Moms Tricked Into Deadly Experimental Trial
by John Aman
Consent form didn't reveal risks to their premature babies
Vulnerable, first-time single mom Sharrissa Cook signed up for what sounded like a support group after she delivered her son, Dreshan, born at 25 weeks and weighing a feather-light 1 pound, 11 ounces. Instead, Cook, then 26, unknowingly put her critically ill, preemie son into a federally funded, experimental trial that subjected babies to the risk of brain injury, blindness and even death.
I was under the impression this was more of a support group where they would be holding our hand throughout the process, she told a public meeting hosted by the U.S. Department of Health and Human Services last August.
Cook's confusion stems from the experiment's name, SUPPORT, which stands for Surfactant, Positive Pressure and Oxygenation Randomized Trial.
Instead of a support group, what she actually joined was a controversial, federally financed research effort to determine the best oxygen levels for severely premature infants. I trusted them with my baby's life, Coo said last August. I feel there was a lack of information given to parents, and because of this, I feel taken advantage of and I feel responsible for my child's participation in this study.
Dreshan is now 7 years old and struggles with â myriad of health problems, according to Attkisson's report.
Shawn and Carrie Pratt also participated in the study after their daughter Dagen was born at 25 weeks, weighing 1 pound, 11 ounces. "We were guaranteed that the study wouldn't hurt Dagen in any way, that it was just gathering information", Shawn Pratt said at the HHS public meeting last August.
The Pratt's sole motivation was the health of their daughter, he said. We assumed her doctors felt the same and were shocked to learn the care she received was based not on what she needed but on some protocol. In our minds the SUPPORT study turned Dagen into a subject of an experiment, instead of a participant in a study. The preemies in the study were randomly placed into two groups and given either higher or lower levels of oxygen. Supplemental oxygen is life-giving for preemies, who have difficulty breathing because their lungs are not fully developed, but high oxygen levels can also lead to retinopathy of prematurity and vision loss.
A goal of the study was to identify a sweet spot between putting babies at risk for eye disease from too much oxygen and causing death because of inadequate oxygen. The risks were not disclosed to parents, charges Public Citizen, a left-leaning consumer advocacy organization founded by Ralph Nader.
The consent forms for the SUPPORT study had egregious deficiencies, and there was a failure to disclose the serious risks of the research, including the risk of death, brain injury and blindness from an eye disease called retinopathy of prematurity, says Michael Carome, M.D., director of Public Citizen's Health Research Group. We believe that had parents been adequately informed, many would not have enrolled their premature infants in this study. Actual results from the experiment reveal the risks. More infants died in the low-oxygen group 19.9 percent, or 130 out of 654 than did preemies in the high-oxygen group 16.2 percent, or 107 out of 662. Research community rallies in support
Many in the research community, including the NIH, fired back and vigorously defended the SUPPORT study. We are dismayed by the response of the OHRP and consider the SUPPORT trial a model of how to make medical progress, three medical professionals wrote in the New England Journal of Medicine.
NIH Director Dr. Francis Collins and two colleagues took the rare step of publicly disagreeing with OHRP in the New England Journal of Medicine. And they did more than disagree. Public Citizen obtained emails through a Freedom of Information Act request revealing a coordinated effort by senior NIH and HHS officials to interfere in OHRP's investigation. Specifically, NIH was given the opportunity to view and edit drafts of a second OHRP letter, dated June 4, 2013, in which OHRP placed on hold compliance actions against the University of Alabama at Birmingham, the SUPPORT study leader.
Such interference by NIH is unprecedented in my knowledge of the office, said Carome, who spent 24 years in the U.S. Public Health Service.
Despite the NIH intervention, OHRP's second letter affirmed its earlier determination that the study inadequately informed parents of the risks their children faced by enrolling in the experiment.Do researchers shade truth to recruit participants? Asked if researchers shade the truth when recruiting study participants, Carome listed the pressures at play.
Investigators are motivated to get their research done as quickly as possible so they can get grant dollars so they can get funding for research so they can get published in publications to advance their academic careers, he said. Too often I think investigators write consent forms where the risks are downplayed, where the benefits are overstated, where the nature of the research is not clear in order to avoid discouraging potential subjects from enrolling in the research.
Shawn and Carrie Pratt still don't know why researchers urged them to participate in a study that posed additional risk to their fragile, extremely premature daughter. And they wonder whether it is a factor in their daughter Dagen's health problems, which include multiple incidences of collapsed lungs, breathing problems and other life-threatening conditions, Attkisson reports. Dagen has cerebral palsy and had laser eye surgery at two months for retinopathy.
Why were we not fully informed of the risk and why is omitting information not considered lying? Carrie Pratt asked at a press conference last August, held on the sidewalk outside the Health and Human Services headquarters in Washington, D.C. We're very blessed that Dagen survived and has her eyesight, but every day that she cries because she is different, it just kills us. And we worry about her future as a special needs child, and especially as an adult.
[Note: This is not just about little premature babies used as research guinea pigs. It's about all of us, and you won't even know it's happening if informed consent is not required, or even if it is procured from those whose consent is compromised to begin with such as desperate and/or unsophisticated mothers (informed = details of the experiment, all risks and benefits, etc.; consent = given freely without any physical or psychological vulnerabilities). This is why research using prisoners was rejected years ago, simply because their incarceration compromised their freedom to give consent. This issue was profusely addressed and this research was harshly rejected last year by Vera Sharav and her AHRP (Alliance for Human Research Protection), and physicians, researchers, scholars, and representatives from many different organizations. In the process, an even larger issue became crystal clear that applies to all of us: the efforts to dispense with informed consent promoted by even those in federal and related offices supposedly dedicated to protecting human subjects in research -- for the 'greater good'.
The U.S. Belmont Report Already Requires All Citizens To Take Part in Research '˜For the Greater Good' (April 18, 2005), at: http://www.lifeissues.net/writers/irv/irv_90belmontreport1.html
See Sharav/AHRP articles re SUPPORT:
-- PART 1:
Medical Research Stakeholders Seek to Overturn Informed Consent Protection--Babies in Cross Hairs, at:
-- The OHRP and SUPPORT Another View, at:
N Engl J Med 2013; 369:e3July 11, 2013DOI: 10.1056/NEJMc1308015
-- PART 2:
Medical Research Stakeholders Seek to Overturn Informed Consent Protection--Babies in CrossHairs, at:
-- PART 3:
Bioethicists Promote the Business of Medicine, Not the Ethics of Medicine, at:
-- Informed Consent: The Subject's Right to Know
Here's what you should ask before you decide to give your informed consent to research