September 16, 2008The FDA (Finally) Responds (Sort Of) To Questions About Pediatric Bipolar DisorderYesterday, just as I was about to fax the agency a FOIA request in response to the FDA's continued silence on defining pediatric bipolar disorder, I got an email from Sandy Walsh, a press officer at the agency, stating the following: "The FDA does accept the validity of pediatric bipolar disorder. The FDA agrees with peer-reviewed journal articles, academics and clinicians that say that pediatric bipolar disorder can occur in children and adolescents and is a serious, chronic illness which causes shifts in a person's mood, energy, and ability to function. That AACAP guideline is right here. I've been reading it and will comment on it later, since it's hardly what one might consider a DSM kind of definition of pediatric bipolar disorder. After almost two months of pushing the agency to define a disorder it accepts as valid in the face of controversy within (and without) child psychiatry, I don't know what finally pushed the FDA's button. But I'm sure that the emails many of you sent to the agency last week certainly helped. I thank you all for writing the agency and helping to force the issue. I'll have more on this later today. Posted by Philip Dawdy at September 16, 2008 12:03 AM
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The FDA has based their validity on approvals for Risperdal and Abilify and those approvals does not validate calling an illness or disorder "real" in my opinion. I feel it is wild loss of common sense, and the government should not base a dx that is NOT in the DSM for kids, on Biederman and Wozniak's trial for example, done on 5 yr olds in 1999 for Risperdal. I stand by my thoughts on this, that Laughren was influenced by a KOL and it's Biederman, and the rest that have led this dx down the path straight to the approval from the FDA they wanted for those drugs for kids. It is Thomas Laughren who was at a pharma-funded work study group with CABF (a highly influential parent of "bp kids" website, where ALL of the ppl ever mentioned sat or sit on the professional advisory committee there, and Laughren himself needs to respond, not some PR person. I ran across a memo he wrote in 2007 saying that Lilly provided enough good evidence to approve Zyprexa for teens with bipolar....again he is signing approval papers as if this dx exists. There's a reason it exists. Pharma-funded KOL leaders studies are why. I'm so glad he seems to have forgotten Zyprexa is fully loaded with lawsuits, has one of the worst histories of an antipsychotic on the market, Lilly HID data about the diabetes risk (that was hidden in those documents that could have prevented Ellen's son from dying and could have prevented my daughter from years of enormous weight gain and more at age 11). I find this deplorable. The FDA is worthless with regard to safety of children's health if for one minute they think recommending Abilify and Risperdal is good for children. Since when is treatment for bipolar disorder done with antipsychotics? even at the minimum, why are they not talking mood stabilizers? instead they are already buying into pharma's marketing plan of mainstreaming antipsychotics for general use. I saw what my daughter looked like on Risperdal in 1999 and so did her teachers at school, which prompted a meeting and exact words were "what the hell is wrong with her?" I look back at that 6th grade photo and am shocked at how drugged up she looked. I feel the FDA has made a grave error here, and parents will not know at all what they are doing by using FDA standard approved drugs and dx's. Imagine, 9 years ago I watched this all unfold and these drugs were not approved yet, and you know what people? they still are dangerous, life-altering, and damaging to a growing child's body and brain, and the FDA says they are safe based on NO EVIDENCE of long-term use in kids!! WTF! Posted by: Stephany at September 16, 2008 01:32 AMWell, you've got a bunch of highly-paid "experts," whose very position in society is dependent upon the existence of this, and other, mental disorders. You've got a whole industry, which makes a great deal (if not the majority), of its money from the "fact" that it has the most widely recognized (officially), therapy for this disorder. And you've got the fact that they've been saying this for a long time, irrespective of whether they've been saying it because they believed it to be true, or because they had an interest (financial or otherwise), in saying it. Now, you're Joe B.D Mann. You're feted by what passes in our age as some important people. You're telling the drug industry what it wants to hear, and you're being financially rewarded for it. Your entire reality is founded upon bipolar being real, and diagnosable, and then treatable with drugs. What if even one of those three things wasn't true? You'd be fucked, wouldn't you? Your expertise would be out of the window, along with any residual credibility. Small wonder, then, that everybody refuses to budge - they can't even acknowledge the merest possibility that they've got it wrong, because that would require that they scrutinize the very system that a lot of people are claiming has caused them more harm than good, in order to find out where they got it wrong, when the truth is, there are a lot of people making a lot of money out of the current system, wrong or right. Let's face it: there's not much motivation, there, for anybody to do anything but carry on - except those who aren't profiting, of course: they're highly motivated. Matt Posted by: Matthew Holford at September 16, 2008 03:50 AM"Understanding the effects of bipolar disorder early in life may lead to better treatments and improve long-term outcomes as children and adolescents become adults. Dear Mrs Walsh,
Hi Philip, For some reason, the Individual Story on the increase in antidepressant use among youth in 2004 will not open. I think I have it now. Try this. http://www.ssristories.com/show.php?item=2036 Posted by: Rosie C. at September 16, 2008 07:26 AM That meeting in 2004 almost didn't happen...because so many people had signed up and there was so much press, the FDA tried to make all of us draw straws as to who could speak. They failed. What I see from the FDA, in response to this pressure, is a classic cut-and-paste job. How pathetic. I suspect that the scientists within the FDA who know anything about this managed to steer clear rather than lie or fudge. As far as giving Zyprexa and other atypical antipsychotics to teens and children for this fake disorder, the plan has always been to push to high price atypicals. I doubt you could barely find a kid on lithium (not perfect but doesn't kill people and actually works a lot of the time) who has been given this label. It is the drug of choice for manic depression. But even with adults, especially those on Medicaid like my son was, the push has been and is to give the patented atypicals. Evidence that they work? What I read is that many parents take their kids off due to the side effects like milk coming from the breasts of boys. The FDA is a joke. Here's hoping that if we get Obama there'll be some changes made. It didn't used to be as gross as it is before Bush came in. Waxman has done studies to prove this...of course if one of your best friends is Syd Taurel of Lilly, as president you will go out of your way to favor this lethal industry. Posted by: Sorrowful at September 16, 2008 12:28 PMI too received this response from the FDA. It's discouraging and odd. Here's a bit I don't get:"Bipolar disorder is difficult to recognize and diagnose in youth, however, because it does not fit precisely the symptom criteria established for adults..." As others have noted, the very fact that by definition bipolar disorder in children is different from bipolar disorder in adults makes me wonder why it is being called bipolar disorder at all. Posted by: Sally at September 16, 2008 01:05 PM Sally wrote: I'll translate that for you: "Only very skilled people, such as Joe Beady-Mann, can possibly pick through the malaise, and identify the thing that is making one's child behave in a way that one (and possibly others), doesn't like. It's different to adult stuff, because we're dealing with kids, which just goes to show how complex this is, and how impressive we are for figuring it all out, and then making the difficult choice of which drug to prescribe. "You want to know how Jo Binderman does it, when the complexity of it all would cause any normal human mind to implode, and yet retain his sanity completely, despite the fact that he's delving into depths of human behaviour never plumbed, before? I'm afraid that can't be allowed, because Joe Boodlemon is incredibly important, and isn't able to sacrifice his valuable time for nobodies, not even his peers." Put another way: "we make the rules, and we're not letting on what the rules are, because if we did that, you'd be able to scrutinize us altogether more effectively." As an afterthought, what do you imagine it would be like, trying to gainsay Boodleman's paradigm? Imagine you found yourself on his team at Harvard, and you found fault with his approach? You'd be asked to make sure that the door didn't hit your arse, on the way out, probably. I reckon Bindermann's surrounded himself with clones of himself. Matt Posted by: Matthew Holford at September 16, 2008 03:47 PMPost a comment
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