This study had the potential to blind and kill premature babies and for the consent form to note that the only danger with participating in the study was the chance of getting a scratch on the skin.
New York, New York (PRWEB) April 12, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and/or medical devices, is commenting on a New York Times report about a study involving premature babies, in which parents were not given a full disclosure regarding potential harmful side effects.
Several prominent universities were involved in this failure to properly inform the one-thousand families who allowed their babies to participate in the study, according to an article published in the April 10, 2013, New York Times, which also noted that this research study is known as Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT).
The involved consent form that was used for the parents of the babies chosen for the study only warned that there was a potential for skin abrasions caused by the attaching of the devices, as well as a possible benefit of a baby not needing eye surgery, depending on which of two study groups the infant was placed into, the Times reported.
“This is morally reprehensible,” said Gary Falkowitz, managing attorney at Parker Waichman LLP. “That consent form would be a joke if the underlying issues here were not so serious; but how much more serious does it get? This study had the potential to blind and kill premature babies and for the consent form to note that the only danger with participating in the study was the chance of getting a scratch on the skin, and then adding that there was the possible benefit of not needing some enigmatic eye surgery, it all makes a mockery of what consent forms are there for, what they are all about.”
The information came to light due to the efforts of the Office for Human Research Protections, a federal agency that defends those who take part in government-financed research, according to the Times article, which added that the families still have not been notified about these risks.
The agency listed its conclusions in minute detail last month in a letter it sent off to the lead university involved: the University of Alabama at Birmingham. A total of 23 academic institutions were involved in the study – Stanford, Duke and Yale among them, according to the article.
According to the letter, the study “did have an effect on which infants died and which developed blindness, and that those risks were not properly communicated to the parents, depriving them of information needed to decide whether to participate,” the Times reported, adding that babies who took part were between 24 to 27 weeks of gestation, making them a very high-risk category already predisposed to death and eye disease, the article noted.
Findings of the study – which occurred between 2004 and 2009 and involved 1,300 infants – were published in the May 27, 2010, edition of The New England Journal of Medicine.
As noted in the letter, of the 654 total number of babies in the low-oxygen group, 130 died; and of the 509 total number of babies in the high-oxygen group, 91 developed an eye ailment – with some going completely blind.
As the Times article noted, the letter charged that the researchers possessed enough data to know, even before the study was launched, that the premature babies involved were at a greater risk for blindness or death than premature babies not taking part in the research.
Still, the consent form devised for the parents to sign only alerted them to the risk of the baby’s skin developing an abrasion caused by attaching the oxygen monitoring devices, the Times article reported, adding that the consent form also mentioned that there could potentially be less need for eye surgery, based on which group the infant had been placed in.
Richard B. Marchase, vice president for research at the University of Alabama at Birmingham, told the Times that the study kept the infants “within the standard band of treatment for oxygen levels — 85 to 95 percent — and that its findings would help inform a discussion by the American Academy of Pediatrics this year about standards for oxygen levels.”
The federal office responded in its letter by noting that the risks to babies participating in the study, however, “were not the same as those receiving standard care,” as quoted in the Times article. Further, the letter added, it was the consent form’s job to have revealed that “there is significant evidence from past research indicating that the oxygen provided to an infant can have an important effect on many outcomes, including whether the infant becomes blind, develops a serious brain injury or even possibly whether the infant dies.”
Researchers at the University of California, San Diego, wrote the consent forms, a University of Alabama at Birmingham spokesman said in the Times article, adding that approval was then granted by the review boards of all 23 institutions involved in the study, which the National Institutes of Health financed.
Dr. Marchase charged in the Times article that a similar group of infants who were born around the same time in the same hospitals as those who participated in the study, but who did not participate, despite their eligibility, died at a higher rate than babies in the study’s low-oxygen group.
Dr. Michael Carome, the deputy director of the health research group at Public Citizen, a consumer advocacy group, which released the letter to the media this week, noted that a study published in the Feb. 27, 2012, edition of Pediatrics determined that the infants who did not participate in the study, but had been eligible to participate, were in worse health from the start, and thus consequently more likely to die, according to the Times report.
Parker Waichman LLP is offering free legal consultations to victims and their families of those who participated in the Surfactant, Positive Pressure, and Oxygenized Randomized Trial (SUPPORT). Contact their office by visiting yourlawyer.com or by calling 1 800 LAW INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney