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Bioethics and Research Protections News July to December 2011

Inside the Pentagon's Alt-Medicine Mecca, Where the Generals Meditate. Katie Drummond Wired 2011-12-23: http://www.wired.com/dangerroom/2011/12/pentagon-alt-med-mecca/all/1

Troubled study at heart of therapy debate. Trine Tsouderos Chicago Tribune 2011-12-12: http://www.chicagotribune.com/health/ct-met-nccam-tact-trial-20111212,0,1974124.story

Study's doctors have had their share of troubles. Trine Tsouderos Chicago Tribune 2011-12-12: http://www.chicagotribune.com/health/ct-met-tact-sidebar-20111212,0,1311776.story

Federal center pays good money for suspect medicine. Trine Tsouderos Chicago Tribune 2011-12-11: http://www.chicagotribune.com/health/ct-met-nccam-overview-20111211,0,3391775.story

Geron's Discontinued Stem Cell Trial: What About the Research Participants? Françoise Baylis Bioethics Forum 2011-12-02: http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=5640&blogid=140

Former Executives of International Medical Device Maker Sentenced to Prison in Unlawful Clinical Trials Case. US Department of Justice Press Release 2011-11-21: http://www.justice.gov/usao/pae/News/2011/Nov/synthesexecs_release.pdf

Follow this link for case documents posted on the CIRCARE web site: http://www.circare.org/lex/synthes/synthes.htm

Drugmakers Mine Data for Trial Patients. Carol Eisenberg. Bloomberg BusinessWeek 2011-11-03: http://www.businessweek.com/magazine/drugmakers-mine-data-for-trial-patients-11032011.html

PACeR Patnership to Advance Clinical Electronic Research: http://pacerhealth.org/index.cfm

OU Professor Accused Of Questionable Medical Practices On Students. Adrianna Iwasinski. News9.com Oklahoma 2011-11-01: http://www.news9.com/story/15920118/ou-professor-accused-of-using-students-as-guinea-pigs-for-experiments

Should the New Anthrax Vaccine Be Tested on Children? Art Caplan Science Progress 2011-11-01: http://scienceprogress.org/2011/11/should-the-new-anthrax-vaccine-be-tested-on-children/

Challenges in the Use of Anthrax Vaccine Adsorbed (AVA) in the Pediatric Population as a Component of Post-Exposure Prophylaxis (PEP). National Biodefense Science Board October 2011: http://www.phe.gov/Preparedness/legal/boards/nbsb/meetings/Documents/avwgrpt-111025.pdf

National Biodefense Science Board: http://www.phe.gov/Preparedness/legal/boards/nbsb/meetings/Pages/default.aspx

Stem Cell Tourism: Seeking Treatment On The Internet And Paying For It With Your Life. Peter Murry Singularity Hub 2011-10-06: http://singularityhub.com/2011/10/06/stem-cell-tourism-seeking-treatment-on-the-internet-and-paying-for-it-with-your-life/

Manipulation alleged in paper linking virus, chronic fatigue syndrome. Trine Tsouderos Chicago Tribune 2011-10-04: http://www.chicagotribune.com/health/chi-chronic-fatigue-syndrome-paper-10032011,0,6792877.story

The Rise of Unregulated Drug Trials in South America. Kelly Hearn The Nation 2011-09-21: http://www.thenation.com/article/163547/rise-unregulated-drug-trials-south-america

China stem cell therapies offer heartbreak for many. Tan Ee Lyn Reuters 2011-09-21: http://www.reuters.com/article/2011/09/21/us-stemcell-scams-idUSTRE78K18120110921

Second lawsuit filed against Duke for Potti's research. Beth Velliquette The Herald Sun 2011-09-19: http://www.heraldsun.com/view/full_story/15553581/article-Second-lawsuit-filed-against-Duke-for-Potti%E2%80%99s-research?instance=homethirdleft

Ethically Impossible: STD Research in Guatemala from 1946-1953. Presidential Commission for the Study of Bioethical Issues 2011-09: http://bioethics.gov/cms/sites/default/files/Ethically-Impossible_PCSBI.pdf

Interim analysis of Merck's Vytorin trial delayed. Reuters 2011-09-13: http://www.reuters.com/article/2011/09/13/merck-idUSS1E78C0D320110913

Misconduct in science: An array of errors. The Economist 2011-09-10: http://www.economist.com/node/21528593

Duke Sued Over Clinical Trials. Shae Crisson ABC News WTVD-TV Raleigh-Durham 2011-09-08: http://abclocal.go.com/wtvd/story?section=news/abc11_investigates&id=8346506

Richard Aiken et al. Civil No. 11CVS4721 General Court of Justice Superior Court Division Durham County, NC Complaint 2011-09-07: http://www.circare.org/lex/11cvs4721_complaint.pdf [courtesy of ABC News, WTVD, Durham]

Scroll through the remarkable documents on the Anil Potti/Duke U. case assembled by Paul Goldberg, editor of The Cancer Letter: http://www.cancerletter.com/categories/documents

Institute of Medicine, Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials: http://www.iom.edu/Activities/Research/OmicsBasedTests.aspx

Should the US Compensate Injured Trial Patients? Ed Silverman Pharmalot Blog 2011-09-01: http://www.pharmalot.com/2011/09/should-the-us-compensate-injured-trial-patients/

Bioethics commission condemns Guatamalan syphilis research as unethical. Nature News Blog 2011-08-30: http://blogs.nature.com/news/2011/08/commission_condemns_guatamalan_1.html

Syphilis Experiments Shock, But So Do Third World Drug Trials. Susan Donaldson James ABC News 2011-08-30: http://abcnews.go.com/Health/guatemala-syphilis-experiments-shock-us-drug-trials-exploit/story?id=14414902

Research Across Borders: Proceedings of the International Research Panel of the Presidential Commission for the Study of Bioethical Issues (draft?) 2011-08-30: http://bioethics.gov/cms/sites/default/files/IRP-Proceedings%20and%20Recommendations_0.pdf

Growth of egg freezing blurs 'experimental' label. Alison Motluk Nature 476, 383-383 (2011) 2011-08-23: http://www.nature.com/news/2011/110823/full/476382a.html

At least 22 people died during clinical trials of drugs. The Hindu 2011-08-11: http://m.thehindu.com/news/national/article2316837.ece/

Bhopal: Drug Trials Conducted on Gas Victims. Hemender Sharma. India News IBNLive 2011-08-07: http://ibnlive.in.com/news/bhopal-drug-trials-conducted-on-gas-victims/173624-3.html

ANPRM for Revision to Common Rule Information Related to Advanced Notice of Proposed Rulemaking (ANPRM) for Revisions to the Common Rule 2011-07-22 [Deadline for submission of comments is 2011-09-26]: http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html

Read the proposed changes to the Common Rule online [HTML]: http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18792.htm [PDF]: http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/pdf/2011-18792.pdf (ca. 88 pp. in MS Word)

How to submit comments on the proposed changes to the Common Rule: http://www.hhs.gov/ohrp/humansubjects/submitanprmcomment.html

Outsourced: Clinical Trials Overseas. Al Jazeera 2011-07-11: http://english.aljazeera.net/programmes/faultlines/2011/07/2011711112453541600.html


Last Updated: 2012-02-19

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