Impoverished Youth; Our Neighbors in Distress, and at Risk

 This article is dedicated to 45 million children in America
(on Medicaid)

There is a great deal of discussion about youth being diagnosed — by general internists as well as psychiatrists — with ADHD, bipolar disorder, autism, irritability and depression and then joining the ranks of the pathologized and overmedicated on a march towards long-term distress.  Less attention has been paid to the 27 million children who, covered by federal and state Medicaid programs, are at high risk due to dangerous mismanagement of second-generation anti-psychotic drugs (SGAs). Recent reports have documented the brutal facts:

In 67% of cases of children covered by Medicaid there were significant quality of care concerns having to do with the misuse of second-generation antipsychotic Drugs. These concerns are:

• 17% the children were “too young” for the medication
• 41% the treatment was “wrong”
• 34% the treatment took “too long”
• 23% the “wrong dose” was administered
• 37% “too many drugs” were prescribed
• 53% there was “poor monitoring”
• 7% “side effects”

Children and youth who are at increased risk for mental health problems include those in low-income households, those in the child welfare and juvenile justice systems, and those in military families. 21% of low-income children and youth aged 6 to 17 have mental health problems, and these are the youngsters who are vulnerable and at high risk under the Medicaid programs.

57% of these children and youth with mental health problems come from households living at or below the federal poverty level. A greater proportion of children and youth in the child welfare and juvenile justice systems have mental health problems than those in the general population. 50% of children and youth in the child welfare system have mental health problems. Youth in residential treatment centers, 69% of whom come from the juvenile justice and child welfare systems, have extremely high rates of mental and behavioral health disorders compared to the general population.

The reasons driving the preference for the medical model in general, and medication of behavioral problems specifically, are financial as well as social & psychological; the seeming cost-effectiveness of drugs compared to alternative forms of therapy, and the convenience of medical prescriptions in managing a marginalized population that does not often question a doctor who has the power to prescribe – and often to enforce compliance – medication.

Recently I noticed that my 15-year-old neighbor, Cass, who has carried a diagnosis of ADHD since age 7, was gaining an alarming amount of weight.  Her mother, a single mom struggling financially, with no formal education and no family supports, has always been on public assistance and Medicaid, and so has her daughter. Our conversation went like this;

“I notice Cass is putting on weight, and she’s not coming over to see me anymore. Is anything going on with her?”

“I don’t know, she started getting fat the same time she started that new drug that the doctor put her on. Her special ED teacher said she wasn’t doing her homework so I took her in to see her general doctor and he added a drug he said would help.”

“Do you know the name of the drug?”

“No… it starts with an R, I think.”

“Did he say there were any side effects?”

“He said to call his nurse assistant if she feels sick.”

She has worried in the past that questioning the doctor would get her kicked out of California’s Federal- and State-subsidized “Healthy Family Medicaid Program.” She steered the conversation in a different direction.

My neighbor’s fears are not exaggerated. When I worked for Los Angeles County lack of funding indeed threatened to close health programs deny individuals coverage.

The 2015 Department of Health Services Report, which focused on the quality of care for children who are Medicaid recipients, states;

“Second-generation antipsychotics (SGAs) are a class of drugs used to treat psychiatric disorders, such as schizophrenia, bipolar disorder, and psychotic depression. SGAs are widely used to treat children enrolled in Medicaid who have mental health conditions. However, SGAs can have serious side effects and little clinical research has been conducted on the safety of treating children with these drugs.”

However, anti-psychotics are being prescribed off-label in increasing numbers to Medicaid-enrolled youth who have been diagnosed with ADHD, Depression, Bipolar and irritability disorders related to Autism. The federal report explains that it is not uncommon for Medicaid to pay for drugs that are “not yet” FDA approved because it is “difficult” to obtain FDA approval for Pediatric uses of drugs. If a doctor decides that the benefits outweigh the risks in a black box warning, he may choose a drug even if it is not “medically accepted” for the specific indication.

Three of the five “antipsychotic” drugs that are used on children – Aripiprazole, Olanzapine and Quetapine – carry a black-box warning of increased suicidal ideation. Additional drugs used for children are only approved for adults, and FDA-approved drugs for adults are commonly used off-label as well. Of note, the report states that only New York limits coverage of drugs to those prescribed for medically accepted indications. California (where I live) is among the states in which doctors can prescribe drugs for other than “medically accepted indications” The federal study states that in 2008 children in foster care in 5 states were prescribed psychotropic drugs — including antipsychotic drugs — at a higher rate than for children who are not in foster care. Hundreds of children had drug regimens that consisted of 5 or more psychotropic drugs.

All this is occurring even as massive efforts are being made to improve the “health” of our children. While the President’s wife embarks on an anti-obesity campaigns, children like Cass are gaining weight and will suffer unknown consequences of anti-psychotic drugs for decades to come.

To add to the injustices poor families and children suffer, the government sponsors numerous clinical trials of new anti-psychotic drugs that have not been FDA-approved. Poor families enroll their young children in these trials without being informed about side effects or long-term effects of the trial medication. Specifically, an article in Pharmalot reports, researchers found that 63% of consent forms failed to include the risks found in boxed warnings. They recently examined 4,780 clinical trial protocols that were active between January 2010 and December 2012 at one institution and identified existing 44 boxed warnings that applied to 57 protocols. Of those, 75% involved participants with life-threatening diseases.

The Federal report cited throughout this article gives many case examples, each one more alarming than the next. Here are just two examples;

Case Study 3 – a 16-year-old child diagnosed with bipolar disorder 

Monitoring—This child experienced significant weight gain while taking the SGA, but there was no evidence in the child’s record of monitoring of blood sugar, cholesterol, or other hormone levels in response to the weight gain.

Indications for use (wrong treatment)—The reviewer stated that the diagnosis which the SGA was prescribed to treat was poorly documented, saying, “Multiple antipsychotic agents were used with vague documentation of hallucinations [as the only explanation].”

Polypharmacy (too many drugs)—This child was prescribed a total of six psychotropic drugs during the review period, of which three were SGAs.

Duration (taken too long)—The SGA was prescribed to this child in response to a report of hallucinations. However, the medical reviewer stated: “When all medications were discontinued… hallucinations were not reported nor was the patient reporting suicidal ideation [i.e., suicidal thinking].” The SGA should have been discontinued as soon as it became apparent that its side effects were outweighing any treatment benefit.

Side effects—This child experienced paranoia, hostility, unstable mood, hallucinations, and suicidal thoughts. This child also experienced significant side effects potentially resulting from the prescribed drugs, including a 22-pound weight gain, insomnia, and edema (swelling) of hands and feet.

 

Case Study 2 – a 4-year-old child diagnosed with ADHD and a mood disorder

Monitoring—There was no evidence in the child’s medical records of any monitoring while the child was taking the sampled SGA.

Indications for use (wrong treatment)—This child was placed in the custody of child protective services at 4 weeks old and had a history of abuse and neglect and severe psychosocial issues, such as aggression, anxiety, and mood swings. The reviewer stated that individual, family, and behavior therapy should have been attempted before initiating treatment with drugs. However, there was no evidence in the child’s medical record indicating that such therapies were attempted. This child was prescribed four psychotropic drugs during the review period.

Dosage (wrong dose)—The reviewer noted that there is no appropriate dosage of the prescribed SGA for this child’s conditions

Despite ongoing revelations such as these, there is a hue and cry about children not having access to mental health services, however; those same services are frankly dangerous. There is government funding for more drug trials, and delivery of more antipsychotic drugs is in the pipeline.

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References:

A Study to Evaluate Pharmacokinetics, Safety and Tolerability after a Single Dose Administration of JNJ-31001074 in Pediatric Patients (12-17 Years) With Attention Deficit Hyperactivity Disorder (ADHD). ClinicalTrials.gov. Accessed July 5, 2015

Levinson, Daniel; Second Generation Antipsychotic Drug Use Among Medicaid-Enrolled Children: Quality-of-Care Concerns. Department of Health and Human Services; Office of Inspector General; March 2015. Accessed July 5, 2015

Silverman, Ed; Serious Risks About Existing Drugs Aren’t Given to Trial Participants. Wall Street Journal, Jul 29, 2015. Accessed July 5, 2015