Tuesday, January 29, 2013

Allergan in the News

Allergan, maker of the Lap-Band® and many other medical devices, made the bariatric headlines on October 30, 2012, when a news article (click here to read it) revealed that they’re considering selling the Lap-Band® part of their business. I don’t have all the details behind the story, but I do have plenty of opinions about it, so I’m sharing those opinions with you in this article.
     The Reuters article said that that Allergan is considering selling the Lap-Band® to another medical device company due to declining sales of the band. Not surprisingly, this news has caused some excitement in the bariatric surgery community.
     I have a hard time drawing any conclusions (pro or con) about the band itself based on the Reuters report. The decline in Lap-Band® sales could be the result of management or other business problems rather than due to a problem with the band itself. It's highly unlikely that Allergan will ever reveal the whole story to anyone but their team of attorneys and board of directors. 
     So, what could this hot news story mean? As you read on, please remember: these are only personal opinions from an ex-bandster who’s fairly well-informed but not a medical professional and in no way associated with Allergan or any other medical device or other company in the world of bariatric surgery. For what it’s worth, here’s my take on the story.
     The US economy is in tough shape, the popularity of bariatric surgery in general is leveling off, and insurance coverage for bariatric surgery is still a challenge. Allergan is not alone in this - Johnson & Johnson must face the same challenge in marketing the Realize™ Band. The story of what's really behind all this is clouded by the reactions of the media and of band-bashers who sing the "I told you so" song because they assume (without any credible basis at this point) that Allergan's decision is related to the safety and/or efficacy of the band.
     All the other bariatric surgery procedures now performed in the USA can have serious complications and failure rates, but it's easier to point the finger of blame at a single manufacturer of a medical device than it is to blame the thousands of surgeons who are doing bariatric procedures that don't happen to use a medical device. The FDA isn't looking over the shoulders of all those surgeons the way it scrutinizes Allergan or Johnson & Johnson. When Dr. John Doe stops doing bariatric surgery and goes back to yanking out gall bladders, no one leads a parade down Main Street waving banners about the dangers of the procedures Dr. Doe was doing. Except in rare cases (such as the sad story of my original surgeon), nobody's even discussing Dr. Doe's surgical expertise or behavior. It's an example of what I call the David & Goliath Syndrome. A big company like Allergan is an easy target thanks to its size and visibility. The general public may step on Dr. Doe's fingers but otherwise will kick him to the curb in eagerness to throw rocks at Allergan.
     One of the hurdles facing any manufacturer of an adjustable gastric band is that it is (in my opinion) the bariatric procedure that requires the most patient education, aftercare, and support. In the 5 years since I was banded, I have encountered plenty of evidence of bariatric clinics doing a great job of that, but I've also encountered clinics that are failing at it, to the detriment of their patients. Not because they're doing something wrong, per se, but because they're directed by a surgeon (or team of surgeons) who was trained to think of surgery of any nature as an in-and-out deal. They're used to seeing the patient 3 times: a pre-op visit; in the operating room (with an unconscious patient); one post-op visit; and never again unless the patient experiences a complication that requires more surgery. That's fine when the surgery involves removing a gall bladder or a mole or a wisdom tooth, but it's a set-up for failure with band patients. The bariatric surgeon who vetted Bandwagon told me several years ago that the band manufacturers make few demands on the surgeons or clinics that buy their products because they don't want to marginalize the customers who don't follow the manufacturer's advice but have acceptable patient outcomes.
     Avoiding marginalization of customers is a smart business decision but a poor medical decision, and I think it's a mistake for us to view surgeons only as super-wealthy, super-powered medical demi-gods anointed by a Supreme Being and the ASMBS. They're also customers, and just like you and me when we're shopping for a new car, they're looking for a product that has reliable quality and performance at a price they can live with. They are business people who want to make money (to pay their staff, their malpractice insurance premiums, their colossal student loans, and their kids' college funds). Sure they want to practice the art (and science) of medicine, but they can't do that very well if they can't pay their bills.
     Finally, keep in mind that someone, somewhere is going to end up with the Lap-Band in some form. It is highly unlikely that Lap-Band® research & development, its technology and FDA approval, to say nothing of the existing customer base, will drop to the bottom of the bariatric pond and never be seen again. Both Allergan and the new owner will legally and ethically have to stand behind their product, with the details of that worked out to the last detail by teams of expensive attorneys and insurance companies. Even surgeons who stop doing band surgery to concentrate on other procedures will still have the basic skill and knowledge to provide fills and other aftercare to their band patients.
     Although I lost my beloved band in April 2012, I do not regret having Lap-Band® surgery and if I were starting my WLS journey today, I would ask my surgeon's opinion about the Allergan decision and also ask how (or if) it will affect his/her practice. The answers to those questions would be towards the top of a long list of questions I'd be asking before deciding to have surgery. And if I still had my band, I'd be asking my surgeon the same questions so that I could go forward with some degree of comfort (if not 100% satisfaction) that I'd have someone to turn to should I need band help in the future. I most certainly would not be rushing off to make an appointment with the Speedy Weight Loss Surgery Revision Center, or at least not until I'd done plenty of homework on the procedures offered by the quacks at Speedy. Trading in a car just because it's 2 years old has never made sense to me, and if it isn’t broke, why fix it?
     Although my journey from Lap-Band® to vertical sleeve gastrectomy ended up taking 6 months, I'm still nagged about it by a little doubting voice, especially when my sleeve is giving me trouble. Should I have chosen the sleeve, or not? Should I have risked the return to morbid obesity, or gamble on more surgery? There are no easy answers to questions like that. If there were a cure for obesity, I'd be first in line for it, but until that cure is invented, I'm making the best of what I've got.

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