June 2021

As time runs out, the Obama administration races to reshape health care

first_imgThe administration seems intent on stretching the authority given to this new agency, called the Center for Medicare and Medicaid Innovation, as far as it can in its final days. The agency, for instance, recently proposed a new plan for overhauling Medicare Part B drug payments — and it’s mandatory for many providers.“They are definitely taking a broad interpretation of the authority and using it as a vehicle,” said Caroline Pearson, senior vice president at Avalere Health, an independent consulting firm. “They’re trying to push through as much regulatory reform as they can.”The administration said that 34 initiatives have been announced or are currently being tested at CMMI.Broadly speaking, the agency has stuck to widely supported ideas for improving health care. That means paying doctors as a group to treat a patient instead of for each individual service, which should foster cooperation. And it means encouraging preventive care to forestall more costly problems down the road.“We believe delivery system reform, and the work of the innovation center, is truly bipartisan,” said Dr. Patrick Conway, chief medical officer at the Centers for Medicare and Medicaid Services, who oversees CMMI. “We think it will continue beyond this administration.”But some of its work is highly controversial — and will still be in its infancy when the next administration takes over, putting it at risk of being undone.The second part of the Medicare drug overhaul, which aims to encourage doctors to prescribe less expensive drugs without sacrificing the quality of care, is currently expected to take effect after Jan. 1, 2017.The pharmaceutical industry is lobbying hard against it, and some physician and patient groups have also said they are deeply concerned. Republicans in Congress have already urged the White House to withdraw the proposal altogether. The opponents describe the plan as an overreach of what CMMI was intended to do and warn it could compromise the care that cancer patients receive.“The part that maybe was unforeseen was the size of the demo, the fact that it was mandatory, the length of time that it was in existence, and the lack of detail about pretty significant changes” to drug payments from the insurance program, Lori Reilly, executive vice president of policy and research at PhRMA, told reporters at a recent briefing.There is some disagreement about what would need to be done to undo what the Obama White House is trying to accomplish — Could a President Trump just sign a piece of paper? Or would he need to go through the regulatory process? What about any contracts that have been signed? — but everybody acknowledges that a GOP president and a Republican Congress could find a way to stop the plans that this administration has put into motion.“If the Republicans win and get their acts together, I think Phase 2 never gets implemented,” Pearson said. “It probably doesn’t go anywhere.” President Obama is racing to burnish his health care legacy before he leaves office. Saul Loeb/AFP/Getty Images PoliticsAs time runs out, the Obama administration races to reshape health care The agency has been credited with some staggering improvements in health care quality. A government report last year found thousands of lives and billions of dollars have been saved since 2010 because fewer people are experiencing complications at the hospital, and it pointed to the new payment models as a contributor. Its first-of-its-kind agreement with the state of Maryland to cap health care costs has shown encouraging early returns, according to Health Affairs.Not every test has been a success, though. Initial results of one program targeting primary care didn’t show any savings. “What we’re seeing is delivery service reform is really hard,” Pearson said.“Most of its efforts and investments are going to take a little bit of time to know,” said Cindy Mann, a former top CMS official, said. “There’s no silver bullet in this business.”That only increases the stakes of the presidential election for CMMI and projects like the Medicare drug-payment demonstration. A Trump-led government could of course repeal the entire law and yield the whole experiment moot.Or, in the other direction, the next administration could follow the Obama administration’s lead and take an expansive view of what CMMI is allowed to do. What that would lead to under a Republican administration is anybody’s guess.“We’re watching this administration use CMMI to its maximum potential to achieve its goals, and a new administration could easily do the same,” said Tricia Neuman at the Kaiser Family Foundation. “We don’t know what that means.” Related: WASHINGTON — As the clock ticks toward Jan. 20, 2017, the Obama administration is racing to burnish its health care legacy, introducing major new initiatives that will take full effect just weeks before the president leaves office.The ranks of the uninsured have dropped dramatically since the passage of the Affordable Care Act six years ago. But administration officials are now hustling to use other parts of the law to reshape how health care itself is delivered across the United States.They’re trying to tackle the biggest health care issue of the day — drug prices — and setting ambitious goals for revamping how primary care is provided. They have also undertaken significant new efforts when it comes to paying for surgeries and preventing disease.advertisement Obama’s Medicare drug payment overhaul is unproven. But it’s worth a shot Every administration tries to get as much done as it can before time runs out, but this White House has a tool that none of its predecessors did: an agency created by the Affordable Care Act and given $10 billion over 10 years to test new models for paying for and delivering health care.advertisement By Dylan Scott May 10, 2016 Reprints Newsletters Sign up for Pharmalot Your daily update on the drug industry. Washington has big hopes, but little power, to negotiate drug prices Please enter a valid email address. Related: “What will happen over the next eight months is as much as these projects can be accelerated, they will be,” said Kathleen Sebelius, the former US Health and Human Services secretary. “The time clock is very much in everybody’s mind.” Leave this field empty if you’re human: Those who worked at CMMI over the years say limbo has become a semi-permanent state at the agency after the Supreme Court cases and congressional repeal votes of the last seven years.“We were always in a constant state at CMMI of wondering whether or not we had a future,” said Andy Shin, who helped launch the agency. “The worst thing for us to do is to start something that’s reversed tomorrow.”Conway has overseen much of this work so far, and he talks with great enthusiasm about the center’s efforts.He said he read a book called “The Other Side of Innovation,” which outlines how to turn “big ideas” into tangible results and spoke with venture capitalists about how to encourage a “startup” mentality inside one of the federal government’s biggest bureaucracies. The tools at his disposal were immense.“It always was known within the department how broad that authority is,” Sebelius said. CMMI “is probably the single most potentially impactful element of the ACA.”Conway remembers walking through the halls of HHS in earlier years, where then-CMS administrator Don Berwick would tell him: “You’re doing a great job, Patrick. Just keep going faster and better.”CMMI’s output suggests Conway took that to heart. But the work has always been about negotiating between short-term and long-term goals, a friction all the more relevant as the administration winds down.“We always feel the urgency of the need to move,” he said.But at the same time, “we view this a long-term journey,” he said. “The way we have tried to manage is: One, where do we want to be in several years? We really manage then down to 90-day cycles. What do we have to do in the next 90 days?” Privacy Policy Tags Affordable Care Actdrug pricesMedicarepolicylast_img read more

Fixing electronic health records is good. Adding scribes is even better

first_img Related: Leave this field empty if you’re human: The medical scribe approach is closely in line with the American Medical Association’s Steps Forward Team Documentation, which is all about “allowing doctors to spend more time with patients by sharing responsibilities with staff.” I believe that we are at the beginning of a massive shift that will lead to other professionals doing nearly all medical documentation chores while doctors focus on their patients.EHRs have value for collecting data about patients, providing safety checks, and making it easier for patients to their medical records. But as Jonathan Bush pointed out, the EHRs our country’s medical professionals use every day need to be better designed for easier use. A more important and more immediate fix is for most medical documentation to be done by professionals other than the doctors, so doctors can do what they were trained to do — focus on their patients.Jared Pelo, MD, is an emergency medicine physician and founder of iScribes, a medical scribes business based in Durham, N.C. Electronic health records ‘inflict enormous pain’ on doctors. It’ll take more than stopwatches to learn why The bold admission by athenahealth CEO Jonathan Bush that electronic health records (EHRs) “inflict enormous pain on our nation’s providers and care teams, turning caregivers into box-checkers and inadvertently limiting the private sector from innovating” caught my attention. Those are strong words from the head of a company that makes a widely used EHR.While Bush’s company is trying to design ways to decrease the amount of time that clinicians spend working on the EHR, here’s a more immediate and practical solution: medical scribes. Let these trained professionals interact with the EHR while doctors interact with their patients. First OpinionFixing electronic health records is good. Adding scribes is even better @JaredPelo By Jared Pelo Sept. 27, 2016 Reprints Related: Privacy Policy About the Author Reprints I became so convinced of the value of medical scribes that I started my own company, iScribes. It is one of several companies that train virtual medical scribes and connect them with health care systems.The medical scribe business is generally growing at internet startup speed because these professionals add significant value by letting doctors work with patients instead of the EHR. Across the industry, they document tens of thousands of patient encounters each month, saving doctors thousands of hours of medical documentation time. We’re also giving doctors their lives back. I know this because I often get emails like this one: “No more charts!! I can take my kids to school in the morning because I don’t have to get to the office an hour early to catch up on dictations.”center_img Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. Please enter a valid email address. When it came time to find my first job out of residency, I wanted to work in a clinic that had scribes. So I joined the main hospital of a small health system in central Virginia. Later, I became the medical director for the emergency department in a smaller hospital that didn’t have scribes. For the first time in my medical career, I had to do all of my own documentation.It was incredibly frustrating to sit and type while the waiting room filled with patients who needed my attention. Much of my time was consumed by medical documentation, which kept me from being a doctor for the patients who needed my help. I was the rate-limiting resource, not to mention the most expensive and most highly trained one. It’s like asking an airline pilot to fly the plane and also schedule the flight, assign the seats, and load and unload the bags.advertisement [email protected] I learned during medical school how onerous it is to document every detail of the work I did while seeing patients. Fortunately, I landed an emergency medicine residency at the University of Virginia, where every resident works with a medical scribe. These aren’t passive copyists, as medieval scribes mostly were. Instead, using mobile technology and a HIPAA-secure cloud, 21st century scribes follow their doctors to every encounter and do the clicking, typing, and record keeping while the doctors examine and talk with their patients.advertisement Jared Pelo Tags electronic health recordsmedical scribes Medical scribe Warren Lam (right) works on notes as Dr. Laura Burke (center) and Dr. Daniel Willner discuss a patient case at Beth Israel Deaconess Medical Center. Kayana Szymczak for STAT The pay is low, the typing nonstop, but the medical scribe business is booming last_img read more

Zika-related defects showing up in babies months after birth

first_img Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Elsewhere recent studies, including one published this week, have shown Zika damages the testicles of infected mice, raising questions about whether infection might have an impact on the fertility of men who contract the virus.advertisement Related: WHO declares Zika public health emergency over, though threat remains @HelenBranswell Related: Zika study showing damage to mice testes raises questions about human effects Tags infectious diseasepublic healthZika Virus About the Author Reprints Aedes aegypti mosquitoes, which can transmit Zika, are seen in a mosquito cage at a laboratory in Cucuta, Colombia. Ricardo Mazalan/AP These and other questions need to be answered, the World Health Organization said Tuesday during a news briefing, after a meeting to discuss Zika research priorities with affected countries.Studies underway to chart how long Zika virus is found in body fluids will need to be expanded to look to see if the damage seen in mice is mirrored in men, said Dr. Nathalie Broutet, a reproductive health expert and coordinator of Zika research for WHO.“We are following up for one year. If we can — and I think we should do that — follow up these men for more than two years and maybe 10 years … so that we can really understand better the long-term impact of this infection,” she said.The WHO announced Friday that it no longer deems the Zika outbreak to be a global health emergency.But Dr. Peter Salama, who heads the agency’s emergencies program, said the move doesn’t signal a waning of concern about Zika. Rather, he said, it reflects the fact that the virus and the disturbing birth defects it can trigger represent “a significant and enduring public health challenge.”Many crucial questions remain to be answered, Salama said. Key among the questions: Why has Brazil recorded so many cases of Zika birth defects when other affected countries have reported so few? The WHO reports weekly on Zika microcephaly cases, which now total about 2,300 worldwide. But Brazil accounts for about 92 percent of the cases, and the lion’s share of the cases comes from the northeast of that country. Helen Branswell HealthZika-related defects showing up in babies months after birth By Helen Branswell Nov. 22, 2016 Reprints The Zika outbreak may no longer be a global health emergency, but the need for answers about the virus remains pressing, a range of experts said Tuesday as a new study underscored the risk Zika poses to babies exposed in the womb.The study, from scientists in Brazil and at the Centers for Disease Control and Prevention, assessed the health of 13 babies who were infected before birth.All were born with normal head sizes but in the months after birth, 11 were diagnosed with microcephaly, the stunted brain condition that first brought Zika to international attention.advertisement Other symptoms that signal Zika-related brain birth defects were recorded in the group. For instance, seven had epilepsy and 10 had difficulty swallowing. Scott Weaver, an expert on viruses that are spread by mosquitoes, finds the discrepancy puzzling.“To be honest, I’ve thought a lot about this, I’ve talked to a lot of people about it and I haven’t heard a very satisfying explanation [for it],” said Weaver, director of the Institute for Human Infections and Immunity at the University of Texas Medical Branch in Galveston.Still, he believes it is starting to appear that the rate of Zika-related microcephaly cases outside of Brazil may be lower than what that country has reported.“I’ll be surprised if the incidence in Colombia and Puerto Rico and other places ends up being as high as northeast Brazil,” Weaver said.CDC Director Dr. Tom Frieden, who remains very concerned about Zika, does not share that view.Frieden said he is skeptical about the suggestion that Zika took a higher toll in northeastern Brazil, saying evidence from a number of places — including CDC data that haven’t yet been published — paint a consistent picture. He theorized that Brazil has recorded higher numbers of cases because it has looked harder than other countries and because its outbreak started sooner.“So I think if people are hoping that this will be something idiosyncratic about that part of the world, that’s very unlikely to be the case from our perspective,” Frieden told STAT.Frieden and Weaver agreed, though, on some of the Zika research priorities, including the need for better tests to figure out, after the fact, who has been infected with Zika and whether infection confers immunity.Existing tests cannot distinguish Zika antibodies from those generated after a bout of dengue fever, except soon after infection. So while experts would like to know whether people in Asia and Africa are vulnerable to Zika or already mostly immune, they currently have no way to answer that question.Frieden and Weaver also agreed that people should not misinterpret the meaning of WHO’s decision to end the Zika global health emergency.“I think the risk is there are a lot of people who will just read the headlines and … some of them will mistakenly assume: ‘OK, it’s safe now to travel wherever I want to go, even if I’m pregnant, even if I’m the partner of a pregnant women,’” Weaver said.That is not the message the CDC wants people to hear, said Frieden, who stressed that pregnant women should continue to avoid travel to places where Zika is circulating.And women who contracted Zika during a pregnancy should have their baby’s development monitored, even if he or she appeared healthy and symptom-free at birth. That’s a lesson from the new study, Frieden said.last_img read more

To our readers: STAT at 1

first_imgDon’t MissTo our readers: STAT at 1 About the Author Reprints [email protected] By Rick Berke Dec. 6, 2016 Reprints Co-founder & Executive Editor Most of our site will remain free, as will our newsletters, including the newly launched “Trump in 30 Seconds.”  We’re so gratified that our readership continues to grow quickly, both nationally and around the world.We strive to surprise readers every day with our journalism. Today we’re publishing a captivating nine-minute mini-documentary from a tiny British isle that plays host to the deadliest motorcycle race in the world. Over the history of the race, 252 people have died; this year, we spent time with a corps of medical volunteers trying to prevent more deaths.Be sure to also check out an exclusive story that speaks volumes about the nation’s opioid crisis: the saga of drug traffickers in Lubbock, Texas, who are accused of using their elementary knowledge of chemistry to import vast quantities of synthetic opioids from China.advertisementcenter_img Rick Berke We are proud of these stories, and so many more produced from our headquarters in Boston, the epicenter of biotech and medicine, and from our reporters in Washington, New York, San Francisco, Los Angeles, Cleveland, and, as of next month, Atlanta.We are also grateful to our sister publication, the Boston Globe, for being such a committed partner, and to our owner and publisher, John Henry, who had the vision to create STAT.Feel free to email me if you have thoughts about our redesign or STAT Plus. I’m at [email protected] and would appreciate the feedback.Here’s a look back at some of our most memorable stories: Barely a year after we launched STAT with a pledge to deliver “fast, deep, and tough-minded journalism” about health, medicine, and scientific discovery, our mission could not be more urgent.Today, we are unveiling a top-to-bottom redesign of STAT. Our new look is sleek and nimble, and we think better conveys our blend of energetic news and analysis, deep narratives and investigations, provocative opinion pieces, heartfelt essays about life and death, and eye-catching multimedia.For our most devoted readers, we’re introducing STAT Plus, a premium subscription plan that will offer exclusive reporting about the pharmaceutical and biotech industries and other benefits. I would encourage you to check it out here.advertisement @rickberkelast_img read more

Trump threatens insurer payments — and health care enjoyed by Congress

first_img WASHINGTON — President Trump on Saturday indicated he will make good on a months-old threat to destabilize the health insurance market if Senate Republicans cannot repeal and replace major elements of the Affordable Care Act.If a new HealthCare Bill is not approved quickly, BAILOUTS for Insurance Companies and BAILOUTS for Members of Congress will end very soon!— Donald J. Trump (@realDonaldTrump) July 29, 2017 Lev Facher By Lev Facher July 29, 2017 Reprints Don Emmert/AFP/Getty Images Tags Donald TrumpinsurancepolicypoliticsWhite House What is it? Log In | Learn More About the Author Reprints The first part of the ultimatum likely refers to cost-sharing reduction payments made by the federal government to insurers, which in turn offer plans with discounted deductibles and copays for many low- or middle-income Americans buying plans through ACA marketplaces. GET STARTED Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Politics Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED @levfacher Trump threatens insurer payments — and health care enjoyed by Congress Washington Correspondent Lev Facher covers the politics of health and life sciences. STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. [email protected] What’s included?last_img read more

Electronics ‘like a second skin’ make wearables more practical and MRIs safer for kids

first_img BERKELEY, Calif. — She’s a physicist who trained in the storied lab where Watson and Crick worked out the structure of DNA. In her years in industry, she made sharper displays for e-readers, more efficient solar panels, and sensor tape that soldiers could wear on the battlefield to measure the strength of explosions.Her manufacturing tool of choice: a simple printer.Ana Claudia Arias is an expert in the field of low-cost printable electronics. Now at the University of California, Berkeley, she’s focused on using printers loaded with a variety of high-tech inks to make a new generation of medical devices, from wearables to barely noticeable MRI hardware for kids.advertisement Trending Now: To speed development of their flexible MRI coils, Arias, with Lustig, Corea, and Balthazar Lechene, a French postdoctoral researcher and materials scientist, have spun off a company called InkSpace Imaging. The name refers to ink for printing, of course, but also to k-space — a technical term for an array of numbers that represents spatial frequency in an MRI image.“It’s very geeky,” Arias said. “We get a laugh every time we think of it.”To get the coils to work in a pediatric hospital, however, also required skills Arias’s team didn’t learn in engineering school.They had to find soft, fuzzy fabric for a “blankie” in which to place the coils. The team went to a Joann store and promptly started arguing over which patterns and colors to use and whether they were gender-neutral or comforting enough. They settled on a bright green, fire-resistant fabric with extremely cute dinosaurs saying ‘RAWR.’“We were asking things like, ‘Would 12-year-olds like dinosaurs?’,” recalled Lechene, who helped develop the coils and now keeps bolts of dinosaur cloth in his office. “These are not questions we normally think about.”There was just one last hurdle: Arias had to teach her engineering students how to sew. “Our dream is to have electronics in things like this,” she said, holding out a piece of plastic mesh so soft it felt like cloth.Arias doesn’t wear a Fitbit. Why would she? To her, they’re bulky, unattractive and, most annoyingly, have to be recharged all the time.Instead, in a lab filled with printers that can extrude liquid silver nanoparticles, carbon nanotubes and semiconducting plastics, Arias and her students have created whisper-thin, flexible devices that monitor a variety of body functions.advertisement There’s a pulse oximeter the size of a Band-Aid, which reads blood oxygen levels from anywhere on the body and could easily be added to a wrist-worn fitness tracker. Tests show it functions as well as the more expensive rigid ones used in hospitals, which work only on translucent parts of the body such as fingers or earlobes.To solve the recharging problem, she’s working on flexible energy storage devices; in one bracelet that can be charged by the sun or indoor light, the solar cell is crafted to look like a jewel. Running out of power is merely an inconvenience for a fitness tracker, but it’s a major issue for monitoring devices in medical settings, said Arias, 44, a native Brazilian.While the world of medical wearables may be eager for much of the technology Arias is cooking up, she’s somewhat exasperated with products for the consumer market. In addition to being too large and uncomfortable for her taste, they’re often unreliable. “They don’t have to go through FDA approval,” she said. “With the Fitbit, sometimes you don’t even have a pulse.”Instead, Arias is building devices that, she said, could provide “real, valid medical information caregivers can use.” She’s working on adapting her pulse oximeter into a bandage-like sensor that could monitor how a wound is healing. She’d like to develop sensors that could slip onto the insoles of shoes to warn diabetics of foot ulcers they can’t feel.“What would be best would be electronics that were almost like a second skin,” she said. “No adhesive. No straps. Almost like underwear — you forget that you’re wearing it.”Researcher Balthazar Lechene holds the “blankie” developed at UC Berkeley that contains printed MRI coils. Usha Lee McFarling/STATA sensor you can barely feel is exactly what Miki Lustig was looking for. Lustig, who works two doors away from Arias, is an electrical engineer and expert in MRI signal processing. He’s been working for 15 years on ways to make MRI images crisper and exams shorter.One of the main problems for all patients, but especially for children, Lustig said, is that traditional MRI coils, which serve as antennae to receive signals from a patient’s body, are rigid, big and bulky. They’re uncomfortable and often lie too far away from the anatomy that requires imaging, resulting in poor image quality. Some coils are so heavy they can crush a small child’s chest and need to be propped up with blankets, pushing them even farther away. @ushamcfarling Leave this field empty if you’re human: Lustig had been pondering the coil problem when he attended a research talk by Arias, who had joined the Berkeley faculty just weeks before. As she described her flexible electronics, he immediately saw the potential and rushed over as soon as her talk ended.“He said, ‘Ana! Do you think you can print coils?’” Arias recalled. “I said, ‘Miki! What are coils?’”But once she learned about MRI coils — and saw the huge need for better ones in pediatrics — she was hooked. “Immediately we started getting materials and trying to test them,” Lustig said.It was a funny collaboration: Lustig, a software whiz, had never built hardware. Arias could build most anything but didn’t know the first thing about MRI. Neither knew anything about radio frequency, a critical component of MRI coils. They forged ahead anyway. “It was a learning curve,” Lustig said. Getting to where they are today — testing lightweight, plastic coils on patients at Stanford’s Lucile Packard Children’s Hospital — took six years.At the hospital, they worked with Dr. Shreyas Vasanawala, a Stanford pediatric radiologist and engineer. He had grown increasingly frustrated with the barriers that prevented many of his young patients from receiving MRIs.When children did get these scans, they often had to be anesthetized to ensure they stayed still during the long exams. And sometimes a tube had to be inserted down their windpipe to ensure they could keep breathing under the heavy weight of the coils. “Something that’s otherwise a completely safe, noninvasive imaging test becomes a much bigger deal,” Vasanawala said.Physicians and parents often opt for simpler CT scans instead. But those scans involve radiation and also don’t image soft tissue nearly as well as MRIs. “Pediatricians have to accept a sub-optimal test,” he said. By Usha Lee McFarling Nov. 15, 2017 Reprints Watch: Episode 11: Building tomorrow’s MRI — faster, smaller, and cheaper HealthElectronics ‘like a second skin’ make wearables more practical and MRIs safer for kids Privacy Policy Related: Usha Lee McFarling Arias’s coils, in contrast, are thin, flat plastic pieces with the receiver material — silver nanoparticles — screen-printed on them. “Just like T-shirts,” Arias said. The coils are light, flexible, and see-through, like a thick report cover.When Joseph Corea, the graduate student who constructed the first coils, showed them to Vasanawala, he was worried they might send out a corrupted signal when they were flexed around a body part. But there were no problems of that sort, Vasanawala said, and a host of benefits. They don’t press down on children’s lungs, for one thing.“They’re so flexible and so low-profile, people don’t notice they’re there,” he said. “MRI techs and nurses tend to focus on the patient instead of the technology.”The crisper medical imaging these coils enable can have a huge clinical impact. Vasanawala described one dramatic case — involving a 5-year-old named Finn Green who was set to have a liver transplant due to cancer. But an MRI scan — with no anesthesia — showed only part of Green’s liver was affected, and allowed a surgeon to take out only the cancerous portion of the liver. The child’s liver grew back to normal size in six weeks. He remains healthy and cancer-free.Lighter and flexible coils are the future, said Jason Polzin, who leads MRI technology development for GE Healthcare and is working with Arias and Vasanawala to incorporate their technology into next-generation coils. “We ask ourselves, how did it go this long with the ways coils are now?,” he said. “It seems so obvious in hindsight.” Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson NewslettersSign up for The Readout Your daily guide to what’s happening in biotech. National Science Correspondent Usha covers the toll of Covid-19 as well as people and trends behind biomedical advances in the western U.S. Physicist Ana Claudia Arias uses printers to create light, wearable electronics for medical monitoring and imaging. UC Berkeley “What would be best would be electronics that were almost like a second skin.” MRI imaging for children is such a problem, the National Institutes of Health has made funding research in the area — including Vasanawala’s and Arias’s work — a priority.“We know MRI can do many wonderful things for adults, but children have been left behind,” said Guoying Liu, who directs the MRI program at the National Institute of Biomedical Imaging and Bioengineering and has funded more than a dozen projects that focus on younger patients. “When I first arrived here eight years ago, there was zero technology development for children. There was nothing. I was shocked.”Dr. Shreyas Vasanawala, a pediatric radiologist at Stanford’s Lucile Packard Children’s Hospital who has been working to make MRIs faster and safer for children. Toni Bird/Lucile Packard Foundation for Children’s HealthMany credit Vasanawala for being the driving force behind improvements to pediatric MRI. He’s spent the last decade working with Lustig and others to find ways to shorten exam times and reduce the need for children to be anesthetized. His team has created software that speeds image gathering and corrects for motion so kids don’t have to keep perfectly still. An MRI can now be done in as little as five or 10 minutes — down from more than an hour — Vasanawala said.His team also created kid-sized flexible coils that are light but denser so more information can be collected for images in a shorter time. These coils are now being developed commercially by GE Healthcare, but are still a bit bulky and definitely noticeable to a child. Please enter a valid email address. About the Author Reprints Ana Claudia Arias, UC Berkeley Related: [email protected] Liquid biopsy could lead to precision therapies for children’s eye tumors Tags medical devicesmedical technologypediatricslast_img read more

World leaders have the power to end TB. They must seize the moment

first_img Tags global healthinfectious diseaseVaccines Please enter a valid email address. Patients infected with multidrug-resistant tuberculosis wait to be seen at the Doctors Without Borders HIV-AIDS clinic in Yangon, Myanmar. Globally in 2016, an estimated 600,000 people developed MDR-TB. Paula Bronstein/Getty Images Attention from global leaders to ending tuberculosis, the world’s deadliest infectious disease, is growing. And that’s very good news. As we mark World TB Day and eagerly await a U.N. meeting on TB in September, we must work to sustain this commitment and build upon it to truly achieve a TB-free world.This is doable, but by no means easy. TB claims 1.7 million lives a year despite being curable for the vast majority of people who contract it. The disease is most concentrated in low- and middle-income countries where only 60 percent of all new cases are being identified each year.According to the World Health Organization, approximately one-third of the world’s population carries the TB bacteria, with about 10.4 million of whom develop “active” TB each year. The disease primarily affects adults during their most productive years, greatly affecting the livelihood of families while also threatening already vulnerable economies in developing nations.advertisement It’s a tragedy that only around two-thirds of the nearly 10.4 million people worldwide living with TB are identified. Not only do some 3.8 million people potentially face a preventable death, TB is transmitted repeatedly in the same places. This vicious cycle continues each year with more people unnecessarily contracting TB, fewer people actually knowing they have it, and nearly 2 million dying of the disease. Leave this field empty if you’re human: Last November, a momentous meeting was held in Moscow focusing on TB. At that gathering, Russian President Vladimir Putin declared that more resources were needed in the fight against TB and said, “I am convinced that only together by closing the ranks will we be able to counter the threat which has acquired truly global character. TB still poses a serious health risk for people all over the globe.”Putin’s words were timely given this September’s first U.N. high-level meeting on TB, which could very well be a turning point in fighting the disease. When the world leaders gather, we hope they commit to the resources necessary to make detection, treatment, and prevention available to all.We remember the U.N. General Assembly special session on HIV/AIDS in 2001 — a meeting that transformed the global response to the disease and saved and continues to save millions of lives. We can do the same with TB in September. We must not miss this historic opportunity. Let’s seize the moment and end TB once and for all.Eric Goosby, M.D., is the United Nations secretary-general’s special envoy on TB. Michel Kazatchkine, M.D., is the special adviser to the Joint United Nations Program on HIV/AIDS (UNAIDS) for Eastern Europe and Central Asia. Genetic tweaks to tuberculosis could speed up discovery of a new vaccine Related: By Eric Goosby and Michel Kazatchkine March 27, 2018 Reprints Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. About the Authors Reprints Ending TB requires political will. Specifically, the global community must unite around efforts to develop better tools to diagnose TB and get to the “forgotten” 4 million who have not been detected; build upon what we know works to prevent, detect, and treat TB; and enact universal health coverage that will help reduce the number of deaths due to TB and other infectious and noncommunicable diseases.advertisement Michel Kazatchkine First OpinionWorld leaders have the power to end TB. They must seize the moment Eric Goosby @UNEnvoyonTB Ending TB also means addressing the growing threat of multidrug-resistant TB (MDR-TB). Globally in 2016, an estimated 600,000 people developed MDR-TB. While the most common form of TB infection continues to decline in the Eastern Europe and Central Asia (EECA) region, MDR-TB infection is dramatically increasing. Today, EECA countries account for 3 percent of the global TB burden, but bear 20 percent of the global MDR-TB burden. Russia is one of the top 20 countries being impacted by MDR-TB.MDR-TB is much harder to treat than common TB and presently requires between nine and 24 months of hundreds of pills and painful injections with side effects such as loss of hearing. The current vaccine poorly protects children from pulmonary disease caused by TB bacteria and does not prevent latent TB from becoming an active disease. The need for a shorter treatment regimen, better treatment drugs, and ultimately a therapeutic or preventative vaccine are even more acute.On top of that, the EECA region is also home to one of the fastest rates of increase in HIV/TB co-infection in the world. The number of people dying from HIV/TB co-infection is increasing at the rate of approximately 13 percent annually. In this context, it is more than frightening to consider that 1 in 8 new TB cases in the EECA region is HIV-positive.The time has come for change. @kazatchkine Privacy Policylast_img read more

What will 2019 bring for science and medicine? We asked the experts

first_img New rules could chill Chinese investment in biotech. Here’s what you need to know About the Author Reprints STAT staff It has been a tumultuous year for science and medicine, and also for the business and politics of both. And with CRISPR babies still in the headlines, Donald Trump still in the White House, and the Dow down again, 2019 is shaping up to be just as turbulent. We asked a whole host of experts — scientists, CEOs, policymakers, and professors — to weigh in on what themes they expect to see emerge in the next 12 months.We’re getting closer to a universal flu vaccineI think we’ll see substantial progress in the quest for improved influenza vaccines that get us closer to the goal of a broadly protective, durable “universal vaccine.” We will not have a true universal influenza vaccine by any stretch of the imagination in 2019. However, we will likely see positive results from clinical trials underway, including serological data from Phase 1 studies that will give us a sense of how well vaccines aimed at “broader coverage” will work. We’ll also see strong preclinical data from exciting new vaccine constructs.I suspect 2019 will also be a year in which long-acting anti-HIV agents (injectable antiretroviral agents and monoclonal antibodies) show indications of being protective against the acquisition of an HIV infection.— Dr. Anthony S. Fauci, director, National Institute of Allergy and Infectious Diseasesadvertisement The CRISPR story is just getting started …In 2019, we predict that advances in CRISPR gene editing and phage therapy will coalesce, and we will witness the first genetically modified phage cocktails being used to cure patients with multidrug-resistant bacterial infections. This will attract new players in the biotech and pharma space and will provide new momentum to bring phage therapy into clinical trials in the U.S.Separately, we also predict that cities in the U.S. that are bold enough to embrace supervised injection facilities will witness a decline in overdose deaths.— Steffanie Strathdee, associate dean of global health sciences, University of California, San Diego, and co-director of the Center for Innovative Phage Applications and Therapeuticsadvertisement By STAT staff Dec. 31, 2018 Reprints Related: Related: Related: Keystone/Getty Imagescenter_img The opioid crisis isn’t slowing down, either.The triple-wave crisis, of opioid pill to heroin to fentanyl overdose, continues to grow and change. There is some good news: Deaths from opioid pills have begun to decline. However, deaths due to synthetic opioids (i.e. fentanyls) continue to peak. Follow these trends for 2019: use of and overdose from stimulants, including methamphetamine and cocaine, continues to rise; contamination of stimulants with fentanyls continues to confound; and fentanyls overall continue to plague. Compassion fatigue and polarization confront us at the community level, yet the policy conversation is getting increasingly creative with harm-reduction notions including drug checking, supervised consumption, and cannabis substitution.— Dr. Dan Ciccarone, professor of family and community medicine, UCSFSpeaking of cannabis (and psychedelics) … it’s only heating up.Changes in federal laws regarding medical cannabinoids will substantially expand scientific research in 2019 in that arena. Scientific evidence is essential to guide the growing use of “medical marijuana” products, which are expected to increase and become even more mainstream in 2019 (as more companies will get into the cannabis market targeting consumer goods and health care). There will, however, be more demands by the public to have better guidance about how to use such cannabis compounds to alleviate their particular symptoms/disease. Physicians will also demand more knowledge in order to guide and treat their patients. As such, there will be more pressure for preclinical and clinical research that has unfortunately lagged behind the growing medical marijuana craze.— Yasmin Hurd, neuroscientist and the director of the Addiction Institute at Mount SinaiIn 2019, more scientific research will be happening into the therapeutic uses of psychedelic compounds than at any time in history. My organization, MAPS, the Multidisciplinary Association for Psychedelic Studies, will be in the midst of our much-anticipated phase 3 clinical trials of MDMA-assisted psychotherapy for the treatment of post-traumatic stress disorder (PTSD), with an eye toward FDA approval in 2021. Early in the year, we’ll finally have the results from our now-completed phase 2 clinical trial of marijuana for symptoms of PTSD in U.S. veterans, the first study of whole plant marijuana for PTSD. The new year will also see the expansion of our MDMA-assisted psychotherapy for PTSD drug development program to Europe, with our European phase 3 trials starting late next year. We can also expect — though it’ll take lots more work! — the continuing destigmatization of psychedelic research worldwide, including (hopefully) more funding support for nonprofit psychedelic research from individuals and institutions across the political spectrum. Our work is cut out for us, but psychedelic science is here to stay.— Dr. Rick Doblin, founder and executive director, MAPSCancer research will increasingly focus on organoids.During the past year, tumor organoids have continued their rise into the spotlight, with new validated cancer models, and more and more data supporting their capability to mimic a patient’s tumor characteristics, as well as drug responses, and methodologies to rapidly screen drugs.The new year will see tumor organoids starting to approach the clinical arena as avatars for identification of effective, personalized therapies, as well as tools to facilitate patient selection for specific trials, with efforts by institutions and scientific societies to streamline standard procedures, define regulatory mechanisms, and support clinical implementation.We are also likely to see a significant increase in the development of models that include a tumor organoid together with an immune system component. These dual models are not only invaluable tools to study the interaction of tumors with immune cells in humans but are also likely to have a transformative impact on the development and testing of immuno-oncology drugs.— Alice Soragni, assistant adjunct professor of hematology-oncology, UCLAYou’ll get more control of your health data.I believe in 2019 we will see a dramatic increase in people acquiring their health data. There have been some exciting technological changes that enable easier access to information such as medical records, lab values, and pharmacy data. With that data in hand, I believe consumers will be better empowered to make decisions about their health and increase their ability to stay healthy!— Anne Wojcicki, CEO, 23andMe With cash and a call for new ideas, Bill Gates tries to boost the campaign for a universal flu vaccine [email protected] Broadly, though, expect a reckoning in the AI space.Health care’s digital transformation will gain momentum in 2019, but health systems will be reluctant to look beyond their electronic health record vendors to try new AI software and other products. There is a lot of hype around AI. The vendors are going crazy. People don’t even know what AI means anymore. Depending on who you ask, you get a different definition. Lots of people in health care are confused by the buzz. They understand that AI is an important part of the future. But what is not clear is what kind of technologies they should be investing in and how reliable the returns will be. So I think you’ll see health care executives become more discerning about what they can use these tools to accomplish.— Paddy Padmanabhan, chief executive, Damo ConsultingNone of this will keep prices down.In 2019, health care costs are going to continue to rise, especially among the employer-sponsored population where employers continue to lack sufficient negotiating power against the rapidly consolidating provider industry and predatory pharmaceutical industry pricing. I’m also predicting that in 2019, increased price transparency, while a worthy endeavor, will not be the panacea that many people expect it to be in terms of lowering health care spending.— Niall Brennan, president and CEO, Health Care Cost InstituteWe’ll get a clearer picture on antibiotic resistance threats.The Centers for Disease Control and Prevention is poised to release an updated “Antibiotic Resistance Threats in the United States” report in the fall of 2019. The original report, published in 2013, sparked action to address antibiotic overuse in human health care and agriculture. Its conservative estimates showed that at least 2 million Americans get sick from antibiotic-resistant infections, and 23,000 die every year. The updated report will likely have a clearer picture of how many people are affected by antibiotic-resistant infections in the U.S., which will fuel efforts to reduce antibiotic use.— Matthew Wellington, antibiotics program director, U.S. PIRG and U.S. PIRG Education FundPharmacies may have to change to stay relevant.From a pharmacy perspective, I think we are going to see a shift in mindset in terms of how we view the traditional role of the pharmacist. The standard definition of a drug is something that treats an illness or a disease. However, we’re seeing now that digital therapeutics and apps can have similar benefits as traditional medications and improve clinical outcomes when used in conjunction with standard therapies. Thus, I predict we’ll see more front-line pharmacists becoming involved with data science and remote patient monitoring programs, which will enable the pharmacist to synthesize data gleaned from pharmacogenomic testing, wearable or digestible sensors, and connected health devices like blood pressure cuffs. All of these findings taken in concert will provide the pharmacist with a holistic view of the patient and ultimately help the community pharmacist better manage patients suffering from chronic diseases.— David Berkowitz, assistant director of clinical pharmacy, Newton-Wellesley Hospital Tags antibioticsbiotechnologyBostoncancerdrug developmentdrug pricinginfectious diseasemedical technologyopioidspatientspublic healthresearchVaccines How 23andMe thinks about genetic privacy in the age of forensic genealogy and Facebook’s woes And so is the focus on China.The biopharma industry relies heavily on outside investment to fuel its research and development. Foreign investment, especially from China, is now making up a larger chunk of those dollars. In 2019, we’re going to see increased interest in our sector from Chinese investors. But new regulations and greater federal scrutiny of foreign investments, like the CFIUS regulation, may hamper or even stop the flow of this capital if they are not executed thoughtfully. As the CFUIS pilot program creates greater uncertainty for both investors and early-stage biotechs that rely on these funds, we may see some investments go to other industries or other countries.– Robert K. Coughlin, CEO, MassBio In the LabWhat will 2019 bring for science and medicine? We asked the experts last_img read more

Biotech’s brash entrepreneur finally finds drug-development success with overactive bladders

first_imgBiotech By Adam Feuerstein March 19, 2019 Reprints What is it? GET STARTED Lisa Lake/Getty Images Senior Writer, Biotech Adam is STAT’s national biotech columnist, reporting on the intersection of biotech and Wall Street. He’s also a co-host of “The Readout LOUD” podcast. Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Vivek Ramaswamy, the hedge fund manager turned biotech entrepreneur, has raised billions of dollars to create a constellation of “Vant” companies that license and develop drugs from other firms. Five years and one spectacular Alzheimer’s drug blowup later, Ramaswamy finally notched a late-stage clinical trial win. It comes courtesy of Urovant, the urology-focused spinout from his Roivant Sciences mothership. On Tuesday, Urovant said its lead pipeline drug, vibregon, achieved all the treatment goals in a Phase 3 clinical trial involving patients with overactive bladder. What’s included?center_img Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED About the Author Reprints Adam Feuerstein [email protected] Log In | Learn More Biotech’s brash entrepreneur finally finds drug-development success with overactive bladders @adamfeuerstein Tags biotechnologydrug developmentlast_img read more

Personalized treatments may be threatened by drug cost-containment proposals

first_img President Trump has said he plans to issue an executive order to lower what the United States government would pay for drugs to no more than “whatever the lowest nation’s price is.” The proposal is designed to end what he has called “global freeloading,” whereby Americans pay more for drugs than residents of other countries.The executive order announcement follows an earlier proposal by the Trump administration to decrease the price of physician-administered therapies by tying them to an international price index so their prices will not exceed those charged in other countries.These proposals, like others that would cut the costs of drugs, are clearly popular. But if implemented they could have disastrous unintended consequences for existing or future high-value personalized cell-based therapies, gene therapies, and targeted medicines that are reshaping the discovery, development, and delivery of health care.advertisement By Edward Abrahams July 18, 2019 Reprints Adobe Backdoor price controls, like those proposed or suggested by the administration, will likely discourage the pharmaceutical industry from making investments in personalized and targeted therapies that address the root causes of diseases rather than merely treating their symptoms. They would also slow the discovery of treatments for diseases that affect small numbers of patients for whom there are no effective medicines by making it even more difficult for pharmaceutical companies to get returns on their ongoing investments in therapies aimed at subpopulations of patients. Some of these medicines have unprecedented upfront costs to develop and deliver, but they represent breakthroughs that can spare patients from a lifetime of ongoing symptoms and costly hospitalizations. According to one recent study, the pharmaceutical industry is developing nearly 300 treatments that, like Zolgensma, prompt a patient’s own cells to address the biological causes of a disease, facilitating a long-term treatment response. The industry is also committed to developing targeted therapies that can be taken regularly to counteract the effects of genetic mutations for certain cancer patients and those with rare diseases.Recent developments in Europe demonstrate that these investments will be at risk if health care decision-makers do not put individual patients at the center of their considerations or if they abdicate their responsibility to make decisions based on what is best for Americans and allow other nations to set the price of drugs.In 2015, for example, the FDA approved Orkambi (lumacaftor/ivacaftor), a drug made by Vertex Pharmaceuticals for treating cystic fibrosis in patients 12 years and older with two copies of a specific gene mutation. Three years later, this lifesaving drug was approved for treating younger children as well. The United Kingdom’s National Institute of Health and Care Excellence (NICE), whose mission is to get the best bargain even if it means denying British citizens access to innovative medicines it deems as overpriced, has embroiled the country in a bitter dispute over the cost of Orkambi.By applying a methodology for assessing the value of drugs that was developed in the days of population-based medicine rather than those of precision medicine, NICE determined that this targeted treatment is not worth what Vertex wants to charge for it. That judgment, if replicated, will likely deter future investment in innovative medicines that require enormous capital, long lead times, and a willingness to tolerate failure rates of 90% or more. Edward Abrahams Even worse, in addition to the detrimental effects of these proposals on the development of innovative therapies, they would lock patients and health systems into a future in which physicians rely on imprecise, one-size-fits-all daily maintenance medications that fail to help many patients at a time when science is beginning to help us better appreciate human heterogeneity and new technologies, such as next-generation sequencing, are ushering us into a new era that promises better outcomes for patients and increased efficiencies for the health system generally.The Trump administration’s cost-cutting proposals, which fail to consider drug prices in the context of overall health care costs, arrive as the global pharmaceutical industry is deeply invested in creating innovative therapies that carry higher price tags, at least in part because the companies that make them must recoup research and development costs from fewer prescriptions administered to smaller patient populations. These smaller populations are defined by specific biological characteristics known to drive disease or predict responses to therapy. The pharmaceutical industry’s attention to these molecular markers lets physicians target more effective treatments to patients who are almost certain to benefit from them, improving patient care and making the health system more efficient.Recent developments in the U.S. Congress are no less concerning than the Trump administration’s proposed price controls. Also aimed at decreasing drug costs across the board without reference to their value to patients and the health care system, some of these ideas, such as House Speaker Nancy Pelosi’s latest drug pricing plan to arbitrate the list prices of 250 drugs, display no discernible concern for the future.Personalized medicine points to a new future for health care that moves away from treatment protocols based on what has been proven to work for the highest percentage of patients with a given disease in favor of analyzing each individual’s specific biological characteristics. In so doing, this precision approach is designed to increase the value of every dollar spent on health care by making upfront investments to understand everything that can be learned about each patient before prescribing a therapy that can deliver the longest-lasting effect.Instead of blindly reducing list prices for all drugs, we should instead seek solutions that assess every treatment in the context of its value to individual patients and the downstream savings they may facilitate elsewhere.Edward Abrahams is the president of the Personalized Medicine Coalition, a nonprofit education and advocacy organization in Washington. Consider Zolgensma (onasemnogene abeparvovec-xioi), which was approved by the FDA in May 2019 as a single-dose, curative treatment for spinal muscular atrophy (SMA), a rare and debilitating neuromuscular disorder that affects fewer than 25,000 people in the United States. Novartis, the company that developed the drug, defends Zolgensma’s $2.125 million price by noting that patients living with SMA regularly generate costs of more than $5 million over 10 years — while still suffering from this horrible disease.advertisement About the Author Reprints Related: I have spinal muscular atrophy. Critics of the $2 million new gene therapy are missing the point Tracking Washington’s moves on drug pricing [email protected] Related: @permedcoalition First OpinionPersonalized treatments may be threatened by drug cost-containment proposals Tags drug pricingprecision medicinelast_img read more