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It is a bad time to be in pain. Last week, the maker of OxyContin, a high-strength narcotic analgesic, agreed to pay $635 million to settle charges of "misbranding" brought by the attorney general of West Virginia. "Scores died as a result of OxyContin abuse and an even greater number of people became addicted," said Attorney General John Brownlee. The drug company, Purdue Frederick, admits that its sales force underplayed the abuse potential of OxyContin. And, yes, the company should have acted more quickly to clamp down on overpromotion and to issue strong warnings in the face of overdose deaths. But the real public-health damage here comes from the pitched campaign conducted by zealous prosecutors and public-interest advocates to demonize the drug itself. This is tragic because OxyContin has been a godsend for millions of patients with searing, unremitting pain from chronic back problems, rheumatoid arthritis, neurological disorders and other dire afflictions. This latest bad rap for OxyContin threatens to inflict more pain. Doctors already wary of scrutiny by the Drug Enforcement Administration will become even more skittish about giving adequate doses of OxyContin or prescribing it at all. And patients will be rightly scared of losing access to the medication that made their lives livable again. OxyContin was approved in 1995 for treatment of moderate-to-severe pain. Unlike its opioid cousins, such as morphine or codeine which wear off in four to six hours, OxyContin is slow-release and lasts up to 12 hours. Longer action means steadier blood levels, an important feature when pain is constant and severe. Problems started in 2000 when drug abusers discovered that they could crush the pill -- thereby inactivating the slow-release feature -- and snort or inject the powdery contents for a euphoric rush that hits the brain like heroin. West Virginia was one of the first states to report people dying from abuse of "Oxy," dubbed Hillbilly Heroin. Then in July 2001 the New York Times Magazine ran a cover story, "The Alchemy of OxyContin." The author described how addicts -- not severe, chronic pain patients -- ground an intact pill into quick-acting pharmaceutical grade opiate. "It takes five seconds to effect the transformation -- and not much longer to create an addict." The startling implication was that unwitting people were stumbling headlong into a powerful addiction. Two years later the Orlando Sentinel ran a series headlined "Pain Pill Leaves Death Trail." The expose reported that 205 overdose deaths in Florida in 2001 and 2002 were linked to OxyContin. The victims "put their faith in their doctors," said the Sentinel, "and ended up dead, or broken." These portrayals were deeply flawed. The typical "Oxy" abuser is not a pain patient taking medication as prescribed, but rather a committed substance abuser. The 2002 National Household Survey on Drug Abuse found that among those who took OxyContin without a prescription, 98% had used other addictive pain relievers for nonmedical purposes and more than a quarter had used heroin. When the Kentucky medical examiner's office recorded 27 oxycodone-related deaths in 2000; in all but two, other drugs, including cocaine, heroin and other prescription painkillers and alcohol, were found in the bodies (oxycodone is the pure narcotic found in OxyContin and other pain killers). In 2003, the Journal of Analytical Toxicology reported that in less than 2% of 919 oxycodone-related deaths OxyContin was the only drug found at autopsy. The Orlando Sentinel recanted its story in 2004 after autopsies on two-thirds of the victims uncovered other drugs (e.g., alcohol, heroin, other painkillers) that alone or in combination with oxycodone could have been fatal. In the remaining one-third, no one could tell how often OxyContin itself was involved because name-brand drugs were not identified in the autopsies. Thus, the problem isn't OxyContin, but its misuse by people abetting a desire to get high. In fact, according to the National Institute on Drug Abuse, abuse of narcotic analgesics is rare among legitimate pain patients taking adequate doses as prescribed. This is not to absolve physicians. Well-meaning doctors sometimes prescribe large numbers of pills to those who may not need such high-strength medication and then refill prescriptions reflexively. Some are easily hoodwinked by "patients" who doctor shop to maintain a habit or to accumulate drugs for underground sale at $1 per milligram (the most commonly sold pill being the 40mg strength). A vast amount of OxyContin on the black market also comes from pharmacy robberies and diversion of drug shipments bound for large distribution chains. Was the penalty for Purdue Frederick out of line? I don't know. But the price for those already in pain promises to be steep. Pharmaceutical development of improved slow-acting opiate medications may be derailed by fresh paranoia. More law-abiding physicians wary of litigation and regulatory scrutiny may withdraw from prescribing potent painkillers. It is hard enough for pain patients to get treatment. This newest injection of malignant hype is the last thing they need. Dr. Satel, a psychiatrist specializing in addiction, is a resident scholar at the American Enterprise Institute. |
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