Gosnell move over, we’re from the government…

Full Disclosure: Did Government’s Experiment on Preemies Hide Risks?

Sharyl Attkisson / @SharylAttkisson / June 03, 2014

 

Just 25 weeks into her pregnancy, Sharrissa Cook gave birth to a critically ill baby boy. 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 the University of Alabama at Birmingham Hospital.

“He was so tiny,” Cook recalls. “I was a first-time mom. I didn’t have a clue. I didn’t know what to expect.”

It was Oct. 11, 2006. Medical personnel asked Cook, then a 26-year-old single mother, to enroll little Dreshan in a study. She says they described it as a program offering assistance and encouragement to preemies—premature babies—and their families. She readily signed the consent form.

“I remember them telling me they were a support group who would pretty much hold my hand through the developmental process,” Cook says.

But in reality, the study was much more than that. 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.

Other single moms who were among those persuaded to sign up their critically ill babies at the University of Alabama at Birmingham Hospital describe similar misunderstandings of the study’s purpose.

Bernita Lewis, then a 22-year-old student, says she enrolled her premature newborn, Christian, after medical personnel told her it simply was to gather data such as weight and height.

And Survonda Banks, then 21, unemployed and on public assistance, says someone handed her the consent form on her way in for an emergency C-section at 28 weeks of pregnancy. Banks remembers being told only that it was a way to help her baby, Destiny.

‘Parents Were Misled’

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.

Dreshan and Christian are now 7 years old and both struggle with myriad health problems. Destiny died within three weeks. The mothers wonder: Did the experiment contribute to any of the medical problems of their children?

“[Dreshan] was already at a slim chance of surviving; why would I make his chances of surviving more slim?” Cook asks.

The NIH-funded experiment used the test babies in an attempt to find the sweet spot for preemies yet to be born: the lowest level of oxygen that would preserve vision, yet be sufficient to prevent brain damage and death.

To get the answer, researchers arbitrarily assigned infants to either a high-oxygen or low-oxygen group.

Playing Russian roulette’

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.

Read full article: http://dailysignal.com/2014/06/03/uninformed-consent-nih-sacrifice-preemies-sake-research/

Part 2: Full Disclosure: ‘Input’ Stalls Agency’s Ethics Probe in Baby Oxygen Trials

Pressure from government officials and eminent researchers appears to have pushed a federal agency to postpone enforcement action on violations it found in a government-financed experiment on extremely premature babies.

The agency, which polices ethics in health studies, says the controversy over the study of preemies highlights a “fundamental difference between the obligations of clinicians and those of researchers.”

That ethics body, called the Office for Human Research Protections, is part of the Department of Health and Human Services. The sponsor of the controversial experiment, the National Institutes of Health, is also part of HHS. Officials at both HHS and NIH provided “input” leading to the office’s delay in enforcement.

Gov vs. Gov

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.

Part 3: Full Disclosure: Parents Fault Medical Research Study for Putting Preemies in Harm’s Way

Thanks to Just Gene, H/T for the article.
“HE’S BAAAAAAAAAAK, THIS TIME AS THE FEDERAL GOVERNMENT”

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