[Federal Register Volume 59, Number 171 (Tuesday, September 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21829]
[[Page Unknown]]
[Federal Register: September 6, 1994]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 92-90]
John W. Copeland, M.D.; Revocation of Registration
On September 9, 1992, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to John W. Copeland, M.D. (Respondent), of Antioch,
California, proposing to revoke Respondent's DEA Certificate of
Registration, AC8638085, and to deny any pending applications for
registration as a practitioner under 21 U.S.C. 823(f) and 824(a). The
Order to Show Cause alleged that Respondent's continued registration is
inconsistent with the public interest, as that term is used in 21
U.S.C. 823(f) and 824(a)(4) and that Respondent was convicted of a
felony under State law relating to controlled substances, as set forth
in 21 U.S.C. 824(a)(2). Specifically, the Order to Show Cause alleged
that between December 1987 and October 1989, Respondent dispensed
Ritalin, a Schedule II controlled substance, to ten individuals for
other than legitimate medical purposes and outside the scope of his
professional practice; between January 1988 and October 1989,
Respondent dispensed anabolic steroids, Schedule III controlled
substances under applicable state law, to fifteen individuals for other
than legitimate medical purposes and outside the scope of his
professional practice; and on May 30, 1991, Respondent was convicted in
the State of California of six felony counts of prescribing controlled
substances to addicts or habitual users of controlled substances and
such prescriptions were not issued as part of an authorized methadone
program.
Respondent, through counsel, timely filed a request for a hearing
on the issues raised in the Order to Show Cause and the matter was
docketed before Administrative Law Judge Mary Ellen Bittner. Following
prehearing procedures, a hearing was held, beginning on June 29, 1993,
in San Francisco, California.
On April 21, 1994, Judge Bittner issued her opinion and recommended
ruling, findings of fact, conclusions of law and decision, recommending
that Respondent's DEA Certificate of Registration be revoked.
Respondent filed exceptions to the administrative law judge's decision
pursuant to 21 CFR 1316.66, and attached a Stipulation, Decision and
Order of the Medical Board of California (MBC), dated March 30, 1994,
which allowed Respondent to retain all controlled substance privileges
except that Respondent was prohibited from handling anabolic steroids
and was allowed to use Schedule II controlled substances only in a
hospital setting. The MBC order also placed Respondent's medical
license on probation for five years with various other conditions. The
Government filed a response to Respondent's exceptions.
On May 23, 1994, Judge Bittner transmitted the record of the
proceedings, including the Respondent's exceptions and the Government's
response thereto, to the Deputy Administrator. The Deputy Administrator
has carefully considered the record and adopts the opinion and
recommended decision of the administrative law judge in its entirety.
Pursuant to 21 CFR 1316.67, the Deputy Administrator hereby issues his
final order in this matter.
The Deputy Administrator finds that Respondent has had a solo
practice in family and emergency medicine since 1967. For a short time
in 1969 to 1971, he volunteered as a treating physician in a drug
addiction clinic. Sometime after this clinic closed in 1971, Respondent
continued to treat some of the former patients of this clinic in the
course of his general practice. At no time did Respondent ever posses a
DEA registration to operate a narcotic treatment program as required by
21 U.S.C. 823(g).
Respondent's treatment of drug addiction was not the subject of any
law enforcement investigation until 1988, when one of his patients was
arrested and found with prescription vials for Tylenol with codeine, a
Schedule III controlled substance, and Valium, a Schedule IV controlled
substance. The prescribing physician was Respondent. When asked about
these prescriptions, Respondent stated that they were issued to treat
the patient for heroin addiction. As a result, the California Bureau of
Narcotic Enforcement (BNE) commenced an investigation of Respondent's
medical practice.
In April 1988, a BNE undercover operative made her first visit to
Respondent's office and informed him that she was addicted to Ritalin
and that she also abused methamphetamine, a Schedule II controlled
substance. Respondent issued her a prescription for 60 dosage units of
Ritalin. She returned to Respondent's office three weeks later, seeking
a refill before her first Ritalin prescription should have expired.
Respondent complied by issuing her another prescription for 60 dosage
units of Ritalin. She made two more visits to Respondent's office
(about a month apart) and each time Respondent issued her another
Ritalin prescription, one for 50 dosage units and the other for 60
dosage units. She did not return to Respondent's office until May of
1989, at which time she saw Respondent's associate physician who
prescribed her only 8 dosage units of Ritalin to hold her until she
could see Respondent. Three days later, when she saw Respondent, he
decided not to reissue her a Ritalin prescription. Respondent, however,
suggested that she ``quit speed'' and use marijuana, a Schedule I
controlled substance, instead.
A patient who had been treated by Respondent with controlled
substances for drug addiction since 1974 agreed to act as an undercover
operative along with a police detective who posed as her boyfriend.
During their visit in April 1989, Respondent admonished the female
undercover operative for missing a prior appointment by stating,
``Where are you going to find a doctor doing what I am doing?''
Respondent did not issue her a Valium prescription as she requested,
but issued her a prescription for 40 dosage units of Restoril, a
Schedule IV controlled substance. Her medical bill indicated that the
prescription was issued for drug withdrawal.
Although the undercover detective was not seeking treatment,
Respondent asked him if he had any problems. When the detective
answered that he liked methamphetamine but that his drug problem was
not as bad as his girlfriend's addiction, Respondent wrote the
detective a prescription for 60 dosage units of Restoril. The detective
returned to Respondent's office less than a month later and again
stated that he was abusing methamphetamine. Respondent issued him
another prescription for 60 dosage units of Restoril and then asked the
detective if he shared the drugs with his girlfriend. When the
detective responded in the affirmative Respondent increased the
Restoril prescription to 80 dosage units. In addition, Respondent
dispensed 30 dosage units of Fastin, a Schedule IV controlled substance
used for diet control, to the detective. Respondent explained that he
wanted the detective to stop taking methamphetamine and instead use
``legal'' drugs.
Several of Respondent's patients were arrested in 1989. One was
arrested for driving under the influence of drugs. The day before her
arrest, Respondent had issued her a prescription for 100 dosage units
of Valium, a Schedule IV controlled substance, a prescription for 100
dosage units of Darvocet, a Schedule IV controlled substance, and a
prescription for 60 dosage units of Restoril. At the time of the arrest
only 50 dosage units of Valium and 73 dosage units of Darvocet remained
in the vials. Following the arrest, it was determined that the
individual was a drug addict whom Respondent was treating.
One of Respondent's employees stated that many of Respondent's
patients were drug addicts. This statement was confirmed when many of
Respondent's patient files were seized during a state criminal search
warrant executed at Respondent's office on October 17, 1989. The files
revealed that 150 patients who were addicts were being treated with
controlled substances; another 16 patients who were addicts were no
longer being treated by Respondent. Many of these patients continually
received controlled substances for a number of years. For example, one
patient received 4,005 dosage units of Tylenol with codeine #4, 2,330
dosage units of Valium 10 mg., and 900 dosage units of phenobarbital, a
Schedule IV controlled substance, between January 22, 1987, and October
12, 1989.
Respondent was interviewed about his treatment of drug addicts
during the execution of the October 1989 search warrant. Respondent
stated that patients were required to pay cash and that he determined
that certain individuals were drug addicts based upon physical
indications and discussions with his nurse, a former drug addict. He
admitted, however, that he did not perform blood or urine tests because
they were too expensive and did not keep any recovery logs for these
patients, to memorialize the quantity and length of time that drugs are
prescribed and what recovery programs the addict attends. Respondent
also disclosed that after he learned that some of his drug addict
patients were selling the drugs he prescribed, he raised his treatment
prices, so that his patients would have less financial incentive to
sell their drugs.
Two physician expert reports found that Respondent was not acting
in the course of professional medical practice by prescribing the
dosages of controlled substances that he did, especially when he was
aware that the patients were drug addicts.
The BNE investigation also focused on Respondent's prescribing and
dispensing of anabolic steroids. In June 1987, an investigator from the
then-California Board of Medical Quality Assurance (now MBC) had a
discussion with Respondent about allegations that Respondent dispensed
anabolic steroids to high school students. Respondent denied such
allegations and maintained that he lectured high school students on the
health hazards of using such substances. On April 3, 1989, a BNE
investigator also discussed the use of anabolic steroids with
Respondent. When Respondent opined that such substances could be
dispensed to enhance a person's physical appearance under close medical
supervision, the investigator informed him of the California statute
that classified anabolic steroids as controlled substances which became
effective in 1986. Respondent also stated that he was discontinuing the
dispensing and prescribing of anabolic steroids because he had heard
rumors that the police were planning to make an undercover purchase of
these substances from him.
The BNE investigation also revealed that Respondent was one of the
two highest purchasers of Anavar, an anabolic steroid, from a
particular supplier between 1985 and 1988. Some of Respondent's
employees divulged that Respondent prescribed, dispensed and
administered anabolic steroids out of his office to young adult males
for the purpose of body enhancement. These employees also disclosed
that Respondent required cash payments and that Respondent seldom
conducted blood tests on these individuals.
A police detective admitted that he had received steroids from
Respondent in 1988. Another officer, who also admitted to obtaining
anabolic steroids from Respondent for purposes of body enhancement,
indicated he used steroids based upon Respondent's recommendation.
While a BNE investigator was executing the search warrant at
Respondent's office on October 17, 1989, she encountered a patient who
was there to obtain anabolic steroids for body enhancement. The
individual explained to her that when he initially obtained steroids
from Respondent he was not warned about any dangers that accompanied
the use of such substances. He was only given one initial blood test by
Respondent.
Patient files recovered from Respondent's office revealed that many
had received steroids from Respondent since 1987. Few, if any, blood
tests were conducted on these patients. Another patient obtained
anabolic steroids from Respondent after the patient revealed that he
had taken these substances in the past, was depressed and attempted
suicide ten months earlier. There were ten patients who obtained
anabolic steroids from Respondent after April 3, 1989, the date when
Respondent was informed by a BNE investigator that anabolic steroids
were controlled substance under California law; one patient received
nine injections in May and June of 1989. The patient files revealed
that 97 patients received anabolic steroids from Respondent during the
three years preceding the execution of the search warrant and that
another 103 patients had previously received anabolic steroids from
Respondent.
A number of medical journal articles concerning the dangers of
continual anabolic steroid use were introduced into evidence. These
articles revealed that use of such substances was associated with
certain psychological problems such as irritability, violent
aggression, forgetfulness, confusion, abrupt mood swings and
depression. Such use also was correlated with physiological problems
such as decreased libido, insomnia, anorexia and metabolic
disturbances. Many of these problems were reversible if the patient
discontinued the use of these substances.
An expert physician reviewed Respondent's patient records and
concluded that 24 patients obtained anabolic steroids from Respondent
not for legitimate medical purposes. He opined that it was improper to
use anabolic steroids in conjunction with other controlled substances
prescribed by Respondent and that the steroids were particularly
contraindicated in light of some of the patients' medical illnesses.
The expert found that it was ``medically dangerous'' to give anabolic
steroids to a patient who had experienced prior depression.
Another expert physician testified on behalf of Respondent that the
doses of anabolic steroids that Respondent gave to his patients would
be considered therapeutic and modest compared to reported doses used by
athletes without a physician's authorization. This expert acknowledged,
however, that although it is ethical to monitor the use of anabolic
steroid use, it is not ethical for physicians to use such substances
for the purpose that Respondent used them and that he would try to
dissuade a patient from using anabolic steroids because ``* * * these
things are cheating in the world of sport * * *.'' Moreover, there
would be no way to determine if Respondent's patients were obtaining
additional steroids or other illicit drugs on the street. The expert
noted that if a physician is providing anabolic steroids, the physician
should weigh the individual and take his blood pressure on every visit.
In addition, the patient's lipid levels, cholesterol and triglycerides
should be measured on the first visit to establish a baseline.
Respondent's files demonstrated that, for the most part, this protocol
was not followed.
During execution of the search warrant, Respondent confirmed that
he dispensed anabolic steroids to his patients for purposes of body
enhancement. He explained that his services were necessary because if
he did not provide that patients with anabolic steroids they would
obtain the substances from the illicit market.
On May 30, 1991, in the Contra Costa County Court, State of
California, Respondent pled nolo contendere to and was convicted of six
felony counts of issuing controlled substance prescriptions without a
legitimate medical purpose. Respondent was placed on probation and
fined.
During execution of the search warrant, samples of various Schedule
II through V controlled substances were discovered in various locations
throughout Respondent's office, including Respondent's desk. There were
no records of receipts or dispensing for any of the controlled
substance samples as required by Federal law. There was only one
completed DEA 222 order form for fentanyl although Respondent also
possessed Demerol, another Schedule II controlled substance.
In evaluating whether Respondent's continued registration by the
Drug Enforcement Administration would be inconsistent with the public
interest, as that term is used in 21 U.S.C. 824(a)(4), the Deputy
Administrator considers the factors enumerated in 21 U.S.C. 823(f).
They are as follows:
(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.
In determining whether a registrant's continued registration is
inconsistent with the public interest, the Deputy Administrator is not
required to make findings with respect to each of the factors listed
above. Instead, the Deputy Administrator has the discretion to give
each factor the weight he deems appropriate, depending upon the facts
and circumstances of each case. See David E. Trawick, D.D.S., Docket
No. 88-69, 53 FR 5326 (1988).
The Deputy Administrator concurs with the opinion and recommended
ruling of the administrative law judge and finds that the second,
third, fourth and fifth factors apply. Respondent clearly provided
controlled substances to addicts to maintain their customary use. This
conclusion is not only supported by Respondent's patient files and the
information provided by Respondent and his employees, it is supported
by Respondent's conviction of six felony offenses in the State of
California.
Although Respondent acknowledged his treatment of addicts, he
argued that he had no knowledge that he was operating unlawfully and,
in any event, his treatment was effective. The administrative law judge
found that it is Respondent's duty to be aware of all applicable laws
and regulations. Walter S. Gresham, Docket No. 91-39, 57 FR 44213
(1992).
In addition, while there was some testimony from several of
Respondent's patients that his drug treatment helped them, the record,
for the most part, belies this contention. Respondent prescribed and
dispensed controlled substances without establishing any medical need
other than that the patient was an addict. Even if Respondent were
registered to operate a narcotic treatment program as required by 21
U.S.C. 823(g), the prescribing of narcotics would have been unlawful
pursuant to 21 CFR 1306.07(a).
Moreover, Respondent had little basis initially to verify that his
patients were drug addicts other than their word. He did nothing to
ensure that his patients abstained from controlled substances other
than those he prescribed and he took no steps to prevent diversion of
the controlled substances he supplied other than raising his price to
prevent diversion for economic gain. Although Respondent contended that
he was operating a detoxification program, many patients had been
obtaining controlled substances from Respondent for several years. One
patient was arrested for driving while under the influence of drugs
after apparently consuming large amounts of controlled substances
prescribed by Respondent on the previous day. The undercover visits
further reinforce the conclusion that Respondent did nothing to treat
his patients' addictions other than supply them with substitute
controlled substances. Respondent volunteered to prescribe controlled
substances for the undercover detective without seeking any information
about the detective's alleged drug use or past treatment. Respondent
did not offer the undercover detective any counseling and treatment and
the amount of the Restoril prescription was increased on the
detective's verbal assurances that he shared the Restoril with his
``girlfriend'' even though she was not present for this visit.
Respondent dispensed anabolic steroids in violation of applicable
state law. Again, Respondent did not deny dispensing the drugs but
maintained that he was unaware that it was illegal and that he
dispensed these substances in order to prevent his patients from
obtaining illicit steroids on the street. Respondent's discussion with
various state regulatory and law enforcement officers in 1987 and 1989
contradict this assertion. As was the case with Respondent's use of
controlled substances for drug addicts, he had a duty to know that his
conduct regarding steroids was unlawful. In addition to the above
violations, Respondent failed to keep any records of dispensing or
receipt of controlled substances located in his office with the sole
exception of one DEA 222 order form.
These violations represent a significant part of Respondent's
practice There is nothing in the record to indicate that Respondent
understood the grave consequences of his actions, other than
acknowledging that his conduct violated the law. Rather, Respondent
made great efforts to justify much of his unlawful conduct. Indeed,
Respondent did not cease his illegal conduct completely even after the
search warrant was served. The MBC Consent Decree in no way detracts
from these findings and conclusions. The Deputy Administrator has
considered Respondent's arguments submitted in his exceptions and finds
that the administrative law judge's findings of fact and conclusions of
law are amply supported by the record. Under these circumstances,
revocation of Respondent's DEA registration is the appropriate remedy
at this time.
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 (59 FR 23637), hereby orders
that DEA Certificate of Registration, AC8638085, previously issued to
John W. Copeland, be, and it hereby is, revoked, and any pending
applications for the renewal of such registration, be, and they hereby
are, denied. This order is effective October 6, 1994.
Dated: August 30, 1994.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 94-21829 Filed 9-2-94; 8:45 am]
BILLING CODE 4410-09-M
