Practice Guidelines Fail - Again!
Richard Amerling, M.D.
Practice Guidelines Fail - Again!

By Richard Amerling, M.D.,

Yet another expensive drug has been withdrawn from the market, even though it was "recommended" in a prestigious "practice guideline."

This month’s casualty is Eli Lilly’s Xigris (drotrecogin alfa). A large clinical study (PROWESS-SHOCK) failed to show that the drug was any better than placebo for saving the lives of patients with sepsis (a serious infection in the blood). But there was never much fact behind its use. A recommendation from the Surviving Sepsis Guideline panel (sponsored heavily by Lilly) to give Xigris to certain patients with sepsis was based on very flimsy evidence. In a critique published in 2009, more than two years ago, my colleagues and I characterized the guidelines, and subsequent campaign to promote them, as little more than advertising for Xigris.

Is this an isolated case? Unfortunately, no. Practice guidelines are commonly funded by industry, and panelists overwhelmingly have financial relationships with industry, either through research grants, consulting fees, or speaker honoraria. These are conflicts of interest, and cannot help but create bias.

In 2003, the National Kidney Foundation (NKF) published guidelines for treatment of bone disease in patients with kidney disease. Due to a dearth of good evidence, these were largely the opinions of a panel of doctors, most of whom had financial relationships with manufacturers of bone-related drugs. One company in particular, Amgen, used the guidelines as a marketing tool for Sensipar, a drug used to treat kidney-related bone disease. In addition to financing many of the panelists, Amgen provided multimillion-dollar grants to the NKF for the creation of their guideline group (Kidney Disease Outcomes Quality Initiative, or KDOQI).

NKF-KDOQI also published guidelines for the treatment of anemia in dialysis patients that became incorporated into clinical performance measures used to grade, and ultimately pay, dialysis providers. The “targets” were set high based on observations that patients who died tended to be more anemic than those who survived. Prospective studies failed to show benefit from the drug treatment—but not before thousands of patients were over-treated, and possibly harmed. Again, Amgen, manufacturer of Epogen (recombinant human erythropoietin) benefited mightily from these guidelines.

Members of the Joint National Committee for the Detection, Prevention and Treatment of Hypertension (JNC) and the Adult Treatment Panel (ATP) of the National Cholesterol Education Program (both under the National Heart, Lung and Blood Institute) are almost all heavily funded by industry. Such funding (which is likely a significant portion of gross revenue for these academic doctors) must create bias towards treatment; a bias that is evident on reading the guidelines. The JNC suggests that hypertension is a “continuum of risk.” Such thinking leads to the notion that incremental lowering of pressure provides continuous benefit and has been used to justify aggressive treatment in patients who will almost certainly not benefit. The same approach is seen for LDL cholesterol, where treatment targets are regularly moved lower. JNC and ATP have led to the over-treatment of millions of individuals.

More recently, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended that boys ages 11 and 12 routinely receive Merck’s HPV (human papillomavirus) vaccine. It would be good to know what, if any, financial conflicts of interest might exist for members of the ACIP. A thorough review of the CDC website failed to turn up a financial disclosure page. Are there any investigative journalists out there willing to make some phone calls?

Practice guidelines clearly can be harmful to patients, but they acquire a regrettable authority and will be the basis for the centralized control of medical practice through “payment for performance” and algorithms inserted into electronic medical records. Is it any wonder the pharmaceutical industry supported the Affordable Care Act?


Richard Amerling, MD is a nephrologist practicing in New York City. He is an Associate Professor of clinical medicine at Albert Einstein College of Medicine in New York, and the Director of Outpatient Dialysis at the Beth Israel Medical Center. Dr. Amerling studied medicine at the Catholic University of Louvain in Belgium, graduating cum laude in 1981. He completed a medical residency at the New York Hospital Queens and a nephrology fellowship at the Hospital of the University of Pennsylvania. He has written and lectured extensively on health care issues and is a Director of the Association of American Physicians and Surgeons. Dr. Amerling is the author of the Physicians' Declaration of Independence.

Watch Dr. Amerling's Presentation,
"Practice Guidelines - More harm than good?"
AAPS 68th Annual Meeting - September 30, 2011

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