Thursday, July 31, 2008

FDA Gives Thumbs Up To Kiddie Bipolar: Is KOL Syndrome Next?

Philip Dawdy at Furious Seasons noted that the FDA has officially approved the existence of child bipolar disorder. Prior to it being included in the DSM, and with considerable controversy in the professional community, the FDA jumps on board. Nice. Thanks to Philip for chasing down the FDA's official view.

A few questions for consideration by the FDA (and others) that I mentioned a few months ago:

1. Does child bipolar really exist in substantial quantity?
2. Does treatment help kids with this "disorder"?
3. Why would a leading "expert" in child "bipolar disorder" say that up to 75% of children who are "bipolar" become suicidal without citing any supporting evidence?

Joe Biederman must be proud -- the FDA will now help him and his posse save countless lives through the administration of treatments (like, say, Seroquel) for "child bipolar" that lack any sort of substantive evidence base. But who cares -- even without professional consensus or any sort of official word from the FDA, the treatment of child bipolar has already flown the coop in a big way. Realistically, I suppose that the FDA's view is irrelevant -- drug marketers and key opinion leaders wield more influence than anyone at FDA when it comes to how physicians view psychiatric diagnoses.

KOL Syndrome: On a related note, perhaps the FDA (or the DSM-V committee) can approve KOL Syndrome as a disorder. That would be Key Opinion Leader Syndrome. For case examples, please see here, here, here, here, here, and here. The prevalence of KOL Syndrome seems to be increasing and seems related to the widespread adoption of irrational prescribing as well as information laundering. Symptoms include:
Back to kiddie bipolar: Do some adolescents have bipolar disorder? Sure. Five-year-olds? That's where I start getting suspicious...

Also see an excellent post from John Grohol at Psych Central on youth bipolar and some of the logical problems regarding how its treatment is advocated. And Furious Seasons also notes that the FDA database raises questions about two of the drugs touted as safe and effective for kiddie bipolar.


Anonymous said...

Of course treatment For KOL would consist of Zyprexa and Paxil. Paxil would need to be abruptly stopped every 12 months to get the full benefits of treatments.

Anonymous said...

I think Philip's post was about an op-ed in the Boston Globe by Biederman's henchwoman, Janet Wozniak. She implied in the piece that the FDA's approval of Abilify and Risperdal for Bipolar in kids somehow affirms the validity of the diagnosis -- which it obviously doesn't in any real way. They can barely keep the public safe from dangerous drugs -- they don't get involved in diagnostic nosology and research. She knows that too, but she wrote the letter and siad it anyway. By the way, her op-ed was a response to a damning article by a former professor of medicine and social medicine at Harvard published a few weeks earlier. Hell, the FDA can't even keep our produce safe.

Anonymous said...

Psychiatrists and drug companies are going even crazier. LEt's feed the kids with meds! I've linked to your site and written a few things myself if you want to check it out at

Anonymous said...

I'm really against children taking psychoactive drugs:

Misunderstandings and Popularity: SSRI/SNRI Anti-Depressants

Presently, for the treatment of depression and other what some claim are other types of mental disorders, as some claim certain mental disorders are somewhat questionable, selective serotonin reuptake inhibitors (SSRIs) are the drugs of choice by most prescribers today. Such meds, meds that affect the mind are called psychotropic medications. SSRIs also include a few meds in this class with the addition of a norepinephrine uptake inhibitor added to the SSRI, and these are referred to SNRI medications, which combined with SSRIs, are the number 1 top therapeutic class of prescriptions presently. While there are several available SSRIs presently, two SNRIs available are Cymbalta and Effexor. Some consider these classes of meds a next generation mood enhancer after the benzodiazepine hype decades ago, as there are similarities regarding their intake by others, yet the mechanisms of action are clearly different, but not their continued use by others. Furthermore, regarding SNRIs, adding the additional agent of norepinepherine is presumed to increase the effectiveness of SSRIs by some.
Some Definitions:
Serotonin is a neurotransmitter thought to be associated with mood. The hypothesis was first suggested in the mid 1960s that this neurotransmitter may play a role in moods and emotions in humans. Yet to this day, the serotonin correlation with such behavioral and mental conditions is only theoretical. In fact, the psychiatrist’s bible, which is known as the DSM, states that the definite etiology of depression remains a mystery and remains unknown with complete certainty. So a chemical imbalance in the brain is not proven to be the cause of mood disorders, it is only suspected as a result of limited scientific evidence. In fact, diagnosing mental diseases such as depression is based on subjective assessment only, as interpreted by the prescriber, so one could question the accuracy of such diagnoses.
Norepinepherine is a stress hormone, which many believe help those who have such mood disorders as depression. Basically, with the theory that by adding this hormone, the SSRI will be more efficacious for a patient prescribed such a med, as suggested earlier.
And depression is only one of those mood disorders that may exist in certain patients, yet possibly the most devastating one. An accurate diagnosis of these mood conditions lack complete accuracy, as they can only be defined conceptually, so the diagnosis or impression concluded by the patient’s doctor is dependent on subjective criteria, such as questionnaires and patient observation. A social patient history is uncertain and tricky as well, some have said. There is no objective diagnostic testing for depression. Yet the diagnosis of depression in patients has increased quite a bit over the past few decades. Also, few would argue that depression does not exist in other people to the degree that the affected patient believes their mental condition is presently. Yet, one may contemplate, actually how many people are really depressed? What is believed is that if one is disabled or impaired from a mental paradigm, treatment is necessary and appropriate with medication.
In Time magazine’s June 16th 2008 cover story, it was reported that the military personnel in the Iraq war are pounding down SSRIs often. Every time there is a new war, there is a new drug, it seems.
Several decades ago, less than 1 percent of the U.S. population were diagnosed with depression, some have said. Today, it is believed that about 10 percent of the total population in the United States have or have experienced depression at some time in their lives that may vary in severity and longevity. Why this great increase in the growth of this condition remains unknown and is subject to speculation.
What is known is that the psychiatry specialty is the one specialty most paid to by certain pharmaceutical companies for ultimately and eventual support of their psychotropic meds that they currently promote to these doctors, as this aspect of the pharmaceutical industry clearly desires market growth of these products.
Regardless, SSRIs and SRNIs are the preferred treatment methods if depression or other mood disorders are suspected by a health care provider. Yet these meds discussed clearly are not the only treatments, medicinally or otherwise, for depression and other related and suspected disease states.
Over 30 million scripts of these types of meds are written annually, and the franchise is around 20 billion dollars a year now, along with some of the meds costing over 3 dollars per tablet. There are about ten different SSRI/SRNI meds available, many of which are now generic, yet essentially, they appear to be similar in regards to their efficacy and adverse events. The newest one, a SNRI called Pristiq, was approved in 2008, and is believed to be launched as a treatment for menopause. The first one of these SSRI meds was Prozac, which was available in 1988, and the drug was greatly praised for its ability to transform the lives of those who consumed this medication in the years that followed. Some termed Prozac, ‘the happy pill’. In addition, as the years went by and more drugs in this class became available, Prozac was the one of preference for many doctors for children. A favorable book was published specifically regarding this medication soon after it became so popular with others.
Furthermore, these meds have received upon request of their manufacturers additional indications besides depression for some really questionable conditions, such as social phobia and premenstrual syndrome. With the latter, I find it hard to believe that a natural female experience can be considered a treatable disease. Social phobia is a personality trait, in my opinion, which has been called shyness or perhaps a term coined by Dr. Carl Jung, which is introversion, so this probably should not be labeled a treatable disease as well. There are other indications for certain behavioral manifestations as well with the different SSRIs or SRNIs. So the market continues to grow with these meds. Yet, it is believed that these meds are effective in only about half of those who take them, so they are not going to be beneficial for those suspected of having certain medical illnesses treated by such meds. The makers of such meds seemed to have created such conditions besides depression for additional utilization of these types of medications, which is a process known as disease mongering. Drug companies that make these medications are active and have been active in forming mutual relationships with related disease- specific support groups, such as providing financial support for screenings for the indicated conditions of their meds- which includes the screening of children and adolescents in particular, I understand. As a layperson, I consider such activities dangerous and inappropriate for several reasons.
Danger and concerns by others with these psychotropics primarily involves the adverse effects associated with these types of meds, which include suicidal thoughts and actions, violence, including acts of homicide, and aggression, among others, and the makers of such drugs are suspected to have known about these effects and did not share them with the public in a timely and critical manner. While most SSRIs and SNRIs are approved for use in adults only, prescribing these meds to children and adolescents has drawn the most attention and debate with others, such as those in the medical profession as well as citizen watchdog groups. The reasons for this attention are due to the potential off-label use of these meds in this population, yet what may be most shocking is the fact that some of the makers of these meds did not release clinical study information about the risks of suicide as well as the other adverse events related to such populations, including the decreased efficacy of SSRIs in general, which is believed to be less than 10 percent more effective than a placebo. Paxil caught the attention of the government regarding this issue of data suppression some time ago, this hiding such important information- Elliot Spitzer specifically was the catalyst for this awareness, as I recall. Furthermore, that drug is in the spotlight once again years later. Some believe the drug maker knew about possible risk to the youth as early as 1991.
And there are very serious questions about the use of SSRIs in children and adolescents regarding the possible damaging effects of these meds on them. For example, do the SSRIs correct or create brain states considered not within normal limits, which in effect could cause harm rather than benefit? Are adolescents really depressed, or just experiencing what was once considered normal teenage angst? Do SSRIs have an effect on the brain development and their identity of such young people? Do adolescents in particular become dangerous or bizarre due to SSRIs interfering with the myelination occurring within their still developing brains? No one seems to know the correct answer to such questions, yet the danger associated with the use of SSRIs does in fact exist. It is observed in some who take such meds, but not all who take these meds. Yet health care providers possibly should be much more aware of these possibilities, possibly, along with the black box warning now on SSRI prescribing information for the youth that has existed since 1994.
Finally, if SSRIs or SNRIs are discontinued by a patient without medical supervision, withdrawals are believed to be quite brutal, and may be a catalyst for suicide in itself, as not only are these meds habit forming, but discontinuing these meds abruptly, I understand, leaves the brain in a state of neurochemical instability, as the neurons are recalibrating upon discontinuation of the SSRI or SNRI that altered the brain of the consumer of this type of med. This occurs to some degree with any psychotropic med, yet the withdrawals can reach a state of danger for the victim in some classes of meds such as SSRIs and SNRIs, it is believed.
SSRIs and SRNIs have been claimed by doctors and patients to be extremely beneficial for the patient’s well -being regarding the patient’s mental issues where these types of meds are used, yet the risk factors associated with this class of medications may outweigh any perceived benefit for the patient taking such a drug. Before these medications mentioned were developed, doctors praised trycyclics, another class of anti-depressants, in a similar manner some time ago. Considering the lack of efficacy that has been demonstrated objectively with the newer psychotropics, along with the deadly adverse events with these SSRI and SSNI meds only recently brought to the attention of others, other treatment options should probably be considered, but that is up to the discretion of the prescriber.
It is my hope that such a prescriber rules out possible other etiologies for their patients’ mental conditions before they conclude that such a patient is suffering from true mental illness requiring the medications mentioned earlier, such as asking their patients about life stressors and other medications these patients have taken in the past, for example. Because at times, a doctor can in fact do harm without intent.
“I use to care, but now I take a pill for that.” --- Author unknown
Dan Abshear
Author’s note: What has been written is based upon information and belief