A call to restructure the drug development process: Government over-regulation and non-innovative late stage (Phase III) clinical trials are major obstacles to advances in health care

The history of drug/vaccine development has included major advances guided primarily by risk/benefit analyses concerning the innovative agent, not by evidence-based clinical trials (Phase I–IV). Because the approval for new drugs is hindered under the present process, the system requires restructuring. The Phase I/II study period should be more flexible, using the “environment of knowledge” about the new agent, plus risk/benefit assessments. Phase III, as presently constructed, does not add new adverse events data, it provides a narrower profile of drug efficacy than properly done Phase II studies, and placebo-controlled trials continue to raise unresolved ethical and social issues. Phase III studies should be abandoned for most drugs, and substituted with properly powered Phase II doseranging studies plus careful post-marketing surveillance. Phase III should be a penalty for poor drug development, not a regulatory requirement. To accomplish efficient drug development, greater cooperation between pharmaceutical companies and governments in developing clinical trials is needed rather than over-regulation. These changes will synchronize the drug development and regulatory process with the current rapid drug discovery process, reduce drug development time and cost, and improve patient care. The author is Adjunct Professor of Medicine, Weill Medical College of Cornell University, New York, New York, USA.     

The immoral gene: Does it really exist?

Over the last years several European patents were opposed for protecting technology violating the morality requirement under Article 53(a) EPC. Attempts have been made by the Appeal Boards of the European Patent Office (EPO), as well as by amendments introduced into the Implementing Regulations of the European Patent Convention (EPC), to address this sensitive patentability requirement more precisely. The most recent hot topic coming up in this context is the patentability of stem cells. It is to be expected that this discussion will still go on in the field of biotechnological inventions for the next several years. An earlier version of this paper was presented at an international conference, “The Ethics of Intellectual Property Rights and Patents,” held in Warsaw, Poland on 23–24 April, 2004.     

The growing complexity of international policy in intellectual property

Intellectual property has historically been a self-contained policy at the international level. With the introduction of the TRIPs Agreement in 1994 and developments since the conclusion of the TRIPs Agreement, the relationship between intellectual property policy and other areas of public policy has become much more complex and interactive. This shift reflects the centrality of intellectual property in the knowledge economy, the rapid development of enabling technologies, notably the Internet and biotechnology, and the advent of the networked society. The consequences of this shift are manifold and herald the increased sophistication and complexity that may be expected of intellectual property regimes in the knowledge economy. An earlier version of this paper was presented at an international conference, “The Ethics of Intellectual Property Rights and Patents,” held in Warsaw, Poland on 23–24 April, 2004.     

The gap between law and ethics in human embryonic stem cell research: Overcoming the effect of U.S. Federal policy on research advances and public benefit

Key ethical issues arise in association with the conduct of stem cell research by research institutions in the United States. These ethical issues, summarized in detail, receive no adequate translation into federal laws or regulations, also described in this article. U.S. Federal policy takes a passive approach to these ethical issues, translating them simply into limitations on taxpayer funding, and foregoes scientific and ethical leadership while protecting intellectual property interests through a laissez faire approach to stem cell patents and licenses. Those patents and licenses, far from being scientifically and ethically neutral in effect, virtually prohibit commercially sponsored research that could otherwise be a realistic alternative to the federal funding gap. The lack of federal funding and related data-sharing principles, combined with the effect of U.S. patent policy, the lack of key agency guidance, and the proliferation of divergent state laws arising from the lack of Federal leadership, significantly impede ethical stem cell research in the United States, without coherently supporting any consensus ethical vision. Research institutions must themselves implement steps, described in the article, to integrate addressing ethical review with the many legal compliance issues U.S. federal and state laws create. The opinions expressed in this article are the author’s own, and are not necessarily the opinions of others, including Children’s Hospital Boston. Portions of earlier versions of this article were previously published by the American Bar Association and the New York State Bar Association.     

Introducing ethics across the curriculum at South Dakota school of mines and technology

This paper describes how the Electrical and Computer Engineering Department at South Dakota School of Mines and Technology has chosen to integrate ethics into their curriculum. All university freshmen engineering students are introduced to ethics through the presentation of ethical dilemmas. During this exercise, students are forced to argue both sides (‘for’ and ‘against’) of a hypothetical ethical engineering dilemma. It provides a setting for great discussion with the desired outcome that they learn to carefully analyze a situation before they draw conclusions. In the sophomore year, students are introduced to methods to use the fundamental principles, the fundamental canons, and the suggested guidelines for use with the fundamental canons of ethics when analyzing appropriate action to be taken when confronted with ethical dilemmas. We currently use the ‘sophomore’ method for seniors because the sequencing is just beginning. Next year the seniors will do more indepth analysis of ethical case studies. An earlier version of this paper was presented at the Fourteenth Annual Meeting, Association for Practical and Professional Ethics, February 24–27, 2005.     

Nanotechnology — A new field of ethical inquiry?

Parallel to the public discussion on the benefits and risks of nanotechnology, a debate on the ethics of nanotechnology has begun. It has been postulated that a new “nano-ethics” is necessary. In this debate, the — positive as well as negative — visionary and speculative innovations which are brought into connection with nanotechnology stand in the foreground. In this contribution, an attempt is made to discover new ethical aspects of nanotechnology in a more systematic manner than has been the case. It turns out that there are hardly any completely new ethical aspects raised by nanotechnology. It is much rather primarily a case of gradual shifts of emphasis and of relevance in questions which, in principle, are already known and which give reason for ethical discussions on nanotechnology. In a certain manner, structurally novel ethical aspects arise through the important role played by visions in the public discourse. New questions are also posed by the fact that previously separate lines of ethical reflection converge in the field of nanotechnology. The proposal of an independent “nano-ethics”, however, seems exaggerated.     

Topics and cases for online education in engineering

When considering offering online education for engineering ethics instruction, making choices necessary for the effective development and delivery of an engineering ethics curriculum is an important first step. Selecting the topics and types of cases for the most effective ethics education of engineering students is a vital step in preparing an effective program. Examples are presented for topics which are considered good candidates for online presentation, and the adaptability of these topics for web-based instruction is discussed. Types of cases which are useful in engineering ethics education are presented. Methods of teaching applied ethics, as well as ideas for web-based ethics course design are suggested. The market for web-based instruction is discussed.     

Teaching research ethics: Can web-based instruction satisfy appropriate pedagogical objectives?

Ethical tasks faced by researchers in science and engineering as they engage in research include recognition of moral problems in their practice, finding solutions to those moral problems, judging moral actions and engaging in preventive ethics. Given these issues, appropriate pedagogical objectives for research ethics education include (1) teaching researchers to recognize moral issues in their research, (2) teaching researchers to solve practical moral problems in their research from the perspective of the moral agent, (3) teaching researchers how to make moral judgments about actions, and (4) learning to engage in preventive ethics. If web-based research ethics education is intended to be adequate and sufficient for research ethics education, then it must meet those objectives. However there are reasons to be skeptical that it can.     

Educational technologies and the teaching of ethics in science and engineering

To support the teaching of ethics in science and engineering, educational technologies offer a variety of functions: communication between students and instructors, production of documents, distribution of documents, archiving of class sessions, and access to remote resources. Instructors may choose to use these functions of the technologies at different levels of intensity, to support a variety of pedagogies, consistent with accepted good practices. Good pedagogical practices are illustrated in this paper with four examples of uses of educational technologies in the teaching of ethics in science and engineering. Educational technologies impose costs for the purchase of hardware, licensing of software, hiring of support personnel, and training of instructors. Whether the benefits justify these costs is an unsettled question. While many researchers are studying the possible benefits of educational technologies, all instructors should assess the effectiveness of their practices.