First Edition: December 3, 2018
Today's early morning highlights from the major news organizations.
Kaiser Health News:
Government Investigation Finds Flaws In The FDA’s Orphan Drug Program
The Government Accountability Office, which spent more than a year investigating the FDA’s orphan drug program, said “challenges continue” in the program that was created to spur development of drugs for diseases afflicting fewer than 200,000 patients. The investigation began after a request from three high-profile Republican senators last year, in the wake of a KHN investigation. KHN found that the program was being manipulated by drugmakers to maximize profits and to protect niche markets for medicines being taken by millions. (Tribble and Lupkin, 11/30)
Kaiser Health News:
Medicare Cuts Payments To Nursing Homes Whose Patients Keep Ending Up In Hospital
The federal government has taken a new step to reduce avoidable hospital readmissions of nursing home patients by lowering a year’s worth of payments to nearly 11,000 nursing homes. It gave bonuses to nearly 4,000 others. These financial incentives, determined by each home’s readmission rates, significantly expand Medicare’s effort to pay medical providers based on the quality of care instead of just the number or condition of their patients. Until now, Medicare limited these kinds of incentives mostly to hospitals, which have gotten used to facing financial repercussions if too many of their patients are readmitted, suffer infections or other injuries, or die. (Rau, 11/3)
Kaiser Health News:
Feds Order More Weekend Inspections Of Nursing Homes To Catch Understaffing
The federal government announced plans Friday to crack down on nursing homes with abnormally low weekend staffing by requiring more surprise inspections be done on Saturdays and Sundays. The federal Centers for Medicare & Medicaid Services said it will identify nursing homes for which payroll records indicate low weekend staffing or that they operate without a registered nurse. Medicare will instruct state inspectors to focus on those potential violations during visits. (Rau, 11/30)
The New York Times:
Trump Administration Peppers Inboxes With Plugs For Private Medicare Plans
Older Americans have been flocking to Medicare’s private plans, which promise predictable costs and extra benefits. But the private Medicare Advantage plans have also been getting an unpublicized boost from the Trump administration, which has in the last few weeks extolled the virtues of the private plans in emails sent to millions of beneficiaries. (Pear, 12/1)
The Hill:
Ocasio-Cortez Says ‘Death Panels’ Exist In Private Health Insurance Market
Rep.-elect Alexandria Ocasio-Cortez (D-N.Y.) on Sunday referred to "death panels," which was popularized almost a decade ago by Sarah Palin, saying they exist in the private health insurance market. "Actually, we have for-profit 'death panels' now: they are companies + boards saying you’re on your own bc they won’t cover a critical procedure or medicine," she wrote in a back-and-forth with the president of a conservative think tank on Twitter. (Keller, 12/2)
The Hill:
Ocasio-Cortez: 'Frustrating' That Lawmakers Oppose 'Medicare For All' While Enjoying Cheap Government Insurance
Incoming Rep. Alexandria Ocasio-Cortez (D-N.Y.) tweeted Saturday that she was frustrated to learn that her health-care costs would be chopped by more than half upon entering Congress, accusing her fellow lawmakers of enjoying cheap government health insurance while opposing similar coverage for all Americans. In a tweet, the New York freshman lawmaker-elect wrote that her health care as a waitress was "more than TWICE" as high as what she would pay upon taking office as a congresswoman next month. (Bowden, 12/1)
Politico:
GOP Lawmakers’ Reality: They Won’t Cut Planned Parenthood
Congressional Republicans are giving up on years of promises to cut federal funding for Planned Parenthood as Democrats prepare to take control of the House, a major setback for the conservative movement after controlling both chambers of Congress and the White House for the past two years. The futility of the congressional efforts was clear as the lame-duck session of Congress convened this week and Sen. Ted Cruz (R-Texas) briefly tried — and failed — to rally support for one last bid to push through Planned Parenthood cuts, Obamacare repeal and other conservative priorities. But most Republicans, already rattled by the possibility of a shutdown next week triggered by President Donald Trump’s border wall demands, dismissed his bid. (Ollstein, 12/2)
Stat:
FDA Fails To Assess Important Needed Info For Orphan Status, Report Finds
As more drug makers race to win orphan designations, a new report finds the Food and Drug Administration fails to consistently record and evaluate needed information, which suggests the agency may not always include critical data for granting the coveted orphan status. Specifically, the FDA granted the designation to 26 applications that were missing required information, such as verified estimated patient populations, and 102 of 148 so-called review templates were missing background information. Moreover, FDA guidance was not always clear in instructing agency staff on how to use the recorded information, according to the U.S. Government Accountability Office. (Silverman, 11/30)
Stat:
As Amazon Moves Into The Pharmacy Business, Licensing Efforts Gain Scrutiny
As Amazon attempts to muscle its way into the health care market, one requirement for this octopus of a company is to obtain various licenses in states around the U.S. in order to market devices and medicines. But over the past year, a series of gaffes underscore the scrutiny Amazon faces as it looks to disrupt a crucial market that company executives have targeted as a key growth area. The most recent instance involves PillPack, which mails prescriptions to people who take multiple medicines and which Amazon recently acquired for $1 billion. Earlier this year, PillPack sought a pharmacy license in New Mexico, but an initial attempt was denied on Nov. 2 due to incomplete information, according to an official with the New Mexico Board of Pharmacy. (Silverman, 11/30)
Stat:
BIO CEO Greenwood Talks Drug Pricing Politics After The Midterms
BIO CEO Jim Greenwood won’t admit last month’s midterm elections spell trouble for the drug industry. Despite Democrats taking control of the House of Representatives, floating splashy legislation and openly threatening to investigate drug companies, Greenwood says that come January, he’s going to march into Democrat’s offices and unapologetically sing the praises of the drug industry. (Florko, 12/3)
Stat:
Unbowed By Critics, Gilead's Cancer Chief Pushes Ahead With Growth Plans
Gilead Sciences has spent years and billions of dollars to build out its oncology business, most notably by acquiring the cancer cell therapy developer Kite Pharma for $12 billion in 2017. But all that investment, which now includes the approved CAR-T treatment called Yescarta, has yet to deliver commercially. Yescarta sales are growing each quarter (now totaling $175 million year to date), but the product barely makes a dent in Gilead’s overall income statement. By acquiring Kite, Gilead became a leader in cell therapy but it has no presence in the larger and more lucrative immuno-oncology market where Merck, Roche, and Bristol-Myers Squibb dominate. (Feuerstein, 12/2)
Stat:
Gene Therapy 'Switch' For Sickle Cell Disease Shows Encouraging Results In Pilot
The results of this gene therapy clinical trial, being reported Saturday for the first time at the American Society of Hematology annual meeting, are preliminary but encouraging. For the past six months, Johnson hasn’t required blood transfusions. He’s symptom-free. And when doctors peer into his blood, they see no evidence of the damaged, crescent-shaped red blood cells that give sickle cell disease its name. (Feuerstein, 12/1)
Stat:
Benefit Of Blood Disease Drug From Acceleron And Celgene Debated By Experts
The benefit for patients treated by an experimental blood disease drug from Acceleron Pharma and licensed to Celgene was further clarified and debated by experts Saturday at a press conference during the American Society of Hematology annual meeting. The Acceleron drug, called luspatercept, is widely expected to secure approval late next year based on results from two separate Phase 3 clinical trials demonstrating statistically significant reductions in the need for blood transfusions. The patients enrolled in these two studies were diagnosed with myelodysplastic syndrome, a cancer-like disease of the bone marrow, and beta-thalassemia, a rare inherited disorder that reduces the production of oxygen-carrying hemoglobin. (Feuerstein, 12/1)
The New York Times:
He’s Built An Empire, With Detained Migrant Children As The Bricks
Juan Sanchez grew up along the Mexican border in a two-bedroom house so crowded with children that he didn’t have a bed. But he fought his way to another life. He earned three degrees, including a doctorate in education from Harvard, before starting a nonprofit in his Texas hometown. Mr. Sanchez has built an empire on the back of a crisis. His organization, Southwest Key Programs, now houses more migrant children than any other in the nation. Casting himself as a social-justice warrior, he calls himself El Presidente, a title inscribed outside his office and on the government contracts that helped make him rich. (Barker, Kulish and Ruiz, 12/2)
The Wall Street Journal:
Employers Change Tactics To Curb Health-Insurance Costs
Company leaders are grappling with how to deal with the rising cost of health insurance in ways that get beyond the longtime strategy of simply passing on more of the burden to workers. “The CEOs of our clients are more involved in the health-care benefits program than I’ve seen in 25 years,” says Jim Winkler, a senior vice president at consulting firm Aon PLC. “It’s, ‘What are we spending our money on, and does it make sense?’ ” (Wilde Mathews, 12/2)
The Associated Press:
Could Anyone Have Stopped Gene-Edited Babies Experiment?
Early last year, a little-known Chinese researcher turned up at an elite meeting in Berkeley, California, where scientists and ethicists were discussing a technology that had shaken the field to its core — an emerging tool for "editing" genes, the strings of DNA that form the blueprint of life. The young scientist, He Jiankui, saw the power of this tool, called CRISPR, to transform not only genes, but also his own career. (Marchione and Larson, 12/2)
Stat:
The CRISPR’d Baby Controversy Shook Science, But Not Wall Street
This week’s announcement that two Chinese children were born with CRISPR-modified genes exploded onto the global stage. Experts joined Good Morning America and took to Twitter, sharing their fears for the future and for the children’s health and discussing their concerns about the ethical quandaries realized sooner than some had expected. Wall Street, however, was unfazed. Share prices for three publicly traded companies using CRISPR — Editas, Intellia and CRISPR Therapeutics — haven’t faltered. If anything, most CRISPR-based stocks have become more valuable since the announcement. Editas’s and CRISPR Therapeutics’ share prices rose about 15 percent over the course of the week; Intellia’s was up by about 4 percent. (Sheridan, 11/30)
The New York Times:
Genetically Modified People Are Walking Among Us
It felt as if humanity had crossed an important line: In China, a scientist named He Jiankui announced on Monday that twins had been born in November with a gene that he had edited when they were embryos. But in some ways this news is not new at all. A few genetically modified people already walk among us. In the mid-1990s, fertility doctors in New Jersey got an idea for how to help women have children. They suspected that some women struggled to become pregnant because of defective material in their eggs. (Zimmer, 12/1)
The Washington Post:
‘Gene Drive’ Research To Fight Diseases Can Proceed Cautiously, U.N. Group Decides
Scientists hoping to fight diseases with genetically engineered organisms that spread their genes in the wild will be able to proceed cautiously under an agreement reached this week. That was the compromise outcome of a protracted debate, conducted in Egypt at a major U.N. conference on biodiversity, over a technology known as “gene drives.” A gene drive is a form of genetic engineering that seeks to push modified genes through a population. The Bill and Melinda Gates Foundation has funded a program called Target Malaria that envisions using a gene drive to combat the mosquitoes that carry malaria, a disease that kills nearly half a million people a year. (Achenbach, 11/30)
The Washington Post:
Migraine Treatments Offer New Ways Of Relief
Nancy Baum Lipsitz remembers the night the pain began. She’d had a glass of white wine with a friend and went to bed with a terrible headache. The next day, she still felt horrible, the beginning of what she called a “rolling tide” of near constant migraines and lower level headaches. For three years she dealt with the symptoms. Sometimes she got tunnel vision, or a visual aura, a warning that a big headache was on the way. Those felt like “someone taking a pick and jabbing it through my nose and eye,” she said. (Vander Schaaff, 12/1)
The Washington Post:
Some Tips For Avoiding Migraines During The Holidays.
The biggest problem with the holidays season for migraine sufferers is falling out of a regular routine, said Charles Flippen II, clinical professor of neurology at David Geffen School of Medicine at UCLA. Flippen, a fellow of the American Academy of Neurology, offers some tips for managing the season. (Vander Schaaff, 12/1)
The Washington Post:
Another Diplomat Was Diagnosed With ‘Havana Syndrome.’ Here’s What We Know.
Last week, another Canadian diplomat was diagnosed with a mysterious disease so weird it’s been referred to in some circles as “the thing.” The illness afflicts only government employees from the United States and Canada. Sufferers report feeling pulsing or hearing a ringing in their ears. Then headaches, dizziness, trouble concentrating and struggles to remember basic words and facts. (Erickson, 12/3)
The Washington Post:
Cancer Treatment May Be Less Aggressive If You're Not Part Of A Couple.
If you are divorced, widowed or never married and develop cancer, watch out. You may get less aggressive treatment than your married friends. We’ve often heard about studies showing that married adults are more likely to survive cancer than singles. But buried in those same studies is another finding that hasn’t made the headlines. When surgery or radiotherapy is the treatment of choice, patients with spouses are more likely to get it. (DelFattore, 12/1)
The New York Times:
The Placenta, An Afterthought No Longer
The placenta may be dismissed as “afterbirth,” deemed an afterthought in discussions about pregnancy and even relegated, literally, to the trash bin. But at long last it is beginning to get its due. In the past three weeks, scientists have published three significant studies of this ephemeral organ. One gave a detailed analysis of all the genes expressed, or converted into functioning proteins, in the placenta; another experimented with a way to silence that expression when it causes trouble. In the third, researchers created mini-placentas, three-dimensional clusters of cells, or organoids, that mimic the real thing in the lab, and can be used as models for studying it. (Mandavilli, 12/3)
Los Angeles Times:
Holiday Gift Advice From Pediatricians: Skip The Electronic Toys And Go With The Classics
The holiday shopping season is underway, and the nation’s pediatricians have some advice for the parents, grandparents, aunts, uncles and others who plan to buy cutting-edge digital toys for the young children in their lives: Don’t do it. Sure, these toys may promise to boost a little one’s brain development, or to give them a head start in school. They may come in packages that feature endorsements from “experts.” In all likelihood, they come with a price tag that implies they are of great value. (Kaplan, 12/3)
The New York Times:
Why Are Taxi Drivers In New York Killing Themselves?
A taxi driver named Roy Kim recently became the eighth professional driver to die by suicide in New York over the last year. The city’s taxi commissioner, Meera Joshi, has characterized the deaths as an epidemic. The stories have drawn attention to the economic despair in the industry and prompted the City Council to weigh new legislation to help taxi owners reduce their debt and to increase driver wages. (Fitzsimmons, 12/2)
The Washington Post:
Friendship Is Important To Well-Being, Especially During The Holidays
For many of us, especially those without family nearby, spending time with friends can be a meaningful way to celebrate the holidays. As fewer people opt for marriage, friendships have become more than social relationships: Friends are proxy families, and they may be better than the real ones. Researchers have found that these personal connections may be more beneficial to one’s health and well-being than family relationships. And at a time when loneliness has become a public health crisis with young adults saying they feel lonelier than older generations, studies show that investing in friendships pays off. According to the Mayo Clinic, these bonds can help reduce stress, increase happiness and bolster self-confidence. (Fraga, 12/2)
USA Today:
For Asians, Blacks, Latinos, Genealogical Tests Don't Tell Full Story
Family history DNA tests are pegged to be hugely popular gifts this Christmas – but are they worth it if you're one of the 30 percent or so of Americans with ancestors who didn't come from Europe? Today, the answer is a qualified maybe. People of color generally aren't going to get the same specificity of ethnicity estimates as white Americans, though the results are slowly getting more precise for those with ancestors from Africa, Asia and the Americas. Even so, experts suggest collecting DNA from your oldest relatives now, wherever they come from, because one day it's going to be a genealogical gold mine. (Weise, 12/2)
The New York Times:
Loss And Bravery: Intimate Snapshots From The First Decade Of The AIDS Crisis
When the World Health Organization declared Dec. 1 World AIDS Day in 1988, the disease was already a global pandemic. By the end of that year, 82,362 cases of AIDS had been reported in the United States, and more than 61,000 people had died nationwide. In the 30 years since, the disease has killed an estimated 35.4 million people in all, including more than 700,000 in the United States. Today, there are still some 36.9 million people living with H.I.V. and AIDS around the world. The war is far from over in the United States. If current trends continue, half of all black gay and bisexual men will be living with HIV during their lifetimes. The epidemic is hitting hardest in the South, the region of our country with the fewest resources to combat it. (12/1)
The New York Times:
Why Hospitals Should Let You Sleep
If part of a hospital stay is to recover from a procedure or illness, why is it so hard to get any rest? There is more noise and light than is conducive for sleep. And nurses and others visit frequently to give medications, take vitals, draw blood or perform tests and checkups — in many cases waking patients to do so. (Frakt, 12/3)
The Associated Press:
Clinic 1st In Virginia To Treat Opioid-Addicted Moms-To-Be
A Charlottesville clinic has become the first in the state to offer a treatment program specifically for pregnant women trying to break opioid addictions before they give birth. “We were realizing that as the dependent population continued to grow, that the pregnant and addicted population would grow along with that,” said Dr. Christopher von Elten, a co-founder of Addiction Allies. “We kept asking why no one was addressing it, and we decided we would.” Many doctors and clinics are hesitant to offer medications to pregnant women addicted to opioids, said von Elten said, and it can be burdensome for providers to navigate necessary regulations. (Smith, 11/30)
The Washington Post:
Isolation And Loneliness May Contribute To Addiction
Feeling lonely? Social isolation isn’t just bad for your mood — it can be bad for your health, too. And in a TEDxMidAtlantic talk, Rachel Wurzman says it contributes to opioid addiction — fueling drug use, relapses and overdoses. Wurzman, a neuroscientist, says she thinks there is a way to make recovery from opioid addiction easier: social connection. That idea is informed by her work with the striatum, a region at the base of the forebrain that helps enable decision-making and is dramatically affected by social connection. (Blakemore, 12/1)
NPR:
Brain Changes Seen After A Single Season Of Youth Football
A single season playing football might be all it takes to change a young athlete's brain. Those are the preliminary findings of research presented this week in Chicago at the annual meeting of the Radiological Society of North America. Researchers used special MRI methods to look at nerve bundles in the brain in a study of the brains of 26 young male football players, average age 12, before and after one season. Twenty-six more young males who didn't play football also got MRI scans at the same time to be used as a control group. (Westerman, 11/30)
NPR:
Docs Say Kids With Concussions Don't Have To Stay In The Dark For Days
A couple of weeks ago, eight-year-old Liam Ramsay-Leavitt of Martinez, Calif., was swinging on the monkey bars at school. "And then I just fell on my side," he says. "I was kind of dizzy and I had an achy head." It turns out that he had a concussion. (Singh, 12/3)
The New York Times:
‘From Nothing To Gangbusters’: A Treatment For Sickle-Cell Disease Proves Effective In Africa
A drug that protects children in wealthy countries against painful and sometimes lethal bouts of sickle-cell disease has been proven safe for use in Africa, where the condition is far more common, scientists reported on Saturday. More research remains to be done, experts said, but knowing that hydroxyurea — a cheap, effective and easy-to-take pill — can safely be given to African children may save millions of youngsters from agonizing pain and early deaths. (McNeil, 12/1)
CNN:
Polio Cases No Longer Declining; WHO Fears Future Resurgence
Progress has stalled in ridding the world of polio. An emergency committee of the World Health Organization unanimously agreed Friday to continue to designate the paralyzing disease a "Public Health Emergency of International Concern." WHO originally designated polio in this way in 2014, deeming it a health threat serious enough to endanger communities worldwide. This year, WHO has recorded 27 cases of wild poliovirus worldwide, compared with 22 total cases last year. Though the small number of cases may appear insignificant, the committee said the trend is noteworthy because it shows stagnation. (Scutti, 11/30)
The Associated Press:
Assaults Surge At Washington Mental Hospital
The tall, lanky patient walked out of his room at Washington state's largest psychiatric hospital and spit on two patients before ducking back inside. A few minutes later, he came back out and punched two patients, so Larry Herbert, a licensed practical nurse, went after the man. As Herbert approached, the patient punched him in the face. Herbert wrapped his arms around the patient, and they wrestled until another worker joined in and they all hit the floor. Herbert's knee went "snap, snap" as his body twisted in one direction then the other. He ended up in surgery with three torn ligaments and has spent the past six months on the couch, unsure when or if he can return to work. (12/3)
The Washington Post:
This High School Was Rocked By An HIV Scare 10 Years Ago
Ten years ago, Jennifer Wyms was a 17-year-old junior at Normandy High School in Wellston, Mo. She was the captain of her school’s hip-hop dance team and enjoyed going to the mall with friends. But when a health scare engulfed her St. Louis community, it cast a shadow on her high school experience. A letter from school officials sent to parents and guardians in October 2008 relayed the news that epidemiologists with the St. Louis County Department of Health had grounds to believe that HIV may have been transmitted among some students — as many as 50 students at Normandy High School could have been exposed, it said. “Everybody wanted to know, who had it? Where it came from? Why our school?” Wyms told The Washington Post. (Ferguson, 11/30)
CNN:
This Town Is Like Thousands That Are Vulnerable To Contaminated Water, With No Fix In Sight
Virginia Tech engineering Professor Marc Edwards watched as water flowed from a garden hose in Enterprise, Louisiana. As he moved a jar to catch a sample, the color changed from clear to brown. "When mine comes out, it comes out black," Enterprise resident John Tiser said as he watched Edwards work. Tiser, Enterprise's newly appointed water board president, was giving Edwards a tour around this rural community in central Louisiana, where residents have struggled with water problems. He says his wife drives 20 miles each direction to do laundry in a town with clear water. (Ganim, 11/28)
USA Today:
Camp Fire: The List Of Missing People Drops To 25
More than three weeks after the Camp Fire began ravaging Northern California, the Butte County Sheriff announced Saturday the number of unaccounted for has dropped to 25 people. The lift of missing has fluctuated since the fire began on Nov. 8, reaching a high of 1,276 people on Nov. 17. The missing list began at 35, returning to double digits for the first time Friday when it shrunk from 196 to 49. (Lam, 12/2)