Medicine before marketing
“The commentary provides an accurate and evidence-based assessment of the use of vaginal laser treatments,” Jason Abbott, B Med (Hons), PhD, professor of gynecology at the University of New South Wales, Sydney, told this news organization. “The marketing of this device is a case of putting the cart before the horse. It is essential that strong, scientific, and reproducible studies be available on efficacy and safety before there is a direct-to-consumer marketing approach.”
Clinicians should advise patients when the treatment effect is likely to be minimal or risky, especially when there is a financial incentive to the clinician, he said. “Governments, regulators, and medical societies have a duty of care to the public to make sure that the medicine comes before the marketing. Otherwise, we are no better than snake oil sellers.
“Given the size of studies to date, the improvement in symptoms following treatment may be less than a few percent,” he noted. “That may be acceptable to some women. We don’t know.”
Dr. Abbott’s team is conducting research to define what women would want as a minimal level of improvement, the maximum cost, and the maximum risk from the laser procedure.
“In cancer … the benefit of a new treatment may only be a few percent for survival,” he said. “That may be completely acceptable for some or even many patients. What we cannot do, however, is extrapolate those same expectations to a treatment for a benign condition where quality of life is compromised.”
Echoing Dr. Kelly and Dr. Welk, Dr. Abbott said, “It is important that there be transparency in the clinical communication. Patients should be told that the best scientific studies that are judged based on their quality show there is no benefit to laser treatment for GSM or urinary incontinence.”
Although the medical risks may be low, he added, “financial risk also needs to be discussed. Patients should be encouraged to participate in clinical trials where there is no cost to them to gain the information first, before wholesale uptake of the treatment. … Should patients still wish to undergo the procedure once the risks and an honest account of the evidence is given to them, that of course is their choice.” Dr. Kelly, Dr. Welk, and Dr. Abbott had no commercial funding or relevant financial relationships to report.
A version of this article first appeared on Medscape.com.