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Biomedical subjects

Timothy Caulfield

Publications and source records attributed to Timothy Caulfield.

At least 19 recordsLinked to original sources
PubMed2006

Gene patents, health care policy and licensing schemes.

Human gene patents continue to stir social controversy, including the possibility that they might adversely affect public access to useful technologies. It has been suggested that a compulsory licensing policy might be used to alleviate the adverse effect of patents in this context. We suggest, however, that it is unclear whether existing international policies and licensing practices will permit compulsory licensing to be used in a way that would address common concerns. Indeed, given the minor role that genetic technologies have in most health care systems, it would be difficult to justify compulsory licensing. At a minimum, policy makers need to be more realistic about the potential effects of international trade agreements on the development of biotechnology policies.

Genetic Research↗
PubMed2006

Human dignity: a guide to policy making in the biotechnology era?

This article explores the ways in which human dignity is used in debates about controversial biotechnologies, including biobanks, human gene patents, stem cell research and human cloning. Increasingly, human dignity is used as a form of general condemnation and as blanket justification for regulatory restraint. However, this use of human dignity marks a significant departure from the traditional, human-rights informed view of human dignity that has dominated bioethics debates for decades. In addition, on its own, it stands as dubious justification for policies that are aimed at constraining controversial biotechnologies.

Bioethical Issues↗
PubMed2005

A systematic review of how homeopathy is represented in conventional and CAM peer reviewed journals.

BACKGROUND: Growing popularity of complementary and alternative medicine (CAM) in the public sector is reflected in the scientific community by an increased number of research articles assessing its therapeutic effects. Some suggest that publication biases occur in mainstream medicine, and may also occur in CAM. Homeopathy is one of the most widespread and most controversial forms of CAM. The purpose of this study was to compare the representation of homeopathic clinical trials published in traditional science and CAM journals. METHODS: Literature searches were performed using Medline (PubMed), AMED and Embase computer databases. Search terms included "homeo-pathy, -path, and -pathic" and "clinical" and "trial". All articles published in English over the past 10 years were included. Our search yielded 251 articles overall, of which 46 systematically examined the efficacy of homeopathic treatment. We categorized the overall results of each paper as having either "positive" or "negative" outcomes depending upon the reported effects of homeopathy. We also examined and compared 15 meta-analyses and review articles on homeopathy to ensure our collection of clinical trials was reasonably comprehensive. These articles were found by inserting the term "review" instead of "clinical" and "trial". RESULTS: Forty-six peer-reviewed articles published in a total of 23 different journals were compared (26 in CAM journals and 20 in conventional journals). Of those in conventional journals, 69% reported negative findings compared to only 30% in CAM journals. Very few articles were found to be presented in a "negative" tone, and most were presented using "neutral" or unbiased language. CONCLUSION: A considerable difference exists between the number of clinical trials showing positive results published in CAM journals compared with traditional journals. We found only 30% of those articles published in CAM journals presented negative findings, whereas over twice that amount were published in traditional journals. These results suggest a publication bias against homeopathy exists in mainstream journals. Conversely, the same type of publication bias does not appear to exist between review and meta-analysis articles published in the two types of journals.

Bias↗
PubMed2005

Policy conflicts: gene patents and health care in Canada.

Several recent gene patent controversies have energized and refocused the human gene patent debate in Canada. These include the use of the Myriad test for breast cancer by the provinces, patenting of the Severe Acute Respiratory Syndrome virus and a recent Supreme Court decision rejecting the patenting of 'higher life forms'. These cases place the emerging policy conflicts between the innovation and commercialization agenda of the government and the desire to provide equitable access to health care in sharp focus. Another challenge faced by Canada is the powerful influence of the United States in policy decisions. Although these issues have raised awareness about the possibility of reforming the patent system, Parliament has yet to consider any of the suggested reforms of the Canadian patent system and there are no formal proposals pending.

Animals↗
PubMed2004

Variations and voids: the regulation of human cloning around the world.

BACKGROUND: No two countries have adopted identical regulatory measures on cloning. Understanding the complexity of these regulatory variations is essential. It highlights the challenges associated with the regulation of a controversial and rapidly evolving area of science and sheds light on a regulatory framework that can accommodate this reality. METHODS: Using the most reliable information available, we have performed a survey of the regulatory position of thirty countries around the world regarding the creation and use of cloned embryos (see Table 1). We have relied on original and translated legislation, as well as published sources and personal communications. We have examined the regulation of both reproductive cloning (RC) and non-reproductive cloning (NRC). RESULTS: While most of the countries studied have enacted national legislation, the absence of legislation in seven of these countries should not be equated with the absence of regulation. Senator Morin was not correct in stating that the majority of recent legislation bans both RC and NRC. Recent regulatory moves are united only with regard to the banning of RC. While NRC is not permitted in seventeen of the countries examined, it could be permitted in up to thirteen countries. CONCLUSIONS: There is little consensus on the various approaches to cloning laws and policies, and the regulatory position in many countries remains uncertain.

Asia↗
PubMed2004

Biotechnology and the popular press: hype and the selling of science.

The popular media has emerged as an important source of scientific information. It has been suggested that the portrayal of genetics by the media is often inaccurate--a phenomenon branded 'genohype'--and, as a result, is having an adverse impact on public understanding and policy development. However, emerging data suggest that, in some circumstances, the media reporting of science is surprisingly accurate and portrays a message created by the scientific community. As such, there are reasons to believe that the hyping of research results might be part of a more systemic problem associated with the increasingly commercial nature of the research environment.

Biotechnology↗
PubMed2004

The regulation of science and the Charter of Rights: would a ban on non-reproductive human cloning unjustifiably violate freedom of expression?

Non-Reproductive Human Cloning (NRHC) allows researchers to develop and clone cells, including non-reproductive cells, and to research the etiology and transmission of disease. The ability to clone specific stem cells may also allow researchers to clone cells with genetic defects and analyze those cells with more precisions. Despite those potential benefits, Parliament has banned such cloning due to a myriad of social and ethical concerns. In May 2002, the Canadian Government introduced Bill C-13 on assisted human reproductive technologies. Bill C-13 deals with both the scientific and the clinical use of human reproductive materials, and it prohibits a number of other activities, including NRHC. Although the Supreme Court of Canada has never ruled on whether scientific experiments area form of expression, academic support exists for this notion. The authors go through the legal analysis that would be required to find that scientific experiments are expression, focusing in part on whether NRHC could be considered violent and thus fall outside the protection of section 2(b). The latter question is complicated by the ongoing policy debate over whether an "embryonic cell" is property of human life. The authors then consider whether a ban on NRHC could be justified under section 1 of the Charter. They conclude that both the breadth of the legislative purpose and the proportionality of the measure are problematic. Proportionality is a specific concern because the ban could be viewed as an outright denial of scientific freedom of expression. Although consistent with current jurisprudence on freedom of expression, this paper runs against the flow of government policy in the areas of regulation and prohibition of non-reproductive human cloning. As there has been no Charter litigation to date on whether scientific research is a form of expression, the authors introduce a new way of looking at the legality of the regulation of new reproductive technologies.

Biomedical Research↗
PubMed2003

Human cloning laws, human dignity and the poverty of the policy making dialogue.

BACKGROUND: The regulation of human cloning continues to be a significant national and international policy issue. Despite years of intense academic and public debate, there is little clarity as to the philosophical foundations for many of the emerging policy choices. The notion of "human dignity" is commonly used to justify cloning laws. The basis for this justification is that reproductive human cloning necessarily infringes notions of human dignity. DISCUSSION: The author critiques one of the most commonly used ethical justifications for cloning laws - the idea that reproductive cloning necessarily infringes notions of human dignity. He points out that there is, in fact, little consensus on point and that the counter arguments are rarely reflected in formal policy. Rarely do domestic or international instruments provide an operational definition of human dignity and there is rarely an explanation of how, exactly, dignity is infringed in the context reproductive cloning. SUMMARY: It is the author's position that the lack of thoughtful analysis of the role of human dignity hurts the broader public debate about reproductive cloning, trivializes the value of human dignity as a normative principle and makes it nearly impossible to critique the actual justifications behind many of the proposed policies.

Attitude↗
PubMed2003

DNA databanks and consent: a suggested policy option involving an authorization model.

BACKGROUND: Genetic databases are becoming increasingly common as a means of determining the relationship between lifestyle, environmental exposures and genetic diseases. These databases rely on large numbers of research subjects contributing their genetic material to successfully explore the genetic basis of disease. However, as all possible research questions that can be posed of the data are unknown, an unresolved ethical issue is the status of informed consent for future research uses of genetic material. DISCUSSION: In this paper, we discuss the difficulties of an informed consent model for future ineffable uses of genetic data. We argue that variations on consent, such as presumed consent, blanket consent or constructed consent fail to meet the standards required by current informed consent doctrine and are distortions of the original concept. In this paper, we propose the concept of an authorization model whereby participants in genetic data banks are able to exercise a certain amount of control over future uses of genetic data. We argue this preserves the autonomy of individuals at the same time as allowing them to give permission and discretion to researchers for certain types of research. SUMMARY: The authorization model represents a step forward in the debate about informed consent in genetic databases. The move towards an authorization model would require changes in the regulatory and legislative environments. Additionally, empirical support of the utility and acceptability of authorization is required.

Advance Directives↗