Blog No. 57 Charlotte’s Web, Medical Marijuana and the Vagaries of the Law

There has been considerable movement afoot in the world of marijuana in the past year. In November, voters in Alaska, Oregon and the District of Columbia passed referenda authorizing and regulating the sale and use of marijuana. They joined Colorado and Washington State, which had previously adopted such laws. In Florida, a referendum authorizing the use of medical marijuana drew the support of a majority of voters but failed to gain the required approval of 60%. In June, however, the Florida legislature, had passed  a narrower law authorizing only a specific, non-euphoric, form of medical marijuana, known as Charlotte’s Web. A total of 22 states have now adopted laws authorizing some form of medical marijuana.

The response at the federal level has been mixed and confused. Marijuana in all forms remains on Schedule 1 of the Controlled Substances Act. Schedule 1 is the most restricted category and is reserved for substances having “no currently accepted medical use in treatment in the United States.” It is essentially the government’s position that there is no such thing as “medical marijuana” and possession of marijuana, however described and whatever its purpose, remains a federal crime. On the other hand, the Department of Justice, has shown no desire for a head-on battle with the states that have legalized marijuana. On August 29, 2014, the Department issued a Memorandum indicating that it would not challenge the state laws in question and would limit its law enforcement concerning marijuana to specified activities said to involve “enforcement priorities that are particularly important to the federal government.” Such activities included:

• the distribution of marijuana to minors;
• revenue from the sale of marijuana from going to criminal enterprises, gangs and cartels;
• the diversion of marijuana from states where it is legal under state law in some form to other states;
• state-authorized marijuana activity from being used as a cover or pretext for the trafficking of other illegal drugs or other illegal activity;
• violence and the use of firearms in the cultivation and distribution of marijuana
• drugged driving and the exacerbation of other adverse public health consequences associated with marijuana use;
• growing of marijuana on public lands and the attendant public safety and environmental dangers posed by marijuana production on public lands;
• preventing marijuana possession or use on federal property

Consistent with existing policy, the Justice Department Memorandum provided neither recognition of, nor special consideration for, medical marijuana. In December, however, a bi-partisan amendment to the omnibus spending bill signed by the President recognized the rapidly increasing public support for medical marijuana. The Rohrbacher-Farr amendment stated that “None of the funds made available in this Act to the Department of Justice may be used, with respect to the States of…[list of states]…, to prevent such States from implementing their own State laws that authorize the use, distribution, possession, or cultivation of medical marijuana.”

On the heels of that law, CNN last week re-broadcast a documentary on marijuana produced and narrated by Dr. Sanjay Gupta, CNN’s chief medical correspondent and a noted neurosurgeon. (Part 1 of the documentary had initially been broadcast on August 21, 2013 and Part 2 on March 11, 2014. Both parts are available on YouTube.) The documentary is a good introduction to many of the issues involving marijuana, and in particular medical marijuana, and we recommend it to followers of RINOcracy.com.

The essential message of the documentary is that, while there are definite risks associated with recreational marijuana, particularly for younger users, there are significant benefits, both present and potential, from medical marijuana. This not only put Dr. Gupta at odds with the position of the federal government, but constituted a reversal of his own previous position. Dr. Gupta, however, has declined to endorse the legalization of all marijuana. That is a position we support. While we are persuaded of the benefits to be gained from medical marijuana, we are wary of the risks of recreational use in terms of short-term behavior and potential long-term brain damage for young people.

The Gupta documentary notes the risks identified with marijuana, canvases the legal restraints on its use, and describes ongoing and proposed research in this country, Great Britain and Israel. The principal focus, however, is on individuals whose use of marijuana has given them relief from a variety of severely debilitating conditions. One of the most compelling stories concerns a young girl, Charlotte Figi, who suffers from a form of epilepsy known as Dravet Syndrome. When she suffered seizures of increasing frequency and severity and a range of other problems not responsive to medication, her parents felt they had nowhere to turn. Fortunately, however, the Figis live in Colorado and medical marijuana was an option.

The Figis were further fortunate in finding a grower who had developed a strain of marijuana with a very low proportion of THC (tetrahydrocannabinol), the ingredient that produces a high for recreational users, and a much higher proportion of CBD (cannabidiol) that produces a therapeutic response. The Colorado grower, a firm of six brothers in the Stanley family, were able to produce an extract from the plants that had a seemingly miraculous effect on Charlotte: she went from having 300 seizures in a week to just one, and for the first time was able to engage in normal childhood activities. In her honor, the extract was named “Charlotte’s Web” after the E.B. White classic, and as of last August, according to the Gupta documentary, 41 families were using it and dozens more were on a waiting list. Although the medicinal (and non-euphoric) marijuana is the least profitable strain grown by the Stanley brothers, it now represents 80% of their business. The success of Charlotte’s Web also has inspired legislatures not only in Florida, but in several other states.

One of the problems pointed out by the documentary is that under federal law, Charlotte’s Web and other forms of medicinal marijuana could not be transported across state lines. That remains the case, and the August 29 Memorandum of the Department of Justice identified as one of the priorities still subject to prosecution, “the diversion of marijuana from states where it is legal under state law in some form to other states.” As a result, a number of families uprooted their homes to move to Colorado to obtain the relief they needed. As medical marijuana becomes legal in more states, such relocations should become less needed, but the process is often not easy. The documentary highlighted the situation of a family in New Jersey who found that, even after the state had approved medical marijuana, they could not find the formulation that they needed. And in Florida the initial regulations adopted by the state to implement the Charlotte’s Web law were successfully challenged in court, by growers asserting that the regulations were too restrictive, and the state has now gone back to the drawing board while patients wait.

Another major problem arises from paradoxical aspects of the federal government’s position with respect to medical marijuana. While the government has relaxed its law enforcement efforts, obstacles to research remain in place. And although the government declines to recognize any benefits of medical marijuana, it makes it difficult or impossible to conduct research to confirm such benefits (as well as define any risks that may be involved.) A further irony appears from the fact that the government itself owns a significant patent on one of the ingredients but apparently refuses to license it. Part 2 of the documentary included this interesting colloquy:

GUPTA: Like any drug in the United States, cannabis would have to go through rigorous testing, research and approval by the FDA. But after that, things start to get tricky. You see, marijuana also needs the approval of other governmental agencies like the National Institutes of Health and the Drug Enforcement Administration. This is, of course, difficult, if not impossible.  Why? Because in the United States, marijuana is illegal and classified by the government as a Schedule 1 controlled substance. That means it’s considered to be among the most addictive drugs and is not recognized as having any medicinal benefit. And that’s why what I’m about to tell you is so ironic.

DR. MICHAEL BOSWICK, RESEARCHER, MAYO CLINIC: The irony is that the federal government has patented one of the important chemicals in the — in the plant.

GUPTA: The government of the United States has a patent on a substance for medicinal purposes at the same time that they say it has no medicinal purpose?

BOSWICK: Exactly.

GUPTA: Mayo Clinic researcher Dr. Michael Boswick is talking about United States patent number 6630507. It’s held by the U.S. Department of Health and Human Services for the exclusive use of cannabinoids for certain treatments.

BOSWICK: I was stunned and it really feels to me like the dog in the manger, that the federal government is sitting on this wonderful thing — wonderful thing, and not letting anybody else do anything with it.

GUPTA: And when we went to the government to ask about it, none of the agencies involved would comment.

DR. ORRIN DEVINSKI [Director, NYU Comprehensive Epilepsy Center]: We’re being handcuffed by the government, preventing us from doing the right trials.

At the state level, some who oppose legalizing recreational marijuana, will have concerns as to whether authorization of medical marijuana may in fact turn out to be a road to recreational use. It is likely that such concerns animated Jeb Bush’s opposition to the Florida referendum:

Florida leaders and citizens have worked for years to make the Sunshine State a world-class location to start or run a business, a family-friendly destination for tourism and a desirable place to raise a family or retire. Allowing large-scale, marijuana operations to take root across Florida, under the guise of using it for medicinal purposes, runs counter to all of these efforts.

It is not known, however, whether Bush had any problem with Florida’s more narrowly drafted Charlotte’s Web bill authorizing only a non-euphoric form of medical marijuana. Significantly, Senator Marco Rubio, like Bush, opposed the referendum but supported the earlier action by the legislature. Rubio called the referendum a “ruse” that could allow people with dubious medical needs to get access to the high-inducing form of the drug:

You’ve seen how this has been abused in many parts of this country. It’s the reality that there are states now that you go in and can have a doctor write you a prescription for something that you are really just using for purposes of acquiring legally a recreational drug.

We believe that the concerns articulated by Bush and Rubio are legitimate. If recreational marijuana is to be legalized, it should be done explicitly, and after full consideration of the risks and benefits, rather than through a back door. Nevertheless, it should be possible to satisfy concerns over the authorization of medical marijuana by adopting laws that are carefully drafted and conscientiously administered. The scope of such authorizations—whether they should be limited to non-euphoric forms of marijuana—is a subject for reasonable debate. Such a limitation would reduce or eliminate the risk of unintended use, but would also limit the range of conditions that could be successfully treated. In any case, it seems clear that there is no valid reason for a blanket rejection of any and all forms of medical marijuana.

By the same token, the federal government should act to remove at least some forms of medical marijuana from Schedule 1 and take a pro-active role to encourage and support research concerning this promising medicine.