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Index of (In)Famous Research and High Profile Cases

2009-03-11: We appreciate your patience while we update this page.

WARNING: some of these links lead to graphic upsetting material.

The Tuskegee Study

Final Report of the Tuskegee Syphilis Study Ad Hoc Advisory Panel. Accessed on 2008-10-19 at: http://biotech.law.lsu.edu/cphl/history/reports/tuskegee/tuskegee.htm (Courtesy of Edward P. Richards, III, JD, MPH, and the Medical and Public Health Law Site, Louisiana State University Law School)

Bad Blood: The Troubling Legacy of the Tuskegee Syphilis Study. University of Virginia Health Sciences Library, Historical Collections. 2004-06-23. Accessed on on 2006-05-07 at: http://www.med.virginia.edu/hs-library/historical/apology/index.html

Rivers E, Schuman SH, Simpson L, Olansky S. Twenty Years of Followup Experience in a Long-Range Medical Study. Public Health Reports. 1953;68(4):391-395. Accessed on 2009-03-11 at: http://facstaff.gpc.edu/~shale/humanities/composition/assignments/experiment/rivers.html

Center for Disease Control (CDC) Tuskegee Syphilis Study Page. 2005-11-17. Accessed on 2006-05-07 at: http://www.cdc.gov/nchstp/od/tuskegee/index.html

National Library of Medicine Finding Aid to the Documents on the Origin and Development of the Tuskegee Syphilis Study, 1921-1973. 2004. Accessed on 2006-05-07 at: http://www.nlm.nih.gov/hmd/manuscripts/ead/tuskegee264.html

The Tuskegee Syphilis Study Internet Resources. Accessed on 2009-03-11 at: http://facstaff.gpc.edu/~shale/humanities/composition/assignments/experiment/tuskegee.html (Courtesy of Professor Steven Hale, Georgia Perimeter College)

Nazi Research

The text of the indictment that began the trials at Nuremberg is preserved at the United States Holocaust Museum: The Doctors Trial, The Medical Case of the Subsequent Nuremberg Proceedings, from the official trial record: Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg, October 1946 – April 1949, Washington, D.C.: U.S. G.P.O, 1949 – 1953. Accessed on 2006-05-07 at: http://www.ushmm.org/research/doctors/indiptx.htm

The Doctors Trial: The Medical Case of the Subsequent Nuremberg Proceedings. United States Holocaust Museum. Undated. Accessed on 2006-05-07 at: http://www.ushmm.org/research/doctors/

Nuremberg Trials Project A Digital Document Collection — Harvard Law School Library. July, 2003. Accessed on 2006-05-07 at: http://nuremberg.law.harvard.edu/php/docs_swi.php?DI=1&text=overview

Nazi Research in World War II. Medical Experiments I: Mass Sterilization; Medical Experiments II: Freezing, Low Pressure And Others. Undated. Accessed on 2006-05-07 at: http://facultystaff.vwc.edu/~dgraf/nazidocs.txt (Courtesy of Professor Daniel Graf, Department of History, Virginia Wesleyan University.)

Porton Down, U.K. Ministry of Defense: Porton Down Volunteers (Main Index). Ministry of Defense. June, 2006. Accessed on 2009-03-12 at: http://www.mod.uk/DefenceInternet/AboutDefence/WhatWeDo/HealthandSafety/PortonDownVolunteers/

Albert Kligman M.D., Dermatology Research at Holmsberg Prison: Goldfarb NM. Ackerman on Kligman: A Shameful Story in American Clinical Research. Journal of Clinical Research Best Practices. 2006;2(4). Accessed on 2006-05-07 at: http://www.firstclinical.com/resources/journal/0604/Ackerman.pdf

Hornblum AM. Acres of Skin. 1998. In: Journal of Clinical Research Best Practices. 2006;2(4). Accessed on 2006-05-07 at: http://www.firstclinical.com/resources/journal/0604/Acres.pdf

Research subjects protest prof. Elizabeth Rossi. The Daily Pennsylvanian. 2003-10-30: http://media.www.dailypennsylvanian.com/media/storage/paper882/news/2003/10/30/News/Research.Subjects.Protest.Prof-2153312.shtml

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Pfizer's Clinical Trial of Trovan in Kano, Nigeria: Panel Faults Pfizer in '96 Clinical Trial In Nigeria. Joe Stephens. The Washington Post. 2006-05-06. Accessed on 2006-10-19 at: http://www.washingtonpost.com/wp-dyn/content/article/2006/05/06/AR2006050601338.html

Report of the Investigation Committee on the Clinical Trial of Trovafloxacin (Trovan) by Pfizer, Kano, 1996. Federal Ministry of Health. 2001-03: http://www.circare.org/info/trovan_clinicaltrialreport.pdf Originally accessed on 2006-10-19 at: http://www.washingtonpost.com/wp-srv/world/documents/Clinical_Trial_Report.pdf

Nigeria court seeks 3 arrests in Pfizer drug trial. Reuters. 2007-12-24: http://africa.reuters.com/top/news/usnBAN454820.html

Pfizer arrests sought in Nigeria. BBC News. 2007-12-24: http://news.bbc.co.uk/2/hi/business/7159671.stm

Pfizer: Court Orders Arrest of MD, 2 Others. Ibrahim Shuaibu. This Day. 2007-12-25: http://www.thisdayonline.com/nview.php?id=98890

05-4863-cv (L), 05-6768-cv (CON) Rabi Abdullahi v. Pfizer, Inc. United States Court of Appeals for the Second Circuit. 2009-01-30: http://www.circare.org/lex/05-4863-cv_opn.pdf

Trovan Tablets & Trovan I.V. (Trovafloxacin Mesylate & Alatrofloxacin Mesylate) Company: Pfizer Application No.: 20-759 & 20-760 Approval Date: 12/18/1997. Accessed on 2009-03-11 at: http://www.fda.gov/cder/foi/nda/97/020760a.htm

Nicole Wan, University of Rochester: Case Report on Death of University of Rochester Student Issued. New York State Department of Health. 1996-09-26. Accessed on 2009-03-11 at: http://www.health.state.ny.us/press/releases/1996/wan.htm

Rochester Death Halts MIT-Funded Study. Dan McGuire. The Tech. 1996-04-09. Accessed on 2009-03-11 at: http://tech.mit.edu/V116/N17/rochester.17n.html

Student dies at Rochester in MIT-based study. Massachusetts Institute of Technology News Release. 1996-04-10. Accessed on 2009-03-11 at: http://web.mit.edu/newsoffice/1996/wandeath-0410.html

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Ellen Roche, Johns Hopkins University: Johns Hopkins Bayview Medical Center IRB Protocol Approval Notice RE: AAC00-07-26-02, Mechanisms of Deep Inspiration-Induced Airway Relaxation. 2000-09-10: http://www.circare.org/info/AAC00-07-26-02_protocol.pdf Originally accessed on 2009-03-11 at: http://web.archive.org/web/20020124172231/http://www.hopkinsmedicine.org/protocol.pdf

OHRP Determination Letter to Johns Hopkins University. 2001-07-19. Accessed on 2009-03-11 at: http://www.hhs.gov/ohrp/detrm_letrs/jul01a.pdf

Johns Hopkins University Letter to OHRP. The Baltimore Sun. 2001-07-13. Accessed on 2009-03-11 at: http://web.archive.org/web/20010916035943/http://www.baltimoresun.com/bal-hopkinsletters.htmlstory

Hopkins responds to OHRP suspension of research. Undated: http://web.archive.org/web/20020311113316/www.baltimoresun.com/bal-hopkinsreacts.story

FDA Warning Letter to Alkis Togias, M.D. 2003-03-31: http://www.circare.org/fdawls3/togias_20030331.pdf

Form FDA 483 Issued to Alkis Togias, M.D. 2001-06-28: http://www.circare.org/fdawls3/togias483_20010628.pdf

Johns Hopkins University Response to FDA. 2001-07-16: http://www.hopkinsmedicine.org/press/2001/july/togiasletter.htm

Form FDA 483 Issued to Chi Van Dang, M.D. and John Hopkins School of Medicine IRB. 2001-09-07: http://www.circare.org/fdawls3/jhuirb_483.pdf

Form FDA 483 Issued to Chi Van Dang, M.D. and John Hopkins Bayview Medical Center, Human Subjects Committee. 2001-09-07: http://www.circare.org/fdawls3/bayviewmc_483.pdf

JHU Report of Internal Investigation Into the Death of a Volunteer Research Subject. Undated. Accessed on 2009-03-11 at: http://www.hopkinsmedicine.org/press/2001/JULY/report_of_internal_investigation.htm

External Review Committee Report. 2001-08-08: http://www.circare.org/info/jhu_externalcmte_20010808.pdf Originally accessed on 2009-03-11 at: http://web.archive.org/web/20020123031918/http://www.hopkinsmedicine.org/external.pdf

External Review Committee Submits Report, Addendum to Hopkins. JHU Press Release. 2001-08-29. Accessed on 2009-03-11 at: http://www.hopkinsmedicine.org/press/2001/august/010829.htm

External Review Committee Report Addendum. 2001-08-21. Accessed on 2009-03-11 at: http://web.archive.org/web/20020124074431/http://www.hopkinsmedicine.org/addendum.pdf

Selected Comments of Alkis Togias, M.D. on JHU Report of Internal Investigation Into the Death of a Volunteer Research Subject. Undated. Accessed on 2009-03-11 at: http://web.archive.org/web/20011107122835/http://www.hopkinsmedicine.org/comments.htm

Additional documents available by searching for Ellen Roche at: http://www.hopkinsmedicine.org/

[dead link] Hopkins faults safety lapses. Jonathan Bor and Tom Pelton. The Baltimore Sun. 2001-07-17: http://www.baltimoresun.com/news/nation/bal-te.md.hopkins17jul17,0,7764652,full.story

U.S. to Investigate Death in an Asthma Study. Lawrence K. Altman. The New York Times. 2001-06-16: http://query.nytimes.com/gst/fullpage.html?res=9507E2DD1531F935A25755C0A9679C8B63

Asthma study patient who died worked at Hopkins lab. Tom Pelton, Jonathan Bor, and Gary Cohn. The Baltimore Sun. 2001-07-17: http://web.archive.org/web/20010911183539/http://www.baltimoresun.com/features/health/sns-health-testingdeath.story

Hopkins panel to study death of volunteer. Jonathan Bor. The Baltimore Sun. 2001-06-23: http://web.archive.org/web/20010911181907/http://www.baltimoresun.com/news/health/bal-panel.story

Asthma study violated safety rules, FDA says. Tom Pelton. The Baltimore Sun. 2001-07-03: http://web.archive.org/web/20020113053747/http://www.baltimoresun.com/news/health/bal-fdastory.story

Respected doctors confront a tragedy. Tom Pelton. The Baltimore Sun. 2001-07-08: http://web.archive.org/web/20010911182135/http://www.baltimoresun.com/bal-te.hopkins08jul08.story

U.S. halts Hopkins research. Jonathan Bor and Tom Pelton. The Baltimore Sun. 2001-07-20: http://web.archive.org/web/20010911182845/http://www.baltimoresun.com/bal-te.hopkins20jul20.story

Hopkins vows to improve research safety. Tom Pelton and Jonathan Bor. The Baltimore Sun. 2001-07-21: http://web.archive.org/web/20020113055012/http://www.baltimoresun.com/bal-te.md.hopkins21jul21.story

U.S. eases constraints on Hopkins. Jonathan Bor and Tom Pelton. The Baltimore Sun. 2001-07-24: http://web.archive.org/web/20020211231904/http://www.baltimoresun.com/bal-te.md.hopkins24jul24.story

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Michael J. McGee, M.D., University of Oklahoma: Human Guinea Pigs. Time Magazine. Michael D. Lemonick and Andrew Goldstein. 2002-04-22. Accessed on 2009-03-11 at: http://www.time.com/time/covers/1101020422/story.html

OHRP Determination Letter to University of Oklahoma Health Sciences Center. 2000-07-13. Accessed on 2009-03-11 at: http://www.hhs.gov/ohrp/detrm_letrs/jul00e.pdf

FDA Notice of Initiation of Disqualification Proceedings and Opportunity to Explain to Michael J. McGee, M.D. 2001-06-21: http://www.fda.gov/foi/nidpoe/n16l.pdf

FDA Notice of Opportunity for Hearing to Michael J. McGee, M.D. 2002-05-21: http://www.fda.gov/foi/nooh/mcgee.pdf

Safeguards proposed for clinical trials. Katherine Pfleger. The Seattle Times. 2002-04-24. Accessed on 2009-03-11 at: http://community.seattletimes.nwsource.com/archive/?date=20020424&slug=trials24m

Senate Committee on Health, Education, Labor, and Pensions. Protecting Human Subjects in Research: Are Current Safeguards Adequate? 2002-04-23. Accessed on 2009-03-11 at: http://help.senate.gov/Hearings/2002_04_23_a/2002_04_23_a.html

S. Hrg. 107-424 Protecting Human Subjects in Research: Are Current Safeguards Adequate? Subcommittee on Public Health of the Senate Committee on Health, Education, Labor, and Pensions. 107th Congress Second Session. 2002-04-23. Accessed on 2009-03-11 at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=107_senate_hearings&docid=f:79325.pdf

Statement of Cherlynn Mathias, R.N. Before the Senate Committee on Health, Education, Labor, and Pensions. 2002-04-23: http://www.circare.org/submit/230402Ch.pdf

Gage Stevens, University of Pittsburgh: Kids as guinea pigs. Dawn MacKeen. Salon. 2000-05-31. Accessed on 2009-03-11 at: http://archive.salon.com/health/feature/2000/05/31/drug_trials/

A Heartburn Drug, Now Linked to Children's Deaths. David Willman. The Los Angeles Times. 2000-12-20. Accessed on 2009-03-11 at: http://www.pulitzer.org/archives/6474

FDA Criticized For Delay Pulling Drug. CBS Evening News. 2000-04-26. Accessed on 2009-03-11 at: http://www.cbsnews.com/stories/2000/04/26/eveningnews/main189083.shtml

Janssen Pharmaceutica Stops Marketing Cisapride in the U.S. FDA Talk Paper. 2000-03-23. Accessed on 2009-03-11 at: http://www.fda.gov/bbs/topics/ANSWERS/ANS01007.html

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Clinical Trials Testing LSD: LSD Reports from the U.S. Military. Various dates. Accessed on 2006-05-07 at: http://www.thememoryhole.org/mil/mil_lsd_reports/ (FOIA documents courtesy of The Memory Hole.)

Radiation Experiments: ACHRE Report. Advisory Committee on Human Radiation Experiments, U.S. Department of Energy. Undated. Accessed on 2009-03-12 at: http://www.hss.energy.gov/HealthSafety/ohre/roadmap/achre/index.html

The Studies at the Fernald School. ACHRE Report, Chapter 7. Advisory Committee on Human Radiation Experiments, U.S. Department of Energy. Accessed on 2009-03-12 at: http://www.hss.energy.gov/HealthSafety/ohre/roadmap/achre/chap7_5.html

Fred Hutchinson Cancer Research Center Uniformed Consent. Duff Wilson and David Heath. The Seattle Times. 2001-03-11 to 15. Accessed on 2009-03-11 at: http://seattletimes.nwsource.com/uninformed_consent/

Documents from litigation against the Fred Hutchinson Cancer Research Center. Various dates. Accessed on 2009-03-12 at: http://www.sskrplaw.com/gene/wright/evidence.html (Courtesy of SSKRP Attorneys at Law.)

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James Holland, M.D., Paul Kornak, Stratton VA Medical Center: Paul H. Kornak pled guilty today, in United States District Court in Albany, to making a false statement, mail fraud, and criminally negligent homicide. U.S. Department of Justice Press Release. 2005-01-18: http://www.usdoj.gov/usao/nyn/NewsReleases/2005/2005-02/200502031553.htm

Paul H. Kornak. Criminal No. 03CR436, USDC, N.D. of N.Y. (Plea and Cooperation Agreement) 2005-01-19: http://www.circare.org/lex/03cr436.pdf

NOT-OD-06-042 Findings of Scientific Misconduct (Paul H. Kornak). Department of Health and Human Services (DHHS). 2006-02-24: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-042.html

FDA Notice of Initiation of Disqualification Proceedings and Opportunity to Explain to James A. Holland, M.D. 2004-09-22: http://www.fda.gov/foi/nidpoe/n32l.pdf

Form FDA 483 Issued to James A. Holland M.D. Stratton VA Medical Center. 2003-01-02: http://www.bioethicswatch.org/foia/strattonva483_20030102.pdf

James A. Holland, M.D. Criminal No. 07CR202, USDC, N.D. of N.Y. (Criminal Information) 2007-04-24: http://www.circare.org/lex/07cr202_20070424.pdf

James A. Holland, M.D. Criminal No. 07CR202, USDC, N.D. of N.Y. (Plea Agreement) 2007-04-24: http://www.circare.org/lex/07cr202_plea.pdf

James A. Holland, M.D. Criminal No. 07CR202, USDC, N.D. of N.Y. (Sentencing Memorandum) 2008-03-17: http://www.circare.org/lex/07cr202_20080317.pdf

James A. Holland, M.D. Physician Profile. Georgia Composite State Board of Medical Examiners. Accessed on 2009-03-12 at: https://www.gaphysicianprofile.org/profile.ShowProfileAction.action?lic_nbr=053243

Jayne Steubing, individually and as Personal Representative of Carl Steubing, and all others similarly situated v. Paul Kornak and James Holland M.D. Case No. 03CV0332. Complaint and Motion for Class Action. USDC, N.D. of N.Y. 2003-03-18: http://www.circare.org/lex/03cv0332complaint_20030318.pdf

[Steubing] Consent Form for study titled Open Label, Randomized, Multicenter, Phase I/III Study of Docetaxel in Combination with Cisplatin (CDDP) or Docetaxel in Combination with 5-fluorouracil (5-FU) and CDDP Compared to the Combination of CDDP and 5-FU in Patients with Metastasis or Locally Recurrent Gastric Cancer Previously Untreated with Chemotherapy for Advanced Disease. Accessed on 2009-03-12 at: http://www.sskrplaw.com/gene/steubing/vaconsent.html (Courtesy of Alan Milstein, SSKR & P, Attorneys At Law.)

Widows' VA suit thrown out. Brendan J. Lyons. The Albany Times–Union. 2007-12-11: http://timesunion.com/AspStories/story.asp?storyID=646167&category=REGIONOTHER&BCCode=LOCAL&newsdate=12/11/2007

Court papers detail dark chapter at VA. Brendan J. Lyons. The Albany Times–Union. 2007-12-09: http://www.timesunion.com/AspStories/story.asp?storyID=645743&TextPage=1

Coercion used on patient, family says. Brendan J. Lyons. The Albany Times–Union. 2007-12-09: http://timesunion.com/AspStories/story.asp?storyID=645744&category=REGIONOTHER&BCCode=HOME&newsdate=12/9/2007

Docetaxel. Accessed on 2009-03-11 at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/

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Richard Borison, M.D., Bruce Diamond, Ph.D., and the Medical College of Georgia: Form FDA 483 Issued to Richard L. Borison M.D. 1997-04-22: http://www.bioethicswatch.org/foia/borison483_19970422.pdf

Richard L. Borison, M.D. FDA Docket No. 00N-1530: Proposal to Debar Notice of Opportunity for Hearing. 2002-11-22: http://www.fda.gov/ohrms/dockets/dailys/02/Dec02/121902/00n-1530.pdf

Department of Health and Human Services, Food and Drug Administration. Richard L. Borison M.D. Debarment Order. 68 FR 189 56299. 2003-09-30: http://www.fda.gov/OHRMS/DOCKETS/98fr/03-24656.pdf

Bruce I. Diamond, Ph.D. FDA Docket No. 00N-1531: Proposal to Debar Notice of Opportunity for Hearing. 2002-11-26: http://www.fda.gov/ohrms/dockets/dailys/02/Dec02/121902/00n-1531.pdf

Former VA psychiatrist sentenced to 15 years in jail. Office of Inspector General Department of Veterans Affairs (VAOIG) Press Release. 1998-10-09: http://www.va.gov/oig/51/press99/borison-pr.htm

Researcher pleads guilty in massive fraud. Office of Inspector General Department of Veterans Affairs (VAOIG) Press Release. 1997-12-16: http://www.va.gov/oig/51/press98/diamondpr.htm

Attorney General Announces Guily Plea in Medical College of Georgia Fraud Case. State of Georgia Attorney General Press Release. 1998-10-09: http://www.state.ga.us/ago/press/press.cgi?prfile=PR.19981009.01

Attorney General Announces Guily Plea in Medical College of Georgia Fraud Case. State of Georgia Attorney General Press Release. 1997-12-16: http://www.state.ga.us/ago/press/press.cgi?prfile=PR.19971216.01

Borison gets prison after guilty pleas. Sandy Hodson and Tom Corwin. The Augusta Chronicle. 1998-10-10: http://tinyurl.com/fo75n

MCG researchers indicted on 172 counts. Paul Garber. The Augusta Chronicle. 1997-02-12: http://web.archive.org/web/19970412062832/http://augustachronicle.com/stories/021997/met_borison.html

College a victim, chief says. Paul Garber. The Augusta Chronicle. 1996-02-19: http://web.archive.org/web/19970412062847/http://augustachronicle.com/stories/021997/met_borison2.html

MCG studies to get checkup. Paul Garber. The Augusta Chronicle. 1996-02-19: http://web.archive.org/web/19970412062923/augustachronicle.com/stories/021997/met_mcg_reax.html

FDA is reviewing researchers' work. Paul Garber. The Augusta Chronicle. 1996-10-18: http://web.archive.org/web/19970413235603/augustachronicle.com/headlines/101896/fda_review.html

MCG looking at changes admid reseach investigation. Paul Garber. The Augusta Chronicle. 1996-10-06: http://web.archive.org/web/19990503023151/www.augustachronicle.com/headlines/100696/research.html

Investigators asking if medical reseachers diverted funds. Paul Garber and Wayne Partridge. The Augusta Chronicle. 1996-08-17: http://web.archive.org/web/20000517184931/www.augustachronicle.com/headlines/081896/investigation.html

Ex-Profs Charged in Psych Department Research Scam. Michael Jonathan Grinfeld. Psychiatric Times. 1997;14(4): http://www.psychiatrictimes.com/p970401b.html

Form FDA 483 Issued to Kevin L. Keim Ph.D., Quintiles Pacific, Inc. 1999-01-13 [NDA 20-823 Novartis Exelon]: http://www.bioethicswatch.org/foia/quintiles483_19990113.pdf

El-Hage, A. Correspondence to Kevin L. Keim Ph.D., Quintiles Pacific, Inc. 1999-08-16 [NDA 20-823 Novartis Exelon]: http://www.circare.org/exelon/fda_quintiles_19990816.pdf

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Additional Resources

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Last Updated: 2012-07-27

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