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 sometimes good, aggressive treatment or, at worst, negligent 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.