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!
Paid advertisements (not an endorsement):
Greetings Dr. Rassman,We’d like to thank you for taking the time to acknowledge the HairMax LaserComb on your Web site. We take this opportunity to respond to some of your comments and attempt to put to rest much of the ongoing debate over the HairMax LaserComb on your site.
In January of 2007, the HairMax LaserComb was Cleared by the FDA for the “Promotion of Hair Growth” in males with certain classes of Androgenetic Alopecia. This Clearance was based, not solely on a predicate device (as you’ve stated in your blog), but also on solid clinical data from our multi-centered double blind sham controlled study which followed all Good Clinical Practices.
For your readers reference, there are two processes for medical device approvals from the FDA, one being PMA (Pre-Market Approval) and the other is a 510K. Since our laser is considered a NSR (Non Significant Risk) device as defined by international laser safety standards, we appealed to the FDA to submit a 510K based on the safety of predicate devices.Our clinical study, device labeling, GMP (Good Manufacturing Practices) and ISO (Quality) accreditation was the basis of receiving the FDA 510k Clearance.
The study took place at 5 sites throughout the United States. We are currently drafting a medical review of the study to be submitted to a peer-reviewed journal. We have every intention of publishing the study and making the full results available for public scrutiny.
Our statistical data, along with macro analyses of trial participants’ before and after images were proven to be medically significant. Our clinical protocol was IRB approved, followed GCP (Good Clinical Practices) and we utilized clinical trial monitors to verify all source data and case report forms. Please understand that we had to prove to the FDA, under the same statistical scrutiny as both Propecia and Minoxidil, that the HairMax was effective in increasing ‘Hair Counts’ in men with Androgenetic Alopecia.
In addition, we have just completed a clinical study for female Androgenetic Alopecia and have filed a new FDA 510K submission for females. We are cautiously optimistic that it will receive Clearance for females suffering from hair loss.
As for statements on your site concerning the difference between FDA approval and FDA clearance, here is the rule of thumb for submissions cleared by the FDA: In general, Drugs are ‘Approved’ for sale, and Medical Devices are ‘Cleared’ for an ‘Indication of Use’.
In your ongoing critique of the HairMax LaserComb, you also compare the technology to that of the laser hood. Here, again, you are not taking in to account the differences between the two devices. Yes, the HairMax LaserComb and the laser hood both use red lasers, but the HairMax uses a patented special array of hair parting teeth which allow for an unobstructed path of the laser to the scalp. We believe this direct laser path to the hair follicle is a critical design feature which makes the HairMax LaserComb standout from the laser hood and provides greater efficacy. Simple reasoning would indicate that an individual’s hair will block some of the laser energy from the laser hood and they would simply not see comparable results because the laser energy would not reach the scalp.
We have conducted an experiment aimed at assessing the delivery of our laser to the scalp with a specific emphasis on the efficacy of the HairMax LaserComb’s patented hair parting teeth. The results showed that 92% of the laser energy emitted from the HairMax is delivered precisely and accurately due simply to the movement of the hair away from the scalp by the hair parting teeth. The efficacy of laser therapy reaching the scalp of non-parted hair amounted to only 9-24%. Obviously this design feature is only valid for someone with hair.
Finally, your critique of the HairMax always seems to point to an alleged lack of clinical data and a clear mechanism of action.
Similar to Rogaine, how the HairMax LaserComb works is debatable and evolving. It is our hypothesis that the HairMax LaserComb, in some way, stimulates the dermal papilla leading to increased cell proliferation of the hair matrix. We believe this process causes increased production of the hair fiber. Supporting this hypothesis are user reports of faster growing hair.
We further hypothesize that the HairMax is an anagen inductor, and support this hypothesis by user reports of increased shedding at the onset of treatment. To us, this indicates an increase in telogen fallout leading to healthier anagen growth.
A few of your prominent colleagues suggest that the HairMax LaserComb may also have some effect on cell apoptosis, but we will not comment further as we know it will spark debate and we do not have any scientific premise to support this theory, yet.
We are about to conduct further research with histologic biopsies to document some of the changes which occur after HairMax LaserComb usage.
Please understand that when we went public with the fact that we were proceeding with clinical trials, naysayers complained that it was just a farce for us to attempt to increase business. Now that we have proven, through our FDA clearance, that clinical trials were conducted, some people still continue to be skeptics..The real issue seems to be that people are not willing to move away from the status quo. Rogaine and Propecia are approved; we are Cleared; all three of us have been proven as effective treatments for Androgenetic Alopecia.
We don’t guarantee that everyone will see results. From our extensive anecdotal experience spanning over 20 years, we have seen that 45% of users see benefits quickly, 45% of users see benefits over time, and 10% of people will see little results. Keep in mind, compliance is a major factor in the realization of benefits. In reality, treatments for any condition are never a sure bet, and we do not contend that our product is a miracle for hair loss sufferers. It does, however, offer well founded hope and quantifiable results, and that’s what we’re about.
To conclude, we have been collaborating with leading hair researchers and clinics across the world. What we’ve found is that the experts who actively use the HairMax LaserComb accept its efficacy; those who do not remain skeptical.
This seems to be the same issue we encounter with non-users of the HairMax LaserComb who are quick to complain that it is ineffective, but are unwilling to give it a chance to work. The HairMax LaserComb has been on the market since 2001, and one of the key factors in marketing a medical device is user experiences. We believe the HairMax LaserComb has one of the highest levels of customer satisfaction of any hair treatments. In addition to positive changes in hair growth, the quality, condition, tensile strength and manageability of the hair is enhanced. We offer a money back guarantee to our direct customers; if the HairMax LaserComb was not an efficacious treatment we would have been in the archives of a ‘hair loss snake oil’ schemes by now. Instead, we have achieved FDA accreditation and gained acceptance from hair experts and have satisfied users worldwide.
We hope that this clears up any misunderstandings you or your readers may have about our medical device.
Sincerely,Lexington International LLC
As an experienced clinical investigator, it is misleading for Lexington to argue that they “had to prove to the FDA, under the same statistical scrutiny as both Propecia and Minoxidil, that the HairMax was effective in increasing ‘Hair Counts’ in men with Androgenetic Alopecia.” The number of studies and the number of patient “exposure” is dramatically less for the LaserComb, although “superiority” over placebo is a common denominator. When the results of this data are published in peer-reveiwed journals (said to be in draft form for later submission), details of this data -sorely missing from Lexington’s web site – can be scrutinized by patients and physicians. One wonders why this data was not submitted for puyblication immediately upon completion of the study or at least submission of the regulatory filing (as is common practice by biopharmaceutical companies).
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?
Dear LexingtonI am not able to comment on the reliability or scientific soundness of your clinical trials. Alas we’ve all been deprived of the opportunity by your rather strange and very atypical decision not to release full details for public scrutiny and for peer review. I’m aware of your promise to now do so, but there’s no reason why this shouldn’t have been done a long time ago.What little we can see just adds further to the skeptisism. Dr Rassman, who your chief medical advisor holds in very high regard for his “professionalism” and “intellectual brilliance”, has disputed your hair counts, claiming to be an expert as he holds the patent for the technology used. Further to this, your before/after photos make a fair comparison difficult, and give the impression (rightly or wrongly) that standard methods have been employed to exaggerate the difference (if any), including hair wetting, combing of hair in different directions to alter the amount of scalp exposed and tilting the head so the hairline appears further forward.In the absence of a peer-review, you use the FDA clearance as an effective equivalent, claiming it to be a process that is little different to the FDA’s PMA Approval. Indeed you claim that you “had to prove to the FDA, under the same statistical scrutiny as both Propecia and Minoxidil,” and proceed to give a very simplistic explanation of the difference in the two processes. But the FDA go to some lengths to make clear that there is a big difference between the two, for example under the DATA REQUIREMENTS FOR 510(k)s section within their K86-3 guidance notes:“While the Center has concluded that it should sometimes require performance testing data in order to confirm that a new device is Substantially Equivalent, the 510(k) review process is not a substitute for premarket approval, and the Center does not attempt to address all of the issues would be answered in a PMA in its review of 510(k)s. Data in a 510(k) should show comparability of a new device to a predicate device, whereas demonstration, in an absolute sense, of a device’s safety and effectiveness, is reserved for PMAs.”So this blows a massive hole in your claims.Most 510(k) applications are not supported by clinical trials. Most are cleared by proving substantial equivalence (same technological characteristics and same intended use) to a preamendments device that itself has not been proven to be effective. So it just doesn’t make sense that because you submitted clinical information, your application suddenly inherited a massive burden of proof that most other applications don’t have. The FDA may largely have taken your trials at face value; because they showed that it is safe for the intended use, it delivers a laser beam to the scalp as claimed, and APPEARS to be a bit effective. This would be in line with their K86-3 guidance notes on clinical trials, and to do anything more involved would not have been in their remit.If you disagree, what level of effectiveness did you have to prove to the FDA? Their definition is “at least as effective” as the predicate, which in your case is 0%.The FDA has supposed safeguards to prevent against this kind of misrepresentation, in particular Sec. 807.97 instructs that a 510k clearance “does not in any way denote official approval of the device”, and that “any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.” Yet you’ve been doing exactly this, and using the word “cleared” instead of “approved” doesn’t mean that you’re complying with this directive. (Creating an “impression” of official approval is misbranding without actually stating “approval”.) You don’t always even use the word “cleared”, and have described it as “FDA accreditation” here.If you have written confirmation from the FDA of the level of efficacy they required you to prove, of the analysis and scrutiny they applied to your trials and even whether you submitted the full version to enable them to do so, then prove it by publishing their correspondence. Otherwise you should not be making such claims as you really don’t know exactly how the FDA scrutinized them.The documentation I’ve seen from the FDA makes reference only to your submission of summary details of the HairMax clinical trials (as is the norm for 510(k) applications), and that your clearance was granted due to the “finding of substantial equivalence to a legally marketed predicate device” (no mention of having been proven to be effective). Oh and it also makes clear that your clearance was granted subject to you complying with Sec. 807.97 “Misbranding by reference to premarket notification”, which forbids you from making “any representation that creates an impression of official approval” by the FDA of HairMax.
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.