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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.
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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.
http://www.nytimes.com
GRAPHIC: Photo: Barry Meier (Photo by Fred R. Conrad/The New York
Times)
LOAD-DATE: December 17, 2003
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Alexander DeLuca, M.D.