Nailed by FDA

Nailed by FDA

April 23, 1996

This essay appeared in the Washington Times on April 23, 1996

I started 1996 with two new experiences. I had a close-up photograph taken of my big toe, and I had my first personal run-in with "drug lag" -- the delayed availability of new medical therapies due to Food and Drug Administration regulation. Neither my toe nor my encounter was a pretty sight. And while drug lag happens to be an issue that I've studied professionally for several years, this was getting personal.

The photo session was in a dermatologist's office. For the past eight years I have suffered from onychomycosis. This is not a condition of pathological rhyming, but a fungal toenail infection. Onychomycosis is not a serious disease, but over time mine grew from a minor irritation to a major discomfort. Itchy red patches sprouted randomly on the skin of my feet, like some poison ivy board game. My toenails turned into thick misshapen growths that could only be trimmed with an acetylene torch; my kids would actually steer clear of me while swimming for fear of getting cut by a wayward foot.

For seven years my onychomycosis stayed confined to my feet. Then a year ago, perhaps out of boredom, it popped up on my hand. First a fingernail, then some scaly patches on a palm, then another fingernail. The handwriting was on the hand -- I could either go the Michael Jackson glove route, or I could seek medical treatment.

But for many years the treatment options were not very promising, which is one reason why I had put off going to a doctor for so long. Fungal nail infections are impervious to the various creams and ointments used to treat skin infections. An oral medication, griseofulvin, required a lengthy course of treatment, with many side effects and a high recurrence rate. Nail removal followed by topical treatment was another possibility. But my wife had once had a fingernail removed, and she thought the pain of childbirth compared favorably with that experience; I wasn't about go through a dozen such procedures.

Then, several months ago, full-page newspaper and magazine ads began to appear for a new oral drug, Janssen Pharmaceutica's Sporanox. The ads carried spitting images of my own grubby digits and promised to help me (and 10 million other sandal-challenged Americans) "KICK toenail fungus."

I had already read about Sporanox in the medical trade press. It sounded good, but another new drug, Sandoz Pharmaceuticals' Lamisil, sounded even better. An article in the British Medical Journal called Lamisil "the treatment of choice". The problem is, Lamisil in tablet form has not been approved by FDA. Lamisil tablets are available in over seventy countries, but in the U.S. only Lamisil cream, great for fungal skin infections but useless for nails, has been approved.

My dermatologist also thought that Lamisil was the better drug, but even though he had helped conduct clinical trials of it, he couldn't treat me with it. He, like I, was stuck in the waiting room of Dr. David Kessler, FDA Commissioner.

Some knowledgeable acquaintances gave me the names of several Canadian pharmacies. One Ontario store offered to ship Lamisil without any prescription at all; another said it would require an Ontario physician's prescription. But my health insurer wouldn't cover Lamisil because of its unapproved status, even though its cost, at about $600 (U.S.) for a three month course of treatment, is 40% cheaper than that of Sporanox. Nor would Sandoz let me have it under some FDA exemption; one company spokesman could only suggest that I "call back in July; maybe it will be approved by then."

Or maybe not.

In some ways my griping seems petty. My ailment is relatively minor, the drug of choice is available from a friendly neighboring nation with little hassle and at a bearable, though steep, cost, and I have plenty of time to make a decision.

But what if I hadn't known to ask about Lamisil? What if I couldn't afford it without insurance coverage? Most importantly, what if I had something really serious?

Millions of Americans do; for many of them, the treatments of choice are unavailable in the country they call home. In a poll of oncologists that my organization conducted last August, over 60% stated that their treatment of patients had been impaired at least once by FDA approval delays; over one in ten stated that this problem occurs frequently. In the words of one physician at New York's St. Vincent's Hospital, "We are a third world nation when it comes to development of cancer drugs, AIDS drugs, and other drugs for people with life threatening diseases." The situation for medical devices is no better; Dr. Joel J. Nobel, founder of ECRI, the world's foremost medical device testing organization, states: "Regulators elsewhere in the world wonder if the U.S. has gone mad."

If this is the best that FDA can do for really important therapies, then it's not about to roll out the red carpet for a toenail medication.

Why, I wonder, shouldn't my doctor's recommendation suffice for me to obtain Lamisil in the U.S.? Commissioner Kessler claims that "if members of our society were empowered to make their own decisions... then the whole rationale for [FDA] would cease to exist." Does Dr. Kessler think so little of his agency -- that if its medical evaluations were not backed up by its legal power, they would have no persuasive weight for "empowered" adults?

I have decided to try Sporanox first; it's covered by insurance, and I'm not all that keen about getting into the drug importing business. If Sporanox doesn't work for me, then perhaps Lamisil, approved or unapproved, will. But regardless of how my nails eventually turn out, I'll always have one special finger reserved for FDA.

Since the publication of the this piece in the Washington Times on April 23, 1996, FDA finally approved the drug Lamisil.