This year is shaping up as a gratifying one for Allergan, the big Irvine company known for Botox and breast implants.
The leading manufacturer of gastric bands, which are surgically implanted around the stomach to suppress the appetite of extremely overweight people, the company recently persuaded an advisory panel of the Food and Drug Administration to endorse its product for use by an expanded group of patients.
Then there's the recovering economy, which should help buck up sales of its Lap-Band for "unreimbursed" patients -- that is, those whose operations aren't covered by insurance. The cash-pay market, Allergan executives have said, rises and falls in tandem with the unemployment rate.
All that comes as the company is poised to reap the whirlwind of New Year's resolutions by prospective patients determined to lose weight in 2011.
The important question is whether all of this is good for weight-loss patients. More to the point: Is any of it good for the patients?
The issue arises for two reasons. One is that Allergan is an aggressive marketer of the Lap-Band to consumers, many of whom don't have a clue when it comes to assessing the dangers of what is, after all, major surgery, and who may be unaware of studies suggesting that the Lap-Band may not be the obesity panacea its promoters make it out to be.
Another concern is the high-powered marketing of Lap-Band surgery virtually as a cosmetic procedure. The best example is the 1-800-GET-THIN freeway billboard campaign here in Southern California, sponsored by a firm that has identified itself as "a marketing company" that "provides marketing for the 'Lap Band®' procedure." (That little symbol signifies that "Lap-Band" is an Allergan trademark.)
The ads have drawn fire from Jonathan Fielding, head of the Los Angeles County Department of Public Health. Last month he asked the FDA to investigate the campaign as potentially a "misleading promotion" of Allergan's Lap-Band, a device that comes under the FDA's jurisdiction. Among his complaints was that the billboards overstated the suitability of the surgery and were silent on its risks.
The billboards' sponsors filed a complaint against Fielding with the county. They contend he's got a conflict of interest because he's a former executive and a shareholder of Johnson & Johnson, which competes with Allergan in the gastric band market.
The complaint looks like a smoke screen. Fielding complained chiefly about the marketing of Allergan's product and of weight-loss surgery by 1-800-GET-THIN, which isn't a competitor of Johnson & Johnson's.
Fielding says he wasn't aware when he wrote to the FDA that Johnson & Johnson, where he worked in the 1980s, makes gastric bands. He says that although the county counsel says his J&J connections don't pose a conflict, he'll delegate further communications with the FDA and decisions related to weight-loss devices to members of his staff.
GET-THIN isn't the only outfit touting Lap-Band surgery. TV commercials and other advertising by doctors have been known to blanket markets in Texas, the Midwest and elsewhere, taking advantage of a regulatory gap that allows medical providers to make claims for products that manufacturers like Allergan can't.
Allergan says it has no control over how the Lap-Band is marketed by the doctors to whom it sells the device.
"We can't, as a company, regulate that," Cathy Taylor, Allergan's senior manager for corporate communications, told me. "They're not our ads."
But let's look at Allergan's own marketing. The company is a past master at advertising directly to consumers -- that's one way it turned Botox into a cash cow worth $1.3 billion a year, accounting for about one-third of its net sales in 2009, according to the company's regulatory filings.
Compared with Botox, the Lap-Band is a piker, with net sales in 2009 of less than $258 million. But the marketing campaign is turned up full blast. Using social media such as Twitter and Facebook, Allergan has been trying to cajole people into signing a petition asking Congress to combat America's "obesity epidemic" by encouraging "weight-loss surgery" (i.e., the Lap-Band). The company has also sponsored TV commercials featuring mournful plus-sized individuals attesting to how weight-loss surgery would change their lives.
This adds up to an effort to commercialize a medical procedure by appealing to an emotionally vulnerable audience. (Allergan's ads mention in passing that "surgery-related fatalities" are a possibility, but you'd need to TiVo the commercial and run it back a few times to absorb the message.)
"This has somehow become the miracle cure for obesity," says Diana Zuckerman, president of the Washington-based National Research Center for Women and Families, who testified against Allergan's FDA application.