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PubMed1998

Forum on the future of academic medicine: session V--implications of basic and applied research for AMCs.

The latest meeting of the AAMC's Forum on the Future of Academic Medicine, on April 29, 1998, opened with a talk by Francis S. Collins, MD, PhD, director of the National Human Genome Research Institute, who reviewed the significant progress that the Human Genome Project (HGP) has made and speculated on how genetic discoveries and technologies would transform health-related research and ultimately the practice of medicine. The HGP's findings will offer clear improvements in diagnosis and prevention, and eventually in treatments, and the relationship between the academic medical center and the pharmaceutical industry will change--but remain good--as that industry applies the findings of the HGP. He stressed the need for the public and health care providers to develop a greater understanding of genetic issues, and urged changes in medical education to accomplish this. Forum members and Dr. Collins discussed the ethics and economics in patient care resulting from genetic research; forum members also asked whether academic medical centers could profit from genetic research findings. The second speaker was John Eisenberg, MD, administrator of the Agency for Health Care Policy and Research, which fosters health care research and disseminates to clinicians and others the findings of such research. Among other topics, Dr. Eisenberg described the new emphasis on health care outcomes and quality and described how his agency promotes research in these areas. Forum members asked who would pay for the information systems needed to communicate the findings of health services research and also noted that there is an expanding definition of health that places new pressures on already stressed academic medical centers, their missions, and their curricula, which must change. Michael Whitcomb, MD, of the AAMC, noted that the view that medical schools can't change their curricula has been proved wrong, and that 24 medical schools are working with the AAMC's Medical Schools Objectives Project on curricular reform. The forum closed with discussion of a few broader issues affecting academic medical centers.

Academic Medical Centers↗
PubMed2005

The drug industry and clinical research in interwar America: three types of physician collaborator.

This essay describes collaborations between American pharmaceutical companies and clinical investigators, mainly in academic medical centers and other research institutions, during the interwar period. I argue that efforts on the part of early twentieth-century "scientific medicine" reformers to impose higher standards on the testing and promotion of pharmaceuticals led both to the intended disciplining of the drug industry and also, as a reciprocal but unintended consequence, to a deep involvement with industry among medical scientists. Three basic patterns of collaboration between clinical trialists and sponsoring drugs firms are described. These patterns may help illuminate the mutual accommodation between ethical drug firms and academic clinical researchers (and institutions) that still prevails today.

Biomedical Research↗
PubMed2002

Conflicts of interest in drug development: the practices of Merck & Co., Inc.

Conflicts of interest are common and exist in academia, government, and many industries, including pharmaceutical development. Medical journal editors and others have recently criticized "the pharmaceutical industry," citing concerns over investigator access to data, approaches to analysis of clinical trial data, and publication practices. Merck & Co., Inc. is a global, research-driven pharmaceutical company that discovers, develops, manufactures, and markets a broad range of human and animal health products, directly and through its joint ventures. Although part of its mission is to provide a superior rate of return to its investors, Merck does not believe this creates an irreconcilable conflict of interest, particularly in activities concerning clinical drug development. We employ rigorous scientific methods to design, conduct, analyze, and report results of clinical trials in the development of innovative drugs and vaccines, with a focus on meeting unmet medical needs and with an ethic that puts the interests of the patient first. This article describes Merck's approaches to potential conflicts of interest in drug development, particularly with regard to clinical trials. We believe that proprietary interests of the Company can be respected while observing objectivity and transparency in communicating clinical research results. The standards for the review of manuscripts reporting such trials for peer-reviewed publication should be the same, whether they are from Merck or elsewhere.

Chemistry, Pharmaceutical↗
PubMed2005

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 dose-ranging 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.

Animals↗
PubMed1999

Biotechnology products and European consumers.

More than 100 interviews conducted during 1997 with European food manufacturers and retailers, trade associations, government departments, consumer groups, environmental organizations and some individual academic scientists revealed how differences in the perceived attitudes of consumers gave rise to varying approaches by suppliers to the possible introduction of transgenic foods. European consumers generally are not against the pharmaceutical products of biotechnology but are much less willing to accept food and food ingredients, especially when derived from genetically modified plants. Objections are mainly based on fears for the health and safety of the consumer, worries about the possibility of deleterious effects on the environment, and a range of moral and ethical concerns often deriving from a distaste, however expressed, at the concept of interfering with nature. Consumer understanding of the science underlying biotechnology is patchy; in no country does more than a small proportion of the population claim a good grasp. Partly no doubt as a consequence of these attitudes, the introduction of genetically modified foods into Europe has occurred slowly and, during the period of this study, perhaps only in the Netherlands and the UK.

Journal Article↗
PubMed2001

Poverty and health ethics in developing countries.

Developing countries face difficulties of exploitation, dehumanisation and lack of ethical professionalism, to an extent that developed countries do not encounter. Poverty-related difficulties include lack of infrastructure, unreasonable dominance of defence-related expenses in the budget, lack of a sufficient number of health care providers, absence of accountability for serious medical malpractice, as well as exploitation of patients in pharmaceutical trials. This country report presents the case of Bangladesh, one of the poorest countries in the world and therefore a good example for the deplorable condition of the health sector in developing countries.

Attitude to Health↗
PubMed2006

Ethical principles for psychiatric administrators: the challenge of formularies.

Rising costs continue to plague healthcare and mental healthcare. The latest variation of managed care techniques has been to try to reduce medication costs by instituting formulary restrictions. To date, the results have been spotty at best, with a suggestion of a ballooning of more general mental healthcare costs, as well as possibly worsening of quality of care. New challenges are looming in terms of the results of the CATIE study comparing typical and atypical antipsychotic medication, as well as the beginning of Medicare D medication coverage. In the midst of the uncertainty and complexity, the psychiatrist administrator has the ethical challenge and chance to make a major difference. By keeping the well-being of patients first, but also addressing the needs of the institution, payor, and other stakeholders, the psychiatrist administrator can ethically find ways to reduce costs and increase quality. One such product could be medication algorithms that also incorporate costs, side effects, and general healthcare.

Antipsychotic Agents↗
PubMed2003

Ethical issues in palliative care: considerations.

Discussions on ethics in palliative care often concentrate on issues like patient autonomy or euthanasia. However, the reality in the developing world begs discussion on an entirely different set of problems altogether. One should have a good death, no doubt, but one should also have an opportunity for a good life. Globalization unfortunately seems to worsen many of the burdens of the developing world, like the negative influence of the mighty pharmaceutical industry. Continuing medical education offered only by the pharmaceutical industry instills bias into the minds of most medical professionals. Prescription practices by many professionals are influenced by the industry; so much so, inexpensive drugs or formulations are abandoned in favor of expensive ones, adding to the burden of a much-suffering individual. Palliative care should have been a major force against such evils, but it seems to get more clinical and institutionalized with time, with the social issues taking a back seat. Unethical research practices and preferential treatment in drug availability are practices that continue to marginalize the less privileged. Adoption of the dominant ideology from the West in the developing world also raises problems like cultural unsuitability. Considering that the bulk of the suffering in the world is in poorer countries, these issues need to be addressed.

Analgesics, Opioid↗
PubMed2000

Phase I clinical trial design in cancer drug development.

The past decade has seen the publication of a number of new proposals for the design of phase I trials of anticancer agents. The purpose of these proposals has been to address ethical concerns about treating excessive numbers of patients at subtherapeutic doses of a new agent and to increase the overall efficiency of the process while enhancing the precision of the recommended phase II dose. In early 1998, a workshop of phase I investigators was held under the sponsorship of Bristol-Myers Squibb Pharmaceutical Research Institute (Wallingford, CT) to review the experience to date with novel phase I methodologies, with a particular focus on their efficiency and safety. This report summarizes the material presented. It was concluded that for phase I trials of antineoplastics (cytotoxics), which begin at 0.1 mouse-equivalent LD10 doses, evidence to date suggests that the historic approach of using a modified Fibonacci escalation and three patients per dose level is not necessary and is seldom used. One patient per dose level and more rapid escalation schemes, both empirically based and statistically based, are commonly used with apparent safety. There remain questions, however: Which of the dose escalation schemes is optimal? Are there alternatives to toxicity as a phase I end point, and will these end points be reliable in defining active doses? Answering these questions in a reasonable time frame will be important if new anticancer agents are not to suffer undue delays in phase I evaluation.

Animals↗
PubMed2001

Valuing charity.

Arrow asserted that a variety of institutional arrangements and observable mores of the medical profession were functional responses to the failure of the market to insure against uncertainties. But one of these norms--the ethic to provide treatment without regard to ability to pay--was also a response to the failure of the political system to assure the elderly and poor would not suffer more than others when they got sick. This ethic is strikingly different from the norm in most other areas of the economy. Automobile dealers and department stores are not expected to give away their products to the poor; neither are grocery stores or farmers. Public education is a closer analogy, reflecting the norm that all children deserve a good education. In education, however, unlike in medicine, we collectively support this norm by providing public funds to accomplish this goal rather than by relying on the private market. In 1963, physicians argued that a combination of the market and private philanthropy (including the obligations of physicians) would be sufficient to guarantee high-quality care for the elderly and the poor. Government financing, they argued, would lead to socialized medicine, impairing relationships between physicians and patients and between physicians and society. Based on his article, Arrow would not have agreed. Neither, apparently, did the public. The enactment of Medicare indicated, in part, that many people understood, even in 1965, the extent to which treatment choices and outcomes were affected by ability to pay. Events since 1965 suggest that there is some tension between insurance and ethical responses to uncertainty despite Arrow's endorsement of both. I have argued here that Medicare and Medicaid further eroded the ethic that treatment should be available without regard to ability to pay by reducing physician willingness to provide charity care and by reducing the resources available to public hospitals and the interest of private teaching hospitals in providing care to the uninsured poor. Largely independent of Medicare and Medicaid, the increasing importance of pharmaceuticals and other services delivered outside of the hospital further strengthened the connection between treatment choices and ability to pay, and the growth of capitated payment systems made this connection salient to many insured patients and their physicians. In part, then, the AMA was correct: Medicare and Medicaid have contributed to the erosion of trust in physicians as incorruptible agents for patients. Some of this trust undoubtedly was misplaced, even in 1965, and trust alone was not sufficient to guarantee widespread access to medical care or to assure that treatment provided would take true social benefits and costs into account. Medicare and Medicaid, as well as the growth of prepayment insurance plans, represent institutional responses to the failure of the 1963 norms to accomplish societal goals. Still, as we have seen, these responses create their own challenges, and we continue to search for institutions that will allow widespread insurance to coexist with the physician-patient trust that Arrow correctly identified as an important response to uncertainties and information asymmetries in the medical care market.

Charities↗