What is stiff person syndrome, the condition Celine Dion is battling? | CNN



CNN
— 

Complications from stiff person syndrome, a rare neurological condition that causes spasms and muscle rigidity, have caused singer Celine Dion to cancel her “Courage World Tour” dates through 2024, according to a statement posted Friday on the star’s social media account.

Dion postponed several performances in December after learning the reason for her muscle pain and difficulties with mobility. “While we’re still learning about this rare condition, we now know this is what’s been causing all of the spasms that I’ve been having,” Dion said at the time.

Despite undergoing daily physical therapy, “she is in a lot of pain,” a source close to Dion told CNN.

In the Instagram announcement of the tour’s cancellation, Dion is quoted as saying: “I’m so sorry to disappoint all of you once again. I’m working really hard to build back my strength, but touring can be very difficult even when you’re 100%.

“It’s not fair to you to keep postponing the shows, and even though it breaks my heart, it’s best that we cancel everything now until I’m really ready to be back on stage again. I want you all to know, I’m not giving up… and I can’t wait to see you again!”

Stiff person syndrome is characterized by muscle rigidity and spasms, heightened sensitivity to stimuli such as sound and lights, and emotional distress that can cause muscle spasms, according to the National Institute of Neurological Disorders and Stroke. Over time people with the condition can develop “hunched over postures,” the NINDS said.

The condition typically begins with muscle stiffness in the middle part of the body, the trunk and abdomen, before advancing to stiffness and spasms in the legs and other muscles, according to the Cleveland Clinic.

The muscle spasms can be “quite severe. These can cause falls, severe pain and significant disability,” said Dr. Emile Sami Moukheiber of the Stiff Person Syndrome Center at Johns Hopkins Medicine. “Falls from severe spasms are very common. These spasms can be precipitated by startle, severe emotions, cold weather.”

These spasms can be strong enough to fracture bone, and any fall can lead to severe injury.

Dion said in her December Instagram video that spasms affect “every aspect” of her daily life, “sometimes causing difficulties when I walk and not allowing me to use my vocal cords to sing the way I’m used to. It hurts me to tell you this today.”

The syndrome can also cause anxiety.

“Many patients, if not all, have an anxiety that is intrinsic to the disease and that anxiety actually feeds on the physical ailments of the disease that people can have,” Dr. Scott Newsome, director of the Stiff Person Syndrome Center, said in a video on the organization’s website.

At times, people with stiff person syndrome may be afraid to leave their homes because “street noises, such as the sound of a car horn, can trigger spasms and falls,” the NINDS noted.

Stiff person syndrome is very rare. About 1 out of every 1 million people have the syndrome, and most general neurologists will see only one or two cases in their lifetimes, Moukheiber said.

The first case of stiff person syndrome was reported in the 1950s, according to Newsome, and the disease was historically referred to as “stiff man syndrome.”

Since then, it has been found to affect twice as many women as men, and the name was changed to stiff person syndrome to avoid confusion.

The condition can develop at any age, but symptoms most often begin in a person’s 30s or 40s, according to the Cleveland Clinic.

Stiff person syndrome is thought to have features of an autoimmune disease, according to the National Institute of Neurological Disorders and Stroke: “It is frequently associated with other autoimmune diseases such as type-I diabetes, thyroiditis, vitiligo, and pernicious anemia.”

Although the exact cause isn’t clear, according to the institute, research shows it may be due to an autoimmune response “gone awry” in the brain and spinal cord.

“People with SPS have elevated levels of GAD, an antibody that works against an enzyme involved in the synthesis of an important neurotransmitter in the brain,” the institute noted on its website. “A definitive diagnosis can be made with a blood test that measures the level of glutamic acid decarboxylase (GAD) antibodies.”

Other tests include an electromyography (EMG), which measures electrical activity in the muscles, and a lumbar puncture, commonly called a spinal tap.

Because of the rarity of the disease and the ambiguity of its symptoms, people will often seek care for chronic pain before they get neurological care. The condition can be misdiagnosed as anxiety, fibromyalgia, multiple sclerosis, Parkinson’s disease, psychosomatic illness or even a phobia, the NINDS noted.

On average, it takes about seven years for someone to receive a diagnosis of stiff person syndrome, Newsome says.

“Sometimes, [patients] get labeled crazy,” he said, “because on exam early on, there aren’t the hallmark features of stiff person syndrome.”

There is no known cure for stiff person syndrome, but medications can ease the symptoms. Immunoglobulin medications can help lower sensitivity to light or sound triggers, potentially helping head off falls or spasms.

Pain relievers, anti-anxiety medications and muscle relaxers can be a part of treatment for this disease. The Stiff Person Syndrome Center also uses botulinum toxin injections.

Additional benefits may come from the use of acupuncture, physical therapy, heat and water therapy, the Cleveland Clinic noted.

“If left untreated, the disease can cause severe impairment of daily living,” Moukheiber said.

Dion, who previously said she has struggled with her health for a while, said she has a great team of medical professionals and her children’s support.

“I’m working hard with my sports medicine therapist every day to build back my strength and my ability to perform again,” she said. “But I have to admit it’s been a struggle.”

For a performer like Dion, loud noises and bright lights could act as triggers of muscle spasms.

“This is a very challenging illness that might take a toll on her if it is not treated aggressively, timely and appropriately,” Moukheiber said.



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HIV/AIDS Fast Facts | CNN



CNN
— 

Here’s a look at the origins, treatments and global response to HIV and AIDS.

HIV stands for human immunodeficiency virus.

AIDS stands for acquired immunodeficiency syndrome.

HIV/AIDS is spread through sexual contact with an infected person, sharing needles with an infected person, through transfusions of infected blood or through an infected mother.

People infected with HIV go through three stages of infection:

  1. Acute infection, or acute retroviral syndrome, which can produce flu-like symptoms in the first month after infection.
  2. Clinical latency, or asymptomatic HIV infection, in which HIV reproduces at lower levels.
  3. AIDS, in which the amount of CD4 cells fall below 200 cells per cubic millimeter of blood (as opposed to the normal level of 500-1,500).

HIV-1 and HIV-2 can both cause AIDS. HIV-1 is the most common human immunodeficiency virus; HIV-2 is found mostly in western Africa.

Antiretroviral therapy (ART) involves taking a cocktail of HIV medications used to treat the virus. In 1987, Azidothymidine (AZT) became the first FDA-approved drug used to attempt to treat HIV/AIDS.

from UNAIDS:

38.4 million – Number of people living with HIV/AIDS worldwide in 2021.

5.9 million – Approximate number of people living with HIV globally that are unaware of their HIV-positive status in 2021.

160,000 – Newly infected children worldwide in 2021.

1.5 million – New infections worldwide in 2021.

650,000 – Approximate number of AIDS-related deaths worldwide in 2021.

Of the 4,500 new infections each day in 2019, 59% are in sub-Saharan Africa.

40.1 million – Approximate number of AIDS-related deaths worldwide since the start of the epidemic.

Sub-Saharan Africa is comprised of the following countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Democratic Republic of the Congo, Ivory Coast, Djibouti, Equatorial Guinea, Eritrea, Ethiopia, Gabon, The Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Republic of the Congo, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, Sudan, South Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia and Zimbabwe.

1981 The Centers for Disease Control and Prevention (CDC) publish the first reports of men in Los Angeles, New York and San Francisco who were previously healthy and are suffering from rare forms of cancer and pneumonia, accompanied by “opportunistic infections.”

1982 The CDC refer to the disease as AIDS for the first time.

1983 French and American researchers determine that AIDS is caused by HIV.

1985 Blood tests to detect HIV are developed.

December 1, 1988 – First World AIDS Day.

1999 Researchers in the United States find evidence that HIV-1 most likely originated in a population of chimpanzees in West Africa. The virus appears to have been transmitted to people who hunted, butchered and consumed the chimpanzees for food.

January 29, 2003 In his State of the Union speech, US President George W. Bush promises to dramatically increase funding to fight HIV/AIDS in Africa.

May 27, 2003 – Bush signs H.R. 1298, the US Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003, also known as PEPFAR (US President’s Emergency Plan for AIDS Relief), that provides $15 billion over the next five years to fight HIV/AIDS, tuberculosis and malaria abroad, particularly in Africa.

July 30, 2008 H.R. 5501, The Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, becomes law and authorizes up to $48 billion to combat global HIV/AIDS, tuberculosis and malaria. Through 2013, PEPFAR plans to work in partnership with host nations to support treatment for at least four million people, prevention of 12 million new infections and care for 12 million people.

October 2011 – In his book, “The Origins of AIDS,” Dr. Jacques Pepin traces the emergence and subsequent development of HIV/AIDS to suggest that initial AIDS outbreaks began earlier than previously believed.

July 24, 2012 – Doctors announce during the 19th International AIDS Conference that Timothy Ray Brown, known as the “Berlin patient,” has been clinically “cured” of HIV. Brown, diagnosed with leukemia, underwent a bone marrow transplant in 2007 using marrow from a donor with an HIV-resistant mutation. He no longer has detectable HIV.

March 3, 2013 Researchers announce that a baby born infected with HIV has been “functionally cured.” The child, born in Mississippi, was given high doses of antiretroviral drugs within 30 hours of being born. A year later, the child now has detectable levels of the virus in her blood, 27 months after being taken off antiretroviral drugs, according to scientists involved with her case.

June 18, 2013 Marking the 10th anniversary of PEPFAR, Secretary of State John Kerry announces that the millionth child has been born HIV-free due to prevention of mother-to-child transmission programs (PMTCT).

March 14, 2014 – The CDC reports on a case of likely female-to-female HIV transmission. Unlike previous announcements of other cases involving female-to-female transmission, this case excludes additional risk factors for HIV transmission.

July 24, 2017 – A 9-year-old child from South Africa is reported to have been in remission for over eight years without treatment, according to Dr. Avy Violari, who spoke at the 9th International AIDS Society Conference on HIV Science in Paris.

November 2018 – According to PEPFAR’s website, they have “supported life-saving antiretroviral treatment (ART) for more than 14.6 million men, women and children” since 2003.

March 5, 2019 – According to a case study published in the journal Nature, a second person has sustained remission from HIV-1. The “London patient” was treated with stem cell transplants from donors with an HIV-resistant mutation. The London patient has been in remission for 18 months since he stopped taking antiretroviral drugs. The study also includes a possible third remission after stem cell transplantation, this person is referred to as the “Düsseldorf patient.”

May 2, 2019 – A study of nearly 1,000 gay male couples, where one partner with HIV took antiretroviral therapy (ART), found no new cases of transmission to the HIV-negative partner during sex without a condom. The landmark, eight-year study, published in the Lancet medical journal shows that the risk of passing on the HIV virus is eliminated with effective drugs treatment.

October 7, 2019 – Governor Gavin Newsom signs a bill making HIV prevention drugs available without a prescription in California starting on January 1, 2020. The medications covered by the new legislation are pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), which both help prevent HIV infections. California becomes the first state in the country to allow pharmacists to provide the drugs without a physician’s prescription.

November 6, 2019 – According to a study published in the Journal of Acquired Immune Deficiency Syndromes, a team of scientists has detected a new strain of HIV. The strain is a part of the Group M version of HIV-1, the same family of virus subtypes to blame for the global HIV pandemic, according to Abbott Laboratories, which conducted the research along with the University of Missouri, Kansas City.

June 15, 2020 – A study is published in the journal JAMA Network Open showing that the life expectancy of people with HIV approaches that of people without the virus, when antiviral therapy is started early in infection. However, disparities still remain in the number of chronic health problems that people with HIV endure.

July 7, 2020 – Scientists presenting at the 23rd International AIDS Conference announce a new study that found an injection of the investigational drug cabotegravir every eight weeks was more effective at preventing HIV than daily oral pills. It is also announced that a Brazilian man might be the first person to experience long-term HIV remission after being treated with only an antiviral drug regimen – not stem cell transplantation.

November 16, 2021 – A new study finds a second patient whose body has seemingly rid itself of HIV. The international team of scientists reports in the Annals of Internal Medicine that the patient, originally from the city of Esperanza, Argentina, showed no evidence of intact HIV in large numbers of her cells, suggesting that she may have naturally achieved what they describe as a “sterilizing cure” of HIV infection. The 30-year-old woman in the new study is only the second patient who has been described as achieving this sterilizing cure without help from stem cell transplantation or other treatment.

December 20, 2021 – The US Food and Drug Administration announces that it has approved the first injectable medication for pre-exposure prophylaxis (PrEP) to lower the risk of getting HIV through sex.

February 15, 2022 – A US woman becomes the third known person to go into HIV remission, and the first mixed-race woman, thanks to a transplant of stem cells from umbilical cord blood, according to research presented at a conference on Retroviruses and Opportunistic Infections.

December 1, 2022 – An experimental HIV vaccine, called eOD-GT8 60mer, has been found to induce broadly neutralizing antibody precursors among a small group of volunteers in a Phase 1 study. The clinical trial results, published in the journal Science, suggest that a two-dose regimen of the vaccine, given eight weeks apart, can elicit immune responses against the human immunodeficiency virus.

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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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How a medication abortion, also known as an ‘abortion pill,’ works | CNN



CNN
— 

While legal battles over access to mifepristone, one of two drugs used for medication abortions, play out in court, the drug continues to be available in states which consider abortion legal.

“While many women obtain medication abortion from a clinic or their OB-GYN, others obtain the pills on their own to self-induce or self-manage their abortion,” said Dr. Daniel Grossman, a professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco.

“A growing body of research indicates that self-managed abortion is safe and effective,” he said.

Mifepristone blocks the hormone progesterone, which is needed for a pregnancy to continue. The drug is approved to end a pregnancy through 10 weeks’ gestation, which is “70 days or less since the first day of the last menstrual period,” according to the FDA.

In a medication abortion, a second drug, misoprostol, is taken within the next 24 to 48 hours. Misoprostol causes the uterus to contract, creating cramping and bleeding. Approved for use in other conditions, such as preventing stomach ulcers, the drug has been available at pharmacies for decades.

Together, the two drugs are commonly known as the “abortion pill,” which is now used in more than half of the abortions in the United States, according to the Guttmacher Institute, a research group that supports abortion rights.

“Some people do this because they cannot access a clinic — particularly in states with legal restrictions on abortion — or because they have a preference for self-care,” said Grossman, who is also the director of Advancing New Standards in Reproductive Health, a research group that evaluates the pros and cons of reproductive health policies and publishes studies on how abortion affects a woman’s health.

What happens during a medication abortion? To find out, CNN spoke with Grossman. The conversation has been edited for clarity.

CNN: What is the difference between a first-trimester medication abortion and a vacuum aspiration in terms of what a woman experiences?

Dr. Daniel Grossman: A vacuum aspiration is most commonly performed under a combination of local anesthetic and oral pain medications or local anesthetic together with intravenous sedation, or what is called conscious sedation.

An injection of local anesthetic is given to the area around the cervix, and the cervix is gently dilated or opened up. Once the cervix is opened, a small straw-like tube is inserted into the uterus, and a gentle vacuum is used to remove the pregnancy tissue. Contrary to what some say, if the procedure is done before nine weeks or so, there’s nothing in the tissue that would be recognizable as a part of an embryo.

The aspiration procedure takes just a couple of minutes; then the person is observed for one to two hours until any sedation has worn off. We also monitor each patient for very rare complications, such as heavy bleeding.

Grossman: A medication abortion is a more prolonged process. After taking the pills, bleeding and cramping can occur over a period of days. Bleeding is typically heaviest when the actual pregnancy is expelled, but that bleeding usually eases within a few hours. On average people continue to have some mild bleeding for about two weeks or so, which is a bit longer than after a vacuum aspiration.

Nausea, vomiting, fever, chills, diarrhea and headache can occur after using the abortion pill, and everyone who has a successful medication abortion usually reports some pain.

In fact, the pain of medication abortion can be quite intense. In the studies that have looked at it, the average maximum level of pain that people report is about a seven to eight out of 10, with 10 being the highest. However, people also say that the pain can be brief, peaking just as the pregnancy is being expelled.

The level of cramping and pain can depend on the length of the pregnancy as well as whether or not someone has given birth before. For example, a medical abortion at six weeks or less gestation typically has less pain and cramping than one performed at nine weeks. People who have given birth generally have less pain.

CNN: What can be done to help with the pain of a medication abortion?

Grossman: There are definitely things that can be used to help with the pain. Research has shown that ibuprofen is better than acetaminophen for treating the pain of medication abortion. We typically advise people to take 600 milligrams every six hours or so as needed.

Some people take tramadol, a narcotic analgesic, or Vicodin, which is a combination of acetaminophen and hydrocodone. Recent research I was involved in found medications like tramadol can be helpful if taken prophylactically before the pain starts.

Another successful regimen that we studied combined ibuprofen with a nausea medicine called metoclopramide that also helped with pain. Other than ibuprofen, these medications require a prescription.

Another study found that a TENS device, which stands for transcutaneous electrical nerve stimulator, helps with the pain of medication abortion. It works through pads put on the abdomen that stimulate the nerves through mild electrical shocks, thus interfering with the pain signals. That’s something people could get without a prescription.

Pain can be an overlooked issue with medication abortion because, quite honestly, as clinicians, we’re not there with patients when they are in their homes going through this. But as we’ve been doing more research on people’s experiences with medication abortion, it’s become quite clear that pain control is really important. I think we need to do a better job of treating the pain and making these options available to patients.

CNN: Are there health conditions that make the use of a medication abortion unwise?

Grossman: Undergoing a medication abortion can be dangerous if the pregnancy is ectopic, meaning the embryo is developing outside of the uterus. It’s rare, happening in about two out of every 100 pregnancies — and it appears to be even rarer among people seeking medication abortion.

People who have undergone previous pelvic, fallopian tube or abdominal surgery are at higher risk of an ectopic pregnancy, as are those with a history of pelvic inflammatory disease. Certain sexually transmitted infections can raise risk, as does smoking, a history of infertility and use of infertility treatments such as in vitro fertilization (IVF).

If a person is on anticoagulant or blood thinning drugs or has a bleeding disorder, a medication abortion is not advised. The long-term use of steroids is another contraindication for using the abortion pill.

Anyone using an intrauterine device, or IUD, must have it removed before taking mifepristone because it may be partially expelled during the process, which can be painful.

People with chronic adrenal failure or who have inherited a rare disorder called porphyria are not good candidates.

CNN: Are there any signs of trouble a woman should watch for after undergoing a medication abortion?

Grossman: It can be common to have a low-grade fever in the first few hours after taking misoprostol, the second drug in a medication abortion. If someone has a low-grade fever — 100.4 degrees to 101 degrees Fahrenheit — that lasts more than four hours, or has a high fever of over 101 degrees Fahrenheit after taking the medications, they do need to be evaluated by a health care provider.

Heavy bleeding, which would be soaking two or more thick full-size pads an hour for two consecutive hours, or a foul-smelling vaginal discharge should be evaluated as well.

One of the warning signs of an ectopic pregnancy is severe pelvic pain, particularly on one side of the abdomen. The pain can also radiate to the back. Another sign is getting dizzy or fainting, which could indicate internal bleeding. These are all very rare complications, but it’s wise to be on the lookout.

We usually recommend that someone having a medication abortion have someone with them during the first 24 hours after taking misoprostol or until the pregnancy has passed. Many people specifically choose to have a medication abortion because they can be surrounded by a partner, family or friends.

Most people know that the abortion is complete because they stop feeling pregnant, and symptoms such as nausea and breast tenderness disappear, usually within a week of passing the pregnancy. A home urine pregnancy test may remain positive even four to five weeks after a successful medication abortion, just because it takes that long for the pregnancy hormone to disappear from the bloodstream.

If someone still feels pregnant, isn’t sure if the pregnancy fully passed or has a positive pregnancy test five weeks after taking mifepristone, they need to be evaluated by a clinician.

People should know that they can ovulate as soon as two weeks after a medication abortion. Most birth control options can be started immediately after a medication abortion.

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Covid-19 Pandemic Timeline Fast Facts | CNN



CNN
— 

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

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

WHO Situation Reports

Coronavirus Map

CNN’s early reporting on the coronavirus

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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



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Getting prescription meds via telehealth might change soon. Here’s how to prepare | CNN

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CNN
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For three years now, the expansion of telehealth has made care more accessible for many people, especially those in rural areas. Patients have been able to receive prescriptions from providers without seeing them in person. But that may change come May 11 when the federal government is set to end the Covid-19 public health emergency declaration that made this convenience possible.

Before the pandemic, medical practitioners were subject to the conditions of the Ryan Haight Act, which required at least one in-person examination before prescribing a controlled medicine, said Dr. Shabana Khan, chair of the American Psychiatric Association’s Committee on Telepsychiatry.

“There are seven exceptions, and one of them is a public health emergency declared by the secretary of (health and human services), which is what we’ve had for the past three years,” Khan said. “It was immensely helpful … and allowed many Americans to get their medical care without having to come in person, so we could treat patients completely remotely.”

“The administration and HHS has put out a notice that they don’t intend to renew it any further,” Khan said, “so the federal public health emergency is going to be expiring May 11.”

Returning to pre-pandemic rules means people who were prescribed controlled medications via telehealth — such as stimulant medications for attention-deficit/hyperactivity disorder, benzodiazepines for anxiety, or medications for opioid use disorder, sleep or pain — will need one in-person medical examination to continue these prescriptions or start new ones.

The US Drug Enforcement Administration’s website has a general list of controlled substances, and an exhaustive list can be found here.

Patients will still be able to get prescriptions for non-controlled medications, such as antibiotics or birth control, via telehealth. The pre-pandemic rules also wouldn’t affect telehealth care by a practitioner who has already conducted an in-person examination of a patient.

To establish some flexibility in the telehealth framework moving forward, Khan said, the DEA has put forth proposals (PDF) that would allow telehealth practitioners to prescribe one 30-day supply of buprenorphine — a medication for opioid use disorder — or Schedule III-V non-narcotic controlled medications without doing an in-person examination first. A patient would have to do an in-person exam before the second prescription of either type of medication, according to those proposals.

But there’s no guarantee that will happen — public comment on the proposals was open through March; since then, the DEA has been considering comments before drafting final regulations.

“It is really important to start planning now,” Khan said. “For many medicines, it can be a risk to abruptly stop treatment.”

People who are on medications for opioid use disorder, ADHD or anxiety and don’t get an in-person exam between May 11 and the next time they need a prescription refill could experience withdrawal requiring a trip to the hospital, or negative effects on health, relationships, employment or academics, she added.

Here’s what else you should know about the changes and steps you should take, according to Khan.

This conversation has been lightly edited and condensed for clarity.

CNN: How should people prepare to ensure their prescription routine isn’t disrupted?

Khan: It’s important for patients who may be prescribed one of these types of medicines by a telemedicine physician or other practitioner to reach out to that practitioner to discuss this issue and make sure that they have a plan. And if it’s feasible to see that telemedicine physician in person, schedule that as soon as possible.

CNN: What if you can’t see your telehealth provider in person?

Khan: Let’s say a telemedicine physician practices completely remotely — then the patient would discuss with them what next steps would be.

In the proposed rule, the qualifying telemedicine referral may allow a patient to be seen by a local DEA-registered practitioner. So, for example, perhaps their primary care doctor or pediatrician — if they are DEA-registered — might be able to go through the qualifying telemedicine referral process so that they can see them in person and continue to be prescribed the medicine. Or patients can contact their health insurance provider to get a list of local referrals.

CNN: Are there any drawbacks to seeing general physicians or pediatricians for controlled medication prescriptions?

Khan: Some may say they aren’t going to prescribe certain medications, like psychiatric medications. Some may say they are comfortable with it, and some may say they will prescribe for a short period of time until you connect with a specialist. So there is variability.

CNN: Would the patient have to continue seeing the referral provider after that first in-person appointment?

Khan: In terms of what’s required at the federal level, if a patient has that one in-person exam with a provider through that qualifying telemedicine referral process, they wouldn’t necessarily have to see that provider again unless that’s part of their treatment plan that’s discussed.

With the qualifying telemedicine referral in the proposed rule, the way it’s written, it doesn’t necessarily have to be the referral practitioner prescribing the medicine; they just need to do the in-person exam. The referral practitioner can refer the patient back to the telemedicine doctor, who can prescribe the medicine.

The other factor that’s significant here is we discussed all the proposed rules and the status at the federal level, but there’s also the state level. States also have rules around controlled medicine prescribing, and they may not always align with federal law. Let’s say the DEA puts out their final rule, and there’s some flexibility — some states might adopt the older Ryan Haight Act language from the federal level, so they might actually be stricter than what we’ll be seeing at the federal level. When federal and state laws don’t align, providers generally have to follow whatever is stricter.

CNN: Will patients need to see their provider in person every time they need a prescription refill?

Khan: The DEA has indicated that the absolute requirement at the federal level is one in-person examination. Beyond that, it would be left to the discretion of whoever the patient is seeing.

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Amid contradictory laws, hospitals in one state were unable to explain policies on emergency abortion care, study finds | CNN



CNN
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Oklahoma’s laws restricting abortions have created a confusing, contradictory environment that may have a chilling effect on health care, new research says.

After the US Supreme Court overturned the right to an abortion last year with the Dobbs v. Jackson Women’s Health Organization decision, several states quickly passed laws that restricted such procedures. A report released Tuesday and described in the medical journal the Lancet finds that the laws in at least one state left workers at many hospitals confused about how to proceed.

When the court made its decision, the Oklahoma law that criminalized abortion in 1910 went back into effect, according to the state’s attorney general. Lawmakers then created multiple overlapping laws that further criminalized abortion and increased penalties for those who performed or assisted in an abortion procedure, according to the new report from Physicians for Human Rights, Oklahoma Call for Reproductive Justice and the Center for Reproductive Rights.

The Oklahoma laws allow abortion in the case of a medical emergency, but one doesn’t define a medical emergency. Another says it allows for the “preservation of life in a medical emergency,” defined as causing “substantial and irreversible body of bodily impairment” – which is not a medical term, experts say.

To understand exactly how well Oklahoma hospitals understood the laws, the researchers used a “secret shopper method,” study co-author Dr. Michele Heisler said.

Researchers posed as prospective patients and called 34 hospitals to ask about the emergency pregnancy care they offered.

Heisler said that when the researchers designed the study, she expected the hospitals to tell the patients that they could get help in an emergency but that a second provider might have to sign off on an abortion or that a doctor would have to get the decision past an “onerous” hospital oversight committee.

“What we weren’t expecting is that there would be so much confusion and contradictory information and really not clear information,” said Heisler, who is medical director at Physicians for Human Rights and a professor of internal medicine and public health at the University of Michigan.

The researchers said that none of the hospitals they contacted in Oklahoma was totally able to articulate clear, consistent policies for emergency obstetric care to potential patients.

Specifically, 65% – 22 of the 34 hospitals – were unable to provide information about policies, procedures or the support provided to doctors when it is clinically necessary to terminate a pregnancy to save the life of a pregnant patient.

In 14 of the 22 cases, hospital representatives provided unclear and/or incomplete answers about whether doctors require approval to perform a medically necessary abortion.

Three of the hospitals said they do not provide abortions at all, even though it remains legal in the case of a medical emergency or to “preserve the life” of the pregnant person. Four others provided information that was factually wrong, the report says.

Four hospitals said they had formal approval processes that clinicians must go through if they have a situation in which it is medically necessary to terminate a pregnancy; they cannot make that decision on their own.

Three hospitals indicated that they have policies for these situations but refused to share any information about them.

“Unfortunately, it is being just left up to individual health systems and clinicians to try to make sense of these laws and provide guidance and support,” Heisler said.

The Oklahoma Hospital Association said it has been in conversations with Oklahoma’s medical licensure boards to seek clarity about the state’s conflicting abortion laws.

The association sent guidance to its members in September to explain what it interpreted as “saving the life of a pregnant woman” and what the laws would mean for a person made pregnant through rape or incest, among other issues. The guidance explains that the state’s criminal laws do not make an exception for these circumstances unless it is to save the life of someone who is pregnant in a medical emergency.

The guidance also warns that a person convicted of “administering, prescribing, advising, or procuring a woman to take any medicine drug or substance, or a person convicted of using or employing any instruction or ‘other means whatever,’ with the intent to procure an abortion, shall be guilty of a felony punishable by two (2) to (5) years imprisonment. From August 27, 2022, forward, a person convicted of performing or attempting to perform an abortion shall be guilty of a felony punishable by a fine not to exceed One Hundred Thousand ($100,000.00) and/or imprisonment not to exceed ten (10) years.”

The guidance says the “persons potentially liable” are the provider, not the pregnant person.

Study co-author Rabia Muqaddam, a senior staff attorney at the Center for Reproductive Rights who is working on multiple cases challenging the abortion bans in Oklahoma, called the overlapping laws a “bizarre” situation.

“Aside from the fact that there are so many of them is that they all conflict,” she said. “All of the laws have inconsistent definitions, which is where a lot of the confusion comes from for health care providers. What’s most dangerous for patients is the fact that the definitions of medical emergency and life-preserving abortions is unclear and inconsistent.”

“If I was the hospital general counsel and I was looking at these laws, I have absolutely no idea what my physician could or could not do in any particular circumstance,” she said.

When there is a lack of clarity and when penalties are involved, “what you get is massive chill.”

“Physicians are terrified. They’re terrified that if they make the wrong decision, they’re going to go to jail. They’re going to lose their license. And at the other end of that is that patients are being seriously harmed,” Muqaddam said.

Sonia M. Suter, a professor of law at George Washington University who was not involved in the new research, said recent abortion laws have created “such a mess.”

“You are telling physicians that they have two conflicting obligations,” said Suter, whose scholarship focuses on issues at the intersection of law, medicine and bioethics, with a particular focus on reproductive rights.

There is an obligation to stabilize patients in emergencies that may not always qualify as “life-threatening,” but doctors and hospitals could also risk being sued because the doctors are not following the standard of care, “which you can’t do with how some of these exceptions are worded.”

She said hospitals also don’t know how the laws will be applied. Lawyers typically will instruct institutions to interpret the law as conservatively as possible, and physicians may be equally conservative because they don’t want to risk their licenses or face stiff penalties.

“It’s just devastating for everybody,” Suter said. “It’s just cruel.”

Molly Meegan, general counsel for the American College of Obstetricians and Gynecologists, said state laws to restrict abortion with emergency exceptions are not comprehensive.

“They can’t be applied in a medical situation. They just aren’t practical,” she said. “They have an ethical and personal duty to their patients to do what is best for their patients. It can at times be in direct conflict with whatever the laws are, especially if they’re vague, and most of the ob/gyns throughout the country, including in Oklahoma, are in an impossible situation.”

Meegan and Suter both believe the confusion will lead to the deaths of more women. Those who survive may be left with dire health problems, including losing the ability to have children in the future.

“They already have horrific maternal mortality and infant mortality rates,” Suter said. “It feels like the end of evidence-based medicine.”

According to the US Centers for Disease Control and Prevention, Oklahoma persistently ranks among the states with the worst rates of maternal deaths, even before the new abortion laws went into effect. The state had a maternal mortality rate of 25.2 deaths per 100,000 live births for 2018-20, well above the national average.

For communities of color, the rate is significantly worse, according to the Oklahoma Health Department.

White women had 23.2 maternal deaths per 100,000 live births for 2018-20, the lowest rate overall in Oklahoma. The rates for Black women and Native American women were about twice as high: 49.4 and 44.4, respectively.

Oklahoma is not alone. The 13 states where most abortions are banned generally have some of the highest infant and maternal mortality rates in the country, Heisler said. Even more states could be restricting abortion access soon, the experts believe, with potentially more problems to come.

“The hostile climate many states are creating for the health care field by enacting criminal and other penalties for abortion care is an outcome whose reverberations we are only just beginning to see,” said Kelly Baden, vice president for public policy at the reproductive health nonprofit Guttmacher Institute.

Heisler noted that the researchers don’t blame the hospitals or the doctors for this confusion. Overall, she said, the staffers who talked to the researchers “were wonderful,” despite the circumstances.

“They were empathetic. They said, ‘I completely understand.’ They tried to give answers. They acted in good faith. But really, none of the hospitals were really able to say what we were hoping for, which is to unequivocally state that they would stand behind their clinicians and that clinicians at their facilities would be able to use their best clinical judgment for the individual case and that it would be made as medical decisions should be in collaboration with the patient, taking into account to their needs, their preferences and their values,” she said.

“We are recognizing that hospitals and clinicians are in an untenable situation,” Heisler added.

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



CNN
— 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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



CNN
— 

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

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

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

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

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

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

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

Over the years, that authority became more defined.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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