ADVERTISEMENT

ALBANY – Less than a year after he opposed the use of medical marijuana, Gov. Andrew M. Cuomo is now asking the U.S. Justice Department for a waiver to permit the state to import limited amounts of marijuana for the treatment of seriously ill children and young adults who suffer from rare seizure disorders.

A mid-August letter to Attorney General Eric H. Holder Jr., followed by another correspondence Friday to the Justice Department’s No. 2 official, seeks federal permission for New York to work with private companies to supply special strains of marijuana that have been found to offer relief for children with the rare forms of epilepsy that can result in hundreds of seizures a day and, in some cases, death.

The letters were obtained by The Buffalo News.

Since Cuomo signed a law in July making New York the 23rd state to legalize medical marijuana, at least three children with the seizure disorders have died, including 9-year-old Anna Conte of Orchard Park, whose mother, Wendy, tirelessly worked the halls of the Capitol with other advocates to get the law passed.

“This is an extremely important issue to us, and it will help many children and young adults,” the acting state health commissioner, Dr. Howard A. Zucker, wrote Friday to Deputy Attorney General James M. Cole.

“As a pediatrician myself, I cannot urge you enough to consider this exception to the present law as we all only want the best for these young patients,” Zucker added.

While Cuomo signed the medical marijuana legislation in July, a host of hurdles – from its many restrictions to developing a system for dispensing to how the crop can be grown in New York – will keep the program from being up and running until January 2016 or later, state officials told Holder in an Aug. 13 letter.

On Friday, the state told Justice Department officials that it is seeking to identify one or more manufacturers now operating out of state to dispense the drug to eligible children and young adults; it said dispensers would have to meet a variety of New York and federal legal standards and be deemed to have “sufficient moral character” to participate.

While it awaits word from Washington, the state Health Department is already trying to determine how to identify eligible patients. Officials, speaking on condition of anonymity, said they did not know how many children or young adults might be eligible under the temporary program.

The News previously has chronicled efforts of parents to obtain marijuana for their children, including moving to Colorado to get access to Charlotte’s Web, a strain available in an oil-based or pill format that does not get patients high but has provided some seizure relief. New York officials are not believed to be looking at that specific strain, which is proprietary to its not-for-profit grower and dispenser in Colorado Springs. Instead, they are seeking a marijuana compound already produced out of state by several manufacturers that is especially strong in cannabidiol, or CBD, which appears to provide relief to some children, but without the psychoactive effects.

Wendy Conte was among those making moves to relocate to Colorado with her daughter to get access to the marijuana strain, which is only available to Colorado residents. She had obtained a Colorado driver’s license and was preparing to move there next year, when her specific crop was grown and processed, but her daughter died a couple of weeks after the New York law was signed in July. Anna’s story, and her parents’ push for the legislation, was considered instrumental in moving Cuomo and some lawmakers from opposition to support, according to sponsors of the bill.

Lawmakers had a provision in the medical marijuana bill to permit the state, on an emergency basis, to provide limited access to the drug by manufacturers who grow and make the specific strain for children with the seizure disorders while the broader program was being developed by Zucker and the Health Department. Cuomo, however, did not go along with that provision in the final bill.

In July, after Anna’s death, Cuomo wrote to state health officials telling them to find ways to expedite access to marijuana for children with “refractory epilepsy” who have not responded to conventional treatments that parents say can often have their own debilitating side effects.

Marijuana is illegal under federal law, and transporting it across state lines, as New York is now seeking to do, would require a waiver from the Justice Department and the Drug Enforcement Administration. None of the states with medical marijuana laws transport marijuana across state lines,, at least openly, New York officials say.

State officials are seeking a “narrow, time-limited” waiver from the federal government that would expire when New York’s broader medical marijuana-dispensing program begins.

That program is highly restrictive. It limits the drug’s dispensing, at least in the beginning, to 10 specific diseases or conditions, including AIDS, cancer, Parkinson’s and certain spinal cord injuries. Unlike all but one other state, it bans the sale of medical marijuana in a smoking form, limiting its distribution to pills, oils, extracts, edibles and vapor-based formats. A total of 20 dispensing sites across the state will be operated by four private companies that will grow and provide the drug to patients who have been preapproved by their physicians and the state Health Department.

Cuomo, at any time, could halt the program on his own if his Health Department or law enforcement advisers raise red flags about its implementation, such as diversion of the drug for recreational instead of medicinal use. Unlike other medications sold in New York, medical marijuana sales will be subject to a 7 percent tax.

In its pitch to the Justice Department, the Cuomo administration said the new medical marijuana law in New York complies with the edicts set down in an August 2013 by Cole to U.S. attorneys nationwide. That memo reiterated that marijuana is illegal and considered dangerous and that the Justice Department will continue to prosecute marijuana-related cases, although its focus would be on a number of specific areas, including preventing its distribution to minors or as ways for criminal operations to make money or drug-related violence.

But the Cole memo, coming with the legalization of the drug in Colorado and the State of Washington, recognized that states can take some steps regarding local law enforcement of marijuana within its borders in some cases so long as they implement “strong and effective regulatory and enforcement system” to address threats to public safety and public health.

The acting health commissioner’s letter to Cole on Friday was sent a day after Holder announced he would be stepping down as attorney general after a successor is confirmed. Cole is among those being discussed as a possible successor.

In the letter last month to Holder, Zucker acknowledged that marijuana is not a cure for the seizure disorders but that there is “objective medical evidence” to show that serious seizure cases can be helped with CBD, the medical marijuana strain.

Officials declined to identify the companies under consideration to import the drug in the temporary program, but advocates have pointed to possible suppliers such as Tilray, owned by Seattle’s Privateer Holdings, with a major growing and distribution center in British Columbia. The company is among the private growers participating in Canada’s medical marijuana-distribution program.

In June, The News reported the state signed a deal with GW Pharmaceuticals, a British company, to develop clinical trials to study the use of a CBD marijuana compound, available in an oil format, on children diagnosed with epilepsy and suffering from seizures, who have not obtained relief from conventional medications. While the clinical trials are one way to more quickly get the drug to eligible children, officials stress that GW Pharmaceuticals would not be the company to supply New York with marijuana if the federal waiver is approved.

If a federal waiver for interstate shipment of the drug is approved, sources say, the timing of its availability to patients in New York would depend upon identifying a source of the drug, which would also need federal approval, and then setting up a temporary dispensing system for eligible patients to obtain it.

Anna, who died in July, had been diagnosed with Dravet syndrome before she turned 1 year old. Her parents tried numerous medical treatments, but the girl continued suffering debilitating – and eventually lethal – seizures.

The day after Anna died, her mother vowed to continue fighting to get New York to speed up access to the drug for children suffering from such conditions.

“This is a travesty,” Wende Conte said in July. “Three children passed away this week in New York. How many more children need to die before something is expedited?”

email: tprecious@buffnews.com