Biotech Companies Can Support the Crypto Market
2023.02.08 13:02
Biotech Companies Can Support the Crypto Market
By Kristina Sobol
Budrigannews.com – Investors are keeping a close eye on the number of biotech companies working with psychedelics this year because the once-controversial substances are back in the spotlight promoting their benefits for mental health and uniting lawmakers across party lines at the United States Capitol.
Although the American government has built-in checks and balances, even a Congress that is in agreement cannot direct drug policy on its own, the category’s future may see significant legal gains in 2023.
Cory Booker, a Democrat from New Jersey, and Brian Schatz, a Democrat from Hawaii, wrote a letter in May 2022 that urged the Food and Drug Administration (FDA) and the National Institutes of Health to investigate the therapeutic use of psychedelics. Republican Representatives Dan Crenshaw of Texas and Matt Gaetz of Florida had also pledged their support for the study of psychedelics by the end of the summer.
The “Breakthrough Therapy Designation” (BTD) had already been established by the FDA by 2012, making it possible for researchers to conduct trials of otherwise illegal drugs that may have undiscovered medical benefits. In 2017, MDMA and psilocybin received their first BTD designations, respectively. Psychotherapists can now use psilocybin to treat patients in Oregon.
The persistent, unlikely bipartisan union is inspiring increasingly bullish sentiments among psychedelics firms and their investors as lawmakers from both sides of the aisle argue about psychedelics on the federal level and use their power to earmark funds for research.
However, do not attribute it to the “Age of Aquarius.” Support for veterans is the driving force behind cooperation regarding these drugs, in addition to the potential healing benefits.
At least 6,000 combat veterans with post-traumatic stress disorder took their own lives in 2022 alone, and Representative Alexandria Ocasio-Cortez proposed an amendment to the 2023 National Defense Authorization Act (NDAA) in July 2022 that would require the Department of Defense to investigate psilocybin and MDMA in addition to cannabis as potential treatment options.
House Representative Dan Crenshaw, a former Navy veteran, offered a nearly identical amendment to the NDAA, focusing instead on the psychedelics ibogaine and 5-MeO-DMT. Ocasio-Cortez told Bloomberg, confirming that her office had spoken with Crenshaw’s, that “they are, I would argue, kind of collaborative amendments in a way.”
At a panel in August 2021 with Rick Doblin, executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), and veteran Jon Lubecky, who has benefited from MDMA therapy, Crenshaw had previously expressed support for MDMA research.
The Bitcoin (BTC)-rich Pineapple Fund contributed $5 million and assisted in raising $4 million more to support MAPS’ $26 million push. MAPS was the first pharmaceutical company to secure a BTD for MDMA. Meanwhile, four days following Ocasio-Cortez’s appearance on the panel in 2021, Crenshaw cast a vote in opposition to the psychedelics bills that were introduced in 2019.
In the summer of last year, Crenshaw and Ocasio-Cortez collaborated on two amendments, both of which were approved by voice vote shortly after being presented. Lubecky stated, “It’s hard to fight against it if AOC [Ocasio-Cortez] and Crenshaw can agree.” The NDAA has been approved by the house and is now up for debate in the Senate.
An identical NDAA amendment to Ocasio-Cortez’s was also presented by Representative Matt Gaetz, who was on the House Armed Services Committee at the time, but it was silently rejected.
The Congressional Psychedelics Advancing Clinical Treatments (PACT) caucus was established by Michigan Representative Jack Bergman and California Representative Lou Correa in November 2022 to take things to the next level. According to Correa’s statement to Cointelegraph, PACT is a bipartisan think tank that will investigate “how we as Congress can support further research into clinical applications.” PACT will not support the decriminalization of crime.
Correa recalled, adding, “During my time in Sacramento, I met veterans who were calling for access to cannabis rather than being prescribed opioids to treat their visible and invisible wounds from the battlefield.”
During my time working on cannabis, I’ve witnessed a significant shift in public opinion as more and more research has been conducted. This seems like a natural next step given the promising but still very little research into psychedelics’ clinical applications.
In the same month, Senators Booker and Rand Paul filed the Breakthrough Therapies Act, which would ask the Drug Enforcement Administration (DEA) to reclassify current and future drugs that the FDA had given the Breakthrough Therapy Designation for from Schedule I to Schedule II, making this the first amendment to Nixon’s Controlled Substances Act since it was passed in 1970.
Paul told Cointelegraph that the move will “ease researchers’ ability to conduct studies that can lead to breakthrough therapies to treat patients battling serious and life-threatening conditions,” and that it will “streamline the registration process for breakthrough therapies currently restricted by outdated drug classifications.”
As a researcher at the James J. Peters VA Medical Center, which is affiliated with Mount Sinai, Dr. Rachel Yehuda has studied post-traumatic stress disorder (PTSD) for more than 35 years. Even though MDMA and psilocybin are still Schedule I substances, she has been researching the potential of psychedelics to treat veterans with the condition since 2019. Yehuda met Doblin in 2018 at Burning Man, shortly after the FDA approved MDMA with BTD. Since then, a BTD has been granted to other pharmaceutical companies, including Compass Pathways, which is owned by Peter Thiel, and the Usona Institute.
Yehuda went on to say, “What bothered me when I first heard about [psychedelic] treatment was not only that a psychedelic was being used, which made me gasp a little, but also that there was a claim that one session would make a huge difference.”
A lot of people have stated that they will recover quickly from PTSD. It bothered me a little because PTSD is so difficult to treat, especially in veterans of combat.
Doblin, on the other hand, invited Yehuda to a training in Israel that lasted a week and featured clinicians discussing and viewing footage of MDMA treatments. She went on to say, “The people on the screen really did make me think of veterans at the VA.” They resembled them; They spoke as they did; They had many of the same problems, especially moral harm and a lot of the things that make PTSD so hard to treat. “Why aren’t you doing this at the VA?,” I asked Rick Doblin.
The Department of Veterans Affairs (VA) did not have a procedure in place to carry out such treatments while ensuring the safety of all parties. Yehuda used her expertise and position to create a protocol, which took a lot of work. She is currently conducting a study in which she gives MDMA to sixty veterans over the course of three eight-hour guided therapy sessions with pre- and post-care.
Criticism
Experts Dimitri Mugianis and Ross Ellenhorn, who co-founded the Cardera psychedelic retreat, recently said that traditionally conservative organizations like Thiel and the Mercer Foundation have also invested in psychedelics, which has increased bipartisan support for their research.
Ellenhorn and Mugianis wrote, “Some researchers dream of finding a scientific basis for the hypothesis that psychedelics might help end intractable political conflict,” pondering whether this new coalition is as benign as it appears. Psychedelics certainly have the ability to open people up, but not necessarily to peace and love, eco-fascism, UFO cults, or Nazism.
Experts in bioethics Arthur Caplan and Kenneth Moch have also asked if the Breakthrough Therapies Act can speed up research into breakthrough therapies and if the FDA and DEA should still manage substance schedules together.
“Could the FDA itself take on the oversight work to review how a Schedule I experimental medicine is being used in a clinical experiment and how access is controlled, or does the DEA need to provide a second level of review, as has historically been the norm for Schedule I psychoactive drugs?” The pair inquired. We believe that the first is possible.
Ellenhorn and Mugianis went on to say, “The only long-term solution is to directly address and fix the regulatory complexity that increases cost and delays access to potentially beneficial therapies.”
It is important to note that psychedelics do not directly address the underlying causes of depression, anxiety, or trauma, so they cannot treat these conditions on their own.
The University of California, Berkeley’s Center for the Science of Psychedelics emphasizes that despite the increasing legalization of psychedelics in states, these substances “remain illegal federally, so the impact of new state laws will depend upon the federal government declining to prosecute cases involving these substances.”
For more than a century, Comanche Native Americans and Brazilian religious leaders have waged ongoing battles against the Senate, which remains a stumbling block for cannabis reform and seeks religiously acceptable legal exemptions for the use of psychedelics.
Transparent regulation
Psychedelics may gain regulatory clarity as a result of expanding legislation and the attention of a diverse range of legislators and experts.
Since 2018, psychedelic stocks have experienced some volatility as a result of ballooning attention, funding, and social acceptance. Although the industry as a whole is anticipated to expand at a compound annual growth rate of 11.5 percent between 2021 and 2026, reaching a peak of $6.4 billion by 2028, the hype appeared to reach its peak in January 2021 before falling to unanticipated lows in April 2022.
In this way, the financial story of psychedelics echoes the volatility of cryptocurrency markets in the past, particularly as a result of inconsistent legal controls based on decades-old regulations for their respective industries. Stocks of psychedelics are affected by predictions regarding when the waiting will end. Since the beginning, cryptocurrency has moved.
Still, a lot of people in the cryptocurrency industry say that legislation will help it grow and that 2023 will be the year that lawmakers finally give businesses solid ground rules.
However, overall, psychedelics are more than just a tool for political or financial gain. The circumstances of actual people are influenced by access to their healing power.
Yehuda stated, “A lot of public health issues have become pretty polarized or controversial.” We can all agree that showing respect for veterans’ need to heal after serving our country is important. Because there are so many people who stand to gain from this, that is only the tip of the iceberg. And that is just the beginning. Numerous individuals suffer from mental health issues and trauma.
She said, “We’re having a moment.” We want a path of really careful work to make that moment last. If these treatments are even half as good as we think they are, it will be a big step forward for the healthcare of veterans and our society.”
