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Morning Rounds Shraddha Chakradhar

What’s next after the FDA’s historic approval of Biogen’s Alzheimer’s drug



In a landmark decision, the FDA yesterday approved Biogen's Alzheimer's drug aducanumab, the first new therapy for the disease in nearly two decades. The drug, also known as Aduhelm, is given intravenously once a month and will carry a sticker price of $56,000 yearly (although the actual price will vary depending on a patient's insurance). STAT's Liz Cooney has the answers to other FAQs, and here's more on what the approval means:

  • An extra twist: Doctors were not expecting the curveball that Aduhelm would be approved for all Alzheimer's patients, especially since drug trials were done in those with early-stage disease. Because the drug helped clear the amyloid plaques associated with the condition, the FDA argued it could work across the spectrum disease. STAT's Andrew Joseph has more here.
  • The cost implications: With the $56,000 price, Aduhelm is already one of the most expensive drugs marketed to primary care physicians. In a new story for STAT+ subscribers, STAT's Ed Silverman writes that public and private payers alike may now look for ways to limit the way Aduhelm is covered, which may make the drug inaccessible to a large swath of people seeking it. 
  • The FDA is shifting its rules: With Aduhelm, the FDA relied on a process known as "accelerated approval," which is frequently used for cancer drugs. In a new story for STAT+ subscribers, STAT's Matthew Herper writes "this allowed the agency to approve the drug even in the absence of clear outward signs that it slowed patients’ decline."

Aduhelm trial participants reflect on their complicated reactions to approval

With the approval of Biogen's Aduhelm, participants in the trials testing the drug are experiencing a mix of emotions. There's pride that their contributions led to an important advancement against the debilitating disease. Yet, there is also the poignant recognition that Aduhelm represents only a slowing down of disease progression and isn't a cure in and of itself. Patients are also aware that the FDA's decision is wrought with criticism, and that the path forward for Biogen to confirm a clinical benefit may mean the therapy becomes unavailable someday. “We moved the needle, but this is not a dance-around-the-Christmas-tree moment,” one participant tells STAT's Andrew Joseph, who has more here.

Apple announces new features to share health data with doctors, track trends over time

At the annual Worldwide Developers Conference yesterday, tech giant Apple rolled out a new health record tool, one that will make it easier for users to share health information with selected people. Users can now choose which family members or providers can access protected health information — information that Apple said is not shared even with the company. This tool also allows users to find out more behind a particular lab test, such as the one to measure high cholesterol levels, without having to toggle over to Google to learn more. Other features the company unveiled: hearing assistance, a feature to assess mobility, and a respiratory tracker. 

Inside STAT: New model improves CPR coaching for people who speak limited English

Even though CPR administered by a bystander has been shown to help someone who is experiencing cardiac arrest, some estimates suggest that a small percentage of those experiencing distress actually receive such CPR — and it's even less for Black and Hispanic people. In 2014, the Los Angeles Fire Department rolled out a new program that allowed people at a dispatch center to ask fewer questions to help bystanders quickly identify when someone was having a heart attack and administer CPR. Now a new study finds that compared to the LAFD's old program, the new one improved not only the rate at which cardiac arrests were identified but increased the use of CPR among callers with limited English proficiency. STAT's Kevin Lin has more here

Kids of color, from poor households more likely to have exposure to gun violence


Around 1 in 5 U.S. adolescents were within a six-minute walking distance of gun violence in recent years, according to a new study. Researchers linked gun violence incidents in 2014-2017 to residences and schools of adolescents born between 1988-2000, and found 21% overall lived or attended school within 500 meters of a gun violence incident in the prior year. Vast disparities existed among different groups: Only 4% of white adolescents fit the six-minute walk or 500m criterion, whereas that rate was 36% for Black adolescents and 29% for those who were Hispanic. Across income levels, nearly three times as many poor adolescents were exposed to gun violence recently as those from high-income homes. Exposure to violence can harm physical and psychological health, the authors write, and encourage implementing policies to reduce armed violence. 

New study shows telehealth use is going down as pandemic in the U.S. wanes

As the pandemic in the U.S. wanes, a new report from FAIR Health finds telehealth utilization is also going down. Claim lines for telehealth fell by around 5% in March compared to February 2021, which had a nearly 16% drop from January 2021. While mental health was still the top telehealth service, diagnoses for other conditions — such as hypertension and soft tissue diseases — saw a drop. At the same time, telehealth claims related to developmental disorder diagnoses remained about the same. One possible explanation: Hypertension and soft tissue disorders tend to affect adults, who have been able to get vaccinated and return to doctors' offices. Developmental disorders largely affect children, most of whom still can't get vaccinated. 

Covid-19 in the U.S.

Cases yesterday: 15,496
Deaths yesterday: 324

What to read around the web today

  • Where did the microchip vaccine conspiracy theory come from anyway? Reveal
  • Despite its high price tag, the new Alzheimer’s drug isn’t reigniting the drug pricing debate. STAT+
  • With roots in civil rights, community health centers push for equity in the pandemic. Kaiser Health News
  • India to provide free vaccines to all in major policy shift. Associated Press
  • Why Biogen may be sitting on the most lucrative product in pharmaceutical history. STAT+

Thanks for reading! More tomorrow,

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