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.
If the full FDA approves use of the Allergan Lap-Band for patients with milder obesity than the existing target group, that could add 27 million Americans to its customer base.
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.
To support its proposal to the FDA, Allergan included results from what it calls "a prospective five-year study involving 149 obese patients," which it said shows that the Lap-Band is safe and effective for the larger target market it seeks.
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.
And Taylor says the company hasn't determined whether it will continue the study for the full five years. That's important, because evidence has emerged that the Lap-Band becomes less effective and more hazardous to patient health the longer it remains implanted. After several years, some patients start to regain weight and complications multiply.
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?Copyright © 2014, The Baltimore Sun