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Bioethics and Research Protections News 2013

UK Committee Blasts Government Over Clinical Trial Disclosure Ed Silverman Pharmalot 2013-09-17 http://www.pharmalive.com/uk-committee-blasts-government-over-clinical-trial-disclosure

No Point in Testing Controversial Stem Cell Treatment, Italian Panel Says Laura Margottini Science News 2013-09-12 http://news.sciencemag.org/biology/2013/09/no-point-testing-controversial-stem-cell-treatment-italian-panel-says

Dr. Charles Schulz speaks about the suicide of Dan Markingson Carl Elliot Fear and Loathing in Bioethics Blog 2013-09-10 http://loathingbioethics.blogspot.com/2013/09/dr-charles-schulz-speaks-about-suicide.html

Of Conflicts and Clinical Trials: Researchers Report New Results Jennifer Couzin-Frankel Science News 2013-09-10 http://news.sciencemag.org/scientific-community/2013/09/conflicts-and-clinical-trials-researchers-report-new-results

St. Louis University Under Fire for Work with Doctor Who Infected AIDS Patients with Malaria Sam Levin Riverfront Times 2013-09-09 http://blogs.riverfronttimes.com/dailyrft/2013/09/saint_louis_university_peter_heimlich_xiaoping_chen.php

Stem Cell Treatments Overtake Science Laura Beil New York Times 2013-09-09: http://www.nytimes.com/2013/09/10/health/stem-cell-treatments-overtake-science.html

Indian Parliament Comes Down Hard on Cervical Cancer Trial Pavalla Bagla Science News 2013-09-09: http://news.sciencemag.org/asiapacific/2013/09/indian-parliament-comes-down-hard-cervical-cancer-trial

Parliamentary panel on clinical trials seeks action against PATH Nikita Mehta Live Mint 2013-09-04: http://www.livemint.com/Politics/zC5KFSPu52aSCUCwzlXgNM/Parliamentary-panel-on-clinical-trials-seeks-action-against.html

Parliament of India Committee on Health and Family Welfare Alleged Irregularities in the Conduct of Studies Using Human Papilloma Virus (HPV) Vaccine By PATH in India August 30, 2013:

Activists hail report on HPV vaccines, but PATH says no violations Aarti Dhar The Hindu 2013-09-03: http://www.thehindu.com/news/national/activists-hail-report-on-hpv-vaccines-but-path-says-no-violations/article5086987.ece

Guesses and Hype Give Way to Data in Study of Education Gina Kolata New York Times 2013-09-02: http://www.nytimes.com/2013/09/03/science/applying-new-rigor-in-studying-education.html

Ethical questions linger in cervical-cancer study Bob Ortega The Arizona Republic 2013-08-31: http://www.usatoday.com/story/news/nation/2013/08/31/ethical-questions-linger-in-cervical-cancer-study/2751705/

Vinegar takes on killer Jyoti Shelar Mumbai Mirror 2013-07-21: http://articles.timesofindia.indiatimes.com/2013-07-21/health/40708170_1_vinegar-test-pap-smear-cervical-cancer

Simple vinegar test to prevent cervical cancer death Associated Press 2013-07-07: http://timesofindia.indiatimes.com/life-style/health-fitness/health/Simple-vinegar-test-to-prevent-cervical-cancer-death/articleshow/20405893.cms

ASCO Post 2013-07-13: http://am.asco.org/vinegar-screening-could-slash-cervical-cancer-mortality-one-third-low-resource-countries

ASCO 2013 Tata Memorial Centre, Mumbai, India: Effect of visual inspection with acetic acid (VIA) screening by primary health workers on cervical cancer mortality: A cluster randomized controlled trial in Mumbai, India Surendra Shastri 2013-06-02: http://www.youtube.com/watch?v=abx0Ysw-PJA

OHRP Determination Letter to Tata Memorial Hospital 2013-07-16: http://www.hhs.gov/ohrp/detrm_letrs/YR13/jul13c.pdf

OHRP Determination Letter to Tata Memorial Hospital 2013-01-17: http://www.hhs.gov/ohrp/detrm_letrs/YR13/jan13a.pdf

OHRP Determination Letter to Tata Memorial Hospital 2012-10-15: http://www.hhs.gov/ohrp/detrm_letrs/YR12/oct12a.pdf

OHRP Determination Letter to Tata Memorial Hospital 2012-07-05 (failure to obtain informed consent, failure to provide material information to subjects, failure to conduct continuing review of research, failure to maintain or provide IRB minutes, failure to record IRB minutes in sufficient detail, and failure to meet quorum of IRB members for at least one meeting): http://www.hhs.gov/ohrp/detrm_letrs/YR12/jul12d.pdf


U.S. Weighs Informed Consent Rules in Wake of Infant Study Controversy Arthur Allen AAAS Science News 2013-08-30: http://news.sciencemag.org/health/2013/08/u.s.-weighs-informed-consent-rules-wake-infant-study-controversy

Preemie study sparks debate over risks of research Lauran Neergaard Associated Press 2013-08-29: http://www.sfgate.com/news/science/article/Preemie-study-sparks-debate-over-risks-of-research-4770125.php

SUPPORT Study HHS Public Meeting 2013-08-28 video on YouTube: https://www.youtube.com/playlist?list=PLrl7E8KABz1Gc_ndt9grGg8O_jE5G1RNC&feature=edit_ok

SUPPORT Study HHS Public Meeting 2013-08-28 Transcript http://www.hhs.gov/ohrp/newsroom/rfc/Public%20Meeting%20August%2028,%202013/supportmeetingtranscriptfinal.html

Public Meeting transcript PDF http://www.hhs.gov/ohrp/newsroom/rfc/Public%20Meeting%20August%2028,%202013/supportmeetingtranscriptfinal.pdf

HHS Public Meeting Resource Page: http://www.hhs.gov/ohrp/newsroom/rfc/Public%20Meeting%20August%2028,%202013/aug28public.html

(Submit comments) SUPPORT Study: HHS Public Meeting Regarding Application of Regulatory Requirements at 45 CFR Part 46 to Research Studying Standard of Care Interventions Docket ID: HHS-OPHS-2013-0004 http://www.regulations.gov/#!docketDetail;D=HHS-OPHS-2013-0004

Judging Souls Versus Acts in Bioethics Alice Dreger Impact Bioethics Blog 2013-09-11 http://impactethics.ca/2013/09/11/judging-souls-versus-acts-in-bioethics/

SUPPORT Study consent forms: http://www.circare.org/consents/support-study-consent-form.pdf [Courtesy of Public Citizen Health Research Group]

SUPPORT Study protocol : http://www.circare.org/consents/support-study-protocol_20050328.pdf

Public Citizen Health Research Group Letter to the FDA Regarding Use of Experimental Pulse Oximeter Devices in the SUPPORT Study 2013-08-02: http://www.citizen.org/hrg2146

PHS Appeal No.: 11-0303, Response 2011-08-17: http://www.circare.org/info/phs-appeal_11-0303_20110817.pdf (We combined the two jpeg files osted at http://retinopathyofprematurity.org/110817from%20FOIA%20at%20DHHS%20on%20ROP.jpg and http://retinopathyofprematurity.org/110817from%20FOIA%20at%20DHHS%20on%20ROPpage2.jpg )

UC Davis surgeons resign after bacteria-in-brain dispute Marjie Lundstrom Sacramento Bee 2013-08-25: http://www.sacbee.com/2013/08/25/5678851/uc-davis-surgeons-resign-after.html

UCD Muizelaar investigation: http://media.sacbee.com/smedia/2013/08/23/17/54/rDxW0.So.4.PDF

UCD Schrot investigation: http://media.sacbee.com/smedia/2013/08/23/17/56/RYQ6X.So.4.PDF

UCD Improvement plan: http://media.sacbee.com/smedia/2013/08/24/15/08/udRUC.So.4.PDF

Report to the provost panel: http://media.sacbee.com/smedia/2013/08/24/15/06/1rgDqO.So.4.PDF

Provost letter to Chancellor Katehi: http://media.sacbee.com/smedia/2013/08/24/15/06/1j3Y07.So.4.PDF

Dr. Rudolph Schrot statement: http://media.sacbee.com/smedia/2013/08/24/15/05/1luiUE.So.4.PDF

Dr. J. Paul Muizelaar statement: http://media.sacbee.com/smedia/2013/08/24/15/04/Drdq0.So.4.PDF

New NIH-Funded Study on Premature Infants Shows Familiar Lack of Compliance With Ethical Consent Standards Public Citizen Health Research Group Press Release 2013-08-22: http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3965

In Wake of Controversy Over Unethical NIH-Funded Premature Baby Trial, HHS Seeks Way Forward Public Citizen Health Research Group Press Release 2013-08-21: http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=3963

Subject to question Nature 2013-08-21: http://www.nature.com/news/subject-to-question-1.13573

Saint Louis University's medical research veep defends partnership with doctor who conducted medical atrocity on Chinese prisoners with AIDS Peter Heimlich Sidebar Blog 2013-08-15: http://www.the-sidebar.com/2013/08/saint-louis-universitys-medical.html

SLU defends Chinese malaria research Alan Scher Zagier Associated Press 2013-08-21: http://web.archive.org/web/20130822020315/http://www.sfgate.com/news/article/SLU-defends-Chinese-malaria-research-4749681.php

Chen X. et al. Procedure and clinical assessments of malariotherapy: recent experience in 20 HIV patients Chinese Medical Journal 2003;116(7):1016-1021 http://preview.tinyurl.com/mq65pu6

Review board discussions on this proposal were organized respectively by the Municipal Department of Health of Guangzhou, by the Provincial Department of Health of Guangdong and by the Provincial Committee of Science and Technology of Guangdong, China. A final approval of phase 1-2 studies of malariotherapy for HIV/AIDS was obtained from these three levels of review boards.

Chen X et al. Impact of acute vivax malaria on the immune system and viral load of HIV-positive subjects Chinese Medical Journal 2003;116(12):1810-1820 http://preview.tinyurl.com/kgjvthk

This study was approved by the review board of Guangdong Provincial Committee of Science and Technology (China), a scientific and ethic combination committee at the provincial level.

Chen X, Heimlich H et al. Phase-1 Studies of Malariotherapy for HIV Infection. Chin Med Sci J. 1999;14(4):224-8 http://www.bioethicswatch.org/foia/imt_cjms1999.pdf

Through a couple of institutional board discussions, a final approval of phase I studies (no more than 10 cases) of malariotherapy for HIV infection in Guangzhu was obtained from the board.

The board was the US-based Great Lakes College of Clinical Medicine Institutional Review Board (GLCCM IRB). This IRB appears to have been little more than a scam and was subject to FDA enforcement action in 2000. For details, see: http://www.circare.org/foia2/docs.htm#glccm. Dr. Chen's research supported by the Fogarty International Center grant for training supervised by Professor John Fahey at UCLA (both 2003 studies) should have reviewed and approved by the UCLA IRB, as SLU surely knows. UCLA reprimanded Professor Fahey for conducting research without IRB approval. Documents: http://www.circare.org/foia4/uclafoia_malariotherapy.htm For a discussion of what's wrong with this research, see: http://www.circare.org/malariotherapy4.htm


Blood ties Nature 2013-08-07: http://www.nature.com/news/blood-ties-1.13513

Breshan Collins et al. Civil No. 13CV00733 USDC Northern AL Third Amended Class Action Complaint and Jury Trial Demand 2013-06-21: http://www.circare.org/lex/13cv00733_10_20130621.pdf

Lawsuit says UAB study harmed premature babies Mike Oliver AL.com 2013-04-18: http://blog.al.com/spotnews/2013/04/lawsuit_says_uab_study_harmed.html

Public Citizen Health Research Group Letter to the Assistant Secretary for Health and the OHRP Director Regarding Neonatal Research Network Trials 2013-04-18: http://www.citizen.org/documents/2115.pdf

Oregon DOJ case means doctors could tell patients ties to drug, implant makers. Nick Budnick The Oregonian 2013-08-16: http://www.oregonlive.com/health/index.ssf/2013/08/oregon_case_suggests_patients.html

Declaration of Jonathan Moreno, Ph.D. (defendants' expert) 2012-07-23: http://www.scribd.com/doc/162952070/Jonathan-Moreno-affadavit-in-Biotronik-conflict-of-interest-case

Groundbreaking Oregon DOJ cases target doctors' failure to inform patients about device payments. Nick Budnick The Oregonian 2013-08-06: http://www.oregonlive.com/health/index.ssf/2013/08/groundbreaking_oregon_doj_case.html

Journal, Authors Defend Oxygen Saturation Trial John Gever MedPage Today 2013-04-18: http://www.medpagetoday.com/PublicHealthPolicy/ClinicalTrials/38551

An Ethical Breakdown Editorial New York Times 2013-04-16: http://www.nytimes.com/2013/04/16/opinion/an-ethical-breakdown-in-medical-research.html

Consent Forms in a Clinical Trial of Premature Babies The SUPPORT Investigators LTE New York Times 2013-04-18: http://www.nytimes.com/2013/04/19/opinion/consent-forms-in-a-clinical-trial-of-premature-babies.html

Drazen JM et al. Informed Consent and SUPPORT N Eng J Med 2013-04-17 : http://dx.doi.org/10.1056/NEJMe1304996

Carlo WA et al. Oxygen Saturation Targets in Extremely Preterm Infants N Engl J Med 2013-04-17: http://dx.doi.org/10.1056/NEJMc1304827

Supplementary Appendix SUPPORT Trial Informed Consent [also includes OHRP determination letter of 2013-03-07] 2013-04-17: http://www.nejm.org/doi/suppl/10.1056/NEJMe1304996/suppl_file/nejme1304996_appendix.pdf

SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network Target Ranges of Oxygen Saturation in Extremely Preterm Infants N Engl J Med 2010; 362:1959-1969: http://dx.doi.org/10.1056/NEJMoa0911781

Tarnow-Mordi WO et al. Target Ranges of Oxygen Saturation in Extremely Preterm Infants, Correspondence N Engl J Med 2010; 363:1285-1286: http://dx.doi.org/10.1056/NEJMc1007912

Wade RD et al. Antenatal Consent in the SUPPORT Trial: Challenges, Costs, and Representative Enrollment Pediatrics. 2010 July; 126(1): e215—e221: http://dx.doi.org/10.1542/peds.2009-3353

Crucial Studies, Fragile Subjects Sabrina Tavernese New York Times 2013-04-15: http://www.nytimes.com/2013/04/16/health/balancing-risks-and-benefits-in-clinical-trials.html

Feds say study of babies at UM, elsewhere should have disclosed risks. Carol Marbin Miller Miami Herald 2013-04-13: http://www.miamiherald.com/2013/04/10/3336419/feds-say-study-of-babies-at-um.html

Study of Babies Did Not Disclose Risks, U.S. Finds. Sabrina Tavernise New York Times 2013-04-09: http://www.nytimes.com/2013/04/11/health/parents-of-preemies-werent-told-of-risks-in-study.html

Office for Human Research Protections Determination Letter Regarding the SUPPORT Trial to University of Alabama at Birmingham 2013-03-07 : http://www.hhs.gov/ohrp/detrm_letrs/YR13/mar13a.pdf

Public Citizen Health Research Group Letter to Secretary of Health and Human Services Regarding Unethical Trial Involving Premature Infants 2013-04-13: http://www.citizen.org/hrg2111

what's new Sign Public Citizen's petition requesting action by the Secretary of Health and Human Services: http://www.citizen.org/sebelius-petition-informed-consent

Public Citizen Letter to Dr. Richard Marchase at the University of Alabama at Birmingham Criticizing His Misleading Statements to the Media Regarding the Unethical SUPPORT Study 2013-04-11: http://www.citizen.org/hrg2112

Watchdog agency criticizes ethics of study of premature infants David Brown Washington Post 2013-04-10: http://www.washingtonpost.com/national/health-science/watchdog-agency-criticizes-ethics-of-study-of-premature-infants/2013/04/10/bb124926-a205-11e2-9c03-6952ff305f35_print.html

Drug study recruiting at U of M questioned Jeremy Olson Star Tribune 2013-02-28: http://www.startribune.com/lifestyle/health/193447511.html

Follow this story: Fear and Loathing in Bioethics blog: http://loathingbioethics.blogspot.com/

If you're concerned about what happened to Dan Markingson in the CAFE trial, consider signing a petition asking Minnesota Governor Mark Dayton to investigate : https://www.change.org/petitions/governor-mark-dayton-of-minnesota-investigate-psychiatric-research-misconduct-at-the-university-of-minnesota-2

Community Alliance for Ethics in Minnesota Psychiatry: https://www.facebook.com/pages/Community-Alliance-for-Ethics-in-Minnesota-Psychiatry/377132245708063

Critics question 2 U.S.-funded cancer studies in India. Bob Ortega Arizona Republic 2013-02-20: http://www.usatoday.com/story/news/nation/2013/02/20/india-cancer-studies-ethics-questions/1932113/

OHRP Determination Letter to Tata Memorial Hospital 2013-01-13: http://www.hhs.gov/ohrp/detrm_letrs/YR13/jan13a.pdf

OHRP Determination Letter to Tata Memorial Hospital 2012-10-12: http://www.hhs.gov/ohrp/detrm_letrs/YR12/oct12a.pdf

OHRP Determination Letter to Tata Memorial Hospital 2012-07-12: http://www.hhs.gov/ohrp/detrm_letrs/YR12/jul12d.pdf

Editorial: UC Davis doctors took advantage of the vulnerable. Sacramento Bee 2013-02-16: http://www.sacbee.com/2013/02/15/5192102/uc-davis-doctors-took-advantage.html

Impact, ethics of surgery slammed. Marjie Lundstrom Sacramento Bee 2013-02-11: http://www.sacbee.com/2013/02/11/5180237/impact-ethics-of-surgery-slammed.html

UCD Leaves Family Bereft. Marjie Lundstrom Sacramento Bee 2013-02-09: http://www.sacbee.com/2013/02/09/5178352/ucd-surgery-leaves-family-bereft.html

Controversial stem-cell company moves treatment out of the United States. David Cyranowski Nature News 2013-01-30: http://www.nature.com/news/controversial-stem-cell-company-moves-treatment-out-of-the-united-states-1.12332

New federal report back off threat to cut UCD Med Center funding. Marjie Lundstrom Sacramento Bee 2013-01-16: http://www.sacbee.com/2013/01/16/5117662/new-federal-report-backs-off-threat.html

Editorial: Did UCD ignore wayward docs because of $$? Sacramento Bee 2012-12-13: http://www.sacbee.com/2012/12/13/5050588/did-ucd-ignore-wayward-docs-because.html


Last Updated: 2016-04-20

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