WASHINGTON -- Dagen Pratt's parents enrolled their tiny premature baby in a study of oxygen treatment believing she'd get the best possible care. They didn't understand it was an experiment to test what dose works best. No one mentioned any risks.


Now 6, Dagen struggles with cerebral palsy, and they wonder: Is that long-ago study to blame?


"Tell me that the Support study did not hurt Dagen in any way," her father, Shawn Pratt, challenged a government panel on Wednesday as his daughter, dressed in a bright sundress, stood quietly by.


A major controversy has erupted over what sounds like a straightforward question: How much should patients be told about the potential risks before they're enrolled in certain kinds of medical research?


The issue isn't about how to study a brand-new, unapproved therapy. All sides agree that those studies must fully inform participants that there's no guarantee the experiment will work, or even be safe.


Instead, the debate is about one of modern medicine's dirty little secrets: Doctors frequently prescribe one treatment over another without any evidence to know which option works best. There's no requirement that they tell their patients when they're essentially making an educated guess, or that they detail the pros and cons of each choice.


Researchers are supposed to outline all the risks when they study which commonly used option is best. But could that mislead patients into thinking research is riskier than their own doctor's best guess?


Federal health officials put that question to the public Wednesday, as they debate how strictly to regulate this type of research – a debate sparked by that study of premature babies who included Dagen Pratt of Kingwood, W.Va.


The tiniest preemies face serious risks, including death and disabilities.



Oxygen has been a mainstay of treating them, but doctors didn't know just how much to use. Too much causes a kind of blindness called retinopathy of prematurity. Too little can cause neurologic damage, even death. So hospitals used a range of oxygen, with some doctors opting for the high end and some for the low.


The Support study, conducted between 2005 and 2009, aimed to settle which end of that range was the best dose. It randomly assigned about 1,300 preemies at 23 hospitals to a lower or higher oxygen dose. To researchers' surprise, slightly more babies who got the lower dose died, a finding that has led to new standards for the care of preemies.


The problem: A government watchdog agency last spring ruled that researchers violated federal regulations that required them to spell out the risks of the study for parents. Nowhere in the consent forms that parents had to sign was death mentioned.


"This was a very, very important study to do," Dr. Jerry Menikoff, head of the Office for Human Research Protections, stressed Wednesday. "All we were asking for," he added, "is a couple of sentences to say there were risks."


He agreed with consumer advocates that a similar study in New Zealand phrased the issue more appropriately, saying the question is whether the lower dose "is safe and effective in reducing serious vision and lung problems without increasing mortality or neurodevelopmental disability."


But critics, including the head of the National Institutes of Health, argued that back in 2005, doctors didn't think the lower dose really posed a survival risk – the question was more about which dose did a good-enough job at saving their vision.


In fact, preemies who didn't enroll in the study – and got whatever range of oxygen their doctors deemed best – turned out to have a higher risk of death, said NIH Deputy Director Kathy Hudson.


Dr. John Lantos, a bioethicist at Children's Mercy Hospital in Kansas City, Mo., knows that firsthand. His twin grandsons were born during the Support study but weren't given an opportunity to enroll. One died soon after birth. The other today is thriving but suffered severe retinopathy and has poor vision.


"Nonvalidated therapy is often more dangerous than careful research," Lantos said, adding that the consent forms should make that clear as well. "Doctors just hate to say they don't know something. When they do say it, we should listen."


While the experts debated how to explain research risks, two families who traveled to Washington for the unusual meeting outlined a bigger hurdle: Reeling from the stress of having a vulnerable preemie, they simply didn't understand that they were participating in an experiment. And they still haven't been told what dose of oxygen their children received, and it's impossible to say whether lingering health problems are a consequence of the study or of being extremely premature.


Yet, they now wish they hadn't participated.


"I unknowingly placed my son in harm's way," said Sharissa Cook of Attalla, Ala., who wonders if vision problems experienced by her 6-year-old, Dreshan Collins, were caused by the study or from weighing less than 2 pounds at birth. "The only thing a mother wants is for her baby to be well."


Dagen's mother, Carrie, was more blunt with reporters: "Why is omitting information not considered lying?" she said. "We were told they would give her the best care every day."



Also on HuffPost:




Loading Slideshow...



  • Chance Of Having Twins Skyrockets


    In January, the <a href="http://www.huffingtonpost.com/2012/01/04/chances-of-having-twins_n_1183674.html">Centers for Disease Control and Prevention</a> reported that the numbers of twins in the U.S. has jumped in the last three decades: In 2009, 1 in every 30 babies born in the U.S. was a twin, compared to just 1 in every 53 in 1980. Why? Chalk it up to more and more couples using assisted reproductive technology, as well as an increase in women waiting to have kids until their 30s when the odds of having twins increases,<a href="http://www.huffingtonpost.com/2012/01/04/chances-of-having-twins_n_1183674.html"> AP said.</a>




  • U.S. Autism Rate Up


    In March, the Centers for Disease Control and Prevention released new figures on autism spectrum disorder in the U.S. and they were up: <a href="http://www.huffingtonpost.com/2012/03/30/autism-rate-increase-repo_n_1390721.html">1 in 88 children</a> is now believed to have autism, compared to the previous estimate of 1 in 110. Experts attribute much of the increase to better screening and diagnosis, AP reported, but that does not mean the findings aren't cause for concern. "Autism is now officially becoming an epidemic in the United States," Mark Roithmayr, president of Autism Speaks, said at a news conference.




  • 1 in 13 Women Drink During Pregnancy


    A <a href="http://www.huffingtonpost.com/2012/07/19/alcohol-during-pregnancy-_n_1686953.html">Centers for Disease Control and Prevention</a> survey from July found that 1 in 13 pregnant women in the U.S. drink alcohol. And of those who said they drank, 1 in 5 admitted to going on at least one binge -- having four or more drinks at once. <a href="http://www.huffingtonpost.com/2012/08/22/drinking-alcohol-pregnant-effects-children_n_1822880.html">A study</a> that came out a month later found that drinking during pregnancy has long-lasting effects on children's size.




  • Batteries Can Pose Serious Risk To Kids


    More and more kids are swallowing batteries, a Centers for Disease Control and Prevention report found, sending thousands of children to the ER each year. Between 1997 and 2010, nearly 30,000 kids up to age 4 were taken to the emergency room for battery related injuries, <a href="http://www.huffingtonpost.com/2012/08/30/swallowed-batteries-kids_n_1844412.html">MyHealthNewsDaily reported</a> in August. More than half of the cases involved small, circular button batteries.




  • AAP Throws Support Behind Circumcision


    In August, the <a href="http://www.huffingtonpost.com/2012/08/27/new-circumcision-guidelin_n_1826069.html">American Academy of Pediatrics</a> -- the U.S.' major pediatrics organization -- revised its policy on infant male circumcision, saying that the health benefits outweigh the risks. But the new guideline stopped short of recommending it routinely, stating instead that it should simply be available to parents who choose it for their sons. To the great surprise of no one, the policy was an immediate source of debate, with one "intactivist" leader <a href="http://www.huffingtonpost.com/2012/08/27/new-circumcision-guidelin_n_1826069.html">telling HuffPost</a> that the AAP had failed to address what she called the "real risks and harms of circumcision."




  • Breastfeeding Is On The Rise


    Also in August, the <a href="http://www.huffingtonpost.com/2012/08/02/breastfeeding-rates-cdc_n_1734381.html">Centers for Disease Control and Prevention</a> announced that more moms in the U.S. are breastfeeding their babies. Some 47 percent of moms breastfed their babies for at least six months in 2009 (the latest year for which there is data). That's up from 44 percent the year before. "The headlines 10 years back were, 'Mothers don't breastfeed enough; Is something wrong with mothers?'"Dr. Alison Stuebe, an OB-GYN and assistant professor of maternal and child health at the University of North Carolina <a href="http://www.huffingtonpost.com/2012/08/02/breastfeeding-rates-cdc_n_1734381.html">told HuffPost</a>. "We've recognized that this is crazy. Let's fix the system rather than going after moms.'"




  • More Kids Taking Antipsychotics


    The number of kids and teens being prescribed antipsychotics has soared, an August study in the <a href="http://www.huffingtonpost.com/2012/08/09/antipsychotics-adhd-study_n_1760602.html">Archives of General Psychiatry</a> found. Psychiatrists now prescribe the drugs in one out of every three office visits with children, and increasingly for off label use -- namely, the treatment of ADHD. The latter in particular, experts <a href="http://www.huffingtonpost.com/2012/08/09/antipsychotics-adhd-study_n_1760602.html">told HuffPost</a>, is cause for serious concern: "Although antipsychotic medications can deliver rapid improvement in children with severe conduct problems and aggressive behaviors, it is not clear whether they are helpful for the larger group of children with ADHD," study author Dr. Mark Olfson, a professor of clinical psychiatry at the College of Physicians and Surgeons of Columbia University, said.




  • Laughing Gas Safe For Delivering Moms


    Nitrous oxide, otherwise known as laughing gas, is a good way for women to manage some of the pain that accompanies labor, a <a href="http://www.huffingtonpost.com/2012/09/13/laughing-gas-delivery_n_1881496.html">Cochrane review</a> from September said. Though it's not at all popular here in the U.S. -- only 1 percent of women use laughing gas during birth, compared to the 60 percent of women who have an epidural during vaginal delivery -- the review concluded that it is both effective and safe for mom and baby.




  • Sleep Training is Safe


    Though sleep training can be a source of contention among parents and parenting experts alike, <a href="http://www.huffingtonpost.com/2012/09/10/infant-sleep-training_n_1865767.html">an Australian study</a> published in September concluded that two of the most popular methods are perfectly safe. "Controlled comforting" (basically a modified form of cry-it-out) and "camping out" (when parents sit in the room with their babies and pat or comfort them, but do not feed or cuddle them to sleep), did not have any impact -- good or bad -- on children when researchers looked at them at age 6.




  • Birth Complications Up In the U.S.


    They're still rare, but severe complications from birth are on the rise in the U.S., <a href="http://www.huffingtonpost.com/2012/10/24/us-birth-complications_n_2008771.html">Reuters reported</a> back in October. A Centers for Disease Control and Prevention study found that between 1998 and 2009, the rate of major complications, including things like severe bleeding and kidney failure, essentially doubled. Though <a href="http://www.huffingtonpost.com/2012/10/24/us-birth-complications_n_2008771.html">experts stressed</a> that most women who give birth are perfectly fine, there has been an increase in women giving birth at older ages, as well as women who are obese or have certain health conditions that up their risk, such as high blood pressure.




  • Boys Entering Puberty Earlier And Earlier


    Research published in October in the journal <a href="http://www.huffingtonpost.com/2012/10/20/boys-puberty_n_1987979.html">Pediatrics</a> showed that boys in the U.S. are entering into puberty at ever earlier ages: On average, boys are starting puberty six months to two years sooner than previous data showed. The study, which is among the first to look at the issue of early-onset puberty in boys, found that white and Hispanic boys now start to show signs of puberty when they are 10, while African American boys may start to show signs when they are 9 years old. What exactly this means isn't yet clear, <a href="http://www.huffingtonpost.com/2012/10/20/boys-puberty_n_1987979.html">study researchers said</a>, but it flags an issue that warrants further investigation.




  • Kids See 'Startling' Amounts Of Background TV


    A lot of parents limit the amount of TV their kids watch each day, but <a href="http://www.huffingtonpost.com/2012/10/01/children-tv-exposure-study_n_1923719.html">research published in October</a> found that many are nonetheless exposed to a lot of it -- in the background. The study, which ran in the journal <a href="http://www.huffingtonpost.com/2012/10/01/children-tv-exposure-study_n_1923719.html">Pediatrics,</a> found that kids are generally exposed to at least 4 hours of background TV per day (meaning it's on in the same room they're in, even if they're not watching directly) and children under the age of 2 are exposed to 5.5 hours every day.




  • Antidepressants May Carry Risks For Pregnant Women


    A November study in the journal <a href="http://www.huffingtonpost.com/2012/11/08/antidepressants-pregnancy_n_2094155.html">Human Reproduction</a> caused quite a stir when it suggested that SSRIs, a type of antidepressants, may increase the risk of complications when taken during pregnancy. Problems include risk of miscarriage, birth defects, neurobehavioral problems and more, the study researchers said. But there was significant push back from many mental health experts who rushed to write letters to the editor saying that the study ignored the many risks of untreated depression.




  • Preterm Births Hit 10-Year Low


    In November, the <a href="http://www.huffingtonpost.com/2012/11/13/us-preterm-birth-rate-hit_n_2118244.html">March of Dimes</a> released its annual preemie birth rate report card and, overall, the news was good: The U.S. preterm birth rate was the lowest it has been in a decade, dropping to 11.7 percent. While that is certainly welcome news, the U.S. still has a long way to go, March of Dimes experts <a href="http://www.huffingtonpost.com/2012/11/13/us-preterm-birth-rate-hit_n_2118244.html">told HuffPost.</a> Overall, the country still only earned a "C" and only four states (Vermont, Oregon, New Hampshire and Maine) earned an "A."