AMAZON: An Advisory Panel on the Use of the Psychedelic MDMA for Post-traumatic Stress Disorder and Implications for Prime Minister Narendra Modi
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A panel of experts advising the Food and Drug Administration on the use of the psychedelic MDMA for post-traumatic stress disorder found on Tuesday that the available evidence doesn’t show that the drug is effective or that its benefits outweigh its risks.
President Biden is expected to issue an executive order outlining actions his administration will take to address the high number of asylum seekers at the southern U.S. border. Several border cities have been invited to join him at the White House.
The ballot count is underway after six weeks of voting among India’s nearly one billion eligible voters. Initial results suggest that Prime Minister Narendra Modi of the BJP party will win a third term. He would be the only prime minister after Jawaharlal Nehru who had not won a third term.
Healthcare Cost, Access, and Medicaid Expansion in Elberton, Georgia: Joe Biden and Donald Trump Will Vote in November
It means a lot for people to be worried if they can afford the care that they need. I recently traveled to Georgia to hear about three key issues: cost, access and Medicaid expansion.
In Elberton, a town of just under 5,000 residents a couple of hours east of Atlanta, a rural health clinic is one of the only local options for basic care. But when a patient has needs beyond what the clinic can provide, they usually have to travel at least 45 minutes away to find care.
Georgia has not expanded Medicaid. Amy Wilson, who had a brain tumor and cancer, cannot afford the care she requires because her income is over threshold to qualify for Medicaid. I watched the conductor of the Atlanta Philharmonic Orchestra strap her baton to the palm of her hand because she could no longer hold it for a long period of time.
Joe Biden and Donald Trump will both be running for president. They have very different visions of what health care should look like. People are worried about how the election results will affect their care. I spoke with many doctors and patients who said they would cast their ballot for the election in November.
Source: FDA reviews MDMA for PTSD treatment; Biden to issue executive order on border policy
A meeting of FDA advisors rejecting MDMA therapy for PTSD, amid concerns over research: Scott Kildall, MDMA, and Berra Yazar-Klosinski
Plants are green because they absorb red and blue light and reflect green light back to our eyes. They reflect some light, as well as other light. Scott Kildall uses a sensor to translate light into sound that can’t be seen by humans. He uses his device to turn the Joshua trees into instruments.
It is a major blow to the proponents of the drug, and to the company that sponsored the trials. FDA approval of the treatment could be jeopardized by this.
Remarks during the meeting from FDA staff and members of the advisory panel highlighted some major stumbling blocks — shortcomings in the clinical research that could jeopardize its shot at being approved.
There are uncertainties and gaps in the data, there are unanswered questions about its potential for abuse, and a lack of evidence supporting the psychological approach used in therapy sessions.
Some on the panel have explicitly brought up allegations that have surfaced about possible misconduct and bias in the trials that could have skewed the results.
Scientists with the FDA didn’t share details, but acknowledged the agency was investigating some of the claims, which have surfaced in a petition to the agency and outside reports on the trials.
There are only two FDA-approved treatments for the condition and MDMA is the first one to come on the market in decades. It would be a victory for the effort to improve access to drugs.
According to Berra Yazar-Klosinski, chief scientific officer for Lykos, MDMA in combination with psychological intervention reduces symptoms of Post Traumatic Stress Disorder.
While the study took steps to “blind” study participants, there was considerable discussion around the fact many of those in the study could tell they had received the experimental drug, leading to what’s known as “functional unblinding,” which can ultimately affect the results.
Another potential sticking point could be the lack of data about how patients experienced the acute effects of the drug, including feelings like “euphoria” or “elevated mood.” That data helps inform the FDA’s assessments of the drug’s abuse potential.
The sponsors of the study were advised by the FDA to collect this type of data.
Source: FDA advisors reject MDMA therapy for PTSD, amid concerns over research
MDMA and sexual conduct: FDA advises that MDMA therapy for PTSD is not prescribed for treatment of PTSD, amid concerns over research
The agency reviewed MDMA and found that it was as addictive as a Schedule II drug and had the same abuse potential.
Maryann’s concern about the safety of the acute setting is not as important as it is about the severity of MDMA overdoses, and so she is less concerned about that than she is about the likelihood of abuse of the drug.
Data from a follow-up study was presented along with findings on the short-term effects of MDMA.
While not yet published in a peer-reviewed journal, that data “suggest evidence of MDMA’s durability to at least six months,” said Yazar-Klosinski with Lykos.
The majority of those in the study had a history of suicidal thoughts, but the symptoms of suicidal thoughts were the same as those in the other group.
That point is particularly contentious because of recent allegations that certain adverse events were not reported. The FDA received a petition for an advisory meeting that outlined concerns from a former employee of the company.
We need to don’t get carried away with this malfeasance. It was sexual conduct. That’s particularly important,” said Elizabeth Joniak-Grant, a sociologist and a member of the panel.
Source: FDA advisors reject MDMA therapy for PTSD, amid concerns over research
Comments on a Study of Suicide and Healing in the Afterglow of Suicidality: A Panel Discussion with Dr. B. Walter
One trial participant submitted a public comment to the FDA, stating that her therapist encouraged her to view worsening symptoms as evidence of healing and spiritual awakening, and that she and other participants later struggled with suicidality following the trial.
Dr. Walter was a panelist and asked about the idea that some people might have been discouraged from participating in the long term study.
Everyone received the chance to review consent and if they did not, no one would participate, but for others it could have been different.