Source: Gazeta do Povo Online - Curitiba / PR - 23/05/2010

Scientific production and investment in research and development of medicines have grown in Brazil in recent years. However, the country is still far from being able to compete with European nations or the United States. The lack of technology, resources, trained researchers and bureaucratic obstacles that delay the approval of research are pointed out as some of the problems.

A decade ago, Brazil was responsible for 0,5% of the world's scientific production. Currently, Brazilian researchers account for 2% of this total. Brazilian investment in pharmaceutical research has grown in recent years. In 2005, R $ 87 million was spent; in 2008, it was R $ 500 million. Even so, the amount does not even reach the amount invested by a multinational in the development of a single drug. To create a new drug, approximately $ 900 million is spent on a process that can take up to 15 years. It is a market that generates, in the United States, at least US $ 60 billion a year. A risky business when one takes into account that out of ten thousand molecules surveyed, only one ends up being launched on the market and, on average, seven out of ten new drugs do not cover the investment made for its creation.

Although it managed to enter the international circuit of multicentric studies, Brazil, in most cases, only participates only in the final stages of the research. In order to develop a new drug, a series of tests are carried out to check the efficacy, safety, side effects and the indicated dosage. In the first phase of clinical studies (when testing with humans), the medication is administered to healthy individuals in order to determine safety and dosage. Studies of this phase, called I, are rarely done in Brazil. This is because besides having no tradition in basic research, which includes the identification of a molecule with the potential to become a new medicine, Brazil, unlike other countries, does not remunerate study volunteers. “It is difficult for a healthy person to take the risks of being part of a study with a drug in which the effects are not yet known without receiving any benefit in return”, observes endocrinologist Freddy Goldeberg Elieschewtz, one of the founders of the Association of Clinical Research of Brazil (APCB).

In phase II, in which the drug is tested in a small group of sick people, there is yet another legal barrier. By law, the administration of drugs that do not have the approval of Anvisa is not allowed, which would legally prevent the tests. Another legal point that hinders the creation of genuinely Brazilian drugs concerns patent law. Brazil has a rich biodiversity, which could generate new drugs, however, the intellectual property law does not allow discoveries from nature to be patented.

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Industry “copies” foreign discoveries

Considering all the legal, technological and financial barriers that hinder the research and development of new drugs in Brazil, the Brazilian pharmaceutical industry ended up becoming a great “copier” of existing drugs. According to the Association of National Pharmaceutical Laboratories (Alanac), the country currently has about 300 companies with national capital operating mainly in the market for similar and generic drugs. According to the organization, they dominate at least 40% of the Brazilian pharmaceutical market share. “There are companies that have innovative medicines that have been researched, developed and launched in Brazil, but these numbers are still timid due to the large investment required for the development of new products”, says Alanac's technical regulatory coordinator, Douglas Duarte.

The president of the Consultative Council of the Association of the Pharmaceutical Research Industry (Interfarma), Jorge Raimundo, recognizes that national companies cannot compete with multinationals, but believes that Brazil has other possibilities. For him, the national industry can invest not only in the production of generics, but in the improvement of the existing formulas. “Instead of developing a new molecule, we can work with incremental innovations, that is, modify the formula of an existing drug to make it better. Develop a second use for a medicine that is already on the market or work on the formula to make the product more stable to variations in climate, for example. Most drugs are researched in countries with cold climates, here we can adapt this formula so that it can better resist heat ”, he explains. According to him, Brazil also has technology to research in areas such as genetic engineering, stem cells and biotechnology. Likewise, a market that is still little explored by multinationals concerns so-called neglected diseases, such as malaria and Chagas disease. The big international pharmaceutical companies in general are not interested in researching drugs for these diseases, since the financial return of these products would not compensate for the investment.

Multicentric

Bureaucracy also makes multicenter clinical trials difficult.

The Hospital de Clínicas (HC) of the Federal University of Paraná is one of the Brazilian research centers that participate in this research modality. According to the coordinator of the Research Ethics Committee of the HC, Renato Tâmbara, about 30 to 40 projects are analyzed per month. Of these, approximately 65% ​​are from multicenter studies.

The intensive care service, for example, has participated in about ten such trials in the past decade. “We are currently carrying out a study to test antibiotics against multi-resistant bacteria”, says the head of the service and professor of medical clinic at UFPR, Álvaro Rea-Neto.

In the rheumatology service, about ten other international multicentre clinical trials are testing drugs for diseases such as rheumatoid arthritis, osteoporosis, lupus and arthrosis.

Although the majority are phase II or III studies, the service is participating in a phase I study, which is quite rare in Brazil. It is a new drug for the treatment of lupus. “In the last 30 years, we have made almost no progress in this area and we continue to use high-dose corticosteroids and some immunosuppressants such as cyclophosphamide, which has serious side effects such as ovarian atrophy. This would be the first biological drug orally to treat the disease and with a mechanism of action completely different from the others ”, says the rheumatologist and head of the service, Sebastião Radominski. According to the doctor, if approved, the drug may make life easier for patients who will no longer have to go to the hospital for an infusion and will be a new option for those who do not respond to the drugs available today.

Delay

In addition to the legal and technological difficulties, the delay in approving research by the National Research Ethics Commission (Conep) is pointed out by researchers as another major impediment. As a rule, the analysis of a study request should be done within 60 days. In practice, however, this takes much more.

The HC pediatric allergy service has been trying to approve a phase II study for a year and a half. These are tests for a vaccine against respiratory infections in children. “As the study involves manipulating genetically modified viruses, we had to adapt to biosafety standards. The study is expected to last six months. In other countries, the tests were even concluded and we are still waiting to start here ”, says the pulmonologist and head of the service, Nelson Rosário.

If, on the one hand, the rigid legislation in Brazil gives security and credibility to the studies done here, on the other hand it ends up making the labs, tired of waiting, end up giving up conducting research in Brazilian centers and looking for other countries where the process is more agile. “I lose the research center, the doctor, the volunteer, in short, everyone, because we will not have had the chance to deal with this drug, see how it works. We will receive it promptly, without knowing how it acts in our population ”, defends Elieschewtz.

Studies give patients a new chance

Conducting multicenter clinical trials in the country is important because it offers doctors and researchers the opportunity to be in contact with international research protocols. This means that the centers are obliged to update themselves and train the professionals involved. In addition, scientists and the institution also have the possibility to participate as co-authors in the publication of works when they appear in international medical journals. Seen from the patients' side, the research represents the chance of treatment with a state-of-the-art medication, even after the end of the study. “A patient who no longer responds to available treatments and who depends on the public system would hardly have access to these medications. Participating in such a study, in addition to receiving the medicine, he has full access to exams and intense medical monitoring ”, emphasizes pulmonologist Nelson Rosário, from Hospital de Clínicas (HC), Federal University of Paraná.

Secretary Mariana Polinarski Souza, 62, participates as a volunteer in a study that tests a new medication against rheumatoid arthritis, at HC. Five years ago she discovered she had the disease. There were several attempts with different drugs and no improvement. “I got to a point where I couldn't do anything by myself anymore. I couldn't shower, go to the bathroom, get dressed. I couldn't even put on a shoe by myself, ”she says. Six months ago, she volunteered for the study conducted at the hospital. “Now I feel better, I started doing things that I didn't do. If it weren't for research, I would still be suffering a lot ”, he says.