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Obesity and Essential Health Benefits: The Final Rule

February 21st, 2013

The Department of Health and Human Services issued final regulations defining “Essential Health Benefits” which will have to be included in insurance programs listed on state exchanges and all non-grandfathered health insurance plans in the group and individual markets. The EHB covers 10 categories covering hospitalization, prescription drugs, etc. See Fact Sheet.

The regulation is generally close to the proposed regulation with the exception of expansion of mental health, habilitative care and pediatric dental and vision services.

Last July, interim final regulations were issued which require these plans to include under prevention and wellness, the US Preventive Services Task Force recommendations, which include Intensive Behavioral Counseling for Adult Obesity.

Unfortunately, it appears that HHS has no problem with allowing most state exchanges to use “benchmark” plans which exclude bariatric surgery, according to a report by the Obesity Care Continuum. Coverage of prescription medicines for obesity is murky. The EHB regulations state that plans must provide at least one drug in each category or class of the US Pharmacopeia. But it uses version 5.0 for Medicare. Under the Medicare statute, Part D, drugs to treat obesity are excluded so they don’t appear to be covered. However, this might be challenged under the EHB rules that the benefits must be designed in a manner which does discriminate based on age, disability, or expected length of life and must take in the needs of a diverse population.

The regulations limit deductibles to $2,000 for individual coverage and $4,000 for family coverage.

The STOP Obesity Alliance and my own comments, had argued for more clarity in the inclusion of obesity treatments.

 

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Posted in DAILY DOWNEY, ECONOMICS, Health Care Reform

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Obesity Related Hospitalizations Soar

December 4th, 2012

Obesity-related hospitalizations have tripled from 1996 to 2009. In 2009, there were approximately 2.8 million hospital stays for which obesity was either a principal or secondary diagnosis. The share of obesity-related hospitalizations increased from 3% of all stays (excluding infants and maternal) in 1996 to more than 9% of all stays in 2009. Hospitalizations in which obesity was the principal diagnosis increased 13-fold from 10,100 in 1996 to 132,900 in 2009.  Hospitalizations in which obesity was the secondary diagnosis increased from 766,600 in 1996 to 2,716,200 in 2009, a 3.5 fold increase.

Mean cost per stay for hospitalizations with obesity as a secondary diagnosis compared to no-obesity relationship was 9% higher in 2009 over 2004. Overall, hospital stays with any mention of obesity accounted for $33.4 billion (10.2%) of aggregate hospital costs in 2009.

The most common procedure for which obesity was the principal diagnosis was bariatric surgery, which was unchanged from 2004.

The most common procedure for which obesity was the secondary diagnosis was osteoarthritis, increasing by 27% from 2004. Coronary atherosclerosis was the most common principal diagnosis accounting for 6.8% of all stays in 2004. It decreased 37% to become the third most common diagnosis in 2009. Chronic obstructive pulmonary disease and bronchiectasis increased 34%, rising from the 14th most common procedure to the eighth.

The report is based on HCUP database, sponsored by the Agency for Healthcare Research and Quality. AHRQ: Adult Obesity Hospitalization Statistical Brief 137

 

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Look AHEAD Crashes

October 22nd, 2012

 

Behind Look Ahead

The National Institutes of Health (NIH) has announced that the Look AHEAD trial has been stopped in its 11th year, two years short of completion. The extensive trial, involving over 5,000 patients at 16 centers, was intended to find out if there was increased mortality from intentional weight loss and to see if intentional weight loss among obese patients with type 2 diabetes would result in fewer cardiovascular (CV) events. At the end of the trial, there was no difference between the study group, which received intensive behavioral counseling and the control group which received standard diabetes education and occasional support group meetings.  The NIH press release indicates that both arms had lower CV rates that reported for patients with diabetes in previous studies. NIHNEWS: Weight Loss Not Reduce CV events in Type 2 diabetes

While this is news is something of a shock, many folks saw it coming. Two years into the trial, which began in 2001, the monitoring board noticed that the event rate in the control arm was much lower than expected. The expected CVD event rate in the control arm was 3.125% per year; in fact it was 0.7%. A committee was formed and made changes to the original study protocol designed to capture more events. These changes went into effect in 2008. There appeared to be three reasons for the lower event rate. First, while cardiovascular disease (CVD) is still the major cause of death in the United States, mortality has gone down, resulting from better control of dyslipidemia and high blood pressure and improved care of chronic and acute coronary syndromes. (See NCHS Data Brief, NCHS DataBrief: Prevalence of Uncontrolled Risk Factors for CVD)  Second, study participants who choose to involve themselves in a long clinical trial may well be healthier than a community sample and more motivated to follow the diet and exercise and participation requirements. Finally, the Look AHEAD trial employed the Graded Exercise Test which excluded participants most likely to develop CVD. Because of the low event rate, an additional primary endpoint was added (hospitalized angina) and the trial was extended for 2 years. (See PubMed: Brancati_Midcourse Correction to clinical trial whe the event rate is underestimated: the Look Ahead Study) Readers may recall that the SCOUT trial of sibutramine also had to revise its protocol midway through the study for the same reason, resulting in a population which was older and sicker than typical clinical population. In both cases, revising the protocol did not favor the intervention.

The stopping of Look AHEAD raises a host of questions. Was the study protocol correct? Did it end up studying healthy obese diabetics? Do long-term studies produce more noise than insight? Are we really studying the aging process when we cannot control for changes in health status, drug utilization (including drugs which can increase weight) and changes in energy intake, fitness levels, etc.? What is the picture for sub-groups, such as the 60-74 age group which had good weight loss in the DPP and 4 year results of Look AHEAD? Were there specific improvements, such as reductions in medications usage, fewer hospitalizations or shorter length of stays, improvements in quality of life? Did the presence of any the alleles associated with success in bariatric surgery affect outcomes? PubMed: High allelic burden of four obesity SNPs associated with poorer wt loss.  Should future efforts be devoted to cases where the disease process is already well-established or where high-risk populations can be identified and appropriate interventions evaluated? In future trials, should comorbid management be left to the local standards of care or defined in the study protocol?

Looking Ahead of Look Ahead

Whither behavioral lifestyle interventions?

The lifestyle interventions in the DPP and Look AHEAD were regarded as the ‘gold standard.’ They involved recruiting and training health professionals who provided not only the intervention but provided a supportive environment and a community spirit. Extensive communication with the patient was maintained. PUBMED: Look AHEAD: Description of the Lifestyle Intervention. Look AHEAD  participants even received an honoraria of $100 at each annual visit to improve adherence. (FDA EMDAC Hearing, March 28, 2012, Dr. Rena Wing, transcript, p. 169).

Recently the CDC and the NIH were looking at ways to take the DPP/Look AHEAD model to a more replicable model. The CDC’s National DPP program awarded $6.75 million in grants to develop lifestyle interventions program among people at high risk. One involves using the YMCA to provide lifestyle counseling. http://www.ymca.net/diabetes-prevention/ Questions will certainly be asked if highly trained professionals with incentives for participants did not produce better results will a down-scale program do better?

Whither diabetes prevention?

Look AHEAD was designed following the Diabetes Prevention Program (DPP). The DPP established that both lifestyle changes and metformin could reduce the incidence of type 2 diabetes, through weight loss, although lifestyle was superior to metformin alone. Look AHEAD was taking this important finding one step further asking whether weight loss among type 2 diabetics would reduce the incidence of cardiovascular events.

Even though the DPP has been promoted as a model for preventing the development of type 2 diabetes through weight loss, there were problems.

Dr. William Knowler of the National Institute on Diabetes, Digestive, and Kidney Disease (NIDDK) told the FDA Advisory Committee earlier this year,that, after three years of the DPP,

“the rates (of development of type 2 diabetes) have tended to flatten out and become parallel among all three groups. The rate of new development of diabetes has actually slowed down in the placebo and metformin groups, compared to what it was in the first three years. And the lifestyle group has flattened out a little bit at the end, but the difference that was attained has been largely maintained over time.  Notice, though, that over 10 years, although there still are remarkable treatment effects, if you look at things in an absolute sense, we can’t say that we still know how to prevent diabetes because, still, close to half of the people who enrolled in the trial developed diabetes over a 10-year period. But at least it’s been substantially delayed in those who have had the interventions.” ( FDA Endocrinologic and Metabolic Drug Advisory Committee Hearing on assessing cardiovascular safety of obesity drugs, March 28, 2012, Transcript, p 131-2).


(Figure: Diabetes Prevention Program Outcomes Study, Lancet (2009) 374; 1677-1686)

Is ‘delaying’ diabetes onset as powerful as ‘preventing’ diabetes from occurring in the competitive race for health care dollars and public attention?

Furthermore, a study earlier this year indicate poor outcomes in drug treatment of adolescents with type 2 diabetes with barely half showing glycemic control with metformin. PubMed: Clinical Trial to Maintain Glycemic Control in Youth with Type 2 Diabetes

Will the Look AHEAD experience affect FDA approval of drugs and devices to treat obesity?

The FDA has viewed obesity as a cosmetic issue and only recently acknowledged it as a disease, worthy of attention as other cardiovascular risk factors. They (meaning the FDA Endocrinologic and Metabolic Drug Advisory Committee and FDA staff) have started, just barely, to view obesity as a cardiovascular disease risk factor, like hypertension. They have also opined, from time to time, that if folks only ate less and exercised more, they would not need drugs. So how does this decision play into these views? On one hand, they may be convinced that obesity is not so easy to treat as they thought by diet and exercise. On the other hand, they may think that there is less need for anti-obesity medications because other treatments, e.g. statins, lipid-lowering drugs, anti-hypertensives, are doing their job in reducing CV risk factors. So, this view may raise the bar for approval of new anti-obesity medications. On the other (the third?) hand, we may need a re-definition of obesity which tones down its “diabetes-metabolic syndrome-mortality” axis and raises its “disability-mobility-quality of life” axis. (Running out of hands here, I would not underestimate the potential for greater evidence of obesity’s role in the development of various cancers).

The recent trend in thinking at the FDA Endocrinologic and Metabolic Drug Advisory Committee (EMDAC) has been to view anti-obesity medications narrowly as cardiovascular disease treatments. The EMDAC met on March 28th and 29th,2012  and discussed how to assess the cardiovascular benefits and safety of anti-obesity medications. At the end of March 28, Dr. Rasmussen, who is the Industry Representative on the committee had the following exchange with Dr. Eric Coleman of the FDA.

Dr. Rasmussen: In your (Dr. Colman’s) presentation, you showed that there are different            populations pre-approval and in post-approval studies. ..Are we compromising the risk-            benefit evaluation if we impose more risk-based patients pre-approval?

Dr. Colman: I’m not sure I understood your question. Could you rephrase it?

Dr. Rasmussen: Maybe I’m preempting some of the discussion that we’ll be having                        tomorrow, whether we should require more high-risk CV patients pre-approval to rule out        a upper bound of the 95 percent confidence interval. But by doing so, we will likely be                including older patients with established cardiovascular risk disease. And I’m wondering          whether including more of those types of patients will compromise the benefits side of                doing the benefit-risk evaluation.

Dr. Coleman: Yes. And it might be that if the program had the resources to do this, that              that would just be one component of the program, and that there would be other be other,        smaller, shorter-term studies where they could study lower-risk individuals, younger                   individuals for shorter periods of time.

Dr. Rasmussen: But my concern was based on the fact that the SCOUT study didn’t really – I      mean, it looks like it wouldn’t be actually be able to be approved if it was submitted pre-            approval. ..(FDA EMDAC, March 28, 2012, transcript at p. 334-5)

On the second day of the hearing, Dr. Rasmussen returned to the topic.

Dr. Rasmussen: So I would just like to add a little bit of perspective on what “enrichment”          (Editor: “enrichment” is the term used here by the FDA referring to adding persons at high        risk of CVD to the pool of subjects in obesity drug trials) in this context will mean. I mean, I      did a little bit of “back-of-the-envelope” calculation, and maybe we’ll have that confirmed        after lunch. But, I mean, current programs, approximately 3,000 patient-years of                        exposure generate 15 MACE events or so. Even if we were to double that patient-year                  exposure with a population of a 3-percent annual event rate coming to additional 60                    events, we would still only be able to exclude a doubling of the hazard ratio. So, I mean,              what we’re talking about here is actually completely shifting the population that we’re                going to study in obesity programs to establish cardiovascular disease and not necessarily        the population that we know actually seek treatment in the real world. So, I think that’s              worth keeping in mind, that enrichment may sound appealing because it sounds like we will       add a fraction of sick patients, but in reality, this will be a complete shift of the population.        (FDA, EMDAC, March 29, 2012, at p. 169)

(Dr. Rasmussen’s calculations appear correction. The cardiovascular safety trial the FDA asked Orexigen Therapeutics to undertake surpassed its original goal of 7,000 patients in process of enrolling 9,000 patients to find 87 major CV events earlier than expected. Orexigen: Press Release Contrave CV study.)

A bit later, Dr. Rena Wing was asked about the influence of statins on the Look AHEAD trial. She responded:

Number one, that more and more people are being treated with statins. There’s better                blood sugar control. There’s better hypertension control. So you’re going to have to look          at what’s going to happen to the event rates in these studies. I was very surprised that your      event rates that you’re showing me in many of these trials looked so high compared to the        event rates we’re seeing in Look AHEAD. Now, some of that is because we did do GXTs.                (Editor: Graded Exercise Tests.) We did select healthier patients. But I also think that if you      are doing trials, in the United States especially, and with diabetics where there’s more and        more emphasis on increasing the use of lipids, increasing their blood pressure control, that      you’re going to be driving down your risk factors, and you’re going to have more and more      confounds with medication. (FDA, EMDAC, March 29, 2012 transcript, at p. 346)

At the Cleveland Clinic’s Obesity Summit earlier this month, I asked cardiologist Steve Nissen about the FDA’s pushing companies to undertake clinical trials to rule out a CVD risk. He responded that one of the challenges of cardiovascular outcome studies of obesity drugs is that in order to get enough cv events you have to study patients with existing heart disease or at very high risk of a cv event . This pushes the trial into populations which are considerably sicker than the population likely to take the obesity drug. He suggested that FDA should look at absolute risk rather than the relative risk of the drug. If one looks at the absolute risk, you can study any reasonable population likely to take the drug. This change in the statistical approach allows one to study more typical populations.

 

In any event, it will be sometime before we know how the newer anti-obesity medications, like Contrave if approved), Belviq™ and Qysemia™ will impact cardiovascular disease risk factors.

Bariatric Surgery: Last Man Standing?

A study out of the Cleveland Clinic published in the New England Journal of Medicine in April, 2012 followed over 90% of 150 patients for 12 months. The study, a face to face comparison of medical therapy versus surgery in patients with uncontrolled type 2 diabetes, showed a clear superiority for bariatric surgery.  The proportion of patients achieving a hemoglobin A1c level of 6% after 12 months by medical therapy alone was 12%; for those in the medical plus gastric bypass surgical group it was 42% and for the medical plus sleeve-gastrectomy group it was 37%. Weight loss was greater in the gastric bypass group (-24kg) and sleeve gastretcomy group (-25.1kg) than in the medical therapy group (-5.4kg). Use of drugs for glucose control, lipids and blood pressure control decreased in the surgical group but increased in the medical group. PubMed: Bariatric surgery versus intensive medical therapy in obese patients with diabetes

In regard to cardiovascular risk factors, a systematic review of the literature on bariatric surgery analyzed over 60 studies involving 19,543 patients. At baseline, the mean patient was 41.7 years old, female and had a BMI of 47.1. Baseline prevalence of comorbid conditions which increase risk of CVD was hypertension (44.4%), diabetes (24%) and hyperlipidemia (43.6%). After correcting for publication bias, 36% of subjects had improvements in hypertension, 26% for diabetes and 34% for hyperlipidemia. Calculating the changes for mean participants, the authors found that a woman, without baseline CVD, diabetes or smoking, who is taking anti-hypertensive drugs, will move from an 8.6% 10 year global risk for CVD to a 3.9% risk. A man, with no CVD or smoking but whose diabetes and need for anti-hypertensive drugs resolves after surgery, will move from a 10 year global risk of 18.4% to 4.7%. PubMed: Bariatric Surgery and Cardiovascular outcomes: a systematic review

So, where are we? The gold standard of lifestyle change is tarnished. The drug story is muddy at best. Bariatric surgery is clearly producing the superior results. However, access to surgery is, and will remain, a problem. The challenge for the leaders in the field is to find ways to have surgery reach more people and not be a procedure for the 1 percent. Even with greater access to surgery, the obesity-diabetes epidemic will continue to be a major health crisis. It’s time to be humble in the face of this disease and realize a lot more research is going to be needed…and soon.

 

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Posted in Behavior, Counseling, DAILY DOWNEY, Featured, Federal Government, Treating Obesity

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Texas Grapples with Costs of Bariatric Surgery

June 24th, 2012

The New York Times reports on the issue of Texas, which has one of the highest rates of obesity in the country, grappling with the costs of bariatric surgery in Medicare and Medicaid. NYT:Spending for Weigh Loss Surgery Increases in Texas

No doubt this scenario will be played out in many states in the coming years. I’ve always said, “Obesity is too expensive to treat and it is too expensive not to treat.” This article bears this out. The tipping point for me is that at least with treating, we are reducing suffering for some humans. Predictably, at the end of the article a professor is cited as saying that the state could reach many more people with less expensive lifestyle interventions and improve their health enough to save far more dollars than bariatric surgeries do. This would be true if any lifestyle intervention was shown to achieve bariatric surgery’s long term, significant weight loss, with a reduction in co-morbidities, such as type 2 diabetes. But the professor’s statement is still, after millions of dollars of research on lifestyle changes, only a hypothesis, yet to be established.

 

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Posted in Bariatric Surgery, DAILY DOWNEY, ECONOMICS, Featured, Health Care Costs, States and Localities

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Improvements Seen in Obesity Reimbursement

May 13th, 2012

A Washington Post article by Judith Graham points out the progress made in getting insurers and physicians to screen patients for obesity and reimburse for counseling and treatment. I can add that at one of the recent FDA Advisory Committee meetings, an FDA health officer presented data indicating that about half of prescription drugs for obesity were paid for by insurance plans now. WaPo: BMI as vital sign

In addition, conversations with health plan representatives indicate that they are getting more requests from employers for riders covering obesity interventions, including bariatric surgery. These are considerable improvements from a few years ago.

 

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Posted in Bariatric Surgery, DAILY DOWNEY, Drug Therapy, Featured, MANAGING OBESITY, Treating Obesity

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Michelle Obama Changing Military Food Choices

February 9th, 2012

Reuters has reported that Michelle Obama will join in an announcement of new nutrition standards for the armed forces 1,100 dining facilities. Over a quarter of eligible 17-24 year olds are too overweight to join the military. Once in, members of the military are gaining too much weight. Department of Defense officials describe this as a “national security problem.” The military spends about $4.65 billion on food services each year and an estimated $1.1 billion on medical care associated with excess weight and obesity. http://www.reuters.com/article/idUSL2E8D90AO20120209

The military’s struggle with obesity has always been an interesting one. It is probably the largest sub-group in the US population with a high number of young people and a culture most supportive of physical activity. In addition, exceeding the different services’ weight standards can result in loss of a career. So, with all that, one would think it would have it’s weight problem pretty well under control. Yet, it isn’t which is probably due to the fact that it is not as isolated from the rest of society. In addition, the physical work of soldiers and sailors have given way to more and more technologically based skills.  Nonetheless, fighting wars, repeated deployments and family issues drives up stress. Obesity rates of US soldiers has doubled since the start of the Iraq war. Families are also affected. Tens of thousands of spouses have had bariatric surgery costing $363 million over ten years. Military spent $363million on WEIGHT-LOSS surgery for obese soldiers’ wives over last ten years | Mail Online One spouse reported becoming depressed and engaging in emotional eating and finally losing 118 pounds.

The future problems for military recruitment are very serious. John Cawley and JC Maclean have calculated that from 1959-2008 the percentage of the population ineligible for service more than doubled for men and tripled for women. They estimate that a 1% rise in weight and body fat would further reduce eligibility by over 850,000 men and 1.3 million women. Unfit for service: the implications of rising ob… [Health Econ. 2011] – PubMed – NCBI

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Primum Non Nocere*

November 28th, 2011

Many media outlets are reporting on the removal of a 200 lb. 8 year old from his family in Cleveland. Cleveland is, of course, the home of Toby Cosgrove, MD, head of the Cleveland Clinic, who proclaimed his desire to not hire workers who were obese. This came a year or so after the American Medical Association took the official position that persons who are obese are not entitled to compensation for being disabled for being unable to work. 

The intellectual justification for the forced removal of the child from his family is that provided by Dr. David Ludwig of Harvard Medical School.  State Intervention in Life-Threatening Childhood Obesity, July 13, 2011, Murtagh and Ludwig 306 (2): 206 — JAMA In the Commentary in July in the Dr. Ludwig had indicated that the forced removal by the state of children who were obese was justified. 

On what basis, you might ask? Well, there were several and they were all, in my opinion, intellectually bankrupt.

First, Dr. Ludwig and his co-author Lindsey Murtagh, J.D., assume “even mild parenting deficiencies such as having excessive junk food in the home or failing to model a physically active lifestyle, may contribute to a child’s weight problem.”

Excuse me? Before you go calling these “parental deficiencies,” how about defining: “excessive”, “junk food” or “failing to model a physically active lifestyle? Well, forget about it. They don’t define their terms.

What do they mean by “may contribute” to a child’s weight problem? If you are arguing that these “mild parental deficiencies” cause life-threatening conditions, is “may” good enough? What is the degree of evidence? If you are arguing that these conditions merit breaking up a family should not the evidence be like, beyond a reasonable doubt or a preponderance of the evidence? Is “may” good enough?

Second, they posit that severe obesity (a BMI at or beyond the 99th percentile) represents a fundamentally different situation than most overweight and obese children who have “the opportunity to ameliorate these risks through behavior change and weight loss as adults.” So, they say that severe obesity is fundamentally different “suggesting profoundly dysfunctional eating and activity habits”. Obesity of this magnitude can cause immediate and potentially irreversible consequences, most notably type 2 diabetes”.

Excuse me? Where is it written that persons with severe obesity as a child have a much smaller likelihood of reversing it as an adult than those with a lower level of obesity?

And what makes the BMI, which we know is a limited measure of body adiposity, at the 99th percentile different from the 97th percentile or the 95th percentile or the 92nd  percentile for that matter?

They argue that  severe obesity ‘suggests’ profoundly dysfuncitional eating and physical activity habits? ‘Suggests?’ They aren’t sure? If they are proposing breaking up a family maybe something more than ‘suggests’ is warranted. More importantly, could it not be that we are confusing cause and effect.  If there is anything to the increases in height and weight over the past 350 years, if there is anything to the contribution of genetic inheritance to obesity, if there is anything to the contribution of epigenetic factors to obesity, then, we must at least allow the suggestion that some children are born programmed to be overweight or obese. Upon achieving that status, one would assume they would overeat and underexercise compared to their normal weight peers. Would these be acquired ‘habits’ or the adaptions to their body habitus?

When they say that obesity of this magnitude can cause immediate and potentially irreversible consequences, most notably type 2 diabetes, what do they mean? Only a subset will develop type 2 diabetes immediately and for many, it will be manageable by lifestyle, drugs or surgery. Others, at a BMI lower than the 99th percentile and some who are merely overweight or normal weight will develop diabetes as well.

Third, (here’s the rub) the authors point with alarm that these patients may have to have bariatric surgery, whose long-term safety and effectiveness is not established. Therefore, they propose an alternative “therapeutic approach” i.e., placement of the severely obese child under state protective custody. The authors state, “Indeed, it may be unethical to subject such children to an invasive and irreversible procedure without first considering foster care.”

Doh? Did I get this right? Because at some point in the future, a child has continued to suffer with obesity and decides to have bariatric surgery, Ludwig and Murtagh propose the state comes in when the child is a juvenile and break up the only family the child has ever known?

Friends, I have worked for years with the professional jealousy of surgeons and internists and non-physician health care professionals. For the most part, they keep these often bitter inter-professional competitions to themselves. But this approach of Ludwig and Murtagh is nothing more than saying that breaking up a family, taking an obese child away from their mother and father and siblings, making them a ward of the state, having them raised by strangers who are paid for their care is better than even the potential that someday that person may want/be eligible for/can pay for bariatric surgery. 

The bias is demonstrated by the additional point raised by the authors that, “Although removal of the child from the home can cause families great emotional pain, this option lacks the physical risks of bariatric surgery. Moreover, family reunification can occur when conditions warrant, whereas the most common bariatric procedure (Roux-en-Y anastomosis [gastric bypass]) is generally irreversible.” Well, this is factually wrong. Roux-en-Y is not the most common bariatric procedure. The reversible laproscopic gastric banding is. Metabolic/bariatric surgery Worldwide 2008. [Obes Surg. 2009] – PubMed – NCBI  And  emotional pain may play a  particularly important role on the development of obesity. See this recent post.

And what does family reunion “when conditions warrant” mean? There are several options here which are starkly different and completely unaddressed by the authors. One option is that the obese child has returned to normal weight. The second option is that the obese child is still obese or has lost some weight but has improved eating or physical activity behaviors. The third option is that one parent or both have improved their ‘deficiencies’ by (a) removing only ‘excessive’ junk food in the home and/or (b) modeling a physically active lifestyle, independent of any change in the child. (Did I mention that the NIH guidelines for pediatricians on weight management did not find much support for physical activity?)

The fourth option is that that the foster care parents are both removing excessive junk food and modeling a physically active lifestyle and the child is continuing to gain weight. In some cases, there may be no “family reunification” but a succession of foster homes, all equally unable to affect the child’s excess adiposity. 

At the very end of their Commentary, Ludwig and Murtagh do a bit of a CYA, stating, “Nevertheless, state intervention would clearly not be desirable or practical, and probably not be legally justifiable, for most of the approximately 2 million children in the United States with a BMI at or beyond the 99th percentile. Moreover, the quality of foster care varies greatly; removal from the home does not guarantee improved physical health, and substantial psychosocial morbidity may ensure. Thus, the decision to pursue this option must be guided by carefully defined criteria such as those proposed by Varness et al with less intrusive methods used whenever possible.”

Now, dear reader, when one comes upon a statement like this, one assumes that Varness, et al, is in at least broad agreement with Ludwig and Murtagh. So it came as some surprise to actually read the cited Varness articles. See Childhood obesity and medical neglect. [Pediatrics. 2009] – PubMed – NCBI 

What Varness says is that, for a child to be removed from their home, all 3 of the following criteria have to be met: (1) a high likelihood that serious imminent harm will occur; (2) a reasonable likelihood that coercive state intervention will result in effective treatment and (3) the absence of alternative options for addressing the problem.

Regarding #1, a high likelihood that serious imminent harm will occur, Varness states, “The mere presence of childhood obesity does not predict serious imminent harm…Although childhood obesity is a risk factor for the development of multiple diseases as an adult, increased risk for adult diseases does not constitute serious imminent harm.” At the other end of the spectrum are current risks, such as severe obstructive sleep apena with cardiorespiratory compromise, uncontrolled type 2 diabetes and advanced fatty liver disease with chirrhosis. In some cases, like advanced hepatic fibrosis, the harm cannot be reversed in adulthood. Varness et al state, contrary to Ludwig and Murtagh, “There is no clear threshold level of childhood obesity (overweight, obese, or severely obese) that automatically predicts serious imminent harm….Although it is true that childhood obesity can lead to adult obesity, childhood obesity itself does not seem to lead to irreversible changes that are significant enough to mandate coercive state intervention.”

Regarding #2, a reasonable likelihood that coercive state intervention will result in effective treatment, Varness states, “In other words, is it truly reasonable to demand that families be able to achieve effective weight loss for their children? In addition, if it has been impossible for a family to reduce weight, what evidence is there to suggest that removal from the home would be more successful?” 

Regarding #3, the absence of alternative options for addressing the problem, Varness clearly does not share Ludwig and Murtagh’s antipathy for bariatric surgery. He states, “In summary, medications and surgery hold some promise but still have a questionable risk/benefit ratio, in both the short term and the long term. Although these may seem to be attractive options for some motivated adolescents with severe obesity, they are not options that are likely to be mandated for a child over the family’s objections. In contrast to the Ludwig-Murtagh paradigm of “mild parenting deficiencies,” Varness observes, “ In most cases of obesity, families make a good-faith effort to address the problem when they are made aware of the condition and the potential adverse health consequences. The development of a serious comorbidity can serve as a “wake-up call” for families, prompting full cooperation with intensified medical services.”

In sum, Varness makes the case that state intervention for obese children with no comorbidity is not justified; for those with a serious imminent harm, e.g. obstructive sleep apnea with cardiorespiratory compromise, intervention is probably justified. In between, only those risks known to be irreversible as an adult, such as hepatic fibrosis resulting from nonalcoholic fatty liver disease as opposed to cardiovascular disease, seems to be justified.

Finally, contrary to the misinformation about bariatric surgery, Varness notes that, “If a medical or surgical intervention that has a very high probability of decreasing weight with minimal adverse events is developed, then the availability of this effective treatment might result in a stronger intervention on behalf of children. For instance, gastric banding is a reversible procedure that involves the laparoscopic placement of an adjustable band around the proximal stomach. This procedure is not approved by the Food and Drug Administration for adolescents, and long-term data on its efficacy and complications are lacking. However, this procedure may hold some promise for extremely obese children, particularly as it is reversible.” In other words, coercive state action may be justified for bariatric surgery, rather than as an alternative to bariatric surgery, as desired by Ludwig and Murtagh. Not to belabor the point, but it seems Varness contradicts every major point Ludwig and Murtagh make. Curious, no?

My problem with the Ludwig-Murtagh commentary is not just on its intellectually bankruptcy and the harm it is bringing on persons who have enough pain it their lives. It is the question of what is Organized Medicine doing? So the position of Organized Medicine is this: Persons with obesity should be denied jobs (and, presumably, employer-provided health care), denied disability compensation when they cannot work, empathetic treatment by their physician and now the support of their own families in favor of unknown, paid-to-be-parents in foster care? Shouldn’t medicine be looking for better treatments? Maybe diagnosing their own patients? Maybe making appropriate referrals? Why don’t Dr. Ludwig and Attorney Murtagh call on pediatricians to develop better treatment protocols for children and adolescents with obesity? Why don’t they call on the American Academy of Pediatrics to lobby for dedicated funding for research on new treatments? Why don’ they criticize their fellow pediatricians who neglect to advise their patients on weight loss, in my opinion, unethically so. Pediatricians, in particular, have spent decades telling parents their children will ‘grow out of’ their weight problems. Now that obesity has become epidemic, they have done next to nothing to actually treat the disease, instead pointing to food companies’ marketing, television viewing, computers, vending machines, and parents as the culprits. Is it too much to ask them to develop treatments for their patients and quit blaming everyone else?

This blaming is only driving parents away from consulting with primary care providers, as discussed in Dr. Arya Sharma’s blog today. www.drsharma.ca.



If medicine, and especially, pediatrics, cannot help, at least stop making matters worse. 

See County places obese Cleveland Heights child in foster care | cleveland.com

Associated Press, MSNBC News: U.S. News – Ohio puts 200-pound third-grader in foster care

ABC News: Health » Obese Third Grader Taken From Mom, Placed in Foster Care Comments Feed

Background: Should parents lose custody of super obese kids? – Washington Times 

* Latin for “First, Do No Harm”

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Posted in Childhood Obesity, DAILY DOWNEY, Featured, HEALTH & STIGMA, NEWS, Weight Bias

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Unspoken: The Childhood Sexual Abuse – Obesity Connection

November 14th, 2011

For the past week, shocking news has come out of Penn State University of alleged child sexual abuse by a former football defensive coach, Jerry Sandusky. The scandal has taken down the university’s president and its famed head coach, Joe Paterno. The school’s credit rating has been downgraded;  federal and state agencies are investigating.

Most of us react to such news with a sickening feeling of the psychological trauma the victims of such abuse, in this case including a 10 year old boy, must endure. Less well researched is the connection between child sexual abuse and adult diseases including mortality.

In 1998, Felitti et al. published a paper on the relationship of childhood abuse and household dysfunction to the leading causes of death in adults. Their study included children who were exposed to psychological, physical or sexual abuse, violence against the mother, living with household members who were substance abusers, mentally ill or suicidal or ever imprisoned. They founded a graded relationship between the number of categories of childhood exposure and adult health risk behaviors. Persons who had experienced four or more categories of exposure, compared to none, had a 4-fold to 12-fold increase in health risks for alcoholism, drug abuse, depression and suicide attempt; a 2-4 fold increase in smoking, poor self-reported health, over 50 sexual partners and sexually transmitted disease; and a 1.4 to 1.6 fold increase in physical inactivity and severe (over BMI of 35) obesity. They found, “The seven categories of adverse childhood experiences were strongly interrelated and persons with multiple categories of childhood exposure were likely to have multiple health risk factors later in life.” Relationship of childhood abuse and household … [Am J Prev Med. 1998] – PubMed – NCBI

The author, Dr. Vicent J. Felitti, was with the Southern California (Kaiser) Permante Medical Group. In 2010, he and colleagues authored another paper on medical group’s Positive Choice Weight Loss Program. The program was achieving remarkable success with a combination of absolute fasting and a group program to explore the basis of each participant’s unconscious use of food and to explore the hidden benefits of obesity for the individual. Yes, the benefits of obesity.

The group found that their ability to quickly bring about significant weight loss was frustrated by the high dropout rate of persons who were successful or who sabotaged their own efforts. They took detailed life histories of 286 patients. Writes Dr. Felitti, “Here, we unexpectedly discovered that histories of childhood sexual abuse were common, as were histories of growing up in markedly dysfunctional households. It became evident that traumatic life experiences during childhood and adolescence were far more common in an obese population that was comfortably recognized. We slowly discovered that major weight loss is often sexually or physically threatening and that obesity, whatever its health risks, is protective emotionally…The antecedent life experiences of the obese are quite different from those of the always-slender. “ A bit later, he notes, “By the mid-1980s, we had learned that our initial goal of teaching people to “eat right” was totally irrelevant to obesity, although it seemed a reasonable thing to do when we did not know what to do.” The group found that for many participants, obesity is beneficially protective: sexually, physically and socially. A woman who had rapid weight gain was raped at age 23 and subsequently gained 105 lbs. She said, “Overweight is overlooked, and that’s the way I need to be.” Finally, the program found two major predictors of weight regain: a history of childhood sexual abuse and currently being married to an alcoholic (generalizable to having a significantly dysfunctional marriage).  Obesity: Problem, Solution, or Both? 

A recent review of the published literature on interpersonal violence and obesity seems to bear out Dr. Felitti’s research. Reviewing 36 separate studies, A.J. Midei and K.A. Matthews found 81% of the studies reported a significant positive association between some type of childhood interpersonal violence and obesity, although 83% of the studies were cross-sectional. Associations were consistent for caregiver physical and sexual abuse and peer bullying. Mechanisms were not clearly identified although anger, stress, depression, sadness and loneliness were cited. Interpersonal violence in childhood as a risk facto… [Obes Rev. 2011] – PubMed – NCBI 

Perhaps, then, it should not be a surprise to find a high prevalence of patients with histories of childhood sexual abuse seeking bariatric surgery. Sexual abuse survivors and psychiatric hospitaliza… [Obes Surg. 2007] – PubMed – NCBI and childhood sexual abuse +bariatric surgery – PubMed – NCBI and Childhood maltreatment in extremely obese male and … [Obes Res. 2005] – PubMed – NCBI.

The point is that we, as a society, are just beginning to understand the devastation childhood sexual abuse can cause on the human psychological and physiological systems. We also need to realize that the person with obesity, so often scorned, isolated and penalized, may well be the adult survivor of unspeakable childhood trauma.

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