Here's a message some folks don't want you to hear about athlete's foot, that itchy scourge of pool season: No matter what the package says on whatever cream, gel, powder or spray treatment you buy, the fungus is not certain to go away quickly. In fact, it may not go away at all unless you follow the product directions closely -- which very few people do -- and even then, there's no guarantee the product will fully eradicate the fungus.
That's the consensus of two Food and Drug Administration (FDA) advisory committees that met together last month at the agency's Rockville headquarters. Several drug company and industry executives also participated in the panels' meeting.
Among the matters considered by the committees or now before the FDA:
* some product makers' requests to market shorter-duration treatments (five days instead of the current one-week and four-week regimens)
* the limited effectiveness of products now on the market
* what the agency characterized as insufficient patient directions on some product packaging.
The upshot: All parties agreed improved labeling, at least, was in order. Charles Ganley, director of the division of over-the-counter drug products, went further:
"We felt that the emphasis of [athlete's foot product] development programs [by some companies] was driven by marketing to shorten treatment regimens at the expense of finding the regimen most likely to yield the best results," he wrote in an e-mail response to a reporter's query about the meeting's purpose.
Not Just Your Feet
Thomas Nigra, chairman of the department of dermatology at the Washington Hospital Center, salutes the agency's efforts to hold antifungal makers more accountable for product claims. Athlete's foot, he says, is generally a benign condition, but it's "a bear to treat" because the slow-growing fungus that causes it is also slow to respond to treatment.
The fungus that causes athlete's foot grows easily in moist spaces such as shoes and is generally found in public spaces such as the floors of gyms and public showers. The fungi sprout tendrils that easily enter any opening on the outer layer of the skin such as a cut or abrasion. In response, the next layer of skin grows excess cells that push out, causing the surface layer to become scaly and thick. Most commonly, athlete's foot is itchy on the sole or between toes.
Left untreated, the condition can cause bacterial infections, especially in people with underlying conditions such as diabetes or swelling in their feet and legs, said Nigra. And contrary to popular belief, athlete's foot is not necessarily limited to the nether parts of the body: Scratch affected feet and then another area of your body, and the fungus can spread to your groin, scalp or underarms.
Experts generally agree that athlete's foot products are effective. At issue for the FDA, however, is whether the products actually cure the infection.
Novartis, for example, reports an effectiveness rate of 64 percent for its Lamisil AT. Schering-Plough reports an effectiveness rate of 60 to 70 percent for Lotrimin Ultra, another top seller.
But the FDA's Ganley takes issue with those numbers. He put the rate for a complete cure -- meaning no fungus would show up under a microscope, and no symptoms would be left on your feet -- at no higher than 30 percent after a full course of treatment.
Other experts, including most of the committee members who met in May, say an effective cure -- meaning most symptoms abate and there is no sign of fungi under the microscope -- is a more realistic standard.
Complete cure is not always possible, Doug Bierer, vice president of regulatory and scientific affairs for the Consumer Healthcare Products Association (CHPA), told the group, because "some clinical signs take longer to improve or may not fully resolve."
What's more, argued Novartis vice president Helmut Albrecht, the higher standard isn't needed: "We know that patients are equally satisfied whether they achieve the effective treatment or complete cure endpoints."
"Even after a full course of treatment you can still have skeletal structures of fungi that can cause mild symptoms, but the condition is effectively taken care of," said Boni Elewski, president of the American Academy of Dermatology, who testified at the meeting as a consultant to CHPA, a trade group representing makers of nonprescription products.
The FDA will consider the advice over the next few months, said Ganley. This could result in more advice for consumers on how to use current products and changes in how future products are tested.
Addressing Bad Habits
Until recently, most athlete's foot products generally required twice-daily use for four weeks, though complete healing might take several weeks after finishing the treatment.
The one-week treatments tend to be more expensive than the four-week ones. Company spokesmen say one tube should suffice. If you have the infection on many areas of one foot or on both feet, opt for a larger tube.
The one-week products come in 12-gram and 24-gram sizes. A large tube of Lamisil AT cream cost $16 last week at a Silver Spring CVS. Lotrimin Ultra, the other one-week product, is similarly priced.
If it's cost savings you're after, store-brand generics are cheapest. The largest size of one four-week cream, generic clotrimazole from CVS, recently cost $7.99 for 30 grams. How many tubes you'll need varies: Nigra advises buying the largest size to be sure it will last for a four-week treatment.
"If insurance will pay [for a prescription treatment] and just leave my patient with a small co-pay, I'm likely to prescribe a prescription product, many of which are identical to the OTC ones, and save the patient money," said Elewski.
One reason athlete's foot products don't perform better, the committees agreed, is that consumers don't follow package directions. Data collected by Schering-Plough show that consumers use these products, even those requiring four weeks of use, for only an average of 7.3 days. Schering-Plough and the CHPA have proposed including wording on the package that the product must be used for the full time specified -- something they can't do without the FDA's blessing. The agency is now considering that.
Nigra said most people can get rid of athlete's foot symptoms and prevent their recurrence by following package directions to the letter and maintaining good foot hygiene, such as by drying feet carefully after showers; wearing cotton socks, which deter the fungus; and covering feet when in public spaces.
Ganley also noted that shoes can be a source of infection. She suggested that people who typically wear one pair and have recurring athlete's foot treat their feet but also throw the shoes away.
Francesca Lunzer Kritz frequently writes for the Health section about the drug industry.