Issue:
97
Page: 38-45
The Quiet Giant: Israel’s Discreet and Successful Medicinal Cannabis Program
by Lindsay Stafford Mader
HerbalGram.
2013; American Botanical Council
Despite its status as one of the
world's leading nations for medical research and innovation, the United States
has a remarkably restrictive system in place to regulate medicinal cannabis research. Even when the US Food and Drug Administration (FDA) approves
medicinal cannabis studies, the researcher or institution must then obtain approval from the Public Health Service (PHS), as well as procure cannabis
material from the National Institute on Drug Abuse (NIDA), which has a monopoly
on the supply of cannabis that can be used for research throughout the entire country.1 Cannabis (Cannabis
spp. Cannabaceae) is the only scheduled substance for which PHS approval is
required, and those wishing to study the plant often have been rejected by the agency — effectively quelling this important area of science. An increasing
number of US states have taken matters into their own hands by legalizing medicinal cannabis for residents with certain health conditions. But the
federal government continues to raid and shut down state-based medicinal cannabis operations, even sending some of these business owners to prison.
Although the US situation is largely based on the discrepancy between state and
federal law, Americans and citizens of other countries that ban medicinal cannabis could learn just how successfully, compassionately — and
non-controversially — such a program can be handled by looking at the unique
national medicinal cannabis program in Israel.
Path to Medicinal Access
The Israeli government always has classified cannabis as dangerous and illegal, and it remains a crime to use the
herb recreationally and without a license from an approved physician. Unlike US state-based medicinal cannabis initiatives, the nationwide program in Israel
has won growing support from government officials, inciting relatively little
controversy among Israeli citizens, public officials, and religious leaders.2
In 1995, the Israeli Parliament Drug
Committee formed a subcommittee to examine the legal status of cannabis, which
recommended that the government continue to categorize cannabis as illegal, but
also that it allow and regulate access to medicinal cannabis for severely sick
patients.2,3
“The second recommendation was of
course extremely positive and important,” said Boaz Wachtel, a medicinal cannabis activist in Israel who served as one of two public representatives on
the committee (email, November 29, 2012).3 “For the first time a
Parliament-nominated committee acknowledged the medical use of cannabis and
created an opening to advance the subject.”
Wachtel noted other important factors behind the committee’s recommendations, including the
US Food and Drug Administration’s 1985 approval of the synthetic THC-containing
drug Marinol®, as well as input from Raphael Mechoulam, MD, who also
served on the committee. Dr. Mechoulam, a Bulgarian-born Israeli scientist,
isolated tetrahydrocannabinol (THC) in 1964.2 In 1992, Dr. Mechoulam
and colleagues Lumír Ondřej Hanuš and William Anthony Devane isolated and
described anandamide, a endogenous cannabinoid neurotransmitter in the human
brain.4
“I assume that the successful cannabis research in Israel has had some impact on the decision by the Ministry
of Health to proceed with a carefully regulated medical marijuana program,”
said Dr. Mechoulam (email, December 6, 2012). “The committee I chaired in 1995
consisted mostly of government officials. Their overall attitude was quite
liberal. We tried to minimize criminalization and to find ways to legalize
medical use. Our report was never discussed or approved, but I am under the
impression that it affected the attitude of the police and the Attorney
General.”
Several societal and political
forces also were at play before and during the Israeli government’s cautious
but genuine interest in medicinal cannabis, said Rick Doblin, PhD, executive
director of the California-based Multidisciplinary Association for Psychedelic
Studies (MAPS), who has collaborated with the Israelis on medicinal cannabis
and MDMA (also known as ecstasy) research. For one, Israel’s most important
ally, the United States, is opposed to medicinal cannabis and Israel did not
want to compromise that relationship. On the other hand, there is the deep,
fundamental Jewish principle to ease suffering, which many saw cannabis as
doing.
“Also the fact that Mechoulam is
from Israel and they had this tradition in being world leaders in cannabinoid
research, they put their toe in the water,” said Dr. Doblin (oral communication,
December 4, 2012). “They did see that there is an awful lot of suffering that
marijuana can help reduce at a very low cost.”
When considering a national program,
the Israeli Ministry of Health (MOH) consulted with Dr. Doblin and MAPS and a
few additional medicinal cannabis groups on programs in other countries. Israel
strived to comply with international drug treaties, particularly the 1961
United Nations Single Convention on Narcotics, which “aims to combat drug abuse
by coordinated international action” and limits narcotic drugs to medical and
scientific use.5 Among several provisions on medical usage in the
44-page document, the Single Convention calls for limiting “the cultivation,
production, manufacture, and use of drugs to an adequate amount required for
medical and scientific purposes, to ensure their availability for such purposes
and to prevent illicit cultivation, production and manufacture of, and illicit
trafficking in and use of, drugs.” (Interestingly, this is the very same treaty
that the United States has used to argue in favor of its stifling monopoly on
cannabis research supply.1)
“The Israelis have been quite aware of the obligations of the Single Convention and the different ways it has been
interpreted around the world,” said Dr. Doblin. “They could see that even though the US wasn’t willing to go that far on a federal basis, that there were
states that were going this far and also other countries, like the Netherlands
and Canada. That helped them to feel more comfortable because what we were able
to show them is that the International Narcotics Control Board — which
evaluates compliance with international treaties, particularly the Single
Convention — had never censured any of the countries or spoke out against
them.”
Despite Israel’s initial concerns for compromising its strong relationship with the United States, Dr. Doblin
noted that he has seen no evidence of such backlash. “None at all,” he said.
To satisfy an important Single Convention requirement for one specific agency to oversee certain functions
related to the medicinal use of prohibited drugs, Israel appointed its MOH to lead the country’s medicinal
cannabis program.3 Still, implementation was slow and measured. In
1996, Wachtel met with an MOH official to discuss the implementation of the
cannabis subcommittee’s recommendations, and he also submitted a request to
supply an HIV patient with medicinal cannabis.
“He said, ‘You have opened an
important but controversial door — find a way to implement the program that would
not cost the Ministry any money,’” said Wachtel, recounting the official’s
response. “Supplies were a problem. The police [were] not willing to provide
the cannabis confiscated from the black market. The patients need a few strains
of standardized, organic product that will not damage their weakened immune
systems. The MOH did not have an answer at this point.”
About two years later, the MOH
permitted several patients to grow a few cannabis plants in their own homes,
but most became too sick to attend to the plants and an accusation arose that
the HIV patient was selling cannabis to minors.3 As a result of
these initial roadblocks, the MOH did not issue any additional medicinal
cannabis prescriptions for two years. It considered importing cannabis, but due
to concerns regarding cost and Single Convention limitations, officials
eventually decided to allow a young Crohn’s Disease patient to grow cannabis
for himself and the other six patients who were licensed at the time. He also
became too sick to grow. With the MOH still unsure of exactly how to implement
large-scale production of medicinal cannabis, the program experienced several
years of little action.
“The breakthrough occurred when the
MOH appointed Dr. Baruch as the new Deputy Director specifically to deal [with]
the issue of medical cannabis,” said Wachtel. “The final decision to approve
requests from patients and move the program forward was in his hands.”
Modern Evolution of Israel’s Medicinal Cannabis Program
Israel’s medicinal cannabis program
has evolved ever so slowly with each passing year. During its first decade, the
government issued only 62 prescriptions. Now about 9,000 medicinal cannabis
prescriptions are currently active, said Yehuda Baruch, MD, the former head of
the program (email, December 4-16, 2012).
“The vision [has been] to help those
in need when there is no other viable option [at] an affordable price and with
as little bureaucracy as can be,” said Dr. Baruch, who is also a psychiatrist
and director of the Abarbanel Mental Health Center in Bat Yam. The widespread
relief medicinal cannabis can provide to many patients does not come without
the paradoxical negative, from Dr. Baruch’s perspective, that the same patients
also achieve a recreational high. “The increasing number [of permits] is both a
point of concern because the main source today for recreational use is
medical cannabis, but also a blessing because it is one more medicine in the
pharmacopeia that can be used when all else has failed, and since it works by a
different mechanism of action, it may prove successful.”
Dr. Baruch led Israel’s medicinal
cannabis program for a decade, from 2002 until December 2012. (Although his
replacement has not been publicly announced, sources for this article have
indicated it is Yuval Lanshaft, a former high-ranking Internal Security
officer.) For several years Dr. Baruch was the only physician in the entire
country allowed to issue patient licenses, and he also was in charge of
organizing and leading the program along with the Ministry of Agriculture,
Homeland Security, and the customs office.
“I personally lectured in every
academic or medical meeting that was possible, even if it was a very small
one,” said Dr. Baruch, “and gave my private phone number and an invitation to
call on anything. I also worked closely with relevant politicians and discussed
the subject in the Israeli parliament various times. All in all, a lot of leg
work.”
In 2010, the MOH decided to allow
additional physicians in five hospitals to provide medicinal cannabis licenses
to patients, lifting the heavy responsibility from Dr. Baruch and enabling
somewhat faster and easier patient access to the herb.6 Currently,
nine physicians are permitted to share this load. Dr. Baruch noted that while
all senior physicians in the country can request
a license for any number of their patients who might benefit from medicinal
cannabis, only these nine MOH-appointed physicians are allowed to approve and issue permits. Because cannabis can be prescribed only as a “last
resort” medicine, patients usually are told about it while they are in
emergency rooms and oncology and pain wards, and the requesting physician must
state that all drug treatment used thus far has been unsuccessful.7
While the increase to nine
physicians was an improvement, Dr. Doblin noted that having this few
prescribing doctors might impose burdensome limits on a nation of patients
(news reports have referenced a MOH study that found 40,000 Israelis could
benefit from cannabis8).
“I think that right now [Israel’s
program] is a tremendous success,” said Dr. Doblin. “It’s too limited, I would
say, because there are a lot more people that could benefit. The Ministry is
keeping a fairly solid control over the growth of the program. But in the
Israeli context, I think that prevented a backlash, so maybe that was the right
approach at the time. Still, it’s not the best approach since patients are not
currently permitted access for [post-traumatic stress disorder] and other
conditions.”
Initially, patients could obtain medicinal
cannabis licenses only for asthma, and years later additional conditions were
accepted, including AIDS wasting syndrome, vomiting and pain associated with
chemotherapy for cancer, and all other applications were considered on a
case-by-case basis, said Dr. Baruch. Now patients with the following conditions
are considered for prescriptions:
Chronic
pain due to a proven organic etiology
- Orphan
diseases (i.e., diseases and
conditions that affect only a small percentage of the population and for which few,
if any, pharmaceutical drugs are developed)
- HIV
patients with significant loss of body weight or a CD4 cell count below 400
- Inflammatory
bowel disease (but not Irritable
Bowel Syndrome)
- Multiple sclerosis
- Parkinson’s
disease
- Malignant
cancerous tumor in various stages.9
As of 2011, most patients using
cannabis had chronic pain, closely followed by cancer-related conditions.9
For many years, the MOH struggled to
achieve a cultivation and distribution system that satisfied government
officials as well as patients. In 2007, Dr. Baruch licensed one individual in
Israel to grow about 50 cannabis plants to provide material to patients
free-of-charge.3 The man, Tsachi Cohen, did so in his parents’ house
in northern Israel. The garden was attended and cared for by his mother, a
former biology teacher. Eventually, Dr. Baruch licensed several other growers,
none of whom were allowed to sell the cannabis for a profit. Many sources
interviewed for this article indicated that the initial nonprofit model
contributed to the program’s success and acceptance.
“The first feel that the public got
was that these are people acting in the public interest and not for personal
gain,” said Dr. Doblin.
This small-scale operation by the
Cohen family eventually grew into the country’s first, and currently the
largest, production center, called Tikun Olam (the Hebrew term based on the
Jewish principle that all people should try to repair the broken fabric of the
universe through acts of kindness, compassion, healing, and justice).
Ultimately, all of the growers’ nonprofit model — which relied mainly on
donations — could not be sustained due to the increasing number of licensed
patients and the intensive and expensive process required for cultivating
high-quality cannabis on a large scale. So the government began requiring
licensed growers to charge patients a monthly fee of 360 Israeli New Sheqels
(approximately $100 USD) for up to 100 grams per month. The initially
prescribed monthly dosage is 20 grams, with 42 grams being the average amount,
and every patient is charged the same fee every month, regardless of how much
cannabis they receive.8 The price is relatively inexpensive when
compared to cannabis in other countries, and several large Israeli medical
insurance companies, the Holocaust Survivors fund, and the Ministry of Defense
(for some patients with post-traumatic stress disorder) partially cover the
cost of medicinal cannabis.
“The most important [milestone] was
the transition from nonprofit to for-profit,” said Dr. Doblin, whose MAPS
organization had donated about $85,000 to support the nonprofit facilities.
“You could say it was a transition from a non-sustainable model to a
sustainable model. Another point that makes Israel so astonishingly successful
as a model is that some of their health insurance companies cover marijuana.
That’s the kind of information that really needs to get out in America. That
for whatever reason, we have insurance companies deciding it is a smart
investment to cover medical marijuana. Israel is the only place I know of where
that happens.”
There are currently seven licensed
growing centers that distribute medicinal cannabis on-site, through home
deliveries, in small dispensaries in a limited number of urban locations and
hospitals, or at one of the larger distribution centers.9 The
central distribution center, named MECHKAR, a Hebrew acronym meaning research,
represents an important aspect of the Israeli program. At MECHKAR, patients not
only obtain cannabis, but also are welcomed to be trained and counseled on
topics such as which strains and dosage forms might be best for their
particular condition and lifestyle; levels and location of pain and any other
health conditions; and emotional or religious concerns and experiences.10
Staff also closely supervise patients throughout the first few months with
feedback forms and meetings in order to optimize dosages, reduce any unwanted
side effects, and discuss potential drug interactions.
“We may be the only government on
earth right now where patients are sent to use marijuana who have absolutely no
desire to use it,” said Mimi Peleg, the director of large-scale training at
MECHKAR (email, November 29, 2012). “They do have a strong desire to stop
suffering, of course. My first job as a trainer is to relax them enough to even
consider the idea that it is okay to use this medication. Working with patients
who receive cannabis has taught me that the quality of education that is shared
at the beginning of the treatment is an important factor in leading to an optimal
control of symptoms.”
From time to time, the MOH discusses
the possibility of importing medicinal cannabis from the Netherlands, and it is
currently in the process of setting up a large, multi-institutional ministerial
Medicinal Cannabis Agency to handle all aspects of medicinal cannabis
production, dispensing, testing, and licensing.3 The government also
has been discussing pharmacy distribution to begin sometime in 2013, but it is
unclear if this initiative will actually be implemented on time.6 If
this step is taken, it is anticipated that the large government agency will
purchase all cannabis material from growers, store it in government-controlled
warehouses, and then distribute it though pharmacies.9
“As a cannabis trainer, this shift
will impact my current role,” said Peleg. “By and large, I think it is a
positive move in the right direction. I [still] see the need for some
distribution centers where patients can go for further training and strain
adjustments. Treating people with cannabis requires much more than just
purchasing medicine at a pharmacy.”10
Cannabis is available to patients in
a variety of forms such as baked goods, ready-made cigarettes, oils, and
tinctures.10 Patients with a medicinal cannabis license also are
allowed to ingest cannabis through Volcano® Vaporizers, a device
typically costing $500-600 USD retail that heats the cannabis without burning
it so that no smoke and reduced amounts of combustion byproducts are produced.
Several Israeli health insurance companies and patient care groups also cover
some of the price of purchasing or renting a Volcano, which has been licensed
by the MOH and approved by the Israel Standards Institute, and several devices
donated by Volcano Medic in Israel are available in four public hospitals for
patients who cannot afford their own.
“All this has been a huge
cooperative effort,” said Peleg. “They put four Volcanos in major hospitals and
patients with licenses can request private mouth pieces and balloons or take
their own Volcanos in. I did when I was healing from cancer and thereby avoided
needing morphine in recovery! It was wonderful to have the choice.”
For all the bold measures taken with
medicinal cannabis in Israel, it remains a largely non-controversial situation.
The diverse range of patients helped by the herb includes former soldiers, police officers, settlers, Arab Israelis, and elderly Holocaust survivors. Dr. Doblin mentioned that religious leaders have declared cannabis kosher, and
Peleg noted a religious, political, gender, and age diversity among the
hundreds of patients she has trained over the years.
“A month after her initial training,
Hanna* came back in with [her husband] Hiem*, and as is
often the case, I barely recognized them,” said Peleg of a Holocaust survivor
whom she trained to use medicinal cannabis for pain.10 “There was an
undeniable intimacy between them that had been absent in their prior visit —
clearly they had been doing some communicating. Instead of being happy, Hanna
was livid and for all the right reasons. She wanted to know who to blame for
the fact that she hadn’t been given this medication years ago if it had been
known and available. Again, who could blame her? Her pain was gone, she had an
appetite, she was communicating with loved ones — cannabis was doing its job.
Israel is a very small country. We are only 8 million citizens. Word spreads
fast and the pressure on the system is extremely high due to stories like
Hanna’s that highlight efficacy.”
Cannabis activist Wachtel also noted
the late-1980s discovery of ancient cannabis material in a burial tomb in Israel, which researchers postulated was likely given to a 14-year-old girl, also found in the tomb, to “facilitate the birth process” of her unborn child.11 “Cannabis,” said Wachtel, “is therefore viewed here as an indigenous medicinal plant, one that was out of use for a while but is now back in its natural place
in the modern pharmacopoeia to alleviate a great number of medical symptoms.”
Even with relatively little controversy, Israeli police allege that cannabis fields attract criminals who
steal plants to sell on the black market.12 But Wachtel noted that very little diversion is taking place because the growing operations are
typically secured by cameras and armed guards.
Supporters of medicinal cannabis in Israel also see areas where the program can be improved upon. Peleg noted the need for a national strain bank, retrospective assessments of medicines used concurrently with cannabis, a broadened list of diseases, and a more comprehensive training program for medical professionals and patients.
Additionally, the process of requesting cannabis and obtaining a physician recommendation and official patient license, while sometimes quick, also can be very lengthy.13
“The system is bursting at the seams,” said Peleg. “If 10 more people worked in the MOH just on cannabis, we couldn’t do all the work that needs to be done.”
Dr. Doblin stressed the need for
Israel to produce official medical-grade cannabis supported by Good Manufacturing Practices, thorough documentation, and product standardizations. Even though several Israeli health insurance companies already cover cannabis
without it having been through the formal drug-approval process, he noted the possibility of importing medical-grade cannabis from Israel into the United
States to support scientific research. (Dr. Doblin’s FDA-approved research that seeks to develop the plant into an approved prescription medicine has been
rejected by the PHS/NIDA process.1)
That Israel’s government is
generally far more accepting of the herb’s potential as a medicine has enabled
a much freer cannabis research community. Dr. Mechoulam, for example, has been
obtaining hashish (a preparation made from compressed THC-rich resinous
material) from the Israeli police for more than 40 years, with MOH
approval.
“Research in Israel is highly
respected and neither the police nor the Ministry of Health have ever raised any major problems,” said Dr. Mechoulam. “They have been, and still are, very helpful. This is true for both basic and clinical research.”
“The benefit of a program like
Israel’s is that the government takes a role in ensuring quality and safety of
the product, and supports research to further the understanding of the plant’s
medical benefits, said Amanda Reiman, PhD, California policy manager for the
Drug Policy Alliance (email, December 1, 2012). “In the US, the government has
actively prevented research from taking place, and has threatened
municipalities that attempt to regulate the quality and safety of the product
with criminal prosecution.”
* Names have been changed to protect patients’ privacy.
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