Showing posts with label recreational cannabis. Show all posts
Showing posts with label recreational cannabis. Show all posts

Saturday, October 8, 2022

Minnesota Medical Cannabis Program Petitions

 



I have written about this program in the past.  In Minnesota, we have a medical cannabis program that allows for the prescription of specific forms of cannabis for a list of what are seen as indications.  To get on that list is basically a review of opinions and the Commissioner. Even though this program runs like a mini-FDA, it does not have a standard for approving conditions for medical cannabis use.  And let’s face it - that is because the supporting evidence for using medical cannabis is very weak and in many if not most instances – non-existent. And as I have pointed out in the past – the evidence collected by the program is also weak.  As far as I know the program does not produce any detailed adverse drug effect information and a lot of that advice depends on the pharmacists dispensing the medical cannabis.

This year the conditions up for placement on the list of indications include opioid use disorder, obsessive compulsive disorder, and irritable bowel syndrome. I restricted my comments to the first two conditions and the rationale is very clear. In the case of opioid use disorder (OUD), it is a widespread drug epidemic at this point fueled by widespread availability of opioids and synthetic opioids. Even though physician prescriptions have decreased overdose deaths continue to increase on a year-to-year basis. The pattern of overdoses has also changed substantially since OUD has spread from metropolitan to rural areas. Thirty years ago, OUD and overdose deaths were practically unheard of in rural areas and now they are commonplace. There are effective treatment for OUD as listed in the letter that follows.  There is a problem with access to substance use disorder treatment.  Most states have practically no detoxification facilities.  Access to physicians who are prescribing medication assisted treatment (MAT) for OUD (MOUD) is also very limited.

Like most political movements in the country – there is no critical analysis of the various cannabis initiatives.  To me – it was obvious from the start that medical cannabis was a way to start building political consensus for legalization of cannabis. Adding more intoxicants to the environment is never a good idea – but the practical issue is that the lesson of alcohol prohibition was that it could not be done without increasing crime, corruption, and the health dangers of unregulated alcohol. So a medical cannabis initiative is really not a genuine attempt to treat medical conditions with cannabis.

On that basis – it is not surprising that there is significant overreach in finding conditions where medical cannabis can be used. OUD and OCD are just two more diagnoses on that list. I was informed that my comments will be added but the vast majority of comments are not by physicians and are basically testimonials to cannabis. The FDA receives a lot of criticism and they also elicit public commentary but there is a core body of scientific decision makers.

With the writing of this post President Biden just came out with a statement that he is going to pardon people who are incarcerated for simple possession of marijuana and encourage governors to do the same (1).  That may be easier said than done since there was also a news report that the majority of these people have additional complicating charges.  He also initiated a review process by Secretary of Health and Human Services and the Attorney General on the way marijuana is listed in the Control Substance Act schedule.  It is currently a Schedule I drug making it the most dangerous and without medical applications according to this ranking. That results in a large grey zone when it is legally prescribed in some states and approved for recreation use in others.  There are associated problems with banking due to the federal scheduling but in an election year when any number of people from both parties are tripping over each other to legalize it – it seems like a foregone conclusion that it will be rescheduled at the minimum.

The Minnesota legislature approved low dose cannabis edibles earlier this year. There is a question about whether that was done by mistake. This is another step toward the eventual legalization of cannabis in Minnesota and will probably lead to the extinction of the Medical Cannabis program.  This story also illustrates the confusion among legislators about the basic differences between raw materials and cannabinoid derivatives. My viewpoint is legalization of cannabis was the goal all along and the users of medical cannabis have objected to higher fees for the medical product and many prefer smoking cannabis rather than using other forms.

 

George Dawson, MD, DFAPA

 

1:  Statement from President Biden on Marijuana Reform October 7, 2022 Link.

2:  Miranda S.  Minnesota lawmakers voted to legalize THC edibles. Some did it accidentally.  July 2, 2022 Link.


The letter not in support of indications for opioid use disorder or obsessive compulsive disorder:

October 3, 2022

Office of Medical Cannabis
PO Box 64882
St. Paul, MN 55164-0882

To Whom It May Concern:

I am a Minnesota psychiatrist who recently retired from clinical practice. I continue to research and write about psychiatry.  I worked at one of the largest substance use disorder treatment facilities in the United States. Every person I saw had a substance use disorder (SUD) that was significant enough to need residential treatment. Alcohol use disorder was the most common followed by opioid use disorder (OUD).  I was also an adjunct professor and lectured on the epidemiology, assessment, and treatment of substance use disorders. Areas of focus included the neurobiology of SUD, opioid use disorders, chronic pain, and Attention Deficit~Hyperactivity Disorder. I did research on medication assisted treatment of alcohol use disorder and depression. 

As an SUD develops, there are several associated biases that lead to chronicity. The first is the euphorigenic effect or “high” that occurs with all substances. That becomes a permanent memory that all subsequent episodes of use are compared against. Tolerance to drug effects limits the ability to experience that same degree of euphoria.  That leads to attempts to use more or more powerful versions of the same drug. In the case of OUD, that has led to the use of more powerful opioids like fentanyl. A second bias is the idea that all emotions and reactions to stress can be controlled by external substances.  Cannabis, alcohol, and benzodiazepines are used for that purpose. In that situation, withdrawal symptoms are misinterpreted as anxiety or depression.   That leads to an additional substance being taken. Detoxification is required to determine a person’s baseline state and whether there is a treatable anxiety or depressive disorder. A third bias is that “I have a lot of time to quit.” Young people with severe SUD will often tell themselves: “I am only in my 20s, I can quit later and at that time go to work or school.” That prolongs their risk exposure and the associated morbidity and mortality. A fourth bias is people with SUD are not risk averse. In other words, if they knew a substance contained fentanyl and were risk averse, they would avoid it. This is not true. Many will seek out fentanyl products or products they know contain fentanyl in pursuit of getting high. That pursuit can get to the point that greater amounts of substances or more novel substances are used and they do not care what the outcome is. They are willing to risk a fatal outcome in pursuit of getting high.  Finally, withdrawal symptoms from substances create a negative reinforcement bias – substances need to be taken to avoid withdrawal symptoms.

Easy access to opioids is a major factor in the continuing opioid crisis and the “three waves” of this epidemic that are described by the CDC (1). There were several papers (3) published that suggested that medical cannabis use was associated with less opioid use. Those findings have not been validated over time.   There has been a study done showing that opioid use was more likely to increase rather than decrease (4) with cannabis use. That study is consistent with what I have seen in the clinic.  

To summarize:

1.  We are still in the midst of a 2 decades long opioid use epidemic that has produced significant overdose mortality and morbidity. 

2.  There are current FDA approved treatments (10 drugs in 3 categories) that have demonstrated ability to prevent opioid overdoses and treat opioid use disorder (2). 

3.  Suggesting that Minnesota residents with an opioid use disorder use cannabis with no proven treatment efficacy over the FDA approved medications that have efficacy presents a clear ethical problem considering the level of mortality associated with this disorder.

For these reasons medical cannabis should not be approved for opioid use disorder.

I am also recommending that medical cannabis not be approved for the treatment of obsessive-compulsive disorder. The bulk of my argument rests on the information that I submitted last year recommending no medical cannabis approval for generalized anxiety disorder. In that submission, I pointed out that for many people cannabis use leads to anxiety and panic attacks rather than alleviating them. Obsessive-compulsive disorder (OCD) has effective psychotherapies and medical therapies. In fact, psychotherapy is the primary treatment modality. We currently have a healthcare system that rations access to both psychotherapy and medical treatment. When the lack of clinical trials of cannabis in OCD is considered, the same ethical dilemma presents as in the case of opioid use disorder. Is cannabis approved for OCD because health care systems and government regulators refuse to provide access to proven methods of treatment?

In both the case of opioid use disorder and obsessive-compulsive disorder, neither should be an indication for medical cannabis for the above stated reasons.

Sincerely,

George Dawson, MD, DFAPA

Lino Lakes, MN

 

 

References:

1:  CDC.  Understanding the Epidemic:

https://www.cdc.gov/opioids/basics/epidemic.html

 

2:  FDA Information about Medication-Assisted Treatment (MAT):  https://www.fda.gov/drugs/information-drug-class/information-about-medication-assisted-treatment-mat

3. Bachhuber MA, Saloner B, Cunningham CO, et al. Medical cannabis laws and opioid analgesic overdose mortality in the United States, 1999–2010. JAMA Intern Med. 2014;174:1668–1673.

4:  Olfson M, Wall MM, Liu SM, Blanco C. Cannabis Use and Risk of Prescription Opioid Use Disorder in the United States. Am J Psychiatry. 2018 Jan 1;175(1):47-53. doi: 10.1176/appi.ajp.2017.17040413. Epub 2017 Sep 26.

 


Sunday, March 10, 2019

Will Physicians Be Superfluous In The Recreational Cannabis World?




When it comes to advising people to use cannabis for various problems I think the answer is yes.    Only a small fraction of people who can access recreational cannabis will be asking physicians for advice on using these products. There are a confluence of reasons but basically they involve cultural factors, political factors, the marketing of cannabis products, expense, and the inconvenience of seeing a doctor for advice and prescriptions when you can get advice from other people including dealers and producers.  I would go as far as saying that many of the advisors will be prominent media figures giving advice on the use of cannabis and expanding the marketplace.  It follows that the education of physicians should take these factors into account.

It is easy to get into disagreements on Twitter.  I think most physicians including myself are fairly easy to disagree with because we are not invested in “winning” an argument. As a psychiatrist I know that I certainly am not going to win against an ideologue or somebody was interested in calling me names. This week I got into a disagreement about the role of physicians in medical cannabis. The controversy was sparked by an article written by a medical student about why medical cannabis should be discussed in medical schools.  Any reader of this blog knows that my position has been that medical cannabis is basically a political lever to promote the widespread legalization of so-called recreational marijuana. I also believe that every state in the United States will eventually have recreational marijuana. I don't argue that point - I know it will happen.  At that point, we will have a better assessment of the risks involved with this policy and they will be significant.

The issue this week was a post suggesting that medical students and physicians should have more training in “medical cannabis”. My position was that if most states go the way that Colorado went physicians will be entirely superfluous in that process. It comes from my knowledge of interaction of American culture and the wide availability of recreational cannabis products in the state of Colorado. Medications especially those that are self-reinforcing or put more basically the ones that can get you high, attain mythical status in the American culture.  Practically everyone I know hoards opioids.  That supply of oxycodone or hydrocodone that is typically given for some type of injury used to be held onto for years. Neighbors would trade pills back and forth over the fence. Opioids no longer sit in a medicine cabinet for years as people actively seek out opioids to get high or sell.  Most Americans have a set idea of what opioids they would like for pain and that decision-making process is complex based on their experience and also what they’ve heard from other people.  The reality of that process is quite different.

In my opinion pain has been inadequately studied and continues to be inadequately studied. The concept of “self-medication” is at the top of that list. I usually hear about it in the form of this sentence:

“Look Doc, if you can’t get rid of this (anxiety, depression, insomnia, pain, fatigue, distractability) I know how to get rid of it for at least four hours.”

When I inquire about the method it invariably comes back to alcohol or some type of consciousness altering drug. I use the term consciousness altering because the drugs used are not necessarily addictive. A good example is a combination of antihistamines and muscle relaxants to cause a state of delirium and sedation. Alcohol is frequently used as a way to address chronic pain. The medical cannabis initiative basically started around the issue of chronic pain and terminal pain. From there it has expanded indications in those states that list their own like Colorado and Minnesota. A lot of people address the issue of chronic pain by altering their conscious state. I certainly have no problem with that in certain circumstances but it is a major unaddressed dimension in the treatment of chronic pain.

The American Society of Addiction Medicine (ASAM) has a lengthy position statement (1) on the physician’s role in medical cannabis. They review the need for scientific study and a regulatory process that will provide pure and consistent formulations from companies in a similar manner to the pharmaceutical industry. It is the only way to come up with standardized dosing for specific conditions.  The only problem I have with that statement is that it is fairly naive to think that people with a choice between purchasing high cost pharmaceutical grade medical cannabis and recreational cannabis that claims to have the same cannabinoid content will choose the former whether it is “prescribed” or not.

That leads me to what I see as the role for physicians in a society that has widespread availability of recreational cannabis. Colorado is a good case in point. Looking at what cannabinoid products are available in a Colorado gas station, it is hard to imagine that people will be consulting physicians for what products to use. I recently found a web site for Colorado gas station cannabis with a wide range of smokable and edible cannabis products.  The edible products contained up to 250 mg THC per bar.  Physicians currently have the role of certifying conditions for people who will get access to medical cannabis. In Minnesota advice about medical cannabis comes from the pharmacists dispensing it and not from physicians. There is widespread advice available on the Internet about how any interested user could start using cannabis.

All of these factors, lead me to conclude that there will be a very limited role for physicians in recommending cannabis or prescribing it. There have been limited medical studies of cannabis and limited indications. There are basically two FDA approved applications and even those medications will be obsolete when people have access to the recreational and less expensive forms. There is no logic at all to declaring a botanical product is on the one hand “medical” and on the other hand “recreational”.

A larger role for physicians will be in the treatment of the medical complications from cannabis and people who become addicted to it.  As millions and millions of people start using legal cannabis – the number of people addicted to it will also increase.

The best way to address cannabis in a medical school curriculum doesn’t require an extensive course in medical cannabis for an ever-increasing political list of indications.  It should not teach medical students that they are going to have a central role in the acquisition and prescription of cannabis.  It can be done in the following courses:

1.  Basic science: neuroanatomy and neurophysiology – the endocannabinoid system’s critical role in basic physiology and clinical correlations.

2.  Basic science: pharmacology – detailed pharmacology of cannabinoids.

3.  Addiction course- there needs to be a basic 2-week course added to the medical school curriculum on addiction and the prescription of drugs that reinforce their own use with necessary risk mitigation techniques.  Many medical schools have a 6-week course in psychiatry that is usually based on an inpatient unit.  I recommend adding two weeks to that with experience in an addiction clinic. I currently work in a program where we provide two week training programs to residents, medical students, and physicians for this purpose.

4.  Elective course - experience in specialty programs where there may be more cannabinoid use (pain clinics, palliative care, toxicology) that can be tailored to a student’s interest.

5.  Clear identification of resources for further study - during lectures I always mention the major addiction texts and their organization. Additional state-of-the art references could be posted in a self study syllabus - primarily because a clinical focus would not allow enough time to cover the necessary basic science.

6.  Advice on the regulatory burden - in the foreseeable future that means familiarity with the statutes and regulations in each state.  Medical schools generally do not teach these practical aspects of medical care.  States recognize that physicians can't prescribe a CSA Schedule 1 drug, and limit the physicians role to certifying the conditions that qualify the patient for medical cannabis. Some states require physicians to get approval for that role.  That seems like overkill to me. Any medical record with the qualifying condition listed should lead to certification and would probably be more objective. 

Any effort beyond what I have listed above is probably unrealistic based on the fact that this is (along with supervised practice) is the basic approach to any medication that physicians prescribe.  I am not aware of any medical school initiatives to intensify the training for opioids, benzodiazepines, or stimulants but would appreciate hearing about any of those courses. In the course where I teach, we see medical students, residents, and physicians from all over the US and Canada.

In closing are there possibly ways where physicians will end up in a more central role? Only if the FDA and other regulatory bodies put them there.  For example, in my post on Epidiolex I asked about the patentability of CBD products, specifically this one that was an extraction product of cannabis.  Physicians prescribing these FDA products need to learn to prescribe them like any new product, but is there a chance that FDA approved and patented cannabis products are a threat to the products available for recreational and medical use from dispensaries?  There is currently a story circulating saying that the FDA is going to ban all CBD oil use except for Epidiolex and it will cost all users $32, 500 a year. That would favor the pharmaceutical industry but I don't think that will happen. It is more likely that other products designed to affect the endocannabinoid system will be developed like standard pharmaceuticals and that will lead to physician prescribing - if there is anyone left at that point who is not using recreational cannabis.



George Dawson, MD, DFAPA




Supplementary Information:

I recently encountered an interesting twist by a cannabis advocate in a state where recreational cannabis is not yet legal and medical cannabis is strictly controlled as non-smokable products.  He argued that the terms recreational cannabis and medical cannabis should be changed to cannabis for non-prescription and prescription use.  He argued that this would normalize the political process since nobody designates alcohol as recreational or medical. The obvious reason is that alcohol has extremely limited roles as a medication.  The term medical cannabis may have lost some of its luster as a politically correct approach.    




References:

1:  The Role of the Physician in “Medical” Marijuana. ASAM Public Policy Statement (2010) Link


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