Guest guest Posted May 15, 2006 Report Share Posted May 15, 2006 SSRI-Research@ Sun, 14 May 2006 19:07:57 -0400 [sSRI-Research] ABC News Home: Tots Used as Human Guinea Pigs? - Please post your comments ABC News Home Tots Used as Human Guinea Pigs? http://blogs.abcnews.com/theblotter/2006/05/tots_used_as_hu.html May 12, 2006 10:56 AM Joseph Rhee Reports: ABC News has learned that a Massachusetts hospital is currently recruiting pre-schoolers to test the safety and effectiveness of a powerful antipsychotic drug called Quetiapine. The study, conducted by the Department of Pediatric Psychopharmacology at Massachusetts General Hospital, is testing subjects from four to six years of age with Bipolar Disorder. An earlier Massachusetts General study of the antipsychotic drugs Risperidone and Olanzapine recruited children as young as three years old. These antipsychotic drugs are only approved for use by adults and are so toxic they carry a " black box warning. " The drugs have been found to cause diabetes; a life-threatening nervous system problem called Neuroleptic Malignant Syndrome; low blood pressure; and have also led to higher death rates in the elderly. Despite these serious potential side-effects, a patient recruitment video obtained by ABC News contains no mention of any of these risks. Vera Hassner Sharav of the Alliance for Human Research Protection said, " Antipsychotics were never approved for use in children whose developing brains and central nervous system may be irreversibly harmed. We believe that physicians who subject children to the toxic effects of these drugs...are practicing outside medically accepted standards. " A previous clinical trial of Olanzapine was conducted by UCLA in 1998 on five children, aged 6 to 11. The authors of the study said treatment was discontinued within the first six weeks " because of adverse effects or lack of clinically significant therapeutic response. " Sharav also said it's questionable whether or not three or four year-olds can be accurately diagnosed for Bipolar Disorder. According to a 1999 Surgeon General report, " The signs and symptoms of mental disorders are often also the characteristics of normal development. " The National Institute for Mental Health has concluded that " diagnostic uncertainty...surrounds most manifestations of psychopathology at such an early age. " Neither the hospital nor the lead investigator for the trials, Dr. Joseph Biederman, responded to our requests for a comment on the trials. Click here for information on the Massachusetts General clinical trial. Click for FDA Information Sheet on antipsychotic drugs. May 12, 2006 | Permalink User Comments This research is totally un ethical and is opening up themselves for future lawsuits. These people may be irreparably harmed. Their parents may give concent but when these children reach the age of majority they can sue because they never had a chance to say what they wanted. Where is the AMA ethics committee? Our congresmen worry about the rights of a woman wanting her husbands money even though there was a will indicating her rights. Our congressmen worry about baseball players using drugs. Where are our congressmen now?? Posted by: Jeanne | May 12, 2006 12:10:55 PM This is obsurd where are the law enforcement officals. Any parent who would FORCE there CHILD to participate is failing there duty to protect them. Booh to the rich drug company. Posted by: David, Missouri | May 12, 2006 12:15:19 PM I think this is a terrible practice. However, I blame the parents who are the ones signing consent forms for this study. Under no circumstances should you let your kids be guinnea pigs for any experiment. As partents, we are suppose to protect them no matter what their mental state. I think the only time you should experiment on a child is when you have exhausted all other treatments. Otherwise, stick to the basics. Posted by: Lavenia | May 12, 2006 12:29:15 PM I am astonished that they are not warning the parents of those children. I will be even more astonished if any parents actually offer up their beloved children as sacrificial lambs for the sake of testing a drug that 3 and 4 year olds will never need. Posted by: Lydia | May 12, 2006 12:43:17 PM Before one pill is administered in this testing program the would the doctors and yourself sign a $1,000,000 bond against any adverse effects? Posted by: James R. Taylor | May 12, 2006 12:56:32 PM This study being conducted on toddlers is unheard of. These children are too young to be diagnosed with being bipolar and using these children for the sake of a study on a drug that specifically states its negative effects is unethical. I wonder if these researchers conducting the study are educated in the APA policy on ethical policies and practices. Posted by: Mary | May 12, 2006 1:21:28 PM I think part of the question is: How did this proposal pass for NIH approval? Posted by: Shailesh | May 12, 2006 1:37:10 PM Since when are children of these ages diagnosed with Bipolar disorder? The administration of this drug to children of these ages is totally inappropriate. Posted by: Shannon | May 12, 2006 2:02:12 PM Did you consult with the Institutional Review Board at Mass General before writing this story? Any research involving human subjects must, by law, undergo extensive certification and approval by the Institutional Review Board of the host institution. I find it very difficult to believe that such a study would be underway without close scrutiny and careful consideration of costs and benefits. Further information in this report would enable realistic conclusions about the ethical validity or lack thereof of this study. Let us not jump to conclusions without complete information, however heinous the supposed behavior. Posted by: Kristina | May 12, 2006 2:16:36 PM " First do no harm. " This is the hypocratic oath that the physician takes when graduating from medical school. I do understand and appreciate the need for research; however, to conduct such research on young, vulnerable,developing brains; I feel that this is treading in dangerous territories. Seroquel is one of the newer anti-psychotic drugs, this drug has a very powerful effect on adults. I cannot begin to imagine what it is going to do to the minds of young children that are going into this study with a previously documented mental illness. Posted by: Cynthia | May 12, 2006 2:17:46 PM Would these soulless psycho's test the drug on themselves or their family??? Posted by: Voice of Reason | May 12, 2006 2:55:11 PM Parents who subject their children to this testing should be turned into child protective services! Posted by: alison | May 12, 2006 2:59:12 PM Wouldn't the FDA need to be contacted before this trial could begin due to the risks of the drug and the lack of evidence that the children would benefit? There is a risk/benefit ratio that should be maintained for all studies, especially those involving children. Also, if an Institutional Review Board (IRB) approved this study without first consulting the FDA, an in-depth review of the IRB should take place. Posted by: christine | May 12, 2006 3:29:48 PM So, what then do you all propose should happen to the hundreds of children already on other anti-psychotics that have the exact same risk profile? Secondly, when did spelling become a lost art? Posted by: Andy | May 12, 2006 4:16:04 PM The government is behind this one for sure.. No hospital in the united states is going to get away with something like this unless big brother stands to make alot of money from it.. Also I would like to see which children are being targeted.. is it the children with health insurance or the ones on assistance? This seems like a much bigger problem then what is being talked about. The parents are not to blame.. unless they are drug addicts or alcoholics looking for some cash.. Maybe the state should require a physical and mental screening of the immediate family members before anyone can be used as a test subject.. the kids may be showing signs of mental illness.. but maybe its a symptom of the parents illness. Posted by: Katherine | May 12, 2006 4:33:21 PM you didn't say that testing was actually being done. Posted by: skidog | May 12, 2006 4:59:22 PM Had you done just a little more research, you'd find that these medications are commonly prescribed to children with severe mental illness, despite the fact thorough clincial trials have not been completed. I think Biedermans' lab is attempting to evaluate such practice in a very controlled manner, so that we can have more reliable information on the efficacy of such practice. i've no doubt that all parents are presented with a full explanation of potential risks via an informed consent process prior to entering their children in to the study. you site one study on 5 kids, on a different drug, with a different population as evidence for your point of view. that's a very inadequate argument. this is irresponisible journalism, and you're misleading the public. Posted by: cindy | May 12, 2006 5:07:19 PM Unfortunatley, most people have no idea what it's like to be that parent of a young child with a mood disorder. Putting a child on an anti-psychotic drug is done as a last resort when all else fails. Most parents struggle with this decision and don't take it likely.. Posted by: Rosa | May 12, 2006 5:26:13 PM It would be interesting to see a copy of the parental consent forms for this study. I'll bet anything it omits specific adverse affects, while having a generalized " blanket " statement which absolves Massachusetts General Hospital of any responsibility for harming these children. And where is the Ethics Review Board in this case? How much will the study profit at the expense of these innocent children?Absolutely sickening! Studies like this need to be criminalized. Posted by: Mary | May 12, 2006 11:37:06 PM I agree with the comments above from Cindy, Kristina, and Rosa. You've written a sensationalized report, which fails to acknowledge the process involved in setting up clinical trials, the recognized protocol of using antipsychotics in children with certain severe behavioral disorders, and the reality faced by parents who have exhausted all other therapies. Mass. General is an excellent hospital. Its IRB is interdisciplinary, including hospital administrators, physicians from various specialties, nurses, psychologists, social workers, chaplains, and legal staff. Ethics are paramount in making decisions about trials using human subjects. All clinical trials must be approved by the NIH, as this one was. You did, after all, link to the NIH page describing it. Despite Ms. Sharav's implication to the contrary, Dr. Biederman is not a rogue, Mengele-like figure performing horrific experiments on " tots " . His clinical trials have been thoroughly vetted by one of the best hospitals in the world and by the NIH, and the inclusion and exclusion criteria are stringent. Further, Ms. Sharav is flat-out wrong in stating that the use of antipsychotics in children is " outside medically accepted standards " . On the NIH page at your link, one of the criteria for exclusion from the clinical trials is, " A non-responder or a history of intolerance to an adequate trial of Quetiapine (2 months or more at an adequate dose) as determined by the clinician. " Clearly, Dr. Biederman is not the first to use Quetiapine in children. His clinical trials are designed to collect adequate data to make its use safer. You've worded your article so it sounds as if the so-called " recruitment video " is distributed to the general public, luring hapless parents whose children's mood swings fall within the parameters of normal development, and that the video constitutes the full extent of information provided to them. If you believe that parents can blunder into these trials without adequate information, read the inclusion criteria more carefully. Any child diagnosed with Bipolar Disorder is already in the system, has an IEP and a team of doctors and therapists. No decision to participate in the clinical trials for Quetiapine would be made without the consensus of the team and before all other therapies were exhausted. I have friends whose ten-year-old son, R, has Fragile X Syndrome, Autism, and Bipolar Disorder. The additional diagnosis of BPD at age six was based on a family history and cyclical swings between manic and depressive states, rather than as responses to environmental stimuli. He has always been far larger and stronger than other children his age. At age four, he outweighed his eight-year-old sister by 35 pounds, and in one of his rages, he nearly killed her by pinning her to a sidewalk and slamming her head against the cement before their mother could pull him off. The family regularly had bruises, deep bites, and even fractures from trying to restrain R. Years of multiple therapies and medications in accordance with his IEP failed to diminish his aggression. As a last resort, he was prescribed Seroquel (Quetiapine), which is in fact a recognized protocol for treating aggression in children with Fragile X Syndrome: His aggression is now under control. As you'll read at the page above, however, it's precisely the kind of research being conducted by Dr. Biederman which is needed to determine its safety and efficacy over time. Parents whose children are as profoundly disabled as R have nothing to lose by placing them in these clinical trials, and much to gain for their own children and others in similar situations. Thirty years ago, these children would have been warehoused in state institutions, where they'd have been subjected to far larger, unmonitored doses of antipsychotics, and probably kept in restraints for most of their (shortened) lives. IEPs now give parents the tools and support needed to care for their children at home, but additional resources are needed to make a semblance of normal life possible for these families. At some point, that goal necessarily involves clinical trials with human subjects. If I were in Mass. General's and Dr. Biederman's position, I too would have refused to dignify the sensationalism of a report with the title, " Tots Used as Human Guinea Pigs? " -- especially one fueled by Ms. Sharav, who has a fondness for Nazi comparisons. Her statement on her website is rife with them. I suggest that you ask Dr. Tim Johnson to do a follow-up report, giving objective and accurate information. Since he's from the Boston area, he is no doubt familiar with Mass. General's record of ethical clinical trials. He might even get a response to a request for comment. Posted by: Anna | May 13, 2006 6:32:44 AM This is irresponsible journalism. I am appalled that it is coming from ABC a prestigious news channel. I suggest ABC should immediately acknowledge that this report is incomplete and irresponsible in World News and Good Morning America. ABC should ask Dr. Tim Johnson to get all the information and report it within a week out of respect for the parents, Dr. Joseph Biederman, the Hospital and the public. This is the only responsible action. This is not respectful journalism. This is worse than tabloid. I wonder if Journalist take the oath to be responsible, honest, respectful and thorough! Posted by: June | May 13, 2006 6:19:15 PM It is completely unethical to inflict psychiatric drugs on small children. I maintain that if psychiatry ceased to be recognised as a valid branch of medicine and was completely abolished, the financial savings from that alone would save our U.K. National Health Service and so much pointless misery and physical and mental destruction would be prevented. My autistic son was first given psychiatric drugs by a residential care home when he was in his twenties - not for medical reasons but as a form of social control to compensate for a shortage of skilled staff. As a result of the drugs his behaviour worsened suddenly, so the doses were increased. At that stage I wasn't even aware that he'd been drugged. He is now drug-dependent and probably always will be, as there is no easy way of coming off the drugs, especially when people have learning disability and autism and have been taking them for more than a few weeks. No wonder our National Health Service is on the point of collapse when it is causing patients to become needlessly dependent on drugs that were not essential in the first place. My son will always need much more intensive input from paid carers than he used to before he was drugged, and I have been unable to work for years as his needs became incredibly complex thanks entirely to the negative effects of psychiatric drug-dependency. Most of those poor children in the Massachusetts Hospital trials will gradually be abandoned by their parents and families because the effects of the drugs on top of their existing problems will make caring for them too distressing, wearing and hopeless. Most of the people in the psychiatric establishment where my son lives don't have visitors. Posted by: Patricia Kay | May 13, 2006 8:23:16 PM How many deaths will it take to ban atypical antipsychotics from children? The FDA knew for three years that the elderly with Alzheimer's and dementia were dying of strokes and heart attacks from the off label use of these drugs. Finally, three years later, their use was banned. Now, two million children are being given these drugs as an off label use. As usual, the FDA is silent because they want their friends in the pharmaceutical industry to make money. I am appalled that NIMH would approve these trials for " tots " . How about babies next? That will pretty much have used everybody up. Posted by: Barbara | May 13, 2006 8:29:56 PM In 2002, Japan and England required Eli Lilly to place prominent warnings on the worst of this class of drugs, Olanzapine or Zyprexa. They had seen the evidence in their countries: People had died or gotten diabetes. Yet the FDA refused to act, stating in newspaper articles that they were going to " study all the drugs " . During this period, between 2002 and 2004, people died and got diabetes from this drug. They are STILL getting diabetes, and some are STILL dying from this drug - and to a lesser extent, the other drug. It was not until 2004 that a warning was required on all the drugs, not just the worst (Zyprexa). Shall we place bets as to how many children will have to die before the drug is banned for them? These drugs are the " hot new thing " for medical schools to study - making grant money and " names " for the researchers. How have we stooped so low in this country that money trumps all? What happened to " Do no harm " and the Hippocratic oath? All sold down the river for the sake of greed and personal gain. My heart goes out to the innocent children, on trials and on these lethal drugs. Posted by: Margaret | May 13, 2006 9:07:21 PM The diagnosis of bipolar disorder in children is driven by the profit motive of the pharmaceutical industry and physicians who medicalize everything. The message given to puzzled parents of children who are behaviorally out of control is that their child has an " illness " . Parents, relieved to have an explanation, embrace it. I have a suggestion to all who believe their young children have a " bipolar disorder " . Look at what they've been eating for years. How many chemicals and how much sugar (all school food is loaded with these)is your child getting every day? How many servings of vegetables a day is your child eating? I'm not just throwing darts blindfolded here. I consult with parents whose are reluctant to put their newly diagnosed " bipolar " child on psychotropic drugs. In the ten years I've been doing this, not one child has failed to respond to dietary changes. Watch the video that explains how a school system changed the lives of their most troubled students by feeding them whole foods. Serve whole foods in the form of fresh meats, fresh vegetables, and whole grains. Throw away all your canned, packaged, and frozen food. Get rid of all the sugar, and chemical-laden junk food. Is it difficult? Sure it is, when you're not used to it. But your children are worth the initial difficulty. After a couple of weeks, it's actually quite simple. You have nothing to lose if you try it. But be honest with yourself and give it a sincere try. And remember, children will protest. But you're the parent, you're the one who is supposed to guide them. So, don't give in. They'll thank you for it when they grow up to be well-functioning adults. The child that is drugged today will be drugged the rest of his or her life. Shame on the medical profession for being so willing to blindly follow the lead of an industry that creates market niches, and in the process, destroys the brains of young children. Shame on them for their inability to recognize a child ravaged by a poor diet. Posted by: Catherine Creel | May 13, 2006 9:15:16 PM The use of these drugs on children is unconscionable. There are many other options for helping psychiatrically disabled children besides using these highly potent drugs. I wish more federal research dollars were going into non-drug therapies for kids who need extra support. Posted by: Leah | May 13, 2006 9:24:38 PM Anti-psychotics tested on toddlers?lers diagnosed " bipolar? " This is downright obscene! What drugs are the psychiatrists on, these days, to account for their deranged behavior? Parents should be told that psychiatry is *not* a science, that psychiatric drugs, doled out so liberally these days, have enough proven " side " effects [?] to damage people for life. The legal system must provide [and enforce] some kind of straight jacket to restrain drug companies and psychiatrists from abusing and disabling us and the next generations. Posted by: Dr. Viviane Lerner, Ph.D. | May 13, 2006 11:03:17 PM I just wanted to say that drugging these babies is just the beginning. Once started on these poisons the receptors are damaged and for each receptor many sprout out in place of the damage receptor. These babies are captured in the system for life. These babies will be in and out of institutions/facilities/prison and the families involved will live a never ending nightmare like thousands of others I know. Vera is great to expose this atrocity to the world. I am sick of seeing deformed, damaged humans who were given cocktails of toxic chemicals and locked up (some for years, some forever as they died locked up). Twitching, drooling, loss of bladder and bowels. This will be called " mental illness " not IATROGENIC TREATMENT! Posted by: Linda | May 13, 2006 11:11:52 PM Thanks so much for exposing this medical atrocity. These drugs are known to cause structural brain damage in ADULTS, that can be seen in CAT scans! Posted by: Cassandra | May 14, 2006 12:30:56 AM Some comments have argued that Mass. General Hospital is a great institution, so unethical research could not be going on there. I wish it were so. Check out the disastrous psychosurgical experiments of the team of William Sweet, chief neurosurgeon at Mass. General, Vernon Mark, and Frank Ervin, all three of whom were Harvard professors. Googoling " Mark Ervin Sweet " will take you to information on their infamous and sadistic experiments as Mass. General Hospital. Prestige is no garantor of probity. Often those at the top of the heap feel they have the greatest latitude to do as they please. Posted by: Ned | May 14, 2006 12:53:19 AM some comments indicate that some of the babies (and I use that term because thats basically what we are dealing with here) have run the gamut of psychotropic meds and nothing has worked and the reasoning is they have no other choice but to consider something like anti psychotics etc. I speak from personal experience when I offer the possibility that the drugs might be the problem. Posted by: Gerry Despres | May 14, 2006 1:19:46 AM Psychiatry has no insight into its own destructiveness. Tweaking brain chemicals in pursuit of behavior modification is like taking a soldering iron to a computer in order to reprogram it, based on the observation that computers run on electricity. It's scientifically unsupportable, and often leads to permanent brain damage, as happens with young rats fed ritalin, who become depressed as adults. Psychiatry and much of the rest of medicine seems to have adopted the EPA's chemical standards with respect to its own ignorance: innocent until proven guilty. This is not science. This is abuse. Children need protection from these people. Posted by: rich winkel/ | May 14, 2006 1:35:51 AM My God...this is like something from a horror movie!! NOOOO!!! We CANNOT allow them to turn TODDLERS into braindamaged, drug addicted, zombies for life! My 18 year old daughter committed suicide on Paxil when a state of akathisia was indiced BY the drug!! What chance does a baby have???? It is pure evil..The answer lies in the diet!!! If Lithium is used in BI-POLAR drugs to stabilize moods...clearly there is a mineral deficiency of the trace mineral Lithium!! CUT OUT THE RUBBISH!! Whole foods is all that is needed! Why no cure the problem at it's source??? WHY? NO BIG PHARMA PROFIT of course...Their greed and evil knows no limits!! Posted by: Steph Gatchell | May 14, 2006 5:03:38 AM And here'$ why Niederman ain't talking: Joseph Biederman, M.D., Chair Harvard Medical School and Massachusetts General Hospital, Boston Dr. Biederman has received research support from Shire Richwood, Eli Lilly, Wyeth, Pfizer, Cephalon, Novartis, Janssen, Noven Pharmaceutical, Stanley Foundation, the National Institute of Mental Health (NIMH), the National Institute of Child Health & Human Development, and the National Institute on Drug Abuse (NIDA); is a member of the speakers bureaus for GlaxoSmithKline, Eli Lilly, Pfizer, Novartis, Wyeth, Shire Richwood, ALZA, and Cephalon; and is a member of the advisory boards for Eli Lilly, Celltech, Shire Richwood, Novartis, Noven Pharmaceutical, ALZA, McNeil, and Cephalon. http://www.psychiatrist.com/pcc/visuals/pccvis2003-2/indexc.htm Posted by: Sheila | May 14, 2006 6:33:23 AM As a veteran admirer of the science of pharmaceutical companies but a critic of their marketing, I have been deeply shocked in the past two years by revelations of their rampant unethical greed -trial results suppressed, conclusions published that are contrary to the data of trials, lethal adverse side effects ignored, disease mongering and now child abuse. They deserve to lose all public trust. Strict state regulation must be imposed on them in the public interest. Posted by: Paul Flynn MP | May 14, 2006 7:39:56 AM Yes that is correct Paul - the problem is (as you know) that state regulators have so far failed to demonstrate that they can deal with these companies or with science. The corrupt, science-deprived and unscientific regulators (MHRA in your part of the world, FDA and others) are part of the problem. The solution has to lie with governments and the setting up of proper regulators. That will never happen without grass-roots action, or some very major drug disasters - the industry manipulation extends so far and the money in brown envelopes is pretty persuasive. Even when the procedures of science are completely corrupted (e.g the Blumsohn case here in the UK, the TGN trial disaster, VIOXX, SSRI trial cheating) the system just continues almost unscathed. No company executives are ever prosecuted, and the regulators are as slippery as eels. Helen Posted by: D.H Delaney-Cooper | May 14, 2006 8:28:11 AM To the person who said the drugs had been shown to cause permanent damage in adults (CAT scans), please elaborate. I can get no information from the doctors prescribing risperdal. Thanks. Posted by: eLIZABETH | May 14, 2006 9:13:41 AM Dangers of psychotropic drugs - Research site: ssri-research Posted by: Lynn Michaels | May 14, 2006 9:16:55 AM It took very little observation to realise how damaging psychiatric diagnoses and treatments are to the patients. (Drugs, ECT, etc) The history of psychiatry, up to the present, reads like a catalogue of torture. If I know this, the doctors involved know the potential for damage their treatments do. Any psychiatric drugs on a small child is at best, irresponsible. The drug companies and their puppets participating in these trials, are already familiar with these drugs involved, and know the risks. But whose children are these? Are they in the care of public institutions entrusted with their wellbeing? Are they from socially deprived backgrounds? So many people including former HIV trials have been carried out on children in care, or othr trials in desperately poor areas of the world. So much for medical ethics. Diet offers a great many answers in these situations. In UK, a chef on TV went into a school and disgraced the government on their low standards for children's school meals. Having introduced basic quality food, stopping some of the junk food vending machines, the teachers reported having more attentive classes, and of several children on ventilaters, only one needed that support after getting a healthier diet. The government had to give way and support better school meals with more government funding. Posted by: alex | May 14, 2006 9:27:38 AM Massachusetts General Hospital's Neurology Department are part sponsors of a public forum called BrainTalk Neurology Communities. I've been a member of BrainTalk Neurology Communities for several years. I have never had any problems with their Moderators before. When I tried to access BrainTalk Neurology Communities this morning a curt unsigned message appeared: " You have been banned for the following reason. Libelous scandal. Date the ban will be lifted: Never. " The message had the following url: http://brain.hastypastry.net/forums/ I assume that the reason for the ban is because I posted the link to this ABC News article and I said: (Extract from my message to BrainTalk Neurology Forums - now deleted by them): " As we know, BrainTalk is sponsored in part by the Massachusetts General Hospital's Department of Neurology. The motto of BrainTalk is " Community with Compassion. " I feel that this information is so shocking that we should all have a reply from John Lester, the Site Manager, about what Massachusetts General Hospital for Children and Harvard Medical School are up to. " (End of extract from my message to BrainTalk) I only posted to BrainTalk what was already in the public domain and I said nothing libellous. I only asked for people's comments. Instead of replying to my query and putting my mind at rest, the regulators of BrainTalk decided to ban me from life from their web forums. Has anyone else had a similar experience when asking for further information about this news item? Posted by: Patricia Kay | May 14, 2006 9:51:18 AM If you've never attempted to raise a child who suffers from bipolar disorder and have never been forced to witness the devastating effects of this mental illness on the self-esteem of your own child, I think you should keep your negative comments to yourself. Bipolar disorder is hereditary and does exist in children from birth. It doesn't just appear out of the clear blue sky. The appropriate mood stabilizing medication, judiciously prescribed by a reputable child psychiatrist, has literally saved my child's life. Posted by: Jan | May 14, 2006 9:54:47 AM This is one of the most shocking violations of research ethics that I have ever seen. And from Mass. General Hospital! First, how can you possibly diagnose pre-schoolers with bipolar disorder? Second, who funded this study--the drug companies? How could they, in good conscience, do a study on an off-label use of a drug? An anti-psychotic for pre-schoolers is an oxymoron. Third, did anyone try to put the brakes on? Whatever happened to the part of the hospital that oversees consent? To the researchers' ethics? To the people who worked on the study in other capacities? Fourth, this calls the ethics of the very famous principal investigator, Dr. Joseph Biederman, into question. His license to practice should be suspended, and his ability to do research should be stopped. Posted by: Molly Hauck, Ph.D. | May 14, 2006 10:01:34 AM On its face, I would have qualms about giving antipsychotic drugs to children so young. I'm disappointed in ABC News, though, for using Vera Hassner Sharav as its sole source for this report. Sharav has a reputation for aggressively condemning the entire field of psychiatry, all psychiatric drugs, all pharmaceutical companies, and clinical trials using human subjects. On this subject, her views and those of Scientology seem to be identical. She even condemned voluntary screening in public schools for teens at risk of suicide: http://www.philly.com/mld/inquirer/living/education/13825281.htm A more responsible approach might be to present the views of a couple of people knowledgeable in the field and who don't have a dog in this fight, rather than only the views of someone whose opinion is part of a broader agenda aimed at discrediting the entire psychiatric profession. If Tom Cruise had sent you the video and the same information, would you have run with the report based on his " expertise " alone, or would you have taken the information to objective experts, instead? Where are the voices of your excellent science and health reporters? The following might be reasonable analogies: Fred Phelps sending the results of a study showing male-to-male transmission of HIV through kissing alone; Phyllis Schaffly raising an alarm about a high risk of death from abortifacient birth control pills; Warren Jeffs presenting data showing that women in monogamous marriages are at higher risk of uterine cancer than women in polygamous marriages. Wouldn't the obvious, larger agendas of these individuals lead you to investigate their claims through independent researchers? Finally, on an unrelated note, it's disturbing to see Sharav's proponents stigmatizing the parents of special needs kids for the agonizing decision to medicate them when needed. Their lives are difficult enough without giving a forum to people who call them abusers. We should all be better than that. Posted by: Jill Nikolaides | May 14, 2006 10:08:50 AM Kudos to ABC News for exposing this one aspect of the psychaitric fraud being perpetrated on all Americans. Without science, without results, but highly paid, how long before Americans wake up to the scam? This ABC NEws coverage has helped wake the sleeping giant! Thank you. Posted by: Steven Ferry | May 14, 2006 10:10:38 AM I feel it necessary to write in support of Ms Sharav, she is doing an excellent job for the public in raising essential awareness the practices of drug research, the need for more warnings by drug manufactureres, etc. and more general awareness amongst the public of these important issues. We need more campaigners just like her and in all sorts of fields which affect the public at large. An earlier poster began to refer to Scientology, a particular neurosis of the psychiatry profession. If critical and so concerning statements are backed up, it can come from the man in the moon, or Scientology, or Ms Sharav ... from here, they seem to be doing an excellent job for which thanks are due. I hope the children are spared from the sort of research this topic is about. Posted by: alex | May 14, 2006 10:43:44 AM Tragic. I routinely see adults misdiagnosed with psychiatry's diagnosis de jour, Bipolar disorder. A number of these adults would be able to manage their " illness " with stress reduction and life management strategies, but have instead been frightened into the chronic use of medicaments. It's difficult to countenance preemptive pediatric psychopharmacology when the target seems so elusive and poorly defined in adults. Posted by: William Danton | May 14, 2006 10:46:33 AM The saddest aspect of all of this charade of mental illness,is when challenged to produce viable,factual proof of chemical imbalances....They can't! Why.? I understand that the American Psychiatric (Pharmacuetical..?)Association,was recently challenged to open public debate by the American Academy of Science,and to bring with their conclusive proof of their claims to pumping kids full of pills due to all the undiagnosed mental illness our nation suffers from... Believe the only mental illness we are suffering from is, " Gullibility " Because we keep buying into all this " Theorized " trash thats gets passed off as bonafide science. If they want lab rats,let them take their own pills first..They after all should be the experts in the field of adverse side effects,and would know them first hand when they themselves would experience them.... Posted by: David | May 14, 2006 10:50:51 AM Psychiatry began drugging my brother when he was a teenager. The devastating physiological and cognitive effects of his medications destroyed his health and his future. He spent the next 40+ years in and out of a mental institution, attempting suicide twice (on his medications). After one suicide attempt he had to be taken off medications because of the severity of his injuries. He miraculously recovered---and returned to normal function. However, psychiatry diagnosed his suicide attempt as another symptom of mental illness and court ordered him back on the drugs. He again returned to his dysfunctional, zombie-like state. Suicide ideation is one of the many adverse effects of psychiatric medications. How absurd can it get. Although I have been able to prove my brother's problems stem from hypoglycemia and the exacerbating effects of alcohol, caffeine or sugar (and his medications) on his blood sugar and hormonal balance, the psychiatrists have resisted and attacked that reality (including going after my license to practice---I'm a dietitian) while giving him daily doses of caffeine in the institution--and then drugging him with Thorazine when he would have panic or anxiety attacks from the caffeine's adrenaline effects. Any mental, emotional or behavioral problem has one (or more) physical cause(s) that need to be addressed---and it is not a psychiatric drug deficiency problem. The drugs, in fact, CAUSE a multitude of mental, emotional and physical effects---documented in the PDR (Phisicians' Desk Ref.). However, today, psychiatry, the pharmaceutical industry, and the school systems profit by diagnosing children as disturbed when they simply eat poor diets, lack sufficient sleep, or are stressed or bored at home or school. It is inhumane to misdiagnose and then mistreat anyone with potentially life-threatening drugs that alter body and brain function. With drug companies funding medical schools and lobbying Congress, our doctors and politicians are becoming less educated and more indoctrinated. To protect our children we need more education---not medication. Don't let the drug companies and psychiatry destroy your child--like they did my brother. Mainstream psychiatry needlessly put my brother through a lifetime of mental, emotional and physical hell. They robbed him of his dignity, his potential to grow, his health, and his life. Stand up and fight like hell! Posted by: Georgia Janisch | May 14, 2006 11:40:55 AM I can't say this truly shocks me, with all the other unethical things going on in the world of psychiatry. I have even heard of people trying to administer Ritalin to pregnant women whose babies " kick too much, " assuming it will prevent the baby from getting ADHD. This type of experimentation has to be stopped. If adults want to subject themselves to dangerous antipsychotic drugs, let them volunteer for the studies. These drugs are so toxic that they should NEVER be administered to someone who is too young to make their own decisions. I cannot imagine a situation where I would subject my child (or anyone else) to this sort of abuse. The health consequences of these drugs are tremendous. The emotional consequences of being labelled, drugged, confused & identity and self-worth lost through the whole process are too great to force upon a baby, toddler, older child, or even an overly-trusting adult. Posted by: Amy Philo | May 14, 2006 11:41:33 AM Brian Ross! When you approved this report, did you intend to endorse the ENTIRE agenda of Sharav and her footsoldiers pouring onto this blog? Did you INTEND to associate yourself and ABC News with the crowd who say mental illness is a myth and psychiatrists are all evil? Without any follow-up from you, it looks like you want to push the mentally ill back into the shadows. Would you please make a statement about ABC's stand on mental illness? Posted by: Paul D | May 14, 2006 12:07:03 PM Psychiatry is only the tip off the iceberg. There is no science behind DSMIV. JAMA's editor published that 20% of all diagnosis at death were wrong. This statistic goes back to the 1930s. Medical schools need to be teaching about the 63 metals on the Periodic Table of Elements. That is about 2/3s of the known matter in the universe. If one were to look at western diagnostic panels you will see that over 2/3 do not assay metals. Do you think anybody in the $32 Trillion a year in total global medical burden wants to shrink that number? Hell no it is bad for business. Posted by: Mike Rupp | May 14, 2006 1:16:07 PM " Paul D " wants to equate skepticism of psychiatric " science " with trying to " push the mentally ill back into the shadows " . Next he'll be calling us all scientologists. The shadows are precisely where many psychiatrically drugged people live. One need only interview a few " consumers " of these brain damaging and life diminishing chemicals to put the lie to the pharma PR. I know science. I know how the scientific method works. Psychiatric drugging is at best an empirical approach without a good theoretical basis. As such, the ultimate test of its efficacy should be the subjective experience of the patient. Yet psychiatry routinely ignores the complaints of its often captive clientele. They have abandoned all pretense to do no harm and pursued a socially expedient ideological agenda which has nothing to do with science or medicine. Children are not machines, they're not property (not their parents property and certainly not the psychiatrist's property), they're not experimental animals and they're not vehicles for psychiatrists' reductionist social engineering agendas. Posted by: rich winkel | May 14, 2006 1:56:51 PM I think there isn't enough pychotropics and pharamaeucticals given to children. They are too noisy and have too many mood swings. The younger the better and the drugs make them much more docile. If we get them early enough they are more suggestable later in age and are easier to manipulate. Also I need to make more money in my drug stocks. That is why teenscreen is important to make mandatory. Posted by: Dr. Wundt | May 14, 2006 2:12:14 PM MHRA - In whose Interests? News that GlaxoSmithKline knowingly withheld clinical trial data from the MHRA, the British equivalent of the FDA, regarding the top selling anti-depressant drug Paxil (Seroxat) will add further fuel to the fire and hopefully push for an independent review into how the MHRA could be duped into believing that a drug they have reviewed on numerous occasions was safe. The MHRA are made up of medical experts, some of whom are former employees and shareholders of the pharmaceutical companies they grant licenses to. Surely this is wrong and at the very least there is the suspicion of a conflict of interest? For too long now the MHRA have been hoodwinked by the Pharmaceutical Industry. Lawsuits for damages in respect of harm caused to patients are popping up all over the place, but avoid media and public scrutiny because they are usually settled out of court on the proviso that evidence is not made public. A public enquiry is needed to examine how the MHRA is run and why former Pharmaceutical Industry directors are allowed onto the board. Would a convicted drink driver be allowed to adjudicate on a road safety panel? The MHRA need to pull the plug NOW on their close associations with the Pharmaceutical Industry. The British public expects and naively assumes impartiality and not a regulatory authority whose main interest seems to be one of 'delivering jobs for the boys.' Mr Robert Fiddaman (Group Moderator of the Online Seroxat Support Group) Birmingham, UK http://fiddaman.blogspot.com/ Posted by: ROBERT FIDDAMAN | May 14, 2006 4:40:14 PM Fascinating commentary! I have a particular affinity with the comments by Catherine Creel (5/13 --9:15:16). My belief is that the economic disaster resulting from placing responsibility for increases in autism, cancer and diabetes on the companies which have polluted our air, water and food supply with toxics is so massive that our leaders would never even broach the subject. Far easier to manipulate the population's energy into the latest headline news and into voting for the most monied candidates than bringing up such unpleasant responsibilities of national interest. Besides, big money has brought protection to the guilty. Driven by bottom line/shareholder interests, many American corporations have bought their way into our political system and manipulated legislation to their own protection and best interest. How many toxic waste sites - including the vaunted " superfund sites " - have not been cleaned up as mandated by law due to " the expense " ?? How many people have alzheimer-like symptoms or learning disabilities or autism from the use of aluminum cooking pots, coated baking and cooking utensils, " acceptable " levels of heavy metals in the air and water and mother's milk, pesticide and insecticide residues in food, chemical additives in packaged foods, free-floating chemical particles in everyday household environments, fumes from pesticide treatments in homes and schools? How many times have you heard that a dangerous chemical will be " phased out " over the next ten years because it would pose a hardship on the manufacturer to stop production or sales before current inventory is sold? Your best interests are being traded for someone's profit!!! GET MAD!! Dow Chemical makes BILLIONS of dollars annually all over the world.....their products are in every home.....would they acknowledge any negative effects on humans or animals?? Just look at the warnings on their labels. What about the oil companies and car manufacturers who have allowed (and been allowed) the spewing of toxic emissions into our air for the last 90 years?? They make BILLIONS., too! Do children or joggers or the elderly have " ozone days " as a part of their lives today?? What happened to the clean technologies developed in the 50's and 60's which got bought and buried by companies not wanting to spend money on changing technology because they had a profitable and highly marketable thing going -- and retooling costs too much?? After all, by the time the customers are affected by our products, it will be years down the road and who could ever find out it was us who did it anyway? Meanwhile, bonuses are paid. In the meantime, the drug industry is making BILLIONS treating the sick symptoms generated by human bodies trying desperately to adapt to a chemical-laden environment. And they need bodies as test subjects to see how their new concoctions can be tweeked so that minimum thresholds of acceptability are met - thresholds they have manipulated by their political connections. Have you ever really read the insert in any of your prescriptions?? They tell you quite clearly that this drug is dangerous......but the drug manufacturers' highly paid legal staff has helped them create a legal cover so that YOU become the responsible party for choosing to take their drug . (And if you mention concerns such as this to your doctor you are likely to hear -- " Well, if you read the information on aspirin you probably would never take one of those either. " ) Meanwhile, huge marketing budgets are devoted to ads and infomercials touting new drugs and suggesting you ask your physician for a prescription. Everybody makes out -- except for a few people here or there....but after all, the world population is getting too large anyway........and some companies have actually calculated and determined that legal expenses required to satisfy potential lawsuits for damage are at levels which will not destroy the organization. The operating principle in our country has become rooted in an " I'm gonna get mine " philosophy...and that supposes that " I really don't care if you get yours or what happens to you when I get mine " . Until and unless we all seriously care enough to DO SOMETHING - make time in our busy lives for HARD WORK in areas that do not bring immediate reward- show our children something of ETHICAL BEHAVIOR in the face of frustrating indifference -- AND DEMAND ethical, responsive and responsible governance, then the monied interests will pull us around by their marketing budgets and we will happily imbibe, ingest and tolerate the muck that results from our compliance. And our grandchildren will have a life greatly substandard to the one we inherited from our parents. It was said years ago -- if you are not a part of the solution , you are a part of the problem. In the 60's we had the luxury of time -- in the 2000's we are reaching critical mass in many areas. Cleaning up has become all but impossible due to the cost....why did we get it dirty in the first place?? Regardless of our 'go along' - we have a mess on our hands and we need to fix it. We can choose to be placated and sedated into a 'feel good', tension-less existance -- or realize that LIFE is just that: the opportunity to be fully human for a brief span in the history of the universe. Only you can determine if your time counts for something.....something like protecting the least of us from the clutches of modern-day Mengeles in search of gold. A media and politically-driven campaign may diminish the ugliness ot this drug-testing scenario, but there is truth in there somewhere. And my Grandaddy always said, where there is smoke, something is burning. It would be great if we could start putting out fires wherever we find them. Posted by: Trisa | May 14, 2006 6:23:29 PM OH MY GOD!!!! Children must have rights. How would you like it if someone came along and said we are giving you this drug and you have no choice? Posted by: Norma | May 14, 2006 6:28:19 PM ABC News Home Contact ABC News . Help & Info . Advertising Info . Terms of Use . Privacy Policy/Your California Privacy Rights 2005 ABC News Internet Ventures Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.