CARDIO MYOPATHY AND ADVISORY GROUP FOR THE FDA HAS VOTED AGAINST USING PSYCHEDELIC DRUGS TO TREAT POST-TRAUMATIC STRESS DISORDER. IT IS A SETBACK FOR PATIENTS IN A CLINICAL TRIAL WHO SAY THAT THE THERAPY ACTUALLY IMPROVED THEIR SYMPTOMS. HERE TO TALK ABOUT THAT, ANSWER QUESTIONS. DOCTOR MICHELLE DIBLASI, PSYCHIATRIST AT TUFTS MEDICAL CENTER. DOCTOR, IT’S ALWAYS GREAT TO SEE YOU. SO THIS IS THE FIRST TIME THE FDA HAS EVER CONSIDERED APPROVING PSYCHEDELIC DRUGS LIKE ECSTASY AND MOLLY FOR A MEDICAL PURPOSE. COULD THESE AND I’M QUOTING HERE, PARTY DRUGS ACTUALLY HELP PATIENTS. YOU KNOW, MDMA, WHICH IS THE MAIN INGREDIENT IN PSYCHEDELIC DRUGS LIKE ECSTASY OR MOLLY GIVES PEOPLE THIS SORT OF EUPHORIC LIKE FEEL GOOD FEELING. AND WHAT SOME OF THESE STUDIES DID WAS THEY USED THAT FEELING AND USED IT ACTUALLY AS A TREATMENT MODALITY FOR PEOPLE WHO ARE STRUGGLING WITH POST POST-TRAUMATIC STRESS DISORDER, BECAUSE WHAT THEY FOUND WAS WITH THE APPROPRIATE DOSING, THESE PATIENTS COULD ACTUALLY GET BEYOND SOME OF THE NEGATIVE EMOTIONS THEY HAVE FROM THEIR TRAUMATIC EVENTS AND TRULY DELVE INTO THERAPY AND ACTUALLY PROCESS A LOT OF THE THINGS THAT WERE HAPPENING TO THEM. SO IT DID SHOW SOME PROMISE. I KNOW THERE WAS A BIG FOCUS ON DOING THESE TRIALS WITH VETERANS. WHY DID THE FDA’S EXPERTS VOTE AGAINST THIS PROPOSAL? YEAH, SO THEY HAD SEVERAL CONCERNS. YOU KNOW, ONE OF THE BIGGEST CONCERNS THEY HAD WAS THAT A LOT OF THE STUDIES HAD THIS SORT OF BIAS TO IT. I MEAN, IT WAS PRETTY OBVIOUS FOR THE PATIENTS WHO WERE GETTING MDMA, FOR EXAMPLE, THAT THEY KNEW THEY WERE GETTING IT RIGHT BECAUSE IT’S THIS VERY CLEAR, EUPHORIC FEELING. AND SO THAT THEY FELT LIKE BIASED. A LOT OF THE STUDIES. AND THE OTHER THING WAS SAFETY CONCERNS. THEY JUST DIDN’T HAVE ENOUGH DATA TO SHOW WHAT WOULD HAPPEN IN TERMS OF ABUSING THESE MEDICATIONS OR FOR YOUR HEART OR LIVER HEALTH. SO THERE JUST NEEDED TO BE MORE DATA IN THIS AREA. SO SO DOCTOR, GIVEN ALL OF THAT, WHAT HAPPENS NEXT? LOOKED INTO THE CRYSTAL BALL. WHAT HAPPENS NEXT. SO THE FDA ULTIMATELY WILL MAKE THE DECISION RIGHT. BUT THEY’RE GOING TO SERIOUSLY CONSIDER WHAT THE FDA ADVISERS ARE SAYING. AND THEY’RE GOING TO TAKE THEIR OPINIONS AND CONCERNS INTO ACCOUNT. BUT I DO THINK THAT THIS IS A REALLY BIG AREA OF PROMISE. AND I THINK IT’S A GREAT AREA OF GROWTH TO REALLY EXPLORE THESE PSYCHEDELIC DRUGS AND SEE IF THEY COULD ACTUALLY BE USED AS TOOLS TO HELP PEOPLE WHO ARE REALLY CRIPPLED WITH THESE SERIOUS MENTAL HEALTH DISORDERS. SO I THINK MORE TO COME. ALL RIGHT. WE’LL BE WATCHING TO SEE WHAT COMES ABOUT. THANK YOU SO MUC
Advertisem*nt
More illnesses linked to Diamond Shruumz chocolate, cones and gummies, FDA says
The U.S. Food and Drug Administration is warning consumers and retailers to not "eat, sell or serve" any of Diamond Shruumz-brand's microdosing chocolate bars, infused cones and microdose and macrodose gummies after people across eight states were left hospitalized.Video above: Doctor weighs on using psychedelic drugs to treat PTSDTwelve people reported falling ill after eating Diamond Shruumz's products, the FDA said in an advisory. Cases include four people in Arizona, two in Indiana, and one each in Alabama, Missouri, Kentucky, Nevada, Pennsylvania and South Carolina. Out of the dozen cases, 10 people have been hospitalized.People who consumed the products reported experiencing symptoms such as "seizures, central nervous system depression (loss of consciousness, confusion, sleepiness), agitation, abnormal heart rates, hyper and hypotension, nausea and vomiting," said the FDA.No deaths linked to the products have been reported.Microdosing is the act of taking a small amount of psychedelic drugs such as psilocybin mushrooms. People who microdose say these tiny doses can improve mood and concentration.According to the company's website, Diamond Shruumz's products are made with a "proprietary blend of nootropic and functional mushrooms" and do not contain "psilocybin, amanita or any scheduled drugs."The FDA is currently investigating the illnesses alongside the U.S. Centers for Disease Control and Prevention, America's Poison Centers and state and local partners.CNN has reached out to Diamond Shruumz for comment.If a person becomes ill after consuming Diamond Shruumz's chocolate bars, the FDA recommends speaking to a healthcare provider or contacting the Poison Help Line at 1-800-222-1222.CNN's Carma Hassan contributed to this report.
The U.S. Food and Drug Administration is warning consumers and retailers to not "eat, sell or serve" any of Diamond Shruumz-brand's microdosing chocolate bars, infused cones and microdose and macrodose gummies after people across eight states were left hospitalized.
Video above: Doctor weighs on using psychedelic drugs to treat PTSD
Advertisem*nt
Twelve people reported falling ill after eating Diamond Shruumz's products, the FDA said in an advisory. Cases include four people in Arizona, two in Indiana, and one each in Alabama, Missouri, Kentucky, Nevada, Pennsylvania and South Carolina. Out of the dozen cases, 10 people have been hospitalized.
People who consumed the products reported experiencing symptoms such as "seizures, central nervous system depression (loss of consciousness, confusion, sleepiness), agitation, abnormal heart rates, hyper and hypotension, nausea and vomiting," said the FDA.
No deaths linked to the products have been reported.
Microdosing is the act of taking a small amount of psychedelic drugs such as psilocybin mushrooms. People who microdose say these tiny doses can improve mood and concentration.
According to the company's website, Diamond Shruumz's products are made with a "proprietary blend of nootropic and functional mushrooms" and do not contain "psilocybin, amanita or any scheduled drugs."
The FDA is currently investigating the illnesses alongside the U.S. Centers for Disease Control and Prevention, America's Poison Centers and state and local partners.
CNN has reached out to Diamond Shruumz for comment.
If a person becomes ill after consuming Diamond Shruumz's chocolate bars, the FDA recommends speaking to a healthcare provider or contacting the Poison Help Line at 1-800-222-1222.
CNN's Carma Hassan contributed to this report.
