Have You Heard About The Latest Onychomycosis Product That Is ‘80 Percent Effective’?

Warren S. Joseph DPM FIDSA

I was recently quoted in a very fair and balanced article on laser treatment of onychomycosis that was published in the Wall Street Journal and written by the newspaper’s Science Reporter Laura Johannes.1 During my interview with Ms. Johannes, I bemoaned the lack of published evidence not only for laser therapy of onychomycosis but for any of the recently promoted treatments, either device or solution.

I questioned the ubiquity of the claims of 70 to 80 percent efficacy that seem to be rampant. I asked her as I now ask you: What does it mean to you if I say a product is “80 percent effective”?

Think about that. Does it mean that 80 percent of the treated toenails became 100 percent cured? Does it mean that 80 percent of patients treated were satisfied? Does it mean that 80 percent of toenails reach some undefined clinical endpoint? None of this is ever spelled out.

Right in the Wall Street Journal article, Anas Khoury, DPM, notes that he has been using the Nomir Medical laser for four months. According to the article, Dr. Khoury says “it works in about 80% of his patients.”1

Ms. Johannes also notes how PinPointe USA supplied the Wall Street Journal with a summary of unpublished (my emphasis) data, claiming “71.4% of patients experienced continuous improvement over a year … .”

Let me share with you some claims right from onychomycosis promotions I have seen recently.

In a “testimonial” (the HIGHEST level of medical evidence, I am sure) on a Formula 3 topical solution brochure, a podiatrist from Nebraska states, “I would estimate (an) 80-90% success rate.”

In an advertisement for Fungasil solution seen in a doctor’s office recently, it claims, “50-80% cure rate within one year.”

Speaking to a sales representative at the Cool Touch Laser booth during the recent Desert Foot Conference, she noted, “The efficacy is 79.8%.”

From a direct mailing of a local podiatrist using laser therapy: “88% Effective, Proven Clinical Results.”

If I read a paper of a randomized, controlled clinical trial on an antibiotic therapy and there is a result showing 90 percent success, the endpoint is clearly spelled out. It may have been a 90 percent microbiologic cure (defined as negative culture) or a 90 percent clinical cure (no residual clinical evidence of infection), etc.

Even in the onychomycosis literature, when proper studies were performed on terbinafine, itraconazole or ciclopirox lacquer, you could read the studies and KNOW exactly what the endpoint was, be it mycologic cure, complete cure or something in between.

This is what is lacking in many of these claims. I find it hard to believe they all can be so incredibly close in efficacy and, frankly, how they can be … so effective!

I think we will all agree that the “gold standard” in the treatment of onychomycosis is oral terbinafine, followed closely by oral itraconazole. Yet, if you actually look at the FDA approved clinical cure numbers (clearly defined in the criteria as mycologic cure plus 100 percent normal nail appearance at the end of the study), terbinafine only had a 38 percent cure rate and itraconazole had only a 14 percent cure rate.2,3 Has medical science advanced so rapidly in the past 10 to 15 years that we can now double that success rate?

So why is a number between 70 to 80 percent used as a claimed efficacy rate for all of these various promotions against onychomycosis? I guess some may be based in clinical trials, published or not. Some of these efficacies may be absolutely true. I just do not know since, other than the published Nomir Medical study, I have not seen any data.4 This was my point in the Wall Street Journal article. Maybe docs and companies feel they need to claim 70 to 80 percent efficacy to feel comfortable selling a treatment or a product to a patient.

I welcome your thoughts and comments.

References

1. Johannes L. Fungus got your toes? Zap it. Wall Street Journal. February 22, 2011. Available at http://online.wsj.com/article/SB1000142405274870447660457615835163007632... . Accessed March 4, 2011.
2. Terbinafine package insert.
3. Itraconazole package insert.
4. Landsman AS, Robbins AH, Angelini PF, et al. Treatment of mild, moderate, and severe onychomycosis using 870- and 930-nm light exposure. J Am Podiatr Med Assoc. 2010;100(3):166-77.

Editor’s note: This blog was originally published at www.leinfections.com/category/onychomycosis/ and has been adapted with permission from Warren Joseph, DPM, FIDSA, and Data Trace Publishing Company. For more information about the Handbook of Lower Extremity Infections, visit www.leinfections.com/ .

Comments

Marketing, meet science! "Help", "relief" and "improvement" do not mean that the problem goes away, never to return.

We spoke a few years ago when I noticed that there was a warning on the label of the OTC topical antifungals: "Do not apply to scalp or nails". Turns out that the FDA required the warning since testing revealed inadequate penetration of the nail plate. Now, how can a product be marketed and sold for the treatment of fungal nails -- complete with "before" and "after" drawings/photos when this sort of warning is on the label? And why would there need to be a warning to not apply a nail medication to the scalp? It's the American Way.

I am considering buying a laser for onychomycosis. Pinpointe has a great deal going on right now. Are there any other companies offering FDA approved devices that you are aware of?

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