Title: Threat of Drug-Resistant Bacteria and Need for Congressional Action Highlighted by Experts
The increasing threat of drug-resistant bacteria, also known as antimicrobial resistance (AMR), poses a significant risk to vulnerable patients. Experts have urged Congress to take action in order to address this pressing public health issue. Testifying before the Senate Health, Education, Labor, and Pensions Committee on July 11, Melinta Therapeutics President and CEO Christine Ann Miller emphasized that AMR is not a distant concern but an immediate one.
Ms. Miller noted that in the United States, AMR is the third-leading cause of death, trailing only heart disease and cancer. The situation has worsened since the COVID-19 pandemic, as hospital-acquired drug-resistant infections and related deaths increased by approximately 15 percent. This setback effectively erased years of progress in combatting superbugs, bacteria that have developed resistance to antibiotics.
Ms. Miller attributed the problem to reimbursement and access challenges unique to antimicrobial drugs, rather than a lack of innovation or regulatory obstacles. These challenges often deplete funds for biotech companies even after their products have been approved. However, she stressed that Congress could address the issue by enacting reimbursement reforms and implementing incentives to support the development of new antibiotic drugs.
Melanie Lawrence, a resident of Fairhaven, Massachusetts, highlighted the urgency of combating antimicrobial resistance due to her own struggle with cystic fibrosis. Cystic fibrosis, a progressive and incurable genetic disease, causes the body to produce thick, sticky mucus that can lead to blockages, infections, and damage to organs. Individuals born with the condition today have an average life expectancy of 56 years. Ms. Lawrence stressed the need to live life to the fullest, describing her daily routine of taking medication, undergoing therapy, and focusing on creating meaningful memories with her 12-year-old son.
After years of treatment with various antibiotics, Ms. Lawrence’s lung bacteria have become resistant to almost all available antibiotics, excluding tobramycin. Unfortunately, she cannot use tobramycin due to hearing and kidney damage resulting from a clinical trial. As a result, Ms. Lawrence focuses on managing her symptoms while striving to maintain the best possible quality of life. She expressed her fear and anxiety about the constant threat of bacterial infections and the possibility of leaving her son without his primary caregiver.
According to the Centers for Disease Control and Prevention (CDC), over 2.8 million antibiotic-resistant infections occur annually in the United States, resulting in more than 35,000 deaths. In response to this crisis, bipartisan legislation known as the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act has been introduced in Congress. This bill aims to incentivize the development of new antibiotics, increase their availability, and enhance national reporting on appropriate antibiotic usage.
Dr. Helen Boucher, dean and professor of medicine at the Tufts University School of Medicine, highlighted the unique features of the PASTEUR Act. She emphasized that the legislation values antibiotics for their effectiveness rather than their utilization, preventing the incentives for their overuse. The proposed subscription-based payment model would provide upfront payments to antibiotic developers in exchange for access to their drugs. Developers must meet specific criteria linked to stewardship to benefit from this reimbursement system, ensuring optimal antibiotic usage and preservation.
Both Ms. Miller and Ms. Lawrence voiced their support for the PASTEUR Act, emphasizing the importance of ongoing antibiotic development and innovation in saving lives. Ms. Lawrence underscored the global nature of the problem, urging proactive action by Congress.
The threat of drug-resistant bacteria and the urgent need for Congressional intervention to address the issue have been highlighted by experts. The proposed PASTEUR Act, with its innovative reimbursement model and focus on stewardship, represents a crucial step toward mitigating the risks associated with AMR. By fostering ongoing antibiotic development and implementing effective policies, lives can be saved and the public health crisis can be addressed.
