Friday, August 23, 2013

AHRP- TOP--An Unethical Transfusion Experiment Targeting Premature Babies

Advancing Honest and Ethical Medical Research


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, 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.

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 UNIFORMED 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" should be exempt from federal informed consent requirements. Those who have a financial stake in CER are attempting to secure an escape hatch for experiment 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 have been concealed from parents, parents have been deceived by consent forms that 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-
(1) Order an immediate halt to the TOP trial, if you have not already done so per our prior request for such action. 
(2) Direct OHRP to open a compliance oversight investigation into the trial. 
(3) 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. 
 (4) 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. 
(5) 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!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 unwanted medical experiments.

Vera Sharav

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*§
Emory University*§
Indiana University*§
Research Institute at Nationwide Children's Hospital*§
Stanford University§
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

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