SafeMinds Comments to FDA on Cannabis & Autism

April 23, 2018

Controlled Substance Staff
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave., Bldg. 51, Rm. 5150
Silver Spring, MD 20993-0002

RE: Docket No. FDA-2018-N-1072 for “International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Cannabis Plant and Resin; Extracts and Tinctures of Cannabis; Delta-9-Tetrahydrocannabinol (THC); Stereoisomers of THC; Cannabidiol; Request for Comments.”

Dear Sirs/Madams:

On behalf of our organization, SafeMinds, we are writing to ask the Food and Drug Administration, on behalf of the U.S. Department of Health and Human Services (HHS), to request that the World Health Organization (WHO), through its Expert Committee on Drug Dependence (ECDD), reconsider its control policies on cannabis and products derived from cannabis. We are advocating for the rescheduling of these products from Schedule 1 to Schedule IV substances as defined by WHO, or for the removal of cannabis and products derived from cannabis from the controlled substance schedule completely. We support this policy change due to the potentially high therapeutic benefits which cannabis in its many forms may hold for people with an autism spectrum disorder. Further, rescheduling cannabis will enhance public health, rather than pose a higher risk to it.

SafeMinds (safeminds.org) is a national 501 (c)3 nonprofit focusing on preventing the development of moderate to severe autism and finding effective treatments for autism. We are a parent-led organization with ongoing interactions with caregivers of people with autism and with scientists and clinicians working to address autism. Autism prevalence is growing, including more severe presentations of the disorder.1,2  While autism is defined as deficits in social communication and restricted interests, nearly all individuals with autism have multiple co-occurring conditions, including problems with sleep, aggression, self-injury, cognitive impairment, seizures, gastrointestinal problems, and hyperactivity.3–6

Many parents of young and adult children with autism, as well as more independent adults with autism themselves, are trying cannabis to address these myriad symptoms and behaviors. They are reporting meaningful improvements.7-9 Scientific research suggests reasons why cannabis may be of therapeutic benefit for autism. Converging lines of evidence from animal models of autism and biological studies of affected individuals suggest alterations in the endocannabinoid system, inflammation, and oxidative stress in many cases of autism.10-17 Phytocannabinoids and their synthetic mimetics may ameliorate these conditions.18-21 Research is showing effectiveness of cannabis compounds in addressing co-occurring conditions like seizures, sleep disorders, and gastrointestinal problems.22-25 Studies are also showing that cannabis does not impair cognitive function,26 and in fact can enhance cognitive ability and social function for those who have deficits in these areas.23, 27-29 Preliminary observational and case studies are reporting that cannabis can reduce aggression and self-injury, two potentially life-threatening behaviors that have few approved medications.22,30,31 Existing medications to address these behaviors frequently have significant side effects which may be worse than any associated with therapeutic cannabis use.32,33

Some parents are finding that whole plant formulations with high CBD but also some THC work best. Their observations suggest that the optimal ratio of CBD to THC depends on the symptom or behavior targeted, and that CBD alone may be less effective depending on the outcome targeted. Their observations may possibly be due to the entourage effect.35435 Thus, it is important that all types of cannabis and cannabinoid substances be reclassified to Schedule IV or are de-classified, so that research and clinical practice can proceed to identify the formulation and presentation that works best for the individual or underlying pathology, which is the goal of personalized and precision medicine.

Parents and adult self-treaters with autism need professional guidance based on evidence and the ability to access the widest variety of cannabis and cannabinoid options. Classifying cannabis and cannabis-derived products as Schedule I has the following negative consequences for persons with autism:

(a) Severely limits research activity in the United States. Researchers are hindered in obtaining Federal/NIH funding and have burdensome, expensive, and restrictive regulations securing cannabis products for studies. Our excellent research institutions are falling behind as the advanced studies are going to other countries.

(b) Prevents qualified U.S. health care professionals from helping their patients with autism integrate cannabis into treatment plans because the Drug Enforcement Administration  (DEA) would suspend their prescribing license.

(c) Prevents parents and adult self-treaters from identifying the formulation which will have the greatest therapeutic benefit and the least side effects for the individual. Finding the right regimen almost always involves iterative adjustments in dosing and formulations. The current Schedule I classification prevents access to the widest variety of options.

The lack of adequate evidence, barriers to health care access, and limitations on treatment access from a Schedule I classification impose greater public health risks than Schedule IV or decontrol options for our community.

We thank the FDA and HHS for considering the interests of the autism community as they prepare a scientific and medical evaluation of cannabis and cannabinoid substances, responsive to the WHO Questionnaire request for these substances, for WHO’s consideration in deciding whether to recommend changes to the international control/decontrol of these substances. In sum, we believe that public health will be served by reclassifying these substances to Schedule IV or removing them from the controlled substances list.

Sincerely,

Sallie Bernard
Board President, SafeMinds

Lisa Wiederlight
Executive Director, SafeMinds

 

References

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