Among the physical conditions that may qualify for medical cannabis, few cover a larger swath of the population than chronic pain. New York recently added chronic pain to the list of qualifying conditions for medical marijuana, but the manner by which the state defines chronic pain remains to be determined, and the public has been invited to comment.
The inclusion of chronic pain as a qualifying condition can make or break the economics for entities seeking to grow, process and sell medical cannabis, as well as the ancillary businesses that support those operations. And for investors and entrepreneurs eager to join the notoriously restrictive New York market, an expansive definition of chronic pain could be a game-changer.
Under New York’s current regulations, patients suffering from chronic pain only qualify for medical cannabis if their pain results from one of the other few and relatively rare qualifying medical conditions; the definition does not represent a distinct or sizable patient population. New York’s five organizations licensed to grow, process and sell medical cannabis have been frustrated by the lack of patient demand. At least one of the registered organizations has sought new ownership, despite significant early stage capitalization. Last year, the New York Department of Health took notice of the lack of patient numbers upon the program’s two-year anniversary and committed to determine, among other things, whether chronic pain should stand on its own as a qualifying condition.
In early December 2016, the New York Department of Health proposed, among multiple other regulatory amendments designed to enhance the state’s medical cannabis program, the following definition of chronic pain: “Any severe debilitating pain that the practitioner determines degrades health and functional capability; where the patient has contraindications, has experienced intolerable side effects, or has experienced failure of one or more previously tried therapeutic options; and where there is documented medical evidence of such pain having lasted three months or more beyond onset, or the practitioner reasonably anticipates such pain to last three months or more beyond onset.”
Brooklyn Bridge at and the Lower Manhattan skyline under a purple sunset
The amendment was slated for publication in the New York State Register on Dec. 21, 2016 and will be open to public comment for 45 days thereafter, until Feb. 4, 2017.
The proposed definition constitutes a vast improvement over the current definition, but it still falls short of meeting patient needs. Dr. Bernard Lee, associate chief medical officer for MJHS Hospice and Palliative Care in New York City, was “relieved” that medical cannabis for chronic pain sufferers has “finally arrived” in New York (a sentiment largely echoed by at least one New York registered organization, Etain Pharmaceuticals). However, he questions why cannabis isn’t a first-line treatment. According to Dr. Lee, “cannabis has a safer profile than opioids and is even safer than over-the-counter medications such as Ibuprofen and Tylenol,” both of which have known dangerous toxicity dosages. Dr. Lee’s criticism of the proposed regulation lies with the initial treatment of pain. Indeed, first-line treatment would lend substantial credibility to cannabis as a treatment for chronic pain, combat opioid abuse and spur patient demand and access.
New York is not the first state to qualify chronic pain with restrictions. For instance, the approved conditions in Arkansas include patients who suffer “intractable pain,” defined as “pain that has not responded to ordinary medications, treatment, or surgical measures for more than six months.” Illinois allows medical cannabis only for post-operative chronic pain. And prior to the expansion of its regulations, the New Mexico Department of Health required patients to obtain a recommendation from at least two treating physicians, effectively precluding sufferers who lacked the time, money or insurance to visit two physicians.
It is increasingly difficult to deny the evidence that medical cannabis — including THC, CBD and the terpenes in the plant — is a valuable pain reliever. PubMed, the electronic database maintained by the United States National Library of Medicine, contains more than 800 articles regarding the efficacy of medical cannabis to treat pain. Certain strains have been developed to target different types of pain, including neuropathic pain, inflammatory pain associated with musculoskeletal injuries and arthritis, and pain associated with depression and other mental-nervous medical conditions.
This image was originally posted to Flickr by Anthony Quintano at http://flickr.com/photos/22882274@N04/16335452951.
Terpenes such as Humulene and Caryophyllene are known to be analgesic and anti-inflammatory and show anti-cancer effects; Linalool is also an anti-inflammatory agent; Pinine is known to ease pain through overall brain health.
For New Yorkers and those seeking to participate in the vast potential of New York’s medical cannabis program, the time to bring this medical evidence to the Department of Health is now. Anyone — patients, caregivers and advocates alike — may submit a comment in response to the proposed regulations during the time frame provided. Comments may address the proposed regulation as a whole, or a portion thereof. And comments may be well-researched and comprehensive or brief. Plainly, the opportunity to provide public comment is a cornerstone of our democratic society, but it means little if we do not act.
Lauren Rudick represents investors and startup organizations in all aspects of business and intellectual property law, specializing in cannabis, media and technology. Her law firm, Hiller, PC (www.hillerpc.com), is a white-shoe boutique firm.
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