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Month: June 2021

Forget Trump. These folks came to the Republican convention to talk obesity

first_img @megkesh BusinessForget Trump. These folks came to the Republican convention to talk obesity Related: The newer experimental drug beloranib, made by Zafgen in Boston, ran into safety problems, too; just this week, the company announced it was dropping work on the product after two patients died in clinical trials.But there are about 10 weight loss drugs that are sanctioned by the Food and Drug Administration — and many physicians would like to see them deployed more effectively to treat obesity.Coverage, however, is often denied because “almost all insurers refer to obesity medications as ‘lifestyle’ medications,” said Dr. Eileen Seeholzer, director of weight loss surgery and weight management at Cleveland’s MetroHealth Medical Center.After all, the American Medical Association only recognized obesity as a disease in 2013.“Almost no one has access to effective FDA-approved medications,” Kahan said. “This is the biggest challenge we have to work on: We’re handcuffed.”For the most part, patients must pay for obesity medications out of pocket, Kahan said. Older, generic drugs like phentermine and phendimetrazine might just cost $30 to $40 per month, he said. Newer ones — like Qsymia and Belviq — tend to run $100 to $250 per month. Novo Nordisk’s obesity drug Saxenda, which is earmarked for use in morbidly obese patients, tends to run about $1,000 per month.A question of costWhile drug companies have set up rebate programs and assistance programs to help offset some of the costs for patients, it’s not enough to generate massive sales of the drugs. Getting insurers on board could help.“We’re hopeful that if this bill passes it will have a positive impact on commercial insurance as well — and [will get] obesity medications covered more broadly,” said Curtis Oltmans, corporate vice president and general counsel of Novo Nordisk.Panelists argued that giving more patients access to obesity drugs would lower health care costs overall.Seeholzer, for instance, mentioned a patient who began an obesity drug, and then was able to discontinue four other drugs, for high cholesterol, high blood pressure, heartburn, and diabetes. “And now she won’t get sick,” she said. “Weirdly, we’re waiting for people to get sick, and then band-aiding, and wondering why our results are less than we hope for.”The Medicare coverage bill has 158 cosponsors in the House and 12 in the Senate — with equal numbers of Democrats and Republicans, said Brian Branton, senior director of federal government affairs at Novo Nordisk. While there’s likely not enough time left to get it passed in this session, he said he has high hopes it will pass next year. The main hesitation he sees in lawmakers, he said, is concern about the cost of covering the drugs.“Our argument with policy makers: You could spend the money up front to treat obesity, or you could spend the money in the end — but if things keep going the way they are, it’ll bankrupt the country,” Branton said.This story has been updated to include information about the physicians’ ties to the obesity pill industry. About the Author Reprints M. Spencer Green/AP Over a lunch of turkey bacon and quinoa, organizers showcased patients who talked about their struggles with obesity and their pain at the perception that they simply lack the willpower to diet.“You leave your home, you’re walking down the sidewalk, and someone yells out of a passing car, ‘You big fat whale!’ and you keep walking,” said Patty Nece, a patient advocate. “That’s willpower.”Dr. Deborah Horn, medical director of the University of Texas Center of Obesity Medicine, said society extends far more sympathy to cancer patients and people with HIV, though obesity afflicts more Americans each year and can lead to dire health consequences. “In policy, how do we get the same level of compassion and support in obesity?” Horn said.Both Horn and Kahan have extensive ties to the obesity pill industry.Kahan received $259,644 last year from industry — primarily companies making obesity drugs, including $108,423 from Novo Nordisk, according to the federal Open Payments database. Horn received $83,675 in 2015 — with $51,060 of that coming from Novo Nordisk.A touch of celebrity dazzleThe event steered clear of partisan politics, though there was a bit of celebrity razzle dazzle as organizers brought in actor Billy Baldwin (who is no fan of Donald Trump) to introduce the panel. After that, though, it was heavy on policy, with a clear focus on getting the Obesity Act passed.Providers argued that the bill could help change the treatment paradigm for obesity — allowing patients to try drugs to help them lose weight before resorting to more extreme measures like bariatric surgery.Drug makers like Novo Nordisk, which stamped its brand on many of the brochures at the panel, like the bill too. Pharmaceutical companies have had an unexpectedly tough time selling a new wave of weight loss medications — and are eager for private and public insurers to start paying for the drugs.Why is covering obesity medication verboten? When the Medicare Part D bill was signed into law in 2003, the country was recovering from a series of weight loss drugs — fen-phen in particular — that wound up harming patients. That reputation still lingers — which is one reason why drug makers like Arena Pharmaceuticals and Orexigen Therapeutics have stagnating sales. “That kind of blanket exclusion is unscientific and counterproductive,” said Dr. Scott Kahan, a physician at Johns Hopkins University and director of the National Center for Weight and Wellness. “As a policy standard, it’s really silly, for the lack of a better word.”Along with Novo Nordisk, which happens to make a pricey obesity medication, sponsors of the event included patient advocates and physicians. They urged an audience of about 50 people, mostly of congressional staff and policy advocates to work toward passing the “Treat and Reduce Obesity Act,” a bipartisan bill that would allow Medicare to cover both medications and behavioral therapy.advertisement Biotech Correspondent Meghana covers biotech and contributes to The Readout newsletter. Drug makers struggle to revive interest in anti-obesity pills once seen as surefire hits By Meghana Keshavan July 21, 2016 Reprints [email protected] Once-promising obesity drug is scrapped after patient deaths CLEVELAND — The main hall at the Republican National Convention has been ringing all week with talk about terrorism, immigration, and national security.But in a side venue on Wednesday, a small crowd gathered to talk about a more intimate topic: obesity.Pharma giant Novo Nordisk cosponsored the “Rethink Obesity” panel here, and plans to cohost a similar event during the Democratic convention next week in Philadelphia. The goal: To push lawmakers to enact a bill, pending in Congress, that would lift a longstanding ban on Medicare paying for obesity medication.advertisement Related: Tags Congressdrug makersobesity Meghana Keshavanlast_img read more


Pharmalot, Pharmalittle: Lilly may cut jobs after Alzheimer’s drug failure

first_img Hello, everyone, and how are you today? We are just fine, thank you, despite a spot of rain descending on the Pharmalot campus. Our spirits, in fact, remain as sunny as ever. After all, as the Morning Mayor once said: Every brand new day should be unwrapped like a precious gift. So while you tug on the ribbon, you can also peruse the tidbits assembled below. Have a grand day and do keep in touch …Eli Lilly may cut staff now that a closely watched drug candidate for treating Alzheimer’s disease failed a late-stage trial, the Indianapolis Star reports. Wall Street analysts estimate Lilly spent hundreds of millions of dollars developing the drug in hopes of earnings billions in sales. Instead, the results “will cause us to reevaluate staffing decisions made in anticipation of positive results,” a Lilly spokeswoman tells the paper.Pfizer canceled plans to build a $425 million, five-story manufacturing plant in Ireland after the clinical failure of its cholesterol-lowering candidate bococizumab, the Irish Times writes. The drug maker had planned to employ an additional 350 people and make the drug at its Grange Castle site, where it currently produces two of its largest selling drugs — the Enbrel arthritis treatment and the Prevnar vaccine.advertisement About the Author Reprints Alex Hogan/STAT By Ed Silverman Nov. 29, 2016 Reprints Ed Silverman Amicus Therapeutics faces an extended delay of at least two years before a regulatory filing for its Fabry disease drug Galafold will be ready, TheStreet tells us. The Food and Drug Administration rejected a request to seek accelerated approval for Galafold based on existing kidney biomarker data. Instead, the agency told Amicus to conduct another clinical trial to gather new gastrointestinal symptom data in Fabry patients.Roche agreed to sell an API plant in South Carolina to Patheon for a nominal amount in a deal that will save about 200 jobs at the plant, WRAL TechWire reports.European Union and Japanese regulators plan to share details of active pharmaceutical ingredient manufacturing facility inspections, InPharmaTechnologist says.An Indian court will hear arguments in a case challenging $400 million damages given to Daiichi Sankyo after the Singh family was found to have concealed information about Ranbaxy Laboratories, the Economic Times says.Momenta Pharmaceuticals said its experimental biosimilar version of Humira met the main goal in a late-stage trial involving patients with a form of psoriasis, according to Reuters.The owner of Rid Pharmaceuticals and four other employees were acquitted in a case in which at least 28 children died across Bangladesh in 2009 after consuming Paracetamol syrup made by the company, BDNews24 says.The Korean antitrust regulator ordered Boehringer Ingelheim and Sanofi to sell animal health care assets in the country as a condition of their $25 billion asset swap, the Korea Times reports. Tags financeneurologypharmaceuticalscenter_img A World Health Organization working group recommends using the word “falsified” instead of “counterfeit” to describe spurious medicines, PharmaBiz reports. The draft report states that any concern related to intellectual property rights does not fall within this definition and that medical products should not be considered as falsified solely on the grounds that they are unauthorized for marketing in any given country.Japan will overhaul its prescription drug pricing system, according to the Nikkei Asian Review. The main focus will be to create an annual review of prices instead of every-other-year reviews. A public health insurance program covers a large portion of medical bills and drug prices are set by the government, which hopes the shift toward more frequent price reviews will reflect downward market trends and lead to lower government-set pricing.advertisement @Pharmalot PharmalotPharmalot, Pharmalittle: Lilly may cut jobs after Alzheimer’s drug failure Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. [email protected] last_img read more


Medicaid could struggle to cover breakthrough treatments under GOP’s plans

first_img What’s included? STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. A woman holds one of three medications she uses to treat her HIV. Medicaid has helped to stem emerging threats like HIV/AIDS, and advocates worry it will be hinder under Republican plans. Columbia Basin Herald/AP Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. WASHINGTON — Under the GOP’s vision for overhauling Medicaid, the program could struggle to afford expensive breakthrough treatments, cutting off its recipients from the latest medical innovations, warn policy experts and patient advocates.Republican plans to institute some kind of Medicaid spending cap would mark a fundamental change in the nature of the program. Right now, the federal government (with mandatory matching funds from the states, which actually administer Medicaid) pays whatever costs recipients incur for care that is covered by the program. What is it? Log In | Learn More GET STARTED By Dylan Scott Jan. 30, 2017 Reprints Medicaid could struggle to cover breakthrough treatments under GOP’s plans Politics Tags CongressMedicaidpharmaceuticalspolicylast_img read more


5 things I learned spending 10 days as a scientist

first_img By Leah Samuel June 15, 2017 Reprints In the Lab5 things I learned spending 10 days as a scientist At STAT, I often write about the work of biomedical researchers. So, in the interests of better understanding what I write about, I thought it would be a great idea to live and work like one.At the end of May, I was among a dozen science journalists who went to the Marine Biological Laboratory in Woods Hole, Mass., for a 10-day, hands-on immersion into scientific research. I was on the biomedical track, along with five other people. We were split into teams of three, looking at the effect of different drugs on the development of sea urchin embryos and looking at the effect of gene mutations on the development of yeast mitochondria. Understanding basic embryo development and cell biology is essential to understanding how diseases like cancer present themselves and even how drugs work.Here are a few lessons I learned in my stint as laboratory scientist.advertisement Here I am, playing scientist with other journalists at the Marine Biological Laboratory. Jamie DePolo Scientists kill thingsTo do our research, that meant getting sea urchins to hand over their sperm and eggs for our use. It wasn’t something we could talk them into, so, instead, we had to inject them with a shot of potassium chloride to get them to spontaneously release their white sperm or orange eggs as they died, slowly, in our hands.A few of us hesitated with our syringes of poison before tentatively pushing the thin needles into the sea urchins’ fleshy underbellies. Then we watched their wiggly spikes slow their movement, eventually becoming still as we held the creatures over tubes and seawater-filled jars to collect their gametes.Things kill scientists“Don’t accidentally stab yourself with that syringe; it will stop your heart,” one of the biologists warned us.We had to wear gloves to handle chemicals that could burn skin. Giant, brightly colored shower heads stuck out from walls or ceilings, ready to douse flames or rinse away contaminants. It turns out that lab accidents are not just supervillain back stories.For example, one MBL biologist told us about deadly centrifuges. Normally, these machines separate liquid from solid — blood cells from plasma, for example — by spinning at a high rate of speed on a rotor. But the old ones had a habit of detaching from their bases and flying about the lab, hitting bystanders. Even newer models can explode, or hit lab workers with flying metal and glass, or aerosolize deadly bacteria, viruses, or other nastiness.Findings don’t always mean answersIn one experiment, the teams had to look at samples of yeast cells with different mutations. We had to note what the cells looked like, and we had to count the dead or dying cells. Then, we had to pick different mutants to study further, based on which was the most dead or most damaged. Even though both teams were looking at the same mutations, we each picked different ones to study further.This was a surprise because we had assumed that we would have the same findings, that the mutations would affect the cells the same way and we would see those effects in the same way. That inconsistency gave us pause. But, our instructors assured us that this happens every day in scientific research. Biology is not concrete — scientists do experiments over and over again to test the same ideas. You tweak your protocol, adjust your hypothesis, get another cup of coffee, and try, try again.Fashion is an afterthoughtAfter breakfast, lunch, and dinner, we were in the lab. Workdays ran from roughly 10 a.m. to 10 p.m. But as the time wore on, makeup and coordinated clothing fell by the wayside.Those who had been wearing contact lenses were bespectacled after the second day. Sneakers were the easiest way to obey that “feet must be fully covered in the lab” rule. And hair? My longer-tressed colleagues sported hasty buns, ponytails, or stringy, post-shower clumps, while I corralled my afro into whatever scarf or headband I could find. Shadows grew on the guys’ faces while their heads got shaggier by the day.The sea urchins and yeast cells we were studying didn’t care what we looked like, so we didn’t either. Lots of stuff gets used only onceScientists can look sloppy (more on that later), but keeping an experiment from getting contaminated means that not much gets reused. The thin, rectangular glass slides upon which we had carefully set our samples for analysis came from under the microscope and went straight into the trash, along with the slides and samples that hadn’t been so carefully set.The pipettes we used to suction water and cells from one container to another required the use of disposable, plastic tips, which we tossed out even if they had only been used for water. Contamination can occur in a surprising number of ways. Scientists know how to avoid most of them. Journalists, um … don’t.advertisement Tags geneticsresearchlast_img read more


Merck shocks with CETP cholesterol study win; Ra Pharma’s scant PNH data

first_imgBiotech @adamfeuerstein Welcome to Readout Markets, where I’ll deliver news, analysis, and market chatter from the corner of biotech and Wall Street. Keep checking back, as I’ll be updating throughout the day.Updated at 4:17 pm EDT 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. By Adam Feuerstein June 27, 2017 Reprints 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. Adam Feuerstein Log In | Learn More What’s included? Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. First 30 days free. GET STARTED About the Author Reprints Merck shocks with CETP cholesterol study win; Ra Pharma’s scant PNH data [email protected] What is it? GET STARTED Tags biotechnologydrug developmentfinanceReadout MarketsSTAT+last_img read more


A makeover for oral PrEP: designing real-world HIV prevention for women

first_imgFirst OpinionA makeover for oral PrEP: designing real-world HIV prevention for women By Ann S. Kim Dec. 11, 2018 Reprints [email protected] Tags advocacyglobal healthinfectious diseasewomen’s health Please enter a valid email address. Around the world, more than half of individuals living with HIV are women. Young women are twice as likely as young men their age to contract HIV. Among 15- to 19-year-olds in sub-Saharan Africa, girls account for 3 of every 4 new infections. As a direct result, complications related to HIV are the leading cause of death among women ages 30 to 49.advertisement The V brand oral PrEP starter kit, which includes a compact pill-carrying case, lets women take charge of HIV prevention without fear of stigma. IDEO Cambridge When Manu (an alias of her choosing) got married, she never suspected her future husband had something to hide — something that would change her life and health forever. He came from a respectable family and had a good job. The only clue was perhaps the rushed wedding, which took place just 20 days after they met.Manu told me her story as we sat in her cramped bedroom in Delhi. She was sipping tea as I filmed the conversation. I kept my promise not to film her face. Revealing her identity was a risk she couldn’t take. It could mean her — and her parents — losing everything, including her job, their home, and their place in their community.A few months after the wedding, Manu discovered she was pregnant. She went to a doctor for routine blood tests. During what should have been a joyful time, the tests revealed her husband’s secret: He was HIV positive. And now Manu was, too.advertisement Ann S. Kim Author Ann Kim leads a group interview for feedback on early design concepts for V. IDEO CambridgeHIV passes more easily from a man to a woman than the other way around. But the risk isn’t explained through biology alone. The spread of HIV reflects the vulnerabilities and inequalities of what it means to live as a woman today.In South Africa, it is not uncommon to hear from women that their first sexual experiences were sexual assault. In India, the largest number of infected individuals are not truck drivers or sex workers, but housewives. How does a wife negotiate condom use with her husband without seeming to accuse her husband of infidelity?Wherever women have less power, less access to education and health care, and live in poverty, they have greater chances of acquiring HIV.Time and time again, women have told me they are waiting for a solution that would put them in control of protecting themselves against HIV. While there are microbicides on the horizon, like a vaginal ring and other delivery methods, the best and only prevention option right now is oral pre-exposure prophylaxis (PrEP), a formulation of the same medicines used for treating people who are HIV-positive.Yet simply having a rational understanding that HIV is a threat, or even having access to PrEP, isn’t enough to create a habit to take the medication. In communities where HIV is common, pills and medications carry stigma — a visit to a clinic, even for prevention purposes, can make onlookers think someone is already infected with HIV. Related: Privacy Policy Don’t let HIV ravage a generation poised to transform Africa About the Author Reprints Adherence to PrEP, the HIV prevention drug, is low. A new study suggests a pill with a tiny sensor might help Input from health care providers, the gatekeepers of oral PrEP, was key. We heard from doctors, nurses, and pharmacists working on the front lines of HIV treatment and prevention that the boldness and vibrancy of the V approach would help them better connect with the women they’re trying to reach.Designers believe that changing behavior starts by designing for a new mindset. With HIV and other afflictions, like addiction, mindsets are defined by stigma. In my work with the U.S. surgeon general, opioids and addiction were a high priority. While we created practical tools for clinicians, like pocket guides for prescribing opioids, the change we had to create alongside those tools was a reframing of addiction, from a personal failing to a disease.In the case of V, the design is more than the physical tools and resources around taking oral PrEP. The power lies in changing the way HIV prevention looks and feels for those at greatest risk of acquiring it. V transforms the traditional prevention message — “Don’t get HIV”— into a message of aspiration and self-determination: “Be empowered to care for yourself.” The vibrant, optimistic, visual design of the brand language is not just aesthetic; it changes the way women think about and relate to HIV and their own health.Whether it is HIV, addiction, or mental health, the same lesson comes up: Disease does not create stigma — it’s what humans inflict on one another. But the shame and isolation of stigma can be as harmful as the disease itself. As a patient once said to me, “Handling my HIV is fine because I have medicines. It’s the stigma that’s hard to manage.”In a world where women do not always have agency, my hope is that design-led solutions can transform prevention from a source of shame into an empowering ritual of self-care.Ann S. Kim is director of health and well-being at IDEO Cambridge. She is also the director and cinematographer of “Lovesick,” a new documentary about matchmaking for HIV-positive individuals. @ideo Related: As a designer in the health care and public health sectors — I was the first chief design officer for the Office of the U.S. Surgeon General under Dr. Vivek Murthy — I’ve encountered many different versions of Manu’s story. Through those narratives, I’ve come to see HIV/AIDS as an epidemic among women. Leave this field empty if you’re human: Designers in health care seek solutions that thread into everyday life. For example, IDEO, the company I work for, helped the online pharmacy PillPack develop what started as a tech solution — a better way of packaging and delivering medication — into a human solution that gives patients and caregivers easier ways to integrate drug regimens into daily life. In a similar vein, we knew we needed to take a holistic approach to designing PrEP for women. If we hyperfocused only on the “compliance” of taking a pill every day, we would miss the mark.With our collaborators at CONRAD, a research group focused on reproductive health, local partners in South Africa, and funding support from the U.S. Agency for International Development, we worked to develop an HIV-prevention approach that offers what women want and what works in their lives. We immersed ourselves in a collaborative design process with the diverse women we aimed to serve, and together created V, a new approach to oral PrEP for women, which launched this week.V was designed as an experience ecosystem that supports a woman’s journey, from her initial awareness of HIV to getting tested for it, accessing PrEP, and staying on it. V is meant to feel more like a branded self-care product than a medical treatment. This de-stigmatizes PrEP as a way to lower for women the barrier to taking it. For instance, the carrying case for PrEP pills resembles a lip balm case, holds a week’s dose, and is made from soft silicone that silences the attention-grabbing rattle of pills.During the design phase for V, we set up mobile storefronts to get feedback on our idea. Women (and some men) crowded around, so enthused by the concept that some even asked to buy the prototypes. In urban area and rural ones, the response signaled a hunger for something different. To support awareness of it, the V toolkit includes “Ambassador” parties, inspired by Tupperware parties, where women can speak in private and build group accountability around adherence. Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts.last_img read more


What not to say at J.P. Morgan, according to a conference veteran

first_imgBiotech What not to say at J.P. Morgan, according to a conference veteran Adam Feuerstein What’s included? Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED [email protected] @damiangarde What is it? 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. GET STARTED About the Authors Reprints We are a few days away from the start of the biggest and most important biotech business meeting of the year — the J.P. Morgan Healthcare Conference in San Francisco. If you sit through enough presentations at J.P. Morgan, you start to get buzz-phrase fatigue. Seemingly everything is a “transformational” “holy grail” of a “game-changer,” endorsed by “key opinion leaders” with “clinically meaningful” “optionality.”But it doesn’t have to be that way.center_img Mike Huckman, a global practice leader at the PR firm W20 W2O Group By Rebecca Robbins, Adam Feuerstein , and Damian Garde Jan. 4, 2019 Reprints [email protected] 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. National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. Damian Garde Log In | Learn More @adamfeuerstein 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. Tags biotechnologyfinanceSTAT+last_img read more


Vertex CEO says he will bring ‘new ideas’ to break a stalemate in the U.K. over a cystic fibrosis drug

first_img About the Author Reprints Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. What’s included? Ed Silverman What is it? Vertex Pharmaceuticals chief executive Jeff Leiden Dina Rudick/The Boston Globe [email protected] Pharmalot Vertex CEO says he will bring ‘new ideas’ to break a stalemate in the U.K. over a cystic fibrosis drug Log In | Learn More center_img GET STARTED During a widely anticipated U.K. Parliamentary hearing, Vertex Pharmaceuticals (VRTX) chief executive Jeff Leiden promised to offer “new ideas” for breaking a long-running stalemate over access to a cystic fibrosis medicine when he meets with a government official next week.“I’m going to come to the meeting with new ideas,” Leiden said about his planned meeting on Monday with Secretary of State Matt Hancock. “And meantime, we would guarantee access to patients at a discount to our list price. I want to get (a pair of government health agencies) back to the table. There’s no reason we can’t find a solution here in England.” By Ed Silverman March 8, 2019 Reprints Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED @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. 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 Bostondrug pricespharmaceuticalsrare diseaseSTAT+UKlast_img read more


Health insurers, like airplanes, need ‘black box recorders’

first_imgFirst OpinionHealth insurers, like airplanes, need ‘black box recorders’ When two Boeing 737 Max airplanes crashed within the span of six months of each other, killing 346 people, black box recorders helped investigators find the cause. A similar kind of black box should be available to alert regulators, lawmakers, or the public to deaths due to health insurance company behavior.Available evidence reveals that some commercial health insurance companies routinely fail to meet the health care needs of enrollees, although it’s impossible to know the full extent of the problem without more data. These companies hide their black box recorders — their internal records — even when they’re required by law to disclose them.Insurance-related casualties will never create headlines the way airplane deaths do. They happen one at a time, outside the public eye. We’re left to guess which health insurers rely on coverage guidelines and protocols that cause harm. American families are expected to blindly spend nearly $30,000 in out-of-pocket costs and lost wages each year for health care coverage that may be putting them at risk.advertisement Richard Eskow [email protected] Meanwhile, for several years, Medicare Advantage plans have failed to release accurate and complete data about the services their enrollees receive, as required by law. This information would help CMS hold these plans accountable for the care they provide.MedPAC, a nonpartisan agency charged with advising Congress on Medicare policy, has advised CMS to reduce payments to these plans until they turn over this information, as required by law. But CMS hasn’t done that yet, nor has it acted in any meaningful way to ensure these plans comply with the law.Health insurance companies, like airplane manufacturers, hold our lives in their hands. But, for the most part, health insurers — unlike airplane manufacturers — are allowed to operate in the dark. The little we do know is troubling. We must demand that health insurance companies come out of the shadows. One needless death is one too many, whether it occurs in a plane crash or as the result of insurance industry misdeeds.Diane Archer is the president of Just Care and the founder and past president of the Medicare Rights Center. Richard Eskow is a health policy adviser, a journalist, and a former chief writer for Bernie Sanders in 2016. Both are senior advisers at Social Security Works. All of United Behavioral Health’s clinicians disagreed with the company’s decision to ignore addiction treatment guidelines published by the American Society for Addiction Medicine. The attorneys who brought the case say they are aware of a number of deaths resulting from the denials of care, including two of the named plaintiffs, though the true number may never be known.advertisement Related: Diane Archer Commercial health plans that offer Medicare benefits, known as Medicare Advantage plans, provide further evidence that some health insurers secretly and systematically overcharge their members and deny them the care they need. The Office of Inspector General of the Department of Health and Human Services has reported “widespread and persistent [Medicare Advantage] performance problems related to denials of care and payment.”The Centers for Medicare and Medicaid Services, which is charged with overseeing Medicare Advantage plans, has cited more than half of the plans it audited for inappropriately denying care. Medicare Advantage plans were also cited for “charging incorrect copayments to enrollees for medical services.” CMS audits have led to sanctions for dozens of Medicare Advantage plans.In one particularly egregious instance, CMS barred Cigna from enrolling new Medicare Advantage members because its conduct posed “a serious threat to the health and safety” of its enrollees. “Cigna has received numerous notices of non-compliance, warning letters, and corrective action plans … over the past several years. … Cigna has not corrected issues of noncompliance,” the director of the Medicare Oversight and Enforcement Group wrote to Cigna.It is unusual for CMS to warn people with Medicare about health plans that pose serious threats to the health and safety of their members. Instead, it may continue to give high ratings to such plans. That means the public is misled about the risks of joining these plans, with the black box recorder again remaining closed on these grave deficiencies.The litany of wrongful and harmful behaviors by Medicare Advantage plans is surely greater than we know. The Government Accountability Office has criticized CMS for conducting insufficient oversight and audits of Medicare Advantage plans. Related: Tags insuranceMedicare Ghost networks of psychiatrists make money for insurance companies but hinder patients’ access to care About the Authors Reprints Even so, evidence is emerging that some for-profit insurers have placed profits above the health and well-being of their customers. For example, a judge ruled in March that United Behavioral Health, a subsidiary of UnitedHealth Group, used inappropriate coverage guidelines to systematically withhold potentially lifesaving mental health care from 50,000 enrollees. The judge found that United Behavioral Health’s failure to adopt widely accepted coverage criteria “was not based on any clinical justification,” adding that the only reason “was that its finance department wouldn’t sign off on the change.” Landmark ruling sets precedent for parity coverage of mental health and addiction treatment [email protected] By Diane Archer and Richard Eskow July 31, 2019 Reprints @rjeskow JULIAN STRATENSCHULTE/AFP/Getty Imageslast_img read more


With brain trauma, surgeons don’t always know if an operation will help. Could AI change that?

first_imgHealth Tech Jacquelyn Corley [email protected] GET STARTED With brain trauma, surgeons don’t always know if an operation will help. Could AI change that? A paramedic gurney flies through the trauma bay carrying an unconscious elderly gentleman. He is already intubated and has a hive of doctors and nurses running alongside, placing intravenous lines and injecting medicine into his blood stream. He’s suffered a serious head injury in a car accident. With every passing minute, blood accumulates in the space above his brain, pressing on vital structures.It was a cold winter afternoon in 2017, and the patient had been taken to a major regional hospital. When he arrived, the neurosurgeon on call had minutes to counsel the family on the man’s prognosis, and together they needed to decide whether to operate; surgery could save the patient’s life, but it could also commit him to a life dependent on a ventilator and a feeding tube, trapped in a coma or with limited brain function. Sometimes the quality of life matters more than just the presence of it. The challenge is how can doctors and family members make the right decision in these rushed and emotional moments. Log In | Learn More 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. 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. What is it? Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED About the Author Reprints Researchers are developing AI systems that would use CT scans and other data to guide treatment of patients with traumatic brain injuries. PHILIPPE MERLE/AFP/Getty Images What’s included? @JacquelynCorley By Jacquelyn Corley Aug. 14, 2019 Reprints Tags Artificial Intelligencehospitalsneurologylast_img read more