Promise and prejudice : why medicines from plants, animals and fungi should be further researched

Abstract

Innovation in medicines from organisms is limited because intellectual property law in most jurisdictions is such that naturally occurring entities cannot be patented except in specific circumstances. Given the high cost of researching medicines to produce the evidence needed to support applications to regulators to market products as medicines firms are unlikely to invest in areas where rewards are doubtful. Further factors contribute to a dearth of research in medicines from organisms. Historical tensions between the medical profession and practitioners of traditional, complementary and alternative medicine and a preference for synthesizing new compounds on the part of scientists also likely contribute to the lack of research, infrastructure and scientific training to enable such research. Concerns about sustainability of supplies of raw materials to manufacture medicines and biodiversity, which is threatened by overharvesting in wild areas and unsustainable cultivation practices, also act as disincentives to researching organisms as medicines. Intellectual property concerns surrounding the traditional knowledge of indigenous and ancient cultures are also largely unresolved. Current approaches to pharmaceutical research that identify physiological targets in the body and then develop medicines to act on them, is another reason why organisms are usually overlooked as drug leads. Natural compounds and whole medicines from organisms have multiple actions in the human body that synthetic compounds do not. Early research and observational evidence from long term use of organism-based medicines has shown great untapped potential for the development of effective treatments for the global burden of disease. Organism-derived medicines may also be safer than many synthetic compounds, perhaps as a result of adaptation to the human mammalian environment through long term interaction in ecosystems. The imperative to conduct research in this area should have been obvious given the therapeutic success of medicines from organisms such as penicillin and artemisinin. The majority of people in the world use traditional medicines composed of organisms. In the interests of non-maleficence these medicines should be researched to confirm their safety. Respect for autonomy would be supported by the presence of more effective treatment choices and stronger evidence upon which to make recommendations and decisions about health care. Beneficence, looked at from a population perspective, would suggest such medicines should be researched for their potential to yield therapies and prophylactics for infectious disease. More treatment choices might also mean that the development of pathogen resistance is slowed. Justice and human rights would be supported if organisms in local environments formed the basis of sustainable cultivation and medicines industries in the developing world. It is likely that a range of mechanisms will be necessary to optimize the development of medicines from organisms. Push mechanisms, including funding provided by governments or sponsors might offer an initial stimulus. Pull mechanisms that do not rely on patents to reward innovation may also be valuable in incentivizing research on organisms. Re-examination of regulatory structures, strengthening of health systems, ensuring sustainable cultivation practices and resolving traditional knowledge issues will also likely be necessary. Show more