An insightful reader sent me this great email below, adding to the ongoing laser hair treatment debate, but also providing some clear bullet points of information that much of the media seemed to miss.

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I’d like to join in the HairMax LaserComb debate, not on whether Lexington’s clinical trials were scientifically sound or whether lazer can regrow hair, but to set the record straight to those who mistakenly believe, or who dishonestly claim, that it was approved by the FDA.

Generally, what exactly does a 510(k) Clearance mean, and what can one reliably infer from it. Some points to consider:

• Minoxidil & Propecia went through a Premarket Approval (PMA) process, where it is necessary to prove efficacy with valid scientific evidence, and is called Approval. HairMax went through a Premarket Notification (510(k)) process which involves demonstrating that the new device is substantially equivalent (SE) to another device already on the market, and is called Clearance.
• Low-risk devices legally marketed prior to May 28 1976 (preamendments devices) with no known safety issues do not require a 510(k) to proceed for market, even though the FDA will have no real idea how effective they are because they’ve never assessed them. (A big clue that the FDA is more concerned about safety than effectiveness for such devices.)
• The vast majority of 510(k) clearances are granted by proving SE to a preamendments device by showing it has the same technological characteristics and intended use. Hence the FDA cannot say with any certainty just how effective the vast majority of cleared devices actually are.
• The FDA do not have a clear definition of the level of effectiveness that would be required; simply that it has to be “at least as effective” as the predicate, which for all the FDA knows could be “not at all” in a large number of cases.
• Clinical trials are very rarely submitted in support of a 510(k) application.
• Even when clinical trials are submitted, the standard 510(k) forms simply require summary information to be provided, whereas submission of the full trials would surely be a mandatory requirement if the FDA always undertake a thorough review.
• No one can be sure of what analysis or scrutiny the FDA apply to such trials, or whether this particular department is even equipped to do so. One thing their website does make clear is that it is not within their remit to ensure that they prove efficacy in the absolute sense as would be required for a PMA, but simply to prove substantial equivalence to a predicate device.
• The FDA will not even confirm whether full details of clinical trials were ever received in support of any 510(k) application, as such information is deemed to be confidential. So the FDA will not confirm whether they could have applied a high level of scrutiny to such trials never mind whether they did.
• The terms under which a 510(k) is granted prevents the device from being advertised or promoted as constituting an official approval or endorsement by the FDA; to do so would represent an abuse that could potentially lead to the clearance being revoked.

Lexington’s application was different to the vast majority as clinical trials were submitted in support. But:

• Anyone who describes or believes the HairMax was approved by the FDA is wrong. It was merely cleared for marketing in the USA.
• By the FDA’s own rules, they see the purpose of clinical data to demonstrate SE to a predicate device, rather than proving efficacy in the absolute sense. In Lexington’s case, their 510(k) application was attempting to prove SE to a device that is not at all effective in hair regrowth.
• There’s no independent evidence that Lexington even submitted the full clinical trials to the FDA.
• There’s no independent evidence that the FDA did little more than take Lexington’s trials at face value; just providing they’d obviously made some attempt to put the device to the test. This doesn’t mean the FDA were negligent, but rather to do anything more involved was simply not within their remit when assessing a 510(k) application.
• Dr. Rassman has already queried the accuracy of the trial’s hair counts on the 2 micro before/after shots.
• The FDA letter granting Lexington clearance makes clear that this was due to “finding of substantial equivalence to a legally marketed predicate device” (as opposed to it having been proven to be effective).

The FDA’s priority is more about safety than effectiveness, and for any 510(k), it should be thought of as simply the FDA giving the manufacturer the go-ahead to proceed to market because it complies with the premarket notification regulations. It should not be assumed that the FDA were satisfied of a high level of efficacy to a high degree of scientific certainty or otherwise.

The FDA do make provision to guard against this kind of misrepresentation, by making the clearance dependent on complying with 21 CFR 807.97 (Misbranding by reference to premarket notification), which prevents the device from being portrayed as any kind official approval or endorsement by the FDA. But this doesn’t mean that a manufacturer can use the 510(k) in order to prove that their device has been scientifically proven to be effective, just providing they use the correct technical term of “cleared”.

And this leads me onto my second point … This has been a massive publicity bonanza for Lexington, with the HairMax reported heavily in the media as “approved” by the FDA and hence scientifically proven. Others have jumped onto the bandwagon, selling all sorts of lazers as FDA approved. This has resulted in a large-scale misrepresentation of what Lexington’s 510(k) actually means or actually proves, and really is quite a disgrace. Lexington will be keen to distance themselves from any responsibility for this misrepresentation, and if the media chose to mis-report or mis-portray it that’s not their doing. They in no way engineered this or even gave it a helping hand, right?

Some examples of media reports are on YouTube. A classic one is ITV’s This Morning. To the initiated 0.0001%, it’s a classic example of how the FDA clearance has been misinterpreted and misrepresented. But who was responsible for actively making this (and other) videos available to the 99.9999% who will inevitably be misled by it? Why it’s the HairMaxTeam!

I agree with other contributors on the blog. What makes me suspicious is why this data was not submitted for publication immediately upon completion of the study or at least submission of the regulatory filing, as is the norm. I welcome Lexington’s assurance to have the studies peer reviewed and published, but why the extraordinary delay? In the mean time, why not make them available in their current form if they’re so confident of their reliability?

Until it has been properly published and peer-reviewed, this remains a single unpublished study, and so no one can legitimately claim that lazer has been scientifically proven to grow hair. The FDA clearance does not change this one iota, and if Lexington - who cannot represent it as being an official approval but have still described it as “FDA accreditation” on this blog - care to claim otherwise, they could be abusing the terms under which it was granted.

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