ISSN: 1885-5857 Impact factor 2023 7.2
Vol. 62. Num. 1.
Pages 103 (January 2009)

Clinical Practice Guidelines and Pulmonary Hypertension: More Disagreements Than Facts

Guías de práctica clínica en la hipertensión pulmonar: más conflictos que evidencia

Nicolás LaffayeaPablo D Comignania

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To the Editor:

We have cautiously read the revision that was made jointly by the Spanish Cardiology Society and the Spanish Pneumology and Thoracic Surgery Society (SEPAR) regarding the care standards for the management and treatment of patients with pulmonary hypertension.1 At least 3 facts are cause for concern.

First, it is striking and alarming that a document signed by two important scientific societies does not present a single independent author. As seen in the publication, each and every one of the authors has links to the manufacturers of the drugs that are used for the treatment of this disease. The independence of the clinical investigation (above all else in society documents and guidelines) cannot be considered to be an "accessory," but rather a fundamental element for guaranteeing the transparency of the opinions. The former editor of the New England Journal of Medicine clearly expressed this, and an extensive bibliographic background supports the need to provide transparency of the opinions of experts and scientific societies.2-4 Even more so, the declaration that "the financing needed for the preparation of this document has been obtained through unconditional support provided to SEPAR and the SEC by Actelion Pharmaceuticals España, Ferrer Grupo, GlaxoSmithKline, Pfizer, and Schering España" makes it almost inadmissible. The pharmaceutical industry is not a charitable entity. It is an opinion shared by many that "unconditional" help does not exist.5

Second, it is notable that a document from 2008 decides to ignore the existing controversy on the available "evidence" related to the quality of the methodology used in the clinical investigation on pulmonary hypertension.6-8

Finally, in the end the document is a quasi-translation of the European Clinical Practice Guidelines. However, this is precisely the point that makes it out of date. In fact, the EMEA is actively reviewing the practicality of continuing to do clinical studies using the same standards that have been created to date. Translating questionable documents for local scientific societies is more imposition of an obedience guide than promoting reflection and critical judgement.

Presenting challenges and proposing opportunities should be the primary concerns of scientific societies.

We should point out that this letter is not designed to create an individual approach, but rather to discuss, openly and in the appropriate field, the role of scientific societies when recommendations are made.

Bibliography
[1]
Barberá JA, Escribano P, Morales P, Gómez MA, Oribe M, Martínez A, et al..
Estándares asistenciales en hipertensión pulmonar..
Rev Esp Cardiol, (2008), 61 pp. 170-84
[2]
Angell M..
Is academic medicine for sale? N Engl J Med, (2000), 342 pp. 1516-8
[3]
Bodenheimer T..
Uneasy alliance —clinical investigators and the pharmaceutical industry..
N Engl J Med, (2000), 342 pp. 1539-44
[4]
Campbell EG, Weissman JS, Vogeli C, Clarridge BR, Abraham M, Marder JE, et al..
Financial relationships between institutional review board members and industry..
N Engl J Med, (2006), 355 pp. 2321-9
[5]
Moynihan R..
Who pays for the pizza? Redefining the relationships between doctors and drug companies..
[6]
Macchia A, Marchioli R, Marfisi R, Scarano M, Levantesi G, Tavazzi L, et al..
A meta-analysis of trials of pulmonary hypertension: a clinical condition looking for drugs and research methodology..
Am Heart J, (2007), 153 pp. 1037-47
[7]
Rich S..
The current treatment of pulmonary arterial hypertension: time to redefine success..
Chest, (2006), 130 pp. 1198-202
[8]
Farber HW..
The Status of Pulmonary Arterial Hypertension in 2008..
Circulation, (2008), 117 pp. 2966-8
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