First Edition: November 27, 2018
Today's early morning highlights from the major news organizations.
Kaiser Health News:
One Twin’s Difficult Birth Puts A Project Designed To Reduce C-Sections To The Test
The tiny hand and forearm slipped out too early. Babies are not delivered shoulder first. Dr. Terri Marino, an obstetrician in the Boston area who specializes in high-risk deliveries, tucked it back inside the boy’s mother. “He was trying to shake my hand and I was like, ‘I’m not having this — put your hand back in there,'” Marino would say later, after all 5 pounds, 1 ounce of the baby lay wailing under a heating lamp.This is the story of how that baby, Bryce McDougall, tested the best efforts of more than a dozen medical staffers at South Shore Hospital in Weymouth, Mass., that day last summer. (Bebinger, 11/27)
The New York Times:
Trump Moves To Lower Medicare Drug Costs By Relaxing Some Patient Protections
The Trump administration proposed on Monday to cut costs for Medicare by reducing the number of prescription drugs that must be made available to people with cancer, AIDS, depression, schizophrenia and certain other conditions. Under the proposal, health insurance plans that provide drug coverage to Medicare beneficiaries would no longer have to cover all of the drugs in six “protected classes.” The change would take effect in 2020 and would lead to lower out-of-pocket costs for Medicare beneficiaries, the administration said. (Pear, 11/26)
The Hill:
Trump Administration Looks To Give Private Medicare Plans Negotiating Power On Drugs
Currently, private Medicare health plans are required to cover all or “substantially all” drug in six “protected” classes, such as HIV treatments, antidepressants and cancer drugs, regardless of cost. This gives pharmaceutical companies little incentive to make the drugs affordable, administration officials said. “The lack of any ability for Part D plans to manage drugs in the protected classes has allowed the pharmaceutical industry to command high prices on protected class drugs in Part D, without patients getting a good deal,” Centers for Medicare and Medicaid Services Administrator Seema Verma said in a statement. (Weixel, 11/26)
The Associated Press:
Proposed Changes On Medicare Drugs Create Winners And Losers
Verma said the changes, if finalized, would ultimately save money for beneficiaries by sharpening competition among the insurers who deliver Medicare Advantage and prescription coverage. "At the end of the day, the patient remains in the driver's seat," she said. "They decide which plan to pick." (Alonso-Zaldivar, 11/26)
Stat:
HHS Proposes Letting Private Medicare Plans Exclude New Types Of Drugs
It was the first in a series of changes that the Trump administration put forth in a new regulation late on Monday, all of which largely nibble around the edges of the underlying problem of high drug prices. Each of the polices are nonetheless likely to inflame drug companies and allied patient advocates who have said similar policy proposals could limit patient access to medicines. Under current law, private Medicare drug plans are required to cover “all or substantially all” drugs in six classes: 1) antidepressants; 2) antipsychotics; 3) anticonvulsants; 4) immunosuppressants for treatment of transplant rejection; 5) antiretrovirals; and 6) antineoplastics. The original intent was to make sure insurers did not deny vulnerable patients access to potentially life-saving drugs. (Florko, 11/26)
Stat:
Trump Team Takes Aim At Pharmacy Fees In Complex New Proposal
The Trump administration wants to tweak Medicare rules to lower patients’ out-of-pocket costs at the pharmacy counter. It sounds simple, but the policy proposal it outlined on Monday is anything but. The actual idea takes aim at the fees some pharmacies pay to some drug makers as part of their contracts with insurance companies or pharmacy benefit managers. It’s separate from the administration’s other hints at changing Medicare “rebates” that flow from drug makers to PBMs to negotiate favorable treatment on a drug formulary. (Florko, 11/26)
Politico:
Watchdog Office To Probe Mar-A-Lago Members' Influence At VA
The Government Accountability Office will investigate whether members of Mar-a-Lago, President Donald Trump’s private club in Palm Beach, Florida, improperly influenced the Department of Veterans Affairs, including over a $10 billion contract to modernize veterans’ health records, according to a letter from the watchdog office released by Democratic lawmakers Monday. Sens. Elizabeth Warren (D-Mass.) and Brian Schatz (D-Hawaii) had requested an investigation in August following reports that Trump confidant Ike Perlmutter, chairman of Marvel Entertainment, and Bruce Moskowitz, a West Palm Beach doctor, used their access to the club — and the president — to delay and shape a plan to overhaul digital health records at the VA. (Woellert, 11/26)
The Associated Press:
Audit: Iowa Medicaid Savings Barely Half What Was Projected
Iowa saved $126 million this year from privatizing its Medicaid system, barely half what former Gov. Terry Branstad projected when he forced the change in 2016, according to an audit released Monday. The report by Auditor Mary Mosiman also found officials and lawmakers have failed to file quarterly financial reports as required by state law. (Pitt, 11/26)
The Associated Press:
Virginia Submits Medicaid Work Requirement Proposal To Feds
Virginia has submitted its proposed work requirement plan for some Medicaid recipients to the federal government for approval. Department of Medical Assistance Services Director Jennifer Lee told lawmakers Monday that the state submitted its proposal to the federal Centers for Medicare & Medicaid Services last week. Virginia lawmakers voted to expand eligibility for the publicly funded health care program earlier this year that also included work requirement and copay provisions for certain newly eligible recipients. (11/27)
The New York Times:
Chinese Scientist Claims To Use Crispr To Make First Genetically Edited Babies
Ever since scientists created the powerful gene editing technique Crispr, they have braced apprehensively for the day when it would be used to create a genetically altered human being. Many nations banned such work, fearing it could be misused to alter everything from eye color to I.Q. Now, the moment they feared may have come. On Monday, a scientist in China announced that he had created the world’s first genetically edited babies, twin girls who were born this month. (Kolata, Wee, and Belluck, 11/26)
Los Angeles Times:
Why Geneticists Say It's Wrong To Edit The DNA Of Embryos To Protect Them Against HIV
The ethical debate over “designer babies” has focused on using gene-editing to select such traits as eye color, intelligence or athletic prowess. But He focused on another trait that is highly prized in China: resistance to HIV. He had recruited seven couples in which the prospective father was HIV-positive and the mother was not. The couples were offered free fertility treatments and the chance to have a gene called CCR5 disabled in their embryos. The edit was made when the woman’s eggs were fertilized with her husband’s sperm in a laboratory dish. Of 22 embryos created, 16 got the experimental treatment. Eleven of those embryos were implanted into six women before the twin pregnancy was achieved, He told the Associated Press. (Healy, 11/26)
NPR:
Chinese Researcher Used CRISPR To Edit Embryonic DNA Of Twin Girls
He is now facing investigation by a local medical ethics board to see whether his experiment broke Chinese laws or regulations. The university where He worked issued a statement that officials were "deeply shocked" by the experiment, which it stressed was conducted elsewhere. He, the statement says, has been on unpaid leave from the university. (Stein, 11/26)
Stat:
What We Know — And Don’t — About Claim Of The First Gene-Edited Babies
No one knows exactly how He Jiankui, on leave from Southern University of Science and Technology in Shenzhen, did it. Scientists gathered in Hong Kong at an international summit on human genome editing will have to wait until Wednesday to hear He describe his work in more detail. Here’s what we do know. (Cooney, 11/26)
Reuters:
More Than 100 Scientists In China Say Baby Gene Editing Is 'Crazy'
More than 100 scientists, most of them in China, have condemned as "crazy" and unethical altering human genes after a geneticist claimed he had changed the genes of twin girls to create the first gene-edited babies. In an open letter circulating online, the scientists said the use of CRISPR-Cas9 technology to edit the genes of human embryos was risky, unjustified and harmed the reputation and development of the biomedical community in China. (11/27)
The Associated Press:
Q&A On Scientist's Bombshell Claim Of Gene-Edited Babies
There is wide scientific agreement that rewriting DNA before birth — to prevent an inherited disease or to give a baby some "designer" trait — isn't yet safe to try outside laboratory experiments that do not lead to human births. "Grossly premature and deeply unethical," is how noted U.S. bioethicist Henry Greely of Stanford University characterized the claim. (Neergaard and Ritter, 11/26)
The Washington Post:
Chinese Scientist’s Claim Of Gene-Edited Babies Creates Uproar
The unverified claim by He came on the eve of an international summit dedicated to discussing the emerging science and ethics around powerful tools that give scientists unprecedented potential to tweak traits and eliminate genetic diseases — but that have raised fears of “designer babies.” By editing the DNA of human embryos, scientists change not just the genes in a single person, but also their potential offspring — in effect, altering the human species. (Johnson, 11/26)
Stat:
An Outsider Claimed Genome-Editing History; The World Snapped To Attention
“I am trying to understand what may have motivated the work he describes,” said a scientist who helped organize a major Hong Kong summit on human genome editing that starts Tuesday and who asked not to be named. “As far as I can tell, it was a combination of hubris, naivete, and perhaps a genuine desire to help people in need. He does not seem to have anticipated the profound public backlash against his work and the way it was conducted and publicized.” He clearly knew the attention that his announcement would get. He reportedly worked with an American public relations specialist; gave advance interviews to the Associated Press, which has a global reach; timed the big reveal to the start of the summit; and posted a series of YouTube videos in English celebrating the achievement. (Joseph, Robbins and Begley, 11/26)
Stat:
Rice Opens Investigation Into Researcher Who Worked On CRISPR'd Babies
Rice University said Monday that it had opened a “full investigation” into the involvement of one of its faculty members in a study that purportedly resulted in the creation of the world’s first babies born with edited DNA. Michael Deem, a bioengineering professor at Rice, told the Associated Press in a story published Sunday that he helped work on the research in China. (Joseph, 11/26)
The Associated Press Fact Check:
Obama Didn't Have Family Separation Policy
President Donald Trump is falsely asserting that the federal policy that split migrant families at the border was practiced by his predecessor, Barack Obama, as well. The Obama and Trump administrations operated under the same immigration laws but the "zero tolerance" policy that drove children from their parents was Trump's. (Woodward, 11/27)
The New York Times:
Only Romaine Lettuce From Central And Northern California Is Unsafe, F.D.A. Says
It’s O.K. to eat romaine lettuce again, federal health officials said on Monday — as long as you’re sure it wasn’t grown on California’s north and central coast. The Food and Drug Administration and the Centers for Disease Control and Prevention said investigators had traced the romaine lettuce associated with an outbreak of E. coli that has sickened 65 people in 12 states and Canada to “end of summer” romaine lettuce harvested from that region. (Kaplan, 11/26)
The Associated Press:
US Officials: It’s OK To Eat Some Romaine, Look For Labels
People shouldn’t eat romaine that doesn’t have the label information, the FDA said. For romaine that doesn’t come in packaging, grocers and retailers are being asked to post the information by the register. Romaine harvesting recently began shifting from California’s Central Coast to winter growing areas, primarily Arizona, Florida, Mexico and California’s Imperial Valley. Those winter regions weren’t yet shipping when the illnesses began. The FDA also noted hydroponically grown romaine and romaine grown in greenhouses aren’t implicated in the outbreak. (Choi, 11/26)
The Washington Post:
Only Romaine Lettuce From Certain Parts Of Calif. Should Be Avoided, FDA Says In New Warning
The new warning from the FDA and the Centers for Disease Control and Prevention came as the number of people sickened by the outbreak grew to 43 people in 12 states. Sixteen of those people have been hospitalized, including one person with severe kidney failure. No deaths have been reported. The updated information follows an unusually broad warning that federal health officials issued two days before Thanksgiving, telling consumers to throw away any romaine lettuce they may already have purchased. (Sun, 11/26)
The Wall Street Journal:
Regulators Tie Tainted Romaine Lettuce To California
The current E. coli outbreak is the third linked to leafy greens within the past year. The FDA said 11 more people had been sickened in the outbreak, bringing the total to 43 people in 12 states. Sixteen people have been hospitalized, and one has developed a form of kidney failure, according to the CDC. Twenty-two people have also fallen ill in Canada, and officials in that country have advised people in Ontario, Quebec and New Brunswick to avoid eating the lettuce. (Newman, 11/26)
The Associated Press:
FDA Says It Will Overhaul Criticized Medical Device System
U.S. health officials said Monday they plan to overhaul the nation's decades-old system for approving most medical devices, which has long been criticized by experts for failing to catch problems with risky implants and related products. The Food and Drug Administration announced plans aimed at making sure new medical devices reflect up-to-date safety and effectiveness features. The system targeted by the actions generally allows manufacturers to launch new products based on similarities to decades-old products, not new clinical testing in patients. (Perrone, 11/26)
The Wall Street Journal:
FDA Is Revamping Clearance Procedures For Medical Devices
“It’s time to fundamentally modernize an approach first adopted in 1976, when Congress considered the vast diversity of devices” entering the U.S. market, senior FDA officials said in a statement disclosed Monday. The officials are FDA Commissioner Scott Gottlieb and Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health. Drs. Gottlieb and Shuren said the agency plans to drive companies “toward reliance on more modern predicate devices or objective performance criteria.” Their plan is to shift companies, if they continue with the use of predicate devices, toward those no older than 10 years rather than the 40-year precedents now. (Burton, 11/26)
The Associated Press:
Improving Medical Device Tracking A Slow, Imperfect Process
For nearly two decades, health advocates have pushed to standardize the way medical devices are tracked and studied. They eventually landed on a solution that others, including other parts of the medical industry, already had adopted — a unique code to help track the type, manufacturer and other key information about a device. In 2007, Congress asked the U.S. Food and Drug Administration to create the system, and the FDA passed a final rule establishing it in 2013. (Hoyer, 11/26)
The Associated Press:
Breast Implants Reveal Problems In Tracking Device Safety
To all the world, it looked like breast implants were safe. From 2008 to 2015, the U.S. Food and Drug Administration publicly reported 200 or so complaints annually — a tiny fraction of the hundreds of thousands of implant surgeries performed each year. Then last fall, something strange happened: Thousands of problems with breast implants flooded the FDA's system. More than 4,000 injury reports filed in the last half of 2017. Another 8,000 in the first six months of 2018. (Hoyer, 11/26)
The Associated Press:
CVS, Aetna Draw Closer To Closing $69B Combination
Shares of CVS Health and Aetna are rising with the companies now saying they expect to close their $69 billion tie-up later this week. The companies say in regulatory filings that they have the final regulatory approval needed and expect to close on or around Wednesday. CVS Health Corp. had told investors earlier this month that it expected to close the deal for the nation's third-largest health insurer before Thanksgiving. But its shares slipped last week after the drugstore chain and pharmacy benefit manager said it still lacked approval from two states. (11/26)
The Wall Street Journal:
CVS Health Secures Final Approval For $70 Billion Aetna Deal
On Monday, the New York State Department of Financial Services announced it would approve the deal after CVS and Aetna Health Insurance Co. of New York agreed to a range of consumer protections and said they would spend $40 million on health insurance education measures. CVS said in a securities filing Monday it may complete the deal on Nov. 28. A CVS spokeswoman confirmed the company now has all state-level permissions for the merger in place. (Maidenberg, 11/26)
Stat:
America's Scattershot Medical Records Could Frustrate Promise Of ‘Big Data’
Doctors, researchers, and companies have made big promises about how machine learning and AI may someday change medicine. But a particularly American issue may be holding doctors and data scientists here back: electronic medical records. Machine learning algorithms only work if they have data — lots and lots of data. The conclusions they draw about what might happen to a particular person will generally only work if an algorithm has been trained with a bunch of records of people who have some similar characteristics. And especially in the traditional “doctor’s office,” companies that want to work on AI and machine learning must somehow pull in information from a plethora of EMRs — a burden not often seen in other countries. (Sheridan, 11/27)
The Washington Post:
FDA Approves ‘Precision Medicine’ Drug For Different Cancers With Same Mutation
The Food and Drug Administration on Monday approved a drug for a wide range of cancers based on a shared mutation, rather than the tumors' locations — an advance for the sometimes controversial field of “precision medicine.” The medication, called Vitrakvi, is the second treatment to receive FDA clearance based on a common biomarker found in an array of cancers. The drug, also called larotrectinib, was approved simultaneously for adults and children. Typically, oncology drugs are considered much later for children. (McGinley, 11/26)
Stat:
Loxo Oncology's Cancer Drug Wins A Pioneering FDA Approval
The drug, larotrectinib, is designed to kill off tumors by attacking a protein called TRK, which becomes hyperactive in people with certain genetic mutations. Whereas nearly all cancer drugs are approved to fight malignancies in the lung, breast, or pancreas, Loxo’s therapy is cleared for any advanced cancer that expresses TRK, making it the first drug developed as a tumor-agnostic treatment, according to the FDA. (Garde, 11/26)
NPR:
China Pours Money Into Research, Luring U.S. Scientists And Students
In 2003, Jay Siegel was up for a new challenge. Siegel was a tenured professor of chemistry at the University of California, San Diego, but he took a job at the University of Zurich. "When I first moved, people said, 'Oh, you're crazy to leave San Diego; it's a paradise. Why would you go to Europe? Blah, blah blah,' "recalls Siegel. "And after 10 years people were saying, 'Oh, man, that was the smartest thing you ever did. Zurich is wonderful.' " (Palca, 11/27)
NPR:
Catholic Hospitals Restrict Doctors From Moonlighting As Abortion Providers
Doctors who are opposed to abortions don't have to provide them. Since the 1970s, a series of federal rules have provided clinicians with "conscience protections" that help them keep their jobs if they don't want to perform or assist with the procedure. Religious hospitals are also protected. Catholic health care systems, for example, are protected if they choose not to provide abortions or sterilizations. Doctors who work for religious hospitals usually sign contracts that they'll uphold religious values in their work. (Gordon, 11/26)
The New York Times:
How Pollution Can Hurt The Health Of The Economy
One argument for rolling back environmental regulations — as is occurring under the Trump administration — is that a lighter touch on industry will lift investment and economic growth. But increased pollution can also have long-term negative economic consequences. The effects on health are bad enough on their own, and are well understood. ... Less well understood is how this can affect things like educational and economic outcomes. Many studies, some focused on regions of the United States, others on cities elsewhere, have documented this kind of relationship: It’s harder to perform well at work or school if you don’t feel well. Additionally, if school performance suffers as a result of health problems, that threatens long-term work and earnings prospects. (Frakt, 11/27)
The Wall Street Journal:
A Lab Tests Playing To Help Children With Autism
Otis Grimm is squealing with joy as he swings, lying belly-down in a blue net swing, trying to reach the ladder before him. The 7-year-old’s goal: to pull himself up a few rungs and grab a bean bag from the bucket dangling enticingly above him. This isn’t gymnastics class or a playground—it’s a therapy session. Otis is part of a study at Albert Einstein College of Medicine/Montefiore Health System where researchers are testing two autism therapies and how they affect the brain. “The bean bags are all the way up there. How are you going to go up there?” Tim Conly, a senior occupational therapist at Montefiore, asks Otis. (Reddy, 11/26)
The New York Times:
Probiotics Do Not Ease Stomach Flu
Probiotics, the beneficial bacteria that live in our digestive tracts, are widely used to treat gastroenteritis or “stomach flu,” an inflammation of the stomach and intestines usually caused by a virus or bacterium. But a randomized clinical trial has found that the treatment is ineffective. Researchers studied 971 children 3 months to 4 years old who arrived in emergency rooms with the typical symptoms of gastroenteritis — nausea, vomiting, watery diarrhea and dehydration, stomach pain and cramps. They were randomly assigned to a five-day course of Lactobacillus rhamnosus, a commonly studied probiotic, or a placebo. (Bakalar, 11/26)
The Washington Post:
Your Imagination Could Help Conquer Your Fears
Therapists often use a technique that involves exposing patients to the source of their fears to conquer them, but a new study suggests that guided imagining of the source of fear can be just as effective. The traditional method, called threat extinction, relies on triggering areas of the brain involved in perception, memory, learning and imagination, and the authors of the new study show the same processes occur when the fear source is “simulated” by imagining it. (Carroll, 11/27)
The New York Times:
Cancer Pushes New York’s ‘First Girlfriend,’ Sandra Lee, Onto Political Stage
She strolled slowly through the neighborhood, a down-to-earth sprawl of sun-blasted ranch houses, and Sandra Lee was in her element. In contrast to her high-gloss public persona, Ms. Lee wore a simple, loose-fitting dress, no makeup, the only thing adorning her face a pair of oversized sunglasses. Still, she could not contain her inner rah-rah: Whenever a jogger passed, she stopped to cheer them on. And then she resumed the conversation, back to the art of the undersell. (McKinley, 11/27)