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PubMed2006

Ethical issues in psychopharmacology.

The marketing of selective serotonin reuptake inhibitors in the psychopharmacological industry presents a serious moral problem for the corporate model of medicine. In this paper I examine ethical issues relating to the efficacy and safety of these drugs. Pharmaceutical companies have a moral obligation to disclose all information in their possession bearing on the true risks and benefits of their drugs. Only then can patients make fully informed decisions about their treatment.

Antidepressive Agents, Second-Generation↗
PubMed2002

Ethical, legal and economic issues raised by the use of human tissue in postgenomic research.

Ethical, legal and economic framework issues concerning human samples, genetic data and bioresources are rapidly evolving. In most cases, international standards have not been defined. National legislations on the use and exploitation of human sample collections differ widely. Legislations relating to intellectual property rights, access to database information for public or private bodies, of national or foreign origin, are similarly diverse. Importation and exportation rules, concerning in particular data protection, biosafety and protection of individual rights, have not always been defined. This article makes a short assessment of the legal, ethical and economic framework in selected EC countries (Germany, France and UK), and compares them with the conditions in the USA. On the basis of the information collected, it is obvious that the use of human cells, tissues and organs in medical research has to be considered as a global, worldwide question. Such use has profound ethical, cultural and economic consequences not only in the country of origin, but also globally. Biotechnology and pharmaceutical companies conducting research with human samples are facing different framework conditions in the area of data protection, policy measures, economic support, exportation, etc., that already influence trade activities and investments of such firms at the international level. Over the 3 last years, a trend towards harmonization can be recognized: the World Health Organization has recognized the problems of postgenomic medical research as a priority. The OECD has created a taskforce on centers for biological resources. Biobanks are a common theme of the French and the German National Ethic Councils. A lack of international harmonization and consistency might not only present a challenge to biotechnology and pharmaceutical companies, but can also endanger the goals the laws and regulations seek to achieve.

Culture Techniques↗
PubMed2005

The corporate social responsibility of the pharmaceutical industry: idealism without illusion and realism without resignation.

In recent years society has come to expect more from the "socially-responsible" company and the global HIV/AIDS pandemic in particular has resulted in some critics saying that the "Big Pharma" companies have not been living up to their social responsibilities. Corporate social responsibility can be understood as the socio-economic product of the organizational division of labor in complex modern society. Global poverty and poor health conditions are in the main the responsibilities of the world's national governments and international governmental organizations, which possess society's mandate and appropriate organizational capabilities. Private enterprises have neither the societal mandate nor the organizational capabilities to feed the poor or provide health care to the sick in their home countries or in the developing world. Nevertheless, private enterprises do have responsibilities to society that can be categorized as what they must do, what they ought do, and what they can do.

Developing Countries↗
PubMed2005

The nurse as principal investigator in a pharmaceutically sponsored drug trial: considerations and challenges.

PURPOSE/OBJECTIVES: To discuss the process, considerations, benefits, and challenges of the nurse as principal investigator in a cancer care drug trial. DATA SOURCES: Published articles, anecdotal experience, and completed research studies. DATA SYNTHESIS: The specific processes that must be considered are funding sources, protocol development, trial implementation, dissemination of results, and ethical implications involved in industry sponsorship. Specific protocols are designed for evaluating adverse events. Working with pharmaceutical companies to receive financial support offers advantages but poses additional issues for consideration. CONCLUSIONS: Nurses can serve successfully as principal investigators in medication trials for cancer care. Regulatory bodies and specific procedures, as well as general considerations, mandate and guide investigator conduct when embarking on a pharmaceutical trial. IMPLICATIONS FOR NURSING: Oncology nurse researchers can look to pharmaceutical companies for potential funding in the evaluation of medications used in cancer care.

Clinical Trials as Topic↗
PubMed1996

[The rights of clinical research, especially in the area of psychiatry].

The freedom of research is guaranteed in Art. 5 sub. 3 of the German Basic Law (GG) as against intrusion by the state. Sec.s 40 AMG contain requirements for the clinical trials for pharmaceutical products which range from medical admissibility to informed consent all the way to a positive evaluation by an ethics committee. From there a route to analogy for other medical research is called for, because health and well-being of a person should be promoted even outside the area of pharmaceutical products. The international instrument of the Revised Declaration of Helsinki by the World Medical Association also requires an adequate risk and the information of the patient. Even medical research concerning the mentally ill is admissible when it is directed at the illness itself. In this case the informed consent of the guardian is normally sufficient.

Clinical Trials as Topic↗
PubMed2005

[Are children getting the right drugs?].

In recent years there has been increased attention to the fact that pharmacotherapy in children does not have the same evidence based platform as in adults. This is mainly due to the fact that most drugs being developed are only studied in adults before they are approved, both because of practical and technical difficulties in doing research on (small) children as well as ethical considerations on the inclusion of children in the testing of a new drug. Furthermore, the pharmaceutical industry has also not been very interested in developing drugs specifically for children. In 1998 the American Food and Drug Administration (FDA) established that studies in children should also be included in the development of new drugs. This was legally formalised by Congress in the Best Pharmaceuticals for Children Act (BPCA) in 2002. This has resulted in a re-evaluation of several drugs primarily developed for adults but frequently used in children. So far the FDA has changed the product information for 87 drugs, 17 drugs have been given new dosage recommendations for children, for 21 drugs the description of side effects have been changed, and 11 drugs are no longer recommended for use in children because of lack of any demonstrable effect. There has also been increased focus on better drug formulations for children. Also in Europe the need for better and safer drugs for children is given attention. The European Commission has submitted a proposal for a legal approach to the problem similar to the BPCA legislation in USA, which will probably be approved by the EU parliament and take effect in 2006. Furthermore, there is a strong commitment to establish co-operation between the pharmaceutical industry and paediatric and pharmacological networks in order to increase and facilitate drug studies in children. The European Medicines Agency will have a central role in this work by developing lists of drugs for which paediatric studies are needed and prevent unnecessary competition and duplication of studies.

Adult↗
PubMed2002

Pharmaceutical research involving the homeless.

Discussions of research involving vulnerable populations have left the homeless comparatively ignored. Participation by these subjects in drug studies has the potential to be upsetting, inconvenient, or unpleasant. Participation occasionally produces injury, health emergencies, and chronic health problems. Nonetheless, no ethical justification exists for the categorical exclusion of homeless persons from research. The appropriate framework for informed consent for these subjects of pharmaceutical research is not a single event of oral or written consent, but a multi-staged arrangement of disclosure, dialogue, and permission-giving. Payments and other rewards in biomedical research raise issues of whether it is ethical to offer inducements to the homeless in exchange for participation in drug studies. Such inducements can influence desperate persons who are seriously lacking in resources. The key is to strike a balance between a rate of payment high enough that it does not exploit subjects by underpayment and low enough that it does not create an irresistible inducement. This proposal does not underestimate the risks of research, which are often overestimated and need to be appraised in light of the relevant empirical literature.

Biomedical Research↗
PubMed1986

Controversy I: Patients or healthy volunteers for pharmacokinetic studies?

Many factors should be considered when choosing an appropriate population for a pharmacokinetic trial. Although there are some generalities that apply to most studies, each investigation must be judged separately, since the relevant considerations will vary depending on the particular study, the nature of the drug, and the population that will receive it for therapeutic benefit. Some of the most important information that is generated from pharmacokinetic studies concerns the pharmacokinetic variability among patients and the factors that can influence this variability under the conditions that the drug will be used. This information can best be obtained from a combination of baseline studies to define the variability within the patient population(s) and comparative studies to determine the impact of specific variables on the disposition of the drug and its pharmacokinetic variability. These data can provide valuable information to the clinician that can be used to individualize drug dosage and optimize therapy as well as to identify populations who may be at high risk of therapeutic failure or drug toxicity. It is our feeling that baseline studies in patients are necessary for understanding the pharmacokinetics of a drug, whereas the objectives of most comparative studies can be achieved using healthy volunteers. For most comparative studies, the data obtained from healthy volunteers will reflect what will occur in patients, especially if the variable of interest is drug absorption. This is particularly important when practical and ethical considerations preclude the use of patients. When considering studies in the elderly, one must decide whether the variable of interest may be influenced by age.(ABSTRACT TRUNCATED AT 250 WORDS)

Biological Availability↗
PubMed2001

The treatment of West syndrome: a Cochrane review of the literature to December 2000.

BACKGROUND: West syndrome is an age dependent syndrome, which includes a peculiar type of epileptic seizure (infantile spasms), usually hypsarrhythmia and in the majority psychomotor retardation. Despite huge advances in medicine it still remains a poorly understood entity and although with newer imaging techniques we are more often able to elicit the underlying 'causes' of these spasms, still little is known about their pathophysiological basis and treatment remains problematic. OBJECTIVES: To compare the effects of single pharmaceutical therapies used to treat infantile spasms in terms of long-term psychomotor development, subsequent epilepsy, control of the spasms and side effects. METHODS: A search of the central trials register of the Cochrane Epilepsy Group, medline database, embase database and the reference lists of all retrieved articles was undertaken. Correspondence with colleagues and drug companies and appeals at international conferences were also undertaken to try and discover unpublished data. All randomised controlled trials (RCTs) on the medical treatment of infantile spasms were included. Data was then extracted independently by the three reviewers and analysed using the RevMan software package. MAIN RESULTS: We found ten small RCTs on the pharmacological treatment of infantile spasms. No unpublished trials were discovered. These ten studies looked at just 335 patients treated with a total of eight different pharmaceutical agents. Overall methodology of the studies was poor, partly because of ethical dilemmas such as giving placebo injections to children. No study considered the effects of treatment on long-term psychomotor development or onset of other seizure types. One small study found vigabatrin to be more efficacious in stopping infantile spasms in a group of patients with tuberous sclerosis than hydrocortisone. One underpowered study showed a trend for vigabatrin to be more efficacious than placebo in stopping infantile spasms, another two equally underpowered studies suggested adrenocorticotrophic hormone (ACTH) to be more efficacious than low-dose prednisone. It was not possible to compare reduction in the number of spasms between the different treatments because of differences in methods of analysis. Overall, only nine patients were reported to have been withdrawn from the trial treatments due to side effects and two deaths were reported. CONCLUSIONS: There is still little evidence available on the optimum treatment for infantile spasms. Further trials with larger number of patients, and longer follow-up are required.

Adrenocorticotropic Hormone↗
PubMed2003

Healthy children as subjects in pharmaceutical research.

Recruitment of healthy children for drug research has emerged due in part to several new American laws and policies that have led to a surge in pharmaceutical research involving children-subjects. In this paper, I review the ethical and scientific issues and the arguments in favor and against this new practice.

Child↗