FDA Approves Expanded Use of Lap-Band With Little Review

With much fanfare, the popular <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">Lap-Band device for weight loss was recently approved for expanded use by the U.S. Food and Drug Administration (FDA), despite a lack of safety data. The LA Times also points out that it appears as if the agency did not take into consideration the device maker’s illegal marketing tactics for its blockbuster drug, Botox.

The FDA’s approval of an application by Allergan to broaden its demographic for its Lap-Band weight-loss device was based on just one year of study with 149 participants and only partial information, said the LA Times.

Lap-Band, which has been used by tens of millions, is surgically implanted around the stomach to prompt appetite suppression and is approved for morbidly obese people unable to lose weight with diet and exercises, explained the LA Times. The prior approved standard meant that a five-foot, eight-inch tall person at least 262 pounds—more than 100 pounds overweight (or 230 pounds, at the same height, if diagnosed with an obesity-related condition, such as diabetes) would be eligible for Lap-Band, said the LA Times. Now, the figure of 262 becomes 197 pounds.

Allergan’s past with Botox is noteworthy given the quick approval to broaden Lap-Band’s use, which will likely lead to more intense marketing. This September, Allergan pleaded guilty to one criminal misdemeanor count of “misbranding” Botox and agreed to pay $600 million for fines and penalties over federal charges, said the LA Times.

The charges stem from activities that began in 2003 when Allergan increased the size of its teams to help physicians receive reimbursements for off-label reimbursements two-fold; held workshops teaching doctors offices how to bill for off-label uses; audited physician billing records to help with the reimbursement process; created a Botox Reimbursement Hotline, giving doctors access to free services to better augment its massive off-label Botox program; lobbied government healthcare programs for increased off-label coverage; managed physician workshops and dinners; paid doctors for attendance at “Advisory Boards”; created a so-called “independent neurotoxin education organization,” meant to increase Botox use off-label; and implemented its “CD/HA Initiative,” (cervical dystonia head-ache) said Consumer Affairs previously.

The government feels Allergan conducted business this way due to the decreased potential to earn money on its approved uses, most popularly, cervical dystonia (CD), a neck spasm that afflicts only about 27,000 people in the U.S. Allergan hoped doctors would prescribe Botox for headaches resulting from the rare CD, an Unapproved Botox Use, targeting a significantly broader demographic, said the LA Times.

From 1999 through 2006, Botox’s CD-HA sales grew by a massive 1,407 percent and, by 2007, total Botox sales exceeded $500 million; most—over 70 percent—was for unapproved uses, said the government, wrote the LA Times.

When the FDA reviewed Allergan’s application to broaden Lap-Band marketing, none of Allergan’s prior illegal marketing tactics appeared to be of concern and, although the FDA advisory panel gave initial approval to Allergan’s December application, it had concerns over the device-maker’s supporting data for safety and efficacy, its 149-patient study, and six other studies, said the LA Times. Three of those six studies, by the way, were conducted by researchers with financial ties to the device maker.

“I chastised Allergan for the cherry-picking they had done in the data,” says John Kral, a member of the panel and a surgery professor at the State University of New York, quoted the LA Times. Diana Zuckerman, head of the National Research Center for Women and Families and a longtime critic of the FDA, and others, felt the panel seemed to ignore longer term study results pointing to weight loss results’ declining and side effects increasing, said the LA Times. Also, according to Zuckerman, Allergan’s study excluded those patients with a family history of autoimmune disease, a high-risk group for silicone implants; Lap-Band is a silicone implant.

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