The buzz now, in size acceptance spheres and elsewhere, is the FDA’s presumed lowering of the BMI threshold for bariatric surgery involving laparoscopic bands. There is discussion among weight loss maintainers and maintainer aspirants at Lynn’s Weigh. It’s interesting (but not surprising to readers here) that Lynn and many of her commenters are as uncomfortable with this presumed decision as the people discussing this issue at size acceptance sites, such as Fierce Freethinking Fatties and Big Fat Blog. I tried to enter the fray at BFB, and just made a mess on the comments page with my lengthy URLs, So I will give my thoughts (and links) here.
First, let’s clear something up. It’s not a done deal. The FDA rarely bucks a panel’s recommendation, but it can, and it hasn’t made a final decision yet. It’s as though a motion has been made, and lacking discussion, it will pass in a few months’ time. Maybe we need to enter the discussion.
In short, I think the FDA is being pushed too quickly, and with inadequate and premature evidence. If it proceeds, then it does so on the recommendation of its Gastroenterology and Urology Devices Advisory Panel. While I’m sure these are fine people, it can be argued that the interests of bariatric surgery are well represented and consumer concerns may be, er, less so.
The panel of 14 includes general surgeons and other medical experts, as well it should, since it is charged with making recommendations on a variety of surgical devices for GI and urology procedures. But more specifically, at least five of the panelists are bariatric surgery True Believers:
- Jon C. Gould, Chief of Minimally Invasive and Bariatric Surgery, University of Wisconsin
- Thomas H. Inge, Director of Cincinatti’s Surgical Weight Loss Program for Teens since 2004 and has performed over 135 minimally invasive weight loss procedures for adolescents during that time
- John G. Kral, professor of surgery and a recognized obesity expert, having established the NIH Obesity Research Center at Columbia University, among other obesity-related accolades
- Walter J. Pories, Director of the Bariatric Surgery Research Program at East Carolina University
- Jeffrey L. Zitsman, Director of the Center for Adolescent Bariatric Surgery at the Morgan Stanley Children’s Hospital of NY Presbyterian/Columbia University Medical Center
Moreover, the panel’s chairwoman is significant enough a shareholder in Allergan to recuse herself from one of the votes that moved the panel toward its approval recommendation. Give her credit, she might have been able to keep that secret, had she chosen not to reveal it. And, on top of all of this, the “Patient Representative,” Melanie G. Coffin, is described as having “personal experience with obesity and weight control issues. In addition to her own weight loss journey, Ms. Coffin has spent 15 years working with as many as 500 people a week that were dealing with issues of weight, health, behavior, exercise, and nutrition.” Clearly, she comes to the data with a pre-formed opinion.
All of this said, representing the skeptics is an attorney, E. Francine Stokes McElveen. The other six, biographies would indicate, may come to the process with some objectivity.
News stories reveal that the recommendation went forward on an 8-to-2 vote, which I take to mean that some people were not in attendance, since an “abstain” or recusal would have been recorded as such. The panel decided to push the FDA toward approving lapbands for increasingly smaller BMIs based on this report. Does it bother anyone else that there are no authors? Not on the cover page. Nowhere. Please look for me. Maybe I’m missing something, but all I see is that there is no one taking responsibility. Is this de rigueur with scientific studies at the heart of important government decisions like this? If so, is it ethical? The report was prepared, apparently, by some anonymous scientists from Allergan. Why didn’t Allergan’s Vice President of Clinical Research and Development, Frederick Beddingfield, MD, put his name on it front and center?
The reason we may assume the report is authored by Allergan is because it is based upon this clinical trial initiated and conducted by Allergan scientists. According to its press release to stockholders, Allergan conducted this study “under an FDA-approved Investigational Device Exemption,” which I take to mean exemption from normal scientific controls and protocols, but correct me if I’m wrong. The study will not be complete until 2012. The 149 participants in the study (one fewer than projected originally) were cherry picked (the lay term for nonrandom selection) and without a control group for comparison. For this report, they had received their bands and roughly one year of follow up.
Why are we rushing? Do we not care to know the fate of these people in 2012? Perhaps we think so many people with BMIs between 30 and 40 will keel over dead between now and then, and, hence, we MUST rush! Or are we afraid that maybe the subjects of the trial may regain weight by then or suffer other regrettable side effects that wouldn’t be supportive of approving this lowered BMI threshold?
I make this rant now, a little late to the discussion, because it’s hard to stay on top of all my skepticism while stuff keeps churning. Now maybe I need to take a serious look at the panel and proceedings surrounding today’s big news, the impending FDA approval of the anti-obesity drug Contrave. Yeesh. It’s exhausting. Maybe I’ll leave that investigation to someone else.
Meanwhile, if you have something to say to the FDA, you may say it here (thanks, DeeLeigh at BFB, for the contact info).
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993