Minnesota Passes Medical Marijuana "Research" Bill

It's official.  Both houses of the Minnesota legislature passed a medical marijuana bill last Friday night.  The Governor has already said that he would sign it.  Minnesota ended up taking a unique approach largely because the Governor said he would sign no bill that was not accepted by law enforcement.  The process was also affected by the medical society who did not want physicians in the prescribing loop and the psychiatric society who did not want psychiatric disorders used as an indication for marijuana.

That effectively took marijuana smoking off the table.  The turning point was apparently young mothers testifying that cannabis derivatives were critical to the treatment of refractory epilepsy.  At that point there were several new drafts of the bill looking at the indications, the physicians role, and the role of the government.  The agreed upon indications follow:


Subd. 14. Qualifying medical condition. "Qualifying medical condition" means a
3.15diagnosis of any of the following conditions:
3.16(1) cancer, if the underlying condition or treatment produces one or more of the
3.17following:
3.18(i) severe or chronic pain;
3.19(ii) nausea or severe vomiting; or
3.20(iii) cachexia or severe wasting;
3.21(2) glaucoma;
3.22(3) human immunodeficiency virus or acquired immune deficiency syndrome;
3.23(4) Tourette's syndrome;
3.24(5) amyotrophic lateral sclerosis;
3.25(6) seizures, including those characteristic of epilepsy;
3.26(7) severe and persistent muscle spasms, including those characteristic of multiple
3.27sclerosis;
3.28(8) Crohn's disease;
3.29(9) terminal illness, with a probable life expectancy of under one year, if the illness
3.30or its treatment produces one or more of the following:
3.31(i) severe or chronic pain;
3.32(ii) nausea or severe vomiting; or
3.33(iii) cachexia or severe wasting; or
3.34(10) any other medical condition or its treatment approved by the commissioner.

A couple of issues about the statutory conditions.  First of all, a patient wanting to use cannabis for any of these conditions needs to be certified that they have the conditions.  That is not the same as a medical diagnosis.  Each patient will need to apply to the Department of Health for the certification and that will cost $200.  Physicians are not necessary for the patient to be certified.  Anyone certified and any physician who wants to be involved will be monitored in a registry through the Department of Health.  It is also obvious from the list, that for the conditions, there is really no known medical indication for cannabis.  An excellent example is glaucoma and the review of the pathophysiology and treatment for glaucoma for primary care doctors in this week's JAMA.  Finally, the entire system is going to be implemented as a research program with no controls and (so far) no known research methodology.

The newspaper headline touches on one of the main issues and that is the cannabis will not be smoked.  There was an initial consideration that vaporizers could be used in a physicians office under the supervision of a physician.  That restriction was not in the final bill.   The Commissioner of Health is charged with providing people certified for the following conditions with medical cannabis by July 1, 2015.  In the conference I attended today, there will apparently be competition for two suppliers to provide medical cannabis at 4 outlets each in the state.  Medical cannabis is defined as:

 (e) "Medical cannabis" means the flowers of any species of the genus cannabis plant,
1.20 or any mixture or preparation of them, including extracts and resins which contain a
1.21 chemical composition determined to likely be medically beneficial by the commissioner,
1.22 and that is delivered in the form of:
1.23 (1) liquid, including, but not limited to, oil;
1.24 (2) pill;
2.1 (3) vaporized delivery method with use of liquid or oil but which does not require
2.2 the use of dried leaves or plant form; or
2.3 (4) any other method approved by the commissioner but which shall not include
2.4 smoking.

That last two lines were were surprising, but law enforcement in Minnesota was apparently not on board with legalizing marijuana smoking.  Given the momentum of the marijuana movement at the national level, that was surprising to see in what is considered a liberal state.  The psychiatric society also gets credit for removing Post Traumatic Stress Disorder, from the list of qualifying medical conditions and providing the governor with a rationale to continue negotiating.

The Commissioner is also charged with reviewing the literature on medical cannabis, suggesting doses and additional qualifying medical conditions, and maintaining a registry of the effects of medical cannabis on the target condition.  That aspect of the law seems like a black hole to me, because it means that the Health Department will essentially be providing FDA services on an experimental medication.  What state department of health can pull that off?  The trials will all apparently be observational studies since no group of people wanted to be control subjects.  They apparently have no doubt that cannabis is an effective drug for what ails you.  Since cannabis has been used by humans since the Neolithic Era (4,000-2,500 BCE) and medicinally in many contexts since then, it is always interesting to consider why nobody has not found a consistent medical use in the past 5,000 years.

The Minnesota law is an interesting approach and I think it may be an excellent compromise.  It gets cannabis to the severely ill who claim benefits while avoiding the issue of recreational use.  This is also an an analogous approach currently used in the case of terminally ill patients and getting them access to experimental therapeutics.  According to speaker I was listening to yesterday the case presented by mothers of children with intractable seizures provided some of the most  compelling testimony.

The passage of this law also dovetails with the editorial in Science this week.  DuPont and Lieberman make the case that adolescent exposure to cannabis should be expected by any legalization and the long term effects on that population are really unknown, but that the preliminary evidence in terms of future risk of addiction or psychiatric disorders does not look good so far.  That same issue of Science has an interesting article on neurogenesis in the dentate gyrus at various points in the life cycle of mice pointing out that learning and retention requires a delicate balance in just the right amount of neurogenesis.  Preliminary research suggests that cannabis affects neurogenesis.

I don't often agree with the politicians of either party, but this may be the best compromise available during a cultural trend of increased permissiveness toward drug use.  The main problem with the bill is putting the Department of Health in a regulatory role that may be difficult for them to realize without a significant increase in budget and manpower.  It also makes cannabis seem to be a legitimate medical treatment - when it is not.


George Dawson, MD


References:

1.  Mike Cronin.  Minnesota Senate passes medical marijuana bill; could become only state that bans smoking.  Minneapolis StarTribune May 17, 2014.

2.  Information for S. F. No. 2470

3.  Weinreb RN, Aung T, Medeiros FA. The pathophysiology and treatment of glaucoma: a review. JAMA. 2014 May 14;311(18):1901-11. doi: 10.1001/jama.2014.3192. PubMed PMID: 24825645.

4.  Mongiat LA, Schinder AF. Neuroscience. A price to pay for adult neurogenesis.  Science. 2014 May 9;344(6184):594-5. doi: 10.1126/science.1254236. PubMed PMID: 24812393.

5.  Akers KG, Martinez-Canabal A, Restivo L, Yiu AP, De Cristofaro A, Hsiang HL, Wheeler AL, Guskjolen A, Niibori Y, Shoji H, Ohira K, Richards BA, Miyakawa T, Josselyn SA, Frankland PW. Hippocampal neurogenesis regulates forgetting during adulthood and infancy. Science. 2014 May 9;344(6184):598-602. doi: 10.1126/science.1248903. PubMed PMID: 24812394.

Some Arguments on Drug Tolerance and Prohibition

I have extensive experience treating people with alcohol and drug use problems.  I am always amazed at the lack of knowledge about addiction and alcoholism in the general public and how that impacts public policy.  As a result I occasionally get involved in public forums to argue a few points.  As a matter of disclosure I am thoroughly independent and vowed not to vote for any major party candidates a long time ago.  That doesn't prevent people from sending me heated e-mails accusing me of either being a Democrat or a Republican.  Of course you can also be attacked for being a independent and being too much of an elitist to not accept the fact that only major party candidates can be elected.  I have never found that to be a compelling argument.  My latest post to the quoted excerpt follows.  You can read the entire sequence of posts by clicking the link at the bottom.  There are obvious limitations to engaging in this exercise and that should be evident by reading the exchange right up to the last post where I get the expected shot for being a psychiatrist.  Tiresome isn't it?

“Come again...Politicians are pushing for legalization?  Politicians have been spewing the “war on drugs” “tough on crime” protecting the “fabric of society” bullshit for the last 40-plus years.”

Sorry – I try just to stay to the facts.  If you read the actual history of drug use in this country we swing from periods of prohibition to drug tolerance.  We are currently swinging into a period of drug tolerance and I fully expect to see drugs legalized in some way or another in most states.  So I really don’t have a stake in this fight either way.  So you can lighten up.  I am not “on your side” but I can predict with certainty that it will happen.  You can Google “politicians who support drug legalization” as well as I can.  As more of them get on board you will hear an escalation in rhetoric on how they will tax and control it.

You can put any type of spin on it you want – more freedom, freedom from the war on drugs, ability to generate more taxes, ability to treat any problem you might have with medical marijuana, you name it – history shows the outcome will be the same.  If you are still serious about legalizing heroin and coca like you previously stated that experiment has already been done and the outcome will be the same.  That experiment is being done right now with diverted legal opioids (the source of synthetic heroin) and according to the CDC we are in about year ten of an opioid epidemic that is killing more people in many states than motor vehicle accidents – about 15,000 people a year.  If you consider that the drugs typically called synthetic heroin on the street are usually pharmaceuticals with known safe doses, that also illustrates the nature of the problem.  If you think that nobody will be looking for synthetic marijuana if marijuana is legalized – I know that is false per my previous post.  No matter how free you are to smoke marijuana, there are very few employers I know of that will tolerate it at work and none if you are in a job where your decision making can lead to substantial liability. 

The problem with the “war on drugs” and excessive incarceration of people with drug charges in many ways parallels the excessive incarceration of the mentally ill because we have a health care system that is politically managed.  The politicians realized a long time ago that you can save health care costs by incarcerating the mentally ill instead of treating them in medical settings.  It may not have been a conscious decision up front but they have done little to stop it after it was clearly underway.  The three largest mental hospitals in the US right now are county jails.  Addicts in many cases are treated even more poorly if they are incarcerated because they do not get medically supervised detoxification and go through acute withdrawal.

In any “war” somebody has to be blamed and denied resources.  I prefer Musto’s analysis of the US tending to blame other countries for our drug problems:  “That analysis avoids the painful and awkward realization that the use of dangerous drugs may be an integral part of American society.”  That is reminiscent of Mexico’s Past President Vincente Fox pointing out that Mexico’s problem with cartel violence is fueled by America’s massive appetite for drugs supplying the money.  On that basis he was a proponent of the legalization and control of marijuana argument.  That doesn’t address the massive appetite for drugs problem.

The problem with the politics of addictive drugs is that people generally don’t know much about addiction.  There is a significant portion of the population that is vulnerable and the only thing it takes in increased availability for them to start having significant problems.

So good luck with the new temporary American dream of increased access to intoxicants and enjoy it while you can.  Depending on exactly what gets legalized – I would predict that would be the next 20 – 40 years.  That is the usual time it takes to complete a cycle.

Minnesota Politics and Issues Forum

George Dawson, MD, DFAPA

David F. Musto.  The American Disease: Origins of Narcotic Control.  Third Edition.  New York, Oxford University Press, 1999: p 298.  

Additional Clinical Note 1: A couple of graphs from my other blog that show alcohol use patterns over time are available on my other blog for the United States and the United Kingdom.  Graphs of opioid consumption over the past decade by the UN drug control agency shows a linear increase in consumption and production.

Additional Clinical Note 2:  If you had the patience to follow the political thread you probably notice the marijuana advocate trying to tell me that I was saying there was an epidemic of synthetic marijuana abuse that occurred with the legalization of marijuana.  My argument was simply that marijuana users if they are screened for THC at work will switch to synthetic marijuana in order to avoid positive toxicology screens and job loss.  Now in the February 5, 2014 edition of JAMA a report from the CDC it turns out that there was an "outbreak" of synthetic marijuana use in Colorado in August and September that involved about 200 people.  There was a similar outbreak in Georgia in August of 2013.  In addition  to the medical characteristics I would encourage the CDC to collect data on how many people were smoking marijuana to avoid toxicology testing and how many people were unable to stop smoking marijuana in order to achieve that same goal. I sent the CDC a note on how to refine their methodology. 

Supplementary Material Note 1:  My response from the CDC.

The Selling of Medical Marijuana

I have been thinking about how to approach this topic for a while.  My experience is not the experience of most people because as a psychiatrist I am seeing some of the worst possible outcomes.  That usually involves psychotic symptoms, depression, severe anxiety and panic, paranoia or some combination of all of these symptoms.  I have seen a much larger group of people who stopped on their own, usually after getting paranoid or experiencing a panic attack.  A lot of people cannot stop smoking even when they have a clear medical problem.  In some cases they are using marijuana or some cannabinoid product for a specific medical problem despite the fact that they are not getting relief and I would not expect them to.  These folks are typically heavy smokers (blunts, spliffs, vaporizers) but like all pharmacologically active compounds the dose response curve is highly variable.  

The  epidemiology of major symptoms caused by cannabis use has become a lot clearer in the past 10 years.  Thirty years ago there was an isolated study showing that army conscripts who were marijuana smokers were more likely to develop schizophrenia.  There was also a prominent researcher at the time suggesting that populations where there were high levels of cannabis use did not have higher rates of psychosis.  But those populations did not have high quality epidemiological data.  The latest studies show significant increases in the likelihood of schizophrenia and mood disorders.  I think that this probably happens in a minority of people and probably those consuming the most THC.  There is a lot of discussion about the differences in THC content of marijuana in the 1970s relative to what it is now, but not much reliable data to back that up.  Since THC is a pharmacologically active molecule with known pharmacokinetic properties it is always a question of dose as well as potency.  Multiple doses will eventually get you to the same levels of fewer doses of a more potent product.  he need to avoid positive urine toxicologies for THC also drives the market in synthetic cannabinoids, since the word on the street is that taking these drugs does not result in a positive toxicology screen and jeopardize employment.

A recent public opinion poll shows (click  to enlarge).  The recent trend to legalize comes in the context of an increasing trend about using marijuana and other controlled substances for legitimate medical purposes and media portrayals of marijuana as a source of employment, entertainment, and alternative medicine.

There is not the same level of skepticism about marijuana as there is about psychiatric medications.  In that case, the drugs are approved as safe and efficacious by regulatory bodies.  There is no evidence that they cause problems at anywhere near the level of marijuana and yet the latter is generally given a bye in the media.  Incredibly, many states get around the legalization of a scheduled drug by making it a "medically necessary" substance.  In spite of the fact that cannabis has been around for over 850 years and tens of thousands newer medications were invented and used successfully, the myth that cannabinoids are necessary as a medication has been promulgated in an apparent effort to increase the legalization of this substance.  The Obama administration has taken a public stand on the medical marijuana issue saying that the state statutes stand, but that they will engage in a selective prosecution that targets organized and violent crime, especially if that crime involves children or increased access to firearms.

I think that medical marijuana is generally a concept that has little to do with medicine and more to do with the legalization of marijuana.  It would become much more obvious if there were exposes in the press about how prescriptions for medical marijuana actually work.  What has to be said in the interview to get the prescriptions and what are the incentives of these prescribers?  We have had a fairly constant barrage of criticism of psychiatrists prescribing non-addicting drugs to patients for legitimate FDA approved indications that are in aggregate safer than cannabinoids.  Where are the questions about an industry that is selling a potentially addictive drug that has no clear medical indication and the potential conflict of interest of the prescribers?  I certainly have no problem continuing to advise all my patients with, anxiety, mood, addictive, and psychotic disorders that they need to not use marijuana at all, despite the fact that they are getting advice that marijuana is good for anxiety, depression, and insomnia.  I also have no problem telling anyone who might want a medical marijuana prescription that medical marijuana is a political term that has nothing to do with the practice of medicine and as such - I am not a "prescriber".

The other physician dimension to this issue is overprescribing.  The current epidemic of prescription opioid use and resulting accidental overdose deaths is a good example.  Unlike marijuana, the opioids have clear indications for use and contraindications.  In aggregate, marijuana probably has a wider safety margin, but the prescribing dynamic is similar to opioids and antibiotics.  The physician is confronted with a highly motivated patient who wants to leave the office with a prescription and physicians have have varying levels of motivation and skill to deny a wanted but unnecessary prescription.

I have no problem with any state declaring marijuana or any cannabinoids legal for its residents to line up and purchase.  Although marijuana promoters always give the message that it is safer than alcohol, it has the same general parameters  of use and no real medical indication.  I do have a problem with involving medicine in an experiment to legitimize it for just about anything.  I also think that physicians should know better.  We ran similar experiments for drugs with clear medical indications like opioids in the past century and they did not turn out well.

George Dawson, MD, DFAPA

American Society of Addiction Medicine (ASAM):  ASAM Medical Marijuana Task Force White Paper.

Joseph Lee, MD on Marijuana Legalization and the Impact on Children and Adolescents.

Dr. Oz addendum:

An example about the type of information the public gets from the media can't get any better than this Dr. Oz episode "Is Weed Addictive?" on December 4, 2913.  The full details are not really provided at this time.  I saw a debate and one of the participants was Pamela Riggs, MD who provided standard information on the addictive properties of marijuana.

Dr. Oz posts additional comments on his blog and seems to confuse the issues of addiction, legalization, and medical use.  After talking how it is going to be widely available he concludes:

"As the trend towards legalizing this drug continues, we need to be aware of its risks and teach our children its proper place, which is in the pharmacy, not in the kitchen cabinet and certainly not in the school locker."

So it will be more widely legalized as a pharmaceutical that people will use that way?

I will post additional details of this broadcast as they become available.