Things haven’t been going well as of late for Needham-based chronic-pain specialist Dr. Joseph Zolot. In May, state and federal officials seized his office records. One month later, the state Board of Registration for medicine revoked his license. Now that the US Drug Enforcement Agency (DEA) and local police have launched a criminal investigation into whether he overprescribed narcotic painkillers such as OxyContin to patients, Zolot’s troubles are about to multiply.
The notion that Zolot crossed the line that separates legitimate treatment from enabling destructive narcotic addictions — that is, the line between ethical doctoring and a serious federal felony — presumes that such a distinction has been made. In fact, federal drug-enforcement authorities have never given physicians much guidance as to what constitutes legal versus criminal prescribing conduct.
Yet the feds continue to prosecute a handful of pain specialists every year, sending well-meaning doctors into a panic that they, too, will be the victim of ill-defined laws. For Zolot, that threat is all too real, as his will likely be the next name on the docket.
Disappearing standards
The relationship between pain doctors and the federal government has long been strained, dating back to the advent of the “war on drugs” in the early 20th century, when opioids and other analgesic drugs were first regulated.
At the time, medical professionals resented anti-drug bureaucrats for dictating what modes and amounts of anti-pain medication were appropriate. Yet in recent decades, doctors have accepted that government interference is likely here to stay. Their main complaint now is not that the government seeks to regulate prescription drug use; it’s that the laws are so vague.
Given the medical difficulties of treating patients in acute pain (or those who are willing to fake pain in order to get narcotics), this state of affairs poses grave legal dangers to conscientious physicians.
But it doesn’t have to be this way.
In 2004, in a rare and long-overdue gesture of cooperation with health-care professionals, the DEA produced a pamphlet, also posted on its Web site, titled “Prescription Pain Medications: Frequently Asked Questions and Answers for Health Care Professionals and Law Enforcement Personnel.” The tract, co-written with the Pain & Policy Studies Group at the University of Wisconsin, was a well-reasoned and thorough guide to prescribing controlled narcotics. June Dahl, a University of Wisconsin-Madison professor of pharmacology, even hailed the guidelines as “a great step toward reducing the barriers” to the treatment of severe pain.
“It’s amazing how much confusion there still is,” Dahl told the Associated Press in August 2004. “There is a reluctance to give adequate doses. It kind of seems unbelievable that there is a reluctance to treat people who are dying.”
Two months later, though, the tract was removed from the DEA’s Web site. Doctors expressed shock, while 30 state attorneys general signed a letter to the Justice Department protesting the puzzling move. “Adequate pain management is often difficult to obtain,” wrote the attorneys general, “because many physicians fear investigations and enforcement actions if they prescribe adequate levels of opioids or have many patients with prescriptions for pain medication.”
No matter. The DEA was then prosecuting a high-profile pain specialist in the US District Court in Alexandria, Virginia. So the document had to be expunged, lest it seriously damage the feds’ prosecutorial rationale.
Pain in the FAQ
In a criminal case similar to Zolot’s, Virginia-based Dr. William Hurwitz, an outspoken advocate of opioid therapy for chronic-pain suffers, was indicted on dozens of counts of drug trafficking, conspiracy, and even running a criminal enterprise. Unfortunately for Hurwitz, his defense team not only needed to prove that he treated his patients in “good faith.” It also had to demonstrate that Hurwitz’s prescribing practices were “in accordance with established medical norms.”
Since the DEA’s own FAQ booklet attempted to define those norms, Hurwitz’s defense lawyers had hoped to use the pamphlet to defend their client. But once the DEA, recognizing the FAQ’s utility to the defense, had removed the document from its Web site, it no longer constituted official government policy and was therefore of no legal help.
Had the document been allowed into evidence as the official government position, however, it would have demonstrated the difficulties doctors face when trying to define an “objective” standard of good faith. It also would have given jurors a list of “red flags” that physicians should consider when they suspect a patient is seeking a narcotic “fix” rather than legitimate medical advice and treatment. And in an “important disclaimer,” it would have warned that “lack of strict adherence to these suggestions does not imply that a particular practice is outside the scope of legitimate medical practice.” The scientific literature is “limited,” the DEA literature had concluded, and there is “multifaceted controversy” by experts in their field.
With that pamphlet, the government had come dangerously close to acknowledging the realities of modern pain medicine. Instead, it retreated from the FAQ because it considered winning the Hurwitz case to be more important than clarifying proper treatment of chronic pain.