Rose Homuth lives with her husband and two children in Friendship, a town in Allegheny County of about 2,000 residents.
Her son Ricky is 40. Brady just turned 26. Neither one has mentally progressed much beyond a toddler.
Their seizures, dozens each day, began shortly after they received their DPT vaccinations. The Homuths always assumed there was a correlation. There wasn’t.
Nearly four decades after Ricky’s seizures began, the two boys were diagnosed with Dravet Syndrome, a rare form of epilepsy.
Once Homuth received the diagnosis, she began advocating for medical marijuana in New York State, believing the drug might alleviate her sons’ suffering.
She was thrilled last July when Governor Andrew Cuomo signed the Compassionate Care Act into law, establishing the state’s medical marijuana program.
But eight months later, Homuth still has concerns.
She’s not alone.
As the state health department gets ready to announce final regulations for the medical marijuana law, some advocates, patients and lawmakers remain worried the draft regulations are too restrictive.
The law will allow five registered organizations to open four dispensaries, for a total of 20 dispensaries across a state with nearly 20 million people spread out over 47,000 square miles.
The draft regulations promulgated by the health department in December have Homuth worried she and her family won’t have a practical way to access the drug because the rules do not allow for medical marijuana to be delivered.
Patients or their caregivers must pick up the drug. This lessens the chance the drug is diverted for unlawful use but also makes it harder for patients who have trouble traveling long distances.
The Homuths live 80 miles south of Buffalo, and traveling is difficult because of their sons’ precarious medical condition.
Homuth is also concerned because the regulations only allow physicians to prescribe the drug. Nurse practitioners, whose practices are more accessible in certain remote parts of the state, cannot.
“We live in a rural area where most people see nurse practitioners,” Homuth said.
Margaret Hart, who has multiple sclerosis, lives in Central Square, about 20 miles north of Syracuse, and has similar concerns.
She doesn’t drive and worries she won’t be able to pick up the drug. If legal medical marijuana is too hard to access, she said, many patients will continue purchasing it illicitly.
“I was relieved when [the law] passed but I was really disappointed in a lot of the limitations,” Hart said.
So was Assemblyman Richard Gottfried, chair of the health committee, and the law’s sponsor in the Assembly. Gottfried submitted close to 90 pages of public comments critiquing the health department’s proposed regulations which, he said, “require extensive revision.”
“They will make the system unjustifiably expensive to comply with, creating an inordinate disadvantage for any but the most heavily-capitalized entities; will create a system that is unjustifiably difficult and burdensome for patients and providers; include many provisions that go beyond what is authorized by the statute; and may prevent the system from operating at all,” Gottfried wrote. “The proposed regulations would unjustifiably deprive seriously ill patients of relief and subject many patients to gratuitous cruelty.”
For example, Gottfried cites a draft regulation that prohibits a patient from taking medical marijuana outside New York State.
“It is gratuitously cruel to say that children with severe epilepsy being treated with medical marijuana can’t take their medicine with them when they visit grandma in New Jersey,” he wrote.
Businesses have their own concerns with the draft regulations.
The state has yet to announce the price for medical marijuana, a crucial piece of information for anyone considering getting into the business of selling the drug.
There is also a concern over the rule that no marijuana in unprocessed whole flower form be available to patients.
Everyone is concerned it remains a federal crime to grow, possess and distribute marijuana. While the Obama administration has allowed state programs to operate unfettered, a new administration’s justice department may take a different approach.
This afternoon, Senator Kirsten Gillibrand will join Senator Cory Booker of New Jersey and Senator Rand Paul of Kentucky to announce new legislation that would protect from federal prosecution patients, doctors and businesses in states that allow medical marijuana. It is not clear if the bill could pass.
Governor Andrew Cuomo has said New York’s medical marijuana program will be up and running by January and his health commissioner repeated that target last month.
But if the state doesn’t release its final regulations and begin the application process within the next few weeks, it is hard to see how the plant will be available to patients by January.
Companies interested in growing will likely need 45 to 60 days to complete their applications, which are expected to be thousands of pages long.
The state, if it intends to look at these organizations with even a modicum of rigor, will likely need a couple of months to review the applications.
Then, the licensed organizations will need to buy or construct a grow facility in a local jurisdiction, which may require a new set of permits.
The draft regulations require each registered organization to have at least a one-year supply on hand of any offered brand. That won’t be easy to grow quickly.
“There is huge demand on high C.B.D. [Cannabidiol] strains,” said Meg Sanders, chief executive of a network of dispensaries called Mindful. “Those strains take longer to finish and they don’t yield as much.”
In an email, a health department spokesperson said “D.O.H. anticipates filing a notice of final adoption in the near future.”
Acting state health commissioner Dr. Howard Zucker said last month he is not inclined to expand the program before it gets off the ground.
“I think it is our responsibility to make sure this is a safe program,” Zucker said at a state Public Health and Health Planning Council meeting. “I know it’s very restrictive and I know many people are asking about other things we can add, but let’s get it up and rolling and see where we are.”
It is certainly easier to start small and then expand than to try and pull back should a piece of the program run off course.
The take-it-slow approach has certain advantages, not least of which is that it is in keeping with Cuomo’s preference for a tightly controlled program. The governor, who is wary of being characterized as too liberal, has boasted that this law will be the most tightly regulated program in the country.
That means, however, that the state and the registered organizations awarded a license have little room for error if the program is to have a successful launch by 2016, as Zucker and Cuomo hope.
Because there are only five registered organizations, operating fours dispensaries each, the consequences of one failing, or getting off to a slow start could impact an entire region of New York.
“I know we’re heading in the right direction,” Homuth said, “But it’s scary right now. With as many people wanting to get hold of medical marijuana, I’m afraid it will fail. I hope it doesn’t but how can it work when your hands are tied by so many regulations?”
