American Medical Association wants to ban drug ads to consumers

first_img @Pharmalot About the Author Reprints Benjamin Stone/Flickr PharmalotAmerican Medical Association wants to ban drug ads to consumers In fact, the AMA plans to convene a task force and launch an advocacy campaign to promote greater affordability for medicines and greater transparency in prescription drug prices. The AMA worries that patients are foregoing needed treatment due to rising costs and limitations on insurance coverage. Tags advertisingAmerican Medical Associationprescription drugs By Ed Silverman Nov. 17, 2015 Reprints Why doctors’ call to ban drug advertising is a dead end In a dramatic step, the American Medical Association is calling for a ban on advertising prescription drugs and medical devices directly to consumers. The move, however, is largely symbolic, because any ban would have to be authorized by Congress.The new AMA policy comes after years of complaints by physicians. Ever since the Food and Drug Administration revised guidelines in 1997 to permit drug firms and medical device manufacturers to use broadcasting advertising, doctors argued some ads too often encourage patients to seek medicines unnecessarily. They also resent the pressure the ads place on them to write prescriptions out of concern patients will switch physicians.Another rationale for the ban, however, is the rising cost of drugs. Doctors have long argued that many of the ads aimed directly at consumers promote more expensive medicines. This, in turn, raises overall health care costs.advertisement Related: Ed Silverman Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. [email protected] The new policy “reflects concerns among physicians about the negative impact of commercially driven promotions, and the role that marketing costs play in fueling escalating drug prices,” said AMA Board Chair-elect Dr. Patrice Harris, in a statement. “Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate.”advertisement The AMA noted that prices on generic and brand-name drugs rose 4.7 percent this year, according to the Altarum Institute Center for Sustainable Health Spending. And the organization also pointed out that advertising dollars spent by drug makers increased by 30 percent in the last two years to $4.5 billion. The organization cited data from Kantar Media, a market research firm.By casting the issue in the context of rising drug prices, the AMA is clearly trying to create as much support as possible for a ban. The cost of pharmaceuticals, after all, is a hot-button issue that has galvanized much of the American public in recent months. The AMA proposal amounts to yet another indication that drug pricing will remain a policy issue for the near-term.Not surprisingly, industry reaction was scathing.One trade group that represents advertisers and marketers argues that a ban would violate free speech rights. “It flies in the face of the First Amendment,” John Kamp, who heads the Coalition for Healthcare Communication, told us. Companies, he explained, have a right to tell “the truth” about their products.He also maintained that patients and caregivers “want and deserve up-to-date information on the availability of drugs. The days of Dr. Kildare being the exclusive source of information about health and medicine have come and gone.”A spokeswoman for the Pharmaceutical Research and Manufacturers of America, the trade group for drug makers, sent us this: “Providing scientifically accurate information to patients so that they are better informed about their health care and treatment options is the goal of direct-to-consumer pharmaceutical advertising about prescription medicines.“Beyond increasing patient awareness of disease and available treatments, DTC advertising has been found to increase awareness of the benefits and risks of new medicines and encourage appropriate use of medicines. In addition, DTC advertising encourages patients to visit their doctors’ offices for important doctor-patient conversations about health that might otherwise not take place.”last_img read more

Scientists unearth bacteria from stomach of 5,300-year-old iceman

first_imgIn the LabScientists unearth bacteria from stomach of 5,300-year-old iceman Scientists have learned a great deal about Ötzi the iceman, including that he was closely related to people living today in Corsica and Sardinia. EURAC/Marion Lafogler Watch: Peek inside a lab trying to create living medicine — from bugs in your gutPart of the reason Ötzi is so revealing is the way he died. He was probably killed by an arrow to the back. His body was then quickly buried in snow and then freeze-dried. As a result, he wasn’t torn apart by scavengers or decomposed by microbes.When researchers began to study Ötzi, they focused their attention on his anatomy, using X-rays to probe his bones, muscles, and organs. But in recent years they’ve also begun using DNA-sequencing technology to search for genetic material. In 2012, researchers published Ötzi’s entire genome, which showed he was closely related to people living today in Corsica and Sardinia. He had genes for type O blood and brown eyes; he was probably lactose intolerant and ran an increased risk of coronary heart disease.advertisement In 1991, a German couple hiking in the Alps came across the body of a middle-aged man lying face down in a snowfield. It took days for a recovery team to hack him out of the ice and haul him by helicopter and truck to a lab in Austria. There, scientists determined the man had died 5,300 years ago.Ötzi, as the man was nicknamed (after the nearby Ötztal Valley), has kept scientists very busy for the past 24 years. They’ve even built an entire research center — the Institute for Mummies and the Iceman in Bolzano, Italy — to house Ötzi and study him. They’ve slowly extracted one clue after another about how Ötzi died and, more importantly, how he lived.But Ötzi still has much left to tell us. On Thursday, researchers reported in the journal Science that they have reconstructed the entire genome of a species of bacteria that lived in his stomach. Now Ötzi may be able to tell us not just about ancient humans. He can tell us about ancient microbiomes, too.advertisement Related: After its discovery, Frank Maixner, the coordinator at the Institute for Mummmies and the Iceman, and his colleagues decided to search Ötzi’s stomach for one of its best-known residents: a species of bacteria called Helicobacter pylori.Helicobacter pylori causes stomach ulcers and gastric cancer. But that doesn’t mean that H. pylori is nothing more than a microscopic enemy of our species. It only causes ulcers and gastric cancer in a small fraction of its hosts; in the rest, it lives harmlessly. Some research even suggests that in children, H. pylori helps the immune system develop properly, reducing their risk of immune disorders like asthma.Ever since scientists discovered its link to ulcers in the 1980s, they’ve wondered how long H. pylori has been lurking in our ancestors. It might have leaped into our stomachs relatively recently, or it may have been adapting to our bodies for a long time.Eduard Egarter-Vigl, left, and Albert Zink take a sample from the iceman in November. EURAC/Marion LafoglerIn recent years, studies on H. pylori in living people have hinted that it’s an old lodger. The deepest branches of the bacteria’s family tree can be found in Africa, where our species originated 200,000 years ago. As humans expanded to other continents, they took distinctive strains with them.Maixner and his colleagues decided to test that hypothesis by looking in Ötzi for the bacteria. They carefully extracted bits of his stomach to study.“The material was quite crumbly — it was like sand,” said Maixner. But to his delight, it was rich in DNA. Some came from Ötzi himself, and some from the animals and plants in the food he ate before he died. And some, it turned out, came from H. pylori.Whenever scientists find DNA in ancient remains, they have to take extra steps to rule out the possibility that the DNA actually comes from some modern organism that contaminated their equipment.In their new study, Maixner and his colleagues only found H. pylori DNA in the stomach, and not in nearby tissue. The DNA was also damaged in a distinctive way that allowed them only to see DNA that has been lying around for thousands of years.“These two facts led us to the assumption that we were on the right track,” said Maixner.The scientists then pieced together overlapping DNA sequences of Ötzi’s H. pylori. Eventually they could build up almost the entire genome of the microbe. Before the new study, H. pylori expert Martin Blaser, the director of the Human Microbiome Program at New York University Langone Medical Center, had been skeptical that anyone would ever find DNA from ancient H. pylori. “Now we have a solid piece of data,” he said.As old as Ötzi’s bacteria may be, they were already pretty much the same as ones carried by humans today. They had the same genes that lead H. pylori to cause ulcers and gastric cancer. With Ötzi’s stomach turned to sand, Maizner has no way to see if he had those woes. But he certainly was at risk for them.Ötzi was also able to shed some light on how H. pylori came to Europe. In living Europeans, H. pylori is an enigmatic chimera. Some parts of its genome closely resemble the DNA of H. pylori carried by people in northeast Africa. Other parts match H. pylori from south Asia. Scientists have long suspected that two strains of the bacteria from these regions must have come together in a single stomach and swapped DNA. But they couldn’t say when or where that exchange took place.Ötzi, it turns out, had bacteria that were profoundly different from that of living Europeans. “Compared to living Europeans, he has a nearly pure ancestral Asian strain,” said Maixner.Maixner and Blaser both said that this finding could fit a few different scenarios.It’s possible that Europeans started out with a strain of H. pylori related to the south Asian strain. At some point after Ötzi died, people arrived in Europe with the northeast African strain, and the two strains combined.Alternatively, Europeans might have started out with the northeast African strain. Ötzi might have carried a newly arrived strain from south Asia, which had yet to combine with the older one and spread across the continent.In either case, these strains had to come together with the ancient movement of human populations into Europe. “There had to be an intimate contact of these people,” said Maixner.But Mark Achtman, a microbiologist at Warwick Medical School in England, doesn’t believe any broad conclusions at all can come from the new study. For one thing, the bacteria come from a single person. “Go get 30 other mummies from around the world and get more data,” he said.Unfortunately, 5,300-year-old stomachs don’t grow on trees.For now, Maixner plans to study Ötzi’s bacteria to better understand how Europe’s two strains combined. He’s curious to see how some genes survived in the new chimera while others disappeared. The answer could potentially explain why Europeans suffer fewer complications from H. pylori infections than East Asians, for example.“It’s not easy to answer big questions immediately,” said Maixner. “We have to start to dig into the data in more detail.”center_img By Carl Zimmer Jan. 7, 2016 Reprints Biotech startup will mine the gut for drugs affecting human behavior While the geneticists were piecing together Ötzi’s genes, the anatomists made a surprising discovery: his stomach. It had migrated up into his rib cage, where it had been hidden from scientific view for 16 years. Tags bacteriamicrobiologymicrobiomelast_img read more

She’s calling for a health care revolution. The radical first step: listen to patients

first_img Lee called a meeting in 2012 to discuss how to track costs through University of Utah’s hospitals. The plan tumbled into place quickly: She rented some office space, put up a cube farm, and assembled a team of the hospital’s top accountants and data managers.She separated them from their day jobs and gave them six months to figure it out. On late nights, she bought them pizza.Lee kept a close eye on the project — and everyone in the health system knew it. When the data team wanted answers from medical staff, they got them.“We could just say, ‘We need you up at research park’ and they would be there,” said Charlton Park, chief of analytics at the University of Utah. “The whole institution knew about the project and that Dr. Lee was sponsoring it. … A roadblock was not something anybody wanted to be.”The resulting database was enormous: 200 million rows of information, each one as wide as football field.It documented the cost of every interaction with a patient: supplies used, medication dispensed, doctors consulted. The team determined, for instance, that a minute in the emergency room costs the health care system 82 cents. A minute in the intensive care unit costs $1.43. Please enter a valid email address. Related: It is something Lee believes deeply. Her management style is to set goals and let her employees figure out how to reach them. And she embraces ideas from her staff, too.At one of her hospitals, for instance, doctors hit upon the idea of building a day care for the maternity ward, so big siblings would have a place to play while the parents focused on their newborn.While describing it, Lee hopped up from her office chair and sketched the rough outline of the day care. “The guys who run the clinic just came in one weekend, took about this much space, and drywalled it themselves,” she said. “I just love that. They came up with it completely by themselves.”The University of Utah Hospital in Salt Lake City. A gleaming facade leads into a large atrium where a pianist plays in the corner, next to one of Utah’s busiest Starbucks. Kim Raff for STATMessage to doctors: Get thicker skinSo far, that management philosophy is working.Last month, University of Utah Health Care was named No. 1 for quality in a prestigious annual ranking of academic medical centers, beating out Mayo Clinic in Minnesota, Cedars-Sinai in California, and several other top institutions.Lee’s work has attracted gobs of attention, too. Harvard professors have visited to study the new cost accounting practices, and so has Sylvia Mathews Burwell, the Department of Health and Human Services secretary. Hospitals nationwide have begun replicating her methods to improve doctor performance and patient satisfaction.Dr. Thomas Lee, chief medical officer for Press Ganey, which administers patient surveys for University of Utah and other hospitals, still remembers his reaction when Vivian Lee told him she was going to start posting unedited patient reviews of doctors: “I said, “You are (expletive) kidding me?”“I couldn’t believe she was doing it, but at the same time I realized how great it was,” said Thomas Lee, who is not related to Vivian Lee. Privacy Policy Dr. Vivian Lee, University of Utah Health Care Related: Get a new body part and go home the same day: the rise of the ‘bedless hospital’ In late 2012, it became the first hospital system in the country to post unedited patient reviews of its physicians online. Right there, on the official hospital website, patients could, and did, accuse specific doctors of being rude, rushed, or always running late — and rank them on a five-star scale. (They also offered plenty of compliments.)Two years later, Lee’s staff built a database the size of multiple football fields to track the health care system’s costs to the penny, another unheard-of step in an industry where most hospitals have only a vague notion of how much they actually spend to, say, replace a knee, or deliver a baby, or evaluate a patient rushed in with chest pains.But Lee says this next step — giving patients the power to determine whether their care has been successful — is the one that matters most. It is also a massive undertaking.Physicians across the sprawling health care system are now collecting data from patients about how their illnesses affect their daily lives. The reports are instantly uploaded into electronic medical records, so everyone working with the patient can discuss those goals and lay out a plan to achieve them. Whether this effort, known as patient reported outcomes, will significantly improve performance is an open question.Talking ‘cow tipping’ at HarvardBut Lee is not the type of person you’d want to bet against.She grew up as one of the few Asian kids in Norman, Okla., where her parents both worked as university professors. Lee said she was not overly ambitious, and did not take Advanced Placement classes. She got into Harvard anyway, because she was gifted in math and a great test taker.When students in Cambridge asked her about Oklahoma, she indulged them with stories about cow-tipping that they actually believed.Lee earned a Rhodes Scholarship at Oxford, completed medical school at Harvard, and was a rare female surgical resident at Duke. In her first days in Durham, N.C., she vividly remembers an encounter with a woman handing out uniforms in the hospital laundry.“She gave me this white, triangle skirt — heavily starched,” Lee recalled. “It would have stood on its own. I said, ‘Can I just get some pants?’ And she said, ‘Honey, we don’t have any girl’s pants. You want those, you bring yourself over to the mall.’”Lee went and bought herself some pants. She opted not to pursue surgery, switching to radiology before finding her way into an administrative position overseeing research at New York University’s Langone Medical Center.In July of 2011, Lee took the top job at University of Utah, where she oversees a $3.3 billion annual budget. In addition to the hospitals and clinics, the system includes an insurance plan and five colleges within the university, including the school of medicine.A slight, energetic woman with a fringe of bangs across her forehead, Lee, 50, is warm and optimistic. She is a rare hospital administrator who easily breaks away from health care jargon to tell an amusing story. When she wants to emphasize a point, she lowers her glasses and looks at a person squarely, as if to chase away any doubts.Her health system’s flagship hospital in Salt Lake City is a mix of the old and new. A gleaming facade leads into a large atrium where a pianist plays in the corner, next to one of Utah’s busiest Starbucks. Arresting views of the mountains distract from the bustle of cars and ambulances.Lee’s days there are busy, but time at home is even busier. She and her husband have four daughters, ages 8, 10, 12, and 14.To clear the way for quality family time, she organizes like crazy. Lee cooks lasagna and curry dishes in bulk. She stocks a “birthday present closet” with books, glow-in-the-dark watches, and rolls and rolls of stickers that her girls can give as gifts when they’re invited to parties. There is no TV in the house, so time together is spent face-to-face.“I can’t guarantee that their socks match every day or that their rooms are neatly organized,” Lee said of her daughters. “I just try to spend time with them and have fun.”Lee works 12- to 14-hour days that are typically jam-packed with meetings and begin and end with a flurry of urgent emails. If she has time at night, she reads — about whatever grabs her attention. One of her recent selections was “Drive,” by Daniel H. Pink, which focuses on the art of motivating people. It asserts that certain workers, like those in health care, are intrinsically motivated and don’t need aggressive, top-down management. Raising an alarm, doctors fight to yank hospital ICUs into the modern era Related: Related: National Technology Correspondent Casey covers the use of artificial intelligence in medicine and its underlying questions of safety, fairness, and privacy. He is the co-author of the newsletter STAT Health Tech. @caseymross Within a year, Piedmont Healthcare in Atlanta and Wake Forest Baptist in North Carolina were also posting reviews. Others soon followed, including Geisinger Health System in Pennsylvania, Brigham and Women’s in Boston, and Cleveland Clinic.“We certainly didn’t have this level of transparency before” the University of Utah began posting its reviews, said Dr. Adrienne Boissy, chief of patient experience at Cleveland Clinic. “The idea that transparency can drive behavior change in clinicians, and in a market that didn’t think that way, was compelling.”Getting the reviews posted online wasn’t easy. Some doctors thought it was bad business and would undermine their reputations.“I remember my cellphone just burning,” said Chrissy Daniels, University of Utah Health Care’s director of strategic initiatives, who fielded angry calls from physicians. “I felt like crawling under my desk.”Lee attended a packed staff meeting to listen to complaints. Her response was direct: “We are going to need to get thicker skin.”Traffic to the University of Utah’s website has jumped more than 127 percent since patient reviews were first posted. And doctors’ national rankings on patient satisfaction surveys have improved.“Nobody likes to get negative feedback,” said Dr. Eric Volckmann, a bariatric surgeon. But he couldn’t ignore it: When patients complained that he kept them waiting, he tried to improve — or at least explain the delays to them. “It makes you look hard at your practices and think how you can do things better,” he said.A quest to track costs, to the pennyThe patient reviews grabbed plenty of national attention. But Lee said the decision to post them was the prelude to a more fundamental change. She wanted to shake up the relationship between the hospital’s doctors and patients, and make the cost of care a much bigger part of the equation.The problem in Utah — and at hospitals nationwide — was that no one knew how much it actually cost to deliver care to patients. Most hospitals calculate average per-patient costs that give them a rough idea of how much they are spending. But such data don’t tell you anything about what is driving the costs, where the waste is, or how to eliminate it without undermining the quality of care. Dr. Vivian Lee has been leading the University of Utah Health Care system in challenging the conventions of medical care and upending the relationships between doctors and patients. Kim Raff for STAT Newsletters Sign up for Weekend Reads Our top picks for great reads, delivered to your inbox each weekend. “We’re really going to start to define value in terms that matter to the patients.” During the last decade, her health system has repeatedly challenged the conventions of medical care and upended the relationships between doctors and patients. SALT LAKE CITY — Doctors in this mountain city are chasing answers that could transform medicine nationwide.Their quest is unfolding not in a lab or an operating room, but on the screen of an iPad that asks patients a straightforward question: What do you want from your care?A father with a bad knee might answer that he wants to dance at his daughter’s wedding. A woman with back pain might simply want to regain focus at work. It sounds so simple. But it’s a radical step in a health care system that traditionally defines success by technical benchmarks and government quality metrics — not by the patient’s own goals.advertisement It’s time to incorporate social needs into patient care It’s not just apps. Health care innovation requires true communication By Casey Ross Oct. 17, 2016 Reprints After about four months, Lee took the team’s work to a conference sponsored by the Robert Wood Johnson Foundation. She was not a featured speaker; she just had a slot on a small panel to present her new data tool.But her talk stirred so much buzz, the conversation soon took over not just her panel’s room but the large conference room next to it. “All these senior executives were saying, ‘Wow, I can’t believe you guys did that,’” Lee said. Many said they had tried to do the same thing but were told it was impossible.“It was really embarrassing,” she said. “There was just so much unexpected attention.”Weeding out wasted expenseOnce built, the database could be used to see how much different doctors spent to care for similar patients.Practices started to change.Surgeons who perform laparoscopic hernia repair, for instance, noticed a wide variation in costs, from $700 to $1,800. A deeper look revealed that some surgeons were using a $400 balloon dilator that didn’t appear to be associated with improved outcomes — a discovery that could end up saving the system hundreds of thousands a year.Orthopedic surgeons, meanwhile, noted that getting patients out of bed after joint replacement surgery could make a huge difference. That led to a staffing change to ensure that physical therapists, who typically worked 8 a.m. to 5 p.m., would be available for patients who got surgeries later in the day. They also started discharging a greater percentage of patients to their homes, instead of skilled nursing facilities, producing a drop in 30-day readmission rates. Leave this field empty if you’re human: The hospital also developed a new protocol for treating sepsis. Physicians began looking at the data of patients who developed the infection — and saw that they’d been missing some key warning signs.“That was jaw-dropping,” said Dr. Robert Pendleton, a hospitalist whose job is to prevent such infections.Physicians developed a composite index to track signs of sepsis and send an automatic alert to the nursing staff when a patient’s score gets to 7 or above on a 1 to 10 scoring system. So far, the hospital has seen a 4 percent reduction in mortality from sepsis and a dramatic improvement in the timeliness of treating patients, from nearly eight hours to under four.The next step, said Lee, is to bring patients more directly into the conversation about their care — and their expectations. The hospital plans to add that information to its existing data — and overlay it with quality measures designed by its own doctors and the federal government.Lee calls the resulting metric the “perfect care index,” a tool to measure which targets are met. Did the patient avoid infections? Did she regain mobility? Can she play with her kids?And once that’s done, the hospital can redesign its care, make it more affordable — and use the proof of its performance to compete with other top providers nationwide. “Then you would have this market force thing that we’re all looking for,” Lee said, “to drive care higher and better.” About the Author Reprints Casey Ross [email protected] HeavyweightsShe’s calling for a health care revolution. The radical first step: listen to patients “That’s the holy grail for me,” said Dr. Vivian Lee, chief executive of the University of Utah Health Care system, a network of four hospitals, a cancer institute, and 10 neighborhood clinics. “Now we’re really going to start to define value in terms that matter to the patients.”Lee has revolution on her mind.advertisement Tags hospitalpatientsphysicianslast_img read more

Coffee and intellectual freedom: 5 things I learned from my first year of grad school

first_img Mike Reddy for STAT [email protected] By Sara Whitlock May 30, 2017 Reprints This is it.After a year of classes and research rotations and all-nighters, I finally joined the lab where I’m going to get my PhD. This is a big deal — for the next several years this lab will be my home and the people in it my de facto family.To get here, I slogged through classes in the morning and lab rotations in the afternoon. The classes taught me the current state of biomedical science. The rotations were my chance to practice.advertisement Please enter a valid email address. Tags educationresearch Privacy Policy Most mountains are molehillsWhen you deal every day with complex problems (see #1), it’s easy to assume all the challenges you face require intricate solutions. And, yes, sometimes, the answer to a problem is complicated. But, sometimes, it’s obvious. Maintaining perspective on the scope of a challenge is critical for grad school success.During one of my lab rotations, an expensive piece of equipment broke and, naturally, it was when one of our collaborators from another university had traveled to Pittsburgh to use it. Stuff breaks, but the time-crunch had people running around wildly and calling expensive technicians to come quickly and fix it.As we huddled around the broken machine, I asked what I assumed was a naive question: If the machine is running, why isn’t the pressure gauge changing? It turned out that during routine maintenance, someone put a valve back on backwards. A quick flip, and we were back in business.An important lab skill? Social skillsThis is one every older scientist and adviser told me, yet it was hard to fully comprehend until I lived through the rotation process. As I entered grad school last fall and planned who I would work with, I thought I would bound from one incredible project to another and assumed the process would be pure scientific bliss. In many ways this was true, and I worked on three amazing projects. Leave this field empty if you’re human: But, I didn’t anticipate the emotional stress of adjusting to a new work environment every few weeks. Each lab has its own customs and style. The hours they work, whether they are talkative or quiet, how they prepare stock solutions and share lab duties — each time I entered a new lab I had to adjust to a different way of doing things.Sometimes, these expectations were communicated. Other times I had to learn by observation. Either way, for several weeks my entire schedule was upended as I changed when I slept and did my homework to fit the lab schedule. On top of this, each move meant meeting 10-15 coworkers and reporting to a new boss.In the end, social factors were as important in my lab choice as picking the type of science I want to do. I was told again and again to choose a lab where I felt like I “fit.” This was annoying back then, because I didn’t know what it meant. Now I’ve finally learned that “fit” means finding the lab and principal investigator that most closely match my work and communication styles, a place where I feel comfortable asking questions and sharing ideas with everyone. The scientific journey of grad school is going to be challenging enough, so it’s not a bad idea to take the interpersonal path of least resistance.Fact: Grad school is a marathon, not a sprintDuring college, my workload was finite. It often seemed impossible, but I had a set number of assignments to get done each day and week so I would do well in my classes. When I survived each 16-week semester, I could collapse in a heap of exhaustion on my parents’ couch, watching Netflix and sleeping 14 hours a day to recover.Not so in grad school. The classes I take have set assignments, but my work in the lab is infinite. Every waking moment could be another second spent reading a paper to learn more about my field or doing an experiment to answer a question. As excited as I am to learn the answers to my questions about how bacteria organize themselves, I can’t work 90 hour weeks for the next five years until I graduate. Somehow, I need to find balance so I can remain happy, healthy, and productive. And now here I am: a full-time scientist. Before long, I could be making exciting discoveries about how bacteria organize their innards using scaffolding proteins. I’m excited — I think it’s the coolest project this side of the Mississippi. Along the way this year, I learned a few things about myself, about science, and about relationships: Here are some of them.Coffee: It’s a food groupAs an undergraduate, I never pulled an all-nighter. Not once in four years.advertisement The intellectual freedom is intoxicatingMy boss likes to say that grad school is exciting because you get to choose your own adventure. I am ecstatic about having this level of intellectual freedom.This year I started that process by choosing the research area I want to work in and the people I want to work with. Now I’m trying to decide what big, unanswered questions I’ll try to tackle to get my PhD. I decided to become a scientist because I had endless questions about the world that my science classes helped explain. Many years later, I’m finally positioned to do work that answers some open questions, and I can’t wait to see how the next few years unfold.Coffee is a food groupDid I mention coffee? Well, it bears repeating.Sara Whitlock is a first-year graduate student studying structural biology at the University of Pittsburgh. Her column, Under the Microscope, can be found here. center_img Under the MicroscopeCoffee and intellectual freedom: 5 things I learned from my first year of grad school About the Author Reprints Watch: Drawing life at its start, cell by cell Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. Related: A new PhD student learns her first lesson: Certainty doesn’t exist in science Sara Whitlock But graduate school changed all that — if I went to a seminar or lecture without my brain juice, something was wrong.My coffee consumption reached astonishing quantities this year as I dug into classwork that was fundamentally different than what I did in college. In my classes this year, I was asked to design experiments and explain their results. Often, there were many ways to set up these experiments and several possible interpretations of the results. So I had to figure out the best answers, not the right ones. Even when I started early, these kinds of questions took hours of background research, meaning that I often worked through nights, fueled by liters of coffee, right up to deadlines. Related:last_img read more

Babies’ face scans detect exposure to low amounts of alcohol in utero

first_imgHealthBabies’ face scans detect exposure to low amounts of alcohol in utero Guidelines from most expert groups already suggest that alcohol and pregnancy should not mix. Nonetheless, many women choose to have a drink or a few during the course of their pregnancy (or before they realized they were pregnant). Ten percent of pregnant women in the United States reported having at least one alcoholic beverage during one month, according to a CDC survey published in 2015.But can a small amount of drinking by an expectant mother show itself on her child’s face?To answer that question, researchers in Australia analyzed three-dimensional images of over 400 children’s faces and heads around their first birthday. An algorithm automatically placed an array of nearly 70,000 points on those scans and looked for any substantial deviations from a standardized template made from all of the children’s scans. The children’s mothers also answered surveys about their alcohol intake several times before giving birth — data that researchers used to separate them out into groups based on when and how much they drank. Nearly 80 percent of the children in this study had some alcohol exposure as a fetus.advertisement [email protected] General Assignment Reporter Kate covers biotech startups and the venture capital firms that back them. Kate Sheridan Tags fertilitypediatricswomen’s health Related: Still, says Susan Astley, director of the Washington State Fetal Alcohol Diagnostic and Prevention Network, those findings aren’t surprising. “We’ve known for 20 years that the face [associated with FAS] is presented on a continuum,” she said. “In my opinion, they have not really contributed to the literature because they’ve made the reader think that most of the literature doesn’t exist yet.”The paper did have one important strength. “They probably have some of the better alcohol exposure documentation,” Astley said, because researchers asked mothers about alcohol intake a few times through the study period, likely collecting more reliable data than if they had asked about it after a child was born.“I’m a huge advocate of this 3-D analysis — I think there’s a great deal we could learn from it,” she said. However “I think the important public health questions are, even if they were finding something, will we ever be able to use this in clinic,” she said, especially since 3-D scanners are costly devices.Reinforcing a consensusThere are a few important limitations to keep in mind. The researchers only scanned white children for this study — which can lead to false signals when researchers try to apply results to other ethnicities. (A commentary accompanying the paper noted that work is ongoing to include Aboriginal Australian children in 3-D face scanning studies.)The American College of Obstetricians and Gynecologists states on its website that “there is no safe level of alcohol use during pregnancy.” The CDC and the American Academy of Pediatrics both concur — as does ACOG’s British equivalent, which updated its guidelines in 2016 to clarify that a woman would ideally abstain from alcohol entirely during a pregnancy. APStock By Kate Sheridan June 5, 2017 Reprints However, some women may have been advised by an OB-GYN that some drinking during pregnancy is acceptable. Despite ACOG’s guidelines, 40 percent of OB-GYNs said in a survey that some alcohol was fine. Nearly half said there was no clear consensus on alcohol’s effect during pregnancy.The researchers, for their part, believe that there is a consensus — and that their work further confirms it. “Prenatal alcohol exposure, even at low levels, can influence craniofacial development,” they wrote. “Although the clinical significance of these findings is yet to be determined, they support the conclusion that for women who are or may become pregnant, avoiding alcohol is the safest option.” About the Author Reprints @sheridan_kate The future is here: Virtual reality provides vivid look inside a fetus — but is it useful? Related: Currently, screening for children thought to be at-risk for fetal alcohol spectrum disorders — which includes fetal alcohol syndrome — is based in part on facial features. Health care providers often look for three classic signs: small eyes, a thin upper lip, and a flat area above the upper lip where there are typically two vertical ridges. (None of the children in this study had been diagnosed with a condition on the spectrum.)3-D facial scanning picked up some differences in those areas. It also picked up on one otherwise difficult-to-measure change called mid-facial hypoplasia, in which the center of the face develops more slowly than the eyes, forehead, and lower jaw. Perhaps most notably, there seemed to be slight differences in the mid-face and at the tip of nose even in the children of women who had only had a little to drink and only in the first trimester of their pregnancy. (However, almost no overall changes were statistically significant.) The results were published Monday in JAMA Pediatrics.advertisement Facial-recognition software finds a new use: diagnosing genetic disorders last_img read more

Astellas remains in the industry doghouse in the U.K. for bad behavior

first_img By Ed Silverman June 23, 2017 Reprints Astellas remains in the industry doghouse in the U.K. for bad behavior What’s included? Kristoffer Tripplaar/Sipa USA/AP GET STARTED Log In | Learn More Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. What is it? 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.center_img @Pharmalot 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. About the Author Reprints In a highly unusual move, the pharmaceutical industry trade group in the United Kingdom has extended a suspension given Astellas last year for another 12-month period, after finding the drug maker engaged in yet another round of egregious behavior.The latest infractions demonstrated “wholly inadequate oversight and control” at its U.K. and European operations and a “lamentable lack of concern for patient safety,” according a stern statement issued by the Association of the British Pharmaceutical Industry. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED [email protected] Pharmalot Tags pharmaceuticalsSTAT+last_img read more

Vaccine shortage stalls San Diego’s effort to battle hepatitis A outbreak

first_imgHealthVaccine shortage stalls San Diego’s effort to battle hepatitis A outbreak San Diego County, battling a deadly outbreak of hepatitis A, is postponing an outreach campaign to provide the second of two inoculations against the contagious liver disease until a national shortage of the vaccine is resolved, the county’s chief public health officer said.“Our goal is to get that vaccine in as many arms as possible for that first dose,” said Dr. Wilma Wooten, who is leading the fight against an epidemic that has ravaged unsanitary homeless encampments in San Diego County for the past year, sickening 544 people and killing 20 of them as of Nov. 6.Nurses and other county medical workers are fanning out across the most at-risk areas to offer onsite inoculations, and if they run into people who are due for the second shot, they will still give it to them, said Wooten, Public Health Director at the county’s Health and Human Services Agency.advertisement Leave this field empty if you’re human: Single-dose vials of the company’s VAQTA brand vaccine have been on backorder since May and weren’t available until last week, Eisele said. The company expects prefilled syringes to be unavailable until the first quarter of next year, she added.Likewise, GlaxoSmithKline has been struggling to fill orders for its Havrix brand of the vaccine.“It’s unprecedented, and it’s very large what’s happening,” said Robin Gaitens, a spokeswoman for the company. GlaxoSmithKline only recently received a shipment of prefilled syringes and has a “limited supply of vials in stock,” she said.“We will continue to work with CDC, the California Department of Public Health, which is coordinating vaccine orders and distribution on behalf of the counties, and our private customers in California to help address the needs in the state,” Gaitens added.San Diego County’s Wooten said that despite the supply constraints nationwide, the county now has enough vaccine on hand to give the first injection, but not the second, to those most at risk of contracting the virus — namely, the county’s homeless people, illicit drug users and the professionals who provide care to them.The biggest challenge posed by the San Diego outbreak is getting the vaccines to people in the transient homeless population, Wooten said. To help address that, the county has hired about 100 temporary nurses to supplement the public health nursing staff, nurse volunteers from local hospitals, paramedics and homeless outreach workers who are on the front lines of the vaccination effort.The city of San Diego has also been taking actions to curb the spread of the infection. In addition to spraying the streets in infected areas with a bleach solution, it has so far installed 78 hand-washing stations and 16 portable toilets for the homeless. By Stephanie O’Neill — Kaiser Health News Nov. 14, 2017 Reprints The two hepatitis A vaccinations, considered the best way to control the spread of the virus, should be administered six months apart. The first shot is the most important, Wooten said, because it protects people 90 to 95 percent of the time against the virus that causes the disease. The second shot raises the protection level to “close to 100 percent,” she said.So far, 90,735 people have received vaccinations in San Diego County — most of them the first of the two-shot series, according to the county’s health agency.advertisement Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. Nurse Paulina Bobenrieth administers a hepatitis A vaccine to a San Diego resident. Sandy Huffaker for STAT Related: In pain and with nowhere to go, homeless patients find respite in a writing group Trending Now: The deadly nature of the epidemics in San Diego and Michigan worries public health officials the most, said Dr. Noele Nelson, a CDC specialist in hepatitis vaccine research and policy. “The number of deaths in the Michigan and San Diego outbreaks are quite high from what we’ve seen in the past,” she told members of the CDC’s Advisory Committee on Immunization Practices at a late-October meeting in Atlanta.Hepatitis A is typically spread through the ingestion of fecal matter from an infected person — even in microscopic amounts. That can happen when people carrying the virus fail to wash their hands after defecating and then contaminate objects, food or water used by others. It can also spread through sexual contact.On Oct. 13, California Gov. Jerry Brown declared a state of emergency in an effort to increase the state’s supply of adult hepatitis A vaccine. The declaration allowed the state “to immediately purchase additional vaccines directly from manufacturers and coordinate distribution to people at greatest risk in affected areas,” the California Department of Public Health said.Before Brown’s emergency declaration, the department had distributed nearly 80,000 doses of the vaccine obtained through a federal vaccine program, but those supplies were insufficient, it said.Merck and GlaxoSmithKline sell the hepatitis A vaccine in pre-filled syringes and less costly single-dose vials.Pamela Eisele, a Merck spokeswoman, said the unexpectedly sharp rise in demand for the vaccine has limited availability of the company’s vaccine this year.center_img The city has also opened a public campsite with tents, sinks and restrooms for up to 200 people in a municipal operations yard downtown, said Katie Keach, spokeswoman for the city.Amy Gonyeau, chief operating officer of the Alpha Project, a homeless outreach organization that is operating the campsite for the city, said 181 people, including 40 children, are living there so far.Whether those efforts are making a dent in the spread of the hepatitis A infection isn’t yet known.“San Diego has reported fewer cases per week over the past two weeks than it reported previously,” the CDC’s Nelson said at last month’s advisory committee meeting in Atlanta. “But it’s too early to say this indicates a downward trend in the overall outbreak.”This story was originally published by Kaiser Health News.  An outbreak waiting to happen: Hepatitis A marches through San Diego’s homeless community Related: Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson Privacy Policy The San Diego outbreak, and a number of others in California and across the United States, have generated a spike in demand for hepatitis A vaccine and put a squeeze on supplies, according to the federal Centers for Disease Control and Prevention. Unexpectedly high demand worldwide has constrained availability outside the U.S. as well, the agency said.Merck & Co. and GlaxoSmithKline, the two companies with approval from the Food and Drug Administration to sell the vaccine in the United States, said they have been hard-pressed to keep up with the demand and are working to boost their production.The effects of hepatitis A can range from mild to fatal. In addition to the deaths in San Diego, an outbreak of the illness in Michigan has sickened 486 people and killed 19, as of last Friday, according to the Michigan Department of Health & Human Services.Los Angeles and Santa Cruz counties are also fighting the illness, and infections linked to California’s outbreaks are spreading to homeless people in Utah and Arizona, and to men engaging in gay sex in Colorado, the CDC said. In New York City, health officials are confronting a smaller outbreak, mostly among gay or bisexual men. Stephanie O’Neill — Kaiser Health News Please enter a valid email address. About the Author Reprintslast_img read more

Sanofi dengue vaccine was supposed to be a blockbuster; now, it’s the focus of a scandal

first_img 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] An effort by Sanofi to transform its dengue vaccine into a blockbuster product has, instead, turned into a scandal for the drug maker and a public health crisis in the Philippines, where the government is investigating why the vaccine was so widely adopted, despite studies suggesting its use would not be appropriate for everyone.The issue erupted last week when the company disclosed that a new analysis found its Dengvaxia vaccine could actually make future cases of the mosquito-borne virus more severe in people who were not previously infected. And so, Sanofi changed the product labeling to limit use to people who were not exposed to Dengue in the past. Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. GET STARTED By Ed Silverman Dec. 4, 2017 Reprints Ed Silverman Sanofi dengue vaccine was supposed to be a blockbuster; now, it’s the focus of a scandal What’s included? Log In | Learn More center_img What is it? Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED Pharmalot Herman Lumanog/Pacific Press/Sipa via AP 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. About the Author Reprints Tags pharmaceuticalsSTAT+Vaccines @Pharmalot last_img read more

Marinus Pharma finds the biotech imitation game can only last so long

first_img 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. It can pay to be a copycat — for a time.Consider Marinus Pharmaceuticals (MRNS), a little-known biotech that delivered the second-best stock performance in the sector last year. Why did Marinus enjoy an eightfold jump in its stock price in 2017? Because speculative investors viewed the company as a cheaper clone of high-flying Sage Therapeutics (SAGE). About the Author Reprints Adobe GET STARTED Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED What is it? 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. 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. Log In | Learn More center_img Marinus Pharma finds the biotech imitation game can only last so long Adam’s Take What’s included? Adam Feuerstein By Adam Feuerstein March 7, 2018 Reprints [email protected] @adamfeuerstein Tags biotechclinical trialsdrug developmentSTAT+last_img read more

Do you want to turn your bathroom into a medical lab?

first_img BOSTON — A startup called Confer Health wants to put a medical test lab on your bathroom counter. And a group of venture capital firms have just supplied $9.5 million to help it do that.The question is, do you feel like you need a medical test lab on your bathroom counter, in between the electric toothbrush and the soap dispenser? 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. Business Scott Kirsner — Boston Globe About the Author Reprints GET STARTED What’s included? Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED DAVID L. RYAN/GLOBE STAFFConfer Health’s Nate Hixon worked on a device that will allow consumers to conduct some types of medical tests at home. David L Ryan/Boston Globe What is it? Do you want to turn your bathroom into a medical lab? By Scott Kirsner — Boston Globe April 12, 2018 Reprints Log In | Learn More 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 diagnosticsmedical devicespatientspolicyresearchSTAT+last_img read more