The numbers are staggering. An estimated twelve million Americans suffer from post-traumatic stress disorder (PTSD) according to data from the U.S. Department of Veterans Affairs, approximately 37% of whom are considered to have severe symptoms. At some point in our lives, six in ten men and five in ten women will experience meaningful trauma; approximately 6% of the population will go onto to suffer with PTSD. While the causes of PTSD are relatively easy to identify (combat, accidents, assault, etc), the symptoms can reveal themselves in confounding ways and the treatment modalities can be frustratingly ineffective for many. Data from the National Institute of Mental Health show greater prevalence of PTSD among women and with older Americans.
The healthcare industry has had a complicated history with developing proper therapeutic treatments for PTSD. Given the extraordinary urgency and overwhelming need, in part due to the trauma in war zones in Iraq/Afghanistan/Ukraine/Middle East, severely limited behavioral and mental health resources, and issues associated with the pandemic, there has been a renewed interest in psychedelics. Recent estimates from the Substance Abuse and Mental Health Services Administration showed that over $280 billion is spent annually on treatment services for mental health and substance use disorders, and this is barely adequate. While the most effective treatment for many is “talk therapy,” the healthcare system today simply does not have enough providers.
In response, the biotech industry has started to embrace a class of mind-altering compounds such as psilocybin, lysergic acid diethylamide (LSD), and 3,4-methylenedioxymethamphetamine (MDMA or Ecstasy or Molly). According to Psychedelic Alpha, there are now 49 public companies and 39 private companies that are developing products utilizing psychedelic compounds; there are even four ETFs facilitating investor trading in baskets of these stocks. And all of this without FDA approvals or legalization. The Wall Street Journal recently profiled Empath Ventures, which is raising a $10 million venture fund focused exculsively on hallucinogens.
The Multidisciplinary Association for Psychedelic Studies (MAPS) was created in 1986 to advance the medical, legal, and cultural appreciation for the role of psychedelics in treatment of PTSD and other intractable behavioral conditions. Supported by over 130 scientists and $44 million of funding, MAPS research has shown that these compounds are not addictive and do not cause organ damage. Much of its advocacy work has been to pressure the FDA to accept that these psychoactive compounds, when properly administered in micro-doses, can be highly efficacious as part of mainstream psychiatric approaches. A recent study in Nature showed that when administered to PTSD patients, 67% no longer showed signs of PTSD symptoms as compared to 32% in the placebo arm.
The history of psychedelics is complicated. More than 60 years ago, these compounds were both legal and yet on the fringes of therapeutic use. As the 1960s counterculture took hold and embraced the abuse of this class of drugs, the legislative response was to crack-down and criminalize them. Their acceptance was further undermined in the 1980s, and still is today, as Ecstasy and Molly swept the club scene with very disturbing incidents of “date rape” abuse. Further complicating a broader medical community acceptance is the patchwork regulatory framework. While illegal on a federal basis, the use of psychedelics is legal only in certain states and cities.
Further complicating the situation is the conflation of psychedelics with other drugs such as narcotics, tetrahydrocannabinol (THC, most commonly associated with cannabis), opioids, and other performance-enhancing drugs. While obviously distinct from psychedelics, the real societal issues created by those drugs often overshadows the potential and for many, the necessary, therapeutic applications of psychedelics. The massive opioid settlements roiling the pharmaceutical and drug distribution industries further clouds the discussion; just last month Teva settled all pending opioid cases for $4.25 billion. The Centers for Disease Control and Prevention (CDC) recently released a study showing that 3.7 million Americans injected themselves with drugs in 2018, which was a five-fold increase over 2011 and led to a spike in HIV and hepatitis C cases.
A recent New York Times study found that 13% of all U.S. veterans suffer from PTSD; for those returning from Iraq and Afghanistan, it is believed that could be as high as 20% – 25%. Studies have also shown that on average 17 veterans commit suicide every day. Between 2010 – 2019, 42k veterans died from a drug overdose. The need for more effective treatment is acute, obvious, and urgent.
The level of drugs prescribed is overwhelming yet still so many suffer, highlighting how inadequate current treatments still are. Over 8.9 million Americans were prescribed drugs last year for major depressive disorders, and yet, it is believed that 30% of those prescriptions had no effect. IQVIA prescription data in 2021 showed that there were 337.1 million scripts written for antidepressants. Covid has also had a significant impact. Per Express Scripts data, there was an 8.7% increase in antidepressants prescribed between 2019 – 2021, as compared to 7.9% increase between 2017 – 2019. CDC data revealed that 15.8% of all prescriptions in 2019 were for mental health conditions; undoubtedly, that will be quite a bit higher today.
The course of psychedelic treatment typically involves up to four monitored micro-dosed “trips” that can last anywhere from 90 minutes to several hours. A micro-dose is usually 5% – 10% of a normal dose which can create a therapeutic impact without the debilitating hallucinogenic high. Such an approach is believed to induce significant neuroplasticity which facilitates a “re-wiring” of the brain, although the precise mechanism of action is still not fully understood. While the actual drug may be relatively inexpensive, the overall supervised experience requires trained staff and facilities.
The need is not lost on the digital health industry, which is also looking to develop more cost-effective and scalable solutions to better manage and treat the PTSD population. While not only focused on PTSD solutions, since the beginning of 2018 approximately $11.2 billion has been invested in digital mental health companies according to Rock Health, causing it to be the consistently highest ranked clinical indication to attract funding. Interestingly, Innerwell recently raised a seed round to build a psychedelic telehealth platform to connect patients and therapists. In April 2022, Nue Life raised a large Series A round to launch a tele-psychedelic platform. A recent Grand View Research analysis concluded that the global mental health apps market was $4.2 billion in 2021 ($1.4 billion of which is in the U.S.) and will grow by 16.5% annually through 2030.
Much of this investor enthusiasm is based on the potential to dramatically improve provider productivity and address acute gaps in care. Adoption of these tools is consistent with greater appreciation of the power of virtual care models and demonstrated improved outcomes. As the healthcare system is moving to a more “meet the patients where they are” mentality, digital health solutions promise to play a greater (and complimentary) role in treating PTSD. Of course, the severity of many of these conditions will require more intensive traditional therapeutic interventions as many of the digital mental health apps are geared toward less acute conditions with a focus on meditation and wellness.
The tragedy here is that trauma can happen in an instant, but the treatment may take a lifetime. With traditional resources so constrained and offering uncertain outcomes, the role of psychedelics is at a minimum intriguing, and at best, could be a powerful approach to providing relief to those most acutely impacted.