[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