The credibility of Pharma and psychiatry has taken a pounding. What does this mean for our kids?

by John McManamy


NO SOONER had the recognition dawned that depression and bipolar disorder do occur in teens and children than the inevitable backlash set in, a lot of it fully justified. Yes, there is a time and a place for putting kids on meds designed for adults, but there is also a time to refrain.

The FDA Investigates Antidepressants in Kids

A 2003 FDA analysis of 15 pediatric antidepressant trials found only three established efficacy, with only Prozac reaching the threshold of two successful trials generally required for approval. Moreover, the analysis uncovered worrying data that the kids on antidepressants engaged in more suicidal behavior than the kids on placebos.

Agitation and emotional lability are acknowledged side effects of these meds, usually short term. For kids with undiagnosed bipolar disorder, an antidepressant can result in manic and hypomanic episodes. Although the FDA did not connect these effects to suicidal behavior, in October 2004 it instructed manufacturers to warn on the product labeling that kids on antidepressants need to be carefully monitored as "there is concern that such symptoms may represent precursors to emerging suicidality."

The FDA also instructed manufacturers to put black box warnings on their product labeling, stating in part:

Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders.

The warning urges that doctors and patients closely monitor kids on antidepressants. Black box warnings are the strongest warnings that can be placed on a drug, but do not ban its use in children and adolescents. The FDA's UK counterpart, the MHRA, went further by contraindicating the use of all antidepressants in kids save Prozac.



Backlash Against Treating Kids with Meds

A lot of the credit for lighting a fire under the FDA goes to the antipsychiatry movement and its most prominent spokesperson, Peter Breggin MD, author of "Toxic Psychiatry" and numerous other books. The home page of his website seems designed to frighten parents, with tabloid style headlines such as, "New Review of SSRI Induced Violence, Suicide, and Abnormal Behavior." The article in question, however, is a closely reasoned document with convincing citations.

For years, Dr Breggin and others have been lone voices pointing out how drug companies have essentially bought off the psychiatric establishment, including leading academic researchers who have been paid to lend credibility to very questionable industry research. This research - most of it done on adults - has been used to justify coercing unsuspecting kids into submission (Dr Breggin's terminology).

As a result of the highly publicized FDA investigation into antidepressants in children in 2004, a wider public learned for the first time how drug companies routinely suppress negative findings and manipulate statistics to suit their own purposes. Academic researchers linked to these studies came across looking like industry publicists, while the FDA came under heavy fire for apparently sleeping on the job all these years.

In many ways, Dr Breggin has been vindicated. But Dr Breggin is also on record as saying there is no biological basis to ADHD, depression, and schizophrenia.




Bipolar and Antipsychotics

In 2007, diagnosing and treating bipolar in kids came under media attack following the tragic death of Rebecca Riley, aged 4, on what was apparently an overdose of an antipsychotic and a heart med.

The New York Times and Boston Globe and other publications treated the issue as a matter of bad parenting and bad medicine. Their point was that we are over-eager to attach psychiatric labels to "ordinary" behavior in kids and then over-react with "powerful" meds not FDA-approved for kids. A 60 Minutes piece on the topic came across as a Church of Scientology recruitment video.

Soon after, the doctor who had performed heroic duty in bringing pediatric bipolar to the attention of his disbelieving peers, Joseph Biederman of Harvard, came under fire for failing to disclose to his university his rather substantial financial connections with Johnson&Johnson, makers of Risperdal, thereby undermining the credibilty of his work and that of his colleagues.

Obviously, antipsychotics need to be regarded as a treatment of last resort. An editorial in the Oct 28, 2009 JAMA commented with a great degree of concern over the findings of a study appearing in the same issue. That study, led by Cristoph Correll of Zucker Hillside Hospital, NY, involved 272 treatment-naive kids, aged 4 to 19, taking second-generation antipsychotics. The mean weight gain over 12 weeks for Zyprexa was 19 (not a typo) pounds. For supposedly weight-friendly Abilify it was 10 pounds. More than half gained more than seven percent of their total body weight. Significant abnormalities in lipid profiles and other metabolic indicators were also noted, especially with Zyprexa.

The FDA has approved five antipsychotics (three in 2009) for the treatment of bipolar in children and adolescents, but the editorial cautioned that most of the trials in kids are short-term and have methodological limitations. JAMA also noted that pediatric mania overlaps significantly with disruptive behavior disorders and that meds treatment of bipolar disorder in youth often targets aggression and explosive behavior, "raising questions of specificity and the relative prioritizing of medications vs psychosocial interventions."



JAMA did acknowledge that "these medications can be lifesaving for youth with serious psychiatric illnesses such as schizophrenia, classically defined bipolar disorder, or severe aggression associated with autism," but it also strongly cautioned against their very considerable long-term health risks. On a final note, JAMA concluded:

Recent congressional investigations and media scrutiny have raised concerns over the pharmaceutical industry's influence on prescribing practices.

If JAMA's commentary comes on as strong, it pays to note that the editorial pulled a very significant punch by strictly limiting itself to the findings in the Correll study. Just as disturbing are the cognitive and sedating side effects of these meds.

All this raises the rather obvious question of why doesn't the FDA simply ban the use of antipsychotics for kids? The short answer is that the FDA regulates the sale of medicine rather than the practice of medicine. Bipolar and schizophrenia in kids are sufficiently devasting to warrant medical interventions. The FDA has flagged every conceivable health risk, leaving it to doctors to exercise their professional judgment.

You've Been Warned

Parents are entitled to take a skeptical approach and hold the doctor or psychiatrist to account for any medication he or she may recommend. This includes asking if the drug has worked well for other kids treated in his or her practice, as well as evidence of any research to show at least some evidence of efficacy and safety.

Parents should also be fully satisfied what the drug is being used for - what symptoms or side effects it is supposed to manage, how it works with other drugs in any cocktail, and how long the child is expected to remain on the drug. Since side effects can have a more pronounced effect on kids than adults, parents should not leave the office until the physician has recited the full litany of things that can go wrong and how they apply to your child's individual needs.

At a 2002 conference I attended on alternative approaches to meds, a mother of a bipolar child reported that after her son was put on meds, he became a vegetable, sleeping all the time and not engaging in the outdoor activities he once loved. Whereas the boy had once tested four to six years above grade level, he was now testing two years below. As the mother explained: "They felt they had solved my problem. I felt I lost my child."

But parents also swear by the positive benefits. Said Sheila McDonald, vice president of the Child and Adolescent Bipolar Foundation, testifying at an FDA public hearing in September 2004:

Just two days ago there was a posting on our website, and I quote a woman about her 10-year-old son where she says, "I thank God for each and every pill, each and every day that I don't have to listen to my son, my little boy say that he wishes he was dead."

Dr Breggin and others are undoubtedly right in saying that we are dispensing meds to too many kids with no concern for their real needs or for the permanent damage these meds may causing. But they are alsowrong in leavingthe impression that mental illness is not real and that there is not a time and place for these meds.

But who are the real sinners? As the 2004 FDA hearings most unequivocally brought to light, psychiatry was complicit with the pharmaceutical industry in overselling the benefits of at least one type of psychiatric medication while downplaying the harmful effects. For years, the FDA allowed this to happen. Heaven help that we need the likes of Peter Breggin to keep these guys honest. But the reality is we do.

In the meantime, do hold out hope for your child. Thoughtful meds treatment in the hands of a skilled clinician - as part of a program involving talking therapy and other non-meds interventions - can work wonders. But that dream clinician is only effective as the partnership you establish. Be advised: You have your work cut out for you.

This article is a substantial revision of an earlier piece, Jan 20, 2011, reviewed Dec 4, 2016


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