Health
FDA Considers Legalizing MDMA Therapy for PTSD Treatment
United States: Currently, the FDA has not made specific decisions on this research yet, but it is considering the idea that prescribers may be allowed to prescribe the substance that is used to produce MDMA or Ecstasy for the treatment of PTSD.
More about the finding
A scholarly panel of the agency that advises on research deliberated on studies on June 4 and approved the treatment totally. However, it is noteworthy that the FDA usually pays considerable attention to the suggestions of its advisory committees, as the New York Times reported.
The decision on this case is still pending and should be made in mid-August.
Lykos Therapeutics provided data from clinical trials to the agency in an attempt to get approval for the substance to be sold under legal jurisdiction to be administered to individuals who have taken MDMA alongside talk therapy.
Data indicate that millions of people in the United States live with PTSD, such as former military who attempt suicide most frequently. In fact, there has been a lack of a new treatment for PTSD for nearly 20 years.
As a matter of fact, millions from America are suffering from PTSD, including military veterans as well, who are considered at high risk of suicide, according to a recent report.
Moreover, no other treatment for PTSD has been approved in more than 20 years.
Know more about MDMA
Methylenedioxymethamphetamine (MDMA) is a synthetic, psychoactive substance synthesized for the first time by Merck in 1912.
Originally synthesized in the 1920s by chemists working for the pharmaceutical company Merck, it was forgotten until its revival in the mid-1970s by a psychedelic chemist called Alexander Shulgin in the Bay area of San Francisco, where it rapidly became popular among therapists.
In the initial trials, signs of a robust therapeutic value were aimed toward the treatment of a number of psychological disorders, as the New York Times reported.
MDMA is classified as an entactogen or empathogen and has beneficial effects that enhance self-realization, intimacy, and oneness with others.
It is not one of the groups that contain substances such as acid or shrooms, drugs that can create different realities and visions. Depending on the parts of the world where it is commonly used and the drugs and substance market, MDMA commonly goes by the moniker Molly or Ecstasy.
MDMA reached Britain in 1985 during the second wave of rave culture; it was also stated that the Drug Enforcement Administration has classified the drug as Schedule I; the substance is defined as having no medicinal use, and the effectiveness for usage is deemed high.
Negative effects on health
The FDA officials highlighted worries regarding “significant increases” in terms of blood pressure and pulse rates in those of the participating individuals in the Lykos clinical trials, where they noted about the risks that could “trigger cardiovascular events.”
Several scientists suggest the drug is a safe and nonaddictive entity in its pure form.
However, negative health effects, which are often observed outside of safe clinical settings, are noticed when the drug is used with other adulterants, such as methamphetamine and synthetic cathinone, often known as bath salts.
Some recreational users also report lower mood after consuming MDMA, majorly due to the time-consuming storage of serotonin in the brain. Experts believe that more research is still required to gain a better understanding of this area.
Health
Mpox Vaccine Breakthrough: Hope for Global Eradication
United States: The World Health Organization said on Friday that it had approved its first shot of vaccines against the mpox for use in adults, saying that it is a progression toward eradicating the disease in Africa.
More about the news
This approval is significant for organizations like Vaccines Alliance Gavi and UNICEF as they can now purchase it from Bavarian Nordic A/S.
Buying supplies is, however, a challenge since the product is manufactured by only one company.
According to WHO Director-General Tedros Adhanom Ghebreyesus, “This first (authorization) of a vaccine against mpox is an important step in our fight against the disease, both in the context of the current outbreaks in Africa and in future,” ABC News reported.
Previously, the UN health agency endorsed the two-dose mpox vaccine targeting the adult population who are 18 years and above. As for WHO, even though they did not advise the use of the vaccine for people below the age of 18, in particular cases, vaccines can be given to infants, children, and adolescents “in outbreak settings where the benefits of vaccination outweigh the potential risks.”
What more has the WHO recommended?
The WHO has also pointed out that it has been making an “access and allocation mechanism” to execute an even and fair distribution of mpox tests, treatments, and vaccines to the countries that need them most.
WHO has suggested that a dose could be split in the event that there is a shortage of the vaccine since one dose was proven to be 50 percent effective, and it is important to gather more information on the efficacy of the vaccine when used as a single shot.
About the vaccine
The Bavarian Nordic mpox vaccine was earlier named and approved by several developed countries in Europe and North America during the mpox outbreak in the year 2022.
In millions of adults, doses have proven that the vaccine assists in decelerating the virus distribution, but little is known about children.
Director-general of the Africa Center for Disease Control and Prevention said last month that seventy percent of the patients are below the age of 15 in Congo, where the outbreak is most severe, and children under the age of 15 are the majority of fatalities at 85 percent.
However, the WHO noted that more than 120 countries had confirmed more than 103 thousand legion cases of mpox since the start of the outbreak two years ago, ABC News reported.
As of Sunday, it recorded 723 people in well over a dozen countries in Africa have perished from the disease.
Health
9/11 Dust Exposure Linked to 14x Higher Dementia Risk
United States: The World Trade Center Health Program has been covering the medical expenses for cancer, respiratory ailments, mental health conditions, and musculoskeletal disorders linked to work at the site ever since it was established by an act of Congress and signed into law by President Barack Obama in 2011.
More around the news
Recently, researchers have started to look into cognitive impairment and dementia afflicting first responders at rates far higher than in the general population.
The study findings are urging healthcare providers to be more expressive regarding lobbying the World Trade Center Health Program, which is overseen by the CDC, to include dementia among the illnesses covered.
What more are the experts stating?
According to Benjamin Luft, the director of a program at Stony Brook University that cares for and monitors the health of first responders, “I’m hoping they will,” and “They have a systematic process in which they evaluate the scientific data. We’ve spent a huge amount of time and effort to establish that exposure to the neurotoxins and dust could cause these problems, and so should be eligible for coverage,” the Washington Post reported.
Lust has been working as a senior author of a study whose findings were published this summer and involved more than five thousand respondents who regularly undergone tests for over a decade.
They found that the ones with maximum exposure to the dust, as well as neurotoxic debris at the WTC, would have fourteen times more chances of becoming infected with dementia before the age of 65.
As per Ray Dorsey, a professor of neurology at the University of Rochester, the small-sized ordinary dust particles, which are termed fine particulate matter, could enter the nose and reach the brain to cause damage, the Washington Post reported.
However, as Dorsey said, “The nose is the front door to our brain,” and “Dust and chemicals set up shop in the small area of our brain, then spread to the parts of the brain important for memory.”
Health
FDA Approves Controversial Childhood Obesity Drug
United States: A drug has recently received approval for the treatment of obesity in adults and teenagers. It has been proven to be efficient for kids starting from the age of six when taken together with the necessary lifestyle changes – a new study found.
More about the news
A medication called liraglutide, used in adults with obesity, reduced body mass, attenuated weight gain, and enhanced favorable biomarkers in children aged between six and eleven years, research reported in a medical conference on Tuesday, and to the New England Journal of Medicine, ABC News reported.
Following the trial, the company that manufactures the drug, Novo Nordisk, has sought permission from the US authorities to apply the medication in children in that age bracket, the spokesperson said on Tuesday.
Should the medication be approved, it would be the first treatment for the kind of obesity experienced by over 20 percent of kids in the age group of 6 through 11 in the United States, according to the US CDC.
What do the study results show?
According to Dr. Claudia Fox, a pediatric obesity expert at the University of Minnesota, who led the study, “To date, children have had virtually no options for treating obesity,” and “They have been told to ‘try harder’ with diet and exercise,” ABC News reported.
Like most drugs with antiemetic properties, side effects include gastrointestinal effects in those administered the drug, including nausea, vomiting, and diarrhea, among others.
However, physicians and parents would have to research those risks and the absence of knowledge about the safety of employing such drugs in young children.
According to Dr. Melissa Crocker, a pediatric obesity specialist at Boston Children’s Hospital, “Having a medication for that age group, if approved, would be a really nice tool to have, but we’re also going to have to be careful about how widely we start using it,” ABC News reported.
“And I would answer that differently at six than I would at 11,” she added.
About Liraglutide
Liraglutide belongs to a class of drugs known as GLP-1s, which currently boast some of the biggest-selling drugs in the world, such as Wegovy and Mounjaro.
The medications make them resemble hormones that control hunger, feelings of being full or satiated, and digestion. Although this drug is given as a daily injection, it has been approved under the name of Victoza as a treatment for diabetes in adults and in children that are at least ten years of age and for Saxenda under the treatment of obesity affecting adults and children aged between 12 to 17 years.
The new study, also funded by Novo Nordisk, enrolled 82 children with a mean age of 10 and a baseline weight of 70kgs or 154. 2 pounds. In this sample, the average starting BMI was 31, categorizing the childhood population as obese or overweight.
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