August 15, 2008FDA Psychiatry Chief Helped Pharma Design Trials For Pediatric Bipolar DisorderYesterday, I reported that the FDA's psychiatry products chief, Thomas Laughren, and the FDA itself were refusing to answer questions about pediatric bipolar disorder which the agency had two weeks previously determined unilaterally was a valid diagnosis. The FDA's move came despite much controversy in psychiatry about the disorder. Now, I can report that Laughren has a potentially huge conflict of interest and was deeply involved in helping "America's Pharmaceutical Research Companies" design clinical trials for the disorder. That would seem to be at-odds with his role as a federal regulator whom one would expect to be a disinterested, unconflicted reviewer of clinical trials submitted to the FDA. So far, the FDA has declined to comment on Laughren's role. In 2002, Laughren participated in a conference entitled "Methodological Issues and Controversies in Clinical Trials with Child and Adolescent Patients with Bipolar Disorder." The conference was held in the DC area and its proceedings were later published in the Journal of Child and Adolescent Psychopharmacology in 2003 (the paper is here). In the paper, it is noted that "Dr. Laughren is with the Food and Drug Administration, Rockville, Maryland. However, Dr. Laughren’s contribution to this article was made in his private capacity. No official support or endorsement by the Food and Drug Administration is intended or should be inferred." Why wouldn't it be inferred? Laughren attended and spoke at this conference sponsored by pharmaceutical companies helping a slew of researchers determine what pediatric bipolar disorder is, how it might be measured scientifically and how researchers and pharmaceutical companies might design and run clinical trials in order to get various drugs approved to treat the condition. Laughren attended the conference as a private person instead of as an FDA official, although he heads the FDA division that would later be responsible for reviewing clinical trials submitted by drug companies seeking to treat this newly-minted disorder. In the last year, the FDA approved two drugs for use in the disorder, Risperdal and Abilify, which are both atypical antipsychotics. In 2008, Laughren would claim that pediatric bipolar disorder is a valid disorder and then decline to specify what the disorder actually is. Laughren's participation in the conference strikes me as a conflict of interest and certainly is a telling indictation of how deeply entwined the relationship is between Big Pharma and the FDA when it comes both to drug approval and the creation of new disorders and new markets for the companies. John Grohol at Psych Central has already called this "diagnosis by government decree," since the disorder does not exist in the DSM and is not accepted as valid by many doctors as well as by private and public insurance programs. To be fair, I should note that there may be a perfectly good reason for Laughren's attendance at the conference. I can't guess at what that reason might be and that's why I contacted the FDA and Laughren seeking clarification of the reasons for Laughren's participation at the conference, but so far neither has responded to my request for comment. That said, it is difficult to imagine how it couldn't have been a conflict between Laughren's participation and his role as a federal regulator, especially once you take into account that the conference was underwritten by pharmaceutical companies. Listed as sponsors of the two-day event were Best Practice (a clinical trials consulting company) with financial support from the following companies: Abbott Pharmaceuticals, Bristol-Myers Squibb (makers of Abilify), GlaxoSmithKline, INC Research, Janssen Pharmaceutica, Johnson & Johnson Pharmaceutical Research and Development (J&J/Janssen makes Risperdal), Eli Lilly, Novartis, Pfizer, and Solvay Pharmaceuticals. What's more, several controversial child psychiatrists were part of the conference, including Melissa DelBello (who's been sharply criticized by Sen. Charles Grassley), Janet Wozniak (of the much maligned Biederman group at Harvard), David Shaffer (of Columbia University and the creator of the controversial Teen Screen) and others with deep ties to Big Pharma including Fred Goodwin ("The Infinite Mind" radio host and also a partner in conference sponsor Best Practice) and Joseph Calabrese (who's done many clinical trials of Seroquel in adults). In addition, representatives of three key advocacy groups also participated and one of them was credited as a co-author of the subsequent paper of the conference proceedings. That person was Martha Hellander, the then-executive director of the Child and Adolescent Bipolar Foundation. Also helping were Lydia Lewis, the then-executive director of the Depression and Bipolar Support Alliance and Darcy Gruttadaro, a lawyer identified as representing NAMI. All of these groups receive major funding from pharmaceutical companies and CABF in particular has been instrumental in helping the Biederman group at Harvard get the child bipolar business recognized in American medical circles. What precise contribution Laughren made to the conference is unclear, but it is apparent that he participated in a part of the conference devoted to identifying what types of persons should run clinical studies of treatments for child bipolar disorder, what measurement instruments should be used and what types of medical facilities should run the trials. Beyond that, his contribution is unclear except in one respect. There was some debate at the conference about how young patients should be who were to be included into the trials and how young a group it should be that pharma companies were seeking to get an FDA indication for. There was some discussion of this at the conference. "Representatives of regulatory agencies suggested that lowering the age limit to 7 or 8 years of age would oblige the sponsor to draw 40 percent of the sample from children 8 to 12 years of age." Translation: Some at the conference wanted to run clinical trials in kids under 10, but backed off once the FDA pointed out that they'd have to round up many kids 8 and 9 years old in order to have enough statistical power to create valid findings. So it's apparent that even though the FDA has now approved two drugs for pediatric bipolar disorder in children and teens aged 10 to 17 years old that pediatric bipolar disorder is essentially a proxy for much younger children. I want to be clear that a definition of mania and depression in young children was not hammered out at this conference, especially as relates to episode duration. Yet the FDA has now approved drugs for use in treating what it calls pediatric bipolar disorder, so the agency must have determined some kind of standard delineating what length of episodes count as mania and depression in kids. But the FDA has declined to answer questions about pediatric bipolar disorder and I can find no specific information on the FDA's website. What's more, the agency has not posted the approval packages for Risperdal and Abilify on its website, as required by law within 30 days of a drug's approval, so there isn't even a way to tell what the FDA considers the disorder to be from examining that data either. So we have a mystery diagnosis out there in America, folks. And, the FDA official in charge of passing judgment on the very drugs that youngsters will be given for the disorder was involved in telling pharmaceutical companies how to conduct their clinical trials for the disorder and later approved these drugs for use in children. Whose side is the FDA on? Posted by Philip Dawdy at August 15, 2008 09:16 AM
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The crime is rounding up children to be experimented on. Stop! Leave them alone! Ask them when they are 15,16,18, 20 if they cared to be drug experiments. These kids do not have informed consent. It is a violation of their bodies and minds to expose them to this especially while they are growing up. Just think of the class action lawsuits from all these wrongfully dxd and wrongfully poisoned kids as they start to roll in around 2018-2025. How much money is enough? Why can't people ever ever ever wake up before the tragedy instead of always after? Because we have cell phones that can make pancakes and we must get our work projects handed in on time. Also must see TV too. Think of all the disabled teens and adults who will live permanently reduced quality of life through suffering irreversible brain and CNS damage after years of unnecessary exposure to this garbage. Run those numbers through your accounting nerds. The FDA is a joke. The Biederman group is a fraud and a criminal enterprise. They are mad scientists. They are clearly not unbiased researchers. Have they been checked for mental problems? Narcissism, grandiosity, delusions of Godhood? If you are working with children shouldn't you have a conscious in your CV somewhere? How can you be such a qualified scientist and be so totally wrong? You folks know when the dust settles from all this bought and paid for researchers will be able to use the money they took to poison children in the name of bad science and hide from the worst it. Bierderman has a golden parachute. I am sure he can afford a second home, unlisted number and a car with tinted windows.
you go dawdy. keep writing. keep going. ..... Posted by: susan at August 15, 2008 10:45 AMJane, I doubt seriously that brain damage caused by these drugs will ever be viewed as brain damage - docs will just continue to blame it on the person's "mental illness." It is unbelievable that they can experiment on children like this, not to mention what they're doing with adults. Posted by: Lisa at August 15, 2008 10:58 AMI am seriously disturbed by this information. I really hope this developes into a full fledged scandal and it gets the attention it deserves. The FDA is waaaaay over stepping it's bounds, approving meds for a condition that isn't even agreed upon as existing in the medical community... and a condition which labels children in the worst way and the drugs that have been approved carrying one of the worst long term side effects of TD. So what if these kids are being miss-diagnosed and get TD from these drugs, then they are saddled for life with a disorder that marks them as mentaly ill wether they are or not? That's a horrible possibility that the FDA obviously is not concerned with. But then again, didn't the treatment for "restless legs syndrome" come to exist befor the actual diagnosis? Maybe this isn't as uncommon as it seems, the diagnosis being created by the FDA just to get a drug onto the market and into the bodies of people with a newly created diagnosis. It just seems worse when it comes to puttig what is considered a life long label on children and coercing them into taking meds that they may not need, so that *some* ignorant, lazy parents can have an easier time with thier kids. (And I am not refering to people who have tried other things than meds to help thier kids serious behavioral problems befor turning to meds, okay? It's not you folks with the seriously out of hand kids who are impossible to teach or discipline or love enough to get them to a point where they behave in a managable (safe) way... I am talking about anyone who takes thier kid to the psych doc as the sole means of managing any behavioral problems they have and accept medications as the first and only attempt to make hier kids "better".) I'm not saying there aren't *some* kids out there that have such huge behavioral problems and emotional problems behind them that they warrent this sort of strong medical regiment.... I just think it's becoming too easy. The more widely accepted something is, like a diagnosis, the easier it is to get hit with that label without OTHER OPTIONS being considered first. And it's even worse when there is no consensus as to how to diagnose something yet it's still being diagnosed in record numbers. I worry for those kids that do have parents that just want them to "be good kids" and see normal childhood behavior as a hassel and seek treatment to make a normaly hyperactive or pushy type child more docile... and I am sickened by any doctor who medicates an otherwise normal healthy kid just acting out in the same way any other normal healthy if somewhat difficult child would. ... but I know it happens. I just hope it doesn't happen as often as the darker part of my mind leads me to believe. I myself had childhood Bipolar, not type I but type II, so it was sort of easy to miss, at least by parents that weren't too concerned about what was going on with thier kids... and I am glad that I didn't get put on any meds as a kid. I could only immagine how much different I would be today, how much less insightful and less able to cope with life thru the usual means, releying on meds to solve every problem. I do wish I had gotten the right diagnosis when I was in my twenties and been put on the right sort of meds instead of getting a depression diagnosis and being put on Antidepressants and having those worsen my illness.... But I can not even fathom the notion that these strong medications I take now would have done anything but harm my developement as a child and teenager. I think people NEED thier childhoods in order to become whole in adulthood. If you take away a persons childhood by drugging them into oblivion, it's a very sick thing to do unless the only other option is that the child will continue doing things that are seriously dangerous and harmful to themselves and others. Dearest Philip: This is some great investigative reporting done here in this article from both yourself and Stephany over at http://bipolarsoupkitchen-stephany.blogspot.com/. It’s really unfortunate that the main stream media doesn't pick this story up; but then why would they? Big Pharma has them literally by the balls with their advertizing money and influence. Yours truly "diagnosis by government decree," This is a great expression that explains a lot. The same to Stephany: To all of you: you go. keep writing. keep going. .....
Nice reporting. Count me in as a contributor for your Fall donation drive with this story; I just hope it gets more exposure in other circles through your report if it is the main stimulus to the issue. Big pharma, will the evil ever end? Answer: NO! Not if people want quick fixes. Corruption. What a fucking concept! Posted by: therapyfirst at August 15, 2008 04:05 PMExcellent piece of investigative journalism on a tragic reality. I would imagine that the FDA is a revolving door for big pharma execs and their "med expert" shills. Posted by: Sally at August 15, 2008 04:31 PM"Diagnosis by government decree?" That's not really surprising, given the shoddy scientific underpinnings of psychiatry. A trade paper (Psychiatric Times or Clinical Psychiatry News, I forget which one) recently had an article that stated APA was convening a task force group meeting to "do away" with the diagnosis of schizoaffective disorder. I ask you: What other field of medicine can simply vote to do away with an "illness?" Can oncologists decide, by vote, that breast cancer doesn't exist? Can internists decide, again by roll call, that diabetes is history? Poof! Vanish into thin air, by a VOTE? Are you kidding me? So this government decree business about childhood bipolar should come as no surprise. Posted by: Patrick at August 15, 2008 05:53 PMThere is NO safeguard in the United States any longer to protect consumers from the pharmaceutical industry and KOL's(key opinion leaders;and the word 'opinion' should mean something here) influence. The fact that the FDA has agreed that pediatric bipolar disorder is "valid" just validates what we already know: 1.Harvard Mass is under Federal investigation for the millions of dollars 3 researchers (Joseph Biederman for one)somehow "forgot" to report they received from pharma. 2. Senator Grassley has asked the APA to open their accounting books. 3. Thoman Laughren is a ghostwriter. He has lent his name to several publications. The corruption reaches straight to the White House. As a matter of fact the U.S. Senate Sergeant at arms got to my blog via a name from "Best Practice". What has happened, is a crisis. Maybe McCain can understand what the word "crisis" means inside his own country, with regard to the pharmaceutical industry, and the drugging of innocent children. Or Obama can take his hand from the cookie jar. PARENTS : DON'T FALL FOR THIS TRAP. It's the same one that ruined my life and my daughter's a decade ago. Posted by: Stephany at August 15, 2008 09:16 PMAll of this makes me think there are some people in the FDA and pharmaceutical companies who might need medication and psychotherapy a lot more than I do. Posted by: Stormgazer at August 15, 2008 10:48 PMThey think that because mainstream media don't fully cover it public opinion is not aware or suspicious. Honestly, I don't see why it's not just a common sense position (rather than a "pro-medication" or "anti-medication" position) that medications affect children far differently than they do adults -- ANY medications -- and thus must be used much more judiciously and after testing done far more rigorously and far more ETHICALLY than is the case now. That's why learning recently that the young child of a friend of mine is taking Risperdal made me want to, well, vomit out my lithium. There's a universe of difference between an adult making informed consent and having understanding of potential side effects (e.g., lithium's nausea) and and a child doing so. Nor does it help that docs, aided and abetted by Big Pharma and the feds, obscure parents from being able to give truly informed consent for their children. ("Gee, she has been gaining quite a bit of weight lately" ... honestly, did anyone before me mention the word DIABETES to my friend?) And I won't even get into the morality of TESTING under these circumstances; suffice to say it's dubious at best and others have spoken to it far more eloquently. But common sense isn't very common sometimes, as we know. And the Bushies really put a fox in charge of that particular henhouse at the FDA, didn't they? (DISCLOSURE: I've been helped by DBSA local support groups. Yes, I know DBSA's headquarters gets money from pharmaceutical companies. Shouldn't be necessary to make such a statement, but maybe with stories like this I have to.) Posted by: Larry at August 16, 2008 08:12 AMIn 2002, Laughren participated in a conference entitled "Methodological Issues and Controversies in Clinical Trials with Child and Adolescent Patients with Bipolar Disorder." Controversies? In addition on the second day, a fifth workgroup met to enable representatives of the FDA as well as European and Canadian regulatory bodies to discuss recommendations.... Perhaps I have better swallowing my questions marks otherwise... Posted by: Ana at August 16, 2008 01:48 PM Comments from E. Fuller Torrey and John McManamy? Remember The Walrus and the Carpenter and the little oysters they strung along? "And answer came there none" - because they'd eaten every one. Posted by: Lilly NC at August 16, 2008 10:42 PMThis is my favorite blog ;) Posted by: kim at August 17, 2008 09:33 AMI'm deeply scared to say it but I'll say it anyway: I am going to ask something radical: why shouldn't regulatory agencies assist people who run clinical trials? Before running off with conspiracy theories (which may or may not be partially valid), think about it. The FDA has specific standards for what constitutes a clinical trial, and what constitutes appropriate results. I'm a little concerned that the company representatives who wanted to include children under 10 didn't first do a statistical power analysis, but at least someone reminded them about sample composition. As long as FDA officials are not promising free rides to companies who haven't yet begun their trials, and are not involved in the trials themselves, it may actually be a good thing for the FDA to offer more guidance on study design. This would cut down on the number of crappy trials the FDA would have to review and reject, and also potentially provide additional human-subjects protection if the FDA specifies minimum standards. And this is essentially what the IRB (institutional review board) does anyway, whether the trial occurs at a university or in a patient-care setting. Posted by: Gerbil at August 19, 2008 05:45 PMPost a comment
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