'It's Transformed My Life': FDA Approves First Gene-Editing Treatment for Illness
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This brutal blood disorder has long been neglected by medical research.\u003c/p>\n\u003cp>The decisions are being hailed as milestones for treating sickle cell and for the rapidly advancing field of gene therapy, which is stirring excitement for the treatment of many diseases.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“Sickle cell disease is a rare, debilitating and life-threatening blood disorder with significant unmet need, and we are excited to advance the field, especially for individuals whose lives have been severely disrupted by the disease by approving two cell-based gene therapies today,” says Dr. Nicole Verdun, director of the Office of Therapeutic Products within the FDA’s Center for Biologics Evaluation and Research, in a statement. “Gene therapy holds the promise of delivering more targeted and effective treatments, especially for individuals with rare diseases where the current treatment options are limited.”\u003c/p>\n\u003cp>“I’m elated, excited, in awe,” \u003ca href=\"https://vcresearch.berkeley.edu/faculty/jennifer-doudna\">Jennifer Doudna\u003c/a> of the University of California, Berkeley, who helped discover the gene-editing technique called \u003ca href=\"https://www.npr.org/series/773368439/the-crispr-revolution\">CRISPR\u003c/a> used in one of the sickle cell treatments, told NPR in an interview. “It’s an exciting day and the beginning of a new day in medicine.”\u003c/p>\n\u003cp>[pullquote align=\"right\" size=\"medium\" citation=\"Jennifer Doudna, biochemistry professor, UC Berkeley,\"]‘I’m elated, excited, in awe. It’s an exciting day and the beginning of a new day in medicine.’[/pullquote]For the CRISPR treatment, which was developed by \u003ca href=\"https://www.vrtx.com/\">Vertex Pharmaceuticals\u003c/a> and \u003ca href=\"https://crisprtx.com/\">CRISPR Therapeutics\u003c/a>, both in Boston, doctors remove cells from each patient’s bone marrow, edit a gene with CRISPR and then infuse billions of the modified cells back into patients.\u003c/p>\n\u003cp>The edited cells produce a form of hemoglobin known as fetal hemoglobin, restoring the normal function of red blood cells. While not a cure for the disease, the hope is the therapy, brand name Casgevy, is designed to be a one-time treatment that will alleviate symptoms for a lifetime.\u003c/p>\n\u003cp>In\u003ca href=\"https://www.fda.gov/media/173472/download\"> data presented to the FDA\u003c/a>, the treatment resolved the severe pain crises for at least 18 months for 29 of the subjects — 96.7%. The treatment has produced similar results for patients with a related condition known as \u003ca href=\"https://medlineplus.gov/genetics/condition/beta-thalassemia/\">beta thalassemia.\u003c/a>\u003c/p>\n\u003cp>The FDA approved another gene therapy called Lyfgenia, developed by \u003ca href=\"https://www.bluebirdbio.com/\">bluebird bio Inc\u003c/a>. of Somerville, Massachusetts, that doesn’t use CRISPR to treat sickle cell disease.\u003c/p>\n\u003ch2>Treatment comes with a high price\u003c/h2>\n\u003cp>However, the elation over the approvals was tempered by concerns the breakthrough treatments may not be accessible to many sickle cell patients.\u003c/p>\n\u003cp>They are both very expensive. Vertex says the wholesale price for Casgevy will be $2.2 million. Bluebird set the wholesale price of Lyfgenia at $3.1 million.\u003c/p>\n\u003cp>The treatments also require a complicated, arduous procedure many hospitals cannot provide. Many patients may find the treatment too physically and logistically daunting.\u003c/p>\n\u003cp>“We have a lot more work to do” to make gene-editing treatments widely available, Berkeley’s Doudna says.\u003c/p>\n\u003cp>Gene-editing, which allows scientists to manipulate the basic building blocks of life more easily than ever before, is being studied as a treatment for illnesses ranging from rare genetic disorders like muscular dystrophy to common ailments like cancer, heart disease, diabetes, AIDS and Alzheimer’s.\u003c/p>\n\u003cfigure id=\"attachment_1985712\" class=\"wp-caption alignnone\" style=\"max-width: 1024px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-1985712\" src=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2023/12/GettyImages-528038920.jpg\" alt=\"A blond white woman in a lab coat stands looking to the camera with a smile and arms crossed in a laboratory as people work behind her.\" width=\"1024\" height=\"683\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2023/12/GettyImages-528038920.jpg 1024w, https://cdn.kqed.org/wp-content/uploads/sites/35/2023/12/GettyImages-528038920-800x534.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2023/12/GettyImages-528038920-1020x680.jpg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2023/12/GettyImages-528038920-160x107.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2023/12/GettyImages-528038920-768x512.jpg 768w\" sizes=\"(max-width: 1024px) 100vw, 1024px\">\u003cfigcaption class=\"wp-caption-text\">Jennifer Doudna, who helped discover the revolutionary gene-editing tool CRISPR, photographed in the Li Ka Shing Center on the Campus of UC Berkeley on Feb. 19, 2016. \u003ccite>(Nick Otto For The Washington Post via Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Sickle cell disease is caused by a genetic defect that produces an abnormal form of the protein hemoglobin, which red blood cells need to carry oxygen through the body. As a result, the red blood cells of sickle cell patients become misshapen sickle-shaped cells that get jammed inside blood vessels. That causes excruciating, unpredictable attacks of pain and damages vital organs, cutting patients’ lives short.\u003c/p>\n\u003cp>Sickle cell disproportionately occurs among people of African, Middle Eastern and Indian descent, affecting millions around the world and about 100,000 in the U.S. Although a rare disease, sickle cell is one of the most common genetic disorders.\u003c/p>\n\u003cp>Bone marrow transplants can cure some patients, but most can’t find a suitable donor. About 20,000 patients in the U.S. have the severe form of the disease the CRISPR treatment would initially be used to treat.\u003c/p>\n\u003cp>“I’m really excited,” Dr. \u003ca href=\"https://hospital.uillinois.edu/find-a-doctor/lewis-hsu\">Lewis Hsu\u003c/a>, a pediatric hematologist at the University of Illinois at Chicago who serves as the chief medical officer at the Sickle Cell Association of America, told NPR in an interview. “This is something that we’ve been waiting for in the sickle cell community for basically 70 years. This is a very big deal.”\u003c/p>\n\u003ch2>A life transformed\u003c/h2>\n\u003cp>The approval of the CRISPR gene-editing treatment was also welcomed by\u003ca href=\"https://www.npr.org/sections/health-shots/2019/12/25/784395525/a-young-mississippi-womans-journey-through-a-pioneering-gene-editing-experiment\"> Victoria Gray\u003c/a>, a Forest, Mississippi, sickle cell patient who was the first person to receive it in the U.S. NPR has had exclusive access to chronicle her experience since she was treated in 2019.\u003c/p>\n\u003cp>[pullquote align=\"right\" size=\"medium\" citation=\"Victoria Gray, sickle cell patient\"]‘Since I received the CRISPR treatment, I’ve had a new beginning. Most of all, I no longer have to fear dying and leaving my kids behind without a mother. My life is limitless now. I’m full of energy. I don’t have pain. It’s a real transformation.’[/pullquote]“I’m ecstatic. It’s a blessing that they approved this therapy. It’s a new beginning for people with sickle cell disease,” Gray told NPR in her latest interview with NPR.\u003c/p>\n\u003cp>Like many sickle cell patients, Gray was forced throughout her life to repeatedly rush to the hospital for powerful pain drugs and blood transfusions. She could not finish school, hold jobs or often even care for herself or her children.\u003c/p>\n\u003cp>“This has turned my life around. It gave me a new lease on life. It’s transformed my life more than I could have ever imagined,” Gray says.\u003c/p>\n\u003cp>Since the treatment, Gray has been much more energetic and able to start working full-time selling cosmetics at Walmart and spend more time with her four children, who are now teenagers.\u003c/p>\n\u003cp>“Since I received the CRISPR treatment, I’ve had a new beginning. Most of all, I no longer have to fear dying and leaving my kids behind without a mother,” Gray says. “My life is limitless now. I’m full of energy. I don’t have pain. It’s a real transformation.”\u003c/p>\n\u003ch2>Technical complexity and lengthy hospitalization\u003c/h2>\n\u003cp>Aside from the price of the treatments, another concern is the procedures are long, difficult and complex, requiring multiple trips to a hospital for testing, a grueling and potentially dangerous bone marrow transplant, and lengthy hospitalization. Those factors may put the treatment out of reach for those who need it most in the U.S., as well as in less affluent countries where the disease is most common.\u003c/p>\n\u003cp>[pullquote align=\"right\" size=\"medium\" citation=\"Melissa Creary, assistant professor, University of Michigan School of Public Health\"]‘I have a mixed reaction. … as this technology comes to market, it’s going to be really interesting to see the ways in which profit overtakes social justice.’[/pullquote]“I have a mixed reaction,” says \u003ca href=\"https://sph.umich.edu/faculty-profiles/creary-melissa.html\">Melissa Creary\u003c/a>, an assistant professor at the University of Michigan who studies sickle cell at the University of Michigan School of Public Health and has the disease herself. “I am excited about the promise that this technology has for those living with sickle cell disease. But as this technology comes to market, it’s going to be really interesting to see the ways in which profit overtakes social justice.”\u003c/p>\n\u003cp>Many of the countries where most sickle cell patients live don’t have enough sophisticated medical centers to provide complicated treatment. Even in the U.S., the treatment may not be widely available, making it difficult to access.\u003c/p>\n\u003cp>“Rural patients will likely to be at a disadvantage. And there might be whole states or regions with no gene-therapy options,” Hsu says.\u003c/p>\n\u003ch2>More gene-editing treatments are in the works\u003c/h2>\n\u003cp>Doudna heads a center at Berkeley to try to make gene-editing treatments simpler and, therefore, more accessible. The National Institutes of Health is also trying to address the problem.\u003c/p>\n\u003cp>The biotech companies say they are working with private and public insurers to cover the procedure. Advocates note that the high price could easily be offset by the savings of avoiding a lifetime of sickle cell complications.\u003c/p>\n\u003cp>Another concern is whether sufficient research had been done to spot “off-target” effects of the treatment — unintended editing errors that missed their mark in the DNA and that could potentially cause long-term health problems.\u003c/p>\n\u003cp>The companies plan to follow all the patients treated in the study for 15 years to see how long the benefits last, if the treatment actually helps patients live longer, and watch for any signs of long-term complications.\u003c/p>\n\u003cp>CRISPR-based treatments have also shown promise for treating a rare liver condition known as amyloidosis, as well as an inherited form of high cholesterol known as familial hypercholesterolemia.\u003c/p>\n\u003cp>“It’s only the beginning,” CRISPR researcher Doudna says.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n","blocks":[],"excerpt":"The FDA approved two gene therapies for anyone 12 and older suffering from the most severe form of sickle cell disease, a brutal blood disorder long neglected by medical research.","status":"publish","parent":0,"modified":1704845806,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":36,"wordCount":1627},"headData":{"title":"'It's Transformed My Life': FDA Approves First Gene-Editing Treatment for Illness | KQED","description":"The FDA approved two gene therapies for anyone 12 and older suffering from the most severe form of sickle cell disease, a brutal blood disorder long neglected by medical research.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"'It's Transformed My Life': FDA Approves First Gene-Editing Treatment for Illness","datePublished":"2023-12-09T12:00:33.000Z","dateModified":"2024-01-10T00:16:46.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"source":"NPR","sourceUrl":"https://www.kqed.org/arts/affiliate/npr","sticky":false,"nprByline":"\u003ca href=\"https://www.npr.org/people/146944972/rob-stein\">Rob Stein\u003c/a>","excludeFromSiteSearch":"Include","showOnAuthorArchivePages":"No","articleAge":"0","path":"/science/1985709/fda-approves-first-gene-editing-treatment-for-human-illness","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>In a landmark decision, the Food and Drug Administration on Friday approved the first gene-editing treatment to alleviate human illness.\u003c/p>\n\u003cp>The FDA approved two gene therapies for anyone 12 and older suffering from the most severe form of \u003ca href=\"https://www.nhlbi.nih.gov/health/sickle-cell-disease\">sickle cell disease\u003c/a>. This brutal blood disorder has long been neglected by medical research.\u003c/p>\n\u003cp>The decisions are being hailed as milestones for treating sickle cell and for the rapidly advancing field of gene therapy, which is stirring excitement for the treatment of many diseases.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“Sickle cell disease is a rare, debilitating and life-threatening blood disorder with significant unmet need, and we are excited to advance the field, especially for individuals whose lives have been severely disrupted by the disease by approving two cell-based gene therapies today,” says Dr. Nicole Verdun, director of the Office of Therapeutic Products within the FDA’s Center for Biologics Evaluation and Research, in a statement. “Gene therapy holds the promise of delivering more targeted and effective treatments, especially for individuals with rare diseases where the current treatment options are limited.”\u003c/p>\n\u003cp>“I’m elated, excited, in awe,” \u003ca href=\"https://vcresearch.berkeley.edu/faculty/jennifer-doudna\">Jennifer Doudna\u003c/a> of the University of California, Berkeley, who helped discover the gene-editing technique called \u003ca href=\"https://www.npr.org/series/773368439/the-crispr-revolution\">CRISPR\u003c/a> used in one of the sickle cell treatments, told NPR in an interview. “It’s an exciting day and the beginning of a new day in medicine.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"‘I’m elated, excited, in awe. It’s an exciting day and the beginning of a new day in medicine.’","name":"pullquote","attributes":{"named":{"align":"right","size":"medium","citation":"Jennifer Doudna, biochemistry professor, UC Berkeley,","label":""},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>For the CRISPR treatment, which was developed by \u003ca href=\"https://www.vrtx.com/\">Vertex Pharmaceuticals\u003c/a> and \u003ca href=\"https://crisprtx.com/\">CRISPR Therapeutics\u003c/a>, both in Boston, doctors remove cells from each patient’s bone marrow, edit a gene with CRISPR and then infuse billions of the modified cells back into patients.\u003c/p>\n\u003cp>The edited cells produce a form of hemoglobin known as fetal hemoglobin, restoring the normal function of red blood cells. While not a cure for the disease, the hope is the therapy, brand name Casgevy, is designed to be a one-time treatment that will alleviate symptoms for a lifetime.\u003c/p>\n\u003cp>In\u003ca href=\"https://www.fda.gov/media/173472/download\"> data presented to the FDA\u003c/a>, the treatment resolved the severe pain crises for at least 18 months for 29 of the subjects — 96.7%. The treatment has produced similar results for patients with a related condition known as \u003ca href=\"https://medlineplus.gov/genetics/condition/beta-thalassemia/\">beta thalassemia.\u003c/a>\u003c/p>\n\u003cp>The FDA approved another gene therapy called Lyfgenia, developed by \u003ca href=\"https://www.bluebirdbio.com/\">bluebird bio Inc\u003c/a>. of Somerville, Massachusetts, that doesn’t use CRISPR to treat sickle cell disease.\u003c/p>\n\u003ch2>Treatment comes with a high price\u003c/h2>\n\u003cp>However, the elation over the approvals was tempered by concerns the breakthrough treatments may not be accessible to many sickle cell patients.\u003c/p>\n\u003cp>They are both very expensive. Vertex says the wholesale price for Casgevy will be $2.2 million. Bluebird set the wholesale price of Lyfgenia at $3.1 million.\u003c/p>\n\u003cp>The treatments also require a complicated, arduous procedure many hospitals cannot provide. Many patients may find the treatment too physically and logistically daunting.\u003c/p>\n\u003cp>“We have a lot more work to do” to make gene-editing treatments widely available, Berkeley’s Doudna says.\u003c/p>\n\u003cp>Gene-editing, which allows scientists to manipulate the basic building blocks of life more easily than ever before, is being studied as a treatment for illnesses ranging from rare genetic disorders like muscular dystrophy to common ailments like cancer, heart disease, diabetes, AIDS and Alzheimer’s.\u003c/p>\n\u003cfigure id=\"attachment_1985712\" class=\"wp-caption alignnone\" style=\"max-width: 1024px\">\u003cimg loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-1985712\" src=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2023/12/GettyImages-528038920.jpg\" alt=\"A blond white woman in a lab coat stands looking to the camera with a smile and arms crossed in a laboratory as people work behind her.\" width=\"1024\" height=\"683\" srcset=\"https://cdn.kqed.org/wp-content/uploads/sites/35/2023/12/GettyImages-528038920.jpg 1024w, https://cdn.kqed.org/wp-content/uploads/sites/35/2023/12/GettyImages-528038920-800x534.jpg 800w, https://cdn.kqed.org/wp-content/uploads/sites/35/2023/12/GettyImages-528038920-1020x680.jpg 1020w, https://cdn.kqed.org/wp-content/uploads/sites/35/2023/12/GettyImages-528038920-160x107.jpg 160w, https://cdn.kqed.org/wp-content/uploads/sites/35/2023/12/GettyImages-528038920-768x512.jpg 768w\" sizes=\"(max-width: 1024px) 100vw, 1024px\">\u003cfigcaption class=\"wp-caption-text\">Jennifer Doudna, who helped discover the revolutionary gene-editing tool CRISPR, photographed in the Li Ka Shing Center on the Campus of UC Berkeley on Feb. 19, 2016. \u003ccite>(Nick Otto For The Washington Post via Getty Images)\u003c/cite>\u003c/figcaption>\u003c/figure>\n\u003cp>Sickle cell disease is caused by a genetic defect that produces an abnormal form of the protein hemoglobin, which red blood cells need to carry oxygen through the body. As a result, the red blood cells of sickle cell patients become misshapen sickle-shaped cells that get jammed inside blood vessels. That causes excruciating, unpredictable attacks of pain and damages vital organs, cutting patients’ lives short.\u003c/p>\n\u003cp>Sickle cell disproportionately occurs among people of African, Middle Eastern and Indian descent, affecting millions around the world and about 100,000 in the U.S. Although a rare disease, sickle cell is one of the most common genetic disorders.\u003c/p>\n\u003cp>Bone marrow transplants can cure some patients, but most can’t find a suitable donor. About 20,000 patients in the U.S. have the severe form of the disease the CRISPR treatment would initially be used to treat.\u003c/p>\n\u003cp>“I’m really excited,” Dr. \u003ca href=\"https://hospital.uillinois.edu/find-a-doctor/lewis-hsu\">Lewis Hsu\u003c/a>, a pediatric hematologist at the University of Illinois at Chicago who serves as the chief medical officer at the Sickle Cell Association of America, told NPR in an interview. “This is something that we’ve been waiting for in the sickle cell community for basically 70 years. This is a very big deal.”\u003c/p>\n\u003ch2>A life transformed\u003c/h2>\n\u003cp>The approval of the CRISPR gene-editing treatment was also welcomed by\u003ca href=\"https://www.npr.org/sections/health-shots/2019/12/25/784395525/a-young-mississippi-womans-journey-through-a-pioneering-gene-editing-experiment\"> Victoria Gray\u003c/a>, a Forest, Mississippi, sickle cell patient who was the first person to receive it in the U.S. NPR has had exclusive access to chronicle her experience since she was treated in 2019.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"‘Since I received the CRISPR treatment, I’ve had a new beginning. Most of all, I no longer have to fear dying and leaving my kids behind without a mother. My life is limitless now. I’m full of energy. I don’t have pain. It’s a real transformation.’","name":"pullquote","attributes":{"named":{"align":"right","size":"medium","citation":"Victoria Gray, sickle cell patient","label":""},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>“I’m ecstatic. It’s a blessing that they approved this therapy. It’s a new beginning for people with sickle cell disease,” Gray told NPR in her latest interview with NPR.\u003c/p>\n\u003cp>Like many sickle cell patients, Gray was forced throughout her life to repeatedly rush to the hospital for powerful pain drugs and blood transfusions. She could not finish school, hold jobs or often even care for herself or her children.\u003c/p>\n\u003cp>“This has turned my life around. It gave me a new lease on life. It’s transformed my life more than I could have ever imagined,” Gray says.\u003c/p>\n\u003cp>Since the treatment, Gray has been much more energetic and able to start working full-time selling cosmetics at Walmart and spend more time with her four children, who are now teenagers.\u003c/p>\n\u003cp>“Since I received the CRISPR treatment, I’ve had a new beginning. Most of all, I no longer have to fear dying and leaving my kids behind without a mother,” Gray says. “My life is limitless now. I’m full of energy. I don’t have pain. It’s a real transformation.”\u003c/p>\n\u003ch2>Technical complexity and lengthy hospitalization\u003c/h2>\n\u003cp>Aside from the price of the treatments, another concern is the procedures are long, difficult and complex, requiring multiple trips to a hospital for testing, a grueling and potentially dangerous bone marrow transplant, and lengthy hospitalization. Those factors may put the treatment out of reach for those who need it most in the U.S., as well as in less affluent countries where the disease is most common.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"‘I have a mixed reaction. … as this technology comes to market, it’s going to be really interesting to see the ways in which profit overtakes social justice.’","name":"pullquote","attributes":{"named":{"align":"right","size":"medium","citation":"Melissa Creary, assistant professor, University of Michigan School of Public Health","label":""},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>“I have a mixed reaction,” says \u003ca href=\"https://sph.umich.edu/faculty-profiles/creary-melissa.html\">Melissa Creary\u003c/a>, an assistant professor at the University of Michigan who studies sickle cell at the University of Michigan School of Public Health and has the disease herself. “I am excited about the promise that this technology has for those living with sickle cell disease. But as this technology comes to market, it’s going to be really interesting to see the ways in which profit overtakes social justice.”\u003c/p>\n\u003cp>Many of the countries where most sickle cell patients live don’t have enough sophisticated medical centers to provide complicated treatment. Even in the U.S., the treatment may not be widely available, making it difficult to access.\u003c/p>\n\u003cp>“Rural patients will likely to be at a disadvantage. And there might be whole states or regions with no gene-therapy options,” Hsu says.\u003c/p>\n\u003ch2>More gene-editing treatments are in the works\u003c/h2>\n\u003cp>Doudna heads a center at Berkeley to try to make gene-editing treatments simpler and, therefore, more accessible. The National Institutes of Health is also trying to address the problem.\u003c/p>\n\u003cp>The biotech companies say they are working with private and public insurers to cover the procedure. Advocates note that the high price could easily be offset by the savings of avoiding a lifetime of sickle cell complications.\u003c/p>\n\u003cp>Another concern is whether sufficient research had been done to spot “off-target” effects of the treatment — unintended editing errors that missed their mark in the DNA and that could potentially cause long-term health problems.\u003c/p>\n\u003cp>The companies plan to follow all the patients treated in the study for 15 years to see how long the benefits last, if the treatment actually helps patients live longer, and watch for any signs of long-term complications.\u003c/p>\n\u003cp>CRISPR-based treatments have also shown promise for treating a rare liver condition known as amyloidosis, as well as an inherited form of high cholesterol known as familial hypercholesterolemia.\u003c/p>\n\u003cp>“It’s only the beginning,” CRISPR researcher Doudna says.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/science/1985709/fda-approves-first-gene-editing-treatment-for-human-illness","authors":["byline_science_1985709"],"categories":["science_39","science_3890","science_40","science_4450"],"tags":["science_1287","science_1050","science_4417","science_4414","science_327","science_190"],"featImg":"science_1985711","label":"source_science_1985709"},"science_1984081":{"type":"posts","id":"science_1984081","meta":{"index":"posts_1591205157","site":"science","id":"1984081","score":null,"sort":[1692990057000]},"guestAuthors":[],"slug":"covid-19-a-disease-with-tricks-up-its-sleeve-hasnt-fallen-into-a-seasonal-pattern-yet","title":"COVID-19, a Disease With Tricks Up Its Sleeve, Hasn’t Fallen Into a Seasonal Pattern — Yet","publishDate":1692990057,"format":"standard","headTitle":"COVID-19, a Disease With Tricks Up Its Sleeve, Hasn’t Fallen Into a Seasonal Pattern — Yet | KQED","labelTerm":{},"content":"\u003cp>To most people on the planet, the COVID-19 pandemic is over. But for many scientists who have been tracking the largest global infectious disease event in the era of molecular biology, there is still a step that the virus that caused it, SARS-CoV-2, hasn’t yet taken. It has not fallen into a predictable seasonal pattern of the type most respiratory pathogens follow.\u003c/p>\n\u003cp>Influenza strikes — at least in temperate climates — in the winter months, with activity often peaking in January or February. In the pre-COVID times, that was also true for RSV — respiratory syncytial virus — and a number of other bugs that inflict cold- and flu-like illnesses. Some respiratory pathogens seem to prefer fall or spring. Even measles, when that disease circulated widely, had a seasonality in our part of the world, typically striking in late winter or early spring.\u003c/p>\n\u003cp>To be sure, you can contract these viruses at any time of the year. But transmission takes off during a particular pathogen’s season. (The COVID pandemic knocked a number of these bugs \u003ca href=\"https://www.statnews.com/2022/05/25/viruses-that-were-on-hiatus-during-covid-are-back-and-behaving-in-unexpected-ways/\">out of their regular orbits\u003c/a>, though they may be heading back to more normal transmission patterns. The next few months should be telling.)\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>It’s been widely expected that SARS-2 will ease into that type of a transmission pattern, once human immune systems and the virus reach a sort of detente. But most experts STAT spoke to about this question said that, so far, the virus has not obliged. Their views differ on the margins. Some expect seasonality to set in soon while others don’t venture to guess when the virus will settle into a seasonal pattern.\u003c/p>\n\u003cp>“I don’t see clear seasonality for SARS-CoV-2 yet,” Kanta Subbarao, director of the World Health Organization’s Collaborating Centre for Reference and Research on Influenza at the Peter Doherty Institute for Infection and Immunity in Melbourne, Australia, said via email. Subbarao is also chair of the WHO’s technical advisory group on COVID-19 vaccine composition, an independent panel that recommends which version or versions of SARS-2 should be included in updated COVID vaccines.\u003c/p>\n\u003cp>Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, agreed. “There just isn’t a definable pattern yet that would call this a seasonal virus. That’s not to suggest it might not be some day.”[pullquote align=\"right\" size=\"medium\" citation=\"Ben Cowling, infectious diseases epidemiologist, University of Hong Kong\"]‘At the moment I don’t think COVID is predictable but it is showing all the signs of becoming the fifth ‘human coronavirus’ along with OC43, NL63, 229E and HKU1.’[/pullquote]Maria Van Kerkhove, the WHO’s technical lead for COVID, told STAT in a recent interview that the lack of seasonality is clear. “We expect there to be some seasonality in the coming years. Just based on people’s behavior, perhaps, just because it’s respiratory,” she said. Van Kerkhove does, though, think there are hints of a transmission pattern that is coming into view, something she and others refer to as “periodicity.”\u003c/p>\n\u003cp>“If you kind of squint, you could see a little, you know, in different places,” Van Kerkhove said. “I think you can see sort of waves of infection every five, six months or so depending on the population. But that isn’t at a national level. … And it’s not hemispheric.”\u003c/p>\n\u003cp>Questions posed over SARS-2’s lack of seasonality aren’t purely academic. Knowing when to expect a disease is critical for health care labor force planning. The tsunami of RSV-infected babies struggling to breathe in the late summer and early fall of 2022 was made worse by the fact that hospitals weren’t as prepared as they could have been; they normally see RSV peaks in the winter months. Likewise, knowing when to expect SARS-2 surges helps the Food and Drug Administration and the Centers for Disease Control and Prevention time the rollout of COVID booster shots. The protection against infection generated by the vaccines wanes quickly, so giving them too soon or too late would undermine the efficacy of this countermeasure.\u003c/p>\n\u003cp>Van Kerkhove thinks waning immunity in the population is the reason for the periodic swells of transmission. Protection against severe disease — whether induced by infection, vaccination, or the two combined — appears to hold up reasonably well. But when it comes to SARS-2, protection against basic infection is short-lived. That’s not a surprise given what’s known about the four human coronaviruses that predate the arrival of SARS-2. A study in the Netherlands that followed healthy volunteers for more than 35 years found that people can be reinfected with human coronaviruses within about a year after infection, and sometimes after a mere six months. With SARS-2, there are reports of intervals that are shorter still.\u003c/p>\n\u003cp>Michael Mina, an infectious diseases epidemiologist who previously taught at the Harvard School of Public Health, is a bit of an outlier in this conversation. He believes SARS-2 has been displaying seasonal behavior for a while, though what he describes sounds like the periodicity that Van Kerkhove and some other experts speak of.\u003c/p>\n\u003cp>Mina thinks of seasonality in terms of predictability, “that certain periods of time are going to see increases and decreases, but not necessarily that it has to just be winter or summer.”\u003c/p>\n\u003cp>“I don’t think I use the word wrong but I don’t think it’s well defined one way or the other,” he noted.[aside label=\"Related Stories\" postID=\"news_11957790,news_11954507,forum_2010101894165\"]Ben Cowling, an infectious diseases epidemiologist at the University of Hong Kong, also thinks seasonality and predictability are intertwined. He doesn’t think SARS-2 is there yet — but believes it’s on its way.\u003c/p>\n\u003cp>“At the moment I don’t think COVID is predictable but it is showing all the signs of becoming the fifth ‘human coronavirus’ along with OC43, NL63, 229E and HKU1,” he said in an email, ticking off the names of the four human coronaviruses that predated SARS-2.\u003c/p>\n\u003cp>Osterholm doesn’t agree, arguing that even if they follow a pattern, swells of COVID cases at different points in a year doesn’t equate to seasonality. Furthermore, he noted that the patterns we’ve seen to date have been largely tied to the emergence of new variants, like Beta, Delta, and Omicron, with large surges of infections when those versions of SARS-2 arrived in the spring, summer, and late autumn of 2021 respectively.\u003c/p>\n\u003cp>“It wasn’t tied to some kind of environmental conditions. And that’s what you often think of with seasonality,” Osterholm said.\u003c/p>\n\u003cp>It’s thought that with new viruses, the vast number of susceptible people allows a virus to override conditions that would constrain more established pathogens — kids being out of school, unfavorable atmospheric conditions — and transmit at a time when it normally should not be able to. Epidemiologists refer to this override capacity as the “force of infection.”\u003c/p>\n\u003cp>That, in turn, can impact the ability of other pathogens to transmit during their accustomed times, as was the case with COVID’s disruption of flu and RSV. “When a virus is in a pandemic mode, there are forces occurring that we just don’t understand,” Osterholm said.\u003c/p>\n\u003cp>There are a number of theories about why some viruses hew to a seasonal pattern. It’s thought an interplay of factors is at work. Some have been mapped out, others remain in the realm of the unexplained.\u003c/p>\n\u003cp>Some relate to human activities, like school, that bring together lots of children, who are \u003ca href=\"https://www.statnews.com/2020/02/27/coronavirus-kids-what-role-transmission/\">expert at amplifying\u003c/a> respiratory pathogens. Or holiday travel, potentially. Marion Koopmans, head of virology at Erasmus Medical Center in Rotterdam, the Netherlands, noted that \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8324533/\">a study\u003c/a> published in Nature suggested that a surge in Covid cases in the summer of 2020 in Europe was likely due to people vacationing. “Without detailed analysis, I do not think we can rule out that what we see is ‘holiday traffic,’” Koopmans said, referring to the upticks of cases that have been reported every Northern Hemisphere summer since 2020.\u003c/p>\n\u003cp>Environmental factors are also thought to be at play. The lack of humidity in the air in cold winters affects the integrity of mucus membranes, and it allows viruses to \u003ca href=\"https://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1003194\">survive better\u003c/a> outside a human host. People in temperate climates crowd together indoors during the winter, often in settings where air quality is suboptimal. Interestingly, the defined flu seasons that the Northern and Southern Hemispheres experience are not observed in tropical climates, where transmission occurs on a more \u003ca href=\"https://www.embopress.org/doi/full/10.15252/emmm.202115352\">year-round basis\u003c/a>, without the sharp peaks seen in temperate zones.\u003c/p>\n\u003cp>“There is now a much stronger evidence base on the impact of climate variables (esp. temperature, humidity) on pathogen survival and how this translates to an impact on transmission in the population,” Nick Grassly, an infectious diseases modeler at the school of public health at Imperial College London, said in an email. “The focus has been much more on environmental drivers (particularly humidity, temperature, rainfall, etc.) than human behavior.”\u003c/p>\n\u003cp>Grassly is one of the people who thinks SARS-2 seasonality is falling into place, noting that the Joint Committee on Vaccination and Immunisation — Britain’s equivalent of the Advisory Committee on Immunization Practices, an expert committee that helps the CDC craft vaccination use guidelines — is now recommending a targeted \u003ca href=\"https://www.gov.uk/government/news/jcvi-advises-an-autumn-covid-19-vaccine-booster\">autumn COVID vaccination campaign\u003c/a> for high-risk individuals, in anticipation of a surge of COVID activity this winter. A similar, though more broadly aimed campaign is planned for the United States.\u003c/p>\n\u003cp>“It remains possible that a new variant showing substantial immune escape could spread rapidly, even in summer, and so disrupt seasonal patterns and planning,” Grassly noted. “I think it is hard to estimate the probability that this happens, but it would deviate from the recent pattern of successive Omicron variants which have emerged without large increases in overall incidence.”\u003c/p>\n\u003cp>Stanley Perlman, a coronavirus expert whose bona fides in the field stretch back to the pre-SARS-1 days, agrees with Grassly.[pullquote align=\"right\" size=\"medium\" citation=\"Marion Koopmans, head of virology, Erasmus Medical Center\"]‘I think that — at this stage — all we can say is that we can assume that there are some seasonal effects … but that we really cannot say the circulation of these viruses is predictable yet, at least not like we have come to know for flu.’[/pullquote]“I think for all these viruses” — human coronaviruses — “they probably circulate all year round. But you get large numbers of infections in the late fall, winter, when people are inside, and they spread. That’s what this virus seems to be doing,” said Perlman, a professor of microbiology and immunology at the University of Iowa. “As opposed to last summer, the number of cases is way down this summer. And the prediction is they will increase in the late fall, winter again.”\u003c/p>\n\u003cp>A break from seasonal transmission of respiratory pathogens can be a sign something is amiss, with off-season spread having been observed during flu pandemics going back to the Spanish flu pandemic of 1918. The first observed cases in that pandemic occurred in the spring, at a time when flu season would normally have concluded. The 1957 pandemic began in Asia in February of that year, but the virus arrived in, and started spreading through, the United States, during the summer. The 1968 pandemic began in July. The 2009 H1N1 pandemic was first detected in April and the pandemic’s major wave ran through the summer, peaked in September and trailed off in October.\u003c/p>\n\u003cp>“Pandemic influenza doesn’t follow a seasonal pattern in any way, shape or form,” said Osterholm.\u003c/p>\n\u003cp>It remains to be seen when it will be apparent that SARS-2 has lost its override capabilities, when we’ll feel confident that we know when to expect — plus or minus a month or two — COVID’s annual onslaught.\u003c/p>\n\u003cp>“I think that — at this stage — all we can say is that we can assume that there are some seasonal effects (since we know seasonality does have an effect on other respiratory infections, both by effects on virus stability and on the host) but that we really cannot say the circulation of these viruses is predictable yet, at least not like we have come to know for flu,” Koopmans wrote.\u003c/p>\n\u003cp>\u003cem>This story was originally published by \u003ca href=\"https://www.statnews.com/\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n","blocks":[],"excerpt":"SARS-CoV-2 has not yet fallen into a predictable seasonal pattern of the type most respiratory pathogens follow, experts say.","status":"publish","parent":0,"modified":1704845916,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":31,"wordCount":2199},"headData":{"title":"COVID-19, a Disease With Tricks Up Its Sleeve, Hasn’t Fallen Into a Seasonal Pattern — Yet | KQED","description":"SARS-CoV-2 has not yet fallen into a predictable seasonal pattern of the type most respiratory pathogens follow, experts say.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"COVID-19, a Disease With Tricks Up Its Sleeve, Hasn’t Fallen Into a Seasonal Pattern — Yet","datePublished":"2023-08-25T19:00:57.000Z","dateModified":"2024-01-10T00:18:36.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"source":"STAT","sourceUrl":"https://www.statnews.com/","sticky":false,"nprByline":"\u003ca href=\"https://www.statnews.com/staff/helen-branswell/\">Helen Branswell\u003c/a>","excludeFromSiteSearch":"Include","showOnAuthorArchivePages":"No","articleAge":"0","path":"/science/1984081/covid-19-a-disease-with-tricks-up-its-sleeve-hasnt-fallen-into-a-seasonal-pattern-yet","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>To most people on the planet, the COVID-19 pandemic is over. But for many scientists who have been tracking the largest global infectious disease event in the era of molecular biology, there is still a step that the virus that caused it, SARS-CoV-2, hasn’t yet taken. It has not fallen into a predictable seasonal pattern of the type most respiratory pathogens follow.\u003c/p>\n\u003cp>Influenza strikes — at least in temperate climates — in the winter months, with activity often peaking in January or February. In the pre-COVID times, that was also true for RSV — respiratory syncytial virus — and a number of other bugs that inflict cold- and flu-like illnesses. Some respiratory pathogens seem to prefer fall or spring. Even measles, when that disease circulated widely, had a seasonality in our part of the world, typically striking in late winter or early spring.\u003c/p>\n\u003cp>To be sure, you can contract these viruses at any time of the year. But transmission takes off during a particular pathogen’s season. (The COVID pandemic knocked a number of these bugs \u003ca href=\"https://www.statnews.com/2022/05/25/viruses-that-were-on-hiatus-during-covid-are-back-and-behaving-in-unexpected-ways/\">out of their regular orbits\u003c/a>, though they may be heading back to more normal transmission patterns. The next few months should be telling.)\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>It’s been widely expected that SARS-2 will ease into that type of a transmission pattern, once human immune systems and the virus reach a sort of detente. But most experts STAT spoke to about this question said that, so far, the virus has not obliged. Their views differ on the margins. Some expect seasonality to set in soon while others don’t venture to guess when the virus will settle into a seasonal pattern.\u003c/p>\n\u003cp>“I don’t see clear seasonality for SARS-CoV-2 yet,” Kanta Subbarao, director of the World Health Organization’s Collaborating Centre for Reference and Research on Influenza at the Peter Doherty Institute for Infection and Immunity in Melbourne, Australia, said via email. Subbarao is also chair of the WHO’s technical advisory group on COVID-19 vaccine composition, an independent panel that recommends which version or versions of SARS-2 should be included in updated COVID vaccines.\u003c/p>\n\u003cp>Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, agreed. “There just isn’t a definable pattern yet that would call this a seasonal virus. That’s not to suggest it might not be some day.”\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"‘At the moment I don’t think COVID is predictable but it is showing all the signs of becoming the fifth ‘human coronavirus’ along with OC43, NL63, 229E and HKU1.’","name":"pullquote","attributes":{"named":{"align":"right","size":"medium","citation":"Ben Cowling, infectious diseases epidemiologist, University of Hong Kong","label":""},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>Maria Van Kerkhove, the WHO’s technical lead for COVID, told STAT in a recent interview that the lack of seasonality is clear. “We expect there to be some seasonality in the coming years. Just based on people’s behavior, perhaps, just because it’s respiratory,” she said. Van Kerkhove does, though, think there are hints of a transmission pattern that is coming into view, something she and others refer to as “periodicity.”\u003c/p>\n\u003cp>“If you kind of squint, you could see a little, you know, in different places,” Van Kerkhove said. “I think you can see sort of waves of infection every five, six months or so depending on the population. But that isn’t at a national level. … And it’s not hemispheric.”\u003c/p>\n\u003cp>Questions posed over SARS-2’s lack of seasonality aren’t purely academic. Knowing when to expect a disease is critical for health care labor force planning. The tsunami of RSV-infected babies struggling to breathe in the late summer and early fall of 2022 was made worse by the fact that hospitals weren’t as prepared as they could have been; they normally see RSV peaks in the winter months. Likewise, knowing when to expect SARS-2 surges helps the Food and Drug Administration and the Centers for Disease Control and Prevention time the rollout of COVID booster shots. The protection against infection generated by the vaccines wanes quickly, so giving them too soon or too late would undermine the efficacy of this countermeasure.\u003c/p>\n\u003cp>Van Kerkhove thinks waning immunity in the population is the reason for the periodic swells of transmission. Protection against severe disease — whether induced by infection, vaccination, or the two combined — appears to hold up reasonably well. But when it comes to SARS-2, protection against basic infection is short-lived. That’s not a surprise given what’s known about the four human coronaviruses that predate the arrival of SARS-2. A study in the Netherlands that followed healthy volunteers for more than 35 years found that people can be reinfected with human coronaviruses within about a year after infection, and sometimes after a mere six months. With SARS-2, there are reports of intervals that are shorter still.\u003c/p>\n\u003cp>Michael Mina, an infectious diseases epidemiologist who previously taught at the Harvard School of Public Health, is a bit of an outlier in this conversation. He believes SARS-2 has been displaying seasonal behavior for a while, though what he describes sounds like the periodicity that Van Kerkhove and some other experts speak of.\u003c/p>\n\u003cp>Mina thinks of seasonality in terms of predictability, “that certain periods of time are going to see increases and decreases, but not necessarily that it has to just be winter or summer.”\u003c/p>\n\u003cp>“I don’t think I use the word wrong but I don’t think it’s well defined one way or the other,” he noted.\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"aside","attributes":{"named":{"label":"Related Stories ","postid":"news_11957790,news_11954507,forum_2010101894165"},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>Ben Cowling, an infectious diseases epidemiologist at the University of Hong Kong, also thinks seasonality and predictability are intertwined. He doesn’t think SARS-2 is there yet — but believes it’s on its way.\u003c/p>\n\u003cp>“At the moment I don’t think COVID is predictable but it is showing all the signs of becoming the fifth ‘human coronavirus’ along with OC43, NL63, 229E and HKU1,” he said in an email, ticking off the names of the four human coronaviruses that predated SARS-2.\u003c/p>\n\u003cp>Osterholm doesn’t agree, arguing that even if they follow a pattern, swells of COVID cases at different points in a year doesn’t equate to seasonality. Furthermore, he noted that the patterns we’ve seen to date have been largely tied to the emergence of new variants, like Beta, Delta, and Omicron, with large surges of infections when those versions of SARS-2 arrived in the spring, summer, and late autumn of 2021 respectively.\u003c/p>\n\u003cp>“It wasn’t tied to some kind of environmental conditions. And that’s what you often think of with seasonality,” Osterholm said.\u003c/p>\n\u003cp>It’s thought that with new viruses, the vast number of susceptible people allows a virus to override conditions that would constrain more established pathogens — kids being out of school, unfavorable atmospheric conditions — and transmit at a time when it normally should not be able to. Epidemiologists refer to this override capacity as the “force of infection.”\u003c/p>\n\u003cp>That, in turn, can impact the ability of other pathogens to transmit during their accustomed times, as was the case with COVID’s disruption of flu and RSV. “When a virus is in a pandemic mode, there are forces occurring that we just don’t understand,” Osterholm said.\u003c/p>\n\u003cp>There are a number of theories about why some viruses hew to a seasonal pattern. It’s thought an interplay of factors is at work. Some have been mapped out, others remain in the realm of the unexplained.\u003c/p>\n\u003cp>Some relate to human activities, like school, that bring together lots of children, who are \u003ca href=\"https://www.statnews.com/2020/02/27/coronavirus-kids-what-role-transmission/\">expert at amplifying\u003c/a> respiratory pathogens. Or holiday travel, potentially. Marion Koopmans, head of virology at Erasmus Medical Center in Rotterdam, the Netherlands, noted that \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8324533/\">a study\u003c/a> published in Nature suggested that a surge in Covid cases in the summer of 2020 in Europe was likely due to people vacationing. “Without detailed analysis, I do not think we can rule out that what we see is ‘holiday traffic,’” Koopmans said, referring to the upticks of cases that have been reported every Northern Hemisphere summer since 2020.\u003c/p>\n\u003cp>Environmental factors are also thought to be at play. The lack of humidity in the air in cold winters affects the integrity of mucus membranes, and it allows viruses to \u003ca href=\"https://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1003194\">survive better\u003c/a> outside a human host. People in temperate climates crowd together indoors during the winter, often in settings where air quality is suboptimal. Interestingly, the defined flu seasons that the Northern and Southern Hemispheres experience are not observed in tropical climates, where transmission occurs on a more \u003ca href=\"https://www.embopress.org/doi/full/10.15252/emmm.202115352\">year-round basis\u003c/a>, without the sharp peaks seen in temperate zones.\u003c/p>\n\u003cp>“There is now a much stronger evidence base on the impact of climate variables (esp. temperature, humidity) on pathogen survival and how this translates to an impact on transmission in the population,” Nick Grassly, an infectious diseases modeler at the school of public health at Imperial College London, said in an email. “The focus has been much more on environmental drivers (particularly humidity, temperature, rainfall, etc.) than human behavior.”\u003c/p>\n\u003cp>Grassly is one of the people who thinks SARS-2 seasonality is falling into place, noting that the Joint Committee on Vaccination and Immunisation — Britain’s equivalent of the Advisory Committee on Immunization Practices, an expert committee that helps the CDC craft vaccination use guidelines — is now recommending a targeted \u003ca href=\"https://www.gov.uk/government/news/jcvi-advises-an-autumn-covid-19-vaccine-booster\">autumn COVID vaccination campaign\u003c/a> for high-risk individuals, in anticipation of a surge of COVID activity this winter. A similar, though more broadly aimed campaign is planned for the United States.\u003c/p>\n\u003cp>“It remains possible that a new variant showing substantial immune escape could spread rapidly, even in summer, and so disrupt seasonal patterns and planning,” Grassly noted. “I think it is hard to estimate the probability that this happens, but it would deviate from the recent pattern of successive Omicron variants which have emerged without large increases in overall incidence.”\u003c/p>\n\u003cp>Stanley Perlman, a coronavirus expert whose bona fides in the field stretch back to the pre-SARS-1 days, agrees with Grassly.\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"‘I think that — at this stage — all we can say is that we can assume that there are some seasonal effects … but that we really cannot say the circulation of these viruses is predictable yet, at least not like we have come to know for flu.’","name":"pullquote","attributes":{"named":{"align":"right","size":"medium","citation":"Marion Koopmans, head of virology, Erasmus Medical Center","label":""},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>“I think for all these viruses” — human coronaviruses — “they probably circulate all year round. But you get large numbers of infections in the late fall, winter, when people are inside, and they spread. That’s what this virus seems to be doing,” said Perlman, a professor of microbiology and immunology at the University of Iowa. “As opposed to last summer, the number of cases is way down this summer. And the prediction is they will increase in the late fall, winter again.”\u003c/p>\n\u003cp>A break from seasonal transmission of respiratory pathogens can be a sign something is amiss, with off-season spread having been observed during flu pandemics going back to the Spanish flu pandemic of 1918. The first observed cases in that pandemic occurred in the spring, at a time when flu season would normally have concluded. The 1957 pandemic began in Asia in February of that year, but the virus arrived in, and started spreading through, the United States, during the summer. The 1968 pandemic began in July. The 2009 H1N1 pandemic was first detected in April and the pandemic’s major wave ran through the summer, peaked in September and trailed off in October.\u003c/p>\n\u003cp>“Pandemic influenza doesn’t follow a seasonal pattern in any way, shape or form,” said Osterholm.\u003c/p>\n\u003cp>It remains to be seen when it will be apparent that SARS-2 has lost its override capabilities, when we’ll feel confident that we know when to expect — plus or minus a month or two — COVID’s annual onslaught.\u003c/p>\n\u003cp>“I think that — at this stage — all we can say is that we can assume that there are some seasonal effects (since we know seasonality does have an effect on other respiratory infections, both by effects on virus stability and on the host) but that we really cannot say the circulation of these viruses is predictable yet, at least not like we have come to know for flu,” Koopmans wrote.\u003c/p>\n\u003cp>\u003cem>This story was originally published by \u003ca href=\"https://www.statnews.com/\">STAT\u003c/a>, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/science/1984081/covid-19-a-disease-with-tricks-up-its-sleeve-hasnt-fallen-into-a-seasonal-pattern-yet","authors":["byline_science_1984081"],"categories":["science_39","science_40","science_4450"],"tags":["science_3643","science_4329","science_1050","science_1520","science_197"],"featImg":"science_1984085","label":"source_science_1984081"},"science_1982342":{"type":"posts","id":"science_1982342","meta":{"index":"posts_1591205157","site":"science","id":"1982342","score":null,"sort":[1682026820000]},"guestAuthors":[],"slug":"social-media-is-boosting-a-billion-dollar-market-for-weight-loss-drugs","title":"Social Media Is Boosting a Billion-Dollar Market for Weight Loss Drugs","publishDate":1682026820,"format":"standard","headTitle":"Social Media Is Boosting a Billion-Dollar Market for Weight Loss Drugs | KQED","labelTerm":{},"content":"\u003cp>Suzette Zuena is her own best advertisement for weight loss.\u003c/p>\n\u003cp>Zuena, the “founder/visionary” of LH Spa and Rejuvenation in Livingston and Madison, New Jersey, has dropped 30 pounds. Her husband has lost 42 pounds.\u003c/p>\n\u003cp>“We go out a lot,” Zuena said of the pair’s social routine. “People saw us basically shrinking.” They would ask how the couple did it. Her response: Point people to her spa and a relatively new type of medication — GLP-1 agonists, a class of drug that’s become a weight-loss phenomenon.\u003c/p>\n\u003cp>But she’s not just spreading her message in person. She’s also doing it on Instagram. And she’s not alone. A chorus of voices is singing these drugs’ praises. Last summer, investment bank Morgan Stanley found that mentions of one of these drugs on TikTok had tripled. People are streaming into doctors’ office to inquire about what they’ve heard are miracle drugs.\u003c/p>\n\u003cp>What these patients have heard, doctors said, is nonstop hype, even misinformation, from social media influencers. “I’ll catch people asking for the skinny pen, the weight loss shot or Ozempic,” said \u003ca href=\"https://nyulangone.org/doctors/1942738547/priya-jaisinghani\">Priya Jaisinghani\u003c/a>, an endocrinologist and clinical assistant professor at New York University’s Grossman School of Medicine.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Competition to claim a market that \u003ca href=\"https://www.cnbc.com/2022/09/09/eli-lillys-weight-treatment-looks-poised-to-become-100-billion-drug.html\">could be worth $100 billion a year\u003c/a> for drugmakers alone has triggered a wave of advertising that has provoked the concern of regulators and doctors worldwide. But their tools for curbing the ads that go too far are limited — especially when it comes to social media. Regulatory systems are most interested in pharma’s claims, not necessarily those of doctors or their enthused patients.\u003c/p>\n\u003cp>Few drugs of this type are approved by the FDA for weight loss — they include Novo Nordisk’s Wegovy. But after shortages made that treatment harder to get, patients turned to other pharmaceuticals — like Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro — which are approved only for Type 2 diabetes. Those are often used off-label — though you wouldn’t hear that from many of their online boosters.\u003c/p>\n\u003cp>The drugs have shown promising \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9063254/\">clinical results\u003c/a>, Jaisinghani and her peers emphasize. Patients can lose as much as \u003ca href=\"https://www.nejm.org/doi/full/10.1056/NEJMoa2032183\">15% of their body weight\u003c/a>. Novo Nordisk is \u003ca href=\"https://www.clinicaltrials.gov/ct2/show/NCT03574597\">sponsoring research\u003c/a> to examine whether Wegovy causes reductions in the rate of heart attacks for patients with obesity.\u003c/p>\n\u003cp>The medications, though, come at a high price. Wegovy runs patients paying cash at least $1,305 a month in the Washington, D.C., area, according to a GoodRx search in late March. Insurers only sometimes cover the cost. And patients typically regain much of their lost weight after they stop taking it.\u003c/p>\n\u003ch2>Hype is driving demand\u003c/h2>\n\u003cp>But patients are not necessarily coming to doctors’ offices now because of the science. They are citing things they saw on TikTok, like \u003ca href=\"https://www.tiktok.com/@pagesix/video/7192648715704782123\">Chelsea Handler\u003c/a> and other celebrities talking about their injections. It leads to the questions “how come she can get it” and “why can I not,” said \u003ca href=\"https://healthcare.utah.edu/find-a-doctor/juliana-s-simonetti\">Juliana Simonetti\u003c/a>, a physician and co-director of the comprehensive weight management program at the University of Utah.\u003c/p>\n\u003cp>The excitement — which doctors worry may cause some patients to use medications inappropriately — is coming also from business interests. Some are doctors promoting their venture-capital-backed start-ups. Others are spas hawking everything from wrinkle smoothing and lip plumping to, yes, weight loss benefits of semaglutide, the active ingredient in Wegovy and Ozempic; their prices, often in the hundreds of dollars, are well below what consumers would pay if picking up the prescription at a pharmacy.\u003c/p>\n\u003cp>In the U.S., the FDA has oversight over ads from the pharmaceutical industry, which must acknowledge risks and side effects of drugs. But ads from people who write prescriptions don’t necessarily have the same restrictions. FDA regulations apply if the prescriber is working on behalf of a regulated entity, like a pharmaceutical manufacturer or distributor.\u003c/p>\n\u003cp>“The FDA is also committed to working with external partners, including the Federal Trade Commission (FTC), to address concerns with prescription drug marketing practices of telehealth companies on various platforms, including social media,” agency spokesperson Jeremy Kahn emailed KFF Health News.\u003c/p>\n\u003cp>Pharma firms run campaigns to educate health care professionals or raise “awareness” that may indirectly tout drugs. Novo Nordisk has an \u003ca href=\"https://www.instagram.com/itsbiggerthan/?hl=en\">ongoing internet campaign\u003c/a> to redefine and destigmatize how Americans think of obesity — and, left unmentioned, the drugs that treat it.\u003c/p>\n\u003cp>KFF Health News also found that, beyond the industry group’s examination, at least two \u003ca href=\"https://www.facebook.com/pharmacymentor/photos/a.386940171690317/1671930236524631/?type=3\">other entities\u003c/a> were promoting Novo Nordisk products in the United Kingdom.\u003c/p>\n\u003cp>\u003ca href=\"https://www.tga.gov.au/\">Australian regulators\u003c/a> have taken down nearly 1,900 ads as of early March for improperly plugging various GLP-1 agonists, an agency spokesperson told KFF Health News. Novo Nordisk says it didn’t put up the ads, the majority of which were for their product Ozempic. The regulators are declining to say who’s involved.\u003c/p>\n\u003cp>Doctors are also sounding alarms about the publicity. They believe patients will be driven to use these medications off-label, obtain unreliable forms of these drugs, or exacerbate other health conditions, like eating disorders. The drugs act in part as an appetite suppressant, which can dramatically reduce calorie intake to a concerning degree when not paired with nutritional guidance.\u003c/p>\n\u003cp>\u003ca href=\"https://www.pathlightbh.com/clinical-leadership/elizabeth-wassenaar\">Elizabeth Wassenaar\u003c/a>, a regional medical director for the Eating Recovery Center, believes the drugs and associated advertising buildup will inadvertently trigger eating disorders. KFF Health News found ads showing thin patients measuring themselves with a tape measure and stepping on the scale, with accompanying captions goading viewers into going on GLP-1s.\u003c/p>\n\u003cp>“They’re being marketed very, very pointedly to groups that are vulnerable to experiencing body image dissatisfaction,” she said.\u003c/p>\n\u003cp>Remi Bader, a curve model and TikTok creator specializing in documenting her “realistic” clothing buys, \u003ca href=\"https://podcasts.apple.com/us/podcast/202-ozempic-boyfriend-reveal-w-remi-bader/id1444559244?i=1000593401739\">told one podcast\u003c/a> her story of coming off a “few months” on Ozempic. She said she gained twice the weight back and that her binge eating disorder got “so much worse.” One study, published in the journal Diabetes, Obesity and Metabolism, found \u003ca href=\"https://dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.14725\">two-thirds of lost weight came back\u003c/a> after discontinuation of semaglutide.\u003c/p>\n\u003cp>But social media users and influencers — whether with white coats or as ordinary patients — are hopping on every platform to spread news of positive weight loss outcomes. There are those, for instance, who had gastric bypass surgery that didn’t work and are now turning to TikTok for guidance, support and hope as they begin taking a GLP-1. There’s even a poop-centric Facebook group in which people discuss the sometimes fraught topic of the drugs’ effect on their bowel movements.\u003c/p>\n\u003ch2>Commercialism and compounding spark excitement and concern\u003c/h2>\n\u003cp>Some have been so delighted by their medication-assisted weight loss they have become brand ambassadors. \u003ca href=\"https://www.tiktok.com/@samanthaislosingit?_t=8b6ouV4H3U6&_r=1\">Samantha Klecyngier\u003c/a> has dropped at least 58 pounds since she started on Mounjaro. She heard of the drug and her telemedicine weight loss program, \u003ca href=\"https://www.joinsequence.com/\">Sequence\u003c/a>, on TikTok. She and many others who have experienced considerable weight loss since starting the medication regimen point to its positive impact and their improved quality of life. Now she officially promotes the company on the app.\u003c/p>\n\u003cp>Though Klecyngier, a mother of two from the Chicago area, is not diabetic, she uses Mounjaro. When she was growing up, her parents had Type 2 diabetes and other chronic diseases that led them both to have open-heart surgery. Her father lost his life to complications of diabetes. She wants to avoid that fate.\u003c/p>\n\u003cp>But Klecyngier’s story — combining a personal journey with a profit-making entity — is symbolic of another trend on social media: commercialism. There’s a spate of start-ups eyeing big money matching pharmaceuticals and related support with patients. (Sequence, the company Klecyngier pitches, \u003ca href=\"https://www.globenewswire.com/news-release/2023/03/06/2621551/0/en/WeightWatchers-to-Acquire-Sequence-a-Digital-Health-Platform-for-Clinical-Weight-Management.html\">just got acquired by WW\u003c/a>, also known as WeightWatchers.)\u003c/p>\n\u003cp>Some doctors use social media to educate viewers about the drugs. \u003ca href=\"https://www.tiktok.com/@michaelalbertmd?lang=en\">Michael Albert\u003c/a>, chief medical officer of telehealth practice \u003ca href=\"https://www.accomplish.health/about\">Accomplish Health\u003c/a>, says offering information to his more than 250,000 followers has helped point patients to the medical practice. It’s received thousands of patient inquiries, more than the clinic can take on.\u003c/p>\n\u003cp>Companies like Accomplish — start-ups with well-credentialed doctors — are the glossy side of this social media boom.\u003c/p>\n\u003cp>But there are others — like many spas and weight-loss centers — that offer the drugs, sometimes without much medical support, often alongside Botox and dermal fillers. Obesity doctors worry such marketing is creating unrealistic expectations.\u003c/p>\n\u003cp>Some spas and telemedicine operators claim to have “compounded” semaglutide. But compounding — when pharmacies, rather than drug manufacturers, prepare a drug — is a risky proposition, doctors caution. “The risks are enormous,” Simonetti said, warning of potential contamination from poor compounding practices. “The risks of getting bacteria,” she warned, “the risks include death.”\u003c/p>\n\u003cp>Weight-loss clinics also frequently tout unconventional additions to semaglutide, including vitamin B12 and amino acids. Some patients incorrectly believe the former helps with nausea, Jaisinghani said; other clinics tout greater weight loss.\u003c/p>\n\u003cp>Novo Nordisk spokesperson Allison Schneider told KFF Health News in an email that the company shares doctors’ concerns about compounding and that it’s begun sending letters warning “certain Health Care Providers” about the related risks.\u003c/p>\n\u003cp>Some operations defend their use of often-cheaper compounded drugs. LH Spa and Rejuvenation, founded by Zuena, offers a compounded semaglutide formulation from \u003ca href=\"https://qrxweightloss.com/\">QRx Weight Loss\u003c/a> for $500 over four weeks. The spa learned about the regimen from a doctor. “I’m purchasing it,” Zuena said. “It comes next-day air in legitimate vials with lot numbers, expirations.” Patients’ injections and dosages are overseen by on-site medical staff.\u003c/p>\n\u003cp>Most operators in this burgeoning industry are keen to emphasize their products’ high quality or their company’s good works, as they seek money. Ro, a telehealth firm offering GLP-1s, said its marketing campaign in the New York City subway “aims to start an important, sometimes difficult, conversation focused on de-stigmatizing obesity as a condition.”\u003c/p>\n\u003cp>This widespread tactic is nothing short of maddening for pharma industry critics. “They talk about trying to destigmatize obesity at the same time they’re talking about losing weight. They’re co-opting the concept,” said Judy Butler, a research fellow at \u003ca href=\"https://sites.google.com/georgetown.edu/pharmedout/home?authuser=0\">PharmedOut\u003c/a>, a Georgetown University Medical Center project focusing on evidence-based practices for drugs. “They’re trying to sell a weight-loss drug.”\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>This story was produced by \u003ca href=\"http://khn.org/\">Kaiser Health News\u003c/a>, an editorially independent program of the \u003ca href=\"https://www.kff.org/\">Kaiser Family Foundation\u003c/a>.\u003c/em>\u003c/p>\n\n","blocks":[],"excerpt":"Online platforms are overflowing with testimonials for GLP-1s. The drugs show promise for inducing weight loss, but many aren’t FDA-approved for that use.","status":"publish","parent":0,"modified":1704846042,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":36,"wordCount":1819},"headData":{"title":"Social Media Is Boosting a Billion-Dollar Market for Weight Loss Drugs | KQED","description":"Online platforms are overflowing with testimonials for GLP-1s. The drugs show promise for inducing weight loss, but many aren’t FDA-approved for that use.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Social Media Is Boosting a Billion-Dollar Market for Weight Loss Drugs","datePublished":"2023-04-20T21:40:20.000Z","dateModified":"2024-01-10T00:20:42.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"source":"Kaiser Health News","sticky":false,"nprByline":"Darius Tahir and Hannah Norman \u003cbr>Kaiser Health News\u003c/br>","excludeFromSiteSearch":"Include","showOnAuthorArchivePages":"No","articleAge":"0","path":"/science/1982342/social-media-is-boosting-a-billion-dollar-market-for-weight-loss-drugs","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Suzette Zuena is her own best advertisement for weight loss.\u003c/p>\n\u003cp>Zuena, the “founder/visionary” of LH Spa and Rejuvenation in Livingston and Madison, New Jersey, has dropped 30 pounds. Her husband has lost 42 pounds.\u003c/p>\n\u003cp>“We go out a lot,” Zuena said of the pair’s social routine. “People saw us basically shrinking.” They would ask how the couple did it. Her response: Point people to her spa and a relatively new type of medication — GLP-1 agonists, a class of drug that’s become a weight-loss phenomenon.\u003c/p>\n\u003cp>But she’s not just spreading her message in person. She’s also doing it on Instagram. And she’s not alone. A chorus of voices is singing these drugs’ praises. Last summer, investment bank Morgan Stanley found that mentions of one of these drugs on TikTok had tripled. People are streaming into doctors’ office to inquire about what they’ve heard are miracle drugs.\u003c/p>\n\u003cp>What these patients have heard, doctors said, is nonstop hype, even misinformation, from social media influencers. “I’ll catch people asking for the skinny pen, the weight loss shot or Ozempic,” said \u003ca href=\"https://nyulangone.org/doctors/1942738547/priya-jaisinghani\">Priya Jaisinghani\u003c/a>, an endocrinologist and clinical assistant professor at New York University’s Grossman School of Medicine.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Competition to claim a market that \u003ca href=\"https://www.cnbc.com/2022/09/09/eli-lillys-weight-treatment-looks-poised-to-become-100-billion-drug.html\">could be worth $100 billion a year\u003c/a> for drugmakers alone has triggered a wave of advertising that has provoked the concern of regulators and doctors worldwide. But their tools for curbing the ads that go too far are limited — especially when it comes to social media. Regulatory systems are most interested in pharma’s claims, not necessarily those of doctors or their enthused patients.\u003c/p>\n\u003cp>Few drugs of this type are approved by the FDA for weight loss — they include Novo Nordisk’s Wegovy. But after shortages made that treatment harder to get, patients turned to other pharmaceuticals — like Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro — which are approved only for Type 2 diabetes. Those are often used off-label — though you wouldn’t hear that from many of their online boosters.\u003c/p>\n\u003cp>The drugs have shown promising \u003ca href=\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9063254/\">clinical results\u003c/a>, Jaisinghani and her peers emphasize. Patients can lose as much as \u003ca href=\"https://www.nejm.org/doi/full/10.1056/NEJMoa2032183\">15% of their body weight\u003c/a>. Novo Nordisk is \u003ca href=\"https://www.clinicaltrials.gov/ct2/show/NCT03574597\">sponsoring research\u003c/a> to examine whether Wegovy causes reductions in the rate of heart attacks for patients with obesity.\u003c/p>\n\u003cp>The medications, though, come at a high price. Wegovy runs patients paying cash at least $1,305 a month in the Washington, D.C., area, according to a GoodRx search in late March. Insurers only sometimes cover the cost. And patients typically regain much of their lost weight after they stop taking it.\u003c/p>\n\u003ch2>Hype is driving demand\u003c/h2>\n\u003cp>But patients are not necessarily coming to doctors’ offices now because of the science. They are citing things they saw on TikTok, like \u003ca href=\"https://www.tiktok.com/@pagesix/video/7192648715704782123\">Chelsea Handler\u003c/a> and other celebrities talking about their injections. It leads to the questions “how come she can get it” and “why can I not,” said \u003ca href=\"https://healthcare.utah.edu/find-a-doctor/juliana-s-simonetti\">Juliana Simonetti\u003c/a>, a physician and co-director of the comprehensive weight management program at the University of Utah.\u003c/p>\n\u003cp>The excitement — which doctors worry may cause some patients to use medications inappropriately — is coming also from business interests. Some are doctors promoting their venture-capital-backed start-ups. Others are spas hawking everything from wrinkle smoothing and lip plumping to, yes, weight loss benefits of semaglutide, the active ingredient in Wegovy and Ozempic; their prices, often in the hundreds of dollars, are well below what consumers would pay if picking up the prescription at a pharmacy.\u003c/p>\n\u003cp>In the U.S., the FDA has oversight over ads from the pharmaceutical industry, which must acknowledge risks and side effects of drugs. But ads from people who write prescriptions don’t necessarily have the same restrictions. FDA regulations apply if the prescriber is working on behalf of a regulated entity, like a pharmaceutical manufacturer or distributor.\u003c/p>\n\u003cp>“The FDA is also committed to working with external partners, including the Federal Trade Commission (FTC), to address concerns with prescription drug marketing practices of telehealth companies on various platforms, including social media,” agency spokesperson Jeremy Kahn emailed KFF Health News.\u003c/p>\n\u003cp>Pharma firms run campaigns to educate health care professionals or raise “awareness” that may indirectly tout drugs. Novo Nordisk has an \u003ca href=\"https://www.instagram.com/itsbiggerthan/?hl=en\">ongoing internet campaign\u003c/a> to redefine and destigmatize how Americans think of obesity — and, left unmentioned, the drugs that treat it.\u003c/p>\n\u003cp>KFF Health News also found that, beyond the industry group’s examination, at least two \u003ca href=\"https://www.facebook.com/pharmacymentor/photos/a.386940171690317/1671930236524631/?type=3\">other entities\u003c/a> were promoting Novo Nordisk products in the United Kingdom.\u003c/p>\n\u003cp>\u003ca href=\"https://www.tga.gov.au/\">Australian regulators\u003c/a> have taken down nearly 1,900 ads as of early March for improperly plugging various GLP-1 agonists, an agency spokesperson told KFF Health News. Novo Nordisk says it didn’t put up the ads, the majority of which were for their product Ozempic. The regulators are declining to say who’s involved.\u003c/p>\n\u003cp>Doctors are also sounding alarms about the publicity. They believe patients will be driven to use these medications off-label, obtain unreliable forms of these drugs, or exacerbate other health conditions, like eating disorders. The drugs act in part as an appetite suppressant, which can dramatically reduce calorie intake to a concerning degree when not paired with nutritional guidance.\u003c/p>\n\u003cp>\u003ca href=\"https://www.pathlightbh.com/clinical-leadership/elizabeth-wassenaar\">Elizabeth Wassenaar\u003c/a>, a regional medical director for the Eating Recovery Center, believes the drugs and associated advertising buildup will inadvertently trigger eating disorders. KFF Health News found ads showing thin patients measuring themselves with a tape measure and stepping on the scale, with accompanying captions goading viewers into going on GLP-1s.\u003c/p>\n\u003cp>“They’re being marketed very, very pointedly to groups that are vulnerable to experiencing body image dissatisfaction,” she said.\u003c/p>\n\u003cp>Remi Bader, a curve model and TikTok creator specializing in documenting her “realistic” clothing buys, \u003ca href=\"https://podcasts.apple.com/us/podcast/202-ozempic-boyfriend-reveal-w-remi-bader/id1444559244?i=1000593401739\">told one podcast\u003c/a> her story of coming off a “few months” on Ozempic. She said she gained twice the weight back and that her binge eating disorder got “so much worse.” One study, published in the journal Diabetes, Obesity and Metabolism, found \u003ca href=\"https://dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.14725\">two-thirds of lost weight came back\u003c/a> after discontinuation of semaglutide.\u003c/p>\n\u003cp>But social media users and influencers — whether with white coats or as ordinary patients — are hopping on every platform to spread news of positive weight loss outcomes. There are those, for instance, who had gastric bypass surgery that didn’t work and are now turning to TikTok for guidance, support and hope as they begin taking a GLP-1. There’s even a poop-centric Facebook group in which people discuss the sometimes fraught topic of the drugs’ effect on their bowel movements.\u003c/p>\n\u003ch2>Commercialism and compounding spark excitement and concern\u003c/h2>\n\u003cp>Some have been so delighted by their medication-assisted weight loss they have become brand ambassadors. \u003ca href=\"https://www.tiktok.com/@samanthaislosingit?_t=8b6ouV4H3U6&_r=1\">Samantha Klecyngier\u003c/a> has dropped at least 58 pounds since she started on Mounjaro. She heard of the drug and her telemedicine weight loss program, \u003ca href=\"https://www.joinsequence.com/\">Sequence\u003c/a>, on TikTok. She and many others who have experienced considerable weight loss since starting the medication regimen point to its positive impact and their improved quality of life. Now she officially promotes the company on the app.\u003c/p>\n\u003cp>Though Klecyngier, a mother of two from the Chicago area, is not diabetic, she uses Mounjaro. When she was growing up, her parents had Type 2 diabetes and other chronic diseases that led them both to have open-heart surgery. Her father lost his life to complications of diabetes. She wants to avoid that fate.\u003c/p>\n\u003cp>But Klecyngier’s story — combining a personal journey with a profit-making entity — is symbolic of another trend on social media: commercialism. There’s a spate of start-ups eyeing big money matching pharmaceuticals and related support with patients. (Sequence, the company Klecyngier pitches, \u003ca href=\"https://www.globenewswire.com/news-release/2023/03/06/2621551/0/en/WeightWatchers-to-Acquire-Sequence-a-Digital-Health-Platform-for-Clinical-Weight-Management.html\">just got acquired by WW\u003c/a>, also known as WeightWatchers.)\u003c/p>\n\u003cp>Some doctors use social media to educate viewers about the drugs. \u003ca href=\"https://www.tiktok.com/@michaelalbertmd?lang=en\">Michael Albert\u003c/a>, chief medical officer of telehealth practice \u003ca href=\"https://www.accomplish.health/about\">Accomplish Health\u003c/a>, says offering information to his more than 250,000 followers has helped point patients to the medical practice. It’s received thousands of patient inquiries, more than the clinic can take on.\u003c/p>\n\u003cp>Companies like Accomplish — start-ups with well-credentialed doctors — are the glossy side of this social media boom.\u003c/p>\n\u003cp>But there are others — like many spas and weight-loss centers — that offer the drugs, sometimes without much medical support, often alongside Botox and dermal fillers. Obesity doctors worry such marketing is creating unrealistic expectations.\u003c/p>\n\u003cp>Some spas and telemedicine operators claim to have “compounded” semaglutide. But compounding — when pharmacies, rather than drug manufacturers, prepare a drug — is a risky proposition, doctors caution. “The risks are enormous,” Simonetti said, warning of potential contamination from poor compounding practices. “The risks of getting bacteria,” she warned, “the risks include death.”\u003c/p>\n\u003cp>Weight-loss clinics also frequently tout unconventional additions to semaglutide, including vitamin B12 and amino acids. Some patients incorrectly believe the former helps with nausea, Jaisinghani said; other clinics tout greater weight loss.\u003c/p>\n\u003cp>Novo Nordisk spokesperson Allison Schneider told KFF Health News in an email that the company shares doctors’ concerns about compounding and that it’s begun sending letters warning “certain Health Care Providers” about the related risks.\u003c/p>\n\u003cp>Some operations defend their use of often-cheaper compounded drugs. LH Spa and Rejuvenation, founded by Zuena, offers a compounded semaglutide formulation from \u003ca href=\"https://qrxweightloss.com/\">QRx Weight Loss\u003c/a> for $500 over four weeks. The spa learned about the regimen from a doctor. “I’m purchasing it,” Zuena said. “It comes next-day air in legitimate vials with lot numbers, expirations.” Patients’ injections and dosages are overseen by on-site medical staff.\u003c/p>\n\u003cp>Most operators in this burgeoning industry are keen to emphasize their products’ high quality or their company’s good works, as they seek money. Ro, a telehealth firm offering GLP-1s, said its marketing campaign in the New York City subway “aims to start an important, sometimes difficult, conversation focused on de-stigmatizing obesity as a condition.”\u003c/p>\n\u003cp>This widespread tactic is nothing short of maddening for pharma industry critics. “They talk about trying to destigmatize obesity at the same time they’re talking about losing weight. They’re co-opting the concept,” said Judy Butler, a research fellow at \u003ca href=\"https://sites.google.com/georgetown.edu/pharmedout/home?authuser=0\">PharmedOut\u003c/a>, a Georgetown University Medical Center project focusing on evidence-based practices for drugs. “They’re trying to sell a weight-loss drug.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>This story was produced by \u003ca href=\"http://khn.org/\">Kaiser Health News\u003c/a>, an editorially independent program of the \u003ca href=\"https://www.kff.org/\">Kaiser Family Foundation\u003c/a>.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/science/1982342/social-media-is-boosting-a-billion-dollar-market-for-weight-loss-drugs","authors":["byline_science_1982342"],"categories":["science_39","science_40","science_4450"],"tags":["science_3541","science_1050","science_5181","science_2918","science_697"],"featImg":"science_1982346","label":"source_science_1982342"},"science_1982345":{"type":"posts","id":"science_1982345","meta":{"index":"posts_1591205157","site":"science","id":"1982345","score":null,"sort":[1682017468000]},"guestAuthors":[],"slug":"california-clinics-promise-no-interruption-in-abortion-care-as-supreme-court-weighs-restrictions-on-mifepristone","title":"California Clinics Promise No Interruption in Abortion Care as Supreme Court Weighs Restrictions on Mifepristone","publishDate":1682017468,"format":"standard","headTitle":"California Clinics Promise No Interruption in Abortion Care as Supreme Court Weighs Restrictions on Mifepristone | KQED","labelTerm":{},"content":"\u003cp>Planned Parenthood Northern California is vowing to maintain stability in abortion care in the region, should the U.S. Supreme Court decide to temporarily limit or ban the abortion medication mifepristone, while it sorts through conflicting lower court rulings over the drug.\u003c/p>\n\u003cp>Amid the legal uncertainty of recent weeks, clinicians and staff at the organization’s \u003ca href=\"https://www.plannedparenthood.org/planned-parenthood-northern-california/get-care/our-health-centers\">17 clinics\u003c/a>, from San Francisco to Chico to Eureka, have been training to shift their protocol for medication abortion from a two-drug regimen, to just one drug, if needed.\u003c/p>\n\u003cp>“We know this is part of the opposition’s agenda, to create confusion and chaos,” said Gilda Gonzales, CEO of Planned Parenthood Northern California. “We’re committed to never having an interruption in the care that we provide our patients.”\u003c/p>\n\u003cp>About 55% of patients in the region opt for medication abortion, Gonzales said, which normally involves two medications: mifepristone first, to stop the pregnancy hormone progesterone; then misoprostol, to cause contractions and empty the uterus.\u003c/p>\n\u003cp>If the courts restrict access to mifepristone, the clinics will rely solely on the second drug, misoprostol. The \u003ca href=\"https://www.npr.org/sections/health-shots/2023/04/10/1168857095/misoprostol-only-medical-abortion\">one-drug protocol\u003c/a> is about 5% less effective than the two, though still roughly 90% effective overall in the first trimester, according to UCSF professor of obstetrics and gynecology Daniel Grossman, though it usually causes more side effects, like nausea, vomiting, diarrhea and longer-lasting cramping and bleeding.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“As an American, I’m horrified,” Gonzales said, “because if judges can make decisions about drugs that have been utilized for decades based on junk science, and they come off the market, that is a really, really horrible condition.”\u003c/p>\n\u003ch2>California’s response diverges from other liberal states\u003c/h2>\n\u003cp>The Food and Drug Administration first approved mifepristone in 2000. But last fall, a group of anti-abortion physicians called into question the drug’s safety and alleged the agency’s approval of it was wrong. A federal judge in Texas agreed and on April 7 ordered the FDA to suspend availability nationwide. At the same time, a judge in the state of Washington ordered the FDA to preserve the status quo, but that ruling only applied to the 17 Democratic-led states that signed on.\u003c/p>\n\u003cp>California, notably, was not one of them, a decision the state’s attorney general, Rob Bonta, defended on Tuesday as “intentional,” “deliberate” and “strategic.”\u003c/p>\n\u003cp>Blue states are dividing and conquering, he said, with some joining the Washington suit, and others like California, New York and Massachusetts pursuing a different path.\u003c/p>\n\u003cp>“The Washington lawsuit is a suit against the FDA. They are suing the federal government,” he said. “We believe it’s important to have some states, including California, that continue to collaborate, partner and work with the federal government. We are doing that.”\u003c/p>\n\u003cp>In the meantime, California started to build an emergency stockpile of both abortion medications, with the state receiving 250,000 pills of misoprostol last week, with the ability to obtain another 2 million if needed. Gov. Gavin Newsom even implied the state could “set up shop here” and manufacture the medications under California’s generic drug label, CalRx.\u003c/p>\n\u003cp>“And don’t think for a second we don’t have more ideas,” Newsom said Tuesday.\u003c/p>\n\u003cp>The Texas lawsuit is now before the Supreme Court, which has until Friday evening to either extend a stay that maintains availability of mifepristone while the case moves through the court system, or let it expire.\u003c/p>\n\u003cp>If the justices do tell the FDA to restrict mifepristone, the agency could use its discretion and choose not to invest time or money in enforcing the ruling.\u003c/p>\n\u003cp>“Not everybody who speeds gets pulled over. Not everybody who smokes marijuana gets arrested. So the FDA could make off-label use of mifepristone a low priority,” UC Davis law professor Mary Ziegler said. From there, “it would depend on the comfort level” of pharmacies, doctors and clinics in California, to decide whether they want to count on the FDA looking the other way or not.\u003c/p>\n\u003cp>Planned Parenthood’s Northern California clinics won’t defy court orders, Gonzales said, because of the intense political spotlight her organization is under and its continued reliance on federal funding that is routinely under threat. If there is any kind of limit put on mifepristone, for any period of time, she said, they will quickly move to a misoprostol-only protocol until the legal matters are fully resolved.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“For us to be stewing or circling in non-clarity will not serve our patients well,” she said. “It is not a surrendering. It is a radical decision for non-interruption.”\u003c/p>\n\n","blocks":[],"excerpt":"Planned Parenthood Northern California is vowing to maintain stability in abortion care in the region.","status":"publish","parent":0,"modified":1704846045,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":19,"wordCount":802},"headData":{"title":"California Clinics Promise No Interruption in Abortion Care as Supreme Court Weighs Restrictions on Mifepristone | KQED","description":"Planned Parenthood Northern California is vowing to maintain stability in abortion care in the region.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"California Clinics Promise No Interruption in Abortion Care as Supreme Court Weighs Restrictions on Mifepristone","datePublished":"2023-04-20T19:04:28.000Z","dateModified":"2024-01-10T00:20:45.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"source":"Abortion","sticky":false,"excludeFromSiteSearch":"Include","articleAge":"0","path":"/science/1982345/california-clinics-promise-no-interruption-in-abortion-care-as-supreme-court-weighs-restrictions-on-mifepristone","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Planned Parenthood Northern California is vowing to maintain stability in abortion care in the region, should the U.S. Supreme Court decide to temporarily limit or ban the abortion medication mifepristone, while it sorts through conflicting lower court rulings over the drug.\u003c/p>\n\u003cp>Amid the legal uncertainty of recent weeks, clinicians and staff at the organization’s \u003ca href=\"https://www.plannedparenthood.org/planned-parenthood-northern-california/get-care/our-health-centers\">17 clinics\u003c/a>, from San Francisco to Chico to Eureka, have been training to shift their protocol for medication abortion from a two-drug regimen, to just one drug, if needed.\u003c/p>\n\u003cp>“We know this is part of the opposition’s agenda, to create confusion and chaos,” said Gilda Gonzales, CEO of Planned Parenthood Northern California. “We’re committed to never having an interruption in the care that we provide our patients.”\u003c/p>\n\u003cp>About 55% of patients in the region opt for medication abortion, Gonzales said, which normally involves two medications: mifepristone first, to stop the pregnancy hormone progesterone; then misoprostol, to cause contractions and empty the uterus.\u003c/p>\n\u003cp>If the courts restrict access to mifepristone, the clinics will rely solely on the second drug, misoprostol. The \u003ca href=\"https://www.npr.org/sections/health-shots/2023/04/10/1168857095/misoprostol-only-medical-abortion\">one-drug protocol\u003c/a> is about 5% less effective than the two, though still roughly 90% effective overall in the first trimester, according to UCSF professor of obstetrics and gynecology Daniel Grossman, though it usually causes more side effects, like nausea, vomiting, diarrhea and longer-lasting cramping and bleeding.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“As an American, I’m horrified,” Gonzales said, “because if judges can make decisions about drugs that have been utilized for decades based on junk science, and they come off the market, that is a really, really horrible condition.”\u003c/p>\n\u003ch2>California’s response diverges from other liberal states\u003c/h2>\n\u003cp>The Food and Drug Administration first approved mifepristone in 2000. But last fall, a group of anti-abortion physicians called into question the drug’s safety and alleged the agency’s approval of it was wrong. A federal judge in Texas agreed and on April 7 ordered the FDA to suspend availability nationwide. At the same time, a judge in the state of Washington ordered the FDA to preserve the status quo, but that ruling only applied to the 17 Democratic-led states that signed on.\u003c/p>\n\u003cp>California, notably, was not one of them, a decision the state’s attorney general, Rob Bonta, defended on Tuesday as “intentional,” “deliberate” and “strategic.”\u003c/p>\n\u003cp>Blue states are dividing and conquering, he said, with some joining the Washington suit, and others like California, New York and Massachusetts pursuing a different path.\u003c/p>\n\u003cp>“The Washington lawsuit is a suit against the FDA. They are suing the federal government,” he said. “We believe it’s important to have some states, including California, that continue to collaborate, partner and work with the federal government. We are doing that.”\u003c/p>\n\u003cp>In the meantime, California started to build an emergency stockpile of both abortion medications, with the state receiving 250,000 pills of misoprostol last week, with the ability to obtain another 2 million if needed. Gov. Gavin Newsom even implied the state could “set up shop here” and manufacture the medications under California’s generic drug label, CalRx.\u003c/p>\n\u003cp>“And don’t think for a second we don’t have more ideas,” Newsom said Tuesday.\u003c/p>\n\u003cp>The Texas lawsuit is now before the Supreme Court, which has until Friday evening to either extend a stay that maintains availability of mifepristone while the case moves through the court system, or let it expire.\u003c/p>\n\u003cp>If the justices do tell the FDA to restrict mifepristone, the agency could use its discretion and choose not to invest time or money in enforcing the ruling.\u003c/p>\n\u003cp>“Not everybody who speeds gets pulled over. Not everybody who smokes marijuana gets arrested. So the FDA could make off-label use of mifepristone a low priority,” UC Davis law professor Mary Ziegler said. From there, “it would depend on the comfort level” of pharmacies, doctors and clinics in California, to decide whether they want to count on the FDA looking the other way or not.\u003c/p>\n\u003cp>Planned Parenthood’s Northern California clinics won’t defy court orders, Gonzales said, because of the intense political spotlight her organization is under and its continued reliance on federal funding that is routinely under threat. If there is any kind of limit put on mifepristone, for any period of time, she said, they will quickly move to a misoprostol-only protocol until the legal matters are fully resolved.\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“For us to be stewing or circling in non-clarity will not serve our patients well,” she said. “It is not a surrendering. It is a radical decision for non-interruption.”\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/science/1982345/california-clinics-promise-no-interruption-in-abortion-care-as-supreme-court-weighs-restrictions-on-mifepristone","authors":["3205"],"categories":["science_39","science_40","science_4450"],"tags":["science_5178","science_1050"],"featImg":"science_1982348","label":"source_science_1982345"},"science_1979952":{"type":"posts","id":"science_1979952","meta":{"index":"posts_1591205157","site":"science","id":"1979952","score":null,"sort":[1659746166000]},"guestAuthors":[],"slug":"monkeypox-vaccines-california-and-fda-do-not-agree-on-how-to-stretch-meager-supply","title":"Monkeypox Vaccines: California and FDA Do Not Agree on How to Stretch Meager Supply","publishDate":1659746166,"format":"standard","headTitle":"Monkeypox Vaccines: California and FDA Do Not Agree on How to Stretch Meager Supply | KQED","labelTerm":{},"content":"\u003cp>As monkeypox spreads rapidly, everyone agrees that the meager supply of vaccine needs to be improved.\u003c/p>\n\u003cp>But how exactly to stretch the limited supply? That’s where California and its progressive cities have diverged from federal regulators.\u003c/p>\n\u003cp>California’s top health officials advised local agencies in a July 27 memo to \u003ca href=\"https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/Monkeypox-vaccine-doses.aspx#\">prioritize a single dose of the two-dose monkeypox vaccine for people who are most at risk\u003c/a>. For weeks, San Francisco has used this strategy to spread its limited supply of monkeypox vaccine to people in the city who are at high risk of contracting the disease.\u003c/p>\n\u003cp>Officials with the Centers for Disease Control and Prevention and the Food and Drug Administration \u003ca href=\"https://www.statnews.com/2022/07/15/nyc-one-dose-monkeypox-strategy-cdc-fda-warnings-against/\">have warned health providers against deviating from the approved schedule\u003c/a>. The vaccine is supposed to be given in two doses, with the second one administered 28 days after the first.\u003c/p>\n\u003cp>“We do not recommend to go off of the recommended schedule here,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, \u003ca href=\"https://www.statnews.com/2022/07/15/nyc-one-dose-monkeypox-strategy-cdc-fda-warnings-against/\" target=\"_blank\" rel=\"noopener noreferrer\">at a press conference organized by the Department of Health and Human Services\u003c/a>. For people most at risk, he added, “A single dose of this vaccine will not provide the kind of protection over time that is necessary.”[aside postID=news_11920455 hero='https://ww2.kqed.org/app/uploads/sites/10/2022/07/RS57399_GettyImages-1408879341-qut-1020x765.jpg']\u003c/p>\n\u003ch2>‘Dose sparing’\u003c/h2>\n\u003cp>Now, the FDA is considering a “dose sparing” proposal that would allow health providers to use a single-dose vial of vaccine to administer a total of up to five separate doses. The plan would require changing how the vaccine is administered. Rather than an injection that goes into the fatty tissues underneath the skin, known as subcutaneous administration, people would receive it through a small needle placed delicately under the top layer of skin.\u003c/p>\n\u003cp>This is called intradermal administration, and giving vaccines intradermally can also result in a strong immune response.\u003c/p>\n\u003cp>“The FDA has identified a potential solution that would allow us to significantly increase the number of doses available [for] administration,” an agency spokesperson told KQED in an emailed statement on Friday.\u003c/p>\n\u003cp>“It’s important to note that overall safety and efficacy profile would not be sacrificed with this approach,” the statement said. “The virus has continued to spread at a pace and rate in recent weeks that made it clear to all of us that we would not meet current demand with the current supply.”\u003c/p>\n\u003cp>The FDA’s alternate strategy is now under consideration and not yet approved — nor is it clear when it might be.\u003c/p>\n\u003ch2>The single dose strategy\u003c/h2>\n\u003cp>Health experts warn that the U.S. might not be able to contain the monkeypox outbreak, which has already infected thousands of Americans. And San Francisco has said it is important to take quick action in order to protect the most people.\u003c/p>\n\u003cp>KQED’s Community Engagement Reporter Carlos Cabrera-Lomelí reported that people seeking a jab at a vaccine clinic at Zuckerberg San Francisco General Hospital and Trauma Center are not being offered second shots right now.\u003c/p>\n\u003cp>https://twitter.com/LomeliCabrera/status/1554845594161598464?s=20&t=AM_k84nHNl35wO0Z-3GI8w\u003c/p>\n\u003cp>Instead, San Francisco’s health department is prioritizing first doses of Jynneos, delaying the second. Cabrera-Lomelí reported that patients attending the clinic at Zuckerberg San Francisco General Hospital and Trauma Center\u003cstrong>,\u003c/strong> the city’s only walk-in monkeypox vaccine clinic, were told by hospital staff that their second shot could safely be delayed as long as two years.\u003c/p>\n\u003cp>City officials told KQED in an email that “although data on the full efficacy of a first dose of the Jynneos monkeypox vaccine is not fully known, the information that we do have and relevant studies on the topic, allows us to take this temporary harm reduction approach while vaccine supply increases.”\u003c/p>\n\u003cp>\u003ca href=\"https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/Monkeypox-vaccine-doses.aspx#\">California’s health department laid out a rationale for a single shot plan\u003c/a> in the memo it sent to local agencies, noting that in the eradication of smallpox — a poxvirus genetically very similar to monkeypox — the first vaccine dose provided quick protection. Clinical trials in humans and animals measuring immunity from the Jynneos have produced similar results.\u003c/p>\n\u003cp>“While supplies remain scarce, vaccinators in California may offer first doses of JYNNEOS [sic] to additional persons at risk rather than retain inventory as second doses for immunocompetent persons, even if second doses are consequently administered at an interval greater than 28 days,” the memo said.\u003c/p>\n\u003cp>The health department said people who are immunocompromised are still eligible to received two doses. \u003cspan style=\"font-weight: 400\">[aside postID=news_11919070 hero='https://ww2.kqed.org/app/uploads/sites/10/2022/07/RS57170_GettyImages-1401390462-qut.jpg']\u003c/span>\u003c/p>\n\u003cp>UCSF’s Dr. Peter Chin-Hong told KQED in an email that it “is indeed safe not to get a second dose of the vaccine at 28 days, on time.”\u003c/p>\n\u003cp>\u003ca href=\"https://www.statnews.com/2022/07/15/nyc-one-dose-monkeypox-strategy-cdc-fda-warnings-against/\">New York, the United Kingdom and Canada are delaying the vaccine boosters\u003c/a>, too. Science magazine reported that \u003ca href=\"https://www.science.org/content/article/there-s-shortage-monkeypox-vaccine-could-one-dose-instead-two-suffice\">Paul Chaplin, an immunologist and CEO of Bavarian Nordic \u003c/a>— the company that manufactures the vaccine — also endorses the single dose plan.\u003c/p>\n\u003cp>\u003ca href=\"https://www.science.org/content/article/there-s-shortage-monkeypox-vaccine-could-one-dose-instead-two-suffice\">Federal scientists have cautioned that a single dose regime of vaccine hasn’t been studied\u003c/a> in an actual outbreak.\u003c/p>\n\u003cp>Jynneos is the only vaccine currently approved for the prevention of monkeypox in the United States.\u003c/p>\n\u003cp>San Francisco health officials say people, “especially those who have only received one dose,” should limit their risk of exposure to monkeypox before and after being vaccinated and second doses will be offered “once supply allows.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\u003c/p>\n","blocks":[],"excerpt":"California advises health providers to use a single dose of vaccine; the FDA is considering a proposal that would allow health providers to use a smaller amount—but it's not ready yet. ","status":"publish","parent":0,"modified":1704846223,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":24,"wordCount":953},"headData":{"title":"Monkeypox Vaccines: California and FDA Do Not Agree on How to Stretch Meager Supply | KQED","description":"California advises health providers to use a single dose of vaccine; the FDA is considering a proposal that would allow health providers to use a smaller amount—but it's not ready yet. ","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Monkeypox Vaccines: California and FDA Do Not Agree on How to Stretch Meager Supply","datePublished":"2022-08-06T00:36:06.000Z","dateModified":"2024-01-10T00:23:43.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"source":"Monkeypox ","sticky":false,"excludeFromSiteSearch":"Include","path":"/science/1979952/monkeypox-vaccines-california-and-fda-do-not-agree-on-how-to-stretch-meager-supply","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>As monkeypox spreads rapidly, everyone agrees that the meager supply of vaccine needs to be improved.\u003c/p>\n\u003cp>But how exactly to stretch the limited supply? That’s where California and its progressive cities have diverged from federal regulators.\u003c/p>\n\u003cp>California’s top health officials advised local agencies in a July 27 memo to \u003ca href=\"https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/Monkeypox-vaccine-doses.aspx#\">prioritize a single dose of the two-dose monkeypox vaccine for people who are most at risk\u003c/a>. For weeks, San Francisco has used this strategy to spread its limited supply of monkeypox vaccine to people in the city who are at high risk of contracting the disease.\u003c/p>\n\u003cp>Officials with the Centers for Disease Control and Prevention and the Food and Drug Administration \u003ca href=\"https://www.statnews.com/2022/07/15/nyc-one-dose-monkeypox-strategy-cdc-fda-warnings-against/\">have warned health providers against deviating from the approved schedule\u003c/a>. The vaccine is supposed to be given in two doses, with the second one administered 28 days after the first.\u003c/p>\n\u003cp>“We do not recommend to go off of the recommended schedule here,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, \u003ca href=\"https://www.statnews.com/2022/07/15/nyc-one-dose-monkeypox-strategy-cdc-fda-warnings-against/\" target=\"_blank\" rel=\"noopener noreferrer\">at a press conference organized by the Department of Health and Human Services\u003c/a>. For people most at risk, he added, “A single dose of this vaccine will not provide the kind of protection over time that is necessary.”\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"aside","attributes":{"named":{"postid":"news_11920455","hero":"https://ww2.kqed.org/app/uploads/sites/10/2022/07/RS57399_GettyImages-1408879341-qut-1020x765.jpg","label":""},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003ch2>‘Dose sparing’\u003c/h2>\n\u003cp>Now, the FDA is considering a “dose sparing” proposal that would allow health providers to use a single-dose vial of vaccine to administer a total of up to five separate doses. The plan would require changing how the vaccine is administered. Rather than an injection that goes into the fatty tissues underneath the skin, known as subcutaneous administration, people would receive it through a small needle placed delicately under the top layer of skin.\u003c/p>\n\u003cp>This is called intradermal administration, and giving vaccines intradermally can also result in a strong immune response.\u003c/p>\n\u003cp>“The FDA has identified a potential solution that would allow us to significantly increase the number of doses available [for] administration,” an agency spokesperson told KQED in an emailed statement on Friday.\u003c/p>\n\u003cp>“It’s important to note that overall safety and efficacy profile would not be sacrificed with this approach,” the statement said. “The virus has continued to spread at a pace and rate in recent weeks that made it clear to all of us that we would not meet current demand with the current supply.”\u003c/p>\n\u003cp>The FDA’s alternate strategy is now under consideration and not yet approved — nor is it clear when it might be.\u003c/p>\n\u003ch2>The single dose strategy\u003c/h2>\n\u003cp>Health experts warn that the U.S. might not be able to contain the monkeypox outbreak, which has already infected thousands of Americans. And San Francisco has said it is important to take quick action in order to protect the most people.\u003c/p>\n\u003cp>KQED’s Community Engagement Reporter Carlos Cabrera-Lomelí reported that people seeking a jab at a vaccine clinic at Zuckerberg San Francisco General Hospital and Trauma Center are not being offered second shots right now.\u003c/p>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"singleTwitterStatus","attributes":{"named":{"id":"1554845594161598464"},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\n\u003cp>Instead, San Francisco’s health department is prioritizing first doses of Jynneos, delaying the second. Cabrera-Lomelí reported that patients attending the clinic at Zuckerberg San Francisco General Hospital and Trauma Center\u003cstrong>,\u003c/strong> the city’s only walk-in monkeypox vaccine clinic, were told by hospital staff that their second shot could safely be delayed as long as two years.\u003c/p>\n\u003cp>City officials told KQED in an email that “although data on the full efficacy of a first dose of the Jynneos monkeypox vaccine is not fully known, the information that we do have and relevant studies on the topic, allows us to take this temporary harm reduction approach while vaccine supply increases.”\u003c/p>\n\u003cp>\u003ca href=\"https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/Monkeypox-vaccine-doses.aspx#\">California’s health department laid out a rationale for a single shot plan\u003c/a> in the memo it sent to local agencies, noting that in the eradication of smallpox — a poxvirus genetically very similar to monkeypox — the first vaccine dose provided quick protection. Clinical trials in humans and animals measuring immunity from the Jynneos have produced similar results.\u003c/p>\n\u003cp>“While supplies remain scarce, vaccinators in California may offer first doses of JYNNEOS [sic] to additional persons at risk rather than retain inventory as second doses for immunocompetent persons, even if second doses are consequently administered at an interval greater than 28 days,” the memo said.\u003c/p>\n\u003cp>The health department said people who are immunocompromised are still eligible to received two doses. \u003cspan style=\"font-weight: 400\">\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"aside","attributes":{"named":{"postid":"news_11919070","hero":"https://ww2.kqed.org/app/uploads/sites/10/2022/07/RS57170_GettyImages-1401390462-qut.jpg","label":""},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/span>\u003c/p>\n\u003cp>UCSF’s Dr. Peter Chin-Hong told KQED in an email that it “is indeed safe not to get a second dose of the vaccine at 28 days, on time.”\u003c/p>\n\u003cp>\u003ca href=\"https://www.statnews.com/2022/07/15/nyc-one-dose-monkeypox-strategy-cdc-fda-warnings-against/\">New York, the United Kingdom and Canada are delaying the vaccine boosters\u003c/a>, too. Science magazine reported that \u003ca href=\"https://www.science.org/content/article/there-s-shortage-monkeypox-vaccine-could-one-dose-instead-two-suffice\">Paul Chaplin, an immunologist and CEO of Bavarian Nordic \u003c/a>— the company that manufactures the vaccine — also endorses the single dose plan.\u003c/p>\n\u003cp>\u003ca href=\"https://www.science.org/content/article/there-s-shortage-monkeypox-vaccine-could-one-dose-instead-two-suffice\">Federal scientists have cautioned that a single dose regime of vaccine hasn’t been studied\u003c/a> in an actual outbreak.\u003c/p>\n\u003cp>Jynneos is the only vaccine currently approved for the prevention of monkeypox in the United States.\u003c/p>\n\u003cp>San Francisco health officials say people, “especially those who have only received one dose,” should limit their risk of exposure to monkeypox before and after being vaccinated and second doses will be offered “once supply allows.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003c/p>\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/science/1979952/monkeypox-vaccines-california-and-fda-do-not-agree-on-how-to-stretch-meager-supply","authors":["11608"],"categories":["science_39","science_3890","science_40","science_4450"],"tags":["science_3643","science_1050","science_4417","science_197"],"featImg":"science_1979953","label":"source_science_1979952"},"science_1978903":{"type":"posts","id":"science_1978903","meta":{"index":"posts_1591205157","site":"science","id":"1978903","score":null,"sort":[1648679118000]},"guestAuthors":[],"slug":"the-omicron-subvariant-ba-2-has-been-in-the-bay-area-for-weeks-with-limited-impact","title":"The Omicron Subvariant BA.2 Has Been in the Bay Area for Weeks — With Limited Impact","publishDate":1648679118,"format":"audio","headTitle":"The Omicron Subvariant BA.2 Has Been in the Bay Area for Weeks — With Limited Impact | KQED","labelTerm":{},"content":"\u003cp>We’ve seen this play out before: Just as we start letting down our guard, the coronavirus mutates into another insidious version, wreaking havoc on our plans.\u003c/p>\n\u003cp>Cue BA.2, or \u003ca href=\"https://www.ama-assn.org/delivering-care/public-health/what-ba2-or-stealth-omicron-subvariant\">stealth omicron\u003c/a>.\u003c/p>\n\u003cp>Earlier this month when mask mandates started falling away, the subvariant struck parts of Europe and Asia, driving \u003ca href=\"https://www.cnbc.com/2022/03/23/omicrons-subvariant-bapoint2-could-spread-wildly-in-europe-epidemiologist.html\">unprecedented spikes\u003c/a>. Now, it’s traveling fast within the U.S.\u003c/p>\n\u003cp>BA.2 is both the dominant strain globally and, now, nationally, according to the \u003ca href=\"https://covid.cdc.gov/covid-data-tracker/#variant-proportions\" target=\"_blank\" rel=\"noopener noreferrer\">Centers for Disease Control and Prevention\u003c/a>, which credits more than half of U.S. cases to stealth omicron. Infections are edging up in parts of the Northeast, and \u003ca href=\"https://soe-wbe-pilot.wl.r.appspot.com/charts#page=overview\">recent wastewater data\u003c/a> from Palo Alto, Sunnyvale and Davis suggest BA.2 is starting to push cases up around Northern California — the first real sign that it’s having an impact in the region.\u003c/p>\n\u003cp>But the data does not suggest a repeat of last winter’s surge.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>“It’s not that sharp, dramatic increase from the beginning of the omicron wave,” said Marlene Wolfe of Emory University, one of the researchers who monitors wastewater sites across Northern California. “It’s something to watch, something to be careful of, something that we are glad we have this data to speak to.”\u003c/p>\n\u003ch2>Here’s what you need to know about BA.2 across California\u003c/h2>\n\u003cp>BA.2 is really good at its job: To date, it’s the most transmissible strain of the coronavirus. A \u003ca href=\"https://www.medrxiv.org/content/10.1101/2022.01.28.22270044v1\" target=\"_blank\" rel=\"noopener noreferrer\">Danish study\u003c/a> shows the virus spreads very quickly inside households, and a recent \u003ca href=\"https://www.medrxiv.org/content/10.1101/2022.03.26.22272984v1\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s2\">Swedish study\u003c/span>\u003c/a> shows that the viral loads are twice as high as the original omicron, which helps to explain why the latest strain of COVID-19 is furiously outcompeting its predecessor.\u003c/p>\n\u003cp>The good news is BA.2 does not appear to lead to more severe symptoms than the original omicron. Patients complain of cough, fatigue, congestion, dizziness and a runny nose.\u003c/p>\n\u003cp>“It’s not causing more intensive care hospital admissions in Europe,” said Dr. Susan Philip, San Francisco’s health officer. “[This is] a positive thing when we look at the characteristics of this virus.”\u003c/p>\n\u003ch2>How worried should we be?\u003c/h2>\n\u003cp>Not too worried, according to Dr. Bob Wachter, chair of UCSF’s department of medicine. “It might well lead to a small increase in cases, which we should watch carefully,” he said in an email. “It is unlikely to cause a major surge given the extent of [local] vax and infection-related immunity.”\u003c/p>\n\u003cp>That sentiment is shared by other local experts. UCSF epidemiologist Dr. George Rutherford suspects the impact in Northern California will be “relatively minor.” He estimates immunity coverage in the Bay Area is hovering around 90% due to high vaccine rates and the recent omicron wave, which left many people with natural immunity, at least in the short term. Those two factors wrap the region in a protective layer.\u003c/p>\n\u003cp>Rutherford points to what he sees as hopeful signs unfolding overseas. “Look at Western European data,” he said. “Cases are going up in some countries and not in others. A surge is not inevitable.”\u003c/p>\n\u003ch2>California cases continue to plummet\u003c/h2>\n\u003cp>It’s not time to panic. \u003ca href=\"https://covid19.ca.gov/?gclid=Cj0KCQjw3IqSBhCoARIsAMBkTb0HWWvfRHDNjPLxgEaX7PUdfx_IgCF7LJ77g3o8FIZ0HxBPJmRdTDIaAtYAEALw_wcB\">Cases across the state\u003c/a> have fallen about 32% over the past two weeks. Hospitalizations are not increasing and death rates continue to fall. Some regions are experiencing very slight upticks, but nothing concerning to public health officials.\u003c/p>\n\u003cp>Still, BA.2 poses the highest risk to anyone who is not vaccinated and did not catch omicron during the last surge. “The consequences for hospitalizations and deaths will be largely determined by how many people are vaccinated and how many older people are boosted,” said Bill Hanage, a Harvard epidemiologist.\u003c/p>\n\u003cp>This means children who are not yet old enough for a vaccine, as well as many disabled and immunocompromised people, remain at high risk.\u003c/p>\n\u003cp>If an actual surge were to form, regions with low vaccination rates would be the most vulnerable. In California that means rural areas and parts of the Central Valley.\u003c/p>\n\u003ch2>How can I protect myself?\u003c/h2>\n\u003cp>At this point California health officials are not recommending people make any course corrections to their daily lives. The state has a \u003ca href=\"https://files.covid19.ca.gov/pdf/smarter-plan--en.pdf\">road map for potential surges\u003c/a>, if the situation were to change.\u003c/p>\n\u003cp>“If we do start to see concerning increases in cases, increased severity or increasing hospitalization — we may need to reinstate some of our prior tools, things like masking,” California State Epidemiologist Dr. Erica Pan told KQED.\u003c/p>\n\u003cp>She recommends making sure you’re up to date on your vaccinations, and stocking up on \u003ca href=\"https://www.kqed.org/news/11901928/you-can-now-order-free-covid-at-home-tests-via-usps\"> home testing kits\u003c/a> to protect loved ones.\u003c/p>\n\u003ch2>Should I get a 4th dose if I’m over age 50?\u003c/h2>\n\u003cp>The U.S. Food and Drug Administration announced Tuesday that it has approved a fourth shot for people over 50. Until now the only people authorized for a fourth dose were those \u003ca href=\"https://www.nytimes.com/2022/01/09/health/immunocompromised-fourth-dose-booster.html\">with weakened immune systems\u003c/a>.\u003c/p>\n\u003cp>UCSF’s Wachter recommends a fourth shot for older adults who didn’t catch omicron in the last wave. This is especially critical if folks are engaging in riskier behaviors like eating inside restaurants. For those who caught the virus recently, Wachter suggests holding off on a fourth shot for a few months because a recent infection offers similar protection.\u003c/p>\n\u003cp>There’s \u003ca href=\"https://www.medrxiv.org/content/10.1101/2022.02.01.22270232v1.full.pdfre-pharmaceuticals/israeli-study-2nd-vaccine-booster-significantly-lowers-covid-death-rate-2022-03-27/\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s2\">compelling mortality data out of Israel\u003c/span>\u003c/a> suggesting a fourth shot dramatically lowers severe illness. However, the available data is preliminary and it’s not clear how long the benefits of a fourth dose will last.\u003c/p>\n\u003cp>https://twitter.com/Bob_Wachter/status/1508444987783929858?s=20&t=yr0py0rn9KRqRoEXy1Nb6Q\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>“I’m going to get it when I can,” \u003ca href=\"https://twitter.com/Bob_Wachter/status/1508446942887485440?s=20&t=yr0py0rn9KRqRoEXy1Nb6Q\">Wachter said in another tweet\u003c/a>. “I see the advantages of the 2nd boost as outweighing the small potential downside.”\u003c/p>\n\n","blocks":[],"excerpt":"BA.2 is the most transmissible strain of the coronavirus but does not appear to lead to more severe symptoms.","status":"publish","parent":0,"modified":1704846289,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":25,"wordCount":986},"headData":{"title":"The Omicron Subvariant BA.2 Has Been in the Bay Area for Weeks — With Limited Impact | KQED","description":"BA.2 is the most transmissible strain of the coronavirus but does not appear to lead to more severe symptoms.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"The Omicron Subvariant BA.2 Has Been in the Bay Area for Weeks — With Limited Impact","datePublished":"2022-03-30T22:25:18.000Z","dateModified":"2024-01-10T00:24:49.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"source":"Coronavirus","sticky":false,"excludeFromSiteSearch":"Include","path":"/science/1978903/the-omicron-subvariant-ba-2-has-been-in-the-bay-area-for-weeks-with-limited-impact","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>We’ve seen this play out before: Just as we start letting down our guard, the coronavirus mutates into another insidious version, wreaking havoc on our plans.\u003c/p>\n\u003cp>Cue BA.2, or \u003ca href=\"https://www.ama-assn.org/delivering-care/public-health/what-ba2-or-stealth-omicron-subvariant\">stealth omicron\u003c/a>.\u003c/p>\n\u003cp>Earlier this month when mask mandates started falling away, the subvariant struck parts of Europe and Asia, driving \u003ca href=\"https://www.cnbc.com/2022/03/23/omicrons-subvariant-bapoint2-could-spread-wildly-in-europe-epidemiologist.html\">unprecedented spikes\u003c/a>. Now, it’s traveling fast within the U.S.\u003c/p>\n\u003cp>BA.2 is both the dominant strain globally and, now, nationally, according to the \u003ca href=\"https://covid.cdc.gov/covid-data-tracker/#variant-proportions\" target=\"_blank\" rel=\"noopener noreferrer\">Centers for Disease Control and Prevention\u003c/a>, which credits more than half of U.S. cases to stealth omicron. Infections are edging up in parts of the Northeast, and \u003ca href=\"https://soe-wbe-pilot.wl.r.appspot.com/charts#page=overview\">recent wastewater data\u003c/a> from Palo Alto, Sunnyvale and Davis suggest BA.2 is starting to push cases up around Northern California — the first real sign that it’s having an impact in the region.\u003c/p>\n\u003cp>But the data does not suggest a repeat of last winter’s surge.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>“It’s not that sharp, dramatic increase from the beginning of the omicron wave,” said Marlene Wolfe of Emory University, one of the researchers who monitors wastewater sites across Northern California. “It’s something to watch, something to be careful of, something that we are glad we have this data to speak to.”\u003c/p>\n\u003ch2>Here’s what you need to know about BA.2 across California\u003c/h2>\n\u003cp>BA.2 is really good at its job: To date, it’s the most transmissible strain of the coronavirus. A \u003ca href=\"https://www.medrxiv.org/content/10.1101/2022.01.28.22270044v1\" target=\"_blank\" rel=\"noopener noreferrer\">Danish study\u003c/a> shows the virus spreads very quickly inside households, and a recent \u003ca href=\"https://www.medrxiv.org/content/10.1101/2022.03.26.22272984v1\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s2\">Swedish study\u003c/span>\u003c/a> shows that the viral loads are twice as high as the original omicron, which helps to explain why the latest strain of COVID-19 is furiously outcompeting its predecessor.\u003c/p>\n\u003cp>The good news is BA.2 does not appear to lead to more severe symptoms than the original omicron. Patients complain of cough, fatigue, congestion, dizziness and a runny nose.\u003c/p>\n\u003cp>“It’s not causing more intensive care hospital admissions in Europe,” said Dr. Susan Philip, San Francisco’s health officer. “[This is] a positive thing when we look at the characteristics of this virus.”\u003c/p>\n\u003ch2>How worried should we be?\u003c/h2>\n\u003cp>Not too worried, according to Dr. Bob Wachter, chair of UCSF’s department of medicine. “It might well lead to a small increase in cases, which we should watch carefully,” he said in an email. “It is unlikely to cause a major surge given the extent of [local] vax and infection-related immunity.”\u003c/p>\n\u003cp>That sentiment is shared by other local experts. UCSF epidemiologist Dr. George Rutherford suspects the impact in Northern California will be “relatively minor.” He estimates immunity coverage in the Bay Area is hovering around 90% due to high vaccine rates and the recent omicron wave, which left many people with natural immunity, at least in the short term. Those two factors wrap the region in a protective layer.\u003c/p>\n\u003cp>Rutherford points to what he sees as hopeful signs unfolding overseas. “Look at Western European data,” he said. “Cases are going up in some countries and not in others. A surge is not inevitable.”\u003c/p>\n\u003ch2>California cases continue to plummet\u003c/h2>\n\u003cp>It’s not time to panic. \u003ca href=\"https://covid19.ca.gov/?gclid=Cj0KCQjw3IqSBhCoARIsAMBkTb0HWWvfRHDNjPLxgEaX7PUdfx_IgCF7LJ77g3o8FIZ0HxBPJmRdTDIaAtYAEALw_wcB\">Cases across the state\u003c/a> have fallen about 32% over the past two weeks. Hospitalizations are not increasing and death rates continue to fall. Some regions are experiencing very slight upticks, but nothing concerning to public health officials.\u003c/p>\n\u003cp>Still, BA.2 poses the highest risk to anyone who is not vaccinated and did not catch omicron during the last surge. “The consequences for hospitalizations and deaths will be largely determined by how many people are vaccinated and how many older people are boosted,” said Bill Hanage, a Harvard epidemiologist.\u003c/p>\n\u003cp>This means children who are not yet old enough for a vaccine, as well as many disabled and immunocompromised people, remain at high risk.\u003c/p>\n\u003cp>If an actual surge were to form, regions with low vaccination rates would be the most vulnerable. In California that means rural areas and parts of the Central Valley.\u003c/p>\n\u003ch2>How can I protect myself?\u003c/h2>\n\u003cp>At this point California health officials are not recommending people make any course corrections to their daily lives. The state has a \u003ca href=\"https://files.covid19.ca.gov/pdf/smarter-plan--en.pdf\">road map for potential surges\u003c/a>, if the situation were to change.\u003c/p>\n\u003cp>“If we do start to see concerning increases in cases, increased severity or increasing hospitalization — we may need to reinstate some of our prior tools, things like masking,” California State Epidemiologist Dr. Erica Pan told KQED.\u003c/p>\n\u003cp>She recommends making sure you’re up to date on your vaccinations, and stocking up on \u003ca href=\"https://www.kqed.org/news/11901928/you-can-now-order-free-covid-at-home-tests-via-usps\"> home testing kits\u003c/a> to protect loved ones.\u003c/p>\n\u003ch2>Should I get a 4th dose if I’m over age 50?\u003c/h2>\n\u003cp>The U.S. Food and Drug Administration announced Tuesday that it has approved a fourth shot for people over 50. Until now the only people authorized for a fourth dose were those \u003ca href=\"https://www.nytimes.com/2022/01/09/health/immunocompromised-fourth-dose-booster.html\">with weakened immune systems\u003c/a>.\u003c/p>\n\u003cp>UCSF’s Wachter recommends a fourth shot for older adults who didn’t catch omicron in the last wave. This is especially critical if folks are engaging in riskier behaviors like eating inside restaurants. For those who caught the virus recently, Wachter suggests holding off on a fourth shot for a few months because a recent infection offers similar protection.\u003c/p>\n\u003cp>There’s \u003ca href=\"https://www.medrxiv.org/content/10.1101/2022.02.01.22270232v1.full.pdfre-pharmaceuticals/israeli-study-2nd-vaccine-booster-significantly-lowers-covid-death-rate-2022-03-27/\" target=\"_blank\" rel=\"noopener noreferrer\">\u003cspan class=\"s2\">compelling mortality data out of Israel\u003c/span>\u003c/a> suggesting a fourth shot dramatically lowers severe illness. However, the available data is preliminary and it’s not clear how long the benefits of a fourth dose will last.\u003c/p>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"singleTwitterStatus","attributes":{"named":{"id":"1508444987783929858"},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\n\u003cp>\u003c/p>\n\u003cp>“I’m going to get it when I can,” \u003ca href=\"https://twitter.com/Bob_Wachter/status/1508446942887485440?s=20&t=yr0py0rn9KRqRoEXy1Nb6Q\">Wachter said in another tweet\u003c/a>. “I see the advantages of the 2nd boost as outweighing the small potential downside.”\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/science/1978903/the-omicron-subvariant-ba-2-has-been-in-the-bay-area-for-weeks-with-limited-impact","authors":["11229"],"categories":["science_39","science_3890","science_40","science_4450"],"tags":["science_3643","science_4329","science_4368","science_1050","science_197"],"featImg":"science_1978921","label":"source_science_1978903"},"science_1946969":{"type":"posts","id":"science_1946969","meta":{"index":"posts_1591205157","site":"science","id":"1946969","score":null,"sort":[1567515664000]},"guestAuthors":[],"slug":"iphone-investigation-spurs-federal-testing-into-cellphone-radiation","title":"iPhone Investigation Spurs Federal Testing Into Cellphone Radiation","publishDate":1567515664,"format":"standard","headTitle":"iPhone Investigation Spurs Federal Testing Into Cellphone Radiation | KQED","labelTerm":{},"content":"\u003cp>When reporters from the \u003cem>Chicago Tribune\u003c/em> investigated cellphones for radiofrequency radiation, they found that the popular iPhone 7 measured over the legal safety limit and more than double what Apple reported to federal regulators from its own testing.\u003c/p>\n\u003cp>In response, the Federal Communications Commission, the agency that regulates cellphones, says it will now conduct its own testing.\u003c/p>\n\u003cp>Samuel Roe, an investigative reporter with the Tribune, \u003ca href=\"https://www.kqed.org/forum/2010101873014/fcc-to-investigate-cellphone-radiation-exposure\" target=\"_blank\" rel=\"noopener\">discussed\u003c/a> the investigation recently with host Michael Krasny on KQED’s Forum.\u003c/p>\n\u003cp>Roe got the idea to investigate cellphone radiation when his workplace issued him a new iPhone 7, one of the highest selling smartphones of all time.\u003c/p>\n\u003cp>“It came in the box and a nice wrapper,” he said. “I sent it to a lab in California — north of San Diego, San Marcos — and they followed all FCC guidelines and rules and tested the phone and it was admitting radiation that was higher than the legal limit, higher than what Apple reported to regulators.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The Tribune conducted its investigation in partnership with researchers at RF Exposure Lab, an FCC accredited lab in California. Researchers there have tested cellphones for 15 years. For this test, they measured 11 different cellphone models.\u003c/p>\n\u003cp>You can read their original report \u003ca href=\"https://www.chicagotribune.com/investigations/ct-cell-phone-radiation-testing-20190821-72qgu4nzlfda5kyuhteiieh4da-story.html\">here\u003c/a> and the methodology \u003ca href=\"https://www.kqed.org/forum/2010101873014/fcc-to-investigate-cellphone-radiation-exposure\">here\u003c/a>.\u003c/p>\n\u003cp>Below are excerpts of Roe’s answers, edited for length and clarity.\u003c/p>\n\u003cp>\u003cstrong>This Study Did Not Find An Increased Risk of Cancer Or Other Harms\u003c/strong>\u003c/p>\n\u003cp>We are talking about electromagnetic radiation. This is not like gamma radiation or X-ray radiation. This is further down the spectrum, so it’s less dangerous. But having said that, high readings from a cellphone can cause thermal damage. That is well documented. No one disputes that. That’s why there’s a safety limit.\u003c/p>\n\u003cp>[Note: According to the U.S. Food and Drug Administration’s \u003ca href=\"https://www.fda.gov/radiation-emitting-products/cell-phones/current-research-results\" target=\"_blank\" rel=\"noopener\">website\u003c/a>, most studies to date show no connection between health problems and exposure to radiofrequency fields from cellphones. But radiofrequency radiation can damage human tissue at high exposure levels.]\u003c/p>\n\u003cp>\u003cstrong>The Tribune Investigation Raises Questions About Federal Rules\u003c/strong>\u003c/p>\n\u003cp>The industry is, basically, on the honor system. They choose a lab. By federal rule, the manufacturer must test a phone to ensure that it complies with regulations before taking a new device to market. But the companies only have to test a single device in order to make millions of that phone.\u003c/p>\n\u003cp>We tested more phones than Apple tested before they put the iPhone 7 on the market. \u003cem> \u003c/em>\u003c/p>\n\u003cp>\u003cstrong>Federal Standards May Not Be Adequate\u003c/strong>\u003c/p>\n\u003cp>The standards are outdated and were issued back in the nineties, when people carried phones in different ways and used them less. I don’t think anybody anticipated how integral the smartphone would be to our lives. We use cellphones 24/7, especially kids. This year, Common Sense Media released a \u003ca href=\"https://www.commonsensemedia.org/research/The-New-Normal-Parents-Teens-and-Devices-Around-the-World\">study\u003c/a> that found that 29 percent of teenagers reported sleeping with their cellphone in bed at night\u003cem>.\u003c/em>\u003c/p>\n\u003cp>\u003cstrong>There is a Call for These Standards to be Modernized\u003c/strong>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Officials at the FCC said they are going to buy phones off the shelf, and test them against samples from the manufacturers. The agency shares regulatory responsibility for this issue with the FDA. If the feds find that the phones are out of compliance, they have the power to recall them.\u003c/p>\n\n","blocks":[],"excerpt":"The study raises questions about how well federal regulations are working. ","status":"publish","parent":0,"modified":1704848356,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":20,"wordCount":561},"headData":{"title":"iPhone Investigation Spurs Federal Testing Into Cellphone Radiation | KQED","description":"The study raises questions about how well federal regulations are working. ","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"iPhone Investigation Spurs Federal Testing Into Cellphone Radiation","datePublished":"2019-09-03T13:01:04.000Z","dateModified":"2024-01-10T00:59:16.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"source":"Health","sticky":false,"path":"/science/1946969/iphone-investigation-spurs-federal-testing-into-cellphone-radiation","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>When reporters from the \u003cem>Chicago Tribune\u003c/em> investigated cellphones for radiofrequency radiation, they found that the popular iPhone 7 measured over the legal safety limit and more than double what Apple reported to federal regulators from its own testing.\u003c/p>\n\u003cp>In response, the Federal Communications Commission, the agency that regulates cellphones, says it will now conduct its own testing.\u003c/p>\n\u003cp>Samuel Roe, an investigative reporter with the Tribune, \u003ca href=\"https://www.kqed.org/forum/2010101873014/fcc-to-investigate-cellphone-radiation-exposure\" target=\"_blank\" rel=\"noopener\">discussed\u003c/a> the investigation recently with host Michael Krasny on KQED’s Forum.\u003c/p>\n\u003cp>Roe got the idea to investigate cellphone radiation when his workplace issued him a new iPhone 7, one of the highest selling smartphones of all time.\u003c/p>\n\u003cp>“It came in the box and a nice wrapper,” he said. “I sent it to a lab in California — north of San Diego, San Marcos — and they followed all FCC guidelines and rules and tested the phone and it was admitting radiation that was higher than the legal limit, higher than what Apple reported to regulators.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The Tribune conducted its investigation in partnership with researchers at RF Exposure Lab, an FCC accredited lab in California. Researchers there have tested cellphones for 15 years. For this test, they measured 11 different cellphone models.\u003c/p>\n\u003cp>You can read their original report \u003ca href=\"https://www.chicagotribune.com/investigations/ct-cell-phone-radiation-testing-20190821-72qgu4nzlfda5kyuhteiieh4da-story.html\">here\u003c/a> and the methodology \u003ca href=\"https://www.kqed.org/forum/2010101873014/fcc-to-investigate-cellphone-radiation-exposure\">here\u003c/a>.\u003c/p>\n\u003cp>Below are excerpts of Roe’s answers, edited for length and clarity.\u003c/p>\n\u003cp>\u003cstrong>This Study Did Not Find An Increased Risk of Cancer Or Other Harms\u003c/strong>\u003c/p>\n\u003cp>We are talking about electromagnetic radiation. This is not like gamma radiation or X-ray radiation. This is further down the spectrum, so it’s less dangerous. But having said that, high readings from a cellphone can cause thermal damage. That is well documented. No one disputes that. That’s why there’s a safety limit.\u003c/p>\n\u003cp>[Note: According to the U.S. Food and Drug Administration’s \u003ca href=\"https://www.fda.gov/radiation-emitting-products/cell-phones/current-research-results\" target=\"_blank\" rel=\"noopener\">website\u003c/a>, most studies to date show no connection between health problems and exposure to radiofrequency fields from cellphones. But radiofrequency radiation can damage human tissue at high exposure levels.]\u003c/p>\n\u003cp>\u003cstrong>The Tribune Investigation Raises Questions About Federal Rules\u003c/strong>\u003c/p>\n\u003cp>The industry is, basically, on the honor system. They choose a lab. By federal rule, the manufacturer must test a phone to ensure that it complies with regulations before taking a new device to market. But the companies only have to test a single device in order to make millions of that phone.\u003c/p>\n\u003cp>We tested more phones than Apple tested before they put the iPhone 7 on the market. \u003cem> \u003c/em>\u003c/p>\n\u003cp>\u003cstrong>Federal Standards May Not Be Adequate\u003c/strong>\u003c/p>\n\u003cp>The standards are outdated and were issued back in the nineties, when people carried phones in different ways and used them less. I don’t think anybody anticipated how integral the smartphone would be to our lives. We use cellphones 24/7, especially kids. This year, Common Sense Media released a \u003ca href=\"https://www.commonsensemedia.org/research/The-New-Normal-Parents-Teens-and-Devices-Around-the-World\">study\u003c/a> that found that 29 percent of teenagers reported sleeping with their cellphone in bed at night\u003cem>.\u003c/em>\u003c/p>\n\u003cp>\u003cstrong>There is a Call for These Standards to be Modernized\u003c/strong>\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Officials at the FCC said they are going to buy phones off the shelf, and test them against samples from the manufacturers. The agency shares regulatory responsibility for this issue with the FDA. If the feds find that the phones are out of compliance, they have the power to recall them.\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/science/1946969/iphone-investigation-spurs-federal-testing-into-cellphone-radiation","authors":["11608"],"categories":["science_39","science_40"],"tags":["science_3840","science_1050","science_778"],"featImg":"science_1946972","label":"source_science_1946969"},"science_1943360":{"type":"posts","id":"science_1943360","meta":{"index":"posts_1591205157","site":"science","id":"1943360","score":null,"sort":[1560448994000]},"guestAuthors":[],"slug":"ketamine-cousin-approved-by-fda-for-depression-despite-warning-signs","title":"Ketamine Cousin Was Approved for Depression Despite Warning Signs","publishDate":1560448994,"format":"standard","headTitle":"Ketamine Cousin Was Approved for Depression Despite Warning Signs | KQED","labelTerm":{},"content":"\u003cp>Ketamine is a darling of combat medics and clubgoers, an anesthetic that can quiet your pain without suppressing breathing and a hallucinogenic that can get you high with little risk of a fatal overdose.\u003c/p>\n\u003cp>For some patients, it also has dwelled in the shadows of conventional medicine as a depression treatment — prescribed by their doctors, but not approved for that purpose by the federal agency responsible for determining which treatments are “safe and effective.”\u003c/p>\n\u003cp>That effectively changed in March, when the Food and Drug Administration approved a ketamine cousin called esketamine, taken as a nasal spray, for patients with intractable depression. With that, the esketamine nasal spray, under the brand name Spravato, was introduced as a miracle drug — announced in press releases, celebrated on the evening news and embraced by major health care providers \u003ca href=\"https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5220\" target=\"_blank\" rel=\"noopener\">like the Department of Veterans Affairs\u003c/a>.\u003c/p>\n\u003cp>The problem, critics say, is that the drug’s manufacturer, Janssen, provided the FDA at best modest evidence it worked and then only in limited trials. It presented no information about the safety of Spravato for long-term use beyond 60 weeks. And three patients who received the drug died by suicide during clinical trials, compared with none in the control group, raising red flags Janssen and the FDA dismissed.\u003c/p>\n\u003cp>The FDA, under political pressure to rapidly greenlight drugs that treat life-threatening conditions, approved it anyway. And, though Spravato’s appearance on the market was greeted with public applause, some deep misgivings were expressed at its day-long review meeting and in the agency’s own briefing materials, according to public recordings, documents and interviews with participants, KHN found.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Dr. Jess Fiedorowicz, director of the Mood Disorders Center at the University of Iowa and a member of the FDA advisory committee that reviewed the drug, described its benefit as “almost certainly exaggerated” after hearing the evidence.\u003c/p>\n\u003cp>Fiedorowicz said he expected at least a split decision by the committee. “And then it went strongly in favor, which surprised me,” he said in an interview.\u003c/p>\n\u003cp>Esketamine’s trajectory to approval shows — step by step — how drugmakers can take advantage of shortcuts in the FDA process with the agency’s blessing and maneuver through safety and efficacy reviews to bring a lucrative drug to market.\u003c/p>\n\u003cp>Step 1: In late 2013, Janssen got the FDA to designate esketamine a “breakthrough therapy” because it showed the potential to reverse depression rapidly — a holy grail for suicidal patients, such as those in an emergency room. That potential was based on a two-day study during which 30 patients were given esketamine intravenously.\u003c/p>\n\u003cp>\u003ca href=\"https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy\" target=\"_blank\" rel=\"noopener\">“Breakthrough therapy” status\u003c/a> puts drugs on a fast track to approval, with more frequent input from the FDA.\u003c/p>\n\u003cp>Step 2: But discussions between regulators and drug manufacturers can affect the amount and quality of evidence required by the agency. In the case of Spravato, they involved questions like, how many drugs must fail before a patient’s depression is considered intractable or “treatment-resistant”? And how many successful clinical trials are necessary for FDA approval?\u003c/p>\n\u003cp>Step 3: Any prior agreements can leave the FDA’s expert advisory committees hamstrung in reaching a verdict. Fiedorowicz abstained on Spravato because, though he considered Janssen’s study design flawed, the FDA had approved it.\u003c/p>\n\u003cp>The expert panel cleared the drug according to the evidence that the agency and Janssen had determined was sufficient. Dr. Matthew Rudorfer, an associate director at the National Institute of Mental Health, concluded that the “benefits outweighed the risks.” Explaining his “yes” vote, he said: “I think we’re all agreeing on the very important, and sometimes life-or-death, risk of inadequately treated depression that factored into my equation.”\u003c/p>\n\u003cp>But others who also voted “yes” were more explicit in their qualms. “I don’t think that we really understand what happens when you take this week after week for weeks and months and years,” said Steven Meisel, the system director of medication safety for Fairview Health Services based in Minneapolis.\u003c/p>\n\u003cp>\u003cstrong>A Nasal Spray Offers a Path to a Patent\u003c/strong>\u003c/p>\n\u003cp>Spravato is available only under supervision at a certified facility, like a doctor’s office, where patients must be monitored for at least two hours after taking the drug to watch for side effects like dizziness, detachment from reality and increased blood pressure, as well as to reduce the risk of abuse. Patients must take it with an oral antidepressant.\u003c/p>\n\u003cp>Despite those requirements, Janssen, part of Johnson & Johnson, defended its new offering. “Until the recent FDA approval of Spravato, health care providers haven’t had any new medication options,” Kristina Chang, a Janssen spokeswoman, wrote in an emailed statement.\u003c/p>\n\u003cp>Esketamine is the first new type of drug approved to treat severe depression in about three decades.\u003c/p>\n\u003cp>Although ketamine has been used off-label for years to treat depression and post-traumatic stress disorder, drugmakers saw little profit in doing the studies to prove to the FDA that it worked for that purpose. But a nasal spray of esketamine, which is derived from ketamine and (in some studies) more potent, could be patented as a new drug.\u003c/p>\n\u003cp>Although Spravato costs more than $4,700 for the first month of treatment (not including the cost of monitoring or the oral antidepressant), insurers are more likely to reimburse for Spravato than for ketamine, since the latter is not approved for depression.\u003c/p>\n\u003cp>Shortly before the committee began voting, a study participant identifying herself only as “Patient 20015525” said: “I am offering real-world proof of efficacy, and that is I am both alive and here today.”\u003c/p>\n\u003cp>The drug did not work “for the majority of people who took it,” Meisel, the medication safety expert, said in an interview. “But for a subset of those for whom it did work, it was dramatic.”\u003c/p>\n\u003cp>\u003cstrong>Concerns About Testing Precedents\u003c/strong>\u003c/p>\n\u003cp>Those considerations apparently helped outweigh several scientific red flags that committee members called out at the hearing.\u003c/p>\n\u003cp>Although the drug had gotten breakthrough status because of its potential for results within 24 hours, the trials were not persuasive enough for the FDA to label it “rapid-acting.”\u003c/p>\n\u003cp>The FDA typically requires that applicants provide at least two clinical trials demonstrating the drug’s efficacy, “\u003ca href=\"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-clinical-evidence-effectiveness-human-drug-and-biological-products\" target=\"_blank\" rel=\"noopener\">each convincing on its own.\u003c/a>” Janssen provided just one successful short-term, double-blind trial of esketamine. Two other trials it ran to test efficacy fell short.\u003c/p>\n\u003cp>To reach the two-trial threshold, the FDA broke its precedent for psychiatric drugs and allowed the company to count a trial conducted to study a different topic: relapse and remission trends. But, by definition, every patient in the trial had already taken and seen improvement from esketamine.\u003c/p>\n\u003cp>What’s more, that single positive efficacy trial showed just a 4-point improvement in depression symptoms compared with the placebo treatment on a 60-point scale some clinicians use to measure depression severity. Some committee members noted the trial wasn’t really blind since participants could recognize they were getting the drug from side effects like a temporary out-of-body sensation.\u003c/p>\n\u003cp>Finally, the FDA lowered the bar for “treatment-resistant depression.” Initially, for inclusion, trial participants would have had to have failed two classes of oral antidepressants.\u003c/p>\n\u003cp>Less than two years later, the FDA loosened that definition, saying a patient needed only to have taken two different pills, no matter the class.\u003c/p>\n\u003cp>Forty-nine of the 227 people who participated in Janssen’s only successful efficacy trial had failed just one class of oral antidepressants. “They weeded out the true treatment-resistant patients,” said Dr. Erick Turner, a former FDA reviewer who serves on the committee but did not attend the meeting.\u003c/p>\n\u003cp>Six participants died during the studies, three by suicide. Janssen and the FDA dismissed the deaths as unrelated to the drug, noting the low number and lack of a pattern among hundreds of participants. They also pointed out that suicidal behavior is associated with severe depression — even though those who had suicidal ideation with some intent to act in the previous six months, or a history of suicidal behavior in the previous year, were excluded from the studies.\u003c/p>\n\u003cp>In \u003ca href=\"https://ajp.psychiatryonline.org/doi/10.1176/appi.ajp.2019.19040423\" target=\"_blank\" rel=\"noopener\">a recent commentary in the American Journal of Psychiatry\u003c/a>, Dr. Alan Schatzberg, a Stanford University researcher who has studied ketamine, suggested there might be a link due to “a protracted withdrawal reaction, as has been reported with opioids,” since ketamine appears to interact with the brain’s opioid receptors.\u003c/p>\n\u003cp>Kim Witczak, the committee’s consumer representative, found Janssen’s conclusion about the suicides unsatisfying. “I just feel like it was kind of a quick brush-over,” Witczak said in an interview. She voted against the drug.\u003c/p>\n\u003cp>\u003cem>This story was produced by \u003ca href=\"http://khn.org/\" target=\"_blank\" rel=\"noopener\">Kaiser Health News\u003c/a>, an editorially independent program of the \u003ca href=\"https://www.kff.org/\" target=\"_blank\" rel=\"noopener\">Kaiser Family Foundation\u003c/a>.\u003c/em>\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>\u003ca href=\"http://www.kaiserhealthnews.org/\" target=\"_blank\" rel=\"noopener\">Kaiser Health News\u003c/a> (KHN) is a national health policy news service. It is an editorially independent program of the \u003ca href=\"http://www.kff.org/\" target=\"_blank\" rel=\"noopener\">Henry J. Kaiser Family Foundation\u003c/a> which is not affiliated with Kaiser Permanente.\u003c/em>\u003c/p>\n\n","blocks":[],"excerpt":"The Federal Drug Administration approved a ketamine cousin for patients with intractable depression. But the drug’s manufacturer provided the FDA with only modest evidence it worked.","status":"publish","parent":0,"modified":1704848599,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":38,"wordCount":1558},"headData":{"title":"Ketamine Cousin Was Approved for Depression Despite Warning Signs | KQED","description":"The Federal Drug Administration approved a ketamine cousin for patients with intractable depression. But the drug’s manufacturer provided the FDA with only modest evidence it worked.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Ketamine Cousin Was Approved for Depression Despite Warning Signs","datePublished":"2019-06-13T18:03:14.000Z","dateModified":"2024-01-10T01:03:19.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"source":"Kaiser Health News","sticky":false,"nprByline":"Emmarie Huetteman \u003cbr/> Kaiser Health News","path":"/science/1943360/ketamine-cousin-approved-by-fda-for-depression-despite-warning-signs","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Ketamine is a darling of combat medics and clubgoers, an anesthetic that can quiet your pain without suppressing breathing and a hallucinogenic that can get you high with little risk of a fatal overdose.\u003c/p>\n\u003cp>For some patients, it also has dwelled in the shadows of conventional medicine as a depression treatment — prescribed by their doctors, but not approved for that purpose by the federal agency responsible for determining which treatments are “safe and effective.”\u003c/p>\n\u003cp>That effectively changed in March, when the Food and Drug Administration approved a ketamine cousin called esketamine, taken as a nasal spray, for patients with intractable depression. With that, the esketamine nasal spray, under the brand name Spravato, was introduced as a miracle drug — announced in press releases, celebrated on the evening news and embraced by major health care providers \u003ca href=\"https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5220\" target=\"_blank\" rel=\"noopener\">like the Department of Veterans Affairs\u003c/a>.\u003c/p>\n\u003cp>The problem, critics say, is that the drug’s manufacturer, Janssen, provided the FDA at best modest evidence it worked and then only in limited trials. It presented no information about the safety of Spravato for long-term use beyond 60 weeks. And three patients who received the drug died by suicide during clinical trials, compared with none in the control group, raising red flags Janssen and the FDA dismissed.\u003c/p>\n\u003cp>The FDA, under political pressure to rapidly greenlight drugs that treat life-threatening conditions, approved it anyway. And, though Spravato’s appearance on the market was greeted with public applause, some deep misgivings were expressed at its day-long review meeting and in the agency’s own briefing materials, according to public recordings, documents and interviews with participants, KHN found.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Dr. Jess Fiedorowicz, director of the Mood Disorders Center at the University of Iowa and a member of the FDA advisory committee that reviewed the drug, described its benefit as “almost certainly exaggerated” after hearing the evidence.\u003c/p>\n\u003cp>Fiedorowicz said he expected at least a split decision by the committee. “And then it went strongly in favor, which surprised me,” he said in an interview.\u003c/p>\n\u003cp>Esketamine’s trajectory to approval shows — step by step — how drugmakers can take advantage of shortcuts in the FDA process with the agency’s blessing and maneuver through safety and efficacy reviews to bring a lucrative drug to market.\u003c/p>\n\u003cp>Step 1: In late 2013, Janssen got the FDA to designate esketamine a “breakthrough therapy” because it showed the potential to reverse depression rapidly — a holy grail for suicidal patients, such as those in an emergency room. That potential was based on a two-day study during which 30 patients were given esketamine intravenously.\u003c/p>\n\u003cp>\u003ca href=\"https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy\" target=\"_blank\" rel=\"noopener\">“Breakthrough therapy” status\u003c/a> puts drugs on a fast track to approval, with more frequent input from the FDA.\u003c/p>\n\u003cp>Step 2: But discussions between regulators and drug manufacturers can affect the amount and quality of evidence required by the agency. In the case of Spravato, they involved questions like, how many drugs must fail before a patient’s depression is considered intractable or “treatment-resistant”? And how many successful clinical trials are necessary for FDA approval?\u003c/p>\n\u003cp>Step 3: Any prior agreements can leave the FDA’s expert advisory committees hamstrung in reaching a verdict. Fiedorowicz abstained on Spravato because, though he considered Janssen’s study design flawed, the FDA had approved it.\u003c/p>\n\u003cp>The expert panel cleared the drug according to the evidence that the agency and Janssen had determined was sufficient. Dr. Matthew Rudorfer, an associate director at the National Institute of Mental Health, concluded that the “benefits outweighed the risks.” Explaining his “yes” vote, he said: “I think we’re all agreeing on the very important, and sometimes life-or-death, risk of inadequately treated depression that factored into my equation.”\u003c/p>\n\u003cp>But others who also voted “yes” were more explicit in their qualms. “I don’t think that we really understand what happens when you take this week after week for weeks and months and years,” said Steven Meisel, the system director of medication safety for Fairview Health Services based in Minneapolis.\u003c/p>\n\u003cp>\u003cstrong>A Nasal Spray Offers a Path to a Patent\u003c/strong>\u003c/p>\n\u003cp>Spravato is available only under supervision at a certified facility, like a doctor’s office, where patients must be monitored for at least two hours after taking the drug to watch for side effects like dizziness, detachment from reality and increased blood pressure, as well as to reduce the risk of abuse. Patients must take it with an oral antidepressant.\u003c/p>\n\u003cp>Despite those requirements, Janssen, part of Johnson & Johnson, defended its new offering. “Until the recent FDA approval of Spravato, health care providers haven’t had any new medication options,” Kristina Chang, a Janssen spokeswoman, wrote in an emailed statement.\u003c/p>\n\u003cp>Esketamine is the first new type of drug approved to treat severe depression in about three decades.\u003c/p>\n\u003cp>Although ketamine has been used off-label for years to treat depression and post-traumatic stress disorder, drugmakers saw little profit in doing the studies to prove to the FDA that it worked for that purpose. But a nasal spray of esketamine, which is derived from ketamine and (in some studies) more potent, could be patented as a new drug.\u003c/p>\n\u003cp>Although Spravato costs more than $4,700 for the first month of treatment (not including the cost of monitoring or the oral antidepressant), insurers are more likely to reimburse for Spravato than for ketamine, since the latter is not approved for depression.\u003c/p>\n\u003cp>Shortly before the committee began voting, a study participant identifying herself only as “Patient 20015525” said: “I am offering real-world proof of efficacy, and that is I am both alive and here today.”\u003c/p>\n\u003cp>The drug did not work “for the majority of people who took it,” Meisel, the medication safety expert, said in an interview. “But for a subset of those for whom it did work, it was dramatic.”\u003c/p>\n\u003cp>\u003cstrong>Concerns About Testing Precedents\u003c/strong>\u003c/p>\n\u003cp>Those considerations apparently helped outweigh several scientific red flags that committee members called out at the hearing.\u003c/p>\n\u003cp>Although the drug had gotten breakthrough status because of its potential for results within 24 hours, the trials were not persuasive enough for the FDA to label it “rapid-acting.”\u003c/p>\n\u003cp>The FDA typically requires that applicants provide at least two clinical trials demonstrating the drug’s efficacy, “\u003ca href=\"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-clinical-evidence-effectiveness-human-drug-and-biological-products\" target=\"_blank\" rel=\"noopener\">each convincing on its own.\u003c/a>” Janssen provided just one successful short-term, double-blind trial of esketamine. Two other trials it ran to test efficacy fell short.\u003c/p>\n\u003cp>To reach the two-trial threshold, the FDA broke its precedent for psychiatric drugs and allowed the company to count a trial conducted to study a different topic: relapse and remission trends. But, by definition, every patient in the trial had already taken and seen improvement from esketamine.\u003c/p>\n\u003cp>What’s more, that single positive efficacy trial showed just a 4-point improvement in depression symptoms compared with the placebo treatment on a 60-point scale some clinicians use to measure depression severity. Some committee members noted the trial wasn’t really blind since participants could recognize they were getting the drug from side effects like a temporary out-of-body sensation.\u003c/p>\n\u003cp>Finally, the FDA lowered the bar for “treatment-resistant depression.” Initially, for inclusion, trial participants would have had to have failed two classes of oral antidepressants.\u003c/p>\n\u003cp>Less than two years later, the FDA loosened that definition, saying a patient needed only to have taken two different pills, no matter the class.\u003c/p>\n\u003cp>Forty-nine of the 227 people who participated in Janssen’s only successful efficacy trial had failed just one class of oral antidepressants. “They weeded out the true treatment-resistant patients,” said Dr. Erick Turner, a former FDA reviewer who serves on the committee but did not attend the meeting.\u003c/p>\n\u003cp>Six participants died during the studies, three by suicide. Janssen and the FDA dismissed the deaths as unrelated to the drug, noting the low number and lack of a pattern among hundreds of participants. They also pointed out that suicidal behavior is associated with severe depression — even though those who had suicidal ideation with some intent to act in the previous six months, or a history of suicidal behavior in the previous year, were excluded from the studies.\u003c/p>\n\u003cp>In \u003ca href=\"https://ajp.psychiatryonline.org/doi/10.1176/appi.ajp.2019.19040423\" target=\"_blank\" rel=\"noopener\">a recent commentary in the American Journal of Psychiatry\u003c/a>, Dr. Alan Schatzberg, a Stanford University researcher who has studied ketamine, suggested there might be a link due to “a protracted withdrawal reaction, as has been reported with opioids,” since ketamine appears to interact with the brain’s opioid receptors.\u003c/p>\n\u003cp>Kim Witczak, the committee’s consumer representative, found Janssen’s conclusion about the suicides unsatisfying. “I just feel like it was kind of a quick brush-over,” Witczak said in an interview. She voted against the drug.\u003c/p>\n\u003cp>\u003cem>This story was produced by \u003ca href=\"http://khn.org/\" target=\"_blank\" rel=\"noopener\">Kaiser Health News\u003c/a>, an editorially independent program of the \u003ca href=\"https://www.kff.org/\" target=\"_blank\" rel=\"noopener\">Kaiser Family Foundation\u003c/a>.\u003c/em>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>\u003ca href=\"http://www.kaiserhealthnews.org/\" target=\"_blank\" rel=\"noopener\">Kaiser Health News\u003c/a> (KHN) is a national health policy news service. It is an editorially independent program of the \u003ca href=\"http://www.kff.org/\" target=\"_blank\" rel=\"noopener\">Henry J. Kaiser Family Foundation\u003c/a> which is not affiliated with Kaiser Permanente.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/science/1943360/ketamine-cousin-approved-by-fda-for-depression-despite-warning-signs","authors":["byline_science_1943360"],"categories":["science_39","science_3890","science_40"],"tags":["science_1050","science_3838"],"featImg":"science_1943363","label":"source_science_1943360"},"science_1938753":{"type":"posts","id":"science_1938753","meta":{"index":"posts_1591205157","site":"science","id":"1938753","score":null,"sort":[1551898675000]},"guestAuthors":[],"slug":"fda-approves-first-major-depression-treatment-in-decades","title":"FDA Approves First Major Depression Treatment in Decades","publishDate":1551898675,"format":"standard","headTitle":"FDA Approves First Major Depression Treatment in Decades | KQED","labelTerm":{},"content":"\u003cp>The Food and Drug Administration on Tuesday approved esketamine, the first major depression treatment to hit the U.S. market in decades and a new option for patients who haven’t responded to existing therapies.\u003c/p>\n\u003cp>Esketamine — developed by Johnson & Johnson and delivered as a nasal spray — was tested in combination with oral antidepressants in patients with what’s known as treatment-resistant depression. The drug is related to ketamine, a common anesthetic that’s sometimes misused recreationally. Many experts have hailed esketamine as a critical option for patients in dire need of new treatments — particularly because it might \u003ca href=\"https://www.statnews.com/2018/07/03/fast-acting-antidepressants-clinical-trials/\" target=\"_blank\" rel=\"noopener\">work faster\u003c/a> than existing antidepressants.[contextly_sidebar id=”wpaMiTiEavHYfZeJHTCfjFSpMgrPcXap”]\u003c/p>\n\u003cp>“The unmet need is really huge,” said Dr. Husseini Manji, the global head of neuroscience therapeutics at Janssen, the subsidiary of Johnson & Johnson that developed the drug, which will be called Spravato.\u003c/p>\n\u003cp>Janssen said the cost of the treatment will depend on the dose used per session and how many sessions a person will need, both of which can vary. The wholesale acquisition cost: between $590 and $885 per treatment session. That means the wholesale acquisition cost for the first month of treatment — which includes two sessions a week — will range from $4,720 to $6,785.\u003c/p>\n\u003cp>But an approval — and subsequently, anticipated insurance coverage for esketamine — is welcome news for the growing number of patients who have \u003ca href=\"https://www.statnews.com/2018/09/24/ketamine-clinics-severe-depression-treatment/\" target=\"_blank\" rel=\"noopener\">paid thousands of dollars\u003c/a> out of pocket in recent years to receive off-label infusions of ketamine as a treatment for depression.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The drug’s labeling will include a warning that patients who take esketamine are at risk for sedation and issues with attention, judgement, and thinking. It will also warn that there is a risk of misuse, abuse, and suicidal thoughts after taking esketamine. Patients who receive the drug will have to be monitored for at least two hours every time they get esketamine.\u003c/p>\n\u003cp>Johnson & Johnson submitted five Phase 3 studies on the drug: three-short term studies, one maintenance study, and a long-term safety study. Aside from the safety study, two of those turned up positive, clinically significant results. One was a randomized trial in adults under age 65 with treatment-resistant depression who were started on an oral antidepressant and esketamine. After a month, roughly 70 percent of patients who received the treatment responded, compared to just over half in a placebo group. An improvement of 50 percent or more on a common depression rating scale was seen as a successful response.\u003c/p>\n\u003cp>The other positive study was a maintenance-of-effect study, in which participants who responded to esketamine in one of the short-term studies were randomly assigned to either keep taking it or be switched to a placebo. The FDA generally wants to see two successful studies for approval — but historically, withdrawal studies haven’t counted toward that total.\u003c/p>\n\u003cp>But the FDA said the evidence — and input from external advisers — played a role in the decision to approve the drug.\u003c/p>\n\u003cp>“Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment,” Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.\u003c/p>\n\u003cp>Not all experts are convinced there was enough data to approve esketamine yet.\u003c/p>\n\u003cp>“The threshold has been two adequate and well-controlled trials. In this case, they only got one,” Dr. Erick Turner, a psychiatrist at Oregon Health and Science University, told STAT in an interview last month. Turner serves on the FDA advisory committee that recommended last month that the FDA approve esketamine, but didn’t take part in that meeting.\u003c/p>\n\u003cp>The committee emphasized the need for a robust strategy to prevent diversion and misuse, given that ketamine is commonly abused. Ketamine is a combination of two enantiomers, or mirror image molecules. Esketamine is what’s known as the s-enantiomer. But the experts generally agreed that the risk of abuse with esketamine seems to be low.\u003c/p>\n\u003cp>“There will be all kinds of monitoring to make sure the drug doesn’t get diverted,” Manji said. That includes strict distribution requirements and a suspicious order monitoring program.\u003c/p>\n\u003cp>The FDA has also expressed concern that patients could be harmed if they experience dissociation, or an out-of-body experience that can leave people less aware of their surroundings. In briefing documents submitted before the advisory committee meeting, the agency also noted six deaths — including three suicides — among patients who were taking the drug. But FDA reviewers said that given that the patients had severe illnesses and there wasn’t a pattern seen in the deaths, it’s “difficult to consider these deaths as drug related.”\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Johnson & Johnson is also testing esketamine as a treatment for people with depression who are at risk of suicide, and is expected to release results from a study on suicidal patients this year. Allergan is also in the late stages of testing an experimental, fast-acting antidepressant called rapastinel. An Allergan spokesperson said that the company anticipates that the need to monitor patients and restrict activities after rapastinel will be “minimal” compared to the requirements for esketamine. The company also said there seems to be a lower rate of dissociative effects with rapastinel. The drug is being tested alone, in combination with other treatments for major depression, and in patients with depression who are at risk of suicide.\u003c/p>\n\n","blocks":[],"excerpt":"On Tuesday, the Food and Drug Administration approved esketamine, the first major depression treatment to hit the U.S. market in decades.","status":"publish","parent":0,"modified":1704848819,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":18,"wordCount":963},"headData":{"title":"FDA Approves First Major Depression Treatment in Decades | KQED","description":"On Tuesday, the Food and Drug Administration approved esketamine, the first major depression treatment to hit the U.S. market in decades.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"FDA Approves First Major Depression Treatment in Decades","datePublished":"2019-03-06T18:57:55.000Z","dateModified":"2024-01-10T01:06:59.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"source":"Health","sticky":false,"nprByline":"Megan Thielking\u003c/br>STAT","path":"/science/1938753/fda-approves-first-major-depression-treatment-in-decades","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>The Food and Drug Administration on Tuesday approved esketamine, the first major depression treatment to hit the U.S. market in decades and a new option for patients who haven’t responded to existing therapies.\u003c/p>\n\u003cp>Esketamine — developed by Johnson & Johnson and delivered as a nasal spray — was tested in combination with oral antidepressants in patients with what’s known as treatment-resistant depression. The drug is related to ketamine, a common anesthetic that’s sometimes misused recreationally. Many experts have hailed esketamine as a critical option for patients in dire need of new treatments — particularly because it might \u003ca href=\"https://www.statnews.com/2018/07/03/fast-acting-antidepressants-clinical-trials/\" target=\"_blank\" rel=\"noopener\">work faster\u003c/a> than existing antidepressants.\u003c/p>\u003cp>\u003c/p>\u003cp>\u003c/p>\n\u003cp>“The unmet need is really huge,” said Dr. Husseini Manji, the global head of neuroscience therapeutics at Janssen, the subsidiary of Johnson & Johnson that developed the drug, which will be called Spravato.\u003c/p>\n\u003cp>Janssen said the cost of the treatment will depend on the dose used per session and how many sessions a person will need, both of which can vary. The wholesale acquisition cost: between $590 and $885 per treatment session. That means the wholesale acquisition cost for the first month of treatment — which includes two sessions a week — will range from $4,720 to $6,785.\u003c/p>\n\u003cp>But an approval — and subsequently, anticipated insurance coverage for esketamine — is welcome news for the growing number of patients who have \u003ca href=\"https://www.statnews.com/2018/09/24/ketamine-clinics-severe-depression-treatment/\" target=\"_blank\" rel=\"noopener\">paid thousands of dollars\u003c/a> out of pocket in recent years to receive off-label infusions of ketamine as a treatment for depression.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The drug’s labeling will include a warning that patients who take esketamine are at risk for sedation and issues with attention, judgement, and thinking. It will also warn that there is a risk of misuse, abuse, and suicidal thoughts after taking esketamine. Patients who receive the drug will have to be monitored for at least two hours every time they get esketamine.\u003c/p>\n\u003cp>Johnson & Johnson submitted five Phase 3 studies on the drug: three-short term studies, one maintenance study, and a long-term safety study. Aside from the safety study, two of those turned up positive, clinically significant results. One was a randomized trial in adults under age 65 with treatment-resistant depression who were started on an oral antidepressant and esketamine. After a month, roughly 70 percent of patients who received the treatment responded, compared to just over half in a placebo group. An improvement of 50 percent or more on a common depression rating scale was seen as a successful response.\u003c/p>\n\u003cp>The other positive study was a maintenance-of-effect study, in which participants who responded to esketamine in one of the short-term studies were randomly assigned to either keep taking it or be switched to a placebo. The FDA generally wants to see two successful studies for approval — but historically, withdrawal studies haven’t counted toward that total.\u003c/p>\n\u003cp>But the FDA said the evidence — and input from external advisers — played a role in the decision to approve the drug.\u003c/p>\n\u003cp>“Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment,” Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.\u003c/p>\n\u003cp>Not all experts are convinced there was enough data to approve esketamine yet.\u003c/p>\n\u003cp>“The threshold has been two adequate and well-controlled trials. In this case, they only got one,” Dr. Erick Turner, a psychiatrist at Oregon Health and Science University, told STAT in an interview last month. Turner serves on the FDA advisory committee that recommended last month that the FDA approve esketamine, but didn’t take part in that meeting.\u003c/p>\n\u003cp>The committee emphasized the need for a robust strategy to prevent diversion and misuse, given that ketamine is commonly abused. Ketamine is a combination of two enantiomers, or mirror image molecules. Esketamine is what’s known as the s-enantiomer. But the experts generally agreed that the risk of abuse with esketamine seems to be low.\u003c/p>\n\u003cp>“There will be all kinds of monitoring to make sure the drug doesn’t get diverted,” Manji said. That includes strict distribution requirements and a suspicious order monitoring program.\u003c/p>\n\u003cp>The FDA has also expressed concern that patients could be harmed if they experience dissociation, or an out-of-body experience that can leave people less aware of their surroundings. In briefing documents submitted before the advisory committee meeting, the agency also noted six deaths — including three suicides — among patients who were taking the drug. But FDA reviewers said that given that the patients had severe illnesses and there wasn’t a pattern seen in the deaths, it’s “difficult to consider these deaths as drug related.”\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Johnson & Johnson is also testing esketamine as a treatment for people with depression who are at risk of suicide, and is expected to release results from a study on suicidal patients this year. Allergan is also in the late stages of testing an experimental, fast-acting antidepressant called rapastinel. An Allergan spokesperson said that the company anticipates that the need to monitor patients and restrict activities after rapastinel will be “minimal” compared to the requirements for esketamine. The company also said there seems to be a lower rate of dissociative effects with rapastinel. The drug is being tested alone, in combination with other treatments for major depression, and in patients with depression who are at risk of suicide.\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/science/1938753/fda-approves-first-major-depression-treatment-in-decades","authors":["byline_science_1938753"],"categories":["science_39","science_16","science_3890","science_40"],"tags":["science_1050","science_3838","science_249"],"featImg":"science_1938763","label":"source_science_1938753"}},"programsReducer":{"possible":{"id":"possible","title":"Possible","info":"Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. Together in Possible, Hoffman and Finger lead enlightening discussions about building a brighter collective future. The show features interviews with visionary guests like Trevor Noah, Sam Altman and Janette Sadik-Khan. Possible paints an optimistic portrait of the world we can create through science, policy, business, art and our shared humanity. It asks: What if everything goes right for once? How can we get there? Each episode also includes a short fiction story generated by advanced AI GPT-4, serving as a thought-provoking springboard to speculate how humanity could leverage technology for good.","airtime":"SUN 2pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Possible-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.possible.fm/","meta":{"site":"news","source":"Possible"},"link":"/radio/program/possible","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/possible/id1677184070","spotify":"https://open.spotify.com/show/730YpdUSNlMyPQwNnyjp4k"}},"1a":{"id":"1a","title":"1A","info":"1A is home to the national conversation. 1A brings on great guests and frames the best debate in ways that make you think, share and engage.","airtime":"MON-THU 11pm-12am","imageSrc":"https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/1a.jpg","officialWebsiteLink":"https://the1a.org/","meta":{"site":"news","source":"npr"},"link":"/radio/program/1a","subscribe":{"npr":"https://rpb3r.app.goo.gl/RBrW","apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?s=143441&mt=2&id=1188724250&at=11l79Y&ct=nprdirectory","tuneIn":"https://tunein.com/radio/1A-p947376/","rss":"https://feeds.npr.org/510316/podcast.xml"}},"all-things-considered":{"id":"all-things-considered","title":"All Things Considered","info":"Every weekday, \u003cem>All Things Considered\u003c/em> hosts Robert Siegel, Audie Cornish, Ari Shapiro, and Kelly McEvers present the program's trademark mix of news, interviews, commentaries, reviews, and offbeat features. Michel Martin hosts on the weekends.","airtime":"MON-FRI 1pm-2pm, 4:30pm-6:30pm\u003cbr />SAT-SUN 5pm-6pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/All-Things-Considered-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.npr.org/programs/all-things-considered/","meta":{"site":"news","source":"npr"},"link":"/radio/program/all-things-considered"},"american-suburb-podcast":{"id":"american-suburb-podcast","title":"American Suburb: The Podcast","tagline":"The flip side of gentrification, told through one town","info":"Gentrification is changing cities across America, forcing people from neighborhoods they have long called home. Call them the displaced. Now those priced out of the Bay Area are looking for a better life in an unlikely place. American Suburb follows this migration to one California town along the Delta, 45 miles from San Francisco. But is this once sleepy suburb ready for them?","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/American-Suburb-Podcast-Tile-703x703-1.jpg","officialWebsiteLink":"/news/series/american-suburb-podcast","meta":{"site":"news","source":"kqed","order":"13"},"link":"/news/series/american-suburb-podcast/","subscribe":{"npr":"https://rpb3r.app.goo.gl/RBrW","apple":"https://itunes.apple.com/WebObjects/MZStore.woa/wa/viewPodcast?mt=2&id=1287748328","tuneIn":"https://tunein.com/radio/American-Suburb-p1086805/","rss":"https://ww2.kqed.org/news/series/american-suburb-podcast/feed/podcast","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkMzMDExODgxNjA5"}},"baycurious":{"id":"baycurious","title":"Bay Curious","tagline":"Exploring the Bay Area, one question at a time","info":"KQED’s new podcast, Bay Curious, gets to the bottom of the mysteries — both profound and peculiar — that give the Bay Area its unique identity. And we’ll do it with your help! You ask the questions. You decide what Bay Curious investigates. And you join us on the journey to find the answers.","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Bay-Curious-Podcast-Tile-703x703-1.jpg","imageAlt":"\"KQED Bay Curious","officialWebsiteLink":"/news/series/baycurious","meta":{"site":"news","source":"kqed","order":"4"},"link":"/podcasts/baycurious","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/bay-curious/id1172473406","npr":"https://www.npr.org/podcasts/500557090/bay-curious","rss":"https://ww2.kqed.org/news/category/bay-curious-podcast/feed/podcast","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93dzIua3FlZC5vcmcvbmV3cy9jYXRlZ29yeS9iYXktY3VyaW91cy1wb2RjYXN0L2ZlZWQvcG9kY2FzdA","stitcher":"https://www.stitcher.com/podcast/kqed/bay-curious","spotify":"https://open.spotify.com/show/6O76IdmhixfijmhTZLIJ8k"}},"bbc-world-service":{"id":"bbc-world-service","title":"BBC World Service","info":"The day's top stories from BBC News compiled twice daily in the week, once at weekends.","airtime":"MON-FRI 9pm-10pm, TUE-FRI 1am-2am","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/BBC-World-Service-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.bbc.co.uk/sounds/play/live:bbc_world_service","meta":{"site":"news","source":"BBC World Service"},"link":"/radio/program/bbc-world-service","subscribe":{"apple":"https://itunes.apple.com/us/podcast/global-news-podcast/id135067274?mt=2","tuneIn":"https://tunein.com/radio/BBC-World-Service-p455581/","rss":"https://podcasts.files.bbci.co.uk/p02nq0gn.rss"}},"code-switch-life-kit":{"id":"code-switch-life-kit","title":"Code Switch / Life Kit","info":"\u003cem>Code Switch\u003c/em>, which listeners will hear in the first part of the hour, has fearless and much-needed conversations about race. Hosted by journalists of color, the show tackles the subject of race head-on, exploring how it impacts every part of society — from politics and pop culture to history, sports and more.\u003cbr />\u003cbr />\u003cem>Life Kit\u003c/em>, which will be in the second part of the hour, guides you through spaces and feelings no one prepares you for — from finances to mental health, from workplace microaggressions to imposter syndrome, from relationships to parenting. The show features experts with real world experience and shares their knowledge. 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You can also visit the MindShift website for episodes and supplemental blog posts or tweet us \u003ca href=\"https://twitter.com/MindShiftKQED\">@MindShiftKQED\u003c/a> or visit us at \u003ca href=\"/mindshift\">MindShift.KQED.org\u003c/a>","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Mindshift-Podcast-Tile-703x703-1.jpg","imageAlt":"KQED MindShift: How We Will Learn","officialWebsiteLink":"/mindshift/","meta":{"site":"news","source":"kqed","order":"2"},"link":"/podcasts/mindshift","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/mindshift-podcast/id1078765985","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5tZWdhcGhvbmUuZm0vS1FJTkM1NzY0NjAwNDI5","npr":"https://www.npr.org/podcasts/464615685/mind-shift-podcast","stitcher":"https://www.stitcher.com/podcast/kqed/stories-teachers-share","spotify":"https://open.spotify.com/show/0MxSpNYZKNprFLCl7eEtyx"}},"morning-edition":{"id":"morning-edition","title":"Morning Edition","info":"\u003cem>Morning Edition\u003c/em> takes listeners around the country and the world with multi-faceted stories and commentaries every weekday. Hosts Steve Inskeep, David Greene and Rachel Martin bring you the latest breaking news and features to prepare you for the day.","airtime":"MON-FRI 3am-9am","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Morning-Edition-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.npr.org/programs/morning-edition/","meta":{"site":"news","source":"npr"},"link":"/radio/program/morning-edition"},"onourwatch":{"id":"onourwatch","title":"On Our Watch","tagline":"Police secrets, unsealed","info":"For decades, the process for how police police themselves has been inconsistent – if not opaque. In some states, like California, these proceedings were completely hidden. After a new police transparency law unsealed scores of internal affairs files, our reporters set out to examine these cases and the shadow world of police discipline. On Our Watch brings listeners into the rooms where officers are questioned and witnesses are interrogated to find out who this system is really protecting. Is it the officers, or the public they've sworn to serve?","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/On-Our-Watch-Podcast-Tile-703x703-1.jpg","imageAlt":"On Our Watch from NPR and KQED","officialWebsiteLink":"/podcasts/onourwatch","meta":{"site":"news","source":"kqed","order":"1"},"link":"/podcasts/onourwatch","subscribe":{"apple":"https://podcasts.apple.com/podcast/id1567098962","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5ucHIub3JnLzUxMDM2MC9wb2RjYXN0LnhtbD9zYz1nb29nbGVwb2RjYXN0cw","npr":"https://rpb3r.app.goo.gl/onourwatch","spotify":"https://open.spotify.com/show/0OLWoyizopu6tY1XiuX70x","tuneIn":"https://tunein.com/radio/On-Our-Watch-p1436229/","stitcher":"https://www.stitcher.com/show/on-our-watch","rss":"https://feeds.npr.org/510360/podcast.xml"}},"on-the-media":{"id":"on-the-media","title":"On The Media","info":"Our weekly podcast explores how the media 'sausage' is made, casts an incisive eye on fluctuations in the marketplace of ideas, and examines threats to the freedom of information and expression in America and abroad. For one hour a week, the show tries to lift the veil from the process of \"making media,\" especially news media, because it's through that lens that we see the world and the world sees us","airtime":"SUN 2pm-3pm, MON 12am-1am","imageSrc":"https://ww2.kqed.org/radio/wp-content/uploads/sites/50/2018/04/onTheMedia.png","officialWebsiteLink":"https://www.wnycstudios.org/shows/otm","meta":{"site":"news","source":"wnyc"},"link":"/radio/program/on-the-media","subscribe":{"apple":"https://itunes.apple.com/us/podcast/on-the-media/id73330715?mt=2","tuneIn":"https://tunein.com/radio/On-the-Media-p69/","rss":"http://feeds.wnyc.org/onthemedia"}},"our-body-politic":{"id":"our-body-politic","title":"Our Body Politic","info":"Presented by KQED, KCRW and KPCC, and created and hosted by award-winning journalist Farai Chideya, Our Body Politic is unapologetically centered on reporting on not just how women of color experience the major political events of today, but how they’re impacting those very issues.","airtime":"SAT 6pm-7pm, SUN 1am-2am","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Our-Body-Politic-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://our-body-politic.simplecast.com/","meta":{"site":"news","source":"kcrw"},"link":"/radio/program/our-body-politic","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/our-body-politic/id1533069868","google":"https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zaW1wbGVjYXN0LmNvbS9feGFQaHMxcw","spotify":"https://open.spotify.com/show/4ApAiLT1kV153TttWAmqmc","rss":"https://feeds.simplecast.com/_xaPhs1s","tuneIn":"https://tunein.com/podcasts/News--Politics-Podcasts/Our-Body-Politic-p1369211/"}},"pbs-newshour":{"id":"pbs-newshour","title":"PBS NewsHour","info":"Analysis, background reports and updates from the PBS NewsHour putting today's news in context.","airtime":"MON-FRI 3pm-4pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/PBS-News-Hour-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.pbs.org/newshour/","meta":{"site":"news","source":"pbs"},"link":"/radio/program/pbs-newshour","subscribe":{"apple":"https://itunes.apple.com/us/podcast/pbs-newshour-full-show/id394432287?mt=2","tuneIn":"https://tunein.com/radio/PBS-NewsHour---Full-Show-p425698/","rss":"https://www.pbs.org/newshour/feeds/rss/podcasts/show"}},"perspectives":{"id":"perspectives","title":"Perspectives","tagline":"KQED's series of of daily listener commentaries since 1991","info":"KQED's series of of daily listener commentaries since 1991.","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Perspectives-Podcast-Tile-703x703-1.jpg","officialWebsiteLink":"/perspectives/","meta":{"site":"radio","source":"kqed","order":"15"},"link":"/perspectives","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/id73801135","npr":"https://www.npr.org/podcasts/432309616/perspectives","rss":"https://ww2.kqed.org/perspectives/category/perspectives/feed/","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93dzIua3FlZC5vcmcvcGVyc3BlY3RpdmVzL2NhdGVnb3J5L3BlcnNwZWN0aXZlcy9mZWVkLw"}},"planet-money":{"id":"planet-money","title":"Planet Money","info":"The economy explained. 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