Is personalized medicine viable?
written by Lucky Group 13
Introduction
Personalized drug therapy is being billed as the new era of pharmaceutics. Clinical pharmacogenetics allow clinicians and pharmacists to identify the safest and most effective drug and dosage for each patient. They can do this by studying the individual genetic polymorphisms that will affect the patient’s drug response and therefore the efficacy and toxicity of the administered drug. Ideally, this will prevent adverse effects and promote optimal dosing of drugs based on the patient’s genetic profile. In reality, there are many different issues surrounding the implementation and viability of personalized medicine, and these have limited its use in the current health care system.
Privacy Issues
In order to efficiently implement pharmacogenetics as a personal medicine service, there needs to be a method of collecting and storing people’s genomic and genetic information efficiently and accurately. Genome mapping of individuals may be something that can be done during the already recommended pre-screening tests, or following the quick blood test that they are already preforming post-birth. These records can become an addition to an individual’s medical records, just as weight, height, and drug allergies are commonly seen. They can be safely and confidentially stored as any medical records, and used only with patient consent or by the patient’s health care team. When viewing collection of genetic information to be like this, there exist no additional privacy concerns aside from existing ones with conventional medical records.
However, genetic information of an individual may be considered a more sensitive private information. We understand that genomic information can be extremely useful in tailoring medical therapy and improving patient health care, but it can also be a means to discrimination. Discrimination against a patient’s predisposition to certain diseases or ailments when it comes to providing health insurance, employment, relationships, etc; anything! This type of discrimination is a realistic threat, as there are laws that were made to protect individuals from the discrimination that can come from their genomes, e.g. Genetic Information Nondiscrimination Act, and Health Insurance Portability and Accountability Act. However, we need to remember that a person’s actual outcome (phenotype) would not only be based on the genotype – the DNA characteristics – but also on the environment.
For personalized medication to be viable, we would have to make sure the public understands the concept, as well as participants are aware they are entering under full consent, so to lower the amount of privacy issues.
Public opinion
Before pharmacogenomics can be implemented as the new gold standard of pharmaceutical care, it must convince not the practitioners or legislators of its merits, but the public at large. One only needs to go as far as topics like stem cell treatments and abortion guidelines to see the power public opinion holds over the development and implementation of health care practices, and pharmacogenomics without a doubt will experience similar controversy.Implementation of pharmacogenomics on a large scale involves sequencing a patient’s genome as part of building the patient profile, and using that information to to tailor drug therapy and minimize side effects. Genomics intrudes upon the topic of human genetic engineering with the concept of sequencing a patients genome to personalize treatments such as gene therapy. The foundation of the concept is identifying human genetic deficiencies and compensating by introducing foreign genetic material. It is not too difficult to envision the transition from compensating to improving. This raises the question of whether or not the sequencing of genomes should be restricted to patients with hereditary diseases. If genome mapping is not regulated and made accessible to all, will there be a future where patients undergo unnecessary gene therapy to boost the activity of an enzyme functioning at reduced capacity they naturally have?This is just one situation. Another controversial topic can be whether or not sequencing should be allowed before birth: the comparatively simple idea of determining the gender of a fetus is already a hotly debated topic where the ethical concern lies with the issue of selective abortions. Health care is a multidisciplinary field and the developments in one practice can have far reaching consequences on other disciplines. Pharmacogenomics faces a daunting challenge as its core concept of genome mapping presents so many opportunities, and just as many controversies
Cost-Benefit Considerations
As with any new technology and ideas, cost is a major concern that comes to one’s mind. How much is it going to cost to implement this new health care service? What about the training process involved for health care professionals to be able to offer this service? Are patients going to be able to afford it? Who is going to fund this service? Is it going to be covered by PharmaCare or Medicare? Looking past the cost of personalized medicine, there are clear benefits to it with the obvious being improved health care outcomes and increased quality of care for patients. The bottom-line is that one needs to carefully consider the costs and benefits of personalized medicine before a decision is made to accept or reject this service.
Accessibility & Practicality
We have talked about how personalized medicine will allow health care practitioners to provide almost perfect therapy, with treatment as individualized as the patient, but should we make this accessible to everyone? Currently, to a certain extent, personalized medication is utilized in certain cancers and autoimmune disease but how practical it would be in treating common illnesses such as hypertension or depression is still quite vague. Therefore, is it really necessary to make it more publicly accessible than it is now? Is the cost, labour, and resources that are required to map a genome for a single person worth it, just to prevent someone from getting nausea from their narcotics? We can always restrict the access to designated patients who meet certain criteria, but to whom? Even with the lack of labour and resources that are required to implement personalized medication currently, there are lots of issues that needs to be clarified and set before this can be made accessible to the general population.
Change can be difficult
The profession of pharmacy, one could argue, has evolved slowly over the past few decades, as evidenced by pharmacists still underappreciated or negatively portrayed as overpaid pill counters. Current pharmacists may not be comfortable with breaking the status quo (and maybe the general public do not want to see this status quo broken either). It can be difficult to step outside our comfort zone to embrace new technologies and services such as personalized medicine, especially if they were never trained or educated in these areas when they were in school. Pharmacies may need to invest in new technology and staff training and education, neither which will come free of charge. Pharmacies and pharmacists will want to see a return on their investments. The current business model might not be ideal, but let’s hope the Blueprint for Pharmacy paves the way for personalized medicine.
Since we are striving for “patient-centered” care, the idea of personalized medicine must also be embraced by the general public, or it may never take off to the extent to which it is hoped.
It may take a while to educate the average Joe on health issues and dispel myths in general, let alone explain what personalized medicine is and how it may benefit them. Just ask the anti-vaccine camp who still doubts the benefits of vaccinations and herd immunity and/or views vaccines as a form of government control or cause of autism.
It will take quite some time before the science of personalized medicine matures and the knowledge base of human genetics is sufficient to be utilized in drug research and therapy for a broad range of disease states.
And It may take many more years before personalized medicine becomes mainstream and widely adopted by both the general public and health care professionals for whatever reason, be it indifference, reluctance, skepticism, fear, or money.
Bottom Line/Conclusion
There are lots to be done in the process of working towards a world of personalized medicine. Genome mapping would allow us to provide a new level of personalized care to each patient and could greatly benefit some individuals, however it may be unnecessary and overly expensive to be provided to everyone as the average member of our population may see no benefit. Pharmacogenomics also presents us with a wealth of new ethical issues that we would need to learn how to deal with regarding patients privacy and right to confidentiality, as well as potential discrimination and use of the technology for the wrong reasons. It would be an expensive and slow transition and implementing the accessibility for all patients is questionable. In order to continue down this path towards personalized medicine for all, more research is required and we will need to come up with concrete methods to protect our patients and their privacy.