More than 50 groups marshalled by the Infectious Diseases Society of America (IDSA) seek an act of Congress to rush urgently needed new antimicrobial drugs to market that protect America’s national security and the health of its citizens against biothreats posed by antimicrobial resistant (AMR) pathogens.
An antimicrobial or antibiotic, according to the Centers for Disease Control and Prevention (CDC), is a type of drug that kills the growth of microbes such as bacteria, viruses, fungi and parasites. AMR is the ability of microbes to resist the drugs, in turn allowing the germs to grow. Infections having resistant organisms are difficult to treat, requiring expensive and sometimes toxic alternatives, the CDC says.
“Bacteria will inevitably find ways of resisting the antibiotics developed by humans, which is why aggressive action is needed now to keep new resistance from developing and to prevent the resistance that already exists from spreading,” according to the CDC.
That’s why so many entities — including those representing health care providers, hospitals, medical societies, public health organizations, patient groups, pharmacists, scientists and other industry stakeholders and experts — told members of Congress this month that they “are deeply concerned about the serious threat [AMR] pathogens pose … and are alarmed by the insufficient number of new antimicrobials and diagnostics to combat that threat.”
As a solution, IDSA and the groups have called upon federal lawmakers to include a new economic incentive to spur the development of AMR drugs in upcoming legislation that reauthorizes the Pandemic and All Hazards Preparedness Act (PAHPA), Amanda Jezek, senior vice president of public policy and government relations for IDSA, told Homeland Preparedness News.
“With Congress planning to reauthorize PAHPA, the groups we have mobilized want to bring to members’ attention that antimicrobial resistant pathogens are a key threat that needs to be addressed as part of this reauthorization,” which has a Sept. 30 deadline, Jezek said.
During potential terror attacks or chemical events in which there may be mass injuries sustained, open wounds including burns, abrasions, or gunshots, among others, all could become easily infected, Jezek explained.
“We would be unable to treat a large number of these infections because there are not enough new antibiotics being developed to treat the new strains,” she said.
Oftentimes with influenza, most related deaths are due to secondary pneumonia. “The same is true with infections caused by antimicrobial resistant pathogens that lead to death,” said Jezek, “so we want to spur the development of drugs for this particular type of response.”
And swifter development of AMR drugs is needed pronto, according to those that signed on to the letter released by IDSA, including Pfizer Inc., March of Dimes, the Association for Professionals in Infection Control and Epidemiology, Merck, GlaxoSmithKline, the Duke Center for Antimicrobial Stewardship and Infection Prevention, the Emory Antibiotic Resistance Center, Johns Hopkins Center for Health Security, the Global Health Technologies Coalition, American Public Health Association, American Society for Microbiology, American Society of Hematology, American Society of Nephrology, American Society of Transplant Surgeons, and the American Society of Tropical Medicine and Hygiene, among many others.
“More and more Americans are contracting serious and life-threatening infections that are difficult and sometimes impossible to treat, resulting in longer hospital stays, complications of medical treatments such as surgery and chemotherapy, and deaths,” according to their Feb. 6 letter, which was sent to U.S. Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.), chairman and ranking member, respectively, of the Senate Health, Education, Labor and Pensions Committee, and U.S. Reps. Greg Walden (R-Ore.) and Frank Pallone Jr. (D-N.J.), chairman and ranking member, respectively, of the House Energy and Commerce Committee.
“Patients with weakened immune systems, such as those with HIV/AIDS, preterm infants, cancer patients, organ transplant donors and recipients, the elderly, or patients treated in intensive care units are at heightened risk, but even healthy young people are contracting and dying from serious, resistant infections,” the signers noted in their letter.
In fact, at least 23,000 Americans die annually from AMR infections and another 2 million people become seriously ill, costing the U.S. health care system roughly $20 billion in excess costs, according to CDC estimates.
America’s national security likewise is at risk from the threat of AMR germs and bugs, write IDSA and the other companies and organizations in their letter, specifically by complicating soldiers’ combat wounds, for example, and increasing the risk of limb loss and death, which compromise the U.S. military’s combat readiness and effectiveness.
“Between 2004 and 2009, over 3,300 American soldiers in Iraq and Afghanistan became severely ill from a single resistant pathogen — Acinetobacter, which has become even more resistant to treatment over time,” they wrote the lawmakers.
Even worse, they wrote, AMR pathogens also are prime candidates for weaponization by state and non-state enemies of the United States. “Studies have concluded that the aerosolized release of a weaponized, resistant pathogen in just a single incident of bioterrorism in the Washington, D.C., area would result in a death toll of over 3 million” people, according to the letter, which noted that a coordinated bioterrorist attack using a weaponized AMR pathogen would result in comparably many more deaths.
“AMR also puts our health security at risk, both within the U.S. and globally,” according to the letter. “An outbreak of a serious resistant infection with limited or no treatment options could overwhelm health systems, harm economies and even destabilize communities or entire countries.”
Therefore, including new incentives in the updated PAHPA could provide “the robust and renewable antimicrobial drug pipeline needed to ensure our safety,” according to the letter.
And although the many letter signers acknowledged the support of the Biomedical Advanced Research and Development Authority (BARDA) toward antimicrobial research and development, they told federal lawmakers that significant unmet needs persist.
“BARDA has had a really important role in supporting such development thus far,” Jezek told Homeland Preparedness News. “But what it’s doing currently is not enough. “The government needs to include more incentives and get more companies into R&D.”
Along with the CDC, the President’s Council of Advisors on Science and Technology, the World Health Organization, the United Nations and other expert bodies and individuals also have documented the urgent crisis of AMR and called for investments in antimicrobial R&D.
Jezek explained that antimicrobial research and development has dwindled because most pharmaceutical companies have left the market. The drugs that get produced from such R&D are usually inexpensive, used for short time spurts and then held in reserve to protect their utility — which combined prevents opportunities to earn a return on R&D investment.
“Many companies have backed away from R&D because it’s not profitable and they can barely get a return on their investments,” she said. “We’re hoping to have this issue addressed in the PAHPA reauthorization, as well.”
Economic incentives could help such companies “overcome the hurdles that continue to hamper antimicrobial R&D,” according to the letter.
Going forward, Jezek said IDSA will continue to meet with congressional officers and staff members on the issue.
“There is strong bipartisan support on investing more and an interest in doing something to turnaround the situation,” she said. “But there’s a reason for the cliché that it takes an act of Congress to get things done so I’m always cautious in making predictions about any legislative outcomes.”