Posted by Sunil Aggarwal
After this blog was posted, prescribing medical professionals have signed a letter acknowledging that cannabis has medical use and should be rescheduled.
Most would agree with the premise that medical decisions regarding the appropriateness of a treatments are best left to doctors and other medicine prescribers in conjunction with patients. When it comes to herbal marijuana or cannabis, Congress and federal regulatory authorities have taken it upon themselves to judge across the board whether this substance has a currently accepted medical use in treatment in the United States, taking little or no input from clinicians who are responsible for actually providing treatments in this country.
Responding to the fact that nothing has been done to organize individual medical professionals to clearly state with one voice to the federal regulatory authorities that there are indeed currently accepted medical uses for cannabis (aka herbal marijuana) in the United States today, the medical prescribers on the board of ASA have started a sign-on letter to give the opportunity for their colleagues to stand and be counted. On Friday August 31st, in collaboration with fellow ASA board and staff, an open national-sign on letter was launched. This sign-on letter is in advance of the federal DC Circuit Court of Appeals hearing on October 16 when judges will consider questions regarding the appropriate classification of marijuana or cannabis in the drug scheduling framework.
Invited signatories to the letter are licensed physicians, physician assistants, and advanced registered nurse practioners – professions with prescribing privileges – who recognize that safe, currently accepted medical uses in treatment for marijuana presently exist in the United States. The letter cites national medical professional consensus statements which signal that the current Schedule I status of cannabis is suspect.
Maintaining the Schedule I status for marijuana in federal law requires drug regulatory authorities to assert and maintain that no accepted medical use in treatment in the US currently exists for marijuana. To do so in the face of the accumulated evidence requires strained and ill-conceived arguments. In their July 2011 decision rejecting ASA’s petition to reschedule marijuana (the appeal of which is the subject of the upcoming hearing), the DEA included the required scientific assessment from the US Department of Health and Human Services (HHS) which had been prepared 5 years prior. Writing on December 6, 2006, HHS found that there were no “NDA-quality [new drug application] studies that have assessed…efficacy and…safety…of marijuana for any medical condition.” They went on to say that “at this time, it is clear that there is not a consensus of medical opinion concerning medical applications of marijuana,” that “a material conflict of opinion among experts precludes a finding that marijuana has been accepted by qualified experts”, and finally that there is no opportunity for “adequate scientific scrutiny” of the existing scientific evidence as the data were “only in summarized form, such as a paper published in the medical literature, rather than in a raw data format.”
It is without merit to assume that the only way that a drug or substance can be judged to have accepted medical use is through the completion of “NDA-quality studies,” which is another way of saying “Phase III” randomized controlled trials. There are many medically accepted uses of drugs for indications that have not undergone Phase III level testing. For example, take the use of platelet-rich plasma (PrP) injections for the treatment of Achillies tendonitis or tennis elbow. While it is being prescribed by a great number of physicians and being reimbursed by insurance companies, there are no completed Phase III “NDA-quality” studies that have been done to evaluate this medical application. However, it would be wrong to say that that PrP has no currently accepted medical use in treatment in the United States – just ask the American Academy of Physical Medicine and Rehabilitation or other medical specialty societies who hold, sponsor, or advertise training workshops on PrP. Clearly, medical acceptance for treatments depends on presently accepted clinical practices by the medical community. Given that the two largest physicians groups in the United States, the AMA and the ACP, have both come on record saying that the Schedule I status of marijuana needs to be reviewed and that, according to the ACP, such a review would likely lead to reclassification of the drug, it is not accurate to say that there is not a consensus medical expert opinion about the medical utility of marijuana. While it is true that these positions of medical associations were formally taken after the 2006 position prepared by the HHS, they were available at the time the DEA issued its ruling.
In fact, many more patients have been involved in randomized-controlled clinical studies involving cannabis and cannabis-based medicinal extracts than many other drugs. While only a few of these studies rise to the level of Phase III, that does not mean that a strong evidence base is lacking (nearly all controlled clinical trials of cannabis done in the United States have been positive). One pharmaceutical company in England, GW Pharmaceuticals, has conducted large Phase III studies with a cannabis-based medicinal extract produced directly from liquid CO2 extraction of herbal cannabis. While the company would like to contend that studies related to this extract don’t apply to marijuana, as they indicated in a letter from their lawyer to HHS, it is hard to see how they do not apply to marijuana given that the long-standing enforced definition of “marihuana” in federal law since 1937 has been “all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds, or resins.” Certainly the DEA has recently created a separate classification for cannabis extracts in their Scheduling schema, but it is clear that this is little more than pharmacolegal jujitsu to somehow create a privileged parsing of “marijuana extracts” from “marijuana” for the benefit of drug pipelines.
HHS’s claim that “raw data” is needed and that published papers in the medical literature will not do is bizarre and unusual. Medical education, research, and evidence-based consensus-statement writing relies on the same pool of data with findings commonly presented in journal articles. Not having it all together in “one big paper” is really no reason to deny judgment about accepted medical use of marijuana.
The prescribers signing on to the letter are able to judge based on their expertise developed out of clinical experience, study, and collegial discussions, that marijuana or cannabis has an accepted medical use in treatment in the United States. With likely over 10,000 physicians authorizing patients to used cannabis in medical marijuana programs, which have been around for 16 years, and with the string of positive outcome clinical trials of cannabis and cannabis extracts, there is more than enough medical experience and evidence available to recognize that a currently accepted medical use in treatment in the United States exists for marijuana. If strong scientific evidence and clinical professional opinions count for anything in policy, then it is time to re-schedule/de-schedule marijuana.
Sunil Aggarwal, M.D., Ph.D., is an Americans for Safe Access Foundation Board Member