Looking for the outcomes we love in all the wrong places: The questionable value of biomarkers and investments in chronic care disease management interventions

Journal of Managed Care Pharmacy

Volumn 14, Issue 6, 2008, Pages 563-570

  Curtiss, Frederic R ^a   Fairman, Kathleen A ^a  

^a Academy of Managed Care Pharmacy   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACARBOSE; ANTIDIABETIC AGENT; ATORVASTATIN; BIOLOGICAL MARKER; C REACTIVE PROTEIN; CHOLESTEROL; EXENDIN 4; EZETIMIBE PLUS SIMVASTATIN; FIBRIC ACID DERIVATIVE; GLICLAZIDE; GLUCOSE; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; INDAPAMIDE; INSULIN; LIPID; LOW DENSITY LIPOPROTEIN CHOLESTEROL; METFORMIN; NICOTINIC ACID; PERINDOPRIL; PIOGLITAZONE; PLACEBO; PRAVASTATIN; ROSIGLITAZONE; SIMVASTATIN; SULFONYLUREA; TORCETRAPIB;

ATHEROSCLEROSIS; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; CONSENSUS DEVELOPMENT; CORONARY ARTERY DISEASE; COST CONTROL; COST EFFECTIVENESS ANALYSIS; DIABETIC MICROANGIOPATHY; DIABETIC NEPHROPATHY; DRUG APPROVAL; DRUG FATALITY; DRUG RESEARCH; DRUG SAFETY; EDITORIAL; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; GLYCEMIC CONTROL; HEALTH CARE COST; HEALTH CARE QUALITY; HEALTH PROGRAM; HEART FAILURE; HEART INFARCTION; HUMAN; HYPOGLYCEMIA; INVESTMENT; MANAGED CARE; MEDICARE; METHODOLOGY; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PATIENT CARE; PRACTICE GUIDELINE; SIDE EFFECT; WEIGHT GAIN;

EID: 51349162191     PISSN: 10834087     EISSN: None     Source Type: Journal    
DOI: 10.18553/jmcp.2008.14.6.563     Document Type: Editorial

References (47)

1. Narcissus (mythology). Wikipedia.com. Available at: http://en.wikipedia.org/wiki/Narcissus_(mythology). Accessed July 15, 2008.
2. Ullman K. Medicare dives into disease management: pilot program coordinates care of diabetes, other chronic illnesses. DOC News. 2006;3(9):1. Available at: http://docnews.diabetesjournals.org/cgi/ Content/full/3/9/1-a. Accessed July 15, 2008.
3. McCall N, Cromwell J, Bernard S. Evaluation of Phase I of Medicare Health Support (Formulary Voluntary Chronic Care Improvement) Pilot Program Under Traditional Fee-for-Service Medicare: Report to Congress. June 2007. Available at www.cms.hhs.gov/reports/downloads/McCall.pdf. Accessed July 15, 2008.
4. Mattke S. Is there a disease management backlash? Am J Manag Care. 2008;14(6):349-50.
5. Fitch K, Iwasaki K, Kalin D, Pyenson B. Cost trends for chronic-condition cohorts with Medicare benefits. Milliman Research Report. May 2008. Available at: www.milliman.com/expertise/healthcare/ publications/rr/pdfs/cost-trends-for-chronic-condition-RR5-1-08.pdf. Accessed June 17, 2008.
6. Foote SM. Population-based disease management under fee-for-service Medicare. Health Aff (Millwood). 2003;suppl Web exclusives W3-342-56.
7. Crippen DL. Disease management in Medicare: Data analysis and benefit design issues. Congressional Budget Office Testimony before the Special Committee on Aging, U.S. Senate, September 19, 2002. Available at: www.cbo.gov/doc.cfm?index=3776&ty%20pe=0. Accessed July 15, 2008.
8. Goetzel RZ, Ozminkowski RJ, Villagra VG, Duffy J. Return on investment in disease management: a review. Health Care Financ Rev. 2005;26(4):1-19.
9. Rubin RJ, Dietrich KA, Hawk AD. Clinical and economic impact of implementing a comprehensive diabetes management program in managed care. J Clin Endocrinol Metab. 1998;83(8):2635-42.
10. Domurat ES. Diabetes managed care and clinical outcomes: the Harbor City, California Kaiser Permanente Diabetes Care System. Am J Manag Care. 1999;5:1299-307.
11. Warsi A, Wang PS, LaValley MP, Avorn J, Solomon DH. Self-management education programs in chronic disease: a systematic review and methodological critique of the literature. Arch Intern Med. 2004;164:1641-49.
12. Rich MW, Beckham V, Wittenberg C, Leven CL, Freedland KE, Carney RM. A multidisciplinary intervention to prevent the readmission of elderly patients with congestive heart failure. N Engl J Med. 1995;333(18):1190-95.
13. Stewart S, Vandenbrook AJ, Pearson S, Horowitz JD. Prolonged beneficial effects of a home-based intervention on unplanned readmissions and mortality among patients with congestive heart failure. Arch Intern Med. 1999;159(3):257-61.
14. Cline CMJ, Israelsson BYA, Willenheimer RB, Broms K, Erhardt LR. Cost effective management programme for heart failure reduces hospitalization. Heart. 1998;80:442-46.
15. Laramee AS, Levinsky SK, Sargent J, Ross R, Callas P. Case management in a heterogenous congestive heart failure population: A randomized controlled trial. Arch Intern Med. 2003;163:809-17.
16. Fitch K, Pyenson B. Taking stock of wellness. Benefits Q. Second quarter, 2008:34-40. Available at: www.milliman.com/expertise/healthcare/ publications/published/taking-stock-of-wellness-PA04-01-8.php. Accessed June 22, 2008.
17. Krumholz HM, Lee TH. Redefining quality - implications of recent clinical trials. N Engl J Med. 2008;358(24):2537-40.
18. Barter PJ, Caulfield M, Eriksson M, et al., for the ILLUMINATE Investigators. Effects of torcetrapib in patients at high risk for coronary events. N Engl J Med. 2007;357(21):2109-22.
19. Winslow R. Stakes remain high in Merck, Schering-Plough drug study. Wall Street Journal. December 17, 2007:B3.
20. Kastelein JJP, Akdim F, Stroes ESG, et al. for the ENHANCE Investigators. Simvastatin with or without ezetimibe in familial hypercholesterolemia. N Engl J Med. 2008;358(14):1431-43. (Erratum. N Engl J Med. 2008,358(18):1977.)
21. Brown BG, Taylor AJ. Does ENHANCE diminish confidence in lowering LDL or in ezetimibe? N Engl J Med. 2008;358(14):1504-07.
22. Drazen JM, Jarcho JA, Morrissey S, Curfman GD. Cholesterol lowering and ezetimibe. N Engl J Med. 2008;358(14):1507-08.
23. Parker-Pope T. 8-year-olds on statins? A new plan quickly bites back. New York Times. July 8, 2008.
24. Anonymous. For safety, NHLBI changes intensive blood sugar treatment strategy in clinical trial of diabetes and cardiovascular disease. NIH News. February 6, 2008. Available at: www.nih.gov/news/health/ feb2008/nhlbi-06.htm. Accessed February 7, 2008.
25. Gerstein HC, Miller ME, Byington RP, et al. for the Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med. 2008;358(24):2545-59.
26. The ADVANCE Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008; 358(24):2560-72.
27. Stockl KM, Tjioe D, Gong S, Stroup J, Harada ASM, Lew HC. Effect of an intervention to increase statin use in Medicare members who quality for a medication therapy management program. J Manag Care Pharm. 2008; 14(6):532-40.
28. Drug prices from www.drugstore.com. $25.32 per 30-day supply for simvastatin 40 mg per day versus $93.31 per 30-day supply for Crestor 10 mg per day versus $111.99 per 30-day supply of Lipitor 20 mg. Accessed July 6, 2008.
29. Shepherd J, Blauw GJ, Murphy ME, et al. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet. 2002;360:1623-30.
30. Starner CI, Schafer JA, Heaton AH, Gleason PP. Rosiglitazone and piolglitazone utilization from January 2007 through May 2008 associated with four risk-warning events. J Manag Care Pharm. 2008;14(6):523-31.
31. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007; 356(24):2457-71. Available at: http://content.nejm.org/cgi/Content/ full/356/24/2457. Accessed July 6, 2008.
32. Rubenstein S. Glaxo letter defends Avandia. Wall Street Journal. May 31, 2007:D6.
33. FDA News. FDA issues safety alert on Avandia. May 21, 2007 (P07-88). Available at: www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html. Accessed July 14, 2008.
34. FDA News. Manufacturers of some diabetes drugs to strengthen warning on heart failure risk. August 14, 2007. Available at: www.fda.gov/bbs/ topics/NEWS/2007/NEW01683.html. Accessed July 6, 2008.
35. Dluhy RG, McMahon GT. Intensive glycemic control in the ACCORD and ADVANCE trials. N Engl J Med. 2008;358(24):2630-33.
36. Anonymous. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34): UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352:854-65. (Errattum. Lancet. 1998;352:1558.)
37. U.S. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Endocrinologic and Metabolic Drugs Advisory Committee Meeting. July 1-2, 2008. Available at: www.fda.gov/ohrms/dockets/ac/08/ agenda/2008-4368al-draft.pdf. Accessed July 2, 2008.
38. Favole JA, Mundy A, Diabetes drugs face tougher rules. Wall Street Journal. June 28-29, 2008:B7.39 U.S. Food and Drug Administration. Center for Drug Evaluation and Research. Background introductory memorandum. The role of cardiovascular assessment in the pre-approval and post-approval settings for drugs and biologics developed for the treatment of type 2 diabetes mellitus. Guidance for industry: diabetes mellitus: developing drugs and therapeutic biologics for treatment and prevention. February 13, 2008. Available at: www.fda.gov/ohrms/dockets/ ac/08/briefing/2008-4368bl-01-FDA.pdf. Accessed July 2, 2008.
39. Favole JA. FDA urged to test diabetes drugs' heart risk. Wall Street Journal. July 2, 2008:D3.
40. Associated Press. FDA panel urges upgrade of diabetes-drug standards. Wall Street Journal. July 3, 2008:B11.
41. Shaneyfelt TM, Mayo-Smith MF, Rothwangl J. Are guidelines following guidelines? The methodological quality of clinical practice guidelines in the peer-reviewed methodological literature. JAMA. 1999;281(20):1900-05.
42. Ramsey S, Willke R, Briggs A, et al. Good research practices for cost-effectiveness analysis alongside clinical trials: The ISPOR RCT-CEA task force report. Value Health. 2005;8(5):521-33.
43. Starfield B, Hyde J, Gervas J, Health I. The concept of prevention: a good idea gone astray? J Epidemiol Community Health. 2008;62:580-83.
44. National Public Health Partnership. Preventing chronic disease: a strategic framework. Background paper. Melbourne, Australia: National Public Health Partnership; 2001.
45. Bentzen N. WONCA Dictionary of General/Family Practice. Copenhagen, Denmark: Laegeforeningens, Forlag; 2003. Available at: www.globalfamilydoctor.com/dictionaryW/ Dictionary%20of%20General-Family%20Practice.htm. Accessed July 25, 2008.
46. Association of state and territorial chronic disease program directors. Defining roles for public health in secondary/tertiary prevention of cardiovascular disease. Cited in Mensah GA, Dietz WH, Harris VB, et al. Centers for Disease Control and Prevention. Prevention and control of coronary heart disease and stroke - nomenclature for prevention approaches in public health: a statement for public health practices from the Centers for Disease Control and Prevention. Am J Prev Med. 2005;29(5 suppl 1): 152-57.
47. Gofrit ON, Sherner J, Leibovici D, et al. Quarternary prevention: a new look at an old challenge. Isr Med Assoc J. 2000;2(7):498-500.