Addiction medication has a slow start in the U.S.

An addiction medication heralded as a breakthrough because doctors can dispense it in their offices has failed so far to generate much enthusiasm among the nation’s doctors.

The tepid reaction to buprenorphine has disappointed some doctors and patient advocates who believe that the drug has the potential to coax reluctant addicts into treatment. The drug received federal approval more than a year ago.

Buprenorphine is an opiate substitute and can be used by people addicted to heroin, prescription painkillers such as Vicodin and OxyContin, and other opiates. It is the first of the addiction medications doctors could begin dispensing in their offices during the next few years. Prescription medications for alcohol and cocaine addicts are under development or are being reviewed by the Food and Drug Administration.

According to the National Institute for Drug Abuse, there are more than 1 million opiate addicts in the United States and that number is rising. Some of the reasons include the large number of Americans, from baby boomers to the elderly, who are getting hooked on medication for chronic pain, as well as a growing and illegal trade of narcotics on the Internet.

“We’re seeing less interest than we expected, especially among primary care physicians,” says Robert Lubran, director of the division of pharmacologic therapies at the U.S. Department of Health and Human Services.

Only a few thousand addicts across the country are using buprenorphine, according to estimates, a much smaller number than expected before the drug’s approval.

By comparison, France introduced the drug in 1995 and within four years had more than 60,000 patients. One major reason is that France’s public health system is paying for the medication. Although a few U.S. insurers cover the drug’s $250-a-month cost, most private insurers and state Medicaid programs for the poor, including California’s Medi-Cal program, are not paying for buprenorphine.

In California, the number of doctors who have signed up for the federal training required before they can dispense the drug also is fewer than anticipated: about 200 physicians.

Last summer, a Boston University School of Public Health survey of doctors who have undergone federal training found that many physicians are facing hurdles in trying to dispense the drug.

Anara Guard, the researcher who oversaw the survey, says many doctors reported that they couldn’t get local pharmacies to stock buprenorphine, because the stores didn’t feel there was a big enough demand or because they were apprehensive about having addicts as customers.

Many doctors also said they were troubled by the idea of dispensing a narcotic to addicts and did not feel they had the resources in their offices to deal with patients who might be prone to volatile behavior. Doctors had been barred from dispensing narcotics to addicts since Congress enacted the Harrison Narcotic Law in 1914. Legislation passed by Congress in 2000 eased those rules.

Another problem, some doctors said, is that federal health officials have set unreasonable limits on how many buprenorphine patients each doctor can treat. The current statute limits physicians practicing solo or in small or larger groups from treating more than 30 patients at one time.

The result is that single practitioners and large-scale medical plans have the same limitations on the maximum number of patients who can be treated. Kaiser Permanente, one of California’s largest health providers, with 7 million members statewide, says it has not started dispensing the drug because the 30-patient limit would make it impractical.

Sen. Orrin G. Hatch (R-Utah) recently introduced a bill in Congress to exempt large group practices and academic medical centers from the limit.

“The regulations around this drug are too cumbersome,” says Dr. Judith Martin, an Oakland family physician who recently began treating two patients with buprenorphine. She says she is “extremely pleased” with the results so far. Some large medical providers and members of Congress are lobbying the health department to update the regulation.

A spokesman for the drug’s manufacturer, Reckitt Benckiser Inc., says sales are “lower than some original estimates” but that the company expects the numbers to increase rapidly over the next year.

Research shows buprenorphine is safer than other medications such as methadone. Buprenorphine appears to lead to fewer overdoses, a major concern with any opiate or opiate substitute, and patients appear to experience fewer relapses.

Buprenorphine is given on a short-term basis in detox centers or, more often, it’s used as a maintenance medication. The orange-colored pill is taken daily by letting it dissolve under the patient’s tongue.

Unlike methadone, buprenorphine does not produce a sense of being high. Because of that, experts say the drug has a lower chance of being illegally sold on the street, which happens with many treatment medications.

Still, the drug is not for everyone. It may not work with hard-core addicts who need a more potent medication to stave off severe withdrawal.

And some primary care doctors unused to treating addicts say buprenorphine patients present unexpected challenges. Dr. Art Van Zee, of St. Charles, Va., a small Appalachian town that Van Zee says has been “destroyed” by OxyContin abuse, says he recently stopped writing 30-day prescriptions to new patients and now insists they stop by his clinic every day. Several addicts, he says, stopped taking the medication for weeks at a time when on their own.

Van Zee remains hopeful about the drug’s potential.

“This is no magic bullet,” he says, “but I am starting to believe it’s better than anything else we’ve got.”

Lubran, of the Department of Health and Human Services, says the federal government will be heavily promoting buprenorphine during the next year by sponsoring more than 40 information sessions for doctors across the country. This spring, the department is sponsoring its first buprenorphine workshop in California for primary care doctors as part of the American Academy of Family Physicians annual conference in San Francisco.