By Alizah Salario
Wednesday, December 8, 2010
Women's health advocates are unhappy about a FDA advisory panel's support last week for increasing the eligibility scope of a weight-reduction implant used by far more women than men. They say the risks are too clear and the data too limited.
(WOMENSENEWS)--Amy Alina isn't happy about a Food and Drug Administration advisory panel's vote last week to recommend that more people be allowed to use Allergan's Lap-Band, a restrictive weight loss implant that is used by four times more women than men.
"The critical point is that this is another example of a company asking for a broadened approval without demonstrating the device is safe for a broader population," said Alina, program director for the National Women's Health Network, a nonprofit advocacy group in Washington, D.C.
If the FDA adopts the committee's recommendation, 27 million adults would become eligible for the elective surgery. The FDA isn't bound to act in accordance with the advisory committee, but it usually does.
Advertisements depicting svelte, bikini-clad women claiming that these gastric bands have saved their lives and helped them fit into a size six are hard to ignore; they send a mixed message to the millions of women who may soon be eligible for the Lap-Band, warned Alina.
On Dec. 3, a FDA advisory panel of obesity experts voted 8-to-1, with one abstention, that the Lap-Band's benefits outweigh the risks for adults with a body mass index (BMI) of 35 or a BMI as low as 30 with one co-morbidity such as diabetes or hypertension.
A Conflict of Interest
Many of the health experts who served on the FDA's 15 person advisory panel--10 of whom were eligible to vote--maintain financial and/or professional relationships with Allergan or other corporations associated with gastric banding. Here are some of the panelists' conflicts of interest:
Dr. Jon C. Gould, associate professor of surgery at the University of Wisconsin School of Medicine and Public Health in Madison, Wis.: He maintains a "financial interest and/or other relationship" with Covidien Corporation, according to an article he wrote for The Journal of Urology titled "Gastric Band Placement for Obesity is Not Associated With Increased Urinary risk of Urolithiasis Compared to Bypass."
Dr. Walter J. Pories, director of the Bariatric Surgery Research Program at the Brody School of Medicine at East Carolina University in Greenville, N.C.: He's an occasional consultant for Covidien Corporation, which has an agreement with Allergan to market the Lap-Band in conjunction with Covidien's single-incision surgery, as well as an agreement with Johnson and Johnson Corporation, which sells the Realize gastric band.
Dr. Steven D. Schwaitzberg, chief of surgery at the Cambridge Health Alliance and associate professor of surgery at Harvard Medical School in Cambridge, Mass.: He is the incoming president of the Society of American Gastrointestinal and Endoscopic Surgeons, a professional organization supported by Allergan.
Dr. Karen L. Woods, gastroenterologist at The Methodist Hospital in Houston, Texas: She owns a significant amount of stock in Allergan, though as chairperson of the panel she was unable to vote.
Dr. Jeffrey L. Zitsman, associate clinical professor of surgery at the College of Physicians and Surgeons at Columbia University and director of the Center for Adolescent Bariatric Surgery at the Morgan Stanley Children's Hospital, both based in New York: He's a member of the Program Committee and the Pediatric Committee of the American Society of Metabolic and Bariatric Surgeons, which receives funding from Allergan.
BMI is a metric based on the relationship between height and weight. It's used to evaluate a person's risk for weight-related health problems.
Under current guidelines, a person with diabetes and a BMI of 35 who is 5 feet 9 inches and 236 pounds is eligible for the Lap-Band. If the lowered BMI threshold is approved, the same person would have to weigh just 203 pounds.
The Lap-Band is an inflatable silicone ring that cinches the top of the stomach and severely limits food intake. The stomach-shrinking device often makes patients feel full more quickly.
Currently, the surgically implanted device is available to adults with a BMI of 40 or higher or those with a BMI of 35 and related health problems.
The committee cited data from the first year of a five-year study sponsored by Lap-Band and Botox manufacturer Allergan, based in Irvine, Calif. The majority of the 149 patients studied were said to have lost 30 percent of their excess weight in the first year post-operation with minimal complications.
Dr. Diana Zukerman, president of the National Research Center for Women and Families, a Washington nonprofit that researches health and safety, joined other health advocates in cautioning the FDA advisory panel against recommending a permanent implant based on a small, short-term study that included very few African Americans, Hispanics or men.
"If this is supposed to be a health product, not a cosmetic product, then you need to look at a solid long-term study," she said. "The FDA should be basing these decisions on scientific research that tells us, 'Will I be better off if I get the product?' That's what we deserve to know, and we can't answer that question."
Several members of the public also shared their Lap-Band experiences with the panel. Two participants in Allergan's study, whose travel expenses to the meeting were paid for by the company, talked about how the Lap-Band had improved their lives.
New York attorney Stephanie Quatinetz, whose 27-year-old daughter Rebecca died in August 2009, two months after undergoing Lap-Band surgery, voiced concern that Allergan's low BMI application, if approved, would lead to an increase in severe complications, including more deaths. Quatinetz presented several long-term studies not funded by Allergan that showed high complication and low efficacy rates.
"When voting, you should consider the health and well-being of thousands of people who are tempted by the illusion that this is a simple, noninvasive, safe and effective product," she said.
Gastric banding, approved by the FDA in 2001, is reversible with another operation and marketed as safer and less invasive than gastric-bypass surgery, a procedure that requires a deep incision into the abdomen and then cutting and reattaching the small intestine to the stomach.
Last year, 22,000 Americans underwent gastric banding, according to the trade group American Society of Metabolic and Bariatric Surgeons, based in Gainesville, Fla.
Several surgeons on the FDA committee noted that women account for approximately 80 percent of their bariatric patients, and a Consumer Reports overview found that 84 percent of all weight-loss surgery patients are women, though women were only 64 percent of those eligible.
Concerns about the safety and efficacy of the Lap-Band arose throughout the meeting.
Dr. John G. Kral, a professor of surgery and medicine at SUNY Downstate Medical Center in Brooklyn, N.Y., abstained from voting on a question about the band's efficacy in the 30-35 BMI population. He and other panelists noted that BMI is a blunt means of measuring the complex relationship between health and weight.
The Lap-Band has been on the international market since 1993 and long-term European studies show an increase in complication and failure rates over time.
Swiss researchers, who published a study in the medical journal Obesity Surgery, found that the complication rate skyrocketed to 74 percent over a 10-year period. Complications include leakage and infection along the Lap-Band, frequent vomiting, dysphagia (an inability to swallow), surgical revision, band erosion and slippage or failure.
A 2007 study funded by Allergan and published in the American Journal of Surgery found that up to 76 percent of patients developed complications over three years. Over a nine-year period, one-third of patients had their Lap-Band removed.
Stomach acid produced from excessive vomiting can erode the band, just one reason for device removal.
While representatives from the company say that surgical improvements have decreased ex-plants, a 2010 Dutch study reveals similar rates to previous studies.
"You've already inherited 1 million [American] patients with a Lap-Band that has a failure rate of 50 percent," said Dr. Edo Aarts, a leading Dutch obesity researcher who cautioned panelists against the expansion.
Aarts followed 201 Lap-Band patients for an average of 10 years and found that weight loss peaked after two years. Only one-third of participants maintained a functioning Lap-Band by the end of the 10-year study.
Aarts also said that in Allergan's study, shedding 30 percent of excess weight was defined as "meaningful" weight loss.
Based on Allergan's criteria, a patient with a BMI of 30 who is approximately 40 pounds overweight must lose just 12 pounds to be considered successful. The advisory panel did not include any experts on diet and exercise as a means of losing weight.
Last month, Allergan recalled 152,000 bands because of a defect in the port, the portion of the device connected to the skin and susceptible to infection. The recall was not mentioned at the FDA advisory meeting.
Allergan is the nation's largest manufacturer of gastric bands and has the majority of the market share. The company's third-quarter earnings for all product sales were $1.192 billion, and its stock was up 3.4 percent to $71 in after-hours trading on the day of the vote.
Not all insurance companies that cover the Lap-Band will pay for a second operation. Many patients end up paying out-of-pocket or have to make an emergency room visit to get the device removed. Aarts warned that a dramatic increase in the number of patients needing surgical revisions could put a tremendous burden on the health care system.
"You are really creating a very big problem for the future," he said.
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Alizah Salario is a freelance journalist based in Chicago. Her work has appeared in The Daily Beast, Ms. Magazine and elsewhere. You can follow her on Twitter at http://twitter.com/Alirosa.
National Women's Health Network:
National Research Center for Women and Families: