The concept of ‘Precision Medicine’ has started gaining increasing importance, in the treatment process of many serious diseases, such as cancer. It is now happening in many countries of the world, including India.
The National Institutes of Health (NIH) of the United States, describes ‘Precision Medicine’ as:
“An emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.”
This is quite in contrast to the widely practiced “one-size-fits-all” type of drug treatment approach, where disease treatment and prevention strategies are developed for the average person, with less consideration for the differences between individuals.
It continues, irrespective of the fact that the same drug doesn’t always work exactly the same way for everyone. It can be difficult for a physician to predict, which patient will benefit from a medication and who won’t, besides having any advance inkling on who will experience Adverse Drug Reactions (ADR) with it, and who will not.
Whereas, the treatment path of ‘Precision Medicine’ allows doctors to predict more accurately which treatment and prevention strategies will work most effectively for a particular disease, and in which groups of people. This is mainly because, ‘Precision Medicine’ looks at the root cause of the ailment for each patient.
For example, in cancer care, use of the term ‘Precision Medicine’ would mean a treatment process for patients with similar tumors, that has been immaculately worked out in accordance with their unique genetic, physical, psychosocial, environmental, and lifestyle factors. Thus, especially for the treatment of life-threatening diseases, a gradual shift from “one-size-fits-all” types of medicines to ‘Precision Medicines”, could bring a new hope of longer survival or remission, for many such patients.
For example, in precision cancer care, it is all about analyzing a patient’s tumor to determine with specificity what drug or combination of drugs will work best with least side effects for that particular individual.
In this article, I shall focus on the development, use and benefits of ‘Precision Medicine’ in cancer, especially in India.
Not a radically new concept:
Several examples of ‘Precision Medicine’ can be found in a few other areas of medicine, as well, though its use in everyday health care is not very widespread, as on date.
One such example can be drawn from the blood transfusion area. A person requiring it, is not given blood from a randomly selected donor. To minimize the risk of any possible post-transfusion related complications, the blood for transfusion is selected only after scientific confirmation that the donor’s blood type matches to the recipient.
Difference between ‘Precision’ and ‘Personalized’ Medicines:
There is a significant overlap between these two terminologies. According to the National Research Council (NRC) of the United States, ‘Personalized Medicine’ is an older term having a meaning similar to ‘Precision medicine’, but may not always be exactly the same.
This change was necessitated as the term ‘Personalized’ could be interpreted to imply that treatments and preventions are being developed uniquely for each individual. Whereas, in ‘Precision Medicine’, the focus is on identifying which approaches will be effective for which patients based on genetic, environmental, and lifestyle factors, as stated above. The NRC, therefore, preferred the term ‘Precision Medicine’ to ‘Personalized Medicine’ to avoid such confusions or misunderstandings. Nevertheless, these two terms are still being used interchangeably.
Another terminology – ‘Pharmacogenomics’ is also used by some, in the same context, which is, in fact, a part of ‘Precision Medicine’. According to National Library of Medicine, United States, Pharmacogenomics is the study of how genes affect a person’s response to particular drugs. This relatively new field combines pharmacology (the science of drugs) and genomics (the study of genes and their functions) to develop effective, safe medications and doses that will be tailored to variations in a person’s genes.
Global initiatives taking off:
Currently, in various parts of the world, there are many initiatives in this area. However, one singular state sponsored initiative, I reckon, is exemplary and stands out.
According to NIH, in early 2015, President Obama announced a research effort focusing on bringing ‘Precision Medicine’ to many aspects of health care. The President’s budget for fiscal year 2016 included US$216 million in funding for the initiative for the NIH, the National Cancer Institute (NCI) – the NIH institute focused on cancer research, and the Food and Drug Administration (FDA).
‘The Precision Medicine Initiative’ has both short-term and long-term goals:
- The short-term goals involve expanding precision medicine in the area of cancer research. Researchers at the NCI hope to use this approach to find new, more effective treatments for various kinds of cancer based on increased knowledge of the genetics and biology of the disease.
- The long-term goals focus on bringing ‘Precision Medicine’ to all areas of health and healthcare on a large scale.
The market:
According to a July 2016 research report by Global Market Insights, Inc., the ‘Precision Medicine’ market size was over US$39 billion in 2015, and has been estimated to grow at 10.5 percent CAGR from 2016 to 2023, expanding the market to US$ 87.79 billion by end 2023.
The demand for ‘Precision Medicine’ is expected to significantly increase, specifically in cancer treatments, and also would be driven by advancements in new healthcare technologies, and favorable government regulations, in this area.
Faster US regulatory approval:
According to an August 15, 2016 article, published in the ‘MedCity News’ – a leading online news source for the business of innovation in health care, companion diagnostics, this trend is gaining currency as novel drugs are being paired up with tests that determine which patients will have a higher chance of responding to that drug.
This is vindicated by an expert analysis of a recent study, which found that the probability of a drug approval jumped three-times to 25.9 percent of those drugs that were approved with a predictive biomarker, from 8.4 percent for drugs without one. This means a threefold increase in success, as determined by FDA registration, if any pharma or biologic drug company had a predictive marker in its new product development strategy. This indication would expectedly encourage more drugs to come with companion diagnostics than without, as the analysis underscored.
The National Institutes of Health (NIH) of the United States defines ‘Biomarkers’ or ‘Biological Markers’ as, “a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacological responses to a therapeutic intervention.”
‘Precision Medicine’ in India:
In the Indian health care space, ‘Precision Medicine’ is still in its nascent stage. This is despite its need in the country being high, especially while treating life threatening ailments, such as cancer, with greater precision, predictability and, therefore, more effectively than at present........
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