Posted by Gary Schwitzer in FDA
The following is a cross-post from the Reporting on Health website, written by one of our HealthNewsReview.org story reviewers, William Heisel, who publishes the excellent blog, William Heisel’s Antidote: Investigating Untold Health Stories.
For doctors selling risky cosmetic surgery procedures, using billboards to lure patients is just one more roll of the dice.
This week, the dice rolled snake eyes for the doctors behind the “Diets Fail!” campaign. The U.S. Food & Drug Administration issued warning letters to eight California clinics and a marketing firm telling them that advertisements meant to encourage people to undergo Lap-Band surgery were misleading and needed to be changed.
This is the same group that has been exposed repeatedly by the Los Angeles Times for a series of patient deaths. Antidote started writing about these types of misleading ads in May 2009 after billboards saying “Dieting Sucks!” started popping up around LA.
The FDA sent letters to five people representing nine organizations:
Michael Omidi in Beverly Hills, president of Bakersfield Surgery Institute Inc., Palmdale Ambulatory Center, Valley Surgical Center, Top Surgeons LLC, and Cosmopolitan Plastic & Reconstructive Surgery.
Cindy Omidi, CEO of Valencia Ambulatory Center LLC
Charles Klasky, described in the letter as a “Member” of San Diego Ambulatory Center LLC
Maria Abaca, described as a “Member” of Beverly Hills Surgery Center
One thing to note about this group: never trust a clinic that uses models to stand in for its real staff on its website. Why not put the real people out there, as so many other companies do?
The last group on the list is the company that seems to be the most responsible for the ads promoting cheap Lap-Band surgeries. Every warning letter essentially says that these companies were using 1-800-GET-THIN ads to fool people into thinking that Lap-Band surgeries were low risk. 1-800-GET-THIN has sued Tribune Co., which owns the Los Angeles Times, over its coverage four times. So far, it hasn’t won a dime.
The Times’ Michael Hiltzik and Stuart Pfeifer deserve a ton of credit for sparking the FDA to do something. Another factor in the move by the FDA had to be a letter that Los Angeles County Department of Public Health Director Jonathan E. Fielding sent to the FDA last year. He asked the agency to to investigate the ad campaign. His letter says:
These ads fail to provide the relevant warnings, precautions, side effects, and contraindications related to the procedure. While bariatric surgery is appropriate for certain types of patients, it is not indicated for the vast majority of individuals, and should be reserved for those who have failed other approaches. The LAP-BAND marketing also impairs our ability to effectively implement public health measures by asserting that traditional weight loss interventions ‘fail.’
Every point that Fielding mentions – save for the last one – shows up in the FDA announcement:
In the letters, the FDA warns that billboards and advertising inserts used by recipients of the Warning Letters to promote the Lap-Band procedure fail to provide required risk information, including warnings, precautions, possible side effects and contraindications. The FDA also is concerned that the font size of information related to risks on the advertising inserts is too small to be read by consumers.
“The FDA takes seriously its responsibility to protect consumers from products promoted without adequate warnings,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “It’s particularly troublesome when advertisements don’t communicate the serious risks associated with medical devices.”
So what do these ads look like? For those of you lucky enough not to be bombarded by them while driving around LA, Antidote has created a little slideshow. Don’t miss the most bizarre one of all, which asks people to “Celebrate Black History Month” by getting Lap-Band surgery.
What do you think about these ads? Share in the comments below or send a note to firstname.lastname@example.org. You can also follow Antidote on Twitter @wheisel.
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