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.
Don’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.advertisement 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 @rickberke
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?
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 Images 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
Biotech 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? 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 development
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 medicine