Translating epoetin research into practice: The role of government and the use of scientific evidence

Health Affairs

Volumn 25, Issue 5, 2006, Pages 1249-1259

  Cotter, Dennis ^a   Thamer, Mae ^a   Narasimhan, Krishnan ^b   Zhang, Yi ^c   Bullock, Kim ^b  

^a Medical Technology and Practice Patterns Institute Inc (MTPPI)   (United States)

^b GEORGETOWN UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c MTPPI ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIANEMIC AGENT; ERYTHROPOIETIN;

DECISION MAKING; DRUG APPROVAL; ECONOMICS; FOOD AND DRUG ADMINISTRATION; HEALTH INSURANCE; HUMAN; MEDICARE; PRACTICE GUIDELINE; REVIEW; RISK ASSESSMENT; UNITED STATES;

DECISION MAKING; DRUG APPROVAL; ERYTHROPOIETIN; HEMATINICS; HUMANS; INSURANCE, PHARMACEUTICAL SERVICES; MEDICARE; PRACTICE GUIDELINES; PRACTICE GUIDELINES AS TOPIC; RISK ASSESSMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 33749329565     PISSN: 02782715     EISSN: 02782715     Source Type: Journal    
DOI: 10.1377/hlthaff.25.5.1249     Document Type: Review

References (43)

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5. M. Goozner, "The Making and Selling of a Star Drug," Chicago Tribune, 24 May 1999.
6. The FDA-approved epoetin label states that the maximum amount of epoetin that can be safely administered has not been determined.
7. Certain types of providers dominate the dialysis market; between 1995 and 2005, the market share of free-standing and for-profit facilities increased from 74 percent to 86 percent, and from 65 percent to 78 percent, respectively. In 2005, 60 percent of all dialysis facilities were affiliated with the two largest publicly traded chains: Fresenius and DaVita.
8. Letter from Rep. Bill Thomas, chairman, House Committee on Ways and Means, to Mark McClellan, administrator, Centers for Medicare and Medicaid Services, 25 April 2006.
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11. Clinical trials have shown that a 3 percent increase in hematocrit value may require as much as a 50 percent increase in epoetin dose. A. Besarab et al., "The Effects of Normal as Compared with Low Hematocrit Values in Patientswith Cardiac Disease Who Are Receiving Hemodialysis and Epoetin," New England Journal of Medicine 339, no. 9 (1998): 584-590. The CMS disseminated a letter soliciting "scientific information from the ESRD community in order to develop a permanent evidence-based policy for EPO monitoring...removing some of the financial incentive that currently promotes overutilization of the drug." Open Letter from Sean Tunis, chief medical officer, CMS, 22 September 2003.
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19. See, for example, K.C. Johnston, "What Are Surrogate Outcome Measures and Why Do They Fail in Clinical Research?" Neuroepidemiology 18, no. 4 (1999): 167-173.
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22. See, for example, CMS, "Decision Memo for Abarelix for the Treatment of Prostate Cancer," 15 March 2005, http://www.cms.hhs.gov/mcd/ viewdecisionmemo.asp?id=129 (accessed 8 June 2006).
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29. "Guideline for Industry Dose-Response Information to Support Drug Registration, ICH-E4," Federal Register 59 (9 November 1994): 55972.
30. The situation is not unique to epoetin. In 1997 Congress passed the FDA Modernization Act with a new section 506B (21 U.S.C. 356b) that provided additional authority for monitoring the progress of postmarketing studies but no enforcement power. Two-thirds of the 1,231 studies that companies promised have not started.
31. Letter from Robert Church, senior counsel, Amgen Inc., to Dennis Cotter, Medical Technology and Practice Patterns Institute, 10 September 2002; and letter from Robert H. Brauer, vice president of lawand associate general counsel, Amgen Inc., to Cotter, 12 December 2001.
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38. Analysis of administrative datamust grapplewith the confounding effects of unobserved events. See Medical Technology and Practice Patterns Institute, "An Opportunity to Improve Quality of Care in the Medicare Program using Enhanced Administrative Data," http://www.mtppi.org/frameset.asp?Pg=/ physio.asp&MI (accessed 31 May 2006).
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