November 19, 2008FDA Panel Slams Antipsychotic Use In Kids, TeensAs I noted on Monday, an FDA committee of outside experts was set to review the use of the atypical antipsychotic Zyprexa in teens. The meeting, according to the New York Times, turned into quite the affair with doctors denouncing safety labeling for the Lilly drug and Risperdal, a similar J&J product, "saying that far more needed to be done to discourage the medicines’ growing use in children, particularly to treat conditions for which the medicines have not been approved." It's really heartening to hear this kind of talk from researchers on an FDA committee, since I've been making this same basic point on this site and in print for over three years (in adults and kids) and plenty of readers have attacked me as a loon. I assume they'll be warmer to the same criticism coming from researchers. Perhaps, they'll also stop calling me an anti-psychiatrist and Scientologist. Or is that what they are going to start calling members of the FDA panel? As I've noted before, a lot of this antipsychotic use in youngsters seems to be going on with ADHD, at times a proxy diagnosis for child bipolar disorder (which doesn't exist in the DSM or insurance codes and so ends up being officially coded as ADHD). "More than 389,000 children and teenagers were treated last year with Risperdal, one of five popular medicines known as atypical antipsychotics. Of those patients, 240,000 were 12 or younger, according to data presented to the committee. In many cases, the drug was prescribed to treat attention deficit disorders. I'd suggest they start by reaching out to their peers who give kids Risperdal, Zyprexa, Seroquel, Abilify and the whole shooting gallery of antipsychotics and ask them what the hell they are thinking and to justify taking these kinds of risks with kids (or adults, for that matter). In my opinion, this isn't so much a matter of a labeling issue with the FDA (the committee wants stronger label warnings, but there's good evidence that docs ignore these), as it is a medical culture issue and a problem with our broader culture. The problem with medical cultural is currently under investigation by the US Senate, including the roles of prominent psychiatric researchers at Harvard, Emory University, the University of Texas and the University of Cincinnati. Exhibit A when it comes to antipsychotic use in kids would be Joseph Biederman, a professor of psychiatry at Harvard and inventor of child bipolar disorder, who's been pimping for the use of these drugs in kids way beyond their approved indications for years. At the same time that he's barking for pharma companies, he's been taking NIH research money, possibly in violation of federal research rules. Meanwhile, the FDA this summer decided to declare pediatric bipolar disorder a valid diagnosis all on its own, one of the most bizarre moves I've ever seen at that agency. And for anyone who wants to argue that these drugs are actually OK and I am spreading misinformation about their use and how block-headed doctors are in prescribing them, read this: "From 1993 through the first three months of 2008, 1,207 children given Risperdal suffered serious problems, including 31 who died. Among the deaths was a 9-year-old with attention deficit problems who suffered a fatal stroke 12 days after starting therapy with Risperdal." I've also identified other deaths and serious problems with anti-psychotic use in kids and teens. "Dr. Dure said he was concerned that doctors often failed to recognize the movement disorders, including tardive dyskinesia and dystonia, that can result from using these medicines. That's some really interesting talk from Thomas Laughren, director of the FDA's psychiatry products division, who was in charge of deciding that pediatric bipolar disorder was valid and who, as it turned out, had been working hand-in-hand with some researchers (who of course run trials for Big Pharma) to develop clincial trials for pediatric bipolar disorder several years ago, while employed at the FDA. Laughren has refused to answer questions about pediatric bipolar disorder and his role in its development and the agency has ignored repeated requests for information about Laughren's participation in the same. As I did recently in regards to forced, involuntary ECT, if anyone wants to write something defending the use of antipsychotics in kids for non-psychotic disorders, send it to me and I'll post it. I'll be back later this morning with some thoughts on just how screwed up things are at the FDA. Posted by Philip Dawdy at November 19, 2008 12:03 AM
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Thanks for hitting the nail on the head! Posted by: Andy Behrman at November 18, 2008 11:41 PMAndy! I've missed you on the blogopshere! Seriously! Love to you, and your family. I hope your girls are well. And belated L'Shana Tova! Susan S. (P.S. you still owe me a shirt). P. P. S. Sorry for the thread jack Philip! 3 lashes with a wet noodle? Posted by: susan at November 19, 2008 01:05 AMPhilip- you wrote- "It's really heartening to hear this kind of talk from researchers on an FDA committee, since I've been making this same basic point on this site and in print for over three years (in adults and kids) and plenty of readers have attacked me as a loon. I assume they'll be warmer to the same criticism coming from researchers. Perhaps, they'll also stop calling me an anti-psychiatrist and Scientologist. Or is that what they are going to start calling members of the FDA panel?"
Hello Philip, I am new to your blog, and also newly diagnosed with bipolar II disorder. (I'm 38 yrs old)And obviously, was immediately urged by my therapist to go see the pill pushing psychiatrist. I found your blog whilst researching this mental illness, and while looking for a way to treat it without the use of drugs. I was just watching the "abilify" commercial on TV the other day, and I almost died a thousand deaths! Have you SEEN that? Anyhow, I'm glad to see you're here, fighting the good fight against the morons in charge of our well-being. I am curious if you have any information on treating bipolar without drugs? Please contact me! My blog: http://solaceinwonderland.blogspot.com Sincerely, Chelsea Posted by: chelsea at November 19, 2008 08:23 AMDear Philip: Only three years plus too late by the wondrous FDA; I guess they just write off all those kids that have lifelong disabilities or death from these drugs in the name of advancing science and psychiatry! I guess you could call this news? Good News! Nice article Philip! Yours Truly, Oh brother, if the FDA "can do little to fix the problem" then just what in heavens' name can they do?! What is their mandate, their mission? I guess I agree they do need some more authority to enforce laws and regulations that already exist, like requiring phase IV reviews after drugs are approved, but to hand it all back on the medical specialty boards is a laugh. Let's beef up and take seriously the MedWatch arm of the FDA for one thing. They need to be asking Congress for the means to get some clout behind the authority they are already supposed to have that has been completely castrated by big pharma and commercial interests. And, just as an aside, appointing Janet Woodcock as head of the FDA as it is rumored Obama may do, is not the way to move forward with these failures of regulatory authority. Posted by: Sara at November 19, 2008 08:46 AMOne concern I have yet to hear mentioned about these drugs in kids is their possible impact on fertility for young girls. They are known to cause hormonal problems, and in some adults (me included) wreak havoc with menstrual cycles. What happens when you start that cascade before puberty has even happened? Posted by: Tilting at Windmills at November 19, 2008 09:03 AMPhilp, I'm such a gloomy little Celt that my take is that the latter will happen. And look for the panel members to be replaced with more "congenial" types. OR...it's possible that political change really *is* in the wind. In my state the Board of Psychology traditionally did every thing they could to not deal with sexual abuse of patients by predatory psychologists. Until women Ph.D.s began to dominate the board. At that point this state no longer was a haven for abusers. Considering that patients sexually abused by their psychotherapists have an extremely high suicide rate, it was heartening to see some real change happen. Let's hope this happens with the FDA, that it becomes repopulated with administrators more in line with their currently frustrated panel. Totally OT, but good to get Off My Chest: I remember one woman calling me when I worked on a "tepid line" (we lacked funds for a real hot line). Her MD psychiatrist had not only sexually abused her, he'd convinced her to build her home a mile or two past his on his dead end road! After he got done trashing her (the usual end to these "relationships"), she was pinned to her house by agoraphobia induced by the fact she had to drive by her perpetrator's house to get a quart of milk. Alas, the Board of Medicine in our state is still controlled by people whose main interest is to protect their members, not the public, so there was no recourse for her. Have a great day. I wish you all non-Celtic psyches. And for anyone who wants to argue that these drugs are actually OK and I am spreading misinformation about their use and how block-headed doctors are in prescribing them, read this: "From 1993 through the first three months of 2008, 1,207 children given Risperdal suffered serious problems, including 31 who died. Among the deaths was a 9-year-old with attention deficit problems who suffered a fatal stroke 12 days after starting therapy with Risperdal." Yes, but that does not demonstrate that Risperdal did it. It's like the website http://www.ssristories.com/ that lists article after article of trouble people have gotten into that were also on an SSRI at the same time. It's idiotic; there is no proof of causation there. Posted by: A Believer at November 19, 2008 12:18 PMa believer, you are a dangerous fool. dawdy is right, you aren't and that settles it. Posted by: Jones at November 19, 2008 01:07 PMA Believer, A Believer, we actually are not asserting causation on the website www.ssristories.com, but if you choose to read those stories carefully keeping the known adverse effects of SSRIs in mind as you do, as well as the known narrative details of the people who often behave bizarrely and completely out of character, then I would say the circumstantial evidence of causation in many of the stories is quite strong and certainly at the very least merits further investigation. It also demonstrates that something is seriously amiss in clinical practice if drugs that are supposed to help in fact do nothing to stop patients from doing far worse acts than anything they ever did before "treatment." The website is a layman's attempt to do a little adverse event monitoring. No one else is doing it in any systematic fashion and there clearly is a lot of data out there that should be tracked -- and investigated. And how many unmedicated 9 year olds suffer fatal strokes? You have to be kidding if you don't think Risperdal led directly to this death, probably on top of stimulants and who knows what else -- the poor kid. Posted by: Sara at November 19, 2008 01:47 PMTo Believer, It is true that www.SSRIstories.com does not prove causation. For that matter, cigarette smoking does not cause lung cancer - and before everyone goes ballistic with that statement - let me add that smoking increases the risk of lung cancer but several juries, one in England, decided that smoking did not cause lung cancer. There was a strong correlation but not causation. The reason for this type of thinking is that there are 50 other factors that can cause lung cancer and 15% of the people who have never smoked or even been around cigarette smoke will die from lung cancer. So smoking increases the risk of lung cancer by about seven times but it is not the cause of lung cancer. Too many other factors have to come into play. Now would I recommend that people start smoking because of this statistic. Absolutely and positively not! Even in the famous Paxil trial of Tobin Vs. Glaxco where the jury decided that Paxil was the reason a man committing a murder-suicide, the jury decided that the Paxil was 80% responsible and the perp was 20% responsible. So the jury did not actually say that Paxil causes murder-suicides. The jury only said that Paxil increases the risk of murder-suicides. So www.SSRIstories.com has a good purpose. It shows how there is an increased risk of suicides, murder & mayhem while on SSRIs & SNRIs but it does not show causation. It does show, though, that for 2,700+ people, SSRIs & SNRIs did not have a calming, relaxing, happy effect on them. Posted by: Rosie at November 19, 2008 04:15 PM "Dr. Laughren of the F.D.A. said the agency could do little to fix the problem. Instead, he said, medical specialty societies must do a better job educating doctors about the drugs’ side effects." If the medical specialty societies and their officers are being supported by the drugs' makers, who will ensure that the doctors are educated properly about the drugs' side effects? Check out some of the continuing medical education (CME) activities offered by medical specialty societies [http://www.ama-assn.org/ama/pub/category/7634.html]. Important items to note when evaluating a CME are the speakers' disclosures of possible conflicts of interest, who is sponsoring the activity, and if the sponsor's product is the topic of the CME activity. The link for The American Academy of Pharmaceutical Physicians is a dead link. The organization has changed its name to the Academy of Pharmaceutical Physicians and Investigators [http://www.appinet.org/FunctionalMenuCategory/AboutAPPI/APPIHistory.aspx]. Standards for commercial support of CME can be found on AMA's Web site [http://www.ama-assn.org/ama/pub/category/20058.html]. If you see anything fishy, you may wish to contact the Accreditation Council for Continuing Medical Education. Posted by: Nancy Fruge at November 19, 2008 04:17 PMmaybe i should search this blog for all of my comments about this: it could be a book. antipsychotics ruined my daughter's young life, to hell with those researchers and FDA. Posted by: Stephany at November 19, 2008 04:29 PMAnd how many unmedicated 9 year olds suffer fatal strokes? You have to be kidding if you don't think Risperdal led directly to this death, probably on top of stimulants and who knows what else -- the poor kid. From Stroke in children: recognition, treatment, and future directions.: "The incidence of childhood ischemic stroke exceeds 3.3 in 100,000 children per year, more than double the estimates from past decades. The increased incidence reflects, in part, increased survival in previously fatal conditions predisposing to stroke, including congenital heart disease, sickle cell anemia, and leukemia. Risk factors for stroke are recognized in more than 75% of children. Common risk factors include congenital heart disease and sickle cell disease. Progressive arteriopathies, including vasculitis and moyamoya syndrome, are rare in children with stroke; however, transient arteriopathies including post-varicella angiopathy are increasingly recognized. Prothrombotic abnormalities are frequently present but of unclear significance. Adverse outcomes after childhood stroke, including death in 10%, recurrence in 20%, and neurologic deficits in two thirds of survivors could be reduced with available stroke treatments. Aggressive prehospital emergency care and transfer could improve access to hyperacute stroke therapies including tPA. Currently, the diagnosis is delayed by more than 24 hours from onset in most children. " Posted by: lkhllywd at November 19, 2008 05:51 PMOkay, maybe I stand corrected as far as unmedicated kids having strokes, but here's some info on Risperdal and the increased risk of stroke: "Johnson & Johnson on Thursday said it will soon send letters to thousands of US physicians advising them of possible increased risk of stroke among elderly patients taking its blockbuster antipsychotic drug Risperdal. Note that this comes from pediatric neurologist, i.e. a real doctor, not from a psychiatrist. Still it's movement in the right direction, though with all of the children being wasted by these drugs as I type, the movement is of course too slow. Posted by: Sally at November 19, 2008 07:48 PMme again: Risperdal was given to my daughter at age 11; she turned pale, sweating, eyes rolled upward and I thought, seriously, that she was dead. I had no idea what the drug was the doctor gave her. They switched it to Zyprexa. For the love of God, please write to the FDA and demand protection of these children. Risperdal and Abilify are FDA approved for kids now, and all I can say is it was not in 1999 when my daughter was 11 and she is alive, and I have but the Grace of God to thank for that. Posted by: Stephany at November 19, 2008 09:23 PMA Believer, we actually are not asserting causation on the website www.ssristories.com, but ... I would say the circumstantial evidence of causation in many of the stories is quite strong ... Now you're contradicting yourself. You are asserting causation without a bit of evidence. If these medications are so harmful then why did the FDA approve them? If it wasn't psychiatric medications then you would have just found some other cause to feel empowered. These medications saved my son's life. End of argument. Posted by: A Believer at November 20, 2008 11:56 AMOh dear, A Believer, you have a long way to go if you don't understand the process by which harmful medications are approved by the FDA. It's called overriding commercial interests and the corruption of the whole scientific process by big pharma, but if your son is doing well, I'm happy for you. I hope he can tell us that himself some day. Actually the reason I found this cause is because, unlike your story, the drugs killed my child so I don't actually think I just go out and look for any old cause to feel empowered. I actually am trying hard to sound a voice of caution and alarm in order to help others avoid this fate. Posted by: Sara at November 20, 2008 01:41 PMThis information needs to get to the new head of the House Oversight and Commerce Committee, Henry Waxman. And check AHRP.ORG yesterday for a list of the conficts of interest of Dr. Laughren. Many's the pubic hearing I've attended with Dr. Laughren sitting there bored out of his gourd, while those of us who lost our children poured our hearts about about one issue or another. The atypical antypsychotics need the SAME black box warning the SSRIs got for those age 0-24. Tell me what the difference is , really, in terms of outcome. Plus, one of many reasons for the flood of children and adolescents to the atypicals is is the SSRI black box warning. What is a psychiatrist to do if they can't push a pill? THAT is what Dr. Laughren can do. Write to CHANGE.GOV and comment about the FDA to Obama's team. Suggest that Dr. Laughren (and Dr. Temple) should be fired immediately. And recommend Dr. David Graham to run the FDA - and ethical whistleblower from within the agency who is passionate about drug safety. Can't hurt. Posted by: sorrowful at November 20, 2008 02:08 PMAnd while you're at it, everyone, go over and read my review of a conference on adverse psychiatric reactions to drugs at Beyond Meds. Thanks to Gianna for posting it! It will give you some idea of how things are going awry in our health care system. A believer: Quote: "These medications saved my son's life. End of argument." Isn't that just great that your son was saved by these magical pills as you refer to them; not that you give a flying F--- that's its killing and destroying countless other kids lives. Just consider for a moment that someday the long term effects of these drugs on your son may just come back to bite you in the Ass. And who do you think your son will blame at that point? A Believer of course! You are making no tangible arguments, or have you ever made one here! You are just one in a long line of complete and utter fools that will believe anything a Doctor, the bought and paid for FDA, or anything a Pharmaceutical Company prints out to shove down the general public's throat; and then becomes "A Believer". You know what? Scientology is recruiting for new members; why don't you try that and tell it how it works out for you too! When you have something that you think is really important to say next time! Keep it to yourself; because it's just the same old bullshit and lies repackaged that everyone has heard here a million times before from corrupt Doctors, skewed studies preformed and conducted at many "Screw You while taking the money and running" Universities nationwide, bad and limited clinical trials, the in bed with Big Phama FDA, and Big Pharmaceutical itself to top the rotten cake of atrocious behavior and conduct. So take your "end of argument" and place it where the sun doesn’t shine. Yours Truly, Hi. I am a practicing child and adolescent psychiatrist in Philadelphia. I am relieved to finally see some concern being raised about this issue. I have been considering leaving the field as it has become so difficult to practice in a culture where medication is so glorified. A typical referral for me in my practice (I still see the vulnerable, poor, inner city kids ) is a child who has been hosptialized and given about 3 different medications, including an atypical antipsychotic. I have to spend large amounts of time trying to take the child off all these meds. Many times the parents are shocked when I review the risks associated with the medications while others are pleased that their children are sedated, therfore less irritable and aggressive. It is always a difficult situation. Posted by: Dr. Vicki Martin at November 24, 2008 06:26 AMI lost my 12 year old daughter four years ago to the side effects from Risperdal and Zoloft. Have contacted over 15 attorneys and no one will take her case. Kayla was born with a heart condition and this is what the dr's have chalked her death up to and have swept her death under the carpet. I am at a loss what to do now. As far as I am concerned,the medical field has commited murder once again. Please, check out Kayla's memorial site at Virtual Memeorials and search for Kayla Weddle. God bless every parent who lost a child to Risperdal and other drugs. Posted by: leslie at April 1, 2009 02:59 PMGood for you Dr. Vicki, keep doing what you're doing! Isn't it odd how marginalized groups and the poor seem to have much higher incidences of supposedly biological psychiatric illness then the rich and affluent have. As for A believer my parents were lazy and ignorant like you and messed up my brain with psychiatric medications as a child. I hope some day your son will be able to turn around and give a big f you for what you've done to him as I've been able to do to my parents. Posted by: psychiatricvictim at January 7, 2010 11:37 PMPost a comment
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