Penn State med school hopes for quick start on cannabis studies

Penn State College of Medicine is hoping to start studying medical marijuana as soon as possible under a 10-year partnership with one of the first companies approved to take part in Pennsylvania’s medical marijuana research program

The company is PA Options for Wellness, a grower, processer and dispenser based in Harrisburg. It is one of the first so-called clinical registrants approved by the Pennsylvania Department of Health to begin clinical trials with an academic partner.

Penn State College of Medicine expects to start preclinical studies immediately. The studies will help the medical school determine the doses and research methods that PA Options will use in clinical trials on human subjects, according to Dr. Kent Vrana, chair of the pharmacology department at the medical school, which is in Derry Township, Dauphin County.

The studies will involve departments from across the school, including pharmacology, pediatrics, anesthesiology and public health science. They will start by using marijuana acquired legally through the federal government.

In four to six months, PA Options will begin dispensing its own medical marijuana to Pennsylvania residents certified to receive the drug. The company’s products will either be used in clinical trials or offered for sale, with some of the proceeds going to help Penn State’s research.

The college itself will not use or sell products made by PA Options.

PA Options is expected to begin clinical trials within the next six months. The trials will be double-blind, placebo-controlled, which is considered the gold standard for scientific testing, according to Vrana.

For two weeks, patients will receive doses of either marijuana or a placebo. Neither the provider nor the patient know which they are getting. The trials will give researchers a better idea of what kinds of marijuana are effective in treating which conditions.

Vrana said PA Options and Penn State College of Medicine will look at all of the 21 medical conditions approved by the state for treatment with medical marijuana. Those conditions include opioid-use disorder, epilepsy, cancer and post-traumatic stress disorder.

The state is currently looking at adding anxiety and Tourette syndrome to the list.

“I am confident not all of those will be treatable by marijuana,” Vrana said. “I want to contribute in some small way to what patients can trust.””

Population health scientists from the college will be helping PA Options create a database to document what researchers find.

“We will help them use the database to determine, for example, that the best product for chronic pain would have high CBD and low THC,” Vrana said.

CBD, or cannabidiol and THC or tetrahydrocannabinol, are two chemicals found in marijuana.

Receiving state approval to begin research proved difficult, as the state’s research program met a number of speed bumps along the way, including a lawsuit challenging the program’s legality and a first wave of registrants that was found to fall short of the state’s standards.

But this month, the state approved an initial group of clinical registrants. In addition to PA Options, they include: Agronomed Biologics LLC, affiliated with Drexel University of Medicine in Philadelphia; and MLH Explorations LLC, affiliated with Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia.

“Pennsylvania is on the forefront of clinical research on medical marijuana,” said Dr. Rachel Levine, Pennsylvania’s secretary of health. “This research is essential to providing physicians with more evidence-based research to make clinical decisions for their patients. It is the cornerstone of our program and the key to our clinically-based, patient-focused program for those suffering with cancer, PTSD and other serious medical conditions.”

The state so far has approved 106,000 Pennsylvania residents to use medical marijuana.