But that study has been underway for only two years -- the patients in the study had Lap-Bands implanted in early 2008. The data submitted to the FDA included complete results only from the first year; of the study's original 149 subjects, six dropped out in the first 24 months, including at least four who had to have their bands removed.
A 2005 Swiss study brought to the FDA's attention by Stephanie Quatinetz, a New York lawyer whose daughter died after a Lap-Band operation, found that "results worsen over time." The Swiss researchers found that more than a fifth of all the studied patients required a "major reoperation," including removal of the band. They concluded that gastric banding "should no longer be considered as the procedure of choice" for extremely obese patients.
It goes without saying that you won't find evidence of long-term drawbacks to the Lap-Band if you focus on data covering one or two years. When I asked Allergan's Taylor about criticism that its recent study was too limited in size or duration to establish the Lap-Band's long-term safety and effectiveness, she replied, "We stand by the data."
Does Allergan stand behind the ads sponsored by doctors and clinics? When L.A. County's Fielding asked the FDA to look into the 1-800-GET-THIN billboards in his Dec. 7 letter, Allergan snapped into action: The company reached out to the FDA, Taylor says, to "discuss how the ads are not Allergan ads -- so there is no confusion on that point."
But shouldn't Allergan be more vigilant about what a "marketing company" like 1-800-GET-THIN says about its product, given the life-threatening potential of the operation? As I've reported, two deaths have been linked by local county coroners to Lap-Band procedures at the Beverly Hills clinic connected to the 1-800-GET-THIN campaign.
It's not as though the GET-THIN billboards are a secret to executives at Allergan's Irvine headquarters. On major Southern California freeways, those billboards are harder to miss than smog.
Allergan does claim to exercise some control over its product: It says it sells Lap-Bands only to surgeons who have completed the company's training program. That program is all of 1-1/2 days in length, followed by a "proctorship" in which the candidate is supposed to observe a trained surgeon perform two operations.
So the company wants to have it both ways. It wants to hawk its product to consumers -- "increase public awareness," as the company describes its marketing goal -- and is apparently happy to profit from its own customers' ad campaigns featuring claims about the product that are devoid of context or qualifications. But when push comes to shove, it also wants to claim the end results are not its responsibility.
Does this sound like ethical corporate behavior? One has to wonder whether Allergan really cares about providing "effective treatment options" for patients facing the serious health consequences of obesity, as it claims to do. Or does it just want to sell lots of Lap-Bands?