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??

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.

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.

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.

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?

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.

I think part of the question is:

How did this proposal pass for NIH approval?

Since when are children of these ages diagnosed with Bipolar disorder? The administration of this drug to children of these ages is totally inappropriate.

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.

"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.

Would these soulless psycho's test the drug on themselves or their family???

Parents who subject their children to this testing should be turned into child protective services!

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.

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?

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.

you didn't say that testing was actually being done.

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.

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..

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.

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.