Archive for June, 2013

Results of Look Ahead Published

June 26th, 2013

As indicated on October 22, 2012, the Look Ahead trial was stopped early on the basis of futility. Now, we have the results of the study in the New England Journal of Medicine, June 25, 2013. The trial was a long-term study of intensive lifestyle intervention for weight loss to see if that would decrease cardiovascular morbidity and mortality among patients with type 2 diabetics. After 9.6 years, the study was stopped. While weight loss was greater in the intervention group than in the control group (6.0% v. 3.5% at study end), the intensive weight loss did not reduce the rate of cardiovascular events. The lifestyle intervention did reduce HbA1c, improve fitness and all cardiovascular risk factors except for low-density lipoprotein cholesterol levels. In addition, earlier reports indicated that the lifestyle group was more likely to have a partial remission of diabetes during the first 4 years of the trail than those in the control group and also showed reductions in urinary incontinence, sleep apnea, and depression and improvements in quality of life, physical functioning and mobility.

 

Wellness Programs’ Dubious Claims

June 24th, 2013

In a Wall St. Journal Op-Ed June 21, 2013, Here Comes ObamaCare’s ‘Workplace Wellness, authors Al Lewis and Vik Khanna take on claims of savings achieved by wellness companies. They write, “Almost every wellness company shows savings by comparing motivated participants in its programs with un-motivated, non-participants-ignoring, for example, the obvious fact that people who want to quit smoking will quit at higher rates than those who don’t regardless of whether an employer offers a program. Another trick is to count only the people who improve – such as smokers who quit, but not quitters who resume smoking…Enough employees resent the intrusiveness of these programs that the National Business Group on Health reports that since 2009 the average employer has had to double incentives-such as cash payments and reductions in insurance premiums – to maintain employee participation. The well-publicized $600 penalty that the drugstore chain CVS levied in 2013 on employees who refused to participate in screenings to measure body-mass index, weight and glucose levels is more typical than not. The average amount that employees forfeit by refusing to participate in wellness programs is $521, according to the National Business Group on Health.”

 

Huffington Post Live Discussion of AMA Decision

June 20th, 2013


Here is the link to the HuffPost Live Discussion:

http://live.huffingtonpost.com/r/segment/ama-recognizes-obesity-as-a-disease/51c1cd312b8c2a0a3100028d

Enjoy.

HuffPost Live on AMA Decision

June 20th, 2013

Join us Thursday at 11:05 for a discussion of the AMA decision on HuffPost Live. See http://live.huffingtonpost.com/r/segment/ama-recognizes-obesity-as-a-disease/51c1cd312b8c2a0a3100028d

AMA Recognizes Obesity as a Disease

June 18th, 2013

The AMA House of Delegates did not adopt a report (scroll down to page 19) from it Board of Trustees and instead voted to recognize obesity as a disease, according to a report from Forbes. For background click here.

Here is the New York Times report:

A.M.A. Recognizes Obesity as a Disease

By 

The American Medical Association has officially recognized obesity as a disease, a move that could induce physicians to pay more attention to the condition and spur more insurers to pay for treatments.

In making the decision, delegates at the association’s annual meeting in Chicago overrode a recommendation against doing so by a committee that had studied the matter.

“Recognizing obesity as a disease will help change the way the medical community tackles this complex issue that affects approximately one in three Americans,” Dr. Patrice Harris, a member of the association’s board, said in a statement. She suggested the new definition would help in the fight against Type 2 diabetes and heart disease, which are linked to obesity.

To some extent, the question of whether obesity is a disease or not is a semantic one, since there is not even a universally agreed upon definition of what constitutes a disease. And the A.M.A.’s decision has no legal authority.

Still, some doctors and obesity advocates said that having the nation’s largest physician group make the declaration would focus more attention on obesity. And it could help improve reimbursement for obesity drugs, surgery and counseling.

“I think you will probably see from this physicians taking obesity more seriously, counseling their patients about it,” said Morgan Downey, an advocate for obese people and publisher of the online Downey Obesity Report. “Companies marketing the products will be able to take this to physicians and point to it and say, ‘Look, the mother ship has now recognized obesity as a disease.’ ”

Two new obesity drugs — Qsymia from Vivus, and Belviq from Arena Pharmaceuticals and Eisai — have entered the market in the last year.

Qsymia has not sold well for a variety of reasons, including poor reimbursement and distribution restrictions imposed because of concerns that the drug can cause birth defects. Those restrictions are now being relaxed. Belviq went on sale only about a week ago, so it is too early to tell how it is doing.

Whether obesity should be called a disease has long been debated. The Obesity Society officially issued its support for classifying obesity as a disease in 2008, with Mr. Downey as one of the authors of the paper.

The Internal Revenue Service has said that obesity treatments can qualify for tax deductions. In 2004, Medicare removed language from its coverage manual saying obesity was not a disease.

Still, Medicare Part D, the prescription drug benefit, includes weight loss drugs among those it will not pay for, along with drugs for hair growth and erectile dysfunction.

The vote of the A.M.A. House of Delegates went against the conclusions of the association’s Council on Science and Public Health, which had studied the issue over the last year. The council said that obesity should not be considered a disease mainly because the measure usually used to define obesity, the body mass index, is simplistic and flawed.

Some people with a B.M.I. above the level that usually defines obesity are perfectly healthy while others below it can have dangerous levels of body fat and metabolic problems associated with obesity.

“Given the existing limitations of B.M.I. to diagnose obesity in clinical practice, it is unclear that recognizing obesity as a disease, as opposed to a ‘condition’ or ‘disorder,’ will result in improved health outcomes,” the council wrote.

The council summarized the arguments for and against calling obesity a disease.

One reason in favor, it said, was that it would reduce the stigma of obesity that stems from the widespread perception that it is simply the result of eating too much or exercising too little. Some doctors say that people do not have full control over their weight.

Supporters of the disease classification also say it fits some medical criteria of a disease, such as impairing body function.

Those arguing against it say that there are no specific symptoms associated with it, that it is more a risk factor for other conditions than a disease in its own right.

They also say that “medicalizing” obesity by declaring it a disease would define one-third of Americans as being ill and could lead to more reliance on costly drugs and surgery rather than lifestyle changes. Some people might be overtreated because their B.M.I. was above a line designating them as having a disease, even though they were healthy.

The delegates, rejected the conclusion of the council and voted instead in favor of a resolution pushed by the American Association of Clinical Endocrinologists, the American College of Cardiology and some other organizations.

This resolution argued that obesity was a “multimetabolic and hormonal disease state” that leads to unfavorable outcomes like Type 2 diabetes and cardiovascular disease.

“The suggestion that obesity is not a disease but rather a consequence of a chosen lifestyle exemplified by overeating and/or inactivity is equivalent to suggesting that lung cancer is not a disease because it was brought about by individual choice to smoke cigarettes,” the resolution said.

 

 

 

Image: www.cbsnews.com

 

AHRQ: Policy-based non-evidence evidence?

June 17th, 2013

 

Summary: Preventing weight gain among adults is a national health care priority. So I read with interest a recent AHRQ effectiveness review which found scant evidence of any strategy to prevent weight gain working. AHRQ went on to conclude that, “there was no evidence that not adopting a strategy to prevent weight gain is preferable.” In addition, contrary to the implication, AHRQ reviewers did not look for evidence when or if weight gain might be desirable. They seemed to put in that conclusion to buttress the Healthy People 2020 policy goals. AHRQ’s reviews are meant to inform policy; not for policy to spin research reviews. Here’s the story.

Now I concede to no one my respect for the Agency for Healthcare Quality and Research (AHRQ).  I have always felt they were a very reliable source for objective evaluations of research data, often used to drive policy. In fact their mission includes the goal to “Improve health care outcomes by encouraging the use of evidence to make informed health care decisions.”

I believe we have their literature reviews and assessments some twenty times or more on this site. When policy-makers say a recommendation is “evidence-based” they usually mean an AHRQ review of the literature supports it. And AHRQ likes it that way.

Recently AHRQ published Strategies to Prevent Weight Gain Among Adults, one of a series of Comparative Effectiveness Reviews, developed by the Johns Hopkins Evidence Based Practice Center,

This review examined 58 publications from 51 studies on maintenance of weight or prevention of weight gain among adults involving over a half-million patients. Studies targeting a combination of weight loss with weight maintenance or weight loss exclusively were considered outside the scope of the review. Studies had to have at least one year of follow-up with a weight outcome.

The results,given the billions of dollars invested by governments at all levels and by private companies and individuals, are pretty grim. Only two interventions were found to have moderate strength evidence of effectiveness. The first was a workplace intervention involving both individual diet and physical activity with environmental intervention that resulted in significant and meaningful prevention of BMI increases at one year and weight gain at 24 months compared with no intervention. The second intervention involved aerobic and resistance exercise performed at home by women with cancer compared to no intervention.

Additional analysis revealed, “Potentially effective interventions with low strength of evidence include a clinic-based program to teach heart rate monitoring, a combination intervention for mothers of young children, small group sessions to educate college women, and physical activity among individuals at risk of cardiovascular disease and diabetes. Potentially effective approaches described in observational studies having low strength of evidence include eating meals prepared at home among college graduates and less television viewing among individuals with colorectal cancer. When reported, adherence to interventions tended to be below 80% percent. There were no adverse events among the few trials that reported on adverse events. Trial study quality tended to be poor due to knowledge of the intervention by the study personnel who measured the weight of the participants or lack of reporting on this item. This lack of blinding the outcome assessor along with inclusion of studies that were not designed to prevent weight gain resulted in a low strength of evidence for the majority of comparisons.”

The authors conclude, “The literature provides some, although limited, evidence about interventions and approaches that may prevent weight gain. Although there is not strong evidence to promote a particular weight gain prevention strategy, there is no evidence that not adopting a strategy to prevent weight gain is preferable.”(Emphasis in original.)

I must admit to a certain whiplash reading that last sentence. ‘No evidence on not adopting a strategy?’  On the critical national issue of prevention of weight gain, limited evidence that anything works but “no evidence” that not doing something is better? Eh?

  1. So, my first question was, “Did they look for evidence of ‘not adopting a strategy”?

Well, yes and no. Yes: they had excluded from their review studies involving three classes of patients in whom strategies preventing weight gain are commonly not recommended: (a) pregnant women, (b) patients with wasting diseases, such as cancer, HIV/AIDs, eating disorders, and, (c)  lean persons with a BMI of 18.5 kg/m2 or less. See inclusion and exclusion criteria. So, they knew strategies to prevent weight gain were not ‘preferable’ for these rather sizeable groups. (FYI, weight loss for cancer patients is a current research issue in the cancer field, see Downey Obesity Report, May 5, 2012.

But also the answer was No. They did not look for other categories for whom prevention of weight gain might not be indicated. The description of the review states, “We aimed to compare the effectiveness, safety, and impact on the quality of life of strategies to prevent weight gain among adults. Self-management dietary, physical activity, orlistat and combinations of these strategies were considered.” The reviewers developed six Key Questions. By starting with the strategies, as opposed to asking, “For whom is prevention of weight gain contra-indicated?” they missed some key groups.

A quick search of PubMed revealed several, rather sizeable groups, such as:

Older women, one study found higher fat mass was associated with better survival.

The frail elderly, for whom weight loss may be associated with adverse outcomes. (In one study, weight loss among elderly Mexican Americans was shown to predict death. Of those who had lost 5% of weight, 28% died, compared to 19.7% whose weight had remained stable and 15.2% of those who gained weight after 5 years.) See also, The danger of weight loss in the elderly.

Patients with COPD, for whom weight loss is a significant driver of costs and mortality. Overweight and obesity is protective of mortality in patients with COPD.

Patients with Cystic Fibrosis for whom higher BMI is associated with improved lung function.

Patients with Parkinson’s Disease for whom weight loss reduces quality of life.

Nursing Home Patients for whom weight loss can be an indicator of dysphagia, depression and malnutrition.

Patients with psychiatric disorders for whom weight loss is often contraindicated because of low adherence to program protocols and because many anti-psychotic drugs cause weight gain. (However, there are studies and views to the contrary,  see http://well.blogs.nytimes.com/2013/04/15/a-battle-plan-to-lose-weight/)

Patients with ALS who have a high risk of malnutrition as well as patients with multiple sclerosis.

Patients hospitalized with pneumonia for whom obesity is associated with better short term survival.

The point is not when weight gain should be avoided or when overweight or obesity is protective. The point is that contrary to AHRQ’s conclusion that “there is no evidence that not adopting a strategy to prevent weight gain in preferable” (Emphasis in original), there is ample preliminary evidence, at least, that, in significant populations, not adopting a strategy to prevent weight gain is not only preferable, it may be protective.

  1. Is there a problem with recommending pursuit of weight prevention strategies which are likely to be futile?

Well, there are several problems on both an individual and societal level.

With repeated weight loss attempts, weight gain is likely to follow. Dr. N. John Bosonworth argued in 2012 article that, “sustained weight loss is achieved by a small percentage of those intending to lose weight. Mortality is lowest in the high-normal and overweight range. The safest body-size trajectory is stable weight with optimization of physical and metabolic fitness. With weight loss, there is evidence for lower mortality in those with obesity-related comorbidities. There is also evidence for improved health-related quality of life in obese individuals who lose weight. Weight loss in the healthy obese, however, is associated with increased mortality.” He advises weight loss only for those with obesity-related comorbidities.

Ross and Janiszewski, among others, argue that exercise, independent of weight loss, is preferable as a strategy to reduce cardiovascular disease risk. Indeed, one recent study out of Europe of over 250,000 men and women found that high levels of physical activity reduced waist circumference in both men and women, reducing the odds of becoming obese by 7% and 10% respectively.

Perhaps more importantly (to me at least), the statement that “Although there is not strong evidence to promote a particular weight gain prevention strategy, there is no evidence that not adopting a strategy is preferable,” is a tortured linguistic effort to continue to blame individuals for their personal failure to avoid weight gain, even though the recommendations of the experts have failed. This is simply a perpetuation of stigma without evidence from the federal agency whose raison d’etre is evidence-based conclusions. That such personal blame and stigmatization is harmful and counterproductive is now beyond conjecture.

(As a point of personal privilege, I have to note that I have observed over the years that, when strategies proposed by ‘experts’ in the field run aground (rather predictably I might add) the blame falls on the persons who are overweight or obese whose lack of adherence or whose hedonistic tendencies are seen as undercutting the recommendations of the professional. I cannot recall one instance where reviewer(s) concluded that the recommendations might be wrong or at least should be re-evaluated.)

For many years a chorus of critics have seen a sinister conspiracy between the government and weight loss industry. According to their view, the conspiracy promotes an unrealistic and unattainable body image goal on the public, especially on women and young women, leading to obsessive attention to fatness in the society. In turn, this can lead to dangerous or ineffective weight loss efforts, body image dissatisfaction and loss of self-esteem. (This concern receives passing acknowledgement in a single paragraph on p.120 of the review.)

Unfortunately, the conspiracy theorists might find support in this review. Who benefits, they could well ask,  from pursuit of ineffective weight prevention strategies? Not the person trying to prevent weight gain. The review already established that no particular strategy is particularly effective. So, pursuing some strategy only can mean the transfer of time but mainly money to programs, services or products to assist in the weight gain prevention effort and the diversion of such time/money away from other activities, which might be more useful to the individual or society, such as expanding one’s education, time caring for children or one’s parents, volunteering at schools, nursing homes, etc.  As we have seen with the debate over employer wellness programs, more and more employers are imposing sizeable financial penalties on workers who fail to achieve a weight maintenance target or weight loss goal which could be up to 30% of one’s individual or family health insurance premium. (See Downey Obesity Report.) So the costs of the loss or prevention activity can be substantial and the cost of failure can be substantial as well.

Finally, there is the issue of the credibility of the country’s public health authorities and confidence in their recommendations, that when they say there is “no evidence” it is fair for readers to assume they looked for evidence and found none.

I emailed one of the authors. I wrote, “On reflection, it seemed that there were a number of plausible reasons why not adopting a strategy for some individuals might be reasonable, e.g. diversion of time and money from a potentially more productive area into a less productive area for one. Likewise, on a societal level, some might argue that the attention to preventing adult weight gain diverts public and private funding into largely futile areas, contributes to anti-fat attitudes, eating disorders, etc. It may also be thought to contribute to the idea that preventing weight gain is relativity easy and failure to do so reflects a character flaw, thus diverting funding from research on prevention in adults into programs.On looking over the review, I couldn’t see where this issue was a key question or was part of the study design. So I was wondering how this conclusion was reached. Could you let me know?”

The author admitted, “We did not specifically examine whether weight gain prevention should be attempted or not. I think that the statement at the end of the report that you refer to is trying to reflect the national priorities regarding preventing weight gain set forth in Healthy People 2020 in light of the obesity epidemic. (Emphasis added.) There are potential pros and cons with supporting weight gain prevention. You have listed out several potential cons in your email, but I do think that we need to weigh them against the potential benefits such as reduction of or improved control of weight-related conditions like hypertension, diabetes, joint pain, etc. that cause substantial morbidity in our country. Since we do not have good evidence that any particular program successfully leads to weight gain prevention, we cannot really know yet whether these programs lead to benefits or harms.

Ultimately, I think the take away from the report is that we need to do more research to better understand how best to prevent weight gain, and to determine what are the benefits and harms of successful weight gain prevention programs. Such information might make it easier to understand whether this should continue to be a national priority.”

Fair enough, but that’s not what the review’s conclusion states. Supporting Healthy People 2020 is not AHRQ’s job. While we are not even half-way between Healthy People 2010 and Healthy People 2020, we know that the adult population with obesity is increasing and the adult population at normal weight is decreasing. This might be reversed but there are not any secular trends out there providing much hope.

At some point in the near future, a policy-maker (or the head of a supermarket chain) is going to point to this report as ‘evidence’ that preventing gaining weight is achievable and everyone can do it. AHRQ cannot control how their reports are used. But they need to keep straight that their evidence is meant to inform policy decisions; not that policy decisions should spin evidence reports.

Recently, Francis Collins, Director of the National Institutes of Health and Griffin Rogers, Director of the National Institute on Diabetes, and Kidney Diseases stated in an article, The next generation of obesity research: No time to waste:

Americans spend more than $60 billion annually on weight-loss programs and products, yet scant evidence exists that these expenditures translate into lasting weight loss. Given the health consequences of obesity, the United States needs rigorous data on what approaches can help achieve and maintain healthy body weights over the long term.

Indeed, research has provided—and will continue to provide—the foundation of evidence needed to confront the obesity crisis in the most effective and efficient manner. Among the many questions to address are: Why are some individuals more susceptible to obesity? Can the knowledge of biology and behavior be used to develop and better target intervention strategies? What current strategies really work? For whom? Can these approaches be scaled up?

To address this need, research must proceed swiftly on 2 parallel fronts. The first is to devise practical and effective strategies for intervention, with special emphasis on preventive strategies that can be rapidly implemented in health care and community settings.

Likewise, in 2011, Luckner, Moss and Gericke wrote, “responding to the obesity epidemic requires robust evidence to help prioritize the allocation of scarce resources to preventive interventions.”

In this critical area, AHRQ needs to stick to the rigorous evaluation of scientific studies; not engage in buttressing failing public policies.

 

 

AMA Considers Recognizing Obesity as a Disease

June 17th, 2013

At their annual meeting this week, the American Medical Association’s governing body, the House of Delegates,  will consider a resolution recognizing obesity as a disease. As they say, we wait with baited breath.

In 2009, the AMA declared that obesity should not be a condition qualifying for disability status. (See post, How the AMA Got It Wrong, Sept. 27, 2009)

In 2012, the American Association for Clinical Endocrinology recognized obesity as a disease. The Obesity Society did so in 2008. This is the white paper of supporting evidence. See also my paper in 2001: Obesity as a disease entity

The Social Security Administration recognized obesity as a disease in 1999. The Internal Revenue Service determined that costs for the treatment of obesity were medical costs eligible for the medical deduction on individual income taxes in 2002. In 2004, the Centers for Medicare and Medicaid Services effectively recognized obesity as a disease by removing language to the contrary from their coverage manual.

 

Final Rand Report on Employer Wellness Now Available

June 13th, 2013

The final Rand Inc. report on Workplace Wellness Programs is now out. The report was mandated by Congress and provided to the Departments of Labor and Health and Human Services. It was leaked to Reuters shortly before finalization of the Administration’s regulations implementing the employer wellness provisions of the Affordable Care Act.

The report is just as negative on wellness programs as Reuters reported. The Rand Research Report is based on a review of the scientific and trade literature, a national survey of employers with at least 50 employees, statistical analysis of health plan claims and wellness program data from several employers. Five case studies round out the report.

The study found that nearly 80% of employers offer nutrition and weight activities, such as Weight Watchers group meetings, weight loss competitions and personalized phone support from health coaches. However, uptake is poor. Fewer than half of employees undergo clinical screening or complete a health risk assessment. Of those identified for an intervention, less than one-fifth choose to participate. For weight and obesity programs, the participation rate is 10%.

The researchers found that, “one year participation in a weight control program is significantly associated with a reduction in body mass index (BMI)(kg/m2) of about 0.15 in the same year, and the effect persists for two subsequent years. As illustrated in Figure S.4, this change in the first three years corresponds to a weight loss of about 0.9 pound in an average woman of 165 pounds and five feet four inches in height, or about one pound in an average man of 195 pounds and five feet nine inches in height.” The researchers note that an average non-participant would see an increase in BMI of approximately 0.5. (Of course, the fourth year data is much worse.)

The Rand report goes on to observe that employers overwhelming expressed confidence that workplace wellness programs reduce medical costs, absenteeism and health-related productivity losses. “But,” states the authors, “at the same time,” only about half stated that they have evaluated program impacts formally an only 2 percent reported actual savings estimates…Our statistical analyses suggest that participation in a wellness program over five years is associated with a trend toward lower health care costs and decreasing health care use. We estimated the average annual difference to be $157, but the change is not statistically significant.”

The authors conclude, “Consistent with prior research, we find the lifestyle management as part of workplace wellness programs can reduce risk factors, such as smoking, and increase healthy behaviors, such as exercise.” They calculate that, compared to non-participants, continuous participation in weight control program for five years would result in a relative weight loss of 10 pounds in an average woman or 13 pounds in an average man.”

This is a rather meaningless calculation. “Continuous participation” assumes continuous motivation, no plateaus and no rebound. Not likely. No where do the authors indicate a familiarity with the well-established physiological propensity for weight regain after weight loss. (See, Weiss, EC, Galuska, DA, Kettel Khan L, et al, Weight regain in U.S. adults who experienced substantial weight loss, 1999-2002, Am J Prev Med 2007;33(1):34-40)

The accompanying figures indicate that employers pay an average of $188 incentive for participation in a program and $ 144 in a results-based program.

One interesting finding used the database of the Care Continuum Alliance, an industry association, and looked at exercise. It found that in the initial year, participation in the exercise program is associated with a significant increase in exercise activities of 0.15 days of at least 20 minutes exercise per week. But it falls off to 0.11 in the second year and has no effect thereafter.

Cite: Mattke, Soeren, Hangsheng Liu, John Caloyeras, Christina Y. Huang, Kristin R. Van Busum, Dmitry Khodyakov and Victoria Shier. Workplace Wellness Programs Study: Final Report. Santa Monica, CA: RAND Corporation, 2013. http://www.rand.org/pubs/research_reports/RR254. Also available in print form.