Hard Times in Toyland

No more pretend ECT for Barbie’s depression or antipsychotics for GI Joe’s PTSD — finally, the line of toys every budding psychiatrist has been waiting for — toys with specific mental illnesses already laid out from the German “asylum” that pumps them out.

These plush “patients” are the idea of Martin Kittsteiner from Hamburg, Germany. Each of the five toys from Paraplush has a specific psychiatric disorder presented in distinctly psychiatric terms on Paraplush’s online store — or as their website calls it, The Asylum: Psychiatric Clinic for Abused Cuddlytoys. Dub is a turtle suffering from depression, Dolly is a sheep suffering under the delusion that she’s a wolf and Kroko is battling paranoid psychosis and so on. Maybe the “asylum” can better relay the plight of these troubled toys. For example, Kroko, a crocodile:

The patient’s hypersensitive hallucinatory perception is a symptom of a paranoid psychosis. The signs are a mental block and a Gestaltzerfall (disintegration of structure) of the habitual field of experience. The consequence is a compensational reactivation of archaic reaction patterns.

The patient needs your help!

For the kid that just can’t help enough, they are available as a set — you know, for group therapy sessions.

The psychological dynamic of a group will challenge your analytic skills and leads to a complete new understanding of therapeutical treatment. Notice the relationships between different patients and discover the structure of a collective plush-subconscious.

Kittsteiner says of his creation,

“Children and grown ups like their vulnerability and find something in them that gives them a great sense of comfort in helping to heal them.”

Just like Cabbage Patch Kids come with adoption papers from Babyland General Hospital, these dolls are shipped out to your kids complete with medical histories and treatment plans. It is, after all, their new little owner’s job to  treat them — and really, who doesn’t like to revel in the vulnerability of the mentally ill?

It’s bizarre on so many levels and only becomes more so when you poke around on their website a little. There are illustrated posters detailing the theory of “plushtoy psychoanalysis” and treatment options and there’s even a game.

At least we can still count on Germany to offer up healthy approaches to mental hygiene.

Glaxo Testing Paxil on 7 Year Olds

Another Bnet link via Beyond Meds, an increasingly reliable pairing for getting me infuriated about the state of a pharmaceutical industry virtually devoid of ethics.

Glaxo is Testing Paxil on 7 Year Olds Dsepite Well Known Suicide Risks:

It was established years ago thatPaxil carries a risk of suicide in children and teens, butGlaxoSmithKline (GSK) has for the last 18 months been conducting a study of the antidepressant in kids as young as seven — in Japan…

The drug carries a “black box” warning on its patient information sheet, warning doctors and consumers that the antidepressant is twice as likely to generate lethal thoughts than a placebo…

Paxil is being tested against a placebo, so the results won’t be very surprising — even terrible drugs work better than sugar pills.

To what degree Paxil triggers suicide is only a secondary aim of the study. If the results suggest a lower suicide risk, expect GSK to play them up. If they’re bad, expect the company to dismiss them in favor of the primary endpoint results.

About 130 children have been enrolled, according to ClinicalTrials.gov, which puts about 65 patients in each arm. That means the results won’t be too statistically robust — there only need to be two or three outlier results to skew the numbers by several percentage points.

When do we reach the limit? When is enough enough? For all the talk of evidence based practice and apparently wiping out the need to scientifically determine things like the chemical imbalance these drugs are sold to “correct”,  how is it somehow not enough that real world evidence shows Paxil in particular and drugs like it have terrible outcomes in a lot of people and markedly more so in children? On top of that we have the studies showing that the only effects SSRIs are known to have in appreciably greater amounts than placebo are the negative effects. The kids have already been guinea pigs long enough for use to know the results are not good and certainly not controllable.

It’s gotten to the point that when you see a child in the news that kills himself strangely young and seemingly out of nowhere or shoots his classmates or kills his parents, you can all but assume that child is on antidepressants. Those are the increasingly predictable behaviors that have  earned this class of drugs their little black box. We need to realize that we are putting children on mind altering drugs and unless we know precisely how they work, we have no say over how these forming minds will be altered — here or in Japan.

Pfizer Overdosing Kids in Trials (Now Act Surprised)

Like all of the major pharmaceutical companies, Pfizer has a history of misconduct, corruption and deceipt but when is enough really enough? They were overdosing children on Geodon in clinical trials marked by almost every kind of failure and misstep. It’s okay though, they got…(gasp!)…a warning.

From Bnet:

Among those controversies: Discredited doctors allegedly prepared research on Geodon for the FDA; Pfizer allegedly promoted the drug for unapproved uses in kids; and the company allegedly paid a non-profit mental health advocacy group to promote Geodon for kids.

The FDA warned Pfizer that its trials of Geodon in children were improperly monitored, and that children got too much drug by mistake:

… dosing errors occurred and overdosing extended over several days for all seven pediatric subjects; in one case for as long as 22 days.

…a Pfizer internal document dated October 3, 2007 and entitled “Safety Information on Affected Subjects” refers to the overdosing of an additional six pediatric subjects in study (b)(4) at two different sites…

The kids suffered from nervous tics and a loss of control of their limbs, among other symptoms. Pfizer said it conducts tests globally according to the highest ethical and scientific standards:

HIghest ethical and scientific standards? I would love to know what passes for standards at Pfizer because from where I’m sitting, it’s hard to recognize any. They’re treating children like guinea pigs — and poorly treated ones at that.

Of course the company responded in the industry’s typical own-up-to-it-and-say-you’re-trying fashion with a letter that reads like the kind we were made to write as schoolchildren about how we understood it was wrong to disrupt the class or make messes.

Pfizer recognizes the seriousness of the issues cited by the FDA and is committed to fully addressing FDA’s concerns. Many of the items cited by the FDA were first uncovered and reported to the FDA by Pfizer as far back as four years ago as part of our ongoing clinical trial monitoring and quality assurance processes.  Since that time, Pfizer has instituted several new measures designed to improve monitoring and execution of clinical trials, including our oversight of clinical investigators.

Pfizer has communicated with the FDA about our conduct of clinical trials and, over the next two weeks, will provide an outline of new and existing processes for preventing similar issues with Pfizer clinical trials in the future.

It just sounds like more talk about writing up new policies of the type they’ve already proven to be capable of sticking to. I guess when it takes the FDA five years to get around to giving you a warning when you’re abusing children with drugs, the sense of urgency kind of goes out the window, doesn’t it?

If the dosing wasn’t enough, it would appear as though their application for Geodon use in children was “intentionally misleading regarding its cardiovascular effects.” On top of that they were accused by the DOJ of marketing off label (but then who doesn’t these days?) and stated in a DOJ statement:

The government alleges that Pfizer also promoted Geodon for use by unapproved patients, including pediatric and adolescent patients, and promoted Geodon for higher dosages than were approved by the FDA. This conduct included direct promotion by Pfizer sales representatives and promotion through the hiring of physicians, or “key opinion leaders”, to give promotional talks to other physicians about unapproved uses and dosages of Geodon. Specifically, these talks included encouraging doctors to prescribe the drug for children, and to prescribe the drug at substantially higher than approved dosages.

There is a lot of money in the sale of antipsychotics, particularly among children, a captive market that seldom has the option of saying no to the drugs. Pfizer pays a lot of money to doctors and other promotional outlets for one simple reason. They stand to make a lot more. They’re paying millions to make billions. Doctors selling other doctors on off label drugging and groups like NAMI promoting the notion to the patients for which they claim to advocate affords the company a kind of sales force that even the slickest of television and print ad campaigns can’t match.

One doctor was paid $4,000 a day to fly his private helicopter to meetings where he promoted Geodon off-label, according to a separate whistleblower suit, which Pfizer also settled.

And Pfizer allegedly gave more than $1.3 million in funds to the National Alliance for the Mentally Ill, a non-profit advocacy group, and hired the president of the organization as a paid speaker, according to another whistleblower suit. In an amazing coincidence, NAMI published a web page which advocated off-label use of Geodon in children.

So when is enough enough? if a company (really an industry) can lie about health risks, experiment on children, abandon ethical and scientific standards and engage in all manner of misconduct — what is too much? Why does it seem that all issues relating to pharmaceuticals and mental health seem to be relegated to smaller outlets of information and opinion put out by people who already have a position on one side or the other? Openly corrupt companies overdosing kids is not a special interest piece specific to mental health but a statement on our mistreatment of our nation’s youth regardless of the methods. I guess it’s easy to quell the outrage now that a warning from the FDA has set everything right again.

Kifuji on the Defense

The controversial Dr. Kifuji, prescribing psychiatrist for Rebecca Riley, appears to have evaded any criminal responsibility by exchanging her testimony for immunity. She is, however, up against a malpractice suit and some of the things that have come up are startling in terms of just how Rebecca’s very early death transpired and the role Kifuji played in all of it. I know I’ve brought up the doctor’s role in this before but every new fact that comes out is more frightening and infuriating than the last.

The Patriot Ledger ran an article that covers many of the almost too-bad-to-be-true circumstances that point to the fact that if Rebecca and Dr. Kifuji had never met, Rebecca might still be here. Regardless of your opinions on children and drugs, this case was wrong all around and the result of at least three people’s indefensible actions. Kifuji was more a drug dealer than a psychiatrist and while that’s not particularly uncommon, the young ages of her patients makes her a standout, even among the over-drugging crowd and the predictable end result in Rebecca’s case shows her to be  both reckless and ill qualified.

From the Patriot Ledger article:

Years before she became a board-certified psychiatrist, Dr. Kayoko Kifuji was diagnosing children as young as 2 as bipolar and hyperactive – and prescribing powerful cocktails of mood-altering drugs to quiet them.

By the time Kifuji finally passed the psychiatric board exam – on her fourth try – one of her youngest patients, Rebecca Riley, had a little more than a year to live.

The lack of involvement on Kifuji’s part was shocking. She saw Rebecca primarily for twenty minute sessions to adjust doses. Often she just used these sessions to put on paper her approval for the adjustments her mother was already making, having increased doses on her own and experimented with drug cocktails using drugs prescribed (also by Kifuji) to Rebecca’s siblings.

She relied almost exclusively on what Carolyn told her about the kids when diagnosing them and ordering increasing amounts of drugs for them.

Kifuji also trusted the mother to keep tabs on Rebecca’s heart rate and blood pressure for signs of problems with the four drugs she was on. Kifuji, a pediatrician who later became a psychiatrist, told Novotny during the deposition that she didn’t realize she had a blood pressure cuff in her office and could check the girl’s vital signs herself until after Rebecca was dead. She said she didn’t take Rebecca’s pulse with her fingers because Carolyn Riley told her the child’s pulse “was within normal range.”

Even a well intentioned mother shouldn’t be solely in charge of monitoring a child’s heart rate and blood pressure let alone a woman hell bent on gaining access to more and stronger drugs at the expense of her daughter’s health. Also, any pediatrician turned psychiatrist should think of performing such simple tasks as second nature. If not that, then what is a doctor for? How do you not even know you have basic medical equipment in your office? How does a doctor fail to check a child’s pulse? Oh, that’s right — her mother said. If that’s all there is to doctoring, it’s no wonder some might see her as just a drug dispenser. They can do the rest at home, it’s a mere technicality that you must be licensed to prescribe.

• Asked why she didn’t report Carolyn Riley to child welfare authorities after learning that the mother had increased the children’s doses at least twice without checking with her first, Kifuji said: “I just can’t report to the DSS. I need to … my role is to work with the parent and not judging them.”
• Asked if she ever told Carolyn not to give Rebecca cold medicine on top of all the drugs the child was on, Kifuji says no, “but it’s because Rebecca didn’t get sick, and I was never asked ”

Right — let a mother chemically abuse and experiment on a child but whatever you do, don’t judge and certainly don’t  give them any more information than they asked for. The article goes on to point out other times that Kifuji refilled prescriptions before they should have run out, never asking for an explanation, just dishing out more and more drugs.

She prescribed clonidine – the drug that killed Rebecca – during the child’s first visit to control the “impulsivity” that Carolyn Riley described. Rebecca was 2 at the time.

Impulsivity at two hardly makes a child a psychiatric oddity but when you look at some of her notes regarding Rebecca’s apparently troubling behavior it’s easy to get the notion that Kifuji sees childhood as a disorder unto itself.

“Then consistently hyper all the time. Climbs up to top of jungle gym without any fears and thinking. Gets into everything. Just walk up to someone and smack them. Never gets aggressive. Hits kicks and spits when she’s being disciplined and laughs. Started to say things scared her. Whines and fusses a lot.”

Kifuji described the toddler as dysarthric, meaning she could not properly pronounce some words.

“A bit tired since yesterday. Coming down on flu. Fine as long as she takes clonidine. Sleeps throughout. Without clonidine gets very hyper and impulsive.”

“Climbs up on top of bureau. Tantrums or sobbing when she was told to clean up her toys” and “she wasn’t listening to her mother.”

This child was drugged for one reason — she was stricken with a case of toddlerhood. Dr. Kifuji seems to see no distinction between behavior and disease. Now that psychiatry has largely gotten away from talk therapy, we’re supposed to see psychiatrists as doctors of the brain — linking behavior to dysfunction in the brain. If that’s the case, Kifuji doesn’t make it very well. She’s like a mad scientist but without the science.

She explained that some researchers believe the area of the brain called the amygdala is different in people with bipolar disease. But she admitted she didn’t know where the amygdala is in the brain.

Of course you don’t need to know the brain at all to dispense drugs in the manner that Kifuji had begun making a career of (there is a timeline of Rebecca’s “treatment” at the bottom of the article). You only need to know that if you sedate a child enough, you can drug the behavior out of them. Sure, that child may be a “floppy doll” sitting in the corner but a quiet floppy doll and certainly not disruptive and if enough people will pay you to drug the childhood out of their children to one extent or another, then you’re in business.

Yes, the parents physically gave the drugs to Rebecca but they were used as a weapon and that weapon was provided by Dr. Kifuji. If she had given them a blackjack instead and told them how many times you have to hit a kid for effective behavioral treatment, this would be a different case entirely. Our view of prescribed medicine as care makes us resistant to the notion that drugs can be poison but they clearly can be and often are, particularly with psych drugs. When this happens, we need to respond accordingly.

There are no less than three guilty parties here in a case of chemical assault that ended in a child’s death. It’s bad enough that Dr. Kifuji was granted immunity making it impossible to hold her criminally accountable, even as more facts come to light pointing to her role not in anything resembling care but in a death. If she is not held civilly and professionally accountable, we’re saying her actions are acceptable, even desirable and we’re signing off on a prescription for some seriously detrimental treatment. I’m relieved to see she’s at least going to be made to answer for her actions. She’s certainly got a lot to answer for in this suit. Now we’ll have to wait and see what passes as accountability these days.

Temple Grandin Speaks at TED

I watched this on Beyond Meds, a great blog and the product of a very valuable mind. Go there, catch up on the archives and check back often. It is a video of a speaking engagement at TED by Temple Grandin on valuing the diversity of minds and the real-world  usefulness of different types of thinkers. Grandin, diagnosed as autistic, has used her fixations and visual thinking in a great number of ways and her approach has lead to many children’s gifts being fostered instead of shrugged off as deviations. I had seen her on television years ago and not  heard anything since. It appears she’s been quite busy. Thank you, Gianna for posting this.

While I don’t think most would place me on the autism spectrum, I can relate to certain traits and perhaps more importantly to learning and thinking in a way that was not valued in my school years (for what it’s worth, I was labeled an ADD kid later into my schooling). There will always be a larger spectrum of human thought and experience and I will always wonder what things might have been like if there were a way for me to learn with my natural tendencies instead of in opposition to them. I am blessed to have found a career and a small group of peers that find value in the very traits that made me the subject of ridicule, separation and even physical restraint (another story for another time) in a broken school system.

If there are to be labels for children and the way they think, let them be used to offer more and better options and a greater understanding of their gifts, not to measure their distance from an imaginary center held as the ideal approach to learning and socializing. As it stands, normalcy is defined by a child’s adherence to a broken, outdated and narrowly focused system and virtually everything short of that is a disorder at worst and disruptive at best. If we begin to change our views and our establishments to suit the endless resource of young minds, everyone wins. If we stifle them to suit an old educational and social framework, everyone loses — everyone.

Jurors Speak Up with Hands Tied

In a break from the typical dismissive response to death by psych drugs, which is to assume everybody did their best and a bad but faultless thing happened, jurors in the Carolyn Riley case are outraged at the conduct of Dr. Kayoko Kifuji. Rightly so. Kifuji diagnosed children as mentally ill for exhibiting the defining behaviors of childhood. She Diagnosed a three year old child with pediatric bipolar disorder (which was absent from the DSM draft released the day after the conviction). She passed out cocktails of serious drugs to two year old children like they were Flintstone’s vitamins — drugs that aren’t approved for use in children and are usually used judiciously even in adults. She let the parents experiment on all of their kids with these drugs and, following their lead, prescribed per those experiments — so yes, the jury was outraged.

From the Boston Globe:

“Every one of us was very angry,’’ said one juror, who requested anonymity to avoid retaliation for her role in Tuesday’s second-degree murder conviction of Carolyn Riley. “Dr. Kifuji should be sitting in the defendant’s chair, too.’’

Another juror said that while the 12-member panel found that the 35-year-old mother was primarily responsible for Rebecca’s death, many jurors were “off the wall’’ when they heard the testimony of Dr. Kayoko Kifuji of Tufts Medical Center. She said they were struck by how quickly Kifuji diagnosed Rebecca with bipolar and hyperactivity disorders, as well as how little the doctor seemed to supervise the mother’s dispensing of medications.

“It blew me away,’’ said that juror, who asked to remain unidentified for fear of reprisals.

Rebecca’s psychiatrist was the focus of some of the most powerful reactions from the jurors after a three-week trial that left them emotionally and physically exhausted.

Not only has she not been convicted of a crime, she will go undisciplined by courts and the medical establishment even outside of the criminal trials surrounding the Rebecca Riley case which can only add to the frustrated outrage of the jurors.

Other than the nationwide publicity given to the Riley case, in which Kifuji is mentioned repeatedly, the only overt sign that Kifuji had potentially questionable conduct is on the Board of Registration of Medicine’s website…Still, when asked if the board’s investigation concluded that Kifuji acted within acceptable medical standards, spokesman Russell Aims responded by saying that the board “closed the complaint against Dr. Kifuji without discipline.’’ He said the board, however, “reserves the right to reopen a case if new information comes to light.’’

The psychiatrist will not face criminal prosecution. A grand jury last summer declined to indict her, and Kifuji testified in Carolyn Riley’s trial only after being granted immunity from prosecution.

Prosecutors contend the Rileys “duped” Kifuji into authorizing the drugs but that doesn’t say much for her as a doctor does it? “Duped” doesn’t begin to explain diagnosing toddlers as bipolar, her cavalier approach to diagnosing and prescribing in general or her indifference to the misuse of drugs like depakote and clonidine. Kifuji had access to Rebecca herself, providing ample opportunity to make her own assessments. She chose instead to go on the word of the parents in brief and drug centered visits. She admitted that she found the Rileys’ actions unsettling. Maybe they were just not unsettling enough to interfere with business. While the prosecution and Kifuji’s lawyers tried to paint her as the good and upstanding doctor who got fooled, in the end she comes out looking like the prime example of psychiatrist-as-drug-dealer — not unlike the physician in every town that addicts know to visit for his liberal dispensing of narcotics — and the Rileys were repeat business. If you’re going to hand out drugs that easily, without concern for how they’re being used and on whom, you don’t get to claim ignorance.

In a country where a gun manufacturer or salesperson can be held responsible for the crimes of someone who legally buys or even steals a handgun (which I’m against), it’s shocking that Kifuji is able to walk away from this without penalty. She is a doctor and with that paycheck and perceived authority comes an obligation to think past the drugs that keep you in business and consider the well being of the people in your care. I sincerely hope her other child patients fare better but it doesn’t seem likely. The only things that seem to have changed for Kifuji since Rebecca’s death are the amount of attention she’s received and a new sense of impunity.

Carolyn Riley Convicted

Well, the verdict is in. Carolyn Riley has been found guilty of second degree murder in the prescription drug induced death of her four year old daughter, Rebecca. I don’t know where to begin or what to say, really. We’re not talking about a child who had a freak reaction to a medication. Rebecca was a child abused with massive amounts of powerful drugs as a result of scheming parents and a negligent doctor and ultimately given an overdose of a sedative she never should have had. The Riley parents fabricated lists of symptoms for their children in order to get drugs to sedate them and when one of them, Rebecca, got pneumonia, they responded with more sedatives to quiet her complaints. When you have two parents who put all of their kids on heavy psych drugs at the age of two in order to control them, a doctor who sees diseases in the most basic childhood behaviors but not abuses when they are laid out in front of her and almost nobody paying attention, things turn horrible in no time at all — and that’s just the overview. The closer you look, the uglier it gets. I don’t even know how to approach some of the things that came to light during the trial but I have to wonder how many red flags have to be ignored before it all comes down to the death of a toddler diagnosed first as having attention deficit disorder, then at three, bipolar disorder — all for acting her age.

Boston Globe on the conviction: (emphasis mine)

A South Shore mother was found guilty today of second-degree murder in the death of her 4-year-old daughter who never woke up one night in December 2006 after ingesting toxic levels of psychotropic drugs…

The case had drawn national attention to the growing use of psychotropic drugs on very young children. When Rebecca died, she and her two older siblings were all on three potent psychiatric medications for bipolar and hyperactivity disorders. All of them went on those medications at age 2…

Prosecutors…depicted Carolyn Riley as an unusual type of child abuser, a woman who routinely overused sedating psychiatric pills to control her energetic toddlers and induce sleep. Prosecutors said she went to a lethal extreme in the hours before her daughter died on Dec. 13, 2006, dispensing as much as twice the girl’s daily dosage of clonidine at once as the girl was already battling a respiratory illness…

Prosecutors said the mother also had a scheme to obtain federal disablity checks through fraudulent claims that her children were mentally disabled…The state asserted that Carolyn Riley always put her husband’s needs over her children’s, and the night Rebecca received her fatal overdose, the husband was irate about the sick child’s repeated efforts to enter her parents’ bedroom, moaning, “Mommy … Mommy.”

and on the doctor: (who is still practicing and faced no charges)

Dr. Kayoko Kifuji acknowledged that when she first met Rebecca Riley, at age 2, she had initially diagnosed her with having attention-deficit hyperactivity disorder after only a one-hour meeting. She authorized the mother to give one prescription tablet of clonidine, a sedative, each night. But within a few days, Carolyn Riley acknowledged she was giving the girl two full tablets.

“Did she ask for you to authorize the double dose?” asked Plymouth First Assistant District Attorney Frank J. Middleton Jr.

“No,”

The relationship between Kifuji and Carolyn Riley was portrayed today as relatively minimal and business-like, resulting in the psychiatrist exhibiting a high degree of trust in the mother’s account of her children’s behavior, as well as a willingness to look past obvious transgressions committed by the mother in her dispensing of medication.

And what transgressions they were. While the whole situation speaks volumes about the Riley parents, Kifuji is no saint in all of this. Diagnosing toddlers as mentally ill and putting them on adult psychotropics is disturbing enough but to turn a blind eye to blatant chemical abuses against children is reprehensible. It could have all been over if she had put the brakes on then — but that’s not how she does things.

…the two met each other for the first time in April 2003 when Carolyn Riley brought her older daughter, Kaitlynne, then 2, to see Kifuji who was then practicing at a clinic a Bay State Medical Center in Springfield.

After a one-hour meeting in her office, the psychiatrist diagnosed Kaitlynne as having bipolar illness and immediately prescribed Depakote based largely on the mother’s depiction of the girl as physically aggressive to her older brother, and the girl saying she sometimes saw “monsters” and “ghosts.”

Over the next several months, as the mother reported Kaitlynne having continued problems, including sleep issues, the psychiatrist raised the possibility of adding clonidine. At that time, the mother acknowledged she had already been trying out clonidine on Kaitlynne, having taken some of these prescription pills from a bottle designated for her oldest son, Gerard.

“Did that concern you?” the prosecutor asked.

“Yes,” Kifuji replied.

While Kifuji told Carolyn Riley that a parent cannot just introduce new medications without a doctor’s approval, the psychiatrist went ahead and added clonidine to Kaitlynne’s regimen of prescription pills.

What more can I say? This child didn’t stand a chance. Her father, Michael (another saint) will be tried separately for the same charges.

FDA Warns Docs about Zyprexa

In news of the not-so-surprising, The LA Times reports that the FDA has issued a warning to doctors concerning increased metabolic risks in adolescents taking the drug olanzapine (Zyprexa). Risks include rapid weight gain and an increased likelihood of weight related physical concerns like diabetes and high cholesterol — serious problems that, you may remember, most doctors can’t be bothered to watch for. While this particular warning is limited to young people, you’ll find that the same risks are present in adults though it appears that adolescents are at a higher comparative risk. Interestingly, the warning applies only to those ages 13-17 being treated for diagnoses of schizophrenia and bipolar disorder, leaving out the growing number of even younger people for whom the drug is not approved but administered off label.

The agency has not approved the marketing of olanzapine — sold under the commercial name Zyprexa by the drug maker Eli Lilly — for use in children under 13 who are diagnosed with schizophrenia or bipolar disorder. But the medication, one of a class of psychiatric medications called the “atypical antipsychotics,” is widely prescribed for young patients, despite growing evidence that call its safety profile into question for this population.

The warning comes in the wake of the October publication in the Journal of the American Medical Assn., in which a study showed that children and adolescents taking their first-ever course of Zyprexa gained, on average, more than 17 pounds over a 12-week period, as well as dramatic increases in triglycerides and cholesterol levels — all factors that put them at higher risk of developing cardiovascular disease. While two other antipsychotic drugs — Seroquel and Risperdal — were implicated in significant weight gain and metabolic changes, Zyprexa was found to carry the highest risks of all three.

More than 17 pounds in 12 weeks? Whether a parent or a doctor, you wouldn’t think you’d need clinical trials and an FDA warning to notice such rapid weight gain in a kid. A pair of eyes and even vague concern should do the trick and while the primary problem is not cosmetic, rest assured — if you don’t notice the weight gain, the other kids will. So in addition to battling the middle school years with a psychiatric label, they can now do it overweight and worrying about their heart health and diabetes. That should do wonders for their emotional well being in the formative years. Actually, the LA Times erred on the conservative side in reporting those numbers. From the JAMA study that prompted the warning:

Patients taking their first-ever course of drugs marketed as Abilify, Risperdal, Seroquel and Zyprexa experienced weight gains ranging from about 9.7 pounds for Abilify to 18.7 pounds for Zyprexa. (Seroquel users gained about 13.2 pounds and Risperdal users gained about 11.7 pounds over 12 weeks. A comparison group of children with a diagnosis of severe mental illness but who were not on the medications gained less than a half-pound in the course of the study.)

With the youth market for antipsychotics constantly expanding and these drugs being approved or used off label for a range of behaviors broadening well into the mildest end of the spectrum (attention deficit, irritability), we need to be taking these risks seriously. The shift from using drugs as a last resort to using drugs as a means of grooming children for desirable behavior can’t be ignored in a discussion about antipsychotics in children and little good can come from making a child’s physical health take a back seat to a theory on mental illness. Do we really want to expose young people to greater risks of cardiovascular disease, diabetes and high cholesterol to “correct” moods and behaviors?

With the influx in young people on antipsychotics you might think this is the time to be looking into these problems but I think the time was fifteen years ago when Zyprexa was poised to enter the market. Now here we are repeating an often seen pattern — downplay risks for the duration of a drug’s patented life and spill it all at the end when its exclusivity is about to sunset — making the older, cheaper drug poor competition for its maker’s new and exclusive replacement. I wonder what the kids think about all of this. Something tells me no one’s really asking.