LLLT and the lack of scientific evidence on either side

[Guest HLBD]

Alright guys, I know that there is a lot of resentment towards LLLT as a treatment on this board and others and my view ??“ although I'm not endorsing or supporting the use of any LLLT product ??“ is equally unpopular simply because I believe, from a scientific standpoint, there is not enough evidence to validate nor dismiss claims of effectiveness and so I refuse to outright condemn LLLT as a treatment until further investigation is done.

 

Quick history lesson: In 1967, shortly after the first working laser was invented, a researcher named Endre Mester with the Semmelweis University of Budapest developed a theory that exposure to cold laser light would, eventually, lead to cancer ??“ he theorized that melanoma (a malignant form of skin cancer) was likely to form from exposure to these cold laser light bands, similarly to exposure to UV radiation emitted by the sun. To test his theory, he shaved a group of mice and trapped some of them in a cage with constant cold laser light exposure and left the other half as a control group. To his surprise, the light didn't cause cancer in any of his animal subjects; however, the mice that were exposed to the laser light grew back their shaved fur much faster than the control group. Mester named his discovery laser or photo (light) biostimulation as he theorized that, somehow, the laser light had stimulated the hair cells into an excited state of growth.

 

Simply knowing this, however, is not enough for us to assume that LLLT would be a satisfactory treatment for MPB. The first problem is that animal studies are notoriously unreliable. Secondly, mice do not suffer from MPB. Finally, just about ANYTHING can make a mouse grow hair.

 

For the validation side of the argument, there are plenty of problems:

 

1. Most of the pictures presented to provide "evidence" are circumstantial (submitted by users of the therapeutic products) and are often taken under different conditions ??“ head positions different from ??before' and ??after' photos, different lighting, different hairstyles or colors, and/or no visible change.

2. The FDA "approval" was not actual approval ??“ the permission to market and clearing of the Hairmax lasercomb was given as conjunction approval based on the device's similarity to other previously cleared devices. Furthermore, though many Internet sites selling LLLT combs and brushes attempt to mislead customers into believing that the FDA approves and cleared all LLLT devices, the FDA does not approve or permit the marketing of any therapy enabled by a device, but the device itself ??“ this is the reason I can't just start making pacemakers and selling them online, saying that ??the FDA approves of electrocardiopulmonary regulation.' The most important factor in approval, marketing permission, or clearing of any medical device, according to the FDA's medical device division is the manufacturing of said devices; the device must follow GMP (good manufacturing procedure: a set of standards established to insure health and safety of the products manufactured).

3. There is no evidence as to how LLLT therapy works, if it does work.

 

On the dismissal side, there are also some issues:

 

1. Most opponents of the LLLT therapy for hair regrowth offer no scientific evidence to back their claims that the devices are ineffective. There is a certain doctor, whom I shall not name, that has mentioned time-and-time again that the devices do not work because they do not concur with "common sense". Speaking as a former member of both high school and college debate teams, this argument won't win any debates. I can't SHOW anyone common sense. I can't point to common sense on a chart and, although I've known many people with sense, I can say with all certainty that it is not a "common" trait ??“ then again, I do a lot of work on the internet these days... True men of science cannot afford the luxury of "common sense".

2. Although most of the information is circumstantial, there is a lot of it and some of it is quite convincing. I recall watching a news segment of a young camera man who agreed on the spot to try an LLLT therapy at a local clinic on which the news agency was reporting and, if there was no trickery involved, the young man's progress was well documented and impressive. He started out maybe a NW 3 and regressed back to a NW 2 or NW 1.

 

The point is that there is not really enough evidence one way or another to determine whether LLLT is an effective treatment for LLLT and most respected proponents only recommend its use in conjunction with other treatments.

 

The debate does put me in mind of a device that once came through our lab for independent validation study. Before I tell you what the device was, perhaps I should tell you that many researchers and assistants did crack some jokes as the device was a "penis stretcher" or penis traction device. No, before anyone asks, I did not try the device personally (I'm pleased with the size of my manhood as it is) and I lucked out by not having to take any... uhem... measurements first-hand (although one of my buddies lost the contest for that).

 

Long story short, the results of our studies did indeed prove that the device did work as its manufacturer claimed (men gained between one and three inches in length over a year period). Its claim was actually scientifically sound as most of the body's tissues are remarkably elastic and do respond to traction. Some of the sites marketing the devices are, however, misleading.

 

The devices work by causing microscopic rips in the tissue at the cellular level. This prompts the cells to divide and heal the breach with more tissue. This will, with time, engorge and enlarge the tissues to which traction is applied. Although most of these sites claim that the procedure is similar to neck stretching that is done by some remote tribes, it is actually closer to ear stretching that has been popular recently in urban cultures.

 

Still, despite our study and numerous others contracted to validate the penis traction device makers' claims and their successful outcomes, many opponents claimed and still state that there is no way the devices could work. Much like the naysayers above, none of these people could provide any reasoning as to why they believed the devices would not work. Also, like the LLLT devices, many among the opponents were and are medical professionals who also have no evidence or logic to support their opinions. In my book, an uninformed and unaware opinion fails by its very nature to be a professional opinion.

[Bill - Seemiller]

HLBD,

 

Very impressive write-up I must say. I also learned something about the laser's history and development as a hair loss treatment.

 

I wholeheartedly agree with most of what you wrote. I thought I'd add a few quick points, some of which is expanded on yours:

 

1. In my opinion, people aren't required to prove that a product doesn't work, only that it does. But I do agree that people who are animate about something and heavily one sided (for or against) should be able to justify their reasons clearly and intelligently, otherwise it's just an opinion based on gut feeling and reaction rather than evidence (general statement). Alternatively however, I don't feel that I have to be able to scientifically prove why pouring chocolate sauce on my head won't make my hair grow. Anyone who tried to convince me that it did without proper evidence, I'd tell them they are being ridiculous. In other words, I believe it's a valid argument to animately argue why something doesn't work using the "lack of compelling evidence" argument.

 

2. There are some respectable physicians who I have talked to that believe that laser therapy can have some marginal benefit for balding men and women, especially as an adjunct treatment (you mentioned this in your article). This is a farcry different from those who market their low level laser therapy device as FDA "Approved" and a cure for baldness. It is marketing here that may be the primary enemy. Taking into consideration these reputable physician claims, perhaps there is more to discuss.

 

3. You make a very valid point about "HOW" laser therapy is supposed to work. Though I haven't done a lot of digging on this yet, has anyone proposed on a chemical or biological level how lasers are supposed to stimulate new hair growth? Or are researchers just accepting that such a phenomenon can exist and attempt to justify it with clinical studies (though none have been released publicly to my knowledge as the one to the FDA was privately released by Lexington themselves)? It would be nice to have an understanding on a chemical or biological level how it is supposed to work.

 

My position is similar to yours. I do not advocate laser therapy as a hair loss treatment, but I'm willing to keep an open mind if enough supportive data becomes public. In the meantime, my primary argument against it is the lack of compelling evidence one.

 

Best wishes,

 

Bill

[MrJobi]

With all of that being said, I still seek a high percentage of real people using it who obtain results. Other than 1 or two , nobody has results other than those trying to endorse it .

 

That's not good enough for me

[Dr. Alan Feller]

HLBD,

 

Nice write up.

But if you were referring to me in your post please don't mischaracterize my position and my approach. We're not in highschool and we're not on debate teams. This is real life and LLLT has not passed the laugh test much less the "common sense" test. Or any other test now that I think of it.

 

No you can't point to "common sense", but so what!? And where did you come up with the charge that I relied on this exclusively?

 

I've pointed to plenty of tangable photos, videos, and interviews produced by the LLLT companies themselves and debunked each and every one with ease. What more tangable evidence does a reasonable person need?

 

I've also debated Dr. Bauman and Mr. Michaels, the CEO of Lexington industires and the so called "inventor" of the laser comb, on the air and embarassed both of them publicly. And they should be embarrased because it was easy to show that neither had any idea of what they were talking about.

 

Have you not noticed that neither Dr. Bauman nor Mr. Michaels has come on to this thread to defend their own position? Of course not, they know they would be trounced. Accountability is the hobgoblin of the snakeoil salesmen. You can bet your last dollar that they both monitor this thread though.

 

You have a doctor out there, Dr. Bauman, who has now been charging thousands of dollars for LLLT for years without a single before/after photo to prove efficacy. Doesn't this shameless soaking of the public bother you? Doesn't such naked and open arrogance disturb you?

 

Who cares what anicdotal animal evidence has been supplied by one or two "scientists". Especially ones in other countries? As far as the mouse "study" in Hungery, for all you know the night janitor was sharing his vodka with the poor mice in the LLLT cage because he felt sorry for them because they were always under red lights and couldn't sleep. Maybe the alcohol increases fur production in rodents. Who knows, and who cares?! The leap you are making from "reports" like those to actual human treatment is preposterous. Dare I say it violates common sense?

 

By all means please prove me and every other anti-LLLT person wrong. And don't do it by attacking us or me personally, give us the evidence that seems to be keeping you in the middle of the road and convince us.

 

I've used my real name and address while putting forth my positions in public. Why don't you do the same?

 

By now there have been tens of thousands of laser units sold. Where the heck are the results? The answer is nowhere because they simply don't exist.

[Cybernaut]

Have you not noticed that neither Dr. Bauman nor Mr. Michaels has come on to this thread to defend their own position?

Lexington has been to Dr. Rassman's blog to defend their position, as recently as March

http://www.baldingblog.com/2008/03/24/response-from-lex...critical-statements/

http://www.baldingblog.com/2008/03/18/critical-of-the-l...ms-and-fdas-rulings/

 

And also back in 2006

http://www.baldingblog.com/2006/08/24/email-response-fr...f-hairmax-lasercomb/

 

Why not post a response to your old comrade Mr. Michaels!

[Dr. Alan Feller]

I haven't been to that blog. I will check it out this weekend and get involved. Thanks for the heads up.

[Bill - Seemiller]

Lexington has emailed me personally in order to defend their position as well. Unfortunately, they weren't able to provide me with any additional information as to what is already public knowledge. So they decided to discuss the FDA clearance (though I believe they used the word "approved" which is incorrect), and the before/after pictures on their website. I'm in the process of writing information for the Hair Loss Learning Center about laser therapy and the presented evidence on both sides.

 

Bill

[HairDew]

I still agree with Dr. Feller - ITS A SCAM.

 

I haven't seen any evidence of ANY PATIENT (Except on the Lexington's website) with clear proof of using ONLY LLLT to promote hair growth. I have seen people saying: "It does work" but those people are also on few other meds or using it after their HT so it is not accurate.

[Dr. Alan Feller]

It's unfortunate that Mr. Michaels chooses to duck the debate by posting his "defense" through Bill. This is very telling of the low confidence he has in himself and his product. If I had to support LLLT I would keep a low profile as well.

[Cybernaut]

Originally posted by Bill:

Lexington has emailed me personally in order to defend their position as well. Unfortunately, they weren't able to provide me with any additional information as to what is already public knowledge. So they decided to discuss the FDA clearance (though I believe they used the word "approved" which is incorrect), and the before/after pictures on their website.

Bill

When did you receive this? Was it subsequent to my thread on the FDA clearance? I would like to see any response to this.

How come you didn't publish it upon receipt as a new thread, in the same way that Dr Rassman has done on his blog? Did they instruct you not to?

[HairDew]

Originally posted by Dr. Alan Feller:

It's unfortunate that Mr. Michaels chooses to duck the debate by posting his "defense" through Bill. This is very telling of the low confidence he has in himself and his product. If I had to support LLLT I would keep a low profile as well.

 

Yup Doc, this is what you get for exposing them

I think they are just AFRAID of you....you are a THORN in their butts

[Dr. Alan Feller]

I'll stop hammering them when they stop soaking the public with their modern day witchcraft and quackary.

[Bill - Seemiller]

Cybernaut,

 

Our conversation wasn't really exciting enough to make public in my opinion.

 

The email was sent to us over 2 months ago and basically asked us why we don't have any information about laser therapy on our Hair Loss Learning Center site. They proceeded by using the FDA "approval" (really clearance) and directed me to their website with their before/after pictures.

 

I responded to them similarly as to how I've addressed all posts here about the topic, that I have not yet seen any real compelling evidence that it indeed works.

 

However, we do intend to be publishing some information on the Hair Loss Learning Center (HLLC) in the near future on LLLT under the "questionable treatment" section.

 

Thanks for your interest.

 

Bill

[Guest HLBD]

Dr. Feller,

 

Is your comprehension of my "write-up" somehow impaired?

 

Look, here's a scientific stance: absence of evidence is not evidence of absence. There is, however, a lack of compelling evidence in this case and so I choose not to support LLLT as an effective treatment for MPB. But the lack of evidence is not a reason to simply off-hand (and rudely, I might add) dismiss anyone ??“ including those that also do not support LLLT ??“ because they don't agree with your tone.

 

If you had understood my stance, I was not at all trying to prove that any LLLT study was effective, hence: Simply knowing this, however, is not enough for us to assume that LLLT would be a satisfactory treatment for MPB. The first problem is that animal studies are notoriously unreliable. Secondly, mice do not suffer from MPB. Finally, just about ANYTHING can make a mouse grow hair.

 

How exactly have you mistaken any of that for support? I don't see anyone else, besides the Feller 'groupies' supporting your often condescending tone, Doctor. If your argument is a 'lack of compelling evidence', then I support it - it's my opinion, in fact. I do not, however, support the childish and irrational way you go about voicing your opinion on the subject. I will not be brow-beaten into submission. Trust me, Doctor, I've been yelled at by many more illustrious and no doubt more intelligent men than you, sir. It doesn't make any difference, reason is reason and you seem to be lacking in that department.

 

I was not, am not, and will not attack anyone personally, Doctor ??“ YOU have made this personal in a very childish manner. I find it a very immature attitude to attack me and accuse me of wrong doing for simply attempting to inform others about LLLT, where it came from and the fact that both sides lack evidence to support whether the devices do or do not work.

 

You wrote to me once: "How do I know it doesn't work? Just use your common sense." How exactly did I mischaracterize your statement, sir? You say that common sense is not your only argument, then show me the data from your studies - oh, that's right, the mighty Dr. Feller doesn't have to have any evidence, everyone else has to show HIM that they're right. Indeed, even if he's present with some potential evidence, he'll simply dismiss it off hand. The only "evidence" you've presented is just as circumstantial as the manufacturers' "proof" of their LLLT devices. It's put-up or shut-up time, Doctor. If you want to prove that LLLT is scam, then PROVE it, with real evidence that can be measured.

 

So what if there are a lot of anti-LLLT posters? What on Earth does that have to do with reason, sir? Just because an opinion is popular doesn't make it right. It's just more circumstantial information.

 

"Have you not noticed that neither Dr. Bauman nor Mr. Michaels has come on to this thread to defend their own position? Of course not, they know they would be trounced." Let me offer this as an alternative as to why these two doctors have chosen not to respond to your petty and irrational provocations: because they're childish and stupid and they degrade everyone involved. Their not going to change your mind and you are going to continue attacking them no matter what.

 

You know what, Doctor, YOUR "naked and open arrogance" disturbs me; which is why I will not communicate (on this forum or elsewhere) with you further. I actually feel very sorry for you, Doctor. I've known many people who would fight tooth-and-nail to be right over the years. If anyone dared think they might not be 100% correct in everything they'd said and done, then those people were ignorant and useless. You know what? None of those people were happy. They were so busy trying to be right all the time that they never chose to simply agree to disagree.

 

Doctor, please grow up.

[Guest HLBD]

Okay, today is a new day. I'll admit, sometimes even my passions get the best of me. My response to you, Dr. Feller, was a bit harsh and I apologize if you felt personally attacked in any of my postings. Please know, however, that I do stand by all of what I said in both posts - I'll not condemn LLLT as a possible therapy for the treatment of MPB without further study and evidence that it is completely ineffective. That does not, by any means mean that I support any of the companies selling these devices and representing as a miracle cure or being misleading in their marketing schemes. I meant only to point out that there is some evidence that it might hold a little value as a possible treatment.

 

I also stand behind my words when I say that I often find your tone to be arrogant and condescending and I now know from both reading other members' correspondence with you and with me privately that I am not alone. I admire your passion, Doctor, but I do not approve of the way in which you voice your opinion or the way you casually dismiss possible evidence instead of examining it objectively. I also stand by my comment that you and other stubborn opponents to LLLT as a possible treatment ALSO lack sufficient evidence to condemn it as a conjunctive treatment with such aggression. Is there reason to be suspicious of LLLT? Absolutely! But there is reason to be suspicious just about everything - in the lab, we used to have a poster of Aristotle with a quote he was remarked to have once said: "I believe all things are possible, but I shall question all things." It's a good message for any person of science to carry with him or her when making decisions as to whether or not something is either plausible or impossible.

 

Now, I'm not at all letting the manufacturers of LLLT devices that misrepresent and outright lie about their products off the hook here. As I stated, they often misrepresent the usefulness of their devices, mischaracterize "endorsements" from doctors and other medical professionals, mislead consumers into believing their devices were found effective in the treatment of MPB by the FDA and other manufacturers that claim that LLLT (not simply one device that was cleared by the FDA) is an effective treatment for MPB. I do not condone their actions any more than I condone opponents to LLLT simply dismissing possible evidence without a complete examination of the facts - I will state, as I have before, that there is simply a lack of evidence (measurable, quantifiable evidence) for or against LLLT. I also do not abide by their selling of the therapy or the devices at outrageous costs. The technology to create these devices has plummeted so much in recent years that most devices only take $25 to $50 (for "comb" devices) and $100 to $500 (for "cap" devices) to manufacture; therefore, selling the plastic, electric lens devices for $500 to $700 dollars or thousands of dollars worth of in-house "therapy" is highway robbery and there are some companies offering both types of devices at a reasonable rate (the problem is that you cannot always be assured of their safety, but with so many things made so cheaply in China, you cannot be assured of the safety of most manufactured goods these days). Then again, the same thing can be said for gasoline ??“ we've always been told that the price of a commodity it determined by the laws of supply and demand, but it doesn't hold against the world's huge stock-pile of oil and weakening demand for gasoline due to the outrageous cost.

 

I will also stand behind my original challenge to you, Dr. Feller: if you want to do the most good here, how about a study of your own (including hair counts and other measurable, quantifiable data) to prove whether LLLT will work at re-growing hair? If your 100% sure you are correct, then it should be no problem. One caveat, though - you'll have to be 100% percent objective and, as a former research assistant, I can tell you that all studies (if they mean to provide definitive proof of their theories) must begin from an opposite stance on the matter; that is that the best way to prove your theory is correct is to attempt to discredit your theory. If you wish to prove that LLLT is a scam and cannot work at all, you must attempt to prove that it DOES work. If you cannot prove that it works, beyond a shadow of a doubt, trying your best, then you have added to the evidence against LLLT. You have asked what more evidence you need to provide? That's it, Doctor.

[Dr. Alan Feller]

HLBD,

I see you may be more passionate about this subject than I. But I think you are wasting your energy having any concern about my attitude and approach. I see and agree we are, for the most part, on the same side.

 

The only problem I have with your basic premise is that you have put the burden of proof on me to disprove a claim. This has never been the scientific way. Doing so falsely puts a crack in the foundation I've been steadily laying against LLLT and this is why I responded sharply to your first post.

 

Need I get on a carpet and jump out of the 2 story window of my office building to prove it doesn't fly? Of course not, the burden is on "flying carpet" advocates to prove magic carpets can fly just as the burdon is on the laser advocates to prove it can grow hair.

 

I am purposefully caustic in my open criticism of lasers and its advocates to create traction for my position. Let's face it, whether lasers do or don't grow hair is really a boring subject when you put it in day to day perspective. A yawn at best.

 

To make the subject more interesting I have moved the foucs to the characters involved. There are villians, good guys, and victims. It's my purpose to make it clear to the readers of this site "who is who" and why. And to keep it light I add humor in the form of extreme absurdity.

 

Also, Mr. Michaels is not a doctor. As far as I know he has no graduate education of any kind. He may not even be a college graduate for all I know.

 

What I do know is that I did debate him and/or his collegues no less than two times on live national radio and his answers were usually evasive and non-sequitor. He knows nothing of the priniciples of science that form the foundation of his "so called" invention and he and his COO demonstrated their gross ignorance in public. Their lack of knowledge base made them a laughing stock.

 

So one has to wonder how such a grossley uneducated duo could have legitamately "created" a product that in essence is the "fountain of youth for hair". It's preposterous.

 

When you speak of arrogance, you should be directing your frustration toward Mr. Michaels and his ilk. It is they who arrogantly take advantage of the public and distort reality to dupe their "customers". It is they who present clearly disingenuous photo results on their website even though they have been proven to be deceptive. And it is they who raise the spirits and then smash the hopes of every hairloss sufferer who is unfortuante enough to find themselves ensnared in their marketing rhetoric.

 

And finally it is THEY who are so arrogant that they feel they are above being accountable and transparent to the public or the customers from whom they've taken millions of dollars by not joining threads like this one. If that is not true arrogance, I don't know what is.

[Cybernaut]

Originally posted by Bill:

They proceeded by using the FDA "approval" (really clearance) and directed me to their website with their before/after pictures.

Bill

Do I take it from what you say that they actually called it an FDA "approval"? That would be interesting to know because it's further proof that they're abusing their clearance.

[HairDew]

Cyber,

 

In their defense they say that the difference between approved and clear is:

 

Drugs are approved and Devices are cleared.

 

Still a SCAM IMHO

[irish homer]

Dr Feller,

I have in my possession a genuine flying carpet, passed down to me from generations long gone. I will gladly pass it on to you in return for 1 free crown HT.

IH

[Dr. Alan Feller]

Does it go supersonic? Because then I could commute to London for consultations and surgery and save you the trip to Great Neck, NY. If it does, then you've got a deal!

 

By the way, I saw your latest post in the photo section. You look great. I'm very happy for you.

[blowdry]

Hey Doc, where is the TOP DOWN SHOT!!!. LOL

[Cybernaut]

Originally posted by Dr. Alan Feller:

I haven't been to that blog. I will check it out this weekend and get involved. Thanks for the heads up.

Dr Feller

Your old friends Lexington have posted again on Rassman's blog

http://www.baldingblog.com/2008/05/02/reader-adds-to-the-lasercomb-fda-debate/

Do leave a response. It should make an interesting read!

[Ducky]

I am new to this site. There is so much negativity in this thread. I don't see any women on here reporting their experiences with the laser treatments either.

 

From what I know: You have to have enough hair to begin with for the lasers to work. If you are already in deep with hair loss, the lasers probably won't be enough.

 

I am very young (23) and have been using the laser therapy for 4 months. I have seen new hairs growing and less shedding.

 

It may not be the best treatment for everyone, but just because it didn't work for you, doesn't mean it's a scam. It's certainly worth a try.

[Dr. Alan Feller]

Pictures Ducky, pictures.

 

This site has a belly full of LLLT advocates who proclaim it's efficacy to one degree or another, but refuse to provide photos to back up their claim.

 

Until you do so yourself, I will consider you to be a LLLT shill who is attempting to spam this board like so many other newbies on here as of the past week.

 

By the way, I caught the cute little fact that you called yourself "ducky" in deference to the QUACK nature of LLLT. A freudian slip in the choice of handles perhaps? Shills are so unimaginative.

[Bill - Seemiller]

Ducky,

 

Do you have any photos to share with us?

 

Though patient testimonies are often taken seriously regarding hair transplant surgery, the efficacy of low level laser therapy is much more controversial. Though as the Associate Publisher of this community, I'm certainly open to both sides of the debate, I highly doubt you'll convince many people without photos.

 

Best wishes,

 

Bill