Letter from the Executive Director.

Abstract

Personalized MedicineVol. 6, No. 5 News & ViewsFree AccessLetter from the Executive DirectorEdward AbrahamsEdward Abrahams1225 New York Avenue, NW, Suite 450, Washington, DC 20005, USA. Search for more papers by this authorEmail the corresponding author at eabrahams@personalizedmedicinecoalition.orgPublished Online:18 Sep 2009https://doi.org/10.2217/pme.09.38AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail As the US Congress debates healthcare reform this summer, the Personalized Medicine Coalition (Washington DC, USA) has underlined its support for a key element of reform that would incorporate personalized medicine principles in judging the effectiveness of a drug or treatment. The larger global context for this debate regarding ‘comparative effectiveness’ is the fiscal imperative to control costs while not limiting access to clinical care or discouraging innovation. We contend that personalized medicine can help address the conundrum.On 24 June, 2009, the Personalized Medicine Coalition sent a letter to Senate Finance Committee chairman Max Baucus of Montana (USA) and Senate Budget Committee chairman Kent Conrad of North Dakota (USA) indicating our support for the leadership that the Senators have shown in their efforts to ensure that comparative effectiveness studies conducted in the USA determine not only what treatment works best, but also for whom.That letter follows:June 24, 2009The Honorable Max BaucusCommittee on Finance219 Dirksen Senate Office Bldg.United States SenateWashington, DC 20510, USAThe Honorable Kent ConradCommittee on Budget624 Dirksen Senate Office BldgUnited States SenateWashington, DC 20510, USADear Mr Chairman and Senator Conrad:Thank you for incorporating language supporting the principles of personalized medicine in the Patient-Centered Outcomes Research Act of 2009. The additions will advance science, improve the quality of clinical care, and also reduce the overall cost of healthcare by enabling physicians and patients to select optimal therapies based on molecular profiles and other differences.The bill’s proposed language also will avoid locking medicine into a one-size-fits-all paradigm that could be an unintended consequence of poorly designed comparative effectiveness research studies. Such studies are likely to rely on population-based averages instead of a more sophisticated understanding of individual variation. Well-designed comparative effectiveness studies, such as those promoted by this bill, can determine not only what works best, but also what works best for whom. Indeed, we are concerned that other comparative effectiveness legislation threatens to codify one-size-fits-all medicine.As you know, personalized medicine, according to the President’s Council of Advisors on Science and Technology, means ‘tailoring medical treatment to the individual characteristics of each patient by classifying individuals into subpopulations that differ in their susceptibility to a particular disease or their response to a specific treatment’. Done right, comparative effectiveness research can help realize the goals of healthcare reform by getting the right therapy to the right patient, the first time.It is clear that the Patient-Centered Outcomes Research Act will:▪ Incorporate research on patient preferences in the scope of work, including quality of life, physician and patient choice;▪ Expand the research agenda to include primary research on molecularly-informed trials;▪ Define potential differences to include genetic and molecular subtyping;▪ Add experts in molecular diagnostics to the methods panel;▪ Instruct the methods committee to determine how to incorporate new information and technological innovations into comparative effectiveness research, as well as review and update evidence as necessary;▪ Incorporate research on benefit design and information communication;▪ Include quality of life in the definition of value in the methods section.Comparative effectiveness research that helps improve our understanding of differences in patient response can do more to improve the quality of health outcomes and contain costs than any other policy recommendation under consideration. Comparative effectiveness research conducted under the auspices of the Federal Government must account for factors contributing to variation in patient responses to treatment, as well as the preferences of patients taking advantage of the latest advances in science and technology. If it does not, the research will neither improve quality nor decrease costs.The Personalized Medicine Coalition believes that the Patient-Centered Outcomes Research Act of 2009 achieves the goals outlined above, and therefore supports passage of the bill, as long as these principles of personalized medicine are part of the final package. We look forward to working with you in support of S. 1213 to advance personalized, evidence-based medicine as part of healthcare reform.The Personalized Medicine Coalition is an education and advocacy organization that promotes personalized medicine concepts and products for the benefit of patients. Our members include patient, payer, provider, industrial and academic organizations that are committed to improving the quality of healthcare through personalized medicine.Sincerely yours,Edward Abrahams, Executive Director,Personalized Medicine CoalitionFiguresReferencesRelatedDetailsCited ByChallenges in pharmacogenetics3 May 2013 | European Journal of Clinical Pharmacology, Vol. 69, No. S1Safe and effective medicines for all: is personalized medicine the answer?10 January 2014 | Expert Review of Clinical Pharmacology, Vol. 3, No. 5 Vol. 6, No. 5 Follow us on social media for the latest updates Metrics History Published online 18 September 2009 Published in print September 2009 Information© Future Medicine LtdPDF download