(WASHINGTON) — Nursing homes that accept Medicaid and Medicare must adhere to new federally required staffing levels in order to keep receiving taxpayer money, according to a rule announced Friday by the Biden administration that would apply to some 15,000 centers.
It’s an unprecedented move by the federal government aimed at improving care for more than 1.2 million Americans.
Under Biden’s plan, a registered nurse must be on-site at all times and spend a minimum of .55 hours — about 33 minutes — of care per resident a day. A nursing aide would be needed to provide another 2.45 hours of care to each resident.
“Establishing minimum staffing standards for nursing homes will improve resident safety,” Health Secretary Xavier Becerra said in a statement. “When facilities are understaffed, residents suffer.”
The new rule, which requires public comment and could take years before it takes effect, is expected to receive pushback from the industry. Nursing homes have long struggled with staffing shortages, exacerbated by pandemic restrictions, vaccine mandates, grueling work and lower pay compared to other health sector jobs.
Biden’s plan would include $75 million in financial incentives for nursing home staff, including tuition reimbursement and scholarships.
The idea of mandated staff levels was a promise Biden made in his 2022 State of the Union, in which the president blamed the industry’s problems on investors who cared more about profits than caring for patients.
“As Wall Street firms take over more nursing homes, quality in those homes has gone down and costs have gone up,” he said. “That ends on my watch. “
“Medicare is going to set higher standards for nursing homes and make sure your loved ones get the care they deserve and expect,” he added.
ABC News’ Cheyenne Haslett contributed to this report.
(NEW YORK) — Fifteen years ago, Brian and Kathy Haugen lost their son Taylor while he was playing football for his high school team.
The wide receiver took a hit to his abdomen by two defenders and didn’t get up for a few minutes. After he made it to the sideline, coaches saw he still wasn’t well and called an ambulance.
Doctors later determined Taylor had internal bleeding and he died in the hospital.
“When I heard that his liver had multiple lacerations, I was very concerned that that was not repairable and it wasn’t,” Brian Haugen, a veteran, told ABC News. “And when they finally came to me [they] said, he’s pretty much gone.”
The boy’s parents said they wanted to do something to raise awareness over safety issues and let other parents know there are options to better protect their kids so they started a non-profit group and program, the Youth Equipment for Sports Safety.
The program has helped schools learn about the dangers of abdominal injuries and provided students with newer protective shirts that specifically protect that part of the body.
“It starts with a compression shirt that needs to be tight on the body,” Brian Haugen said. “So even if you were to hit somebody in the ribs with a punch, all they’re going to feel on the side of their body is just pressure.”
The couple said their organization has provided over 7,000 student-athletes with the equipment in 18 states. Recently they helped out Taylor’s school, Niceville High School in Florida.
“It was over 170 players and that was very rewarding for Brian and me,” Kathy Haugen said. “It’s almost a matter of continuing his legacy and continuing the story about what happened.”
(NEW YORK) — Borax, a white, powdery substance, has long been a staple in many households as a cleaning agent and laundry detergent booster.
Now, the substance is making the rounds on social media with some people promoting it as a health booster — a trend that doctors say is dangerous.
“As a doctor, I am telling you, very explicitly, do not ever drink [borax] in any amount,” said Dr. Jennifer Ashton, ABC News chief medical correspondent and a board-certified OB-GYN. “It is a toxin. It is a poison.”
People sharing the trend on social media have suggested drinking or eating borax as a nutritional supplement that can help reduce inflammation and cleanse the body.
According to Ashton, borax is not only unsafe to consume, it is not needed, as the body has its own methods of cleansing itself naturally.
“Our skin, our lungs, our kidneys, our GI tract, our liver are constantly cleansing the body,” Ashton said. “That’s how brilliant the body is in terms of a physical machine, so you don’t really need any other ingredients to do that.”
Ashton added that lifestyle behaviors like exercise, diet, water consumption and smoking can increase or decrease inflammation in the body.
She said healthy behaviors are what people should focus on if they want to reduce inflammation and improve their health.
“The natural things that we can do to augment those processes, like trying to be in an area where there’s clean air, trying to get cardiovascular exercise or being active on a day to day basis, not smoking or inhaling anything into our lungs that is not clean and pure, those things are all smart. They make sense,” Ashton said.
When it comes to a trend like consuming borax to reduce inflammation, Ashton noted, “The risk is significant and there is is zero benefit.”
Exposure to borax — a combination of boron, sodium, and oxygen — may lead to symptoms including eye irritation, trouble breathing, cough and nosebleed, according to the U.S. Centers for Disease Control and Prevention.
Dr. Darien Sutton, an ABC News medical contributor and a board-certified emergency medicine physician, also noted that at high levels, borax can cause renal failure, kidney failure and death.
“[The symptoms] can start very much as nausea, vomiting, diarrhea,” Sutton said, adding, “I can see how [borax] can look very unassuming and not harmful, but in reality it truly is, especially if you have a higher risk that you may not be aware of until you land yourself in the emergency room.”
Sutton said that when it comes to health advice on social media, it’s important to check and double check sources.
“I do believe that there is value in social media in providing education, but I’m always the one that cross-checks information, makes sure that my source is valid,” Sutton said. “And if you have any suspicion, just try not to do it before you check.”
Both Sutton and Ashton also stressed that people should always first consult with a health care provider.
(NEW YORK) — The FDA has sent warning letters to three formula companies, red-flagging concerns about serious quality control issues at some manufacturing facilities.
The warning letters were all sent Wednesday to Reckitt/Mead Johnson and Perrigo — two long-dominating industry forces — and ByHeart, a relative newcomer to a previously hyperconcentrated market. All three companies had jumped in to ramp up their manufacturing amid an urgent baby formula shortage last year in the wake of major recalls at Abbott, one of the nation’s major suppliers.
ABC News was first to report last summer that several major formula makers other than Abbott had also struggled with contamination concerns, particularly with the bacteria Cronobacter sakazakii — and that those other formula makers had been warned by regulators for subpar conditions and critical equipment deficiencies at the time.
Alongside the publication of new warning letters, the FDA also reassured Americans that it believes prior recalls of baby formula products were “effective in removing the potentially contaminated batches.” The agency said parents and caregivers do not need to discard or avoid purchasing formula at this time.
Cronobacter can be widely found in the environment — but in infants, it can be deadly. Its discovery inside Abbott’s Sturgis, Michigan, plant last year prompted a massive voluntary formula recall in February 2022 after four babies who had consumed Abbott’s formula contracted a Cronobacter infection.
Two of the infants subsequently died, though Abbott maintains no conclusive evidence has proven its formula caused the babies’ illnesses. But Abbott’s ultimate shutdown ricocheted from coast to coast, leaving a serious void in the market and forcing families to face empty shelves and scramble for alternatives for months.
Numerous congressional hearings demanded answers from Abbott and the FDA’s leadership on why more hadn’t been done sooner to identify and fix the issue before it got so bad.
But Abbott has not been alone in facing those operational and contamination concerns.
After previous tests had found Cronobacter, FDA investigators say they have found “significant violations” during inspections ranging from the fall of 2022 through mid-February 2023 inside Reckitt/Mead Johnson, Perrigo and ByHeart facilities, including substandard processes or conditions that could help more pathogens fester.
“For over 130 years, Perrigo has been committed to meeting the needs of consumers, parents and caregivers—and the quality and safety of our products is our highest priority,” Perrigo said in a statement obtained by ABC News. “We have rigorous procedures throughout our infant formula manufacturing processes and every batch of infant formula is tested to ensure it meets stringent nutritional, safety, quality, and U.S. Food & Drug Administration regulatory requirements.”
“The letter Perrigo received pertained only to its infant formula manufacturing facility located in Wisconsin, which Perrigo acquired from Nestle on November 1, 2022, the statement continued. “This letter relates to a routine inspection by the FDA which began on March 6, 2023 and references FDA’s March 8, 2023 communication to the infant formula industry outlining its evolving regulatory expectations. We are in the process of carefully reviewing FDA’s letter and plan to work closely with the agency.”
The new warning letters detail some of the same concerns that ABC News was first to report last year. And though the companies took corrective actions, the agency said more is needed after these recent inspections.
The letters describe multiple occasions where the FDA says finished formula tested positive for Cronobacter and instances where the companies had failed to sufficiently investigate the contamination’s source and prevent it from happening again.
In some instances, the companies failed to consider “other potential sources of contamination,” the FDA said.
In Reckitt/Mead Johnson’s letter, investigators note the company’s “root cause analysis did not consider other potential sources of contamination, such as a history of several internal cracks of varying lengths identified throughout your dryer system, multiple water leaks at your facility, or the standing piles of spilled infant formula product at your facility,” emphasizing that the company’s investigation “did not consider all potential sources of contamination.”
FDA’s findings at Reckitt’s facility came amid months where the company had also found Cronobacter in “high and critical hygiene zones” of their facility’s environment — from July 2022 to February 2023.
Reckitt also found Cronobacter in their finished formula product at multiple facilities in the fall of 2022.
In February 2023, as ABC reported at the time, Reckitt issued a voluntary recall for two of their batches.
In a statement to ABC News, Reckitt/Mead Johnson Nutrition said “the safety of babies is of the utmost importance to us and we can confirm that all of our infant formula products continue to meet the highest FDA standards for safety and quality. “The FDA’s communication is part of its enhanced regulatory oversight and does not relate to any new concerns or issues, as they reflect findings from previous inspections. The company added that it is “confident in the rigor of the programs we have in place to ensure the safety of every infant formula product we ship.”
In the new warning letter sent to Perrigo, the FDA details that Cronobacter had been identified in finished formula products on multiple occasions by the company: in two products “during a continuous production campaign that ran from Oct. 23, 2022, to Nov. 2, 2022,” another that ran from Jan. 3, 2023, through Jan. 18, 2023, in which another batch formula product tested positive, and another that ran from March 26, 2023 through April 5, 2023, in which another batch of product tested positive.
FDA investigators say they also found Cronobacter from swabbing their facility’s environment this March — noting in their letter that this “was not the first time” they had found it at that facility.
“The detection of C. sakazakii in your facility across multiple independent inspections is significant in that it demonstrates your sanitation procedures have been inadequate to significantly minimize or prevent the presence of C. sakazakii in your facility,” the FDA writes to Perrigo. “Once C. sakazakii is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food contact surfaces and finished product.”
In March 2023, Perrigo also issued a voluntary recall for some of their formula due to potential Cronobacter contamination, a recall which the FDA says they believe was “effective.”
Cronobacter was also found in ByHeart’s finished formula which they flagged in October 2022. They issued a voluntary recall in December 2022, blaming the positive sample on their “third-party packaging facility.”
In their warning letter to ByHeart, the FDA also notes that various leaks were found in the facility, one in the skylight installed on the roof in June 2022, and another in a worn sealant “around the louver” in a Dryer Tower in December 2022 after “heavy wind and rain.”
During environmental swabbing conducted on the same day the leak was identified, four swabs detected Cronobacter in the dryer tower.
“Despite having a leak in December and then detecting Cronobacter spp. via environmental swabbing following the leak, the root cause analysis never considered or evaluated whether the leak may have contributed to the contamination,” the FDA’s letter said.
“We commend the FDA for its efforts to unify the industry’s ongoing work to elevate manufacturing standards and support the Agency’s enhanced oversight,” a ByHeart spokesperson said in a statement to ABC News. “Providing safe and high-quality infant formula continues to be our top priority and we can assure our customers that no distributed ByHeart product has tested positive for contaminants. There is no disruption to ByHeart’s manufacturing and we currently have three production plants across the US that are operating to meet the demand for our formula.”
The companies now have 15 days to respond to the warning letters.
(RICHMOND, Va.) — Health officials in Virginia have announced the state is experiencing an outbreak of rare, but serious meningococcal disease.
Twenty-seven cases have been identified since June 2022, which is three times higher than the expected number of cases during this period, according to the Virginia Department of Health. Of those cases, five people have died from complications due to the disease.
Most of the patients are Black or African American adults between ages 30 and 60, but no other information on the patients was available, the health department said. Twenty-six of the 27 patients were not vaccinated against meningococcal disease.
No common risk factor has been identified, but the bacteria share common genetic sequencing, according to the VDH.
Infections have been reported in eastern, central and southwest Virginia, with most being in the eastern part of the state. That leaves the department to initially believe it was a regional outbreak when it was first announced in September 2022.
Despite the outbreak, officials say the risk to the general public in Virginia is low.
Meningococcal disease is a rare illness caused by the bacteria Neisseria meningitidis, according to the Centers for Disease Control and Prevention. There are six types of the bacteria that cause most diseases around the world, with type Y being responsible for the Virginia outbreak.
The bacteria are spread by coming into contact with an infected person’s saliva or spit, such as through coughing, kissing, sharing items or sneezing near someone’s face. Sometimes the bacteria also spread through prolonged general contact with an infected person.
The illness can often turn severe and lead to meningitis, which is an inflammation of the lining of the brain and spinal cord, or septicemia, a bloodstream infection.
Symptoms included headache, fever, stiff neck, nausea, vomiting, sensitivity to light and — if the disease gets into the bloodstream — a dark purple rash.
Meningococcal disease can be difficult to diagnose because many symptoms resemble other illnesses, the CDC said. To diagnose the disease, samples of blood or fluid near the spinal cord are collected and sent to a laboratory to detect bacteria.
Antibiotics can treat meningococcal disease, but treatment needs to be started as soon as possible to reduce the risk of complications, according to the CDC.
Between 10 and 15 in 100 people with meningococcal disease die and one in five have long-term disabilities, including deafness, loss of limb or libs, brain damage and nervous system problems, the CDC said.
The Virginia Department of Health is recommending that during the outbreak, and in general, residents not share personal items, practice good hand hygiene, avoiding contact with those who are sick and to seek care immediately if they are experiencing symptoms of meningococcal disease.
The department also advised that teenagers receive the meningococcal conjugate vaccine (MenACWY) as scheduled at 11 or 12 years old and a booster dose at 15 or 16 years old. The MenACWY vaccine protects against the three types of bacteria that most commonly cause meningococcal disease in the U.S.
The Virginia Department of Health did not immediately reply to ABC News’ request for comment.
(NEW YORK) — Every month, Dawn LaGuerre has to decide which bills she’s going to pay or if she needs to cut back on groceries to be able to afford her monthly medications.
The 63-year-old from Utica, New York — 90 miles northwest of Albany — takes multiple drugs including Januvia and Novalog to manage her type 2 diabetes. Her husband, David, 61, also takes Januvia.
But her prescriptions have increased from $100 monthly to between $350 and $450 a month, leaving the couple to make tough financial decisions.
“Oftentimes, we do have to decide to pay a bill later, whether it’s my water bill or my electric bill, because I need those medications,” she told ABC News. “And without them, my health would be even more severely compromised. I can’t do without them…We really don’t have any discretionary money, and it’s putting us in the hole.”
LaGuerre’s circumstance is not uncommon — lowering prescription drug costs has become a bipartisan rallying cry for voters over the last few years. But this week, that movement saw a key victory that might bring some relief to LaGuerre and millions of other Americans.
For the first time, the Biden administration announced Tuesday that it would begin direct price negotiations on 10 widely-used drugs under Medicare, an attempt to drive down out-of-pocket costs for seniors.
The list includes medications for diabetes, heart failure and blood cancers including Eliquis, Enbrel, Entresto, Farxiga, Fiasp, Imbruvica, Jardiance, Stelara and Xarelto, as well as Januvia and NovoLog.
According to the U.S. Department of Health & Human Services, Medicare recipients who take any of the 10 drugs paid $3.4 billion in out-of-pocket costs in 2022.
President Joe Biden said the negotiated prices — which will go into effect in 2026 — will help lower costs for nine million Americans. The administration also plans to negotiate more drug prices through 2029, eventually expanding to 60 different medications.
LaGuerre said she feels the policy is throwing her and her family a lifeline.
“I’ll be having a little bit more money to pay toward those food items that we have to decide on, and I’ll be able to pay a lot of my bills with a lot more regularity without skipping them,” she said. “It’s really a big deal and for us, that would really be monumental because it would give us some kind of hope.”
The policy would also help people like David Mitchell, the founder of the group Patients for Affordable Drugs, and a cancer patient who relies on one of the drugs named Tuesday for lifesaving treatment.
He told ABC News he takes Eliquis, which treats and prevents blood clots. Annually, it costs $7,000 out of pocket, and since he pays so much money for other drugs, he actually buys a generic version from Canada that costs $1,700 per year.
“For people like me who take a drug like Eliquis, or a blood thinner, the potential savings could be thousands of dollars a year, and millions of people take Eliquis in this country,” he said.
Pharmaceutical companies have one month to decide whether they want to participate in negotiations, or risk facing a financial penalty. The penalty would be lifted, but only if the medication Is removed from the Medicare program completely.
Many of the drugmakers — including Bristol-Meyers Squibb, which manufactures Eliquis, Janssen Pharmaceuticals, which manufactures Xarelto and Merck, which manufactures Januvia — have all filed lawsuits, arguing the program violates the First and Fifth amendments.
In statements, several companies argued that lowering drug prices would hurt innovation and new drug development.
“The Inflation Reduction Act’s price-setting provisions are bad policy that will stifle the U.S. biopharmaceutical sector’s research and development, and have potentially devastating consequences for the millions of patients who need new therapeutic options,” Merck said in a statement to ABC News.
In fact, their innovation is in his best interest, Mitchell said, arguing that he wouldn’t push for price negotiations if he believed it would alter his treatment success.
“I have an incurable blood cancer, meaning no drug works forever for me,” Mitchell said. “I need them to invent new drugs that are different and have a different mechanism of action if I’m going to live as long as I hope to. That’s a fact. I would not cut off my nose despite my face. I’m not interested in dying from cancer.”
LaGuerre said if these medication prices don’t get negotiated down and those new prices don’t go into effect, she’s running out of options for how to pay for her medications and her living expenses.
“Somewhere down the road, I’m gonna have to make an incalculable decision, I may have to move out of my house, and try to find a cheaper apartment just so that me and my husband can afford our medicines,” she said. “I can’t afford to do without them. I think there’s enough skin in the game for [pharmaceutical companies] to be able to negotiate those Medicare costs so that all of us can have a chance at living.”
Brittany Murray/MediaNews Group/Long Beach Press-Telegram via Getty Images
(NEW YORK) — The overdose reversal drug Narcan will be available for over-the-counter purchase starting in September, its manufacturer announced Wednesday.
Biotech company Emergent BioSolutions Inc. said the nasal spray has been shipped to pharmacies, drugstores and grocery stores as well as online retailers with a suggested price of $44.99 for a two-dose box.
It comes five months after the U.S. Food and Drug Administration approved Narcan to be distributed without a prescription — a milestone advocates have said will make it easier to save lives amid the ongoing opioid epidemic that claimed more than 100,000 American lives in 2021.
The majority of these deaths were due to opioids, particularly synthetic opioids such as fentanyl, which is about 100 times stronger than morphine.
According to Emergent BioSolutions, approximately one life was lost to an opioid overdose every seven minutes in the U.S. last year.
Narcan comes in 4-milligram doses and is sprayed directly into the nostrils of someone experiencing an opioid overdose. The main ingredient in the medication — naloxone — blocks the effects of opioids and can quickly restore breathing.
Anyone at risk or who knows someone at risk for an opioid overdose should carry naloxone or keep it in their home, the Centers for Disease Control and Prevention recommends. It is safe for bystanders to administer the drug to anyone who appears to be experiencing an overdose and will not hurt them if they are not actually overdosing, the CDC said.
While nearly 17 million doses were distributed in the U.S. in 2021 — mostly through local health departments, first responders, schools and other organizations — harm reduction groups have been pushing for easier access to naloxone, particularly in underserved communities.
“A steadfast commitment to expanding access to naloxone has always been at the forefront of our work to help save lives and we’re proud to bring NARCAN Nasal Spray to many, many more places,” Paul Williams, senior vice president of products business at Emergent BioSolutions, said in a statement.
Walgreens told ABC News Narcan will be available in stores and online as soon as Sept. 5, with nationwide availability on Sept. 7, and that it will be sold at the suggested retail price. Walmart said it will be available the first week of September and Kroger Health told ABC News it will be carrying Narcan but did not give a date for when it will be available.
ΑBC News has also reached out to CVS Health and Rite Aid to see if or when Narcan will be made available at their stores.
(NEW YORK) — Late last week, the Centers for Disease Control and Prevention signaled it expects to have the updated COVID vaccine available by mid-September, along with a likely recommendation that everyone should get the latest booster shot, according to U.S. health officials.
The announcement comes as COVID hospitalizations increased for the sixth consecutive week, according to CDC data released Monday. For the week ending Aug. 19, hospitalizations rose by 18.8% to 15,067 — similar to levels seen in April. Still, COVID metrics remain at historic lows, public experts have said.
But at least one expert is urging the country to take COVID more seriously — Dr. Deborah Birx, who served as the White House Coronavirus Response Coordinator under former President Donald Trump.
Birx spoke to ABC News’ podcast “START HERE” about why she says the government is living in “a bit of a fantasy world” when it comes to the COVID-19 response. Birx also explains why she believes that next month’s vaccine booster is coming weeks too late and is arguing that seasonal booster shots should be made available more quickly. She also addressed criticism she didn’t combat misinformation from Trump during her time in the White House.
BRAD MIELKE: Dr. Deborah Birx is here, you remember that she served under President Trump as the White House Coronavirus Response Coordination Director in 2020. You probably remember her standing alongside Dr. Anthony Fauci, explaining what Americans should and shouldn’t be doing when we were all so confused.
Dr. Birx, thank you so much for being with us.
DEBORAH BIRX: Happy to be with you.
MIELKE: Hey so, let’s get right into it. How serious is this COVID surge that we’re seeing right now, in your eyes?
BIRX: Well, I loved your introduction, because you laid it out perfectly. So, what does it mean when someone recommends a fall vaccination? It means that you’re ignoring the summer wave. And we’ve had the summer wave in 2020, 2021, 2022 and now 2023. It is predictable. It’s what COVID does. It has been persistent, but we’ve had these waves, and so we’ve never gotten to zero. The hospital admissions have never gone to zero.
Now we’re living in this, a bit of a fantasy world, where we’re pretending that COVID is not relevant. But I can tell you, if you can hear my voice and you know two or three people who have COVID, that means that 5 to 10% of your friends already have COVID. That means that there is a lot of COVID out there, and we’re not testing for it and we’re not telling people to get tested.
And thank goodness you tested and protected your wife, because that’s what it’s going to come down to now, we all have to enhance our responsibility to protect those in our family.
MIELKE: As far as the boosters, then? This booster shot. Are these boosters coming too late?
BIRX: Well, the important thing is, this is the booster that would have been appropriate for the summer wave. This booster is most likely not going to work with the winter wave, because we already have a pretty significant escape mutant or escape variant out there that’s beginning, just like the current variant, began like eight weeks ago. We are already beginning to see some evidence of a new variant for which the vaccine probably is not well matched. So, the whole point of doing mRNA technology was to be able to switch out –
MIELKE: These are the mRNA vaccines that you can tailor make?
BIRX: Yes. So right now, we should be making the vaccine against this very new variant, the b2.86, so that it is ready in January to really combat what we know will be the winter wave. Now, what’s interesting is this summer wave and each summer wave seems to be coming about two weeks later, and that resulted in our winter wave last year being in January rather than primarily December. And so we should expect that late December, early January wave. And so we should be making vaccines right now for that wave.
MIELKE: Why aren’t we? ‘Cause I feel like the mRNA vaccines were supposed to be this game changer, where like, yeah, now when something happens we can bust out a new one within weeks. But it still seems like the flu shot, like get your flu shot once a year.
BIRX: Exactly, and what a mistake that is. Because let’s remember, the protection against infection is extraordinarily short-lived. And so the protection from either prior infection or the vaccine is short-lived. In some cases, maybe as short as four weeks. In other cases, it may be 3 to 6 months. But we know across the board, natural immunity and vaccine-induced immunity against infection wanes substantially in three to six months.
And so if you are living with immunosuppressed individuals or if you have people in your household over 70, your vaccination and their vaccinations need to be at a different rate than the general population.
And so right now we should be making the b2.86 variant vaccine to be ready in December to immunize people over 70 and those with immunodeficiencies, because this is the only way we’re going to ensure that those that are most susceptible – we know precisely who those are, it hasn’t changed since 2020 – and to make sure that we have testing in those households so that they can protect their family members, that we tell them when the surges are coming. I mean, we have totally ignored this wave.
Finally, hospitalizations. Huge mistake to measure hospitalizations as really your sole surveillance, because by the time you see hospitalizations in your area, the virus has been circulating for four to six weeks.
MIELKE: Right, for somebody to have gotten COVID and then for it to progress to the point where they go into the emergency room, by then, the entire community might have it.
BIRX: Correct.
MIELKE: Well then, and I should say, it’s not clear these boosters won’t work against these oncoming variants, you’re just saying [the oncoming variants] weren’t part of these clinical trials, so we don’t know. We also don’t know for a fact that this variant will take over.. But I guess my question still remains – Why? Why aren’t more boosters being cranked out? And if it’s a political concern, where maybe the administration is thinking, “Ugh, no one wants to take more shots, COVID is a political liability for us. Let’s just do it once a year like the flu.” Is that the reason?
BIRX: I think we wanted to make it like flu, because that was easier. But it’s never going to be like flu. It stays with us in between the waves. We have a summer wave. We have a winter wave. It makes people much sicker than flu. Many more people die from it than flu. And by the way, flu does not have this level of long COVID and these long side effects that we see with COVID. So let’s just all agree it’s not flu. It will never be flu. Following it and surveying for it like we do for flu will never be adequate in this country.
I believe, if the federal government said to the private sector, “We need better monoclonal antibodies, we need more antivirals, and we need a vaccine against the new variant that’s coming,” the private sector would do it like they did four years ago. It’s not that they need guarantees from the government that they would pay for it, because now insurance is paying for it.
So what the federal government needs to do is lay out the plan that says, “We’re not done with COVID, COVID’s not done with us. 250,000 Americans died in 2022. We’ve got to do a better job in 2023. And this is part of our better job.”
MIELKE: The CDC says it currently has no plans, there’s no talk about bringing back mask mandates of any kind. We’ve talked about vaccines, antibodies, testing. Is that the right call in your eyes to not make masks part of the conversation going forward?
BIRX: You know, not only should it be part of the conversation, but it should be very clear when there is the need to use it and what families should be alerted to using it. But let’s be clear, a lot of our elderly, particularly those in memory care, really can’t mask. And that means the people around them need to test and mask.
I’m all for not mandating, but educating. But then you have to give people the tools and the data that they need in order to make their decisions and empower them to make the decisions that’s right for their family. And we’re just not alerting people to when they need to worry.
MIELKE: So it sounds like, Dr. Birx, like you’re saying, like this is something to take seriously. We haven’t really taken it seriously enough. There are people living in what you kind of described as like a fantasy world, where we’re just acting like COVID doesn’t exist because it’s just been too long. And then that should stop. But then I got to imagine I’m going to hear a listener screaming into their phone as they listen to this, “Dr. Birx, you stood next to President Trump as he was saying misinformation, outright misinformation about COVID. Why didn’t you step in front of him at the microphone right then? Why is this the line coming from you now that you no longer have this official capacity?”
BIRX: Because my line was coming through the whole time. I’ve known Dr. Fauci for a long time. Dr. Fauci was the outside voice, and I was the inside voice. Someone had to be inside the White House making sure that resources were made appropriately to expand testing, to expand monoclonal and develop vaccines, and that was part of my role. We each had a role to play. If you’re referring to the bleach episode
MIELKE: I’m thinking about using disinfectant and bleach in your veins.
[The so-called “bleach episode” refers to when then-President Donald Trump said at a press conference, “And I then I see the disinfectant that knocks it out in a minute. And is there a way we can do something like that by injection inside, or almost a cleaning?”]
BIRX: So I did speak up at the end of that. What never is shown is [Trump’s] back was turned to me, and he was speaking to the DHS scientist. He was not facing me. And if you people asked me, would you have run up to the microphone? I was active-duty military. That is not within my repertoire.
Did I make sure that President Trump, NIH, FDA and CDC were alerted and that the next day President Trump said it wasn’t true and that he was joking? Yes, that’s what I could get done.
I think getting that 45 days to slow the spread, getting tests out there, getting vaccines out there and getting monoclonal [antibodies] out up there were very important. Were we all perfect? We were not.
I think my biggest regret is not letting Americans know how important they were in preventing that original COVID spread to get beyond the 12 metros that it was in, into the other 25 metros. That was all prevented by Americans really being proactive, and I think because we never called that out, people felt disempowered. And the one thing you want to do in a pandemic is really empower people that they know that their individual actions make a huge difference at the population level.
(NEW YORK) — COVID hospitalizations are continuing to increase in the United States, according to data updated Monday from the Centers for Disease Control and Prevention.
Hospitalizations rose for the sixth consecutive week, this time by 18.8% during the week ending Aug.19 to 15,067 — similar to levels seen in April of this year.
However, COVID metrics remain at historic lows, public health experts have said. Hospitalization numbers this week are about 2.5 times lower compared to the same time last year and about 5.5 times lower compared to this week in 2021.
Additionally, hospitalizations during the peak of the omicron wave in winter 2021-22 stood at more than 150,000.
Deaths slightly increased, with about 1.7% of all deaths being due to COVID last week, according to CDC data. However, COVID fatalities are similarly at record lows. Experts have warned that because deaths are a lagging indicator, cases could rise in the next few weeks.
Dr. John Segreti, an epidemiologist and the medical director of infection control and prevention at Rush University Medical Center in Chicago, told ABC News that a percentage increase may seem frightening, but the absolute numbers are rather small.
“Looking at that graph [of] hospitalizations, even though it’s on an upward trend, that’s still lower than it was last year at this time,” he said. “The fact that the numbers are going up fairly slowly, I think is a good sign.”
CDC data shows that all the circulating subvariants are related to XBB, an offshoot of the omicron variant. EG.5 currently makes up a plurality of cases in the U.S. at 20.6%, data shows.
There is a newer variant circulating known as BA.2.86. A total of 13 cases have been identified globally, including three in the U.S., according to the open global genome sequencing database GISAID.
Experts have previously told ABC News that it may be more transmissible, but there are no indications that it causes more severe disease, something echoed in a CDC risk assessment issued last week.
It comes as several institutions say they are reinstating mask mandates, at least temporarily, amid rising cases and hospitalizations.
Morris Brown College, a historically Black college and university in Atlanta, said masks would be required for at least 14 days in a letter written to faculty, staff and students by President Dr. Kevin James last week.
Additionally, Lionsgate, the entertainment company, told ABC News in a statement last weekend that certain employees at headquarters were being required to wear masks again by the LA County Department of Public Health “due to a cluster of COVID cases.”
Segreti said his hospital and others in the Chicago area are starting to discuss whether or when they will reinstitute mask mandates, but he’s unaware of any that have so far.
“We’re struggling to figure out what metric to use to determine if and when to resume masking, and there’s no perfect metric for that, especially since the end of the public health emergency declaration, the data we’re getting isn’t nearly as complete as it was before that,” he said.
Rather than a metric, the hospital is considering using a time frame, such as between November and March, to require masking, but no decisions have been made yet.
He said hospitalizations could continue to increase but the fact that enough Americans have immunity through previous infection, vaccination and boosters, means fewer people who contract COVID will be hospitalized.
“The question is, where will the peak be? Are we at the peak?” Segreti said. “It doesn’t seem like we’re at the peak right now, but the slope of the of the line is not like it was with omicron. So, if it happens, it’s going to happen fairly slowly.”
Meanwhile, pharmaceutical companies are targeting newer variants ahead of a possible uptick in numbers during fall and winter.
The CDC’s advisory committee is expected to meet on Sept. 12 to discuss new boosters targeting new COVID subvariants, making them likely to be available by mid-to-late September.
In an interview with Start Here, Dr. Deborah Birx — an advisor to former President Donald Trump during the pandemic — said she believes next month’s vaccine booster is coming weeks too late and that seasonal booster shots should be made available more quickly.
“This is the booster that would have been appropriate for the summer wave,” Birx said, adding that she predicts that by the time the shot is distributed, we may be primed for a variant that has already passed us.
(NORTH RICHLAND HILLS, Texas) — For years, Jessica Jordan of North Richland Hills, Texas, lived with debilitating pain. Her daughter, 18-year-old Brooke Lyle, remembers her mom tried to “hide the pain a lot,” but, as she told Good Morning America, she knew “something was wrong.”
“I could hardly walk. I was in a lot of pain, like everywhere,” Jordan, a mom of five, recalled to GMA. “Finally, when I was diagnosed, my body was already shutting down and it affected my kidneys because it’s a very aggressive disease if you don’t catch it right away. I did almost die when I got diagnosed but treatment and everything worked pretty good.”
That disease, Jordan explained, is granulomatosis with polyangiitis, a rare autoimmune disease she says she was diagnosed with about 12 years ago. According to the National Institutes of Health, it causes swelling and inflammation of the body’s blood vessels, and can limit blood flow to organs such as the lungs and kidneys, damaging the organs.
Jordan said that’s what happened to her. “It slowly started affecting my kidneys and then they started me on dialysis,” she said, adding that doctors told her early on that she would eventually need a kidney transplant.
The family came up with a plan to have Jordan’s twin brother, Alfred Daniel Tucker, donate a kidney to her, but that changed after he died unexpectedly on Aug. 13, 2021 from COVID-19, which also affected his organs.
When her uncle passed and her mom began dialysis treatment, Lyle said decided to donate one of her kidneys to her mom.
“I just was like, ‘OK, I’ll do it’ and that was it,” Lyle said. “I did all this research and I was like, ‘OK, I am gonna do it’ because obviously, I’m going to think about all of the terrible things that are gonna happen for doing this but there really isn’t that much I’m giving up that’s worth giving up my mom.”
At first, Jordan said she was against Lyle giving her one of her kidneys because she felt she was too young and had a long life ahead of her.
“I was like, ‘Oh, there’s no way because I know it’s a big surgery.'” Jordan said. “Maybe if she was older and already had children, I’d feel more comfortable, I guess. But I didn’t do that much research on an 18-year-old ’cause I never thought I would have an 18-year-old, and especially my daughter. But that’s one thing you have to do, of course, is just do your research.”
But Jordan eventually accepted the offer after both she and Lyle consulted their doctors and health care team.
“I would not have put my daughter in any situation that I thought it was gonna affect her later,” Jordan said. “We both spoke to counselors and they did talk to her without me to make sure she wasn’t pressured into it or anything like that, which was awesome. And I told her from the very beginning that even at the point of surgery, they even told her that if she wanted to back out, that she could.”
Lyle said she grew more comfortable with her decision as she learned more about the donation process.
“I think what really helped me be at ease with this decision was that there’s a super-low [number] of people that have died from complications of being a donor,” the high school senior said.
The mother-daughter duo both underwent successful surgeries at Baylor Scott & White All Saints Medical Center in Fort Worth, Texas on June 14. Jordan, who will have to take anti-rejection medication continually, now has three kidneys, while Lyle has one.
“She’s healthy and I’m healthy and the doctors just tell me I got such an awesome kidney,” Jordan said. “Right away, it started working and I feel it. I feel great.”
Nearly 114,000 people across the U.S. are currently waiting for an organ transplant, with just over than 95,800 of them waiting for a kidney, according to the most current data from the Organ Procurement and Transplantation Network.
Jordan and Lyle say their message to others is to “be a donor.”
“A lot of people aren’t aware. You can live with one kidney,” Jordan said. “If you can donate now, do it. If not, donate when you pass on, give life to someone else. Because you will live on like that or at least a little part of you will.”
