In modern medicine, there is a dilemma between the need to do research for the good of all and the right of human test subjects to know exactly what is happening to them. This incredible story starts in 2006, with a federal study of 1,300 extremely premature babies. What we found is that parents had no idea their babies were being entered into a risky series of experiments that could injure or kill them.
Little Dreshan Cook came into the world at one pound, 11 ounces fighting for his life. His mother Sharrissa was barely six months pregnant when he was born.
Sharrissa 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.
Sharyl: How big was he? Do you remember?
Cook: He would fit in your hand.
Shortly after his birth at the University of Alabama at Birmingham, Cook agreed to enroll Dreshan 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.
Sharyl: Your thought was, when you signed the papers, that what was going to happen?
Cook: That my son would be given 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.
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.
Sharyl: How much did he weigh?
Lewis: He was one pound 9 ounces. He was very tiny.
She says a hospital worker told her the study was just to collect data.
Lewis: She asked 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.
Sharyl: Did she tell you there was a possible risk of death?
Lewis: No, there were no risks discussed.
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 with too much oxygen, they could go blind. The SUPPORT study was searching for the sweet spot.
Dr. John Lantos, Director, Center for Bioethics, Children's Mercy Hospital in Kansas City, MO: 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?
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 Lewis and Sharrissa Cook.
Dr. 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 gonna save lots of lives.
On nearly every point, Dr. Michael Carome disagrees. He's an internationally recognized expert on research ethics at the watchdog group, Public Citizen.
Sharyl: 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 risks of the research.
Adding to the controversy, researchers didn't tell parents a remarkable fact: that they had altered the infants' oxygen monitors to give false readings, so the hospital wouldn't adjust them outside of their assigned low or high oxygen range.
Sharyl: Babies in the study were put on oxygen monitors that were rigged to give untrue or false readings?
Dr. Carome: That is correct.
Sharyl: In terms of things that have happened in the past, how bad is this?
Dr. Carome: I think this is extremely serious and about as bad as it gets.
Dr. Lantos: It seems to me that there's a lot of second-guessing, armchair quarterbacking and playing gotcha here.
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. Carome was once a senior leader at the Office for Human Research Protections.
Sharyl: The ethics office was in essence saying these consent forms were unethical?
Dr. Carome: 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.
Sharyl: These were prestigious institutions and the federal government. How does something like this slip past everybody?
Dr. 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. Lantos: Most of the criticism is not coming from parents but from regulators who, in my opinion, don't really understand the circumstances of oxygen therapy.
When the SUPPORT parents learned about the true risks, the surviving study children were six years old.
Sharyl: What thoughts did you have?
Cook: 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, you know, I'm supposed to protect him, but it was almost like I threw him out to the wolves, you know.
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-boggling.
Sharyl: If you had been told the risks involved and what they were really going to do, would you have signed him up?
Lewis: Absolutely not. No.
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. Lantos: The risks of not being in that study were comparable to the risks of being in that study and perhaps even higher.
Dr. Carome argues that's simply wrong.
Dr. Carome: There's no doubt that some babies, because they were in the study, died as a result.
Amid the criticism, the SUPPORT researchers and the 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. 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.
Today, Dreshan and Christian are both nine years old 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.
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.
Cook: He was born premature, at 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.
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.
Sharyl: Those who've conducted this study and the federal government at large, have basically said they don't think they did anything wrong?
Cook: I don't see how anyone can say nothing was wrong with playing Russian roulette with babies, babies who had no say so, no choice, no anything, just trying to survive.
Numerous SUPPORT researchers and the National Institutes of Health or NIH declined our interview requests. After the study revealed more deaths among babies on low oxygen, the American Academy of Pediatrics issued new recommendations. It now says preemies should be kept on the upper end of the oxygen curve. In other words, doctors should not do what the SUPPORT researchers did to half of the babies.