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Tots Used as Human Guinea Pigs?
May 17, 2006 9:35 AM
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 17, 2006 | Permalink | User Comments (116)
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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
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?
Toddlers 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:
http://groups.yahoo.com/group/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
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
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