If marihuana is to be used as a medicine it should be treated as such and subjected to the Food and Drug Administration's approval process. The following memo, on S.4406-A (Savino) /A.6357 (Gottfried), has been distributed to the Members of the Legislature.
An act to amend the public health law, the tax law, the general business law and the penal law, in relation to medical use of marihuana.
Marihuana is not medicine. If it is to be considered as medicine, it should be treated as such and subjected to the Food and Drug Administration's approval process that includes clinical trials to determine its efficacy as a medication. On February 27, 2014 the Federal Drug Administration did designate cannabidiol as an "orphan drug," but only for treatment of Lennox-Gastaut syndrome. This should serve as an encouragement to medical marihuana advocates that science is indeed studying the possible uses of marihuana, but also as a reminder to the Legislature that it is premature to classify marihuana as a medicine. Legislators are not doctors and research scientists. The proposed "feel-good" legislation seeks to bypass clinical trials that would determine marihuana's true efficacy as a medication.
In the federal court case of Alliance for Cannabis Therapeutics v. DEA 15Fed 1131 (D.D.C. 1994) the U.S. District Court accepted the five-part test for determining whether a drug is in "currently accepted medicinal use." Id at 1135. The test requires that:
- The drug's chemistry must be known and reproducible;
- There must be adequate safety studies;
- There must be adequate and well-controlled studies proving efficacy;
- The drug must be accepted by qualified experts; and
- The scientific evidence must be widely available.
Applying these criteria to crude marihuana, the court found that the drug had no currently accepted medical use.
Drug approval must be based on science, not merely what certain segments of society may desire.
A major study, Early Findings in Controlled Studies of Herbal Cannabis: A Review, concluded that despite the widespread public interest in the therapeutic potential of herbal cannabis.... "the data alone fails to make the case that crude, smoked cannabis should be made available to patients." Numerous other studies have replicated those findings.
The National Council on Alcoholism and Drug Dependence (NCADD), the American Society of Addiction Medicine (ASAM), the New York Society of Addiction Medicine (NYSAM), the American Medical Association (AMA) and numerous other national and state organizations are also opposed to marihuana as medicine in smoked or eaten form.
Despite the claims that this bill is strict, it is not.
- Certification for pot is good for an entire year but physicians may only prescribe Schedule 2 drugs for 30 days. Under this proposal, there is no requirement to specify dosage or refill requests. This is unlike prescribing any form of medicine. There is also no requirement for reevaluation. The current bill language would permit daily prescriptions for medicinal marihuana. This is a loophole ripe for abuse.
- Certification can be issued not only by physicians, but by physician's assistants or nurse practitioners. This is contrary to the accepted roles of PA's and NP's since they are not able to diagnose and treat many of the qualifying conditions. Under this legislation, the practitioner is not even required to have a continuing relationship with the patient. An individual could walk into a clinic, get a certification, and walk out without any real relationship or intent to return to the healthcare provider.
- Qualifying conditions are much too broad. Specific conditions should be listed in the legislation and linked to a requirement that they be "severely debilitating or life-threatening." Under the current bill language, a patient can qualify merely because he or she has a condition, regardless of the condition's severity.
- The caregiver provision lacks verification. A caregiver can care for up to five patients. This means that one caregiver could obtain 12½ ounces at any given time.Under the bill, a patient can designate two separate caregivers and can designate an unlimited number of additional caregivers if a caregiver is a member of immediate family or physical household. Yet no verification of a caregiver's relationship to the patient or residency is required. Again, this allowance could easily lead to rampant abuse.
- The caregiver provision lacks serious safeguards. The proposed legislation does not require a background check for the caregiver. The caregiver could be a convicted narcotics dealer.
The New York State Conservative Party is strongly opposed to this proposal whether it is a stand-alone bill, buried in the budget or as an executive order. If there is some hope in the use of cannabidiol, then we suggest that New York follows what South Carolina recently did and propose a bill strictly for the use of cannabidiol under the FDA "orphan drug" designation. New York's current proposal is disingenuous to the seriously ill and ultimately creates an open door to a myriad of societal problems.