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



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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Using melatonin for sleep is on the rise, study says, despite potential health harms | CNN

Editor’s Note: Sign up for the Sleep, But Better newsletter series. Our seven-part guide has helpful hints to achieve better sleep.



CNN
 — 

More and more adults are taking over-the-counter melatonin to get to sleep, and some may be using it at dangerously high levels, a study has found.

The overall use among the US adult population is still “relatively low,” but the study does “document a significant many-fold increase in melatonin use in the past few years,” said sleep specialist Rebecca Robbins, an instructor in the division of sleep medicine for Harvard Medical School. She was not involved in the study.

The study, published in the medical journal JAMA, found that by 2018 Americans were taking more than twice the amount of melatonin than a decade earlier.

Melatonin has been linked to headaches, dizziness, nausea, stomach cramps, drowsiness, confusion or disorientation, irritability and mild anxiety, depression and tremors as well as abnormally low blood pressure. It can also interact with common medications and trigger allergies.

While short-term use for people with jet lag, shift workers and those who have trouble falling asleep appears to be safe, long-term safety is unknown, according to the National Center for Complementary and Integrative Health at the National Institutes of Health.

“In an associational study we found that older adults who reported frequent use — every night or most nights — of a sleep aid (over the counter or prescription) had a higher risk of incident dementia and early mortality,” Robbins said.

However, researchers could not determine which type of sleep aid — over-the-counter medications, such as melatonin, or prescription medications — was responsible for the findings.

Since 2006, a small but growing subset of adults are taking amounts of melatonin that far exceed the dosage of 5 milligrams a day typically used as a short-term treatment, the study found.

However, pills for sale may contain levels of melatonin much higher than what is advertised on the label. Unlike drugs and food, melatonin is not fully regulated by the US Food and Drug Administration, so there are no federal requirements that companies test pills to ensure they contain the amount of advertised melatonin.

“Previous research has found that that melatonin content in these unregulated, commercially available melatonin supplements ranged from — 83% to +478% of the labeled content,” said Robbins, who coauthored the book “Sleep for Success! Everything You Must Know About Sleep But are Too Tired to Ask.”

Nor are there any requirements that companies test their products for harmful hidden additives in melatonin supplements sold in stores and online. Previous studies also found 26% of the melatonin supplements contained serotonin, “a hormone that can have harmful effects even at relatively low levels,” according to the National Center for Complementary and Integrative Health.

“We cannot be certain of the purity of melatonin that is available over the counter,” Robbins said.

Taking too much serotonin by combining medications such as antidepressants, migraine medications and melatonin can lead to a serious drug reaction. Mild symptoms include shivering and diarrhea, while a more severe reaction can lead to muscle rigidity, fever, seizures and even death if not treated.

Because it is purchased over the counter, experts say many people view melatonin as an herbal supplement or vitamin. In reality, melatonin is a hormone made by the pineal gland, located deep within the brain, and released into the bloodstream to regulate the body’s sleep cycles.

“There is a view that if it’s natural, then it can’t hurt,” Robbins told CNN in an earlier interview on the impact of melatonin on children. “The truth is, we just really don’t know the implications of melatonin in the longer term, for adults or kids.”

Another reality: Studies have found that while using melatonin can be helpful in inducing sleep if used correctly — taking it at least two hours before bed — but the actual benefit is small.

“When adults took melatonin, it decreased the amount of time it took them to fall asleep by four to eight minutes,” Dr. Cora Collette Breuner, a professor in the department of pediatrics at Seattle Children’s Hospital at the University of Washington, told CNN in 2021.

“So for someone who takes hours to fall asleep, probably the better thing for them to do is turn off their screens, or get 20 to 40 minutes of exercise each day, or don’t drink any caffeinated products at all,” Breuner said.

“These are all sleep hygiene tools that work, but people are very reticent to do them. They rather just take a pill, right?”

There are other proven sleep tips that work just as well, if not better than sleeping aids, experts say. The body begins secreting melatonin at dark. What do we do in our modern culture? Use artificial light to keep us awake, often long past the body’s normal bedtime.

Research has found that the body will slow or stop melatonin production if exposed to light, including the blue light from our smartphones, laptops and the like.

“Any LED spectrum light source may further suppress melatonin levels,” said Dr. Vsevolod Polotsky, who directs sleep basic research in the division of pulmonary and critical care medicine at Johns Hopkins University School of Medicine, in an earlier CNN interview.

So ban those devices at least an hour before you want to fall asleep. Like to read yourself to sleep? That’s fine, experts say, just read in a dim light from a book or use an e-reader in night mode.

“Digital light will suppress the circadian drive,” Polotsky said, while a “dim reading light will not.”

Other tips include keeping your bedroom temperature at cooler temperatures — about 60 to 67 degrees Fahrenheit (15 to 20 degrees Celsius). We sleep better if we’re a bit chilly, experts say.

Set up a bedtime ritual by taking a warm bath or shower, reading a book or listening to soothing music. Or you can try deep breathing, yoga, meditation or light stretches. Go to bed and get up at the same time each day, even on weekends or your days off, experts say. The body likes routine.

If your doctor does prescribe melatonin to help with jet lag or other minor sleep issues, keep the use “short term,” Robbins said.

If you are planning to use melatonin for a short-term sleep aid, try to purchase pharmaceutical grade melatonin, she advised. To find it, look for a stamp showing that the independent, nonprofit US Pharmacopoeial Convention Dietary Supplement Verification Program has tested the product.

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Vaccines Fast Facts | CNN



CNN
 — 

Here’s a look at information and statistics concerning vaccines in the United States. For vaccines related to coronavirus, see Coronavirus Outbreak Timeline Fast Facts.

The Centers for Disease Control and Prevention (CDC) provides vaccine recommendations by age, as well as by disease.

For more than 100 years, there has been public discord regarding vaccines based on issues like individual rights, religious freedoms, distrust of government and the effects that vaccines may have on the health of children.

Exemptions to vaccines fall into three general categories: medical, religious and philosophical.

As of May 25, 2022, 44 states and the District of Columbia have enacted legislation allowing religious exemptions from vaccines, and 15 states allow philosophical (non-spiritual) exemptions.

1796 – Edward Jenner develops the smallpox vaccine, the world’s first successful vaccine.

1855 – Massachusetts mandates that school children are to be vaccinated (only the smallpox vaccine is available at the time).

February 20, 1905 – In Jacobson v. Massachusetts, the US Supreme Court upholds the State’s right to compel immunizing against smallpox.

November 13, 1922 – The US Supreme Court denies any constitutional violation in Zucht v. King in which Rosalyn Zucht believes that requiring vaccines violates her right to liberty without due process. The High Court opines that city ordinances that require vaccinations for children to attend school are a “discretion required for the protection of the public health.”

1952 – Dr. Jonas Salk and his team develop a vaccine for polio. A nationwide trial leads to the vaccine being declared in 1955 to be safe and effective.

1963 – The first measles vaccine is released. In 2000, the CDC declares the US has achieved measles elimination, defined as “the absence of continuous disease transmission for 12 months or more in a specific geographic area.” While the US has maintained measles elimination since, there are occasional outbreaks.

1986 – Congress passes the National Childhood Vaccine Injury Act. This coordinates vaccine activities across several government agencies to monitor vaccine safety, requires vaccine information statements are provided to those receiving vaccines, and creates the National Vaccine Injury Compensation Program to compensate those injured by vaccines on a “no fault” basis.

March 19, 1992 – Rolling Stone publishes an article by Tom Curtis, “The Origin of AIDS,” which presents a theory that ties HIV/AIDS to polio vaccines. Curtis writes that in the late 1950s, during a vaccination campaign in Africa, at least 325,000 people were immunized with a contaminated polio vaccine. The article alleges that the vaccine may have been contaminated with a monkey virus and is the cause of the human immunodeficiency virus, later known as HIV/AIDS.

August 10, 1993 – Congress passes the Omnibus Budget Reconciliation Act which creates the Vaccines for Children Program, providing qualified children free vaccines.

December 9, 1993 – Rolling Stone publishes an update to the Curtis article, clarifying that his theory was not fact, and Rolling Stone did not mean to suggest there was any scientific proof to support it, and the magazine regrets any damage caused by the article.

1998 – British researcher Andrew Wakefield and 12 other authors publish a paper stating they had evidence that linked the vaccination for Measles, Mumps and Rubella (MMR) to autism. They claim they discovered the measles virus in the digestive systems of autistic children who were given the measles, mumps and rubella (MMR) vaccine. The publication leads to a widespread increase in the number of parents choosing not to vaccinate their children for fear of its link to autism.

2004 – Co-authors of the Wakefield study begin removing their names from the article when they discover Wakefield had been paid by lawyers representing parents who planned to sue vaccine manufacturers.

May 14, 2004 – The Institute of Medicine releases a report “rejecting a causal relationship between the MMR vaccine and autism.”

February 2010 – The Lancet, the British medical journal that published Wakefield’s study, officially retracts the article. Britain also revokes Wakefield’s medical license.

2011 – Investigative reporter Brian Deer writes a series of articles in the BMJ exposing Wakefield’s fraud. The articles state that he used distorted data and falsified medical histories of children that may have led to an unfounded relationship between vaccines and the development of autism.

2011 – The US Public Health Service finds that 63% of parents who refuse and delay vaccines do so for fear their children could have serious side effects.

June 17, 2014 – After analyzing 10 studies, all of which looked at whether there was a link between vaccines and autism and involved a total of over one million children, the University of Sydney publishes a report saying there is no correlation between vaccinations and the development of autism.

February 2015 – Advocacy group Autism Speaks releases a statement, “Over the last two decades, extensive research has asked whether there is any link between childhood vaccinations and autism. The results of this research are clear: Vaccines do not cause autism. We urge that all children be fully vaccinated.

August 23, 2018 – A study published in the American Journal of Public Health finds that Twitter accounts run by automated bots and Russian trolls masqueraded as legitimate users engaging in online vaccine debates. The bots and trolls posted a variety of anti-, pro- and neutral tweets and directly confronted vaccine skeptics, which “legitimize” the vaccine debate, according to the researchers.

October 11, 2018 – Two reports published by the CDC find that vaccine exemption rates and the percentage of unvaccinated children are on the rise.

January 2019 – The World Health Organization names vaccine hesitancy as one of 10 threats to global health in 2019.

September 4, 2019 – Facebook announces that educational pop-up windows will appear on the social media platforms when a user searches for vaccine-related content, visits vaccine-related Facebook groups and pages, or taps a vaccine-related hashtag on Instagram

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.

December 27, 2019 – A study published in the medical journal JAMA Network Open finds that a single dose of the human papillomavirus (HPV) vaccine may be just as effective as two or three doses at preventing cancer-causing HPV infection.

February 3, 2020 – The National Institute of Allergy and Infectious Diseases (NIAID) announces that a clinical trial for an HIV vaccine has been discontinued since the vaccine was not found to prevent infections of human immunodeficiency virus, the virus that causes AIDS.

May 3, 2023 – The US FDA approves, Arexvy, the first vaccine to protect against respiratory syncytial virus or RSV. It is a single shot for adults 60 or older.

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Don’t use sugar substitutes for weight loss, World Health Organization advises | CNN



CNN
 — 

Don’t use sugar substitutes if you are trying to lose weight, according to new guidance from the World Health Organization.

The global health body said a systematic review of the available evidence suggests the use of non-sugar sweeteners, or NSS, “does not confer any long-term benefit in reducing body fat in adults or children.”

“Replacing free sugars with non-sugar sweeteners does not help people control their weight long-term,” said Francesco Branca, director of WHO’s department of nutrition and food safety. “We did see a mild reduction of body weight in the short term, but it’s not going to be sustained.”

The guidance applies to all people except those with preexisting diabetes, Branca said. Why? Simply because none of the studies in the review included people with diabetes, and an assessment could not be made, he said.

The review also indicated that there might be “potential undesirable effects” from the long-term use of sugar substitutes such as a mildly increased risk of type 2 diabetes and cardiovascular diseases.

However, “this recommendation is not meant to comment on safety of consumption,” Branca said. “What this guideline says is that if we’re looking for reduction of obesity, weight control or risk of noncommunicable diseases, that is unfortunately something science been unable to demonstrate,” he said. “It’s not going to produce the positive health effects that some people might be looking for.”

Non-sugar sweeteners are widely used as an ingredient in prepackaged foods and beverages and are also sometimes added to food and drinks directly by consumers. WHO issued guidelines on sugar intake in 2015, recommending that adults and children reduce their daily intake of free sugars to less than 10% of their total energy intake. Following that recommendation, interest in sugar alternatives intensified, the review said.

“This new guideline is based on a thorough assessment of the latest scientific literature, and it emphasises that the use of artificial sweeteners is not a good strategy for achieving weight loss by reducing dietary energy intake,” said nutrition researcher Ian Johnson, emeritus fellow at Quadram Institute Bioscience, formerly the Institute of Food Research, in Norwich, United Kingdom.

“However, this should not be interpreted as an indication that sugar intake has no relevance to weight-control,” Johnson said in a statement.

Instead, one should cut back on using sugar-sweetened drinks, and try to use “raw or lightly processed fruit as a source of sweetness,” Johnson added.

Dr. Keith Ayoob, scientific adviser for the Calorie Control Council, an international association representing the low-calorie food and beverage industry, told CNN via email the WHO’s “insistence on focusing only on prevention of unhealthy ‎weight gain and non-communicable diseases is at the very least, misguided.”

Robert Rankin, president of the Calorie Control Council, said “low- and no-calorie sweeteners are a critical tool that can help consumers manage body weight and reduce the risk of non-communicable diseases.”

The guidance is meant for government health organizations in countries who may wish to use the scientific analysis to implement policy changes for their citizens, Branca said.

“That will likely depend on the way that which sweeteners are consumed in a specific country,” he said. “For example, in a country where consumption patterns are high, those countries might decide to take action in a way or another.”

A total of 283 studies were included in the review. Both randomized controlled trials, considered the gold standard of research, and observational studies were included. Observational studies can only show an association, not direct cause and effect.

Results from randomized trials found the use of non-sugar sweeteners had a “low” impact on reducing body weight and calorie intake when compared with sugar, and no change in Intermediate markers of diabetes such as glucose and insulin, according to the report.

Observational studies also found a low impact on body weight and fat tissue, but no change in calorie intake. However, those studies found a low increase in risk for type 2 diabetes, high blood pressure, stroke, heart disease and death from heart disease, the report noted. A very low risk was also found for bladder cancer and an early death from any cause.

WHO said that the recommendation was “conditional” because the identified link between sweeteners and disease outcomes might be confounded by complicated patterns of sweetener use and the characteristics of the study participants.

In an emailed statement, the International Sweeteners Association, an industry assocation, said “it is a disservice to not recognise the public health benefits of low/no calorie sweeteners and is disappointed that the WHO’s conclusions are largely based on low certainty evidence from observational studies, which are at high risk of reverse causality.”

However, observational studies that follow people over time are important, Branca said. “To show that overweight people can reduce their body weight requires a long-term study. And we’re not seeing that impact from the research we have.”

The recommendation included low or no calorie synthetic sweeteners and natural extracts, which may or may not be chemically modified, such as acesulfame K, aspartame, advantame, cyclamates, neotame, saccharin, sucralose, stevia and stevia derivatives and monkfruit, the report said.

“Stevia and monkfruit are newer sweeteners so so there’s less published research in the scientific literature,” Branca said. “However they probably work in the body with a similar physiological mechanism as other sweeteners. We cannot say they are different from the others based on the data we have — they play the same role.”

Many people consider stevia products to be more “natural,” since they are derived from the stevia plant. Some natural and artificial sweeteners add bulking sugars to their products to cut their sweetness and add bulk to the product for baking.

A recent study by researchers at the US-based Cleveland Clinic found erythritol — used to add bulk or sweeten stevia, monkfruit and keto reduced-sugar products — was linked to blood clotting, stroke, heart attack and early death.

People with existing risk factors for heart disease, such as diabetes, were twice as likely to experience a heart attack or stroke if they had the highest levels of erythritol in their blood, the study found.

Just as many people have learned to eat and cook without salt, they can learn to reduce their dependence on free sugars and non-nutritive sweetners, Branca said.

“We need to target children in early life,” he said. “For example, why do parents typically use sweeteners as a reward for children and after almost every meal? We need to recommend to parents to avoid building that sweetness Interest in young children — that’s a very important action to take.”

Even if you are a true sugar “addict,” the good news is that you can tame your sweet tooth, registered dietitian Lisa Drayer said in an article for CNN. She provides the following steps:

Train your taste buds. If you gradually cut back on sugar — including artificial sweeteners — and include more protein and fiber-rich foods in your diet, that can help you crave less sugar, Drayer said.

“When we consume protein and fiber, it slows the rise in blood sugar if we consume it with a sugar-containing food. It can help satisfy us and help us reduce our sugar intake as well,” she said in a previous interview.

Choose no-sugar-added foods and avoid all sugar-sweetened drinks. For example, choose whole-grain cereal or Greek yogurt with no sweeteners. The sugar-sweetened drinks to take off your grocery list should include sodas, energy drinks, sports drinks and fruit punch. Choose water instead.

“If you like sweet carbonated beverages, add a splash of cranberry or orange juice to seltzer or try flavored seltzers. You can also flavor your own waters with fruit slices for natural sweetness or try herbal fruit teas,” Drayer said.

Drink coffee and tea with no or fewer sugars. Be careful at coffee shops, Drayer suggested. All those lattes and flavored coffees can have as much sugar as a can of soda, or more.

Enjoy fruit for dessert. Try cinnamon baked apples, berries or grilled peaches instead of cookies, cake, ice cream, pastries and other sweet treats, Drayer said.

Watch for stealth sugars. Added sugars are often present in foods that you might not think of as “sweet,” like sauces, breads, condiments and salad dressings, Drayer said.

“Pre-packaged sauces — like ketchup, BBQ sauce and tomato sauce — tend to be some of the biggest offenders of hidden added sugars in the diet,” Kristi King, senior pediatric dietitian at Texas Children’s Hospital and a national spokesperson for the Academy of Nutrition and Dietetics, told Drayer in a prior interview.

Check nutrition facts labels. All foods and beverages must list the amount and kind of sugar on the label.

Added sugars can go by other names such as “agave, brown sugar, corn sweetener, corn syrup, dextrose, evaporated cane juice, fructose, fruit juice concentrate, fruit nectar, glucose, high-fructose corn syrup, honey, invert sugar, lactose, malt syrup, maltose, molasses, maple syrups, raw sugar, sucrose, trehalose and turbinado sugar,” Drayer said.

The higher up these added sugars are on the ingredients list, the greater the amount of added sugar in the product, she said.

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



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



CNN
 — 

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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Covid-19 Pandemic Timeline Fast Facts | CNN



CNN
 — 

Here’s a look at the coronavirus outbreak, declared a worldwide pandemic by the World Health Organization. The coronavirus, called Covid-19 by WHO, originated in China and is the cousin of the SARS virus.

Coronaviruses are a large group of viruses that are common among animals. The viruses can make people sick, usually with a mild to moderate upper respiratory tract illness, similar to a common cold. Coronavirus symptoms include a runny nose, cough, sore throat, possibly a headache and maybe a fever, which can last for a couple of days.

WHO Situation Reports

Coronavirus Map

CNN’s early reporting on the coronavirus

December 31, 2019 – Cases of pneumonia detected in Wuhan, China, are first reported to WHO. During this reported period, the virus is unknown. The cases occur between December 12 and December 29, according to Wuhan Municipal Health.

January 1, 2020 – Chinese health authorities close the Huanan Seafood Wholesale Market after it is discovered that wild animals sold there may be the source of the virus.

January 5, 2020 – China announces that the unknown pneumonia cases in Wuhan are not SARS or MERS. In a statement, the Wuhan Municipal Health Commission says a retrospective probe into the outbreak has been initiated.

January 7, 2020 – Chinese authorities confirm that they have identified the virus as a novel coronavirus, initially named 2019-nCoV by WHO.

January 11, 2020 – The Wuhan Municipal Health Commission announces the first death caused by the coronavirus. A 61-year-old man, exposed to the virus at the seafood market, died on January 9 after respiratory failure caused by severe pneumonia.

January 17, 2020 – Chinese health officials confirm that a second person has died in China. The United States responds to the outbreak by implementing screenings for symptoms at airports in San Francisco, New York and Los Angeles.

January 20, 2020 – China reports 139 new cases of the sickness, including a third death. On the same day, WHO’s first situation report confirms cases in Japan, South Korea and Thailand.

January 20, 2020 – The National Institutes of Health announces that it is working on a vaccine against the coronavirus. “The NIH is in the process of taking the first steps towards the development of a vaccine,” says Dr. Anthony Fauci, director of the National Institutes of Allergy and Infectious Diseases.

January 21, 2020 – Officials in Washington state confirm the first case on US soil.

January 23, 2020 – At an emergency committee, WHO says that the coronavirus does not yet constitute a public health emergency of international concern.

January 23, 2020 – The Beijing Culture and Tourism Bureau cancels all large-scale Lunar New Year celebrations in an effort to contain the growing spread of coronavirus. On the same day, Chinese authorities enforce a partial lockdown of transport in and out of Wuhan. Authorities in the nearby cities of Huanggang and Ezhou Huanggang announce a series of similar measures.

January 28, 2020 – Chinese President Xi Jinping meets with WHO Director General Tedros Adhanom in Beijing. At the meeting, Xi and WHO agree to send a team of international experts, including US Centers for Disease Control and Prevention staff, to China to investigate the coronavirus outbreak.

January 29, 2020 – The White House announces the formation of a new task force that will help monitor and contain the spread of the virus, and ensure Americans have accurate and up-to-date health and travel information, it says.

January 30, 2020 – The United States reports its first confirmed case of person-to-person transmission of the coronavirus. On the same day, WHO determines that the outbreak constitutes a Public Health Emergency of International Concern (PHEIC).

January 31, 2020 – The Donald Trump administration announces it will deny entry to foreign nationals who have traveled in China in the last 14 days.

February 2, 2020 – A man in the Philippines dies from the coronavirus – the first time a death has been reported outside mainland China since the outbreak began.

February 3, 2020 – China’s Foreign Ministry accuses the US government of inappropriately reacting to the outbreak and spreading fear by enforcing travel restrictions.

February 4, 2020 – The Japanese Health Ministry announces that ten people aboard the Diamond Princess cruise ship moored in Yokohama Bay are confirmed to have the coronavirus. The ship, which is carrying more than 3,700 people, is placed under quarantine scheduled to end on February 19.

February 6, 2020 – First Covid-19 death in the United States: A person in California’s Santa Clara County dies of coronavirus, but the link is not confirmed until April 21.

February 7, 2020 – Li Wenliang, a Wuhan doctor who was targeted by police for trying to sound the alarm on a “SARS-like” virus in December, dies of the coronavirus. Following news of Li’s death, the topics “Wuhan government owes Dr. Li Wenliang an apology,” and “We want freedom of speech,” trend on China’s Twitter-like platform, Weibo, before disappearing from the heavily censored platform.

February 8, 2020 – The US Embassy in Beijing confirms that a 60-year-old US national died in Wuhan on February 6, marking the first confirmed death of a foreigner.

February 10, 2020 – Xi inspects efforts to contain the coronavirus in Beijing, the first time he has appeared on the front lines of the fight against the outbreak. On the same day, a team of international experts from WHO arrive in China to assist with containing the coronavirus outbreak.

February 10, 2020 – The Anthem of the Seas, a Royal Caribbean cruise ship, sets sail from Bayonne, New Jersey, after a coronavirus scare had kept it docked and its passengers waiting for days.

February 11, 2020 – WHO names the coronavirus Covid-19.

February 13, 2020 – China’s state-run Xinhua News Agency announces that Shanghai mayor Ying Yong will be replacing Jiang Chaoliang amid the outbreak. Wuhan Communist Party chief Ma Guoqiang has also been replaced by Wang Zhonglin, party chief of Jinan city in Shandong province, according to Xinhua.

February 14, 2020 – A Chinese tourist who tested positive for the virus dies in France, becoming the first person to die in the outbreak in Europe. On the same day, Egypt announces its first case of coronavirus, marking the first case in Africa.

February 15, 2020 – The official Communist Party journal Qiushi publishes the transcript of a speech made on February 3 by Xi in which he “issued requirements for the prevention and control of the new coronavirus” on January 7, revealing Xi knew about and was directing the response to the virus on almost two weeks before he commented on it publicly.

February 17, 2020 – A second person in California’s Santa Clara County dies of coronavirus, but the link is not confirmed until April 21.

February 18, 2020 – Xi says in a phone call with British Prime Minister Boris Johnson that China’s measures to prevent and control the epidemic “are achieving visible progress,” according to state news Xinhua.

February 21, 2020 – The CDC changes criteria for counting confirmed cases of novel coronavirus in the United States and begins tracking two separate and distinct groups: those repatriated by the US Department of State and those identified by the US public health network.

February 25, 2020 – The NIH announces that a clinical trial to evaluate the safety and effectiveness of the antiviral drug remdesivir in adults diagnosed with coronavirus has started at the University of Nebraska Medical Center in Omaha. The first participant is an American who was evacuated from the Diamond Princess cruise ship docked in Japan.

February 25, 2020 – In an effort to contain the largest outbreak in Europe, Italy’s Lombardy region press office issues a list of towns and villages that are in complete lockdown. Around 100,000 people are affected by the travel restrictions.

February 26, 2020 – CDC officials say that a California patient being treated for novel coronavirus is the first US case of unknown origin. The patient, who didn’t have any relevant travel history nor exposure to another known patient, is the first possible US case of “community spread.”

February 26, 2020 – Trump places Vice President Mike Pence in charge of the US government response to the novel coronavirus, amid growing criticism of the White House’s handling of the outbreak.

February 29, 2020 – A patient dies of coronavirus in Washington state. For almost two months, this is considered the first death due to the virus in the United States, until autopsy results announced April 21 reveal two earlier deaths in California.

March 3, 2020 – The Federal Reserve slashes interest rates by half a percentage point in an attempt to give the US economy a jolt in the face of concerns about the coronavirus outbreak. It is the first unscheduled, emergency rate cut since 2008, and it also marks the biggest one-time cut since then.

March 3, 2020 – Officials announce that Iran will temporarily release 54,000 people from prisons and deploy hundreds of thousands of health workers as officials announced a slew of measures to contain the world’s deadliest coronavirus outbreak outside China. It is also announced that 23 members of Iran’s parliament tested positive for the virus.

March 4, 2020 – The CDC formally removes earlier restrictions that limited coronavirus testing of the general public to people in the hospital, unless they had close contact with confirmed coronavirus cases. According to the CDC, clinicians should now “use their judgment to determine if a patient has signs and symptoms compatible with COVID-19 and whether the patient should be tested.”

March 8, 2020 – Italian Prime Minister Giuseppe Conte signs a decree placing travel restrictions on the entire Lombardy region and 14 other provinces, restricting the movements of more than 10 million people in the northern part of the country.

March 9, 2020 – Conte announces that the whole country of Italy is on lockdown.

March 11, 2020 – WHO declares the novel coronavirus outbreak to be a pandemic. WHO says the outbreak is the first pandemic caused by a coronavirus. In an Oval Office address, Trump announces that he is restricting travel from Europe to the United States for 30 days in an attempt to slow the spread of coronavirus. The ban, which applies to the 26 countries in the Schengen Area, applies only to foreign nationals and not American citizens and permanent residents who’d be screened before entering the country.

March 13, 2020 – Trump declares a national emergency to free up $50 billion in federal resources to combat coronavirus.

March 18, 2020 – Trump signs into law a coronavirus relief package that includes provisions for free testing for Covid-19 and paid emergency leave.

March 19, 2020 – At a news conference, officials from China’s National Health Commission report no new locally transmitted coronavirus cases for the first time since the pandemic began.

March 23, 2020 – United Nations Secretary-General António Guterres calls for an immediate global ceasefire amid the pandemic to fight “the common enemy.”

March 24, 2020 – Japan’s Prime Minister Shinzo Abe and International Olympic Committee (IOC) president Thomas Bach agree to postpone the Olympics until 2021 amid the outbreak.

March 25, 2020 – The White House and Senate leaders reach an agreement on a $2 trillion stimulus deal to offset the economic damage of coronavirus, producing one of the most expensive and far-reaching measures in the history of Congress.

March 27, 2020 – Trump signs the stimulus package into law.

April 2, 2020 – According to the Department of Labor, 6.6 million US workers file for their first week of unemployment benefits in the week ending March 28, the highest number of initial claims in history. Globally, the total number of coronavirus cases surpasses 1 million, according to Johns Hopkins University’s tally.

April 3, 2020 – Trump says his administration is now recommending Americans wear “non-medical cloth” face coverings, a reversal of previous guidance that suggested masks were unnecessary for people who weren’t sick.

April 8, 2020 – China reopens Wuhan after a 76-day lockdown.

April 14, 2020 – Trump announces he is halting funding to WHO while a review is conducted, saying the review will cover WHO’s “role in severely mismanaging and covering up the spread of coronavirus.”

April 20, 2020 – Chilean health officials announce that Chile will begin issuing the world’s first digital immunity cards to people who have recovered from coronavirus, saying the cards will help identify individuals who no longer pose a health risk to others.

April 21, 2020 – California’s Santa Clara County announces autopsy results that show two Californians died of novel coronavirus in early and mid-February – up to three weeks before the previously known first US death from the virus.

April 28, 2020 – The United States passes one million confirmed cases of the virus, according to Johns Hopkins.

May 1, 2020 – The US Food and Drug Administration issues an emergency-use authorization for remdesivir in hospitalized patients with severe Covid-19. FDA Commissioner Stephen Hahn says remdesivir is the first authorized therapy drug for Covid-19.

May 4, 2020 – During a virtual pledging conference co-hosted by the European Union, world leaders pledge a total of $8 billion for the development and deployment of diagnostics, treatments and vaccines against the novel coronavirus.

May 11, 2020 – Trump and his administration announce that the federal government is sending $11 billion to states to expand coronavirus testing capabilities. The relief package signed on April 24 includes $25 billion for testing, with $11 billion for states, localities, territories and tribes.

May 13, 2020 – Dr. Mike Ryan, executive director of WHO’s health emergencies program, warns that the coronavirus may never go away and may just join the mix of viruses that kill people around the world every year.

May 19, 2020 – WHO agrees to hold an inquiry into the global response to the coronavirus pandemic. WHO member states adopt the proposal with no objections during the World Health Assembly meeting, after the European Union and Australia led calls for an investigation.

May 23, 2020 – China reports no new symptomatic coronavirus cases, the first time since the beginning of the outbreak in December.

May 27, 2020 – Data collected by Johns Hopkins University reports that the coronavirus has killed more than 100,000 people across the US, meaning that an average of almost 900 Americans died each day since the first known coronavirus-related death was reported nearly four months earlier.

June 2, 2020 – Wuhan’s Health Commission announces that it has completed coronavirus tests on 9.9 million of its residents with no new confirmed cases found.

June 8, 2020 – New Zealand Prime Minister Jacinda Ardern announces that almost all coronavirus restrictions in New Zealand will be lifted after the country reported no active cases.

June 11, 2020 – The United States passes 2 million confirmed cases of the virus, according to Johns Hopkins.

June 16, 2020 – University of Oxford scientists leading the Recovery Trial, a large UK-based trial investigating potential Covid-19 treatments, announce that a low-dose regimen of dexamethasone for 10 days was found to reduce the risk of death by a third among hospitalized patients requiring ventilation in the trial.

June 20, 2020 – The NIH announces that it has halted a clinical trial evaluating the safety and effectiveness of drug hydroxychloroquine as a treatment for the coronavirus. “A data and safety monitoring board met late Friday and determined that while there was no harm, the study drug was very unlikely to be beneficial to hospitalized patients with Covid-19,” the NIH says in a statement.

June 26, 2020 – During a virtual media briefing, WHO announces that it plans to deliver about 2 billion doses of a coronavirus vaccine to people across the globe. One billion of those doses will be purchased for low- and middle-income countries, according to WHO.

July 1, 2020 – The European Union announces it will allow travelers from 14 countries outside the bloc to visit EU countries, months after it shut its external borders in response to the pandemic. The list does not include the US, which doesn’t meet the criteria set by the EU for it to be considered a “safe country.”

July 6, 2020 – In an open letter published in the journal Clinical Infectious Diseases, 239 scientists from around the world urge WHO and other health agencies to be more forthright in explaining the potential airborne transmission of coronavirus. In the letter, scientists write that studies “have demonstrated beyond any reasonable doubt that viruses are released during exhalation, talking, and coughing in microdroplets small enough to remain aloft in air and pose a risk of exposure at distances beyond 1 to 2 meters (yards) from an infected individual.”

July 7, 2020 – The Trump administration notifies Congress and the United Nations that the United States is formally withdrawing from WHO. The withdrawal goes into effect on July 6, 2021.

July 21, 2020 – European leaders agree to create a €750 billion ($858 billion) recovery fund to rebuild EU economies ravaged by the coronavirus.

July 27, 2020 – A vaccine being developed by the Vaccine Research Center at the National Institutes of Health’s National Institute of Allergy and Infectious Diseases, in partnership with the biotechnology company Moderna, enters Phase 3 testing. The trial is expected to enroll about 30,000 adult volunteers and evaluates the safety of the vaccine and whether it can prevent symptomatic Covid-19 after two doses, among other outcomes.

August 11, 2020 – In a live teleconference, Russian President Vladimir Putin announces that Russia has approved a coronavirus vaccine for public use before completion of Phase 3 trials, which usually precedes approval. The vaccine, which is named Sputnik-V, is developed by the Moscow-based Gamaleya Institute with funding from the Russian Direct Investment Fund (RDIF).

August 15, 2020 – Russia begins production on Sputnik-V, according to Russian state news agency TASS.

August 23, 2020 – The FDA issues an emergency use authorization for the use of convalescent plasma to treat Covid-19. It is made using the blood of people who have recovered from coronavirus infections.

August 27, 2020 – The CDC notifies public health officials around the United States to prepare to distribute a potential coronavirus vaccine as soon as late October. In the documents, posted by The New York Times, the CDC provides planning scenarios to help states prepare and advises on who should get vaccinated first – healthcare professionals, essential workers, national security “populations” and long-term care facility residents and staff.

September 4, 2020 – The first peer-reviewed results of Phase 1 and Phase 2 clinical trials of Russia’s Covid-19 vaccine are published in the medical journal The Lancet. The results “have a good safety profile” and the vaccine induced antibody responses in all participants, The Lancet says.

October 2, 2020 – Trump announces that he and first lady Melania Trump have tested positive for Covid-19. He spends three nights at Walter Reed National Military Medical Center receiving treatment before returning to the White House.

October 12, 2020 – Drugmaker Johnson & Johnson announces it has paused the advanced clinical trial of its experimental coronavirus vaccine because of an unexplained illness in one of the volunteers.”Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians,” the company said in a statement. ENSEMBLE is the name of the study. The trial resumes later in the month.

December 10, 2020 – Vaccine advisers to the FDA vote to recommend the agency grant emergency use authorization to Pfizer and BioNTech’s coronavirus vaccine.

December 14, 2020 – US officials announce the first doses of the FDA authorized Pfizer vaccine have been delivered to all 50 states, the District of Columbia and Puerto Rico.

December 18, 2020 – The FDA authorizes a second coronavirus vaccine made by Moderna for emergency use. “The emergency use authorization allows the vaccine to be distributed in the U.S. for use in individuals 18 years and older,” the FDA said in a tweet.

January 14, 2021 – The WHO team tasked with investigating the origins of the outbreak in Wuhan arrive in China.

January 20, 2021 – Newly elected US President Joe Biden halts the United States’ withdrawal from WHO.

February 22, 2021 – The death toll from Covid-19 exceeds 500,000 in the United States.

February 27, 2021 – The FDA grants emergency use authorization to Johnson & Johnson’s Covid-19 vaccine, the first single dose Covid-19 vaccine available in the US.

March 30, 2021 – According to a 120-page report from WHO, the novel coronavirus that causes Covid-19 probably spread to people through an animal, and probably started spreading among humans no more than a month or two before it was noticed in December of 2019. The report says a scenario where it spread via an intermediate animal host, possibly a wild animal captured and then raised on a farm, is “very likely.”

April 17, 2021 – The global tally of deaths from Covid-19 surpasses 3 million, according to data compiled by Johns Hopkins.

August 3, 2021 – According to figures published by the CDC, the more contagious Delta variant accounts for an estimated 93.4% of coronavirus circulating in the United States during the last two weeks of July. The figures show a rapid increase over the past two months, up from around 3% in the two weeks ending May 22.

August 12, 2021 – The FDA authorizes an additional Covid-19 vaccine dose for certain immunocompromised people.

August 23, 2021 – The FDA grants full approval to the Pfizer/BioNTech Covid-19 vaccine for people age 16 and older, making it the first coronavirus vaccine approved by the FDA.

September 24, 2021 CDC Director Dr. Rochelle Walensky diverges from the agency’s independent vaccine advisers to recommend boosters for a broader group of people – those ages 18 to 64 who are at increased risk of Covid-19 because of their workplaces or institutional settings – in addition to older adults, long-term care facility residents and some people with underlying health conditions.

November 2, 2021 – Walensky says she is endorsing a recommendation to vaccinate children ages 5-11 against Covid-19, clearing the way for immediate vaccination of the youngest age group yet in the US.

November 19, 2021 – The FDA authorizes boosters of the Pfizer/BioNTech and Moderna Covid-19 vaccines for all adults. The same day, the CDC also endorses boosters for all adults.

December 16, 2021 – The CDC changes its recommendations for Covid-19 vaccines to make clear that shots made by Moderna and Pfizer/BioNTech are preferred over Johnson & Johnson’s vaccine.

December 22, 2021 – The FDA authorizes Pfizer’s antiviral pill, Paxlovid, to treat Covid-19, the first antiviral Covid-19 pill authorized in the United States for ill people to take at home, before they get sick enough to be hospitalized. The following day, the FDA authorizes Merck’s antiviral pill, molnupiravir.

December 27, 2021 The CDC shortens the recommended times that people should isolate when they’ve tested positive for Covid-19 from 10 days to five days if they don’t have symptoms – and if they wear a mask around others for at least five more days. The CDC also shortens the recommended time for people to quarantine if they are exposed to the virus to a similar five days if they are vaccinated.

January 31, 2022 – The FDA grants full approval to Moderna’s Covid-19 vaccine for those ages 18 and older. This is the second coronavirus vaccine given full approval by the FDA.

March 29, 2022 – The FDA authorizes a second booster of the Pfizer/BioNTech and Moderna Covid-19 vaccines for adults 50 and older. That same day, the CDC also endorses a second booster for the same age group.

April 25, 2022 – The FDA expands approval of the drug remdesivir to treat patients as young as 28 days and weighing about seven pounds.

May 17, 2022 – The FDA authorizes a booster dose of Pfizer/BioNTech’s Covid-19 vaccine for children ages 5 to 11 at least five months after completion of the primary vaccine series. On May 19, the CDC also endorses a booster dose for the same age group.

June 18, 2022 – The CDC recommends Covid-19 vaccines for children as young as 6 months.

August 31, 2022 – The FDA authorizes updated Covid-19 vaccine booster shots from Moderna and Pfizer. Both are bivalent vaccines that combine the companies’ original vaccine with one that targets the BA.4 and BA.5 Omicron sublineages. The CDC signs off on the updated booster shots the following day.

May 5, 2023 – The WHO says Covid-19 is no longer a global health emergency.



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Chinese postpartum confinement, called ‘zuo yue zi,’ is gaining Western appeal | CNN


Hong Kong
CNN
 — 

You cannot carry heavy things. You should sleep more. No working. No household chores.

And the list goes on as Carol Chan explained her postpartum instructions for new mom Taylor Richard.

Chan is a “pui yuet,” also called a confinement nanny, who lives with families after a baby is born. She prepares meals and herbal medicines, takes care of the baby and provides guidance on being a new mother.

Richard, a content creator from Canada, traveled to Hong Kong to become a model and fell in love with her husband, Tom, there. They married in November 2018, and Richard gave birth to their son, Levi, in March 2022.

Richard decided to hire Chan, who lived with the family for a month and spent an additional month helping out.

Richard vlogged about her experience with Chan on her YouTube channel, and that video went viral with 2.9 million views. The reaction was mostly admiration and praise from Richard’s primarily Western followers.

The concept of Chinese confinement — “zuo yue zi,” or “sitting the month”— is when a new mother stays at home for one month to allow her body to rest after giving birth.

During that time, the pui yuet makes dishes catering to the mother’s physical needs and helps her with milk production and other concerns. The pui yuet also cares for the mother with massage, body wraps and lessons on how to take care of the new baby.

Richard and Chan declined to share the cost of Chan’s services. Few entities track the pricing of nannies in Hong Kong on a consistent basis because most negotiations are directly between clients and the nannies.

The estimated cost for a pui yuet in Hong Kong ranges from 63,800 Hong Kong dollars (US $8,100) to 268,000 Hong Kong dollars (US $34,100) for 26 to 30 nights for a live-in nanny, according to a 2021 survey by the Consumer Council, a statutory body in Hong Kong dedicated to protecting consumer rights. The council, which surveyed 19 companies or organizations that provide postnatal care, also reported that the cost of a pui yuet working eight hours a day for 26 days ranges from 21,000 Hong Kong dollars (US $2,600) to 34,000 Hong Kong dollars (US $4,300).

This tradition isn’t without criticism, and some have questioned whether the traditional methods of confinement in the Chinese community are too extreme and may be dangerous. In 2015, a new mother in Shanghai following the custom died of heatstroke after wrapping herself in a quilt and turning off the air conditioner, state media reported.

Chan has gotten calls from the US and UK to be a pui yuet after a YouTube video about her went viral.

In recent years, some people have adapted the tradition to more modern ways, taking advantage of available technology. It’s important to turn the air conditioner on when the weather is hot, Chan said, or else you could get sick. The traditional practice had been to avoid anything cold regardless of the weather.

Richard, now 34, said she loved the time she spent with Chan.

“It meant everything! My husband and I both don’t have any family members in Hong Kong, and as new parents we were pretty clueless,” she said via email. “Having someone take care of my body and gently guide me through my transition into motherhood made for a very positive beginning of my baby’s life. I’m forever grateful for Carol!”

Richard was the first Western mother whom Chan cared for in her 12-year career. But since Richard’s YouTube video went viral, Chan said she’s gotten calls from Westerners asking for her services from as far away as the United States and United Kingdom. She’s now headed to Vancouver, British Columbia, in July to work as a pui yuet for a family there for a month.

The kind of care Richard received is expensive, whether the new parents live in Hong Kong or elsewhere. One US location, Boram Postnatal Retreat, opened last year in New York City.

“It was very challenging to get the concept received by others,” cofounder Boram Nam told CNN. “It was a lot about the education process — information is abundant up to until you give birth, and the spotlight completely shifts over to the baby — so we get into that discussion, and people get it.”

Cofounder Boram Nam opened Boram Postnatal Retreat last year in New York for new mothers.

But her program comes with a hefty price tag, starting at three nights for $2700.

“This is the price we do need to charge for the level of service that we provide within the guidelines of what postpartum care looks like in the US,” said Nam, adding that she hopes eventually to get services covered by insurance. “We want to make sure this can be accessible by others, by more women, a more diverse group of people.”

Mandy Major, owner of Major Care, a virtual postpartum doula service based in the US, has noticed a lack of postpartum education in her country.

“We have a lack of systematic postpartum here within our health care system,” Major said. “We have a go-go, hyper-productive, hyper-independent culture, but we also don’t have paid leave.”

Richard’s mostly Western followers on YouTube noted that pressure, commenting on the luxury of taking a month off to spend time recovering and connecting with their babies.

“As an American woman who has given birth 4 times and been booted immediately out of the hospital expected to figure it all out on my own, I can undoubtedly say had this been an option, it may have changed my whole mothering experiences!!” one person said.

“I returned to work 2 weeks postpartum in America,” another mother wrote. “I never felt that I was able to fully bond with my child.”

The month of confinement came to an end for Richard last April. In Richard’s YouTube video, Chan holds Levi one last time and passes him back to his mother as she put her shoes on to leave.

Richard’s eyes begin to fill with tears, surprising herself at her emotional reaction.

“I feel like I’m losing a family member,” she says as the door slowly closes behind Chan, according to the video.

Even after the confinement experience, Chan remains close with Richard’s family, stopping by for lunch occasionally and still giving baby advice.

“If I have another baby, I would love to have it in Canada with my family, but I want Carol to come with me if I do!” Richard said in a video chat later, smiling. “I can’t imagine going through this again without her.”

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These women ran an underground abortion network in the 1960s. Here’s what they fear might happen today | CNN



CNN
 — 

The voice on the phone in 1966 was gruff and abrupt: “Do you want the Chevy, the Cadillac or the Rolls Royce?”

A Chevy abortion would cost about $200, cash in hand, the voice explained. A Cadillac was around $500, and the Rolls Royce was $1,000.

“You can’t afford more than the Chevy? Fine,” the voice growled. “Go to this address at this time. Don’t be late and don’t forget the cash.” The voice disappeared.

Dorie Barron told CNN she recalls staring blankly at the phone in her hand, startled by the sudden empty tone. Then it hit her: She had just arranged an illegal abortion with the Chicago Mafia.

The motel Barron was sent to was in an unfamiliar part of Chicago, a scary “middle of nowhere,” she said. She was told to go to a specific room, sit on the bed and wait. Suddenly three men and a woman came in the door.

“I was petrified. They spoke all of three sentences to me the entire time: ‘Where’s the money?’ ‘Lie back and do as I tell you.’ And finally ‘Get in the bathroom,’” when the abortion was over, Barron said. “Then all of a sudden they were gone.”

Bleeding profusely, Barron managed to find a cab to take her home. When the bleeding didn’t stop, her bed-ridden mother made her go to the hospital.

At 24, Barron was taking care of her ailing mother and her 2-year-old daughter when she discovered she was pregnant. Her boyfriend, who had no job and lived with his parents, “freaked,” said Barron, who appears in a recent HBO documentary. The boyfriend suggested she get an abortion. She had never considered that option.

“But what was I to do? My mom was taking care of my daughter from her bed while I worked — they would read and play games until I got home,” Barron said.”How was either of us going to cope with a baby?

“Looking back, I realize I was taking my life in my hands,” said Barron, now an 81-year-old grandmother. “To this day it gives me chills. If I had died, what in God’s green earth would have happened to my mom and daughter?”

Women in the 1960s endured restrictions relatively unknown to women today. The so-called “fairer sex” could not serve on juries and often could not get an Ivy League education. Women earned about half as much as a man doing the same job and were seldom promoted.

Women could not get a credit card unless they were married — and then only if their husband co-signed. The same applied to birth control — only the married need apply. More experienced women shared a workaround with the uninitiated: “Go to Woolworth, buy a cheap wedding-type ring and wear it to your doctor’s appointment. And don’t forget to smile.”

Marital rape wasn’t legally considered rape. And, of course, women had no legal right to terminate a pregnancy until four states — Alaska, Hawaii, New York and Washington — legalized abortion in 1970, three years before Roe v. Wade became the law of the land.

Illinois had no such protection, said Heather Booth, a lifelong feminist activist and political strategist: “Three people discussing having an abortion in Chicago in 1965 was a conspiracy to commit felony murder.”

Despite that danger, a courageous band of young women — most in their 20’s, some in college, some married with children — banded together in Chicago to create an underground abortion network. The group was officially created in 1969 as the “Abortion Counseling Service of Women’s Liberation.”

But after running ads in an underground newspaper: “Pregnant? Don’t want to be? Call Jane,” each member of the group answered the phone as “Jane.”

Despite their youth, members of Jane managed to run an illegal abortion service dedicated to each woman's needs.
From left: Martha Scott, Jeanne Galatzer-Levy, Abby Pariser, Sheila Smith and Madeline Schwenk.

“We were co-conspirators with the women who called us,” said 75-year-old Laura Kaplan, who published a book about the service in 1997 entitled “The Story of Jane: The Legendary Underground Feminist Abortion Service.”

“We’ll protect you; we hope you’ll protect us,” Kaplan said. “We’ll take care of you; we hope you’ll take care of us.”

What started as referrals to legitimate abortion providers changed to personalized service when some members of Jane learned to safely do the abortions themselves. Between the late 1960s and 1973, the year that the Supreme Court decided Roe v. Wade, Jane had arranged or performed over 11,000 abortions.

“Our culture is always searching for heroes,” said Kaplan. “But you don’t have to be a hero to do extraordinary things. Jane was just ordinary people working together — and look what we could accomplish, which is amazing, right?”

Even after several members were caught and arrested, the group continued to provide abortions for women too poor to travel to states where abortion had been legalized.

“I prayed a lot. I didn’t want to go to jail,” said 80-year-old Marie Learner, who allowed the Janes to perform abortions at her apartment.

“Some of us had little children. Some were the sole breadwinners in their home,” Learner said. “It was fearlessness in the face of overwhelming odds.”

Marie Learner opened her home to women undergoing abortions. Her neighbors knew, she said, but did not tell police.

The story of Jane has been immortalized in Kaplan’s book, numerous print articles, a 2022 movie, “Call Jane,” starring Elizabeth Banks and Sigourney Weaver, and a documentary on HBO (which, like CNN, is owned by Warner Bros. Discovery).

Today the historical tale of Jane has taken on a new significance. After the 2022 Supreme Court reversal of Roe v. Wade and the mid-term takeover of the US House of Representatives by Republicans, emboldened conservative lawmakers and judges have acted on their anti-abortion beliefs.

Currently more than a dozen states have banned or imposed severe restrictions on abortion. Georgia has banned abortions after six weeks, even though women are typically unaware they are pregnant at that stage. In mid-April, Florida Governor Ron DeSantis signed a bill that would ban most abortions after six weeks. It won’t go into effect until the state Supreme Court overturns its previous precedent on abortion. Several other states are considering similar legislation. In other states, judicial battles are underway to protect abortion access.

“It’s a horrific situation right now. People will be harmed, some may even die,” said Booth, who helped birth the Jane movement while in college.

“Women without family support, without the information they need, may be isolated and either harm themselves looking to end an unwanted pregnancy or will be harmed because they went to an unscrupulous and illegal provider,” said Booth, now 77.

A key difference between the 60s and today is medication abortion, which 54% of people in the United States used to end a pregnancy in 2022. Available via prescription and through the mail, use of the drugs is two-fold: A person takes a first pill, mifepristone, to block the hormone needed for a pregnancy to continue.  A day or two later, the patient takes a second drug, misoprostol, which causes the uterus to contract, creating the cramping and bleeding of labor.

In early April a Texas judge, US District Judge Matthew Kacsmaryk – a Trump appointee who has been vocal about his anti-abortion stance — suspended the US Food and Drug Administration’s approval of mifepristone despite 23 years of data showing the drug is safe to use, safer even than penicillin or Viagra.

On Friday, the Supreme Court froze the ruling and a subsequent decision by the Fifth US Circuit Court of Appeals at the request of the Justice Department and the drug manufacturer. The action allows access to mifepristone in states where it’s legal until appeals play out over the months to come.

However, 15 states currently restrict access to medication abortion, even by mail.

The actions of anti-abortion activists, who have been accused of “judge shopping” to get the decisions they want, is “an unprecedented attack on democracy meant to undermine the will of the vast majority of Americans who want this pill — mifepristone — to remain legal and available,” Heather Booth told CNN.

“This is a further weaponization of the courts to brazenly advance the end goal of banning abortion entirely,” she added.

If women in her day could have had access to medications that could be used safely in their homes, they would not have been forced to risk their lives, said Dorie Barron, thinking back to her own terrifying abortion in a sketchy Chicago motel.

“I’m depressed as hell, watching stupid, indifferent men control and destroy women’s lives all over again,” she said. “I really fear getting an abortion could soon be like 1965.”

Chicago college student Heather Booth had just finished a summer working with civil rights activists in Mississippi when she was asked to help with a different kind of injustice.

Heather Booth, 18, with civil rights heroine Fannie Lou Hamer during

A girl in another dorm was considering suicide because she was pregnant. Booth, who excelled at both organization and chutzpah, found a local doctor and negotiated an abortion for the girl. Word spread quickly.

“There were about 100 women a week calling for help, much more than one person could handle,” Booth said. “I recruited about 12 other people and began training them how to do the counseling.”

Counseling was a key part of the new service. This was a time when people “barely spoke about sex, how women’s bodies functioned or even how people got pregnant,” Booth said. To help each woman understand what was going to happen to them, Booth quizzed the abortion provider about every aspect of the procedure.

“What do you do in advance? Will it be painful? How painful? Can you walk afterwards? Do you need someone to be with you to take you home?” The questions continued: “What amount of bleeding is expected, and can a woman handle it on their own? If there’s a problem is there an urgent number they can call?”

Armed with details few if any physicians provided, the counselors at Jane could fully inform each caller about the abortion experience. The group even published a flyer describing the procedure, long before the groundbreaking 1970 book “Our Bodies, Ourselves” began to educate women about their sexuality and health.

“I don’t particularly like doctors because I always feel dissatisfied with the experience,” said Marie Learner, who spoke to many of the women who underwent an abortion at her home.

“But after their abortion at Jane, women told me, ‘Wow, that was the best experience I’ve ever had with people helping me with a medical issue.’”

Eileen Smith, now 73, was one of those women. “Jane made you feel like you were part of this bigger picture, like we were all in this together,” she said. “They helped me do this illegal thing and then they’re calling to make sure I’m OK? Wow!

“For me, it helped battle the feeling that I was a bad person, that ‘What’s wrong with me? Why did I get pregnant? I should know better’ voice in my head,” said Smith. “It was priceless.”

Like many young women in the 60s, Heather Booth often protested for civil and women's rights.

Many of the women who joined Jane had never experienced an abortion. Some viewed the work as political, a part of the burgeoning feminist movement. Others considered the service as simply humanitarian health care. All saw the work as an opportunity to respect each woman’s choice.

“I was a stay-at-home mom with four kids,” said Martha Scott, who is now in her 80s. “We knew the woman needed to feel as though she was in control of what was happening to her. We were making it happen for her, but it was not about us. It was about her.”

Some volunteers, like Dorie Barron, experienced the Jane difference firsthand when she found herself pregnant a few years after her abortion at the hands of the Mafia.

“It was a 100% total reversal — I had never experienced such kindness,” Barron said. Not only did a Jane hold each woman’s hand and explain every step of the process, “they gave each of us a giant supply of maternity sanitary pads, and a nice big handful of antibiotics,” she said. “And for the next week, I got a phone call every other day to see how I was.”

Barron soon began volunteering for Jane by providing pregnancy testing for women in the back of a church in Chicago’s Hyde Park.

“It wasn’t just abortion,” Barron explained. “We also said, ‘You could consider adoption,’ and gave adoption referrals. And if the woman wanted to continue with her pregnancy, we said, ‘Fine, please by all that is holy make sure you get prenatal care, take your vitamins, and eat as best you can.’ It was women helping women with whatever they needed.”

Most of the women who contacted Jane were unable to support themselves, in unhealthy relationships, or already had children at home, so the service was a way of “helping them get back on track,” said Smith, who, like Barron, had begun working for Jane after her abortion.

“We were telling them ‘This isn’t the end of the world. You can continue to leave your boyfriend or your husband or continue to just take care of those kids you have.’ We were there to help them get through this,” said Smith, who later became a homecare nurse.

From left: Eileen Smith, Diane Stevens and Benita Greenfield were three of the dozens of women who volunteered for Jane.

Diane Stevens says she came to work for Jane after experiencing an abortion in 1968 at the age of 19. She was living in California at the time, which provided “therapeutic abortions” if approved in advance by physicians.

“I’d had a birth control failure, and I was coached by Planned Parenthood on how to do this,” said Stevens, now 74. “I had to see two psychiatrists and one doctor and tell them I was not able to go through with the pregnancy because it would a danger to both my physical and mental health.

“I was admitted to the psychiatric ward, although I didn’t really know that — I thought I was just in a hospital bed. But oh no, ‘I was mentally ill,’ so that’s where they put me,” said Stevens, who later went to nursing school with Smith. “Then they wheeled me off for the abortion. I had general anesthesia, was there for two days, and then I was discharged. Isn’t that crazy?”

Sakinah Ahad Shannon, now 75, was one of the few Black women who volunteered as a counselor at Jane. She joined after accompanying a friend who was charged a mere $50 for her abortion. At that time, Jane’s fee was between $1 and $100, based on what the woman could afford to pay, Shannon said.

“When I walked in, I said, ‘Oh my God, here we go again. It’s a room of White women, archangels who are going to save the world,’” said Shannon, a social worker and member of the Congress of Racial Equality, an interracial group of non-violent activists who pioneered “Freedom Rides” and helped organize the March on Washington in 1963.

What she heard and saw at her friend’s counseling session was so impressive it “changed my life,” Shannon said. She and her family later opened and operated three Chicago abortion clinics for over 25 years, all using the Jane philosophy of communication and respect.

“It was a profoundly amazing experience for me,” she said. “I call the Janes my sisters. The color line didn’t matter. We were all taking the same risk.”

Sakinah Ahad Shannon and her daughters went on to open and run three abortion clinics in Chicago.

It wasn’t long before the women discovered a “doctor” performing abortions for Jane had been lying about his credentials. There was no medical degree — in the HBO documentary, he admitted he had honed his skills by assisting an abortion provider.

The group imploded. A number of members quit in horror and dismay. For the women who stayed, it was an epiphany, said Martha Scott. Like her, several of the Janes had been assisting this fake doctor for years, learning the procedures step by step.

“You’d learn how to insert a speculum, then how to swap out the vagina with an antiseptic, then how to give numbing shots around the cervix and then how to dilate the cervix. You learned and mastered each step before you moved on to the next,” said Laura Kaplan, who chronicled the procedure in her book.

By now, several of the Janes were quite experienced and willing to do the work. Why not perform the abortions themselves?

“Clearly, this was an intense responsibility,” said Judith Acana, a 27-year-old high school teacher who joined Jane in 1970. She started her training by helping “long terms,” women who were four or five months along in the pregnancy.

“Remember, abortion was illegal (in Illinois) so it could take weeks for a woman to find help,” said Arcana, now 80. “Frequently women who wanted an abortion at 8 or 10 weeks wound up being 16 or 18 weeks or more by the time they found Jane.”

The miscarriage could happen quickly, but it rarely did, she said. It usually took anywhere from one to two days.

“Women who had no one to help them would come back when contractions started,” Arcana said. “One of my strongest memories is of a teenage girl who had an appointment to have her miscarriage on my living room floor.”

The group also paid two Janes to live in an apartment and be on call 24/7 to assist women who had no one to help them miscarry at home, said Arcana, a lifelong educator, author and poet. “But many women took care of it on their own, in very amazing and impressive and powerful ways,” she said.

Judith Arcana learned how to do abortions herself and wrote about the Jane experience in poems, stories, essays and books.

Any woman who had concerns or questions while miscarrying alone could always call Jane for advice any time of the day or night.

“People would call in a panic: ‘The bleeding won’t stop,’” Smith recalled. “I would tell them, ‘Get some ice, put it on your stomach, elevate your legs, relax.’ And they would say ‘Oh my gosh, thank you!’ because they were so scared.”

For women who were in their first trimester, Jane offered traditional D&C abortions — the same dilation and curettage used by hospitals then and today, said Scott, who performed many of the abortions for Jane. Later the group used vacuum aspiration, which was over in a mere five to 10 minutes.

“Vacuum aspiration was much easier to do, and I think it’s less difficult for the woman,” Scott said. “Abortion is exactly like any other medical procedure. It’s the decision that’s an issue — the doing is very straightforward. This was something a competent, trained person could do.”

It was May 3, 1972. Judith Arcana was the driver that day, responsible for relocating women waiting at what was called “the front” to a separate apartment or house where the abortions were done, known as “the place.”

On this day, a Wednesday, the “place” was a South Shore high-rise apartment. Arcana was escorting a woman who had completed her abortion when they were stopped by police at the elevator.

“They asked us, ‘Which apartment did you come out of?’ And the poor woman burst into tears and blurted out the apartment number,” Arcana said. “They took me downstairs, put cuffs on me and hooked me to a steel hook inside of the police van.”

Inside the apartment on the 11th floor, Martha Scott said she was setting up the bedroom for the next abortion when she heard a knock at the door, followed by screaming: “You can’t come in!”

“I shut the bedroom door and locked it,” Scott said, then hid the instruments and sat on the bed to wait. It wasn’t long until a cop kicked the door in and made her join the other women in the living room.

“We tell this joke about how the cops came in, saw all these women and said, ‘Where’s the abortionist?’ You know, assuming that it would be a man,” Scott said.

By day’s end, seven members of Jane were behind bars: Martha Scott, Diane Stevens, Judy Arcana, Jeanne Galatzer-Levy, Abby Pariser, Sheila Smith and Madeleine Schwenk. Suddenly what had been an underground effort for years was front page headlines.

“Had we not gotten arrested, I think no one would ever have known about Jane other than the women we served,” Scott said.

Top: Sheila Smith and Martha Scott.
Bottom: Diane Stevens and Judith Arcana.

An emergency meeting of Jane was called. The turnout was massive — even women who had not been active in months showed up, anxious to know the extent of the police probe, according to the women with whom CNN spoke.

Despite widespread fear and worry, the group immediately began making alternate plans for women scheduled for abortions at Jane in the next few days to weeks. The group even paid for transportation to other cities where abortion had already been legalized, they said.

News reports over the next few days gave further details of the bust: There was no widespread investigation by the police. It was a single incident, triggered by a call from a sister-in-law who was upset with her relative’s decision to have an abortion, they said.

“It wasn’t long after I was arrested that I came back and worked for quite a few months,” said Scott, one of the few fully trained to do abortions.

“I like to think I was a good soldier,” Scott said. “I like to think what did made a difference not only to a whole bunch of people, but also to ourselves. It gave us a sense of empowerment that comes when you do something that is hard to do and also right.”

As paranoia eased, women began to come back to work at Jane, determined to carry on.

“After the bust, we had a meeting and were told ‘Everybody needs to start assisting and learn how to do abortions.’ I was like, ‘Whoa, whoa, whoa!’” said Eileen Smith, who had not been arrested. “But you felt like you really didn’t have much of a choice. We had to keep the service running.”

Laura Kaplan volunteered for the Janes, later immortalizing the group in her book,

The preliminary hearing for the arrested seven was in August. Several of the women in the apartment waiting for abortions the day of the arrest suddenly developed amnesia and refused to testify. According to Kaplan’s book, one of the women later said, “The cops tried to push me around, but f**k them. I wasn’t going to tell on you.”

It didn’t matter. Each Jane was charged with 11 counts of abortion and conspiracy to commit abortion, with a possible sentence of up to 110 years in prison.

As they waited for trial, the lawyer for the seven, Jo-Anne Wolfson, adopted delaying tactics, Kaplan said. A case representing a Texas woman, cited as “Jane Roe” to protect her privacy, was being considered by the US Supreme Court. If the Court ruled in Roe’s favor, the case against the Jane’s might be thrown out.

That’s exactly what happened. On March 9, 1973, three months after the Supreme Court had legalized abortion in the US, the case against the seven women was dropped and their arrest records were expunged.

Later that spring, a majority of Janes, burned out by the intensity of the work over the last few years, voted to close shop. An end of Jane party was held on May 20. According to Kaplan’s book, the invitation read:

“You are cordially invited to attend The First, Last and Only Curette Caper; the Grand Finale of the Abortion Counseling Service. RSVP: Call Jane.”

Today, most of the surviving members of Jane are in their 70s and 80s, shocked but somehow not surprised by the actions of abortion opponents.

“This is a country of ill-educated politicos who know nothing about women’s bodies, nor do they care,” said Dorie Barron. “It will take generations to even begin to undo the devastating harm to women’s rights.”

In the meantime, women should research all available options, keep that information confidential, seek support from groups working for abortion rights, and “share your education with as many women as you can,” Barron added.

As more and more reproductive freedoms have been rolled back over the past year, many of the Janes are angry and fearful for the future.

Abortion rights demonstrators walk across the Brooklyn Bridge in New York nearly two weeks after the leak of a draft Supreme Court opinion that would overturn Roe v. Wade.

“This is about the most intimate decision of our lives — when, whether and with whom we have a child. Everyone should have the ability to make decisions about our own lives, bodies, and futures without political interference,” said Heather Booth, who has spent her life after leaving Jane fighting for civil and women’s rights.

“We need to organize, raise our voices and our votes, and overturn this attack on our freedom and our lives. I have seen that when we take action and organize we can change the world.”

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Texas abortion drug ruling could create ‘slippery slope’ for FDA approvals, drug research and patients, experts say | CNN



CNN
 — 

What happened in one judge’s courtroom in Texas could have drastic effects for the United States’ entire drug approval process, experts warn.

US District Judge Matthew Kacsmaryk’s ruling that suspended the US Food and Drug Administration’s approval of the medication abortion drug mifepristone was an unprecedented one, the first time a court has bypassed the federal system set up to determine what drugs should be allowed on the market.

Regardless of whether the ruling – or a part of it – is ultimately allowed to stand, legal scholars, scientists and drugmakers are concerned that the decision could start a trend of drugs being targeted in courts, creating a chilling effect on drug development in the US and hurting patients in the process.

Vaccines, including the Covid-19 shots, antidepressants and psychotropic medicines could be at risk, some said.

“Well, one does not want to be Chicken Little,” former FDA Commissioner Dr. Jane Henney said Wednesday, but “I can’t imagine that it wouldn’t have implications for other products.

“The approval process will be at risk, and it’s not just an approval process that patients rely on and providers rely on, it’s one that has been considered the gold standard, really, for the world,” said Henney, who was the head of the FDA when mifepristone was approved.

Since the dawn of the 20th century, the FDA has had the sole authority in the United States to regulate drugs. In 1906, the federal government created the agency to enforce the Pure Food and Drug Act, which was instituted to ensure that medicine, food and cosmetics were safe.

Over the years, that authority became more defined.

After elixir of sulfanilamide, a drug used to treat streptococcal infections, killed 107 people in 1937, Congress created the Food, Drug, and Cosmetic Act. Signed into law in 1938 by President Franklin D. Roosevelt, it required manufacturers to conduct pharmacological studies to prove that their drugs were safe before they could be sold or advertised. In 1962, drug manufacturers were also required to prove to the FDA that their products were effective.

Modern drug approval in the US is a careful and conscientious process. Before any drug goes to market, there are countless hours of research, the work and expertise of multiple scientists, and several layers of oversight for approval.

Until now, the courts have been deferential to the FDA’s process and have never overturned an FDA decision on the grounds that the agency misjudged the science, said William Schultz, a former deputy commissioner at the FDA and former general counsel for the Department of Health and Human Services.

“Any FDA drug approval involves hundreds of judgments by the agency. And if a court feels free just to kind of take a fresh look at each of those, there’s a chance that a court will find one of those FDA judgments wrong,” Schultz said in an online discussion Monday about the impact of the Texas court’s ruling that was hosted by Protect Our Care, an organization that advocates for equitable and affordable health care.

Hundreds of well-known biotech and pharmaceutical company leaders, concerned about the effects of Kacsmaryk’s ruling on other drug approvals, signed an open letter Monday in support of the FDA’s authority “to approve and regulate safe, effective medicines for every American.”

The letter also advocated a reversal of the mifepristone decision from a judge with “no scientific training,” saying it “set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry.”

In a separate statement, the biotech industry group BIO’s interim president and CEO, Rachel King, emphasized the “dangerous precedent” the decision sets.

“The preliminary ruling by a federal judge in Texas is an assault on science and the FDA’s long-standing role as the authority to make decisions on the safety and efficacy of medicines. For a court to invalidate the approval of a drug that was reviewed and approved more than two decades ago is without precedent. As legal scholars have noted, the courts do not have the medical expertise to make these types of scientific determinations,” King said.

The main lobbying group for the pharmaceutical industry, PhRMA, criticized Kacsmaryk’s ruling as undermining the regulatory process.

“PhRMA has serious concerns with any court substituting its opinion for the FDA’s expert approval decision-making,” said James C. Stansel, the association’s executive vice president, general counsel and corporate secretary. Stansel added that such a decision could have a “chilling effect on the research and development ecosystem.”

The pharmacutical sector is a huge part of the American economy. Of the world’s 25 largest phamacutical companies, 10 are based in the US, and most of the others have a large base of operations in the country.

Often, the US market is the first to get access to new drugs, but that could change if lawsuits undermine the regulatory integrity of the FDA process, said Susan Lee, partner in the law firm Goodwin’s Life Sciences group and Life Sciences Regulatory & Compliance practice, who works with companies to get drugs approved by the FDA.

“If there do tend to be more lawsuits like this, I wonder if there might be a little bit of a tendency to not always look at the US as the first market,” Lee said. “Some manufacturers may say ‘we’d rather go to Europe, where we’re not going to be sued on a jurisdiction-by-jurisdiction basis.’ “

Lee also wonders whether manufacturers will abandon efforts to develop drugs that could be considered unappealing to some, such as those that help women’s health or work to prevent HIV.

“I think there are just certain sectors that are already kind of thinking about whether they might also have a target on their back. I’ve definitely heard that discussed,” Lee said.

The groups at the heart of the Texas case have not disclosed any further plans regarding lawsuits over medications, but experts say they are already hearing concern.

“I’ve already been getting questions from lawmakers and other people about ‘could the Covid vaccine be next?’ or other things that may have stigma around it,” said Dr. Kristyn Brandi, an ob/gyn and abortion provider in New Jersey and a spokesperson for the American College of Obstetricians and Gynecologists.

The Covid-19 vaccines have been thoroughly tested and found to be safe and effective, but they’re the subject of conspiracy theories and misunderstanding about how mRNA vaccines were tested. Beliefs that the vaccines were tested on recently harvested aborted fetal cells made some people decidedly anti-vaccine.

Dr. Lynn R. Goldman, professor and dean of the Milken Institute School of Public Health at George Washington University, is also concerned that mRNA vaccines could be targeted soon.

“There might be people who disagree with some of the technologies that are used by vaccine makers, like the mRNA vaccines, but feeling uncomfortable about a technology is not the same thing as identifying that there is risk,” she said in the Protect Our Care conversation.

Members of the LGBTQ+ community may also be vulnerable, experts say, as activists could target puberty blockers or hormones used in gender-affirming therapy.

“I don’t like to do slippery slope, but I’m also very worried about things like gender-affirming care, since there’s already been so many laws about that recently in other states,” Brandi said.

There is political pressure against other vaccines, antidepressants and psychotropic medicines, among others, former FDA Commissioner Margaret Hamburg and former Principal Deputy Commissioner Joshua Sharfstein wrote in an editorial published Thursday in the journal Science.

“If judges begin to dictate the terms of medication access, then others will seek to use ideology and influence to advance their agendas,” they warn.

Goldman said that any legal decision that could undermine the FDA drug approval process would ultimately hurt the doctors who prescribe them and the people who use them.

Doctors don’t have time to vet all the studies used to prove that a drug is safe and effective, so they rely on the FDA for this work, she said. Court interference could confuse this process.

“I think that this is, for doctors, an incredibly serious moment, because up to now, we have been able to trust that an approval by the FDA is a science-based decision and that we can say that if the FDA has approved a drug, that it is safe for us to use,” Goldman said.

A lack of confidence in the drug approval process will ultimately hurt people far beyond the most recent decision, Protect Our Care Chair Leslie Dach says.

“Confidence that the FDA can do its work is essential for clinicians and patients who depend on it in its decision-making for matters of life and death,” Dach said.

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