The federal government has not done enough to oversee the treatment of America's foster children with powerful mind-altering drugs, according to a Government Accountability Office (GAO) report to be released Thursday.
ABC News was given exclusive access to the GAO report, which capped off a nationwide yearlong investigation by ABC News on the overuse of the most powerful mind-altering drugs on many of the country's nearly 425,000 foster children.
The GAO's report, based on a two-year-long investigation, looked at five states -- Florida, Massachusetts, Michigan, Oregon and Texas. Thousands of foster children were being prescribed psychiatric medications at doses higher than the maximum levels approved by the Food and Drug Administration (FDA) in these five states alone. And hundreds of foster children received five or more psychiatric drugs at the same time despite absolutely no evidence supporting the simultaneous use or safety of this number of psychiatric drugs taken together.
GAO Key Findings
Overall, the GAO looked at nearly 100,000 foster children in the five states and found that more than one-fourth of foster children were prescribed at least one psychiatric drug.
The GAO found foster children were prescribed psychotropic drugs at rates up to nearly five times higher than non-foster children, with foster children in Texas being the most likely to receive the medications compared to foster children in the other four states.
Watch the year-long investigation tonight on "World News with Diane Sawyer" at 6:30 p.m. ET
Although the actual percentages of children who received five or more psychiatric drugs at the same time were low in the five states included in the GAO report, the chances of a foster child compared to a non-foster child being given five or more psychiatric drugs at the same time were alarming.
In Texas, foster children were 53 times more likely to be prescribed five or more psychiatric medications at the same time than non-foster children. In Massachusetts, they were 19 times more likely. In Michigan, the number was 15 times. It was 13 times in Oregon. And in Florida, foster children were nearly four times as likely to be given five or more psychotropic medications at the same time compared to non-foster children.
Initially part of GAO's investigation, Maryland was later excluded from GAO's analysis "due to the unreliability of their foster care data" according to the report, a problem ABC News learned many states face.
Foster children were also more than nine times more likely than non-foster children to be prescribed drugs for which there was no FDA-recommended dose for their age.
For the most vulnerable foster children, those less than 1 year old, foster children were nearly twice as likely to be prescribed a psychiatric drug compared to non-foster children.
When Sen. Thomas Carper, D-Del., lead requestor of the GAO report, first learned of the report's findings, he said, "I was almost despondent to believe that the kids under the age of one, babies under the age of one were receiving this kind of medication."
ABC News has reviewed dozens of medical studies published in recent years that echo GAO's findings -- research showing foster children receive psychiatric medications up to 13 times more often than kids in the general population.
In some parts of the country, as many as half of foster kids are on one or more psychiatric medications. This, compared to just 4 percent of kids in the general population.
Dr. George Fouras, a child psychiatrist and co-chairman of the Adoption and Foster Care Committee of the American Academy of Child and Adolescent Psychiatry (AACAP), said, "There is an incredible push to use medications to solve these problems as if it is a magic wand."
The stories include kids like 11-year-old Ke'onte from Texas, whose journey was documented by ABC News over the past year and who will be testifying before Congress on Thursday about the overuse of psychiatric medications in foster children.
Neglected and often left home alone with his 1-year old sister, Ke'onte became a ward of the state at the tender age of four. Ke'onte was placed with a relative who, he said, beat him with belts, switches, and extension cords -- which not only left him with the physical scars on his body he showed ABC News, but, understandably, with anger and despair.
Simply too much for the relative, the state of Texas bounced Ke'onte between six foster homes and hospitals over just four years.
Along the way, Ke'onte's trauma was treated with an onslaught of psychotropic drugs -- powerful mind-altering medicines like the mood-stabilizer Depakote, the stimulant Vyvanse, the antidepressant Lexapro, clonidine for ADHD and the antipsychotic Seroquel.
"I was put on bipolar meds. I am not bipolar at all," Ke'onte told ABC News' Diane Sawyer.
Ke'onte was on at least 12 psychiatric medications while in foster care, up to four of them at the same time.
"I was on a whole lot of medicines that I should have not been on," Ke'onte told ABC News.
But Ke'onte is lucky -- a member of a select group of foster kids, about one in 10, who leave state custody to enjoy the security and stability of being adopted by a loving family, according to the latest data from the Administration for Children and Families.
And his new family, Carol and Scott Cook, were on a mission to get Ke'onte off drugs; he is now in therapy, beginning to heal. Additionally, his doctor now says Ke'onte doesn't have ADHD and he's not bipolar.
Meds Aren't Always the Answer
While almost all experts acknowledge children in foster care have more emotional and behavioral issues, experts ABC News spoke to do not believe this alone justifies the magnitude of the overuse of psychiatric medications in this vulnerable population.
"The general consensus is that when you're treating young children, you always try behavioral intervention before you go to medication," said Dr. Charles Zeanah, director of child and adolescent psychiatry at Tulane University.
Experts are also beginning to question the accuracy of diagnoses such as bipolar disorder and other mental illnesses in children, especially in foster children who may not always have access to comprehensive mental health services.
Stephen Crystal, director of the Center for Education and Research on Mental Health Therapeutics at Rutgers University, said while foster kids may be three times as likely to be diagnosed with bipolar disorder, "the validity of these diagnoses is uncertain, and the fact of being in foster care may itself increase the likelihood of psychiatric conditions being diagnosed."
While the National Institute of Mental Health reports schizophrenia affects just 1 percent of the population and bipolar disorder less than 3 percent of the population, antipsychotics have become one of the top-selling classes of medications in the United States, with 2010 prescription sales of $16.2 billion, according to IMS Health.
Concerned about numerous reports of waste and the abuse of psychiatric medications in foster children, Republican and Democratic United States senators, led by Sen. Carper, requested an independent GAO investigation on the growing problem nearly two years ago.
In the five states included in this week's GAO report, more than $375 million was spent on psychiatric drugs in 2008, $200 million of which was spent in Texas alone.
Medicaid spends at least $6 billion a year, nearly 30 percent of its entire drug budget, on psychiatric drugs, more than double what was spent in 1999, according to the Centers for Medicaid and Medicare Services.
GAO Holds HHS Accountable
The GAO report is an indictment on HHS's oversight of the nation's foster care children and asks that "HHS consider endorsing guidance for states on best practices for overseeing psychotropic prescriptions for foster children."
Several factors may be contributing to the increasing number of psychotropic prescriptions for foster children: greater exposure to trauma before entering the foster care system, frequent changes in foster placements and lax oversight policies on the part of states.
"You know, there are a lot of people you need to talk to, to find out as much as you can about what the child's behavior is like in a variety of different situations before you make a determination that you're going to use something like a very powerful medication to treat them," Zeanah said.
The GAO found that Texas, Massachusetts, Michigan, Oregon, and Florida each "falls short of providing comprehensive oversight as defined by the American Academy of Child and Adolescent Psychiatry" with regards to prescribing and overseeing the use of psychotropic drugs.
Currently, HHS simply provides "informational resources for states to consider for their programs" when it comes to psychotropic drugs provided to children in state custody according to the GAO.
States are not obligated to follow consent and oversight best principle guidelines set by the American Academy of Child and Adolescent Psychiatry for medicating foster children.
However, many states are also not following oversight provisions required by law, according to the Child and Family Services Improvement and Innovation Act passed in September 2011 and the Fostering Connections to Success and Increasing Adoptions Act of 2008.
In addition to providing guidance, HHS also has the authority to withhold federal funds from states that do not comply with strengthened oversight measures.
Sen. Carper said Congress has a responsibility, too -- "to try to get to the bottom of this, and armed with that information, to make sure that behavior is changed, that's going to be beneficial to children."
HHS Sends Letter to States the Day Before Thanksgiving
HHS was given an early look at the GAO report and issued a letter to states the day before Thanksgiving regarding the effective use of psychotropic medications among children in foster care.
"Too many states, I'm afraid, just don't know what best practices are," Carper said.
But states have been asking for help for years.
One state official told researchers at Tufts, "[We] need guidelines to determine whether medications are needed and, if so, for how long."
HHS said it will "offer expanded opportunities to states and territories to strengthen their systems of prescribing and monitoring psychotropic medication use among children in foster care."
Dr. Christopher Bellonci, a child psychiatrist and author of a 2010 Tufts study that showed nearly 50 percent of states either didn't have, or were still in the process of developing, policies regarding foster care psychotropic drug use, thinks HHS guidance for states on best practices, while good, are not enough.
Bellonci told ABC News the states should have to report pharmacy claims of actual psychotropic drugs given to foster children.
"We need to be able to benchmark states around one another, then at least it is all public record," Bellonci said.
Background on the Drugs
Antidepressants, anti-anxiety medications, antipsychotics, and mood stabilizers are some of the so-called psychotropic drugs -- psychiatric medicines that alter chemical levels in the brain, which impacts mood and behavior.
Of the psychotropics, antipsychotics, like Ke'onte's Seroquel and others like Abilify, Risperdal, Zyprexa, Geodon, Invega, Latuda, Fanapt, Clozaril, Saphris and Solian, are among the most powerful.
Of all the psychiatric medications, antipsychotics are, by far, the most prescribed, especially for foster children. Foster children are given antipsychotics at a rate nine times higher than children not in foster care, according to a 2010 16-state analysis by Rutgers University of nearly 300,000 foster children.
While doctors aren't exactly sure how or even why antipsychotics work, most experts believe antipsychotics block specific receptors in the brain, which are thought to be overactive in patients with symptoms of psychoses, such as hallucinations and delusions.
Antipsychotics were initially designed for schizophrenia and bipolar disorder. Only Seroquel, Abilify, Risperdal, and Zyprexa have very limited FDA-approval for use in children.
However, antipsychotics are being widely prescribed off-label, meaning for conditions the FDA has not approved them for, for things like agitation, anxiety, acting out, irritability, behavior issues and even as sleeping aids.
Dr. Jeffrey Thompson, chief medical officer for Medicaid in the state of Washington, said, "Nobody gets up in the morning to overdose kids. It just happens that it's a momentum in the system. Kids get aggressively diagnosed and sometimes we look for the easy solution, which is a pill over psychotherapy or better parenting."
Critics charge that, because of their sedating properties, antipsychotics are actually being used in foster care treatment facilities as chemical restraints.
Dr. Fouras is particularly concerned about the use of these drugs as chemical restraints.
"We are trying to put a nice shiny term that sounds [as if] 'oh, we're just restraining the kid,' [when] really what you are doing is just knocking them out to make them less of a problem for you," Fouras said.
This widespread and frequently unchecked use of antipsychotics is concerning considering the serious side effects of these medications. Antipsychotics change a person's metabolism, frequently cause significant weight gain and can increase the risk of diabetes.
In addition to tremors, muscle spasms and restlessness, antipsychotics can cause tardive dyskinesia, a permanent and irreversible condition where a person has involuntary movements of the tongue, lip, mouth, and arms and legs.
While less common with newer antipsychotics, each year 5 percent of people on antipsychotics will develop tardive dyskinesia, according to the National Institute of Mental Health.
Many experts are also concerned about the prolonged use of antipsychotics in children, given there are absolutely no long-term safety studies for their use in children.
Fouras said, "Some of these medications have only been out for 10 to 15 years, so that is not enough time to know what is going to happen over the long term."
ABC News' Keturah Gray (@kettynyc) contributed to this report.