The Agony and the Ecstasy

How the OxyContin crackdown hurts patients in pain

Melinda Ammann from the April 2003 issue

(Page 2 of 3)

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."