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Human genome efforts in Japan.

Some project-oriented biosciences have been promoted cooperatively by three governmental agencies in Japan: the Ministry of Education, Science and Culture, the Ministry of Health and Welfare, and the Science and Technology Agency. All three agencies have increased their budgetary requests for human genome analyses for FY 1991. The Panel on Life Sciences (chaired by Dr. W. Mori, former president of the University of Tokyo) of the Science and Technology Council of Japan which is chaired by the Prime Minister has decided to organize a working group to suggest how best to coordinate efforts in human genome analyses in Japan. The genome project was initially promoted by the Science and Technology Agency through a program for the design and construction of automated machines for DNA sequencing. Work is ongoing at the Institute of Physical and Chemical Research to integrate, by system engineering, instruments that can separate DNA fragments, perform plaque selection, carry out dideoxy reaction, and read the resulting DNA sequence. However, scientists now realize the enormity of the tasks of compiling DNA sequence data and of mapping the genes and fragments obtained, and efforts are being made to solve these problems. Academic societies have organized symposia to promote general interest in this subject. The most important way for Japan to contribute to research on human genome analyses, however, may be in the evaluation of supporting mechanisms (technical assistance and research resources) and in the recognition and preparation of the transition of biology to a big science approach.

Base Sequence↗

Influencing science policy in Japan.

The administrative structure for the funding of science and technology in Japan is now going through a marked change. The newly formed Council for Science and Technology Policy (CSTP) has been given great powers - but how, in particular, is the funding policy being addressed by the new administrative structure, and how can scientists influence science policy in Japan?

Financing, Organized↗

Japan's ethical guidelines for epidemiologic research: a history of their development.

During the latter half of the 1990s, Japanese healthcare professionals and policy-makers recognized the value of an "evidence-based" approach. At the same time, an increased social awareness of the need to protect research participants and personal information began to appear. Recognition of an evidence-based approach further promoted epidemiologic research while regulations on personal information protection imposed certain limitations on this same research. In April 2000, as a solution to this conflict, a working group funded by Japan's Ministry of Health and Welfare (MHW; currently the Ministry of Health, Labour and Welfare: MHLW) proposed a first draft of ethical guidelines for epidemiologic research. Over the next two years, the collection of domestic and foreign data by working groups and governmental ad hoc committees, questions raised by the mass media, and public statements made by organizations, such as the Science Council of Japan and the Japan Epidemiologic Association (JEA), led to a collaborative effort between the Ministry of Education, Culture, Sports, Science and Technology and the MHLW. This effort led to the creation of the Ethical Guidelines for Epidemiologic Research in June 2002, which was revised in 2004. Furthermore, JEA also announced the Ethical Guidelines for Conducting of Epidemiologic Research in October 2002. While the development of these ethical guidelines has been a challenge for Japanese epidemiologists, it has also allowed the epidemiologic community to understand their role in society. This review aims to provide insight into the interaction between the epidemiologic community and society by assessing historically the developmental process of these ethical guidelines.

Epidemiology↗

[Reform of Japan's NTP and its technical perspectives].

The 1951 Tuberculosis Control Law of Japan is now faced with tremendous changes that have occurred during the last 50 years in tuberculosis epidemiology and in the environment in tuberculosis control implementation. The law is also challenged with the shift of the paradigm for the National Tuberculosis (TB) Programme. In order to respond properly to these changes, the Tuberculosis Panel of the Health Science Council of the Ministry of Health, Labor and Welfare submitted its report for the amendment of the law in March 2002. Based on this report, a new Tuberculosis Control Law was passed in Parliament last June, and related decrees of the Cabinet and the Ministry are now being revised in preparation for it's enactment in April 2005. In this special lecture, the main points and framework of the revisions were discussed with the perspective of the development of new technical innovations relevant to each area of the revised TB control legislation. 1. Case detection. There will be a shift from the current "indiscriminate" screening scheme to a selective one regarding periodic mass health examination. Only subjects aged 65 or older will be eligible for the screening, supplemented with selected occupational groups who are considered to be at a higher risk of TB, or may be a danger to others if they develop TB, such as health-care providers and school teachers. In addition, local autonomies are responsible for offering screening to the socio-economic high-risk populations, such as homeless people, slum residents, day laborers, and/or workers in small businesses. This means that the efforts of the autonomies are critical for the new system to be effective. The extra-ordinary examination will be limited to only the patient's contacts, and will be mandatory for those contacts so they cannot refuse to be examined by the Health Center. The public services used in the contact investigations will be greatly facilitated by such new technologies as DNA fingerprinting of TB bacilli and a new diagnostic of TB infection using whole-blood interferon-gamma determination (QuantiFERON). The quality of clinical diagnosis and monitoring of treatment should also be improved by introducing an external quality assurance system of commercial laboratory services. 2. Chemoprophylaxis. Although not explicitly defined in the new legislation, the expansion and improvement of chemoprophylaxis to cover anyone with any risk of clinical development of TB would have a tremendous effect in Japan, especially since 90% of patients who developed TB were infected tens of years ago. These technical innovations in diagnosis of TB infection will be very helpful. Development of new drug regimens for the preventive treatment is also badly needed. 3. Immunization. Prior to the amendment of the Law, the BCG vaccination of students entering primary and junior high schools has been already abandoned. In order to encourage the early primary vaccination for infants, the new Law will adopt the direct vaccination scheme in which babies will be given the BCG vaccine without tuberculin testing. This program will be implemented safely, only if it is given to young babies, e.g., less than one year old, as defined by the decree. It is essential to maintain the high level of vaccination coverage under the new program. The autonomy may encounter difficulty mobilizing client babies shortly after their birth (only one year, as compared with the current four years). To avoid the possible, though very rare, adverse health effects due to the vaccination of infected babies, careful questioning should be conducted regarding the risk of exposure to infection prior to vaccination. A ready course of treatment and examinations for abnormal reactions after vaccination (Koch's phenomenon) is also warranted. 4. Treatment and patient care: The revised Law clearly states the governmental responsibility for treating TB patients in close cooperation with a doctor. This is an important legal basis for the expansion of the DOTS Japan version. While the development of new anti-tuberculosis drugs will be realized in the near future, Japan still has to overcome the issue of improper practice of treatment, as well as the government's slow process for approving new drugs to be used for multi-drug resistant TB and non-tuberculous mycobacterioses. 5. Prefectural TB Control Plan: In order to resolve the problems specific to the respective prefectures in terms of epidemiological parameters or available resources, the new Law requests every prefecture to develop its own TB control plan. In order for the new TB Control Law to be effective, strong government commitment supported by technological innovation is mandatory. It is for that reason that the Japanese Society of Tuberculosis should aggressively join the global movement to stop TB along with the general public of Japan.

Antitubercular Agents↗

Consensus document on European brain research.

Brain disease psychiatric and neurologic disease combined represents a considerable social and economic burden in Europe. Data collected by the World Health Organization (WHO) suggest that brain diseases are responsible for 35% of Europe's total disease burden. An analysis of all health economic studies of brain diseases in Europe, published by the European Brain Council (EBC) in June 2005, estimated the total cost of brain disease in Europe in 2004 to be Euro 386 billion. That burden is set to grow, mainly due to the fact that the European population is ageing. Investment in brain sciences does not match that burden now, let alone in the future. Brain research received only 8% of the life science budget in the European Commission's Fifth Framework Programme, which represents less than 0.01% of the annual cost of brain disorders for that period. Over the last decade, Europe has been losing ground to the USA and Japan in terms of both basic and clinical research. Many of Europe's young researchers are taking up posts in the USA and staying there. Big pharmaceutical companies are fleeing Europe for the USA, taking their drug development programmes with them. Research in the brain sciences now holds the promise of therapies that halt and even reverse neurodegeneration, of better diagnostic tools, neural prostheses for the paralysed and drugs for depression and anxiety that are tailored to the individual, thereby eliminating or reducing side effects. Our growing understanding of the normal brain could lead to better prevention of brain disease and to more effective teaching methods. The need for innovative treatments has never been greater, and Europe boasts clusters of excellent researchers in biotechnology who could collaborate with brain scientists and the pharmaceutical industry to realise this promise. But if Europe is to seize these opportunities and meet the challenge of brain disease, it needs to go forward on the basis of greater collaboration between countries, greater collaboration between industry, academia and patient organisations, and increased investment in the brain sciences. The EBC was formed in 2002 to bring together scientists, clinicians, the pharmaceutical industry, charities and patient organisations from all over Europe to campaign for these goals. It takes a novel, bottom-up approach to research policy, and in developing this consensus document, it aims to promote a greater and more focused effort in this area, to improve public understanding of the brain sciences and above all, to support brain research as a priority under the European Commission's Seventh Framework Programme (FP7, 2007-2013). The research programme outlined here was first conceived by the EBC board. An outline was sent to all member organisations and a number of individual experts for comments. Following that, a table of contents was developed. The 45 research themes were written by groups of experts from across Europe who represent a wide range of disciplines. Each one contains a proposal for future research on a specific brain-related theme which the EBC believes could form the basis of one or more integrated projects or strategic targeted research projects (STREP) funded under FP7. The EBC has deliberately focused on the major diseases and then described the basic research needed to understand and treat or perhaps even cure those diseases. The programme is therefore constructed "from man to molecule" and not the other way round, with equal importance attached to basic and clinical research. The EBC suggests that each of the proposed integrated projects or STREP should be awarded a budget in the order of Euro 10 to 15 million. In addition, brain research should be treated as an important element of many other parts of FP7, such as the European Research Council and research programmes on information technology and the causes of violence. Any research programme that concerns human behaviour should, by definition, take account of brain research. The EBC envisages that the priority for brain research it proposes at the European level will translate into higher priority for brain research at the national level, and this document may also serve as a starting point for the development of national consensus programmes. It seems likely that consensus conferences on brain research in Europe may further develop the themes and ideas discussed here. An EBC task force may also be established to further the consensus process. In general, increasing funding in the brain sciences would bring enormous economic returns by lightening the burden on healthcare systems and increasing the productivity of affected individuals-and might easily pay for itself. The human and social returns of such an investment are inestimable. And the time to act is now.

Biomedical Research↗