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Ethical Violations / Investigations Today

Congressional Investigations

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


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