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The Readout Damian Garde & Meghana Keshavan

Good morning! Just noting that there'll be no edition of the newsletter on Monday, but we'll be back in your inbox first thing Tuesday morning.

Why is the president making drug ads?

Are antibodies the new vaccines? And is it ethical for doctors to talk about President Trump’s health?

We discuss all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we do our best to unpack Trump’s video-based endorsement of Regeneron Pharmaceuticals and his apparent acceptance that there won’t be a Covid-19 vaccine before Election Day. Then, Vir Biotechnology CEO George Scangos calls in to explain the process of developing a treatment much like the one Trump received and how the president’s sudden boosterism affects the day-to-day work of making medicines. Finally, we dig into an age-old debate in medicine: Is it ethical for doctors to comment on the health of famous patients?

Listen here.

The commissioner's job

Robert Califf, a former commissioner of the Food and Drug Administration, recently co-authored a Washington Post op-ed stating flatly that the Trump administration is applying undue pressure on the FDA. His co-authors included every living former FDA commissioner.

At a STAT virtual event Thursday, he joked that they thought about going further back, but deemed it impractical. “Political interference is a really bad thing, but it’s also naive to think there’s not political influence,” Califf said. “Public health and social-political issues can’t be completely separated. And a big job of the commissioner is to be the buffer between politicians who have every right by law to oversee the FDA and push it to be that buffer particularly for individual medical product decisions so the process can work without undue influence.”

Califf, now the head of clinical policy and strategy for Verily and Google Health, also talked about how clinical trials could be made better and, he said, an order of magnitude less expensive. The key? Technology will help, but the most important thing is asking important questions, and collecting only as much information as is needed to fully answer them.

It pays to read the risk factors

The FDA is investigating whether Intercept Pharmaceuticals’ only approved drug can lead to liver injury, something the company revealed in a paragraph on the 53rd page of an otherwise humdrum document filed with the SEC in August.

As STAT’s Adam Feuerstein reports, no one in biotech seemed to notice the disclosure until an investor highlighted it on Twitter this week. The FDA’s inquiry began in May, Intercept said, and it’s focused on Ocaliva, approved to treat the liver disease primary biliary cholangitis.

The bigger question is whether the FDA’s concern had anything to do with its June decision to reject Intercept’s application to get Ocaliva approved for NASH, a far more common liver disease. An Intercept spokesman said the safety issue “was not raised in the context of the review of our NASH” application and that the company has “no reason to believe” it led to the rejection. But investors, who sent Intercept’s share price down about 8% yesterday, seem to be alarmed.

Read more.

A long wait ends in disappointment for Amgen

Amgen and its partner Cytokinetics have spent the past 14 years developing a new heart treatment, and the last four running a huge clinical trial to prove its worth. Yesterday we got the results, and it turns out that time could have been better spent.

The trial met its primary endpoint of reducing the risk of hospitalization from heart failure, but it was no better than placebo at preventing death. And the drug’s effect on hospitalization amounted to an 8% benefit over placebo, which analysts perceived as marginal at best. By contrast, a similar study of AstraZeneca’s diabetes treatment Farxiga charted a 25% reduction in the risk of death or worsening heart failure.

Amgen didn’t say whether it planned to file for FDA approval, which “amounts to an admission of failure,” SVB Leerink analyst Geoffrey Porges wrote in an investor note. The company plans to present detailed data at a later medical conference, and might come up with a subgroup of participants who saw a significant benefit. If not, the biotech giant will likely have to write off more than a decade of work.

Read more.

More reads

  • What President Trump’s ‘compassionate use’ of a Covid-19 drug means — and doesn’t mean. (STAT)
  • Eli Lilly in deal to supply COVID-19 drugs to low-income countries. (Reuters)
  • Moderna vows not to enforce Covid-19 patents, but advocates say IP should be given to WHO. (STAT Plus)

Thanks for reading! Until next week,

Friday, October 9, 2020


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