Healthy Mouths

A couple weeks before he was scheduled to have his teeth cleaned, Gerald Zember felt a slight pain in the back of his mouth. The retired lawyer figured he had burnt his tongue sipping hot soup or developed an ulcer from one too many spicy meals. And at first glance, Zember's Ft. Lauderdale, Fla., dentist, William Balanoff, didn't notice anything unusual during a routine examination--until he pulled out a new oral-cancer screening tool called ViziLite. After Zember rinsed with a raspberry-flavored acetic solution, Balanoff inserted a ViziLite light stick into his patient's mouth. Suddenly, a tiny white lesion became visible on the side of Zember's tongue. "It was tiny, but I couldn't explain it away," says Balanoff, since Zember had no history of canker sores that could have left such a mark. Zember, 78, did have a history of smoking, though, which put him at higher risk for oral cancer. So Balanoff referred him to an oral surgeon to have the lesion checked out. A biopsy revealed the cells were cancerous. "It was so tiny, I might not have noticed it until a year or a year and a half later [once it had grown]," says Balanoff. "By then, it would have been a stage-three cancer, and his chances wouldn't have been that good." About 30,000 Americans will be diagnosed with oral or pharyngeal cancer this year, and more than 8,000 people will die from it. The death rate--about 50 percent over five years--hasn't changed much in the past few decades, in part because the cancer often isn't detected until it's visible to the naked eye. "Probably about two thirds of the cases at the time of diagnosis and treatment are already at an advanced stage," says Sol Silverman, a professor of oral medicine at the University of California, San Francisco, and an oral-cancer spokesman for the American Dental Association. "So what can we do today? Early detection." Over the past few years, the American Dental Association has made detecting oral cancer earlier a priority, launching an awareness campaign in 1999. But it's taken a little while for the new screening tools to catch on. ViziLite, manufactured by Phoenix-based Zila Pharmaceuticals, was approved by the Food and Drug Administration in November 2001, but not widely marketed until this year. Another device, OralCDx's oral-brush biopsy, which uses a specialized brush to collect several test cells from the tongue's surface, has been available since 2000. But it was only this year that Delta Dental Plan of Michigan and its affiliated plans in Ohio and Indiana became one of the nation's first dental benefits providers to include the diagnostic tool, distributed by Sullivan-Schein Dental, as part of its standard benefits (DaimlerChrysler was the first employer group to incorporate the benefit for it's 400,000 union workers). Soon there may be another option, too. Zila's OraTest, a patented five-minute mouth rinse that uses a special dye, has already been approved for use in more than a dozen other countries, but still awaits approval from the FDA. Studies have shown such screening tools to be more effective than the naked eye at spotting potentially cancerous irregularities in the mouth. Findings from one study at the University of Malaya in Kuala Lumpur, Malaysia, presented at an International Association for Dental Research conference in Hawaii last spring, concluded that "glowstick" tools like ViziLite are not only effective in the early detection of oral cancer but "may prove to be cheap, safe and non-invasive innovative tools for screening high-risk individuals in clinics, health centers and remote areas." Still, dentists say screening tools have been slow to catch on--in part because they are uninsured and expensive. (Patients can pay between $50 and $120 out-of-pocket for a ViziLite test). Many dentists may feel there's little need to use a screening tool if they haven't already seen something unusual; those who use the devices may screen hundreds, if not thousands, of patients before they spot a suspicious lesion. And some insurers argue that the jury is still out on the efficacy of the tools. Unicare, a WellPoint division that is the nation's largest independent dental network, says the independent U.S. Preventive Services Task Force has so far found "insufficient information" to recommend or discourage such additional devices. Nonetheless, it is reviewing ViziLite as an option for its members. This summer, the ADA voted to allow ViziLite to be covered under a code used by insurers for prediagnostic tests to help with insurance reimbursement; the code goes into effect on Jan. 1. Balanoff is hopeful that more insurers will become amenable to including such screening tests in their coverage plans in the future. "It's a lot cheaper to pay for an oral screening than for the treatment of phase-three or -four cancer," he says. Indeed, Delta Dental, one of the nation's largest dental benefits companies, estimates it costs $200,000 to treat an advanced case of oral cancer, ranking it among the most expensive cancers to treat. In the past, screening tools have often been used only for patients considered to be at the highest risk for developing oral cancer: those over 40 with a history of drinking or smoking. But that's changing, as well, as new data shows more Americans under 40--including many who are not regular drinkers or smokers--are developing the disease. "We thought we had pretty well identified those who are at risk, and now we have found that 25 percent of those developing oral cancer don't appear to have any risk factors, which basically means screening everybody," says Tim Rose, the former president of the ADA who initiated the Oral Health Campaign and also serves as a member of Zila's board of directors. "This will become the standard of care," he predicts. Then, perhaps, there will be more stories like Gerald Zember's. His lesion was identified and biopsied so early that he required only minor surgery to remove the cancer from his tongue. The entire procedure, he says, lasted less than an hour, and he was able to eat soft foods the next day. By the time he went back for a checkup a couple months later, there were no signs of the cancer. "It's totally cured," says Zember. "I probably owe my life to Dr. Balanoff for detecting it so early. I'm very appreciative." Correction: This story originally reported that Zila expects FDA approval soon for its OraTest product. That did not accurately reflect what the company has said about the approval of OraTest. "It is the policy of Zila not to speculate on the timing of FDA actions," the company's general counsel said in a statement.

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