After Hours: Government-Backed Medical Experiment on Premature Babies Gone Wrong

Sharyl Attkisson

Hi everybody, Cheryl Ackeson here. Welcome to another edition of Full Measure After Hours. Today, a fascinating but very sad tale of a government-backed experiment on premature babies that went wrong with virtually no repercussions for any of the scientists.

Sharyl Attkisson

All of us like to think that our public health institutions have our best interests at heart. That's basic. That's what we pay them to do. But too often that's proven not to be the case. We've talked about a lot of instances on full measure and I've written about them elsewhere. Now there are still lots of amazing scientists in federal government and at academic institutions. I know this in part because so many of them have become reliable sources for me. And they are so discouraged by the past 20 years of what's happened to medical information, what's happened to the science of studies. what's happened to federal agencies, medical schools, physicians groups, advisory boards, how they've been taken over by pharmaceutical and other corporate interests, and how sometimes ethical violations or even atrocities have been committed by the very people who are supposed to be looking out for our best interests. Historically, there have been medical experiments on the mentally ill, on foster kids, vaccine experiments in third world countries that would give you shivers. the syphilis experiments here in the U.S. on black men in Tuskegee. Well, one story that stuck with me since I first investigated it, I started looking into it years ago when I was at CBS News, is a glaring modern example of all of this. It has to do with experimentation on premature babies done, according to some of the mothers, without consent, violating the basic tenets of informed consent requirements for studies. Some babies died as a result of the study I'm talking about. And when a federal watchdog exposed what happened, instead of holding anybody accountable, the medical establishment and federal agencies went after the watchdog. And for a while, at least, he was left so beaten down, he was almost silent to other oversight. So today I'm going to play that story for you. It aired on full measure. And we're also going to include some discussion as to what happened after I published the report. So here we go.

Dr. Robert Califf

Today we begin with a question of

Sharyl Attkisson

human testing and the dilemma posed by the need to do research for the greater good and the right of human test subjects to know exactly what they're signing up for. Our incredible story begins in 2004 with a federal study of 1,300 extremely premature infants. Some parents say they had no idea they agreed to a risky experiment that could injure or kill their babies.

Charissa Cook

Little Drashan

Sharyl Attkisson

Cook came into the world at 1 pound 11 ounces. fighting for his life. His mother, Charissa, was barely six months pregnant when he was born. I

Charissa Cook

remember the night that I went into labor, I was a hysterical wreck. I was afraid. I was scared. I was in shock. How big was he? Do you remember? Yeah, he wouldn't fit in your hand.

Sharyl Attkisson

Shortly after his birth at the University of Alabama at Birmingham, Charissa agreed to enroll Drayshan in a study called SUPPORT. She says the hospital gave the impression she was simply signing up to get support in

Dr. Michael Carome

caring for a preemie.

Sharyl Attkisson

Okay, I'm stopping for a minute from the story. Notice the title of the study that they gave called Support, again, was used, according to the parents, to make the parents think they were signing up for something completely different than an experiment. They were actually allowing their premature babies to be used in an experiment you'll hear more about in a minute, but the parents say they were told, in some cases, that they were simply getting extra support for their premature infants, and they thought it meant some sort of extra care or assistance or help. Back to the story. What was, when you signed the papers, what was going to happen?

Charissa Cook

That my son would be getting the best care possible, and that even with his prematurity being as extreme as it was, that it would be okay because I had all of this help.

Sharyl Attkisson

She had no clue, she says, that the support study was actually a national experiment on the most fragile of test subjects, 1,300 extremely premature infants. Bernita Lewis also agreed to enroll her baby

Charissa Cook

Christian in the support study at the same hospital.

Sharyl Attkisson

Again, I'm pausing because you can't see the story right now, but these are African-American women. A lot of them were single moms, and a lot of them, as it turned out, were very poor. There were some questions when the problems with this study came to light as to whether scientists had intentionally perhaps recruited women that they thought wouldn't know better or wouldn't know who to complain to or wouldn't be able to figure out what was really going on. The scientists, of course, denied that was the case, but it certainly is a question to be asked. Back to the story.

Bernita Lewis

He was born at 27 weeks. How much did he weigh? He was one pound, nine ounces. He was very tiny.

Sharyl Attkisson

She says a hospital worker told her the study was just to collect data.

Bernita Lewis

She asked that would I be interested in Christian being in a study. They wanted to use his medical records to help babies in the future. And I told them absolutely they could use any records they wanted to use. Did she tell you there was a possible risk of death? No, there were no risks discussed.

Sharyl Attkisson

Support stands for surfactant positive airway pressure and pulse oximetry randomized trial. Funded with 20.8 million tax dollars, it was a collaboration among the National Institutes of Health and two dozen research bodies, including Duke and Yale Universities and medical schools. Researchers had good intentions. They already knew that without enough oxygen, preemies could get brain damaged or die. But too much oxygen, they could go blind. The support study was searching for the sweet spot.

Dr. John Lantos

And the question is, what level of oxygen would be optimum in order to save as many babies as possible without having the survivors become blind?

Sharyl Attkisson

To find out, the infants were randomly assigned as with the flip of a coin to either a low oxygen group or a high oxygen group. The study reached a tragic conclusion. The babies in the high oxygen group were more likely to go blind. Those unlucky enough to have been put in the low oxygen group were more likely to die. When the findings became known, similar

Bernita Lewis

research around the world was halted midstream.

Sharyl Attkisson

Okay, to summarize what we've talked about so far, there's this study going on that's putting the babies at some risk that the parents later said they weren't told there was any risk, which would violate every tentative informed consent and what studies are supposed to do. So these parents are signing up their very, very vulnerable, extremely premature infants for a study that's going to randomize them into either a group that gets high oxygen, which we know has one sort of risk, or low oxygen, which has another. But the parents aren't being told this, that the oxygen is not going to be adjusted to the individual need of the baby. They're actually just being put into randomized groups to see what the outcome is. More about this story right after a break. Do you have something to say and want to make your own podcast? Let me tell you how to do that for free with Anchor. Anchor has creation tools that let you record and edit your podcast right from your phone or your computer. You can even add any song from Spotify directly to your episodes. Anchor will distribute your podcast for you so it can be heard on Spotify, Apple Podcasts, and many more places. And you can make money from your podcast with no minimum listenership. It's all you need to make a podcast in one place. Download the free Anchor app or go to anchor.fm to get started. We're back with a continuation of the story about a study called SUPPORT that was conducted on premature babies. Some of the parents say without their consent, they were not told that their babies were going to be going into a study that carried a potential risk of death.

Bernita Lewis

Bioethicist Dr. John

Sharyl Attkisson

Lantos defended the support study as an expert witness against families who unsuccessfully sued for damages, including Bernita and Charissa.

Dr. John Lantos

This was a study that was well designed, conducted to the highest ethical standards with a completely adequate consent that was conducted without harming any babies and led to an important finding that's going to save lives. uh lots of lives

Sharyl Attkisson

on nearly every point dr michael carome disagrees he's an internationally recognized expert on research ethics at the watchdog group public citizen what's wrong with what they did in the study in your view

Dr. Michael Carome

the parents of these babies weren't told the exact purpose of the research the nature of the research in terms of how experimental it was and the rest of the research

Sharyl Attkisson

adding to the controversy Researchers didn't tell parents a remarkable fact. They had altered the infant's oxygen monitors to give false readings so the hospital wouldn't adjust them outside of their assigned low or high oxygen range.

Charissa Cook

Babies in the study were put on oxygen

Sharyl Attkisson

monitors that were rigged to give untrue

Dr. Michael Carome

or false readings. That is correct.

Sharyl Attkisson

Did you hear that? So as part of the study, these babies were put on oxygen monitors that would give false readings so that the hospital workers wouldn't adjust them into what would be considered an appropriate medical range to keep them in their assigned group. Back to the report. Things that have happened in the past, how bad is this?

Dr. Michael Carome

I think this is extremely serious and about as bad as it gets.

Dr. John Lantos

It seems to me that there's a lot of second-guessing, armchair quarterbacking and playing gotcha here.

Sharyl Attkisson

That's the gentleman again who testified in defense of the study. The debate would be purely academic if it weren't for an extraordinary turn of events. After questions were raised, the government agency that polices study ethics sided with critics and issued a searing

Charissa Cook

indictment of the government-led study.

Sharyl Attkisson

So this is a federal agency called the Office for Human Research Protections, which says that it provides leadership and the protection of the rights, welfare, and well-being of subjects involved in research and conducted or supported by the U.S. Department of Health and Human Services. So this agency took a look upon request at the study and sided with the critics and said that HHS and the study scientists had not complied with what they should have regarding the study. In a letter in 2013, the Office for Human Research Protections told researchers they violated federal regulations for informed consent for their failure to describe the reasonably foreseeable risks of blindness, neurological damage, and death. Dr. Carone was once a senior leader at the Office for Human Research Protections. The ethics office was, in essence, saying these consent forms were unethical. Absolutely. The concept of informed consent arose from an American tragedy, the U.S. government's syphilis experiment on black men in Tuskegee, Alabama in 1932. For 40 years, the men were neither told they were in a study nor treated for their syphilis. An outcry in 1972 led to new rules. Researchers are now required to disclose risks to test subjects and get their voluntary informed consent. And studies like support must be approved by ethics experts where the research is conducted.

Charissa Cook

These were prestigious

Sharyl Attkisson

institutions and the federal government. How does something like this slip past everybody?

Dr. Michael Carome

That is a great concern of ours. We looked at the... consent forms from 22 institutions, and they all failed in their duty to protect human subjects in this study.

Dr. John Lantos

Most of the

Dr. John Lantos

criticism is not coming from parents but from regulators who, in my opinion, don't really understand the circumstances of oxygen therapy.

Sharyl Attkisson

When the support parents learned about the true risks, the surviving study children were six years old.

Charissa Cook

What thoughts did you have? It was really emotional. A lot of crying, a lot of disbelief, a lot of heartache, and then it was anger.

Sharyl Attkisson

The way some of the parents found out that they had even been in a study was when there was advertising on the local radio station or reports in the media or somewhere else. reporting about the case and reporting about lawsuits that were arising. One of the women told me that she heard it on the radio and had to pull over and cry when she realized that was a study that her disabled child had been involved in as a premature baby, her now disabled child.

Charissa Cook

His mom, you know, I'm supposed to protect him, but it was almost like I threw him out to the wolves, you know.

Bernita Lewis

I was angry, and I couldn't believe that some... People who vowed, who took oaths to protect people would actually do this. That was mind

Sharyl Attkisson

boggling. If you had been told the risks involved and what they were really going to do, would you have signed them up? Absolutely not.

Bernita Lewis

No.

Sharyl Attkisson

Yet there were no apologies. Instead, the support researchers made a bold new claim that's particularly controversial. They said the babies were actually better off for having been in the study.

Dr. John Lantos

The risks of not being in that study were comparable to the risks of being in that study and perhaps even higher.

Sharyl Attkisson

Dr. Karom argues that's simply wrong.

Dr. Michael Carome

There's no doubt that some babies, because they were in this study, died as a result.

Sharyl Attkisson

Amid the criticism, the support researchers at National Institutes of Health dug in. They launched a public campaign of opinion letters and meetings to attack the Office for Human Research Protections and pressured it to suspend enforcement action. So this is an important part of the story. And in a TV piece, I can spend only so much time talking about any individual development. But the medical establishment and federal agencies went on this lobbying campaign. in the face of this very damning finding about the research that they had backed and supported and conducted. And the campaign consisted of saying, well, you know, if we tell everybody what the real risks are of all research, nobody will volunteer. Maybe we shouldn't have such strict rules for informed consent. They were turning this whole debate on its head into something else. And I sat through a whole day's worth of a conference at which this controversy was discussed. And that was the theme among a lot of the scientists in what I would call the medical establishment. The need to say, well, you know, we can't conduct a lot of research if we do disclose all the risks to everybody and then the greater good isn't served. So for the greater good, maybe we don't need to follow these traditional rules of informed consent. What they're saying is they could enlist somebody like you or me in a human study or get us to enlist our kids. into some sort of risky study without giving us the whole picture and justify it by saying if we don't fail to give the whole picture, nobody will volunteer and then we won't have a medical breakthrough that will help millions of people. It seems to be very twisted and contrary to the whole notion of do no harm, that your medical doctor is supposed to be looking out for you, the patient, not at some greater good that's been described to him or that he's aiming for outside of his treatment for you. Back to the story. The next voice you're going to hear is one of the doctors who spoke at this conference I talked about, Dr. Robert Califf at Duke University, who is more or less defending the behavior of the study scientists.

Dr. Robert Califf

The sensational claims of calling people unethical, I think, really detract from the serious discussion that needs to occur.

Sharyl Attkisson

So again, they're saying the serious discussion that needs to occur isn't about this study and the possibility of scientific misconduct and the possibility that babies died needlessly. The real scientific discussion, they said, as they tried to aim the attention away was, should we really have to give full informed consent for everybody? Because if we do, who will enter into these studies?

Dr. Michael Carome

Research community, many in the bioethics community and NIH have rallied together to defend this unethical research. And that's so that's part of the problem.

Sharyl Attkisson

Today, Drashan and Christian are both nine and doing well considering their challenges. But they have many lingering health struggles from respiratory problems to brain disorders. Their moms are left asking if the support study factors in.

Bernita Lewis

We don't know if it would have happened anyway or if it was caused by this. And it's just a game of just wondering. He was born

Charissa Cook

premature, 25 weeks. So we could expect some things, but to know that some others could have been prevented, you know, that makes me angry. And so to the doctors or to the researchers, best thing I can say is shame on you.

Sharyl Attkisson

What

Charissa Cook

does that say? double

Sharyl Attkisson

more than 80 years after the tuskegee experiments the support study has reopened painful wounds and is raising questions as to whether the protections for human test subjects are fundamentally flawed those who've conducted this study and the federal government at large have basically said they don't think they did anything wrong

Charissa Cook

i don't see how anyone could say nothing was wrong with playing Russian roulette with babies, babies who had no say so, no choice, no anything, just trying to survive.

Sharyl Attkisson

Numerous support researchers, the National Institutes of Health, or NIH, and the University of Birmingham at Alabama declined our interview requests. After the study revealed more deaths among babies on low oxygen, the American Academy of Pediatrics issued new recommendations to keep preemies on the upper end of the oxygen curve. In other words, doctors should not do what the support researchers did to half the babies. So that story aired in 2016. That study had taken place some years prior to that. And to this day, as far as I know, nobody was ever held accountable. Nobody was ever admonished for the behavior. There was nothing that was put out that said, we won't do something like this again. To me, it all serves as just another reminder that you have to look out for your own health. Trust your trusted doctors who know you And yes, read the information that federal agencies and medical institutions put out, but be aware that things are not always as they seem or as presented. And it makes it all the more important to fight against the idea of the medical establishment or federal agencies or third parties taking on some sort of decisive role in forcing us to take any particular medical action that they claim is best for us.

Sharyl Attkisson

I hope you enjoyed today's podcast. I hope you'll check out Full Measure every Sunday throughout the summer. We'll be back with a new and fresh season seven, our seventh year, beginning in September. I hope you'll check out my other podcast, the Cheryl Atkinson podcast. Subscribe to both of them. Leave a good review. Share them with your friends. Do your own research. Make up your own mind. Think for yourself.