Office of Human Research Protections
(OHRP) Letters of Determination:
http://ohrp.osophs.dhhs.gov/detrm_letrs/lindex.htm
Office of Protection from Research Risks* (OPRR) List
of Compliance Oversight
Investigations Resulting in Restrictions or Actions to federally licensed
Institutions between 1990 - 2000.
*Reorganized in 2000 as OHRP
Mar 30: AHRP Ethical and Scientific Objections to FDA's Proposed Licensure of Anthrax Vaccine
Oct 4: Op Ed: Psychiatry on the Ropes--WP / Evidence-based Psychiatry
Oct 3: BBC PANORAMA TONIGHT - Taken on Trust - 13 years-Medical Deception
Aug 26: David Healy's response (502K pdf file) to a slanderous personal attack by Pfizer, posted by the FDA on FDA's website, August 20
Aug 12: US Research Community May Take Lessons in Medical Ethics from Cambodian Prostitutes
Aug 6: Psychiatrist Scolds the APA After Winning Distinguished Fellow Award/ NYC Sues 44 Pharma Companies
Aug 4: FDA Approves Lilly's Cymbalta for Depression Despite Risk of Suicide
Aug 3: Drug safety Hearings-Sept-Congress/ FDA - Lilly Plans to Disclose Data
Jul 27: Fast growing business: Unethical clinical trials in India - Asia Times
Jul 26: Pfizer Lawsuits: Zoloft / Neurontin Concealed Evidence: Suicide Risk/ Lack of Efficacy
July 7, 2004: Pharma Influence: Penn Psychiatrist Files Whistleblower Lawsuit - Investigtion Confirms Medicare Chief Lied to Congress
Jun 27, 04: NIH Under Fire: Longtime Favorite of Congress - Wash Post / WSJ
Jun 26: Forest Labs Admits Concealment of data - Congressional Probe Expands
Jun 20: HMO physician applauds Spitzer's focus on information bias / NYT blind spot
Jun 12: Bad Medicine - Editorial - Guardian UK
June 8: Glaxo chief executive angry over NYS AG lawsuit - Telegraph
June 7: Unlawful drug marketing: GlaxoSmithKline & 4,000 doctors Face Criminal Charges in Italy
Jun 5: "Black Hole" of medical research--Negative Results Don't get Published - JAMA, WSJ
Jun 3: Spitzer's Lawsuit Will Shake Up the Drug Industry - Full Disclosure is the Goal
May 18, 2004: Lawmakers accused leaders of the NIH of encouraging "the option of corruption."
Jan 19, 2004: Critics of NIH Studies Prompt Senate Hearing - WashPost
Jan 15, 2004: NIH ethics review
Jan 9, 2004: Zolft pediatric study in JAMA challenged by peers - JAMA letters
Dec 19, 2003: Not-So-Public-Relations: Drug Industry & Bioethics - is it casuistry or sophistry?
Dec 13, 2003: Chief of VA Research Departs amidst allegations of misconduct, financial indiscretion - BNA
Dec 5, 2003: Researchers Caught Faking AIDS data in NIH funded research
Dec 2, 2003: Integrity of Scientific Findings Marred
Nov 19, 2003: Survivor of Nazi Sterilization Experiments Says $8,000 Isn't Enough
Nov 14, 2003: Frontline: Dangerous Prescription
Nov 11, 2003: Medication switched for research purposes - patient nearly dies
Nov 8, 2003: Chromium 6_Carcinogen tested in 5 humans in the US
Nov 5, 2003: Debate: Ethics of Surgically Implanting Drug Device in Psychiatric Patients
Nov 5, 2003: FDA Advisor: "Ignore breast implant vote"
Oct 25, 2003: Why did OHRP SHRED informed consent documents?
Oct 17, 2003: Is it Cloning? U.S. experiment in China - Baltimore Sun
Oct 17, 2003: Nazi euthanasia files are made public - BMJ
Oct 14, 2003: Appeals Court reinstates Nigerian research case against Pfizer
Oct 14, 2003: WSJ: Court Revives Suit Against Pfizer On Nigeria Study
Oct 7, 2003: OHRP Letter to ARDSNetwork re: Investigation of Acute Respiratory Distress Syndrome
Oct 7, 2003: Ethics of U Penn surgical "drug implant" experiment
Oct 1, 2003: China Daily update: Harvard genetic research in rural China
Sept 29, 2003: Doctor's Misconduct Left Trail of Broken Lives--A Broken Marriage and a 'Life Destroyed' - WashPost
Sept 25, 2003: China Daily investigation challenges US genetic experiments on poor farmers
Aug 19, 2003: Gene Therapy Experiment Called "Crazy"
Aug 6, 2003: A Come Back for Psychosurgery?
July 11, 2003: AHRP Letter to Editor re: ARDS published NEJM
July 11, 2003: Iowa seeks dismissal of lawsuit: Monster Experiment induced stuttering
July 8, 2003: Congressional Investigation of NIH: Cash Gifts From Grantees
July 7, 2003: OHRP Found NHLBI Lung Experiments Violated Informed Consent
July 1, 2003: AHRP Response to criticism re: fatal ARDS lung experiment
June 10, 2003: AHRP Testimonies re: Fatal ARDS lung experiment
June 4, 2003: Auditing Standards in Accounting and Medicine
May 22, 2003: Bayer Documents: AIDS Tainted Blood Killed Thousands of Hemophiliacs
May 19, 2003: Research dispute prompts patient-trials debate_Seattle Times
April 30, 2003: Artificial Heart experiment without informed consent?
April 10, 2003: Letter Submitted to New England Journal of Medicine re ARDS Investigation
April 13, 2003: Research at US Veterans Hospitals Nationwide Under Investigation_NYT
March 10, 2004: AHRP Calls for Federal Investigation of Drug Trials Using Children in Foster Care in Violation of Federal Regulations
March 9, 2003: Medical Confidentiality of Research Subject in Jeopardy--Lawyers Subpoena Anthropologist
February 2003: Remember Saddam's human guinea pigs by Jonathan Moreno, (Center for Biomedical Ethics, University of Virginia) in The American Journal of Bioethics 3(2): InFocus. http://bioethics.net/in_focus/moreno.pdf
February 9, 2003: UK Patients Used as Drug 'Guinea Pigs"_Guardian
February 6, 2003: VA Drug Study Deaths under Criminal Investigation in NY_BNA
January 8, 2003: "Should the EPA Accept Human Pesticide Experiments?", testimony by Vera Hassner Sharav before the Committee on the Use of Third Party Toxicity Research with Human Research Participants; Science, Technology, and Law Program; The National Academies of Science
December 24, 2002: Moral turpitude: Herpes experiment surpasses Tuskegee
December 16, 2002: Former President of Amer Heart Assoc Caught in Fraud
December 10, 2002: Patient vs. Portfolio: ImClone_Salon
October 8, 2002: Last Journey of Artificial Heart Recipient - NYT
September 27, 2002: Is This Permissible Medical Research?
September 25, 2002: NIH suspended ARDS Lung experiment in Aug / AHRP filed complaint re: ARDS in July
September 9,
2002: Human
Pesticide Experiment: The Slippery Slope - Sunday Herald
Note: more info. available on AHRP's human pesticide
experiments page.
September 4, 2002: AHRP Replies to OHRP Response re Surrogate Consent (ARDS Study).
August, 2002: Special Report: Experiments on Humans, San Francisco Chronicle
August 28,
2002: OHRP
Response to AHRP re: Surrogate Consent (ARDS Study).
Federal
Investigation of ARDS Study
August 28, 2002: "A Metaanalysis of ALI and ARDS Trials Testing Low Tidal Volumes." Eichacker, et al, American Journal of Respiratory and Critical Care Medicine (a critique of the ARDS Study).
July 29, 2002: University of California, San Francisco: Patients Rights Violated
July 29, 2002: AHRP Letter of complaint to Dr. Greg Koski, OHRP. Re: ethical violations in multi-center respiratory distress experiment. (ARDS Study).
July 26, 2002: Stop California AB 2328 (unauthorized consent to research)
July 25, 2002: AHRP Questions Ethics of ARDS Study
May 15, 2002:
Harvard's president admits Chinese experiments were " wrong"
AHRP Infomail, May 15 2002
May 13,
2002: Children's Hospital Pittsburgh
http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/may02e.pdf
May 7,
2002: Mount Sinai Medical Center NYC
http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/may02a.pdf
April 28, 2003: Rehnquist Warns Drug Makers _Marketing Actimune for Unapproved Use_NYT
April
23, 2002: University of Chicago
http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/apr02u.pdf
April 16, 2002: University of California Los Angeles. Moratorium on IRB Approval of Surrogate or Proxy Informed Consent for Human Subjects Research http://www.oprs.ucla.edu/human/NewsLetters/041602.htm
April
4, 2002: Cornell Medical Center NYC.
http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/apr02u.pdf
March 28, 2002:
Mass. Mental Health Center (pdf file):
http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/mar02c.pdf
March 28, 2002:
Brigham & Women's Hospital (pdf file):
http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/mar02a.pdf
March 28, 2002:
Harvard University School of Public Health (pdf file):
http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/mar02b.pdf
Feb. 8, 2002: Federal investigation finding: informed consent requirements viotated. University of California, San Francisco. http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/feb02l.pdf
Feb 4,
2002: University of Maryland School of Medicine.
http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/feb02f.pdf
Jan 24,
2002: Johns Hopkins University School of Medicine.
http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/jan02j.pdf
Jan 7,
2002. University of Colorado Health Science Center.
http://ohrp.osophs.dhhs.gov/detrm_letrs/YR02/jan02b.pdf
Dec 31, 2001:
FDA WARNING LETTER to Dana Matthews, M.D.
Frederick Hutchinson
Cancer Center (pdf file):
http://www.fda.gov/foi/warning_letters/g2083d.pdf
Dec 20,
2001: University of Cincinnati. University Hospital.
http://ohrp.osophs.dhhs.gov/detrm_letrs/dec01h.pdf
1990 to Aug 2001: Government Investigations
July 21, 2001: Government Agency Caves in to Johns Hopkins pressure
July 19 2001: OHRP suspends Johns Hopkins Research license for Fed funded research
July 17, 2001: Johns Hopkins Admits Fault in Fatal Experiment
March 11, 2001:
Seattle Times Series,
"Investigation of Fred Hutchinson Cancer
Center"
February 19, 2001: Research Compliance Note. Thomas Dalglish, JD, PhD Analysis of 94 OHRP letters of determination, July 1, 2000 to July 15, 2001.
Feb 15,
2001: Philadelphia Veterans Affairs Medical Center.
http://ohrp.osophs.dhhs.gov/detrm_letrs/feb01e.pdf
Dec 17-21, 2000. THE WASHINGTON POST. The Body Hunters. Six part investigative series.
As Drug Testing Spreads, Profits and Lives Hang in Balance. First of six articles By Joe Stephens. http://www.washingtonpost.com/ac2/wp-dyn/A11939-2000Dec15?language=printer
Overwhelming the Watchdogs. By Mary Pat Flaherty, Deborah Nelson and Joe Stephens. http://www.washingtonpost.com/ac2/wp-dyn/A11976-2000Dec15?language=printer
The
Dilemma: Submit or Suffer. By Sharon LaFraniere, Mary Pat Flaherty
and Joe Stephens
Page A01 Third of six
articles
http://washingtonpost.com/wp-dyn/articles/A22893-2000Dec18.html
An
Isolated Region's Genetic Mother Lode. Fourth of six articles.
By John Pomfret and
Deborah Nelson
http://www.washingtonpost.com/wp-dyn/articles/A26797-2000Dec19.html
Thursday, December 21, 2000;
Page A01 Fifth of six articles
Latin America Is Ripe For Trials, and Fraud By Karen DeYoung and
Deborah Nelson
http://www.washingtonpost.com/ac2/wp-dyn/A31027-2000Dec20?language=printer
Feb 2, 2000:
Congressional Testimony submitted by Vera Sharav:
"Chemically Induced
Psychosis Experiments: An Inhumane Paradigm in Psychiatric Research"
November 15 - 18, 1998: The Boston Globe. Doing Harm: Research on the Mentally Ill. Four part investigative series.
Testing Takes Human Toll by Robert Whitaker and Dolores Kong. http://www.boston.com/globe/nation/packages/doing_harm/day1.htm
Debatable Forms of Consent by Dolores Kong. http://www.boston.com/globe/nation/packages/doing_harm/day2.htm
Lure of Riches Fuels Testing by Robert Whitaker. http://www.boston.com/globe/nation/packages/doing_harm/day3.htm
Still No Solution in the Struggle on Safeguards by Dolores Kong. http://www.boston.com/globe/nation/packages/doing_harm/
November 18, 1998: Panel Urges Review of Patient Studies by Dolores Kong. http://www.boston.com/globe/nation/packages/doing_harm/review111898.htm