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Morning Rounds Elizabeth Cooney

Mishaps and miscommunications overshadow AstraZeneca’s Covid vaccine

Anthony Fauci told STAT yesterday AstraZeneca’s press release of overly positive data “was an unforced error by the company.” That was just the latest in the drug manufacturer’s long string of mishaps and miscommunications. It follows widely publicized snafus like administering incorrect doses during clinical trials and keeping U.S. regulators in the dark after pausing a trial entirely due to safety concerns. Then there were unlucky issues, too, like an investigation into blood clots in vaccine recipients, that were beyond AstraZeneca’s control. The repeated gaffes have frustrated many public health leaders, who, given the available data, view the AstraZeneca shots as an effective and potentially transformative tool that could greatly help expand vaccine access around the world.

A swashbuckling CEO flies AstraZeneca into turbulence

Pascal Soriot (PABLO MARTINEZ MONSIVAIS/AP)

It took eight years, a failed hostile takeover, and a sweeping scientific turnaround for AstraZeneca CEO Pascal Soriot to become one of the drug industry’s leading lights. Now, after 11 bumbling months of Covid-19 vaccine development, the French-born executive finds himself at the center of a multinational credibility crisis. The failure is of a piece with his successes. Soriot has been a storied swashbuckler of a CEO, with a fighting spirit he credits to a pugilistic upbringing in a hard-up suburb of Paris. He turned around AstraZeneca by making big bets on risky medicines. But that same tendency to rush in where angels fear to tread seems to have backfired. STAT’s Matthew Herper and Daman Garde have more for STAT+ subscribers.

African Americans who smoke appear to be at higher risk for coronary heart disease

African Americans are more likely to die of coronary heart disease than white Americans, but the precise reasons why aren’t as well-understood because of their underrepresentation in clinical trials. A new study finds that African American smokers — about 15% of that population — have more than twice the risk of developing coronary heart disease compared to those who do not smoke. The authors believe their observational study is the first to untangle the connection between smoking, the inflammation it leads to, and this common cause of heart disease, which develops when calcified blood vessels starve the heart of oxygen and nutrients. For 14 years, the researchers tracked nearly 4,500 participants in the Jackson Heart Study, established in 2000 to “reverse the epidemic” of cardiovascular disease in African Americans. 

Inside STAT: Motherhood in medicine, pandemic parenting, and being needed by patients of color

(Mike Reddy for STAT)

Returning to the workforce after parental leave is difficult in the best of circumstances. The pandemic made it even harder for STAT columnist Jennifer Adaeze Okwerekwu to pick up her caseload of 160-some patients. As a Black psychiatrist, she feels deeply the shortage of mental health providers in this country — only 2% of practicing psychiatrists are Black. So between patients, she fielded prior authorizations and demands for return calls, all while trying to understand a Medicare billing overhaul — and while hearing her baby cry downstairs from her makeshift home office. “This is motherhood in medicine. This is pandemic parenting. I tried to take it all in stride,’” she writes. “Then on the next day, I lost my sense of taste and smell, and I eventually tested positive for Covid-19.” Read more.

Rugby study diagnoses concussions with spit test

Concussions can be challenging to diagnose. When they happen on the playing field, a clinician on the sidelines makes a judgment call that even CT or MRI can’t help with. A new study of professional rugby players, perhaps predictably called SCRUM, reports that saliva tests may offer quick answers to whether someone has a brain injury. The researchers tested just over 1,000 players who had head injuries during play — immediately and then hours and days later — and compared them to players who had musculoskeletal injuries. Looking for small non-coding RNAs that genetic sequencing had implicated in lab tests, they found 14 of these biomarkers in players later confirmed to have concussion after their brain injuries had been ruled out. Studies in women and non-professional athletes are underway.

More unapproved stimulants found in sports and weight loss supplements

Pieter Cohen, a physician known for ferreting out FDA-prohibited substances in dietary supplements, was looking for one such stimulant in weight loss and sports remedies. He and his colleagues found it — deterenol, linked to adverse events including cardiac arrest — plus eight other banned stimulants. After 17 supplements bought online were analyzed in two labs, deterenol and other prohibited stimulants were found in various combinations in the supplements. Up to four other stimulants were found in the supplements that FDA has not approved. The combination of unapproved or prohibited substances in varying amounts is concerning, the researchers write in a new study: "Clinicians should remain alert to the possibility that patients may be inadvertently exposed to experimental and prohibited stimulants when consuming weight loss and sports supplements."

Covid-19 cases in the U.S.

Cases yesterday: 52,878
Deaths yesterday
: 894

What to read around the web today

  • Amy Abernethy, deputy commissioner who aimed to amp up FDA’s tech knowhow, to leave post. STAT+
  • E.U. set to curb Covid vaccine exports for 6 weeks. New York Times
  • AstraZeneca Covid-19 vaccine dispute shines spotlight on data monitoring boards. Wall Street Journal
  • Stop blaming Tuskegee, critics say. It's not an 'excuse' for current medical racism. NPR
  • The curious case of Florida’s pandemic response. The Atlantic

Thanks for reading! More tomorrow,

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