There are many reasons to be optimistic about pharmacogenomics and personalized medicine. Put simply, pharmacogenomics makes it possible to factor a patient’s genetic information into the treatment process so that clinicians are less reliant on a trial-and-error approach to prescribing medications. But there are also several challenges that researchers will need to overcome.
While are starting to change the face of medicine, it is not without its challenges. The first is the abundance of data. While more and more is known about drug-gene pairings, there is also an endless number of variations to explore. In oncology, the complexity is compounded by the fact that each patient’s cancer has and continues to undergo a unique mix of genetic changes. These complexities make it difficult to truly find the right drug for the right patient in all contexts. Indeed, a wide-reaching report from the Nuffield Council has suggested that the notion of applying pharmacogenomics to find the right drug for the right patient is overly optimistic. The potential for pharmacogenomics should rather be characterized as a particular drug for patients with certain genetic characteristics.
Pharmacogenomics also faces a series of ethical challenges—from data usage and privacy to inequities in terms of product development to potential cost challenges for certain groups of patients.
Price manipulation or more restricted product supply have been posed as potential consequences of pharmacogenomics. A pharmaceutical company may choose to focus only on patients with easy-to-treat variations of a condition or price drugs higher for smaller segments of a therapeutic market. On the other hand, pharmacogenomics has the potential to reduce risk and cost in clinical trials by ensuring only the right patients are enrolled, which likely would allow companies to bring drugs to market more rapidly. In addition, drugs that were dropped due to safety or efficacy issues in clinical trials could be revived and targeted to smaller sub-groups.
Concerns have also been raised that the potential cost of pharmacogenomic drug development may lead to genetically-based treatments being . However, analysis suggests the development of pharmacogenomic technologies will likely result in the development of drugs for at-risk populations.
One of the most controversial issues around pharmacogenomics is the development of what has been dubbed “ethnic drugs.” The drug BiDiL has been marketed as a treatment for African Americans with heart failure. But research indicates that genetic differences between ethnic groups is a poor determinant of genetic make-up with drug-gene variations.
Perhaps the most pressing concern relates to data usage and privacy. Since the Cambridge Analytica scandal, in which personal data was harvested and used to target individuals with personalized political advertisements, how a person’s data is used has become a major source of concern. Questions have been raised about who controls the data as well as the possibility that a person could be identified in some instances. A recent BMJ report also raised concerns about the collection and storage of DNA samples during clinical trials particularly with regards to “consent and confidentiality, ownership, access, and control of such data.”
Issues have been raised about how genetic data can be used by law-enforcement officials after police used data from GEDMatch, a genealogy website, to solve several murders and rapes, including most famously identifying the Golden State killer. After one teenager was arrested on suspicion of assault, the website shut off access to police, creating frustration for police and genetic genealogists who have used the data to solve old murder cases.
A brave new world
Despite the challenges, breakthroughs in gene-drug interactions and growing insight into genetics suggests pharmacogenomics will transform patient care by allowing for more patient-specific treatment. This approach can in turn reduce costs to healthcare systems and empower clinicians to prescribe to their patients with greater authority. Read more about advances in genomics in Part 1 of our series.