|
|
during the year l987 were smoking marijuana medicinally. This is about
90 to 95 individuals. This number is higher than during the previous
ten years due to the nature of this physician's practice which includes
patients from the "tenderloin" area of San Francisco, many of whom are
suffering from AIDS-related lymphosarcoma. These patients smoke marijuana
to control their nausea and vomiting, not to "get high." They self-
titrate, i.e., smoke the marijuana only as long as needed to overcome
the nausea, to prevent vomiting.
21. The State of New Mexico set up a program in 1978 to make
marijuana available to cancer patients pursuant to an act of the State
legislature. The legislature had accepted marijuana as having medical
use in treatment. It overwhelmingly passed this legislation so as to
make marijuana available for use in therapy, not just for research.
Marijuana and synthetic THC were given to patients, administered under
medical supervision, to control or reduce emesis. The marijuana was in
the form of cigarettes obtained from the Federal government. The program
operated from 1979 until 1986, when funding for it was terminated by the
State. During those seven years about 250 cancer patients in New Mexico
received either marijuana cigarettes or THC. Twenty or 25 physicians in
New Mexico sought and obtained marijuana cigarettes or THC for their
cancer patients during that period. All of the oncologists in New Mexico
accepted marijuana as effective for some of their patients. At least ten
hospitals involved in this program in New Mexico, in which cancer
patients smoked their marijuana cigarettes. The hospitals accepted this
medicinal marijuana smoking by patients. Voluminous reports filed by the
participating physicians make it clear that marijuana is a highly
effective anti-emetic substance. It was found in the New Mexico program
to be far superior to the best available conventional
- 16 -
anti-emetic drug, compazine, and clearly superior to synthetic THC pills.
More than 90% of the patients who received marijuana within the New
Mexico program reported significant or total relief from nausea and
vomiting. Before the program began cancer patients were surreptitiously
smoking marijuana in New Mexico to lessen or control their emesis
resulting from chemotherapy treatments. They reported to physicians that
it was successful for this purpose. Physicians were aware that this was
going on.
22. In 1978 the Louisiana legislature became one of the first-
State legislatures in the nation to recognize the efficacy of marijuana
in controlling emesis by enacting legislation intended to make marijuana
available by prescription for therapeutic use by chemotherapy patients.
This enactment shows that there was widespread acceptance in Louisiana
of the therapeutic value of marijuana. After a State Marijuana
Prescription Review Board was established, pursuant to that legislation,
it became apparent that, because of Federal restrictions, marijuana could
be obtained legally only for use in cumbersome, formal research programs.
Eventually a research program was entered into by the State, utilizing
synthetic THC, but without much enthusiasm, since most professionals who
had wanted to use marijuana clinically, to treat patients, had neither
the time, resources nor inclination to get involved in this limited,
formal study. The original purpose of the Louisiana legislation was
frustrated by the Federal authorities. Some patients, who had hoped to
obtain marijuana for medical use legally after enactment of the State
legislation, went outside the law and obtained it illicitly. Some
physicians in Louisiana accept marijuana as having a distinct medical
value in the treatment of the nausea and vomiting associated with certain
types of chemotherapy treatments.
- 17 -
23. In 1980 the State of Georgia enacted legislation
authorizing a therapeutic research program for the evaluation of
marijuana as a medically recognized therapeutic substance. Its enactment
was supported by letters from a number of Georgia oncologist and other
Georgia physician, including the Chief of oncology at Grady Hospital and
staff oncologist at Emory University Medical Clinic. Sponsors of the
legislation originally intended the enactment of a law making marijuana
available for clinical, therapeutic use by patients. The bill was
referred to as the "Marijuana-as-Medicine" bill. The final legislation
was crafted, however, of necessity, merely to set up a research program
in order to obtain marijuana from the one legitimate source available -
the Federal Government, which would not make the substance available for
any other purpose other than conducting a research program. The act was
passed by an overwhelming majority in the lower house of the legislature
and unanimously in the Senate. In January 1983 an evaluation of the
program, which by then had 44 evaluable marijuana smoking patient-
participants, accepted marijuana smoking as being an effective anti-
emetic agent.
24. In Boston, Massachusetts in 1977 a nurse in a hospital
suggested to a chemotherapy patient, suffering greatly from the therapy
and at the point of refusing further treatment, that smoking marijuana
might help relieve his nausea and vomiting. The patient's doctor, when
asked about it later, stated that many of his younger patients were
smoking marijuana. Those who did so seemed to have less trouble with
nausea and vomiting. The patient in question obtained some marijuana and
smoked it, in the hospital, immediately before his next chemotherapy
treatment. Doctors, nurses, and orderlies coming into the room as he
finished smoking realized what the patient had been doing. None of them
- 18 -
made any comment. The marijuana was completely successful with this
patient, who accepted it as effective in controlling his nausea and
vomiting. Instead of being sick for weeks following chemotherapy, and
having trouble going to work, as had been the case, the patient was ready
to return to work 48 hours after that chemotherapy treatment. The
patient thereafter always smoked marijuana, in the hospital, before
chemotherapy. The doctors were aware of it, openly approved of it and
encouraged him to continue. The patient resumed eating regular meals and
regained lost eight, his mood improved markedly, he became more active
and outgoing and began doing things together with his wife that he had
not done since beginning chemotherapy.
25. During the remaining two years of this patient's life,
before his cancer ended it, he came to know other cancer patients who
were smoking marijuana to relieve the adverse effects of their
chemotherapy. Most of these patients had learned about using marijuana
medically from their doctors who, having accepted its effectiveness,
subtly encouraged them to use it.
26. A Boston psychiatrist and professor, who travels about the
country, has found a minor conspiracy to break the law among oncologists
and nurses in every oncology center he has visited to let patients smoke
marijuana before and during cancer chemotherapy. He has talked with
dozens of these health care oncologists who encourage their patients to
do this and who regard this as an accepted medical usage of marijuana.
He has known nurses who have obtained marijuana for patients unable to
obtain it for themselves.
27. A cancer patient residing in Beaverton, Michigan smoked
marijuana medicinally in the nearby hospital where he was undergoing
chemotherapy from early 1979 until he died of his cancer in October of
that year. He smoked it in
- 19 -
his hospital room after his parents made arrangements with the hospital
for him to do so. Smoking marijuana controlled his post-chemotherapy
nausea and vomiting, enabled him to eat regular-meals again with his
family, and he became outgoing and talkative. His parents accepted his
marijuana smoking as effective and helpful. Two clergymen, among others,
brought marijuana to this patient's home. Many people at the hospital
supported the patient's marijuana therapy, none doubted its helpfulness
or discouraged it. This patient was asked for help by other patients.
He taught some who lived nearby how to form the marijuana cigarettes and
properly inhale the smoke to obtain relief from nausea and vomiting.
When an article about this patient's smoking marijuana appeared in a
local newspaper, he and his family heard from many other cancer patients
who were doing the same. Most of them made an effort to inform their
doctors. Most Physicians who knew their patients smoked marijuana
medicinally approved, accepting marijuana's therapeutic helpfulness in
reducing nausea and vomiting.
28. In October 1979 the Michigan legislature enacted
legislation whose underlying purpose was to make marijuana available
therapeutically for cancer patients and others. The State Senate passed
the bill 29-5, the House of Representatives 100-0. In March 1982 the
Michigan legislature passed a resolution asking the Federal Congress to
try to alter Federal policies which prevent physicians from prescribing
marijuana for legitimate medical applications and prohibit its use in
medical treatments.
29. In Denver, Colorado a teenage cancer patient has been
smoking marijuana to control nausea and vomiting since 1986. He has done
this in his hospital room both before and after chemotherapy. His doctor
and hospital staff know he does this. The doctor has stated that he
would prescribe marijuana for
- 20 -
this patient if it were legal to do so. Other patients in the Denver
area smoke marijuana for the same purpose. This patient's doctor, and
nurses with whom he comes in contact, understand that cancer patients
smoke marijuana to reduce or control emesis. They accept it.
30. In late 1980 a three year old boy was brought by his
parents to a hospital in Spokane, Washington. The child was diagnosed as
having cancer. Surgery was performed. Chemotherapy was begun. The
child became extremely nauseated and vomited for days after each
chemotherapy treatment. He could not eat regularly. He lost strength.
He lost weight. His body's ability to ward off common infections, other
life-threatening infections, significantly decreased. Chemotherapy's
after-effects caused the child great suffering. They caused his watching
parents great suffering. Several standard, available anti-emetic agents
were tried by the child's doctors. None of them succeeded in controlling
his nausea or vomiting. Learning of the existence of research studies
with THC or marijuana the parents asked the child's doctor to arrange for
their son to be the subject of such a study so that he might have access
to marijuana. The doctor refused, citing the volume of paperwork and
record-keeping detail required in such programs and his lack of
administrative personnel to handle it.
31. The child's mother read an article about marijuana smoking
helping chemotherapy patients. She obtained some marijuana from friends.
She baked cookies for her child with marijuana in them. She made tea for
him with marijuana in it. When the child ate these cookies or drank this
tea in connection with his chemotherapy, he did not vomit. His strength
returned. He regained lost weight. His spirits revived. The parents
told the doctors and nurses at the hospital of their giving marijuana to
their child. None objected.
- 21 -
They all accepted smoking marijuana as effective in controlling
chemotherapy induced nausea and vomiting. They were interested to see
the results of the cookies.
32. Soon this child was riding a tricycle in the hallways of
the Spokane hospital shortly after his chemotherapy treatments while
other children there were still vomiting into pans, tied to intravenous
bottles in an attempt to re-hydrate them, to replace the liquids they
were vomiting up. Parents of some of the other patients asked the
parents of this "lively" child how he seemed to tolerate his chemotherapy
so well. They told of the marijuana use. Of those parents who began
giving marijuana to their children, none ever reported back encountering
any adverse side effects. In the vast majority of these cases, the other
parents reported significant reduction in their children's vomiting and
appetite stimulation as the result of marijuana. The staff, doctors and
nurses at the hospital knew of this passing on of information about
marijuana to other parents. They approved. They never told the first
parents to hide their son's medicinal use of marijuana. They accepted
the effectiveness of the cookies and the tea containing marijuana.
33. The first child's cancer went into remission. Then it
returned and spread. Emotionally drained, the parents moved the family
back to San Diego, California to be near their own parents. Their son
was admitted to a hospital in San Diego. The parents informed the
doctors, nurses and social workers there of their son's therapeutic use
of marijuana. No one objected. The child's doctor in San Diego strongly
supported the parent's giving marijuana to him. Here in California, as
in Spokane, other parents noticed the striking difference between their
children after chemotherapy and the first child.
- 22 -
Other parents asked the parents of the first child about it, were told of
the use of marijuana, tried it with their children, and saw dramatic
improvement. They accepted its effectiveness. In the words of the
mother of the first child: ". . . When your kid is riding a tricycle
while his other hospital buddies are hooked up to IV needles, their heads
hung over vomiting buckets, you don't need a federal agency to tell you
marijuana is effective. The evidence is in front of you, so stark it
cannot be ignored." [footnote 6]
34. There is at least one hospital in Tucson, Arizona where
medicinal use of marijuana by chemotherapy patients is encouraged by the
nursing staff and some physicians.
35. In addition to the physicians mentioned in the Findings
above, mostly oncologists and other practitioners, the following doctors
and health care professionals, representing several different areas of
expertise, accept marijuana as medically useful in controlling or
reducing emesis and testified to that effect in these proceedings:
a. George Goldstein, Ph.D., psychologist, Secretary of
Health for the State of New Mexico from 1978 to 1983 and chief
administrator in the implementation of the New Mexico program utilizing
marijuana;
b. Dr. Daniel Danzak, psychiatrist and former head of the
New Mexico program utilizing marijuana;
c. Dr. Tod Mikuriya, psychiatrist and editor of
Marijuana: Medical Papers, a book presenting an historical perspective of
marijuana's medical use;
d. Dr. Norman Zinberg, general psychiatrist and Professor
of Psychiatry at Harvard Medical School since 1951;
____________________
6 Affidavit of Janet Andrews, ACT rebuttal witness, par. 98.
- 23 -
e. Dr. John Morgan, psychopharmacologist, Board-certified
in Internal Medicine, full Professor and Director of Pharmacology at the
City University of New York;
f. Dr. Phillip Jobe, neuropsychopharmacologist with a
practice in Illinois and former Professor of Pharmacology and Psychiatry
at the Louisiana State University School of Medicine in Shreveport,
Louisiana, from 1974 to 1984;
g. Dr. Arthur Kaufman, formerly a general practitioner in
Maryland, currently Vice-President of a private medical consulting group
involved in the evaluation of the quality of care of all the U.S.
military hospitals throughout the world, who has had extensive experience
in drug abuse treatment and rehabilitation programs;
h. Dr. J. Thomas Ungerleider, a full Professor of
Psychiatry at the University of California in Los Angeles with extensive
experience in research on the medical use of drugs;
i. Dr. Andrew Weil, ethnopharmacologist, Associate
Director of Social Perspectives in Medicine at the College of Medicine at
the University of Arizona, with extensive research on medicinal plants;
and
j. Dr. Lester Grinspoon, a practicing psychiatrist and
Associate Professor at Harvard Medical School.
36. Certain law enforcement authorities have been outspoken in
their acceptance of marijuana as an antiemetic agent. Robert T. Stephan,
Attorney General of the State of Kansas, and himself a former cancer
patient, said of chemotherapy in his affidavit in this record: "The
treatment becomes a terror." His cancer is now in remission. He came to
know a number of health care professionals whose medical judgment he
respected. They had accepted marijuana
- 24 -
as having medical use in treatment. He was elected Vice President of the
National Association of Attorneys General (NAAG) in 1983. He was
instrumental in the adoption by that body in June 1983 of a resolution
acknowledging the efficacy of marijuana for cancer and glaucoma patients.
The resolution expressed the support of NAAG for legislation then pending
in the Congress to make marijuana available on prescription to cancer and
glaucoma patients. The resolution was adopted by an overwhelming margin.
NAAG's President, the Attorney General of Montana, issued a statement
that marijuana does have accepted medical uses and is improperly
classified at present. The Chairman of NAAG's Criminal Law and Law
Enforcement Committee, the Attorney General of Pennsylvania, issued a
statement emphasizing that the proposed rescheduling of marijuana would
in no way affect or impede existing efforts by law enforcement
authorities to crack down on illegal drug trafficking.
37. At least one court has accepted marijuana as having medical
use in treatment for chemotherapy patients. On January 23, 1978 the
Superior Court of Imperial County, California issued orders authorizing a
cancer patient to possess and use marijuana for therapeutic purposes
under the direction of a physician. Another order authorized and
directed the Sheriff of the county to release marijuana from supplies on
hand and deliver it to that patient in such form as to be usable in the
form of cigarettes.
38. During the period 1978-1980 polls were taken to ascertain
the degree of public acceptance of marijuana as effective in treating
cancer and glaucoma patients. A poll in Nebraska brought slightly over
1,000 responses - 83% favored making marijuana available by prescription,
12% were opposed, 5% were undecided. A poll in Pennsylvania elicited
1,008 responses - 83.1% favored availability by prescription, 12.2% were
opposed, 4.7% were undecided. These
- 25 -
two surveys were conducted by professional polling companies. The
Detroit Free Press conducted a telephone poll in which 85.4% of those
responding favored access to marijuana by prescription. In the State of
Washington the State Medical Association conducted a poll in which 80% of
the doctors belonging to the Association favored controlled availability
of marijuana for medical purposes.
Discussion
From the foregoing uncontroverted facts it is clear beyond any
question that many people find marijuana to have, in the words of the
Act, an "accepted medical use in treatment in the United States" in
effecting relief for cancer patients. Oncologists, physicians treating
cancer patients, accept this. Other medical practitioners and
researchers accept this. Medical faculty professors accept it. Nurses
performing hands-on patient care accept it.
Patients accept it. As counsel for CCA perceptively pointed out at
oral argument, acceptance by the patient is of vital importance. Doctors
accept a therapeutic agent or process only if it "works" for the patient.
If the patient does not accept, the doctor cannot administer the
treatment. The patient's informed consent is vital. The doctor
ascertains the patient's acceptance by observing and listening to the
patient. Acceptance by the doctor depends on what he sees in the patient
and hears from the patient. Unquestionably, patients in large numbers
have accepted marijuana as useful in treating their emesis. They have
found that it "works". Doctors, evaluating their patients, can have
no basis more sound than that for their own acceptance.
Of relevance, also, is the acceptance of marijuana by state
attorneys-
- 26 -
general, officials whose primary concern is law enforcement. A large
number of them have no fear that placing marijuana in Schedule II, thus
making it available for legitimate therapy, will in any way impede
existing efforts of law enforcement authorities to crack down on illegal
drug trafficking.
The Act does not specify by whom a drug or substance must be
"accepted [for] medical use in treatment" in order to meet the Act's
"accepted" requirement for placement in Schedule II. Department of
Justice witnesses told the Congress during hearings in 1970 preceding
passage of the Act that "the medical Profession" would make this
determination, that the matter would be "determined by the medical
community." The Deputy Chief Counsel of BNDD, whose office had written
the bill with this language in it, told the House subcommittee that "this
basic determination . . . is not made by any part of the federal
government. It is made by the medical community as to whether or not the
drug has medical use or doesn't". [footnote 7]
No one would seriously contend that these Justice Department
witnesses meant that the entire medical community would have to be in
agreement on the usefulness of a drug or substance. Seldom, if ever, do
all lawyers agree on a point of law. Seldom, if ever, do all doctors
agree on a medical question. How many are required here? A majority of
51%? It would be unrealistic to attempt a plebiscite of all doctors in
the country on such a question every time it arises, to obtain a majority
vote.
In determining whether a medical procedure utilized by a doctor is
actionable as malpractice the courts have adopted the rule what it is
acceptable
____________________
7 Drug Abuse Control Amendments - 1970: Hearings on H.R. 11701 and
H.R. 13743 Before the Subcommittee on Public Health and Welfare of
the House Committee on Interstate and Foreign Commerce, 91st
Congress, 2d Sess. 678, 696, 718 (1970) (Statement of John E.
Ingersoll, Director, BNDD).
- 27 -
for a doctor to employ a method of treatment supported by a respectable
minority of physicians.
In Hood v. Phillips, 537 S.W. 2d 291 (1976) the Texas Court of Civil
Appeals was dealing with a claim of medical malpractice resulting from a
surgical procedure claimed to have been unnecessary. The court quoted
from an Arizona court decision holding that
a method of treatment, as espoused and used by . . . a
respectable minority of physicians in the United States,
cannot be said to be an inappropriate method of treat-
ment or to be malpractice as a matter of law even though
it has not been accepted as a proper method of treatment
by the medical profession generally.
Ibid. at 294. Noting that the Federal District court in the Arizona case
found a "respectable minority" composed of sixty-five physicians
throughout the United States, the Texas court adopted as "the better
rule" to apply in its case, that
a physician is not guilty of malpractice where the
method of treatment used is supported by a respect-
able minority of physicians.
Ibid.
In Chumbler v. McClure, 505 F.2d 489 (6th Cir. 1974) the Federal
courts were dealing with a medical malpractice case under their diversity
jurisdiction, applying Tennessee law, The Court of Appeals said:
. . . The most favorable interpretation that may be
placed on the testimony adduced at trial below is
that there is a division of opinion in the medical
profession regarding the use of Premarin in the Treat-
ment of cerebral vascular insufficiency, and that Dr.
McClure was alone among neurosurgeons in Nashville in
using such therapy. The test for malpractice and for
community standards is not to be determined solely by
a plebiscite. Where two or more schools of thought
exist among competent members of the medical profes-
sion concerning proper medical treatment for a given
ailment, each of which is supported by responsible
- 28 -
medical authority, it is not malpractice to be among
the minority in a given city who follow: one of the
accepted schools.
505 F.2d at 492 (Emphasis added). See, also, Leech v. Bralliar, 275
F.Supp. 897 (D.Ariz., 1967).
How do we ascertain whether there exists a school of thought
supported by responsible medical authority, and thus "accepted"? We
listen to the physicians.
The court and jury must have a standard measure
which they are to use in measuring the acts of a
doctor to determine whether he exercised a reasonable
degree of care and skill; they are not permitted to
set up and use any arbitrary or artificial standard
of measurement that the jury may wish to apply. The
proper standard of measurement is to be established
by testimony of physicians, for it is a medical
question.
Hayes v. Brown, 133 S.E. 2d. 102 (Ga., 1963) at 105.
As noted above, there is no question but that this record shows a
great many physicians, and others, to have "accepted" marijuana as having
a medical use in the treatment of cancer patients' emesis. True, all
physicians have not "accepted" it. But to require universal, 100%
acceptance would be unreasonable. Acceptance by "a respectable minority"
of physicians is all that can reasonably be required. The record here
establishes conclusively that at least "a respectable minority" of
physicians has "accepted" marijuana as having a "medical use in treatment
in the United states." That others may not makes no difference.
The administrative law judge recommended this same approach for
determining whether a drug has an "accepted medical use in treatment" in
The Matter Of MDMA Scheduling, Docket No. 84-48. The Administrator, in
his first final rule in that proceeding, issued on October 8, 1986
[footnote 8], declined to adopt this approach. He
____________________
8 51 Fed. Reg. 36552 (1986).
- 29 -
ruled, instead, that DEA's decision on whether or not a drug or other
substance had an accepted medical use in treatment in the United States
would be determined simply by ascertaining whether or not "the drug or
other substance is lawfully marketed in the United States pursuant to
the Federal Food, Drug and Cosmetic Act of 1938 . . . ." [footnote 9]
The United States Court of Appeals for the First Circuit held that
the Administrator erred in so ruling. [footnote 10] That court vacated
the final order of October 8, 1986 and remanded the matter of MDMA's
scheduling for further consideration. The court directed that, on
remand, the Administrator would not be permitted to treat the absence of
interstate marketing approval by FDA as conclusive evidence on the
question of accepted medical use under the Act.
In his third final rule [footnote 11] of the matter of the
scheduling of MDMA the Administrator made a series of findings of fact as
to MDMA, the drug there under consideration, with respect to the evidence
in that record. On those findings he based his last final rule in the
case. [footnote 12]
____________________
9 Ibid., at 36558.
10 Grinspoon v. Drug Enforcement Administration, 828 F.2d 881 (1st.
Cir., 1987).
11 53 Fed. Reg. 5156 (1988). A second final rule had been issued on
January 20, 1988. It merely removed MDMA from Schedule I pursuant
to the mandate of the Court of Appeals which had voided the first
final rule placing it there. Subsequently the third final rule was
issued, without any further hearings, again placing MDMA in Schedule
I. There was no further appeal.
12 In neither the first nor the third final rule in the MDMA case does
the Administrator take any cognizance of the statements to the
Congressional committee by predecessor Agency officials that the
determination as to "accepted medical use in treatment" is to be
made by the medical community and not by any part of the federal
government. See page 27, above. It is curious that the
administrator makes no effort whatever to show how the BNDD
representatives were mistaken or to explain why he now has abandoned
their interpretation. They wrote that language into the original
bill.
- 30 -
That third final rule dealing with MDMA is dealing with a synthetic,
"simple", "single-action" drug. What might be appropriate criteria for a
"simple" drug like MDMA may not be appropriate for a "complex" substance
with a number of active components. The criteria applied to MDMA, a
synthetic drug, are not appropriate for application to marijuana, which
is a natural plant substance.
The First Circuit Court of Appeals in the MDMA case told the
Administrator that he should not treat the absence of FDA interstate
marketing approval as conclusive evidence of lack of currently accepted
medical use. The court did not forbid the Administrator from considering
the absence of FDA approval as a factor when determining the existence of
accepted medical use. Yet on remand, in his third final order, the
Administrator adopted by reference 18 of the numbered findings he had
made in the first final order. Each of these findings had to do with
requirements imposed by FDA for approval of a new drug application (NDA)
or of an investigational new drug exemption (IND). These requirements
deal with data resulting from controlled studies and scientifically
conducted investigations and test.
Among those findings incorporated into the third final MDMA order
from the first, and relied on by the Administrator, was the determination
and recommendation of the FDA that the drug there in question was not
"accepted". In relying on the FDA's action the Administrator apparently
overlooked the fact that the FDA clearly stated that it was interpreting
"accepted medical use" in the Act as being equivalent to receiving FDA
approval for lawful marketing under the FDCA. Thus the Administrator
accepted as a basis for his MDMA third final rule the FDA recommendation
which was based upon a statutory interpretation which the Court
- 31 -
of Appeals had condemned.
The Administrator in that third final rule made a series of further
findings. Again, the central concern in these findings was the content
of test results and the sufficiency or adequacy of studies and scientific
reports. A careful reading of the criteria considered in the MDMA third
final order reveals that the Administrator was really considering the
question: Should the drug be accepted for medical use?; rather than the
question: Has the drug been accepted for medical use? By considering
little else but scientific test results and reports the Administrator
was making a determination as to whether or not, in his opinion, MDMA
ought to be accepted for medical use in treatment.
The Agency's arguments in the present case are to the same effect.
In a word, they address the wrong question. It is not for this Agency to
tell doctors whether they should or should not accept a drug or substance
for medical use. The statute directs the Administrator merely to
ascertain whether, in fact, doctors have done so.
The MDMA third final order mistakenly looks to FDA criteria for
guidance in choosing criteria for DEA to apply. Under the Food, Drug and
Cosmetic Act the FDA is deciding - properly, under that statute - whether
a new drug should be introduced into interstate commerce. Thus it is
appropriate for the FDA to rely heavily on test results and scientific
inquiry to ascertain whether a drug is effective and whether it is safe.
The FDA must look at a drug and pass judgment on its intrinsic
qualities. The DEA, on the other hand, is charged by 21 U.S.C. §
812(b)(1)(B) and (2)(B) with ascertaining what it is that other people
have done with respect to a drug or substance: "Have they accepted it?;"
not "Should they accept it?"
- 32 -
In the MDMA third final order DEA is actually making the decision
that doctors have to make, rather than trying to ascertain the decision
which doctors have made. Consciously or not, the Agency is undertaking
to tell doctors what they should or should not accept. In so doing the
Agency is acting beyond the authority granted in the Act.
It is entirely proper for the Administrator to consider the
pharmacology of a drug and scientific test results in connection with
determining abuse potential. But abuse potential is not in issue in this
marijuana proceeding.
There is another reason why DEA should not be guided by FDA criteria
in ascertaining whether or not marijuana has an accepted medical use in
treatment. These criteria are applied by FDA pursuant to Section 505 of
the Federal Food, Drug and Cosmetic Act (FDCA), as amended. [footnote 13]
When the FDA is making an inquiry pursuant to that legislation it is
looking at a synthetically formed new drug. The marijuana plant is
anything but a new drug. Uncontroverted evidence in this record
indicates that marijuana was being used therapeutically by mankind 2000
years before the Birth of Christ. [footnote 14]
Uncontroverted evidence further establishes that in this country
today "new drugs" are developed by pharmaceutical companies possessing
resources sufficient to bear the enormous expense of testing a new drug,
obtaining FDA approval of its efficacy and safety, and marketing it
successfully. No company undertakes the investment required unless it
has a patent on the drug, so it can recoup its development costs and make
a profit. At oral argument Government counsel conceded that "the FDA
system is constructed for pharmaceutical companies. I won't
____________________
13 21 U.S.C. § 355.
14 Alice M. O'Leary, direct, par. 9.
- 33 -
deny that." [footnote 15]
Since the substance being considered in this case is a natural plant
rather than a synthetic drug, it is unreasonable to make FDA-type
criteria determinative of the issue in this case, particularly so when
such criteria are irrelevant to the question posed by the act: does the
substance have an accepted medical use in treatment?
Finally, the Agency in this proceeding relies in part on the FDA's
recommendation that the Administrator retain marijuana in Schedule I.
But, as in the MDMA case, that recommendation is based upon FDA's
equating "accepted medical use" under the Act with being approved for
marketing by FDA under the Food, Drug and Cosmetic Act, the
interpretation condemned by the First Circuit in the MDMA case. See
Attachment A, p.24, to exhibit G-1 and exhibit G-2.
The overwhelming preponderance of the evidence in this record
establishes that marijuana has a currently accepted medical use in
treatment in the United States for nausea and vomiting resulting from
chemotherapy treatments in some cancer patients. To conclude otherwise,
on this record, would be unreasonable, arbitrary and capricious.
____________________
15 Tr. XV-37.
- 34 -
|
