FDA Reviewing Data on MDMA for Potential Approval of Groundbreaking PTSD Treatment
Video Credit: Wibbitz Top Stories - Duration: 01:30s - Published
FDA Reviewing Data on MDMA for Potential Approval of Groundbreaking PTSD Treatment
FDA Reviewing Data on MDMA , for Potential Approval of , Groundbreaking PTSD Treatment.
'The Independent' reports that federal health advisers are
considering a first-ever approval of MDMA, a psychedelic
drug, to treat post traumatic stress disorder (PTSD).
'The Independent' reports that federal health advisers are
considering a first-ever approval of MDMA, a psychedelic
drug, to treat post traumatic stress disorder (PTSD).
The news comes after decades of
psychedelic advocates urging regulators
to give the drug medical acceptance.
.
On June 4, the Food and Drug Administration
(FDA) called on a group of outside experts
to review the latest MDMA research.
.
The research suggests that when the drug is paired with talk therapy, it can help alleviate PTSD.
.
However, regulators at the FDA have questioned the
reliability of the data, as well as the potential safety risks,
which include possible heart problems and addiction.
FDA approval could open the door for federal
approval to be granted as soon as this summer.
.
Approval would make MDMA, often referred to as
ecstasy or molly, the first illegal psychedelic
to receive approval for mainstream medicine.
.
'The Independent' reports that a number of
psychedelics are expected to receive FDA
reviews in the coming years amid interest in their
potential to treat depression, anxiety and addiction.
'The Independent' reports that a number of
psychedelics are expected to receive FDA
reviews in the coming years amid interest in their
potential to treat depression, anxiety and addiction.
It’s clear that MDMA-assisted
therapy would be a welcome
addition to the currently
available options, Dr. Kelley O'Donnell, a New York University psychiatrist who
helped conduct the MDMA studies, via 'The Independent'.
I’ve seen firsthand
how this treatment can
be lifesaving for some, Dr. Kelley O'Donnell, a New York University psychiatrist who
helped conduct the MDMA studies, via 'The Independent'
Supreme Court Upholds , FDA Regulation on Popular , Abortion Drug Mifepristone.
On June 13, the Supreme Court ruled against a group of
doctors who challenged the Food and Drug Administration's
(FDA) regulations on the abortion pill mifepristone.
CBS reports that the case once again highlighted
abortion access following the conservative
majority decision to overturn Roe v. Wade in 2022.
The court ruled unanimously that the group of
anti-abortion rights doctors and medical associations
lacked the legal right to challenge the FDA. .
However, the court also did not address
whether the FDA's decision to relax the
rules for mifepristone's use were lawful. .
The latest ruling was authored
by Justice Brett Kavanaugh. .
Under Article III of the Constitution,
a plaintiff's desire to make a drug
less available for others does
not establish standing to sue. , Justice Brett Kavanaugh writing for the court, via CBS.
Nor do the plaintiffs' other
standing theories suffice.
Therefore, the plaintiffs lack
standing to challenge FDA's actions, Justice Brett Kavanaugh writing for the court, via CBS.
CBS reports that the ruling does not impact other
challenges to the FDA's standing on mifepristone,
while preserving access to the popular abortion medication.
In 2016 and 2021, the FDA took steps to widen access
to mifepristone, which has been taken by over
5 million patients since first being approved in 2000.
Those steps included allowing the drug to be taken up to 10
weeks into a pregnancy, reducing the number of in-person
doctor visits and permitting it to be sold through the mail.
Credit: Wibbitz Top Stories Duration: 01:30Published
Microdose Chocolate , May Cause Seizures, FDA Warns.
The FDA says that several people in
four states have gotten sick after eating Diamond Shruumz chocolate bars.
Severe symptoms experienced by the victims include "seizures, central nervous system depression, agitation, abnormal heart rates, hyper/hypotension, nausea and vomiting," CBS News reports. .
The chocolate, which is sold across the country, landed six of the eight victims in the hospital. .
The company's website says that the chocolate
is manufactured with a "primo proprietary blend
of nootropic and functional mushrooms.".
In 2022, the FDA called nootropics "a term widely used to market unapproved products as 'smart drugs' and 'cognitive enhancers.'".
On June 7, the FDA warned parents to
keep their kids away from the chocolate
which is marketed as candy. .
Parents and caregivers should consider
discussing the information in this
advisory with their children and take
extra care to avoid this product being
consumed by younger people. , FDA, via statement.
Half of the victims were in
Arizona, CBS News reports. .
While these products claim to
contain only natural ingredients
and no scheduled drugs, there is
clearly something toxic occurring, Steve Dudley, director of the Arizona Poison and
Drug Information Center, via news release.
We've seen the same phenomenon
of people eating the chocolate bar
then seizing, losing consciousness,
and having to be intubated, Steve Dudley, director of the Arizona Poison and
Drug Information Center, via news release
Credit: Wibbitz Top Stories Duration: 01:30Published
FDA Reverses Ban , on Juul E-Cigarettes.
On June 6, the Food and Drug Administration
announced that it has reversed its ban on Juul
e-cigarettes while the agency reviews new information.
On June 6, the Food and Drug Administration
announced that it has reversed its ban on Juul
e-cigarettes while the agency reviews new information.
NBC reports that the FDA first ordered Juul to take its
product off the market in 2022, however the e-cigarettes
have remained on shelves pending the company's appeal.
NBC reports that the FDA first ordered Juul to take its
product off the market in 2022, however the e-cigarettes
have remained on shelves pending the company's appeal.
In that time, Juul has maintained
its position as the second-most
popular e-cigarette in the U.S.
The FDA noted that reversing the ban
temporarily was not an indication that the
company's product would be ultimately cleared. .
The FDA noted that reversing the ban
temporarily was not an indication that the
company's product would be ultimately cleared. .
Sales of alternative nicotine
products, like e-cigarettes, have
continued to grow in the past decade. .
In 2023, the Centers for Disease Control and
Prevention reported that e-cigarette use had
grown by almost 50% between 2020 and 2022. .
In 2023, the Centers for Disease Control and
Prevention reported that e-cigarette use had
grown by almost 50% between 2020 and 2022. .
Juul released a statement
following the FDA reversal, .
... saying the company looks forward to "re-engaging
with the agency on a science- and evidence-based
process to pursue a marketing authorization.".
We remain confident in the quality
and substance of our applications
and believe that a full review of
the science and evidence will
demonstrate that our products
meet the statutory standard
of being appropriate for
the protection of public health, Juul statement, via NBC.
We remain confident in the quality
and substance of our applications
and believe that a full review of
the science and evidence will
demonstrate that our products
meet the statutory standard
of being appropriate for
the protection of public health, Juul statement, via NBC.
'The Wall Street Journal' reports that Juul has argued
that the 2022 ban significantly disrupted the company's
finances, resulting in an investor bailout.
Currently, the FDA has only granted approval for 23
e-cigarette products, manufactured by only three
companies, to be marketed and sold to consumers
Credit: Wibbitz Top Stories Duration: 01:31Published
Cucumbers Are Recalled , in 14 States.
Fresh Start Produce Sales in Florida is
recalling cucumbers over possible salmonella contamination, 'Newsweek' reports.
The 14 states affected by the recall include Alabama, Florida, Georgia, Illinois, Maryland, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Virginia and West Virginia.
Only large, whole cucumbers
are included in the recall.
Mini and English cucumbers
are considered safe to eat.
The Pennsylvania Department of Agriculture first informed Fresh Start that its product tested positive for salmonella.
The FDA is conducting whole genome
sequencing to determine if this sample
is related to an ongoing salmonella
outbreak investigation, Via recall notice.
Fresh Start believes it recalled the product before it could make it into consumers' hands.
Although these cucumbers are
unlikely [to be found] in the
marketplace, anyone with the
recalled product should not
consume it and should destroy
and discard it or return it to the
place of purchase for a refund, Fresh Start Produce Sales, via statement.
Consumers should check with their
retailer or place of purchase to
determine whether the recalled
cucumbers were sold where they shop, Fresh Start Produce Sales, via statement
Credit: Wibbitz Top Stories Duration: 01:31Published
ISS Crew Forced to , Take Shelter , After Russian Satellite Breaks Apart.
'The Independent' reports that astronauts aboard the
International Space Station (ISS) took shelter due to
the danger of debris from a broken up Russian satellite.
Crews aboard the ISS were ordered to board
their respective spacecraft in case debris
struck and damaged the orbital laboratory.
According to experts, the ever-increasing number of
satellites in orbit around Earth has magnified the risk of
collision and other potential problems for space crews.
It remains unclear what caused
the RESURS-P1 Russian Earth
Observation satellite to break apart. .
According to NASA's Space Station office, the event
occurred near the space station, prompting astronauts
to take shelter in their spacecraft for about an hour. .
Mission Control continued to monitor the path of the debris, and after about an hour, the crew was cleared to exit their spacecraft and the station resumed normal operations, NASA statement, via X.
Space-tracking firm LeoLabs said that U.S. radar
detected the decommissioned satellite releasing a
cloud of debris in low-Earth orbit late on June 26. .
Shortly after 9 p.m. EDT, NASA
instructed crews aboard the space
station to shelter in their respective
spacecraft as a standard precautionary
measure after it was informed
of a satellite break-up at an
altitude near the station, NASA statement, via X.
According to U.S. Space Command, the Russian satellite created , "over 100 pieces of trackable debris.".
USSPACECOM has observed no
immediate threats and is continuing
to conduct routine conjunction
assessments to support the safety
and sustainability of the space domain, U.S. Space Command statement, via 'The Independent'
Credit: Wibbitz Top Stories Duration: 01:31Published
Taylor Swift Addresses Dave Grohl’s Claim , That She Doesn’t Play Live.
Taylor Swift Addresses Dave Grohl’s Claim , That She Doesn’t Play Live.
On June 22, Grohl referred to the
Foo Fighters' show in London as the
"Errors Tour," according to 'The Independent.'.
His comment stemmed from having a
"few more eras and more than a few f------ errors.”.
The 55-year-old frontman went
on to say, “we actually play live.”.
Swifties took to social media
to slam Grohl's comments.
Oh Tayvoodoo is coming for him and he
deserves it. Can’t handle that a woman
is more talented and successful, Taylor Swift fan, via X.
Wow Grohl so washed he has to
use Taylor’s name for free pr?
Embarrassing thought he was
better than that what a shame, Taylor Swift fan, via X.
On June 23, Swift seemed to address Grohl's comments on stage while performing at Wembley. .
She said that her band
deserves "so much" praise.
What you just did is an unforgettable moment
in not just my life, but every very single one of
our crew. The band that’s going to be playing
live for you for three and a half hours tonight, Taylor Swift, via 'The Independent'.
They deserve this so much and so does every
one of my fellow performers, and you just gave
that to us so generously. We’ll never forget it, Taylor Swift, via 'The Independent'
Credit: Wibbitz Top Stories Duration: 01:31Published
Julian Assange , Reaches Plea Deal With , US Government.
'The Independent' reports that Wikileaks
founder Julian Assange has been released
from Belmarsh prison as part of a plea deal
with the United States Justice Department.
Assange will be flown out of the U.K. as part
of the deal before he makes a guilty plea deal
that could end the years-long legal battle.
On June 24, Assange boarded a flight at Stansted airport
ahead of a scheduled appearance later this week in the
Mariana Islands, a Western Pacific U.S. commonwealth.
The U.S. government has charged the
Wikileaks founder with conspiracy to obtain
and disclose national defense secrets.
The charges stem from one of the largest leaks of
classified information in U.S. history, disclosing tens of
thousands of reports regarding the war in Afghanistan.
The disclosure, which occurred between 2009 and
2011, included unfiltered diplomatic cables that
potentially endangered the safety of confidential sources. .
The leak also included significant
activity reports related to the war in Iraq
and information regarding Guantanamo Bay.
According to the latest DOJ filing, Assange is expected
to plead guilty and be sentenced to 62 months of time
already served, thus avoiding U.S. imprisonment. .
This is the result of a global campaign
that spanned grass-roots organizers,
press freedom campaigners,
legislators and leaders from
across the political spectrum,
all the way to the United Nations, Wikileaks statement, via X.
After more than five years in
a 2x3 metre cell, isolated 23 hours
a day, he will soon reunite with his
wife Stella Assange, and their children,
who have only known their
father from behind bars, Wikileaks statement, via X
Credit: Wibbitz Top Stories Duration: 01:31Published
Important Things to Know , About Dangerous Ocean, Rip Currents.
'The Independent' reports that rip currents pose
the greatest danger to beachgoers,
accounting for the most beach rescues every year. .
Over a recent two-day period in Florida,
six people drowned in rip currents.
Every year, about 100 people drown
because of rip currents in the United States
according to the U.S. Lifesaving Association.
Over 80% of beach rescues
involve rip currents every year.
So far in 2024, the National
Weather Service has listed 16 deaths
from rip currents in U.S. waters. .
A rip current is a narrow column of water that
flows rapidly away from the beach, which are capable
of pulling swimmers a fair distance from the shore.
Rip currents normally form
at low spots along the beach
or along jetties and piers.
While sometimes associated
with stormy weather, they can
also occur on sunny, clear days.
Rip currents are also difficult to
detect as the surface water near
them often appears to be calm. .
'The Independent' reports that the best advice to escape a
rip current is to try and swim parallel to the shore and not
to tire yourself out before having to swim back to land. .
'The Independent' reports that the best advice to escape a
rip current is to try and swim parallel to the shore and not
to tire yourself out before having to swim back to land.
Credit: Wibbitz Top Stories Duration: 01:31Published
FAA Investigating Southwest-Operated, Boeing 737 , That Flew Dangerously Low.
'The Independent' reports that a Southwest Airlines
passenger jet flew extremely low over a suburb of
Oklahoma City, triggering an altitude alert on June 19.
According to Flightradar24, the Boeing 737-800
descended to just 525 feet above the ground
on its way to Will Rogers World Airport.
Approximately nine miles from the airport,
the plane was passing over Yukon when it triggered
an automated warning around 12:05 a.m. local time. .
Altitude alerts are triggered when an aircraft
descends to within an unsafe distance
to terrain, obstructions or other aircraft. .
'The Independent' reports that the pilots quickly
regained altitude and circled around for a safe
landing on another runway shortly after midnight.
The incident, which sparked concern
in communities it passed over,
is now being investigated. .
On June 20, Southwest Airlines
confirmed that it was in contact
with the FAA regarding the situation.
Southwest is following
its robust Safety
Management System
and is in contact with the
Federal Aviation Administration.., Southwest spokesperson, via 'The Independent'.
... to understand and address any
irregularities with the aircraft’s
approach to the airport. , Southwest spokesperson, via 'The Independent'.
Nothing is more important
to Southwest than the safety
of our customers and employees, Southwest spokesperson, via 'The Independent'
Credit: Wibbitz Top Stories Duration: 01:31Published
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