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PubMed2002

Review article: gastroenterology and the pharmaceutical industry.

Physicians' relationships with industry derive from the moral imperative to advocate and work for the best interests of patients. Private industry generally operates to satisfy the best interests of the stockholders or owners. Conflicts arise between these interests and are magnified by the inequality of the financial positions of physicians and industry. Because the ultimate consumer of the products (drugs, medical devices, etc.) of the biomedical industry must enlist a physician as an intermediary, the physician has become the target of industry in a sophisticated marketing effort that includes the offering of financial and other incentives. These conflicts and incentives are pervasive throughout clinical and research endeavors. Standards for resolution, if not elimination, of these conflicts have been proposed by various respected organizations. Individual physicians and medical organizations should evaluate these standards and, if pertinent and appropriate, endorse and follow them.

Conflict of Interest↗
PubMed1992

Quality of life and the death of "Baby M": a report from Australia.

... While it is no secret that Victorian doctors, like their American counterparts, are frequently making decisions that result in a severely disabled infant's death, they are making these decisions without public guidance, against the backdrop of laws and traditional ethical precepts which uphold in spirit (although, as we shall see, not always in practice) the traditional "sanctity of life" view. It will come as no surprise, therefore, that doctors and parents will occasionally find themselves in a situation where zealous defenders of an infant's "right to life" will turn to the law in an attempt to prevent what they see as immoral and unlawful decisions. This was the case recently in Melbourne, where a severely disabled infant was born on July 14, 1989 and died twelve days later, on July 26.

Australia↗
PubMed1997

Dental caries and sugar-containing liquid medicines for children in New Zealand.

Children who are taking long-term sugar-containing liquid medicines have an increased risk of developing dental caries. A recent survey of paediatric liquid medicines in New Zealand revealed that over half of the prescribed and over-the-counter (OTC) medicines for children contain sugar. Only one-third of the sugar-free medicines were labelled as such, and only one-quarter were stated to be sugar-free in the New Ethicals Catalogue. Recommendations for limiting caries in these children include: where possible, taking the medicine in tablet form; brushing with toothpaste or chewing sugar-free gum after taking the medicine; home and dental-office fluoride applications; where possible, taking medicines at meal-times rather than between meals; avoiding ingestion of the medicine before bed; and seeking regular preventive dental care. Awareness of the danger posed by these medications should be promoted among prescribers, pharmacists, manufacturers, regulatory authorities, and the public in order to bring about increased availability and use of sugar-free liquid medicines.

Administration, Oral↗
PubMed2002

The quality of conduct in Japanese clinical trials: deficiencies found in GCP inspections.

The quality of commercially sponsored clinical studies in Japan was examined with reference to deficiencies in the audit reports issued by the Organization for Pharmaceutical Safety and Research (OPSR). The OPSR is responsible for domestic good clinical practice auditing in Japan. Routine audits from 1997 to 2000 for 331 hospitals revealed various types of deficiencies such as errors in case report form (CRF) entries, institutional review board problems, and protocol deviations. The high prevalence of CRF-related deficiencies seemed to stem from peculiarities of the Japanese study environment such as the historical lack of on-site monitoring by the sponsor and the absence of research nurses. Characteristics in usual medical practices such as multiple drug use and loose informed consent also seemed to be associated with prevalence of similar deficiencies in clinical trials.

Clinical Trials as Topic↗
PubMed2002

On the commodification of the black female body: the critical implications of the alienability of fetal tissue.

Recent scientific experimentation has revealed that fetal tissue yielded from abortions has remarkable therapeutic value. This Note posits that the demand for fetal tissue likely will expand to the point where the current supply no longer satisfies it. Therefore, in order to obtain tissue from women who would not otherwise donate their abortuses, should research organizations, pharmaceutical companies, and doctors be allowed to offer women a "financial incentive" for their fetal tissue? That is, should women be allowed to sell their fetal tissue? This Note explores the question from a Critical Race Theory perspective. It analyzes the impact that a market in fetal tissue will have on Black women, who are more likely to participate in such a market due to their precarious economic situation, their higher abortion rate, and the effects of internalized oppression. The Note concludes that because Black women will be disproportionately exploited, as well as disenfranchised from the benefits produced by a market in fetal tissue, fetal tissue should not be made market alienable.

Abortion, Legal↗
PubMed1998

The Institute of Medicine's report on non-heart-beating organ transplantation.

In December 1997, the Institute of Medicine (IOM) released a report on medical and ethical issues in the procurement of non-heart-beating organ donors. This report had been requested in May 1997 by the Department of Health and Human Services (DHHS). We will here describe the genesis of the IOM report, the medical and moral concerns that led the DHHS to sponsor it, the process of producing it, and its conclusions. The analyses, findings, and recommendations of the report are also reviewed, in particular the central issues that led to suggestions for policy changes.

Cadaver↗
PubMed2004

"What's my DNA worth, anyway?": a response to the commercialization of individuals' DNA information.

Extensive enthusiasm surrounds the potential for human DNA information to sustain and enhance the pharmaceutical industry's profitability. Nevertheless, persons whose health makes their DNA of commercial interest are routinely expected simply to give their DNA and the information in it to pharmaceutical or genomics companies or their academic intermediaries, voluntarily and without compensation. This state of affairs is increasingly recognized as paradoxical, but it is favored by conventional bioethical opinion. Given that most DNA information is now collected for commercial purposes and is worth considerably more than is generally imagined, bioethical objections to compensation of individuals for their DNA information are inappropriate. This paper suggests approaches by which individuals and representative governments and patient interest groups can negotiate compensation. Appreciable attitudinal change is required if those individuals personally involved are to be included fairly in the commercialization of human DNA information. Ultimately, however, such change is necessary if commercial genetic research is to respect human dignity and human rights.

Bioethics↗
PubMed1998

The impact of reference pricing on clinical lipid control.

AIM: Reference pricing has recently been introduced into New Zealand in an attempt to curb rising pharmaceutical costs. Although budget savings may be significant, the resulting alteration of established drug prescriptions has the potential to cause harm. We undertook to assess the impact of these changes in patients switching from simvastatin to fluvastatin following the introduction of reference-based pricing in New Zealand. METHODS: The fasting lipid profiles of 262 patients in a defined geographic region were obtained after at least six weeks of fluvastatin therapy. These were compared to mean lipid levels obtained from laboratory databases for the patients while previously receiving simvastatin. RESULTS: There was a significant increase in total cholesterol, LDL cholesterol and triglyceride levels (p < 0.01). The elevation was less pronounced where higher incremental doses of fluvastatin were used, although still significant for LDL cholesterol and total cholesterol (p < 0.01). Those receiving maximal therapy with fluvastatin experienced similar elevations in lipid as did those on lower doses. CONCLUSION: The lipid elevations seen in this audit relate both to the lesser potency of fluvastatin and underdosing. In this high risk population, significant lipid elevations may conceivably produce an excess of vascular events. The responsibility to the taxpayer should be weighed carefully against the ethical responsibility to the individual patient and the potential to do harm. Subtherapeutic treatment may prove more costly than all the savings from reference pricing.

Drug Utilization↗
PubMed2006

Etomidate-Lipuro is associated with considerably less injection pain in children compared with propofol with added lidocaine.

BACKGROUND: Propofol is associated with a high incidence of injection pain in children, even if given together with lidocaine. A new lipid formulation of etomidate (Etomidate-Lipuro) has been found in adults to cause very little discomfort during i.v. injection. The aim of the present prospective, double-blind, randomized trial was to compare the incidence of injection pain during i.v. induction of anaesthesia between propofol with added lidocaine (previous standard) and this new etomidate formulation in paediatric patients. METHODS: A total of 110 paediatric patients, aged 2-16 years, scheduled for outpatient surgery were planned to be included in the study. The primary end point of the study was the incidence of injection pain during induction of anaesthesia as assessed by a four-point scale as described previously. The occurrence of myoclonic muscular activity was registered as a secondary end point (four-point scale). An interim analysis after 80 patients was requested by the Ethics' Committee. RESULTS: The study was stopped after the inclusion of 80 patients. A significantly lower incidence of injection pain was found in the Etomidate-Lipuro group as compared with the propofol-lidocaine group (5.0% vs 47.5%, P<0.001). The use of etomidate was associated with a significantly higher incidence of myoclonic activity compared with propofol-lidocaine (85.0% vs 15%, P<0.001). CONCLUSIONS: The use of a new lipid formulation of etomidate is associated with significantly less injection pain than propofol with added lidocaine in children. This finding may warrant a change in clinical practice in order to avoid unnecessary pain in children.

Adolescent↗
PubMed2006

The role of modern biology and medicine in drug development in academia and industry.

This symposium addresses careers in drug development in industry; the performance of translational research by academia, industry, and both; and numerous factors pertinent to alliances essential to drug discovery and development. Drug development is a complex process that regularly involves effective collaborations between academic and physician scientists and industry. There are specific occupational factors affecting recruitment of scientists and physicians in drug development programs in industry; ideal backgrounds for successful applicants for positions in industry in drug development; ethical and regulatory considerations particularly germane to the performance of scientists and physicians in drug development programs in industry and at universities; and particular gratifications available to scientists in industry working on drug development. Both similarities and differences characterize the performance of translational research in industry compared with academia. In industry, logistic, operational, and scientific oversight is complex, especially because it often involves relationships with clinical enterprises outside of the corporation. The process is long and arduous from formulation of a good idea in discovery to acceptance of a novel drug in the marketplace. Collaborations and partnerships by industry often involving academia and confrontation of multiple issues are pivotal.

Academic Medical Centers↗
PubMed1996

Computer-administered clinical rating scales. A review.

While clinician-administered symptom rating scales are the most commonly used outcome measures in pharmaceutical research, error variance due to poor inter-rater reliability increases the risk of type II errors in multi-center clinical trials. Such error variance could obscure true differences between active drug and placebo, or between two comparator compounds. Computer-administered versions of symptom rating scales originally designed to be administered by trained clinicians offer a solution to this problem. This paper reviews the empirical data on the reliability, validity and equivalence of computer-administered rating scales. Computer-administered versions of clinician-administered scales are now available for the assessment of depression, anxiety, obsessive-compulsive disorder, and social phobia. Validation studies support the reliability, validity and equivalence of these scales. Patient reaction has been positive, with patients generally more honest with and often preferring the computer for assessing sensitive areas such as suicide, alcohol or drug abuse, sexual behavior, or HIV related symptoms. Applications using Interactive Voice Response (IVR) technology facilitate longitudinal monitoring of patients without requiring office visits to collect data, increase the accessibility of information to the clinician, and the quality of patient care through more informed decision making. When used in accordance with established ethical guidelines, computers offer a reliable, inexpensive, accessible, and time-efficient means of assessing psychiatric symptoms.

Clinical Trials as Topic↗
PubMed1999

Pharmacists' concerns and perceived benefits from the deregulation of hormonal emergency contraception (HEC).

OBJECTIVE: To ascertain pharmacists' views, assess willingness for involvement and delineate individual perceived competence in the supply of deregulated hormonal emergency contraception (HEC). DESIGN: Cross-sectional postal questionnaire utilising closed, open and Likert-scale questions. SUBJECTS: Three thousand nine hundred and ninety-nine registered pharmacists abstracted from the mailing list of the Royal Pharmaceutical Society of Great Britain. RESULTS: In total 1543 (38.6%) questionnaires were returned and analysed. Overall 1165 (75.5%) of pharmacists stated their willingness to be involved in the deregulated supply of HEC. However, pharmacists identified the need for specific training before effective deregulation should take place. Overall, 616 (39.9%) of respondents felt individually competent to supply deregulated HEC with a positive association between perceived competence and willingness to supply deregulated HEC (p < 0.05). Pharmacists perceive the major benefits of deregulation to be a reduced unwanted pregnancy rate and a subsequent reduced abortion rate. They perceive that deregulation would allow quicker and less restricted access to HEC by clients, facilitating an increased overall supply of HEC. Pharmacists express a number of concerns, tempering their collective desire to see HEC deregulation. The majority of these concerns related to safeguarding clients and the possible adverse public health effects associated with the possible reduced use of barrier methods of contraception. CONCLUSIONS: Most pharmacists would be willing to supply HEC if it were deregulated to 'pharmacy only' from 'prescription only' medicine status. Although concerns were raised, these were mainly related to safety issues, with few pharmacists identifying moral and ethical barriers to deregulation. For effective deregulation to occur issues of professional competence need to be addressed.

Abortion, Induced↗
PubMed2003

Drug development and the heart hospital.

Conducting clinical trials to support the development of new pharmaceutical entities or devices offers specialized heart hospitals unique opportunities. The populations they serve with cardiovascular diagnoses provide a predictable reservoir for recruitment of patients into trials of cardiovascular drugs or devices. The later stages in new chemical entity development require hundreds to thousands of patients to achieve statistical power. This need provides opportunities for rapid screening and identification of patients who would potentially benefit from and be appropriate for study. Clinically sophisticated support personnel to facilitate the conduct of research trials are likely to be available in the staff structure of a heart hospital. Meticulous attention to patient safety and privacy, good clinical practice, and high-quality data collection are imperative.

Cardiac Care Facilities↗
PubMed1992

The publication of sponsored symposiums in medical journals.

BACKGROUND: An increasing proportion of spending by the pharmaceutical industry has gone to funding symposiums that are published by peer-reviewed medical journals. This study tests the hypothesis that such sponsorship, particularly by a single pharmaceutical company, is associated with a promotional orientation of the symposium and a distortion of the peer-review process. METHODS: We counted the symposiums published in 58 journals of clinical medicine and surveyed the journal editors regarding their policies for symposium issues. We analyzed the symposium issues that appeared in the 11 journals that published the most symposiums in order to determine the sponsor or sponsors, the topics, whether the titles were misleading, whether brand names were used, and whether the featured drugs were classified by the Food and Drug Administration as innovative or approved. RESULTS: The number of symposiums published per year increased steadily from 1966 through 1989. Forty-two percent of those analyzed (262 of 625) had a single pharmaceutical company as the sponsor. These symposiums were more likely than those with other sponsors to have misleading titles (P less than 0.001) and to use brand names (P less than 0.001), and less likely to be peer-reviewed in the same manner as other articles in the parent journal (P less than 0.001). Of the 161 symposiums that focused on a single drug, 51 percent concerned unapproved therapies; 14 percent concerned drugs classified as bringing important therapeutic gains. CONCLUSIONS: Symposiums sponsored by drug companies often have promotional attributes and are not peer-reviewed. Financial relations among symposium participants, sponsors, and journals should be completely disclosed, symposiums should be clearly identified, and journal editors should maintain editorial control over contributions from symposiums.

Congresses as Topic↗
PubMedDate not supplied

[Methodological analysis of phase IV clinical trials performed in hospital based on the Huriet Law ].

Since the implementation of the 'Huriet law', drugs in phase IV clinical trials are handled by the pharmaceutical Department of the 'Hôpital Neuro-Cardiologique' (Lyon, France). The methodology of these trials is assessed by using a special assessment grid which enables a score for each protocol, with a maximal score of 20 and a minimal one of minus 20. Although many limitations could be advanced, results of this study show that, among 39 assessed trials, 13 trials had weak methodology (score < or = 0), 16 are middle-quality trials (score between 0 and 10) whereas 10 trials only can be considered as having a strong methodology (score > 10). So, a fairly large number of the organized phase IV trials have debatable quality. Moreover, their objective is questionable, that is essentially promotional, in spite of the 'Huriet law' and Persons Protection Committees.

Clinical Trials, Phase IV as Topic↗
PubMed2005

The next pandemic: anticipating an overwhelmed health care system.

INTRODUCTION: In September 2005, an overview of current health care system planning efforts was presented to the audience at the Yale University Ethics Symposium on Avian and Pandemic Influenza. The speaker, also the author of this article, provided the audience with a summary of what was being undertaken with the use of federal preparedness funds to improve the overall infrastructure of the health care system. All of Connecticut's 31 acute care hospitals, the Veteran's Administration Hospital in West Haven, Hospital for Special Care, Gaylord Rehabilitation Hospital, Natchaug Psychiatric Hospital, and the state's 13 Community Health Centers are currently recipients of federal preparedness funds. Federal funding for this planning comes from Health Resources and Services Administration, Department of Health and Human Service's National Bioterrorism Hospital Preparedness Program. OBJECTIVES: This article outlines the planning activities around pandemic influenza that the state's health care system partners started in 2004-2005 and also those they are currently participating in or will be participating in the next 12 to 15 months. The article highlights the key objectives and strategies that health care facilities will be using in this planning. There are four major objectives that each health care facility's Emergency Operations Plan must address. They are: increasing bed availability, developing strategies to deal with the potential staffing shortages, developing strategies for dealing with potential critical equipment and pharmaceutical shortages, and, lastly, the implementation of education, training and communication strategies for their health care workers and the public they serve. These plans, and all the activities needed to operationalize the plans, such as education, training, drills, and exercises, will include their key partners, i.e., local health departments, local emergency management, police, fire, and Emergency Medical Services. This article will describe this work plan in detail. METHODS: Descriptive information was obtained through the author's observations and personal experiences, in addition to governmental guidance, reports, and plans. CONCLUSION: The "all-hazards" planning currently being undertaken by the key health care system partners in Connecticut as a result of federal funding for preparedness post 9/11 has fostered great working relationships between these entities and their local, regional, and statewide planning counterparts. Many of the specific grant dollars being provided to these facilities can assist in the planning that must be done for pandemic flu.

Connecticut↗
PubMed2006

Tissue distribution and pharmacodynamics: a complicated relationship.

With few exceptions, drugs exert their effects not within the plasma compartment, but in the defined target tissues. The process of drug distribution to the active site constitutes the "link-bridge" of the pharmacokinetic/pharmacodynamic (PK/PD) relationship. In spite of the importance of drug distribution as a key factor in determining pharmacologic response, research on drug distribution has historically received much less attention than that of absorption, metabolism, and excretion. The negligence of research on drug distribution is due mainly to the inaccessibility of the target tissues for obvious ethical reasons. In addition, lack of reliable experimental tools to assess the distribution process is also a major contributing factor. Because of this negligence, drug distribution has been referred to as "the forgotten relative in clinical pharmacokinetics." Although recent advances in molecular biology have led to the identification of many drug transporters, many of the processes of drug distribution are still not fully understood. The primary aim of this article is to provide new insight into the mechanisms of drug distribution, with an attempt to describe the relationship between the drug distribution and pharmacologic response. In addition, the factors that affect the processes of drug distribution will also be reviewed. Also, validity of some key assumptions that are used to relate the processes of tissue distribution with pharmacologic activity will be discussed.

Animals↗
PubMed2000

[The ANMCO (National Association of Hospital Cardiologists) in a changing health care system. Consensus development of the Organizing Symposium of the XXXI National Congress of Cardiology--ANMCO; Florence, May 21, 2000].

This year's symposium, while following the 30-year-old tradition of Organizational Symposia which have become a trademark of the National Association of Hospital Cardiologists (ANMCO) annual meetings, is characterized by a novel approach in terms of method and content. Prompted by the profound changes affecting the socio-cultural, organizational and economic context in which the Health Service operates, the Board of the Association decided to invite the community of hospital-based cardiologists to reflect on and make proposals concerning a number of leading topics not strictly related to the organization of hospital-based cardiology, but of a wider relevance pertaining to the whole issue of the relationship between a Scientific Society and the other components of the Health Service: national and regional institutions, other doctors, the lay public and the pharmaceutical industry, etc. The main aim of this exercise was to stimulate the Society to adapt to a changing environment and so render it more capable of effectively fulfilling its duties. Naturally the larger the consensus regarding the strategies to adopt the greater this efficacy will be. Out of the many possible subjects, four were chosen as preeminent: 1. ANMCO and research: what fields of research should be prioritized, and with what kind of internal organization, and external relations? 2. ANMCO and professional training: what should be the professional standards governing the cardiologist in a changing society, what strategies for continuing education and institutional accreditation? 3. ANMCO and the community-based Health Service: the need to establish clear and efficient organizational relations with community-based cardiology and especially with general practitioners, in order to ensure that the health service is in tune with the real world, guarantee real continuity of care and reduce unnecessary hospital admissions; 4. ANMCO and the general population: how to support the citizen-user in the imperfect health-market, how to first inform the patient and then guarantee true freedom of choice, how to respect the values of the patient, transcending ideological limits and proposing organizational solutions and a return to ethical guidelines. In order to be able to approach topics of this importance and complexity with some probability of success it is fundamental that a proper consensus is reached among the cardiological community which formulates and attempts to carry out any proposed strategy. Working hypotheses designed by a minority of the Society, even if authoritative, and "imposed" on the majority are destined to have a difficult and short life. These premises gave rise to the innovative method characterizing this Symposium: each of the four topics, once identified, was assigned to an expert member who produced a preliminary draft including some proposals. These drafts were circulated to all members of the Association some months prior to the conference, in order to allow for any new comments, proposals and criticisms. This interaction with the members allowed us to collect grass-root opinions which were then organized into their respective topics by one discussant for each topic, who acted as spokesman at the conference. During the Symposium the expert member for each topic summarized his proposals and initial thoughts (already known to all members) while the discussant represented the opinions of the members; finally each topic was open to debate. The last step of this complex procedure was a meeting of the symposium panel made up of the chairmen, speakers and discussants who drafted a consensus document representative of all the opinions discussed at the Symposium. What follows is the consensus document on the four chosen topics for the general information of all the members and for proposal to the Board of the Society who will take the executive decisions. Chapter 1. The speed with which technology is improving and medical knowledge increasing is creating a gap between biological research and clinical research and another gap between clinical research and its application in daily practice. The task any medico-scientific society must set itself is to bridge these gaps by integrating research and the diffusion of its results - i.e. training. ANMCO actively carries out both functions but lacks the organs which could produce far-reaching scientific research strategies. This document reports the aims and ways of resolving this structural problem. Chapter 2. Continuing medical education aimed at maintaining and developing the knowledge of a medical professional, represents a cultural requirement and now it has become a legislative duty also in Italy. During a symposium held on the occas

Cardiology↗