Challenges and prospects for biomarker research: a current perspective from the developing world.

The concept of personalized medicine has been around for as long as people have been practicing medicine. From Charaka to Hippocrates, all have practiced the personalized approach for treating a disease. In the 21(st) century, personalized medicine is all about DNA. Whereas the single nucleotide polymorphism (SNP) and epigenetic factors influence drug response and form the basis of personalized medicine, the tridosha theory forms the basis of Prakriti-based medicine. It is well established by now that western allopathic medicine is excellent in handling acute medical crises, whereas Ayurveda has successfully demonstrated an ability to manage chronic disorders that Western medicine has been unable to cure. With effective integration of 'omics' Prakriti-based medicine can play a vital role in this changing scenario of global health wisdom as Ayurveda offers its modalities by way of ahara (diet), vihara (lifestyle), and aushadhi (medication), which are the three pillars of prakriti-based medicine making it a holistic science. Prakriti-based medicine and other traditional medicine systems have the potential to offer remedies to the challenging health issues like adverse drug reactions, drug withdrawals, and economic disparities among few. An integrative global approach could do wonders to health sciences benefiting a broad spectrum of patients.

Prakriti-based medicine: A step towards personalized medicine.

The value of health care can be increased tremendously through individualized medicine. With the promise of individualized medicine, healthcare professionals will be able to better predict disease risk, prevent development of disease and manage treatments more efficiently thereby allowing people to be healthier and active longer. The developments in the area of pharmacogenetics/pharmacogenomics can help the physicians achieve the target of personalized medicine. Personalized medicine will come to mean not just the right drug for the right individual, but the right drug for the specific disease affecting a specific individual. The use of personalized medicine will make clinical trials more efficient by lowering the costs that would arise due to adverse drug effects and prescription of drugs that have been proven ineffective in certain genotypes. The genotypic experiments have laid valuable insights into genetic underpinnings of diseases. However it is being realized that identification of sub-groups within normal controls corresponding to contrasting disease susceptibility could lead to more effective discovery of predictive markers for diseases. However there are no modern methods available to look at the inter-individual differences within ethnically matched healthy populations. Ayurveda, an exquisitely elaborate system of predictive medicine which has been practiced for over 3500 years in India, can help in bridging this gap. In contrast to the contemporary system of medicine, the therapeutic regimen in Ayurveda is implicated on tridoshas and prakriti. According to this system, every individual is born with his or her own basic constitution, which to a great extent regulates inter-individual variability in susceptibility to diseases and response to external environment, diet and drugs. Thus the researchers in India have demonstrated that integration of this stratified approach of Ayurveda into genomics i.e. Ayurgenomics could complement personalized medicine.

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Pharmacogenetics, pharmacogenomics and ayurgenomics for personalized medicine: a paradigm shift.

Genomics has ushered in a phase of predictive, preventive and personalized medicine (PM), and several attempts are being made to detect genetic variations that are responsible for susceptibility to diseases and varied response to medications, however, have met with only a limited success. Ancient Indian system of medicine, Ayurveda, strongly emphasize on personalized patient care under the concept of Prakriti (phenotype-based human constitution). We would therefore like to put forward a new dimension of PM—the ‘Prakriti-based medicine’ bearing testable molecular and genetic correlates. Current investigations in the field of genomics, PM and Ayurveda have inspired many researchers and started in-depth deliberation on how Prakriti (phenotype-based Ayurveda constitution) is associated with the field of genomics, biochemistry, psychology, physiology and therapeutics. Various genotypes have also been correlated with Prakriti. Studies have shown wide range of utilities of Prakriti assessment in therapeutics, i.e. from predicting disease susceptibility of an individual, prevention of impending diseases, early diagnosis through screening of the high risk, rational drug designing, customization of therapy (drug, diet and lifestyle) and health maintenance. Ayurvedic Prakriti-based treatment resonates with PM and pharmacogenomics and holds potential and promise for future predictive or preventive medicine. Further studies are warranted towards integrating or complementing genomics and contemporary medical science with Prakriti and explore the future possibilities.

Predictive, Preventive and Personalized Medicine: Leads From Ayurvedic Concept of Prakriti (Human Constitution)

Cardiovascular biomarker research efforts have resulted in the identification of new risk factors and novel drug targets, as well as the establishment of treatment guidelines. Government agencies, academic research institutions, diagnostic industries, and pharmaceutical companies all recognize the importance of biomarkers in advancing therapies to improve public health. In drug development, biomarkers are used to evaluate early signals of efficacy and safety, to select dose, and to identify the target population. The United States Food and Drug Administration has relied on biomarkers to support clinical applications in many therapeutic fields, including cardiovascular disease. The appropriate application of cardiovascular biomarkers requires an understanding of disease natural history, the mechanism of the intervention, and the characteristics and limitations of the biomarker. Channels of communication among researcher, developer, and regulator must remain open to maximize the success of future biomarker ...

Vascular Biomarkers and Surrogates in Cardiovascular Disease

US Senator Barack Obama recently proposed the Genomics and Personalized Medicine Act of 2006, which should it be enacted, would establish a Genomics and Personalized Medicine Interagency Working Group to coordinate personalized medicine efforts, fund genomics research to improve drug safety and establish a US Biobanking Research Initiative similar to efforts deployed in other countries. But what impact could personalized medicine have on the drug development process, the pharmaceutical industry and international health, including that in developing countries? Can personalized medicines support innovation, sustainability and growth in the pharmaceutical industry and also respond to changing world realities, emerging public demands for safer and more efficacious medicines and equitable access to pharmaceuticals? The present paper examines these socio-ethical and science policy questions by first elucidating their in- trinsic and often complex interactions with other economic and policy issues (and the often divergent interests of stakeholders). We then present some examples from other industries (e.g., the case of hybrid cars and attendant growth of consumer interest and confidence in high quality sustainable products), with a view to identifying the factors that might contribute to a successful integration of pharmacogenomics and related biomarker technologies in patient care, interna- tional health and public policy. In particular, we propose ways to integrate the concept of sustainability into corporate and investor models of pharmaceutical industry development. While the power of pharmacogenomics to serve as a driver for the pharmaceutical industry remains to be evaluated, we submit that biomedical innovation and economic prosperity can co-exist with ethical drug development and the sustainable commercialization of customized drug therapies.

Personalized Medicine, Bioethics and Social Responsibilities: Re-thinking the Pharmaceutical Industry to Remedy Inequities in Patient Care and International Health

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Personalized Medicine, Bioethics and Social Responsibilities: Re-thinking the Pharmaceutical Industry to Remedy Inequities in Patient Care and International Health