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Tuesday, May 28th, 2024

Experts, lawmakers call for improved drug pipeline to treat superbugs

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Antimicrobial resistant (AMR) microorganisms, also known as superbugs, increasingly threaten every person on Earth, according to the World Health Organization (WHO) and national experts.

“Antimicrobial resistance is one of the most urgent health risks of our time and threatens to undo a century of medical progress,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus, who recently called for AMR action across all government sectors and society as new AMR microorganisms emerge and spread globally.

The problem is that AMR microorganisms — like bacteria, fungi, viruses and some parasites — stop antimicrobials — such as antibiotics, antivirals and antimalarials — from working against them, rendering standard treatments ineffective so that infections persist and then spread, resulting in prolonged illness, disability and death.

“Major health care strategies rely on the availability and use of antibiotics, yet the threat of antimicrobial resistance is increasing,” said Kelly Lyn Warfield, vice president of vaccine research and development at Emergent BioSolutions, who cited data from the Centers for Disease Control and Prevention showing that two million Americans contract AMR infections each year, and more than 23,000 die.

Without effective antimicrobials for the prevention and treatment of AMR infections, the WHO says that medical procedures including organ transplantation, cancer chemotherapy, diabetes management and major surgery also become very high risk.

At the same time, a mass casualty event could worsen the situation, Phyllis Arthur, vice president of infectious diseases and diagnostics policy at the Biotechnology Innovation Organization (BIO), said in an interview with Homeland Preparedness News.

“AMR is a major public health problem that poses a national security risk,” said Arthur, who is also an adviser to BIO’s Working to Fight AMR initiative.

In general, any incident that might happen — be it a natural disaster like a hurricane, or a mass shooting, or a biothreat, or a pandemic flu — creates both a large number of injured people and many others who may become exposed to resistant superbugs that can cause complications of an infectious disease nature, she said.

But there’s only a certain amount of antibiotics in the pipeline, which needs to increase alongside the growing list of ever-changing infections and diseases, but which currently isn’t keeping pace, experts say.

“Almost any scenario that you run for a national public health emergency leads to the need for antibiotics,” Arthur said. “So, you’re always up against resistance, and when you have a mass casualty event, it’s exacerbated by the lack of antibiotics.”

In fact, that’s why AMR infections already are considered a threat to the United States, according to former Pennsylvania Gov. Tom Ridge, co-chairman of the Bipartisan Commission on Biodefense.

“While efforts are underway to address this problem, such as what occurs in many of our nation’s hospitals, we are mostly just reacting to the antimicrobial resistance we find after the fact,” Ridge told Homeland Preparedness News. “Awareness of the problem has certainly increased, but we are far from prepared.”

To become better prepared and more able to respond effectively, Ridge recommended that the United States invest in the ability to rapidly develop new medical countermeasures.

“Antimicrobial resistance increasingly threatens our national security. Before, we were mostly just worried about the diseases themselves,” he said. “Now we need to contend with the disease or biological agent and whether we have medical countermeasures capable of combating the illness they cause.”

Arthur agreed and said bad actors increasingly might use drug-resistant pathogens as biothreats against warfighters or civilian populations.

It’s a consideration the Bipartisan Commission on Biodefense also is greatly concerned about, according to Ridge, who said, “the potential for naturally occurring and human-generated antimicrobial resistance … would make preparing for and responding to biological threats even more difficult. The United States has not yet cracked the code in addressing this problem.”

Hence, the BIO Working to Fight AMR campaign supports efforts to increase the development of new antibiotics that treat emerging AMR infections, particularly as many private-sector biotech companies in the space have experienced business-ending challenges due to the lack of a commercial market to support antibiotic research and development.

“Somehow or another, the U.S. government in total needs to help increase and improve the sustainability of the private market for antibiotics,” said Arthur. “The private market, unfortunately, is not working to sustain these products because there are generics that are cheap and, generally, … it’s not a very deep market.”

Another challenge is one faced by companies that are partnering with the federal government to provide drugs that fight AMR infections. Most of their supply is reserved for that pipeline, not the commercial market.

“What we’re seeing is companies going bankrupt,” Arthur said.

The U.S. government is working to combat AMR from many angles, said Warfield with Emergent BioSolutions.

“BARDA in particular funds early-stage discovery for new classes of antibiotics and focuses on strengthening public-private partnerships and facilitating investments to address this threat,” she told Homeland Preparedness News.

Members of Congress also are getting on board to help strengthen the pipeline of effective medications.

For instance, lawmakers this summer introduced the bipartisan, bicameral Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019, S. 1712/H.R. 4100, which would encourage the development and use of DISARM antimicrobial drugs, which are those approved by the U.S. Food and Drug Administration as qualified infectious disease products — such as antibacterial or antifungal biological products — that are licensed to treat serious or life-threatening infections in humans, including resistant emerging or new pathogens, according to the bill’s text.

“Antibiotic- and antifungal-resistant infections are on the rise, and our researchers, physicians, hospitals and other health care providers need every opportunity to advance research and therapies for Americans,” said U.S. Sen. Johnny Isakson (R-GA), who introduced his chamber’s version of the bill. “The DISARM Act would encourage development of new therapies and directly address the challenge of drug-resistant infections in hospitals.”

Specifically, Arthur explained that the proposed bill would address Medicare reimbursements for antibiotics to hospitals, which currently receive them as a bundled payment rather than separately, thereby allowing hospitals to better control costs.

However, because drug-resistant infections are expensive to treat, she said that hospitals need incentivizes to use innovative, more pricey antimicrobials. In turn, lawmakers say the DISARM Act proposes to separate Medicare reimbursement payments from bundled to separate payments for qualified antimicrobials, among other provisions.

“Patients desperately need new antibiotics to treat serious or life-threatening infections caused by antibiotic-resistant bacteria,” said Dr. Cynthia Sears, president of the Infectious Diseases Society of America and professor of medicine at Johns Hopkins University School of Medicine.

“Without new incentives like the DISARM Act, the antibiotic pipeline will continue to crumble,” Sears added.

The measure, which the Working to Fight AMR group considers smart policy, remains under consideration in both houses of Congress.

Meanwhile, experts say there are other proactive measures to take.

For instance, “there are opportunities to improve our response to the threat of antimicrobial resistance,” said Warfield, “including in prescribing practices, making available rapid tests to identify the correct antibiotics to use, and providing appropriate reimbursement for these critically needed drugs.”