Chief Respiratory Care Mass General Hospital-Harvard-Rejects ARDS Recommendation

A critical editorial by Dr. Robert M Kacmarek, Head of Respiratory Care Services at Massachusetts General Hospital and professor at Harvard University—the coordinating center for the ARDS Network, calls into question the validity of the ARDS Network recommendation of treating all patients with ALI-ARDS with a fixed, low air ventilation setting (6 mL/ kg).

 

Gov Accountability Project Creates "FactSquad" on Rx Drugs

Gov Accountability Project Creates “FactSquad” on Rx Drugs December 11, 2005 In the wake of the credibility crisis public trust in the safety of FDA-approved prescription drugs is eroded. The Government Accounability Project (GAP) has established a “Fact Squad” to challenge poor performance; in particular,  FDA’s failure to protect the…

Russian Roulette Medicine: More kids get multiple psychiatric drugs

Russian Roulette Medicine: More kids get multiple psychiatric drugs Wed, 3 Aug 2005 Stop the madness! Child psychiatrist, Joseph Penn, advises: “Parents shouldn’t passively accept whatever doctors recommend for children with behavior or psychiatric problems.” “We just don’t have the efficacy or safety data to back up what is common…

Pfizer Zoloft Warnings to Canadian Doctors Contrast to US – FDA Caves In to Lobbying

Pfizer Zoloft Warnings to Canadian Doctors Contrast to US – FDA Caves In to Pharma lobbying Thu, 10 Feb 2005 The FDA has, once again, quietly colluded with industry, compromising the safety of children’s lives to maintain drug manufacturers’ cash flow. After two FDA advisory committee hearings (Feb 2-3 and…

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…

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

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…

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AHRP Testimonies re: Fatal ARDS Lung Experiment

On June 10, 2003, a panel of experts convened by the federal Office of Human Research Protections (OHRP) heard presentations by critics who had filed complaints about $37 million government sponsored, multi-site experiment conducted by major academic institutions participating in the ARDSNetwork, and by the ARDSNet investigators who defend the trial.

The experiment tested two extreme, rarely used methods of mechanical lung ventilation in 861 critically ill, vulnerable patients suffering from acute lung disease (ALD) or acute respiratory distress syndrome (ARDS).

References: Impact of FDA inclusion of children as test subjects

References for THE IMPACT OF THE FDA MODERNIZATION ACT ON THE RECRUITMENT OF CHILDREN FOR RESEARCH Vera Hassner Sharav Published in ETHICAL HUMAN SCIENCES & SERVICES Summer 2003, vol. 5 pp. 83-108 Agency for Health Care Research & Quality. (1999). Treatment of attention-deficit/hyperactivity disorder: Summary, evidence Report / Technology assessment…

Dissenting Opinion – Proposed Children’s Workgroup Reinterpretation of Fed Regs 45 CFR 46 sects. 404 & 406

Dissenting Opinion (NHRPAC Children Workgroup) re: Proposed Reinterpretation of Fed. Regs Protecting Children (45 CFR 46, sections 404 and 406) May 14, 2002 To: Alan Fleischman, MD, Chair, Children’s Workgroup of NARPAC        Mary Faith Marshall, Ph.D., Chair, NARPAC From: Vera Hassner Sharav Re: Dissenting Opinion re: Report to NHRPAC, proposing…