Editor's introduction.
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AIDS Serodiagnosis↗
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Results for “ETHICS, PHARMACEUTICAL”
Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.
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Drug supplies, management and manufacturing for local needs. The provision of pharmaceuticals by appropriate technology.
The provision of drugs is of much lower importance to poor communities than other health measures. However, partly because of the present imperfections of such measures, drugs are needed and methods of reducing their end cost and increasing their effectiveness are important, particularly for the poor rural patient. The field is acutely influenced by social, ethical and political forces but there are direct technical questions which those most in need are not in a position to answer. These have to do with the extent to which drug compounding can be decentralized and the availability of equipment and of manuals on simple handling techniques.
Developing Countries↗
Economic evaluations in the canadian common drug review.
The Canadian Common Drug Review (CDR) was established in 2003 to provide a single process for making formulary recommendations to most Canadian publicly funded drug plans. This paper considers the most common challenges faced by the CDR: (a) determining the effectiveness of a drug (particularly interpreting the importance of surrogate markers and changes in QOL measures); (b) the massive rise in the cost of new drugs, which, in general, does not seem to accompanied by a massive increase in effectiveness; (c) interpreting complex pharmacoeconomic evaluations which often do not provide straightforward answers about the cost effectiveness of a drug; (d) prescription creep (the tendency for drugs in the real world to be used in patients who were not studied in clinical trials, thus raising concerns about a drug's real-world cost effectiveness; and (e) ethical and societal issues, particularly the reimbursement of expensive drugs for rare diseases.
Canada↗
Open questions in bioequivalence.
Bioequivalence studies are mainly required to demonstrate the interchangeability of multisource pharmaceutical products, usually called generics. A pivotal investigation projected and conducted in compliance with specific guidelines allows a replicative company to register a generic drug via an ANDA (abbreviated new drug application) procedure. Serious problems are often encountered in planning and conducting these studies, which are not covered by operating guidelines, and call for protocols to be set up on a case-by-case basis. The main problems involve the high variability of some active ingredients, how to manage baseline with endogenous substances, drugs with a long terminal half-life, drugs under genetic polymorphic metabolism, drugs possessing stereogenic centre(s), and drugs which cannot ethically be given to healthy volunteers. These problems are extensively covered in this paper and, where appropriate, possible solutions are suggested.
Half-Life↗
Pharmaceutical sales representatives and the doctor/patient relationship.
As marketing efforts by drug companies become more aggressive, physicians are being asked to provide clinical "preceptorships" to pharmaceutical sales representatives. During a "preceptorship" of this type, the company representative spends a day with the physician seeing patients "as an educational experience," and the physician receives an "honorarium" from the drug company in return. We explore the implications of this practice. First, we examine the nature of the doctor/patient relationship and the fiduciary obligations incumbent upon physicians in their role as healers. Second, we examine four interlocking ethical principles-nonmaleficence, beneficence, respect for patient autonomy, and justice-that should govern doctor/patient encounters. Third, we critique several hypothetical scenarios involving individuals who might put forth a claim to enter the doctor/patient relationship (ie, a pharmacist, a social scientist, the husband of the patient, and a pharmaceutical sales representative). We conclude that the practice of providing clinical "preceptorships" to pharmaceutical sales representatives is unjustifiable, is unethical, and should not be permitted.
Beneficence↗
Observations on ethical problems and terminal care.
Progress in medical diagnosis and therapy has raised new problems with far-reaching ethical implications. Medicine must remain a profession and not become a business. Textbooks must address ethical problems in the context of health care decisions and not restrict themselves to pathophysiology and practical therapeutics alone. The relative roles of the principles of autonomy, non-maleficence, beneficence, and justice must be balanced and appropriately applied to individual situations in biomedical ethics. When therapy becomes futile and the suffering of the patient does not justify any anticipated benefit, the patient (and/or patient surrogate) may request withholding or even withdrawing life-prolonging interventions. In the persistent vegetative state, even nutritional support by an unnatural (tube) route may ethically be denied at the patient's (or surrogate's) informed decision. New areas of ethical evaluation have been raised by the desire of some individuals to prolongation of their lives at high expense to the society such that other individuals are denied services because of limitation of available resources. There has been a long-standing conflict of interest between the acceptance by physicians and/or medical institutions of money or gifts from pharmaceutical companies whose drugs they prescribe, stock, or sell. This practice increases the cost of the drugs and is, in effect, a "sick tax," which is morally wrong.
Beneficence↗
[Concerning the pharmaceutical industry's financing of post-graduate courses].
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Drug Industry↗
Essay on mercy killing reflects conflict on ethics for physicians and journalists.
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American Medical Association↗
The ethics of prescribing drugs.
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Abortion, Induced↗
AIDS, ethics, and ICUs.
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Acquired Immunodeficiency Syndrome↗
Coercion in the recruitment and retention of human research subjects, pharmaceutical industry payments to physician-investigators, and the moral courage of the IRB.
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Clinical Trials as Topic↗
A physician charter on medical professionalism: a challenge for medical education.
The European Federation of Internal Medicine, The American College of Physicians-American Society of Internal Medicine, and the American Board of Internal Medicine recently developed a Charter on Medical Professionalism that they hope will be accepted by physicians around the world. The charter is based on three principles: the primacy of patient welfare, patient autonomy, and social justice. We believe that each of these principles has relevance to medical education and practical implications. Based on the obligations of the charter, we believe that medical educators should consider the attribute of altruism in making admission decisions, enhance moral development in medical schools, develop a curriculum in quality improvement, explore further the use of patient simulation, and renew their efforts to incorporate knowledge of the basic sciences into clinical training. Furthermore, we believe they should ensure that students protect patient confidentiality, ensure role-model appropriate interactions with pharmaceutical companies, teach students how gender, race, and socioeconomic status have an impact on health care, require electives in underserved areas, and incorporate the charter into courses on medical ethics. Medical educators must also ensure that the curriculum and learning climate at their institutions support the values articulated in the charter.
Journal Article↗
Randomised controlled trials in Africa of HIV and AIDS: descriptive study and spatial distribution.
OBJECTIVES: To identify and describe randomised controlled trials on HIV and AIDS conducted in Africa and to map their spatial distribution using exact geographic coordinates. DESIGN: Construction and analysis of a database of trials conducted wholly or partly in Africa and reported before 2004. DATA SOURCES: CENTRAL, Medline, Embase, and LILACS. RESULTS: Our comprehensive search yielded 284 distinct records that were potentially eligible for inclusion in the database. Of these, 150 articles reported on 77 eligible trials published or reported from 1987 to 2003. Seven trials were identified exclusively from the CENTRAL database. Trials were conducted in 18 of 48 countries in sub-Saharan Africa. None were conducted in north Africa. Only 19 had a principal investigator located in an African country. Forty two trials assessed prevention and 35 assessed treatment. Most studies were funded by government agencies outside Africa (n = 43), with the pharmaceutical industry providing partial support to 16 of these. The pharmaceutical industry provided full or partial support to a further 18 trials. Only 43 trials reported conducting a power calculation for determining sample size. There was no mention of ethical approval or informed consent in 19 and 17 trials, respectively. CONCLUSION: The relatively small number of HIV/AIDS trials conducted in Africa is not commensurate with the burden of disease. Geographical mapping as an adjunct to prospective trial registration is a useful tool for researchers and decision makers to track existing and future trials.
Africa↗
A therapeutic area review of oncology products and players.
This article reviews the dynamics of the oncology market and treatment trends and provides strategic guidance to those concerned with new product discovery and development. Cancer is the therapeutic area of highest potential, with an annual market value expected to be in excess of US 40 billion dollars in 2020. The global incidence of cancer cases is forecast to more than double over the next 20 years. Investments in research and development will keep pace with the growing demand for effective treatments, aiming to fulfil the many and often discrete unmet medical needs. Recent breakthroughs promise more successful outcomes, particularly with the advent of more selective chemotherapy and novel therapeutic approaches. Among the latter, a number of angiogenesis inhibitors and monoclonal antibodies (mAbs) should show encouraging levels of efficacy by 2004. Oncology is a complex and high-risk therapeutic area that offers high rewards. It is appropriate for only the stronger or more focused serious players within the pharmaceutical industry. The winners will be the companies with a long-term strategic intent, a credible portfolio and engagement in appropriate alliances, particularly in discovery. The future presents ethical, clinical and commercial challenges, given the wide disparity of therapeutic outcomes among cancer patients around the world. The real success will thus be to treat cancer in innovative ways that benefit everyone and are, in volume and across the life cycle, commercially attractive to the treatment provider.
Journal Article↗
[Argentina, Brazil and Mexico. Biomedical research and the defense of a single standard of attention in developing countries].
In the Helsinki Declaration, which established the ethical principles for research with human subjects, article 5 states, "...concern about the well-being of human beings should always come before the interests of science and of society..." Research proposals should include this commitment, both in developed and developing countries. In countries like Argentina, Brazil and Mexico, much of the population experience situations of great injustice, including a lack of equal access to health care. In some cases, sectors of the pharmaceutical industry may see these deficiencies as offering opportunities for carrying out research and achieving economic profits, something which carries the risk of perpetuating and even intensifying the unjust situations and violations of human rights--these population groups already suffer from. This situation implies the need for commitment to and ethical reflection upon human rights related to health. Agreements are needed between the actors involved in health research: sources of funding, researchers, public policy makers, and the study subjects themselves, in order to protect the latter's rights, including continuity of medical treatment for research subjects, when necessary.
Adolescent↗
Guidance for clinicians in discerning and comparing the price of pharmaceutical agents.
Discerning the price of a pharmaceutical agent is not as straightforward an exercise as might be imagined. The widely used average wholesale price is a misnamed figure that does not provide a consistent approximation of the cost of a drug at either the retail or hospital levels. While clinicians should consider the prices of medications when deciding on the agent to prescribe for both ethical and economic reasons, there is currently no comprehensive source of accurate drug prices. Unless and until such information is made available, prescribers are encouraged to consult dispensing pharmacists to learn of these costs.
Analgesics↗
Reproductive health. An ethical perspective.
There are a number of important ethical issues involved in the area of women's reproductive health care. Only a few of these could be covered in this short paper. Abortion is perhaps the most controversial issue of all and raises a number of ethical issues related to the rights of the woman versus the rights of the fetus. Since abortion is legal in the United States, the issue of the role of the obstetrician-gynecologist is discussed, particularly as related to the shortage of physicians willing to perform the procedure and the paucity of abortion training in obstetrics/gynecology residency programs. Other issues discussed include teen pregnancy, contraceptive research and pharmaceutical company contraceptive pricing strategies, high rates of maternal mortality in the developing world and human immunodeficiency virus and acquired immunodeficiency syndrome among women and children.
Abortion, Legal↗
Antiretroviral therapy for pregnant women.
Reproductive-age women constitute an increasing percentage of individuals infected with human immunodeficiency virus. As clinical management issues particular to pregnancy become increasingly common, they are also becoming increasingly complex. With the approval of new antiretroviral agents, monotherapy with zidovudine, although still standard for prevention of mother-to-child transmission of human immunodeficiency virus, has become inadequate therapy for treatment of the mother. Clinicians must now consider alternative therapeutic strategies in spite of a dearth of experience in the setting of pregnancy. To facilitate optimal drug treatment of human immunodeficiency virus-infected pregnant women while maintaining a focus on prevention of transmission, we reviewed Medline, Reprotox, personal files, and pharmaceutical industry information about the antiretroviral agents currently approved. After summarizing potential beneficial and detrimental effects in both the pregnant and nonpregnant individual, we suggest clinical strategies and discuss the ethical and legal principles that should guide therapeutic decisions in pregnancy.
Anti-HIV Agents↗