Comments

Health Affairs encourages readers to engage in discussion via comments on our Web site.

• To RESPOND to a particular article: Click on the link "Submit a response to this article" in the box at the top right-hand corner of the article.
• To READ responses to a particular article: Click on the link "View responses" in the box at the top right-hand corner of the article.

Comments to:

Peter J. Neumann Emerging Lessons From The Drug Effectiveness Review Project Health Affairs, July/August 2006; 25(4): w262-w271. [Abstract] [Full Text] [PDF] [Reprints & Permissions]

Comments:Submit a response to this article

Comments published:

DERP Compared to What?

Ramon Castellblanch   ( 9 June 2006 )

Balancing Individual Needs With Scientific Evidence

Jennifer L. Bright   ( 1 August 2006 )

DERP Compared to What? 9 June 2006
Ramon Castellblanch, Assoc. Prof. San Francisco State University Send comment to journal: Re: DERP Compared to What? ramonc{at}sfsu.edu Ramon Castellblanch	What's interesting about your DERP article is that you don't appear to compare DERP to anything else. The science of comparing the safety and effectiveness of medicines may be evolving; but what about the main source of information on drug safety: pharmaceutical industry advertising? Compare how DERP and pharmaceutical advertising handled Vioxx, a drug Lancet estimates caused 88,000 heart attacks, 38,000 resulting in deaths. Merck promoted it until they had to take it off the market - leading to this staggering toll. DERP recognized its dangers well before then, published the information, and Medicaid programs using its research took it off their formularies - saving lives. Compared to the main source of information on drug safety, DERP appears quite superior.
Balancing Individual Needs With Scientific Evidence 1 August 2006
Jennifer L. Bright, Vice President, State Policy and Convener, National Working Group on Evidence-Based Healthcare National Mental Health Association Send comment to journal: Re: Balancing Individual Needs With Scientific Evidence jbright{at}nmha.org Jennifer L. Bright	The June 6, 2006, Web Exclusive series on the Drug Effectiveness Review Project (DERP) provides an informative discussion of the project from important viewpoints. We strongly support using the best available scientific evidence in balance with individual needs. It was therefore disappointing not to see a robust discussion of individual consumers’ role in evidence-based health care. Moreover, issues of population versus individual applications of evidence-based medicine, accountability in generating evidence used by policymakers, and accurate communication of evidence gaps and uncertainties demand further examination. First, the translation of clinical effectiveness research into policy rarely discusses the balance between the general population and individual consumer perspectives. Narrowly focused evidence reviews such as DERP often exclude studies that are not randomized controlled trials (RCTs), omitting research that is more reflective of the “real world.” Although RCTs are considered the gold standard of evidence, problems of external validity limit their usefulness in answering value-based policy questions. As a contrast to DERP, the Blue Cross and Blue Shield technology assessment program considers a wide array of evidence that includes observational studies, disease registry data, and expert opinions drawn from clinical guidelines. Second, private organizations giving policymakers information for decision making need to be publicly accountable, especially when public funds are at stake. Well-publicized opportunities for public comment and clearly defined rules for considering those comments help ensure broad participation and reinforce transparency and accountability. DERP does not generate a summary of changes incorporated from draft to final reviews or provide a rationale for acceptance or rejection. In contrast, the national coverage determinations of the Centers for Medicare and Medicaid Services (CMS) include explicit discussions of public comments that the agency receives in response to draft policies. Third, when uncertainty of a technology’s effectiveness or gaps in clinical evidence exist, consideration of the impact on policy decision making must occur. A lack of evidence does not mean that there is no difference between medical treatments or technologies. DERP reviews state when a lack of evidence exists, but then leave policymakers to assume that all treatments are equal for all individuals. In contrast, guidances from the U.K. National Institute for Health and Clinical Excellence (NICE) include “future research recommendations” when evidence is insufficient. One reason this is important is the dearth of research focused on response differences by people of different genders, races, and ethnicities. Drawing short-term conclusions based on emerging evidence may have the unintended consequence of exacerbating health care disparities. Policy developments applying comparative effectiveness research in decision making often lack inclusion of the individual patient perspective, and can lead to serious consequences. For example, an individual on anti-convulsant drugs forced to switch to another drug (generic or brand name) because of policies derived from research such as DERP generates may experience avoidable breakthrough seizures. Such unintended consequences have both cost and quality-of-life considerations that must be balanced with the important knowledge that current science conveys.