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PubMed2001

Current issues in clinical research and the development of new pharmaceuticals.

As a normal part of the drug development process, U.S. pharmaceutical companies conduct many thousands of clinical trials each year. Only after a reasonable assurance of safety is made can the drug be given to patients who have the underlying medical condition that the drug is designed to treat. Patient welfare is assured by adhering to the Food and Drug Administration's interpretation of the "common rule" if the data will be used to support a licensing application. 21 CFR Part 50 sets forth the regulations along with the principles of informed consent and the use of institutional review boards (IRBs) that assure patients' rights are protected. Any potential conflict of interest on the part of a clinical investigator must be reported to the FDA. Pharmaceutical companies extensively monitor ongoing clinical trials for compliance with appropriate regulations. The recent revision of the Declaration of Helsinki governing placebo-controlled clinical trials may adversely impact drug development.

Advisory Committees↗
PubMed1998

Cryptolepis sanguinolenta: an ethnobotanical approach to drug discovery and the isolation of a potentially useful new antihyperglycaemic agent.

Evidence has been published that a wide array of plant-derived active principles, representing numerous classes of chemical compounds, demonstrate activity consistent with their possible use in the treatment of patients with Type 2 diabetes mellitus (DM). Despite these interesting observations, to date, metformin is the only ethical drug approved for treatment of Type 2 DM derived from a medicinal plant. Why is this so, given the fact that higher plants are such a potential source of new drugs? The answer to this rhetorical question may lie in the reliance of most pharmaceutical companies on random, in vitro, mechanism-based, high throughput screening in the initial phases of plant drug research. In this article we describe an alternative pathway to discovery of drugs for the treatment of Type 2 DM: on based on an ethnomedical approach, involving ethnobotany and traditional medicine. In particular, we present evidence that cryptolepine, an indoloquinolone alkaloid isolated from Cryptolepis sanguinolenta, significantly lowers glucose when given orally to a mouse model of diabetes. The antihyperglycaemic effect of cryptolepine leads to a significant decline in plasma insulin concentration, associated with evidence of an enhancement in insulin-mediated glucose disposal. Finally, cryptolepine increases glucose uptake by 3T3-L1 cells. These data permit us to conclude that an ethnobotanical approach to drug discovery can identify a potentially useful drug for the treatment of Type 2 DM.

Adipose Tissue↗
PubMed2004

A national survey on the effect of pharmaceutical promotion on medical students.

The pharmaceutical industry affects physicians' clinical decision-making, especially their prescribing behaviour. However, little is known of the interactions between medical students and the pharmaceutical industry. The purpose of the present study was to examine the extent and perceived influence of pharmaceutical promotion on Finnish medical students and students' attitudes towards such promotion. Altogether 952 students (34%) responded to an anonymous questionnaire that was distributed to all Finnish medical students at varying levels of study. Students reported that they attended presentations by pharmaceutical company representatives on a frequent basis. A total of 44% attended at least twice a month. Students regarded the pharmaceutical industry as one of their most important sources of pharmaceutical information. The importance attached to pharmaceutical promotion as a source of pharmaceutical information and the intensity of pharmaceutical marketing increased over the course of medical studies. Although most students were not in favour of reducing promotion, the students largely believed that such activities would affect their future prescribing behaviour, and the awareness of this influence increased over the course of studies. The fact that medical students are commonly exposed to pharmaceutical promotion should be addressed in medical education.

Attitude to Health↗
PubMed2002

Pharmacogenetic applications of the post genomic era.

The human genome sequence has given us the view of the internal genetic scaffold around which human life is molded. We have inherited this heritage from our ancestors and through it we are connected to all life on earth. The sequencing of the human genome, amongst others, has led to the newer areas of healthcare and medicine. The human population is heterogeneous and consists of populations of immense ethnic diversity. There are considerable allelic differences between human populations as well as individuals within each ethnic group as a result of molecular heterogeneity of the genome. This, in turn, is responsible for differential allelic expression of genes endowing them with polymorphic characters. The molecular diversity within genes is responsible amongst others, of disease resistance or susceptibility or for that matter drug response. The objective of this article is to understand the nuances of the genetic repertoire and correlate it with disease gene identification, genes that have been or can be used as drug targets, identify candidate genes for drug development and recent trends in drug discovery. As regular clinical trials for drugs does not take into account the ethnic variations, it sometimes results in the differential response with respect to the efficacy and/or adverse reaction of the drug. Therefore the diverse ethnic populations of the world pose a challenge to the pharma industry. The concept of the personal medicine seems to be the answer to this problem. But it is a Herculean task requiring immense innovation in technology, is time consuming and is not a financially viable proposition at this point of time. An alternate approach would be to divide the populations in genetic cohorts and design drugs according to their genetic profile and haplotype. In addition, the ethical and legal bindings have also to be taken into consideration.

Animals↗
PubMed1975

Food and Drug Administration regulations and licensure.

The regulatory requirements of the Food and Drug Administration for products that are defined as drugs and/or biologics are extensively documented in the applicable sections of the Code of Federal Regulations. They include broad requirements for good manufacturing practices and a number of general requirements for matters such as sterility, stability, pyrogens, and labeling. In addition, for biological products, specific standards are published for comment in the Federal Register and then as final rules prior to the acceptance of license applications for new products. The major criteria for such products are safety and effectiveness when the products are used prudently as directed in accompanying circulars. It is generally sound practice to obtain extensive toxicologic and pharmacologic knowledge of potential new products prior to embarking on clinical trials. These trials must be described in investigational new drug applications (INDs), if the products will be entered into interstate commerce. Clinical trials should be planned and conducted using sound scientific and ethical principles in order to obtain objective evidence of clinical effectiveness without unduly jeopardizing the participants in such studies.

Biological Products↗
PubMed2004

The pharmaceutical industry's responsibility for protecting human subjects of clinical trials in developing nations.

Pharmaceutical companies increasingly perform clinical trials in developing nations. Governments of host nations see the trials as a way to provide otherwise unaffordable medical care, while trial sponsors are drawn to those countries by lower costs, the prevalence of diseases rare in developed nations, and large numbers of impoverished patients. Local governments, however, fail to police trials, and the FDA does not monitor trials in foreign countries, resulting in the routine violation of international standards for the protection of human subjects. This Note proposes independent accreditation of those institutions involved in clinical trials--the institutional review boards which oversee trial protocol; the organizations, such as pharmaceutical companies, which sponsor the trials; and the research organizations that conduct the trials. Accreditation, similar to that used in the footwear and apparel industries, would increase the transparency of pharmaceutical trials and would enable the United States government and consumers to hold trial sponsors accountable for their actions.

Accreditation↗
PubMed2001

The new chimaera: the industrialization of organ transplantation. International Forum for Transplant Ethics.

Clinical organ transplantation has evolved through advances in patient care in parallel with investigations in associated biologies. It has developed from a cottage industry to an important medical specialty driven increasingly by the availability of newer and more effective immunosuppressive drugs, and dependent on consistently close collaborations between university-based clinical scientists and the pharmaceutical industry. Particularly during the past decade, however, this industry has undergone striking changes, consolidating into huge multi-national corporations, each competing for patients, their doctors, and for support of the allied hospitals. Because of the growth of "Big Pharma," the relationship between academia and industry has changed. There have been many advantages to such mutually dependent interactions. A combination of university-based expertise and the specialized knowledge and resources of industry have produced important scientific gains in drug development. Commercial sponsorship of applied research has been crucial. The orchestration of multicenter controlled clinical drug trials has provided invaluable information about the effectiveness of newer agents. But there are also disadvantages of increasing concern. Indeed, the power of "Big Pharma" in many medical fields including transplantation is such that presentation of data can be delayed, adverse results withheld, and individual investigations hampered. Clinical trials may be protracted to stifle competition. Monetary considerations may transcend common sense. Several measures to enhance the clinical relationship between the pharmaceutical industry and those involved with organ transplantation are suggested, particularly the use of third party advisors in the production of clinical trials, support for more basic research and in the dissemination of results. In this way, the increasingly problematic phenomenon of commercialization of the field of transplantation can be tempered and controlled.

Drug Industry↗
PubMed2005

The teaching of drug development to medical students: collaboration between the pharmaceutical industry and medical school.

Collaboration between the medical school at Leicester and a local pharmaceutical company, AstraZeneca, led to the design and implementation of an optional third year special science skills module teaching medical students about drug discovery and development. The module includes didactic teaching about the complexities of the drug discovery process leading to development of candidate drugs for clinical investigation as well as practical experience of the processes involved in drug evaluation preclinically and clinically. It highlights the major ethical and regulatory issues concerned with the production and testing of novel therapies in industry and the NHS. In addition it helps to reinforce other areas of the medical school curriculum, particularly the understanding of clinical study design and critical appraisal. The module is assessed on the basis of a written dissertation and the critical appraisal of a drug advertisement. This paper describes the objectives of the module and its content. In addition we outline the results of an initial student evaluation of the module and an assessment of its impact on student knowledge and the opinion of the pharmaceutical industry partner. This module has proven to be popular with medical students, who acquire a greater understanding of the work required for drug development and therefore reflect more favourably on the role of pharmaceutical companies in the UK.

Attitude of Health Personnel↗
PubMed1995

Observations on the rejection of physician-assisted suicide: a Roman Catholic perspective.

Roman Catholic moral theology follows a centuries-old tradition of moral reflection. Contemporary Roman Catholic moral theory applies these traditional arguments to the realm of medical ethics, including the issues of active euthanasia and physician-assisted suicide. Unavoidable moral limits on licit medical intervention sometimes require that the moral duty to treat cede to the duty to cease treatment when measures become more harmful than beneficial to the patient. This does not reduce the need for the compassionate use of palliative care in response to suffering. However, it does mean that rather than being excessively committed to maintaining mere biological human life, or actively seeking death, that we learn a sober realism about the limits of human life. Catholic moral analysis examines an act objectively, both in its relation to the agent and as a material event in the world. This allows both the virtuous or vicious intentions of the agent and the effects of the action to be included in its moral evaluation. Thus, Catholic moral analysis is both quasi-deontological and quasi-consequentialist. Objectively, active euthanasia and physician-assisted suicide, as acts of deliberate killing, are seen as repugnant, in that they fail to incarnate a benign inner intention or to form an agent in virtue. Catholic moral theology is extremely skeptical that an act of intending death directly can be consonant with a sincere compassion for the dying, suffering person and views it as a direct negation of the precious gift of human life.

Analgesia↗
PubMed1991

Sedation before ventilator withdrawal: can it be justified by double effect and called "allowing a patient to die"

... Recognizing that sedation and ventilator withdrawal have a causal impact on a patient's death does not open the door to active euthanasia but helps resist it by showing clearly where the debate centers. The heart of the euthanasia issue is not whether providers play a causal role in patients' deaths. They obviously often do when they withdraw burdensome or futile treatment or provide comfort, and these actions can be morally justified in appropriate circumstances. The key point is whether we can morally justify physicians playing two stronger causal roles: providing drugs and information for suicide and doing something in order to kill their patients. Before we can agree with those ethicists who argue that one can justify assisted suicide and active euthanasia despite the moral tradition that has shunned these causal roles, they must clearly show that the human good -- the good of the professions and of society at large, as well as the good of patients -- will be better served by physicians assisting in suicide and giving lethal injections....

Altruism↗