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DrugsAspirinWhen Will Malpractice Lawsuits Be Filed Against Armchair Doctors?

When Will Malpractice Lawsuits Be Filed Against Armchair Doctors?

Blog Commentary

Ferket and colleagues could have added to their long list a guideline from the Haute Autorité de Santé (High Authority for Health, the French agency for quality of care) which recommended in 2006 for the screening peripheral artery disease and its treatment with aspirin, despite evidence was lacking.(1,2)

This French recommendation is surprising because: a) aspirin does not have a marketing authorization for such a use; b) it was even published in the official bulletin of the French republic to enforce good clinical practices.(3)

Guidelines are generally characterized by poor methodology but the main concern is the neurotic quest of many bodies to issue recommendations for acting despite poor evidence. Only the US Preventive Services Task Force (USPSTF) dare to recommend against routine screening for peripheral arterial disease (Grade: D) as evidence was lacking.(4)

From April 1998 to October 2008, the Aspirin for Asymptomatic Atherosclerosis trial screened 28,980 men and women aged 50 to 75 years, free of clinical cardiovascular disease.(5) Of those, 3,350 with a low ankle brachial index (< or = 0.95) were entered in an intention-to-treat double-blind randomized controlled trial comparing aspirin vs placebo. Aspirin resulted in neither reduction in mortality nor reduction in cardio-vascular events but caused major hemorrhage (HR, 1.71; 95% CI, 0.99-2.97).

Five of the guidelines scrutinized by Ferket and colleagues advocated for screening.(1) This was waste of money as systematic reviews for a complex clinical topic may cost in the range of $300,000 to $350,000 or more (communication from Beth A. Collins Sharp, director, Evidence-Based Practice Centers Program, Agency for Healthcare Research and Quality, November 14, 2008). Failure to withdraw or to update these five guidelines enduringly results in inappropriate care to healthy people.

— Alain Braillon MD, PhD, France

1 Ferket BS, Spronk S, Colkesen EB, Hunink MG. Systematic Review of Guidelines on Peripheral Artery Disease Screening. Am J Med. 2011 Nov 11 doi:10.1016/j.amjmed.2011.06.027

2 Haute Autorité de Santé. Prise en charge de l’artériopathie chronique oblitérante athéroscléreuse des membres inférieurs – Indications médicamenteuses, de revascularisation et de rééducation. April 2006 Available at http://www.has-sante.fr/portail/upload/docs/application/pdf/AOMI_fiche.pdf Accessed 20 Dec 2011.

3 Avenant à l’accord de bon usage des soins relatif à l’utilisation des antiagrégants plaquettaires NOR : SJSU0722012X Journal Officiel de la République Française. 19 December 2007 Texte 33 sur 143.

4 U.S. Preventive Services Task Force. Screening for Peripheral Arterial Disease. August 2005 current as of December 2011. Available at http://www.uspreventiveservicestaskforce.org/uspstf/uspspard.htm Accessed 20 Dec 2011.

5 Fowkes FG, Price JF, Stewart MC et al. Aspirin for prevention of cardiovascular events in a general population screened for a low ankle brachial index: a randomized controlled trial. JAMA. 2010 ;303:841-8

NOTE: Conflict of interests– Dr Braillon, a senior tenured consultant in Public Health was sacked in Sept 2010 by the National Management Centre (French Department of Health) against the advice of the National Statutory Committee. He won a lawsuit in Sept 2011 against the Haute Autorité de Santé for breach of the Freedom of Information Act but the Haute Autorité de Santé failed to apply the judgment.(Lee SS. The power of one and saving private Braillon. Liver Int 2012;32:1)

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