Bioethics and Subject Advocacy Program, Indiana CTSI
Indiana University Center for Bioethics
410 W 10th Street, Suite 3100
Indianapolis, IN 46202
Tel: 317-278-4034 | Fax: 317-278-4050
Contents
Local News and Announcements
Health Care Reform
Eric M. Meslin (IUCB director) and Aaron Carroll contributed to the nation’s focus on health care reform. Meslin participated in a public debate hosted by Smaller Indiana and also contributed to the Association of Bioethics Program Directors statement, “Three Myths about the Ethics of Health Care Reform.”
Among other media appearances, Carroll discussed health reform and the results of a new survey about government involvement in health insurance on Sound Medicine. On a related topic, IUCB also released a new survey report co-authored with Indiana University Center for Health Policy and Professionalism Research (CHPPR): Do Americans believe the “myths” about health care reform? Yes, they do.
Recent Papers and Presentations
Faculty Investigator, Katherine Drabiak-Syed presented “Revisiting the USPTO’s Examination Guidelines for Gene Patents: Congressional Inaction, USPTO Restraint, and Judicial Remedy” at the August 17, 2009 PredictER meeting.
As the research ethics community waits for President Obama to name a new national bioethics commission, Eric M. Meslin reflects on the history and role of the commissions in “Should bioethics commissions have more authority?” for Bioethics Forum (August 4, 2009).
Other new publications from the Center and its faculty investigators include:
Drabiak-Syed K. State codification of federal regulatory ambiguities in biobanking and genetic research. J Leg Med. 2009 Jul-Sep;30(3):299-327. PMID: 19681010
Sly PD, Eskenazi B, Pronczuk J, Srám R, Diaz-Barriga F, Machin DG, Carpenter DO, Surdu S, Meslin EM. Ethical issues in measuring biomarkers in children’s environmental health. Environ Health Perspect. 2009 Aug;117(8):1185-90.
Green RC, Roberts JS, Cupples LA, Relkin NR, Whitehouse PJ, Brown T, Eckert SL, Butson M, Sadovnick AD, Quaid KA, Chen C, Cook-Deegan R, Farrer LA; REVEAL Study Group. Disclosure of APOE genotype for risk of Alzheimer’s disease. N Engl J Med. 2009 Jul 16;361(3):245-54. PMID: 19605829
New Research Assistant
IUCB welcomes Kalli McBride as our new graduate, research assistant. Kalli is pursuing a dual degree (J.D., M.A.) in Law and Bioethics and will be working closely with our faculty on several programs.
Upcoming Events
Jennifer Girod and Andy Klein. Predictive Health and Toxic Torts. PredictER Meeting. August 31, 2009. 3:00 pm, Indiana University Center for Bioethics.
Richard Gunderman, MD, PhD. Healing as calling. Fairbanks Ethics Lecture Series. Noon. Methodist Petticrew Auditorium. September 2, 2009.
George Sledge and Pamela Perry. Physician and Patient Experience of Recurrent Cancer Treatment; Pharmacogenomics and Personalized Medicine. PredictER Meeting, September 21, 2009. 3:30 pm, Indiana University Center for Bioethics.
Fairbanks Ethics Lecture Series 2009-2010
History of Medicine Speaker Series, 2009-2010
PredictER Meetings, Fall Schedule 2009
Research Ethics in the News
Mitochondrial Gene Replacement
Researchers in Oregon have transferred DNA from the nucleus of one macaque monkey egg and deposited it in another egg prior to fertilization. The results? Baby macaques born free of inherited defects in mitochondrial DNA—including twins, Mito and Tracker. The full method is reported in August 26 online edition of the journal Nature. In the press release, one of the authors of the article, Shoukhrat Mitalipov, comments on a potential, future outcome:
In theory, this research has demonstrated that it is possible to use this therapy in mothers carrying mitochondrial DNA diseases so that we can prevent those diseases from being passed on to their offspring.... We believe that with the proper governmental approvals, our work can rapidly be translated into clinical trials for humans, and, eventually, approved therapies.
For better or for worse, the “proper governmental approvals” may have to wait for a not-so-rapid change in how the public (including many ethicists) weighs the benefits and risks of similar research with human subjects. Rob Stein in the Washington Post (Lab Produces Monkeys With 2 Mothers, August 27, 2009) provides a quick survey of what some well-known ethicists are saying about the research. Also, anticipating public concerns about the progress of this research, the editors of the journal Nature published a brief overview of the barriers to similar research with human subjects; see: Editorial. The ethics of egg manipulation. Nature 26 Aug 2009. doi:10.1038/4601057a .
For his part, Mitalipov stresses the potential benefits of this research and notes “The only way to treat these defects is to replace the genes” (Mark Henderson, DNA swap could cure inherited diseases. Times Online. August 27, 2009. According to Nature News, others in the mitochondrial-disease community agree; Carlos Moraes, for example, comments: “There are costs and risks, but the benefits outweigh the drawbacks.”
- Richard Harris. A Potential But Controversial Fix For Genetic Disease. NPR: All Things Considered. August 27, 2009.
- Richard Alleyne. Hereditary diseases could be eradicated before birth by ‘genetically modifying’ eggs. Telegraph.co.uk. August 26, 2009.
- Pallab Ghosh. Genetic advance raises IVF hopes. BBC News. August 26, 2009.
- Rob Waters. Gene Mix in Monkeys Fixes Defects, Opens New Ethics Debate. Bloomberg.com. August 26, 2009.
Reference:
Tachibana M, Sparman M, Sritanaudomchai H, et al. Mitochondrial gene replacement in primate offspring and embryonic stem cells. Nature 26 Aug 2009. doi:10.1038/nature08368
Related:
Ghostwriting and the Pharmaceutical Industry
Documents unearthed in lawsuits against Wyeth regarding the cancer risks of its hormone drugs Premarin and Prempro expose how ghost-writers (hired guns from the company DesignWrite) wrote the bulk of several articles published in 18 peer-reviewed, medical journals. The New York Times reports the papers were published under the names of “top physicians” solicited as “authors”. The role of Wyeth and the ghostwriters was not disclosed in the publication of these (mostly) review articles. One of the physician “authors”, Gloria Bachmann, defends the legitimacy of her authorship, stating: “This is my work, this is what I believe, this is reflective of my view.”
On this point, Chris MacDonald at The Research Ethics Blog, observes: “The problem is not whether the paper that resulted from the ghost-writing process was sound, or whether it represented a point of view that Dr. Bachmann could stand behind. The point is: how can we be sure? How do we know just how much, or how little, influence Wyeth, had on the paper that resulted?”
- Natasha Singer. Medical papers by ghostwriters pushed therapy. The New York Times. Aug 4, 2009.
- Chris MacDonald. Ghost-writing and the corruption of research. The Research Ethics Blog. Aug 5, 2009.
- Natasha Singer. Senator Moves to Block Medical Ghostwriting. The New York Times. August 18, 2009.
- Ginny Barbour. Ghostwriting documents now fully available on PLoS Medicine website. Speaking of Medicine. August 21, 2009.
- A Case Study in Medical Writing. The New York Times.
- Publication Ethics Policies for Medical Journals. World Association of Medical Editors (WAME).
- Charles E. Grassley, Ranking Member, Committee on Finance, United States Senate. Letter to Mitchell A. Leon, President, DesignWrite Inc. December 12, 2008. http://finance.senate.gov/press/Gpress/2008/prg121208a.pdf
- Duff Wilson. Drug Maker Said to Pay Ghostwriters for Journal Articles. The New York Times. December 12, 2008.
- Gøtzsche PC, Kassirer JP, Woolley KL, et al. What should be done to tackle ghostwriting in the medical literature? PLoS Med. 2009 Feb 3;6(2):e23. PMID: 19192943
- Ross JS, Hill KP, Egilman DS, Krumholz HM. Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA. 2008 Apr 16;299(15):1800-12. PMID: 18413874.
- Sismondo S. Ghost management: how much of the medical literature is shaped behind the scenes by the pharmaceutical industry? PLoS Med. 2007 Sep;4(9):e286. PMID: 17896859
- Moffatt B, Elliott C. Ghost marketing: pharmaceutical companies and ghostwritten journal articles. Perspect Biol Med. 2007 Winter;50(1):18-31. PMID: 17259673.
References:
Related Articles and Links:
More Research Ethics News
Sarah Arnquist. Research Trove: Patients’ Online Data. The New York Times. August 24, 2009.
Christine Kim and Jon Herskovitz. S. Korea seeks 4-year prison term for stem cell fraud. Reuters. August 24, 2009.
Salley Satel. Clinical Trials, Wrapped in Red Tape. The New York Times. August 7, 2009.
Related: Joan Rachlin. Who is Sally Satel and why is she saying those things about IRBs? Ampersand. August 25, 2009.
The Role for Science in Regulatory Policy. Jeffrey Mervis, ScienceInsider. August 5, 2009.
FDA, Europeans collaborate on drug trial practices. Jennifer Lubell, ModernHealthcare.com. August 3, 2009.
Lack of Study Volunteers Hobbles Cancer Fight. Gina Kolata, The New York Times. August 2, 2009.
Related: Forty Years’ War Series. The New York Times.
Pregnant Women Will Be Included in H1N1 Flu Vaccine Trials. Deborah Kotz, On Women: U.S. News & World Report. July 30, 2009.
NY Taxpayers to Pay Donors for Stem Cell Studies. AP, The New York Times. July 30, 2009.
Darnovsky M, Reynolds J. The battle to patent your genes: the meaning of the Myriad case. The American Interest [Online]. September-October, 2009.
What to do with big bad industry? Ben Eisen, Inside Higher Ed. July 30, 2009.
Related: Senate considers industry influence in Continuing Medical Education. Katherine Mangan, The Chronicle of Higher Education. July 29, 2009. [Subscription Required]
PredictER: Predictive Health Ethics Research
Children, Biobanks and Consent
In a recent policy forum published in the Science, ethicists argue in favor of a policy to recontact children once they reach "the age of consent" to seek permission for continued research on their DNA samples and data. ... Read more from PredictER Blog, August 18, 2009.
New German Law on Genetic Testing: More Than Just a German GINA
EuroGentest has recently posted an unofficial English translation of the recently passed and soon to be enacted German legislation, the Human genetic examination act (Genetic diaganosis act - GenDG) [PDF - 162 KB]. ... Read more from PredictER Blog, August 5, 2009.
Research Ethics in the Academic Literature
Disclosing Adverse Clinical Trials Results
In a recent “target article” for an AJOB "Open Peer Commentary", S. Matthew Liao, Mark Sheehan and Steve Clarke make a case for a moral duty to disclose all adverse clinical trial results to potential participants. They argue, in short, that consent is not “informed” when participants lack risk information. Pharmaceutical companies, however, have an interest in protecting information about the development of new products. Although the authors believe the safety of human subjects should be protected even when intellectual property may be disclosed, their analysis concludes that current regulatory practices “fail to promote the duty to disclose adverse clinical trial results and … fail to ensure that sensitive information are not passed on to commercial competitors”. They point to both the US FDA Modernization Act (FDAMA) of 1997 and the US FDA Amendments Act of (FDAAA) 2007 as inadequate. The Modernization Act makes “no requirement to disclose any adverse trials results to trial participants.” Likewise, the Amendments Act of 2007 does not require the disclosure of safety tests conducted in phase I and phase II trials. At the same time, the authors assert, these regulations make no effort to protect commercial interests. To remedy these inadequacies, the authors propose a database of adverse clinical trial results administered by an oversight body. Additionally, the authors argue for legally binding agreements to protect human subjects and pharmaceutical companies:
Pharmaceutical companies would face appropriate penalties for failure to make disclosure of adverse clinical trial results. Prospective participants would be required to sign a confidentiality agreement regarding the information that has been disclosed to them by the oversight body and would face appropriate penalties for any breaches of this agreement.
- Hassoun N. The Duty to Disclose (Even More) Adverse Clinical Trial Results. AJOB 2009;9(8):33.
- McGoey L. Compounding Risks to Patients: Selective Disclosure is Not an Option. AJOB 2009;9(8):35.
- Shah KR, Batzer FR. Improving Subject Recruitment by Maintaining Truly Informed Consent: A Practical Benefit of Disclosing Adverse Clinical Trial Results. AJOB 2009;9(8):36.
- Oakley J. Respecting Participant Autonomy and the Disclosure of Clinical Trial Results. AJOB 2009;9(8):38.
- Banja JD, Dunlop B. Enhancing Informed Consent in Clinical Trials and Exploring Resistances to Disclosing Adverse Clinical Trial Results. AJOB 2009;9(8):39.
- Saunders PT. The Duty to Register Phase I Trials. AJOB 2009;9(8):41.
- Wu KC. Precautionary Harm Disclosure in Clinical Trials. AJOB 2009;9(8):43.
- Vernillo A. Disclosure of Adverse Clinical Trial Results—Should Legal Immunity Be Granted to Drug Companies? AJOB 2009;9(8):45.
- ClinicalStudyResults.org
- ClinicalTrials.gov
- [ClinicalTrials.gov Protocol Registration System] PRS and U.S. Public Law 110-85
- ClinicalStudyResults.org
- Food and Drug Administration Amendments Act (FDAAA) of 2007
- Food and Drug Administration Modernization Act (FDAMA) of 1997
- WHO International Clinical Trials Registry Platform
Reference:
Liao SM, Sheehan M, Clarke S. The duty to disclose adverse clinical trial results. AJOB 2009;9(8). DOI: 10.1080/15265160902984988
Peer Commentaries:
Related Links:
Research Ethics Bibliography, August 2009
Sismondo S. Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials - By Jill A. Fisher When Experiments Travel: Clinical Trials and the Global Search for Human Subjects - By Adriana Petryna. Bioethics 2009 Aug 25. PMID: 19709080
Meyers K. Financial conflicts and clinical research. IRB 2009 Jul-Aug;31(4):17. PMID: 19697540
Marshall J, Hadskis MR. Canadian research ethics boards, MRI research risks, and MRI risk classification. IRB 2009 Jul-Aug;31(4):9-15. PMID: 19697539
Koyfman SA, McCabe MS, Emanuel EJ, Grady C. A consent form template for phase I oncology trials. IRB 2009 Jul-Aug;31(4):1-8. PMID: 19697538
Silverman H, Ahmed B, Ajeilet S, Al-Fadil S, Al-Amad S, El-Dessouky H, El-Gendy I, El-Guindi M, El-Nimeiri M, Muzaffar R, Saleh A. Curriculum guide for research ethics workshops for countries in the Middle East. Dev World Bioeth 2009 Aug 18. PMID: 19694781
Eberl JT, Ballard RA. Metaphysical and Ethical Perspectives on Creating Animal-Human Chimeras. J Med Philos 2009 Aug 19. PMID: 19692673
Napier S. A Regulatory Argument Against Human Embryonic Stem Cell Research. J Med Philos 2009 Aug 18. PMID: 19690326
Shemdoe GS. Introduction to intellectual property rights for investigators in health research and institutional intellectual property policy. Acta Trop 2009 Aug 13. PMID: 19682967
Drabiak-Syed K. State codification of federal regulatory ambiguities in biobanking and genetic research. J Leg Med 2009 Jul-Sep;30(3):299-327. PMID: 19681010
Gurwitz D, Fortier I, Lunshof JE, Knoppers BM. Research ethics. Children and population biobanks. Science 2009 Aug 14;325(5942):818-9. PMID: 19679798
Serrano-Delgado M, Novello-Garza BI, Valdez-Martinez E. Ethical issues relating to the banking of umbilical cord blood in Mexico. BMC Med Ethics 2009 Aug 14;10(1):12. PMID: 19678958
Kilama WL. Health research ethics in public health: Trials and implementation of malaria mosquito control strategies. Acta Trop 2009 Aug 8. PMID: 19665982
Nyika A. Professional ethics: An overview from health research ethics point of view. Acta Trop 2009 Aug 7. PMID: 19665439
Singh JA. Research and legal liability. Acta Trop 2009 Aug 7. PMID: 19665438
Chong SA, Huxtable R, Campbell A. Authorizing psychiatric research: principles, practices and problems. Bioethics 2009 Jul 14. PMID: 19659857
Sachs B. Going from principles to rules in research ethics. Bioethics 2009 Jul 29. PMID: 19659855
Allen J, McNamara B. Reconsidering the value of cosent in biobank research. Bioethics 2009 Jul 29. PMID: 19659851
Bruce JC, Langley GC, Tjale AA. The use of experts and their judgments in nursing research: an overview. Curationis 2008 Dec;31(4):57-61. PMID: 19653538
McGowan ML, Burant CJ, Moran R, Farrell R. Patient education and informed consent for preimplantation genetic diagnosis: health literacy for genetics and assisted reproductive technology. Genet Med 2009 Jul 31. PMID: 19652605
Nyika A. Animal research ethics in Africa: An overview. Acta Trop 2009 Jul 30. PMID: 19646942
Taiwo OO, Kass N. Post-consent assessment of dental subjects' understanding of informed consent in oral health research in Nigeria. BMC Med Ethics 2009;10:11. PMID: 19646279
Taljaard M, Weijer C, Grimshaw JM, Belle Brown J, Binik A, Boruch R, Brehaut JC, Chaudhry SH, Eccles MP, McRae A, Saginur R, Zwarenstein M, Donner A. Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study. Trials 2009;10:61. PMID: 19638233
Willison DJ, Steeves V, Charles C, Schwartz L, Ranford J, Agarwal G, Cheng J, Thabane L. Consent for use of personal information for health research: do people with potentially stigmatizing health conditions and the general public differ in their opinions? BMC Med Ethics 2009;10:10. PMID: 19630941
Jesus JE, Michael GE. Ethical considerations of research in disaster-stricken populations. Prehosp Disaster Med 2009 Mar-Apr;24(2):109-14. PMID: 19591303
Zwart H, Nelis A. What is ELSA genomics? Science & society series on convergence research. EMBO Rep 2009 Jun;10(6):540-4. PMID: 19488040
Smith-Doerr L. Discourses of dislike: responses to ethics education policies by life scientists in the U.K., Italy, and the U.S. J Empir Res Hum Res Ethics 2009 Jun;4(2):49-57. PMID: 19480591
Mallick AA, O'Callaghan FJ. Research governance delays for a multicentre non-interventional study. J R Soc Med 2009 May;102(5):195-8. PMID: 19417052
Holtzman NA. The evidence dilemma and cultural change. Health Aff (Millwood) 2009 May-Jun;28(3):925-6; author reply 6-7. PMID: 19414911
Draper H, Wilson S, Flanagan S, Ives J. Offering payments, reimbursement and incentives to patients and family doctors to encourage participation in research. Fam Pract 2009 Jun;26(3):231-8. PMID: 19261621
Kuhar MJ. Blacklisting among scientists. Synapse 2009 Jul;63(7):539-40. PMID: 19253401
Carter B. Tick box for child? The ethical positioning of children as vulnerable, researchers as Barbarians and reviewers as overly cautious. Int J Nurs Stud 2009 Jun;46(6):858-64. PMID: 19215922
Schuurbiers D, Osseweijer P, Kinderlerer J. Implementing the Netherlands code of conduct for scientific practice-a case study. Sci Eng Ethics 2009 Jun;15(2):213-31. PMID: 19156537
Parrish D, Noonan B. Image manipulation as research misconduct. Sci Eng Ethics 2009 Jun;15(2):161-7. PMID: 19125357
Schrag B. Piercing the veil: ethical issues in ethnographic research. Sci Eng Ethics 2009 Jun;15(2):135-60. PMID: 19034693
Garrafa V, Lorenzo C. Moral imperialism and multi-centric clinical trials in peripheral countries. Cad Saude Publica 2008 Oct;24(10):2219-26. PMID: 18949224
Dunn LB, Kim DS, Fellows IE, Palmer BW. Worth the risk? Relationship of incentives to risk and benefit perceptions and willingness to participate in schizophrenia research. Schizophr Bull 2009 Jul;35(4):730-7. PMID: 18281293
This news digest is supported by NIH/NCRR Grant Number RR025761. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.
To follow the news in "real time", to leave comments on stories, or to subscribe to RSS feeds, visit Indiana Bioethics. Many of the items in this news digest were previously published on the Indiana Bioethics blog, category REND.
Readers interested in the ethics of genetic research, genetic testing, and personalized medicine will want to visit PredictER Blog, a publication of the Indiana University Center for Bioethics Predictive Health Ethics Research (PredictER) program.
Editor: Jere Odell
