Disease-mongering. Failure to evaluate the laughably limited data that were cited. Failure to quantify benefits or harms in a meaningful way. Enough said? If not, read on.
For a column entitled “Aches & Claims,” this entry caused us many aches because it didn’t adequately evaluate claims, such as:
It’s ironic that one week after the big brouhaha over the Supreme Court decision on the Affordable Care Act, a story like this about a cosmetic treatment that costs a minimum of $5,000 – 7,500 never mentioned insurance coverage.
There are many reasons Americans spend a far greater percentage of the GDP on health care than anyone else on the face of the Earth. And stories like this capture just one little slice.
Cosmetic dermatology is one of the few domains in medicine where the “free market” reigns. Although devices such as the laser highlighted in this story are approved by the FDA, the approval process does not guarantee the results. That’s why it is so important to provide readers with as much information about new devices and new approaches as possible.
Costs were discussed. But the story didn’t discuss insurance coverage. One online reader did, though, writing:
“Interesting how while plastic surgery isn’t covered by health insurance, the follow-up care and complications often are. The side effects of this procedure sound horrific, and we all get to pay for it.”
Deep in the story, a company-funded study of 10 (!) women was discussed – resulting in “skin that was 25% thicker after a year.” What does that mean? What is the true benefit of that? The story says doctors graded cellulite reduction as “good to excellent.” In all 10 women? Was this a subjective judgment?
Then the story cites unpublished data from a company-financed trial trial. Might as well have been a news release. Hardly a good source of evidence to cite at this point.
By the end, there really was no good quantification of benefit.
Interestingly, the story provides no information about what the subjects thought about the results.
Potential harms were mentioned:
Cellulaze leaves tiny scars—about two millimeters long—which fade with time, surgeons say. Typically, compression garments are recommended for at least two or three weeks to prevent fluid buildup. And there will be bruises, so patients typically need to wait three to six weeks before venturing out in a bathing suit, surgeons say.
The procedure can cause a buildup of fluid in the area that has been treated, which can last for months and needs to be drained regularly by a doctor.
In a written statement, Cynosure says “a few” patients in early trials had the buildups, called seromas, adding that they need to be drained to prevent infections and other complications. The company says it has since lowered the recommended laser dosage and it isn’t aware of any seromas since the device hit the U.S. market.
But none of these harms was quantified, so the scope of the potential harm wasn’t clear. What does it actually mean when the story uses vague terms such as “typically”…”can cause”…”a few patients” ?
One independent perspective came from a dermatologist who said “”we need more clinical experience before we can make any definitive statements as to the efficacy of the device.”
But the rest of the story was cheerleading in its failure to explain or evaluate the evidence:
Pretty egregious disease-mongering – both in what the story said and it what it didn’t say.
What it said:
Bathing-suit season is here and with it, anxiety over cellulite. A new laser device that burrows under the skin is getting praise from some doctors who say it gives more dramatic and longer-lasting results than previous treatments, but others caution that more research is needed.
Cellulite is a dimpled, uneven appearance of skin caused by fat underneath. It affects some 85% of women and about 5% of men.
What it didn’t say:
Finally, the story described the “battle” with cellulitis, which conjures up images of fat cells being taken on by light sword-armed dermatologists to save humanity from the scourge of dimpled thighs. Battle? Really?
There were two apparently independent sources quoted.
In a practice that is far too common in such stories, this one mentioned alternatives but waved them off as ineffective without citing any data.
Until recently, the main treatments to battle cellulite have been external treatments such as creams and radio-frequency and massage devices. The creams are largely ineffective and the devices have a modest effect that typically lasts about six months, doctors say.
Meantime, this entire story was based on two company-funded studies – one tiny and one unpublished!!!
The story stated that the laser approach “hit the US market in February.”
The story at least mentioned one other “new laser treatment for cellulite and body contouring.” (Although the only data cited on that approach also came from a tiny, unpublished study.)
Because two apparently independent experts were quoted, it does not appear that the story relied solely on a news release.