FDA Scolds Genentech For Misleading Boniva Ad
6 CommentsBy Ed Silverman // January 26th, 2011 // 10:40 am
To earlier generations of TV viewers, Sally Field was known as the Flying Nun, but Genentech has succeeded in transforming her into something else - a modern-day marketing symbol as the official Boniva pitchlady. And her cherubic face and down-to-earth demeanor have helped Genentech considerably, since the ads for Boniva - which is approved for preventing osteoporosis in post-menopausal women - have become widely recognized staples in the media.
But Genentech runs the risk of sullying this success with ads that contain misleading info. And that’s what the FDA says it found in one recent print ad featuring Field in the December 12, 2010, issue of Parade magazine. The ad contained this line just under a picture of Sally: “Studies show, after a year on Boniva, 9 out of 10 women stopped and reversed their bone loss” (look here).
The agency, however, says this “misleadingly overstates the efficacy” because the claim is not supported by substantial evidence or substantial clinical experience. How so? The FDA maintains the claim is based on “per-protocol, post-hoc analysis of a secondary efficacy endpoint of the percentage of responders” (which was defined as bone mineral density equal to or above baseline at one year) at various points in the body, including the lumbar spine, the hip and femoral neck.
But the FDA writes in a warning letter that the clinical study that served as the basis for approval was designed to assess the percent change from baseline only in lumbar spine BMD at one year. “Thus, this claim is based on a post-hoc responder analysis that the clinical study was not adequately designed to evaluate.” In other words, someone played a little fast and loose.
The FDA notes that Genentech is already taking steps to halt the ad. And most likely, few people spotted the discrepancy. One would have to know a good deal about clinical trials and bone mineral density. But rack up a few more violations of this sort and Genentech will have diluted the value offered by the effervescent Fields. After all, who wants to believe a misleading ad campaign? At that point, Fields wouldn’t be confused with a nun, of any sort. And her career with Genentech would effectively be grounded.
For Real
The FDA is doing a very poor job and it reflects in its attitude and direction. Lest we not mention very poor stewardship. They turnover help like one changes socks. That reflects a lack of true interest apparently due to the poor foundation.
SFM
Those Sally Field ads have always creeped me out.
EddieVos
“strong healthy bones” says Sally or “I tried to keep my bones strong [sic], but it was not enough”. The damn thing is that for hip, having x-ray opaque dense bone [inhibiting the osteoclasts the -dronates so effectively do] may not be a benefit. Infants with low bone density do not break hips, they bend bone. 80% of the reduced spinal fractures, the -dronate success, are asymptomatic spinal compressions measured on x-ray film.
The Aug. 2006 Boniva PI is kind of mum about this but reports “non-vertebral” fractures including hip on placebo 8.2% but on Boniva 9.1%. Agree, the confidence intervals overlap but that is no success!
The FDA does not require, it seems, a public retraction of this misleading ad. The words strong and healthy are misleading in this context.
Peanut
Agree with SFM. Since Sally already looks skeletal in the ads, it she appears to need as much density as she can manage. “Brittle” comes to mind. Scary brittle.
Confession
Part of me always hoped she’d fall off the dock and be eaten by a muskie.
confused
Having women so scare to take hormone replacement therapy because of the miss leading report in 2002 has now opened up a whole new market for making money. If a women replaces hormones with Estradiol she will never need Boniva or anything like that. Estradiol is very cheap and nobody would be making money. The FDA will never tell you this.There has to be something very wrong with this agency.