Last week, DRCNet reported briefly on the Drug Enforcement Administration's (DEA) Diversion Control Program's sudden decision to remove a list of questions and answers about proper pain management care from its web site (http://stopthedrugwar.org/chronicle/357/deapain.shtml). We vowed then to dig deeper, but with the DEA uncommunicative, a week later more questions remain than answers about the mysterious case of the vanishing "PRESCRIPTION PAIN MEDICATIONS: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement Personnel."
In recent years, hundreds of doctors have been prosecuted by state or federal authorities or sanctioned by state medical control boards for prescribing practices that are within accepted medical practice but are deemed "suspicious" by the DEA or local law enforcement. This crackdown on "drug diversion" promises to grow even more intense as the White House takes aim at prescription drug abuse, but it also comes at a time when nearly 50 million Americans are suffering from chronic pain.
With great hoopla, the DEA unveiled the pain FAQ two months ago. In an August 11 press release trumpeting its publication, DEA administrator Karen Tandy hailed it as a model of collaboration and balance. "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," said Tandy. "We look forward to continuing this successful partnership. 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."
But October 6, the agency was singing a different tune. "The document contained misstatements and has therefore been removed from the DEA web site," read a terse notice posted that day. "DEA wishes to emphasize that the document was not approved as an official statement of the agency and did not and does not have the force and effect of law."
When DRCNet contacted the DEA this week seeking an explanation, there was none. When asked what the misstatements were and why the DEA now says the pain FAQ was not approved as an official statement after it posted it on its web site, DEA spokesman William Grant replied only that "they are coming up with some new changes, hopefully within the next week or so." Any further information would have to be requested via e-mail. DRCNet has done that. We are awaiting a reply.
The consensus pain FAQ was produced by experts from the DEA, the University of Wisconsin Pain and Policy Studies Group, and Last Acts (http://www.lastactspartners.org), a national coalition of consumer and professional organizations working to improve end-of-life care through the use of palliative medicine and pain management techniques. Last Acts and the DEA signed an earlier consensus statement stressing the need for "balance" between law enforcement's demand to prevent drug abuse and diversion and the medical imperative to treat the sick in 2001.
Last Acts did not return DRCNet calls for more information, but the Wisconsin Pain and Policy Studies Group pronounced itself mystified by the sudden disappearance. "This was the product of months of effort," said Aaron Gilson, the group's assistant director. "Pain management experts and addiction medicine experts and pharmacologists and pharmacists wrote the sections on pain, while the DEA wrote the sections on the regulatory aspect. Then we switched and each group commented on the other side. There was a strong consensus about the accuracy of the messages contained in that document," Gilson told DRCNet.
As for yanking the pain FAQ, Gilson could only say, "We know nothing more than what the DEA has said. The message says the document contains misstatements, but we don't know what they are. The DEA did not tell us this was coming."
But despite the sudden, unannounced move undoing months of work on the pain FAQ, Gilson held out hope that academics could continue to work with the DEA on addressing the crisis in pain management. "It is important to realize that their statement makes it clear that they aren't backing away from supporting appropriate use for pain relief, but just evaluating this document," he said.
Other observers are less charitable toward the DEA -- and the academics who have tried to work with the agency. "Perhaps when they see their good faith efforts turning to dust like this, academic medicine will start to realize it has been used by the DEA," said Siobhan Reynolds, executive director of the Pain Relief Network (http://www.painreliefnetwork.org), an advocacy group for pain patients and the doctors who seek to treat them. "Any doctor or scientist who would continue to work with the DEA after the doctors charged and dragged through the mud, the harassment of patients, and now this -- they do not represent the interests of patients in this country. At some point, these people have to wake up and smell the coffee."
The University of Wisconsin Pain Policy Group's Gilson disagreed that working with DEA was a waste of time. He argued the agency was indeed involved in a good faith effort to resolve concerns about drug diversion while at the same time protecting the rights of patients to adequate pain treatment. "It was the DEA who approached us about this issue," he said. "They were receiving reports that physicians were afraid of being investigated or prosecuted by the DEA, and they wanted to create a document that would help both health care professionals and law enforcement understand what is the appropriate use of these drugs."
Gilson said his organization would continue to work under the assumption that the removal of the FAQ was an "anomaly" and DEA sincerely wants to provide guidance for physicians to help them avoid prosecution. Still, said Gilson, he understood why some are skeptical. "There is criticism coming from doctors who have been investigated or prosecuted, and some of those prosecutions were ill-founded and without any probable cause. That deserves an angry response," he said. That is why the group's work with the DEA is so important, he added. "This is why we saw the pain FAQ as such an important resource. If both law enforcement and the health field begin to understand the principles of pain management, we see that as a win-win. Enforcers will understand what is behind what appears to be suspicious prescribing, and we will see less of those unsupported cases."
The vanishing pain FAQ illustrates that the DEA doesn't really know what it is doing, said Reynolds. "This just shows that the DEA doesn't even know what its own expectations of physicians are," she said. "If the DEA doesn't know, how in the world are doctors supposed to know? Look, the problem I had with the FAQ was that these are medical, not criminal, issues, and it was created in the context of the criminal law. But its content clearly expressed the ambiguity and difficulty of pain treatment, especially with people who may be addicted or criminals. The FAQ made clear that just because a doctor treats such a person, it doesn't mean he is a criminal. And now that is gone."
University of North Florida political scientist Dr. Ronald Libby, who is penning a book on the clash between the imperatives of law enforcement and those of medicine, suggested more sinister motives for the removal of the pain FAQ. "There is speculation that this is tied to some high-profile cases being tried soon," Libby said, pointing to the looming prosecutions of well-known Northern Virginia pain specialist Dr. William Hurwitz and the retrial of Southwest Virginia pain specialist Dr. Cecil Knox.
"In the pain FAQ, there is a section that basically says prosecutors need to establish criminal intent by doctors," Libby told DRCNet. "But prosecutors can't do that in these cases. Instead, they work backward from the patients. They may be legitimate pain patients, but they might also sell drugs. The DEA and prosecutors will try to work backward, to infer the guilt of the doctor from the behavior of the patients, but that is not the same as proving criminal intent," Libby argued.
"By removing the pain FAQ, the DEA was basically responding to the needs of prosecutors in these cases," Libby said. "This appears to be a direct response to the defense position taken in the Hurwitz case. Hurwitz' attorney, Eli Stutsman, specifically referenced that FAQ in his brief, and now it's gone. This should be an embarrassment to the DEA and the prosecutors."
If they have any shame, perhaps. But whether or not the feds are embarrassed, Libby called foul on the removal of the FAQ. "It is just plain duplicitous," he said. "It basically lowers the bar for getting criminal convictions by holding the doctor responsible for anything his patients do, and it does so in a very timely fashion for prosecutors."
"The DEA is an agency out of control," said Reynolds, "and they've now gotten themselves into a terrible crisis. They've been essentially running illegal prosecutions and regulating medicine through intimidation. This is all an artifact of a century-long power grab by the enforcers into the regulation of medicine. While we have been in a showdown between the DEA and medicine in recent years, medicine keeps losing because the other guys have the guns. But the DEA's room for maneuver is getting tighter and tighter."
There need to be congressional hearings on the DEA, said Reynolds -- that's right, said Libby. "We haven't had DEA hearings in more than 10 years," he said. "It is past time to bring their activities to public attention and hold them accountable for what they have been doing."