OXYCONTIN'S DANGERS OUTWEIGH ITS BENEFITS

Last week, in response to mounting problems with the painkiller OxyContin,
I filed legislation in Congress to withdraw its Food and Drug
Administration approval and remove it from the market. While the bill
received a robust response from both supporters and opponents, there
remains considerable misunderstanding as to the nature of the OxyContin threat.

This product is one of the most addictive substances to be sold legally in
the United States. It is twice as addictive as morphine. The premise of my
legislation is that the drug is so inherently addictive that it is unsafe
for the general population to whom it is being marketed and prescribed.

As originally approved, OxyContin was supposed to be for end-stage cancer
patients and others with severe and escalating pain - those people for whom
the drug's addictive propensity was balanced by the extreme circumstances
of the patient. Because of its overpowering addiction rate, the U.S. Drug
Enforcement Agency described OxyContin as a painkiller of last resort.

However, as the Government Accountability Office has reported, Purdue
Pharma has aggressively expanded the market for OxyContin to include
patients who suffer from mild to moderate and intermittent pain related to
broken bones, dental discomfort and lower back pain. In stunning testimony,
a former district manager for Purdue Pharma in West Virginia disclosed that
the company instructed sales reps to tell doctors "it is 'virtually'
non-addicting."

As a result of Purdue Pharma's reckless marketing of OxyContin, the number
of prescriptions exploded, and by 2003 nearly half of all OxyContin
prescriptions were being written by primary care doctors, not pain
management specialists.

The FDA issued three warning letters to Purdue Pharma about its unlawful
marketing representations in May 2000, August 2001 and January 2003. In the
last letter, Thomas Abrams, director of the FDA Division of Drug Marketing,
Advertising and Communications, stated: "Your journal advertisements are
misleading because they make prominent claims of effectiveness for pain
relief, but omit from the body of advertisements crucial facts related to
the serious, potentially fatal safety risks associated with the risks of
OxyContin to be abused, and the limitations on its appropriate indicated use."

Meanwhile, it appears the incidence of OxyContin addiction is going off the
charts. Fifty-six percent of all OxyContin addictions have occurred in
patients who were legally prescribed the drug.

My legislation would be unnecessary if manufacturer Purdue Pharma, which
derives 80 percent of its profit from this one drug, took mitigating steps
without congressional pressure.

It could, for instance, redesign the drug with a lower addiction rate and
build in precautions to prevent OxyContin's time-release feature from being
overridden and abused. The manufacturer could provide consistent label
warnings as to OxyContin's addictive characteristics, and cease and desist
its aggressive marketing of the drug by salespeople and "detailers" to
primary care physicians. By restricting the distribution chain to
specialists at pain clinics and hospitals, and by limiting the conditions
for which OxyContin may be prescribed, the dangers could be greatly diminished.

Finally, Purdue Pharma should become more engaged in research and
rehabilitation efforts aimed at treating those with OxyContin addictions.
But until we see meaningful steps to make OxyContin safer, I have no other
option than to seek its removal.

U.S. Rep. Stephen Lynch of South Boston is the ranking Democrat on the
House subcommittee on regulatory affairs.