08/13/2014    Adam Ullman

The High Cost of Topical Anti-Fungals (David E. Gurvis, DPM, DPM)

The high costs for any new treatment is due to
exorbitant costs associated with developing the
product and bringing it to market. Before any new
product or medical device is able to be sold, many
companies spend years, sometimes decades, running
extensive clinical studies and seeking approval
from the FDA.

In order to prove efficacy and safety to the FDA,
doctors, patients and scientists, studies must be
completed. These costs need to be amortized for
the sold drug and for failed drugs as well. It’s
the only way that doctors (and the FDA) can have
the data needed to know if a treatment is safe and
effective.

With this said, the efficacy rates associated with
treatments for onychomycosis are typically very
low and that is because treating the shoe
environment has not yet become part of the
treatment protocol. Since 1954, studies have shown
shoes to be highly contaminated and yet billions
of dollars are still spent annually for treatments
with an efficacy of 5-38% (complete cure for
Penlac to Lamisil) that only address part of the
problem and ignores the footwear.

Many podiatrists half-smiling have told me they
recommend Lysol for shoes. Why? This is not only
an off label use of the product, but they are also
prescribing the use of this product against the
manufacturers recommendation (a can of Lysol
states to not use on clothing or in contact with
skin)! Why recommend anything that doesn’t have
the data behind it worthy of the credentials of
Doctor of Podiatric Medicine?

As doctors, your patients should listen to you and
trust your recommendation. A clinically proven
solution should cost more because it’s backed with
data that should make you feel secure in putting
your credentials and medical reputation on the
line.

An example where data is critical is that chlorine
will kill microorganisms; however, if you dilute
one drop of chlorine in a gallon jug of water it
will likely do nothing. Just because something has
an active ingredient that may be effective does
not mean an untested product will have those same
results. This is why data and tests of the
specific product are important for the FDA and why
it should be important to you too.

With the SteriShoe sanitizer, we offer the only
clinically proven way to sanitize shoes. We offer
the only shoe sanitizer with a study published in
JAPMA.

As Dr. Gurvis said, “Do what is right for your
patient and you won’t go wrong.” When dealing with
onychomycosis give your patients the best tools
available and prescribe a complete protocol --
treat the reservoirs of infection in the shoe with
a clinically proven product.

Adam Ullman, President & CEO, Shoe Care
Innovations, Inc., adamullman@sterishoe.com

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