DOCTORS BEHIND BARS:

TREATING PAIN IS NOW RISKY BUSINESS

In February 1999, Dr. Frank Fisher, a general practitioner in Shasta
County, Calif., was arrested by agents from the California state
attorney general's office and charged with drug trafficking and murder.

The arrest was based on records indicating that Dr. Fisher had been
prescribing high doses of narcotic pain relievers to his patients,
five of whom died. He lost his home and his medical practice and
served five months in jail before it was discovered that the patients
had died from accidents or from medical illnesses, not from the
narcotics he prescribed.

All charges were dropped last year, and Dr. Fisher now has his medical
license back. Yet his ordeal lingers as a cautionary tale of what can
happen to doctors who treat pain aggressively.

Over the last decade or so, pain specialists and patient advocates
have diligently educated doctors about the undertreatment of
persistent and debilitating pain. But as physicians have expanded
their use of opiate painkillers like oxycodone and hydrocone, the
abuse and diversion of the drugs has also increased. This, in turn,
has led the Drug Enforcement Administration to intensify its scrutiny
of physicians.

The result is a clash of imperatives: The doctor's job is to treat
pain; the drug agency's is to stop the diversion of prescription drugs
for illicit use. And resolving this conflict has become a pressing
matter for doctors, pharmacists, law enforcement officials and patient
advocates alike.

"Pain management has become a crime story when it really should be a
health care story," said David Joranson, director of the Pain and
Policy Studies Group at the University of Wisconsin.

No one questions that abuse of opiate painkillers is a problem. But
federal and state law enforcement agents, who wield considerable power
in deciding whether to initiate investigations, as well as the
prosecutors and jurors who determine a doctor's fate if the case goes
to trial, are often misled by obsolete ideas about the practice of
pain medicine and the effects of opiate drugs.

Pain treatment itself is an area ripe for misinterpretation. Many
patients who seek doctors' help have already tried nonsteroid anti-
inflammatory drugs, conventional opiates like codeine and even
surgery, yet they are still in severe pain from cancer, degenerative
arthritis, nerve damage or other conditions. Large doses of medicines
like hydrocodone (Vicodin), oxycodone (OxyContin), morphine or
methadone may be required.

Consider the clinical experience of a colleague, a neurologist who ran
a pain service at a university medical center. He treated a young
woman who developed a number of painful disorders including complex
regional pain syndrome, psoriatic arthritis and diabetic neuropathy.
She was in so much agony that she could get around only in a motorized
wheelchair and could barely move her arms to feed herself.

Disuse led to the stiffening of her arm muscles, and surgery was
needed to release the tendons. Still, the pain was so excruciating
that her doctor had to increase her dose to a staggering 3 grams of
oxycodone per day, 90 grams per month - easily 30 to 60 times the
standard dose for a person with, say, a painful degenerative disk
disease. At this level of pain medication, she was able to get out of
bed and use her wheelchair.

It is not known how many patients need long-term treatment with
opioids, particularly at high doses. Dr. Russell K. Portenoy, chairman
of pain medicine and palliative care at the Beth Israel Medical Center
in New York, cites surveys estimating that as many as 6 to 10 percent
of Americans suffer from chronic, disabling pain. He speculates that
maybe 1 in 10 of them could benefit from long-term, high dose treatment.

This small group, however, is probably responsible for a large portion
of all the narcotic painkillers prescribed. Dr. Fisher, for example,
told Reason magazine that almost half of all the highest strength
OxyContin pills prescribed for patients enrolled in California's
MediCal program in 1998 had been consumed by 24 of his patients.

The red flags that rightly alert regulators to potential misconduct by
doctors are, paradoxically, the very features that can also mark
responsible care for intractable pain. These include prescribing high
volumes of narcotic painkillers for extended periods, prescribing
potentially lethal doses or prescribing several different drugs. In
some regions, patients use several different pharmacies, at their
doctor's instruction, because some pharmacists are reluctant to
dispense large quantities of the medications.

To complicate matters further, doctor shopping can also be a sign of
what is called pseudo-addiction: the efforts to obtain drugs look on
the surface like drug addiction, but in fact represent the patient's
attempt to attain an adequate level of pain control. Once that is
achieved, the patient no longer presses for more narcotics.

Also confusing is the distinction between addiction and physical
dependence. Physical dependence occurs in almost everyone who takes
narcotic medication regularly for at least two weeks. Addiction - a
craving for the drug and its compulsive use to regulate one's mood -
does not.

With dependence, the body adapts physiologically to the drug, and if
it is stopped abruptly, withdrawal symptoms occur. Tapering
medications prevents the nausea, vomiting, diarrhea and cramping of
withdrawal. Tolerance may develop such that higher doses of the
medication are needed for relief. Tolerance and physical dependence
are normal and reflect the pharmacologic properties of opiates.

People who are addicted to narcotics are generally dependent and
tolerant, but dependence and tolerance only sometimes indicate
addiction. In fact, when you scratch the surface of someone who is
addicted to painkillers, you usually find a seasoned drug abuser with
a previous habit involving pills, alcohol, heroin or cocaine.

Take as an example OxyContin, a high dose, slow-release oxycodone drug
intended for patients with chronic moderate to severe pain. When the
pill is crushed or chewed, destroying the slow-release feature, the
contents can be snorted or injected for a rush similar to that of heroin.

Contrary to media portrayals, the typical OxyContin addict does not
start out as a pain patient who fell unwittingly into a drug habit. In
2003, The Journal of Analytical Toxicology reported on deaths related
to oxycodone in 23 states over 29 months. In less than 2 percent of
the 919 oxycodone-related deaths was OxyContin the only drug - licit
or illicit - found at the autopsy. In 2002, the National Household
Survey on Drug Abuse found that among nonmedical OxyContin users, 98
percent had also used other addictive pain relievers for nonmedical
purposes and more than a fourth had used heroin.

Last August, the D.E.A. publicly acknowledged the need for a "principle
of balance" to address the necessity of access to pain medications and
the approaches to containing abuse, addiction and diversion. It
published "Prescription Pain Medications: Frequently Asked Questions
and Answers for Health Care Professionals and Law Enforcement
Personnel," which thoughtfully explained the concepts, and offered
clear descriptions of the circumstances under which the D.E.A. may
prosecute a doctor. Mysteriously, however, in early October the agency
pulled the document from the Web site, saying it had "misstatements."

The D.E.A. declined to elaborate on its reasons for pulling the
document. Some people have speculated that the agency was worried that
the information could be used to help clear physicians charged with
trafficking. Indeed, a lawyer for Dr. William Hurwitz, a pain
management specialist whose trial on drug trafficking charges is to
start Nov. 3, had already submitted the drug agency's document to the
Federal District Court in Alexandria, Va., as evidence in Dr.
Hurwitz's defense.

Certainly there are some doctors who abuse their power to prescribe
and deserve prosecution. But overzealous law enforcement takes a toll.

"We are unable to refer patients to doctors who will treat pain, if
only because once a name gets out there, patients understandably
flock, and then the doctor is targeted," said Siobhan Reynolds of Pain
Relief Network, a patient advocacy group based in New York. The
Association of American Physicians and Surgeons, based in Tucson and
dedicated to the concerns of private practitioners, has gone so far as
to warn doctors against managing chronic pain, lest they face of years
of harassment and legal fees, even prison. "If you do," the
association enjoins, "first discuss the risks with your family."

Scattered evidence confirms these impressions. A 1998 survey of more
than 1,300 physicians by the New York State Medical Society found that
60 percent were moderately or very concerned about the possibility of
being investigated by regulatory authorities for prescribing opiates
for noncancer pain.

A third said they prescribed lower quantities of pills and lower
dosages "frequently" because of the possibility of eliciting an
investigation. When asked how often they avoided prescribing a
preferred drug for noncancer pain, because doing so required
triplicate forms, half said "frequently."

But progress is being made. In 1998 the Federation of State Medical
Boards, which represents American licensing boards, published "Model
Guidelines for the Use of Controlled Substances for the Treatment of
Pain" to assure physicians that appropriate prescribing of opiate
painkillers would not lead to action against their licenses. Kansas
was among the first states to adopt the guidelines. Now, 22 of 70
American medical licensing authorities have done so.

Recently, the California Legislature passed a bill called "The Medical
Crimes: Investigations and Prosecutions." It requires that the state's
district attorneys association collaborate with "interested parties" on
protocols to investigate physicians.

Other states should follow suit. Better yet, they should require that
prosecutors first obtain declarations from qualified medical experts
as to the good faith of the physician in question before charges are
filed. It would go a long way toward making pain medicine what it
should be: a health care story, not a crime story.