[Federal Register Volume 64, Number 248 (Tuesday, December 28, 1999)]
[Notices]
[Pages 72678-72685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33644]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 96-10]
Wesley G. Harline, M.D.; Continuation of Registration With
Restrictions
On October 27, 1995, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA) issued an
Order to Show Cause to Wesley Harline, M.D. (Respondent) of Ogden,
Utah, notifying him of an opportunity to show cause as to why DEA
should not revoke his DEA Certificate of Registration AH1650248 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.
By letter dated December 14, 1995, Respondent, through counsel,
filed a request for a hearing, and following prehearing procedures, a
hearing was held in Salt Lake City, Utah on April 1 through 3 and May 6
through 8, 1997, and by telephone in Salt Lake City and Arlington,
Virginia, on August 18 through 21, 1997, before Administrative Law
Judge Mary Ellen Bittner. At the hearing both parties called witnesses
to testify and introduced documentary evidence. After the hearing both
parties submitted proposed findings of fact, conclusions of law and
argument.
In this brief, Respondent's counsel included findings based upon
evidence that was not introduced at the hearing. On January 5, 1998,
the Government filed a Motion to Strike Post Record Evidence from
Respondent's Proposed Findings of Fact, Conclusions of Law and
Argument. On January 21, 1998, Respondent filed his Opposition to
Government's Motion to Strike Post Record Evidence, and in the
alternative, Motion to Reopen the Record.
On April 2, 1999, Judge Bittner issued her Opinion and Recommended
Ruling Findings of Fact, Conclusions of Law and Decision (Opinion),
granting the Government's motion to strike the additional evidence,
denying Respondent's motion to reopen the record, and recommending that
Respondent's DEA Certificate of Registration be revoked and any pending
applications be denied. On June 14, 1999, Respondent filed exceptions
to Judge Bittner's Opinion and on August 2, 1999, the Government filed
its response to Respondent's exceptions. Thereafter, on August 10,
1999, Judge Bittner transmitted the record of these proceedings to the
Deputy Administrator.
While this matter was pending with the Deputy Administrator,
Respondent submitted a letter dated November 4, 1999, responding to the
Government's response to his exceptions and formally moving that the
record be reopened to allow additional evidence to be considered. As
will be discussed more fully below, the Acting Deputy Administrator
denies Respondent's motion to reopen the record and has not considered
Respondent's letter dated November 4, 1999, in rendering his decision
in this matter.
The Acting 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 Acting Deputy Administrator adopts, except as
[[Page 72679]]
specifically noted below, the findings of fact set forth in Judge
Bittner's Opinion, but does not adopt Judge Bittner's recommended
conclusions of law and decision.
The Acting Deputy Administrator finds that Respondents graduated
from medical school in 1945. In or about 1953, Respondent joined a
general surgery practice in Ogden, Utah. He has been a licensed
physician in Utah since 1953 and has held state and Federal
authorizations to handle controlled substances since approximately the
time he obtained his medical license. According to Respondent, sometime
in the 1980s, he virtually terminated his general surgery practice to
concentrate on cosmetic surgery. Respondent testified that he
considered weight control to be a part of cosmetic surgery, and as of
1997, he saw 15 to 20 weight control patients every weekday and a few
weight control patients on Saturdays.
Primarily at issue in this proceeding is whether Respondent
properly prescribed controlled substances to his weight control
patients. Therefore, provisions of Utah law relating to this issue were
placed into evidence. As of 1987 1, the Utah Administrative
Code (Administrative Code) authorized the Utah Division of Occupational
and Professional Licensing (DOPL) to revoke a State license to handle
controlled substances if the holder ``[p]rescribes or administers any
controlled substance for weight control for more than 30 days in any 12
twelve-month period.'' Utah Admin. Code R153-37-8 (1987-1988). The
Administrative Code also required that ``each prescription for a
controlled substance and the number of refills authorized shall be
documented in the patient records by the prescribing practitioner.''
Utah Admin. Code R153-37-10.D (1987-1988).
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\1\ The Government did not provide any evidence of the statutory
provisions relating to weight control in existence prior to 1987.
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The 1989 Administrative Code generally provided that:
Prescribing practitioners shall keep accurate records reflecting
the examination, evaluation and treatment of all patients. Patient
medical records shall accurately reflect the prescription or
administration of controlled substances in the treatment of the
patient, the purpose for which the controlled substances is utilized
and information upon which the diagnosis is based.
Utah Admin. Code R153-37-.A (1989). Further, Utah Admin. Code R153-37-
10.H (1989), provided that Schedule II controlled substances could not
be prescribed, dispensed or administered for weight reduction or
control. In addition, section 10.J essentially provided that Schedule
III and IV controlled substances could only be used for weight
reduction in the treatment of obesity as an adjunct, in accordance with
Food and Drug Administration approved labeling for the product, and in
a regimen of caloric restriction provided that among other things the
prescribing practitioner determines that the patient has made good
faith efforts to lose weight in a structured treatment program and the
program was ineffective; obtains a thorough history; performs a
thorough physical examination; and rules out any contraindications to
the use of controlled substances. This section precluded the
prescribing of Schedule III and IV controlled substances for weight
reduction for a period longer than 12 weeks in any one year period.
Also pursuant to this section, a practitioner was required to
discontinue prescribing controlled substances if the patient failed to
lose weight while under treatment for a period of 28 days as determined
by weighing of the patient at least every fourteenth day.
In 1991, the provision was reworded slightly but essentially was
substantively unchanged, and remained so until January 29, 1996. As of
that date, Utah Admin. Code R156-37-604 (1996) provided that Schedule
II and III controlled substances shall not be prescribed, dispensed, or
administered for purposes of weight reduction or control. Further,
Schedule IV controlled substances can only be used in the treatment of
excessive weight when certain conditions are met. However, this
provision no longer imposed the 12 week limitation on the use of
Schedule IV controlled substances.
On June 5, 1992, the DOPL issued an emergency under restricting
Respondent's authority to perform certain types of surgery and ordering
him to cease providing overnight patient care at his facility. On
September 29, 1993, a Third Amended Petition was filed in that
proceeding alleging, among other things, that Respondent prescribed a
Schedule III anorectic controlled substance beyond the period of time
permitted by Utah regulation to at least 13 patients and that the
prescriptions did not bear the full names and addresses of the patients
and the dates issued as required by law.
On December 10, 1996, Respondent executed a Stipulation and Order
in which he denied all of the allegations of the Third Amended Petition
but agreed to various terms and conditions. Specifically, the
Stipulation and Order suspended Respondent's medical license for three
months, but stayed enforcement of the suspension and placed his license
on a five-year probation subject to various conditions including that
he provide adequate means to permit patients to exercise informed
consent with respect to medical and surgical procedures, anesthesia,
and medications to be administered or dispensed; meet with the
Physicians' Licensing Board (Board) quarterly for five years; allow a
qualified physician to review records of 1.4 percent of his patients;
and maintain prescription records in accordance with State and Federal
law and make his prescription records available for inspection by the
board and the DOPL upon request.
In the latter half of 1995, DEA conducted a pharmacy survey to
determine whether Respondent was complying the various regulatory
requirements. The survey revealed that Respondent had written
prescriptions for anorectic controlled substances for more than 12
weeks in a year in violation of state law. The survey further revealed
seven prescriptions that Respondent issued between 1993 and 1995 and
202 prescriptions that he issued between 1990 and 1992 that did not
bear the patient's full name and/or date of issuance.
Respondent testified that he had written incomplete prescriptions,
but that in discussions with other physicians he had learned that such
prescriptions ``are a quite frequent occurrence.'' According to
Respondent, he was told by a DOPL investigator that no more than 50% of
prescriptions for Schedule II, IV and V controlled substances are
properly filled out.
On May 11, 1995, DOPL subpoenaed records for 43 of Respondents's
patients. At issue in this proceeding is whether Respondent properly
prescribed controlled substances to these patients for weight control.
As a result, there was evidence presented by both the Government and
Respondent regarding when an individual is considered obese or
overweight, when the use of controlled substances is appropriate for
weight control, and when such treatment is deemed effective. The
Government offered the testimony of a physician who mainly treats
chronic pain patients, but who was qualified as an expert in the
legitimate use of anorectic controlled substances. Respondent testified
on his own behalf and also offered the testimony of a physician whose
practice prior to 1991 consisted of some weight management patients and
since 1991 was solely weight management patients. Both parties offered
extensive documentary evidence.
[[Page 72680]]
Evidence was presented that different methods are used to determine
when a patient is considered obese or overweight. These include
comparing the patient's height and weight to charts published by
insurance companies, and calculating the individual's body mass index
(BMI), which is the person's weight in kilograms divided by the square
of his/her height in meters. The Government's expert as well as most of
the documentary evidence regarding this issue cite BMI as the best
general guideline. Judge Bittner went into great detail, which will not
be repeated here, summarizing the various opinions in evidence
regarding at what BMI an individual is considered obese or overweight.
After reviewing all of the evidence, the Acting Deputy Administrator
finds that there seems to be disagreement within the medical community
as to when an individual is considered obese or overweight using BMI as
a guideline.
Respondent testified that his standard practice for weight control
patients during the time period at issue was to use the life insurance
tables, and that he was not aware of BMI as a criterion until the
1990s. He further testified that although BMI is ``helpful'' in
determining whether or not to prescribe weight control medication, he
found it cumbersome to use.
Judge Bittner concluded that:
Based on my review of all the foregoing, and recognizing that
there is some disagreement among the experts, I find that for
purposes of this proceeding the [National Institute of Health's
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK)] definitions are the most appropriate standards. I therefore
find that a person aged thirty-five or older is obese if he or she
has a BMI of 27 [kilograms/meters squared] or more, that person age
thirty-four or younger should be considered obese if he or she has a
BMI of 25 [kilograms/meters squared] or more, and that a BMI greater
than 30 [kilograms/meters squared] indicates moderate to severe
obesity.
The Acting Deputy Administrator disagrees with Judge Bittner that
the NIDDK definitions are the most appropriate standards. The Acting
Deputy Administrator finds that given the disagreement within the
medical community, he is not comfortable finding that one standard is
more appropriate than another. In fact the NIDDK standard that Judge
Bittner cites also noted that while BMI ``is the measurement of choice
for many physicians and researchers studying obesity,'' it
poses some of the same problems as the height-for-weight tables.
Doctors don't agree on the cutoff points for ``healthy'' versus
``unhealthy'' BMI ranges. BMI does not provide information on a
person's percentage of body fat. However, like the height-for weight
table, BMI is a useful general guideline.
Understanding Adult Obesity, NIH Publication No. 94-3680, November 1993
http://www.niddk.nih.gov/Aobesity/adultobe.htm>.
Therefore, the Acting Deputy Administrator is reluctant to set an
objective standard to determine when an individual is considered obese
or overweight which might not necessarily be appropriate for each
patient. Rather it appears that there are a number of different
criteria that may be considered by a physician in determining whether
an individual patient is obese or overweight.
Next, Judge Bittner addressed when it is appropriate to use
controlled substances in a weight loss program. A consensus of the
documentary evidence, as well as the testimony of both Respondent and
the Government's expert, indicate that obesity is a chronic condition,
and as such, using medication to treat it only for a short time is not
effective. However, by virtue of the fact that the drugs at issue are
controlled substances, it has already been determined that these drugs
have some potential for abuse and that abuse would lead to some level
of physical or psychological dependence.
The Physicians' Desk Reference (PDR) advises that these drugs
should only be used for a few weeks. However, DEA has previously held
that the PDR is not binding on a physician. See Paul W. Saxton, D.O.,
64 FR 25, 073 (1999); Margaret E. Sarver, M.D., 61 FR 57, 896 (1996).
Even the Government's expert testified that research has found that the
Food and Drug Administration recommendations on which the PDR is based
may be too restrictive, at least for some Schedule IV substances. The
Government's expert further testified that the risks associated with
the controlled substances at issue here are low and that the
medications are reasonably safe drugs, but that they do have side
effects and there is some potential for abuse, although low for
Schedule IV substances. The Government's expert testified that the
potential benefit of using controlled substances must be balanced
against the potential risk.
Judge Bittner went into great detail, which will not be reiterated
here, regarding the documentary evidence regarding tolerance and the
abuse potential associated with anorectic controlled substances and as
to their efficacy. After reviewing all of this evidence, the Acting
Deputy Administrator concludes that there have been few if any
meaningful studies on the long-term use of anorectic controlled
substances in the treatment of weight control.
However, the Acting Deputy Administrator finds it noteworthy that
in the prologue to the Anorectic Usage Guidelines adopted by the
American Society of Bariatric Physicians on November 10, 1990 (1990
ASBP Prologue) it was reported that the reported incidence of serious
side effects of Schedule III and IV anorectics ``is low indeed.'' The
1990 ASBP Prologue also stated, among other things, that short and long
term studies have not documented concerns about the abuse potential of
anorectics, and that a significant number of bariatric physicians
reported that they maintained patients on anorectics for long periods
of time without significant ill effects. The 1990 ASBP Guidelines
stated that Schedule III and IV anorectics ``can often be useful in
helping patients to lose weight and to maintain a reduced weight,'' and
that these medications ``by definition have a low level of risk and
little potential for addiction or psychologic dependence when carefully
used by a physician in a properly supervised medical practice.''
The Acting Deputy Administrator also finds it significant that in a
1996 article,2 the National Task Force on the Prevention and
Treatment of Obesity (National Task Force) advised that obesity is
likely to require continued treatment, and that therefore drug
treatments for only weeks or months is generally not warranted. The
National Task Force warned that drug treatment might need to continue
for years, even for the patient's lifetime, but that there were few
published studies in which patients received these drugs for more than
a year. Consequently, the Acting Deputy Administrator is reluctant to
find that long-term use of anorectic controlled substances is
inappropriate.
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\2\ National Task Force on the Prevention and Treatment of
Obesity, Long-term Pharmacotherapy in the Management of Obesity, 276
JAMA 1907 (1996).
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Judge Bittner next addressed the criteria for an appropriate weight
loss program utilizing controlled substances. The Government's expert
and the documentary evidence suggest that controlled substances should
only be used as part of an overall program including dietary
modification, behavioral instruction and exercise. The Government's
expert emphasized that the key determinant of a weight loss program's
efficacy is whether the weight
[[Page 72681]]
loss improves the patient's health. It was the opinion of the
Government's expert that it is not appropriate to use controlled
substances for weight loss in order to enhance a patient's self-image
or for prophylactic use, for instance if other members of a patient's
family are overweight. According to the Government's expert it is not
appropriate to prescribe controlled substances for cosmetic purposes.
Respondent testified that in determining whether to prescribe
medications for weight control he considered the patient's feelings
about him or herself, whether he or she wanted to lose weight, how much
the patient wanted to lose, and whether it was feasible for the patient
to do so.
The Government's expert testified that a weight loss of at least
10% is considered a good sustained weight loss. Other evidence in the
record indicates that some believe that a weight loss as low as 5% is
considered good. The Government's expert testified that once a 10%
weight loss has been achieved, that does not necessarily mean that
controlled substances should be discontinued because the medication
helps prevent regaining weight loss. But the expert further testified
that there needs to be an ongoing review process to assess the efficacy
of the use of controlled substances.
Judge Bittner went into great detail summarizing the documentary
evidence relating to the criteria for determining when controlled
substances should be utilized in a weight control program. After
considering all of the evidence the Acting Deputy Administrator
concludes that there appears to be a difference of opinion within the
medical community as to when it is appropriate to use controlled
substances in a weight management program and when such use is
considered effective.
The Acting Deputy Administrator finds it significant that the 1990
ASBP Guidelines specify that the guidelines,
provide suggestions regarding the use of the anorectics but they
are not intended to and indeed cannot, replace the individual
judgment of the treating bariatrician which remains and must remain
paramount. Thus, the bariatrician must not rely on these guidelines,
or on any other guidelines to provide an infallible blueprint for
patient treatment. It is not the intent of these guidelines to limit
the bariatricians' right to adjust the therapy based on the
patient's condition, medical problems or therapeutic response.
The Government's expert testified that this statement should be
interpreted in the context of a clear-cut treatment program with
established goals.
Judge Bittner concluded that
[i]n light of my findings above as to when a person should be
considered obese, I further find that anorectic controlled
substances should not be used in the treatment of a patient unless
the individual is thirty-five or more years of age and has a BMI of
at least 27 [kilograms/meters squared], or, if younger than thirty-
five years of age, has a BMI of 25 [kilograms/meters squared] or
more. I especially note that the evidence establishes that
prescribing controlled substances to a patient for cosmetic purposes
is not within the scope of legitimate medical practice.
* * * Based on my review of the record and for purposes of this
proceeding, I find that it is appropriate to continue prescribing
anorectic controlled substances to those patients who initially are
candidates for such treatment only if (a) the patient achieves a
loss of five percent of body weight or a reduction in BMI by one or
more units and maintains that loss for at least one year, or (b) if
the patient achieves a significant clinical response as defined in
the 1990 ASBP Guidelines, i.e., (1) a loss of at least twelve pounds
over the initial twelve weeks, and (2) a loss of at least four
pounds for each additional four weeks of treatment, providing that
if the patient has lost at least ten percent of his or her initial
body weight, he or she may be considered to have reached [90% Target
Weight] and may appropriately continue to be prescribed anorectics
if needed. If the patient gains weight and exceeds that benchmark,
the physician should cease prescribing the medications unless the
patient again achieves the [90% Target Weight] benchmark in a period
of time equaling one week for each pound above the benchmark.
(Footnotes omitted).
The Acting Deputy Administrator disagrees with these findings.
There appears to be differing opinions within the medical community as
to when it is appropriate to use controlled substances in weight
management treatment and when such use is considered effective. As a
result, the Acting Deputy Administrator is not comfortable setting
objective standards which might not necessarily be appropriate for each
individual patient.
As to the 42 patients at issue in this proceeding, Judge Bittner
went into great detail in her Opinion regarding their history of
treatment with Respondent. She discussed the patient charts and patient
summaries in evidence, the assessment of the Government's expert of
each patient, Respondent's testimony regarding each patient, and the
patient interviews conducted by DEA and/or the patients' testimony.
Since the Acting Deputy Administrator is adopting Judge Bittner's
findings of fact except as specifically noted, there is no need for him
to reiterate them. It should be noted that based upon the Acting Deputy
Administrator's rejection of certain of Judge Bittner's findings as
noted above, the Acting Deputy Administrator does not adopt any of
Judge Bittner's findings regarding specific patients that use her
objective standard to conclude the treatment with controlled substances
was inappropriate or to assess whether or not treatment was successful.
The Acting Deputy Administrator makes the following general
findings regarding Respondent's treatment of the patients at issue.
These patients were all being treated by Respondent for weight loss or
management. There is no evidence that anorectic controlled substances
were prescribed for other purposes, or that controlled substances
received pursuant to Respondent's prescriptions were sold or in any
other way diverted from the patients' use.
On the initial visit, the patient would be weighed, his/her height
would be measured and blood pressure taken. A family/medical history
would be taken and Respondent would perform a physical examination.
Respondent would discuss goals and a target weight with the patient,
give the patient a generalized diet, generally discuss exercise,
lifestyle changes, and possible side effects of the controlled
substances, and ask whether the patient had previously attempted to
lose weight and by what methods.
Thereafter, Respondent would see the patient no more than once a
month. In fact, several patients testified that they had tried to
obtain their prescriptions earlier because they were going on vacation,
but their requests were refused. At each visit the patient would be
weighed and his/her blood pressure taken. The patient would always be
seen by Respondent before any controlled substances would be
prescribed. Respondent would admonish the patient if he/she were not
losing weight. If the patient was not losing weight, Respondent would
very rarely change the diet he had provided the patient because
according to Respondent, more likely than not the patient was not
following the diet. Respondent would remind the patient on follow-up
visits of the importance of following the diet.
Respondent testified that he used the insurance company height and
weight tables to determine whether to use controlled substances in the
treatment of a patient. However, he also testified that he is now
stricter in his approach to weight control treatment.
Respondent's office manager testified that although a patient's
blood pressure was taken at each visit, the result was not always noted
in the patient's chart unless it was abnormal. Respondent testified
that he might not always note the responses to the medical/family
history questions or the results of the
[[Page 72682]]
physical examination in the patient's chart if the responses and/or
findings were normal.
For the most part, the charts for the patients at issue here not do
indicate the patient's target weight, medical history, or results of
physical examinations, nor do the charts indicate whether the patient
previously saw another physician for weight control or was ever
enrolled in a formal weight control program. Also, for the most part,
there is no indication in the charts that Respondent gave the patient
diet or exercise information on an initial or subsequent visit, or that
Respondent subsequently discussed these subjects with the patient or
modified the recommended diet and exercise regimens. Also there were
several instances where controlled substances were prescribed by
Respondent but not noted in the patient charts. In addition, a number
of the patients were prescribed benzodiazepines for extended periods of
time with no reason for these prescriptions noted in the charts.
The Government's expert testified that Respondent's patient records
did not comply with Utah requirements regarding patient histories and
physical examinations, and characterized Respondent's records as
``grossly deficient * * * in terms of the evaluation of the patients.''
According to the Government's expert, as far as the patient records
show, ``the patients came in, were weighed, were given a prescription
and left * * * That's all you can tell from the records. This isn't
saying other things weren't done, but certainly they weren't documented
if they were.''
Respondent testified that the medical records in evidence as
Government exhibits were incomplete, and included only his handwritten
notes, not all of the information in the patient charts, and that these
notes were the only portions of the charts that DEA investigators asked
his staff to copy. However as Judge Bittner pointed out, Respondent did
not object when the Government offered the charts into evidence, did
not request that the Government be required to introduce other
documents at that time, and did not offer the complete charts as his
own exhibits. Regarding the benzodiazepine prescriptions, while the
reasons for the prescriptions were not noted in the charts, Respondent
and the patients who testified were able to give explanations for the
prescriptions. Nonetheless, Respondent admitted at the hearing that his
patient records were not as good as they could have been.
Respondent also admitted that with respect to all 42 patients at
issue in this proceeding, he violated Utah law in existence at the time
that limited the prescribing of Schedule III and IV anorectic
controlled substances to no more than 12 weeks in a one-year period
(12-week rule). Respondent testified that he did not agree with Utah's
pre-1996 restriction because a weight control program for 12 weeks is
not feasible and that the rule was not in the mainstream of medicine.
According to Respondent, ``I thought I was still in the mainstream of
medicine, because most of my colleagues were violating the 12-week rule
and certainly all of the drugstores were.'' Respondent asserted that
``that doesn't make me any less guilty, but it explains why I did it.''
Respondent testified that he should not have disobeyed the law but he
felt that it was in the best interest of his patients. He further
testified that his patients have been inconvenienced and embarrassed by
their involvement in these proceedings, and that his health has
suffered and he has been financially burdened due to his violation of
the law.
In general, the Government's expert opined that it did not appear
that Respondent monitored the patients' treatment; that the patient
interviews failed to show the Respondent used any behavior therapy;
that many of Respondent's patients did not qualify as candidates for
treatment with anorectic controlled substances ``under any
definition,'' and that it did not appear that Respondent placed his
patients on structured diet and exercise programs. The Government's
expert testified that the lack of documentation in the patient charts
raised questions about the quality of care that Respondent provided
these patients.
For the most part, the Government's expert concluded that
Respondent's treatment of the patients at issue with controlled
substances was not appropriate. Respondent admitted that his treatment
of 10 of the patients was a failure. However, even the Government's
expert conceded that Respondent's treatment of several of the patients
was successful and he characterized Respondent's treatment of several
others as minimally effective.
Respondent's treatment of one patient is of particular concern.
From January 1993 to May 1995, the patient was prescribed Nardil, a
non-controlled antidepressant, as well as anorectic controlled
substances. The Government's expert characterized Nardil as a ``fairly
dangerous medication,'' that is typically prescribed by psychiatrists.
According to the Government's expert, even many psychiatrists are
reluctant to prescribe Nardil because it interacts with a number of
other drugs, particularly anorectics, and some foods which can lead to
life threatening side effects. At the hearing in this matter,
Respondent conceded that he made a mistake and should not have
prescribed Nardil for this patient.
At the hearing in this matter, Respondent testified that he did not
know when he became aware of the 12-week rule. He further testified
that he was not aware of the change in Utah law effective January 16,
1996, which prohibited the prescribing of Schedule III controlled
substances for weight control and which eliminated the 12-week rule for
Schedule IV controlled substances, until he was personally advised of
this change by a DOPL inspector in February 1996. A pharmacy survey
revealed that Respondent had issued 16 prescriptions for Schedule III
anorectics after the effective date of the law prohibiting such
prescribing but before he was advised of the change in the law by the
DOPL inspector.
There was also an allegation raised at the hearing that Respondent
authorized a pharmacy to change a prescription that he had written on
March 12, 1996 for a Schedule IV controlled substance to a Schedule III
controlled substance. A DOPL investigator testified that a pharmacy
technician indicated that the patient requested the change and the
pharmacy technician had gotten approval from someone at Respondent's
office. Respondent testified that the individual at his office did not
recall giving the pharmacy technician authorization to change the
prescription. Respondent further testified that ``I'm not stupid. I
have been notified months previous that this was no longer a drug that
we prescribed,'' and that he would not have authorized such a change.
Evidence was presented by Respondent regarding his practice as of
the date of the hearing. Respondent testified that his patient charts
have been ``up to speed'' from the time he entered into the agreement
with the state to undergo peer review. Also as of August 1997, he
follows procedures specified in a document that was prepared with the
assistance of counsel which includes a checklist for the physician on
the initial consult, a medical history form, an informed consent form,
and a follow-up consultation questionnaire. These forms all remain as
part of each patient's permanent record. Respondent's office manager
testified that weight control patients are now given a handbook
[[Page 72683]]
which includes information on diet, exercise, and medication.
Respondent testified that he is now complying with all State, Federal
and local laws pertaining to controlled substances and would never
violate a regulation in the future.
In this brief filed after the conclusion of the hearing,
Respondent's counsel sought to introduce and rely upon evidence not
admitted at the hearing. Respondent's counsel attached and discussed in
his brief a letter dated October 2, 1997, from a physician who stated
that he had conducted a random sampling of Respondent's charts for
weight control patients. In a motion filed on January 5, 1998, the
Government objected to consideration of this information arguing that
Respondent did not move to reopen the record to receive additional
evidence, and even if he had, the record should not be reopened because
Respondent has not demonstrated that the evidence was previously
unavailable and is material and relevant. See Robert M. Golden, M.D.,
61 FR 24,808 (1996). Further the Government asserted that at most, the
letter shows that Respondent is complying with his probationary
requirements with the Board, which is presumed, and that the letter
raises issues of fact that would require further testimony and
documentary evidence in this proceeding. On January 21, 1998,
Respondent filed his opposition to the Government's motion in which he
moved to reopen the record and argued that the letter meets the
standard for reopening the record.
In her opinion, Judge Bittner granted the Government's motion to
strike from Respondent's brief the October 2, 1997 letter and
references to it. Judge Bittner found that to appropriately evaluate
the assertions in the October 2, 1997 letter the record would have to
be reopened for additional testimony and documentary evidence. Judge
Bittner further found that this is not warranted since, ``the most the
letter adds to the record is an indication that Respondent is complying
with his probation; [and] as the Government asserts, such compliance is
presumed.''
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.
(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).
Regarding factor one, Judge Bittner noted that Respondent entered
into a Stipulation and Order with the DOPL in December 1996, but no
restrictions were imposed on his state authorization to handle
controlled substances. Judge Bittner concluded however, that ``inasmuch
as State licensure is a necessary but not sufficient condition for DEA
registration, this factor is not dispositive.'' In his exceptions to
Judge Bittner's opinion, Respondent contended that the state ``is in
the best position to judge Respondent's fitness to practice.''
Respondent argued that it is ``unfair and excessively punitive'' for
DEA to seek to take action against Respondent above and beyond that
taken by the state. The Acting Deputy Administrator notes that the
recommendation of the appropriate state licensing authority is but one
factor to be considered in determining the public interest. However in
this case, the Acting Deputy Administrator does find it significant
that Utah did not restrict Respondent's ability to handle controlled
substances after reviewing Respondent's treatment of his weight control
patients, his documentation in his patient charts, and his failure to
include all required information on controlled substance prescriptions.
As to factor two, Judge Bittner found that Respondent prescribed
the patients at issue anorectic controlled substances for anywhere from
a few months to twenty years, and that the vast majority were
prescribed Schedule III controlled substances. Judge Bittner noted that
``[a]lthough Respondent introduced evidence on the long-term use of
some Schedule IV medications, the record is devoid of such evidence
with respect to Schedule III anorectics.'' Judge Bittner evaluated the
treatment of these 42 patients and concluded that
Respondent's treatment of all forty-two patients whose records
are in evidence was inappropriate because he did not provide the
comprehensive program required by good medical practice. In
addition, twenty-six of the patients were not sufficiently
overweight to justify treatment with controlled substances at the
outset and eight of these became obese while taking the medications.
Of the sixteen patients who may initially have been candidates for
treatment with anorectic controlled substances, ten did not achieve
a weight loss that met the standard of efficacy stated above.
Judge Bittner also found it significant that Respondent prescribed
benzodiazepines to 14 patients for substantial periods of time without
documenting the reasons for the prescriptions in the patient charts. As
a result, Judge Bittner ``conclude[d] that this factor weighs strongly
in favor of a finding that Respondent's continued registration would
not be in the public interest.''
The Acting Deputy Administrator finds that it does seem like
Respondent issued a large number of prescriptions for anorectic
controlled substances to the majority of these patients. However, the
Acting Deputy Administrator cannot find that Respondent's prescribing
was inappropriate. While the record is devoid of much evidence
regarding the long-term use of Schedule III anorectics, the Acting
Deputy Administrator is reluctant to find that such prescribing is
inappropriate. In evaluating this case, it is apparent that there is a
variety of opinions within the medical community as to when a person is
considered obese or overweight and when it is appropriate to use
controlled substances in the treatment of weight control.
DEA has been faced with an analogous situation when it sought to
determine whether physician's prescribing for chronic pain patients was
appropriate. In one recent case, the then-Deputy Administrator quoted
the Administrative Law Judge who stated that ``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 * * *'' Paul W. Saxton, D.O., 64 FR 25, 073 (1999). 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
[[Page 72684]]
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.''
As previously noted, the Acting Deputy Administrator does not agree
with Judge Bittner's conclusion that a person is obese or overweight at
a set BMI. While it is true that there is evidence in the record that
BMI is a good, if not the best, measure of obesity, there are still
other guidelines that may be considered. In addition there is
conflicting evidence in the record as to when it is appropriate to use
controlled substances. Consequently, the Acting Deputy Administrator
finds that it is not DEA's role to resolve these differences and set
the standard for the medical community. This is not to say that
physicians have free reign to prescribe anorectic controlled substances
for non-legitimate reasons. But in this case, all of the patients at
issue were seeking to control their weight and there is no evidence in
the record that the controlled substances were diverted from this
purpose.
While one might argue that Respondent did not individualize the
treatment for these patients as the evidence suggests is appropriate,
Respondent did meet with the patients before prescribing controlled
substances and when necessary would discuss diet and exercise with the
patients. On some occasions, Respondent would cease treatment when the
patient failed to follow Respondent's weight control program. Judge
Bittner took issue with the amount of time Respondent spent with the
patients saying that it was not sufficient to provide individualized
therapy. However, the Acting Deputy Administrator is not in a position
to find whether the amount of time spent with the patients was
sufficient since no evidence was presented as to what is considered an
appropriate amount of time.
As for Respondent's prescribing of benzodiazepines for extended
periods of time to some of these patients, it is true that Respondent
may not have documented his reasons for these prescriptions in the
patient charts. However, at the hearing, Respondent and some of these
patients testified as to why these controlled substances were
prescribed. The Acting Deputy Administrator concludes that he cannot
find that these prescriptions were inappropriate based on the fact that
the reasons for the prescriptions were not noted in the patients
charts.
The Acting Deputy Administrator finds that Respondent's prescribing
of Nardil along with anorectic controlled substances to one patient was
inappropriate. However, this is the only example of Respondent
prescribing contraindicated drugs, and Respondent has admitted that he
was wrong in so doing.
Regarding factor three, there is no evidence that Respondent has
been convicted of any criminal charges under State or Federal laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
As to factor four, Respondent's compliance with applicable laws,
Respondent has admitted that he violated Utah law with respect to the
42 patients at issue in this proceeding by prescribing anorectic
controlled substances to them for more than 12 weeks in a one year
period and by failing to properly document his treatment of these
patients in their charts. The Acting Deputy Administrator does not find
that Respondent violated 21 CFR 1306.04, which states that controlled
substances may only be prescribed for a legitimate medical purpose. As
discussed above, given the difference of opinion in the medical
community, the Acting Deputy Administrator cannot find that Respondent
issued controlled substance prescriptions to the patients at issue for
no legitimate medical purpose.
As to factor five, Judge Bittner concluded that Respondent did not
provide adequate assurances that he would properly document the
treatment of his patients in their charts. However, the Acting Deputy
Administrator finds that pursuant to the Stipulation and Order with the
state, Respondent's patient charts are currently reviewed on a periodic
basis for completeness. As a result the Acting Deputy Administrator
finds that Respondent's documentation will be sufficiently monitored.
Judge Bittner also concluded that Respondent showed no remorse for his
violations of Utah law and continued to assert that despite the medical
evidence to the contrary, there was no need to individualize the diet
and exercise programs, and that behavioral counseling would be useless.
The Acting Deputy Administrator finds that Respondent did show some
remorse for his violation of state law and indicated that he
acknowledged that what he did was wrong and he would not violate the
law in the future. The Acting Deputy Administrator also finds that
while Respondent appears reluctant to individualize his weight loss
treatment programs as suggested by the medical literature, this does
not warrant revocation of his DEA registration.
Judge Bittner concluded ``that the record as a whole establishes
that Respondent is unwilling or unable to accept the responsibilities
inherent in holding a DEA registration.'' As a result, Judge Bittner
concluded that Respondent's continued registration would be
inconsistent with the public interest and recommended that Respondent's
DEA registration be revoked.
Respondent filed exceptions to Judge Bittner's Opinion and the
Government filed a response to Respondent's exceptions which have all
been considered by the Acting Deputy Administrator in rendering his
decision in this matter. Most of the arguments set forth in these
filings have already been addressed in this final order, or it is not
necessary to address them in light of the findings of the Acting Deputy
Administrator. However, Respondent does argue in his exceptions that
Judge Bittner erroneously excluded the October 2, 1997 report of the
physician who reviewed Respondent's charts pursuant to the terms of the
Stipulation and Order with the state. In its response to Respondent's
exceptions, the Government argues that Judge Bittner properly excluded
the report since it added nothing to the record in this matter and in
order to properly assess the value of the report, the reviewing
physician would need to testify and be subjected to cross-examination.
This issue will be discussed below.
On August 10, 1999, the record in this matter was transmitted to
the Deputy Administrator. On November 4, 1999, Respondent sent a letter
to the Deputy Administrator responding to the Government's response to
his exceptions and attaching seven reports from the physician who
reviewed Respondent's patient charts pursuant to the Stipulation and
Order that were generated between October 2, 1997 and September 2,
1999. Respondent recognized that such a filing is not provided for in
the regulations, but argued that consideration of it is necessary ``to
avoid a gross miscarriage of justice.'' In addition, Respondent filed a
formal motion to reopen the record.
The Acting Deputy Administrator finds that Judge Bittner should
have reopened the record to allow Respondent to introduce into evidence
the October 2, 1997 report from the reviewing physician and to provide
the Government with an opportunity to cross-examine the physician and/
or introduce rebuttal evidence. Clearly, this report was not available
to
[[Page 72685]]
Respondent until October 2, 1997, after the conclusion of the hearing
in this matter. In addition, the Acting Deputy Administrator finds that
this report is clearly material and relevant to the issue in this
proceeding. Both Government counsel and Judge Bittner state that the
report merely shows that Respondent is complying with the state's
Stipulation and Order, which is presumed. However, the Acting Deputy
Administrator finds that this report also shows the extent of
Respondent's compliance. The issue in this proceeding is whether
Respondent's continued registration is inconsistent with the public
interest. The state of Respondent's current practice is clearly
relevant and this information was not available until after the
conclusion of the hearing.
Nonetheless, the Acting Deputy Administrator has decided to deny
Respondent's matter to the Administrative Law Judge and has further
decided not to remand this matter to the Administrative Law Judge and
has further decided to deny Respondent's request to reopen the record
dated November 4, 1999, to introduce the October 2, 1997 report of the
reviewing physician as well as six subsequent reports. As the
Government has stated, in order to admit these reports for
reconsideration, the Government would need to be provided with an
opportunity to cross-examine the reviewing physician and to possibly
introduce rebuttal evidence, which would delay a final decision in this
matter. In light of the findings and conclusions set forth in the final
order, the Acting Deputy Administrator does not believe that Respondent
would want to delay issuance of this decision. Therefore, the seven
reports of the reviewing physician attached to Respondent's November 4,
1999 letter have not been considered by the Acting Deputy Administrator
in rendering his decision in this matter.
The Acting Deputy Administrator has not considered the other
statements made by Respondent in the November 4, 1999 letter. First,
such a filing is not permitted by the regulations, and second, they
merely reiterate arguments already made by Respondent in his brief and
exceptions.
After reviewing the entire record in this matter, the Acting Deputy
Administrator concludes that revocation of Respondent's DEA Certificate
of Registration is not warranted. The Acting Deputy Administrator does
not find that the patients at issue in this proceeding were prescribed
controlled substances for no legitimate medical purpose. While
Respondent may not have been as careful in prescribing controlled
substances and in documenting the reasons for his prescribing, the
Acting Deputy Administrator does not believe that revocation is
appropriate given the dispute within the medical community as to when
it is proper to use controlled substances in weight control.
However, Respondent clearly violated state law by ignoring the 12-
week rule and by failing to properly document the treatment of his
patients. The Acting Deputy Administrator does not condone Respondent's
defiance of state law, but the Acting Deputy Administrator finds it
noteworthy that the state is currently monitoring Respondent's
treatment of patients and documentation of this treatment; that the
state did not restrict Respondent's ability to handle controlled
substances based upon the same patient charts in evidence in this
proceeding; and that Respondent has taken remedial steps to ensure that
he practices in compliance with the law.
But given Respondent's admitted defiance of state law by ignoring
the 12-week limitation on prescribing controlled substances for weight
control that was in effect at the time of the events at issue, the
Acting Deputy Administrator finds that some controls are necessary to
ensure that Respondent properly handles controlled substances in the
future. Therefore, for two years from the effective date of this final
order Respondent shall: (1) Forward to the DEA Salt Lake City office
copies of the reports of the physician reviewing his charts pursuant to
the Consent Order with the State of Utah; and (2) consent to
unannounced inspections by DEA personnel without requiring an
administrative inspection warrant.
Accordingly, the Acting Deputy Administrator of the Drug
Enforcement Administration, pursuant to the authority vested in him by
21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that
DEA Certificate of Registration AH1650248, previously issued to Wesley
G. Harline, M.D., be and it hereby is continued, and subject to the
above described restrictions. This order is effective January 27, 2000.
Dated: December 9, 1999.
Julio F. Mercado,
Acting Deputy Administrator.
[FR Doc. 99-33644 Filed 12-27-99; 8:45 am]
BILLING CODE 4410-09-M
