DOCTORS, DRUG AGENCY AT ODDS ON PAIN RELIEF

An abrupt change in policy by the U.S. Drug Enforcement Administration
has upset University of Wisconsin pain experts, who fear the result
will be that patients won't get the pain relief they need.

In August, the DEA published guidelines on its Web site detailing a
statement about prescription pain medication that had been negotiated
by the drug enforcement agency, the Last Acts Partnership and the
University of Wisconsin-Madison Pain and Policy Studies Group.

That document reassured medical practitioners that they could
prescribe regulated narcotics, such as OxyContin and morphine-based
painkillers, without being arrested.

The August FAQ (a response to frequently asked questions) stated: "The
number of patients in a practice who receive opioids, the number of
tablets prescribed for each patient, and the duration of therapy with
these drugs do not, by themselves, indicate a problem, and they should
not be used as the sole basis for an investigation by regulators or
law enforcement."

In a new statement in November that rejected the August statement, the
DEA said, "In fact, each of the foregoing factors - though not
necessarily determinative - may indeed be indicative of diversion."

The agency additionally said that the August FAQ understated the
degree of caution that a physician must exercise to minimize the
likelihood of diversion when dispensing controlled substances to known
or suspected addicts.

"This came as a great surprise for several reasons," said David
Joranson, director of the Pain and Policy Studies Group in Madison,
who learned about the impending change in October when the DEA asked
the pain policy group to remove the FAQ from its Web site and said a
new statement would be forthcoming.

"It made us question their commitment to achieving a balanced policy
around drug control and pain management," Joranson said. "If DEA is
going to reverse a previous interpretation of law and regulations,
there should be an opportunity to comment on the change in policy."

He also noted that the DEA had approved the previous
document.

The November statement also warned that that the use of narcotics and
other prescription controlled substances is increasing in the United
States, and that 31 million Americans age 12 or older have engaged in
illicit (non-medical) use of pain relievers during their lifetimes.

"The August 2004 FAQ was not an official statement of the agency" and
contained misstatements, the DEA stated in November, noting that it
was not published in the Federal Register, as the November statement
was.

Ed Childress, acting chief of public affairs for the DEA, said
Thursday in a phone interview from Washington, D.C., that the change
was made because "statements were identified as being misstatements of
law."

Childress would not comment on why the DEA approved the August
statement if it contained inaccuracies.

The August statement, from 21 health organizations and the DEA, was
based on a "thoughtful dialogue" over many months, Joranson said. The
DEA had wanted to explore development of a policy statement developed
by the pain and medical community that they could endorse.

"It was a positively worded statement indicating that preventing drug
abuse is an important societal goal, but it should not hinder patients
from getting the care they deserve," Joranson said. "There were many
reviews and 20 drafts."

A disclaimer made it clear that this was not legal advice for any
cases and not guidelines and not a standard of care, Joranson said.
"It was an FAQ, an effort to educate law enforcement and health care
personnel. It was aimed to help both do their jobs."

However, after the DEA removed the document from its Web site, a judge
in the case of William E. Hurwitz, a pain doctor who was on trial in
Virginia for alleged drug trafficking, ruled that the August statement
could be excluded as evidence, according to the Washington Post.

Congress never intended the Controlled Substances Act to interfere
with medical treatment, according to Joranson.

"The really interesting thing is what happens next," he said. "The
pain community needs to remain committed to re-engagement with the DEA
to work at these issues. The DEA should figure out how to speak with
one voice and issue a more balanced statement.

"Some policy issues may need to be addressed by revisiting the
Controlled Substances Act. It will probably be early next year before
we see what the next steps are."