Three Felonies a Day

by Harvey Silverglate

  Let us take a step back. The drug warriors were turned back when they sought, by regulations, to establish a national standard defining good faith and proper medical practice in end-of-life situations. But they continue to establish de facto national standards in the pain relief arena, not by administrative regulation, but rather by case-by-case prosecution. In this manner, the drug warriors have, in fact, achieved their aim of regulating pain medicine by an in terrorem series of prosecutorial strikes, most of which appear to have succeeded in frightening pain doctors and deterring them from following the best medical judgments of the profession and of state medical regulators. In this manner, a national standard for pain relief has been established, and it is a vague standard dictated by cops, not doctors.33

  We have yet to see if and how Congress will react to these and future court opinions. Congress might decide to use the power acknowledged by the Supreme Court to make clear its intention to give the drug warriors the power to determine the parameters of good-faith medical treatment. The most potent danger is that Congress will allow the current vague statutory and regulatory framework to persist and, as a result, drug warriors will retain the de facto ability to regulate the practice of pain medication.

  As we have seen, federal law is sufficiently malleable so that a physician can be indicted, even convicted, for engaging in activity that he or she has good reason to believe is lawful. This vulnerability extends not only to physicians dispensing pain-management medicine and hastening death under a duly enacted statute (as in Oregon), but also to those complying with the enormously complex federal regulatory scheme, the Federal Food, Drug and Cosmetic Act (FDCA).34 Just ask Dr. Peter Gleason.

  When Dr. Gleason was picked up and arrested on a Long Island train platform, the Maryland doctor thought, “Well, this is a gag.”35 It was no joke. The U.S. attorney for the Eastern District of New York in 2006 indicted Dr. Gleason, a licensed psychiatrist who treated patients for, among other things, sleep-related disorders. The crux of the charge was that he illegally prescribed and promoted the drug Xyrem®, manufactured by Orphan Medical, Inc. Dr. Gleason touted the effectiveness of Xyrem® in the treatment of narcolepsy (a sleep-cycle disorder) and cataplexy (a condition associated with weak or paralyzed muscles). The Department of Justice was particularly concerned by this drug because it contained an active ingredient—gamma-hydroxybutyrate (GHB)—that prosecutors believed doubled as a “date-rape” drug, according to the indictment. The government also linked the drug to serious adverse side effects. The drug had earlier been prohibited by the FDA, but was then approved for medical use as Xyrem® in 2002. Like Oxycontin®, Xyrem® draws a wary eye from prosecutors and hence is prescribed hesitantly by physicians despite its important therapeutic uses. By bucking this trend, Dr. Gleason made himself a target.

  When a drug is approved by the FDA for marketing, the manufacturer is required to include a label that tells the prescribing physician and the user what medical conditions the drug has been shown to be safe and effective in treating, as well as the recommended doses and other instructions for use. It is unlawful for a drug manufacturer to tell physicians or patients that a drug has been found useful in treating conditions other than those listed on the label or that a drug may be administered other than as prescribed on the label. However, it often happens that treating physicians learn, from experience, a colleague, a medical journal, or other such reliable source, that a drug is effective for certain so-called off-label uses.

  The indictment charged Dr. Gleason with touting the drug for off-label uses, including “fatigue, chronic pain, weight loss...depression, bipolar disorders, fibromyalgia, insomnia and movement disorders such as Parkinson’s disease.” Physicians, however, are clearly allowed by law to prescribe drugs for off-label uses. The FDA prohibits only the drug manufacturer from promoting the product for such unapproved purposes. This accommodation was made so as not to unduly interfere with the practice of medicine and the hands-on experience of physicians. But because of the drug warriors’ concern about a drug they viewed as having potential for “recreational” use and therefore abuse, a physician touting Xyrem® to his fellow physicians for off-label uses would be well advised to proceed with extreme caution bordering on paranoia, since, despite being legal, it could land him in prison.36

  In fact, because obtaining FDA approval to market a drug for a particular use is so complex, expensive, and time-consuming, many manufacturers don’t bother to obtain permission to market a drug for more than a single medical condition. For a long time, the drug Lyrica® (pregabalin) had been governmentally approved to treat only neuropathic pain, but pain physicians prescribed it usefully, but “off-label,” for another pain condition, fibromyalgia. (It was later approved by the FDA to treat fibromyalgia.) Neurontin®, a drug approved for seizure disorders, has enjoyed wide off-label use to treat neuropathic pain. An ultra short acting form of the drug fentanyl, named Actiq® or Fentora®, FDA-approved only for treatment of cancer pain, has been found by physicians to be very effective for off-label use on non-cancer pain. Physicians routinely notify their colleagues, at professional conferences and elsewhere, of these uses based on experience. When I told a prominent physician about Dr. Gleason’s case, she expressed considerable dismay because sharing off-label treatment successes among colleagues is ubiquitous within the medical profession and of great therapeutic value. The Gleason arrest and prosecution would “certainly put the fear of God into physicians,” she predicted.37

  So how did the Department of Justice manage to arrest Dr. Gleason for touting and using Xyrem®, despite his right to do so? It charged him, first, with working with the manufacturer in a joint scheme to promote the drug for off-label uses. Orphan, according to the indictment, paid for Dr. Gleason to attend events at which the drug was discussed among physicians. It was at such conferences and dinners that Dr. Gleason allegedly promoted the off-label uses, and he also advised physicians how to get various medical insurance plans and programs to pay for such uses. As a result, he was indicted for two crimes. First, he was involved, said prosecutors, in a “conspiracy” with the manufacturer to promote the off-label use of the drug. By alleging that the company paid for Dr. Gleason to attend the conferences at which he touted the drug, the indictment managed to tag the physician with prohibitions against such touting that, in theory, bind only the company. The indictment further charged Dr. Gleason with a conspiracy to commit health care fraud by advising physicians how to get public and private health insurance plans to pay for such off-label uses. Seemingly lost in this morass of conspiracy law, alleging a joint undertaking by a physician and drug manufacturer to do what the drug manufacturer could not do on its own, was the question of whether Dr. Gleason’s medical practice in fact demonstrated the efficacy, for his patients, of Xyrem’s® off-label uses.

  The indictment was what a lawyer would call creative. By the macabre magic of the nearly formless conspiracy laws, the DOJ was able to turn an innovative and law-abiding physician into a criminal.38 It was in effect able to write a statute—prohibiting physicians from touting and engaging in off-label uses—that Congress has resolutely refused to enact.

  A physician in Dr. Gleason’s position would want, for the sake of his reputation, to fight such a charge rather than to make a deal. Yet a deal might very well have been what prosecutors had in mind when they indicted Dr. Gleason, hoping perhaps that they could persuade him to testify against Orphan. But first, they had to dissuade the doctor from challenging the tenuous indictment in court, where the charges could unravel under scrutiny.

  How did they do so? The indictment contained a “criminal forfeiture allegation” that sought to force Dr. Gleason to turn over to the government “any property, real and personal, that constitutes or is derived, directly or indirectly, from gross proceeds traceable to the commission of offenses.” In other words, he would be forced to turn over a rather substantial amount of money and property. Often the net effect of such a forfeiture is to bankrupt the defendant. Frequ
ently, when there is a forfeiture count in such an indictment, prosecutors seek a pre-trial freeze on the defendant’s assets, depriving him of the ability to pay for top-flight criminal defense counsel. By depriving the physician of the ability to defend himself vigorously and therefore of the right to a fair trial, the government makes a guilty plea with an agreement of cooperation far more likely, indeed almost inevitable. It’s a good bet that a federal criminal defendant is in for a hard, and usually losing, fight when his assets are frozen at the same time high bail is set. This is one reason the government tries so few of these criminal cases. In 2004, for instance, 90 percent of all criminal defendants brought before U.S. district courts were convicted, with 96 percent of those convictions resulting from guilty pleas.39 In other words, federal prosecutors operate in a justice system where even a trial is a rare luxury for most defendants.

  Despite early indications that Dr. Gleason would contest the charges, he eventually struck a deal. In August 2008, he pleaded guilty to a misdemeanor count of introducing a misbranded drug into interstate commerce. Because prosecutors agreed that Dr. Gleason had no intent to defraud or mislead, the felony charges were dropped. Nonetheless, Dr. Gleason faces up to a year in prison.40

  Of course, it is a well-recognized problem within the medical profession that physicians occasionally fall prey to the temptation of too aggressively touting pharmaceuticals for both on-label and off-label uses in exchange for lucrative lecture fees and all-expense paid trips to medical conferences held in exotic locales. Some hospitals and medical schools consider such arrangements to be a conflict of interest and control or even ban them. Other institutions approach the problem by insisting that physicians disclose all payments received from pharmaceutical companies for research or for educational and promotional activities. Some physicians voluntarily refrain from taking such fees. Dr. Daniel J. Carlat, for example, a psychiatrist and medical author who was trained at Boston’s renowned Massachusetts General Hospital, withdrew from the company-sponsored lecture circuit, from which he had previously earned some $30,000 a year to supplement his $120,000 salary. He feared, he said, that he was being paid “to say good things about drugs, regardless of what my actual opinions were.”41 Dr. Jerome P. Kassirer, of Tufts University, has written a book, On the Take,42 about how medical people have become too cozy with large pharmaceutical companies.

  All this is to say that abusive practices can be controlled with clear conflict-of-interest or mandatory disclosure rules developed within the profession and the industry or within medical schools. Failing that, state and even federal regulatory agencies might play a role. Indeed, in egregious cases, they might be dealt with by the criminal law, although this has proven to be a destructive tool thus far. Whatever legal regime is adopted to curb abuse surely should have the advantage of clarity, especially when the penalties are as draconian as they currently are under the federal criminal code.

  The feds’ efforts to assert control over such controversial areas of medical practice as pain relief, end-of-life issues, and off-label prescriptions hardly exhaust the possibilities. Another area of federal involvement in medical practice is guaranteed to keep virtually all practicing physicians on tenterhooks, namely the complex and turgid framework covering government payment for a huge variety of medical procedures and services. Physicians, as well as group medical practice and hospital administrators, can be driven to distraction by these regulations, and bills for medical treatments later declined for payment can have serious financial consequences for a physician or hospital left emptyhanded. However, a far more threatening situation develops when the Department of Justice decides to resolve billing disputes by invoking the criminal justice system.

  Consider the plight of two obstetricians/gynecologists, Drs. Bert M. Avery and John G. Migliaccio, practicing together as A & M Surgical, Inc., in Lawton, Oklahoma. They were indicted and tried in the early 1990s for filing false claims for payment with the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS), one of numerous government-funded medical coverage programs for federal (in this case, military) employees. (There are other federal health programs as well, including the vast Medicare insurance plan, that most physicians and hospitals come into contact with at some point.)

  The charge seemed deceptively simple: the physicians were charged with engaging in a conspiracy to defraud the United States by billing the government for surgical services not covered by the program. Tacked onto the indictment for good measure was the ubiquitous mail fraud count.

  The physicians had submitted to CHAMPUS claims for surgical procedures that included fallopian tube repair, a procedure not covered by the program. The female patients involved had earlier been operated on for tubal ligations, a female sterilization procedure more commonly known among laymen as having one’s “tubes tied,” a form of birth control. They wanted to have the procedure reversed in order to become pregnant. Reversal of tubal ligations, as noted, was not covered by the CHAMPUS program.

  The indictment alleged that the two doctors concealed from CHAMPUS administrators the true nature of the surgeries performed to induce the program to pay for the non-covered ligation reversal surgeries. How did the doctors accomplish this fraud on the federal treasury? First, they failed to document adequately in the medical records these patients’ previous tubal ligations. Second, in their claims for payment they labeled the fallopian tube repair surgery as “salpingoplasty” rather than the more common term “tubal reanastomosis.” According to the prosecutors, the doctors did this to hide from the bureaucrats who reviewed the bills the fact that they’d performed a non-covered procedure. The surgeons further carried out their false billing scheme, according to the indictment, by taking advantage of a rather complex section of the regulations dealing with surgeries in which more than one procedure is performed at the same time.43

  The question of guilt boiled down, in essence, to a contest over whether the surgeons’ primary purpose in performing the surgery was to accomplish the tubal ligation reversal or to repair some other condition covered by the regulations and then incidentally to perform the reversal while the patient was already on the operating table. The government’s expert witness testified that the primary purpose of the multiple surgeries appeared to have been to accomplish the ligation reversal in each case, even though the expert admitted that many of the patients had disease, and the expert did not identify a single patient who was free of disease. The defendant surgeons were adamant that each patient required surgery for a medical condition and that they performed the ligation reversals incidental to the major surgery rather than close up the patients and then re-schedule each for a follow-up, non-covered elective procedure. They were convicted, and they appealed.

  It became obvious as the appellate panel examined the regulations and the facts of the case that there was some problem figuring out precisely what the surgeons could have done, consonant with medical ethics and patient safety, to eliminate questions about the legal propriety of their actions. Conducting two separate surgeries so as to eliminate any possible suspicion that the surgeons tried to get paid for the ligation reversals would, quite obviously, have exposed the patients to a serious health risk and would likely have been deemed malpractice. No competent and ethical surgeon would readily place his or her own interest in satisfying skeptical government bureaucrats and prosecutors above the interests of the patient to avoid multiple operations. To do otherwise would be a clear case of the tail wagging the dog.

  The jury had convicted despite being instructed by the trial judge that “good faith” by a defendant would be a complete defense. However, the Court of Appeals noted that the real problem was that the regulations on this point were ambiguous. The court made the astonishing admission that “we have not previously addressed proper jury instructions in a false statement case such as this where the issue of ambiguity is inextricably intertwined with the defendant’s intent and good faith,” despite the fact that the false statement statute has be
en around since 1863. Well, better late than never. The court said that the jury should have been instructed “concerning reasonable interpretations of ambiguous requirements.”

  Proper jury instructions, the court realized, would likely have made a real difference in the outcome of the trial. In relation to two of the patients in particular, the court argued, the evidence showed “that the patients sought treatment for legitimate pelvic problems, regardless of the medical merits of [tubal ligation] reversals.” In other words, the patients needed surgery for medical reasons, and the ligation reversals were done secondarily, while the patients were already on the operating table.

  The doctors provided all of the necessary documentation to the CHAMPUS benefits office. The problem lay in the turgidity of the regulations concerning the coverage, or exclusion, of various surgical procedures. “Defendants did not plead honest mistake,” wrote the appellate court. “Rather, they contended that the CHAMPUS universe contains ambiguous matter, and that their interpretation was reasonable.” This contention should have been presented to the jury as a possible defense, along with the physicians’ contention that the CHAMPUS office should have understood that “salpingoplasty” accurately described the surgical procedure that the regulations dubbed “tubal reanastomosis.” The fault lay in the CHAMPUS clerical bureaucrats who had “the duty to evaluate claims and determine amounts of coverage and exclusions,” concluded the appellate court. In other words, they should have known what “salpingoplasty” meant.44

  Perhaps the most telling aspect of the case involved the conspiracy charge. A conspiracy is an agreement between two or more people to commit an illegal act. It is a separate crime from the illegal act itself, since such an agreement is a crime even if the conspirators never get sufficiently close to their goal to actually commit the substantive crime. If two people plan to rob a bank, and take steps to plan and then work toward the robbery itself, they are guilty of conspiracy even if they get caught before they actually leave for or arrive at the bank, much less pull off the robbery.