Posts Tagged ‘ASMBS’

ASMBS 2012 Guest Speaker

March 3rd, 2012

I am very honored to be one of the Guest Speakers at the ASMBS 2012 Annual Meeting June 19th in San Diego. My talk is “Obesity from 30,000 feet: Toward a Realistic Obesity Policy.”  If you are attending the meeting, please do stop by. Guest Speakers | 29th Annual Meeting of the ASMBS

FDA Panel OKs Qnexa

February 23rd, 2012

Yesterday, the Endocrinologic and Metabolic Drugs Advisory Committee  voted overwhelmingly, 20-2, in favor of approval of Vivus Inc.’s anti-obesity drug, Qnexa. It was one heck of a surprise.

The morning session included presentations by the company and the FDA staff on the effectiveness of Qnexa and, especially, the safety profile. The safety issues involved the issue of whether additional birth defects, particularly oral clefts, would result from wider administration of topiramate and whether phentermine contained a risk for cardiovascular events. The panel members were clearly wrestling with understanding the data. The company presented a very comprehensive Risk Evaluation and Management System (REMS) plan to reduce exposure to the drug by women of child-bearing potential. During the discussion, committee members and the FDA expressed concern that the REMS program might be too restrictive. They observed that if access were too limited, patients could do what they are doing now – use the two drugs in the generic forms off-label for obesity treatment.

Considering the cardiovascular risks, they were concerned about the relatively weak,  but nevertheless present, sign of increased heart beats per minute and what that meant. This indicated a cardiovascular outcomes trial (like the SCOUT study for Meridia). The issue was whether the study would be done prior to approval or post approval. The key comments were made by Dr. Sanjay Kaul, usually a hawk on the obesity drugs, who opined that having the trial conducted post-approval would not be unreasonable. The effectiveness of the drug, about a 10% weight loss over a year, was the tipping point.

During the public witness part of the meeting, I testified, along with Ted Kyle for the Obesity Society, Denise Bruner for the American Society of Bariatric Physicians, Chris Gallagher for the American Society for Metabolic and Bariatric Surgery and Joe Naglowski for the Obesity Action Coalition. Ever since Qnexa was turned down in July 2010, we had been encouraging each other to testify and hold up the case for recognition of obesity as a disease and requiring additional tolls to fill the ‘treatment gap’ between lifestyle changes and bariatric surgery.

We huddled together as the votes were cast. The discussion among the panel members all day was of the ‘one the one hand on the other hand’ type. We expected a close vote.  So, we nearly fell over at the 20-2 vote in favor of approval. Of course, the FDA has the final word and it does not have to follow the recommendations of the panel. Nevertheless, it seems more likely than not that the FDA will approve.

At the end of day, I felt that the long shadow that the phen-fen debacle has cast over the FDA might be lifting and that the panel may have achieved a higher recognition of the enormous implications of our ever growing obesity epidemic.

Arena Pharmaceuticals and Orexigen Therapeutics  are still in the game with their drugs. While this positive vote, on the one hand may be good news for them, it may also set the effectiveness bar at a height their drugs cannot meet. Time will tell.

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.”