Insurers sued for denying access to hepatitis C drugs

first_img Ed Silverman About the Author Reprints PharmalotInsurers sued for denying access to hepatitis C drugs Tags Gilead Scienceshepatitis Clawsuits However, the treatments cost between $63,000 and $94,500, depending upon the drug and the regimen, before any rebates offered to payers. And the price tags helped trigger a national outcry over the cost of pharmaceuticals.For its part, Gilead, which is not named as a defendant in the lawsuits, has consistently maintained that its medicines offer good value because they lower the potential for long-term costs of treating liver disease, liver cancer, and transplantations.Nonetheless, payers continue to complain the drugs have been budget busters, and many have taken steps to restrict coverage. For instance, shortly after Sovaldi became available in early 2014, Illinois officials instituted two dozen stringent criteria for usage.This is the not the first time that consumers have fought back like this, though. Last year, consumers in California filed similar lawsuits against Anthem Blue Cross, claiming they suffered physical injuries, emotional stress, and economic damages, among other things, because access was restricted.Health care experts had predicted still more lawsuits would be filed while prices remain high. What remains to be seen is whether the arrival of a new Merck hepatitis C drug, which is priced at $54,600, will generate sufficient discounting so that insurers loosen restrictions. Related: Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. A spokesman for Group Health Cooperative declined to comment and we will pass along any reply that BridgeSpan sends us. [UPDATE: A spokeswoman for BridgeSpan similarly declined to comment, citing pending litigation.]The newest crop of hepatitis C medicines — Gilead Sciences sells Harvoni and Sovaldi, while AbbVie markets Viekira Pak — boast cure rates exceeding 90 percent. Their arrival over the past two years marked a turning point because older treatments were less effective and caused difficult side effects.advertisement [email protected] One health care expert thinks this is unlikely, though. “The fundamental issue is that it costs $54,000-plus. So it’s still a problem,” said Randy Vogenberg, a partner at Access Market Intelligence, a consulting firm that specializes in managed care.Meanwhile, some state officials are trying their own strategies to lower the cost of hepatitis C drugs. Last week, the Massachusetts Attorney General threatened to sue Gilead for violating consumer protection laws if the drug refuses to lower its prices. Gilead accused of manipulating HIV patents The prices of new hepatitis C drugs, including Viekira Pak by AbbVie, are at the center of litigation filed in Washington state against insurers who won’t cover the drugs except for “the most severely ill.” Nam Y. Huh/AP @Pharmalot The ongoing outrage over the cost of hepatitis C treatments is, once again, prompting consumers to fight back against insurers that deny them access to the medicines. In the latest instance, a pair of lawsuits was filed that accuse two large insurers in the state of Washington of rationing.The lawsuits, which were filed late last month in state court and seek class action status, charge that Group Health Cooperative and BridgeSpan restricted access to the medicines except to the “most severely ill” people, but not for a “clinical purpose.” Instead, the consumers charge the insurers do so due to “financial concerns.” And they want the insurers to provide coverage.BridgeSpan requires “infected individuals wait for treatment — potentially for years — until they demonstrate serious scarring or cirrhosis of the liver from hepatitis C infection,” one lawsuit charges. Meanwhile, patients are “forced to live with … an increased risk of cancer or death.” The lawsuit pointed to criteria for the coverage decision made by Regence.advertisement Related: Merck ushers in price war for hepatitis C medicines with new drug By Ed Silverman Feb. 4, 2016 Reprintslast_img read more

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Harvard Medical School eases rule on faculty ties to industry

first_img Harvard has one of the best medical schools. Why does it ignore family medicine? “Sometimes there may be a particular faculty member who’s the best person in the world to be involved in that research” — but can’t be involved if they have too much equity in that company, he said.Slavin said the change may help with a recruitment problem: “Some faculty don’t come because they perceive that Harvard Medical School has rules that are much too restrictive.”“These changes are relatively modest, but I think they’ll send a signal that we want to encourage these relationships with industry,” Slavin said. “If we don’t do so, we just aren’t going to advance medicine as quickly as we could.”Pulse of Longwood takes you inside one of the nation’s largest hubs of hospitals and biomedical research. Tags ethicsHarvard Medical Schoolmedical research Harvard Medical School is relaxing a conflict-of-interest policy that prohibits some researchers from conducting clinical trials on new treatments when they have a financial stake in the company developing them.The decision, which Dean Jeffrey Flier announced Thursday afternoon, affects researchers throughout Harvard Med and its teaching hospitals. Flier said the change was made because strict enforcement of the rule threatened to “stifle” the human testing of new drugs and devices.The school began reviewing its conflict-of-interest rules last year amid complaints by some researchers that the restrictions, which aim to protect scientific research from corporate influence, slow the process of turning laboratory discoveries into treatments. This is the second change the school has made.advertisement Dr. Aaron Kesselheim, an associate professor of medicine at Harvard who studies conflict of interest in medicine, said the new rules “continue to recognize that financial relationships with for-profit companies can influence” research.But he said “the devil’s in the details.”“If someone has a legitimate explanation as to why the rules need to be bent in their circumstance,” he said, “then I think that could work out.” But the impact of the changes will depend on “how serious they are about truly making it an exception, and not letting the exceptions swallow the rule.”Dr. Peter Slavin, president of Massachusetts General Hospital, Harvard’s largest teaching hospital, welcomed the changes.“I know medical school faculty here at MGH have been concerned that this rule was overly restrictive,” he said. “I presume this modest change in it will be well received.”“The most important thing we care about when doing clinical research is our integrity, and the safety of patients doing clinical research, but it’s probably not a good idea for the patients if the faculty member cannot do the research because of a modest” financial interest in a company, he added. By Melissa Bailey May 12, 2016 Reprints Harvard Medical School eases up on contentious ethics rule Related: The rule in question, established in 1990, prohibits faculty from conducting clinical trials on a company’s products if they have a certain amount of equity in, or earn at least $10,000 in income from, that company. That’s supposed to prevent researchers from skewing the trial results — and potentially harming people — because they have a financial interest in the outcome.But there was widespread concern in the Harvard Med community that the school was going too far with this strict prohibition, said Gretchen Brodnicki, dean for faculty and research integrity. She and a faculty ethics committee reviewed policies around the nation and found no other school with a “hard-stop” prohibition like that. Brodnicki said she has heard anecdotes of faculty leaving, or being unable to conduct specific studies, because of the rule, though she said the impact is hard to measure. As of Thursday, Harvard Med is creating more wiggle room in this rule. First, the school is raising the thresholds: Faculty will have to receive at least $25,000 in income (up from $10,000), or hold $50,000 in equity of a publicly traded company (up from $30,000) to trigger the prohibition on clinical research. Faculty still cannot hold any equity in a privately held company if they want to do clinical trials on that company’s product.Second, the school will now allow faculty to petition for an exemption if they’re over those thresholds and still want to do the research. If a faculty member applies for an exemption, Harvard Med’s ethics committee will weigh the potential benefits of the research against the risks.For instance, if a faculty member invents a device or is uniquely qualified to conduct research on it, then it might be in the best interest of patients to allow the faculty member to do the clinical trial, even if he or she owns equity in the company that makes the device, Brodnicki said.Flier called the change a “small tweak” that brings Harvard Med in line with guidelines from the American Association of Medical Colleges. “Our goal is to create situations in which we increase the likelihood” that research at the school turns into treatments that help patients, Flier said in an interview in his office Thursday. “One of the ways that that happens is by more interaction between faculty and industry.”Flier said the school has to balance the benefits of those interactions with the theoretical risks. He said the school will monitor the impact of the rule change and revisit it if need be.advertisement HealthHarvard Medical School eases rule on faculty ties to industry Related: Dr. Jeffrey Flier, Harvard Medical School dean Pat Greenhouse/The Boston Globe Could Harvard Medical School sell its naming rights for $1 billion? Related:last_img read more

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Cleveland Clinic CEO sends out warning to staff after doctor’s anti-vaccine column

first_img @caseymross Neides has since apologized for his column and issued a retraction, and the clinic has said it intends to take “appropriate disciplinary action” against him. But the wider damage is proving harder to contain, as Neides’s arguments were picked up by anti-vaccine supporters who are using it to advance their arguments.Cosgrove closed the note by saying, “Our good name is among Cleveland Clinic’s greatest assets. Please help us protect it. Thanks for your support and for all you do every day for those we serve.”A Cleveland Clinic spokesperson said in an emailed statement that the clinic still strongly encourages the use of social media by its caregivers to be “positive ambassadors” for the organization. “We also want them to be mindful that their personal views can impact the institution,” the statement said. “These are longstanding media and social media policies at Cleveland Clinic that we sent out as a reminder in light of this issue.”Correction: A previous version of this story incorrectly characterized Dr. Cosgrove’s consideration for secretary of the US Department of Veterans Affairs. Cosgrove was among those being considered, but withdrew. By Casey Ross Jan. 11, 2017 Reprints Dr. Toby Cosgrove, CEO of the Cleveland Clinic. Cleveland Clinic [email protected] Four things to know about the Cleveland Clinic doctor behind a controversial anti-vaccine column Cleveland Clinic reevaluating alternative medicine offerings amid uproar over vaccine rant Cosgrove is among the most well-known hospital CEOs in the nation. He is also a Vietnam War veteran. The clinic has endured days of negative coverage since the column was published last Friday and has already said it is reevaluating some of the products sold by its wellness institute.  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. Related:center_img He also directly addressed the arguments of Neides, director of the clinic’s Wellness Institute, saying, “These opinions do not represent evidence-based medicine, and the Cleveland Clinic remains committed to advocating for vaccinations to prevent the spread of communicable diseases.”The controversy exploded just weeks after Cosgrove withdrew from consideration to head the VA and while he was preparing to attend a prominent gathering of health care leaders at the J.P. Morgan Healthcare Conference in San Francisco. During Trump’s press conference, he said that Cosgrove and the Cleveland Clinic will be among the health care systems that will aid the administration in fixing problems at the VA. advertisement HospitalsCleveland Clinic CEO sends out warning to staff after doctor’s anti-vaccine column In his column, published by Cleveland.com, Neides wrote, “Does the vaccine burden — as has been debated for years — cause autism? I don’t know and will not debate that here. What I will stand up and scream is that newborns without intact immune systems and detoxification systems are being over-burdened with PRESERVATIVES AND ADJUVANTS IN THE VACCINES.” Adjuvants are added to vaccines to prompt a stronger immune response.In the column he identified himself a a Cleveland Clinic physician and the hospital system’s logo was above the text.The column provoked almost instant outrage on social media, causing public embarrassment for the clinic, a hospital system that collects $8 billion a year in revenue and is considered one of the top medical providers in the US. “Whether we realize it or not, every caregiver is a representative of Cleveland Clinic. How we engage in our lives outside of work can be linked back to our health system,” Cosgrove wrote, adding later, “in our world of social media, where every message has the potential to cause confusion and controversy, we must be mindful that our personal views cannot be associated with Cleveland Clinic’s.” Casey Ross About the Author Reprints CLEVELAND — Stung by negative publicity over a doctor’s anti-vaccine rant, the chief executive of the Cleveland Clinic penned a missive warning employees not to link their personal views with the hospital system.Dr. Toby Cosgrove, praised this morning by President-elect Donald Trump during Trump’s first press conference, cited the column by Dr. Daniel Neides without mentioning him by name in telling colleagues that publishing such discredited ideas under the banner of the clinic “has the potential to cause confusion and controversy” that could undermine its broader mission, according to a copy of the email obtained by STAT. Cosgrove was recently courted by President-elect Donald Trump to lead the US Department of Veterans Affairs and he sits on Trump’s President’s Strategic and Policy Forum. advertisement Related: Tags hospitalspatientswellnesslast_img read more

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Scientists, fishing for significance, get a meager catch

first_img Tags research Prakash Singh/AFP/Getty Although not iron-clad, biomedical scientists generally agree that a p-value of 0.05 suggests a high likelihood of statistical significance. And this is important. It’s what separates hyped-up-claims based on a single patient’s outcomes, for example, from carefully performed clinical trials on a large group of people. And it’s often the dividing line at which journals will publish a study and reporters will write about it.But, a pair of researchers argue in a recent issue of Science, the p-value may be doing more harm than good. Statistician Andrew Gelman, of Columbia University, and Eric Loken, a psychologist at the University of Connecticut, say scientists have bought into a “fallacy” — that if a statistically significant result emerges from a “noisy” experiment, a.k.a. one with many variables that are difficult to account for, that result is by definition a sound one.advertisement Once-promising diabetes ‘breakthrough’ comes unglued with a major retraction But, ironically, the very experiments for which we most need statistical help — that is, the ones with many variables interacting in complicated ways — are the ones where p-values are most likely to deceive. By Ivan Oransky and Adam Marcus Feb. 17, 2017 Reprints “Statistically speaking, a statistical significant result obtained under highly noisy conditions is more likely to be an overestimate and can even be in the wrong direction,” Gelman told Retraction Watch. “In short: a finding from a low-noise study can be informative, while the finding at the same significance level from a high-noise study is likely to be little more than … noise.”That kind of approach is how you end up with spurious correlations, such as linking the divorce rate in Maine with the per capita consumption of margarine. (What, that’s true?) Sometimes, this is referred to as p-hacking.And Gelman and Loken are not alone in worrying about it. Longtime statistician Frank Harrell, chair of biostatistics at Vanderbilt, says “p-values have done significant harm to science.” Yale kidney researcher and epidemiologist F. Perry Wilson has called p-values a “hoax.”But wait, says Steven McKinney, a statistician with British Columbia Cancer Agency Vancouver. Stop picking on the p-value, and pick on abuses of the p-value instead. “It’s not small p-values that are the problem, it is this repeated phenomenon of researchers publishing a result with a small p-value with no attendant discussion of whether the result is one of any scientific relevance and whether the appropriate amount of data was collected,” McKinney writes in a comment on Retraction Watch. “This is the phenomenon behind the current replication crisis.” Related: The real plague affecting science? It isn’t fraud Related: The WatchdogsScientists, fishing for significance, get a meager catch If we may, we think everyone involved has a point.Fortunately, there’s a path to liberation from p-value tyranny. Hilda Bastian, of the National Library of Medicine, offers a five-step program for avoiding “p-value potholes.” The first, and most obvious, is to recognize that statistical “significance” does not equal importance. “You can have a statistically significant p-value of an utterly trivial difference — say, getting better from a week-long cold 10 minutes faster. You could call that “‘a statistically significant difference,’ but it’s no reason to be impressed,” Bastian writes.Nor are p-values “truth,” says Bastian. They are evidence, yes, but not dispositive of anything. Conversely, a p-value above 0.05 might mean a lack of evidence, or it might not.Confused yet? Maybe that’s a good thing. Getting statistics right is difficult — and requires careful thought, not just slapping on a p-value and calling it a day. It wasn’t always this way; p-values are only about 350 years old. They’re not the laws of physics. That doesn’t mean we could or should throw them out — although some have — but it means we can make them work better for us. If you cast a wide enough net, you’ll find what looks like a prize-winning fish. But you’ll also catch a lot of seaweed, plastic debris, and maybe even a dolphin you didn’t mean to bring in.Such is the dilemma of interpreting scientific results with statistics. The net, in this analogy, is the statistical concept of a “p-value.” And a growing chorus of experts says that scientific research is using too wide a net — and therefore publishing results that turn out to be false. But is the maligned p-value really to blame?First, a little (we promise) statistics. At its very simplest, the p-value is what researchers use to assess the likelihood that, if a given result — the effect of a new medication, for example — wasn’t real, that you would get results like the ones you saw in your study. (If it seems that we’re having trouble explaining that in an easy-to-digest way, don’t worry, so do many experts.)advertisementlast_img read more

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‘What the 21st century demands’: designing homes to improve patients’ health

first_img LAS VEGAS — On a recent morning at this training ground for a new breed of interior designers, a lesson in empathy came in the form of a badminton game.Students strapped on eye patches and scratched-up swim goggles and took turns clumsily swatting the shuttlecock — an exercise meant to simulate the challenges of conditions like diabetic retinopathy and wet macular degeneration. Afterward, they talked about how to place windows, furniture, and guardrails to make it easier for people with vision problems to move around.The class here at the University of Nevada, Las Vegas, is part of a new master’s program — one of several sprouting up around the country — designed to train interior designers to use lighting, acoustics, and fabric to try to make day-to-day living easier for people with an array of medical conditions.advertisement Related: By Rebecca Robbins Nov. 3, 2017 Reprints The big challenge for the field: building up a body of evidence to support specific design choices.Some tactics have demonstrated strong promise in research studies, such as using natural lighting to help with mood disorders or installing walking paths to encourage exercise. But the studies are typically limited to six to 12 weeks, so it’s not clear if the effects are durable.Undergraduate student Alexis Tingey plays badminton while wearing glasses that simulate a visual disorder. Bridget Bennett for STAT“We have the neuroscience that tells us that these environmental factors have potential in preventing and treating illness,” said Dr. Dylan Wint, a neurologist and psychiatrist at the Cleveland Clinic’s Lou Ruvo Center for Brain Health in Las Vegas. But, he said, “we really don’t have a whole lot of evidence that designing these factors into someone’s lived space will actually do that.”Wint, who’s acting as a sort of neuroscience consultant for the Las Vegas students, laid out the key questions he believes the field needs to answer: “How do you design for health? And does designing that way really have this salutary effect? Or maybe that’s something you only see after six weeks and it fades after a while.”UNLV is building its health design program at a time when Nevada is rapidly graying.As of last year, about 15 percent of Nevada residents were over 65. That’s in line with the national average. But more than 20 percent of the people who moved to Las Vegas last year were over 55, according to the Las Vegas Global Economic Alliance, the region’s economic booster.Kopec leads a discussion during his “Built Environment and Human Health” class. Bridget Bennett for STATAnd Nevada’s over-85 population grew by 78 percent between 2000 and 2010, a rate outpaced only by Alaska.The man leading UNLV’s effort to train interior designers to serve this crowd is 75 years old — and thriving. Attila Lawrence still works full-time as a professor, though he plans to retire at 80, so that he’ll have more time to work in his garden.Lawrence spent years pushing to get the program off the ground. His motivation, he said, is simple: “It’s what the 21st century is demanding of us.” Related: Related: ‘Dementia-friendly’ communities take root across US “I don’t think [today’s students] want to design an operating room or a central sterile supply department,” said Rosalyn Cama, the emeritus board chair of the Center for Health Design.“But they’re very interested in other questions: How do you bring the farmers market into the lobby of a hospital? Or how you encourage people to take stairs and walk as opposed to taking elevators? And what orientation should a building be positioned in for good circadian rhythm?” she said.Some tricks of the trade seem obvious: Rails and handholds, for instance, can help patients with low vision navigate.But most of them are subtle. Designers learn to carefully evaluate how tall or shaggy the carpet is, or how busy its pattern is, so that people are less likely to trip. They strategically place windows or fireplaces as visual aids to help people stay balanced when they stand up. And they design stairs with just the right depth and color contrast to deter falls.Marisela Thompson, 25, is expected to be the first master’s student to graduate from the Las Vegas program next spring. For her thesis project, she’s studying how best to design homes where the elderly live with younger generations, focusing on details as minute as the placement of interior partition walls. Associate professor Dak Kopec puts on eyewear that simulates a visual disorder as he leads a discussion at the University of Nevada, Las Vegas. Bridget Bennett for STATcenter_img He teaches his students how to design spaces for people with muscular dystrophy, chronic lung disease, epilepsy, traumatic brain injury, autoimmune diseases, mood disorders, and chronic pain, along with visual impairment.Kopec’s office at University of Nevada, Las Vegas. Bridget Bennett for STATKopec stocks his office with teaching tools that you’d expect in a nursing school, not an interior design program. Among them: wheelchairs, walkers, stethoscopes, gait belts, blood pressure cuffs, elastic bandages, and a skeleton model. (“People always look at me funny. They ask: ‘You’re in a school of architecture?’” he said.)The Las Vegas program has enrolled about 10 master’s degree students since launching last fall; some courses are also open to undergrads. Florida International University, meanwhile, launched a new new master’s track in health care design this fall. And Texas Tech University is planning to kick off a master’s program aimed at both interior designers and architects next school year. (Tuition for the master’s programs generally runs between $12,000 and $18,000 for in-state residents.) Architect with ALS designs a residence he can control with just blinks Paving the way to a patient-centered approach in health care But increasingly, students want to do more than just work on institutions.“We look at health care as the care of people’s health, as opposed to just the typology of designing a hospital,” said Dak Kopec, who teaches the Las Vegas course that included the badminton game.advertisement There’s already a thriving niche of interior designers who specialize in hospitals, rehab facilities, and nursing homes. More than 2,000 professionals working in the field will gather this month in Orlando, Fla., for an annual conference put on by the nonprofit Center for Health Design. Health‘What the 21st century demands’: designing homes to improve patients’ health Tags dementiaeducationhospitalspatientsvisionwellnesslast_img read more

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How to reduce health care costs? Experts say lots of ideas, few successes

first_imgHospitalsHow to reduce health care costs? Experts say lots of ideas, few successes BOSTON — Whenever experts get together to talk health care, the issue of ballooning costs is never far behind.And an event in Boston hosted by STAT and The Atlantic was no exception, as experts wrestled with the multitude of challenges facing patients, clinicians, payers, and policymakers in the U.S. They shared evidence of what clearly doesn’t work to reduce the cost of care, and a few ideas of what it might make sense to try.The first to be dismissed was the idea of making patients smarter shoppers.advertisement Elizabeth Cooney As the political debate roils around drug prices, Chandra warned that if prices are squeezed by regulation, there will be a downstream effect that could shortchange tomorrow’s patients. “In the short run, if you want to reduce costs, we know rate-setting works. The question is, what would happen to quality, and future innovation?”Looking at other countries can be tempting, but it may not be wise to pick and choose pieces to adopt, said Chernew.“We have built a health care delivery infrastructure here, for better or worse, and we have to be careful … so the system doesn’t collapse,” he said. Leave this field empty if you’re human: And what about physicians?“Clinicians — physicians, nurses, and others  — they witness the financial toxicity of our system for individual patients,” said Steven Pearson, president of the Institute for Clinical and Economic Review, who is also a physician. “They want the health care system to take care of that.”“That” often means soaring drug prices.Most countries have systems in place to evaluate drugs and their value, unlike the U.S. Pearson, whose nonprofit group conducts similar analyses, argues that studies of whether one drug is demonstrably better than another will push progress. “If we do a better job discriminating, it will make companies go for the home run. The business model will reward those that try to innovate.”His organization concluded that a $475,000 drug for pediatric leukemia was worth its price. But a $75,000 drug for tardive dyskinesia, piggybacking on another rare-disease drug, was not.“If we can align price with value, you should be able to improve access to patients,” he said. About the Author Reprints The theory goes that “if you could just unleash consumers like you do in the Apple Store, they will figure out the best value,” said Amitabh Chandra, professor of social policy and director of health policy research at the Harvard Kennedy School of Government. “We’ve tried to find this result, but it’s just not there. Simply calling a patient a consumer doesn’t control spending.”Michael Chernew, professor of health care policy and director of the Healthcare Markets and Regulation Lab at Harvard Medical School, suggested looking at the way doctors are compensated. For starters, the fee-for-service system is mind-numbingly complex, he said. And it works against finding more efficient ways to treat patients because there is no reward for choosing a less expensive drug or procedure. “Changing the way physicians are paid will give them the incentive to become more efficient,” he said.advertisement Please enter a valid email address. By Elizabeth Cooney April 9, 2018 Reprints Tags patientsphysicianscenter_img Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson Privacy Policy General Assignment Reporter Liz focuses on cancer, biomedical engineering, and how patients feel the effects of Covid-19. [email protected] Adobe Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. @cooney_liz Trending Now:last_img read more

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IBM halting sales of Watson AI tool for drug discovery amid sluggish growth

first_img @caseymross By Casey Ross April 18, 2019 Reprints Log In | Learn More Citing lackluster financial performance, IBM is halting development and sales of a product that uses its Watson artificial intelligence software to help pharmaceutical companies discover new drugs, according to a person familiar with the company’s internal decision-making.The decision to shut down sales of Watson for Drug Discovery marks the highest-profile retreat in the company’s effort to apply artificial intelligence to various areas of health care. Last year, the company scaled back on the hospital side of its business, and it’s struggled to develop a reliable tool to assist doctors in treating cancer patients. 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. Exclusive 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 Casey Ross What is it?center_img 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. GET STARTED IBM halting sales of Watson AI tool for drug discovery amid sluggish growth What’s included? [email protected] David Ramos/Getty Images Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Tags Artificial Intelligencedrug developmentSTAT+last_img read more

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Insurer accuses J&J unit of using ‘sham’ patent litigation to extend monopoly on cancer drug

first_img About the Author Reprints Log In | Learn More By Ed Silverman April 22, 2019 Reprints What’s included? Insurer accuses J&J unit of using ‘sham’ patent litigation to extend monopoly on cancer drug 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. 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. Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. What is it?center_img GET STARTED @Pharmalot In the latest row over monopolies on medicines, Blue Cross Blue Shield of Louisiana filed a lawsuit accusing a Johnson & Johnson (JNJ) subsidiary of filing “sham” patent litigation in a bid to unfairly thwart generic competition to its best-selling Zytiga prostate cancer treatment.Having won an initial patent in 2004, Janssen Biotech three years later began pursuing additional claims with the U.S. Patent and Trademark Office, but was repeatedly rejected. By 2014, though, the subsidiary won an extension for one patent and was granted another, extending its monopoly on the drug until December 2016, according to the lawsuit filed last week in Alexandria, Va. Ed Silverman [email protected] Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED Alex Hogan/STAT Tags cancerdrug pricinglegalpharmaceuticalsSTAT+last_img read more

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Strong medicine is needed to solve America’s rural health crisis

first_img By Traci Marquis-Eydman July 25, 2019 Reprints Since 2010, more than 100 rural hospitals have closed, forcing people to drive extra hours to see a physician or seek medical care. Without the support of an area hospital, it’s difficult to replace independent physicians once they retire. Please enter a valid email address. Tags educationphysicianspublic healthrural health First OpinionStrong medicine is needed to solve America’s rural health crisis Leave this field empty if you’re human: Although it may be hard to entice city folks to live in the country, it’s possible if you start early. This is supported by data from the Washington, Alaska, Montana, and Idaho Program (now renamed WWAMI with the addition of Wyoming), that has been doing rural immersion programs for more than 25 years. These clerkships for third-year medical students combine six core components — primary care and family medicine, internal medicine, psychiatry, pediatrics, OB-GYN, and general surgery — in a continuous fashion over nine to 12 months instead of breaking them into traditional six-week “blocks.”This spring, I returned to Fort Kent as director of the Netter School of Medicine’s inaugural integrated clerkship for third-year medical students. For nine months, four medical students will work in the core components described above at Northern Maine Medical Center in Fort Kent and Northern Light AR Gould Hospital in nearby Presque Isle. (The nearest tertiary-care hospital is almost three hours away in Bangor).The students work with physicians and nurses as they see patients in the clinic, emergency department, operating room, and labor and delivery center. One of the advantages of working in a rural area is the absence of competition from residents and fellows. This offers ample opportunities for hands-on experiences that are often elusive in teaching hospitals — I’ve heard of third-year medical students finishing traditional obstetrics rotations without participating in a single birth.Another perk: The students will do all of this in a spectacularly beautiful setting.Regardless of whether these students decide to live in or practice in rural communities, they will emerge from the program with a new respect for rural hospitals and the joys and challenges of rural medicine.We need to marshal every resource to solve the looming health care shortage in rural America. Medical schools must create more programs to showcase the variety of options for physicians. Financial incentives must be provided so physicians who want to practice in communities of need can afford to do so. And we need to pass legislation on the federal, state, and local levels to support efforts to provide rural residents with the health care they desperately need.Traci Marquis–Eydman, M.D., is a family physician and director of the longitudinal integrated clerkship and rural medicine electives at the Frank H. Netter School of Medicine at Quinnipiac University in North Haven, Conn. Related: Growing up in the rural community of Fort Kent, Maine (population just shy of 4,000), I watched my parents struggle to find and keep a primary care physician. When I was young, this town in Aroostook, the state’s northernmost county, had a few die-hard general practitioners and surgeons, but as they retired I witnessed firsthand the toll their departure took on patients and families.I started dreaming of becoming a family doctor when I was 12. After medical school, I hoped to practice in a community like Fort Kent, but married a city boy from St. Louis who was tentative about rural life and tall snowbanks, and who wouldn’t go any further north than Connecticut.The health care situation in rural America has gotten worse since my childhood. Rural Americans face serious health disparities because of the shortage of physicians and the resulting lack of access to care. According to the Centers for Disease Control and Prevention, rural residents are generally sicker and poorer than urban residents, and are more likely to die from heart disease, cancer, unintentional injury, chronic lower respiratory disease, and stroke than their urban counterparts. Residents of rural areas who have cancer are diagnosed at later stages of the disease, have less access to clinical trials, worse outcomes, and spend 66% more time traveling to see cancer care providers.advertisement How great is the need for rural physicians? The National Rural Health Association reports a ratio of patients to primary care physicians in rural areas at 39.8 per 100,000, compared to 53.3 per 100,000 in urban areas. Family physicians, who make up only 15% of the physician workforce nationwide, provide 42% of the care in rural areas.And the problem will only get worse. A Perspective article in this week’s New England Journal of Medicine on the graying of the rural doctor population — more than half of them are now age 50 or older — forecasts that retirement will account for 23% fewer rural doctors by 2030.Most physicians tend to practice where they trained, and the majority of medical schools and residencies are affiliated with hospitals in urban areas. Rural salaries are also lower, and young physicians often factor loan repayment into decisions about how and where to practice. In its latest survey of medical school graduates, the Association of American Medical Colleges found that among the three-quarters of students in the class of 2018 who needed loans to pay for medical school, the median debt was $195,000.Presidential hopeful Joe Biden, on the campaign trail in northwest Iowa, made improving rural health care a key piece of his strategy for boosting rural America. Speaking at a hospital in Le Mars, Iowa, Biden said his top goals are to keep rural hospitals open and to reduce out-of-pocket expenses paid by rural Americans.He’s not the first to call for investment into rural health care. Several state and federal programs and proposed legislation also aim to improve it:The National Health Service Corps’ Loan Repayment Program repays the loans of primary care physicians in exchange for working — and earning a competitive salary — in rural, tribal, or urban communities with limited access to care.South Dakota has a recruitment assistance program that offers an incentive payment of $231,384 for qualifying physicians or dentists who make a three-year commitment to one of the state’s community clinics, and more than $66,000 for qualifying physician assistants, nurse practitioners, or nurse midwives.Alabama, which ranks in the bottom five states for health care, has several innovative programs including scholarships, a rural physician tax credit, and early pipelines to the medical and health professions that target high school students.The federal Rural Physician Workforce Production Act would, if passed, provide funding so rural hospitals could hire more residents. Currently, 99% of graduate medical education funding goes to recipients in urban areas.The bipartisan Training the Next Generation of Primary Care Doctors Act would authorize nearly $650 million over five years to train medical residents in low-income, underserved rural and urban neighborhoods. Coincidentally, the bill’s co-sponsor, Senator Susan Collins (R-Me.) is from Aroostook County.The American Academy of Family Physicians found that physicians who practice family medicine, have a rural background, and take part in rotations in rural areas while in medical school are more likely to choose to practice in rural areas. That’s confirmed by a study published in the Journal of Rural Health showing that an eight-week rural rotation was enough to give urban students positive opinions about living and working in rural communities. @QuinnipiacU center_img Privacy Policy Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. A pain in the night and a harrowing drive: A crisis in rural health care puts mothers-to-be on a risky road About the Author Reprints [email protected] Traci Marquis-Eydman Dr. Michael Sullivan, a hospitalist at the Northern Maine Medical Center, examines Rinette Theriault following her knee replacement, along with Zoe Frolking (seated), David Piscitelli, and Jessica Malhotra, third-year students at the Netter School of Medicine who are taking part in the school’s rural medicine clerkship. Joanne Fortin/Northern Maine Medical Center Seeking help in an emergency is one thing, but how many people will travel long distances for preventive care, or even prenatal and maternal care?advertisementlast_img read more

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As coronavirus spreads, doctors in the ER warn ‘the worst of it has not hit us yet’

first_img Doors lead into the emergency department at St. Barnabas Hospital in New York City, one of the areas hard-hit by Covid-19 in the U.S. Misha Friedman/Getty Images Swamy: We are in the storm, but the worst of it has not hit us yet. And we absolutely see it coming.Spencer: I didn’t see a single patient with chest pain. Not a single person with abdominal pain. I’m worried about where those patients are. Where are all the regular patients? Where did they go? What the heck is happening with them? And who’s going to be thinking about the non-Covid mortality, the impact of Covid on non-Covid patients?On how the disease presents:Ranney: Most people are going to be OK with this disease. Most people get a really bad cough and get some body aches, but go on to recover within seven to 14 days. But there is a portion of people, and it’s unpredictable who those people are, who get really, really sick.Swamy: When we have a unit full of critically ill patients who are often on ventilators and have medications running, the kind of attention that requires is immense on a moment-to-moment scale. The reason is our interventions are sometimes as dangerous as the disease. The ventilator isn’t something you can just set and forget. Once someone’s on a ventilator, there’s no margin for error. Especially with Covid.On shortages of PPE and medical equipment:Ranney: Almost all of our personal protective equipment is meant to be disposable. Instead, we are wearing procedural masks, surgical masks as long as we can. A week. Or two weeks if possible. We are reusing those N95 respirators between patients. So we take them off, we put them in a paper bag, and then we reuse them. These, of course, are all things that the CDC has recommended, so we’re [doing] what has become standard protocol. But it is not the way that this equipment is meant to be used. This does not feel normal. It feels scary. And it feels that there is a potential for error.Spencer: There are a lot of places that are quite short. So reusing your N95 when you’re not supposed to be or at least it’s not recommended. Trying to find different ways to reuse them. Baking them in the oven, UV light, etc. This is all kind of novel and certainly not ideal. But it’s always better than the latest CDC recommendation of last resort: bandanas and scarves.Swamy: There are non-invasive ventilation strategies, which can provide some amount of support for breathing and oxygenation, without needing a ventilator or a breathing tube. But the problem is that all of those things have some elevated risk of aerosolizing virus. If we had unlimited supply of protective equipment and if we had a better understanding of what this virus actually does in terms of aerosolizing, and if we had more negative pressure rooms, then we would be able to use more of these things. But right now we just can’t — because the worst thing we could do is spread the virus to more people. By Helen Branswell March 31, 2020 Reprints Streets in cities and towns across the country are eerily quiet. Car traffic has dropped so substantially air pollution is abating. In many places, people are hunkered down indoors, trying to avoid contracting Covid-19.But the true battle against the SARS-CoV-2 virus, which causes the disease, is playing out in hospitals that are currently — or will soon be — engulfed in an onslaught of patients struggling to breathe.The tsunami has crashed over Seattle, parts of California, New Orleans, and New York City. In Boston and other places along the eastern seaboard, the full force of the wave hasn’t yet hit, but it’s clear it is coming soon.advertisement “We are in the storm, but the worst of it has not hit us yet. And we absolutely see it coming.” Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. With masks dwindling, a hospital’s Covid-19 crisis team searches for a way out @HelenBranswell STAT spoke with three clinicians about what is happening in U.S. hospitals: Megan Ranney, an emergency physician at Lifespan Health Systems in Providence, R.I.; Lakshman Swamy, an intensive care doctor at Boston University Medical Center and the VA Boston; and Craig Spencer, an ER physician and director of global health in emergency medicine at NewYork-Presbyterian/Columbia University Medical Center. Spencer has firsthand experience with devastating infectious diseases: He contracted Ebola in West Africa in 2014.Their comments, compiled here, have been lightly edited for clarity and length.On the current situation in hospitals:Ranney: In Rhode Island, just like in emergency departments across the nation, we are seeing the number of cases double, and double, and double again. And that’s even with very limited testing. We are not running out of space at this point. We are really proactively setting up alternative facilities like tents to help us to take care of the increased numbers of patients that are coming in with Covid-like illnesses.Swamy: We’re not rationing care. But the terrifying thing is that we see it over the horizon. Because the patients keep coming. We’re in Boston, we’re not in New York. We’re hearing terrifying stories from New York. … It’s the same as what we hear in Italy, what we heard in China.Ranney: What hospitals in my region are seeing is that most patients can be cared for at home. But that’s a tough judgment for people to make on their own. We are, as a state and as a hospital system, working to set up alternative triage mechanisms to help keep people home if they can stay home without ever having to come to the hospital. Like telehealth, like self-triage programs, things like that. HealthAs coronavirus spreads, doctors in the ER warn ‘the worst of it has not hit us yet’ On the rapidly evolving response:Ranney: It’s almost impossible to wrap our brains around the degree to which our daily practice of medicine is shifting, truly day by day. The number of patients changes day by day. The protocols change day by day. The CDC’s recommendations change day by day. The treatment options change day by day. So at the same time we’re facing uncertainty about our own risk of getting ill, we’re also facing uncertainty about what the best current protocols are for assessing and taking care of these patients. Because there’s so little scientific evidence. And the patient volume is increasing so quickly.Spencer: We’re learning on the job. There’s not one single resource that says: “Are you taking care of Covid patients? These are the 78 things that you absolutely need to know.” There’s just so much information and it changes every single day. I remember looking last week at the number of journal articles that had already come out. It was like 12,200. Even if I had the abstracts for all of those, I wouldn’t be able to keep up.On the personal risk of caring for Covid-19 patients:Ranney: I have more than a dozen of my physician friends across the country, not in my own hospital but in Massachusetts, in New York, in Washington, in California, who’ve been diagnosed with Covid-19 at this point. So I know that I’m high risk.Swamy: Every time I go to the ICU I basically hug my family and take a picture of my kids. They don’t know, but in my mind, if I have an exposure, I don’t know if I’ll come home. I don’t know if I should. I don’t know where I’ll go. There’s just a lot of fear about that. Hospitals everywhere are surging their capacity, discharging any patients who can safely go home and attempting to conserve dwindling supplies of personal protective equipment, or PPE. Some are resorting to extraordinary measures — even going so far as to sanitize used N95 masks by baking them — to prevent health care workers from becoming Covid-19 patients themselves. Related:center_img What does it look like to be on the front lines of that response — and what can we expect to happen in facilities across the country in the weeks to come?advertisement Helen Branswell Related: Please enter a valid email address. Privacy Policy Tags Coronavirusphysicians Leave this field empty if you’re human: Ranney: I have friends who are doing things like recording videos for their kids just in case they get sick. My colleagues are scared.Spencer: For me it’s eerily reminiscent of the West Africa Ebola outbreak in 2014-2015, the mental anguish and anxiety of taking care of patients. I’m seeing a lot of my colleagues figuring out how to manage that. It’s really hard for physicians to kind of be vulnerable and we all need to be a little bit vulnerable right now.Ranney: I have children, I have parents, I have a spouse. We’re having daily discussions about whether I quarantine from them because obviously I’m getting exposed to people constantly in the emergency department. I’m also distancing myself from my parents, which they’re not happy about. But I just can’t risk them getting sick.Swamy: The tension is really high. I think the biggest fears I have are that my family will get sick, that I’ll make my family sick, that I’ll bring it home. That I’ll get sick. If I get infected, what am I going to do? How am I going to keep my family healthy? I don’t have somewhere to go to quarantine myself away.Ranney: This pandemic is going to change a generation of health care providers. It is going to change generations of health care providers. With masks dwindling, a hospital’s Covid-19 crisis team searches for a way out About the Author Reprints Lakshman Swamy, intensive care doctor in Boston Senior Writer, Infectious Disease Helen covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development.last_img read more

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