First Day of Elections: A Brief Report on Prime Minister Narendra Modi’s Presidency at the White House and the Status of Border Cities

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A report from the Institute for Clinical and Economic Review concluded there was insufficient evidence to assess the overall benefit of MDMA-assisted therapy.

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. He’s invited several mayors of border cities 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. If he’s confirmed, he will be the first prime minister since Jawaharlal Nehru to win three terms.

Cost, Access, and Medicaid: What Should Patients Care For? A Conversation with Amy Wilson in Elberton, Georgia during the November Presidential Election

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.

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’s income is over the cutoff to be eligible for Medicaid, which makes it very difficult for her to afford the care she needs. The artistic director of the Atlanta Philharmonic Orchestra is no longer able to hold her baton for long periods of time, so she put it on the palm of her hand.

Donald Trump and Joe Biden will likely be involved in the presidential election. They have very different visions of what health care should look like. The added layer of worry for people I spoke with is 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

Interpretation of the infrared light and sound of an artist’s instrument to make a musical instrument out of Joshua trees: An open problem for the FDA

Plants are green because they absorb red and blue light and reflect green light back to our eyes. The light reflected by them is also near-IR 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 make a musical instrument out of Joshua trees.

It is a major disappointment for proponents of the drug, as they had sponsored the trials. It could affect the FDA approval of the treatment, which would bring it into mainstream mental health care.

The FDA and advisory panel highlighted flaws in the clinical research that could affect the approval of the drug.

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.

There are allegations that there could have been bias in the trials and that could have skewed the results.

The FDA acknowledged they were looking at 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 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.

Berra Yazar-Klosinski, the chief scientific officer for Lykos, said that these results show that the combination of MDMA with psychological intervention has a significant reduction in 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.” The data helps inform the FDA’s assessment of the drug’s abuse potential.

“We noticed a striking lack of abuse-related adverse events, which was a result of the FDA’s advise to the study sponsors to collect this kind of data,” said Millis.

Source: FDA advisors reject MDMA therapy for PTSD, amid concerns over research

MDMA therapy for PTSD, amid concerns over research, has not been prescribed by the FDA for chronic abuse, according to a study by Lykos

While MDMA is currently listed as a Schedule III drug, the agency’s review found it has the same abuse potential as a Schedule II stimulant, a category that includes cocaine.

“We’re actually managing more and more severe cases of MDMA overdose, and so I’m less concerned about the safety in the acute setting, but more chronically if they go on to abuse MDMA,” said Maryann Amirshahi, a professor of emergency medicine at Georgetown University and a member of the committee.

Alongside its positive findings on the short-term effects of MDMA, Lykos presented data from a follow-up observational study intended to suss out the staying power of the treatment.

According to Yazar-Klosinski, data that has not been published in a journal, seems to suggest evidence of MDMA’s resilience to at least six months.

The majority of those in the study had a history of suicidal ideation in their lifetime, but during the study period “the frequency of these symptoms was comparable between the two groups, said Dr. Alia Lilienstein, senior medical director for Lykos Therapeutics.

The point is controversial because of allegations that adverse events weren’t reported. A former employee of the drug company was cited in a petition that was filed with the FDA.

“Let’s try to not gloss over this misconduct. It was not a normal thing. 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

Comment on a Patient’s Suicidality Inferred from Observations by a Physician in the Long Term Duration of the Clinical Trial, as Perturbed by the FDA

A woman who was in the trial submitted a public comment to the FDA that her therapist encouraged her to view symptoms as evidence of healing, and that she and other participants struggled with suicidality after the trial.

According to the report, there may have been discouraged from taking part in the long term durability study.

“Those were investigated as well,” said Lilienstein with Lykos, “All participants who were interested in participating were given the opportunity to review consent, and some chose not to participate after reviewing consent, but otherwise everyone was given the opportunity.”