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News Outlets | News Stories Archived by Month and Year (2002-) | News Stories From 2001 and Earlier

Research Protection and Bioethics in the News

New Index of Information on Trachea Transplants and Paolo Macchiarini

Why drug trials need to respect vulnerability Sanjit Das SciDevNet 2016-08-02 http://www.scidev.net/global/ethics/opinion/drug-trials-vulnerability-ethics-human-rights-india.html

Europe overhauls rules for first-in-human trials in wake of French disaster Hinnerk Feldwisch-Drentrup Science 2016-07-25 http://www.sciencemag.org/news/2016/07/europe-overhauls-rules-first-human-trials-wake-french-disaster

Redman BK, Caplan AL Limited Reproducibility of Research Findings: Implications for the Welfare of Research Participants and Considerations for Institutional Review Boards IRB: Ethics & Human Research 38;4 July-August 2016 http://www.thehastingscenter.org/irb_article/limited-reproducibility-research-findings-implications-welfare-research-participants-considerations-institutional-review-boards/

Companies Try New Ways to Attract Patients to Drug Trials Jonathan D. Rockoff Wall Street Journal 2016-07-18 http://www.wsj.com/articles/companies-try-new-ways-to-attract-patients-to-drug-trials-1468858289

Hospitals in Philadelphia test a counterintuitive approach to save gunshot victims Errin Haines Whack AP via STAT News 2016-07-15 https://www.statnews.com/2016/07/15/philadelphia-gunshot-victims/

Doctor who blew whistle on defunded study speaks Alison McCook Retraction Watch 2016-07-15 http://retractionwatch.com/2016/07/15/patient-asked-to-pay-15k-another-broke-her-leg-whistleblower-on-revoked-funding-for-paralysis-study-speaks/

U of L, KyCIR spar over spinal cord research story The Courier-Journal 2016-07-13 http://www.courier-journal.com/story/news/local/science/2016/07/13/u-l-defends-work-spinal-cord-researchers/87038990/

Top U of L Researcher Loses Federal Funding For Paralysis Study Kate Howard KY Center for Investigative Reporting 2016-07-11 http://kycir.org/2016/07/11/top-u-of-l-researcher-loses-federal-funding-for-paralysis-study/

Pontus Boström: cheater carousel in Sweden Leonid Schneider For Better Science Blog 2016-07-07 https://forbetterscience.wordpress.com/2016/07/07/pontus-bostrom-cheater-carousel-in-sweden/

Research fraud: the temptation to lie — and the challenges of regulation Ian Freckelton QC The Conversation https://theconversation.com/research-fraud-the-temptation-to-lie-and-the-challenges-of-regulation-58161

In clinical trials, for-profit review boards are taking over for hospitals. Should they? Sheila Kaplan STAT News 2016-07-06 https://www.statnews.com/2016/07/06/institutional-review-boards-commercial-irbs/

Turner L., Knoepfler P. Selling Stem Cells in the USA: Assessing the Direct-to-Consumer Industry Cell Stem Cell (in press corrected proof) http://www.cell.com/cell-stem-cell/fulltext/S1934-5909(16)30157-6

Congress Should Create Commission to Examine the Protection of Human Participants in Research; Notice of Proposed Rulemaking to Revise Common Rule Should Be Withdrawn News Release The National Academy 2016-06-29 http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=21824

Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century National Academies Press 2016 http://www.nap.edu/catalog/21824/optimizing-the-nations-investment-in-academic-research-a-new-regulatory

J&J Unit Performed Human Experimentation With Deadly Bone Cement, Jury Told David Siegal CVN Blog 2016-06-28 http://blog.cvn.com/jj-unit-performed-human-experimentation-with-deadly-bone-cement-jury-told

An N.Y.U. Study Gone Wrong, and a Top Researcher Dismissed Benedict Carey New York Times 2016-06-27 http://www.nytimes.com/2016/06/28/health/nyu-cannabis-ptsd-psychiatry.html

FDA Warning Letter to Alexander Neumeister, M.D. 2016-02-19 http://www.circare.org/fdawls3/neumeister-fdawl-20160219.pdf

Fear and Loathing in Bioethics (A Manifesto) Carl Elliot Fear and Loathing in Bioethics Blog 2016-06-27 http://loathingbioethics.blogspot.com/2016/06/fear-and-loathing-in-bioethics-manifesto.html

Are Things Getting Any Better in the Clinic? Derek Lowe In the Pipeline Blog 2016-06-02: http://blogs.sciencemag.org/pipeline/archives/2016/06/02/are-things-getting-any-better-in-the-clinic

U of M psychiatrists reprimanded after dead patient's private records posted online Susan Du City Pages 2016-05-26 http://www.citypages.com/news/u-of-m-psychiatrists-reprimanded-after-dead-patients-private-records-posted-online-8304454

Sellmann Charles Schulz, M.D. Minnesota Board of Medical Practice Reprimand 2016-05-16 http://www.circare.org/pd/schulz-reprimand-20160514.pdf

Stephen Craig Olson, M.D. Minnesota Board of Medical Practice Reprimand 2016-05-16 http://www.circare.org/pd/olson-reprimand-20160514.pdf

France says drug maker and testing firm partly to blame for patient death Ed Silverman STAT News 2016-05-23 https://www.statnews.com/pharmalot/2016/05/23/france-blames-drug-maker-testing-firm-patient-deaths/

Bone cement company accused of experimenting on humans CBS News/AP 2016-05-21 http://www.cbsnews.com/news/bone-cement-company-norian-accused-of-experimenting-on-humans/

New Study Demonstrates NIH-Funded Clinical Trial on Premature Babies Inconsistent With Usual Care, Consent Forms Inaccurate Public Citizen Health Research Group Press Release 2016-05-19 http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=7896

CortÚs-Puch I, Wesley RA, Carome MA, Danner RL, Wolfe SM, Natanson C. Usual Care and Informed Consent in Clinical Trials of Oxygen Management in Extremely Premature Infants PLoS One. 2016 May 18;11(5):e0155005. http://dx.doi.org/10.1371/journal.pone.0155005

Legislative auditor: Bureaucracy slows U conflict of interest reforms Jeremy Olson Star Tribune 2016-05-19 http://www.startribune.com/auditor-bureaucracy-slowing-u-conflict-of-interest-reforms/380143541/

Protections for Human Subjects in Research Studies at the University of Minnesota Department of Psychiatry: A Preliminary Assessment of Reforms Minnesota Office of the Legislative Auditor 2016-05-19 http://www.auditor.leg.state.mn.us/sreview/humanresearch.pdf

A Big-time Neuroscientist Threatened to Sue When I Asked About His Side Business Selling Supplement Tonics Jesse Singal NY Magazine 2016-05-11 http://nymag.com/scienceofus/2016/05/a-big-time-neuroscientist-threatened-to-sue-when-i-asked-about-his-side-business.html

Exclusive: Patient safety issues prompt leadership shake-up at NIH hospital Lena H. Sun Washington Post 2016-05-10 https://www.washingtonpost.com/national/health-science/exclusive-patient-safety-issues-prompt-leadership-shake-up-at-nih-hospital/2016/05/10/ad1f71f6-0ffb-11e6-8967-7ac733c56f12_story.html?wpisrc=al_alert-national

Professional 'Guinea Pigs' Can Make A Living Testing Drugs Rae Ellen Bichell National Public Radio Shots 2016-05-08 http://www.npr.org/sections/health-shots/2016/05/08/476797735/professional-guinea-pigs-can-make-a-living-testing-drugs

Just Another Lab Rat Forums

Botched French Drug Trial Followed Rules But Lacked 'Common Sense' Rae Ellen Bichell National Public Radio Shots 2016=-05-03 http://www.npr.org/sections/health-shots/2016/05/03/475867184/botched-french-drug-trial-followed-rules-but-lacked-common-sense

Survivor of lethal French drug trial speaks out Lara Marlowe Irish Times 2016-05-01 http://www.irishtimes.com/news/world/europe/survivor-of-lethal-french-drug-trial-speaks-out-1.2554593

Confronting the Legacy That Keeps African Americans Away From Clinical Trials Alexis Sobel Fitts Undark 2016-04-28 http://undark.org/2016/04/28/confronting-legacy-keeps-african-americans-away-clinical-trials/

Experience: I ran a medical trial that went wrong Daniel Bradford The Guardian 2016-04-22 http://www.theguardian.com/lifeandstyle/2016/apr/22/experience-i-ran-medical-trial-that-went-wrong

Eastwood, D., Findlay, L., Poole, S., Bird, C., Wadhwa, M., Moore, M., Stebbings, R. (2010). Monoclonal antibody TGN1412 trial failure explained by species differences in CD28 expression on CD4+ effector memory T–cells. British Journal of Pharmacology, 161(3), 512–526. http://doi.org/10.1111/j.1476-5381.2010.00922.x

Task Force Calls For More Safety Oversight At NIH Research Hospital Nell Greenfieldboyce National Public Radio 2016-04-21 http://www.npr.org/sections/health-shots/2016/04/21/475045732/task-force-calls-for-more-safety-oversight-at-nih-research-hospital

Researchers Failed to Obtain Informed Consent From Patients Involved in Kidney Transplant Experiment Public Citizen Health Research Group Press Release 2016-04-20 http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=5872

Public Citizen Allegations of Non-compliance to OHRP and VA ORO http://www.citizen.org/documents/2315.pdf

Niemann CU, Feiner J, Swain S, et al. Therapeutic hypothermia in deceased organ donors and kidney-graft function. N Engl J Med. 2015;373:405-414 http://www.nejm.org/doi/full/10.1056/NEJMoa1501969

First spotted on PubPeer https://pubpeer.com/publications/21AB5D15CF2895BF5E6F0E8963B420

FDA warns another Indian drug maker on serious quality control lapses Ed Silverman STAT News 2016-04-20 https://www.statnews.com/pharmalot/2016/04/20/fda-drug-safety-generics/

Contamination problems prompt NIH to suspend operations at two facilities Dylan Scott STAT News 2016-04-19 https://www.statnews.com/2016/04/19/nih-suspends-operations-facilities/

Chocolate milk maker wanted study touted with 'Concussion' Candace Choi AP 2016-04-19 https://www.statnews.com/2016/04/19/concussion-chocolate-milk-study/

When universities stonewall investigations of research misconduct Ivan Oransky and Adam Marcus STAT News 2016-04-05 https://www.statnews.com/2016/04/05/universities-research-misconduct/

University of Maryland committee finds fault in school's research, promotion of chocolate milk study Sarah Gantz Baltimore Business Journal 2016-04-01 http://www.bizjournals.com/baltimore/news/2016/04/01/university-of-maryland-committee-finds-fault-in.html

University of Maryland crosses ethical boundaries with chocolate milk study, experts say Sarah Gantz Baltimore Business Journal 2016-01-12 http://www.bizjournals.com/baltimore/news/2016/01/12/university-of-maryland-pushes-ethical-boundaries.html

U of Maryland review: researcher on flawed chocolate milk/concussions study failed to disclose big dairy donations Health News Review 2016-04-01 [ed. no it's not a joke] http://www.healthnewsreview.org/2016/04/u-of-maryland-review-researcher-on-flawed-chocolate-milkconcussions-study-failed-to-disclose-big-dairy-donations/

Macchiarini dismissed from Karolinska Alison McCook Retraction Watch 2016-03-23 http://retractionwatch.com/2016/03/23/macchiarini-dismissed-from-karolinska/

FDA bans trial coordinator who pocketed patient funds and went to prison Alison McCook Retraction Watch 2016-03-21 http://retractionwatch.com/2016/03/21/fda-bans-trial-coordinator-who-pocketed-patient-funds-and-went-to-prison/

Additional information on this case

High Doses Of Experimental Drug Implicated In Botched French Study Rae Ellen Bichell NPR 2016-03-09: http://www.npr.org/sections/health-shots/2016/03/09/469786037/high-doses-of-experimental-drug-implicated-in-botched-french-study

Cancer 'Visionary' Stanislaw Burzynski Stands Trial for Unprecedented Medical Malfeasance Tamar Wilner Newsweek 2016-02-22: http://www.newsweek.com/2016/03/04/stanislaw-burzynski-cancer-medical-malfeasance-429057.html

$30M malpractice settlement against doctor who worked at Chicago hospitals Ameet Sachdev Chicago Tribune 2016-02-22: [Dr Mark Holterman worked with Paolo Macchiarini to perform synthetic trachea transplant on Hannah Warren at Illinois Children's Hospital] http://www.chicagotribune.com/business/ct-rush-medical-malpractice-settlement-0223-biz-20160222-story.html

Macchiarini and Karolinska: the biomedical ethics meltdown. Leonid Schneider For Better Science Blog 2016-02-21: https://forbetterscience.wordpress.com/2016/02/21/macchiarini-and-karolinska-the-biomedical-ethics-meltdown/

Reading about embattled trachea surgeon Paolo Macchiarini? Here's what you need to know. Retraction Watch 2016-02-12: http://retractionwatch.com/2016/02/12/reading-about-embattled-trachea-surgeon-paolo-macchiarini-heres-what-you-need-to-know/

New: Index of Information about Dr. Paolo Macchiarini and Trachea Transplants

KI physicians' request for investigation 2014-08-18: http://retractionwatch.com/wp-content/uploads/2014/12/Letter-to-Prof-Hamsten.pdf

Analysis of 6 papers of Paolo Macchiarini: http://retractionwatch.com/wp-content/uploads/2014/12/Analysis-of-Clinical-Outcome-of-Synthetic-Tracheal-Transplantation.pdf

Appendices 1-10: http://retractionwatch.com/wp-content/uploads/2014/12/Appendix-1-10.pdf

Appendices 11-20: http://retractionwatch.com/wp-content/uploads/2014/12/Appendix-11-20-review-article.pdf

Appendices 21-30: http://retractionwatch.com/wp-content/uploads/2014/12/Appendix-21-30.pdf

Appendices 31-40: http://retractionwatch.com/wp-content/uploads/2014/12/Appendix-31-40.pdf

Appendices 41-50: http://retractionwatch.com/wp-content/uploads/2014/12/Appendix-41-54.pdf

Ki physicians' amendment to request for investigation 2014-09-24: http://retractionwatch.com/wp-content/uploads/2014/12/AMENDMENT-to-Formal-Appeal-24sep2014-2.pdf

Table of information: http://retractionwatch.com/wp-content/uploads/2014/12/AMENDMENT-Tables-1-3-24sep2014.pdf

Amendment Appendices 1-10: http://retractionwatch.com/wp-content/uploads/2014/12/Apendix-Amendment-1-10.pdf

Amendment Appendices 11-19: http://retractionwatch.com/wp-content/uploads/2014/12/Appendix-Amendment-11-19.pdf

English translation of KI external investigator Bengt Gerdin re: allegations of misconduct by Paolo Macchiarini 2015-05-13: http://retractionwatch.com/wp-content/uploads/2015/05/Translation-investigation.doc

Paolo Macchiarini reply to Ki physicians' allegations of misconduct 2015-04-06: http://www.svt.se/svts/article2971402.svt/binary/PM%20yttrande%20i%20april..pdf

Paolo Macchiarini reply to allegations of scientific misconduct 2015-06-26: http://www.circare.org/info/pm/si-Paolo Macchiarini response.pdf

Corriere Fiorentino search for Macchiarini: http://tinyurl.com/hj57y9r

Lab criticized as slow to act in fatal French drug trial Matthias Blamont Rueters 2016-02-02: http://www.reuters.com/article/us-france-health-test-idUSKCN0VD1Z3

Karolinska Institute has 'lost confidence in Paolo Macchiarini, says it won't renew his contract Gretchen Vogel Science News 2016-02-04: http://www.sciencemag.org/news/2016/02/karolinska-institute-has-lost-confidence-paolo-macchiarini-says-it-wont-renew-his

Clinical Trial Disaster in France Jonathan Kimmelman Impact Ethics 2016-02-02: https://impactethics.ca/2016/02/02/clinical-trial-disaster-in-france/

Citizens United Asks Why Wasn't Former Synthes CEO Jailed QMed Staff 2016-01-29 http://www.qmed.com/news/citizens-united-asks-why-wasn%E2%80%99t-former-synthes-ceo-jailed

A Clinical Disaster in France Derek Lowe In the Pipeline Blog 2016-01-15: http://blogs.sciencemag.org/pipeline/archives/2016/01/15/a-clinical-disaster-in-france

BIAL Protocol BIA-102474-101 : ansm.sante.fr/content/download/84709/1069533/version/2/file/PI_essai_clinique_bial_220116english_3.pdf

What we know so far about the clinical trial disaster in France Martin Enserink Science 2016-01-15: http://www.sciencemag.org/news/2016/01/what-we-know-so-far-about-clinical-trial-disaster-france

6 Hospitalized, One of Them Brain-Dead, After Drug Trial in France Sewell Chan NY Times 2016-01-15: http://www.nytimes.com/2016/01/16/world/europe/french-drug-trial-hospitalization.html

The Celebrity Surgeon Who Used Love, Money, and the Pope to Scam an NBC News Producer Adam Ciralsky Vanity Fair 2016-01-31: http://www.vanityfair.com/news/2016/01/celebrity-surgeon-nbc-news-producer-scam

The Outcome of My Clinical Trial Is a Mystery Emma Yasinki The Atlantic 2016-01-11: http://www.theatlantic.com/health/archive/2016/01/clinical-trial-unpublished-results/423540/

Whatever Happened to Human Experimentation Carl Elliot Hastings Center Report 46 (2016): 1-4. DOI: 10.1002/hast.531 http://www.scribd.com/doc/294403973/Whatever-Happened-to-Human-Experimentation

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Last Updated on: 2016-08-04

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