FYI: a new preventive health measure

A new intervention has been added to the field of public health and preventive medicine: bariatric surgeries. This is being disseminated worldwide pretty much simultaneously and offers insight into the marketing of disease prevention.

Consumers and healthcare professionals, alike, can’t help but notice that media and medical journals have been presenting a steady stream of positive examinations of bariatric procedures. Critical reviews are sparse, despite the weak supportive research and the preponderance of the evidence showing greater risks than benefits for significant percentages of patients. While bariatric procedures have been advocated for the treatment of “obesity-related” health problems, many Americans probably first became aware of them promoted as a cure for diabetes with the CBS 60-minutes special this spring.

New medical specialty: diabetes surgery

This special episode introduced the new field of “diabetes surgery,” founded by Dr. Francesco Rubino, who also created the International Diabetes Surgery Task Force and became the head of the country’s first academic medical program dedicated to diabetes surgery at New York-Presbyterian Hospital/Weill Cornell Medical Center. After the first Diabetes Surgery Summit held in Rome last year, the bariatric surgeon trade organization changed its name to the American Society for Metabolic & Bariatric Surgery, to better reflect its new mission of promoting bariatric surgeries as treatments for diabetes and other metabolic conditions, and to establish diabetes surgery a new surgical discipline.

There has been no sound, randomized controlled clinical trial to show any bariatric procedure to cure diabetes or do more than result in short-term lowering of blood sugars, or that the surgeries have a positive benefit-risk ratio in clinical outcomes for most patients. Nor does anyone know how lap band and bypass surgeries might work to cure diabetes or, more importantly, understand the various hormones in the gastrointestinal system and the long-term effects of impairing or altering their function. There are a number of theories of what works and why. [Reviewed here.] One theory is that gastro-intestinal surgery might affect the incretin hormones and the GLP-1 pathway and promote pancreatic islet growth, much the same way that the diabetes drug, Byetta, works.

— Yes, this is the same Byetta that the FDA has issued repeated warnings and a few weeks ago called for stronger label warnings because of reports of severe hemorrhagic or necrotizing pancreatitis and the deaths of six patients on Byetta. As Dr. David Cummings, an associate professor at the Division of Metabolism, Endocrinology and Nutrition at the University of Washington in Seattle, and colleagues had critically written in the New England Journal of Medicine, at least with a drug, should a problem like nesidioblastosis [another life-threatening complication, reviewed here] occur, it’s far easier to resolve by discontinuing the drug, than trying to reverse the bypass surgery. But no one would say that diabetes medications that help to control blood sugars are “cures” for diabetes or that the patients are no longer diabetic.

Diabetes surgery as preventive medicine

Many Canadians may have first learned of bariatric surgeries as preventive medicine on July 22^nd, when the Ontario Health Ministry announced its new $741 million Diabetes Strategy. This program includes a $150 million investment over the next four years to establish a government electronic diabetes registry to monitor and manage all Ontarians with diabetes — similar to New York City’s, which was extensively reviewed in a recent issue of Annals of Internal Medicine, covered here — and is the first step in Ontario’s establishment of nationalized electronic medical records (e-Health Strategy) that intends to include the medical records of all citizens by 2015.

Ontario’s Diabetes Strategy also increases expenditures for bariatric surgeries by $75 million, to double the surgeries within two years, with further increases planned thereafter. Dr. Arya M. Sharma, M.D., president of the Canadian Obesity Network said he’d lobbied the Government intensely for this initiative and was “also the Clinical Co-Chair of the Health Technology Utilization Guidelines group that was contracted by the Ontario Health Ministry to prepare recommendations for Bariatric Surgery in Ontario.” The bariatric industry hopes to expand bariatrics because “obesity treatment IS prevention!,” he said, and “the sooner we can get the services in place across all of Canada, the better for everyone.”

International meeting on bariatrics' place in public health policy

But an international conference may bring the greatest media focus on diabetes surgery around the world. The 1st World Congress for Interventional Therapies for Type 2 Diabetes was held this week in New York City, bringing together public health officials from nations around the world with professionals in the bariatric and diabetes industries to organize an emerging discipline of diabetes surgery.

As Dr. Jesse Roth, Congress faculty member and diabetologist at the Feinstein Institute for Medical Research and the Albert Einstein College of Medicine of Yeshiva University in New York, said in a press release: “Surgery has arrived like a comet across the firmament of diabetes and obesity — unexpected, brilliant, with great promise for the future. Teams of talented researchers are moving ahead to define the role of surgery in the treatment of both of these scourges.”

A special session under the auspices of the International Diabetes Surgery Task Force reported on the clinical practice guidelines written at the Rome summit, “which includes recommendations for the surgical treatment of diabetes.” Among the other panels, Dr. Rubino with the Presbyterian Hospital/Weill Cornell Medical Center discussed broadening the criteria for bariatric surgeries to include less obese and non-obese diabetics, and the need to implement widely accepted international guidelines. As the media release stated: “In spite of the limited evidence, diabetes surgery is already being utilized throughout the world, even in non-obese patients.”

Dr. Francine Kaufman, head of the Center for Diabetes, Endocrinology and Metabolism at the Children's Hospital discussed the role of bariatric surgery for the “growing rate of obesity and diabetes epidemic in adolescents.” [Evidence surrounding teen surgeries were critically reviewed here.]

During another highlighted session of the Congress, according to the program, “faculty, including health economists and top health authorities from United States and around the world, will discuss economic and social implications of surgical treatment of diabetes. New data from major medical and economic journals will be presented showing that diabetes surgery can benefit individual patients and actually represent a potential cost-savings.” [Cost savings research was reviewed here.]

The key goal of this international meeting, however, was to organize to promote bariatrics to government health agencies. According to the program:

The Congress aims to create a forum for the medical community to work with health policy makers, including top public health authorities and insurers from the U.S. and around the world. The overarching aim is to craft an agenda of health policy initiatives to seize the opportunity offered by gastrointestinal surgery.

According to the program, “led by visionary sponsor Covidien, the Congress has received support from the medical device, biotechnology, and pharmaceutical industry.” The sponsors of the World Congress included: Covidien, Ethicon Endo-Surgery, 3 Peaks Consulting, Allergan, GI Dynamics, GlaxoSmithKline, Metacure, Olympus, On-Q Pain Relief System, Power Medical Interventions, Amylin, Lifescan, Obesity Care News Pfizer, Sanofi-Aventis, Karl Storz Endoscopy, and Synovis.

The endorsing agencies that participated in the Congress represented the bariatric industry and diabetes societies from around the world:

These are the entities advocating bariatrics as preventive medicine and a treatment for diabetes, drafting clinical guidelines for the new discipline of diabetes surgery, and helping to shape public health policies. Disclosure statements don’t really seem to make a difference in the readiness to accept diabetes surgery in media and politics. Hopefully, they do prompt medical professionals and consumers to examine the research with extra care.