Feature: The DEA's New Proposed Policy Statement on Pain Prescribing -- What Does It Mean?

When the Drug Enforcement Administration (DEA) issued a new policy statement on prescribing controlled substances for patients suffering from chronic pain last week, it sought to redress the rising chorus of concern and complaints from health care workers and patients alike that its tough stance toward physicians prescribing opioid pain medications was resulting in a crisis in care for chronic pain patients. But if the activists and experts Drug War Chronicle talked to this week are any indication, the DEA's job in reassuring the pain care community is far from done.

The move comes after years of increasing prosecutions of physicians like Dr. William Hurwitz, a leading pain care practitioner in Virginia, who was convicted of being a drug dealer over his prescribing practices. (That conviction was recently overturned on appeal.) It also comes two years after the DEA shocked and dismayed the pain care community, including many academic pain specialists who had worked with the agency, by first posting and then quickly removing a series of "frequently asked questions" designed to assist physicians in staying within the good graces of the law. It is now commonly suspected in the academic pain community that the DEA pulled the pain FAQ at the request of the Justice Department because it would have aided Hurwitz's defense in his November 2004 trial, but the Justice Department hasn't confirmed that.

In a September 6 press release announcing the agency would loosen regulations on prescribing Schedule II drugs, DEA administrator Karen Tandy also unveiled the new policy statement on prescribing. "We listened to the comments of more than 600 physicians, pharmacists, nurses, patients, and advocates for pain treatment, and studied their concerns carefully. Today's policy statement is the result of that collaboration. The policy statement reiterates the DEA's commitment to striking the proper balance to ensure that people who need pain relief get it, and those who abuse it, don't," said Tandy.

The policy statement outlines DEA's vision of how doctors can prescribe powerful pain medications, such as Oxycontin or fentanyl, without ending up being arrested and called a "drug dealer" by federal prosecutors intent on throwing them in prison for years. Such drugs must only be prescribed for a "legitimate medical purpose," the DEA said.

"We believe that the statement and proposed rule will help the medical professional ensure that only patients who need medication for pain relief get it. The statement reflects an awareness of patients' needs as well as the importance of preventing any illegal diversion of prescription drugs," Tandy continued. "Today's policy statement reaffirms that DEA wants doctors to treat pain as is appropriate under accepted medical community standards. Physicians acting in accordance with accepted medical practice should be confident that they will not be criminally charged for prescribing all appropriate pain medications," Tandy concluded.

Not everyone was buying what Tandy was selling, though. "This new policy statement is mere window dressing," said Dr. Frank Fisher, a California physician who underwent a years-long legal ordeal after being accused of murdering his patients through overprescribing. He was ultimately acquitted on all criminal charges, but he was ruined financially and professionally. "The problem is that physicians are intimidated and as a result we have a public health disaster with the under-treatment of chronic pain. This doesn't address the problem. We have to get treatment for those who are dying because they're not being treated. We have to find a rational way to regulate these substances, and I think there is a very good model with alcohol and tobacco, both of which are infinitely more dangerous than the opiates," he argued.

While Fisher was harshly critical of the DEA, he did concede that the proposed policy statement suggested the agency was concerned about a backlash. "It is telling," he said, "that the DEA now seems to be concerned about its image. In that sense, it's a sign of progress, but the DEA isn't really the problem -- the Controlled Substance Act is the problem. This is fiddling while Rome burns," he said.

"The DEA has been intransigent in its positions, and this is the first crack we've seen," said Kathryn Serkes, spokeswoman for the American Association of Physicians and Surgeons (AAPS), a 5,000-member, libertarian-leaning medical association that has long been active in the pain wars. "I think with the Dr. Billy Hurwitz case and everything else that has been going on in recent years, we are reaching the tipping point," she told the Chronicle. "Through getting our side out in the media and on web sites, through telling our stories, and through the work of activists like [the Pain Relief Network's] Siobhan Reynolds, the public gets it now. The media gets it now. We have seen a change in the stories. It's not just about horrible doctors killing patients anymore; the reporters are writing about the problem of pain."

That new understanding is even starting to percolate within the political class, Serkes said. "The politicians are starting to get it. The only folks who haven't gotten it are law enforcement and the courts. I think the release of this policy statement was a strategic move by the DEA in the face of Hurwitz's successful appeal of his conviction. If I were the DEA, I would certainly be looking for something to show we were being responsive. I'm sorry to sound cynical, but this looks like an obvious attempt by the agency to manipulate the situation. Still," she concluded, "we'll take what we can get. We're working on the good dog theory with the DEA -- praise the dog when it does something good even if it has some behavioral problems. Good dog, DEA, but you're still in the dog house."

Despite some broader issues with the DEA, Dr. Howard Heit, a Fairfax, Virginia, pain management and addiction medicine specialist who worked with the agency on the new policy statement was very pleased with the looser prescribing rules. "This is a tremendous step forward in the common goal of achieving balance between the DEA and health care professionals," he told the Chronicle. "It will ensure that patients who need Schedule II drugs get them and will help decrease the diversion of prescription drugs."

Heit divided his patients into two types: stable and problematic. "With stable patients, those with no aberrant behavior who follow all the agreements, I can now write sequential prescriptions for patients that I used to have to see every month," he explained. "Now I can see other patients because the stable patients don't have to come back unnecessarily. On the other hand, with my patients with problematic behavior, I want to see them every two weeks and more tightly control the medications. That prevents a greater quantity of medicine getting out that can be misused or diverted," he said.

"The DEA said they made a mistake in not allowing us to do sequential prescriptions," said Heit. "Now they are allowing us to do this. The DEA is responding to the health care community, and this opens up dialog that has been rather closed in the past two years. This is a step in the right direction. The rules of the game are being set up. The DEA has also stated they do not want to practice medicine, but it is their charge to enforce existing regulations. While I feel it is the prescriber's responsibility to know and follow federal regulations for prescribing controlled substances, it is also the DEA's responsibility to ensure that all DEA agents enforcing these regulations are knowledgeable about them."

Despite problems with the DEA in the past, particularly around the abortive pain FAQ in 2004, Heit said there was no option but to work with the agency. "The DEA isn't going away, the patients aren't going away, I'm not going away. We need to communicate with each other."

Dr. David Joranson of the Pain and Policy Studies Group at the University of Wisconsin Comprehensive Cancer Center, which had worked closely with the DEA on the abortive FAQ but not on this latest policy statement, was reluctant to render a verdict on it. "We're still analyzing the proposal and are trying to help people think through it," he told the Chronicle.

One point Joranson made was that much of the reporting about limitations on prescribing opiates is mistaken, and it isn't just the reporters getting it wrong. "There is currently no 30-day refill requirement," he said. "The DEA has clarified that there is no such requirement. There is not a word in the law or the regulations about that, and if everyone is saying there is, everyone is wrong." Even physicians are often mistaken about the law, he said. "The literature shows that medical professionals often have an inadequate understanding of the law and regulations regarding prescription practices."

Even though the DEA's own press release announcing the proposed policy statement said it "will allow a physician to prescribe up to a 90-day supply of Schedule II controlled substances during a single office visit, where medically appropriate," that press release is misleading, said Joranson. "The statement implies there is a supply limit now, but in fact a physician can prescribe any quantity of a controlled substance on a single prescription."

But Professor Ronald Libby, a University of North Florida political scientist who is writing a book on the clash between the imperatives of medicine and those of law enforcement, was not so sure patients would benefit from the relaxed prescribing rules. "General practitioners are already scared to death to write prescriptions in the first place because of the DEA," he told the Chronicle. "If they're afraid to write one prescription, why should we expect them to feel more secure writing three?" he asked.

"I don't see any real change in policy," said Libby. "Other than the 90-day prescription thing, I just don't see anything. The DEA is basically fulfilling its promise to replace the FAQ, and here it is. This is largely tokenism because the DEA is feeling the heat," he said.

Continuing discussions between the DEA and the health care community are not going to resolve the contradictions, said Libby. "I don't think you can get at the underlying issues unless and until there are congressional hearings on the DEA," he argued. "They're more secretive than an intelligence agency. It's almost impossible to get information from them, even for members of Congress."

[Editor's Note: Years ago I heard an analyst tell attendees at a forum that researchers at the federal Government Accountability Office liked to say DEA stands for "don't expect anything, don't even ask." -- DB]

But Libby doesn't see congressional hearings happening any time soon. "Let's face it. The drug warriors are in full bloom. The climate of the country is not conducive. They've managed to equate illicit drug trafficking with terrorism, and as long as that's the case and they include practitioners and patients in that war, the only way to move forward is to excise this diversion stuff from the war on drugs. But even though the pain foundations and people like the Pain Relief Network have been trying to get hearings for years, we can't get them. If the Democrats win the House, that might change, but members have to consider the fallout. If you take a hard-line position against the DEA, you become a target yourself."

"To view this as significant is to miss the point," said Siobhan Reynolds of the advocacy group the Pain Relief Network. "Pain patients have been suffering from an unbelievable crackdown, a reign of terror that has cost people their lives," she told the Chronicle.

It's very personal for Reynolds. One of those pain patients who died was her husband, Sean Greenwood, who succumbed earlier this month to Ehlers-Danlos Syndrome as he and Reynolds desperately traversed the country seeking adequate levels of prescribed pain medications for him. Because anti-terror precautions precluded them from taking medicines on airplanes, the family was forced to drive cross-country in search of a physician who would prescribe the massive doses Greenwood needed. He died in a motel room in a state Reynolds does not want to identify for fear of leading the DEA to the doctor they were seeking.

"People do not understand the enormity of what patients face," she said. "Because doctors are so afraid of law enforcement, they have projected their fear onto these patients and these drugs, so that sick people taking pain meds frighten hospitals and doctors. Sean needed a lot of hospital care, but they didn't focus on his medical problems because everyone is in the witch hunt mode about opiates. All the hospitals would talk about was giving him Narcan, as if the opiates were responsible for his medical problems," she said.

"My son watched his father die for no good reason," Reynolds continued. "He couldn't get into a hospital because of a government crackdown nobody is willing to admit is going on. No one can get the serious doses of pain medications that these really sick people need, and that's a real human rights catastrophe, and the DEA making a shiny new policy statement that basically says the same thing as before is not going to change anything."

What is needed, said Reynolds, is an all-out legal assault on the DEA's prescription drug control edifice. "We need multi-layered litigation with multiple plaintiffs going after different elements of this problem." But that will require a larger commitment from reformers than has so far been forthcoming. "We are in a gridlock of grief here, and nobody seems to care."