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Tag: Medication

  • Central Florida doctor unveils kratom research findings, potential dangers

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    Central Florida doctor unveils kratom research findings, potential dangers

    Orlando Health Orlando Regional Medical Center emergency medicine physician and toxicologist, Dr. Josef Thundiyil, joins WESH 2 to discuss the potential dangers of kratom.

    ALERT AND FOCUSING ON A SUBSTANCE CALLED KRATOM. ACCORDING TO THE U.S. FOOD AND DRUG ADMINISTRATION, THE FDA HERE SAYS THIS SUPPLEMENT IS TYPICALLY MARKETED AS AN ENERGY BOOSTER, MOOD LIFTER, PAIN RELIEVER, AND OPIOID WITHDRAWAL REMEDY. IT’S FOUND AT DISPENSARIES, EVEN RESTAURANTS, SOMETIMES INFUSED WITH DRINKS. AND DESPITE ITS GROWING POPULARITY, THERE ARE MANY QUESTIONS WHEN IT COMES TO THE SUBSTANCE. SO HERE TO GIVE US ANSWERS AND SHARE RESEARCH AND FINDINGS, WE HAVE EMERGENCY MEDICINE PHYSICIAN AND TOXICOLOGIST AT ORLANDO REGIONAL MEDICAL CENTER, DOCTOR JOSEPH DUNHILL. GREAT TO SEE YOU, DOCTOR. THANK YOU FOR HAVING ME. OKAY, SO YOU’VE DONE THE WORK HERE. THIS IS SOMETHING THAT WE’VE HEARD A GOOD BIT ABOUT LATELY. THE KRATOM PRODUCTS. WHAT ARE YOUR FINDINGS IN TERMS OF LOOKING INTO THIS SUBSTANCE THAT IS REALLY WIDELY POPULAR AND WIDELY AVAILABLE? YEAH. AS A BACKGROUND, THERE’S A FEW CONCERNS THAT HAVE COME UP. NUMBER ONE, IT’S VERY UNREGULATED. THERE’S ABOUT 40 DIFFERENT CHEMICAL ALKALOIDS IN THIS. THE SECOND IS THAT WE KNOW IT’S ADDICTIVE. SOME OF THE REPORTS FROM PEOPLE IS THAT IT’S COMPULSIVELY ADDICTIVE. PEOPLE SPENDING HUNDREDS OF DOLLARS A DAY TO GET SORT OF A FIX WITH IT. THE OTHER THING WE KNOW IS THAT IT INTERACTS WITH EXISTING MEDICATIONS THAT MANY PEOPLE ARE ON. WE DON’T KNOW EXACTLY WHAT THOSE INTERACTIONS ARE. AND THEN THE FINAL THING, EVEN BEFORE I GOT INTO THIS RESEARCH, IS THAT WE KNOW THAT THERE’S NO PROVEN MEDICAL BENEFITS. SO PEOPLE ARE USING THIS WITH THE THOUGHT IT MIGHT BE HELPING, BUT WE DON’T KNOW THAT IT’S HELPING THEM WITH ANYTHING. AND YOU WORKED WITH A LOT OF MEDICAL PROFESSIONALS TO PUT THIS TOGETHER. MORE THAN TWO DOZEN, I BELIEVE. YEAH. WE WORKED ACTUALLY. IT WAS A GROUP OF US PHYSICIANS. WE ESSENTIALLY REACHED OUT TO 25 MEDICAL EXAMINERS IN THE STATE OF FLORIDA. REALLY TO TRY TO ANSWER THE QUESTION IS, ARE PEOPLE DYING FROM KRATOM? AND WE FOUND SOME VERY INTERESTING THINGS. WE ACTUALLY HAD THE MEDICAL EXAMINER SEND US ANY REPORTED DEATHS, AND WE FOUND ALMOST 40 DEATHS IN THE STATE OF FLORIDA OVER A PERIOD OF ABOUT FIVE YEARS. OKAY. AND WAS THIS TIED TO ANYTHING SPECIFIC? THE SUBSTANCE AND OPIOIDS OR ANYTHING ALONG THOSE LINES? NO, THESE ARE DEATHS IN THE ABSENCE OF OPIOIDS. NOW, WE KNOW THAT THE CHEMICAL STRUCTURE RESEMBLES OPIOIDS. AND THAT’S WHAT GAVE US THIS CONCERN THAT IT COULD CAUSE DEATH. AND WE STILL ARE LEFT WITH NOT KNOWING EXACTLY WHY SOME PEOPLE DIE AND SOME PEOPLE DON’T. BUT THE BOTTOM LINE IS IT STILL HAS SOME SIGNIFICANT DANGERS WITH IT. RIGHT. AND, YOU KNOW, AS A PHYSICIAN, YOU KNOW, WHAT IS YOUR ADVICE TO SOMEONE WHO’S, YOU KNOW, THERE’S SOMETHING THAT MAY CAUSE SOMETHING AS SEVERE AS DEATH? WHAT WHAT ARE YOU ADVISING PEOPLE? I WOULD ADVISE TREMENDOUS CAUTION. IT IS UNREGULATED. MOST OF THESE PRODUCTS DON’T HAVE ANY DOSING LISTED ON IT. WE KNOW IT INTERACTS WITH MEDICATIONS. YOU KNOW, MY TYPICAL ADVICE WOULD BE TALK TO YOUR PHYSICIAN ABOUT IT. BUT WHAT I’M FINDING IN THE COMMUNITY IS THIS THERE’S ENOUGH UNKNOWNS ABOUT THE SUBSTANCE THAT EVEN YOUR PHYSICIAN MAY NOT KNOW WHAT ALL THE INTERACTIONS WITH OTHER SUBSTANCES ARE. SO MAKE SURE YOU KNOW WHAT THEY ARE. AND AT THE MOMENT, I PERSONALLY WOULD ADVOCATE FOR SAFETY. BE VERY, VERY CAREFUL WITH THIS BECAUSE WE KNOW THERE IS HARM. WE KNOW THERE’S ADDICTION. ANYTIME THERE’S A POTENTIAL FOR ADDICTION AND ESCALATING USE, WE NOW KNOW THAT IT CAN ALSO CAUSE DEATH. YEAH. WHAT ARE THE MOST VULNERABLE POPULATIONS YOU’RE SEEING WHEN IT COMES TO THE SUBSTANCE? YEAH. FROM A PUBLIC HEALTH STANDPOINT, WE ALWAYS THINK ABOUT VULNERABLE POPULATIONS IN TERMS OF WHO MIGHT BE AT RISK. SO PEOPLE WHO ALREADY SUFFER FROM ADDICTION BECAUSE THEY MAY BE LOOKING FOR ANYTHING TO HELP THEM GET OFF OF SUBSTANCE USE. I ALWAYS AM CONCERNED ABOUT ADOLESCENTS AND YOUNG ADULTS. FOR THIS REASON, PEOPLE WHO ARE ON OTHER MEDICATIONS BECAUSE OF THE POTENTIAL TO INTERACT. AND SO THAT INCLUDES NOT ONLY YOUNG PEOPLE WHO ARE ON MEDICINES, BUT ESPECIALLY PEOPLE WHO ARE OLDER AND THE ELDERLY. THOSE ARE SOME OF THE HIGHEST RISK GROUPS THAT WE GET CONCERNED ABOUT. YEAH, WELL, THIS IS REALLY AMAZING FINDINGS AND GREAT RESEARCH THAT YOU AND ALL THESE OTHER PHYSICIANS AND MEDICAL EXAMINERS HAVE WORKED ON COLLECTIVELY. WE’RE GOING TO POST SOME MORE INFORMATION ON OUR WEBSITE SO YOU CAN FIND OUT AND HELP NAVIGATE YOUR JOURNEY. IF YOU IF YOU HAV

    Central Florida doctor unveils kratom research findings, potential dangers

    Orlando Health Orlando Regional Medical Center emergency medicine physician and toxicologist, Dr. Josef Thundiyil, joins WESH 2 to discuss the potential dangers of kratom.

    Updated: 10:00 AM EDT Sep 15, 2025

    Editorial Standards ⓘ

    Orlando Health Orlando Regional Medical Center emergency medicine physician and toxicologist, Dr. Josef Thundiyil, joins WESH 2 to discuss the potential dangers of kratom.Click here to learn more.

    Orlando Health Orlando Regional Medical Center emergency medicine physician and toxicologist, Dr. Josef Thundiyil, joins WESH 2 to discuss the potential dangers of kratom.

    Click here to learn more.

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  • Meth burn by FBI smokes out Montana animal shelter

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    BILLINGS, Mont. — A cloud of smoke from two pounds of methamphetamine seized by the FBI and incinerated inside a Montana animal shelter sent its workers to the hospital, city officials in Billings said.

    The smoke started to fill the building during a drug burn on Wednesday, apparently because of negative pressure that sucked it back inside, Billings Assistant City Administrator Kevin Iffland said Friday. A fan was supposed to be on hand in such situations to reverse the pressure so smoke would flow out of the building, but Iffland said it wasn’t readily available.

    The incinerator is used primarily to burn carcasses of animals euthanized or collected by the city’s animal control division. But every couple of months local law enforcement or FBI agents use it to burn seized narcotics, Iffland said.

    Fourteen workers from the nonprofit Yellowstone Valley Animal Shelter evacuated and went to the hospital. The shelter’s 75 dogs and cats were relocated or put into foster homes, said Iffland and shelter director Triniti Halverson.

    The shelter shares space with Billings’ animal control division. When smoke started filling parts of the building, Halverson assumed it was from burning carcasses because she said they had never known about the drug burns.

    Halverson said she had a very intense headache and sore throat, and others had dizziness, sweating and coughing.

    “Not a party,” she said.

    The workers found out it was methamphetamine smoke through a call from a city official while they were the hospital, Halverson said. Most of the staff spent several hours in an oxygen chamber for treatment.

    Symptoms have lingered for some workers, Halverson said.

    They also were closely monitoring four litters of kittens that got more heavily exposed because they were in a closed room with lots of smoke, she said.

    The FBI routinely uses outside facilities to conduct controlled drug evidence burns, agency spokesperson Sandra Barker said. She referred further questions to Billings officials.

    A city animal control supervisor who was present for Wednesday’s burn declined to go the hospital, Iffland said. The FBI agents were told to go to the hospital by their supervisor.

    The incinerator is meant to operate at a certain temperature so it doesn’t emit toxins. Iffland said officials were trying to determine if it was at the appropriate temperature Wednesday.

    The shelter will remain closed until it can be tested for contamination. Shelter workers were tested for potential exposure, and Iffland said he did not know the results.

    Billings resident Jay Ettlemen went to the shelter on Friday to donate dog food and said he was angry when he found out about the drug burns.

    “Why the hell are they destroying drugs inside the city limits?” Ettlemen asked. “There’s so many other places in the middle of nowhere.”

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  • Australia approves world-first vaccine to save koalas from chlamydia

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    MELBOURNE, Australia — A regulator has approved a world-first vaccine to protect koalas from chlamydia infections, which are causing infertility and death in the iconic native species that is listed as endangered in parts of Australia.

    The single-dose vaccine was developed by the University of the Sunshine Coast in Queensland state after more than a decade of research led by professor of microbiology Peter Timms.

    The research showed the vaccine reduced the likelihood of koalas developing symptoms of chlamydia during breeding age and decreased mortality from the disease in wild populations by at least 65%.

    The recent approval by Australia’s veterinary medicine regulator means the vaccine can now be used in wildlife hospitals, veterinary clinics and in the field to protect the nation’s most at-risk koalas, Timms said on Wednesday.

    “We knew a single-dose vaccine — with no need for a booster — was the answer to reducing the rapid, devastating spread of this disease, which accounts for as much as half of koala deaths across all wild populations in Australia,” Timms said in a statement.

    “Some individual colonies are edging closer to local extinction every day, particularly in southeast Queensland and New South Wales, where infection rates within populations are often around 50% and in some cases can reach as high as 70%,” Timms added.

    Deborah Tabart, chair of the conservation charity Australian Koala Foundation, said resources being spent on vaccinating koalas should be redirected at saving koala habitat.

    “At the risk of sounding flippant, how can anyone be so delusional as to think that you can vaccinate 100,000 animals? It’s just ridiculous,” Tabart said on Friday.

    Tabart’s foundation estimates there are fewer than 100,000 koalas in the wild. The government-backed National Koala Monitoring Program estimated last year there were between 224,000 and 524,000 koalas.

    “I accept that chlamydia is an issue for koalas, but I also want people to understand that they’re sick because they haven’t got any habitat,” Tabart said.

    The Queensland Conservation Council, an umbrella organization for more than 50 environmental groups across the state, welcomed the vaccine. But the council’s director, Dave Copeman, echoed Tabart’s focus on preserving koala habitat.

    “It’s really good news. Chlamydia is one of the key stresses that has been putting pressure on koala populations,” Copeman said.

    “Koalas were at risk before chlamydia outbreaks, and they will remain at risk even if we manage chlamydia perfectly, because we keep on destroying their habitat,” he added.

    Koalas are listed as endangered species in the states of Queensland and New South Wales and in the Australian Capital Territory, with habitat loss due to wildfires and urban expansion as the major threats. Chlamydia can cause urinary tract infections, infertility, blindness and death.

    Treatment with antibiotics can disrupt an infected koala’s ability to digest eucalyptus leaves — its sole food source — leading to starvation, the university said in a statement.

    The research has been supported by the federal, New South Wales and Queensland governments.

    Federal Environment Minister Murray Watt said his government had contributed to the vaccine’s development through a 76 million Australian dollar ($50 million) Saving Koalas Fund.

    “We know that koalas need help to fight diseases like chlamydia. It’s a widespread threat impacting their reproductive health and causing infertility,” Watt said in a statement.

    Koalas are iconic Australian marsupials, like wombats and kangaroos. They spend most of their time eating and sleeping in eucalyptus trees, and their paws have two opposing thumbs to help them grasp and climb up tree trunks.

    Australia’s wild koala populations have declined steeply in the past two decades.

    Facing compounded threats from disease, habitat loss, climate change and road collisions, koalas could become extinct by 2050, according to a 2020 assessment from the New South Wales government.

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  • Florida’s plan to drop school vaccine rule won’t start for 90 days, won’t cover all diseases

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    Florida’s plan to drop school vaccine mandates likely won’t take effect for 90 days and would include only chickenpox and a few other illnesses unless lawmakers decide to extend it to other diseases, like polio and measles, the health department said Sunday.

    The department responded to a request for details, four days after Florida’s surgeon general, Dr. Joseph Ladapo, said the state would become the first to make vaccinations voluntary and let families decide whether to inoculate their children.

    It’s a retreat from decades of public policy and research that has shown vaccines to be safe and the most effective way to stop the spread of communicable diseases, especially among children. Despite that evidence, U.S. Health Secretary Robert F. Kennedy Jr. has expressed deep skepticism about vaccines.

    Florida’s plan would lift mandates on school vaccines for hepatitis B, chickenpox, Hib influenza and pneumococcal diseases, such as meningitis, the health department said.

    “The Department initiated the rule change on September 3, 2025, and anticipates the rule change will not be effective for approximately 90 days,” the state told The Associated Press in an email. The public school year in Florida started in August.

    All other vaccinations required under Florida law to attend school “remain in place, unless updated through legislation,” including vaccines for measles, polio, diphtheria, pertussis, mumps and tetanus, the department said.

    Lawmakers don’t meet again until January 2026, although committee meetings begin in October.

    Ladapo, appearing Sunday on CNN, repeated his message of free choice for childhood vaccines.

    “If you want them, God bless, you can have as many as you want,” he said. “And if you don’t want them, parents should have the ability and the power to decide what goes into their children’s bodies. It’s that simple.”

    Florida currently has a religious exemption for vaccine requirements. Vaccines have saved at least 154 million lives globally over the past 50 years, the World Health Organization reported in 2024. The majority of those were infants and children.

    Dr. Rana Alissa, chair of the Florida Chapter of the American Academy of Pediatrics, said making vaccines voluntary puts students and school staff at risk.

    This is the worst year for measles in the U.S. in more than three decades, with more than 1,400 cases confirmed nationwide, most of them in Texas, and three deaths.

    Whooping cough has killed at least two babies in Louisiana and a 5-year-old in Washington state since winter, as it too spreads rapidly. There have been more than 19,000 cases as of Aug. 23, nearly 2,000 more than this time last year, according to preliminary CDC data.

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  • Florida surgeon general Ladapo’s vaccine mandates opposition goes against medical mainstream

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    ST. PETERSBURG, Fla. — Dr. Joseph Ladapo, whose credentials include two Harvard University degrees, says that requiring vaccinations for diseases like measles, polio and chickenpox amounts to government-imposed “slavery.” It’s far from the first time Florida’s surgeon general has cut against the medical establishment grain.

    Ladapo, an appointee of Republican Gov. Ron DeSantis, made worldwide headlines this week by announcing Florida would seek to eliminate all mandated vaccinations for schoolchildren and others. He cast the immunization requirements, which date back decades and are considered a major global medical achievement that has saved millions of lives, as improper government intrusion in personal health decisions.

    “Every last one is wrong and drips with disdain and slavery,” Ladapo said at a news conference with DeSantis this week. “Who am I, or anyone else, to tell you what you should put in your body? Who am I to tell you what your child should put in their body? I don’t have that right.”

    So far, a concrete action plan for eliminating immunization mandates in Florida has not emerged, despite multiple requests by The Associated Press. Ladapo acknowledged some proposed changes would require the state Legislature to act. Educators and many health professionals are aghast.

    “Removing policies that keep our children healthy creates unnecessary confusion and fear,” said Dr. Rana Alissa, president of the Florida Chapter of the American Academy of Pediatrics. “Schools are tight-knit networks of children, educators, and families, making it easy for contagious diseases to spread.”

    Ladapo, 46, emigrated from Nigeria to the U.S. at age five with his parents. He earned a degree in chemistry from Wake Forest University and then attended Harvard, where he got his medical degree and also a doctorate in health policy.

    This is a well-trodden path for medical expertise. Ladapo was affiliated after Harvard with New York University and later UCLA, where his op-eds against the pandemic response were noticed by DeSantis, who tapped him as Florida surgeon general in 2021. Ladapo also got a professor position at the University of Florida medical school in the deal.

    Like the governor, Ladapo raised questions about COVID-19 policies that forced people to wear masks and move education online, keep their distance from others and show proof of COVID vaccinations to attend public events, go to a restaurant or take a cruise. Ladapo also misrepresented studies to raise doubts about the mRNA vaccine, the studies’ authors said.

    In a 2024 guidance statement, Ladapo’s Department of Health warned against using the COVID vaccine at all, contending that “the federal government has failed to provide sufficient data to support the safety and efficacy of COVID-19 boosters, or acknowledge previously demonstrated safety concerns associated with COVID-19 vaccines and boosters.” Those purported risks include respiratory tract infections, greater chance of autoimmune disease and cardiovascular problems.

    Almost every major medical or public health organization disputed those assertions, including the Food and Drug Administration: “The challenge we continue to face is the ongoing proliferation of misinformation and disinformation about these vaccines which results in vaccine hesitancy that lowers vaccine uptake,” said the FDA statement, adding that the agency “respectfully disagrees with the Florida Surgeon General’s opinion.”

    In his public comments, Ladapo makes clear he does not follow the guidance of government health experts who, in his view, don’t look at the full picture of how to tackle disease and improve public health. His agency did not respond to an Associated Press request for an interview.

    “It’s just this sea of insanity,” he said this week. “People are going to have to choose a side. People have a right to make their own decisions, informed decisions.”

    Ladapo’s focus on what he and DeSantis call “medical freedom” also fuels his skepticism about other long-established health policies, such as the FDA’s warning against consuming unpasteurized milk that can contain salmonella and other deadly bacteria, or the addition of fluoride in drinking water to promote healthy teeth.

    “At what point are you free to make your own decisions?” DeSantis said this week. “We’ve done a lot over the years to really be on the right side of fighting against the hysteria.”

    Ladapo has many critics in the public health realm and, increasingly, among politicians seeking to tie his unorthodox policies to DeSantis and other Republicans. U.S. Rep. Frederica Wilson, a Democrat from South Florida, wants Ladapo ousted.

    “Are we losing our minds? This is getting ridiculous and pathetic. Are we trying to kill millions of innocent children? Childhood vaccines save lives,” Wilson posted on social media this week. “Governor DeSantis must either remove Joseph Ladapo as Surgeon General or have him resign.”

    There’s no indication that will happen. Ladapo appears to have full support from DeSantis and many conservatives cheer his willingness to buck the medical establishment, including what some see as the untoward influence of pharmaceutical companies.

    “There are many brave people out there — moms & dads, doctors, scientists, and others — who have shown admirable courage in the fight for medical freedom,” Ladapo posted recently on the X social media platform. “Let’s continue. Much more work to be done.”

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  • Fla. to eliminate school vaccine mandates

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    As the administration of Gov. Ron DeSantis prepares to make Florida the first state to remove school vaccine mandates, deep concern is spreading among doctors, parents and public health workers for the safety of children and others who might be vulnerable in a disease outbreak.


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    Copyright 2025 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission.

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    By JEFF MARTIN, MIKE SCHNEIDER and DANIEL KOZIN – Associated Press

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  • The US will buy 2 million doses of an HIV prevention drug for low-income countries

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    WASHINGTON — The U.S. is purchasing enough doses of a new twice-a-year HIV prevention shot to share with up to 2 million people in poor countries by 2028, the State Department announced Thursday.

    Gilead Sciences had already announced it would sell that supply of the protective drug lenacapvir at no profit for use in low- and middle-income countries that are hard-hit by HIV. The question was who would buy and distribute them after the Trump administration slashed foreign aid earlier this year – forcing closures of health clinics and disrupting HIV testing and care in many countries.

    Under Thursday’s move, the U.S. will purchase the doses under the PEPFAR program and work with governments in hard-hit countries on how to distribute them. The priority will be to protect pregnant or breastfeeding women, said Jeremy Lewin, a State department senior official.

    Lewin said the program will be a collaboration with the Global Fund, another international program that funds HIV treatment and prevention efforts but wouldn’t disclose how much the U.S. was investing.

    “We’re hoping, with the Global Fund, to help 2 million people get on the medication over the next three years but could potentially see more,” he said.

    There are more than 30,000 new HIV infections in the U.S. every year and 1.2 million people are living with the virus. Worldwide there are 1.3 million new infections annually and nearly 40 million people living with the virus.

    Many experts say lenacapavir is the most powerful option yet for what’s called PrEP – using preventive medicines to guard against sexually transmitted HIV. Unlike daily pills that people may forget, each lenacapavir shot offers protection for six months. In two groundbreaking studies with people at high risk, it nearly eliminated new infections.

    The drug already has been approved for use in the U.S. and Europe.

    In March, the head of the U.N. AIDS agency urged the Trump administration and Gilead to make the preventive shots available worldwide for millions.

    Gilead has signed agreements with generic drug makers to produce low-cost versions of the shot for poor countries, mostly in Africa, Southeast Asia and the Caribbean. The doses provided at-cost for up to 2 million people in those countries was intended to be a stopgap until the generics are available.

    —-

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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  • There may soon be a new approach to treat hard-to-control high blood pressure

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    Doctors may soon have a new way to treat high blood pressure, even among people for whom medicines haven’t worked well in the past.Baxdrostat, an experimental medicine made by AstraZeneca, showed promise in treating people with uncontrolled or resistant high blood pressure in a recent trial. If the medicine gets approved by regulatory authorities, it will be one of the first new approaches to treating high blood pressure in decades, researchers say.Scientists presented the trial results Saturday at the European Society of Cardiology Congress 2025 in Madrid and simultaneously published them in the New England Journal of Medicine.For the study, researchers enrolled 800 adults who still had high blood pressure after taking two or more medications for at least four weeks. To qualify for the study, patients’ systolic blood pressure had to be between 140 and 170.Blood pressure is measured in millimeters of mercury, which is abbreviated as mm Hg. The measurement has an upper number, or systolic reading, and a lower number, a diastolic reading. Systolic pressure measures the force of blood as it pumps out of the heart into the arteries; diastolic is the pressure created as the heart rests between beats.Normal blood pressure is less than 120/80 mm Hg, and elevated blood pressure is considered to be from 120 to 129/80 mm Hg. At 130/80 mmHg or higher, according to new U.S. guidelines, a person’s medical provider will want them to take a blood pressure medication if lifestyle changes — including eating healthier, reducing salt in the diet and exercising more — don’t work first.The researchers on the new trial placed the participants into three groups. One received 1 milligram of baxdrostat, another got 2 mg, and another got a placebo, which does nothing. Participants took their dose in addition to medicines they were already taking.At 12 weeks, about 4 in 10 patients taking baxdrostat reached healthy blood pressure levels, compared with less than 2 in 10 who got a placebo.Specifically, participants who got 1 or 2 mg of baxdrostat daily saw their systolic blood pressure – the upper number in the reading – fall around 9 to 10 mm Hg more than those taking a placebo. This reduction, studies show, is large enough to cut cardiovascular risk.When blood pressure is high, the force of the blood pushes against the walls of their blood vessels, making the heart less efficient: Both the vessels and the heart must work harder, and it’s more difficult to get blood to essential organs and cells. Without treatment, high blood pressure will eventually damage the arteries, raising the risk of conditions like a heart attack, stroke, coronary disease, vascular dementia and cognitive problems.Heart disease is the No. 1 killer in the world. Lowering blood pressure is the most modifiable way to avoid such a death.Nearly half of all adults in the U.S. have higher than normal blood pressure, and 1 in 10 people have what doctors call resistant hypertension: Despite being on three or more medications, they are not meeting the goal for blood pressure control.When a patient has high blood pressure, doctors may need to try a variety of medications to see what works best.Adding baxdrostat to the list of options could be a big help for patients, according to Dr. Stacey E. Rosen, volunteer president of the American Heart Association, who was not involved with the new research.“What’s interesting about this medication is that they can really be a wonderful partner, so to speak, with some of the more classically recommended anti-hypertensive medications,” said Rosen, who is also a senior vice president of women’s health and executive director of the Katz Institute for Women’s Health of Northwell Health in New York City.Medication options now on the market control blood pressure in a variety of ways. Some, such as vasodilators, relax and widen arteries and veins to allow blood to get through easier and increase flow. Diuretics primarily work by removing excess fluid and salt from the body by increasing urine production. Centrally acting alpha agonists help prevent the nervous system from responding to stress. ACE inhibitors keep the body from producing angiotensin II, a hormone that makes blood vessels constrict. ARBs, or angiotensin II receptor blockers, help reduce the production of aldosterone, a hormone that promotes salt and water retention. Calcium channel blockers can keep calcium away from the cells of the heart and arteries so they don’t have to work as hard.Each can have different side effects, including dizziness, rapid or slower heart rate, exhaustion, upset stomach and swelling in the legs.Baxdrostat’s side effects, the study showed, were mild overall. The most common problem was abnormalities in potassium and sodium levels, but this was rare.Baxdrostat takes a new approach to managing high blood pressure. It focuses on blocking aldosterone, a hormone created by the adrenal glands that helps kidneys regulate salt and maintain the body’s water balance. Some people produce too much aldosterone, leading their body to retain too much water and salt, pushing up blood pressure.“We’ve also known for a while now that most of us eat too much salt and in doing that, it raises blood pressure. But we’re also increasingly recognizing that aldosterone may have a direct impact on causing damage to the blood vessels, to the heart, to the kidneys,” said Dr. Jenifer Brown, one of the lead investigators and co-author of the published study.Brown said she often sees cardiology patients at Brigham and Women’s who may have had a heart event, so she needs to be aggressive in getting their blood pressure under control to prevent another. Some patients may have trouble tolerating other blood pressure medications. For others, the standard medicines just don’t work well. Baxdrostat could be a good complement, she said.“We really have had the same tools as clinicians for many years,” Brown said. “I would be excited to have an option like this.”In an editorial accompanying the publication, Dr. Tomasz Guzik, a cardiovascular scientist at the University of Edinburgh, and Dr. Maciej Tomaszewski, a cardiovascular expert at the University of Manchester, write that next steps should be to figure out which patients would best respond to this new medicine and provide longer-term data. If the medication works long-term, they wrote, it could become a “central piller of therapy for difficult-to-control hypertension.”AstraZeneca said it plans to submit its data to regulatory agencies before the end of 2025.

    Doctors may soon have a new way to treat high blood pressure, even among people for whom medicines haven’t worked well in the past.

    Baxdrostat, an experimental medicine made by AstraZeneca, showed promise in treating people with uncontrolled or resistant high blood pressure in a recent trial. If the medicine gets approved by regulatory authorities, it will be one of the first new approaches to treating high blood pressure in decades, researchers say.

    Scientists presented the trial results Saturday at the European Society of Cardiology Congress 2025 in Madrid and simultaneously published them in the New England Journal of Medicine.

    For the study, researchers enrolled 800 adults who still had high blood pressure after taking two or more medications for at least four weeks. To qualify for the study, patients’ systolic blood pressure had to be between 140 and 170.

    Blood pressure is measured in millimeters of mercury, which is abbreviated as mm Hg. The measurement has an upper number, or systolic reading, and a lower number, a diastolic reading. Systolic pressure measures the force of blood as it pumps out of the heart into the arteries; diastolic is the pressure created as the heart rests between beats.

    Normal blood pressure is less than 120/80 mm Hg, and elevated blood pressure is considered to be from 120 to 129/80 mm Hg. At 130/80 mmHg or higher, according to new U.S. guidelines, a person’s medical provider will want them to take a blood pressure medication if lifestyle changes — including eating healthier, reducing salt in the diet and exercising more — don’t work first.

    The researchers on the new trial placed the participants into three groups. One received 1 milligram of baxdrostat, another got 2 mg, and another got a placebo, which does nothing. Participants took their dose in addition to medicines they were already taking.

    At 12 weeks, about 4 in 10 patients taking baxdrostat reached healthy blood pressure levels, compared with less than 2 in 10 who got a placebo.

    Specifically, participants who got 1 or 2 mg of baxdrostat daily saw their systolic blood pressure – the upper number in the reading – fall around 9 to 10 mm Hg more than those taking a placebo. This reduction, studies show, is large enough to cut cardiovascular risk.

    When blood pressure is high, the force of the blood pushes against the walls of their blood vessels, making the heart less efficient: Both the vessels and the heart must work harder, and it’s more difficult to get blood to essential organs and cells. Without treatment, high blood pressure will eventually damage the arteries, raising the risk of conditions like a heart attack, stroke, coronary disease, vascular dementia and cognitive problems.

    Heart disease is the No. 1 killer in the world. Lowering blood pressure is the most modifiable way to avoid such a death.

    Nearly half of all adults in the U.S. have higher than normal blood pressure, and 1 in 10 people have what doctors call resistant hypertension: Despite being on three or more medications, they are not meeting the goal for blood pressure control.

    When a patient has high blood pressure, doctors may need to try a variety of medications to see what works best.

    Adding baxdrostat to the list of options could be a big help for patients, according to Dr. Stacey E. Rosen, volunteer president of the American Heart Association, who was not involved with the new research.

    “What’s interesting about this medication is that they can really be a wonderful partner, so to speak, with some of the more classically recommended anti-hypertensive medications,” said Rosen, who is also a senior vice president of women’s health and executive director of the Katz Institute for Women’s Health of Northwell Health in New York City.

    Medication options now on the market control blood pressure in a variety of ways. Some, such as vasodilators, relax and widen arteries and veins to allow blood to get through easier and increase flow. Diuretics primarily work by removing excess fluid and salt from the body by increasing urine production. Centrally acting alpha agonists help prevent the nervous system from responding to stress. ACE inhibitors keep the body from producing angiotensin II, a hormone that makes blood vessels constrict. ARBs, or angiotensin II receptor blockers, help reduce the production of aldosterone, a hormone that promotes salt and water retention. Calcium channel blockers can keep calcium away from the cells of the heart and arteries so they don’t have to work as hard.

    Each can have different side effects, including dizziness, rapid or slower heart rate, exhaustion, upset stomach and swelling in the legs.

    Baxdrostat’s side effects, the study showed, were mild overall. The most common problem was abnormalities in potassium and sodium levels, but this was rare.

    Baxdrostat takes a new approach to managing high blood pressure. It focuses on blocking aldosterone, a hormone created by the adrenal glands that helps kidneys regulate salt and maintain the body’s water balance. Some people produce too much aldosterone, leading their body to retain too much water and salt, pushing up blood pressure.

    “We’ve also known for a while now that most of us eat too much salt and in doing that, it raises blood pressure. But we’re also increasingly recognizing that aldosterone may have a direct impact on causing damage to the blood vessels, to the heart, to the kidneys,” said Dr. Jenifer Brown, one of the lead investigators and co-author of the published study.

    Brown said she often sees cardiology patients at Brigham and Women’s who may have had a heart event, so she needs to be aggressive in getting their blood pressure under control to prevent another. Some patients may have trouble tolerating other blood pressure medications. For others, the standard medicines just don’t work well. Baxdrostat could be a good complement, she said.

    “We really have had the same tools as clinicians for many years,” Brown said. “I would be excited to have an option like this.”

    In an editorial accompanying the publication, Dr. Tomasz Guzik, a cardiovascular scientist at the University of Edinburgh, and Dr. Maciej Tomaszewski, a cardiovascular expert at the University of Manchester, write that next steps should be to figure out which patients would best respond to this new medicine and provide longer-term data. If the medication works long-term, they wrote, it could become a “central piller of therapy for difficult-to-control hypertension.”

    AstraZeneca said it plans to submit its data to regulatory agencies before the end of 2025.

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  • CDC receives new acting director amid turmoil

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    The turmoil triggered rare bipartisan alarm as Kennedy tries to advance anti-vaccine policies that are contradicted by decades of scientific research.


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    By MIKE STOBBE, AMANDA SEITZ and CHRIS MEGERIAN – Associated Press

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  • Expect health insurance prices to rise next year, brokers and experts say

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    Pricey prescriptions and nagging medical costs are swamping some insurers and employers now. Patients may start paying for it next year.

    Health insurance will grow more expensive in many corners of the market in 2026, and coverage may shrink. That could leave patients paying more for doctor visits and dealing with prescription coverage changes.

    Price increases could be especially stark in individual coverage marketplaces, where insurers also are predicting the federal government will end some support that helps people buy coverage.

    “We’re in a period of uncertainty in every health insurance market right now, which is something we haven’t seen in a very long time,” said Larry Levitt, an executive vice president at the nonprofit KFF, which studies health care.

    In conference calls to discuss recent earnings reports, insurers ticked off a list of rising costs: More people are receiving care. Visits to expensive emergency rooms are rising, as are claims for mental health treatments.

    Insurers also say more healthy customers are dropping coverage in the individual market. That leaves a higher concentration of sicker patients who generate claims.

    Enrollment in the Affordable Care Act’s insurance marketplaces swelled the past few years. But a crackdown on fraud and a tightening of eligibility verifications that were loosened during the COVID-19 pandemic makes it harder for some to stay covered, Jefferies analyst David Windley noted.

    People who use little care “are disappearing,” he said.

    Prescription drugs pose another challenge, especially popular and expensive diabetes and obesity treatments sometimes called GLP-1 drugs. Those include Ozempic, Mounjaro, Wegovy and Zepbound.

    “Pharmacy just gives me a headache, no pun intended,” said Vinnie Daboul, Boston-based managing director of the employee benefits consultant RT Consulting.

    New gene therapies that can come with a one-time cost of more than $2 million also are having an impact, insurance brokers say. Those drugs, which target rare diseases, and some newer cancer treatments are part of the reason Sun Life Financial covered 47 claims last year that cost over $3 million.

    The financial services company covers high-cost claims for employers that pay their own medical bills. Sun Life probably had no claims that expensive a decade ago and maybe “a handful at best” five years ago, said Jen Collier, president of health and risk solutions.

    Some of these drugs are rarely used, but they cause overall costs to rise. That raises insurance premiums.

    “It’s adding to medical (cost growth) in a way that we haven’t seen in the past,” Collier said.

    Price hikes will be most apparent on the Affordable Care Act’s individual coverage marketplaces. Insurers there are raising premiums around 20% in 2026, according to KFF, which has been analyzing state regulatory filings.

    But the actual hike consumers see may be much bigger. Enhanced tax credits that help people buy coverage could expire at the end of the year, unless Congress renews them.

    If those go away, customer coverage costs could soar 75% or more, according to KFF.

    Business owner Shirley Modlin worries about marketplace price hikes. She can’t afford to provide coverage for the roughly 20 employees at 3D Design and Manufacturing in Powhatan, Virginia, so she reimburses them $350 a month for coverage they buy.

    Modlin knows her reimbursement only covers a slice of what her workers pay. She worries another price hike might push some to look for work at a bigger company that offers benefits.

    “My employee may not want to go to work for a large corporation, but when they consider how they have to pay their bills, sometimes they have to make sacrifices,” she said.

    Costs also have been growing in the bigger market for employer-sponsored coverage, the benefits consultant Mercer says. Employees may not feel that as much because companies generally pay most of the premium.

    But they may notice coverage changes.

    About half the large employers Mercer surveyed earlier this year said they are likely or very likely to shift more costs to their employees. That may mean higher deductibles or that people have to pay more before they reach the out-of-pocket maximum on their coverage.

    For prescriptions, patients may see caps on those expensive obesity treatments or limits on who can take them.

    Some plans also may start using separate deductibles for their pharmaceutical and medical benefits or having patients pay more for their prescriptions, Daboul said.

    Coverage changes could vary around the country, noted Emily Bremer, president of a St. Louis-based independent insurance agency, The Bremer Group.

    Employers aren’t eager to cut benefits, she said, so people may not see dramatic prescription coverage changes next year. But that may not last.

    “If something doesn’t give with pharmacy costs, it’s going to be coming sooner than we’d like to think,” Bremer said.

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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  • Learn about the 5 people charged in connection with Matthew Perry’s death

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    LOS ANGELES — One year ago, federal authorities announced that five people had been charged in connection with the ketamine overdose death of Matthew Perry.

    All five have now agreed to plead guilty, including the personal assistant of the “Friends” star, an old acquaintance and two doctors.

    On Monday, Jasveen Sangha, who prosecutors say was a dealer known as the “Ketamine Queen,” became the fifth and final defendant to reach a deal and avoid trial.

    Here is a look at each of the defendants.

    Sangha admitted in her plea agreement that she sold Perry the lethal dose of ketamine in the days before his death on Oct. 23, 2023.

    A 42-year-old who was born in Britain, raised in the United States and has dual citizenship, Sangha’s social media accounts before her indictment last year showed a jet-setting lifestyle, with photos of herself in posh spaces alongside rich-and-famous faces in Spain, Japan and Dubai along with her dual homes of London and Los Angeles.

    Prosecutors say that lifestyle was funded by a drug business she ran for at least five years from her apartment in LA’s San Fernando Valley.

    They say she presented herself as “a celebrity drug dealer with high quality goods” and missed no opportunity to promote the idea that she was known to customers and others as the “Ketamine Queen.” Her lawyers have derided the title as a “media-friendly” moniker.

    Sangha went to high school in Calabasas, California — perhaps best known as home to the Kardashians — and went to college at the University of California, Irvine, graduating in 2005 and going on to work at Merrill Lynch. She later got an MBA from the Hult International Business School in London.

    She was connected to Perry through his acquaintance and her co-defendant, Erik Fleming.

    In a raid of her apartment in March 2024, authorities said they found large amounts of cocaine, methamphetamine and ketamine. She was arrested and released on bond.

    In August 2024, she was indicted again with charges that tied her to Perry’s death, and has been held without bail ever since.

    CHARGES: Three counts of distribution of ketamine, one count of distribution of ketamine resulting in death or serious bodily injury and one count of maintaining a drug-involved premises.

    SENTENCING: A judge will set her sentencing in the coming months after she appears in court to officially change her plea. She could get up to 45 years in prison.

    WHAT THEY SAID: Sangha’s lawyer Mark Geragos says ”She’s taking responsibility for her actions.”

    Iwamasa, Perry’s live-in personal assistant, was intimately involved in the actor’s illegal ketamine use, acting as his drug messenger and personally giving injections, according to his plea agreement. It was the 60-year-old Iwamasa who found Perry dead in the hot tub of his Pacific Palisades home on a day when he’d given him several injections.

    He would become the first to reach a deal with prosecutors as they sought to use him as an essential witness against other defendants.

    Iwamasa said he worked with co-defendants to get ketamine on Perry’s behalf, including Dr. Salvador Plasencia, who taught him how to give Perry the injections.

    “Found the sweet spot but trying different places led to running out,” Iwamasa told Plasencia in one text message.

    Iwamasa said in his plea deal that he injected Perry six to eight times per day in the last few days of his life.

    CHARGE: One count of conspiracy to distribute ketamine causing death.

    SENTENCING: He’s scheduled to be sentenced November 19 and could get up to 15 years in prison.

    WHAT THEY SAID: Iwamasa’s attorneys have not responded to requests for comment.

    “I wonder how much this moron will pay?”

    That was a text message Plasencia sent to a fellow doctor when he learned Perry wanted to be illegally provided with ketamine, according to a plea agreement where the doctor admitted to selling 20 vials of the drug to the actor in the weeks before his death.

    Plasencia, a 43-year-old Los Angeles-area doctor known to patients as “Dr. P,” was one of the two main targets of the prosecution and had been headed for a joint trial with Sangha when he reached the plea agreement in June.

    According to court records, Perry was connected to Plasencia through another patient. Perry had been getting ketamine legally from his regular doctor as treatment for depression, an off-label but increasingly common use of the surgical anesthetic. But the actor wanted more.

    Plasencia admitted to personally injecting Perry with some of the initial vials he provided, and left more for Iwamasa to inject, despite the fact that Perry froze up and his blood pressure spiked, after one dose.

    Plasencia graduated from UCLA’s medical school in 2010 and had not been subject to any medical disciplinary actions before the Perry case.

    He has been free on bond since his indictment. His lawyers said he is caregiver for a toddler child.

    Plasencia even got to keep practicing medicine after his indictment, but had to inform patients of the charges against him and couldn’t prescribe dangerous drugs. He now intends to voluntarily surrender his license to practice, according to his lawyers.

    CHARGES: Four counts of distribution of ketamine.

    SENTENCING: He’s scheduled to be sentenced Dec. 3 and could get up to 40 years in prison.

    WHAT THEY SAID: His lawyers say he’s “profoundly remorseful for the treatment decisions he made while providing ketamine to Matthew Perry.”

    Fleming, 55, was an acquaintance of Perry’s who learned through a mutual friend that the actor was seeking ketamine, according to his plea agreement.

    He told Iwamasa in text messages that he had a source known as the “Ketamine Queen” whose product was “amazing,” saying she only deals with “high end and celebs.”

    In all, prosecutors say, Fleming delivered 50 vials of Sangha’s ketamine for Perry’s use, including 25 sold for a total of $6,000 to the actor four days before his death.

    CHARGE: One count of distribution of ketamine resulting in death.

    SENTENCING: He is scheduled to be sentenced November 12 and could get up to 25 years in prison.

    WHAT THEY SAID: Fleming’s lawyers have declined comment.

    Chavez, a San Diego doctor who ran a ketamine clinic, was the source of the doses that Plasencia sold to Perry, according to their plea agreements.

    Chavez admitted to obtaining the ketamine from a wholesale distributor on false pretenses.

    Chavez, 55, graduated from UCLA’s medical school in 2004. He has surrendered his medical license.

    CHARGE: One count of conspiracy to distribute ketamine.

    SENTENCING: He is scheduled to become the first defendant sentenced, on Sept. 17. He could get 10 years in prison.

    WHAT THEY SAID: His lawyer says he’s “incredibly remorseful,” has accepted responsibility and has been “trying to do everything in his power to right the wrong.”

    ___

    Former Associated Press journalist Kaitlyn Huamani contributed reporting.

    ___

    A version of this story first ran on Aug. 15, 2024.

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  • FACT FOCUS: RFK Jr.’s reasons for cutting mRNA vaccine not supported by evidence

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    Although mRNA vaccines saved millions of lives during the COVID-19 pandemic, U.S. Health Secretary Robert F. Kennedy Jr. incorrectly argued they are ineffective to justify the Department of Health and Human Service’s recent decision to cancel $500 million in government-funded research projects to develop new vaccines using the technology.

    The longtime vaccine critic said in an X video posted Tuesday evening that mRNA vaccines do not adequately prevent upper respiratory infections such as COVID-19 and the flu, advocating instead for the development vaccines that use other processes.

    COVID-19 is the only virus for which real-world data on mRNA vaccine effectiveness is currently available, as mRNA vaccines for other diseases, including the flu, are still under development. The two scientists whose discoveries enabled the creation of mRNA vaccines against COVID-19 won a Nobel Prize in 2023 for their work.

    Kennedy’s claim ignores how mRNA vaccines work, according to experts. They prevent against severe infection and death, but cannot completely prevent an infection from occurring in the first place. Plus, years of research supports the effectiveness of COVID-19 vaccines that use mRNA technology.

    Here’s a closer look at the facts.

    KENNEDY: “As the pandemic showed us, mRNA vaccines don’t perform well against viruses that infect the upper respiratory tract.”

    THE FACTS: His claim is contradicted by scientific evidence. Countless studies show that vaccinated individuals fare far better against COVID-19 infections than those who are unvaccinated, while others have estimated that COVID-19 vaccines prevented millions of deaths during the global pandemic. The mRNA vaccines do not prevent respiratory diseases entirely, experts say. Rather, they can prevent more serious illness that leads to complications and death. For example, an mRNA vaccine against COVID-19 may prevent an infection in the upper respiratory tract that feels like a bad cold from spreading to the lower respiratory tract, where it could affect one’s ability to breathe.

    “A vaccine cannot block a respiratory infection,” said Dr. Jake Scott, an infectious diseases physician and clinical associate professor at Stanford University School of Medicine. “That’s never been the standard for a respiratory virus vaccine. And it’s never been the expectation, and it’s never been that realistic.” He called Kennedy’s claim “misguided.”

    Jeff Coller, a professor of RNA biology and therapeutics at Johns Hopkins University, had a similar outlook.

    “Vaccinations don’t have to be neutralizing, meaning that you’re not going to get COVID,” he said. “But the important part of a vaccination is that they reduce hospitalization and death. And a reduction in hospitalization and death is proof of an effective vaccine.”

    HHS officials did not immediately respond to a request for comment.

    Vaccines have traditionally required growing viruses or pieces of viruses called proteins and then purifying them. Then a small dose of the vaccine is injected to train the body how to recognize when a real infection hits so it’s ready to fight back. But this method takes a long time. The mRNA technology speeds up the process and allows existing vaccines to be updated more quickly.

    The “m” in mRNA stands for messenger because the vaccine carries instructions for our bodies to make proteins. Scientists figured out how to harness that natural process for vaccines by making mRNA in a lab. They take a snippet of the genetic code that carries instructions for making the protein they want the vaccine to target. Injecting that snippet instructs the body to become its own mini-vaccine factory, making enough copies of the protein for the immune system to recognize and react.

    Scott explained that mRNA vaccines are not a “magic force field” that the immune system can use to block an infection, as it can’t detect whether a virus is nearby. It can only respond to a virus that has already entered the body. In the case of COVID-19, this means that the virus could cause an upper respiratory tract infection — a cold, essentially — but would be significantly less likely to cause more severe consequences elsewhere.

    Myriad studies on the effectiveness of COVID-19 vaccines have been published since they first became available in late 2020. Although protection does wane over time, they provide the strongest barrier against severe infection and death.

    For example, a 2024 study by the World Health Organization found COVID-19 vaccines reduced deaths in the WHO’s European region by at least 57%, saving more than 1.4 million lives since their introduction in December 2020.

    A 2022 study published in the journal Lancet Infectious Diseases found that nearly 20 million lives were saved by COVID-19 vaccines during their first year. Researchers used data from 185 countries to estimate that vaccines prevented 4.2 million COVID-19 deaths in India, 1.9 million in the United States, 1 million in Brazil, 631,000 in France and 507,000 in the United Kingdom. The main finding — that 19.8 million COVID-19 deaths were prevented — is based on estimates of how many more deaths than usual occurred during the time period. Using only reported COVID-19 deaths, the same model yielded 14.4 million deaths averted by vaccines.

    Another 2022 study, published in The New England Journal of Medicine, reported that two mRNA vaccines were more than 90% effective against COVID-19.

    Operation Warp Speed, the federal effort to facilitate the development and distribution of a COVID-19 vaccine, began under the first Trump administration.

    “What I don’t understand is why is President Trump is allowing RFK Jr. to undermine his legacy that led to a medical intervention that literally saved millions of lives?” Coller said. “Why is Trump allowing RFK to undermine U.S. leadership in biomedical research and drug development?”

    ___

    Find AP Fact Checks here: https://apnews.com/APFactCheck.

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  • A promising schizophrenia drug showed mixed results. What does that mean for patients?

    A promising schizophrenia drug showed mixed results. What does that mean for patients?

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    Some people who took a new schizophrenia drug for a year improved with only a few side effects, but many dropped out of the research, the company announced Thursday.

    The results underscore the difficulties in treating schizophrenia, a severe mental illness that can cause people to hear voices, feel paranoid and withdraw from others. High dropout rates are typical in schizophrenia drug studies.

    Finding a drug that works can be a long ordeal punctuated by crises and hospitalizations. Side effects of existing medications — weight gain, tremors, restlessness — cause some people to stop taking medicine and relapse.

    There’s been great hope among doctors for Cobenfy, which was approved in September, because it acts in the brain differently than other schizophrenia drugs. Instead of blocking dopamine receptors, Cobenfy’s main ingredient, xanomeline, works on a different receptor that indirectly blocks dopamine release.

    Cobenfy also contains trospium, which blocks some of the side effects. The most common are nausea, vomiting and indigestion. In contrast to the weight gain seen with other schizophrenia drugs, people lost a few pounds while taking Cobenfy, made by Bristol Myers Squibb.

    Dr. John Krystal of Yale University has led research on other schizophrenia drugs but was not involved in the new studies. He noted that just 10% to 20% of participants in the new studies dropped out because of side effects.

    “That is pretty good,” he said, noting that fewer or milder side effects could mean people will stay in treatment longer. That could mean fewer problems associated with untreated mental illness: substance use, homelessness and unemployment.

    So why did some patients stick with treatment while others dropped out? Krystal said it will be important to understand more about that as doctors start prescribing the drug.

    The Food and Drug Administration approved Cobenfy on the strength of two encouraging company-sponsored five-week trials and other safety data. The latest results announced Thursday at the Psych Congress meeting in Boston come from two longer studies, providing a fuller picture.

    In one study, focused on severely ill patients, 78% dropped out, leaving only 35 people for the final analysis. In the other, focused on more stable people, 51% left the study, leaving 283 who took the drug for a year.

    “It’s not any higher or any lower than what we typically see” in schizophrenia studies, said Dr. Greg Mattingly of Washington University School of Medicine in St. Louis. Mattingly is a consultant for Bristol Myers Squibb and a researcher on one of the studies.

    In the more severely ill group, 69% of people had a meaningful improvement in their symptoms at the end of the year. In the other group, 30% saw a meaningful benefit.

    Results of interviews with a sample of study participants conducted by an independent research team and shared by Bristol Myers Squibb showed the likelihood of continuing treatment. After six months, 36 said they would continue taking Cobenfy after the trial if given the option; 10 said they would not. Some participants said the drug reduced the voices while others said it didn’t work for them.

    The estimated yearly cost for Cobenfy is $22,500 compared to $540 for a generic antipsychotic. Krystal and others worry that insurers will require people to try cheaper drugs first before covering Cobenfy. Most patients’ out-of-pocket costs will be much lower, depending on insurance and other factors.

    One cheaper generic called clozapine is widely considered one of the best treatments for schizophrenia, Krystal said. It is underused in the U.S. compared to some other countries because of a cumbersome blood testing program.

    The FDA started the blood tests to watch for the risk of severe neutropenia, a rare side effect which can be fatal. But doctors and families have told the FDA that patients have relapsed when their clozapine was withheld or delayed because of the testing requirements.

    Sally Littlefield, 29, of Alameda, California, said what works for her is a monthly injection of a long-acting antipsychotic medication. Littlefield, who has schizophrenia and bipolar disorder, wants to learn more about the experiences of people who’ve taken Cobenfy and not just from players with a financial stake.

    Mindy Greiling of Roseville, Minnesota, wants to see data on how Cobenfy compares to clozapine, which works for her 47-year-old son, Jim. Weight gain was a problem for him, but since taking diabetes medication, he’s back to his normal weight, Greiling said.

    Cobenfy “is getting a lot of ballyhoo, as any new drug does,” Greiling said. “It’s just a nonstarter for me unless it turns out that it’s better than clozapine.”

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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  • Nobel Prize in medicine honors two Americans for discovery of microRNA

    Nobel Prize in medicine honors two Americans for discovery of microRNA

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    STOCKHOLM — The Nobel Prize in medicine was awarded Monday to Americans Victor Ambros and Gary Ruvkun for their discovery of microRNA, a fundamental principle governing how gene activity is regulated.

    The Nobel Assembly said that their discovery is “proving to be fundamentally important for how organisms develop and function.”

    Ambros performed the research that led to his prize at Harvard University. He is currently a professor of natural science at the University of Massachusetts Medical School. Ruvkun’s research was performed at Massachusetts General Hospital and the Harvard Medical School, where he’s a professor of genetics, said Thomas Perlmann, Secretary-General of the Nobel Committee.

    Perlmann said he spoke to Ruvkun by phone shortly before the announcement.

    “It took a long time before he came to the phone and sounded very tired, but he quite rapidly, was quite excited and happy, when he understood what, it was all about,” Perlmann said.

    Last year, the Nobel Prize in Physiology or Medicine went to Hungarian-American Katalin Karikó and American Drew Weissman for discoveries that enabled the creation of mRNA vaccines against COVID-19 that were critical in slowing the pandemic.

    The prize carries a cash award of 11 million Swedish kronor ($1 million) from a bequest left by the prize’s creator, Swedish inventor Alfred Nobel.

    The announcement launched this year’s Nobel prizes award season.

    Nobel announcements continue with the physics prize on Tuesday, chemistry on Wednesday and literature on Thursday. The Nobel Peace Prize will be announced Friday and the Nobel Memorial Prize in Economic Sciences on Oct. 14.

    The laureates are invited to receive their awards at ceremonies on Dec. 10, the anniversary of Nobel’s death.

    ___

    Corder reported from The Hague, Netherlands.

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  • Doctor charged in connection with Matthew Perry’s death is expected to plead guilty

    Doctor charged in connection with Matthew Perry’s death is expected to plead guilty

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    LOS ANGELES — One of two doctors charged in the investigation of the death of Matthew Perry is expected to plead guilty Wednesday in a federal court in Los Angeles to conspiring to distribute the surgical anesthetic ketamine.

    Dr. Mark Chavez, 54, of San Diego, signed a plea agreement with prosecutors in August and would be the third person to plead guilty in the aftermath of the “Friends” star’s fatal overdose last year.

    Prosecutors offered lesser charges to Chavez and two others in exchange for their cooperation as they go after two targets they deem more responsible for the overdose death: another doctor and an alleged dealer that they say was known as “ketamine queen” of Los Angeles.

    Chavez is free on bond after turning over his passport and surrendering his medical license, among other conditions.

    His lawyer Matthew Binninger said after Chavez’s first court appearance on Aug. 30 that he is “incredibly remorseful” and is “trying to do everything in his power to right the wrong that happened here.”

    Also working with federal prosecutors are Perry’s assistant, who admitted to helping him obtain and inject ketamine, and a Perry acquaintance, who admitted to acting as a drug messenger and middleman.

    The three are helping prosecutors in their prosecution of Dr. Salvador Plasencia, charged with illegally selling ketamine to Perry in the month before his death, and Jasveen Sangha, a woman who authorities say sold the actor the lethal dose of ketamine. Both have pleaded not guilty and are awaiting trial.

    Chavez admitted in his plea agreement that he obtained ketamine from his former clinic and from a wholesale distributor where he submitted a fraudulent prescription.

    After a guilty plea, he could get up to 10 years in prison when he is sentenced.

    Perry was found dead by his assistant on Oct. 28. The medical examiner ruled ketamine was the primary cause of death. The actor had been using the drug through his regular doctor in a legal but off-label treatment for depression that has become increasingly common.

    Perry began seeking more ketamine than his doctor would give him. About a month before the actor’s death, he found Plasencia, who in turn asked Chavez to obtain the drug for him.

    “I wonder how much this moron will pay,” Plasencia texted Chavez. The two met up the same day in Costa Mesa, halfway between Los Angeles and San Diego, and exchanged at least four vials of ketamine.

    After selling the drugs to Perry for $4,500, Plasencia asked Chavez if he could keep supplying them so they could become Perry’s “go-to.”

    Perry struggled with addiction for years, dating back to his time on “Friends,” when he became one of the biggest stars of his generation as Chandler Bing. He starred alongside Jennifer Aniston, Courteney Cox, Lisa Kudrow, Matt LeBlanc and David Schwimmer for 10 seasons from 1994 to 2004 on NBC’s megahit sitcom.

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  • Why is Congo struggling to contain mpox?

    Why is Congo struggling to contain mpox?

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    KAVUMU, Congo — Health authorities have struggled to contain outbreaks of mpox in Congo, a huge central African country where a myriad of existing problems makes stemming the spread particularly hard.

    Last month, the World Health Organization declared the outbreaks in Congo and about a dozen other African countries a global health emergency. And in Congo, scientists have identified a new strain of mpox that may spread more easily. It has reached areas where conflict and the displacement of a large number of people have already put health services under pressure.

    Overall, Congo has more than 21,000 of the 25,093 confirmed and suspected mpox cases in Africa this year, according to WHO’s most recent count.

    Yes, Congo is one of the African countries where mpox has been endemic for decades.

    Mpox, once known as monkeypox, comes from the same family of viruses as smallpox but causes milder symptoms such as fever. People with more serious cases can develop skin lesions. More than 720 people in Africa have died in the latest outbreaks, mostly in Congo.

    Mpox is a zoonotic disease, meaning it can spread to humans from infected animals. In the global mpox outbreak of 2022, the virus spread between people primarily through sex and close physical contact.

    In September 2023, mpox spread to Congo’s eastern province of South Kivu; it had previously been seen in the center and far west. Scientists then identified a new form of mpox in South Kivu that may be more infectious.

    The WHO said that from the outbreak in South Kivu, the virus spread among people elsewhere in the country, arriving in neighboring province North Kivu. Those two provinces — some 2,000 kilometers (1,240 miles) from the capital, Kinshasa — face escalating violence, a humanitarian crisis and other issues.

    More than 120 armed groups have been fighting each other and the Congolese army for years in the eastern part of the country over the control of minerals. That has forced millions of people fleeing violence into refugee camps or nearby towns.

    That means mpox is hitting already-stretched health facilities. Dr. Musole Mulambamunva Robert, medical director of the Kavumu hospital in eastern Congo, said it is “truly a challenge” — sometimes treating as many as four times the facility’s capacity for patients.

    With more than 6 million displaced people in the east, authorities and aid agencies were already struggling to provide food and healthcare, while fighting other diseases such as cholera. Many people have no access to soap, clean water or other basics.

    Some eastern Congo communities are out of reach of health clinics — roads are unreliable, and hourslong risky boat trips are sometimes the only means of transport, said Mercy Muthee Lake of the International Federation of Red Cross and Red Crescent.

    People can be more susceptible to severe mpox cases because of malnutrition and undiagnosed HIV, she said.

    She also said health workers in eastern Congo have requested more mpox training as medications to treat fever and ease pain run out.

    Health authorities “are up against it because it’s such a complex area,” said Chris Beyrer, of Duke University’s Global Health Institute.

    Africa has no capacity to produce mpox vaccines. Around 250,000 doses have arrived in Congo from the European Union and the United States, and more are expected. Congolese authorities say they need around 3 million vaccines. It will likely be weeks before any vaccines reach people in eastern Congo.

    For now, the vaccine is approved only for adults. There’s limited evidence of how it works in children.

    Vaccines are desperately needed, but they’re just “an additional tool,” said Emmanuel Lampaert, the Congo representative for Doctors Without Borders. The key, Lampaert said, is still identifying cases, isolating patients, and executing grassroots health and education campaigns.

    Local conditions make that trying — Lampaert noted it’s almost impossible to isolate cases among poor, displaced people.

    “Families with six to eight children are living in a hut, which is maybe the space of the bed we are sleeping in,” he said. “So, this is the reality.”

    Unlike the millions of dollars that poured into Congo for Ebola and COVID aid, the response to mpox has been sluggish, many critics say.

    Health experts say the sharp contrast is due to a lack of both funds and international interest.

    “Ebola is the most dangerous virus in the world, and COVID wiped out the world economy,” said professor Ali Bulabula, who works on infectious diseases in the medical department at Congo’s University of Kindu. “While mpox is a public health emergency of international concern, there is a lack of in-depth research and interest in the virus, as it’s still seen as a tropical disease, localized to Africa with no major impact on Western economies.”

    ___

    Asadu reported from Abuja, Nigeria, and Imray reported from Cape Town, South Africa. AP reporter Sam Mednick contributed from Kamituga, Congo.

    ___

    For more news on Africa and development: https://apnews.com/hub/africa-pulse

    ___

    The Associated Press receives financial support for global health and development coverage in Africa from the Gates Foundation. The AP is solely responsible for all content. Find AP’s standards for working with philanthropies, a list of supporters and funded coverage areas at AP.org.

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  • Kidney disease medication found to reduce risk of cardiovascular death in certain heart failure patients

    Kidney disease medication found to reduce risk of cardiovascular death in certain heart failure patients

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    CHRISTOPHER SALAS WCVB NEWSCENTER FIVE. ALL RIGHT. THERE IS A NEW STUDY THAT SHOWS THE MAIN INGREDIENT IN OZEMPIC AND WEGOVY, WHICH ALREADY HELP WITH DIABETES AND WEIGHT LOSS. MAY DRACUT RADICALLY CUT THE RISKS FROM CHRONIC KIDNEY DISEASE. WE WERE JUST TALKING ABOUT THIS HERE. TO TALK MORE ABOUT IT IS DOCTOR TODD ELLERIN. OF COURSE, WITH SOUTH SHORE HEALTH. IT’S SO INTERESTING BECAUSE IN SOME CASES IT’S THESE THESE DRUGS GET A BAD RAP BECAUSE PEOPLE GET SICK AND BUT YOU’RE A DOCTOR, YOU SEE THEM IN A TOTALLY DIFFERENT LIGHT. THIS RESEARCH SHOWS THAT. AND I’M GOING TO TRY TO GET THE RIGHT NAME. RIGHT. IS IT SEMAGLUTIDE? THAT’S EXACTLY OKAY. IT’S THE MAIN INGREDIENT IN THOSE DRUGS. AND IT HAD A 24% LOWER RISK OF MAJOR KIDNEY DISEASE ISSUES. UM, PEOPLE WHO ARE IN DIALYSIS, WHO ARE ON DIALYSIS OR THEY NEED A KIDNEY TRANSPLANT. THAT’S SIGNIFICANT. THIS IS REALLY SIGNIFICANT. MARIA WHAT WE’RE SEEING IS NOT JUST WE’VE ALREADY SEEN THESE DRUGS, SEMAGLUTIDE DECREASE, THIS DIABETES DECREASE WEIGHT LOSS. YOU KNOW, SIGNIFICANT WEIGHT LOSS ALSO HEART FAILURE DEATH FROM THIS. BUT IN THIS STUDY, LARGE STUDY 3500 PATIENTS INTERNATIONAL RANDOMIZED HALF WERE GIVEN AN INJECTION OF OZEMPIC ONE MILLIGRAM ONCE A WEEK. THE OTHER PLACEBO. AND WHAT THEY SHOWED WAS THERE WAS A SIGNIFICANT DECREASE IN NOT ONLY KIDNEY DISEASE AND KIDNEY FAILURE, BUT ALSO CARDIOVASCULAR DISEASE AND DEATH. DEATH FROM ALL CAUSES. IT’S A BIG DEAL, BUT YOU NEED TO HAVE A PRESCRIPTION FOR THIS. SO TRUE. AND YOU NEED TO HAVE THESE ISSUES TO GET THAT PRESCRIPTION CORRECT. IN THIS STUDY. THESE WERE ALL PATIENTS WITH TYPE TWO DIABETES OKAY. AND CHRONIC KIDNEY DISEASE. SO YOU HAD TO HAVE BOTH FOR THIS STUDY. ALL RIGHT. SO THIS IS THE LATEST STUDY TO TO TALK ABOUT THIS ADDED BENEFIT FROM THE DRUGS. IT’S NEW. THEY’RE NEW. YOU HAVE TO ADMIT THAT THEY’RE NEW. SO HOW DO WE KNOW ABOUT LONG TERM EFFECTS. LOOK I THINK THEY’RE NEW BUT THEY’RE STILL WE’VE SEEN THIS OVER YEARS AND WE’VE SEEN MULTIPLE DRUGS FROM DIFFERENT CLASSES. AND AND WHAT WE’RE SEEING IS GI SIDE EFFECTS ARE THE MOST COMMON. AND THEN THERE ARE OTHER RARE SIDE EFFECTS. BUT REALLY THE BENEFITS ARE JUST SIGNAL SHIRLEY OUTSTRIPPING THE RISKS. THAT’S SO INTERESTING. IT IS. WE HAVE WE HAVE TO POINT OUT, BY THE WAY, THIS TRIAL WAS FUNDED BY NOVO NORDISK. THAT’S THE COMPANY THAT MAKES OZEMPIC. SO WE ALWAYS HAVE TO PUT THAT IN PERSPECTIVE. SHOULD THAT CHANGE HOW WE LOOK AT THESE RESULTS? I DON’T THINK SO. AND Y YOU HEARD ME SAY BEFORE, IT’S NOT JUST THIS PHARMACEUTICAL COMPANY WITH SEMAGLUTIDE, BUT THERE’S OTHER COMPANIES LIKE ELI LILLY HAS ANOTHER APPETITE. AND WE’RE SEEING THE SAME BENEFITS AGAIN. AND AGAIN. DIFFERENT COMPANIES, NOT JUST IN DIABETICS, BUT IN PATIENTS WHO ARE OBESE. WE’RE SEEING DECREASES IN HEART FAILURE, HEART ATTACKS, STROKES. AND REMEMBER SOMETHING THIS GLP AGONISTS RIGHT. THESE RECEPTORS ARE NOT JUST ON THE HEART AND THE KIDNEY AND THE PANCREAS, BUT WE’RE ALSO SEEING IT IN THE BRAIN. SO YOU CAN IMAGINE STUDIES ARE ALSO GOING TO BE DONE IN ALZHEIMER’S DISEASE. ADDICTION. WE HAVE TO WAIT TO SEE. BUT SO FAR VERY PROMISING. WOW. SO INTERESTING. WE’VE RUN OUT OF TIME. BUT I’D LOVE TO EXPLORE MORE BECAUSE THERE ARE PEOPLE WHO ARE TAKING THIS AND AND THEY’RE IN THE OFF MARKET AND THEY SHOULDN’T BE TAKING IT. THAT’S A DIFFERENT STORY, RIGHT? AND THAT’S A DIFFERENT STORY THAT WE’RE TALKING ABOUT THESE HEALTH BENEFITS WITH A DOCTOR. SO VERY INTERESTING. ENJO

    Kidney disease medication found to reduce risk of cardiovascular death in certain heart failure patients in new study

    A medication that is currently used for chronic kidney disease in patients with type 2 diabetes has been found to reduce the risk of worsening heart failure and cardiovascular death in certain people with heart failure, according to a new study.Video above: Can Ozempic, Wegovy cut chronic kidney disease risk?The medication, finerenone, could be an effective therapy in people with heart failure who have mildly reduced or preserved ejection fraction, suggests the study, published Sunday in the New England Journal of Medicine.”People don’t realize this, but if you’re hospitalized for heart failure, you have a life expectancy that can be worse than most cancers, and so we have been desperately looking for therapies that can lower that risk,” said Dr. Scott Solomon, professor of medicine at Harvard Medical School and the Edward D. Frohlich Distinguished Chair at Brigham and Women’s Hospital, who was a trial principal investigator in the study.”We’ve made enormous strides in the field of heart failure in the last 20 to 25 years, but mostly that’s been in the type of heart failure called heart failure with reduced ejection fraction, when the heart doesn’t pump very well,” Solomon said. But when it comes to heart failure with mildly reduced or preserved ejection fraction, few therapies are available.”That’s the reason that we did this trial,” he said. “There’s still a huge unmet need in this population.”Ejection fraction refers to the percentage of blood the heart pumps out with each beat. When someone has heart failure with mildly reduced or preserved ejection fraction, their heart could be pumping normally, or somewhat normally, but still be showing signs or symptoms of heart failure. More than 6 million people in the United States are living with heart failure, and it’s estimated that nearly half of all patients with heart failure have a mildly reduced or preserved ejection fraction.The new study “highlights the importance of this type of heart failure, which is only growing as our population ages,” Solomon said.Heart failure with mildly reduced or preserved ejection fraction often can be managed with medications called sodium-glucose co-transporter 2 or SGLT2 inhibitors, which help lower blood sugar. But the new study suggests that finerenone “could potentially be a second pillar of therapy in patients with heart failure with mildly reduced or preserved ejection fraction,” Solomon said.Finerenone, sold under the brand names Kerendia and Firialta, was approved in 2021 by the US Food and Drug Administration to reduce the risk of serious complications in certain adults with chronic kidney disease associated with type 2 diabetes.In order for the drug to get FDA approval for use in these people with heart failure, Bayer, the pharmaceutical company behind finerenone, would need to apply to the agency for an expanded indication.The new study, funded by Bayer, included more than 6,000 people 40 and older in 37 countries who had heart failure and mildly reduced or preserved ejection fraction.Between September 2020 and January 2023, the patients were separated into two groups; 3,003 were provided a daily dose of finerenone, and 2,998 were given a placebo.The international team of researchers found that there were 1,024 heart failure events among people in the placebo group, compared with 842 events in the finerenone group.Additionally, 8.7% of the participants in the placebo group died from cardiovascular causes during the course of the study, compared with 8.1% of the finerenone group, the data showed.”The reduction in morbidity and mortality that we see will translate to years of life free of heart failure events in these patients,” said Solomon, who presented the study findings Sunday at the European Society of Cardiology conference in London.Finerenone is a type of mineralocorticoid receptor antagonist, or MRA. These drugs work by blocking the receptor for the hormone aldosterone. Aldosterone makes the kidneys hold on to salt and water, which can raise your blood pressure. When the drug blocks the receptor, the kidneys release excess water and salt from the blood, which can also affect potassium levels, but the drug prevents the loss of potassium. It’s important to keep potassium at certain levels because too much in the blood can damage the heart, and low levels can affect certain functions in the body.The researchers found that people taking finerenone showed a higher risk of hyperkalemia, or having too much potassium in the blood. But very few of them – 0.5% of patients in the finerenone group and 0.2% in the placebo group – were hospitalized for hyperkalemia.”Any drug that works in this way, the mineralocorticoid receptor antagonists, will raise potassium in the blood,” Solomon said. “This is a very well-established and known side effect, but these drugs reduce the risk of low potassium, which also places patients at risk.”Bayer previously released top line results from this study in early August. In that announcement, Dr. Christian Rommel, head of research and development at Bayer’s Pharmaceuticals Division, said the company is “eager to bring finerenone to eligible patients as soon as possible.”A separate paper, published Sunday in The Lancet, reviewed four clinical trials on MRAs in heart failure and found “significant reductions” in heart failure hospitalizations among heart failure patients.The meta-analysis showed that steroidal MRAs reduced the risk of cardiovascular death or heart failure hospitalization in patients with heart failure who had reduced ejection fraction, and nonsteroidal MRAs reduced this risk in people with heart failure who had mildly reduced or preserved ejection fraction. Finerenone, a nonsteroidal MRA, was among the drugs in the trials.If the FDA expands the use of finerenone as a heart failure therapy, cardiologist Dr. Michelle Bloom said, she would think about it as an option for her patients with mildly reduced or preserved ejection fraction.”I would certainly consider using finerenone,” Bloom, heart failure cardiologist and system director of the Cardio-Oncology Program at NYU Langone Health in New York, said in an email.”However, I think the question is what the benefit of finerenone will be over the more traditional MRAs such as spironolactone and eplerenone. This remains to be answered,” she said.Overall, heart failure patients with preserved ejection fraction “have historically been difficult to treat and manage,” Dr. Jayne Morgan, an Atlanta-based cardiologist and vice president for medical affairs at the heart health company Hello Heart, said in an email.The new study “certainly provides support for additive therapy with finerenone. However certainly more data is needed, including independent data not financed by the sponsor,” Morgan said. “Further, we’d like to see more Blacks and minorities enrolled to truly make the data relevant to all sufferers.”In the study, the researchers noted that few Black patients were enrolled.Still, the study findings give “reason for cautious optimism,” Morgan said.

    CNN —

    A medication that is currently used for chronic kidney disease in patients with type 2 diabetes has been found to reduce the risk of worsening heart failure and cardiovascular death in certain people with heart failure, according to a new study.

    Video above: Can Ozempic, Wegovy cut chronic kidney disease risk?

    The medication, finerenone, could be an effective therapy in people with heart failure who have mildly reduced or preserved ejection fraction, suggests the study, published Sunday in the New England Journal of Medicine.

    “People don’t realize this, but if you’re hospitalized for heart failure, you have a life expectancy that can be worse than most cancers, and so we have been desperately looking for therapies that can lower that risk,” said Dr. Scott Solomon, professor of medicine at Harvard Medical School and the Edward D. Frohlich Distinguished Chair at Brigham and Women’s Hospital, who was a trial principal investigator in the study.

    “We’ve made enormous strides in the field of heart failure in the last 20 to 25 years, but mostly that’s been in the type of heart failure called heart failure with reduced ejection fraction, when the heart doesn’t pump very well,” Solomon said. But when it comes to heart failure with mildly reduced or preserved ejection fraction, few therapies are available.

    “That’s the reason that we did this trial,” he said. “There’s still a huge unmet need in this population.”

    Ejection fraction refers to the percentage of blood the heart pumps out with each beat. When someone has heart failure with mildly reduced or preserved ejection fraction, their heart could be pumping normally, or somewhat normally, but still be showing signs or symptoms of heart failure. More than 6 million people in the United States are living with heart failure, and it’s estimated that nearly half of all patients with heart failure have a mildly reduced or preserved ejection fraction.

    The new study “highlights the importance of this type of heart failure, which is only growing as our population ages,” Solomon said.

    Heart failure with mildly reduced or preserved ejection fraction often can be managed with medications called sodium-glucose co-transporter 2 or SGLT2 inhibitors, which help lower blood sugar. But the new study suggests that finerenone “could potentially be a second pillar of therapy in patients with heart failure with mildly reduced or preserved ejection fraction,” Solomon said.

    Finerenone, sold under the brand names Kerendia and Firialta, was approved in 2021 by the US Food and Drug Administration to reduce the risk of serious complications in certain adults with chronic kidney disease associated with type 2 diabetes.

    In order for the drug to get FDA approval for use in these people with heart failure, Bayer, the pharmaceutical company behind finerenone, would need to apply to the agency for an expanded indication.

    The new study, funded by Bayer, included more than 6,000 people 40 and older in 37 countries who had heart failure and mildly reduced or preserved ejection fraction.

    Between September 2020 and January 2023, the patients were separated into two groups; 3,003 were provided a daily dose of finerenone, and 2,998 were given a placebo.

    The international team of researchers found that there were 1,024 heart failure events among people in the placebo group, compared with 842 events in the finerenone group.

    Additionally, 8.7% of the participants in the placebo group died from cardiovascular causes during the course of the study, compared with 8.1% of the finerenone group, the data showed.

    “The reduction in morbidity and mortality that we see will translate to years of life free of heart failure events in these patients,” said Solomon, who presented the study findings Sunday at the European Society of Cardiology conference in London.

    Finerenone is a type of mineralocorticoid receptor antagonist, or MRA. These drugs work by blocking the receptor for the hormone aldosterone. Aldosterone makes the kidneys hold on to salt and water, which can raise your blood pressure. When the drug blocks the receptor, the kidneys release excess water and salt from the blood, which can also affect potassium levels, but the drug prevents the loss of potassium. It’s important to keep potassium at certain levels because too much in the blood can damage the heart, and low levels can affect certain functions in the body.

    The researchers found that people taking finerenone showed a higher risk of hyperkalemia, or having too much potassium in the blood. But very few of them – 0.5% of patients in the finerenone group and 0.2% in the placebo group – were hospitalized for hyperkalemia.

    “Any drug that works in this way, the mineralocorticoid receptor antagonists, will raise potassium in the blood,” Solomon said. “This is a very well-established and known side effect, but these drugs reduce the risk of low potassium, which also places patients at risk.”

    Bayer previously released top line results from this study in early August. In that announcement, Dr. Christian Rommel, head of research and development at Bayer’s Pharmaceuticals Division, said the company is “eager to bring finerenone to eligible patients as soon as possible.”

    A separate paper, published Sunday in The Lancet, reviewed four clinical trials on MRAs in heart failure and found “significant reductions” in heart failure hospitalizations among heart failure patients.

    The meta-analysis showed that steroidal MRAs reduced the risk of cardiovascular death or heart failure hospitalization in patients with heart failure who had reduced ejection fraction, and nonsteroidal MRAs reduced this risk in people with heart failure who had mildly reduced or preserved ejection fraction. Finerenone, a nonsteroidal MRA, was among the drugs in the trials.

    If the FDA expands the use of finerenone as a heart failure therapy, cardiologist Dr. Michelle Bloom said, she would think about it as an option for her patients with mildly reduced or preserved ejection fraction.

    “I would certainly consider using finerenone,” Bloom, heart failure cardiologist and system director of the Cardio-Oncology Program at NYU Langone Health in New York, said in an email.

    “However, I think the question is what the benefit of finerenone will be over the more traditional MRAs such as spironolactone and eplerenone. This remains to be answered,” she said.

    Overall, heart failure patients with preserved ejection fraction “have historically been difficult to treat and manage,” Dr. Jayne Morgan, an Atlanta-based cardiologist and vice president for medical affairs at the heart health company Hello Heart, said in an email.

    The new study “certainly provides support for additive therapy with finerenone. However certainly more data is needed, including independent data not financed by the sponsor,” Morgan said. “Further, we’d like to see more Blacks and minorities enrolled to truly make the data relevant to all sufferers.”

    In the study, the researchers noted that few Black patients were enrolled.

    Still, the study findings give “reason for cautious optimism,” Morgan said.

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  • What is ketamine, the drug involved in Matthew Perry’s death?

    What is ketamine, the drug involved in Matthew Perry’s death?

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    The investigation into the death of “Friends” star Matthew Perry has led to a sweeping indictment that pulled in five people who prosecutors say contributed to his ketamine overdose in October, including two doctors and a street dealer involved in providing Perry large amounts of the powerful anesthetic.

    Here’s what to know about ketamine.

    What is ketamine?

    Ketamine is a powerful anesthetic approved by U.S. health regulators for use during surgery. It can be given as an intramuscular injection or by IV.

    The drug is a chemical cousin of the recreational drug PCP. Ketamine itself has been used recreationally for its euphoric effects. It can cause hallucinations and can impact breathing and the heart.

    How was Matthew Perry using ketamine?

    Ketamine has seen a huge surge in use in recent years as a treatment for depression, anxiety and pain. While the drug isn’t approved for those conditions, doctors are free to prescribe drugs for so-called off-label uses.

    In Perry’s case, he was using it to treat depression. He was receiving ketamine infusion therapy from his physicians, but prosecutors said the actor turned to other sources when his doctors refused to give him more doses.

    Prosecutors said Thursday that Perry obtained ketamine illicitly through a network that included a pair of doctors, his assistant and a woman they dubbed the “Ketamine Queen.” Perry’s assistant, who has pleaded guilty to one count of conspiracy to distribute ketamine causing death, injected the actor with ketamine — including several times on the day he died.

    “We are not talking about legitimate ketamine treatment,” U.S. Attorney Martin Estrada said while announcing the charges. “We’re talking about two doctors who abused the trust they had, abused their licenses to put another person’s life at risk.”

    How else is ketamine being used?

    Ketamine also has been used by paramedics as a sedative, often while working alongside police when they believed subjects were out of control. Some states and agencies have begun to rethink the practice due to its dangers. The 2019 death in Colorado of a young Black man named Elijah McClain brought scrutiny to the practice and led to a pair of paramedics being convicted for giving McClain an overdose of ketamine.

    Overall, the practice of giving ketamine and other sedatives to people detained by police has spread quietly across the nation over the last 15 years, built on questionable science and backed by police-aligned experts, an investigation led by The Associated Press has found.

    ___

    The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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  • ‘Shoot me up with a big one’: A timeline of the last days of Matthew Perry

    ‘Shoot me up with a big one’: A timeline of the last days of Matthew Perry

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    LOS ANGELES — The arrest of five people in the overdose death of Matthew Perry has revealed key details about the final days of the “Friends” star, most of them spent in the throes of an addiction to the surgical anesthetic ketamine.

    Perry would die at age 54 on Oct. 28 after telling his assistant to shoot him up “with a big one.” Drawn from unsealed federal court documents and a medical examiner’s investigation, here’s a chronological look at the end of Perry’s life.

    September 30 — Perry and his live-in personal assistant, Kenneth Iwamasa, met at their home in the Pacific Palisades neighborhood of Los Angeles with Dr. Salvador Plasencia. Perry had been receiving ketamine treatments for depression — an increasingly common off-label use — from his regular doctor, but wasn’t able to get as much as he wanted. Plasencia texted a doctor friend in San Diego, Mark Chavez, who agreed to obtain ketamine for him.

    “I wonder how much this moron will pay,” Plasencia texted Chavez. The two met up the same day in Costa Mesa, halfway between Los Angeles and San Diego and exchanged at least four vials of ketamine.

    Plasencia returned to Perry’s house, where Iwamasa paid him $4,500 in cash for the vials. Plasencia gave Perry two injections of ketamine, and instructed Iwamasa on how to give the injections to the actor. Plasencia texted Chavez that the experience “felt like a bad movie.”

    October 2 — Iwamasa texted Plasencia saying he wanted to buy not just injection sessions, but to be left with more vials of ketamine, referring to it in agreed-upon code as “dr pepper.” Plasencia appeared, gave Perry the injections, and left behind the vials of the anesthetic.

    October 4 — Iwamasa injected Perry himself for the first time. He texted the doctor that he had found “the sweet spot” to put the needle into his boss, but that trying different spots on Perry had led to them running out, and they needed more. Plasencia texted Chavez asking if he could keep supplying the drug so they could become Perry’s “go-to.”

    October 6 — Iwamasa told Plasencia they were running low, and needed more. Plasencia went to Perry’s house and sold him one or more vials.

    October 8 — In a late night meetup at a Santa Monica shopping plaza, Plasencia sold Iwamasa four vials of ketamine for $6,000 in cash.

    October 10 — Iwamasa drove Perry to a public parking lot in Long Beach, where they met up with the doctor. He sold them more ketamine, and gave an injection to Perry while the actor sat in a car. On the same day, Iwamasa sought even more of the drug from an additional source of ketamine, reaching out to Erik Fleming, an acquaintance of Perry.

    October 11 — Fleming messaged Iwamasa that he can get ketamine from a woman he knows. “It’s unmarked but it’s amazing – he take one and try it and I have more if he likes,” Fleming wrote. The woman, Jasveen Sangha, was known to her customers as the “Ketamine Queen.” Fleming texted Iwamasa that she only deals “with high end and celebs. If it were not great stuff she’d lose her business.”

    October 12 — Plasencia went to Perry’s house, where he was paid $21,000 in cash, some of it owed to him for previous ketamine buys. While there he injected Perry. The actor immediately froze up and his blood pressure spiked. The assistant said the doctor told him, “let’s not do that again.”

    October 13 — Perry got a sample of Sangha’s ketamine and tried it. He and Iwamasa would ask for 25 vials of it, for which he would pay $5,500. Fleming dropped it off at Perry’s house a day later.

    On or around Oct. 20 — Perry received his last legal ketamine treatment from his regular physician, according to what a woman close to him whose name was redacted in official documents told medical examiner’s investigators. The woman said his previous doctor had given him treatments every other day, but his new doctor said Perry was doing well, his depression was managed, and he no longer needed so many treatments. The woman would tell investigators that she had believed Perry had been sober for 19 months and there had been no relapse.

    Around October 24 — Perry talked to the unidentified woman for the last time. She told investigators he had been in good spirits.

    October 25 — Iwamasa asked Fleming for another 25 vials of ketamine. After picking up $6,000 from Perry, Fleming picked up the ketamine from Sangha, who told him her own source is known as “Master Chef.” Meanwhile, Iwamasa gave Perry at least six shots of ketamine.

    October 26 — Iwamasa again gave Perry at least six shots of ketamine.

    October 27 — The assistant again gave the actor at least six shots of ketamine. With the supply coming from Fleming and Sangha, Perry and Iwamasa had been out of touch with Plasencia for about two weeks. Plasencia would text Iwamasa saying he had more to offer: “I know you mentioned taking a break. I have been stocking up.”

    About 8:30 a.m. — Acting at Perry’s direction, using syringes from Plasencia and ketamine from Sangha, Iwamasa gave Perry an injection.

    About 11 a.m. — Perry played pickleball, according to what Iwamasa told medical examiner’s investigators later in the day, though many elements of that initial story changed in his later talks to prosecutors.

    About 12:45 p.m. — Iwamasa gave Perry his second shot of the day, and the actor began watching a movie.

    Shortly before 1:30 p.m. — Iwamasa gave Perry his third and final injection of the day while Perry sat at his backyard jacuzzi. “Shoot me up with a big one,” Iwamasa remembered Perry telling him. The assistant then left to run errands.

    About 4 p.m. — Iwamasa returned home to find Perry face down in the jacuzzi. He jumped in, pulled Perry to the steps and called 911. Paramedics arrived minutes later and declared Perry dead. Coroner’s investigators would say ketamine was the primary cause of his death, with drowning a secondary cause.

    ___

    Iwamasa has pleaded guilty to conspiracy to distribute Ketamine. Fleming has pleaded guilty to distributing ketamine resulting in death. Both are cooperating with prosecutors.

    Chavez has agreed to plead guilty to conspiracy to distribute the drug. Plasencia and Sangha, the two main targets of the investigation, have pleaded not guilty to multiple felony counts.

    Plasencia’s lawyer Stefan Sacks said Thursday that everything his client did was in Perry’s best medical interest. Sangha’s attorney declined comment.

    Attorneys for the other three men did not respond to multiple messages seeking comment from The Associated Press.

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  • Matthew Perry’s death leads to sweeping indictment of 5, including doctors and a reputed dealer

    Matthew Perry’s death leads to sweeping indictment of 5, including doctors and a reputed dealer

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    LOS ANGELES (AP) — Nearly 10 months after the death of Matthew Perry, the long-simmering investigation into the ketamine that killed him came dramatically into public view with the announcement that five people had been charged with having roles in the overdose of the beloved “Friends” star.

    Here are key things to know about the case, including the two key figures who could be headed for trial and the possibility of the steepest of prison sentences.

    A sweeping set of indictments

    One or more arrests had been expected since investigators from three different agencies revealed in May they had been conducting a joint probe into how the 54-year-old Perry got such large amounts of ketamine.

    The actor had been among the growing number of patients using legal but off-label medical means to treat depression, or in other cases chronic pain, with the powerful surgical anesthetic.

    Recent reports suggested indictments might be imminent, but few outside observers, if any, knew how wide-ranging the prosecution would be, reaching much further than previous cases stemming from celebrity overdoses.

    When Michael Jackson died in 2009 from a lethal dose of the anesthetic propofol, his doctor was charged with providing it. After rapper Mac Miller died in 2017, two men who prosecutors described as a dealer and a middleman were convicted of providing fentanyl-laced oxycodone that helped kill him.

    But Perry’s case pulled in both, with indictments against doctors and illegal distributors who prosecutors say preyed on his long and public struggles with addiction. The investigation even went after the live-in personal assistant who prosecutors say helped him get ketamine and injected it directly into him before Perry was found dead in his hot tub on Oct. 28, 2023.

    “They knew what they were doing was risking great danger to Mr. Perry. But they did it anyway,” U.S. Attorney Martin Estrada said in announcing the charges.

    The prosecution was well under way even before the announcement. Two people including the assistant, Kenneth Iwamasa, and a Perry acquaintance, Eric Fleming, have pleaded guilty to conspiracy to distribute the drug. A San Diego physician, Dr. Mark Chavez, has agreed to enter a guilty plea.

    That leaves prosecutors free to pursue their two biggest targets.

    The doctor and the ‘Ketamine Queen’

    An indictment unsealed Thursday alleges Perry turned to Los Angeles doctor Salvador Plasencia when his regular doctors refused to give him more ketamine. Prosecutors allege Plasencia cashed in on Perry’s desperation and addiction, getting him to pay $55,000 in cash for large amounts of the drug in the two months before his death.

    “I wonder how much this moron will pay,” Plasencia texted a co-defendant, according to his indictment.

    He pleaded not guilty to seven counts of distribution of ketamine in an appearance in federal court on Thursday afternoon.

    Plasencia’s attorney, Stefan Sacks, said outside court that he “was operating with what he what he thought were the best of medical intentions,” and his actions “certainly didn’t rise to the level of criminal misconduct.”

    Prosecutors allege Jasveen Sangha, whom they describe as a drug dealer known to customers as the “Ketamine Queen,” provided the doses of the drug that actually killed Perry, injected into the actor by Iwamasa with syringes supplied by Plasencia.

    Sangha also pleaded not guilty. Her attorney Alexandra Kazarian derided the “queen” moniker as made-for-media consumption during the hearing. The lawyer declined comment on the case outside court.

    Prosecutors say the other doctor in the case, Chavez, helped Plasencia obtain the ketamine he gave to Perry, while Perry’s acquaintance, Fleming, helped get ketamine from Sangha to Perry.

    Chavez could get up to 10 years in prison, Iwamasa up to 15 years and Fleming up to 25 years.

    Multiple messages seeking comment from attorneys for the three men were not returned.

    Looking ahead to trial

    Sangha could get life in prison if convicted as charged, while Plasencia could get up to 120 years. Each has a trial date in October, but it is highly unlikely any would be facing a jury by then, and the two may be tried together. They also could face testimony from the co-defendants who reached plea agreements.

    Magistrate Judge Alka Sagar ruled Sangha should be held without bond while awaiting trial, citing prosecutors’ contentions that she had destroyed evidence and funded a lavish lifestyle with drug sales even after Perry’s death.

    The judge agreed to release Plasencia after he posted a $100,000 bond.

    His attorney argued the Perry case was “isolated” and the doctor should be allowed to treat patients who depended on him at his one-man practice while awaiting trial.

    “I’m not buying that argument,” Sagar said, but agreed Plasencia could see patients so long as they signed a document in which he acknowledged the charges.

    “People have probably already heard about it from the amount of press,” Sacks told the judge, noting if they hadn’t, they would soon.

    Records show Plasencia’s medical license has been in good standing with no records of complaints, though it is set to expire in October and he could face action. He already has surrendered his federal license to prescribe more dangerous drugs.

    What is ketamine?

    Ketamine is a powerful anesthetic approved by U.S. health regulators for use during surgery. It can be given as an intramuscular injection or by IV.

    The drug is a chemical cousin of the recreational drug PCP. Ketamine itself has been used recreationally for its euphoric effects. It can cause hallucinations and can impact breathing and the heart.

    Pushing back against ketamine

    Prosecutors and police presented the Perry case as part of a major pushback against a rise in the illegal use of ketamine that has shadowed the broadening of its legal use.

    Los Angeles police said in May they were working with the U.S. Drug Enforcment Administration and the U.S. Postal Inspection Service with a probe into how Perry got the drug. His autopsy, released in December, found the amount of ketamine in his blood was in the range used for general anesthesia during surgery.

    “As Matthew Perry’s ketamine addiction grew, he wanted more and he wanted it faster and cheaper. That is how he ended up buying from street dealers and stole the ketamine that ultimately led to his death,” U.S. Drug Enforcement Administrator Anne Milgram said Thursday. “In doing so, he followed the arc that we have tragically seen with many others. The substance use disorder begins in a doctor’s office and ends in the street.”

    Perry had years of struggles with addiction dating back to his time on NBC’s megahit sitcom, “Friends,” for 10 seasons from 1994 to 2004. Playing Chandler Bing, he became one of the biggest television stars of his generation alongside Jennifer Aniston, Courteney Cox, Lisa Kudrow, Matt LeBlanc and David Schwimmer.

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