Health Letter, November 2013
At the annual meeting of the American Medical Association (AMA) on June 18, 2013, 60 percent of the 457 voting delegates, representing state and specialty medical societies, voted to classify obesity as a disease.
This vote was anything but unanimous and was indeed surprising, given an extensive report released previously by the AMA’s Council on Science and Public Health (CSPH) that declined to recommend classifying the condition as a disease.
Background on CSPH report
The CSPH report, titled “Is Obesity a Disease?” was released in 2013 and was the result of an extensive review of existing medical literature. The council’s conclusion, which was presented to the AMA’s voting members at the 2013 annual meeting, was that there is not enough information to determine that obesity is a disease.
For one thing, the council stated, the definition of obesity relies on the body mass index (BMI), an “indirect and imperfect measure of body fatness.” It also is an imperfect measure of individual health. Some people with low BMIs (less than 25) can still have excess adipose (fat) tissue and health problems, while some people with high BMIs (greater than 30) may not have excess body fat or, if they do, may still have normal insulin, blood pressure and cholesterol levels. Thus, an individual who makes changes to achieve a healthy lifestyle but doesn’t see a change in BMI might get discouraged and believe himself to be “sick” even though his overall health had improved.
An analysis of 97 studies covering 2.88 million people, published in the Journal of the American Medical Association in January 2013, found that people who were termed “overweight” were actually 6 percent less likely to die than those of so-called “normal weight” over an identical time period. The conclusion some commentators have drawn is that, especially for those middle-aged or older or already sick, some extra weight could have a beneficial effect. These observations are part of the concept of the “obesity paradox:” As BMI increases, diseases like hypertension, heart disease and diabetes become more common, but mortality risk does not seem to increase along with them – at least until people reach an extremely high BMI. (For more on the obesity paradox and the imperfect science of BMI, please see “‘Normal’ Weight and Aging,” also in the November issue of Health Letter.)
In addition, the very definition of “disease” is debatable. The AMA’s CSPH said that there was no “single, clear, authoritative and widely accepted definition.” In the council’s view, the more relevant question was: “Would health outcomes be improved if obesity is considered a chronic, medical disease state?” An affirmative answer, the council concluded, could not be provided at this time.
There are a variety of consequences of classifying obesity as a disease.
One possibly positive outcome might involve greater levels of government and industry investment into causes and treatments of obesity. Patients also would be more likely to get reimbursements from insurers to help cover treatments.
However, the Food and Drug Administration (FDA), with obesity classified as a disease, would likely be under greater pressure to approve more medications. This has a number of potentially negative ramifications, including an increasing focus on a decrease in weight rather than improvements in health. In addition, an increase in the number of medications on the market would be expected to serve as an encouragement for physicians to prescribe drugs and for patients to expect to be treated.
Since all medications have the potential to cause adverse effects, just having more medications available for losing weight is by no means a guarantee of increasing health. In fact, the opposite is likely. An increasing emphasis on drugs and surgery could lead to a decrease in emphasis on physical activity and healthy eating, prime factors in improving one’s overall health. People may assume that if their obesity is considered a disease, their healthful behaviors may matter less, thus decreasing their motivation for change. There also might follow a new awareness that it isn’t obesity per se but the metabolic changes that can come as a result that is the problem.
Interviews with physicians show that those who voted to classify obesity as a disease did so for many reasons. Many were encouraged that insurers might pay for obesity treatment, which is not currently the case.
Others stated that such a categorization would help them to “better serve” their patients. One pediatrician, for instance, thought that it would be easier to tell the parents of his patients that he was treating a disease as opposed to telling them that their “child eats too much or doesn’t exercise enough” (although this is exactly what needs to be said!). A cardiologist interviewed looked forward to more effective fundraising, as “[f]undraising around a condition that’s thought to be a [sic] lifestyle-driven is not as easy.”
The director of the Arthritis and Musculoskeletal Treatment Center at the Cleveland Clinic in Ohio was delighted with the result, because she felt that she would finally be able to prescribe arthritis drugs at higher doses. Her rationale was that because some arthritis medicines end up stored in fat cells, they are rendered less effective, but a “diagnosis” of obesity might prompt the FDA to raise the dosage they allow. However, an increased dosage is almost guaranteed to increase the incidence of adverse events associated with the drugs.
Fortunately, not all physicians were enthusiastic. A nephrologist at the University of Chicago interjected a more nuanced opinion: We understand very little about obesity, it has no specific cause or treatment, and we still don’t fully understand why some people stay slim and others get obese. Thus, he agreed in essence with the CSPH that it was premature to categorize obesity as a “disease.”
Drugs for treating obesity
Before the FDA approves a drug that is meant to treat obesity, the agency requires evidence of statistically significant changes in weight in individuals participating for at least one year in a clinical trial. FDA requires that there must be either an average weight loss of 5 percent in the treated group as compared with the untreated group (those taking a placebo), or that at least 35 percent of treated patients lose 5 percent of their body weight.
Obesity drugs have a history of safety issues. Two previously approved drugs, dexfenfluramine and sibutramine, were withdrawn from the market by the FDA for safety reasons. However, there are currently three FDA-approved drugs for treating chronic obesity still available: One is orlistat (brand name: Xenical) which has been on the market since 1999. Two others were approved in 2012: one, a combination of phentermine and topiramate (brand name: Qsymia) and the other, locaserin (brand name: Bleviq). Although they all met the FDA’s requirements for approval, all can cause adverse reactions, and patients eventually regain some of the weight they lose, even while still taking the drugs. Not everyone who takes them loses weight and a “substantial” percentage of patients withdrew from the studies before the year was out.
WorstPills.org, a product of Public Citizen’s Health Research Group, details the serious risks of these diet drugs and warns subscribers not to take them.
What other groups have to say
In 2012, the Institute of Medicine, an arm of the National Academy of Sciences that makes independent, evidence-based policy recommendations, issued a report advocating for obesity prevention that emphasizes physical activity and increased availability of healthy food and beverages. The report outlined the roles that can be played by school and health care providers, insurers and employers.
The U.S. Preventive Services Task Force, an independent panel of nongovernmental experts, also has recently released recommendations: one for screening and management of obesity in adults (18 years and older) and another for screening for obesity in children and adolescents (6 to 18 years of age). Both of these reports focused on diet, physical activity and behavioral counseling. None recommended drugs or surgery.
The question now is: What will the American public decide? Will the “quick fix” solution promised by risky drugs and surgical procedures outweigh safer, healthier and more permanent lifestyle changes?