Policy

Can Pain Treatment Survive Our Addiction to Law?

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Last year I suffered what doctors called a spontaneous pneumothorax -- a partial lung collapse. The condition was not dangerous, but treating it involved punching three holes between my ribs and scouring my chest cavity to produce scarring. What followed was pain so intense I felt incapable of motion or thought. I was beginning to panic when a nurse brought in a pill, one so little I had to squint at it. "OxyContin," she said. I took it, expecting not much, but before long the pain receded. I could walk, I could read; I felt pretty good. Best of all, the single pill lasted through the night. I slept long and well and gratefully.

Apparently I was the only person in America who had not heard of OxyContin, which has found itself caught in a crossfire between medicine and law. OxyContin contains a synthetic opiate called oxycodone, which is formulated for slow, continuous release (thus the name, "oxy" plus "contin"). It is manufactured by Purdue Pharma of Stamford, Conn., which introduced it in 1995. Doctors welcomed it enthusiastically. Unlike earlier narcotic pain relievers, OxyContin could treat serious pain for 12 hours at a stretch with hardly any side effects.

Well, one side effect. Like all opioids, OxyContin can get you hooked. It is in the same family as morphine and is just as addictive.

That is not as addictive as you might fear. When medical opioids are taken as prescribed, addiction is rare. Many physicians believe opioids remain, if anything, underprescribed, given their relative safety. "We're coming out of an era that we call opiophobia," says Jeff Reinking, a pain specialist in Sacramento who has taken speaking fees from Purdue Pharma in the past. Studies suggest that tens of millions of Americans suffer from chronic pain of one sort or another. "We do know after 25 years," says Reinking, "that pain becomes a disease in the body, because you have nerves firing uncontrollably all the time." Opioids, administered conscientiously, can offer safe relief.

In the 1990s, Purdue marketed OxyContin aggressively. Executives believed the drug would help millions of people, which it did, and would earn a lot of money, which it also did. By 2000, OxyContin ranked 36th among all prescription drugs in the United States, and last year its sales reached almost $1.5 billion. Because OxyContin releases painkiller in a low, steady dose that brings no rush or high, Purdue expected it to be, if anything, less likely to cause addiction and abuse problems than competing opioids.

What Purdue did not expect was that drug abusers would learn how to defeat the time-release feature by crushing OxyContin and then snorting or injecting it, to get a heroinlike high. A wave of abuse began in Appalachia and then radiated across the country, hitting rural areas particularly hard. Officials in Washington County, in the far northeastern corner of Maine, told The New York Times recently that OxyContin crimes there are 10 times more prevalent than in 1998 and that at least 1,000 residents are addicted. In suburban and rural Northern Virginia, armed robbers have been systematically knocking over pharmacies that stock OxyContin. Even Alaska is now reporting problems. The Drug Enforcement Administration suspects OxyContin abuse in 300 or so deaths in 31 states over the past two years (though in many of those cases, oxycodone was only one of several substances abused). Police and prosecutors have gotten busy confronting the spreading problem, as they should; but in doing so, they have also pushed the law to or beyond its intended limits.

In February, a Florida jury set a new precedent by finding Dr. James Graves guilty of four counts of manslaughter for prescribing OxyContin to patients who subsequently died. He was also convicted of one count of racketeering and five of unlawful delivery of a controlled substance. On March 22, Graves was sentenced to 63 years in prison. According to Ed Ellis, one of his defense attorneys, if the 55-year-old Graves loses his appeal, he will spend the rest of his life in prison. Good, said Lester Daniels, whose son was among the four dead. "As long as he never sees outside prison walls, that's great for me," Daniels told the Associated Press. "He's slime. He's pure slime."

Maybe, maybe not. The state charged Graves with prescribing OxyContin and other narcotics for money -- $500,000 a year -- to people who were obviously abusing them, to the point of holding tailgate parties outside Graves's office. "He is no different than a drug dealer," a prosecutor told the jury. Graves flatly denied the charge, saying he ran a reputable practice and was deceived by addicts, who are practiced deceivers. "I did not actively prescribe the drug to any … that I knew to be active addicts, and there were no tailgate parties or anything as described by the prosecution going on outside my office," he told ABC's Good Morning America in a jailhouse interview.

In any case, no one denies that the four people with whose deaths Graves was charged were energetic drug abusers who worked hard to harm themselves. Two of them, for instance, cooked up OxyContin and injected it. Another mixed alcohol with the sedative Xanax as well as possibly using OxyContin.

In California, a doctor who claims his only crime is aggressively treating pain among low-income patients has been charged with manslaughter for prescribing too much OxyContin. That charge was reduced from an initial indictment for murder. In Florida, a doctor has been charged with first-degree murder in connection with an OxyContin overdose. The victim in that case took a lethal combination of tranquilizers, alcohol, and OxyContin. This man was murdered by his physician?

Just last week, yet another Florida doctor was arrested in her office for prescribing unneeded painkillers, including OxyContin. Her bond was set at nearly $2 million. One result of these prosecutions and the attendant publicity will be to make doctors more careful about prescribing OxyContin casually. Another will be to make some doctors reluctant to prescribe OxyContin at all; why take the chance?

Meanwhile, Purdue Pharma is facing more than 50 civil lawsuits relating to OxyContin addiction. One of those was filed by the state of West Virginia, which wants civil penalties and restitution for its costs in treating and coping with addiction. In Virginia last year, a lawyer for plaintiffs in a $5.2 billion OxyContin lawsuit called companies such as Purdue "corporate drug lords." The Roanoke Times reported that lawyers likened the suit "to the massive litigation brought against tobacco companies."

The legal theory of these cases is that Purdue's initial marketing downplayed OxyContin's addictive potential and, by recommending the drug for moderate as well as severe pain, encouraged overprescription. "There is a strong view among plaintiffs that the drug was overpromoted," said Jon Hinck, a plaintiffs lawyer with Lewis Saul & Associates, in Portland, Maine. Plaintiffs took the drug as prescribed, he said, yet ended up "coping with a severe, debilitating addiction, and whatever original or residual pain issue they have becomes entirely secondary in terms of the difficulty they face in their lives." Asked about potential damages, Hinck said, "I don't want to sound glib, but in some respects the sky's the limit, because if you talk to people who've been saddled with a severe addiction problem, their lives can simply unravel."

Purdue retorts that so far all the plaintiffs it has seen have turned out, in discovery, to have had "a significant and substantial history of drug abuse," as Howard R. Udell, Purdue's general counsel, puts it. Moreover, Purdue argues that the drug was always marketed—in accordance with federal law—as potentially addictive. As for "moderate" pain, "If you have moderate pain for a few minutes, that's not a problem," says Purdue's J. David Haddox. "If you have moderate pain 24/7, that's a big problem."

Purdue concedes that the "ideal plaintiff"—someone who had no history of drug abuse, who took OxyContin as prescribed, and who got addicted—may yet come along. "Clearly, this is an opioid analgesic, and it has the potential to addict," says Udell. I asked Sally L. Satel, a Washington, D.C., psychiatrist who specializes in treating addiction (and who is also a fellow of the conservative American Enterprise Institute), what she would recommend to a patient who became addicted as a side effect of taking OxyContin. "You go to a drug-treatment program, not just run to a lawyer—I don't get it," she said.

Having been treated last year in hospitals on both coasts, I can attest, with gratitude, that the American medical establishment is taking pain seriously, after years of treating it, too often, with a shrug and a wave. Now the question will be whether that progress can withstand America's addiction to law.