claims have been covered at JFS extensively, so we’ll move on.

Costs and availability

“The bypass operation costs an average of $25,000 and insurance companies don't always cover it,” said Ms Stahl. Most doctors still consider it an operation of last resort, but Dr. Hutcher wanted to see the clinical guidelines for eligibility changed so that more people could get the surgery. “Under guidelines written by the National Institutes of Health 17 years ago in 1991, only the severely or morbidly obese are eligible for any bariatric operation. If you're just mildly obese, you can't get it. And a lot has changed since 1991,” he said.

No longer needing any medications for blood pressure, cholesterol and blood sugars was another benefit claimed on 60 Minutes, with one bariatric survivor saying “I’m off all medicine.” The television show failed to put this into perspective, but viewers could only assume that this was the norm. One bariatric survivor was a doctor who said he hands out his surgeon’s cards right away to fat people and doesn’t wait for health problems to develop, implying that bariatric surgery prevents health problems.

Viewers didn’t hear: The guidelines for the clinical application of laparoscopic bariatric surgery of the Agency for Healthcare Research and Quality under the U.S. Department of Health and Human Services were released on July 2003 and “have been updated.” The summary completed by ECRI on March 22, 2004 can be seen here.

The myth that bariatric surgeries are inexpensive and save healthcare costs was covered here. By citing only the costs of initial surgeries and not including the costs for the average readmissions for surgical complications, the costs are frequently underreported. Pennsylvania, for example, examined the actual hospital costs for bariatric patients across the state in 2001, and found that 39% of patients required readmission and the total average hospital costs alone were more then $44,000 each.

The oft-repeated claims that, on balance, surgeries prevent actual health problems and reduce later healthcare expenditures have never been supported in careful studies. In fact, hospitalizations more than double for most patients after having the surgery. A 2005 study of nearly 61,000 patients who had gastric bypass in California from 1995 to 2004, for example, found that 19.3% were hospitalized during the year following their surgeries, mostly for surgery-related complications, such as infections, hernias and bowel obstructions. Most notably, their hospitalizations after bariatric surgeries were more than double the 7.9% hospitalization rate the year prior to having the surgery. A subset followed for three years showed their hospitalization rates were 18.4% during the second post-op year and 15% in the third year, still much higher than they ever were before their surgeries. Bariatric surgeries clearly do not mean better health for most patients.

Nor are the claims of fewer overall medication needs supported in the medical literature. Medications for blood sugar or blood pressure are exchanged for others. Even the Swedish SOS study reported in 2001 that the surgeries did not result in cost savings among the patients. They found that “the use and cost of drugs in obese patients to be about the same, whether or not they had the surgery. Those who didn’t have the procedure needed medication for diabetes and cardiovascular disease, while those who underwent it needed treatment for gastrointestinal-tract disorders, anemia and vitamin deficiency.”

Instant cure for type 2 diabetes

The most “dramatic effect” for gastric bypass operations, said Ms Stahl, is that “it can force type 2 diabetes into almost instant remission.” The bariatric surgery survivors on the show all said they had diabetes before their operations and none have diabetes now. “That means they no longer need sugar-control medication,” she said. A patient was shown being wheeled out of surgery while Ms Stahl said that before any weight is lost, the blood sugar levels were down to normal.

According to Dr. Hutcher, not just in terms of weight loss, the operation itself can take type 2 diabetes and throw it into complete remission. “I think my patients are cured,” he said. “They go home on no medications, and I’ve followed them now for 10 and 15 years, and see no evidence of recurrence. So, it’s pretty darn close [to a cure].” But, as Stahl pointed out, under the current guidelines you can’t get bariatric surgery if you’re not ‘morbidly obese’ and Dr. Hutcher wants to see the guidelines changed. “I think we have clear cut evidence that we can do terrific things for diabetics,” said Dr. Hutcher.

The “spontaneous remission” of diabetes puzzled Italian surgeon, Francesco Rubino, now at New York Presbyterian Weill Cornell Medical Center, said Stahl. Dr. Rubino believed it might have something to do with the small bowel, so he began doing bypass surgeries on diabetic rats and found that blood sugars dropped when the duodenum was bypassed. “This meant diabetes could essentially be removed with a scalpel,” viewers were told. 60 Minutes then went to Sao Paulo, Brazil, where they’re beginning to test the “diabetes surgery” on diabetics who aren’t fat.

Viewers didn’t hear: When you stop eating, eat insufficient calories, or suffer from malabsorption, what happens to your blood sugars? They drop, of course. Does that mean the underlying disease pathology of diabetes has been cured? Of course not. Blood sugars are a symptom, a health index, not the disease of diabetes itself.

Dr. Rubino and colleague Dr. Jacques Marescaux, M.D., FRCS at the University Louis Pasteur in France, wrote in the 2004 issue of Annals of Surgery that claims “a direct antidiabetic effect of bariatric surgery had already been demonstrated ... is not supported scientifically.” As they explained:

First, a small, uncontrolled case-series type of study is not the proper instrument to demonstrate a direct effect of surgery on type 2 diabetes (T2D) as there are several possible reasons that could justify improved glycemia after a bariatric operation. For instance, since patients undergoing Roux-en-Y gastric bypass (RYGB) or biliopancreatic diversion eat small, rather fluid and low-caloric meals in the early postoperative period, it is admittedly impracticable to rule out that the rapid normalization of plasma glucose and improved insulin resistance after these surgeries be simply the effect of decreased caloric intake. Although several independent observations documented rapid remission of T2D after RYGB and BPD, all these studies had not been designed to specifically test the efficacy of surgery as a treatment of T2D.

There has been no sound, randomized controlled clinical trial to show any bariatric procedure to cure diabetes or do more than lower blood sugars for some percentage of patients and outweigh the risks.

This confounding factor raised by Dr. Rubino, and the problem of trials not designed to be fair tests of an intervention, is also seen in lap band procedures being recently cited as effective for diabetes. Bariatric surgeons at the University of Obesity Research Center in Australia published a study in the Journal of the American Medical Association in January, reported in the news as showing strong evidence that lap band surgery resulted in remission of type 2 diabetes. This short-term trial on 60 moderately obese patients with recently diagnosed diabetes, however, merely showed blood sugars were lowered relative to the degree of weight loss. It wasn’t of sufficient duration to show that once patients began eating normally, that the effects on blood sugars were maintained. “An important finding of this study is that degree of weight loss, not the method, appears to be the major driver of glycemic improvement,” they wrote. The “long-term efficacy” needs to be assessed, they concluded.

Certainly, the gastrointestinal tract plays an important role in energy metabolism and that a multitude of hormones found in the stomach and intestinal tract are involved in the regulation of blood sugars. So, “it should not surprise anyone that surgically altering the bowel's anatomy affects the mechanisms that regulate blood sugar levels,” said Dr. Rubino in the March issue of Science Daily.

But is this a cure for diabetes, or merely taking a sledge hammer approach to blood sugar management?

By a show of cyber-hands, how many watched the 60 Minutes special and came away believing that it was a slam dunk and had been proven that “diabetes goes away” instantly with gastric bypass and patients can “dump their pills” forever? Since this is such a hot issue, it might be worth taking some bandwidth to explore. Every surgeon has his/her own idea of what works and why, and has his/her own unique procedure. What is most striking in reading the current debates is how little anyone yet fully understands how the various hormones in the gastrointestinal system function, independently or together, let alone the long-term effects of impairing or altering their function.

Never the less, the bariatric industry is going full steam ahead to expand the surgeries beyond the treatment of obesity and convince the public and healthcare professionals that surgery is a treatment for metabolic conditions, including type 2 diabetes, hypertension and high cholesterol, based on changes in these surrogate indices — changes that occur during undereating, starvation or malabsorption and have not been separated from them in trials. Simultaneously, the adverse effects of malnutrition and malabsorption of nutrients that accompany surgically altering the gastrointestinal system, as well as the gut hormones, are downplayed or disregarded.

In March of last year, Dr. Rubino organized a Diabetes Surgery Summit in Rome, which founded the field of ‘diabetes surgery’ and created the International Diabetes Surgery Task Force. Dr. Rubino serves as a founding member. This was followed in August by the Bariatric Surgical Society changing its name to the American Society for Metabolic & Bariatric Surgery, in order to promote its new mission of marketing bariatric surgeries as treatments for diabetes and other metabolic conditions, and to make diabetes surgery a new surgical discipline. According to the press release, this trade organization has nearly 3,000 members, all stakeholders in bariatric surgery.

Coincidentally, the claims made in this press release appear to have been heavily relied upon by 60 Minutes.

Then in November, New York-Presbyterian Hospital/Weill Cornell Medical Center announced it had created the first academic medical program dedicated to diabetes surgery, called Gastrointestinal Surgery, and had appointed Dr. Rubino to head it. Dr. Rubino is the proponent of a new procedure he invented which bypasses the duodenum, called the Rubino Procedure, according to the press release. “He reported that the procedure dramatically reduced diabetes in animals — demonstrating for the first time that surgery has a direct effect on type 2 diabetes,” it said.

Dr. Rubino told Science Daily last month that gastric bypass of the upper small intestine actually “does not improve the ability of the body to regulate blood sugar levels.” In fact, he said, when performed on nondiabetics, it appears to impair the mechanisms that regulate blood sugar levels, but not on diabetics. This has led him to believe that the upper intestine is a site where some abnormal signal is produced, and is the rationale for his procedure. No randomized clinical trial of this experimental procedure on humans has yet been published, however.

Writing in Annals of Surgery, he and Dr. Mareascaux said that their test of duodenal-jejunal bypass in diabetic animals “strengthens the hypothesis that an endocrine effect be involved...but does not explain yet what exactly makes this effect possible.” As they wrote: “[I]t remains unclear which hormone response induced by DJB is determinant in the control of T2D. It may be either the production of a “protective” factor enhancing insulin sensitivity and/or insulin secretion or the suppression of a gastrointestinal signal produced in the duodenum-jejunum and causing insulin resistance or strictly involved in its pathogenesis.”

One possible candidate for this hypothesis, they said, is GLP-1, an incretin hormone that enhances insulin secretion. However:

[W]hereas increased GLP-1 levels have been reported after jejuno-ileal bypass, more recent studies consistently failed to demonstrate significant GLP-1 changes after RYGB. Hence, we would be more cautious... in considering the changes in GLP-1 as the hormonal mechanism by which DJE controls T2D; at least until more evidence becomes available. In contrast, several studies consistently showed that glucose-dependent insulinotropic polypeptide (GIP) levels fall shortly after RYGB and we think this has potential implications in surgical control of T2D. Reduced levels of GIP may be a downstream effect of one or more other coordinate hormonal changes that improve insulin sensitivity/secretion...

Might GIP resistance be reversed by surgery, independent of weight loss, to support bariatrics in diabetics who aren’t fat? One clinical trial was found registered (NCT00207389) that was designed to test this hypothesis and examine changes in GIP levels, as well as other gut hormones, with gastric bypass surgery in patients with type 2 diabetes. This pilot intervention clinical study compared serum levels of a variety of peptides and hormones, including GIP, before and after gastric bypass (bypassing the stomach, duodenum and jejunum) before weight loss occurred. Begun in March 2004 at Boston University Medical Center and estimated to be completed in March 2005, the trial was suspended and the results never published.

Without getting into the minutia of each bariatric surgeon’s arguments for and against various bariatric procedures, the take home message is that altering the stomach and intestinal tract has effects on hormones that are not fully understood or proven. Dr. Cummings, writing in the July 2005 issue of the New England Journal of Medicine, said that “large (up to 10-fold) and durable (up to 20-year) elevations of GLP-1 or other nutrient-stimulated L-cell hormones, including peptide YY and enteroglucagon, have been documented after Roux-en-Y gastric bypass, biliopancreatic diversion, and jejunoileal bypass surgery.” Operations that expedite the delivery of food to the hindgut should increase GLP-1 secretion, resulting in heightened insulin production and lowering of blood sugar, he said.

But there is a significant and growing concern among bariatric experts, as well as building evidence, of adverse effects resulting from interfering with these hormones. And consumers deserve to learn about them.

Dr. Mason has been describing and cautioning about this for many years. Writing in IBSR Newsletter from the University of Iowa, he said that bypass operations not only restrict food intake, they also cause malabsorption. But, in addition, they cause food that hasn’t been digested to reach the distal small bowel, stimulating the (ilieal brake) hormone GLP-1 to be secreted, which interferes with the normal regulation of insulin secretion. It stimulates the beta cells in the pancreas to grow and produce more insulin, and this continual stimulation of the pancreas can result in an overgrowth of cells (hyperplasia) in the pancreas and islets.

What he is referring to is nesidioblastosis, a previously extremely rare disease of the pancreas that is usually seen in newborns and results in severe hypoglycemia uncontrolled with diet and leads to brain damage, retardation and death. It usually requires (all or partial) removal of the pancreas, although hypoglycemia can persist even then, resulting in permanent insulin-dependent diabetes.

Healthcare professionals and consumers have become so accustomed to fearing high blood sugars, that low blood sugars are rarely monitored in fat people. Nesidioblastosis has been described in growing case reports of gastric bypass patients. Recently, the most notable one was in the July 2005 issue of the New England Journal of Medicine. Dr. Geoffrey Service, M.D. and colleagues at the Mayo Clinic in Rochester, MN, and experts in the field of hypoglycemic disorder, described 6 patients, with an average age of just 47 years, who had been referred to them for severe hyperinsulinemic hypoglycemia that couldn’t be controlled by dietary changes.

They said that just in the past five years, 40% of the confirmed cases of nesidioblastosis they’d seen at Mayo had occurred in persons who had undergone Rouxen-Y gastric bypass surgery, whereas less than 0.1 percent of the general population has had this procedure. In other words, nesidioblastosis is seen in gastric bypass patients 400% more than in the general public.

While not proof of causation, growing evidence supports it, said Dr. Cummings and colleagues at the University of Washington in the November issue. “Nesidioblastosis is extremely rare and almost never develops in adulthood,” they wrote. And to see confirmed cases increased by a factor of 400 in bypass patients is a grave concern.

“Another group has subsequently published similar findings and we know of two additional centers with parallel observations,” they wrote.

However, according to Dr. Cummings and colleagues writing in the November issue of the NEJM, GLP-1 itself is increasingly believed to not be the dominant causative factor, as it doesn’t stimulate insulin secretion without concomitant hyperglycemia, suggesting other factors play a role. The science is just beginning to sort it all out.

In October 2005, a study by researchers at Joslin Diabetes Center, Beth Israel Deaconess Medical Center, and Brigham and Women's Hospital in the journal Diabetologia reported three gastric bypass patients suffering Nesidioblastosis and they told doctors to be on the alert for severe hypoglycemia as a complication of bariatric surgeries. Only after they’d submitted their paper to the journal did they learn of the NEJM report by Dr. Service and colleagues. In the Diabetologia paper, one patient, for example, was a 27 year old woman who had been healthy, but had post-op complications requiring an exploratory surgery and conversion to a RYGB. Her health continued to worsen with severe hypoglycemia unresponsive to foods or medical interventions. It resulted in loss of consciousness and a motor vehicle accident. A 45-year old man also had severe post-op complications requiring surgeries also had hypoglycemia resulting in a motor vehicle accident. And a 66 year old woman’s hypoglycemia, also unresponsive to medical management, resulted in falls, loss of consciousness and seizures.

Case reports in medical journals continue to build, even as recently as the January issue of World Journal of Gastroenterology. There, researchers reported on a 71-year old man with nesidioblastosis after a gastrectomy two years earlier. But, based on the volume of bariatric survivors in patient support groups and on various bariatric forums discussing problems with intractable severe hypoglycemia and nesidioblastosis, I suspect that the problem is much more widespread than is recognized and being written up in case reports for medical journals.

In response to growing reports of nesidioblastosis in gastric bypass patients, Dr. Mason had written in ISBR back in 2005 that “what may be a rare complication can become too frequent in absolute numbers when treating an epidemic with the projected 200,000 RYGB operations for 2006.” When nesidioblastosis occurs, a life-saving pancreatectomy is usually required. If the entire pancreas is removed, permanent insulin dependent diabetes results. “Surgeons need to prepare for the time when there may be sufficient reason for no longer using bypass operations,” he wrote. “RYGB causes weight loss but also loss of many important body regulatory systems that keep a normal person healthy. Lifelong medical care following gastric bypass is expensive and difficult to obtain, but it is necessary.”

Managing blood sugars in type 2 diabetes by addressing incretin hormones and the GLP-1 pathway and promoting pancreatic islet growth is how diabetes medications like Byetta and Januvia work. But no one would say that these medications helping to control blood sugars are “cures” for diabetes or that the patients are no longer diabetics. As Dr. Cummings and colleagues wrote, the risks with a medication are far less than those that accompany bariatric surgeries — including the complications resulting from destroying the ability of the gastrointestinal tract to properly absorb nutrients, as well as the surgical complications. At least with a drug, should a problem like nesidioblastosis occur, it’s far easier to resolve by discontinuing the drug, than trying to reverse the bypass surgery, they said.

While 60 Minutes may say bariatric surgeries have been shown to instantly cure diabetes, reality outside of television-land is a far different story.

More importantly, good medical care doesn’t focus on potential benefits for a single health index and ignore the bigger picture. The objective demonstrations of higher death rates following bariatric surgeries, regardless of the procedure, must be weighed against interventions with credible evidence of effectiveness for improving real health outcomes. People entrust that healthcare professionals have balanced sound benefits with the risks. “Our treatment works, but the patients die,” isn’t very convincing proof of efficacy.

Is the chance for temporary weight loss worth any price? To make a truly informed decision, people deserve to hear the full story. That can be hard to find. These surgeries alone will bring in around $9.7 billion in the U.S. for surgeons this year, providing an extra incentive for intense marketing of their benefits.

With any medical decision, and especially for this one which has life-long repercussions, it is critical to understand what makes a “fair test” of a clinical intervention and to carefully and critically examine the evidence. We won’t find that on television.

© 2008 Sandy Szwarc. All rights reserved.

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