Former New York Gov. Andrew Cuomo set to testify on COVID-19 nursing home policies
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(WASHINGTON) — Former New York Gov. Andrew Cuomo is set to publicly testify Tuesday before Congress on his administration’s nursing home policies during the early days of the COVID-19 pandemic.
The hearing, before the Republican-led House Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic, will see Cuomo defend his decision to allow COVID-19-positive patients back into nursing homes and long-term care facilities while the pandemic was underway.
Cuomo previously testified before the subcommittee during a closed-door hearing in June. Transcripts from that interview, as well as with high-ranking officials during Cuomo’s administration, will be released ahead of the public hearing.
“Andrew Cuomo owes answers to the 15,000 families who lost loved ones in New York’s nursing homes during the COVID-19 pandemic,” subcommittee Chairman Rep. Brad Wenstrup, R-Ohio, said in a statement last week. “On September 10, Americans will have the opportunity to hear directly from the former governor about New York’s potentially fatal nursing home policies.”
In March 2020, as COVID-19 cases were surging, Cuomo issued an order requiring nursing homes to readmit all residents who were “medically stable” and returning after being hospitalized for the virus.
“No resident shall be denied re-admission or admission to the [nursing home] solely based on a confirmed or suspected diagnosis of COVID-19,” the order read.
It further stated that nursing homes were “prohibited from requiring a hospitalized resident who is determined medically stable to be tested for COVID-19 prior to admission or readmission.”
At the time, Cuomo explained that the order would help expand hospital capacity to meet the demands of caring for the sickest COVID-19 patients. After facing criticism from nursing home advocates, however, the governor amended the order in May 2020, prohibiting hospitals from discharging patients to nursing homes unless they first tested negative for COVID-19.
Cuomo fought back against criticism of his policies and, in July 2020, a report from the New York State Department of Health (NYSDOH) stated that COVID-19 was introduced into nursing homes by infected staff, and that peak staff infections correlated with peak nursing home resident deaths. The report also found that “admissions policies were not a significant factor in nursing home fatalities.”
However, in January 2021, New York Attorney General Letitia James released a report that found the NYSDOH had undercounted the number of nursing home residents who died of COVID-19 by as much as 50%, and failed to count in its official death tally nursing home residents who died of COVID-19 after being admitted to hospitals.
In 2022, Cuomo’s representative said the Manhattan District Attorney’s office would not file criminal charges in connection with the former governor’s handling of nursing home deaths during the pandemic.
Earlier this year, an independent investigation, commissioned by current New York Gov. Kathy Hochul, found that although Cuomo’s nursing home response policy was based on “the best available data at the time,” communication to the public was poor and caused anxiety for family members of nursing home residents.
“Even the most well-intentioned policy had unforeseen consequences in [New York state] nursing homes,” the report read.
(YEMASSEE, SC) — With four primates still on the loose after 43 of them escaped on Nov. 6 from the Alpha Genesis Inc. research laboratory in South Carolina, the Low Country facility has come under intense scrutiny.
Animal rights groups have cited the company’s history of violations and previous monkey breakouts; a member of Congress has called for an inquiry into its oversight by multiple federal agencies; and residents voiced concern the furry fugitives might spread disease throughout their community.
On top of it all, Alpha Genesis founder and CEO Gregory Westergaard told ABC News his company is investigating whether the release of the monkeys was “an intentional act” by an employee.
The quest for freedom by the pack of young female rhesus macaques coincides with the rapid expansion of the 100-acre Alpha Genesis facility and is casting light on a disruption in the U.S. medical research industry that sounds like a plot for a science fiction thriller. A 2023 report sponsored by the National Institutes of Health warned of a crisis involving the Chinese government that “undermines the security of the nation’s biomedical research enterprise.”
The case of the absconding primates has also raised questions about why the amount of federal contracts received by the testing and breeding operation has jumped more than 160% since 2021. According to USASpending.gov, a government website that tracks federal spending, the company has been granted $19 million in federal contracts this year alone.
“It’s shocking how much money is being spent on testing primates,” Rep. Nancy Mace, R-S.C., told ABC News.
Mace’s district encompasses the Beaufort County community of Yemassee, where the 6,701 primates housed at the sprawling Alpha Genesis facility nearly triple the number of town residents.
In a formal letter to the NIH, the agency that funds laboratory research, and the U.S. Department of Agriculture, which inspects and regulates breeding facilities, Mace expressed “very urgent concerns regarding federal oversight of Alpha Genesis.” Mace said the prolonged attempts to recapture all of the primates are “placing the animals and my constituents at risk.”
“A lot of constituents were concerned about whether or not the primates that escaped were sick or ill, or have been tested on,” Mace told ABC News. “There were a lot of folks concerned about the facility being a breeding facility and the testing that goes on there as well.”
The escape highlights an ‘issue of national security’
The incident some locals have referred to as “the great escape” has illuminated the international crisis hitting the animal research industry that Alpha Genesis’ Westergaard said has become “an issue of national security.”
In 2020, the Chinese government, the world’s primary breeder of research monkeys, banned the exports of nonhuman primates (NPH) to labs in the United States and elsewhere, triggering an international shortage of the animals just as research scientists were scrambling to come up with vaccines to combat the COVID-19 pandemic, according to a May 2023 report by National Academy of Engineering and National Academy of Medicine.
Primates, according to the NIH-supported report, are valuable in answering certain research questions because of their genetic, anatomic, physiologic and behavioral similarities to humans. However, the China ban on exporting research animals exacerbated the shortage and stalled NIH-funded research, according to the report.
The report concluded that the United States “needs to prioritize expansion” of domestic primate breeding programs.
“Relying on importing these animals from other countries is unsustainable, and dependence on international sources undermines the security of the nation’s biomedical research enterprise,” the report warned.
In 2021, the National Primate Research Centers could not meet two-thirds of researcher requests for rhesus macaques, according to the report.
“Researchers also face increased wait times for animals, and costs have risen 10% to 200% for a single animal, depending on the species,” the report said.
What we know about Alpha Genesis’ research
The crisis prompted Alpha Genesis to increase its domestic breeding of research primates. According to Rep. Mace, the company also manages the NIH’s so-called “Monkey Island” on Morgan Island in Beaufort County, which holds another 3,300 primates.
Westergaard told ABC News that Alpha Genesis employs 275 people, plus 30 or so contractors.
In addition to breeding lab monkeys, Alpha Genesis provides researchers across the country with biological products and materials, including serum, plasma, whole blood and tissue samples from a wide variety of research species, according to the company’s website. The private company’s researchers have helped develop several therapeutic drugs and vaccines, including those to treat the COVID-19 virus.
According to NIH online records provided to USASpending.gov, the crisis appears to be in accord with a boost in federal contracts Alpha Genesis has received, jumping from $7.3 million in 2021 to $12.3 million in 2022, $14.2 million in 2023 and $19 million this year.
Primates are worth up to $30,000 each
“The price of research monkeys has indeed increased a great deal since the Chinese banned all exports,” Westergaard said in an email to ABC News. “Prior to the ban monkeys sold for around $4K – $6K, after the ban prices have increased to $10K – $30K+ due to increased costs of raising animals in the US compared to China. An important point to note is that the shortage remains severe and a great deal of research in the US simply cannot be done because animals are not available at any cost.”
Westergaard said some suppliers of laboratory primates have turned to the illegal sourcing of wild-caught monkeys from Cambodia, “which we have not done.”
“It should also be noted that the Chinese government is seeking worldwide domination in medical research and the development of bio-weapons to target US citizens and our allies,” Westergaard said.
He added, “Alpha Genesis is a leading provider of NHPs to the US market and has been instrumental in attempting to fill this void. The alternative is to allow the Chinese to dominate medical development to the severe detriment of our National Security interests.”
“It should also be noted that the Chinese government is seeking worldwide domination in medical research and the development of bio-weapons to target US citizens and our allies,” Westergaard said.
He added, “Alpha Genesis is a leading provider of NHPs to the US market and has been instrumental in attempting to fill this void. The alternative is to allow the Chinese to dominate medical development to the severe detriment of our National Security interests.”
Human error or intentional act?
Asked by ABC News whether the rapid expansion of Alpha Genesis’ breeding and testing operations might have played a role in the escape of the 43 primates, Westergaard said the cause of the escape remains under investigation, including whether it was the result of “human error” or an “intentional act.”
“All the information we have thus far indicates that this is human error due to an employee failing to secure containment doors behind her, and a third door directly containing the animals, while doing routine cleaning and feeding,” Westergaard said in an email. “The enclosure was brand new and in perfect working order. We continue to investigate in an attempt to determine to the greatest extent possible whether this was or was not an intentional act.”
Westergaard said that immediately after the incident occurred, the employee’s supervisor told her she could be fired if it was determined that no structural failure of the primates’ enclosure led to the incident. Westergaard said the employee walked off the job and has not returned.
As of early Tuesday, four of the escaped primates remained on the loose, Westergaard said. Two were caught Monday, he said.
“The girls from today are in good health and the others continue to thrive,” Westergaard said Monday. “We believe the four monkeys remaining are probably all together either in the area adjacent to our property or somewhere else very close by.”
Mace has requested answers from NIH Director Monica Bertagnolli, USDA Deputy Administrator for Animal Care Sarah Helming, and Acting Director Axel Wolf of the NIH’s Office of Laboratory Animal Welfare. She also noted that this was not the first time problems had arisen at the research lab.
Mace, who told ABC News she is against animal testing, cited in her letter a September 2022 USDA inspection report of Alpha Genesis that found six separate incidents of animals escaping from their primary enclosures between January and August of 2022. Mace also cited escapes dating back to 2014, when more than two dozen monkeys slipped out of the facility, resulting in a fine from the USDA.
The 2022 USDA inspection report, which ABC News reviewed, also found an infant monkey died after becoming entangled in a stretch of gauze material used in an enclosure to hold a water bottle; said two primates were found dead in their enclosures with their fingers entrapped in structures inside their cages; and documented that one animal died from trauma and four others required veterinary care after they were placed in incorrect enclosures and were attacked by other primates unfamiliar with them.
As a result of the inspection, Alpha Genesis, according to the report, took corrective action to secure enclosures and “made significant changes” to avoid putting primates in the wrong enclosures.
The latest USDA routine inspection of Alpha Genesis lab was conducted on May 21 and concluded, “No non-compliant items identified during this inspection,” according to USDA online records.
“This is also true of several other inspections in recent years,” Westergaard said. “For a facility of this size that is quite remarkable.”
Mace said she met with Westergaard last week to discuss the escape and what Alpha Genesis is doing to round up the monkeys.
“It was an interesting conversation,” Mace said. “He tried to tell me how good the primates have it at his facility. And my response was, they have it good until you kill them with disease.”
Asked about the conversation, Westergaard responded: “I spoke to the congresswoman last week and at that time she said that she recognized the economic importance of our company to the people of the Low Country and that as a locally-owned business, she would continue to offer her full support.”
Alternatives to testing primates
Angela Grimes, CEO of Born Free USA, an international wildlife conservation and animal protection organization, told ABC News that her group has sent a letter to Alpha Genesis offering to rehome the escaped primates to its animal sanctuary in South Texas, where more than 200 rhesus macaque monkeys now reside, including some rescued from U.S. research labs. She said an anonymous donor has pledged $250,000 to help move the animals to the sanctuary.
“What we’d like to see is these animals be released to the Born Free USA sanctuary in South Texas, where they can have some of that freedom that they’ve just gotten a taste of,” Grimes said.
Grimes said Alpha Genesis has not responded to her group’s offer.
The nonprofit Born Free USA Primate Sanctuary, a 175-acre facility in Dilley, Texas, has been accredited since 2009 by the Global Federation of Animal Sanctuaries, GFAS executive director Valerie Taylor told ABC News, adding that her group conducts rigorous assessments and inspections of animal sanctuaries across the United States and around the globe to ensure the highest standard of animal care possible. Taylor said U.S. animal sanctuaries undergo accreditation every three years and that her organization recently visited the Born Free USA sanctuary as part of the reaccreditation process.
“We meet and exceed GFAS’ highest standards,” Grimes said.
Grimes said the medical research industry needs to research alternatives to subjecting primates to experimental testing of deadly diseases.
“I understand human health is important, but I also look at the other viable alternatives that are out there that do not result in the suffering and death of animals,” Grimes said.
Westergaard said testing of primates is necessary, though.
“There is no safe or effective way to make the leap from simpler model organisms like mice and rats to humans without using NHPs as an intermediary,” Westergaard said. “The therapeutics created using NHPs as research models directly lead to lifesaving and life-prolonging treatments and cures for human disease. Without NHPs as a research model, the world would still be ravaged with wide-spread polio, smallpox wouldn’t be eradicated, and HIV would still be a death sentence.”
(SILVER SPRING, Md.) — The U.S. Food and Drug Administration (FDA) on Thursday approved the first new drug to treat people with schizophrenia in more than 30 years.
Cobenfy, manufactured by Bristol Myers Squibb, combines two drugs, xanomeline and trospium chloride, and is taken as a twice-daily pill. In clinical trials, this combination helped manage symptoms such as hallucinations, delusions, and disorganized thinking, which are common in schizophrenia.
“Schizophrenia is a leading cause of disability worldwide. It is a severe, chronic mental illness that is often damaging to a person’s quality of life,” Tiffany Farchione, M.D., director of the Division of Psychiatry, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in the approval announcement.
“This drug takes the first new approach to schizophrenia treatment in decades,” Farchione continued. “This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed.”
Cobenfy offers new hope for people with schizophrenia, providing an innovative treatment option that could change how this condition is managed, according to Jelena Kunovac, MD, a board-certified psychiatrist and adjunct assistant professor at the University of Nevada, Las Vegas, in the Department of Psychiatry.
“We are overdue for a medication that targets schizophrenia with a different mechanism of action,” Kunovac told ABC News.
The first drugs for schizophrenia, including chlorpromazine and haloperidol – also known by the brand names Thorazine and Haldol, respectively – were introduced in the 1950s and revolutionized treatment of the disease. However, there have been very few new medications since then, with most subsequent FDA approvals being for variations of these older drugs.
Most schizophrenia medications, broadly known as antipsychotics, work by changing dopamine levels, a brain chemical that affects mood, motivation, and thinking, Kunovac explained. Cobenfy takes a different approach by adjusting acetylcholine, another brain chemical that aids memory, learning and attention, she said.
By focusing on acetylcholine instead of dopamine, Cobenfy may reduce schizophrenia symptoms while avoiding common side effects like weight gain, drowsiness and movement disorders, clinical trials suggest. These side effects often become so severe and unpleasant that, in some studies mirroring real-world challenges, many patients stopped treatment within 18 months of starting it.
In clinical trials, only 6% of patients stopped taking Cobenfy due to side effects, noted Dr. Samit Hirawat, chief medical officer at Bristol Myers Squibb. “That’s a significant improvement over the 20-30% seen with older antipsychotic drugs,” he added.
The most common side effects of Cobenfy are nausea, indigestion, constipation, vomiting, hypertension, abdominal pain, diarrhea, increased heart rate, dizziness and gastroesophageal reflux disease, according to the FDA announcement.
“It may prove advantageous to those who don’t tolerate what has been available,” Dr. Leslie Citrome, a clinical professor of psychiatry and expert in psychopharmacology at New York Medical College, told ABC News regarding Cobenfy. “This will provide a new approach that may work out quite nicely.”
Citrome emphasized that patients who have trouble tolerating the side effects of traditional schizophrenia medications may benefit most from Cobenfy, and that a different mechanism of action holds hope for those who have not responded adequately to existing treatments.
Schizophrenia is a mental health disorder that affects about 24 million people worldwide, or roughly one in 300 people, according to the World Health Organization (WHO). It often leads to significant challenges in daily functioning, work, and relationships, impacting both patients and their families.
The disorder typically begins in late adolescence or early adulthood and can lead to lifelong disability if not properly managed, according to the WHO, further highlighting the need for effective treatment options.
Following approval, doctors could start prescribing Cobenfy by the end of October, according to Adam Lenkowsky, executive vice president and chief commercialization officer at Bristol Myers Squibb.
Experts hope that the drug’s unique mechanism and reduced side effects will help set a new standard of care for schizophrenia patients. Studies for additional therapeutic uses, including the treatment of Alzheimer’s disease and bipolar disorder, are also underway.
Jake Goodman, MD, MBA is a psychiatry resident physician and a member of the ABC News Medical Unit.
(LOS ANGELES) — While Los Angeles County is reporting three locally acquired cases of dengue this year — which is rare for the region — there have been at least 3,085 cases nationally of locally acquired virus so far this year, according to data from the Centers for Disease Control and Prevention.
There has been about double the number of locally acquired dengue cases so far this year nationally compared to last year, according to the CDC. Puerto Rico currently makes up the bulk of those cases – with over 2,960 reported. The U.S. territory declared a public health emergency back in March.
“The City of Baldwin Park is aware of the recent cases of locally acquired dengue in our community. While the risk of transmission remains low, we must take this situation seriously and act proactively,” said Mayor Emmanuel J. Estrada.
Dengue viruses spread through mosquito bites. The most common symptom is a fever with aches and pains, nausea, vomiting and rash. Symptoms usually begin within two weeks after being bitten by an infected mosquito and last 2-7 days. Most people recover after about a week.
Locally acquired cases mean that the people infected have no history of traveling to an area where dengue normally spreads. Local dengue transmission is typically common in tropical and subtropical areas of the world – including Florida, and U.S. territories in the Caribbean.
Last year, there were only two locally acquired cases reported in the state of California, the first local cases in the state reported in over a decade, according to CDC data.
The CDC issued a health alert in June warning health care providers of an increased risk of dengue virus infection this year. Globally, new cases of dengue have been the highest on record, according to the CDC. The agency also noted that cases are likely to increase as global temperatures increase.
The best way to prevent dengue is to avoid mosquito bites, according to the CDC.
