GOVERNMENT MEDDLING HURTS ADDICTS

Whom they are supposed to be helping!

Krystal began using heroin when she was 14, and soon hit bottom. But at 18, she says she is drug-free, holds down a job, attends beauty school and cares for her toddler son. She credits a relatively new medication called buprenorphine with freeing her from heroin's grip. "Amazing," "incredible" and "lifesaving" are a few of the words addicts use to describe buprenorphine, a pill that blocks heroin cravings. The problem, some say, is that Congress has made it hard to get the drug, and health professionals are pressuring the government to expand access. Available in this country since 2002, buprenorphine is an alternative to methadone, which has been used to treat heroin addiction since the 1960s. Buprenorphine is also used to treat addictions to prescription painkillers like OxyContin, Percocet and Vicodin. "It has been extraordinarily effective in the patients we have given it to," said psychiatrist Dr. Herbert Kleber of Columbia University.

Doctors say buprenorphine is longer-acting than methadone, more difficult to overdose on and easier to withdraw from. Addicts say "bupe" gives them a feeling of clearheadedness they do not get with methadone. Also, they can be treated in the privacy of a doctor's office; methadone, under federal law, is available only at public clinics.

But federal law says individual doctors and medical practices can prescribe buprenorphine to no more than 30 patients at a time - a provision aimed at preventing "prescription mills," where drugs are doled out indiscriminately by doctors trying to make a fast buck. Krystal's doctor, J. Charles Lentini, said he has a waiting list of 185 addicts - many of whom are continuing to abuse drugs while they wait. Even more problematic is the restriction on large medical practices. For example, Kaiser Permanente, the nation's largest not-for-profit health maintenance organization with 8.2 million members, operates eight medical groups around the country, meaning it can treat only 240 patients at any one time nationwide.

Bills pending in Congress would eliminate the 30-patient restriction for group medical practices while retaining it for individual doctors. The Senate passed similar legislation last year, but it died in the House. "It clearly was not our intention" that addicts have less access to buprenorphine because they go to a group practice, said Sen. Carl Levin, D-Mich., co-author of the 2000 law that paved the way for doctors to prescribe buprenorphine but also established the 30-patient limit. Levin introduced the bill now pending.

Meanwhile, the U.S. Substance Abuse and Mental Health Services Administration is working on a regulatory fix to expand access to buprenorphine. "The group practice issue we see very much as a critical barrier," said Robert Lubran, the agency's director of pharmacologic therapies.....

The Office of National Drug Control Policy estimates there are 800,000 heroin addicts in the United States, and about 20 percent of them receive methadone. The 30-patient limit on buprenorphine is not the only barrier. Fewer than 1 percent of the nation's doctors - 4,850 out of 600,000 - have received Drug Enforcement Administration certification to prescribe buprenorphine, which is manufactured by Reckitt Benckiser and sold under the brand names Suboxone and Subutex. Kleber said the manufacturer told him last year that only 1,500 doctors had written a buprenorphine prescription. Reckitt Benckiser officials did not return a call.

Many doctors shy away from treating heroin addicts because they believe those patients will be disruptive, Kleber and others said. Also, buprenorphine is expensive, at around $300 to $350 a month, and is not always covered by insurance.

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The FDA will NEVER work properly: "The President's nominee to head the FDA, Lester Crawford, faces daunting challenges. As acting commissioner for most of the past four years, Crawford has confronted a kind of perfect storm. First there were claims that the labeling of certain antidepressants failed to warn doctors that the drugs caused some adolescents to commit suicide. Then the agency was blind-sided by contamination that made half the nation's flu vaccine supply unavailable. Thereafter came revelations about previously unknown side effects of several widely prescribed anti-inflammatory analgesic drugs, and harsh criticism from within the agency about the safety of drugs generally."

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For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation.

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