Critical of the LaserComb’s Claims and FDA’s Rulings
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!â€) 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-growthâ€), 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!
There are a couple of things that I find odd about this study, for one, the study was completed in November of 2005, yet they didn’t submit it to the FDA until September of 2006, I don’t know if submitting a study this long after it has been completed is common practice in clinical research, hopefully someone with experience with clinical investigation can educate me. Also, Lexington states in the above comment that they conducted tests at 5 sites yet their 510k letter and their submitted study state that only 4 test sites were used. The study mentioned the physicians and the total number of test subjects at each site as well as how many were given the comb and how many were given a placebo. Maybe there was a test site or two that Lexington forgot to mention to the FDA?
I have been using a device called the lasercomb(by hairmax) for almost 6 months. Its a product that is supposed to stop hair loss. I used it as indicated in its instructions, 3 times a week and each session not to exceed 10 to 15 minutes. It said to always leave at least 1 day of non use between each treatment which I did. On May 4 2009 I felt dizziness and difficulty to speak and also I felt that I was going to faint. I was rushed to a hospital where I live in Caracas Venezuela, and was addmitted to the emergency room. Upon arrival my blood pressure was very low, 9 over 5 as I recall. All sorts of tests were performed, bllod tests, urine tests, electrocardiogram, cat scan, etc. and all tests were perfectly normal. I described to my doctor that I felt a strange tingling or sensitivity on the top of my skull. When I touched the top of my head I felt an elongated lump on the very top of my skull. I knew that this lump was something new that was definitely not there before. The doctor said he could not conclude if the lasercomb had caused the problem but he recommended me to inmediately stop using it. I did stop using it and the elongated lump on the top of my skull decreased in size each day, and today only 4 days after the episode that sent me to the emergency room its about 80% vanished and I now no longer feel the sensitivity I had been feeling for some time on the top of my skull(which was the spot where I had most intensely focused the use of the lasercomb). I now feel fine but am convinced that the lasrcomb has serious life threatening side effects.