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PubMed1994

Drug firms pledge with WHO to combat AIDS.

In a joint statement, WHO (the World Health Organization) and IFPMA (the International Federation of Pharmaceutical Manufacturers) committed themselves to use their expertise "towards the resolution of the HIV/AIDS pandemic and to explore all possible areas for cooperation". Work towards discovering and developing new drugs and vaccines would proceed as rapidly as possible. In the statement, each institution defined its roles in the research, development and marketing and distribution of HIV/AIDS drugs and vaccines, with special attention to the respect of ethical standards in clinical trials, and to the accessibility of any drugs and vaccines which become available. One of WHO's main objectives is to promote the development of safe and effective new HIV/AIDS products which will be made available at prices that take into account the limited financial means of the public sector to purchase medical supplies for use in developing countries. By the year 2000, according to WHO projections, up to 40 million people may have been infected with HIV since the start of the pandemic. At the end of 1993 the cumulative number of infections was 15 million. Most new infections will occur, as they have in the past, in countries least able to afford adequate prevention measures or suitable treatment. The joint statement reflects the deep concern of IFPMA and WHO for the devastating impact HIV/AIDS can have in such countries--not only on the health of their populations, but also socially or economically.

Acquired Immunodeficiency Syndrome↗
PubMed2002

Interactions of staff and residents with pharmaceutical industry: a survey of psychiatric training program policies.

OBJECTIVES: In response to perceived controversies regarding interactions between physicians and the pharmaceutical industry, we undertook a study to look at the relationship between Canadian psychiatry training programs and the pharmaceutical industry. METHODS: The authors distributed a survey to the residency program directors and chief residents of the 16 psychiatry training programs in Canada. RESULTS: Of respondents, 75 per cent were either unaware of or noted an absence of policies or guidelines regarding interactions with the pharmaceutical industry in their training programs; 70 per cent viewed staff psychiatrists and residents to be at least 50 per cent familiar with the Canadian Medical Association's policy summary; and 74 per cent were unaware of any structural teaching regarding potential conflicts of interest between psychiatry and the pharmaceutical industry. A significant number of respondents perceived occasional excessive influence by the pharmaceutical industry on residents' training. CONCLUSIONS: Despite concerns about potential conflicts of interest, there are a few guidelines in most psychiatry training programs in Canada regarding the relationship between physicians and the pharmaceutical industry.

Canada↗
PubMed1994

"How much do you get paid if I volunteer?" Suggested institutional policy on reward, consent, and research.

Pharmaceutical companies often ask practicing physicians to conduct phase IV or postmarketing research on new drugs. Companies pay physicians to enroll their patients and report dosage and side-effect information. Postmarketing research embraces a multibillion dollar effort at promotion and familiarization, but subjects' informed consent to it normally does not include physician reward. Improving investigators' financial status while increasing medical risks to phase IV subjects is ethically unsound, especially if subjects are unaware of investigators' rewards. We suggest a model policy and guidelines that affirm subjects' need for informed consent, investigators' need for recognition and support, and institutions' need to protect patients from undisclosed risk and relations.

Clinical Trials, Phase IV as Topic↗
PubMed1987

[Strife between the dispensing physician and the pharmacist--a historical overview IV. 1979-1987].

In 1981 a liaison committee established between the Medical Association of South Africa (MASA) and the Pharmaceutical Society of South Africa (PSSA) to probe the dispensing-doctor issue, published a joint declaration of co-operation. After a brief truce, however, relationships deteriorated again. Pharmacists claimed that the numbers of dispensing doctors were rapidly increasing and each profession accused the other of breaking the agreement. According to the PSSA many doctors were transgressing the MASA's guidelines and the Medical Council's ethical rule 28 by trading in medicines. Subsequent legislation approved by the Council and designed to obviate this problem brought unexpected complications, and led to a joint effort by the Medical Council and the Pharmacy Council to reach an acceptable compromise. In 1984 a tentative agreement was reached but not endorsed by the full Medical Council, largely because of pending recommendations from the Competition Board which would profoundly affect dispensing by pharmacists and doctors. These recommendations were made public in November 1986, and the Government's response to them is still being awaited. The author finally summarises the status quo of the age-old feud as he perceives it.

Association↗
PubMed2002

Liability for the psychiatrist expert witness.

OBJECTIVE: An increasing number of general psychiatrists are acting as expert witnesses in the legal system. The purpose of this article is to help psychiatrists who are interested in doing forensic work by informing them of the risks entailed. METHOD: The author reviews the medical and legal literature about expert witness immunity. RESULTS: The author explains the traditional concept of expert witness immunity and shows how a variety of factors have led to the erosion of this immunity. These factors include the proliferation of experts, the inadequacy of traditional safeguards of potential prosecution for perjury and cross-examination, the growth of attorney malpractice, the lack of protection of the injured party from unscrupulous witnesses, and the ineffectiveness of Daubert v. Merrell Dow Pharmaceuticals. Examples are given of how expert witnesses are being held accountable by professional associations and state medical boards and through tort liability. CONCLUSIONS: The author provides risk-management strategies and guidelines for psychiatrists who are considering engaging in forensic work.

Ethics, Medical↗
PubMed1999

Assessment of biotechnology drugs: what are the issues?

Biotechnology is increasingly regarded as an important reservoir for the development of new and innovative, but generally expensive, pharmaceuticals. At the same time, concerns about cost containment have triggered a keen interest in evaluating and comparing the values of diverse health care interventions. In this paper we studied the process of assessment and diffusion of biotechnology drugs by studying three cases, i.e. nebacumab, colony stimulating factors and recombinant human growth hormone. These cases are evaluated in a standardised format, concerning safety, efficacy, cost-effectiveness and ethical, legal and social issues. Many factors that determine the fate of a biotechnology drug seemed to be similar to those of 'classical' drugs. The definition and measurement of clinically relevant outcomes has been identified as a key factor in the assessment process. Another important issue is the relatively small population for the primary indications of biotechnology drugs and the subsequent process of broadening of indications. Paradoxically, the current trend towards evidence-based medicine means that we will increasingly have to make decisions based on 'incomplete' knowledge'.

Antibodies, Monoclonal↗
PubMed2001

Efficacy testing of cosmetic products. A proposal to the European Community by the Danish Environmental Protection Agency, Ministry of Environment and Energy.

BACKGROUND/AIMS: Regulations for cosmetic products primarily address safety of the products that may be used by large populations of healthy consumers. Requirements for documentation of efficacy claims are only fragmentary. This synopsis aims to review and conclude a set of standards that may be acceptable to the European Community, and the cosmetic industry, as a legal standard for efficacy documentation in Europe in the future. METHODS AND RESULTS: Ethical, formal, experimental, statistical and other aspects of efficacy testing are described, including validation, quality control and assurance. The importance of user relevant clinical end points, a controlled randomized trial design and evidence-based cosmetic product documentation, validation of methods, statistical power estimation and proper data handling, reporting and archiving is emphasized. The main principles of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) good clinical practice (GCP) should be followed by the cosmetics industry in a spirit of good documentation standard and scientific soundness, but full GCP is not considered mandatory in the field of cosmetics. Documentation by validated bio-instrumental methods may be acceptable, but efficacy documentation based on information about raw materials, reference to literature and laboratory experiments are only acceptable in exceptional cases. CONCLUSIONS: Principles for efficacy substantiation of cosmetic products in Europe, as described in this synopsis, are officially proposed by the Danish Ministry of Environment and Energy to the European Community as a basis for an amendment to the Cosmetics Directive or otherwise implemented as a European Community regulation.

Clinical Trials as Topic↗
PubMed1994

Conflicts of interest: research and clinical care.

Conflicts of interest and other ethical dilemmas occur in Alzheimer disease (AD) patient care and research but often are underrecognized by physicians. One or more bioethical principles of autonomy, confidentiality, truth telling, beneficence, and justice, which apply to demented individuals as they do to other patients, may conflict in everyday clinical situations. For example, when demented patients wish to continue driving, autonomy (the patient's right to self-determination) conflicts with beneficence (the duty to promote the patient's welfare). Cognitively impaired patients depend on others for ethical decision making in the resolution of these dilemmas. It is essential that clinicians and investigators involved in the decision-making process do so without bias or conflict of interest. Full disclosure of financial interests increasingly is an accepted requirement in the conduct of biomedical research. In AD, less obvious potential conflicts of interest arise when physicians recruit their patients for antidementia drug trials sponsored by a pharmaceutical company (that provides the physician with research funding) or when investigators fail to acknowledge the patient's withdrawal of assent when attempting to complete a research protocol. The recognition of both financial and nonfinancial conflicts should lead to measures to reduce bias, which in turn will improve the integrity of research findings and promote patient welfare.

Aged↗
PubMed2006

Centralized drug review processes: are they fair?

Numerous countries have implemented centralized drug review processes to assist in making drug coverage decisions. In addition to examining the final recommendations of these bodies, it is also important to ensure fairness in decision making. Accountability for reasonableness is an ethics-based framework for examining the fairness of priority setting processes. The objective of this study was to assess the fairness of four internationally established centralized drug review processes using accountability for reasonableness. Semi-structured telephone interviews were conducted with stakeholders in Canada, New Zealand, Australia and the UK (n=16). Participants were asked to evaluate their country's centralized drug review process against the four conditions of accountability for reasonableness. Each centralized drug review process satisfied at least one of the four ethical conditions, but none satisfied all four conditions. All participants viewed transparency as critical to both the legitimacy and fairness of centralized drug review processes. Additional strides need to be made in each of the four countries under study to improve the fairness of their centralized drug review processes. Ideally, a fair priority setting process should foster constructive stakeholder engagement and enhance the legitimacy of decisions made in assessing pharmaceutical products for funding. As policy makers are under increasing scrutiny in allocating limited resources, fair process should be seen as a critical component of such activity. This study represents the first attempt to conduct an international comparison of the fairness of centralized drug review agencies in the eyes of participating stakeholders.

Australia↗
PubMed1995

[New horizons for medicine on the basis of genetic technology].

In case of a single gene defect a number of appropriate gene probes are available for prenatal diagnosis. Knowledge of the genetic disorders enables in some cases early onset of therapy or the option for abortion. However, gene technology which enables the diagnosis should not be viewed from an ethical point of view but rather the action taken when diagnostic results are available. Gene therapy for a single gene defect still is at the early stage of development. Only few patients have been treated in various indications. Difficult to be overcome are the low frequency and unspecific integration of inserted DNA into the chromosome, lack of sufficient transcription control and short half-lives of the integrated gene. From an ethical perspective gene therapy complies with the therapeutic concept of medicine. Antisense oligonucleotides are under clinical development for blockage of the synthesis of oncogenes and viral proteins. Stability of obligonucleotides as well as selectivity for specific cells will have to be overcome for broader application. Its therapeutic application is in accordance with the ethical principles of medicine. Substitution therapy with recombinant DNA derived human proteins is in therapeutic application to replace their counterparts from native source by human pharmacologically active proteins which cannot be isolated from their natural source. For recombinant DNA derived proteins where the mode of action is known short development times frames can be expected allowing an early return on investment. The expected market potential for recombinant DNA derived pharmaceuticals in 1995 will reach 4.4 billion DM.

Animals↗
PubMed1999

Telemedicine and telepharmacy: current status and future implications.

Uses of telemedicine are described and potential roles for pharmacists are discussed. Telemedicine has been defined as "the use of electronic information and communications technologies to provide and support health care when distance separates the participants." Technologies included in telemedicine are videoconferencing, telephones, computers, the Internet, fax, radio, and television. Telepharmacy has the same basic definition but refers to pharmaceutical care provision. Although the videotelemedicine market is expected to grow considerably, lack of reimbursement and high costs are continuing obstacles. Pharmacy is using video-conferencing for education, training, and management purposes. The telephone has changed from a dial-and-talk instrument to a multimedia access tool. Medical devices are being attached to telephone lines to provide remote monitoring and therapy, and call centers are providing medication counseling, prior authorization, refill authorization, and formulary compliance monitoring. Although the Internet has quickly become a star performer, utilization by health care lags behind that of other industries. The Internet-fueled empowerment of consumers and their expectations for speed, access, and convenience are creating more unmet expectations of the traditional health care system. Pharmacy has both organizational and individual practitioner Web sites, but it is online drugstores that are attracting most attention. Potential benefits of telemedicine include improved access to care, greater efficiency in diagnosis and treatment, higher productivity, and market positioning for the coming century. Telemedicine will tax the economic, regulatory, legal, ethical, and clinical care expertise of the entire health care system. Studies of the effectiveness, cost, and societal implications of telemedicine are needed, along with practice models and standards, training programs, and solutions to regulatory, licensing, and legal questions. Securing reimbursement for cognitive services remains a problem for telemedicine and telepharmacy. Telemedicine presents profound opportunities and challenges to pharmacy and other health care professions.

Accreditation↗
PubMed1999

Randomized play-the-winner clinical trials: review and recommendations.

The randomized play-the-winner rule is an adaptive randomized design, based on an urn model, that is used occasionally in clinical trials. This paper discusses practical and theoretical issues arising from its use, including stratification, delayed response, operating characteristics, selection of urn parameters, and inference. The paper also discusses recent experience with adaptive clinical trials within the pharmaceutical industry. The author concludes that the randomized play-the-winner rule is appropriate for some clinical trials, but intense and thoughtful planning must take place in the design phase. Such planning should incorporate considerations of variability, power, and appropriate techniques.

Adult↗
PubMed2003

Pain, anxiety and insomnia--a global perspective on the relief of suffering: comparative review.

BACKGROUND: The unavailability of psychotropic and analgesic drugs for medical purposes results in suffering that goes unrelieved. Their excessive availability results in overmedication and suffering of a different kind. Aims To highlight the discrepancies between the demand for and supply of controlled drugs for licit purposes by different communities, and to promote their rational utilisation. METHOD: Review of the United Nations, World Health Organization and other literature on the licit use of narcotic analgesics and psychotropic substances. RESULTS: There are large differences in the use of psychotropics and analgesics by different countries. The differences between industrialised and non-industrialised countries are particularly striking. There is evidence of unmet need in some countries and overutilisation in others. CONCLUSIONS: Governments, international organisations, health professionals and the pharmaceutical industry must work together to ensure an adequate supply of psychotropic and analgesic drugs for medical and scientific purposes, and to implement appropriate measures to minimise the development of misuse and dependence.

Analgesics↗
PubMed2003

[Historical study of clinical pharmacy education in Japan (part 2) retrospective evaluation of the roles of the one-year graduate course of clinical pharmacy practice (Yakugaku Senkouka) at Meijo University].

Clinical pharmacy practice education started 30 years ago in Japan. Since 1975, a one-year graduate course, clinical pharmacy practice (Yakugaku Senkouka), has been offered at Meijo University, making it a leading school to raise pharmacists with sufficient experience in hospital settings. This article describes the scope of the course, the development of educational systems to meet public demand for new pharmaceutical skills, and the influences on reforming the Japanese health-care system. The content consists of the following: (1) The process of building up the first curricula of clerkship, (2) requirements for admission, namely including an essay, an interview, school records and an aptitude test, (3) establishing the teaching discipline, (4) achievement goals, (5) learning process modeled on methods used in the United States, (6) establishing the concept of medical ethics, (7) professional status of course graduates, and (8) nationwide influence on the social health-care of the country. The one-year graduate course of clinical pharmacy practice was terminated in 2002 and is to be reintroduced as a two-year graduate school course to cope with the present and future trends in health-care systems.

Education, Pharmacy, Graduate↗