September 10, 2008

Tell The FDA To Answer Questions About Pediatric Bipolar Disorder

Many of you are aware that in late July the FDA announced, in response to an inquiry I made, that pediatric bipolar disorder was a valid diagnosis. This came despite the fact that the controversial disorder (sometimes known as child bipolar disorder or juvenile bipolar disorder) is not in the DSM, is not an accepted diagnosis by public and private insurers and is a matter of much debate among child psychiatrists. The alleged disorder has also gotten quite a bit of attention in the press and it's my understanding that a major publication will have an article on the bipolar child business in the next few days.

Some background.

Since July, I have repeatedly asked the FDA to make Thomas Laughren, chief of its psychiatry products division, available to explain what exactly the disorder is--its precise scientifically-developed symptomology and episode durations--since it was Laughren who decided the diagnosis is valid. The FDA declined to let me interview Laughren (odd since I've interviewed him before on other matters and odder still since he helped Big Pharma design trials for the alleged diagnosis) and has since refused to answer my repeated requests that the agency explain, verbally or in writing, how it defines pediatric bipolar disorder. You'd think it would be an easy thing for the agency to do since it has approved two drugs recently to treat the alleged condition (ones that have led to hundreds of adverse events reports in children) and you wouldn't be crazy to wonder that if they approve drugs for a condition, then the agency must know what the condition is and should, in its capacity as a public health agency, tell the public what's going on.

Yesterday, I made a final request for an explanation and got no reply. Apparently, the agency must assume that the public isn't very interested in this matter and that I am simply a wingnut blogger who can be easily ignored by the mighty FDA.

To help correct this misapprehension, I think the FDA needs to hear from all of you who read this post. It doesn't matter whether you are pro-meds, anti-meds, a true believer that kids are psychiatrically ill at birth or that they are victims of bad environments explained by other DSM diagnoses--we all have a stake in having the FDA explain what pediatric bipolar disorder is, how it's measured, what its symptoms are, what its episodic duration is and so on. Otherwise, we run the risk of what Psych Central has dubbed diagnosis by government decree. Since when has the government been in the business of dreaming up psychiatric diagnoses?

The public information officer for the FDA's psychiatry products division is Sandy Walsh. You can shoot her an email at sandy.walsh@fda.hhs.gov. Tell her that the agency needs to answer legitimate questions about the diagnosis. Be polite, please. And thanks for your help.

Perhaps, we can all get some answers.

Posted by Philip Dawdy at September 10, 2008 11:24 AM
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Comments

Philip, you rock! I'll send her a nice, polite email asking a couple of nice questions.

Posted by: Deborah at September 10, 2008 12:20 PM

I've just send an e-mail to Mrs. Walsh as a Brazilian citizen for what is regulated by FDA is not only in Brazil but in many other countries.
Thank you Philip for this opportunity.

Posted by: Ana at September 10, 2008 01:01 PM

I meant:.... FDA is done not only in .....

Posted by: Ana at September 10, 2008 01:03 PM

Thanks for a great post. I sent her an email as both a person with bipolar disorder and a nurse. I'd also like to invite you to my blog--I just recently did a rather serious meme on being bipolar (ten things on tuesday--the bipolar edition). Your blog is at the top of my reader list--thanks again.

Posted by: NurseExec at September 10, 2008 02:18 PM

Hey Philip,

I sent her an e-mail. I'd love to help in any way I can; please let me know if there is anyone I can e-mail/write to, in order to help the "cause".

Posted by: NAP at September 10, 2008 04:20 PM

Email sent. ;-)

Posted by: susan at September 10, 2008 07:07 PM

Hard job.
No money and little support from people.
It would make a lot of difference if Mrs Walsh received as much e-mails as possible.

"Dear Mrs. Walsh.
Please answer this request.
Thank you.
Sincerely yours,
..........."
What keeps you going Philip?

Posted by: Anonymous at September 11, 2008 06:50 AM

I'm impressed that you have interviewed Laughren or anyone at all for that matter. The only time I ever have is during a public hearing. All my numerous emails to them end in a thud of silence. However, I'm happy to try this one. She can add it to the pile. They are in an awkward position on multiple fronts on this issue, including off label use of atypicals for children with this ""diagnosis""

Posted by: Sorrowful at September 11, 2008 09:21 AM

Ok she will get my letter I sent directly to Thomas. She needs to hear from mothers who saw their children suffer due to being misdiagnosed with pediatric bipolar and brain damaged from the drugs as a result. Not to mention the shortended lifespan, the chemical changes to a growing childs body, permanent Polycystic Ovary Syndrome,loss of teen years and friends, not to mention a broken apart family and financial disaster.

AND THE SAME CRITERIA FOR DX IS WHAT IT WAS THEN IN 1999.

NO MORE EVIDENCE OF SAFETY AND EFFICACY OF THE MEDS, IN FACT THERE IS MORE EVIDENCE THAT THESE MEDS ARE DEADLY!!

They (the FDA) are riding the pharma-funded, Biederman influenced axis of evil.

Posted by: Stephany at September 11, 2008 11:48 AM

This is interesting. My daughter was hospitalized twice this year. She's only 12, although overly mature for her age and suffered a fair deal of trauma. While they did diagnose her with PTSD and a mood disorder, they said that they would suspect she could eventually be diagnosed with bipolar disorder, however, and i quote, "she's too young for that diagnosis at this point ... she's far too young for us to determine that, and we don't diagnosis children as bipolar until they continue to mature and symptoms become more consistent with the disease." So, apparently some doctors aren't in agreement with the FDA yet, as this was approximately a month ago.
I appreciate your blog. It's helped me understand a great deal. Thanks.

Posted by: dw at September 11, 2008 04:23 PM

My open letter to the FDA:

http://alchemicalmusings.org/2008/09/11/open-letter-to-the-fda/

I encourage you all to do the same. Why wait for the editor to publish your letter?

Philip - would you like to teach all of us amateur journalists how to file a FOIA?

Posted by: Jonah at September 11, 2008 09:34 PM

Thoughts About Bipolar Disorder

Bipolar Disorder (manic-depressive illness), if a disorder at all, has been defined as a major affective mood disorder in which one alternates between the mental states of deep and brutal depression and inflated elation- with the depressive episodes occurring more frequently. The disorder affects one’s cognition, emotions, perceptions, and behavior- along with psychosomatic presentations (such as pain with depressive episodes, for example). It is thought to be due to a physiological dysfunctional brain in one affected with bipolar disorder, yet the etiology remains entirely unknown. It is also believed that bipolar disorder presents itself when the affected one is between the ages of 15 and 25 years old. The disorder was entered in the psychiatrists’ bible, the DSM, in 1980. Also, bipolar disorder is thought to be correlated with creativity and accelerated growth of neurons if one is affected by it.
Research has determined that as many as 15 to over 30 percent of bipolar disorder patients commit suicide if they are untreated. Also, as many as half of those affected with bipolar disorder also have at times severe substance abuse issues along with this disorder as well. Bipolar patients are also often experiencing anxiety issues that vary, and are treated often as such. The disorder varies as far as severity goes- with some bipolar disorder patients being more affected than others. In fact, there are at least 6 classifications of bipolar disorder, according to the DSM. Bipolar patients are thought to be symptomatic half of their lives- with depressive episodes occurring more frequently than manic ones. When symptomatic, bipolar patients are thought to be rather disabled, according to some. As many as half of those suspected as having a bipolar disorder are thought to have at least one parent with some sort of mood disorder, which suggests a genetic predisposition to the disorder.
The diagnosis has become more frequent recently. In one decade, the assigned diagnosis of bipolar disorder rose from being about 25 per 100 thousand people to being 1000 per 100,000 people. Most diagnosed with bipolar disorder are not diagnosed based on solid, comprehensive, or psychiatric review that is often absent of valid or standard diagnostic methods. Some believe as many as 5 percent of the human population may be affected by bipolar disorder- which includes as many as 12 million people in the United States. A subjective questionnaire called the Mental Status Examination is often utilized when diagnosing one suspected has having bipolar disorder. Many believe the diagnosis has increased recently due to the progressive treatment options now available. It is an argument of increased awareness versus over-diagnosis.
Yet the diagnosis is vague, as children and adolescents are often absent in research with bipolar disorder. Many younger than 18 years of age are prescribed atypical anti-psychotics as first line treatment, which is largely not recommended as treatment options. In fact, close to half a million of those younger than 18 years of age are prescribed the atypical anti-psychotic Risperdal alone, it has been determined. The class of medications overall is thought to be prescribed to about 10 percent of those non-adults thought to have bipolar disorder.
While not recommended, one half of all those assessed as being bipolar are prescribed antidepressants, such as SSRIs, as first line treatment. It has been suggested that this class of drugs has decreased the risk of suicide attempts compared with other classes of antidepressants for close to 20 years. Yet tricyclic antidepressants have been determined to be efficacious in over half of those diagnosed with bipolar disorder- with a greater amount of research behind this class of drugs. Yet, entirely recognized treatments for bipolar disorder long term are lithium or lamictal- along with an anti-convulsant. Sugar intake is thought to vex the symptoms of one with a bipolar disorder as well.
Atypical anti-psychotics have been prescribed for bipolar disorder, which change some aspects of the brain, physiologically, as does the disease itself. In fact, one may argue the brain becomes more efficient due to both the disorder and the treatment with the atypical anti-psychotics. Yet many recommend the utilization of this class of drugs with bipolar disorder only if psychosis is present as well. As many as 15 percent of bipolar disorder patients diagnosed as such are prescribed an atypical presently. This class of medications may be particularly beneficial for those women who are diagnosed with bipolar disorder who are pregnant, however.
Lithium, which is essentially a very light metal with low density in which the salts are obtained for medicinal treatment, and an anti-convulsant are believed to be standard bipolar treatment, pharmacologically, studies have shown. This is due to Dr. John Cade and his examination with lithium and its benefits with those who have psychotic excitement close to 60 years ago. Lithium is believed to be both neuro-protective as well as having an anti-suicidal affect in those believed to be bipolar- and is viewed as a mainstay as far as treatment for bipolar goes with many who treat the disorder. Lithium is thought to regulate the calcium molecule in the brain, so this and valporate are historically the medicinal treatment options preferred for those with bipolar disorder.
Bipolar is difficult to detect, and is often diagnosed as major depression with many affected by this disorder. There is no objective criteria protocol available to utilize when assessing any patient believed to be suffering from any mental disorder. So such mental disorders that are diagnosed are ambiguous, yet that does not conclude that such disorders do not exist, such as the case with bipolar disorder.
Yet perhaps a health care provider should be very thorough and knowledgeable when assessing a patient believed to have a mental condition such as bipolar disorder,

Dan Abshear

Posted by: Dan at January 18, 2009 11:57 AM
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