Hospitals Dispute Failure to Disclose Clinical Study Risks for Premature Infants

Two dozen hospitals are under fire for allegedly not disclosing the risks of participating in a clinical study, which involved 1,300 premature infants. The study was to determine proper supplemental oxygen levels, and risks to the infants included death and blindness. Judy Woodruff talks to David Brown of The Washington Post.

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    Now the questions surrounding a research trial with newborn babies that allegedly didn't provide adequate disclosure to parents.

    The trial involved 1,300 infants at 23 hospitals who were born extremely prematurely between 2004 and 2009. Doctors were trying to better determine the right amount of supplemental oxygen they need to give to preemies. If the oxygen level is too low, babies can die. But if the rate is too high, it can lead to eye disease and blindness.

    In the trial, half of the babies were assigned to a lower dose, half to a higher amount. But, last month, the federal Office of Human Research Protections concluded that there wasn't appropriate informed consent. In a letter to the centers, it said hospitals failed to "describe adequately the reasonably foreseeable risks of blindness, neurological damage, and death."

    The nonprofit watchdog group Public Citizen brought that letter to light this week.

    And we get more now with David Brown. He's a reporter for The Washington Post.

    David Brown, welcome to the program.

    Explain in shorthand, what was this study designed to do?

  • DAVID BROWN, The Washington Post:

    Well, it was designed to answer a question that has been unanswered and that people have been trying to answer since the 1950s, when it was discovered that oxygen at high concentrations given to premature infants can cause very unexpectedly really serious eye damage and lead to blindness.

    The problem was that when oxygen was limited to many of these premature infants, their brain didn't get enough oxygen to develop. Many of them developed retardation. Some of them died. So there has been a real problem for literally half-a-century to determine what the right amount of oxygen is to sort of balance these two bad outcomes, on the one hand, death and brain damage, and on the other hand blindness.


    And what was the outcome of this study?


    Well, this study showed that, as previous studies had hinted, that if you limit the oxygen that premature infants are getting — this is all supplementary oxygen — this is more oxygen than you get from breathing air — but if you keep it at the lower end of what was the standard of care, then you reduce the chances of them becoming blind, but you slightly increase the chance of them dying.


    And along the way to that outcome, though, there are now questions being raised about whether parents were adequately notified about the risks.

    What is known about what parents were told?


    Well, parents were told that the current standard of care is to keep the amount of oxygen as measured by saturation of hemoglobin in a range between 85 percent and 90 percent, and that this was standard of care, and that all the babies were going to get oxygen that kept their blood at that — in that range.

    What wasn't adequately described is that there was going to be an attempt to essentially — well, to definitely create two groups. One-half of the babies would be randomly assigned to get oxygen at the low end of the normal range, and the others were randomly assigned to get oxygen at the high end.

    And the idea was to see if one of these two subranges was better than the other. And the fact that at one of them, there might be a higher risk of blindness and at the other end a higher risk of death, that really wasn't laid out in detail.


    But now there's a dispute. The University of Alabama at Birmingham, which was the lead hospital out of, I guess, 23 medical institutions that were engaged in this study, they are saying that throughout this trial, they — that physicians conformed to what's called the standard of care.

    But Public Citizen, the criticism is that they didn't provide — they didn't stay within the band of so-called standard of care. How is that going to be resolved?


    Well, they did stay within the band of standard of care as measured by these two — this range of hemoglobin saturation, namely 85 percent to 95 percent.

    Babies who are not in a trial like this, the physician with — conferring with the parents usually, decides someplace where in that range the doctor and the parents think might be best. And, actually, it's somewhat hard to keep infants from — at 1 percentage of saturation, they tend to bounce around.

    But the — even though that is the standard band of care, there is not enough knowledge to know what is the sweet spot in that — in that range of 85 percent to 95 percent. And this trial was trying to find that sweet spot. The people who ran it say everyone was in the standard of care, and there was actually some evidence that the lower end wasn't only protected against blindness, but might actually increase the survival of these kids.

    So, it just didn't go into the whole back story. How it will be resolved is — remains to be seen.


    Well, that's what I wanted to ask you.

    Attempts now being made to reach out to the parents of these 1,300 infants — of course, some of them did die. Some of them ended up with blindness or other vision issues. What's being done right now to reach out to those families?


    Well, it should be noted that babies were going to die, babies were going to go blind whether this trial was run or not, because that is just the hazards of extreme prematurity and oxygen therapy.

    At the moment, this office, OHRP, is negotiating with the University of Alabama at Birmingham as to what they're going to do. They have basically been told do a better job next time with informed consent. But whether this is going to involve a formal apology to the parents hasn't been decided.

    The people who've run the trial don't think they did anything wrong. They think that they had adequate explanation of the trial and truly informed consent. But the OHRP office says they didn't. And it's now a matter of negotiation, what they tell the parents.


    This is the Office of Human Research Protections we mentioned that falls under the Department of Health and Human Services.

    So, just quickly, David Brown, who or what is to determine now whether there was liability in all this?


    Well, of course, that's a big question that the Office of Human Research Protections doesn't want to the address. In fact, I asked them about that today.

    If there is an apology, and that can be interpreted by a lawyer as some statement of culpability and liability, there probably will be lawsuits. But it's clear that blindness and death were going to happen regardless of the study. And it may be difficult to pinpoint which babies actually had a bad outcome because of the study.


    David Brown, reporter for The Washington Post, thank you very much.


    You're welcome.