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Dept. of Veteran Affairs To Fund Studies on Psilocybin and MDMA for PTSD, Depression

The Department of Veterans Affairs (VA) issued a request for applications (RFA) for proposals from its pool of researchers to study the vast potential of methylenedioxymethamphetamine (MDMA) and psilocybin, the active compound is magic mushrooms, in treating post traumatic stress disorder (PTSD) and depression. The organization is funding this type of research for the first time in decades.

Through this new research initiative, the VA intends to collect definitive scientific evidence on the potential efficacy of MDMA and psilocybin-assisted psychotherapy (or what they call psilocybin-augmented psychotherapy) to treat veterans living with PTSD and depression.

According to The New York Times, the last time that the VA explored psychedelics as a medical treatment was in 1963, when psychedelics were being explored for treating alcoholism and mental disorders. “This is the first time since the 1960s that VA is funding research on such compounds,” the announcement reads. Four government-funded researchers spoke with The New York Times in 2022 about their respective studies involving MDMA and psilocybin as a treatment for military veterans.

Leaders echoed the organization’s support for solid evidence that could help to understand the relationship and eventually back up medical claims related to psychedelic-assisted therapy. “Our nation’s Veterans deserve the very best care, and VA is constantly supporting innovations to deliver that,” said Secretary of Veterans Affairs Denis McDonough. “This is an important step to explore the efficacy of a potential new set of promising treatments that could improve the health and quality of life for veterans.”

PTSD represents a $230 billion estimated annual economic burden in the U.S., lending to the idea that alternative treatments are desperately needed.

“Veterans and VA researchers have told us about the potential promise of psychedelics to treat mental health conditions for some time,” VA’s Under Secretary for Health Dr. Shereef Elnahal said in a statement. “Now is our chance to study this potential method of treating Veterans with PTSD and major depression across the country.” A spokesperson said that the VA had nothing additional to share to High Times.

MDMA and psilocybin are controlled substances, but research on them can be conducted via rigorous regulatory approvals, including approvals from the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA).

The FDA granted breakthrough therapy status for MDMA for treating PTSD and psilocybin for treating depression in 2018 and 2019, respectively. The announcement notes that last September, a chorus of VA and other federal clinicians, scientists, and policymakers gathered in Denver, Colorado to assess the state of existing scientific evidence regarding psychedelic-assisted therapies. That helped to provide advice to VA leadership, recommending that their team begin funding their own studies into these compounds. This guidance was based on previously published studies that show promise, yet they did not include veterans.

Researchers at Johns Hopkins learned that psilocybin-assisted therapy, along with supportive therapy, can reduce symptoms of depression for up to 12 months. In addition, 86% of participants in a recent peer-reviewed study achieved a “clinically meaningful benefit” from using MDMA to treat PTSD.

VA organizations including the American Legion, Disabled American Veterans, and mental health provider groups called for expanding research.

The National Defense Authorization Act (NDAA) for fiscal year 2024, or H.R. 2740, authorized the study of psychedelics within military populations by the Department of Defense. With this new announcement, VA will join the National Institutes of Health in supporting research that will yield insights for treating PTSD and depression.

The new RFA will allow for the critical step of directly assessing the efficacy and safety surrounding MDMA and psilocybin-assisted psychotherapy–but this time, with Veterans.

Keeping on the safe side, the VA added the disclaimer, “VA does not recommend psychedelics for use as part of a self-treatment program.”

https://hightimes.com/news/dept-of-veteran-affairs-to-fund-studies-on-psilocybin-and-mdma-for-ptsd-depression/

EXCLUSIVE: Veterans Affairs Found Safety Signal for Pfizer COVID Vaccine, Never Disclosed It

A federal agency detected early in the COVID-19 vaccination campaign a safety signal for a serious problem for Pfizer’s shot, a document obtained by The Epoch Times shows.

The U.S. Department of Veterans Affairs (VA) detected a signal for myocarditis and pericarditis for the Pfizer-BioNTech vaccine, according to the document, an email from May 13, 2021.

Myocarditis is heart inflammation while pericarditis is inflammation of tissue around the heart.

Data from the VA Center For Medication Safety showed “a signal for myocarditis/pericarditis … with Pfizer vaccine following the 1st dose,” Fran Cunningham, a VA official, wrote in the email.

She was communicating with Dr. Tom Shimabukuro and Dr. Lauri Markowitz, two top vaccine safety employees with the U.S. Centers for Disease Control and Prevention (CDC).

Ms. Cunningham and the VA did not respond to requests for comment.

The discovery of the signal was never shared with the public by the VA or the CDC.

Inquiries sent to Drs. Shimabukuro and Markowitz were funneled to a CDC spokesperson, who said that the VA later determined the signal “was not a true signal.”

VA officials, according to a presentation obtained by The Epoch Times, told a private meeting that included CDC officials in June 2021 that no signal had been found in a surveillance system. No audio or transcript of the meeting has been made public.

The CDC also failed for months to convey a separate signal detected in its Vaccine Adverse Event Reporting System, according to previous reporting by The Epoch Times.

“This is yet another agency that warned the CDC regarding the myocarditis signal and affirmed that it was a ’real' signal using epidemiologic data,” Brian Hooker, chief scientific officer with the nonprofit Children’s Health Defense, told The Epoch Times via email.

“The CDC and VA had a strong responsibility to let the public know about the signal but chose to bury it in order to avoid causing ‘vaccine hesitancy’ by showing the actual risks of the COVID-19 vaccine,” he added.

The CDC throughout the COVID-19 pandemic has aggressively promoted COVID-19 vaccination. The VA was the first federal agency to require workers to receive the COVID-19 shots, and kept its vaccine mandate in place after many other agencies rescinded theirs.

The Epoch Times obtained the email through the Freedom of Information Act.

A safety signal is a sign a vaccine might cause a health problem.

The CDC and other agencies have since acknowledged that all four COVID-19 vaccines that have been or are available in the United States can cause myocarditis and pericarditis, particularly in young males. The Pfizer and Moderna shots, which both utilize modified messenger RNA (mRNA) technology, were the first to be linked to the inflammation.

The U.S. military, which is comprised of mostly young men, was among the first entities to start recording cases of the post-vaccination inflammation. The CDC started receiving reports shortly after the vaccines were rolled out in December 2020.

Dr. Shimabukuro, in an email to CDC colleagues after receiving word from the VA, said that there was an “increasing urgency” to deal with the post-vaccination myocarditis. He suggested having VA officials join a private call to “exchange information” and discuss the matter.

Two additional emails, sent by CDC officials, were fully redacted.

Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, said the new emails show “both the VA and CDC knew there was an alarming signal for heart inflammation.”

“Yet the public was not informed that this signal had been detected, an early warning sign that turned out to be a very real causal association between myocarditis/pericarditis and mRNA COVID shots,” Ms. Fisher told The Epoch Times via email.

Mr. Hooker, who has been researching vaccine safety for years, found by analyzing reported cases that a signal for myocarditis emerged from CDC data in February 2021. Emails obtained by The Epoch Times showed Israel warned the CDC of cases by the end of that month. But the agency did not raise the alarm publicly until May 2021—by which time millions of Americans had received COVID-19 vaccine doses—did not say there was a likely association until later in 2021, and did not definitively say the vaccines caused the condition until 2022.

https://www.theepochtimes.com/health/exclusive-veterans-affairs-found-safety-signal-for-pfizer-covid-vaccine-never-disclosed-it-5561709