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4,500 Premature Babies Sought as Guinea Pigs in NIH Experiments

[1]

Original Report: US Government Sponsored Medical Research Designed to Kill Babies [2]

by Vera Sharav
ALLIANCE FOR HUMAN RESEARCH PROTECTION

In a follow-up letter, Public Citizen has informed HHS Secretary Sebelius that 4,500 extremely vulnerable premature babies are being enrolled in 7 publicly funded experiments conducted by the National Research Network. This Network, comprised of 23 medical research centers, conducted the lethal oxygen experiment, SUPPORT. See: http://www.ahrp.org/cms/content/view/915/9/ [3]

This is one of the 7 examples:

Transfusion of Prematures (TOP) Trial: Does a Liberal Red Blood Cell TransfusionStrategy Improve Neurologically Intact Survival of Extremely Low Birth Weight Infants as Compared to Restrictive Strategy? (primary endpoints: death or significant neurodevelopmental impairment)

This study is comparing two different strategies for treating anemia (low red blood cell count) in extremely premature infants (birth weight of less than 2.2 pounds).

 The infants are randomly divided into two groups. Babies in one group receive blood transfusions whenever their red blood cell counts are moderately low (“liberal” transfusion group), and babies in the other group will receive blood transfusions only when their red blood cell counts are severely low (“restricted” transfusion group). The researchers will then determine whether one group of babies has higher rates of death or long term neurologicdamage compared with the other group. The study began in December 2012 and is expected to continue until August 2017. The researchers plan to enroll more than 1,800 extremely premature babies.

See:  http://clinicaltrials.gov/ct2/show/NCT01702805 [4]

Note that the primary endpoint of the newly uncovered current infant experiments–like that of the oxygen SUPPORT experiment–is listed as “death or severe disability.” That is an indication to us that the experiment is NOT geared toward improving the infant’s survival chances.

Public Citizen urges HHS Secretary to make the protocols and consent forms for these trials and all those conducted by the Network since 1986 public available on the HHS website, and order suspension of new enrollment in the ongoing trials until they are independently assessed for appropriateness and adequacy.

The Alliance for Human Research Protection calls for disciplinary action to hold medical researchers and their academic institutions accountable for violations of Federal research protections.  If research violated Federal protections, resulting in preventable injury or deaths, the senior researchers involved should be ineligible to obtain public funding, and their research privileges should be suspended for a probationary period during which they should enroll in medical ethics training. If ever they violate ethical / legal standards again, they should be banned from all research involving human subjects.

AHRP also calls for the revocation of the Federal licensure from academic institutions that have been the site of unethical medical research whose subjects suffered permanent injury or death—as happened in 2001 when Johns Hopkins University research license was suspended. http://www.hhs.gov/ohrp/detrm_letrs/jul01a.pdf [5]

Baby designed by God
by Dr. Amanda Hess & Dr. Jeremy Hess

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