Uncertainty haunts parents of Flint, as every rash, every tantrum raises alarms

first_img Fowler’s 19-year-old son, Jared, has autism; her 12-year-old, Taylor, is deaf. “My kids had it tough to begin with and to think that they’ve fought so hard to do well only to be poisoned by this water and possibly face additional damage — it’s unimaginable,” she said. Hanna-Attisha’s research found that 4.9 percent of Flint children under the age of 5 had elevated blood lead levels after the city began drawing water from the Flint River, compared with 2.4 percent before that switch. In one ward, nearly 16 percent of young children had elevated lead levels, compared to just under 5 percent previously.   It was a stunning finding, which garnered immediate attention — and a backlash from state officials — when Hanna-Attisha presented the results publicly last September. But she believes it almost certainly underestimates the problem. Elizabeth Tramble worries about the long-term effects of Flint’s water on her children. Fabrizio Costantini for STATIn part, that’s because blood tests don’t capture the extent of past exposure to lead. Also, available data exclude even more vulnerable populations — pregnant women, infants in utero, and babies who are fed formula, typically mixed with tap water, in the first few months of life. The county health department doesn’t test lead levels in adults, either, though they, too, can suffer adverse health effects, including elevated blood pressure, altered kidney function, and declines in cognitive function.On top of the lead, residents suspect other contaminants in the river. Ten people in Flint have died from Legionnaire’s Disease, a lung infection caused by bacteria that thrives in water, since the city began using the Flint River for drinking water. “We’re not just worried about the lead, we’re worried about everything that’s in the water, and they haven’t come clean about that yet,” said Bill Hammond, 58, a retired industrial hygienist who contracted two serious infections after the city changed its water supply.A defiant 5-year-old raises alarmsElizabeth Tramble, 27, drank Flint River water for seven months during a recent pregnancy, until her older sister Egypt convinced her the health risks were too great. While her baby Lorenna, now 5 months old, seems fine, Tramble doesn’t know if she’ll suffer long-term impacts from the exposure. Tramble’s stepfather, Ronnie Wexler, said he noticed a change in Navaeh last summer. “She didn’t used to be like that,” he said.Wexler is convinced that the city water has something to do with both Navaeh’s outbursts and the strange hair loss experienced by her 6-year-old sister, Tatinasia, who now has a softball-sized bald spot on the back of her head. A doctor told Tramble last year that the little girl had a fungus, but medicine didn’t help and she has to wear a scarf to school to cover it up.Tatinasia Hall, 6, has patches of hair missing on her head; her family blames the polluted water. Fabrizio Costantini for STATNo answers for parentsOne of the most painful aspects of the crisis is that medical professionals have few answers for anxious residents.The only treatment for lead poisoning, chelation therapy, is used only in the most severe cases and isn’t appropriate for people with lower blood lead levels, like those seen in Flint.So people are left to watch for symptoms. And to worry.Hanna-Attisha advises parents to make sure their kids are getting plenty of calcium, iron, and vitamins C and D; a diet rich in those nutrients can slow absorption of lead into bones and organs. But it can be hard to get a nutritionally balanced diet in Flint, which is so disadvantaged, it doesn’t even have a supermarket.The doctor is also pressing for more investment in services: expanded Head Start programs for toddlers, universal preschool, more food aid for mothers and infants, and mental health counseling. “We cannot sit back,” she said. “We have to throw every evidence-based intervention at these kids now to mitigate possible damage.” Under Hanna-Attisha’s direction, and in partnership with Michigan State University, a new Pediatric Public Health Initiative will follow 9,000 Flint children under age 6 who were exposed to the city’s tap water in the past two years. It’s likely that the children will be monitored regularly for years by pediatricians, psychologists, child development specialists, epidemiologists, educators, and other experts.None of that’s enough to give locals confidence in the future.Tiffany Burene and her 8-year-old son have had health problems she believes stem from the contaminated water. Fabrizio Costantini for STATWishing for an escapeTiffany Burene, 33, has lived in Flint all her life, but now wants to leave. She can’t, though, she said. She doesn’t have the money. Like many people in this city, Burene started drinking bottled water a year ago, after the city told residents that the tap water contained elevated levels of total trihalomethanes, a carcinogenic byproduct of chlorine. But in August, she ran out of money and began drinking river water from the faucet again. Several days later, she awoke with her stomach cramping, rushed to the bathroom and found the toilet full of blood. An emergency room physician diagnosed colitis, a condition she hadn’t had previously.“It scared me. And I still have stomach issues to this day,” said Burene, who also had a stretch of alarming hair loss last year.Nothing, however, has worried Burene so much as what’s happened to her 9-year-old son, Gabe, who was diagnosed with attention deficit hyperactivity disorder and bipolar disorder at the age of 5.  “That little boy is my everything and I don’t know what’s going on,” Burene said. “Within the last year and a half, his ADHD has gotten worse. He gets very agitated and aggravated very easily. His anger outbursts are getting more frequent.”  It could be a new development stage Gabe is going through — or something else. Burene has no way of knowing.   Tiffany Burene would leave Flint if she had the money. Fabrizio Costantini for STAT“I can’t say 100 percent it’s the lead, but nothing has changed in our household except the water and, honestly, that’s the only way I can put two and two together,” she said. “No matter how many times I take my son to the pediatrician or a therapist, they never find anything.”Echoing other parents across Flint, Burene blames herself for not protecting her son, even though she could not have known about the lead leaching into the water. “Our kids don’t deserve this,” she said, “and it makes me feel like a failure as a parent.” In the meantime, Tramble —a single mother with five girls under the age of 9 — is worried about her 5-year-old, Nevaeh.“She’s very defiant for nothing,” Tramble said last week, sounding tired. “She throws stuff. She acts out real bad. If I tell her ‘No, you can’t hold the baby,’ she just screams. She’s not minding in school. It’s like her attitude has changed and something is wrong with her mentally.” Related: Diana Hernández: Promoting better health through better housing Judy is a STAT correspondent based in Denver. FLINT, Mich. — Uncertainty haunts the mothers and fathers of Flint.No one can tell them how much toxic lead their children may have ingested from polluted drinking water over the past two years.And no one can say for certain what health effects might stem from that exposure. Is the lead to blame for this headache? For that bald spot? For a sudden spate of violent tantrums? Might a child who seems fine now have suffered subtle brain damage that could affect his grades and behavior down the road? advertisement Recognizing the fear pervading this community, physicians and school officials are offering residents tests for lead exposure. But those tests aren’t likely to reveal much.Many families have been drinking bottled water since discovering last year that there was lead in the city’s water; results will reflect that. Lead, a neurotoxin, doesn’t circulate long in the blood before it’s absorbed into bones and other organs or excreted. So a test taken today won’t show how much lead a child ingested a year ago, or what her peak exposure might have been. Volunteers and inmates in a work detail hand out cases of bottled water to residents of Flint. Fabrizio Costantini for STATNor is there any way to definitively link an individual’s exposure to a specific health concern — past, present, or future. All that’s known is that lead exposure can damage multiple organs and the brain, even at very low doses. Children are particularly vulnerable and once harm has occurred, the impact cannot be reversed.“When a child presents with attention deficit hyperactivity disorder, behavioral problems, or intellectual deficits five years from now, I’ll never be certain if it was from the lead or another reason,” said Dr. Mona Hanna-Attisha, a pediatrician whose research on children’s blood lead levels helped call attention to Flint’s water crisis. “When I look into a mom’s eyes,” she said, “that uncertainty is a great cause of anxiety.” The entire community is suffering from toxic stress, Hanna-Attisha said, and needs mental health first aid to cope with this crisis. But services are few and far between, especially for children.A water tower in Flint, where life was hard even before the spate of lead poisoning. Fabrizio Costantini for STATA hard life, made harderLife in Flint was already hard before the city’s switch in April 2014 from Detroit’s water system to the Flint River exposed residents to lead, E. coli bacteria, and a cancer-causing byproduct of chlorine. More than 41 percent of the city’s nearly 100,000 residents are impoverished, unemployment is endemic, 15 percent of homes are boarded up or abandoned, and the murder rate is one of the highest in the nation. Dilapidated buildings and overgrown lots abound. “When I think about my kids and what might happen to them, I can’t sleep,” said Laura Darch, a Flint native who checks her three boys, ages 9, 7, and 5, each day for rashes. Darch has recently sought treatment for intense anxiety and depression. She feels guilty that she let her sons drink from their school water fountains. She can’t stop thinking of how those sips might set back their development.advertisement Now, evidence of government negligence has raised residents’ distress to an even higher level. Officials failed to add anticorrosive agents to water from the Flint River; as a result, old pipes throughout the city began to leach lead into the water supply. For 18 months, residents’ complaints about discolored, foul smelling, and strange tasting water were dismissed or ignored. Officials assured people repeatedly that the water was safe.  Though Flint returned to Detroit’s water system in October, the damage to the city’s aging infrastructure — and its sense of trust in government — was extensive. The US Justice Department, the Environmental Protection Agency, and the Michigan Attorney General are conducting investigations. “Our lives are already so hard. Why would they do this to us?” asked Bethany Hazard, 59, breaking into tears. Hazard lives alone and is disabled by painful osteoarthritis, which she said has become much worse over the last year and a half. “It’s like they just don’t care.”“We screamed at the top of our lungs that the water was hurting us, and they called us crazy, irrational, fear mongerers,” said Florlisa Stebbins Fowler, 37, a single mom who became a community activist after her three children suffered inflamed skin after showering and diarrhea after drinking the water. By Judith Graham Jan. 29, 2016 Reprints Tags ADHDlead exposurepublic healthcenter_img Elizabeth Tramble worries about how the lead in Flint’s drinking water will affect her children. Fabrizio Costantini for STAT “I don’t feel safe,” she said. “I have never felt so unsafe in my life.” HealthUncertainty haunts parents of Flint, as every rash, every tantrum raises alarms @judith_graham Crisis in Flint shows how far we’ve come on lead. And how far we need to go. Related: Judith Graham About the Author Reprints Related: Watch: Episode 3: Scientists are building mini-brains to understand the human mind last_img read more

Watch: Episode 4: Can a worm’s lifespan hold the secrets to human aging?

first_img Harvard Medical School researcher Nicholas Stroustrup built what he calls the “Lifespan Machine.” He uses it to study the lives of tiny worms to try and discover universal rules of aging. Matthew Orr/STAT Episode 4: Can a worm’s lifespan hold the secrets to human aging?Volume 0%Press shift question mark to access a list of keyboard shortcutsKeyboard ShortcutsEnabledDisabledPlay/PauseSPACEIncrease Volume↑Decrease Volume↓Seek Forward→Seek Backward←Captions On/OffcFullscreen/Exit FullscreenfMute/UnmutemSeek %0-9 facebook twitter Email Linkhttps://www.statnews.com/2016/04/04/worms-aging-lifespan-machine/?jwsource=clCopied EmbedCopiedLive00:0004:5504:55  Tags agingdeathHarvard Medical School By Carl Zimmer April 4, 2016 Reprints For my latest episode of “Science Happens,” I pay a visit to an extraordinary experiment in aging called the Lifespan Machine. It was created by Nicholas Stroustrup, a postdoctoral researcher in the Department of Systems Biology at Harvard Medical School. Stroustrup and his colleagues study tiny worms that only live a few weeks at most. By observing thousands of genetically identical worms live out their entire lives in precisely the same conditions, Stroustrup is discovering universal rules of aging — rules that might help explain our own decline, too. This story was originally posted Feb. 2, 2016. Science Happens!Watch: Episode 4: Can a worm’s lifespan hold the secrets to human aging? Why do we get old and die? It’s one of the biggest questions in life. And the answer might someday change the practice of medicine. Instead of treating one disease or another, doctors might instead treat aging itself. While that approach might not lead to immortality, it could potentially allow people to trade weak, frail old age for vigorous golden years.As important as the question is, it’s enormously hard to answer. That’s because it demands a lot of data. Scientists can pore over death records, but those won’t reveal what kind of genetic influences caused someone to die young, or what childhood secret allowed another to live to a ripe old age.Watch more: Scientists are building mini-brains to understand the human mindFortunately, our course of aging isn’t radically different from that of other species. So scientists have turned to animals to understand the aging process.advertisementlast_img read more

Pricey drugs overwhelm Medicare safeguard

first_img Tags drug priceshepatitis CMedicare Gilead and Massachusetts agree to rebates for hep C drugs Medicaid spends a lot on outpatient drugs, but which cost the most? Matt Rourke/AP By Associated Press July 25, 2016 Reprints Inside the $100 million ad blitz for a $1,100-a-pill drug for hepatitis C “If the numbers continue to increase like this each year, I worry about how much the taxpayers could afford,” said Grassley, who plans to ask Medicare for explanations.“It may be that some drug companies are taking advantage of government programs to maximize their market share, and we need to know whether that’s the case,” he added.Catastrophic coverage will soon cost as much as the entire prescription program did when it launched, said Senator Ron Wyden (D-Ore). “Congress can’t continue to stand idle.”Experts say the rapid rise in spending for pricey drugs threatens to make the popular prescription benefit financially unsustainable.Nonpartisan congressional advisers at the Medicare Payment Advisory Commission have called for an overhaul. The presidential candidates, as well as the Obama administration, have proposed giving Medicare legal authority to negotiate prices.The drug industry says Medicare patients are getting valuable, innovative medicines.Lisa Joldersma, policy vice president for the Pharmaceutical Research and Manufacturers of America, also questioned the cost numbers. “I would push back on the notion that taxpayers are bearing 80 percent of the risk here because the numbers do not reflect rebates,” she said. Related: Rebates for individual drugs are not disclosed. They averaged nearly 13 percent across the entire program in 2013, according to government figures, and were estimated at about 17 percent for 2015.Most beneficiaries haven’t seen a drastic hit yet from rising drug costs, but that may be changing. This year, average premiums went up more than 15 percent in five of the top eight drug plans, according to the Kaiser Family Foundation.Concerns about catastrophic costs undercut the image of Medicare’s prescription program as a competitive marketplace in which private insurers bargain with drugmakers to drive down prices.“The incentive is to price it as high as they can,” said Jim Yocum, senior vice president of Connecture, Inc., a company that tracks drug prices. Medicare is barred from negotiating prices, “so you max out your pricing and most of that risk is covered by the federal government.”An architect of the program says no one anticipated $1,000 pills. Former Medicare administrator Tom Scully said catastrophic coverage was meant to protect patients taking many different medicines over months and years.“The pricing is pretty wild,” he said.— Ricardo Alonso-Zaldivar Related:center_img Medicare’s catastrophic coverage was originally designed to protect seniors with multiple chronic conditions from the cumulatively high costs of taking many different pills. Beneficiaries pay 5 percent after they have spent $4,850 of their own money. With some drugs now costing more than $1,000 per pill, that threshold can be crossed quickly.advertisement Associated Press Lawmakers who created Part D in 2003 also hoped added protection would entice insurers to participate in the program. Medicare pays 80 percent of the cost of drugs above a catastrophic threshold that combines spending by the beneficiary and the insurer. That means taxpayers, not insurers, bear the exposure for the most expensive patients.The numbers provided to the Associated Press reflect the total paid by taxpayers, insurers, and beneficiaries. They offer a glimpse into the volatile and often mysterious world of high-cost drugs:Catastrophic spending for Harvoni and Sovaldi — two hepatitis C pills from Gilead Sciences — more than doubled in two years, from about $3.5 billion in 2014 to nearly $7.5 billion in 2015. Harvoni topped the list of Medicare’s high-cost drugs last year; Sovaldi was first in 2014. The FDA approved Sovaldi in December 2013, and its $1,000-per-pill price quickly made headlines. A congressional investigation last year found that Gilead was focused on maximizing revenue, even as a company analysis showed that a lower price would allow more patients to be treated.Revlimid, a cancer drug derived from 1950s thalidomide, surpassed $1.7 billion in catastrophic costs in 2015, coming in second among high-cost drugs. Spending on the medication from biotech company Celgene increased by 50 percent in three years.Gleevec, a breakthrough drug introduced in 2001 to treat leukemia, was ensconced as fifth among the top 10 pricey medications, with more than $1 billion spent in 2015. That was a 54-percent increase from 2013. Drugmaker Novartis has been criticized for repeatedly hiking the price of Gleevec.Catastrophic spending accounts for a fast-growing share of Medicare’s drug costs, which totaled nearly $137 billion in 2015. The catastrophic share was 37 percent, yet only about 9 percent of beneficiaries reached the threshold for such costs. For those patients, average spending jumped by 46 percent, from $9,666 in 2013 to $14,100 in 2015. WASHINGTON — A safeguard for Medicare beneficiaries has become a way for drug makers to get paid billions of dollars for pricey medications at taxpayer expense, government numbers show.The cost of Medicare’s “catastrophic” prescription coverage jumped by 85 percent in three years, from $27.7 billion in 2013 to $51.3 billion in 2015, according to the program’s number-crunching Office of the Actuary.Out of some 2,750 drugs covered by Medicare’s Part D benefit, two pills for hepatitis C infection — Harvoni and Sovaldi — accounted for nearly $7.5 billion in catastrophic drug costs in 2015.advertisement Related: About the Author Reprints BusinessPricey drugs overwhelm Medicare safeguard The pharmaceutical industry questions the numbers, saying they overstate costs because they don’t factor in manufacturer rebates. However, rebates are not publicly disclosed. Senator Charles Grassley (R-Iowa) is calling the rise in spending “alarming.”last_img read more

Few opioid-addicted youth get standard treatment medication

first_img Please enter a valid email address. About the Author Reprints WATCH: How you fight opioid addiction — with opioids Leave this field empty if you’re human: “The take-home message for parents is: If you have a child struggling with opioid addiction, understand that there are medications that support and sustain recovery,” said study author Dr. Scott Hadland of Boston Medical Center.advertisement By Associated Press June 19, 2017 Reprints Hadland was following a hunch when he began the study last year. In his practice, he was seeing more young people addicted to opioids. Many already had been through multiple treatment programs and they told him they’d never before been offered treatment medication.Doctors must become more comfortable treating addiction with medications, Hadland said, noting that buprenorphine and naltrexone are recommended by the American Academy of Pediatrics.Buprenorphine is given daily as a pill or film that dissolves under the tongue. It costs about $100 a month. Doctors need special training and a government waiver to prescribe it. A common version of buprenorphine is Suboxone.Vivitrol is a brand-name version of naltrexone. It’s a shot given once a month and can be used only with patients who have completely detoxed from opioids. It costs about $1,000 per month. All were diagnosed with opioid addiction, but only 27 percent were given buprenorphine or naltrexone during 2001-2014, years when addiction was soaring. Privacy Policy Associated Presscenter_img Newsletters Sign up for Morning Rounds Your daily dose of news in health and medicine. CHICAGO — Only 1 in 4 teens and young adults with opioid addiction receive recommended treatment medication despite having good health insurance, according to a study that suggests doctors are not keeping up with the needs of youth caught up in the worst addiction crisis in U.S. history.“Young people may be dying because they are not getting the treatment they need,” said Brendan Saloner, an addiction researcher at Johns Hopkins Bloomberg School of Public Health who wrote an editorial published with the study Monday in JAMA Pediatrics.Researchers looked at records for nearly 21,000 patients ages 13 to 25 from one large insurance carrier, UnitedHealthcare.advertisement A new study finds only 1 in 4 teens and young adults with opioid addiction receive recommended treatment medication despite having good health insurance. Carla K. Johnson/AP HealthFew opioid-addicted youth get standard treatment medication Related: The drugs work slightly differently, but both can ease cravings while patients work on addiction issues in counseling.In the study, females, blacks and Hispanics were even less likely to receive the medications than males and whites. It’s unclear why, but unequal access to care or doctor bias could be to blame.“The treatment gap is bad for everybody and even worse for certain subgroups,” Hadland said. “Even though all the youth in our sample had access to high-quality health insurance, they may not have had equal access to high-quality addiction care.”Hadland and his colleagues plan to study access to treatment medications for youth from low-income families covered by government health insurance programs such as Medicaid.— Carla K. Johnson Tags opioidslast_img read more

Up and down the ladder: The latest comings and goings

first_img Hired someone new and exciting? Promoting a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.And here is our regular feature in which we highlight a different person each week. This time around, we note that Restorbio (TORC) hired Dr. Kerry Russell as vice president of clinical development. Previously, she worked at Novartis (NVS), where she was director and senior translational medicine expert in the cardiovascular division of the Novartis Institutes for Biomedical Research. Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+. First 30 days free. GET STARTED What is it? Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Pharmalot @Pharmalot Log In | Learn More GET STARTED By Ed Silverman June 15, 2018 Reprints What’s included?center_img [email protected] Tags pharmaceuticalsrecruitmentSTAT+ Ed Silverman Up and down the ladder: The latest comings and goings Alex Hogan/STAT About the Author Reprints Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. 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.last_img read more

Pharmalittle: Will a small biotech upend the cholesterol market? J&J loses patent protection on key drug

first_img What’s included? Pharmalot By Ed Silverman Oct. 29, 2018 Reprints Good morning, everyone, and welcome to another working week. We hope the weekend was refreshing and relaxing, because that demanding routine of deadlines and meetings has returned. You knew this was inevitable, yes? Well, to cope, perhaps you would like to join us for a cup of stimulation to fortify those nerve endings. We are opting for golden French toast, by the way. So time to get started. Here are some items of interest. Hope your day goes well and do stay in touch …Esperion Therapeutics (ESPR) reported that a combination of its once-a-day cholesterol pill and a maximum dose of a statin lowered LDL cholesterol 18 percent more than statins alone after 12 weeks, STAT reports. The results come from the last of five successful trials on the drug, called bempedoic acid, whose data the company plans to submit to the Food and Drug Administration in the early months of 2019. To cardiologists, the most important finding related to safety. In the 779-patient study, the drug was indistinguishable from placebo when it came to side effects and deaths. GET STARTED @Pharmalot STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. What is it? Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Tags financelegalpatient safetypharmaceuticalspharmalittleSTAT+taxescenter_img Ed Silverman 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. Alex Hogan/STAT Pharmalittle: Will a small biotech upend the cholesterol market? J&J loses patent protection on key drug [email protected] About the Author Reprints Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry.last_img read more

The mark of a job well done for a CRISPR lobbyist? Silence in Congress

first_img What is it? Politics Hyacinth Empinado/STAT GET STARTED By Nicholas Florko March 27, 2019 Reprints Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Log In | Learn More STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. Daily reporting and analysis The most comprehensive industry coverage from a powerhouse team of reporters Subscriber-only newsletters Daily newsletters to brief you on the most important industry news of the day STAT+ Conversations Weekly opportunities to engage with our reporters and leading industry experts in live video conversations Exclusive industry events Premium access to subscriber-only networking events around the country The best reporters in the industry The most trusted and well-connected newsroom in the health care industry And much more Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr. About the Author Reprintscenter_img The mark of a job well done for a CRISPR lobbyist? Silence in Congress Nicholas Florko What’s included? Washington Correspondent Nicholas Florko reports on the the intersection of politics and health policy. He is the author the newsletter “D.C. Diagnosis.” [email protected] WASHINGTON — It’s arguably the most cutting-edge and potentially lucrative area of biomedical science and now, to protect their investments, companies commercializing CRISPR genome editing technology are looking to shore up their Washington bonafides.But unlike their comrades in the conventional drug world, CRISPR lobbyists aren’t blitzing every office on Capitol Hill with a slate of pro-industry proposals. The goal is more understated: to make sure the companies with experimental treatments just now entering the clinic are unimpeded by government bureaucracies. @NicholasFlorko Tags CongressCRISPRSTAT+last_img read more

Cardinal Health is fined by Ohio for failing to secure shipments of controlled substances

first_img STAT+ is STAT’s premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond. GET STARTED @Pharmalot What is it? What’s included? Tags opioidspharmaceuticalsSTAT+ Pharmalot Columnist, Senior Writer Ed covers the pharmaceutical industry. Unlock this article by subscribing to STAT+ and enjoy your first 30 days free! GET STARTED Pharmalot Concerned about the diversion of opioids, the Ohio Board of Pharmacy has fined Cardinal Health (CAH), one of the largest pharmaceutical wholesalers in the U.S., $5,000 for failing to secure shipments of controlled substances.A board spokesman explained that the small penalty reflected limits of $2,500 per violation, but that the board took the infraction seriously. “We want all controlled substances secured and not subject to diversion,” he told us. “And want to make sure that Cardinal Health has policies and procedures in place to prevent that problem.center_img Ed Silverman Log In | Learn More [email protected] About the Author Reprints Cardinal Health is fined by Ohio for failing to secure shipments of controlled substances Patrick Sison/AP 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. By Ed Silverman April 8, 2019 Reprintslast_img read more

Doctors discover telehealth’s silver lining in the Covid-19 crisis

first_img [email protected] By Rujuta Saksena April 19, 2020 Reprints First OpinionDoctors discover telehealth’s silver lining in the Covid-19 crisis Seeing our patients in their pajamas.We can work in pajamas, too.Finally “meeting” the dogs and cats they talk so much about.Gently reminding them about social distancing as their grandkids play on their laps.Feeling amazed after a successful FaceTime visit with an 89-year-old.Getting magnified views of chin hair, moles, nostrils, and other facial features of patients who aren’t fully familiar with the cameras on their phones or computers.Conversing about their home décor and choice of wall color.Realizing that it’s now acceptable to enjoy a cup of coffee with our patients.Actually seeing ourselves as we chat, and fixing our hair or smiles in response to the image in the video window.iPads are now a legitimate business expense.Having far fewer test results to review since patients aren’t coming to the lab for tests.If laughter is indeed the best medicine, and if this sampling of anecdotes is any indication, my colleagues doing telehealth are quite healthy:“I just spent an entire televisit looking at a patient’s ear canal.” — an oncologist in New Jersey.“I find it rather difficult to do pelvic exams with virtual visits.” — a gynecologist in Atlanta.“I thought virtual visits were going well until my patient decided to show me his hemorrhoids.” — a gastroenterologist in New Jersey.To be fair, this optimistic view of telemedicine must be balanced against its downsides, including the inability to do physical examinations, which can affect patient care; the inability to obtain essential blood work; the inability to console patients when giving bad news; and more. To get through the time of Covid-19 with as little PTSD as possible, physicians need to keep their rose-colored glasses on, at least now and then. Related: About the Author Reprints During virtual visits with patients, when I hear their children crying or see their dogs on their laps, a certain friendship develops that otherwise wouldn’t have incubated in an office setting. As a colleague, Dr. Bonnie Guerin, told me, “It’s just a different vibe.”For some of us, our arranged marriages to telemedicine might morph into love. If Gabriel García Márquez were still alive, he might have called these silver linings “Love in the time of corona.”Rujuta Saksena, M.D., is a hematology and oncology specialist in Summit, New Jersey. Telehealth has many advantages, including keeping patients safe from possible exposure to the coronavirus that causes Covid-19, improving access to care, cutting health care costs, and contributing toward a greener earth by cutting down on car trips to see doctors in their offices. It also offers its own type of personal and lighthearted or even heart-warming connections.Over the past few weeks, I have had conversations with several colleagues about this new wrinkle in our professional lives. Here are some of the things we enjoy about telemedicine in the time of Covid-19:advertisement Across the U.S., thousands of doctors like Dr. Michael Murphy in Springfield, Ill., now see their patients via virtual visits to reduce the chance of spreading the coronavirus that causes Covid-19. Rujuta Saksena Before the Covid-19 crisis, I — like most physicians — thought that in person, face-to-face encounters afforded me the greatest level of connection and intimacy with my patients. Yet many of us have been pleasantly surprised to discover the perks of telehealth during the unprecedented coronavirus crisis.Centuries of doctor-patient relations have centered on in-person communication and physical examination. We have been conditioned to view that as the norm, causing us to see telehealth as disembodied and impersonal, making us reluctant to embrace it.Then came the Covid-19 ambush. With mandated social distancing policies in place to counter the rapid spread of a highly infective virus, health care providers have been forced into an overnight arranged marriage with telemedicine. For some of us, there is the potential for true love.advertisement Surge in patients overwhelms telehealth services amid coronavirus pandemic Tags patientsphysicianstelehealthlast_img read more

Decades of basic research paved the way for today’s ‘warp speed’ Covid-19 vaccines

first_img Ian A. Wilson A cadre of researchers with critically important knowledge of this virus family was able to guide the scientific community in how to respond to the Covid-19 pandemic.Many of the technologies now used widely for vaccine design are rooted in longstanding programs to fight HIV and influenza. For various reasons that relate to the properties of the viruses themselves, those pathogens are much more difficult to vaccinate against than SARS-CoV-2, but the accrued knowledge of how to counter them has been invaluable.The recently approved monoclonal antibody Covid-19 therapies from Eli Lilly and Regeneron also benefitted greatly from the techniques used to identify and produce similar antibodies for HIV clinical trials and also led to the antibody cocktails that were used to treat people infected with Ebola virus.When Chinese scientists published the SARS-CoV-2 genome sequence on the internet on Jan. 10, 2020, multiple vaccine programs were started within days because existing vaccine design methods could be repurposed.All of the leading vaccines are based on the SARS-CoV-2 spike protein, the entity on the virus surface that drives infection of human cells. Humans infected with SAR-CoV-2 raise antibodies against the spike-protein that prevent further infection by neutralizing the virus.The various vaccines present the spike protein to the immune systems in different way but with a common purpose: triggering the immune system to produce antibodies that neutralize the virus as soon as it is encountered, thereby preventing or limiting the infection.Decades of work, first on the corresponding HIV spike protein and then its counterparts from other viruses, including SARS, MERS, and seasonal coronaviruses, showed how best to design and produce the SARS-CoV-2 version. Sophisticated methods to image the spike proteins via recent advances in electron microscopy allowed researchers and vaccine makers rapidly to study what they were making, gaining assurances that they were on the right track.The Pfizer/BioNTech and Moderna/NIH vaccines deliver the spike protein in the form of mRNA. This technology emerged during the past decade from university laboratories working on HIV and influenza vaccines, which then triggered Zika, Ebola, and coronavirus vaccine programs at the NIH and in the pharmaceutical industry. The Moderna mRNA vaccine, in particular, was made as a collaboration with the NIH’s Vaccine Research Center, funded by U.S. taxpayers since 1997 to create vaccines against deadly viruses and other human diseases. A method developed by Janssen, a pharmaceutical company, to present spike proteins to the immune system also emerged from an HIV vaccine program at Harvard University. AstraZeneca’s version of the adenovirus delivery system has a similar history. Decades of work on the corresponding HIV and influenza proteins, as well as coronavirus proteins, underpin the Novavax SARS-CoV-2 spike protein vaccine design. DNA vaccines are also in clinical trials, another method derived from research on HIV and other viral pathogens. John P. Moore [email protected] In the U.S. alone, the National Institutes of Health provides approximately $4 billion dollars a year to immunology and vaccine research programs, with further substantial support from private funders such as the Bill and Melinda Gates Foundation. These multiyear, multimillion dollar investments in basic science provided the foundation from which the new vaccines rapidly emerged. About the Authors Reprints Related: [email protected] The Covid-19 vaccines are a marvel of science. Here’s how we can make the best use of them Related:center_img Tags CoronavirusVaccines The emergency use authorizations of mRNA vaccines by Pfizer/BioNTech and Moderna and the likely gradual rollout of multiple others is our collective best hope for curtailing the Covid-19 pandemic.The speed at which these vaccines has been developed is remarkable, both in absolute terms and compared to the multiyear time frame it normally takes to create and approve new vaccines. Great credit is due to the pharmaceutical industry and the university and government scientists who have worked directly and diligently on Covid-19 vaccine programs in the U.S., Europe, and elsewhere. They deserve accolades for their skillful hard work.But the Covid-19 vaccines did not come from nowhere. Decades of research by tens of thousands of scientists worldwide put in place the essential knowledge and methods that underpinned their rapid development.advertisement Some of the vaccine trials have been conducted by the pharmaceutical industry. However, an extensive network of trial sites funded by the NIH for HIV vaccine clinical research is playing a key role. Fundamental immunology research programs in U.S. universities developed the techniques to study how humans respond both to viruses like SARS-CoV-2 and the vaccines that counter them. Existing methods only needed to be adjusted for the new virus. Comparisons to immune responses in infected people will be essential for understanding how the Covid-19 vaccines perform in the longer term.U.S. taxpayers are spending approximately $18 billion dollars on the production and distribution of Covid-19 vaccines via Operation Warp Speed. That effort would not have been possible without the prior expenditure of much smaller sums on basic immunology and vaccinology research. As two researchers who have spent many years working on viral pathogens, we believe that this funding has been very well-spent.Funding scientific research is buying an insurance policy for a better future. The benefits are not always apparent, and sometimes become visible only over many years. 2020 is a case in point: The nation’s existing research infrastructure laid the groundwork for Covid-19 vaccines to be designed within weeks of the emergence of a deadly virus and produced within months.We cannot know when the next global health crisis will hit, but we do know that continuing to support medical science is essential for a rapid and effective response when it does.John P. Moore is a professor of microbiology and immunology at Weill Cornell Medicine in New York City. Ian A. Wilson is professor and chair of the Department of Integrative Structural and Computational Biology at the Scripps Research Institute in La Jolla, Calif. A researcher works on a Covid-19 vaccine at the University of Copenhagen in Denmark. THIBAULT SAVARY/AFP via Getty Images By John P. Moore and Ian A. Wilson Jan. 5, 2021 Reprints First OpinionDecades of basic research paved the way for today’s ‘warp speed’ Covid-19 vaccines Watch: mRNA vaccines face their first test in the fight against Covid-19. How do they work? SARS-CoV-2, the virus that causes Covid-19, is a coronavirus. Research over the past two decades on the earlier severe acute respiratory syndrome (SARS) virus and its cousin, the virus that causes Middle East respiratory syndrome (MERS), taught virologists and vaccine designers a great deal about coronaviruses, their vulnerabilities, and how they might best be exploited.advertisementlast_img read more