Brian Chadwick, Co-founder & Executive Director, 100 Million Ways.
The COVID-19 (C-19) pandemic is like nothing else we have experienced in America, and vulnerable populations are in trouble as a result. Even with the availability of a vaccine, this virus’ global presence, adaptability, and sustainability makes it a rare breed. And there is no rest for the weary as poverty, homelessness, hunger, mental illness, immunosuppression, PTSD, and the opioid crisis are all worsened by a virus that just won’t quit.
C-19 has shown the vulnerabilities and deficiencies in America’s addiction services. For people with the disease that is substance use disorder (SUD), isolation found opioid users with limited clinic support, unplanned and unsupported opioid withdrawal, and less expensive, more deadly street synthetics readily available to fill the ugly void. Data from the Overdose Detection Mapping application program at Johns Hopkins indicates, “opioid overdoses increased in March 2020 by 18% compared to the same month in 2019, 29% in April 2020, and 42% in May 20201”. According to the American Medical Association, “over 40 states reported increases in opioid-related deaths during the pandemic”. The CDC just announced there were over 100,000 pandemic-related overdose deaths – the most deaths ever in 12 months. Subscribe to the Trialsitenews “COVID-19” ChannelNo spam – we promise
There was a dark twist in the April 24, 2020 LA Times headline, “Coronavirus chokes the drug trade — from Wuhan, through Mexico, and onto U.S. streets. Wuhan is known for producing chemicals used to make powerful synthetic opioids and narcotics. Traffickers rely on the movement of goods, which travel bans have stymied. And Mexican production of fentanyl and methamphetamine have been hit hard.” While one might celebrate such a story – fewer drugs on the street – according to UCSF School of Medicine: “When there is decreased supply, addicts often use substitute drugs with which they may be less familiar. They also can change habits, making dosing less reliable. Overdoses go up, paradoxically, as supply goes down2”. And fentanyl (aka: TNT) has found its way into the streets of America; with so many derivatives, some of the chemicals are not even illegal because drug enforcement has not seen them before.
Tackling the supply side of this problem seems a perpetual battle and cannot, unto itself, win the war on drugs.
It can be hard to feel empathy for addicts. It requires often reminding oneself that opioid addiction is a disease, and the behaviors of an addict are part of that disease. It’s worse as there are too many stories about a patient starting an opioid to treat pain and becoming an accidental addict – not an excuse – an observation.
This pandemic experience has created a new normal for many of us, but it is essential to point out that individuals with OUD and others in at-risk populations will not have a new normal because they did not have an old normal. Therefore, for them, everything has just become more difficult.
Standard of Care.
There are two medication options used to treat opioid addiction and withdrawal called medication-assisted treatments (MATs): Buprenorphine and Methadone. Both medicines were hard to get during the first 18 months of the pandemic; clinics were shuttered, and a physician needed to be “certified” to write a prescription. The issue of physician certification has been relaxed due to the C-19 pandemic. And this may be expanded to include PAs and NPs. Pain management clinics are open. It should be easier to get access to MATs – that is – if people are willing to make the commitment to quit and physicians are willing to accept the responsibility to treat them as patients. One problem with both Methadone and Buprenorphine is they are both potentially lethal, like the opioids they are replacing.
A new complexity has entered this complex scene; an algorithm-driven software called NarxCare. It was built to better manage opioid distribution. The algorithm seems to have gone awry. In practice, it also further stigmatizes people already stigmatized due to their dependence on opioids, without which they have untreatable chronic pain. And while it can be a thin line, opioid dependency is different from opioid addiction. Moving the “war on opioids” to the physician’s office and the pharmacy is a mistake. The addition of the NarxCare system is a solution that creates a new problem. A person suddenly rejected because of an algorithm, may become desperate. The NarxCare system should extend its algorithm to provide a person denied an opioid prescription due to their NarxCare score, a small amount of opioid tablets, or Buprenorphine, or Methadone with an immediate referral to a pain management clinic set up for this purpose. That would not be so hard to do.
There is mounting real-world evidence about using cannabis-as-medicine as an adjunct to opioid treatment for chronic pain. The goal is harm reduction. One less opioid dose each day will decrease overdose deaths. A National Academy of Sciences report in 2017 concluded, “There is evidence that cannabis is effective for the treatment of chronic pain in adults3.” The Alcohol and Drug Abuse Institute at The University of Washington studied cannabis as a substitute for opioid medication in an online survey of 2897 opioid patients also using cannabis-as-medicine. “Ninety-seven percent (97%) of patients reported using fewer opioids when using cannabis-as-medicine and experienced more tolerable side effects with the combination than with opioids alone (92%).4” A study in The Journal of the American Academy of Orthopedic Surgeons from May 2020 states, “Those states where medical cannabis is legal show a statistically significant reduction in aggregate opioid prescribing of 144,000 DAILY doses (19.7%)5.”
Of course, even as cannabis has been legalized in more than half the states in America, until cannabis is de-scheduled as a class 1 narcotic by the federal government, only limited clinical research can be done to determine the actual safety and efficacy profile of cannabis-as-medicine in treating pain, as an adjunct used with opioids to decrease the amount of opioids a person needs to manage their chronic pain or their OUD, and for numerous other diseases and disorders.
In an article published by NEJM in July 2017 by two prestigious authors, Nora Volkow, MD, Director of NIDA, and Frances Collins, MD Ph.D., Director of NIH, proposed three innovative scientific solutions in response to the opioid crisis:
- “Develop better overdose-reversal and prevention interventions to reduce mortality.
- Find new, innovative medications and technologies to treat opioid addiction.
- Find safe, effective, nonaddictive interventions to manage chronic pain.6”
In 2021, NARCAN use has increased significantly, saving many lives – especially the innovation that is user-friendly intranasal naloxone formulation (Narcan Nasal Spray). Additional innovative treatment options are starting to emerge. Cannabis-as-medicine is an example. While cannabis has addictive features, it is not lethal. Nora Volkow, Director of the National Institute on Drug Abuse (NIDA), who is not bullish on the potential of cannabis-as-medicine, said, “It’s been difficult to do research because of the Schedule 1 process” referring to the restricted federal drug classification. She said NIDA is working with DEA and FDA for solutions “that will make research on marijuana less cumbersome.” It should be noted that cannabinoids to treat chronic pain are included in the strategies presented by Volkow and Collins in the NEJM article referenced above.
There are safe, effective, nonaddictive pain management treatments, such as IV Meloxicam, for in-patient, post-operative surgical pain, often used with low dose opioids. This approach limits the introduction of too many addictive and lethal pain medications, and better sets the stage for limited opioid use upon discharge. The patient is advised that the complete elimination of pain is not often obtainable. This is part of a new pain management paradigm. And while the psychology of pain and the expectations of pain management are being re-invented is a good thing – the opioid epidemic is now.
Drugs already approved by FDA are also being reevaluated and repurposed as possible opioid alternatives – but there is currently only a mixed-bag of non-opioid pain management options for out-patient prescriptions to treat severe and chronic pain. Non-pharmacologic alternatives (massage, psychological support…) are expensive and probably unrealistic options for most of this population, and, while the NOPAIN Act before Congress is intended to expand insurance coverage in these areas, this is to be determined.
Step 1: nonopioid analgesics (Acetaminophen, NSAIDs…).
Step 2: weak opioids, with or without a non-opioid alternative or adjunct.
Step 3: strong opioids, with or without a non-opioid alternative or adjunct.
The WHO pain ladder says it all: weak opioids and strong opioids. Alternatives such as acetaminophen, NSAIDs, select anti-convulsive and anti-depressant medications, topical agents and nonpharmaceutical approaches don’t seem to cut it when treating acute or chronic pain. At least not yet.
The Center for Disease Control (CDC) has created a new guideline for prescribing opioids for chronic pain – “intended to improve communication between providers and patients about the risks and benefits of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy, including opioid use disorder and overdose7.”
The bottom-line is that opioid addiction is a disease. The medical term is Opioid Use Disorder (OUD). Substance Use Disorder (SUD) covers the broader group of illicit abusable drugs including methamphetamine, cocaine, benzodiazepines, and heroin. Opioids are addictive and lethal. The quality of life for someone addicted to opioids is dismal. The opioid epidemic is out of control and the recovery process is wanting. Sobriety does not have to be the goal – at least the primary goal. Harm reduction – decreasing overdose deaths is the primary goal.
“Mental health is health” has become a common phrase as the COVID-19 pandemic’s toll on mental wellness becomes clear. Mental health is a continuum that, simply put, can stretch from feeling good to struggling (and back again). From the glass-half-full perspective, the pandemic experience has increased the reach and accessibility of mental health services.
Psychological, sociological. and emotional support are as important for severe and chronic pain management as medications. A NIDA Research Report indicates, “43% of people in treatment for nonmedical use of prescription painkillers have a diagnosis or symptoms of mental health disorders, particularly depression and anxiety. About half of people who experience a mental illness will also experience a substance use disorder and vice versa8”. A long-term treatment plan could include innovations such as a vaccination, gene therapy, biotechnology, implanted devices, and non-opioid pain medications strong enough to substitute for opioids. Waiting is the hardest part.
Cannabis-as-Medicine, Prove It.
With limited pharmacological alternatives currently available for out-patient acute or chronic pain management and with the lethal potential of the medications used to treat withdrawal (Methadone and Buprenorphine), it seems a worthwhile research question to take a look at cannabis-as-medicine. Cannabis is available. Cannabis is not lethal. There is sufficient clinical evidence to warrant clinical trials. Even if cannabis-as-medicine works only as an adjunct to opioids to manage severe and chronic pain, people using opioids will need fewer opioids. Fewer opioids equals better quality of life, fewer overdoses and deaths, and less cost to society. Let’s spend $200 million to answer this research question. That is 0.0026% of the cost estimated by CDC ($78.5B) for one year of the opioid epidemic in America. There needs to be more options.
There is a large volume of real-world data about the safety and efficacy of cannabis-as-medicine (medical marijuana) in several diseases and disorders – and real-world data has value – but there needs to be clinical trials to determine the scientific and statistical impact cannabis-as-medicine has on opioid dependence and OUD. As mentioned earlier in this article, since cannabis remains a schedule 1 controlled substance, people with unwanted opioid dependence or OUD interested in trying cannabis for this purpose, will have to wait for clinical trials to answer research questions that could help change their lives (and the lives of people with epilepsy, depression, anxiety, Parkinson’s Disease, MS…)
Does cannabis-as-medicine, when added to an opioid pain management regimen, significantly:
1. reduce opioid use?
2. reduce opioid overdose deaths?
3. improve Quality of Life (QoL)?
The Multidisciplinary Association for Psychedelic Studies Foundation (MAPS) paved the way for studying an illicit drug called 3,4-methylenedioxymethamphetamine (MDMA), with properties proving effective in treating PTSD. MAPS has FDA approved phase 3 clinical trials data with dramatic results showing significant improvement in PTSD symptoms when combined with current therapeutic approaches.
Cannabis (aka marijuana, pot or weed) and MDMA (aka ecstasy or molly) were both on the radar screen of researchers in the 1960s – but took an illicit detour. So there is an understandable social concern when considering illicit drugs as medications. But the word medication is simply defined as a substance used for medical treatment. Through persistence and patience, the MAPS research teams are making a difference. It can be done. Cannabis is next.
So When Will the Federal Government De-schedule Cannabis?
In America, the 1970 Controlled Substances Act9 (CSA) classifies cannabis as a Schedule I substance, the highest level of drug restriction, as having:
- Potential for abuse
- No currently accepted medical use.
- No accepted safety
Potential for abuse exists with cannabis and both drugs – Buprenorphine and Methadone – approved as substitutes for opioids as treatments for OUD. The difference: cannabis is not lethal.
Cannabis has accepted medical use as the National Academies of Sciences (previously referenced) concluded that cannabis is effective in treating chronic pain and chemotherapy-induced nausea.
While only FDA clinical trials can scientifically prove safety, the long real-world history of cannabis use suggests an acceptable safety profile.
And despite cannabis legalization in 36 states, District of Columbia, Guam, Puerto Rico and U.S. Virgin Islands, and the increasing use of cannabinoids for a variety of diseases and conditions in addition to recreational use, the federal government has yet to de-schedule cannabis; not even for medical/clinical research. Change may be upon us though. Chuck Schumer, Senate House Majority leader, said he would push for legalization through the Marijuana Freedom and Opportunity Act10 – proposed federal legislation that would de-schedule cannabis from the Controlled Substances Act and enact various criminal and social justice reforms related to cannabis, including the expungement of prior convictions. Cannabis de-scheduling seems imminent – but it has seemed imminent for a while.
As mentioned above, The National Academy of Sciences found cannabis an effective treatment for chronic pain in adults with additional evidence that cannabis is effective in treating chemotherapy-induced nausea. (NAS Report 2017). Just one of those indications repudiates Federal policy. And there is a large catalog of real-world evidence that supports the safety and effectiveness of cannabinoids in many disease states and disorders.
Yet today, investigators wanting to research cannabis and cannabinoids must navigate a series of review processes that involve the National Institute on Drug Abuse (NIDA), the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), institutional review boards, offices or departments in state government, state boards of medical examiners, the researcher’s home institution, and potential funders11.
As a result, research on the health effects of cannabis and other cannabinoids has been limited. This lack of scientific evidence-based information on the health effects of cannabis and other cannabinoids poses a public health risk, not only because of the potential to treat OUD (and other diseases and disorders) but in general, as patients, recreational users, health care professionals, and policymakers do not have the evidence they need to inform good decisions regarding the use of cannabis and other cannabinoids.
Cost of the Opioid Epidemic
CDC estimates the cost of the Opioid Epidemic is $78.5 billion/year. That number is big and will be bigger in 2020 and 2021. It is hard number to break down. Cost estimates for one person with the disease that is OUD as compared to people without OUD are still dramatic but easier to digest:
- $15,000 more each year in health care costs than a similar patient not diagnosed with OUD.
- $38,000 more each year in lost productivity and disability costs than a similar patient not diagnosed with OUD.
- $2,000,000 in mortality costs, life-earnings lost for people who die prematurely from opioid overdoses (ages 15-34). It is not less expensive to die.
- $20,000 to treat Neonatal Abstinence Syndrome (NAS).
A lot of other legal, social, and healthcare costs add up to that $78.5B12 number. And with about 2.3M Americans with OUD it is easy to see how fast these costs get out of control.
The Opioid Crisis Can be Fixed.
In the 70s, Dr. Bruce Alexander placed a rat alone in a cage. Researchers offered the rat two water bottles – one bottle contained just water, and the other bottle had water with heroin. The rat repetitively drank from the heroin-laced bottle until he overdosed and died. The experiment was repeatable. Dr. Alexander wondered: “Is this all about the drug, or could it be related to the setting?” To test this idea, he put rats in “rat parks,” a community where they were free to roam, play, socialize and have sex. Given the same two types of water bottles, when in their community, the rats preferred the plain water(over the water with heroin). And if they did drink the heroin-laced water, they did so intermittently, not obsessively, with NO overdoses13.
Community is defined as “a group living in the same place or having a particular characteristic in common, as well as a feeling of fellowship with others, a sharing of common attitudes, interests, or goals.” We all need a community to survive and being part of a community is key to recovering from OUD. The community, at large, must first accept that addiction is a disease as the stigma sucks. A patient said, “I’ve lost jobs. I’ve lost friends. I’ve lost roommates. You know, you lose everything.” Pennsylvania has stated a program called Life Unites Us to take on the stigma of OUD. The program is new so there are limited outcomes to report – but positivity counts.
To reduce the stigma, the word junkie has to disappear from the vernacular; but even the word addiction is not an accurate description for those dependent on opioids to manage chronic pain. Also, thoughts conjured up by the word addiction do little to support the reality that addiction is a disease, not a moral shortcoming. Dependence, while it can be a step or two away from addiction, is a physical dependence on a substance. Dependence is characterized by the symptoms of tolerance and withdrawal. The word addiction is more complicated. Addiction is marked by a change in behavior caused by the biochemical changes in the brain after continued opioid abuse. Substance use becomes the main priority of the addict, regardless of the harm they may cause to themselves or others. Addiction causes people to act irrationally when they don’t have the substance to which they are addicted in their system14.
In October 2017, the federal government declared the opioid crisis a national public health emergency. The following year America had a small decrease in overdose deaths. Promising, but not enough. Then came the pandemic.
The American Community.
The pandemic inspired the American community to consider options, novel approaches, and innovations compared to the way things have been done. For example, do past drug control policies need to be changed, and are there more sensible policies for treating unwanted opioid dependence and OUD as a disease? Are non-violent crimes driven by OUD better addressed medically than legally?
A new blueprint for confronting this epidemic has emerged that is better than algorithms that merely restrict access; it is a public health approach. A public health approach includes increasing access to medications and treatments for people suffering from substance use disorder (SUD). It also implies increasing the availability of harm reduction services, including life-saving emergency medications like naloxone, which can prevent an overdose from becoming a death, raising awareness, and reducing stigma through public communication campaigns. Finally, it also means lending creativity and alternatives to a sub-optimal system.
The Drug Addiction Treatment and Recovery Act (Measurement 110)15 will transition Oregon’s drug policy from a punitive and criminal approach to a humane and practical approach stating, “People suffering from the disease that is OUD are more effectively treated with health care services than with criminal punishments”.
Like Oregon, Canada is experimenting with a program called Safer Supply16 – prescribing a safe supply of pharmaceutical grade opioids – guaranteeing quality and dosage – decreasing reliance on deadly street options. Safer Supply may be an imperfect tool in response to an overwhelming crisis. Implementation a safe supply program is a challenge for multiple regulatory, legal, and operational reasons. Therefore Safe Supply needs to be a realistic approach and prove positive to bring value.
Measure 100 and Safe Supply stem from published accounts of addiction-related successes realized in Portugal. A 2009 Cato Institute study of Portugal’s decriminalization of all drugs in 2001, reported a dramatic reduction of pathologies associated with drug use, such as sexually transmitted diseases and overdose deaths17. A 2015 European Drug Report found that Portugal’s drug overdose death rate is significantly lower than the European Union average18.
The scope and collaboration required to implement these programs create concerns for the success of the Safe Supply or Measurement 110 models in America. Oregon has guts. There are a lot of loose ends. Nonetheless, the federal government needs to look at alternatives because current approaches to treating opioid addiction are not working. More Americans died from an opioid overdose in this pandemic year than ever before. Synthetics are less expensive, available everywhere, and much more deadly than pharmaceutical-grade opioids. And too many people are in jail-hell for non-violent drug-related crimes.
Conclusion – The Pandemic has Created Opportunities
The glass is half full. The virus is persistent, but vaccinations and treatments for the SARS-COV-2 virus are becoming available in America. Opioid treatment programs are being recharged and looking to pick up some of the early momentum of the public health emergency declared in 2017. The opioid crisis in the new normal is preparing for people in a worsened state due to the pandemic – many vulnerable people barely getting by, and too many are dead. Multimodal and Innovative approaches to opioid use management are critical to overcoming the challenges that have emerged.
If you’re in Oregon or areas in Canada, measurement 110 and Safer Supply are options that may make sense – sobriety is a great aspiration, living more healthfully while still using combination treatments, including opioids for chronic pain, may be more realistic – and not dying is equally aspirational.
There will be more clinics with more alternative treatments for consideration. More physicians will be able to prescribe MATs – if they are willing.
People who are tired of the health dangers of opioid dependence or shattered by opioid use disorder may be able to use the momentum being created by actively addressing the challenges this pandemic is creating. In 2022 there will be better care pathways to and through the process of acute and chronic pain management, with more treatments for opioid withdrawal, maintenance, and recovery. There will be better insurance coverage for non-pharmacological addiction treatment alternatives, and more opportunities for diversion from jail to treatment programs. This pandemic has made America humbler, a little more afraid, a little less trusting, but more resilient. America can end the opioid crisis.