Pharmalot, Pharmalittle: Sale of cancer treatment halted, Ebola vaccine deal signed

first_imgPharmalotPharmalot, Pharmalittle: Sale of cancer treatment halted, Ebola vaccine deal signed Martin Shkreli is seeking for new lawyers in his quest to beat securities fraud charges, according to Bloomberg News, which cited a court filing.Zafgen says that its obesity drug candidate met both main goals in a late-stage trial, which gained notoriety last year after two patient died, Xconomy tells us.Pfizer is expected to reach a joint production deal later this month with Polysan, which is based in St. Petersburg, Russia, according to TASS.The FDA approved two additional indications for the Cosentyx medicine from Novartis for treating ankylosing spondylitis and psoriatic arthritis, Modern Medicine says.Lilly and Incyte are seeking FDA approval for their experimental JAK inhibitor, called baricitinib, to treat moderately to severely active rheumatoid arthritis, Pharma Times writes.The FDA has begun a priority review of an Eisai treatment for the most common form of kidney cancer, according to PMLive.Pfizer invested $46 million in separate collaborations with four R&D companies that specialize in developing gene therapies and immuno-oncology candidates, among other things, Outsourcing Pharma tells us. By Ed Silverman Jan. 20, 2016 Reprints Top of the morning to you. And a fine one, it is, although a bit nippy here on the Pharmalot campus, where a warm sun is shining, the shortest of short people has left for the local schoolhouse, and the official mascots are happily snoozing. As for us, we are keeping toasty by quaffing cups of delicious stimulation. As always, we invite you to join us. Remember, no prescription is required. And now, time to get on with things. Here are a few items of interest to help you along. Hope your day is successful and do keep us in mind when you hear something interesting …Two Indian states halted sales of the Avastin cancer treatment, which some doctors also use off-label to treat macular degeneration, after the treatment hampered the vision of 15 patients, Reuters reports. Studies have shown Avastin, which is made by Roche, can help with the eye affliction. But the drug maker has repeatedly warned about the risk of contamination, since vials of the cancer treatment must be divided for eye patients.The New York attorney general reached a deal with Amphastar Pharmaceuticals to extend a $6 price cut on naloxone, which can reverse an opioid or heroin overdose. The drug maker was widely criticized over the past two years by state officials and members of Congress for its pricing. Last summer, Representative Elijah Cummings, a Democrat from Maryland, said state agencies were paying $41 a dose, a 111 percent increase from June 2014.advertisement About the Author Reprints The Gavi global alliance for vaccines, a public-private partnership, signed a $5 million deal committing to purchase a vaccine that Merck is developing to protect against future outbreaks of the deadly Ebola virus, Reuters writes. In doing so, the organization believes the arrangement will help the drug maker take the vaccine through late-stage clinical trials. As part of the arrangement, Merck is expected to seek licensing by the end of 2017.French Health Minister Marisol Touraine criticized the slow response of the contract research organization running the clinical trial in which one patient died and others are in critical condition, PharmaFile writes. She noted that BioTrial did not report that the patient with the worst side effects was taken to a hospital for four days. “Faced with such a serious situation, we would expect the laboratory to approach the health authorities more quickly,” she said.advertisement Ed Silvermancenter_img [email protected] @Pharmalot Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Alex Hogan/STAT Tags AvastinEbolaMartin Shkrelilast_img read more

Pharmalot, Pharmalittle: Sanofi poaches a top scientist from AstraZeneca

first_img By Ed Silverman March 29, 2016 Reprints @Pharmalot Drug makers told an Indian court that a government’s decision to ban 344 fixed-drug combinations was made without considering any clinical data, The Economic Times tells us.A federal appeals court upheld a verdict in favor of Pfizer against a man who claimed he developed a potentially fatal lung condition from Pondimin, once one-half of the “fen-phen” diet treatment, Reuters reports.Natco Pharma stock nosedived after the company received 483 observations from the US Food and Drug Administration concerning two facilities in India, The Economic Times writes.Advanced BioHealing executive Todd Clawson pleaded guilty last week to a charges of paying kickbacks to Veterans Affairs doctors for promoting a company product, The Seattle Post-Intelligencer informs us.Chase Pharmaceuticals, which recently hired former Allergan president Doug Ingram as its chief executive, has raised $12 million in a new equity round, MedCity News says. A study published Monday showed that Theranos’s results for total cholesterol were lower by an average of 9.3 percent than those from Quest and LabCorp, the two largest labs in the US, and could alter medical decisions made by physicians, The Wall Street Journal reports. Doctors use these lab tests to help determine when to prescribe statins, which are used to lower cholesterol.Novo Nordisk broke ground Monday on a new $1.8 billion manufacturing facility in Clayton, N.C., which is forecast to add nearly 700 jobs to the area, The Triangle Business Journal writes.advertisement Alex Hogan/STAT Good morning, everyone, and how are you today? A bright, shiny sun is illuminating the windswept Pharmalot campus, where the short person has left for the local schoolhouse and Mrs. Pharmalot is off to a new endeavor. As for us, we are engrossed in the usual routine of sniffing around for interesting items. A few tidbits, meanwhile, appear below. Time to hoist our cup of stimulation in celebration of another eventful day. Hope yours goes well …Sanofi hired a leading AstraZeneca scientist, Yong-Jun Liu, as its new research head, the second high-profile researcher to leave the drug maker in the past year. Liu, who is a specialist in immunology, currently heads the MedImmune biotech unit at AstraZeneca, where he has worked since 2014. At Sanofi, which is undergoing a reorganization, he will head research and report to Elias Zerhouni, who oversees global R&D.Doctors in New York are now required to send prescriptions to pharmacies electronically instead of handing patients a handwritten prescription slip, CBS News reports. The move is intended to combat the ongoing abuse and misuse of opioid painkillers. About 60 percent of prescriptions are now sent electronically, although the trend is still largely voluntary.advertisement About the Author Reprintscenter_img Ed Silverman Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. [email protected] PharmalotPharmalot, Pharmalittle: Sanofi poaches a top scientist from AstraZeneca Tags opioidsSanofiTheranoslast_img read more

Spike in a food-borne illness in Texas baffles health officials

first_img Produce from Mexico may be one cause for the high rate of cyclosporiasis in Texas, officials say. Nick Wagner/AP Privacy Policy Associated Press Please enter a valid email address. Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. Chipotle, E. coli, and more: The surprising truths about food-borne illnesses DALLAS — Health officials are trying to determine why there’s been a dramatic increase in the number of people in Texas each year who contract a food-borne illness that’s often linked to produce imported from Mexico and other warmer climes.Although there have been outbreaks in several states in recent years, including one in 2005 in Florida that sickened nearly 600 people, cyclosporiasis infection rates returned to normal levels after the sources were contained.But in Texas, the number of cases shot up from 44 in 2012 to 351 in 2013 and has remained in the triple digits ever since, with 200 in 2014, more than 300 last year, and more than 100 so far this year, according to the Texas Department of State Health Services.advertisement She said there are other circumstances that could be driving up the number of cases, such as the outbreaks raising more awareness of the disease, leading to additional testing for it, and more diagnoses. And given its long border with Mexico, Texas could be consuming more imported produce than other states, raising the risk of infection, Mann speculated.There are more than 250 different food-borne diseases, but cyclosporiasis is among the most common that are closely tracked by health agencies. It often spreads when human feces contaminated with the cyclospora parasite come into contact with water or produce. Those sickened can suffer from diarrhea, cramps, fatigue, and vomiting. The Food and Drug Administration last year banned imports of some fresh cilantro from Mexico after an investigation found feces and toilet paper in growing fields there.The cilantro, imported from the Mexican state of Puebla, was linked to 2013 and 2014 outbreaks of stomach illnesses in the US, and health authorities also suspected cilantro from the region was responsible for additional cases in Texas and Wisconsin last year.No other state in recent years is seeing as many cases as Texas. Florida had its 2005 outbreak, which was linked to basil from Peru, but it typically gets a few dozen cases per year. California recorded about two-dozen cases, total, in the past four years, and Arizona has had just five since the start of 2015.Seattle attorney Bill Marler, who represents people sickened by contaminated foods, said the boom in Texas cyclosporiasis cases is unusual because the parasite isn’t commonly found there. Related: By Associated Press Sept. 1, 2016 Reprints HealthSpike in a food-borne illness in Texas baffles health officials Leave this field empty if you’re human: “As we’ve been importing more food from places like Mexico, Honduras, and Guatemala where cyclospora is endemic, we’re starting to see more cases in the United States,” said Marler, who built his national reputation representing victims of a 1993 E. coli outbreak at Seattle Jack in the Box restaurants.The federal government estimates that about 52 percent of fresh fruit and 22 percent of fresh vegetables are imported. Food safety advocates question whether regulations in other countries are adequate to protect US consumers and whether US regulators are equipped to deal with the influx.“There’s a widespread concern that the FDA is getting overwhelmed by all the imported food coming in,” said Thomas Gremillion, director of food policy at the Consumer Federation of America.The federal Centers for Disease Control and Prevention found that aside from E. coli infections, there were no significant changes in food-borne infection rates last year compared to the three previous years. But Gremillion said the “status quo is pretty grim,” citing CDC statistics showing that approximately 48 million Americans are sickened by food-borne illnesses each year and 3,000 die.The FDA in November released rules that will require importers to be more accountable for the safety of food they bring into the US market. For instance, certified inspectors will conduct food-safety audits on foreign food processors.— David Warren About the Author Reprints Tags epidemicfood poisoningfood-borne illness State and federal health officials say an increasing amount of produce that’s imported from tropical and subtropical regions — where the parasite that causes the illness is endemic — is likely contributing to the recent outbreaks. Some in the past few years were traced to tainted produce from Mexico, but officials haven’t found a common source for this year’s cases in Texas, said Christine Mann, a spokeswoman for the Texas Department of State Health Services.“It’s very challenging for epidemiologists to investigate food-borne outbreaks,” Mann said, explaining that investigators must consider myriad factors like the travel itinerary of people who become ill.advertisementlast_img read more

What to look for when picking where to give birth? Not what you may think

first_img“Pay attention to the journey from where they check in, to the triage area, to the labor room,” he said. “Look at how the labor floor is laid out. Does it feel organized or is it cluttered? Where do the doctors and nurses work when they’re not in the room? Are these workstations close by or are there some rooms that look far away?”“I would not advocate excluding a hospital simply because of the way it looks, but I think paying attention to the design may provoke questions that help you understand what your experience may be like.”Hospital administrators, Shah said, often overlook these factors too.“It is critical for health care administrators to involve clinicians in the design process to make sure the built environment supports rather than hinders their work,” he said. “It is surprisingly common for health care facilities to be designed with minimal input from the end-users.” When expectant parents tour prospective hospitals and birthing centers, they may be focusing on the wrong things: a comfortable sitting room for family or special perks.But the design of those facilities, often overlooked by prospective parents, could be what really affects the birth experience, and even increase a woman’s likelihood of having a caesarean section, according to recently published research.When gauging hospitals and birthing centers, many prospective parents dwell excessively on amenities in the delivery rooms, said the report’s author, Dr. Neel Shah, an OB/GYN at Beth Israel Deaconess Medical Center in Boston. But there are “multiple ways that what is happening outside your room can end up impacting the care you receive.”advertisement C-section stats seem not to matter to women when choosing where to give birth By Bob Tedeschi April 11, 2017 Reprints Philippe Huguen/AFP/Getty Images Among them: Please enter a valid email address. Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine.center_img Distance between labor delivery rooms. Of the 12 childbirth facilities studied, maximum distance between delivery rooms ranged from 9 feet to 242 feet. Those with the shortest distance between rooms were among those with the lowest C-section rates. Why? In part because, even though more privacy might be nice for patients, more distance increases the staff’s travel time.Number of deliveries per room. If a facility has a relatively small number of rooms but a high number of deliveries, staff may need to move mothers through more quickly, thereby possibly increasing the likelihood of a C-section. Birth centers often seek to maintain a threshold of around 100 deliveries per room per year. At one looked at as part of the study it was 479.Distance between the nursing station and patient rooms. Such stations often host monitoring equipment for fetal heart rates and a mother’s vital signs, and stretching the distance between the station and patient rooms could burden the medical staff and ultimately increase C-section rates. (Average distances in the facilities studied varied widely, from 23 feet to 114 feet.) Leave this field empty if you’re human: Expectant parents should widen their focus when they tour, said Shah, who works in Ariadne Labs, the research group led by Dr. Atul Gawande.advertisement HealthWhat to look for when picking where to give birth? Not what you may think Privacy Policy Related: Tags hospitalswomen’s healthlast_img read more

This orthopedic surgery is the world’s most common. But patients rarely benefit, a panel says

first_img This orthopedic surgery is the world’s most common. But patients rarely benefit, a panel says Hospitals Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED By Casey Ross May 10, 2017 Reprints Christopher Furlong/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. Casey Ross What is it? 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] center_img @caseymross What’s included? 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 GET STARTED Log In | Learn More The world’s most common orthopedic procedure — knee arthroscopy — is frequently a waste of time and money and should almost never be performed on patients with degenerative knee disease.That’s the conclusion of an international panel that strongly recommends against arthroscopic surgery in a new guideline published by the BMJ. The panel found that, while performed 2 million times per year worldwide, knee arthroscopy offers minimal benefits to patients with degenerative knee disease, which affects about 25 percent of people older than 50. Tags hospitalsorthopedicsphysicianslast_img read more

Governors association plans a big strategy session over drug pricing

first_img Ed Silverman With prescription drug prices continuing to strain state budgets, the National Governors Association is planning a meeting later this year to explore strategies for lowering costs, notably for hepatitis C drugs. And payers and drug makers will be invited, according to one state official familiar with the plan.Details have not been disclosed, but the effort reflects ongoing concern that some medicines remain out of reach for people who rely on cash-strapped state Medicaid programs, according to Dr. Rebekah Gee, the Louisiana Department of Health secretary, who has been involved in the planning. Joe Raedle/Getty Images Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Governors association plans a big strategy session over drug pricing [email protected] Tags drug pricingpharmaceuticalsSTAT+states What is it? By Ed Silverman Sept. 25, 2017 Reprints GET STARTEDcenter_img About the Author Reprints 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. 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. Log In | Learn More @Pharmalot What’s included? Pharmalot last_img read more

Is the Novartis breakthrough gene therapy overpriced or not?

first_img Late last year, Novartis (NVS) began marketing a breakthrough gene therapy for treating youngsters with advanced leukemia and slapped a $475,000 price tag on the one-time treatment. The eye-popping number sparked debate, but the drug was quickly deemed cost effective by a nonprofit watchdog.The controversy is far from over, though. 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. Ed Silverman By Ed Silverman Feb. 9, 2018 Reprints What is it? [email protected] Pharmalot Log In | Learn More Is the Novartis breakthrough gene therapy overpriced or not? What’s included?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. Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Georgios Kefalas/Keystone/AP Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED @Pharmalot GET STARTED Tags cancerdrug pricingpharmaceuticalsSTAT+ About the Author Reprintslast_img read more

Pharmalittle: Compounders getting pushback; fast-acting flu drug shows potential

first_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. GET STARTED Pharmalittle: Compounders getting pushback; fast-acting flu drug shows potential General Assignment Reporter Liz focuses on cancer, biomedical engineering, and how patients feel the effects of Covid-19. What is it? Log In | Learn More What’s included? Unlock this article by subscribing to STAT+ and enjoy your 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. Alex Hogan/STATcenter_img Pharmalot Tags drug pricingfinancepharmaceuticalspharmalittleSTAT+ By Elizabeth Cooney Sept. 10, 2018 Reprints Elizabeth Cooney About the Author Reprints [email protected] Good morning. Elizabeth Cooney here, filling in for Ed Silverman today. Coffee is brewed, news is being made, and we’re ready for another working week. Let’s get to it.Compounding companies like Athenex (ATNX) and Imprimis Pharmaceuticals (IMMY) are emerging to meet demand for lower-priced medicines by custom-making drugs, the Wall Street Journal says. That’s sparking legal challenges from such traditional pharmaceutical companies as Allergan (AGN) and Endo Pharmaceuticals (ENDP) and pushback from federal health regulators. “If people start taking compounded drugs because of cost, instead of a generic or new drug, that would undermine the premarket approval system,” said Julie Dohm, the FDA senior science adviser for compounding. @cooney_liz last_img read more

Their baby died during his nap. Then medical bureaucrats deepened the parents’ anguish

first_img By Eric Boodman March 27, 2019 Reprints Comparing the Covid-19 vaccines developed by Pfizer, Moderna, and Johnson & Johnson Special ReportTheir baby died during his nap. Then medical bureaucrats deepened the parents’ anguish MEDFORD, Mass. — The parents were allowed to hold their baby until the medical examiner’s van arrived. Then, they’d have to hand his body over. So Holly and Eric High did what they could to say goodbye. They huddled in an alcove of the emergency room, cradling James in their arms, kissing him, rubbing his hair. They wished the police officer would stop questioning them. They knew she was trying to be gentle. But now, in these last moments with their son, it couldn’t help feeling like an interrogation.There had been no warning. As usual, James had woken before dawn on Sept. 29, 2015. He didn’t cry when he stirred; instead, he made this babbling sound, almost bird-like, more curious than upset. Holly scooped him from his bassinet to breastfeed. Four days earlier, his pediatrician had declared him “perfectly healthy,” and in the gathering light, he looked it, wide-eyed and fat-cheeked at 4 months old.Summer was slipping into fall, the Highs settling into a new routine. That week, Ellie, their 2-year-old, had started ballet. The month before, James had joined her at a home day care run by a neighbor, who’d quickly become their kids’ honorary third grandmother, soothing them through milestones, nudging Ellie from bottle to sippy cup. “She taught us how to be parents,” Eric often said.advertisement Related: Newsletters Sign up for Daily Recap A roundup of STAT’s top stories of the day. Helping those lost in the darkness of grief find themselves again Mancuso added that Riccobene called her, irate, demanding to know who suggested she go public. Six current or former employees confirmed they’ve heard Riccobene speak this way over the phone. They all described being horrified at how office representatives treat families and others. Fearing retaliation, they asked not to be identified.“The office does not believe it is appropriate to comment on private conversations between staff members and grieving families,” Browne said, adding that corrective action is taken if an employee is found to be unprofessional. When reached by phone, Riccobene said, “Do you believe everything these families tell you?” She asked if she could call back. Browne then emailed to say she had no further comment.Medical examiners inspire anger elsewhere, too: Being the face of the state at a parent’s worst moment is, to put it mildly, delicate work. But like diagnoses, attitudes change from person to person, office to office. At a recent SIDS conference, Dr. Mary Ann Sens, who oversees postmortem exams for around 30 counties in North Dakota and Minnesota, explained her method to a group of researchers. She likes to speak to the parents three times, she said, once before and twice after the autopsy. She wants to know what the child was like, how the parents’ religious beliefs influence their understanding of death. She explains how risk factors are different from causes, answers their questions.“It just breaks my heart, sometimes they ask, ‘Will you keep the lights on? They’re afraid of the dark,’” she said. “And I tell them I’ll keep the lights on in the morgue.”A photo of Ellie, Holly, Eric, and James in the entryway of the Highs’ home. James is about 3 1/2 months old in the photo, taken on a merry-go-round at a Pennsylvania amusement park. Holly didn’t know whether she could get pregnant again. Her grief for James was so physical, she wondered if her body had been primed for loss. A miscarriage, in January 2016, came with a grim sense of confirmation.So she wasn’t sure whether to believe it when, one month after that, she slipped out of work at lunch hour to buy a pregnancy test, and it was positive again. The excitement she shared with Eric wasn’t what it had been for Ellie and James. They didn’t buy any baby stuff, didn’t bat around names. They knew how much could go wrong; every milestone was tinged with the terror of waiting. “I remember thinking … ‘I’m just going to lose all my babies,’” she said.That was why, when Goldstein wrote to say he’d heard from the medical examiner and she was free for a meeting on July 14, 2016, Holly decided not to go. “I didn’t want to put my pregnant self into that situation,” she said. “Anything that implied that I did something, missed something with James — I just couldn’t.”Eric figured he’d be overwhelmed, though, and wanted witnesses he could trust. So he asked their kids’ pediatrician, as well as his older brother Heath, an intensive care physician in North Carolina. “The medical examiner … had become this faceless monster,” Eric explained.That morning, his fingers couldn’t keep still, tapping and twisting and fiddling as he and Heath drove downtown. Even the waiting room was behind a locked door. Goldstein met them there, and led them to a conference room upstairs. “That building where his body was,” Eric said, “it was the last place I wanted to be, but I wouldn’t be anywhere else.”It was almost hard to believe when Dr. Faryl Sandler, the medical examiner in charge of James’ case, sat down at the table. Here she was, this doctor whose work had consumed every corner of their thoughts. Eric steeled himself.But before she opened her files, Sandler said she was deeply sorry for his loss. It didn’t put Eric at ease, exactly — nothing, at the moment, in that building, could put him at ease — but he’d needed to hear it, an acknowledgement from the medical examiner that James was a person with a family who deserved care. Suddenly, Sandler became a person for him, too. Holly and Eric High made a book for their daughter, Ellie, to help explain what happened to her brother James. About the Author Reprints Leave this field empty if you’re human: Add in a 1997 true-crime thriller about infanticide — “The Death of Innocents” — and it’s an easy jump to the myth that every unexplained infant death is either carelessness or abuse. “People think SIDS is no longer a problem … but it hasn’t gone away,” said Dr. Rachel Moon, who chairs an American Academy of Pediatrics task force on safe sleep.The decline was real at first — a triumph attributed largely to “Back to Sleep,” but also to upticks in breastfeeding and prenatal care alongside decreases in teen pregnancy and maternal smoking. Then, toward 2000, the downward slope of SIDS began to coincide with increases in other, similar causes of death. What looked like fewer babies dying, the evidence suggested, was now a trend of tragedies being given other names.The boundaries are still blurred, two decades later. It’s partially a problem of definitions. Doctors coined the term SIDS in 1969, hoping to reduce stigma, but, as Goldstein explained, “it’s sort of an anti-category” — a clustering of infant deaths for which no explanation can be found. That leaves a lot of gray. And the United States is a patchwork of postmortem practices. What Dr. Sally Aiken, medical examiner of Spokane County, Wash., calls “sudden unexpected death in infancy,” her counterpart elsewhere might designate “cause unknown” or “accidental suffocation and strangulation in bed.” Because such ways of dying seldom leave distinctive markings on a body, much depends on observations at the scene. Aiken knows that across some state or county lines, risk factors get listed as causes. “It certainly does skew statistics,” she said. A look at how sudden infant death syndrome (SIDS) numbers have changed since 1990. Lumped together, these categories form one of the leading causes of infant mortality in the U.S., after complications of birth and congenital defects: There were 3,600 cases in 2017.To Carrie Shapiro-Mendoza, an epidemiologist at the Centers for Disease Control and Prevention, there’s a pressing need to standardize the way these deaths are investigated and classified. The current system “leads to unreliable statistics … and impedes prevention efforts,” she said.The experts all agree: Babies should sleep on their backs, alone, with no soft bedding. That isn’t a cure-all, though. “The predominant messages are, ‘This problem’s solved, you put your baby on their back and nobody dies from SIDS,’” Goldstein said. “But look at James High. No risk factors.”Even when there are risk factors in a baby’s sleep environment, Goldstein pointed out, there’s usually more to the story. Yet research that might yield a fuller explanation is often dismissed. In 2008, the National Institutes of Health provided $29 million for the study of unexpected infant deaths. By 2017, the figure had withered to $13 million. When discussing his own work on the subject, Goldstein said, he’s heard hospital higher-ups respond, “Oh, I thought that was just people smothering their kids.”Such thinking has a profound effect on parents. It’s sickening enough to know your baby died and science may have no explanation. It’s worse to wait months — or years — for an autopsy report, worrying the death is somehow your fault. It’s worse, still, to hear from the Massachusetts medical examiner’s office that your infant is “not a priority” and that you should not call again.Holly and Eric at home in Salem, Mass. Holly holds James’ swaddling blanket, which they keep in a chest of his belongings. The police had to drive them home. Once there, though, the Highs couldn’t face a house all set up for James. They began to walk, their minds a blur, ending up at the day care. The police were gone now, bedding and bottles taken as evidence. They cried with the owner, told her it wasn’t her fault.There was no one to do that for them. The next morning, investigators from two child welfare agencies showed up, unannounced. The next week, the Highs got a bill for James’ trip to the emergency room: $1,365 for the attempted resuscitation, $2.87 for the bag of dextrose and water to keep him hydrated and fed. The hospital’s financial department called, asking if they intended to pay.The medical examiner’s office was supposed to refer parents like the Highs to the Massachusetts Center for Unexpected Infant and Child Death, for free grief support. Parents’ isolation can be intense, explained Shari King, who directs that program. Friends become afraid to say the baby’s name. Some parents, consumed with loss, see their child’s face in the features of strangers. “People need to know they aren’t crazy,” King said.But the Highs heard nothing. Holly ached everywhere; all she wanted to do was sleep, clutching a piece of James’ clothing like a talisman. Her mother tried to coax her to eat. Everything was a reminder of his absence. She and Eric saw babies everywhere. They discarded the clothes they’d been wearing that day.Holly had loved nursing James, the intimacy of it. Now, she and Eric sat together crying as she pumped, only to throw her milk away. “I was really mad at my body for not knowing to stop,” she said.They had a memorial service to arrange, but knew nothing about what was happening with James’ physical remains. “They didn’t even tell us that his body was ready to be picked up by a funeral home,” remembered Eric. So, after mustering courage for a few days, he called the medical examiner’s office. The conversation made him hope he never had to phone again: “It was very gruff and matter-of-fact, like, ‘His body is waiting.’”Holly and Eric had many more questions — all pressing, all seemingly unanswerable. Some they dealt with as best they could. To help explain what death is to their 2-year-old, they adapted a classic book on losing a sibling — “Where’s Jess?” — and read it to Ellie. She was the reason they kept getting up in the morning. When she woke in the middle of the night, wanting to talk to James, they closed their eyes and sat with her as she told her brother about her day.Other questions lingered. While Holly was pregnant with Ellie, a bright patch had appeared in her 20-week scan: a growth on the baby’s lung. “The best you can hope for is that she outgrows it,” they remembered the surgeon saying. “But if it outgrows her, then you’re not going to have a baby.” Even once she was born healthy, they were on tenterhooks, knowing she would need surgery in a year. When the procedure finally arrived, Eric forbade his mother from snapping pictures: No matter how adorable Ellie was in her hospital gown, this was a day they wanted to forget. Now, they couldn’t stop wondering if James’ death was somehow related.On that day, the state trooper had mentioned that the toxicology report would take around six weeks. But the date came and went. They heard nothing. Was there something they’d missed? Their worries filled the medical examiner’s silence. “Are we not hearing back from the ME’s office because there is something about his case that is making them …” Eric paused, as if he couldn’t even contemplate the thought. “Is there something suspicious we don’t know?”Often, everyday interactions didn’t help. After the Highs’ neighbor decided to retire, they told the director of a new day care that they had a son who died as an infant; she responded: “What was in the crib?” They tried to give away their baby equipment, Eric said, “but nobody would take it.”“Even the car seat,” added Holly. “Nobody wanted that.”“They feel like your kid is tainted. Or cursed.”“They feel like the same thing is going to happen to their kid.”A photo of James at 4 months old and the urn containing his ashes (left) on the Highs’ bureau. It was the accusation that struck Goldstein when he first witnessed the aftermath of SIDS. He was about 22, still years away from being a physician. His interest in the body had arisen only because his own was under attack. As a philosophy and ethnomusicology student at Wesleyan University, he’d spent a few months in south India, learning a lute-like instrument called the veena and unknowingly cultivating within his gut a wriggling mass of parasites.Standing in the throng outside a government clinic with a cup of his own diarrhea changed him. He saw just how much politics could scar the body. “Most of us were in line for something you could treat — or prevent with just good water — and they were all wrecked,” he said.To get a taste for medicine, he volunteered at an emergency room in his hometown of Vineland, N.J. “One morning, they brought in … I didn’t know what they brought in; it’s so unusual for an ambulance to pull up with no sirens and no lights,” he said. It was a bundle about the size of a shoebox, a tiny wrapped thing in the middle of a stretcher. The parents followed after, shadowed by a policeman. They looked utterly crushed, but the officer didn’t have the solicitous air of someone providing support; instead, he loomed, hand by his holster, walkie-talkie crackling. When the doctor unwrapped the child, a fly that had been trapped in the blankets buzzed out and up toward the mother’s face. She started to swat it, but then stopped, her hand in midair, as if, Goldstein said, she were suddenly afraid.Over three decades later — after Harvard Medical School, after work in pediatric palliative care — those scenes in India and New Jersey continue to shape Goldstein’s work. He still has something of the philosophy student about him, a kind of contrarian twinkle. But rather than Marx and Hegel, his arguments now focus on how the bureaucratic and the biological intersect. He’s so obsessed, he needs a reminder, taped to the corner of his computer: “Food for thought is no substitute for the real thing.”To him, giving parents as rigorous answers as possible about their infant’s death is the best avenue to healthy grief. So, in 2012, he co-founded Robert’s Program at Boston Children’s. It offers both bereavement support and inclusion in research studies, for free. (Goldstein turns down cases in which there’s any suspicion of abuse, and refuses requests to be a paid expert witness.)His team sifts through neurons and genomes, looking for patterns that might help explain these deaths, publishing findings in statistic-studded papers, but also giving parents a personalized report about their child — providing them the kind of science that cash-strapped state labs often can’t.Dr. Richard Goldstein in his office at Boston Children’s Hospital. The Highs found Goldstein the way they found most support services: Holly searching online late at night, sending emails, one person leading to the next — a grief-stricken scavenger hunt. Among these hints and clues, Robert’s Program represented something new: Someone besides the medical examiner who might explain what happened.By their intake appointment in January 2016, three and a half months after James’ death, they still weren’t leaving the house for anything besides absolute necessities. They drove in silence, readying themselves to relive the trauma of that day. Goldstein led them into a small exam room.His focus, he explained, was the oft-neglected contribution of underlying biological abnormalities: metabolic disorders, cardiac disruptions, brain malformations that might rob infants of certain lifesaving reflexes if the baby’s airway were obstructed. That’s what his team would be looking for.But the program also offered another boon: the relationship Goldstein spent years forging with the Massachusetts medical examiner’s office. The agency provided tissue samples for Goldstein’s research. His program deepened the official search for a cause of death. They jointly explained their findings to the family in person at the end.That was part of the allure for the Highs. They signed consent forms, sketched family trees, gave blood. They answered Goldstein’s questions in the hope that it would help him answer their own: Should they worry about Ellie? Would having another baby mean this would happen again? They needed some kind of an explanation, and had heard nothing from the fortress-like agency that had taken their kid.Ellie’s drawing of her family hangs above her and Warren’s bunk bed. From left, Mom, James, Penny (the dog), Warren, Dad, and Ellie. Wedged between hospitals and highways, the Massachusetts Office of the Chief Medical Examiner is a squat construction of redbrick and gray, its concrete crumbling at the corners. Outside, ambulance drivers take cigarette breaks as traffic whispers on and off I-93.Inside, the place has been troubled for years: short-staffed, underfunded, backlogged, overwhelmed by the bodies of the opioid crisis. When the last chief retired, the agency was not meeting the national target of finishing 90 percent of autopsy reports within 90 days of examining the cadaver.Then, in October 2017, Dr. Mindy Hull took over the job. By August 2018, she’d met that goal — but not for infants, whose cases tend to be more complex. Sixteen of the 56 baby investigations from 2017 and 23 of the 57 from 2018 were still pending this month, said spokesman Felix Browne.What bereaved parents noticed about Hull’s tenure, besides the wait, was the slashing of support services. When the two licensed social workers employed as family liaisons left, Hull didn’t replace them. Instead, in a January 2018 email to employees, chief of staff Lisa Riccobene said she would handle any “family that is difficult to reason with” — a duty she kept after the Boston Globe revealed, months later, that she’d falsely claimed to have a psychology degree.Hull’s staff stopped meeting with Robert’s Program families and Goldstein. Her office also stopped automatically making referrals to the Center for Unexpected Infant and Child Death; the center’s grief counseling caseload plummeted from 30 or 35 families a year to under 20.Cutting off these referrals, Goldstein worries, will exacerbate a problem that’s already apparent. Sudden unexpected infant deaths are significantly more common in poor, Native American, and black families, but those groups are less likely to get support services.The office does not consider such programs essential, Browne said, and needs fewer liaisons because wait times have decreased overall (though the agency’s pace is now behind the national standard again, the Globe reported this month). The agency, he added, is hiring more doctors and “remains focused on its mission to deliver timely information to citizens of the Commonwealth.”Parents like the Highs didn’t stop needing support, though. All five Massachusetts families interviewed for this article described being stuck in limbo during the 10 months or more they spent waiting for news from the medical examiner. One mother said she was told to stop calling; another was told the documents would come whenever they were ready. Meanwhile, these parents were terrified their other children would stop breathing, too. Again and again, they’d touch their kids’ chests at night, to double-check.“It’s infuriating,” said Rebecca Smerling of Lexington, who is still waiting, 13 months after the death of her 5-week-old, Drew.Jodi Bissonnette of Dedham, who lost 2-month-old Thomas in 2018, spent a year worrying the culprit was some contaminant in her breast milk or her house. “I don’t want someone touching my son and not giving me answers,” she said. “It tears you apart, every night, every day, every hour: ‘What could I have done differently?’”After losing 28-day-old Ambrose in 2016, Maggie Moran Mancuso of Dorchester said she spent nearly three years calling the medical examiner’s office and being told, “Your baby’s not a priority.” Finally, this past January, a kindly employee suggested she might have more success getting an autopsy report if she put political pressure on the office. She wrote to her state representative; within a few days, Ambrose’s case was closed. “It’s almost like you’re in purgatory,” said Mancuso, who founded a support group called Ambrose’s Angels. “The amount of pain they add to each family — they have no clue … how much more torture it was than it had to be.” Photos by Alissa Ambrose Motion graphics by Hyacinth Empinado Privacy Policy Trending Now: James was no longer James by the time they got to the hospital. He was tiny in the middle of a full-sized bed. The team had been working on him for a while — jolting him with epinephrine, coaxing his lungs to breathe — and had gotten no response, they told Eric when he arrived. They wanted to know when they should stop.“I need you to keep working on him until my wife gets here,” he remembered saying. He held James’ hand while the doctors tried to bring him back to life.Holly collapsed as soon as she walked in. “I just want to hold him,” she said again and again.He was declared dead at 2:34 p.m. Someone remembered the mementoes that hospitals collect for the family when a baby is stillborn. They pressed the soles of James’ feet into ink and made prints, right and left, slid them into a frame frilled with white lace. They cut a lock of his hair.Then, they swaddled him, pulled on a newborn’s hat, and handed him back to his parents to hold under the supervision of a Medford detective. A state trooper stood nearby. The Highs, both then 30, were grateful the police had called their family members and arranged for Ellie to go to a friend’s house. Now they wanted the officers to go away. They answered questions in a daze. No, they had no concerns about the day care provider. James had been a bit fussier than usual, but it was just a growth spurt. He’d been drinking mostly breast milk with a small supplement of formula — Similac, the blue can. No, he’d had no fevers. Yes, he always slept on his back.When the time came, Eric refused to pass James to a stranger. He was allowed to carry the body to the edge of the premises himself, down a long hallway toward the loading dock. The medical examiner’s employee was waiting.“She was like, ‘We’ll take good care of him, don’t worry,’” Eric remembered. “Then I handed him to her because I had to.”He walked back to Holly, and recalls being told, “OK, you guys can go home.” Eric laughs quietly at the memory of it. In retrospect, the wording probably wasn’t that callous, but that’s how it felt right then: Once Eric and Holly had answered questions and given up their infant, officials had no use for them. The Highs were left wondering whether they’d somehow done something wrong.“I don’t think I can drive,” Eric replied.Holly holds prints of James’ feet and a lock of his hair. It’s hard to imagine anything that could deepen the grief of losing a child. Parents who’ve experienced it echo King David: You wish you could have died instead. The tiniest actions — controlling a car, even climbing out of bed — seem insurmountable. You fill out forms, make funeral arrangements through a fog.When an infant unexpectedly stops breathing during sleep, the usual bureaucracy of death is multiplied, the paperwork thickened with accusation. Investigations are triggered with the local police, the state police, the agency that checks for child abuse. In some jurisdictions, officials appear soon afterward, asking parents to re-enact what happened, a doll standing in for their baby. The medical examiner or coroner takes the body, to determine a cause of death, looking for hints of “foul play.”These protocols are designed to protect. Often they do. But how an officer or medical examiner carries them out can sharpen the suspicion inherent in any investigation, heightening parents’ self-blame even when there’s no evidence of wrongdoing. As director of a Boston Children’s Hospital program that studies unexpected child deaths, Dr. Richard Goldstein hears such stories all the time. An officer tells parents their house is a crime scene; a state employee says no, you can’t hold your baby, we’re putting him into a body bag.Goldstein knows such lapses in compassion are partially born of confusion. It’s lurked on death certificates for ages, but took a new, more visible turn in the 1980s, with growing evidence that “cot deaths” were rarer when infants slept on their backs. The news traveled through Australian studies and European advisories, eventually bursting out of American radios and TVs in 1994, with a public health campaign called “Back to Sleep.”The rate of “sudden infant death syndrome” plummeted — and kindled that old nemesis of statisticians everywhere, the conflation of risk factor and cause. Americans mistakenly thought that belly sleeping, which can increase a baby’s likelihood of dying, was the clear-cut reason someone’s infant died. They dropped the kids off with her around 8 a.m., Ellie running in to play with her friends. James’ eyes crinkled closed when he smiled.For years afterward, their bodies would remember the time of day when it happened: Whenever Holly was sitting at her desk and felt a blinding rise in panic, she knew it was around 1:30 in the afternoon. The police reached Eric first, calling and calling until he stepped out of the chemistry lab he was teaching at Tufts University. James was being taken to Lawrence Memorial Hospital. They wouldn’t tell Eric what was wrong.It was Holly who called the day care from her actuarial office in downtown Boston, who heard their neighbor coming apart on the phone. James never woke from his nap, she said. When she checked on him, his skin was blue.advertisement General Assignment Reporter Eric focuses on narrative features, exploring the startling ways that science and medicine affect people’s lives. @ericboodman [email protected] Then, she moved through the autopsy report. He remembered her telling him that everything in James’ sleep environment seems to have been safe, that he was a perfectly healthy, normal baby. The manner of death was “natural.”As unsatisfying as that answer was, Eric was relieved. James was a classic SIDS case. At least they had a name for what happened.Then it was Goldstein’s turn. His team had found, in James’ brain, mild malformations of the hippocampus, which they’d observed in other babies who’d died suddenly and unexpectedly. Layers of cells that should have been stitched together were pulling apart. Coils of tissue that should have looked the same in both hemispheres of the brain showed asymmetries.The most common of these anomalies — found, according to Goldstein’s research, in 41 percent of infants who’d died without explanation but only 8 percent of those with a clear cause of death — was also a classic sign of temporal lobe epilepsy. Goldstein couldn’t say whether James had died with or from the miswiring in his brain. The science wasn’t strong enough yet. He could offer only correlation, not causation, a hypothesis that James may have had a seizure.They’d also detected a genetic mutation in both Eric and James, potentially linked to electrical signals in the nervous system and —That’s when Eric lost it.He doesn’t cry easily. He’s more likely to let out a sad, disbelieving laugh. But now his eyes welled up, his voice caught in his throat. All he could think was: “It’s my fault.”Everyone in the conference room tried to reassure him. Only Holly could. Later that afternoon, as they wandered through their neighborhood by the Mystic River, she was firm: It wasn’t Eric’s fault. It wasn’t anybody’s fault. It just happened.The genetic variant proved, with more research, to be harmless, and Warren James High was born healthy on Nov. 7, 2016.The autopsy report finally arrived at the Highs’ in February 2018, more than 18 months after the meeting with the medical examiner, two and a half years after James’ death — so long that Eric had figured the summary was never coming, and had stopped rushing home before Holly so she wouldn’t have to find it in their daily scattering of mail. She opened the thick envelope and got halfway through the first paragraph before realizing that its clinical details made her feel sick.Eric hid the report in a drawer at work. “It’s not something I ever want to read,” he said. “It’s about just getting an official document that they’re done, so we can put it in a box, and know that XYZ investigations are finished.”Holly, Ellie, and Eric on an unseasonably warm December afternoon at a playground near their home in Salem. The High family walk across Salem Common on Holly and Eric’s ninth wedding anniversary in December. Warren and Eric at the playground. The hardest times are the happiest times, those moments when you feel good but also guilty for feeling good, as if even an instant of unequivocal joy without James is not allowed. Tonight is one of those times. It’s a Friday evening in December, the Highs’ new apartment in Salem filled with the everyday release once school and work are done. The kids come tearing in and they’re everywhere at once, wriggling out of their coats, hugging their dad around the legs, shrieking through every room in the house.Holly follows after them carrying a sheaf of Ellie’s artwork, a portrait of a pumpkin in thick brushstrokes visible beneath her hand. She yawns, still wearing her coat, as she picks the kids’ jackets up from the living room floor and carries them to the two hooks by the entrance, under the framed portraits of their three kids.Eric had procrastinated about putting up those hooks. The task, simple as it was, was a reminder that they only had two jackets, two schoolbags to hang up. In the same way, he and Holly hesitate when someone asks how many children they have. They don’t always want to reveal something so painful, so personal — at a work conference, or in the elevator — but James is one of their kids. Sometimes, they use Goldstein’s findings, telling people their son had a brainstem abnormality and died, so they don’t have to get The Look that comes when they talk about SIDS.Now Warren is on the kitchen floor doing his 2-year-old approximation of his big sister’s cartwheels, a kind of wiggle-somersault. Ellie is making a fort among the pillows of her parents’ bed.Each of these evenings is at once routine and unique, structured by parents, colored by the idiosyncrasies of little kids. Sometimes they go to the playground in the last of the winter light, racing each other across the frost-hardened grass. Sometimes Warren says no to every food in the fridge except cake, and his parents tell him that he can’t just eat cake. Sometimes Ellie makes slime, kneading dye in until it becomes the right hue. Sometimes, they have get-your-energy-out dance parties, Warren toddling circles around Ellie as she twirls and spins.Sometimes, once she’s all danced out, instead of asking for “Don’t Let the Pigeon Drive the Bus!”, Ellie wants to hear James’ book. So Eric pulls it from the shelf, cuddles up with her and Warren on their bunk bed, holds the pages wide, and begins to read: “I asked Mommy and Daddy, ‘Where’s James?’ They told me James is dead. I wanted to know what dead is. ‘Is dead like sleeping?’ Mommy said dead was not like sleeping.” Eric Boodman Please enter a valid email address. Tags Bostonpediatricslast_img read more

After retractions of two Covid-19 papers, scientists ask what went wrong

first_imgIn the Lab Tags CoronavirusresearchSTAT+ Sharon Begley By Sharon Begley June 8, 2020 Reprints With last week’s retractions of two Covid-19 papers from a pair of the world’s top medical journals, the scientific community is once again wrestling with the question that arises any time a high-profile publication blows up: Could this have been prevented?Entire forests have been felled so scholars can write papers on “the flawed process” of peer review, in which journal editors ask (usually three) outside experts to read a manuscript for rigor, methodological soundness, consistency, and overall quality. Peer review is rife with gender bias. Reviewers try to block competitors’ papers. They steal ideas. They favor authors from prestigious institutions. The process is hardly better than chance at keeping bad studies from being published. It does little to improve papers. Senior Writer, Science and Discovery (1956-2021) Sharon covered science and discovery. @sxbegle Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED After retractions of two Covid-19 papers, scientists ask what went wrong 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.center_img What’s included? GET STARTED About the Author Reprints What is it? Adobe 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. [email protected] Log In | Learn More last_img read more