By Kevin A. Sabet

Published February 17. 2012

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 Journal, http://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.

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By Bill O’Reilly

Published February 15, 2012

The media have no bleepin’ clue how to cover the death of Whitney Houston. That’s because she was slowly dying for years and many in the press simply averted their eyes.

It was ultra-disturbing that a beautiful woman blessed with an extraordinary singing voice chose a self-destructive path in full view of the world. I mean, here is a person who signed a $100 million recording contract, actually sold 170 million albums and commanded high six figures to deliver a 90-minute concert. Houston was a genuine international star, and yet she often was seen in public disheveled and confused, her substance addiction apparent. The media simply did not know what to say.

We live in a time in which addiction is categorized as a disease, and to do what Nancy Reagan once did and urge people to reject narcotics is considered uncool. How many young performers do we see doing public service announcements warning children to avoid intoxication? Right now, I can’t think of one.

The national media pride themselves on being non-judgmental unless you are against abortion. Then you are dismissed as “anti-woman” or as a religious zealot. But in the arena of personal behavior, there’s an excuse for just about every nonviolent activity and bad decision.

There is no question that some of us have a history of addiction in our families. There are folks who can use drugs casually and avoid dependence, but they are the exception. Once a person decides to dabble in cocaine, or opiates such as heroin and OxyContin, they are putting themselves at grave risk. And they know it. There are legions of famous people who wound up dead just like Houston. From Elvis Presley to Michael Jackson, the signposts are impossible to miss. No matter how rich and powerful you are, drugs can and will destroy you.

The current medical marijuana ruse is a great example of a society walking away from a responsible position. Ask any drug rehab counselor, and he or she will tell you that pot often leads a person to harder drug use and is mentally addictive itself. Yes, most people can function while stoned. But the more you alter your mind the more your perspective on life changes. Believe me, I know people who get stoned or drunk every day. They become incredibly desensitized to those around them.

On the kid front, the situation is dire. Once a child enters the world of intoxication, their childhood is gone. Presto, they are jaded. That’s how dangerous drugs and alcohol are to immature minds. Society has an obligation to protect its children, not to tacitly accept or embrace mind-altering agents such as marijuana.

Houston, however, was an adult who made a decision to embrace the drug life. Reports say she tried to rehabilitate herself a few times, but you know how that goes. Once a person enters the hell of addiction, there is no easy way out.

And that’s how the Whitney Houston story should be covered. As a cautionary tale. Another life vanquished by substance abuse.

By Kevin A. Sabet, PhD

Published February 14, 2012

Medical marijuana is a source of confusion, frustration and ignorance among many of us. On the one hand, we don’t want to see our loved ones suffer from needless pain, yet on the other hand, as professionals in the substance abuse field, we want to see all medications depoliticized and subject to the proper scientific process.

Much to the ire of legalization advocates – who banked on President Obama looking the other way while states voted to make an illegal drug medicine – the feds, working with state officials, have expanded its enforcement actions against commercialized “medical marijuana” operations. These operations market to kids, are tied to criminal organizations and their customers bear little resemblance to the truly sick and dying. There is no doubt that medical marijuana is a controversial and complex issue. I try to break down several of the more complicated issues, once and for all, in this two-part series.

Scheduling

In the wake of recent enforcement, the governors of Washington, Rhode Island and Colorado have filed a petition with the Drug Enforcement Administration (DEA) to reschedule marijuana¹. Specifically, the petition asks the DEA to reclassify marijuana from Schedule I to Schedule II of the federal Controlled Substances Act (CSA). The governors contend that such rescheduling will eliminate the conflict between state and federal law and enable states to establish a “regulated and safe system to supply legitimate patients who may need medical cannabis.”

Unfortunately, rescheduling, besides being an ill-advised move for several reasons, would not even solve the governors’ states’ problems. Under the CSA, a substance is scheduled into one of five classes – Schedule I means that it has no medical use, and high potential for abuse. The primary difference between Schedule I and II substances lies in the phrase “currently accepted medical use in the U.S.” This phrase has been interpreted to require that the drug’s chemistry is known and reproducible, that there are adequate studies on safety and efficacy, and that the drug must be accepted by qualified experts and backed up by widely available peer-reviewed science² (mere anecdotal evidence, state laws or even the policy positions of medical organizations, are not sufficient to satisfy these criteria). But placing marijuana in Schedule II alone, even if it were to pass that rigorous test, is not enough to get the governors out of their conundrum.

The big point is this: Schedule II substances may be prescribed by physicians and dispensed by pharmacists only when incorporated into specific FDA-approved products. This fact is sometimes articulated as follows: “Schedule II substances may be prescribed.” This abbreviated description, however, is dangerously incomplete and, as a result, has caused significant confusion. Such confusion underlies the governors’ current petition.

The FDA approves specific medical products produced by a particular “innovator” (for branded products) or generic manufacturers. For example, oxycodone, an opioid, is in Schedule II. Specific products, such as OxyContin® (an extended release form), are also in Schedule II. Physicians prescribe a specific branded or generic product, in a particular dose and dosage form. Smoked marijuana can’t be prescribed because there is no standardized dose and no specific product.

Imagine for a moment that the “medical marijuana” advocates were instead “medical opium” advocates and that various states passed laws legalizing the cultivation and distribution of opium plant material, i.e., opium latex or poppy straw. Even though opium latex and poppy straw are each in Schedule II, there would still be a conflict between such state laws and federal law. As a well-known drug reform advocacy website states: “If poppies are grown as sources for opiates, there is no question that it violates the CSA.”³ Furthermore, physicians would not be authorized to prescribe, nor pharmacists to dispense, dried opium or poppy straw. In order to be prescribed, a specific product containing opiate active ingredients (APIs) would have to pass muster in the FDA approval process. Therefore, the mere act of placing herbal marijuana in Schedule II would not make it available to patients nor address the conflict between state and federal law.

Other Issues

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.” Additionally, a committee of the California Medical Association recently called for the rescheduling of marijuana “so it can be tested and regulated.” In Part II, I will tackle these issues and more.

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 Ingold, J. (Dec. 29, 2011) “Colorado Asks DEA To Reschedule Marijuana.” Denver Post Accessed on January 20, 2012 at http://www.denverpost.com/news/marijuana/ci_19636149
2 See Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C.Cir. 1994); 57 F.R. 10499, 10506, 10507.
3 http://www.erowid.org/plants/poppy/poppy_law.shtml

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By Kevin A. Sabet

Published February 10, 2012

Exactly two weeks to the day I was born in 1979, Keith Stroup, the head of the National Organization of Marijuana Laws (NORML), told the Emory University school newspaper, The Emory Wheel, that “We are trying to get marijuana reclassified medically. If we do that, (we’ll do it in at least 20 states this year for chemotherapy patients) we’ll be using the issue as a red herring to give marijuana a good name.”

So it is no surprise that last week, NORML — the nation’s oldest marijuana legalization organization — published in their weekly newsletter the sweeping assertion that “medical marijuana has no discernible impact on marijuana use.” NORML cited a new article in the Annals of Epidemiology (a respected publication to be sure; a similar epidemiology journal will soon release a study showing that marijuana is significantly linked with car crashes) which critiques an earlier article by Wall and colleagues showing an increase in marijuana use among states with medical marijuana. Essentially, the authors replicated the Wall study using different methods and got different results.

Certainly medical marijuana is a complex issue — one where politics, compassion, ethics and science collide. Sixteen states and D.C. technically have laws allowing marijuana as medicine on the books, but these laws, like other drug laws, vary widely in implementation, so it is tough to even perform studies linking medical marijuana with use changes. NORML doesn’t seem too bothered by that. They went on to cite a Brown University study looking at Rhode Island — a state with a barely discernible medical marijuana program in the first place — as further “proof” that medical marijuana doesn’t impact use. And the usual folks, like Reason Online (I’m just waiting for Maia Szalavitz to get to this as well), essentially republished the NORML line without any critical analysis.

A closer look at these studies shows something a little different, and much more nuanced. First, they completely ignore the more thorough studies that in fact do show increases in use. A major study published in Drug and Alcohol Dependence by researchers at Columbia University looked at two separate datasets and found that residents of states with medical marijuana had marijuana abuse/dependence rates almost twice as high than states without such laws.

Most importantly, the studies discussed by NORML miss the mark, by failing to take into account the actual implementation of medical marijuana laws. For example, California did not have “dispensaries” until 2003, seven years after the law was enacted. And Rhode Island, the state used in the Brown study, had about 1,500 people in the entire program, so it’s not a revelation that the state would not see any significant effect on teens. Time will tell, with further study and analysis, how medical marijuana is affecting attitudes and use rates in the long term.

What of course is never talked about is how medical marijuana programs in states that have gone full steam ahead actually work. Rarely mentioned is the fact that, for example, according to a 2011 study in the Journal of Drug Policy Analysis that examined 1,655 applicants in California who sought a physician’s recommendation for medical marijuana, very few of those who sought a recommendation had cancer, HIV/AIDS, glaucoma, or multiple sclerosis. A study published in the Harm Reduction Journal (not exactly an anti-drug mouthpiece), analyzing over 3,000 “medical marijuana users in California, found that an overwhelming majority (87.9%) of those queried about the details of their marijuana initiation had tried it before the age of 19, and the average user was a 32-year-old white male. 74% of the Caucasians in the sample had used cocaine, and over 50% had used methamphetamine in their lifetime. Hardly any had life-threatening illnesses.

Finally, we know from other surveys like the University of Michigan Monitoring the Future study that the perceived harm for smoking marijuana occasionally or regularly has been decreasing among the 8th grade since 2007. Social disapproval for smoking marijuana once or twice, occasionally, and regularly has been decreasing among 8th graders since 2007. That has translated into a major increase in use, which is no surprise to researchers who know that attitudes effect youth use rates.

And how can we say that today’s medical marijuana programs aren’t having an effect on youth attitudes toward the drug? “Marijuana is medicine” has become a common slogan in America today, as people like Dr. Christian Thurstone, a Colorado doctor working with kids, recently talked about on National Public Radio.

It’s time to get the legalization lobby out of the business of medical marijuana and instead focus our attention on scientists developing non-smoked marijuana-based medications for the truly ill. That would make this issue no longer the sick joke that it is today.

Follow Kevin A. Sabet, Ph.D. on Twitter: www.twitter.com/kevinsabet

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By Reuters

Published February 7, 2012

SAN DIEGO, California (Reuters) – U.S. authorities are building a steel and concrete barrier 300 feet out into the Pacific Ocean south of San Diego to curb dangerous attempts by illegal immigrants and smugglers to slip through the breakers to California.

The new maritime fence is being built at a cost of $4.3 million at the point where the U.S.-Mexico border plunges into the ocean between San Diego and the industrial powerhouse of Tijuana, in northwest Mexico.

The new “surf fence” is a steel-and-concrete barrier up to 18 feet tall that replaces a rusted and uneven line of posts.

“It was falling apart, it was out of alignment, it looked like a bad set of teeth,” said Customs and Border Protection spokesman Ralph DeSio.

“This is going to be much more aesthetically appealing to that area, but it also strengthens our abilities to prevent those dangerous smuggling attempts along that shoreline,” he added.

Federal authorities in recent years have added fencing and Border Patrol agents along the southwest border with Mexico in a bid to stop illegal immigrant crossings and drug smuggling to the United States. Congress also mandated building a further 650 miles of fencing along the 2,000-mile border.

Recent attempts to slip north through the surf and inshore waters to Imperial Beach, south of San Diego, have included two smugglers nabbed with marijuana piled onto a surfboard in 2009, and a pair of wetsuit-clad illegal immigrants arrested last February with self-propelled underwater dive scooters.

Illegal immigrants from Mexico have also taken to the sea to swim around the existing rusted barrier and into Border Field State Park in southern California. One man drowned attempting the trip through the frigid waters last November.

The upgrade comes at a time when smugglers are also increasingly pushing further out sea in open-topped “panga” fishing boats to run illegal immigrants and tons of marijuana up the coast as far as the Los Angeles and Santa Barbara areas. There have been 14 incidents there since last October.

In a bid to make it more resilient to the pounding Pacific waves, the new barrier, which is due for completion in March, is coated with protectants inside and out, and is then being filled with concrete. It has an estimated life of up to 30 years, DeSio said.

The effort under way to ratchet up security at the beach, which includes a stretch of fencing that runs 900 feet inland, is raising some eyebrows in Tijuana.

Policeman Cesar Ochoa is struck by the transformation to Parque Amistad, or Friendship Park, just back from the beach, where families separated by the border would chat informally through the bars of the fence beside a historic monument. A double fence now walls off the area and prevents visitors from getting to within a few feet of each other.

“The only thing that remains from that time are the cement tables where people used to meet. There were Border Patrol agents watching over them … but they let people interact,” Ochoa said.

“After they started to increase surveillance because there were people who took advantage of those visits to slip into the United States illegally, which I suppose is why they cracked down on security,” he added.

Local government employee Adriana Medina, 33, remembers families picnicking and playing ball and even partying in the park when she was growing up and is surprised by the upgrade that pushed “steel posts right into the sea.”

“It looks like a jail,” she told Reuters. “I think it’s an overreaction.”

(Additional reporting by Lizbeth Diaz in Mexico City; Editing by Tim Gaynor and Daniel Trotta)

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