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Morning Rounds Shraddha Chakradhar

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Biogen, FDA at odds over timing of crucial confirmatory trial of Alzheimer’s drug

One of the lingering questions in the wake of Monday's landmark approval of Biogen's Aduhelm is how the company will now tackle the FDA's requirement of a confirmatory trial. Initially, company officials stated that it could take up to nine years to complete a trial showing whether the Alzheimer's drug truly benefited patients. But in a new STAT+ story, STAT's Adam Feuerstein and Matthew Herper write that this schedule didn't seem to sit well inside the agency. “I don’t have a timeline, but we certainly hope to see the study completed in the next several years,” an FDA official told STAT. 

In more fallout from the Aduhelm decision, STAT's Andrew Joseph reports that one member of an FDA advisory committee that last fall recommended against Aduhelm's approval has resigned.

Democrats in Congress introduce bill to protect and codify abortion rights

Lawmakers in Washington yesterday reintroduced a 2019 Senate bill known as the Women's Health Protection Act, which, if passed, would protect abortion care in the U.S. The effort, brought by Democrats in both the House and the Senate, comes just days after SCOTUS agreed to hear a challenge to the 1973 Roe v. Wade decision. If signed into law — which seems like a distant possibility given the highly partisan nature of Congress — the WHPA would allow health providers to provide abortions without stipulations and would also protect the procedure from being banned in states or otherwise subject to restrictions. According to the Guttmacher Institute, 16 states have thus far enacted more than 80 restrictions — and 10 bans — on abortions in 2021 alone. 

Inside STAT: Two-thirds of Congress cashed a pharma campaign check in 2020

The final installments of STAT's Prescription Politics series — which has tracked the drug industry's political giving — finds that a significant number of state and federal lawmakers alike cashed checks from pharma during the 2020 election cycle. Two-thirds of Oregon's state lawmakers accepted at least one campaign check from the drug industry, for instance, which may explain why repeated efforts in that state to cap the price of insulin and other reforms aimed at high drug costs have failed. An examination at the federal level reveals more than two-thirds of Congress accepted a payment from pharma. Together, the analyses from STAT's Lev Facher — featuring interactives from STAT contributor Kaitlyn Bartley — offer an unprecedented look at drug industry influence on lawmakers.

Urban-rural divide in mortality rates has deepened in the past 20 years

Though mortality rates are falling overall in urban and rural areas, two decades of CDC data reveal a widening gulf in those declines between the two areas. The study looked at data from 1999-2019. In 2019, the mortality rate in urban parts of the U.S. was nearly 665 deaths per 100,000 people, but that rate in rural areas was 834 deaths per 100,000 people. Over 20 years, the gap between the two types of areas grew by 172%. And although men had higher mortality rates than women, men and women in rural areas fared worse than their urban counterparts. While Black people had the highest mortality rates across areas, white individuals saw the smallest gains in slowing mortality rates. 

Almost a quarter of older adults report routinely having multiple drinks in one sitting

Nearly 1 in 4 older U.S. adults report routinely having three or more drinks during one sitting, according to a new poll from the University of Michigan's National Poll on Healthy Aging. Here's more:

  • The study: More than 2,000 adults ages 50-80 were asked about their drinking habits pre-pandemic and during its first 10 months. 
  • The findings: 23% of those surveyed said they regularly had three or more alcoholic drinks in one sitting. One in 10 also said they use other substances including marijuana that can interact with alcohol in risky ways. 
  • The pandemic: Around 14% said their drinking increased during the pandemic. But between a third and half of adults who reported drinking to cope with boredom, pain, or stress or boost their mood said they drank more during pandemic months than before. Around 1 in 10 overall said they thought their pandemic drinking became excessive, but few sought help. 

New report estimates a nearly 7% increase in medical costs in 2022

A new report from PwC's Health Research Institute estimates that the cost of treating patients in 2022, a measure known as medical cost trend, will go up 6.5% compared to this year. This figure is slightly less than the 7% that the same group predicted as the medical cost trend for 2021, a dip that the report states is likely due to fewer persistent effects of people having put off care during the pandemic. At the same time, the report estimates that, compared to 2020, care that people seek next year — for routine surgeries or treatment for advanced stages of cancers that were missed — could lead to higher medical expenses. The report also estimates that other downstream effects of the pandemic, such as worsening substance use rates or long Covid, could also drive up health costs next year. 

Covid-19 in the U.S.

Cases yesterday: 13,011
Deaths yesterday: 380

What to read around the web today

  • A broken system: Why Covid-19's impact on Indigenous communities is impossible to know. Searchlight New Mexico
  • Spreading vaccine fears. And cashing in. The Center for Public Integrity
  • Unused Johnson & Johnson Covid doses are piling up as FDA waits to see if shelf life can be extended. Kaiser Health News
  • Biogen isn’t worried about backlash to ‘bewildering’ price of Alzheimer’s drug. STAT+
  • ‘This IS INSANE’: Africa desperately short of COVID vaccine. Associated Press
  • 178 hospital workers suspended for not complying with coronavirus vaccination policy. The Washington Post

Thanks for reading! More tomorrow,

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