Map of life expectancy at birth from Global Education Project.

Sunday, May 14, 2006

Now this is really seriously over the line . . .

Some "doctors" at Harvard Medical School -- led by one Joseph Biederman, MD -- are running a clinical trial to test the atypical anti-psychotic Quetiapine in pre-schoolers -- kids 4 to 6 years old -- who have been "diagnosed" with bipolar disorder. Read all about it here in case you are incredulous.

Applying the diagnostic label of bipolar disorder to a 4-year-old strikes me as an outrage to begin with. Quetiapine is prescribed for people with schizophrenia, which is a serious, disabling, and incurable disease, but most people can't tolerate it and stop taking it. It is also sometimes prescribed to adults for the manic stage of bipolar disorder but that ought to be a last resort, in my view. Here are some of the side effects, from Medline Plus:

* drowsiness
* dizziness
* agitation
* pain
* weakness
* dry mouth
* vomiting
* indigestion
* constipation
* stomach pain
* headache
* excessive weight gain
* thinning of hair or nails

* fainting
* seizures
* shaking of hands that you can not control
* changes in vision
* rash
* uncontrollable movements of your arms, legs, tongue, face, or lips
* painful erection of the penis that lasts for hours
* fever
* very stiff muscles
* excess sweating
* fast or irregular heartbeat
* unusual bleeding or bruising
* loss of appetite
* liver damage
* flu-like symptoms
* lack of energy

Not to mention hyperglycemia and diabetes. And oh yeah, cataracts. They tried it for elderly people with behavioral problems from dementia, but it, uhh, killed them.

Then there are side effects called Neuroleptic Malignant Syndrome -- which is potentially fatal -- Tardive Dyskenesia, which is an irreversible movement disorder,

As the prescribing information says, "Chronic antipsychotic treatment should generally be reserved for patients who appear to suffer from a chronic illness that is 1) known to respond to antipsychotic drugs and 2) for whom equally effective, but potentially less harmful treatments are unavailable or inappropriate."

While it is questionable whether a diagnosis of bipolar disorder can even be made with any confidence in a 4 year old -- and it is certainly rare -- there are standard treatments which are much safer than Quetiapine, starting with the first-line treatment lithium. Some children are prescribed valproic acid (Depakote) and other anticonvulsants which have mood stabilizing effects. But medications are most effective if combined with psychosocial and behavioral therapy.

How this trial ever got approval is beyond me. No, I'm not a psychiatrist or an M.D. But I'm a citizen who also has a right to his views about whether the potential benefits justify the risks. (Thanks to ABC News for the tip-off.)

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