- KFF Health News Original Stories 4
- Unused Johnson & Johnson Covid Doses Are Piling Up as FDA Waits to See if Shelf Life Can Be Extended
- Women Now Drink as Much as Men — And Are Prone to Sickness Sooner
- Zooming Into the Statehouse: Nursing Home Residents Use New Digital Skills to Push for Changes
- An Anti-Vaccine Film Targeted to Black Americans Spreads False Information
- Political Cartoon: 'The Ultimate Incentive?'
- Vaccines 3
- Officials Rush To Save Or Use Millions Of J&J Doses Expiring This Month
- Biden's July 4 Vaccine Goal May Be At Risk Thanks To Gen Z's Hesitancy
- Pfizer Trial Using Lower-Dose Vaccine In 5- To 11-Year-Olds
- Covid-19 3
- Fauci Raises Alarm Over Spread Of Delta Covid Variant
- When Did Covid Really Hit The US? GOP Lawmakers Ask CDC To Study
- US Lowers Travel Risk Warnings To Dozens Of Nations
- Administration News 2
- Biden Shuts Down Infrastructure Negotiations With Republicans
- White House Wants To Shore Up Made-In-America Prescription Drug Pipeline
From KFF Health News - Latest Stories:
KFF Health News Original Stories
Unused Johnson & Johnson Covid Doses Are Piling Up as FDA Waits to See if Shelf Life Can Be Extended
As vaccine expiration dates loom, states with hundreds of thousands of doses on hand say demand is tanking and there’s no easy way to donate to other states or countries that might want them (Rachana Pradhan and Christina Jewett, 6/8)
Women Now Drink as Much as Men — And Are Prone to Sickness Sooner
Young women have closed the gender gap for excessive drinking. And that was before the pandemic. The trend is particularly troubling because women are at greater risk for blackouts, liver disease, cardiovascular diseases and certain cancers linked to alcohol use. (Aneri Pattani, 6/9)
Zooming Into the Statehouse: Nursing Home Residents Use New Digital Skills to Push for Changes
Connecticut residents who learned how to communicate with family and friends through digital technology when their nursing homes closed to visitors last year used that skill to testify remotely during legislative hearings on bills affecting them. (Susan Jaffe, 6/9)
An Anti-Vaccine Film Targeted to Black Americans Spreads False Information
A new movie produced by Robert F. Kennedy Jr.'s anti-vaccine group tries to capitalize on the covid-19 pandemic, the racial justice movement and renewed interest in the history of medical racism. (Will Stone, 6/9)
Political Cartoon: 'The Ultimate Incentive?'
KFF Health News provides a fresh take on health policy developments with "Political Cartoon: 'The Ultimate Incentive?'" by Mike Luckovich.
Here's today's health policy haiku:
FACEBOOK CHANGES ITS TUNE ON COVID
Suggest lab as source
and get your account banned; now,
even prez says it
- Anonymous
If you have a health policy haiku to share, please Contact Us and let us know if we can include your name. Haikus follow the format of 5-7-5 syllables. We give extra brownie points if you link back to an original story.
Opinions expressed in haikus and cartoons are solely the author's and do not reflect the opinions of KFF Health News or KFF.
Have your eye on Big Sky Country? KHN is set to launch HealthWeek 406, a new weekly newsletter dedicated to Montana health news. It will feature KHN stories as well as curated stories from trusted news sources. Sign up now for the free email.
Summaries Of The News:
Officials Rush To Save Or Use Millions Of J&J Doses Expiring This Month
As the FDA investigates extending expiration dates, vaccine administrators get mixed messages on what to do with Johnson & Johnson covid vaccines that are closing in on expiry. Efforts to ship the unused doses overseas also face hurdles.
The Wall Street Journal:
Millions Of J&J Covid-19 Vaccines Are At Risk Of Expiring In June
Hospitals, state health departments and the federal government are racing to decide how to use up millions of Johnson & Johnson’s Covid-19 vaccine doses that are set to expire this month. The prospect of so many doses going to waste in the U.S. when developing nations are desperate for shots would add pressure on the Biden administration to share stockpiled vaccines. But there are few practical solutions to administering them quickly in the U.S. or distributing them in time to foreign countries, according to those involved in the vaccination drive. (Hopkins and Wernau, 6/8)
KHN:
Unused Johnson & Johnson Covid Doses Are Piling Up As FDA Waits To See If Shelf Life Can Be Extended
The Biden administration is encouraging states to hold on to hundreds of thousands of soon-to-expire covid vaccine doses from Johnson & Johnson, given the possibility that additional data will show the shots are viable beyond their expiration date at month’s end. Dr. Janet Woodcock, acting commissioner of the Food and Drug Administration, told state officials during a White House call Tuesday that they could store expired doses until new data shows whether the vaccines are safe to use, according to multiple state officials. (Pradhan and Jewett, 6/8)
ABC News:
Oklahoma May Throw Out Thousands Of COVID-19 Vaccines As Demand Drops
Oklahoma may be forced to throw out tens of thousands of vaccines set to expire in coming weeks, according to the state health department. "We have pulled expired vaccine from active inventory and are in the process of following CDC guidance on proper disposal," Keith Reed, deputy commissioner of the Oklahoma State Department of Health, told ABC News. In addition to a few thousand vaccines that have already gone to waste, there are approximately 80,000 Johnson & Johnson doses set to expire by the end of June, though that number may be adjusted downward after the state evaluates its inventory, according to Reed. (Schumaker, 6/8)
The Hill:
White House: 'Small Fraction' Of COVID-19 Vaccine Doses Will Be Unused
White House officials on Tuesday said they were not concerned about the potential for states to have unused Johnson & Johnson vaccine doses go to waste, adding that the federal government is working on strategies to extend the vaccine's shelf life. "Our first goal and our first opportunity is that every dose that’s been ordered by a governor in a state gets used," White House COVID-19 adviser Andy Slavitt told reporters. (Weixel, 6/8)
NBC News:
Many Johnson & Johnson Covid Vaccine Doses May Be Close To Expiring
State officials are aware that people in other countries are eager to get the Johnson & Johnson vaccine, said Dr. Marcus Plescia, medical director of the Association of State and Territorial Health Officials. Plescia described a growing fear among his members that Johnson & Johnson vaccine doses, which are coveted in the developing world, could go to waste if no national effort emerges. (Strickler, 6/8)
In related news, Africa and other nations clamor for shots —
AP:
'This IS INSANE': Africa Desperately Short Of COVID Vaccine
In the global race to vaccinate people against COVID-19, Africa is tragically at the back of the pack. In fact, it has barely gotten out of the starting blocks. In South Africa, which has the continent’s most robust economy and its biggest coronavirus caseload, just 0.8% of the population is fully vaccinated, according to a worldwide tracker kept by Johns Hopkins University. And hundreds of thousands of the country’s health workers, many of whom come face-to-face with the virus every day, are still waiting for their shots. (Imray, 6/9)
Axios:
Mastercard Foundation Donates $1.3 Billion To Africa's COVID-19 Response
The Mastercard Foundation announced a $1.3 billion donation aimed at improving Africa's coronavirus response Tuesday, the Washington Post reports. The funding will be distributed over three years and is intended to help acquire vaccines for more than 50 million people and improve manufacturing and delivery systems. (Reyes, 6/8)
The Washington Post:
Biden’s Global Vaccine Strategy Draws Scrutiny Ahead Of G-7 Pandemic Talks
President Biden is set to take the global stage this week with a coronavirus vaccine-sharing strategy that has been panned by congressional Democrats and some health advocates as too timid, drawn flak from European allies as too bold and led to frustration within his administration. It has also prompted a flurry of White House efforts to answer critics, with new announcements to bolster the plan expected ahead of the president’s appearance at the Group of Seven summit in Britain this weekend. (Diamond and Rauhala, 6/8)
Biden's July 4 Vaccine Goal May Be At Risk Thanks To Gen Z's Hesitancy
The White House's target of 70% of adults at least partially vaccinated by July 4 may be missed because roughly a quarter of Gen Z adults say they don't plan on getting vaccines. Meanwhile, Michigan is seeing a surge in covid hospitalizations for people aged under 18.
AP:
US Increasingly Unlikely To Meet Biden's July 4 Vax Goal
For months, President Joe Biden has laid out goal after goal for taming the coronavirus pandemic and then exceeded his own benchmarks. Now, though, the U.S. is unlikely to meet his target to have 70% of Americans at least partially vaccinated by July 4. The White House has launched a month-long blitz to combat vaccine hesitancy and a lack of urgency to get shots, particularly in the South and Midwest, but it is increasingly resigned to missing the president’s vaccination target. The administration insists that even if the goal isn’t reached, it will have little effect on the overall U.S. recovery, which is already ahead of where Biden said it would be months ago. (Miller and Willingham, 6/9)
Roll Call:
Gen. Z Needs To Get Vaccinated, And This College Student Has TikToks To Make It Happen
About 26 percent of Gen Z adults said they didn’t plan on getting the coronavirus vaccine, according to a Morning Consult poll in March. But Jordan Tralins, a sophomore at Cornell University, has been working to produce TikToks and Instagram slideshows to help combat vaccine hesitancy among her generation. Tralins and classmate Olivia Pawlowski founded the COVID Campus Coalition, which started at Cornell but has since expanded to students at over 20 universities. The group has accounts on social media platforms like TikTok and Instagram to share information about vaccines and fight disinformation that continues to crop up online. (McKinless and Cohen, 6/8)
Roll Call:
Young Adults Shun COVID-19 Vaccine As White House Warns Of Risks
Young adults in Generation Z are refusing the COVID-19 shot at a higher rate than other age groups, a development that many public health experts and White House officials worry could prolong the virus’s spread and lead to dangerous new mutations. “For young people who may think this doesn’t affect you, listen up, please. This virus, even a mild case, can be with you for months. It will impact on your social life,” President Joe Biden said at the White House on June 2. (Cohen, 6/8)
Modern Healthcare:
Teen COVID Hospitalization Spike Spurs Mass Vaccination Effort
Michigan's COVID-19 hospitalization rate surged by 311% among ages under 18-years-old from February through April, forcing providers to perform procedures rarely used on children with respiratory infections. Dr. Matthew Denenberg, an emergency pediatric physician, and his colleagues at the Children's Hospital of Michigan pumped the hearts of multiple kids infected with COVID-19 through an ECMO Machine over the past few months. His hospital is one of three in the state licensed to perform the procedure on children, rarely is it employed, as it is a last resort to provide circulation to the body. (Gellman, 6/8)
In other news about the vaccine rollout —
The New York Times:
Wisconsin Pharmacist Who Tampered With Vaccine Gets 3-Year Sentence
A hospital pharmacist who pleaded guilty to trying to spoil more than 500 doses of a Covid-19 vaccine was sentenced on Tuesday to three years in prison, federal prosecutors in Wisconsin announced. The pharmacist, Steven R. Brandenburg, 46, was also sentenced to three years of supervised release and ordered to pay nearly $84,000 in restitution to the Aurora Medical Center in Grafton, Wis., where he worked an overnight shift. (Paybarah, 6/8)
Modern Healthcare:
Houston Methodist Suspends 178 Workers For Not Getting Vaccinated
Houston Methodist suspended 178 workers for failing to get fully vaccinated by the deadline set by the health system, the CEO said Tuesday. In a letter to all employees and physicians, CEO Marc Boom said the 178 workers will be suspended without pay for two weeks, giving them another chance to either get the second dose of the Pfizer or Moderna vaccine or a single-shot Johnson & Johnson vaccine. In April, Boom told employees that COVID-19 vaccines would be mandatory, and those who did not comply would face termination. (Christ, 6/8)
Los Angeles Times:
COVID-19 Vaccine Site Opens At L.A.'s Union Station
A COVID-19 vaccination site opened Tuesday at downtown Los Angeles’ Union Station as the effort to get shots into more residents’ arms ramped up ahead of the state’s planned reopening next week. L.A. Mayor Eric Garcetti highlighted the convenience of the site at a news conference, noting that the transportation hub is widely used by commuters. Before the pandemic, roughly 110,000 people traveled through the station every day, he said. (Seidman, 6/8)
Axios:
Trump's Surgeon General Criticizes Alcohol-Related Vaccine Incentives
Jerome Adams, the U.S. surgeon general under former President Trump, criticized states who are offering lottery tickets, beer and donuts as prizes for getting the coronavirus vaccine. Adams said he was "uncomfortable" with the "public health trade offs" involved with certain kinds of vaccine incentives, pointing to a report put out by the current surgeon general warning about the health effects of alcohol consumption. (Rummier, 6/8)
KHN:
An Anti-Vaccine Film Targeted To Black Americans Spreads False Information
When a filmmaker asked medical historian Naomi Rogers to appear in a documentary, the Yale professor didn’t blink. She had done these “talking head” interviews many times before. She assumed her comments would end up in a straightforward documentary that addressed some of the most pressing concerns of the pandemic, such as the legacy of racism in medicine and how that plays into current mistrust in some communities of color. The subject of vaccines was also mentioned, but the focus wasn’t clear to Rogers. (Stone, 6/9)
Pfizer Trial Using Lower-Dose Vaccine In 5- To 11-Year-Olds
Adults get 30 micrograms of covid vaccine per shot, but Pfizer's research and testing is moving toward 10 microgram doses for younger kids. Meanwhile research shows a single dose of the adult Pfizer vaccine is 51% protective against covid infections in real-world situations.
ABC News:
Pfizer Advances Clinical Trials For 5- To 11-Year-Olds At Lower Doses
Pfizer is advancing Phase 2/3 clinical trials for young kids at lower doses than vaccines for adults, the pharmaceutical company announced Tuesday. Based on safety, efficacy and tolerability data from Pfizer's Phase 1 trial, the company will use 10 micrograms of each vaccine dose for kids between the ages of 5 and 11 in Phase 2/3 trials, and 3 micrograms of each dose for those 5 and younger. People ages 12 and older received 30 micrograms in each dose. (Schumaker, 6/8)
USA Today:
Pfizer COVID Vaccine: Next Phase Of Trials In Young Children To Begin
Pfizer released details Tuesday about the progress of its COVID-19 vaccination trials in children, showing that they have completed early testing and are moving forward with lower-dose trials in younger kids. Children are less likely than adults to have a serious case of COVID-19, so drug companies are trying to minimize vaccine side effects while maximizing benefits. (Weintraub, 6/8)
Fox News:
Pfizer Lowers COVID-19 Vaccine Doses For Younger Kids In Clinical Trial
Pfizer said it has selected lower dosages of its COVID-19 vaccine for Phase 2/3 portions of its clinical trial involving kids younger than 11 than the volume given to shot recipients ages 12 and older. For children ages 5-11 the vaccine will be given at a 10 microgram (ug) dose level, while those younger than 5 down to 6 months will receive a 3 ug dose level. The shots will continue to be given in a two-dose regimen. Currently, the FDA has granted emergency use authorization to Pfizer for its COVID-19 two-dose vaccine in people ages 12 and older. Everyone 12 and over receives two doses of 30 ug each given three weeks apart. (Hein, 6/8)
In other vaccine-development news —
CIDRAP:
Single Dose Of Pfizer COVID Vaccine 51% Protective, Real-World Data Show
A single, 30-microgram dose of the Pfizer/BioNTech COVID-19 vaccine was 51% effective for any SARS-CoV-2 infection and 54% for symptomatic infections, according to a study yesterday in JAMA Network Open. The research cohort consisted of 503,875 Israelis 16 years and older who received a single dose from Dec 19, 2020, to Jan 15, 2021. A little more than half (52.4%) were women, the mean age was 59.7 years, and 69.8% had follow-up data for days 13 to 24 post-vaccination in addition to days 1 to 12. (6/8)
Fox News:
Maine Says 8 Vaccinated Residents Died 'With COVID-19'
The Maine Centers for Disease Control and Prevention (CDC) has reported that eight residents who were fully vaccinated against coronavirus have died with COVID-19, including some who were inoculated while receiving end-of-life care. A coronavirus infection acquired 14 days post-final vaccination dose is considered a "breakthrough case." As of June 4, the state had reported 387 such cases. Breakthrough cases are expected, the CDC has previously said, and there may be a small percentage of fully vaccinated people who still get sick, are hospitalized or die from the virus. (Hein, 6/8)
The Boston Globe:
Why Does The Johnson & Johnson Vaccine Work Against Variants? A New Study Suggests An Answer
New research suggests that Johnson & Johnson’s single-dose COVID-19 vaccine provides protection against worrisome virus variants — but perhaps not for the reasons researchers originally thought. The findings, published Wednesday in the peer-reviewed journal Nature, come from a 25-person study at Beth Israel Deaconess Medical Center in Boston, which looked at immune responses to variants first discovered in Brazil, South Africa, Southern California, and the United Kingdom. Twenty people in the study received the Johnson & Johnson vaccine, five received a placebo, and their blood samples were analyzed 57 and 71 days days after their shot. (Gardizy, 6/9)
Fauci Raises Alarm Over Spread Of Delta Covid Variant
Though the U.K. has high vaccination levels, the Delta variant is "essentially taking over" there, Dr. Anthony Fauci said, warning that the same could happen in the U.S. if slow vaccination continues. Reports say the variant already accounts for 6% of new U.S. cases.
Bloomberg:
Fauci Warns U.S. Of Threat From New Covid Variant
U.S. health officials warned that a more harmful Covid-19 variant known as Delta has surged in the U.K. (a country with high vaccination levels) in a grim warning to America as demand for inoculations in some states fades (only 42% of the U.S. is fully vaccinated). White House adviser Anthony Fauci said on Tuesday that the variant first reported in India dominates new infections in Britain. “It’s essentially taking over,” he said. “We cannot let that happen in the U.S.” Delta has been reported in 60 countries including America, which is still the world’s worst hit by number of coronavirus infections and deaths, the latter totaling almost 600,000. That’s about one-sixth of all confirmed virus fatalities worldwide. Here’s the latest on the pandemic. (Rovella, 6/8)
CNBC:
Fauci: U.S. Must Vaccinate More People Before Delta Becomes Dominant Covid Variant
U.S. health officials are scrambling to get more Americans vaccinated to keep the Delta variant, first identified in India, from proliferating across the United States. The variant has become the dominant strain in the U.K., accounting for an estimated 60% of new cases. It’s now more prevalent than the Alpha strain, formerly called the B.1.1.7 strain, which was first identified in the U.K., and transmission is peaking in people between the ages of 12 and 20, White House chief medical advisor Dr. Anthony Fauci said at a press briefing Tuesday. (Mendez, 6/8)
The Washington Post:
Delta Variant Accounts For 6 Percent Of New U.S. Coronavirus Infections
A highly transmissible coronavirus variant first identified in India accounts for 6 percent of new infections in the United States, the Biden administration said Tuesday. Yet vaccines appear to be highly effective against this version of the virus that has quickly spread into Great Britain and elsewhere. Anthony S. Fauci, the nation’s leading infectious-disease expert, revealed the extent of the variant’s push into the United States, but said it appears to be slowed by vaccines. (Bernstein, 6/8)
In other updates on the spread of the coronavirus —
CNN:
America Reports Lowest Average Of Daily Covid-19 Infections And Deaths Since March 2020. But Experts Warn Millions Are Still Vulnerable
The US is making significant strides in curbing the coronavirus pandemic just in time for the summer, with reported infections reaching a new low over the last year. The country averaged less than 14,400 daily reported infections and 427 deaths over the past seven days, according to Johns Hopkins University data. It's the lowest the US has seen since late March 2020, just weeks after the pandemic was first declared. The good news comes as about 42% of Americans are fully vaccinated, while nearly 52% have received at least one dose of the vaccine, according to the US Centers for Disease Control and Prevention. (Elamroussi, 6/9)
PBS NewsHour:
This Chart Shows How COVID Cases Have Plummeted As More People Get Vaccinated
Less than six months ago, the coronavirus crisis was at its most deadly point. Now, with more than half the country at least partially vaccinated, Americans are seeing what life looks like at the other side of the curve. New daily COVID-19 infections have declined dramatically in the United States, recently hitting their lowest numbers since March of 2020. (Isaac-Thomas, 6/8)
Also —
New York Post:
These Treatments Can Help COVID-19-Related Hair Loss, Doctors Say
There’s a big fallout from the pandemic.Hair loss brought on by the COVID-induced stress and anxiety of the past 18 months is plaguing women, but they’re finding help with a range of innovative — though often costly — treatments. "About 30 percent of my patients were e-mailing about hair loss," said Michele Green, a dermatologist at Lenox Hill. "It was frightening. Some had sheets of hair falling out." (Lewak and Fleming, 6/8)
CNBC:
Aspirin Does Not Improve Survival For Covid Patients: UK Study
The cheap and widely-available drug aspirin does not improve survival for patients hospitalized with Covid-19, a U.K. study has found. Oxford University researchers had hoped to find that the blood-thinning medicine could help hospitalized Covid-19 patients who are at an increased risk of clots forming in their blood vessels, particularly in the lungs, but found aspirin didn’t help to prevent deaths. (Ellyatt, 6/9)
CIDRAP:
Ghosts In The Machine: Malicious Bots Spread COVID Untruths
Malicious bots, or automated software that simulates human activity on social media platforms, are the primary drivers of COVID-19 misinformation, spreading myths and seeding public health distrust exponentially faster than human users could, suggests a study published yesterday in JAMA Internal Medicine. Led by University of California at San Diego (UCSD) researchers, a team analyzed a sample of roughly 300,000 posts on heavily bot-influenced public Facebook groups to measure how quickly the posts' links were shared. (Van Beusekom, 6/8)
When Did Covid Really Hit The US? GOP Lawmakers Ask CDC To Study
Suspecting that infections began earlier than currently estimated, Republicans on a key House committee are urging the Centers for Disease Control and Prevention to use medical records and blood work to determine the virus' lifecycle. Also on covid's origins: the European Union backs the call from the U.S. for a new study.
CBS News:
Republicans On House Panel Ask CDC To Determine If COVID-19 Was In U.S. Earlier Than Reported
Republicans on the House Committee on Energy and Commerce are asking the Centers for Disease Control and Prevention to investigate early possible COVID-19 cases and blood work in the U.S. to determine whether the virus was present in the country earlier than current estimates. Specifically, committee Republicans sent a letter to CDC Director Rochelle Walensky asking the CDC to use the most accurate tests available to test more blood samples from 2019 and investigate early unexplained deaths to determine if the virus was in the country earlier than December 13, 2019. The request is part of committee Republicans' investigation into the origins of COVID-19. (Watson and Gazis, 6/8)
Bloomberg:
U.S. Gets Crucial EU Support For New Study Into Covid’s Origins
The U.S. and the European Union are set to back a renewed push into investigating the origins of Covid-19 after conflicting assessments about where the outbreak started, according to a document seen by Bloomberg News. In a draft statement the countries hope to adopt at a summit later this month, they “call for progress on a transparent, evidence-based, and expert-led WHO-convened phase 2 study on the origins of COVID-19, that is free from interference.” (Nardelli and Wingrove, 6/8)
AP:
EXPLAINER: The US Investigation Into COVID-19 Origins
Once dismissed by most public health experts and government officials, the hypothesis that COVID-19 leaked accidentally from a Chinese lab is now receiving scrutiny under a new U.S. investigation. Experts say the 90-day review ordered on May 26 by President Joe Biden will push American intelligence agencies to collect more information and review what they already have. Former State Department officials under President Donald Trump have publicly pushed for further investigation into virus origins, as have scientists and the World Health Organization. (Larson and Merchant, 6/9)
Also —
The Wall Street Journal:
Over 47,000 Wild Animals Sold In Wuhan Markets Before Covid Outbreak, Study Shows
More than 47,000 wild animals were sold in the Chinese city of Wuhan in the two and a half years before the first confirmed Covid-19 cluster was found there, a new study showed, providing critical new evidence that the coronavirus could have spread naturally from animals to humans. The study, published in the open-access journal Scientific Reports, revealed that the wild animals, including 31 protected species, were often butchered on site in markets, and stored in the kinds of cramped, unhygienic conditions that can allow viruses to hop species. (Page, Hinshaw and McKay, 6/8)
US Lowers Travel Risk Warnings To Dozens Of Nations
The Centers for Disease Control and Prevention and the State Department revised its covid travel guidance to 120 countries. In dozens of cases, the warnings were eased for vaccinated Americans.
CNN:
CDC Issues New Advice For More Than 120 Countries
As more people get vaccinated and the spread of Covid-19 becomes more controlled, public health officials are issuing new travel advice for more than 120 countries. The US Centers for Disease Control and Prevention updated its international travel guidance on Monday to give specific advice for both vaccinated and unvaccinated travelers. The update includes moving 33 countries, including Iceland, Israel and Singapore, into the lowest risk category. (Prior, 6/9)
Bloomberg:
US State Dept Eases Travel Warning For Canada, Mexico, France, Germany
The U.S. State Department loosened its travel warnings for dozens of nations including France, Canada and Germany, in a move that could ease airline restrictions for people wanting to go overseas as the coronavirus pandemic wanes in parts of the world. The department changed its travel warnings Tuesday for nearly 60 nations and territories from level 4, or “do not travel,” to level 3, “reconsider travel,” according to the agency’s website. In a statement, the department said it was updating the advisories after the U.S. Centers for Disease Control and Prevention changed the methodology for its travel health notices. (Wadhams, 6/8)
NPR:
U.S. Lowers The Travel Risk Rating For Japan, Where COVID Still Shadows The Olympics
The U.S. Centers for Disease Control and Prevention and the State Department have issued new travel advisories lowering the threat of COVID-19 in more than 90 countries and territories, including Japan, which is in the grips of a new wave of infections ahead of the Olympics next month. The CDC lowered Japan from its highest risk category — Level 4 — to a Level 3, on Monday, Reuters first reported. It also moved 61 other countries to the same tier and another 50 were dropped to Level 2 or Level 1. Additionally, the CDC has revised its rating for the United States from Level 4 to Level 3. (Romo, 6/8)
Biden Shuts Down Infrastructure Negotiations With Republicans
Hopes of a compromise dimmed as entrenched divisions prompted President Joe Biden to call off compromise talks over the infrastructure bill with a group of six Republicans, led by Sen. Shelley Moore Capito of West Virginia. The White House will turn attention to another bipartisan proposal or look to pass measures through reconciliation.
The New York Times:
Biden Ends Infrastructure Talks With Republicans, Falling Short Of A Deal
President Biden on Tuesday ended a weekslong effort to reach a deal with Senate Republicans on an expansive infrastructure plan, cutting off negotiations that had failed to persuade them to embrace his bid to pour $1 trillion into the nation’s aging public works system and safety-net programs. It was a major setback to Mr. Biden’s effort to attract Republican support for his top domestic priority, which had always faced long odds over the size, scope and financing of the package. Most Republicans have made it clear they are willing to spend only a fraction of what Democrats want on a much narrower initiative, and balked at any tax increases to pay for it. (Cochrane, 6/8)
The Wall Street Journal:
President Biden Ends Infrastructure Talks With Senate GOP Group
President Biden called off an effort to reach an infrastructure compromise with several Senate Republicans after progress stalled, shifting his focus to a separate set of negotiations with a group of Republicans and Democrats in an effort to salvage a bipartisan deal on the issue. At the same time, Senate Democrats signaled they were preparing to move at least part of an infrastructure package forward through a process relying on only Democratic support. (Duehren, Siddiqui and Peterson, 6/9)
Fox News:
Bipartisan Caucus Endorses Its Own Proposal After Infrastructure Talks Fizzle
Shortly after talks on President Biden's infrastructure plan fell through on Tuesday when talks between the White House and Republican senators fizzled, there was significant movement on an additional bipartisan effort to come up with a deal. The House Problem Solvers Caucus voted and endorsed its own proposal: an 8-year package that comes with a $1.249 trillion price tag, including about $500 billion in new spending. (The actual new spending is $761.8 billion over the timeframe, but an aide for Rep. Josh Gottheimer, the Democrat co-chair of the caucus, made an error. It is yet to be seen if the revised number becomes an issue going forward. The error does not affect the total price tag.) (Heinrich and DeMarche, 6/9)
Roll Call:
After Infrastructure Talks Collapse, Two Options For Biden
The collapse of negotiations between the White House and a group of Senate Republicans on an infrastructure spending package leaves President Joe Biden with two options to advance his ambitious public works vision: bipartisan agreements where possible and budget reconciliation rules where not. (Wehrman and Lesniewski, 6/8)
White House Wants To Shore Up Made-In-America Prescription Drug Pipeline
News reports on other Biden administration health initiatives focus on preparing for the next pandemic, asbestos disclosures and a high-profile staff departure.
Modern Healthcare:
Biden Administration Pushes Domestic Pharmaceutical Production
The Biden administration aims to boost U.S.-based production of pharmaceuticals and their ingredients, among other initiatives looking to shore up the supply chain, according to a new report. HHS, the Defense Department and other agencies should increase their funding related to producing active pharmaceutical ingredients in critical drugs, the White House recommended in its review of supply chain disruptions caused or exacerbated by the COVID-19 pandemic. HHS should also track production by facility and where API is sourced to improve transparency. (Kacik, 6/8)
Roll Call:
Biden Would Slash Pentagon Money For Pandemic Prevention
President Joe Biden has proposed cutting by nearly half the Pentagon’s budget for the leading U.S. government program for preventing, detecting and responding to global disease outbreaks, a move that even the White House’s staunchest allies on Capitol Hill oppose as the nation continues to grapple with the COVID-19 pandemic. The so-called Biological Threat Reduction Program finds and fights emerging global diseases that can threaten U.S. troops and, ultimately, the world’s population. In fact, the Pentagon program funded a lab in Thailand that detected in January 2020 the first case of novel coronavirus outside China. (Donnelly, 6/8)
San Francisco Chronicle:
EPA Agrees To Disclose Data On Products Containing Asbestos, Reversing Trump Protocol
The Biden administration, in response to a suit by California, other states and environmental advocates, has agreed to collect and disclose information from companies whose products contain the cancer-causing mineral asbestos. Asbestos is found in items ranging from brake linings to clothing fabrics. Since 2016, federal law has required the Environmental Protection Agency to obtain information from large-scale importers and producers of products containing potentially hazardous chemicals, including asbestos. The agency then is supposed to evaluate the risks and adopt rules that, based on its findings, could prohibit U.S. manufacture and distribution of the chemical and products that contain it. (Egelko, 6/8)
Also —
Axios:
White House COVID-19 Senior Adviser Announces Departure
Andy Slavitt, the White House senior adviser for coronavirus response, announced on Tuesday he is leaving his temporary role. Slavitt, who was appointed to the position in January and was expected to leave this month, urged Americans in his final press briefing to not "let our progress be a reason for taking our foot off the pedal." (Doherty, 6/8)
Pharma Injected Big Money Into Thousands Of 2020 Congressional, State Campaigns
An analysis by Stat News of campaign finance records shows that the pharmaceutical industry donated to more than two-thirds of Congress as well as 2,467 state lawmakers during the last campaign cycle -- to the tune of over $25 million. Stat also examines what type of political influence that may have bought.
Stat:
Two-Thirds Of Congress Cashed A Pharma Campaign Check In 2020
Seventy-two senators and 302 members of the House of Representatives cashed a check from the pharmaceutical industry ahead of the 2020 election — representing more than two-thirds of Congress, according to a new STAT analysis of records for the full election cycle. Pfizer’s political action committee alone contributed to 228 lawmakers. Amgen’s PAC donated to 218, meaning that each company helped to fund the campaigns of nearly half the lawmakers on Capitol Hill. Overall, the sector donated $14 million. (Facher, 6/9)
Stat:
Pharma Funded Over 2,400 State Lawmaker Campaigns In 2020
State lawmakers in Oregon have tried to lower high drug prices from nearly every angle: They’ve sought to cap how much people can pay for insulin, install a panel that could determine how much state agencies should pay for medicines, and even import drugs in bulk from Canada. Nearly every proposal has failed. One reason, at least according to the effort’s supporters: Two-thirds of the state legislature accepted at least one campaign check from the drug industry during the 2020 election cycle. The trade group PhRMA, alone, wrote checks to 43 of the legislature’s 90 lawmakers. (Facher, 6/9)
Study Examines How Race Factors Into Medicare Advantage Enrollment
A Health Affairs study out Tuesday found that Medicare Advantage enrollment among Black people outpaced the enrollment of whites from 2009-18.
Modern Healthcare:
Black, Dual-Eligible Enrollment In Medicare Advantage Rises
Medicare Advantage enrollment among Black people, dual-eligibles, and those residing in the most disadvantaged areas outpaced growth of white and non-dual eligibles from 2009 through 2018, according to a Health Affairs study published Tuesday. While their enrollment in MA plans climbed, beneficiaries in these groups also tended to have lower quality options from which to choose. Assuming the enrollment trend continues, the study predicted that the majority of Black, Hispanic, and dual enrollees will be in a Medicare Advantage plan, as opposed to Medicare fee-for-service, over the next five years. The majority of all Medicare beneficiaries are expected to be in Medicare Advantage within the next 10 years, according to 2020 estimates by the Congressional Budget Office. While this trend corresponds with broader changes in demographics and geographic distribution, the study suggests policymakers look into solutions to the disproportionate coverage. (Gellman, 6/8)
Philadelphia Inquirer:
Racial Equity Is Essential To Hospital Quality And Some In Philly Are Falling Short, New Report Says
The coronavirus pandemic and unrest following the death of George Floyd were painful reminders of deep racial inequality in the U.S. health care system and renewed calls for change. Hospitals, the epicenter of pandemic response in many communities, have responded with a range of initiatives, many of which began years ago: Bias training for doctors and executives, accelerated hiring plans to diversify care teams, outreach programs to forge stronger connections with underserved communities. But whether any of it will mean better care for people of color, improve patient trust or reduce racism in the health system is an open question. (Gantz, 6/8)
Modern Healthcare:
UnitedHealth Group Names New Chief Diversity, Equity And Inclusion Officer
UnitedHealth Group announced on Tuesday that Joy Fitzgerald will serve as the healthcare giant's new Chief Diversity, Equity and Inclusion Officer. Fitzgerald joins the Minnetonka, Minn.-based company from Eli Lilly, where she most recently served as Chief Diversity & Inclusion Officer. Fitzgerald also served as chief diversity officer for Cedar Rapids, Iowa-based, aerospace company, Rockwell Collins, where she held other leadership roles focused on learning and organizational development. (Tepper, 6/8)
In other health care industry news —
Las Vegas Review-Journal:
Feds Fine Centennial Hills Hospital For Dodging Overtime Rules
Centennial Hills Hospital Medical Center has been fined $19,090 for failing to pay employees all the hours they worked and “willfully” manipulating time cards to avoid paying overtime, the U.S. Department of Labor announced Tuesday. The hospital in the northwest Las Vegas Valley paid $145,402 in back wages to 23 employees following an investigation from the labor department’s wage and hour division. The investigation concluded that the hospital violated the Fair Labor Standards Act by requiring employees to fill out necessary paperwork after clocking out. (Miranda, 6/8)
North Carolina Health News:
Proposed Bills Would Bump Up Pay For People Caring For NC’s Most Vulnerable
In 2004, two weeks after her high school graduation, Brittany Stone was driving to pick up her younger sister from vacation Bible school during a storm. She hit a pothole and lost control of her vehicle. In the accident, she suffered a traumatic brain injury. Seventeen years later, Stone has landed a place at Whittecar Group Home in Raleigh, where she and five other residents get the help they need to live their lives. For the most part residents at the group home can take care of their basic needs, but Stone, for example, has trouble washing her back and hair because of tremors. She uses a walker to get around, but she does chores around the house. She can’t drive or run to the store independently. The people who help the six residents live their lives start at a salary of $11.50 an hour. (Dougani, 6/9)
AP:
Library Of Congress Gets Health Workers' Audio COVID Diaries
The Library of Congress has acquired a digital archive of the real-time impressions of more than 200 frontline health care workers documenting the country’s descent into the coronavirus pandemic. Calvin Lambert, a fetal medicine fellow in a Bronx hospital, recalls how a Black pregnant woman who came in for a checkup “became irate and became scared” even when he attempted to give her a COVID-19 test. She thought the nasal swab itself would give her the virus. (6/8)
Health News Florida:
Twitter Suspends Account Of Former Florida Data Analyst Rebekah Jones
Twitter has suspended the account of former Department of Health COVID-19 data analyst Rebekah Jones. In email correspondence with WFSU, Jones says she posted a Miami Herald article, "a few dozen times too many and got auto-flagged for spam." According to a screen capture provided by Jones, Twitter stated the company had suspended her account due to violating rules against platform manipulation and spam. (Gaffney, 6/8)
Lawsuit Claims Nursing Home Fired Nurse For Covid Whistle-Blowing
Donna Frank claims she was fired after reporting concerns about infection control and a lack of PPE. Separately, in Buffalo a lawsuit is filed over the covid deaths of a husband and wife in a nursing home, while Ohio's Senate nixes some plans for nursing home oversight.
The Courier-Journal:
Nurse Says She Was Fired By Nursing Home Over COVID-19 Complaints
A former nurse at a Louisville nursing home claims in a lawsuit she was fired last year after raising repeated concerns about infection control and lack of personal protective equipment, such as masks, during the COVID-19 pandemic. Donna Frank, a registered nurse, alleges in the lawsuit filed June 3 she was wrongly fired by Signature Healthcare at Jefferson Place Rehab and Wellness Center after about six months on the job. Frank was fired Sept. 9, 2020, the day after an investigator from the state Cabinet for Health and Family Services Office of Inspector General showed up to investigate conditions at Signature-Jefferson Place, following a complaint from Frank. (Yetter, 6/9)
Buffalo News:
Lawsuit Over Couple’s Covid-19 Deaths Challenges Nursing Homes' Immunity
The Covid-19 deaths of a husband and wife who died two days apart in an Albion nursing home has set the stage for what's believed to be among the first lawsuits challenging the controversial pandemic immunity the state granted to medical facilities. The lawsuit alleges William F. Ames, 89, and Martha F. Ames, 88, contracted the virus at the Villages of Orleans Health and Rehabilitation Center because the nursing home lacked adequate preventative infectious control policies, sufficient staffing and enough personal protective equipment. (Michel, 6/9)
New York Post:
Feds Subpoena Top Cuomo Aides Over Nursing Home Policy, COVID Book
Federal investigators have sent out subpoenas to Gov. Andrew Cuomo’s top aides, seeking information pertaining to his nursing home policies in his $5.1 million pandemic memoir, the Wall Street Journal reported late Monday. The report said the Brooklyn US Attorney’s office has asked for documents including contracts and other materials used to pitch the book, “American Crisis” to publishers. According to the Journal, the subpoenas were sent last month to people involved in early edits of the poor-selling tome — including state officials. (Hogan and Chamberlain, 6/7)
Cincinnati Enquirer:
Ohio Senate Republicans Aim To Nix Some State Nursing Home Oversight
The sway of Ohio's nursing home industry over the state legislature is holding steady, despite a pandemic where many such centers became COVID-19 hotspots. Senate Republicans last week in the state budget bill greatly reduced, if not outright eliminated, key provisions put forth by Gov. Mike DeWine that would put more checks on skilled nursing facilities. The industry praised the changes as a fight back against unnecessary government overreach, but opponents fear they could put nursing home residents at more risk. In contrast, the House had made relatively minor modifications, if not left the two provisions untouched. The Senate's harder stance sets the stage for needed negotiations in order for a compromise to be reached by the end of June. (Wu, 6/8)
Also —
Axios:
America's Nursing Homes Fight To Find Enough Caregivers
Skilled nursing and assisted living facilities across the country are having trouble hiring enough caregivers, and many have turned to perks like referral bonuses and transportation to lure more talent. The industry historically grappled with high employee turnover for its lower-skilled jobs. But now nursing facilities are facing reputational hits from the pandemic and a red hot market for minimum wage workers. (Fernandez, 6/9)
KHN:
Zooming Into The Statehouse: Nursing Home Residents Use New Digital Skills To Push For Changes
Patty Bausch isn’t a Medicaid expert, lawyer or medical professional. But she still thinks Connecticut legislators need her input when they consider bills affecting people like her — the roughly 18,000 residents who live in the state’s nursing homes. With help and encouragement from Connecticut’s Long Term Care Ombudsman Program, Bausch signed up and testified remotely before a legislative hearing this year. Nursing home residents who have been using digital technology to reach out to family and friends — after the covid pandemic led officials to end visitation last year — could also use it to connect with elected officials once the legislature moved to remote hearings. Speaking into an iPad provided by the ombudsman’s office, Bausch testified without ever leaving her room at the Newtown Rehabilitation & Health Care Center, where she has lived since having a stroke three years ago. (Jaffe, 6/9)
Diabetes Plus Sleeping Badly Linked To Premature Deaths In Study
People with diabetes and sleep problems are 87% more likely to die during the next nine years than people without either issue, according to new research. Also in the news: an E. coli outbreak; gut bacteria and heart health; NFL funding of cannabis research; and more.
CNN:
People With Diabetes Who Sleep Badly Are At Greater Risk Of Dying Prematurely, Study Suggests
People with diabetes who had trouble falling or staying asleep were 87% more likely to die of any cause over the next nine years than people without diabetes or sleep problems, a new study finds. The study, published Tuesday in the Journal of Sleep Research, analyzed data from nearly half a million middle-aged participants in the UK Biobank Study, which houses in-depth genetic and health information on UK residents. (LaMotte, 6/8)
AP:
E. Coli Outbreak Among Children Prompts Health Officials Investigation
Health officials in eastern Iowa are looking for the source of an E. coli outbreak that has sickened several children in Maquoketa. At least three children from Maquoketa are being treated at an Iowa City hospital after developing hemolytic uremic syndrome, a serious complication caused by a toxin-producing E. coli strain, the Telegraph Herald reported. Doctors say the E. coli strain can cause diarrhea, stomach cramps and vomiting. HUS symptoms include dark-colored urine, increased fever, abdominal pain and headache and can affect kidney function. (6/8)
WJCT 89.9 FM:
UNF Study Looks At How Gut Bacteria May Affect Heart Health
A new study at the University of North Florida in Jacksonville is trying to make a connection between a happy gut and a healthy heart. Gut bacteria is connected to many types of disorders. UNF nutrition and dietetics professor Andrea Arikawa is conducting research on the effect that eating fermented vegetables, like Korean kimchi and sauerkraut, has on the body’s microbiome and heart health. (Corum, 6/8)
Bloomberg:
NFL Pledges $1 Million To Fund Cannabis Research For Pain Relief
The NFL says it plans to fund research into alternative pain medications to opioids, including potential studies on whether cannabis can effectively treat pain without having a negative effect on elite athletes. The league is offering $1 million in grants for as many as five research proposals, Jeff Miller, executive vice president overseeing player health and safety, said on a media call Tuesday. (Kary, 6/8)
GenomeWeb:
Genomic Differences In Prostate Cancer Found Among African-Americans, European-Americans
Prostate cancer is common among men, with nearly 175,000 new cases each year in the U.S. But African-American men are more likely than European-American men to develop prostate cancer, and when they do, they have a higher mortality rate. Previous studies have suggested there might be genomic differences in the tumors found among African-American and European-American men, so an Icahn School of Medicine at Mount Sinai-led team conducted a retrospective analysis of tumors from more than a thousand men to examine differences in gene expression or affected biological pathways between the groups. As they reported in the journal Communications Biology this week, the researchers uncovered distinct genomic differences that could influence how prostate cancer should be managed clinically and that could, in part, explain disease disparities. (6/8)
In other public health news —
CNN:
The Coming Flu Season May Be A Doozy. Here's Why
The coming flu season may be a doozy. Even as coronavirus was devastating populations around the world, killing 3.7 million people globally, doctors and public health officials noticed something else was missing: There was almost no flu. One child died from flu this year in the US. In 2019-2020, there were 199 flu-related deaths in children and 144 the season before that. Flu cases, usually counted in the tens of millions, only accounted for a few thousand this year in the US. "Flu hasn't been anywhere, with the exception of some reasonable activity in western Africa," said Richard Webby, an influenza specialist at St. Jude Children's Research Hospital in Memphis. (Fox, 6/8)
CNN:
These Innovative Designs Are Tackling Taboo Health Issues For Women
A non-hormonal birth control capsule that women can insert just before sex. A rape kit that gives victims more agency and streamlines the evidence collection process. An overhauled design for a 150-year-old tool used in postpartum vaginal tearing. These designs are just some of the finalists announced this week in the 2021 Index Award, and their creators hope to make the future of medicine and sexual health more equitable for all genders. (Palumbo, 6/8)
CNN:
Dr. Gupta: How To Assess Risk When Going Mask-Free
For more than a year now, many of us have followed the standard drill: wash our hands, stay 6 feet apart, choose outdoor activities over indoors, and -- most of all -- wear a mask. Once vaccines were authorized for emergency use, the rules -- as laid out in guidelines from the US Centers for Disease Control and Prevention -- slowly started to change as more people got their shots. (Gupta, 6/8)
KHN:
Women Now Drink As Much As Men — And Are Prone To Sickness Sooner
Victoria Cooper thought her drinking habits in college were just like everyone else’s. Shots at parties. Beers while bowling. Sure, she got more refills than some and missed classes while nursing hangovers, but she couldn’t have a problem, she thought. “Because of what my picture of alcoholism was — old men who brown-bagged it in a parking lot — I thought I was fine,” said Cooper, now sober and living in Chapel Hill, North Carolina. (Pattani, 6/9)
New Migraine Drug Will 'Change The Paradigm' Of Treatment, Says CEO
Nurtec ODT, recently approved by the Food and Drug Administration, is reported on by CNBC. In other news, a Louisiana law bans insurer "white bagging" (bypassing hospital pharmacies), and the FDA also approves a new smallpox treatment, Tembexa.
CNBC:
Biohaven CEO Says Drug Approval Is 'Monumental' For Migraine Patients
Biohaven CEO Vlad Coric told CNBC Tuesday a recent approval of the company’s migraine drug will “change the paradigm” of migraine prevention and treatment. The U.S. Food and Drug Administration last week approved the medicine, Nurtec ODT, for preventative treatment of migraines. That comes about a year after Nurtec was first launched to treat the symptoms of debilitating headaches, making it the first pill approved for both acute treatment and prevention, according to Coric. (Clifford, 6/8)
Modern Healthcare:
New Louisiana Law Bans Insurer Practice Known As White Bagging
Louisiana hospitals are cheering a new state law that bans health insurers' controversial practice of white bagging, or bypassing hospital pharmacies for certain drugs. Across the country, health insurers are increasingly setting policies that funnel services away from hospitals in favor of less expensive settings. In this case, they're shipping doses of expensive physician-administered drugs, commonly cancer infusions, directly to hospitals instead of allowing hospitals to buy them using discounts and retrieve them from their in-house pharmacies. Insurers have defended the practice by arguing that getting drugs from their own network of specialty pharmacies helps keep healthcare more affordable. (Bannow, 6/8)
Stat:
Regeneron Shareholders Urged To Boot Board Member Over Exec Pay Practices
Two prominent shareholder advisory firms are urging Regeneron Pharmaceuticals (REGN) shareholders to remove a director who is on the compensation committee, citing concerns over “problematic” pay practices and “excessive” awards given to the top two executives. In separate investor alerts, the advisory firms argue the Regeneron board has showered chief executive officer Leonard Schleifer and president and chief scientific officer George Yancopoulos with upfront performance stock units worth $130 million over five years, rather than annual grants. This approach may lock in executives, but the firms say it also robs the board of flexibility if job performance changes during that time. (Silverman, 6/8)
CIDRAP:
FDA Approves 2nd Smallpox Treatment, Tembexa
The US Food and Drug Administration (FDA) has approved Tembexa (brincidofovir) to treat smallpox. This is the second approved smallpox drug; the first, TPOXX (tecovirimat), was approved in 2018.The World Health Organization declared smallpox eradicated in 1980, but since then many nations have expressed concerns that the variola virus, which causes smallpox, could be used as a bioweapon. (6/8)
In updates on the opioid crisis —
The Herald-Dispatch:
Retired DEA Official Says Distributors' Pill Monitoring Systems Were A Systemic Failure
While a retired high-ranking official with the Drug Enforcement Administration said drug distributors’ neglect in reporting suspicious opioid pill orders was part of a systemic failure, the defendants said the real issue was with the regulator’s practices. The official — Joe Rannazzisi, head of the Office of Diversion Control for the DEA from 2006 to 2015 — testified Tuesday in Charleston at the ongoing opioid trial. Cabell County and Huntington are accusing the “Big Three” drug wholesalers — AmerisourceBergen, Cardinal Health and McKesson — of fueling the opioid crisis by sending excessive shipments of opioids into the area for eight years before a reduction in the number of pills shipped made users turn to illicit drugs. (Hessler, 6/8)
San Francisco Chronicle:
SFPD's Fentanyl Bust: 'Enough Lethal Overdoses To Wipe Out San Francisco's Population Four Times Over"
San Francisco police arrested five men and seized 16 pounds of fentanyl — enough to kill the city’s population four times over — in a narcotics operation in Oakland meant to block deadly drugs from entering the city’s Tenderloin neighborhood, authorities said Tuesday. The arrests and seizures last Thursday involved two semi-automatic guns that were not registered, more than $45,000 in cash and nearly 30 pounds of drugs, including the fentanyl. (Hernández, 6/8)
Biogen Alzheimer's Drug Approval Prompts FDA Expert To Resign
An agency advisory committee recommended against the Food and Drug Administration approving Aduhelm, and one of its expert members has since resigned. More controversy about the drug's approval is reported in CNBC, Stat, Axios, The Baltimore Sun and Fox News.
Stat:
Member Of FDA’s Expert Panel Resigns Over Alzheimer’s Therapy Approval
Following the Food and Drug Administration’s polarizing authorization of the Alzheimer’s therapy Aduhelm on Monday, a member of an agency advisory committee that recommended against the drug’s approval has resigned. Neurologist Joel Perlmutter of Washington University in St. Louis, a member of the FDA’s expert panel for nervous system therapies, told STAT in an email that he had quit the committee on Monday “due to this ruling by the FDA without further discussion with our advisory committee.” (Joseph, 6/8)
CNBC:
Biogen Faces Tough Questions On $56K-A-Year Price Of New Alzheimer's Drug
Biogen on Tuesday faced tough questions from Wall Street analysts over the $56,000 annual cost of its newly approved Alzheimer’s drug, Aduhelm – a price tag executives are calling “fair” and “responsible.” Shares of Biogen surged 38% on Monday after the FDA announced it approved the company’s drug, scientifically known as aducanumab. It is the first medication cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades. (Lovelace Jr., 6/8)
Stat:
Biogen Isn’t Worried About Backlash To Price Of Alzheimer’s Drug
Amid a firestorm of controversy around its decision to charge $56,000 a year for an Alzheimer’s disease treatment whose benefits are disputed, Biogen defended its decision on Tuesday, pointing to lifesaving cancer therapies that can cost nearly three times as much. “We believe the price is substantiated by the value it is expected to bring to patients, caregivers, and society,” CEO Michel Vounatsos said on a triumphant conference call with Wall Street analysts. (Garde, 6/8)
Stat:
Biogen, FDA At Odds Over Timing Of Confirmatory Trial Of Alzheimer’s Drug
Biogen and the Food and Drug Administration are at odds over the timing of a confirmatory trial for the company’s newly approved drug for Alzheimer’s disease, an issue of critical importance in determining whether the medicine is delivering benefits to patients. Hours after the approval of Aduhelm on Monday, Biogen CEO Michel Vounatsos said that the company could take up to nine years to satisfy the FDA’s post-approval requirement that it conduct an entirely new clinical trial to confirm the benefit of the drug for patients with Alzheimer’s. Those remarks, made during an interview with CNBC, were not received well inside the agency because they suggested Biogen felt no urgency to complete the study in a timely manner, an FDA official said. (Feuerstein and Herper, 6/8)
Also —
Axios:
New Alzheimer's Drug Could Blow Up Health Care Spending
Biogen's new Alzheimer's treatment could be experts' nightmare drug spending scenario: An extremely expensive product that millions of desperate patients could be eligible for — and it may not even work. Alzheimer's is a devastatingly common disease with no cure. But the FDA's decision this week paved the way for a free-for-all in which taxpayers foot most of the enormous bill for a drug that hasn't been proven effective. (Owens, 6/9)
The Baltimore Sun:
There’s A New Alzheimer’s Drug, So What’s The Problem? A Johns Hopkins Doctor Explains
After years of disappointing studies of potential treatments for the more than 6 million people living with Alzheimer’s disease, the U.S. Food and Drug Administration approved a new drug Monday called aducanumab that is sure to garner significant interest. The drug, however, followed an unusual regulatory path and did not convince a key advisory panel that it works. (Cohn, 6/9)
Fox News:
Who Should Take New Alzheimer's Drug? Expert Weighs In
After the Food and Drug Administration granted approval to the first Alzheimer’s drug in nearly two decades, Biogen's Aduhelm (aducanumab), doctors are left triaging patient calls in a bid to find the appropriate patient with a mild, early course of disease. Dr. Douglas Scharre, a neurologist and director of the division of Cognitive Neurology at Ohio State Wexner Medical Center, and clinical investigator on Biogen’s studies, explains the antibody treatment works by clearing toxic amyloid proteins from brain tissue, though patients with late stage Alzheimer’s disease are unlikely to benefit. However the FDA issued a broad indication for approval. (Rivas, 6/8)
Perspectives: Is Pricey Alzheimer's Drug Worth It?
Read recent commentaries about drug-cost issues.
Stat:
Bad Medicine: Aducanumab Is A Lackluster Drug With A High Cost
Controversy has swirled around aducanumab, an experimental drug developed by Biogen, long before the FDA approved it on Monday to treat early-stage Alzheimer’s disease. The agency now finds itself under scrutiny in a situation with no good outcome. There were defensible arguments for approval, one of which is that until now there has been no disease-altering therapy to offer to individuals with Alzheimer’s or their families. (Karl Herrup and Jonathan Goulazian, 6/8)
Los Angeles Times:
This Isn't How FDA Should OK Alzheimer's Drugs
The Food and Drug Administration didn’t just make a mistake by approving a new Alzheimer’s disease drug this week. It turned what is supposed to be an objective and science-based process on its head, giving the go-ahead to a drug for which there is far more evidence that it doesn’t work than evidence that it does. Patient advocates were, of course, avid to see drugmaker Biogen’s aducanumab come to market as a potential treatment for mild stages of the dementing disease, which so far has resisted efforts to combat it. Any hope, no matter how dim, is at least something in the eyes of families who watch their loved ones deteriorate mentally and physically for years before death takes them. (6/8)
Bloomberg:
Approving Biogen's Alzheimer's Drug Aducanumab (Aduhelm) Is Big Mistake
"Follow the science" has been a consistent refrain during the pandemic, and it's usually a core mandate of the Food and Drug Administration in evaluating medicines. But when it came to one of the agency's most consequential decisions — the approval Monday of Biogen Inc.'s controversial Alzheimer's drug aducanumab — science took a back seat. Alzheimer's is a devastating illness with no treatments that do anything but ease symptoms. Biogen's drug is the first said to slow decline. If there was good evidence that it did so, it'd be a breakthrough, but the data is inconclusive at best. And while the FDA is and should be flexible when patients have no options, this decision does more than bend standards — it shatters them. (Max Nisen, 6/7)
Stat:
FDA's Aducanumab Approval Sets Stage For Bigger Breakthroughs
The Food and Drug Administration yanked the fight against Alzheimer’s out of the mire with its approval of the first disease-modifying therapy. Although it’s a modest first step, it paves the way for more momentous breakthroughs. The drug — aducanumab by Biogen and Eisai — is a monoclonal antibody that clears a toxic protein called beta-amyloid from the brain. The drug can’t reverse Alzheimer’s-related damage once amyloid has seized a beachhead and symptoms of the disease emerge. Its promise lies in battling amyloid before it does irreversible harm. (Dana Goldman and Darius Lakdawalla, 6/7)
Also —
Fox News:
Pelosi, House Democrats' Drug Pricing Bill Jeopardizes Our National Security
The lightning pace of the development and mass production of COVID-19 vaccines through Operation Warp Speed has been welcome news for hundreds of millions of Americans desperate to return to their pre-pandemic lives. More than 296 million vaccinations have already been administered with an additional 70 million more ready to go. President Donald Trump deserves credit for laying the groundwork and delivering this historic feat to the American people. His ambitious "Operation Warp Speed" enabled the pharmaceutical industry to develop and mass-produce three separate vaccines in a timeframe that the liberal media initially scoffed at with their coastal condescension. (Rep. Elise Stefanik, R-N.Y., 6/4)
The Star Tribune:
Minnesota Must Pass A Prescription Drug Affordability Board
While many issues stall in a divided Legislature, Minnesota lawmakers have had a track record of passing bills on a bipartisan basis to address the high cost of prescription drugs. From the Alec Smith Insulin Affordability Act to the Drug Price Transparency Act and pharmaceutical benefits manager reforms, we have proved that progress across party lines is possible. While negotiations continue between state leaders, I urge my colleagues on both sides of the aisle to approve a Prescription Drug Affordability Board this year. (Democratic State Rep. Kelly Morrison, 6/7)
Statesman Journal:
Don’t Let Big Pharma Buy Your Fear
When Justin, whose mother is fighting breast cancer and chronic illness, pays his bills each month, he also helps his mother prioritize her medications. This isn’t a choice either of them make willingly, but even with Justin’s financial help, the expense of sleep aids and pain management pills are often too much for the two of them to afford after filling the prescriptions that are keeping his mother alive. Determining which prescriptions they can afford is a heartbreaking, exhausting process that no Oregonian — or anyone — should have to face. Justin and his mother aren’t alone. Prescription drug prices are exceedingly high and keep climbing. According to Oregon’s 2020 Prescription Drug Price Transparency report, at least 160 drugs increased in price by 10% or more in 2019, leading to billions in revenue and hundreds of millions in profit. (Maribeth Guarino, 6/4)
Colorado Aims At Cutting Health Care Costs 15% With New Reforms
Colorado lawmakers are now requiring private insurers to offer plans that cut costs. Meanwhile, Philly's "Naked Bike Ride" will this year require masks, and a blue-green algae bloom prompts a health alert in Orange County.
Bloomberg:
Colorado Legislature Passes Health Care Plan Cutting Costs 15%
The Colorado legislature passed health reform legislation that requires private insurers to offer a state-regulated plan reducing costs by 15%, the Colorado Sun reported Tuesday. The legislature also approved a measure establishing a fee for single-use products, such as plastic and paper grocery bags, and banning Styrofoam in restaurants, the Sun reported. Colorado Governor Jared Polis, a Democrat, is expected to sign both bills. Democrats hold majorities in the Colorado House and Senate. (Del Giudice, 6/8)
Modern Healthcare:
Colorado Group Would Negotiate Healthcare Costs Directly With Hospitals
Public and private employers and two purchasing coalitions are joining forces in Colorado with the aim of cutting local healthcare costs. Larimer County and 10 other local employers—including the state of Colorado—have joined The Colorado Purchasing Alliance and Purchaser Business Group on Health to launch a regional network of excellence, with the aim of negotiating directly with health systems to set prices for common procedures. Larimer, located about an hour from Denver in northern Colorado, hopes the partnership will drop its $25 million annual healthcare costs by another 10 percentage points. (Tepper, 6/8)
In other news from Pennsylvania, Florida, Texas and California —
Fox News:
'Philly Naked Bike Ride' Participants Required To Wear Only One Item — A Face Mask
Naked bikers are set to hit the Philadelphia streets in a couple of months for an event that won't require clothing except for one specific item – a face mask. The annual Philly Naked Bike Ride is officially scheduled for Aug. 28, organizers say. The free-spirited ride – which encourages nakedness and has been labeled as a "bare as you dare" event – will require masks based on the city's earlier coronavirus restrictions. This year's event is being called: "The Mask Edition," according to promotions posted on social media. (Aaro, 6/8)
WMFE:
Blue-Green Algae Bloom Prompts Health Alert For Orlando's Lake Rowena
Toxins from blue-green algae have prompted the Orange County Health Department to issue a health alert for Lake Rowena in Orlando. State officials drew the water sample last week at the northeast corner. But the algae bloom was present throughout the lake. The public was advised not to drink the water or go swimming or boating in it. And don’t let animals near the water. (Byrnes, 6/8)
Houston Chronicle:
West Nile Virus Confirmed In Harris County Mosquito Sample
The first West Nile Virus mosquito sample of the year has been discovered in Harris County, health officials said Tuesday. Harris County Public Health’s mosquito and vector control division planned to treat the affected area in northwest Harris County where the sample was identified and collected, according to the agency. While mosquitoes are around all year, their peak activity occurs from June through October. Only a “handful” of the 56 species of mosquitoes found in Harris County transmit diseases like Saint Louis Encephalitis, Chikungunya, Dengue and Zika, according to health officials. (Serrano, 6/8)
AP:
California Worker Board To Again Reconsider Mask Standards
California’s workplace regulators are set to again reconsider controversial masking rules designed to protect employees against the coronavirus. A “special meeting” of the California Occupational Safety and Health Standards Board was hastily scheduled for Wednesday after State Health Officer Dr. Tomás Aragón sent a letter to the panel reiterating that the state plans to do away with virtually all masking and social distancing requirements for vaccinated people starting Tuesday. (Thompson, 6/9)
And high temperatures cause health concerns in Maine and Massachusetts —
Bangor Daily News:
Schools Send Kids Home For ‘Heat Days’ Using Remote Learning Developed During Pandemic
While an early heat wave caused a number of eastern Maine schools to let out students early on Monday and Tuesday, others used an approach they’ve become familiar with during the COVID-19 pandemic to let the school day go on: remote learning. The decision by three Bangor-area school districts to have students learn remotely could be a precursor for how administrators deal with extreme weather days even after the pandemic is over. Remote learning is now a viable option for district leaders faced with deciding whether to close school buildings, multiple superintendents said. (Marino Jr., 6/9)
The Boston Globe:
Cooling Centers Were Open But Few Came. Are They The Best Way To Deal With Scorchers?
It was a blistering hot day, the third in a late spring heat wave. But some of the community cooling centers the city offers its residents were all but empty. A community cooling center in the North End had no takers around noon Monday, as the thermometer hovered around 93 degrees. In Roxbury, another center had just two patrons enjoying its air-conditioned rooms. As the number of 90-degree days has steadily climbed in the area, the sparse use of the city-funded cooling centers illustrated the challenges for cities trying to help people withstand the heat — a serious health threat, particularly for the elderly. (Lusignan and Caldera, 6/8)
The Boston Globe:
Boston Teachers Union Denounces Classroom Temperatures Amid Heat Wave, Calls For Improvements To School HVAC Systems
Amid a dayslong heat wave in Massachusetts, the Boston Teachers Union said Monday temperatures reached above 80 degrees in classrooms and called for improvements to air conditioning in schools. The union on Monday posted 22 photos to a Facebook album that appeared to show temperatures of upwards of 80 degrees that were recorded inside. It wasn’t clear in which schools the photos were taken. Boston Public Schools said in a statement that officials are communicating with schools to ensure those without air conditioning systems have “two fans operating in each classroom and learning space.” (Kaufman, 6/8)
UN Says It's Time To End AIDS, Especially Since Covid Damaged Efforts
The United Nations issued a proclamation declaring the need for urgent action to end AIDS by 2030. In other news, the U.K. is sending military backup to hospitals stressed by covid surges, and E.U. lawmakers OK a type of digital vaccine passport for tourists.
AP:
UN Urges Action To End AIDS, Saying COVID-19 Hurt Progress
The U.N. General Assembly overwhelmingly approved a declaration Tuesday calling for urgent action to end AIDS by 2030, noting “with alarm” that the COVID-19 pandemic has exacerbated inequalities and pushed access to AIDS medicines, treatments and diagnosis further off track. The declaration commits the assembly’s 193 member nations to implement the 18-page document, including reducing annual new HIV infections to under 370,000 and annual AIDS-related deaths to under 250,000 by 2025. It also calls for progress toward eliminating all forms of HIV-related stigma and discrimination and for urgent work toward an HIV vaccine and a cure for AIDS. (Lederer, 6/9)
The New York Times:
A U.N. Declaration On Ending AIDS Should Have Been Easy. It Wasn’t.
The United Nations on Tuesday adopted new targets for ending AIDS as a public health threat by 2030, seemingly a goal most countries could easily have agreed to. But consensus had been elusive. In early negotiations over the agreement, called a political declaration, the United States and the European Union fought to ban policies and laws that stigmatize, or even criminalize, high-risk groups — and drastically scaled back moves to relax patent protections for H.I.V. drugs. (Mandavilli, 6/8)
In other global developments —
Bloomberg:
U.K. Sends Military To Covid Hotspots To Help Tackle Variant
The U.K. sent military personnel to hotspots in northern England to help tackle the highly transmissible delta variant of coronavirus, which is fueling a rise in cases just as ministers face a crunch decision over whether to ease lift remaining lockdown restrictions on June 21. Health Secretary Matt Hancock announced a “strengthened package of support” in Greater Manchester and Lancashire, including more testing and door-to-door visits to encourage vaccine take-up. Residents were advised to minimize travel, though officials insisted it’s not a local lockdown. (Ashton, 6/8)
CNBC:
UK Could Delay June 21 Lifting Of Covid Measures Due To Delta Variant
Despite much fanfare over its rapid vaccination program and the unlocking of coronavirus restrictions in recent months, the U.K. could be about to delay its much-vaunted lifting of all lockdown measures in England on June 21. Concerns around the “Delta” variant of the virus, the mutation originally discovered in India, have grown in recent weeks with the number of cases attributed to the variant, and hospitalizations, rising — particularly among the not-yet vaccinated and in northwest England and Scotland. (Ellyatt, 6/9)
AP:
EU Lawmakers OK Virus Pass, Boosting Summer Travel Hopes
European Union lawmakers on Wednesday endorsed a new travel certificate that will allow people to move between European countries without having to quarantine or undergo extra coronavirus tests, paving the way for the pass to start in time for summer. The widely awaited certificate is aimed at saving Europe’s travel industry and prime tourist sites from another disastrous vacation season. Key travel destinations like Greece have led the drive to have the certificate, which will have both paper and digital forms, rapidly introduced. (Cook, 6/9)
Bloomberg:
Russian Covid Cases Surge Over 10,000 For First Time Since March
New cases of Covid-19 in Russia surged over 10,000 on Wednesday to the highest in more than three months as widespread skepticism toward domestically-developed vaccines undermines attempts to corral the pandemic. The growing number of cases in Russia is unusual among countries that offer adults universal access to a vaccine, and belie official statements that the situation is nothing to worry about. (Rudnitsky, 6/9)
In news about abortion in El Salvador —
The Washington Post:
Salvadoran Woman Who Says She Lost Pregnancy In Fall Freed After Serving 9 Years On Abortion Sentence
Sara Rogel, a pregnant woman living in a village in El Salvador, was doing laundry when she slipped and fell. Her parents found her bleeding, she said, and rushed her to a nearby hospital, but she had already lost what advocates tracking her case called a “very wanted” pregnancy. Instead of consoling her, doctors contacted the police. Rogel was accused of having an illegal abortion and handcuffed to her hospital bed. She was sentenced to 30 years in prison for aggravated homicide under El Salvador’s strict abortion ban, which often catches poor women suffering obstetric emergencies in its crosshairs, according to rights groups. (Parker, 6/8)
Different Takes: Steps The G7 Must Take To End The Pandemic; Tactics To Fight Vaccine Hesitancy
Opinion writers tackle these covid and vaccine issues.
Bloomberg:
Joe Biden, Boris Johnson And The G-7 Can End The Global Pandemic
U.K. Prime Minister Boris Johnson has promised to vaccinate the world by the end of next year, saying it “would be the single greatest feat in medical history.” Sadly, a promise is not a plan, and I fear that an initiative that appears to focus on dose-sharing by nations will fall far short of delivering the worldwide herd immunity needed to make all of us safe again. Having attended 12 of them as prime minister or finance minister, I know how G-7 meetings work. They thrive on informality, which, of course, allows for plain speaking free of diplomatic niceties. (Gordon Brown, 6/9)
USA Today:
COVID Vaccine Trust Gap: Fight Hesitance With Facts And Empathy
The United States was No. 3 in the world early last month in getting at least one dose of COVID vaccine into adult arms. Even though nearly two-thirds of American adults have now received a dose, as of this week we had slipped to No. 8. How can America surge again to the top? One key is addressing the nearly 1 in 3 people who are hesitant or unsure about getting vaccinated. We all have friends and family members who have expressed concerns. (Jeremy Howard and Dr. Nick Talley, 6/9)
Newsweek:
Must We Care If You Don't Get The Shot?
I'm fully vaccinated, and so is just about everyone I know. We feel mostly protected against COVID-19. And so if others don't want to get the shot for political reasons or out of ignorance, must we care? We read that many Republicans are refusing to get the coronavirus vaccine, while most Democrats are all in. The reasoning on the right seems to be that President Joe Biden wants us all to get vaccinated, therefore they won't. Do these folks think that they are somehow offending or frustrating the opposition? (Froma Harrop, 6/8)
The Washington Post:
Thank You, Uncle Sam. The Vaccine Rollout Is The Biggest Government Success In Decades
I came of age in the 1980s as a Reagan Republican distrustful of “big government.” In 2016, I left the Republican Party, but former president Donald Trump’s unethical and incompetent conduct only further heightened my suspicion of the government. Why should I trust Washington when the previous president abused his power so badly that he was twice impeached? I am hardly alone in my skepticism. The Pew Research Center finds that the percentage of Americans who trust the federal government to do what is right has fallen from 73 percent during the Eisenhower administration to just 24 percent today. (Max Boot, 6/8)
Editorial pages discuss these various public health topics.
Modern Healthcare:
How Healthcare Can Meet Pandemic, Climate Change Challenges
The biggest challenge to human health over the next 25 years will come from climate change. It will also cause and amplify the impact of future pandemics. Both climate change and pandemics will disrupt the economic, physical and social infrastructures of countries around the world. The events of the past 18 months are a window into our future. Preemptive and adaptive policies and strategies will be needed to avoid even worse consequences than we have experienced to date. The U.S. healthcare system could play a seminal role in addressing these twin threats. To do so, healthcare leaders must reinvent what constitutes the healthcare infrastructure; accelerate the implementation of population health budgets that encourage prevention and continuously improving care; and adopt new business models. (Stephen M. Shortell, 6/8)
Stat:
Pediatrics Board Should Modernize Its Maternity Leave Policy
When my daughter started to reveal just how comfortable she was in utero, and wasn’t planning to leave any time soon, I immediately messaged my obstetrician: “I need to be induced.” I was worried about having enough leave from my fellowship in adolescent medicine. She scheduled me for an induction within a few days, nodding kindly as she shared with me that she, too, went past her due date and watched her maternity leave tick away. (Megana Dwarakanath, 6/9)
Houston Chronicle:
Sex Ed In First Grade? Knowledge Protects Kids From Abuse.
The elite Dalton School in New York City made national headlines this week after an animated sexual education video used by teachers began to circulate online. While sex education usually comes with a parallel course in managing controversy, this specific video garnered an unusual amount of outrage because of the intended audience — kids in first grade. As a psychologist who works mostly with children, especially children who have survived sexual trauma, I understand where this outrage comes. Nobody wants to think that their innocent youngster needs to know about sex. Nevertheless, I feel the need to push back. (Melissa Goldberg Mintz, 6/9)
The New York Times:
3 Lessons The AIDS Pandemic Taught Us About Covid
Forty years ago last week, the Centers for Disease Control and Prevention reported five cases of a rare pneumonia in Los Angeles that it described as “unusual”: The patients were all young, previously healthy “active homosexuals” whose immune systems had inexplicably stopped working. Two had died by the time of the report’s publication, and the other three died soon after. It was, unbeknown to the C.D.C., the first official U.S. recognition of the disease now called AIDS: one of the worst pandemics in human history that has since killed nearly 35 million people, including over 700,000 Americans. (Spencer Bokat-Lindell, 6/8)
The Baltimore Sun:
Letting Incarcerated Cancer Patient Out Of Prison Would Show Mercy And Still Uphold Justice
There are things to think about that are unquestionably more beautiful and uplifting than the plight of a 64-year-old prison inmate with advanced liver cancer. I could use this space to describe the trill of a thrush I heard Sunday evening in the woodlands along the Gunpowder River. I could tell you about the kaleidoscope of butterflies that suddenly rose from the trail during our hike, or the spooky mist that appeared on the river at sunset. But, as much as I would prefer to contemplate things of beauty in a world so often ugly and upside down, I come to Robert Smith because, even at the far end of society’s spectrum, among the scorned and forgotten, there’s the possibility of mercy. (Dan Rodricks, 6/8)