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As the frequency of concussions, including traumatic brain injuries (TBI), grows, so does interest in finding an effective way to treat the condition – and psychedelics may be part of that answer.

The previous routine dismissal of concussions as short-lived and relatively trivial events has been replaced by claims that there is now a concussion crisis.

Quantifying the Issue

Doctors are seeing more concussion patients coming in for treatment every day from all walks of life.

One 2020 study found that between 2008 and 2016, 1.3 million people were diagnosed with a concussion, 10 million deaths and/or hospitalizations annually are directly attributable to TBI, and an estimated 57 million people have experienced TBIs.

A concussion can happen anywhere, anytime – falls, motor vehicle accidents, and assaults. Children, young adults, and older adults are at especially high risk for concussions and may take longer to recover, according to Johns Hopkins Medicine.

A concussion can cause a litany of problems, for example, headache, vomiting, nausea, trouble thinking normally, memory problems, dizziness, and vision problems. Researchers have also discovered that some people may be at risk for neurobiological depression and/or anxiety following a concussion.

The U.S. Department of Defense and the Veterans Affairs are both keenly interested in anything that can help with the thousands of TBIs they treat from injured warfighters.

The Defense and Veterans Brain Injury Center reported nearly 414,000 TBIs among U.S. service members worldwide between 2000 and late 2019. More than 185,000 veterans who use the Veterans Administration for their health care have been diagnosed with at least one TBI.

VA doctors are still hesitant about working with psychedelics, since they are government agencies, and most psychedelics are federally illegal Schedule 1 drugs. But they are beginning to see the light.

Research Pool Grows

At least five trials are underway or planned by a handful of government clinicians who see the potential in using psychedelic experiences combined with psychotherapy to treat post-traumatic stress disorder, substance abuse, and other conditions endemic among veterans of recent wars, according to an article in The New York Times.

Another veteran-related psychedelics-and-concussion project is underway by Heroic Hearts, a psychedelics-for-veterans support and advocacy group, working with the Imperial College of London to study the effects of psilocybin on head trauma and the psychological effects on military veterans. The project started in late 2021, using seven-day retreats in the Netherlands and Jamaica.

The need for help with concussions is accelerating discoveries with psychedelics. Researchers at Yale University are working on a clinical trial to investigate the effects of oral psilocybin in post-traumatic headache. Their 24 participants will be randomized to receive placebo, low-dose psilocybin, or high-dose psilocybin on two separate test days approximately 14 days apart. They will maintain a headache diary prior to, during, and after the treatments to document headache frequency and intensity, plus other symptoms. Blood samples will be drawn at various timepoints to measure levels of inflammatory peptides. The trial is expected to wrap up in July 2023.

And it’s not just psychedelics that offer hope for treating concussions. The University of Miami Miller School of Medicine researchers received $1.624 million in funding from Tassili Life Sciences, a company focused on psychedelic treatment research that is a wholly owned subsidiary of Braxia Scientific Company, to study whether using a pill form of cannabidiol and the psychedelic drug psilocybin effectively treats and possibly prevents symptoms of two conditions that commonly occur together: mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD).

More athletes are coming out with their own stories of treating their brain injuries with psychedelics, such as NHL player Daniel Carcillo, NFL player Kerry Rhodes, and UFC fighter Ian McCall.

Potential Treatment Options

TBI researchers are also looking at ketamine, ayahuasca, 5-Methoxy-N,N-Dimethyltryptamine (DMT), MDMA, and ibogaine, all of which may have a role in treating concussions.

Ibogaine is a recent addition to this list. It is one of the psychoactive indole alkaloids found in the West African shrub, tabernanthe iboga. It has anti-addictive properties and helps reduce dependence on a variety of abused drugs, including opiates, cocaine, alcohol, and nicotine.

Mind Cure Health (CSE: MCUR) (OTCQB: MCURF) (FRA: 6MH), a company developing technology to advance psychedelic-related treatments, announced that their bioinformatics platform, PsyCollage, has identified opportunities for ibogaine to support neuroregenerative pathways that could be pivotal in treating neuropathic pain and brain trauma.

Ibogaine is thought to repair and reset the brain’s reward system. It may stimulate the growth of new dopamine neurons, which further supports its therapeutic potential for neurodegenerative conditions such as Parkinson’s and Alzheimer’s disease.

Revive Therapeutics, Wesana Health, and Lobe Sciences are all working on psychedelics to treat TBI as well.

Revive Therapeutics in March, 2021, announced positive results of a pre-clinical study evaluating the efficacy of psilocybin in the treatment of mild traumatic brain injury in a rodent model of TBI. The study was conducted at the National Health Research Institutes.

Then in September, 2021, Lobe Sciences announced interim data from its preclinical research studies in established rodent models of mild traumatic brain injury/concussion and post-traumatic stress disorder using a combination of psilocybin plus N-Acetyl cysteine, a drug used by the body to build antioxidants.

But as with so many mental health and wellness research with psychedelics, there is much more to be done.

Data Bridge Market Research reports that the TBI treatment market will grow to $201.1 billion by 2029.

“Psychedelics may play a future role in treatment of brain injury through a variety of mechanisms,” another study concluded. “Though these are a novel class of drugs deserving close study, more data are necessary to prove their efficacy for treatment of brain injury, as historically many compounds have seemed promising in vitro, including likely hundreds of compounds thought to facilitate neuroplasticity and neuroprotection, but have not borne out in clinical trials.”

The post Doctors Look to Psychedelics to Address Concussion Crisis appeared first on Green Market Report.

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Ketamine’s use cases continue to grow across the country, from clinics treating mental health to law enforcement using it to subdue suspects (albeit with sometimes tragic results), making it appear to be a new wonder drug. It’s also effectively help drive the whole psychedelics industry forward.

Ketamine in low doses is an anesthetic used to sedate both humans and pets. It’s also been, and continues to be, a favorite of partygoers seeking a psychedelic high, called K, special K, super-acid, or cat valium.

It is also reportedly very hallucinogenic. People can experience unpleasant flashbacks even weeks after the drug has been eliminated from the body, according to one study.

But beyond anesthetic and recreational use, other indications include using ketamine as a regular treatment option for adult pain conditions such as complex regional pain syndrome (CRPS). It can be used for CPRS in young children as well, according to a study, and even to treat severe epilepsy for neonatal patients.

Recent clinical trials are looking at ketamine to treat alcoholism and other addictions. “In many cases, the use of ketamine has been shown to relieve symptoms of depression and PTSD so the effect of ketamine on pain relief, mental health benefits, and the social effects, such as improvement of quality of life, are all potential areas of study,” the CPRS study concluded.

The drug’s growing popularity for treating depression in particular is partly a result of it being listed as a Schedule III substance by the Drug Enforcement Administration (DEA) in 1999, and the approval of the prescription nasal spray Spravato (to be taken with an oral antidepressant) made with a nonhallucinogenic formulation of ketamine. It’s expensive – Spravato costs $729 for a two-spray dose.

Research demonstrates the benefits of ketamine over standard pharmaceutical methods of treating depression. One study found that standard antidepressants often take weeks to months to achieve their full effects, commonly resulting in increased risk for suicidal behavior.

But a single infusion of ketamine induced a rapid (within two hours) and sustained (1-2 weeks) effect in patients with treatment-resistant depression.

The legalities of using ketamine and doing ketamine therapy are still complex and vary state by state. For example, possession of ketamine (or any other Schedule III controlled substance) can get you one year in the county jail in California. Possession of 1,000 milligrams or more of ketamine in New York is a felony.

So for now, ketamine remains illegal to use without a prescription or during a surgical procedure under the care of a licensed professional.

There are loopholes being explored. Ketamine intravenous infusion therapy falls into a legitimate off-label use for mental health conditions not effectively treated by what’s on the pharmaceutical market today. As long as the health care provider in charge judges the infusion therapy to be ethical and not violative of safety standards, they may prescribe it accordingly.

There are more than 100 ketamine clinics and treatment centers in the U.S., with some estimates reporting even higher, clustered mainly on the coasts. Cost per infusion general ranges from $200 to $800, but costs can go as high as $2,000. The longer the duration for the infusion and the higher the dose, the more the infusion costs. Some patients reportedly go through dozens of infusions.

More research about the drug is encouraging to researchers, but it’s also sounding the alarm as sometimes contradictory results continue to roll in. Ketamine offers a “higher level of consciousness,” similar to LSD and psilocybin, according to one study.

But ketamine has been found in another study to be less efficacious than both LSD and psilocybin, because it doesn’t offer the same sort of therapeutic psychedelic experience as those substances do.

Bottom line: The mental health world is witnessing ketamine becoming a psychedelics phenomenon, and that’s not necessarily a good thing, according Dr. Jeffrey Lieberman, psychiatrist-in-chief of Columbia University Medical Center.

“Ketamine has proven a real boon to those with treatment-resistant depression,” he wrote in a 2017 commentary. “However, things have moved along at such an accelerated pace as to pose a concern – and, frankly, a real danger – to the field of psychiatry. This is a work in progress, and for clinicians to engage in this kind of reckless application and leaping ahead of evidence is very, very dangerous, in my opinion. I’m very sorry to have to say that it’s not just that people are being overzealous in their application of what they think might be a panacea, but it’s driven by the profit motive.”

Other psychiatrists and medical doctors also urge caution. A group wrote in a “consensus statement” published by the Journal of the American Medical Association: “While ketamine may be beneficial to some patients with mood disorders, it is important to consider the limitations of the available data and the potential risk associated with the drug when considering the treatment option.”

The post Ketamine Use Case Expands, But Concerns Persist appeared first on Green Market Report.

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The medical psychedelics decriminalization efforts are growing, with now 20 different states (or cities and counties within states) either decriminalizing or working on decriminalizing psychedelics. 

There have been pushbacks, with complaints that some decriminalization efforts include making them the “lowest law enforcement priorities,” a ruling that still effectively criminalizes psychedelics. That same ruling applied to the decriminalization of cannabis.

But one of the bigger pushbacks about cannabis was how the decriminalization effectively became the first step toward legalization of not just medical cannabis, but recreational cannabis as well—and that perhaps the current psychedelics decriminalization efforts are headed that way too. 

As various states continue to discuss medical legalization and decriminalization of cannabis, there is generally at least one holdup that says it will lead to recreational use, such as Tennessee state legislator, Rep. Sabi ‘Doc’ Kumar (R-Springfield).

And so it goes in psychedelics: In testimony for decriminalizing psychedelics in Maine in February, the director of the Maine Center for Disease Control and Prevention, Dr. Nirav Shah, cited concerns about the lack of input by state health officials on the regulatory oversight, which could allow psilocybin treatment centers to “function more like recreational use facilities rather than medical treatment facilities.”

Recreational Psychedelics

The Oregon Health Authority created the Oregon Psilocybin Advisory Board, with members from psychology, allopathic and naturopathic medicine, public health, and other professions, and appears to be expecting the federal government to ignore psilocybin use under the new law, as it has in states that have legalized the possession of marijuana, according to a viewpoint article in the Journal of the American Medical Association (JAMA). That could open the door to the recreational use of psychedelics.

But the development of the psychedelics legalization pathway is different than the cannabis legalization pathway. Though both cannabis and psychedelics had the same beginnings as recreational substances used in the U.S., psychedelics today is almost always about pure medical mental health treatment. 

Psychedelics are more powerful in their effect, and therefore need to be more controlled in their therapeutic use. Most of the clinical studies on psychedelics have been limited by small sample sizes, with difficulties in blinding given the subjective effects of psychedelics, and exclusion of participants with comorbidities, histories of drug use, and personal or family histories of psychotic disorders. “The extent to which findings like these may generalize to larger and more representative patient samples is unknown,” the viewpoint article stated. 

There are still too many unknowns about psychedelics that appear to transcend the effects of the cannabis consumption experience, with more concerns about casual use. For example, another article cited a study of 1993 psilocybin users who experienced “bad trips” reported that 62% characterized them as, among the 10 most challenging experiences in their lives, 10.7 percent reported having put themselves or others at physical risk, and 2.6 percent had become physically violent.

Ten percent of respondents reported symptoms lasting more than 1 year, with a small number of cases consistent with “enduring” psychosis.

So now here we are, in a new industry being developed that is, in many cases, following the legalization process of one of the only other DEA schedule 1 substance—cannabis—that has been legalized by various states.

$2 Billion Market

And as with cannabis, psychedelics startup entrepreneurs have been sensing a gold rush for years, and are lining up in much the same way as they did in the early days of cannabis legalization. The market for psychedelic substances is projected to grow from $2 billion in 2020 to $10.75 billion by 2027, a growth rate that may even outpace the legal US cannabis market.

But there’s a sense that investing in purely medical psychedelics is a safer bet, and that the lessons learned about the rollout of the cannabis industry, and its quick expansion into a recreational product, have been applied. “A lot of the early idealism of cannabis gave way to a race to be the biggest and fastest,” said Bryan Passman, co-founder, and CEO of Hunter-Esquire, a cannabis, and psychedelics business strategy company, speaking to Entrepreneur magazine. “It’s the very early days, but I do think the psychedelics industry as a whole is better set up for success simply because there are more regulatory and legal pathways, and more Ph. D.s and MDs, than in cannabis,” says Passman. “Companies are finding themselves in bed with investors with more scientific minds, versus capitalist minds. The scientific minds are users and I believe it makes them more conscientious, which will hopefully feed into the opportunity for psychedelics to be different.”

Still, there remains some confusion about where the psychedelics industry is now, where it is going, and how the cannabis industry has been and will continue to inform that direction. 

Rick Doblin, founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), speaking on a panel at the Harvard Law School about the future of psychedelics law, said that legalization follows medicalization, citing the changing voter views of marijuana: From solid support in the ‘60s to a backlash in the Carter and Reagan years, to a major upswing in 2013 after medical marijuana proved viable. 

He said that psychedelic drugs would require a similar trajectory, and it may take a while: “We think it’s going to require a decade of psychedelic clinics being rolled out, for people to hear about the positive experiences. We’ll have licensed legalization, I think, in 2035.” At which time, he suggested, you’ll be able to turn on the television and see psychedelics advertised like any other beneficial drug: “Ask your doctor if MDMA is right for you.”

The post Recreational Psychedelics Enters The Conversation appeared first on Green Market Report.

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Nutraceuticals have been getting a bad health and wellness rap for years. 

Most of the chatter is about them not being “real”; doctors ignore them in part because they have not gone through any FDA-approved clinical trials—even as their patients rave about the health benefits they get from taking them.

Now there’s a movement to team up nutraceuticals with psychedelics and apply the science developed around psychedelics to advance nutraceuticals as more credible health and wellness products. 

The two have been vectoring toward each other for years.

What is a Neutraceutical?

According to one study, a nutraceutical product may be defined as a substance that has a physiological benefit or provides protection against chronic disease. “Nutraceutic” is a term derived from “nutrition” and “pharmaceutics.” The term is applied to products that are isolated from herbal products, dietary supplements (nutrients), specific diets, and processed foods such as cereals, soups, and beverages that other than nutrition are also used as medicine. 

Nutraceuticals may be used to improve health, delay the aging process, prevent chronic diseases, increase life expectancy, or support the structure or function of the body. More recently, nutraceuticals received considerable interest due to their potential nutritional, safety, and therapeutic effects. 

Emphasis has been made to present herbal nutraceuticals as effective on hard curative disorders related to oxidative stress including allergy, Alzheimer’s disease, cardiovascular, cancer, diabetes, eye, immune, inflammatory, and Parkinson’s diseases, as well as obesity.

And there it is—the overlap of nutraceuticals and psychedelics, as both appear to be working in the same direction as complementary solutions to the same human health and wellness issues.

One company that is taking a shot at upping the rigor of clinical science of nutraceuticals while also working with psychedelic substance development is KGK Sciences, a subsidiary of Wellbeing Digital Sciences (NEO: MEDI) (OTC: KONEF) (FRA: SQ2) that opened their new clinical research center in London, Ontario in September. “We knew that the dietary supplement industry needed to have clinical trials behind the products because it was a new industry back in 1997,” Najla Guthrie, president and CEO of Wellbeing Digital Sciences and KGK Sciences, told Psychedealia. “It was a cottage industry back then, starting with people who made all kinds of outrageous claims about products without any science behind them,” she said. “So are nutraceuticals needing the same type of scientific rigor that is required for psychedelics? I’d say no. People have been using them for centuries. What we’re doing now is providing the data to say, yes, this actually works for this. Or this is actually safe in these quantities that you’re proposing.”

She said that psychedelics are different because of the psychotropic effects. “They need to go through the drug route for development, which has very stringent requirements of what needs to happen. You need the preclinical data, you need safety and toxicity data.”

Today, on the dietary supplement side, if it’s a new ingredient, for example, a dietary supplement maker also has to do some level of clinical trial work to verify the safety and efficacy of that product, in a similar fashion to the trials of MDMA, psilocybin, and ibogaine, she said. “I think there’s so much research going on in the psychedelic space, and there’s a lot of amazing new products on the nutraceutical that we are working on,” she said. “There’s a lot of really interesting crossover and connections that we can make between the two, and a lot of innovation is going to get us further along.”

She said that formerly skeptical doctors have become more informed about nutraceuticals today, specifically about which nutraceuticals have better science behind them and which don’t. “Doctors have to be informed because it’s a consumer-driven industry,” Guthrie said. “So the patient comes in and says, ‘Doc, I’m taking this, this and this. Is that going to affect any of the medications that you have me on?’ and ‘I want to take these because I know they make me feel better.’

That reworked skepticism from doctors is the same thing that is happening with psychedelics, she said. “I think what we really need to do for psychedelic drugs, though, is to make sure that we as an industry are responsible about how we bring these products to market, and that we’re responsible to make sure that they’re data-driven, that we’re responsible, that the policy that gets changed from a regulatory perspective is data-driven and scientifically backed.”

The work of KGK Sciences is now about 70 percent on nutraceuticals, with the rest of their development work in cannabis and psychedelics. “Psychedelics are an area that is going to skyrocket for us,” Guthrie said. 

Psilocybin

Researchers at KGK are currently doing a phase II clinical study with Halucenex, a life sciences company in Windsor, Nova Scotia, where they are going to look at the effects of a single dose of oral synthetic psilocybin medical products and the treatment of PTSD. The first patient is planned to be enrolled on October 11.

Another study that KGK is working on will examine the safety and efficacy of a microdose of oral synthetic psilocybin, to treat the cognitive and behavioral autism spectrum disorder symptoms in adults. “This has huge implications,” she said. “The preclinical data that we’ve seen so far in animals shows really positive results.”

The company is also looking at working with companies to combine selected nutraceuticals and psychedelics to address a number of different issues, and to enhance the mechanism of action of both.

KGK has other psychedelics studies for treating addiction, end of life, and chronic pain, she said.

More support for psychedelics and nutraceuticals working together comes from the American Herbal Products Association (AHPA), which chartered its own Psychedelic Plants and Fungi Committee in March to address issues related to the safe use and responsible commerce of lawfully marketed products derived from psychedelic plants and fungi. Elan Sudberg, CEO of Alkemist Labs, and the committee’s first chair said that, with the emergence of legal psychedelics being professionally used to address major mental health issues, and research finding significant benefits in that context, “it’s crucial that the category be developed with experience and deliberation. Given that AHPA’s mission is to promote the responsible and sustainable commerce of herbal products to ensure that consumers have informed access to a wide variety of safe herbal goods, it’s entirely appropriate that AHPA’s expertise be utilized to help that sector grow responsibly.”

The post The Marriage of Herbal Nutraceuticals and Psychedelics appeared first on Green Market Report.

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One of the biggest concerns for people who are considering taking psychedelics for their mental health is what they may have to endure as part of their treatment.

Facilitators or therapists will tell them they may experience ego dissolution, which is a compromised sense of self. They may witness mystical experiences with various frightening apparitions. Psychedelic therapeutics opponents even cite anecdotal reports of adverse effects of psychedelics to warn away anyone considering psychedelic therapy, even though they typically end within 24 hours.

What researchers are discovering is that psychedelics help rewire the brain, and the hallucinogenic aspect of psychedelics effectively disrupts activity within the brain’s neural networks to help develop stronger and more numerous connections between neurons.

Even the scary mystical experiences a patient endures from hallucinations are hypothesized to be instrumental in the lasting positive effects of psychedelics.

Right now, hallucinogenic medicines generally are not considered first-line treatments for mental illnesses, because many patients are reluctant to take them, or they have contraindicated co-morbidities or genetic predispositions, including vision or hearing impairment and learning disabilities.

But in an attempt to broaden the appeal of therapist-assisted psychedelics, a number of companies are engineering out the hallucinogenic aspect of the psychedelic experience.

One company doing that is MindMed (Nasdaq: MNMD) (NEO: MMED), a clinical stage biopharmaceutical company developing psychedelic-based products to treat brain health disorders. MindMed is developing 18-MC, a non-hallucinogenic derivative of ibogaine to treat opioid use disorder.

Delix Therapeutics (Nasdaq: DELIX) and Mindset Pharma (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) also are pursuing research and development of non-hallucinogenic psychedelics, categorizing them as next generation psychedelic compounds.

Researchers at the University of North Carolina School of Medicine are working to find psychedelics-derived medications that effectively and rapidly treat depression and anxiety without major side effects such as hallucinations, weight gain, sleepiness, and dry mouth. So far, rapidly acting drugs without potentially disabling side effects for depression, anxiety, and addiction don’t exist, not even as experimental compounds for use in animals, according to researchers.

In June 2020, the UNC researchers received a $26.9 million grant from the Defense Advanced Research Projects Agency (DARPA) to do their research.

The UNC team will use new structural biology and computational approaches to create these new medicines.

“Although drugs like ketamine, and potentially psilocybin, have rapid antidepressant actions, their hallucinogenic, addictive, and disorienting side effects make their clinical use limited,” Dr. Bryan Roth, lead researcher on the DARPA-funded project, said in a report on the UNC website. “Our team has developed innovative methods and technologies to overcome these limitations with the goal of creating better medications to treat these neuropsychiatric conditions.”

As the psychedelics industry evolves, with the real possibility of an FDA-approved psychedelics-derived drug available by 2024, the search for a non-hallucinogenic method of using therapeutic psychedelics is heating up.

Researchers also found that psychedelics are potent psychoplastogens, which are molecules capable of rapidly rewiring the adult brain. The advent of non-hallucinogenic psychoplastogens with anti-addictive properties raises the intriguing possibility that hallucinations might not be necessary for all therapeutic effects of psychedelic-based medicines.

One of these non-hallucinogenic psychoplastogens, tabernanthalog, appears to have long-lasting therapeutic effects in preclinical models relevant to alcohol and opioid addiction, according to the study.

Tabernanthalog is a water-soluble, non-hallucinogenic, nontoxic analogue of ibogaine that can be prepared in a single step. Another study found that, in rodents, tabernanthalog promoted structural neural plasticity, reduced alcohol- and heroin-seeking behavior, and produced antidepressant-like effects.

The study reported that researcher’s work demonstrated that, through careful chemical design, it is possible to modify a psychedelic compound to produce a safer, non-hallucinogenic variant that has therapeutic potential.

The work on engineering non-hallucinogenic psychedelics comes down to balancing access for more patients, with a careful risk/benefit analysis.

Rick Doblin, founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), said during a podcast that he thinks MDMA can be a helpful therapeutic for someone suffering schizophrenia when used in a very controlled situation, and that some of the work at places like Johns Hopkins on psilocybin is too exclusionary of patient’s preexisting conditions and therefore too cautious.

But he agreed that psychedelics are not for people who don’t want to take them. “People have to be willing to go through the difficult parts of this (psychedelics therapy). And if they are not willing, then it’s not for them.”

The post Researchers Seek to Remove ‘Trip’ as Popularity of Psychedelic Treatments Grows appeared first on Green Market Report.

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Trying psychedelic therapeutics can be a profound life-changing experience. Most participants in clinical trials report immediate relief from the issues that brought them to try psychedelics in the first place, whether it is understanding what causes their depression, how to deal with PTSD or just coming to terms with the demons deep within their consciousness.

But there’s a catch.

Psychedelic therapy requires a leap of faith by participants about what is going to happen to them, even in a controlled clinical setting. Psychedelic therapy can be challenging, with troubling visions and thoughts of feeling “dead” – even visualizing your death – or even scarier scenarios.

According to one research article, some N,N-Dimethyltryptamine (DMT) clinical participants reported finding themselves in an alien environment surrounded by entities that seemed to have hostile intentions: “I was shown a frightening entity and within its tentacles was my human self. Not only me but many others as well. It was unreal. It was as if it were feeding on our souls.”

All classic psychedelics currently in clinical trials – such as LSD, MDMA, DMT and psilocybin – involve the participant seeing mystical images, hearing strange sounds and, in some cases, feeling as if they died.

The whole experience can be overwhelming if not carefully designed for the specific set and setting, with the proper therapist assistance before and after the experience. That is why harm reduction techniques, and getting informed consent, are critical tools for clinicians to use today.

Now researchers have come up with a way to compare near-death experiences (NDE) to psychedelics-imagined “death” experiences in an effort to learn more about both.

A recent study demonstrated potential similarities between both DMT experiences and NDE, including the subjective feeling of transcending one’s body and entering an alternative realm, perceiving and communicating with sentient “entities” and themes related to death and dying.

The study reported that commonly described features of the DMT experience include a feeling of transcending one’s body and entering into an alternative “realm”, an acoustic perception of a high pitched “whining/whirring” sound during the onset of the experience, perceiving and communicating with “presences” or “entities,” and reflections on death, dying and the afterlife.

The reported vividness of both subjective experiences have led to NDE experiencers and DMT users alike describing the states they enter as “realer than real.”

Another report found that medical unconsciousness was significantly more prevalent among the DMT group relative to the other classic psychedelic drug groups.

But 21% of the NDE group went further than reporting just medical unconsciousness. They reported that they were actually clinically dead (i.e., cessation of breath, heart function) during the experience. Another 11% reported that a medical professional confirmed them to be clinically dead at the time of the experience, a much more profound experience than with classic psychedelics, where less than 1% of any drug group reported clinical death at the time of the experience.

The NDE experience has been associated with long-term positive changes in psychological well-being and related outcomes, such as:

• Greater concern for others
• Reductions in distress associated with the prospect of dying
• Increased appreciation for nature
• Reduced interest in social status and possessions
• Increased self-worth

There were similar long-term positive changes with classic psychedelics. For example, psilocybin was found to reduce the psychiatric stress of dying. One study found that psilocybin-facilitated therapy may enhance the psychological, emotional and spiritual well-being of patients suffering with life-threatening cancer.

These new studies about NDE and psychedelics build on the findings that psychedelics researchers have known for years. In 2016, Roland Griffiths, professor in the Departments of Psychiatry and Neurosciences at the Johns Hopkins University School of Medicine, did a series of studies on psilocybin and people with a fatal cancer diagnosis facing end-of-life distress.

His research found that the psilocybin experience enabled a sense of deeper meaning and an understanding that, in the largest frame, everything is fine and there is nothing to be fearful of.

Griffiths described what he found out in an article published in Scientific American: “There is a buoyancy that comes of that which is quite remarkable. To see people who are so beaten down by this illness, and they start actually providing reassurance to the people who love them most, telling them ‘It is all okay and there is no need to worry.’ When a dying person can provide that type of clarity for their caretakers, even we researchers are left with a sense of wonder.”

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The decriminalization of psilocybin and other psychedelics decriminalized quickly has become one of the defining efforts of the psychedelics renaissance this year. It began in Denver in May 2019, and it’s been slowly picking up speed since.

It’s also evolved. More of the decriminalization efforts taking place now aren’t just about psilocybin. It’s becoming more about entheogenic substances – better known as psychoactive plant substances. For example, Initiative 81, the Entheogenic Plant and Fungus Policy Act of 2020, passed by overwhelming voter support in Washington DC in November 2020.

The decriminalization movement is setting up a somewhat confusing structure for the future of psychedelics. Cities are establishing their own psychedelics rules, while the states where some of these cities are located often are looking to set up their own programs.

And there is a race shaping up to be the first state to legalize recreational use of psilocybin, as both Colorado, Oregon and Washington begin to explore the limits of lawmakers’ tolerance for broader action balanced against what their constituents have already approved.

Let’s take a look of the hotspot locations where decriminalization is under serious consideration to help understand what is going on now.

City: San Francisco – The San Francisco Board of Supervisors just voted to decriminalize entheogenic plants, including a “full spectrum of plants, fungi and natural materials that can inspire personal and spiritual well-being, can benefit psychological and physical wellness, and can reestablish human’s inalienable and direct relationship to nature.”

The resolution explicitly spells out that it is decriminalizing psilocybin, ibogaine, ayahuasca and mescaline. There will still be a penalty for possession and use, but it will be among the “lowest priority” for arrest, according to the Sept. 6 resolution. Oakland (via Resolution 87731CMS in June 2019) and Santa Cruz (via Resolution NS-29,867 in September 2021) preciously passed decriminalization measures as well.

State: California – The state legislature already started the conversation around the decriminalization of personal possession of small amounts of seven psychedelic substances for adults through California State Senate Bill No. 519, introduced by Senator Scott Wiener (D-San Francisco) in 2021. That bill is currently pending before the California Legislature. SB 519 is co-sponsored by combat veteran service organizations Heroic Hearts Project and Veterans Exploring Treatment Solutions (VETS). How the recent San Francisco decriminalization movement will affect the state’s actions is still a question that legislators are discussing, but the support of Heroic Hearts Project and VETS is viewed as a serious boost to any of its future legislative actions.

City: Detroit – Detroit voters overwhelmingly approved Proposal E, a citizen’s ballot initiative in November 2021, to decriminalize the possession and therapeutic use of entheogenic plants, including psilocybin, peyote and ibogaine. Detroit became the second largest U.S. city to decriminalize the possession and therapeutic use of entheogenic plants.

State: Michigan – The Michigan Decriminalization of Psilocybin Mushrooms and Other Plants and Fungi Initiative may appear on the ballot in Michigan as a citizen-initiated state statute in November 2024. Separate from that initiative, the state legislature is considering SB 631, introduced by Senator Jeff Irwin (D-Ann Arbor) and Adam Hollier (D-Detroit) last September, that would decriminalize DMT, ibogaine, mescaline and psilocybin. Ann Arbor decriminalized entheogenic plants in September 2021, with the Washtenaw County Prosecutor’s Office issuing a detailed directive discussing the context, rationale and public policy supporting its decision to support and adopt the city’s policy. Several other communities are also undertaking decriminalization efforts, including:

• Grand Rapids
• Detroit suburbs of Hazel Park and Madison Heights
• The state’s capital city, Lansing, and neighboring college town East Lansing
• Upstate tourist destination Traverse City
• Ypsilanti, which neighbors Ann Arbor
• Flint

City: Seattle – In October 2021, Seattle became the largest city (population 762,687) to decriminalize psychoactive plant substances with a resolution unanimously approved by the city council. That measure declared that the investigation, arrest and prosecution of anyone engaging in entheogen-related activities should be among Seattle’s lowest law enforcement priorities. It also expressed the council’s support for full decriminalization.

State: Washington – Seattle therapist Leo Russell submitted ballot initiative measure number 1886 in February to essentially legalize psilocybin, going a step beyond similar legislation passed in Oregon in November 2020 (Measure 109).

The latest initiative would allow licensed persons to provide psilocybin products and services to persons 21 and older and require state agencies to license and regulate the manufacture, sale and use of psilocybin. Under 1886, anyone over 21 can purchase a microdose of psilocybin after a brief preparation session with a facilitator and then take it with them for consumption at their leisure rather than sitting in a pseudo-clinical setting being monitored before and after the psilocybin dose has worn off before being allowed to leave the facility where the purchase was made, as specified in Oregon’s Measure 109.

Washington’s 1886 has been viewed as one of the more progressive – and controversial – rules about selling and consuming psychedelics in the country.

Several other states are also undertaking conversations in this vein. Colorado is in the hunt to go all legal through the whole state with a flurry of initiatives this year, including Initiative 58, which would allow individuals over 21 to obtain access to “natural medicines” at “healing centers.” The term “natural medicine” includes DMT, ibogaine and mescaline (excluding peyote). On July 21, 2022, Initiative 58 received enough signatures to qualify for the 2022 general election ballot.

Connecticut, Florida, Georgia, Hawaii and at least 17 other U.S. states also are stepping up their legislatures’ discussions about decriminalizing various psychedelics. Massachusetts is banking on the decriminalization efforts of four of its cities to drive its full state efforts. Other states, such as Utah, are still in the earlier stages of investigation.

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Any time there’s a nascent industry in the midst of a growth surge, that industry will begin to attract more attention from less scrupulous business fringes looking to capitalize on the hype. The psychedelics industry is at this point now, with these players jumping on buzz created by articles in such esteemed publications as the The New York Times, The Wall Street Journal, Fortune and The Economist.

These entities do not really care if it’s illegal to sell the product or not. They thrive on risk. The black market from decades ago – for magic mushrooms and MDMA in particular – is still thriving with a familiar customer base using old-school distribution and purchasing methods.

Now there is also a newer customer base ready and willing to buy it, people who actually need it to treat their mental health. The people selling and distributing the product see this as a big opportunity, even as they do their best to dodge the rules, reinterpret the laws and pay the penalties.

It’s a very lucrative market; the risks are worth it.

With this new customer base looking for medical help, it’s also become a weirdly illicit-for-the-good-of-all market.

Consumer demand is picking up in part because Big Pharma is still, for the most part, sitting on the sidelines as the psychedelics industry builds momentum. Big Pharma may even be bailing on trying to find new drugs to treat mental health conditions, mostly because of the costly research into central nervous systems pharmaceuticals – even though those drugs have traditionally represented their largest sources of revenue.

In fact, one study pointed out that Big Pharma’s drug discovery is at a near standstill for treating psychiatric disorders such as schizophrenia, bipolar disorder, depression and common forms of autism.

“Despite high prevalence and unmet medical need, major pharmaceutical companies are deemphasizing or exiting psychiatry, thus removing significant capacity from efforts to discover new medicines,” according to the study.

That leaves a growing gap to fill for both legitimate psychedelics providers and the unscrupulous players selling psychedelics who mostly do their business on the internet and can knowingly provide psychedelic formulations that may or may not be the real thing.

Some counterfeit drugs available on the internet have no active ingredient and may have any number of harmful ingredients, including bacteria-laced water, toxic yellow paint, floor wax, colored dye, powdered cement, boric acid and antifreeze.

Today, you can buy LSD on the darknet with bitcoin, sent to an anonymous P.O. box. Until the middle of 2021, you could have bought liquid magic mushrooms sold by six guys who got caught operating in the darknet under the moniker Tripwithscience after making millions of dollars.

And the sudden popularity of N,N-Dimethyltryptamine (DMT) from stories about heavyweight champion boxer Mike Tyson’s experience has created a surge of interest in obtaining this powerful psychedelic over the internet.

U.S. Customs and Border Protections seized more than 635 pounds of DMT in Memphis in March. (One dose is 40-100 milligrams. One pounds is equal to 453,592 milligrams.)

Customs agents reported in a press release about the seizure that DMT, which was previously known to only certain societies in ritual shamanic practices, can now be found all over the internet in articles, blogs, message boards and even a Netflix documentary. Extraction methods can easily be found online too.

“Express consignment allows the delivery of DMT-containing bark to the front door of virtually anyone in the U.S. Couple that with some online extraction instructions, the recommendation of a popular podcaster, and you’ve got the ingredients for possible chemically induced schizophrenia,” Michael Neipert, Memphis Area Port Director, said.

When it comes to magic mushrooms, there are literally hundreds of businesses with websites selling them. But beware: Some are just selling kits, some are selling just spores, and some are using the word “magic” just to get you to click in. Finding the actual psilocybin mushroom for sale (illegally) on the internet takes a deeper dive.

But as more cities work on decriminalizing psilocybin policies – including Ann Arbor, Michigan; Denver; Oakland, California; and Seattle, with more states and municipalities on the way – more underground entrepreneurs are getting in the game, boldly selling it outright through pop-up markets and storefronts, such as the Coca Leaf Café mushroom dispensary in Vancouver, British Columbia, which also sells LSD tinctures and DMT vape cartridges.

According to an article in Bloomberg, industry insiders report the rise of community circles where psychedelics are administered by underground healers, as well as pop-up farmers markets and “seshes,” covert events where attendees pay an entry fee and are able to purchase magic mushrooms directly from growers.

“There is a lot of clandestine investment in currently underground or gray-market areas,” says Ismail Ali, director of policy and advocacy at the Multidisciplinary Association for Psychedelic Studies. “Decriminalization provides a level of protection for behaviors that are already occurring.”

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There is a growing need for more therapists, more clinicians and more researchers in the psychedelics industry, so several academic institutions around the world are heeding the call in an effort to quickly build a psychedelics workforce.

There are a reported 306 academic institutions around the world working on 628 psychedelics projects – 37 at Yale alone – with many of them including their project research in the student coursework as well.

Much of the research today is being done at stalwart academic institutions, such as Johns Hopkins’ Center for Psychedelic and Consciousness Research and New York University’s Center for Psychedelic Medicine, each with their own specific psychedelics study groups featuring some of the top mental health researchers in the world and developing more programs as the needs of the industry grow.

For instance, the UC-Berkley Center for the Science of Psychedelics will do their own research using low-dose psilocybin functional MRI experiments to obtain a deeper understanding of the neural correlates of the psychedelic experience. This study protocol received Food and Drug Administration (FDA) approval in January and the campus’ Institutional Review Board approval in May. They plan to enroll the first human subject volunteers this fall, depending on Drug Enforcement Administration (DEA) and Research Advisory Panel of California approval.

Stanford University in Palo Alto, California, is also getting deeper into psychedelics studies. The institution has offered an “Introduction to Psychedelics” course since 2018. This course tracks ongoing and developing clinical applications and scientific investigations of psychedelics and psychedelic-assisted treatments. Neuroscientific, clinical and psychological perspectives are discussed in the course, as well as the historical, legal, and cultural aspects of psychedelic medicine, according to the program’s website.

Others university psychedelics courses and training programs of note include:

• The Center for Psychedelic Therapies and Research at the California Institute of Integral Studies in San Francisco expects to train 1,125 psychedelic therapist graduates over the next three years. Its 2022 psychedelics therapist curriculum offers 150 total hours of instruction, including 120 hours of in-class learning (online and/or in-person) and 30 hours of individualized learning, mentor consultations and online video instruction.
• Boulder, Colorado-based Naropa University’s Certificate in Psychedelic-Assisted Therapies is a new, 10-month, 200-hour contemplative-based professional training program featuring a hybrid delivery of online and intensive retreat-based learning. Trainees will receive education in essential aspects of psychedelic-assisted therapy, trauma-informed care and spiritual integration.
• Ohio State University in Columbus is offering a new undergraduate course on psychedelics beginning this fall through the Department of Plant Pathology. “Psychedelic Studies: Neurochemistry, Plants, Fungi, and Society” is a comprehensive examination of the growing psychedelic studies field, including the relevant chemistry, ethnobotany, history, neurobiology, psychology and emerging policy options.

Beyond Educational Programs

While this expansion is exciting on its face, it’s not just the educating or training about the science of psychedelics that’s important. It’s about helping students spread the word about the value of psychedelics as a new mental and health wellness therapy.

The University of California-Berkeley Center for the Science of Psychedelics, for example, offers a Ferriss-UC Berkeley Psychedelic Journalism Fellowship for up to 15 reporting scholarships of $10,000 per year. The awards are intended to cover reporting costs and living expenses during the course of the project.

Reporting grant applicants need to submit a well-researched and compelling story pitch, three published or aired work samples, a resume and two letters of reference. A letter from a media outlet expressing interest in publishing or airing the story also will improve the chances of receiving a grant.

Fellows will be chosen by a panel of working editors and journalists.

The fellowship encourages journalists exploring the field to really dig into what is going on, reporting in-depth print and audio stories on the science, policy, business and culture of psychedelics.

The fellowship wants to establish and nurture a new generation of journalists covering the frontlines of psychedelics, according to the website information. “We’re looking for big, underreported, narratively compelling stories placed in rich political, economic, scientific and cultural contexts.”

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Among the four Food and Drug Administration (FDA) pathways for developing new drugs faster are Fast Track, created in 1997, designed to expedite the review of drugs to treat serious conditions and fill an unmet medical need; and Breakthrough Therapy, created by the FDA in July 2012, a process designed to expedite the development and review of drugs that are intended to treat a serious condition, where “preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).”

There have been no psychedelic compounds listed on the FDA’s fast-track approval list (but oxycodone made the list in 2016), and just a few listed on the FDA’s breakthrough therapy list, such as the Compass Pathways’ (NASDAQ: CMPS) psilocybin therapy for treatment-resistant depression in October 2018, and the Janssen Pharmaceuticals’ Spravato in March 2019.

All four FDA expedited drug development pathways are designed to overcome the problems of the long process of drug development, in part fueled by the AIDS epidemic when researchers had called for quicker review and development of drugs by the FDA.

In the 1960s and 1970s, clinical development of a new compound through marketing approval took respectively 7.9 years and 8.2 years, on average, according to one study.

Real World Evidence

While the development process is designed to ensure efficacy and safety, there is a new and growing acceptance of a new process of advancing drug development based on the rapid accumulation of data, which may soon be working with the randomized clinical trial (RCT) process—it’s called real-world evidence, or RWE.

The FDA promoted the use of RWE for a faster pathway to developing Covid vaccines beginning in September 2021 in a process that continues today.

Another example of RWE effectiveness was demonstrated in a recent study of the outcomes of ketamine from patients treated in 178 participating independent community ketamine practices across the U.S.—a setting that offers significantly different outcomes compared to patients in randomized trials.

The outcomes were measured on 9,016 outpatients with symptoms of depression who received ketamine intravenous therapy (KIT) between 2016 and 2020.

It was the largest published analysis to date examining the real-world effectiveness of a standard KIT induction protocol for depression using data from patients treated at community clinics across the United States.

One of the critical findings of the study is that a richer data set from RWE can form the basis of predictive models that directly inform clinical care. One example is how data about how medications, taken daily or as adjuncts to KIT, can modify the response. “More broadly, point of care data collection and personal sensing streams (e.g. actigraphy, or “wearables”) can establish links between self-report measures and functional health outcomes,” the study reported.

So RWE can help inform clinical care going forward. But what is the relationship now between real-world evidence and clinical trials?

The outcomes of RWE today usually get a lower credibility assignation by researchers working on RCTs. But RWE research is a practice that does not need to be done like a random clinical trial research for it to be reliable, according to another study.

Some of the advantages of RWE include less time and cost compared to RCT; research that can’t be done with RCT, such as safe research on high-risk groups; rapid access and easier information and data retrieval; and more.

The FDA sees the advantages and published draft guidance for working with RWE in September 2021. According to the FDA, RWE can be generated by different study designs or analyses from randomized trials, including large simple trials, pragmatic trials, and observational studies—all built on such real-world data (RWD) as electronic health records, product and disease registries, patient-generated data including in-home use settings, and data gathered from other sources that can inform on health status, such as mobile devices.

As more RWD is collected, RWE is being gradually expanded, with a developing need to be more structured and use the new silos of health data being generated every day. RWE and RCT research are not in a mutually competitive relationship, a study noted. “Presently, RWE research cannot substitute RCT research. However, RCT research, bestowed the highest reliability, and RWE research, perceived to reflect the actual clinical aspect, can be proven to share a mutually supplementary relationship to become the most powerful resource in evidence-based medicine.”

Today, as spelled out in a “Forbes” article by Dr. Dan Riskin, the founder of Verantos, health systems, insurers, and pharmaceutical firms have all created RWE divisions. Insurance companies use RWE to analyze whether high-cost therapies provide sufficient benefit.

But there are still many questions to answer. For example, would an identical RCT trial and an RWE study reach the same conclusions? The FDA is looking into that in more detail, hoping to make RWEs more valid by conducting additional RCT/RWE trial emulations to add to the ten already done.

Meanwhile, progress on RWEs for psychedelics research continues. Compass Pathways is searching for an RWE manager as it further investigates the process. And one company that hopes to make headway in using RWE for developing psychedelics is Albert Labs in British Columbia. “RWE studies are a much faster and vastly less expensive way to conduct and take medicine through regulatory approval to commercialization compared to RCT trials, as evidenced in bringing Covid 19 vaccines to market,” said Malcolm Barratt-Johnson, chief medical officer for Albert Labs in a blog featured on their website.

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When a psychedelic substance gets to Phase 3 trials, like the one completed by the Multidisciplinary Association for Psychedelic Studies (MAPS) with MDMA in August 2021, there is a general sense of relief. It’s been a long journey from Phase 1 for most substances in a clinical trial process—up to four years for Phase 3 alone in some cases. And only 33 percent of experimental drugs move from Phase 2 to Phase 3.

But getting to Phase 3 signals an extra red alert for any psychedelic company working the process to get Food and Drug Administration (FDA) approval.

According to an investigative article in the Journal of the American Medical Association (JAMA) Internal Medicine, Phase 3 clinical trials provide the highest level of evidence that an experimental treatment is safe and efficacious. But many of these trials for investigational or experimental drugs like psychedelics, which typically involve large numbers of patients, and require substantial investment on the part of participants, investigators, and sponsors, fail at this stage. 

Only 25 to 30 percent of experimental drugs are approved by the FDA at this stage, and move out of Phase 3 to Phase 4 trials.

Using public sources and commercial databases covering drugs and biologics that started trials between 1998 and 2008, the investigative article reported that roughly half of investigational drugs entering late-stage clinical development fail during or after pivotal Phase 3 clinical trials, primarily because of concerns about safety, efficacy, or both. Results for the majority of studies of investigational drugs that fail are not published in peer-reviewed journals—just 8 percent, according to the JAMA investigative article, demonstrating a lack of information sharing that could cause other trials to waste time and resources if their trials use similar methodologies.

For psychedelics specifically, there is historical context for problematic clinical trials. Research on psychedelic drugs in psychiatry in the 1950s and 1960s was abandoned for a number of reasons, according to a research paper published by the National Institutes of Health (NIH). 

A major factor was that clinical research on psychedelic drugs was caught up in the tighter regulation of pharmaceutical research after the Thalidomide disaster in 1963. (Thalidomide was used to treat nausea in pregnant women, but was later discovered to create severe birth defects.)

Psychedelic drugs also presented special challenges for randomized, placebo-controlled clinical trials in the 1970s that were not as positive as the claims made by their advocates in the 1950s and 1960s. Clinical research became more difficult after 1965 when Sandoz ceased providing psychedelic drugs for research, and their nonmedical use was prohibited in 1970.

But, contrary to the usual narrative, the demise of psychedelic drug research was not solely due to the “War on Drugs.” The NIH research paper said that the demise of psychedelic research came about in part because of the pharmaceutical industry’s lack of interest in funding clinical trials.

All that changed around 2000, when psychedelic clinical trials started up again and, since then, have gained momentum especially over the last few years.

Now, there are 111 psilocybin clinical trials in some stage of development, the majority of them announced or begun between 2019 and 2022; 117 clinical trials with MDMA, with 17 announced or begun in 2022 alone; and 30 clinical trials of LSD.

But to be sure, there are still clinical trial difficulties. One recently withdrawn psilocybin study was ended because of violations of good clinical practices, or GCP. These could be violations of getting informed consent, adherence to protocol, or reporting of serious adverse events during the trial.

Another psilocybin study was withdrawn because the sponsor of the study changed. The study will be released, managed and registered by another institution who will be acting as a responsible party, according to the trial record.

There are a host of other reasons that a psychedelics clinical trial was terminated, including staff turnover, lack of funds, and insufficient patient population for study enrollment. 

Clinical trials have also failed in general because human subjects not responding to the drug the way that animal models do, or because of an insufficient understanding of how the investigational product interacts with the body.

Unexpected results from clinical trials can be devastating. One example: When Compass Pathways (NASDAQ: CMPS) announced their Phase 2b clinical trial with psilocybin for treatment resistant depression in November, 2021—the largest randomized, controlled, double-blind psilocybin therapy study ever completed.

The main issue? 12 patients out of 233 reported treatment-emergent serious adverse events (TESAE) that included suicidal behavior, intentional self-injury, and suicidal ideation.

The Compass Pathways stock declined significantly—as did some other psychedelic companies as news of the trial results rippled through the industry. Compass Pathways’ stock decline from the results of that September, 2021 trial continued through 2022 (though its showing signs of recovery today).

Psychedelics is helping drive more innovation when it comes to clinical trials. There are new ideas emerging in clinical trial structure for psychedelics. The FDA developed the “fast track” process to facilitate development and expedite review of drugs to fill an unmet need, such as psychedelics for PTSD. 

And there is a fairly new concept from the FDA’s critical path initiative in 2006 called the adaptive design clinical trial, defined as a design that allows modifications to the trial and/or statistical procedures of the trial after its initiation without undermining its validity and integrity.

The purpose is to make clinical trials more flexible, efficient and fast. 

Due to the level of flexibility involved, these trial designs are also termed as “flexible designs.” It is being used now by MAPS in their Phase 2 trials. That kind of design is common for drugs with limited investment (either because they are being developed by nonprofits, because they have limited revenue potential if approved, or for rare conditions).

Recent policymaking aimed at stimulating pharmaceutical innovation has focused on allowing drugs to be approved on the basis of smaller data sets, according to the JAMA investigative article. Some commentators have proposed waiving the need for phase 3 testing, although others

have responded that approval before rigorous study could worsen health outcomes by leading to widespread use of toxic or ineffective drugs that would have otherwise been shown to

have failed. “As many investigational products fail in late stage development because of inadequate efficacy or safety, our findings suggest that additional efforts to promote drug

development should be directed at improving the validity of preclinical models for use in translational research and increasing the number of innovative products entering trials,” the research article concluded. “The timely publication of trial results for all investigational agents,

including those that fail in late-stage clinical development, is imperative.”

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