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☆ DeSantis Spreads Vaccine Skepticism With Guidance That Contradicts C.D.C.
▼ + stars: | 2023-09-14 | by ( Anjali Huynh | More About Anjali Huynh | ) www.nytimes.com time to read: +1 min

Ron DeSantis of Florida’s administration issued Covid-19 vaccine recommendations this week that directly contradicted federal officials’ guidance as his presidential campaign tries to use the resurgence of the virus to appeal to Republican voters. With cases ticking up, the Centers for Disease Control and Prevention recommended on Tuesday that everyone six months and older who had not received a Covid-19 shot in the last two months receive a booster vaccine. The new shots, approved by the Food and Drug Administration this week, appear to be effective against a vast majority of Covid-19 variants now in circulation, according to data presented at a C.D.C. Mr. DeSantis’s administration advised that Florida residents under the age of 65 skip the updated boosters. use healthy Floridians as guinea pigs for new booster shots,” Mr. DeSantis, who has a history of downplaying the efficacy of Covid-19 vaccines, said in a statement after he hosted an online panel Wednesday to discuss the new federal guidelines.

Persons: Ron DeSantis, DeSantis’s, ” Mr, DeSantis Organizations: Republican, Centers for Disease Control, Food and Drug Administration Locations: Florida

☆ A Decongestant in Cold Medicines Doesn’t Work at All, an F.D.A. Panel Says
▼ + stars: | 2023-09-12 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +3 min

Every cold and flu season, millions of Americans reach for these products, some over decades. The decongestant is in at least 250 products that were worth nearly $1.8 billion in sales last year, according to an agency presentation. Among the products: Sudafed Sinus Congestion, Tylenol Cold & Flu Severe, NyQuil Severe Cold & Flu, Theraflu Severe Cold Relief, Mucinex Sinus Max and others. The ingredient has long been considered safe and effective under an old, outdated agency standard, and the F.D.A. The agency also may give the drug companies a grace period to swap ingredients in products, if required.

Persons: Leslie Hendeles, Hendeles, ”, Marcia D, Howard Organizations: Staples, Medicine Cabinet, University of Florida, Consumer Healthcare Products Association, White

☆ Treating Overdoses Over the Counter
▼ + stars: | 2023-09-11 | by ( German Lopez | More About German Lopez | ) www.nytimes.com time to read: +1 min

The F.D.A.’s approval of Narcan, a nasal spray, in 2015 made naloxone easier to administer. So police officers and other emergency responders started to carry it to reverse overdoses they would have been powerless to stop before. But public health advocates have called for many more Americans to carry naloxone to try to stop overdoses. Greater availability of the medication is one of the most effective interventions against the drug crisis, experts have said. “Everyone should be thinking about putting this into their first aid kit,” Dr. Kevin Ban, Walgreens’s chief medical officer, told CNN.

Persons: ’, Dr, Kevin Ban, “ It’s Organizations: The Times, CNN

☆ Trader Joe’s Recalls Tamales After Potential Milk Contamination
▼ + stars: | 2023-08-30 | by ( Eduardo Medina | More About Eduardo Medina | ) www.nytimes.com time to read: +1 min

Trader Joe'sTrader Joe’s said that no illnesses had been reported in connection with the latest recall and that all potentially affected products had been removed from sale. Customers have been warned in recent weeks that other products might have been contaminated with rocks, insects and metal. In July, Trader Joe’s said that it had removed cookies because they may have contained rocks and its Unexpected Broccoli Cheddar Soup because it may have contained insects. On Aug. 17, Trader Joe’s said that its multigrain crackers with sunflower and flax seeds were recalled because of potential metal contamination. Its popularity has even spawned Trader Joe’s food review Instagram accounts with hundreds of thousands of followers.

Persons: Joe’s

☆ Wait, Is That Rapid Test Really Expired?
▼ + stars: | 2023-08-29 | by ( Dani Blum | More About Dani Blum | ) www.nytimes.com time to read: +2 min

If a test is delivered to you on a sweltering day, for example, the agency recommends bringing the package inside and waiting at least two hours before opening it. And always make sure the control line — which typically appears next to the “C” — shows up when you use a rapid test; otherwise, the test may be damaged or faulty. If you have Covid symptoms and someone you had been spending time with is now positive, test immediately. says to wait at least five days before testing because swabbing too early can give you a false negative. “Especially people who have been recently boosted,” he said, “if they get infected, they might become symptomatic 24 hours post-exposure, 48 hours post-exposure — really fast.”

Persons: Peter Chin, Sala, . Chin, Hong, Michael Mina, Harvard epidemiologist, ” Organizations: University of California, Harvard Locations: San Francisco

☆ Faulty Oxygen Readings Delayed Care to Black and Hispanic Covid Patients, Study Finds
▼ + stars: | 2023-08-24 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +4 min

Pulse oximeter readings are used routinely and help inform doctors in shaping medical care for any number of illnesses, including heart failure, sleep apnea and respiratory conditions. If the readings are falsely high, patients may look fine on paper — but they may not get the level of care they need. Black patients were found to be nearly 50 percent more likely than white patients to have their condition go undetected. Hispanic patients were 18 percent more likely than white patients to have an unrecognized need. Patients with unrecognized needs, regardless of race, experienced delays of roughly an hour that translated into a 10 percent higher risk of delayed Covid treatment.

Persons: “, ”, Ashraf Fawzy, Johns Hopkins, Fawzy Organizations: Drug Administration

☆ The U.S. Regulates Cars, Radio and TV. When Will It Regulate A.I.?
▼ + stars: | 2023-08-24 | by ( Ian Prasad Philbrick | More About Ian Prasad Philbrick | ) www.nytimes.com time to read: +1 min

Historically, regulation often happens gradually as a technology improves or an industry grows, as with cars and television. In 1937, an untested and poisonous liquid version of sulfanilamide, meant to treat bacterial infections, killed more than 100 people across 15 states. “Before we seek to regulate, we have to understand why we are regulating,” said Representative Jay Obernolte, a California Republican who has a master’s degree in A.I. “Only when you understand that purpose can you craft a regulatory framework that achieves that purpose.”Brain drainEven so, lawmakers say they’re making strides. “Congress is taking the issue really seriously,” said Camille Carlton of the Center for Humane Technology, a nonprofit that regularly meets with lawmakers.

Persons: ”, Jonathan Lewallen, Jay Obernolte, ” Mr, Obernolte, Camille Carlton Organizations: Food and Drug Administration, University, Tampa, California Republican, Center for Humane Technology Locations: California, A.I

☆ U.S. Sunscreen Is Stuck in the ’90s. Is This a Job for Congress?
▼ + stars: | 2023-08-12 | by ( Sandra E. Garcia | ) www.nytimes.com time to read: +2 min

Many sunscreen ingredients that have appeared in foreign-made sunscreens for decades, favored by consumers for their ease of use, are still awaiting approval by the F.D.A. The ultraviolet-filtering compounds amiloxate, enzacamene and octyl triazone, for instance, have all been stuck in the F.D.A. In November 2014, President Barack Obama signed the Sunscreen Innovation Act into law. five years to approve or deny the use of new sunscreen ingredients, including several that had been under review since 2002. said it was committed to helping “facilitate the marketing of sunscreen products that include additional over-the-counter sunscreen active ingredients.” It continued, “To do so, the F.D.A.

Persons: octyl, Barack Obama, ”, Thomas F, Myers, “ Organizations: Care Products Council

☆ Judge Strikes Down F.D.A. Rule Regulating Premium Cigars
▼ + stars: | 2023-08-10 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +3 min

“All cigars, including premium cigars, can cause death and disease, and no tobacco product should be without regulation of any kind,” he said. began a process to regulate cigars. The agency did ask for public comment over whether premium cigars could be regulated less rigorously. opted to require premium cigar makers to conduct extensive studies of their products, list ingredients and register them annually. The agency concluded that regulating all cigars equally “more completely protects the public health.”Groups supporting the cigar industry, in turn, sued.

Persons: Thomas Carr, Mr, Carr, Michael Edney, Hunton Andrews Kurth, ”, “, ’ ” Organizations: Public, American Lung Association, American Heart Association, American Academy of Pediatrics, American Cancer Society, Tobacco Control, Rights, America, Congress

Here are the meanings of the least-found words that were used in (mostly) recent Times articles. regulations define milk as a “lacteal secretion” obtained by milking “one or more healthy cows.” — Got Almond Milk? Those chemicals, the researchers said, may be especially irritating to the lungs and can cause damage when inhaled. — Dozens of Young People Hospitalized for Breathing and Lung Problems After Vaping (Aug. 14, 2019)3. titmice — any of several small birds:But enterprising birds can be mischievous. Like the titmice and other Parids that steal hair from dogs, raccoons and even humans, probably to fortify their nests.

Persons: lacteal, acetal, Duke, Young, —, unceded —, ecocide ”, ”, Vergollo, — Michael Batayeh, trimaran, Barth, Erick Clement, “, ” — Alexander Toradze Organizations: Food and Drug Administration, Yale, Art Schools, Johnsons, Racing Locations: New, Hudson, St

☆ Divided Over Money and Policy, House G.O.P. Punts on Spending Bill
▼ + stars: | 2023-07-27 | by ( Carl Hulse | More About Carl Hulse | ) www.nytimes.com time to read: +1 min

House Republicans abandoned efforts to pass a spending bill to fund the Agriculture Department and the F.D.A. Caught between hard-right conservatives who wanted tens of billions of dollars cut from the legislation and more mainstream Republicans who oppose abortion-related restrictions that the far right insisted upon adding, G.O.P. The House did manage to approve its first spending bill of the year, to fund veterans programs and military construction projects. Democrats said the bill shortchanged construction by more than $1.5 billion and limited abortion access for women serving in the military. The spending clashes encapsulated the difficulties ahead for Republicans as Speaker Kevin McCarthy tries to mollify conservatives by cutting spending and adding culture-war provisions without losing the support of more mainstream Republicans, particularly those in districts won by President Biden.

Persons: Kevin McCarthy, Biden Organizations: Republicans, Agriculture Department, Democrats

☆ What You Should Know About the Potential Risks of Kratom
▼ + stars: | 2023-07-26 | by ( Dani Blum | More About Dani Blum | ) www.nytimes.com time to read: +1 min

Across gas stations, smoke shops and the internet, consumers can easily buy kratom — an herbal substance that some users claim is an antidote to opioid dependence and a lifeline for alleviating mental and physical pain. In 2021 alone, roughly 1.7 million Americans used kratom, although the F.D.A. has not approved it for any medical use. Despite those warnings, kratom largely remains legal and accessible across the United States. It’s up to consumers to weigh the allure of what some consider a more “natural” alternative to opioids against the stark warnings from health officials.

Persons: ” Organizations: Drug Administration, Drug, Administration, Disorders, University of Louisville School of Medicine Locations: United States, ”, Rif

☆ Over-the-Counter Birth Control Pills Are Coming. What Next? - The New York Times
▼ + stars: | 2023-07-19 | by ( Daniel Grossman | ) www.nytimes.com time to read: +2 min

Like many of my colleagues, I’ve been holding my breath for the last year, since HRA Pharma, which manufactures Opill, submitted its application to the F.D.A. We now have hope that other advances could be coming to help offset restrictions on minors’ access to contraception and state-level abortion bans. under President George W. Bush approved Plan B for over-the-counter sale, but only for people 18 or older. Because of the age restriction, the product was shunted behind the pharmacy counter, where the consumer’s age could be confirmed. asked Plan B’s sponsor for additional data on people 17 and younger to show the product could be used safely and effectively by adolescents.

Persons: Roe, — Opill, I’ve, Opill, George W, Bush Organizations: Food and Drug Administration, HRA Pharma

☆ F.D.A. Approves R.S.V. Shot for Infants
▼ + stars: | 2023-07-17 | by ( Christina Jewett | More About Christina Jewett | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration on Monday approved a shot to protect infants and vulnerable toddlers against respiratory syncytial virus, or R.S.V., offering one of the first protections for an illness that fills children’s hospitals year after year. The monoclonal antibody shot is expected to be available at the start of the fall R.S.V. vaccine by Pfizer for pregnant women that is meant to protect infants from the virus. can cause serious disease in infants and some children and results in a large number of emergency department and physician office visits each year,” Dr. John Farley, an official in the F.D.A. “Today’s approval addresses the great need for products to help reduce the impact of R.S.V.

Persons: ” Dr, John Farley, “ Organizations: Drug Administration, Pfizer, Sanofi, AstraZeneca, Centers for Disease Control, Center, Drug, Research

☆ Women React to News About an Over-the-Counter Birth Control Pill
▼ + stars: | 2023-07-14 | by ( Alisha Haridasani Gupta | More About Alisha Haridasani Gupta | ) www.nytimes.com time to read: +2 min

An over-the-counter pill would eliminate a lot of barriers, she said. For young people, accessing birth control can be “really challenging,” she said. The New York Times interviewed 18 women and girls about the F.D.A. “My mom does not approve of birth control” because of her more conservative Sri Lankan heritage, said Tharushi Samarasinghe, a 19-year-old student at Hunter College. “I took birth control once for hormonal issues as I was going through puberty.

Persons: greenlight, Elise Berlan, ”, KFF, Tharushi Samarasinghe, “, ’ ” Elizabeth, I’m Organizations: Nationwide Children’s Hospital, New York Times, Hunter College Locations: United States, Columbus , Ohio, Sri Lankan

☆ The W.H.O. Says Aspartame Is ‘Possibly Carcinogenic.’ What Does That Mean?
▼ + stars: | 2023-07-13 | by ( Dani Blum | More About Dani Blum | ) www.nytimes.com time to read: +1 min

According to the W.H.O., it is safe to consume up to 40 milligrams of aspartame per kilogram of body weight per day. The Food and Drug Administration is slightly more permissive with its daily safety limit. It states that people can have up to 50 milligrams of aspartame per kilogram of body weight each day. as ‘possibly carcinogenic to humans’ does not mean that aspartame is actually linked to cancer,” the official wrote. Reaching that upper daily level of aspartame intake “isn’t casual consumption,” said Dr. Dale Shepard, a medical oncologist at the Cleveland Clinic.

Persons: ”, Dale Shepard Organizations: Drug Administration, Cleveland Clinic

☆ F.D.A. Approves First U.S. Over-the-Counter Birth Control Pill
▼ + stars: | 2023-07-13 | by ( Pam Belluck | More About Pam Belluck | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration on Thursday approved a birth control pill to be sold without a prescription for the first time in the United States, a step that could significantly expand access to contraception. The medication, called Opill, will become the most effective birth control method available over the counter — more effective at preventing pregnancy than condoms, spermicides and other nonprescription methods. Experts in reproductive health said its availability could be especially useful for young women, teenagers and those who have difficulty dealing with the time, costs or logistical hurdles involved in visiting a doctor to obtain a prescription. The pill’s manufacturer, Perrigo Company, based in Dublin, said Opill would most likely become available from stores and online retailers in the United States in early 2024. The company did not say how much the medication would cost — a key question that will help determine how many people will use the pill — but Frédérique Welgryn, Perrigo’s global vice president for women’s health, said in a statement that the company was committed to making the pill “accessible and affordable to women and people of all ages.” Ms. Welgryn has also said the company would have a consumer assistance program to provide the pill at no cost to some women.

Persons: Opill, Ms, Welgryn Organizations: Drug Administration, Perrigo Locations: United States, Dublin

☆ What to Know if You’re Considering the Alzheimer’s Drug Leqembi
▼ + stars: | 2023-07-06 | by ( Pam Belluck | More About Pam Belluck | ) www.nytimes.com time to read: +1 min

On Thursday, the Food and Drug Administration gave full approval to the drug Leqembi for patients who are in the early stages of Alzheimer’s disease, and Medicare said it would cover 80 percent of the cost of the $26,500-per-year medication. The decisions by the two federal agencies will vastly increase access to the drug but also present a dilemma for patients and their families. Leqembi is not a cure for Alzheimer’s, and the drug doesn’t improve patients’ memories or cognitive abilities. What Leqembi can do is modestly slow down cognitive decline in patients who are in the early stages of the disease. Data from a large clinical trial suggested that the drug may slow decline by about five months over a period of 18 months for those patients.

Persons: ” Organizations: Food and Drug Administration, Medicare

☆ New Federal Decisions Make Alzheimer’s Drug Leqembi Widely Accessible
▼ + stars: | 2023-07-06 | by ( Pam Belluck | More About Pam Belluck | ) www.nytimes.com time to read: +1 min

The Food and Drug Administration on Thursday gave full approval to the Alzheimer’s drug Leqembi, and Medicare said it would cover much of its high cost, laying the foundation for widespread use of a medication that can modestly slow cognitive decline in the early stages of the disease but also carries significant safety risks. The F.D.A.’s decision marks the first time in two decades that a drug for Alzheimer’s has received full approval, meaning that the agency concluded there is solid evidence of potential benefit. But data from a large clinical trial suggests that the drug — administered every two weeks as an intravenous infusion — may slow decline by about five months over about 18 months for people with mild symptoms. Still, some Alzheimer’s experts have said it is unclear from the medical evidence whether Leqembi’s ability to delay erosion of memory and cognition would be enough to be noticeable or meaningful for patients and their families. And while most cases of brain swelling and bleeding have been mild or moderate and have resolved, there have been some serious cases.

Persons: Alzheimer’s Organizations: Drug Administration, Medicare

☆ My Best Friends Are Taking Ozempic. Can I Share My Disapproval?
▼ + stars: | 2023-06-28 | by ( Kwame Anthony Appiah | ) www.nytimes.com time to read: +2 min

Recently, two of my good friends (neither of whom is obese) have joined the masses taking semaglutide for weight loss. I’m conflicted about the safety and popularity of these drugs for weight loss, and so I’ve remained silent whenever this topic comes up. Our annual trip is coming up, and I fear I’ll be forced to offer my opinion about their weight loss, especially since the trip involves time at the pool. You imply there’s a moral problem about taking the drug, but you don’t say what it is. But if what’s really bothering you is the thought that your friends are taking the easy way out, well, I doubt that’s a cogent position.

Persons: I’ve, I’ll, It’s, hasn’t, they’ve Locations: United States

☆ Barbie, Her House and the American Dream
▼ + stars: | 2023-06-23 | by ( Anna Kodé | ) www.nytimes.com time to read: +17 min

Barbie, Her House and the American Dream Take a stop-motion journey with the young, single homeowner of the Dreamhouse. Today according to Mattel, the toymaker behind the iconic doll, a new Barbie Dreamhouse is sold every two minutes. A vintage Barbie doll puts a record on, dances and sits down. He came to Barbie’s house.”Now, Ms. Dalsing lives in Saint Joseph, Mo., in what she called her own dream house. “In the early 2000s, single women were the fastest growing group of home buyers in the United States,” she said.

Persons: Ken isn’t, Barbara Millicent Roberts, Roberts —, Barbie, ” Ruth Handler, Ken, Handler’s, —, Barbie’s Dreamhouse, ”, Deborah Dinner, wasn’t, weren’t, Barbie’s, Felix Burrichter, “ Barbie Dreamhouse, ” Barbie’s, Sue Dalsing, Dalsing, “ Ken didn’t, “, ” It’s, Elliot Handler, Handler, Lisa McKnight, Mattel’s Barbie, Hugh Hefner’s, Helen Gurley Brown’s, ’, Brown’s, Brown, Young, Tiffany, Barbie —, Houseplants, Burrichter, might’ve, Maddie Bone, Bone, Homer, …, Ms, Amy Castro, ” Ms, Castro, Isabelle Roy, ‘, Roy, He’s, Barbie couldn’t, Christie, Kim Culmone, Catherine E, McKinley, Sarah Greenwood, Katie Spencer, Greenwood, Spencer, It’s Organizations: Mattel, New York Times, “, Cornell University, Survey, Wisconsin ., Furniture, The Times, Spice, University of Pennsylvania’s School of Social Locations: crave, Britain, Saint Joseph, Mo, Barbie’s, Wisconsin, Levittown, Waldoboro, United States, Canadian, Alberta, Palm Springs

☆ F.D.A. Panel Advises Vaccine Makers to Aim at Only One Covid Variant
▼ + stars: | 2023-06-15 | by ( Christina Jewett | ) www.nytimes.com time to read: +2 min

The bivalent shots offered last fall included protection against the Omicron variant and an early Covid variant. is expected to make a more official recommendation to vaccine makers soon. The manufacturers will be expected to study the new formulas and submit data to the agency. spokesman said it expected that an updated vaccine would be available by late September, assuming the data support safe and effective vaccines. It remains unclear whether or when the vaccine makers or the F.D.A.

Persons: ”, Peter Marks, Natalie Thornburg Organizations: Pfizer, Moderna, Centers for Disease Control, World Health Organization, Agency Locations: United States

☆ Frozen Strawberries Are Recalled After Hepatitis A Infections
▼ + stars: | 2023-06-14 | by ( Matt Twomey | ) www.nytimes.com time to read: +1 min

A voluntary recall of frozen strawberries has been expanded as the Food and Drug Administration has linked more retailers to a string of nine hepatitis A cases that date back to last year. On Monday, the Willamette Valley Fruit Company of Salem, Ore., announced the recall of frozen strawberries that are sold at Walmart, Costco, and HEB stores under the brand names Great Value at Walmart and Rader Farms Organic at Costco and HEB. “Consumers, restaurants, and retailers should not sell, serve, or eat recalled frozen strawberries,” the F.D.A. investigation has traced hepatitis A infections to frozen organic strawberries imported from Baja California, Mexico, and reported the first five cases of hepatitis A linked to them in March. The strain of hepatitis A in those cases was genetically identical to one that caused an outbreak of hepatitis A infections in 2022, which was also linked to fresh organic strawberries imported from Baja California, Mexico.

Persons: “, they’re Organizations: and Drug Administration, Fruit, Walmart, Costco, Rader, HEB, “ Locations: Willamette, Salem, Ore, Washington State , California, Oregon, Baja California, Mexico

☆ Energy Drinks Are Surging. So Are Their Caffeine Levels.
▼ + stars: | 2023-06-09 | by ( Julie Creswell | ) www.nytimes.com time to read: +2 min

A 12-ounce can of Red Bull contains about 114 milligrams of caffeine — more than three times the amount in a 12-ounce can of Coca-Cola. Prime Energy has more: 200 milligrams in each 12-ounce can. A 16-ounce can of Bang Energy Drink, the size typically sold in convenience stores, has 300 milligrams of caffeine. The Food and Drug Administration has investigated a handful of reports over the years involving people dying shortly after consuming energy drinks or five-hour energy shots. Pediatricians recommend that youths ages 12 to 18 should not consume more than 100 milligrams of caffeine per day and that children under 12 should avoid caffeine completely.

Persons: Red Bull, Paul, Bull, ”, Ryan Stanton Organizations: . Prime Energy, Bang Energy, Mr, Prime Energy, ”, Drug Administration Locations: Britain, Lexington, Ky

☆ Opinion | How to Fix the National Drug Shortage
▼ + stars: | 2023-06-02 | by ( Peter Coy | ) www.nytimes.com time to read: +3 min

If a drug manufacturer wants to supply a hospital, nursing home or other institution, it has almost no choice but to go through one of these organizations. The manufacturers pay fees to the group purchasing organization for access to its customers. The fees paid by manufacturers might ordinarily be considered illegal kickbacks under the federal anti-kickback law. That safe harbor sticks in the craw of the group purchasing organizations’ critics. “It’s the biggest scam in America, in my opinion,” Phillip Zweig, the executive director and co-founder of Physicians Against Drug Shortages, told me.

Persons: “, ” Phillip Zweig, Zweig, Sara Sirota, Critics, Todd Ebert Organizations: Department of Health, Human Services, Physicians, BusinessWeek, American Economic Liberties, Federal Trade Commission, Akorn Pharmaceuticals, Bloomberg, India’s pharma, Healthcare, Chain Association Locations: America, United States, India

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