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Preemie Researchers Were Purposely Given Wrong Data, Group Says

UCSD Medical Center and Sharp Mary Birch Hospital purposely used oxygen monitors fixed to give erroneous readings as part of a nationwide study involving extremely premature infants, a consumer-advocacy group says.

Public Citizen went beyond its original assertions in April that parents at 22 hospitals weren't given complete information in asking for their consent.

The oxygen monitors used by doctors in experiments involving 42 preemies at the Hillcrest hospital and 31 at Sharp Mary Birch in Kearny Mesa were "deliberately miscalibrated so that medical personnel caring for the infants would not have accurate information about blood-oxygen levels," Public Citizen said in a statement.

"Due to that and other factors, the premature babies in the experiment were exposed to risks of serious, life-threatening harms, which were not divulged in study consent forms signed by their parents."

In fact, UCSD's consent form [attached as PDF] for its Hillcrest babies acknowledged the erroneous meters.

"The oximeters (oxygen monitors) used in this trial are FDA approved oximeters which have been modified for research purposes," said a consent form obtained through a Freedom of Information Act request.

UCSD said the modification "makes the monitors show a value which is either slightly higher or slightly lower than the true oxygen level when values are between 85 and 95%."

Sharp Mary Birch's consent form [attached as PDF] doesn't appear to mention the miscalibrated meters.

The trials were between 2005 and 2009, Public Citizen said, and split groups of babies into two groups, which got different oxygen levels--85-89 percent saturation and 91-95 percent saturation.

Public Citizen said half of the 22 consent forms for the so-called SUPPORT study mentioned that medical teams were given inaccurate information about the babies' oxygen levels, but "none of the forms described the impact of this experimental procedure on the babies' care or the potentially serious risks associated with it."

Ruth Macklin, a professor of bioethics at Albert Einstein School of Medicine in the Bronx, NY, was quoted by Public Citizen as saying: "Failure to disclose relevant information about risks in the informed consent process is a violation of research ethics."

In light of the new information, Public Citizen on Wednesday called on Health and Human Services Secretary Kathleen Sebelius to "immediately suspend enrollment in all ongoing or soon-to-begin clinical trials involving infants being carried out at a group of research institutions that make up the Neonatal Research Network," the same group that conducted the NIH-funded SUPPORT study.

In April, Dr. Maynard Rasmussen of Sharp Mary Birch told Patch: "All parents at Sharp Mary Birch Hospital for Women & Newborns were completely informed regarding the trial. We have not identified any infants who were injured by the trial."

UCSD Health System spokeswoman Michelle Brubaker said in April that all parents at UCSD Medical Center in Hillcrest were informed regarding the trial.

No infants were deemed to have been injured "as a direct result of participation in the trial" and no parents have complained, Brubaker said.

Comment is being sought from both San Diego hospitals on the latest accusations by Public Citizen.

Public Citizen's latest report also responds to arguments made by those defending the study and the adequacy of the consent process.

"Some claim that the criticism of this study will pose a threat to the advancement of medical knowledge and innovation," said Dr. Michael Carome, deputy director of Public Citizen's Health Research Group and co-author of the letter to Sebelius.

"However, the real threat to biomedical research is unethical research, which understandably undermines the public's trust in the motives and conduct of researchers."

Seven such trials expected to involve more than 4,500 infants are now ongoing, Public Citizen said.

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