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VI.
ACCEPTED MEDICAL USE IN TREATMENT
- GLAUCOMA
Findings of Fact
The preponderance of the evidence establishes the following facts
with respect to the accepted medical use of marijuana in the treatment of
glaucoma.
1. Glaucoma is a disease of the eye characterized by the
excessive accumulation of fluid causing increased intraocular pressure,
distorted vision and, ultimately, blindness. In its early stages this
pressure can sometimes be relieved by the administration of drugs. When
such medical treatment fails adequately to reduce the intraocular
pressure (IOP), surgery is generally resorted to. Although useful in
many cases, there is a high incidence of failure with some types of
surgery. Further, serious complications can occur as a result of
invasive surgery. Newer, non-invasive procedures such as laser
trabeculoplasty are thought by some to offer much greater efficacy with
fewer complications. Unless the IOP is relieved and brought to a
satisfactory level by one means or another, the patient will go blind.
2. Two highly qualified and experienced ophthalmologists in
the United States have accepted marijuana as having a medical use in
treatment for glaucoma. They are John C. Merritt, M.D. and Richard D.
North, M.D. Each of them is both a clinician, treating patients, and a
researcher. Dr. Merritt is also a professor of ophthalmology. Dr. North
has served as a medical officer in ophthalmology for the Department of
Health, Education and Welfare and has worked with the Public Health
Service and FDA.
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3. Dr. Merritt's experience with glaucoma patients using
marijuana medicinally includes one Robert Randall and, insofar as the
evidence here establishes per petitioners' briefs, an unspecified number
of other patients, something in excess of 40.
4. Dr. North has treated only one glaucoma patient using
marijuana medicinally - the same Robert Randall mentioned immediately
above. Dr. North had monitored Mr. Randall's medicinal use of marijuana
for nine years as of May 1987
5. Dr. Merritt has accepted marijuana as having an important
place in the treatment of "End Stage" glaucoma. "End Stage" glaucoma,
essentially, defines a patient who has already lost substantial amounts
of vision; available glaucoma control drugs are no longer able adequately
to reduce the intraocular pressure (IOP) to prevent further, progressive
sight loss; the patient, lacking additional IOP reductions, will go
blind.
6. Robert S. Hepler, M.D., is a highly qualified and
experienced ophthalmologist. He has done research with respect to the
effect of smoking marijuana on glaucoma. In December 1975 he prescribed
marijuana for the same Robert Randall mentioned above as a research
subject. Dr. Hepler found that large dosages of smoked marijuana
effectively reduced Robert Randall's IOP into the safe range over an
entire test day. He concluded that the only known alternative to
preserve Randall's sight which would avoid the significant risks of
surgery is to include marijuana as part of Randall's prescribed medical
regimen. He further concluded in 1977 that, if marijuana could have been
legally prescribed, he would have prescribed it for Randall as part of
Randall's regular glaucoma maintenance program had he been Randall's
personal physician.
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Nonetheless, in 1987 Dr. Hepler was of the opinion that marijuana did
not have a currently accepted medical use in the United States for the
treatment of glaucoma.
7. Four glaucoma patients testified in these proceedings.
Each has found marijuana to be of help in controlling IOP.
8. In 1984 the treatment of glaucoma with Cannabis was the
subject of an Ophthalmology Grand Rounds at the University of California,
San Francisco. A questionnaire was distributed which queried the
ophthalmologists on cannabis therapy for glaucoma patients refractory to
standard treatment. Many of them have glaucoma patients who have asked
about marijuana. Most of the responding ophthalmologists believed that
THC capsules or smoked marijuana need to be available for patients who
have not benefited significantly from standard treatment.
9. In about 1978 an unspecified number of persons in the
public health service sector in New Mexico, including some physicians,
accepted marijuana as having medical use in treating glaucoma.
10. A majority of an unspecified number of ophthalmologists
known to Arthur Kaufman, M.D., who was formerly in general practice but
now is employed as a medical program administrator, accept marijuana as
having medical use in treatment of glaucoma.
11. In addition to the physicians identified and referred to in
the findings above, the testimony of patients in this record establishes
that no more than three or four other physicians consider marijuana to be
medically useful in the treatment of glaucoma in the United States. One
of those Physicians actually wrote a prescription for marijuana for a
patient, which, of course, she was unable to have filled.
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12. There are test results showing that smoking marijuana has
reduced the IOP in some glaucoma patients. There is continuing research
underway in the United States as to the therapeutic effect of marijuana
on glaucoma.
Discussion
Petitioners' briefs fail to show that the preponderance of the
evidence in the record with respect to marijuana and glaucoma establishes
that a respectable minority of physicians accepts marijuana as being
useful in the treatment of glaucoma in the United States.
This conclusion is not to be taken in any way as criticism of the
opinions of the ophthalmologists who testified that they accept marijuana
for this purpose. The failure lies with petitioners. In their briefs
they do not point out hard, specific evidence in this record sufficient
to establish that a respectable minority of physicians has accepted their
position.
There is a great volume of evidence here, and much discussion in the
briefs, about the protracted case of Robert Randall. But when all is
said and done, his experience presents but one case. The record contains
sworn testimony of three ophthalmologists who have treated Mr. Randall.
One of them tells us of a relatively small number of other glaucoma
patients whom he has treated with marijuana and whom he knows to have
responded favorably. Another of these three doctors has successfully
treated only Randall with marijuana. The third testifies, despite his
successful experience in treating Randall, that marijuana does not have
an accepted use in such treatment.
In addition to Robert Randall, Petitioners point to the testimony of
three other glaucoma patients. Their case histories are impressive, but
they contribute
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little to the carrying of Petitioner's burden of showing that marijuana
is accepted for medical treatment of glaucoma by a respectable minority
of physicians. See pages 26-29, above.
Petitioners have in evidence copies of a number of newspaper
clippings reporting statements by persons claiming that marijuana has
helped their glaucoma. The administrative law judge is unable to give
significant weight to this evidence. Had these persons testified so as
to have been subject to cross-examination, a different situation would be
presented. But these newspaper reports of extra-judicial statements,
neither tested by informed inquiry nor supported by a doctor's opinion,
are not entitled to much weight. They are of little, if any,
materiality.
Beyond the evidence referred to above there is a little other "hard"
evidence, pointed out by petitioners, of Physicians accepting marijuana
for treatment of glaucoma. Such evidence as that concerning a survey of
a group of San Francisco ophthalmologists is ambiguous, at best. The
relevant document establishes merely that most of the doctors on the
grand round, who responded to an inquiry, believed that the THC capsules
or marijuana ought to be available.
In sum, the evidence here tending to show that marijuana is accepted
for treatment of glaucoma falls far, far short of quantum of evidence
tending to show that marijuana is accepted for treatment of emesis in
cancer patients. The preponderance of the evidence here, identified by
petitioners in their briefs, does not establish that a respectable
minority of physicians has accepted marijuana for glaucoma treatment.
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VII.
ACCEPTED MEDICAL USE IN TREATMENT
- MULTIPLE SCLEROSIS, SPASTICITY
AND HYPERPARATHYROIDISM
Findings Of Fact
The preponderance of the evidence clearly establishes the following
facts with respect to marijuana's use in connection with multiple
sclerosis, spasticity and hyperparathyroidism.
1. Multiple sclerosis is the major cause of neurological
disability among young and middle-aged adults in the United States today.
It is a life-long disease. It can be extremely debilitating to some of
its victims but it does not shorten the life span of most of them. Its
cause is yet to be determined. It attacks the myelin sheath, the coating
or insulation surrounding the message-carrying nerve fibers in the brain
and spinal cord. Once the myelin sheath is destroyed, it is replaced by
plaques of hardened tissue known as sclerosis. During the initial stages
of the disease nerve impulses are transmitted with only minor
interruptions. As the disease progresses, the plaques may completely
obstruct the impulses along certain nerve systems. These obstructions
produce malfunctions. The effects are sporadic in most individuals and
the effects often occur episodically, triggered either by malfunction of
the nerve impulses or by external factors.
2. Over time many patients develop spasticity, the involuntary
and abnormal contraction of muscle or muscle fibers. (Spasticity can
also result from serious injuries to the spinal cord, not related to
multiple sclerosis.)
3. The symptoms of multiple sclerosis vary according to the
area of
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the nervous system which is affected and according to the severity of the
disease. The symptoms can include one or more of the following:
weakness, tingling, numbness, impaired sensation, lack of coordination,
disturbances in equilibrium, double vision, loss of vision, involuntary
rapid movement of the eyes (nystagmus), slurred speech, tremors,
stiffness, spasticity, weakness of limbs, sexual dysfunction, paralysis,
and impaired bladder and bowel functions.
4. Each person afflicted by multiple sclerosis is affected
differently. In some persons, the symptoms of the disease are barely
detectable, even over long periods of time. In these cases, the persons
can live their lives as if they did not suffer from the disease. In
others, more of the symptoms are present and acute, thereby limiting
their physical capabilities. Moreover, others may experience sporadic,
but acute, symptoms.
5. At this time, there is no known prevention or cure for
multiple sclerosis. Instead, there are only treatments for the symptoms
of the disease. There are very few drugs specifically designed to treat
spasticity. These drugs often cause very serious side effects. At the
present time two drugs are approved by FDA as "safe" and "effective" for
the specific indication of spasticity. These drugs are Dantrium and
Lioresal baclofen.
6. Unfortunately, neither Dantrium nor Lioresal is a very
effective spasm control drug. Their marginal medical utility, high
toxicity and potential for serious adverse effects make these drugs
difficult to use in spasticity therapy.
7. As a result, many physicians routinely prescribe
tranquilizers, muscle relaxants, mood elevators and sedatives such as
Valium to patients experiencing spasticity. While these drugs do not
directly reduce spasticity
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they may weaken the patient's muscle tone, thus making the spasms less
noticeable. Alternatively, they may induce sleep or so tranquilize the
patient that normal mental and physical functions are impossible.
8. A healthy, athletic young woman named Valerie Cover was
stricken with multiple sclerosis while in her early twenties. She
consulted several medical specialists and followed all the customary
regimens and prescribed methods for coping with this debilitating disease
over a period of several years. None of these proved availing. Two
years after first experiencing the symptoms of multiple sclerosis her
active, productive life - as an athlete, Navy officer's wife and mother -
was effectively over. The Social Security Administration declared her
totally disabled. To move about her home she had to sit on a skateboard
and push herself around. She spent most of her time in bed or sitting in
a wheelchair.
9. An occasional marijuana smoker in her teens, before her
marriage, she had not smoked it for five years as of February 1986. Then
a neighbor suggested that marijuana just might help Mrs. Cover's multiple
sclerosis, having read that it had helped cancer patient's control their
emesis. Mrs. Cover acceded to the suggestion.
10. Just before smoking the marijuana cigarette produced by her
neighbor, Mrs. Cover had been throwing up and suffering from spasms.
Within five minutes of smoking part of the marijuana cigarette she
stopped vomiting, no longer felt nauseous and noticed that the intensity
of her spasms was significantly reduced. She stood up unaided.
11. Mrs. Cover began smoking marijuana whenever she felt
nauseated. When she did so it controlled her vomiting, stopped the
nausea and increased her
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appetite. It helped ease and control her spasticity. Her limbs were
much easier to control. After three months of smoking marijuana she
could walk unassisted, had regained all of her lost weight, her seizures
became almost nonexistent. She could again care for her children. She
could drive an automobile again. She regained the ability to lead a
normal life.
12. Concerned that her use of this illegal substance might
jeopardize the career of her Navy officer husband, Mrs. Cover stopped
smoking marijuana several times. Each time she did so, after about a
month, she had retrogressed to the point that her multiple sclerosis
again had her confined to bed and wheelchair or skateboard. As of the
Spring of 1987 Mrs. Cover had resumed smoking marijuana regularly on an
"as needed" basis. Her multiple sclerosis symptoms are under excellent
control. She has obtained a full-time job. She still needs a wheelchair
on rare occasions, but generally has full use of her limbs and can walk
around with relative ease.
13. Mrs. Cover's doctor has accepted the effectiveness of
marijuana in her case. He questioned her closely about her use of it,
telling her that it is the most effective drug known in reducing
vomiting. Mrs. Cover and her doctor are now in the process of filing an
Investigational New Drug (IND) application with FDA so that she can
legally obtain the marijuana she needs to lead a reasonably normal life.
14. Martha Hirsch is a young woman in her mid-thirties. She
first exhibited symptoms of multiple sclerosis at age 19 and it was
diagnosed at that time. Her condition has grown progressively worse.
She has been under the care of physicians and hospitalized for treatment.
Many drugs have been prescribed for her by her doctors. At one point in
1983 she listed the drugs that had been
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prescribed for her. There were 17 on the list. None of them has given
her the relief from her multiple sclerosis symptoms that marijuana has.
15. During the early stages in the development of her illness
Ms. Hirsch found that smoking marijuana improved the quality of her life,
keeping her spasms under control. Her balance improved. She seldom
needed to use her cane for support. Her condition lately has
deteriorated. As of May l987 she was experiencing severe, painful
spasms. She had an indwelling catheter in her bladder. She had lost her
locomotive abilities and was wheelchair bound. She could seldom find
marijuana on the illegal market and, when she did, she often could not
afford to purchase it. When she did obtain some, however, and smoked it,
her entire body seemed to relax, her spasms decreased or disappeared, she
slept better and her dizzy spells vanished. The relaxation of her leg
muscles after smoking marijuana has been confirmed by her personal care
attendant's examination of them.
16. The personal care attendant has told Ms. Hirsch that she,
the attendant, treats a number of patients who smoke marijuana for relief
of multiple sclerosis symptoms. In about 1980 another patient told Ms.
Hirsch that he knew many patients who smoke marijuana to relieve their
spasms. Through him she met other patients and found that marijuana was
commonly used by many multiple sclerosis patients. Most of these persons
had told their doctors about their doing so. None of those doctors
advised against the practice and some encouraged it.
17. Among the drugs prescribed by doctors for Ms. Hirsch was
ACTH. This failed to give her any therapeutic benefit or to control her
spasticity. It did produce a number of adverse effects, including severe
nausea and vomiting which, in turn, were partly controlled by rectally
administered anti-emetic
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drugs.
18. Another drug prescribed for her was Lioresal, intended to
reduce her spasms. It was not very effective in doing. But it did cause
Ms. Hirsch to have hallucinations. On two occasions, while using this
drug, Ms. Hirsch "saw" a large fire in her bedroom and called for help.
There was no fire. She stopped using that drug. Ms. Hirsch has
experienced no adverse reactions with marijuana.
19. Ms. Hirsch's doctor has accepted marijuana as beneficial
for her. He agreed to write her a prescription for it, if that would
help her obtain it. She has asked him if he would file an IND
application with the FDA for her. He replied that the paperwork was
"overwhelming". He indicated willingness to put the paper work together.
20. When Greg Paufler was in his early twenties, employed by
Prudential Insurance Company, he began to experience the first symptoms
of multiple sclerosis. His condition worsened as the disease
intensified. He had to be hospitalized. He lost the ability to walk, to
stand. Diagnosed as having multiple sclerosis, a doctor prescribed ACTH
for him, an intensive form of steroid therapy. He lost all control over
his limbs and experienced severe, painful spasms. His arms and legs
became numb.
21. ACTH had no beneficial effects. The doctor continued to
prescribe it many months. ACTH made Paufler ravenously hungry and he
began gaining a great deal of weight. ACTH caused fluid retention and
Paufler became bloated, rapidly gaining weight. His doctor thought
Paufler should continue this steroid therapy, even though it caused the
adverse effects mentioned plus the possibility of sudden heart attack or
death due to respiratory failure. Increased dosages
- 45 -
of this FDA-approved drug caused fluid to press against Paufler's lungs
making it difficult for him to breathe and causing his legs and feet to
become swollen. The steroid therapy caused severe, intense depression
marked by abrupt mood shifts. Throughout, the spasms continued and
Paufler's limbs remained out of control. The doctor insisted that ACTH
was the only therapy likely to be of any help with the multiple
sclerosis, despite its adverse effects. Another, oral, steroid was
eventually substituted.
22. One day Paufler became semi-catatonic while sitting in his
living room at home. He was rushed to the hospital emergency room. He
nearly died. Lab reports indicated, among other things, a nearly total
lack of potassium in his body. He was given massive injections of
potassium in the emergency room and placed on an oral supplement.
Paufler resolved to take no more steroids.
23. From time to time, prior to this point, Paufler had smoked
marijuana socially with visiting friends, seek some relief from his
misery in a temporary "high". He now began smoking marijuana more often.
After some weeks he found that he could stand and then walk a bit. His
doctor dismissed the idea that marijuana could be helpful with multiple
sclerosis, and Paufler, himself, was skeptical at first. He began
discontinuing it for a while, then resuming.
24. Paufler found that when he did not smoke marijuana his
condition worsened, he suffered more intense spasms more frequently.
When he smoked marijuana, his condition would stabilize and then improve;
spasms were more controlled and less severe; he felt better; he regained
control over his limbs and could walk totally unaided. His vision, often
blurred and unfocused, improved. Eventually he began smoking marijuana
on a daily basis. He ventured outdoors. He was soon walking half a
block. His eyesight returned to normal.
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His central field blindness cleared up. He could focus well enough to
read again. One evening he went out with his children and found he could
kick a soccer ball again.
25. Paufler has smoked marijuana regularly since 1980. Since
that time his multiple sclerosis has been well controlled. His doctor
has been astonished at Paufler's recovery. Paufler can now run. He can
stand on one foot with his eyes closed. The contrast with his condition,
several years ago, seems miraculous. Smoking marijuana when Paufler
feels an attack coming on shortens the attack. Paufler's doctor has
looked Paufler in the eye and told him to keep doing whatever it is he's
doing because it works. Paufler and his doctor are exploring the
possibility of obtaining a compassionate IND to provide legal access to
marijuana for Paufler.
26. Paufler learned in about 1980 of the success of one Sam
Diana, a multiple sclerosis patient, in asserting the defense of "medical
necessity" in court when charged with using or possessing marijuana. He
learned that doctors, researchers and other multiple sclerosis patients
had supported Diana's position in the court proceeding.
27. Irwin Rosenfeld has been diagnosed as having Pseudo Pseudo
Hypoparathyroidism. This uncommon disease causes bone spurs to appear
and grow all over the body. Over the patient's lifetime hundreds of
these spurs can grow, any one of which can become malignant at any time.
The resulting cancer would spread quickly and the patient would die.
28. Even without development of a malignancy, the disease
causes enormous pain. The spurs press upon adjacent body tissue, nerves
and organs. In Rosenfeld's case, he could neither sit still nor lie
down, nor could he walk,
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without experiencing pain. Working in his furniture store in Portsmouth,
Virginia, Mr. Rosenfeld was on his feet moving furniture all day long.
The lifting and walking caused serious problems as muscles and tissues
rubbed over the spurs of bone. He tore muscles and hemorrhaged almost
daily.
29. Rosenfeld's symptoms first appeared about the age of ten.
Various drugs were prescribed for him for pain relief. He was taking
extremely powerful narcotics. By the age of 19 his therapy included 300
mg. of Sopor (a powerful sleeping agent) and very high doses of Dilaudid.
He was found to be allergic to barbiturates. Taking massive doses of
pain control drugs, as prescribed, made it very difficult for Rosenfeld
to function normally. If he took enough of them to control the pain, he
could barely concentrate on his schoolwork. By the time he reached his
early twenties Rosenfeld's monthly drug intake was between 120 to 140
Dilaudid tablets, 30 or more Sopor sleeping pills and dozens of muscle
relaxants.
30. At college in Florida Rosenfeld was introduced to marijuana
by classmates. He experimented with it recreationally. He never
experienced a "high" or "buzz" or "floating sensation" from it. One day
he smoked marijuana while playing chess with a friend. It had been very
difficult for him to sit for more than five or ten minutes at a time
because of tumors in the backs of his legs. Suddenly he realized that,
absorbed in his chess game, and smoking marijuana, he had remained
sitting for over an hour - with no pain. He experimented further and
found that his pain was reduced whenever he smoked marijuana.
31. Rosenfeld told his doctor of his discovery. The doctor
opined that it was possible that the marijuana was relieving the pain.
Something
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certainly was - there was a drastic decrease in Rosenfeld's need for such
drugs as Dilaudid and Demerol and for sleeping pills. The quality of
pain relief which followed his smoking of marijuana was superior to any
he had experienced before. As his dosages of powerful conventional drugs
decreased, Rosenfeld became less withdrawn from the world, more able to
interact and function. So he has continued to the present time.
32. After some time Rosenfeld's doctor accepted the fact that
the marijuana was therapeutically helpful to Rosenfeld and submitted an
IND application to FDA to obtain supplies of it legally for Rosenfeld.
The doctor has insisted, however, that he not be publicly identified.
After some effort the IND application was granted. Rosenfeld is
receiving supplies of marijuana from NIDA. Rosenfeld testified before a
committee of the Virginia legislature in about 1979 in support of
legislation to make marijuana available for therapeutic purposes in that
State.
33. In 1969, at age 19, David Branstetter dove into the shallow
end of a swimming pool and broke his neck. He became a quadriplegic,
losing control over the movement of his arms and legs. After being
hospitalized for 18 months he returned home. Valium was prescribed for
him to reduce the severe spasms associated with his condition. He became
mildly addicted to Valium. Although it helped mask his spasms, it made
Branstetter more withdrawn and less able to take care of himself. He
stopped taking Valium for fear of the consequences of long-term
addiction. His spasms then became uncontrollable, often becoming so bad
they would throw him from his wheelchair.
34. In about 1973 Branstetter began smoking marijuana
recreationally. He discovered that his severe spasms stopped whenever he
smoked marijuana.
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Unlike Valium, which only masked his symptoms and caused him to feel
drunk and out of control, marijuana brought his spasmodic condition under
control without impairing his faculties. When he was smoking marijuana
regularly he was more active, alert and outgoing.
35. Marijuana controlled his spasms so well that Branstetter
could go out with friends and he began to play billiards again. The
longer he smoked marijuana the more he was able to use his arms and
hands. Marijuana also improved his bladder control and bowel movements.
36. At times the illegal marijuana Branstetter was smoking
became very expensive and sometimes was unavailable. During periods when
he did not have marijuana his spasms would return, preventing Branstetter
from living a "normal" life. He would begin to shake uncontrollably, his
body would feel tense, and his muscles would spasm.
37. In 1979 Branstetter was arrested and convicted of
possession of marijuana. He was placed on probation for two years.
During that period he continued smoking marijuana and truthfully reported
this, and the reason for it, to his probation officer whenever asked
about it. No action was taken against Branstetter by the court or
probation authorities because of his continuing use of marijuana, except
once in the wake of his publicly testifying about it before the Missouri
legislature. Then, although adverse action was threatened by the judge,
nothing was actually done.
38. In 1981 Branstetter and a friend, a paraplegic,
participated in a research study testing the therapeutic effects of
synthetic THC on spasticity. Placed on the THC Branstetter found that it
did help control his spasms but appeared to became less effective with
repeated use. Also, unlike marijuana,
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synthetic THC had a powerful mind-altering effect he found annoying.
When the study ended the researcher strongly suggested that Branstetter
continue smoking marijuana to control his spasms.
39. None of Branstetter's doctors have told him to stop smoking
marijuana while several, directly and indirectly, have encouraged him to
continue. Branstetter knows of almost 20 other patients, paraplegics,
quadriplegics and multiple sclerosis sufferers, who smoke marijuana to
control their spasticity.
40. In 1981 a State of Washington Superior Court judge, sitting
without a jury, found Samuel D. Diana not guilty of the charge of
unlawful possession of marijuana. In so doing the judge upheld Diana's
defense of medical necessity. Diana had been a multiple sclerosis
patient since at least 1973. He testified that smoking marijuana
relieved his symptoms of double vision, tremors, unsteady walk, impaired
hearing, tendency to vomit in the mornings and stiffness in the joints of
his hands and legs.
41. Among the witnesses was a physician who had examined
defendant Diana before and after he had used marijuana. This doctor
testified that marijuana had been effective therapeutically for Diana,
that other medication had proven ineffective for Diana and that, while
marijuana may have some detrimental effects, Diana would receive more
benefit than harm from smoking it. The doctor was not aware of any other
drug that would be as effective as marijuana for Mr. Diana. Other
witnesses included three persons afflicted with multiple sclerosis who
testified in detail as to marijuana's beneficial effect on their illness.
42. In acquitting defendant Diana of unlawful possession of
marijuana the trial judge found that the three requirements for the
defense of medical necessity had been established, namely: defendant's
reasonable belief that his
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use of marijuana was necessary to minimize the effects of multiple
sclerosis; the benefits derived from its use are greater than the harm
sought to be prevented by the controlled substances law; and no drug is
as effective as marijuana in minimizing the effects of the disease in the
defendant.
43. Denis Petro, M.D., is a neurologist of broad experience,
ranging from active practice in neurology to teaching the subject in
medical school and employment by FDA as a medical officer reviewing IND's
and NDA's. He has also been employed by pharmaceutical companies and has
served as a consultant to the State of New York. He is well acquainted
with the case histories of three patients who have successfully utilized
marijuana to control severe spasticity when other, FDA-approved drugs
failed to do so. Dr. Petro knows of other cases of patients who, he
has determined, have effectively used marijuana to control their
spasticity. He has heard reports of additional patients with multiple
sclerosis, paraplegia and quadriplegia doing the same. There are reports
published in the literature known to Dr. Petro, over the period at least
1970 - 1986, of clinical tests demonstrating that marijuana and THC are
effective in controlling or reducing spasticity in patients.
44. Large numbers of paraplegic and quadriplegic patients,
particularly in Veterans Hospitals, routinely smoke marijuana to reduce
spasticity. While this mode of treatment is illegal, it is generally
tolerated, if not openly encouraged, by physicians in charge of such
wards who accept this practice as being of benefit to their patients.
There are many spinal cord injury patients in Veterans Hospitals.
45. Dr. Petro sought FDA approval to conduct research with
spasticity patients using marijuana. FDA refused but, for reasons
unknown to him, allowed
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