The Human Genome Project after a decade: policy issues.

The Human Genome Project began a decade ago, its early momentum fueled by two reports. A report from the National Research Council (NRC) in February 1998 endorsed the project and provided the basis for the first joint plan by the National Institutes of Health (NIH) and the Department of Energy (DOE). A report from the Office of Technology Assessment (OTA) in April 1988, provided Congress with a means to assess the roles of NIH and DOE. Both reports highlighted the importance of genomics and emphasized the need for a concerted research program. The committees did not predict the large investment of private funds or the extensive patenting of sequences, and they underestimated the rate of progress. Overall, though, the consensus-building provided by the committees helped to set the blueprint for one of the great success stories in modern biology.

Looking at genes in the workplace.

KIE: The Office of Technology Assessment recently testified at a congressional hearing that many corporations are considering genetic screening of employees. Biochemical genetic screening of "susceptible" workers is aimed at identifying individuals unsuitable for specific jobs, and cytogenic monitoring involves the testing of groups of workers for chromosome aberrations that might occur as a result of exposure to chemicals. The apparent surge of interest in such testing requires that several legal, ethical, and policy issues be addressed, including the potential for discrimination, the misuse of screening as an alternative to cleaning up the workplace, the predictive capability of the tests, and the necessity for the development of guidelines for screening programs.^ieng

A pivotal year for lab animal welfare.

KIE: Developments in the U.S. during 1985 related to laboratory animal welfare are discussed. The enactment of amendments to the Animal Welfare Act of 1966 and revisions to the Public Health Service's animal care guidelines are described as major federal moves to tighten standards and to locate responsibility for proper animal care at the institutional level. These regulatory changes will have a significant economic impact on the cost of doing research, but are generally accepted by the scientific community as necessary. Although moderate animal welfare groups see signs of progress, there is a growing number of activists who see recent policy developments as only a step toward the real goal of total elimination of the use of animals in research. It is apparent that the combination of political pressure, financial stringency, and better experimental methodologies will result in a continued reduction in laboratory animal use.^ieng

Another round in Rifkin versus gene splicing.

KIE: Pending approval by the National Institutes of Health and the Food and Drug Administration, the first authorized experiments in human gene therapy are expected to begin sometime in 1985. Anticipating approval, the congressional Office of Technology Assessment (OTA), at the request of then Representative Albert Gore, Jr. (D-Tenn), compiled a report on the scientific and ethical issues involved. OTA found no unique ethical obstacles to somatic cell therapy if conducted safely and with a reasonable expectation of efficacy. It reached no agreement concerning the necessity, feasibility, or ethical acceptability of germline therapy, and recommended further evaluation and public discussion.^ieng

Gene therapy: research in public.

KIE: Culliton discusses what she terms the "unprecedented" public scrutiny to which the technology of gene therapy and its potential application in humans have been subjected. She summarizes the federal government's interest in this area, ranging from the Office of Technology Assessment's report, Human Gene Therapy, to the creation of the Working Group on Human Gene Therapy. The latter, a subcommittee of the National Institutes of Health's Recombinant DNA Advisory Committee, released a list of "points to consider" by researchers planning to design and submit protocols to NIH for gene therapy research in humans. Culliton notes that some of the questions that the working group asks potential researchers "go beyond the usual" to address controversial areas of gene therapy such as primate studies, public health considerations, public relations, patents, and eugenics.^ieng

New bioethics panel under consideration.

KIE: Proposals for a bioethics panel to replace the defunct President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research have been made in the Senate by Edward Kennedy (D-Mass.) and Jeremiah Denton (R-Ala.). Denton favors a panel within the Office of Technology Assessment (OTA), while Kennedy favors sponsorship by the Institute of Medicine. Congress may find the OTA suggestion more attractive because of greater congressional control over the panel's agenda and recommendations.^ieng

Health technology assessment (HTA): a brief introduction of history and the current status in the field of cardiology under the economic crisis.

In a time of economic recession health technology assessment is an established aid in decision making in many countries in order to identify cost-containment policy options. Moreover, as the volume, complexity, and cost of new medical technology increases, the need for evaluating benefits, risks and costs becomes increasingly important. In recent years there has been a proliferation of health technology assessment initiatives internationally, aimed in introducing rationality in the decision-making process, informing reimbursement, providing clinical guidance on the use of medical technologies across the world in an evidence-based decision-making environment and in pricing decisions.

Human gene therapy and congress.

Congress was the scene of conspicuous debate about human gene therapy during the 1980s. Congressional interest was sparked primarily by concerns about germ-line gene therapy expressed by clerics and public interest groups. The initial debate was provoked by Martin Cline's misadventures in 1980 and rekindled in 1983 by congressional resolution against germ-line intervention sponsored by Senator Mark Hatfield. The first hearing on gene therapy was held upon the release of the President's Commission report Splicing Life, in November, 1982, before a House subcommittee chaired by Congressman Albert Gore, Jr. Representative Gore later requested a report on gene therapy, which was released by the Office of Technology Assessment in December, 1984. He also sponsored the legislation that established the Biomedical Ethics Board and Biomedical Ethics Advisory Committee, Congress's abortive attempt to reestablish a federal bioethics commission. Implications of advances in human genetics, including gene therapy, were to be among the first topics addressed. Congress passed no substantive legislation affecting gene therapy research or clinical trials, but served principally as a national theater for debate. If and when germ-line gene therapy is contemplated, Congress will be faced with difficult choices, but will likely take no action to block trials that appear safe and are intended to produce clinical benefit for particular individuals.

Total parenteral nutrition and tube feeding for elderly patients: findings of an OTA study.

A 1987 report by the US Office of Technology Assessment (OTA), Life-Sustaining Technologies and the Elderly discusses current utilization of tube feeding and total parenteral nutrition (TPN) for elderly people and the related issues of patient access to treatment, decision making practices, and quality of care. Factors that limit access for some elderly patients include negative attitudes of some health professionals about whether elderly people can benefit from tube feeding and TPN, lack of adequate nutritional standards for the elderly and lack of staff in some treatment settings who are trained and have enough time to assess nutritional status in elderly patients, and payment problems. Public controversy about life-sustaining technologies for elderly people now focuses on decisions about withholding or withdrawal of tube feeding, but debate about the legal and ethical issues involved in these decisions tends to obscure the relevant clinical considerations. Research issues and clinical practice concerns related to decision making and quality of care for elderly patients on tube feeding and TPN are discussed.

Screening policy for cystic fibrosis: the role of evidence.

Setting priorities about medical services, including genetic testing services, often occurs in an extemporaneous fashion. Normative assumptions may not be examined critically, although doing so is a necessary component of making health policy decisions about clinical practice. The normative dimension to health policy questions suggests a need for greater public participation in the development of clinical practice guidelines. The experiences of newborn screening and carrier screening for cystic fibrosis in the United States can be examined within the framework of two models of health policy development that help explain the role in health policy development of normative assumptions and public participation. Specifically, this paper focuses on assumptions about what counts as sufficient empirical data to make health policy decisions.

Genetic witness: forensic uses of DNA tests.

"Genetic Witness: Forensic Uses of DNA Tests" summarizes the findings of a 204-page report by the U.S. Congressional Office of Technology Assessment (OTA). It reviews the DNA techniques used in criminal casework, evaluates the validity and reliability of the technologies, examines issues of quality assurance, reviews the legal implications of the use of DNA tests by U.S. courts, and analyzes the privacy implications of forensic DNA tests and computer databanks. It presents a range of actions that could be taken by the U.S. Congress to address five policy issues: standards for forensic uses of DNA typing; funding of crime laboratories, forensic personnel training, and forensic research; the advisability of establishing computer databanks of DNA test results; and privacy considerations of collecting, using, and storing DNA data or samples.