- KFF Health News Original Stories 4
- Investigation: This Dental Device Was Sold to Fix Patients’ Jaws. Lawsuits Claim It Wrecked Their Teeth.
- Biden Promises to Fight GOP on ‘Gutting’ Medicaid. Budget Talks Seem Like Another Story.
- Idaho Dropped Thousands From Medicaid in the Pandemic’s First Years
- Listen to the Latest 'KFF Health News Minute'
- Covid-19 2
- Covid Vaccine Maker Novavax Warns It May Go Out Of Business
- Coronavirus 'Lab Leak' Theory Supported By FBI Director
From KFF Health News - Latest Stories:
KFF Health News Original Stories
A dental device called AGGA has been used on about 10,000 patients without FDA approval or proof that it works. In lawsuits, patients report irreparable harm. The AGGA’s inventor and manufacturer have denied all liability in court. (Brett Kelman and Anna Werner, CBS News, 3/1)
Biden Promises to Fight GOP on ‘Gutting’ Medicaid. Budget Talks Seem Like Another Story.
As many lower-income Americans prepare to lose pandemic-era access to Medicaid, President Joe Biden vowed to stop Republicans from making deeper cuts to lower the national debt. Other changes may still be up for discussion. (Michael McAuliff, 3/1)
Idaho Dropped Thousands From Medicaid in the Pandemic’s First Years
The removals, detailed in emails between state and federal health officials, hinged on disagreements over how states could disenroll people during the public health emergency. Consumer advocates fear the alleged violation signals the mess to come on April 1, when the pandemic-era Medicaid coverage mandate ends. (Rachana Pradhan, 3/1)
Listen to the Latest 'KFF Health News Minute'
“Health Minute” brings original health care and health policy reporting from the KFF Health News newsroom to the airwaves each week. (1/2)
Summaries Of The News:
Lilly Slashing Price Of Insulin By 70%, Will Cap Monthly Costs At $35
The company said the changes take effect immediately and include two of its most popular drugs, Humalog and Humulin. The move comes on the heels of President Joe Biden's State of the Union speech last month that pressed for the $35 monthly cap to be expanded beyond Medicare to include every diabetes patient.
The Wall Street Journal:
Eli Lilly To Cut Prices Of Insulin Drugs By 70%
Eli Lilly & Co., facing pressure to curb diabetes-treatment costs, will cut the list prices for its most commonly prescribed insulin products by 70% and take other steps to make it easier for patients to afford the drugs. The Indianapolis-based company said Wednesday the 70% price cuts will take effect in the fourth quarter for Humalog and Humulin, its two biggest-selling insulin products. (Loftus, 3/1)
Forbes:
Eli Lilly Slashes Insulin Prices Up To 70% And Caps Out-Of-Pocket Costs To $35
As part of today’s announcement, Lilly said that it will automatically cap the out-of-pocket costs for its insulin products at $35 a month for those with commercial insurance. Patients without insurance can apply for the company’s Insulin Value Program, which also entitles them to a cap of $35 per month for the company’s insulin products. (Knapp, 3/1)
NBC News:
Drugmaker Eli Lilly Caps The Cost Of Insulin At $35 A Month, Bringing Relief For Millions
The move, experts say, could prompt other insulin makers in the U.S. to follow suit. The change, which Eli Lilly said takes effect immediately, puts the drugmaker in line with a provision in the Inflation Reduction Act, which last month imposed a $35 monthly cap on the out-of-pocket cost of insulin for seniors enrolled in Medicare. Insulin makers continue to face pressure from members of Congress and advocacy groups to lower the cost of the lifesaving medication. Insulin costs in the U.S. are notoriously high compared to the costs in other countries; the RAND Corporation, a public policy think tank, estimated that in 2018, the average list price for one vial of insulin in the U.S. was $98.70. (Lovelace Jr., 3/1)
CBS News:
Eli Lilly To Cut Insulin Prices, Cap Out-Of-Pocket Costs At $35
About 3 in 10 diabetics in the U.S. rely on insulin from Eli Lilly, one of three drug companies, along with Novo Nordisk and Sanofi, that control the market for the drug. Since introducing their analog insulin products more than two decades ago, the three drugmakers have sharply raised prices for the medications, which control blood sugar more effectively than so-called human insulin. Eli Lilly on Wednesday said it will cut the list price of its Humalog 100 units/mL1, its most commonly prescribed insulin, by 70%. The price cut will take effect during the fourth quarter of 2023, the company said in a statement. The company said that the list price of Humalog U-100 10 mL vials will drop from $274.70 to $66.40. (Picchi, 3/1)
AP:
Lilly Plans To Slash Some Insulin Prices, Expand Cost Cap
Lilly CEO David Ricks said in a statement that it will take time for insurers and the pharmacy system to implement its price cuts, so the drugmaker will immediately cap monthly out-of-pocket costs at $35 for people who are not covered by Medicare’s prescription drug program. That cap applies to people with commercial coverage. Lilly said people without insurance can find savings cards to receive insulin for the same amount at its InsulinAffordability.com website. (Murphy, 3/1)
Pfizer's RSV Vaccine Becomes First To Gain FDA Panel's Recommendation
News outlets report on the vote by an FDA panel, which assessed Pfizer's data on the safety and effectiveness of Pfizer's vaccine for respiratory syncytial virus. The panel concluded it was safe for adults 60 and over. The FDA is set to make a formal decision on the drug soon.
AP:
FDA Panel Narrowly Backs Pfizer RSV Vaccine For Older Adults
Federal health advisers on Tuesday narrowly backed an experimental vaccine from Pfizer that could soon become the first shot to protect older adults against the respiratory illness known as RSV. The Food and Drug Administration panel voted 7-4 on two separate questions of whether Pfizer’s data showed the vaccine was safe and effective against the respiratory virus for people 60 and older. One panelist abstained from voting. The recommendation is non-binding and the FDA will make its own decision on the vaccine in the coming months. (Perrone, 2/28)
Bloomberg:
Pfizer’s RSV Vaccine Wins US Panel’s Backing For Safety In Older People
As it did with its messenger RNA Covid-19 vaccine, Pfizer gained the coveted spot of being first to pass a key barrier to the US market for a lung illness that affects thousand of people each year. Pfizer has been vying with the UK’s GSK Plc over what is estimated to become a $10 billion RSV market. GSK will face its own advisory committee hearing on Wednesday for what infectious disease specialists call the last big respiratory virus without a vaccine. (Cattan, 2/28)
USA Today:
FDA Experts Recommends RSV Vaccine For Adults 60 And Over. What's Next?
The vaccine still needs final say from the FDA commissioner and recommendations by an advisory panel at the Centers for Disease Control and Prevention, which will require another sign-off from the CDC director. If that happens, the vaccine will likely become available by the next RSV season. Then on Wednesday, the FDA’s Vaccines and Related Biological Products Advisory Committee will consider a second RSV vaccine for older adults by GlaxoSmithKline, which would follow the same CDC process if recommended. (Rodriguez, 2/28)
Reuters:
Pfizer Gets FDA Panel's Backing In RSV Vaccine Race
GSK, which is another forerunner in a crowded race to develop the first RSV vaccine, will face scrutiny from a panel of experts to the FDA on Wednesday. Companies such as Johnson & Johnson, Moderna Inc and Merck are also looming on the horizon. (Mandowara and Esunny, 2/28)
Millions Face 'Hunger Cliff' As Pandemic Food Stamp Program Expires
It's estimated that tens of millions of low-income Americans on SNAP will lose about $95 a month for groceries, at a time when food prices are already high. States, food banks, and assistance groups have been scrambling to prepare for the onslaught of people who could struggle with hunger, especially kids, older Americans, and those with chronic illnesses.
ABC News:
Pandemic-Era Food Stamps Ending For Nearly 30 Million Americans
After nearly three years, the federal government is ending pandemic-era payments on March 1 for low-income families on the Supplemental Nutrition Assistance Program, or SNAP. ... The average household will lose $95 a month for groceries, according to a study from the Center on Budget and Policy Priorities. Depending on other factors, including family size and income, some recipients will lose hundreds of dollars a month in food assistance. (Christoforous, 2/28)
The New York Times:
Low-Income Families Brace For End Of Extra Food Stamp Benefits
Tens of millions of low-income families are set to lose additional food stamp benefits on Wednesday after the expiration of a pandemic-era policy that had increased the amount they received, leaving food banks bracing for a surge in demand and some advocates predicting a rise in hunger nationwide. For nearly three years of the pandemic, emergency legislation enacted by Congress sought to cushion the economic blow of the coronavirus, allowing all participants in the Supplemental Nutrition Assistance Program to receive the maximum monthly benefit, regardless of income. The extra cash, along with other economic assistance programs, helped keep food insecurity at bay and cut poverty rates to a record low. (Qiu, 2/28)
Stateline:
States Strive To Help SNAP Recipients Cope With Lower Benefits
States, community groups and food banks are scrambling to help families cope and gear up for an expected wave of food hardship. “People are scared. They’re anxious. This is a devastating change,” Karla Maraccini, director of the Food and Energy Assistance Division of the Colorado Department of Human Services, told Stateline. “We want to make sure nobody is caught off guard in March.” (Mercer, 2/28)
The Hill:
SNAP Cuts Could Lead To ‘Hunger Cliff,’ Experts Fear
Navigating a post-COVID America on pre-COVID-level SNAP benefits might be more of a struggle for others, like the elderly and the chronically ill. Especially now that inflation has caused food prices to balloon by nearly 10 percent since last year, according to the Department of Agriculture. Anti-hunger advocates fear the newly reduced SNAP benefits will drive millions of people to a “hunger cliff” and deeper into poverty as they search for ways to pay for food. (O'Connell-Domenech, 2/28)
PBS NewsHour:
Food Banks Prepare For Spike As Pandemic SNAP Benefits Come To An End
In the last three years, households eligible for food assistance received at least $95 more per month as part of a pandemic-era increase to combat hunger. But Wednesday, those benefits will expire, meaning a smaller monthly food budget for nearly 30 million Americans. William Brangham visited a food bank in rural Virginia that’s gearing up to meet the increased need this cut will likely trigger. (Brangham, Quran and Hastings, 2/28)
USA Today:
Extra SNAP Benefits Are Ending. Here's What You Can Do To Offset The Loss
Check your eligibility. Surprisingly, about 8 million Americans are eligible for some SNAP benefits but may not even know, said Zareena Meyn, executive director at mRelief, a nonprofit with a free platform where people can enter basic information to see if they qualify for SNAP and if so, sign up. (Lee, 2/28)
In related news —
Iowa Public Radio:
Iowa House And Senate Committees Advance Bills To Change SNAP And Medicaid Eligibility
Republican lawmakers in the Iowa House and Senate advanced bills Tuesday that would change eligibility requirements for low-income Iowans to get food and health care assistance, which meant the proposals survived a key statehouse deadline for most bills to get approved by a committee. Both bills, which were amended Tuesday, would limit households seeking food assistance to a maximum of $15,000 in liquid assets and personal property. The applicant’s home, a first car of any value, and a second car worth up to $10,000 would not be included in that calculation. (Sostaric, 2/28)
FDA Cracking Down On Illegal Import Of Xylazine Amid Spike In Overdoses
The action allows for the detainment of shipments of the veterinary tranquilizer and the ingredients used to make it, CBS News reported. Xylazine, also known as "tranq" or "zombie drug" because it causes “patches of dead and rotting tissue," has exacerbated the nation's opioid crisis and has been found in samples from 32 states, The Washington Post says.
CBS News:
FDA Acts To Restrict Illicit Import Of Xylazine, Animal Tranquilizer Linked To Overdose Deaths
The U.S. Food and Drug Administration announced on Tuesday that it was taking action to restrict unlawful importing of the veterinary drug xylazine, which has been "increasingly found" in the nation's illicit drug supply. (Breen, 2/28)
The Washington Post:
FDA To Restrict Imports Of An Animal Sedative, Xylazine, Tied To Overdoses
The drug, known as “tranq” on the street, has alarmed public health experts, law enforcement officers and lawmakers already struggling to control an opioid crisis that is killing thousands each month. In recent years, the impact of xylazine has been particularly acute in Philadelphia, where the drug has been discovered in an overwhelming number of street opioid samples and as of 2019, in 31 percent of all victims of unintentional fatal overdoses in which fentanyl or heroin were detected. (Ovalle, 2/28)
Vice News:
The Feds Are Cracking Down On Tranq Dope
Xylazine is typically sold as a liquid when used for veterinary purposes. However, as VICE News reported last March, hundreds of online vendors are selling powder forms of xylazine. One China-based seller told VICE News that xylazine had become a “hot” product among Americans in 2021. A report from the Drug Enforcement Administration from October found that a kilogram of xylazine powder can be bought from Chinese suppliers from $6-$20 per kilogram. “At this low price, its use as an adulterant may increase the profit for illicit drug traffickers, as its psychoactive effects allows them to reduce the amount of fentanyl or heroin used in a mixture,” the report said. (Krishnan, 2/28)
More on the scourge of xylazine —
WTOP:
‘Zombie Drug’ Challenging Response To Maryland Opioid Crisis
The opioid epidemic in Maryland has entered a new and uncertain phase. Xylazine — also called “tranq” and “zombie drug” — is showing up more and more in the illicit drug supply across the state. ... The drug’s telltale signs are gruesome wounds near the injection sight. “We’re talking about pretty big wounds here — exposing both bone and actual muscles, tendons — very, very significant deep wounds,” said Dr. Malik Burnett, the director of the Center for Harm Reduction Services at the Maryland Department of Health. “Very much in the framework of amputation level.” (Garrett, 3/1)
KGET:
Newest Killer On The Street: Xylazine, An Animal Tranquilizer That Doesn't Respond To Narcan
There’s a dangerous new drug out there that’s been devastating U.S. cities for the past year and it does not respond to the lifesaving anti-opioid drug Narcan. ... The lack of awareness and testing for Xylazine could mean its real impact has been underreported. Many county coroner’s offices do not test for it. (Price, 2/28)
In other news about the opioid crisis —
AP:
West Virginia Senate Enhances Drug Penalties To Felony
West Virginia’s Senate passed a bill Tuesday that would make it a felony to possess fentanyl and some other illegal drugs in the opioid-ravaged state. The bill passed on a 32-1 vote and now goes before the House of Delegates. The regular session ends March 11. (Raby, 2/28)
CBS News:
Fentanyl In Alaska: How The Synthetic Opioid Is Affecting The State
An influx of fentanyl into Alaska in the last two years has vexed law enforcement, overwhelmed health systems and deeply affected struggling Native communities. In 2020 and 2021, the synthetic opioid was a major contributor in a spike in overdoses – the nation's largest, according to Alaska's public health department. In 2021, overdose deaths jumped by 74% in one year, with fentanyl deaths spiking by 150%, the report said. (Tabachnick, 3/1)
Biden Says 'Health Care Hangs In The Balance' Of GOP's Budget Cut Plans
In a speech Tuesday, President Joe Biden pressured Republicans to release their plans to cut government spending, which are expected to target Medicaid and the Affordable Care Act. And in another preview of the 2024 presidential race, Donald Trump is warning his party against touching Medicare.
AP:
Biden Warns Of 'MAGA' Republicans' Desire To Cut Spending
President Joe Biden on Tuesday said GOP lawmakers could put millions of people’s health care at risk, honing his message ahead of the release of his budget plan next week as Republicans push for him to negotiate over spending levels. The Democratic president spoke at a recreation center in Virginia Beach, Virginia. His remarks were part of a broader effort this week to contrast his administration’s priorities with those of Republicans who have yet to spell out their budget cuts. Using past proposals, Biden said the GOP could try to slash Medicaid and Obamacare benefits, as well as Social Security and Medicare. “What are they going to cut? That’s the big question,” Biden said Tuesday. “For millions of Americans, health care hangs in the balance.” (Long and Boak, 3/1)
KHN:
Biden Promises To Fight GOP On ‘Gutting’ Medicaid. Budget Talks Seem Like Another Story.
Most lawmakers — Republicans and Democrats alike — have declared the marquee safety-net programs of Medicare and Social Security off-limits for cuts as a divided Washington heads for a showdown over the national debt and government spending. Health programs for lower-income Americans, though, have gotten no such bipartisan assurances. More than 20 million people gained Medicaid coverage in the past three years after Congress expanded access to the entitlement program during the covid-19 pandemic, swelling Medicaid’s population by about 30%. But enrollment will fall starting in April, when the pandemic-era changes end and states begin cutting coverage for Americans who are no longer eligible. (McAuliff, 3/1)
Politico:
Trump Ties GOP In Knots Over Medicare And Social Security
Donald Trump is driving a wedge through the GOP over one of American politics’ thorniest issues: the future of Medicare and Social Security. The former president’s attacks on potential GOP primary opponents, and his warning to party leaders to stay away from the popular entitlement programs in their push to cut spending, are cleaving Republicans at every level. (Everett and Emma, 3/1)
On Medicare Advantage —
Salon:
"Bailed Out By Taxpayers": Data Shows Big Insurance Profiting Massively From Medicare Privatization
Anew analysis released Monday shows that insurance giants are benefiting hugely from the accelerating privatization of Medicare and Medicaid, which for-profit companies have infiltrated via government programs such as Medicare Advantage. According to the report from Wendell Potter, a former insurance executive who now advocates for systemic healthcare reform, government programs are now the source of roughly 90% of the health plan revenues of Humana, Centene, and Molina. (Johnson, 2/28)
Healthcare Finance News:
Medicare Advantage Sees Fewer Avoidable Hospitalizations Than Original Medicare
Medicare Advantage had fewer avoidable hospitalizations for ambulatory care−sensitive conditions (ACSCs) when compared to traditional Medicare, but were more likely to have observation stays and emergency department direct discharges for the same conditions, according to findings published in the Journal of the American Medical Association. These findings raise the possibility of a "shifting effect," authors said, whereby Medicare Advantage patients are more likely than traditional Medicare patients to be treated under observation status or in the ED instead of being admitted to the hospital. (Lagasse, 2/28)
Modern Healthcare:
Clover Health Reduces Medicare Advantage Marketing To Cut Costs
The insurer's net loss was down to $338.8 million in 2022 after it reduced spending by its in-house broker, Seek Medicare, the company announced during a call with investors. Revenue grew 136.1% to $3.4 billion driven by higher Medicare Advantage and Accountable Care Organization enrollment.. Clover Health had almost 89,000 Medicare Advantage members and 164,000 ACO REACH participants last year. (Tepper, 2/28)
Forbes:
Alignment Healthcare Eclipses 100,000 Medicare Advantage Members As Losses Narrow
Alignment Healthcare Tuesday reported a loss in its fourth quarter of nearly $57 million as the startup provider of Medicare Advantage coverage launches into new markets and projects health plan membership of more than 100,000 in the new year. (Japsen, 2/28)
In other news about Medicare —
Axios:
New Alzheimer's Drug Renews Push For Medicare Coverage
The Biden administration's decision last week to continue restricting Medicare coverage for a class of Alzheimer's drugs has angered some Republicans and renewed a thorny debate over when seniors should have access to new treatments — and under what conditions. (Owens, 2/28)
Modern Healthcare:
Walmart, CareSource Health Disparities Program Planned
Walmart and the health insurer CareSource have forged a partnership to conduct risk screenings and provide wellness services to customers at select retail locations in Ohio, the companies announced Tuesday. The three-year arrangement will focus on improving outcomes among CareSource's Medicare, Medicaid and health insurance exchange policyholders who have conditions such as heart disease, diabetes and hypertension. (Hartnett, 2/28)
The CT Mirror:
CT Proposes Reducing Funding For Nursing Homes With Empty Beds
A new bill proposed by the state Department of Social Services would financially penalize nursing homes that don’t have more than 90% of their beds filled over a 12-month period. About 60% of the state’s nursing homes have occupancy levels below 90% as of Feb. 12, according to data from the Center for Medicare and Medicaid Services. (Altimari and Martinez, 2/28)
Missouri, Mississippi Advance Bills To Expand Postpartum Medicaid Benefits
House committees in both states moved bills forward that would provide additional Medicaid coverage to qualifying people for 12 months after giving birth. The Hill reports on efforts in 28 states to offer additional postpartum benefits.
AP:
Mississippi House Panel OKs Longer Medicaid After Births
A Mississippi House committee advanced a bill Tuesday that would provide women with a full year of Medicaid coverage after giving birth, just days after Republican Gov. Tate Reeves voiced his support for the measure. The bill passed the House Medicaid Committee on a voice vote, with some opposition. (Pettus, 2/28)
St. Louis Post-Dispatch:
Missouri House Panel Advances ‘Clean’ Maternal Mortality Measure
A House panel Tuesday moved to expand Medicaid coverage for low-income mothers and their babies without Senate language that could otherwise endanger federal approval of the long-sought extension. A week after the Senate approved a plan to offer health insurance coverage to moms and babies for 12 months after a pregnancy, the House Emerging Issues Committee voted unanimously to forward their version of the bill to the full House. The key difference in the two is the lack of provisions that would bar women who have abortions from receiving the extended benefits. (Erickson, 2/28)
The Hill:
These States Have Extended Medicaid Coverage For New Mothers
There have been 28 states that have adopted and implemented the Medicaid postpartum coverage extension thus far, which is available to states for five years. The list includes Republican states that did not even adopt the Medicaid expansion offered in the Affordable Care Act, such as Florida, Alabama, Georgia, Kansas, South Carolina and Tennessee. (Neukam, 2/28)
More Medicaid developments —
Chicago Tribune:
As Many As 700,000 Illinois Residents Could Lose Medicaid Health Coverage This Year
Jose Salmeron doesn’t want to think about what would happen if he lost his Medicaid coverage. The 70-year-old Cicero resident has been on the state and federally funded health insurance program, which is for people with low incomes and disabilities, for years. It covered him when he had heart surgery in 2015 and helps to pay for his ongoing care. “I would not have access to medical services,” Salmeron said in Spanish, of if he lost Medicaid coverage. He’s also on Medicare because of his age, but Medicaid helps cover many costs that might otherwise be out-of-pocket and unaffordable for him. “What would I do?” (Schencker, 2/28)
12news.com:
Many Arizonans Could Soon Lose Medicaid Coverage
Arizona will soon determine who among the 2.5 million residents enrolled in the state's Medicaid programs are still eligible for the low-cost health coverage. Starting April 1, the Arizona Health Care Cost Containment System will begin disenrolling Medicaid members who are no longer eligible for the program. (Reagan and Dana, 2/27)
CBS Pittsburgh:
3 Million Pennsylvanians Need To Renew Medicaid Eligibility To Continue State-Sponsored Health Insurance
Three million Pennsylvanians on Medicaid during the pandemic will have to reapply for continued coverage beginning April 1. (Delano, 2/28)
KHN:
Idaho Dropped Thousands From Medicaid In The Pandemic’s First Years
During the first two years of the covid-19 pandemic, while the federal government was trying to prevent people on Medicaid from losing health coverage, Idaho dropped nearly 10,000 people from the safety-net program. Federal law generally banned states from dropping people, and federal officials said Idaho acted improperly. Idaho officials, however, said they didn’t think they did anything wrong. (Pradhan, 3/1)
States May See Your Reproductive Data Through FBI Sharing Hubs, Dems Warn
Axios reports that Sens. Ron Wyden (D-Ore.) and Mazie Hirono (D-Hawaii) and Rep. Sara Jacobs (D-Calif.) expressed concern in a letter Monday evening that FBI and Department of Homeland Security resources could be used to help undermine access to reproductive care.
Axios:
Lawmakers Warn Biden On Feds Aiding Anti-Abortion Investigations
Democrats in Congress are warning the Biden administration that federal agencies could be indirectly aiding state and local law enforcement investigations that could result in the prosecution of abortion providers and patients. (Gonzalez, 2/28)
Axios:
Post-Roe, Prosecutors Can Seek Unprotected Reproductive Health Data
The increasing criminalization of abortion in the U.S. is exposing major gaps in the legal protection of health information, as more health data ends up in the hands of patients rather than doctors. (Gold and Gonzalez, 3/1)
More on abortion from Mississippi, Iowa, Texas, and Minnesota —
AP:
Mississippi Could Renew Initiatives But Ban Them On Abortion
Mississippi residents might get back the ability to enact public policy through statewide ballot initiatives, but people would be banned from using the process to change abortion laws. Republican lawmakers advanced a proposal Tuesday that would strip voters of their ability to launch abortion measures under a revived ballot initiative process. (Goldberg, 3/1)
Des Moines Register:
Why An Iowa Abortion Ban Likely Won't Pass The Legislature This Year
Twenty House Republicans have introduced a bill that would state that life begins at conception and ban all abortions in Iowa. But legislative leaders say they don't expect to advance the measure this year as they wait on the outcome of a state Supreme Court case. (Gruber-Miller, 2/28)
The Texas Tribune:
Wendy Davis To Lead Planned Parenthood’s Political Advocacy Arm
Ten years after her historic filibuster, former state Sen. Wendy Davis will be returning to the Texas Capitol in a new role: senior adviser to Planned Parenthood Texas Votes. She joins the group’s political fundraising and advocacy arm at a low point for reproductive rights in Texas. Abortion access has been obliterated in Texas and many of the surrounding states. Abortion funds have stopped financially supporting people who travel out of state to have the procedure, fearing prosecution. After moving Planned Parenthood out of the Medicaid program, Texas is now trying to sue the clinics out of existence. (Klibanoff, 2/28)
NPR:
3 Abortion Bans In Texas Leave Doctors 'Talking In Code' To Pregnant Patients
The first amendment of the constitution protects free speech, explains Elizabeth Sepper, professor of law at University of Texas at Austin. "Physicians have independent speech rights, to speak to their patients openly," she says. "Physicians should not be scared to say the 'a-word.'" Nevertheless, that seems to be what's happening. Many doctors in Texas who treat pregnant patients are extremely scared, especially of language in one of the state's abortion bans that allows people to take civil action against anyone who "aids or abets" abortion. (Simmons-Duffin, 3/1)
Minnesota Public Radio:
The Reality Of Later-In-Pregnancy Abortion Is More Complex Than MN Debate Lets On
When a patient goes to see Dr. Rachel Pilliod, the situation is often a complicated one. As a maternal fetal medicine specialist, Pilliod often sees pregnant patients referred to her after they get an anatomy scan from their primary physician, at around 20 weeks gestation. If something looks off with how the baby is developing, Pilliod and her colleagues take a closer look. They do follow-up imaging and tests to determine the scope of the situation, through MRIs and genetic testing. (Wiley and Ferguson, 2/28)
Covid Vaccine Maker Novavax Warns It May Go Out Of Business
The covid vaccine maker "raised doubts" about its business future, Reuters reports, even as it works toward a fall vaccination campaign. Meanwhile, news outlets report on the increasing spread of omicron covid, how structural brain changes link to long covid symptoms like fatigue, and more.
Reuters:
Novavax Raises Doubts About Ability To Remain In Business, Shares Fall
COVID-19 vaccine maker Novavax Inc on Tuesday raised doubts about its ability to remain in business and announced plans to slash spending as it works to prepare for a fall vaccination campaign, and its shares plunged more than 25%. The company said there is significant uncertainty around its 2023 revenue, funding from the U.S. government, and pending arbitration with global vaccine alliance Gavi. But its cash flow forecast indicates it has sufficient capital to fund operations over the next year. (Erman, 2/28)
In other covid vaccine news —
AP:
Troops Who Refused COVID Vaccine Still May Face Discipline
The military services are still reviewing possible discipline of troops who refused the order to get the COVID-19 vaccine, defense officials told Congress on Tuesday, and they provided few details on how many of those who were forced out of the military would like to return. Lawmakers expressed frustration with the news, questioning why service members should still face discipline since the vaccine requirement had been rescinded. (Baldor, 2/28)
Billings Gazette:
Bill To Prevent MRNA Vaccine Recipients From Donating Blood Is Killed
The House Human Services committee has killed a bill that would have made it illegal to donate blood or tissue if the donor had received any mRNA vaccines or treatments. The bill called for perpetrators who knowingly collect and distribute blood or tissue “containing gene-altering proteins” or other “isolates introduced by mRNA or DNA vaccines” or chemotherapies, to face a misdemeanor charge punishable by a fine up to $500. (Schabacker, 2/28)
More on the spread of covid —
CIDRAP:
81% Of Toilet Samples From US-Bound Planes Had Omicron RNA
Two new studies from Morbidity and Mortality Weekly Report highlight new findings about air travel amid COVID-19, with one showing that 81% of wastewater samples from airplane restrooms had SARS-CoV-2 Omicron variant genetic material in fall 2022, and the other suggesting that predeparture testing of international travelers was tied to a 52% lower positivity rate at arrival in the United States. (Van Beusekom, 2/28)
Stat:
Covid Monitoring Gave Essential Workers Little Data To Protect Health
At the peak of the pandemic, essential workers faced rampant tech-based surveillance, from overhead infrared thermometers to wearables that tracked their proximity to one another. These technologies forced employees to adjust the way they worked and sometimes made their workplaces less safe. They also didn’t offer workers clear and accurate information that would help them protect their health, according to a new report by the nonprofit Data & Society. (Castillo, 3/1)
The Atlantic:
The Rules Of Asymptomatic COVID Have Changed
In the early days of the pandemic, one of the scariest and most surprising features of SARS-CoV-2 was its stealth. Initially assumed to transmit only from people who were actively sick—as its predecessor SARS-CoV did—the new coronavirus turned out to be a silent spreader, also spewing from the airways of people who were feeling just fine. After months of insisting that only the symptomatic had to mask, test, and isolate, officials scrambled to retool their guidance; singing, talking, laughing, even breathing in tight quarters were abruptly categorized as threats. (Wu, 2/28)
Los Angeles Times:
L.A. County Will End Its COVID-19 Emergency March 31
Los Angeles County will end its COVID-19 emergency declaration at the end of March, becoming the latest region to take that step amid improving pandemic conditions. The move, approved unanimously Tuesday by the county Board of Supervisors, came the same day Gov. Gavin Newsom formally rescinded the statewide emergency declaration issued three years ago during the onset of the coronavirus outbreak. (Money and Lin II, 2/28)
On long covid —
CIDRAP:
COVID-Related Brain Changes May Lead To Long-Term Fatigue
Structural changes in the brain may explain the persistent fatigue and neuropsychiatric complications associated with long COVID, finds an observational study published yesterday in eClinicalMedicine. (Van Beusekom, 2/28)
Coronavirus 'Lab Leak' Theory Supported By FBI Director
FBI Director Christopher Wray said the source of covid was likely a laboratory leak in China, The Wall Street Journal reports. China's government maintains it has been "open and transparent" on its own efforts to trace covid's origin. Other news includes efforts to prevent the next pandemic.
The Wall Street Journal:
FBI Director Says Covid Pandemic Likely Caused By Chinese Lab Leak
FBI Director Christopher Wray said Tuesday that the Covid pandemic was probably the result of a laboratory leak in China, providing the first public confirmation of the bureau’s classified judgment of how the virus that led to the deaths of nearly seven million people worldwide first emerged. “The FBI has for quite some time now assessed that the origins of the pandemic are most likely a potential lab incident in Wuhan,” Mr. Wray told Fox News. “Here you are talking about a potential leak from a Chinese government-controlled lab.” (Gordon and Strobel, 2/28)
Axios:
China Insists It Has Been "Open And Transparent" On COVID Origins
China's Foreign Ministry claimed on Tuesday that the country has been "open and transparent” about its efforts to trace the origins of COVID-19 and accused the U.S. of politicizing the issue. News reports emerged over the weekend that U.S. Department of Energy concluded in a "low confidence" assessment that the pandemic most likely started from a laboratory leak. (Saric, 2/28)
Politico:
GOP Divided On How To Respond To ‘Lab Leak’ Report
Congressional Republicans are anxious to use new Covid-19 lab leak reports to lash out at the ruling Chinese Communist Party and paint President Joe Biden’s administration as soft on Beijing. But they have reached little consensus on how exactly to do that. (Ollstein and Bade, 2/28)
On preventing another pandemic —
The Hill:
Birx: US Not Doing Enough To Prevent Another Pandemic Like COVID
Deborah Birx, a physician who served as former President Trump’s coronavirus response coordinator, said on Tuesday that the U.S. isn’t doing enough to prevent another pandemic like COVID-19.“To me, what’s really important as we went through this after SARS, and the World Health Organization’s developed treaties, we spent literally hundreds of millions of dollars on saying we were ready and we would prevent the next pandemic and it happened,” Birx said on “CNN This Morning.” “So let’s be very clear that what we have done today has failed. And I worry that we haven’t put the new things in place that will keep us and protect us from the next pandemic,” she added. (Mueller, 2/28)
Axios:
Biotech Startup Focused On Bat Biology Raises $100 Million
Paratus Sciences, a Massachusetts drug discovery startup leveraging bat biology, has raised $100 million in venture capital funding. This has been a winning week for bats, long maligned for spreading disease and general creepiness. First, there was the (still unreleased) Department of Energy report that COVID-19 was more likely to have been caused by a lab leak than by zoonotic spillover. And now this big-money effort to study the flying mammals for the purpose of developing human therapeutics in areas like inflammation. (Primack, 2/28)
Also —
CIDRAP:
US Reports New H5N1 Avian Flu Detections In Mammals
The US Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) added 10 more H5N1 avian flu detections in mammals to its running list, which adds reports from four states and includes five different species. Seven of the detections were in Colorado, where the virus was found in three mountain lions, a bobcat, two red fox, and a black bear. Kansas and Oregon both reported detections in striped skunks, and North Carolina reported a detection in a black bear. (Schnirring, 2/28)
FBI Finds That Ransomware Hackers Hit Health Sector Most In 2022
Bank Info Security reports "the brunt" of ransomware attacks on critical infrastructure sectors in 2022 was borne by health care and public health entities — schools came second. Also in the news, a fall in Mayo Clinic's profits, a tumble in GoodRx's revenues, an affordable housing project by CVS and more.
Bank Info Security:
Healthcare Most Hit By Ransomware Last Year, FBI Finds
Healthcare and public health bore the brunt of ransomware attacks on critical infrastructure sectors launched during the last year, says the FBI. The FBI's Internet Complaint Center last year received 870 complaints that "indicated organizations belonging to a critical infrastructure sector were victims of a ransomware attack," said David Scott, deputy assistant director of the FBI's Cyber Division, speaking at the Futurescot conference Monday in Glasgow, Scotland. Critical manufacturing and the government, including schools, followed healthcare as the most-attacked sectors, IC3 data shows. (Schwartz, 2/27)
In other health care industry updates —
Modern Healthcare:
Mayo Clinic’s 2022 Profits Plummet By More Than 50%
Rising wage and supply costs, in addition to poor performance in the financial markets, sent Mayo Clinic's profit plummeting by more than half in 2022. The Rochester, Minnesota-based nonprofit reported $2.2 billion in net income for 2022, a 58.4% drop from $5.3 billion in 2021. Operating income dropped 50.9% to $595 million, the system said Monday. (Hudson, 2/28)
Modern Healthcare:
GoodRx Revenue Fell In 2022's 4th Quarter
GoodRx’s fourth-quarter earnings reflected the consumer digital health company’s financial challenges. Quarterly revenue decreased 14% to $184 million, and the company said its issue with Kroger, a national grocery chain, cost it $40 to $50 million in lost revenue. Kroger temporarily stopped accepting GoodRx’s discounts at the point of sale in May. The matter was resolved in August but GoodRx said at the time the financial effect of the dispute was going to linger for the remainder of the year. (Perna, 2/28)
Modern Healthcare:
Privia Health Becomes Profitable In 2022's 4th Quarter
Privia Health turned a profit in 2022's final quarter. The Arlington, Virginia-based physician enablement company on Tuesday reported fourth-quarter net income of $17.8 million, or 14 cents per share, compared with a net loss of $12 million, or 11 cents per share, in the year-ago period. Fourth-quarter revenue increased 32.4%, to $364.4 million. (Turner, 2/28)
Indianapolis Star:
CVS Health Spends $10 Million In Affordable Housing Project
In an effort to address homelessness, CVS Health announced Tuesday that it is spending $10 million to build a 48-unit affordable supportive housing apartment community on the west side. "At CVS, we know the first step to improving health and wellbeing is access to safe, clean, affordable housing," Lena Barkley of CVS Health Workforce Initiatives said at the announcement. (Lyn Cheang, 2/28)
Crain's Chicago Business:
Outcome Health Fraud Trial: Rishi Shah Attorney Grills Ashik Desai
Rishi Shah’s defense attorney is painting the government’s star witness, Ashik Desai, as someone whose inexperience and ambition led him to commit fraud and sell out his former Outcome Health bosses to save his own skin. (Pletz, 2/28)
Also —
WUFT:
A Specialized Ambulance For Stroke Patients Is On The Way At UF Health
Every 40 seconds, someone has a stroke in the U.S. Every three and a half minutes, someone dies from a stroke. Strokes are leading causes of long-term disability. These statistics from the Centers for Disease Control and Prevention are exactly why officials at UF Health Shands Hospital are forming specialized stroke ambulances. (Barrera and Weinstein, 2/28)
The Wall Street Journal:
How Doctors Use AI To Help Diagnose Patients
Artificial intelligence is slowly changing the care that you get at the doctor’s office and in hospitals. At Mayo Clinic’s cardiology department, doctors use an artificial-intelligence program to help detect new heart problems. Elsewhere, a group of primary-care doctors is using it to help identify an eye condition that can lead to blindness. A number of hospitals are using it to catch patients at risk for sepsis. (Reddy, 2/28)
USA Today:
Community Health Centers Can Fill America's Primary Care Gap: Report
Nearly a third of Americans lack access to primary care, according to a new report. More than 100 million people in the United States don't have a primary care provider, and about a quarter of those are children, according to the report, "Closing the Primary Care Gap," released Monday by the National Association of Community Health Centers. (Hassanein, 2/28)
KHN and CBS News:
This Dental Device Was Sold To Fix Patients’ Jaws. Lawsuits Claim It Wrecked Their Teeth.
Boja Kragulj, an accomplished clarinetist who once performed with orchestras in New York, Philadelphia, and Jacksonville, Florida, has already lost four teeth. And she expects to lose at least a dozen more. Five years ago, seeking to correct her bite and improve her breathing, Kragulj tried a dental device that she was told would put pressure on her upper palate, lengthening her jawbone to fix her issues without surgery, according to an ongoing lawsuit she has filed in federal court. Kragulj said she discovered the device through Facebook, and it sounded “miraculous.” (Kelman and Werner, 3/1)
Mississippi, Oklahoma Move Against Transgender Care For Minors
Mississippi banned gender-affirming care for transgender youth, the third state to do so this year. Meanwhile, a Republican-led House bill was approved Tuesday that would ban insurance coverage for young people's gender care.
Axios:
Mississippi Bans Gender-Affirming Care For Trans Youth
Mississippi became the third state to ban gender-affirming care for transgender youth in 2023 after Gov. Tate Reeves (R) signed the GOP-led bill into law on Tuesday. The move comes amid a mounting attack on trans rights that has escalated in recent weeks as high-profile Republicans, including former President Trump, are jockeying to establish increasingly extreme positions on gender-affirming care. (Chen, 2/28)
Oklahoman:
Oklahoma House Votes To Ban Insurance For Transgender Care
House Republicans approved a bill Tuesday banning insurance coverage for transgender health care, one of many proposals this year seeking to limit gender transition procedures. House Bill 2177 now moves to the state Senate after the House passed the measure with an 80-18 vote. All 18 votes against were by Democratic members. (Felder, 2/28)
In other health news from across the U.S. —
The Colorado Sun:
Colorado Lawmakers Target Hospital Facility Fees
Last year, Diane Kruse and her husband, Kevin, went to visit the doctor. Kevin needed to get some things checked out with his heart, nothing urgent or out of the ordinary. After looking through their insurance network, they settled on a cardiologist working at a satellite clinic on the National Jewish Health campus in Denver. The visit felt routine — the only piece of equipment the doctor needed to use was a stethoscope. But it was the bills that came as a surprise. (Ingold, 3/1)
AP:
North Carolina Senate Backs Legalizing Pot For Medical Use
The North Carolina Senate voted on Tuesday to legalize marijuana use for medical purposes, giving strong bipartisan support for the second year in a row to an idea that its supporters say would give relief to those with debilitating or life-ending illnesses. ... The proposal is almost identical to a bill the Senate passed last June by a similar margin, which then stalled in the House. (Robertson, 2/28)
North Carolina Health News:
Firearm-Related Deaths Rise For NC Teens, Child Death Data Shows
In North Carolina, 1,360 children died from illness, accidents, homicide or suicide in 2021.That equates to about 76 classrooms of children, said epidemiologist Kathleen Jones-Vessey with the N.C. Division of Public Health during a briefing Monday afternoon on the new data. The overall death rate of children ages birth to age 17 — 59.1 per 100,000 resident children — reached its highest level since 2016, according to a separate report to the governor and the General Assembly from the Child Fatality Task Force. (Fernandez, 3/1)
Iowa Public Radio:
Annual Cancer Report Finds Increase In Iowa Cancer Cases, But Fewer Deaths
The latest annual report from the Iowa Cancer Registry found Iowa has the second highest incidence rate of cancer cases in the country. According to the 2023 Cancer in Iowa report, Iowa is second only to Kentucky when it comes to incidence rates of cancer and was the only state with a significant increase in cancer cases from 2015 to 2019, the most recent state-level data available. (Krebs, 2/28)
The Washington Post:
Woman Dies After Begging Knoxville Police For Medical Help, Video Shows
Over the course of at least seven minutes, Lisa Edwards repeatedly asked the Knoxville, Tenn., police officers surrounding her for her inhaler. The 60-year-old was arrested the morning of Feb. 5 on trespassing charges after she refused to leave the Fort Sanders Regional Medical Center that Sunday when she was discharged. While officers were trying to take her into custody, she told them, “I can’t breathe,” according to body-camera footage. As Edwards continued her pleas for help that morning, one officer called them “an act.” (Somasundaram, 2/28)
In environmental health news from Louisiana and Texas —
The Guardian:
US Justice Department Sues Two Companies Over Pollution In Louisiana’s ‘Cancer Alley’
The US justice department has sued the two petrochemical giants behind a facility in Louisiana’s “Cancer Alley” responsible for the highest cancer risk rates caused by air pollution in the US in a major federal lawsuit that seeks to substantially curb the plant’s emissions. Unveiled on Tuesday, the lawsuit alleges emissions at the Pontchartrain Works facility in Reserve, Louisiana, violate the Clean Air Act and “present an imminent and substantial endangerment to public health and welfare”. (Laughland, 2/28)
Houston Chronicle:
Union Pacific, EPA Reach Agreement For Tests At Houston Wood Site
The U.S. Environmental Protection Agency and Union Pacific announced a pact Monday to conduct environmental tests at an old rail yard in Houston's Fifth Ward, a decision that comes after city tests revealed cancer-causing dioxins in dozens of samples from nearby neighborhoods. (Wayne Ferguson, 2/27)
Want To Lower Your Disease Risks? Try 11 Minutes Of Daily Aerobics: Study
A large, new study has found that just 11 minutes of aerobic exercise daily, at moderate to vigorous energy levels, can lower cancer, cardiovascular disease, and premature death risks. The Washington Post says merely walking for 11 minutes can do the job, lowering premature death risk by 25%.
CNN:
11 Minutes Of Aerobics Daily Lowers Disease Risk, Study Says
When you can’t fit your entire workout into a busy day, do you think there’s no point in doing anything at all? You should rethink that mindset. Just 11 minutes of moderate-to-vigorous intensity aerobic activity per day could lower your risk of cancer, cardiovascular disease or premature death, a large new study has found. Aerobic activities include walking, dancing, running, jogging, cycling and swimming. You can gauge the intensity level of an activity by your heart rate and how hard you’re breathing as you move. (Rogers, 2/28)
The Washington Post:
Walking 11 Minutes A Day Lowers Early Death And Health Risks, Study Shows
Its findings show that even small amounts of exercise contribute to substantial improvements in longevity and can lower risks of developing or dying of heart disease and many types of cancer. “The investigators looked extensively at the available evidence and provided encouraging findings,” said I-Min Lee, a professor of epidemiology at Harvard T.H. Chan School of Public Health who was not involved in the new study. (Reynolds, 2/28)
More on heart health —
The Boston Globe:
Women Are Much More Likely To Say No To Cholesterol-Lowering Drugs, Boston Researchers Find
Heart disease is the number one killer in the United States, hands down, and cholesterol-lowering drugs, known as statins, have long proven successful in helping reduce the risk for heart attacks and strokes. But a new study from Boston researchers finds that among patients at the highest risk of developing cardiovascular disease, more than one in five refused to take statin medication. (Lazar, 2/28)
Fox News:
Bisexual Women May Face A Higher Heart Disease Risk, New Research Suggests
Most people may not consider sexual orientation a risk factor for heart disease — but a recent study suggests that bisexual women may have poorer cardiovascular health (CVH) than heterosexual females. Researchers analyzed data from 12,180 people with an average age of 39. About half of those people were female. (Rudy, 2/28)
KHN:
Listen To The Latest ‘KHN Health Minute’
On this week’s KHN Health Minute, hear about how Twitter users are shaping insulin policy and how covid vaccines may protect your heart. (2/28)
On brain health —
The Washington Post:
How Does The Brain Age Across The Lifespan? A New Study Offers Clues
An international team of researchers collected brain scan data from multiple studies representing 101,457 brains at all stages of life. The youngest scan in the study came from a 16-week-old fetus; the oldest was from a 100-year-old. Across this large data set, some striking milestones emerged. (Gilbert, 2/28)
The Washington Post:
Even Mild Concussions Can Affect Memory And Cognition Years Later
Experiencing three or more concussions, even mild ones, can lead to cognitive problems decades later, according to research published in the Journal of Neurotrauma. But just one moderate to severe concussion — or traumatic brain injury (TBI), in medical terms — was found to have a long-term impact on brain function, including but not limited to memory issues. (Searing, 2/28)
Scientific American:
Your Brain Could Be Controlling How Sick You Get--And How You Recover
A growing group of scientists are mapping out the brain’s control over the body’s immune responses. There are multiple lines of communication between the nervous and the immune systems — from small local circuits in organs such as the skin, to longer-range routes beginning in the brain — with roles in a wide range of diseases, from autoimmunity to cancer. This field “has really exploded over the last several years”, says Filip Swirski, an immunologist at the Icahn School of Medicine at Mount Sinai in New York City. (Kown, 2/27)
AP:
Former NFL Star, CBS Anchor Irv Cross Had Brain Disease CTE
Irv Cross was a man of faith and devout fan of football who could no longer in his final years attend Bible study or watch NFL games with friends. The degenerative brain disease that festered inside the former Philadelphia Eagles cornerback had triggered depression, mood swings and the type of memory loss that forced him into isolation. ... Cross, the former NFL defensive back who became the first Black man to work full-time as a sports analyst on national television, is the latest football player diagnosed with the brain disease CTE. Cross, who was 81 when he died Feb. 28, 2021, suffered from stage 4 chronic traumatic encephalopathy, Boston University researchers said Tuesday. (Gelston, 2/28)
On sleep —
Boston Herald:
Boston Researchers Sound Alarm On Sleep Health Misinformation In Popular YouTube Videos
A new study from researchers at Brigham and Women’s Hospital has identified an alarming amount of medical misinformation in videos about sleep disorders on YouTube. The researchers found that “popular” videos created by bloggers garnered significantly more views than expert-led videos. Also, the popular videos contained misinformation, while promoting products and services. (Sobey, 2/27)
Fox News:
Irregular Sleep Could Put You In The Danger Zone For Heart Disease: Study
If you go to bed and wake up at different times throughout the week — or if your sleep gets disrupted during the night — you could face a higher risk of heart disease, according to a new study published by the American Heart Association. The study looked at 2,032 older adults, measuring both the duration and timing of their sleep. (Rudy, 2/28)
On mental health —
ABC News:
To Lower Military Suicides, Pentagon Panel Advises Waiting Periods On Guns And More
Among the nearly 130 recommendations in a report last week from the Suicide Prevention and Response Independent Review Committee are: a seven-day waiting period for gun purchases on bases and other Department of Defense property as well as a four-day waiting period for ammunition purchases there, a raise in the minimum age for buying firearms there, from 18 to 25, and the repeal of a 2013 law that bars the military from tracking gun purchases. (McCarthy, 3/1)
NPR:
Study: LGBTQ+ Youth Are Less Likely To Feel Depressed With Parental Support
Young people who identify as LGBTQ+ were less likely to report symptoms of depression when they had general support from their parents, according to a study published Tuesday. Previous research has examined parental support directly tied to a person's LGBTQ+ identity, but the study, which was published by the University of Texas at Austin researchers in the Child Development journal, asked LGBTQ+ youth to answer how often their parents did things like say how proud they were of them or assisted them with activities. (Archie, 3/1)
If you are in need of help —
Dial 9-8-8 for 24/7 support from the Suicide & Crisis Lifeline. It's free and confidential.
Approval Of Drug For Friedreich’s Ataxia Could Open Door For Other Researchers Of Rare Illnesses
Read about the biggest pharmaceutical developments and pricing stories from the past week in KHN's Prescription Drug Watch roundup.
Stat:
FDA Approves Reata's Treatment For Rare Neurological Disease
The Food and Drug Administration on Tuesday approved the first drug to treat Friedreich’s ataxia, a rare, neurological disease. The new drug, called Skyclarys, is made by Reata Pharmaceuticals. (Feuerstein, 2/28)
The Wall Street Journal:
FDA Widens Path For Rare-Disease Treatments With New Approval
The FDA typically requires results from two clinical trials demonstrating a drug’s efficacy to ensure positive results in one trial are replicable. But with rare conditions, finding enough patients to run two clinical trials can be daunting, said Jennifer Farmer, chief executive officer of the Friedreich’s Ataxia Research Alliance, which funds research on the disease, including the natural history study. Families of patients have raised about $1 million a year to fund the study, Ms. Farmer said. (Marcus, 2/28)
In other pharmaceutical developments —
Reuters:
Jazz Pharma Ruling Clears U.S. Roadblock For Rival Narcolepsy Drug
A U.S. appeals court ordered Jazz Pharmaceuticals Inc on Friday to de-list a patent related to its blockbuster narcolepsy drug Xyrem from the U.S. Food and Drug Administration's register of approved medications, in a win for rival drugmaker Avadel CNS Pharmaceuticals Inc. (Brittain, 2/26)
FiercePharma:
Cytokinetics’ Heart Failure Drug Gets A Thumbs Down From FDA
With an innovative approach to treating heart failure, Cytokinetics touted a game-changing medicine that could someday become available for an elusive condition that effects more than 6 million in the U.S. (Dunleavy, 2/28)
FiercePharma:
Novartis Halts Pluvicto New Patient Starts Amid Supply Struggle
For patients with metastatic castration-resistant prostate cancer (mCRPC) who have failed on prior treatments, Novartis’ radiotherapy Pluvicto offers a novel option. But the drug can be hard to come by these days, with supply constraints dogging existing patients and also delaying treatment for potential new takers. (Liu, 2/28)
ScienceDaily:
New Purification Method Could Make Protein Drugs Cheaper
Engineers devised a way to purify protein drugs during manufacturing. Their approach, which uses nanoparticles to rapidly crystallize proteins, could help make protein drugs more affordable and accessible, especially in developing countries. (Massachusetts Institute of Technology, 2/28)
Perspectives: Texas Judge's Upcoming Ruling On Mifepristone Not As Dire As It May Seem
Read recent commentaries about drug-cost issues.
Slate:
Actually, One Texas Judge Is Not the Final Decision-Maker on Medication Abortion
Despite the barrage of predictions that this case could ban mifepristone and take it off the market, there are several basic legal principles suggesting that Judge Kacsmaryk’s power is limited and that a ruling for the plaintiffs will not necessarily change much at all with medication abortion. (David S. Cohen, Greer Donley and Rachel Rebouche, 2/28)
Bloomberg:
Lawsuits Over Abortion Pill Mifepristone Are Legal Gambles
As a Texas federal judge mulls whether to halt the Food and Drug Administration’s longstanding approval of an abortion pill, 12 liberal states have filed a separate lawsuit in a federal district court in Washington State that seeks to force the FDA to drop some restrictions on the drug. (Noah Feldman, 2/28)
Also —
New England Journal of Medicine:
The Promise And Perils Of Psychedelics
In this episode of “Intention to Treat,” a study participant and a long-time investigator of hallucinogenic drugs for psychiatric conditions illuminate the effects of psilocybin in patients with depression. (2/23)
Stat:
Redefining Sustainability For The Pharmaceutical Industry
Access to pharmaceutical products and health care services should be sustainable for everyone, regardless of where they live, and sustainability efforts should focus on long-term investment in creating health equity. (Jayasree K. Iyer and Pat Garcia-Gonzalez, 2/28)
Bloomberg:
Pfizer-Seagen M&A Could Be The Deal Investors Have Been Craving
Pfizer Inc. is reportedly working on a deal that could finally satisfy investors’ cravings for a big acquisition. Last night, the Wall Street Journal reported that the pharma company is in very early talks to acquire Seagen Inc. for more than $30 billion, a deal that would instantly add four approved cancer drugs to its portfolio. (Lisa Jarvis, 2/27)
Viewpoints: Our Organ Donation System Is Broken; To Mask Or Not To Mask?
Editorial writers tackle these public health issues.
USA Today:
US Organ Donation System Is Deadly Monopoly. We Must Break It Up
In late December, my friend Tonya Ingram – a brilliant poet, surfer, advocate, cat auntie and "Price Is Right" contestant – died waiting for a kidney transplant. She was 31. Before she died, she used her voice to help call for the breakup of the monopoly in charge of the U.S. organ donation system – because its failures are "killing patients." (Jennifer Erickson, 3/1)
Chicago Tribune:
What Is A Reasonable Approach To Masking Right Now?
In medicine as elsewhere in life, if you ask the wrong question, you’re likely to get the wrong answer. So if the question is, “Do masks worn outside medical settings work to protect against COVID-19 and respiratory diseases?” — or its politically charged companion, “Do you believe in masks?” — don’t be surprised if the answers you receive are simplistic or wrong. (Cory Franklin and Robert Weinstein, 2/28)
Chicago Tribune:
How An Ideologically Blinded Media Failed To Take The COVID-19 Lab-Leak Theory Seriously
Citing a classified intelligence report provided to members of Congress, the Wall Street Journal reported Sunday that the Energy Department has now concluded with “low confidence” that the COVID-19 pandemic most likely began after an unintentional laboratory leak in China. (2/28)
Dallas Morning News:
Health Care Policies In Texas Are Hurting The State’s Business-Friendly Reputation
Texas’ out-of-control health care prices are borne by families and businesses and are a crisis for both. Individual patients are dealing with higher prices that sometimes venture into the obscene. It is not hard to find health care horror stories in Texas: See the family billed $54,000 for a COVID test or the $41,000 hip replacement surgery that costs less than half of that out of state. (Mia McCord, 3/1)
Stat:
FDA Needs To Build In More Flexibility For Rare Disease Trials
My toddler, Wheeler, will probably not live to adulthood. Juvenile Batten disease — he has the type known as CLN3 — is stealing his childhood. And then this rare disease will steal my child. (Judy Stecker, 2/28)
Stat:
An Intimate Look At The Impact Of Dementia On Caregivers
Dementia thoroughly altered my dad — and our family — and taught me just how hard it can be to care for someone with dementia. When I don’t understand something, my impulse as a photojournalist is to do a story about it. That instinct, by way of a Facebook group for caregivers of people with dementia, connected me with Leandra and George Manos, whose lives I have been chronicling since the spring of 2021. (Steven G. Smith, 2/28)
The CT Mirror:
CT's Legislature Must Act To Prevent Health Care Deserts
Our 2023 Connecticut Legislature has been given the task of considering recommendations and bills impacting who will live and who will die in the coming year. We were one ten states nationally chosen in December 2021 to participate in a collaboration between the Office of Health Strategy (OHS) and the Department of Public Health (DPH) in the Strategies to Repair Equity and Transform Community Health Initiative (STRETCH). (Brenda Buchbinder, 3/1)
Stat:
Environmental Justice Index Institutionalizes Climate Apartheid
The U.S. Department of Health and Human Services has for decades ignored its responsibility to enforce civil rights laws, as I argued last year in a First Opinion essay. Doing nothing to protect minority populations from inequitable health harms resulting from the health care industry’s greenhouse gas emissions constitutes environmental and institutional racism. HHS has now chosen to make matters worse by creating an Environmental Justice Index (EJI) that will do many things — except provide environmental justice. (David Introcaso, 3/1)