Florida To FDA: No Foster Kids In Psychotropic Trials
40 CommentsBy Ed Silverman // July 19th, 2010 // 8:56 am
Last year, a 7-year-old foster boy named Gabriel Myers committed suicide in Florida and, after reams of publicity and hand-wringing over the use of psychotropic medications in such children, a state task force recommended, among other things, that children never be allowed to participate in a clinical trial designed to evaluate new psychotropic meds or whether such drugs approved for adults should be given to children.
The move was prompted, in part, because a Florida psychiatrist, Sohail Punjwani, who treated the boy before he committed suicide, received an FDA warning letter for failing “to protect the rights, safety and welfare” of children enrolled in clinical trials (back story). Before the suicide, the psychiatrist prescribed to kids several drugs, some of which weren’t approved by the FDA for use on children and had been linked to dangerous side effects, including an increased risk of suicide among children (back story).
As part of the follow-up, George Sheldon, who head’s Florida’s Department of Children and Families, wrote FDA commish Margaret Hamburg for info about any foster children who might have participated in clinical trials for psychotropic meds (read the letter) and asked the FDA to forbid foster kids from participating in these trials. Last month, the agency wrote back to say the agency does not agree with a “blanket prohibition” on enrolling foster children. Why? Such a policy fails to account for the greater risk of off-label prescribing and research involving children can yield benefits that cannot be obtained by tracking usage in adults, Jill Warner, acting associate commissioner for the FDA’s Special Medical Programs, wrote back (see here). Drugmakers, by the way, also have something at stake - they receive an extra six months of marketing exclusivity in return for having conducted the pediatric trials.
We asked Florida officials if they are rethinking their position. The answer? No way. The state is resolute. A department spokeswoman writes us to say this: “There is no impasse. While we appreciate the information provided by the Food and Drug Administration, the Department of Children and Families, not the FDA, is responsible for the protection of children in its care and takes those responsibilities extremely seriously. To that end, we have, by administrative procedures, prohibited the use of children in state care in clinical trials relating to the development of new psychotropic medications.
“Additionally, this Department’s operating procedure on ‘Institutional Oversight of Human Subject Research and Institutional Review Board Designation’ now further specifies: “At no time shall a child in the custody of the Department be allowed to participate in a clinical trial that is designed to develop new psychotropic medications or evaluate the suitability of providing medications previously approved for adults to children” (read more here). She adds that the department expects to send a formal response to the FDA in the “immediate future.” What do you think?
Is Florida Correct To Ban Foster Kids From Such Trials?
- Yes (96%, 638 Votes)
- No (4%, 30 Votes)
Total Voters: 668
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Matthew Holford
Well, there are better alternatives - M&Ms (or any other placebo), for a start. Cheaper, too, in the long term, I imagine.
Matt
Smirnoff
Go Florida!!!!!
Stephany
Foster kids are America’s pharmaceutical industry cash cows, and this is a deplorable representation of the FDA.
Kudos to Florida for taking the job of caring for innocent children seriously.
Eskimo
Does the Florida policy ban only foster children from participation in these clinical trials OR all children in the state, even those living with their biological parents?
The headline and lead paragraph make it seem like the second case, but the lower half of your article has it look more like the first.
keiner
Makes no sense to ban ALL children from such trials, on which clinical data base should paediatric indications be granted?
Frank Blankenship
You’ve got an unwanted kid. How convenient it is to label his or her situation an illness, and put him or her on a drug for it. Given another pair of uncaring parents, you can see how this ‘problem’ gets exasperated.
Children in foster care are being drugged at rate higher than children who are not in foster care. They are, in fact, being over-diagnosed and over-drugged at a rate too high to be explained away by their familial and social situations alone.
The Department of Children and Families is to be commended for the position it has taken on this issue.
Richard
With shrinking state budgets and consequent reduced oversight and increased case loads for foster children monitoring, it makes good sense to make the ban universal and complete. If the state has taken over care of these children, they owe them the highest duty of care. Good for Florida!
Ed Silverman
Dear Eskimo,
Thank you much for your note and your good question. I have amended the headline to more accurately reflect the situation in Florida. My apologies for the confusion. Headline writing is an imperfect art and this one needed to be clarified.
Regards
Ed
Cynical
Better look at Indiana next. After working for Eli Lilly as its VP of Corporate Strategy and Policy, he became governor. During his first year a law was passed MANDATING mental health testing for all children 0-22 (that’s right newborn to 22).
And y’all know where that leads — to drugging of children. And who makes those drugs? Uh, duh, Eli Lilly.
Thing was, when the public found out about the law, it was too late, and school children were being tested and of course found mentally ill and in need of “treatment.” When a lawsuit popped up over this, the state quickly backed off and started concentrating on — guess who — children in the social services, including Medicaid kids, those in the criminal justice system and — ah, yes, FOSTER kids.
Dunno if Indiana’s participating in the drug trials, but by golly they have a foothold on every single child in the state. Just can’t figure how they count 21- and 22-year-olds as “children”. The law is called SEA 529, and the section is called “Social, Emotional and Behavioral Health Plan.” And, yes, it’s still on the books.
Cynical
Forgot to say above that the governor who once worked for Eli Lilly is Mitch Daniels, who is being tossed around as a presidential candidate. Sorry. Fast typing made me slip up.
Heather Staton
Guess which children in Florida are left over to help out with Clinical trials??
This doesn’t stop clinical trials for all children in FL just those particular set of foster xare or state children.
Good starting place for protecting children.
Clinical trials usually need control children that have never been exposed to psych drugs before. Therefore, little or no Foster care children can provide control clinical trial numbers anyway. Clinical trials have to have a control child that has not been exposed to psych drugs- fresh meat.
Foster children and state children do not fit in that category. Their medical profiles are too complicated to generate meaniful results for a clinical trial.
Good starting place for progress.
Smirnoff
Makes perfect sense to ban ALL children from psych drug trials. Not one of these drugs has cured a thing.
keiner
That’s a differnt question.
Walker
Only a covert psychopath like a psychiatrist would support clinical trails on innocent children. Everyone else already knows these drugs only cause harm. The only possible motivation for using psychotropic drugs is finacial gain.
Cynical
The problem is it’s easier to “treat” with straight-jacket drugs than to address the real issues going on in both children’s and adults’ minds.
The evidence is there — they’ve done studies & proven that counseling and couch therapy work better in the long term. But will insurance companies pay what that costs? And even if they do pay, will pyschotherapists be willing to see just 6 or 8 patients max a day, and listen and talk to each one, as opposed to a 15-minute consult and a new prescription?
It’s all about money, no matter which end you’re on.
Jimmy Joe
How anyone can honestly justify taking any chance by administering toxins to an innocent child’s body is beyond me. I question even if parents should have that right. The state definitely has no right or justification to experiment on the growing and developing bodies of children in state care. Abuse within state care has always been fairly rampant around the country anyways so there should be no testing of children in state care.
Cynical
Jimmy Joe do you realize what you’re saying? You’re gonna go straight to Paul Offit’s The Bad List amongst all those raging parents who believe their kids were injured by vaccines.
Then again, Merck itself says no vaccine is 100 percent safe. Found it right here
http://www.merck.com/mmhe/sec23/ch263/ch263l.html
You just have to be able to prove the so-called offending drug actually harmed a child, which can be darned near impossible,even if the child dies in your arms as he gets the injection. In the case of psychotropic drugged Florida children, the whole state was hard to fight, as opposed to a parent who doesn’t know the way around The System.
john rusnak
since they have shown no clinical proof of workability only heresay and “see he’s not running around amok anymore” and ALL their adds preface with “may be caused by this or that” we should subject the psycoanalist to the process of determining workability.I will gladly administer the sometimes seven or eight different drugs in a cocktail that they sometimes give a child.As experts they can relay their findings so we will all know what we are missing..Good work to Florida for standing up for childrens rights!!
John Munn
Absolutly right to ban trials of psychotropic drugs on kids (all kids) as these are dangerous drugs even for adults and should never be used or even tested on kids.
Stephany
Unfortunately, there ARE drug trials in children as young as 7 years old:
http://clinicaltrials.gov/ct2/show/NCT00849693?term=cymbalta+children&rank=2
Eli Lilly
Duloxetine & Prozac
I agree, ALL children should be banned from being entered in a drug trial. The 7 yr olds, whether foster kids or not are at risk.
The FDA is USELESS, the government does not appear to oversee the safety of children when considering psychotropic meds in children.
Leya
It is deplorable what this country is doing. I have read where Nazi Germany did “tests” on the so-called not pure races and handicapped(undesirable and unwanted) and for it to happen in this country is unforgiveable. No child should have to be guinea pigs. That is WRONG!! If the government didn’t get such big profits from the pharmaceutical companies, this kind of thing would not happen. Florida has taken a step toward ending this horror. Now the rest of the states need to step up to the plate. America has a BIG PROBLEM (actually several BIG problems).
Curious
I run into people all the time that make statements about psych drugs. They believe, they themselves, or their children need them. When they get to the topic of testing I ask WHAT TEST. Is there any blood test or brain scan that reasonably identifies a “chemical imbalance” in the brain? These people all say no such testing was done.
I just explained to someone yesterday what “class of drugs” means as it was decided this class of drugs might treat her better than the last one. Based on what? It is not my place to speak of the conditions which some of these people are dealing with, but there are horrors.
In a what came first, the chicken or the egg, scenario. If a drug has the potential to destroy someones thyroid, for instance. If the thyroid is not functioning well in the beginning, could it not be the cause of a bipolar diagnosis? This would mean the thyroid and not the brain is the problem. Or is it that psych drugs destroyed the thyroid?
Where is the science? I’d really like to see it because it is hard to accept that people are being treated with medications that can cause several severe problems without a good scientific basis and only a very long list of behavioral things that could include nearly every person on the planet.
Actually I’d like a clear and science based definition for the term Mental Illness. And even proof of Chemical Imbalances in the Brain (what chemicals, dopamine?, then treat for a dopamine deficiency). I am an open minded person but where is the science in psychiatry?
Majik
That is a start… Now if FL goes after the schools who have GC’s who call in the quack psychiatrist that ask’s a few ?’s which are nothing relative to the child’s mental health, then will write out scripts to dumb down the unruly child. I will then call it a win win for FL. Yes, that is a currant practice in N. FL. where there is only a couple of psych’s for a pop of 70k. There are still areas that are behind the times and undereducated or for lack of a better word do not understand they have rights and can exercise them. I wonder how many other children have died from the hands of greedy pharma & Drs who gained perks or benefits from being over zealous.
Matthew Holford
Well, on the subject of testing psychoactive drugs on the vulnerable, I never miss an opportunity to bring everybody’s attention to MK-ULTRA, wherein the criminal entity (OK, so it’s a minor conviction, but WTF, eh?), Eli supplied the LSD for use on unwitting guinea pigs.
And there are numerous tales of drugs being tested on prison populations. And then there’s Tuskegee, and the New York HIV kids (in the state’s care)… Some vulnerable demographics are easier to predict than others, but the pattern’s the same, throughout: not powerful enough to complain, nor to be valuable enough to be worth protecting.
Me? I like to equalize the imbalance.
Matt
Dr. Craig
Anyone who has been watching the decline of our society, which has been directly related to illegal and now legal mind altering drugs, as I have been for the past forty years knows no adult should be on psychotropic drugs let alone defenseless children. Is there some point I’m missing that makes it okay to destroy our children.
Oliver Asato
I would really like to know how much Dr. Sohail Punjwani receives for drugging children. What is the money trail here?
It is beyond me how anyone cannot see the importance of love and affection in a child’s life. Drugs are no substitute. And yet, psychiatry cannot, actually refuses to acknowledge this. I guess you can’t put a price tag on love for a child and therefore you can’t make a profit.
Has psychiatry lost all sense of moral responsibility?
Oliver Asato
Ken Huber
This is such a small planet.
Let’s come to present time and help these kids.
Be brave, you can do it.
The world bankers and drug companies really are out numbered.
elmore
Charles Dickens changed Victorian England–and laws regarding child labor and poor houses, among other things–with his books. I wish there were someone as popular and talented as he, who decided to write about the deplorable way in which foster kids–among the most innocent and least powerful members of our society–are drugged up.
Matthew Holford
Oliver Asato wrote:
“…It is beyond me how anyone cannot see the importance of love and affection in a child’s life. Drugs are no substitute…”
Right on the money. But you know what really kills them? It’s because they are more than capable of comparing how they’re being treated with how others are being treated. Then, when it is beyond question in their own minds that they are being treated differently (and worse), with fewer advantages and opportunities offered to them, they start to investigate why.
And do you know what they decide? There is no reason that they should be treated as less, other than that is what others believe is normal, not to say acceptable. Except that, even if they were able to verbalize it in that way, they’d struggle to find anybody to agree that it was true. And yet it is.
Matt
Lucille Femine
Why just kids?? EVERYONE shuld be banned from psych drug testing. There’s hardly anything more dangerous in the world than psychiatry and their killer drugs.
SteveM
Re: Stephany above and the Cymbalta pediatric clinical trial.
I contacted CDER and asked them why Duloxetine discontinuation side effect tracking is not listed as a Secondary measure in the trial. I also included this illustrative web self-report:
“I have watched this drug completely destroy my husband. He was initially put on it for depression, anxiety and chronic back pain. It made him lathargic, and the pain increased and spread toother parts of his body. Now that we are trying to wan him off, the withdrawals are horrible! The suffering this man has had to endure is inhumane at the least. I don’t believe the doctors were properly educated on this terrible drug so in turn patients aren’t able to make a clear educated decision as to take this medication to begin with. I have placed a complaint with th FDA as well as with Eli Lilly. I have also placed a complaint with his doctor. I am so angry and to know that the weaning process will takes months is just unacceptable to me. Get online and type in Cymbalta withdrawal and Cymbalta side efffects and see the other hundreds of people who are suffering with little to no help from the medical field. Also, you will see the desperate attempts of some who are trying to get off this drug. There WILL be a death as a result of some of these tactics and I forsee a class action law suit in he future for Eli Lilly and any of the medical professionals who refuse to hear the cries of so many desperate people.”
I to mentioned to CDER that are thousands of similar self-reports on the web. And that Eli-Lilly has not developed a clinically proven discontinuation protocol. More Cymbalta car wrecks pile up day after day.
I asked CDER to consider a 9 year old experiencing the above discontinuation profile. I also inquired about how fully informed the parents are who enroll their children in the study. I.e., what parent in their right mind would enroll their kid after becoming aware of the discontinuation horror stories?
I received a form letter back from CDER essentially telling me to pound sand. No modifications have been made to the study design related to discontinuation.
FDA, your tax dollars at work…
JamesC
Ban psych drug testing on everyone. They are dangerous and destructive.
David C
The only thing “proven” about the administration of psych drugs to anyone is that they are dangerous and don’t cure anything. The only thing “proven” about testing is that it makes drug companies richer. The FDA has failed in it’s mandate to protect the American public from unscrupulous frauds and quacks. Drug companies have become the “snake oil” salesman of the past.
zenon duda
Way WAY WAY too much of this stuff. I have even personally heard of school board members insisting children be drugged. Kids need advocates!!!!
susan W.
No child should be drugged in the first place let alone be experimented on. Their young growing minds are no place for dangerous mind altering drugs that kill and maime.
Thousands have died on these things and have killed and harmed others while on them.
As a teacher I
Cara LR
This is a step in the right direction. Now I want to see this ENFORCED. Public statements such as these are too often made just to look good. In this case, childrens’ lives are at stake. The real solution for these kids is the loving care by parents and proper instruction in schools that they deserve.
Stephany
SteveM–Great to read you contacted CDER, thanks for doing that. I contacted a drug trial principle investigator once regarding trialing Zoloft in kids and had a lengthy phone conversation where he promised no harm would be done to the children. I had a hard time listening to that, considering my daughter was given Zoloft at age 11 and had horrendous withdrawals from it.
Keep pounding the sand, it’s all we can do for the children, it’s the least we can do as adults watching over them.
Betty
This is also going on In Toronto Canada where a drugging factory is flourishing on the backs of children offering them a 15 minute convenient diagnosis entitling them to prey on children with a potent cocktail of drugs children and teens are being used in a clinic in Toronto as test rats for these same drugs even Juvenile diabetics insulin dependent Wellbutrin as one of the drugs of choice to a ten year old who is also insulin dependent , removed from the market place in 1986 because it was killing too many patients according to the FDA he was also administered a cocktail of other psychotic drugs it has been found out that this boy is allergic (mold,foods and the preservative in his insulin )and to many things which were causing his behavior problems and for this his brain has been ruined being put on these mind altering drugs , and yes he was taken away from his mother and used as one of these rats
He is very angry as to what the Psychiatrists did to him he is also very angry towards his granpa for trying to help him by suggesting help for a loved one especially a psychiatrist who just may need help himself ? would he the psychiatrist take these potent drugs home and administer to his children ? I do not think so,,, surely the psychiatric team is not hopefully that sick
It is very dangerous especially when it comes suggesting help from a psychiatrists not all some use Talk therapy nutrition exercise etc not potent drugs which according to psychiatrist in Chicago those drugs do more harm than good
Trudy Hensley
Foster children are human beings and therefore have human rights.(see youthforhumanrights) Unfortunately no one in foster homes is protecting their human rights, so they are a cash cow for Big Pharma. Evil.
A psychiatrist needs no medical test in order to diagnose disease.(see CCHR, Citizen’s Commission on Human Rights)
Psychiatry makes up diseases and votes on them, and then puts their made-up diseases in their pseudo-bible called the Diagnostical Statistical Manual. Why? Because it “sounds”
scientific. See the history of psychiatry (Psychiatry, An Industry of Death)
Think for yourself after this assignment. It will be a matter of “life and death” for your child or another child. Is this too much research when your child’s life is at stake?
Psychiatry is getting away with real murder simply because parents are not aware that it is complete fraud because they are accepting everything that this “so-called professional” is saying, “hook, line and sinker”.
Wake up people, as your family is next! Psychiatrists believe that all are insane, and are systematically drugging the whole world.
Dead serious,
Trudy
Educated parent, who saved my children from being drugged by these “legalized drug pushers”
Wendy Keenan
Psychiatry should be abollished. They are the ones with the disorders. To give dangerous drugs to innocent kids is child abuse and we all need to keep putting pressure on the government to stop this insanity. These kids are our future generation and they deserve a good start in life,not a diet of addictive poison!