Vaccines Fast Facts | CNN



CNN
 — 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Conjoined Twins Fast Facts | CNN



CNN
 — 

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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Opioid Crisis Fast Facts | CNN



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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Concern grows around US health-care workforce shortage: ‘We don’t have enough doctors’ | CNN



CNN
 — 

There is mounting concern among some US lawmakers about the nation’s ongoing shortage of health-care workers, and the leaders of historically Black medical schools are calling for more funding to train a more diverse workforce.

As of Monday, in areas where a health workforce shortage has been identified, the United States needs more than 17,000 additional primary care practitioners, 12,000 dental health practitioners and 8,200 mental health practitioners, according to data from the Health Resources & Services Administration. Those numbers are based on data that HRSA receives from state offices and health departments.

“We have nowhere near the kind of workforce, health-care workforce, that we need,” Vermont Sen. Bernie Sanders told CNN on Friday. “We don’t have enough doctors. We don’t have enough nurses. We don’t have enough psychologists or counselors for addiction. We don’t have enough pharmacists.”

The heads of historically Black medical schools met with Sanders in a roundtable at the Morehouse School of Medicine in Atlanta on Friday to discuss the nation’s health-care workforce shortage.

The health-care workforce shortage is “more acute” in Black and brown communities; the Black community constitutes 13% of the US population, but only 5.7% of US physicians are Black, said Sanders, chairman of the Senate Committee on Health, Education, Labor, and Pensions.

“What we’re trying to do in this committee – in our Health, Education, Labor Committee – is grow the health-care workforce and put a special emphasis on the needs to grow more Black doctors, nurses, psychologists, et cetera,” Sanders said.

At Friday’s roundtable, the leaders of the Morehouse School of Medicine, Meharry Medical College, Howard University and Charles R. Drew University called for more resources and opportunities to be allocated to their institutions to help grow the nation’s incoming health-care workforce.

“Allocating resources and opportunities matter for us to increase capacity and scholarships and programming to help support these students as they matriculate through,” Dr. Valerie Montgomery Rice, president of the Morehouse School of Medicine, told CNN.

“But also, the other 150-plus medical schools, beyond our four historically Black medical schools, owe it to the country to increase the diversity of the students that they train,” Rice said, adding that having a health-care workforce that reflects the communities served helps reduce the health inequities seen in the United States.

Historically Black medical schools are “the backbone for training Black doctors in this country,” Dr. Hugh Mighty, senior vice president for health affairs at Howard University, said at Friday’s event. “As the problem of Black physician shortages rise, within the general context of the physician workforce shortage, many communities of need will continue to be underserved.”

A new study commissioned by the National Institute on Minority Health and Health Disparities estimates that the economic burden of health inequities in the United States has cost the nation billions of dollars. Such inequities are illustrated in how Black and brown communities tend to have higher rates of serious health outcomes such as maternal deaths, certain chronic diseases and infectious diseases.

The researchers, from Johns Hopkins University and other institutions, analyzed excess medical care expenditures, death records and other US data from 2016 through 2019. They took a close look at health inequities in the cost of medical care, differences in premature deaths and the amount of labor market productivity that has been lost due to health reasons.

The researchers found that, in 2018, the economic burden of health inequities for racial and ethnic minority communities in the United States was up to $451 billion, and the economic burden of health inequities for adults without a four-year college degree was up to $978 billion.

“These findings provide a clear and important message to health care leaders, public health officials, and state and federal policy makers – the economic magnitude of health inequities in the US is startlingly high,” Drs. Rishi Wadhera and Issa Dahabreh, both of Harvard University, wrote in an editorial that accompanied the new study in the journal JAMA.

The Covid-19 pandemic “pulled the curtain back” on health inequities, such as premature death and others, Rice said, and “we saw a disproportionate burden” on some communities.

“We saw a higher death rate in Black and brown communities because of access and fear and a whole bunch of other factors, including what we recognize as racism and unconscious bias,” Rice said.

“We needed more physicians, more health-care providers. So, we already know when we project out to 2050, we have a significant physician shortage based on the fact that we cannot educate and train enough health care professionals fast enough,” she said. “We can’t just rely on physicians. We have to rely on a team approach.”

She added that the nation’s shortage of health-care workers leaves the country ill-prepared to respond to future pandemics.

The United States is projected to face a shortage of up to 124,000 physicians by 2034 as the demand outpaces supply, according to the Association of American Medical Colleges.

The workforce shortage means “we’re really not prepared” for another pandemic, Sanders said.

“We don’t have the public health infrastructure that we need state by state. We surely don’t have the doctors and the nurses that we need,” Sanders said. “So what we are trying to do now is to bring forth legislation, which will create more doctors and more nurses, more dentists, because dental care is a major crisis in America.”

In March, Bill McBride, executive director of the National Governors Association, wrote a letter to Sanders and Louisiana Sen. Bill Cassidy detailing the “root causes” of the health-care workforce shortage and potential ways some states are hoping to tackle the crisis.

“Governors have taken innovative steps to address the healthcare workforce shortage facing their states and territories by boosting recruitment efforts, loosening licensing requirements, expanding training programs and raising providers’ pay,” McBride wrote.

“Shortages in healthcare workers is not a new challenge but has only worsened in the past three years due to the COVID-19 pandemic. Burnout and stress have only exacerbated this issue,” he wrote. “The retirement and aging of an entire generation is front and center of the healthcare workforce shortage, particularly impacting rural communities.”

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Covid-19 is no longer a public health emergency, but others remain | CNN



CNN
 — 

The Covid-19 pandemic hit a major milestone this month as public health emergency declarations were ended by both the United States government and the World Health Organization. Emergency declarations for mpox also recently ended.

This doesn’t mean Covid-19 and mpox are no longer of concern, but it does mark the end of the availability of certain logistical capabilities to manage them.

Still, other critical health challenges were identified as health emergencies years before the start of the Covid-19 pandemic and continue to be so: the opioid crisis in the US and the global spread of poliovirus.

Some public health concerns can be serious health threats without a formal emergency declaration, said Dr. Tom Frieden, former director of the US Centers for Disease Control and Prevention.

It largely boils down to the logistics of government operations.

“When there’s an unusual situation that requires multiple parts of an agency or multiple parts of the government or multiple parts of society to come together and coordinate, collaborate and work efficiently, then an emergency declaration can be a useful tool,” said Frieden, president and CEO of Resolve to Save Lives, an organization focused on global epidemic prevention and cardiovascular health.

“Sometimes, an emergency is declared to make the point that it’s a big problem, to get people’s attention. Sometimes, an emergency is declared to get things done because that’s the only way you can bring certain governmental capacities to bear.”

According to WHO, a public health emergency of international concern is “an extraordinary event” that poses public health risk through the international spread of disease.

It creates an agreement between countries to abide by WHO’s recommendations for managing the emergency, often requiring a “coordinated international response.” Each country, in turn, declares its own public health emergency – declarations that carry legal weight. Countries use them to marshal resources and waive rules in order to ease a crisis.

In the US, the secretary of the Department of Health and Human Services can declare a public health emergency for diseases or disorders that pose a threat, including “significant outbreaks” of an infectious disease, bioterrorist attacks or otherwise.

This triggers the availability of a set of resources and actions for the federal government, such as additional funds and data and reporting requirements.

Emergency declarations typically last up to 90 days, with formal renewal required as necessary every three months after that.

The opioid crisis was determined to be a public health emergency in October 2017, during the Trump administration, driven by the rising rates of opioid-related deaths and opioid use disorder.

The declaration has been renewed for more than five years, most recently at the end of March.

According to the CDC, the opioid epidemic started in 1999 with a rise in prescription opioid overdose deaths. Deaths started to increase precipitously as synthetic opioids – particularly fentanyl – started to take over in 2013.

In 2021, overdose deaths reached record levels in the US, and about three-quarters – more than 80,000 deaths – involved opioids.

Within the first year of the opioid emergency declaration, HHS used expanded authorities to field a survey about treatment for opioid use disorder among providers and to expedite research on the topic.

Public health emergencies are also declared to help with recovery after natural disasters, most recently for severe storms that hit Mississippi in March.

However, the Government Accountability Office considers both federal management of the public health emergency system and efforts to combat drug misuse to be “high-risk” areas that are vulnerable or in need of broad reform.

In a recent report, the federal watchdog group said that it has found “persistent deficiencies in HHS’s leadership role preparing for and responding to public health emergencies” and no demonstrated progress in federal agencies’ actions to address drug misuse.

WHO has considered poliovirus a public health emergency of international concern since 2014.

A committee formed to address the emergency reviewed the most recent data on cases and spread this month and voted unanimously that ongoing risks merited an extension of the emergency declaration, which the director-general formalized Friday.

The committee was “encouraged by reported progress” but says that risks remain high for factors including weak vaccination rates that could have been affected by the Covid-19 pandemic.

WHO identified seven counties with potential risk for international spread. And the US is among a group of 37 countries with recently detected cases.

In July, a polio case identified in New York became the first in the US in nearly a decade. The identified case, along with several positive wastewater tests in nearby communities, met WHO criteria to consider the US a country with circulating poliovirus.

Experts warned that it could just be the “tip of the iceberg,” with hundreds of cases spreading silently.

Childhood vaccination rates in the US dropped during the Covid-19 pandemic. A CDC report found that about 93% of kindergarteners enrolled in the 2021-22 school year got the required vaccines, including measles, mumps and rubella (MMR); diphtheria, tetanus and acellular pertussis (DTaP); and polio. Coverage fell for the second year in a row amid the pandemic, from about 94% the previous year and below the federal target of 95%.

While no longer under a formal emergency declaration, Covid-19 continues to be part of the “landscape of health threats,” Frieden said.

But the efficiency and coordination that the formal declaration helps facilitate should always be the goal.

“I think there are really important lessons from Covid, including the need to have a much more resilient public health system so that we can find problems quickly and implement effective solutions quickly,” Frieden said.

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How the nursing shortage may lead to gaps in sexual assault care | CNN


Missoula, Montana
KFF Health News
 — 

Jacqueline Towarnicki got a text as she finished her day shift at a local clinic. She had a new case, a patient covered in bruises who couldn’t remember how the injuries got there.

Towarnicki’s breath caught, a familiar feeling after four years of working night shifts as a sexual assault nurse examiner in this northwestern Montana city.

“You almost want to curse,” Towarnicki, 38, said. “You’re like, ‘Oh, no, it’s happening.’”

These nights on duty are Towarnicki’s second job. She’s on call once a week and a weekend a month. A survivor may need protection against sexually transmitted infections, medicine to avoid getting pregnant, or evidence collected to prosecute their attacker. Or all the above.

When her phone rings, it’s typically in the middle of the night. Towarnicki tiptoes down the stairs of her home to avoid waking her young son, as her half-asleep husband whispers encouragement into the dark.

Her breath is steady by the time she changes into the clothes she laid out close to her back door before going to bed. She grabs her nurse’s badge and drives to First Step Resource Center, a clinic that offers round-the-clock care for people who have been assaulted.

She wants her patients to know they’re out of danger.

“You meet people in some of their most horrifying, darkest, terrifying times,” Towarnicki said. “Being with them and then seeing who they are when they leave, you don’t get that doing any other job in health care.”

A former travel nurse who lived out of a van for years, Towarnicki is OK with the uncertainty that comes with being a sexual assault nurse examiner.

Most examiners work on-call shifts in addition to full-time jobs. They often work alone and at odd hours. They can collect evidence that could be used in court, are trained to recognize and respond to trauma, and provide care to protect their patients’ bodies from lasting effects of sexual assault.

But their numbers are few.

As many as 80% of U.S. hospitals don’t have sexual assault nurse examiners, often because they either can’t find them or can’t afford them. Nurses struggle to find time for shifts, especially when staffing shortages mean covering long hours. Sexual assault survivors may have to leave their town or even their state to see an examiner.

Gaps in sexual assault care can span hundreds of miles in rural areas. A program in Glendive, Montana — a town of nearly 5,000 residents 35 miles from the North Dakota border — stopped taking patients for examinations this spring. It didn’t have enough nurses to respond to cases.

“These are the same nurses working in the ER, where a heart attack patient could come in,” said Teresea Olson, 56, who is the town’s part-time mayor and also picked up on-call shifts. “The staff was exhausted.”

The next closest option is 75 miles away in Miles City, adding at least an hour to the travel time for patients, some of whom already had to travel hours to reach Glendive.

Nationwide, policymakers have been slow to offer training, funding, and support for the work. Some states and health facilities are trying to expand access to sexual assault response programs.

Oklahoma lawmakers are considering a bill to hire a statewide sexual assault coordinator tasked with expanding training and recruiting workers. A Montana law that takes effect July 1 will create a sexual assault response network within the Montana Department of Justice. The new program aims to set standards for that care, provide in-state training, and connect examiners statewide. It will also look at telehealth to fill in gaps, following the example of hospitals in South Dakota and Colorado.

There’s no national tally of where nurses have been trained to respond to sexual assaults, meaning a survivor may not know they have to travel for treatment until they’re sitting in an emergency room or police department.

Sarah Wangerin, a nursing instructor with Montana State University and former examiner, said patients reeling from an attack may instead just go home. For some, leaving town isn’t an option.

This spring, Wangerin called county hospitals and sheriff’s offices to map where sexual assault nurse examiners operate in Montana. She found only 55. More than half of the 45 counties that responded didn’t have any examiners. Just seven counties reported they had nurses trained to respond to cases that involve children.

“We’re failing people,” Wangerin said. “We’re re-traumatizing them by not knowing what to do.”

First Step, in Missoula, is one of the few full-time sexual assault response programs in the state. It’s operated by Providence St. Patrick Hospital but is separate from the main building.

The clinic’s walls are adorned with drawings by kids and mountain landscapes. The staff doesn’t turn on the harsh overhead fluorescent lights, choosing instead to light the space with softer lamps. The lobby includes couches and a rocking chair. There are always heated blankets and snacks on hand.

Kate Harrison turns on her pager at the start of her night shift as a sexual assualt nurse examiner.

First Step stands out for having nurses who stay. Kate Harrison waited roughly a year to join the clinic and is still there three years later, in part because of the staff support.

The specially trained team works together so no one carries too heavy a load. While being on night shift means opening the clinic alone, staffers can debrief tough cases together. They attend group therapy for secondhand trauma.

Harrison is a cardiac hospital nurse during the day, a job that sometimes feels a little too stuck to a clock.

At First Step, she can shift into whatever role her patient needs for as long as they need. Once, that meant sitting for hours on a floor in the lobby of the clinic as a patient cried and talked. Another time, Harrison doubled as a DJ for a nervous patient during an exam, picking music off her cellphone.

“It’s in the middle of the night, she just had this sexual assault happen, and we were just laughing and singing to Shaggy,” Harrison said. “You have this freedom and grace to do that.”

When the solo work is overwhelming or she’s had back-to-back cases and needs a break, she knows a co-worker would be willing to help.

“This work can take you to the undercurrents and the underbelly of society sometimes,” Harrison said. “It takes a team.”

That includes co-workers like Towarnicki, who dropped her work hours at her day job after having her son to keep working as a sexual assault nurse examiner. That meant adding three years to her student loan repayment schedule. Now, pregnant with her second child, the work still feels worth it, she said.

On a recent night, Towarnicki was alone in the clinic, clicking through photos she took of her last patient. The patient opted against filing a police report but asked Towarnicki to log all the evidence just in case.

Towarnicki quietly counted out loud the number of bruises, their sizes and locations, as she took notes. She tells patients who have gaps in their memories that she can’t speculate how each mark got there or give them all the answers they deserve.

But as she sat in the blue light of her computer screen long after her patient left, it was hard to keep from ruminating.

“Totally looks like a hand mark,” Towarnicki said, suddenly loud, as she shook her head.

All the evidence and her patient’s story were sealed and locked away, just feet from a wall of thank-you cards from patients and sticky notes of encouragement among nurses.

On the harder evenings, Towarnicki takes a moment to unwind with a pudding cup from the clinic’s snacks. Most often, she can let go of her patient’s story as she closes the clinic. Part of her healing is “seeing the light returned to people’s eyes, seeing them be able to breathe deeper,” which she said happens 19 out of 20 times.

“There is that one out of 20 where I go home and I am spinning,” Towarnicki said. In those cases, it takes hearing her son’s voice, and time to process, to pull her back. “I feel like if it’s not hard sometimes, maybe you shouldn’t be doing this work.”

It was a little after 11 p.m. as Towarnicki headed home, an early night. She knew her phone could go off again.

Eight more hours on call.

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Mpox in the United States Fast Facts | CNN

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



CNN
 — 

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

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

(Source: Centers for Disease Control and Prevention)

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

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

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

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

CDC Mpox Map and Case Count

WHO Situation Reports

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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



CNN
 — 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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



CNN
 — 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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



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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