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BLOG: September 2008

Who's the psycho?

Suited talk aside, a real-life consensus of the practicing medical professionals in the U.S. is that American children need two to three times more psychotropic (affecting brain) drugs than kids in Netherlands or Germany. More specifically, nearly two times higher prescription rate for antipsychotic drugs, and over three times for antidepressants and stimulants.

 That is what a recent study (Zito and al., Sept. 24 2008 online edition of Child and Adolescent Psychiatry and Mental Health) has found out. Are the U.S. kids genetically inferior, or there is something else at play here?

Of course, it is possible that the Europeans are under-prescribing the drugs, but it cannot be assumed. One of more realistic possible explanations may have something to do with a recent, unpublicized FDA shift toward mandatory screening of new and existing drugs for their possible psychiatric side effects.

It started unfolding four years ago, after the FDA-commissioned study (Posner et al., Columbia University) confirmed earlier finding  by FDA's own Dr. Martin Mosholder that antidepressants can cause children to become suicidal. Then the French obesity drug, rimonabant, was declined entry to the U.S. market because it couldn't hold the water under similar scrutiny. And it is just being joined by Merck's obesity drug, taranabant (apparently, the similarity with the French drug extends beyond their generic names).

But there is much longer history to it. As far back as 1990 and 1991, suicidal risk with Prozac was identified and reported (Teicher and King, for adults and children, respectively). Never mind; at the FDA Advisory board meeting in 1991, Laughren (director of the FDA Division of Psychiatric Products) and Leber (the head of the FDA) managed to get split vote in favor of "no credible evidence" that antidepressant drugs could cause suicidal behavior.

Much latter, during a 2004 Congressional hearing, it was established that Laughren's presentation to the FDA Advisory committee that year had withheld important data with respect to Dr. Mosholder's 2004 finding about the risk of suicidal behavior caused by antidepressants.

Whatever people may be saying about Laughren, no one can say that he is not consistent in protecting interests of the drug makers.

If it was so difficult to get someone's attention with serious psychological risks of psychotropic drugs, is it wonder that it did take so long for a thought that drugs not intended to affect brain, could do so nevertheless? Cynics might say that maybe doctors are not as smart as they are trying to portrait themselves, but the real cause is more likely in the FDA seriously lacking when it comes to user safety in the drug market, in general.

The reason, as pretty much everyone knows by now, is that the influence and money of pharmaceutical companies

have provided them with a special, preferential treatment.

As a result, user safety has taken, for decades, back seat to their profits.

That is, until the facts have started surfacing outside the well established Big Pharma-FDA happy relationship. With no choice left, the FDA officials now are asking drug manufacturers to include assessment of possible psychological effects - particularly suicidal thoughts - in their premarketing clinical trials for a variety of suspect drugs, including those for pain, hypertension, cholesterol, insomnia, and others.

As for potentially dangerous drugs already on the market, most of them will be tolerated, under the worn out formal excuse that "the benefits outweigh the danger".

What all this has to do with the rate of prescribing psychotropic drugs to U.S. children? Well, they may actually need them more - or, rather, they may indeed have more mental problems that their European counterparts. If the rate of prescription drug use is higher in the U.S. - as it is - and (no one knows exactly how) many of those drugs do cause psychological side effects - bingo! - there we have it: an expanded market for psychotropic drugs.

The fact is, some drugs are so notorious for causing psychological side effects, that they are routinely prescribed with the "appropriate" psychotropic "fix".

But this is not the whole story. As expected - considering that many medical practitioners literally profit from issuing prescriptions - some doctors are just happy handing them out. Children prescriptions for five newer antipsychotics doubled from 2003 to 2006, to 4.4 million. The five include Lilly’s Zyprexa, that has never been FDA approved for pediatric use.

In the same period, incidence rate for children mental problems - as you probably anticipate - hasn't changed significantly.

 Risperdal, which has been FDA approved for use with children, contains hormonally active agent that can cause early menstruation in girls, or breast growth in boys; needless to say, estrogen mimics have proven capacity to do much worse damage to one's health than that in the longer term.

Almost as you are reading this, a government-funded study (Lieberman et al.) has found out that the new class of schizophrenia drugs (atypical antipsychotics, including both Zyprexa and Risperdal) are no more effective than the older drugs. The other common similarity is in causing rapid onset of significant side effects - including discomfort, sleepiness, excessive weight gain, elevated blood lipids, Parkinson-like involuntary muscle movements, and others. Not seldom, participants using medications ended in a hospital with worsened condition. The extent of of adverse effects was so significant that

nearly 3 in 4 of 1,493 study participants stopped taking their drug

and/or discontinued participation before the study course (18 months) ended. More specifically, 64% quit Zyprexa, and at least 74% one of the other four.

In fact, this clearly documents that all these drugs are

far more efficient in causing side effects
than making the user feel better.

So what was the reason to bring on this "new class" of drugs? Maybe the fact that they are 3 to 10 times more expensive than the old ones, and rack in $10 billion a year in sales? Does all this money has something to do with the rate of children antipsychotic prescriptions doubled in just four years?

The final question is: who is the psycho here? The children popping all those psychotropic drugs, the manufacturers pushing it for profit, the officials placing their stump of approval on it, for a fee, the medical community taking their comfortable ride along (and their piece of the pie), or the rest of us, allowing this drug craziness to last by readily coughing out our dollars for the elusive, rosy promise of medication, again and again?

The answer seems to be obvious.