This report once again puts a spotlight on a leading health scourge: wrinkles. At least, it seems that wrinkles rank above many other health issues based on how much time network morning shows devote to the subject.
This time the hook is FDA approval of broader use of an injectable product that stimulates collagen production in the face in order to smooth out wrinkles. The substance had been approved for use in people who had lost facial fat due to HIV.
The taped report and in-studio interview did include a number of strong caveats about problems experienced by some patients and the wisdom of waiting until there is broader experience with the product. However, the only dermatologist featured did work funded by the product’s manufacturer and the only patients in the piece gave glowing reviews. Viewers neither heard about special conditions the FDA placed on the manufacturer that requiring larger and longer clinical trials and adverse effect monitoring nor did they get to see or hear from anyone who needed surgical treatment to correct problems caused by the what the field reporter called “latest breakthrough that doesn’t freeze time, it helps you grow some of it back.”
If, indeed, the segment’s advice was “I think you should wait a few years if you’re nervous about it” – then one wonders why this was worth several minutes of network TV air time.
The story says treatments cost about $800 and that three sessions are typically needed, and that follow-up injections are needed after about three years.
Although the story notes that the benefits are temporary the story said the effects last three years (and included only patients who claimed they still felt some benefit after five years), the manufacturer’s web site says the benefits of treatment last only two years. No data were given on what results were seen in what percentage of patients.
In addition to talking about potential harms, the story could have included at least one patient who got a less-than-satisfactory result.
The report noted that some people who got Sculptra injections needed surgery to remove nodules. The studio interview also noted that people prone to keloids should not use the product. The story also pointed out that inflammation is a common side effect.
The in-studio interview points out that a number of FDA-approved products have been removed from the market after wider use revealed harms that were under-appreciated in the pre-approval clinical trials… and that cautious people may want to wait.
But the taped report refers to “years of clinical trials” and years of experience in Europe and in the U.S. (in people with HIV), without ever revealing any of the evidence from all of these years of experience. And it didn’t point out that the trials used to win FDA approval for wider use involved just a few dozen participants. Also, neither the taped report nor the studio segment mentioned that the FDA is requiring the maker of Sculptra to undertake a 5-year post-approval trial involving 863 patients in order to track the occurrence of nodules and inflammation.
This one is a close call. The in-studio interview points out that potential users should consider just how important it is to them to get rid of wrinkles. Wrinkles are not a disease. But comments about putting back “a few of those passing years” (as though wrinkle treatment actually has an effect on aging) send a message that wrinkles are something that often deserves medical intervention. And the lead-in describes the "fight to look younger." A fight?
The taped report featured only a researcher who did studies for the product manufacturer. While the physician interviewed in-studio may not have a financial relationship with the manufacturer (there was no mention of any ties), her background appears to be in gastroenterology, not dermatology; so the presentation failed to include a qualified independent expert to balance the rosy view presented by the expert whose work was funded by the manufacturer.
The in-studio interview emphasized that by staying out of the sun and avoiding smoking, people can delay wrinkles. The story also briefly mentioned collagen injections and Botox, though only the drawbacks of those alternative products were discussed.
The story notes that Sculptra was recently approved for general use, several years after being approved for use in people with HIV who had lost facial fat.
While the taped report and in-studio interview noted that people should be treated only by properly trained and experienced providers, viewers were not told how to find out if a provider has the proper qualifications.
The story notes that this product has been available for several years in Europe and also for people in the US who have facial fat loss due to HIV… so that the news is FDA approval for general cosmetic use.
The story did not appear to rely solely only on a news release.