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Rat poop, bug bits, mice hair: How many ‘unavoidable defects’ are in peanut butter and other foods you eat? | CNN

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CNN
—

Brace yourselves, America: Many of your favorite foods may contain bits and pieces of creatures that you probably didn’t know were there.

How about some mice dung in your coffee? Maggots in your pizza sauce? Bug fragments and rat hair in your peanut butter and jelly sandwich?

Oh, and so sorry, chocolate lovers. That dark, delicious bar you devoured might contain 30 or more insect parts and a sprinkling of rodent hair.

Called “food defects,” these dismembered creatures and their excrement are the unfortunate byproduct of growing and harvesting food.

“It is economically impractical to grow, harvest, or process raw products that are totally free of non-hazardous, naturally occurring, unavoidable defects,” the US Food and Drug Administration said.

So while there’s no way to get rid of all the creatures that might hitch a ride along the food processing chain, the FDA has established standards to keep food defects to a minimum.

Let’s go through a typical day of meals to see what else you’re not aware that you’re eating.

The coffee beans you grind for breakfast are allowed by the FDA to have an average of 10 milligrams or more animal poop per pound. As much as 4% to 6% of beans by count are also allowed to be insect-infested or moldy.

As you sprinkle black pepper on your morning eggs, try not to think about the fact you may be eating more than 40 insect fragments with every teaspoon, along with a smidgen of rodent hair.

Did you have fruit for breakfast? Common fruit flies can catch a ride anywhere from field to harvest to grocery store, getting trapped by processors or freezing in refrigerated delivery trucks and ending up in your home.

Let’s say you packed peanut butter and jelly sandwiches for everyone’s lunch. Good choice!

Peanut butter is one of the most controlled foods in the FDA list; an average of one or more rodent hairs and 30 (or so) insect fragments are allowed for every 100 grams, which is 3.5 ounces.

The typical serving size for peanut butter is 2 tablespoons (unless you slather). That means each 2 tablespoon-peanut butter sandwich would only have about eight insect fragments and a teensy bit of rodent filth. (“Filth” is what the FDA calls these insect and rodent food defects.)

Unfortunately, jelly and jam are not as controlled. Apple butter can contain an average of four or more rodent hairs for every 3.5 ounces (100 grams) and about five whole insects. Oh, and that isn’t counting the unknown numbers of teensy mites, aphids and thrips.

Apple butter can also contain up to 12% mold, which is better than cherry jam, which can be 30% moldy, or black currant jam, which can be 75% moldy.

Did you pack some of the kid-size boxes of raisins for your child’s midafternoon snack?

Golden raisins are allowed to contain 35 fruit fly eggs as well as 10 or more whole insects (or their equivalent heads and legs) for every 8 ounces. Kid-size containers of raisins are an ounce each. That’s more than four eggs and a whole insect in each box.

Any Bloody Mary fans? The tomato juice in that 14-ounce Bloody Mary could contain up to four maggots and 20 or more fruit fly eggs.

And if you’re having a fruity cocktail, just be aware that the canned citrus juices that many bars use can legally have five or more fruit fly eggs or other fly eggs per cup (a little less than 250 milliliters). Or that cup of juice could contain one or more maggots. Apricot, peach and pear nectars are allowed to contain up to 12% moldy fruit.

Oh, gosh, the possibilities are endless! Did you know there can be 450 insect parts and nine rodent hairs in every 16-ounce box of spaghetti?

Canned tomatoes, tomato paste and sauces such as pizza sauce are a bit less contaminated than the tomato juice in your cocktail. The FDA only allows about two maggots in a 16-ounce can.

Adding mushrooms to your spaghetti sauce or pizza? For every 4-ounce can of mushrooms there can be an average of 20 or more maggots of any size.

The canned sweet corn we love is allowed to have two or more larvae of the corn ear worm, along with larvae fragments and the skins the worms discard as they grow.

For every ¼ cup of cornmeal, the FDA allows an average of one or more whole insects, two or more rodent hairs and 50 or more insect fragments, or one or more fragments of rodent dung.

Asparagus can contain 40 or more scary-looking but teensy thrips for every ¼ pound. If those aren’t around, FDA inspectors look for beetle eggs, entire insects or heads and body parts.

Frozen or canned spinach is allowed to have an average of 50 aphids, thrips and mites. If those are missing, the FDA allows larvae of spinach worms or eight whole leaf miner bugs.

Dismembered insects can be found in many of our favorite spices as well. Crushed oregano, for example, can contain 300 or more insect bits and about two rodent hairs for every 10 grams. To put that in context, a family-size bottle of oregano is about 18 ounces or 510 grams.

Paprika can have up to 20% mold, about 75 insect parts and 11 rodent hairs for every 25 grams (just under an ounce). A typical spice jar holds about 2 to 3 ounces.

By now you must be asking: Just how do they count those tiny insect heads and pieces of rodent dung?

“Food manufacturers have quality assurance employees who are constantly taking samples of their packaged, finished product to be sure they’re not putting anything out that is against the rules,” said food safety specialist Ben Chapman, a professor in agricultural and human sciences at North Carolina State University.

Sometimes they do it by hand, Chapman said. “They take 10 bags out of a weeklong production and try to shake out what might be in here,” he said. “Do we have particularly high insect parts or was it a particularly buggy time of year when the food was harvested? And they make sure they are below those FDA thresholds.”

What happens if it was a buggy week and lots of insects decided to sacrifice themselves? Can they get all those eggs, legs and larvae out?

“They really can’t,” Chapman said. But they can take the food and send it to a process called “rework.”

“Say I’ve got a whole bunch of buggy fresh cranberries that I can’t put in a bag and sell,” Chapman said. “I might send those to a cranberry canning operation where they can boil them and then skim those insect parts off the top and put them into a can.”

That’s gross. Will I ever eat any of these foods again?

“Look, this is all a very, very, very low-risk situation,” Chapman said. “I look at it as a yuck factor versus a risk factor. Insect parts are gross, but they don’t lead to foodborne illnesses.”

Much more dangerous, Chapman points out, is the potential for stone, metal, plastic or glass parts to come along with harvested food as it enters the processing system. All foods are subjected to X-rays and metal detectors, Chapman said, because when those slip through, people can actually be hurt.

Also much more dangerous are foodborne illnesses such as salmonella, listeria and E. coli, which can severely sicken and even kill.

“Cross-contamination from raw food, undercooking food, hand-washing and spreading germs from raw food, those are the things that contribute to the more than 48 million cases of foodborne illness we have every year in the US,” Chapman said.

Well, put that way, I guess my disgust over that rodent poop in my coffee seems overblown.

Maybe.

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The planet is getting hotter fast. This is what happens to your body in extreme heat | CNN

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CNN
—

The Earth recently recorded its hottest day ever – a record experts warn will likely be repeatedly broken as the climate crisis drives temperatures higher and higher.

And it’s happening fast: a new report found last month was the planet’s hottest June by a “substantial margin,” meaning the nine hottest Junes have all occurred in the last nine years.

Extremely hot days – what could be considered the hottest days of the summer – are more frequent now than in 1970 in 195 locations across the US, according to the research group Climate Central. Of those locations, roughly 71% now face at least seven additional extremely hot days each year.

The effects have been devastating.

In one Texas county, at least 11 people died in just over a week during an unrelenting June heat wave. In Mexico, soaring temperatures have killed at least 112 people since March. A recent heat wave in India killed at least 44 people across the state of Bihar.

Here’s what happens to your body in extreme heat, what you need to watch out for and how to stay safe.

Normally, your body is used to a certain range of temperatures, usually between 97 to 99 degrees Fahrenheit. When your brain senses a change – either lower or higher than that – it attempts to help your body cool down or heat up, according to Dr. Judith Linden, executive vice chair of the department of emergency medicine at Boston Medical Center and a professor in the emergency medicine department at Boston University’s school of medicine.

“There are a number of different ways in which (the brain) attempts to cool the body down. One way, the most common way we think of, is that you sweat,” Linden said. “The pores open, the body sweats and the sweat evaporates, that cools the body.”

The second way your body cools itself down is by dilating vessels and upping your heart rate, which helps bring heat and blood to the surface of your body and helps releases that excess heat.

When you’re exposed to high temperatures, it becomes harder for your body to try and keep up with cooling itself down. And if your environment is hot and humid, sweat doesn’t evaporate as easily – which pushes your body’s temperature even higher, according to the Mayo Clinic.

“The higher the humidity, the lower temperatures you need for extreme heat,” Linden said.

High body temperatures can lead to damage to the brain and other vital organs, the CDC says. They can also lead to several heat-related illnesses.

Mild-heat related illnesses, including heat cramps, are most common, Linden said. Heat cramps can develop in people who sweat a lot, including during exercising. The excessive sweating uses up all of the body’s salt and moisture and can lead to muscle pains or spasms, usually in the abdomen, arms or legs, according to the CDC.

A heat rash can also develop. That’s a skin irritation caused by too much sweating in hot and humid weather, and is most common in young children, the CDC says. It is usually a red cluster of pimples or blisters, and tends to be in places including the neck, upper chest or in elbow creases.

When your body’s beginning to exceed its ability to cool itself down, you can develop what’s known as heat exhaustion.

“In this case you’re going to see excessive sweating because your body is really going to try and keep up with that extra heat. You’re going to feel light-headed, you may feel dizzy, often people present with nausea, headaches and their skin often looks pale and clammy and their pulse is often fast,” Linden said.

“This is the body’s last attempt to cool itself before it really goes into a point of no return.”

A heat stroke is the most serious heat-related illness, and, if left untreated, can lead to death.

“That’s where your body’s temperature goes above 104 to 105 degrees or so, and this is where your mechanisms are starting to fail,” Linden said.

Warning signs may include extremely high body temperatures, red and dry skin, a rapid pulse, headache, dizziness, nausea or loss of consciousness, according to the CDC.

The hallmark of a heat stroke is confusion and agitation, Linden said.

“So when somebody’s in the heat and they become confused and agitated, that’s heat stroke until proven otherwise and you need to call 911 for that or get help immediately and get the person out of the heat.”

Elderly, people with chronic medical conditions as well as children are at higher risk for severe heat-related illnesses.

The elderly and people with chronic medical conditions may be less likely to sense and respond to temperature changes and may be taking medication that make the heat effects worse, the CDC said.

“Very young (people) as well, because they’re less likely to recognize heat-related illness and they’re less likely to get out of the heat if they’re starting to feel overheated,” Linden said.

Student-athletes and pets are also at higher risk, she added.

“In this weather, you must never, ever, ever leave a child or a pet in the car for even a minute,” Linden added.

When your community is facing extreme heat, there are several things you can do to keep yourself and others safe.

First, keep an eye out for symptoms of heat exhaustion or other illnesses.

“If somebody starts feeling light-headed, dizzy, nausea or headache, that is the time to act immediately,” Linden said. “That means getting them out of the heat and into a cool environment.”

Putting water on someone who may be experiencing symptoms and giving them fluids can help cool them down. If someone is starting to lose consciousness or has nausea or vomiting, call 911.

“If you see anybody with any type of confusion, that’s an immediate red flag,” Linden added.

When it’s hot outside, try to avoid outdoor activities – especially between the hours of 11 a.m. and 3 p.m., according to Linden. If you have to go outside, wear light-colored clothing, cover your head and drink plenty of fluids.

Don’t wait until you’re thirsty to drink water – as that can be a sign of dehydration. Linden recommends drinking at least one glass of water – or more – an hour.

“If you do start to feel light-headed, dizzy, sweating, fast pulse, get out of the heat immediately,” Linden said.

Try to find air conditioning, or places in your area where you can go to stay cool, according to Ready.gov. Even spending a few hours in a shopping mall or public library can help.

When you’re home, fans can help, but don’t rely on them as your only way of cooling down – while it may feel more comfortable, they won’t help prevent heat-related illness.

“If you’re in a super hot room, if you’ve got a fan, is it helpful? No. I think, if you’ve got a fan, and you’re able to mist yourself … then fans can be helpful,” Linden said. “Fans are not foolproof.”

Finally, make sure you’re checking on your neighbors, parents and friends – especially older individuals who may be living alone or are isolated, Linden said.

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Ebola Fast Facts | CNN

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CNN
—

Here’s a look at Ebola, a virus with a high fatality rate that was first identified in Africa in 1976.

Ebola hemorrhagic fever is a disease caused by one of five different Ebola viruses. Four of the strains can cause severe illness in humans and animals. The fifth, Reston virus, has caused illness in some animals, but not in humans.

The first human outbreaks occurred in 1976, one in northern Zaire (now Democratic Republic of the Congo) in central Africa: and the other, in southern Sudan (now South Sudan). The virus is named after the Ebola River, where the virus was first recognized in 1976, according to the Centers for Disease Control and Prevention (CDC).

Ebola is extremely infectious but not extremely contagious. It is infectious, because an infinitesimally small amount can cause illness. Laboratory experiments on nonhuman primates suggest that even a single virus may be enough to trigger a fatal infection.

Ebola is considered moderately contagious because the virus is not transmitted through the air.

Humans can be infected by other humans if they come in contact with body fluids from an infected person or contaminated objects from infected persons. Humans can also be exposed to the virus, for example, by butchering infected animals.

Symptoms of Ebola typically include: weakness, fever, aches, diarrhea, vomiting and stomach pain. Additional experiences include rash, red eyes, chest pain, throat soreness, difficulty breathing or swallowing and bleeding (including internal).

Typically, symptoms appear eight to 10 days after exposure to the virus, but the incubation period can span two to 21 days.

Ebola is not transmissible if someone is asymptomatic and usually not after someone has recovered from it. However, the virus has been found in the semen of men who have recovered from Ebola and possibly could be transmitted from contact with that semen.

There are five subspecies of the Ebola virus: Zaire ebolavirus (EBOV), Bundibugyo ebolavirus (BDBV), Sudan ebolavirus (SUDV), Taï Forest ebolavirus (TAFV) and Reston ebolavirus (RESTV).

Click here for the CDC’s list of known cases and outbreaks.

(Full historical timeline at bottom)

March 2014 – The CDC issues its initial announcement on an outbreak in Guinea, and reports of cases in Liberia and Sierra Leone.

April 16, 2014 – The New England Journal of Medicine publishes a report, speculating that the current outbreak’s Patient Zero was a 2-year-old from Guinea. The child died on December 6, 2013, followed by his mother, sister and grandmother over the next month.

August 8, 2014 – Experts at the World Health Organization (WHO) declare the Ebola epidemic ravaging West Africa an international health emergency that requires a coordinated global approach, describing it as the worst outbreak in the four-decade history of tracking the disease.

August 19, 2014 – Liberia’s President Ellen Johnson Sirleaf declares a nationwide curfew beginning August 20 and orders two communities to be completely quarantined, with no movement into or out of the areas.

September 16, 2014 – US President Barack Obama calls the efforts to combat the Ebola outbreak centered in West Africa “the largest international response in the history of the CDC.” Speaking from the CDC headquarters in Atlanta, Obama adds that “faced with this outbreak, the world is looking to” the United States to lead international efforts to combat the virus.

October 6, 2014 – A nurse’s assistant in Spain becomes the first person known to have contracted Ebola outside Africa in the current outbreak. The woman helped treat two Spanish missionaries, both of whom had contracted Ebola in West Africa, one in Liberia and the other in Sierra Leone. Both died after returning to Spain. On October 19, Spain’s Special Ebola Committee says that nurse’s aide Teresa Romero Ramos is considered free of the Ebola virus.

October 8, 2014 – Thomas Eric Duncan, a Liberian citizen who was visiting the United States, dies of Ebola in Dallas.

October 11, 2014 – Nina Pham, a Dallas nurse who cared for Duncan, tests positive for Ebola during a preliminary blood test. She is the first person to contract Ebola on American soil.

October 15, 2014 – Amber Vinson, a second Dallas nurse who cared for Duncan, is diagnosed with Ebola. Authorities say Vinson flew on a commercial jet from Cleveland to Dallas days before testing positive for Ebola.

October 20, 2014 – Under fire in the wake of Ebola cases involving two Dallas nurses, the CDC issues updated Ebola guidelines that stress the importance of more training and supervision, and recommend that no skin be exposed when workers are wearing personal protective equipment, or PPE.

October 23, 2014 – Craig Spencer, a 33-year-old doctor who recently returned from Guinea, tests positive for Ebola – the first case of the deadly virus in New York and the fourth diagnosed in the United States.

October 24, 2014 – In response to the New York Ebola case, the governors of New York and New Jersey announce that their states are stepping up airport screening beyond federal requirements for travelers from West Africa. The new protocol mandates a quarantine for any individual, including medical personnel, who has had direct contact with individuals infected with Ebola while in Liberia, Sierra Leone or Guinea. The policy allows the states to determine hospitalization or quarantine for up to 21 days for other travelers from affected countries.

January 18, 2015 – Mali is declared Ebola free after no new cases in 42 days.

February 22, 2015 – Liberia reopens its land border crossings shut down during the Ebola outbreak, and President Sirleaf also lifts a nationwide curfew imposed in August to help combat the virus.

May 9, 2015 – The WHO declares an end to the Ebola outbreak in Liberia. More than 4,000 people died.

November 2015 – Liberia’s health ministry says three new, confirmed cases of Ebola have emerged in the country.

December 29, 2015 – WHO declares Guinea is free of Ebola after 42 days pass since the last person confirmed to have the virus was tested negative for a second time.

January 14, 2016 – A statement is released by the UN stating that “For the first time since this devastating outbreak began, all known chains of transmission of Ebola in West Africa have been stopped and no new cases have been reported since the end of November.”

March 29, 2016 – The WHO director-general lifts the Public Health Emergency of International Concern related to the 2014-2016 Ebola outbreak in West Africa.

*Includes information about Ebola and other outbreaks resulting in more than 100 deaths or special cases.

1976 – First recognition of the EBOV disease is in Zaire (now Democratic Republic of the Congo). The outbreak has 318 reported human cases, leading to 280 deaths. An SUDV outbreak also occurs in Sudan (now South Sudan), which incurs 284 cases and 151 deaths.

1995 – An outbreak in the Democratic Republic of the Congo (DRC) leads to 315 reported cases and at least 250 deaths.

2000-2001 – A Ugandan outbreak (SUDV) results in 425 human cases and 224 deaths.

December 2002-April 2003 – An EBOV outbreak in ROC results in 143 reported cases and 128 deaths.

2007 – An EBOV outbreak occurs in the DRC, 187 of the 264 cases reported result in death. In late 2007, an outbreak in Uganda leads to 37 deaths, with 149 cases reported in total.

September 30, 2014 – Dr. Thomas Frieden, director of the CDC, announces the first diagnosed case of Ebola in the United States. The person has been hospitalized and isolated at Texas Health Presbyterian Hospital in Dallas since September 28.

July 31, 2015 – The CDC announces that a newly developed Ebola vaccine is “highly effective” and could help prevent its spread in the current and future outbreaks.

December 22, 2016 – The British medical journal The Lancet publishes a story about a new Ebola vaccine that tested 100% effective during trials of the drug. The study was conducted in Guinea with more than 11,000 people.

August 1, 2018 – The DRC’s Ministry of Health declares an Ebola virus outbreak in five health zones in North Kivu province and one health zone in Ituri province. On July 17, 2019, the WHO announces that the outbreak constitutes a public health emergency of international concern. On June 25, 2020, the DRC announces that the outbreak is officially over. A total of 3,481 cases were reported, including 2,299 deaths and 1,162 survivors.

August 12, 2019 – Two new Ebola treatments are proving so effective they are being offered to all patients in the DRC. Initial results found that 499 patients who received the two effective drugs had a higher chance of survival – the mortality rate for REGN-EB3 and mAb114 was 29% and 34% respectively. The two drugs worked even better for patients who were treated early – the mortality rate dropped to 6% for REGN-EB3 and 11% for mAb114, according to Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and one of the researchers leading the trial.

December 19, 2019 – The US Food and Drug administration announces the approval of a vaccine for the prevention of the Ebola virus for the first time in the United States. The vaccine, Ervebo, was developed by Merck and protects against Ebola virus disease caused by Zaire ebolavirus in people 18 and older.

October 14, 2020 – Inmazeb (REGN-EB3), a mixture of three monoclonal antibodies, becomes the first FDA-approved treatment for the Ebola virus. In December, the FDA approves a second treatment, Ebanga (mAb114).

January 14, 2023 – Ugandan authorities officially declare the end of a recent Ebola outbreak after 42 consecutive days with no new cases.

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Zika Virus Infection Fast Facts | CNN

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CNN
—

Here’s a look at Zika virus, an illness spread through mosquito bites that can cause birth defects and other neurological defects.

Sources: Centers for Disease Control and Prevention (CDC), World Health Organization (WHO) and CNN

Zika virus is a flavivirus, part of the same family as yellow fever, West Nile, chikungunya and dengue fever.

Zika is primarily transmitted through the bite of an infected female Aedes aegypti mosquito. It becomes infected from biting an infected human and then transmits the virus to another person. The Aedes aegypti mosquito is an aggressive species, active day and night and usually bites when it is light out. The virus can be transmitted from a pregnant woman to her fetus, through sexual contact, blood transfusion or by needle.

The FDA approved the first human trial of a Zika vaccine in June 2016. As of May 2022, there is still no available vaccine or medication.

Cases including confirmed, probable or suspected cases of Zika in US states and territories updated by the CDC.

Most people infected with Zika virus won’t have symptoms. If there are symptoms, they will last for a few days to a week.

Fever, rash, joint pain and conjunctivitis (red eyes) are the most common symptoms. Some patients may also experience muscle pain or headaches.

Zika virus infection during pregnancy can cause microcephaly, a neurological disorder that results in babies being born with abnormally small heads. Microcephaly can cause severe developmental issues and sometimes death. A Zika infection may cause other birth defects, including eye problems, hearing loss and impaired growth. Miscarriage can also occur.

An August 2018 report published by the CDC estimates that nearly one in seven babies born to women infected with the Zika virus while pregnant had one or more health problems possibly caused by the virus, including microcephaly.

According to the CDC, there is no evidence that previous infection will affect future pregnancies.

(Sources: WHO, CDC and CNN)

1947 – The Zika virus is first discovered in a monkey by scientists studying yellow fever in Uganda’s Zika forest.

1948 – The virus is isolated from Aedes africanus mosquito samples in the Zika forest.

1964 – First active case of Zika virus found in humans. While researchers had found antibodies in the blood of people in both Uganda and in Tanzania as far back as 1952, this is the first known case of the active virus in humans. The infected man developed a pinkish rash over most of his body but reported the illness as “mild,” with none of the pain associated with dengue and chikungunya.

1960s-1980s – A small number of countries in West Africa and Asia find Zika in mosquitoes, and isolated, rare cases are reported in humans.

April-July 2007 – The first major outbreak in humans occurs on Yap Island, Federated States of Micronesia. Of the suspected 185 cases reported, 49 are confirmed, and 59 are considered probable. There are an additional 77 suspected cases. No deaths are reported.

2008 – Two American researchers studying in Senegal become ill with the Zika virus after returning to the United States. Subsequently, one of the researchers transmits the virus to his wife.

2013-2014 – A large outbreak of Zika occurs in French Polynesia, with about 32,000 suspected cases. There are also outbreaks in the Pacific Islands during this time. An uptick in cases of Guillain-Barré Syndrome during the same period suggests a possible link between the Zika virus and the rare neurological syndrome. However, it was not proven because the islands were also experiencing an outbreak of dengue fever at the time.

March 2015 – Brazil alerts the WHO to an illness with skin rash that is present in the northeastern region of the country. From February 2015 to April 29, 2015, nearly 7,000 cases of illness with a skin rash are reported. Later in the month, Brazil provides additional information to WHO on the illnesses.

April 29, 2015 – A state laboratory in Brazil informs the WHO that preliminary samples have tested positive for the Zika virus.

May 7, 2015 – The outbreak of the Zika virus in Brazil prompts the WHO and the Pan American Health Organization (PAHO) to issue an epidemiological alert.

October 30, 2015 – Brazil reports an increase in the cases of microcephaly, babies born with abnormally small heads: 54 cases between August and October 30.

November 11, 2015 – Brazil declares a national public health emergency as the number of newborns with microcephaly continues to rise.

November 27, 2015 – Brazil reports it is examining 739 cases of microcephaly.

November 28, 2015 – Brazil reports three deaths from Zika infection: two adults and one newborn.

January 15 and 22, 2016 – The CDC advises all pregnant women or those trying to become pregnant to postpone travel or consult their physicians prior to traveling to any of the countries where Zika is active.

February 2016 – The CDC reports Zika virus in brain tissue samples from two Brazilian babies who died within a day of birth, as well as in fetal tissue from two miscarriages providing the first proof of a potential connection between Zika and the rising number of birth defects, stillbirths and miscarriages in mothers infected with the virus.

February 1, 2016 – The WHO declares Zika a Public Health Emergency of International Concern due to the increase of neurological disorders, such as microcephaly, in areas of French Polynesia and Brazil.

February 8, 2016 – The CDC elevates its Emergency Operations Center for Zika to Level 1, the highest level of response at the CDC.

February 26, 2016 – Amid indications that the mosquito-borne Zika virus is causing microcephaly in newborns, the CDC advises pregnant women to “consider not going” to the Olympics in Rio de Janeiro. The CDC later strengthens the advisory, telling pregnant women, “Do not go to the Olympics.”

March 4, 2016 – The US Olympic Committee announces the formation of an infectious disease advisory group to help the USOC establish “best practices regarding the mitigation, assessment and management of infectious disease, paying particular attention to how issues may affect athletes and staff participating in the upcoming Olympic and Paralympic Games.”

April 13, 2016 – During a press briefing, CDC Director Thomas Frieden said, “It is now clear the CDC has concluded that Zika does cause microcephaly. This confirmation is based on a thorough review of the best scientific evidence conducted by CDC and other experts in maternal and fetal health and mosquito-borne diseases.”

May 27, 2016 – More than 100 prominent doctors and scientists sign an open letter to WHO Director General Margaret Chan, calling for the summer Olympic Games in Rio de Janeiro to be postponed or moved “in the name of public health” due to the widening Zika outbreak in Brazil.

July 8, 2016 – Health officials in Utah report the first Zika-related death in the continental United States.

August 1, 2016 – Pregnant women and their partners are advised by the CDC not to visit the Miami neighborhood of Wynwood as four cases of the disease have been reported in the small community and local mosquitoes are believed to be spreading the infection.

September 19, 2016 – The CDC announces that it has successfully reduced the population of Zika-carrying mosquitoes in Wynwood and lifts its advisory against travel to the community.

November 18, 2016 – The WHO declares that the Zika virus outbreak is no longer a public health emergency, shifting the focus to long-term plans to research the disease and birth defects linked to the virus.

November 28, 2016 – Health officials announce Texas has become the second state in the continental United States to confirm a locally transmitted case of Zika virus.

September 29, 2017 – The CDC deactivates its emergency response for Zika virus, which was activated in January 2016.

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Autism Fast Facts | CNN

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CNN
—

Here is a look at autism.

Autism or autism spectrum disorder (ASD) incorporates a group of neurodevelopmental disorders causing impaired communication skills and social skills. ASD generally starts before three years of age and lasts a lifetime, but early intervention plays a role in treatment and progress.

ASD is about four times more common among boys than girls, according to the Centers for Disease Control and Prevention (CDC).

ASD can be found among all races, ethnicities and socioeconomic groups.

The prevalence of ASD in the United States is about one in 36 8-year-olds, according to a 2023 CDC report.

Health care costs for children with autism are four to six times greater than medical costs for children without autism, according to research published in the Journal of Autism and Developmental Disorders.

April 2 is World Autism Day.

There is no definitive medical test to diagnose autism. Instead, the disorder is diagnosed by observing a child’s development.

According to the CDC, signs of autism may include deficits in social communication and interaction in a variety of contexts, difficulty engaging in back-and-forth conversation and an absence of interest in forming friendships with peers.

The debate over whether autism spectrum disorders are caused by vaccines started in 1998 when the medical journal The Lancet published a now-retracted study by researcher Andrew Wakefield linking the MMR vaccine to autism.

Most of Wakefield’s co-authors withdrew their names from the study when they learned he had been compensated by a law firm intending to sue manufacturers of the vaccine in question. In 2010, Wakefield lost his medical license. In 2011, the Lancet retracted the study after an investigation found Wakefield altered or misrepresented information on the 12 children who were the basis for the conclusion of the study.

Other researchers have not been able to replicate Wakefield’s findings. Several subsequent studies trying to reproduce the results have found no link between vaccines and autism, including several reviews by the Institute of Medicine.

Early 1900s – Autistic characteristics are studied as symptoms of schizophrenia.

1938 – Donald Gray Triplett of Mississippi is first examined by child psychiatrist Leo Kanner of Johns Hopkins Hospital and later becomes the first person diagnosed with autism symptoms.

1943 – Triplett is identified as “Donald T.” in the paper “Autistic Disturbances of Affective Contact” by Kanner. The paper elaborates on the idea that autism is related to lack of parental warmth; this is later dubbed the “refrigerator mother” theory.

1944 – Hans Asperger, an Austrian physician, publishes a paper about autistic syndrome. The paper gains wider recognition when it is translated into English in the early 1990s.

1964 – Bernard Rimland, a research psychologist, publishes “Infantile Autism: The Syndrome and Its Implications for a Neural Theory of Behavior,” which contradicts the “refrigerator mother” hypothesis. Kanner is the author of the foreword.

1965 – Rimland founds the National Society for Autistic Children (now the Autism Society). He later establishes the Autism Research Institute.

1980 – Autism is classified separately from schizophrenia in the third edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-III).

December 18, 2007 – The United Nations adopts a resolution declaring April 2 World Autism Awareness Day.

October 29, 2014 – The medical journal Nature reports that scientists have identified 60 genes with a greater than 90% chance of increasing a child’s autism risk.

December 17, 2015 – Scientists at Harvard and MIT announce they have found, for the first time, a link between autistic behavior and reduced activity of a key neurotransmitter, a type of brain chemical that enables the transmission of signals across neurons, allowing the brain to communicate with other organs.

April 21, 2016 – The Simons Foundation announces that it is launching an autism research project called SPARK. The study, which involves scientists at 21 hospitals and university clinics, will focus on the possible connection between genetics and autism. Parents of children with autism are invited to sign up online and participate in the study. The group also works with Autism Speaks and the Autism Science Foundation to run the Autism BrainNet network, which is an autism brain bank that collects postmortem donations.

February 2017 – Researchers find that monitoring MRI brain scans of infants may help predict whether they will develop autism, according to a study published in the journal, Nature. The researchers found a possible link between brain enlargement during the first year of life and an autism diagnosis at age 2. This builds on previous similar research.

March 19, 2017 – CBS News’ “60 Minutes” profiles “Sesame Street’s” newest Muppet character, a girl named Julia who has autism.

April 11, 2017 – A study published in the American Journal of Public Health finds that people with autism are three times more likely than the general population to die because of preventable injuries, and children and young teens with autism are 40 times more likely to die from preventable injury than the general child population. Suffocation, asphyxiation and drowning are the leading causes of fatal injuries among people with autism.

March 26, 2018 – According to a study published in JAMA Pediatrics, children with autism spectrum disorder and their younger siblings are less likely to be fully vaccinated than children unaffected by autism.

March 4, 2019 – A study of over 650,000 children published in the journal Annals of Internal Medicine shows that the measles, mumps, and rubella vaccine does not increase the risk of autism and does not trigger autism in children who are at risk.

April 29, 2019 – A study published in JAMA Pediatrics suggests that children can be screened for autism spectrum disorder at 14 months of age with high accuracy (instead of 18 to 24 months of age, as is currently recommended).

January 23, 2020 – A study in the journal Cell identifies 102 genes that are associated with an autism risk. Previously, researchers were only aware of 65.

May 10, 2020 – In a report published in the Journal of Autism and Developmental Disorders, the CDC estimates that 2.2% of Americans adults have autism spectrum disorder. The report, which is the first US study of autism in adults, indicates that up to 5.4 million people age 18 and older, or about 1 in 45 people, have an autism spectrum condition.

February 14, 2022 – A meta-analysis published in JAMA Pediatrics finds that early mortality, due to natural or unnatural causes, is more than two times more likely for people with autism spectrum disorder than the general population.

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Mpox in the United States Fast Facts | CNN

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Editor’s Note: This story has been updated to include the WHO’s updated recommendation for what the virus should be called.

CNN
—

Here’s a look at mpox, formerly known as monkeypox, in the United States. In 2022, an outbreak was declared a public health emergency of international concern by the World Health Organization (WHO). The virus originated in Africa and is the cousin of the smallpox virus.

In November 2022, WHO renames the monkeypox virus as mpox after working with International Committee on the Taxonomy of Viruses (ICTV) to rename the the virus using non-stigmatizing, non-offensive social and cultural nomenclature.

(Source: Centers for Disease Control and Prevention)

Mpox is a poxvirus. It generally causes pimple- or blister-like lesions and flu-like symptoms such as fever. The disease is rarely fatal.

Mpox spreads through close contact. This includes direct physical contact with lesions as well as “respiratory secretions” shared through face-to-face interaction and touching objects that have been contaminated by mpox lesions or fluids. The virus may also pass to a fetus through the placenta.

Anyone can become ill from mpox, but the US Centers for Disease Control and Prevention (CDC) says that more than 99% of mpox cases in the United States in the 2022 outbreak have been among men who have sex with men. However, mpox is not generally considered a sexually transmitted disease.

Mpox is usually found in West and Central Africa, but additional cases have been seen in Europe, including the United Kingdom, and other parts of the world in recent years. Those cases are typically linked to international travel or imported animals infected with the poxvirus.

CDC Mpox Map and Case Count

WHO Situation Reports

1958 – Mpox is discovered when monkeys kept for research cause two outbreaks in Copenhagen, Denmark.

1970 – The first human case is recorded in Zaire (now the Democratic Republic of Congo).

2003 – An outbreak in the United States is linked to infected pet prairie dogs imported from Ghana and results in more than 80 cases.

July 16, 2021 – The CDC and local health officials in Dallas announce they are investigating a case of mpox in a traveler from Nigeria. “The individual is a City of Dallas resident who traveled from Nigeria to Dallas, arriving at Love Field airport on July 9, 2021. The person is hospitalized in Dallas and is in stable condition,” the Dallas County Department of Health and Human Services says in a statement.

May 17, 2022 – The first confirmed US case of mpox in the 2022 outbreak is reported to the CDC in a traveler who returned to Massachusetts from Canada.

May 19, 2022 – WHO reports that death rates of the outbreak have been between 3% and 6%.

May 23, 2022 – The CDC announces the release of mpox vaccine doses from the nation’s Strategic National Stockpile for “high-risk people.” In the United States, the two-dose Jynneos vaccine is licensed to prevent smallpox and specifically to prevent mpox.

May 26, 2022 – CDC Director Dr. Rochelle Walensky announces that the United States is distributing the vaccine to states with reported cases and recommends vaccination for people at highest risk of infection due to direct contact with someone who has mpox.

June 22, 2022 – The CDC announces a partnership with five commercial laboratories to ramp up testing capacity in the United States.

June 23, 2022 – New York City launches the first mpox vaccination clinic in the United States.

June 28, 2022 – The US Department of Health and Human Services (HHS) and the Biden administration announce an enhanced vaccination strategy and report that more than 9,000 doses of vaccine have been distributed to date.

July 22, 2022 – Two American children contract mpox – a first in the United States. According to the CDC, the two cases are unrelated.

July 23, 2022 – WHO declares mpox a public health emergency of international concern, “an extraordinary event that may constitute a public health risk to other countries through international spread of disease and may require an international coordinated response.”

July 27, 2022 – After weeks of mpox vaccines being in limited supply, more than 786,000 additional doses are made available in the United States, according to HHS.

July 29, 2022 – New York declares a state disaster emergency in response to the mpox outbreak.

August 1, 2022 – California and Illinois declare states of emergency. California has reported more than 800 cases, while Illinois has had more than 500, according to data from the CDC.

August 2, 2022 – An mpox response team is created by the Biden administration. President Joe Biden names Robert Fenton from the Federal Emergency Management Agency (FEMA) as the White House national mpox response coordinator.

August 2, 2022 – A report from Spain’s National Institute for Microbiology indicates two men, ages 31 and 44, who died from mpox in unrelated cases had both developed encephalitis, or swelling of the brain, which can be triggered by viral infections. Encephalitis is a very rare condition known to be associated with mpox. It has been reported in people with mpox in West Africa and in a patient in the United States in 2003 during the small outbreak linked to imported prairie dogs.

August 4, 2022 – The Biden administration declares the mpox outbreak a national public health emergency.

August 5, 2022 – A report published by the CDC finds that 94% of cases were among men who had recent sexual or close intimate contact with another man. Further, 54% of cases were among Black Americans and Latinos.

August 9, 2022 – In an effort to stretch the limited supply of the Jynneos mpox vaccine, federal health officials authorize administering smaller doses using a different method of injection. The new injection strategy allows health-care providers to give shallow injections intradermally, in between layers of the skin, with one-fifth the standard dose size instead of subcutaneously, into the fatty layer below the skin, with the larger dose.

August 18, 2022 – The White House announces the acceleration of the HHS vaccine distribution timeline, with an additional 1.8 million doses of the Jynneos vaccine being made available. Additional vaccines will be distributed to communities hosting large LGBTQI+ events.

August 19, 2022 – Washington’s King County, which includes Seattle, declares mpox a public health emergency, with more than 270 recorded cases.

September 12, 2022 – The first US death due to mpox is confirmed in Los Angeles County, California.

May 11, 2023 – WHO declares the mpox outbreak is no longer a global health emergency.

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FDA advisers narrowly vote in favor of experimental gene therapy for rare muscle disease | CNN

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CNN
—

Most parents wouldn’t be thrilled with the idea of their kids getting hooked up to an IV bag filled with trillions of viruses.

But for Melanie Hennick, whose son, Connor, has Duchenne muscular dystrophy, it was an opportunity she hoped would change his life.

“We knew this wasn’t a cure,” Hennick said. “But it was a chance.”

Connor is one of just dozens of kids to have received SRP-9001, an experimental gene therapy that aims to slow or stop the progression of Duchenne muscular dystrophy, or DMD. Current treatments for the disease – which primarily affects boys because of the way it’s inherited – include steroids and, later, heart drugs. But none stop it.

SRP-9001 uses viruses to ferry a copy of a gene to muscles to help make up for one that’s causing the disease. Hennick and many other parents like her advocated for the treatment’s accelerated approval Friday in a meeting of outside advisers to the US Food and Drug Administration.

The advisers voted 8-6 in favor of approving the treatment, and the FDA will now decide whether to follow their advice.

“The decision the FDA has to make doesn’t just affect the patients in study 301 [an ongoing confirmatory trial that Sarepta is running]; it affects the entire field of drug development for Duchenne,” said Dr. Caleb Alexander, a professor of epidemiology and medicine in the Bloomberg School of Public Health at Johns Hopkins University, who voted against recommending approval. “The totality of evidence … simply doesn’t rise to the threshold that’s required for accelerated approval.”

Dr. Raymond Roos, a neurology professor at the University of Chicago Medical Center, voted in favor. “The downside of the gene therapy here is relatively small compared to whether it really helps the patient, and for this reason, I voted yes,” he said.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said his agency will take the recommendation and “do something that we have to do every day at FDA. … We have to manage through the uncertainty here.”

The FDA’s decision, expected by the end of the month, will have implications not just for families like Connor’s but for how the agency regulateths treatments like this one more broadly: It would be the first of its kind of medicine – one-time treatments delivering a gene to try to fix a disease – to get accelerated approval, a faster track through the regulatory process. Its approval would set a precedent for other drugs like this based on so-called surrogate endpoints, a measure of what the drug does in the body, before further clinical evidence is available.

“Approval of a gene therapy for Duchenne muscular dystrophy will be huge,” said Jeffrey Chamberlain, a professor at the University of Washington School of Medicine who helped pioneer gene therapy approaches for the disease. “This, I think, will spur further research and further development of gene therapies for other diseases.”

DMD patients don’t have a lot of time to wait. Kids with Duchenne typically lose the ability to walk before they’re teenagers and often don’t live well into their 30s, Chamberlain said. He’s not directly involved with SRP-9001, which is being developed by Sarepta Therapeutics, and is on the scientific advisory board for another company working on DMD gene therapies, Solid Biosciences.

“Gene therapy appears to be a really good approach to try to treat this disease, because it’s a genetic disease,” Chamberlain said. “The cause of the disease is a mutation in a single gene.”

That gene is responsible for the production of dystrophin, a protein key to the structure of muscle cells.

“It’s kind of like the two-by-fours that make up your house,” Chamberlain said. “It’s really important for just holding everything together.”

SRP-9001, invented at Nationwide Children’s Hospital in Columbus, Ohio, before being licensed for development by Sarepta, delivers a miniaturized version of the dystrophin gene to cells, aiming to help them make a version of the muscle-preserving protein.

In a key clinical trial, the therapy appeared to do that. But it didn’t meet another main goal: showing a benefit on a measure of muscle function, complicating SRP-9001’s path through the FDA.

Sarepta blamed the outcome on an imbalance in how the trial separated patients into the placebo and treatment groups. But key FDA reviewers appear unconvinced.

“The clinical studies conducted to date do not provide unambiguous evidence that SRP-9001 is likely beneficial for ambulatory patients with DMD,” agency reviewers wrote in briefing documents released ahead of Friday’s meeting, referring to patients who can still walk – the group who will initially be eligible for the treatment if it gets approved.

Family after family who participated in Sarepta’s trials, like the Hennicks, disagree with the reviewers. They say they believe that the treatment has helped keep their kids walking and running in ways they never would have without it.

“It’s really miraculous,” said Nate Plasman, whose son Andrew got SRP-9001 as part of the trial in January 2019, at age 4.

Sara, left, Andrew and Nate Plasman on the day he was dosed in the trial in January 2019.

Andrew was away from school for more than two months when he got the experimental therapy, Plasman said, and when he returned, “his teachers at the preschool were blown away,” he recalled. “They’re like, ‘Who is this kid?’ He’s running. He’s jumping. He’s pedaling the tricycle. He’s getting up and down off the ground” – all things he couldn’t do as well before the therapy.

Marit Sivertson, mom to 9-year-old Brecken, agrees.

“We’ve seen the incredible changes with our son,” she said. “He’s not just walking around. He’s running; he’s swimming; he’s diving. He’s truly living the life that every 9-year-old boy ought to be living.”

Dr. Jerry Mendell of Nationwide Children's Hospital in Ohio, who developed the gene therapy, left, with Brecken Kinney.

Sivertson and Plasman also spoke at Friday’s meeting. Their goal isn’t to secure the therapy for their own kids; because it’s designed as a one-time treatment, they wouldn’t take it again. They say they’re speaking up on behalf of children who are still waiting.

That wait is especially painful for Daniel and Lindsey Flessner, who have two sons with DMD. Their 5-year-old son, Mason, is in the SRP-9001 clinical trial. Their 2-year-old, Dawson, is still too young.

“With every trip, every fall, every time he stands up by walking up his legs using his hands to help stabilize him, it just keeps chipping away at us,” Flessner said. “It’s very painful as the parents watching your children struggling knowing all you can do is wait, when waiting is what you don’t have time for.”

Lindsey and Daniel Flessner's sons, Mason and Dawson, both have DMD.

In addition to questions about how well the treatment works, the FDA reviewers raised concerns about safety, particularly “related to the possibility of administering an ineffective gene therapy.”

The reviewers focused on opportunity cost: Because of the viruses used to deliver the gene, patients can develop an immune response that could render future doses ineffective.

Chamberlain said work is underway to find ways to be able to administer more doses, if needed, but it’s currently a one-and-done treatment.

For now, he thinks this approach is the best hope for DMD patients.

“It’s not perfect,” he acknowledged. “It’s not a complete cure, but from what I can gauge from the clinical results that have been released by Sarepta and some of the other companies, I think the micro-dystrophin gene therapy is working better than any other drug that’s been tried for Duchenne muscular dystrophy.”

It’s unclear how long the effects will last; Sarepta is continuing trials, and a confirmatory study would be required as part of accelerated approval. Sarepta has proposed a trial that it’s already running to satisfy that requirement, with results expected later this year.

For families facing DMD, there’s an opportunity cost to waiting, too. In its briefing documents for the FDA meeting, Sarepta estimated that accelerated approval would speed up broad access to SRP-9001 by at least a year, a time in which about 400 boys could lose the ability to walk and another 400, whose disease is more advanced, would die.

Melanie Hennick said Connor was admitted to the trial just weeks before he’d have aged out, at 8 years old. She said she believes the therapy is the reason Connor’s doing so well.

“We had the opportunity to see Connor grow as an 8-, 9-, 10-, 11- and 12-year-old with more capacity than we ever dreamed,” she said. “He climbs stairs unaided; he runs around; he plays football; he plays hockey; he plays on a baseball team. … Those are things that we never thought we would be able to see him do, especially at 12.”

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‘We never want to have this happen again,’ FDA official testifies about formula shortage | CNN

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CNN
—

In a rare moment of bipartisan agreement, lawmakers were highly critical of the US Food and Drug Administration’s handling of the infant formula shortage Thursday.

The hearing of the US House Oversight and Accountability Subcommittee on Health Care and Financial Services was one of several Congress has held to better understand what contributed to the recent formula shortage and to understand how to prevent more problems down the road.

Rep. Lisa McClain, R-Michigan, said that the FDA has not been fully forthcoming with Congress and the public.

“Why was the FDA unprepared for the crisis?” she asked in her opening statement.

She said that the agency failed to prioritize food safety. “The FDA has not taken the action needed to prevent a similar crisis from happening again.”

Rep. Katie Porter, D-California, said she agreed with McClain that another shortage could happen, “and that is a deadly serious problem.”

“There is a lot of blame to go around,” Porter added. “It’s clear with today’s witness selection that Republicans want to blame the FDA, and I’ll level with you, I think some of that blame is well-placed. We’ve had two subsequent infant formula recalls in 2023 already, and we’re still seeing that the FDA can make further improvements on internal processes, intervene in issues sooner and follow through with more inspections to prevent further contamination.”

Three major manufacturers in the US control over 90% of the formula market, and that consolidation is a “serious concern” that “contributed significantly to shortages,” according to Dr. Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, who testified Thursday.

A shortage that started in 2021 was exacerbated when the country’s largest infant formula maker, Abbott Nutrition, recalled multiple products in mid-February 2022 and had to pause production at its plant in Sturgis, Michigan, after FDA inspectors found potentially dangerous bacteria.

The plant inspection was tied to an outbreak of Cronobacter sakazakii that had sickened at least four infants and killed two, although investigations did not find a genetic link between bacteria samples from the facility and bacteria found in the water and powder used to mix the formula that the infants had consumed.

Mayne testified that it was difficult to trace the cases and determine how big of a concern the outbreak was. The bacteria is a common pathogen in the environment “but one about which we have limited information.”

The FDA has urged the US Centers for Disease Control and Prevention to make Cronobacter infection a notifiable disease – meaning providers would be required to report cases to local or state public health officials – so public health experts would be able to more quickly determine the source of any contamination.

In addition to the bacteria, an FDA inspection of the Sturgis plant found unsanitary conditions and several violations of food safety rules.

A whistleblower had alerted the FDA to alleged safety lapses at the plant in February 2021, months before Abbott’s formula was recalled. The complaint suggested that the plant lacked proper cleaning practices and that workers falsified records and hid information from inspectors.

Like other FDA leaders who have been called before Congress, Mayne testified that she was not made aware of the complaint right away. She called it “a failure of escalation.”

“I do wish I had been made aware of this particular whistleblower complaint, but just to reiterate, the complaint was acted upon,” Mayne said. However, she noted, it was “less than ideal” how quickly there was an FDA inspection of the plant and how quickly the agency was able to act.

When the whistleblower made the complaint, there was no process within the FDA to escalate it. The process has since changed so that if a complaint meets certain criteria involving vulnerable populations, hospitalizations or deaths, leadership would be immediately informed. If a consumer complaint involves an infant death or hospitalization, it also immediately gets escalated to leadership.

To prevent future shortages, Mayne testified, it won’t just be the FDA that needs to change. The industry should do more to adopt enhanced food safety measures to “deliver the safest possible” infant formula, she said.

The agency would also like better regulations. There have been been two infant formula recalls already in 2023, and in neither case was the manufacturer required to notify the FDA that it had found contamination before the formula left the plant.

The FDA has asked formula makers to inform the agency about positive tests, but such reporting is only voluntary. If it were mandatory, the FDA could know about problems in real time and could take action.

“Our food safety experts, our compliance experts can work with the manufacturers,” Mayne said. In such a collaboration, they could quickly identify what product to focus on to prevent a shortage.

The FDA has taken recent steps to improve. In February, it announced that it is restructuring its food division to be more responsive and that it is creating an office of critical foods. The FDA is also hiring specialized infant formula inspection staff, Mayne said.

The infant formula supply is generally in good shape, she said, but there are still some distribution issues.

The in-stock rate is near 90%, even higher than pre-recall levels. But some rural areas are having a hard time getting all the formula they need.

Formula manufacturers have been producing more than is being purchased week after week to build up supply, Mayne said. The Biden administration has also worked to bring in formula from manufacturers overseas.

But another shortage is not out of the question, particularly if one of the country’s main manufacturers is taken offline for any significant amount of time.

“We never want to have this happen again,” Mayne said.

Lawmakers have proposed significant cuts, about 22%, to the FDA’s budget for 2023. Mayne said that consumers and the industry would be “adversely affected” if the cuts go through.

“Broadly, across the FDA, I can say it would be devastating,” she said, resulting in a loss of 32% of domestic inspections and 22% of foreign inspections. The cuts would also disproportionately affect its food programs, which get much of their funding from the budget, unlike divisions involving drugs that get money from user fees.

“We would be unable to do what I think American consumers expect us to do,” Mayne said.

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FDA advisers vote unanimously in support of over-the-counter birth-control pill | CNN

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CNN
—

Advisers for the US Food and Drug Administration voted unanimously on Wednesday in support of making the birth-control pill Opill available over-the-counter, saying the benefits outweigh the risks.

Two FDA advisory panels agreed that people would use Opill safely and effectively and said groups such as adolescents and those with limited literacy would be able to take the pill at the same time every day without help from a health care worker.

The advisers were asked to vote on whether people were likely to use the tablet properly so that the benefits would exceed the risks. Seventeen voted yes. Zero voted no or abstained.

Opill manufacturer Perrigo hailed the vote as a “groundbreaking” move for women’s health.

“Perrigo is proud to lead the way in making contraception more accessible to women in the U.S.,” Murray Kessler, Perrigo’s president and CEO, said in a statement. “We are motivated by the millions of people who need easy access to safe and effective contraception.”

The FDA doesn’t have to follow its advisers’ advice, but it often does. It is expected to decide whether to approve the over-the-counter pill this summer.

If it’s approved, this will be the first birth-control pill available over the counter in the United States. Opill is a “mini-pill” that uses only the hormone progestin.

At Wednesday’s meeting, Dr. Margery Gass of the University of Cincinnati College of Medicine thanked the FDA for its consideration of switching Opill to an over-the-counter product.

“I think this represents a landmark in our history of women’s health. Unwanted pregnancies can really derail a woman’s life, and especially an adolescent’s life,” she said.

The FDA has faced pressure to allow Opill to go over-the-counter from lawmakers as well as health care providers.

Unwanted pregnancies are a public health issue in the US, where almost half of all pregnancies are unintended, and rates are especially high among lower-income women, Black women and those who haven’t completed high school.

In March 2022, 59 members of Congress wrote a letter to FDA Commissioner Dr. Robert Califf about OTC contraception.

“This is a critical issue for reproductive health, rights, and justice. Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system,” the lawmakers wrote.

A recent study showed that it’s become harder for women to access reproductive health care services more broadly – such as routine screenings and birth control – in recent years.

About 45% of women experienced at least one barrier to reproductive health care services in 2021, up 10% from 2017. Nearly 19% reported at least three barriers in 2021, up from 16% in 2017.

Increasing reproductive access for women and adolescents was a resounding theme among the FDA advisers.

“We can take this opportunity to increase access, reduce disparities and, most importantly, increase the reproductive autonomy of the women of our nation,” said Dr. Jolie Haun of the James A. Haley Veterans’ Hospital and the University of Utah.

Dr. Karen Murray, deputy director of the FDA’s Office of Nonprescription Drugs, said the agency understands the importance of “increased access to effective contraception” but hinted that the FDA would need more data from the manufacturer.

Some of the advisers and FDA scientists expressed concern that some of Perrigo’s data was unreliable due to overreporting of “improbable dosing.”

Murray said the lack of sufficient information from the study poses challenges for approval.

“It would have been a much easier time for the agency if the applicant had submitted a development program and an actual use study that was very easy to interpret and did not have so many challenges. But that was not what happened for us. And so the FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively in the nonprescription setting,” she said. “But I wanted to again emphasize that FDA does realize how very important women’s health is and how important it is to try to increase access to effective contraception for US women.”

Ultimately, the advisers said, they don’t want further studies of Opill to delay the availability of the product in an over-the-counter setting.

“I just wanted to say that the improbable dosing issue is important, and I don’t think it’s been adequately addressed and certainly leads to some uncertainty in the findings. But despite this, I would not recommend another actual use study this time, and I think we can make a decision on the totality of the evidence,” said Kate Curtis of the US Centers for Disease Control and Prevention.

Curtis said she voted yes because “Opill has the potential to have a huge positive public health impact.”

Earlier in the discussion, Dr. Leslie Walker-Harding of the University of Washington and Seattle Children’s Hospital said the pill is just as safe as many other medications available on store shelves.

“The safety profile is so good that we would need to take every other medicine off the market like Benadryl, ibuprofen, Tylenol, which causes deaths and people can get any amount of that without any oversight. And this is extremely safe, much safer than all three of those medications, and incorrect use still doesn’t appear to have problematic issues,” she said.

Dr. Katalin Roth of the George Washington University School of Medicine and Health Sciences also emphasized the safety of the pill over the 50 years it has been approved as a prescription drug in the US.

“The risks to women of an unintended pregnancy are much greater than any of the things we were discussing as risks of putting this pill out out over-the-counter,” she said. “The history of women’s contraception is a struggle for women’s control over their reproduction, and we need to trust women.”

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Bacterial infection linked to recent baby formula shortage may join federal disease watchlist | CNN

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US health officials may soon ask states to notify them of any cases of infants with serious infections caused by Cronobacter sakazakii, bacteria that can contaminate infant formula.

Cronobacter infections typically strike infants who are less than 2 months old, and they can be fatal or permanently disabling.

In an outbreak that the US Centers for Disease Control and Prevention investigated last year, four babies were sickened, including two who died. All the infants had been fed baby formula manufactured at the same factory in Sturgis, Michigan, triggering an extensive investigation by the US Food and Drug Administration and ultimately stopping production at the facility for months. The shutdown worsened ongoing supply chain issues and threw the country into a nationwide shortage.

Ultimately, the FDA and the CDC could find no genetic links between Cronobacter samples from the facility and the bacteria found in the water and powder used to mix the formula that the infants had consumed.

These infections are thought to be infrequent, but the true burden in the US is unknown because Cronobacter is not currently part of the National Notifiable Diseases Surveillance System, a list of about 120 illnesses given special priority by the CDC because they’ve been deemed to be important to public health.

The Council of State and Territorial Epidemiologists, a nonprofit organization that advocates for effective disease surveillance, identified Cronobacter as a priority area for investigation this year.

A work group was formed in the winter to assess conditions, risks and surveillance processes related to the bacterial infection, and it will present recommendations to advance Cronobacter surveillance in June.

Adding Cronobacter infections to the national watchlist is among the strategies being considered.

“When we look back at large-scale outbreaks over the course of the last year, many of those outbreaks were associated with diseases and conditions that were nationally notifiable, but not all of them,” said Janet Hamilton, executive director of the council – and Cronobacter was one of the exceptions.

“So whenever we have something like that, that prompts the council to determine and assess whether we need to potentially be doing more.”

Adding an illness to the national list can have a sizable impact. After E. coli O157 was added to the notifiable disease list in 1994 and most states required doctors to report cases by 2000, the number of reported outbreaks tripled.

However, it would take quite some time for any changes to take effect.

If the Council of State and Territorial Epidemiologists votes in favor of adding Cronobacter infections to the national list of notifiable diseases, the recommendation will go to the CDC for approval. If the CDC deems an illness to be notifiable, it’s up to state and local governments to adjust their reporting laws and develop processes for doctors to report cases to health departments, which then forward those reports to the CDC.

The soonest that data collection could start is the beginning of 2024, and it would most likely be well into the year, depending on state legislative sessions.

Currently, only two states, Minnesota and Michigan, require doctors to report Cronobacter cases, which may be diagnosed more generically as sepsis or meningitis, conditions that can result from an infection.

“Unless detailed studies are done, the diagnosis as a Cronobacter illness may be missed,” FDA Commissioner Dr. Robert Califf wrote in a blog post last week. “The lack of mandatory reporting significantly hampers the ability to fully understand Cronobacter’s public health impact.”

Dr. Peter Lurie, executive director of the Center for Science in the Public Interest, applauded the potential move.

“I think it’s a necessary step. It is difficult to prevent diseases that you can’t count,” Lurie said.

In addition, Lurie says, manufacturers should be required to notify the FDA when a batch of baby formula tests positive for Cronobacter before it leaves the plant. The FDA has asked manufacturers to tell it about positive tests, but such reporting is voluntary.

Lurie says the FDA should also be doing more sampling and testing for Cronobacter in the environment to get a better understanding of where the bacteria can turn up.

“I think we have a lot to learn there,” he said.

Mitzi Baum, CEO of the group Stop Foodborne Illness, which has been advocating for the change, said she was grateful the Council of State and Territorial Epidemiologists was moving toward a vote on it.

She said greater awareness of the infection was long overdue.

“It’s always prefaced by ‘this is rare,’ but we don’t know how rare it is because it’s not reportable. And there needs to be a lot more education about this pathogen and a lot more research,” Baum said.

Baum said her group is working with the council to create an education campaign to raise awareness of the infection among doctors. The next step, she says, is getting funding.

The council’s Hamilton points out that “simply making something nationally notifiable doesn’t necessarily translate into awareness and recognition on the prevention side. If people don’t have the right set of information and education, by the time we’re doing public health surveillance for it, the disease or infection has already occurred.”

According to the FDA, Cronobacter sakazakii is a common natural pathogen that can enter homes and other spaces on hands, shoes and other contaminated surfaces. It is “especially good at surviving in dry foods,” such as powdered baby formula.

Infections are harmless for most people, but it can be life-threatening for infants, especially those who are born prematurely or with weakened immune systems. It’s particularly important to be sure that parents of high-risk infants know how to keep them safe, Hamilton said.

“Providing good education around how to stop infections is really what leads to the level of change that we would love to see,” she said.

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