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Science, Policy, and Ethics in Personalized Medicine

What are the Policy Issues in Personalized Medicine? | Main | What is Pharmacogenomics?

What are the Ethical Issues in Personalized Medicine?

I've discussed some of the scientific and policy challenges that surround personalized medicine, but I've left for last a much harder task: defining the ethical issues. From my perspective, policy and science problems share at least one important common feature - even if no one can agree on the optimal solution, it's possible to propose a solution, consider it's appropriateness in a reasonably objective fashion (hopefully using some pre-determined metric), and make adjustments based on its performance. Ethical issues are a bit trickier. I would guess that most people are willing to agree on what (most) the issues are, but that's about as far as things go. Trying to decide on appropriate solutions is much harder, because it's essentially a balancing act, and success looks less like an objective criteria and more like alienating the fewest people possible.

Becuase these issues are so much more difficult, I'm going to limit myself to three different classes of issues:

  1. Protecting patient privacy
  2. Protecting patient autonomy
  3. Allowing access to personalized medicine

Protecting patient privacy is one of the most important things that must be done before ordinary people will be willing to take advantage of individualized medical care, and just about everyone agrees that patient's have a right to keep details about their health private from most people (even if not from, say, their insurance company or in some cases state or local governments). But how far does that right extend? Does it cover a person's genetic makeup? That is something that undeniably influences health, and a fair amount of information about what diseases a person has or is at risk for can be extracted from genotype and gene expression information like what would be collected for personalized medicine services. How do you keep that information private and what uses are OK? For example, if a person has this information collected for use in risk profiling or diagnosis, should that then automatically commit them to allowing their data to be used for diagnosing and profiling others? While this can be done without identifiers, this information is, in effect, personally identifying, so it can never be truly anonymous. Additionally, what about the privacy of other family members? Families share genetic information, and by knowing something about their risk, a person also learns about their relatives' risks.

One of the issues of privacy is also directly related to patient autonomy - the right of a patient to choose what happens to them. The question of what uses of a patient's data are permissible is not exclusively a question of privacy but also one of autonomy. Is it OK to require a person to allow their data to be used for risk profiling or diagnosis as a condition of performing the service for them? The reasons for doing this are compelling (because large sample sizes are necessary for high quality risk prediction), but is it undue pressure on person to require it? That is to say, if agreeing to this is a condition, can that agreement really be considered free and consensual? What if the condition was not to allow the data to be used for diagnostic work but for research? Should a company be allowed to offer to collect this data for free in exchange for allowing its use in pharmaceutical development or trials? It's a long established concept in research that the incentives offered for participating in trials and research studies should not be so high as to . High-throughput data collection will likely be fairly expensive even for those with insurance (and probably nearly unattainable for those without insurance), what level of incentive is overly tempting? Another privacy issue is also an autonomy issue: if a relative learning something about their risk of a disease says something about your risk of a disease, should you have to consent before that relative can have those tests performed? How can we deal with this information being effectively forced on people?

Cost, just like with the policy issues last time, is a significant ethical issue as well. Something like 46 million people are without health insurance today, and many more have insurance plans that cover only the most basic things. How can we provide access to personalized medicine to everyone? Is access for everyone a reasonable goal? Is it an attainable one? These are some of the toughest questions that have to be answered, but luckily they're very similar to questions that have already been asked about traditional health care. There will likely be a number of levels of personalized care, and if universal access is a goal, what level is acceptable? Is a tiered system where those who can't afford to pay on their own receive some level of service while those who can afford it get more comprehensive care ethically sound? It's something that looks much like our current health care system, but many people are unhappy with that model.

Although the ethical issues facing personalized medicine are tricky, they're actually not that much different than the ones that face traditional medicine. This means that the research and dialogue about them can be transferred, so the conversation doesn't have to start from scratch. It's back to science next time, with a more in depth look at pharmacogenomics.

reagank | 12:28 PM 03/16/2007 | background , ethics , problems

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Reagan Kelly is a PhD student at University of Michigan studying bioinformatics. His thesis is focused on risk prediction algorithms for personalized medicine systems, and he is also interested in the policy and societal implications of individualized healthcare.You can read his CV for more information about him. If you would like to contact him, please send an email to reagank -at- reagank.com

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