October 26

Ethical Violations and Investigations Today

Ethical Violations / Investigations Today

Congressional Investigations

Office of Human Research Protections (OHRP) Letters of Determination:

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):

March 28, 2002: Harvard University School of Public Health (pdf file):

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: FDA WARNING LETTER to Dana Matthews, M.D.
Frederick Hutchinson Cancer Center (pdf file):

Dec 20, 2001: University of Cincinnati. University Hospital.

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.

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

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:
"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

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