Books Of The Times: 'Pain Killer'

BOON FOR PAIN SUFFERERS, AND THRILL SEEKERS

Pain Killer: A "Wonder" Drug's Trail Of Addiction And Death By Barry Meier,
323 pages. Rodale. $24.95

In the 1860's a new drug-delivery system, the hypodermic syringe, was
perfected. An injection of a small amount of morphine was found to produce
the same effect as a larger dose by mouth. Physicians assumed, therefore,
that hypodermic injections offered more protection against addiction.

Patients with chronic but not life-threatening pain, say osteoarthritis,
were provided with morphine and a syringe and told to inject themselves
when there was pain.

It took some years to appreciate the mistake, but the sad outcome was that
the hypodermic syringe not only did not protect from addiction, but it also
facilitated it. By 1920 the president of the American Medical Association,
Dr. Alexander Lambert of Cornell, somberly stated that "nearly 80 percent
of the morphine addicts have acquired the habit from legitimate medication"
provided by physicians.

During the 1920's the fear of prescribing addictive medicine permeated
American medical practice. Pain medication had to be doled out with great
care and parsimony. Inadequate pain relief characterized the life of some
cancer sufferers as well as postoperative patients. In the 1960's a
movement to bring adequate pain relief attracted both researchers and
practitioners.

This brings us to the years covered by "Pain Killer," an outgrowth of Barry
Meier's reports for The New York Times on OxyContin misuse. His fascinating
account of OxyContin's story has echoes of the hypodermic syringe episode
in the 19th century. OxyContin was initially marketed as less addicting
than other opioids because of a special mechanism that made the tablet
release the active ingredient slowly, a characteristic, it was assumed,
that would make OxyContin unattractive to misusers who wanted a big jolt.

This assumption was a big mistake. Recreational users discovered that
merely chewing the pill would release all of the active ingredient, and
produce a powerful high.

Mr. Meier specifically takes aim at the company that makes OxyContin,
Purdue Pharma of Stamford, Conn. He suggests that it was slow to address
reports of OxyContin's misuse because the drug brings in revenue of about
a=\ billion dollars annually. The Food and Drug Administration also comes
in for strong criticism for permitting the early marketing of OxyContin as
a relatively nonaddicting pain medication.

OxyContin entered the market in 1996 and quickly found favor as an
excellent pain medication for cancer patients. Up to 12 hours of pain
relief allowed patients to get a night's rest rather than experience the
return of pain every three or four hours with shorter-acting medicines. If
the drug had remained limited to patients with the most severe pain, the
story would probably be different, but advocates for pain treatment
minimized the danger of addiction and recommenced prescribing OxyContin for
milder and chronic pains. Mr. Meier cites other physicians, who said the
drug was being marketed too broadly and uncritically for such a powerful
anodyne.

Respected pain authorities estimated that OxyContin's addiction rate among
those in pain could be a mere 1 percent, perhaps less. The low figure came
from postoperative hospital patients, not from out-patients on long-term
opioid therapy. No studies on prolonged treatment with OxyContin had been
conducted. Nevertheless, doctors acted as if OxyContin had solved the
difficult balancing act between offering pain relief and avoiding
addiction, and began prescribing it for many kinds of pain for which milder
pharmaceuticals would be much more appropriate.

Then the problems began. By early 2000 in the southwest corner of Virginia
and in four or five other areas of the country, an explosion of OxyContin
misuse had spread among teenagers and their parents. With some doctors
prescribing the drug liberally and purveyors hawking it on the street,
families were being devastated and nonmedical users of OxyContin swamped
drug treatment programs. Doctors and other health workers appealed for help
and also wrote to Purdue Pharma telling the company of the multiple
problems that were occurring in their area.

Purdue Pharma officials said that the company first heard of these problems
in February 2000, although Mr. Meier says that information reached the
company a year earlier. When Purdue knew about the difficulties is relevant
to Mr. Meier's contention that the company dragged its feet in making
changes in the drug's description and indications. Because Purdue is
privately owned, access to its records is much more restricted than would
be the case with a publicly owned company.

The Food and Drug Administration, which was so cooperative with Purdue in
the early stages of its marketing, is now taking a closer look at its
responsibilities. Purdue agreed that after July 2001 it would no longer
state that OxyContin was less addictive because it was a slow-release
tablet. In fact, in 1998 The Journal of the Canadian Medical Association
reported that drug abusers actively sought slow-release pain medication. A
related editorial warned that assuming slow-release protected against
recreational use would lead to serious problems.

OxyContin's nonmedical use has now spread much more widely. The company has
changed its description of the drug and has mounted a major public
relations campaign to improve its image. Pain experts have apologized for
their uncritical advocacy of OxyContin. Yet their early assurances of the
99 percent safety from addiction may, to their regret, have set the stage
for a revival of extreme caution among doctors in providing relief to the
afflicted.

Long-term administration of pain remedies is facing mounting criticism. A
recent review article in The New England Journal of Medicine concluded that
"evidence now suggests that prolonged, high-dose opioid therapy may be
neither safe nor effective." Mr. Meier, in spite of difficulties obtaining
records and the considerable time required to scour isolated rural areas,
has given us a rare insight into interactions between government and the
pharmaceutical industry - and the extraordinary impact of their decisions
upon our lives.