Human Testing

Sharyl Attkisson

Today we begin with a question of 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 Cook came into the world

Sharyl Attkisson

at one pound, 11 ounces, fighting for his life. His mother, Charissa, was barely six months pregnant when he was born.

Charissa Cook

I 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 caring for a preemie. Your thought was when you signed the papers that 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 Christian in the support study at the same hospital.

Bernita Lewis

Christian 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 research around the world was halted midstream. Bioethicist Dr. John 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 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.

Charissa Cook

What's wrong with

Sharyl Attkisson

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

Sharyl Attkisson

were put on oxygen monitors that were rigged to give untrue or false readings. That is correct. In terms of 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

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 indictment of the government-led 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.

Charissa Cook

The ethics office was, in essence, saying these consent forms were unethical. Absolutely.

Sharyl Attkisson

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 institutions and the

Sharyl Attkisson

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

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.

Sharyl Attkisson

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 a 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

Dr. Michael Carome

that's simply wrong. 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.

Dr. Robert Califf

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

Dr. Michael Carome

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

Sharyl Attkisson

Today, Drayshan 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 you 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 premature at 25 weeks.

Charissa Cook

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.

Bernita Lewis

What does that say?

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.

Dr. Robert Califf

Those who've conducted this study

Sharyl Attkisson

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.