January 2023

The Food and Drug Administration on Tuesday finalized a rule change that allows women seeking abortion pills to get them through the mail, replacing a long-standing requirement that they pick up the medicine in person. 

The Biden administration implemented the change last year, announcing it would no longer enforce the dispensing rule. Tuesday’s action formally updates the drug’s labeling to allow women to get a prescription via telehealth consultation with a health professional, and then receive the pills through the mail, where permitted by law. 

Still, the rule change’s impact has been blunted by numerous state laws limiting abortion broadly and the pills specifically. Legal experts foresee years of court battles over access to the pills, as abortion-rights proponents bring test cases to challenge state restrictions. 

For more than 20 years, the FDA labeling had limited dispensing to doctor’s offices and clinics, due to safety concerns. During the COVID-19 pandemic, the FDA temporarily suspended the in-person requirement. The agency later said a new scientific review by agency staff supported easing access, concurring with numerous medical societies that had long said the restriction wasn’t necessary. 

Two drugmakers that make brand-name and generic versions of abortion pills requested the latest FDA label update. Agency rules require a company to file an application before modifying dispensing restrictions on drugs. 

Danco Laboratories, which sells branded Mifeprex (mifepristone), said in a statement the change “is critically important to expanding access to medication abortion services and will provide healthcare providers” another option for prescribing the drug. 

More than half of U.S. abortions are now done with pills rather than surgery, according to the Guttmacher Institute, a research group that supports abortion rights. 

The FDA in 2000 approved mifepristone to terminate pregnancies of up to 10 weeks when used with a second drug, misoprostol. Mifepristone is taken first to dilate the cervix and block the progesterone hormone, which is needed to sustain a pregnancy. Misoprostol is taken 24 to 48 hours later, causing the uterus to contract and expel pregnancy tissue. 

Bleeding is a common side effect, though serious complications are very rare. The FDA says more than 3.7 million U.S. women have used mifepristone since its approval. 

Several FDA-mandated safety requirements remain in effect, including training requirements to certify that prescribers can provide emergency care in the case of excessive bleeding. Pharmacies that dispense the pills also need a certification. 
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Walter Cunningham, the last surviving astronaut from the first successful crewed space mission in NASA’s Apollo program, died Tuesday in Houston. He was 90.

NASA confirmed Cunningham’s death in a statement but did not include its cause. Spokespersons for the agency and Cunningham’s wife, Dot Cunningham, did not immediately respond to questions.

Cunningham was one of three astronauts aboard the 1968 Apollo 7 mission, an 11-day spaceflight that beamed live television broadcasts as they orbited Earth, paving the way for the moon landing less than a year later.

Cunningham, then a civilian, crewed the mission with Navy Capt. Walter M. Schirra and Donn F. Eisele, an Air Force major. Cunningham was the lunar module pilot on the space flight, which launched from Cape Kennedy Air Force Station, Florida, on October 11 and splashed down in the Atlantic Ocean south of Bermuda.

NASA said Cunningham, Eisele and Schirra flew a near perfect mission. Their spacecraft performed so well that the agency sent the next crew, Apollo 8, to orbit the moon as a prelude to the Apollo 11 moon landing in July 1969.

The Apollo 7 astronauts also won a special Emmy award for their daily television reports from orbit, during which they clowned around, held up humorous signs and educated earthlings about space flight.

It was NASA’s first crewed space mission since the deaths of the three Apollo 1 astronauts in a launch pad fire January 27, 1967.

Cunningham recalled Apollo 7 during a 2017 event at the Kennedy Space Center, saying it “enabled us to overcome all the obstacles we had after the Apollo 1 fire and it became the longest, most successful test flight of any flying machine ever.”

Cunningham was born in Creston, Iowa, and attended high school in California before enlisting with the Navy in 1951 and serving as a Marine Corps pilot in Korea, according to NASA. He later obtained bachelor’s and master’s degrees in physics from the University of California at Los Angeles, where he also did doctoral studies, and worked as scientist for the Rand Corporation before joining NASA.

In an interview the year before his death, Cunningham recalled growing up poor and dreaming of flying airplanes, not spacecraft.

“We never even knew that there were astronauts when I was growing up,” Cunningham told The Spokesman-Review.

After retiring from NASA in 1971, Cunningham worked in engineering, business and investing, and became a public speaker and radio host. He wrote a memoir about his career and time as an astronaut, “The All-American Boys.” He also expressed skepticism in his later years about human activity contributing to climate change, bucking the scientific consensus in writing and public talks, while acknowledging that he was not a climate scientist.

Although Cunningham never crewed another space mission after Apollo 7, he remained a proponent of space exploration. He told the Spokane, Washington, paper last year, “I think that humans need to continue expanding and pushing out the levels at which they’re surviving in space.”

Cunningham is survived by his wife, his sister Cathy Cunningham, and his children Brian and Kimberly.
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A top health official in China has said that the fatalities from the latest surge in COVID-19 cases are “increasing” but within the normal range for mortality.

In an interview with state broadcaster China Central Television (CCTV), Jiao Yahui, a National Health Commission official, said, “We have a huge base, so what people feel is that the severe cases, the critical cases or the fatalities are increasing.

“Relative to the rest of the world, the infection peaks we are faced with across the country are not unusual,” she added. 

The contrast between statements by Chinese officials assessing the COVID situation and social media footage of crowded hospital hallways and long lines at clinics prompted leading scientists advising the World Health Organization to call Tuesday for a “more realistic picture” about what China is experiencing after the pivot from “zero-COVID.”

Normal mortality is the number of deaths authorities expect for a specific period based on long-term population data. Excess mortality reveals the difference between the number of deaths caused during the current wave of COVID and the number of fatalities expected had the pandemic not occurred. The excess mortality number has been used worldwide during the pandemic to provide a better sense of how many people have died of COVID.

Tong Zhaohui, vice president of Chaoyang Hospital in Beijing, agreed that while the actual number of deaths is growing, the fatalities remain a small percentage of China’s population.

“Think how many people around you have been infected but how many have developed critical cases or pneumonia? I think everyone has the idea,” he told CCTV.

China began relaxing its stringent zero-COVID policy in early December. Since then, Tong has supervised treatment for critically ill COVID patients at two major hospitals in Beijing.

Tong said, “I roughly counted, both severe and critical cases (of COVID) at the two designated hospitals accounted for 3% to 4% of infected patients.” He added that the actual number can’t be determined because PCR testing is no longer mandatory.

Beijing reported three new COVID deaths for Monday, taking the official death toll to 5,253 since the pandemic began in January 2020. China’s population was over 1.4 billion people in 2021.

CCTV’s coverage acknowledged that the number of fever outpatients in some hospitals increased tenfold, and one doctor saw up to 150 patients in one night. A fever patient cannot be assumed to be a COVID patient.

Photos and videos of hospitals full of sick people waiting to be treated are circulating on social media from facilities across the country. Reuters visited a Shanghai hospital and reported finding crowded hallways and emergency rooms. China’s censors are moving quickly to keep photos and videos from circulating inside the country, but many are leaping the country’s Great Firewall for the internet and posting photos and videos that were said to be from hospitals in China’s central and southern Hunan province as well as other cities.

Although VOA Mandarin was unable to independently verify the videos circulating on Twitter that are said to show hospitals in Hunan, a staffer who answered the phone at Changsha No. 1 People’s Hospital in Changsha, the province’s capital, said the hospital has no vacant beds left and new patients are being asked to go to other hospitals. According to Baike, China’s version of Wikipedia, the hospital has a total capacity of 1,593 beds. The staffer said that while many doctors have tested positive, they are still working.

Social media videos from various cities show long lines waiting to be admitted outside crematoriums.

In an interview with Da Jiangdong Studio, an affiliate of the state-run newspaper People’s Daily, Chen Erzhen, vice president of Shanghai’s Ruijin Hospital and a member of the city’s COVID expert advisory panel, estimated that 70% of population of 25 million people in Shanghai may have been infected. The interview was conducted December 31 and published Tuesday.

“Now the spread of the epidemic in Shanghai is very wide, and it may have reached 70% of the population, which is 20 to 30 times more than (in April and May),” he told Da Jiangdong Studio. Shanghai endured a two-month long lockdown in April and May, during which over 600,000 residents were infected and already weakened global supply chains were further strained.

China could see as many as 25,000 deaths a day from COVID later in January, according to a Bloomberg report.

That daily total is “roughly equivalent to China’s normal daily death toll from all other causes,” according to The British Medical Journal referencing research published December 20 from Airfinity, a London-based research firm that focuses on predictive health analytics.

Mortalities from the contagious respiratory illness will probably peak around January 23, the second day of the annual new year holiday, according Airfinity.

China said it had submitted genome sequence data from recently sampled COVID-19 cases to GISAID, an international database hosted by Germany, ahead of a meeting with WHO officials on Tuesday.

Before the meeting, Reuters reported that two unnamed scientists affiliated with WHO had asked Beijing for a “more realistic picture” of COVID in China.

Some experts doubted that Beijing would be forthright in its statistical offerings.

Alfred Wu, associate professor at the Lee Kuan Yew School of Public Policy at National University of Singapore, told Reuters, “I don’t think China will be very sincere in disclosing information.”

“They would rather just keep it to themselves, or they would say nothing happened, nothing is new,” said Wu. “My own sense is that we could assume that there is nothing new … but the problem is China’s transparency issue is always there.”
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Advocates for education and health care in Malawi are criticizing the government’s decision to close schools in two cities to try to contain a cholera outbreak. 

The Presidential Taskforce on Coronavirus and Cholera said in a statement Monday that the suspension is applied to all primary and secondary schools in the capital, Lilongwe, and commercial hub, Blantyre.

Khumbize Kandodo Chiponda, co-chairperson of the taskforce and Malawi’s minister of health, told a press conference Tuesday the decision is a result of the continuing increase in the number of cholera cases in the two cities.

As of Monday, the bacterial disease, spread by dirty water, had killed more than 620 people out of 18,222 cases since the outbreak began in March. 

Chiponda expressed fear for the safety of students and others if the schools remain open, adding that in just seven days, Blantyre recorded 792 cases with 36 deaths, and Lilongwe recorded 536 cases with 36 deaths.

But Malawian education and health rights campaigners say the timing of the suspension was wrong.

Hastings Moloko, trustee of the Private Schools Association of Malawi, told a press conference Monday that there is no logic in suspending learning in only two out of the 28 affected districts. 

“The playing field is not leveled,” he said. “It is schools in Blantyre and Lilongwe that have been affected. While other students are not learning, students everywhere else in the country are learning. And yet these students will sit for exactly the same exams, exactly at the same time. So, Blantyre and Lilongwe students will be disadvantaged in terms of time to cover their syllabuses.”

Moloko said there is also no scientific evidence that cholera spreads more in schools than in homes.

Cholera is an acute diarrheal infection caused by ingesting food or water contaminated with bacteria. The disease affects both children and adults, and if untreated, can kill within hours.

Agnes Nyalonje, minister of education in Malawi, said the move is to protect the lives of the learners in these two cholera hotspot districts. 

“The issue is a balance between protection of life and continuity of learning,” she said. “We have information that shows that currently across all schools, we are short of 1,262 boreholes or water supply in schools that need water supply. And we are saying personal hygiene and school hygiene have to go hand in hand.”

Nyalonje said her ministry has put measures in place that allow students in the closed schools to take lessons through distance learning, as was the case when the schools shut down for the COVID-19 pandemic. 

 
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