Who Really Killed These Children In Foster Care- The Foster Care Provider Or CPS- The Vote is both Equally Responsible


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

Gabriel Myers seven years old Murdered at the hands of CPS

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

About yvonnemason

Background:  The eldest of five children, Yvonne was born May 17, 1951 in Atlanta, Georgia. Raised in East Point, Georgia, she moved to Jackson County, Ga. until 2006 then moved to Port St. Lucie, Florida where she currently makes her home.  Licensed bounty hunter for the state of Georgia. Education:  After a 34 year absence, returned to college in 2004. Graduated with honors in Criminal Justice with an Associate’s degree from Lanier Technical College in 2006. Awards:  Nominated for the prestigious GOAL award in 2005 which encompasses all of the technical colleges. This award is based not only on excellence in academics but also leadership, positive attitude and the willingness to excel in one’s major. Affiliations:  Beta Sigma Phi Sorority  Member of The Florida Writer’s Association – Group Leader for St Lucie County The Dream:  Since learning to write at the age of five, Yvonne has wanted to be an author. She wrote her first novel Stan’s Story beginning in 1974 and completed it in 2006. Publication seemed impossible as rejections grew to 10 years. Determined, she continued adding to the story until her dream came true in 2006. The Inspiration:  Yvonne’s brother Stan has been her inspiration and hero in every facet of her life. He was stricken with Encephalitis at the tender age of nine months. He has defied every roadblock placed in his way and has been the driving force in every one of her accomplishments. He is the one who taught her never to give up The Author: Yvonne is currently the author of several novels, including:  Stan’s Story- the true story of her brother’s accomplishments, it has been compared to the style of Capote, and is currently being rewritten with new information for re-release.  Tangled Minds - a riveting story about a young girl’s bad decision and how it taints everyone’s life around her yet still manages to show that hope is always possible. This novel has been compared to the writing of Steinbeck and is currently being written as a screenplay. This novel will be re-released by Kerlak Publishing in 2009  Brilliant Insanity – released by Kerlak Publishing October 2008  Silent Scream – Released by Lulu.com October 2008- Slated to be made into a movie Yvonne’s Philosophy in Life - “Pay it Forward”: “In this life we all have been helped by others to attain our dreams and goals. We cannot pay it back but what we can do is ‘pay it forward’. It is a simple
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2 Responses to Who Really Killed These Children In Foster Care- The Foster Care Provider Or CPS- The Vote is both Equally Responsible

  1. tamika green says:

    my daughter was murdered in birmingham social services are.at the hands of foster carers she sstained horrendous iron burns which needed to be skin graphed.

    Like

    • yvonnemason says:

      Tamika I am soo very sorry for your loss. A parent should never ever outlive their child. If you would like to share your story here feel free. IF you would like for me to post it as a blog send it to ysam51@yahoo.com – education- and exposure is the key to stopping the abuse, greed and corruption in CPS

      Like

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