Poison control centers are getting a surge of calls about ‘natural’ painkiller kratom

first_img Synthetic marijuana drives a growing number of overdoses nationwide [email protected] About the Author Reprints Related: General Assignment Reporter Eric focuses on narrative features, exploring the startling ways that science and medicine affect people’s lives. The Drug Enforcement Administration has classified kratom as a drug of concern, but that does not prevent its sale or use. And the FDA has little power to regulate any supplement, including kratom, unless it starts causing widespread harm.“Companies don’t have to prove that something is safe, the FDA has to prove that something is unsafe. But the FDA doesn’t do that,” said Dr. Edward Boyer, a toxicology specialist at Boston Children’s Hospital and UMass Memorial Health Center.He and other specialists worry that what is being sold as kratom could also contain other potentially harmful substances. In fact, they say consumers run that risk with all dietary supplements, given how lightly the FDA regulates the industry.“If you think you’re getting echinacea, you better guess again,” Boyer said. “It could be echinacea or it could be grass from the side of the highway. There’s nothing that prevents them from doing that.” In many cases called into the poison control centers, the side effects of kratom were relatively mild: nausea, vomiting, drowsiness, and agitation. But there was one death, of a patient who took other drugs along with kratom. Other patients who took multiple substances suffered serious side effects — like the middle-aged Massachusetts man whose story was reported as a case study in the journal Addiction. Tags CDCkratomopioidssubstance abuse The number of calls to poison centers about problems stemming from kratom ingestion have increased tenfold over five years. Joe Raedle/Getty Images Kratom comes from the glossy leaves of a tree grown in the jungles of Southeast Asia. Traditionally, in countries like Thailand, the leaves have been crushed or brewed into tea and used as a painkiller or a replacement for opioids. That’s because a few of the chemicals in the leaf stimulate the same brain receptors as drugs like oxycodone and morphine.advertisementcenter_img Popular weight loss supplements contain controversial stimulant, FDA warns @ericboodman The herbal supplement seemed like a miracle. Trying to kick an opioid addiction, the middle-aged man found he could soothe his cravings with a tea made from an Asian plant called kratom. It relieved his pain and made him more alert.But when he combined it with a stimulant, it also gave him a seizure that landed him in a Boston-area emergency room.Those kinds of stories are on the rise, according to a study published Thursday in a weekly report from the Centers for Disease Control and Prevention. The number of calls to poison centers about problems stemming from kratom ingestion have increased tenfold over five years, from 26 in 2010 to 263 in 2015.advertisement By Eric Boodman July 28, 2016 Reprints Related: Kratom is marketed as a natural herbal supplement, but it can be highly addictive. And clinicians and researchers worry about opioid users who try to wean themselves off drugs using kratom rather than seeking professional help.“They want to turn their lives around, they want to get back on track, they turn to kratom,” said Oliver Grundmann, a pharmacologist at the University of Florida who was not involved in the report on poison control calls. “They take more and more and more, but it doesn’t do the job, and then they turn to heroin.”Little is known about the exact workings of kratom on the brain, but it seems to function as a stimulant at low doses and a depressant at high doses, said Royal Law, an epidemiologist at the CDC and a coauthor of the study in the Morbidity and Mortality Weekly Report.The new tally of poison center calls comes as kratom has emerged as a significant public health concern.Six states have banned kratom, and others are considering restrictions, according to the website of the American Kratom Association. The Food and Drug Administration has banned its importation. But it is still widely available online, in tea or capsule form. Some researchers have even found packets of it sold in gas stations. Eric Boodman HealthPoison control centers are getting a surge of calls about ‘natural’ painkiller kratom last_img read more

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Trump picks a longtime hospital administrator to head the VA

first_img @meggophone What is it? What’s included? 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. GET STARTED Politics Dr. David Shulkin has been tapped as the next secretary of Veterans Affairs. Dominick Reuter/AFP/Getty Images [email protected] Trump picks a longtime hospital administrator to head the VA Longtime hospital administrator Dr. David Shulkin, the current undersecretary of health for the Department of Veterans Affairs, has been tapped for secretary of the department, President-elect Donald Trump announced on Wednesday.Shulkin has a background in executive hospital leadership, at many hospitals across the country. He received his medical degree from the Medical College of Pennsylvania in 1986.center_img 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. Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+. First 30 days free. GET STARTED About the Authors Reprints Megan Thielking By Ike Swetlitz and Megan Thielking Jan. 11, 2017 Reprints News Editor Log In | Learn More Tags policyveteransWhite Houselast_img read more

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Training medical students how to teach helps them embrace ambiguity

first_img Medical students need to be quizzed, but ‘pimping’ isn’t effective @jasmine_rana17 In volunteering to help teach the course, neither of us anticipated that questions asked by first-year medical students would heighten our curiosity and passion for medicine. But they did. We looked for answers and followed up with the students who asked them. In the process, we also reflected on how to be better self-directed learners and more effective teachers.When it comes to teaching, medicine is unique. In music and sports, for example, teachers and coaches tend to be experts, like a concert pianist or former professional soccer player. In medicine, it’s junior doctors who do a fair amount of the teaching. In one study about the transmission of medical knowledge, medical students estimated that one-third of their clinical education on hospital wards came from resident physicians — doctors in training only a few years out of medical school.Even though teaching is a core skill for physicians, little emphasis has been placed on training residents how to teach. The Accreditation Council of Graduate Medical Education, the organization responsible for accrediting most of the graduate medical training programs for physicians in the US, has mandated that residency programs spend time training their residents how to teach. Many residencies even have dedicated resident-as-teacher programs. In reality, though, it is a challenge to prioritize such programs while residents are working 80 hours a week learning to care for patients.That, in part, has been an impetus for the rise of student-as-teacher programs. As the name implies, these are designed to help medical students learn teaching skills. If they can begin their post-med school residencies with effective teaching strategies, they will be better prepared to transmit knowledge and teach the medical students they encounter and, in turn, be able to focus more of their time developing patient care skills.Our experience teaching first-year medical students brought home another important benefit of student-as-teacher programs: They help students learn how to grapple with uncertainty and ambiguity.In medical education, there is traditionally little or no focus on helping trainees build comfort within the “gray space” of practicing medicine. As one of our favorite teachers, Dr. Richard Schwartzstein, likes to say about patients who do not have classical symptoms of an illness, “Patients don’t always read the textbook.” Yet textbooks are the primary learning resource that we use as medical students, which may constrain our ability to acknowledge the full spectrum and variation of disease. Moreover, senior physicians often “pimp” students with obscure black-and-white factual questions. Many rightly argue that this old-school practice needs to change because uncertainty and ambiguity are intrinsic to the practice of medicine — and our ways of teaching and learning should reflect that. In our experience as student teachers, we found ourselves embracing ambiguity instead of shying away from it. Explaining nuanced clinical topics to junior learners made us more aware of the limitations of our knowledge and our initial knee-jerk desire to provide black-and-white answers, like those found on board exams. Being able to reflect on our understanding of the topics we have taught has also given us more confidence to acknowledge context and complexity in medical care, which are often not captured fully in exams or textbooks.Perhaps most importantly, we are learning to value academic humility, which is arguably a prerequisite for a career path that requires lifelong learning and curiosity. This made us more comfortable answering learners’ questions with, “I don’t know,” followed by, “Let’s look this up together” — a strategy we also plan to use in our interactions with patients.Although more outcomes-based research needs to be done about peer teaching, existing research and anecdotes support many of our positive experiences as student teachers. A recent meta-analysis concluded that learners do just as well whether they are taught by student teachers or faculty members, alleviating a common concern often voiced by faculty members and student learners about “non-expert” student teachers.In addition to having us teach medical students, the elective we took part in included how-to-teach sessions given by local clinician-educators. Such carefully designed student-as-teacher programs can benefit everyone involved.The culture of medicine in which we learn and practice needs to evolve from “see one, do one, teach one” to more thoughtful ways of teaching and learning that embrace multi-dimensional thinking instead of black-and-white answers. Teaching medical students how to teach may be one way to build for them more nuanced, collaborative, and curiosity-driven learning environments. Ultimately, it is patients who will benefit the most from having doctors who are comfortable working with their patients in the increasingly nuanced world of medicine where uncertainty and ambiguity are common.Jasmine Rana and Taylor Freret are MD candidates in Harvard Medical School’s class of 2017. Tags educationphysicians Medical education needs to take ‘an ounce of prevention’ seriously Related: Related: Jasmine Rana By Jasmine Rana and Taylor Freret May 22, 2017 Reprints “That’s a good question.” We looked at each other, wondering if either of us had an answer, and then uttered the sentence that became commonplace during our stint as student teachers: “We don’t know.” [email protected] About the Authors Reprints Taylor Weidman/Getty Images Just months away from our medical school graduation, we found ourselves teaching in the first-year physiology course we had taken what seemed like eons ago.“Should you give fluids to a patient with a myocardial infarction?” a student asked.We had spent the past four years learning from textbooks and doctors and patients. This teaching experience was making us realize how much we had learned and, more important, how much we had yet to learn.advertisement Taylor Freret “It depends,” we began, taking turns explaining how the location of the infarction (more commonly known as a heart attack) and the patient’s signs and symptoms determine whether to give intravenous fluids.“How do you know what pressor to use?” another student asked, referring to the class of medications used to raise blood pressure.advertisement [email protected] First OpinionTraining medical students how to teach helps them embrace ambiguity last_img read more

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How coconut oil got a reputation for being healthy in the first place

first_imgLeave this field empty if you’re human: But, Willett noted, alternatives such as olive oil and soybean oil, which are mainly unsaturated fat, both lower LDL and increase HDL — making them a clearly healthier choice for cholesterol overall.For those wondering what to cook with, St-Onge suggests healthier options supported by the scientific literature.“The state of the science right now supports mono-unsaturated fats and poly-unsaturated fats — vegetable oil, olive oil, corn oil — as being healthy options,” she said. Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Related: So how did that healthy reputation come to be? The answer traces back in part to the work of Marie-Pierre St-Onge, a professor of nutrition at Columbia University. Two papers published by St-Onge’s group in 2003 showed that eating and cooking with medium chain fatty acids — a type of molecule found in coconut oil — can help dieting adults burn fat. Study participants ate specially prepared meals rich in medium chain fatty acids for four weeks. MRI and metabolic data showed that medium chain fatty acids reduced their overall fat levels and helped dieters burn energy. Butter doesn’t increase risk of heart disease after all By Jonathan Wosen June 20, 2017 Reprints Please enter a valid email address. HealthHow coconut oil got a reputation for being healthy in the first place But, St-Onge points out, coconut oil is only 14 percent medium chain fatty acids. Participants in her studies received 100 percent medium chain fatty acids, a custom-made concoction.advertisement Privacy Policy Still, in subsequent years that research has been seized upon by health food marketers. Dieting blogs praise coconut oil as a “fat-burning diet miracle” and dietary supplements containing the oil advertise their supposed weight-loss benefits on the label.“I think the data that we’ve shown with medium chain fatty acids have been extrapolated very liberally,” said St-Onge. “I’ve never done one study on coconut oil.”Cholesterol conflictAnother aura of healthfulness around the oil is in boosting “good” cholesterol. Some studies have found that people who eat more coconut in general have higher healthy HDL cholesterol.“Fat in the diet, whether it’s saturated or unsaturated, tends to nudge HDL levels up, but coconut oil seems to be especially potent at doing so,” Harvard nutrition professor Dr. Walter C. Willett wrote in a blog post on the subject. Janice Newell Bissex & LIz Weiss/Creative Commons The news rocketed around the internet last week under headlines declaring “Coconut oil is not a magical health food after all,” “Coconut oil ‘as unhealthy as beef fat and butter,’” and “Careful: Coconut oil may not be safe.”Behind the furor was an innocuous American Heart Association report reviewing the health harms of saturated fats and urging Americans to eat less of them. But the finding that seemed to come as the biggest surprise to the public was the inclusion of coconut oil on the list of the most egregiously unhealthy fats. Coconut oil has more saturated fat than butter or lard, the report pointed out, and studies have shown it increases unhealthy LDL cholesterol.But those facts have been known for years — and still, a survey conducted last year by the polling firm Morning Consult found, 7 out of every 10 Americans consider coconut oil a healthy food.advertisementlast_img read more

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Maraganore runs away with best biopharma CEO award; Soon-Shiong wins prize for worst

first_img GET STARTED Adam Feuerstein Maraganore runs away with best biopharma CEO award; Soon-Shiong wins prize for worst 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. You, the readers of STAT, have spoken. Your votes determined the best and worst biopharma CEOs of 2017.The Best: John Maraganore of Alnylam Pharmaceuticals. Congratulations, John! Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Log In | Learn More 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. What’s included? About the Author Reprintscenter_img 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. By Adam Feuerstein Dec. 17, 2017 Reprints Adam’s Take @adamfeuerstein What is it? Hyacinth Empinado/STAT [email protected] Tags biotechnologycancerrare diseaselast_img read more

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Pharmalittle: Pharma accounted for a lot of fraud last year; what becomes of Apotex?

first_img Ed Silverman 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. What’s included? Pharmalot Hello, everyone, and nice to see you again after the extended holiday break. We reveled in some rare time with our short people and we hope your own mini-break was relaxing and fun, especially since the oh-so-familiar routine of meetings, deadlines, and what-not is poised to return with a vengeance. You knew this was coming, yes? So what better way to cope than with a fresh cup of stimulation? We are quaffing vanilla cinnamon, for those who track this sort of thing. Meanwhile, we are playing catchup, not surprisingly, and have provided some tidbits that span several days. Hope your day goes well and you ease in gracefully. …Drug and device makers accounted for more than $900 million of $3.7 billion in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending Sept. 30, 2017, according to the feds. Shire (SHPG) paid $350 million to resolve allegations of paying kickbacks and illegally marketing a medicine, while Mylan paid $465 million to resolve allegations that it underpaid rebates owed under the Medicaid Drug Rebate Program for EpiPen. Log In | Learn More 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. Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED [email protected] center_img Alex Hogan/STAT What is it? About the Author Reprints By Ed Silverman Jan. 2, 2018 Reprints Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. @Pharmalot Pharmalittle: Pharma accounted for a lot of fraud last year; what becomes of Apotex? Tags financeMedicaidMedicarepharmaceuticalspharmalittleSTAT+last_img read more

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Philly city council committee eases ordinance to restrict sales reps after lobbying pushback

first_img After lobbying by the pharmaceutical industry, a Philadelphia City Council committee late last week agreed to amend a controversial ordinance that would ban drug makers from giving gifts to doctors and also require all sales reps to become licensed in hopes of blunting the opioid crisis.The key concession by the lawmakers was to offer an exemption for conventions, while yet another exemption would delay enforcement for 180 days after the ordinance becomes law. As it so happens, the BIO trade group has such an event scheduled in Philadelphia in early June. Log In | Learn More By Ed Silverman Dec. 3, 2018 Reprints Ed Silverman Philly city council committee eases ordinance to restrict sales reps after lobbying pushback Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! 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. Tags pharmaceuticalsSTAT+states @Pharmalot 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.center_img GET STARTED [email protected] Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. What is it? BIO’s 2018 convention took place in Boston. David L Ryan/Globe Staff Pharmalot About the Author Reprints What’s included?last_img read more

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Pharmalittle: Roche will pay $4.8 billion for Spark; Senate drug pricing hearing is like deja vu

first_img Pharmalittle: Roche will pay $4.8 billion for Spark; Senate drug pricing hearing is like deja vu @Pharmalot About the Author Reprints Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that familiar routine of meetings, deadlines, and what-not has, predictably, returned. To cope, we are resorting, as always, to cups of stimulation. And all the better to help us tune out a long-running windstorm attacking the Pharmalot campus and nearby environs. The ongoing, 60-mile-per-hour gusts give new meaning to the idea that life is a breeze. Meanwhile, here are some tidbits. Hope your day goes well and do stay in touch.Roche (RHHBY) is buying Spark Therapeutics (ONCE) for $4.8 billion in hopes of expanding its presence in the market for treating hemophilia, The Wall Street Journal reports. Hemophilia is a new and emerging category for Roche; in 2017, the Food and Drug Administration approved a hemophilia A treatment, Hemlibra, which analysts expect will have billions of dollars in yearly sales. Moreover, as STAT notes, the deal underscores the desire among the largest drug makers to sell gene therapies and that such big biopharma deals are back. 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. By Ed Silverman Feb. 25, 2019 Reprints Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Log In | Learn More Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Ed Silvermancenter_img 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. GET STARTED Alex Hogan/STAT [email protected] Tags drug pricingfinancelegalpharmaceuticalspharmalittleSTAT+ What’s included? What is it? Pharmalot last_img read more

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The Ebola response effort is struggling. Experts say these steps could help

first_img Could an emergency declaration over Ebola make a bad situation worse? @HelenBranswell By Helen Branswell May 22, 2019 Reprints With Ebola response teams struggling to contain the outbreak in the Democratic Republic of the Congo, the World Health Organization and its partners can make changes to shore up their effort and try to prevent the crisis from escalating further, according to a handful of experts surveyed by STAT.The experts are wary of criticizing WHO officials and others trying desperately to stop the virus from spreading. Violence aimed at Ebola response workers and a refusal to cooperate with control measures in some communities has rendered this outbreak, the second largest on record, unlike anything the world of Ebola responders has seen before. There have been repeated attacked on Ebola treatment centers, and on many days response workers have been unable to move about in outbreak hotspots.At the same time, the experts believe global health officials have opportunities to bolster their efforts.advertisement If Ebola treatment centers are seen as toxic, find alternativesIn some communities, there remains deep-seated reluctance to go to Ebola treatment centers. Doctors Without Borders, which pioneered the current system of Ebola treatment centers, has suggested diversifying care options might help.ETCs, as they are called, have become a place of stigma, associated with death. In fact, people who seek care in treatment centers quickly after the onset of symptoms have a higher chance of survival than those who eschew the centers — but that reality has not been recognized in the affected communities.Doctors Without Borders has proposed that some hospitals in the outbreak zone be trained to treat Ebola patients safely — without posing a risk to their other patients — because the reality is that many people with Ebola symptoms turn to clinics or hospitals rather than ETCs.Likewise, the group has urged the health ministry to consider allowing for some home care of Ebola patients, even suggesting that experimental Ebola drugs might be administered by a team of visiting health workers to some patients being cared for at home.Ronsse said ETCs should remain the primary sites for care of Ebola patients. But with so many patients refusing to go for to them, finding ways to minimize the risk these patients present to the health workers who care for them in hospitals or family members in households could help reduce transmission. Recently the WHO reported that 68% of the people who have died from Ebola in this outbreak died in the community — at home or in a health facility that was not a treatment center.“It’s something else we could do,” Ronsse explained. “But we cannot do only home-based care or only treatment at the level of the health center. We should have the three levels.”Likewise, Ronsse said home care — which would involve training family members to take precautions and giving them protective equipment and cleaning materials — is not something that could be done on a large scale. “It’s really for the people who would not accept to come to the center,” she said. Rollin, who is following the outbreak closely, is worried about the fact that so few probable cases are being added to the outbreak totals. Probable cases are people who had Ebola-like symptoms and who had contact with people who either were known cases or who also had what looked like Ebola. Often these are people who died and were buried without being tested for the disease, but for whom there is a high likelihood that they were infected.Given how many people are refusing to cooperate with the Ebola response teams — staying home when they are sick, fighting off safe burial teams that try to test corpses — there should be a steady stream of probable cases, Rollin said. And yet they are rare. “So they’re missing a lot of cases,” he said.Lab capacity needs to be increasedThere are serious concerns that the existing laboratory capacity to test samples from suspected Ebola cases can no longer keep pace with the number of tests that need to be conducted.DRC’s National Biomedical Research Institute — INRB — is overseeing the testing. Rollin and others fear the current needs exceed its capacity, leading to delays in getting test results.“The lab is overwhelmed,” Rollin said. HealthThe Ebola response effort is struggling. Experts say these steps could help Related: Related: Tags infectious diseasepublic healthVaccines Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. Please enter a valid email address. Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Helen Branswell Trending Now: Privacy Policy Here are three.Good data are keyThe foundation of any Ebola response is epidemiology. Knowing where the virus is spreading and who is in its path is crucial to bringing an Ebola epidemic under control. But from the earliest days of this outbreak, that’s been a problem.advertisement ‘On a knife edge’: Ebola outbreak threatens to escalate as violence rises About the Author Reprints Health workers carry the coffin containing of an Ebola victim in Butembo, in the Democratic Republic of the Congo. JOHN WESSELS/AFP/Getty Images “I don’t think there is a good record of what’s going on. I don’t think there’s a good database,” said Dr. Pierre Rollin, a veteran Ebola responder who retired earlier this year from the Centers for Disease Control and Prevention. “We’re just driving in the fog because we don’t have good data.”Every single previous Ebola outbreak was stopped using the same techniques: find the cases and isolate them so they cannot infect more people. Figure out with whom they’ve had contact and monitor those people daily. If any of them become ill, isolate them and find their contacts. Bury the dead safely, so that funeral rituals don’t end up infecting more people.In this outbreak, responders have had an additional tool: an experimental vaccine.For this approach to work, though, the surveillance teams need to know in which social networks the Ebola virus is spreading. In this outbreak, that often hasn’t been the case. Significant numbers of the new cases were not previously on contact lists. Their health hadn’t been monitored and they weren’t offered vaccine because no one knew they had been exposed.The impact of these unidentified chains of transmission appears to be growing as the outbreak expands. Since the beginning of May, only one-third of new cases were known contacts of a previous case. Only about half of those had agreed to be monitored to see if they were developing symptoms. Most had not agreed to be vaccinated.Dr. Scott Dowell, deputy director for surveillance and epidemiology at the Bill and Melinda Gates Foundation, shares concerns about the expanding number of unrecognized cases.“I think there is very likely a large pool of unrecognized transmission out there and unidentified patients,” said Dowell, who worked for decades for the CDC and has worked a number of Ebola responses. “And it’s uncertain just how big that pool is. And also uncertain to me about whether the current response can get on top of it, which is really worrisome.” Leave this field empty if you’re human: If a laboratory can’t quickly process all the tests taken, it is effectively capping the number of new positive cases that can be found, said Dowell. It’s not that they aren’t there; it’s that the lab can’t pinpoint them in a timely manner. That leads to slowdowns in identifying the contacts of new cases and inviting them to be vaccinated. People who need vaccine may be vaccinated too late to prevent infection.The delays in getting test results are also discouraging people from coming forward to be tested, said Dr. Axelle Ronsse, an emergency coordinator for the Belgian branch of Doctors Without Borders. Test results can sometimes take two or three days.The Gates Foundation is urging the Congolese Ministry of Health and the WHO to start using rapid point-of-care tests that were developed after the West African Ebola outbreak of 2014-2016, said Dowell, who noted these tests could greatly increase the number of people who are tested.There’s a concern the tests could lead to some false negatives — people who are actually infected, but don’t test positive — Dowell admitted. But finding more infected people more quickly, even if it’s not all of them, should help, he said.The lab capacity issue also extends to the sequencing of Ebola viruses, a technique that can be used to fill in information gaps of chains of transmission when, as with this outbreak, they occur.Newly confirmed cases may not know where or how they became infected. But by comparing the sequence of their virus to the sequences of other cases, it can become clear that the infection occurred when two unrelated people were in a clinic on the same day, or that this patient likely infected that taxi driver.INRB, the Congolese national lab, has been sequencing viruses. But the information it is finding isn’t always being shared in a timely way with the teams doing case surveillance. And capacity is an issue here as well. “As the number of daily positives has grown, the sequencing hasn’t nearly kept pace with those positives,” Dowell said.A report to the World Health Assembly from a group that advises the WHO’s emergencies program hinted at insufficient use of the sequencing data, saying that “timely analysis of genetic sequencing data are critical to fully characterize the evolution of the [Ebola] outbreak in order to inform diagnostic, vaccine and treatment approaches.” It recommended “closer collaboration between INRB and WHO.”last_img read more

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AIDS activists say Gilead put profits over patients — and misled Congress about an HIV pill

first_img AIDS activists say Gilead put profits over patients — and misled Congress about an HIV pill Ed Silverman About the Author Reprints [email protected] Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED GET STARTED Log In | Learn More What is it? 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. Last May, Gilead Sciences (GILD) chief executive Daniel O’Day testified before Congress that a revised version of a best-selling HIV pill was a “brand new medicine” and that the company was “absolutely not” aware it was safer than an older version during the early stages of development.Yet a recently filed lawsuit offers details that purportedly contradict his remarks and, in the process, raises questions about the extent to which Gilead may have deliberately delayed bringing a new treatment to market in order to milk sales of an older, lucrative franchise.center_img @Pharmalot By Ed Silverman Aug. 19, 2019 Reprints Gilead CEO Daniel O’Day Roche Pharmalot What’s included? Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. 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. Tags CongressHIV/AIDSlast_img read more

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