The corporate bias and the molding of prescription practices: the case of hypertension

The corporate bias and the molding of prescription practices: the case of hypertension
Flavio D. Fuchs
Serviço de Cardiologia, Hospital de Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brasil
Correspondence to: F.D. Fuchs, Serviço de Cardiologia, Hospital de Clínicas de Porto Alegre,
Rua Ramiro Barcelos, 2350, 90035-903 Porto Alegre, RS, Brasil
Fax: +55-51-2101-8420. E-mail: ffuchs@hcpa.ufrgs.br
Drug management of hypertension has been a noticeable example of the influence of the pharmaceutical industry on prescription practices. The worldwide leading brands of blood pressure-lowering agents are angiotensin receptor-blocking agents, although they are considered to be simply substitutes of angiotensin-converting enzyme (ACE) inhibitors. Commercial strategies have been based on the results of clinical trials sponsored by drug companies. Most of them presented distortions in their planning, presentation or interpretation that favored the drugs from the sponsor, i.e., corporate bias. Atenolol, an ineffective blood pressure agent in elderly individuals, was the comparator drug in several trials. In a re-analysis of the INSIGHT trial, deaths appeared to have been counted twice. The LIFE trial appears in the title of more than 120 reproductions of the main and flawed trial, as a massive strategy of scientific marketing. Most guidelines have incorporated the corporate bias from the original studies, and the evidence from better designed studies, such as the ALLHAT trial, have been largely ignored. In trials published recently corporate influences have touched on ethical limits. In the ADVANCE trial, elderly patients with type 2 diabetes and cardiovascular disease or risk factors, allocated to placebo, were not allowed to use diuretic and full doses of an ACE inhibitor,
despite the sound evidence of benefit demonstrated in previous trials. As a consequence, they had a 14% higher mortality rate than the participants allocated to the active treatment arm. This reality should be modified immediately, and a greater independence of the academy from the pharmaceutical industry is necessary.
Key words: Hypertension; Blood pressure agents; Clinical trials; Ethics; Corporate bias
This study was supported, in part, by the National Institute of Science and Technology for Health Technology Assessment
(IATS) - CNPq/Brazil.
Received October 3, 2008. Accepted February 16, 2009