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Experts Worry About Chilling Effect of Federal

Regulations on Treating Pain
    Undertreated pain is a long-standing     OxyContin into illegal markets. As part           2 years working on the project. “It was
problem in health care. The American         of this plan, DEA officials increasingly           the first time the DEA had reached out to
Cancer Society suggests that up to 50%       targeted physicians and pharmacists.              the medical community to express support
of seriously ill and dying cancer patients       But even before the DEA’s action plan,        for the view that treatment of chronic
in the United States suffer from pain that   physicians were becoming hesitant to              pain is of paramount importance.”
could be adequately treated with avail-      prescribe opioid painkillers. Several high-          But then, without warning, the DEA
able drugs. Myriad factors contribute to     profile indictments heightened their fears.        pulled the FAQ off its Web site in Octo-
the problem; chief among them is that        Among them was the case of Frank                  ber. The DEA’s sole comment was that
many doctors are not well trained in         Fisher, M.D., a Harvard-trained pain              the FAQ was withdrawn because it con-
pain management, particularly with           specialist, who in 1999 was charged in            tained “misstatements.” However, it has
opiates such as methadone, morphine,         California with drug distribution, fraud,         been widely speculated that the DEA
and oxycodone.                               and 15 counts of murder, all related to           pulled the FAQ after it was cited by
    But also part of the problem, says       high-dose prescriptions of opioid pain-           defense attorneys representing William

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Russ Portenoy, M.D., chairman of the         killers. Fisher was exonerated on all of the      E. Hurwitz, M.D., a controversial
Department of Pain Medicine and Pallia-      counts, but it took 5 years for the charges       pain specialist who in December was
tive Care at Beth Israel Hospital in New     to be dropped, thrown out, or dismissed,          convicted on 50 counts that included
York, is that oncologists and physicians     and the process cost Fisher hundreds of           drug trafficking resulting in death and
alike are increasingly reluctant to pre-     thousands of dollars in legal fees.               serious injury.
scribe adequate pain relief to their             Ronald Libby, Ph.D., a professor                 The current substitute for the FAQ is
patients because they fear subsequent        of political science at the University            an interim statement—titled “Dispensing
investigations from law enforcement,         of North Florida, estimates that the              of Controlled Substances for the Treat-
particularly the U.S. Drug Enforcement       number of physicians now being                    ment of Pain”—that describes how
Agency (DEA).                                investigated for prescription drug                “DEA plans to address in a future Fed-
    “The DEA had previously been             diversion could number as high as                 eral Register document the issue of dis-
viewed [by physicians] as relatively en-     1,500 per year. “The DEA needs to                 pensing controlled substances for the
lightened,” Portenoy said. “Sadly, events    demonstrate to Congress that they’re              treatment of pain.” The interim policy
during the last 6 months suggest the         making progress in the war on drugs,”             statement was published in the Federal
agency has become confused about its         Libby said. “And targeting physicians             Register on Nov. 16. Comments from
mission and is now willing to pursue         is an easy way to come up with the                the public are now being received by the
policies that worsen undertreatment [of      numbers. Now, most doctors are terrified           agency, which plans to issue a complete
pain] in an effort to reduce prescription    to write these prescriptions.”                    statement at some point in the future.
drug abuse.”                                                                                   The DEA declined to answer questions
                                             A Reversal at the DEA
                                                                                               regarding its views on the subject for
Fear of Investigation
                                                 Aware of physicians’ growing                  this article.
   According to Judith Paice, Ph.D.,         unease, DEA officials in 2000 met with                The interim statement reverses the
research professor of medicine at North-     David Joranson, director of the Pain and          FAQ on several points. For instance,
western University Feinberg School of        Policy Studies Group at the University of         the FAQ affirmed that neither the
Medicine in Chicago, the roots of the ten-   Wisconsin’s Comprehensive Cancer Cen-             number of patients who receive opioids,
sion between physicians and the DEA          ter, and other experts to collaborate on a        nor the number of tablets prescribed to
dates back to the emergence of OxyContin     policy to balance medical use of painkill-        each patient, nor the duration of therapy,
(oxycodone hydrochloride) abuse, which       ers with efforts to stem their illegal diver-     should constitute the sole basis for a
became widespread during the late            sion. Their efforts resulted in a document        DEA investigation. The interim
1990s. In 2001, Glen A. Fine, the in-        called “Prescription Pain Medications:            statement, on the other hand, lists all
spector general of the Department of         Frequently Asked Questions for Health             these factors as potential indicators of
Justice, accused the DEA of not doing        Care Professionals and Law Enforcement            diversion that could trigger an investiga-
enough to combat illegal prescription        Personnel.” Routinely called the FAQ,             tion. Another key change involves
drug use, which he claimed was even          the document was published in hardcover           opioid refills. The FAQ sanctioned the
more prevalent than the abuse of co-         form and on the DEA’s Web site in                 practice of writing multiple prescriptions
caine. In response to these charges, the     August 2004.                                      on the same day for future refills on
DEA in that same year released a four-           “We thought this was a watershed              different days. However, the interim
part action plan to stem the flow of          event,” recalled Portenoy, who spent              statement identifies this as a recurring

554        NEWS                                                       Journal of the National Cancer Institute, Vol. 97, No. 8, April 20, 2005
tactic among physicians who divert                 named William Bergman, was also tried
prescription drugs into illegal markets.           by Tucker.)
Paice says physicians often write                      California now mandates that
multiple prescriptions at once for                 physicians undergo 12-hour continuing
frail and elderly patients to minimize                                         medical educa-
their travel. “But the [interim                                                tion for pain
statement] claims you can’t do that,”                                          management
she said. “That means the patient                                              every year.
has to drive to the hospital to get                                            Michigan and
that prescription.”                                                            West Virginia
    Libby suggests that the DEA’s focus                                        had adopted
on practitioners is misplaced. In his                                          similar policies
view, the real sources of diversion are                                        in a trend that
wholesalers, drug store robberies, and                                         Tucker hopes
online pharmacies that operate on the                                          will continue
fringes of the law, often outside the              Kathryn Tucker              to grow.
United States. But “in some cases,” he                                         “Inadequate
conceded, “pain patients will scam their           education surrounding pain is a huge

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own doctors … . That’s a major source              and pervasive problem,” she said.
of diversion: These patients will get              “I’ll tell you anecdotally, when you
their drugs, take some of them, and sell           sit across the table from a defendant
the rest. And that’s how the DEA will              during a deposition and ask about his
build a case—they go from the patient              training in pain management, and he
to the doctor.”                                    answers, ‘an oncology course in medi-
    In light of this view, Philip Cifarelli,       cine 30 years ago and a brown-bag
M.D., J.D., a physician who practices              lunch,’ you practically fall off your
law in Santa Ana, Calif., argues that              chair,” she said.
physicians can protect themselves by                   Tucker’s approach is to use the tort
carefully documenting opioid prescrip-             system to advocate for improved pain
tions on a patient’s medical record.               management. Portenoy, who emphasizes
“When the chart is well documented,                that physicians in general do not like tort
it’s a non-issue with the DEA,” he said.           as a tool for health care reform, concedes
“Problems happen when there’s no                   that findings against egregious offenders in
rationale as to why these medications              pain care are a wakeup call for the entire
were prescribed.”                                  community. “No one wants a flurry of
                                                   lawsuits,” he said. “But among the group
Lawsuits and Pain Management
                                                   I hang out with, the reality of having
   If there’s a view that the DEA and              these cases go forward successfully was
physicians both share, it’s that termi-            met with some sense of satisfaction.”
nally ill patients nearing the end of life             Moving forward, issues concerning
should not be denied adequate pain                 pain management will likely gain in pro-
treatment. Lester Tomlinson was an 85-             file. According to Portenoy, medical
year-old man with mesothelioma whose               schools and residency programs now
requests for painkillers went unheeded             view education about pain and its treat-
during the last weeks of his life at a             ment as a critical and unmet need. “What
nursing home in Northern California.               we [also need] is a rekindling of the
Tomlinson died in agony on Feb. 12,                events in the early 2000s,” he added.
2001. Soon after, Kathryn Tucker, J.D.,            “That’s when the DEA was reaching out
director of legal affairs with Com-                to the medical community in a search for
passion and Choices, an end-of-life                balance regarding ways to both treat pa-
advocacy group based in Seattle, sued              tients and minimize the risk of diversion.
Tomlinson’s doctors for inadequate                 We need to get the DEA and the state
pain management and won—only the                   medical boards and law enforcement
second time such a case had been                   together to support an initiative that will
successfully tried. (The first, also involv-        remove barriers to more effective care.”
ing an 85-year-old lung cancer patient                                    —Charles Schmidt

Journal of the National Cancer Institute, Vol. 97, No. 8, April 20, 2005                          NEWS   555