First Edition: July 30, 2021
Today's early morning highlights from the major news organizations.
KHN:
Diabetes Drug’s New Weight Loss Formula Fuels Cost-Benefit Debate
The long list of side effects that follow ads for the newer expensive drugs to treat Type 2 diabetes sometimes include an unusual warning: They might cause weight loss. That side effect is one that many people — especially those with Type 2 diabetes, which is associated with obesity — may desperately want. So it’s no surprise that some of the same drugs are being reformulated and renamed by manufacturers as a new obesity treatment. No longer limited to the crowded field of treatments for Type 2 diabetes, which affects about 10% of Americans, they join the far smaller number of drugs for obesity, which affects 42% of Americans and is ready to be mined for profit. (Appleby, 7/30)
KHN:
Amid Covid Booster Debate, West Virginia To Check Immunity Of Vaccinated Nursing Home Residents
West Virginia raced ahead of the country last winter to get people in nursing homes vaccinated against covid-19, but with cases and hospitalizations on the rise again, state officials want to know whether immunity levels are falling for residents who had their shots. Starting in August, the state plans to begin measuring the levels of disease-fighting antibodies in the blood of vaccinated nursing home residents, which could help indicate whether they need a booster shot. The process will be voluntary and the data will be shared with federal health agencies evaluating the need for boosters. (Galewitz, 7/30)
KHN:
Bus Stop By Bus Stop, Denver-Area Officials Microtarget Vaccine Hesitancy
John Letson had seen too many apocalyptic movies to feel comfortable getting a covid-19 vaccine initially. “I was completely against it,” the 40-year-old movie buff said, referencing “I Am Legend” and “Children of Men,” in which humanity is in jeopardy, as examples of what could go wrong. “I think an untested thing during a pandemic has later effects that we don’t know yet.” (Hawryluk, 7/30)
KHN:
KHN’s ‘What The Health?’: Hot Covid Summer
Predictions of a “hot vax summer” that would let Americans who had their covid immunizations celebrate the waning of the pandemic are turning out to have been premature. Covid-19’s delta variant is driving up cases in all 50 states, prompting new recommendations for masks and a growing number of vaccine requirements, including one for most federal workers. Meanwhile, official Washington celebrated the anniversary of the 1990 Americans with Disabilities Act, which sought to guarantee an array of protections, as concerns grow that people with covid aftereffects could dramatically expand the population needing those protections. (7/29)
CNN:
CDC Document Warns Delta Variant Appears To Spread As Easily As Chicken Pox And Cause More Severe Infection
CDC Director Dr. Rochelle Walensky confirmed the authenticity of the document, which was first reported by The Washington Post. "I think people need to understand that we're not crying wolf here. This is serious," she told CNN. "It's one of the most transmissible viruses we know about. Measles, chickenpox, this -- they're all up there." The CDC is scheduled to publish data Friday that will back Walensky's controversial decision to change guidance for fully vaccinated people. She said Tuesday the CDC was recommending that even fully vaccinated people wear masks indoors in places where transmission of the virus is sustained or high. (LeBlanc, Fox and Cohen, 7/29)
The New York Times:
C.D.C. Internal Report Calls Delta Variant As Contagious As Chickenpox
Dr. Rochelle P. Walensky, the director of the agency, acknowledged on Tuesday that vaccinated people with so-called breakthrough infections of the Delta variant carry just as much virus in the nose and throat as unvaccinated people, and may spread it just as readily, if less often. But the internal document lays out a broader and even grimmer view of the variant. The Delta variant is more transmissible than the viruses that cause MERS, SARS, Ebola, the common cold, the seasonal flu and smallpox, and it is as contagious as chickenpox, according to the document, a copy of which was obtained by The New York Times. (Mandavilli, 7/30)
The Washington Post:
‘The War Has Changed’: Internal CDC Document Urges New Messaging, Warns Delta Infections Likely More Severe
The delta variant of the coronavirus appears to cause more severe illness than earlier variants and spreads as easily as chickenpox, according to an internal federal health document that argues officials must “acknowledge the war has changed.” The document is an internal Centers for Disease Control and Prevention slide presentation, shared within the CDC and obtained by The Washington Post. It captures the struggle of the nation’s top public health agency to persuade the public to embrace vaccination and prevention measures, including mask-wearing, as cases surge across the United States and new research suggests vaccinated people can spread the virus. (Abutaleb, Johnson and Achenbach, 7/29)
The New York Times:
How Often Do The Vaccinated Spread Covid-19?
The recommendation that vaccinated people in some parts of the country dust off their masks was based largely on one troublesome finding, according to Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention. New research showed that vaccinated people infected with the Delta variant carry tremendous amounts of the virus in the nose and throat, she said in an email responding to questions from The New York Times. (Mandavilli, 7/29)
ABC News:
US Approaching Same Case Numbers As 1 Year Ago
The United States is facing a COVID-19 surge this summer as the more contagious delta variant spreads. More than 612,000 Americans have died from COVID-19 and over 4.1 million people have died worldwide, according to real-time data compiled by the Center for Systems Science and Engineering at Johns Hopkins University. (Shapiro, Pereira, Deliso and Winsor, 7/30)
AP:
Biden Orders Tough New Vaccination Rules For Federal Workers
President Joe Biden has announced sweeping new pandemic requirements aimed at boosting vaccination rates for millions of federal workers and contractors as he lamented the “American tragedy” of rising-yet-preventable deaths among the unvaccinated. Federal workers will be required to sign forms attesting they’ve been vaccinated against the coronavirus or else comply with new rules on mandatory masking, weekly testing, distancing and more. The strict new guidelines are aimed at increasing sluggish vaccination rates among the huge number of Americans who draw federal paychecks — and to set an example for private employers around the country. (Jaffe, Alonso-Zaldivar and Lemire, 7/30)
The Washington Post:
Biden Tells Federal Workers To Get Vaccinated Or Face Restrictions
“I think you’re going to find the patience of businesses, and the patience of other people, running thin,” Biden said, his voice at times rising in exasperation. “Because the fact is, if we had a higher vaccination rate, we wouldn’t be in this position.” He added, “If in fact you are unvaccinated, you present a problem — to yourself, to your family, and to those with whom you work. . . . You want to know how we put this virus behind us? I’ll tell you how. We need to get more people vaccinated.” (Linskey, Wagner and Kim, 7/29)
Politico:
Biden Rolls Out Aggressive Plan To Jump-Start Vaccination
Biden also called on state, territorial and local governments to use coronavirus relief funding to offer $100 to anyone who gets a shot. Polling and anecdotal evidence shows cash incentives have motivated some unvaccinated Americans to roll up their sleeves. The President announced that small- and medium-sized businesses will now be reimbursed for offering their employees paid leave to get their family members, including their kids, vaccinated. In April, the President announced that, thanks to the American Rescue Plan, the federal government is fully reimbursing any small- or medium-sized business that provides workers with paid time off to get vaccinated. (Gardner, 7/29)
Stat:
Biden Wants $100 Rewards For Covid Vaccines. But Will States Pay?
President Biden wants states to give $100 to people who get vaccinated against Covid-19. He wants to require federal workers to get immunized. He wants the same for members of the military, too. It remains entirely unclear, however, whether he has the power to achieve those goals. (Facher, 7/29)
ABC News:
Biden's Vaccine Requirement Could 'Very Well' Require Troops To Get The Shot
New vaccine requirements for federal employees expected to be announced by President Joe Biden Thursday "very well" could mean troops will be required to get the shot, a senior Pentagon official told ABC News on Wednesday. But if not, it still may only be a matter of time. Because COVID-19 vaccines are available to the military under the Food and Drug Administration's emergency use authorization (EUA), the shot has so far been strictly voluntary. (Seyler, 7/29)
The Hill:
Pentagon Says It Will Start Talks On Making COVID-19 Vaccine Mandatory
The Pentagon said Thursday it will begin internal talks on making the coronavirus vaccine mandatory for military personnel, after President Biden called on defense leaders to examine "how and when" to mandate the vaccine for U.S. troops.“ Secretary Austin will also begin consulting our medical professionals, as well as the Joint Chiefs of Staff, to determine how and when to make recommendations to the President with respect to adding the COVID-19 vaccines to the full list of requirements for military personnel,” deputy Pentagon press secretary Jamal Brown said in a statement Thursday evening. (Lonas, 7/29)
The Hill:
Capitol Police Asked To Arrest The Maskless
Congressional aides and visitors to the House side of the Capitol will face arrest if they're not wearing masks, the head of the U.S. Capitol Police announced this week. In a Wednesday letter to his officer corps, Capitol Police Chief Thomas Manger ordered that they enforce the new mask guidelines across the Capitol complex. Those new rules, installed by the Capitol physician earlier in the week, include a mask mandate on the House side of the Capitol and all House office buildings. (Lillis, 7/29)
The Hill:
House GOP Stages Mask Mandate Protest
Nearly 40 maskless House Republican lawmakers walked across the Capitol and onto the Senate floor in protest of the Capitol physician’s decision to reinstate a mask mandate in the lower chamber but not in the upper chamber. Republicans complained that the policy, backed by Speaker Nancy Pelosi (D-Calif.) and other Democrats, is inconsistent, infringes on personal liberty, and is based on politics, not science. (Wong, 7/29)
AP:
Biden To Allow Eviction Moratorium To Expire Saturday
The Biden administration announced Thursday it will allow a nationwide ban on evictions to expire Saturday, arguing that its hands are tied after the Supreme Court signaled the moratorium would only be extended until the end of the month. The White House said President Joe Biden would have liked to extend the federal eviction moratorium due to spread of the highly contagious delta variant of the coronavirus. Instead, Biden called on “Congress to extend the eviction moratorium to protect such vulnerable renters and their families without delay.” (Casey, 7/30)
Politico:
Democrats At Odds Over Extending Eviction Ban Despite Biden Plea
House Democratic leadership on Thursday struggled to build support for a five-month extension of the nationwide eviction moratorium that's set to lapse this weekend after running into opposition from more than a dozen Democratic lawmakers, according to two sources familiar with the situation. With the ban set to expire Saturday and millions of Americans at risk of losing their homes, House Majority Leader Steny Hoyer (D-Md.) confirmed that Democrats in favor of extending the moratorium were still working to lock down backing for a possible last-minute vote Friday. The House is set to leave town at the end of this week until September. (O'Donnell, 7/29)
AP:
Nevada Officials: Renters Have Path To Avoid Quick Evictions
Money is available for tenants who could face eviction as early as this weekend as pandemic protections expire, and Nevada’s governor and advocates called Thursday for affected renters to quickly contact programs set up to help. “We will see landlords evicting tenants for non-payment of rent,” and courts may be flooded, said Bailey Bortolin, director of the Nevada Coalition of Legal Service Providers and a board member at the Legal Aid Center of Southern Nevada. The center encourages property owners to work with renters through a coronavirus relief housing assistance program, commonly known as CHAP. (Ritter, 7/30)
AP:
U.S. Jobless Claims Down 24,000 To 400,000 As Economy Recovers
The number of Americans collecting unemployment benefits slid last week, another sign that the job market continues to recover rapidly from the coronavirus recession. Jobless claims dropped by 24,000 to 400,000 last week, the Labor Department reported Thursday. (7/29)
The New York Times:
Biden Signals Support For Democrats’ Plan To Advance Immigration Changes Unilaterally, Via A Budget Bill.
President Biden said on Thursday night that he supported a plan championed by congressional Democrats to use a legislative process intended for budget-related measures to bypass Republican opposition and legalize millions of undocumented immigrants. Senator Chuck Schumer, Democrat of New York and the majority leader, has been quietly exploring whether it would be possible to attach a broad revision of immigration laws to a $3.5 trillion budget plan that Democrats intend to pass unilaterally through a fast-track process known as budget reconciliation. (Karni, 7/29)
The New York Times:
Biden To Meet With Top Democrats On New Voting Rights Proposal
President Biden and the top Democrats in Congress are expected to meet at the White House on Friday to discuss their party’s faltering efforts to pass major voting rights legislation, according to two congressional aides familiar with the plans. Mr. Biden’s meeting with Speaker Nancy Pelosi of California and Senator Chuck Schumer of New York comes at a crucial moment, as activists are pushing the president to use his power and Democrats’ control of Congress to protect voting rights while they have the chance. Republican-led states have enacted at least 30 new laws containing a host of new restrictions on voting, and G.O.P. senators have blocked consideration of a Democratic bill that would impose sweeping new federal mandates aimed at overriding them. (Fandos and Corasaniti, 7/29)
Politico:
Schumer Says He Has Votes For Moving $3.5 Trillion Package
Senate Majority Leader Chuck Schumer said Thursday that all 50 Democrats will vote to move forward on the party’s $3.5 trillion social spending proposal. Schumer’s remarks come after the Senate took the first step to advance a $550 billion bipartisan infrastructure framework Wednesday evening. The New York Democrat has long insisted that the Senate will pass both the bipartisan bill and a budget blueprint for the multitrillion-dollar legislative package before the chamber leaves for the August recess. (Levine, 7/29)
The Washington Post:
Schumer Faces Key Test On Infrastructure And Biden Agenda
Just hours after Georgia voters elected two Democrats, flipping the Senate majority, on Jan. 5, Sen. Charles E. Schumer reveled in the victory and said his caucus — handed power for the first time in six years — was “committed to delivering the bold change and help that Americans need and demand.” In the months since, Schumer has repeatedly promised “big and bold” solutions to the problems ailing America. He now may be on the cusp of delivering them amid his most perilous test of leadership yet, with a bipartisan infrastructure deal moving closer to fruition, a multi-trillion-dollar economic and social policy plan waiting in the wings, and the fate of President Biden’s governing agenda hanging in the balance. (DeBonis, 7/29)
CNBC:
Jill Biden Had A Sharp Object Removed From Her Foot At The Hospital
First Lady Dr. Jill Biden had a sharp object removed from her left foot by doctors at Walter Reed National Military Medical Center on Thursday, her office said. “Last weekend, prior to her two official events in Hawaii, the First Lady stepped on an object on the beach which became lodged in her left foot,” said spokesman Michael LaRosa. LaRosa said Biden underwent “a procedure today at [Walter Reed] to remove the object.” (Wilkie, 7/29)
Modern Healthcare:
CMS Announces Medicare Pay Hikes For Providers
The latest Medicare payment rules for inpatient rehabilitation, inpatient psychiatric, hospices and skilled nursing facilities are out, and there's good news for those healthcare providers. Under a final rule CMS published Thursday, inpatient rehab facilities will get a 1.9% pay bump in 2022, raising their reimbursements by $130 million. Inpatient psychiatric facilities will get a 2% hike, an increase of $80 million. Hospices also will get paid 2% more, which amounts to an additional $480 million. Skilled nursing facilities will get a rate increase just over 1%, or $410 million. (Brady, 7/29)
Modern Healthcare:
Insurers Oppose Longer Marketplace Open Enrollment Period
Health insurance companies are pushing back against President Joe Biden's plan to lengthen the annual open enrollment period on the exchanges, according to comments the trade group AHIP made on a proposed regulation. CMS published a draft rule last month that would give consumers 30 extra days to sign up and establish monthly special enrollment periods for low-income people to enroll in subsidized low-cost or no-cost health plans. Comments on the regulation closed Wednesday. (Brady, 7/29)
Reuters:
CDC Says Americans Should Wear Masks In Nearly 70% Of U.S. Counties
The Centers for Disease Control and Prevention (CDC) said on Thursday that 69.3% of U.S. counties had transmission rates of COVID-19 high enough to warrant indoor masking in public spaces and should immediately resume the policy. The transmission rate was up from 66.6% as of Wednesday. In total, 52.2% of U.S. counties have high COVID-19 community transmission rates and 17.1% have substantial rates, the CDC said. (Shepardson, 7/29)
The Washington Post:
D.C. Requires Masks Again As Covid Cases Rise
Masks will again be required indoors in D.C. beginning Saturday, Mayor Muriel E. Bowser ordered, in a reversal of recent policy driven by new federal guidelines that recommend indoor masking in areas where coronavirus transmission is high. The new requirement, which Bowser (D) announced Thursday, will apply to vaccinated and unvaccinated people over the age of 2. (Zauzmer and Elwood, 7/29)
The Washington Post:
Smithsonian To Require All Visitors To Wear Masks Indoors Starting Friday, Even If They’re Vaccinated
Starting Friday, all visitors — even those who are vaccinated — must wear masks at the Smithsonian Institution’s museums and indoor spaces, it said Thursday. The move is a reversal from the Smithsonian’s announcement last month that visitors who have been vaccinated didn’t need to wear masks indoors. (Hedgpeth, 7/29)
Politico:
Florida Officials Defy DeSantis As Infections Spike
Florida’s Covid wars are starting again. Local officials across Florida are bucking Gov. Ron DeSantis and his anti-mandate coronavirus strategy as infections soar in the state and nation. They’re imposing vaccine and mask requirements for government workers and even declaring states of emergency. In a sign of how worrisome the new Covid-19 surge is, Disney World is ordering all guests over 2-years-old to wear masks indoors at its Florida theme park, regardless of vaccination status. (Dixon, 7/29)
CNBC:
Texas Gov. Abbott Doubles Down Against Covid Health Limits
Texas Gov. Greg Abbott issued an executive order Thursday, reiterating his opposition to mask mandates, Covid-related business restrictions and vaccination requirements and issuing fines of up to $1,000 on those who fail to comply. The governor also called on state hospitals to deliver daily reports on their capacity to the Texas Department of State Health Services to send to the Centers for Disease Control and Prevention. (Towey, 7/29)
AP:
Officials: Renewed Mask Mandate Frustrating But Necessary
Nevada health officials said Thursday that they understand the return of an indoor mask mandate is frustrating but that it’s a necessary step to protect people as the number of coronavirus infections rises. “Many may feel over having to put a mask back on. We don’t like it either,” said Candice McDaniel, a director in Nevada’s health department. (Price, 7/30)
The Washington Post:
St. Louis Public Health Leader Said A Mob Called Him Racist Slurs For Promoting Masks: ‘We Are Not The Enemy’
When Faisal Khan left the St. Louis County council meeting Tuesday after promoting a new mask mandate, he said he was shoulder-bumped and pushed by people in the aisle. When he made it through the door, the St. Louis County Department of Health’s acting director said things got worse. Khan was surrounded by an “angry mob,” he said, and called an expletive and a brown b-----d. Others mocked his accent. (Harkins, 7/29)
AP:
Renewed Indoor Mask Guidance Applies To Only 1 Maine County
New federal guidance that everyone wear face coverings indoors in areas of high or substantial transmission applied to only one county in Maine on Friday. ... The CDC rates counties as “low,” “moderate,” “substantial” or “high” based on their level of community transmission. Every county in Maine was listed as moderate except Waldo County, which was listed substantial. (7/30)
AP:
Beshear Updates School Mask Recommendations
Schools should make sure to require indoor mask wearing for all teachers, staff, students and visitors to K-12 schools, regardless of vaccination status, Kentucky Gov. Andy Beshear said. Administrators should have layered strategies in place to prevent COVID-19 infection and transmission, he added Thursday. (7/30)
The Washington Post:
More Washington Area Schools Will Mandate Masks In The Fall
Schools will open this fall in much of the Washington region a little less normal than expected — with mask requirements now planned for Fairfax and Arlington counties, along with D.C. and Montgomery and Prince George’s counties. School systems are issuing the mandates regardless of vaccination status — to the relief of some families and teachers, and to the dismay of others. (St. George and Stein, 7/29)
The Washington Post:
As New School Year Looms, Debates Over Mask Mandates Stir Anger And Confusion
New federal guidelines prompted by a surge in coronavirus cases have left school leaders across the country embroiled in debates over whether to require masks in schools, muddling a long-sought return to normalcy for millions of children. The wrangling over masks, considered by pediatricians and epidemiologists to be one of the most effective ways to stop school spread, has turned deeply personal and political, fueling vitriol at school board meetings that have left board members fearing for their safety. Several Republican-led states have barred school districts from requiring masks, threatening to fine school leaders or cut state funding if they attempt it. (Balingit, St. George and Strauss, 7/29)
CBS News:
Summer Camps See Rise In COVID-19 Outbreaks Ahead Of New School Year
The U.S. has seen a wave of COVID-19 outbreaks linked to summer camps and health officials fear it could be a preview of what's to come in the new school year. In rural Hudson, New York, where 67% of those 12 and up are fully vaccinated, news of a COVID-19 outbreak at nearby Camp Pontiac has rattled the community. "By Monday, it was 23," said Jack Mabb, the health director of Columbia County. "By Wednesday, it was 31, all in the seven to 11 age group. So they're of course unvaccinated." "Our reaction is we haven't seen this," he said. (Battiste, 7/29)
Newsweek:
Uber Joins Facebook, Google Requiring Employees Returning To Offices To Be Vaccinated
Uber announced Thursday that its employees must be fully vaccinated as the rideshare company plans its return to the office for this October. The announcement comes a day after other Big Tech companies, including Google, Twitter and Facebook said their employees must receive the vaccination in order to enter the office. (Rouhandeh, 7/29)
AP:
States Race To Use COVID-19 Vaccines Before They Expire
Hundreds of thousands of COVID-19 vaccine doses have been saved from the trash after U.S. regulators extended their expiration date for a second time, part of a nationwide effort to salvage expiring shots to battle the nation’s summer surge in infections. The Food and Drug Administration on Wednesday sent a letter to shot maker Johnson & Johnson declaring that the doses remain safe and effective for at least six months when properly stored. The FDA’s move gives the shots an extra six weeks as public officials press more Americans to get inoculated. (Catalini, 7/30)
The Washington Post:
Johnson & Johnson Vaccine Production Restarts In Baltimore But Still Not Cleared For Distribution
Emergent BioSolutions said Thursday it has received the go-ahead from the Food and Drug Administration to resume manufacturing Johnson & Johnson coronavirus vaccine after a suspension of more than 100 days because of cross-contamination at its Baltimore factory. The company still does not have full FDA approval that would allow any bulk vaccine produced there to be distributed in the United States without additional reviews, but the company called the restart an important step toward getting the only domestic source of Johnson & Johnson’s single-shot vaccine back on track. (Rowland, 7/29)
CNN:
As Louisiana Faces A Covid-19 Surge, One Unvaccinated Patient Says: 'I Am Furious With Myself'
Sitting in her hospital room in Baton Rouge, Louisiana, Aimee Matzen struggled to breathe as she described how exhausting it is to have Covid-19. "The fact that I am here now, I am furious with myself," she told CNN between deep, deliberate breaths. "Because I was not vaccinated." Matzen, 44, finds herself in the Covid-19 intensive care unit at Our Lady of the Lake Regional Medical Center in Baton Rouge. She is receiving oxygen treatments and hopes she stays well enough to avoid getting hooked up to a ventilator. (Marquez, Andone and Boxer, 7/29)
The Washington Post:
Covid May Lead To Cognitive Decline, Research Says
Preliminary research presented at the Alzheimer’s Association International Conference in Denver this week suggests that coronavirus infections might lead to lasting cognitive impairment, especially among older people. But Heather M. Snyder, the Alzheimer’s Association’s vice president of medical and scientific relations, cautioned that while the findings from three studies are a step toward understanding how covid-19 affects the brain, more research is needed. (Haupt, 7/29)
CIDRAP:
Treated MIS-C Shows Favorable Follow-Up At 6 Months, Study Says
In a longitudinal cohort of 25 children with multisystem inflammatory syndrome in children (MIS-C), all were asymptomatic and at their functional baseline at 6-month follow-up, according to a Pediatrics study yesterday. The study included a total of 50 children, with some lost to follow-up, but during all intermediary follow-ups, symptoms were improving. All study participants were admitted to Cohen Children's Medical Center with MIS-C from Apr 17 to Jun 20, 2020 (median age, 8.5 years; range, 9 months to 17 years). Most patients exhibited rapid clinical improvement, with an average hospital stay of 5 days. At discharge, 69% of 26 patients with left ventricular (LV) systolic dysfunction had resumed normal function, 15% had persistent but improved dysfunction, and 15% had mild dysfunction at admission but no available discharge data. (7/29)
Newsweek:
Dr. Stella Immanuel, Hydroxychloroquine Advocate, Sues CNN, Anderson Cooper For $100M
The Texas doctor who became famous in 2020 for promoting the use of Hydroxychloroquine [HQC], an anti-malarial drug, as "a cure" for COVID-19 has filed a defamation lawsuit against CNN and CNN anchor, Anderson Cooper in the amount of $100 million. Dr. Stella Immanuel filed a federal lawsuit on Tuesday claiming that, "in an effort to vilify, demonize and embarrass President [Donald] Trump, Cooper and CNN published a series of statements of fact about Dr. Immanuel that injured her reputation and exposed her to public hatred, contempt, ridicule, and financial injury." (Pedroja, 7/29)
Stat:
FDA Threatens To Fine Drug Maker For Failing To Report Clinical Trial Results
For only the second time, the Food and Drug Administration is threatening to fine a drug maker for failing to submit required information about a clinical trial to a U.S. government registry. In a July 26 letter, the agency noted results of Phase 2 clinical test of a drug for treating acne rosacea had not been posted, even though the FDA contacted Accuitis last October about the issue. Acne rosacea is a condition that causes pus-filled bumps on the face and mostly affects middle-aged women with fair skin. Accuitis now has until Aug. 26 to post the data. (Silverman, 7/29)
Stat:
Congress Presses The FDA To Move Faster On ALS Drugs
Lawmakers pressed a top Food and Drug Administration official Thursday for answers on why the agency has balked at approving medicines to treat the fatal neurodegenerative condition ALS. Two key politicians even called out specific drug candidates by name, a rare congressional boost for the biotechs behind them. The questions came during a hearing on neurodegenerative diseases hosted by the House Energy and Commerce committee that featured testimony from the National Institutes of Health, as well as patients and caregivers for conditions like Huntington’s disease and Alzheimer’s. But the lion’s share of questions were directed to the FDA’s drug center chief, Patrizia Cavazzoni. And most were about ALS. (Florko, 7/29)
NPR:
The Feds Are Making PrEP Free. But You May Still Have To Pay To Get It
The federal government is making it much easier for Americans to get their hands on a potentially life saving treatment, if you have health insurance. It's called PrEP, a once-daily pill that is 99% effective at preventing HIV infections. PrEP has been around for nearly a decade, and health officials have long advocated for high risk people to take it, but usage has been limited due to the costs. Truvada, one of the medications authorized for PrEP, recently went generic, but used to cost upwards of $1,800 a month. The doctor's visits and lab tests can cost hundreds more. (Saloway and Benk, 7/29)
NPR:
Ambitious Plan To Stem HIV/AIDS Epidemic Meets None Of Its Goals
In 2015, global groups set ambitious goals to stem the HIV/AIDS epidemic. They aimed to bring down the number of new cases, particularly among children, teens and young women, by 2020 – and to bring up the number of people on HIV treatment. On July 21, the final report came out. No targets were met. (Wu, 7/29)
CIDRAP:
Prepackaged Salad Recall Expands In 3-State Salmonella Outbreak
Bright Farms yesterday expanded its recall of packaged salad greens that have been linked to a Salmonella outbreak that has now sickened 11 people in 3 states, according to federal health officials. The recall involves products packaged at its Rochelle, Ill., facility and were sold in Illinois, Iowa, Indiana, and Michigan, the Food and Drug Administration (FDA) said in a recall update. In addition to several products that were subject to a Jul 15 recall, the expansion yesterday includes baby spinach that was sold in 4- and 8-ounce packages. The product is past its expiration date. The expiration date for the previously recalled products is today. (7/29)
The Washington Post:
Coffee Doesn't Increase Risk Of Arrhythmia, Study Finds
If you’ve been told to avoid coffee because it might make your heart beat irregularly, recent research suggests it may be time to rethink that recommendation. “There’s this quite pervasive conventional wisdom” that people who have or are at risk of arrhythmias, or abnormal heart rhythms, should avoid caffeine, said Gregory Marcus, a cardiologist and professor of medicine at the University of California at San Francisco. Many patients who come to see him have already been told by other doctors to steer clear of caffeinated products, such as coffee, he said. (Chiu, 7/29)
Stat:
States Will Have To Decide Exactly How To Spend Opioid Settlement Money
The endgame of the sprawling mass of opioid lawsuits is starting to come into focus: Already, a settlement with Johnson & Johnson and three major drug distributors will pour billions of dollars into communities to combat the addiction crisis, with more to come. But what that looks like, exactly, will vary from place to place. States are likely to see lump sums of money doled out for years, and they will be left to decide how to spend it under the guideposts set up in the settlements. (Joseph, 7/30)
NPR:
Was It 'Reasonable' To Ship 81 Million Opioid Pills To This Small West Virginia City?
The outcome of a landmark federal opioid trial in West Virginia that reached closing arguments this week rests on two legally thorny questions. Was it "unreasonable" for three of America's biggest corporations — the drug wholesalers AmerisourceBergen, Cardinal Health and McKesson — to ship roughly 81 million highly addictive opioid pills to pharmacies in one small Rust Belt city on the Ohio River? (Mann, 7/30)
Stat:
Siloed Overdose Data Pose Challenges For Researchers
As fatal overdoses once again rise — accounting for 92,183 deaths in 2020, a 30% increase from the year before — public health researchers are racing to develop better tools to prevent them. Some see promise in models that pull in data and spit out predictions about who is at highest risk of developing opioid use disorder or overdosing, giving health officials and physicians an idea of where to target strained prevention resources. But experts say that a scattered and siloed system to collect data on overdoses and outcomes is hamstringing efforts to further develop and deploy those models. (Lin, 7/30)
AP:
2 Rail Conductors Among 3 Charged With Prescription Scheme
Two New Jersey Transit conductors, including one who sits on the board of directors, took part in a fraud scheme involving expensive prescription drugs, according to charges announced Thursday by the Essex County prosecutor’s office. ... According to federal authorities involved in the larger probe, the scheme exploited the fact that some New Jersey state and local government employees had insurance that covered expensive compound medications such as pain, scar, antifungal and libido creams. Reimbursements ran as high as thousands of dollars for a one-month supply. Conspirators recruited government employees like teachers, police and firefighters to submit claims for prescriptions, based solely on the amount of money the insurance company would pay for them. (Porter, 7/30)
AP:
Illinois Reports Winners Of 55 Marijuana Licenses In Lottery
There are 55 winners of Illinois’ lottery for licenses to operate marijuana retail stores officials said Thursday, but the licenses can’t be awarded until a judge rules on a challenge to the process. Awarding of the licenses by the Illinois Department of Professional Regulation have been delayed for more than a year, initially because of COVID-19-related issues. Problems with scoring the applications added to the delay. (7/30)
The New York Times:
Fourth Suicide At The Vessel Leads To Calls For Higher Barriers
Just two months after the Vessel, a honeycomb-like spiral of staircases in Hudson Yards, reopened with design changes meant to lower the risk of suicides, a 14-year-old boy died by suicide there on Thursday afternoon, the police said. The death, which was the fourth suicide at the tourist attraction in a year and a half, angered community members who have repeatedly called on developers to build higher barriers on the walkways and raised questions about the effectiveness of the structure’s suicide-prevention methods. (Wong and Gold, 7/29)
AP:
Japan Expands Virus Emergency After Record Spikes Amid Games
Japan expanded a coronavirus state of emergency to four more areas in addition to Tokyo on Friday following record spikes in infections as the capital hosts the Olympics. Prime Minister Yoshihide Suga declared an emergency in Saitama, Kanagawa and Chiba, near Tokyo, as well as in the western city of Osaka, effective Monday until Aug. 31. Emergency measures already in place in Tokyo and the southern island of Okinawa will be extended until the end of August, after the Olympics and well into the Paralympics which start Aug. 24. (Yamaguchi, 7/30 )