FDA reviews MDMA for treatment of post traumatic stress disorder; Biden will issue an executive order on border policy
Prime Minister Narendra Modi in the White House: On the Status of the Up First Program and the High Number of Asylum Seekers at the Border
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The panel of experts that advise the Food and Drug Administration on the use of MDMA did not find the evidence to show that the drug is effective or that its benefits outweigh its risks.
The administration of Biden is expected to issue an executive order detailing actions to address the high number of asylum seekers at the southern U.S. border. mayors from 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 show that Narendra Modi will win a third term as the Prime Minister. If he’s confirmed, he would be the only prime minister after the founder of modern India, Jawaharlal Nehru, to win three terms.
Healthcare Choices in Atlanta: The Case of Amy Wilson, a Baton Artist, and a Patient with Neuroblastic Brain Tumors
For many people, it means worrying whether they can afford the care they need. Medicaid expansion, cost and access are some of the issues I heard about in Georgia.
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. So Amy Wilson, who had a brain tumor and cancer, is struggling to afford the care she needs because her income is $30 over the threshold to qualify for Medicaid. The artistic director of the Atlanta Philharmonic Orchestra couldn’t hold her baton for long periods of time so she moved it to her hand before the rehearsal.
The upcoming presidential election will likely include two people, Joe Biden and Donald Trump. They have very different visions of what health care should look like. The concern that people have is how election results will change their care. Most of the doctors and patients I spoke with said they would cast their ballot in November because of all that.
Source: FDA reviews MDMA for PTSD treatment; Biden to issue executive order on border policy
Clinical reviewer and expert panelist voiced challenges to the approval of a psychedelic opioid dose-drug for neurodegenerative dementia
Plants are green because they absorb red and blue light and reflect green light back to our eyes. They also reflect other wavelengths, like near-infrared light. Scott Kildall uses aninfrared sensor to translate light into sound, which is not visible to humans. He made a device that turned the California’s Joshua trees into instruments.
It represents a major setback for proponents of the drug and Lykos Therapeutics, which sponsored clinical trials of the drug. It could jeopardize FDA approval of the treatment, which would make it 888-282-0465 888-282-0465 888-282-0465 888-282-0465 888-282-0465 888-282-0465.
During the meeting with FDA staff and members of the advisory panel, there were some significant stumbling blocks that could jeopardize its approval.
Agency staff focused on uncertainties and gaps in the data, unanswered questions about the potential for abuse, and a lack of evidence to support 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.
“Although we do have two positive studies, the results are in the context of dramatic functional unblinding,” says Dr. David Millis, clinical reviewer for the FDA.
MDMA would be the first FDA-approved treatment for the condition in decades. It is a significant milestone for the effort to expand access to psychedelics.
According to one study, about 32% of the placebo group that received therapy sessions but did not get an active drug, no longer met diagnostic criteria for PTSD after three MDMA treatments, compared to 67% of the participants in the MDMA treatment arm.
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.
The lack of data on how patients experienced the acute effects of the drug could be a sticking point. The data is used by the FDA to assess 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
Review and Discussion of MDMA Suicidal Ideation: Do People Really Need to Use Schedule II Drugs, if Not Drugs?
According to the review by the agency, MDMA has the same abuse potential as a Schedule II drug, which 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.
The data suggests that MDMA is at least six months resistant, Yazar-Klosinski said.
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.
There have been allegations that adverse events were not reported. A petition was filed with the FDA calling for an advisory meeting, which had some problems with an unnamed former employee of the company.
“Let’s try to not gloss over this misconduct. It was not merely an act of lust. That’s particularly important,” said Elizabeth Joniak-Grant, a sociologist and a member of the panel.
That report stated that it’s possible those involved in the trials including therapists and investigators encouraged the reporting of positive events and downplayed adverse events.
Dr. Walter Dunn, a psychiatrist at UCLA and a panelist, asked about claims in the ICER report that some participants may have been discouraged from participating 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.”
A panel of experts that advise the US Food and Drug Administration (FDA) on the use of MDMA did not find the evidence to show that the drug was effective or its benefits outweighed its risks. “Although we do have two positive studies, the results are in the context of dramatic functional unblinding,” Dr David Millis, clinical reviewer for the FDA, said.