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Major Studies of Drugs and Drug Policy

 

                                   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.
                                 - 35 -

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.
                                 - 36 -

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.

                                 - 37 -

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

                                 - 38 -

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.

                                 - 39 -

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

                                 - 40 -

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

                                 - 41 -

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

                                 - 42 -

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

                                 - 43 -

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

                                 - 44 -

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.

                                 - 46 -

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,

                                 - 47 -

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

                                 - 48 -

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.

                                 - 49 -

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,

                                 - 50 -

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

                                 - 51 -

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

                                 - 52 -

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