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02/18/2015

Precision Medicine Has Imprecise Ethics

by Craig Klugman, Ph.D.

How do physicians diagnose disease? First they go through a set of symptoms and then compile a list of differential diagnoses or what the underlying disease may be. Then the doctor performs tests to rule out some diagnoses and advance others. In essence, though, diseases are classified according to their affect on the body—their symptology. What if instead of by symptoms, diseases were classified by their molecular function? Instead of being diagnosed with Type II Diabetes one might be diagnosed by whether there is a death of beta cells (i.e. production of insulin) or if the receptors do not work and cannot bind with insulin proteins (i.e. insulin resistance). This change in disease classification is part of an initiative known as “precision medicine.”

In his State of the Union Address, President Barack Obama outlined his $215 million “Precision Medicine” initiative. The idea is to use knowledge of genetics, health threats, and individual responses. For example, some people with Type II Diabetes may lose a limb and others may not. Would an examination of their DNA give a clue that would permit the development of a predictive test as to who is at risk for limg problems? People with the same disease often have it affect them in widely different ways. Precision medicine hopes to use techniques of big data and DNA analysis to discover whom and why.

This notion comes out of a 2011 Institute of Medicine Report: Toward Precision Medicine: Building A Knowledge Network for Biomedical Research and A New Taxonomy of Disease. The theory is that by understanding disease on a molecular and cellular level, rather than just on the symptom level, preventive drugs and treatments could be tailored to the individual. The report recommends building translational science, evolving a new taxonomy of disease, developing data sharing databases that are faster and cheaper than current efforts, conducting research, and encouraging public-private partnerships to improve health outcomes.

This report forms the foundation of President Obama’s proposed initiative. By using human genome sequencing technology, biomedical analysis tools, and the power of big data, a new era of precise medicine will be fostered. The short-term goals for the project are drug trials for targeted cancer treatments. In the long term, the hope is to (1) create a network of scientists to work on these questions and (2) create a cohort study of over a million people. Individuals in the study will give both genomic and tissue samples, clinical heath data, laboratory and scanning tests, and lifestyle monitoring (such as calorie consumption and expenditure, environmental exposures, sleep—think of researchers mining all of the data from your FitBit).

This effort should lead to new target drugs, new treatments and prevention, and integrating cell phones into our daily health (and unhealthy) routines. Theoretically, one will know how a disease will affect her or him, which drugs offer the best treatment, and an individualized mobile guide to manage the condition on a day-to-day basis.

This approach presumes that disease is mainly managed and directed by genetics—it nearly eliminates the notion of environmental factors as causal factors of disease. It also assumes that health and disease can easily be mapped to genes. Given that many diseases are related to a number of genes, finding precise answers may be fairly difficult for many conditions.

This project raises issues of health equity. Will precision medicine increase or decrease health disparities? Will a high-tech personalized approach only be available to those with means or platinum/Cadillac insurance plans? Will having a certain genetic subtype of a disease increase or decrease stigmatization of the disease?

From a bioethics standpoint, there may be great opportunities here. The Human Genome Project provided funding that created the subfield of genetic ethics (or genethics). The NIH BRAIN program has led to research and funding opportunities in neuroethics. Might Precision Medicine lead to a “precision bioethics” where we can help you make decisions based on your own genetic make up? The notion that this will be a boon for bioethics can be seen on the White House’s own webpage about the project: “commitment to protecting privacy…solicit[ing] input from patient groups, bioethicists, privacy, and civil liberties advocates, technologists, and other experts in order to identify and address and legal and technical issues related to the privacy and security of data in the context of precision medicine.”

Privacy is the main bioethical issue raised by the framers of this initiative. Given the record of companies and institutions with maintaining online privacy, I’m not sure we should yet be confident that privacy could be assured. And then consider that health information will be collected via mobile devices and transmitted wirelessly presenting additional opportunities for privacy breaches.

This could be the beginning of a new subfield of bioethics or just an overpriced promise that comes to nothing. While the name may be precise, the science and the ethics are anything but.

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