This story highlights the recent approval of a new injected drug that improves the appearance of double chins. The story does note that the treatment can produce a number of potentially serious side effects, which is an important point to mention about a cosmetic procedure. But the deficiencies in the story are significant: it provides few specifics on the benefits of the new drug, fails to provide information about the pivotal studies that led to FDA approval, relies on information garnered from news releases, and seeks no independent perspective on the product. The New York Times’s competing coverage of the same story was better.
Like it or not, lifestyle drugs are big business. So it is not surprising that a “treatment” for double chin has been developed. The FDA approved Kybella based in part on the recommendation of its dermatologic drugs advisory committee. Critical to that approval is a clear understanding on the part of the patient as to the risks and potential benefits of this treatment for a cosmetic condition.
The story says that the company would not discuss the “potential cost” of the drug until after its launch next month, and that the sales of the anti-wrinkle drug Botox exceed $2 billion per year. That’s enough for a Satisfactory rating. The story could have further informed readers by noting that insurers won’t pick up the tab.
Quoting from an FDA press release, the story says that reductions in chin fat were “observed more frequently” in people who got the treatment over those who got a placebo. But exactly what does that mean? How often is “more frequently”? And does a “reduction” mean elimination of the double chin or something less? The findings were based on ratings derived from a clinical examination and a patient assessment. While nearly 70% of Kybella-treated patients saw a one-grade reduction in their double chin fat, compared with 21% in the placebo group, only 13-18% saw a two-grade difference. The two-grade difference means going from marked localized submental fat to minimal (e.g. going from a score of 3 to 1), whereas a one-grade difference would mean going from marked to moderate submental fat, or from moderate to minimal (e.g. score of 3 to 2 or 2 to 1).
To the story’s credit, it makes no mention of the before and after pictures provided in a company news release. These are troubling because the “after” picture shows a woman who is smiling, with lips that appear fuller and skin more heavily made-up than in the “before” picture.
The story notes the FDA’s warning that “the new drug can cause serious side effects, including trouble swallowing or nerve damage to the jaw that can result in an uneven smile or muscle weakness in the face.” It then lists side effects, which included “swelling, bruising, pain, numbness, redness and areas of hardness in the vicinity of the injection.”
This is sufficient for a Satisfactory rating. But the story could have could have mentioned a key concern cited by the FDA in the second sentence of its news release: “Using Kybella for the treatment of fat outside of the submental area is not approved and is not recommended.” A reworded version of that warning is repeated twice more in the news release.
The story does not say how the researchers concluded that the treatment is effective in reducing submental fat, the fat under the chin referred to in pharmaceutical shorthand as SMF.
It provides no detail about the trials on which the FDA based its approval. We know that more than 1,000 people participated in these studies, but little more.
The company’s own submission to the FDA’s advisory committee early this year cites assessments of reductions in SMF from the perspectives of clinicians and patients as well as “objective confirmation of SMF reduction” obtained from measurements made by calipers and by magnetic resonance imaging.
The report adds that “Kythera adopted a 10% change in SMF volume as the threshold for MRI response; this volume change is more closely associated with patients who reported that their SMF was ‘a great deal better’ posttreatment.”
Providing comments such as: “According to a survey last year by the American Society for Dermatologic Surgery, nearly 70 percent of respondents listed ‘excess fat under the chin/neck’ as a key concern about their appearance” suggests that this is indeed an issue for a majority of Americans. The story could have provided more detail about where this number came from — how was the survey conducted and in whom? — but since it provides a link to a report on the findings, readers can theoretically find out more if they want to. So we’ll rate this Satisfactory.
As noted above, we’d prefer it if the story had mentioned the concern — underscored by the FDA in its announcement — that the drug could be prescribed to melt fat elsewhere in the body, which may not be safe.
The story relied almost entirely on a news release and prior comments from representatives of Kythera. It quotes a company official saying the drug “can drive a very large market and leave very satisfied patients.” That seems imbalanced when no independent source is tapped to evaluate the claims.
The story mentions an alternative this way: “… currently patients looking to part with their double chins must have fat removed through more invasive means, such as liposuction.”
We’ll give the story credit for noting an alternative to the 300 injections required with Kybella. But we wish the story had provided information about the comparative effectiveness of the two procedures, or at least a comment that at the moment, no such comparison can be made.
The story notes that the drug will probably not be available before June.
The story is clear about what’s new — a drug that destroys fat cells under the chin.
The story leans heavily on the FDA news release, and the additional context it provides comes from past statements by company stakeholders and a salesy survey about consumer demand for cosmetic procedures. Not quite good enough for a Satisfactory rating.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
Comments (1)
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Desert Horses
May 10, 2015 at 1:34 pmHow does the FDA give “unanimous approval” to something like this while I can’t get an autologous marrow derived stem cell injection for my hip which might save Medicare and my secondary insurer thousands on a surgical hip replacement.
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