Vioxx Fallout: Merck Officials Intervened–NYT / FDA Officials Intervened–Mother Jones

Vioxx Fallout: Merck Officials Intervened–NYT / FDA Officials Intervened–Mother Jones Mon, 25 Apr 2005 Mother Jones and The New York Times focus on the Vioxx fall out–a case that encapsulates the corrupt practices in drug research. Merck and FDA officials intervened to conceal the lethal cardiac effect of Vioxx. Mother…

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

THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) www.ahrp.org Proposed Changes to Subpart D Regulations Increase Risks to Children in Non-Therapeutic Research Statement of the AHRP Opposing the SACHRP Children’s Committee Recommendations April 18, 2005 The Alliance for Human Research Protection (AHRP) welcomes the opportunity to respond to the question “What…

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.

US Marshals Seize Millions of Defective Paxil & Avandamet pills – NYT

US Marshals Seize Millions of Defective Paxil & Avandamet pills_NYT Mon, 7 Mar 2005 The FDA and federal marshals yanked millions of tablets of the antidepressant, Paxil CR (Seroxat, controlled release) and the diabetes drug, Avandamet, off the market because they are defective. The Paxil pills split during manufacturing, and…

Children’s Mental Health in the 108th Congress: The Good, The Bad, and The Ugly

Children’s Mental Health in the 108th Congress: The Good, The Bad, and The Ugly Wed, 15 Dec 2004 AHRP board member, Dr. Karen Effrem, provides a succinct overview of actions – the good, the bad, and the ugly–taken by the 108th Congress will have an impact on children’s health and…

Texas Foster Care Investigation – Children as young as 3 are drugged with antipsychotics

Texas Foster Care Investigation – Children as young as 3 are drugged with antipsychotics Sat, 13 Nov 2004 The Dallas Morning News reports that Texas comptroller, Carole Keeton Strayhorn, who hade conducted an investigation of the foster care system, concluded that up to $4 million a year might be wasted…

FDA Failed to Enforce Law Requiring Drugmakers to Disclose Test Data – WashPost

FDA Failed to Enforce Law Requiring Drugmakers to Disclose Test Data – WashPost Tue, 6 Jul 2004 A front page article in The Washington Post reports that the FDA failed to enforce the law that requires drug companies to disclose ALL clinical drug trials and ALL trial findings-whether they’re good…

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

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…

NAMI & Eli Lilly partners in bankrupting state Medicaid budgets – NYT

NAMI & Eli Lilly partners in bankrupting state Medicaid budgets – NYT Sat, 20 Dec 2003 The New York Times reports that Medicaid expenditure for prescription drugs has escalated to $27.5 billion. These costs are up 19% from last year. Antipsychotic drugs, such as Eli Lilly’s Zyprexa, eat up more…