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New laser treatment takes aim at toenail fungus

Rating

2 Star

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New laser treatment takes aim at toenail fungus

Our Review Summary

Near the end of this story, we meet a man named “Richard,” and describes him as “a retiree in Fairfax who did not want his full name associated with toenail fungus”. We wish the Washington Post had considered a similar level of discretion when choosing to pursue this story.  Even though it tosses in a few counterpoints, and crucial cost information, the overwhelming impression left by this story is that lasers are the answer for fungal nails.

 

Why This Matters

It’s hard to understand what prompted a paper as good as the Post to devote this much space to an expensive cosmetic treatment with no proven health benefits or even long-term cosmetic benefits. News outlets, of course, have to cover new and emerging trends in treatment, but they should not throw most of their weight and credibility behind the new while slighting the old, as this story did.  Some estimate that 10% or fewer of adults in the US experience toenail fungus. For most it is a minor nuisance. For some, especially those with diabetes, it can be a major problem. It is hardly the public health menace that the story suggests.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story did a good job on this point. It noted that one treatment “costs about $1,000 and is not covered by insurance.” It put this into a larger context by saying, “Last year, Americans spent $354 million on prescription and over-the-counter treatments for toenail fungus, according to IMS Health, a health-care information company.” And it described at the end of the story how one patient has tried to fend off reinfection by buying a $130 sterilization kit for his shoes.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The benefits are not well quantified. The FDA approved the Pinpointe FootLaser noting it is, “substantially equivalent to the predicate devices and is safe and effective for use for the temporary increase of clear nail at 6 and 12 months following treatment in patients with onychomycosis.” We are unable to locate any studies comparing it or any laser to prescription drugs in the treatment of toenail fungus. We think that the story was a bit over the top in its enthusiasm.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The story provides absolutely no information on harms or potential harms of the laser approach. While the risk may be low, lasers do present risks. Instead, the story says, “Kominsky has treated 400 to 500 patients with the PinPointe laser. Compared with oral medication, he says, ‘the odds of success are better with the laser; plus, there’s no side effects.'” A doctor selling laser treatments should not be allowed to make these kinds of claims without proof. The folks at Novartis have every right to be miffed that they were held to a higher standard. We did appreciate that the story mentioned reinfection. “Even John Strisower, the founder of PinPointe USA, says patients should expect at least a minimal reinfection within five years after laser treatment.”

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

For some reason, the story takes a shot at the one of the more proven treatments for foot fungus. “The most common oral treatment, Lamisil, works for about two out of three patients, according to Lamisil’s FDA-approved prescribing information, but it has been associated with rare cases of serious liver problems. Other potential side effects include diarrhea, headache, rashes and changes in taste. According to Lamisil’s manufacturer, Novartis, the relapse rate is 15 percent one year after completing treatment.” There is no similar information presented for these laser treatments. Instead, there is a subhead that says, ‘No side effects.’ Only one study is mentioned, and it’s for a laser treatment not yet approved by the FDA. The complete lack of evidence should have been a bigger issue in the piece.

Does the story commit disease-mongering?

Not Satisfactory

This is where the story really sunk low. It frames the story like “Jaws” for people with funky feet.

“For people with toenail fungus, there is no good time to wear sandals. Not even at the beach in July. Toenail fungus causes nails to become thick, yellow and brittle in a way that looks pretty ugly and can be painful.”

We can just see the readers reaching for their shoes as they read that lead. No way are they going to the beach after reading this. It gets worse, though.

“Sufferers can spend years and hundreds of dollars trying to clear the infection with drugs, topical treatments and home remedies, sometimes to no avail.”

When will the agony end, the readers ask themselves. Cue the dramatic music, as Washington podiatrist Stephen J. Kominsky leaps up out of the page to say: “The problem is huge. It is bigger than you can imagine. …I would say 70 percent of the patients who come into my office have fungal infections on their toenails.”

Kominsky goes unchallenged for most of the article, despite his apparent lack of documented proof for any of his statements and the fact that he has every incentive to want to sell these treatments to the feet shy masses.

Finally, profiling one patient who “did not want his full name associated with toenail fungus” paints this as a scourge of society.

This is some pretty classic disease-mongering at play.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

There are multiple sources quoted and some are critical of laser treatment, but, on balance we thought too much weight was given to a conflicted physician and a conflicted study. The physician who is quoted the most frequently is heavily selling these treatments. And the only study presented as proof of the laser treatment’s efficacy is also the only study being promoted on the website of the company highlighted in the story, PinPointe USA. The author of that study is the head of PinPointe’s Advisory Panel. http://pinpointefootlaser.com/news-and-events/press-releases/dr-adam-landsman-appointed-head-of-pinpointe-usas-advisory-panel This should have been noted in the story.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story does mention multiple alternatives, but it also knocks each one of them down. Lamisil “has been associated with rare cases of serious liver problems” and other “potential side effects include diarrhea, headache, rashes and changes in taste.” Then the story quotes a podiatrist who does not use lasers but never says what he does use. Instead, he lists a litany of treatments that don’t work. “Firestone also says that over-the-counter antifungal nail creams and ointments rarely work because they can’t penetrate the nail root. Home remedies such as tea tree oil, bleach and vinegar also don’t work, he says.” Then we are introduced to Richard, the first-name-only guy with foot fungus. He is presented as a success story for laser treatments. The story says, “his nails were fully cleared of the yellowed, thickened look after a year.” We think that, on balance, the story did not fairly compare the new approach with existing alternatives. Instead, it stacked the deck against these alternatives, leading readers to conclude that lasers would be the best choice.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story says, “Last year, the Food and Drug Administration cleared the first laser, PinPointe, for “temporary increase of clear nail” in patients with onychomycosis, the medical term for a fungal infection of the nail. The FDA cleared a second one, GenesisPlus, in April. Practitioners have been using other lasers on toenail fungus since about 2009.” This covers the necessary bases.

Does the story establish the true novelty of the approach?

Not Satisfactory

There are many claims of success in this story but no proof that the treatment is truly novel or that it truly represents “hope.” Lasers have been used off label to treat toe nail funges for several years, as the story notes.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story is not based on a news release. We are going to give this one the benefit of the doubt but wonder where some of the information about the success rate with the Pinpointe FootLaser comes from. The only source we could locate was the company’s press release noting approval of the device by the FDA.

Total Score: 3 of 10 Satisfactory

Comments (2)

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Moe

June 15, 2012 at 11:00 am

I have heard really great things about laser treatment for toenail fungus surgery. It seems to be working well for a ton of people. I love that there are laser treatments for almost everything now. All that you have to do is make sure that the place that you get the work done has a lot of experience and great reviews.

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