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 September.
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.
