September 10, 2008Tell The FDA To Answer Questions About Pediatric Bipolar DisorderMany 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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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 PMI'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. I meant:.... FDA is done not only in ..... Posted by: Ana at September 10, 2008 01:03 PMThanks 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 PMHey 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 PMEmail sent. ;-) Posted by: susan at September 10, 2008 07:07 PMHard job. "Dear Mrs. Walsh. 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 AMOk 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 AMThis 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. 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 PMThoughts 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. Dan Abshear Post a comment
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