Israel has recently been in the news after the government issued its long-delayed final approval of medical cannabis exports. Still, Israel’s most important cannabis export will arguably continue to be clinical data. While research in the United States remains strangled in a Schedule 1 chokehold, Israelis are diligently engaged in cannabis R&D, fueled by the country’s relatively supportive regulatory climate, well-established research infrastructure, and hyperactive entrepreneurial spirit.
Tikun Olam, Israel’s veteran medical cannabis company, maintains a robust medical research program which draws from its detailed database of tens of thousands of patients, and extensive clinical research collaborations with academic and medical partners. I recently spoke with Lihi Bar-Lev Schleider, director of Tikun Olam’s research department, about studies the company has been involved in with a focus on older adults.
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In our conversation, Schleider described the results of a prospective study on the safety and efficacy of medical cannabis in the elderly, conducted in collaboration with Soroka Medical Center, and recently published in the European Journal of Internal Medicine. The study evaluated the response to medical cannabis of patients over 65 with conditions including cancer and its associated pain and treatment side-effects, neuropathic pain and Parkinson’s disease, among others.
Efficacy, Safety and Harm Reduction
Statistical analyses revealed that after six months of treatment with cannabis, patients reported significant reduction in pain levels and improvement in quality of life and a perception that the treatment was effective for their condition. The most common adverse effects were dizziness and dry mouth; these were generally mild and in most cases correctable by adjusting the dosage or strain. While dizziness can increase the risk of falls, the number of actual reported falls was significantly lower after the treatment compared to before it.
Particularly notable to Schleider was the reduction in opioid use reported by patients after starting medical cannabis.
What’s absurd, she notes, is that in some places, opioid use is a disqualifying condition for medical cannabis use. On the contrary, she stresses, these are exactly the patients who should be given cannabis.
Improving Dementia Behavior
Patients are now being recruited for another collaborative trial in the geriatric department at an Israeli hospital, investigating the use of cannabis for treating dementia patients with severe behavior disorders.
Dr. Vered Hermush, Director of the Geriatric Wing at Laniado Hospital and the principal investigator of the trial, explains that behavior disorders in dementia patients are both common and extremely difficult to treat. Anti-psychotic drugs are not especially effective and can have severe side effects, and patients also develop a tolerance to them. After observing the positive effects of cannabis on the behavior of patients who received it for other conditions, Dr. Hermush approached Tikun Olam to initiate a study.
Extreme and sometimes violent behavior in individuals with dementia can make life miserable for themselves and their families, Dr. Hermush notes. But while the assumption is that cannabis would have a sedating effect on these patients, it actually seems to improve mental functioning as well. Dr. Hermush has seen patients who were completely non-communicative begin to engage with their family members after cannabis treatments.
According to Dr. Hermush, this study is intended to establish with hard data what has until now been reported anecdotally. Ultimately, it has the potential to introduce an alternative treatment approach to drugs that may not be helpful and could cause damage.
Improving appetite in dialysis patients
Another collaborative trial with Tikun Olam which is now recruiting patients is investigating cannabis use among dialysis patients who are suffering from poor nutrition.
Cannabis is already indicated as an appetite stimulant for cancer and AIDs patients. But poor appetite is also common in dialysis patients, and standard treatment approaches are not generally effective for this population. Tikun Olam is working with a leading nephrologist at a major Israeli hospital to investigate whether medical cannabis use can result in increased calorie consumption, weight gain or prevention of weight loss among dialysis patients, with attendant health benefits.
Jumping through hoops
Even in Israel, conducting research with cannabis entails bureaucratic obstacles. Schleider explains that the approval process for a cannabis research proposal involves numerous committees and can take up to several years. And still, this hasn’t prevented Tikun Olam from pursuing studies on topics ranging from cannabis for migraines and autism to irritable bowel disease, as well as a new study which is producing for the first time actual evidence-based data on interactions between cannabis and other drugs. Precisely for issues as pressing as opioid reduction, the data from each new study can potentially tip the scales towards changes in legislation and public health policy.