Sent the mail! Good Luck!

To B-Spot..you are right..I should respect Dr. Feller's credentials even though we may disagree....

No disrepect intended Dr. Feller! Sorry!

Falc,

You did all you could, logic, examples. Some here just may be blinded by the light!

falceros...I have posted links to photos. Reread my previous post where I once again ask for you to comment on the others I posted. You still cannot find the photos of the minox only and propecia only trialists. I still may ask in the forums for people to direct us to those that are forum participants, but like what you posted- most are going to be of users using other things as well.

To both you and giants, I asked for the FDA pictures- I didn't get them. The vast majority of those that were posted were using other things as well, such as nizoral. I also pointed out where OTHERS were questioning the pictures etc- there was nothing special about those photos at all. As YODA said: "What's funny is that those photos, for example, if I were to say they are all from Low Level Laser Therapy patients, Dr. Feller and all the other non-believers would find a way to DEBUNK each and every one. LOL..Oh, this guy just grew his hair longer...Oh, this guy had towel dried hair in his before photo...Oh, this guys after photo is a little darker, etc etc....LOL!!!"

Have you guys seen the thread over at Hair Loss Help I'm referring to? It's right here

Jacob,

quote:

You STILL CANNOT FIND the photos of the minox only and propecia only trialists.

That's an obsurd statement. I haven't looked for them nor do I intend to. So the reasdon I CANNOT FIND them is because I'm NOT LOOKING for them .

Regarding patient photos...maybe the majority of the poster's photos use other things as well - but some users did not and there was still a difference. Basically I found all those links after searching for a whopping 5 minutes. If I spent more time, I could have provided 1000+ links for you to critique. I provided about 10 links or so as a courtesy - but I'm not trying hard to prove Propecia and/or minoxodil work.

The question is...why do you need these photos? Are you trying to disprove that finasteride and minoxodil are proven for efficacy? State it clearly...do you believe propecia and/or minoxodil have any benefit to the hair loss sufferer?

And if your intention is to prove laser therapy works by trying to discredit others - it won't work. That's as bad as one political candidate trying to win office by slamming the other. Mudslinging doesn't prove that a candidate is qualified and neither does an attempt to discredit one product bring credit to laser therapy. Evidence of cosmetic improvement with laser therapy alone is all that provides convincing proof.

I read through the hairlosshelp post. Thanks for providing the link.

Nobuzz,

You are correct. The funny thing is I'm not trying to disprove laser therapy. Nor do I have reason to prove that finasteride or minoxodil works. If people are SERIOUSLY questioning the efficacy of Propecia and minoxodil but promoting laser therapy, they've lost all credibility period.

Yoda,

I am happy for you if laser therapy is helping you. I will not sit here and say "liar liar pants on fire". But I'm sorry to say your WORDS will convince very few of it's efficacy overall. Have you been taking progressive pictures of your progress of laser therapy alone?

Try to understand I'm not trying to knock you.

I'm only calling that there should be a DEMAND FOR PROOF before people blindly believe a product works.

IF it DOES work - I'd actually be very happy to hear it. I think it would give additional treatment options to people (especially women since they can't use finasteride).

Cheers,

Falc

P.S.

Let me remind you all that I'm NOT an trying to discredit laser therapy.

I'm simply a hair loss sufferer demanding proof of its efficacy.

I cannot in good conscience recommend a product that I don't have confidence in.

Falc

quote:

Originally posted by falceros:
I'm simply a hair loss sufferer demanding proof of its efficacy.

See "efficacy" is really the operative word here.

Well first of all, do you agree that we must first see scientific proof before we can even begin to look at public proof posted on the forums?

If so, I really want someone to explain these points to me then:

1). The Hairmax lasercomb has obtained 510(k) clearance by the FDA.

2). In order to obtain 510(k) clearance the company MUST submit both safety and EFFICACY data. (You can read about 510k clearance on the web)

3). So the question boils downs to do we trust the FDA's judgement on "efficacy" for the Hairmax lasercomb? If not, should we be analyzing/questioning and reading the fine prints of all FDA products we use?

Again I personally don't own a laser comb since I don't feel it's worth it for me. But I don't think it's fair to call it a "scam" like snake oil. That would imply that the FDA is a fraudulent organization.

.

rp1979,

Good points!

I believe scientific evidence should go hand in hand with public evidence...however I feel that visual proof (what I call public evidence) is more substantial than scientific documentation.

But a TRUE scientific study should be able to provide visual proof.

Anyway...that being said...

I personally don't believe it boils down completely to whether we trust the FDA or not - though certainly this should be PART of our consideration of whether the product works.

But let's talk about FDA...

What does 510(k) clearance really mean?

You submit that they approve for both safety and EFFICACY.

But there is evidence that suggests that 510(k) clearance is only about safety and "substantial equivalence"

You can read more about it here.

Once again, I'm not trying to prove laser therapy doesn't work!

But I won't trust FDA clearance for safety and "substantial equivalence" ALONE.

Hey...perhaps it does work and in a couple years there will be more public evidence that it works.

BUT...

I think that everyone (with the exception of those who have financial interest in laser therapy) will agree that it is well over-marketed and well overpriced by many hair restoration clinics.

Falc

Dr. Feller...

My very first post in this forum has to do with this statement here:

"Why is it that grocery store check out clerks whose hands are exposed to laser light all day do not complain of excess hair growth on the hands or forearms? Why is it that people who work in laser printer factories or laboratories that use lasers all day have not reported unwanted hair growth? The obvious answer is that there is no such phenomenon."

After you've had time to reflect on your post, don't you feel that this is a very logically flawed argument to make? That's just really ridiculous on so many points -such as dosage, types of lasers, the AREA that the lasers are hitting: 1) no one said that lasers grow hair where hair doesn't exist, 2) forearm hairs aren't genetically encoded to grow longer than an inch or so anyway, 3)they don't go dormant, and 4) they certainly aren't going to be re-invigorated when they are healthy in the first place.

I wanted to give you a shot to respond to that. Also, just to point out... referring to Jacob as a "newbie" (maybe to this board, but he probably has more than 5,000 posts combined on other boards) isn't exactly accurate, and implying he is "busted" because he has some sort of pro-laser agenda is WAY WRONG. I know you aren't "Psychic Man" so you had no way of knowing that... I'm just telling you now so you'll know from now on.

-O.M.G.

falceros...you still cannot just comment on the pictures or provide the FDA ones for Propecia or Minoxidil. And go ahead and post the 10,000 others- I'm sure I'll have fun with them as well.

I've already pointed out WHY I'm asking for those photos. Another way of putting it is how I put it at HLH just: "Actually they do have a place in this discussion since no one has provided me all those before/after pictures of the trialists from the FDA approval of those substances. And I mean ALL of them, not just the best(haven't even gotten those). They were approved but that doesn't = major results like you're whining about regarding LLLT."

And btw..Dr. Feller HAS moved the goal posts there. Before it was ANY proof that LLLT works. Now it's "significant results" etc.

This from chrome over at HLH:

And here is an email i received from the FDA themselves regarding the Hairmax laser comb "clearance":

----------------------------------------------------------------------------------------------------

Your interest in contacting the US Food and Drug Administration (FDA)
through your recent e-mail is appreciated.

If you look at the Indications for Use statement in the 510(k) data at
the link, you will see that the HairMax is indeed cleared for promotion
of hair growth in those with male-pattern baldness.

I hope this response proves helpful to you!


Cynthia Benson
Office of Communication, Education
and Radiation Programs
Center for Devices and Radiological Health
U.S. Food and Drug Administration
1-800-638-2041, ext. 109

quote:

Originally posted by Dr. Alan Feller:
Falc,
I believe Jotronic did a great job exposing the disingenuousness of the female photo you linked to. I'll take on the rest.

I checked out the FDA 510k and believe that the omission of proof of efficacy is clear. Furthermore, I saw that they cited 4 studies that were performed BY THEMSELVES. I wonder how much stock the clinicians were given to perform the "studies".
Also, you may notice that the STANDARD by which these clinicians gauged the success of the product is not articulated. My bottom line is that if you need a microscope to claim success, then you don't really have a success at all.

So far, without hype,disingneuousness, and heavy marketing laser hair products wouldn't be given a second glance.

On Dr. Bauman's link to flikr all you see is a hodge-podge of patients who have combinations of hair transplants, propecia, and maybe some "laser treatment". Where are the PURE laser treated patients? Why is the hair in the before photos wet down and then dry in the after photos?

But Dr. Bauman is not the only doctor engaging in this purposful confussion. Hair Max laser comb is even more bold in their photo presentations.

I pulled just the first two patient exapmples right off of hairmax's own website. There is no information giving any detail as to what medications these patients may be on nor does it say how long they used the laser comb IF AT ALL!!!

This says it right here "My bottom line is that if you need a microscope to claim success, then you don't really have a success at all."

This is what the truth holds. cCounting hairs is not success. You will not see the real differnce in the mirror. A total waste of money.

quote:

Originally posted by falceros:
I feel that visual proof (what I call public evidence) is more substantial than scientific documentation.

You think that "public evidence" is more substantial than scientific documentation?

Are you saying that we need "a lot" of people posting pics of themselves before we can come to a conclusion of anything?

I mean should we be weeding through Internet forums looking for pics to see if viagra works?

Sorry I just don't understand that logic, perhaps you can further elaborate.

No one in their right minds would pop a pill without seeing some scientific documentation/evidence *first* verified by the FDA.

Think about it. If there were no scientific documentations in the FIRST place about propecia what would make people take it? Unverified pics on the Internet?!

quote:

Originally posted by falceros:
But there is evidence that suggests that 510(k) clearance is only about safety and "substantial equivalence"

Now, to address your concerns about the validity of the 510(k) clearance. What you posted was accurate but doesn't tell the whole story.

So that people won't use the "substantial equivalence" accusation against them, Hairmax conducted a clinical trial that the FDA accepted here:

Satino JL, Markou M. Hair regrowth and increased hair tensile strength using the HairMax LeserComb for Low-level laser therapy. Int J Cosm Surg and Aesthetic Derm, 2003; 5(2):113-117.

If you go read that, you will see that it was a 6 months clinical trial in 4 US sites where 93% of the paticipants age 30-60 had an increase in the number of terminal hairs by the end of that trial.

The reason why Hairmax didn't go for pre-market approval is because it wasn't worth it for them. Kinda like how dutasteride wasn't worth it for GSK.

So the next question you might ask is where are the trialist pics of those participants in the Hairmax clinical trial? Well, we don't have them and that is what Jacob is trying to articulate....we don't have them for propecia or rogaine either.


.

rp1979,

You can't just take one quote from me and refute it...you are taking it out of context.

I also said "I believe scientific evidence should go hand in hand with public evidence" and "But a TRUE scientific study should be able to provide visual proof."

I never said that scientific evidence was unimportant - in fact, I believe the opposite. Certainly I wouldn't advocate a product without a scientific study proving safety and efficacy. But science without visual proof becomes meaningless!

If you put it all together, I am simply stating that if the science is REAL than visual proof should be available. Wouldn't you agree?

One thing you are missing is that I'm not actually saying that visual proof doesn't exist. I'm only stating that I haven't seen enough evidence!

I have viewed some of the pictures and youtube videos posted on HLH. So far I've seen one person report that they've seen progress with laser therapy but the side by side pictures looked the same to me (honestly).

Then we have the case of the bearded lady. I have not read the entire case yet but from what I understand she was having hair removed with a laser not trying to grow it. So before I can comment on this further I will have to read the documentation.

Is there some validity in all this? Perhaps! Like I said, I'm not an avid unbeliever - but more data will be helpful to all.

Regarding the clinical trials - I am familiar with it and have posted it early on in this thread.

Dr. Feller's response to that was:

"I checked out the FDA 510k and believe that the omission of proof of efficacy is clear. Furthermore, I saw that they cited 4 studies that were performed BY THEMSELVES. I wonder how much stock the clinicians were given to perform the "studies".
Also, you may notice that the STANDARD by which these clinicians gauged the success of the product is not articulated. My bottom line is that if you need a microscope to claim success, then you don't really have a success at all."

I admit that some of the above is speculation however I agree with him that a success should be visual to the naked eye without need for a microscope.

BUT...maybe it does work. As I said, I'm not trying to disprove it. I just need more evidence before I can comfortably recommend it to hair loss sufferers.

quote:

So the next question you might ask is where are the trialist pics of those participants in the Hairmax clinical trial? Well, we don't have them and that is what Jacob is trying to articulate....we don't have them for propecia or rogaine either.

Ah...perhaps Jacob should have just said that!

The problem I have is that there is enough science and visual proof (public evidence) of Propecia and Rogaine working - and even though there is scientific evidence to suggest laser therapy working - there is very LIMITED visual proof.

Jacob,

quote:

If you look at the Indications for Use statement in the 510(k) data at the link, you will see that the HairMax is indeed cleared for promotion of hair growth in those with male-pattern baldness.

This is quite ambiguous wouldn't you agree? What does "cleared" mean? We already know it's CLEARED - but what they didn't answer is what that indicates.

Anyway Gentlemen...

I do appreciate the debate. I think I will bow out for awhile because this could continue on forever.

Anyone else is welcome to share their thoughts.

Best wishes,

Falc

What's amazing is that most of the people posting here calling Low Level Laser Therapy a scam have not even tried it. I understand that you don't wanna have to pay for something you think won't work for you...

However, what amazes me even more is that my offer to give someone a free Laser Comb that I built hasn't had any takers.

I give up.....

Yoda,

quote:

However, what amazes me even more is that my offer to give someone a free Laser Comb that I built hasn't had any takers.

Well the problem is with this offer is - has your "prototype" been tested for safety or "substantial equivalence"? How does your product compare with the lasercomb?

Personally if I was going to try laser therapy - I would go out and buy one on the market that I know has undergone tested rather than use a free one developed by a stranger not knowing the strength or regulation of the lasers. No offense

Falc

I was just trying to reiterate my opinion that scientific proof verified by the FDA should be the first and most important criteria before we can even begin to look at what you referred to as public evidence.

The fact still remains that the FDA ACCEPTED the clinical trial performed by Hairmax. We can question all we want about the validity of that trial but to do so we would be questioning the FDA's acceptance of it.

Like I said earlier, I don't think it's fair to call it a scam like snake oil and I feel comfort in telling peole that if you think lasers work buy one. If not, don't.

.

RP1979,

I question the FDA, remember Vioxx?

quote:

Originally posted by nobuzz4me:
RP1979,

I question the FDA, remember Vioxx?

Reassuring right? Knowing that the maker of Vioxx (Merck) is also the maker of Propecia and Proscar LOL

You bring up a good example though. Yes the FDA is not perfect but it has a very good track record IMO.

But let's not lose sight of why the FDA, a Federal body established indirectly by us as citizens of this great country, is there.....It is there to protect us.

BTW how's your HT coming along? Did you know that your doc, Dr. Vogel trained my HT doc?