Why DEA Enforcement Is Misguided
July 30, 2001
On June 4, 2001 Dr. Eric Chevlen wrote an article published in The
Weekly Standard that clearly spelled out the basic reasons why recent
efforts of the Drug Enforcement Agency (DEA) to radically control the
distribution of OxyContin is misguided. I've organized the basic
information from Dr. Chevlin's article into an organized briefing
Putting OxyContin Abuse Into
Let's start by putting the the problem of OxyContin abuse into
persective. Last year (the year 2000):
200 people died from the abuse of oxycodone, the active ingredient of
OxyContin in the year 2000.
Virtually all of these oxycodone deaths are due to purposeful abuse of the
There have been no documented deaths from the use of this drug as
Statistically the number of deaths (200 in one year) are incredibly small
considering the number of chronic pain patients using narcotic pain
medications (about 10 million).
Limiting patient access to OxyContin because of these rare tragedies is
like limiting access to rope because some people hang
16,000 Americans died from using non-steroidal anti-inflammatory drugs
such as Advil and Aleve for treating their arthritis.
Codeine is five times more likely to be mentioned by medical examiners as
contributing to death as oxycodone.
The misuse of acetaminophen (Tylenol) is over three times as likely to
result in an emergency room visit as is purposeful misuse of
oxycodone. (Source: Drug Abuse Warning Network)
An American is twice as likely to be struck by lightning as he or she is
to die from abusing OxyContin.
The Drug Enforcement Agency (DEA)
Mobilizes For Action
With terrible shortsightedness, federal bureaucrats at the Drug
Enforcement Agency (DEA) have chosen to take extremely punitive legal
action to address the problem of the 200 deaths related to
oxycodone. These legal actions are part of a high-profile campaign
against doctors and pharmacists "responsible" for the abuse of
OxyContin. They are also placing pressure on the drug manufacturer
to change how it packages and distributes the medication.
Under this punitive drug enforcement policy doctors who prescribe and pharmacists
who distribute OxyContin can be charged with drug trafficking if, in the
DEA's opinion, the prescription and distribution of the medication
represented prescription drug abuse. These threats of legal action
against doctors and pharmacists are creating an atmosphere of fear which
causing many doctors to provide inadequate or ineffective medication for
chronic pain patients who need and can benefit from the
The inevitable consequence of this campaign will
be less pain relief for those who need it, and possibly a higher death
toll from overuse of substitute painkillers.
This History of OxyContin
OxyContin was introduced in the United States in 1995 by Purdue
Pharma, a privately held pharmaceutical company based in Stamford,
Connecticut. Its active ingredient, oxycodone, had been in use for
over 60 years. But the innovative delivery system of this ingredient was
the key to the new drug's clinical success. For several decades, pain
specialists have recognized that opioids (the class of drugs that used to
be called narcotics) are safe and effective in relieving the severe pain
of cancer and other chronic conditions. The key to their successful use is
having a steady amount in the bloodstream. It seems obvious now, but it
was an insight then: If pain is present all the time, pain medication
should also be present in the bloodstream constantly. The drug should not
be taken just "as needed."
The problem that Purdue overcame is that morphine, oxycodone, and other
opioids relieve pain for only a few hours. A patient would have to take
his medication every four hours—even setting a clock to get up at night
for a dose. Purdue developed systems by which a medication tablet would
deliver its contents continuously (hence the name) over 12 hours. The
company's first such analgesic was MS-Contin. Although clinically
effective, the drug did not reach its full commercial potential in large
part because of the stigma associated with its active ingredient,
morphine. OxyContin, Purdue's second continuous-release opioid,
contained oxycodone, a drug whose pharmacologic effect is very similar to
that of morphine, but one that, at least in those days, did not carry the
negative associations of morphine. OxyContin proved to be a billion
dollar home run for Purdue. Its success was due to the confluence of
Early in the promotion of the product, Purdue recognized that
physicians needed to know about about new advances in pain management and
about how to appropriately prescribe and manage pain medications.
Most doctors learn little or nothing about pain, chronic pain management,
and addiction in medical school. Purdue beefed up its existing
program of physician education. Their goal was to get doctors up to date,
not just about opioids, but about all aspects of pain management.
Doctors began to take the pain complaints of their patients seriously, and
to treat them effectively. The program was successful in all
areas. More doctors became aware of the legitimate needs of pain
patients for appropriate medication. Pain patients began getting the
treatment which provided the much needed relief from pain, and
Purdue added a best selling pain medication to their inventory.
First, the drug was recognized by the FDA recognized to be safe and
effective for the management of moderate to severe chronic pain.
It was introduced at a time when doctors were becoming more aware of the
scandalous under treatment of chronic pain, and learning that when
properly used, opioids carried little risk of addiction.
Purdue marketed the drug brilliantly.
The Drug Abuse Problems Associated
With the success of OxyContin have come some predictable problems. As
OxyContin has achieved a larger share of the analgesic marketplace, its
share in the drug-abuse marketplace has also risen.
Narcotic Addicts were under pressure to find a substitute to
heroine. This was because the DEA had stepped up their efforts to
get heroine off the streets without providing any treatment
alternatives. narcotic addicts learned that by grinding OxyContin
tablets and snorting or injecting them, they could overcome the slow
delivery system that Purdue scientists had worked so hard to create. And
since OxyContin is a drug of known quality and purity, it has become
popular among addicts. Lurid stories in Time, Newsweek, and the New
York Times have only served to increase the interest of customers in the
The Practice of Medicine & Drug
Purdue is thus in a difficult position. Its major profit center is a
drug whose distribution is strictly controlled by federal law. So while it
is arguable whether the DEA has the authority to disrupt the marketing of
a legal drug, Purdue is hardly in a position to criticize a wrongheaded
Indeed, Purdue is probably more eager than the DEA to curtail abuse and
diversion of its number one product. For the company, the misuse of
OxyContin is not a source of profit but a nightmare of the first order.
The abuse cases are relatively rare but have a huge and disproportionate
impact in deterring doctors from prescribing the medication for patients
who could truly benefit from it.
Purdue has thus rolled out its own 10-point plan to reduce prescription
drug abuse. Among other things, the company has modified its educational
programs to include more training for doctors and pharmacists in
distinguishing genuine pain patients from scam artists. At the same time,
in a meeting it sought with the DEA, Purdue and the agency agreed that
OxyContin should only be prescribed according to the FDA-approved
indication and should only be prescribed by physicians knowledgeable in
the use of opioids to treat pain.
On a formal level, this agreement is not unlike an agreement between
two countries in conflict that merely serves to paper over the stark
differences between them. And the differences are substantial.
Medical Regulation vs. Drug
A spokesperson for the DEA says the agency is not satisfied with this
agreement and has "suggested" that Purdue market the drug only
to pain specialists, and that it be distributed only by a limited number
Anyone who cares about the relief of suffering should hope that the
company resists that suggestion. The DEA stance is misconceived in several
OxyContin abuse cases — admittedly rising in number but still
relatively small — are clearly less of a social problem than those
associated with several other drugs.
Why OxyContin Has been Targeted
OxyContin has been targeted by the DEA for inordinate attention for
OxyContin is the most successful and prominent pain-control drug in the
The success of OxyContin has has legitimized the concept of ongoing opioid
therapy for a larger class of patients — those with moderate to severe
chronic pain from non-malignant causes, not just cancer patients. This
idea still encounters resistance from some doctors and public officials.
DEA Opposition To Pain Medication
Unfortunately, despite DEA protestations to the contrary, sharply
limited access to pain relief is the completely predictable result of the
agency's plan. There are an estimated 30-50 million Americans who
live in chronic pain. Only one in four of them is now receiving
proper treatment. For many people in pain, opioids are the safest
and most effective (or only effective) form of relief.
There are only about 3,000 pain specialists in the country, and many
parts of the country have none at all. These few specialists could
no more take care of all the pain patients who need opioids than a few
thousand endocrinologists could take care of all the diabetics who need
While they may rely on occasional specialist consultation, primary care
physicians must treat pain patients or they simply will not be treated.
Similarly, reducing the number of pharmacies that stock OxyContin will do
little more than inconvenience patients whose ability to travel is already
restricted by their illness.
Even in the absence of DEA action, the OxyContin frisson has already
resulted in a diminished quality of life for pain patients. Consider
Purdue's May 11 decision to "temporarily suspend" shipment of
the 160 mg tablets. This is the strongest dose form of the drug, and
accounts for less than 1 percent of total sales. Many of the people taking
this high dose of opioid are end-stage cancer patients. Now their final
months will be burdened by having to swallow twice as many pills (the 80
mg tablets are still available). For many dying patients, the very act of
swallowing medication is painfully difficult.
Purdue acknowledges that there have been few reports of diversion of
the 160 mg tablets, and the DEA has no idea which dose form is most likely
to be abused. It is hard to see the benefit of such a policy. And
for some patients, the problem will be worse than inconvenience. In
many states, Medicaid rules limit the filling of opioid prescriptions to a
certain number of pills, not a certain total dose. So cancer pain
patients who can't afford to pay out of pocket for the expensive drugs
will find that they'll simply have to get by on a lower dose. In other
words, they'll just have to suffer.
Terrence Woodworth, deputy director of the DEA's office of Diversion
Control, was quoted in a New York Times report as saying that the agency
believes the drug has "been frequently prescribed by doctors who
could have recommended less powerful drugs before turning to
What drugs could the DEA have in mind? Could they mean the
non-steroidal anti-inflammatory drugs, which are of limited benefit in
treating chronic pain, but add a significant risk of stomach bleeding and
kidney damage? Or perhaps they mean tablets such as Vicodin, which
combine the opioid hydrocodone with acetaminophen. These are less potent
in relieving pain than most strengths of OxyContin, and their
acetaminophen ingredient carries a risk of serious liver damage.
Even if the DEA sat in on every office visit of every patient receiving
a prescription for OxyContin, it would still not be able to say what
percentage of the prescriptions are medically necessary. The
DEA, fundamentally not a medical but a police agency, has no such
But power it does have. Even if it cannot usurp the FDA in controlling
how Purdue markets and distributes the drug, it can certainly affect the
prescribing of it. A few well-publicized intimidating visits to
doctors who prescribe OxyContin will have a profound chilling effect on
the willingness of most doctors to prescribe the drug. Indeed, the
media circus surrounding the drug, and the statements of the DEA, have
already had that effect.
The full adverse impact will not be limited to OxyContin and the
patients who use it. Intimidating doctors from prescribing one
opioid will limit their willingness to prescribe any. Moreover,
there are several new sustained-release opioids already or soon to be
submitted for FDA approval. There has never been, and likely never will
be, any opioid analgesic on the market that cannot be abused or diverted
by a motivated drug addict.
Dr. Cynthia McCormick, head of the FDA branch that approves opioid
analgesics, is reportedly embarrassed by the abuse now attributed to a
drug her agency approved. The bureaucratically safe solution to her
problem is to just say no, or to set the standard of approval
unrealistically high. The losers, as always, will be people in pain.
In light of this, many in the pain management field find it ominous
that Dr. McCormick recently scheduled a rare meeting of the Anesthetic and
Life Support Drugs Advisory Committee, only to abruptly cancel it after
many concerned clinicians got wind of it. The committee's agenda was
to include "concerns regarding the abuse potential, diversion, and
increasing incidence of addiction to opiate analgesics, especially to the
modified-release opiate analgesics." Nor is it very comforting
to realize that the members of the advisory committee are selected by the
FDA itself. Keen readers of the Federal Register will also note that
within a week of announcing the committee meeting, the FDA announced that
it is prepared to appoint five more committee members immediately, and
four more within the next year.
While abuse and diversion of OxyContin is clearly a problem that should
not be neglected, the response of the Drug Enforcement Administration is
both disproportionate and counterproductive. Similar action by the FDA to
limit legitimate use of this or other opioids puts at risk the
long-overdue progress that has recently been made in the management of
chronic pain. Perhaps we cannot avoid death and taxes, but must we live in