Commentary: Clearing The Smoke on Medical Marijuana, Part II

In the first installment of this series, I discussed the fallacy of rescheduling as part of the “medical” marijuana issue. This final part focuses on the issues brought up by the governors in their rescheduling petition: a so-called “consensus” opinion of doctors who approve of raw marijuana as medicine, and, the issue brought on by the California Medical Association that essentially says research on marijuana cannot go forward without legalization. I will tackle each at a time.

The governors’ petition asserts that there is a “consensus of medical opinion concerning medical acceptability of cannabis amongst the largest groups of physicians in the United States.” In support of this statement, the petition cites the American Medical Association’s (AMA) alleged “reversal” of its position that marijuana should remain a Schedule I substance. However, contrary to the governors’ petition, the AMA does not believe that there has been sufficient research to justify making herbal marijuana itself available as a prescription medication: “Despite more than 30 years of clinical research, only a small number of randomized, controlled trials have been conducted on smoked cannabis.”1

Furthermore, while the AMA’s Report does state that the Schedule I status should be “reviewed,” it limits the purpose of such review to the “goal of facilitating clinical research and development of cannabinoid-based medicines, and alternate delivery methods.”2 AMA does not recommend that marijuana should be rescheduled in order that it can be directly prescribed and dispensed in its raw form to patients. In fact, the AMA recommendation goes on to caution: “This should not be viewed as an endorsement of state-based medical cannabis programs, the legalization of marijuana, or that scientific evidence on the therapeutic use of cannabis meets the current standards for a prescription drug product.” In the body of its report, AMA further clarified its position:

The future of cannabinoid-based medicine lies in the rapidly evolving field of botanical drug substance development, as well as the design of molecules that target various aspects of the endocannabinoid system. To the extent that rescheduling marijuana out of Schedule I will benefit this effort, such a move can be supported.3

The term “botanical drug substance” is derived from an FDA guidance document: “Guidance for Industry: Botanical Drug Products.”4 It refers, not to herbal plant material, but to extracts or similar preparations of the active botanical components. Rather than accepting that marijuana meets the “current, modern accepted standard for what constitute medicine,” the AMA is essentially stating that research into crude marijuana plant material is a dead end.

Rescheduling is not necessary to make marijuana products available for research

A committee of the California Medical Association recently called for the rescheduling of marijuana “so it can be tested and regulated.” However, it is not necessary for marijuana to be rescheduled in order for legitimate research to proceed. Schedule I status does not prevent a product from being tested and researched for potential medical use. The FDA (and its Controlled Substances Staff or CSS) will allow an investigational product containing a controlled substance (including Schedule I substances) to be tested in clinical (human) trials if there is adequate evidence of safety from non-human studies.5 The CSA imposes stringent security, record keeping, and other requirements, but these apply equally to Schedule I and Schedule II substances.

Under the CSA, the only differences between Schedule I and II are rather technical:6 Before granting a Schedule I research registration, the DEA will separately inquire whether the FDA believes that the researcher is qualified and competent and the trial design will elicit scientifically valid data.7 A Schedule I research registration must be renewed each year, whereas research registrations for other controlled substances are valid for 3 years. Schedule I research registrations are protocol, as well as substance, specific. By contrast, a Schedule II registration is valid for research into all Schedule II substances and protocols. Physicians, if they possess registrations to prescribe and administer products containing controlled substances, may conduct research (if permitted by the FDA and the relevant ethics committee) on any Schedule II substance; they need not obtain a separate research registration from DEA.

These additional Schedule I restrictions can delay a research program but are not insurmountable. Furthermore, it may be possible to make minor amendments to the CSA to “equalize” Schedule I and Schedule II research requirements without necessitating a rescheduling of marijuana. Now that would be an interesting thing for governors and the CMA to call for, but apparently neither seemed bothered enough to do the homework required to make such an argument.

Today, Schedule I research certainly does go forward. In a recent pharmaceutical company-sponsored human clinical study investigating a product derived from marijuana extracts, the DEA registered approximately 30 research sites in the U.S. and also registered an importer to bring the product into the U.S. from the U.K., where it was manufactured (this is for a drug called, Sativex, which combines two of marijuana’s active ingredients). What other research projects are happening? That will be the subject of a soon-to-be released report I am working on – stay tuned.

We should also mention the marijuana-based medications already on the market today. Dronabinol (Marinol ®) and Nabilone (Cesamet ®) are concentrated, synthetic versions of the most active ingredient in marijuana – THC – taken as a pill. They are in Schedule III and Schedule II, respectively, and they have been shown to be effective in the treatment of nausea and vomiting caused by chemotherapy in people who have already taken other medications without good results. These have undergone FDA’s process and are completely legal under the Controlled Substances Act.

By contrast to the careful and detailed structure of the Controlled Substances Act, the governors’ petition offers no criteria or guidelines that would clearly identify the scope of legitimate “medical use.” The CMA report also misstates the facts. At present in California, and several other states, it is widely recognized that the concept of “medical use” of marijuana is highly questionable. For payment of a small cash sum, almost anyone can obtain a physician’s “recommendation” to purchase, possess, and use marijuana for alleged medical purposes. Indeed, numerous studies have shown that the most customers of these dispensaries do not suffer from chronic, debilitating conditions such as HIV/AIDS or cancer and are instead otherwise healthy individuals.8,9 Both sides of the argument agree that this system has essentially legalized marijuana for recreational use, at least amongst those individuals able and willing to buy a recommendation.10 The governor’s petition would potentially expand that system on a national scale, permitting any physician in any state to prescribe any form of marijuana for any medical condition. The CMA call, while a great way to generate publicity on legalization, is also predicated on a false assertion that the only way to do research into marijuana is to legalize the drug. Sadly, vociferous calls for rescheduling and legalizing like these simply further muddle and confuse an already highly charged debate.

Kevin A. Sabet, PhD, Policy Consultant and Assistant Professor, University of Florida, College of Medicine, Division of Addiction Medicine, Department of Psychiatry. To read more from Dr. Sabet, visit www.kevinsabet.com or follow him on Twitter @kevinsabet.

[1] Id. at p. 15.

[2] AMA, Council on Science and Public Health, “Use of Cannabis for Medicinal Purposes,” http://www.ama-assn.org/resources/doc/csaph/i09csaph3ft.pdf (2009) (hereinafter AMA Report).

[3] Id. at p.16.

[4] http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070491.pdf.

[5] In order for any investigational product to move into advanced clinical research (and ultimately to new drug approval), many additional criteria must be met. Robust data must demonstrate a product’s pharmacological activity, quality (including consistent composition, extent of impurities, and stability), toxicity of various types, and efficacy in a particular patient population for a specific medical condition.

[6] See AMA Report, page 9.

[7] 21 U.S.C.§823(f).

[8] O’Connell, T and Bou-Matar , C.B. (2007). Long term marijuana users seeking medical cannabis in California (2001–2007): demographics, social characteristics, patterns of cannabis and other drug use of 4117 applicants. Harm Reduction Journalhttp://www.harmreductionjournal.com/content/4/1/16.

[9] Nunberg, Helen; Kilmer, Beau; Pacula, Rosalie Liccardo; and Burgdorf, James R. (2011) “An Analysis of Applicants Presenting to a Medical Marijuana Specialty Practice in California,” Journal of Drug Policy Analysis: Vol. 4: Iss. 1, Article 1. Available at: http://www.bepress.com/jdpa/vol4/iss1/art1.

[10] According to Allen St. Pierre of NORML, “in California, marijuana has also been de facto legalized under the guise of medical marijuana.” See Transcript of Don Lemon CNN Television Show with Kevin Sabet and Allen St. Pierre: http://transcripts.cnn.com/TRANSCRIPTS/0905/09/cnr.04.html. Accessed January 22, 2012.

23 Responses to Commentary: Clearing The Smoke on Medical Marijuana, Part II

  1. PWKaplan | February 17, 2012 at 1:01 pm

    This is a perfect example of reasoning from your conclusion. Mr. Sabet selects only the arguments that support his preconceived notion that cannabis should not be rescheduled. Whether you agree with him or not, HIS arguments are ridiculous–who cares whether the AMA endorsed fully rescheduling or limited rescheduling? The AMA’s position doesn’t make it right or wrong. The rescheduling debate should focus on what has the most potential to benefit people who are suffering with cancer and other symptoms that might be alleviated by cannabis, not on who might be allowed to do research.

    • Denise L | February 21, 2012 at 12:31 pm

      The article’s author seems to be relying on circular logic and comes to a conclusion that conflicts all I’ve seen & experienced when I worked with cancer patients at our cancer treatment center and with veterans through my husband.

  2. Fred C, | February 17, 2012 at 1:24 pm

    I read both parts of this article and did not find a single convincing argument for not rescheduling. I found a lot of obfuscation and restating of the obvious but not a single reason to not grant the governor’s request. Making it sched II does not make it legal or promote its use. How about we let the FDA do fundamental research on the medical value of tobacco and since it is the number one killer drug in the world, reschedule it to schedule I. After all, it is an addictive killer drug with absolutely no medicinal value. People who fight research into anything that might replace this killer are immediately suspect to me and I wonder who they are paid by.
    Let them do research. Let’s see what they come up with. P.S. I am not in favor of making pot legal. There are enough brain-addled people out driving already.

    • pfroehlich2004 | February 23, 2012 at 8:02 am

      I agree that we don’t need more brain-addled drivers on the road. However, the available evidence doesn’t support your belief that allowing legal access to marijuana will lead to an increased prevalence of impaired driving.

      Data collected by the National Highway Transportation Safety Administration shows that motor vehicle fatality rates (deaths per 100 million vehicle miles driven) have, on average declined faster in states with medical marijuana laws than in those without them.

      Of the ten states which had passed medical marijuana laws by 2004 (CA,AK,OR,WA,ME,CO,HI,NV,MT,VT), seven experienced subsequent declines in the MVFR that were greater than the national average.
      (Source: http://www-fars.nhtsa.dot.gov/States/StatesFatalitiesFatalityRates.aspx).

      Of course, this doesn’t mean that legal access to marijuan automatically improves traffic safety, but it clearly does not correlate with decreased traffic safety.

  3. Allan Barger | February 17, 2012 at 2:32 pm

    As a resident of California, any observant person can see that the medical cannabis law passed by public referendum has produced nothing more than a legalized “drug diversion” program where a substance with some limited medical potential has been made available to massive number of people intent on abusing the substance. Research has shown an increase in cannabis-related DUI’s and other problems since this system was legalized.

    • Richard P Steeb | February 18, 2012 at 11:22 am

      There has been a documented 9% decrease in traffic fatalities in the 16 states which have medicinal cannabis. How does THAT square with your statement?

    • Tony Graveline | February 21, 2012 at 9:24 am

      My question is if there are approved medications that show the benefits of THC based products on symptoms, what is the legalization movement pushing, legalized highs because they want to smoke, or using approved THC to reduce medical symptoms? To be approved, the adverse affects need to be reduced and they could be if the focus was only on the benefit of THC on targeted symptoms and not the high produced from smoking.

      • pfroehlich2004 | February 23, 2012 at 11:38 am

        Tony, I believe we’ve had this conversation before. Feeling “high” is one of the results of having THC in your bloodstream. It matters not if said THC was smoked, vaporized, eaten, or drunk. Nor does it matter if the THC was contained in a gel capsule, an aerosol spray, or the raw cells of the marijuana plant (the horror!). THC in the bloodstream = high, get it?

        Just as you cannot use opiates to control pain without feeling “high”, one cannot use THC therapeutically without feeling “high”. By taking less, one can feel less “high”, but this also reduces the palliative effect.

  4. doogiem | February 17, 2012 at 4:08 pm

    Dr. Sabet: Talk about a smoke screen! The biggest smoke to be cleared here is the fact that there is such a thing as a “bad” law. And bad laws, in part, shape the discussion. We spent years discussing whether or not blacks (and women) should vote, whether or not alcohol or gambling should be legal. Once the bad law was corrected/repealed, the discussion changed – we discussed how blacks and women would register to vote, how alcohol would be regulated and taxed, and how funds from casinos would be used towards the prevention/treatment of gambling addiction. To really “clear the smoke” on this topic, realize that there are actually two topics: #1 – cannabis as medicine (– the area that Dr. Sabet is addressing); and #2 — cannabis as a prohibited recreational substance (the area he is not addressing). And now we’re spending time and money and energy debating and clarifying topic #1 only because topic #2 exists! Legalize and regulate cannabis. Then let’s move on to the other topics that will become (more) relevant: how to tax and regulate cannabis; how to use former criminal justice funds on prevention and treatment, etc.

  5. Josh | February 17, 2012 at 4:27 pm

    The fact of the matter is that most people who use medical marijuana under state law actually do need it. These dying patients cannot wait for the FDA. The average age of the medical marijuana patient in Colorado is 42. There are thousands of cancer patients who need medical marijuana in a smoked form for the nausea because many of them vomit when they try and take a pill for nausea. Thousands of individuals in Colorado have been able to substitute marijuana in replace of more harmful and addictive narcotics. Interestingly, less than 25% of Coloradoans suffering from chronic pain actually use medical marijuana. Kevin Sabet appears blinded by his bias (he used to work for the ONDCP which is required by law to opposed medical marijuana.

  6. Joe Miller | February 17, 2012 at 4:51 pm

    I respectfully submit that any healthcare professional that supports laws that place the responsibility for the production and distribution of a drug into the hands of criminal predators via the black market should have his/her license to practice voided.

    • JR Dallas | February 20, 2012 at 1:45 pm

      Yea Joe… Legalizing is an important issue, but what the distribution? As I mentioned after the 1st part, if the distribution continues as it is, how will be protect our children? And the (pardon my French) Stupid? no offense if you relate tha that last comment, but the way this is distributed opens doors for abuse by those who do not have the ability to think for themselves and any short or long term consequences. I know, I know, the majority that use don’t abuse, but how do we protect the minority that will? that will do damage to themselves, their families, their communities, their reputations, employment? I know, I know, most who use claim they can continue to live a productive live, but who will protect the minority if distribution is not regulated? I know, I know, same argument for alcohol, however it’s kinda late for that. But can’t we learn from history & insure that MJ doesn’t fall into the same abuse that has happened to alcohol? Just a few thoughts from someone concerned about the minority & their families.

      • JR Dallas | February 20, 2012 at 1:50 pm

        PS – excuse the spelling in the previous post, sometimes my fingers don’t listen & I need remember to proof-read. I’m totally human & the older I get the more I realize I don’t know. SO I don’t want to argue with anyone, just do whats best for our society, & protect the innocent.

        • Diego | February 28, 2012 at 5:30 pm

          Regarding your comment about protecting the innocent, if marijuana laws are reformed they are available through a dispensary. Tobacco is and unfortunately always will be more readily available, every grocery store and gas station. Seems to be people turn a blind eye to the tobacco and pharmaceutical drugs that are ever more rampant in our schools and demonize marijuana use by adults.

  7. meltee | February 17, 2012 at 7:26 pm

    Part 1 appeared to say marijuana is not sufficiently well defined to be allowed to be prescribed, yet it is sufficiently well defined to be banned from use. This position, combined with the references to the legitimacy of manufactured extracts from marijuana reflect a larger “battle” in the field of medicine. “Natural” vs “chemical” is a core element of dispute between drug manufacturing companies and supporters of “natural medicine.” Powerful manufactured drugs with proven side effects more severe than those attributed to marijuana are approved for use, while unprocessed marijuana and is banned, and other herbal medicines are dismissed as snake oil.
    That aside, his easy dismissal of the concerns about the ability to conduct research is worth a challenge. The only legally available resource for marijuana in for research in the US is from a federally operated farm. Even if a researcher can jump through the extra hoops to get a research study approved, it is virtually impossible to get a sufficient quantity of marijuana from the feds to actually carry out a study. Even if a researcher wanted to study a controlled extract of marijuana, they have to obtain some sort of marijuana from which the extract can be created. Thus, some loosening of the grip of Schedule I status is necessary in order to foster research into marijuana’s safety and efficacy.

  8. Dwayne | February 18, 2012 at 6:02 am

    This is a bunch of mumbo jumbo! I don’t care about the AMA,DEA,CIA,or the rest of these clowns that like to control a free country.
    What I do care about is Marijuana and the Bible
    http://www.ebeneezer.net
    Check it out very interesting reading

  9. Terrance | February 18, 2012 at 8:38 am

    This is convincing and well reasoned. Thank heavens for Kevin Sabet’s insightful commentary which seems to be everywhere these days! Finally someone to give Ethan Nadelman a run for his money!

  10. Carl Olsen | February 18, 2012 at 9:28 am

    This is a great article. Nothing in Schedule I of the federal Controlled Substances Act has ever been accepted by any state for medical use. Marijuana has now been accepted for medical use in 16 states and the District of Columbia (with Congressional approval). So, it’s fairly clear marijuana no longer meets the federal mandate for Schedule I that nothing in Schedule I can have an accepted medical use in the United States. Where we see the glaring error is suggesting that it belongs in Schedule II. Coca plants and opium poppies, for example, are both in Schedule II, but neither of those plants is prescribed in its natural form. It’s a huge mistake to couple a petition to remove marijuana from Schedule I with a request to have it transferred to another schedule. Remove it from Schedule I and let Congress figure out what to do with it. Congress has obviously just recently allowed the District of Columbia to implement its medical marijuana program, so this should not be difficult. Congress can let the states figure out what to do with it. Thanks again for such a well-reasoned article!

  11. Ben House | February 18, 2012 at 11:12 am

    Graduate school taught me that organizations take on a life of their own and at that point their primary focus is maintaining and growing their power and not the primary mission that was the original purpose. The AMA, big pharm, the legal community and the treatment community and others seem to all fit this model developed by Max Weber. He called it bureaucracy.

    The war on drugs has created two huge industries that maintain the problem more than work to solve it, the corrections and treatment industries.

    When I read articles like this I am reminded I had some good education.

  12. Richard P Steeb | February 18, 2012 at 11:21 am

    I have enjoyed Cannabis daily since 1968, at which time my disabling asthma “subsided”. Smoked or vaporized or ingested Cannabis has been an important part of my glaucoma IOP control for the past twelve years. As a signatory to the Petition to Reschedule Cannabis, I find Sabet’s arguments weak and unpersuasive. The prohibition of Eath’s most widely beneficial plant species is a crime against humanity that is shortly to be eradicated. Watch us, Kevin!

  13. Trevelyan | February 19, 2012 at 12:27 am

    It really blows my mind when I hear this type of argument. The simple fact is non-toxic cannabis can help people with pain, cancer, MS and many other diseases. The plant has never killed a person by its use alone. Doesn’t that somehow speak to it safety? It doesn’t constipate or have the risk of overdose like opiates(oxycodone, vicodin, hydrocodon). Yes it can be abused but the herbal plant is medicine PAL! For God’s sakes everything that can help humans with illness does not need to be made in a test tube!

  14. Mary Lynn Mathre | February 19, 2012 at 1:00 pm

    I agree with the above statements regarding Dr. Sabot’s articles as a smoke screen and a lot of obfuscation. It has been extremely difficult for researchers to conduct clinical research on cannabis – more difficult than for other schedule I drugs, despite the fact that it has a remarkable safety margin. I strongly suggest that if Dr. Sabot wants to fully understand the potential value of whole cannabis, that he attends The Seventh National Clinical Conference on Cannabis Therapeutics that will be held on April 26-28, 2012 at the Loews Ventana Canyon Resort in Tucson. This accredited conference will host an international faculty of cannabis researchers. The theme is: The Endocannabinoid System: Clinical Implications for Health Care – Dr. Sabot, if you could open your mind to this new science on the human body, maybe the light bulb will come on in your head to help you see the enormous value of this medicine in PREVENTING as well as treating many illnesses. More info at http://www.medicalcannabis.com

  15. Angela Denes | February 20, 2012 at 2:55 pm

    Regarding THE DRUG ADDICTION TREATMENT EXPANSION ACT, S. 45 that went into effect 8-2-2005.
    The ACT requested the federal government to lift the number for medical practitioners prescribing drug addiction treatments, from 30 to 100 patients.
    Since 2005, numbers of addicts have more than quadrupled. Physicians, who are able to become “Qualified Practitioners,” and prescribe treatment such as Suboxone, are ridiculously limited compared to the number of medical practitioners who can prescribe true opiates. The qualified practitioners are either at their limit, turning away patients, or quickly approaching the 100-patient cap.
    This anomaly in the current law severely limits the ability of patients to get treatment for their drug addictions. The intentions of the original policy to ensure proper oversight of drug addiction treatment inadvertently discourages most physicians from practicing drug treatment because of the restrictions, license, and insurance that are difficult to obtain. Though, they can prescribe patients the opiates that may create dependence to begin with.
    In the mean time, here in Ohio, our House Bill 86 has discouraged our criminal justice system from sending non-violent drug addicts/pushers to jail. However, options for treatment or, immediate help with no waiting list are extremely limited. The addicts are returning to the streets unable to get help; making a living by selling more drugs to our younger society and engaging in crime. (Stealing goods to pawn for drug money)
    The Data 2000 restrictions were originally intended to deter prescription-writing mills, however with treatment such as Suboxone, withdrawal symptoms are eliminated without producing euphoria. Patients are able to remain productive while overcoming their drug addiction. Counseling is not a requirement for successful outcomes however, it is recommended at the patient’s discretion.
    I am urging you to change this piece of legislation as the solution really is, quite simple.
    One: Request that doctors prescribing opiates are easily able to prescribe the choice preferred method to resolve opiate dependence such as Suboxone, as the physician is aware that from the onset of opiate treatment, that addiction may be a probable side effect.
    Or….
    TWO: Expand the number of patients that physicians are able to treat with no limit, as we know that opiate addicts are growing at an alarming rate, as well as deaths from overdoses and babies being born addicted who face for certain a lifetime of health complications from the addiction in utero.
    By allowing medical practitioners the ability to treat an unlimited number of addicts and intervene with treatment at the early onset of addiction, we have the potential to save millions of lives and billions of dollars.

    America wants you to do this.

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