UCSD Rejects Accusations of Not Getting Parental OK on Preemie Testing

Updated at 1:50 p.m. April 16, 2013

UC San Diego officials have rejected claims by a consumer-advocate group that its Hillcrest medical center didn’t have proper parental consent when it conducted tests on how to best treat premature babies.

Last week, UCSD and Sharp Mary Birch Hospital were among 23 institutions nationwide accused of conducting federal research without fully informing parents

Public Citizen, the advocacy group, wrote to Health and Human Services Secretary Kathleen Sebelius, asking for an apology about what it called a “highly unethical” study.

“This trial, funded by the National Institutes of Health … exposed 1,316 extremely premature infants to increased risks of either death or retinal damage, depending on which oxygen group they were randomized to,” said a 12-page letter dated April 10.

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.

On Monday, UC San Diego Health System spokeswoman Michelle Brubaker said all parents at UC San Diego Medical Center in Hillcrest were informed regarding the trial.

“The principal investigator was [Dr.] Neil Finer, former director of the Division of Neonatology at UC San Diego Health System,” Brubaker said via email. She said 42 infants were part of  “a comparative effectiveness trial of two modes in current use, not an experimental intervention.”

No infants were deemed to have been injured “as a direct result of participation in the trial” and no parents have complained, she wrote in reply to Patch questions.

At Sharp Mary Birch, Dr. Maynard Rasmussen, the primary investigator of the study, said 31 infants were part of his trial.

“All parents at Sharp Mary Birch Hospital for Women & Newborns were completely informed regarding the trial,” Rasmussen said via email Friday. “We have not identified any infants who were injured by the trial.”

He said results of the trial, analyzed as a group by the National Institute of Child Health and Development, were reported in the New England Journal of Medicine of May 27, 2010.

Public Citizen’s letter—signed by Drs. Michael Carome and Sidney Wolfe, deputy director and director, respectively, of Public Citizen’s Health Research Group—urged Sebelius “to promptly issue this apology and direct [the department’s Office for Human Research Protections] to immediately require additional corrective actions.”

The letter said many parents likely would have refused to let their newborns  take part in the study had they been adequately informed of, “and understood, the purpose and known risks of the research, as well as the differences in the experimental oxygen management for both ... oxygen groups compared to usual individualized oxygen management for premature infants available at those same hospitals.”

After learning Sharp Mary Birch’s response, Public Citizen’s Carome said via email: “Sharp Mary Birch Hospital ... appears to be expressing the party line that there was no problem with their consent form and process for this study.”

He said OHRP reported that it reviewed the [institutional review board]-approved consent form for the SUPPORT study for 23 institutions and “found similar deficiencies to those in the template consent form for this trial. If that is the case, then their consent form would have the same egregious deficiencies and the hospital is wrong.”

Wolfe added: “If the informed consent sheet is, as we suspect, the same as all the others then the hospital’s statement ‘All parents at Sharp Mary Birch Hospital ... were completely informed regarding the trial’ cannot be correct.”

Sharp Mary Birch—familiar to San Diego motorists for the stork statue atop its Kearny Mesa parking garage off state Route 163—is one of the busiest birth centers in the state, saying on its website “each year, more than 8,000 babies enter the world in the family-centered care environment.”

The stork, which has been refurbished over the years, was donated to Sharp after being in the 1960 Rose Parade.

In a San Diego Reader cover story of December 2011 titled “The unkindest cut” about high Caesarean-section rates at Mary Birch, hospital spokesman John Cihomsky was quoted as saying:

Sharp Mary Birch Hospital for Women & Newborns is the busiest high-risk, Level III delivery center in the state. Sharp Mary Birch not only delivers the most babies in the state, but we also deliver the most babies weighing less than 1500 grams. These very low birth weight babies are almost always delivered by cesarean section. In addition, we also care for many mothers with high-risk perinatal conditions, such as placenta accreta, and medical conditions that often require delivery via cesarean.

The Public Citizen letter said: “For infants whose parents chose not to be in the study, the oxygen would have been appropriately adjusted within this entire range to meet the specific individual needs of the infant, rather than attempting to confine the infant’s oxygen saturation to either the 85-89% range or the 91-95% range to meet the needs of the research.”

And Public Citizen said “study results demonstrated a statistically significant greater number of cases of serious retinal damage in the high-oxygen group compared with the low-oxygen group.”