Allergan CEO David Pyott said the company will advise surgeons that any… (Mariah Tauger, Los Angeles…)
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.
The Irvine company does not fund the 1-800-GET-THIN ads that were created by a marketing company that directs prospective patients to clinics that perform the weight-loss procedure using Allergan's device. The Lap-Band is a silicone ring that's surgically fitted over part of the stomach to discourage overeating.
Pyott's statements mark the first time the chief executive has publicly questioned the high-profile advertising campaign. 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.
Pyott said Allergan is in the process of producing guidelines to be distributed to surgeons advising them that any advertising should include clear statements about the risk associated with the stomach-banding surgery.
Although the guidelines would not be binding, Pyott said he hoped to prevent the billboard marketing campaign from spreading to other regions of the United States. He did not say when the company would distribute its advertising recommendations.
The weight-loss surgery advertising campaign is conducted by a marketing company called 1-800-GET-THIN. People who call the toll-free number are screened and some eligible patients are referred to facilities that perform the Lap-Band procedure, said Robert Silverman, an attorney who said he represents the marketing company.
"Like Allergan, 1-800-GET-THIN is fully committed to patient safety and full compliance with all legal requirements associated with the marketing of the Lap-Band medical device," Silverman said in an e-mail statement. "All new television, radio and billboard ads already contain specific disclosures that address the risks associated with the Lap-Band procedure.
"1-800-GET-THIN looks forward to receipt of the guidelines being created by Allergan and anticipates that the current risks disclosures will meet or exceed the guideline recommendations of Allergan. 1-800-GET-THIN has never received any complaint from Allergan regarding any advertisement campaign."
Three Southern California patients have died after Lap-Band procedures, according to family members and autopsy reports in Los Angeles and Riverside counties. The most recent was Lawndale resident Tamara Walter, who died in December after Lap-Band surgery at a clinic in Beverly Hills.
Pyott said research has shown that the surgery is safe and effective, with a mortality rate of 1 in 2,000 procedures. But he said he wants to make sure that any advertisements make it clear that any surgery performed under general anesthesia carries risks.
"The Lap-Band requires a medical procedure," said Caroline Van Hove, an Allergan spokeswoman. "It's important that all advertising include risk-benefit information so the patients can make the right choice."
Pyott is not the first person to criticize the advertising campaign. Dr. Jonathan Fielding, director of the L.A. County Department of Public Health, wrote the FDA in December to voice concern about the advertisements, saying they discourage less-intrusive means to lose weight, such as eating less and exercising.
"Misleading advertisements erode the ability of the majority of the public, who are currently either overweight or obese, to fairly consider alternative weight-management options," he said in the letter.
Fielding also expressed concern about Allergan's proposal to allow less-obese people to have the surgery. The proposed change would make 2 million additional people eligible for the Lap-Band in Los Angeles County alone, Fielding said.
Fielding has since said he will no longer participate in the discussion about Lap-Band advertising because he is a shareholder and former executive of Johnson & Johnson, which sells a competing weight-loss device. He said he was unaware that Johnson & Johnson manufactured the device at the time he sent the letter to the FDA.
Allergan received some encouraging news in December when an FDA advisory panel voted 8 to 2 to recommend that the weight requirement be lowered. If the request is granted, a person with high blood pressure who is 5 feet 10 inches would need to weigh at least 209 pounds to qualify for the surgery, down from the current 243 pounds.