The emergence of organisms resistant to commercially available antibiotics has created a public health crisis, and a gap has emerged between the clinical and perceived value of antibiotics. The subject of hospital acquired infections (HAIs) also has become a frequent topic for discussion among patients, families, clinicians, and hospital administrators. The emotional and financial burdens associated with HAIs are deeply felt, by patients and infection control specialists.
Continued emphasis on appropriate antibiotic prescriptions for bacterial infections to prevent overuse is essential. Physicians are responsible for carefully educating patients on the rationale for the use of antibiotics.
Although infectious diseases cross all medical specialty boundaries, the antibiotic research industry has not kept up with the advancing state of antibiotic drug resistance. Between 1983 and 1992, about 30 new antibiotics were brought to market. But from 2003 to 2012, the Food and Drug Administration approved only six.
Their value is unquestioned. Countless people over many decades have required the use of antibiotics for acute illnesses and chronic conditions. In the 15 years after the introduction of penicillin, the death rate from infections in the United States declined by 220 per 100,000 infection cases. Between the years of 1958 and 1990, all other medical technologies reduced deaths by 20 per 100,000. The global use of these medications has improved the quality and length of life, and they play a crucial role in hospital care, long-term care settings and outpatient facilities. A 1944 white paper after the introduction of penicillin suggested antibiotic use would run from "cradle to grave," forecasting the necessity for long-term antibiotic development.
Many older Americans have conditions which make them susceptible to HAIs as well as infections that result from their specific illnesses and therapy. Oncology treatments would have poor outcomes if antibiotics were unavailable, because cancer and the required chemotherapy weaken the immune system and open the door to infections. But even when the best infection control practices are followed, clinicians will continue to face challenges battling HAIs and drug resistance.
The pharmaceutical industry’s Innovative Medicines Initiative (IMI) has invested time and money to encourage collaboration among pharmaceutical companies and research centers to evaluate new products in the fight against multi-drug resistant organisms (MDROs). In June 2012, Congress announced new incentives to advance antibiotic development in the form of the “Generating Antibiotic Incentives Now (GAIN) Act,” a bill to expedite the approval of antibiotics against challenging resistant pathogens.
In the meantime, however, the urgent unmet health-care problem of hospital- and community-acquired drug resistant infections continue to threaten patients. In the real-world of patient care, MDROs and chronic conditions make treatment guidelines less useful in treatment decisions. The balance between treating, curing, and extending life requires careful consideration outside of policy-making settings. Active and urgent attention is needed to address HAIs and extensively drug-resistant organisms.
In order to truly evaluate the impact on broad spectrum antibiotics, reimbursement must be aligned with the outcomes the drugs can provide. It may take expensive newer agents to boost the return on investment and reinvigorate the pharmaceutical industry in this field of research. Other diseases, such as diabetes, kidney disease, cancer and heart disease have fund-raising charities that contribute to research. No such thing exists for antibiotics, yet infections cross all medical specialties.
Requiring all acute care hospitals and long-term care facilities to register and actively participate in the National Healthcare Safety Network Emerging Infections Program (NHSN EIP) is a necessary step to track HAIs in real-time. Sound clinical research and contributions from the community in such studies will assist in the development of new prevention and therapeutic strategies. Collaborative efforts among volunteers, industry, academia, and the government will be necessary to evaluate new vaccines and antibiotics.
Steve Poretz is executive director of the Clinical Alliance for Research & Education – Infectious Diseases (CARE-ID), a private clinical research center that evaluates preventive vaccines and therapies for infectious diseases. The organization is associated with Infectious Diseases Physicians Inc., a private practice in Annandale, Va.