Text ::   Skip Nav ::

circare logo

Brochure Contact Home Privacy Site Map Terms of Use Tools

Link to CIRCARE Link To ::

Bioethics and Research Protections News February to December 2012

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


Last Updated: 2016-04-20

If you find the information on this page helpful please support CIRCARE with a tax-deductible contribution today. Because CIRCARE doesn't accept funds from pharmaceutical or medical device manufacturers, we depend on contributions from individuals like you to help us advocate for meaningful protection of human subjects in research. Find out more on our Support page

All material on this site © CIRCARE Incorporated (2002-2005) or as indicated. Single copies can be downloaded for personal education.   Adobe® Reader ::   ::

Valid HTML 4.01! Valid CSS!