Psilocybin, the psychoactive compound in magic mushrooms, is proving a prodigious treatment for anxiety, depression, addiction, and one study even found it may lead to neurogenesis, or the regrowth of brain cells. So when will doctors finally be able to write prescriptions for psilocybin? In this opinion piece, Dr. David E. Nichols, psychedelic research expert and co-founder of The Heffter Research Institute, explains what steps it will take to get medicinal psilocybin legalized.
Many people have now seen media stories about the renewed research interest in psychedelics as medicines, often called a “renaissance” in psychedelic research, over perhaps the past five years or so. Although many psychedelic substances have been used safely as medicines in indigenous cultures for millennia, we are now seeing renewed interest in these substances in Western cultures. As a co-founder of the Heffter Research Institute I have watched with an increasing sense of both amazement and gratitude — that we have been able to accomplish so much in such a relatively short time. We are on the path to make psilocybin into a prescription medicine! The Heffter Institute has been a key driver of this “renaissance,” utilizing most of the donations we receive directly to support clinical research.
Heffter initially provided major funding for a small study of psilocybin treatment for obsessive-compulsive disorder (OCD) patients, at the University of Arizona. That study provided mixed but encouraging results that have yet to be pursued due to funding limitations.
Our first truly successful study was treatment of 12 terminal cancer patients who suffered from anxiety and depression. They were treated with a program of therapy that included psilocybin, the active component in so-called magic mushrooms. Participants showed a significant reduction in anxiety at one and three months after treatment, with no significant adverse events. That study, led by Dr. Charles Grob at the UCLA Harbor Medical Center, was published in 2011 in Archives of General Psychiatry, widely recognized as perhaps the top psychiatry journal in the world.
Subsequently, two additional studies were begun using psilocybin to treat anxiety and depression in cancer patients, one at Johns Hopkins University led by Dr. Roland Griffiths, and the other at New York University (NYU) directed by Dr. Stephen Ross. The patients in both studies have almost completed their treatments, then the studies will start the follow-up and data analysis stage. Preliminary analysis points again to significantly decreased anxiety and depression.
In addition, the Heffter Institute recently sponsored a study of psilocybin-assisted therapy in a pilot study of 10 volunteers with alcohol dependence. The principal investigator for this study was Dr. Michael Bogenschutz, at the University of New Mexico (UNM). Drinking decreased significantly beginning in the second month of treatment, after psilocybin was administered, and improvement remained significant for an additional six months of follow-up. There were strong correlations between the intensity of the experience in the first psilocybin session and clinical improvement following the session. Based on the positive findings from this pilot study, we are now implementing a larger randomized trial at UNM and NYU.
We also recently supported a pilot study by Dr. Matthew Johnson at Johns Hopkins, administering psilocybin within a 15-week smoking cessation treatment. Participants were 15 healthy smokers with a mean of six previous lifetime quit attempts who were smoking an average of 19 cigarettes per day for 31 years. Measures of smoking behavior showed that 12 of the 15 participants (80%) were no longer smoking at six-month follow-up. This smoking cessation rate substantially exceeds rates commonly reported for other types of therapies (typically less than 35%). These findings suggest that psilocybin may be a useful and potentially efficacious adjunct to current smoking cessation treatment approaches, and warrant a follow-up clinical trial. Results also illustrate a framework for research on the efficacy and mechanisms of psychedelic-facilitated addiction treatment.
When people hear that we are sponsoring medical research with psilocybin, they often ask, “How long before doctors will be able to prescribe it?” The process to get there is both expensive and time-consuming. To get a drug to market, that is, to make it into a medicine, there are three clinical phases that must be completed. Phase 1 involves giving a new drug to humans to determine whether it can be tolerated, if it is safe, and what doses are acceptable. For psilocybin, there are extensive data with respect to doses and safety of psilocybin, particularly as it has been used in the form of psychedelic mushrooms since prehistoric times. Further, none of the participants in our treatment studies has required medical or psychiatric intervention.
After passing Phase 1, the drug is then moved to Phase 2, where it is administered to patients suffering from the medical condition one wishes to treat. In our case, it is cancer patients who have severe anxiety and depression as a result of their cancer diagnosis, including those who are near the end of life. Although Phase 1 can be relatively small, Phase 2 studies must be large enough to demonstrate a statistically significant improvement in the condition being treated; in this case it is anxiety and depression.
Once Phase 2 studies have demonstrated that the medicine reduces the patients’ symptoms, called efficacy, a Phase 3 trial must be completed. Phase 3 studies are much larger, but use the same medication and essentially the same treatment paradigm that was used in Phase 2. Also, Phase 3 studies are typically conducted at several different clinical sites to show that the improvement observed in the Phase 2 studies can be repeated by other clinical scientists. When the Phase 3 studies are completed, if significant safety and efficacy can be shown, the FDA can then approve the medicine as safe and effective for the indicated condition.
One important implication of such a finding by the FDA concerns drugs that are controlled substances. Psilocybin is a controlled substance and is placed in the most restrictive category of drugs, Schedule I. Schedule I drugs can only be used in research; they cannot be prescribed as medicines. Drugs are placed into Schedule I if they meet three criteria, if they have: 1) A high potential for abuse; 2) No recognized medical use and; 3) No safety when used under medical supervision. All three of these criteria must be met when placing a drug into Schedule I.
To make psilocybin into a prescription drug, these factors must be addressed. First, the safety of psilocybin is being established not only by our studies, but also by studies in Switzerland and the U.K. The key point that needs to be addressed, however, is the issue of psilocybin having a recognized medical use. If our Phase 3 studies show efficacy in alleviating anxiety and depression in cancer patients, and the FDA recognizes that finding, we will have established a medical use for psilocybin. It then can no longer remain in Schedule I and will have to be placed into a lower schedule such as Schedule II or Schedule III. Although substances in Schedules II and III are still controlled, this rescheduling will allow psilocybin to be used by qualified physicians as a medical treatment for anxiety and depression.
How long will it be before psilocybin can reach the status of being a recognized medical treatment? Assuming that we can demonstrate efficacy in the Phase 3 studies, as it appears we have in the current Phase 2 studies, the timing largely depends on how quickly we can complete the Phase 3 studies. Our most efficient recruiting so far has been at NYU, where the study team has recently averaged 15 patients per year. We would plan to recruit patients across several clinical sites – optimistically up to five, and would expect that with average to good recruitment rates we might complete recruitment, study procedures, and data analysis in four to five years.
How much will the Phase 3 studies cost? As a not-for-profit institute, our costs have been lower than they might be if we were a for-profit pharmaceutical company. Even so, as an average, treatment is costing us approximately $25,000 per patient. That includes costs for clinical treatment rooms, medication, therapists, and many other ancillary costs required to carry out a clinical study. It would be reasonable to expect total costs for a Phase 3 trial of this nature to be on the order of $7.5-8 million.
Many people also ask, “Aren’t drug companies interested in psychedelic medicine?” The answer, unfortunately, is no. Psychedelic medicines have been around so long that they are no
longer patentable, and they work after one or sometimes two treatments. There is no money to be made with a non-patentable drug that is given only once or twice in a lifetime. Typical drug treatments are given daily, sometimes two or more times a day, and for many medical conditions the treatment can last years, or even a lifetime.
The next question they often ask is, “Isn’t there any government funding for this work?” Again, sadly, the answer has been no, although we hope that may change as our studies progress. We must still overcome the echoes of the past, where psychedelics were considered dangerous and unpredictable. Fortunately, more enlightened voices are beginning to prevail and the landscape is slowly changing. If you would like to become a part of this powerful and emerging medical science, go to our web site www.heffter.org and make a donation to support our work.
This article originally appeared on reset.me, and is reposted here with permission as a contribution from Emmy Award winning investigative journalist Amber Lyon.
Credits: Article Written By David E. Nichols, PhD. Used here with permission.
SpaceX Will Help Launch A Remote-Controlled Car Race On The Moon
SpaceX with its Falcon 9 rocket will be involved in sending 5.5 pounds of remotely-controlled race cars to the lunar surface, aiding the first-ever remote car race on the Moon!
If all goes according to plan, the Falcon 9 rocket will deliver the remote-controlled vehicles to the moon’s surface by October 2021, New Atlas reported.
The interstellar race is being organized by a company called Moon Mark, a multimedia and education content business, which partnered with Intuitive Machines, a Houston-based aerospace company.
Intuitive Machines believes it could soon become “the first private aerospace company to land on the Moon,” according to a recent press release. But SpaceX, a company headed by Elon Musk, one of the world’s most bizarre CEO’s, won’t just allow that to happen without his company’s own involvement.
The SpaceX’s Falcon 9 rocket will assist Intuitive Machines in getting its Nova-C lander onto the moon to deploy the race cars.
The cars will race around the sandy dunes of Oceanus Procellarum, a plain near the western edge of the Moon.
The track will be designed by Formula One racecar track designer Herman Tilke. While McLaren P1 designer Frank Stephenson is involved in designing the cars, along with High School kids.
The “deployment mechanism” used to deposit the 5.5 lb cars on the lunar surface will weigh a further 6.6 lbs. That’s a total of 17.6 lb combined weight being sent into space to our moon.
“Moon Mark’s Mission 1 competition will include six diverse teams of high school students selected from across the United States,” reads a press release, “who will compete in a series of qualifying challenges that include unique demands, such as drone and autonomous vehicle racing, e-gaming, and a space commercialization entrepreneurship contest. The two top teams from the qualifying rounds will win a once-in-a-lifetime opportunity to build and race two vehicles on the Moon. The vehicles will be loaded onto Intuitive Machines’ Nova-C Lunar Lander, launched from Earth on SpaceX’s Falcon 9 rocket, and land in 2021. Competitors will then race their rovers remotely, navigating through harsh terrain, racing around a sphere of cameras, which will capture every aspect.”
Lets hope that 2021 is a better year than 2020 was, with space racecars we definitely have something to look forward to.
Congress to Vote This Week on Bill to Legalize Cannabis, End Federal Prohibition
After months of debate and partisan stalling, the Marijuana Opportunity Reinvestment and Expungement (MORE) Act of 2019 is set for a vote before a full chamber of Congress by the end of this week.
The bipartisan bill sponsored by Vice President-elect Kamala Harris has been touted as the most comprehensive federal cannabis reform legislation ever introduced and comes after over half a century of a failed “war on drugs” that fueled mass incarceration and other collateral damage for poor communities.
Late last week, Majority Leader Steny Hoyer advised the Congress that the MORE Act would be taken up by the House at some point between Wednesday evening and Friday.
In a September statement, Hoyer said that “The MORE Act remains a critical component of House Democrats’ plan for addressing systemic racism and advancing criminal justice reform.”
The bill has also gained the support of both liberals and libertarian-leaning conservatives who see the responsible use of cannabis as a personal right, as well as other Republicans who believe that it should be up to the states to regulate the dispensation of the plant without the interference or control of federal authorities.
The MORE Act comprehensively decriminalizes cannabis on a federal level by de-scheduling it from the Controlled Substances Act – where it is absurdly classified as a Schedule 1 drug “with no currently accepted medical use and a high potential for abuse” alongside heroin – and opens the door to states setting their own policies regulating the commerce and consumption of the plant.
A major highlight of the bill includes expungements of federal convictions for a number of federal convictions of low-level cannabis offenders, removing a barrier that bars access to voting, employment, professional licenses, housing, and even the ability to adopt a child. States would be incentivized to also follow suit.
The legislation would also provide for re-sentencing and block federal agencies from denying public benefits and security clearances over past cannabis convictions, while immigrants would no longer be denied citizenship over marijuana.
The MORE Act would also levy a 5% sales tax on commercial cannabis, and investing in grant programs addressing the needs of communities who have suffered serious negative impacts from the “War on Drugs,” especially those communities of color that have suffered disproportionate over-policing and mass incarceration.
Other provisions of the MORE Act include providing opportunities for cannabis businesses and expanding medical cannabis programs within the U.S. Department of Veterans Affairs.
Cannabis has already been comprehensively legalized for recreational use in 15 states, and another 21 states have legalized medical use of marijuana through physician prescriptions.
A vote on the MORE Act had initially been set for September, but the vote was delayed as Congress wrangled over the passage of a coronavirus aid bill before moving on to addressing legalization.
The passage of the MORE Act could also be a boon for cash-strapped budgets across the country, which have seen tax revenue dry up amid the economic devastation wrought by the ongoing pandemic. The creation of a state-regulated cannabis market across the country is expected to create an up to $37 billion business within five years.
“Times have changed — marijuana should not be a crime,” Vice President-elect Harris said in a 2019 press release. “We need to start regulating marijuana, and expunge marijuana convictions from the records of millions of Americans so they can get on with their lives. As marijuana becomes legal across the country, we must make sure everyone — especially communities of color that have been disproportionately impacted by the War on Drugs — has a real opportunity to participate in this growing industry.”
However, while the House has offered clear bipartisan backing of the bill, GOP senators have been far less favorable toward the bill. Senate Majority Leader Mitch McConnell has blasted the bill on Twitter, remarking earlier this year on a study about diversity within the cannabis industry: “This is their effort at coronavirus relief?”
In 2018, a study from Pew Research Center found that cannabis-related offenses comprised 40% of all 1.65 million total drug arrests in the U.S. that year.
However, another study by Pew in late 2019 found that two-thirds of respondents across the country support the legalization of both medical and recreational marijuana.
White House is Being Investigated by DOJ for Alleged Presidential Pardon Bribery Scheme
In a potentially explosive development in the waning days of outgoing President Donald Trump’s administration, the Justice Department is investigating an alleged “bribery-for-pardon” scheme involving cash payments to the White House or its associates in exchange for a presidential pardon.
The heavily-redacted court records unsealed Tuesday in federal court do not name any individuals involved nor do they mention President Trump, or whether any officials in the White House were acquainted with the scheme.
However, the legal drama that the records hint at create new, dark clouds over the outgoing administration after a number of his top associates and advisers have faced federal criminal charges while Trump has openly mulled pardoning those who have proven their loyalty to him.
In 20 pages of partially redacted documents unsealed by the DC District Court, the question is discussed of whether prosecutors can review documents that are potentially protected by attorney-client privilege and were seized after a search warrant.
The records also reveal Chief Judge Beryl A. Howell’s Aug. 28 opinion on an ongoing investigation involving at least two figures who “acted as lobbyists to senior White House officials, without complying with the registration requirement of the Lobbying Disclosure Act… to secure ‘a pardon or reprieve of sentence for” an individual whose name is redacted.
In the review, the judge noted that the communications could be reviewed by investigators because the email discussion involved a non-attorney.
“This political strategy to obtain a presidential pardon was ‘parallel’ to and distinct from one individual’s role as an attorney advocate for” another individual, the ruling added, with both names involved being redacted.
According to the filings, the communications were seized from an office in a raid that occurred at some point prior to the end of summer 2020.
During the raid, a filter team – meant to ensure that prosecutors don’t receive tainted evidence that should not have fallen into their hands because it was privileged – had over 50 digital devices, including smartphones, tablet computers, laptops, thumb drives and hard drives after investigators raided the undisclosed offices, reports CNN.
In the court documents, prosecutors requested access to the filter team’s trove of devices. This is because the prosecutors believed that the holdings showed alleged crimes such as a “secret lobbying scheme” and bribery conspiracy that solicited “a substantial political contribution in exchange for a presidential pardon or reprieve of sentence” for a defendant who was convicted, according to the redacted records.
“The political strategy to obtain a presidential pardon was ‘parallel’ to and distinct from [redacted]’s role as an attorney-advocate for [redacted name],” Judge Howell wrote in the court order.
A grand jury investigation was also revealed, and appears to relate to unnamed parties who acted as unregistered “lobbyists to senior White House officials” and pursued pardons while using an intermediary to transmit bribes, the records say.
However, prosecutors have not provided evidence to the judge of any direct payment. Instead, they showed evidence that the redacted person was seeking clemency in return for past and future contributions to a political campaign.
Over the last week, the Department of Justice has informed Judge Howell that it wants the filings to reman confidential in court because “individuals and conduct” have not been publicly charged with any crimes related to the potential scheme.
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