Professional casualties
in America�s war on drugs
By DAVID B. BRUSHWOOD
Am J HealthSyst Pharm. 2003; 60:2004-6
The metaphor of warfare has frequently
been used in descriptions
of government actions to
'combat' the scourge of drug abuse
in American society. As in any war,
there is 'collateral damage' to innocent
victims. The 'war on drugs' has,
at times, victimized pain patients and
those physicians and pharmacists
brave enough to meet patients' needs
for high doses of opioid analgesics. A
recent case from California serves as
a chilling example of how misguided
law-enforcement authorities can
confuse pain management with drug
diversion.
Background
On February 18, 1999, a Shasta
County, California, physician was arrested
at his community health clinic.
A local pharmacist and his wife were
also arrested at their pharmacy. Physician
Frank Fisher, Pharmacist Stephen
Miller, and Madeline Miller were all
charged with three counts each of first-degree
murder. Two additional counts
each of first-degree murder were later
added to these charges. Bail was set at
$15 million for Fisher and $3 million
each for the Millers.
California Attorney General Bill
Lockyer, commenting on the arrests,
used language usually reserved for
dramatic busts of large illicit drug
rings.
"We are prosecuting what was
a highly sophisticated drug-dealing
operation," he said "We are shutting
down suppliers of a highly addictive drug that has been improperly allowed
to saturate the community."1
The authorities were apparently
concerned by large amounts of opioids
and other controlled substances
being prescribed and dispensed by
Fisher and Miller. They were also
suspicious of the high doses being
prescribed. This concern existed despite
language in California law stating,
"A physician who uses opiate
therapy to relieve severe chronic intractable
pain may prescribe a dosage
deemed necessary to relieve severe
chronic intractable pain."2
Reports of
drug overdoses treated in area emergency
departments had led to the belief
that Fisher and Miller were illegally
diverting controlled substances.
Madeline Miller was a pain patient
of Fisher's and a pain advocate in
Shasta County. She aggressively fought
for the rights of patients when Medi-Cal
disallowed payment for pain medications
and other drugs. Serving as a
supposed 'link' between her physician
and her pharmacist husband, and
through zealous advocacy for those
whose condition was similar to her
own, Madeline Miller put herself on
the radar screen of agents who were
suspicious of Fisher's practices.
Stephen Miller was a community
pharmacist who had practiced in vari
ous settings since his graduation from
Oregon State University. Shasta Pharmacy
was located in a corner of what
had once been a grocery store. After
the grocery store moved out, the pharmacy
was left by itself in a large building,
isolated from the former grocery
area by a chain-link fence. His wife's
chronic pain condition, and his caring
approach to practice, led him to be
particularly sympathetic to the needs
of patients in pain.
After graduating from Harvard
Medical School, Frank Fisher worked
in various settings in underserved
communities, including Indian reservations.
The clinic he established in
Shasta County was not intended to
be a pain clinic. It served the needs of
all patients and employed various
therapists to supplement the medical
care provided by Fisher. Because he
was willing to use the 'principle of
titration'3 in his dosing of opioids to
the level needed for effective analgesia
without adverse effects, Fisher
found himself caring for many patients
in severe pain.
Legal case
Physicians and pharmacists
charged with major felonies in small
communities usually do not have the
benefit of a defense led by an experienced
trial attorney who is knowledgeable
about drug use and abuse.
The Fisher�Miller case was different.
Through family contacts, Fisher
arranged representation by Patrick
Hallinan of San Francisco, a leading
criminal defense lawyer whose previous
clients include author Ken Kesey,
the Soledad Seven, and Black Panther
Eldridge Cleaver.
The defense of the case focused on
Fisher's medical practice. If insufficient
evidence were shown to charge
Fisher with murder, then this conclusion
will also be reach for the Millers.
Preliminary hearings ordinarily
last only a few hours. A long preliminary
hearing usually lasts two to
three days. The preliminary hearing
for Fisher and the Millers lasted five
months, during which seven weeks of
testimony was given. The hearing
was so long because the judge had
other matters to address on many
days of the week, as did the attorneys.
Fisher and the Millers remained in
jail the entire time.
Very early in the preliminary
hearing, the tone was set when a star
witness for the government, a pain-management
expert who was critical
of numerous clinical judgments
made by Fisher, said, "The absolute
numbers don�t bother me a bit. I'll
repeat that. The absolute numbers
don't bother me a bit. I have cases of
my own that I can show on higher
doses than any patient Dr. Fisher ever
had in all the records that I've got."
Another expert testified she believed
Dr. Fisher's doses to be lethal, but she
later admitted that she enforces a "no
narcotics" policy in her clinic and has
no training in pain management.
Hallinan's experience led him to
believe that the government had
probably conducted "sting" operations
on Fisher, sending to him informants
pretending to be in pain
and trying to trick him into prescribing
them opioids they did not need.
Yet no evidence of such operations
was presented by the government.
When Hallinan inquired of witnesses
regarding such sting operations, his
suspicions were confirmed. On at
least seven occasions, Fisher had
been challenged to inappropriately
prescribe for informants, and he had
refused every time.
One of the five people allegedly
murdered by Fisher and the Millers
was a pain patient who had been a
passenger in a tragic automobile accident.
She suffered multiple massive
trauma to her brain and other vital
organs. Because the coroner detected
oxycodone in her tissues at the time of
her violent death, the conclusion was
that Fisher and the Millers had murdered
her. Another alleged murder
victim was not a patient of Fisher or
the Millers but had died from abusing
medications stolen from a Fisher/
Miller patient by a friend.
As the government's testimony
progressed through the preliminary
hearing, and as Hallinan elicited recantations
and admissions from
those testifying, the media coverage
began to shift. Although the deputy
attorney general continued to refer
to the defendants as street pushers,
the media reported that the husband
of one alleged murder victim was actively
raising money to fund the defense.
"They gave my wife 18 months
to live 4 years ago," he said. "She
lived 4 years because of Frank. He got
her out of bed."4
Another story reported
that Fisher lived frugally, that
he rented his home and drove a 20-
year-old car, and that he had spent
20 years treating indigent patients.
Medical experts were quoted explaining
that there is no standard upper
limit on opioid doses applicable
to every patient and that prosecutions
of pain management practitioners
have a "chilling effect" on the
provision of necessary medications
to chronic pain patients.5
At the end of the preliminary
hearing, the judge had heard what he
needed to know. All murder charges
against Madeline Miller were dismissed
and she was released. The
murder charges against Fisher and
Stephen Miller were reduced to manslaughter.
Bail for Fisher and Stephen
Miller was reduced from millions to
zero. They were released on their
own recognizance, subject to the
condition that they not practice
medicine or pharmacy until the matter
was resolved.
For three and one-half years Fisher
and Miller watched the legal process
grind itself out through meetings,
delays, and court appearances. On
January 14, 2003, just shy of four
years since their arrest, the remaining
manslaughter charges against Fisher
and Stephen Miller were dismissed
when the deputy attorney general admitted
to the judge that the state
lacked sufficient evidence to proceed
with trial. The deputy attorney general
promised that the criminal
charges would be refiled within two
weeks. But months have passed and
that has not happened. Fisher and
Miller still have matters to clear up
regarding their medical and pharmacy
licenses. They hope to re-establish
their practices soon.
Discussion
There is a constant balancing act
in the regulation of controlled substances,
because regulation that is
too strong will restrict access to appropriate
medications for legitimate
medical needs, while regulation that
is too lax will permit diversion of
prescription drugs to illicit use. The
goal of regulation is to prevent diversion
without restricting pain management
or other appropriate patient
care. To do this, practitioners and
regulators have tried to create a "safe
harbor" for pain management practice,
outside the storm of drug-control
suspicion, distrust, and enforcement.
It isn't working.
The enactment in many states of
legislation called the Intractable Pain
Act has produced sympathetic and
compassionate ink-on-paper, but the
policies and procedures of law enforcement
have been largely unaffected.6
On the bright side, many
state boards of medicine and pharmacy
have taken to heart the provisions
of the 'Model Guidelines for
the Use of Controlled Substances in
the Treatment of Pain.'7 These agencies
are no longer the everyday threat
they once were, but in some states they
continue to harass their own licensees.
It is a confusing situation for regulators
and law enforcement. 'Addiction'
and 'physical dependence'
may seem similar to some, but they
are in fact very different. Legitimate
pain patients who become physically
dependent on opioids will freely, but
incorrectly, admit to being addicts.
Despite the absence of any law forbidding
prescribing or dispensing of opioids
to addicts who are in pain, and
despite the fact that pain patients do
not meet the diagnostic criteria for addiction,
law enforcement officials
reach the horrifying (to them) conclusion
that physicians and pharmacists
who supply opioids to chronic pain
patients are supporting addiction.
Concerns among officers of the
law are understandably increased
when they discover that drug diverters
lie to physicians and pharmacists,
sometimes very well and very successfully.
The authorities also know
that employees of physicians and
pharmacists steal drugs and prescriptions
and that rogue employees
fraudulently authorize access to
medication by people who have no
legitimate need for it. On occasion,
legitimate patients, and their friends
and family, sell their medication because
it is of value and because they
are in dire economic circumstances.
Given these realities, it is perhaps understandable
that law enforcement
authorities see physicians and pharmacists
as the prime culprits in the
diversion of controlled substances.
At first blush, the solution to this
misunderstanding is simple. Increasing
communication between health
care and law enforcement should
avoid 'false-positives,' in which pain
patients are mistaken for drug diverters,
as well as 'false-negatives,' in
which drug diverters are given access
to drugs they should not have. But
there are barriers to increased communication.
There are reasons why
health care providers and law enforcement
do not consult with each
other immediately when something
seems amiss. A legacy of distrust
makes health care providers reluctant
to draw attention to themselves
and perhaps implicate themselves in
wrongdoing by requesting a consultation
with an enforcement official.
In law enforcement, the focus is on
catching criminals, not on teaching
criminals how to avoid being caught.
Early consultations are contrary to
the culture of discreet surveillance
and massive force when the time is
right.
Somehow this stalemate must be
broken. The Fisher Miller case is
not unique. Physicians Stan Naramore
(Kansas), Jong Bek (Indiana)
and Robert Weitzel (Utah) have all
been charged with murder in the
deaths of pain patients and subsequently
absolved of the charges. Physician
James Graves (Florida) was
charged with murder and convicted
of manslaughter. His appeal will be
heard soon. Physicans Spurgeon
Green (Georgia), Denis Deonarine
(Florida), and Jesse Henry (New
Mexico) are all facing murder charges
in the alleged deaths of their
patients from the toxic effects of prescribed
opioid analgesics. Many other
physicians and pharmacists are
facing lesser criminal charges.8
The
radical approach of permitting
health professionals to continue to
practice despite concerns, and waiting
for the opportunity to charge
them with serious criminal violations,
threatens the quality of both
medical care and law enforcement.
A stepwise approach to regulatory
oversight of pain management practice
seems needed. When suspicions
first arise that a physician or a pharmacist
may be inappropriately prescribing
or dispensing and that
diversion may be occurring, law enforcement
could offer a diversion
consultation. If the problem is not
resolved, then investigators could
test the practice through informants
posing as pain patients. If drugs are
prescribed and dispensed to informants,
then an expert panel of peers
could determine whether any standard of care is being followed. If no
standard of care is being followed,
then a second expert panel could determine
whether patients have died
as the result of drug use. Only if the
inquiry reaches this stage and if the
answer is yes would the matter proceed
to criminal prosecution. Otherwise,
the physician or pharmacist
would be permitted to continue to
practice, perhaps on the condition that
appropriate continuing-education
programs be completed.
One day there may be a technological
diagnostic method of differentiating
legitimate pain from substance
abuse or diversion. Just as laboratory
values and certain types of
imaging can facilitate other diagnoses,
the best answer may eventually
lie in some as yet undiscovered objective
test.
For the present, health
care professionals and law enforcement
officials will simply have to find
ways to work together better, and
legislatures must provide a statutory
framework for that to occur.
The
Fisher/Miller case is an extreme example
of a common problem. It is a
case of a system-related errors from
which lessons must be learned and
improvements made to prevent similar
errors in the future.
References1. Geissinger S. Attorney general announces arrest
of pharmacy owners. Sacramento, CA:
Associated Press State and Local Wire; 1999
Feb 19.
2. Cal. Bus. & Prof. Code �2241.5 (2002).
3. Portenoy RK. Opioid therapy for chronic
nonmalignant pain: clinicians� perspective. J
Law Med Ethics. 1996; 24:296-309.
4. Doctor charged with killing patients says he�s
innocent, could be linked to others. Redding,
CA: Associated Press State and Local Wire;
1999 Mar 8.
5. Hall C. Prosecutors raise Shasta County toll
as painkiller-murder hearing opens. San
Franc Chron. 1999; Apr 28:A6.
6. Ziegler SJ, Lovrich NP. Pain relief, prescrip-tion
drugs, and prosecution: a four-state sur-vey
of chief prosecutors. J Law Med Ethics.
2003; 31:75-100.
7. Federation of State Medical Boards of the
United States. Model guidelines for the use of
controlled substances in the treatment of
pain. www.fsmb.org (accessed 2003 Aug 28).
8. Association of American Physicians and Sur-geons.
Actions against pain physicians. www.
aapsonlin.org/painman/actionsagainst.htm
(accessed 2003 Aug 28).
David Brushwood is Professor of Pharmacy Health Care Administration at the
University of Florida in Gainesville. He is a Mayday Scholar with the
American Society of Law, Medicine and Ethics (ASLME).
For information about ASLME pain policy projects, go to ASLME.