Precautionary bias

Abstract

In June 2016, the European Commission presented criteria to identify endocrine disruptors in the field of plant protection products and biocides.1 The documents approved are instruments for the move to the practice from the WHO general approach with its definition ‘Endocrine disruptors are substances, both natural and chemical, that can alter the functions of the hormonal system and consequently cause adverse effects on people or animals’.2 The further excerpt provides the understanding of the state of the science under the regulatory efforts: ‘although it is clear that certain environmental chemicals can interfere with normal hormonal processes, there is weak evidence that human health has been adversely affected by exposure to endocrine-active chemicals. However, there is sufficient evidence to conclude that adverse endocrine‐mediated effects have occurred in some wildlife species’. This was concluded in 2002, and in 2012 (latest report2) evidence base did not improved significantly. Especially, it is weak for the effects in humans. It would not be a hyperbolae to say that there is no direct evidence that ‘endocrine disruptors’ as natural or synthetic substances in the environment are harmful to people. The case of endocrine disruptors is just a recent example of how the weak scientific evidence base may became a foundation of efforts of a enormous scale and cost. On the surface, it is the patient demand that move the regulating bodies to approve the drugs, which have to be tested more to obtain the reliable estimate of their efficacy and safety. In the public health, there is the communities’ demand for better and safer living conditions. The worries of the interest groups push the government bodies to introduce the public health protection legislation before the reliable proof of the harm is found, or before the efficacy of the protective/treatment measures is tested. The good example is the recent Russian legislation banning totally the genetically modified organisms and their products (yes, literally including the insulins). The precautionary thinking appears as a reasonable instrument of minimization of harm. The precautionary approach does not oppose the evidence-based approach. What is happening, the subjective impressions of the danger, the concerns move the decision-making despite the absence or weakness of the reliable scientific data. When precautionary decisions are made on the personal level, the unnecessary treatment may be not very harmful for the individual, e.g. using antibiotics for common cold. When a drug is authorized for marketing without the sufficient evidence of its efficacy and safety – not a rare case – it does not harm most of the population, usually few are harmed, and the cost to the society is not significant. When precautionary principle triumphs in the public health, it may be a catastrophe. The international scale efforts may overload the public health control bodies of the states, bother the business and public life and cause the significant direct and indirect costs to society. The examples of the huge spending for research and regulatory efforts without good evidence were aluminium worries of 1980-s, iron in 1990-s, diet cholesterol, animal fat and carotenoids guidelines for the last quarter of the previous century, just to name a few. The cause of this habit to set aside the evidence when there is an influential party, in the case of drugs may be the interests of the drug industry. But in the public health the role of the scientists appears decisive. Scientists offer their research and hard sell them to the public, spinning, exaggerating the findings, and politicians are happy to regulate the food, air and water, and what else. The public welcome the new regulated brave world at any cost.3 Next industry is ready to offer the water filters and cholesterol-free ice cream, and whatever appears profitable. At this step, the scientist have to be near hero to analyse critically the new well-established practice. The ‘precautionary principle’ in health protection, which appeared promising,4 yet functions as an excuse for bias against the scientific evidence and leads to the enormous costs for the society. Conflicts of interest: None declared.