Am Fam Physician. 2008 Jan 1;77(1):30.
to the editor: The editorial on U.S. statin guidelines by Drs. Barry and Hoffman in the May 15, 2007, issue of American Family Physician1 draws attention to a serious issue: the influence of parties with inherent economic interests on the production of practice guidelines.
The authors join the chorus of concern over the pharmaceutical industry's influence in crafting guidelines for chronic conditions, such as hypertension2 and diabetes,3 and acute critical situations, such as sepsis.4 The industry has specifically targeted chronic diseases, which require long-term drug therapy (for example, chronic obstructive pulmonary disease, chronic stable angina, depression, diabetes mellitus, hypercholesterolemia, hypertension, and rheumatoid arthritis).5 Although some degree of altruism motivates these involvements, the economic incentives to push for inclusion of a company's products in the guidelines cannot be ignored.
The situation is significantly complicated by the fact that guidelines now serve as more than a “guide.” With the recent shift toward pay-for-performance by third-party payers, physician reimbursement is based not on services provided, but on outcomes. In theory, this is a marvelous idea. Unfortunately, because most real outcomes for chronic diseases take years to manifest, quality is defined by insurers in terms of process measures—i.e., strict adherence to guidelines (which may not correlate with meaningful clinical outcomes6). Performance on these measures may also be publicly reported, affecting patients' choice of physician. This sets the stage for a sinister situation: guidelines that are crafted to motivate physicians in a way far more insidious and powerful than the trinkets provided by drug representatives (or journal advertising). It would be a financial win-win situation for the physician and the drug company, with only the patient losing.
It is critical that physicians, policy makers, and patients heed the warning of Drs. Barry and Hoffman and insist that guidelines be carefully formulated and their use by all parties closely scrutinized.
Author disclosure: Nothing to disclose.
1. Barry HC, Hoffman JR. U.S. statin guidelines: expensive but not necessarily effective. Am Fam Physician. 2007;75(10):1453–1456.
2. Sandvik H. About the 1999 World Health Organization—International Society of Hypertension Guidelines for the Management of Hypertension [Letter]. 1999. http://www.uib.no/isf/letter. Accessed August 31, 2007.
3. Clinical practice guidelines and conflict of interest [Published correction appears in CMAJ. 2006;174(1):67]. CMAJ. 2005; 173(11):1297.
4. Eichacker PQ, Natanson C, Danner RL. Surviving sepsis—practice guidelines, marketing campaigns, and Eli Lilly. N Engl J Med. 2006;355(16):1640–1642.
5. Kotsanos JG. Development of performance measures for seven chronic diseases. Health Outcomes Work Group of the Pharmaceutical Research and Manufacturers of America. Jt Comm J Qual Improv. 1997;23(3):150–161.
6. Fonarow GC, Abraham WT, Albert NM, et al. Association between performance measures and clinical outcomes for patients hospitalized with heart failure. JAMA. 2007;297(1):61–70.
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