Michael Hiltzik: The FDA and the Lap-Band
Is the motto of the Food and Drug Administration "safety last" when it comes to the Lap-Band?
As my Wednesday column reports, the FDA's approval last week of expanded use of Allergan's silicone weight-loss implant came despite considerable evidence that patients' success at weight loss declines and their side-effects multiply the longer the device remains in their body. Since the Lap-Band is designed to remain in the body permanently, that's a problem.
Not for Irvine-based Allergan, of course. The master marketer of medical nostrums--Botox among them--will gain access to millions more patients as a result of the FDA action. And so, too, will the weight loss clinics associated with the 1-800-GET-THIN campaign here in Southern California. As we've reported, four patients have died shortly after undergoing Lap Band surgeries at clinics connected to the ad campaign, according to coroners' reports and lawsuits.
What's driven the surge in Lap-Band business thus far is the idea that it's safer, quicker, and more effective than traditional weight loss operations, such as gastric bypass. Now that's come into question, via studies that found gastric bypasses to be no riskier than the Lap-Band but more effective. Maybe the FDA moved too soon.
The column starts below.
In 1960, a young inspector for the Food and Drug Administration faced down a powerful drug company by rejecting its application to sell a morning-sickness drug in the United States.
The company, Richardson-Merrell, griped about her repeated demands for more safety data. They complained to her superiors, branding her as a nitpicker. But she stood firm.
The drug in question was thalidomide, and worldwide as many as 12,000 children were born with severe birth defects after their mothers used it. In the U.S., where Frances Oldham Kelsey blocked Merrell from distributing the drug except to a few doctors for "experimental" trials, the toll was 17. Thanks to her, the FDA gained a reputation as a vigilant watchdog.
Today's FDA isn't that FDA.
Read the whole column.