There are concerns over the research on MDMA therapy
The FDA Study of MDMA in Post-traumatic Stress Disorder and Implications for Border City Actions of the U.S. President Biden
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A panel of FDA experts are starting to review the trial data in order to determine if the drug MDMA, commonly known as ecstasy, is appropriate for use in post-traumatic stress disorder. Some trial participants described the treatment as transformational. The validity of the study’s results was found to be questionable by the Institute for Clinical and Economic Review.
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. The mayors of border cities have been invited to join him at the White House.
Medical professionals in Georgia: Cost, access, and Medicaid expansion: The impact of election results on Medicare and Medicaid for patients living in a rural area
The ballot count is underway after six weeks of voting among India’s nearly one billion eligible voters. Initial results show that Prime Minister Modi will win a third term. If confirmed, he will be the first PM after Jawaharlal Nehru to win more than one term.
For many people, it means worrying whether they can afford the care they need. I recently traveled to Georgia to hear about three key issues: cost, access and Medicaid expansion.
There is no other local option for basic care in the small town of Elberton, which is about two hours east of Atlanta. Patients with needs beyond what the clinic can provide have to travel at least 45 minutes away to find care.
Georgia did not expand Medicaid. The income of Amy Wilson, who had a brain tumor and cancer, is $30 over the threshold to qualify for Medicaid, making it difficult for her to afford the care she needs. I watched the Atlanta Philharmonic Orchestra’s artistic director strap her baton to her palm before a rehearsal so that she wouldn’t hold it for long periods of time.
The upcoming presidential election will likely involve two people: Joe Biden and Donald Trump. They have very different visions of what health care should look like. People I spoke with are concerned about how election results will change the care they already have. Almost every doctor and patient I spoke with said they would have all that in mind when they cast their ballot in November.
Source: FDA reviews MDMA for PTSD treatment; Biden to issue executive order on border policy
The FDA’s first study of MDMA for PTSD is critical: Lack of evidence for psychological intervention and lack of blinding in clinical trials
Plants can absorb red and blue light and reflect green light back into our eyes. They also reflect other wavelengths, like near-infrared light. Although humans can’t see it, artist Scott Kildall uses an infrared sensor to translate near-infrared light into sound. He uses his device to turn California’s Joshua trees into an instrument.
It represents a major setback for proponents of the drug and Lykos Therapeutics, which sponsored clinical trials of the drug. It could endanger the FDA’s approval of the therapy, which would allow it into mainstream mental health care.
The FDA staff and members of the advisory panel spoke about weaknesses in the clinical research that could jeopardize its approval.
Agency staff focused on uncertainties and gaps in the data, unanswered questions about its potential for abuse and a lack of evidence supporting the psychological approach used in the 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.
Some of the claims that surfaced in a petition to the agency and outside reports on the trials were acknowledged by scientists with the FDA.
There are only two FDA-approved treatments for the condition and MDMA would be the first to come on the market in decades. It would also be a milestone for the broader effort to expand access to psychedelics.
“In totality, these results support [that] MDMA in combination with psychological intervention provides significant and meaningful reductions in PTSD symptoms and functional impairment in patients with PTSD,” said Berra Yazar-Klosinski, chief scientific officer for Lykos.
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.
“We noticed a striking lack of abuse-related adverse events,” said Millis, noting that the FDA had advised the study sponsors to collect this type of data.
Source: FDA advisors reject MDMA therapy for PTSD, amid concerns over research
MDMA therapy for PTSD, amid concerns over research: Follow-up observations suggest that the prevalence of suicidal thoughts is the same between MDMA and Schedule II drugs
According to the review by the agency, MDMA has the same abuse potential as aSchedule II drug, which includes cocaine.
If they go on to abuse MDMA, Maryann Amirshahi, a professor of emergency medicine at Georgetown University, says she is less concerned about the safety in the acute setting.
Data from a follow up observational study was presented to back up the positive findings on 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 prevalence of suicidal thoughts was the same between the two groups in the study, despite the fact that most of those in the study had a history of suicidal thoughts.
That point is particularly contentious because of recent allegations that certain adverse events were not reported. A former employee of the drug company is cited in the FDA petition calling for an advisory meeting.
Let’s try not to pay too much attention to this. It was sexual misconduct. 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 the ‘Survival of Suicidality’ by Lilienstein: “A Critical Analysis of the FDA Study of a Patient’s Psychopathology and Related Complaints”
The public comment submitted to the FDA by a participant stated that her therapist told her to see worsening symptoms as a sign of healing and spiritual awakening and that she and other participants later struggled with suicidality.
According to reports in the ICER report, some people may have been discouraged from taking part in the long term study.
Lilienstein said all participants were given the chance to review their consent, but some chose not to, but otherwise everyone was given the opportunity.
