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May 25, 2023

Vaccines Fast Facts | CNN

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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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May 21, 2023

It’s a myth that women don’t want sex as they age, study finds | CNN

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CNN
—

It’s a myth that women lose interest in sex as they enter midlife and beyond, according to research that followed more than 3,200 women for about 15 years.

“About a quarter of women rate sex as very important, regardless of their age,” said Dr. Holly Thomas, lead author of an abstract presented during the September 2020 virtual annual meeting of the North American Menopause Society.

“The study showed substantial numbers of women still highly value sex, even as they get older, and it’s not abnormal,” said Thomas, an assistant professor of medicine at the University of Pittsburgh.

“If women are able to speak up with their partner and make sure that they’re having sex that’s fulfilling and pleasurable to them, then they’re more likely to rate it as highly important as they get older,” she said.

“That’s actually quite refreshing, that there were a quarter of women for whom sex remains not just on the radar but highly important,” said Dr. Stephanie Faubion, medical director for the North American Menopause Society, who was not involved in the study.

“Studies like these provide valuable insights to health care providers who may otherwise dismiss a woman’s waning sexual desire as a natural part of aging.”

It’s true that past studies have found that women tend to lose interest in sex as they age. But women’s health practitioners say that attitude doesn’t jibe with the reality they see.

“Some of the prior studies had suggested that sex goes downhill and all women lose interest in sex as they get older,” Thomas said. “That really isn’t the type of story that I hear from all my patients.”

One issue, she said, is that past studies took a single snapshot of a woman’s desire at one point in her life and compared it with similar snapshots in later decades of life.

“That type of longitudinal study would just show averages over time,” Thomas said. “And if you look at things on average, it may look like everyone follows one path.”

The study presented in 2020 used a different type of analysis that allowed researchers to follow the trajectory of a woman’s desire over time, Thomas said then.

“We wanted to use this different type of technique to see if there really were these different patterns,” she said. “And when you look for these trajectories, you see there are significant groups of women who follow another path.”

The research, which analyzed data from a national multisite study called SWAN, or the Study of Women’s Health Across the Nation, found three distinct pathways in a woman’s feelings about the importance of sex.

About a fourth of the women (28%) followed traditional thinking on the subject: They valued sex less during midlife years.

However, another fourth of the women in the study said the exact opposite. Some 27% of them said sex remains highly important throughout their 40s, 50s and 60s — a surprising contradiction of the belief that all women lose interest in sex as they age.

“Sex is going to look different,” said Faubion, who is director of the Mayo Clinic’s Center for Women’s Health.

“It’s not going to look the same at 40 as it does at 20; it’s not going to look the same at 60 as it does at 40, and it’s not going to look the same at 80 as it did at 60,” she said. “There may be some modifications that we have to do, but people in general who are healthy and in good relationships remain sexual.”

Women in the study who highly valued sex shared the following characteristics: They were more highly educated, they were less depressed, and they had experienced better sexual satisfaction before entering midlife.

“Women who were having more satisfying sex when they were in their 40s were more likely to continue to highly value sex as they got older,” Thomas said.

There could also be socioeconomic factors at play, she added. For example, more highly educated women may have higher incomes and feel more stable in their lives with less stress.

“Therefore they have more headspace to make sex a priority because they’re not worrying about other things,” Thomas said.

The study found another factor important to both lower-interest and high-interest pathways — race and ethnicity.

African American women were more likely to say sex was important to them for the duration of midlife, while Chinese and Japanese women were more likely to rate sex as having low importance throughout their midlife years.

“I do want to emphasize that it’s much more likely to be due to sociocultural factors than any biological factor,” Thomas said. “Women from different cultural groups have different attitudes … different comfort levels about getting older … and whether it’s ‘normal’ for a woman to continue to value sex as she gets older.”

The majority of women (48%) fell into a third pathway: They valued a healthy sex life as they entered the menopausal years but gradually lost interest throughout their 50s or 60s.

There are a number of emotional, physical and psychological factors that might affect how a woman views sex, experts say. Most can be divided into four categories:

Medical conditions: As women enter perimenopause in their 40s and 50s, they begin to experience hormonal changes that can cause sex to become less satisfying or even painful.

The drop in estrogen causes the vulva and vaginal tissues to become thinner, drier and more easily broken, bruised or irritated. Arousal can become more difficult. Hot flashes and other signs of menopause can affect mood and sleep quality, leading to fatigue, anxiety, irritability, brain fog and depression.

Many medical conditions can arise or worsen during midlife that can also affect libido.

“Do they have medical conditions like hip arthritis that cause pain with sex? Or hand arthritis that can make it more difficult? Or things like diabetes where their sensation is not the same, or do they have heart disease?” Faubion asked.

“But there are modifications that we talk about all the time to help people remain sexual, even for quadriplegics,” she said. “There are ways to stay sexual despite disability.”

Mental and emotional considerations: The psychological component of sex can have a huge influence on a woman’s levels of sexual desire. A history of sexual or physical abuse, struggles with substance abuse and depression, anxiety and stress are major players in this category.

“I can’t tell you enough about the impact of anxiety and stress on sex,” Faubion said. “Think of that fight or flight mechanism — your adrenaline’s pumping so you’re back in caveman days and a lion is chasing you.

“Are you going to lie down on the grassy knoll and have sex when the lion is chasing you? The answer is no. And that’s how women with anxiety are all the time, so anxiety is a huge, huge factor for whether women will be sexual.”

While the study did not look specifically at anxiety, results showed women with more symptoms of depression were much less likely to rate sex as a priority in life. In addition to the emotional impact, a reduced libido is a side effect of many antidepressants prescribed to treat depression.

Partner component: Women in midlife can also face dramatic and disturbing changes in their romantic lives that can take a major toll on their interest in sex.

“Are they losing a romantic partner to divorce or to death? Is a romantic partner developing health issues that make sex more difficult or inconvenient? Are they getting busy in other aspects of their life — their career, caring for grandchildren or even grown children who are moving back in? That makes it hard to prioritize sex,” Thomas said.

Even if they have a partner, relationships may have had ups and downs that can affect how a woman feels about intimacy with a significant other.

“Do you like your partner?” Faubion asked. “Is your communication good? Even logistics can get in the way — are you in the same place at the same time?”

Social mores: Society also affects how a woman feels about sex. Religious, cultural and family values about the topic can play a large role in sexual ease and satisfaction.

“Then there’s what society teaches us about aging women,” Faubion said. “And so for some women being sexual is somehow bad. Women aren’t supposed to like sex.”

“I’ve seen plenty of women in my clinic in the 60-to-65 age group who never got any sex education, their partners never got any sex education, and they don’t really want to know about all that stuff.”

Of course, if a woman isn’t bothered by a lack of sex, then there’s no reason to see a doctor, Faubion and Thomas said. But they both said that past studies have shown that about 10% to 15% of women who do have a lower interest in sex are bothered by it and would like to seek a solution.

There are ways in which physicians can help, including medications and therapies, but first a woman must reach out and talk to her doctor.

“Prior research has shown that women often really do hesitate to reach out to their doctors, perhaps because they’re embarrassed or they see it as part of normal aging and and don’t think it’s worth bringing up,” Thomas said.

Faubion added, “Bottom line: Women should talk to their providers if they’re having concerns about their sexual health. It’s an important part of life, and there are solutions for women who are struggling with that.”

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May 20, 2023

Conjoined Twins Fast Facts | CNN

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CNN
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Here’s a look at conjoined twins.

Conjoined twins are physically connected to one another at some point on their bodies.

Conjoined twins occur once every 200,000 live births, according to the University of Minnesota.

About 70% of conjoined twins are female.

Conjoined twins are identical – they are the same sex.

According to the Mayo Clinic, conjoined twins may be joined at any of these areas: chest, abdomen, spine, pelvis, trunk or head.

Scientists believe that conjoined twins develop from a single fertilized egg that fails to separate completely as it divides.

The term “Siamese twins” originated with Eng and Chang Bunker, a set of conjoined twins who were born in Siam (now Thailand) in 1811. They lived to age 63 and appeared in traveling exhibitions. Chang and Eng both married and fathered a total of 21 children between them.

In 1955, neurosurgeon Dr. Harold Voris of Mercy Hospital in Chicago performed the first successful procedure separating conjoined twins.

Lea and Tabea Block
Born August 9, 2003, in Lemgo, Germany, to Peter and Nelly Block. They are joined at the head. On September 16, 2004, the girls are separated. Tabea dies shortly thereafter.

Jade and Erin Buckles
Born February 26, 2004, to Melissa and Kevin Buckles at National Naval Medical Center in Bethesda, Maryland. They share a liver. On June 19, 2004, they are successfully separated.

Tatiana and Anastasia Dogaru
Born January 13, 2004, in Rome to Romanian parents Claudia and Alin Dogaru. They are connected at the head. In August 2007, doctors at University Hospital’s Rainbow Babies & Children’s Hospital in Cleveland announce that they will not perform a separation of the girls because the surgery is too risky.

Abbigail and Isabelle Carlsen
Born November 29, 2005, in Fargo, North Dakota, to Amy and Jesse Carlsen. They are joined at the abdomen and chest. On May 12, 2006, a team of 30 people, including 18 surgeons from various specialties at the Mayo Clinic in Rochester, Minnesota, perform a successful operation to separate the girls.

Regina and Renata Salinas Fierros
Born August 2, 2005, in Los Angeles to Sonia Fierros and Federico Salinas. Born facing each other and joined from the lower chest to the pelvis, they are fused in several places including the liver and genitals, and they share a large intestine. Regina is born with one kidney. On June 14, 2006, the twins are separated during a day-long surgery at Children’s Hospital Los Angeles.

Abygail and Madysen Fitterer
Born August 8, 2006, to Stacy and Suzy Fitterer from Bismarck, North Dakota. They are born joined at the abdomen and share a liver. On January 3, 2007, they are separated in a surgery at the Mayo Clinic.

Preslee Faith and Kylee Hope Wells
Born October 25, 2008, in Oklahoma City to Stevie Stewart and Kylie Wells. They are attached at the chest and are believed to be the first Native American conjoined twins. On January 19, 2009, they are separated at Children’s Hospital at OU Medical Center in Oklahoma City. On February 19, 2011, Preslee Faith dies.

Arthur and Heitor Rocha Brandao
Born April 2009 in Bahia, Brazil, to Eliane and Delson Rocha. They are joined at the hip and share a bladder, intestines, liver and genitals. The twins only have three legs between them. On February 24, 2015, the five-year-old twins undergo a 15-hour separation surgery after months of preparation. Arthur dies three days later after he suffers cardiac arrest.

Angelica and Angelina Sabuco
Born August 2009 in the Philippines to Fidel and Ginady Sabuco. They are joined at the chest and abdomen. On November 1, 2011, they are successfully separated after a 10-hour surgery at Lucile Packard Children’s Hospital in San Jose, California.

Hassan and Hussein Benhaffaf
Born December 2, 2009, in London to Angie and Azzedine Benhaffaf from East Cork, Ireland. They are attached at the chest but share no major organs. On April 8, 2010, they undergo a 14-hour separation surgery at Great Ormond Street Hospital. Both survive.

Maria and Teresa Tapia
Born April 8, 2010, in the Dominican Republic to Lisandra Sanatis and Marino Tapia. They are joined at the lower chest and abdomen and share a liver, pancreatic glands, and part of their small intestine. On November 8, 2011, they are successfully separated following a 20-hour procedure.

Joshua and Jacob Spates
Born January 24, 2011, in Memphis, Tennessee, to Adrienne Spates. They are joined back to back at the pelvis and lower spine, each with separate hearts, heads and limbs. On August 29, 2011, they are successfully separated after a 13-hour surgery. In October 2013, Jacob passes away.

Rital and Ritag Gaboura
Born September 22, 2010, in Khartoum, Sudan, to Abdelmajeed and Enas Gaboura. They are joined at the head. On August 15, 2011, they are successfully separated after a four-stage operation. Two operations took place in May, one in July and the final operation in August.

Allison June and Amelia Lee Tucker
Born March 1, 2012, to Shellie and Greg Tucker. They are attached at the lower chest and abdomen and share their chest wall, diaphragm, pericardium and liver. On November 7, 2012, they are successfully separated after a seven-hour surgery at Children’s Hospital Philadelphia.

A’zhari and A’zhiah Lawrence
Born October 10, 2012, in Virginia to Nachell Jones and Carlos Lawrence. They are joined from the chest to the abdomen and have a conjoined liver. On April 22, 2013, they are successfully separated following 14 hours of surgery. On October 14, 2013, A’zhari passes away.

Emmett and Owen Ezell
Born July 15, 2013, in Dallas to Jenni and Dave Ezell. They are joined at the liver and the intestine. On August 24, 2013, they are successfully separated.

Knatalye Hope and Adeline Faith Mata
Born April 11, 2014, in Houston to Elysse and John Matta. They are joined at the chest, sharing a liver, heart lining, diaphragm, intestines and colon. On February 17, 2015, a team of 12 surgeons separate the twins during a 26-hour procedure.

Erika and Eva Sandoval
Born August 10, 2014, in California to Aida and Arturo Sandoval. They are joined at the lower chest and upper abdomen and share a liver, bladder, two kidneys and three legs. On December 6-7, 2016, they are successfully separated after 17 hours of surgery at Lucile Packard Children’s Hospital Stanford in California.

Acen and Apio Akello
Born September 23, 2014, in Uganda to Ester Akello. They are joined at the hip and pelvis. On September 3, 2015, more than 30 medical specialists help separate the twins’ spinal cord during a 16-hour surgery at Nationwide Children’s Hospital in Ohio. To prepare for the surgery, medical specialists used 3-D printing to create anatomies similar to the girls.

Carter and Conner Mirabal
Born December 12, 2014, in Jacksonville, Florida, to Michelle Brantley and Bryan Mirabal. They are joined at the sternum and abdomen and share a liver and part of their small intestines. On May 7, 2015, the twins are successfully separated after 12 hours of surgery at Wolfson Children’s Hospital in Florida.

Scarlett and Ximena Torres
Born May 16, 2015, in Corpus Christi, Texas, to Silvia Hernandez and Raul Torres. Scarlett and Ximena are connected below the waist, sharing a colon and a bladder. On April 12, 2016, the twins are separated during a 12-hour procedure at the Driscoll Children’s Hospital in Texas.

Anias and Jadon McDonald
Born on September 9, 2015, in Chicago to Nicole and Christian McDonald. They are joined at the head. On October 13-14, 2016, Anias and Jadon are successfully separated after 27 hours of surgery at the Children’s Hospital at Montefiore Medical Center in New York.

Dawa and Nima Pelden
Born on July 13, 2017, in Bhutan to Bhumchu Zangmo. They are joined at the abdomen. On November 9, 2018, Dawa and Nima are successfully separated after a six-hour surgery at Melbourne Royal Children’s Hospital in Australia.

Safa and Marwa Ullah
Born January 7, 2017, in Pakistan to Zainab Bibi. They are joined at the head. On February 11, 2019, Safa and Marwa are successfully separated after 50 hours of surgery, that took place over a four month period, at London’s Great Ormond Street Hospital.

Ervina and Prefina Bangalo
Born June 29, 2018, in the Central African Republic to Ermine Nzutto. They share a skull and a majority of blood vessels. On June 5, 2020, the twins are successfully separated during an operation in Vatican City lasting 18 hours and involving 30 doctors and nurses.

Abigail and Micaela Bachinskiy
Born December 30, 2019, in Sacramento, California. The twins are joined at the head. On October 23-24, 2020, the twins are successfully separated during a 24-hour operation at UC Davis Children’s Hospital in Sacramento, California.

Siphosethu and Amahle Tyhalisi
Born January 30, 2021, in South Africa to Ntombikayise Tyhalisi. They are joined at the head. On February 24, 2021, the twins are successfully separated during an operation at Red Cross War Memorial Children’s Hospital in Cape Town.

Hassana and Hasina
Born in January 12, 2022 in Kaduna, Nigeria to Omar Rayano. They share an abdomen, pelvis, liver, intestines, urinary and reproductive system, and pelvic bones. On May 18, 2023 the twins are successfully separated during an operation at King Abdullah Specialized Children’s Hospital in Riyadh, Saudi Arabia.

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May 20, 2023

Opioid Crisis Fast Facts | CNN

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CNN
—

Here’s a look at the opioid crisis.

Experts say the United States is in the throes of an opioid epidemic. An estimated 9.2 million Americans aged 12 and older misused opioids in 2021, including 8.7 million prescription pain reliever abusers and 1.1 million heroin users.

Opioids are drugs formulated to replicate the pain-reducing properties of opium. Prescription painkillers like morphine, oxycodone and hydrocodone are opioids. Illegal drugs like heroin and illicitly made fentanyl are also opioids. The word “opioid” is derived from the word “opium.”

Nearly 110,000 people died of drug overdoses in 2022, and more than two-thirds of those deaths involved a synthetic opioid.

Overdose deaths have been on the rise for years in the United States, but surged amid the Covid-19 pandemic: Annual deaths were nearly 50% higher in 2021 than in 2019, CDC data shows.

Prescription opioid volumes peaked in 2011, with the equivalent of 240 billion milligrams of morphine prescribed, according to the market research firm, IQVIA Institute for Human Data Science.

Alabama, Arkansas, Louisiana and Tennessee had the highest opioid dispensing rates in 2020.

Opioids such as morphine and codeine are naturally derived from opium poppy plants more commonly grown in Asia, Central America and South America. Heroin is an illegal drug synthesized from morphine.

Hydrocodone and oxycodone are semi-synthetic opioids, manufactured in labs with natural and synthetic ingredients.

Fentanyl is a fully synthetic opioid, originally developed as a powerful anesthetic for surgery. It is also administered to alleviate severe pain associated with terminal illnesses like cancer. The drug is up to 100 times more powerful than morphine. Just a small dose can be deadly. Illicitly produced fentanyl has been a driving factor in the number of overdose deaths in recent years.

Methadone is another fully synthetic opioid. It is commonly dispensed to recovering heroin addicts to relieve the symptoms of withdrawal.

Opioids bind to receptors in the brain and spinal cord, disrupting pain signals. They also activate the reward areas of the brain by releasing the hormone dopamine, creating a feeling of euphoria or a “high.”

Opioid use disorder is the clinical term for opioid addiction or abuse.

People who become dependent on opioids may experience withdrawal symptoms when they stop using the medication. Dependence is often coupled with tolerance, meaning that users need to take increasingly larger doses for the same effect.

A drug called naloxone, available as an injection or a nasal spray, is used as a treatment for overdoses. It blocks or reverses the effects of opioids and is often carried by first responders.

More data on overdose deaths

The 21st Century Cures Act, passed in 2016, allocated $1 billion over two years in opioid crisis grants to states, providing funding for expanded treatment and prevention programs. In April 2017, Health and Human Services Secretary Tom Price announced the distribution of the first round of $485 million in grants to all 50 states and US territories.

In August 2017, Attorney General Jeff Sessions announced the launch of an Opioid Fraud and Abuse Detection Unit within the Department of Justice. The unit’s mission is to prosecute individuals who commit opioid-related health care fraud. The DOJ is also appointing US attorneys who will specialize in opioid health care fraud cases as part of a three-year pilot program in 12 jurisdictions nationwide.

On October 24, 2018, President Donald Trump signed opioid legislation into law. The SUPPORT for Patients and Communities Act includes provisions aimed at promoting research to find new drugs for pain management that will not be addictive. It also expands access to treatment for substance use disorders for Medicaid patients.

State legislatures have also introduced measures to regulate pain clinics and limit the quantity of opioids that doctors can dispense.

1861-1865 – During the Civil War, medics use morphine as a battlefield anesthetic. Many soldiers become dependent on the drug.

1898 – Heroin is first produced commercially by the Bayer Company. At the time, heroin is believed to be less habit-forming than morphine, so it is dispensed to individuals who are addicted to morphine.

1914 – Congress passes the Harrison Narcotics Act, which requires that doctors write prescriptions for narcotic drugs like opioids and cocaine. Importers, manufacturers and distributors of narcotics must register with the Treasury Department and pay taxes on products

1924 – The Anti-Heroin Act bans the production and sale of heroin in the United States.

1970 – The Controlled Substances Act becomes law. It creates groupings (or schedules) of drugs based on the potential for abuse. Heroin is a Schedule I drug while morphine, fentanyl, oxycodone (Percocet) and methadone are Schedule II. Hydrocodone (Vicodin) is originally a Schedule III medication. It is later recategorized as a Schedule II drug.

January 10, 1980 – A letter titled “Addiction Rare in Patients Treated with Narcotics” is published in the New England Journal of Medicine. It looks at incidences of painkiller addiction in a very specific population of hospitalized patients who were closely monitored. It becomes widely cited as proof that narcotics are a safe treatment for chronic pain.

1995 – OxyContin, a long-acting version of oxycodone that slowly releases the drug over 12 hours, is introduced and aggressively marketed as a safer pain pill by manufacturer, Purdue Pharma.

May 10, 2007 – Purdue Pharma pleads guilty for misleadingly advertising OxyContin as safer and less addictive than other opioids. The company and three executives are charged with “misleading and defrauding physicians and consumers.” Purdue and the executives agree to pay $634.5 million in criminal and civil fines.

2010 – FDA approves an “abuse-deterrent” formulation of OxyContin, to help curb abuse. However, people still find ways to abuse it.

May 20, 2015 – The DEA announces that it has arrested 280 people, including 22 doctors and pharmacists, after a 15-month sting operation centered on health care providers who dispense large amounts of opioids. The sting, dubbed Operation Pilluted, is the largest prescription drug bust in the history of the DEA.

March 18, 2016 – The CDC publishes guidelines for prescribing opioids for patients with chronic pain. Recommendations include prescribing over-the-counter pain relievers like acetaminophen and ibuprofen in lieu of opioids. Doctors are encouraged to promote exercise and behavioral treatments to help patients cope with pain.

March 29, 2017 – Trump signs an executive order calling for the establishment of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. New Jersey Governor Chris Christie is selected as the chairman of the group, with Trump’s son-in-law, Jared Kushner, as an adviser.

July 31, 2017 – After a delay, the White House panel examining the nation’s opioid epidemic releases its interim report, asking Trump to declare a national public health emergency to combat the ongoing crisis

September 22, 2017 – The pharmacy chain CVS announces that it will implement new restrictions on filling prescriptions for opioids, dispensing a limited seven-day supply to patients who are new to pain therapy.

November 1, 2017 – The opioid commission releases its final report. Its 56 recommendations include a proposal to establish nationwide drug courts that would place opioid addicts in treatment facilities rather than prison.

February 9, 2018 – A budget agreement signed by Trump authorizes $6 billion for opioid programs, with $3 billion allocated for 2018 and $3 billion allocated for 2019.

February 27, 2018 – Sessions announces a new opioid initiative: The Prescription Interdiction & Litigation (PIL) Task Force. The mission of the task force is to support local jurisdictions that have filed lawsuits against prescription drugmakers and distributors.

March 19, 2018 – The Trump administration outlines an initiative to stop opioid abuse. The three areas of concentration are law enforcement and interdiction; prevention and education via an ad campaign; and job-seeking assistance for individuals fighting addiction.

April 9, 2018 – The US surgeon general issues an advisory recommending that Americans carry the opioid overdose-reversing drug, naloxone. A surgeon general advisory is a rarely used tool to convey an urgent message. The last advisory issued by the surgeon general, more than a decade ago, focused on drinking during pregnancy.

May 1, 2018 – The Journal of the American Medical Association publishes a study that finds synthetic opioids like fentanyl caused about 46% of opioid deaths in 2016. That’s a three-fold increase compared with 2010, when synthetic opioids were involved in about 14% of opioid overdose deaths. It’s the first time that synthetic opioids surpassed prescription opioids and heroin as the primary cause of overdose fatalities.

May 30, 2018 – The journal Medical Care publishes a study that estimates the cost of medical care and substance abuse treatment for opioid addiction was $78.5 billion in 2013.

June 7, 2018 – The White House announces a new multimillion dollar public awareness advertising campaign to combat opioid addiction. The first four ads of the campaign are all based on true stories illustrating the extreme lengths young adults have gone to obtain the powerful drugs.

December 12, 2018 – According to the National Center for Health Statistics, fentanyl is now the most commonly used drug involved in drug overdoses. The rate of drug overdoses involving the synthetic opioid skyrocketed by about 113% each year from 2013 through 2016.

January 14, 2019 – The National Safety Council finds that, for the first time on record, the odds of dying from an opioid overdose in the United States are now greater than those of dying in a vehicle crash.

March 26, 2019 – Purdue Pharma agrees to pay a $270 million settlement to settle a historic lawsuit brought by the Oklahoma attorney general. The settlement will be used to fund addiction research and help cities and counties with the opioid crisis.

July 17, 2019 – The CDC releases preliminary data showing a 5.1% decline in drug overdoses during 2018. If the preliminary number is accurate, it would mark the first annual drop in overdose deaths in more than two decades.

August 26, 2019 – Oklahoma wins its case against Johnson & Johnson in the first major opioid lawsuit trial to be held in the United States. Cleveland County District Judge Thad Balkman orders Johnson & Johnson to pay $572 million for its role in the state’s opioid crisis. The penalty is later reduced to $465 million, due to a mathematical error made when calculating the judgment. In November 2021, the Oklahoma Supreme Court reverses the decision.

September 15, 2019 – Purdue files for bankruptcy as part of a $10 billion agreement to settle opioid lawsuits. According to a statement from the chair of Purdue’s board of directors, the money will be allocated to communities nationwide struggling to address the crisis.

September 30, 2019 – The FDA and DEA announce that they sent warnings to four online networks, operating a total of 10 websites, which the agencies said are illegally marketing unapproved and misbranded versions of opioid medicines, including tramadol.

February 25, 2020 – Mallinckrodt, a large opioid manufacturer, reaches a settlement agreement in principle worth $1.6 billion. Mallinckrodt says the proposed deal will resolve all opioid-related claims against the company and its subsidiaries if it moves forward. Plaintiffs would receive payments over an eight-year period to cover the costs of opioid-addition treatments and other needs.

October 21, 2020 – The Justice Department announces that Purdue Pharma, the maker of OxyContin, has agreed to plead guilty to three federal criminal charges for its role in creating the nation’s opioid crisis. They agree to pay more than $8 billion and close down the company. The money will go to opioid treatment and abatement programs. The Justice Department also reached a separate $225 million civil settlement with the former owners of Purdue Pharma, the Sackler family. In November 2020, Purdue Pharma board chairman Steve Miller formally pleads guilty on behalf of the company.

March 15, 2021 – According to court documents, Purdue files a restructuring plan to dissolve itself and establish a new company dedicated to programs designed to combat the opioid crisis. As part of the proposed plan, the Sackler family agrees to pay an additional $4.2 billion over the next nine years to resolve various civil claims.

September 1, 2021 – In federal bankruptcy court, Judge Robert Drain rules that Purdue Pharma will be dissolved. The settlement agreement resolves all civil litigation against the Sackler family members, Purdue Pharma and other related parties and entities, and awards them broad legal protection against future civil litigation. The Sacklers will relinquish control of family foundations with over $175 million in assets to the trustees of a National Opioid Abatement Trust. On December 16, 2021, a federal judge overturns the settlement.

February 25, 2022 – Johnson & Johnson and the three largest US drug distributors – McKesson Corp, Cardinal Health Inc and AmerisourceBergen Corp – finalize a $26 billion nationwide opioid settlement.

March 3, 2022 – The Sackler families reaches a settlement with a group of states the first week of March, according to court filings. The settlement, ordered through court-ordered mediation that began in January, requires the Sacklers to pay out as much as $6 billion to states, individual claimants and opioid crisis abatement, if approved by a federal bankruptcy court judge.

November 2, 2022 – CVS and Walgreens agree to pay a combined $10 billion, over 10 and 15 years, to settle lawsuits brought by states and local governments alleging the retailers mishandled prescriptions of opioid painkillers.

November 15, 2022 – Walmart agrees to the framework of a $3.1 billion settlement, which resolves allegations from multiple states’ attorneys general that the company failed to regulate opioid prescriptions contributing to the nationwide opioid crisis.

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May 18, 2023

When older parents resist help or advice, use these tips to cope | CNN

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KFF Health News
—

It was a regrettable mistake. But Kim Sylvester thought she was doing the right thing at the time.

Her 80-year-old mother, Harriet Burkel, had fallen at her home in Raleigh, North Carolina, fractured her pelvis and gone to a rehabilitation center to recover. It was only days after the death of Burkel’s husband, 82, who had moved into a memory care facility three years earlier.

With growing distress, Sylvester had watched her mother, who had emphysema and peripheral artery disease, become increasingly frail and isolated. “I would say, ‘Can I help you?’ And my mother would say, ‘No, I can do this myself. I don’t need anything. I can handle it,’ ” Sylvester told me.

Now, Sylvester had a chance to get some more information. She let herself into her mother’s home and went through all the paperwork she could find. “It was a shambles — completely disorganized, bills everywhere,” she said. “It was clear things were out of control.”

Sylvester sprang into action, terminating her mother’s orders for anti-aging supplements, canceling two car warranty insurance policies (Burkel wasn’t driving at that point), ending a yearlong contract for knee injections with a chiropractor and throwing out donation requests from dozens of organizations. When her mother found out, she was furious.

“I was trying to save my mother, but I became someone she couldn’t trust — the enemy,” Sylvester said. “I really messed up.”

Dealing with an older parent who stubbornly resists offers of help isn’t easy. But the solution isn’t to make an older person feel like you’re steamrolling them and taking over their affairs. What’s needed instead are respect, empathy and appreciation of the older person’s autonomy.

“It’s hard when you see an older person making poor choices and decisions. But if that person is cognitively intact, you can’t force them to do what you think they should do,” said Anne Sansevero, president of the board of directors of the Aging Life Care Association, a national organization of care managers who work with older adults and their families. “They have a right to make choices for themselves.”

That doesn’t mean adult children concerned about an older parent should step aside or agree to everything the parent proposes. Rather, a different set of skills is needed.

Cheryl Woodson, an author and retired physician based in the Chicago area, learned this firsthand when her mother — whom Woodson described as a “very powerful” woman — developed mild cognitive impairment. She started getting lost while driving and would buy things she didn’t need, then give them away.

Chastising her mother wasn’t going to work. “You can’t push people like my mother or try to take control,” Woodson said. “You don’t tell them, ‘No, you’re wrong,’ because they changed your diapers and they’ll always be your mom.”

Instead, Woodson learned to appeal to her mother’s pride in being the family matriarch. “Whenever she got upset, I’d ask her, ‘Mother, what year was it that Aunt Terri got married?’ or ‘Mother, I don’t remember how to make macaroni. How much cheese do you put in?’ And she’d forget what she was worked up about, and we’d just go on from there.”

Woodson, author of “To Survive Caregiving: A Daughter’s Experience, a Doctor’s Advice,” also learned to apply a “does it really matter to safety or health?” standard to her mother’s behavior. It helped Woodson let go of her sometimes unreasonable expectations.

One example she related: “My mother used to shake hot sauce on pancakes. It would drive my brother nuts, but she was eating, and that was good.”

“You don’t want to rub their nose into their incapacity,” said Woodson, whose mother died in 2003.

Barry Jacobs, a clinical psychologist and family therapist, sounded similar themes in describing a psychiatrist in his late 70s who didn’t like to bend to authority. After his wife died, the older man stopped shaving and changing his clothes regularly. Though he had diabetes, he didn’t want to see a physician and instead prescribed medicine for himself. Even after several strokes compromised his vision, he insisted on driving.

An adult child needs to show empathy and respect for the autonomy of an aging parent.

Jacobs’ take: “You don’t want to go toe-to-toe with someone like this, because you will lose. They’re almost daring you to tell them what to do so they can show you they won’t follow your advice.”

What’s the alternative? “I would employ empathy and appeal to this person’s pride as a basis for handling adversity or change,” Jacobs said. “I might say something along the lines of, ‘I know you don’t want to stop driving and that this will be very painful for you. But I know you have faced difficult, painful changes before and you’ll find your way through this.’ “

“You’re appealing to their ideal self rather than treating them as if they don’t have the right to make their own decisions anymore,” he said. In the older psychiatrist’s case, conflict with his four children was constant, but he eventually stopped driving.

Another strategy that can be useful: “Show up, but do it in a way that’s face-saving,” Jacobs said. Instead of asking your father if you can check in on him, “Go to his house and say, ‘The kids really wanted to see you. I hope you don’t mind.’ Or ‘We made too much food. I hope you don’t mind my bringing it over.’ Or ‘I wanted to stop by. I hope you can give me some advice about this issue that’s on my mind.’ “

This psychiatrist didn’t have any cognitive problems, though he wasn’t as sharp as he used to be. But encroaching cognitive impairment often colors difficult family interactions.

If you think this might be a factor with your parents, instead of trying to persuade them to accept more help at home, try to get them medically evaluated, said Leslie Kernisan, author of “When Your Aging Parent Needs Help: A Geriatrician’s Step-by-Step Guide to Memory Loss, Resistance, Safety Worries, and More.”

“Decreased brain function can affect an older adult’s insight and judgment and ability to understand the risks of certain actions or situations while also making people suspicious and defensive,” she noted.

This doesn’t mean you should give up on talking to an older parent with mild cognitive impairment or early-stage dementia, however. “You always want to give the older adult a chance to weigh in and talk about what’s important to them and their feelings and concerns,” Kernisan said.

“If you frame your suggestions as a way of helping your parent achieve a goal they’ve said was important, they tend to be much more receptive to it,” she said.

A turning point for Sylvester and her mother came when the older woman, who developed dementia, went to a nursing home at the end of 2021. Her mother, who at first didn’t realize the move was permanent, was furious, and Sylvester waited two months before visiting. When she finally walked into Burkel’s room, bearing a Valentine’s Day wreath, Burkel hugged her and said, “I’m so glad to see you,” before pulling away. “But I’m so mad at my other daughter.”

Sylvester, who doesn’t have a sister, responded, “I know, Mom. She meant well, but she didn’t handle things properly.” She learned the value of what she calls a “therapeutic fiblet” from Kernisan, who ran a family caregiver group Sylvester attended between 2019 and 2021.

After that visit, Sylvester saw her mother often, and all was well between the two women up until Burkel’s death. “If something was upsetting my mother, I would just go, ‘Interesting,’ or ‘That’s a thought.’ You have to give yourself time to remember this is not the person you used to know and create the person you need to be your parent, who’s changed so much.”

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May 14, 2023

Let us now praise single moms | CNN

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CNN
—

Roughly 24 million, or one-third of all American children under age 18, are living with an unmarried parent, according to a 2018 Pew Research Center analysis of US Census Bureau data. And 81% of those single parent homes are headed by a mom.

This has been a growing trend since the late 1960s. The number of kids being raised by mostly single moms has more than doubled between 1968 and 2017.

Yet despite growing up in the middle of this trend, in the 1970s and ’80s, when divorce was increasingly common and “Kramer vs. Kramer” felt like the documentary of our childhood, and despite being part of a generation of latchkey kids who came home from school while parents were still at work, I was, I confess, embarrassed to be raised by a single mom when I was growing up.

For the majority of my 12 years of Catholic school, I was the only student who lived with one parent. And for that reason, I was also, demonstratively, the poorest kid in my school. We lived off one paycheck, or paychecks when my mom held multiple jobs at once. The modest child support went to school tuition.

Like most kids, I didn’t want to be different. I wanted to be “normal.” “Why can’t we just be normal?” I’d often lament to my mom.

I was embarrassed by our car, which broke down; embarrassed that we didn’t seem to go anywhere for vacation; that I didn’t have brand-name clothes (thank God for school uniforms that greatly leveled the playing field); or video games; or cable TV; or anything else that my classmates had. I was embarrassed that my dad, who lived in a neighboring state, never came to any school events.

And I was teased for it. “Why don’t you get a new car?” “Your gym shoes are fake Nikes.” “Do you even have a dad?” I was often angry. I got into a lot of fights. When the principal’s office called home because I got into it with another kid, it was always my mom who had to come in.

Of course, my mother, like all parents, only added to that embarrassment. She was, and still is, artistically inclined and health-conscious. We went to museums and art stores instead of amusement parks and toy stores. I went to a summer camp run by cloistered monks … in heavy brown robes. My mom performed in community theater and sometimes roped me into bit parts. We went to clown school … together. At Christmas, I often got books and clothes. And my mom shopped for groceries at health food stores, which was much more unusual back then and involved a lot of bulk foods, homegrown sprouts and warm, freshly ground peanut butter. I had an all-carob Easter one year. I was embarrassed by my un-tradable school lunches and embarrassed at meals when friends spent the night.

Sitting under a framed movie poster of Richard Attenborough’s “Gandhi,” my friend would stare at an unappetizing breakfast bowl of “natural” cereal I poured for him out of a bulk food bag. His breath would blow a few rice puffs out of the bowl and across the table. “We can drizzle honey on it!” I’d say, as if that would solve everything. And then he’d go home to eat his Honeycomb or Count Chocula or whatever.

“Why can’t we just be normal?”

There has been a lot of research over the decades that has shown children of single parents report more family distress and conflict and live at a lower socioeconomic status compared to those growing up in two-parent households. Two-parent families usually have more income and are generally able to provide more emotional resources to children, and that’s also a reflection of how little the United States in general does to support working mothers with parental paid leave and access to more health services and quality education.

And of course, it’s difficult to compare single parenting outcomes to hypothetical alternatives. For many, a single mom can create a much safer or more stable environment than living with an abusive parent and spouse. Just growing up in an unhappy marriage has an effect on children.

A 2017 study, however, looked at the long-term effects of single parenthood on kids and found that it had nearly no impact on their general life satisfaction. The authors also found no evidence “supporting the widely held notion from popular science that boys are more affected than girls by the absence of their fathers.” What mattered most in terms of thriving, they concluded, was the quality and strength of the relationship between children and parents.

A separate 10-year study on single parenting that collected data from 40,000 households in the UK came to a similar conclusion last year. “There is no evidence of a negative impact of living in a single parent household on children’s wellbeing, with regard to self-reported life satisfaction, quality of peer relationships, or positivity about family life,” the report states. “Children who are living or have lived in single parent families score as highly, or higher, against each measure of wellbeing than those who have always lived in two parent families”

Speaking for myself, I’d go further and say there were benefits to being raised by a single mother, that it was foundational to becoming the adult I am now.

Being raised by a single parent required an Emersonian amount of self-reliance. I got myself to school in the morning, figured out how to apply to college, paid my way through that education and embarked on a career with no shortcuts or introductions. Our poverty made me class-conscious even as I earned my way into the middle class myself. My role model for what women are and should be was smart, strong, independent and deserving of all respect.

Even my childhood embarrassment was character-building, giving me a deeper sense of self-worth that is dependent neither on material things nor the opinion of those I don’t admire.

I’m not embarrassed now. Being raised by a single mother means the opposite to me today: I have a pride in her for enduring so much (including the indignity of a son perpetually embarrassed by our situation).

But even as a kid, I thought of her as a role model of resilience and resourcefulness. She imparted integrity, a love of the arts and a sense of occasion for the things I loved, like “Star Wars” and Orioles baseball. Before the age of 10, I was exposed to classical music, classic film, anti-nuclear activism, boxing (as participant) and yoga (long before it was a thing people did at gyms). And her exuberant creativity meant she was also a lot of fun growing up. We once invented a board game about the holidays of the world’s religions. On weekend mornings, we went to a park near a music conservancy to hear musicians practice while we ate our granola breakfast.

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Nothing about the financial and logistical stress of our years together kept her from raising a responsible, decent, curious, creative and accomplished son with very high life satisfaction. She gets more credit for that than any other individual, except maybe me. I’m not embarrassed, I’m grateful.

Let us now praise single mothers. All of them. The “weird” ones. The struggling ones. The driven ones who choose to parent alone. The widowed, who didn’t. The brave ones who divorced for the well-being of their kids and/or themselves. They are all raising about 19 million children right now, and they need all the support they can get.

This story was original published in October 2019. It has been updated.

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May 12, 2023

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

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CNN
—

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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May 10, 2023

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

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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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May 9, 2023

Covid-19 Pandemic Timeline Fast Facts | CNN

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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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May 8, 2023

Kids need to gain weight during adolescence. Here’s why | CNN

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Editor’s Note: Michelle Icard is the author of several books on raising adolescents, including “Fourteen Talks by Age Fourteen.”

CNN
—

I’ve worked with middle schoolers, their parents and their schools for 20 years to help kids navigate the always awkward, often painful, sometimes hilarious in hindsight, years of early adolescence.

Most of the social and development stretch marks we gain during adolescence fade to invisibility over time. We stop holding a grudge against the kid who teased us in class for tripping, or we forgive ourselves our bad haircuts, botched friendships and cringy attempts at popularity.

But one growing pain can be dangerously hard to recover from, and ironically, it’s the one that has most to do with our physical growth.

Children are supposed to keep growing in adolescence, and so a child’s changing body during that time should not be cause for concern. Yet it sends adults into a tailspin of fear around weight, health and self-esteem.

Kids have always worried about their changing bodies. With so many changes in such a short period of early puberty, they constantly evaluate themselves against each other to figure out if their body development is normal. “All these guys grew over the summer, but I’m still shorter than all the girls. Is something wrong with me?” “No one else needs a bra, but I do. Why am I so weird?”

But the worry has gotten worse over the past two decades. I’ve seen parents becoming increasingly worried about how their children’s bodies change during early puberty. When I give talks about parenting, I often hear adults express concern and fear about their children starting to gain “too much” weight during early adolescence.

Parents I work with worry that even kids who are physically active, engaged with others, bright and happy might need to lose weight because they are heavier than most of their peers.

Why are parents so focused on weight? In part, I think it’s because our national conversations about body image and disordered eating have reached a frenzy on the topic. Over the past year, two new angles have further complicated this matter for children.

Remember Jimmy Kimmel’s opening monologue at the Oscars making Ozempic and its weight-loss properties a household name? Whether it’s social media or the mainstream press, small bodies and weight loss are valued. It’s clear to young teens I know that celebrities have embraced a new way to shrink their bodies.

Constant messages about being thin and fit are in danger of overexposing kids to health and wellness ideals that are difficult to extract from actual health and wellness.

Compound this with the American Academy of Pediatrics recently changing its guidelines on treating overweight children, and many parents worry even more that saying or doing nothing about their child’s weight is harmful.

The opposite is true. Parents keep their children healthiest when they say nothing about their changing shape. Here’s why.

Other than the first year of life, we experience the most growth during adolescence. Between the ages of 13 and 18, most adolescents double their weight. Yet weight gain remains a sensitive, sometimes scary subject for parents who fear too much weight gain, too quickly.

It helps to understand what’s normal. On average, boys do most of their growing between 12 and 16. During those four years, they might grow an entire foot and gain as much as 50 to 60 pounds. Girls have their biggest growth spurt between 10 and 14. On average, they can gain 10 inches in height and 40 to 50 pounds during that time, according to growth charts from the US Centers for Disease Control and Prevention.

Boys do most of their growing between ages 12 and 16 on average. They may even grow an entire foot.

“It’s totally normal for kids to gain weight during puberty,” said Dr. Trish Hutchison, a board-certified pediatrician with 30 years of clinical experience and a spokesperson for the American Academy of Pediatrics, via email. “About 25 percent of growth in height occurs during this time so as youth grow taller, they’re also going to gain weight. Since the age of two or three, children grow an average of about two inches and gain about five pounds a year. But when puberty hits, that usually doubles.”

The American Academy of Pediatrics released a revised set of guidelines for pediatricians in January, which included recommendations of medications and surgery for some children who measure in the obese range.

In contrast, its 2016 guidelines talked about eating disorder prevention and “encouraged pediatricians and parents not to focus on dieting, not to focus on weight, but to focus on health-promoting behaviors,” said Elizabeth Davenport, a registered dietitian in Washington, DC.

“The new guidelines are making weight the focus of health,” she said. “And as we know there are many other measures of health.”

Davenport said she worries that kids could misunderstand their pediatricians’ discussions about weight, internalize incorrect information and turn to disordered eating.

“A kid could certainly interpret that message as not needing to eat as much or there’s something wrong with my body and that leads down a very dangerous path,” she said. “What someone could take away is ‘I need to be on a diet’ and what we know is that dieting increases the risk of developing an eating disorder.”

Many tweens have tried dieting, and many parents have put their kids on diets.

“Some current statistics show that 51% of 10-year-old girls have tried a diet and 37% of parents admit to having placed their child on a diet,” Hutchison said in an email, adding that dieting could be a concern with the new American Academy of Pediatrics guidelines.

“There is evidence that having conversations about obesity can facilitate effective treatment, but the family’s wishes should strongly direct when these conversations should occur,” Hutchison said. “The psychological impact may be more damaging than the physical health risks.”

It’s not that weight isn’t important. “For kids and teens, we need to know what their weight is,” Davenport said. “We are not, as dietitians, against kids being weighed because it is a measure to see how they’re growing. If there’s anything outstanding on an adolescent’s growth curve, that means we want to take a look at what’s going on. But we don’t need to discuss weight in front of them.”

In other words, weight is data. It may or may not indicate something needs addressing. The biggest concern, according to Davenport, is when a child isn’t gaining weight. That’s a red flag something unhealthy is going on.

“Obesity is no longer a disease caused by energy in/energy out,” Hutchison said. “It is much more complex and other factors like genetics, physiological, socioeconomic, and environmental contributors play a role.”

It’s important for parents and caregivers to know that “the presence of obesity or overweight is NOT an indication of poor parenting,” she said. “And it’s not the child or adolescent’s fault.”

It’s also key to note, Hutchison said, that the new American Academy of Pediatrics guidelines, which are only recommendations, are not for parents. They are part of a 100-page document that provides information to health care providers with clinical practice guidelines for the evaluation and treatment of children and adolescents who are overweight or obese. Medications and surgery are discussed in only four pages of the document.

Parents need to work on their own weight bias, but they also need to protect their children from providers who don’t know how to communicate with their patients about weight.

“Working in the field of eating disorder treatment for over 20 years, I sadly can’t tell you the number of clients who’ve come in and part of the trigger for their eating disorder was hearing from a medical provider that there was an issue or a concern of some sort with their weight,” Davenport said.

Hutchison said doctors and other health providers need to do better.

“We all have a lot of work to do when it comes to conversations about weight,” Hutchison said. “We need to approach each child with respect and without (judgment) because we don’t want kids to ever think there is something wrong with their body.”

The right approach, according to American Academy of Pediatrics training, is to ask parents questions that don’t use the word “weight.” One example Hutchison offered: “What concerns, if any, do you have about your child’s growth and health?”

Working sensitively, Hutchison said she feels doctors can have a positive impact on kids who need or want guidance toward health-promoting behaviors.

Kids can misunderstand doctors' discussions about their weight and internalize incorrect information.

Davenport and her business partner in Sunny Side Up Nutrition, with input from the Carolina Resource Center for Eating Disorders, have gotten more specific. They have created a resource called Navigating Pediatric Care to give parents steps they can take to ask health care providers to discuss weight only with them — not with children.

“Pediatricians are supposed to ask permission to be able to discuss weight in front of children,” Davenport said. “It’s a parent’s right to ask this and advocate for their child.”

Davenport advises parents to call ahead and schedule an appointment to discuss weight before bringing in a child for a visit. She also suggests calling or emailing ahead with your wishes, though she admits it may be less effective in a busy setting. She said to print out a small card to hand to the nurse and physician at the appointment. You can also say in front of the child, “We prefer not to discuss weight in front of my child.”

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