Personalized medicine: an introduction, its promises and the ethics

Personalized medicine is such a prevalent and important topic within the biotech and healthcare industries, that it merits its own post.   It has been identified as one of the top drivers of biotech innovation by Ernst & Young, and promises to usher in much needed cheaper and safer healthcare.  Unsurprisingly, BIO hosted an entire track on biomarkers, a component of personalized medicine, and many other sessions on the topic throughout its 2008 convention.

Personalized medicine is a young but rapidly advancing trend in healthcare.  It took off after the first sequencing of the human genome, performed by Craig Venter in 2003.  Incidentally, Craig Venter gave an interesting keynote speech during lunch this week.

Personalized medicine analyzes a person’s molecular information to determine the person’s propensity for developing certain diseases, including a disease’s potential onset and course.  It also determines a person’s propensity for responding to different drug therapies, by determining a patient’s ability to metabolize drugs and/or likelihood of experiencing adverse drug reactions.  The term personalized medicine is often used in place of the scientific term pharmacogenomics.

Personalized medicine promises two crucial triumphs, namely the delivery of cheaper and safer healthcare, as highlighted at the BIO convention session entitled “Building on Success”.  The two triumphs are discussed further below, followed by the changes needed to enable the triumphs and lastly some relevant ethical concerns are identified.

The first triumph, delivering safer medicine, results from personalized medicine’s promise to reduce overall adverse drug reactions (ADR) and to identify ideal drug dosing for individual patients.  Personalized medicine proactively identifies patients likely to experience ADR and determines the proper dosages needed for each patient by highlighting the person’s ability to metabolize a drug.  Although some adverse drug reactions are not very serious, others cause the death, hospitalization, or serious injury of more than 2 million people in the United States each year, according to the FDA.  In fact, adverse drug reactions are one of the leading causes of death in the United States. [1]

Personalized medicine also promises to reduce healthcare costs by identifying the most effective treatment for individual patients, thereby eliminating the cost of unnecessary treatments, and by speeding up clinical trials.  BIO’s panelist Mara Aspinall, past president of Genzyme Genetics, states that, “when a cancer drug works, you get positive results within weeks or months, not years.  But it takes much longer to prove a negative response.  By removing from the trial those who are unlikely to respond, you also shorten the length of your trial.” [2]

Senator and presidential candidate Barack Obama (D-IL), introduced a bill entitled the “Genomics and Personalized Medicine Act of 2006” (S.3822), “to secure the promise of personalized medicine for all Americans.”  However, further action is needed to secure personalized medicine for all Americans. 

For example, because personalized medicine relies on the collaboration of drug and device companies, new standards will be needed for the approval and reimbursement process of the newly created drug-device combinations.

Interestingly, a change in the way we calculate cost-savings may also be necessary for the value of personalized medicine to be recognized.  Currently many governments measure cost savings in specific budget cycles and in specific categories, rather than over time and/or on a system-wide basis.  BIO’s panelist Geert Nygaard, CEO of Epigenomics AG, states that:

“government run healthcare systems in many countries … are measured on their ability to keep costs under control in a specific budget cycle, but the economic benefit from preventative tests may only occur over five to ten years….( also) if they have a certain budget for the diagnostic bucket, they are unwilling to spend any more than that on diagnostics.  They don’t look at the benefit to the entire healthcare system and the savings that diagnostics may be generating across the system.”

There are many more necessary considerations to enable the flourishing of personalized medicine, but the scope of this post does not support a detailed analysis of each of them.  However, as a bioethicist, I would draw attention to some the ethical issues in need of attention in order to proceed in the most beneficial manner for patients and society, many of which already exist in the rich history of healthcare:  (1) just access to, allocation and application of the new technologies, (2) privacy concerns, (3) respecting parties’ autonomy, (4) obtaining quality informed consents, (5) intellectual property rights, particularly in connection with bio-banking, (6) overall resource allocation and prioritization questions, and many more. 

It looks like the PMC, personalized medicine coalition, will or is broaching some of the ethical inquiries in collaboration with biotech and device companies.  I will be contacting them to learn more.  It will be interesting to see how the field develops. 

I cannot wait for next year’s BIO convention to experience firsthand the new innovations and trends in biotech and to see how our future in healthcare, agriculture and energy continues to progress.

By:  Jennifer Miller (c) 2008 Bioethics International, New York 2008

  1. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. Journal of the American Medical Association Apr 15, 1998; 279: 1200 – 1205.
  2. Perspective on personalized medicine, An Ernst & Young Roundtable, 2008 Global Biotechnology Report

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