In advocates’ push for superbug funding, ‘$6 billion is nothing’

Biotech
Friday, September 8th, 2023 5:00 am EDT

When Peggy Lillis died of a Clostridium difficile infection in 2010, her sons were shocked.

Lillis had gone to the dentist for a routine root canal and, four days later, wound up in the hospital from an infection caused by the treatment she was taking for an abscess. Ultimately, it took her life.

“She died from this thing that I, an incredibly neurotic person, had never heard of,” said her oldest son, Christian Lillis, who had spent years working with LGBTQ+ advocacy groups to reduce HIV infection rates. “At that point, they estimated it killed about 14,000 people a year,” he added, pointing out that figure exceeded the number of drunk driving-related deaths in the U.S. that year.

Knowing that more could be done to reduce C. diff fatality rates, Lillis and his brother Liam created the nonprofit Peggy Lillis Foundation to raise awareness and shape policy to improve treatments for the infection.

Thirteen years later, C. diff is estimated to cause between 15,000 and 30,000 deaths annually in the U.S. and is among the most urgent superbug threats, according to the Centers for Disease Control and Prevention. 

Despite increasing awareness, policy initiatives aimed at spurring drug development to treat C. diff and antibiotic-resistant infections have repeatedly stalled.

One such initiative — the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance, or PASTEUR, Act — has been introduced three times in Congress since 2019 to no avail. The bill’s price tag has been cut down from $11 billion over 10 years originally to $6 billion in the most recent iterations.

If passed, the legislation would create a subscription-based funding model that would allow the Department of Health and Human Services to pay drug developers for approved antibiotics based on their value to society. In exchange, federally insured patients would receive the drug for free.

Earlier this year, the Peggy Lillis Foundation joined more than 200 organizations in urging Congress to pass the PASTEUR Act in its mandatory reauthorization of the Pandemic and All Hazards Preparedness Act, the law that lays the foundation for the nation’s biosecurity policy and emergency public health response.

However, the Sept. 30 deadline for PAHPA’s reauthorization is fast approaching and PASTEUR is not currently included in either the House or the Senate’s version of the bill.

What’s next?

So far, advocates say they’re undeterred by the roadblocks the PASTEUR Act has faced in the last few years.

“We want to see PASTEUR passed regardless of what the legislative vehicle is,” said David Hyun, director of antibiotic resistance research at The Pew Charitable Trusts. “We will continue to advocate for this to be included in any other legislation that’s relevant,” including omnibus bills later this year.

Most lawmakers understand the importance of PASTEUR, Lillis said. The hurdle is getting them to prioritize the $6 billion in funding over other projects that might present their constituents with a more immediate visible impact.

“We have to help the public understand what a post-antibiotic future could look like, and then we have to make it clear that $6 billion is nothing,” Lillis said. “The federal government spends about $2 trillion on healthcare … in that, $6 billion is almost like a rounding error.”

PASTEUR came close to the finish line last fall, but several Democrats moved against the measure after some academics surfaced concerns that drugs paid for under the program wouldn’t improve patient outcomes.

“Without any strict requirement that the drugs should improve patient outcomes, this multi-billion-dollar gift would also lead to an influx of antimicrobials that we as physicians would have difficulty in determining whether they are beneficial or indeed harmful for our patients,” wrote Reshma Ramachandran, a professor at the Yale School of Medicine, and John Powers, a professor at the George Washington University School of Medicine, in an op-ed last year advocating against PASTEUR.

Hyun argued that the bill wouldn’t be a “blank check” for all drugmakers developing antibiotics. Rather, he said the law contains “mechanisms and guardrails to make sure that the funding goes to drugs that meet the most unmet needs.”

For instance, the law mandates the creation of an advisory group designed to evaluate the applications that come through, Hyun said. And while the committee will review clinical trial results, that’s about where its similarities with other Food and Drug Administration advisory groups stop.

“The objective of this particular external advisory group will be different than in many aspects in the FDA advisory groups,” Hyun said. “They’ll be looking at each of these individual drugs and trying to assign a public health value.”

As for getting Congress on board, Hyun said there will be “some limitations” with the opportunities left, but advocates remain committed to convincing lawmakers of PASTEUR’s value.

“The money is there,” Lillis said. “It’s the political will.”

This post has been syndicated from a third-party source. View the original article here.