Looking for some advice on Propecia RE: The cost of it

[MackJames]

I would not bother with anything that has not been through the FDA process. The only home use laser device that is cleared by the FDA for the treatment of hereditary hair loss is the Hairmax laser comb by Lexington International.

Wasn't there some controversy as to the legitimacy of the FDA approval, or more precisely what the FDA approval actually meant in the case of the Laser comb? I vaguely remember hearing something on an old Bald Truth about this subject.

[8868alex]

The Hairmax Lasercomb was "Cleared", not "Approved" by the FDA. According to David Michaels and Randy Veliky of Lexington International, this is because the FDA generally grant clearance to devices and approval to medicines. I use the comb by the way and I would say that it can assist in hair retention.

[Tracy C]

Wasn't there some controversy as to the legitimacy of the FDA approval, or more precisely what the FDA approval actually meant in the case of the Laser comb?

It centers around the difference between "approval" and "clearance". The FDA may "approve" a drug for marketing but they will not "approve" a device for marketing. The FDA may "clear" a device for marketing but they will not "clear" a drug for marketing. See the difference?

Also, many wrongfully believe the FDA "clearance" is for safety only. This is not the case. To obtain FDA "clearance", Lexington had to prove both safety and efficacy.

Since that first FDA clearance back in 2007, Lexington has conducted more studies and submitted more results to the FDA. They have received additional clearances for new models. The FDA really gave Lexington a hard time about clearing the device for treating women’s hair loss. After more studies to prove that the device can treat women’s hair loss, the FDA granted Lexington the clearance to market the 9-laser model to treat women’s hair loss. It is important to note that by that time the safety of the device had already been proven. Lexington had to prove efficacy again - and they did.

There is also the matter of the difference between "statistically significant” improvement and "appreciable” improvement. Just because improvement is "statistically significant", that does not mean the improvement is "appreciable". Again, see the difference?.. Whether the results are appreciable or not depends on how the person using it feels. In my case, with the extensive degree of hair loss I had, "statistically significant” improvement was in fact "appreciable” improvement. Obviously I did not regain a full head of hair - but I did regain enough that everyone noticed it. Everyone commented about it. My feeling on this matter is that if everyone was noticing the improvement, the degree of improvement was appreciable.

Way back when I bought my laser comb, I was unaware of any controversy over it. I simply bought it because my primary care doctor at the time recommended I give it a try. It improved my hair so I have continued to use it ever since. I only became aware of any controversy within the past couple of years. By that time I had already been using my laser comb for a couple of years, so I did not give any weight to any controversy - because I already knew it worked.

At this time, I believe many of those who feel the laser comb is a scam are probably people who are not good candidates for low level laser therapy to begin with. That and/or "statistically significant” results are probably not "appreciable” results to them. Their degree of hair loss may fall outside of what the laser comb is cleared to treat. Or maybe the device simply did not work for them. It doesn't work for everyone - and Lexington is well aware of that.