These are indeed perilous times to practice medicine. There has been much debate about whether it is becoming too expensive for doctors to practice because of the increasingly onerous rates for malpractice insurance. That debate centers on the question of who should bear the risk of medical mistakes and how high medical malpractice insurance premiums can rise before doctors begin to abandon certain areas of specialization.
What is given much less attention, however, is another risk attendant to medical practice, namely federal indictment. That risk is particularly acute for certain medical practitioners, such as those who treat chronic pain. It also extends to those physicians, hospitals, and clinics which collect fees from federal government medical programs, as well as many others. The list of physicians subject to all-too-easy indictment for violations of federal laws is long because the governing statutes and regulations are deceptively easy to violate. These laws are not readily understood by medical practitioners operating in good faith because they are vague, complex, and often self-contradictory. If one adds up the number of physicians who are threatened by this state of affairs, it constitutes nearly every physician practicing medicine today.
So how did Dr. William Hurwitz’s nightmarish encounter with the feds come about? Prosecutors contended that the physician had crossed the line from healer to criminal drug merchant. He had done so by dispensing massive quantities of pain-killers to patients who had criminal records or whom he knew, or should have known, to suffer from addiction. Hurwitz faced a 49-count indictment for drug trafficking, conspiracy, and even running a criminal enterprise, all stemming from his narcotics-dispensing activities. The fact that he operated with a prescription pad rather than on a dark street corner did not matter. A drug dealer was a drug dealer.
One cannot truly understand Dr. Hurwitz’s indictment without first understanding “the war on drugs,” a political and cultural initiative that has handed the Department of Justice a goody bag of dangerously pliable statutes and regulations with which to criminalize yet another profession with its own time-honored practices and ancient standards.
Federal criminal regulation of narcotics began with the Harrison Tax Act of 1914, targeting the non-therapeutic, addiction-related, and recreational uses of opium, morphine, and cocaine, used at the time for a variety of medical conditions and procedures. This legislation marked the beginning of a long-running federal assault on the medical profession and its patients, particularly those addicted to narcotic drugs, whether for recreational or therapeutic reasons.
The Comprehensive Drug Abuse Prevention and Control Act of 1970 replaced this antiquated statutory taxation scheme with a law more directly controlling the use of narcotic drugs. Bureaucratic maneuvering led the initial agency charged with enforcing the act, the Bureau of Narcotics and Dangerous Drugs, to be replaced by the U.S. Drug Enforcement Administration (DEA) in 1973 as an arm of the Department of Justice. In addition to its drug interdiction and antitrafficking activities, the DEA has long had an intimate role in regulating the ability of doctors to prescribe certain medications. For example, physicians, researchers, and others with access to controlled substances are required to register with the DEA and apply for a unique identification number that allows the DEA to track who is authorizing use of or research into those controlled substances.
Title II of the 1970 Act (dubbed the Controlled Substances Act) classified drugs by weighing their potential for harm against their therapeutic benefits. Drugs such as marijuana and heroin, with no officially recognized therapeutic use but with a perceived high potential for addiction or other abuse, were placed in Schedule I. Schedule II listed narcotic and non-narcotic drugs including cocaine, methadone, oxycodone and its time-release formulation known as OxyContin®, as well as a variety of amphetamines and barbiturates that carried what the government deemed a high risk of severe addiction. Analgesics and other drugs with lower risk of addiction filled out Schedules III, IV, and V.
The classification of these drugs into categories purportedly balancing therapeutic value against addictive and recreational potential signaled the new, supposedly modern, more scientific approach to federal drug regulation. Such, however, turned out not to be the case. Instead of achieving a medically-rooted balance, the feds drew an arbitrary line between what they believed to be the appropriate medical administration of pain-killing drugs versus “drug dealing” by physicians. Worse, the regulatory language made it virtually impossible for even the most responsible pain specialist to discern when he or she crossed the line into an area the DEA would consider akin to “street dealing.”
At the center of much federal drug law enforcement is a line drawn between drugs taken for “recreational” or “addictive” purposes rather than for therapeutic benefit. When a pain physician either gives a patient too much of a controlled drug or dispenses such drugs when he or she arguably should have known that some of it might get diverted to narcotics addicts, the physician is considered to be no longer engaged in the legitimate practice of medicine. The trouble is, the same approach applies whether a patient in pain takes more drugs than needed, redistributes drugs for addictive or recreational use, or is in real pain and seeks to get more medication due to an inordinate fear of being under-medicated. In the latter circumstance, a patient will sometimes exaggerate pain, with no ill intent.
The fundamental problem faced by physicians who prescribe controlled pain-killers in their medical practices is that a doctor’s therapeutic standards and judgment often differ considerably from a law enforcement agency’s definition of “abuse.” What would seem to be the good faith practice of medicine to a physician can readily be deemed abusive by a narcotics agent or bureaucrat. In fact, there is no single standard for the appropriate administration of narcotics since one deals here with a physician’s therapeutic discretion, which varies from doctor to doctor and from specialty to specialty. It’s true that abuse and malpractice are committed by some pain-treating physicians, but the federal scheme for controlling abuse second-guesses physicians in a manner that pressures them to act more like cops than docs.
The indictment against Dr. Hurwitz charged that he had not just stepped, but leapt across the line separating acceptable from unacceptable prescribing practices for the powerful, and effective, analgesic OxyContin®. OxyContin® is an enormously important medication. Placed on the market by the pharmaceutical company Purdue Pharma2 in 1996, OxyContin® is a form of the narcotic drug oxycodone and is a therapeutic improvement over the original because it is released more slowly and steadily into the patient’s system. This “time release” aspect of OxyContin® makes it particularly useful for relieving extreme pain for hours at a time. While other types of pain medication might last only a few hours, orally administered OxyContin® delivers pain relief over 12 hours with a single dose. A pain victim can go about a full day’s work or other tasks without constant and debilitating agony. As an analgesic, OxyContin® also produces feelings of relaxation and euphoria by targeting the central nervous system’s opioid receptors. Of course, if OxyContin® is taken contrary to the instructions provided by the physician and the label, that is, if pills are crushed and snorted or chewed rather than swallowed whole, the narcotic effect is delivered in one huge euphoric “hit.” Thus, this particular drug can be readily abused by drug addicts looking for a high.
Here is where things get truly murky: any patient who ingests increasingly large doses of a narcotic to achieve relief from pain can readily, and likely will, become physically dependent on that drug for pain relief, much like a diabetic becomes dependent on insulin. Others are more susceptible psychologically to becoming addicted.3 As one prominent medical pain practitioner has observed, “the confusion between addiction and physical dependence is probably the biggest single misunderstanding about opioids.”4
Treating physicians, of course, must navigate these shoals to make proper judgments about when continued administration of narcotics is clinically appropriate and when to wean the patient who exhibits sig
ns of addiction. Of course, it is sometimes true that a patient becomes addicted and tells all kinds of phony stories to convince his or her physician to continue prescribing narcotics long beyond the point when the patient’s actual medical condition warrants it. Physicians practice as much art as science in making proper judgments about their patients and have historically subjected the delicacy of such professional calls to licensing and peer-review controls.
Federal narcotics officers wield less subtle judgments and weapons. They are not always likely to recognize the weaning stage and can too readily assume that the doctor is maintaining an addict. Putting it charitably, they are inclined to err on the side of strict caution in these matters. Their worldview calls to mind H.L. Mencken’s definition of Puritanism: “the haunting fear that someone, somewhere, may be happy.” If one has any doubt about the DEA’s often black-versus-white moralistic and punitive agenda, one need look no further than the way the agency deals with marijuana.5 The fight for its approved medical uses has a long and continuing, largely unhappy history.6
Dr. Hurwitz was described by The Washington Post as “a major figure in national pain management circles.”7 Given Dr. Hurwitz’s fame, it should come as no surprise that the feds would make him a high-profile target, an object lesson for the entire profession. Bringing him down was an opportunity and a challenge, even a coup. And this was facilitated by the endlessly malleable statutes and regulations in the narcs’ arsenal. Then-Attorney General John Ashcroft himself announced Hurwitz’s indictment, noting that the doctor had been involved in “traffic in [a] very dangerous drug.” True to form, the news media fanned the flames.8 Newsweek published a story in 2002 on “Oxybabies,” a term analogizing the children of pregnant women who consume OxyContin® to “crack babies.” The Boston Globe ran a page one article in August 2004, trumpeting the inevitable local arrival of a federal program targeting OxyContin® abuse.9 A local official declared that “OxyContin® use can lead to heroin use.” Another local official said OxyContin® abuse was “the number one health crisis in cities and towns at this time.”10 It didn’t help that the image of an epidemic was facilitated by the spate of drug thefts from pharmacies and hospitals at the time. The specter of a crime wave was created by the prosecution statistics generated because prosecutors consider every prescription a separate felony count, so the charging statistics reach phenomenal numbers for each patient in these cases. These numbers became the stuff of screaming headlines in Dr. Hurwitz’s case, even though his attorneys estimated that no more than five to ten percent of his patients misused or resold the drugs.
In court, federal prosecutors never claimed that Dr. Hurwitz actually sold the drugs, or prescriptions for them. Instead, they charged that his income was increased from patients who came to him in the belief that they could get away with faking or exaggerating their pain. Prosecutors claimed a “conspiracy of silence” whereby the patients would mislead the doctor and the doctor would cooperate by being too readily misled—“a wink and a nod” arrangement.
In Dr. Hurwitz’s case, it turned out that some 15 of his roster of over 500 patients whom he was treating for chronic pain had been lying to him in order to get prescriptions and then resell the drugs. When federal agents learned of this, instead of alerting the doctor, they allowed the prescribing to continue and then made deals with the patients who had been lying to their doctor. Call it the medical version of ladder climbing: if the patients would testify against Dr. Hurwitz, they themselves would get lenient sentencing deals. It was, of course, easy to get many of the patients to tell whatever tales the agents and prosecutors needed to put the doctor behind bars for decades. The patients merely had to convince the jury that they gave the doctor enough information to know that they were abusing or reselling drugs that he prescribed.
A principal problem for Hurwitz’s defense was that it was not enough for him to demonstrate that he treated his pain patients in “good faith.” He also had to demonstrate that his prescribing practices were “in accordance with established medical norms.” Those norms, in the kind of trial Dr. Hurwitz was facing, had been increasingly determined by the DEA rather than by the medical profession.
So it came as a relief when, just before Hurwitz’s 2004 trial, the DEA appeared to make an about-face in a rare and overdue gesture of cooperation with health care professionals. It joined the Last Acts Partnership and the Pain & Policy Studies Group at the University of Wisconsin to produce a pamphlet that went up on the DEA’s and other Websites: PRESCRIPTION PAIN MEDICATIONS: Frequently Asked Questions and Answers for Health Care Professionals, and Law Enforcement Personnel.11 This FAQ pamphlet discussed the nature of chronic pain and the importance of managing it properly. To that end, it sought “balance” between the need to treat pain and the prevention of the abuse and diversion of pain medications. It also conceded what pain doctors had long known: in cases of chronic pain, “the parameters of acceptable medical practice include patterns of drug prescription—such as long-term administration of an opioid drug at escalating doses and administration of more than one controlled prescription drug.” This description of proper medical practice found its way into the guide even though drug warriors had long claimed that in some contexts such escalation could be seen as a “red flag.” The pamphlet listed other “red flags” physicians should consider in determining whether a patient was seeking medical advice and treatment in good faith. And in an “important disclaimer,” it proceeded to warn that “lack of strict adherence to these suggestions does not imply that a particular practice is outside the scope of legitimate medical practice.”
Crucially, the guidelines distinguished between physical “dependence,” characterized by changes to the body resulting in withdrawal symptoms after use is stopped, and “addiction,” marked by continued use despite enduring drug-related problems.12 “Confusion” concerning the nature of addiction, the pamphlet conceded in a remarkable admission, “can lead to the withholding of opioid medication because of a mistaken belief a patient is addicted when he or she is merely dependent.” And such confusion “can lead to inappropriate targeting of practitioners and patients for investigation and prosecution.”
The guidelines finally made room for individualized treatment by giving physicians some flexibility to use their professional judgment in deciding how to read, and therefore treat, a patient. They attempted to clear up some questions related to opioid therapy, while admitting that the scientific literature is “limited” and that there is “multifaceted controversy” among experts. The approach was nuanced and balanced, with continual warnings that no one factor or group of factors was necessarily indicative of abuse. In other words, the FAQ not only gave physicians reasonably clear guidelines as to how to assess a case calling for opioid therapy, but also lent them some degree of freedom to exercise medical judgment. Now doctors would not only get to practice medicine, but they would not have to look at every pain patient as a potential trap.
Yet out of the blue this highly welcome FAQ was suddenly withdrawn less than two months after it was first issued in August 2004. Why? Because Dr. Hurwitz’s lawyers wanted to use the booklet to defend their client at trial, and this triggered the drug warriors’ recognition that, by providing both clarity and flexibility to physicians as the FAQ had done, it was more difficult to win their overzealous prosecutions. Winning cases prevailed over facilitating sound medical practice. Some within the DEA clearly agreed with the medical community on all of the facts of medical life set forth in the FAQ, but overall, the DEA was not going to admit to such agreement when it could result in the acquittal of a prominent pain-management physician it had already targeted. A “win at virtually any cost” mentality afflicts segments of the Department of Justice’s Criminal Division in general and the drug warriors in particular.
With the withdrawal of the FAQ, the DEA killed two birds with one stone. It both cemented the case against Dr. Hurwitz and reversed its first tentative step toward accommodating the medical profession’s fear of
getting ensnarled in a professional and legal nightmare whenever physicians treated patients in severe pain. After Dr. Hurwitz’s conviction was announced by the jury, U.S. Attorney Paul J. McNulty told The Washington Post that Dr. Hurwitz “was convicted of multiple drug-trafficking violations because he knew that many of his patients were abusing or selling prescription drugs.”13 Yet the patients who testified, in exchange for deals from prosecutors that protected them from getting slammed for their own drug abuse, gave the jurors details of precisely how they went about fooling the doctor—how they won the trust they later betrayed. As Reason magazine’s Jacob Sullum characterized the trial and the jury’s verdict, Dr. Hurwitz was convicted essentially of “trusting his patients too much.”14
The Hurwitz conviction was later overturned by the Court of Appeals for the Fourth Circuit, an intermediate appellate court known for its tough law-and-order, pro-government rulings in criminal cases.15 But even the reversal added to the fear that must beset every pain physician. The appellate court faulted trial judge Leonard D. Wexler for failing to instruct the jury that it must acquit Dr. Hurwitz if it found that he was operating in “good faith” and within “accepted medical practice.” Said the appellate court: “As an initial premise, we agree with Hurwitz that a doctor’s good faith generally is relevant to a jury’s determination of whether the doctor acted outside the bounds of medical practice or with a legitimate medical purpose when prescribing narcotics.” It continued: “Some latitude must be given to doctors trying to determine the current boundaries of acceptable medical practice.” Thus, the physician could defend by proffering to the jury evidence of his “good faith.” Yet the court went on to emphasize that the standard of good faith had to be an “objective” rather than a “subjective” one.
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