Is legislation to protect Americans against superbugs a breakthrough or a breakthrough?  - MedCity News

With time running out on the 2022 session of Congress, a bipartisan coalition of lawmakers and infectious disease experts is scrambling to pass a bill aimed at boosting the development of antibiotics to combat the deadly spread of drug-resistant pathogens.

The PASTEUR Actas amended, would provide $6 billion in federal funding over several years to give drugmakers an incentive to develop and produce life-saving drugs for the small but growing number of highly antibiotic-resistant infections.

A set of supporters in the health and drug sectors say the measure will correct “broken market” for antibiotics by providing stable funding for an industry that tends to focus its research on areas considered to be good business opportunities. In recent years, most major pharmaceutical companies have abandoned antibiotic development due to weak sales and several smaller ones involved in the work declared bankruptcy.

But there is also the measure persistent critics in the medical community, who deride it as a multi-billion dollar piece of crap and a Big Pharma giveaway. They argue that this will not solve the long-term problem of relying on profit as the primary motive for antibiotic discovery and development.

“This is a very smart maneuver to get taxpayers to bail out an industry that is failing,” said Dr. Brad Spielberg, an infectious disease specialist and chief medical officer at Los Angeles County + USC Medical Center. “If the government is going to spend money on this, it should spend it wisely.”

The PASTEUR Act, which stands for Pioneering Antimicrobial Subscriptions to End Emerging Resistance, was introduced by Senators Michael Bennett, Democrat of Colorado, and Todd Young, Republican of Indiana, and in the House of Representatives by Representatives Mike Doyle, Democrat of Pennsylvania, and Drew Ferguson, Republican of Georgia. It has more than 65 bipartisan co-sponsors in both chambers.

Those for and against the bill agree that antimicrobial resistance is a critical problem that the federal government must address. Superbugs that cannot be treated kill more than 35,000 Americans and about 1.27 million people worldwide each year.

While drug companies can make billions from drugs that patients take for months or years, such as cancer therapies and cholesterol-lowering drugs, the industry often loses money on antibiotics that are prescribed for just a few days or weeks, said Amanda Jezek, senior vice president for public policy and government relations at the Infectious Diseases Society of America.

Hospitals are trying to use fewer antibiotics, the use of which encourages the growth of resistant organisms, and are especially hesitant to use newer antibiotics that target highly drug-resistant microbes. That’s because such bacteria infect a small proportion of patients, and widespread use of the new drugs would only cause more mutations and resistance, Jezek said.

“When someone makes a new antibiotic, the first thing infectious disease doctors say is, ‘Don’t use it,'” said Dr. Amesh Adalya, a senior scientist at Johns Hopkins University’s Center for Health Security who helps oversee antibiotic use. in his hospital. “We have to keep it until we really need it because we don’t want to lose this medicine.”

Instead of paying per pill for antibiotics—a practice that encourages companies to promote their use—the PASTEUR Act would allow the federal government to pay lump sums for promising FDA-approved drugs that could then be administered to patients covered by government insurance programs such as Medicare and Medicaid. Such payments would provide manufacturers with enough income to cover their costs for these drugs, even if they are rarely used.

But critics, including Public Citizen, say the PASTEUR Act offers the pharmaceutical industry what windfall, without sufficiently rigorous standards to ensure that new drugs are truly safer and more effective than existing ones. And they quote recent study showing that the majority of hospital deaths in patients with invasive bacterial infections are caused by treatable bugs, often in very old or frail patients.

Opponents also argue that drugmakers now have access to financial incentives to create antibiotics. Federal agencies, including the National Institutes of Health and the Biomedical Advanced Research and Development Authority, have invested hundreds of millions of dollars over the past decade in antibiotic research. Drug manufacturers also have access to funding from non-profit organizations such as CARB-X and Welcomeas well as public-private partnerships such as AMR Action Fund.

Congress and the FDA in recent years have made it easier for companies to get approval for antibiotics and extend their marketing exclusivity.

The problem isn’t funding, but rather a lack of strict approval standards at the FDA, said Dr. Reshma Ramachandran, an assistant professor at Yale School of Medicine.

The FDA approved 15 new antimicrobial drugs between 2016 and 2019. But recently published study shows that these drugs often do not appear to be more effective than older drugs, even though companies charge up to 100 times more for them.

That explains why these drugs aren’t being sold, said Dr. John Powers, a former FDA official, a clinical professor at George Washington University School of Medicine and one of the study’s authors. “Insurers don’t pay, doctors don’t use them because the evidence doesn’t show that patients do better with them than the older drugs.”

Powers argues that FDA reviews of new antibiotics don’t put enough emphasis on how they benefit patients. In one clinical trial of cefiderocol, for example, the drug was better at killing bacteria, but 34% of patients taking it died, compared with 18% taking older drugs. The FDA approved cefiderocol under a policy that allows new drugs to be approved even if trials show they are less efficient than the old ones by as much as 10%.

“We need evidence that these drugs improve patient outcomes,” Powers said. “They can kill more bacteria, but doctors don’t treat bacteria, doctors treat patients.”

Spielberg and other researchers proposed an alternative. A federally funded non-profit organizationor a few nonprofits endowed with $1 billion to $2 billion could fund antibiotic research for decades, Spellberg predicted. Board made up of patient advocates, doctors, industry representatives and others, will regularly update an official list of pathogens to target to ensure that taxpayer money is used where it is most needed.

Each nonprofit will include microbiologists, medicinal chemists and pharmacologists “all under one roof,” Spielberg added. “They wouldn’t focus on one drug per se. They will focus on the discovery and development of new, impactful technologies.”

Supporters counter that the PASTEUR Act already includes built-in quality control.

The bill would create a committee, much like the dashboard Spellberg offers to identify the most dangerous superbugs. PASTEUR will also fund $500 million in federal grants to help hospitals improve antibiotic stewardship — programs that manage their use to prevent the spread of resistant organisms — prioritizing rural and safe hospitals that serve patients with low incomes.

The Great Britain adopted a similar program that supporters hope will demonstrate the effectiveness of subscription models.

Even PASTEUR supporters, such as Dr. Thomas Frieden, former director of the Centers for Disease Control and Prevention, note that antimicrobial resistance is a complex, long-term problem that must be attacked on many fronts.

Hospital controls over antibiotic use have dramatically reduced the prevalence of one class of “nightmare bacteria,” the carbapenem-resistant Enterobacterales. Other tools, such as new vaccines, could reduce bacterial threats, he said. Doctors could also prescribe fewer antibiotics if they had rapid tests that would allow them to quickly distinguish viral from bacterial infections and determine which bacteria have mutations that require a special approach.

“The idea here is not to offer one superior best antibiotic,” said Dr. Cornelius Clancy, a professor of medicine at the University of Pittsburgh who supports the PASTEUR Act. “It’s a question of having a pipeline.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism on health issues. Along with policy analysis and polling, KHN is one of three major operational programs in the KFF (Kaiser Family Foundation). KFF is a charitable, non-profit organization providing information on health issues to the nation.

This story may be republished for free (details).

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism on health issues. Along with policy analysis and polling, KHN is one of three major operational programs in the KFF (Kaiser Family Foundation). KFF is a charitable, non-profit organization providing information on health issues to the nation.

Photo: Rawf8, Getty Images

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