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NIH Accused of Interfering with Ethics Probe

A watchdog group claims that the federal agency improperly influenced the investigation of a study involving the treatment of preterm infants.

By | May 21, 2014

WIKIMEDIA, USAIDLast year, the US government’s Office of Human Research Protections (OHRP) conducted an independent investigation of alleged ethical lapses in a clinical trial that tested the effects of administering either high or low levels of oxygen to preterm infants. But it turns out that investigation wasn’t so independent after all, according to federal watchdog group Public Citizen. On Tuesday (May 20) the group released e-mails between officials at the National Institutes of Health (NIH) and those at OHRP conducting the ethical investigation of the $20 million, 23-hospital SUPPORT study.

Public Citizen, along with members of Congress, is calling for an investigation of top brass at the Department of Health and Human Services (HHS), which administers the NIH, over the alleged interference. “This interference involved NIH officials reviewing and editing a series of drafts of a pending OHRP compliance oversight determination letter regarding the SUPPORT study, as well as apparently allowing NIH to influence the timing of the release of that letter,” wrote Public Citizen to the HHS Inspector General in a letter that was cosigned by a number of academic researchers.

The SUPPORT trial ran from 2005 to 2009 and recruited more than 1,300 extremely premature babies, treating them with either low or high concentrations of oxygen (O2)—levels that were all within then-accepted standards of care. Researchers published the results of the study in a 2010 issue of The New England Journal of Medicine (NEJM). Those findings indicated that infants who were administered low levels of oxygen were morelikely to die, but also that high levels of oxygen could lead to blindness.

The OHRP wrote a March 2013 letter to officials at the University of Alabama, Birmingham (UAB), where the trial was centered, expressing concern that informed consent forms provided to parents enrolling their children in the SUPPORT study were inadequate to warn them of the potential dangers of the experimental O2 treatments. That letter recommended sanctioning the researchers involved in the trial.

But that June, the OHRP changed its tune. It suspended its call to sanction the scientists for failing to fully communicate the risks involved to the subjects’ parents in a second letter to UAB officials. Almost simultaneously, NIH Director Francis Collins and other agency officials published a commentary in NEJM defending the SUPPORT trial.

Public Citizen is claiming that officials at the NIH, including Collins, improperly influenced the OHRP’s decision to back off on its criticism of the SUPPORT trial. The emails and other documents they obtained detail revisions to the second letter suggested by NIH officials and a plan to coordinate the release of that letter with the NEJM commentary.

“OHRP regularly works with entities such as NIH, IRBs [institutional review boards] and others to ensure the protection of human subjects in research,” an HHS representative told ScienceInsider regarding the allegations of NIH interference.

Correction (May 22): The original version of this article incorrectly stated that infants administered low levels of oxygen in the SUPPORT trial were less likely to die. In fact, researchers found that they were more likely to die. This mistake has been corrected, and The Scientist regrets the error.

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Comments

Avatar of: Chaplindd

Chaplindd

Posts: 1

May 22, 2014

Serious error in this article.  The New England Journal of Medicine Article reporting the results of the SUPPORT study in 2010 indicated that infants who were administered low levels of oxygen were MORE likely to die, not "that infants who were administered low levels of oxygen were less likely to die" as reported by Mr. Grant.  Thus, there were adverse events in both arms of the study, very valuable information revealed by this study that can now allow neonatologists to provide their patients' parents with more valuable information for therapeutic decision-making.

Avatar of: Bob Grant

Bob Grant

Posts: 460

Replied to a comment from Chaplindd made on May 22, 2014

May 22, 2014

Hi Chaplindd,

 

Thanks for reading and catching my mistake. It has been corrected.

 

Thanks again,

 

Bob Grant - The Scientist

Avatar of: peteraleff

peteraleff

Posts: 2

May 23, 2014

The SUPPORT baby-suffocating experiment is a sign that medical research in this country is returning to pre-Nuremberg-Code standards of patient rights, or rather lack thereof.

The two oxygen regimens used were not the standard of care but each used only a part of that standard, and the researchers themselves had predicted that the lower oxygen concentrations would increase the death rate. They did indeed, and 23 "extra" babies predictably died in the low-oxygen group.
The researchers had lied to the parents on the consent forms and told them there was no risk involved. Moreover, the Director of the NIH and two of his Department heads even knowingly provided in their NEJM article false and patient-harming information about the oxygen needs of premature babies to cover up the ethics violations in that SUPPORT study.

Their inappropriate intervention with the OHRP is just the tip of the iceberg. For more background information about this unethical SUPPORT experiment, see http://retinopathyofprematurity.org/KnowinglyHarmfulMedicalResearch.htm

  You will find there details about the series of medical research frauds that led to this most recent experiment and to the most recent official cover-up of its Medical Ethics violations.

 

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