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At least 145 records · Page 8Linked to original sources
PubMed1978

Is it ethical to conduct volunteer studies within the pharmaceutical industry?

There is a case for appropriately selected drug studies within the pharmaceutical industry in which employee volunteers are used. Provided the organisation and conduct of such studies are approached in an ethical manner, with attention to safe-guarding the volunteer and recognising the limitations, this work can be done expeditiously, cheaply, and safely. Some details are given of the arrangements made for volunteer studies within a company.

Adolescent↗
PubMed2004

[Influence of pharmaceutical advertising on the physician. A contribution to ethics in medicine].

Physicians who prescribe medicaments to patients are the preferred target group of sales promotion by pharmaceutical industry. As studies show, pharmaceutical advertising actually exerts some influence on a physician's knowledge and habit of prescribing medicine, to the point of even inducing him to give preference to a special drug. Information on pharmaceuticals given by advertisements may contain some potential of bias, instead of offering the physician a chance of objectives additional training. Free gifts from the pharmaceutical industry may easily plunge a physician into a conflict of interest while giving therapy with drugs. The gift relationship established between him and pharmaceutical enterprises is apt to mutate to some sort of commitment he owes to the givers. Favouring a drug which has come about through he influence of advertising, can thus violate the principles of "good prescribing". For a treatment which contains potential for bias and a conflict of interest cannot possibly match the profession's principles of responsibility, fostering informed choice (autonomy), protecting the patient from harm (nonmaleficence), acting in a patient's best interest (beneficence), and promoting equity in health care (justice). Each physician should therefore be aware of possibly belonging to a preferred target group pharmaceutical sales promotion is aiming at. He should take an independent attitude while acquiring knowledge, and critically view the adequateness of free gifts he is offered. Even students of medicine should be encouraged to critically reflect on the necessary and essential relationship to pharmaceutical industries so that it may be moulded according to the benefit of the patients.

Advertising↗
PubMed2006

Guidelines for interactions between clinical faculty and the pharmaceutical industry: one medical school's approach.

A productive and ethical relationship between the pharmaceutical industry and physicians is critical to improving drug discovery and public health. In response to concerns about inappropriate financial relationships between the pharmaceutical industry and physicians, national organizations representing physicians or industry have made recommendations designed to reduce conflicts of interest, legal exposure, and dissemination of biased information. Despite these initiatives, the prescribing practices of physicians may be unduly influenced by the marketing efforts of industry and physicians may inadvertently distribute information that is biased in favor of a commercial entity. Moreover, physicians may be vulnerable to prosecution through federal anti-kickback and false claims statutes because of potentially inappropriate financial relationships with pharmaceutical companies. Since academic medical centers have a critical role in establishing professional standards, the faculty of Yale University School of Medicine developed guidelines for the relationships of faculty with the pharmaceutical industry, which were approved in May 2005. Input from clinical faculty and from representatives of the pharmaceutical industry was utilized in formulating the guidelines. In contrast to existing recommendations, the Yale guidelines, which are presented as an Appendix here, ban faculty from receiving any form of gift, meal, or free drug sample (for personal use) from industry, and set more stringent standards for the disclosure and resolution of financial conflict of interest in Yale's educational programs. The growing opportunities for drug discovery, the need to use medications in a more evidence-based manner, and preservation of the public trust require the highest professional standards of rigor and integrity. These guidelines are offered as part of the strategy to meet this compelling challenge.

Codes of Ethics↗
PubMed2006

Pharmaceutical promotion and GP prescription behaviour.

The aim of this paper is to empirically analyse the responses by general practitioners to promotional activities for ethical drugs by pharmaceutical companies. Promotion can be beneficial as a means of providing information, but it can also be harmful in the sense that it lowers price sensitivity of doctors and it merely is a means of maintaining market share, even when cheaper, therapeutically equivalent drugs are available. A model is estimated that includes interactions of promotion expenditures and prices and that explicitly exploits the panel structure of the data, allowing for drug specific effects and dynamic adjustments, or habit persistence. The data used are aggregate monthly GP prescriptions per drug together with monthly outlays on drug promotion for the period 1994-1999 for 11 therapeutic markets, covering more than half of the total prescription drug market in the Netherlands. Identification of price effects is aided by the introduction of the Pharmaceutical Prices Act, which established that Dutch drugs prices became a weighted average of the prices in surrounding countries after June 1996. We conclude that GP drug price sensitivity is small, but adversely affected by promotion. Ltd.

Drug Costs↗
PubMedDate not supplied

External validity of randomised controlled trials: "to whom do the results of this trial apply?".

In making treatment decisions, doctors and patients must take into account relevant randomised controlled trials (RCTs) and systematic reviews. Relevance depends on external validity (or generalisability)--ie, whether the results can be reasonably applied to a definable group of patients in a particular clinical setting in routine practice. There is concern among clinicians that external validity is often poor, particularly for some pharmaceutical industry trials, a perception that has led to underuse of treatments that are effective. Yet researchers, funding agencies, ethics committees, the pharmaceutical industry, medical journals, and governmental regulators alike all neglect external validity, leaving clinicians to make judgments. However, reporting of the determinants of external validity in trial publications and systematic reviews is usually inadequate. This review discusses those determinants, presents a checklist for clinicians, and makes recommendations for greater consideration of external validity in the design and reporting of RCTs.

Data Interpretation, Statistical↗
PubMed2004

[Placebo-controlled trials in schizophrenia].

BACKGROUND: Clinical trials involving human subjects give rise to ethical and medico-legal dilemmas. Essential research of new drugs may potentially expose patients to ineffective medications or to placebo. The complexity of the problem increases when dealing with mentally ill patients, for whom, on the one hand there is no known cure for their disease, and on the other hand, it is sometimes questionable whether or not they are able to provide informed consent to participate in clinical trials. PURPOSE: The Israel Psychiatric Association decided to develop a position paper on the subject of placebo-controlled clinical trials in schizophrenia patients. METHODS: Discussion groups were established, and the available material in the professional literature was examined, with an emphasis on recent developments. The Declaration of Helsinki and its amendments were analyzed, and experts in the field were consulted. DISCUSSION: Clinical drug trials for development of new medications are essential in all fields of medicine, especially in psychiatry. The requirement for a placebo arm in pharmaceutical trials presents ethical and clinical dilemmas that are especially complicated with regard to mentally ill persons whose free choice and ability to provide informed consent may be questionable. However, we do not believe that this predicament justifies unconditional rejection of placebo use in psychiatry, when it may provide substantial benefit for some patients. Simultaneously, it is our duty to provide stringent restrictions that will enable strict supervision over the scientific, clinical and ethical aspects of the trials. CONCLUSIONS: We propose the following criteria for approval of pharmaceutical trials that include a placebo arm: scientific justification; clinical and ethical justification; provision of informed consent; recruitment of patients hospitalized voluntarily; prevention of harm; administration of additional potential therapeutic interventions; benefit to patients participating in the study; control and follow-up procedures for the study as determined by the local Helsinki Committee; and appointment of a supervisory mechanism by the administration of the medical institution where the study is being performed.

Clinical Trials as Topic↗
PubMed1989

Harvey A.K. Whitney lecture. Taking charge of the profession.

The relationship between pharmacists' attitudes toward the profession and their career opportunities is described. Pharmacists must be committed to the idea that pharmacy is an essential component of health care. Pharmacy education needs to instill an attitude of service and excellence and an expectation of success. Social, political, economic, and professional change has challenged fundamental assumptions and values that made life predictable in the past. Pharmacists have permitted others to establish the scope and limits of professional pharmacy practice; it is time for pharmacists themselves to determine the future of their profession by focusing on providing services to fulfill unmet health-care needs. The profession as a whole will suffer if pharmacists view certain practice roles or settings as inferior. When all pharmacists accept "drug-use control" as the primary ethic that drives pharmaceutical decisions, the public, the government, and other health-care providers will respect that role for pharmacists. Studying the pharmacy literature can enhance pharmacists' positive feelings about their contributions. Pharmacists alone are responsible for the status of the profession and for changing what needs to be changed. By changing their thinking about the profession, pharmacists can broaden their career opportunities.

Attitude of Health Personnel↗