Overnight Health Care: Eli Lilly to apply for accelerated approval of unproven Alzheimer’s drug | Study finds big drop in US life expectancy, especially for Blacks, Hispanics | Largest providers in Mass. to require COVID vaccine
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Today: Three Massachusetts hospital systems will require employees to be vaccinated against COVID-19. Eli Lilly is going to take advantage of new FDA precedent and file for expedited approval of its Alzheimer’s drug and the pandemic caused a major drop in U.S. life expectancy.
We’ll start with Alzheimer’s drugs:
Eli Lilly to apply for accelerated approval of unproven Alzheimer’s drug
The pharma giant is looking to take full advantage of the potential new precedent set by the Food and Drug Administration (FDA) following its approval of Biogen’s Aduhelm.
Eli Lilly on Thursday said it plans to submit its Alzheimer’s drug to FDA for accelerated approval later this year, a move that takes advantage of the agency’s controversial approval of a similar drug from Biogen.
The company in a statement said it intends to submit its drug called donanemab to the FDA by the end of the year, but it could happen much sooner.
Lilly said the agency gave donanemab a “breakthrough therapy” designation, which is meant to expedite the development and review of drugs that may demonstrate substantial improvement over already established therapies.
Context: The announcement from Lilly comes after the FDA overruled its own outside advisory panel earlier this year to approve Biogen’s drug Aduhelm, saying it was “reasonably likely” the treatment would slow cognitive decline in patients. Aduhelm was granted accelerated approval based on a “surrogate endpoint.”
Instead of basing the decision on whether the drug slows cognitive decline, FDA granted approval based on the reduction of amyloid plaque in the brain. FDA officials have since defended the decision and said there is evidence that shows plaque reduction helps patients, but many experts are not so sure.
Lilly’s drug: Donanemab is also an amyloid-reducer, and the company said it will file for approval based on the results of a mid-stage clinical trial involving 272 patients. The company is conducting a larger phase 3 trial, but Thursday’s announcement indicates the company is not going to wait for the results.
Study finds big drop in US life expectancy, especially for Blacks, Hispanics
Life expectancy in the United States declined by the largest amount since World War II between 2018 and 2020 amid the COVID-19 pandemic, a new study finds.
The study published in the British Medical Journal finds that U.S. life expectancy declined by 1.87 years between 2018 and last year, from 78.74 years to 76.87 years.
That decline comes as COVID-19 caused more deaths in the U.S. than have been reported in any other country, with the total now more than 600,000.
The drop in life expectancy was disproportionately high among Black and Hispanic Americans, declining by 3.88 years among Hispanic people and 3.25 years among Black people, compared to only 1.36 years among white people.
The U.S. also does not stack up well when compared to a peer group of other high-income countries in the study. The U.S. life expectancy decline was 8.5 times the drop in peer countries —0.22 years — increasing the gap between the U.S. and peer countries to 4.69 years.
“The US had a much larger decrease in life expectancy between 2018 and 2020 than other high income nations, with pronounced losses among the Hispanic and non-Hispanic Black populations,” the authors write.
Three of the largest hospital systems in Massachusetts requiring employees get vaccinated
Three of Massachusetts’s largest hospital systems have announced they are requiring their employees to get vaccinated against COVID-19.
Mass General Brigham said in a statement that it is requiring its 80,000 employees to get vaccinated once the Food and Drug Administration (FDA) grants full approval to one of the three vaccines currently in use.
Thus far, more than 85 percent of Mass General’s employees have been vaccinated, the hospital said. The hospital system has administered more than 450,000 vaccine doses to patients and employees.
Likewise, Beth Israel Lahey Health (BILH) announced on Wednesday that it plans to require all physicians and staff to get vaccinated against COVID-19 “as a condition of employment” after at least one of the vaccines gets final approval.
BILH President and CEO Kevin Tabb said in a video message that some employees didn’t feel comfortable getting vaccinated because the vaccines only had emergency authorization.
However, Tabb said he “fully expects” for the vaccines to be fully approved “later this year.” At that point, inoculations will be mandatory.
Missouri becomes newest COVID-19 hot spot as variant spreads
Missouri has become the latest COVID-19 hot spot in the U.S., recording the country’s highest rate in new infections, a surge health officials have largely attributed to the highly transmissible delta variant and vaccine hesitancy.
In Missouri, which reported more than 800 new cases on Wednesday, just about 44 percent of residents have received one dose of the coronavirus vaccine, with 38 percent fully vaccinated, according to the Centers for Disease Control and Prevention.
However, USA Today noted Wednesday that most southern and northern counties in the state have not even reached close to 40 percent of citizens with at least one shot.
In one Missouri county, just 13 percent have received at least one dose.
Mercy and Cox South hospitals in the southwestern Missouri city of Springfield had a combined 153 patients hospitalized on Tuesday, an increase from just 31 a few months ago, according to USA Today.
What we’re reading
The Supreme Court saved Obamacare. Now supporters want Biden to fix the law. (Politico)
Nearly all COVID deaths in US are now among unvaccinated (Associated Press)
Why more people are getting two different coronavirus vaccines (The New York Times)
A crucial, overlooked question on the new Alzheimer’s drug: When should patients stop taking it? (Stat)
State by state
Georgia sued for ban on gender-affirming care under Medicaid (Associated Press)
At Texas border, pandemic’s high toll lays bare gaps in health and insurance (Kaiser Health News, El Paso Matters)
New CDC dataset showing COVID vaccine-by-county numbers misses the entire state of Texas. Why? (Houston Chronicle)
Op-eds
Let’s make patients the customer, not the product, in health care
5 things the US should be doing — in addition to COVID-19 vaccination
As schools reopen, we must not forget about students’ mental health
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