NIH trial weathers censure
Organization calls trial’s consent forms inadequate
Last week, the advocacy organization Public Citizen filed a letter of complaint with the Department of Health and Human Services about the National Institutes of Health’s Transfusion of Premature (TOP) trial, in which UNM was a participant. According to the Albuquerque Journal, the trial regards finding the right amount of hemoglobin with which to treat premature infants with anemia. Half of the infants enrolled in the program receive lower levels of hemoglobin, while half receive higher levels, according the article.
Michael Carome, the director of Public Citizen’s Health Research Group, said the group does not believe TOP informs parents of the full risks involved should their children be assigned to the low-hemoglobin group.
“We believe that the consent forms are not adequately informing the parents of the premature babies being enrolled in the research about many important facets of the research,” he said. “In order for human research to be ethical, one of the fundamental things it has to include is adequate informed — and I put emphasis on the informed — consent.”
Carome said his organization also has “fundamental concerns about the design of the study.” He said the study lacks a control group, or a group that would receive the usual transfusion care.
“The research only has two control groups: A liberal transfusion group and what’s called a ‘restricted transfusion group,’” he said. “Without that control group, you can’t monitor for possible harm of each of the experimental groups.”
Carome cited two prior studies that he says suggest babies who receive restrictive hemoglobin treatment “are more likely to have bad outcomes.” He said one study was conducted at the University of Iowa, while the other involved about 10 different institutions.
Both studies dealt with assigning infants randomly to different levels of hemoglobin, he said.
William Sparks, executive director of communications and marketing for the UNM Health Sciences Center, said UNM is one of 18 institutions participating in the TOP study. He said at the moment, UNM believes the study effectively informs parents.
“At this time we believe that the TOP study complies fully and with all applicable standards in regard to consent,” he said. “That’s our major statement.”
Sparks said Public Citizen made similar accusations regarding the SUPPORT study, which dealt with varying levels of oxygenation for pre-natal children. “What Public Citizen alleged in regard to that study was that parents weren’t duly informed of the dangers, risks or benefits of being on either side of that line — of more or less oxygenation,” he said. “When in truth … the purpose of the study (was) to determine what the best standards of care should be.”
The allegations made by Public Citizen regarding the SUPPORT study were eventually dismissed in court, Sparks said.
According to an official statement, UNMHSC said it “will not comment on the specifics of Public Citizen’s assertions regarding the TOP study, so as to avoid the serious confusion that previously surrounded the assertions made by Public Citizen regarding the so-called SUPPORT clinical study.”
Sparks said more information would soon be coming regarding the TOP study. However, he said UNM remains glad to be a part of the research.
“We have one of the revered neonatal centers in the country,” he said. “We have one of the few trauma centers for kids manned completely by pediatricians and experts in child medicine … and we’re honored to be participating in this important study.”