Precision Medicine: Advancing the Future of Personalized Healthcare
Our experience when we see our doctor is gradually changing. The days are numbered for routine chemistry panels and other testing done on an annual basis. Envision a scenario where the medical plan from testing, medical treatment, to diet and exercise regimens is tailored specifically for you.
The thought process for this concept began in the early 2000s, while personalized medicine, more appropriately called precision medicine (PM), gained more momentum in 2015. Early in that year, President Barack Obama launched the Precision Medicine Initiative, stating, “Tonight, I am launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes and to give all of us access to the personalized information we need to keep ourselves and our families healthier.”
The Future of Healthcare
Personalized medicine, which has been used interchangeably with precision medicine, is somewhat of a misnomer. There is no paradigm that creates drugs, diagnostic and treatment plans or medical devices that are unique to a single patient. PM does not claim that individual treatment is available for every unique individual. However, PM does use an approach, heavily dependent on technology, that factors in individual variability in genes, environment, socioeconomic status, and the lifestyle of each patient. As is quite well-known, a large part of variability in drug response is genetically determined.
Why does one antibiotic work well for one patient, when failing in another? Why does one patient suffer a catastrophic side-effect on a chemotherapy regimen, when another sails through the therapy with minimal difficulty? The answer is that everyone is unique from a genetic standpoint. The “one size fits all” approach used in traditional medicine is based on large population studies. This approach is imperfect because each patient’s genetic make-up is slightly different from everyone else. The whole system needs to be replaced by something that is more accurate and precise. The answer has become PM.
The Impact of Genetic Testing
Genetic testing has exploded in the last decade, and it has become less expensive, more efficient, and quicker to perform. One only needs to turn on the television or view a social media post to see how popular products like Ancestry.com or 23andME have become recently. Pharmacogenetics blends genetics, biochemistry, and pharmacology and focuses on how genetic variations influence the metabolic pathways activating or altering drugs, and how individuals respond to specific regimens based on their genetic make-up.
This has been a catalyst in PM and is an extension of traditional approaches to medicine. This approach to treatment and prevention considers individual variability in genes, the microbiome, environment, and the lifestyle of each person. The information contained in the cells of the biopsy from “your tumor” will be used to tailor therapy for you. This is not a futuristic scenario; it is occurring every day in 2021.
The gut microbiome consists of bacteria, fungi, and other microorganisms that reside in the human digestive tract. The microbiome composition varies among individuals, and we each have our own unique microbiome “fingerprint”. Gut microbiota plays a role in an individual’s overall well-being via modulating metabolism and immune function. Animal and human studies have suggested that changes in composition and function of gut microorganisms are associated with obesity and diabetes. A recent study published in the Journal of the American Society of Microbiology found that gut microbiome genes associated with bacterial replication and breakdown of carbohydrates predicted weight loss response. Such research could lead to diagnostic techniques and individualized treatments for people looking to lose weight. In this author’s opinion, we are just “scratching the surface” in studying and harnessing the potential of the Microbiome.
How Clinical Research is Advancing the Future of Medicine
As PM has developed, or rather evolved, it opens exciting new advances in providing patient care. With acquired knowledge derived from the principles of PM, we have seen improvements in disease detection, and it has become possible to disrupt or pre-empt disease progression. Using pharmacogenomics, PM has led to selecting optimal pharmacological therapy while reducing the “trial and error” prescribing patterns that have been the norm for decades. In short, we can prescribe more effective drugs, and avoid prescribing drugs with predictable side effects. Before prescribing a medical regimen, a provider can access the patient’s genetic profile, and thus assess whether that patient is “wired” for maximal efficiency and minimal likelihood of side effects from said regimen. To a large extent, the “guesswork” that has previously been part of the decision process regarding medical therapy is all but eliminated.
PM must work in concert with cutting edge research. Clinical trials, carefully employing the fundamentals of PM will be the engine that advances the future of medicine as a profession/discipline. Trials, such as those currently being conducted by ObjectiveHealth are testing and validating many medications and diagnostic regimens. Clinical research will forge the way to unlocking the future principles that will guide effective clinical decision making, allowing the practice of medicine to change from a reactive to a proactive/preventative model. ObjectiveHealth is effectively using its proprietary technology and advanced analytics to conduct clinical research that is guiding new standards of care in clinical decision support systems.
The Mutual Benefits of Clinical Research and Precision Medicine
Establishing a successful research program in conjunction with traditional medical practices has historically been quite difficult. Regulatory requirements and administrative costs in time and money can be overwhelming for practices without the resources and support structure to meet these challenges. Most clinicians feel that clinical research disrupts their ability to care for their patients, both efficiently and effectively. Many question “why do I bother?” The answer is that incorporating clinical research into a practice has true value to both patients and physicians.
Patients want access to novel, “cutting edge” therapy. They want their health care team to offer the best available therapies that exist. ObjectiveHealth presents an approach that allows the practicing physician to conduct research within their practice without the typical administration and regulatory burdens. Our model benefits both providers and patients from a cost, quality and satisfaction standpoint. Patients that can participate in trials conducted by their own physician, in proximity to their home are more likely to remain engaged and to have a positive outcome. Potential benefits from research include improved quality of care and patient satisfaction.
A patient will be far more receptive to receiving trial related care by their own physician, and such a situation would facilitate clinical communication and improve care management. Clinical trials will also make available treatments that would not otherwise be available, and or affordable to uninsured patients. Today’s patients are a more informed group, and often seek providers that offer more than a standard office visit. ObjectiveHealth partners differentiate themselves from other medical practices in their respective markets and are committed to be at the forefront of medicine.
Our Way Forward
In summary, PM is not a new concept. It has been around for over a decade, and it grows in breadth and complexity every day. Doctors and researchers, by virtue of what PM has taught us, can more effectively use genetic information to better predict which treatments will work best for specific subsets of patients, and better understand the underlying mechanisms of various disease processes. This will only lead to better approaches to preventing, diagnosing, and treating disease in general.
Integrating the approach of PM into the technology and strategy used to treat patients and aligning with ObjectiveHealth as a research partner, will allow acquisition of important new data and treatments that benefit patients and improve all aspects of medical care.
- R. Vogenberg et al Pharmacy and Therapeutics October 2010
- IT Analytics Jennifer Bresnick 1/11/18
- Francis Scallion, NEJM 2015 372: 793-795
- Shen,J et al “Clinical research participation as a care option: Driving patient experience and satisfaction” Quintiles.com 2015.
- Getz, Kenneth A. “Examining and Enabling the Role of Health Care Providers as Patient Engagement Facilitators
- Sean Gibbons et al. “Baseline Gut Metagenomic Functional Gene Signature Associated with Variable Weight Loss Responses following a Health Lifestyle Intervention in Humans” ASM, September 14, 2021