Axios

Infant formula linked to a growing botulism outbreak may still be on shelves in several states, the FDA said this week.

The big picture: There were at least 31 infants with suspected or confirmed infant botulism linked to ByHeart brand formula as of Wednesday, the FDA said, but even after announcing a recall, the formula was still being sold across the country.

NEW YORK — Key players in biotech research at the Axios BFD summit on Nov. 18 discussed new drug development ideas and how the industry can adapt and grow amid major technological shifts.

• Axios' Katherine Davis and Claire Rychlewski moderated the roundtable discussion, which was sponsored by Bayer.

Why it matters: AI's role across the drug discovery process continues to grow, and companies are looking for ways to apply the technology to improve patient outcomes.

• However, no drug discovered exclusively by AI has reached the marketplace to date.

Five key takeaways from participants in the roundtable …

1. Products like GLP-1s are bellwethers for progress, Enveda CXO Daniel Wee said. "A lot of analysts would have written off [obesity treatment as] slower than it is, but having something like the GLP-1s show what the potential of a great drug can do."
2. Direct-to-consumer platforms can potentially educate patients about drug indications, said Alexander Kerman, head of life science at Ubie Health. As more pharmaceuticals hit the market with various uses in mind, it's important that the public understands how to access and use them safely.
3. The promise of AI in biotech advances isn't in small improvements, RA Venture partner Jacob Oppenheim said. It's in discovering entirely new ways to fight diseases.
4. If the tech industry, like AI, becomes too centralized by certain owners, "and we're beholden to those owners … we're going to lose, as a society," warned Procept, Partners LLC founder Shawn Knopp.
5. Clinical trials are king when it comes to predicting and evaluating results, Wee said: "It's going to be incredibly hard to refute what happens when you give someone a drug versus what a model says. We'll take the person every time."

Sponsored content:

Simon Rosof, Bayer Pharmaceutical's senior vice president and head of product and pipeline, noted how AI has streamlined the company's ability to screen gene-driven diseases.

• "We've seen the ability to already screen more than 5,000 gene-driven diseases, and get that down to five actionable pipeline targets in a matter of a single 90-day sprint."
• In the past, the process took close to a year, Rosof said.

Brian Cantwell, Bayer Pharmaceutical's vice president of digital strategy and product operations, addressed the challenge of patients researching and finding health care options via tools like ChatGPT, which lack physician oversight.

• "How do we create that single entry point … so that they can very quickly understand the options available to them, consult with a health care professional, and then ultimately make the best possible decision with the right treatment at the right price that they can afford?" he asked.

Eli Lilly reached a market valuation of $1 trillion in trading Friday, becoming the 10th member of an elite U.S. club dominated by the tech behemoths.

Why it matters: Crossing the threshold underscores Lilly's emergence as the new king of the obesity drug market.

The Centers for Disease Control and Prevention has updated its website to promote the widely debunked claim that vaccines may cause autism.

Why it matters: Health Secretary Robert F. Kennedy Jr. has repeatedly linked vaccines to autism, and now the public health agency he oversees is publicly reversing its position to reflect that belief.

• Multiple studies over decades have disproven links between childhood vaccines and developing autism.

State of play: The agency's webpage on vaccines and autism, updated Wednesday, now says the statement that vaccines don't cause autism "is not an evidence-based claim because studies have not ruled out the possibility that infant vaccines cause autism."

• "Studies supporting a link have been ignored by health authorities," the website continues.
• HHS in September released plans to contract with Rensselaer Polytechnic Institute to research connections between vaccines and autism.
• Career scientists at the agency were not consulted about the changes and were caught off guard by them, the Washington Post reported.

The CDC site previously said studies showed there was no connection between receiving vaccines and developing autism.

What they're saying: HHS communications director Andrew Nixon said the agency updated the site to reflect "gold standard, evidence-based science."

• He did not respond to questions about the timing of the change or who was involved.

Zoom in: The CDC website still has a heading that reads "Vaccines do not cause autism" followed by an asterisk. A note further down says the header hasn't been removed "due to agreement with the chair of the U.S. Senate Health, Education, Labor, and Pensions Committee that it would remain on the CDC website."

• During his confirmation process, Kennedy struck an agreement with committee chair Sen. Bill Cassidy (R-La.) that he would not dismantle vaccine safety systems or remove government vaccine guidance.

Cassidy posted on X Thursday: "I'm a doctor who has seen people die from vaccine-preventable diseases. What parents need to hear right now is vaccines for measles, polio, hepatitis B and other childhood diseases are safe and effective and will not cause autism."

• "Any statement to the contrary is wrong, irresponsible, and actively makes Americans sicker."

Peter Sullivan contributed.

This story has been updated with Cassidy's X post.

Lawmakers are losing hope for a deal to extend the Affordable Care Act's enhanced subsidies, with leaders in both parties admitting the odds of a bipartisan deal are slim to none.

Why it matters: The Senate will vote next month on extending the subsidies, which cover 22 million people and expire at the end of the year. Republicans are uniting against an extension, with President Trump pushing against it.

The Trump administration's dialed-back guidance on COVID-19 vaccines hasn't significantly changed Americans' willingness to get the shots heading into respiratory virus season, a Pew Research Center survey found.

The big picture: Most of the public either hasn't heard about the Centers for Disease Control and Prevention's new recommendations emphasizing personal choice or says it won't affect their decisions.

Top House Democrats on Thursday are due to unveil a plan to expand Medicare drug price negotiations in a bid to lower health costs.

Why it matters: The measure has no chance of being passed in this Congress, but it serves as a marker of where Democrats could go if they flip control of the House in the midterms.

The Trump administration is proposing to weigh immigrants' use of programs like Medicaid or SNAP, as well as other public benefits, when determining if they should get permanent residency.

Why it matters: The proposal is another case of the administration putting public health on a collision course with immigration policy.

All major chatbots are "fundamentally" unsafe for teen mental health support, children's advocacy group Common Sense Media said Thursday in a report showing systemic issues across the board.

Why it matters: People of all ages are turning to chatbots for therapy and mental health help, even as experts disagree on whether that's safe.