THE LAP BAND WORKS 1800 GET THIN KILLS PEOPLE!
THE LAP BAND WORKS 1800 GET THIN KILLS PEOPLE!
THE LAP BAND WORKS 1800 GET THIN KILLS PEOPLE!
THE LAP BAND WORKS 1800 GET THIN KILLS PEOPLE!
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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?
THE LAP BAND WORKS 1800 GET THIN KILLS PEOPLE!
Al
California,#2General Comment
Mon, April 16, 2012
Before you accuse anyone of being a killer or murdurer, look at the statistics. They have done over 10,000 Lapband surgeries and had only 4 deaths! The other 9996 patients lives were saved and they live much healthier and happier lives.These are high risk surgeries due to patients obesity and health conditions. look at other surgery centers death rate and then you'll change your mind. All the surgeries were performed by licensed specialty surgeons.
BigMaMaJoans
Los Angeles,#3Author of original report
Thu, February 10, 2011
LOS ANGELES (CN) - From CourtHouseNews.com
Top Surgeons, Almont Ambulatory Surgery Center and Beverly Hills Surgery Center caused multiple deaths by botching lap band surgeries on morbidly obese people, a class action claims in Superior Court.
The lead plaintiff, a widower, says the medical offices are run by two brothers with checkered histories, one of whom is on medical probation, and one of whom lost his medical license after California accused him of "dishonesty, unprofessional conduct, [and] failing to disclose criminal convictions."
Lead plaintiff John Faitro claims his late wife, Laura Lee Faitro, "saw and heard defendants' advertisements on TV and as a result, hired and paid defendants, and each of them, to perform a Lap-Band surgical procedure on Laura Lee Faitro."
The Faitros paid $12,220 for the lap-band surgery, about $3,000 of which was covered by insurance, according to the complaint.
Faitro claims that on July 21, 2010, "Ishan Najib Shamaan, M.D., assisted by Au Lee, M.D., performed a Lap-Band laparoscopic surgery on Laura Lee Faitro at Top Surgeon's ambulatory surgical suite located at 7320 Woodlake Avenue, Suite 320, West Hills, California. During her surgery, Dr. Shamaan lacerated the liver of Laura Lee Faitro in three (3) places, and had to call another Top Surgeon doctor, Kevork George Tashjian, M.D., to assist him to complete Laura Lee Faitro's Lap-Band surgical procedure."
None of those doctors, however, are named as defendants.
The defendants are Top Surgeons Inc., Top Surgeons LLC, 1 800 Get Thin LLC, Almont Ambulatory Surgery Center, Beverly Hills Surgery Center, Kambiz Beniamia Omidi, and Dr. Michael Omidi.
Faitro claims Top Surgeons discharged his wife despite her complaints of severe abdominal pain, and that the pain was so intense it forced her to seek help at the Simi Valley Hospital emergency room. She died on July 26 of "multi-organ failure and infarction due to shock, secondary to bleeding and sepsis in the abdominal cavity," according to the complaint.
Faitro claims that in 2009, California accused Dr. Tashijian of "gross negligence arising from surgeries performed on three patients, two of whom died as a result of his gross negligence."
He claims that "despite the fact that the state of California was, at all relevant times, and is attempting to revoke Dr. Tashjian's medical license ... the defendants, and each of them, have failed and continue to fail to disclose these material facts to their clients and patients on whom Dr. Tashjian continues to perform Lap-Band surgeries."
The serious allegations continue.
Faitro claims that Kambiz Beniamia Omidi aka Julian Omidi is president of Top Surgeons Inc., principal of Top Surgeons LLC, president of Almont Ambulatory Surgery, and CEO of the Beverly Hills Surgery Center.
Faitro says that California revoked Omidi's physician and surgeon's license on June 19, 2009, "for dishonesty, unprofessional conduct, failing to disclose criminal convictions, and a 'penchant for dishonesty, to bend his position and shade his statements to suit his needs, without consistent regard for the truth."
The complaint continues: "Despite the fact that his physician and surgeon's certificate has been revoked by the Medical Board of California ... Julian Omidi owns and manages defendants Top Surgeons, Almont Ambulatory Surgery Center, and Beverly Hills Surgery Center, all of which routinely perform Lap Band surgeries."
Defendant Dr. Michael Omidi is chief of staff and director of surgery for Top Surgeons, Almont Ambulatory Surgery Center, and Beverly Hills Surgery Center, according to the complaint. Faitro says, "the state of California revoked Michael Omidi's physician and surgeon's license effective Oct. 3, 2008 for aiding and abetting the unlicensed practice of medicine and for gross negligence in the treatment of three (3) patients, but his license revocation has been stayed for a period of three (3) years of probation. According to the Medical Board of California, Michael Omidi holds no board certification."
Despite their checkered histories, the complaint states, Julian and Michael Omidi advertise themselves as "top rated surgical specialists" and "specially trained, hand-picked board certified surgeons" who provide "a higher level of care" with a "nationally recognized, expert and caring team," who "go beyond the standard of care."
Faitro says the Omidis know that is not the case, that their "representations are false and deceptive and highly likely to deceive consumers," and that the Omidis' claims "go far beyond mere 'puffery.'"
The complaint adds: "On December 7, 2010, the Health Officer for Los Angeles County requested the FDA to investigate the defendants' advertising of their Lap-Band surgeries because the advertising 'inadequately informs consumers of potential risks' and 'fail to provide the relevant warnings, precautions, side effects, and contraindications related to the procedure.'"
The complaint also object to "defendants' use of "fake newspaper headline stating, 'Insurance Reform May Stop PPO Insurance Coverage for the Lap-Band.'" The class claim this ad "conveys a sense of urgency that if the consumer doesn't rush and make an appointment, he or she may lose the chance to get the Lap-Band surgery paid for by their PPO insurance coverage."
Also, the class claims: "Defendants have advertised that their Lap-Band surgeries are 'safe' and a '1-Hour' procedure ... [but] the Lap-Band surgery requires several hours of post-operative recovery in an out-patient setting and is not a simple '1 hour' process as advertised by defendants." Finally, the class claims that "the published morbidity rates for Lap Band surgeries are between 0.02% - 0.05% (or between 2 and 5 deaths per 10,000 patients). However, plaintiffs are aware of at least four (4) patients of the defendants who died within days of undergoing Lap Band surgeries performed by the Defendants. ... Even assuming defendants have performed 5,000 Lap Band surgeries (which is highly doubtful), these four (4) deaths alone exceed the published mortality rates."(Parentheses in complaint.)
Joining Faitro as a class representative are Arturo and Elvia Renteria, for the estate of Ana Renteria.
The class seeks "restitution and disgorgement and damages for unfair competition and false advertising.
They are represented by Alexander Robertson IV of Westlake Village.