First Edition: March 7, 2019

Kaiser Health News: Medical Device Makers Report Malfunctions And Patient Injuries In FDA Database Hidden From Public View
Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up. Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and “there was nothing,” he said. Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. Such failures can have deadly consequences. (Jewett, 3/7)

Kaiser Health News: A Mumps Quarantine In La. May Encroach On Rights Of Detained Immigrants
A mumps outbreak and quarantine at the Pine Prairie Immigration and Customs Enforcement Processing Center in Louisiana blocked immigrants from legal resources, including their lawyers and the law library, for about two weeks in January and February, according to the attorneys. The outbreak has also raised questions about how officials dealing with public health concerns can undermine detainees’ legal rights. Lawyers said the illness did not stop immigration court proceedings — meaning from at least Feb. 3 to Feb. 14 quarantined individuals were required to continue with removal hearings, conducted from their dorm rooms via video chat, while not receiving access to legal aid. (Luthra and Appleby, 3/6)

The Wall Street Journal: Trump Administration Looks To Jump Start Interstate Health-Insurance Sales
The Trump administration is weighing new ways to spur the sale of health insurance across state lines, a long-held goal of President Trump and congressional Republicans that has so far failed to gain much traction. The Centers for Medicare and Medicaid Services on Wednesday asked for comment on eliminating regulatory and other barriers that may be discouraging interstate sales, a request that often means guidance or new regulation will follow. “Americans are in desperate need of more affordable health insurance options,” said CMS Administrator Seema Verma in a statement. She that eliminating barriers to selling insurance coverage across state lines “could help provide access to a more competitive and affordable health insurance market.” (Armour, 3/6)

Modern Healthcare: Reinsurance Faces Partisan Hurdles In Key House Hearing
A proposal to fund a $10 billion-per-year reinsurance pool for state Obamacare markets hit partisan gridlock in a U.S. House of Representatives hearing Wednesday. Representatives in the House Energy and Commerce Committee's health panel clashed over adding anti-abortion language to the reinsurance bill and disagreed over the proposal's scope. It's a significant request from the insurance industry this year, and now faces a tough road ahead. (Luthi, 3/6)

The New York Times: Senate Confirms Trump Nominee Who As Justice Official Fought The Affordable Care Act
The Senate on Wednesday confirmed Chad A. Readler of Ohio as President Trump’s 33rd federal appeals court judge despite bipartisan criticism that as a Justice Department official in the Trump administration he had shirked his official responsibility to defend the Affordable Care Act when it was challenged in court. Mr. Readler’s nomination is just the latest to divide the Senate as Republicans renew their drive to fill federal district and circuit court vacancies while gearing up to force through a Senate rules change to accelerate the confirmation process for the remainder of Mr. Trump’s tenure. (Hulse, 3/6)

The New York Times: The Imposing Venture Of 3 Corporate Giants Gets A Not-So-Imposing New Name
We can finally put a name to the thing striking fear within the health care establishment: Haven. The secretive new venture, created by corporate titans Amazon, Berkshire Hathaway and JPMorgan Chase to transform health care for their employees, has gone without an official name for more than a year. It was nameless when a well known doctor was appointed last summer to run it. It was referred to only as ABC or ABJ in a recent lawsuit brought by giant health insurer UnitedHealth Group, which described whatever-it-was as a powerful potential competitor. (The venture would only say it had no current plans to compete, and a federal judge ruled against UnitedHealth.) (Abelson, 3/6)

Reuters: Amazon, Berkshire, JPMorgan Healthcare Company To Be Called Haven
The three companies announced plans for a new venture in January of 2018, shaking the shares of health insurance companies like UnitedHealth Group Inc and Cigna Corp that manage large corporate benefits on worries that Amazon would disrupt the traditional insurance and drug benefit businesses. Haven Chief Executive Atul Gawande, who has been running the company since July, said in a news release that the company plans to start small and expand. (3/6)

Stat: The Atul Gawande Company Finally Has A Name: Haven 
“We will create new solutions and work to change systems, technologies, contracts, policy, and whatever else is in the way of better health care,” Dr. Atul Gawande, the company’s chief executive, wrote in a letter posted on the website. “We will be relentless. We will insure our work has high impact and is sustainable.” (Ross, 3/6)

The Wall Street Journal: Health Venture Of Amazon, Berkshire, JPMorgan Has A Name: Haven
The website reiterates that Haven isn’t meant to generate profits and will “reinvest any surplus back into our work.” The company says it will focus on priorities including improved access to primary care, simplifying insurance coverage and making prescription drugs more affordable—all issues that were previously highlighted in court testimony. In a Q&A on the site, in answer to a question about whether Haven will look to replace patients’ existing doctors and insurance companies, the company says it is “interested in working with clinicians and insurance companies to improve the overall health care system.” (Wilde Mathews, 3/6)

The New York Times: Good News: Opioid Prescribing Fell. The Bad? Pain Patients Suffer, Doctors Say.
Three years ago this month, as alarms about the over-prescription of opioid painkillers were sounding across the country, the federal government issued course-correcting guidelines for primary care doctors. Prescriptions have fallen notably since then, and the Trump administration is pushing for them to drop by another third by 2021. But in a letter to be sent to the Centers for Disease Control and Prevention on Wednesday, more than 300 medical experts, including three former White House drug czars, contend that the guidelines are harming one group of vulnerable patients: those with severe chronic pain, who may have been taking high doses of opioids for years without becoming addicted. (Hoffman and Goodnough, 3/6)

The Washington Post: Health-Care Providers Say CDC’s Opioid Guidelines Are Harming Pain Patients
The health-care providers, including three former U.S. drug czars, said the CDC recommendation of a daily numerical threshold for opioid use has led insurers to refuse reimbursement, pharmacies to erect obstacles to obtaining drugs and risks for doctors who want to give out more. “Taken in combination, these actions have led many health care providers to perceive a significant category of vulnerable patients as institutional and professional liabilities to be contained or eliminated, rather than as people needing care,” they said in a letter to the agency. (Bernstein, 3/6)

The Associated Press: Political Feud Complicates Kentucky's Fight Against Opioids
For every 100,000 people in Kentucky, 23 are killed by opioid overdoses — nearly double the national rate. But a political feud is complicating the state's effort to hold drug companies accountable for their part in the epidemic. Democratic Attorney General Andy Beshear and Republican Gov. Matt Bevin are fighting over Beshear's attempt to hire private attorneys to battle the drug companies. Beshear is running for governor, and Bevin is the man he could face in the general election. (Beam, 3/6)

Bloomberg: Sackler Family Faces Art World Protests With Purdue Under Siege
The family behind Purdue Pharma LP, the OxyContin maker facing billions of dollars in potential liabilities for its role in the U.S. opioid epidemic, has been under siege for months in the art world. The Sackler brothers Arthur, Mortimer and Raymond, who transformed closely held Purdue into a pharmaceutical giant, were benefactors of some of the world’s most prominent museums, including the Smithsonian Institution, New York’s Metropolitan Museum of Art and the U.K.’s National Gallery. (Kazakina and Stupples, 3/6)

Stat: With Gottlieb’s Resignation, The Trump Administration Loses Its Backroom Whisperer On Capitol Hill
The Trump administration just lost its most effective health policy salesman. Scott Gottlieb, the charismatic FDA commissioner who announced this week he will step down in about a month, was better than any other administration official at selling key Trump administration policies — particularly those related to lowering prescription drug prices — on Capitol Hill, lawmakers and aides in both parties told STAT. (Florko and Facher, 3/6)

The Hill: Departing FDA Chief Says Youth Vaping Crackdown Will Continue 
Outgoing Food and Drug Administration (FDA) Commissioner Scott Gottlieb said his departure won't have any impact on the agency's crackdown on youth vaping. "I'm very confident of that, and I'm very confident that we're going to continue with this policy over the next month, including the policy that we've been formulating," Gottlieb said during an event hosted by The Hill Wednesday. (Hellmann, 3/6)

Politico: FDA Moves On Vaping, Drugs And Food At Risk With Chief’s Departure
Gottlieb's initiatives on nutrition and vaping, along with overhauling regulation of dietary supplements, often were at odds with Republican orthodoxy and the Trump administration's anti-regulatory zeal. That means whoever replaces the 46-year-old libertarian physician will be hard pressed to get buy-in from the HHS Secretary, the White House and both parties in Congress. "We've developed very firm administrative records to support what we're doing and the other thing is, we built consensus," Gottlieb told POLITICO in an interview. "We did the hard work to get political consensus, not just broadly across Capitol Hill but within the administration. We went through the hard process of policymaking and we did it in an open and transparent fashion." (Karlin-Smith, Owermohle and Bottemiller Evich, 3/6)

The Hill: FDA Chief's Resignation Casts Cloud Over Vaping Crackdown
“He is leaving at a uniquely sensitive time,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids. “If his departure means the promises he’s made don’t get adopted, then literally an entire generation of kids is at risk.” (Hellmann, 3/6)

Stat: The Likely, Possible, And Longshot Contenders To Replace Gottlieb At FDA
The sudden resignation of Scott Gottlieb, the commissioner of the Food and Drug Administration, leaves a giant hole atop an agency that oversees a quarter of the U.S. economy. Which, of course, leads to an equally big question: Who will replace him? This is actually a two-part question. First, the administration will likely decide on an acting commissioner, who can take control when Gottlieb departs in a month. Then comes the harder task of finding a nominee who can be confirmed by the Senate. (3/7)

ProPublica: Senators Demand Investigation Into Sexual Abuse at Immigrant Children’s Shelters
Sens. Charles Grassley, R-Iowa, and Dianne Feinstein, D-Calif., called on Wednesday for a federal investigation into what they termed “the alleged widespread and long-term pattern of sexual abuse” in the facilities holding immigrant children. In a letter to the U.S. Department of Health and Human Services Inspector General’s Office, the senators said they were particularly concerned that allegations of sexual assault aren’t being properly investigated. (Grabell and Sanders, 3/6)

The Hill: Feinstein, Grassley Call For Investigation Into Minor Sexual Abuse At HHS Facilities
We respectfully request that you open an investigation into the alleged widespread and long-term pattern of sexual abuse against unaccompanied children in HHS facilities and reports that these cases of sexual assault are not being appropriately investigated," the senators wrote in a letter to Inspector General Daniel Levinson. (Frazin, 3/6)

ProPublica: Trump Mar-A-Lago Buddy Wrote Policy Pitch. The President Sent It to VA Chief.
In late 2017, on one of President Donald Trump’s retreats to Mar-a-Lago, his private club in Palm Beach, Florida, he caught up with an old friend: Albert Hazzouri. When Hazzouri is not at Mar-a-Lago, he’s a cosmetic dentist in Scranton, Pennsylvania. At a campaign rally there in 2016, Trump gave him a shoutout: “Stand up, Albert. Where the hell are you, Albert? Stand up, Albert. He’s a good golfer, but I’m actually a better golfer than him. Right?” Shortly after Hazzouri and Trump saw each other in late 2017, Hazzouri followed up with a message, scrawled on Mar-a-Lago stationery. (Arnsdorf, 3/6)

The Associated Press: 'Jeopardy!' Host Alex Trebek Says He Has Pancreatic Cancer
"Jeopardy!" host Alex Trebek said he has been diagnosed with advanced pancreatic cancer but intends to fight the disease and keep on working. In a video posted online Wednesday, the 78-year-old said he was announcing his illness directly to "Jeopardy!" fans in keeping with his long-time policy of being "open and transparent." (Elber, 3/6)

The Washington Post: ‘Jeopardy!’ Host Alex Trebek Diagnosed With Pancreatic Cancer
“Just like 50,000 other people in the United States each year, this week I was diagnosed with Stage 4 pancreatic cancer,” he said. “Now, normally, the prognosis for this is not very encouraging, but I’m going to fight this, and I’m going to keep working, and with the love and support of my family and friends — and with the help of your prayers, also — I plan to beat the low survival-rate statistics for this disease. Truth told, I have to. Because under the terms of my contract, I have to host ‘Jeopardy!’ for three more years.” (Rao, 3/6)

Los Angeles Times: ‘Jeopardy!’ Host Alex Trebek Says He Has Stage 4 Pancreatic Cancer And Vows To Fight It
According to the American Cancer Society, more than 56,000 people in the U.S. will be diagnosed with pancreatic cancer this year, and about 45,000 of them will die from the often-terminal illness. Trebek’s Stage 4 diagnosis means that the cancer has advanced and spread to other parts of his body. (Saad, 3/6)

Stat: The Mysterious Dark Money Group Behind A Pharma-Bashing Ad Campaign
A new dark money group with conservative ties has run more than $100,000 worth of Facebook ads bashing pharmaceutical companies and high drug prices since October, STAT has learned. Their spokesperson is a well-known Republican communications professional who previously worked for President Trump’s Department of Health and Human Services. And their biggest promoter is the conservative radio talk show host Hugh Hewitt, who has mentioned the group multiple times on his morning show. (Swetlitz, 3/7)

Stat: Allergan’s Would-Be Antidepressant Fails Patients In Four Studies
In 2015, Allergan spent $560 million on Naurex, a small biotechnology company that had what appeared to be an important new treatment for depression. Brent Saunders, Allergan’s CEO, called the deal “a compelling and exciting investment,” and said it could help in the most severe, treatment-resistant cases of depression. Not so fast. On Wednesday evening, Allergan announced the disappointing news that the lead drug from the deal, rapastinel, had failed to improve depression symptoms more than placebo when added to existing antidepressants in not one but three studies. (Herper, 3/6)

Reuters: Fitbit Launches Lower-Cost Fitness Devices To Combat Samsung, Apple
Fitbit Inc launched its cheapest smartwatch on Wednesday to defend its position as the second-largest seller of smartwatches after Apple Inc. San Francisco-based Fitbit said the Versa Lite smartwatch will cost $160, down from $200 for the full version. While still tracking workouts and heart rate, it will lack some features such as the ability to store music directly on the watch. In 2018, Fitbit sold 5.5 million smartwatches, behind the biggest seller Apple Inc's 22.5 million units, but just ahead of Samsung's 5.3 million units, according to data firm Strategy Analytics. (3/6)

The New York Times: W.H.O. Chief Plans To Reorganize A Vast Bureaucracy
The World Health Organization on Wednesday announced a long-awaited restructuring intended to streamline the agency — and strongly hinted that it intended to shake up some staffers’ resistance to change. The announcement, made in a lengthy and mostly cheerful speech delivered jointly by the organization’s director general, Tedros Adhanom Ghebreyesus, and the directors of the agency’s six regional offices, aims to serve the W.H.O.’s new targets: to get affordable health care to the world’s poorest 1 billion people; to better protect them against epidemics; and to help them enjoy better health, including protection from noncommunicable diseases like cancer. (McNeil, 3/6)

Reuters: WHO Chief Unveils Reforms, With More Science, Apps And An Academy
His back-to-basics approach won fervent support among health ministers, partly reflecting the WHO's failure in 2014 to seize on what became the world's worst Ebola outbreak, and the fact that many of the 11,300 deaths in that outbreak would have been prevented by better primary healthcare in West Africa. Announcing the reforms, Tedros told WHO staff that UHC is the "WHO's top priority, and is central to everything we do". (UHC). (3/6)

The Washington Post: Long Overlooked By Science, Pregnancy Is Finally Getting Attention It Deserves
For two years, a group of world-class scientists pitched their idea for a hot new biotech company to investors: a start-up focused on a promising therapy for preeclampsia, a serious pregnancy complication that can become life-threatening. It was cutting-edge science, backed by a Nobel laureate, a Harvard kidney specialist, a leading chemist, and a biologist with both expertise and personal experience. Eventually, they gave up — not on the science, and not on preeclampsia — but on the investors. (Johnson, 3/6)

Reuters: New Mothers Suffer Nerves, Guilt As Maternity Leave Ends
Many new mothers worldwide express anxiety and guilt about leaving their babies to return to work, and some worry their nations' maternity policies reflect societies that value productivity over raising children. In a series of interviews for Reuters ahead of International Women's Day on March 8, mothers from the United States to Uruguay to South Africa to Singapore told of their concerns about stopping work to give birth and look after their newborns. (3/6)

The Wall Street Journal: For Teens, A Push For Confidential Medical Advice
When Hannah Regan was about 14 years old, her family doctor in Kentucky started a new routine. During checkups, the doctor would ask Hannah’s mother to briefly step out of the exam room. Then, in private, Hannah would discuss a questionnaire she filled out about smoking, drinking, mental health and other sensitive issues. There were awkward moments, she says, but she appreciated the time alone with her doctor. “I think it was beneficial to allow the doctor-patient relationship to be something the teen can trust in,” says Ms. Regan, now 23. (Abbott, 3/6)

The New York Times: A Heart-Healthy Diet May Be Good For The Brain
Eating a heart-healthy diet beginning in your 20s may provide brain benefits in middle age, new research suggests. The study, in Neurology, ranked 2,621 people on their degree of adherence to three different diets considered to be good for the heart. All emphasize vegetables, fruits and whole grains and minimize saturated fat consumption: the Mediterranean diet, which involves mainly plant-based foods and moderate alcohol intake; a research-based diet plan that rates food groups as favorable or not; and the DASH diet, which stresses low-sodium foods. (Bakalar, 3/6)

Los Angeles Times: Two Patients With HIV Are In Remission. How Many More Will Follow Them?
And then there were two. A London man infected with HIV has gone into long-term remission after getting a special stem cell transplant that not only treated his cancer, it sent the virus into remission as well. His recovery, described this week in the journal Nature, marks the second time a patient has cleared HIV from his system with the help of a stem cell transplant. (Healy, 3/6)

The Washington Post: Dog-Walking Can Be Hazardous For Seniors, Study Suggests
Dogs need to go on walks, and walking is good exercise for older adults. Seniors who combine the two — by walking a dog — are healthier than people who don’t, according to some research. But a new study by University of Pennsylvania researchers offers a cautionary note. Strolling with a leashed dog, it says, “imparts a significant and rising injury risk in older adults.” Between 2004 and 2017, it found, bone fractures associated with walking leashed dogs more than doubled among U.S. residents 65 and older. Nearly 8 in 10 who suffered fractures were women, and the most commonly broken bones were hips, wrists and upper arms. (Brulliard, 3/6)

The Associated Press: Lawmakers: High Costs Slowing Action On Contaminant In Water
Cleaning up and protecting U.S. drinking water from a class of toxic chemicals used in many household items could cost in the tens of billions of dollars nationally, including $2 billion for the Department of Defense alone, witnesses testified Wednesday before a House panel urging the federal government to move more quickly on the cleanup. Rep. Harley Rouda, the California Democrat chairing the House Oversight and Reform environment subcommittee, told reporters after the hearing "it's clear" the high costs were slowing any federal efforts to regulate and clean up the toxic chemicals, which are found in a range of goods, including nonstick pans, stain-resistant clothing, dental floss and food containers. (3/6)

The Washington Post: Alabama Judge Allows Man To Sue Clinic On Behalf Of Aborted Fetus
An Alabama judge has recognized the legal rights of an aborted fetus, allowing a man whose girlfriend ended her pregnancy at six weeks to sue the manufacturer of the pill she used and the clinic that gave it to her. The decree, issued by Madison County Probate Judge Frank Barger, explicitly states “Baby Roe” is a person and allows plaintiff Ryan Magers to name the fetus as a co-plaintiff in the suit for “wrongful death.” Magers said in court filings that when his then-girlfriend discovered she was pregnant in early 2017, he “repeatedly pleaded” with her to carry the pregnancy to term and give birth, but she wanted to have an abortion. (Cha and Thibodeaux, 3/6)

The Associated Press: Georgia House Panel Approves Anti-Abortion 'Heartbeat' Bill
Amid tears, gasps and handshakes, a Georgia House committee approved legislation Wednesday to outlaw abortion after a fetus' heartbeat can be detected, which is before many women know they are pregnant. Women in Georgia can currently seek an abortion up to 20 weeks of a pregnancy. A heartbeat is generally detectable by medical professionals at around 6 weeks. (3/6)

Chicago Tribune: New Illinois Bill Would Boost Punishment For Understaffed Nursing Homes To Limit Deadly Sepsis Infections And Boost Care
A state lawmaker and a major advocacy group are pushing stiffer penalties for short-staffed nursing homes as a way to limit deadly sepsis infections and boost overall care. “You would think that anytime you put your loved one in a nursing home, the care would be there, because it’s supposed to be regulated, but we find that’s not the case,” said state Sen. Jacqueline Collins, D-Chicago, who introduced reform legislation this week. Collins and AARP Illinois are supporting the legislation partly in response to the findings of an investigation published in September by Kaiser Health News and the Chicago Tribune. The investigation found that about 6,000 Illinois nursing home patients a year who were hospitalized had sepsis, with roughly 1 in 5 dying. (Mahr, 3/6)

The Washington Post: House To Vote Thursday On Allowing Lethal Dose Of Drugs For Terminal Patients
A bill that would allow terminally ill patients to legally obtain a lethal dose of medicine to end their lives advanced in the Maryland House of Delegates on Wednesday, setting the stage for what will likely be a dramatic vote on Thursday. It is the first time — after three attempts in recent years — that the legislation will be debated on the floor of the General Assembly. The bill moved forward without any discussion, even though it has both strong support and strong opposition in the Democratic-majority House to make Maryland the seventh state to allow patients to get help in ending their own lives. (Wiggins, 3/6)

Los Angeles Times: L.A. Settles Homeless Rights Case, Likely Limiting Ability To Clear Skid Row Streets
The Los Angeles City Council on Wednesday agreed to settle a pivotal and contentious case on the property rights of homeless people — a decision that is likely to limit the seizure and destruction of encampments on skid row. The 10-2 vote authorizes City Attorney Mike Feuer to settle a 2016 lawsuit, Carl Mitchell v. Los Angeles, brought by civil rights lawyers on behalf of homeless people and two skid row anti-poverty groups. Downtown business groups had opposed such a deal, arguing that settling the case would deter redevelopment, and leave skid row and the people who live on its sidewalks mired in squalor. (Holland, 3/6)