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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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