DEA WITHDRAWS ITS SUPPORT OF GUIDELINES ON PAINKILLERS

The Drug Enforcement Administration has reversed its support for a set
of negotiated guidelines designed to end a controversy over the
arrests of hundreds of pain specialists who prescribed powerful
narcotics for their patients. The agency took the document off its Web
site earlier this month, less than two months after announcing it with
great fanfare.

In rescinding its endorsement, the DEA wrote on its Web site that the
31-page document "contained misstatements" and "was not approved as an
official statement of the agency." The agency declined to give any
more specifics, saying that it hoped to issue a statement "in one or
two weeks."

Worried doctors who had worked on crafting the "consensus" document --
written over the past year by DEA officials and prominent pain
management specialists -- criticized the agency's unannounced decision
to disavow it. They said they were given no explanation or told
whether the agency had changed its position on the contentious
question of when and how doctors can prescribe the popular painkillers
without risking prosecution.

Advocates for aggressive pain management said the DEA's decision
appears to have been triggered when defense lawyers tried to introduce
the guidelines in the upcoming drug-trafficking trial of William
Hurwitz, a McLean physician.

In late September, Hurwitz's defense team sought to introduce them as
evidence. Several weeks later, the DEA took the document off its Web
site and said it was not official policy.

Twelve days after that, U.S. Attorney Paul J. McNulty, who is
prosecuting Hurwitz, filed a motion in the case asking that the
guidelines be excluded as evidence, again saying that they do "not
have the force and effect of law."

"It seems pretty clear that they felt they had to try to get rid of
the guidelines because they supported so many parts of our case," said
Hurwitz's defense attorney, Patrick Hallinan. "If the Justice
Department followed the guidelines, there would be no reason to arrest
and charge Dr. Hurwitz." The case is scheduled for trial Nov. 3.

DEA spokesman Ed Childress said the agency intends to rework the
guidelines and publish them again. He said he could not comment on
whether the decision to remove them had anything to do with any legal
case.

The guidelines, which were published in August in the form of a
"Frequently Asked Questions" feature prominently displayed on the DEA
Web site, were described at the time as an effort to codify the
"balance" that both the DEA and the pain management community have
long said they are seeking.

The DEA has complained in the past that irresponsible, and possibly
criminal, doctors prescribed narcotic painkillers too frequently and
without enough care -- letting the valuable drugs get into the hands
of people who sell them, abuse them and sometimes are harmed by them.

But many pain specialists have watched with dismay as scores of
colleagues were arrested on criminal charges based on what many
believe was at worst negligent or sloppy prescribing practices. Many
of the cases triggered mandatory sentencing guidelines that can send
convicted drug dealers to prison for decades.

The introduction of long-lasting prescription opioids such as
OxyContin revolutionized the treatment of pain, which doctors say is
greatly under-treated in the United States.

Researchers say a small percentage of patients become addicted, but
most people in pain do not. However, OxyContin and other powerful
drugs became popular with drug abusers in the late 1990s, especially
in rural and southern areas, and it has been linked to numerous
hospitalizations and some deaths.

The consensus document was the product of more than a year of work by
Russell K. Portenoy, a leading pain expert with New York's Beth Israel
Medical Center, University of Wisconsin pain specialist David E.
Joranson, professionals involved in the care of dying patients, and
two top officials of the DEA.

When the guidelines were made public, DEA Administrator Karen P. Tandy
embraced them and said in a statement: "The medical and law
enforcement communities continue to work together to carefully balance
the needs of legitimate patients for pain medications against the
equally compelling need to protect the public from the risk of
addiction and even possible death from these medications. . . . The
DEA is committed to assisting the overwhelming majority of health care
providers who successfully strike that balance every day, as well as
the law enforcement officers investigating diversion and abuse of pain
medications."

Portenoy said the group worked closely with the DEA, responding to
many of its concerns and revising drafts many times to accommodate the
agency. Portenoy said agency officials were active in the entire
process, and he said he strongly believed that there had been
"complete buy-in from the upper echelon" of the DEA regarding the guidelines.

Since word went out the guidelines had been withdrawn, he has received
many calls and e-mails from worried and upset doctors, Portenoy said.

"There was a real feeling that we had made significant progress, but
now we have to wonder whether that progress is all gone," Portenoy
said. "If they don't fix whatever problems they might have and put the
document back up, that would speak very clearly that the goal of the
DEA is not to collaborate with the medical community or to reassure
doctors about the proper role and use of prescription opioids in pain
management."

The guidelines were also on many Web sites for pain clinics and
programs. The DEA called at least one of them, the Pain & Policy
Studies Group of the University of Wisconsin, and asked it to remove
the document.