Junkfood Science: April 2008

April 30, 2008

Government health surveillance — a medical debate you need to know!

Diabetes is a gateway issue... the opening salvo, if you will.

An important debate on the ethical, legal and public health issues surrounding New York City’s creation of a mandatory registry of diabetes patients appears in the current issue of Annals of Internal Medicine. The journal devoted a notable amount of space to this because it is a hugely important issue with enormous, irreversible ramifications for the country.

In the name of public health and allocation of public resources, government agencies are working to seize private medical records on people without their consent to build a database of health indices and behaviors that can be said to “burden employers, insurers and ... touch everyone in our society.” More importantly, this information will be used to monitor how citizens conform to tenuous health indices and how physicians comply with government or third party practice guidelines. This may sound melodramatic, but won’t by the time you’ve read the discussion.

As you’ll remember, two years ago, in response to the “diabetes epidemic,” politicians enacted a NYC law making it mandatory that all laboratories electronically report hemoglobin A1c results (along with the people’s names, addresses and dates of birth) to the state Department of Health and Mental Hygiene for its database of diabetics. This summer, the governmental health department will begin sending letters to people who have what it considers high HbA1c scores, along with treatment recommendations. Physicians will receive daily alerts from the government of their patients who have high HbA1c levels and be given treatment recommendations. It is estimated that this will affect 1-2 million laboratory results each year.

Doctors Benjamin Littenberg, M.D. and Charles D. MacLean, MDCM, identified by the journal only as being with the University of Vermont in Burlington, argued for the registries. Vermont has had a registry of diabetics for several years and tracks HbA1c levels. They opened their article by saying the Chronic Care Model is the best model for “how health care should be delivered” and that one of its central features “is the use of registries to feed back organizational or health care provider performance to improve quality of care.” They explained that registries have a long history in healthcare:

Tracking births, deaths, and infectious diseases allowed the development of the science of epidemiology and supported major public health breakthroughs such as the eradication of small pox. Registry data led to improvements in our infrastructure that rendered cholera and yellow fever rare in this country. Registries for contact tracing are the foundation of programs to curb sexually transmitted diseases and control tuberculosis..

Accurate information on the numbers of patients, their locations, their needs, and the economic impact of their suffering is a necessary ingredient to rational program planning and budgeting by government, insurers, employers, philanthropies, and community organizations. If the scope of a problem cannot be made known, it is difficult or impossible to motivate policy makers, politicians, or the public to action. Certainly, the story of tobacco regulation speaks to the value of accurate epidemiologic data in the face of entrenched forces arrayed against the public interest.

Dr. Paula M. Trief, Ph.D. and Richard A. Ellison, J.D, with the departments of Psychiatry and Medicine at State University of New York, countered by first saying they “agree that registries are highly useful to monitor trends, look for patterns, and provide data for research.” There are already many disease and diabetes registries used for such public health goals, they said, but these have proven that “all of the stated goals can be achieved using deidentified data.”

However, there are very distinct differences between traditional health department disease registries and the radical programs in Vermont and NYC, they stressed. Now, information is being gathered about people without their explicit informed consent, using a passive opt-out procedure, they said. There is no ability for people to opt out of having their personal health information included on the registry. People are “sent a letter that allows them to opt out of being contacted by the Dept of Health,” they explained. If people don’t reply, “they are automatically eligible to be contacted, and in either case their information remains in the registry.” [The opt-out procedure is explained on the NY government website here.] In other words, in order to receive medical care, people are forced to participate.

Of added concern, they said, is that the government uses the information to contact patients and their physicians directly about their health status. They added:

The authors never forthrightly address the significant risks we believe are associated with this opt-out registry, including risks to privacy, to the physician-patient relationship, to potential discrimination, and to patient autonomy. Littenberg and MacLean use the example of tobacco regulation to make the point that epidemiologic data are critical to motivate decision makers. As evidence that subjects are “reassured” of the safety of their information, Littenberg and MacLean point to the fact that in one nongovernmental registry, less than 3% of “subjects” opted out. It is more likely that few opt out because patients (not subjects) often do not attend to, or understand, the opt-out procedure.

We are not dealing with absolutes. The government does not have the absolute right to have all the information it wants, and individuals do not have the right to total privacy. The constitutional law concept of least restrictive alternatives may be helpful here. Under this doctrine, the government may limit individual liberty (privacy) in the face of a public health emergency so long as its intent in doing so is compelling and uses the least restrictive means available.

HIPAA (Health Insurance Portability and Accountability Act) allows the disclosure of protected health information to public health agencies, however this exclusion was made because public health authorities typically deal with communicable diseases:

If we were dealing with a communicable disease that poses a serious health threat to the public (the traditional concern of public health), the government’s interest in obtaining identifiable information would be strong and compelling enough to outweigh the individual’s interest in privacy. However, we are not dealing with a serious communicable disease here. This is the very first time that a disease registry has been developed for a noncommunicable disease like diabetes.

The reality of these mandatory diabetes registries is that the government is assuming oversight over the healthcare decisions made by consumers and their care providers. This was made clear as Littenberg and MacLean went on to write that “registries can be instrumental in assessing the quality of care delivered..[and] support the rational, efficient and effective delivery of care” across the entire population:

Other data sources (e.g. medical records and insurance claims) tend to omit populations such as the underserved or uninsured...Perhaps the greatest good from registries can come when they are used to supplement or enhance services provided by the health care system. By following patients across sites of care and time and feeding back information to providers and patients, registries can improve the timeliness of monitoring and intervention, identify patients who would be lost to follow-up, stimulate better communication between patients and providers, and educate and empower patients.

It goes without saying that those slipping through the cracks and with the most poorly managed diabetes are not getting regular HbA1c levels drawn. But read that paragraph again and ask who they are referring to as doing the monitoring of providers and patients, using registries, medical records and insurance claims? And who is intervening between patients and providers? And, who is determining “quality of care” measures?

Trief and Ellison added that while Littenberg and MacLean suggest that registries can supplement or enhance services provided by the health care system, “they provide no evidence for this claim. Even if such evidence develops, and while this may be an important goal, we believe the means are too intrusive.”

Commentary: Treating numbers

Herein lies the crux of the medical controversy. ‘Quality of care’ and ‘improvement measures’ don’t mean what they sound like. They actually refer to ‘performance measures’ determined by a third party and adherence to them. They are typically based on health indices outcomes (proxy laboratory measures such as cholesterol and blood sugar; and other measures such as blood pressure and BMI) and the assumption that treating numbers to get everyone’s indices down to arbitrary lower thresholds will ensure better clinical outcomes and reduce healthcare costs. But, these measures are considerably more controversial among medical professionals than the public likely realizes or than the evidence supports.

Performance measures are not always supported by sound evidence for improving actual clinical outcomes in patients. JFS has examined the questions surrounding BMI, cholesterol and blood pressure, including the aggressive management of blood sugars to reach low HbA1C levels. As was shown in the United Kingdom Prospective Diabetes Study (UKPDS), the largest-scale study of type 2 diabetic patients in our lifetime and followed them for ten years, tight control of HbA1c levels did not improve clinically meaningful outcomes. The ACCORD trial, which evaluated intense medical management to lower blood sugars, cholesterol levels and blood pressures in 10,251 adult diabetics to see if it reduced heart attacks, strokes and cardiovascular deaths actually resulted in excessive deaths.

What were once clinical care 'guidelines,' developed using the best evidence to assist doctors in their clinical decision-making, have become third-party mandates. The current enforcement of performance measures has been justified mostly using case reports showing changes in “process” and surrogate endpoints, rather than clinical outcomes. Many doctors argue that treating numbers to meet the guidelines can have unintended consequences, especially harmful for significant numbers of people, such as high risk patients, minorities, the obese, elderly and poor.

Yet, these measures now dictate the tests and prescriptions that healthcare providers must follow, and their oversight and enforcement means a third party comes between doctors and their patients — eliminating the ability of physicians to use their clinical judgment as to what is best for each individual patient, his/her situation and comorbidities and wishes. All toll, the “quality measures” in the new performance program recently launched by the Centers for Medicare & Medicaid Services, for example, would encourage some 15 different prescriptions for adults over age 50 in order to meet the requisite health indices.

Public health agencies have a track record of creating public health policies and preventive health programs affecting adults and children that are not evidence-based. The push for government managed care and nationalized electronic databases has similarly shown itself to not be immune to vested interests. And these governmental agencies have already demonstrated that they will apply coercive means to compel compliance with their guidelines, such as cutting reimbursements from healthcare providers and public assistance from the poor.

Evidence-based medicine is the ideal for every patient and involves three critical components that work together, as Dr. David Sackett and colleagues at the NHS Research and Development Centre for Evidence Based Medicine at Oxford, wrote in the British Medical Journal:

Evidence based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. By individual clinical expertise we mean the proficiency and judgment that individual clinicians acquire through clinical experience and clinical practice. Increased expertise is reflected in many ways, but especially in more effective and efficient diagnosis and in the more thoughtful identification and compassionate use of individual patients' predicaments, rights, and preferences in making clinical decisions about their care. By best available external clinical evidence we mean clinically relevant research, often from the basic sciences of medicine, but especially from patient centred clinical research into the accuracy and precision of diagnostic tests (including the clinical examination), the power of prognostic markers, and the efficacy and safety of therapeutic, rehabilitative, and preventive regimens. External clinical evidence both invalidates previously accepted diagnostic tests and treatments and replaces them with new ones that are more powerful, more accurate, more efficacious, and safer.

Good doctors use both individual clinical expertise and the best available external evidence, and neither alone is enough. Without clinical expertise, practice risks becoming tyrannized by evidence, for even excellent external evidence may be inapplicable to or inappropriate for an individual patient. Without current best evidence, practice risks becoming rapidly out of date, to the detriment of patients.

Performance or “quality” measures exclude two of the most important parts of evidence-based medicine: the clinical judgment of the doctor, who must consider the whole patient, and the preferences and wishes of the individual patient. [And this assumes that sound, clinically-relevant research evidence has gone into the development of clinical guidelines in the first place, which very often hasn’t.] As Dr. Sackett and colleagues said: “External clinical evidence can inform, but can never replace, individual clinical expertise, and it is this expertise that decides whether the external evidence applies to the individual patient at all and, if so, how it should be integrated into a clinical decision.”

Patients and their care providers

Getting back to this issue of Annals of Internal Medicine, similarly, Trief and Ellison argued that these mandated diabetes registries that monitor health indices are ineffective and will not benefit people with diabetes. Yet:

The registry will cost approximately $2.3 million per year [just in NYC]. We believe that this money should be used to institute other more effective and less intrusive methods of improving diabetes care and reducing barriers to good care, such as addressing the significant inequities in the health care system...

But, they argued, government registries such as these have far more serious consequences in undermining the relationship between patients and their physicians. They ethically compromise patient privacy and could be dangerous, they said:

One major risk is the threat to the physician-patient relationship. Confidentiality is at the core of the physician-patient relationship. The expectation of privacy and confidentiality enables patients to disclose the most intimate details of their lives for the purpose of receiving appropriate care and treatment... The notification of high HbA1c level from a governmental agency is likely to lead to a breach of trust that could cause patients to avoid medical visits and laboratory tests, thus fostering greater nonadherence and interfering with the physician’s ability to work effectively with the patient.

Assurances that the information will remain strictly confidential and released only to patients and healthcare providers are understandably suspect among the public, given regular reports of privacy breaches of personal health information. But a third risk, they said, is the potential for discrimination should this information be accessed by other agencies, insurers or employers:

We read with heightened concern the authors’ statement that providers, payers, and employers are becoming interested in registries because of the associated “efficiency enhancements.” This is the somewhat frightening scenario we anticipated. As these types of registries become commonplace, employer and insurance groups are certainly going to be interested in them. Does any diabetic patient, especially one with poor glycemic control, want his or her employer or insurance company to have this information?

Their final argument was the most critical to understand, as it highlighted that, while these registries might sound benign and in the public good, they sacrifice far more:

Finally, there is an infringement on the patient’s autonomy, a primary principle of medical ethics. Autonomy is the right of patients to make their own choices about medical care, a right that is especially strong when dealing with a noncommunicable disease. Even advocates of the registry describe it as relying on the “purely paternalistic assumption that patients and their physicians need state supervision...,” assumptions that challenge the patient’s autonomy and reflect a lack of respect.

That attitude of the government knowing better than doctors or patients was seen when Littenberg and MacLean wrote:

[P]rimary care clinicians are not in a position to understand why only 30% of patients with hypertension are achieving their target blood pressure or why only 7% of diagnosed patients with diabetes are on target for all 3 major clinical outcomes (blood glucose, blood pressure, and cholesterol values).

As is clear, blood glucose isn’t the only health index being envisioned for governmental oversight. Trief and Ellison closed by saying that calling them “registries” is disingenuous: “We suggest that we call this what it is, a governmental database of identified diabetic patients who are in poor glycemic control. Still sound benign?”

© 2008 Sandy Szwarc

Revealing: Filling in a few pieces

The significance of the “Chronic Care Model” referred to by Drs. Littenberg and MacLean was likely missed by most readers. It was created in the early 1990s by a project of MacColl Institute for Healthcare Innovation funded by the Robert Wood Johnson Foundation, and was published in 1998. Improving Chronic Illness Care is a national program of RWJF based on this model and is working to change healthcare delivery to an integrated managed care system, and change clinical practice through “quality” measures and protocols focused on intense management of chronic health conditions. This collaborative of departments of health, healthcare delivery systems and stakeholders is sponsored by RWJF and the Agency for Healthcare Research and Quality. The accreditation and certification programs and national guidelines for the management of chronic diseases, as well as provider performance measures (“quality indicators”) under the National Committee on Quality Assurance and the Joint Commission have been based on the RWJF’s Chronic Care Model.

At the 2004 Epidemiology, Biostatistics and Clinical Research Methods Summer Session at the University of Washington, Dr. Edward Wagner, M.D., MPH, director of Improving Chronic Illness Care, said that for them, “chronic illness is defined broadly to include any condition that requires ongoing activities and response from patients and care givers, as well as a response from the medical care system.” Their model, he said, includes traditional chronic conditions, such as diabetes, heart disease, and asthma, but also mental disorders like depression, behavioral disorders like ADHD, addictions, and harmful behaviors like cigarette smoking. He said that over 100 million Americans have some type of chronic condition or behavior that affects work productivity and burdens society, and necessitates changing “the system.”

He cited the same paper in JAMA, which he co-authored, as Drs. Littenberg and MacLean which actually only presented case studies of four managed healthcare organizations using their chronic care model, none of which have fully implemented it — and, as Trief and Ellison noted, have not provided any evidence of improving clinical outcomes. The chronic care model includes increasing compliance of providers to “evidence-based” performance measures, educating patients, changing the design of practices, and new information systems. A third party (i.e. government health agency) is given the authority of monitoring care as it would be given access to patient information, decision support and resources. Registries are key to providing them feedback. Another key component of their model is clinical case management and “intense monitoring of adherence” to guidelines by patients with repeated contacts and reminders.

As Dr. Wagner told audiences: If providers are willing to relinquish some of their autonomy and decision-making, passive patients can be convinced by repeated contacts of their role in managing their conditions.

A few other disclosures may also help readers better understand what’s going on behind this issue. Dr. MacLean is the Project Director of the Vermont Diabetes Information System, which he originated. He is also a consultant to the Vermont Department of Health, the NYC Department of Health and Mental Hygiene, and the Vermont Program for Quality in Health Care.

Dr. Littenberg is a Robert Wood Johnson Clinical scholar and member of the Technical Advisory Panel of the National Quality Forum. This independent nonprofit organization was created to develop and implement a national strategy for “quality measurement and reporting.” Its 27 partners, including government agencies, will be familiar to JFS readers, as identical to those behind the “medical homes” being created to manage your care, clinical guidelines for obesity and other conditions, performance measures for providers, insurer/employer wellness programs, and the creation of a nationalized electronic health database.

He was also co-investigator with Dr. MacLean and together they are recipients of a number of relevant research grants: a $2,031,287 grant (in 2002-2005) from the NIH to implement the Vermont Diabetes Information System, a $266,781 grant (2001-2002) from the CDC on information systems in diabetes care, and a $40,000 grant (2001-2002) on diabetes case management in primary care.

But the most important, and missing, disclosure is that Dr. Littenberg is the Chief Executive Officer, and Dr. MacLean is the Chief Medical Director, of Vermedx™ Diabetes Information System (VDIS). The Vermont and NYC diabetes registries were “engendered based on VDIS” and both registries now contract with VDIS. This electronic communication system takes blood tests from laboratories and pulls out (currently) diabetes-specific lab tests and electronically sends it to VDIS. It generates a flow sheet of A1c, blood lipids (cholesterol), Albumin-to-Creatinine ratio, and creatinine values and compares them to targeted numbers and generates letters sent to patients. If a patient is overdue in setting up an appointment, VDIS sends both the doctor and patient a reminder. It also generates population reports for analyzing compliance with measurement goals.

VDIS was recognized in February by the National Business Coalition on Health and is the largest diabetes registry service available. Last May, it had announced it had been selected by the NYC Department of Health and Mental Hygiene to operate its diabetes registry program. And last month, VDIS signed the multi-year contract with NYC Dept. of Health as part of its initiative to combat what Health Commissioner has “labeled a crisis that is becoming an epidemic.”

Its company media page notes the company’s progress: journal articles identifying “major problems” resulting from lack of managed care and the inability to monitor provider compliance with pay-for-performance measures (“The Vermedx Diabetes Information System uses a proprietary method to overcome these barriers...”); a study by the Department of Health and Mental Hygience claiming that one-third of people with diabetes aren’t aware of it, as well as many with “prediabetes;” VDIS as a model for the NYC diabetes registry; and NYC making diabetes a reportable disease. As its website says: “Vermedx staff have been involved in numerous clinical research projects and have many publications to their credit.” There you’ll also find the groundwork being laid for monitoring blood pressure, cholesterol, depression, health literacy, etc. This summer, they are participating in the plans for national public health surveillance of chronic diseases.

Behind every “epidemic” claimed to need massive government intervention and oversight, you’ll find a lot more going on than objective measures of health problems. Will Americans wake up in time?

© 2008 Sandy Szwarc

(all emphases added)

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April 29, 2008

It’s called cognitive disconnect

Self Magazine recently released the results of an online survey of women’s eating habits and how they felt about their bodies. It reported that 65% of women in America have disordered eating, and another 10% have full-blown eating disorders. In other words, only 1 in 4 women surveyed have some semblance of a normal, healthy relationship with food. Given our culture’s obsession with diet, exercise and body weight, these findings may not be all that surprising, but the more troubling story isn’t in this survey, but what has followed it.

The survey was conducted in partnership with eating disorder professors at the University of North Carolina at Chapel Hill. In a press release, they said that many of the eating habits that women think are normal — such as calorie counting, banishing carbohydrates and ‘unhealthy’ foods, and skipping meals trying to lose weight — can actually be symptoms of disordered eating.

A total of 4,023 women, ages 25-45, responded to the online survey and two-thirds were trying to lose weight, although more than half of the dieters were “at a healthy weight,” said the researchers. Among the other findings they reported, 37% of the women said they regularly skipped meals to lose weight, more than a quarter would be extremely upset if they gained just five pounds and an equal number cut out entire food groups to control their weight. One in six women had dieted by eating 1,000 calories a day or fewer and 13% smoke to control their weight. The researchers reported that 39% of women said concerns about what they eat or weigh interfere with their happiness. The women in their survey also felt extremely guilty if they “indulged” in something “bad” for them.

The degree of unhealthy purging activities among the women, said the professors, was most surprising. More than 31% of the women reported having induced vomiting or taken laxatives, diuretics or diet pills at some point in their lives. “Among these women, more than 50 percent engaged in purging activities at least a few times a week and many did so every day.” Most unsettling, they found just as much disordered eating among the women in their 30s and 40s as in the younger women.

Magazine readers

Are eating disorders and disordered eating behaviors this prevalent among all American women? Or, are women who would choose to participate in an online survey through a woman’s magazine devoted to body perfection, be more likely to already be obsessed with their bodies and diets? Selection bias might lead us to dismiss these findings, especially since we have no information on how the women were recruited and if the poll accurately represents a cross-section of American women. But, what has happened since these results were released, provides more revealing insights into the millions of women who are drawn to these checkout-stand magazines.

Self Magazine, a woman’s magazine specializing in fitness, health, beauty and nutrition, has posted a version of the survey on its website for its readers. Going directly to it (you have to take the quiz) to learn how Self Magazine readers are answering each question reveals that:

· One quarter say they weigh themselves every day, with another 8% weighing themselves two or more times a day.

· An incredible 97.6% say they would be upset if they gained 5 pounds — one third of all the respondents say they’d be moderately upset and 44.1% would be extremely upset.

· For 73% of readers, weight or their bodies play a major role in their lives and how they feel about themselves — nearly 20% feel that their weight and body is the most important thing that affects how they feel about themselves, with another 55% say it plays a significant part.

· More than half of the readers have spent half or all of their time since age 18 dieting. Only 20.76% hardly ever or never diet.

· Unhealthy, unnatural relationships with food, and food fears, are most revealed in the behaviors they admit to having engaged in specifically to control their weight: nearly two-thirds say they have “counted the calories of nearly every single food that went into their mouth,” 44% eliminated entire food groups (namely carbs or red meat), 61% limited the variety of foods they ate, and more than 45% ate less than 1,200 calories/day.

· Nearly 40% follow rigid food rules, such as never allowing themselves to eat dessert.

· And a full 20% are obsessed with thoughts about controlling their food and admit to thinking about food all of the time or several times each hour.

· Unhealthy efforts to control their weight also include: 56% who have skipped meals 44% who have smoked to lose weight

· Bulimic behaviors and efforts to purge calories are seen among more than 22% who admit they have made themselves vomit and two-thirds who have used diet pills or diuretics, another 21% say they’ve used laxatives, and one-third exercise excessively.

Self readers admit to even more disordered eating to control their weight and more concerns focused on their bodies than the UNC survey. Are they attracted to magazines focused on health, beauty, fitness and healthy eating, or might women’s magazines such as these be giving messages that reinforce disordered eating, food fears and unhealthy attitudes and behaviors?

“Healthy eating”

The special feature on disordered eating, “Alarming eating habits,” is highlighted on the magazine's homepage. The sidebar links to an exercise video and stories on Self’s Jump Start Diet, Self’s Diet Club, how to eat healthfully without depriving yourself, and “Get the Facts...to shed pounds...healthy eating ideas, tips for boosting your metabolism, and the skinny on the latest diet buzz in the media.”

The feature story itself links to “Walk your way slim.” It explains how to “supercharge” their steps and add a few smart strength moves to “burn fat, tone muscle and peel off pounds, all in only 30 minutes.” It promises it’s “the easiest shape-up ever!”

The other link on the disordered eating feature is an article entitled, “Healthy eating made simple.” It asks readers if they “want to automatically cut calories and shed pounds?” Citing that restaurant meals are “bad news for your body” because they’re 60% more calories than meals you can cook at home, it offers an “easy-to-stick-to eating plan,” for “healthy meals” with results that include “a slimmer body and extra energy.”

Their article on ‘healthy eating’ goes on to tell readers that dieting can leave them feeling deprived, and that they should budget about 200 calories a day for “forbidden foods” or save up splurge calories for a few days and “blow them all” on a piece of cake. “To keep daily indulgences under control,” they are advised to buy individual servings and stock up on only one type of treat at a time. By limiting variety, it says, they’ll be less tempted to overindulge with abandon. Those 300-calorie frozen entrees are “the fastest way to eat healthfully,” with a glass of skim milk and broccoli. It says the fresh fruits and vegetables are the “stars of any healthy diet” because they’re full of fiber, vitamins, minerals and disease-fighting antioxidants. And cooking at home is important, it says, because you can “automatically cut fat, salt and sugar.”

And, we wonder why so many women have such disordered ideas about “healthy eating”? This is dieting, not normal eating — even as they might believe they are eating “healthy” by restricting fats, meat, sugar and calories. And is it little wonder than thin is widely equated as being a “healthy weight”?

Coincidentally, this survey came out the same day I was stuck in a waiting room with only a rack of women’s magazines and was stunned to see the degree of anorectic models on every page. Thin and fit is becoming thinner with each passing year, with unhealthfully low levels of body fat for grown women. Among a dozen magazines, I found only one image of a normal looking woman. Cover blurbs were all about thin perfect bodies, dieting, burning calories and getting “healthy.” Should it be surprising that 97.6% of women who read these say that a mere 5 pounds would be upsetting to them, that so many women feel fat, and 3 out of 4 think their body weight is the defining factor in how they feel about themselves?

But it goes beyond the images. Disordered eating concerns go both ways. Going back to the Self survey, any woman who admits to ever having eaten something because it tasted good, to soothe stress, or even celebrate a happy event — when their bodies weren’t hungry and didn’t need the calories — was marked off as having disordered eating. The eating disorder professor said such women were “food addicts,” according to MSNBC.

Women who complete the online survey are given a report on their risk for disordered eating. Those who complete it exhibiting normal, healthy eating and relationships with food and their bodies [“weight or body shape is not at all important or plays a small part in how I feel about myself”] and answer “no” to any disordered behaviors are congratulated. They are then told to “continue to focus on the happy dividends of a healthy lifestyle and you’ll have the energy you need...Make eating nutritiously even more enjoyable with ...” — and they are linked to the article on “healthy eating” and the magazine’s “light, delicious recipes.” So, women who just said they weren’t obsessed with their diet and bodies are encouraged to be.

Self Magazine's editor-in-chief said in a press statement that its investigation will help their 5.8 million readers evaluate their own eating habits and if they would be considered disordered. “Recognizing what’s normal and what’s dangerous is the first step all women can take in developing a more positive body image and healthier approach to food.”

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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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April 25, 2008

The loveliest response

This is the loveliest response to a world of prejudice and ignorance that wants to eradicate fat people because they cost too much.

Everyone who feels they don't measure up or are taking up too much space in the world needs to read and listen to this:

How could anyone ever tell you
You were anything less than beautiful?
How could anyone ever tell you
You were less than whole?
- Libby Roderick, "How Could Anyone"

My dearest love,

Yesterday I learned that a vile woman wanted you gone, eradicated from the face of the earth. To to hear that this world would be "more secure and content," supposedly "happier and healthier" without you, without your size in it, fills me with a bitter anger which I cannot contain.

She even set a price on your head, calculating how there would be so much more money if those - you and myself - who foul "their" lovely pristine world by taking up too much space in it, would simply disappear....

[The rest of this love letter is here.]

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April 24, 2008

The compassionate message was lost

Cancer patients became another target of the war on obesity in the cruelest imaginable way when a new study was released this week in Cancer, the journal of the American Cancer Society.

To say that the conclusions of this study and its spin in the news were grossly overstated and bore little resemblance to the actual study, is an understatement.

Before going into detail, let’s put it in the simplest language possible. Physical education and recreation professors took data from the 2005 Canadian Community Health Survey, which included computerized interviews on 114,355 adults who had self-reported if they had cancer or had ever been diagnosed with cancer and what type; their height, weight, age and gender; and how often and long they engaged in leisure time activity (sports, exercises, weight training, yard work etc.) in the past 3 months. The authors calculated the metabolic equivalent task value and labeled as “desirable” amounts of physical activity the equivalent of 1 hour/day of moderate-intensity activity such as brisk walking. They then plotted BMIs and physical activity and looked for correlations between “BMI and participation in various leisure-time activities. That’s it. To put it simply, they were said to have found:

Fat people were more likely to be cancer survivors.

Sedentary people were more likely to be cancer survivors.

This was seen as bad news. They concluded that population-wide interventions were necessary to encourage weight loss and more physical activity in cancer survivors to promote a ‘healthy’ body weight.

But they had just shown that:

Fat people were more likely to be cancer survivors.

Sedentary people were more likely to be cancer survivors.

Their conclusions proposed negating what their own study had supposedly just found.

The press release issued with this study, from which the media took its script, actually condemned fat cancer survivors as being irresponsible for having poor lifestyle habits, because “obesity and physical inactivity are known to be detrimental to health.” [emphasis added] Worse, they reprimanded fat cancer survivors for not changing their ways even after being diagnosed with cancer, saying that “a cancer diagnosis does not appear to prompt significant behavior change.”

Blame is one of the most tragic and hurtful consequences of today’s popular beliefs that eating and living ‘right’ ensures health and helps prevent diseases, such as cancers. Such blame causes pain and anxiety for cancer survivors and cancer patients at a time when they most need support; or worse, could lead them to make diet and health decisions that might jeopardize their health.

This study is the weakest of all types of studies, a data dredge through unsubstantiated and highly selective data looking for correlations. It did not follow a single patient — or even examine a single patient — or make any attempt to verify any information, or learn the cause or time frame for weight gain. It made no effort to gather, consider or adjust for significant known survival measures, such as tumor type or stage. It did not examine a single health outcome to support its sweeping conclusions and recommendations, or for anyone to credibly interpret the correlations. What purpose did this study serve to improve public health or advance our understanding of cancers? Or was its purpose to heighten support for the war on obesity?**

Here are just a few examples of information that wasn’t reported in the news, but can help us see why the news was only worth lining the bird cage.

The claims that everybody “knows” fat is unhealthy and associated with poorer cancer outcomes is not evidence-based research. As JFS readers know, there is no credible evidence to support beliefs that obesity is associated with a greater risk of dying from cancers or of cancer recurrence. In fact, the evidence continues to refute this fear.

Senior research scientists of the Centers for Disease Control and Prevention at the National Center for Health Statistics, for example, recently compiled the mortality data from the National Health and Nutrition Examination Surveys from 1971 through 2000 and U.S. vital statistics on the causes of death. They found: “Our results showed little or no association of excess all-cancer mortality with any of the BMI categories. None of the estimates of excess deaths was statistically significantly different [from null].”

Also recently reported, being fat has not been shown to reduce a woman’s chances of surviving hormone-mediated cancers. The most important factors have been shown to be the grade and stage of the cancer, followed by age at diagnosis.

In actuality, this study was unable to find any tenable correlations between obesity and cancer survival among the cancers they examined (it was another case of splitting hairs) — for ‘obese’ women relative risks (RR=0.88-1.26) ranged from 12% lower (colorectal) to 19% higher (skin nonmelanoma) — for ‘obese’ men relative risks (RR=0.86-1.34) ranged from 14% lower (colorectal) to 34% higher (skin melanoma). All hugging either side of null and within the margin of error and random chance.

In actual proportions of those surviving any cancer at various BMIs compared with matching peers without cancer in the general public, there was a higher percentage of ‘obese’ survivors than those of ‘healthy’ weight. Obesity had 1.2% (for men) to 4.1% (for women) higher rates of cancer survival; ‘healthy weight had a 3.7% (for men) and 5.3% (for women) lower rates of cancer survival. (These were uncontrolled for age, cancer stage, etc.)

But which came first, the weight or the cancer? There’s no way to know from this study. Besides the fact that there is no evidence that being fat spells death from cancer, and plenty of evidence for a survival benefit in many conditions (see Obesity Paradoxes), we could also look at this study’s results in another way.

This study made absolutely no attempt to consider or account for obvious treatment-related factors that result in weight gain and diminished exercising during or after cancer treatments. In any case, this study could have provided a valuable opportunity to give the public sound and helpful information that could increase understanding and compassion for cancer patients and survivors, of all sizes.

For example, according to the National Cancer Institute, weight gain during chemotherapy is especially common for breast, prostate and ovarian cancers; as a side effect for patients given certain chemotherapeutic drugs; and those given hormones. Many anticancer drugs are also given with massive doses of steroids, which can lead to significant weight gain. Anti-cancer medications can also cause fluid retention. In this study, the authors took particular note of fat women breast cancer survivors, without mentioning that women undergoing chemotherapy for breast cancer gain 5 to 8 pounds on average. Some may gain less, while others can gain as much as 25 pounds over the course of their treatments. Blaming cancer patients for the side effects of chemotherapy is beyond heartless.

There are numerous other side effects of cancer treatments that can leave patients with diminished ability to engage in prolonged or intense physical activity. Long-term debilitating exhaustion and need for rest is extremely common as their bodies need time to recover, heal and regain strength. Chemotherapy and radiation treatments can take very hard tolls on the body, damaging the thyroid and affect energy levels and weight, and/or result in heart damage, loss of muscle mass, nerve damage and cognitive deficits. Blaming cancer patients for the side effects of chemotherapy is beyond uncaring. Whether they’re a few pounds heavier is the very least important worry.

Most oncologists, concerned for their patients’ health and wellbeing, in fact, do not encourage patients to try and lose weight. Their bodies are already under incredible stress and need more energy and nutrients to improve their chances for survival.

An additional point is worthy of note: their claim that “fewer than 22% of cancer survivors were physically active at the desired level.” As we learned in a previous post, how physical activity is defined can create a false perception of a group of sloths. These authors’ unusual definition not only included only leisure time activity — disregarding work-related physical activity — but also created a definition of ideal physical activity as 1 hour/day. While it might be understandable that university faculty of physical education and recreation might believe sports and exercise to be the most important activity in life, it is widely recognized (and found in most government guidelines, including the U.S.), that the amount of physical movement offering health benefits is achieved in 30 minutes most days of the week of any moderate activity.

As the authors acknowledged, while the measures aren’t precisely comparable, “our moderately active cutpoint is more comparable to the U.S. studies and showed that about 46% of Canadian cancer survivors were at least minimally active.” Also, not accurately reported in the news, there was “no differences between the cancer survivors as a group and [the general public] in prevalences of physical activity.”

Also not mentioned, is that for most of the cancer survivors, moderate-level activity was associated with greater survival than the high amount of activity that these authors considered as ideally “active.”

The cancer survivors in this study were people. They survived — months to years of biopsies, surgeries, endless tests, chemotherapy, radiation, hair loss, side effects and emotional rollercoasters of fear. They survived. They’re here for those who love them. That’s more important than what dress or pants size they wear or what they look like.

Maybe, there is a valuable message in this study and it’s the cancer patients who can teach us something. After a cancer diagnosis, the fact that they didn’t increase their physical activity to one hour a day may also indicate other priorities proved more important. Maybe, they’ve learned just how precious time is and that the meaning of life isn’t in obsessively exercising and dieting trying to become thin.

Maybe, just maybe, there’s more to life than what we look like.

© 2008 Sandy Szwarc

** All of the study authors worked for universities (University of Alberta and Queen’s University) that are partners in the Canadian Obesity Network (CON). Additionally, Dr. Peter Katzmarzyk Ph.D., is a personal member of CON listed under its experts on the “costs of obesity” and epidemiology. For more information on CON, the lobbying organization for obesity, weight loss and bariatric industry interests, government and policy makers and universities, see here.

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