HTTP/1.0 200 OK Content-Type: text/html New DEA Statement Has Pain Doctors More Fearful
Pubdate: Tue, 30 Nov 2004
Source: Washington Post (DC)
Copyright: 2004 The Washington Post Company
Author: Marc Kaufman, Washington Post Staff Writer
Bookmark: (Chronic Pain)
Bookmark: (Oxycontin/Oxycodone)
Bookmark: (Treatment)


Agency Reneges On Guidelines Worked Out For Narcotics

An extensive effort to ease tensions between physicians who specialize in 
treating pain and the Drug Enforcement Administration over the use of 
morphine-based painkillers has backfired -- leaving many pain doctors and 
patients more fearful than before that they could be arrested for 
practicing what they consider good medicine.

The DEA triggered the new impasse this month when it published a statement 
clarifying its position on a number of issues central to pain medicine. The 
document discusses when a doctor is at risk of being investigated for 
alleged prescription drug diversion, whether patients with known drug 
problems can ever be prescribed narcotic painkillers and whether doctors 
can give patients prescriptions to be filled on a future date.

On all these issues, the new DEA position is at odds with a set of 
guidelines negotiated over several years by DEA officials and a group of 
leading pain-management experts. Those guidelines were posted on the 
agency's Web site in August as part of an effort to reassure doctors who 
properly prescribe narcotics, but several weeks later the document was 
abruptly removed and described by the agency as inaccurate and unofficial.

Pain-management experts have responded to the new notice with dismay, 
saying its provisions may well result in the denial of pain relief to 
millions of sufferers.

Howard A. Heit, a pain and addiction doctor in Fairfax County, said 
yesterday that "over 90 percent" of patients and doctors could face 
investigation under the new guidelines.

"This approach is chilling to me, and I work with the DEA all the time," 
Heit said in an interview. "General practitioners will see this and say, 
'Why should I prescribe opioids and risk getting into trouble?' "

In a letter to the DEA last week, David E. Joranson, a University of 
Wisconsin pain expert who led the negotiations with the agency, accused it 
of unilaterally changing important and long-standing practices. Some of the 
changes, the letter said, leave doctors confused about how they should 
prescribe painkillers and "are likely to interfere in medical practice and 
pain management."

In explaining why it took down the guidelines in early October, the DEA 
said the document contained misinformation that would soon be corrected. 
The reworked version published Nov. 16 in the Federal Register toughened 
the agency's position on some of the most sensitive issues.

The new DEA statement said, for instance, that the earlier guidelines were 
incorrect in saying that the number of patients in a doctor's practice 
receiving prescription narcotics, the number of tablets they receive, and 
how long their therapy lasts "do not, by themselves, indicate a problem."

In its November statement, the DEA said all three of those factors "may 
indeed be indicative of diversion." In addition, the statement said, "it is 
a longstanding legal principle that the Government 'can investigate merely 
on suspicion that the law is being violated, or even just because it wants 
assurances that it is not.' "

The August guidelines also said it was legitimate for doctors to give 
patients a number of prescriptions for an opioid painkiller with 
instructions that they be filled on future dates. Because some controlled 
drugs can legally be dispensed only in small quantities, this practice 
allows patients to avoid returning weekly or biweekly for another 
prescription. It is frequently done by pain-management physicians, and 
Russell Portenoy, a top pain specialist at Beth Israel Medical Center in 
New York, said it has been discussed and recommended in medical journals 
and doctor training sessions.

But in the Federal Register, the DEA said that practice is clearly illegal.

"We're seeing more of an emphasis on law enforcement and less on the 
legitimate use of prescription narcotics," said Portenoy, who also took 
part in negotiations with the DEA. He said the agency has changed the "tone 
of the dialogue in a way that is very worrisome."

The issue of prescription narcotic use -- and abuse -- has become a thorny 
one as illegal diversion has increased at the same time that the usefulness 
of prescription narcotics in pain treatment has become better understood.

The DEA has arrested hundreds of doctors and pharmacists in recent years on 
painkiller-related drug charges, including prominent McLean pain doctor 
William E. Hurwitz, who is now on trial in Alexandria. Many members of 
Congress have been demanding action to stop the illegal use of powerful 
prescription opioids such as OxyContin and Dilaudid, which have been 
implicated in the deaths of many illicit users.

Sen. Jeff Sessions (R-Ala.) captured the mood when he introduced a bill 
this month to help states prevent prescription drug abuse. "Over the past 
10 years," he said, "the abuse and diversion of prescription drugs has 
grown from a regional crisis to a national epidemic." Sen. Richard J. 
Durbin (D-Ill.) co-sponsored the legislation.

Many in the pain-management field, however, say narcotic painkillers are 
often the best -- or only -- way to relieve chronic pain. But fear of a DEA 
investigation, pain specialists say, is keeping some worried physicians 
from writing medically appropriate prescriptions, and patients are 
suffering needlessly as a result.

Working with the DEA since 2000, the Pain & Policy Studies Group at the 
University of Wisconsin at Madison Medical School and several other 
organizations focused on end-of-life issues sought to create a generally 
accepted and "balanced" approach to prescription narcotic use and control. 
It was these groups, working with representatives of the DEA, that hammered 
out the guidelines, presented in a frequently-asked-questions (FAQ) format, 
that were posted on the DEA Web site this summer.

The DEA declined to comment on the letter from the Pain & Policy group or 
the criticism of its new notice in the Federal Register. Regarding the 
original FAQ document, spokesman Ed Childress said "it was meant to be a 
general guideline, not an official statement of the agency."

In the Federal Register statement, the DEA did acknowledge that chronic 
pain is a serious problem for many Americans and said most doctors 
prescribe controlled painkillers legitimately. The agency said it would 
address that aspect in more detail in the future.

"The document will be aimed at providing guidance and reassurance to 
physicians who engage in legitimate pain treatment while deterring the 
unlawful conduct of a small number of physicians and other DEA registrants 
who exploit the term 'pain treatment' as a pretext to engage in 
prescription drug trafficking," the statement said.

What concerns experts such as Joranson and Portenoy is that they thought 
the collaborative process leading up to the issuing of the FAQ guidelines 
had done precisely that.

Advocates for aggressive pain management said the DEA's abrupt turnaround 
appeared to have been triggered when defense lawyers tried to introduce the 
earlier pain guidelines in the trial of Hurwitz, the McLean doctor, in late 

The DEA took the document off its Web site soon after. About two weeks 
later, U.S. Attorney Paul J. McNulty, who is prosecuting Hurwitz, filed a 
motion asking that the guidelines be excluded as evidence, saying that they 
do "not have the force and effect of law." U.S. District Judge Leonard D. 
Wexler ruled in favor of the government.
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