Fernando Alcoforado*
This article aims to present the methods adopted by science used in the validation of medicines and vaccines. This presentation is extremely important to show readers that no medicine or vaccine should be used without be validated by the scientific method, that is, it cannot be used without undergoing rigorous tests to prove its efficacy and safety for its users. This clarification is very important because in Brazil and in the world advocates of drugs and early treatment of covid-19 have emerged without any demonstration of its scientific validity, compromising the fight against the new coronavirus pandemic and contributing to the growth of infected and dead with the escalation of the pandemic. What happened millennia ago, when medicine was based on popular beliefs to treat or prevent certain diseases so that everyone could start using it, is currently happening in Brazil and in several countries around the world. These absurd behaviors happened again in Brazil with the new coronavirus pandemic practiced by President Jair Bolsonaro, his followers and, even surprisingly, by some doctors who suggest the adoption of drugs and early treatment of covid-19 without any scientific basis.
These absurd behaviors stopped occurring in the past when medicine managed to incorporate the scientific method into its daily practice. Hippocrates (460 BC-377 BC), Greek physician, considered the father of Medicine, the most famous physician of Antiquity, was the initiator of clinical observation. It was Hippocrates who laid the foundations for a rational approach to medicine. Hippocrates’ writings bring together more than seventy treatises covering a wide range of subjects, emphasizing the importance of treatment and prognosis. Hippocrates suggested that physicians abandon subjective analysis and observe the patient. Objectivity is the basis of Hippocratic medicine and observed in today’s medical practices. Rationalism was first applied to medicine with Hippocrates. In Europe, however, this relationship suffered a hiatus during the Middle Ages (between the 5th and 15th centuries), when diseases were once again attributed to divine causes and churches became the sites of miraculous cures. It was during the Renaissance that modern medicine began in Europe. Scientists and researchers broke away from the traditional view based on the divine order that justified diseases and their treatment. Treatments started to be determined by observations, experiments and conclusions supported by scientific research.
It is exactly the scientific method that makes it possible for medicines to cure diseases and vaccines to prevent their occurrence to be accepted by the scientific community and also by the government agencies responsible for approving their use in each country. The scientific method comprises two complementary knowledge approaches: the empirical (inductive) and the rational (deductive) (Figure 1). In the inductive approach, used in descriptive sciences such as biology, anatomy and geology, general principles are extracted from the analysis of data collected through observation and experimentation. The inductive or induction method consists of the accurate and valid recording of experiments and observations on what is the object of research, constituting the empirical basis of all branches of Science, including Medicine. Induction allows the establishment of general propositions about a class of phenomena based on the analysis of a limited number of experiments and observations of selected elements. For example, having found penicillin to be useful in curing pneumonia in a limited number of patients, its widespread use is proposed.
In the deductive method, used in mathematics and theoretical physics, truths are derived from elementary principles that have to be evaluated based on experiments and/or observations. It is worth noting that the deductive method is used in philosophy, in the formulation of scientific laws, in education and is used in solving problems in physics and mathematics. This method is generally used to test existing hypotheses in order to prove theories. Therefore, it is also called the hypothetical-deductive method. The deductive method starts from a universal proposition that, through logical reasoning, arrives at a valid conclusion. So, in this kind of logical reasoning, a conclusion is reached from the premises. The deductive method does not add new information to the conclusion since it arises from what was already implied in the premises. The deductive method is a logical thinking framework that allows you to test the validity of existing information. This is the case of evidence-based medicine that uses the deductive method as a process of systematically discovering, evaluating and using research findings as a basis for clinical decisions.
The Scientific Method inductive and deductive are represented in a simplified and schematic way in Figure 1:
Figure 1- The Scientific Method
The advances in Science, over the last few centuries, are due to the development of increasingly powerful instruments to aid observation. The essential characteristics for an observation to be considered scientific are its accuracy, validity and reproducibility. Observations, when properly synthesized and confirmed by others, constitute the factual, empirical basis of scientific knowledge. Scientific theories must lead to the formulation of a set of empirically verifiable propositions, that is, verifiable hypotheses. After evidence has been collected, the researcher decides whether or not the findings are consistent with the predictions of the hypothesis. If the hypothesis is confirmed by the evidence, then the theory from which the hypothesis came is strengthened or verified. However, when the data do not confirm the hypothesis, the theory is rejected.
If a theory fails to predict or explain observations, it becomes useless, and is usually replaced by new, stronger and more consistent theories. It was the application of the scientific method described above that allowed the spectacular growth of scientific knowledge that we have witnessed in the last centuries and, in particular, in the last hundred years. This is how the scientific method helps to describe and explain the results of scientific research. It is important to note that the scientific method concerns a set of basic rules of how the procedure should be to produce scientific knowledge, be it new knowledge, a correction or an increase in previously existing knowledge. In most scientific disciplines, the scientific method consists of gathering verifiable empirical evidence based on systematic and controlled observation, usually resulting from laboratory or field experiments or research, and analyzing it using logic. The scientific method is nothing more than logic applied to science.
Scientific validation of products and processes in the pharmaceutical industry consists of carrying out a series of studies based on the scientific method that aims to prove whether a particular product, process, equipment, activity or procedure really works. It is a way of proving that the pharmaceutical industry will produce any medicine or vaccine following a predetermined and safe way, thus being able to be used repeatedly in different situations. It is important to note that the purpose of clinical trials of drugs or vaccines is to validate them as efficient and safe. For this, a series of investigation procedures are carried out to prove the safety (information about adverse effects) and efficacy of the medicine or vaccine in question, ensuring patient safety. In other words, clinical tests (or trials) are studies carried out with humans and serve to prove whether a drug works safely and effectively. Clinical trials assess the pharmacological and adverse effects of a vaccine or drug, as well as how it is absorbed, metabolized and excreted by the human body. They are the last step in a long process of researching a drug or vaccine. All vaccines in use in the world to immunize the world population of covid-19 have gone through this process to be accepted by the scientific community.
The WHO (World Health Organization) published an article under the title Como são as vacinas desenvolvidas? (How are vaccines developed?) Available on the website <https://www.who.int/pt/news-room/feature-stories/detail/how-are-vaccines-developed?gclid=CjwKCAjwiLGGBhAqEiwAgq3q_mWO4loToQxF38cHX6avtgy_R3piirzzpIGoTJOvg89sZ4EfvfZ7oBoCjEAQAvD_BwE>. In this article, there is information that most vaccines have been used for decades, with millions of people receiving them safely every year. As with drugs, all vaccines must undergo lengthy and rigorous testing to ensure their safety before they can be introduced into a country’s vaccination program. Each vaccine under development must first undergo testing and evaluation to determine which antigen should be used to elicit an immune system response. This pre-clinical phase is done without testing in humans. An experimental vaccine is first tested on animals to assess its safety and potential to prevent the disease. If the vaccine triggers an immune response, it is tested in human clinical trials in three phases.
In Phase 1, the vaccine is inoculated into a small group of volunteers to assess its safety, confirm whether it generates an immune system response, and determine the right dosage. Generally, at this stage, vaccines are tested on young volunteers and healthy adults. In Phase 2, the vaccine is administered to several hundred volunteers to further assess its safety and ability to generate an immune system response. Participants in this phase have the same characteristics (age, gender) for which the vaccine is intended. At this stage, usually, several trials are carried out to assess different age groups and different vaccine formulations. A group that has not received the vaccine is usually included at this stage as a comparison group to determine whether the changes in the vaccinated group are attributable to the vaccine or occurred by chance.
In Phase 3, the vaccine is given to thousands of volunteers – and compared to a similar group of people who did not take the vaccine but received a comparison product (placebo) to determine if the vaccine is effective against the disease it is intended for combat and to study its safety in a much wider group of people. Most of the time, phase 3 trials take place in multiple countries and multiple locations within countries to ensure that vaccine performance data apply to many different populations. During Phase 2 and Phase 3 trials, volunteers and scientists participating in the study are prevented from knowing which volunteers received the trial vaccine or comparator product (placebo). This is called a “blind trial”, which is necessary to ensure that neither the volunteers nor the scientists are influenced in their assessment of safety and efficacy, ignoring which product each received.
After the trial is complete and all results are completed, the trial volunteers and scientists are informed who received the vaccine and who received the comparator (placebo). Once the results of all these trials are available, a series of steps, including efficacy and safety analyses, will need to be taken for regulatory and public health approval. This entire process is carried out in compliance with the inductive scientific method to determine the efficacy and safety of a vaccine.
What has just been exposed represents a response to science deniers such as Jair Bolsonaro and his followers who insist on defending the use of drugs proven to be ineffective in curing covid-19 such as chloroquine, hydroxychloroquine, ivermectin, among other drugs, in addition to contributing with adverse side effects. Bolsonaro’s sabotage against efforts to combat the new coronavirus pandemic had a new chapter on the night of June 16, when he returned to attack the CoronaVac vaccine and lied once again when saying that this vaccine developed by the Butantan Institute in partnership with the Chinese drugmaker Sinovac has no scientific proof. Bolsonaro lied in an interview to SIC TV, affiliated with RecordTV, in Rondônia, when he stated that the validity period of CoronaVac is around 6 months, that many people have taken it and do not develop any antibodies and that this vaccine still has no scientific proof. This is an outright lie by Bolsonaro because CoronaVac passed tests based on the scientific method and was scientifically approved by the WHO (World Health Organization) and by Anvisa in Brazil. The behavior of many people in Brazil who, dominated by political blindness, believe in Bolsonaro’s lies is regrettable.
* Fernando Alcoforado, 81, awarded the medal of Engineering Merit of the CONFEA / CREA System, member of the Bahia Academy of Education, engineer and doctor in Territorial Planning and Regional Development by the University of Barcelona, university professor and consultant in the areas of strategic planning, business planning, regional planning and planning of energy systems, is author of the books Globalização (Editora Nobel, São Paulo, 1997), De Collor a FHC- O Brasil e a Nova (Des)ordem Mundial (Editora Nobel, São Paulo, 1998), Um Projeto para o Brasil (Editora Nobel, São Paulo, 2000), Os condicionantes do desenvolvimento do Estado da Bahia (Tese de doutorado. Universidade de Barcelona,http://www.tesisenred.net/handle/10803/1944, 2003), Globalização e Desenvolvimento (Editora Nobel, São Paulo, 2006), Bahia- Desenvolvimento do Século XVI ao Século XX e Objetivos Estratégicos na Era Contemporânea (EGBA, Salvador, 2008), The Necessary Conditions of the Economic and Social Development- The Case of the State of Bahia (VDM Verlag Dr. Müller Aktiengesellschaft & Co. KG, Saarbrücken, Germany, 2010), Aquecimento Global e Catástrofe Planetária (Viena- Editora e Gráfica, Santa Cruz do Rio Pardo, São Paulo, 2010), Amazônia Sustentável- Para o progresso do Brasil e combate ao aquecimento global (Viena- Editora e Gráfica, Santa Cruz do Rio Pardo, São Paulo, 2011), Os Fatores Condicionantes do Desenvolvimento Econômico e Social (Editora CRV, Curitiba, 2012), Energia no Mundo e no Brasil- Energia e Mudança Climática Catastrófica no Século XXI (Editora CRV, Curitiba, 2015), As Grandes Revoluções Científicas, Econômicas e Sociais que Mudaram o Mundo (Editora CRV, Curitiba, 2016), A Invenção de um novo Brasil (Editora CRV, Curitiba, 2017), Esquerda x Direita e a sua convergência (Associação Baiana de Imprensa, Salvador, 2018, em co-autoria) and Como inventar o futuro para mudar o mundo (Editora CRV, Curitiba, 2019).
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