Allergan Inc. (AGN) won’t seek U.S. clearance to sell its popular Lap-Band stomach shrinking device to an increasing population of obese teenagers.

In the wake of congressional criticism and lawsuits, the Irvine, California-based company has decided to shelve any plans for marketing its Lap-Band device to adolescents, among the fastest-growing group of obese Americans.

Health advocacy groups have warned about the surgery’s safety and its effect on a young person’s developing body. And a 2011 Archives of Surgery study found that almost half of adult patients who had gastric banding had the device removed following infections and other complications.

“These products are marketed as the surgery that can save your life,” Amy Allina, program director of the National Women’s Health Network, a Washington-based advocacy group, said in an interview. “People are being misled.”

About one-third of 200,000 weight-loss surgeries in the U.S. annually use gastric banding, wrapping the small rubber devices around the upper stomach to limit capacity. It costs less than surgery that alters or staples parts of the stomach, and is adjustable and reversible.

Use of the Lap-Band device may grow because obesity rates are predicted to increase. More than one-third of U.S. adults are obese, according to the Centers for Disease Control and Prevention in Atlanta, and medical costs associated with obesity were estimated at $147 billion in 2008 dollars. The adolescent market had been seen as potentially lucrative: the rate of obesity among all U.S. children and adolescents has tripled since 1980 to about 17 percent.

Allergan isn’t elaborating on why it isn’t seeking U.S. permission to market its weight-loss device to a younger patient population. The decision was made at the beginning of the year, Allergan spokeswomen Naziah Lasi-Tejani wrote in an e-mail. The company stands behind the safety and effectiveness of the Lap- Band system it obtained in its 2006 acquisition of Inamed Corp. for about $3.3 billion, Lasi-Tejani said.

“The Lap-Band AP system has an 18-year safety and effectiveness record with more than 650,000 procedures performed to date and adverse events reported in less than two percent of patients,” Lasi-Tejani said in an e-mail.

Patients who undergo gastric banding with Lap-Band can have the rubber device removed entirely if it’s problematic, or have it adjusted using saline infusions to tighten it. The procedure has been popularized by such high-profile patients as Rex Ryan, the New York Jets professional football coach who told the New York Post he lost almost a third of his weight, dropping to 242 pounds.

At the same time, some clinics, hospitals and doctors that offer gastric banding with Lap-Band devices are facing lawsuits over patient care and, in some instances, the tragic outcomes that have followed surgery.

Some Democrats in Congress in January called for hearings on whether the U.S. Food and Drug Administration failed to protect the public from Lap-Band devices. Democrats on the House Energy and Commerce Committee said at the time that Allergan was pursuing the expanded use in children as young as 14 despite concerns by some doctors the procedure is too drastic for a young person’s developing body, according to a Jan. 20 letter to Republican leaders. The adverse public health consequences associated with the device are exacerbated by aggressive marketing, the lawmakers said.

About half of patients who had gastric banding needed to have the device removed, according to a March 21, 2011, study in the Archives of Surgery that found the treatment caused more complications, such as hernias, infection and band slippage, than weight loss. About 1 of 3 had band erosion, which occurs when the band grows into the stomach.

The data is no longer relevant as clinical practices around implantation techniques and follow-up care have significantly improved involving Lap-Band, said Lasi-Tejani of Allergan. Data from about 60,000 patients have shown laproscopic adjustable gastric banding has complication rates that are four times lower than gastric bypass surgery, she said.

Problems have dogged some surgery clinics that provide or market the Lap-Band, including those affiliated with a 1-800- GET-THIN LLC marketing campaign. The use of Lap-Bands by surgical centers associated with 1-800-GET-THIN have been associated with five deaths since 2009, according to the January letter from House Democrats, citing Los Angeles Times stories on fatalities.

The FDA sent a Dec. 12 letter to 1-800-GET-THIN stating their advertising was misleading and failed to reveal the risks of surgery.

1-800-GET-THIN is committed to patient safety and advocacy, and all callers are referred to licensed doctors and accredited facilities that provide disclosure on risks and benefits, according to a press release on their website.

In July, the FDA also told Los Angeles-based Lap-Band VIP in a letter to immediately stop running television ads that leave out information about the procedure’s risks.

Obesity is a measurement of a person’s body mass index, which is calculated using height and weight. A person with a BMI of 30 or more, such as a 6-foot man weighing more than 220 pounds (100 kilograms) is considered obese, according to the National Institutes of Health.

The FDA in February 2011 expanded the use of Allergan’s Lap-Band to include obese individuals with a BMI of 30 to 34 who have an existing medical condition related to their weight. The procedure was approved in 2001 for severely obese patients with a BMI of at least 40; a index of at least 35 and an existing, related condition such as diabetes, or those who are at least 100 pounds (45 kilograms) overweight.

Allergan in 2011 reported about $203 million in net sales worldwide of its obesity intervention products.

“It’s the safest procedure we have,” Jaime Ponce, president of the American Society for Metabolic & Bariatric Surgery, said in an interview. “The procedure itself can have problems, but they get more pronounced if they don’t have the proper follow up.”

Some patient advocacy groups such as the National Women’s Health Network remain skeptical of such assurances, saying deaths and complications raise questions about how well informed patients are before undergoing gastric banding with the Lap- Band.
Almost half of patients undergoing gastric banding for obesity needed to have the device removed, often because of erosion, according to a study that found the treatment caused more complications than weight loss.

About 60 percent of the 82 patients with the device, Allergan Inc.’s Lap-Band, followed over 12 years or more needed additional operations, according to a study by Belgian researchers published online today by the Archives of Surgery. The minimally invasive surgery led to weight loss of 18 percent in 70 patients where data was available.

More than 15 million people in the U.S. are considered severely obese, a total that has almost doubled in the past 25 years. About 220,000 people underwent weight-loss surgery in 2009, up since 2000 when 36,700 operations were performed, according to the American Society for Metabolic and Bariatric Surgery in Gainesville, Florida. Gastric banding represents about one-third of that total.

“I personally no longer perform band gastroplasty, but I think it is defendable for surgeons to continue doing this,” said Jacques Himpens, the study’s lead author who works with the European School of Laparoscopic Surgery at Saint Pierre University Hospital in Brussels. “Patients should not expect too much from the procedure. If they do get the operation, they must commit themselves to lifelong and very tight follow-up.”

Allergan Inc., the world’s largest maker of gastric banding in the U.S., called the study “ill-constructed” in an e-mail. The gastric banding products involved in the study are produced by Allergan, which acquired the product in 2006 with its purchase of Inamed Corp.

The company criticized the study for “severely deficient” follow-up, with data on nearly half of the patients in the 151- patient study never acquired, and a focus on patients that had received their devices “at the very beginning” of the use of gastric bands.

“The surgeons were at the bottom of their learning curve,” said Cathy Taylor, Allergan’s spokeswoman. The Belgian study surveyed patients who had the procedure from January 1994 to December 1997.

Allergan pointed to a study published in 2010 that showed a 12 percent complication rate among 2,909 patients who received the gastric banding in 2001, the year the Food and Drug Administration approved its use in the U.S. The study, conducted by researchers at New York University Langone Medical Center in New York, had received funding from the Irvine, California-based device maker. Allergan controls 73 percent of the U.S. gastric- banding market.
Plastic surgery organizations have drawn criticism from U.S. regulators by trying to downplay the risk of cancer with breast implants, a consumer group said.

The American Society of Plastic Surgeons and the American Society of Aesthetic Plastic Surgery said on their websites that a rare form of cancer tied to Allergan Inc. and Johnson & Johnson (JNJ) implants was benign and could be cured with surgery, the Public Citizen consumer group said today. The Food and Drug Administration talked to the organizations at the request of Public Citizen and the information was removed.

About 60 cases of anaplastic large-cell lymphoma have been reported globally in women with breast implants, including 34 published in studies from January 1997 to May 2010, the FDA said Jan. 26. The agency hasn’t decided on an optimal treatment for these women or what risk factors or prognosis they have.

“While ASPS and ASAPS are independent organizations that the FDA does not regulate, we are committed to assuring that health care providers and patients receive accurate information,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a Feb. 28 letter to Public Citizen.

The plastic surgery organizations say the FDA didn’t require the information to be removed from their websites and that it was replaced with newer information.

“It was never our intention to downplay the risk of a very rarely occurring cancer associated with breast implants,” said Phil Hayes, a spokesman for the American Society of Plastic Surgeons, in an e-mail. “We regret that our word choice caused confusion, and we voluntarily removed the webinar from our website.”

Allergan, of Irvine, California, and the charitable Allergan Foundation each have given at least $25,000 to the American Society of Plastic Surgeons this year, according to the association’s website. The Ethicon, Ethicon Endo-Surgery and Mentor divisions of New Brunswick, New Jersey-based J&J have given at least $25,000 each, according to the website.

Several companies, including Allergan and Mentor, have provided educational grants to the aesthetic plastic surgery organization, said Felmont Eaves, the president of the American Society of Aesthetic Plastic Surgery, in an e-mail. Neither company provided funding for the information removed from the website, he said.

The FDA is urging doctors to report confirmed cases while it works with the plastic-surgeon society and others to develop a registry to track women who receive breast implants.

“As the FDA moves forward with these plans, it is essential that the agency closely monitors the control of the registry to ensure that the integrity of the data being collected is not corrupted by those with significant conflicts of interest,” said Michael Carome, deputy director of health research at Public Citizen. 

Weight-loss surgery, once a last resort for extremely overweight people, may soon become an option for those who are less heavy.  

An advisory committee to the Food and Drug Administration will consider on Friday a request by Allergan, the pharmaceutical company, to significantly lower how obese someone must be to qualify for surgery using the company’s Lap-Band device, which restricts intake to the stomach. On Wednesday, the F.D.A. acknowledged that a new study by the company showed that people in the proposed range of obesity who had the band experienced “statistically significant decreases in all measures of weight loss.”

Drug maker Allergan Inc. has built itself into a multibillion dollar company by going after, and even creating, new markets. Now it’s looking to do that with flagship drug Botox as a treatment for chronic migraine head-aches.

The Food and Drug Administration cleared Botox for migraines last month. According to analysts, the new use eventually could add $1 billion to yearly sales of Botox, which now are $1.3 billion.

The approval is the biggest expansion for Botox since the drug was approved for temporarily removing wrinkles in 2002.

Regulators approved Botox for use in people who have at least 15 headache days per month. Allergan estimates that 3.2 million Americans have chronic migraines. The approval also gives doctors the ability to prescribe Botox for other headache sufferers if they see fit.

The company plans to take data on Botox usage and patients to show insurers “that these people are legitimate and have been appropriately diagnosed,” Chief Executive David Pyott said.

Getting insurers to pay for Botox migraine treatments stands to take time and effort, “but we’ve done that many times before,” Pyott said.

Along with cosmetic use, Botox is approved for treating muscle and neck spasms, eye muscle disorders and excessive underarm sweating.

Only about 10% of the drug’s use now is covered by insurers, according to Marc Goodman, an analyst with UBS AG.

“Management expects a slow ramp due to injector training and limited reimbursement,” he said.

The Food and Drug Administration on Friday approved Botox, the anti-wrinkle shot from Allergan, as a treatment to prevent chronic migraines, a little more than a month after the company agreed to pay $600 million to settle allegations that it had illegally marketed the drug for unapproved uses like headaches for years.

The agency’s decision endorses doctors’ use of Botox to treat patients who suffer from a severe form of migraine involving headaches on at least 15 days a month. Britain’s drug agency approved Botox for the same use this summer.

Botox is already approved by the F.D.A. to treat uncontrolled blinking; crossed eyes; certain neck muscle spasms; excessive underarm sweating; and stiffness associated with muscle spasticity in the elbows and hands. It also is approved for cosmetic purposes — to smooth lines between the eyebrows.

Botox had worldwide sales last year of about $1.3 billion, divided equally between medical and cosmetic uses.

But Allergan said sales of Botox for chronic migraine and other medical uses would soon eclipse sales of the drug as a wrinkle smoother. Allergan is also studying the drug for a variety of new medical uses, including overactive bladder, said Dr. Scott M. Whitcup, the company’s executive vice president for research and development.

In public relations, it’s known as “seeding the market” — stirring up excitement for a forthcoming product or application.

That is the charge leveled against Allergan, the maker of Botox, in a phalanx of false-claims lawsuits and federal inquiries that resulted last week in the company’s agreeing to pay $600 million to resolve criminal and civil complaints of illegal marketing tactics.Allergan also agreed to plead guilty to one misdemeanor charge of misbranding Botox from 2000 through 2005, but the company denied the other allegations.

Allergan’s settlement with the Justice Department resolves the latest crackdown by the federal government against major drug makers. Last year, Pfizer (PFE) and Eli Lilly (LLY) paid hefty sums to resolve federal charges of illegal marketing.

The lengthy federal investigation of Allergan tracked the rise of Botox in an ever-expanding market. Over the last decade, Botox has gained fame — and talk show notoriety — as a wrinkle killer. Along the way, the drug has become a blockbuster brand, with worldwide sales last year of about $1.3 billion, in no small part because it can also be used to treat a variety of muscle and gland disorders.

The Food and Drug Administration has over time approved the injections to mitigate uncontrolled blinking, certain neck muscle spasms, excessive underarm sweating, and wrinkles between the eyebrows. This year, the agency again expanded the use of Botox, permitting injections for increased muscle stiffness in the elbows and hands, and it is now considering whether to approve Botox as a preventive treatment for severe migraines.

Doctors are allowed to prescribe drugs in unapproved ways as they deem medically appropriate, but it is illegal for a drug maker to promote those unapproved, or off-label, uses. Court filings have described an aggressive marketing strategy, saying that Allergan financed and widely disseminated a video, featuring a well-known neurology professor, to promote Botox as a headache treatment; set up an educational Web site called the Neurotoxin Institute, registered by Ogilvy Healthworld, an advertising agency, to promote Botox treatments to doctors; and paid kickbacks to doctors to induce them to prescribe Botox.

“What concerns F.D.A. is that, if companies can promote off-label uses without submitting evidence showing the drug to be safe and effective, it potentially puts patients at risk and subverts the drug approval system,” Dr. Joshua M. Sharfstein, the principal deputy commissioner of the F.D.A., said.

Without an independent determination by agency experts on the optimal doses and precautions for a particular drug treatment, he said, doctors can wind
up prescribing medications without good evidence.

Except for the one misbranding charge, Allergan has denied the criminal and civil accusations, including those of kickbacks and fraud, said Caroline Van Hove, a company spokeswoman, adding that the allegations were not proved.
U.S. regulators seem inclined to approve Allergan Inc's (AGN) wrinkle drug Botox to prevent migraine headaches in millions of Americans, industry analysts said, based on information the drugmaker released on Monday.

Allergan shares rose 6 percent after it said the U.S. Food and Drug Administration requested information on how to safely market Botox for the extremely painful, recurring headaches. It gave details of the request as it reported better-than-expected quarterly results.

"The stock market is thinking that the FDA's request for risk-management information is a precursor to FDA approval" for migraines, said Credit Agricole Securities analyst David Maris.

"The market is excited because it's wondering why would the FDA ask for a program for training physicians if it wasn't going to approve it."

Investors had expected the FDA's decision on Botox by Monday and see the added indication propelling sales of Allergan's biggest product. In Allergan's latest quarter, Botox sales rose 7 percent to $361 million. Analysts believe approval for the condition could boost its annual sales by $500 million or more.

About 18 percent of U.S. women and 6 percent of men have migraine headaches at some time each year, according to the Merck Manual of medical information.

Botox would be meant for the estimated three million Americans who have chronic migraines, meaning 15 or more headache days per month.

Allergan said the FDA will delay its decision for three months after asking the company for an updated Risk Evaluation and Mitigation Strategy on how to safely market Botox for potential anti-migraine use.

Allergan has already provided the FDA with the requested information, including a proposed plan on how to train physicians for the new use of Botox.

"We believe this strongly suggests that (the) FDA will approve Botox for migraine without requesting another study," Wells Fargo analyst Larry Biegelsen said in a research note.

In clinical trials, Botox was given every 12 weeks to prevent migraines, via 31 injections into seven areas of the head and neck.

In one late-stage trial, Botox failed its primary goal of reducing the number of headache episodes compared with a placebo. But it met a secondary goal, as those on Botox had headaches on average 7.8 fewer days each month, compared with a drop of 6.4 days among patients taking placebo.

In a second trial, Botox patients had nine fewer headache days compared with a drop of 6.7 days for the placebo group.

Botox seems to block brain messenger chemicals, called neurotransmitters, that transmit pain, said Dr. David Simpson, a professor of neurology at Mount Sinai Medical Center.

"Current drugs to prevent migraines are far from perfect, so this is a potential significant advance," said Simpson, who has been a consultant for Allergan on unrelated Botox studies. 
Allergan Inc. (AGN) said Friday that the U.K.'s drug regulator became the first in the world to approve Botox, its wrinkle-treatment, as a tool for preventing chronic migraine headaches.

The U.K. approval could shortly precede a decision on migraine treatment from the U.S. Food and Drug Administration. Botox, an injectable neurotoxin, is used for both cosmetic purposes and to treat certain neurological issues. Migraines are viewed as an important new therapeutic market for Irvine, Calif.-based Allergan.

Botox posted sales of about $1.3 billion last year from a mix of cosmetic and therapeutic use. Allergan hasn't precisely estimated when an FDA decision on migraines could come, but has said it sees potential approval this year.

Wells Fargo analyst Larry Biegelsen said he believes the European market alone for chronic migraines could eventually generate $200 million to $300 million in sales, although he said European sales are likely to ramp up more slowly than U.S. sales due to more restrictive reimbursement and less financial incentives for European physicians to administer the drug.

The U.K.'s Medicines and Healthcare products Regulatory Agency licensed the drug as a treatment for preventing headaches in adult patients with chronic migraine following successful clinical trials, Allergan said. The same agency recently ruled that Allergan breached advertising regulations by distributing a survey last year to over 800 British doctors that improperly discussed Botox use for headaches. Allergan issued corrective statements and said the survey was intended to be a legitimate market intelligence-gathering exercise.

Chronic migraines are a debilitating condition in which patients suffer headaches for 15 or more days a month and migraines at least eight. About 700,000 people in the U.K. are thought to suffer from the severe headaches, Allergan said. The company cited data from late-stage studies with 1,384 patients, where those receiving Botox saw a bigger reduction in days with migraines than those who received a placebo, or dummy treatment, at 24 weeks. One of those studies had a main goal of lessening migraine episodes compared with a placebo, and failed on that measure. But it succeeded on the secondary goal of cutting headache days, and Allergan has said the FDA was most interested in that target.