Month: November 2022

Two of the largest U.S. pharmacy chains — CVS and Walgreens — are reported to have tentatively agreed to pay more than $10 billion to settle more than 3,000 state and local lawsuits involving the dispensing of opioid painkillers.
In a statement released Wednesday, CVS Health said it agreed it will pay approximately $5 billion — with $4.9 billion to states and political subdivisions and approximately $130 million to Native American tribes — over the next 10 years beginning in 2023.
In a similar statement, Walgreens said it would make $4.95 billion in remediation payments to be paid out over 15 years. The company said the settlement frameworks include no admission of wrongdoing or liability.
In the statement, CVS Health Chief Policy Officer and General Counsel Thomas Moriarty said, “We are committed to working with states, municipalities and tribes, and will continue our own important initiatives to help reduce the illegitimate use of prescription opioids.”
Both companies’ statements included a list of initiatives undertaken to fight opioid abuse.
An earlier report said Walmart had also reached a tentative settlement, but a lawyer involved in the negotiations said those discussions are continuing.
In the lawsuits, governments said pharmacies were filling prescriptions they should have flagged as inappropriate.
If the settlements are finalized, they would mark the first nationwide deals with retail pharmacy companies. They follow nationwide opioid settlements with drugmakers and distributors totaling more than $33 billion.
Opioids are natural, synthetic, or semi-synthetic chemicals used to reduce the intensity of pain signals and feelings of pain. The class of drugs includes the illegal drug heroin, synthetic opioids such as fentanyl, and pain medications available legally by prescription, such as oxycodone, hydrocodone, codeine, morphine, and many others.
The U.S. Centers for Disease Control and Prevention reports that from 1999 to 2020, more than 564,000 people in the United States died from overdoses involving an opioid, including prescription and illicit ones. They report 187 people in the U.S. continue to die from an opioid overdose every day.

Source: Voice of America

Lebanon received a first batch of vaccines Monday to combat a worsening cholera outbreak – together with sharply worded criticism of its crumbling public health infrastructure from France, which facilitated the donation of the doses.

By Sunday, cases of cholera – a disease typically spread through contaminated water, food or sewage – stood at 1,447, with 17 deaths, since the first were recorded in the country a month ago, Lebanon’s health ministry said.

Lebanon had been cholera-free since 1993, but its public services are suffering under a brutal economic crisis now in its fourth year, while infighting among the country’s faction-riven elite has paralyzed its political institutions.

The outbreak has reached Beirut, but authorities say most cases remain concentrated where it started in the northern town of Bebnine, where health authorities have set up an emergency field hospital.

The vaccines would play “an essential role” in limiting the disease’s spread, Health Minister Firass Abiad told reporters in the capital as he announced the first batch.

Standing next to Abiad, French ambassador Anne Grillo said the delivery comprised more than 13,000 doses. They had been donated by the philanthropic arm of French health care company Sanofi and the French government had facilitated their arrival to Lebanon.

“The origins of this epidemic, in which public health is at stake, must also be treated,” Grillo told reporters. The outbreak was “a new and worrying illustration of the critical decline in public provision of access to water and sanitary services in Lebanon.”

In the Bebnine field hospital, two young boys sat next to each other on one hospital bed, while a mother waited anxiously to confirm if her son, lying limp on another bed and being treated by a doctor and a nurse, had also caught the disease.

Nearby, Syrian children in a makeshift refugee camp played in dirty water chocked with rubbish and medical waste and fed by an outflow from an open pipe.
The World Health Organization has linked cholera’s comeback in Lebanon to an outbreak in neighboring Syria, to where it had spread from Afghanistan via Iran and Iraq.

Source: Voice of America

New research shows vaccinating pregnant women helped protect their newborns from the common but scary respiratory virus called RSV that fills hospitals with wheezing babies each fall.
The preliminary results buoy hope that after decades of failure and frustration, vaccines against RSV may finally be getting close.
Pfizer announced Tuesday that a large international study found that vaccinating moms-to-be was nearly 82% effective at preventing severe cases of RSV in their babies’ most vulnerable first 90 days of life. At age 6 months, the vaccine still was proving 69% effective against serious illness — and there were no signs of safety problems in mothers or babies.
“Moms are always giving their antibodies to their baby,” said virologist Kena Swanson, Pfizer’s vice president of viral vaccines. “The vaccine just puts them in that much better position” to form and pass on RSV-fighting antibodies.
The vaccine quest isn’t just to protect infants. RSV is dangerous for older adults, too, and both Pfizer and rival GSK recently announced that their competing shots also proved protective for seniors.
None of the findings will help this year when an early RSV surge already is crowding children’s hospitals. But they raise the prospect that one or more vaccines might become available before next fall’s RSV season.
“My fingers are crossed,” said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University. “We’re making inroads.”
Tuesday’s data was reported in a press release and hasn’t been vetted by independent experts.
Here’s a look at the long quest for RSV vaccines.
What is RSV?
For most healthy people, RSV, or respiratory syncytial virus, is a cold-like nuisance. But for the very young, the elderly and people with certain health problems, it can be serious, even life-threatening. The virus can infect deep in the lungs, causing pneumonia, and in babies, it can impede breathing by inflaming tiny airways.
In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year, and several hundred die. Among adults 65 and older, about 177,000 are hospitalized with RSV and 14,000 die annually.
Worldwide, RSV kills about 100,000 children a year, mostly in poor countries.
Why is there no vaccine?
A tragedy in the 1960s set back the whole field. Using the approach that led to the first polio vaccine, scientists made an experimental RSV vaccine by growing the virus in a lab and killing it. But testing in children found not only was the vaccine not protective, youngsters who caught RSV after vaccination fared worse. Two died.
“For a period of 20 years, even though science was advancing, nobody wanted to go near development of an RSV vaccine,” Schaffner said.
Even today’s modern RSV vaccine candidates were tested first in older adults, not children, he noted.
How did development get back on track?
Modern vaccines tend to target the outer surface of a virus — what the immune system sees when a germ invades. For RSV, that target is the so-called F protein that helps the virus latch onto human cells. Again, there was a hurdle: That protein is a shape-shifter, rearranging its form before and after it “fuses” to cells.
It turns out that the immune system only forms effective RSV-fighting antibodies when it spots what’s called the pre-fusion version of that protein, explained structural biologist Jason McLellan of the University of Texas at Austin.
In 2013, McLellan and virologist Barney Graham were working at the National Institutes of Health when they homed in on the correct shape and figured out how to freeze it in that form. That finding opened the way to today’s development of a variety of experimental RSV vaccine candidates.
(That same discovery was key to the hugely successful COVID-19 vaccines, as the coronavirus also is cloaked in a shape-shifting surface protein.)
What’s in the pipeline?
Several companies are creating RSV vaccines, but Pfizer and GSK are furthest along. Both companies recently reported final-stage testing in older adults. The competing vaccines are made somewhat differently but each proved strongly effective, especially against serious disease. Both companies plan to seek regulatory approval in the U.S. by the end of the year, as well as in other countries.
The older-adult data “looks fantastic,” said McLellan, who has closely followed the vaccine development. “I think we’re on the right track.”
And if vaccinating pregnant women pans out, it could be “a win for two individuals instead of just one,” by offering protection to both mom-to-be and baby, said Dr. Wilbur Chen of the University of Maryland School of Medicine.

Pfizer’s maternal vaccine is the same recipe that it tested successfully in older adults — and it also plans to seek Food and Drug Administration approval for those vaccinations by year’s end.
The new study included 7,400 pregnant women in 18 countries, including the U.S., and spanned multiple RSV seasons. Preliminary results reported Tuesday show the vaccine was most effective against severe disease. For milder illness, effectiveness was 51% to 57% — short of the study’s statistical requirements but a result that Pfizer still called clinically meaningful because it could mean fewer trips to the doctor’s office.

Source: Voice of America