Prasad Resigns From Top FDA Post Amid Fallout Over Sarepta Dispute
As director of the Center for Biologics Evaluation and Research, Dr. Vinay Prasad oversaw the regulation of vaccines and gene therapy drugs such as Sarepta Therapeutics' treatment for Duchenne muscular dystrophy. During his brief tenure, Prasad limited the use of covid shots and amped up warnings about a rare cardiac side effect of the shots, The New York Times wrote.
The New York Times:
Top F.D.A. Official Vinay Prasad Resigns Under Pressure
The Food and Drug Administration’s top vaccine and gene therapy official resigned on Tuesday after a public campaign against him led by the right-wing influencer Laura Loomer, according to people familiar with the matter. Over the past week, Ms. Loomer had taken to social media to attack the official, Dr. Vinay Prasad, for a series of decisions denying approval of new drugs for rare diseases. She highlighted past statements of support he had made for prominent figures on the political left, including Senator Bernie Sanders, independent of Vermont. Andrew Nixon, a Department of Health and Human Services spokesman, confirmed the resignation Tuesday evening. (Jewett, 7/29)
The Washington Post:
FDA Pushes To Restrict Synthetic Opioid Derived From Kratom Lea
Health officials announced they will seek to add 7-OH — a potent substance synthesized from a compound in the kratom leaf — to the tier of controlled substances reserved for the most addictive drugs, such as heroin and LSD. FDA Commissioner Marty Makary said at a news conference that the agency is not asking to restrict natural products made from kratom, which contains trace amount of the compound. In a report released Tuesday, the agency said it maintains concerns about kratom broadly but needed to act urgently on 7-OH because of its risk of sedation, nausea, breathing problems and addiction. “We think it’s night and day in terms of the public health risk,” Makary said of 7-OH products. (Ovalle and Cunningham, 7/29)
On the federal crackdown of gender-affirming care —
The Hill:
FTC Eyes Probe Into Deceptive Practices Related To Gender-Affirming Care
The Federal Trade Commission (FTC) on Monday launched a public inquiry into whether providers of gender-affirming health care are violating federal consumer protection laws. In a news release, the FTC said it opened the inquiry “to better understand how consumers may have been exposed to false or unsupported claims about ‘gender-affirming care’, especially as it relates to minors, and to gauge the harms consumers may be experiencing.” (Migdon, 7/29)
KFF Health News:
Tribal Groups Assert Sovereignty As Feds Crack Down On Gender-Affirming Care
At the Two Spirit Conference in northern Nevada in June, Native Americans gathered in support of the LGBTQ+ community amid federal and state rollbacks of transgender protections and gender-affirming health care. “I want people to not kill themselves for who they are,” said organizer Myk Mendez, a trans and two-spirit citizen of the Fort Hall Shoshone-Bannock Tribes in Idaho. “I want people to love their lives and grow old to tell their stories.” “Two-spirit” is used by Native Americans to describe a distinct gender outside of male or female. (Orozco Rodriguez, 7/30)
On climate and health —
CNN:
EPA Proposes Revoking Pollution Limits Based In Part On Document Authored By 5 Climate Contrarians
In one of its most significant reversals on climate policy to-date, the Trump administration on Tuesday proposed to repeal a 2009 scientific finding that human-caused climate change endangers human health and safety, EPA Administrator Lee Zeldin announced. If successful, the repeal could strip away the federal government’s most powerful way to control the country’s planet-warming pollution and fight climate change. The repeal was based in part on a hastily produced report — authored by five researchers who have spent years sowing doubt in the scientific consensus around climate change — that questions the severity of the impacts of climate change. (Nilsen and Freedman, 7/29)
Scientific American:
Hurricane Forecasters Keep Crucial Satellite Data Online After Threatened Cuts
Satellite data that are useful for weather forecasting—and particularly crucial to monitoring hurricanes—will not be cut off by the Department of Defense at the end of the month as originally planned. The data, which provide an x-ray-like view of a hurricane’s internal structure, will remain accessible to the National Oceanic and Atmospheric Administration for the satellites’ lifespans, a NOAA spokesperson confirmed in an e-mail to Scientific American. These data are particularly useful for monitoring storms at night, when visible satellite imagery is unavailable, and for catching rapid intensification—when a storm’s winds jump by at least 35 miles per hour in 24 hours. The faster forecasters note a storm is quickly ramping up in intensity, the faster they can warn people in harm’s way. (Thompson, 7/29)
On the immigration crisis —
KFF Health News:
Immigrant Kids Detained In ‘Unsafe And Unsanitary’ Sites As Trump Team Seeks To End Protections
A child developed a rash after he was prevented from changing his underwear for four days. A little boy, bored and overcome with despair, began hitting himself in the head. A child with autism and attention-deficit/hyperactivity disorder was forced to go without his medication, despite his mother’s pleas. “I heard one officer say about us ‘they smell like sh–,’” one detained person recounted in a federal court filing. “And another officer responded, ‘They are sh–.’” (West, 7/30)
