The long-simmering battle between federal drug law enforcers and pain management doctors, patients, and academics over the proper use of opioid pain medications such as Oxycontin is turning white hot. Between the Drug Enforcement Administration's (DEA) sudden reversal on a years-long collaborative effort with academic pain specialists over what constitutes acceptable opioid prescribing (http://stopthedrugwar.org/chronicle/365/faq.shtml) and the recent successful Justice Department prosecution of nationally known pain treatment pioneer Dr. William Hurwitz, mainstream medical organizations and personalities that had up until now been quietly complacent have begun to go on the offensive.
Pain doctors, patients and advocates fought back on several fronts this month. This week, three major medical associations representing pain specialists harshly and publicly criticized the DEA's sudden reversal on the prescribing guidelines for opioids. Those guidelines, which took the form of a "Pain FAQ," were the result of a multi-year collaboration between the DEA and academic pain specialists. They were posted on the DEA web site in August, but jerked down again weeks later without notice to the academics and replaced shortly thereafter with revised guidelines that stiffened the DEA's attitude toward what it termed improper prescribing. The letter, signed by the presidents of the American Pain Society (APS), the American Academy of Pain Medicine (AAPM), and the American Society of Addiction Medicine (ASAM) called the new DEA policy guidelines "an unfortunate step backward" that will only lead to "an adversarial relationship between doctors and the DEA."
The DEA responded with a statement from spokesman Bill Grant, who said the agency "wishes to reassure the public that the withdrawal of the August statement does not represent any change in DEA's investigative emphasis or approach. Physicians acting in good faith and in accordance with established medical norms should remain confident that they may continue to dispense appropriate pain medications."
Drug czar John Walters also attempted to address the growing controversy. At a Tuesday press conference, Walters told reporters that "synthetic opioids are of enormous medical benefit for people," but undercut himself with pain advocates by going on to say that among the doctors prosecuted as Dr. Feelgoods "there were not even any close calls."
The pain associations weren't buying it. Citing what they called "the over-aggressive prosecutions" of pain doctors, pharmacists, and other health professionals, the association presidents said that while the DEA says it does not want to stop doctors from adequately treating chronic pain with opioids, the new guidelines "will undoubtedly have the exact opposite effect on any practitioner reading them."
The association presidents, APS president Dennis Turk, AAPM president Samuel Hassenbusch, and ASAM president Lawrence Brown, zeroed in on the DEA's assertion that merely prescribing high doses of opioid pain relievers can lead to a doctor being investigated. Such statements will have a chilling effect on the practice of pain medicine, they wrote. "Reading that the government can investigate merely on suspicion that the law is being violated will send chills down the spine of practitioners who are treating patients with [narcotic painkillers] and will certainly contribute to the undertreatment or non-treatment of moderate to severe chronic pain."
"The bottom line on this letter is that if the DEA thought changes were needed, it should have engaged in a little more discussion about it and get everyone on board," said Chuck Weber, spokesman for the American Pain Society. "There was a real change in tone between what was agreed upon and posted in August and the revised guidelines issued last month," he told DRCNet. "The main concern was the lack of dialogue."
"This letter is absolutely a positive move," said Dr. Frank Fisher, a California pain specialist who was prosecuted and ultimately exonerated over his opioid prescribing practices and who served as a defense consultant in the Hurwitz trial. "Those academics spent years working with the DEA to come up with reasonable guidelines, but then the DEA jerked them down and didn't do the courtesy of notifying them," he told DRCNet. "The DEA has an absolute obligation to work with the academic community in promulgating guidelines, but what they have done is abrogate that responsibility and their duty to regulate controlled substances in a matter that makes them available to patients who need them."
The American Academy of Physicians and Surgeons, which for years has been waging a lonely struggle within the profession to protect opioid-prescribing doctors, also welcomed the intervention by the pain association heads. "Even though we weren't fans of the FAQ," said academy spokesperson Kathryn Serkes, "at least with them you got something on paper. You want government agencies to commit to something on paper so you know where the bar is, but when the bar keeps moving at the whim of prosecutors and investigators, you've got a real problem," she told DRCNet. "Doctors and patients are literally at the mercy of prosecutors and the DEA. We've been angry about this for years -- it's about time some of the other physicians' groups got angry, too. They've been manipulated and made fools of. At this point, anger is an appropriate response."
Another broadside against Justice Department tactics came in a December 10 letter from six past presidents of the American Pain Society harshly criticizing the testimony of yet another past APS president, Dr. Michael Ashburn, as an expert prosecution witness in the recently concluded Hurwitz trial. Prosecutors in that case used Ashburn to suggest to jurors that Hurwitz' practice was outside the scope of accepted medical procedure and that prescribing large amounts of opioids was, too.
But the APS past presidents disagreed in blunt terms. "We are stunned by his testimony," the letter said. "As leaders in this field, we feel compelled to correct the errors in his testimony, lest it be used in the future in a manner that worsens the national tragedy of untreated pain." Ashburn's testimony was filled with "serious misrepresentations" and "factually wrong or serious misstatements of consensus in the field," they wrote. In one example, the past presidents pointed out that Ashburn testified that the use of "high dose" opioid therapy, which Hurwitz practiced, was an indication of drug abuse in people not suffering from chronic pain from cancer.
"It is factually untrue that this is a consensus opinion of pain experts," the past APS presidents wrote. "We strongly hold the view that patients with non-cancer pain may benefit from opioid therapy and that the dose necessary to control pain may be high. Use of 'high dose' opioid therapy for chronic pain is clearly in the scope of medicine." Ashburn's characterizations of what constituted "high dose" opioid therapy was so low as to be simply "absurd," the doctors added.
Similarly, Ashburn testified that prescribing opioids to patients with addiction problems is medically unacceptable. "This is not the view of experienced clinicians in the field," the past presidents complained. "It is unacceptable to promulgate the view that the disease of addiction automatically denies patients with severe pain the possibility of relief through careful opioid therapy," they wrote.
"We will try to correct the public record after the trial concludes and sincerely hope that the government and the court will consider this information now," concluded the letter from Russell Portenoy, MD, chairman of the Department of Pain Medicine and Palliate Care at Beth Israel Medical Center; James N. Campbell, MD, director of the Blaustein Pain Treatment Center at the Johns Hopkins University Medical Center; Kathleen Foley, MD, of Pain & Palliative Care Services at Memorial Sloan-Kettering Cancer Center; Charles Cleeland, PhD, director of the Pain Research Group at the University of Texas MD Anderson Cancer Center; Christine Miaskowski, RN PhD, chair of the Department of Nursing at the University of California San Francisco; and Richard Payne, MD, director of the Duke University Care at the End of Life program. According to Fisher, however, though the letter was seen by the judge, it was not shown to the jury.
Ashburn, who currently works for a pharmaceutical company that is developing products that would compete against opioid pain relievers, declined a DRCNet offer to comment either in general or on the specifics of the accusations against him.
"This letter publicly criticizing Ashburn has enormous significance," said Dr. Fisher. "What Ashburn did in his testimony is similar to what so-called experts have been doing to doctors all over the country, but this time it came out in the closely watched trial of a prominent and well-respected physician. This time they didn't get away with it."
"They are finally waking up," exclaimed Siobhan Reynolds, executive director of the pain patients and doctors advocacy group the Pain Relief Network (http://www.painreliefnetwork.org). "What happened to Dr. Hurwitz symbolizes the vulnerability of doctors who treat pain with opioids. The medical profession knows this and can't deny it. Dr. Hurwitz is a political prisoner, it's as simple as that," she told DRCNet. "He refused to plead guilty and now they are making an example of him. But his example is serving to awaken political consciousness among physicians. That makes me slightly optimistic," she told DRCNet.
Even the American Medical Association is finally bestirring itself. The largest doctors' organization in the country voted at its Interim Meeting in Atlanta this month to "support interpreting federal law in a way that would let doctors continue to write pain medication prescriptions for patients in need, while letting the government provide oversight and regulation to minimize risks to patients' health and safety," according to this week's AMA newsletter. The groups will "voice concerns to DEA over pain medication prescribing policy," the newsletter added.
The AMA did not mention the prosecutions of pain management physicians, but it did express concern about the mysterious vanishing Pain FAQ and its new, hard-line replacement. "The AMA will work with the DEA to address physician concerns that an interim policy statement published by the agency in November could interfere with the way doctors prescribe opioid analgesic medications to some patients," the report said. "Doctors worry that the statement could make it illegal to write multiple pain medication prescriptions for a patient on the day of a visit and evaluation. Physicians also worry that they no longer could legally write directions for dispensing additional medication on future, specified dates."
AAPS' Serkes pronounced herself "optimistic but cautious" about the AMA pronouncement. "I hope it's not just for show," she said. "A couple of years ago the AMA came out with similar pronouncements, they said they were going to make this an issue, but then did nothing. Something has to happen now. We are at the point where -- and it is painful to say this -- we are recommending to doctors that they not prescribe opioids in treating pain. Not that doctors are waiting to hear from us. I quietly hear from doctors on a regular basis that they will not treat pain patients for fear of the consequences. That doesn't make the news, it doesn't have a high profile, but there is another doctor who will not be treating pain patients."
The battle over heavy-handed DEA and Justice Department regulation of the practice of pain medicine is far from over, but now, at least, it appears the battle has been joined by the medical mainstream.
(Meanwhile, Dr. Hurwitz sits in federal detention awaiting sentencing and an appeal. That appeal will cost $60,000 that Hurwitz doesn't have and needs to raise by mid-January, said Reynolds. Reynolds and the Pain Relief Network have established a Hurwitz Defense Fund. People interested in contributing can send checks made out to Pain Relief Network -- write "Hurwitz Defense Fund" in the memo -- and send to PRN at P.O. Box 231054, New York, NY, 10023. Contributions are tax-deductible. Let them know you heard about it from DRCNet.)