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

Fuchs, Flávio Danni

doi:10.1590/s0100-879x2009000300002

Cited by 13 publications

(6 citation statements)

References 32 publications

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“…At least part of the evidences supporting the existence of such effects may have resulted from biases in the planning and interpretation of clinical trials funded by pharmaceutical companies [23]. …”

Section: Introductionmentioning

confidence: 99%

Prevention of hypertension in patients with pre-hypertension: protocol for the PREVER-prevention trial

Fuchs

Moreira

et al. 2011

Trials

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BackgroundBlood pressure (BP) within pre-hypertensive levels confers higher cardiovascular risk and is an intermediate stage for full hypertension, which develops in an annual rate of 7 out of 100 individuals with 40 to 50 years of age. Non-drug interventions to prevent hypertension have had low effectiveness. In individuals with previous cardiovascular disease or diabetes, the use of BP-lowering agents reduces the incidence of major cardiovascular events. In the absence of higher baseline risk, the use of BP agents reduces the incidence of hypertension. The PREVER-prevention trial aims to investigate the efficacy, safety and feasibility of a population-based intervention to prevent the incidence of hypertension and the development of target-organ damage.MethodsThis is a randomized, double-blind, placebo-controlled clinical trial, with participants aged 30 to 70 years, with pre-hypertension. The trial arms will be chlorthalidone 12.5 mg plus amiloride 2.5 mg or identical placebo. The primary outcomes will be the incidence of hypertension, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new sub-clinical atherosclerosis, and sudden death. The study will last 18 months. The sample size was calculated on the basis of an incidence of hypertension of 14% in the control group, a size effect of 40%, power of 85% and P alpha of 5%, resulting in 625 participants per group. The project was approved by the Ethics committee of each participating institution.DiscussionThe early use of blood pressure-lowering drugs, particularly diuretics, which act on the main mechanism of blood pressure rising with age, may prevent cardiovascular events and the incidence of hypertension in individuals with hypertension. If this intervention shows to be effective and safe in a population-based perspective, it could be the basis for an innovative public health program to prevent hypertension in Brazil.Trial RegistrationClinical Trials NCT00970931.

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Section: Introductionmentioning

confidence: 99%

Prevention of hypertension in patients with pre-hypertension: protocol for the PREVER-prevention trial

Fuchs

Moreira

et al. 2011

Trials

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“…It is well documented that this changing research climate has already had an impact on public confidence in science, which seems to be weaker for industry-related scientific research (21). This issue suggests that addressing COIs could play a fundamental part in efforts to reduce distorted research records, such as those that may be influenced by corporate bias (38) but be taken as sound data by peers and eventually by the public.…”

Section: Discussionmentioning

confidence: 99%

Addressing conflicts of interest in the research paper: a societal demand in contemporary science?

Vasconcelos

Cassimiro

Martins

et al. 2013

Braz J Med Biol Res

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In the last decade, dialogue between science and society has found a forum in an increasing number of publications on topics such as public engagement with science and public trust in science. Concerning the latter, issues that include cases of research misconduct, accountability in research, and conflicts of interest (COIs) have shaped global discussions on the communication of science. In the publication setting, the perception that hiding COIs and/or not managing them well may affect public trust in the research record has grown among editors. We conducted a search for editorials addressing COIs between 1989 and 2011, using four major databases: Medline/PubMed, Embase, Scopus, and Web of Knowledge. We explored the content of these editorials and the relationship they established between COIs and the public trust in science. Our results demonstrate that the relationship between disclosure of COIs and public trust in science has become a major concern among editors. We, thus, argue that COIs should be discussed more openly and frequently in graduate courses in the sciences, around the globe, not only in biomedical but also in non-biomedical areas. This is a critical issue in contemporary science, as graduate students are the future voices and decision-makers of the research community. Therefore, COIs, especially in the broader context of science and society, merit closer attention from policymakers, researchers, and educators. At times of great expectations for public engagement with science, mishandling of COIs may have undesirable consequences for public engagement with science and confidence in the scientific endeavor.

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“…In a recent meta‐analysis by Law and associates, of 147 clinical trials comparing drugs with placebo and with each other [2], all classes of blood pressure lowering drugs had similar efficacy to reducing CHD events and stroke for a given reduction in blood pressure, so excluding material pleiotropic effects. At least part of the evidences supporting the existence of such effects resulted from distortion in the planning and interpretation of clinical trials funded by pharmaceutical companies [25].…”

Section: Prevention Of Cardiovascular Events In Patients With Blood Pmentioning

confidence: 99%

Prehypertension: the Rationale for Early Drug Therapy

Fuchs¹

2010

Cardiovascular Therapeutics

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SUMMARYBlood pressure within prehypertensive levels confers higher cardiovascular risk by two means. At first, these levels are associated with higher risk for cardiovascular events, starting at BP values as low as 115/75 mmHg, and doubling at each 20 mmHg for systolic or 10 mmHg for diastolic BP. Prehypertension is also an intermediate stage for full hypertension, which develops in an annual rate of 7 out 100 individuals with 40-50 years of age. The precocious drug intervention in patients with prehypertension is therefore appealing. In individuals with previous cardiovascular disease or diabetes the use of BP-lowering agents is compulsory, since the 18-42% reduction of major cardiovascular events demonstrated in randomized clinical trials translates in palpable clinical benefit. In the absence of higher baseline risk, the absolute benefit of treatment is presumably small and was not demonstrated to date. These individuals could be candidate to treatment with the aim to prevent the development of full hypertension. The long-lasting effectiveness of non-drug therapies is low outside the controlled conditions of randomized clinical trials, and there are evidences that the use of BP-lowering drugs reduces the incidence of hypertension in individuals with prehypertension by more than 60%. Clinical trials testing the efficacy and safety of BP agents to prevent hypertension in a population-based perspective are required. In the meantime, it is worthy to present the option to start low doses of BP agents for individuals with prehypertension without co-morbidities who do not respond to the prescription of lifestyle modification.

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

Cited by 13 publications

References 32 publications

Prevention of hypertension in patients with pre-hypertension: protocol for the PREVER-prevention trial

Prevention of hypertension in patients with pre-hypertension: protocol for the PREVER-prevention trial

Addressing conflicts of interest in the research paper: a societal demand in contemporary science?

Prehypertension: the Rationale for Early Drug Therapy

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