Category Archives: Human Experimentation

Fatal Drug Error Kept From Family – Nevirapine

Associated Press
Dec. 16, 2004 | by Chris Hawke

Never Told That Experimental AIDS Drugs Likely Killed Woman

image661481x
A family photograph of Joyce Hafford, who died in 2003 in an experimental drug regimen. (AP /APTN)

(AP) A pregnant Tennessee woman who enrolled in federally funded research in hopes of saving her soon-to-be-born son from getting AIDS died last year when doctors continued to give her an experimental drug regimen despite signs of liver failure, government memos say.

Family members of Joyce Ann Hafford say the 33-year-old HIV-positive woman died without ever holding her newborn boy. They also said they never were told the National Institutes of Health concluded the drug therapy likely caused her death. Continue reading Fatal Drug Error Kept From Family – Nevirapine

The ICC Investigation – Deaths in Studies with NYC Orphans – AHRP on the VERA Institute Report

ALLIANCE FOR HUMAN RESEARCH PROTECTION
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org and http://ahrp.blogspot.com

The final report of the VERA Institute investigation commissioned in 2005 by the NYC Administration of Child Services will hardly put to rest the controversy surrounding a 20-year period during which children in foster care were subjected to toxic Phase I and Phase II AIDS drug and vaccine experiments–mostly without parental consent and without the protection of an independent advocate–as mandated by federal regulations in force then and now.
Continue reading The ICC Investigation – Deaths in Studies with NYC Orphans – AHRP on the VERA Institute Report

The ICC Investigation – Radio Interview with Liam Scheff, and ICC childcare worker Mimi Pascual on the Lizz Brown Show

The following transcript is taken from the 2005 radio interview on the Lizz Brown Show (lizzbrown.com), featuring Mimi Pascual, former ICC orphanage childcare worker and Liam Scheff, who broke and investigated the story. Mimi worked at ICC for 8 years over a ten year period. Her story is told in “Inside Incarnation” [Here]

Listen to the interview Continue reading The ICC Investigation – Radio Interview with Liam Scheff, and ICC childcare worker Mimi Pascual on the Lizz Brown Show

Still on Trial

April 2005. NY Press

Last July, New York Press published “Orphans on Trial,” the story of the HIV-positive children of Incarnation Children’s Center (a Washington Heights Catholic orphanage overseen by Columbia Presbyterian Medical Center). The piece detailed how these children are being used in National Institutes for Health- and pharmaceutical-industry-sponsored clinical trials. Continue reading Still on Trial

The Good Man at the NIH

GNN, January 2006

Mr. Fishbein Goes to Washington

Dr. Jonathan Fishbein’s fight for medical ethics in AIDS medicine

Editor’s note: In December 2005, GNN’s Liam Scheff spoke with NIH whistleblower Dr. Jonathan Fishbein. In an exclusive interview, Fishbein discusses the controversial African AIDS drug trials he exposed, his firing and reinstatement and how medical ethics and the public trust are violated when profit and politics rule the day. – A.L.
Continue reading The Good Man at the NIH

The NIH Scandal and the Future of AIDS Research

GNN June 2005

A federal investigation calls drug trials on orphans unethical. Now what?

ICC) has found that the National Institute of Health (NIH) and Columbia Presbyterian Hospital acted unethically.

The Associated Press reported Thursday June 16th: “The government has concluded at least some AIDS drug experiments involving foster children violated federal rules designed to ensure vulnerable youths were protected from the risks of medical research.” Continue reading The NIH Scandal and the Future of AIDS Research

Dr. Jonathan Fishbein, NIH-Whistleblower on Nevirapine, Reinstated with Honors

by Liam Scheff

Dr. Jonathan Fishbein, former NIH AIDS doc and good apple who was fired after he threatened the worldwide sale of the dangerous AIDS drug Nevirapine by reporting ethical misconduct during the course of the Ugandan drug trial, has been reinstated to government service, with praise. Continue reading Dr. Jonathan Fishbein, NIH-Whistleblower on Nevirapine, Reinstated with Honors

False Positive HIV Tests in Pregnant Women

Tests that test for pregnancy…also used to test for a “specific” virus?

From the review:

“A strongly reactive ELISA result is more likely to indicate that the person is infected (true-positive result) than a weakly reactive result.16-17

  • There are many ‘levels’ of reaction, but no standard as to what constitutes a true versus a false positive.

The ELISA screening test is inexpensive and is designed with a low threshold so that few infected individuals will be missed. However, like other screening tests, it will also capture some uninfected individuals.

More Guinea Pig Kids

An ongoing investigation by the Vera Institute of Justice, has uncovered 59 additional New York City foster care children–between July and September–who may have been used in AIDS drug / vaccine trials in violation of federal regulations. This brings the tentative total number of mostly minority children involved, to 773.

These children were enrolled in the risky experimental trials in violation of federal regulations. They were used as experimental subjects without legal informed consent and without an independent advocate authorized to serve the children’s best interest. The Vera Institute investigation is charged with finding out not only how many children were involved in the experiments and to ascertain what happened to those children.

The investigation by the Vera Institute follows an investigation by the federal Office of Human Research Protections which was initiated by a complaint filed by The Alliance for Human Research Protection March 10, 2004: [Link]

The investigation, however, is being hampered by administrators of Columbia Presbyterian hospital, which had a major involvement in the experimental drug and vaccine trials. Despite repeated requests by the Vera Institute, Columbia administrators have thus far refused to provide access to the medical records of the foster care children who were enrolled in the trials. This is a demonstration of abuse of power by medical institutions that hugely benefit from taxpayer support.
In February, 2006, OHRP found Columbia University Medical Center (CUMC) New York /Presbyterian Hospital in non-compliance with federal research protection regulations. See OHRP letter at: [Link] Continue reading More Guinea Pig Kids

HIV Foster Babies, Children Used to test safety of Experimental Drugs – NY Post

HIV Foster Babies, Children Used to test safety of Experimental Drugs – NY Post

Sun, 29 Feb 2004

As a society, we need to be concerned that too many within the medical research community seem to have abandoned the foremost principle of medical ethics: First, do no harm.

The latest evidence of medical research gone awry was uncovered by The New York Post (below). It involves foster care children diagnosed with HIV. “The most vulnerable, disadvantaged children are being exploited by powerful entities and used as guinea pigs as if they were not human beings.”
Continue reading HIV Foster Babies, Children Used to test safety of Experimental Drugs – NY Post

Aids Tots Used as Guinea Pigs

SHOCKING EXPERIMENTS

AIDS TOTS USED AS ‘GUINEA PIGS’
By Douglas Montero

NY Post

“I took the girls out of hell—and the city stole them back”
February 28, 2004

Jacqueline Hoerger will never forget the raid of her Nyack home by foster-care social workers who snatched the two HIV-positive sisters she was trying to adopt.

Her crime: She was accused of neglect by the girls’ doctor of because she refused to give them a potentially dangerous cocktail of high-powered AIDS medications that she felt made them sicker.
Continue reading Aids Tots Used as Guinea Pigs

Nevirapine – FDA Summary of Drug alerts -1999

BOXED WARNING:

“SEVERE AND LIFE-THREATENING SKIN REACTIONS (STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS), INCLUDING FATAL CASES, HAVE OCCURRED IN PATIENTS TREATED WITH VIRAMUNE” Deleted –
Replaced with the following text –

“SEVERE, LIFE-THREATENING SKIN REACTIONS, INCLUDING FATAL CASES, HAVE OCCURRED IN PATIENTS TREATED WITH VIRAMUNE. THESE HAVE INCLUDED CASES OF STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, AND HYPERSENSITIVITY REACTIONS CHARACTERIZED BY RASH, CONSTITUTIONAL FINDINGS, AND ORGAN DYSFUNCTION. PATIENTS DEVELOPING SIGNS OR SYMPTOMS OF SEVERE SKIN REACTIONS OR HYPERSENSITIVITY REACTIONS MUST DISCONTINUE VIRAMUNE AS SOON AS POSSIBLE. (see WARNINGS)”

Continue reading Nevirapine – FDA Summary of Drug alerts -1999

Over a quarter of HIV-positive children on treatment have lipodystrophy in European study – 2004 aidsmap.com

AIDS drugs cause body-fat distribution, increased cholesterol, elevated triglyerides (increased risk of heart disease)

”*Our results demonstrate that lipodystrophy among HIV-infected children in Europe is already a significant issue, despite the fact that HAART has only been widely used for the past five years*”, comment the investigators. They also warn “the problem may worsen with time” as they found an association between lipodystrophy and increasing age and longer duration of HAART.

also of note – related article list at the bottom highlights the discordance between Actual health – and surrogate markers.

http://www.aidsmap.com/en/news/1AC40E4E-C348-49A5-A429-24EF788E9293.asp Continue reading Over a quarter of HIV-positive children on treatment have lipodystrophy in European study – 2004 aidsmap.com