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PubMed1998

[Physician practice patterns and attitudes to euthanasia in Germany. A representative survey of physicians].

Growing life expectancy and increasing pharmaceutical and technical methods in medicine are leading to more and more discussions among the general population and among physicians as to whether methods to shorten the sufferings of mortally ill persons should be legalised further. In Australia 60% of physicians wish to be able to perform active euthanasia if this would be legal. In the Netherlands physicians do not commit an offence if they perform euthanasia on the basis of ethically consented rules. In the FRG the National Board of Physicians (Bundesärztekammer) still rejects any liberalisation concerning active euthanasia. However, little is known of the attitudes and behaviour of physicians concerning the questions of active and passive euthanasia. Sponsored by Gruner and Jahr publishers for a magazine "Stern" publication we conducted a representative study among physicians working in hospitals and their colleagues in free practices concerning this topic. Beginning with qualitative interviews with 50 physicians we tested the questionnaire developed and looked for the data production method best fitting for this difficult matter resulting in telephone interviews or a self-administered questionnaire. In the main study a representative sample of n = 282 physicians in free practices and n = 191 physicians in hospitals were interviewed. The response rates were 94% and 51% respectively. Analysis of non-responses did not indicate any bias. Half of the physicians think that a broader discussion on euthanasia is necessary, 34% disagree and 17% consider even a discussion already dangerous. 6% of the physicians in hospitals and 11% in free practices have already experienced methods of active euthanasia. Half of the physicians have seen patients who strongly wished euthanasia, a situation which happens once in every two years. The majority of physicians feel a deep understanding but only a minority of 4% comply with the wish. The vast majority of physicians advocate indirect euthanasia. However, they experience difficulties in defining the difference between active and passive euthanasia in a concrete situation. Summing up, our data indicate that a broader and open discussion on euthanasia seems necessary even if this discussion in Germany will be even more difficult than in other countries due to our recent past. The discussion will be reopened by a proposal on guidelines concerning euthanasia launched by the German National Board of Physician

Aged↗
PubMed1998

Somatic gene therapy. Present situation and future perspective.

The ultimate goal in the management of inherited as well as acquired diseases is a rational therapy with the aim to eliminate the underlying biochemical defects, rather than a symptomatic treatment. Among other approaches somatic gene therapy is a promising candidate to meet these objectives and appears to have the potential to revolutionize modern medicine. Gene therapy is characterized by the transfer of genetic information to a patient through the use of recombinant DNA technology. Several strategies for the treatment of monogenetic disorders as well as chronical diseases like cancer and AIDS have been used in various somatic gene therapy projects. So far, 329 clinical studies (phases I, I/II and II) with over 2500 patients have been initiated worldwide since 1989. No significant toxicity and adverse side effects have been observed. To allow efficient transfer of the therapeutic genes, a variety of gene delivery techniques have been developed based on viral and non-viral vector systems. For the success of this technology it is vital to achieve regulated and sustained expression of foreign genes in specific target tissues. This will be crucial for the widespread application of somatic gene therapy. So far none for the gene delivery systems is able to meet the requirements of safety, efficiency and specificity demonstrating that vector research will be an important focus in the development of optimized transfer methods. From a regulatory point of view pharmaceutical DNA-products can be regarded as drugs and are therefore subject to the same regulations. Human gene therapy must, however, be limited to manipulations affecting somatic, differentiated cells to prevent the transferred gene from being transmitted to the individual's descendants. Applications for the purpose of 'enhancement' and not for the treatment of diseases are also not acceptable. Under these prerequisites, somatic gene therapy does not raise any new ethical concerns and can be interpreted as a special form of an organ transplantation. A comparison of the different regulatory situations of gene therapy in Europe and the United States demonstrates that for the European countries a uniform regulation is desired. Today somatic gene therapy is still in its infancy. It will continue to be scientifically and technically challenging until simple and effective procedures will have been developed. Demonstration of its clinical efficacy especially in the long term will have to be the next step. Looking at the history of biotechnology and the success of the biotechnology industry that is now providing safe and efficient products from recombinant DNA-technology there is little doubt that gene therapy will become a successful treatment for various indications in the next decade. The purpose of this article is to review the current status of the development in somatic gene therapy.

Acquired Immunodeficiency Syndrome↗
PubMed2002

Conflict of interest from a Romanian geneticist's perspective.

This paper examines Romanian bioethics regulations for biomedical sciences, looking in particular at the genetics area as a source for conflict of interest. The analysis is focused on the organizational level, national regulations, the sources for generating conflicts of interest, and management of conflicts. Modern biotechnology and gene technology are among the key technologies of the twenty-first century. The application of gene technology for medical and pharmaceutical purposes is widely accepted by society, but the same cannot be said of the development and application of gene technology in agriculture and food processing. Because the use of a technology in the production and processing of food is regarded more sceptically than in the production of biomedical products, there can be areas of conflict in many cases when communication is undertaken about gene technology in the agro-food sector. Ethical concerns play an important factor in this, but a society's attitude to a developing technology is an amalgam of many effects which are beyond ethics as such. This paper contains a study carried out by the author for the Romanian Association for Consumer Protection about the attitudes of consumers towards genetically modified (GM) foods. This study revealed that in Romania more than 98% of consumers did not know anything about GM foods and frequently were confused about the definitions of these terms. In conclusion, it is necessary to say that there is a low level of knowledge regarding biotechnology in Romania and this is an important reason why there is neither public acceptance of gene technology products nor is there a rejection.

Animal Experimentation↗
PubMed1990

Clinical drug trials in Alzheimer disease. What are some of the issues?

Clinical drug trials in Alzheimer disease are underway in many locations throughout the world. That experience has uncovered a number of unique difficulties. In response, members of the Alzheimer's Association Medical and Scientific Advisory Board organized meetings with experts from the government, academia, private practice and the pharmaceutical industry. The issues are presented here along with some suggestions to facilitate planning and to avoid problems in future drug trials.

Age Factors↗
PubMed2006

Clinical trials bureaucracy: unintended consequences of well-intentioned policy.

BACKGROUND: As randomized controlled trials have become the 'gold standard' for medical research, a complex regulatory structure for the conduct of clinical trials has emerged. However, this structure has not been adequately assessed to ensure that regulations governing human subjects research actually produce the desired effects. PURPOSE: Our purpose is to identify some of the major shortcomings in the current regulatory system of human clinical trials oversight, and to propose some potential solutions to these problems. METHODS: We discuss the evolution of the current US regulatory environment and its application in the context of several widely-used drug therapies. RESULTS: Despite numerous randomized controlled trials, performed within a structure of extensive documentation and data collection, serious shortcomings in a number of pharmaceutical therapies were not detected until after the drugs were approved and widely adopted by clinicians. CONCLUSION: The current system of regulatory bureaucracy in clinical trials has led to an extremely expensive research paradigm that, in spite of complex systems of oversight and exhaustive data collection, cannot be shown to adequately ensure the integrity of the research process and the protection of human research subjects. Some parts of the system, including Research Ethics Review Boards, may not be well-suited to carrying out their core mission of overseeing research conduct, and other aspects of clinical trials regulatory structure, such as monitoring/auditing review and adverse event reporting, may constitute a waste of money and resources. Misdirected data collection and adverse events reporting divert valuable resources and hamper development of large, simple clinical trials powered to definitively answer important research questions. Careful scrutiny of the utility of current or proposed regulatory schemes is required to ensure the integrity of human subjects research and to enhance the effectiveness of research dollars.

Adverse Drug Reaction Reporting Systems↗
PubMed1980

The position of the pharmaceutical industry in the development of drugs for pediatric use.

There is broad agreement that drugs to be used by children should be evaluated in children. Dosage and side effect information, in particular, cannot be reliably extrapolated from data derived from studies in adults. Few problems are encountered in obtaining adequate studies in children of drugs such as antibiotics which have a high potential for use in the pediatric age group. A large number of drugs will have limited use in children. They should be studied in children but the relative scarcity of qualified investigators, the limited patient population available for study, and ethical considerations dictate that the studies will be completed long after studies are completed in adults. These drugs should be allowed on the market before pediatric studies are completed, but there should be a commitment by the sponsor to complete the studies so that all drugs used by children will have adequate directions for use.

Adolescent↗
PubMed1993

Impact of clinical trial protocols on patient care systems at the University of Texas M.D. Anderson Cancer Center.

Clinical trial protocols represent a significant component of the research program at the University of Texas M.D. Anderson Cancer Center. Currently, there are nearly 800 active protocols using more than 150 investigational drugs. Sponsors of these trials include the National Cancer Institute, numerous pharmaceutical companies, and a variety of other funding sources. Because of our large patient base, however, routine participation in cooperative groups is limited. The impact of clinical trial protocols on patient care systems is a growing concern that is addressed primarily by the Surveillance Committee at M.D. Anderson. Like many institutional review boards, this committee reviews all protocols and must grant approval before the activation of any clinical trial. The issues of medical ethics, including a risk-benefit assessment for research subjects, equitable patient selection, safeguards for economically disadvantaged populations, and the general requirements for informed consent, also fall under the purview of this board. For any comprehensive cancer center to succeed, it must have strong research programs that enhance treatment options for patients. The crisis in financing health care significantly threatens the viability of cancer research. Reimbursement for the related costs of individuals participating in clinical trials has become a battle ground for third-party payers. The resulting economic risk is shared by health care providers and patients. As a consequence, many cancer centers, including M.D. Anderson, have initiated an economic-impact analysis for protocols as a component of the review process. This analysis includes an estimation of the patient care costs compared to the funding allocated to support the research. Future research will include pharmacoeconomic analysis and other ways to relate the costs and outcomes of treatment protocols. In the interim, we must monitor reimbursement trends for patients enrolled in clinical trials closely and amend the informed consent process to include a discussion of potential economic risk or hardship to patients if insurance claims are denied. Cancer care providers, third-party payers, the federal government, and society at large must work together to address the funding of cancer research and patient care.

Cancer Care Facilities↗
PubMed2003

[Quo vadis cardiologia? Or: An nescis, mi fili, quantilla prudentia mundus regatur? (Pope Julius III)].

In order to recognize and to solve problems, a look in the future is essential despite many uncertainties. Besides sound bed side-teaching, the main aim in the education of the students should be to acquire self-responsiveness and an attitude of permanent learning. It is more than doubtful whether the high expectations of health politicians will be met to limit the cost of in-patient treatment by introducing diagnosis-related groups in combination with evidence-based medicine, as this method has several severe limitations in order to fulfill this duty. The new financial system based on diagnosis-related groups will be in favor of private investors compared to the government-dependent university hospitals. The changing population pyramid implies not only higher costs but in addition severe medical problems. Within the changing society, alterations in the patient's behavior are to be expected. Several factors will contribute to make the doctor's profession less attractive. In the developing countries a rapid increase in the non-communicative diseases, i.e., in coronary heart disease, has to be expected. Apart from the prolongation of life - especially during its terminal phase - it is mainly the allocation of resources between industrialized and developing countries which will determine the ethical discussion. Germany has lost its leading position of the 19th and beginning of the 20th century in medical sciences. This was based on the liberal university system introduced by Wilhelm von Humboldt. Several pioneering innovations of German cardiologists during the 20th century have not strengthened German industry - in contrast to the situation in the 19th century. The general conditions in Germany, which are not research oriented, have prompted the majority of the pharmaceutical firms to transfer their research activities into foreign countries. In addition Germany's cardiological research has lost basic sciences partners for clinically orientated basic research, as many institutes which formerly worked in the cardiovascular field, are now devoted to other specialties. Restrictive legal regulations--such as the law regulating working hours, anti-corruption laws and the new legal university framework--are not conducive to internationally competitive research. Creative and innovative research requires liberal general conditions and cannot be planed.

Cardiology↗
PubMed2002

The establishment of a network of European human research tissue banks.

This is a report of a workshop held on the establishment of human research tissue banking which was held in Levi, Finland 21-24 March 2002. There were 21 participants from 7 European countries. This meeting was attended by representatives from academia, research tissue banks and from the Biotech and Pharmaceutical Industries. The principal aim of the workshop was to find a way to progress the recommendations from ECVAM workshop 44 (ATLA 29, 125-134, 2001) and ECVAM workshop 32 (ATLA 26, 763-777, 1998). The workshop represented the first unofficial meeting of the European Network of Research Tissue Banks (ENRTB) steering group. It is expected that in the period preceding the next workshop the ENRTB steering group will co-ordinate the ethical, legislative and organisational aspects of research tissue banking. Key issues dealt with by the Levi workshop included the practical aspects of sharing expertise and experiences across the different European members. Such collaboration between research tissue banks and end users of such material seeks to ultimately enable shared access to human tissue for medical and pharmaco-toxicological research while maintaining strict adherence to differences in legal and ethical aspects related to the use of human tissue in individual countries.

Journal Article↗
PubMed2004

Prevention--early detection--treatment? All of the above, please!

A natural, healthy and transparent relationship between the medical community and pharmaceutical and other medicinal industry has long been needed and requested by all involved: professionals, producers, health officials, the press, and society. Like in other areas of medicine, a thorough diagnosis of the condition, appropriate treatment of the afflicted, and effective prevention should be sought.

Drug Industry↗
PubMed2000

[Good clinical practice:impediment of source of progress?].

On the bases of the Declaration of Helsinki (1964), the law called Huriet-Sérusclat (1988) and several subsequent decrees have clearly defined the appropriate organization and management of clinical trials in France. The law on the Commission de l'informatique et des libertés (1978) and several European regulations have also to be taken into account. This extensive legal and regulatory system has been the source of a major improvement in the scientific quality of clinical trials and in the security of participating persons. Indirectly, it has also improved daily clinical care, as physicians have learned how to inform their patients and have been trained to use protocols and standard operative procedures. However, the legal and regulatory pressure has increased the cost and complexity of trials to such an extent that no clinician with his own resources is now able to be the sponsor of a trial involving more than a few patients. In addition to trials organized by pharmaceutical companies for drug development, health authorities in France and Europe should consider to support major clinical trials on therapeutic strategies with public health implications. A few examples can be acknowledged thus far, but a real policy remains to be defined.

Clinical Trials as Topic↗
PubMed2005

[Information about drugs from physicians and pharmacists].

Good quality information is essential for those who prescribe, deliver or use medications. This information should meet quality criteria: it should be evidence based, practice oriented, easy to find and topical. Pharmacists and physicians receive information from different sources and of valable quality. Initiatives should be taken to improve the quality. The authorities should stimulate these initiatives, and make sure that the information is evidence based. Medical schools and pharmacy schools should educate the students in these matters, and play a role in the continuing medical education thereabout. Opinion leaders should be aware of their responsibility. Existing initiatives should be expanded, and should be coordinated. Finally, there is the ethical obligation for health professionals to remain informed. One wonders in how far incentives (or even coercive measures) are necessary. There is a task there for the "Orders" of physicians and pharmacists, and the scientific and professional bodies.

Drug Prescriptions↗
PubMed2002

Design, analysis and presentation of multinational economic studies: the need for guidance.

Over the last decade, there has been a proliferation in the number of economic evaluations of pharmaceuticals to meet the growing demand for information about the economic benefits of healthcare technologies. The majority of these studies have been commissioned by pharmaceutical companies for the purposes of drawing attention to the resource and quality-of-life aspects of new or existing products. Such information has become important in overcoming a new obstacle, namely the demonstration of cost effectiveness (the so-called 'fourth hurdle'), in addition to the three well-established criteria of quality, tolerability and efficacy. To ensure the maintenance of standards, guidance for economic evaluations has emerged lately in the form of guidelines, regulations, principles, policies and positions. Drummond outlined three purposes of these guidelines, as follows: as a requirement prior to reimbursement, as statements of methodological standards, and as a statement of ethical standards. Such guidelines are designed to assist both the economic analyst and the decision-maker. In laying out the state of the art regarding the methodology of economic evaluation, guidelines assist the analyst in performing high-quality, scientifically valid studies, and assist the decision-maker in properly interpreting and assessing their quality. In response to these growing requirements for cost-effectiveness data globally, it has become increasingly common for economic evaluations to be conducted on an international scale. However, the recommendations in pharmacoeconomics guidelines regarding the manner in which these multinational economic evaluations should be designed, analysed and presented are too limited to be of any real value. This article examines the various issues that must be taken into consideration when conducting multinational studies, and provides a review of the techniques and approaches that have been suggested to date. It concludes with recommendations for potential inclusion in future sets of pharmacoeconomic guidelines.

Drug Costs↗
PubMed1991

Considerations regarding the development of individual nonclinical test strategies in the European Community.

The wish of pharmaceutical companies to be given the most binding possible preclinical test programmes for a new product, and the tendency of authorities to regulate to a great extent the preclinical testing of new drugs (especially at a multinational level), has led to differing requirements and practices in preclinical testing in different areas of the world. These differing requirements and practices have of necessity brought in their wake varying scientific criteria, with particular regard to animal protection, ethical standards, as well as imposing apparently unjustified extra financial costs. In order to improve this situation, the development of drug-specific preclinical test strategies is proposed in a drafted E. C. Note for Guidance, which incorporates already existing drug-testing guidelines and method recommendations. This draft Note for Guidance points to general methods of analysing problems and reaching decisions and thus appears to be worthy of recommendation as practical and desirable. It requires the co-operation of drug producers and supervisory authorities at a high scientific and ethical level. With regard to the state-of-the art and the socio-political background, the fulfillment of these requirements would appear not only to be appropriate but also imperative. To put them into practice would contribute enormously to the improvement of drug development and to de-emotionalization of the public debate. Therefore, comments on these draft guidelines from societies and associations are urgently sought and awaited with keen interest.

Animals↗
PubMed2006

Pharmaceutical research: paradox, challenge or dilemma?

A great deal of pharmaceutical research is nowadays carried out in developing countries such as Pakistan. Is it, however, beneficial for the country and the participants, often the poorly educated and illiterate? Pharmaceutical research in Pakistan can bring benefits to both patients and country. Promotion of good clinical practice and the development of national guidelines are advocated. Government and industry both have a role to play to maintain the right balance.

Benchmarking↗
PubMed2005

Supplemental standards of ethical conduct and financial disclosure requirements for employees of the Department of Health and Human Services. Interim final rule with request for comments.

The Department of Health and Human Services, with the concurrence of the Office of Government Ethics (OGE), is amending the HHS regulation that supplements the OGE Standards of Ethical Conduct. This interim final rule specifies additional procedural and substantive requirements that are necessary to address ethical issues at the National Institutes of Health (NIH) and updates nomenclature, definitions, and procedures applicable to other components of the Department. The rule: Revises the definition of a significantly regulated organization for the Food and Drug Administration (FDA); Updates the organization titles of designated separate agencies; Amends the gift exception for native artwork and craft items received from Indian tribes or Alaska Native organizations; Aligns the FDA prohibited holdings limit with the de minimis holdings exemption in OGE regulations; Revises prior approval procedures for outside activities; and, subject to certain exceptions: Prohibits NIH employees from engaging in certain outside activities with supported research institutions, health care providers or insurers, health-related trade or professional associations, and biotechnology, pharmaceutical, medical device, and other companies substantially affected by the programs, policies, or operations of the NIH; Bars NIH employees who file a public or confidential financial disclosure report from holding financial interests in substantially affected organizations; Subjects NIH non-filer employees to a monetary cap on holdings in such organizations; Specifies for NIH employees prior approval procedures for and limitations on the receipt of certain awards from outside sources; and Imposes a one-year disqualification period during which NIH employees are precluded from official actions involving an award donor. In addition, the Department is adding a new supplemental part to expand financial disclosure reporting requirements for certain outside activities and to ensure that prohibited financial interests are identified.

Awards and Prizes↗