Government Regulations Impeding Medical Research: Damaging Breakthrough Psychological Advancements

During the 1970s, government officials created strict laws against the sale, use, and possession of recreational drugs, such as, LSD (lysergic acid diethylamide), Psilocybin, MDMA (3,4-Methyl​enedioxy​methamphetamine), and, Ketamine. In 1970, government officials passed the Controlled Substance Law (CSL) in efforts to restrict the sale or possession of substances deemed as ‘dangerous’ to general exposure, as congress enacted the Controlled Substances Act (CSA), which categorizes recreational substances into different ‘schedules’ depending on their potential for abuse, ranging from high (Schedule I) to low (Schedule V) potential of abuse and/or dependency (“Controlled Substances Act.” 2019. Wikimedia Foundation.). These strict regulations were the end result of the counterculture that arose in the sixties; in the beginning of 1965, the excitement surrounding these new drugs quickly caused moral panic, that by the end of the decade, psychedelics were outlawed and forced to go underground (Pollan Introduction. 2018. Pp 3).

In recent decades, researchers have reexamined an alternative form of treatment for individuals diagnosed with mental disorders, like, anxiety disorders, depressive disorders, addictive disorders, e.g., alcoholism (Pollan. Introduction. 2018. Pp 3). This new alternative treatment involves a trained-professional, usually a researcher, administering participants with regulated doses of illegal substances while they undergo different forms of therapy. Scientists claim this new form of treatment could potentially be more beneficial than traditional prescription medications, because, results from clinical trials show participants having positive responses to this breakthrough medical research (Nutt. 13.1., (2015): Web). For example, studies administering regulated doses (between 0.2 to 1.7 mg) of MDMA combined with different forms of psychotherapy have had very positive results; results showing the increase of dopamine, serotonin, and, endorphins neurotransmitter with being in a safe and supportive environment, can extinguish the fear associated in traumatic events that cause PTSD (Feduccia and Mithoefer.  2018. Elsevier). Drug regulations, like, the CSA and the CSL, cause clinical trials, using Schedule I drugs, to be delayed or completely stopped, and researchers do not have the time, money, or energy to face these regulatory hurdles, which makes research impossible to conduct (Nutt. 13.1., (2015): Web).

Laws and regulations that oppose using illegal substances in medical research should to be reformed, because, the information creating these regulations is outdated and discredited by recent information revealed about illegal substances (Nutt. 13.1., (2015): Web). Government officials created a flawed system, i.e., the scheduling system, and, these regulations are impeding breakthrough medical research that could potentially be a long-term treatment for certain psychological disorders (Pollan. Introduction. 2018. Pp 3). Author of The Drug Wars in America, 1940-1973, Kathleen Frydl, states “the legislation was not a scientifically arbitrated scheme of drugs, but a political framework that consolidated a host of decisions, as well as some failures, to decide how to manage the drug portfolio of the United States”; in other words, these regulations are causing more harm to society than good.

 

I decided to share this TEDtalk to farther explain why changing these government regulations benefit society. The video below is a TEDtalk, led by, David Nutt, explaining how government policies are unjust and failing the younger generations:

 

Cited Sources:

“Controlled Substances Act.” Wikipedia. 29 Mar. 2019. Wikimedia Foundation. <https://en.wikipedia.org/wiki/Controlled_Substances_Act.>

Pollan, Michael. Whole Book. How To Change Your Mind: What The New Science Of Psychedelics Teaches Us About Consciousness, Dying, etc. New York: Penguin Books, 2018.

Nutt, David. “Illegal Drugs Laws: Clearing a 50-Year-Old Obstacle to Research.” 13.1 (2015): E1002047. Web.

Feduccia, Allison A., and Michael C. Mithoefer. “MDMA-assisted psychotherapy for PTSD: Are memory reconsolidation and fear extinction underlying mechanisms?” Progress in Neuro-Psychopharmacology and Biological Psychiatry. 07 Mar. 2018. Elsevier.  <https://www.sciencedirect.com/science/article/pii/S0278584617308655>

Frydl, Kathleen J. The Drug Wars in America, 1940–1973. Cambridge University Press, 2013

 

Video:

How government policy fails young people. Dir. TEDx Talks. Perf. David Nutt. YouTube. 03 Dec. 2013. <https://youtu.be/lSQD_zaLtks>.

 

Government Regulation on Research Studies Using Illegal Drugs

Throughout the research I’ve collected on the use of illegal drugs in research studies and the effectiveness of these drugs as a form of long-term treatment for different mental illnesses, each study has shared a common theme. Researchers have either delayed or completely stopped their clinical trials because of government regulations on illegal drugs, mainly Schedule 1 drugs (Nutt, David. 13.1 (2015): E1002047. Web). These laws controlling the public’s exposure to illegal drugs are based on the UN Single Convention on Narcotic Drugs (1961) and the Convention on Psychotropic Substances (1971); they define a range of substances that are sufficiently harmful to the general public to be removed from usual sale regulations (Nutt, David. 13.1 (2015): E1002047. Web). These conventions were held in the 1960s-1970s, thus making the information from these conventions ‘out-dated’,  this is due to the vase medical and technological advances that have come out in the past forty years. The drug regulations that came from these two conventions continues to cause problems for researchers because, first-off, the government is banning certain medicines that could beneficial for their clinical trials, and second, current regulations are limiting the investigations (research studies) behind the potential medical use of illegal substances (e.g. LSD, psilocybin, MDMA, and, ketamine) (Nutt, David. 13.1 (2015): E1002047. Web). Another problem that researchers are facing has to do with the Scheduling System for the drugs used in the clinical trials. Most research on Schedule 1 drugs is almost impossible to complete because many research institutions, such as hospitals and universities, are ban from holding sufficiently harmful drugs, like Schedule 1 drugs; also, many researchers do not have the time, money, or, energy to go through these regulatory hurdles (Nutt, David. 13.1 (2015): E1002047. Web). For example, research institutions have the ability to get a Schedule 1 license to continue their research, but in the UK, it can take up to a year to get this license and can cost up to €5,000 for the license and the additional security required to protect these drugs (Nutt, David. 13.1 (2015): E1002047. Web). The law has caused more damage to society than good by impeding medical progress due to the limitations researchers face because of ‘out-dated’ drug regulations that are still being used in the United States (Nutt, David. 13.1 (2015): E1002047. Web). One question I feel that government officials, making these drug regulations and laws, and, the FDA, need to think about are: are these regulations on illegal drugs still relevant to society’s ideals/views on mental health, today? In recent years, research studies using illegal drugs as a long-term treatment for certain mental disorders, have had results that show the new treatments used in these clinical trials to be more beneficial than traditional medical treatments (Nutt, David. 13.1 (2015): E1002047. Web). Regulations on drugs needs to change in order for this medical progress to continue, along with the statuses of different scheduled drugs. For example, in the current scheduling system, marijuana is placed in the same category as heroin, one the most powerful, addictive, and, dangerous substance in this country; although, marijuana and heroin are not classified as the same type of drug nor do these two drugs share the same side-effects (Jacobs, Harrison. Business Insider. 22 May 2016).  

The solution to change the current scheduling system and illegal drug regulations in medical research seem simple, just change the scheduling system and the ‘out-dated’ regulations. This can be done by each national government redefining the UN Schedule 1 drugs to Schedule 2 to continue these research studies and having research institutions hold these drugs with other Schedule 2 drugs they currently house (Jacobs, Harrison. Business Insider. 22 May 2016). While researchers work to uplift this ban on pharmacological innovation and research for current Schedule 1 drugs, it’s important to encourage and support scientists that oppose harmful new legislations, such as, bans on chemicals (Nutt, David. 13.1 (2015): E1002047. Web). Government officials that create these drug regulations and our current scheduling system need to redefine the UN Schedule 1 drugs to Schedule 2 in order to continue this breakthrough advancement in modern medicine. These changes in illegal drug regulations will inevitably ease the regulatory burdens to research and will make clinical research easier without significant risk to participants, with no increased risk of diversion (Nutt, David. 13.1 (2015): E1002047. Web). 

 

Cited Sources:

Nutt, David. “Illegal Drugs Laws: Clearing a 50-Year-Old Obstacle to Research.” 13.1 (2015): E1002047. Web.

Jacobs, Harrison. “The DEA treats heroin and marijuana as equally dangerous drugs.” Business Insider. 22 May 2016. Business Insider. <https://www.businessinsider.com/us-drug-scheduling-system-heroin-marijuana-2016-5>.

Insight to Ketamine Research and Concerns

Researchers have found that Ketamine or off-label Ketamine are the most important advances in treatment for those who suffer from major-depressive disorder, especially for those who don’t respond to tradition treatment such as, taking prescribed anti-depressants or electroconvulsive therapy (Singh, Morgan, Curran, Nutt, Schlag, and Mcshane. (2017): 419).  A crossover study of seven participants in 2000 drew attention to using Ketamine as an alternative treatment for major depressive disorder; six years later, researchers found from a study of seventeen patients that suffered from treatment-resistant major depressive disorder showed that 71% of participants said their depressive symptoms were reduced by over 50% within twenty-four hours of the ketamine administration (Singh, Morgan, Curran, Nutt, Schlag, and Mcshane. (2017): 419). Researchers conducted a follow-up with patients of this study, the results showed that about a week later a third of the participants sustained the same response as the first administration of ketamine (Singh, Morgan, Curran, Nutt, Schlag, and Mcshane. (2017): 419). Other studies have shown that there is correlation between the reduction of suicidal ideations in patients with major-depressive disorder and the proper usage of ketamine, but scientist are still doing research to prove if this correlation is accurate or not (Singh, Morgan, Curran, Nutt, Schlag, and Mcshane. (2017): 419). In the recent years, research has begun to assess the potential of using ketamine as a form of pain management for those that suffer from Complex Region Pain Syndrome (CRPS) or cornice pain, instead of traditional medications, such as, opioids, anti-seizure medications, and anti-depressants or SSRIs (Singh, Morgan, Curran, Nutt, Schlag, and Mcshane. (2017): 419). From the graph below, you can see the extreme reduction in depressive symptoms after a dose of administered ketamine (0.5mg/kg) over a span of time of injection to two weeks later, and the benefits of ketamine really show:

<http://blogs.discovermagazine.com/neuroskeptic/2012/03/07/ketamine-magic-antidepressant-or-expensive-illusion/#.XK1iDetKjBJ>

Although ketamine is beginning to show breakthrough medical advances there are still concerns with the use of ketamine and making it accessible to the general public. Theses concerns derive from the fear of ketamine being misused as a recreational drug and the long-term side effects caused by this abuse, thus making it more difficult for these studies to proceed because of the government and FDA regulations on recreational drugs (Singh, Morgan, Curran, Nutt, Schlag, and Mcshane. (2017): 420). Autonomy is another concern for medical professionals, due to the fact, that doctors could either dose the patient with too much ketamine, causing complete disassociation, or, the doctor could administer too little and have not outcome at all (Singh, Morgan, Curran, Nutt, Schlag, and Mcshane. (2017): 422). Although there are still concerns, the use of ketamine in patients that suffer from major-depressive disorder has shown to be extremely beneficial in reducing their depressive symptoms, and for others, ketamine has shown correlation in reducing a patient’s suicidal ideation.

By restricting the use of ketamine in clinical trials, the government and FDA are taking away a long-term treatment plan for those who suffer from major-depressive disorder, which has already been shown to be more effective than traditional anti-depressants. This long-term treatment could reduce the suicide rates in the United States, along with the use of opioids by using ketamine as a management for pain instead of morphine or oxycontin, thus reducing the opioid crisis, which arose almost three decades ago in America.

 

Cited Sources:

Singh, Morgan, Curran, Nutt, Schlag, and Mcshane. “Ketamine Treatment for Depression: Opportunities for Clinical Innovation and Ethical Foresight.” The Lancet Psychiatry 4.5 (2017): 419-26. Web <https://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366%2817%2930102-5/fulltext>

Image:

Neuroskeptic. “Ketamine – Magic Antidepressant, or Expensive Illusion?” Discover Magazine. 07 Mar. 2012. 09 Apr. 2019 <http://blogs.discovermagazine.com/neuroskeptic/2012/03/07/ketamine-magic-antidepressant-or-expensive-illusion/#.XK1iDetKjBJ>

MDMA Research and Results

MDMA has been used in psychotherapy and research for long-term PTSD treatments. Studies administering regulated doses (between 0.2 to 1.7 mg) of MDMA combined with different forms of psychotherapy have had very positive results in ‘healthy people’; the results from these studies have shown the increase of dopamine, serotonin, and, endorphins neurotransmitters, as one of the effects of MDMA, in combination with being in a safe and supportive environment can extinguish the fear associated in traumatic events that cause PTSD, much like exposure therapy (Feduccia and Mithoefer. 2018.). Scientist and the FDA are calling MDMA assisted psychotherapy as breakthrough form of psychotherapy.  Research from MDMA administered psychotherapy, like many other recreational drug associated psychotherapy studies, has been delayed because of the fact that MDMA is a Schedule 1 drug, and researchers are still seeing that some participants are not progressing the same as ‘healthy’ participants or show no difference after treatment (Feduccia and Mithoefer. 2018.). These government restrictions on drugs are causing revolutionary long-term psychological treatments to be put on pause, or for research to be stopped completely; but the real question is, why is the government restricting research that so beneficial for people who have survived traumatic events? For example, this treatment of psychotherapy could be used for war veterans, natural disaster victims, and, victims of rape and/or assault to recondition the memory of fear associated with trauma into a more tolerable emotion (Feduccia and Mithoefer. 2018.). In the research that I have come across, scientist comment on how this treatment is more effective or helpful to ‘healthy’ participants, but why is this? What are the qualifications of being a ‘healthy’ participant in these studies? What could be causing this inconsistency between healthy and non-healthy individuals throughout the trials of this study?

<https://maps.org/research/mdma

 

Cited Sources:

Feduccia, Allison A., and Michael C. Mithoefer. “MDMA-assisted psychotherapy for PTSD: Are memory reconsolidation and fear extinction underlying mechanisms?” Progress in Neuro-Psychopharmacology and Biological Psychiatry. 07 Mar. 2018. Elsevier. 26 Feb. 2019 <https://www.sciencedirect.com/science/article/pii/S0278584617308655>

Image:  <https://maps.org/research/mdma>

Can Illegal Drugs Actually Improve Your Mental Disorders?

From the title you’re probably thinking, what illegal drugs are they talking about? This blog will be referring to two different types of drugs, one of these drugs is not commonly known by the public but, one of these drugs is a very common ‘party’ drug called MDMA, also known as Molly or Ecstasy.  MDMA, usually comes in tablet or capsule form that can be taken orally, stimulates the release of neurotransmitters in the brain, but in this case serotonin is released, with a high that lasts between three and six hours (“MDMA: Effects, Hazards & Extent of Use.” Drugs.com. 2018. L. Anderson, PharmD.). Molly enhances people’s sense of pleasure, self-confidence, increases energy, and, often people feel ephori when on MDMA (“MDMA: Effects, Hazards & Extent of Use.” Drugs.com. 2018. L. Anderson, PharmD.). Molly was used in psychotherapy in the early 1970s and soon turned into a street drug in the 1980s, but scientist today are seeing that Molly can help treat those who are suffering from PTSD (Post Traumatic Stress Disorder).  Scientist are using the effects of MDMA with psychotherapy to reduce the fear related to traumatic memories and it’s been showing results. This form of treatment is creating a neural setting primed for new learning and extinguishing fear associated with traumatic memories (Feduccia and Mithoefer. “MDMA-assisted psychotherapy for PTSD”. Progress in Neuro-Psychopharmacology and Biological Psychiatry. 2018. Elsevier).

Now to the last drug, Ketamine. I know you might be saying this to yourself, “what is ketamine?” and “what would Ketamine be used for?” and I will tell you. Ketamine is a medication (mostly known for being a dissociative) used for starting and maintaining anesthesia, it induces a trance-like state of pain relief, memory loss, and, sedation (“Ketamine.” Wikipedia. 12 Mar. 2019. Wikimedia Foundation. 1 Mar. 2019). There have been studies that show low doses of ketamine may reduce morphine use, nausea, and vomiting after surgery; although there is still not much research behind the use Ketamine in psychological treatment, but the medical world their starting to realize that Ketamine is viable option for those that suffer from chronic pain and in some cases of CRPS (complex regional pain syndrome) low doses of Ketamine can be a form of treatment (“Ketamine.” Wikipedia. 12 Mar. 2019. Wikimedia Foundation.). Ketamine has also been found to be a fast-acting antidepressant in cases of major-depressive disorder and bipolar depression; scientists have also found that Ketamine could be used as an alternative to postoperative pain management instead of using morphine (“Ketamine.” Wikipedia. 12 Mar. 2019. Wikimedia Foundation.). Although Ketamine has not been approved by the FDA as a antidepressant, it’s molecule cousin,  esketamine, was recently approved in February 2019,  as an antidepressant in a nasal spray form; this nasal spray is suppose to work as a dopamine reuptake inhibitor (“Esketamine.” Wikipedia. 12 Mar. 2019. Wikimedia Foundation.).

Even though there is not much research behind using Ketamine and MDMA as a treatment plan with psychotherapy, I hope the video below gives you more insight into different treatment plans for mental disorders and pain management.

This video should give some insight to what Ketamine is and how beneficial Ketamine is now coming out to be. In this video Ketamine helps reduce Carol’s major-depressive disorder: <https://www.youtube.com/watch?v=3hcXiHYSt3k>

 

Cited Work

Video:

Carole, a Ketamine Therapy patient, discusses her transformation. Dir. Ketamine Wellness Centers. YouTube. 23 June 2017. 13 Mar. 2019 <https://www.youtube.com/watch?v=3hcXiHYSt3k>.

Sources:

“MDMA: Effects, Hazards & Extent of Use.” Drugs.com. 24 Sept. 2018. L. Anderson, PharmD. 24 Feb. 2019 <https://www.drugs.com/illicit/mdma.html>.

Feduccia, Allison A., and Michael C. Mithoefer. “MDMA-assisted psychotherapy for PTSD: Are memory reconsolidation and fear extinction underlying mechanisms?” Progress in Neuro-Psychopharmacology and Biological Psychiatry. 07 Mar. 2018. Elsevier. 26 Feb. 2019 <https://www.sciencedirect.com/science/article/pii/S0278584617308655>

“Esketamine.” Wikipedia. 12 Mar. 2019. Wikimedia Foundation. 1 Mar. 2019 <https://en.wikipedia.org/wiki/Esketamine#cite_note-MDS-2>

“Ketamine.” Wikipedia. 12 Mar. 2019. Wikimedia Foundation. 1 Mar. 2019 <https://en.wikipedia.org/wiki/Ketamine>.

The History of Psychedelics and It’s Come Back to Modern Medicine

By Ben Mills - Own work, Public Domain, https://commons.wikimedia.org/w/index.php?curid=14584151

For those that may not know, the image above is the molecule of Lysergic acid diethylamide, also known as LSD or acid. LSD is one of the most commonly known psychedelics, besides magic mushrooms, but I’ll get into those a little later. Acid was accidentally synthesized by Albert Hofmann in 1938, he was actually looking for a drug to stimulate circulation; five years later, Albert accidentally ingested a small amount of LSD that made him realize he had created something both, powerful and terrifying (Pollan, Michael. Introduction. 2018. Pg 2). About twelve years after Albert Hofmann discovered LSD, a Banker and a Mycologist, by the name of R. Gordon Wasson, traveled to Huautla de Jiménez, a small town on the southern border of Mexico, where they both sampled Magic Mushrooms, or in official terms, the molecule psilocybin.  Psilocybin has been around for thousands of years, Native Americans in Mexico and Central America use to eat these mushrooms as a sacrament, but once Spanish Conquistadors invaded their land magic mushrooms were driven underground (Pollan, Michael. Introduction. 2018. Pg 2). These two psychedelics made their way into the psychotherapy field in the early 1950s and these two molecules discovered counterculture. 

In the early 1950s, scientists discovered the role of neurotransmitters in the brain but, they were also introduced to LSD during the same time period. The quantities of LSD measured in micrograms that produce the same symptoms as psychosis inspired neuroscientists to search for the neurochemical basis of mental disorders (Pollan, Michael. Introduction. 2018. Pg 2). Psychedelics were used to treat a variety of disorders, such as, alcoholism, anxiety, and, depression; for most of the 1950s and early 1960s many psychiatric centers considered acid and magic mushrooms as ‘miracle drugs’ (Pollan, Michael. Introduction. 2018. Pg 3). The sixties is where the counterculture really started to appear because young adults had a rite of passage all their own, an ‘acid trip’; LSD’s effect on society was disruptive (Pollan, Michael. Introduction. 2018. Pg 3).  The dark side of psychedelics, like bad trips, psychotic breaks, and, suicides, were starting to get a lot of publicity because of the young adult wanting to go on their own rite of passage: an ‘acid trip'(Pollan, Michael. Introduction. 2018. Pg 3). In the beginning of 1965, the excitement surrounding these new drugs quickly caused moral panic, that by the end of the decade, psychedelics were outlawed and forced to go underground (Pollan, Michael. Introduction. 2018. Pg 3). About two decades later, groups of scientists believed that something had been lost from science and society and that this situation should be resolved and to find what’s missing.  

After many decades of suppression, psychedelics are having a comeback and even in a field of psychotherapy, where it first appeared. A new generation of scientists are testing their potential to heal mental illnesses, while other scientists are using psychedelics along with with new brain-imaging to explore the links between brain and mind (Pollan, Michael. Introduction. 2018. Pg 4). The 1960s platitude of psychedelics offered a way to understanding and ‘expanding’ the mind in a different perspective.  

 

Cited Sources

Image of LSD molecule: <ahref=”https://commons.wikimedia.org/wiki/File:LSD-2D-skeletal-formula-and-3D-models.png”>via Wikimedia Commons</a>

Pollan, Michael. Whole Book. How To Change Your Mind: What The New Science Of Psychedelics Teaches Us About Consciousness, Dying,. New York: Penguin Books, 2018.

My Reasoning Behind Researching the Effects of Psychedelics as a Treatment Plan for Mental Illnesses

Attribution-ShareAlike 4.0 International (CC BY-SA 4.0)

Attribution-ShareAlike 4.0 International (CC BY-SA 4.0)

 

I’m researching the use of recreational drugs as an alternative method to tradition medications to treat mental illness, such as, anxiety, depression, etc. Because I would like to find out if recreational drugs have the potential of more beneficial for some patients in the long run.  I wanted to do this topic because in the past year I was diagnosed with Generalized Anxiety Disorder (GAD) and Panic Disorder and it’s taken a really big toll on my life. Ever since I can remember, I was always anxious, literally walking into grocery stores or school or even a family event use to trigger a panic attack, and it sometimes still does. The tradition method has a lot of trouble with me personally from switching from one anti-anxiety to anti-depressants back to anti-anxieties, so I’ve personally been looking for an alternative method where I don’t have continuously change prescriptions.

People don’t realize how crippling these diseases can actually be and how much it takes out of people, and people also don’t realize how the traditional treatment can cause damage in patients that suffer from mental illness. With the tradition method of prescribing medicine, it can take months or even years to find a combination of drugs to help with the disease and even when the drugs are working for a patient for many years the body can become immune to the drugs, thus causing the patient to go through this process all over again. Some things I would like to explore with this topic is not only psychedelic drugs but recreational drugs as a treatment for mental illness. For example, in one of the articles I read it mentioned how people are using Ketamine and MDMA for treating depression and PTSD (Feduccia, Allison A., and Michael C. Mithoefer. NeuroImage. 07 Mar. 2018. Academic Press Pg 2). I also find it very interesting that modern medicine is starting to see that we can use these illegal drugs in a way of helping people instead of ‘just for fun’.

Pretty much what I would like to get out of this blog and for my audience understand is that there is an alternative method for treating mental illnesses, and how beneficial using recreational drugs as treatment could be in the long run. I have a few questions still, like whether this is actually going to beneficial or more damaging to country with our drug epidemic going on? And whether or not congress is going to be okay with the use of illegal substances in treatment programs? Would they pass a bill allowing it? Has this been done before? And how many times has someone attempted to try and use illegal drugs as treatment for mental illness?  Can government regulation on drugs be apart the tragedies related to drugs in society?

Cited Work

Image: Attribution-ShareAlike 4.0 International (CC BY-SA 4.0) https://commons.wikimedia.org/wiki/File:Mental_Disorder_Silhouette.png#/media/File:Mental_Disorder_Silhouette.png 

Sources:

Feduccia, Allison A., and Michael C. Mithoefer. “MDMA-assisted psychotherapy for PTSD: Are memory reconsolidation and fear extinction underlying mechanisms?” NeuroImage. 07 Mar. 2018. Academic Press. 22 Feb. 2019

<https://www.sciencedirect.com/science/article/pii/S0278584617308655>.