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PubMed1993

Experiences with GCP in the pharmaceutical industry [corrected].

The Declaration of Helsinki and the "new" Germany Drug Law of 1976 may be regarded as the first and all important step in the evolution of Good Clinical Practices (GCP) in Germany. "Regulations on the orderly conduct of clinical studies" (published in 1987), reflecting most elements of the GCPs, caused the German industry to make provisions for more successful drug approvals in the future. Pharmaceutical companies have improved their documentation systems with regard to study protocols and reports, increased their monitoring capacity, and began setting up SOPs. In preparation for the issuing of the E.C. GCP guidelines companies established Clinical Quality Assurance (CQA) units responsible for various CQA tasks such as training of monitors and investigators, auditing of protocols, reports, systems, and data. Typical problems connected with the implementation of GCP in Germany appear to be contradictory opinions of the various ethics committees, reluctancy on the part of investigators to assume additional bureaucratic workload, difficulties on the part of the sponsor resulting from the high financial and manpower requirements, as well as the relatively unfavorable political and public opinion of clinical research. The benefits achieved by the introduction of GCP are already visible, i.e., increased quality of study protocol, conduct and report of studies, reduced number of studies, transparency at all stages of clinical research and increased ethical awareness.

Clinical Trials as Topic↗
PubMed2006

When physician-industry interactions go awry.

Financial connections between members of the profession and professional organizations and the pharmaceutical, device, and biotechnology industries are increasingly common and can lead to biased medical decision making, higher costs of care, and decline in the public's trust of the profession. To preserve its reputation and its autonomy over medical decisions, the profession must begin to police itself.

Bias↗
PubMed2004

Evaluation of the use of reporter antigens in an auricular lymph node assay to assess the immunosensitizing potential of drugs.

Immune-mediated idiosyncratic drug reactions are a major problem for susceptible patients, physicians, and the pharmaceutical industry. Validated screening tools to assess the immunosensitizing capacity of orally or intravenously administered pharmaceuticals are currently not available. To date, the popliteal lymph node assay (PLNA) seems the most promising tool for this purpose. The PLNA has recently been extended with the use of reporter antigens (RA) that are coinjected together with the drug of interest. The measurement of isotypes of RA-specific antibody-secreting cells (ASC) enables the distinction of sensitizing chemicals and (nonsensitizing) irritants without radio-isotopic end points. However, the use of footpad injections raises ethical concerns. Therefore, we examined the use of RA after intradermal injection into the ear of BALB/c mice and measured RA-specific ASC in the draining auricular lymph node (ALN). We show that RA-specific IgG isotype ASC numbers are very useful and sensitive parameters to identify drug-induced hypersensitivity in both PLN and ALN. However, the type 1-associated parameters (CD8(+) cells, macrophages, IFN-gamma, TNF-alpha, and IL-1 beta) that are induced in the PLN by streptozotocin were less pronounced in the ALN. Thus, the PLNA may provide more immunologically relevant information on the mechanisms of certain chemical-induced hypersensitivity reactions. The RA-ALN assay may provide an alternative for the RA-PLNA; both assays can be used to distinguish sensitizing compounds from nonsensitizing ones.

Animals↗
PubMed1993

Drawing a line between killing and letting die: the law, and law reform, on medically assisted dying.

While much has been written about the professional ethics of physician assisted dying, little is known about where the law draws the line, whether the law is enforced in practice, and how the law should be reformed to reflect changing public opinion and ethical thought. This article addresses these questions and the need for clearer public policy [in the United States] on physician assisted dying.

Civil Rights↗
PubMed2000

Pharmacogenomics: the genomics of drug response.

Pharmacogenomics is defined as the study of the association between genetics and drug response. This is a rapidly expanding field with the hope that, within a few years, prospective genotyping will lead to patients being prescribed drugs which are both safer and more effective ('the right drug for the right patient', or personalized medicine). There are many existing examples in the literature of strong associations between genetic variation and drug response, and some of these even form the basis of accepted clinical tests. The molecular basis for some of these associations is described, and includes examples of variation in genes responsible for absorption and metabolism of the drug, and in target and disease genes. However, there are many issues surrounding the legal, regulatory and ethical framework to these studies that remain unanswered, and a huge amount of education both for the public and healthcare professionals will be needed before the results of this new medicine can be widely accepted.

Drug Therapy↗
PubMed1981

The gastrointestinal tract as a vehicle for drug smuggling.

Four cases of attempts to smuggle narcotics (marijuana, heroin, and cocaine) by swallowing a large number of drug-filled foreign bodies (condoms and capsules) and hiding them from customs authorities in the gastrointestinal canal during transit are described. This is compared with a psychiatric patient who swallowed 48 Vicks Inhalers. Drug smuggling by swallowing condoms or capsules containing narcotics is now a worldwide ethical-legal problem. It also is of therapeutic and prognostic importance as this may lead to such emergencies as mechanical obstruction, rupture of the drug-containing foreign bodies, and life-threatening intoxication of the carrier.

Adult↗
PubMed1997

Decisions at the end of life: Catholic tradition.

Medical decisions regarding end-of-life care have undergone significant changes in recent decades, driven by changes in both medicine and society. Catholic tradition in medical ethics offers clear guidance in many issues, and a moral framework accessible to those who do not share the same faith as well as to members of its faith community. In some areas, a Catholic perspective can be seen clearly and confidently, such as in teachings on the permissibility of suicide and euthanasia. In others, such as withdrawal of nutrition and hydration, the Church does not yet speak with one voice and has not closed out the discussion. Yet, it is not in the teaching on individual issues that a Catholic moral tradition offers the most help and comfort, but in its account of what it means to lead a life in Christ, and to prepare for a Christian death. As in the problem of pain and suffering, it is the spiritual support more than the ethical guidance that helps both patients and physicians bear the unbearable and fathom the unfathomable.

Attitude to Death↗
PubMed1992

Hospital pharmacy in 1991: the year in review.

Issues and activities that dominated hospital pharmacy in 1991 are reviewed, and their relationship to political and economic trends of national and international importance is described. While rising costs, equitable reimbursement, and access to care continued to dominate the nation's health-care agenda in 1991, the growing interest in quality assurance was also noteworthy. Health-care reform will likely be a dominant issue during the current election year, and pharmacists are urged to play an active role in this restructuring process, both within their work settings and in their communities. Among the major concerns of hospital pharmacy in 1991 were the appropriate use of the new products of biotechnology, advances in computer and communications technology, and measuring and improving the quality of pharmaceutical care. Other issues highlighted in the literature included the need to articulate a mission statement concerning pharmaceutical care, the role of specialization in pharmacy practice, and the appropriate allocation of human resources. The literature of hospital pharmacy continues to provide insight into the progress of the profession and to serve as a benchmark that will gauge its future course.

Computers↗
PubMed2005

[The attitude of physicians regarding the promotion strategies of the pharmaceutical industry].

Pharmaceutical companies invest large sums of money promoting their products. They use a multifaceted approach to drug promotion, incorporating techniques such as hospital and office detailing by pharmaceutical representatives. Although these practices are commonly used, little has been published about the attitude of physicians concerning their interaction with the pharmaceutical industry. We performed a cross sectional anonymous survey to identify the extent of and attitudes towards the relationship between the physicians and the pharmaceutical industry and its representatives with its impact on the knowledge, attitude and behavior of the physicians. Internists, cardiologists and dermatologists who work in ambulatory settings from private and public hospitals in Buenos Aires city participated in this study, 44% were female, 35% residents, 65% staff physicians, averaging 41 years of age. Of these, 86% receive medical samples frecuently, 39% desk gifts, 19% invitations to congresses and 12% free lunches. Half of the doctors believe that receiving benefits from the pharmaceutical industry has an influence on medical prescription, but only 27% accept this as influential in their own prescriptions. Residents consider, more frequently than others, that these activities affect their decisions, (42% vs. 18% p = 0.007, global 30%). Most of the participants consider appropriate receiving these benefits, although 35% think that they affect the final price of medications. In conclusion, there is a high level of interaction between the pharmaceutical industry and our medical population. Although the latter recognize the influence of these interactions on prescriptions and the elevation of the cost of the final product, they find it appropriate to receive benefits.

Adult↗
PubMed2000

To treat or not to treat: a proper use of hormones and antibiotics.

Hormones and antibiotics are important remedies in animal reproduction. Compared to other areas of application, hormones are probably more used than antibiotics. The quantities of hormones applied in cattle reproduction are largely dependent on whether these drugs are extensively used for pharmaceutical control of breeding or not. Diseased animals should be treated both from an animal welfare point of view and to restore their production capacity. The treatment should be based on an accurate diagnosis. Some of the treatment methods used in animal reproduction do not seem to be well documented. When using antibiotics, it should be known that an infectious agent is present which will be susceptible to therapy. The use of hormones and antibiotics to solve or mask managerial problems should be avoided. Ideally, fertility and health traits should be included in a breeding programme. Therefore, all diagnoses and treatments performed should be recorded and these data made available for breeding purposes. Manipulation of the breeding cycle by pharmaceutical means should not disturb the natural reproductive performance of animals being progeny tested. Animal health and fertility should be improved by selection and good management rather than by extensive use of hormones and antibiotics. Cases of inappropriate use of pharmaceutical preparations have created a general scepticism among people concerning the use of hormones and antibiotics in modern farming. Evidence of increasing resistance to antibiotics in bacteria infecting humans has focused on the role that anti-microbial drug use in food-producing animals plays in the emergence of resistant bacteria. There is also a concern about possible residues in animal products. Further, the consumers have a growing interest in animal health and animal welfare issues, and they have ethical concerns regarding the use of hormones and antibiotics, in particular, as performance enhancers. In Europe, the number of farmers growing organically cultivated foodstuffs is increasing, and according to the regulations for organic farming, the use of hormones and antibiotics is limited. Even though the proper use of hormones and antibiotics does not have any known negative effect on animal welfare or public health, the consumers' concerns have to be taken into account in livestock production.

Animals↗
PubMed1997

[Plasma-derived products: therapeutic biological products].

The status of proprietary medicinal product has been conferred upon plasma derived products (PDP) by the European Community in its directive issued on the 14 of June 1989. This directive requires each Member State to comply with the current regulations applicable to medicinal products related to production, control and registration of PDP. A different evolution characterized the American regulation in which PDP have been classified as biological products, submitted to a particular regulation since 1992. These different conceptions led the authors to systematically review the specificities of PDP in comparison to classical medicinal products: plasmatic raw material, production of active ingredients and manufacturing of products in the same facility, divergent production of several products from a single starting material, infection risks and variability characterizing biological products, registration and distribution. The analysis of complementary regulation issued to adapt the pharmaceutical principles to the PDP shows that it does not provide all the expected answers to the specificities of the PDP. This shows the advantages that could be expected by giving a status of biological therapeutic product to the PDP. This could above all allow to federate qualified people and data in order to take into account more accurate and more immediate information about risks which may arise in very dispersed fields. This could also serve as a reminder of the ethical principles attached to the preparation of products coming from a human source.

Biological Products↗
PubMed2002

Conflict of interest in clinical research: direct payment to the investigators for finding human subjects and health information.

The recent death of teenager Jesse Gelsinger in a drug therapy trial has drawn attention to how financial conflicts of interest may compromise patient protection. While research institutions throughout the world have instituted a variety of conflict of interest guidelines, the potential conflicts associated with investigators receiving direct payment from private companies for both the recruitment of patients and the running of clinical trials in pharmaceutical research remains a relatively unexplored area. Clinical researchers undoubtedly deserve to be reasonably compensated for their participation. But these incentive mechanisms also have the potential to create conflicts of interest--both real and perceived.

Canada↗
PubMed2002

Oral antihypertensive trial design and analysis under the pediatric exclusivity provision.

BACKGROUND: The Best Pharmaceuticals for Children Act provides a 6-year extension to the economic incentives offered to drug manufacturers under the Pediatric Exclusivity Provision, for providing requested information on drugs used in children, which includes >50 oral antihypertensive medications. Guidelines were published outlining specific requirements for the design and analysis of trials to provide the requested information. METHODS: We review the design and analysis requirements, along with recruitment and eligibility guidelines, for dose-ranging studies of oral antihypertensives in children in light of ethical and methodologic issues unique to pediatric research. We also discuss examples of trials conducted to date and the implications and limitations of legislative efforts. RESULTS: Four possible trial types are outlined in the guidelines. Trial C, which uses a randomized withdrawal phase after treatment, has been used most often. Avoidance of a true placebo arm may enhance patient recruitment and minimize ethical concerns at the expense of a more complicated design and analysis. In addition, this trial involves little risk for manufacturers because patent extension does not depend on the outcome of the trial. CONCLUSIONS: Studies being conducted under the Pediatric Exclusivity Provision will provide valuable information concerning dosing and efficacy for several antihypertensive medications used in children. New legislation may stimulate study of drugs without remaining patent life, but data on safety, long-term outcomes, and the youngest pediatric age groups are also needed for a full understanding of all issues pertinent to pediatric use.

Administration, Oral↗
PubMedDate not supplied

States' control of prescription drug spending: a heterogeneous approach.

In an effort to balance Medicaid budgets, states use prescription drug cost containment tools in unique ways and in varying combinations. We report on the variability in state-level strategies to control the cost of prescription drugs and describe broad state-to-state differences in per beneficiary spending on drugs. This heterogeneity raises the question of appropriate state program variability. Research is needed to determine the medically, ethically, and legally most suitable means of controlling drug costs, especially as the Medicare Part D drug plan will likely recapitulate the prescription drug program variability observed among the states.

Aged↗
PubMed1986

[Peculiarities of drug therapy in childhood].

The age of the patient is one of the major determinants of drug efficacy due to certain anatomical, physiological, biochemical and behavioral characteristics of different age groups of the pediatric population. Qualitative and quantitative differences in pharmacokinetics and pharmacodynamics of drugs should be considered before dosage regimens can be established. Differences may occur in each age group, but may be even greater in newborns. Nevertheless, the maturation from the newborn towards adulthood proceeds through a continuum and thus involves also other age groups. Pediatricians are aware of this situation. But only for a small fraction of drugs used in newborns and infants clinical-pharmacological data are available, and drug instructions often contain disclaimer statements against the use in children. In pediatric intensive care units newborns and infants often receive drugs which have not been evaluated before within this age group. According to epidemiological data it has to be assumed that 30% of neonates in neonatal care units develop adverse side effects, which may originate from the drug itself or from drug interactions. Drug trials are completed or underway when new approaches to therapeutic interventions are developed for pediatric disease states. Examples for the development of new therapeutic interventions are for instance the use of theophylline for the prevention of apnoes in prematures, the use of indomethacin for the closure of a patent ductus arteriosus, or the specific advances of cancer chemotherapy in childhood. However, there is no doubt that a complete interplay between clinical, ethical and legal aspects renders the task of studying the effects of drugs in children more difficult than in the case of adults.

Apnea↗
PubMed2004

The ethical use of placebo in clinical trials involving children.

The authors reviewed various statements describing the ethical use of placebo-controls in clinical trials involving minors. Attention was focused upon the Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations, published by the American Academy of Pediatrics (AAP) (Kaufman et al. 1995). A brief review of certain key documents and a possible expansion of the guidelines are presented. Specifically, it is recommended that a review and update of guidelines for the use of placebo-controlled trials in children be undertaken by a working group comprised of stakeholders, including academic clinical and research professionals, bioethicists, consumers, members of key government agencies, and the pharmaceutical industry.

Child↗