Punish Mom Who Sent Adopted Boy Back?
April 09, 2010 11:51 PM
Note from unhappygrammy-What about all the children stolen from their families in the U.S. and placed in foster care, who are thrown out of these homes at eighteen years of age, when our government stops paying the foster strangers for their care? How can this be in the childs best interest? This woman paid to adopt this child. The government wasn't paying her.
We began tonight's broadcast with a report from Juju Chang about Tennessee mother Torry Hansen, who sent her 7-year-old adopted son Artyem Saviliev back to Russia by himself after just six months.
In a note she packed with the boy, she claimed the orphanage had misled her and failed to let her know the child was, according to her, "mentally unstable."
Hansen is under criminal investigation and so far, has declined to speak to authorities.
Meanwhile, outraged Russian officials have threatened to freeze adoptions to the United States.
So tonight, we ask: What -- if anything -- should happen to her?
Is she a criminal? Should she be punished? And if so, how?
Click HERE to read the full ABCNews.com report.
--------------------
UPDATE: Here is the segment from last night, "Send Him Back Alone?"
http://blogs.abcnews.com/nightlinedailyline/2010/04/punish-mom-who-sent-adopted-boy-back.html
Exposing Child UN-Protective Services and the Deceitful Practices They Use to Rip Families Apart/Where Relative Placement is NOT an Option, as Stated by a DCYF Supervisor
Unbiased Reporting
What I post on this Blog does not mean I agree with the articles or disagree. I call it Unbiased Reporting!
Isabella Brooke Knightly and Austin Gamez-Knightly
In Memory of my Loving Husband, William F. Knightly Jr. Murdered by ILLEGAL Palliative Care at a Nashua, NH Hospital
Sunday, April 11, 2010
Saturday, April 10, 2010
Cops taser harmless legless dad in wheelchair so Child Protective Services can take his child
Cops taser harmless legless dad in wheelchair so Child Protective Services can take his child
September 22, 6:24 AMAlbany CPS and Family Court ExaminerDaniel Weaver
The Associated Press is reporting that the police tasered a wheel chair bound, double amputee twice because they claimed he was uncooperative in turning his two-year-old over to Child Protective Services. So far no one has said why Child Protective Services was taking his child.
This story will most likely end up on my list of the top ten Child Protective Services horror stories of the year.
In the video below, the father says that his daughter was sitting in his lap the whole time this was going on. For the police to use a taser on this man in the presence of his daughter, when it was not necessary, is a form of child abuse as far as I am concerned. But then the police and child protective services often abuse children in the very act of taking them from their parents.
http://www.examiner.com/x-14537-Albany-CPS-and-Family-Court-Examiner~y2009m9d22-Cops-taser-harmless-legless-man-in-wheelchair-so-Child-Protective-Services-can-take-his-child
September 22, 6:24 AMAlbany CPS and Family Court ExaminerDaniel Weaver
The Associated Press is reporting that the police tasered a wheel chair bound, double amputee twice because they claimed he was uncooperative in turning his two-year-old over to Child Protective Services. So far no one has said why Child Protective Services was taking his child.
This story will most likely end up on my list of the top ten Child Protective Services horror stories of the year.
In the video below, the father says that his daughter was sitting in his lap the whole time this was going on. For the police to use a taser on this man in the presence of his daughter, when it was not necessary, is a form of child abuse as far as I am concerned. But then the police and child protective services often abuse children in the very act of taking them from their parents.
http://www.examiner.com/x-14537-Albany-CPS-and-Family-Court-Examiner~y2009m9d22-Cops-taser-harmless-legless-man-in-wheelchair-so-Child-Protective-Services-can-take-his-child
Foster Parents Do Not Claim their Monthly Stipend from CPS as Income They Pay No Taxes on This Money
Foster Parents Do Not Claim their Monthly Stipend from CPS as Income They Pay No Taxes on This Money
April 7, 2010yvonnemason
Autumn Destiny DeShawna Thomason, Carly and Sara Louvelle Texanna Wilfawn these are the children Donna the Foster Care Provider is Making a killing off of.
Child Protective Services are not the only ones making a killing off the backs of our children in violaton of the 13th Amendment that “No Man shall be enslaved”- but so are the Foster Care Providers. The information I pulled is directly from the IRS Site. The Monthly income that the Foster Care Provider collects each month off the backs of my three grandchildren Autumn Destiny DeShawana Thomason, Carly and Sara Wilfawn which comes to at least $1000.00 per month for the three of them is not and I repeat NOT included as income for that Provider. Donna the Foster Care Provider does not have to claim it either on the state level or the Federal level. So just for the sake of this discussion let’s say she gets 416.00 for the baby per month ,and 471. 00 for the two older girls. This is the going rate in Georgia for foster kids. This does not include the stimed she gets because she has put the oldest girl on drugs or the stimed she gets because they are siblings. Nor the stimed she gets twice a year for a clothing allowance, or their medicad- reduced lunches, eye care and dental care. Her income for the month is 1,358.00 for the year it is 16,296. and let’s just say she has three other children who are in foster care. That is another $12,000.00 so a total of $28,296.00 has been given to that Foster Care Provider and it is free money. She doesn’t have to claim it as income. Plus and here is the best part. The foster children are allowed to be claimed as dependants and they may also qualify for the Child Tax Credit and maybe even the earned income credit.
My grandchildren are the cash cow for this foster care provider. My grandchildren could be with their mother – if $13,296 had been re-routed to her instead of the Foster Care Provider. What if DFCS had helped provide her housing under the Section 8 funding and if she had help with child care- this would solve the problem they say they have – Why pay strangers when that money could go to Samantha? The reason no bonuses for DFCS when they terminate the rights of the parent and adopt out the girls. This is a clear violation of the 13th Amendment. It is so balant it is almost funny! No wonder the Foster Care Provider can afford to take the family to Myrtle Beach all the time and forces Sam not to be able to see her girls. They are footing the bill for the trip.
I included below the direct quote from the IRS as well as their website.
Foster care providers. Payments you receive from a state, political subdivision, or a qualified foster care placement agency for providing care to qualified foster individuals in your home generally are not included in your income. However, you must include in your income payments received for the care of more than 5 individuals age 19 or older and certain difficulty-of-care payments.
A qualified foster individual is a person who:
Is living in a foster family home, and
Was placed there by:
An agency of a state or one of its political subdivisions, or
A qualified foster care placement agency.
A “Qualifying Child”
FS-2005-7, January 2005
Uniform Definition
A “qualifying child” may enable a taxpayer to claim several tax benefits, such as head of household filing status, the exemption for a dependent, the child tax credit, the child and dependent care credit and the earned income tax credit. Prior to 2005, each of these items defined a qualifying child differently, leaving many taxpayers confused.
The Working Families Tax Relief Act of 2004 set a uniform definition of a qualifying child, beginning for Tax Year 2005. This standard definition applies to all five of the tax benefits noted above, with each benefit having some additional rules.
In general, to be a taxpayer’s qualifying child, a person must satisfy four tests:
Relationship — the taxpayer’s child or stepchild (whether by blood or adoption), foster child, sibling or stepsibling, or a descendant of one of these.
Residence — has the same principal residence as the taxpayer for more than half the tax year. Exceptions apply, in certain cases, for children of divorced or separated parents, kidnapped children, temporary absences, and for children who were born or died during the year.
Age — must be under the age of 19 at the end of the tax year, or under the age of 24 if a full-time student for at least five months of the year, or be permanently and totally disabled at any time during the year.
Support — did not provide more than one-half of his/her own support for the year.
If a child is claimed as a qualifying child by two or more taxpayers in a given year, the child will be the qualifying child of:
the parent;
if more than one taxpayer is the child’s parent, the one with whom the child lived for the longest time during the year, or, if the time was equal, the parent with the highest AGI;
if no taxpayer is the child’s parent, the taxpayer with the highest adjusted gross income (AGI).
Additional Rules
While the four qualifying child tests generally apply for the five tax benefits noted above, there are some additions or variations for particular provisions:
Dependent — a qualifying child must also meet these tests:
Nationality — be a U.S. citizen or national, or a resident of the U.S., Canada or Mexico. There is an exception for certain adopted children.
Marital status — if married, did not file a joint return for that year, unless the return is filed only as a claim for refund and no tax liability would exist for either spouse if they had filed separate returns.
Head of Household Filing Status — a qualifying child is determined without regard to the exception for children of divorced or separated parents. Also, a qualifying child who is married at the end of the year must meet the marital status and nationality tests for a dependent (above).
Credit for Child and Dependent Care Expenses — a qualifying child must be under the age of 13 or permanently and totally disabled. A qualifying child is determined without regard to the exception for children of divorced or separated parents and the exception for kidnapped children.
Child Tax Credit — a qualifying child must be under age 17 and a U.S. citizen or national or a U.S. resident.
Earned Income Tax Credit — a qualifying child does not have to meet the support test. Also, a qualifying child must have lived with the taxpayer in the United States for more than half the year and have a social security number that is valid for employment in the United States. A qualifying child is determined without regard to the exception for children of divorced or separated parents. If a qualifying child is married, he or she must also meet the marital status and nationality tests for a dependent (above).
Changes to Certain Benefits
The new law does not change the operation of the Child Tax Credit, but it does affect these benefits:
Dependent — There are two types of dependents, a qualifying child and a qualifying relative. The five dependency tests — relationship, gross income, support, joint return and citizenship/residency — continue to apply to a qualifying relative. A child who is not a qualifying child might still be a dependent as a qualifying relative. If you are a dependent of another person, you cannot claim any dependents on your own return. .
Head of Household Filing Status — A taxpayer is eligible for head of household filing status only with respect to a qualifying child or the taxpayer’s dependent. But the taxpayer cannot file as head of household for a person who is a dependent only because he or she lived with the taxpayer for the whole year or because the taxpayer may claim him or her as a dependent under a multiple support agreement.
Child Tax Credit — The taxpayer is no longer required to care for a foster child, sibling, or sibling’s descendant as one’s own child.
Credit for Child and Dependent Care Expenses — The taxpayer is no longer required to pay over half the costs of maintaining a household for the qualifying individual. But, an individual who is not a qualifying child must have the same principal residence as the taxpayer for more than half the year.
Earned Income Tax Credit — The taxpayer is no longer required to care for a foster child, sibling, or sibling’s descendant as one’s own child.
http://www.irs.gov/publications/p17/ch12.html#en_US_publink1000172048
http://protectingourchildrenfrombeingsold.wordpress.com/2010/04/07/foster-parents-do-not-claim-their-monthly-stimed-from-cps-as-income-they-pay-no-taxes-on-this-money/
April 7, 2010yvonnemason
Autumn Destiny DeShawna Thomason, Carly and Sara Louvelle Texanna Wilfawn these are the children Donna the Foster Care Provider is Making a killing off of.
Child Protective Services are not the only ones making a killing off the backs of our children in violaton of the 13th Amendment that “No Man shall be enslaved”- but so are the Foster Care Providers. The information I pulled is directly from the IRS Site. The Monthly income that the Foster Care Provider collects each month off the backs of my three grandchildren Autumn Destiny DeShawana Thomason, Carly and Sara Wilfawn which comes to at least $1000.00 per month for the three of them is not and I repeat NOT included as income for that Provider. Donna the Foster Care Provider does not have to claim it either on the state level or the Federal level. So just for the sake of this discussion let’s say she gets 416.00 for the baby per month ,and 471. 00 for the two older girls. This is the going rate in Georgia for foster kids. This does not include the stimed she gets because she has put the oldest girl on drugs or the stimed she gets because they are siblings. Nor the stimed she gets twice a year for a clothing allowance, or their medicad- reduced lunches, eye care and dental care. Her income for the month is 1,358.00 for the year it is 16,296. and let’s just say she has three other children who are in foster care. That is another $12,000.00 so a total of $28,296.00 has been given to that Foster Care Provider and it is free money. She doesn’t have to claim it as income. Plus and here is the best part. The foster children are allowed to be claimed as dependants and they may also qualify for the Child Tax Credit and maybe even the earned income credit.
My grandchildren are the cash cow for this foster care provider. My grandchildren could be with their mother – if $13,296 had been re-routed to her instead of the Foster Care Provider. What if DFCS had helped provide her housing under the Section 8 funding and if she had help with child care- this would solve the problem they say they have – Why pay strangers when that money could go to Samantha? The reason no bonuses for DFCS when they terminate the rights of the parent and adopt out the girls. This is a clear violation of the 13th Amendment. It is so balant it is almost funny! No wonder the Foster Care Provider can afford to take the family to Myrtle Beach all the time and forces Sam not to be able to see her girls. They are footing the bill for the trip.
I included below the direct quote from the IRS as well as their website.
Foster care providers. Payments you receive from a state, political subdivision, or a qualified foster care placement agency for providing care to qualified foster individuals in your home generally are not included in your income. However, you must include in your income payments received for the care of more than 5 individuals age 19 or older and certain difficulty-of-care payments.
A qualified foster individual is a person who:
Is living in a foster family home, and
Was placed there by:
An agency of a state or one of its political subdivisions, or
A qualified foster care placement agency.
A “Qualifying Child”
FS-2005-7, January 2005
Uniform Definition
A “qualifying child” may enable a taxpayer to claim several tax benefits, such as head of household filing status, the exemption for a dependent, the child tax credit, the child and dependent care credit and the earned income tax credit. Prior to 2005, each of these items defined a qualifying child differently, leaving many taxpayers confused.
The Working Families Tax Relief Act of 2004 set a uniform definition of a qualifying child, beginning for Tax Year 2005. This standard definition applies to all five of the tax benefits noted above, with each benefit having some additional rules.
In general, to be a taxpayer’s qualifying child, a person must satisfy four tests:
Relationship — the taxpayer’s child or stepchild (whether by blood or adoption), foster child, sibling or stepsibling, or a descendant of one of these.
Residence — has the same principal residence as the taxpayer for more than half the tax year. Exceptions apply, in certain cases, for children of divorced or separated parents, kidnapped children, temporary absences, and for children who were born or died during the year.
Age — must be under the age of 19 at the end of the tax year, or under the age of 24 if a full-time student for at least five months of the year, or be permanently and totally disabled at any time during the year.
Support — did not provide more than one-half of his/her own support for the year.
If a child is claimed as a qualifying child by two or more taxpayers in a given year, the child will be the qualifying child of:
the parent;
if more than one taxpayer is the child’s parent, the one with whom the child lived for the longest time during the year, or, if the time was equal, the parent with the highest AGI;
if no taxpayer is the child’s parent, the taxpayer with the highest adjusted gross income (AGI).
Additional Rules
While the four qualifying child tests generally apply for the five tax benefits noted above, there are some additions or variations for particular provisions:
Dependent — a qualifying child must also meet these tests:
Nationality — be a U.S. citizen or national, or a resident of the U.S., Canada or Mexico. There is an exception for certain adopted children.
Marital status — if married, did not file a joint return for that year, unless the return is filed only as a claim for refund and no tax liability would exist for either spouse if they had filed separate returns.
Head of Household Filing Status — a qualifying child is determined without regard to the exception for children of divorced or separated parents. Also, a qualifying child who is married at the end of the year must meet the marital status and nationality tests for a dependent (above).
Credit for Child and Dependent Care Expenses — a qualifying child must be under the age of 13 or permanently and totally disabled. A qualifying child is determined without regard to the exception for children of divorced or separated parents and the exception for kidnapped children.
Child Tax Credit — a qualifying child must be under age 17 and a U.S. citizen or national or a U.S. resident.
Earned Income Tax Credit — a qualifying child does not have to meet the support test. Also, a qualifying child must have lived with the taxpayer in the United States for more than half the year and have a social security number that is valid for employment in the United States. A qualifying child is determined without regard to the exception for children of divorced or separated parents. If a qualifying child is married, he or she must also meet the marital status and nationality tests for a dependent (above).
Changes to Certain Benefits
The new law does not change the operation of the Child Tax Credit, but it does affect these benefits:
Dependent — There are two types of dependents, a qualifying child and a qualifying relative. The five dependency tests — relationship, gross income, support, joint return and citizenship/residency — continue to apply to a qualifying relative. A child who is not a qualifying child might still be a dependent as a qualifying relative. If you are a dependent of another person, you cannot claim any dependents on your own return. .
Head of Household Filing Status — A taxpayer is eligible for head of household filing status only with respect to a qualifying child or the taxpayer’s dependent. But the taxpayer cannot file as head of household for a person who is a dependent only because he or she lived with the taxpayer for the whole year or because the taxpayer may claim him or her as a dependent under a multiple support agreement.
Child Tax Credit — The taxpayer is no longer required to care for a foster child, sibling, or sibling’s descendant as one’s own child.
Credit for Child and Dependent Care Expenses — The taxpayer is no longer required to pay over half the costs of maintaining a household for the qualifying individual. But, an individual who is not a qualifying child must have the same principal residence as the taxpayer for more than half the year.
Earned Income Tax Credit — The taxpayer is no longer required to care for a foster child, sibling, or sibling’s descendant as one’s own child.
http://www.irs.gov/publications/p17/ch12.html#en_US_publink1000172048
http://protectingourchildrenfrombeingsold.wordpress.com/2010/04/07/foster-parents-do-not-claim-their-monthly-stimed-from-cps-as-income-they-pay-no-taxes-on-this-money/
Who Really Killed These Children In Foster Care- The Foster Care Provider Or CPS- The Vote is both Equally Responsible
Who Really Killed These Children In Foster Care- The Foster Care Provider Or CPS- The Vote is both Equally Responsible
April 10, 2010yvonnemason
The Question is this will these girls be next? The older one Shawna has been placed on psychrotic drugs
Autumn Destiny DeShawna Thomason, Carly and Sara Louvelle Texanna Wilfawn Snatched by Jackson County Ga DFCD
[caption id="attachment_952" align="alignleft" width="289" caption="Gabriel Myers seven years old Murdered at the hands of CPS"][/caption]
FDA warns psychiatrist who treated dead foster child
The psychiatrist who treated the Broward foster child who killed himself last year is now in hot water with the FDA.
Seven-year-old Gabriel Myers hanged himself with a shower cord in a Margate foster home.
Photo
BY CAROL MARBIN MILLER
cmarbin@miamiherald.com
A South Florida psychiatrist who was treating a 7-year-old foster child before the boy committed suicide last year has received a warning from federal drug regulators who say he failed “to protect the rights, safety and welfare” of children enrolled in clinical drug trials.
In a strongly worded letter dated Feb. 4, regulators at the U.S. Food and Drug Administration said Dr. Sohail Punjwani over-medicated children who were enrolled in clinical trials for undisclosed drugs. One girl, the letter said, slashed her wrists while hallucinating.
Another, a 13-year-old, “experienced sedation and dizziness during the study,” the letter said.
The warning letter, a harsh and rare form of discipline by the agency, says Punjwani failed to “adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations.”
“Your failure to conduct the requisite safety measures contributed to the unnecessary exposure of pediatric subjects to significant overdoses, which jeopardized the subjects’ rights, safety and welfare,” the letter says.
Punjwani did not return calls from The Miami Herald seeking comment.
Punjwani, who practices in Tamarac and has offices elsewhere in South Florida, was treating 7-year-old Gabriel Myers when the boy hanged himself with a shower cord in a Margate foster home. The boy’s death prompted a yearlong probe by a Department of Children & Families task force, as well as proposed legislation before the Florida Senate.
Before Gabriel’s death, Punjwani had prescribed several powerful mental health drugs — some of which had not been approved by the FDA for use on children and had been linked to dangerous side effects, including an increased risk of suicide among children.
Punjwani also was sued last summer by a Tamarac mother who claims her son, 16-year-old Emilio Villamar, died after being over-medicated with a group of mental health drugs at a Fort Lauderdale psychiatric hospital.
The letter mailed to Punjwani does not specify the names or types of drugs the doctor was testing, and a spokeswoman for the FDA, Sandy Walsh, said such details are kept confidential to protect drug companies.
Walsh said the FDA does not send out such warning letters often, and the agency considers breaches of its regulations to be “very serious.” The letter was signed by Leslie K. Ball, a doctor who heads the compliance office of the Division of Scientific Investigations, and Constance Cullity, a doctor who is also a compliance officer.
For years, drug makers did not study most medications on children, largely due to ethical concerns over using kids as test subjects. More recently, however, Congress passed laws to encourage pharmaceutical companies to test their drugs for safety and efficacy with children by extending patents on drugs approved for adults.
In a trial for one drug that was not identified, Punjwani gave one child dosages “in excess of… specified limits,” the letter says.
The child was discontinued from the trial before it was completed, the letter says, “due to worsening auditory hallucinations that apparently caused the subject to lacerate her wrists.” The girl was “overdosed” on the drug for more than two weeks.
The letter says Punjwani submitted a corrective action plan to the FDA and revised his procedures to better protect his research subjects from dosing missteps. “However,” the letter says, “we are concerned that the response is not adequate to prevent future recurrence of the violation.”
The clinical trials for a different drug were to adhere to a series of protocols that specified what dosage of the drug was to be used, depending on the child’s weight, the letter states. But for six of seven children — chosen at random — who received one of the tested drugs in Punjwani’s study, the dosage exceeded what was spelled out in the protocol.
One child who weighed 103 pounds, for example, “was overdosed on study medication for 20 consecutive days while participating in the study,” the letter states. The child is identified only as “Subject 1001.”
A child identified as “Subject 1003,” who was 15 at the time of the trials, “was overdosed on study medication for 21 consecutive days while participating in the study,” the letter says. “Subject 1004,” a 16-year-old, “received doses in excess of the maximum target dose for 3 consecutive days while participating,” the letter says.
A 10-year-old, identified as “Subject 1007,” was “overdosed” for nearly two weeks while on the study, the letter states.
Department of Children & Families Secretary George Sheldon, who appointed a task force last year to study Gabriel’s death, said Monday he is asking the FDA to compare a list of Florida foster children with lists ofchildren enrolled in Punjwani’s clinical trials. Sheldon said he was acting on concerns that children in state care may have been involved in clinical trials, which is against state law.
The FDA letter, Sheldon said, “raises clear ethical issues and judgment issues that we need to clearly understand.” If foster kids were enrolled in clinical trials, he said, “we will need to take it to another level.”
Read more: http://www.miamiherald.com/2010/03/16/1531156/psychiatrist-gets-warning-from.html#ixzz0jwYp5YQx
http://protectingourchildrenfrombeingsold.wordpress.com/2010/04/10/who-really-killed-these-children-in-foster-care-the-foster-care-provider-or-cps-the-vote-is-both-equally-responsible/
April 10, 2010yvonnemason
The Question is this will these girls be next? The older one Shawna has been placed on psychrotic drugs
Autumn Destiny DeShawna Thomason, Carly and Sara Louvelle Texanna Wilfawn Snatched by Jackson County Ga DFCD
[caption id="attachment_952" align="alignleft" width="289" caption="Gabriel Myers seven years old Murdered at the hands of CPS"][/caption]
FDA warns psychiatrist who treated dead foster child
The psychiatrist who treated the Broward foster child who killed himself last year is now in hot water with the FDA.
Seven-year-old Gabriel Myers hanged himself with a shower cord in a Margate foster home.
Photo
BY CAROL MARBIN MILLER
cmarbin@miamiherald.com
A South Florida psychiatrist who was treating a 7-year-old foster child before the boy committed suicide last year has received a warning from federal drug regulators who say he failed “to protect the rights, safety and welfare” of children enrolled in clinical drug trials.
In a strongly worded letter dated Feb. 4, regulators at the U.S. Food and Drug Administration said Dr. Sohail Punjwani over-medicated children who were enrolled in clinical trials for undisclosed drugs. One girl, the letter said, slashed her wrists while hallucinating.
Another, a 13-year-old, “experienced sedation and dizziness during the study,” the letter said.
The warning letter, a harsh and rare form of discipline by the agency, says Punjwani failed to “adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations.”
“Your failure to conduct the requisite safety measures contributed to the unnecessary exposure of pediatric subjects to significant overdoses, which jeopardized the subjects’ rights, safety and welfare,” the letter says.
Punjwani did not return calls from The Miami Herald seeking comment.
Punjwani, who practices in Tamarac and has offices elsewhere in South Florida, was treating 7-year-old Gabriel Myers when the boy hanged himself with a shower cord in a Margate foster home. The boy’s death prompted a yearlong probe by a Department of Children & Families task force, as well as proposed legislation before the Florida Senate.
Before Gabriel’s death, Punjwani had prescribed several powerful mental health drugs — some of which had not been approved by the FDA for use on children and had been linked to dangerous side effects, including an increased risk of suicide among children.
Punjwani also was sued last summer by a Tamarac mother who claims her son, 16-year-old Emilio Villamar, died after being over-medicated with a group of mental health drugs at a Fort Lauderdale psychiatric hospital.
The letter mailed to Punjwani does not specify the names or types of drugs the doctor was testing, and a spokeswoman for the FDA, Sandy Walsh, said such details are kept confidential to protect drug companies.
Walsh said the FDA does not send out such warning letters often, and the agency considers breaches of its regulations to be “very serious.” The letter was signed by Leslie K. Ball, a doctor who heads the compliance office of the Division of Scientific Investigations, and Constance Cullity, a doctor who is also a compliance officer.
For years, drug makers did not study most medications on children, largely due to ethical concerns over using kids as test subjects. More recently, however, Congress passed laws to encourage pharmaceutical companies to test their drugs for safety and efficacy with children by extending patents on drugs approved for adults.
In a trial for one drug that was not identified, Punjwani gave one child dosages “in excess of… specified limits,” the letter says.
The child was discontinued from the trial before it was completed, the letter says, “due to worsening auditory hallucinations that apparently caused the subject to lacerate her wrists.” The girl was “overdosed” on the drug for more than two weeks.
The letter says Punjwani submitted a corrective action plan to the FDA and revised his procedures to better protect his research subjects from dosing missteps. “However,” the letter says, “we are concerned that the response is not adequate to prevent future recurrence of the violation.”
The clinical trials for a different drug were to adhere to a series of protocols that specified what dosage of the drug was to be used, depending on the child’s weight, the letter states. But for six of seven children — chosen at random — who received one of the tested drugs in Punjwani’s study, the dosage exceeded what was spelled out in the protocol.
One child who weighed 103 pounds, for example, “was overdosed on study medication for 20 consecutive days while participating in the study,” the letter states. The child is identified only as “Subject 1001.”
A child identified as “Subject 1003,” who was 15 at the time of the trials, “was overdosed on study medication for 21 consecutive days while participating in the study,” the letter says. “Subject 1004,” a 16-year-old, “received doses in excess of the maximum target dose for 3 consecutive days while participating,” the letter says.
A 10-year-old, identified as “Subject 1007,” was “overdosed” for nearly two weeks while on the study, the letter states.
Department of Children & Families Secretary George Sheldon, who appointed a task force last year to study Gabriel’s death, said Monday he is asking the FDA to compare a list of Florida foster children with lists ofchildren enrolled in Punjwani’s clinical trials. Sheldon said he was acting on concerns that children in state care may have been involved in clinical trials, which is against state law.
The FDA letter, Sheldon said, “raises clear ethical issues and judgment issues that we need to clearly understand.” If foster kids were enrolled in clinical trials, he said, “we will need to take it to another level.”
Read more: http://www.miamiherald.com/2010/03/16/1531156/psychiatrist-gets-warning-from.html#ixzz0jwYp5YQx
http://protectingourchildrenfrombeingsold.wordpress.com/2010/04/10/who-really-killed-these-children-in-foster-care-the-foster-care-provider-or-cps-the-vote-is-both-equally-responsible/
Friday, April 9, 2010
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