Oxycodone

WILLIAM E. HURWITZ spent much of last year trying to find new doctors for his patients. It wasn't easy, since physicians often are reluctant to treat chronic pain. They worry that repeated prescriptions for large doses of narcotic painkillers will attract unwanted attention from the government. That anxiety was the main reason Hurwitz had ended up treating so many people for pain--about 300 patients suffering from cancer, rheumatoid arthritis, degenerative disc disease, diabetic complications, and other painful conditions. Some of them had searched for months or years, growing increasingly desperate, before finding him. Many lived hundreds of miles from his Northern Virginia office.

Hurwitz's retirement was not exactly voluntary. A veteran of battles with state regulators and the Drug Enforcement Administration (DEA), the 57-year-old internist saw more trouble on the horizon. After learning that he had been targeted by a federal grand jury investigation of prescription drug diversion, he decided to gradually transfer his patients rather than put them at risk of suddenly losing access to pain medication.

Hurwitz was still working to match patients with new doctors in November, when the DEA raided his home and office. "There are patients in Vermont, Massachusetts, Maine, Connecticut, West Virginia, Virginia, Kentucky, Tennessee, North and South Carolina, and Florida for whom possible referrals are needed," he said in a written statement. In the raid, DEA agents "took patient files, financial and other records, my cell phone, and miscellaneous items. They also copied the hard drives on many of my computers and took my server, as they did not have the equipment to copy this in the office. Fortunately, I had backup files and was able to reestablish my computer network and resume patient care."

But the raid reinforced Hurwitz's concern about his patients' future. "The stigma that these people suffer, both as pain patients on opioid medications in general and as former patients of accused doctors in particular, tends to foreclose most opportunities for effective continuing care," he said last August in a written statement that announced he would be closing his practice. Last summer one of his patients told The Washington Post, "If I go to a doctor and mention [Hurwitz's] name, they won't even touch me. All I'm concerned about is getting rid of this excruciating pain." Another said: "I don't know what I'm going to do. While the criminals who are diverting the drugs get jailed, the innocent patients get the death penalty."

Facing the prospect of criminal prosecution after two regulatory actions against him, Hurwitz certainly understood why doctors are leery of pain patients. Hurwitz lost his state medical license and his federal prescribing privileges in 1996 after the Virginia Board of Medicine and the DEA accused him of excessive prescribing. (See "No Relief in Sight," January 1997.) More than 50 of his patients testified on his behalf at the board's hearing, and pain experts came to his defense, describing the large doses of narcotics he prescribed as reasonable and appropriate. His Virginia license was restored in 1997, and in 1998 he resumed his practice after the DEA reinstated the registration that allows doctors to prescribe controlled substances.

Four years later, however, Hurwitz was giving up. "These aggressive and ill-informed prosecutions convey a message of intimidation to doctors and indifference to the plight of patients in pain," he said in his August statement. "Not even the most honest and competent doctors can practice pain medicine with any assurance of safety for themselves or continuity of care for their patients."

The OxyContin "Epidemic"

The focus of the investigation that finally convinced Hurwitz to stop practicing medicine was OxyContin, a drug that in recent years has been portrayed as a seductive, deadly menace. The news media have advertised its "heroin-like high," generating interest among drug users and alarm among politicians. U.S. Rep. James Greenwood (R-Pa.), who held hearings on the subject in August 2001, asserted that "OxyContin is to prescription drug pain relievers what jet fuel is to unleaded gasoline." That year the Food and Drug Administration (FDA) slapped a "black box warning" onto OxyContin declaring that it has "an abuse potential similar to morphine." The DEA has identified OxyContin as "a major drug of concern," putting it alongside Ecstasy, cocaine, heroin, methamphetamine, and marijuana. Attention from the government has triggered more press coverage, which in turn has egged on drug warriors who are convinced we are in the midst of an "OxyContin epidemic."

For Hurwitz's former patients and other people in pain, OxyContin is not an agent of a metaphorical disease; it is a medication that helps relieve the suffering caused by their all-too-real illnesses and injuries. Introduced by Purdue Pharma in 1995, OxyContin is a 12-hour, timed-release form of oxycodone, a synthetic opiold that has long been available in products such as Percocet, Percodan, and Tylox. OxyContin quickly became the most prescribed narcotic on Schedule ii of the Controlled Substances Act (the most tightly regulated category of medication), with about 7.2 million prescriptions in 2001. It was a godsend for patients suffering from moderate to severe chronic pain, who could use it to get steady relief throughout the day.

Because some versions of OxyContin contained large doses of oxycodone (up to 16o milligrams), unmixed with analgesics such as acetaminophen or aspirin, it appealed to drug users looking for a handy way to get high. They discovered they could get all the oxycodone at once by crushing the tablets and snorting the powder or mixing it with water and injecting it. The crackdown triggered by such nonmedical use has made doctors wary of OxyContin. "While complete data for 2002 [are] not available," Purdue Pharma reports, "the growth in the number of prescriptions written has dropped compared to 2001." The government's response to OxyContin abuse also has increased doctors' apprehension about prescribing narcotics in general. The upshot is unnecessary suffering by patients who have trouble getting adequate pain treatment.

The consequences of an unreasonable aversion to narcotics, which pain experts call "opiophobia," can be severe, even deadly. In a May 2001 report to the American Society for Action on Pain (ASAP), a Kentucky physician said a former patient, a paraplegic with severe chronic pain, had killed himself. The man's new doctor, alarmed by official warnings about OxyContin, had drastically reduced his dose, leaving him in agony.

Skip Baker, ASAP's president, has collected petition signatures from thousands of pain patients concerned about the loss of effective treatment. "Many of them mention that they were taken off OxyContin because of the 'bad press' about it after having been on it for years," says Baker, who suffers from chronic pain caused by ankylosing spondylitis and fibromyalgia. "It has really been a crisis for us. Even my good pain doctor will not prescribe OxyContin, even though he knows it's the best pain medicine ever made. He admits that it's all because of how law enforcement's efforts have made it look so bad that doctors dare not prescribe it."

Looking Over Doctors' Shoulders

The negative publicity surrounding OxyContin has aggravated a longstanding problem. Beginning in the 1970s, studies repeatedly have found that pain is undertreated even in hospitals and nursing homes, even with patients on the verge of death. Last July an expert panel convened by the National Institutes of Health (NIH) confirmed that people with cancer still suffer needlessly from pain.

One member of the NIH panel, Dr. Paul Frame of Rochester University's School of Medicine, said restrictions aimed at preventing nonmedical use were partly to blame for the undertreatment of pain. "Sometimes doctors don't want to go to the hassle of prescribing a triplicate drug," he said at a press conference, referring to the special forms required by some states for strong painkillers. "They may decide to use something less effective instead."

In response to concerns about OxyContin abuse, states are monitoring painkiller prescriptions even more closely. Virginia, for example, does not require triplicate forms, but starting this year it will track prescriptions for Schedule II drugs electronically, with a special focus on OxyContin. Lawmakers such as Rep. Greenwood have suggested establishing a similar monitoring program at the national level.

Privacy concerns aside, such efforts deter legitimate treatment as well as diversion for nonmedical use because it is impossible to verify pain objectively. Although physicians can take medical histories, check records, perform examinations, and do tests to confirm an injury or an illness, they ultimately have to decide whether to believe a patient who says he is suffering. Knowing that their judgment may be second-guessed by state or federal regulators, with consequences ranging from disruption of their practices to professional ruin, they naturally are reluctant to err on the side of trusting the patient.

"Pain patients are now treated like common street junkies when they turn to their local emergency rooms for help," says Tammy Alender one of the patients who signed the ASAP petition. Alender, who suffers chronic back pain despite surgery aimed at correcting the problem, is anxious to get the word out that opioids must remain available to pain patients despite the potential for abuse. "They struggle to find adequate amounts of ongoing opiate medications to treat their valid conditions," she says. "To punish the masses of valid chronic pain patients just because of the actions of the few addicts out there is insane."

The American Pain Foundation estimates that 50 million people in the U.S. suffer from chronic pain, much of it undertreated. As of April 2002, the DEA counted 146 "verified" deaths involving OxyContin--cases where OxyContin was the source of oxycodone found in someone's body but not necessarily the cause of death. Even in these cases, the subjects usually had taken alcohol or other drugs in addition to oxycodone. But let us accept the DEA's number for the sake of argument. The deaths it attributes to OxyContin over a period of two years represent just one-third of the deaths linked to acetaminophen in a single year. Yet the DEA has not declared Tylenol a "major drug of concern."

The Threat of Prison

To understand how the recklessness of a few OxyContin users can threaten the welfare of millions, consider the case of James Graves, a Florida physician who was sentenced in February 2001 to 63 years in federal prison. Graves was convicted of manslaughter and racketeering after four of his patients overdosed on OxyContin. It was the first time in U.S. history that a physician was found guilty of manslaughter for prescribing a self-administered medication that led to a patient's death. It probably won't be the last.

The racketeering conviction was based on the state's argument that Graves used his business for ongoing criminal activity by knowingly and recklessly prescribing opioids to patients without a medical purpose. Graves, who believes patients have a right to treatment for their pain, says he trusted their self-reports. His attorney, Michael Gibson, pleads a lack of technology to confirm the existence and severity of pain. "You can do an X-ray or an MRI," he says, "but it's very difficult to determine the level of pain. You might as well flip a coin looking at an X-ray."

Gibson says the DEA declined to get involved in the case because there was insufficient evidence of intent. He argues that the evidence to support the manslaughter charges was particularly weak. Two of the four patients were injecting OxyContin, which is never directed by prescription. Another took OxyContin prescribed by Graves as well as narcotics procured through his girlfriend. The fourth died of a multiple overdose including Xanax, Lortab, and a muscle relaxer as well as OxyContin. "Where does society assess fault?" Gibson asks. "When do you start making individual patients responsible for their actions?"

The prosecution argued that Graves was not sufficiently skeptical about his patients' reports of pain, and perhaps he wasn't. Patients who testified for the prosecution said they were not thoroughly examined. The prosecution also argued that Graves kept insufficient medical records, including notes on patient exams. But the precedent of a manslaughter conviction for what may have amounted to nothing more than excessive credulousness is apt to give pause even to doctors who are models of thoroughness. Gibson worries that the case will make doctors less likely to trust their patients, especially those with any history of addiction. He argues that "doctors should practice medicine, not law enforcement"--a refrain echoed by patient advocates such as William Hurwitz and the National Migraine Association.

Graves' conviction may signal a trend toward holding doctors criminally accountable for their patient's self-inflicted injuries. In July 2001 West Palm Beach physician Denis Deonarine was charged with first-degree murder after one of his patients overdosed on OxyContin. Prosecutors argue that Deonarine is responsible for the death despite the fact that the drug was self-administered by a patient with a history of substance abuse whose body at the time of death contained significant levels of alcohol and tranquilizers as well as OxyContin. At least one other doctor in Florida and one in California face manslaughter charges based on their patients' OxyContin overdoses.

In addition to lax doctors, OxyContin critics blame the drug's manufacturer for marketing it too aggressively and not paying enough attention to its abuse potential. Thrown on the defensive by these charges, Purdue Pharma has been bending over backward to cooperate with regulators. In May 2001 the company suspended sales of its 160-milligram tablet, designed for patients with end-stage cancer. Two months later, it praised the FDA'S intimidating new warning label and distributed a "Dear Healthcare Professional" letter to explain the change and highlight the risks of diversion and abuse.

The company also has promised to develop a more abuse-resistant formulation of OxyContin within the next three years. It is working on a version containing naltrexone, an opiate antagonist that would block oxycodone's euphoric effects once the pill was crushed. Although an abuse-proof alternative that retains OxyContin's effectiveness for treating pain has not yet been developed, some members of Congress want the FDA to require such a mechanism. So far the FDA has stood by its policy of approving Schedule II drugs without demanding that they incorporate antagonists. Such a requirement would further lengthen the drug approval process and could undermine the effectiveness of painkillers.

Hillbilly Heroin

The demands for immediate and drastic regulatory action are not surprising given the overheated press coverage of Oxycontin abuse, which by the summer of 2001 had become the Next Big Drug Story. "It crept down the Appalachian Mountains from Maine to Alabama," began an August 2001 report in The Atlanta Journal-Constitution, "sending hundreds of victims to morgues, hospitals and rehab clinics." Time blamed OxyContin for "a blizzard of a crime wave" cropping up in "pockets of the nation." The Cincinnati Enquirer called it the "heroin of the Midwest." Florida's Port St. Lucie News dubbed it the "new crack." Other media outlets suggested "hillbilly heroin" and "poor man's heroin."

There was a measure of truth to some of these epithets. "This is an isolated area where it's hard for people to get real street drugs," says Phil Fisher, head of the Appalachian Pain Foundation, a West Virginia-based group trying to educate the medical community and public about the benefits of OxyContin. "OxyContin is not a street drug in most places." As a legal prescription medicine, OxyContin also may appeal to drug users who are leery of black-market heroin--especially if they've seen the newspaper, magazine, and TV stories that describe how great the high is and explain how to achieve it.

A "former OxyContin abuser" interviewed by ABC in March 2002 said the drug gave him "an immediate warm feeling, feeling of well-being, almost--I don't want to say godliness, but a feeling there's nothing I can't handle." A July 2001 New York Times Magazine story, "The Alchemy of OxyContin," put it this way: "As a pill it brings potent pain relief. As a powder it brings euphoria. It takes about five seconds to effect the transformation--and not much longer to create an addict." Similarly hyperbolic reporting has been featured by other prominent media outlets, including Time, Newsweek, CBS, and even MTV, which aired "I'm Hooked on OxyContin" as an episode of its True Life series in 2001.

OxyContin was compared to heroin so many times that some people concluded it should be treated the same way. After James Graves' conviction, West Virginia state Sen. Truman Chafin suggested reclassifying OxyContin as a Schedule I drug, which would make it illegal for any purpose. Pain patients breathed a sigh of relief when other state officials, doctors, and pharmacists dismissed the idea. "To prevent terminally ill patients who are in need of legitimate pain management from obtaining a drug that effectively relieves their pain is not the answer," said the West Virginia Board of Pharmacy.

Yet increased scrutiny of prescriptions is bound to have a chilling effect on doctors' decisions about which patients to treat and how. In addition to monitoring at the state level, the DEA requested $24.6 million and 133 new positions for 2003 to strengthen its diversion control efforts. The agency has drawn up a "National Action Plan" targeting key sources of OxyContin and other opioids, including medical professionals it considers unscrupulous as well as doctor shoppers, prescription forgers, and pharmacy robbers.

"The growing national plague of Oxy addictions, overdoses, and deaths caused by the illegal activity of some doctors, pharmacists, and patients has been focused on like a laser beam by this office and other U.S. attorneys' offices," Gene Rossi, a federal prosecutor in Alexandria, Virginia, told The Washington Post in August. "If any person falls into one of those three categories, our office will try our best to root that person out like the Taliban. Stay tuned."

The menace depicted by drug warriors like Rossi bears little resemblance to the medicine that helps patients keep agony at bay. Thomas Rogers, for instance, is a healthy 31-year-old man--healthy, that is, except for the degenerative disc disease that gives him chronic back pain. He has opted to forgo spinal lumbar fusions, which would involve the removal of natural discs and the insertion of rods or screws in his back, in the hope that a less invasive procedure will soon be available. His pain has been treated effectively with OxyContin by an Atlanta-based physician for three years.

"I would give anything to have a healthy, strong back like most 31-year-olds have," Rogers says, "but this is the way things are for me, and thankfully OxyContin has given me some sort of a life since I've been taking it....As long as I have a good doctor who understands and science can produce meds like OxyContin, life is livable. I could not live with the constant pain in my lower back without the benefits of this drug?'

Gerald M.Aronoff, medical director of the North American Pain and Disability Group, has written several books and articles about chronic pain management. In his view, OxyContin is an excellent sustained-action opioid that has gotten a bad rap. "We're in a mode where everyone's picking on opioids," Aronoff says. "They are not terrible drugs.... They have a wider margin of safety than the nonsteroidal anti-inflammatory drugs" such as acetaminophen and ibuprofen, because they carry less risk to the liver and the gastrointestinal tract. Removing them from the market would mean a "major step backward in our ability to manage pain," he says.

Addicted to Pain Relief

Much of the concern about OxyContin stems from a misunderstanding of addiction. Aronoff observes that people mistakenly equate addiction with tolerance (the need for higher doses to achieve the same effect) and so-called physical dependence, changes in the body that lead to withdrawal symptoms if the drug is abruptly withdrawn. Anyone who takes an opioid like OxyContin every day will eventually develop tolerance and physical dependence, but addiction requires an attachment to the drug's psychoactive effects. "Addiction is characterized by the repeated, compulsive use of a substance despite adverse social, psychological, and/or physical consequences," says Aronoff. "Addiction is often, but not always, accompanied by physical dependence, withdrawal syndrome, and tolerance.

Conversely, people who take OxyContin and other opioids for pain may develop tolerance and physical dependence, but that doesn't mean they're addicted. Several studies conducted during the last few decades have found that patients who receive narcotics for pain rarely end up seeking the drug for nonmedical reasons. "One study found that only 4 out of about 12,000 patients who were given opioids for acute pain became addicted," the National Institute on Drug Abuse reports. "In a study of 38 chronic pain patients, most of whom received opioids for four to seven years, only two patients became addicted, and both had a history of drug abuse."

Geov Parrish, a Seattle-based writer who has been taking OxyContin for seven years, pokes fun at the confusion about addiction perpetuated by media hype. "OxyContin is a narcotic, and I am 'addicted' to it, in the sense that if I don't take it I'd get nasty withdrawal symptoms," he writes on WorkingForChange.com. "In terms of whether my body would be unhappy if I didn't ingest it, I'm also 'addicted' to a number of other prescribed drugs, and to food, water, oxygen, and my sweetie. Addiction is an overrated concept?"

Parrish says he tried various pain medications after an organ transplant left him with debilitating pain, but oxycodone is the only one that works. "If I weren't on it, I couldn't function from day to day," he writes. "And for many, many people with cancer, AIDS, and other serious ailments, it's the difference between a relatively normal life and day after day of pure hell?"

Thomas Rogers concedes that his 12-hour OxyContin dose has doubled, from 10 to 20 milligrams, since he began taking the drug three years ago. He is also well aware that he would have to go off OxyContin gradually to avoid withdrawal symptoms. But he doesn't consider himself an addict. "People like me who suffer every day aren't concerned about addiction or being labeled as druggies," he says. "We just want out of pain, and OxyContin will do it when we are being treated by good doctors. Is a diabetic person who is dependent upon insulin considered an addict? Are people who take OxyContin any different? We depend on a drug to help our pain so that we don't get depressed and suicidal. I personally don't like waking up every single morning hurting and knowing that it may very well be this way the rest of my life?'

Rogers resents anti-OxyContin crusaders who gloss over or ignore the drug's benefits for pain patients like him. "Their backs probably don't hurt," he says. "No matter what kind of drug is ever produced, there will always be people who will abuse it and give it a bad name. These people never represent the thousands of legitimate patients like me who are not addicted but depend on it for some kind of life, as pain-free as possible."

Melinda Ammann (melindaamnann@hotmail.com) is a writer living in Japan.

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