THE AGONY AND THE ECSTASY

How The OxyContin Crackdown Hurts Patients In Pain

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
re-establish 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 opioid 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 160 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 is a writer living in Japan.