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Straits Times
7 days ago
- Business
- Straits Times
From no hope to a potential cure for a deadly blood cancer
The immunotherapy developed by Legend Biotech, a company founded in China, seems to have made their cancer disappear. PHOTO: UNSPLASH From no hope to a potential cure for a deadly blood cancer NEW YORK - A group of 97 patients had long-standing multiple myeloma, a common blood cancer that doctors consider incurable, and faced a certain, and extremely painful, death within about a year. They had gone through a series of treatments, each of which controlled their disease for a while. But then it came back, as it always does. They reached the stage where they had no more options and were facing hospice. They all got immunotherapy, in a study that was a last-ditch effort. A third responded so well that they got what seems to be an astonishing reprieve. The immunotherapy developed by Legend Biotech, a company founded in China, seems to have made their cancer disappear. And after five years, it still has not returned in those patients – a result never before seen in this disease. These results, in patients whose situation had seemed hopeless, has led some battle-worn American oncologists to dare to say the words 'potential cure.' 'In my 30 years in oncology, we haven't talked about curing myeloma,' said Dr Norman Sharpless, a former director of the National Cancer Institute who is now a professor of cancer policy and innovation at the University of North Carolina School of Medicine. 'This is the first time we are really talking seriously about cure in one of the worst malignancies imaginable.' The new study, reported on June 3 at the annual conference of the American Society of Clinical Oncology and published in The Journal of Clinical Oncology, was funded by Johnson & Johnson, which has an exclusive licensing agreement with Legend Biotech. The 36,000 Americans who develop multiple myeloma each year face an illness that eats away at bones, so it looks as if holes have been punched out in them, said Dr Carl June, of the University of Pennsylvania. Bones collapse. Dr June has seen patients who lost 6 inches (15.24cm) in height. 'It's a horrible, horrible death,' Dr June said. 'Right now advanced myeloma is a death sentence.' (Dr June has immunotherapy patents that are owned by his university.) There have been treatment advances that increased median survival from two years to 10 over the past two decades. But no cures. Dr Peter Voorhees of the Atrium Health Levine Cancer Institute in North Carolina and the Wake Forest University School of Medicine, who is lead researcher for the newly published study, said patients usually go through treatment after treatment until, ultimately, the cancer prevails, developing resistance to every class of drug. They end up with nothing left to try. The Legend immunotherapy is a type known as CAR-T. It is delivered as an infusion of the patient's own white blood cells that have been removed and engineered to attack the cancer. The treatment has revolutionised prospects for patients with other types of blood cancer, like leukaemia. Making CAR-T cells, though, is an art, with so many possible variables that it can be hard to hit on one that works. And it can have severe side effects including a high fever, trouble breathing and infections. Patients can be hospitalised for weeks after receiving it. But Legend managed to develop one that works in multiple myeloma, defying sceptics. The Chinese company gained attention for its CAR-T eight years ago when it made extravagant claims, which were met by snickers from American researchers. Johnson & Johnson, though, was looking for a CAR-T to call its own. So, said Mr Mark Wildgust, an executive in the oncology section of the American drug giant, the company sent scientists and physicians to China to see if the claims were true. 'We went site by site to look at the results,' he said. The company was convinced. It initiated a collaboration with Legend and began testing the treatment in patients whose myeloma had overcome at least one standard treatment. Compared with patients who had standard treatment, those who had the immunotherapy lived longer without their disease progressing. The immunotherapy received regulatory approval in that limited setting and is sold under the brand name Carvykti. The study did not determine whether this difficult treatment saved lives. The new study took on a different challenge – helping patients at the end of the line after years of treatments. Their immune systems were worn down. They were, as oncologists said, 'heavily pretreated.' So even though CAR-T is designed to spur their immune systems to fight their cancer, it was not clear their immune systems were up to it. Oncologists say that even though most patients did not clear their cancer, having a third who did was remarkable. To see what the expected life span would be for these patients without the immunotherapy, Johnson & Johnson looked at data from patients in a registry who were like the ones in its study – they had failed every treatment. They lived about a year. For Ms Anne Stovell of New York, one of the study patients whose cancer disappeared, the result is almost too good to be true. She says she went through nine drugs to control her cancer after it was diagnosed in 2010, some of which had horrendous side effects. Each eventually failed. Taking the Legend CAR-T was difficult – she said she had spent nearly three weeks in the hospital. But since that treatment six years ago, she has no sign of cancer. She said it was still difficult for her to believe her myeloma is gone. A new ache – or an old one – can bring on the fear. 'There's that little seed of doubt,' she said. But in test after test, the cancer has not reappeared. 'It's a relief for me every year to get a bone marrow biopsy,' she said. Myeloma experts applauded the results. Like treatments for many other cancers, treatments for multiple myeloma come with a high price. The drugs are 'hideously expensive,' Dr June said, costing more than US$100,000 (S$129,143) a year. The total cost over the years can be millions of dollars, Dr June said, usually paid by insurers, 'and it doesn't even cure you.' CAR-T is expensive too. Carvykti's list price is US$555,310. But it is a one-time treatment. And, more important, the hope is that perhaps by giving it earlier in the course of the disease, it could cure patients early on. Johnson & Johnson is now testing that idea. Dr Kenneth Anderson, a myeloma expert at Dana-Farber Cancer Institute who was not involved with the study, said that if the treatment is used as a first-line treatment, 'cure is now our realistic expectation.' That, at least, is the hope, Dr Sharpless said. And for those like the patients in the new study who are living at least five years – so far – without disease, the outcome 'really is eye-popping,' Dr Sharpless said. 'That's getting to a point where you wonder if it will ever come back,' he added. NYTIMES Join ST's Telegram channel and get the latest breaking news delivered to you.
Boston Globe
7 days ago
- Business
- Boston Globe
From no hope to a potential cure for a deadly blood cancer
A third responded so well that they got what seems to be an astonishing reprieve. The immunotherapy developed by Legend Biotech, a company founded in China, seems to have made their cancer disappear. And after five years, it still has not returned in those patients -- a result never before seen in this disease. Advertisement These results, in patients whose situation had seemed hopeless, has led some battle-worn American oncologists to dare to say the words 'potential cure.' Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up 'In my 30 years in oncology, we haven't talked about curing myeloma,' said Dr. Norman Sharpless, a former director of the National Cancer Institute who is now a professor of cancer policy and innovation at the University of North Carolina School of Medicine. 'This is the first time we are really talking seriously about cure in one of the worst malignancies imaginable.' The new study, reported Tuesday at the annual conference of the American Society of Clinical Oncology and published in The Journal of Clinical Oncology, was funded by Johnson & Johnson, which has an exclusive licensing agreement with Legend Biotech. The 36,000 Americans who develop multiple myeloma each year face an illness that eats away at bones, so it looks as if holes have been punched out in them, said Dr. Carl June, of the University of Pennsylvania. Bones collapse. June has seen patients who lost 6 inches in height. Advertisement 'It's a horrible, horrible death,' June said. 'Right now advanced myeloma is a death sentence.' (June has immunotherapy patents that are owned by his university.) There have been treatment advances that increased median survival from two years to 10 over the past two decades. But no cures. Dr. Peter Voorhees of the Atrium Health Levine Cancer Institute in North Carolina and the Wake Forest University School of Medicine, who is lead researcher for the newly published study, said patients usually go through treatment after treatment until, ultimately, the cancer prevails, developing resistance to every class of drug. They end up with nothing left to try. The Legend immunotherapy is a type known as CAR-T. It is delivered as an infusion of the patient's own white blood cells that have been removed and engineered to attack the cancer. The treatment has revolutionized prospects for patients with other types of blood cancer, like leukemia. Making CAR-T cells, though, is an art, with so many possible variables that it can be hard to hit on one that works. And it can have severe side effects including a high fever, trouble breathing and infections. Patients can be hospitalized for weeks after receiving it. But Legend managed to develop one that works in multiple myeloma, defying skeptics. The Chinese company gained attention for its CAR-T eight years ago when it made extravagant claims, which were met by snickers from American researchers. Advertisement Johnson & Johnson, though, was looking for a CAR-T to call its own. So, said Mark Wildgust, an executive in the oncology section of the American drug giant, the company sent scientists and physicians to China to see if the claims were true. 'We went site by site to look at the results,' he said. The company was convinced. It initiated a collaboration with Legend and began testing the treatment in patients whose myeloma had overcome at least one standard treatment. Compared with patients who had standard treatment, those who had the immunotherapy lived longer without their disease progressing. The immunotherapy received regulatory approval in that limited setting and is sold under the brand name Carvykti. The study did not determine whether this difficult treatment saved lives. The new study took on a different challenge -- helping patients at the end of the line after years of treatments. Their immune systems were worn down. They were, as oncologists said, 'heavily pretreated.' So even though CAR-T is designed to spur their immune systems to fight their cancer, it was not clear their immune systems were up to it. Oncologists say that even though most patients did not clear their cancer, having a third who did was remarkable. To see what the expected life span would be for these patients without the immunotherapy, Johnson & Johnson looked at data from patients in a registry who were like the ones in its study -- they had failed every treatment. They lived about a year. For Anne Stovell of New York, one of the study patients whose cancer disappeared, the result is almost too good to be true. She says she went through nine drugs to control her cancer after it was diagnosed in 2010, some of which had horrendous side effects. Each eventually failed. Advertisement Taking the Legend CAR-T was difficult -- she said she had spent nearly three weeks in the hospital. But since that treatment six years ago, she has no sign of cancer. She said it was still difficult for her to believe her myeloma is gone. A new ache -- or an old one -- can bring on the fear. 'There's that little seed of doubt,' she said. But in test after test, the cancer has not reappeared. 'It's a relief for me every year to get a bone marrow biopsy,' she said. Myeloma experts applauded the results. Like treatments for many other cancers, treatments for multiple myeloma come with a high price. The drugs are 'hideously expensive,' June said, costing more than $100,000 a year. The total cost over the years can be millions of dollars, June said, usually paid by insurers, 'and it doesn't even cure you.' CAR-T is expensive too. Carvykti's list price is $555,310. But it is a one-time treatment. And, more important, the hope is that perhaps by giving it earlier in the course of the disease, it could cure patients early on. Johnson & Johnson is now testing that idea. Dr. Kenneth Anderson, a myeloma expert at Dana-Farber Cancer Institute who was not involved with the study, said that if the treatment is used as a first-line treatment, 'cure is now our realistic expectation.' That, at least, is the hope, Sharpless said. And for those like the patients in the new study who are living at least five years -- so far -- without disease, the outcome 'really is eye-popping,' Sharpless said. Advertisement 'That's getting to a point where you wonder if it will ever come back,' he added. This article originally appeared in
Indian Express
03-06-2025
- Business
- Indian Express
From no hope to a potential cure for a deadly blood cancer
A group of 97 patients had longstanding multiple myeloma, a common blood cancer that doctors consider incurable, and faced a certain, and extremely painful, death within about a year. They had gone through a series of treatments, each of which controlled their disease for a while. But then it came back, as it always does. They reached the stage where they had no more options and were facing hospice. They all got immunotherapy, in a study that was a last-ditch effort. A third responded so well that they got what seems to be an astonishing reprieve. The immunotherapy developed by Legend Biotech, a company founded in China, seems to have made their cancer disappear. And after five years, it still has not returned in those patients — a result never before seen in this disease. These results, in patients whose situation had seemed hopeless, has led some battle-worn American oncologists to dare to say the words 'potential cure.' 'In my 30 years in oncology, we haven't talked about curing myeloma,' said Dr. Norman Sharpless, a former director of the National Cancer Institute who is now a professor of cancer policy and innovation at the University of North Carolina School of Medicine. 'This is the first time we are really talking seriously about cure in one of the worst malignancies imaginable.' The new study, reported Tuesday at the annual conference of the American Society of Clinical Oncology and published in The Journal of Clinical Oncology, was funded by Johnson & Johnson, which bought Legend Biotech. The 36,000 Americans who develop multiple myeloma each year face an illness that eats away at bones, so it looks as though holes have been punched out in them, said Dr. Carl June, of the University of Pennsylvania. Bones collapse. Dr. June has seen patients who lost six inches in height. 'It's a horrible, horrible death,' Dr. June said. 'Right now advanced myeloma is a death sentence.' (Dr. June has immunotherapy patents that are owned by his university.) There have been treatment advances that increased median survival from two years to 10 over the past two decades. But no cures. Dr. Peter Voorhees of the Atrium Health Levine Cancer Institute in North Carolina and the Wake Forest University School of Medicine, who is lead researcher for the newly published study, said patients usually go through treatment after treatment until, ultimately, the cancer prevails, developing resistance to every class of drug. They end up with nothing left to try. The Legend immunotherapy is a type known as CAR-T. It is delivered as an infusion of the patient's own white blood cells that have been removed and engineered to attack the cancer. The treatment has revolutionized prospects for patients with other types of blood cancer, like leukemia. Making CAR-T cells, though, is an art, with so many possible variables that it can be hard to hit on one that works. And it can have severe side effects including a high fever, trouble breathing and infections. Patients can be hospitalized for weeks after receiving it. But Legend managed to develop one that works in multiple myeloma, defying skeptics. The Chinese company gained attention for its CAR-T eight years ago when it made extravagant claims, which were met by snickers from American researchers. Johnson & Johnson, though, was looking for a CAR-T to call its own. So, said Mark Wildgust, an executive in the oncology section of the American drug giant, the company sent scientists and physicians to China to see if the claims were true. 'We went site by site to look at the results,' he said. The company was convinced. It bought Legend and began testing the treatment in patients whose myeloma had overcome at least one standard treatment. Compared with patients who had standard treatment, those who had the immunotherapy lived longer without their disease progressing. The immunotherapy received regulatory approval in that limited setting and is sold under the brand name Carvykti. The study did not determine whether this difficult treatment saved lives. The new study took on a different challenge — helping patients at the end of the line after years of treatments. Their immune systems were worn down. They were, as oncologists said, 'heavily pretreated.' So even though CAR-T is designed to spur their immune systems to fight their cancer, it was not clear their immune systems were up to it. Oncologists say that even though most patients did not clear their cancer, having a third who did was remarkable. To see what the expected life span would be for these patients without the immunotherapy, Johnson & Johnson looked at data from patients in a registry who were like the ones in its study — they had failed every treatment. They lived about a year. For Anne Stovell of New York, one of the study patients whose cancer disappeared, the result is almost too good to be true. She says she went through nine drugs to control her cancer after it was diagnosed in 2010, some of which had horrendous side effects. Each eventually failed. Taking the Legend CAR-T was difficult — she said she had spent nearly three weeks in the hospital. But since that treatment six years ago, she has no sign of cancer. She said it was still difficult for her to believe her myeloma is gone. A new ache — or an old one — can bring on the fear. 'There's that little seed of doubt,' she said. But in test after test, the cancer has not reappeared. 'It's a relief for me every year to get a bone marrow biopsy,' she said. Myeloma experts applauded the results. Like treatments for many other cancers, treatments for multiple myeloma come with a high price. The drugs are 'hideously expensive,' Dr. June said, costing more than $100,000 a year. The total cost over the years can be millions of dollars, Dr. June said, usually paid by insurers, 'and it doesn't even cure you.' CAR-T is expensive too. Carvykti's list price is $555,310. But it is a one-time treatment. And, more important, the hope is that perhaps by giving it earlier in the course of the disease, it could cure patients early on. Johnson & Johnson is now testing that idea. Dr. Kenneth Anderson, a myeloma expert at Dana-Farber Cancer Institute who was not involved with the study, said that if the treatment is used as a first-line treatment, 'cure is now our realistic expectation.' That, at least, is the hope, Dr. Sharpless said. And for those like the patients in the new study who are living at least five years — so far — without disease, the outcome 'really is eye-popping,' Dr. Sharpless said. 'That's getting to a point where you wonder if it will ever come back,' he added. Gina Kolata reports on diseases and treatments, how treatments are discovered and tested, and how they affect people.
Medscape
02-06-2025
- Business
- Medscape
EoE Prevalence in US Reaches 1 in 700, Costs $1B Annually
The prevalence of eosinophilic esophagitis (EoE) has increased fivefold in the United States since 2009, now affecting about 1 in 700 people and totaling $1.32 billion in annual healthcare costs, according to recent research. Although EoE has been considered a rare disease, the chronic condition is becoming more common, and healthcare providers should expect to encounter EoE in clinical settings, the study authors wrote. 'Our last assessment of the prevalence and burden of EoE was more than 10 years ago, and we had a strong suspicion we would continue to see increased numbers of patients with EoE and an increasing cost burden related to the condition in the United States,' said senior author Evan S. Dellon, MD, MPH, professor of gastroenterology and hepatology and director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina School of Medicine, Chapel Hill, North Carolina. 'EoE is becoming more common,' Dellon said. 'Healthcare providers should expect to see EoE in their practices, including in the primary care setting, emergency departments, allergy practices, GI [gastrointestinal] practices, ENT [ear, nose, and throat] clinics, and endoscopy suites.' The study was published in Clinical Gastroenterology and Hepatology . Estimating EoE Prevalence Dellon and colleagues analyzed the Merative MarketScan Commercial Claims and Encounters and Medicare Fee-for-Service databases to calculate the annual prevalence of EoE, as well as age- and sex-stratified estimates standardized to the US population. They also calculated healthcare utilization, including medications and endoscopic procedures, to estimate annual EoE-associated costs. Since the EoE billing code was introduced in 2008, the analysis included 2009-2022 MarketScan and 2009-2017 Medicare data. In the MarketScan database, the research team identified 20,435 EoE cases in 2022, with a mean age of 38 years, 16% younger than 18 years, 62% men, and 41% with a comorbid allergic disease code. The most common symptoms and diagnoses were dysphagia (39%), abdominal pain or dyspepsia (24%), and esophageal stricture (19%). Over time, patients also had previous codes for comorbid allergic diseases (64%), dysphagia (62%), or esophageal stricture (32%). In the Medicare database, the research team identified 1913 EoE cases in 2017, with a mean age of 73 years, 47% men, 90% non-Hispanic White, and 36% with a comorbid allergic disease. The most common symptoms and diagnoses were dysphagia (49%), abdominal pain or dyspepsia (35%), and esophageal stricture (30%). Over time, patients also had codes for comorbid allergic diseases (64%), dysphagia (65%), or esophageal stricture (42%). The database numbers translated to EoE prevalences of about 163 cases per 100,000 people in MarketScan in 2022 and 64 cases per 100,000 people in Medicare in 2017. Since 2009, there has been a fivefold increase in prevalence in both databases. In MarketScan, the prevalence was higher among men than among women, at 204 vs 122 cases per 100,000 people. For both sexes, peak prevalence occurred between ages 40 and 44. In Medicare, prevalence was also higher among men than among women, at 79 vs 55 cases per 100,000 people. Peak prevalence occurred between ages 65 and 69. Standardized to the US population, EoE prevalence was 142.5 cases per 100,000 people, extrapolating to 472,380 cases. The overall prevalence was approximately 1 in 700, with rates of 1 in 617 for those younger than 65 years and 1 in 1562 for those aged ≥ 65 years. 'The rapidly increasing prevalence year over year for the entire timeframe of the study was surprising, as were our estimates of the total number of EoE patients in the US, which suggests that EoE is no longer a rare disease and is now seen in about 1 in 700 people,' Dellon said. 'This almost triples our prior estimates of 1 in 2000 from 10 years ago, with all trends suggesting that the prevalence will continue to increase.' Calculating EoE Costs In terms of procedures, endoscopy with dilation or biopsy was used in about 60%-70% of patients with EoE in both MarketScan and Medicare during the years analyzed. In addition, upper endoscopy with biopsy was coded in 80%-90% of patients, guidewire-based dilation in 11%-17% of patients, and balloon-based dilation in 13%-20% of patients. In terms of prescription medications, proton pump inhibitors (41%) and topical steroids (26%) were the most common in MarketScan in 2022, as well as in Medicare in 2017, at 32% and 9%, respectively. When looking at costs by age and sex, the male cohort with the highest costs was aged 10-14 years, estimated at $106.7 million. Among the female cohort, the highest costs were associated with ages 15-19, estimated at $46.5 million. Overall, total EoE-associated healthcare costs were estimated to be $1.04 billion in 2017, and when adjusted for inflation, the costs were estimated at $1.32 billion in 2024. This is likely an underestimate, the authors wrote, given that EoE prevalence has likely increased for ages 65 or older since 2017 and for all ages since 2022. 'Researching the prevalence and costs is essential to improving patient care by highlighting the growing burden of this recently recognized and growing chronic disease, guiding policy and insurer decisions, and advocating for better access to effective treatments and support for patients,' said Joy Chang, MD, assistant professor of medicine in the Division of Gastroenterology, University of Michigan, Ann Arbor, Michigan. Chang, who wasn't involved with this study, specializes in eosinophilic GI diseases and researches patient-physician preferences and decision-making in EoE care. 'Clinicians should remain vigilant for symptoms, utilize guideline-based diagnostic approaches, and consider both medical and dietary treatment strategies to optimize patient outcomes and reduce long-term costs,' she said. 'Increased awareness and timely intervention can help mitigate the growing impact of this chronic condition.' The study was supported by a National Institutes of Health grant and used resources from the University of North Carolina Center for Gastrointestinal Biology and Disease. Dellon reported receiving research funding from and having consultant roles with numerous pharmaceutical companies and organizations. Chang reported having no relevant disclosures.
Yahoo
24-03-2025
- Health
- Yahoo
The Colorado psychedelic mushroom experiment has arrived
This is a . Colorado regulators are issuing licenses for providing psychedelic mushrooms and are planning to authorize the state's first "healing centers," where the mushrooms can be ingested under supervision, in late spring or early summer. The dawn of state-regulated psychedelic mushrooms has arrived in Colorado, nearly two years since Oregon began offering them. The mushrooms are a Schedule I drug and illegal under federal law except for clinical research. But more than a dozen cities nationwide have deprioritized or decriminalized them in the past five years, and many eyes are turned toward Oregon's and Colorado's state-regulated programs. "In Oregon and Colorado, we're going to learn a lot about administration of psychedelics outside of clinical, religious and underground settings because they're the first to try this in the U.S.," said William R. Smith, an assistant professor of psychiatry at the University of North Carolina School of Medicine. MORE: Mom says microdosing mushrooms makes her a 'present' parent Psychedelic mushrooms and their psychoactive compound psilocybin have the potential to treat people with depression and anxiety, including those unresponsive to other medications or therapy. The National Institute on Drug Abuse, part of the National Institutes of Health, says the risk of mental health problems caused by ingesting mushrooms in a supervised clinical setting is low, but may be higher outside of a clinical setting. Robert F. Kennedy Jr. said in a social media post last year, before his nomination as U.S. health secretary, that his "mind is open to the idea of psychedelics for treatment." Medical experts say more research is needed, particularly in people with a diagnosis or family history of psychotic or bipolar disorder. Adverse effects of psilocybin, including headache and nausea, typically resolve within one to two days. However, extended difficulties from using psychedelics can last weeks, months or years; anxiety and fear, existential struggle, social disconnection and feeling detached from oneself and one's surroundings are most common. After the decriminalization and legalization in Oregon and Colorado, psychedelic mushroom exposures reported to poison control centers ticked up in these states and nationally. In February, about 40 people organized by the psychedelic advocacy group the Nowak Society gathered in Boulder to talk about the coming changes in Colorado. They included Mandy Grace, who received her state license to administer psychedelic mushrooms, and Amanda Clark, a licensed mental health counselor from Denver, who both praised the therapeutic power of mushrooms. "You get discouraged in your practice because the current therapies are not enough for people," Clark said. Colorado voters approved Proposition 122 in 2022 to legalize natural psychedelics, after Oregon voters in 2020 approved legalizing psilocybin for therapeutic use. Colorado's program is modeled after, but not the same as, Oregon's, under which 21,246 psilocybin products have been sold as of March, a total that could include secondary doses, according to the Oregon Health Authority. As of mid-March, Colorado has received applications for at least 15 healing center licenses, nine cultivation licenses, four manufacturer licenses and one testing facility license for growing and preparing the mushrooms, under rules developed over two years by the governor-appointed Natural Medicine Advisory Board. Psychedelic treatments in Oregon are expensive, and are likely to be so in Colorado, too, said Tasia Poinsatte, Colorado director of the nonprofit Healing Advocacy Fund, which supports state-regulated programs for psychedelic therapy. In Oregon, psychedelic mushroom sessions are typically $1,000 to $3,000, are not covered by insurance, and must be paid for up front. MORE: Australia will allow prescription MDMA and magic mushrooms for some people with mental illness The mushrooms themselves are not expensive, Poinsatte said, but a facilitator's time and support services are costly, and there are state fees. In Colorado, for doses over 2 milligrams, facilitators will screen participants at least 24 hours in advance, then supervise the session in which the participant consumes and experiences mushrooms, lasting several hours, plus a later meeting to integrate the experience. Facilitators, who may not have experience with mental health emergencies, need training in screening, informed consent, and post-session monitoring, Smith said. "Because these models are new, we need to gather data from Colorado and Oregon to ensure safety." Facilitators generally pay a $420 training fee, which allows them to pursue the necessary consultation hours, and roughly $900 a year for a license, and healing centers pay $3,000 to $6,000 for initial licenses in Colorado. But the up-front cost for facilitators is significant: The required 150 hours in a state-accredited program and 80 hours of hands-on training can cost $10,000 or more, and Clark said she wouldn't pursue a facilitator license due to the prohibitive time and cost. To increase affordability for patients in Colorado, Poinsatte said, healing centers plan to offer sliding-scale pay options, as well as discounts for veterans, Medicaid enrollees and those with low incomes. Group sessions are another option to lower costs. Colorado law does not allow retail sales of psilocybin, unlike cannabis, which can be sold both recreationally and medically in the state. But it allows adults 21 and older to grow, use and share psychedelic mushrooms for personal use. Despite the retail ban, adjacent businesses have mushroomed. Inside the warehouse and laboratory of Activated Brands in Arvada, brown bags of sterilized grains such as corn, millet and sorghum, as well as plastic bags of soil substrate are for sale, along with genetic materials and ready-to-grow kits. Co-founder Sean Winfield sells these supplies for growing psychedelic or functional mushrooms such as lion's mane to people hoping to grow their own at home. Soon, Activated Brands will host cultivation and education classes for the public, Winfield said. Winfield and co-founder Shawn Cox recently hosted a psychedelic potluck at which experts studying and cultivating psychedelic mushrooms discussed genetics, extraction and specialized equipment. Psychedelic mushrooms have a long history in Indigenous cultures, and provisions for their use in spiritual, cultural or religious ceremonies are included in Colorado law, along with recognition of the cultural harm that could occur to federally recognized tribes and Indigenous people if natural medicine is overly commercialized or exploited. Several studies over the past five years have shown the long-term benefits of psilocybin for treatment-resistant major depressive disorder, and the Food and Drug Administration designated it a breakthrough therapy. Late-stage trials, often a precursor to application for FDA approval, are underway. Smith said psilocybin is a promising tool for treating mental health disorders but has not yet been shown to be better than other advanced treatments. Joshua Woolley, an associate professor of psychiatry and behavioral sciences at the University of California-San Francisco, said he has seen the benefits of psilocybin as an investigator in clinical trials. "People can change hard-set habits. They can become unstuck. They can see things in new ways," he said of treating patients with a combination of psilocybin and psychotherapy. Colorado, unlike Oregon, allows integration of psilocybin into existing mental health and medical practices with a clinical facilitator license, and through micro-healing centers that are more limited in the amounts of mushrooms they can store. Still, Woolley said, between the federal ban and new state laws for psychedelics, this is uncharted territory. Most drugs used to treat mental health disorders are regulated by the FDA, something that Colorado is "taking into its own hands" by setting up its own program to regulate manufacturing and administration of psilocybin. The U.S. Attorney's Office for the District of Colorado declined to comment on its policy toward state-regulated psychedelic programs or personal use provisions, but Poinsatte hopes the same federal hands-off approach to marijuana will be taken for psilocybin in Oregon and Colorado. Winfield said he looks forward to the upcoming rollout and potential addition of other plant psychedelics, such as mescaline. "We're talking about clandestine industries coming into the light," he said. The Colorado psychedelic mushroom experiment has arrived originally appeared on
