June 5, 2014

The Government's Experiment in Manipulating Oxygen to Preemies

Sharyl Attkinson, an Emmy-award winning investigative reporter with CBS news until she resigned in March citing the network's liberal bias and lack of dedication to investigative reporter, is now reporting for a recently-launched news site The Daily Signal.  She starts off with a bang.

The question is whether  parents have to know that a government-funded study would randomly manipulate the oxygen delivered to their extremely pre-mature babies before they consent to a research study?

Did Government’s Experiment on Preemies Hide Risks?    A government-funded experiment put the lives of premature babies at further risk, and some parents say they didn’t know.

It was a national, government-funded experiment on 1,316 extremely premature infants in which their fate may as well have rested with the flip of a coin.
--
The government-backed study is called SUPPORT, which stands for “Surfactant, Positive Airway Pressure, and Pulse Oximetry Randomized Trial.” The experiment was conducted at 23 academic institutions from 2005 through 2009 under the National Institutes of Health, part of the Department of Health and Human Services.

All three women now say they never would have agreed to take part if they had known the NIH-funded study’s true nature—to randomly manipulate preemie oxygen levels. They discovered that just last year.
--
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, D.C.-based consumer watchdog group Public Citizen.

“Parents of the infants who were enrolled in this study were misled about its purpose,” Carome says. “They were misled to believe everything being done was in the ‘standard of care’ and therefore posed no predictable risk to the babies.”
--
In some instances, the results proved both disturbing and tragic.

More of the high-oxygen babies ended up with serious vision disorders. The low-oxygen preemies were more likely to die. The results, published in the New England Journal of Medicine in May 2010, sparked ethical questions and complaints. Companion studies being conducted in other countries were halted.

Of learning her baby had been part of an oxygen experiment, Sharrissa Cook says: “That’s more like playing Russian roulette to me. There’s no way I would say you could give my baby whatever you want him to have as opposed to what he needs.”

‘Input’ Stalls Agency’s Ethics Probe in Baby Oxygen Trials

The view of the HHS ethics office, directed by Dr. Jerry Menikoff, is that although medical doctors act in the best interest of individual patients, researchers do not.  Rather, researchers focus on what they consider the greater good. But as a trade-off, researchers must tell study participants about all the risks.
--
The entire dispute might be little more than an academic debate if it weren’t for one crucial factor: The Office for Human Research Protections, the ethics body within HHS, ruled that the consent process for the study violated federal regulations designed to protect human research subjects.  “The consent was significantly deficient,” Menikoff, director of the ethics office, says.

His office sent a stern letter to SUPPORT researchers on March 7, 2013 stating consent forms signed by parents of the preemies “failed to describe the reasonably foreseeable risks of blindness, neurological damage and death.”

It was a bombshell. One agency within HHS, the ethics office, had slapped another, NIH, with a formal ethics violation. This unleashed a torrent of pushback.  Little more than three months later, the ethics office appeared to back down.  In a follow-up letter, it formally suspended corrective action or punishment.
--
Lessons of Tuskegee Syphilis Experiment

Modern rules for research on humans were forged after the U.S. government’s Tuskegee syphilis experiment on black men in 1932 entitled, “Tuskegee Study of Untreated Syphilis in the Negro Male.” For 40 years, test subjects 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.

When a series of Associated Press reports exposed the study in 1972, an outcry led to new rules intended to prevent a repeat of the Tuskegee mistakes. Those rules mandate voluntary, informed consent from all human test subjects.

Parents Fault Medical Research Study for Putting Preemies in Harm’s Way

The discussion was academic until the Pratts took the stage—carrying pretty, 6-year-old Dagen, who was wearing a sundress and ponytails but looked fragile and thin in leg braces.

“We were guaranteed that the study wouldn’t hurt Dagen in any way, that it was just gathering information,” Shawn Pratt told the audience academics and research scientists, “and were shocked to learn the care she received was based not on what she needed, but on some protocol.”

Dagen’s father continued: “We want to know, as information comes in, why the risks and intent of the study were not clear. If it were clear, we wouldn’t have taken part in the study.”
--
At least one of three HHS panelists who moderated the meeting appeared dumbfounded by the Pratts’ personal story after lofty discussions about the greater good.

Attkinson on Preemie Study:' Government Made a Mistake'

According to Attkisson’s report, this resulted in a “government vs. government” dispute. “The federal government funded the study, basically approved the study, [and] oversaw the study,” she said in the interview. “I think it’s clear that the federal government, at the very least, made a mistake.”

The HHS ethics body’s attempts to enforce what it found to be violations of the parental consent process stalled because of “pressure by the research community and by senior officials in the federal government who really didn’t want this to go much further,” Attkisson said. Going forward, she argues, “There needs to be something that’s said at the end of all this. What did the researchers do wrong, what do they need to do to correct this and make sure the same type of thing doesn’t happen again?”
Posted by Jill Fallon at June 5, 2014 2:51 PM | Permalink