Source: HerbalGram

By: Lindsay Stafford Mader

2012

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

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.

References

1. Stafford L. The state of clinical cannabis research in the United States. HerbalGram. 2010;85:64-68.

2. Brinn D. A growth sector. Jerusalem Post. March 19, 2009. Available at: www.maps.org/media/view/a_growth_sector/. Accessed December 17, 2012.

3. Wachtel B. Medicinal cannabis in Israel. September 2011 [unpublished].

4. Wisneski L, Anderson L. The Scientific Basis of Integrative Medicine, 2nd ed. CRC Press; Boca Raton, Florida. 2009.

5. Single Convention on Narcotic Drugs, 1961. The United Nations. Final act of the United Nations conference for the adoption of a Single Convention, as amended by the 1972 Protocol amending the Single Convention on Narcotic Drugs, 1961. Available at: www.unodc.org/pdf/convention_1961_en.pdf. Accessed December 17, 2012.

6. Siegel-Itzkovich J. More MDs to get licenses to prescribe medical marijuana. Jerusalem Post. September 6, 2010. Available at: www.jpost.com/HealthAndSci-Tech/Health/Article.aspx?id=187221. Accessed November 27, 2012.

7. Mechoulam R. Israel: legal aspects of marijuana use, medical use. October 20, 2008. International Association for Cannabinoid Medicines. Available at: http://cannabis-med.org/index.php?tpl=page&id=45&lng=en&sid=1b35fdd1438521c70b7a145c6cf33ffb. Accessed December 17, 2012.

8. Ryan JD. Patients to pay for medical marijuana. Jerusalem Post. January 19, 2010. Available at: www.jpost.com/HealthAndSci-Tech/Health/Article.aspx?id=166124. Accessed November 27, 2012.

9. Wachtel B. Medical cannabis in Israel: review, lessons and recommendations for other countries. Presentation at Cannafest in Prague, Czech Republic. November 10, 2012 [unpublished].

10. Peleg M. Large-scale cannabis training: 3 years of lessons learned in Israel. Presentation at Cannafest in Prague, Czech Republic. October 28, 2012 [unpublished].

11. Russo E. Cannabis treatments in obstetrics and gynecology: a historical review. J Cannabis Ther. 2002;(3/4):5-34.

12. Harkov L. Israel is world leader in medical marijuana use. Jerusalem Post. March 6, 2012. Available at: www.jpost.com/Health/Article.aspx?id=260692. Accessed November 27, 2012.

13. Kershner I. Studying marijuana and its loftier purpose. New York Times. January 1, 2013. Available at: www.nytimes.com/2013/01/02/world/middleeast/new-insights-on-marijuana-in-israel-where-its-illegal.html?_r=0. Accessed January 4, 2012.

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