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PubMed1983

Legal aspects of clinical trials in Israel.

Clinical trials were mainly the concern of medical ethics until the first code on this subject was laid down in a judgment given by a military tribunal in Nuremberg in 1947. In 1964 the World Medical Association adopted the Declaration of Helsinki, which was revised in 1975, regarding clinical trials and research. The Declaration of Helsinki and the developments in the pharmacological and pharmaceutical sciences led to legislation regarding clinical trials and human experimentation. In Israel it is forbidden to use any drug that is not registered. In order to register a drug, evidence of quality, safety and efficacy is necessary, and the means by which these factors are proved is the clinical trial, which demands appropriate legislation. Developments in various medical fields, as well as new treatment techniques, brought about the need for more comprehensive legislation on experimentation on human beings and embryos. In Israel, this field is covered by two enactments, the first on drugs and the second on any other experimentation on human beings. However, these enactments are frame laws, which lay down the rule that no clinical trial may be carried out without the prior approval of the Ministry of Health. They also state the minimum conditions to be met, and provide the Ministry with the authority to add any conditions at any time, as well as the right to stop the trial. The Declaration of Helsinki serves as the minimal legal basis for clinical trials. Some legal problems relating to the clinical trial remain unsolved and are left to the discretion of the Ministry of Health. The author makes some observations and suggestions with regard to matters of consent, incompetents as subjects, the right of withdrawal, and the power of the Ministry.

Clinical Trials as Topic↗
PubMed1987

Surgery to quieten the yelling of a demented old man.

The 84-year-old man's incessant yelling caused him to be unmanageable in all settings--at home with his aged wife, in nursing homes, and on the medical and psychiatric floors of a Veterans Administration Medical Center. A host of behavioural and pharmaceutical interventions were attempted unsuccessfully. Finally, it was proposed that a single, recurrent laryngeal nerve be crushed in order to 'render his voice to be a very acceptable soft tone'.

Aged↗
PubMed1998

Self-regulatory codes of conduct: are they effective in controlling pharmaceutical representatives' presentations to general medical practitioners?

Self-regulatory codes of conduct are used to control the promotional practices of the pharmaceutical industry, but the effectiveness of these codes in controlling pharmaceutical representatives' presentations has not been examined. This is a matter of concern because pharmaceutical representatives have more influence than any other promotional media on prescribing practices. The authors developed a method for monitoring the oral presentations of pharmaceutical representatives when promoting products to medical practitioners. Sixteen audio-recordings, detailing 64 medicines, were obtained; 38 of the 64 products were prescription-only medicines. Information on indications and on dosage and administration was commonly provided, but information on other areas of drug knowledge, particularly product risk, was minimal. Thirteen presentations contained at least one inaccuracy when compared with Australian Approved Product Information. Presentations did not always comply with current guidelines in the Code of Conduct. The Code provides only limited standards for pharmaceutical representatives' presentations, and no active monitoring system is in place to ensure adherence to the code. There is an urgent need for policy development on the role of pharmaceutical representatives, their standards of practice, and regulation of their activities to ensure they contribute to the appropriate use of medicines.

Australia↗
PubMed1992

Compensation for harm: the implications for medical research.

The rising incidence of medical litigation in the 1980's led to a relatively minor modification in January 1990 of the United Kingdom's negligence-based system of medical compensation, as a result of which employing Health Authorities now accept full vicarious liability for the negligent (but not other) actions of employed clinicians (Crown indemnity). During the same period, by contrast, bodies such as the Royal College of Physicians have strongly influenced locally established Research Ethics Committees towards favouring no-fault compensation for harm resulting from medical research. The discordance between these two approaches to compensation has caused anxiety during the last year. There has been particular concern about the possible discouragement of non-commercially sponsored research. Hitherto however, no data has been available to inform this discussion. This paper reports the findings of a questionnaire survey of all research ethics committees in the United Kingdom (64% response rate), which indicates that 61% of committees require no-fault compensation for at least some projects and that 33% of these committees have rejected projects solely or mainly due to the lack of such provision. Rejection is significantly more common in Health Districts which contain teaching hospitals. Our critical analysis of the arguments advanced in favour of no-fault provision for research subjects suggests that they do not place adequate emphasis upon respect for the autonomy of individuals. We consider that it is in general more consistent with such respect fully to inform research subjects of the available compensation arrangements, rather than for ethics committees to make no-fault compensation a general requirement before ethical approval is given.

Compensation and Redress↗
PubMed2001

Industry-sponsored research in minimally invasive surgery.

In many disciplines, including minimally invasive surgery, pharmaceutical and instrument companies are major sources of industry-sponsored research. There are two types of such research, industry-initiated and investigator-initiated. Distinction between them is sometimes blurred. In industry-sponsored research a conflict may occur between clinicians and sponsor. In all cases, a clinical trial should be done properly and ethically, and results, whether negative or positive, should be published. Disposition of intellectual property and authorship should be established before starting the trial.

Humans↗
PubMedDate not supplied

Active involvement of patients in drug research, evaluation, and commercialization: European perspective.

Patients' organizations intervene more and more often in clinical research and the evaluation of medicinal products. Examples of patients' involvement in the initiation, design, recruitment, conduct, and information of clinical trials were only anecdotal until the late 80s. Prior to this date, some rare experiences were reported. At the beginning of the 80s, the AIDS epidemic certainly changed the relation between clinical research and patients, and mechanisms that drove these changes are explained. AIDS activism focused its medical activities to the following domains: (1) to accelerate access to promising new drugs and (2) to contribute to ethical clinical research. The European Medicinal Evaluation Agency (EMEA) created in 1995 offered the opportunity to simplify discussions between European Union regulatory authorities and patients' representatives: a single interlocutor now exists. Interactions between EMEA and patients' representatives vary: they can be more or less structured. Whether intrusion of patients and their representatives in clinical research and pharmaceutical product development had an impact was explored by social sciences researchers. Conclusions are mitigated.

Biomedical Research↗
PubMed1997

The gift relationship between pharmaceutical companies and physicians: an exploratory survey of physicians.

The purpose of this exploratory study was to survey physicians' attitudes surrounding the 'gift relationship' between pharmaceutical companies and physicians. A survey was mailed to 1000 randomly selected West Virginia physicians, of which 283 (28.3%) responses were received. The most commonly received gifts reported by the study physicians were trinkets (77.4%), followed by books (41.7%) and meals (41%). Principal component analysis and varimax rotation identified seven physician belief constructs. The mean ratings of the constructs indicated that the physicians slightly agreed that pharmaceutical companies give gifts to physicians to influence their prescribing, moderately disagreed that they do so as a form of professional recognition of physicians, and strongly disagreed that their prescribing behaviour could be influenced by the gifts they receive. Physicians slightly disagreed that pharmaceutical companies' sponsoring of CME programmes are only promotional gimmicks. Although the study physicians slightly disagreed that it may be inappropriate for them to accept gifts from pharmaceutical companies, they seemed slightly averse to having 'gift relationships' between pharmaceutical companies and physicians made public. Correlation analysis suggested that physicians who have a large number of patients in their practice, see a larger number of patients per day, or write a large number of prescriptions per day are more likely to be offered gifts by pharmaceutical companies, and they are also more likely to condone the practice of gift giving and receiving.

Attitude of Health Personnel↗
PubMed2005

Pharmaceutical advertisements in prescribing software: an analysis.

OBJECTIVE: To assess pharmaceutical advertisements in prescribing software, their adherence to code standards, and the opinions of general practitioners regarding the advertisements. DESIGN, SETTING AND PARTICIPANTS: Content analysis of advertisements displayed by Medical Director version 2.81 (Health Communication Network, Sydney, NSW) in early 2005; thematic analysis of a debate on this topic held on the General Practice Computer Group email forum (GPCG_talk) during December 2004. OUTCOME MEASURES: Placement, frequency and type of advertisements; their compliance with the Medicines Australia Code of Conduct, and the views of GPs. RESULTS: 24 clinical functions in Medical Director contained advertisements. These included 79 different advertisements for 41 prescription products marketed by 17 companies, including one generic manufacturer. 57 of 60 (95%) advertisements making a promotional claim appeared noncompliant with one or more requirements of the Code. 29 contributors, primarily GPs, posted 174 emails to GPCG_talk; there was little support for these advertisements, but some concern that the price of software would increase if they were removed. CONCLUSIONS: We suggest that pharmaceutical promotion in prescribing software should be banned, and inclusion of independent therapeutic information be mandated.

Advertising↗
PubMed2002

Ethical behaviour of authors in biomedical journalism.

BACKGROUND: Biomedical journals communicate new information that changes health-care decisions. If authors ignore the fundamental values of honesty and trust, that information becomes flawed, and society or patients may be harmed. OBJECTIVE: By describing two cases of unethical behaviour by authors, and using them as a focus to review acceptable ethics in publication, this article aims to educate readers who have not considered the ethical implications in writing manuscripts for biomedical journals. METHODS: Two cases of unethical behaviour by authors occurred when the results of new drug trials were reported. They were discovered after publication in a biomedical journal, and in the review process after the submission of a manuscript for publication respectively. In the first case, duplicate publication was identified because the same control data were used, but not acknowledged, in three publications by the same investigators. In the second, ghost writing by a pharmaceutical company writer was suspected because of the atypical presentation of a senior author's work. RESULTS: The editor consulted with the authors of both reports. In the first case, the authors concurred about the duplication, and the editors of the three journals wrote editorials to record the duplicate publications. The second case of ghost writing was unconfirmed by the authors, but the submission was withdrawn, and the article was later published in another journal. CONCLUSION: These cases draw attention to recently recognized types of scientific misconduct that influence the perception of scientific work. Duplicate publication and ghost writing not only deceive the reader, but may also conceal flawed study design and conflict of interest.

Animals↗