AUGUSTA, Maine — 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.”