Spotlight: Prof. Victor Novack, at Soroka’s Cannibis Clinical Research Institute
"The global medical community lacks high-quality evidence to justify the widespread use of cannabis-derived medicine," says Professor Victor Novack, Director of the cannabis Clinical Research Institute (CCRI) at Soroka Medical Center in Beersheva. The Institute, working in conjunction with the Medical Cannabis Unit of Israel’s Ministry of Health, is one of only a few Institutes worldwide carrying out clinical research to test the safety and efficacy of cannabis medicine applying evidence-based medicine.
"Patients frequently ask us if their medical condition can be treated with cannabis," says Novack. "Mass media regularly publishes miracle stories on panacea effects of the cannabis, often leading to a confrontation between the general public demanding this treatment and the 'conservative' medical establishment."
Novack is a renowned international expert in clinical trial design. He has come a long way from immigrating to Israel alone in 1990, at the age of 20, after the fall of the Soviet Union. With his trademark determination, he enrolled in Ben-Gurion University's medical school, did his residency in internal medicine at Soroka and served as a doctor in the Israel Defense Forces. In 2005 he received his Ph.D. in epidemiology from Ben-Gurion University.
A year later, Novack was offered a position as medical director in a trial design group at the Harvard Clinical Research Institute. He, his wife and their three young children went to Boston, where Novack led and participated in the design of more than 50 pilot and pivotal studies for regulatory approval. He had the opportunity to work with his wife Lena, a bio-statistician, for such companies as Medtronic, Johnson and Johnson and Boston Scientific.
The Novacks returned to Israel after three years in Boston, but Novack continues as a Harvard lecturer, and he and his wife travel back and forth to work on different projects at Beth Israel Deaconess Medical Center.
In 2009 Novack founded the Soroka Clinical Research Center, and in 2016 he and a team of researchers started a new program in the field of cannabis clinical research.
"Doctors are reluctant to prescribe medical cannabis because of lack of scientific evidence," he says.
According to Novack, Israel is in an advantageous position to carry out this research. In the United States, cannabis is not approved by the Federal Government, making it difficult to run research trials. In Israel, cannabis research is supported by the government. And the pioneering scientist who first isolated, analyzed and synthesized the major psychoactive and non-psychoactive compounds in cannabis was Israeli Professor Raphael Meshulam.
Novack notes that although there is an increase in the use of cannabis-based medical products, this is primarily driven by the subjective feeling of the patients – decreased pain, less nausea and better sleep – on their wellbeing.
"The majority of data are derived from surveys of users," he explains. "These retrospective surveys are usually limited in scope and rarely collect variables beyond basic demographic elements, comorbidities, modes of consumption and overall satisfaction."
He stresses that it is important to separate the good that cannabis can do from the possible detrimental side effects that have not yet been tested.
At the same time, in the wake of the opioid epidemic in the US, there is increased use of medical cannabis for analgesic effect. Although side effects are less severe, some of this can be attributed to discontinuing the use of opioids. "Medical cannabis is still a drug," says Novack, "and must be tested accordingly."
The Cannabis Clinical Research Institute (CCRI) is currently carrying out three clinical trials, with five additional trials in the pipeline. These include testing the effect of medical cannabis on irritable bowel syndrome, fibromyalgia and chronic pain.
In addition, the Institute has published more than 10 studies dealing with safety and efficacy of cannabis-based medicinal products. One such study, recently published in Nature Scientific Reports, found that medical cannabis is a safe option for relieving autism symptoms in children under 18, such as seizures, tics, depression, restlessness and rage.
"If we find that medical cannabis just treats pain, this may be enough," says Novack. "We need to be cautious, do trials and accumulate evidence before we prescribe it as a broad-based disease treatment."
The CCRI aims to serve researchers, medical practitioners, policymakers, the pharmaceutical industry and the worldwide scientific community. Its future goals include organizing quarterly seminars and annual international conferences, launching a publication of the open-access scientific journal dedicated to the clinical use of cannabis-derived products and to establish a state-of-the-art infrastructure to support industry-initiated clinical trials."
In his recent article, "Medical Cannabis: What Physicians Need to Know" published in the European Journal of Internal Medicine, Novack writes, "Our ultimate aim should be to scientifically establish the actual place of medical cannabis-derived products in the modern medical arsenal."
Soroka Medical Center, one of Clalit's network of 14 medical centers, is the only hospital in the Negev and the second largest in Israel. It serves over one million residents, including 400,000 children, and is a leader in advancing community medicine.
Professor Novack has published over 250 papers in peer-reviewed journals.