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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

Whitewash: Inspector General Review of Agency Misconduct Ignores Serious Ethical Lapses by Senior HHS Officials; Congress Should Act Public Citizen Press Release 2014-09-16: http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=4281

Report of OIG Review of Allegations of Interference in OHRP Compliance Determination for SUPPORT (OIG Report OIG-12-14-04) Office of Inspector General 2014-09-15: http://oig.hhs.gov/reports-and-publications/portfolio/oig-12-14-04.pdf

The Office for Human Research Protections' Evaluation of the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (OIG Report OEI-01-14-00560) Office of Inspector General 2014-09-16: http://oig.hhs.gov/oei/reports/oei-01-14-00560.asp

Canadians deserve to know about side effects in drug trials: Editorial (Editorial) Toronto Star 2014-09-15: http://www.thestar.com/opinion/editorials/2014/09/15/canadians_deserve_to_know_about_side_effects_in_drug_trials_editorial.html

Canadians kept in dark about defective drugs David Bruser and Jesse McLean Toronto Star 2014-09-11: http://www.thestar.com/news/canada/2014/09/11/canadians_kept_in_dark_about_defective_drugs.html

Ivory Tower Phony? Sex, Lies and Fraud Alleged in W. Va. University Case Nona Willis Aronowitz and Tony Dokoupil NBC News 2014-09-10: http://www.nbcnews.com/news/us-news/ivory-tower-phony-sex-lies-fraud-alleged-w-va-university-n199491

Faculty members challenge panel reviewing U's human research Maura Lerner Star Tribune 2014-09-08: http://www.startribune.com/local/274422651.html

Faculty rip into U of M over new review of drug research program Robbie Feinberg City Pages 2014-09-09: http://blogs.citypages.com/blotter/2014/09/professors_rip_into_u_of_m_over_new_review_of_research_program.php

UMN professors concerned about review of human clinical studies Doug Belden Pioneer Press 2014-09-08: http://www.twincities.com/education/ci_26491891/umn-professors-concerned-about-clinic-studies-review

Group of U faculty voices concern over drug review Alex Friedrich Minnesota Public Radio 2014-09-08: http://blogs.mprnews.org/oncampus/2014/09/group-of-u-faculty-voices-concern-over-drug-review/

How Dr. Heimlich Maneuvered Hollywood Into Backing His Dangerous AIDS Cure Seth Abramovitch Hollywood Reporter 2014-08-14: http://www.hollywoodreporter.com/news/how-dr-heimlich-maneuvered-hollywood-725352

When Chicago Hope Dealt in Heimlich, Malariotherapy and AIDS Seth Abramovitch Hollywood Reporter 2014-08-14: http://www.hollywoodreporter.com/news/chicago-hope-dealt-heimlich-malariotherapy-725010

Why Are Dope-addicted, Disgraced Doctors Running Our Drug Trials? Peter Aldous Matter 2014-07-29: https://medium.com/matter/why-are-dope-addicted-disgraced-doctors-running-our-drug-trials-aff6d20843bf

FDA Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) Letter to Charles E. Runels, Jr., M.D. (CBER) 2008-08-27: http://www.circare.org/fdawls3/runels_20080827.pdf

Charles E. Runels, Jr., M.D. Alabama Board of Medicine Disciplinary File: http://www.circare.org/pd/runels_discpfiles.pdf

Related:Patient Advocacy Council, Inc. (CBER) 2007-02-01: http://www.circare.org/fdawls/pacirb_20070201.pdf

Patient Advocacy Council, Inc. Response to FDA Warning Letter. 2007-02-21: http://www.circare.org/fdawls/pac_wlresponse_20070221.pdf

FDA Response to Patient Advocacy Council, Inc. 2007-03-16: http://www.circare.org/fdawls/pac_fdaresponse_20070316.pdf

FDA Warning Letter to Lori A. Nesbitt, Pharm.D., Discovery Alliance (CDER, PEDS) 2001-07-06: http://www.circare.org/fdawls3/nesbitt_20010706.pdf

Patient Advocacy Council, Inc. Institutional Review Board: http://www.pacirb.com/

The Best-Selling, Billion-Dollar Pills Tested on Homeless People Carl Elliot Matter 2014-07-28: https://medium.com/matter/did-big-pharma-test-your-meds-on-homeless-people-a6d8d3fc7dfe

Texas medical board charges controversial cancer doctor Liz Szabo USA Today 2014-07-25: http://www.usatoday.com/story/news/nation/2014/07/24/new-charges-for-burzynski/13111483/

Editorial Expression of Concern: Experimental evidence of massive scale emotional contagion through social networks PNAS Social Science: www.pnas.org/cgi/doi/10.1073/pnas.1412469111 (Facebook study)

Facebook Doesn't Understand The Fuss About Its Emotion Manipulation Study Kashmir Hill Forbes 2014-06-29: http://www.forbes.com/sites/kashmirhill/2014/06/29/facebook-doesnt-understand-the-fuss-about-its-emotion-manipulation-study/

Even the Editor of Facebook's Mood Study Thought It Was Creepy Adrienne Lafrance The Atlantic 2014-06-28: http://www.theatlantic.com/technology/archive/2014/06/even-the-editor-of-facebooks-mood-study-thought-it-was-creepy/373649/

FDA gives controversial doc green light to restart work Liz Szabo USA Today 2014-06-25: http://www.usatoday.com/story/news/nation/2014/06/25/burzynski-trial-reopens/11353085/

Massive U.S. children's study needs major tweaks, report finds Jocelyn Kaiser ScienceInsider 2014-06-16: http://news.sciencemag.org/health/2014/06/massive-u-s-childrens-study-needs-major-tweaks-report-finds

INVESTIGATORS: U of M drug study criticism grows Jeff Baillon Fox News 2014-05-20: http://www.myfoxtwincities.com/story/25557069/investigators-u-of-m-drug-study-criticism-grows

E-mails reveal top health officials wrongfully influenced baby investigation Mark Greenblatt Scripps News 2014-05-20: http://www.theindychannel.com/news/e-mails-reveal-top-health-officials-wrongfully-influenced-baby-investigation-public-citizen

Public Citizen Health Research Group HHS and NIH FOIA records: http://www.citizen.org/hrg2201 Per HHS and NIH, the rights and welfare of human research subjects constitutes kerfluffle. Splendid. [Ed.]

Suba, EJ US-funded measurements of cervical cancer death rates in India: scientific and ethical concerns IJME [S.l.], apr. 2014. ISSN 0975-5691 : http://ijme.in/index.php/ijme/article/view/2072/4511

SANKARANARAYANAN, Rengaswamy et al. Response to article titled "US-funded measurements of cervical cancer death rates in India: scientific and ethical concerns" by Eric J Suba. Indian Journal of Medical Ethics, [S.l.], jun. 2014. ISSN 0975-5691. Available at: http://ijme.in/index.php/ijme/article/view/2092/4512. Date accessed: 26 Jun. 2014.

Suba, Eric J. Response by Eric Suba to Sankaranarayanan et al. Indian Journal of Medical Ethics, [S.l.], jun. 2014. ISSN 0975-5691. Available at: http://ijme.in/index.php/ijme/article/view/2094/4516. Date accessed: 26 Jun. 2014.

Markingson Case Update: How an institution can transform a request for an Independent Inquiry into another institutional procedural shield. Trudo Lemmens UT Faculty of Law Blog 2014-04-24: http://www.law.utoronto.ca/blog/faculty/markingson-case-update-how-institution-can-transform-request-independent-inquiry

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

Evaluation of UC Davis Medical Center's handling of neurosurgeons is scathing. Marjie Lundstrom Sacramento Bee 2012-12-23: http://www.sacbee.com/2012/12/23/5072625/evaluation-of-uc-davis-medical.html

The patients: 'Probiotic therapy' 2012-12-23: http://www.sacbee.com/2012/12/23/5072894/the-patients-probiotic-therapy.html

The report: 'Serious deficiencies' 2012-12-23: http://www.sacbee.com/2012/12/23/5072893/the-report-serious-deficiencies.html

The Public Eye: Feds inspect UCD Medical Center in probe of questionable neurosurgeries. Marjie Lundstrom Sacramento Bee 2012-12-11: http://www.sacbee.com/2012/12/11/5045426/feds-inspect-ucd-medical-center.html

Federal regulators blast UC Davis Medical Center over experimental surgeries. Marjie Lundstrom Sacramento Bee 2012-12-08: http://www.sacbee.com/2012/12/08/5040127/federal-regulators-blast-uc-davis.html

Controversial UC Davis neurosurgeon goes on leave. Marjie Lundstrom Sacramento Bee 2012-12-07: http://www.sacbee.com/2012/12/07/5037669/controversial-uc-davis-neurosurgeon.html

Amid controversy, Claire Pomeroy to step down as UC Davis med school dean Marjie Lundstrom Sacramento Bee 2012-11-20: http://www.sacbee.com/2012/11/20/4998856/amid-controversy-claire-pomeroy.html

UC Davis doctors' actions spur investigation by accrediting agency Marjie Lundstrom Sacramento Bee 2012-11-10: http://www.sacbee.com/2012/11/10/4975281/uc-davis-doctors-actions-spur.html

Alternative therapy produces intriguing results in some heart patients but many questions remain American Heart Association Press Release 2012-11-04: http://newsroom.heart.org/pr/aha/alternative-therapy-produces-intriguing-240492.aspx

The Trial to Assess Chelation Therapy (TACT) Gervasio Lamas, M.D. AHA Slides 2012-11-04: http://www.circare.org/tact/LBCT01-04-TACT-Slides-11-2-12 copy.pdf

Trial to Assess Chelation Therapy (TACT) Quality of Life Outcomes Daniel Mark, M.D., M.P.H. AHA Slides 2012-11-04: http://www.circare.org/tact/LBCT02-03-TACTQoL-slides-10-26-12.pdf

Trial to Assess Chelation Therapy AHA 2012 LBT Commentary Paul W. Armstrong, M.D. 2012-11-04: http://www.circare.org/tact/TACT additionnaal slides.pdf

Clinical Implications of CPORT-E, TACT and FREEDOM Trials David O. Williams, M.D. AHA Slides 2012-11-04: http://www.circare.org/tact/TACT mmore slides.pdf

Doctors Debate Value of 'Fringe' Heart Treatment Marilynn Marchione AP 2012-11-04: http://www.salon.com/2012/11/05/doctors_debate_value_of_fringe_heart_treatment/

Doctors Dismiss Study That Says Chelation Helps Heart Patients Matthew Herper Forbes 2012-11-04: http://www.forbes.com/sites/matthewherper/2012/11/04/civil-war-a-study-says-chelation-might-help-heart-patients-but-doctors-dont-believe-it/

Study finds heart chelation therapy effective but raises questions. Elizabeth Cohen and John Bonifield CNN 2012-11-06: http://www.cnn.com/2012/11/04/health/chelation-heart-study/index.html?hpt=hp_t3

The Trial to Assess Chelation Therapy: Equivocal as Predicted Kim Atwood, M.D. Science Based Medicine 2012-11-04: http://www.sciencebasedmedicine.org/index.php/the-trial-to-assess-chelation-therapy-equivocal-as-predicted/

Researchers raise concerns over chelation heart study Liz Szabo USA Today 2012-11-04: http://www.usatoday.com/story/news/nation/2012/11/04/chelation-therapy-heart-disease/1678251/

FDA issues warning to Sugar Land stem cell company. Todd Ackerman Houston Chronicle 2012-10-16: http://www.chron.com/news/houston-texas/article/FDA-issues-warning-to-local-stem-cell-company-3953961.php

FDA Warning Letter to Celltex Therapeutics Corporation 2012-09-24: http://www.circare.org/fdawls2/celltex_fdawl_20120924.pdf

Celltex Therapeutics Corporation Response to FDA Warning Letter (redacted) 2012-10-16: http://www.circare.org/fdawls2/red_celltex_fdaresponse_20121016.pdf [courtesy of the Houston Chronicle]

FDA Warning Letter to Texas Applied Biomedical Services, aka TABS IRB 2012-09-24: http://www.circare.org/fdawls/tabsirb_fdawl_20120924.pdf

FDA Warning Letter to Texas Applied Biotechnology Research Review Committee, aka TABS IRB 2000-09-27: http://www.circare.org/fdawls/tabrrc_20000927.pdf

Additional information on adult stem cell experimentation

UC Davis researcher suspended over animal care allegations. Marjie Lundstrom Sacramento Bee 2012-10-07: http://www.sacbee.com/2012/10/07/4888452/uc-davis-researcher-suspended.html

FDA cites risk, but MS patients seek unproven therapy. Deena Beasley and Genevra Pittman Reuters 2012-10-05: http://www.reuters.com/article/2012/10/05/us-usa-health-ms-idUSBRE89416320121005

Lawsuits Against Stanford, Dr. Michael Dake for Experimental Procedures, Filed by San Francisco Firms Rouda Feder Tietjen & McGuinn and Emison Hullverson LLP. Press Release 2012-10-10: http://www.marketwatch.com/story/lawsuits-against-stanford-dr-michael-dake-for-experimental-procedures-filed-by-san-francisco-firms-rouda-feder-tietjen-mcguinn-and-emison-hullverson-llp-2012-10-10


Bad to the bone: A medical horror story Mina Kimes Forbes 2012-09-18: http://features.blogs.fortune.cnn.com/2012/09/18/synthes-norian-criminal/

Federal agency probes deaths of 3 UCD brain cancer patients Marjie Lundstrom Sacramento Bee 2012-09-06: http://www.sacbee.com/2012/09/06/4791800/federal-agency-probes-deaths-of.html

Why is Health Canada Still Allowing Quack Medicine to be Sold to Dangerous Psychotics? Marvin Ross Huffington Post 2012-08-20: http://www.huffingtonpost.ca/marvin-ross/health-canada-empowerplus_b_1811203.html

Davis neurosurgeon at center of controversy provokes critics and defenders Marjie Lundstrom Sacramento Bee 2012-08-19: http://www.sacbee.com/2012/08/19/4738284/davis-neurosurgeon-at-center-of.html

Ruling frees FDA to crack down on stem cell clinics Peter Aldhous New Scientist 2012-07- : http://www.newscientist.com/blogs/shortsharpscience/2012/07/ruling-frees-fda-to-crack-down.html

Regenerative Sciences, LLC, Christopher J. Centeno, M.D., et al. Civil No. 10CV1327 USDC District of Columbia Memorandum Opinion 2012-07-23: http://www.circare.org/lex/10cv1327_memopinion_20120723.pdf

2 UC Davis neurosurgeons accused of experimental surgery are banned from human research Marjie Lundstrom Sacramento Bee 2012-07-22: http://www.sacbee.com/2012/07/22/4648415/2-uc-davis-neurosurgeons-accused.html

(Ed.: words to live by) A renowned U.S. bioethicist, describing the alleged violations as a major penalty, said the university's IRB was right to intervene and quickly.

Arthur Caplan, director of medical ethics at New York University's Langone Medical Center, said that desperate people are especially vulnerable and need added protections.

If you're dying, you're kind of like reaching out to anything that anybody throws in front of you, said Caplan, who recently left the University of Pennsylvania's Center for Bioethics to assume the New York post.

That's why so many people over the years are pursuing quack cures in Mexico and all kinds of questionable treatments, he said, speaking in general terms. They're not able to think straight because they're at death's door.

Caplan said that institutional review boards are often misunderstood, with many people believing that such strenuous oversight is a lot of bureaucracy to get in the way of trying something to save lives.

In reality, he said, the committees are an essential safeguard for research subjects, who may not get an unbiased view on a researcher's consent form of the study's risks vs. benefits. Or, he said, subjects may be unaware of the financial interests a doctor or researcher might have in an experiment an aspect thoroughly vetted by an IRB.

Harris A. Lewin Vice Chancellor, Research University of California, Davis Letter to Patricia Holobough, U.S. Food and Drug Administration RE: Unauthorized Use of Biologic and Notification of Serious and Continuing Noncompliance 2011-10-17: http://www.circare.org/info/ucd/ucd_fda_20111017.pdf

Banned UCD doctor is one of UC's highest paid employees Marjie Lundstrom Sacramento Bee 2012-07-22: http://www.sacbee.com/2012/07/22/4648465/banned-ucd-doctor-is-one-of-ucs.html

Editorial: UC Davis doctor should step down as chair Sacramento Bee 2012-07-25: http://www.sacbee.com/2012/07/25/4657245/uc-davis-doctor-should-step-down.html

UC Davis chancellor orders review of university doctors' actions Marjie Lundstrom Sacramento Bee 2012-07-25: http://www.sacbee.com/2012/07/25/4657366/uc-davis-chancellor-orders-review.html

UC Davis neurosurgeon department chair steps down pending investigation into his research Marjie Lundstrom Sacramento Bee 2012-07-28: http://www.sacbee.com/2012/07/28/4668495/uc-davis-neurosurgeon-department.html

M.D. Anderson involved in trial of drug marketed by its president's company. Eric Berger and Todd Ackermann Houston Chronicle 2012-07-20: http://www.chron.com/news/houston-texas/article/M-D-Anderson-involved-in-trial-of-drug-marketed-3711441.php

Did Alternative Medicine Lead to Murder? Marvin Ross Huffington Post 2012-07-09: http://www.huffingtonpost.ca/marvin-ross/vitamin-tragedy_b_1650054.html

Woman Sues Pfizer For Alleged Injury In A Trial. Ed Silverman Pharmalot Blog 2012-07-09: http://www.pharmalot.com/2012/07/woman-sues-pfizer-for-alleged-injury-in-a-trial/

Candace Melissa Stewart Civil No. 1206-07852 OR Circuit Court Multinomah County. Complaint 2012-06-20: http://www.circare.org/lex/1206-07852_complaint_20120620.pdf

More information about Tanezumab trials : http://www.circare.org/info/tanezumab.htm

FDA Did Not Approve Regenicin Skin Graft. Adam Feuerstein TheStreet.com 2012-06-13: http://www.thestreet.com/story/11579041/1/fda-did-not-approve-regenicin-skin-graft.html

Regenicin Inc. (OTC-RGIN) PermaDerm and CEO. BioPharm Catalyst 2011-01-31: http://www.biopharmcatalyst.com/2011/01/regenicin-inc-otc-rgin-permaderm-and-ceo/

PermaDerm™ Timeline, Shriner Skin Study Audit. Sandy Frost Newsvine : http://sandyfrost.newsvine.com/_news/2010/11/09/5432854-permaderm-tm-timeline-shriner-skin-study-audit-findings

Use of electrical device on state hospital patients draws scrutiny Andrea Ball Austin Statesman 2012-05-19: http://www.statesman.com/news/statesman-investigates/use-of-electrical-device-on-state-hospital-patients-2365439.html

Groups cast doubt on validity of state hospital's electrotherapy consent forms Andrea Ball Austin Statesman 2012-05-31: http://www.statesman.com/news/texas-politics/groups-cast-doubt-on-validity-of-state-hospitals-2385232.html?printArticle=y

Records: State officials were told of electrotherapy study at psychiatric hospital Andrea Ball Austin Statesman 2012-06-06: http://www.statesman.com/news/statesman-investigates/records-state-officials-were-told-of-electrotherapy-study-2395270.html

Doctor accused of unapproved research at state hospital quits Andrea Ball Austin Statesman 2012-06-12: http://www.statesman.com/news/texas-politics/doctor-accused-of-unapproved-research-at-state-hospital-2398527.html

Texas Department of State Health Services Letter to Allen Childs, M.D. RE: Notice of Possible Disciplinary Action 2012-06-07: http://www.circare.org/info/tdshs_childs_20120607.pdf

Texas Department of State Health Services Letter to Electromedical International, Inc. 2012-06-11: http://www.circare.org/info/tdshs_epi_20120611.pdf

Electromedical International, Inc. Statement : http://www.circare.org/info/epi_statesman.pdf

Insight: New doubts about prostate-cancer vaccine Provenge. Sharon Begley Reuters 2012-03-30: http://www.chicagotribune.com/health/sns-rt-us-provengebre82t074-20120329,0,2209852,full.story

University To Celltex: Prof Has Academic Freedom. Ed Silverman Pharmalot 2012-03-23: http://www.pharmalot.com/2012/03/university-to-celltex-professor-speaks-for-himself/

Follow the Celltex story on the CIRCARE website

Panel Calls for Closer Oversight of Biomarker Tests Jocelyn Kaiser ScienceInsider 2012-03-23: http://news.sciencemag.org/scienceinsider/2012/03/panel-calls-for-closer-oversight.html

Evolution of Translational Omics: Lessons Learned and the Path Forward Institute of Medicine National Academy of Science Press 2012-03-23: http://www.iom.edu/Reports/2012/Evolution-of-Translational-Omics.aspx

Disciplined doctors reap drug company benefits Lisa Chedekel The Middletown Press 2012-03-06: http://middletownpress.com/articles/2012/03/06/news/doc4f5566861adcc194757598.txt?viewmode=fullstory

In India, oversight lacking in outsourced drug trials. Tim Sandler NBC Dateline 2012-03-04: http://openchannel.msnbc.msn.com/_news/2012/03/04/10562883-in-india-oversight-lacking-in-outsourced-drug-trials

2012-03-05: links to video segments of the 2012-03-04 Dateline episode on drug trials are available on the MSNBC Dateline website at: http://www.msnbc.msn.com/id/3032600/

'People keep falling sick': How poor Indians are recruited for clinical drug trials Tim Sandler, NBC News 2012-03-02: http://openchannel.msnbc.msn.com/_news/2012/03/02/10561824-people-keep-falling-sick-how-poor-indians-are-recruited-for-clinical-drug-trials

FDA Warning Letter to Essex Institutional Review Board (CDER) 2011-07-26 [approval of fictitious protocol; additional]: http://www.circare.org/fdawls/essexirb_fdawl_20110726.pdf

Essex Institutional Review Board Form FDA 483 and Company Response 2011-04-11: http://www.circare.org/fdawls/essexirb_fdafoia_2011-6068.pdf

FDA Warning Letter to Essex Institutional Review Board (CDER, SUSP, PEDS) 1998-08-27 [Oflaxacin otic solution]: http://www.circare.org/fdawls/essexirb_19980827.pdf

Related: Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) to Eduardo Caro Acevedo, M.D. 1998-08-28 [Oflaxacin otic solution]: http://www.circare.org/fdawls3/acevedo_19980828.pdf

Eduardo Caro Acevedo, M.D.; Debarment Order 70 FR 15107 2005-03-24: http://www.circare.org/fdawls3/acevedo_20050324.pdf

FDA Warning Letter to Essex Institutional Review Board (CBER, PEDS) 2000-03-01 [Myoblast Transfer]: http://www.circare.org/fdawls/essexirb_20000301.pdf

Related: Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) to Peter K. Law, Ph.D. 2000-06-30 [Myoblast Transfer]: http://www.circare.org/fdawls3/law_20000630.pdf

Notice of Opportunity for Hearing (NOOH) to Peter K. Law, Ph.D. 2002-11-01: http://www.circare.org/fdawls3/law_20021101.pdf

Peter K. Law, Ph.D. Notice of Disqualification to Receive lnvestigational New Drugs 2006-10-26: http://www.circare.org/fdawls3/law_20061023.pdf

Waggoner, WC. Essex Institution Review Board Approval Letter to Bruce Frome, M.D. for study titled Ion Magnetic Induction Device (PAP-IMI-300) As An Immunomodulator in Treating Patients with AIDS. 1993-04-22: http://www.circare.org/pd/essexirb_19930422.pdf

Before the Medical Board of California in the Matter of the Second Amended Accusation Against Bruce M. Frome, M.D. Decision 2001-08-24: http://www.bioethicswatch.org/pd/frome_20010824.pdf

Kan. doctor faces sentencing for bogus research Roxana Hegeman Associated Press 2012-03-04: http://cjonline.com/news/2012-03-04/kan-doctor-faces-sentencing-bogus-research

Send Lawyers, Guns, and Stem Cells. Carl Elliott The Chronicle of Higher Education 2012-03-01: http://chronicle.com/blogs/brainstorm/send-lawyers-guns-and-stem-cells/44448

Slap: Pressure From Politically-Connected Stem Cell Firm Celltex Leads To Slate Retraction. The Antidote Blog William Heisel 2012-03-01: http://www.reportingonhealth.org/blogs/2012/03/01/slap-pressure-politically-connected-stem-cell-firm-celltex-leads-slate-retraction

Updated: Slate retracts story on Glenn McGee and Celltex following lawsuit threats, as McGee resigns from company. Retraction Watch 2012-03-01: http://retractionwatch.wordpress.com/2012/03/01/slate-retracts-story-on-glenn-mcgee-and-celltex-as-mcgee-resigns-from-company/

Vets feel abandoned after secret drug experiments. David S. Martin CNN 2012-03-01: http://www.cnn.com/2012/03/01/health/human-test-subjects/index.html

Veterans Subjected to Drug Experiments Still Bound by Secrecy Oaths Jeff Stein Spytalk Blog 2012-03-01: http://spytalkblog.blogspot.com/2012/03/veterans-subjected-to-unwitting-drug.html

Controversial bioethicist quits stem-cell company. David Cyranoski Nature News 2012-03-01: http://www.nature.com/news/controversial-bioethicist-quits-stem-cell-company-1.10151

Slate Withdraws The Celltex Affair. David Plotz Slate 2012-02-29: http://www.slate.com/articles/briefing/editors_note/2012/02/editor_s_note.html

Stem-cell therapy takes off in Texas. David Cyranoski Nature News 2012-02-29: http://www.nature.com/news/stem-cell-therapy-takes-off-in-texas-1.10133

Celltex is not just another stem cell company. Leigh Turner Health in the Global Village Blog 2012-02-28: http://www.healthintheglobalvillage.com/?p=647

The Celltex Affair An ethics scandal strikes the world of bioethics. Carl Elliot Slate 2012-02-17: http://www.slate.com/articles/health_and_science/medical_examiner/2012/02/glenn_mcgee_and_celltex_an_ethics_scandal_in_bioethics_.html

Stem Cell Treatment Monitor Blog http://sctmonitor.blogspot.com/

JAMA awaiting final OHRP decision on Harvard-led paper whose authors didn't fully disclose risks to elderly. Retraction Watch 2012-02-27: http://retractionwatch.wordpress.com/2012/02/27/jama-awaiting-final-ohrp-decision-on-harvard-led-paper-whose-authors-didnt-fully-disclose-risks-to-elderly/

What's In a Name? Ruth Sanders BioNews 2012-02-27: http://www.bionews.org.uk/page_128145.asp

Largent A, Grady C. Miller FG, Wertheimer A. Money, Coercion, and Undue Inducement: Attitudes about Payments to Research Participants. IRB: Ethics & Human Research 2012 January-February. Accessed on 2012-02-29 at: http://www.thehastingscenter.org/Publications/IRB/Detail.aspx?id=5705

Harvard-affiliated aging research center must explain hip-fracture risk to study participants. Boston Globe Kay Lazar 2012-02-22: http://www.boston.com/Boston/whitecoatnotes/2012/02/harvard-led-research-team-ordered-explain-risks-elderly-nursing-home-residents-study/HpUwYuSW9NrvhoxXb1cxJO/index.html

OHRP Determination Letter to Hebrew Rehabilitation Center for the Aged/University of Maryland, Baltimore, School of Medicine/Washington University 2012-02-17: http://www.hhs.gov/ohrp/detrm_letrs/YR12/feb12a.pdf

OHRP Determination Letter to Hebrew Rehabilitation Center for the Aged/University of Maryland, Baltimore, School of Medicine/Washington University 2011-06-23: http://www.hhs.gov/ohrp/detrm_letrs/YR11/jun11a.pdf

Obama Reappoints Gutmann to Bioethics Commissions (sic). Seth Zweifler The Daily Pennsylvanian 2012-02-19: http://thedp.com/index.php/article/2012/02/obama_reappoints_gutmann_to_bioethics_commissions

Lawyer: 6 clients say they were injected as kids with malaria at Austrian clinic. Associated Press 2012-02-09: http://www.washingtonpost.com/world/europe/lawyer-6-clients-say-they-were-injected-as-kids-with-malaria-at-austrian-clinic/2012/02/09/gIQA3ios1Q_story.html

Human experiments: First, do harm. Matthew Walter Nature News 2012-02-08: http://www.nature.com/news/human-experiments-first-do-harm-1.9980

Behind Closed Doors Mitch Smith Inside HigherEd 2012-02-08: http://www.insidehighered.com/news/2012/02/08/author-provides-inside-look-irbs

Fears of children infected with malaria. Vienna Times Online 2012-02-07: http://www.viennatimes.at/news/General_News/2012-02-07/28039/Fears_of_children_infected_with_malaria

Fallout From Fatigue Syndrome Retraction Is Wide. David Tuller. New York Times 2012-02-06: http://www.nytimes.com/2012/02/07/health/fallout-from-fatigue-syndrome-retraction-is-far-and-wide.html?pagewanted=all

Working the Assembly Line at the Human Experimentation Factory. Carl Elliot The Chronicle of Higher Education 2012-02-01: http://chronicle.com/blogs/brainstorm/working-the-assembly-line-at-the-human-experimentation-factory/43646

Allergan Erases Doctor Payment Records. Charles Ornstein and Tracy Weber. ProPublica 2012-02-01: http://www.propublica.org/article/allergan-erases-doctor-payment-records


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