By WILLIAM WEIR, firstname.lastname@example.org
The Hartford Courant
6:15 PM EDT, September 11, 2013
Meeting for the first time since regulations for the medical marijuana program were enacted, the state's six-member Board of Physicians began working out the details of an entirely new system Wednesday.
Without the guidance of the U.S. Federal Drug Administration, the state is on its own when it comes to figuring out certain details governing the use of marijuana as a medication. For instance: How will patients be informed about the possible side effects of marijuana use and whether it has contradictions with other medications? How will the state collect data on those effects?
"There's a lot of stuff to do," said William Rubenstein, commissioner of the of the state Department of Consumer Protection, which oversees the program.
All prescription medications receive approval from the FDA, but because marijuana is not federally approved for medicinal use, there are no FDA-approved studies of its effects.
Rubenstein said there are a number of possibilities for how the state can create a database to track any adverse events patients might experience as a result of marijuana use. Without FDA supervision, Rubenstein said, "we don't have a perfect mimicking of that system." Instead, he said, a system for studying marijuana and reporting its adverse effects on patients needs to be developed internally.
Of the 20 states in the U.S. that have medical marijuana programs, he said, Connecticut is in the best position to collect useful data. That's because of the rigorous testing requirements of all marijuana products and the requirement that each marijuana product be labeled with information about its chemical make-up.
"Because we're requiring testing and labeling and the maintaining of the integrity of the product by packaging, we're in a position to know exactly the product profile," said Rubenstein, who serves as an ex officio member of the board.
Board member Dr. Jonathan Kost, a doctor of anesthesia at Hartford Hospital, suggested that physicians in the state receive special training on the effects of marijuana. He compared it to the training required of doctors before they can prescribe Suboxone, a medicine used to treat drug addiction.
Rubenstein said marijuana should be treated the same as most other medications, instead of putting it in a special category. "Our preference is to tread as lightly on the physicians' judgment as we can," he said.
Dr. Deepak Cyril D'Souza, professor of psychiatry at the Yale School of Medicine, suggested that packages of marijuana come with information gleaned from the use of Marinol — an FDA-approved drug that uses THC, one of the active ingredients of marijuana.
Treating patients with marijuana, D'Souza said, "is not the usual practice for physicians, and I am concerned and uncomfortable about how much physicians know about marijuana."
Rubenstein said physicians are free to consider Marinol's effects when deciding whether to certify a patient for marijuana, but the regulations don't require them to do so.
"The design of the program is that those discussions about the benefits and detriments of marijuana are communicated through the physician and the pharmacist," he said.
Rubenstein said that when assessing applications for marijuana production licenses, one of the criteria will be whether the applicant has any plans to fund scientific research on marijuana and its effects. It's in the self-interest of the marijuana producers to help collect data so that they can improve their products, he said.
He asked the board members to think of what kind of data such studies should focus on and to come back with suggestions when the board meets again next February.
"We want to design a program that adds to the scientific discussion," he said. "We're not in a perfect world, but we're in a system that we hope will get us to that perfect world."
State officials expect to award licenses for marijuana producers and dispensaries near the beginning of 2014. Production facilities and dispensaries would be up and running by spring or early summer.
Copyright © 2014, The Hartford Courant