July 14, 2014 | Posted By Bruce D. White, DO, JD

On the very last day of the 2014 legislative session, the New York Senate passed “The Compassionate Care Act” (S.1682-A, Savino) approving the legalization of medical marijuana.  The Assembly had previously passed a companion bill (A.6357-A, Gottfried). The Senate bill has been sent to Governor Cuomo for his signature. The governor endorsed the bill in the legislature, but as of July 4, 2014, has yet to sign it.

New York medical marijuana proponents have been advocating for the availability of cannabis for several years. Neighboring states Connecticut, New Jersey, and Vermont, and 18 other states and the District of Columbia currently allow medical marijuana. However, last minute compromise changes to the New York law will severely restrict access to medical cannabis. In fact, the limitations are so rigid that some might say the bill is a hallow shell, a sham, one designed to appear to allow medical marijuana yet really not. Regardless of how one feels about medical cannabis, to hype the public into believing that marijuana will be available for medical purposes and then establishing barriers to its accessibility that is a fraud. It would be unconscionable to raise the hopes of distressed patients, many suffering with chronic and painful conditions, only to see those hopes dashed.

What are a few of these barriers in the compromise bill? First, the raw plant will not be available so that a patient may smoke the plant as one might smoke a cigarette. Both The Lancet and The New England Journal of Medicine report that smoking the plant is the best way to deliver the active ingredients effectively.

Second, the cannabis that is to be available must be grown and formulated intrastate and made available as an oral form by a New York processor. The New York State Department of Health is charged with crafting how vaporizable and edible active marijuana ingredient extracts are to be produced. Clearly this will be a much more expensive drug for consumers than simply making the raw plant flowers, leaves, and stems available as do the other states that allow medical marijuana. Drug manufacturers in the early Twentieth Century sold USP formulations of cannabis as extracts and tinctures. New York will probably have to turn to compounding pharmacy operations (or very similar entities) to provide these formulations in the future.

Third, in order to be eligible to access the available medical cannabis for registered dispensaries, a physician (or physician assistant or nurse practitioner) must certify that the patient has one of several “serious conditions” enumerated in the bill. In looking at the list, one is struck by how arbitrary it is. Moreover, for any prescriber interested in practicing evidence-based medicine, one is left to wonder how the list was generated other than by anecdotal report and political calculation since there are very few trials establishing safety and efficacy.

One could go on and on about the barriers, but even then how will the New York Department of Health deal with the fact that marijuana and its active ingredients the cannaboids are still listed in Schedule I of the Controlled Substances Act which criminalizes the possession and sale of these drugs? [White BD. Drugs, Ethics, and Quality of Life (2007). Pp. 61-84.] Or with its special formulations provisions, the Food and Drug Administration may have jurisdiction over how the extracts and tinctures are manufactured? The federal and state jurisdictional issues are substantial relative to separation of powers.

As noted, after a careful reading of the bill, one might wonder whether the availability of medical marijuana is part of a political game, or even a sham. And one might say a cruel one at that.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

1 comments | Topics: Bioethics and the Law , Drug Safety , Health Care Policy , Pharmaceuticals


Dash Thomas

Dash Thomas wrote on 01/28/15 10:31 PM

With conditions and situations like that, there is no doubt that several people will think the New York's medical marijuana as a hoax or a sham. Any improvement for 2015?

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