Pharmalot, Pharmalittle: Rising drug prices cost workers’ compensation programs

first_img [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.advertisementcenter_img 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.last_img read more

Most antidepressants don’t work on kids and teens, study finds

first_img Related: Privacy Policy Related: Please enter a valid email address. “No one should be on any other antidepressant, and I think it’s doubtful that people should be on Prozac, as well,” said Dr. Jon Jureidini, a child psychiatrist at the Robinson Research Institute at the University of Adelaide in Australia, who wrote a commentary that ran with the study. “The case for Prozac is quite weak.”Prozac was found to significantly benefit children and teens with major depression, though the magnitude of benefit ranged from almost nothing to a dramatic improvement.advertisement @kweintraub Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Karen Weintraub The vast majority of antidepressants given to kids and teens are ineffective and potentially dangerous, according to a new study in The Lancet.Of 14 regularly prescribed drugs, only one — Prozac — proved effective enough to justify giving to children and teens, the researchers found.If medications are given at all, Prozac should be the drug of choice, the study concluded.advertisement Sixty-five percent of the studies were sponsored by pharmaceutical companies, but Cipriani said he was able to use statistical manipulations to reduce any company bias.“I think our data are quite robust. However, we cannot rule out the possibility of sponsorship bias,” said Cipriani, who has earned fees as an expert witness for a generic drug manufacturer that makes some antidepressants. Only one of the paper’s 19 authors reported receiving personal and grant funding from large pharmaceutical companies.More research is needed on the causes of depression in children and teens and on the longterm use of antidepressants, Cipriani said.“The message is, medication should not be an easy answer to the problem of major depression,” Cipriani said, “But at the same time, we have a tool which is effective, so if needed, let’s use it.” Tags antidepressantsdepressionteenagerscenter_img This antidepressant may be no better than cheaper alternatives. But demand could soon soar By Karen Weintraub June 8, 2016 Reprints Depression screening for adults and adolescents has benefits, but don’t ignore the downsides Matt Dtrich/The Indianapolis Star/AP Karen Weintraub is an independenthealth/sciencejournalist, journalism teacher, and bookauthor. HealthMost antidepressants don’t work on kids and teens, study finds Leave this field empty if you’re human: Several doctors warned that patients shouldn’t stop taking their medications because of this study. Abruptly stopping medication can cause problems, including suicidal thinking. And some individuals might still benefit from the other drugs, Cipriani said.“If the patient’s responding to one treatment, they have to keep the treatment, of course. But on average, if I have to start a treatment, probably the best one is fluoxetine [Prozac] and not the others,” Cipriani said.Medication as the only optionThe new paper, a so-called meta-analysis, looked at 34 previously conducted studies. Those studies included more than 5,200 children and teens who took one of 14 antidepressants or a placebo an average of 8 weeks. The study did not consider long-term use of the drugs because there hasn’t been enough previous research to analyze, Cipriani said.Although several of the studies claimed to include patients as young as 6, Cipriani said there was virtually no data on children younger than 9.Dr. Carl Bell, a community psychiatrist and clinical professor emeritus at the University of Illinois at Chicago, said that until recently, he doesn’t remember seeing children younger than 13 who were suicidal or severely depressed. “I don’t know what happened, but now I see it all the time,” he said.In his experience, antidepressants work well on his preteen and adolescent patients.Bell said he would be happy to refer his inner-city patients to social services and therapy, but they’re “pretty much nonexistent” in the communities he serves. “That only leaves one choice,” he said: medications.Questioning methodsOthers raised concerns about the methods used to conduct the study.Prozac looked the best merely because it has been the subject of the most research, said Dr. Maurizio Fava, a psychiatric researcher at Massachusetts General Hospital in Boston.“I think the conclusion is a conclusion that is biased,” he said.Many of the other drugs would have been seen as effective if the study’s authors had properly considered the impact of placebos, he said. Because of the powerful placebo effect in treating depression, only a small number of participants in each of the 34 studies would have shown a benefit beyond the placebo. Only a large study, or multiple studies considering the same drug — as was available for Prozac — would show a benefit, Fava said. Other drugs the researchers analyzed — including Zoloft, Paxil, Celexa, and Cymbalta — showed no benefit over placebo for this age group.About 3 percent of children under 12, and 6 percent of teens worldwide are believed to have depression. It’s not clear how many of them are on medication.Forms of talk therapy, including cognitive behavioral therapy, have been shown to be effective against depression in young people, and regular exercise and adequate sleep can also make a difference, Jureidini said. The vast majority of children do not need to be medicated for their depression, he said, but many are.“What we’re up against is the marketing enterprise of the pharmaceutical industry combined with wishful thinking on the part of doctors and parents that there might be a good, simple solution for adolescent distress,” he said. “It’s something we need to take very seriously, but we don’t need to make it into a medical condition when it most times isn’t.”A different kind of depressionQuestions have been raised before about the usefulness of antidepressants in young people whose brains are still developing. More than a decade ago, the Food and Drug Administration added a black-box warning to a number of antidepressants used by teenagers, saying that they might increase suicidal thinking.In older people, antidepressants like Prozac are believed to trigger the growth of new brain cells and new connections among them, but there is no obvious biological benefit to the developing brains of children and adolescents.Depression also looks different in young people, often showing up as aggressive behavior, irritability or poor school performance, rather than an obviously depressed mood, said Dr. Andrea Cipriani, the University of Oxford psychiatrist who led the new study. About the Author Reprintslast_img read more

If you get sick at the Olympics, don’t expect a private hospital room

first_img 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.center_img 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.last_img read more

The aging of the population with Down syndrome is a positive sign

first_imgFirst OpinionThe aging of the population with Down syndrome is a positive sign Previous work by others estimated that 250,700 people with Down syndrome were living in the United States as of 2008. Our estimate, published earlier this year in the journal Genetics in Medicine, was considerably lower: 206,366 people living with Down syndrome as of 2010. That included individuals born outside the US but now living here. We used a more precise accounting for selective abortions and for long-term survival rates for children born with Down syndrome, which both influence the size of the population. Estimates of percentage of people with Down syndrome by age in the US, 1950–2010≥6050–5940–4930–3925–2920–2415–1910–145–90–41950195519601965197019751980198519901995200020052010020406080100YearDown syndrome by age group* (%)0–45–910–1415–1920–2425–2930–3940–4950–59≥60195030.619.713108.66.87.52.61.20.1195528.62014.39.87.56.48.63.21.20.2196026.319.51511.17.65.88.94.21.20.319652219.215.512.296.18.75.21.60.3197016.317.516.313.410.57.79.362.40.4197512.413.815.614.7129.411.76.53.20.6198011.410.812.514.213.310.914.87.33.90.9198511.89.99.811.312.81217.69.24.21.3199012.610.48.98.810.211.519.711.64.81.5199511.911.49.68.189.220.313.86.11.7200011.610.910.68.87.47.31815.77.72200512.310.610.19.88.16.814.416.39.22.5201012.311.49.99.397.412.414.510.63.10–4 My sister, Kristin, and I grew up splashing together in swimming pools, delighting in ice cream cones, and singing along to movie musicals. We were very much alike, with what we saw as a small difference: She was born with Down syndrome and I wasn’t.We’ve grown together into the people we are today, learning from each other and supporting one another. Kristin has become the checks and balances of my personal and professional lives. Whenever I am frustrated or tired by life’s hassles, Kristin’s can-do spirit reminds me that my struggles will not only be OK, but they will be worth it.Kristin, now age 36, has inspired my life’s work — caring for individuals born with Down syndrome, working with their families, and furthering our community’s understanding of this genetic condition.advertisement Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. Brian G. Skotko By Brian G. Skotko Jan. 4, 2017 Reprints Ben Majewski (right), pictured with mentor Janene Davis, is a resource specialist in the Mass General Down Syndrome Program. Massachusetts General Hospital Privacy Policy That understanding begins with better knowing the size of the Down syndrome population. Nearly every book, webpage, and research article about Down syndrome starts with information about the number of people living with it. But those estimates have been quite inaccurate.Working with Gert de Graaf of the Dutch Down Syndrome Foundation and Frank Buckley of Down Syndrome Education International/USA, we stitched together expansive databases spanning six decades to create what we believe are more accurate estimates of the number of people living with Down syndrome.advertisement Tags geneticspatients Please enter a valid email address. About the Author Reprints Talia Bronshtein/STAT *Includes foreign-born people with Down syndrome who immigrated to the US. | Source: Genetics in Medicine In a study published last year in the American Journal of Medical Genetics Part A, we observed that in recent years 30 percent fewer babies have been born with Down syndrome than there would have been if elective terminations were not available. In the US, almost three-quarters of expectant parents who learn prenatally that their child has Down syndrome choose to terminate the pregnancy. We estimated that about 3,100 fetuses with Down syndrome are terminated each year. That translates into 19 percent fewer people living with Down syndrome in the US as of 2010.Babies born today with Down syndrome and their families can expect a lifetime of possibilities and potentials. The life expectancy for people with Down syndrome continues to rise — the median lifespan is now 58 years. Heart conditions, which can accompany Down syndrome, have been routinely and easily corrected by surgery since the early 1980s. Medications can solve co-occurring thyroid problems, and sleep apnea can be stamped out with good surveillance and treatment options.These and other advances in caring for individuals with Down syndrome make it possible for people like Ben Majewski to lead thriving and healthy lives.Ben is a well-known fixture for his role as a resource specialist in the Mass General Down Syndrome Program, which I co-direct. In between greeting and escorting patients from the waiting room to the exam room and monitoring the daily clinic schedule, Ben shares his experience as an individual with Down syndrome. Celiac disease is a common concern among patients and their parents, according to Ben, who is armed with his own background in managing that condition and an iPad full of reference material and presentations that he developed. @brianskotko Leave this field empty if you’re human: At 26, Ben has a lifetime of personal knowledge to share. But he’s also a snapshot into the future for families. In addition to his work at Mass General, Ben is also employed through the Boston Red Sox and by an Irish restaurant in Newton, Mass. He’s spoken in front of the United Nations on Down Syndrome Day. He lives independently from his family and dreams of getting married someday. In essence, he’s like anyone else.But Ben knows there are challenges ahead, just as I know from my clinical experience that not all people with Down syndrome are alike. Adults with Down syndrome often develop medical conditions like obstructive sleep apnea and Alzheimer’s disease. Some can live independently, others need more assistance. Programs like ours provide multidisciplinary approaches to these medical and psychosocial issues to help our patients maximize their life potential. Culturally appropriate guidance is also essential to help individuals with Down syndrome with everything from feeding techniques to step-by-step transition planning and the challenges of safely riding a public transit system as confusing as Boston’s.The most valuable resource that programs like ours have for improving the lives of people with Down syndrome are individuals like Ben and Kristin. No one can completely attest to a life with Down syndrome unless they are actually experiencing it. Ben and Kristin demonstrate each day that, with support, people with Down syndrome can lead healthy, happy lives.Brian G. Skotko, MD, is co-director of the Mass General Down Syndrome Program and assistant professor of pediatrics at Harvard Medical School.Disclosures: Dr. Skotko occasionally consults on the topic of Down syndrome through the Gerson Lehrman Group. He receives remuneration from Down syndrome nonprofit organizations for speaking engagements and associated travel expenses. Skotko receives annual royalties from Woodbine House Inc. for the publication of his book, “Fasten Your Seatbelt: A Crash Course on Down Syndrome for Brothers and Sisters.” Within the past two years, he has received research funding from F. Hoffmann-La Roche Inc. and Transition Therapeutics to conduct clinical trials on study drugs for people with Down syndrome. Skotko is occasionally asked to serve as an expert witness for legal cases in which Down syndrome is discussed. He serves in a non-paid capacity on the Honorary Board of Directors for the Massachusetts Down Syndrome Congress, the Board of Directors for the Band of Angels Foundation, and the Professional Advisory Committee for the National Center for Prenatal and Postnatal Down Syndrome Resources. [email protected] last_img read more

State Medicaid programs and big insurer drop EpiPens in favor of generics

first_img 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 Mylanlast_img read more

Amgen wants you to know that it’s not losing faith in its next big drug

first_imgBiotech 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.center_img 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+last_img read more

‘Doctors are gullible’: Former FDA chief takes aim at drug ads, prices & supplements

first_img 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+last_img read more

A doctor without health insurance? What could go wrong?

first_img @jkwillettmd Related: An outrageous hospital charge: I paid $710 for an hour of babysitting Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson Newsletters Sign up for First Opinion A weekly digest of our opinion column, with insight from industry experts. You’re probably wondering why I didn’t simply see a doctor. I’m a bit reluctant to admit it, but I didn’t have health insurance. That’s right — I was a doctor without health insurance. Leave this field empty if you’re human: Later, hospital bill in hand, the explanation became easier.The bill for my emergency department visit totaled $10,282.34. I had asked that intravenous medications be changed to oral medications when possible because they are less expensive, and refused some additional tests and medications. This kind of insider information, which most people don’t have, helped me keep costs to a minimum — though I was shocked to see a $10,000 bill.The author’s bill for emergency treatment of pneumonia. Courtesy Jessica K. WillettConsider a single-income family in the U.S. I pick that category because about 1 in 4 children in our country are currently being raised by a single parent, and that number is rising. The average median income for a single-income family is about $35,000. If that parent or caregiver gets sick and needs medical care, how will she or he pay a bill that could be one-third or more of the family’s total annual income? That’s a powerful reason to wait. Earlier in the fall, in the transition from one job to the next, my insurance had lapsed. When I was prompted to sign up for insurance with my new employer, I was told that it wouldn’t go into effect until open enrollment on Jan. 1. I didn’t question that. I was healthy. A few months without insurance would be fine.advertisement A colleague suggested I get covered under what’s commonly called COBRA. But I was flabbergasted by the cost, especially on top of student loan payments and living expenses. I then looked at Covered California, my state’s exchange for Affordable Care Act insurance plans, and was equally dismayed. Knowing my almost pristine health history, I opted to forgo insurance and instead pay the individual mandate penalty, which was a fraction of the cost of coverage.In other words, here I was talking myself out of going to the doctor — even though I was starting to lean in that direction — because I knew that a hospital bill without insurance would be more than I could handle.I’m not an anomaly. Many Americans do this every day.You can probably guess how my story unfolded. When I finally couldn’t put it off any longer, and was barely able to get out of bed, I ended up in the emergency department I work in. A colleague, looking at my chest X-ray showing extensive pneumonia, asked why I waited so long to see a doctor. In tears, I tried to explain. Privacy Policy First OpinionA doctor without health insurance? What could go wrong? center_img Please enter a valid email address. About the Author Reprints Trending Now: Tags insurancepatientsphysicians “It’s probably nothing.” That’s what I said to myself not long ago when I started feeling lousy. I should know, since I’m a physician. But I learned the hard way that those “nothings” can get serious fast — and without health insurance, the bill can be astronomical.Just after Thanksgiving last year, it occurred to me that I was more tired than usual. I chalked it up to working a long string of shifts in the emergency department at the hospital. “I never get sick!” I told myself, and upped my caffeine intake.About a week later, I started spiking fevers, and my appetite dwindled. Something was wrong but I couldn’t put my finger on it. I convinced myself it was just a virus and would pass with time and rest. But I felt worse over the following week, not better. I continued to convince myself that it, whatever “it” was, would fade away on its own. I thought of the cost of a doctor’s visit, blood tests, imaging, and the rest, then took another Tylenol and went back to bed.advertisement By Jessica K. Willett March 7, 2018 Reprints Jessica K. Willett We talk about improving access to health care through health literacy, education, and outreach. These things matter. But until we address the cost of health care, a huge barrier to care will remain. Medicine is tightly intertwined with social factors, which affect both physicians and patients — and sometimes, both at the same time.My story isn’t unique. I now have health insurance, which is a relief to me if similar circumstances arise in the future. Yet I know that many of my patients — and perhaps many of my colleagues — aren’t so lucky. Although I was previously aware of the many social circumstances affecting my patients’ access to care and the circumstances contributing to their overall health, I’m now able to relate to it on a more personal level. Now when I ask the question, “Why did you wait so long to see a doctor?” I can also say, “Yes, I absolutely understand why.”Jessica K. Willett, M.D., is an emergency physician who works in Northern California. Adobelast_img read more

ResTORbio drug study results weaken under scrutiny

first_img 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.last_img read more

The coronavirus outbreak has left medical supplies in short supply. Is the nation’s emergency stockpile ready to help?

first_imgHealthThe coronavirus outbreak has left medical supplies in short supply. Is the nation’s emergency stockpile ready to help? By Lev Facher March 10, 2020 Reprints Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson WASHINGTON — The U.S. government has a secretive, $7 billion stash of emergency medical equipment — one that it drew on to respond to the terror attacks of 9/11, to prepare for a subsequent threat of anthrax attacks in 2001, and to help thousands of homes guard against Zika with insecticide.The outbreak of the novel coronavirus, however, marks the first potential pandemic to reach U.S. soil since the H1N1 flu of 2009, teeing up one of the biggest challenges yet for the 21-year-old store, known as the Strategic National Stockpile.Already, the outbreak has placed significant strain on the stores of masks, medicine, and medical equipment. The stockpile has been called on to help with efforts to repatriate and quarantine Americans flown back from China and Japan, but has come under fire for a perceived shortage of masks — and for allowing millions of masks already in its stock to pass their expiration dates.advertisement @levfacher [email protected] N-95 face masks EVA HAMBACH/AFP via Getty Images Please enter a valid email address. Pandemic-preparedness experts and former public health officials sing the stockpile’s praises. Tommy Thompson, the former Wisconsin governor and health secretary during the George W. Bush administration, recalled relying on the SNS in the hours following the Sept. 11 terrorist attacks.“When 9/11 happened, we were able to get a plane in the air from CDC to deliver 50 tons of medical supplies up to the city of New York by 5 o’clock the day of 9/11,” he said. “And then we were able to get 100,000 masks delivered out of our stockpile to the city of New York that same evening, and gloves the next day — 200,000 pairs.”During Thompson’s tenure, he recalled, he pushed to increase the number of stockpile warehouse locations from eight to the current 12 — an effort, he said, to ensure the network was up to the task of quickly supplying locations across the 50 states and U.S. territories with emergency medical supplies on hours’ notice.“They have gloves, they have masks, they have medicines, they have scales to weigh ingredients,” Thompson said. “They have a full supply of things to fight infectious diseases and viruses like we’re experiencing now.”Adams, the acting director, also emphasized the SNS’ readiness. Should the current crisis worsen, he said, the stockpile stands ready with supplies of oral and intravenous antibiotics and other medical equipment that could prove useful. But beyond surgical masks and respirators, hospitals and local health departments haven’t yet found those items in short supply.“That’s something that we are in a position to provide support for around our pandemic influenza planning and other disaster planning,” Adams said. “But that’s not been an area of need.” Newsletters Sign up for D.C. Diagnosis An insider’s guide to the politics and policies of health care. Support STAT: If you value our coronavirus coverage, please consider making a one-time contribution to support our journalism. Still, public health officials have criticized the stockpile for, in some cases, failing to act with sufficient urgency. After officials in Washington state requested 233,000 respirator masks, the stockpile initially offered to supply less than half amount, the Washington Post reported. An SNS spokeswoman said the state eventually received the full requested shipment.And the store has already proven valuable in other areas, Adams said. Beyond sending masks to hard-hit states, the stockpile helped with efforts to bring Americans in China and Japan back to the U.S., supplying protective equipment for medical workers who monitored the Americans’ health during their stays on military bases. That effort largely relied on materials stored in SNS warehouses but maintained by the National Disaster Medical System, a separate emergency medical-supply distribution network.“We were quite involved with moving matériel to support the repatriation of State Department [employees] and other Americans from China, and then a follow-on mission of doing so from Japan,” Adams said.Adams added that the stockpile has since “transitioned into providing support to what some would call ‘hot spot areas,’ states where they’re actively managing large numbers of patients with COVID-19,” the respiratory disease caused by the coronavirus, namely by shipping respirator masks to hard-hit regions like the Seattle metropolitan area. Trending Now: In an interview, the stockpile’s acting director Steven Adams reiterated that the SNS stocks roughly 13 million N95 masks — though health secretary Alex Azar has told lawmakers that as many as 5 million may be expired.Adams said the federal government updated guidelines on March 1 clarifying that many older masks were still usable. All supplies in the current SNS store, a spokeswoman said, are in good working order. Adams also emphasized that the federal government had recently pledged to purchase 500 million more masks, though the order won’t be fulfilled for 18 months.advertisement Washington Correspondent Lev Facher covers the politics of health and life sciences. Privacy Policy Lev Facher About the Author Reprints Leave this field empty if you’re human: The coronavirus outbreak comes at a time of significant change for the stockpile. Its longtime director, Greg Burel, retired at the end of January, according to an agency spokeswoman. Adams, the deputy director, was left at the helm in an acting capacity.And in 2018, the Trump administration shifted control of the stockpile from the Centers for Disease Control and Prevention to an office within the Department of Health and Human Services dedicated to emergency preparedness and response.While public health advocates have criticized the Trump administration for proposing cuts to the CDC budget and for firing a National Security Council staffer overseeing global pandemic response, few opposed shifting control of the stockpile from CDC to its parent agency, HHS.Irwin Redlener, a Columbia University public health professor, said it makes more sense to house the stockpile under the Office of the Assistant Secretary for Planning and Response, which oversees emergency preparedness efforts.“I actually think it’s been good to have it over at ASPR,” he said.The stockpile was established in 1999 with the goal of guarding against both pandemics and threats of bioterrorism, including substances like anthrax and botulism. With roughly 200 employees, the SNS maintains 12 sites across the country, but keeps their location classified, citing security concerns.While the locations are secret, much of the warehouse’s inventory is public: Recent SNS contracts include a $1.5 billion deal to restock its shelves with smallpox vaccine, and a number of other nine-figure contracts for expensive pharmaceuticals that health officials hope they’ll never need. Tags Coronavirusglobal healthgovernment agenciespolicyWhite Houselast_img read more