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Morning Rounds Shraddha Chakradhar

Trump has launched an all-out attack on the FDA. Will its scientific integrity survive?

Presidents sparring with the FDA is not new, but recent moves from President Trump mark a new frontier for attacks from the White House on the regulatory agency. For instance, the administration recently installed a gun-rights advocate and right-wing journalist as the FDA's chief spokesperson, allowing for partisan communication from an agency that has historically put out apolitical messaging. Last weekend, Trump baselessly claimed that the FDA was part of a "deep state" conspiracy to harm his reelection campaign. Taken together with FDA Commissioner Stephen Hahn's misstatements in announcing the agency's emergency approval of convalescent plasma therapy, experts are concerned about the FDA's scientific credibility, especially when it has to seriously consider — and convince the public about — Covid-19 vaccines and treatments. Read more from STAT's Lev Facher in Washington here

Coronavirus testing official defends CDC's new testing guidelines

Brett Giroir, the HHS official in charge of Covid-19 testing, defended a controversial change to CDC guidelines this week that says asymptomatic people probably don't need testing, even if they've been exposed to an infected individual. “What we've tried to do is put more responsibility onto public health officials,” Giroir said during a call with reporters. The change has been widely criticized, as experts are concerned it will make it difficult to find and isolate infected individuals.” NIAID head Anthony Fauci told CNN that he was under anesthesia for vocal cord surgery when the task force met to discuss the new guidance, and that he was worried it "will give people the incorrect assumption asymptomatic spread is not of great concern. In fact it is,” he said. Typically, CDC guidelines are annotated with references to scientific papers, public health expert Wafaa El-Sadr told STAT. “That’s the norm, that’s what’s expected,” she said. “I think it really behooves the CDC to put forward the evidence.”

Major U.S. and U.K. cancer initiative to tackle big unanswered questions in research 

The National Cancer Institute in the U.S. and Cancer Research UK just joined forces to launch Cancer Grand Challenges, an international initiative to address the biggest unanswered questions in cancer research. The initiative expands on a program from Cancer Research UK, which is a research and advocacy group in the U.K., since 2015 that has funded research into unnecessary breast cancer treatment and using the microbiome to treat bowel cancers. The new Cancer Grand Challenges program will announce its chosen themes in October, and hopes by 2022 to award $25 million over five years to four research teams. The new initiative also hopes to offer three such rounds of funding, with new themes announced every other year. 

Inside STAT: Scientists create a synthetic lining for the intestine to make delivering drugs easier


The synthetic lining, which has been applied to the pig intestinal tissue on the right, is designed to stick to the intestines. (COURTESY JUNWEI LI)

Scientists who set out to find an alternative for kids' medicines than hard-to-swallow tablets have reported creating a synthetic intestinal lining, one that could one day be swallowed in a single solution. In a new study, researchers describe how they tested the lining system made of dopamine and hydrogen peroxide in pig models such that the lining could coat and stick to the small intestine stably for one day. They found the system could deliver digestive enzymes to regulate glucose absorption and the breakdown of lactose. It was also able to deliver drugs for a condition caused by a parasitic flatworm, work that could one day be studied for human use. Read more from STAT's Pratibha Gopalakrishna here

A new policy guide to help community leaders combat mental health issues

The nonprofit advocacy group de Beaumont Foundation and the Well Being Trust just released a policy guide for leaders looking to help their communities address mental health problems. As more people report struggling with mental health in the wake of the pandemic, the comprehensive guide offers both short- and long-term recommendations. Among the short-term recommendations is working to de-stigmatize mental health and to normalize the fact that people have been adversely affected by the pandemic. The policy guide also includes strategies for particularly vulnerable groups, including frontline workers, older adults, and people of color. For older adults, for instance, recommendations include having volunteers provide training for technology to enable older people to stay in touch with friends and family to avoid isolation. 

Clinical trials are getting smaller, testing more non-drug therapies

An analysis of nearly 20 years of data from ClinicalTrials.gov shows that these studies have been skewing smaller in size, and that fewer drug trials have been conducted over time. Here's more from the study, which looked at data from more than 245,000 trials conducted between 2000-2019: 

  • Sponsorship: Only 3% of the trials were sponsored by the NIH or other government entity, while 29% were industry-sponsored. Government-sponsored trials decreased over time, while trials funded by industry or other sources increased with time. 
  • Sample sizes: The average sample size for trials was 60 participants, a figure that decreased over the study duration. More than half of industry-led trials, and 67% of NIH-led trials, had fewer than 100 enrollees.  
  • Interventions: The proportion of completed trials testing drugs went from 71% in 2000 to just 40% in 2019. In contrast, trials testing non-drug interventions such as devices or behavioral therapies doubled through the study's duration. 

What to read around the web today

  • How Mike Pence slowed down the coronavirus response. Politico
  • A woman may have been cured of HIV without medical treatment. The New York Times
  • Black diabetics lose limbs at triple the rate of others. Here’s how health care leaders are starting to act. ProPublica
  • Why the United States is having a coronavirus data crisis. Nature
  • Why seasonal depression can happen in the summer too. National Geographic

Thanks for reading! More tomorrow,

Shraddha

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Thursday, August 27, 2020

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