With nearly all the new COVID-19 infections in the U.S. coming from the Omicron BA.4 and BA.5 subvariants, it makes sense that health officials are considering switching to a different vaccine to protect the public. White House COVID-19 response coordinator Dr. Ashish Jha expects the first Omicron-specific booster to be available in mid-September at the earliest, if the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) authorize and recommend the shot. In late August, both Pfizer-BioNTech and Moderna submitted requests to the FDA for authorization of their Omicron-specific boosters. But with the fall and winter fast approaching—the seasons when respiratory viruses like SARS-CoV-2 spread even more efficiently, as students return to school and people huddle indoors—getting the booster ready requires a more efficient review and regulatory process. And that includes considering safety and efficacy data from animals, not people. Back in June, the FDA’s panel of independent vaccine experts met to consider switching the country to a new booster that targets Omicron, given how quickly that variant is dominating new infections. At the time, the two largest COVID-19 vaccine makers, Pfizer-BioNTech and Moderna—which both make mRNA-based vaccines—had developed shots against an earlier Omicron variant, BA.1. The panel decided that if health authorities were going to change the booster shot to target Omicron, the next one should protect against the BA.4 and BA.5 subvariants, which would continue to account for almost all cases in the winter season. They asked the vaccine manufacturers to develop a new vaccine, one that combined the original vaccine and also targeted Omicron BA.4 and BA.5. At the end of August, both companies submitted data on their new, bivalent vaccines to the FDA for emergency use authorization. Given the short time they had to develop the shot, however, the data only included information on the safety and efficacy of the booster in animals. Human studies are planned and will be ongoing even if the FDA and CDC decide to authorize the shots and the government starts distributing them. The FDA has also decided to review the animal study data without consulting its advisory committee again. That has vaccine experts divided. Dr. Paul Offit, a member of the advisory committee, says this strategy makes him “uncomfortable” for several reasons. He notes that the data presented from Pfizer-BioNTech and Moderna in June involving their BA.1 booster shot, which focused on the levels of virus-fighting antibodies the vaccine generated, were underwhelming. “They showed that the neutralizing antibody titers were between 1.5- and two-fold greater against Omicron than levels induced by a booster of the ancestral vaccine,” he says. “I’d like to see clear evidence of dramatic increase in neutralizing antibodies, more dramatic than what we saw against BA.1, before launching a new product. We’re owed at least that.” While conducting human studies does take more time, Offit says even a small trial involving about 100 people to measure their antibody levels after getting a BA.4/5 booster would be helpful. “You can boost people and measure their neutralizing antibodies two weeks later,” he says. Such information could also be critical in setting realistic expectations for the Omicron booster. The public might feel it’s a panacea that signals the end of the pandemic, but without any data showing how well the booster will protect people from not only getting sick, there might be unrealistic expectations about what the boost can do. “I get a little nervous, frankly, when I hear this [booster] is going to be miraculous,” Offit says. Other experts see it a little differently. Based on the fact that the mRNA vaccines have been administered to millions of people so far, with relatively few safety concerns, and given that the vaccines have been effective in protecting people from getting hospitalized or dying of COVID-19, even during the latest Omicron surges, they argue that changing the strain of virus in the vaccine doesn’t require the same extensive testing that the original shot did. “The totality of evidence is relevant here,” says Dr. Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital, and also a member of the FDA’s vaccine advisory committee. “We are in a situation where we need to pivot as variants emerge, and if we try to be too rigid in our approach, we will always be behind, and not giving the population optimal protection.” Levy says that the latest Omicron-specific boosters that the FDA is considering contain a combination of mRNA targets against both the original virus and Omicron BA.4/BA.5, so the data on safety and efficacy from the original vaccine in protecting against hospitalization and death is relevant. While the data on this vaccine does come from animals, using that data to decide whether or not to authorize the booster is a matter of “hedging bets.” There is data showing that even vaccinated and boosted people can get mild to moderate COVID-19 disease, because their vaccine-induced protection is waning, so boosting with a shot that is better matched to the Omicron subvariants circulating now is a reasonable bet, even if the data on its efficacy comes from animals and not people. “I think it’s the right decision,” says Levy. There’s no guarantee that the FDA will authorize the new bivalent vaccines, although all signs point to an authorization that could come in a week or so. If the shots are released and people get boosted, health officials will be carefully monitoring data from those vaccinees to ensure that the assumptions they made about the safety and efficacy of the booster hold. And hospitalization rates in the coming winter will reveal whether betting on the new Omicron-specific booster was the right decision. from https://ift.tt/U18IPbn Check out https://takiaisfobia.blogspot.com/
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COVID-19 vaccine maker Moderna is suing Pfizer and the German drugmaker BioNTech, accusing its main competitors of copying Moderna’s technology in order to make their own vaccine. Moderna said Friday that Pfizer and BioNTech’s vaccine Comirnaty infringes on patents Moderna filed several years ago protecting the technology behind its preventive shot, Spikevax. The company filed patent infringement lawsuits in both U.S. federal court and a German court. A Pfizer spokeswoman declined to comment, saying the company had not been served with a copy of the litigation. Moderna and Pfizer’s two-shot vaccines both use mRNA technology to help patients fight the coronavirus. The mRNA vaccines work by injecting a genetic code for the spike protein that coats the surface of the coronavirus. That code, the mRNA, is encased in a little ball of fat, and instructs the body’s cells to make some harmless spike copies that train the immune system to recognize the real virus. Moderna CEO Stephane Bancel said in a prepared statement that the vaccine developer pioneered that technology and invested billions of dollars in creating it. The company said it believes its rivals’ vaccine infringes on patents Moderna filed between 2010 and 2016. from https://ift.tt/gys6b5D Check out https://takiaisfobia.blogspot.com/ Back in March, people 50 and over—and younger people with weakened immune systems—became eligible to receive a second booster shot. If you got your second booster recently, can you still get the new Omicron-specific booster that health officials are expecting in September or October? The answer is yes. The U.S. Food and Drug Administration (FDA) and U.S. Centers for Disease Control and Prevention (CDC) considered this very scenario in the spring before authorizing a second booster for this group, since they knew Omicron-specific boosters were likely forthcoming. They decided that taking a second booster would not preclude people from also getting the Omicron booster if and when it was authorized. The reason for that is because boosters are an important way to enhance waning immunity, and more studies show that the initial surge in virus-fighting antibodies that vaccines produce can decline over time. Topping off these levels with a booster shot is crucial in order to protect vulnerable people from getting seriously ill with COVID-19, and that’s what the vaccines have been doing—keeping people out of the hospital and dying of the disease. Getting a second booster shores up this protection, and when those antibody levels inevitably wane again, people would be eligible for the new Omicron-specific booster. It’s not a matter of getting one or the other, but getting both when the time comes. Read More: Why You Shouldn’t Wait for Updated COVID-19 Boosters If you qualify for one, getting a second booster as soon as possible is a good idea. “The threat to you [from BA.5] is now,” said Dr. Anthony Fauci, chief medical advisor to the White House, in a July press briefing. If you are not vaccinated to the fullest—namely, not gotten boosters according to the recommendations—you are putting yourself at increased risk.” Cases and deaths are still relatively high across the country; BA.5 is more transmissible than past variants and while vaccines won’t protect you from getting infected in the first place, they will provide some defense from getting hospitalized and getting severe COVID-19. The booster doses that the FDA is reviewing now—made by Pfizer-BioNTech and Moderna—are different from those that people have received so far. They are bivalent vaccines, meaning they’re directed against two strains of the virus: the original strain of SARS-CoV-2 that previous vaccines targeted, as well as the Omicron BA.4 and BA.5 subvariants, which now account for nearly all new infections in the U.S. Recent data show that even people who are vaccinated and boosted with the original strain are still susceptible to developing mild-to-moderate COVID-19 from the Omicron variants, so experts hope that the new booster shot will better protect people from getting sick from these circulating Omicron viruses. FDA and CDC officials have not yet decided who would qualify for Omicron boosters (though Pfizer-BioNTech recently asked for authorization of their shots for all Americans 12 and up, and Moderna submitted its application for adults 18 and older), when they would be available, and how long after a previous dose people should wait before getting it. The CDC’s vaccine advisory committee is scheduled to meet on September 1 and 2 and may issue more guidance then. from https://ift.tt/LRGtV0w Check out https://takiaisfobia.blogspot.com/ GENEVA — The number of monkeypox cases reported globally dropped by 21% in the last week, reversing a month-long trend of rising infections and a possible signal the outbreak in Europe may be starting to decline, according to a World Health Organization report issued Thursday. The U.N. health agency reported 5,907 new weekly cases and said two countries, Iran and Indonesia, reported their first cases. To date, more than 45,000 cases have been reported in 98 countries since late April. Cases in the Americas accounted for 60% of cases in the past month, WHO said, while cases in Europe comprised about 38%. It said infections in the Americas showed “a continuing steep rise.” The Africa Centers for Disease Control and Prevention said Thursday the continent had 219 new cases reported in the past week, a jump of 54%. Most were in Nigeria and Congo, the agency said. In early July, just weeks before the agency declared the international spread of the disease to be a global emergency, WHO’s Europe director said countries in the region were responsible for 90% of all laboratory confirmed cases of monkeypox. British health authorities said last week after seeing a decline in the number of new cases getting reported daily that there were “early signs” the country’s monkeypox outbreak was slowing. The U.K.’s Health Security Agency downgraded the country’s monkeypox outbreak last month, saying there was no evidence the once rare disease was spreading beyond men who were gay, bisexual or had sex with other men. Since monkeypox outbreaks in Europe and North America were identified in May, WHO and other health agencies have noted that its spread was almost exclusively in men who have sex with men. Read More: How the Monkeypox Virus Does—and Doesn’t—Spread Monkeypox has been endemic in parts of Africa for decades and experts suspect the outbreaks in Europe and North America were triggered after the disease started spreading via sex at two raves in Spain and Belgium. WHO’s latest report said 98% of cases are in men and of those who reported sexual orientation, 96% are in men who have sex with men. “Of all reported types of transmission, a sexual encounter was reported most commonly,” WHO said. “The majority of cases were likely exposed in a party with sexual contacts,” the agency said. Among the monkeypox cases in which the HIV status of patients was known, 45% were infected with HIV. WHO has recommended that men at high risk of the disease temporarily consider reducing their number of sex partners or refrain from group or anonymous sex. Monkeypox typically requires skin-to-skin or skin-to-mouth contact with an infected patient’s lesions to spread. People can also become infected through contact with the clothing or bedsheets of someone who has monkeypox lesions. With globally limited vaccine supplies, authorities in the U.S., Europe and the U.K. have all begun rationing doses to stretch supplies by up to five times. WHO has advised countries that have vaccines to prioritize immunization for those at high risk of the disease, including gay and bisexual men with multiple sex partners, and for health workers, laboratory staff and outbreak responders. While Africa has reported the most suspected deaths from monkeypox, the continent has no vaccine supplies apart from a very small stock being tested in a research study in Congo. “As we know, the situation with monkeypox vaccine access is very topical, but there are not enough doses of vaccines,” Nigeria Center for Disease Control Director-General Ifedayo Adetifa said this week. Potentially, a lot more more doses will become available, but because of challenges with manufacturing factories and unexpected uptick in monkeypox cases, the vaccine may actually not be available until 2023.” ___ Chinedu Asadu in Abuja, Nigeria, contributed reporting. from https://ift.tt/f9ngleM Check out https://takiaisfobia.blogspot.com/ Taking the antiviral treatment Paxlovid can reduce a person’s chances of getting seriously ill from COVID-19. But while seniors tend to get impressive protection from the pills, younger people derive little benefit, finds new research. In a study published Aug. 24 in the New England Journal of Medicine, researchers in Israel provide valuable real-world data on how effective the pills are against Omicron. The researchers studied data from 109,000 patients at a large health care organization—nearly all of whom had been vaccinated, had been previously infected, or both—and tracked their hospitalization and death rates by age. Nearly 4,000 people in the study, which was conducted from January to March 2022, took Paxlovid. People who were 65 or older had a 73% lower chance of being hospitalized for COVID-19 and about a 79% lower chance of dying of the disease, compared to people in the same age group who did not take Paxlovid. But people ages 40 to 64 experienced no statistically significant drop in the risk of hospitalization or death. Based on the findings, the authors conclude that “no evidence of benefit was found in younger adults.” To qualify for Paxlovid, patients must be at elevated risk of developing serious illness from COVID-19. Risk factors include older age, as well as conditions such as obesity, high blood pressure, diabetes, and a history of heart and kidney failure. But the Israeli data suggest that age may be an even more important consideration for evaluating who should take it. While the benefits are clear for seniors, the findings throw into question whether taking the drug is worth it for people under 65. It comes with potential side effects, including diarrhea, muscle aches, an increase in blood pressure, and an aftertaste so bad that it can temporarily affect some people’s ability to eat. Paxlovid also interacts with common medications, such as cholesterol-lowering statins, so some doctors advise patients to stop or reduce those medications during the five-day Paxlovid course. And there are increasing reports that people taking Paxlovid are likely to experience a rebound infection, or having the virus re-emerge after they stop taking the pills. One caveat of the study is that the researchers did not break down data on younger people with cancer and other severe immunocompromising conditions, who may be more likely than other young people to benefit from Paxlovid—perhaps to a greater extent than the data showed. As more people take the medications, doctors will have a better understanding of who will benefit most, and for whom the benefits outweigh the risks. from https://ift.tt/ca18sHm Check out https://takiaisfobia.blogspot.com/ By the time Jon Kostas was 25, he was desperate to beat his alcohol addiction. He had started drinking at age 13 and had cycled through different treatments—going to Alcoholics Anonymous meetings, taking pharmaceutical medications, and trying in-patient rehab—but nothing worked. Ever since 2015, however, when he took part in a clinical trial that combined talk therapy and psilocybin—the psychedelic active ingredient in magic mushrooms—Kostas has quit drinking. “I’m forever grateful and indebted,” he says. “This saved my life.” A randomized clinical trial, published Aug. 24 in the journal JAMA Psychiatry, found that in combination with psychotherapy, psilocybin helped treat people’s alcohol use disorder. Analyzing a group of 93 patients with the condition—Kostas among them— for 32 weeks, researchers found that patients who had received psilocybin plus psychotherapy (48 in total) reduced their drinking by 83% within eight months of their first dose, compared to 51% among those who had received a placebo. Nearly half of people treated with psilocybin stopped drinking completely, compared to less than a quarter of those who’d only received the placebo. “If these effects are replicated, I think this really would represent a breakthrough,” says Dr. Michael Bogenschutz, director of the New York University Langone Center for Psychedelic Medicine and the senior author of the study. “The effects seem to persist. And the effects are larger than those of any of the treatments that are currently available,” which includes methods like in-patient rehab, talk therapy, and medications. Read More: Inside Ibogaine, One of the Most Promising and Perilous Psychedelics for Addiction A more effective treatment for alcohol addiction could have profound, society-wide effects. About 95,000 Americans die from alcohol-related causes each year, including alcoholic liver disease and car accidents, according to the U.S. Centers for Disease Control and Prevention. A 2021 federal analysis of Americans pre-pandemic found that while about 5% of U.S. adults—about 14.1 million people—had alcohol use disorder in the last year, only 7% of them received any treatment, and just under 3% were treated with medication. Even when people receive treatment, however, approved medications such as naltrexone have been shown to only have limited effectiveness. The new research adds the strongest evidence yet that psilocybin may be a promising treatment for substance use disorders. Another preliminary study by Bogenschutz and other researchers in 2015 found that psilocybin-assisted therapy seemed to treat alcohol addiction in a small test group of patients. And a small study published in 2014 by Bogenschutz and some of the same researchers found that psilocybin combined with talk therapy can help people stop smoking. Last year, the team received the first federal grant for a psychedelic treatment in over 50 years to expand that research with a three-year, multisite study. Psilocybin’s effectiveness may have to do with how it affects the brain, says Bogenschutz. Research suggests that psilocybin promotes neuroplasticity, which allows people to change the way they think and behave. Researchers have also found that psilocybin helps treat depression—which often occurs alongside substance use disorder. One of the things that makes psilocybin such a promising treatment, says Bogenschutz, is that unlike medications that must be taken over and over again, psilocybin has a long-lasting, powerful effect after just a few doses. “It really suggests that we’re treating the underlying disorder, rather than simply treating the symptoms,” says Bogenschutz. Read More: How COVID-19 Opened the Door to a New Era in Psychedelic Medicine While the results of this study are encouraging, there’s still a long way to go before psilocybin can be used to treat a wider population. Fewer than 50 patients received psilocybin during the clinical trial, which means more research must be conducted on a larger, diverse population. Plus, the placebo used in the trial, diphenhydramine—an antihistamine—isn’t a perfect substitute for psilocybin, as psychedelic drugs produce unique hallucinogenic effects. Bogenschutz adds that people shouldn’t experiment with psilocybin outside of clinical settings, because it may be more risky in an uncontrolled environment, in part because patients’ experiences can feel extreme. For instance, some patients feel severe anxiety while under the drug’s influence. The study also didn’t include the full range of people who could benefit from psilocybin-assisted treatment. Bogenschutz noted that on average, participants tended to have less severe drinking intensity than people who typically join clinical trials for the condition. (According to Bogenschutz, that’s likely because the trial may have appealed to people who were already coping with their disorder.) The researchers also intentionally excluded patients with other mental health disorders, such as depression, to ensure they could determine whether psilocybin-assisted therapy treats alcohol addiction, and not some other underlying condition. However, Bogenschutz says it’s possible that patients with more severe disease might benefit even more from the treatment, especially if psilocybin can address the problems that underlie not only alcohol use disorder, but also mental-health issues like depression and anxiety, and even other kinds of substance use disorders. “People with co-occurring disorders and addictions might be an ideal population for this kind of treatment, because they might be able to benefit simultaneously for both disorders,” he says. Their hope is that “this more flexible pattern of brain function allows people to change their thoughts and behaviors in ways that allow them to be happier, healthier, people.” from https://ift.tt/zmTjfA1 Check out https://takiaisfobia.blogspot.com/ LANSING, Mich. — State and federal agencies are investigating an unknown illness that’s sickened dogs in northern Michigan and killed at least 30 canines in one county after they exhibited signs of a parvo-like illness. The Michigan Department of Agriculture and Rural Development said it’s working with local animal control shelters, veterinarians, the Michigan State University’s veterinary laboratory, the U.S. Department of Agriculture and other partners on testing to determine the illness’ cause. The state agency said “several dogs” have fallen ill with the same symptoms in the state’s northern Lower Peninsula with an illness similar to canine parvovirus, which affects a dog’s gastrointestinal tracts and is spread by dog-to-dog contact and contact with contaminated feces and environments. One veterinarian told MDARD officials about treating a dog that was vomiting and had diarrhea, which are common symptoms of canine parvovirus. That canine, however, tested negative for the parvovirus at a veterinary clinic, the agency said. The department said it has since heard from animal control agencies in northern Michigan regarding dogs with the same symptoms, the causes of which had not been determined. Read More: Dogs Can Sniff Out COVID-19 and Signs of Long COVID, Studies Suggest State Veterinarian Nora Wineland said in a statement that “investigating the details of unusual or reportable animal disease detections” is a key part of MDARD’s mission. In Otsego County, about 30 privately-owned and mostly unvaccinated dogs have died, said Melissa FitzGerald, the director of the county’s animal control department. She said it does not appear that the dogs had contact with each other. “It’s scary,” FitzGerald told the Detroit Free Press. “There are many things that it could be.” Adrianna Potrafkey, who lives in northern Michigan, said that in early July four of her dogs woke up with bloody diarrhea and upset stomachs. All of them have since recovered, which Potrafkey credits in part to the vaccines they received as puppies. She said she didn’t work for two straight weeks because she was worried about leaving her dogs alone, saying her veterinarian was mystified by what was making her dogs ill. “It impacted me a lot. I couldn’t leave them in case something happened,” she told WXMI-TV. MDARD said it was strongly encouraging dog owners to work with their veterinarian to ensure that their dog is up to date on routine vaccinations. A highly effective vaccine for parvovirus is available to protect dogs against that disease, the agency said. from https://ift.tt/1g8zxHb Check out https://takiaisfobia.blogspot.com/ Pfizer’s COVID-19 vaccine was 73% effective in protecting children younger than 5 as Omicron spread in the spring, the company announced Tuesday. Vaccinations for babies, toddlers, and preschoolers opened in the U.S. in June after months of delay. Only about 6% of youngsters ages 6 months through 4 years had gotten at least one dose of a COVID-19 vaccine by mid-August, according to the American Academy of Pediatrics. Health authorities authorized tot-sized vaccine doses made by Pfizer and its partner BioNTech based on a study showing they were safe and produced high levels of virus-fighting antibodies. But there was only preliminary data on how that translated into effectiveness against symptomatic COVID-19. There were 21 COVID-19 cases among the 351 tots who got dummy shots—compared to just 13 among the 794 youngsters given three vaccine doses. Read More: Half of People With Omicron Don’t Know They’re Infected, Study Says The child cases primarily were caused by the BA.2 Omicron version that was circulating at the time. Today, another Omicron relative, BA.5, is causing most COVID-19 cases in the U.S. and much of the world. In older children and adults, the COVID-19 vaccines have been used long enough to prove that they remain strongly protective against severe disease and death even as the coronavirus mutates—while early protection against infection wanes. Still, scientists track that initial effectiveness rate as extra evidence of vaccine performance—and to look for signs of how they initially hold up against new mutants. Pfizer this week asked U.S. regulators to authorize modified vaccine doses that better match the newest Omicron variants for people 12 and older as boosters this fall. The company said it also is developing updated shots for kids under 12. from https://ift.tt/QTP4BIh Check out https://takiaisfobia.blogspot.com/ Moderna Inc. completed its filing to request U.S. clearance for a booster shot that targets the latest Omicron COVID variants, a move to provide more protection against the persistent coronavirus. In a statement, the company said it had wrapped up the submission for emergency authorization for the company’s bivalent COVID booster vaccine that targets the BA.4 and BA.5 strains along with the original version of COVID. The filing includes preclinical data for the booster against the latest strains, along with clinical data from the company’s other bivalent booster that targets the original Omicron strain. Moderna said it would be ready to ship doses of the bivalent booster shot in September, if it were authorized in that time frame. Moderna’s booster application is for adults 18 years and older. Read More: Need Another Reason to Exercise? It Could Protect You from COVID-19 Advisers to the Centers for Disease Control and Prevention will hold a two-day meeting next week to discuss booster shots for COVID-19 vaccines, an agency spokesperson confirmed in an email. The Advisory Committee on Immunization Practices posted notice of the meeting, which will be held Sept. 1 and 2, on its website on Tuesday. The panel of outside experts advises the CDC on how best to administer new vaccines. No agenda for the meeting was posted. Vaccine makers are working to design shots that match the circulating strains of the coronavirus more closely in an attempt to give better protection against the pathogen that’s still spreading around the world more than 2 1/2 years after it was first detected in China. New cases in the US averaged about 95,000 in the seven days ending Aug. 17, according to the U.S. Centers for Disease Control and Prevention, but hospitalizations and deaths have fallen as more people gain immunity through vaccination and earlier exposures to the virus. Rival vaccine partners Pfizer Inc. and BioNTech SE said Monday they had sent data to the Food and Drug Administration seeking authorization for their own bivalent booster against BA.4 and BA.5 for people 12 and older. Pfizer said Tuesday that a three-dose regimen of its existing COVID vaccine was 73.2% effective against the disease in a trial in children ages 6 months through 4 years of age, adding to data that led to the shot’s authorization in young children in June. The companies are working with the FDA to prepare an application in kids ages 6 months through 11 years old for a bivalent booster targeting BA.4 and BA.5. Read More: COVID-19 May Have Long-Term Effects on the Brain Moderna shares rose less than 1% in late trading. Moderna said on Aug. 11 that it had started a clinical trial of the booster against BA.4 and BA.5. UK regulators have cleared another Moderna booster that focuses on the original Omicron strain. –With assistance from Fiona Rutherford. from https://ift.tt/2g3hv6B Check out https://takiaisfobia.blogspot.com/ Erinn Baldeschwiler, a 48-year-old with metastatic breast cancer, is struggling with anxiety and depression as she nears the untimely end of her life. “The last thing I want is to be terrified and scared and anxious, especially when I pass,” she says. She knows that no treatment can change the outcome of her disease. But she’s fighting for access to a different kind of therapeutic: psilocybin-assisted therapy, which past research has found can ease anxiety for depression in advanced cancer patients. Psilocybin (the active ingredient in magic mushrooms) and other potentially life-changing psychedelic drugs are being researched as mental-health treatments for conditions like anxiety, depression, and trauma. Advocates are optimistic that psilocybin and MDMA—which clinical trials have shown may be effective against post-traumatic stress disorder (PTSD)—could be approved by the U.S. Food and Drug Administration (FDA) within the next few years. But Baldeschwiler and other people with terminal illnesses can’t wait that long. “I’m going to be dead by then,” she says. “It’s a time issue. If you could provide an option that would provide immediate, sustained relief of depression, anxiety, and lead to a sense of peace as [someone is] going through their final days—why would you not want that as an option?” Read More: Inside Ibogaine, One of the Most Promising and Perilous Psychedelics for Addiction Some are arguing that both psilocybin and MDMA should already be available to qualifying patients through the federal Right to Try law. The 2018 law states that patients with life-threatening illnesses who have exhausted all treatment options can access drugs that have passed through Phase 1 testing—the first phase of clinical trials that tests drugs in humans—but have not been approved by the FDA. Psilocybin and MDMA fit those criteria, and so does Baldeschwiler. But the drugs’ Schedule 1 status—meaning the DEA deems them to have “no currently accepted medical use and a high potential for abuse” (a characterization that advocates for psychedelics dispute)—is keeping them back from patients. Baldeschwiler’s palliative care physician, Dr. Sunil Aggarwal, reached an agreement with a drug manufacturer to receive psilocybin. However, after Aggarwal applied to the Drug Enforcement Administration (DEA) to receive a waiver to provide the drug, the DEA refused, declaring in February 2021 that it had no authority to waive the Controlled Substances Act. Baldeschwiler and Aggarwal are now working with Kathryn Tucker, a lawyer focused on expanding access to psychedelics for groups including terminally ill people, to compel the DEA to allow use of psilocybin under the Right to Try law, which Tucker argues should supersede the Controlled Substances Act establishing the U.S.’s drug policy. The DEA is “thwarting operation of duly enacted federal law,” says Tucker. “If a physician deems their patient to have a life-threatening condition that could be addressed with one of the eligible investigational drugs, then that physician can seek [Right to Try] access, and should be granted it.” Advocates argue that the law has a particularly broad mandate. “The lack of an exclusion makes it clear that there is no exclusion” for Schedule 1 substances, Tucker says. The DEA declined TIME’s request for further comment, citing ongoing litigation. Read More: I Took A Psychedelic Drug for My Cancer Anxiety. It Changed My Life Psychedelic medicine is still an unsettled science that will require much more research before scientists fully understand how well it works, and for whom—especially given that many of the clinical trials that have tested psychedelic drugs are very small. Psychedelic drugs come with some risks, and patients who participate in trials generally meet certain health criteria. (Clinical trials for psilocybin, for instance, exclude patients who have close relatives with a history of schizophrenia or bipolar disorder.) However, advocates for expanding access argue that psilocybin- and MDMA-assisted psychotherapy fit neatly within the founding principle of the Right to Try law: patients faced with potential death should have the ability to try new drugs that could help them. The advocates’ case has won them some powerful bipartisan allies. On July 20, Senators Cory Booker (D-NJ) and Rand Paul (R-Ky.) introduced the Right to Try Clarification Act, to make it clear that the legislation encompasses Schedule 1 substances so long as they’ve been through Phase 1 clinical trials. Many advocates, like retired Marine Corp Lt. Gen. Martin Steele, believe that people who are at risk of dying by suicide and have exhausted all other treatment options should also be able to receive psychedelic assisted treatment. Steele is co-founder of the nonprofit Reason for Hope, an activist group promoting psychedelic treatment access and research. He recently testified in support of a Connecticut law enacted in April establishing a pilot program to let veterans, retired first responders, and retired health care workers receive MDMA and psilocybin-assisted therapy. Nationally, people are exposed to “unprecedented levels of stress and trauma,” he says. “We all know the current treatments are inadequate, and things are only getting worse.” Read More: Psilocybin Could be a Therapeutic Breakthrough For Addiction Veterans with PTSD are a particular area of focus in the fight to expand psychedelic access. “Currently, even in the best circumstances, our treatments probably help about half of the patients with PTSD,” and many also have treatment-resistant depression, says retired Brigadier Gen. Dr. Stephen Xenakis, a psychiatrist who served in the Army and volunteers with Reason for Hope. The U.S. has a moral responsibility to offer them a treatment that can help, he says. Given that about 17 U.S. veterans die by suicide every day in the U.S., “too many people are going to die” if veterans are forced to wait for FDA approval. “All of us should be shouting from the rooftops that something has to change,” says Lynnette Averill, an associate professor of psychiatry and behavioral sciences at Baylor College of Medicine who has studied how psychedelics can help special-operations veterans and is part of Reason for Hope. “Given the crisis that we are in, we cannot wait another year—or 2, 5, or 10—for these to be fully approved.” from https://ift.tt/vEQDHlZ Check out https://takiaisfobia.blogspot.com/ |
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