OUCH! THE DEA'S BAD-FAITH WAR ON PAIN DOCTORS

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.

In fact, while Hurwitz's trial was in progress, the DEA updated its
Web site to state that the document in question was withdrawn because
it contained misstatements. But this past June, Mark Caverly, the
head of the liaison and policy section for the DEA's Office of
Diversion Control, finally "acknowledged the Hurwitz trial was one
reason the FAQ were pulled," according to New York Times Magazine
reporter Tina Rosenberg.

With no clear guidelines in place, then, the federal government
continues to make examples of prominent pain doctors around the
country, such as Hurwitz and Zolot. So far, it's been a largely
successful strategy, in that it has forced all pain doctors to screen
their patients more carefully. But at what cost?

Not once since the deletion of the FAQ document from the DEA's Web
site has the government seriously sought to cooperate with leaders in
the medical profession to define, once and for all, illegal medical
practices in the area of pain management. Such an effort would allow
legitimate medical practitioners to feel more comfortable prescribing
opiate therapy and to help patients manage their chronic pain and
regain control of their lives. Plus, it would facilitate the
government's ability to punish doctors who do in fact cross that line
between good- and bad-faith medicine.

The medical profession may not like having federal bureaucrats play
such a large role in defining professional standards, but its overt
clarification of rules would be a major improvement over the current
system, in which doctors have no idea when their medical judgments
might land them in prison.