Obesity Management: Handguns versus Slingshots?Tuesday, December 7, 2010
Regular readers will be well aware that for most people with severe obesity, bariatric surgery is currently the only therapeutic option shown to reduce both long-term morbidity and mortality.
But this may now change – as yesterday, an advisory panel appointed by the US Food and Drug Administration (FDA), voted 8-2 to extend the currently approved use of the LAP-BAND® System for adults with a BMI of at least 35 or a BMI ≥30 and at least one comorbid condition.
This means that bariatric surgery is about to venture into the area of less-severe obesity, in fact, as a treatment option for people with a BMI as low as 30, provided they have weight-related comorbidities
The Committee’s decision was based, among other considerations, on the results of a 12-month prospective, single-arm, non-randomized, multi-center five-year study involving 149 moderately obese patients, who on average had been obese for 17 years.
In this study, 83.9% of the patients lost at least 30% of their excess weight at the one-year timepoint, more than twice the percentage required for success by the FDA. Remarkably, more than 65% of the patients in the trial were no longer obese after one year.
This degree of weight loss was accompanied by a substantial improvement in dyslipidemia, Type 2 diabetes, and hypertension as well as improvement in Quality of Life (QoL).
During the 12-month study period, the types of Adverse Events (AEs) reported by patients were as expected for the surgical procedure, such as vomiting, dysphagia, and gastroesophageal reflux disease (GERD). Most AEs were mild to moderate in severity and resolved in less than 4 weeks.
Readers may well recall previous posts on the significant impact of adjustable gastric banding in patients with type 2 diabetes but also on the remarkable peri-operative safety of this type of surgery.
Nevertheless, for me as a non-surgeon, this recommendation in favour of bariatric surgery (albeit in this case, specifically for adjustable gastric banding), as a safe and effective treatment for mild to moderate obesity, stands in remarkable contrast to the much tougher stance recently taken by the FDA on pharmacological treatment options for obesity.
Thus, readers will recall that the FDA recently not only took a surprisingly negative view of lorcaserin and qnexa, but also decided to remove sibutramine from the market, based on putative cardiovascular safety concerns seen in high-risk individuals for whom this drug was never intended.
Interestingly, today, the FDA will also hear from an advisory panel on another obesity combination drug (contrave) and I will be curious to see whether or not the advisors find the data on this compound convincing enough for a strong positive vote in its favour.
Although, I certainly agree that gastric banding can provide a useful treatment option for moderate obesity, it is hard to see how the risks inherent in undergoing surgery (even under the safest circumstances) can even begin to compare with the relative safety of taking a pharmacological agent – especially, as in the case of contrave, one that consists of a combination of compounds (i.e. naltrexone SR/bupropion SR), that have been on the market for over 20 years for other indications.
One can only wonder about the curious rationale behind the FDA’s decisions to approve a surgical device for treating mild to moderate obesity, while making it exceedingly difficult, if not impossible, to provide the very same patients with pharmacological options to manage their excess weight.
Interestingly, with the approval of the LAP-BAND for use in patients with a BMI as low as 30, we may now wonder if drug companies will perhaps need to go back to the drawing board and not only prove that their drugs are as effective but also as safe as having your stomach surgically constrained.
Somehow I cannot quite dispel the mental picture of one arm of the FDA happily approving the use of a handgun to go after vermin while another arm of the same agency strictly prohibits the use of a slingshot, because the latter may just be too dangerous to be used for the very same purpose.
Truly interesting times for obesity management.
Disclaimer: I have received consulting and speaking honoraria from Allergan, the makers of the LAP-BAND as well as consulting honoraria from the makers of the pharmaceutical agents mentioned in this post.
Tuesday, December 7, 2010
I just finished reading in detail the NEJM article by Berrintgon et al on Mortaility and elevated BMI. therefore I am impressed that the FDA had the war with all to approve the expanded indication for the Lap-Band system. Now obese people can become more involved early in their own health and get a proven treatment that we know will dramatically cahnge their lives for the good (in addition to living longer and healthier)
I might be bias about the procedure but I have seen what the disease of obesity can do to peoples lives so I am grateful thatthere is an approved and proven procedure soon to be available earlier in the disease process
Tuesday, December 7, 2010
To compare and measure the effect of the surgery, we should have some people go on the post surgery diet without surgery. But I sorta did and lost over 100 pounds. But n=1 does not show anything.
I expect it is all in the head . Test by really through a scare into people; follow this diet or you will die, but before then, you will hurt a lot. But that was my situation. Oh well.
Keep up the fine work.
Wednesday, December 8, 2010
Now that people can have this surgery even though they are not severely ill, I am sure many women and some men too, will want to get it for cosmetic reasons. If you only have one health problem because of your weight, you could probably eliminate that problem through a change in your diet and exercise routines even if you didn’t lose any weight. This is especially true if you are not that large to begin with. However, there are a great many women out there who will do just about anything to be thin, and this type of procedure would be most welcome to them.
Saturday, December 11, 2010
What many fail to realize is that bariatric surgery is no quick fix. If one fails to modify one’s behavior and falls back into the same eating, drinking, and non-exercise patterns held prior to surgery, the surgery is all for naught.
A friend fought for a few years to get her husband’s insurance to pay for a Roux-en-y, as she had HTN, type 2 diabetes, hyperlipidemia, and other comorbidities. She followed the nutritional, exercise, and other behavioral changes for about one year post-op, and did very well. No more HTN, etc. Then she figured she could cheat here, drink carbonated beverages there, and soon she was back on all the previous meds, having regained all the weight she had lost and more.
Disclosure: I am overweight, but am eating healthier and making a concerted effort to exercise. I used to take topiramate for bipolar disorder (one component of qnexa – sure, it can help you lose weight, but it is a scary drug I would personally not recommend to anyone who is not seeing a psychiatrist and receiving therapy) but have been switched to lamotrigine/Li for vastly improved mood stability.
@Jennifer – down here in the States, lapbanding for those without the specified comorbidities would be considered cosmetic surgery, like liposuction, tummy tucks, etc. Ca$h only.
Sunday, December 12, 2010
Arya, I completely agree with your title and comments. I don’t think there is sufficient data to suggest that Lap-Band is safe and effective over the long-term. The company’s study, conducted under ideal circumstances may not be generalizable to the typical clinic situation. There patients will not have access to physicians who are monitoring for band slippage or erosion, as well as free adjustments, or nutritional and/or psychological counseling. Of course Lab Band is effective for some individuals, about 50% do well. But I am not sure that means that all patients who are BMI 30 and above should now be eligible.
Tuesday, December 14, 2010
As a person who has a BMI over 35, but has a heart condition and diabetes, I am not a candidate for surgery of any kind except that which affects the other two. (ie I had my gall bladder out and also had a hysterectomy laparascopically) There is more research showing that our diet recommendations must change. I specifically mean that the “low fat” dogma must be substituted for something that lowers the recommended daily intake of carbs from something like 300 g per day to between 75 and 150g. I also realize n=1 means nothing, but I live with someone who lost 60 lbs following a south beach like diet. His triglycerides are now .83 mmol/L and his total cholesterol is 4.04 mmol/L. His HDL is 1.23 mmol/L. IF we want to help obese people lose weight, and reduce their risk factors at the same time, this course of action is worth investigating. We won’t reduce peoples risk factors if they persist with high triglycerides, low HDL and lots of VLDL sticky particles.