Yesterday, we started to examine a lengthy article by Debra Sherman, part of which concerned two bariatric surgeons who ran a clinic under the auspices of New York University, and another doctor who brought them unwelcome publicity. A reader might have wondered, “But what does this have to do with teenagers?” That part is coming up.
Quick review: Dr. Christine Ren and Dr. George Fielding supervised the lap-band surgery department of the Langone Medical Center. For a short time in late 2005 and early 2006, Dr. Neelu Pal worked under their direction. She objected to procedures that seemed unsafe, and warned patients to stay away. After being fired, she sued, charging wrongful termination.
(While that lawsuit was taking shape, Dr. Pal went to work for a different medical center, from which she was also fired. She sued that institution for unlawful retaliation, and won, early in 2013. A few months later, in August, the Langone case finally made it to court, and Dr. Pal lost that one. Of course, neither of those legal outcomes was known back in 2010, when Sherman wrote her extensive piece for Reuters.)
“Special Report: Targeting Teens for Gastric Bands”
Sherman learned that Dr. Pal’s misgivings about the lap-band clinic were shared by the New York State Health Department, which had some kind of investigation underway when she worked there. More importantly, a crucial matter hung in the balance. The appropriateness of laparoscopic gastric band surgery for adolescents was still being evaluated by the Food and Drug Administration. It had been done, but rarely, and was considered “experimental.” The bureaucratic decision would mean the gain—or loss—of millions in potential profits. The reporter’s inquiries revealed that:
[Dr.] Ren was an investigator in an Allergan-sponsored clinical trial studying the use of bands on teens. And the company has an application…seeking approval to market the device to teens as young as 14…Winning regulatory approval for the gastric band in teenagers would allow the companies that make the devices…to target that specific age group.
At the time when Sherman filed her story, Drs. Ren and Fielding were both still on the payroll of the giant pharmaceutical corporation that manufactured the Lap-Band apparatus.
Six months later, Allergan petitioned the FDA to loosen the strict requirements around patients’ body weight, which would expand the potential customer base from 15 million Americans to more like 42 million. They also wanted insertion of their device to be officially declared acceptable for patients as young as 14.
Adolescent patients could already have the surgery with parental consent, but an okay from the FDA would have cleared the way to advertise it specifically for the teenage demographic. Wanting the surgery to remain a last-resort medical option, the government balked at that idea, and reacted hard against the notion of undertaking it merely for cosmetic purposes. Associates of the company thumbed their noses at authority and powered ahead with the cosmetic angle, filling Southern California with 1-800-GET-THIN billboards that skated around medical advertising rules on a technicality.
(More next time…)
Your responses and feedback are welcome!
Source: “Special Report: Targeting Teens for Gastric Bands,” Reuters, 07/26/10
Source: “Allergan seeks bigger market for Lap-Band weight-loss device,” LATimes.com, 01/16/11
Image by Wellness GM