Ethical Violations and Investigations Today
Ethical Violations / Investigations Today
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
May 7, 2002: Mount Sinai Medical Center NYC
April 28, 2003: Rehnquist Warns Drug Makers _Marketing Actimune for Unapproved Use_NYT
April 23, 2002: University of Chicago
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.
March 28, 2002: Mass. Mental Health Center (pdf file):
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.
Jan 24, 2002: Johns Hopkins University School of Medicine.
Jan 7, 2002. University of Colorado Health Science Center.
Dec 31, 2001:
Dec 20, 2001: University of Cincinnati. University Hospital.
1990 to Aug 2001:
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,
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.
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.
Overwhelming the Watchdogs. By Mary Pat Flaherty, Deborah Nelson and Joe Stephens.
The Dilemma: Submit or Suffer. By Sharon LaFraniere, Mary Pat Flaherty and Joe Stephens
Page A01 Third of six articles
An Isolated Region’s Genetic Mother Lode. Fourth of six articles.
By John Pomfret and Deborah Nelson
Thursday, December 21, 2000; Page A01 Fifth of six articles
Latin America Is Ripe For Trials, and Fraud By Karen DeYoung and Deborah Nelson
Feb 2, 2000: Congressional Testimony submitted by Vera Sharav:
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