Author: Vera Sharav

AHRP Speaks Out

NIH Rule change Re: Whistle blowers – Comments due before June 15
April 19, 2004November 21, 2014

A request for comment about NIH proposed new research misconduct rule

See Fed Register:
http://ori.dhhs.gov/multimedia/acrobat/42CFRParts50and93.pdf

The new rule, I believe is meant to protect research institutions from the effective sting of a knowledgeable whistle blower.

The new rule would redefine whistle-blower as “complainant” and would limit the role of the complainant. Under the old rule, the whistle-blower participated in the process helping investigators by leading them to the evidence, etc.

Read More NIH Rule change Re: Whistle blowers – Comments due before June 15
Miscellaneous

Unlawful drug marketing: GlaxoSmithKline & 4,000 doctors Face Criminal Charges in Italy
March 25, 2004November 21, 2014

Unlawful drug marketing: GlaxoSmithKline & 4,000 doctors Face Criminal Charges in Italy Mon, 7 Jun 2004 On March 25, 2004, the US Attorney in Pennsylvania commenced an investigation of Eli Lilly’s marketing promotion of Zyprexa (olanzapine), Prozac (fluoxetine) and Evista (raloxifene). On April 19, a class action lawsuit was filed…

Read More Unlawful drug marketing: GlaxoSmithKline & 4,000 doctors Face Criminal Charges in Italy
Miscellaneous

Two Court Rulings Reject Pfizer-FDA Preemption Claim in Zoloft "failure to warn" cases
March 22, 2004November 21, 2014

Two Court Rulings Reject Pfizer-FDA Preemption Claim in Zoloft “failure to warn” cases Thu, 21 Jul 2005 In a stunning federal court order JAMES M. ROSENBAUM, US Chief District Judge in Minnesota, overturned FDA-supported pre-emption arguments in their entirety! “The FDA has no authority to declare, ipse dixit, that a…

Read More Two Court Rulings Reject Pfizer-FDA Preemption Claim in Zoloft "failure to warn" cases
Miscellaneous

Sen Domenici Blasts NIH doctors calling them "pigs" – The Hill
March 17, 2004November 21, 2014

Sen Domenici Blasts NIH doctors calling them “pigs” – The Hill Thu, 18 Mar 2004 The shameful revelations of insatiable greed among medical researchers at the National Institutes of Health has disgusted Sen. Pete Domenici, one of the strongest supporters of medical research. “I hate to say it, but the…

Read More Sen Domenici Blasts NIH doctors calling them "pigs" – The Hill
Children Victimized | Foster Care

BBC 2: Guinea Pig Kids: Vulnerable NYC foster children forced to test AIDS drugs
March 10, 2004September 9, 2016

Tue, 30 Nov 2004 Tonight the BBC- 2 is airing an investigative report about a series of drug experiments that were conducted on infants and children who were under the guardianship of the New York City Agency for Children’s Services (ACS), and living at Incarnation Children’s Center, a foster care…

Read More BBC 2: Guinea Pig Kids: Vulnerable NYC foster children forced to test AIDS drugs
AHRP Speaks Out | Children Victimized | Foster Care | Immoral Experiments

Complaint: Phase I AIDS Drug/Vaccine Experiment on Foster Children
March 10, 2004March 27, 2016

ALLIANCE FOR HUMAN RESEARCH PROTECTION Homepage 142 West End Ave. Suite 28P New York, NY 10023 March 10, 2004 Dr. Michael Carome Chief of Compliance Office of Human Research Protections David Horowitz Director, Office of Compliance Food & Drug Administration Dept. of Health and Human Services cc: Dr. Bernard Schwetz,…

Read More Complaint: Phase I AIDS Drug/Vaccine Experiment on Foster Children
AHRP Speaks Out

AHRP Calls for Federal Investigation of Drug Trials Using Children in Foster Care
March 10, 2004November 21, 2014

RE: Phase I Drug trials used foster children in violation of 45 CFR 46.409 and 21 CFR 50.56

The Alliance for Human Research Protection (AHRP) has reason to believe that federal regulations for the protection of children as research subjects have been seriously violated in federally funded HIV research.

We have learned that a series of Phase I and Phase II drug experiments were conducted on infants and children who were under the guardianship of the New York City Agency for Children’s Services (ACS), and living at Incarnation Children’s Center, a foster care facility under contract with ACS.

Read More AHRP Calls for Federal Investigation of Drug Trials Using Children in Foster Care
Miscellaneous

Ethics Policy Announced for NIH Officials – LAT
March 2, 2004November 21, 2014

Ethics Policy Announced for NIH Officials – LAT Tue, 2 Mar 2004 This is a case demonstrating the power of the press ( the “fourth estate”) in its most important role providing a check on the abuse of government power. An investigative report by David Willman, Pulitzer Prize winning journalist…

Read More Ethics Policy Announced for NIH Officials – LAT
Miscellaneous

TeenScreen – Angel of Mercy or Pill-Pusher for Drug Industry
March 2, 2004November 21, 2014

TeenScreen – Angel of Mercy or Pill-Pusher for Drug Industry Thu, 14 Apr 2005 An investigative reporter has dug up the facts behind TeenScreen, the aggressive marketing scheme that targets America’s school children who are being “screened” for undetected mental problems – even though no accurate diagnostic screening tool for…

Read More TeenScreen – Angel of Mercy or Pill-Pusher for Drug Industry
Miscellaneous

Comprehensive Children’s Mental Health Systems
March 1, 2004

KAREN VAN LANDEGHEM: E7 – Comprehensive Children’s Mental Health Systems (GEN) – March 1, 2004 http://128.248.232.90/archives/mchb/amchp2004/e7/transcripts/session19b.htm KAREN VAN LANDEGHEM: Good afternoon. I want to thank AMCHP for inviting Illinois to be here and I, I need to say that, actually Barbara Shaw who’s the chair of the Illinois Children’s Mental…

Read More Comprehensive Children’s Mental Health Systems
Miscellaneous

HIV Foster Babies, Children Used to test safety of Experimental Drugs – NY Post
February 29, 2004November 21, 2014

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…

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

20% volunteers drop out after suicide in Eli Lilly’s duloxetine trial
February 12, 2004November 21, 2014

20% volunteers drop out after suicide in Eli Lilly’s duloxetine trial Thu, 12 Feb 2004 The Associated Press reports that nearly a fifth of the volunteers testing Eli Lilly’s antidepressant drug, duloxetine, dropped out after Traci Johnson, a 19-year old student committed suicide at a company laboratory. “Three participants in…

Read More 20% volunteers drop out after suicide in Eli Lilly’s duloxetine trial