It's almost like he was never gone

Vinay Prasad is returning to lead the FDA's biologics center two weeks after leaving the agency amid tensions related to a gene therapy product, Lizzy Lawrence reported over the weekend.

If you're having a difficult time keeping up, don't feel bad.

Here's a brief recap: FDA asked Sarepta to stop shipping the gene therapy following three patient deaths. The company said no, then yes. A backlash followed, including a campaign against Prasad by far-right social media influencer Laura Loomer. The FDA reversed itself, and Prasad departed.

Now he's back. Read more.

And don't miss Matt Herper's advice for Prasad as he settles back in at the FDA. Trust me, this is worth a read.

cder

'A challenging time'

Before tackling the Prasad news over the weekend, Lizzy wrote an exclusive on the agency's top drug regulator meeting with staff.

Lizzy obtained recordings of a Friday staff meeting with Center for Drug Evaluation and Research Director George Tidmarsh, and of another meeting the previous week with CDER's Office of New Drugs. In those meetings, FDA employees pushed for answers on whether the agency would restore funding for research fellows, when they will be allowed to easily attend conferences again, and why FDA's leaders are holding ad-hoc panels instead of advisory committee meetings with experts whose conflicts of interest are clearly delineated.

"I know that I'm coming in here at a challenging time," Tidmarsh told staff on Friday. "That is not lost on me."

Read more about Tidmarsh's assurances that he and other leaders are bringing operations back to normal.

cdc

Lockdown at CDC

Daniel Payne and Helen Branswell provide an account of what happened during the shooting at CDC and in its aftermath.

Their story is based in large part on a call between CDC leadership and staff of the National Center for Immunization and Respiratory Diseases. In addition to recounting their experiences, employees asked whether "misinformation" influenced the shooter, as well as about health secretary Robert F. Kennedy Jr.'s response to the crisis.

According to the AP, the shooter was mad about the Covid-19 vaccine, blaming it for making him depressed and suicidal. CDC's acting COO Christa Capozzola confirmed in an email to staff that the agency was targeted for its role in responding to Covid-19.

CDC leaders offered first steps for their responses, including expanded mental health support and security reviews. Read more.

medicare advantage

Research laundering

In the eighth installment of STAT's Health Care's Colossus investigation, Casey Ross, Bob Herman, Tara Bannow, and Lizzy dive into the research machine that helps UnitedHealth maintain its profits.

UnitedHealth is the biggest Medicare Advantage insurer and controls the largest collection of doctors in the U.S., giving it a position on both sides of many health care transactions. That allows the company to collect a vast amount of proprietary data, which it deploys to support research showing its business practices are better for older Americans than traditional Medicare coverage, they report.

The team of STAT reporters asked 13 of the country's leading health policy experts to assess the methodology and conclusions behind that research. Those independent experts said research supported by UnitedHealth and by special interest groups that favor Medicare Advantage is flawed and inconclusive about the benefits of the health insurance program.

Read more to learn about the tactics UnitedHealth has used to make its research appear unbiased and to get that research in front of lawmakers and policymakers.

vaccines

Oh, the irony

When the federal government canceled $500 million in contracts to help develop messenger RNA vaccines, RFK Jr. had a simple explanation for the cancellation: the vaccines don't work and aren't safe.

On Sunday, during an appearance on Steve Bannon's podcast "War Room," NIH Director Jay Bhattacharya gave an alternative explanation, Helen reports. Bhattacharya said the mRNA technology platform is not viable because the public doesn't trust it.

Left unmentioned is that distrust of mRNA vaccines is due in part to assertions by high-profile vaccine skeptics like Kennedy that they don't work. FDA-approved mRNA vaccines do work, they're safe, and many people trust them — Covid-19 vaccines saved millions of lives. Read more.

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