Statement of the AHRP Opposing the SACHRP Children’s Committee Recommendations

The Alliance for Human Research Protection (AHRP) welcomes the opportunity to respond to the question “What is the Best Way to Protect Children?”

Our recommendation – which is backed up by evidence that children have suffered harm in medical research – is to significantly limit the discretion of IRBs to approve greater than minimal risk research without direct benefit for the child-subjects under 46.406.

We recommend staying the course in requiring that any such proposed experiment undergo a transparent open evaluation with ample opportunity for public oversight and comment – as required under the provisions of 46.407.

Depressing news for GSK

Depressing news for GSK Thu, 14 Apr 2005 A class lawsuit by US investors has been filed against GlaxoSmithKline in the US federal District Court in New York, alleging violation of securities laws. The suit charges GSK issued “false or misleading public statements” about the antidepressant, Paxil (Seroxat). The law…

NY Times Public Advocate: Extra! Extra! Read Not Quite Everything About It!

NY Times Public Advocate: Extra! Extra! Read Not Quite Everything About It! Sun, 10 Apr 2005 The New York Times Public Editor pointed the finger at the Times for its unprofessional journalistic lapses–such as prematurely publishing scoops planted by one of the parties to a dispute. The issue involved complaints…

Acting EPA Chief Withdraws Controversial Pesticide Experiment – LAT / NYT

Acting EPA Chief Withdraws Controversial Pesticide Experiment – LAT / NYT Sat, 09 Apr 2005 “We are gratified that when this abominable experiment was exposed to the public, the pesticide industry and its EPA advocates had to surrender." Senator Barbara Boxer has expressed her concern “over the larger philosophy behind…

UK Parliament Report Re: Pharma Influence / US Regulators Comatose as 258 Fatal Suicides Linked to Neurontin

UK Parliament Report Re: Pharma Influence / US RegulatorsComatose as 258 Fatal Suicides Linked to Neurontin Wed, 6 Apr 2005 The Health Committee of the British House of Commons, has just released its report, “The Influence of the Pharmaceutical Industry.” This landmark document is not just of value to UK…

EPA Nominee Challenged in Senate Over Children’s Pesticide Experiment

EPA Nominee Challenged in Senate Over Children’s Pesticide Experiment Thu, 07 Apr 2005 AHRP applauds Senator Barbara Boxer for pledging to hold up the confirmation of Stephen Johnson, the President’s nominee to head the Environmental Protection Agency, until he pulls the plug on “the appalling, unethical, and immoral” children’s pesticide…

Article

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting Openness, Full Disclosure, and Accountability www.ahrp.org Statement by Vera Hassner Sharav Founder & President, AHRP April 1, 2005 Anthrax Band Reunion Press Conference New York City My name is Vera Hassner Sharav, and I am president of The Alliance for Human Research Protection:…

Statement by Vera Hassner Sharav, Anthrax Band Reunion Press Conference

My name is Vera Hassner Sharav, and I am president of The Alliance for Human Research Protection: a national human rights organization that exposes unethical research practices which undermine the dignity, rights, and safety of human subjects.

In 1947, an American military tribunal sat in judgment of the Nazi doctors at Nuremberg, and laid down ten essential principles that define “permissible medical experiments” in a civilized society. Those principles are enshrined in the Nuremberg Code which is the cornerstone of all medical research ethics. The nations of the world adopted the Code as a safeguard to prevent future medical atrocities.

Two Federal Courts Reject Pfizer’s Federal Preemption Argument in cases involving Zoloft

Two Federal Courts Reject Pfizer’s Federal Preemption Argument in cases involving Zoloft Fri, 01 Apr 2005 With assistance from Daniel Troy as chief counsel of the FDA, Pfizer argued that state courts have no right to decide that a drug manufacturer can be held liable for not disclosing severe –…

AHRP Ethical and Scientific Objections to FDA’s Proposed Licensure of Anthrax Vaccine

When a federal judge ruled the vaccine to be an "investigational drug and a drug being used for an unapproved purpose" on December 22, 2003, FDA hurriedly issued a Final Rule for anthrax vaccine. The agency submitted its Final Rule just eight days after a federal court injunction, having failed to do so for 19 years. In a January 7, 2004 court hearing the same judge called FDA’s actions "highly suspicious." On October 27, 2004 FDA’s arbitrary and capricious promulgation of this Final Rule resulted in a permanent injunction, remanding the license to your agency to complete according to the law. The injunction also halted what the judge called DoD’s "illegal" mandatory anthrax vaccination program.

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Dying to be Famous? Shooting Fuels Debate Over Safety of Prozac for Teens

Dying to be Famous? Shooting Fuels Debate Over Safety of Prozac for Teens Sun, 27 Mar 2005 An Op Ed in The New York Times by Lionel Shriver (from London), dismisses the notion promulgated by the mental health industry–which is under the influence of drug companies–that “early signs” in troubled…