Most people enjoy being the center of attention in various circumstances. In medicine, seemingly the patient is the center of attention each time a consultation takes place, but when considering the personalized medicine approach, the usual practices lose their supreme individual–focused status.
Also known as precision or stratified medicine, this medical model segments the patients group into small groups or even considers each patient individually based on each person’s genetic content or other molecular or cellular analysis. The human genome variation specific to each person determine variations in symptoms and medication responsiveness.
Starting with genome analysis, a personal healthcare plan predicts the likelihood of diseases, establishes a more accurate cause-effect relationship and tailors better treatments for the patient. Tailoring drugs and treatments on the individual’s specific profile has proved more efficient and beneficial compared to the generic approach.
Personalized medicine challenges
The economic challenge
Performance needs investment – here’s a rule that does not contradict itself when it comes to personalized medicine. This approach is more expensive, from human genome sequencing processes to the specific drugs – often made from biologic material.
The involved costs raise insurance companies’ concerns. They will ultimately affect patients, which will have to supplement the fees with their out-of–pocket money. It has been established some time ago that the biggest specific challenges are not scientific, but economic. Although the higher investments are set to produce “substantial savings” in the long run, there is still the issue of who should cover the immediate costs. A 10 to 15 years estimate is needed for the full picture to unravel, while showing how personalized medicine is actually more cost-efficient in the long run doesn’t do much for those who have to pay the higher up-front costs now.
Another cost-related dilemma concerns the medication involved in personalized medicine – since the target groups are smaller, the drug producers will compensate with increased prices. The sick patients may have to face such high medication prices that treatment could prove economically unbearable.
The private data challenge
Healthcare data is already a hot target for cyber-criminals. Once it includes detailed genome data and precious information on how certain diseases are linked to particular gene sequences or derive from specific mutations, the value of the data will increase exponentially. Such medical details would present an increased risk of being hacked and stolen, so any flaw in the digitized data storage and handling system would have to be patched rigorously.
Potential dilemmas
- In an exercise of imagination, let’s say a doctor working with the personalized medicine method established a pattern that could explain a certain affection or disease – what would be the confidentiality regulations? Since exposing the genome data comes right at the beginning of such procedures, as a mandatory prerequisite, the patients have obviously agreed to share their genetic data in order to receive diagnosis and treatment. However, what happens when their data is essential to support medical breakthroughs? Will the initial agreement cover this scenario? Should the patient sign a following different agreement (the most logical case)? What if the patient desires to keep his data out of the scientific process – and the doctor faces the temptation of following through his discovery?
- Genetic manipulation in already on the brink of disrupting the medical process, as we know it. Will people’s decisions change when they will be based upon genome information? Forming a couple or deciding to have children may be heavily determined by such considerations, to an extent hard to imagine nowadays by most of the people.
- The medical “marvels” challenge translates as these situations where a patient makes an amazing recovery despite all the scientific and logical factors is not a stranger to medicine. Without going further into details, such miraculous healing examples illustrate the human mind over body power.
Would such situations be encouraged or dismissed by personalized medicine? Alternatively, will putting someone’s genome into the entire equation help explaining why certain people are able to overcome health challenges better than others?
The fight for personalized medicine
The Personalized Medicine Coalition promotes public policies that favor personalized medicine and invest in this medical model. Representing innovators, scientists, patients, providers and payers, this entity supports targeted treatment and prevention plans based on physicians applying their precision medicine findings.
Integrating personalized medicine into mainstream policies is an ongoing mission for PMC, which organizes and takes part into various specialty events.
Their paper entitled “The Case for Personalized Medicine”, edited in 2014, offers an explanatory overview of what the personalized/precision/stratified approach means and its benefits. The Human Genome Project (HGP) costs are included in this material, as well as a brief history of accumulated data that forms the foundation for health care advancements, starting with Sir Archibald Garrod 1902 connection between genetic inheritance and susceptibility to a particular affection or disease.
Interesting in-depth data is presented in this paper realized by the PMC in collaboration with the University of Florida PMC student chapter (Ph.D. Stephan Schmidt as guiding professor – in what the Selected Personalized Medicine Test and Drugs updates are concerned.
January 2015 marked the announcement made by US President Barak Obama on the US$215-million National Precision Medicine Initiative. A national one million people genetic database and N-of-1 trials (studies focusing one individuals) are to be installed via this initiative, whose infrastructure that welcomes participants is still to be completed.
While government agencies slowly but steadily move forward with the precision medicine programs and introductory initiatives, another point of view skeptically takes into consideration the Faustian character of this medical approach. An impoverished society determines individuals to sell short: selling their abilities, their data, their services may take a very dark turn once genetic material will be mass-purchased by pharmaceutics companies trying to tailor their drugs on population groups. How much ethics might be affected and what will happen once medicine fails to even try to be democratic – these questions are worth considering.
Is the stratification of medical services already present, but society somehow doesn’t face it because it is not prepared for this reality, or is there still a chance for a balanced and relatively harmonious medical system that targets all citizens and strives to keep the ethics as a core of its endeavors? Only the future will tell.
