Posts Tagged ‘The Obesity Society’

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.

 

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 Obesity Society Meeting-Day Two

October 26th, 2009

Today’s sessions of the Obesity Society’s annual scientific meeting covered a lot of ground.  I think the most interesting  was the session on the relationship of cancer and obesity organized by Ruth Ballard-Barash of the National Cancer Institute and Ted Adams of the University of Utah School of Medicine. Christine Friedenreich, Ph.D. of the Alberta Health Services presented a comprehensive overview of the association between specific cancers and obesity, reviewing the published literature for each cancer. At the end, she proposed that obesity was responsible for about 20% of all cancers. If (in an ideal world) obesity levels could be resolved to normal BMIs, she speculated 1.6 million deaths due to cancer could be saved, 2.2 million new cancer cases could be avoided and we could avoid having 5 million persons living with cancer.

Other key presentations addressed the powerful influence of sleep and circadian rhythms, or the lack thereof, on rising rates of obesity. This led one presenter to suggest that we should have our biggest meals at breakfast and gradually reduce caloric input throughout the day to a light salad at dinner. Rena Wing reported on the 4 year results of the Look Ahead Trial which provided persuasive information for intensive lifestyle counseling over less intensive interventions in reductions in body fat and related metabolic indicators.

Sometimes these meetings morph into abstract, perhaps irrelevant, discussions of minutia   among researchers.  At other times, you feel you are witnessing an emerging new insight into obesity and its effects. So it was today in a session, Is There Good and Bad Body Fat? chaired by Richard Bergman, editor of Obesity, and including prominent researchers, Tamara Harris, Michael Jensen (who readers may remember from our conference at the 2008 Republican National Convention) and Sam Klein. Their task was to unravel which fat was bad and which was good. Their presentations covered detailed, precise research into these tangled issues.  Why are there some obese individuals who were, nevertheless, metabolically normal? Why did bariatric surgery resolve diabetes in some cases but not others?  Why does weight loss resolve some metabolic disorders but not others? For many in the audience, these are the cutting edge questions – today – to understand the metabolic sequela of weight gain, insulin resistance, diabetes and cardiovascular disease. The presenters provided exciting new data interspersed with a camaraderie and jocularity which is the realm of highly accomplished and competitive scientists who admire each other’s works but are not going to give them an inch. Bottom line: adipose cell build up in the liver may explain many of the inconsistencies in present views of the obesity-insulin resistance-metabolic disorders axis. But, build up of adipose cell in the liver is hard to measure given today’s technology and bio-statistical resources. On the other hand, there may well be another factor, not yet identified (kind of like dark matter in astrophysics), which modulates the effects of obesity, insulin resistance and metabolic disorders. The large, enthusiastic audience no doubt left with many possible research proposals in mind to unravel this conundrum. Stay tuned, as they say, “we wait with bated breath,” for the next insight.

The Obesity Society Meeting, Day One

October 25th, 2009

This Saturday, October 24 is the “pre-meeting” day which means it is outside the constraints of the Continuing Medical Education limitations on corporate participation. Most participants head right for the Pharmacology update section. This section involves presentations by mainly pharmaceutical company researchers as to where their compounds are on the tortuous path to approval by the Food and Drug Administration (FDA). To researchers, it is a tip-off as to where their research should be going; to competitors, it is an indication of how their compounds may fare. There are not a few investment advisors in the audience looking to where their clients should place bets as to which company’s products may get approved or not.
A cautionary note: This Saturday show is not unlike the paddock at the Kentucky Derby. Some horses look just beautiful; some are not so handsome but have great records; some are nags but just keep moving along. Over the next few days, more details on these compounds eke out in oral and poster presentations. Sometimes the beautiful horses stumble; sometimes the nags win. It’s a horse race.
Today, however, presentations by three pharmaceutical companies and one researcher for a device manufacturer focused on their products in Phase II or Phase III of development. The companies were Arena, Vivus, Orexigen and Amylin. The one device company was represented on the platform by Lee Kaplan of Harvard, commenting on GI Dynamics’s EndoBarrier system.
I was seated among several highly experienced, knowledgeable obesity researchers and, frankly, keyed off their reactions. The Arena information was impressive but not inspiring. The Vivus presentation showed real promise and indicated a good bet for approval. The Orexigen data was impressive but not overwhelming. Amylin’s products were at an earlier stage of development and should not be compared with those at later stages of development. However, they seem to have a good track on products which may not have the side effects of the other compounds. The GI Dynamics data involved a new surgical intervention which, while promising, had a number of issues around delivering the product.
In short, a lot more needs to be discussed about these compounds. However, these presentations were inspiring to the audience of researchers and clinicians that a new generation of therapies are closer than we think. The Devil is, alas, in the details and over the next few days more details on these and other products will emerge. Stay tuned.