Federal panel supports CDC guidelines for opioid prescribing

first_img By Ed Silverman Feb. 3, 2016 Reprints Related: Related: The meeting was held in response to criticism that the CDC draft guidelines were based on weak evidence and would unfairly restrict some patients from obtaining needed pain relief. The agency was also chastised for using a “secretive” process to formulate the guidelines, which some critics argued had violated federal law. As a result, the CDC delayed issuing the guidelines.As we previously noted, the guidelines were assembled last year in response to a long-running epidemic of opioid abuse and misuse. Every day, 52 Americans die from overdoses of opioid painkillers. In response, the CDC convened a group of outside experts to draft guidelines for primary care physicians, since family doctors and internists write the vast majority of prescriptions for these drugsadvertisement [email protected] CDC urges extra caution when doctors prescribe opioid painkillers “At this point, everything has been turned back over to CDC with the request for us to consider taking a closer look at the guideline recommendations where there were mixed opinions,” a CDC spokeswoman wrote us. Although she added the agency feels a sense of “urgency” about issuing its guidelines, there is no timetable for finalizing the proposal.advertisement The CDC guidelines suggest doctors prescribe opioids only after other treatments fail. The proposal also suggests doctors start patients on short-acting opioids — instead of extended-release, long-acting opioids — and initially prescribe the lowest possible effective dosage. The overall theme is to bolster physician awareness of abuse problems and encourage greater monitoring.But some critics charged the guidelines will be far too restrictive and, consequently, make it difficult for some patients to be treated with the most effective options. Last month, the National Institutes of Health’s Interagency Pain Research Coordinating Committee held a meeting and then filed an objection to the CDC, prompting the National Center for Injury Prevention and Control’s Board of Scientific Counselors to review the guidelines.It is worth noting that some critics who participated in the NIH committee meeting last month included patient groups that receive industry funding. Among them were the US Pain Foundation, the American Chronic Pain Association, and the Center for Practical Bioethics, all of which receive some funding from drug makers, including Purdue Pharma, which sells OxyContin.In any event, one CDC expert working group member said the suggested changes appear to be minor. Toby Talbot/AP After weeks of uncertainty, a federal advisory committee has endorsed controversial opioid prescribing guidelines that the Centers for Disease Control and Prevention proposed for physicians.During a meeting late last week, the National Center for Injury Prevention and Control’s Board of Scientific Counselors unanimously supported the recommendation of a CDC expert working group, although the committee did suggest modifying some of the language.center_img “The tweaks to the wording resulting from these debates do not materially or contextually change the intent of the initial guideline recommendation. Most of the wordsmithing suggested here is neither surprising nor inappropriate,” said Dr. Lewis Nelson, an emergency medicine specialist at the New York University Langone Medical Center.Meanwhile, one critic of the CDC proposal remains skeptical of the proceedings.“They seem almost unchanged, which makes me think the ‘review of the review’ was strictly cosmetic and that the fix was in and it still is,” said Peter Pitts, a former Food and Drug Administration official who now heads the Center for Medicine in the Public Interest. He noted that the FDA also voiced objections to the guidelines. “It will be interesting to see if the guidelines are further modified.” PharmalotFederal panel supports CDC guidelines for opioid prescribing Ed Silverman About the Author Reprints Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Obama administration wants $1.1 billion to fight opioid abuse @Pharmalot Tags CDCopioidspainkillerlast_img read more

Pressure mounts on Cleveland Clinic to cancel fundraiser at Trump resort

first_imgPolitics Pressure mounts on Cleveland Clinic to cancel fundraiser at Trump resort What’s included? GET STARTED Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED By Casey Ross Feb. 1, 2017 Reprints Log In | Learn More @caseymross Tags educationhospitalspolicypoliticsWhite House What is it?center_img Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. CLEVELAND — Hundreds of medical students and doctors have signed an open letter urging Cleveland Clinic to cancel a February fundraiser at the Florida resort owned by President Trump, after his executive order on immigration blocked one of the clinic’s doctors from reentering the US. The letter, with more than 400 signatures, also calls on the clinic to publicly condemn Trump’s order, protect the clinic’s employees from deportation, and reaffirm its commitment to diversity. Dozens of the signers are medical students at Case Western Reserve University, which operates the Lerner College of Medicine in partnership with the clinic. STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. [email protected] David Maxwell/AFP/Getty Images 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. About the Author Reprints Casey Rosslast_img read more

A millionaire’s mission: Stop hospitals from killing their patients by medical error

first_imgMasimo went public in 2007, and Kiani, still at the helm, is rich beyond his dreams. (Masimo’s board balked at his lucrative contract a few years ago and renegotiated, but he still takes in more than $5 million a year.)“His life story,” said retired California Senator Barbara Boxer, a close friend, “reads like a fairy tale.”But his business success wasn’t enough. The fight to open up hospital purchasing practices had stirred an activist bent in Kiani. He soon found his target.Masimo medical monitoring devices are seen on display on a wall at the company’s headquarters. Turning patient safety into a glitzy causeAfter years of working in the medical field, Kiani knew the grim statistics: Some 100,000 patients in the US die each year of medical errors, according to a 1999 Institute of Medicine report. Some researchers, using newer screening tools, think the number could be four times higher. Others say it’s lower.But everyone agrees these deaths can and should be prevented.When Kiani began to put faces to the statistics, he was shaken.One of those faces belonged to 11-year-old Leah Coufal, who died in December of 2002 at Cedars-Sinai Medical Center in Los Angeles. She’d had routine surgery to correct a mild chest deformity and apparently received a massive dose of fentanyl to control pain — enough to stop her breathing.Her mother, Lenore Alexander, couldn’t talk about Leah’s death for a decade. When she started speaking out, Kiani listened. He was shocked to realize his own daughter — who is fine now — had surgery in the same hospital, with the same surgeon, in the same week as Leah.“That could have been me,” Kiani told the people gathered at his first patient summit in 2013. “It could have been you.”He was also shocked to find Leah had not been monitored after surgery, not even with a simple pulse oximeter. Another name Kiani couldn’t keep out of his mind at the time was Rory Staunton, a 12-year old from New York who scraped his arm in gym class, then died from a sepsis infection that simple screening tools could have detected. By Usha Lee McFarling Feb. 13, 2017 Reprints Newsletters Sign up for Weekend Reads Our top picks for great reads, delivered to your inbox each weekend. Photos by Kendrick Brinson for STAT “It’s probably better he didn’t become a doctor. He wouldn’t have saved nearly as many lives.” National Science Correspondent Usha covers the toll of Covid-19 as well as people and trends behind biomedical advances in the western U.S. Leave this field empty if you’re human: And many in the field, even competitors, say Kiani’s work is making a difference, by turning a spotlight on the uncomfortable topic of patient death and also by reshaping market forces.“The pledge for open data does make an impact. Customers are starting to demand it,” said Stefan Dräger, the CEO of Germany’s Dräger, a medical technology manufacturer which signed up early on. He predicts more and more companies will jump in: “They have to,” he said. “It would look awkward if they refused.”Medtronic, a medical device giant, has started to embrace open platforms, including in some of its insulin pumps and glucose monitors. Another powerhouse, Philips, has been working to develop industry-wide standards so devices can talk to each other.Electronic medical records makers also need to come aboard, noted Johns Hopkins’s Pronovost, or they risk becoming “dumb data entry and billing systems” without access to the streams of data coming in from monitors and devices — or the powerful analytic tools used to make sense of it all.Ed Cantwell, who runs the nonprofit Center for Medical Interoperability, said it’s a national embarrassment that companies have been allowed to own patient data instead of sharing it. He’s working to create the architecture that hospitals could use to network their tens of thousands of devices into what he calls a “truly neutral, two-way plug and play” system. Once those standards are in place, he said, “I’m going to call vendors on their data pledges — very publicly.”  That can’t come too soon for Kiani. He’s already revved up about what it could all mean: Once more devices are linked and data is flowing, he said, computers should be able to predict in advance which patients are headed for trouble and alert clinicians. All that’s needed, he said, are a few good algorithms.“It’s easy for a computer to do,” Kiani said. “It’ll be phenomenal.” Usha Lee McFarling “I’ve seen very little substantive action coming from this particular patient safety organization. I don’t see the results to justify the costs.” About the Author Reprints Some critics also raise questions about the money Kiani has handed out to politicians. His foundation, which is funded by Masimo and other corporations, paid $315,000 to Clinton for a 2014 speech (though the former president has waived his fee for the past three years, Kiani said). Another of Masimo’s foundations has contributed $2.5 million to the Clinton Foundation.“That’s a lot of money. You wonder if it’s a way to legally channel money to a candidate,” said Beth Waldron, a patient safety advocate and consultant in Chapel Hill, N.C. She once hoped to work with Kiani on her key issue — death from venous thromboembolism, or blood clots — but grew concerned after looking at how the foundation operates.“I’ve seen very little substantive action coming from this particular patient safety organization,” said Waldron. She notes that plenty of other groups also work on patient safety and, in her view, get more done. “I don’t see the results to justify the costs,” she said.Kiani said he resents any implication that he’s trying to buy access to promote his company or alter tax policies that affect his industry. Former Senator Barbara Boxer Raising an alarm, doctors fight to yank hospital ICUs into the modern era Of course, making a pledge is one thing. Carrying it out is another. While smaller companies have been eager to open up their data, many heavyweights are moving slowly. Some cite concerns about patient privacy; others are working on big integrated systems to sell to hospitals and aren’t interested in cooperating with competitors. Makers of electronic health records have been especially reluctant.Yet outside experts such as Dr. Peter Pronovost of Johns Hopkins University, a world leader in patient safety, see glimmers of hope.Pronovost once thought it would take federal regulation to force companies to make their devices talk to one another, which he calls a crucial safety feature, akin to making sure a pilot can can check on the plane’s landing gear from the cockpit. He’s heartened by Kiani’s progress.“When Joe first stood up and said he’d make data open, he was the lone wolf in the industry,” Pronovost said. “Most of the others put their heads down and stayed silent. He’s been a visionary.” Zoll, which manufactures defibrillators and data systems in ambulances, was one of the first to open its data. Patient information captured in Zoll-equipped ambulances can now flow directly into the patient’s electronic health record, for review by hospital staff.As a next step, CEO Rick Packer is pressing the health records companies to send data to his ambulance devices, so paramedics have crucial background on the patients they’re transporting.“I use the data pledge as a moral high ground” in negotiations, Packer told a panel at Kiani’s patient safety summit last year. “Eventually it’ll come around and we’ll get what we need.”Kiani’s medical device company, Masimo, has its headquarters in Irvine, Calif. A science geek hits it richKiani runs his own medical device company, Masimo, from a building so airy and modern it stood in for Stark Enterprises in the first “Iron Man” movie.With a volleyball court in the lobby and hemp milk and artisanal chocolate served in the employee cafeteria, the building pulses with California startup vibe.Kiani, 51, a father of three with slightly silvering hair and a penchant for wearing dark tailored suits with no tie, lives in nearby Laguna Beach. But his life wasn’t always so easy.When Kiani arrived in the US from his native Iran at the age of 9, he spoke three words of English. His family settled in tiny Albertville, Ala., because his father, a technician, had a friend there. (Many who admire Kiani note he’s the kind of successful immigrant who might be barred from the US under President Donald Trump’s temporary immigration ban.)Kiani raced through high school, finishing at 15, and planned to become a doctor. But chemistry at San Diego State  University foiled him. Instead, he turned to engineering. @ushamcfarling “His life story reads like a fairy tale.” Joe Kiani, founder and CEO of Masimo, at the company’s headquarters in Irvine, California. Related: How one hospital is beating sepsis and saving lives “He really helped open up the market for smaller companies that had better, disruptive technologies,” said Ronald Newbower, an MIT-trained physicist who’s spent decades using technology to improve patient safety at Massachusetts General Hospital.As hospital purchasing rules began to change, Kiani’s company began selling huge numbers of pulse oximeters. It is now one of the top sellers in a market estimated at $1.5 billion globally.The company is moving into other areas, including brain monitoring. Kiani is extremely proud of Masimo’s technology and the sleek, iPhone-like devices he’s been creating of late. But the company took dings — and received an FDA warning letter in 2014 — for not adequately responding to complaints about some of its devices. Kiani said the company has since overhauled that process. Frederic J. Harris, engineer and mentor to Kiani Hospitals struggle to address terrifying and long-lasting ‘ICU delirium’ Related: [email protected] HospitalsA millionaire’s mission: Stop hospitals from killing their patients by medical error Medicare patient deaths shortly after leaving the ER raise questions about rural hospitals “It’s probably better he didn’t become a doctor,” mused Dr. Steven Barker, a professor emeritus of anesthesiology and aeronautical engineer at the University of Arizona who now works as chief science officer for Masimo. “He wouldn’t have saved nearly as many lives.”Soon after graduating, Kiani got a chance to work on pulse oximeters.  The geek in him was captivated. “I couldn’t believe you could shine light in your finger and measure oxygen in your blood,” he said. “I just loved the idea.”But devices being used in the mid-1980s were terrible. Just about any patient movement caused the devices to sound a false alarm that oxygen levels were low. Patients would then be blasted with too much oxygen, which often led to blindness in premature babies. “He wondered: “Why are people going into hospitals and not coming out?’” said Frederic J. Harris, an electrical engineering professor at San Diego State University who taught Kiani and remains close to him.Kiani decided to tackle such senseless deaths through engineering.“God bless him. He’s working on this and he’s got people all over the place working on it,” said Alexander, Leah’s mom, who has spent years pressing to get patients monitored after surgery. “I believe he’s a really good man. He’s not doing this for his own pocket.”Critics, however, look askance at the high glitz content of Kiani’s annual summits, run through his Patient Safety Movement Foundation.Held at beachside hotels, with splashy staging and tickets priced at $500 to $1,000 apiece, the summits rely heavily on political star power. (This year, for instance, the foundation is dangling a private fishing trip with Jimmy and Rosalynn Carter as a prize; health care institutions can enter to win by committing to specific steps to reduce patient deaths.) Trending Now: Drawing on what he’d learned from fields like submarine warfare and satellite communication, Kiani and colleagues came up with adaptive algorithms that helped the oximeters ignore signals that made no physiological sense. That cut down on false alarms and improved reliability. In 1989, Kiani and engineer Mohamed Diab launched Masimo. It began, as so many of California’s great companies have, in a garage.The next decade was tumultuous. Bigger companies were trying to steal his ideas. Kiani couldn’t seem to get hospitals to look at his device. At times, his sales reps were even physically escorted off hospital grounds.Joe Kiani, left, and Mohamed Diab discuss innovation projects at the Masimo headquarters in 1996. (photo courtesy Masimo) “It was so frustrating. I can’t even tell you,” he said.Kiani had stumbled into the scandalous world of hospital GPOs, or group purchasing organizations. His pulse oximeter was being locked out by larger competitors who paid hefty fees to hospital purchasing agents in order to land exclusive sales contracts.Kiani was initially afraid to get involved, not wanting his young company to be blackballed. “It wasn’t in my personal interest to try to change this industry,” he said. But he did speak out, in a series of high-profile articles and in testimony before the Senate in 2002. Beth Waldron, patient safety advocate IRVINE, Calif. — Joe Kiani likes to point out that the most worn spot on most medical monitoring devices is the mute button.He’s out to change that — and, he hopes, to stop the epidemic of preventable hospital death that kills tens of thousands of Americans each year.It’s not a glamorous cause. And Kiani is not a household name. But he is a multimillionaire with a proven track record of using engineering smarts to fix dogged problems; he made his fortune improving the humble pulse oximeter, which measures oxygen saturation in the blood. Now, he’s pushing a nerdy, but elegant, idea for saving lives: prodding manufacturers of medical devices and electronic records to open their platforms so all the systems can talk to each other.advertisement Related: Please enter a valid email address. “He wondered: ‘Why are people going into hospitals and not coming out?’” Dr. Steven Barker, chief scientific officer, Masimo In the past five years, Kiani has encouraged — some would say browbeat and publicly shamed — 70 companies to sign a pledge to open their platforms. The group includes some of the biggest medical device manufacturers — who also happen to be some of his most bitter corporate rivals.“It’s really surreal when I look at where we are,” Kiani said. “People who were our mortal enemies like Medtronic and Philips are now joining us.” Related: His tech fix — if widely implemented — could bring order to the cacophony of beeps, buzzes, and blaring alarms that can so overwhelm nurses and doctors that they push “mute” and miss true emergencies. It could make it easier for staff to monitor patients with complex needs. And it could flag, in advance, potentially fatal errors like incorrect dosing and drug allergies.Manufacturers, naturally, aren’t so eager to share their computer code. But Kiani is not one to give up.He stages a glitzy patient safety summit each year, attracting big-name speakers like Bill Clinton and Joe Biden to pound home the need for hospitals to stop killing their patients. “If President Clinton or Vice President Biden says it, it has far more weight,” Kiani said. “When I say it, it’s like a flea screaming.”advertisement Privacy Policy Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson Tags hospitalsmedical devicesmedical technologypatientsprofileslast_img read more

An interview with Bill Nye: ‘Respect the science!’

first_imgDon’t Miss @rickberke By Rick Berke March 14, 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. 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. Co-founder & Executive Editor [email protected] AUSTIN, Texas — For a generation of school kids, Bill Nye is zany and fun-loving, “America’s favorite scientist.’’A mostly flattering new documentary about the science educator, author, and mechanical engineer, which premiered here Sunday at the South by Southwest festival, chronicles how Nye drew inspiration from Carl Sagan as well as how he sparred with creationists and climate change deniers. GET STARTED Log In | Learn More center_img What is it? About the Author Reprints Rick Berke Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Tags CRISPRgeneticspolicyWhite House What’s included? Dave Kotinsky/Getty Images An interview with Bill Nye: ‘Respect the science!’ last_img read more

Shame won’t solve the opioid crisis. Corporate dissembling only makes it worse

first_img David A. Patterson Silver Wolf About the Author Reprints Related: Two years ago I answered an early-morning phone call. “He’s dead … he’s dead …,” my daughter kept repeating. “Oh, my God … no …”A friend who’d been sleeping on her couch lay face down on the living room floor. He’d overdosed on prescribed opioids. My wife and I stayed on the phone as emergency responders arrived. Medical professionals gathered around the young man. The police questioned my daughter. They searched her apartment.They found no illicit drugs — just a devastated young woman comforting her toddlers.advertisement Addiction is a disease, a medical illness, labeled officially as a “substance use disorder.” Yet too many of us still believe addiction to be self-inflicted — that people choose this life of shame, guilt, helplessness, and hopelessness. And those suffering from substance use disorders often internalize that belief.advertisement Related: Taylor Wilson’s parents fought for 41 days to get their daughter treatment. They couldn’t stop another overdose Secret trove reveals bold ‘crusade’ to make OxyContin a blockbuster Opioid use is dangerous and substance use disorder is very difficult to successfully treat. But effective treatments do exist, just as they exist for other medical illnesses. Suffering individuals and their families must not be shamed into silence. They must feel free to speak up and get the help they need.With the aid of medical and addiction professionals, I began to recover. I earned a bachelor’s degree and then a master’s in social work. I spent 15 years on the front lines, providing clinical, addiction-related services. Later, I completed a doctorate and now teach and research these issues as a professor at Washington University in St. Louis.My daughter’s friend was not so fortunate. Raised in Shepherdsville, Ky., he was an honor roll student at St. Xavier High School. But shortly after graduation, he was involved in a car wreck. He was prescribed opioids, became addicted to them, and soon began using heroin as well. For five years he wrestled with the illness, until the night emergency medical technicians carried his body from my daughter’s living room.He was 24 years old.David A. Patterson Silver Wolf, PhD, is associate professor in the George Warren Brown School of Social Work at Washington University in St. Louis. He chairs the American Indian and Alaska Native concentrations in the Master of Social Work program.center_img LUIS ROBAYO/AFP/Getty Images By David A. Patterson Silver Wolf May 16, 2017 Reprints First OpinionShame won’t solve the opioid crisis. Corporate dissembling only makes it worse This tragedy was one early pebble in the avalanche of opioid addiction now crashing into communities across our nation. In 2016, more than 55,000 Americans died from drug overdoses. The trauma is immeasurable. I understand the dynamic. Before I entered treatment in 1989, I, too, used alcohol and other drugs. At the age of 26, I felt guilt and shame for having ended up in a psychiatric hospital.I believed it was all my fault.Powerful external forces reinforce this message. Pharmaceutical executives deny responsibility for the opioid epidemic, even as companies like Mallinckrodt Pharmaceuticals, which makes the highly addictive oxycodone, pay multimillion dollar settlements. Their language is careful but revealing. They use terms like “misuse” and “abuse.” They argue that their products are “designed to heal, not harm.” They rarely concede that these products are inherently addictive.The Centers for Disease Control and Prevention paints a very different picture. A recent report by Anuj Shah, Corey J. Hayes, and Bradley C. Martin finds that, for those starting a course of opioid therapy, the transition from initial pain treatment to chronic, long-term continued use begins within days. Among individuals prescribed opioids for eight days or more, 13 percent were still taking them a year later. Among those given a monthlong prescription, that number rose to 30 percent.Neither corporate deflection nor uninformed assumptions about “personal responsibility” will solve this crisis. Indeed, such messages are profoundly unhelpful. [email protected] Tags addictionopioidslast_img read more

How a Supreme Court ruling on printer cartridges could have a big impact on drug prices

first_img About the Author Reprints By Meghana Keshavan May 30, 2017 Reprints Biotech Correspondent Meghana covers biotech and contributes to The Readout newsletter. Meghana Keshavan Tags drug pricinglegalpharmaceuticalsSTAT+ Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED What is it? A Supreme Court ruling on international printer cartridge sales could have major implications for, of all things, drug pricing and global health.The case in question involves patents, crucial legal protections for the drug industry. How a Supreme Court ruling on printer cartridges could have a big impact on drug prices Business center_img 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. 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. Jon Elswick/AP Log In | Learn More [email protected] @megkesh What’s included?last_img read more

Pharmalot, Pharmalittle: Perrigo CEO plans to retire as company faces pressure

first_img By Ed Silverman June 6, 2017 Reprints About the Author Reprints Log In | Learn More Alex Hogan/STAT Pharmalot [email protected] 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. What is it? What’s included?center_img STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Tags legalpharmaceuticalspolicySTAT+ @Pharmalot GET STARTED Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Pharmalot, Pharmalittle: Perrigo CEO plans to retire as company faces pressure Ed Silverman Rise and shine, everyone, another busy day is on the way. And it has been especially busy here on the Pharmalot campus, where the short person had to dash for the school bus and the official mascots spent time chasing chipmunks across the grounds. As for us, we are consumed with the usual ritual of foraging for interesting items. On that note, here are some tidbits. Hope you conquer the world today and, as always, do keep in touch. We like hearing secrets …Perrigo chief executive officer John Hendrickson plans to retire, slightly more than a year after he got the top job, Reuters writes. A specific date was not announced. Over the past year, the company has largely disappointed investors, reduced its earnings forecast due to pressure on its generic drugs business, and recently gave activist hedge fund Starboard Value board representation. In February, chief financial officer Judy Brown stepped down.last_img read more

Why doctor and hospital groups are fighting a measure to rein in drug costs

first_img By Casey Ross Oct. 19, 2017 Reprints What’s included? A Medicaid patient in Ohio prepares to take her medication. John Moore/Getty Images Tags policy CLEVELAND — In recent years, doctors nationwide have lamented ever-rising drug prices that are limiting patient access to crucial medicines and undermining hospital finances.But a ballot initiative in Ohio is flipping that script. Several prominent physician and hospital groups are joining pharmaceutical companies to oppose a proposal to rein in drug costs paid by state agencies. 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. Hospitals What is it? Casey Rosscenter_img About the Author Reprints [email protected] Why doctor and hospital groups are fighting a measure to rein in drug costs Log In | Learn More 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 @caseymross Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTEDlast_img read more

Roche snaps up Ignyta and its experimental lung cancer drug for $1.7 billion

first_img Tags biotechcancerdrug developmentpharmaceuticalsSTAT+ [email protected] 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. 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. Swiss pharma giant Roche (RHHBY) is buying the smaller U.S. biotech firm Ignyta (RXDX) for $1.7 billion in cash, picking up an experimental pill in the late stage of development that targets lung cancer caused by a rare gene defect.Ignyta is being acquired for $27 per share, the companies said Friday. That’s a 74 percent premium to Ignyta’s closing price on Thursday. Roche aims to close the deal in the first half of 2018. Biotech Log In | Learn More What is it? Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. First 30 days free. GET STARTED Lung cancer scans Andy Wong/APcenter_img About the Author Reprints Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. GET STARTED Adam Feuerstein By Adam Feuerstein Dec. 22, 2017 Reprints Roche snaps up Ignyta and its experimental lung cancer drug for $1.7 billion @adamfeuerstein What’s included?last_img read more

Can we get better at treating chronic illness? 3 ways to do it

first_imgHealthCan we get better at treating chronic illness? 3 ways to do it Related: Steering precision oncology toward great safetyOncology in 2017 resembles the auto industry, circa 1917: great new engines — that, in short order, revealed the need for equally good steering and brakes.When it comes to cancer treatment, the shiny new engines come in the form of drugs targeted to an individual’s genetic profile and immunotherapy.advertisement By Bob Tedeschi Dec. 22, 2017 Reprints Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson Tags agingend of life Adobe Doctors want to give their cancer patients every chance. But are they pushing off hard talks too long? Will cancer researchers build better safety features for these drugs in 2018?“I just got back from a panel meeting at the FDA, and they invited me to literally talk with them about the management of diarrhea,” said Eric Roeland, an oncologist and palliative care physician and researcher at the University of California, San Diego.“It just feels like in the oncology world, we’ve been so much more intolerant of these side effects in other areas,” he added. “If this were congestive heart failure or diabetes, we’d never allow for a year of diarrhea, but somehow we’re letting it happen in oncology.”With the FDA turning its attention to these side effects, Roeland said, drug makers and physicians will need to follow suit, funding research in this area alongside funding for new cancer treatment discoveries.“With diarrhea, we’re using drugs like tincture of opium, which was discovered by Hippocrates,” he said. “We’re still using it. That’s crazy.”Filling the palliative care workforce pipelineMedical systems are increasingly turning to palliative care specialists, who are experts in complex symptom management. One problem looms, though: There aren’t enough of them.By some measures, there are at least 11,000 fewer palliative specialists than are needed to care for the current set of patients, and possibly as many as 20,000. As medical systems look to push palliative care further “upstream” — into clinics and in patients’ homes, before they arrive in hospitals — the shortage will be felt even more keenly.Dr. Diane Meier, one of the pioneers of palliative medicine and co-founder of the Center to Advance Palliative Care, identified three areas where the industry should concentrate in the coming year to build palliative care capacity.center_img Trending Now: Roughly half of all adults in the U.S. have one or more chronic illnesses, with 25 percent suffering from two or more such conditions.These people navigate a medical system of widely variable quality, an ever-shifting insurance landscape, and real-world considerations like broken cars, broken marriages, and bad jobs that can shape the patient journey as much as the latest medical discoveries.Can we get any better at treating chronic illness, particularly when those illnesses become life-threatening? We spoke to some experts in the field on ways to make that happen in 2018 and beyond.advertisement STAT+: First, she said, increase funding for graduate medical education training slots for palliative clinicians, to bolster the ranks of specialists. Second, require medical and nursing schools to provide palliative training, or risk losing accreditation. Third, encourage more training for mid-career doctors who want to strengthen their palliative care skills.Will it happen? “All we’re doing right now is cutting budgets for everything,” she said. “This requires a commitment to spend money on the workforce for the future, which is … hard to be optimistic about it.”One ray of hope: The Palliative Care and Hospice Education and Training Act, which was introduced in March and would require the Department of Health and Human Services to support training and research for these medical specialties, attracted early bipartisan support.“For one reason or another it didn’t get hooked into any of the bills that were moving this year,” Meier said. “So I hope it will next year.”Breaking hospice out of the six-months-or-less boxWith studies showing that palliative care and hospice care can actually result in longer lifespans than aggressive end-of-life care, clinicians and researchers have pushed to have these services offered earlier in a patient’s illness, instead of in the final weeks.One huge hitch remains: Who will pay for it?Medicare, which could be targeted for future cuts, pays for most hospice care. But a growing number of patients are finding that these drugs can come with their own debilitating side effects, like gastrointestinal distress, autoimmune reactions, and cognitive impairments, among other issues, in some cases derailing treatment. Exclusive analysis of biopharma, health policy, and the life sciences. Edo Banach, the chief executive of the National Hospice and Palliative Care Organization, understands the fiscal realities, but sees a path where 2018 could show an expansion of hospice and palliative services: namely, as a way to help health care organizations save money on seriously ill patients.Banach said that patients who receive supportive services like spiritual care and social work visits tend to spend their last days at home instead of in the intensive care unit, thereby lowering the financial burden on patients and the health care system. Medicare only pays for such services through the so-called “hospice benefit” only when patients are in their final six months, but some insurers are offering their own hospice and palliative care benefits to patients earlier, because it can save money.Banach cited Blue Cross Blue Shield of California as one of the more aggressive insurers in this respect, and said that as he enters his first full year at the helm of NHPCO, he will work with more private insurers to follow suit, as well as companies that manage insurance on Medicare’s behalf.“There’s been so much discussion about care coordination, care management, non-medical supports and services, interdisciplinary care, person-centered care, all these buzzwords have been tossed around for people who have more than six months to live,” Banach said.“You sit around listen to some whippersnapper from McKinsey talk about getting these things into health care and I’m like, ‘Wait a minute. Have you ever heard of hospice?’”last_img read more