Unethical Medical Study Killed|& Blinded Babies, Class Claims

     BIRMINGHAM, Ala. (CN) – The University of Alabama exposed premature babies to death and blindness in a study that was “unethical by design,” parents claim in a federal class action.
     The defendants assigned premature babies with low birth weight varying oxygen levels by “the flip of a coin,” without disclosing the risks to their parents, five sets of parents with six children say in the complaint.
     The parents claim their children who were born or treated at The University of Alabama-Birmingham Hospital suffered permanent neurological and vision damage, and that other babies died as a result of the study.
     The complaint states: “The Office of Human Research Protection (‘OHRP’) recently determined that the University of Alabama’s ‘conduct of this study was in violation of the regulatory requirements for informed consent, stemming from the failure to describe the reasonably foreseeable risks of blindness, neurological damage and death,’ and further determined that ‘participating in the study did have an effect on which infants died, and on which developed blindness.'”
     Lead plaintiffs the Looney family sued University of Alabama Institutional Review Board Director Sheila Moore, its chairman Dr. Ferdinand Urthaler, the individual members of the board, and Dr. Waldemar Carlo, the neonatologist who led the study at the university’s hospital in Birmingham.
     The plaintiffs, whose babies were born weighing less than 2 pounds, seek to represent all babies who were injured in the study, and their families.
     “This case involves clinical research performed on infants born very prematurely with extremely low birth weights, who depend upon receiving the appropriate quantity of oxygen in order to survive and thrive, and depend upon the individuals responsible for their treatment to act in their best medical interests,” the complaint states.
     “The standard of care dictates that a physician treating a premature, low-birth-weight infant must select an appropriate blood oxygen saturation level of between 85 and 95 percent, as dictated by the infant’s specific medical needs, and that level should be adjusted in accordance with the infant’s individual specific needs and progress.
     “The plaintiffs, who were all born prematurely and with low birth weights, participated in a study at the University of Alabama that was conducted between 2004 and 2009 wherein they randomly received a fixed amount of oxygen (either low or high).
     “The study was unethical by design because, among other things, the infants who were the human subjects were randomized into the two arms of the study; in other words, the amount of oxygen initially received by each subject was determined by ‘the flip of a coin,’ and that amount was not adjusted in accordance with individual medical needs.
     “The study was further unethical by design because the informed consent document failed to disclose to the parents of the subjects any risks whatsoever with respect to which arm of the study their infants were randomized into, beyond the small risk of a minor skin breakdown.
     “The researchers should have known that, because of what is referred to as ‘the therapeutic misconception,’ parents of such infants desired one thing and one thing alone: that their newborn babies receive the best care to fit their individual needs and that they would never consent to their children receiving care based only on the need of researchers achieving some generalized knowledge.
     “The Office of Human Research Protection … recently determined that the University of Alabama’s ‘conduct of this study was in violation of the regulatory requirements for informed consent, stemming from the failure to describe the reasonably foreseeable risks of blindness, neurological damage and death,’ and further determined that ‘participating in the study did have an effect on which infants died, and on which developed blindness.'” (Parentheses in complaint).
     The OHRP is a branch of the U.S. Department of Health and Human Services.
     The plaintiffs’ babies were among 1,300 premature and low-birth-weight infants in the University of Alabama’s study, the “Surfactant, Positive Pressure, and Oxygenation Randomized Trial,” from 2004 to 2009.
     Instead of receiving oxygen based on medical needs, the babies were randomly assigned certain oxygen levels, which could lead to a severe eye disease known as “retinopathy of prematurity,” blindness, brain damage, chronic lung disease, and death, according to the complaint.
     “UAB-Birmingham served as the lead site in connection with the oxygen aspect of the experiment,” the complaint states.
     “The oxygen aspect of the experiment was a misguided effort to test the effects of receiving too little or too much oxygen on infants’ survival, neurological development, and likelihood of developing retinopathy of prematurity.
     “Infants, including the plaintiffs, were ‘randomized’ within the experiment such that, without regard to their individual medical needs, they randomly received either the lower or higher ranges of oxygen levels, which levels were not subject to adjustment.
     “Indeed, whether each plaintiff and each study participant would receive oxygen within the ‘low’ or ‘high’ range was determined by, in the words of the informed consent form, ‘the flip of a coin.'”
     The families claim the clinical trial violated federal regulations on human research because it failed to provide informed consent, it risked injuries that outweighed any possible benefits, and targeted vulnerable infants who came from difficult economic backgrounds.
     They say the protocol failed to spell out any risks beside the risk that the names of enrollees could not be kept confidential, and the risk of a skin breakdown.
     The consent form suggested that the study was “low risk,” that all treatments were “standard of care,” and that there was “no predictable increase in risk for your baby,” according to the complaint.
     But the families claim the Office of Human Research Protection concluded in March this year that the researchers had enough information to know that participation in the study might make a difference to an infant’s chance of survival or of developing blindness.
     “At all relevant times, the defendants were aware that infants who participated in the experiment would be placed at an increased risk of death (because of receiving too little oxygen), blindness (because of receiving too much oxygen), and lung disease and neurological damage (because of not receiving the appropriate amount of oxygen),” the complaint states.
     “Despite this, the informed consent document provided to parents at the University of Alabama, including the plaintiffs’ parents, failed to describe the reasonably foreseeable risks of blindness, neurological damage, respiratory ailments, and death.
     “Rather, in the section labeled ‘Possible Risks,’ the document simply stated as follows: ‘There is no known risk to your baby from monitoring with the pulse oximeters used for this study. The possible risk of skin breakdown at the site will be minimized by your baby’s nurse moving the oximeter to another arm or leg a couple of times a day.'” (Parentheses in complaint).
     The complaint adds: “The informed consent document also stated that, because both groups of infants (the ones receiving more oxygen, and the ones receiving less) would receive levels of oxygen within the standard of care (85 to 95 percent), there was no increased risk to the infants; in reality, as the OHRP found, it was not the standard of care for an infant to receive a random level between 85 and 95 percent, which would not be adjusted, and many infants therefore faced far greater risks by participating.” (Parentheses in complaint).
     The families say they would not have enrolled their children had they known the substantial risks they faced.
     They say their babies suffered severe and permanent visual and respiratory disease, developmental delays, brain damage, underdeveloped lungs and liver, and heart conditions as a result of their participation.
     They seek class certification and damages for negligence and breach of fiduciary duty.
     “A higher mortality rate in the lower oxygen saturation level was an unexpected finding of the study, therefore we could not communicate it as a potential risk in the parents’ consent forms,” Richard Marchase, UAB’s vice president for research said in a statement.
     “Infants in both of the study groups survived at the same or better rates than infants not enrolled in the study, even when controlled for the seriousness of their condition.”
     Marchase said that future consent forms will clearly list all possible risks of a study.
     The families are represented by Reginald McDaniel of Birmingham, and Alan Milstein with Sherman, Silverstein, Kohl, Rose & Podolsky of Moorestown, N.J.

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