What Allergan calls "obesity intervention products" are expected to bring in $220 to 240 million in NET sales. That means what they will earn beyond the cost of production. This expansion is estimated to have created a new market of over 26 million Americans, quite a significant boost to their potential sales because only about 15 million (several sources, see Time Feb 19, 2011) were eligible under the old standards.

Going from 15 million potential customers to 41 million customers is a 173.33% increase in a market in which Allergan basically has a monopoly. In other words, our government handed over to Allergan an incredible increase in market with a simple vote.

The justification for this includes the idea that such surgery is needed because diets do not work.  In fact, one of the prerequisites for getting the surgery is to have failed to lose weight after trying to diet.

The LAP-BAND is intended to be used for weight loss in adults who have not lost weight using non-surgical weight loss methods. The newly-approved indication is limited to patients with a BMI of 30 to 34 and at the highest risk of obesity-related complications. This represents a narrower indication than originally sought by Allergan. The company had also proposed to expand the indication to include people with a BMI of 35 to 39 and no obesity related condition. Patients using the LAP-BAND must be willing to make major changes to their lifestyle and eating habits. (From FDA Press Release dated Feb 16, 2011)

But notice that weight loss surgery doesn't work unless eating habits change. Yes, the fact that most people throw-up if they eat more than a few ounces of food has a tendency to keep one on the diet, but the surgery alone does not work. This dirty little secret is not offered often in weight loss surgery marketing. Neither are all the complications that come from the surgery.

But the profits do not stop with Allergan, or even with the hospitals and surgeons who are making millions, if not billions, collectively from the surgery. This kind of thinking benefits all of the weight loss industry. You have to demonstrate you've tried to lose weight before you can qualify for the surgery. This includes dieting, taking medication and other weight loss and/or lifestyle schemes.

If we follow the money, it starts with diets and gym memberships, moves to pills and other interventions, then to surgical interventions and then to post-op care, which can be expensive and overwhelming, including everything from the supplements one  has to take for life to make-up for the lack of absorption that your stomach can no longer affect to plastic surgery for loose skin (Allergan, by the way, also makes breast enhancement prosthetics). The only way this market works is for the consumers to constantly blame themselves for the failures of these products and schemes.

Study showing that weight loss interventions are ineffective and harmful published - January 24, 2011

The online scholarly publication, Nutrition Journal published an article "Weight Science: Evaluating the Evidence for a Paradigm Shift" by Linda Bacon of University of California, Davis and Lucy Aphramor of  the Applied Research Centre in Health and Lifestyle Interventions at Coventry University in the United Kingdom.

This meta-study reviewed major studies on dieting, weight loss, and Health at Every Size^SM and examined the basic assumptions behind weight-centered interventions for both prevention and care. Similar to the lap band decision, this data review examines the implications of what to do if diets do not work. The implications drawn by the authors, however, are far different from the FDA decision.

Bacon and Aphramor make a compelling case that promoting weight loss or weight-focused programs fail to be effective and may cause more harm than good. In other words, a weight-centered paradigm is unethical. Beyond the questions of efficacy and unintended h

arm, there are questions of social justice, in that weight-focused programs promote inequality and undermine efforts to fight for equality. Finally, they make the case that a weight-centered paradigm is costly, with nearly 31% of the population being misdiagnosed when BMI was used as a screening parameter.

Perhaps, like all studies, their case needs to be scrutinized with skepticism, but what interests me most as a sociologist is two things.

First, no national discussion has broken out regarding this study. This is radical stuff. It is saying that a 57.8 billion dollar a year industry is unethical. The use of the word "paradigm" is accurate. This is a major shift from current accepted practices and wisdom. In a meritorious world, this should have been front-page news.

Press releases have been sent and, for a short period of time, the article had a "most viewed" status on Nutrition. But, except for some small stories or articles here or there, the media didn't pay much attention. I googled the title of the article and saw a little over 30,000 hits. The first few pages were hits for Linda Bacon's website and other HAES-friendly websites. I googled the title in just a news search and received no results.  I googled "FDA expands indications Lap Band" and got 180,000 hits with a news search showing 535 articles. The FDA announcement was constantly addressed on the 24 hour news channels for 2 or 3 days after the announcement, as well as all four network morning shows having some sort of story.

Second, while an obvious profit motive and conflict of interest existed, the FDA used data generated from Allergan to make its decision with little marking of that motive or conflict. In fact, the press release from the FDA announcing the expansion referred to "a recent US study" without disclosing that Allergan was one of the financial sponsors of that study. (source Women's News online). Bacon and Aphramor disclosed that they indeed make money from promoting HAES, usually through speeches and books. But this "profit" is small, probably not more than 4 or 5 figures annually and usually goes into more research and covers costs for attending conferences and sharing their research work. Allergan predicts NET sales in 9 figures ($220 to 240 million in 2011) and this will most likely keep growing. Yet they were not required and the FDA did not announce their conflict of interest and profits from this decision.

 

Money Talks: What does the money tell us?