DebraSY

Not so Fast, FDA!

In Weight-Loss Maintenance on December 8, 2010 at 9:55 am

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

1-888-INFO-FDA (1-888-463-6332)

webmail@oc.fda.gov

Advertisements
  1. I’ve had a quick glance at the proposal, and the first thing that strikes me is how badly referenced it is. Particularly in the introduction where they give back ground to obesity; not one of the statements they make is backed up by a reference to a relevant paper. Which to me is very fishy. Also the way they mention environmental and genetic factors in obesity but don’t go into any detail, and again no references.

    I’m a masters chemistry student, and if I put in a paper like that I would fail, simple as. Its disgusting that a paper like that is being used as evidence for life changing surgery.

  2. They might fear that a few of those people with current weighs below 30 BMI could starve to death.

  3. I’m not joking about starving to death. Malnutrition could kill one of these people with a lap band. They could not be getting enough calories to live or the right types of nutrients through. Many people look absolutely skeleton like at weights at the higher end of the normal BMI range. BMI doesn’t work for all individuals.

    My grandfather was put in a hospital because they feared he would starve to death and his weight was in ‘normal’ BMI range. He looked absolutely frightful.

    • Interesting, Lillian. I hadn’t mentally taken it that far. It is possible. While banding is presumably reversible, it can get embedded and create a permanent obstruction to nutrition. Hmmmm.

  4. Well I just think it is terrible. What is the long term success rate on people of higher weights that have it done? I keep saying that ‘they’ are just giving the people what they want (bad food, bad surgery, etc) but honestly, is that how whole civilizations collapsed–they just gave the people what they wanted?

    • I think there’s wide agreement that there haven’t been good studies on the long-term success rates for any kind of weight loss surgery. Weight loss surgeons’ have less-than-stellar record keeping and often lose touch with patients after very short follow-up periods (given the seriousness of the operation).

      “They” are, indeed, giving people what they think they want and saying it’s for health’s sake. But at a 30 BMI with only one comorbidity, is it really a question of health or a question of vanity and commerce? Comorbidities can be addressed without damaging a person’s digestive system. Sometimes those treatments even lead to some modest weight loss.

  5. Regarding safety and patient outcomes, page 41 of the report is especially damning. At least the FDA appears to see through the major gaps. Tonks (above) is correct: if I had turned in a research report like this for a course assignment in nursing it would have failed.

    Critical thinking is not an asset in a profit driven system. The social theorist Max Weber warned about the inevitable tragedy associated with increasing bureaucratization and rationalization of society: it may be highly efficient for a long time but at some point it transforms people into “things”. This state of affairs results because (in order to avoid stagnation, to survive, or to grow) people and organizations are compelled to treat human beings liked things. Thus, humans are now commodities, like natural resources, available for use in the production of greater profits…for hospitals, doctors, stock holders, and other corporate interests.

    Much less evidence has been used as the basis for mass murder (umm, shock and awe), and when later it is discovered there were no WMDs or in this case, about the lap band, no uncontaminated studies or research which will justify the safety risks, it will be too late for the victims. However, the pockets of the corporate *winners* will be overflowing with more than enough profits to take on any piddly lawsuits that may result. Decisions are made on the basis of risk assessment, not risk to the individual patients, but risk to the corporate bottom line (when anticipated and planned for lawsuits eventually arise.) Most health care organizations are private or limited liability corporations. Manufacturers know that the safety problems likely to result, which may be attributed to the lap band, can always be *proven* to be based on the patient’s prior co morbid conditions and on their history of overweight/obesity…and in their version, the lap band may have given the patient extra quality years. Blah, blah, blah. I’ve read enough of this sh*t to know how the rhetoric gets manipulated in favor of the side with the most attorneys.

    One lap band blogger, a great *success* story, (easy to find in our blogland) regularly eats about 700 calories a day to maintain her 125 lb. weight. She requests *fills* (more fluid) whenever she starts getting too hungry. I don’t know if she informs the doc exactly how little she actually eats. She also had a previous history of eating disorders, which she reported before surgery (her claim). The way I interpret this, and other similar self reported evidence on banded bloggers who are NOT anonymous: the band may already be used freely to facilitate anorexia/bulimia while doctors collude (and enable).

    Research that relies on self reports to those holding the power (say, the doctors who have the power to increase the fill or withhold it…essentiall the doc who can relieve the hunger or allow to return), or has corporate bias (now who pays for the study?) is not worth the paper on which it is printed.

  6. Forgive me if I already ranted about this here, but I’m still in shock from seeing my cousin’s wife’s lap-band scars at Thanksgiving… She’s about the same BMI as I am, 35 at most! So doctors are already taking liberties w/those “at risk” (BTW, her overall health is excellent so this was purely a vanity decision).

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: