(WASHINGTON) — President Joe Biden has tested positive again for COVID-19, according to a letter from White House physician Dr. Kevin O’Connor.
O’Connor said Biden’s antigen test came back positive late Saturday morning after he tested negative Tuesday evening, Wednesday morning, Thursday morning and Friday morning.
This is a developing story. Please check back for updates.
(NEW YORK) — Health officials have warned since the beginning of the COVID-19 vaccine rollout that areas with lower inoculation rates are at greater risk of higher cases, hospitalizations and deaths.
In fact, studies have shown areas with low vaccination rates had as many as 2.4 more new COVID-19 infections per 100,000 people compared to areas with high vaccination rates.
But states — and counties — with little vaccine uptake are not just facing the cost of more severe complications from the virus.
There’s also the cost to the healthcare system with staff needing to call out if they get infected and not able to serve other patients due to a surge of COVID-19-related admissions.
Families living in low vaccinated areas may also suffer a cost. This could mean adults have to miss work, and potentially lose wages, because they or their children test positive for COVID. Children who also have to miss school can fall behind on their lessons.
“I think most people want to make an informed decision [about vaccination] and they have a hard time identifying the information that describes the real situation,” Dr. Jennifer Dillaha, the Arkansas Department of Health’s director for immunizations, told ABC News. “I know it’s possible for people to downplay the seriousness of the illness that they or their family members or their community could experience.”
The strain on the healthcare system
In the U.S., 67.2% of the population is fully vaccinated as of Friday, according to the Centers for Disease Control and Prevention. But the rates between states vary starkly.
Some states have broken the 80% mark. Others have barely hit 55%, data shows.
As of Friday, in Arkansas, only 55.3% of residents are fully vaccinated, according to CDC data. Dillaha said low rates put a strain on hospitals, especially during surges.
“We did see that with both the delta and the omicron surges that we had in our state, the hospitals had to take steps to increase staffing so they could take care of more people who needed hospitalization,” she said. “And it made it difficult for people who needed hospitalization, for other reasons that were not related to COVID, to get a hospital bed.”
A similar situation existed in Alabama, where only 51.9% of the population is fully vaccinated, as of Friday.
“What we saw in our hospitals is an inability to deliver routine care,” Dr. Wes Stubblefield, district medical officer for the Alabama Department of Public Health, told ABC News. “During the height of some of these pandemic peaks, we saw hospitals that were closing elective orthopedic, outpatient surgeries, elective screening procedures, other things like that, that just couldn’t be done because of the sheer volume of patients that were there.”
Health officials say patients missing preventive care visits, general medical appointments, elective surgeries, or other care could increase the risk of an illness worsening or of death from conditions that were otherwise preventable or treatable.
The CDC estimates since the pandemic began there have been 1.1 million excess deaths, or deaths that exceed the numbers of people expected to die over the same period.
Additionally, hospital costs increased because administrators had to pay their staff higher wages, according to the health departments.
Because of staffing shortages — particularly of nurses — whether because there were not enough nurses to treat the number of COVID-19 hospitalized patients or because nurses fell ill themselves and there were not enough to cover shifts, many hospitals relied on traveling nurses.
Dillaha said that because states were competing for traveling nurses, Arkansas hospitals were offering higher wages to incentivize them to work there. She said this created a disparity between the wages of traveling nurses and the full-time staff nurses that had to be addressed.
“The hospitals had to address that by increasing the amount they paid for people who did not travel in order to encourage them to stay on the job,” she said.
Stubblefield said Alabama hospitals that had trouble paying staff competitive wages after paying high wages for nursing staff saw many people resign from their jobs.
“Having to pay very high rates for temporary nursing staff, we’ve seen turnover in the hospitals,” he said.
The cost to families
Doctors also stressed that families living in areas with low vaccination rates can suffer a cost — financially and emotionally.
Adults who contract the virus are forced to miss work, which can result in lost wages for those who are paid hourly and are not salaried.
“Where I live, we have a fair number of jobs where they really don’t have a lot of capacity to miss work,” Stubblefield said. “These jobs are very hard to come by. They pay relatively well for that kind of a job, but then they don’t get a lot of time off and getting sick can be very difficult for them.”
If they identify as one of the one in five Americans who develop long COVID, which is when symptoms last more than four weeks after recovering, that can also result in lost wages from missing time off work.
“If you have persistent symptoms over a long period of time, which makes it difficult or impossible for them to go back to work or go back to school, that is a hardship for families as well,” Dillaha said.
Parents may also be forced to miss work if they have a child who gets sick and can’t attend school or daycare, or if their classroom or school closes due to an outbreak and they must switch to remote learning.
To drive up vaccination rates — and prevent as many days lost of school and work as possible — Stubblefield said it’s important to try to have individual conversations with those who are vaccine hesitant, something he did as a pediatrician for 14 years before joining the health department less than a year ago.
“There’s a lot to be said about not trying to get into a long debate,” he said. “The main thing is we would talk about our own personal experience, how we would do this for our own families, and we wouldn’t do anything, or suggest or recommend anything, that we wouldn’t recommend for ourselves or our own families.”
He continued, “Hopefully they would have a relationship with us so that we could have a conversation, a civil conversation, and we could come to an agreement and whether that agreement is to reconsider [vaccination] at the next visit or then to make that decision [to vaccinate] and move forward.”
(NEW YORK) — One sole winning jackpot ticket was sold in a Speedway convenience store in Des Plaines, Illinois, in a historic $1.34 billion drawing, according to Mega Millions.
One ticket matched all six numbers in Friday night’s drawing. The winning numbers were 67, 45, 57, 36, 13 and the mega ball was 14.
The jackpot was initially estimated to be $1.28 billion, but had officially grown to $1.34 billion due to last-minute sales, Illinois lottery director Harold Mays said at a press briefing on Saturday.
The prize is the equivalent of $780 million in cash, he said.
Mega Millions has yet to hear from the winner, Mays said.
“We don’t know whether they even know that they won a prize. So I encourage everybody to check your ticket,” he said, noting that it could take a few weeks for a winner to come forward to “get their affairs in order.”
The winner can opt to remain anonymous, he said.
The Speedway will receive $500,000 for selling the winning ticket, according to Mays.
For only the third time in the 20-year history of the American lottery game, the big prize has reached the billion-dollar mark. The jackpot has grown to an estimated $1.28 billion — a cash value of $648.2 million — after no ticket matched all six numbers drawn Tuesday night, according to a press release from Mega Millions.
This is the second-largest jackpot in Mega Millions history, behind only the record $1.537 billion won in South Carolina on Oct. 23, 2018 — the world’s largest lottery prize ever won on a single ticket.
“We are thrilled to have witnessed one of the biggest jackpot wins in Mega Millions history. We’re eager to find out who won and look forward to congratulating the winner soon!” Ohio lottery director Pat McDonald, currently serving as lead director for the Mega Millions Consortium, said in a press release.
The jackpot has reset to $20 million for Tuesday’s drawing.
Friday night’s Mega Millions drawing marked the 30th in this jackpot run, which began on April 19.
In the 29 drawings since the Mega Millions jackpot was last won in Tennessee on April 15, there have been over 28.1 million winning tickets at all prize levels, including 42 worth $1 million or more in 17 states across the country. Four Mega Millions jackpots have been won so far this year — in California, New York, Minnesota and Tennessee.
Mega Millions jackpots start at $20 million and grow based on game sales and interest rates. Despite a surge in ticket sales, the odds of winning the big prize remain the same — 1 in 303 million.
Mega Millions tickets are $2 and can be purchased in 45 U.S. states, Washington, D.C., and the U.S. Virgin Islands. Drawings are conducted at 11 p.m. ET every Tuesday and Friday at the studios of Atlanta ABC affiliate WSB-TV, supervised by the Georgia Lottery.
Winners can either take the money as an immediate cash lump sum or in 30 annual payments over 29 years.
(NEW YORK) — Universities across the country are studying their relationship to slavery and are being called on by students to address their histories by making symbolic and financial reparations.
During the colonial era the wealth of universities, in the form of endowments and benefactors, was inextricably tied to the slave trade, numerous university presidents owned enslaved people and famous alumni such as John C. Calhoun championed the cause of slavery. Enslaved people were owned by universities and worked on campuses until the abolition of slavery.
Now, students at those institutions are organizing. They are focusing on erecting monuments, taxing endowments, creating divestment campaigns and offering alternative campus tours that highlight the university’s history of slavery. Students are also pushing schools to identify and support descendants of people enslaved by the universities.
At Brown University in Providence, Rhode Island, senior Carina Sandoval was “really hopeful” when she cast her ballot last year in the student referendum, which asked students whether they thought the university should make efforts to identify descendants of people enslaved by the institution and make some form of reparations to them.
More than 80% of the student body said yes to both measures, yet Sandoval said the university did not respond.
“A number of my co-organizers and I have been increasingly disillusioned with the referendum process, as it feels like a stalling tactic by the university,” Sandoval told ABC News. “In any case, it’s made it clear that campaigning exclusively within the university alone is ineffective.”
According to a landmark 2006 report on Brown’s history, early trustees of the university owned enslaved people, and the first building on campus, University Hall, was built by enslaved people. The Brown family, for whom the university is named, were slave traders, the report states.
“We always welcome the opportunity to engage in a direct and positive dialogue with students, and the question of reparations remains an important one that will continue to prompt exploration on campus,” a university spokesperson said in a statement provided to ABC News.
Sandoval and more than a dozen other students are part of a group called “Coalition for University Accountability,” which formed two years ago with the goal of educating students about the history and legacy of slavery at the university and passing two bills in the city government, both of which would tax the university.
One bill would allow the city to tax the university’s property “notwithstanding any charter provision,” because the university is tax-exempt in the state constitution.
A Boston Globe analysis found that taxing Brown’s properties would give the city an estimated $48 million annually.
Another bill would enable the city to tax the university endowment, which is $6.9 billion, at a maximum rate of 2%. The bill also states that the revenue can “be used only for the host’s public school district.”
Gabe Mernoff, a senior at Brown who grew up in Providence and is a member of the “Coalition for University Accountability,” said the idea of taxing the university specifically is something “you hear about all the time from people” in the city.
“We want Brown to not only be a good neighbor, but a neighbor that actively uses its resources and its vast wealth to promote social justice in Providence and Rhode Island,” said Mernoff.
“[It’s] wealth originally has been built on injustices like slavery and other forms of exploitation in subsequent centuries and today it’s gentrifying a lot,” he added.
A spokesperson for the university said in a statement, “Brown continues to believe that taxes imposed through legislative efforts impede the efforts of higher education institutions,” adding that “legislative efforts such as these tend to overlook that Brown provides extensive contributions to the community we call home in significant areas that meet public need and offset the need for greater public resources.”
On other campuses, student organizing has focused on increasing the payments many universities make voluntarily to local municipalities to compensate for the university’s tax-exempt status. These payments, called PILOT, or payment in lieu of taxes, represent a small fraction of what they would presumably “owe.”
Last year, Yale University agreed to increase its annual PILOT payments, which were approximately $13 million, by $10 million over the next five years.
Local organizer Remedy Sharif cites a multi-year organizing campaign, undertaken by community members, teachers’ unions, graduate and undergraduate students, with the slogans “Pay Your Fair Share” and “Yale Respect New Haven,” as the reason for this decision.
“When you’re facing a 40-plus billion-dollar multinational corporation, it takes a lot of power,” said Sharif. “Our community was building that power and applying that pressure, but we also needed those allies on the inside.”
A spokesperson for the university issued a statement saying, “for decades, Yale has regularly increased its voluntary payments to New Haven. Our most recent increase is the largest yet,” adding that “these contributions reflect the continued evolution of our strong commitment to, and partnership with, our hometown.”
The most recent data published by the Lincoln Institute of Land Policy shows that 70 universities across the country make PILOT-type payments.
Another strategy that is being used by student organizers is calling for universities to divest endowments from certain industries.
At Harvard University, where the administration recently announced a $100 million reparations fund, student and community organizers have been focused on getting the university to divest from the prison industry.
The Harvard Prison Divestment Campaign filed a lawsuit against the university in 2020, alleging that the university had engaged in “untrue and misleading advertising” because “at the time that President Drew Faust publicy [sic] promised to understand and adress [sic] Harvard’s complicitly [sic] with slavery, Defendant Harvard Corporation was invested in and profiting off of the continued enslavement of mostly Black and brown peoples in prison,” the lawsuit reads.
The case was dismissed last year, with the court deciding that the six Harvard students who filed the lawsuit “lack[ed] standing to challenge the investment decisions at issue in this suit.”
In the most recent update from the Harvard & the Legacy of Slavery implementation committee, Harvard professor and committee chair Martha Minow said, “we are immersed in listening to many people, gathering ideas, and moving ahead on the task of advising the president and other senior administrators, and developing suggestions for further work.”
A spokesperson for Harvard University declined a request from ABC News to comment specifically on the subject of divestment.
“Universities typically dramatically overstate the limitations on what they can use their endowments for,” said Charlie Eaton, professor of sociology at the University of California, Merced, and author of “Bankers in the Ivory Tower.” “If the university has a will to use its endowment toward racial equity it will,” said Eaton.
In 2015, both Columbia University and the University of California system announced they were divesting their endowment from the private prison industry.
At the University of Chicago, student and community organizers have demanded $1 billion in “reparations” from the university to the South Side of Chicago, as part of a multi-pronged campaign asking the university to respond to its historical ties to slavery and allegations of gentrification.
Current and former doctoral students have sought to highlight the link between the current organization, wealth and status of the University of Chicago and what is called the “Old University of Chicago,” which was founded by Illinois senator and slave owner Stephen A. Douglas, making the case that Douglas’ original endowment, generated from enslaved laborers, made the university possible.
“The University of Chicago has developed deep partnerships with our community and the City of Chicago,” a spokesperson for the University of Chicago said in a statement. “We are continuing to make far-reaching contributions to address community priorities and enhance the quality of life on the South Side.”
“The University of Chicago that exists today was founded in 1890,” the spokesperson for the university said. “The earlier university was founded by Douglas in 1856 and financially collapsed in 1886, with no endowment and its land and buildings foreclosed by creditors.”
The student organizers, calling themselves “University of Chicago Against Displacement,” also have joined with community organizations to demand a community benefits agreement, a legal contract between a real-estate developer and organizations representing residents, from the city of Chicago.
The focus of the coalition is preventing gentrification and displacement they say will be caused by building of the Obama Presidential Library in the South Side, which is currently under construction.
The city of Chicago did not respond to repeated requests from ABC News for comment.
Universities have taken down monuments to slave owners closely affiliated with the university, and erected monuments that memorialize the histories of enslaved people within the university. More than 95 universities have joined the “Universities Studying Slavery” consortium, organized by the University of Virginia.
At the University of Mississippi, Columbia University, the University of Alabama and Harvard University, visitors can go on alternative campus tours that are meant to highlight the university’s history of slavery.
Universities have published reports on their own historical ties to slavery comprising hundreds of pages, and Georgetown University has begun offering special consideration in the admissions process to descendants of enslaved people owned by the Maryland Province of Jesuits after the university officially apologized in 2017 for the sale of 272 enslaved people in 1838 to fundraise for the school.
In 2019, Georgetown students voted to create a reparations fund that would serve the descendant community. The school responded by creating a reconciliation fund, which receives minimum funding of $400,000 a year and is dedicated to “support[ing] community-based projects to benefit the Descendant community,” a spokesperson for the university said. It has also funded a charitable foundation, run by a board that includes descendants.
“We are committed to continuing to understand and respond to our involvement in the institution of slavery and ensure that our community members engage with this history and work toward racial justice,” the spokesperson added.
“There is a tradition among students going back, at least to the 1960s, of promoting racial justice,” said Robert Cohen, professor of History and Social Studies Education at New York University. “This issue of reparations, and [reckoning with the] history of slavery on the university campus, is consistent with that.”
Olivia Henry, a third-year student at Georgetown University, said she has personally connected with descendants of enslaved people sold by Georgetown University and visited the plantation in Louisiana where their ancestors labored.
Henry is involved with organizing a school supply drive for Maringouin, Louisiana, where many of the descendants live, coordinating teach-ins for fellow students to learn about Georgetown’s history, and advocating for the construction of a memorial on campus.
“The reparations are not meant to be in any way, shape or form a cop-out for meaningful engagement with the descendant community. They are a part of Georgetown and if they want access to Georgetown’s resources that should be part of their disposal,” said Henry.
“It takes sending that first message [to descendants], and just kind of hoping that people respond. And if they don’t, there’s no requirement for people to talk to me,” said Henry. “But I’m trying to have that door open.”
(NEW YORK) — For decades, the aviation industry has carried the reputation of being overtly male and white. At least 95% of the roughly 158,000 pilots employed in the United States are men, according to the Bureau of Labor Statistics.
“This is a very male-dominated industry,” said Dana Donati, a former pilot with Republic Airways.
Donati recalls being one of two females in her college aviation courses and during her early officer training.
At the height of summer travel, as airlines brace for a pilot shortage on one side and recent protests from current pilots on the other, some airlines are making efforts to attract the next generation of pilots who have been historically excluded from the industry — women and people of color.
Donati, who now serves as the CEO of United Aviate Academy, is one of those aviation professionals trying to change the system. Founded by United Airlines, the academy is a 12-month program in Phoenix, Arizona, that aims to diversify the cockpit.
The program offers a 12-month training footprint, in which students complete several certificates on private piloting, commercial piloting, instrument operations and more.
“It’s about time the industry looks at how they have historically operated,” added Donati.
The figures are stark — there are only about 200 Black women pilots in the U.S., accounting for less than 1 percent of the profession, according to Sisters of the Skies, an organization advocating for Black women pilots.
Flying has traditionally been an “elitist” profession, according to Theresa Claiborne, the first Black woman pilot in the U.S. Air Force and a United Airlines pilot.
“They did not make any provisions. So, it’s been perpetuated,” said Claiborne, who holds the rank of captain, the highest rank for commercial pilots.
Claiborne attributes flight costs and generational and economic disadvantages as significant contributors to the lack of pilots of color.
Adding the total costs for an aspiring pilot to obtain all licenses and complete 1,500 hours of flight training required by the FAA to become an airline pilot are estimated to cost nearly $100,000.
“That’s a lot of money. And financial institutions are not jumping at the bit to loan that kind of money to an aviation student,” Claiborne said. “We don’t have these long generations of pilots in the family.”
Other commercial airlines are also pushing efforts toward diversity, including Delta Airlines, which launched the Delta Propel Career Path Program. The program offers an accelerated path to the flight deck for selected students across 13 universities around the US.
“Delta’s commitment to developing a diverse workforce that is reflective of the communities we serve domestically and around the world is unwavering. This includes removing barriers and broadening recruiting funnels to help create a diverse pipeline for qualified and talented pilots to join us,” a Delta airlines spokesperson told ABC News.
In 2008, JetBlue launched Gateway University, the airline’s first pilot development program for prospective pilots and aircraft maintenance technicians.
“JetBlue is addressing the uncertainty that prevent many from pursuing their dreams and can very well meet the growing need for aviation professionals while also opening the door to underrepresented communities, including women and people of color,” a JetBlue spokesperson added.
Donati said the makeup of pilots hasn’t changed in over 20 years. “It’s time that we think differently about how we’re approaching our communities and supporting students entering this career,” she said.
Eighty percent of the inaugural class of future pilots at United Aviate Academy identify as women or people of color. In that number is Abby Awosanya, a 25-year-old first-generation Nigerian-American from Maryland. Awosanya recently obtained her private pilot license and is working to become a 787 captain for United Airlines.
“I probably would have gotten involved in aviation sooner if there was some sort of representation,” Awosanya told ABC News.
After completing her first solo flight in April, Awosanya says she’s proud to be part of the inaugural class. She says she looks forward to “changing the way the flight deck looks to better reflect the passengers who are in the cabin.”
(NEW YORK) — Some of the operational deficiencies that helped trigger the massive shutdown of Abbott Nutrition’s infant formula plant earlier this year have also been found at some other companies’ factories, according to an ABC News investigation of some of the other formula makers that have stepped in to help fill empty American grocery shelves in the midst of the critical nationwide shortage.
The pathogen that prompted those concerns, Cronobacter sakazakii, can be widely found in the environment — but in infants, it can be deadly.
Its discovery inside Abbott’s Sturgis, Michigan, plant prompted a massive voluntary formula recall in February, after four babies who had consumed Abbott’s formula contracted a Cronobacter infection. Two of the infants subsequently died, although Abbott maintains there has not been conclusive evidence that its formula caused the infant illnesses, since none of the Cronobacter strains found at their plant matched the two samples genetically sequenced from the sickened infants.
Ultimately, it was the combined findings of Cronobacter inside Abbott’s plant — along with a pattern of serious operational deficiencies and consumer complaints — which led to its closure.
Abbott’s shutdown ricocheted across the country, exacerbating the supply shortage and forcing families to scramble for alternatives in the hyper-concentrated formula market. In the wake of Abbott’s recall, other companies jumped in to ramp up manufacturing to help mitigate the strain.
Yet within the last five years, those companies — Reckitt’s Mead Johnson, Gerber, and Perrigo’s PBM — have also not been immune to operational and even contamination-related concerns.
Nearly a decade’s worth of FDA inspections obtained through the regulatory intelligence company Redica Systems and reviewed by ABC News have found the presence of Cronobacter in environmental sampling, in critical and high-hygiene areas, and even in finished product from some of these formula manufacturers’ American plants.
In some cases, investigators found crucial equipment in a state that could nurture the spread of potentially dangerous pathogens, according to inspection reports.
‘Rigorously managing the environment’
Cronobacter is exceptionally hardy, experts say. It is also “fairly common” in places like soil — but that’s exactly why “rigorously managing the environment” in formula factories and “taking proactive steps to prevent pathogens from creeping into our foods” are particularly important, food safety expert Scott Faber told ABC News.
Akin to a restaurant health inspector, the FDA performs no-notice inspections of U.S. manufacturing facilities to ensure companies are complying with manufacturing and cleanliness standards; they also perform inspections when alerted by a company that product contamination has been found — or when consumer complaints prompt a for-cause probe into whether the company is upholding an acceptable standard.
ABC News has reviewed FDA inspection documents for the three other domestic companies which, along with Abbott, have been responsible for roughly 90% of the country’s formula market.
The right set of circumstances can compound a perfect storm of risk factors for potentially dangerous pathogens to survive, experts say — and that’s especially worrisome when a contaminant like Cronobacter lurks where food is made for babies, who are among those most vulnerable to that germ.
“Especially for sensitive populations, that quality control is so important. You don’t want contamination to rise to a level where it becomes a problem,” Dr. Amy Edwards, a pediatrician and associate medical director for infection control at UH Rainbow Babies & Children’s Hospital in Ohio, told ABC News. “That’s why inspections are meant to be incredibly invasive — we have to get close enough to zero contamination levels to be safe.”
Mead Johnson
In August 2021, FDA investigators made a routine visit to Mead Johnson’s plant in Evansville, Indiana, where it has operated for more than a century. An inspection report notifying the company’s management of objectionable conditions, called a Form 483, was issued, after investigators found the plant’s data wasn’t recorded frequently enough to ensure proper sterility of their product.
FDA investigators said that company records indicated Cronobacter was found in one of the plant’s rooms, and that the area was subsequently sanitized. A plant operator was observed not washing his hands between glove changes, and not changing his gloves between touching non-food and food contact surfaces.
The employee was subsequently retrained, Mead Johnson told the FDA, according to inspection documents. But it was not the first time investigators had flagged concerns at one of Mead Johnson’s plants.
In late 2017, seven investigators visited Mead Johnson’s plant in Zeeland, Michigan, after the company had alerted the FDA that two finished batches of Enfamil formula — batches that had already been exported from the country — tested positive for Cronobacter. An FDA inspection revealed that Cronobacter had been found “in critical and high hygiene areas of the processing environment on 26 occasions” between mid-January and late August of 2017, documents obtained by ABC News show.
FDA investigators also said they found Cronobacter specifically in areas that risked leading to “potential contamination” of “food contact surfaces.”
The potential problems the FDA discovered at the plant were addressed in time for later inspections — but food safety experts told ABC News these issues can become a serious problem if not immediately dealt with.
“Cronobacter is an environmental pathogen — it’s everywhere,” food safety attorney Bill Marler said. “But it’s really, really bad to have it in infant formula.”
Mead Johnson’s plant had “multiple wall leaks,” nonconformity reports reviewed by the FDA said, as well as “equipment condensation” in areas where positive Cronobacter samples were later found.
“Leaks are the bane of infection control,” Edwards said. “Water is life; if you’re not controlling your water, then you are not controlling your bacteria.”
The Zeeland facility submitted a corrective action plan, promising “increased frequency of cleaning the areas where positive results were identified, evaluation and inspection of equipment” and “repairs to equipment and the facility as needed.”
FDA investigators followed up with the Zeeland plant in spring 2018. The facility had retooled its sanitization procedures, implemented dryer inspections, and made repairs to flooring, water infiltration, and caulking.
Returning in March 2019, investigators noted the plant’s environmental monitoring program had identified and mitigated several instances of Cronobacter in various areas of the plant.
In a statement to ABC News, Reckitt, of which Mead Johnson is a division, maintained that the company manufactures their formula “using the highest standards for quality and safety,” adding that whenever the FDA finds an issue they “immediately develop and implement an action plan to address the issue.”
Reckitt said they “regularly review and enhance” their facilities’ manufacturing processes “and invest in new technologies and equipment,” adding that their “robust operating protocols meet or exceed the highest regulatory standards,” which they employed while “safely” increasing infant formula amid the shortage.
An FDA spokesperson, when asked for comment regarding their investigators’ findings of Cronobacter at multiple formula companies’ facilities, said the agency “takes its responsibility seriously” to ensure the rigorous safety of American foods, and that the agency is reexamining whether more can be done.
Based on a “close look at recent and historical findings” from inspections, the FDA spokesperson said, “We will be looking at what additional strategies could be employed to better prevent microbial contamination during the production of powdered infant formula,” adding the agency is “conducting an evaluation” of their response to the formula crisis “to determine what additional steps should be taken to ensure the maximum effectiveness of agency programs and policies related to infant formula and medical food.”
Nevertheless, said the spokesperson, “It is important to note that it’s a firm’s responsibility to ensure the consistent quality and safety of the products they produce.”
“We are most interested in how aggressively a firm addresses and responds to potential contamination,” the FDA spokesperson said.
Steven Lynn, the former director of the FDA’s pharmaceutical Office of Manufacturing and Product Quality, told ABC News that manufacturers’ oversight “must be robust to assure no adulterated product reaches the vulnerable infant population they serve.”
“It sounds easy, but it’s not,” said Lynn, an expert on good manufacturing practices. “Problems can and do occur. That’s a fact of life.”
Lynn, who reviewed the inspection documents obtained by ABC News, noted that there appear to be “problematic similarities” among some of the formula manufacturers’ lapses in quality control, including “issues with inadequate process controls, including cleaning, sampling and ultimately controlling the production environment to assure there is no microbial contamination,” he said.
Lynn said that FDA investigators did what they were supposed to do: identify deficiencies for the companies to fix.
“The key is making sure the issues are thoroughly investigated, and then implementing robust solutions to correct and prevent them from reoccurring in the future,” in order to ensure that “safe formula is on the market,” Lynn said.
Gerber
In August 2021, FDA investigators made a routine visit to Nestlé Nutrition’s Gateway facility in Eau Claire, Wisconsin, which makes Gerber products. They found “dirty scoops used during the previous production day” lying on a stainless steel table in one of the raw material rooms, and “debris” on the floor.
It was determined that some cleaning activities were resulting in water getting “trapped in cracks in the floor” and “onto equipment located on lower decks.”
In addition, Cronobacter was detected in an in-process powder sample of infant formula.
The finished lot of that product was immediately destroyed.
FDA investigators discussed their findings and suggested remedies with management, but did not issue a Form 483 at that time, according to inspection documents reviewed by ABC News.
A Gerber spokesperson told ABC News that their infant formulas go through up to 500 quality and safety checks, “many of which are above and beyond regulatory requirements.”
“If we find Cronobactor or any other contaminant in the product, that is when we take the most extreme reaction,” Scott Fitz, Vice President of Technical & Production for Gerber told ABC News.
“All the product in that batch is blocked, and all the batches around that product are blocked,” he said, adding that the company thoroughly investigates the contaminant’s origins and destroys any impacted product.
“Given the sensitive consumer we’re dealing with, we can’t take the chance of it getting to shelf,” Fitz said. “This isn’t about regulation, it’s about doing what’s right.”
PBM Nutritionals
After a routine visit in August 2019, the FDA issued a Form 483 identifying a cold storage temperature regulation deficiency at the Milton, Vermont, plant of PBM Nutritionals, a subsidiary of Perrigo, which makes store-brand formulas for retailers like Walmart and Amazon.
Investigators found that some of the facility’s data was not specific enough “to ensure there is no significant growth of microorganisms of public health significance” in their storage tanks. Documents provided by the company to the FDA noted a recent roof leak had overwhelmed the drainage system, and that, upon inspection, environmental sample swabs tested positive for Cronobacter before additional cleaning.
In a statement to ABC News, Perrigo said they are “proud” of their compliance track record, adding that the Cronobacter within the plant had been found by their own self-monitoring, rather than by FDA investigators.
“Our facilities in Vermont and Ohio are in good regulatory standing and remain compliant with all FDA processes and procedures,” they said.
Perrigo said they had hired independent experts “a few years ago” to “enhance” their manufacturing processes and protective measures. The company said the experts found their “aging equipment could lead to concerns in the future,” so they invested approximately $110 million in improving formula plant quality, and hired an additional 100 quality and sanitation personnel.
Perrigo said that they had addressed the FDA’s observation regarding cold storage.
“Our quality control process is a continuous improvement process, and any concerns found are promptly addressed,” the company said.
“Everybody knows what the persistent problems are that cause bacterial contamination in product,” said Marler, the food safety attorney. “It’s cracks, water, old equipment. It’s when companies stop realizing they’re producing food that is going into the bodies of babies and they start thinking about it as a widget, as a commodity.”
Patrick Stone, a former FDA investigator, says factories that make infant formula should be held to a higher quality-control standard than other mass market food products. But too often, he said, “it actually takes an outbreak or something to happen before people wake up and say …. ‘Why is this happening?'”
Abbott Nutrition
After inspecting Abbott’s Sturgis facility earlier this year, FDA chief Dr. Robert Califf described the “shocking” and “egregiously unsanitary conditions” investigators had found.
“Standing water; cracks in the key equipment that present the potential for bacterial contamination to persist, particularly in the presence of moisture; leaks on the roof; a previous citation for inadequate hand washing,” Califf testified before Congress in May. “Many signs of a disappointing lack of attention to the culture of safety, in this product that is so essential to the lives of our most precious people.”
Investigators discovered five strains of Cronobacter from environmental sampling of Abbott’s plant, and Abbott ultimately agreed to shutter the facility and recall the formula.
Food safety experts ABC spoke with emphasized the importance of establishing — and adhering to — a proactive protocol for rooting out risk factors, before they snowball.
“You don’t wait for the accident to happen before you build a stoplight,” said Faber, the food safety expert. “You probe your factory for where pathogens could be lurking, and then adopt critical controls to eradicate them.
“If we’re seeing any of the conditions found at Sturgis in other plants, we need to ask whether that philosophy has been sufficiently embraced,” he said.
“Abbott has a zero-tolerance policy for Cronobacter in our plants, which is why we took the steps we did at Sturgis,” an Abbott spokesperson said. “Our highest priority is getting babies safe, quality formula they need.”
Further complicating the matter is that Cronobacter infection is listed as a reportable illness by only one U.S. state: Minnesota, where the first of the four infants was reported infected after consuming Abbott’s formula last September.
Because there are no national requirements that Cronobacter be reported, doctors and labs are not required to report cases to their local health department — which leaves the FDA to rely on consumer complaints and health care providers for on-the-ground data regarding infections.
“Until you increase that oversight, you’re going to limp from mini-outbreak to mini-outbreak,” Marler said.
A ‘stringent enough’ system?
In August 2017, a few months before the FDA found Cronobacter inside Mead Johnson’s Zeeland plant, a two-week old infant from Illinois was declared brain dead after being diagnosed with a Cronobacter infection. The infant had consumed “multiple lots of Enfamil Newborn Premium ready-to-feed liquid milk product at the hospital, and some product was sent home with the parents,” FDA inspection reports say.
But FDA sampling of the available formula was negative for Cronobacter.
Reckitt told ABC News they “cooperate fully with the FDA to investigate consumer complaints,” underscoring that their formula had never conclusively been proven as the cause of an illness.
In the case of Abbott, too, no conclusive causation has been proven between the Cronobacter found at the Sturgis plant and infants’ illness or death. Nevertheless, FDA chief Califf noted in congressional testimony that “we cannot rule it out either, as the confluence of events is highly unusual. There is no dispute that the facility was unacceptably unsanitary.”
“There is some room for human error, but not for persistent human error,” said Edwards. the pediatrician. “You have to have your process in place. And you have to have a process for monitoring your process to make sure it’s always being followed.”
When several controls fail at once, it risks prompting an unfortunate domino effect and “raises important questions about whether our current regulatory system is stringent enough,” Faber said.
The FDA spokesperson told ABC News that the agency is assessing whether their annual surveillance inspections of formula facilities should include more environmental sampling going forward, albeit in a way that “minimizes any disruptions to the supply chain.”
In June, ABC News was first to report that the Health and Human Services’ Office of Inspector General had launched an audit into how the FDA responded leading up to the recall and closure of Abbott’s Sturgis plant.
The CDC says Cronobacter infections are rare, but serious in infants — noting that powdered formula can be contaminated at a processing facility, or at home. Because Cronobacter can survive so well — on kitchen counters, on sinks, or in a manufacturing plant — the CDC recommends that families using formula wash hands frequently around infants, thoroughly clean bottles, and safely store any powdered formula, or, if possible, use liquid formula.
“There are babies out there whose lives depend on formula. So what happens when the thing that you’re giving your baby is actually the thing that makes them sick?” Edwards said. “That is incredibly scary. For parents, for all of us.”
ABC News’ Eric M. Strauss contributed to this report.
(NEW YORK) — As the federal government aims at expanding protections for LGBTQ people, Florida Gov. Ron DeSantis and state agencies are vowing to dodge those safeguards.
In a memo from the Florida education department on Thursday, the agency told state schools to ignore nondiscrimination guidance from the U.S. Department of Education and Department of Agriculture.
The federal guidance stated that schools cannot discriminate on the basis of sexual orientation and gender identity under Title IX, as the definition of “sex” includes such categories.
Several federal agencies have issued similar guidance.
DeSantis’ office expressed its support in the education department’s memo in a statement to ABC News.
“The governor’s office fully supports the Florida Department of Education in its position on these proposed rule changes and stands with Commissioner Diaz in refusing to allow the federal government and the Florida Commissioner of Agriculture to hold vulnerable students hostage to their political agenda,” said the governor’s office.
The news comes as Florida’s Agency for Healthcare Administration proposed a ban on Medicaid coverage for puberty blockers, hormones, sex reassignment surgeries, and “any other procedures that alter primary or secondary sexual characteristics.”
The AHCA is debating whether gender-affirming care falls under the “Generally Accepted Professional Medical Standards” for trans Medicaid recipients.
Simultaneously, the state’s health department has asked the Florida Board of Medicine to restrict transition-related care for transgender minors, a letter obtained by NBC News read.
The federal government is trying to fight such restrictions. The U.S. Department of Health and Human Services recently proposed a rule that prohibits discrimination on the basis of race, color, national origin, sex, age, and disability in certain health programs and activities.
Health experts and activists applauded the move, as it includes protections for LGBTQ identities.
“What we’re seeing happening in the states right now is an attempt to codify discriminatory attitudes towards LGBTQ people, particularly transgender people, in state law,” Kellan Baker, the executive director of the LGBTQ health advocacy group Whitman-Walker Institute, told ABC News.
“There’s nothing unusual about health care for transgender people. They all came from procedures, interventions, medications, and services that had been provided to cisgender people for a long time,” he added.
Research has shown that gender-affirming care can be life-saving for transgender people, and will improve the physical and mental health of those who receive it.
These ongoing battles come amid a growing list of instances in which DeSantis continues to spark debate against LGBTQ identities. Just a few weeks earlier, the Parental Rights in Education law, dubbed the “Don’t Say Gay” law, went into effect.
It bans classroom instruction on “sexual orientation or gender identity may not occur in kindergarten through grade 3 or in a manner that is not age-appropriate or developmentally appropriate for students in accordance with state standards,” according to the law’s language.
DeSantis and supporters of the law say it will give families more input in what their children are learning in schools and that children should not be learning about gender identity and sexual orientation at a young age.
Critics of the law said they believe it would set back the progress made by the LGBTQ community in the last few decades, and make children feel as though LGBTQ identities should be silenced or not spoken about. They say topics involving gender identity and sexual orientation are not inherently sexual, inappropriate or shameful.
More than 6 in 10 Americans oppose legislation that would prohibit classroom lessons about sexual orientation or gender identity in elementary school, a recent ABC News/Ipsos poll found.
Instances of vandalism and threats against gay bars, drag shows and drag queen story hours continue to be reported, with activists blaming anti-LGBTQ legislation and political rhetoric.
(NEW YORK) — New York Gov. Kathy Hochul issued an executive order Friday in response to the growing monekypox outbreak in the state and declared it to be a “disaster emergency.”
“After reviewing the latest data on the monkeypox outbreak in New York State, I am declaring a State Disaster Emergency to strengthen our aggressive ongoing efforts to confront this outbreak,” Gov. Hochul said. “More than one in four monkeypox cases in this country are in New York State, and we need to utilize every tool in our arsenal as we respond. It’s especially important to recognize the ways in which this outbreak is currently having a disproportionate impact on certain at-risk groups. That’s why my team and I are working around the clock to secure more vaccines, expand testing capacity and responsibly educate the public on how to stay safe during this outbreak.”
According to data by the Centers Centers for Disease Control and Prevention, New York has the highest reported cases of monkeypox.
There have been 1383 reported cases of monkeypox in New York, according to state data and almost 5,000 in the U.S., according to the Centers for Disease Control and Prevention, and the executive order will allow the state to respond more quickly to the monkeypox outbreak and enable health care workers to help get more New Yorkers vaccinated.
Hochul’s declaration came a day after monkeypox was considered an “imminent threat” to the public health by New York state’s health commissioner, Dr. Mary Bassett.
Commissioner Barrett said in a statement that the designation meant that “local health departments engaged in response and prevention activities will be able to access additional State reimbursement, after other Federal and State funding sources are maximized.”
Monkeypox is primarily spread from person to person contact through close and physical contact. A fever, muscle ache, chills, headache and fatigue are some of the symptoms. Sores and painful rashes also develop on a person’s body.
Most cases in the U.S. have been reported among the gay, bisexual and other men who have sex with men community and related to male-to-male sexual contact. Though health officials have repeatedly stressed that the virus can affect anyone who has close contact with people who have monkeypox. Those with weakened immune systems, pregnant people and children under the age of 8 may be at heightened risk for severe outcomes, according to the CDC.
“Every American should pay attention on monkeypox,” Health and Human Services Secretary Xavier Becerra told reporters Thursday. “Monkeypox is not COVID, but it is contagious. It is painful and can be dangerous.”
The World Health Organization declared the monkeypox outbreak a public health emergency of international concern last week.
ABC News’ Matt J. Foster and Meredith Deliso contributed to this report.
(WASHINGTON) — Democratic Rep. Dean Phillips, D-Minn, said publicly that he would not support President Joe Biden in 2024 amid a slew of new polling reflecting Democrats’ desire for a new presidential candidate.
The White House on Friday dodged probing by ABC News’ Molly Nagle into what the administration thought about the House Democrat’s comments.
“Look, I’m going to stay where I am,” White House press secretary Karine Jean-Pierre told ABC News. “The President intends to run in 2024. We are ways away from 2024. We are going to continue to focus on doing the business of the American people by delivering for families by lowering costs for families.”
Phillips on Friday called for a “new generation” of leadership on Friday in the White House in an interview on the Twin Cities-based radio show WCCO-AM.
“I think the country would be well-served by a new generation of compelling, well-prepared, dynamic Democrats who step up,” Phillips said.
“I think it’s time for a generational change,” said Phillips, who told host Chad Hartman he expects more Democrats to start speaking out about their concerns. “And I think most of my colleagues agree with that.”
President Biden is experiencing heightened levels of doubt from inside his own party, with a New York Times/Siena College poll earlier this month showing 64% of Democratic voters saying they would prefer a new standard-bearer for a White House bid in 2024. His job-approval rating remains at 33%, according to the same poll.
“I have respect for Joe Biden, I think he has — despite some mistakes and some missteps, despite his age — I think he’s a man of decency, of good principle, of compassion, of empathy and of strength,” Phillips added.
Biden and other White House officials have attempted to defend his electability in recent weeks, however.
Biden fired back in early July at ABC News reporter Ben Gittleson, who asked about Democrats who’d prefer he didn’t run again.
“Read the poll,” Biden said, referring to the NYT/Siena College poll. “92% said if I did [run again], they’d vote for me.”
Jean-Pierre also cited the 92% figure when asked to react to the poll– which, administration supporters were also quick to note, did show him winning a hypothetical rematch with former President Donald Trump.
“You know, there’s going to be many polls,” she said. “They are going to go up and they are going to go down. This is not the thing that we are solely focused on.”
Polling data also shows that a majority of Americans would not prefer the former president seek another White House term either.
Trump has teased, but has not officially confirmed a plan to run for another White House term, while Biden has said multiple times that he will seek reelection.
“When you have such a sour, negative political environment, voters in general are looking for change,” GOP pollster Robert Blizzard told ABC News earlier this week. “They’re looking for new voices, new people.”
(DECATUR, Ga.) — The family of a Georgia woman who died after she was taken into custody and fell out of a moving police patrol car earlier this month is demanding answers in her death.
Brianna Grier, 28, was taken into custody on July 15 after two Hancock County Sheriff’s Office responded to her home in Sparta, Georgia, authorities said.
Her mother had called 911 because her daughter was having a mental health crisis, according to civil rights attorney Ben Crump, who is representing the family.
While being transported to the sheriff’s office, Grier fell out of a patrol car and sustained “significant injuries,” the Georgia Bureau of Investigation (GBI), which is investigating the death, said in a statement.
Grier suffered brain trauma and was in a coma before she died on July 21, according to Crump.
“Yet again, we have another African American citizen killed in just an unbelievable way while in the custody of the police,” Crump said during a press briefing Friday.
The briefing comes two days after GBI released new details in the incident.
According to GBI, Grier was placed in the backseat of the patrol car while handcuffed with no seatbelt on. The rear passenger side door was never closed before they drove away, GBI said.
Before the deputies placed her in the car, Gier was on the ground “refusing to get in the patrol car” and “made a statement that she was going to harm herself,” GBI said.
Both the rear driver’s side door and rear passenger side door were open while the deputies put Grier in the backseat, but they only closed the rear driver’s side door before leaving the scene and driving a short distance, GBI said.
“The investigation shows that the deputy thought he closed the rear passenger side door,” GBI said. “Body camera footage reveals the deputies had no other contact with Grier from the time she was placed in the car until she fell out of the moving car.”
The family is calling for more transparency as they try to make sense of what happened, including the release of the body-camera footage.
“We’re trying to get answers of what really happened, that’s all we want to know,” Grier’s father, Marvin Grier, said during Friday’s press event. “We want to know what happened.”
“That was my child,” he continued. “That was my child.”
The incident is still under investigation by GBI.
Hancock County Sheriff Terrell Primus told protesters gathered outside the sheriff’s office on Wednesday that he plans to release body-camera footage of the incident once GBI’s investigation is completed, the Union-Recorder reported.
“A lot of people have already drawn their own conclusions,” he said, according to the publication. “Some people already feel as though we have things to hide. But we do not have anything to hide. The video footage will show evidence based on what has been stated already.”
Crump said his team plans to perform an independent autopsy once her body is released from GBI, and that they will investigate what led to Grier, a mother of 3-year-old twin daughters, falling out of the car while it was moving.
“That’s what we are primarily for — is to get answers and demand justice,” Crump said. “What this is really about is those 3-year-old little babies [who are] going to have to grow up without their mother.”
Gerald Griggs, president of the Georgia State Conference of the NAACP, joined the family on Friday and called for accountability.
“To the Hancock County sheriff, it’s time to be transparent. It’s time to be accountable,” he said. “To the GBI, it’s time for y’all to meet with this family. To the governor, it’s time for you to recognize, again, that Georgia has a police accountability problem.”
“Georgians of all color deserve to feel protected in the custody and control of law enforcement,” he said.