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PubMed1996

Clinical pharmacology and clinical trials in Japan.

Clinical pharmacology is the pursuit of rational therapeutics by following the scientific principles of medicine and pharmacology. In Japan the roles for clinical pharmacology and clinical pharmacologists have been evolving since the discipline appeared in the 1950s. Clinical pharmacology and clinical trials for drug development depend on each other, and clinical pharmacologists play an important role in drug development in Japan. As the discipline becomes more important and complicated, many issues regarding drug therapeutics and clinical trials in Japan have been raised, and several points of view have been expressed. The following suggestions have been made to improve clinical pharmacology in Japan: (a) Medical education in the field of clinical pharmacology must be improved by creating or improving clinical pharmacology programs in medical schools. (b) The appropriate infrastructure for clinical trials must be established so that the physicians' workload is reduced, and patients' participation in clinical trials becomes much easier. (c) Scientific and ethical standards of the pharmaceutical industry must be improved, and the effort should be made to produce drugs with new mechanisms of action or with significant expected benefits. (d) The regulatory agency must provide stronger support, encompassing all the various points of view of academic institutes and the pharmaceutical industry. In light of the enthusiasm demonstrated by the government, physicians, and pharmaceutical industry in Japan for continued progress in clinical pharmacology, it seems likely that all its challenges will be overcome in the near future. Hence, despite the various problems discussed here the future seems promising for the continued development of clinical pharmacology.

Clinical Trials as Topic↗
PubMed1992

What do consumers want?

A consumers' advocate discusses the needs of the consumer in evaluating dental products. Although commending the roles of the FDA and ADA in evaluating products, numerous questions are raised and recommendations made concerning advertising claims.

Advertising↗
PubMed1990

Harvey A. K. Whitney lecture. Interdependence in pharmacy: risks, rewards, and responsibilities.

The importance of interdependence in the future of the pharmacy profession is discussed. In politics, economics, business, and health care, the pursuit of individual independence is giving way to the realization that interdependence is necessary for future success. Communication technology and the accelerated growth of new knowledge foster interdependence. When one sector of society creates large and interdependent structures, other sectors with which it interacts must do likewise to retain a balance of power or influence. Interdependence--sharing ideas and information--has helped institutional pharmacists to gain influence in health care; with this influence have come responsibilities and risks. Pharmacists' contribution to clinical research is increasingly respected and needed by the pharmaceutical industry. However, compromised ethical standards are at risk when drug companies reward pharmacists for research or presentations involving their products or for influencing prescribing of these products. Industry is also dependent on pharmacists making purchasing decisions. Biotechnology products in particular set the stage for potential conflict of interest. Pharmacy should formulate guidelines defining standards of conduct; ASHP is encouraged to establish a commission on ethics. Guidelines might require (1) that pharmacy and therapeutics committee members fully disclose any relationship with manufacturers of drugs considered for the formulary and (2) that pharmacists' publications in industry-sponsored literature and presentations at industry-supported educational programs be objective and scientifically sound. Successful organizational leadership will require the ability to identify opportunities for interdependence.

Biotechnology↗
PubMed1977

1976 Harvey A.K. Whitney lecture: the peril of deprofessionalization.

It is argued that American pharmacy is in great peril of being deprofessionalized, and that hospital pharmacy practice offers the best hope for restoring public confidence in the profession. Pharmacists are criticized for a failing sense of mission and a waning dependence on knowledge. It is observed that pharmacy has diminished control over practitioner education. Various threats to the professional association of hospital pharmacists, and the need for ethical codes enforced by the profession are discussed. The concept of an American School of Hospital Pharmacy is supported. Hospital pharmacists are urged to become drug experts; it is suggested that pharmacists in hospitals be required to develop expertise in specific categories of drugs. It is concluded that pharmacy must use its drug knowledge effectively to avoid the peril of deprofessionalization.

Education, Pharmacy↗
PubMedDate not supplied

[Research on antiemetics: an Italian model of success].

At the beginning of the 80's the Italian Group for Clinical Research (G.O.I.R.C.) identified chemotherapy-induced nausea and vomiting as one of the most distressing adverse events, and decided to plan and execute clinical trials on antiemetics in order to reduce this negative impact on patients. Therefore, some consecutive double-blind randomized trials were conducted on cisplatin-treated patients. The first was a dose-finding study on four different high-doses of domperidone, followed by a study comparing two different high-doses of metoclopramide, and a study comparing the addition of a corticosteroid to high-dose metoclopramide with respect to metoclopramide alone. Finally, a study demonstrating that a combination of a higher dose of metoclopramide (3 mg/kg x 2) plus dexamethasone and diphenhydramine was significantly superior with respect to a lower dose of metoclopramide (1 mg/kg x 4) combined with methylprednisolone was carried out. With the introduction of the 5-HT3 receptor antagonists the interest for antiemetic therapy increased and other Italian gynecological and medical oncology centres became involved in the antiemetic research. The Italian Group for Antiemetic Research was formed in 90's and its first study demonstrated the superiority of a combination of a 5-HT3 receptor antagonist plus dexamethasone with respect to the standard three drug combination of high doses of metoclopramide in the prevention of cisplatin-induced acute emesis. In the following years, the Group contributed to the identification of the best antiemetic prophylaxis for acute emesis induced by moderately emetogenic chemotherapy, and for delayed emesis induced by cisplatin. Also a drug utilization review on antiemetics in clinical practice has recently been carried out. Today, the interest of the Group is concentrated in studying the optimal antiemetic prophylaxis for delayed emesis induced by moderately emetogenic chemotherapy. The rules always followed by the Italian Group for Antiemetic Research are: --complete independence of judgement on the efficacy and the tolerability of antiemetic drugs from the pharmaceutical companies; --priority of ethical problems in designing clinical trials; --strict adherence to the methodological problems of antiemetic research and--complete autonomy concerning the study planned, the data computerization and the data elaboration. In the last twelve years approximately 70 Italian centres have enrolled their patients into the studies of the Italian Group for Antiemetic Research.

Antiemetics↗
PubMed2002

Tobacco harm reduction: a call to address the ethical dilemmas.

The 2001 Institute of Medicine report Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction has helped to focus attention on the scientific basis for assessing tobacco harm reduction products. As the tobacco research and policy communities tackle the challenges of evaluating harm reduction, there are ethical issues that must also be addressed. There has, however, been very little writing on the ethics of this field. In an effort to spur research into answering these ethical questions, we present two complementary approaches. First we outline three overarching topics in tobacco harm reduction that would particularly lend themselves to study: (a) Is the pursuit of tobacco harm reduction an ethical goal? (b) What are the ethical considerations of tobacco harm reduction vis-à-vis pharmaceutical companies? and (c) What are the ethical considerations for harm reduction vis-à-vis tobacco companies? We then present one possible framework for analyzing the ethical issues that accompany particular tobacco harm reduction strategies. By considering the ethical dilemmas attendant to tobacco harm reduction in a prospective and thoughtful manner, we will be better prepared to handle the challenges that face us individually as researchers and collectively as a tobacco control community.

Drug Industry↗