Dr Rassman
Thanks for your excellent blog. Much has been written in your blog about the LaserComb, with various degrees of advocates (and distracters). As a physician, I’d like to amplify on a previous blog, which emphasized that detailed data on the benefits of the LaserComb is not available and thus makes it difficult to evaluate its benefit beyond anecdotal experiences. In addition, the manufacturer makes claims likely to be criticized as unsupportable if similar claims were made for a drug and, to me, employs classic marketing techniques designed to give as little information as possible.
The data supplied to the FDA in support of the LaserComb, which is publicly available at FDA.gov (PDF File) is scant for 4 main reasons: (a) approval was based on use as a device rather than a drug, (b) the threshold of evidence was not the usual superiority of controls required of drugs but “equivalence” to “predicate” devices, (c) a single, controlled study involving a small number of patients was conducted (rather than the usual minimum of 3 studies required of drugs), and (d) unlike studies supporting drug approval, detailed data for the LaserComb is not shown on the aforementioned FDA site. Basic information, such as patient entry criteria, number of patients participating, participating centers and investigators, statistical analysis, etc is absent.
When the manufacturers of the LaserComb report their claims in peer-reviewed, scientific journals where the data can be evaluated by the public, it will allow me to better evaluate the risk/benefit is. In addition, claims made by the manufacturer (“greater than 90% user satisfaction reported!”) are the type of marketing statements that are impossible to evaluate without context. The site also speaks to the single study used to approve the device but fails to mention the number of patients used (likely very small), duration of baldness of patients, or what the placebo response is. Photos of successes are also shown on the manufacturer’s site, with no timeframe to let the reader appreciate how long the patient used the device.
Finally, a previous blog noted the 20-week return policy, which gave readers an impression that money will be refunded if the device does not work. This policy, as stated in the manufacturer’s site, is that a partial refund (60%) will be given if the device is returned within 20 weeks. As the site suggests using the device for more than 20 weeks if no growth is seen, (“many of our users report that even in this time frame, with continued use, they slowly start to notice a thickening of their hair, and even show signs of re-growth”), one wonders how many patients with no growth truly send the device in before the 20-week cut-off.
You make many great points and perhaps the manufacturer of the LaserComb (and other manufacturers of similar products) will see your post and address the points you brought up. I know they’ve read this site in the past, as I’ve received correspondence from them when I disputed claims made on their site over a year and a half ago. We’ll see.
Whatever the case may be, thank you for your comments!
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Snippet from the article –
