Pharmacogenomics is an emerging field of study of pharmacology. It is a combination of biochemistry that helps in the production of drugs, and genomics which evaluate an individual's variations in proteins and genes. The goal of pharmacogenetics, its alternate term is to customize drugs to fit each individual after assessing his genetic makeup and protein variations.
Through evaluation of certain proteins and genes of diseases, medicines can be designed to target the genetic makeup of viruses, bacteria and cancer cells. Its advantage can be a time when medications are accurate in targeting specific diseases at the least adverse drug reactions. If the new science of combined pharmacology and genomics will be harnessed, it will remarkably improve the formulation of medicines.
However, pharmacogenomics is still at its infancy after more than a decade of conducting scientific investigation. Despite its promises in disease and medicines and health and aging, it faces several issues. Some of them are listed as follow:
1. Fear in reduction in revenues. Pharmacogenetics will revolutionize the way clinical trials are conducted. Researchers can remove from their trials participants whose genetic makeup will make their body respond badly or dangerously on a certain medicine, and hence target only those whose genetic makeup will have a positive response.
Based on this premise, there is fear being stirred that the science will segment markets and dramatically decrease revenues. Given that pharmaceutical companies spend a fortune in developing new drugs, many have questioned their willingness to invest in the Research and Development process despite the knowledge that the medicines to be produced will only be applicable to a very small portion of the population.
Those who are favorable to the utilization of pharmacogenomics reason out that the Research and Development process will be conducted with more efficiency and lesser cost, and thus, compensates for the reduced patient population. Moreover, there has already been a success in the field of using genetic approach to drug development. Evidence to this is the drugs Glivec and Herceptin in treating cancer, which have been well-received by patients. Cancer is the area in pharmacology in which pharmacogenomics will have its initial impact.
2. Pharmaceutical companies are confused on which regulatory agencies are seeking what as far as pharmacogenetic information of their products is concerned. However, the US Food and Drug Administration recognized the potential of the study in drug discovery and treatment. Thus, it acts as the regulatory leader and develops detailed guidance document providing information on its current disposition and the use of pharmacogenetic for regulatory decision-making.
In addition, the FDA introduced genomics training programme for its staff. It issued guidance documents to encourage the voluntary submission of genomic data by organizations to the agencies.
3. Complexity in finding gene differences that influence drug response. The SNP or single nucleotide polymorphism is the DNA sequence variation that exists when a single nucleotide-whether A, T, C, or G-in the genome sequence is modified. The emergence of SNPs happens every 100 to 300 bases along the 3-billion-base human genome. Thus, millions of SNPs should be identified and analyzed to determine their participation in drug response.
Further, knowledge of which genes are involved in each drug response is limited. Therefore, getting the big picture on the impact of gene variations is time-consuming and complicated given the fact that many genes influence responses.
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