Dachel Media Review: NIH's "Tuskegee Preemie" Experiments
By Anne Dachel
Read Anne's commentary and view the links after the jump. The Dachel Media Update is sponsored by Lee Silsby Compounding Pharmacy and their OurKidsASD brand.
My update today is focused on a disturbing revelation about an NIH-funded experiment involving oxygen levels given to premature babies. This is being brought to light through the work of investigative journalist, Sharyl Attkisson, who has long been a hero to autism parents because of her coverage of the vaccine-autism controversy and how the government has steadfastly denied any link, despite mounting evidence to the contrary.
I was surprised to learn there's an office within HHS called Human Research Protections, that supposedly oversees ethics violations, yet as Sharyl tells us, their standards seem to change when pressure is applied.
There is a familiar name to us in the autism community, Dr. Arthur Caplan, "a noted ethicist." Caplan doesn't see this experiment on preemies as an ethics violation, which isn't surprising given his opposition to the idea that vaccines can cause autism.
SEE:
April 21, 2014 Age of Autism: Dealing with "Vaccine Refusing Parents?" How About Listening?
August 25, 2012
Older Dad Data Silences Vaccine Autism Debate
October 3, 2010
Age of Autism: Valid Concern for 60 Year Old Medical Travesty, What about Today?
Experts and officials have spent decades now defending an unsafe, unchecked, ever-expanding vaccination schedule and they see nothing immoral/unethical about injecting toxins into babies and pregnant women. I'm sure tinkering with the levels of oxygen given to tiny preemies would also be totally acceptable.
June 3, 2014, Did Government Experiment on Preemie Babies Hide Risks?
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. . . .
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. . . .
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. . . .
"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." ...
Medical personnel routinely give supplemental oxygen to babies who are born with immature lungs. Too much oxygen can cause severe eye damage, including a blood vessel disease and blindness called retinopathy. Too little oxygen can lead to brain damage and death.
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. Because, researchers say, all oxygen levels fell within the generally accepted range, they argue the babies received the same "standard of care" as babies not in the study. None of the consent forms mentioned a risk of death from the oxygen experiment. ...
Normally, medical personnel constantly adjust oxygen as preemies' conditions change, based on their individual needs. But the SUPPORT study was designed to keep infants in their randomly assigned range, despite a baby's individual needs.
And in a decision that one government source says shocked seasoned researchers when they learned of it, the babies' oxygen monitors intentionally were altered to provide false readings. The reason: so medical staff wouldn't be tempted to adjust oxygen out of the babies' study-assigned range.
"Nothing in the consent form explained the falsely reading oxygen monitors could lead to adverse decisions about care of the babies," Carome, who directs Public Citizen's Health Research Group, says in an interview. He calls both the study design and consent form unethical....
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.
Sharyl Attkisson: 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.
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.
At issue is SUPPORT, a study in which researchers at two dozen academic institutions randomly manipulated the oxygen levels of 1,316 extremely premature infants without providing their parents the full details of the methods and risks.
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. . . .
In an April 2013 letter to HHS Secretary Kathleen Sebelius, however, Public Citizen demanded that the government address alleged ethical lapses and apologize to the study families. In a follow-up letter Jan. 27, the liberal-leaning watchdog group said the design of the study was unethical because it lacked a control group to compare with the study babies and failed to adequately monitor their safety.
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.
"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, Carome says, and that senior leadership at HHS "bowed" to it. Having previously worked in the ethics office for 13 years, the director of Public Citizen's Health Research Group is familiar with agency politics.
How could they all have made, in the opinion of the HHS ethics office, such critical errors?
"I don't think this is ethically as troubling, as bothersome, as many of the critics do," says Arthur Caplan, a noted ethicist at NYU who defends the SUPPORT researchers. . . .
'A Little Bit of the Unknown'
Caplan argues that the study babies had the same "standard of care" as the non-study babies because their oxygen levels never deviated from the generally accepted range. The study posed minimal risk, he says, because it was merely "fine-tuning" a treatment rather than testing an experimental drug or brand new treatment.
"If SUPPORT is truly a study involving accepted standard of care, then there is a low bar for informed consent," Caplan says, adding: "In health care, each one of us is a little bit of a subject whether we like it or not. There's always a little bit of the unknown and there's always a little bit of research behind every medical intervention."
What is especially troubling for parents of vaccine-injured children is the lack of "informed consent" talked about in these pieces.
These parents were not told about what was really being done to their children. How similar is this to having parents follow the mandated vaccination schedule without a real understanding of the risks involved or the absence of any liability for the doctor and the vaccine maker? The Dachel Media Update is sponsored by Lee Silsby Compounding Pharmacy and their OurKidsASD brand. Lee Silsby Compounding Pharmacy is one of the largest and most respected compounding pharmacies in the country. They use only the finest quality chemicals and equipment to prepare our patients’ compounded medications and nutritional supplements. Customizing medication and nutritional supplements for our customers allows them to achieve their unique health goals.
Anne Dachel is Media Editor for Age of Autism and author of The Big Autism Cover-Up: How and Why the Media Is Lying to the American Public, which goes on sale this Fall from Skyhorse Publishing.
If anyone still has any doubts that our government is up to its eyeballs in a cover-up about the causes of Autism, perhaps they will reconsider after reading this.
Posted by: Denise Anderstrom Douglass | June 06, 2014 at 11:41 AM
Bob,
Of course, the researchers usually ARE the medical doctors.
Makes you want to sign right up, doesn't it?
Posted by: Linda1 | June 05, 2014 at 11:28 AM
But remember, as a society, we are expected to sacrifice our off spring for the greater good. So that others may live. You know it's ALL for the Greater Good because we have this idea that it's going to somehow propel the human species into a much safer environment and it will establish the human race, give us a strong hold on this whole earth thing. It's ok to sacrifice some as long as the strong survive....RIGHT?
Posted by: Rileysmom1204 | June 05, 2014 at 10:59 AM
"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."
Can someone please explain to me the "ethics" that allows "researchers" to do what is "NOT IN THE BEST INTEREST OF INDIVIDUAL PATIENTS?
I thought the Nuremburg trials had answered that question?
Posted by: Bob Moffitt | June 05, 2014 at 10:12 AM
Benedetta, I think you're probably right that they didn't learn a thing that will improve care for any individual infant.
It sounds to me like this research just confirmed something already understood to be the case with deceit throughout the process, so I wonder if the motivation behind the study was honestly represented as well.
And there's something about the whole notion of assigning anyone the title of "ethicist" that doesn't sit right with my sense of ethics.
Posted by: Jeannette Bishop | June 04, 2014 at 11:38 PM
I just thought of how Dr. Wakefield and his team were villified and ripped apart for trying to help children with autism and for trying to further the science. He was criticized for taking blood from children at a birthday party with proper consent of the children and parents. Compare that to this travesty where infants were randomized to receive set oxygen levels which is dangerous and inappropriate, where the monitoring equipment was rigged to hide the infants condition so that the oxygen levels wouldn't be properly adjusted to meet the infants real needs, and the consent for the "study" was a joke. But we will continue to hear that Dr. Wakefield is a fraud and that this study wasn't really a problem. It's unbelievable.
Posted by: Linda1 | June 04, 2014 at 10:05 PM
"...the babies' oxygen monitors intentionally were altered to provide false readings."
"Caplan argues that the study babies had the same "standard of care" as the non-study babies because their oxygen levels never deviated from the generally accepted range. The study posed minimal risk, he says, because it was merely "fine-tuning" a treatment rather than testing an experimental drug or brand new treatment."
Practitioners were kept in the dark about their patients' condition and treatment. Babies were not given individualized care. If parents did at home what these researchers did, they would without question be behind bars and there would be talk of the death penalty. It isn't that this was one crazy, rogue center that did this study. It was a multi-center study involving supposedly top centers and the US government. Plain and simple, to randomly manipulate anyone's oxygen levels is inappropriate. A person needs as much oxygen as a person needs according to his or her own condition, reflected in the close monitoring of the blood and through assessment. The caregivers must have correct information in order to accurately and sensitively evaluate and in order to make the best decisions. They were deliberately given incorrect information for the purpose of conducting an unethical experiment on human infants. Art Caplan, the philosopher, has no business even having an opinion here. The whole thing is outrageous - that they could even come up with such a study and outrageous that they are not all behind bars.
"Caplan says, adding: "In health care, each one of us is a little bit of a subject whether we like it or not. There's always a little bit of the unknown and there's always a little bit of research behind every medical intervention."
This guy is a little too lax, a little too free and easy regarding the difference between standards of care and experimentation. He is deliberately attempting to blur the lines in order to defend the indefensible. Medicine is an art as much as a science, BUT each patient deserves to have his own unique needs evaluated and met to the best of the medical practitioner's ability and available resources. Each patient is entitled to no less than individually tailored care. That is the OPPOSITE of what these babies received, which is CRIMINAL.
Posted by: Linda1 | June 04, 2014 at 09:53 PM
They changed the valves to make it look like they were getting something they were not.
The health care person there on the spot did not have information they needed to do their jobs.
How much you want to bet there is no sweet spot -- but adjusting as needed within the range is needed.
Some one with such power -- same attitude that they had when women from Eastern Kentucky went to Cincinnati for breast cancer treatment and instead were given specific doses of radiation -- just so we would know how many rads did what.
And when I was four and my great aunt died of brest cancer at a young age -- her husband sitting there so pitiful as his teenage daughters wept in the back ground said -- I would have taken to Cincinnati but it just seems like they just torture them with their treatments before they die, so I didn't.
He did not know what they were doing = but the word was out something was not right.
Do you think the greater good will appease God or Satan when they themselves die.
Posted by: Benedetta | June 04, 2014 at 08:50 PM
Just further proof that the term "medical ethics" is nothing more than an oxymoron, and the Hippocratic Oath is not worth the paper it is printed on. Of course, I have known this a very long time, so it does not surprise me. I've had to live with the fall out of their skewed sense of ethics every day since the last time I ever trusted one of them with the health and well-being of my child. I get daily reminders. If ell so sad for those parents. The public needs to understand that whenever they are approached to be in a "study" it is no more than a delicate term for "human experimentation."
Posted by: Starbuck75 | June 04, 2014 at 08:45 PM