Federal Register / Vol. 65, No. 24 / Friday, February 4, 2000 / Notices 5665

1The Government did not provide any evidence

of the statutory provisions relating to weight control

in existence prior to 1987.

that he can responsibly handle

controlled substances.

Therefore, the Deputy Administrator

concludes that Respondent should be

issued a DEA Certificate of Registration

in Schedules IV and V subject to the

following restrictions for three years

from the date of issuance of the DEA

Certificate of Registration:

(1) While Respondent will be

registered in Schedule IV, he shall not

prescribe, dispense, administer, order or

otherwise handle Xanax, Stadol, or their

generic equivalents.

(2) Respondent shall send copies of

records documenting all of his

purchases of controlled substances to

the Special Agent in Charge of the DEA

Atlanta office, or his designee, on a

quarterly basis.

(3) Respondent shall submit, on a

quarterly basis, a log of all of the

controlled substances he has prescribed,

administered, or dispensed during the

previous quarter, to the Special Agent in

charge of the DEA Atlanta office, or his

designee. The log shall include: the

patient’s name; the date that the

controlled substance was prescribed,

administered or dispensed; and the

name, dosage and quantity of the

controlled substance prescribed,

administered or dispensed. If no

controlled substances are prescribed,

administered or dispensed during a

given quarter, Respondent shall indicate

that fact in writing in lieu of submission

of the log.

(4) Respondent shall consent to

random, unannounced inspections by

DEA 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 the application for

registration submitted Robert M.

Golden, M.D., be, and it hereby is,

granted in Schedules IV and V, subject

to the above described restrictions. This

order is effective upon the issuance of

the DEA Certificate of Registration, but

no later than March 6, 2000.

Dated: January 18, 2000.

Donnie R. Marshall,

Deputy Administrator.

[FR Doc. 00–2539 Filed 2–3–00; 8:45 am]

BILLING CODE 4410–09–M

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).

5666 Federal Register / Vol. 65, No. 24 / Friday, February 4, 2000 / Notices

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).

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

Federal Register / Vol. 65, No. 24 / Friday, February 4, 2000 / Notices 5667

2National Task Force on the Prevention and

Treatment of Obesity, Long-term Pharmacotherapy

in the Management of Obesity, 276 JAMA 1907

(1996).

or she has a BMI of 27 [kilograms/meters

squared] or more, that a person age thirtyfour 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-forweight 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.

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.

5668 Federal Register / Vol. 65, No. 24 / Friday, February 4, 2000 / Notices

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

Federal Register / Vol. 65, No. 24 / Friday, February 4, 2000 / Notices 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

5670 Federal Register / Vol. 65, No. 24 / Friday, February 4, 2000 / Notices

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

Federal Register / Vol. 65, No. 24 / Friday, February 4, 2000 / Notices 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

5672 Federal Register / Vol. 65, No. 24 / Friday, February 4, 2000 / Notices

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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 98–16]

Judy L. Henderson, D.V.M.; Grant of

Restricted Registration

On February 3, 1998, the Deputy

Assistant Administrator, Office of

Diversion Control, Drug Enforcement

Administration (DEA), issued an Order

to Show Cause to Judy L. Henderson,

D.V.M. (Respondent) of Corinth,

Mississippi, notifying her of an

opportunity to show cause as to why

DEA should not deny her application

for registration as a practitioner

pursuant to 21 U.S.C. 823(f), for reason

that her registration would be

inconsistent with the public interest.

By letter dated March 3, 1998,

Respondent requested a hearing on the

issues raised by the Order to Show

Cause. Following prehearing

procedures, a hearing was held in

Memphis, Tennessee on November 18,

1998, and April 20, 1999, before

Administrative Law Judge Mary Ellen

Bittner. At the hearing, the Government

called witnesses and introduced

documentary evidence and Respondent

testified on her own behalf. After the

hearing both parties submitted proposed

findings of fact, conclusions of law and

argument.

On September 21, 1999, Judge Bittner

issued her Opinion and Recommended

Ruling, Findings of Fact, Conclusions of

Law and Decision (Opinion),

recommending that Respondent’s

application for registration be granted

limited to four specific substances and

subject to two conditions. Neither party

filed exceptions to Judge Bittner’s

Opinion, and on October 25, 1999,

Judge Bittner transmitted the record of

these proceedings to the Deputy

Administrator.

The Deputy Administrator has

considered the record in its entirety,

and pursuant to 21 CFR 1316.67, hereby

issues his final order based upon

findings of fact and conclusions of law

as hereinafter set forth. The Deputy

Administrator adopts the findings of

fact and conclusions of law of the

Administrative Law Judge in their

entirety, and adopts with several

modifications, as noted below, the

conclusion and recommended decision

of the Administrative Law Judge. His

adoption is in no manner diminished by

any recitation of facts, issues or

conclusions herein, or of any failure to

mention a matter of fact or law.

The Deputy Administrator finds that

Respondent is a veterinarian. At various

times during her career she suffered

from serious medical conditions which

prevented her from practicing veterinary

medicine.

In March 1987, a local pharmacist

advised the Mississippi Bureau of

Narcotics (MBN) that Respondent had

used prescriptions and DEA order forms

to obtain a large amount of Demerol, a

Schedule II narcotic controlled

substance, from the pharmacy. A

subsequent pharmacy survey revealed a

total of six prescriptions and eight order

forms written by Respondent. The

prescriptions were for a total of 30

dosage units of Ionamin, a Schedule IV

controlled substance, 30 dosage units of

diazepam, a Schedule IV controlled

substance, six ampules of Demerol, one

ounce of liquid Demerol, and 20 dosage

units of Mepergan Fortis, a Schedule II

narcotic controlled substance. The

Ionamin and diazepam prescriptions

listed Respondent as the patient, the

prescription for six ampules of Demerol

listed the clinic where Respondent

worked and had the notation ‘‘clinic use

only,’’ the Mepergan Fortis prescription

was made out to Respondent’s thenhusband, and the prescription for one

ounce of Demerol was made out in a

dog’s name. Each of the order forms was

for one 30 cc. vial of Demerol.

On March 26, 1987, MBN agents

interviewed Respondent who told the

agents that she had obtained the various

narcotics for her own use because she

suffered from extremely painful medical

conditions. The agents subsequently

confirmed with Respondent’s physician

that he was treating Respondent for the

medical conditions. However, the

physician indicated that he did not

know that Respondent was selfprescribing and that he would help her.

No charges were filed against

Respondent as a result of this

investigation.

Respondent testified at the hearing in

this matter that she was treated with

intravenous Demerol for a painful

kidney disorder. Following surgery for

this disorder, Respondent experienced

withdrawal from the Demerol.

Respondent testified that she was

ashamed that she had become

dependent on the Demerol and

attempted to wean herself off by taking

oral Demerol intended for the animals

she treated. This attempt was

unsuccessful and in fact Respondent

was taking more Demerol than she had

before her surgery. According to

Respondent she then began injecting

herself with Demerol. Finally, at or

about the end of November 1997,

Respondent entered a 28-day treatment

program and stopped using controlled

substances.