Follow the Science, page 3
A later investigation by United Press International (UPI) would uncover a number of unusual deaths among troops after anthrax and smallpox shots, including cases that resembled David’s. In an October 21, 2003, report entitled “Mystery Blood Clots Felling US Troops,” UPI Investigations Editor Mark Benjamin tells of soldier William Jeffries, thirty-nine, who suddenly collapsed in Kuwait and died a week later. Days before Jeffries’ death, his family said he was seen with “a scab on his arm from his recent smallpox vaccination.” According to one assessment, Jeffries had “the largest pulmonary embolism” the doctor had ever seen.
In November of 2003, amid pressure from news reports and findings from two civilian panels, the military finally admitted vaccinations “might have led to the death” of Lacy. She’d received “smallpox, anthrax, typhoid, hepatitis B, and measles-mumps-rubella” shots all in one day and experienced “a complex set of pulmonary, neurological and other symptoms” afterward. She also had inflammation in her heart. “She died due to a severe inflammatory process affecting her lungs, findings consistent with a diagnosis of systemic lupus erythematosus (SLE) or lupus,” according to the Defense Department in a statement. Military advisors concluded, “the weight of available evidence favors acceptance of a causal relationship between the immunization experience and the disease.”
Coincident with my exposé on David’s death, the feds were already “allowing” states to stop vaccinating civilian healthcare workers and first responders due to all the safety concerns. Only about 35,000 of the targeted one-half-million healthcare workers got the shot before the smallpox vaccine program died its unceremonious death.
In 2013, ten years after David’s passing, his wife appears on NBC’s Today show to promote National Deep Vein Thrombosis Awareness Month. “In the past ten years, we’ve established March as National DVT Awareness Month, and we’ve raised awareness by about twenty percent,” she tells NBC’s Matt Lauer.
Appearing alongside her on NBC is Dr. Geno Merli. Merli happens to be a paid consultant to Sanofi-Aventis, which manufactures a deep vein thrombosis therapy and a smallpox vaccine.
Chapter 2
Accidental Enlightenment
What I learned through reporting on the smallpox vaccine helped remove blinders I didn’t realize I was wearing. With my peripheral vision fully activated, I began to identify important scientific scandals all around—stories that few journalists were covering fully or fairly. The perversion of science is so commonplace, it’s fair to estimate there are thousands of real-world cases where it’s costing lives.
For all of the difficult stories I’ve covered on scientific misconduct, there’s one that occupies a special part of my brain where I cannot seem to tuck it away or forget it. I call it the Baby Oxygen study. Officially, it’s titled “SUPPORT.” Funded with our tax dollars, and with the participation of major establishment institutions, the story of the SUPPORT Baby Oxygen study drives home the disturbing callousness our government, public health officials, and top researchers are capable of when it comes to the most vulnerable among us. It helped me to understand, in a graphic sense, that some of the most trusted within our society are willing to commit life-threatening ethics violations. When caught, they circle the wagons and marshal forces to defend their bad acts, and take steps to cruelly silence the injured and smear those who would expose them.
It’s understandable if you approach this tragic story as if it were an anomaly, because it makes so little sense on a human level. Unfortunately, it’s indicative of countless examples of ethical lapses occurring on a daily basis in American medicine. In this instance, as you will see, medical authorities allegedly misled new moms into enrolling their premature newborns into a risky study. A medical watchdog group determined that some of the babies died as a result. The behavior of the medical experts involved violates the basic tenets of “informed consent,” a binding principle explicit in medical ethics and law. Informed consent requires doctors and researchers to provide patients with full information about the risks of treatments or studies, so they have a full understanding before they consent or decline. But wait until you hear what happened when the Baby Oxygen study scientists got caught, and what eventually became of a top official entangled in the mess.
The Tuskegee Precedent
Modern rules for research on humans were forged after the US government’s Tuskegee syphilis experiment on black men in 1932, entitled “Tuskegee Study of Untreated Syphilis in the Negro Male.” For forty years, test subjects in the Tuskegee experiment weren’t told they were part of a study, nor were they treated for their syphilis, even after penicillin was determined to be a cure in 1947.
An Associated Press series exposed the study horrors in 1972. An outcry led to new rules designed to prevent a repeat of the Tuskegee debacle. Now study scientists in America are required to tell participants about risks and get their written consent to take part in research. Additionally, study designs and consent forms must be approved by expert panels called Institutional Review Boards.
But decades after the Tuskegee experiment ended, the SUPPORT Baby Oxygen study would reopen painful wounds and raise serious questions about the actions at prestigious facilities such as Duke University Hospital and Yale University School of Medicine. How could they all have made, in the opinion of a government ethics watchdog, such critical errors?
The Awful Beginning
On October 11, 2006, twenty-five weeks into her pregnancy, Sharrissa Cook gave birth to a critically ill baby boy, Dreshan. Dreshan weighed in at a fragile 1 pound, 11 ounces. He lay motionless in the incubator, connected to tubes and monitors in the neonatal intensive care unit at University of Alabama at Birmingham Hospital.
“He was so tiny,” Cook tells me, pointing to a photo of her infant. “I was a first-time mom. I didn’t have a clue. I didn’t know what to expect.”
Medical personnel asked Cook, then a twenty-six-year-old single mother, to enroll little Dreshan in a study described simply as a program offering support and assistance. She readily signed on. “I remember them telling me they were a support group who would pretty much hold my hand through the developmental process,” Cook tells me. She says she had no idea what they were really going to do.
In reality, the SUPPORT Baby Oxygen study was a national, government-funded experiment on 1,316 extremely premature infants whose fate may as well have rested with the flip of a coin. Other single moms who were prompted to sign up their critically ill babies at University of Alabama at Birmingham Hospital describe similar misrepresentations.
Bernita Lewis, then a twenty-two-year-old student, told me she enrolled her premature newborn, Christian, after medical personnel said it was nothing more than permission to gather statistical data such as weight and height. And Survonda Banks, then twenty-one, unemployed and on public assistance, says someone handed her a consent form on her way into an emergency C-section at twenty-eight weeks of pregnancy. Banks remembers being told only that it was a way to help her baby, Destiny.
The government-backed Baby Oxygen study was named SUPPORT, which stands for “Surfactant, Positive Airway Pressure, and Pulse Oximetry Randomized Trial.” It took place at twenty-three academic institutions from 2005 through 2009 under the National Institutes of Health (NIH), part of the Department of Health and Human Services (HHS).
The three women I spoke to, all of them black, told me they never would have signed consent forms to put their fragile preemies in the SUPPORT study had they known its true nature, which they only discovered years later by happenstance. “[Dreshan] was already at a slim chance of surviving. Why would I make his chances of surviving more slim?” Cook later asks me, rhetorically. By the time I interviewed the moms, two of the children, Dreshan and Christian, were seven years old and struggling with a myriad of health problems. Little Destiny’s fate was far worse. She died within three weeks of entering the study. The mothers wonder, Did the experiment contribute to any of our children’s medical problems?
“The word ‘unethical’ doesn’t even begin to describe the egregious and shocking deficiencies in the informed consent process for this study,” says Dr. Michael Carome, an internationally recognized expert on research ethics with the Washington, DC–based consumer watchdog group Public Citizen. “Parents of the infants who were enrolled in this study were misled about its purpose.”
And you paid for it. Although federal officials repeatedly claimed the government didn’t know how much the SUPPORT Baby Oxygen study cost taxpayers, public documents later obtained through a Freedom of Information Act request put the figure at $20.8 million.
Oxygen Dilemma
Medical personnel routinely give supplemental oxygen to preemies with immature lungs—generally those born before twenty-five weeks. Too much oxygen can cause severe eye damage. Too little oxygen can lead to brain damage and death. The stated goal of the SUPPORT study was to precisely identify the lowest level of oxygen that would preserve vision, yet be sufficient to prevent brain damage and death. The results wouldn’t help the study babies at all, but could guide treatment of future preemies.
The biggest problem, said critics, lies in how researchers sought their answers. There were key differences in how they treated newborns in the Baby Oxygen study compared with those not in the study. Oxygen levels for the study babies were maintained within a generally acceptable range. But medical personnel were prevented from the normal act of constantly adjusting oxygen levels as the preemies’ conditions changed, based on their individual needs. The SUPPORT study arbitrarily assigned infants to either a high-oxygen or low-oxygen group and kept them in their randomly assigned range, despite their individual needs. And in a decision one government source says shocked even seasoned researchers when they learned of it, the babies’ oxygen monitors were intentionally altered to give false readings. The reason? So medical staff in hospitals caring for the sick babies wouldn’t be tempted to adjust the oxygen for the good of the individual baby! “Nothing in the consent form explained that the falsely reading oxygen monitors could lead to adverse decisions about care of the babies,” Dr. Carome told me in an interview. And none of the consent forms mentioned the risk of death.
More of the high-oxygen babies in the study ended up with serious vision disorders. The low-oxygen preemies were more likely to die. The predictable and awful results were glossed over in the study eventually published in the New England Journal of Medicine in May 2010. But some observers who read through the material carefully identified obvious ethical conflicts. A complaint was filed by a father who wasn’t involved in the study but read the published details and was apparently mortified.
The Office for Human Research Protections (OHRP) is an ethics body within the federal Department of Health and Human Services (HHS). It examined one of the complaints about the study and agreed that the consent process violated federal regulations. “The consent was significantly deficient,” determined Dr. Jerry Menikoff, director of the OHRP ethics body. His office sent a stern letter to SUPPORT researchers on March 7, 2013, stating that their consent forms “failed to describe the reasonably foreseeable risks of blindness, neurological damage, and death.” This was a bombshell. It implicated top medical institutions, such as Duke, Wake Forest, and Yale, in scientific misconduct.
What happened next is as alarming as the study itself.
The finding of an ethics breach unleashed a torrent of pushback—not against the study scientists but against the ethics watchdog. The scientists dug in hard. Dr. Waldemar Carlo, director of neonatology at the study’s lead site, the University of Alabama at Birmingham Hospital, denied wrongdoing on behalf of the approximately two dozen institutions that took part. In a letter to the New England Journal of Medicine in May 2013, Dr. Carlo said they did nothing wrong because the study babies’ oxygen levels were kept in acceptable ranges. He wrote: “Our consent forms were conscientiously drafted according to the Code of Federal Regulations and were based on the best available evidence.”
Inside the government, officials began heated efforts to attack and marginalize their own ethics watchdog. And forty-five research scholars and ethicists got together to sign a letter urging Dr. Menikoff to withdraw his determination of an ethics violation. “We believe that this conclusion was a substantive error and will have adverse implications for future research,” they wrote.
The pressure tactics worked. Less than six months after Dr. Menikoff’s original determination of ethics violations in the SUPPORT Baby Oxygen study, he backed down. His office confirmed the consent forms were deficient but formally suspended all corrective action or punishment saying the researchers meant no harm and may have been confused.
In response, Dr. Carome told me, “There’s no doubt in my mind that intense political pressure was brought to bear” from an academic research establishment that is dependent on the government, and that senior leadership at HHS “bowed” to it. Dr. Carome is familiar with agency politics. He used to work in the same government ethics office involved, the OHRP. A spokesman at HHS, which oversees OHRP, would not directly answer when asked whether senior government officials improperly intervened in the case to suspend corrective action.
Internal government emails later obtained through the Freedom of Information Act fueled suspicions of political interference. They show senior National Institutes of Health officials trying to tamp down the ethics probe while orchestrating a defensive commentary published in the New England Journal of Medicine. NIH officials “launched an aggressive campaign to undermine” the investigation into the SUPPORT Baby Oxygen study—“And regrettably found several willing partners for this campaign at the highest levels” of HHS, according to one watchdog.
Nonetheless, the federal government did come under enough pressure that it agreed to convene a big public meeting to examine the whole controversy. Hundreds of researchers and academics from around the globe gathered in person or via teleconference on August 28, 2013, to address the supposed confusion surrounding what constitutes “informed consent” in a study like SUPPORT. Even back then, I realized it was rare for esteemed researchers to be called on the carpet for unethical behavior. So I was anxious to hear how accountability would come.
My cameraman and I showed up the day of the conference at the Great Hall of the Hubert H. Humphrey Building near the US Capitol, where Health and Human Services (HHS) is headquartered. My plan was to sit in the audience, listen, and report on the event. I didn’t see any other reporters there. HHS officials controlled access to the meeting like Fort Knox. I had to register, show ID, sign in, and was required to have a government escort even to visit the bathroom. This meeting was to be the first step in the government’s effort to clarify and draft new guidance on the consent process for human research. But what I heard was startling.
Instead of officials expressing regret, instead of holding discussions about accountability and how to avoid a repeat, about half of the academics who spoke defended the SUPPORT study’s deficient consent process. Not only that, some actually used the forum to make the case to loosen up on “informed consent.” After all, they argued, when people are told all of a study’s true risks, they’re unlikely to take part, and the greater good won’t be served. I had to do a mental reset to see if I was hearing correctly. They seemed to unapologetically argue for the right to withhold safety information from study participants—to lie and trick them—because if the truth were told, nobody in their right mind would agree to the risks.
Dr. John Lantos, director of pediatric bioethics at one of the study sites, Children’s Mercy Hospitals and Clinics of Kansas City, Missouri, appeared to be on the side of telling patients less, not more. He said consent forms that make it sound like “death lurked at every corner” are counterproductive. “[T]hey are not empowering people to make informed choices, they are scaring them into making uninformed ones,” he insisted. In other words, he seemed to be arguing that the more truthful information you give people, the more uninformed they supposedly are. The less you tell them, the more informed they are.
Dr. Alan Guttmacher also defended the study. He led the branch of NIH that approved and funded SUPPORT, the Eunice Kennedy Shriver National Institute of Child Health and Human Development’s Neonatal Research Network. Dr. Guttmacher argued that the study added to the body of knowledge and had already helped other preemies. “We stand by this study as it was conducted and look for ways to do research even better, if there is a better way to do it, in the future,” he said, apparently refusing to admit the possibility that something had gone terribly wrong. Dr. Robert Califf, vice chancellor for clinical research at Duke University School of Medicine, also part of the experiment, urged observers to dial back the rhetoric. “Sensational claims of calling people unethical, I think, really detract from the serious discussion that needs to occur,” he said.
The discussion was academic until Carrie and Shawn Pratt of West Virginia took to the podium at the meeting. They were carrying their pretty, six-year-old daughter, Dagen, who was wearing a sundress and ponytails, but looked fragile and thin in leg braces. In May 2007, the Pratts agreed to sign up Dagen, a severely premature newborn, for the SUPPORT Baby Oxygen study at Duke. Like other parents, the Pratts say they were told that researchers were simply gathering information to help other children. “We never understood the study to be based on manipulating her oxygen level to meet [researchers’] needs,” says Carrie Pratt. Later confronted with the reality, the Pratts were shell-shocked. They had already lost a preemie son four years before Dagen was born. They say they can’t understand why medical professionals would have suggested enrolling their frail, newborn daughter in an experiment that could put her at further risk.
