DHHS releases reasoning behind denial of medical marijuana use for Tourette’s syndrome

The Department of Health and Human Services denied the use of medical marijuana to treat Tourette’s syndrome last month because of a dearth of large-scale studies into its effectiveness and side effects, according to a document provided to the Bangor Daily News on Thursday.

A panel of doctors who advise the department’s Bureau of Licensing and Regulatory Services said in the written decision that they wanted to see the use of marijuana to treat Tourette’s syndrome studied under standards used by the Food and Drug Administration.

Dr. Dustin Sulak, one of the state’s leading medical marijuana proponents who led the failed effort to add Tourette’s syndrome to Maine’s list of ailments legally treatable by medical marijuana, criticized the state’s reasoning. He said Thursday that many of the medications already prescribed to Tourette’s syndrome patients are not approved for that purpose by the FDA and that because of federal laws prohibiting the use of marijuana for any reason, the FDA rarely if ever studies the medical use of cannabis.

The four-doctor Medical Marijuana Advisory Committee is made up of Sheila Pinette, director of the Maine Center for Disease Control; Kevin Flanigan, medical director for the Office of MaineCare Services; Lindsey Tweed, medical director for the Office of Child and Family Services; and Christopher Pezzullo, medical director of population health at the Maine Center for Disease Control.

The panel met to discuss the issue on Dec. 11, 2013, and rendered its written decision two days later. The Bangor Daily News has been requesting the document since late December. Sulak said he also had not seen the document until recently.

“Whereas this application is for the use of marijuana as a medication, all four physicians agreed that the principles used by the Food and Drug Administration to assess applications for new medications should form the basis for decision-making,” reads the document. “The FDA looks closely at both safety and efficacy data before approving or disapproving a medication.”

The panel ruled that studies provided by Sulak in his application were not long enough in duration and didn’t involve enough participants.

“Any treatment for Tourette’s, therefore, must be safe when used on a long-term basis,” reads the panel’s decision. “Furthermore, the safety must be demonstrated for children and adolescents as these are the age groups in which Tourette’s syndrome is most prominent.”

Tourette’s syndrome is a neurological disorder that causes involuntary muscular and verbal tics and outbursts. Sulak, as well as 28-year-old Peter Hasty of Sullivan, who is a Tourette’s syndrome sufferer who testified in favor of using cannabis for the condition, said marijuana is very effective in controlling the tics.

“This denial is what I was expecting,” wrote Sulak in response to questions from the BDN. “The philosophy behind the denial, however, contains many errors.”

Sulak said in addition to federal laws against marijuana use, FDA-quality trials are prohibitively expensive; marijuana is an herb, not a drug, and thus should not be regulated like a pharmaceutical; and that federal law is “full of inherent contradictions” about medical marijuana.

Sulak said this marked the first time that DHHS has been directly petitioned to add an ailment to its medical marijuana list. The other process involves legislative action.

“The decision to treat a patient with an off-label medication or natural herb should be in the hands of the physician, not the DHHS,” wrote Sulak. “The medical board is already in place to ensure the safety of this practice. The DHHS process of adding conditions has been broken since 2009, and now that it is finally functioning, it is using standards that are inappropriate. I cannot see how the denial of this petition is protecting public health in any way. Almost none of the other conditions currently accepted for medical cannabis treatment in Maine would pass ‘FDA standards’ either, yet medical cannabis has helped thousands of patients in this state improve the quality of their lives, avoid more dangerous treatments, get back to work and much more.”

Source

Maine DHHS denies bid to make marijuana legal for Tourette’s

Advocates say they will keep trying for approval after an Ellsworth man’s request to make the syndrome a qualifying condition is rejected with no explanation.

Peter Hasty said if he couldn’t use marijuana to control severe muscular tics caused by Tourette’s syndrome, he would be confined to his home in Ellsworth.

“I would not be able to go out the door,” Hasty said. “It (marijuana) has vastly improved my quality of life.”

Although medical marijuana is legal in Maine, Tourette’s syndrome is not one of the conditions permitted for treatment, so for now Hasty has to obtain marijuana illegally if he wants to use it to control the disease.

The Maine Department of Health and Human Services this week denied a request by Dr. Dustin Sulak to add Tourette’s syndrome to the list of qualifying medical conditions that marijuana use is allowed to treat.

Sulak, who prescribes medical marijuana out of his Falmouth practice, said a denial letter signed by Mary Mayhew, health and human services commissioner, arrived on Christmas Eve without any explanation for the decision.

A panel including four doctors gave a recommendation to Mayhew, after a hearing that Sulak and Hasty testified at in November.

Sulak said no one from the opposing side testified.

DHHS offices were closed on Tuesday, and Mayhew could not be reached for comment.

If Tourette’s syndrome had been added to the list of qualifying conditions, patients would have been able to legally obtain marijuana through a dispensary or a licensed caregiver.

Sulak said that a number of studies point to the effectiveness of marijuana in controlling Tourette’s syndrome, and that traditional medication is often ineffective in treating Tourette’s syndrome.

“Tourette’s syndrome does have human studies showing that (marijuana) helps, and it’s not like there’s other good options,” Sulak said.

Two doctors with the Yale School of Medicine wrote on the New York Times web site that there is some indication marijuana could help those who have Tourette’s syndrome, but research is far from definitive.

“The most comprehensive review to date of the efficacy of cannabinoids in Tourette’s comes from a research group in Britain, the Cochrane Collaboration, that reviewed all the available data.

They found that “the improvements in tic frequency and severity were small and were only detected by some of the outcome measures.”

The group concluded that there is not enough evidence to support the use of cannabinoids in treating tics and obsessive-compulsive behavior in people with Tourette’s syndrome,” wrote Dr. Robert King and Dr. James Leckman for the New York Times.

But Hasty, 28, said marijuana is the only medicine that works for him, and he uses it one to three times per day. Hasty said sometimes he smokes it, but he also uses vaporizers and tinctures.

“It is not a miracle drug, but it allows me to function with no side effects,” Hasty said.

Sulak said his request to the state was the first attempt he knows about to add a qualifying condition through the administrative process rather than legislation.

The state Legislature this year added post-traumatic stress disorder and other conditions to the list of permitted conditions, which include chronic pain and Crohn’s disease.

He said he’s not sure if he’s going to challenge the decision.

Paul McCarrier, a lobbyist with the Medical Marijuana Caregivers of Maine, said the legislative process has been more effective in adding approved medical conditions and relaxing some of the medical marijuana rules, while DHHS is more resistant to change through rule making. McCarrier said if DHHS doesn’t allow it by 2015, the Medical Marijuana Caregivers of Maine will lobby the Legislature to add Tourette’s syndrome to the approved list.

Maine is one of about 20 states with medical marijuana laws allowing use of the drug for certain conditions.

Marijuana legalization advocates hope Maine will vote in the coming years to legalize marijuana for recreational use by adults, something Portland residents voted for in a November referendum.

Portland’s vote had little practical effect as marijuana for recreational use is still illegal according to state law.

Source

Maine DHHS: Marijuana can't be used for Tourette's

Maine public health officials have denied an Ellsworth man's request to use marijuana legally to treat his Tourette's syndrome.

The Maine Department of Health and Human Services this week denied a request by Dr. Dustin Sulak to add Tourette's syndrome to the list of qualifying medical conditions that marijuana use is allowed to treat.

Sulak said a denial letter signed by agency Commissioner Mary Mayhew arrived on Christmas Eve without any explanation for the decision.

Sulak and his patient, Peter Hasty, had testified in November that marijuana helped Hasty's muscular tics caused by Tourette's.

Hasty tells the Portland Press Herald that marijuana allows him to function in society.

Studies that looked at the effectiveness of marijuana use to treat Tourette's are inconclusive.

Source