Showing posts with label ethics. Show all posts
Showing posts with label ethics. Show all posts
Monday, May 21, 2012
Wednesday, March 28, 2012
Tuesday, March 27, 2012
open access: ecancer - Phase 0 clinical trials: towards a more complete ethics critique
Phase 0 clinical trials: towards a more complete ethics critique
Summary
In efforts to modernise the entire
drug-development process, making it more efficient, less costly, and
ultimately of real benefit to patients, The Federal Drug Administration
(FDA) authorised the use of exploratory IND or early Phase I (Phase 0)
studies. Quite different in structure from Phase I, II, and III studies,
the Phase 0 construct understandably poses a set of ethical problems
not seen in the other research phases and so far not adequately
addressed by ethicists. In an effort to deal with this deficiency, this
paper proposes an ethics critique, based not on the usual concept of
benefit, but on the means–end relation, and placed within an ethic of
science derived from the practice of science.
To date, the ethics analysis of Phase 0 clinical trials has remained incomplete [1–3].
Focusing, for the most part, on the Phase 0 construct itself, the
analysis has neglected the larger economic context in relation to which
Phase 0 trials must be understood for any complete analysis.......
"The Ethics of the Phase 0 Construct
It is clear from the way the Phase 0 construct is described in both the Critical Path Initiative and the Guidance that the FDA is promoting it as a means to achieve an end, namely, solving the “pipeline problem”. If so, then an ethics assessment of the construct should start by asking whether the end justifies the means in moral terms.......
"The Ethics of the Phase 0 Construct
It is clear from the way the Phase 0 construct is described in both the Critical Path Initiative and the Guidance that the FDA is promoting it as a means to achieve an end, namely, solving the “pipeline problem”. If so, then an ethics assessment of the construct should start by asking whether the end justifies the means in moral terms.......
Canadian Medical Association Journal: Consent requirements for pelvic examinations performed for training purposes
Blogger's Note: to read full article subscription required ($$$), see blog for numerous past posts on this (significant) womens' health issue
Canadian Medical Association Journal
ANALYSIS
In 2010, Canada’s two obstetrics and gynecology associations updated the policy statement concerning pelvic examinations performed on women under anesthesia. The previous guideline applied to medical students and residents, whereas the new one applies to medical students only. According to Gibson and Downie, pelvic examinations performed for training purposes presumably constitute a battery in law, subject to defence of consent. They argue that either the statement needs to be revised to include residents or a new statement specific to residents needs to be drafted. Full article (requires subscripiton $$$)
Wednesday, March 07, 2012
open access: Future Medicine - Ethical considerations for biobanking: should individual research results be shared with relatives?
Ethical considerations for biobanking: should individual research results be shared with relatives?
The issue of returning individual research results (IRRs) is important and contentious. Indeed, Science magazine calls this, “…the most pressing issue in genetics today” [1]. At stake are several significant concerns, including public trust in, and support for, biomedical research, the wise use of limited research resources and the ethical obligations of the research community.
This editorial briefly defends two important conclusions about these issues:
▪ The case for sharing IRRs with relatives is no stronger, and almost certainly weaker, than for donors;
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▪ The case for returning IRRs to donors is not particularly convincing.
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| Contrasting donors & relatives |
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The rationale for the first conclusion is straightforward. Outside of perhaps the general public itself, donors are the primary subjects to whom biobanks owe ethical consideration. Donors, not relatives, have explicitly (or, by not opting-out, implicitly) consented to their genetic materials being used by others. Donors’ interests are directly and powerfully affected by what happens in research. Their biological samples and health data reveal considerably more information about them than anyone else with whom they share partial genetic overlaps. Donors stand most fully and extensively to benefit from and/or be harmed by research. Hence, any obligations that biobanks have to donors’ relatives are weaker and narrower than to donors themselves.....cont'd
Wednesday, February 22, 2012
Monday, February 13, 2012
Do patients always get all of the information they need from their MD?
Do patients always get all of the information they need from their physician?
Posted by Gary Schwitzer in Health care/research ethics, Quality of care, Shared decision-making
Thursday, February 09, 2012
open access article: Human experiments: First, do harm : Nature News & Comment
Blogger's Note: a very good reminder on recognizing the actual 'end game' - the patients, obviously (not killing the patient in the process of a particular goal)
EVOLVING ETHICS
Sexually transmitted diseases (STDs) were a prime concern for health officials in the 1940s, and many medical studies — including the US experiments in Guatemala — used methods that would be considered unethical today. Although standards improved over the decades, clinical researchers continued to push the boundaries of acceptable science.....
Tuesday, February 07, 2012
(repost) Genomethics - background and Questionnaire UK
Questionnaire
This ethics and genomics study is being conducted by two Ethics Researchers. The team consists of:
Dr Anna Middleton, Ethics Researcher and Registered Genetic Counsellor,
and
Prof Mike Parker, Professor of Bioethics and Director of the Ethox Centre, University of Oxford
The two Ethics Researchers are part of the Deciphering Developmental Disorders (DDD) Study based at the Wellcome Trust Sanger Institute, Cambridge, UK. More information about the DDD study can be found here: www.ddduk.org
The DDD study involves a large team of scientists and informaticians and the Principal Investigators are:
- Dr Nigel Carter, molecular cytogeneticist, Wellcome Trust Sanger Institute, Cambridge, UK
- Dr Helen Firth, consultant clinical geneticist, Addenbrooke's Hospital, Cambridge, UK
- Dr Matt Hurles, molecular geneticist, Wellcome Trust Sanger Institute, Cambridge, UK
- Dr Jeff Barrett, statistical geneticist, Wellcome Trust Sanger Institute, Cambridge, UK
- Prof David Fitzpatrick, consultant clinical geneticist, Western General Hospital, Edinburgh, UK
- Prof Mike Parker, professor of bioethics, Director of Ethox, University of Oxford, UK
Friday, February 03, 2012
Tuesday, January 24, 2012
open access: PLoS Medicine: Challenging Medical Ghostwriting in US Courts - eg. ethics, legal liabilities, patient harm.....
Introduction
"Complaints about the ethics of medical ghostwriting have increased in the last decade, but little has changed [1]–[14]....."Summary Points
- Despite growing concern about medical ghostwriting, pharmaceutical companies, universities, medical journals, and communication companies employing ghostwriters have thus far failed to adequately stem the problem. As a result, some commentators have proposed that legal remedies could be sought by patients harmed by drugs publicized in ghostwritten papers.
- In this Essay, we build on a recent analysis by Stern and Lemmens in PLoS Medicine to outline specific areas of legal liability.
- For example, when an injured patient's physician directly or indirectly relies upon a journal article containing false or manipulated safety and efficacy data, the authors, including guest authors, can be held legally liable for patient injuries.
- In addition, guest authors of ghostwritten articles published by Medicare- and Medicaid-recognized peer-reviewed medical journals used as clinical evidence for indications for off-label uses may be liable under the federal False Claims Act for inducing the United States government to reimburse prescriptions under false pretenses.
- Paying guest authors of ghostwritten papers may influence clinical judgment, increase product sales and government health care costs, and put patients at risk by misrepresenting risk-benefit. Therefore, both physicians and sponsor companies may be liable under the federal Anti-Kickback Statute.
- Although guest authors and pharmaceutical defendants may argue a First Amendment right to participate in ghostwriting, the US Supreme Court has firmly held that the First Amendment does not shield fraud.
Sunday, January 22, 2012
media: The price of your soul: How the brain decides whether to 'sell out' (ethics/religion/money....)
"..."Our experiment found that the realm of the sacred – whether it's a strong religious belief, a national identity or a code of ethics – is a distinct cognitive process," says Gregory Berns, director of the Center for Neuropolicy at Emory University and lead author of the study. The results were published in Philosophical Transactions of the Royal Society.
Sacred values prompt greater activation of an area of the brain associated with rules-based, right-or-wrong thought processes, the study showed, as opposed to the regions linked to processing of costs-versus-benefits......"
Sunday, August 28, 2011
genetics? patient safety? ovarian cancer survival? ethics? links & references - Survivors' Debate: The Past Decade in Ovarian Cancer 'CON' side of debate Sandi Pniauskas
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Tuesday, June 28, 2011
Friday, June 17, 2011
(from asco 2011) video: Dr Steven Joffe – Dana-Farber Cancer Institute, Boston - Ethics of early-phase clinical trials on ecancer tv. Cancer journal: online cancer news, clinical oncology research, cancer information and latest cancer studies - open access cancer journal: ecancermedicalscience
Ethics of early-phase clinical trials
Dr Joffe talks to ecancer tv at ASCO 2011 about the arguments around
patient recruitment and expectation management in early-phase clinical
trials.Tuesday, May 03, 2011
Wednesday, April 13, 2011
Sunday, March 20, 2011
Commentary MJA Insight: Henry Woo: Abuse of self-pay patient system widespread (ethics)
Note: sound familiar?
(to view subscribe(free)
"....Sadly, the abuse of the self-pay system is widespread in the NSW public hospital system. We may be aware that it is happening, but nothing will change unless patients complain, and this is hardly likely.
Surgeons who aren’t happy with this arrangement appear unwilling to come forward in fear of political retribution, professional isolation and stymied career progression.
If we were to abolish self-pay, would we risk throwing the baby out with the bathwater? We have to balance the risks to our professional standing, our inability to regulate this behaviour and the financial risks to those who can least afford it against the risk of removing patient choice.
I would like to see this practice abolished, but if we cannot speak out about this when it involves unethical behaviour, the balance is heavily tilted against ever eradicating the self-pay system in our public hospitals."
Friday, February 11, 2011
full free access abstract + full paper: Social and ethical implications of BRCA testing — Ann Oncol
Abstract:
"Oncologists are asked with increasing frequency to counsel their patients with respect to the medical, psychological and social repercussions of genetic testing for cancer susceptibility that may have been prescribed by physicians or carried out through direct-to-consumer tests. This article critically reviews the main ethical and social implications of BRCA testing, focusing on genetic responsibility and genetic discrimination. Genetic responsibility toward oneself and others is a highly debated implication of genetic testing for cancer predisposition that requires broad considerations of the boundaries between individual and community rights and a reappraisal of the notion of autonomy as relational. Physicians’ duty to warn ‘at risk’ relatives can be an ethical quandary, yet confidentiality is key to the patient–doctor relationship. Mutation carriers may be subject to different forms and degrees of genetic discrimination and many individuals at risk have forgone BRCA testing to avoid potential discrimination. The scientific and medical community, together with patients and the public, has actively engaged against genetic discrimination. The legislation in many countries now protects against genetic discrimination by insurance companies and employers. Legal and regulatory issues are not the final answer to discrimination and profound cultural changes are required to create understanding and acceptance of all differences...."
Wednesday, December 15, 2010
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