Peço desculpas aos leitores por não trazer a íntegra do Editorial do BMJ. Há regras de direito autoral que devem ser cumpridas, mesmo no país das fotocópias (O Brasil mesmo).
Para quem tiver interesse, o documento está disponível em BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f755. É possível acessá-lo após cadastro prévio no site.
Segue a resposta, publicada online em 04 de Março de 2012:
The editorial of BMJ brings us highly sensitive issues when it comes to ensuring and protecting the human right to health and dignity. Fundamental rights and, in particular, the dignity of the human person are the foundations of the modern State (the Constitutional State).
The crimes of pharmaceutical companies — represented by behaviors such as encouraging off label usage, publishing fraudulent results and selective publication of clinical trials — affect significantly the access to safe and effective treatments.
The information is usually distorted, which turns the right to health into a huge question mark. Is that new medical supply really safe and effective? Therefore, it is mandatory to spread the idea that the right information is a necessary scope of the right to health. This conclusion allows us to assert that the right to health is qualified by public access to scientific evidence: a right to evidence-based health.
Provided this fundamental idea is widely recognized, it is possible, within the framework of national and international legal provisions, to mitigate (not eliminate) fraud within the pharmaceutical industry.
There are indications that FDAAA is producing positive results. It is important, therefore, that similar laws are reproduced in other countries and under international law, resulting in severe penalties against fraudsters.
The publication and dissemination of results, however, is not sufficient. The design of protocols registered at ClinicalTrials.gov is usually poor. Few studies have methodological design that includes randomization, comparison of intervention with the usual treatment and double-blind masking. Poor methodological studies can induce poor decision-making, which is as damaging as the lack of information.
Another concern is the funding of research: almost 70% of the protocols registered at ClinicalTrials.gov rely, on some extent, on financial support by the industry. It is important to enhance public funding of research, directing funds merely to studies that meet minimal standards of methodological quality [i.e. Jadad scale (i)].
It is not enough, however, the adoption of heterogeneous laws around the globe, according to economic or political disposition of each country. It is important to remember an essential feature of the problem: health is a fundamental right at risk, under attack by huge economic and financial interests. Thus, the patterns of public funding of research should be defined under an international scope, with a homogeneous system of regulations focused on valuing independent research.
Therefore, it is imperative that medical and legal communities join together in favor of a wide publicity of results of clinical trials – across open access platforms -, increased public funding of studies and improved methodological quality of research.
It is known that the best way to fight crime is the certainty of severe penalty [ii]. Fear of punishment always moved legal science. Once the ethical problem of pharmaceutical industry is well defined, it may be time to convene legal experts and international organizations to frighten those who do not seem to be afraid of anyone.
Although criminal proceedings may be slow, there are preventive measures that can be effective against corporate crime (such as prohibition of participation in new research, preventive withdrawal of researchers and directors of pharmaceutical companies, temporary suspension of patent rights, etc.).
International Law cannot put an end to crimes perpetrated by the pharmaceutical industry. Nevertheless, it has all the tools to confront it effectively, in favor of universal, fundamental and human right to health.
i. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996;17:1–12.
ii. Beccaria, C. On Crimes and Punishments. New Jersey: Transaction Publishers, 2011
Competing interests: None declare