Continuing the LaserComb Debate…

Dr. Rassman

It is not my intention to be a “naysayer” or to engage in a continued point-counterpoint debate regarding the Lasercomb. I don’t have any ax to grind. But, in your wonderful site, your readers may not have the background to fully appreciate unusual statements in the Lasercomb response.

As a physician who is an experienced clinical trialist (I negotiated and presented clinical data resulting in drug approvals at the FDA for two major biotechnology companies over a period of 15 years) and a balding patient, the Lexington statement is not entirely forthright for your readers and does not fully address major concerns. It comes across to me as if it’s written by marketing folks rather than scientists involved in analysis and presentation of clinical data. Specifically,

It’s wonderful that “GCP”, “IRB approval”, etc was part of their clinical trial. For your readers, that means that the data was “real” (i.e., not fake or compromised), which of course is important when submitting data to regulatory agencies (FDA). But, the compelling question and real issue is presentation of data and accurate statements. For example,

1. Great that the single pivotal study is being written up for publication. This should have taken 1 week and been done a long time ago. It is highly atypical that a device or drug is approved without the study being published (before approval) in a peer-reviewed, scientific journal. This is truly the only way for physicians and patients to understand the effectiveness and safety profile, and make an educated decision. It is so atypical not to publish such data that the absence creates skepticism, whether deserved or not.
2. It is misleading for those not privy to drug/device approval processes to say that approval was based on the same statistical scrutiny as minoxidil and finasteride. What they mean is that statistical superiority had to be shown over a placebo control. The number of patients used, number of studies conducted, and duration of treatment, follow-up, and extent of the number of patients exposed paled in comparison to the aforementioned drugs. There is nothing wrong with this per se as a medical device should not be held to the same standards as a drug with potential systemic toxicity. But, again, it speaks to the clarity by which the company attempts to educate readers.
3. In the absence of publication of data in a peer-reviewed journal, the company gives only “partial data” on their web site and omits critical information (number of patients in the study, mean compliance, etc) that raises suspicion (even when no suspicion may be warranted). The presentation of clinical data on their web site is so poor that it appears to have been done by those not experienced in how to present data (and thus does not allow readers to be fully educated).
4. LaserComb may be the best thing in the world. The “real issue” is not, as the company states, that “people are not willing to move away from the “status quo.” That is ridiculous. The issue is that, in this age where data is often manipulated, spun, and marketed, companies touting products have an ethical and scientific obligation to provide detailed data of their clinical trials in public forums so that physicians and patients can make informed choices. When such data is not presented (or “in preparation”), a proper evaluation of risk/benefit can not be made, and skepticism abounds. Ironicaly if data is in a form for submission for regulatory approval, a few “cut and pastes” of several sections of the submission document should be all that is required to write up a small study.
5. The Lexington statement notes that “the hair growth, quality, condition, tensile strength, and manageability of hair” is enhanced by their laser. Data???? The company also makes statements based on their “extensive anecdotal experience over 20 years”. While anecdotal experience is not as valuable as placebo-controlled trials, it is still helpful. Let us hope that the company is also writing a manuscript “in preparation” summarizing this experience.
6. One P.S. The company needs to stops saying it “offers a money back guarantee.” As with presentation of their clinical data (so far), a half-truth. The company offers (beyond a month) a 60% refund if the comb is returned within 5 months. Their statement implies that those who find it not effective can return it, which is not the criteria. Again, nothing wrong with their policy. The issue is one of clarity of communication, which is missing for their clinical data.

We appreciate your excellent observations and input into such a controversial subject. I would hope that our readers take the time to reread your comments carefully, for in those comments there are many insights into the research process and when it is credible.

For more from this thread of critical back and forth, see:

• Critical of the LaserComb’s Claims and FDA’s Rulings
• Response from Lexington International (Makers of LaserComb) Regarding Critical Statements

And to read previous posts on the LaserComb, please see the list here.