Best Pharmaceuticals for Children Act of 2002


Comments submitted by The Alliance for Human Research Protection
to The National Academy of Sciences
Committee of the Institute of Medicine on Clinical Research Involving Children

AHRP has been closely monitoring pediatric research trends since passage of the FDA Modernization Act of 1997. We believe that medications used in children should be thoroughly tested for safety, effectiveness and appropriate dose. But unlike adults who can exercise their autonomous right to informed consent, children who are enrolled in clinical trials are non-consensual human subjects. They should not, therefore, be made to assume the burden of testing possibly toxic drugs whose safety is unknown.

Debate Resumes on the Safety of Depression’s Wonder Drugs – NYT

Debate Resumes on the Safety of Depression’s Wonder Drugs – NYT Thu, 7 Aug 2003 After a decade of lies, deception, and cover-up of evidence linking antidepression drugs – such as, Prozac, Paxil, Zoloft – to acts of suicide in previously non-suicidal people – children and adults, some of who…

Brainstorm to Breakthrough: A Surgical Procedure is Born – NYT

Brainstorm to Breakthrough: A Surgical Procedure is Born – NYT Mon, 4 Aug 2003 Two contrasting reports about experimental surgical procedures: The New York Times reports about a breakthrough surgical procedure to lengthen the intestine in babies born with an intestine so short it is dysfunctional and they are at…

Infomail Archive 2003

Infomail Archive 2003 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Dec 19, 2003: Eli Lilly Prozac UK Fact Sheet: “Not Recommended” for Children – PMDD Withdrawn in UK Dec 19, 2003: Not-So-Public-Relations: Drug Industry & Bioethics – is it casuistry or sophistry? Dec 18, 2003:…

Iowa seeks dismissal of lawsuit: Monster Experiment induced stuttering

Iowa seeks dismissal of lawsuit: Monster Experiment induced stuttering Fri, 11 Jul 2003 CNN reports that the State of Iowa seeks a lawsuit dismissed against the University of Iowa, claiming immunity. The suit was filed on behalf of three surviving people who had been victimized as children in a cruel…

AHRP Letter to the editor re: editorial ARDS trial

AHRP Letter to the editor re: editorial ARDS trial July 10, 2003. The New England Journal of Medicine. Volume 349:188-192 Number 2 http://content.nejm.org/cgi/content/extract/349/2/188 Note: The April 3, 2003 the NEJM contained an editorial in support of a controversial multi-site, clinical trial sponsored by the National Heart, Lung, and Blood Institute…

Hopkins Asks Patients to Waive Privacy Rights to Facilitate Research Recruiting – AP/ ABC

Hopkins Asks Patients to Waive Privacy Rights to Facilitate Research Recruiting – AP/ ABC Tue, 8 Jul 2003 In the 19th century doctors robbed graves to obtain cadavers for medical training purposes. Today, medical researchers are far more ambitious– they seek backdoor access to living patients for medical experiments. A…

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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).