Controversy comes at a bad time for Lap-Band maker looking to expand market
So many doctors have been trying to lure people to get Lap-Band surgery, with deadly consequences, that the maker of the Lap-Band surgical device, Allergan, has finally been forced to speak up.
Stuart Pfeifer at the Los Angeles Times recently asked Allergan CEO David E.I. Pyott about the sleazy 1-800-GET-THIN campaign:
The chief executive of Lap-Band maker Allergan Inc. said he doesn't support an independently run Southern California billboard marketing campaign that promotes the weight-loss surgery with slogans such as: "Diets fail! The Lap-Band works!"
"That isn't the wording I would use. We put patients' welfare and safety at the top, so I wouldn't support it," David E.I. Pyott said in an interview Wednesday.
Why is Pyott talking about the Lap-Band marketing now? Pfeifer wrote:
His remarks came as the Food and Drug Administration considers Allergan's request to allow the surgery on less-obese patients, a decision that would add millions more Americans to the pool of potential customers.
Potentially 27 million more people.
Vita Reed at the Orange County Business Journal interviewed Pyott recently, too. Reed didn't ask him about the marketing campaigns but did explain what the regulatory change could mean for Allergan.
The Food and Drug Administration now is considering expanding Lap-Band to those with a body mass index of 35, or even 30 for those with complications from diabetes and other conditions. Lap-Band, an adjustable silicon stomach band, now is approved for people who have a body mass index of at least 40, or 35 with other conditions. Some 70% of American adults are considered overweight or obese by body mass standards. If regulators sign off on Allergan's request, Lap-Band could become available to a 5-foot-9-inch man who weighs 203 to 236 pounds, compared with a current minimum weight of 270 pounds at that height.
It's remarkable that Pyott even commented on marketing campaigns. Surgeons are the company's customers, and companies never criticize their customers.
At the same time, Pyott has to know that the bottom-scraping surgeons who resort to this style of marketing also are more likely to push the envelope in other, more dangerous ways. As my colleague Dr. James Barone at Skeptical Scalpel told me, the four patient deaths that have happened in the past two years by doctors affiliated with these marketing campaigns weren't caused by the Lap-Band itself but by two other factors. First, the patients weren't all good candidates for the Lap-Band, for a host of reasons. Second, they did not receive the proper care before, during and after the surgery. The Lap-Bands certainly have their critics, but everybody knows, too, that even the best device can be improperly implanted.
It isn't just the "Diets Fail!" guys in Southern California pushing surgeries as a cure-all. The get-thin-without-risk meme shows up all over the country. Here in Seattle, when I pull up nearly any story about Lap-Bands in Google, a localized ad pops up that says "KIRO7 and NWWLS are giving away surgery. Enter now! www.TheLapband.com."
That kind of marketing clearly does sell people on the surgeries, but the more these surgeries are handled in a cavalier way, the more bad outcomes are going to occur. More people dying or suffering severe complications after Lap-Band surgery is exactly the wrong trend for Pyott while he is seeking FDA approval to expand the market.
The final straw for him may have been a letter written by the LA County Public Health Department in December. The department's director, Dr. Jonathan Fielding, wrote the FDA asking the agency to investigate the advertising campaigns.
"Misleading advertisements erode the ability of the majority of the public, who are currently overweight or obese, to fairly consider alternative weight management options, and for ‘normal' weight individuals to be concerned about behavior that increases risk of weight gain," Dr. Fielding wrote. "Given the harms of medical complications and unrealistic expectations resulting from misleading promotion of this product, I strongly recommend that FDA take the necessary steps to ensure that 1-800-GET-THIN Weight Loss Centers' LAP-BAND promotion does not constitute misbranding of a restricted device"
This isn't the kind of letter that encourages a federal agency to open the door wider for a company's surgical device.
Next: Allergan helps questionable weight loss surgeons go fishing for patients
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