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Lamisil Almighty

Lamisil and its generic forms of terbinafine hydrochloride has been made famous by a well known character, Digger, created by Novartis, the manufacturer of Lamisil tablets. Remember the “It’s Alive – Digger” 60-second broadcast TV ads? Digger, a nasty looking microorganism gets under a nail and calls up his colorful buddies to a party, which causes the nail to grow thick, ugly and discolored. Then a giant Lamisil tablet shows up and rolls over the party eradicating the whole gang and clearing the fungal nail in front of your appreciative eyes. Remember that? Watch it on YouTube:

While it all looks very convincing, the reality for people with fungal nails is a lot more complicated, and most of them would agree that Lamisil’s efficacy is overstated.

Overstatement of Efficacy

The TV ads depict onychomycosis, a toenail infection, represented by “Digger,” an animated dermatophyte microorganism, and illustrate an exaggerated visual effect of Lamisil’s efficacy.

Here is what FDA says about Lamisil commercials:

“In the ads, Digger infects a toenail, invites a few dermatophyte friends to join him and then “settles in.”  The infection progresses as more and more dermatophytes appear alongside Digger and the color of the nail bed changes from a healthy pink to an infected and unhealthy brown color.  Over the “horizon,” a giant-sized Lamisil tablet appears, attacking and ultimately defeating the infection as it repeatedly rolls back and forth over Digger.  As the camera pans back, Digger appears to have been beaten by the Lamisil tablet as he groans and slowly crawls away, thereby eradicating the infection.

The nail bed has completely changed back to the healthy and non-infected pink color it was before the infection commenced.  Accompanying this vivid efficacy presentation is an audio voiceover promoting Lamisil, “Unlike surface treatments, Lamisil is a pill that works through the bloodstream … to target and attack the infection at its source, underneath the nail.  In fact, you can start to see clearer, healthier nails in just three months.”

The ads’ strong visuals and claims combine to give a misleading picture of the efficacy of Lamisil and the time required for clinical success.  The ads portray both a “mycological cure” (i.e., all dermatophytes, including Digger, are gone after the arrival of the giant Lamisil tablet) and a “clinical cure” (the pink healthy toe, minus all traces of affected nail), thus implying complete effectiveness for all or most patients.  These representations in the ads are not representative of the clinical trial results.  Furthermore, FDA is not aware of additional data to support these claims of guaranteed and complete efficacy.  Specifically, the Clinical Studies section of the approved package labeling (PI) states:

“Results of the first toenail study … demonstrated … [fifty-nine percent (59%) of patients experienced effective treatment (mycological cure plus 0% nail involvement or >5mm of new unaffected nail growth); 3 8% of patients demonstrated mycological cure plus clinical cure (0% nail involvement).”

“In a second toenail study of dermatophytic onychomycosis…similar efficacy against the dermatophytes was demonstrated.”

“The mean time to overall success was approximately 10 months for the first toenail study and … for patients evaluated at least six months after achieving clinical cure and at least one year after completing Lamisil therapy, the clinical relapse rate was approximately 15%.”

Your ads do not adequately communicate that, in fact, only 38% of patients in clinical trials achieved complete effectiveness or cure of their condition (i.e., a mycological cure plus a clinical cure) and some of those patients relapsed.  Moreover, your qualifying SUPER “It takes about 10 to 12 months for new nails to grow in. Results may vary” precedes your efficacy claims.  Because of the lag time between the SUPER and your claims of Lamisil’s effectiveness, the presence of an intervening and unrelated SUPER with the telephone number, and the lack of comparative emphasis placed on this information, it is unlikely that consumers will strongly associate this qualification with the claims of effectiveness in the audio and visuals of your ads.  Therefore, your SUPER would have to be appropriately placed and substantially more prominent, and your ads would need to be qualified with additional efficacy context, to overcome the message conveyed by the dominant visual graphics and audio claims that suggest a greater drug efficacy than demonstrated.”

Source: FDA Warning Letters

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