Bioethics and Medical Ethics Commons^™

Factors Influencing The One- And Two-Year Growth Response In Children Treated With Growth Hormone: Analysis From An Observational Study., Judith Ross, Peter A Lee, Robert Gut, John Germak

Department of Pediatrics Faculty Papers

To assess gender-, pubertal-, age-related differences in change from baseline height standard deviation score (ΔHSDS), data from 5,797 growth hormone (GH) naïve pediatric patients (<18 >years) with growth hormone deficiency (GHD), multiple pituitary hormone deficiency (MPHD), Turner syndrome (TS), small for gestational age (SGA), Noonan syndrome (NS), and idiopathic short stature (ISS) were obtained from the ANSWER (American Norditropin Studies: Web-enabled Research) Program registry. For patients with SGA, ΔHSDS at year 1 was significantly greater for males versus females (P = .016), but no other gender differences were observed. For patients with GHD, ΔHSDS was greater in prepubertal than in …

A Parent's Choice V. Governmental Regulations: A Bioethical Analysis In An Era Of Preimplantation Genetic Diagnosis, Michael Gortakowski

Buffalo Public Interest Law Journal

No abstract provided.

The Intellectual And Moral Integrity Of Bioethics: Response To Commentaries On "A Case Study In Unethical Transgressive Bioethics: 'Letter Of Concern From Bioethicists' About The Prenatal Administration Of Dexamethasone"., Laurence B Mccullough, Frank A Chervenak, Robert L Brent, Benjamin Hippen

Department of Pediatrics Faculty Papers

In our target article we showed that the Letter of Concern (LoC) fails to meet accepted standards for presenting empirical data for the purpose of supplementing a normative claim and for argument-based normative ethics. The LoC fails to meet the standards of evidence-based reasoning by making false claims, failing to reference data that undermine its key premises, and misrepresenting and misinterpreting the scientific publications it selectively references. The LoC fails to meet the standards of argument-based reasoning by treating as settled matters what are, instead, ongoing controversies, offering “mere opinion” as a substitute for argument, and making contradictory claims. The …

A Case Study In Unethical Transgressive Bioethics: "Letter Of Concern From Bioethicists" About The Prenatal Administration Of Dexamethasone., Laurence B Mccullough, Frank A Chervenak, Robert L Brent, Benjamin Hippen

Department of Pediatrics Faculty Papers

On February 3, 2010, a "Letter of Concern from Bioethicists," organized by fetaldex.org, was sent to report suspected violations of the ethics of human subjects research in the off-label use of dexamethasone during pregnancy by Dr. Maria New. Copies of this letter were submitted to the FDA Office of Pediatric Therapeutics, the Department of Health and Human Services (DHHS) Office for Human Research Protections, and three universities where Dr. New has held or holds appointments. We provide a critical appraisal of the Letter of Concern and show that it makes false claims, misrepresents scientific publications and websites, fails to meet …

The Perils Of The Imperfect Expectation Of The Perfect Baby., Frank A Chervenak, Laurence B Mccullough, Robert L Brent

Department of Pediatrics Faculty Papers

Advances in modern medicine invite the assumption that medicine can control human biology. There is a perilous logic that leads from expectations of medicine's control over reproductive biology to the expectation of having a perfect baby. This article proposes that obstetricians should take a preventive ethics approach to the care of pregnant women with expectations for a perfect baby. We use Nathaniel Hawthorne's classic short story, "The Birthmark," to illustrate the perils of the logic of control and perfection through science and then identify possible contemporary sources of the expectation of the perfect baby. We propose that the informed consent …

Teratology Primer-2nd Edition (7/9/2010), Sura Alwan, Steven B. Bleyl, Robert L. Brent, Christina D. Chambers, George P. Daston, Elaine M. Faustman, Richard H. Finnell, F. Clarke Fraser, Jan M. Freidman, Adriane Fugh-Berman, John M. Graham, Jr., Barbara F. Hales, Deborah K. Hansen, Lewis B. Holmes, Ronald D. Hood, Robert J. Kavlock, Thomas B. Knudsen, Joseph Lary, Donald R. Mattison, Richard K. Miller, James L. Mills, Janine E. Polifka, Sonja A. Rasmussen, Bernard Robaire, John M. Rogers, Gary C. Schoenwolf, Anthony R. Scialli, Gary M. Shaw, Amar V. Singh, William Slikker, Jr., Ann P. Streissguth, Melissa S. Tassinari, Janet Uriu-Adams, Charles V. Vorhees, Elora J. Weringer

Department of Pediatrics Faculty Papers

Foreword:

What is Teratology?

“What a piece of work is an embryo!” as Hamlet might have said. “In form and moving how express and admirable! In complexity how infinite!” It starts as a single cell, which by repeated divisions gives rise to many genetically identical cells. These cells receive signals from their surroundings and from one another as to where they are in this ball of cells —front or back, right or left, headwards or tailwards, and what they are destined to become. Each cell commits itself to being one of many types; the cells migrate, combine into tissues, or …

Mid-Atlantic Ethics Committee Newsletter, Summer 2010

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Diversity, Democracy And Dialogue In A Human Rights Framework, Carol C. Gould

Center for the Study of Ethics in Society Papers

Papers presented for the Center for the Study of Ethics in Society Western Michigan University, November 3, 2009

Ethics, Empathy, And The Education Of Dentists, David A. Nash

Oral Health Science Faculty Publications

Professional education in dentistry exists to educate good dentists-dentists equipped and committed to helping society gain the benefits of oral health. In achieving this intention, dental educators acknowledge that student dentists must acquire the complex knowledge base and the sophisticated perceptual-motor skills of dentistry. The graduation of knowledgeable and skilled clinicians in dentistry is a necessary, but not sufficient, condition for ensuring quality oral health care. The further requirement is the commitment of graduates to applying their abilities with moral integrity: providing appropriate and quality care in their patients' best interest. Ultimately, good dentistry depends on individuals committed to treating …

Undue Pharmaceutical Influence On Psychiatric Practice, Lisa Cosgrove, Harold J. Bursztajn

Counseling, School Psychology & Sport Faculty Publication Series

Within the past few years, increasing concerns have arisen about the ways in which corporate sponsorship of clinical trials and continuing medical education activities may bias the information that is published and disseminated about the benefits and risks of medications. Questions have also been raised about the extent of industry influence on the American Psychiatric Association’s diagnostic and treatment guidelines—namely, its DSM and Clinical Practice Guidelines.

Cross-Sector Review Of Drivers And Available 3rs Approaches For Acute Systemic Toxicity Testing, Troy Seidle, Sally Robinson, Tom Holmes, Stuart Creton, Pilar Prieto, Julia Scheel, Magda Chlebus

Experimentation Collection

Acute systemic toxicity studies are carried out in many sectors in which synthetic chemicals are manufactured or used and are among the most criticized of all toxicology tests on both scientific and ethical grounds. A review of the drivers for acute toxicity testing within the pharmaceutical industry led to a paradigm shift whereby in vivo acute toxicity data are no longer routinely required in advance of human clinical trials. Based on this experience, the following review was undertaken to identify (1) regulatory and scientific drivers for acute toxicity testing in other industrial sectors, (2) activities aimed at replacing, reducing, or …

Calling On Science: Making “Alternatives” The New Gold Standard, Melvin E. Andersen

in Vitro Research Models Collection

All of life’s great journeys start with a goal in mind! The 2007 NAS report, Toxicity Testing in the 21st Century – A Vision and A Strategy, has proposed a clear goal. This report envisions a not-so-distant future where all routine toxicity testing for environmental agents will be conducted in human cells in vitro evaluating perturbations of cellular responses in a suite of toxicity pathway assays. Dose response modeling would utilize computational systems biology models of the circuitry underlying each toxicity pathway; in vitro to in vivo extrapolations would use pharmacokinetic models, ideally physiologically based pharmacokinetic models, to predict human …

An Updated History Of The Teratology Society., Thomas H Shepard, Mason Barr, Robert L Brent, Andrew Hendrickx, Devendra Kochhar, Godfrey Oakley, William J Scott, John M Rogers

Department of Pediatrics Faculty Papers

BACKGROUND: The 49-year history of the Teratology Society is reviewed. An abbreviated history is outlined in table form, with listings of the Warkany Lectures, the Continuing Education Courses, and officers of the society. The original article was updated to include the years 2000 to 2010.

METHODS: A year-by-year description of the events is given, including the scientific and social content of the annual meetings and changes in the business of the society, in many cases using comments from the past presidents. The valuable and unique diversity of the members is discussed and illustrated, presenting the disciplines and main research areas …

Attitudes Of Parents At Risk Of Inheriting Li-Fraumeni Syndrome To Wards Predictive Genetic Testing In Their Minor-Aged Children., Leslie A. Newman

Dissertations and Theses (Open Access)

Li-Fraumeni Syndrome (LFS) is a hereditary cancer syndrome which predisposes individuals to cancer beginning in childhood. These risks are spread across a lifetime, from early childhood to adulthood. Mutations in the p53 tumor suppressor gene are known to cause the majority of cases of LFS. The risk for early onset cancer in individuals with Li-Fraumeni Syndrome is high. Studies have shown that individuals with LFS have a 90% lifetime cancer risk. Children under 18 have up to a 15% chance of cancer development. Effectiveness of cancer screening and management in individuals with Li-Fraumeni Syndrome is unclear. Screening for LFS-associated cancers …

Reproductive Toxicology, Robert L. Brent

Department of Pediatrics Faculty Papers

Summary

1. WEC has many useful scientific purposes.

2. You cannot utilize WEC to label a drug or chemical as a teratogen if the exposures utilized will result in embryonic or fetal death in vivo.

3. WEC can indicate that a drug or chemical is embryotoxic.

4. If the exposure level for clinical use of a drug or environmental exposure of a chemical is known, it should be used in WEC studies along with higher exposures as well.

5. You cannot predict that a drug is a cardiac teratogen from WEC when no cardiac malformations are observed, as in this …

Researchers’ Views On Ethical Challenges In Healthcare Cluster-Randomized Trials, Andrew Mcrae

Research Day (Arts & Humanities, FIMS, and Education)

• Cluster-randomized trials (CRTs) commonly used in education, public health, healthcare and social sciences
• Groups of individuals randomly assigned to receive one of 2 (or more) comparator interventions
• Effect of interventions evaluated after collecting data from individual group members
• Ethics guidelines developed for oversight of research enrolling individual subjects
• Little specific guidance for ethical conduct of CRTs
• Lack of guidance may lead to variability in ethics reviews between jurisdictions and over time

Conceptual Problems In Research Ethics, Charles Weijer

Research Day (Arts & Humanities, FIMS, and Education)

This poster addresses these issues:
• What good is medical research?
• What is owed to the study subject?
• When is research risk acceptable?
• How should we conduct research in developing countries?
• How should we conduct research involving communities?

Pharmaceutical Philanthropic Shell Games, Lisa Cosgrove, Harold J. Bursztajn

Counseling, School Psychology & Sport Faculty Publication Series

In response to increasing public distrust and congressional concerns regarding pharmaceutical company influence on medical research and education, professional organizations have taken steps to phase out or regulate industry-sponsored educational support. A related problem is industry funding of philanthropic organizations, such as patient advocacy groups. Thus, when the office of Sen Charles Grassley (R-Iowa) recently reported that the National Alliance for the Mentally Ill received substantial pharmaceutical funding, there was concern among the membership’s psychiatric patients and their families.

Update - March 2010, Loma Linda University Center For Christian Bioethics

Update

In this issue:

-- Glorifying God in Our Body: A Seventh-day Adventist Theological Foundation for Nursing
-- Editorial
-- New Beginning at the Center for Christian Bioethics

Toxicity Testing In The 21st Century: A Vision And A Strategy, Daniel Krewski, Daniel Acosta Jr, Melvin Anderson, Henry Anderson, John C. Bailar Iii, Kim Boekelheide, Robert Brent, Gail Charnley, Vivian G. Cheung, Sidney Green Jr, Karl T. Kelsey, Nancy I. Kerkvliet, Abby A. Li, Lawrence Mccray, Otto Meyer, Reid D. Patterson, William Pennie, Robert A. Scala, Gina M. Solomon, Martin Stephens, James Yager, Lauren Zeise

Experimentation Collection

With the release of the landmark report Toxicity Testing in the 21st Century: A Vision and a Strategy, the U.S. National Academy of Sciences, in 2007, precipitated a major change in the way toxicity testing is conducted. It envisions increased efficiency in toxicity testing and decreased animal usage by transitioning from current expensive and lengthy in vivo testing with qualitative endpoints to in vitro toxicity pathway assays on human cells or cell lines using robotic high-throughput screening with mechanistic quantitative parameters. Risk assessment in the exposed human population would focus on avoiding significant perturbations in these toxicity pathways. Computational systems …