Chronic Infection Research Expected to Spark Specialty Pharmacy Growth

With an emphasis on the discovery of infectious determinants of chronic diseases, medical researchers are seeking to reduce chronic disease worldwide. This vital research could lead to earlier prevention and treatment of infection, increase opportunities to avoid irreversible or severe chronic disease across large populations, and make significant advances in regenerative medicine—the process of creating living, functional tissues to repair or replace tissue or organ function lost due to age, disease, damage, or congenital defects.

Although numerous causal relationships are scientifically established, chronic diseases often result from masked chronic infections, which highlights the need for continued research to detect and confirm additional links. It’s important to explore new capabilities to prove causality of chronic infection, open the door to new treatment plans and public health programs, and reduce the number and severity of chronic diseases globally.

This research, which is being conducted by Drs. Marna Ericson and Bob Mozayeni, Fellows with the Thought Leadership & Innovation Foundation (TLI), intersects with the anticipated growth of specialty pharmacy. They are both part of a broader trend in health care: personalized medicine, which tailors medical treatment to the individual characteristics of each patient. This approach relies on scientific breakthroughs in the understanding of how a person's unique molecular and genetic profile makes them susceptible to certain diseases.

TLI’s research is geared toward understanding chronic diseases that are driven by poorly understood, long-term chronic infections that are all potential targets for specialty pharmaceutical solutions. The research is also geared toward improved targeting of therapies and diagnostics to make better use of regular and specialty pharmaceutical products that, ultimately, improve health outcomes faster.

The significance of this research is illustrated here: if only 5% of chronic diseases are attributable to infectious agents, approximately 4.5 million of the 90 million people living with a chronic disease in the United States alone might benefit from new plans and programs.

Biofilms and Their Applications

Specifically, TLI researchers point to the significance of biofilms, which are coherent clusters of multiple bacteria that are more tolerant of popular antimicrobials compared with other bacteria. Biofilms play an important factor in chronic diseases, such as Lyme disease, Bartonellosis, rheumatoid arthritis, lupus, neuropsychiatric diseases, and Crohn disease.

It is now recognized that up to 80% of all bacterial infections in our bodies live in biofilms, which enable bacteria to grow in protective film-covered clusters. These biofilm bacteria often persist undetected and undiagnosed, causing chronic illness by fostering the growth of microbes that contribute to inflammation. Research suggests that biofilms may be unrecognized stages in the pathways from infection exposure to chronic illness and are likely to determine a substantially greater, and potentially preventable, number of chronic illness cases than currently thought.

Possible applications of better understanding biofilms exist in the area of failed artificial joints, often due to infection. Furthermore, this research would also be useful for those exploring a new generation of antibiotics for the increasing number of disease-resistant bacteria.

Proving Causality of Chronic Infection

Infections caused by bacteria have been researched extensively for well over 100 years and those once considered deadly are now controlled or defeated with modern treatments and medicines. However, most of the research conducted to date has targeted acute rather than chronic infections.

Although numerous causal associations are scientifically established, chronic diseases do often stem from infections and continued research is certain to detect and confirm additional links. TLI is currently exploring new capabilities to prove causality of chronic infection. These developments could lead to new treatment plans, public health programs, and could globally reduce the number and severity of chronic diseases.

Because more than 30,000 cases of Lyme disease are reported to the Centers for Disease Control and Prevention each year, in 2016, the 21st Century Cures Act authorized the Department of Health and Human Services to establish a Tick-Borne Disease Working Group to serve as a Federal Advisory Committee. This group is comprised of federal and public members of diverse disciplines and views pertaining to tick-borne diseases, so the time is right for this work.

New strategies, however, must build on sound scientific evidence. Therefore, TLI is establishing a regenerative medicine program with the infrastructure to support the continuation of Ericson’s work and other initiatives in regenerative medicine. The infrastructure needed to support this program includes the establishment of a Clinical Laboratory Improvement Amendments certified laboratory, a state-of-the-art high-powered microscope, consumable materials required for research and clinical work, and the clinical and administrative staff to support the program.

In its quest to continue this important research, TLI is pursuing federal grants, philanthropic donations, and academic partners to join them in the discovery of infectious determinants of chronic diseases, reduce chronic disease worldwide, and make significant advances in regenerative medicine.