[email protected] About the Author Reprints Alex Hogan/STAT PharmalotPharmalot, Pharmalittle: Rising drug prices cost workers’ compensation programs By Ed Silverman April 5, 2016 Reprints Tags drug pricesGilead Sciencesopioids Good morning, everyone, and how are you today? A bright, shiny sun is enveloping the Pharmalot campus, although it is not yet enough to counteract the bitter cold. In fact, our short person, who is under the weather, is staying home to avoid the frosty air. As for us, we are keeping warm with cups of stimulation — our flavor this week is Mocha Java for those keeping track. Meanwhile, here are a few items of interest. Have a smashing day and keep in touch …Rising drug prices contributed to a 2.2 percent increase in pharmacy spending for American workers’ compensation payers last year, according to a report from Express Scripts, the pharmacy benefits manager. Opioids were the costliest type of medicine at $450.90 per-user-per-year, although on average, injured workers received 2.91 opioid prescriptions per year — down from 3.33 prescriptions in 2014.Gilead Sciences is paying $400 million to buy a subsidiary of Nimbus Therapeutics, which is developing a drug to treat an non-alcoholic steatohepatitis, or NASH, which is an increasingly common metabolic disorder that causes life-threatening fat buildup in the liver, the Associated Press writes. NASH can cause inflammation, cell damage, progressive scarring, and cirrhosis of the liver, and affects up to 15 million Americans.advertisement Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. @Pharmalot Ed Silverman The Indian Supreme Court is seeking a response from the Health Ministry concerning allegations that Ranbaxy Laboratories supplied adulterated drugs in the country, the Economic Times reports. A so-called Public Interest Litigation was filed by a consumer advocate who seeks to shut down three plants run by Ranbaxy, which is now owned by Sun Pharmaceutical.Sanofi launched the first public immunization program for dengue fever and plans to administer the world’s first licensed vaccine to 1 million schoolchildren, the Associated Press says.advertisement Catalent missed its forecast for returning a suspended softgel facility back to full production, but says production of essential drugs has begun at the French plant, Outsourcing Pharma reports.The Food and Drug Administration approved Descovy, a combination HIV drug developed by Gilead Sciences, according to Business Insider.Even as Indian regulators are upgrading their review standards, plant inspection reports show that Indian facilities had a high rate of data integrity issues last year, PharmaBiz writes.Pfizer reported positive Phase 3 trial results with its PCSK9-inhibitor cholesterol-lowering drug bococizumab, paving the way for a regulatory filing in coming months, PMLive tells us.UK regulators say that an Indian plant run by Rusan Pharma continue to break regulatory rules due to quality-control issues, according to InPharma Technologist.
All the patients appeared in beds, not chairs, during STAT’s tour, which took place on a Friday afternoon, not late at night, which tends to be busier. One patient was lying on a gurney in the middle of the emergency department waiting room — but he said he was on his way out the door and had waited only 15 minutes for treatment of a blocked catheter.“I have nothing to say against the hospital!” the patient, 65-year-old Telio Diniz, declared.Wait times aren’t as short for less urgent maladies. In another part of the hospital, Jorge Antonio dos Santos lay in a chilly shared room, wrapped in a fuzzy purple blanket, awaiting surgery. The 45-year-old handyman had swallowed a bone, which was stuck in his digestive tract. He got to the hospital at 8 p.m., but had to wait as surgeons tended to more severe cases — a shooting victim and an Australian tourist who fell. So he slept in the so-called “green room,” which has 16 beds for low-severity cases. About 20 hours later, he was still waiting, with his wife by his side.Souza Aguiar will have extra doctors on staff, including eight more surgeons, to handle the Olympic crowds, Orfão said. The hospital will also have some donated medical equipment from GE Healthcare on hand, but nothing compared to the Olympic Polyclinic, where athletes will be welcomed to a new 38,000-square foot space equipped with X-ray rooms, MRI scanners, and eight cryotherapy pools for athletes to dunk into cold water after they compete.Visitors who end up at Souza Aguiar, however, may rest their feet in a spot that the Olympic money can’t recreate: a vintage 1960s diner called Pronto Bar, offering thin-sliced Brazilian beef sandwiches and fresh mango juice.Rio-based journalist Thalita Pires contributed reporting. RIO DE JANEIRO — When the Olympics kick off Friday, ailing athletes will go to a sparkling new clinic built just for the games. Sick tourists, meanwhile, will be sent to a public hospital whose cramped communal quarters may come as a surprise.Municipal Hospital Souza Aguiar, housed in a gloomy 1960s building in downtown Rio de Janeiro, is one of five public hospitals officially designated to accept Olympic tourists. Spectators who attend the opening and closing ceremonies — as well as other sports in the Maracanã Olympic Zone, including soccer, track and field, and archery — will be directed to Souza Aguiar.A recent tour revealed some of the challenges the city and 361-bed hospital face as Rio tries to put on its best face for the games. Souza Aguiar has set aside 40 new beds in three renovated rooms to treat multiple victims in case of a major accident or terrorist attack. But remodeling hasn’t changed the reality at Rio’s largest hospital, in which patients worry about their security and spend nights sleeping just a few feet away from each other in cold wards. The hospital has no private rooms. advertisement By Melissa Bailey Aug. 3, 2016 Reprints Photos by Lianne Milton for STAT Related: Tourists are arriving during Brazil’s worst economic crisis in decades. The state of Rio de Janeiro in December declared a public health emergency, with hospitals closing units and running out of money for salaries, equipment, and basic supplies such as diapers and needles. But Souza Aguiar is run by the city, which is in better financial shape than the state. City officials say Souza Aguiar employees do get paid on time.In the face of allegations from local doctors that city hospitals are too overcrowded to handle Olympic visitors and lack basic supplies, officials at Souza Aguiar insist they’re ready.advertisement An open letter to Olympic athletes about Zika The Olympians can leave. Brazil’s poor live with filthy, reeking water every day Jorge Santos, 45, waits to be treated with his wife, Izabela Coelho, 18, at the Municipal Hospital Souza Aguilar. The front entrance of Municipal Hospital Souza Aguiar. Dr. Letícia Louzada (left), chief of emergency medicine, and Dr. Lucia Orfão, hospital vice-director, in the lobby of the nonsurgical emergency room. Outside the hospital just after sunset one recent day, a row of homeless people lay wrapped in blankets, huddled against the fence that separates the hospital from the street. A car slowed and a woman started handing out aluminum plates of food, which were quickly snatched up.Tourists arriving to the hospital will likely pass the front entrance, turning into the ambulance bay that leads to the emergency room.That’s the same spot where, on June 19, armed attackers freed a suspected drug kingpin named Fat Family, who had been in police custody there. In a blaze of 28 bullets, one patient died, and a nurse technician was severely wounded when he was struck by a bullet in the abdomen while talking on his phone.During the recent tour, one patient, 52-year-old Vivaldo Souza da Silva, told STAT he was lying in a hospital bed that June day, recovering from a toe amputation, when he heard a flurry of gunshots. He said he became worried when he found out the attack occurred at the hospital.Hospital officials emphasized that the shootout was outside the hospital doors, in an area that should be monitored by police.“Police knew about the rescue. They should have closed the perimeter,” said Dr. Lucia Orfão, vice-director of the hospital, who led STAT around the hospital. Tags hospitalsOlympicstrauma care Related: She said Fat Family, who was waiting for facial surgery from a gunshot wound, couldn’t be transferred to another hospital. In the future, she said, the hospital aims to speed up medical care for patients in police custody to reduce the risk of another conflict or escape. Mental health counselors are working with staff who are reeling from the attack, Orfão added.The hospital has experience with mass casualties, treating patients from a fatal tram derailment in 2011 and a dramatic fence collapse that injured dozens at a nearby soccer stadium in 2000, Orfão pointed out. To prepare for the Olympics, the hospital has trained staff to respond to tragedies with multiple victims, she said.With up to half a million visitors set to descend on the city for the games, keeping them healthy could be a big job. Officials are preparing to treat an estimated 20,000 people during the games. But Brazil’s health minister predicted most will be treated at pop-up clinics at the Olympic venues, and only about 700 will need to visit a hospital.Orfão rattled off a few likely causes that will bring them in her doors: drinking too much, drug overdoses, broken limbs, or trauma from fighting or falling. The Zika virus, which has prompted international alarm and spurred some athletes, spectators, and commentators to skip the games entirely, wasn’t even on her list. (Because it’s winter, the number of cases is expected to be very low — way less likely than getting the flu.)Telio Diniz, 65, is wheeled through the lobby of the emergency room. Souza Aguilar is one of five hospitals designated by the city of Rio de Janeiro to treat tourists during the 2016 Olympic Games. Patients Osvaldo Portela (left), 71, and Vivaldo Souza da Silva, 52, both hospitalized for infections of their amputated toes, slept next to each other in a shared cubicle. Besides having extra translators on hand to guide them, tourists entering the hospital won’t be treated differently than the everyday Brazilians seeking care there, Orfão said — patients like da Silva. A painter who lives an hour away from Rio, da Silva sat on a narrow cot taking bites of plain white bread. He shared a small bay with a man who shared the same affliction: after having their toes amputated due to diabetes, the wounds had started bleeding again.The two men slept just a few feet from each other in a wing designed for patients with medium-severity medical conditions. Patients are separated by gender into two communal rooms. There are supposed to be 18 beds, one patient per bay, but the wing routinely has 40 patients instead, Orfão said.The man da Silva slept right next to, 71-year-old Osvaldo Portela, didn’t complain. He called the medical care “wonderful” and said he slept very well.Pronto Bar, a vintage 1960s diner, is on the hospital’s ground floor. But a report issued July 18 from a local medical council, CREMERJ, cast the hospital in a different light. CREMERJ, which licenses and oversees doctors in the state of Rio de Janeiro, claimed all five hospitals designated to receive Olympic tourists are too crowded to handle the foreign visitors. Souza Aguiar and its adjacent regional emergency center don’t have the resources to handle their typical number of patients, who are sometimes put in improvised furniture such as chairs and ambulance stretchers, the report charged. The report also said there’s a shortage of medicine, and of equipment for monitoring critically ill patients.City officials dismissed the report as a politically motivated attempt to disparage the public health system, but declined to specify the motivation. A city spokesman said the hospital has been planning for the Olympics for four years and has all of the resources it needs to treat patients. City officials noted that Rio hospitals have already handled other events with huge crowds, including Carnival, New Year’s Eve, and the World Youth Day.Orfão conceded her hospital is “a little bit crowded, because the demand is high.” But “we don’t have patients in the hallway,” she said. Related: WHO doesn’t see need to delay or move Olympics over Zika fears HealthIf you get sick at the Olympics, don’t expect a private hospital room In one communal area in a trauma wing, two patients lay in beds across the room from a dead body. The patient had just had a heart attack on a bus. His body lay in a gray bag, zipped up to his armpits, visible to anyone in the room. As visitors walked through, one of the doctors leading the tour drew closed a curtain around him.
A large private insurance company and at least five state Medicaid programs are now pushing alternative epinephrine auto-injectors instead of the branded EpiPens.Cigna, an insurance company that serves about 15 million patients, recently changed its policy: Branded EpiPen and Adrenaclick auto-injectors will no longer be covered without a “prior authorization” from the company. Additionally, in at least three states, Medicaid recipients must obtain prior approval before buying one of the brand-name auto-injectors with insurance, and in at least five states, EpiPens are only covered with a prior authorization. Tags drug pricingMedicaidpharmaceuticalsSTAT+ What is it? Pharma By Ike Swetlitz Jan. 11, 2017 Reprints Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED State Medicaid programs and big insurer drop EpiPens in favor of generics 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. 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. GET STARTED Mylan
Biotech Amgen wants you to know that it’s not losing faith in its next big drug Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED What’s included? Log In | Learn More National Biotech Reporter Damian covers biotech, is a co-writer of The Readout newsletter, and a co-host of “The Readout LOUD” podcast. About the Author Reprints By Damian Garde May 3, 2017 Reprints @damiangarde 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. Ric Francis/AP Damian Garde GET STARTED What is it? [email protected] Preventing migraines is biopharma’s next multibillion-dollar opportunity, according to Amgen, which is leading a gaggle of drug makers racing to the market. But if warding off headaches is such a lucrative opportunity, why is Amgen suddenly giving up some of the spoils of its in-development therapy?That’s the question buzzing around Wall Street circles after Amgen’s recent deal with Novartis, in which it promised the Swiss giant a cut of US sales of its migraine drug in exchange for help with the costs of development and marketing. The drug, which reduces monthly migraines by targeting a protein called CGRP, is widely expected to bring in blockbuster sales once it’s approved next year, making Amgen’s move seem incongruous to analysts. 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 drug developmentneurologySTAT+
Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED 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. Pharma Win McNamee/Getty Images 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. Log In | Learn More ‘Doctors are gullible’: Former FDA chief takes aim at drug ads, prices & supplements GET STARTED What is it? What’s included? BOSTON — America wastes a lot of money on useless health care, and doesn’t have enough data on what is really useful, said Dr. Robert Califf, former commissioner of the Food and Drug Administration, at a conference on Wednesday.“We know that so much of what we do is practically worthless, and the incentives for payment right now often reinforce things that don’t have much value,” Califf told a crowd of hundreds at the World Medical Innovation Forum, a conference hosted by Partners Healthcare. “[But] there weren’t many therapies that were evaluated adequately to actually calculate value.” By Ike Swetlitz May 3, 2017 Reprints Tags STAT+
Small, low-quality biotechs burdened with weak pipelines will often design and analyze clinical trials in a way that almost guarantees executives the ability to claim victory, even if the preponderance of the data produced say otherwise.This is the dubious feat accomplished by ResTORbio (TORC) on Wednesday with a mid-stage clinical trial of a drug for respiratory tract infections. What is it? [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. ResTORbio drug study results weaken under scrutiny Tags biotechdrug developmentSTAT+ Adam’s Take 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. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED By Adam Feuerstein July 25, 2018 Reprints GET STARTED About the Author Reprints What’s included? @adamfeuerstein Adam Feuerstein Log In | Learn More Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.