Read Chapter 20 of Pennsylvania’s Act 16? Probably not–and you’re not alone. Act 16, passed in 2016, is the state’s limited yet labyrinthine law legalizing medical marijuana. Even its more digestible parts can be confusing. For example, liquid, gel, cream, pill and tincture forms of marijuana were decriminalized, but joints and edibles were not. And, medical marijuana was approved for patients suffering from only 17 disorders.
In mid-April, Pennsylvania Health Secretary Dr. Rachel Levine accepted the Medical Marijuana Advisory Board’s recommendations to expand Act 16. Dispensaries are now allowed to sell dry leaf, and marijuana was approved for use in, among other things, opioid withdrawal therapy and to treat neurodegenerative disorders.
The state also opened a second round of applications for the licensure of dispensaries and grows, and for clinical registrants (CRs) and academic clinical research centers (ACRCs). As outlined in Act 16’s Chapter 20, CRs’ get so-called “super licenses” that allow them to operate grows and run up to six dispensaries. Regular licensees can open only three dispensaries. However, CRs have to fund medical marijuana research conducted at a teaching hospital that has an ACRC license. Penn, Drexel, Temple and Thomas Jefferson universities are likely to become ACRCs. May 27 is the deadline for applications.
No other state has ACRCs. “By approving ACRCs, Pennsylvania will be the first state in the nation to conduct medical marijuana research to benefit patients in need,” Levine said in a written statement.
How is this going to work? That’s what Dr. Charles Pollack, director of Thomas Jefferson University’s Lambert Center for the Study of Medicinal Cannabis and Hemp, will discuss on May 16 at Main Line Today’s Healthcare Heroes luncheon and awards ceremony. Here’s a preview.
MLT: Despite recreational research that some folks have done for decades, there aren’t FDA-approved clinical trials showing that marijuana can effectively treat most medical conditions. Why is that?
CP: To do an interventional study on cannabinoids, you have to get DEA and FDA approval. Very few studies get approved and those that do are only allowed to use plant substance from one DEA-approved farm, which is in Mississippi. So even if we did a study in Pennsylvania, we can’t use cannabis from Pennsylvania that is available in our dispensaries.
MLT: With interventional studies, researchers could test how different strains and doses of marijuana, and different forms of ingesting it, impact various diseases. If the CR-ACRC still won’t allow for that, what else could be done?
CP: Observational research would be possible. Say a dispensary has 100 patients with neuropathic pain. If they consent, we can follow those patients through questionnaires and other methods – but we can’t randomize or control what they receive. Observational research is a great way to advance science and will result in some interesting work. But it won’t be rewriting textbooks. However, this is such a data-free zone that even observational studies will have a lot of value.
MLT: What would have to change for interventional medical marijuana research to be done in PA or anywhere in the U.S.?
CP: The DEA would have to reschedule marijuana to a Schedule II or Schedule III drug. That would make research less onerous to set up and execute. At the least, the DEA could approve more research grows so we can have more marijuana to work with.
MLT: Given the lack of data, and that it is federally illegal, many physicians in our area are reluctant to write recommendations for medical marijuana.
CP: That’s a choice they have to make in their own practices. This is not a validated therapy, but with the exception of high concentration THC preparations, there don’t appear to be many safety issues. But if they are looking for clinical trial data and an FDA label, we’re years away from that.
MLT: What happens to medical research if Pennsylvania decriminalizes recreational marijuana?
CP: I think it will be quite some time before that happens. We’ll still have a need for research. But how people will use it would probably change. I image they would self-medicate, as they have for centuries, without getting a physician’s input. The more available it is, the more it’ll be used. I suspect that if people can avoid going to a doctor to get it, they probably will.
Click here for tickets and information about Dr. Charles Pollack and Main Line Today’s Healthcare Heroes event.
