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"disqusTitle": "Feds Seize Smallpox Vaccine as FDA Targets 'Deceitful' Stem Cell Clinics",
"title": "Feds Seize Smallpox Vaccine as FDA Targets 'Deceitful' Stem Cell Clinics",
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"content": "\u003cp>Federal authorities raided a California stem cell clinic and seized a smallpox vaccine that is reserved only for the military and high-risk populations, as the Food and Drug Administration expressed “serious concerns” about how the clinic obtained access to the vaccine at all.\u003c/p>\n\u003cp class=\"danger-zone\">The U.S. Marshals Service seized five vials of the smallpox vaccine, which is not commercially available, the FDA \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573427.htm\" target=\"_blank\" rel=\"noopener noreferrer\">announced\u003c/a> Monday. Four of the vials — which each hold 100 vaccine doses — were unused, but a portion of the fifth vial had been used.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I especially won’t allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.'\u003ccite> FDA Commissioner Scott Gottlieb\u003c/cite>\u003c/aside>\n\u003cp>The treatment mixed some of the vaccine with stem cells taken from a patient to create an injectable — and unproven and unregulated — cancer treatment that was targeted directly at the patient’s tumors, the FDA said. The FDA, which learned of the treatment after inspections, said the injection could have caused inflammation and swelling of the heart.\u003c/p>\n\u003cp>The treatment belonged to San Diego-based company StemImmune Inc., and was given at California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills. U.S. marshals seized the product on Friday.\u003c/p>\n\u003cp>“The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work,” FDA Commissioner Scott Gottlieb said in a statement. “I especially won’t allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.”\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>A complaint filed in federal court indicates the vials were shipped from outside California but does not provide more detail on the origin. StemImmune also filed \u003ca href=\"http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=2&p=1&f=G&l=50&d=PG01&S1=Stemimmune.AANM.&OS=AANM/Stemimmune&RS=AANM/Stemimmune\" target=\"_blank\" rel=\"noopener noreferrer\">a patent application\u003c/a> in February describing “the use of smallpox vaccine to induce an effective anti-tumor immune response.”\u003c/p>\n\u003cp>The type of vaccine that was seized \u003ca href=\"https://www.cdc.gov/smallpox/vaccine-basics/index.html\" target=\"_blank\" rel=\"noopener noreferrer\">is made \u003c/a>from a virus similar to smallpox, but it does not contain smallpox virus and cannot give anyone smallpox, according to the Centers for Disease Control and Prevention.\u003c/p>\n\u003cp>Also Monday, the FDA announced it had sent \u003ca href=\"https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm573187.htm\" target=\"_blank\" rel=\"noopener noreferrer\">a warning letter\u003c/a> to a Florida stem cell clinic where a 2015 procedure led three women to go legally blind, according \u003ca href=\"https://www.statnews.com/2017/03/15/stem-cell-patients-blind-macular-degeneration/\">to a March study\u003c/a> in the New England Journal of Medicine. The letter to U.S. Stem Cell Clinic said that the company was offering unapproved stem cell treatments and that an agency inspection uncovered violations of manufacturing standards, including potential sterility issues. The company also tried to stop FDA inspectors from talking with employees, the letter says.\u003c/p>\n\u003cp>“You should take prompt action to correct these deviations,” says the letter, which was sent Thursday. “Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure and/or injunction.”\u003c/p>\n\u003cp>StemImmune did not respond immediately to a request for comment. In a statement, U.S. Stem Cell Clinic said it had given the FDA “unrestricted access” since 2014 and that it followed the agency’s rules. But it also suggested that regulations could prevent patients from getting treatments.\u003c/p>\n\u003cp>“The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the [FDA],” it said, adding: “We have helped thousands of patients harness their own healing potential. It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards.”\u003c/p>\n\u003cp>The actions announced Monday are the latest salvo in a back-and-forth between regulators and the clinics that claim to be able to treat everything from paralysis to neurodegenerative diseases to erectile dysfunction. The clinics, \u003ca href=\"https://www.statnews.com/2016/06/30/stem-cell-clinics-proliferate/\">which have proliferated\u003c/a> around the country in recent years, have largely evaded regulation enforcement because they typically take a person’s own stem cells and inject them back into the same person, meaning the cells are considered “minimally manipulated.”\u003c/p>\n\u003cp>The \u003ca href=\"https://www.statnews.com/2016/02/08/fda-crackdown-stem-cell-clinics/\">FDA has tried\u003c/a> at various times to regulate clinics offering unproven stem cell treatments more tightly and close down clinics that put patients at risk, but overall, their efforts have not amounted to much.\u003c/p>\n\u003cp>The \u003ca href=\"https://www.statnews.com/2016/09/09/stem-cell-fda-hearing/\">FDA has held meetings\u003c/a> about possibly regulating the therapies more like drugs, a move that has been backed by many academic stem cell experts who say that stem cell therapies, while holding great potential, are not ready to be used widely or outside regulated clinical trials. But clinic owners warn that the FDA could stamp out progress in the field and keep desperate patients from getting treatments.\u003c/p>\n\u003cp>“The government should not regulate our bodies. … I will always stand up for patient rights,” Kristin Comella, U.S. Stem Cell’s chief scientific officer, said at an FDA hearing months ago. (The FDA’s warning letter this month was addressed to Comella.)\u003c/p>\n\u003cp>Some experts have wondered whether the regulation-averse Trump administration would take further action against stem cell clinics. But in a statement Monday, Gottlieb said the FDA would be bolstering its enforcement as a way of “separating the promise from the unscrupulous hype” and that the agency would roll out a new “comprehensive policy framework” this fall to delineate the rules for stem cell treatments.\u003c/p>\n\u003cp>“There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products,” Gottlieb said. “These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products as a way of deceiving patients and preying on the optimism of patients facing bad illnesses. This put the entire field at risk.”\u003c/p>\n\u003cp>Experts who study stem cell clinics and the regulatory landscape generally praised the FDA’s moves, but said that it was unclear what the enforcement actions and \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573443.htm\" target=\"_blank\" rel=\"noopener noreferrer\">Gottlieb’s statement\u003c/a> meant for the field going forward.\u003c/p>\n\u003cp>“The most important thing is that the FDA is now publicly making a commitment to discipline what has become an out-of-control area of fraudulent medicine,” said R. Alta Charo, a bioethicist at the University of Wisconsin Law School.\u003c/p>\n\u003cp>One part of Gottlieb’s statement that stuck out to Charo, she said, was when he signaled some flexibility in terms of the areas that are subject to FDA regulation, with the commissioner writing that “the FDA must advance an efficient and least burdensome framework” and establish “a regulatory structure that does not become a barrier to beneficial new innovation.”\u003c/p>\n\u003cp>“It’s about a tone being set,” Charo said.\u003c/p>\n\u003cp>Leigh Turner, a University of Minnesota bioethicist, said that from one standpoint, the FDA’s enforcement actions targeted the low-hanging fruit of the bad actors in the industry. Presumably any administration would want to seize unauthorized smallpox vaccine supplies, and the Florida clinic was the subject of lawsuits and media coverage in addition to the high-profile academic paper.\u003c/p>\n\u003cp>“The larger question is going to be, what about the stem cell clinics … that are out there marketing therapies and charging people but don’t have a New England Journal of Medicine piece or lawsuits?” Turner asked. “Is it just going to be that after harm occurs that the FDA is going to do something? Or are we going to see a more systemic approach to this marketplace?”\u003c/p>\n\u003cp>The action against the California clinics was solely based on the vaccine, noted Turner, who \u003ca href=\"http://www.cell.com/cell-stem-cell/abstract/S1934-5909(16)30157-6\" target=\"_blank\" rel=\"noopener noreferrer\">has tracked\u003c/a> the growth of clinics around the country. It did not mention all the other diseases and conditions that the clinics have been marketing their unapproved stem cell therapies for.\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>\u003cem>\u003cspan style=\"font-weight: 400\">This \u003ca href=\"https://www.statnews.com/2017/08/28/smallpox-stem-cell-clinic/\" target=\"_blank\" rel=\"noopener noreferrer\">story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery. \u003c/span>\u003c/em>\u003c/p>\n\n",
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"nprByline": "Andrew Joseph \u003cbr/>\u003ca href=\"https://www.statnews.com/\">STAT\u003c/a>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003cp>Federal authorities raided a California stem cell clinic and seized a smallpox vaccine that is reserved only for the military and high-risk populations, as the Food and Drug Administration expressed “serious concerns” about how the clinic obtained access to the vaccine at all.\u003c/p>\n\u003cp class=\"danger-zone\">The U.S. Marshals Service seized five vials of the smallpox vaccine, which is not commercially available, the FDA \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573427.htm\" target=\"_blank\" rel=\"noopener noreferrer\">announced\u003c/a> Monday. Four of the vials — which each hold 100 vaccine doses — were unused, but a portion of the fifth vial had been used.\u003c/p>\n\u003caside class=\"pullquote alignright\">'I especially won’t allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.'\u003ccite> FDA Commissioner Scott Gottlieb\u003c/cite>\u003c/aside>\n\u003cp>The treatment mixed some of the vaccine with stem cells taken from a patient to create an injectable — and unproven and unregulated — cancer treatment that was targeted directly at the patient’s tumors, the FDA said. The FDA, which learned of the treatment after inspections, said the injection could have caused inflammation and swelling of the heart.\u003c/p>\n\u003cp>The treatment belonged to San Diego-based company StemImmune Inc., and was given at California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills. U.S. marshals seized the product on Friday.\u003c/p>\n\u003cp>“The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work,” FDA Commissioner Scott Gottlieb said in a statement. “I especially won’t allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.”\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>A complaint filed in federal court indicates the vials were shipped from outside California but does not provide more detail on the origin. StemImmune also filed \u003ca href=\"http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=2&p=1&f=G&l=50&d=PG01&S1=Stemimmune.AANM.&OS=AANM/Stemimmune&RS=AANM/Stemimmune\" target=\"_blank\" rel=\"noopener noreferrer\">a patent application\u003c/a> in February describing “the use of smallpox vaccine to induce an effective anti-tumor immune response.”\u003c/p>\n\u003cp>The type of vaccine that was seized \u003ca href=\"https://www.cdc.gov/smallpox/vaccine-basics/index.html\" target=\"_blank\" rel=\"noopener noreferrer\">is made \u003c/a>from a virus similar to smallpox, but it does not contain smallpox virus and cannot give anyone smallpox, according to the Centers for Disease Control and Prevention.\u003c/p>\n\u003cp>Also Monday, the FDA announced it had sent \u003ca href=\"https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm573187.htm\" target=\"_blank\" rel=\"noopener noreferrer\">a warning letter\u003c/a> to a Florida stem cell clinic where a 2015 procedure led three women to go legally blind, according \u003ca href=\"https://www.statnews.com/2017/03/15/stem-cell-patients-blind-macular-degeneration/\">to a March study\u003c/a> in the New England Journal of Medicine. The letter to U.S. Stem Cell Clinic said that the company was offering unapproved stem cell treatments and that an agency inspection uncovered violations of manufacturing standards, including potential sterility issues. The company also tried to stop FDA inspectors from talking with employees, the letter says.\u003c/p>\n\u003cp>“You should take prompt action to correct these deviations,” says the letter, which was sent Thursday. “Failure to promptly correct these deviations may result in regulatory action without further notice. Such actions include seizure and/or injunction.”\u003c/p>\n\u003cp>StemImmune did not respond immediately to a request for comment. In a statement, U.S. Stem Cell Clinic said it had given the FDA “unrestricted access” since 2014 and that it followed the agency’s rules. But it also suggested that regulations could prevent patients from getting treatments.\u003c/p>\n\u003cp>“The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the [FDA],” it said, adding: “We have helped thousands of patients harness their own healing potential. It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards.”\u003c/p>\n\u003cp>The actions announced Monday are the latest salvo in a back-and-forth between regulators and the clinics that claim to be able to treat everything from paralysis to neurodegenerative diseases to erectile dysfunction. The clinics, \u003ca href=\"https://www.statnews.com/2016/06/30/stem-cell-clinics-proliferate/\">which have proliferated\u003c/a> around the country in recent years, have largely evaded regulation enforcement because they typically take a person’s own stem cells and inject them back into the same person, meaning the cells are considered “minimally manipulated.”\u003c/p>\n\u003cp>The \u003ca href=\"https://www.statnews.com/2016/02/08/fda-crackdown-stem-cell-clinics/\">FDA has tried\u003c/a> at various times to regulate clinics offering unproven stem cell treatments more tightly and close down clinics that put patients at risk, but overall, their efforts have not amounted to much.\u003c/p>\n\u003cp>The \u003ca href=\"https://www.statnews.com/2016/09/09/stem-cell-fda-hearing/\">FDA has held meetings\u003c/a> about possibly regulating the therapies more like drugs, a move that has been backed by many academic stem cell experts who say that stem cell therapies, while holding great potential, are not ready to be used widely or outside regulated clinical trials. But clinic owners warn that the FDA could stamp out progress in the field and keep desperate patients from getting treatments.\u003c/p>\n\u003cp>“The government should not regulate our bodies. … I will always stand up for patient rights,” Kristin Comella, U.S. Stem Cell’s chief scientific officer, said at an FDA hearing months ago. (The FDA’s warning letter this month was addressed to Comella.)\u003c/p>\n\u003cp>Some experts have wondered whether the regulation-averse Trump administration would take further action against stem cell clinics. But in a statement Monday, Gottlieb said the FDA would be bolstering its enforcement as a way of “separating the promise from the unscrupulous hype” and that the agency would roll out a new “comprehensive policy framework” this fall to delineate the rules for stem cell treatments.\u003c/p>\n\u003cp>“There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products,” Gottlieb said. “These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products as a way of deceiving patients and preying on the optimism of patients facing bad illnesses. This put the entire field at risk.”\u003c/p>\n\u003cp>Experts who study stem cell clinics and the regulatory landscape generally praised the FDA’s moves, but said that it was unclear what the enforcement actions and \u003ca href=\"https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573443.htm\" target=\"_blank\" rel=\"noopener noreferrer\">Gottlieb’s statement\u003c/a> meant for the field going forward.\u003c/p>\n\u003cp>“The most important thing is that the FDA is now publicly making a commitment to discipline what has become an out-of-control area of fraudulent medicine,” said R. Alta Charo, a bioethicist at the University of Wisconsin Law School.\u003c/p>\n\u003cp>One part of Gottlieb’s statement that stuck out to Charo, she said, was when he signaled some flexibility in terms of the areas that are subject to FDA regulation, with the commissioner writing that “the FDA must advance an efficient and least burdensome framework” and establish “a regulatory structure that does not become a barrier to beneficial new innovation.”\u003c/p>\n\u003cp>“It’s about a tone being set,” Charo said.\u003c/p>\n\u003cp>Leigh Turner, a University of Minnesota bioethicist, said that from one standpoint, the FDA’s enforcement actions targeted the low-hanging fruit of the bad actors in the industry. Presumably any administration would want to seize unauthorized smallpox vaccine supplies, and the Florida clinic was the subject of lawsuits and media coverage in addition to the high-profile academic paper.\u003c/p>\n\u003cp>“The larger question is going to be, what about the stem cell clinics … that are out there marketing therapies and charging people but don’t have a New England Journal of Medicine piece or lawsuits?” Turner asked. “Is it just going to be that after harm occurs that the FDA is going to do something? Or are we going to see a more systemic approach to this marketplace?”\u003c/p>\n\u003cp>The action against the California clinics was solely based on the vaccine, noted Turner, who \u003ca href=\"http://www.cell.com/cell-stem-cell/abstract/S1934-5909(16)30157-6\" target=\"_blank\" rel=\"noopener noreferrer\">has tracked\u003c/a> the growth of clinics around the country. It did not mention all the other diseases and conditions that the clinics have been marketing their unapproved stem cell therapies for.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>",
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"content": "\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\u003cem>\u003cspan style=\"font-weight: 400\">This \u003ca href=\"https://www.statnews.com/2017/08/28/smallpox-stem-cell-clinic/\" target=\"_blank\" rel=\"noopener noreferrer\">story\u003c/a> was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery. \u003c/span>\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>",
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"info": "The MindShift podcast explores the innovations in education that are shaping how kids learn. Hosts Ki Sung and Katrina Schwartz introduce listeners to educators, researchers, parents and students who are developing effective ways to improve how kids learn. We cover topics like how fed-up administrators are developing surprising tactics to deal with classroom disruptions; how listening to podcasts are helping kids develop reading skills; the consequences of overparenting; and why interdisciplinary learning can engage students on all ends of the traditional achievement spectrum. This podcast is part of the MindShift education site, a division of KQED News. KQED is an NPR/PBS member station based in San Francisco. 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>",
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"tagline": "Politics from a personal perspective",
"info": "Political Breakdown is a new series that explores the political intersection of California and the nation. Each week hosts Scott Shafer and Marisa Lagos are joined with a new special guest to unpack politics -- with personality — and offer an insider’s glimpse at how politics happens.",
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"possible": {
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"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.",
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"pri-the-world": {
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"title": "PRI's The World: Latest Edition",
"info": "Each weekday, host Marco Werman and his team of producers bring you the world's most interesting stories in an hour of radio that reminds us just how small our planet really is.",
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},
"radiolab": {
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"title": "Radiolab",
"info": "A two-time Peabody Award-winner, Radiolab is an investigation told through sounds and stories, and centered around one big idea. In the Radiolab world, information sounds like music and science and culture collide. Hosted by Jad Abumrad and Robert Krulwich, the show is designed for listeners who demand skepticism, but appreciate wonder. WNYC Studios is the producer of other leading podcasts including Freakonomics Radio, Death, Sex & Money, On the Media and many more.",
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},
"reveal": {
"id": "reveal",
"title": "Reveal",
"info": "Created by The Center for Investigative Reporting and PRX, Reveal is public radios first one-hour weekly radio show and podcast dedicated to investigative reporting. Credible, fact based and without a partisan agenda, Reveal combines the power and artistry of driveway moment storytelling with data-rich reporting on critically important issues. The result is stories that inform and inspire, arming our listeners with information to right injustices, hold the powerful accountable and improve lives.Reveal is hosted by Al Letson and showcases the award-winning work of CIR and newsrooms large and small across the nation. In a radio and podcast market crowded with choices, Reveal focuses on important and often surprising stories that illuminate the world for our listeners.",
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"officialWebsiteLink": "https://www.revealnews.org/episodes/",
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},
"rightnowish": {
"id": "rightnowish",
"title": "Rightnowish",
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