laser treatment for toenail fungus

I have been asked by some of my patients recently about laser treatment for toenail fungus (onychomycosis in medical jargon). Various practices have been advertising this treatment using a new laser technology developed by Patholase Inc. in Chico, which has spun off a company called PinPointe Laser, Inc. to promote this treatment for toenail fungus. The laser treatment is not yet approved by the FDA as effective and safe for treating toenail fungus. It has received CE certification in the European Union which addresses safety rather than efficacy, as I understand it. The laser treatment has been featured on various television shows including Good Morning America. According to the company, it is 88% effective, more effective than any other treatment, although this did not mention how long a follow up period. The ads and information I saw from the company also did not specify whether this 88% referred to a mycologic cure (negative cultures for fungus) or an overall cure (normal nails after a 12 to 18 month follow up period). I have thus far been able find no evidence that this treatment works, nor how it compares to terbenafine (Lamisil), the standard treatment right now, from any systematic studies. Although the company's advertisements mention clinical trials, the results of these do not appear to be published in the medical literature as yet. It would be great to have an effective treatment out there which did not have the side effects of Lamisil and which therefore did not require constant liver function test monitoring. Your feedback welcome... please comment if you've experienced this treatment and want to share your experience, either positive or negative, with readers of this blog.

What is clear is that the treatment, because it is not yet approved by the FDA, is not covered by any insurance plan, and costs $1100-$1200 at local providers here on the Peninsula in California. Patients are advised to use a topical treatment twice a day for the entire year or year and a half that it takes for the toenail to regrow. I saw a comment on Yelp suggesting that the effectiveness is just due to the topical therapy; however, this is unlikely in my view due to the fact that in clinical trials topical therapy, even using laquers and vehicles aimed at allowing better penetration into the nail, seem to have much less than the rate of efficacy reported by the company for the laser treatment.

The company stresses that the treatment is only a one-time 30 minute event. While this is true, like terbenafine and other treatments, it takes a year to a year and half for the new normal toenails to grow out.

Should the doctor in your family be involved in your care?

I am constantly hearing from many sources that doctors shouldn't treat their own family members and friends when asked to do so. Can anyone provide data or evidence for this? I see "ethical" guidelines about this from state licensure boards, and medical societies. My malpractice insurer says it increases risk too. My two cents: I am aware of absolutely no evidence for these "ethical" guidelines. I'd like to see a single study of this question worth anything or any date, from a malpractice insurer or otherwise, showing that worse outcomes occur when trusted family member physicians, whom a patient wishes to be involved, are involved in a patient's care.

Here's a call to action for all my former academic colleagues at Johns Hopkins, UCSF, etc. How about some evidence-based patient-centered care? Why not do a study of whether people treated by family members, or whose family member physicians are involved in their care, have better or worse outcomes? As a profession, why do we assert something we have absolutely no evidence for besides our own prejudices? For those of you who do have a good clinician in your family whom you trust, wouldn't you consult them when you're ill?

In our practice, we assert in our tag line that "everyone needs a doctor in the family" (www.myadvicedr.com). We believe that on average, people benefit from having someone they trust, who is accessible, involved in helping them choose providers, compare treatments, and help them make sure that planned procedures or treatment are really the best thing for them.
It is my aim to be just like the doctor in the family whom you trust would be. So I definitely believe that trusted doctors in the family are a big help.

I'm willing to be proven wrong, but show me the data!! I would assert that we should not make blanket assertions without evidence as we are doing now in our state boards, medical societies, and malpractice insurance companies. How about some effectiveness research?

And meanwhile, I will continue advise my patients and others: If you have a trusted physician in your family, by all means continue to call them up and ask their opinion about everything you can. Until I see the evidence, I'm going with my gut. And if you can show me some evidence, I'll promptly post it the next time I blog.