FDA begins testing aged raw cow’s milk cheese samples nationwide for bird flu
Al Drago/CQ Roll Call
(NEW YORK) — Federal health officials have begun collecting samples of aged raw cow’s milk cheese across the U.S. to test for bird flu, the Food and Drug Administration announced.
Sample collection started at the end of this month and is expected to be completed by the end of March 2025, the FDA said Monday. If needed, the agency said it will extend the collection period.
It comes after the U.S. Department of Agriculture issued a federal order earlier this month that raw milk samples nationwide would be collected and shared with the agency to be tested for bird flu.
The FDA said it plans to collect 300 samples of raw cow’s milk cheese that has been aged for at least 60 days from warehouses and distribution centers across the country.
Samples will be tested with a PCR test, which looks for genetic material from the virus, and will be completed within one week of collection, according to the FDA. Samples that indicate the presence of the virus will undergo viability testing.
Viability testing will be done by injecting part of the virus into an embryonated egg and analyzing if it grows or multiplies.
Raw milk cheese is made with unpasteurized milk. In the U.S., cheese can be made from raw milk but must be aged a minimum of 60 days to lessen the risk of any pathogens that may be present, per the FDA.
Samples that test positive for viable virus will be “evaluated on a case-by-case basis,” the FDA said, and the agency may issue actions “such as a recall, follow-up inspection or other possible responses to protect public health.”
The FDA has previously warned of the dangers of drinking raw milk, which does not undergo pasteurization — a process that kills viruses and bacteria. The agency currently considers unpasteurized soft and hard cheeses, as well as other products made from unpasteurized milk, a “high-risk choice.”
Past studies from federal health officials have shown that pasteurization effectively kills the bird flu virus. Nearly all, or 99%, of the commercial milk supply produced on dairy farms in the U.S. follows a national pasteurization program.
Pasteurization has been a practice in the U.S. for more than 100 years and kills harmful bacteria and viruses by heating milk to a specific temperature over time, the FDA notes.
The U.S. has been facing an outbreak of bird flu, or avian influenza, since April, when the first human case was reported.
Almost all confirmed cases have had direct contact with infected cattle or infected livestock. Most bird flu cases in the U.S. have been mild, and patients have typically recovered after receiving antiviral medication.
Three influenza A (H5N1/bird flu) virus particles (rod-shaped). Note: Layout incorporates two CDC transmission electron micrographs that have been inverted, repositioned, and colorized by NIAID. Scale has been modified. Image via CDC and NIAID.
(NEW YORK) — As seasonal influenza ramps up, and with bird flu continuing to circulate, some public health experts are worried there may be a strain on the public health system.
Since the bird flu outbreak began earlier this year connected to dairy cows and poultry, there have been 55 human cases reported in the U.S., according to the Centers for Disease Control and Prevention (CDC). This includes a child in California, who was confirmed on Friday by the agency to be the first pediatric case linked to the outbreak.
There is currently no evidence of person-to-person transmission of bird flu and the risk to the general public is low, federal health officials say. But with millions of seasonal flu infections around the corner, there is some concern about additional stress on how public health surveillance systems will track the virus.
“I think it does add a layer of stress, at least in the public health planning part of things, because we have to think about what resources would be necessary were we to have a significant outbreak of bird flu,” Dr. Tony Moody, a professor of pediatrics and infectious diseases specialist at Duke University, told ABC News.
Bird flu and seasonal flu at the same time
Currently, respiratory virus activity is low in the U.S., but the country is on the brink of entering traditional flu season.
Dr. Otto Yang, a professor of medicine and microbiology, immunology and molecular genetics at the David Geffen School of Medicine at the University of California, Los Angeles, said the flu season earlier this year in the Southern Hemisphere looked typical so the same can be expected for the Northern Hemisphere.
Countries in the Southern Hemisphere experience their flu season before countries in the Northern Hemisphere. This often provides a glimpse as to what the upcoming flu season may potentially look like for the Northern Hemisphere, though it is not fully predictive of what may occur in each individual country.
“It looks like everything so far points to a fairly typical flu season in terms of the numbers, not [an] especially severe flu season, but not one especially mild either,” he told ABC News.
So far, all bird flu cases in humans in the U.S. have been mild and patients have all recovered after receiving antiviral medication. Almost all confirmed cases have had direct contact with infected livestock.
Yang said he doesn’t see bird flu putting a major strain on the health system right now, but there are unknown factors such as whether COVID-19 or RSV will lead to a higher number of cases than normal.
Moody added that health systems have conversations every year about respiratory virus season regarding whether there are enough beds, enough staff and enough equipment to treat sick patients, and that unknown factors always present a threat.
“That’s what we would be thinking about, is, what can we do to try to blunt that as much as possible, because it’s not so much that the public health system can’t absorb it,” he said. “They just can’t absorb everything all at once.”
Testing for bird flu
With flu season expected to start ramping up in the coming weeks, it may be increasingly difficult to differentiate bird flu from seasonal flu without more extensive testing, experts say.
“The reality is, we want to be ahead of a problem. There’s a surveillance challenge that was easier in the summer because we didn’t have seasonal flu cycling,” said Dr. John Brownstein, an epidemiologist and chief innovation officer at Boston Children’s Hospital and an ABC News medical contributor. “As we enter flu season, we’re going to have a respiratory mix that includes flu and may include cases of avian, and it’ll be an even greater needle in the haystack.”
Right now, a PCR test, which checks for genetic material, is needed to detect a novel flu virus in a patient. More than 60,000 tests have been completed by public health labs to detect any presence of bird flu since February of this year, according to the CDC.
Tests are sent to public health labs if there is suspicion of bird flu exposure from a clinician or a sample was submitted for surveillance purposes. Health care systems send in a quantity of flu samples to public health labs for additional testing to help detect any new bird flu cases, which is how a case in Missouri was initially identified.
“We’re doing some opportunistic sampling of cases that would get additional sequencing. [Our hospital] is sending five samples per week to state labs that would ultimately get deeper identification for bird flu,” Brownstein said.
The nation’s flu surveillance systems “are built to be able to detect novel flu infections even during peak flu season” the CDC told ABC News in a statement in part. “The level of testing performed is designed to scale with increases in seasonal flu activity so that we’re casting a wider net and maintaining the ability to detect rare infections with novel influenza viruses.”
Other surveillance methods like emergency department trends and wastewater data may become less reliable as seasonal flu ramps up, Brownstein said.
“Patients that have access to rapid tests at home also aren’t necessarily collected and connected to surveillance systems” he added.
Risk of recombination
Questions have swirled about whether or not bird flu and seasonal influenza could form a recombinant virus, meaning a combination of the two.
There is currently no evidence that this has happened and, although it is possible for either virus to mutate with each new case, experts believe this is unlikely considering bird flu is not yet showing evidence of person-to-person transmission.
“It certainly is possible, but generally you get recombination when you have hosts where both strains can get in easily, and at the moment the bird flu strain is not traveling human to human, and so very, very few humans are infected with it,” Yang said. “It’s been a handful of cases, so the risk is really tiny.”
Moody said so-called “recombination events” do happen, with people becoming infected with multiple viruses at the same time or multiple strains of a virus. However, most of the time, they are “failures,” he said.
“That’s an important thing to understand, these recombination events are happening all the time and, most of the time, it doesn’t go anywhere,” Moody said. “Very, very rarely it does, and then that becomes a possibility for transmission”
How to best protect yourself
Moody and Yang say they both recommend that people receive the flu shot. Flu vaccines are currently available for everyone six months and older, according to the CDC.
In the last flu season prior to the COVID-19 pandemic, flu vaccination prevented an estimated 7 million illnesses, 3 million medical visits, 100,000 hospitalizations, and 7,000 deaths in the U.S., the CDC said.
The seasonal flu vaccine does not protect against bird flu, but it can reduce the risk of human influenza viruses, and therefore lower the risk of co-infection.
“Is there the potential for some cross-benefit for the avian flu? There may be. It’s hard to say, because, of course, these viruses are distinct from one another,” Moody said.
(NEW YORK) — The FDA has expanded the approval of Eli Lilly’s obesity medication Zepbound to include treating moderate to severe obstructive sleep apnea for people with obesity — the first medication approved for the condition.
The new, expanded Zepbound approval means that insurance providers, including Medicare, will likely cover the medication for people with sleep apnea and obesity. Some insurance providers, including Medicare, do not offer reimbursement to treat obesity alone.
The new approval is for people with moderate to severe obstructive sleep apnea who are also living with obesity. Eli Lilly estimates that is about 15-20 million adults in the U.S.
Obstructive sleep apnea isn’t just an inconvenience, it’s a serious medical condition that impairs breathing and sleep quality. Obesity and obstructive sleep apnea are linked. People tend to see their obstructive sleep apnea get better when they lose a significant amount of weight. It’s likely the weight loss associated with the medication is helping improve the sleep apnea.
Right now, there is no medicine to treat obstructive sleep apnea — it’s only treated with a positive airway pressure device.
In a study, people who took Zepbound had at least 25 fewer breathing interruptions per hour while they slept. They also lost an average of 20% of their body weight.
The study also followed people over a year, and found that up to half of the adults taking Zepbound no longer had obstructive sleep apnea symptoms at the end of the year.
Obstructive sleep apnea is more common in men than women. Up to 34% of U.S. men have OSA compared to 17% of U.S. women, according to the American Academy of Family Physicians.
Common signs of sleep apnea include heavy snoring at night, long pauses in breathing while sleeping as well as excessive daytime sleepiness, forgetfulness and morning headaches. The symptoms of the disorder can lead to significant medical problems.
Purdue Pharma headquarters; Victor J. Blue/Bloomberg via Getty Images
(NEW YORK) — The company and once-prominent family behind the drug OxyContin agreed Thursday to increase their financial contribution to resolve mass opioid litigation.
The Sacklers and Purdue Pharma boosted their settlement contribution to $7.4 billion after the U.S. Supreme Court overturned a prior settlement in June 2024. If approved, the new plan would end the costliest corporate bankruptcy resulting from the U.S. opioid crisis.
Purdue, under the leadership of the Sackler families, invented, manufactured and aggressively marketed opioid products for decades, according to the lawsuits. States and cities across the country said it fueled waves of addiction and overdose deaths.
The pharmaceutical company introduced OxyContin, a brand name of oxycodone, in the 1990s and filed for chapter 11 bankruptcy in 2019 after the company was sued thousands of times.
Under the settlement terms, the Sacklers’ control of Purdue Pharma ends. The $7.4 billion will go directly to communities across the U.S. — including states, counties, cities and territories — over the next 15 years to support opioid addiction treatment, prevention, and recovery programs.
“Families throughout New York and across the nation are suffering from the immense pain and loss wrought by the opioid crisis,” said New York Attorney General Letitia James, whose office helped negotiate the settlement agreement.
“The Sackler family relentlessly pursued profit at the expense of vulnerable patients, and played a critical role in starting and fueling in the opioid epidemic,” she continued. “While no amount of money will ever fully repair the damage they caused, this massive influx of funds will bring resources to communities in need so that we can heal.”
Purdue Pharma planned to exit bankruptcy last year under terms that gave the Sacklers a full release from all civil opioid claims even though they themselves were not declaring bankruptcy. In return, the Sacklers agreed to pay $6 billion.
The Supreme Court rejected the attempt by the Sacklers to use Purdue Pharma’s bankruptcy to shield themselves from liability.
Under the new terms, a significant amount of the settlement funds will be distributed in the first three years, with the Sacklers paying $1.5 billion and Purdue paying nearly $900 million in the first payment, followed by $500 million after one year, an additional $500 million after two years, and $400 million after three years.
A board of trustees selected by participating states in consultation with the other creditors will determine the future of the company. Purdue will continue to be overseen by a monitor and will be prevented from lobbying or marketing opioids.
“This story is about a family of cruel billionaires who believed they were above the law, pursued by states who never backed down,” Connecticut Attorney General William Tong said Thursday. “Today, we are forcing Purdue Pharma and the Sackler family to pay $7.4 billion for their role in igniting one of the most devastating public health crises in American history.”
Purdue Pharma said in a statement to ABC News, “We are extremely pleased that a new agreement has been reached that will deliver billions of dollars to compensate victims, abate the opioid crisis, and deliver treatment and overdose rescue medicines that will save lives. We have worked intensely with our creditors for months in mediation, and we are now focused on finalizing the details of a new Plan of Reorganization, which we look forward to presenting to the bankruptcy court.”
