Is orphan drug status beneficial to tropical disease control? Comparison of the American and future European orphan drug acts.
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OBJECTIVES To quantify past outcomes of tropical pharmacology research and development (R & D) and to assess past benefits of the American orphan drug act and potential benefits of the future European orphan drug regulation on tropical diseases. METHODS: This paper presents two analyses: a 1983-97 retrospective study of the United States Orphan Drug Act concerning rare diseases and a prospective study of the European Proposal for a Regulation Concerning Orphan Drugs and its possible impact on tropical diseases. RESULTS: Different programmes have in the past tried to stimulate R & D in this area, but results remain limited. Of 1450 new chemical entities marketed between 1972 and 1997, 13 were specifically for tropical diseases and considered as essential drugs. Between 1983 & 1997, the US Orphan Drug Act approved 837 drugs and marketing of 152 new molecular entities (NMEs). Three NMEs have been designated for malaria and human African trypanosomiasis. Seven others, already commonly used in tropical diseases, received either orphan designation or an orphan approval for another indication. Pharmaceutical companies benefit from the US framework only when the US market exclusivity clause was applicable. Future European orphan drug regulation appears to be similar to the US Orphan Drug Act. CONCLUSION The orphan drug programmes relating to rare diseases have met with some success. Considering tropical diseases rare diseases seems inadequate to boost pharmaceutical R & D. However, some provisions of the European text may be relevant to tropical diseases, admitting the need for a more specific rule for evaluations of this kind of drug and recognizing the existence of 'diseases of exception'. (+info)
Threats to global health and survival: the growing crises of tropical infectious diseases--our "unfinished agenda".
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Health, one of our most unassailable human values, transcends all geographic, political, and cultural boundaries. The health problems of the rapidly growing 80% of the world's population that live in the tropical developing countries of Asia, Africa, and Latin America pose major threats to industrialized as well as developing regions. These threats can be divided into three areas, or three "E"s: (1) emerging, reemerging, and antimicrobial-resistant infections; (2) exploding populations without improved health; and (3) erosion of our humanity or leadership if we ignore the growing health problems of the poor. Our assessment of current trends in global population distribution and resource consumption; DALY calculations, causes, and distribution of global mortality and morbidity; and the misperceptions about and maldistribution of resources for health point to the critical importance of addressing tropical infectious diseases and global health for preservation of democracy and civilization as we know it. (+info)
The production and preliminary investigation of Burulin, a new skin test reagent for Mycobacterium ulcerans infection.
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The preparation of a skin test antigen from Mycobacterium ulcerans by ultrasonic disintegration and filtration is described. The reagent, called Burulin, was tested in Africa in normal school children, and in patients with leprosy, tuberculosis or M. ulcerans disease. Those with tuberculosis or M. ulcerans disease were simultaneously tested with Tuberculin PPD. Burulin was found to be highly specific for patients in the reactive stage of M. ulcerans disease, and there was no cross-reaction in patients with other mycobacterioses. On the other hand, the majority of patients with M. ulcerans disease reacting to Burulin also produce positive reactions to Tuberculin PPD. (+info)
The Seamen's Hospital Society: a progenitor of the tropical institutions.
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1999 marks the centenary of the two major British Schools of Tropical Medicine, founded in London and Liverpool, respectively. The origin(s) of the former clearly lies in the Seamen's Hospital Society, which dates from 1821. It seems likely that the foundation of this school (with Government support) also acted as a catalyst for the school at Liverpool, which in fact opened its doors a few months before that in London. (+info)
The American Society of Tropical Medicine and Hygiene initiative to stimulate educational programs to enhance medical expertise in tropical diseases.
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More than a decade ago, at a time when current and emerging tropical diseases posed growing threats to the United States, expert panels convened by the Institute of Medicine of the U.S. National Academy of Sciences concluded that medical expertise within the United States competent to address diseases of the tropics had declined. Recognizing a national need to encourage and enhance such, The American Society of Tropical Medicine and Hygiene developed a program to stimulate new postgraduate medical education in diseases of the tropics. The Society formally requested academic institutions within the United States and Canada to propose new postgraduate programs. To assure the quality of these new curricular offerings, the Society developed an outline of key areas of competency and agreed to offer an examination that would grant physicians a Certificate of Knowledge in Clinical Tropical Medicine and Travelers Health. The certifying examination was to be an integral component of a program to stimulate academic institutions to provide instructional programs in tropical diseases and to encourage physicians to become trained, evaluated, and recognized for their knowledge of clinical tropical diseases and travelers' health. The Society's initiative to stimulate educational programs in tropical medicine is reviewed. (+info)
Tropical and exotic infections. Proceedings of the 5th Liverpool Tropical School Bayer Symposium on Microbial Diseases. 14 February 1998.
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In summary, MDR strains of S. typhi are both epidemic and endemic in many countries in Asia and MDR S. paratyphi A has recently emerged in Pakistan. Multiple clones may be present in a given area at any time. Fluoroquinolones and third generation cephalosporins have been used widely over the past decade to treat MDR strains. The clinical superiority of fluoroquinolones is now threatened by the rapid emergence of chromosomally mediated resistance and cephalosporin resistance is also being reported. Whether these problems can be overcome by the use of newer fluoroquinolones or cephalosporins remains to be seen. Meanwhile, furazolidone and azithromycin deserve further trials, and clinical and molecular surveillance of resistance patterns remains essential. (+info)
Infectious and tropical diseases in Oman: a review.
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Oman is generally hot and dry, but the Salalah region in southern Dhofar province is relatively cool and rainy during the summer monsoon, and has a distinctive pattern of infection. Important, notifiable infections in Oman include tuberculosis, brucellosis (endemic in Dhofar), acute gastroenteritis, and viral hepatitis: 4.9% of the adults are seropositive for hepatitis B surface antigen and approximately 1.2% for hepatitis C virus. Infection with human immunodeficiency virus is uncommon, and leprosy, rabies, and Crimean-Congo hemorrhagic fever are rare. Between 1990 and 1998, the incidence of malaria, (>70% due to Plasmodium falciparum) decreased from 32,700 to 882 cases. Cutaneous and visceral leishmaniasis (caused by Leishmania tropica and L. infantum, respectively) and Bancroftian filariasis occur sporadically. Intestinal parasitism ranges from 17% to 42% in different populations. A solitary focus of schistosomiasis mansoni in Dhofar has been eradicated. There are major programs for the elimination of tuberculosis, leprosy, and malaria, and to control brucellosis, leishmaniasis, sexually transmitted diseases, trachoma, acute respiratory infection in children, and diarrheal diseases. The Expanded Program on Immunization was introduced in 1981: diphtheria, neonatal tetanus, and probably poliomyelitis have been eliminated. (+info)
An Advisory Committee Statement (ACS). Committee to Advise on Tropical Medicine and Travel (CATMAT). Statement on meningococcal vaccination for travellers.
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The Committee to Advise on Tropical Medicine and Travel (CATMAT) provides Health Canada with ongoing and timely medical, scientific, and public-health advice relating to tropical infectious disease and health risks associated with international travel. Health Canada acknowledges that the advice and recommendations set out in this statement are based upon the best current available scientific knowledge and medical practices, and is disseminating this document for information purposes to both travellers and the medical community caring for travellers. Persons administering or using drugs, vaccines, or other products should also be aware of the contents of the product monograph(s) or other similarly approved standards or instructions for use. Recommendations for use and other information set out herein may differ from that set out in the product monograph(s) or other similarly approved standards or instructions for use by the licensed manufacturer(s). Manufacturers have sought approval and provided evidence as to the safety and efficacy of their products only when used in accordance with the product monographs or other similarly approved standards or instructions for use. (+info)