There are a number of bloggers that regularly send out news of the latest findings reported in psychiatric journals and other media, and I thought it might be helpful to periodically post summaries of those reports. Here’s a brief recap of notable findings from June:

 

 

1) Psychotropics can cause eye problems.

 

S. Richa. “Ocular adverse effects of common psychotropic agents.” CNS Drugs 24 (2010): 501-26.

 

All psychotropic drugs may induce numerous and diverse unwanted ocular effects. These unwanted effects include blurred vision, galucoma, retinopathy, eye-movement disorders, and decreased ability to perceive colors and to discriminate contrast.

 

 

2) It’s easy for college students to fake ADHD

 

MJ Sollman, “Detection of feigned ADHD in college students.” Psychol Assess 22 (2010): 325-35.

 

In this study by University of Kentucky researchers, college students, after briefly reviewing information about ADHD on the Internet, were able to successfully “fake” ADHD symptoms and thus obtain a prescription for a stimulant. “The study confirms that self-report ADHD checklists . . . are probably of no value in differentiating individuals with ADHD from those faking the disorder,” the researchers concluded.

 

 

3) Britain reports 1.5 million “involuntary addicts” to benzodiazepines

 

 

(This is the sort of story that is virtually never reported in U.S. newspapers.)

 

4) Male neonates of mothers diagnosed with schizophrenia (and treated with antipsychotics) have abnormal brain volumes.

 

J. Gilmore. “Prenatal and neonatal brain structure and white matter maturation in children at high risk for schizophrenia.” American Journal of Psychiatry, published in advance online, June 1,2010.

 

In this NIMH-funded study, researchers reported that male neonates born to mothers diagnosed and treated for schizophrenia were found to have “several larger than normal brain volumes.” The researchers concluded that this was evidence that “prenatal and early neonatal brain development is abnormal in males at genetic risk for schizophrenia. “

 

 In other words, researchers saw this abnormality as evidence of a “schizophrenic” process already underway in the male neonates. But the mothers diagnosed with schizophrenia in this study were taking antipsychotics, which are known to cause changes in brain volumes. Thus, it may be that the abnormalities seen in the brains of the male neonates were due to the drugs, rather than to any underlying genetic risk for schizophrenia.

 

The female neonates born to mothers diagnosed with schizophrenia did not have “larger than normal brain volumes,” which of course leads to further doubt about any conclusions that can be drawn from this study.

 

 

 

 

When I first interviewed Brandon Banks, in the spring of 2008, while researching Anatomy of an Epidemic, he had recently entered Elizabethtown Community College in Kentucky, with dreams of becoming a journalist. Given his medical history, which included multiple psychiatric hospitalizations, this seemed like a bold dream, and few people in his life thought he would succeed at it.

 

But today, in this blog, I get to brag a bit about Brandon Banks.

 

Brandon Banks grew up poor in Elizabethtown, without a father at home. After graduating from high school in 2000, he moved to Louisville, where he attended college part-time and worked nights at United Parcel Service. There, he became depressed, and shortly after he began taking an antidepressant, he suffered a manic episode. "This was a serious shove into seriousness," he says.

 

Diagnosed now as bipolar, he came to understand that he would be struggling with this illness the rest of his life. During the next four years, he was hospitalized several times, and unfortunately, none of the endless combination of drugs he took -- Depakote, Neurontin, Rispderdal, Zyprexa, Seroquel, Haldol, Thorazine, lithium, and a number of antidepressants -- brought him lasting relief. Instead, he became a rapid cycler who suffered from mixed states, and he also developed a number of new psychiatric symptoms -- worsening anxiety, panic attacks, obsessive compulsive behaviors, voices, and hallucinations. At one point, his ability to concentrate declined so severely that Kentucky took away his driver's license.

 

"What my life became was staying at home all day, getting up in the morning and laying my pills out on the counter, taking them, and then going back to sleep because I couldn't stay awake if I tried. Then I would get up, play some video games, and hang out with my family," he recalls.

 

The story of his recovery from that dark moment is a long and complicated one. But suffice to say, it involved rejecting the idea that he had a "broken brain." Perhaps he was just "screwed up," he thought. Gradually, he regained a sense of hope about his future, about being able to make something of himself, and in the fall of 2008, he began pursuing his interest in journalism. He quickly became managing editor of the Elizabethtown Community College student newspaper, and under his leadership during the 2008-2009 school year, the newspaper won 24 awards from the Kentucky Intercollegiate Press Association. Banks personally garnered ten such honors for the articles he'd written, including first place in a deadline-writing competition.

 

 

I know there is an obvious lesson to be drawn from his story, but I have to confess that I am writing this note for a different reason. When Brandon Banks told me of his award, I felt such joy that I simply had to tell as many people as possible.

 

 

 

 

 

The case, United States ex-rel Law Project for Psychiatric Rights v. Matsutani, was unsealed earlier this year, and legal papers were recently filed that have brought this novel question -- which obviously has profound implications for the prescribing of psychiatric medications to poor children and adolescents -- into sharp focus.

 

The Law Project for Psychiatric Rights (PsychRights), which is headed by Alaskan attorney James Gottstein, filed its whistleblower complaint in April 2009. Known as a qui tam lawsuit, PsychRights sued on behalf of the federal government under the False Claims Act, which allows private individuals to pursue legal complaints against individuals or companies that are allegedly defrauding the government. In December, the federal government declined to join PsychRights in the case.

 

PsychRights named Alaskan state officials, hospitals, mental health agencies, psychiatrists, and pharmacies as defendants. In its complaint, PsychRights argues that the federal government has agreed to provide Medicaid reimbursement only for those outpatient drugs that are prescribed for an FDA-approved use or for a use supported by a medical compendium (such as the DRUGDEX Information System.) PsychRights maintains that the defendants defrauded the federal government when they billed Medicaid (or the federal Children's Health Insurance Program) for outpatient drugs that didn't meet this standard.

 

As part of its complaint, PsychRights identified 16 commonly prescribed psychiatric medications that have no "medically accepted indication" for youth under 18 years old, and it also identified the limited number of "medically accepted indications" that exist for 32 other psychiatric drugs. PsychRights compiled this list of "approved" uses by methodically going through the drug compendiums, and it serves as the evidential heart of the complaint, for it reveals that psychiatric medications are regularly prescribed to poor children for non-approved uses. PsychRights is asking the federal court to stop this practice (which it argues is harmful), and to pay hefty financial penalties for the fraudulent claims made to date. 

 

In early April, the defendants petitioned the court to dismiss the complaint, arguing that it was "fatally flawed" for a number of reasons, including several technical ones. For example, the defendants maintain that PsychRights has not "disclosed" private information that is required of "whistleblowers" in qui tam suits. But the defendants also argued --and this goes to the core legal issue of interest to healthcare providers -- that PsychRights has misinterpreted the applicable Medicaid law. Medicaid is a joint state-federal program, with each state establishing a Medicaid plan that must be approved by the federal government, and the defendants argue that a state may in fact choose to provide Medicaid reimbursement for outpatient drugs that are not FDA approved or "medically indicated" by drug compendia. The defendants argue that Alaska implicitly made that choice in regard to off-label use of psychiatric medications in children, and thus no fraud was committed.

 

The U.S. District Court in Alaska will likely take months to rule on the defendants' motions to dismiss the complaints. If the court rules on the central issue, it will help define whether Medicaid law supports off-label, non-compendia-approved use of psychiatric medications in children, or deems this commonplace practice to be medically unjustified.

 

 

In the past 15 years, the NIMH has funded a number of major, multicenter trials of drug treatments for mental disorders in adults and children, and although these studies have not been placebo-controlled, they still provide insight into how well drug-treated patients are faring over longer periods of time. In June, researchers will publish the one-year outcomes in the TEOSS trial, which assessed the merits of antipsychotics for early onset schizophrenia spectrum disorder, and thus it is now possible to summarize the results from five NIMH studies that looked at outcomes for patients treated with medications for 12 months or longer.

Adults

 

1) CATIE. In this study of antipsychotics for schizophrenia, 74% of the 1,432 patients stopped taking the assigned medication within 18 months, mostly because of "intolerable side effects" or the drug's "inefficacy." The atypical antipsychotics did not produce better results than the standard antipsychotic.

 

2) STAR*D. In this study of antidepressants, depressed patients who failed to respond to an initial medication were switched to another, with this process then repeated several times. In the initial stage of the trial, fifty-one percent of the 3,671 patients "remitted" at some point, which meant their depressive symptoms cleared. Then, during a one-yer followup study, 737 patients (20% of the original cohort) reported at some point that they were still doing well. But drop-out rates were high, and by the end of the 12-month followup, there were only 108 patients -- 3% of the original cohort -- still in the trial who had remitted and not relapsed.

 

3) STEP-BD. This large, 22-site study enrolled 4,360 bipolar patients from 1999 to 2005, and researchers conducted multiple randomized trials and naturalistic investigations to assess their outcomes. In regards to drug therapy, there were two primary findings. First, antidepressants were not found to be beneficial for bipolar patients. Second, in a one-year naturalistic follow-up study involving 1,742 patients, 409 (23%) remained well and in the trial throughout the 12 months. The remaining patients either dropped out (32%), or suffered one or more new mood episodes (45%).

 

Children and adolescents

 

4) MTA Trial. In this ADHD study, stimulants were basically compared to behavioral therapy, and at the end of 14 months, those treated with stimulants were doing better. Their core ADHD symptoms had abated to a greater degree, and there was a hint that their readings skills were better too.

 

The study then entered a second phase, in which the researchers periodically assessed how the children in the study were doing and whether they were taking a stimulant, and at the end of three years, "medication use was a significant marker not of beneficial outcome, but of deterioration. That is, participants using medication in the 24-to-36 month period actually showed increased symptomatology during that interval relative to those not taking medication." In addition, those on stimulants had higher "delinquency scores, and they were also now shorter and weighed less than their non-medicated counterparts.

 

At the end of six years, the results were the same. Continued medication use was "associated with worse hyperactivity-impulsivity and oppositional defiant disorders symptoms," and with greater "overall functional impairment."

 

5) TEOSS Trial. In this study of antipsychotics as a treatment for early onset spectrum disorder, 54 out of 116 youth (ages 8 to 19) responded to the drug treatment in the initial eight weeks. The 54 responders were then entered into a 44-week "maintenance" study, and at the end of that period, only 14 youth were still on the study medication, with the remaining 40 dropping out, or going off the medication because of "inefficacy" or "intolerable" side effects. Thus, 12% of the initial cohort responded to an antipsychotic and were still taking the medication at the end of one year.

To sum up, the NIMH studies documented the following long-term findings:

 

• 26% of schizophrenia patients in CATIE were able to stay on their assigned antipsychotic for 18 months.
• 3% of the depressed patients in STAR*D remitted and then stayed well and in the trial throughout the 12 month followup.
• 23% of the bipolar patients in STEP-BD stayed well and remained in the study during a one-year follow-up.
• Medication usage in the MTA ADHD study was a marker for deterioration at the end of three years, and associated with worse outcomes at the end of six years.
• 12 percent of the early onset schizophrenia spectrum patients in TEOSS responded to an antipsychotic and were still taking the medication at the end of one year.

 

Now that these outcomes are in, our society can better address this question:  Do these results tell of a successful paradigm of care?