Health Impact News Editor Comments:
We are updating this story with new video testimony from the August 28, 2013 HHS public meetings:
In this video, Shawn and Kerry Pratt appear with their daughter and read a written statement about the SUPPORT study. Shawn states that while they were led to believe that this study was simply a gathering of facts, “the SUPPORT study turned (their premature daughter) into a subject of an experiment, instead of a participant in a study.” Their daughter was involved in an oxygen saturation experiment, which they just recently found out about years later. There is evidence that this experimentation led to her cerebral palsy and other current ongoing health conditions. According to the parents, the original intent of the study was not provided to them prior to them agreeing to the study. The risks of the study were not clear, because if they were, they would not have consented to the study.
In this video, Sharissa Cook testifies that the risks of the SUPPORT program were never communicated, because if they had been, she would not have consented to participate. Both Sharissa and Kerry Pratt in the video above talked about how vulnerable mothers are when they have a premature baby in the hospital, and that their only concern is the health of their baby, not participating in some experiment that might one day help future babies in similar circumstances. Sharissa comments how the name of the experimenter alone, was misleading, as what mother in that situation would not welcome “support”? She had no idea her child was going to be part of an experiment on oxygen levels provided to premature infants.
As Vera Sharav of The Alliance for Human Research Protection states: “If you value your human right to say “No” to being subjected to a medical experiment in which you or your loved one may be exposed to risk of harm, then express your concerns and post your comments for the public record.”
Comment Here  until September 9th.
An Unethical Transfusion Experiment Targeting Premature Babies
Underscoring the importance of the public meeting regarding a concerted effort by NIH leadership and its powerful stakeholder allies to exempt invasive medical experiments that expose patients to increased risk from federal informed consent regulatory protections, is the exposure of another NIH-funded unethical, ONGOING, CURRENTLY RECRUITING experiment.
“Transfusion of Prematures”–TOP is a randomized two-arm comparative experiment seeking 1,824 premature babies as subjects–prior such experiments reported that restricting needed blood from premature babies causes neurological impairment.
The catalyst for the public meeting convened by HHS, to be held on Wednesday, August 28, in Washington at the Hubert Humphrey Bldg. 200 Independence Ave, from 9:00 AM to 5:00 PM, is the debate that was ignited by the unethical NIH-funded restricted oxygen experiment (SUPPORT ) whose subjects were 1,316 extremely vulnerable premature babies whose supplemental oxygen level was randomly restricted within the confines of the research, without regard for their oxygen need for survival–and without a current practice control group, thereby impeding safety monitoring of the experimental interventions. (Story here .)
Babies in the experiment were exposed to increased risk of death–237 babies died. The foreseeable increased risk of death–in particular for babies whose oxygen was restricted to the low range–was concealed from the parents in order to obtain their UNINFORMED permission.
Powerful research stakeholders, led by the director of NIH, are attempting to legitimize experiments such as SUPPORT by declaring that “comparative effectiveness research” (CER) poses no risk greater than “standard of care” and should be exempt from federal informed consent requirements. Those who have a financial stake in CER are attempting to secure an escape hatch for experiments they deem to be CER from informed consent disclosure requirements. They know that if the risks were disclosed, no responsible parent would give permission to subject their baby to the risks.
Public Citizen has uncovered yet another similar ONGOING, unethical experiment using the same modus operandi as SUPPORT: vulnerable premature babies are randomized to one of two extreme modes of life-support interventions. The experiment lacks the safety of a standard of practice control group; the serious risks are concealed from parents who are deceived by false reassuring statements in consent forms.
Like SUPPORT, TOP is funded by NIH and conducted by the Eunice Kennedy Shriver…Neonatal Network. (the participating institutions are listed below). Like in SUPPORT, not only have the risks for the babies been concealed from parents, parents have been deceived by consent forms falsely stating that the restricted blood transfusion protocol poses no risk.
Public Citizen has urged Secretary of Health and Human Services, Kathleen Sebelius, to immediately halt the experiment due to the serious ethical deficiencies.
- Order an immediate halt to the TOP trial, if you have not already done so per our prior request for such action.
- Direct OHRP to open a compliance oversight investigation into the trial.
- Direct OHRP to develop a plan for contacting the parents of subjects already enrolled in the trial and providing them with a complete and accurate description of the risks, purpose, and nature of the research.
- Initiate an independent investigation of the HHS system for review and oversight of HHS-funded human subjects research to understand how the system failed so miserably in both the SUPPORT study and the TOP trial. This investigation should include an assessment of all entities within NIH and other HHS agencies that played a role in the review, approval, and funding of the SUPPORT study and TOP trial. In addition, given the widespread failures across multiple IRBs that reviewed and approved the SUPPORT study and TOP trial, HHS should determine what systemwide actions are needed to prevent such failures from recurring.
- Identify and suspend any similarly unethical research involving premature infants funded by NIH or any other HHS agency.
Send your comments about the need for enforcement of federal research protections before Sept. 9, 2-13. Identify Docket HHS-OPHS-2013-0004: http://www.regulations.gov/#!docketBrowser;rpp=25;po=0;D=HHS-OPHS-2013-0004 
If the extremists within the NIH and the medical centers that have enormous financial stake in conducting “comparative effectiveness research” succeed in getting an escape hatch from informed consent, you or your loved one may become a human guinea pig without knowledge or consent in future unwanted medical experiments.
Institutions Conducting TOP Trial:
Brown University, Women & Infants Hospital of Rhode Island*§
Case Western Reserve University, Rainbow Babies and Children’s Hospital*§
Children’s Mercy Hospital*§
Cincinnati Children’s Medical Center*§
Duke University Health System*§
Research Institute at Nationwide Children’s Hospital*§
University of Alabama at Birmingham
University of Buffalo§
University of California, Los Angeles*§
University of Iowa*§
University of North Carolina at Chapel Hill§
University of New Mexico*§
University of Pennsylvania, Children’s Hospital of Philadelphia*§
University of Rochester*§
University of Texas Health Science Center, Houston
University of Texas Southwestern Medical Center at Dallas*
Wayne State University*§
*Institutions actively recruiting as of July 19, 2013
§Institutions with IRB- approved consent forms released by NIH in response to a Freedom of Information Act request
For more information, visit the Alliance for Human Research Protection site: http://www.ahrp.org/cms/content/view/18/87/ 
Baby designed by God
by Dr. Amanda Hess & Dr. Jeremy Hess
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