Posts Tagged ‘safety’

Overweight Air Passengers At Risk

May 8th, 2012

A New York Times article reports that airplane seats, designed for passengers weighing 170 pounds, may not protect overweight passengers in a crash. See NYT: scientists-ask-are-airplanes-safe-for-overweight-passengers?


The Exciting Recent History of Bariatric Surgery

November 8th, 2011

David Flum’s Bariatric Obesity Outcome Modeling Collaborative at the University of Washington School of Medicine (funded by the Department of Defense and the National Institute of Diabetes, Digestive Diseases and Kidney) recently published a study on the use, safety and cost of bariatric surgery before and after Medicare’s National Coverage Decision (NCD) expanding bariatric surgery in 2006.

The Medicare NCD expanded Medicare coverage of new surgeries, particularly laparoscopic gastric banding and laparoscopic gastric bypass when done in centers of excellence approved by either the American College of Surgeons (ACS) or the American Society for Metabolic and Bariatric Surgery (ASMBS). The standards of the two societies differed somewhat but both certified both hospitals and surgeons and both were based on having large volumes of cases. In addition, the ASMBS system, implemented by the Surgical Review Corporation, requires participation in a robust database, called BOLD, and a five-year follow-up of patients. 

The number of surgeries dropped after the NCD but soon regained their pre-NCD levels. There was a significant shift to the laparoscopic gastric band after the NCD was issued. The mean age and mean comorbidity index increased slightly. The study found that outcomes improved after the NCD. The 90-day mortality rate dropped from 1.5% to 0.7% after the NCD. There was a significant reduction in the number of sites and surgeons performing the surgery. The improvement in patient safety seems mainly due to the shift to the laparoscopic gastric band rather than centers of excellence themselves. Overall, costs appear to have gone down across all procedures. The authors note that the durability of weight loss due to surgery is still an issue as the bands are showing a disturbing rate of removal in several European studies. The Use, Safety and Cost of Bariatric Surgery Befor… [Ann Surg. 2011] – PubMed – NCBI

 The paper brought me back to a particular point in time in my professional career which I would like to share with you. In the early years of the new century, there was an intersection of two threads in obesity and public policy. On the one hand, bariatric surgery was reeling from bad publicity of terrible stories of botched operations. Insurers were dropping coverage of bariatric surgery all across the country. Malpractice insurers were upping their rates. The surgeons were in a crisis.

On a totally separate track, as director of the American Obesity Association, I had persuaded the Internal Revenue Service to recognize obesity as a disease in April of 2002. Subsequently, I took the same arguments to the Centers for Medicare and Medicaid Services (CMS) which had a policy statement that obesity was not a disease. On July 15, 2004, Medicare withdrew that statement, recognizing obesity as a disease. Soon thereafter, I met with Steve Phurrough, the head of the CMS center for coverage and analysis, and asked him what was CMS going to do next. “Bariatric Surgery,” he replied. CMS scheduled a Medicare Coverage Advisory Committee (MCAC) hearing for November 4, 2004 to look at bariatric surgery.

I contacted ASMBS (or ASBS as it was then called) as well as five companies involved in bariatric surgery. A couple of the companies did not have products on the market but were in developmental phase. I felt it was important they were at the table. I read them all the riot act. If everyone went off on their own, bariatric surgery was not going to fare well at the MCAC hearing. If we focused on what was best for the patients, who the patients were and what they needed, we would do ok. I want to say it was an easy sell. Some got it, some did not.

So the two threads crossed: crisis for bariatric surgery and an emerging consensus to treat obesity as a disease. At this point, the presentation for bariatric surgery at the MCAC was in the hands of a few veterans: Walter Poires, Henry Buchwald, Harvey Sugerman, and Neil Hutcher, stand out in my mind. As they were putting the presentation to MCAC together, they were also working within ASBS to create the Centers of Excellence movement. The stakes of such a move should not be understated. Such an effort means saying to loyal, dues-paying, members that their colleagues felt they are not good enough to keep doing what they have been doing for years. The emotional and professional price could be high. Participating in the MCAC hearing were the next generation of leaders, Bruce Wolf, Robin Blackstone, Christopher Still, to name a few.

At the end of the day, CMS expanded coverage for bariatric surgery, much to the dismay of some. ASBS created its centers of excellence of program, implemented by the Surgical Review Corporation. (I went on its board of directors for a few years.)

Now, we see from Flum’s report what we had hoped for: patients have access to a safer, cheaper procedure. I am not aware of any medical specialty which has overcome its quality problems so aggressively in such a short period of time. When people talk about how hard it is to achieve change, I think of what ASMBS did in a few short years.

Subsequent research may challenge this but subsequent technological improvements may enhance surgery as well. It isn’t always that one gets to see whether an earlier effort has played out as you hoped. As my son would say, “Sweet.”

Marketing Efforts for Anti-psychotics Brings on Lawsuits

October 3rd, 2010

October 3rd, 2010 New York Times contains a long analysis of the problems in the marketing of antipsychotic drugs. These efforts have included ghost-writing medical journal articles, under-the-table financial inducements to medical speakers and generally pushing to expand the diagnostic criteria while burying side effects. These efforts have reaped huge profits for the companies but headaches as well in terms of lawsuits and government investigations. One of these cases involves AstraZeneca’s Seroquel. Documents revealed in lawsuits show that the company tried to hide the risks of weight gain and diabetes with the drug. One study showed that Seroquel users gained 11 pounds a year! Antipsychotic Drugs – Side Effects May Include Lawsuits –

There are two lessons here. For one, this kind of behavior by pharmaceutical companies poisons the well for obesity drugs. Many in the medical community and at the FDA see in obesity drugs the same kind of fertile ground for abuse as in anti-psychotics. The second observation is that, for this category of anti-psychotics, the FDA tolerates safety problems which would be the death-knell for obesity drugs. Not the least of these safety signals is weight gain. The FDA is perfectly comfortable approving drugs which increase body weight and disapproving drugs which cause weight gain. That this pattern is so accepted by the medical community is a stunning. Why does medicine tolerate this?