[Federal Register Volume 65, Number 24 (Friday, February 4, 2000)]
[Notices]
[Pages 5665-5672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2536]


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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 his 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 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 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. 
This final order replaces and supersedes the final order issued on 
December 9, 1999, and published at 64 FR 72678 (December 28, 1999). The 
Deputy Administrator adopts, except as 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 Deputy Administrator finds that Respondent 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 R153-38-8 (1987-1988).

[[Page 5666]]

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 R153-37-9.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 weighings 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 16, 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 order 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 with 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 III, IV and V controlled substances are 
properly filled out.
    On May 11, 1995, DOPL subpoenaed records for 43 Respondent'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.
    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 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

[[Page 5667]]

or she has a BMI of 27 [kilograms/meters squared] or more, that a 
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 Deputy Administrator disagrees with Judge Bittner that the 
NIDDK definitions are the most appropriate standards. The 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 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 25073 (1999); Margaret E. Sarver, M.D., 61 FR 57896 (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 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 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 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 treatment 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 
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 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 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.

[[Page 5668]]

    The 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 year 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 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 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 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 Deputy 
Administrator's rejection of certain of Judge Bittner's findings as 
noted above, the Deputy Administrator does not adopt any of Judge 
Bittner's findings regarding specific patients that use her objective 
standard to conclude that treatment with controlled substances was 
inappropriate or to assess whether or not treatment was successful.
    The 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 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 do not 
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 regimes. 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

[[Page 5669]]

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 that 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 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 that 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 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 24808 (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

[[Page 5670]]

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 16422 
(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 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 Deputy Administrator does not 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 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 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 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 physicians' prescribing for chronic pain patients was 
appropriate. In one recent case, the 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 25073 (1999). DEA has 
previously held that it is not DEA's role to resolve this disagreement. 
In William F. Skinner, M.D., 60 FR 62887 (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.''
    As previously noted, the 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 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 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

[[Page 5671]]

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 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 patient charts.
    The 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 one year period 
and by failing to properly document his treatment of these patients in 
their charts. The 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 
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 chards. However, the 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 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 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 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 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 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 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 
Respondent until October 2, 1997, after the conclusion of the hearing 
in this matter. In addition, the 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 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 Deputy Administrator has 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 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 Deputy Administrator in rendering his decision in 
this matter.
    The 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 Deputy 
Administrator concludes that revocation of Respondent's DEA Certificate 
of

[[Page 5672]]

Registration is not warranted. The 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 
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 Deputy Administrator does not condone Respondent's 
defiance of state law, but the 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 
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 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, subject to the above 
described restrictions. This order is effective March 6, 2000, and is 
the final agency action for appellate purposes pursuant to 21 U.S.C. 
877.

    Dated: January 18, 2000.
Donnie R. Marshall,
Deputy Administrator.
[FR Doc. 00-2536 Filed 2-3-00; 8:45 am]
BILLING CODE 4410-09-M