[Federal Register Volume 64, Number 89 (Monday, May 10, 1999)]
[Notices]
[Pages 25073-25080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-11580]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 96-41]
Paul W. Saxton, Continuation of Registration
On July 15, 1996, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA) issued an
Order to Show Cause to Paul W. Saxton, D.O. (Respondent) of Sandy,
Utah, notifying him or an opportunity to show cause as to why DEA
should not revoke his DEA Certificate of Registration AS9420059 and
deny any pending applications for renewal of such registration as a
practitioner pursuant to 21 U.S.C. 823(f) and 824(a)(4), for reason
that his continued registration would be inconsistent with the public
interest.
[[Page 25074]]
By letter dated August 15, 1996, Respondent, through counsel, filed
a request for a hearing, and following prehearing procedures, a hearing
was held in Salt Lake City, Utah on March 4 through 7, 1997; March 17
through 19, 1997; and June 23 through 27, 1997, before Administration
Law Judge Gail A. Randall. At the hearing, both parties called
witnesses to testify and introduced documentary evidence. After the
hearing counsel for both parties submitted proposed findings of fact,
conclusions of law and argument. On October 6, 1998, Judge Randall
issued her Opinion and Recommended Rulings, Findings of Fact,
Conclusions of Law and Decision, recommending that Respondent's DEA
Certificate of Registration be continued with no adverse action being
taken. No exceptions were filed by either party to the Administration
Law Judge's Decision, however on November 5, 1998, Respondent filed an
Application for Attorney's Fees and Expenses. Thereafter, on November
19, 1998, Judge Randall transmitted the record of these proceedings to
the then-Acting Deputy Administrator.
The Deputy Administrator has considered the record in its entirety,
and pursuant to 21 CFR 1316.67, hereby issues his final order based
upon findings of fact and conclusions of law as hereinafter set forth.
The Deputy Administrator adopts, in full, the Recommended Rulings,
Findings of Fact. Conclusions of Law and Decision of the Administration
Law Judge. His adoption is in no manner diminished by any recitation of
facts, issues and conclusions herein, or of any failure to mention a
matter of fact or law.
As a preliminary matter, the Deputy Administrator finds that
Respondent's Application for Attorney's Fees and Expenses filed on
November 5, 1998, was premature. Pursuant to 5 U.S.C. 504 and 28 CFR
24.101, et seq., such a request may only be filed after a party has
prevailed in an action brought by DEA. Since this final order is the
final agency action in this matter, Respondent's request was premature
and is therefore denied.
The Deputy Administrator finds that Respondent has been practicing
osteopathic medicine since 1979, and since about 1990, the primary
aspect of his practice has been the treatment of pain.
The Utah agency responsible for issuing licenses to professionals
received complaints concerning Respondents in July 1988, January 1989
and August 1993. Following an investigation of these complaints, no
action was taken against Respondent. Respondent however did admit that
he prescribed anabolic steroids for muscle enhancement until sometime
in 1992. In 1992 he was told by state and Federal investigators that
this practice became illegal in the State of Utah in 1990 and federally
in February 1991. There is no evidence that Respondent has prescribed
anabolic steroids for muscle enhancement after being advised that such
practice was illegal.
In January 1994, the state agency received a complaint from a
pharmacist that Respondent had prescribed six different controlled
substances to one individual on January 10, 1994. As a result, the
state agency and DEA initiated an investigation of Respondent.
Investigators obtained patient prescription profiles from local
pharmacies. Then on November 30, 1995, the investigators executed an
administrative inspection warrant at Respondent's office during which
the investigators seized 38 patient charts. Also during execution of
the administrative inspection warrant it was discovered that Respondent
has purchased controlled substances but had not maintained a log or
other record, other than the patient charts, indicating the disposition
of the drugs, nor had Respondent conducted a biennial inventory of the
controlled substances that he had purchased.
Next, the Government had an expert in pain management and the
proper use of controlled substances review 18 of the 38 patient medical
records that were seized from Respondent's office. After reviewing
these records the Government's expert concluded that there are
``consistent patterns supporting the contention that [Respondent] has
been inappropriately and excessively prescribing controlled substances,
particularly opioids.''
Since Respondent's patients that are at issue in this proceeding
were supposedly being treated by Respondent for chronic pain, there was
extensive evidence presented by both the Government and Respondent
regarding the treatment of chronic pain patients. The Government's
expert defined chronic pain as ``pain which has been present for over 6
months.'' He stated that pain is subjective and therefore a physician
has to rely on a patient's complaints of pain. He further stated that
the source of an individual's pain may never be identified. The
Government's expert acknowledged that using opioids to relieve chronic
pain is a legitimate medical practice and that some patients may
require opioids for the rest of their lives to control chronic pain. He
testified that once a diagnosis was made, a physician should start with
the most benign medications at the least dose and increase the dose or
change the medication as needed. According to the Government's expert
there does not appear to be an arbitrary upper dosage limit for most
opioids, however increasing dosage levels may not be appropriate if the
pain is not responding to the opioids because ``[m]any types of pain
are not responsive to opioids. * * * Regardless of what dose.''
Nevertheless the Government's expert testified that:
[M]ost chronic pain patients are never going to be pain free. *
* * But I think if their pain is managed at a level where they can
function where the pain isn't a big issue in their life anymore,
then that's considered reasonable control. * * * [But] there are a
lot of other treatment options that would be used before opioids
would be tried.
Two experts testified on behalf of Respondent. The first, an expert
in family practice with chronic pain patients comprising the
predominant portion of his practice, defined intractable pain as
``[p]ain that has resisted all reasonable efforts to eliminate the
source or to eliminate the symptoms.'' He testified that there is no
ceiling on the use of controlled substances in the treatment of chronic
pain, and that the dosage and length of therapy are irrelevant as
measurements to determine the quality of medical treatment received by
chronic pain patients. This expert further testified that a physician
should not reduce the levels of a patient's medications if the
patient's pain is being managed, and that it is appropriate to
prescribe combinations of controlled substances since different
medications work for different levels of pain and there are varying
effective time spans for various medications. It was the opinion of
this expert that physicians are afraid to prescribe narcotics for fear
of prosecution by regulatory agencies.
Respondent's other expert witness was qualified as an expert in
family practice with a subspecialty in pain management and opioid
treatment. He has published numerous articles regarding the treatment
of chronic pain patients. According to this expert, there is a
difference of opinion on the medical profession regarding the use of
opioids in the management of chronic pain, with two differing
approaches classified as the therapeutic school, to which Respondent
and his experts belong, and the dependency school, to which the
Government's expert belongs. The field of pain management is a
controversial issue with the treatment policy evolving within the
medical profession.
According to this expert, the measure of successful treatment of a
chronic pain
[[Page 25075]]
patient is whether the patient has experienced an increase in his/her
level of comfort and function and has an improved quality of life. A
physician has to trust his/her patient and individualize the treatment.
There is no ceiling or upper limit on the use of opioids and in
determining whether a dosage level is adequate for a chronic pain
patient one should not look at the number of pills consumed, but should
look at the functioning level of the patient. The expert further
testified that prescribing combinations of drugs meets the standards of
the therapeutic school since a patient might use one type of drug for
light pain and another type for more severe pain.
Respondent also introduced into evidence a copy of a document
written in 1997 by the American Academy of Pain Medicine (AAPM) and the
American Pain Society (APS) entitled ``The Use of Opioids for the
Treatment of Chronic Pain,'' (hereinafter referred to as ``Consensus
Statement''). One conclusion of the Consensus Statement is that
``[p]ain is often managed inadequately, despite the ready availability
of safe and effective treatments,'' because impediments ``to the use of
opioids include * * * fear if regulatory action.'' The Consensus
Statement also provided guidance for regulatory agencies for
determining accepted principles of practice for the use of opioids for
chronic pain patients. The Consensus Statement indicated that in
initially evaluating a patient a complete history and physical
examination should be conducted. The treatment plan should be
individualized and should include different types of treatment
modalities. Consultation with a specialist in pain medicine or with a
psychologist may be warranted. The Consensus Statement further provided
that ``[t]he management of pain in patients with a history of addiction
or a comorbid psychiatric disorder requires special consideration, but
does not necessarily contraindicate the use of opioids.'' Review of
treatment efficacy should occur periodically and complete documentation
is essential.
Respondent testified that his treatment objectives for his chronic
pain patients are (1) to improve the patient's quality of life; (2) to
increase the patient's level of comfort; and (3) to increase that
patient's ability to function. He further testified that when he
diagnoses a patient with chronic pain, he uses the ``stepladder
approach'' to prescribing medication, starting with noncontrolled
substances, then Schedule III and IV controlled substances, and then if
necessary Schedule II controlled substances. In treating his chronic
pain patients, Respondent also uses other modalities in conjunction
with his prescribing of controlled substances.
After reviewing the 18 patient records, the Government's expert
provided an opinion regarding the appropriateness of Respondent's
prescribing of controlled substances for each patient and regarding a
number of general inadequacies he found in Respondent's treatment of
his chronic pain patients. However, in rendering this opinion the
Government's expert did not examine any patient personally; did not
interview any of the patients; did not obtain a medical history; and
did not discuss the information in the charts, or the lack therefor,
with Respondent, the treating physician.
According to the Government's expert, Respondent's treatment of the
patients was inadequate because the patients entering into treatment
with Respondent received inadequate evaluations and diagnosis, since
Respondent provided a general physical examination rather than an
examination tailored to the patient's specific pain complaint. However,
the Government's expert admitted at the hearing that he could not
decipher the meaning of some of Respondent's abbreviations found in the
patient records. The Government's expert was also of the opinion that
Respondent's treatment was inadequate because he simultaneously
prescribed similar medications without medical justification, allowing
the patient to determine which of the overlapping medications to take,
and he made no attempt to reduce or control medication doses responsive
to the patient's condition. In addition, Respondent prescribed
controlled substances to several patients known by him to have ongoing
substance abuse or psychiatric problems, with some patients actually
having recently completed substance abuse treatment, which according to
the Government's expert made continued controlled substance use
suspect. Further, the Government's expert found that if Respondent's
prescribing of controlled substances for family members was not
blatantly illegal, it was at least ethically prohibited. The
Government's expert also concluded that Respondent appeared reluctant
to seek help from other medical specialists outside of his area of
expertise; failed to correlate treatment with the patient's improvement
or lack of improvement; and failed to use other modes of treatment
other than prescribing controlled substances.
The Government's expert testified that based upon his review of the
patient records, ``I do not believe that there was sufficient diagnosis
or basis for the prescribing of the substances prescribed by
[Respondent].''
Respondent's first expert reviewed Respondent's patient charts,
read the report of the Government's expert, and discussed the patient
charts with Respondent. He concluded that in his opinion, Respondent
was thorough in his diagnosis, that he adequately examined the
patients, and that he had maintained adequate charts. In his opinion,
Respondent's prescribing was well within the standards of reasonable
medical care; his monitoring of the patients' medications was adequate;
his evaluation of each patient on a regular basis was adequate; and his
prescribing of narcotic analgesics was forlegitimate clinical reasons.
Respondent's other expert testified concerning Respondent's
treatment in general and specifically regarding Respondent's treatment
of eight of the patients at issue. In rendering his opinion, he
reviewed the patient charts and discussed the patients' treatment with
Respondent. According to this expert, Respondent met the standard of
care in his treatment under the therapeutic school treatment approach
for chronic pain patients. However, the expert acknowledged that
Respondent's practices were not without flaws. In his opinion,
Respondent did not document his initial findings regarding the medical
history and physical examination in the recommended detail when making
his chronic pain diagnostic evaluation of his patients; he did not
consistently consult previous treating physicians; while he discussed
the risks with his patients, to include acetaminophen toxicity, he did
not chart the possible side effects in all of the medical records; and
although he did consult with specialists in many instances, Respondent
could have utilized consultants more consistently in his patients'
care. During his testimony, this expert stressed the need for thorough
documentation stating that ``there should be clear-cut indications in
the medical record that [the patient's] function is better with the
medications. And if it's not, then the doctor puts himself at risk if
he doesn't document sufficiently in the record that the patient
actually is doing better.''
However, this expert also testified that Respondent had a working
diagnosis for each patient which justified the prescribed medications;
had an adequate treatment plan documented in his patient charts; saw
his patients frequently to monitor their progress; prescribed
controlled substances in compliance with applicable law; and maintained
quite
[[Page 25076]]
adequate records after the sparse initial visit entries. He further
testified that in his opinion, Respondent's prescribing practices were
appropriate.
In her Recommended Rulings, Findings of Fact, Conclusions of Law,
and Decision, Judge Randall went into great detail regarding the
medical problems and treatment of the patients at issue in this
proceeding. She discussed the prescription profiles, the information
contained in the patient charts, the experts' testimony, Respondent's
testimony, and the testimony of some of the patients. Since the Deputy
Administrator is adopting Judge Randall's findings of fact in their
entirety, there is no need for him to reiterate them. However, the
Deputy Administrator makes the following general findings regarding
Respondent's treatment of the patients at issue.
In general, the patients at issue suffered from a variety of
problems including headaches, low back pain, pain in other parts of
their bodies, sleep disturbances, multiple sclerosis, and depression.
These patients were seen by Respondent at least monthly, and sometimes
weekly. At virtually every visit, they were prescribed a combination of
several different controlled substances, as well as other medication.
Respondent explained the use of these medications, warned of the
dangers of misusing the medications, and adjusted the medication
regimen periodically to find the best combination of drugs. In
addition, these patients received other forms of treatment such as
osteopathic manipulations, traction, physical therapy, trigger point
injections, range of motion exercises, transcutaneous electric nerve
stimulation, and training in the proper use of body mechanics.
Respondent prescribed large quantities of controlled substances to
these patients on a regular basis; however, he appeared to monitor his
patients' use of the medications. He would not refill a prescription
without seeing the patient. If Respondent became concerned about the
amount of controlled substances being consumed by a patient, he would
evaluate whether the patient appeared coherent and able to function.
Respondent would perform liver toxicity tests to determine whether a
patient was consuming too much acetaminophen and when a patient would
experience a side effect from a drug, Respondent would discontinue the
medication. Respondent assisted one patient in tapering off all
medication, however the patient's pain became intolerable and
Respondent resumed prescribing controlled substances for the patient.
A couple of the patient charts indicate that Respondent performed
an impairment evaluation using the American Medical Association
guidelines. Respondent also referred many of these patients to
specialists, such as neurologists or psychiatrists, or to pain clinics.
For the most part, these specialists confirmed Respondent's diagnosis,
however, several of the specialists expressed concerns regarding the
amount of controlled substances being prescribed by Respondent to the
patients. Reports from these specialists, including those that
expressed concerns, are included in the patients' charts. Two of
Respondent's patients were referred to the pain clinic where the
Government's expert was the medical director. In neither instance did
the Government's expert contact Respondent to learn of the patient's
history, however the Government's expert testified that there was no
medical standard requiring such contact. One patient left the clinic
because he could not afford to continue his treatment there. The other
patient was tapered off his medication while at the clinic, but when
the clinic could not manage the patient's pain, he was put back on
narcotics. According to this patient, the clinic encouraged extensive
daily exercise and meditation, however he further testified that this
was not realistic if one has a job given the time constraints.
According to the Government's expert there were a number of ``red
flags'' in Respondent's charts which should have alerted Respondent to
the fact that these drugs were not being used for a legitimate medical
purpose. First, some patients were involved in a number of accidents,
however Respondent was not always told of them. On one occasion, a
patient was arrested for driving under the influence of drugs.
Respondent regulated the patient's medication, but after the patient's
second arrest, Respondent refused to prescribe any more medication
unless the patient signed a written promise not to drive while taking
the medication. Second, a number of the patients were being treated by
other doctors. In some of these instances, Respondent was not aware of
the other doctors' treatment. According to Respondent and the patients,
if he was made aware of the other treatment, he would discuss the
situation with the patients and indicate that they could have only one
treating, physician. Third, on several occasions' Respondent was
contacted by pharmacists, a home health care nurse and/or insurance
carriers regarding the large amount of controlled substances being
prescribed to patients. Respondent credibly testified that he took
these concerns into consideration when treating the patients. Fourth,
one of Respondent's patients was sharing drugs with a family member and
another with a friend. Also two of Respondent's patients had allegedly
altered prescriptions. With all of these patients, Respondent advised
them that this behavior was unacceptable and if it continued they would
no longer be his patients. In fact, Respondent did ultimately stop
treating one of them. Fifth, the spouse of one of Respondent's patients
told Respondent of her husband's past drug problems and that he faked
pain and exhibited drug seeking behavior. Respondent met with the
patient and his wife to discuss this situation and determined that the
patient had chronic pain and needed the medication. Respondent's expert
testified that a family member's concerns should be addressed, but
often a family member needs to be educated that just because a person
is taking a large number of controlled substances does mean that the
person is an addict or abuser. Sixth, one of the patient charts
indicated that the patient lost several prescriptions, however Judge
Randall found that the patient credibly testified that he never lied to
Respondent in order to obtain more prescriptions. Seventh, Respondent
resumed prescribing controlled substances to a patient after he
completed drug detoxification treatment. According to Respondent, he
evaluated the patient and determined that he still suffered from
chronic pain and needed the medication. Finally, one of Respondent's
patients was hospitalized for an amphetamine overdose. Respondent's
expert testified that this was a ``big red flag'' but if the patient
had chronic pain, she was entitled to relief.
The concerns of the Government's expert have been discussed
generally above. The Government's expert expressed specific concerns
regarding each of the patients. Most notable is the expert's
disagreement with Respondent's continued prescribing of acetaminophen-
based products to a patient who developed hepatitis. In fact,
Respondent's expert indicated that he would have altered the
prescriptions for this patient once it was learned that she had
hepatitis.
As discussed above, one of Respondent's experts found that
Respondent's patient chart were lacking details regarding his initial
evaluation and diagnosis, however the expert found Respondent's
treatment reasonable and prescribing appropriate.
[[Page 25077]]
The expert found that the prescribing of a combination of drugs at the
same time is appropriate because each drug has specific indications.
The expert also opined that prescribing beyond the recommended doses
found in the Physician's Desk Reference (PDR) is not acting outside the
standard of care because the PDR is merely a guide.
A number of Respondent's patients testified at the hearing in this
matter. In addition, Respondent introduced letters from 99 of
Respondent's patients. Essentially, these patients indicated that
before seeing Respondent they could not function due to their chronic
pain. Some indicated that they had been to other doctors but nothing
worked to relieve them of their pain. However, they all indicated that
due to Respondent's treatment, including the prescribed medications,
their level of comfort has increased and their quality of life has
improved. Some indicated that they were now able to work full-time and
others indicated that they were able to participate in family
activities and life in general. Several of the patients indicated that
they had stopped taking medications for a period of time, but the pain
was intolerable and they had to resume taking narcotics prescribed by
Respondent. One patient indicated that it was his goal to ultimately be
drug-free, but he does not want to be drug-free and disabled. Regarding
the combination of prescriptions issued by Respondent, a number of the
patients stated that they take different drugs depending on the
severity of the pain and never take the drugs simultaneously. In
addition, a number of patients indicated that Respondent did not tell
them to take their prescriptions to different pharmacies to avoid
suspicion. In fact, Respondent encouraged them to establish a
relationship with one pharmacy and take all of their prescriptions to
that pharmacy to be filled.
The Government also introduced into evidence at the hearing the
testimony of two pharmacists and statements from 13 other pharmacists
regarding their concerns about Respondent's controlled substance
prescribing. One pharmacist testified that Respondent's prescribing
placed the health and overall well-being of his patients at risk. He
was concerned about the number of prescriptions issued by Respondent,
the frequency of the prescriptions and the toxicity associated with
taking those prescriptions. He further testified that he filled the
prescriptions of other physicians who treat chronic pain, but they did
not write as many controlled substance prescriptions as Respondent. He
also indicated that when he expressed his concerns to Respondent
regarding prescriptions issued to three patients who lived together,
Respondent ``basically * * * told me that he was the doctor, I was the
pharmacist. * * * He was very flippant about the way that he told me
off, basically just to mind my own business, that I had no reason to be
calling him.'' The other pharmacist testified that he had concerns
regarding some of Respondent's prescriptions; that he contacted
Respondent regarding these concerns; but that he never refused to fill
any of Respondent's prescriptions.
As to 10 of the pharmacists' statements, the Deputy Administrator
agrees with Judge Randall's finding that they were ``(1) lacking in
foundational information about the declarants' credentials, (2) so
lacking in factual specificity about the events related, and (3) so
vague as to what was said to the Respondent and what he replied, that,
without the declarants' testimony and opportunity for cross-
examination, . . . these statements [are] worth very little weight in
this matter.''
The other three pharmacists' statements also lacked foundational
information about the pharmacists' credentials other than that they
were licensed at some point. One pharmacist expressed general concerns
about three specific patients and that these concerns were raised with
Respondent. However there was no information in this statement as to
when these concerns were raised with Respondent and what specifically
Respondent was told about the patients' behavior at the pharmacy.
Another pharmacist indicated that he no longer fills Respondent's
prescriptions, but he also indicated that he never called Respondent to
voice his concerns. This pharmacist also named a specific patient
however there was no other evidence presented linking this patient to
Respondent. The third pharmacist described his experiences with a
specifically named patient, however there was no evidence linking the
behavior of this patient with conduct by Respondent. As with the other
statements, Judge Randall concluded and the Deputy Administrator agrees
that these statements are entitled to little weight.
Respondent testified at the hearing about the pharmacists' concerns
stating that, ``The captain of the ship is the physician, the buck
stops here. I'm the ultimate individual because I'm the individual who
prescribes the medication. Therefore, I take into consideration what
the pharmacist says, but it's my responsibility to prescribe the
medication.''
Respondent acknowledged at the hearing that between December 1993
and September 1995, he had ordered multiple dosage units of controlled
substances that he either took himself or gave to family members for
their documented medical conditions, or that were to be used for
emergency situations in his office.
Respondent admitted at the hearing that in 1995 he had not
maintained a complete and accurate record in a formal log of controlled
substances he dispensed in his office, and that he had not taken a
biennial inventory of controlled substances prior to November 1995.
However, Respondent introduced evidence at the hearing that in December
1995, he began maintaining a log which reflects his controlled
substance dispensing, and he also introduced a copy of his in-office
inventory of controlled substances as of January 2, 1996.
A former member of the Utah medical examining board who was also
the president of the state osteopathic association from 1984 to 1991,
testified that he has known Respondent since 1974; that Respondent has
a reputation in the medical community as being skilled in the practice
of osteopathic medicine; that he has referred his patients to
Respondent for treatment; that it is appropriate for a physician to
maintain controlled substances in his office for treating family
members; and that Respondent's professional charges were reasonable
within thee osteopathic community.
Respondent testified at the hearing that between 1994 and 1997, he
took three courses on pain management which consisted of guest lectures
``who were considered `authorities' in the pain treatment and how these
individuals managed their chronic intractable pain patients.''
Pursuant to 21 U.S.C. 823(f) and 824(a)(4), the Deputy
Administrator may revoke a DEA Certificate of Registration and deny any
pending application for renewal of such registration, if he determines
that the continued registration would be inconsistent with the public
interest. Section 823(f) requires that the following factors be
considered in determining the public interest:
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(3) The applicant's conviction record under federal or state laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
[[Page 25078]]
(4) Compliance with applicable state, federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
These factors are to be considered in the disjunctive; the Deputy
Administrator may rely on any one or a combination of factors and may
give each factor the weight he deems appropriate in determining whether
a registration should be revoked or an application for registration
denied. See Henry J. Schwarz, Jr., M.D., 54 FR 16,422 (1989).
It is the Government's position that factors two, four and five
apply in this case. Because of his failure to keep proper records,
Respondent was unable to account for large quantities of drugs that he
had ordered. He prescribed large quantities of controlled substances to
individuals who he knew or should have known abused the drugs. In
addition, he prescribed controlled substances to patients without
adequate justification for the prescribing. Respondent ignored the
concerns of pharmacists and other health care professionals thereby
threatening his patients' health and safety. The Government further
argued that Respondent violated state law by prescribing controlled
substances for family members and by prescribing anabolic steroids for
muscle enhancement. It is the Government's position that Respondent's
cavalier attitude towards the handling of controlled substances places
his patients at risk.
Conversely, Respondent contends that the Government has failed to
establish a factual basis for the revocation of his DEA registration.
It is Respondent's position that there were problems with the
Government's investigation and that the Government's expert was not
provided adequate information in order to render a meaningful opinion
regarding Respondent's treatment of his patients. The Government took
38 out of over 500 patients charts and then only had its expert review
18 of the charts. The pharmacists' statements were too general to be
used against him. Also, the Government failed to link any patient abuse
of the prescriptions to any conduct, or lack thereof, by Respondent. It
is Respondent's position that he prescribed controlled substances to
his patients for legitimate medical purposes and that his failure to
maintain records in the form prescribed by DEA does not warrant
revocation in this case. Respondent contends that his medical practices
pose no danger to the public health and safety, but that his patients
will be in danger if his registration is revoked and they can no longer
obtain controlled substances to enable them to continue functioning as
productively as possible.
Regarding factor one, there is no evidence in the record that the
state licensing board has taken any action against Respondent's license
to practice medicine or handle controlled substances. Likewise
regarding factor three, there is no evidence in the record that
Respondent has been convicted of any controlled substance related
offense.
However, factors two and four, Respondent's experience in
dispensing controlled substances and his compliance with applicable
laws relating to controlled substances, are relevant in determining
whether Respondent's continued registration is in the public interest.
Pursuant to 21 CFR 1306.04, prescriptions for controlled substances
must be issued for a legitimate medical purpose by a practitioner
acting in the usual course of professional practice.
The Government alleged that Respondent's prescribing to the
patients at issue in this proceeding, as well as to his family members
was not for a legitimate medical purpose. First, in support of its
position the Government argued that Respondent's prescribing exceeded
the recommended amounts and length of time set forth in the PDR.
However, DEA has previously held that the PDR is not binding on a
physician. See Margaret E. Sarver, M.D., 61 FR 57,896 (1996). The
Deputy Administrator agrees with Judge Randall's conclusion that
exceeding the recommendations in the PDR may warrant further
investigation but it does not, in and of itself, make the prescriptions
not legitimate.
Second, the Government contended that there was inadequate
diagnosis and evaluation to justify Respondent's prescribing of
controlled substances. According to the Government's expert, there was
insufficient information in the patient charts to warrant the
prescriptions and Respondent did not refer the patients to specialists.
One of Respondent's experts agreed with the Government's expert
testifying that in his opinion the patient charts were lacking in
detail regarding Respondent's initial evaluation and diagnosis, and on
two occasions he would have referred the patients to specialists. But
Respondent's expert also testified that subsequent entries in the
patient charts were sufficient and that Respondent did refer other
patients to specialists. Judge Randall concluded and the Deputy
Administrator agrees that based upon a review of the patient charts, as
well as, Respondent's testimony, the patients' testimony and
statements, the experts' testimony, and reports from specialists found
in the charts, the preponderance of the evidence supports a conclusion
that the prescribing was justified.
Third, the Government argued that Respondent failed to reduce the
dosage levels prescribed and that his prescribing was not responsive to
the patients' medical conditions. All of the experts testified that
there is no upper limit on the use of narcotics in the treatment of
chronic pain. Respondent's experts testified that dosage levels should
not be reduced so long as the amount of drugs prescribed are
effectively managing the patient's pain; that Respondent's prescribing
was responsive to the patients' medical conditions; and that the amount
of pills prescribed alone should not be the test for determining
whether the prescriptions are legitimate. Rather, one should look at
whether the amount of drugs prescribed are enabling the patient to
function. Respondent monitored his patients' use of controlled
substances by seeing them at least monthly, and according to Respondent
none of his patients were over-medicated. There is no evidence in the
record that any of Respondent's patients were addicts. The term
``addict'' is defined in 21 U.S.C. 802(1) to mean, ``any individual who
habitually uses any narcotic drug so as to endanger the public morals,
health, safety, or welfare, or who is so far addicted to the use of
narcotic drugs as to have lost the power of self-control with reference
to his addiction.'' To the contrary, Respondent's patients testified
and/or submitted statements indicating that because of Respondent's
treatment they are able to be functioning members of society.
Fourth, the Government argued that Respondent improperly prescribed
controlled substances to patients who had recently completed substance
abuse treatment. But, the Government witness and the Consensus
Statement both indicated that it is not illegal to prescribe narcotics
to these patients, but that a physician should use extra caution in so
prescribing. The record indicates that Respondent evaluated these
patients and determined that they still suffered from chronic pain
requiring narcotics. Respondent monitored these patients' use of
controlled substances.
Fifth, the Government contended that Respondent improperly
prescribed controlled substances to family members. However, there is
no evidence that it is illegal to do so.
[[Page 25079]]
Finally, the Government argued that Respondent improperly
prescribed similar controlled substances simultaneously. But Respondent
testified that he uses the stepladder approach to prescribing
controlled substances. Therefore, he may prescribe a relatively weak
opiate and a stronger opiate so that he patient can take the medication
that correlates with his/her level of pain. Respondent's experts
testified that this approach to prescribing meets the standard of care
followed by the therapeutic school in the treatment of chronic pain.
Different drugs work differently for different people, and since pain
is subjective, the physician has to trust his patients.
The Government questioned the trustworthiness of a number of
Respondent's patients, including one who indicated that he lost
prescriptions; two who shared their drugs with others; those who went
to other doctors at the same time that they were being treated by
Respondent; and one whose spouse indicated that he faked pain to get
prescriptions. However, Respondent investigated the claims, discussed
the claims with the patients, made judgments as to whether or not to
believe the patients, and carefully monitored any future behavior.
The Deputy Administrator agrees with Judge Randall's conclusion
that based upon a review of the patient charts, Respondent's testimony,
the patients' testimony and/or statements, and the experts' testimony,
the preponderance of the evidence supports a conclusion that Respondent
prescribed controlled substances for a legitimate medical purpose.
However, the Deputy Administrator finds that Respondent did
prescribe anabolic steroids for muscle enhancement when it was illegal
to do so. As Judge Randall stated, ``[t]he Government is legitimately
concerned about the Respondent's failure to remain current with the law
concerning anabolic steroid prescribing. It is the registrant's
responsibility to know the state of the law affecting his profession,
and `I didn't know' does not justify the Respondent's unlawful
prescribing of anabolic steroids in 1992.''
In addition at the time of the investigation in this matter,
Respondent failed to keep complete and accurate records of his
controlled substance handling as required by 21 U.S.C. 287 CFR 1304.04
and 1304.21. However, according to Respondent he has properly
maintained the required records since 1995.
As other conduct which may threaten the public health and safety
under factor five, the Government asserted that Respondent failed to
acknowledge warnings of local pharmacists; failed to obtain information
from other physicians treating a patient at the same time as
Respondent; failed to alter his prescribing in response to a hospice
nurse's concerns; failed to deny controlled substance prescriptions to
an individual after he completed drug treatment; and improperly
continued to prescribe acetaminophen to a patient after she was
diagnosed with hepatitis.
The Deputy Administrator concurs with Judge Randall's conclusion
that Respondent's treatment of the patient with hepatitis did place the
patient's health at risk. However, the Deputy Administrator also agrees
with Judge Randall that the Government's other concerns did not place
his patients or the public health and safety at risk. He considered the
concerns of the other health care professionals and the fact that a
patient had just completed drug treatment in determining the
appropriate treatment for a patient. While it may have been prudent for
Respondent to contact other physicians who treated his patients, this
is not required and no evidence was presented to indicate that the
health and safety of his patients or the general public was endangered
by his failure to do so.
After reviewing the record in this matter, Judge Randall noted,
``[w]ithout a doubt, the Government had legitimate concerns as a result
of its initial investigation of the Respondent and his prescribing
practices.'' The Deputy Administrator finds it noteworthy that even one
of Respondent's experts testified that Respondent's documentation was
lacking and that lack of sufficient documentation places a physician at
risk. However, despite the large number of prescriptions issued by
Respondent, the pharmacists' concerns, and the evaluation of the
Government's expert, the Government has failed to prove by a
preponderance of the evidence that Respondent's continued registration
would be inconsistent with the public interest. As a result, Judge
Randall recommended that no action be taken against Respondent's
registration.
In evaluating this case, it is apparent that there is disagreement
within the medical community regarding the use of controlled substances
in the treatment of chronic pain. As Judge Randall noted, ``DEA is in a
difficult position, for it is asked to determine appropriate
prescribing practices in a treatment area in which the medical
profession is not in accord: the treatment of chronic pain patients.''
However, DEA has previously held that it is not DEA's role to resolve
this disagreement. In William F. Skinner, M.D., 60 FR 62,887 (1995),
the then-Deputy Administrator found that, ``the conflicting expert
opinion evidence presented leads to the conclusion that the medical
community has not reached a consensus as to the appropriate level of
prescribing of controlled substances in the treatment of chronic pain
patients. * * * It remains the role of the treating physician to make
medical treatment decisions consistent with a medical standard of care
and the dictates of the Federal and State law.''
Here, the Government's evidence is outweighed by the testimony of
Respondent and his experts, the patients' testimony and statements, and
the patient charts.
While it is true that Respondent prescribed anabolic steroids for
muscle enhancement and did not maintain proper records of his
controlled substance handling, revocation of his registration is not
warranted. Respondent admitted that his prescribing of anabolic
steroids was illegal. However, he ceased such prescribing immediately
upon learning that it was illegal and has not prescribed anabolic
steroids for muscle enhancement since. Judge Randall stated,
``[a]lthough this corrective action does not justify the Respondent's
failure to remain current in the law, * * * his actions show his desire
and willingness to comply with the law in the prescribing of controlled
substances.''
Respondent also clearly did not maintain adequate controlled
substances records, but he accepted responsibility for his inadequate
recordkeeping and now maintains complete and accurate records. Here
Judge Randall stated, ``[a]gain, the Respondent's remedial efforts do
not justify his prior failure to comply with record-keeping
requirements, but such efforts do demonstrate that the DEA has
certainly acquired this Respondent's attention. His response has been
to take affirmative action to correct his prior mistakes.''
The Deputy Administrator finds it significant that Respondent has
taken several courses since the investigation of his practice
concerning pain management and handling controlled substances. As Judge
Randall noted, ``although such remedial actions do not justify the
Respondent's prior lack of knowledge, it does demonstrate his sincerity
in updating his credentials, consistent with his current medical
practice.''
The Deputy Administrator agrees with Judge Randall that based upon
the record as a whole, no adverse action is warranted against
Respondent's DEA Certificate of Registration. However, the Deputy
Administrator notes that the
[[Page 25080]]
treatment of chronic pain patients is a difficult business. Since pain
is mainly subjective, physicians must rely heavily on the complaints of
patients. Because of this, physicians must be ever vigilant for
evidence of diversion of controlled substances for other than
legitimate medical purposes.
Accordingly, the Deputy Administrator of the Drug Enforcement
Administration, pursuant to the authority vested in him by 21 U.S.C.
823 and 824 and 28 C.F.R. 0.100(b) and 0.104, hereby orders that DEA
Certificate of Registration AS9420059, previously issued to Paul W.
Saxton, D.O., be, and it hereby is, continued with no adverse action
being taken.
Dated: May 3, 1999.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 99-11580 Filed 5-7-99; 8:45 am]
BILLING CODE 4410-09-M