To search for medicines, to boost science, to preserve nature, to strengthen industrial competition, to strengthen academic educational programs, to improve health care, to correct misuse, and to support positive interactions with indigenous populations: These have been the goals of the Brazilian autochthonic medicine programs for the past 20 years.
The potential for autochthonic medicinal research in Brazil is unrivaled for many reasons:
Exuberant biodiversity: five distinct ecosystems under constant stress: the Amazonian rain forest, the periodically flooded pantanal inland, the dry but colorful and folkloric northeast, the temperate Atlantic forest and the midland short-grown cerrado. Brazil is one of the few countries in the world with unexplored frontiers.
Folk information: the rich caboclo culture, a blend of the coastal native people's knowledge of the country´s ecosystems, with Portuguese, French, Dutch, and strong African influences in the northeast and with the Germans, Italians, Japanese, and other peoples in the south.
Social support: the growing conscience, mainly among youngsters, of the intrinsic value of biodiversity. These values are praised internationally and supported by national government programs, nongovernmental organizations, and research funders dedicated to the scientific evaluation and rational preservation of natural resources.
Motivation: the force represented by 80 million teenagers and pre-teens (48% of the total population) pushing biodiversity policies.
Economical value: the robust national pharmaceutical industry, the strong pharmaceutical sales, and the growing competition for new leads and new markets.
Expertise: the large number of nationally and internationally trained young postdoc fellows.
Regulatory: government policies regulate scientific exchange and restrict the access and the exchange of genetic resources, thereby cooperative research is encouraged among Brazilians and with invited scientists from abroad.
Social benefits: above all, the conscious scientific motivation to develop autochthonic medicinal resources may help break through standard lines of thinking and behavior to promote an equitable distribution of work, profit, and social benefits.
Medicines derived from plants were widely used as remedies in Brazil until the end of World War II, when these were progressively replaced by synthetic compounds. Although easily produced in scale and quality-controlled by fast chemical analysis, synthetics do have their downside. Ironically, we are coming to realize that medicines developed using these modern techniques lack the structural chemical diversity necessary for pharmacological innovation, while medicines obtained from natural sources are often chemically unique.
Twenty years ago, to decrease the heavy dependence on foreign supply of pharmaceuticals, the Ministry of Health launched the largest program ever seen in Brazil to boost the internal production of medicines. Support of synthetic chemical production has stimulated a boom of ?me too? compounds. At the same time, investments in bioprospecting have yielded a few medicines but long-lasting benefits. Bioprospecting targets commonly used folk phytoremedies for pharmacological and chemical studies. This has in turn spurred research on two fronts: standardizing the plant material to allow its use in natura and validating its medicinal efficacy and safety. Both strategies have been successful.
Sadly, simply standardizing production and harvesting of plant material has been sufficient for local and transnational companies to increase the consumption of unregulated phytoremedies to never-before-seen levels. MDs, PharmDs, and even fewer PhDs occupy only a small number of scientific positions in these large production plants. Fortunately, the scientific evaluation of medicinal plants was pursued in parallel. Albeit slow to produce marketable pharmaceuticals, evaluation programs have been very effective in creating a necessary research infrastructure. Students had to be trained, national standards had to be established, and academia had to be prepared to take over preclinical and clinical research in the field.
Bioprospecting in Brazil: Where the Money Comes From
Currently, several federal funding agencies support Brazilian academic scientists and the pharmaceutical industry in the development of new medicines:
Funds individual projects to scientists interested in performing the experiments necessary for phytoremedies already in the market to pass legal requirements of efficacy and safety.
Promotes joint ventures between industries and universities to improve science and technology in many areas, including biodiversity.
The Brazilian Association for the Sustainable Use of Amazonia Biodiversity is a national research program sponsoring research on the tropical rain forest.
The State of São Paulo Research Foundation sponsors individual and group projects in many areas. A special program (BIOTA-FAPESP) funds investigations of state biodiversity resources, mainly those of the Atlantic forest.
A few pharmacy schools have incorporated the teaching of natural pharmaceutical development into the core curriculum. Medical schools have resisted the introduction of a specific phytotherapy curriculum, preferring to wait for more data on efficacy and safety. It is common knowledge in clinical practice however, that phytomedicines can match conventional treatments.
Currently, the Brazilian scientific community is divided on the best strategy for developing new medicines. The majority of academic research projects explore the natural resources of Brazilian biodiversity using a classical approach based on biological standardization and bioguided chemical purification. Those motivated to be internationally known scientists invest in the random discovery of new therapeutic entities. Combinatorial chemistry, biotechnology, and high-throughput screening of natural molecules are specialized areas that young scientists are encouraged to develop through international collaborations.
International companies invest heavily in local third-phase clinical trials but do not invest in basic research in Brazilian facilities. This has a negative impact on the local society. Joint ventures between international and Brazilian companies, or investment of seed-money in "secret" academic projects, are reported by the Brazilian media as attempts of ?international piracy.? This annoying misunderstanding will likely end as scientific partnerships become more common. More promising changes are occurring. For example, the best national pharmaceutical companies are starting to invest in the validation of plant-derived medicines in an attempt to lay claim to new medicines and compete with the conventional imported compounds, which make up over 70% of the Brazilian market.
In 1995, Brazilian pharmaceutical companies were legally required to document pharmacological efficacy and safety as well as the predictive toxicology of phytoremedies just as for as any other pharmaceutical product. The international patent law protecting new pharmaceutical entities was internally recognized in 1997, ending unauthorized copying and protecting research investments. The combination of scientific advances and economic improvement has had a marked impact on the Brazilian pharmaceutical market, which has increased 10-fold in the past 20 years and now ranks fifth in the world, with annual sales of about $12 billion.
The statement that research on medicines of the rain forest is cost effective contrasts with the paucity of medicines that actually come to market. It is close to impossible to predict the type of compound to search for, the plant species to collect, or the special ecosystem to explore. Isn?t it true magic to hit the jackpot with such a low probability of success? Perhaps it is better to ask whether the discovery of new medicinal entities should be the most important benefit of bioprospecting.
Antonio Jose Lapa is a professor of pharmacology at Escola Paulista de Medicina/Universidade Federal de São Paulo in São Paulo, Brazil. You may contact him at firstname.lastname@example.org.