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Tag: children

New Investigation: Death of 16 Year-Old Girl, State of Pennsylvania After FDA Warning Was Issued

Written by Sheila Matthews on . Posted in MedWatch, Violence.

Sheila Matthews
National Vice President
www.ablechild.org
(203) 966-8419, Fax (203) 253-0329

Vicky Dunkle
Vice President State of Pennsylvania
(814) 887-9296

Attention: Committee Members of Oversight and Investigations:

Antidepressant Use in Children

Last week Ablechild contacted the Committee Members of Oversight & Investigations to make notification that another child has died as the result of antidepressants not FDA approved for use in children. Ablechild Vice President of Pennsylvania, Mrs. Vicky Dunkle, met with the family of this latest victim, a 16 year-old girl on Friday, September 17, 2004. At the age of 14, their daughter started taking Wellbutrin. Two years later, their daughter hung herself, just 14 days after stopping Wellbutrin.

Mrs. Vicky Dunkle provided them information about the on-going Congressional investigation and the recent FDA warning. The family was unaware of the FDA warnings, and on-going investigations into this antidepressant crisis. This clearly highlights the overall public health crisis and lack of management to provide warnings and detoxification procedures. Having psychiatrists come on television to do damage control for the drug companies is not proper public health management. As this committee investigates this national health crisis, there must be a public health plan established to ensure that the public is fully aware of the investigation and the impact of withdrawal. This does not mean encouraging children to stay on antidepressants or focusing on the dangers associated with not seeking “drug” treatment. Non-drug approaches to depression and other behavioral issues should be encouraged and considered prior to prescribing off-label antidepressants.

This latest victim of drug suicide has left a family very willing to speak out. They were never told of the subjective nature of the diagnosis itself, or the dangers associated with the recommended “drug” treatment. Their daughter hung herself in her bedroom. Mrs. Vicky Dunkle’s help to the family comes with a keen sense of understanding, as her own 11-year-old daughter, Shaina Dunkle, died due to toxic levels of an antidepressant prescribed her that was not FDA approved for use in children.

Mrs. Dunkle has been featured on the Montel Williams Show, as well as other National television and radio programs. She is eager to speak out to protect American children and their basic human and constitutional rights. She has asked the family to report their child’s death to the FDA as soon as possible and contact the members of this Committee.

For more information on the recent FDA hearings regarding antidepressants and suicide in children please visit our website at www.ablechild.org

Black Box Warning on Antidepressants

Written by Sheila Matthews on . Posted in Lawmaking, MedWatch.

Sheila Matthews
National Vice President
www.ablechild.org
(203) 966-8419

Gloria Wright
Vice President State of North Carolina

AbleChild is pleased with the FDA advisory panel’s move to place “black box warnings”, the strongest possible warnings that can be issued, on all antidepressants that have been linked to suicide ideations. The FDA’s hearings appear now to offer hope and healing. During the hearings held February 2 and September 13, frustrated and anguished parents and victims testified as to the horrible acts of violence, suicide, and suicide ideation induced by antidepressant use. According to their testimony, SSRI drugs had the causal effect of perpetrating these terrible tragic reactions on their loved ones. SSRI’s are a class of antidepressants still under investigation for causing suicidal thoughts and acts in children and adolescents. Eight of these SSRI drugs have been banned since last year in the U.K. for anyone under 18 years of age. The FDA never approved the use of these drugs for use in children. These drugs failed to meet the basic FDA requirement for effectiveness, yet were prescribed to children through a loophole called “off label”.

Though this move to place “black box” warnings is long overdue, it is necessary and a welcomed step toward improving the informed consent process. Our organization has regularly requested accountability, which must be required of both the drug companies and the psychiatric industry. There must be a documented informed consent process prior to treatment. Our organization will continue to work with the Congressional Investigation and Oversight Committee and FDA to ensure that the wording on warning labels are clear so there is no chance for misinterpretation.

Misinformation is itself a clear and present danger to the safety of our children. We need to focus closely on ensuring any write-ups regarding risks are straightforward, clear, and are not in any way additional attempts to mislead the public further on the part of drug companies or the psychiatric industry. The decision of the advisory panel to place a “black box warning” on these drugs will go a long way towards reducing the suicide rate in the United States .

Ablechild’s president and co-founder, Patricia Weathers testified before the Advisory Panel, “It broke my heart to see so many senseless deaths. To hide this important information from the public is a deadly secret we cannot afford to keep any longer. These families trusted the psychiatric and drug industries, and that trust was broken.”

AbleChild will attend the Connecticut Statewide Conference on Inclusion in New Canaan , Connecticut , on Saturday, October 2. We will offer the Connecticut Department of Education, parents, children’s advocates, as well as educators access to the latest information on the advisory panel’s recommendations and highlight the importance of “The Child Medication Safety Act” which is still stalled in committee in the Senate. For more information, please visit our website: www.ablechild.org.

FDA Update on Review of Antidepressants Used as Tool for Drug Companies to Seek Pediatric Approval for Antidepressant Use in Children

Written by Sheila Matthews on . Posted in Articles.

Patricia Weathers
President
www.ablechild.org
(845) 677-8115

Sheila Matthews
National Vice President
www.ablechild.org
(203) 966-8419

 AbleChild.org Requests that the FDA Withdraw Antidepressant Drug Applications that Seek Drug Approval at Upcoming Advisory Review Committee Meeting on September 13th and 14th, 2004 in Bethesda, Maryland.

According to the FDA’s Talk Paper on the safety review of antidepressants dated August 20th, there are findings among drug trials that suggest an increase risk of suicide in children, but interpretation of these findings represents a “substantial challenge”. Despite these findings, and the fact that the UK last year banned the use of 8 of these antidepressants for use in children, the FDA has attached to their Talk Paper, applications from drug companies, which seek to approve these same drugs for children. (See link attachment on FDA Talk Paper http://www.fda.gov/cder/pediatric/Summaryreview.htm).

The fact is that these drugs have never been approved for use in children. These drugs were being prescribed in what is termed an “off-label loophole”, whereby a doctor could prescribe any of these drugs for a child at his own discretion.

With these facts, and the link to suicide in children, the America public should be alarmed that the FDA is allowing these drug applications to be considered during this safety review process.

“As part of its commitment to keep the American public fully informed about the status of its review of data concerning the use of antidepressants in pediatric patients, the FDA is issuing this update to provide healthcare providers and patients with the most current information on this topic.”

How is this statement fulfilling the FDA’s commitment to fully inform the public, when in fact, they are simultaneously submitting new applications from various drugs companies that would approve the use of these same drugs for children? There was a total of 203 press alerts across the wires yesterday on the FDA’s Safety Update on Antidepressants, all of which excluded the “fine print” located at the bottom of the FDA’s Talk Paper that links new applications to the safety review process. Is this the FDA’s commitment to fully inform the American public?

“The FDA will assure that the labels of the antidepressants used in pediatric patients reflect the most recent information obtained from these same studies and analyses”.

Let’s get to the plan at hand. Is it the intent of the FDA to approve these suicide-linked drugs for use in children, and then slap warning labels on the package after approval?

The September FDA Advisory Committee Meeting that is conducting this review should be acting in accordance with U.S. Code Title 42: Section 289a-1: Part H – General Provisions regarding review and approval of proposal for research under Section (b) Ethical Review of Research. This Advisory Committee has an obligation to the protection of human research and under section (2) the peer review and in the case of any proposal for the National Institutes of Health to conduct or support research; the Secretary may not approve or fund any proposal that is subject to technical and scientific peer review.

Based on these procedural safeguards and guidelines, these antidepressant drug applications that seek drug approval for use in children should be withdrawn immediately from the September FDA Advisory Committee Meeting Agenda.

As a public health agency, the FDA must protect public health, not manage risks associated with depression that goes untreated, especially when that “treatment” itself is inducing suicide ideation that results in death.

It appears the pending strategy seems to be, approve the drugs for use in children, and then warn of risks. This is unacceptable.

GUEST OPINION: Universal Mental Health Screenings: A Call to Rally

Written by Able Child on . Posted in Interviews, Lawmaking.

By Penny Pullen, former state rep and President of Eagle Forum of IL.

OPINION — A recent letter-to-the-editor writer first asked how such an invasive law as Illinois’ new universal mental health screening atrocity could be passed, and then answered, essentially, that anything can pass any time if it’s characterized as being “for children.”

This may be true today, sad to say, but once upon a time, it was not. And so, I’m not so sure it is true.

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Ablechild Petitions Connecticut Governor And Public Health Commissioner To Provide Public With FDA Warning On Antidepressants Before Treatment

Written by Sheila Matthews on . Posted in Lawmaking, MedWatch.

Patricia Weathers
President
www.ablechild.org
(845) 677-8115

Sheila Matthews
National Vice President
www.ablechild.org
(203) 966-8419

 AbleChild has learned that last week the Connecticut Commissioner of Public Health, Dr. Galvin, submitted to Governor Rell a written opinion on Informed Consent relating to the recent FDA Antidepressant Warnings and their link to Suicide in adults and children. Ablechild requests that the office of Public Health, as well as the Governor’s office, provide this written opinion on informed consent to the public immediately, to ensure that the public is aware of the ongoing investigation and public health warnings regarding antidepressants and the implications surrounding this issue.

This year FDA warnings on Antidepressants immediately followed an FDA investigation, which was launched on a different class of antidepressants known as SSRI’s (Selective Serotonin Reuptake Inhibitors). This investigation and subsequent warnings comes after the United Kingdom banned the use of SSRI’s in 2003 for anyone under age 18, due to their propensity to cause suicidal ideations in children and adolescents. Currently the FDA has required that the drug companies re-label antidepressants with stronger warnings, requiring them to disclose their links to suicide.

This past week, on the Federal level, a Congressional Investigative Subcommittee Hearing, which was to investigate drug companies’ concealment of clinical data involving harm and negative side effects of Antidepressants, was abruptly shut down. This shut down, was a result of the Subcommittee Chairman’s (Congressman Greenwood-PA) acceptance of a job with one of the company’s under investigation. This recent news highlights the corruption within the political process, and the conflict of interest, both of which have sadly overrode our children’s health and safety.

In light of these facts, Ablechild has taken immediate action in Connecticut to increase public disclosure of the very real risks and life threatening warnings that these drugs have, in hopes of dispelling the myth that these drugs are safe and effective. Misinformation, comprising of the idea that these drugs are safe for our children, has been for many years, all too easily and eagerly, spread by the pharmaceutical industry manufacturing them, as well as a major portion of the mental health industry. Both of these industries have vested financial interests as top priority.

The State of Connecticut has a responsibility to protect public health. The public needs to have access to all warnings in order to make informed decisions regarding whether or not to use antidepressants for “treatment”, being recommended for depression and other psychiatric labels placed upon our children. These warnings need to be taken seriously, should be disclosed readily prior to “treatment”, and should not be overlooked. Informed Consent, hand in hand, with public safety, should be everybody’s top priority!

To read more on antidepressant warnings visit www.ablechild.org

Victims of Antidepressants Respond to Federal Corruption in Ongoing Investigation. Drug Companies’ Influence Suspends Hearing.

Written by Sheila Matthews on . Posted in Lawmaking, MedWatch.

Patricia Weathers
President
www.ablechild.org
(845) 677-8115

Sheila Matthews
National Vice President
www.ablechild.org
(203) 966-8419

 A hearing scheduled for yesterday, July 20, 2004, by the House Energy & Commerce Subcommittee on Oversight and Investigations, headed by Congressman Greenwood of PA, was abruptly shut down just hours before it was to convene. This hearing, requested by victims, was scheduled to address both the withholding of clinical trial data from the public by drug companies, and the role of the FDA in the antidepressant investigation. Representatives from 7 pharmaceutical companies, their trade association, as well as, representatives from the American Medical Association, the American Academy of Pediatrics, and one top FDA official, were all scheduled to testify before the Subcommittee. Ablechild learned from the Associated Press that the hearing was suspended due to Congressman Greenwood’s announcement that he was seeking career opportunity from the pharmaceutical industry. This clearly raises ethical concerns.

Ablechild received a flood of calls from families outraged over the government’s depraved indifference to human rights, its lack of responsibility, and its blatant disregard for the public safety. Ablechild has put in an emergency request to the Senate to reopen these hearings to the public immediately, due to this Subcommittee’s inability to act in the best interest of the public. Parents contacting Ablechild know that the Subcommittee is unduly influenced and request that immediate action should be taken to uphold the integrity of this investigation.

On behalf of parents nationwide, Ablechild contacted Senator Santorum, from PA, specifically requesting that he take steps to reopen these hearings to ensure that the health and well being of our children is not, in any way, compromised. Ablechild points to the death of little Shaina Dunkle, from Pennsylvania, who at the age of 10, died from the direct result of antidepressants. Mrs. Vicky Dunkle, has repeatedly appealed to both Congressman Greenwood and Senator Santorum, asking for accountability in the death of her daughter. We have appealed to Pennsylvania, reminding them that Shaina Dunkle’s death should not be disregarded by the power plays of special interest groups influencing politicians and investigative hearings.

The government has the responsibility to protect public safety. Ablechild eagerly awaits Senator Santorum’s response.

National Association of School Psychology Down Plays Drug Deaths and Misleads Public on State Laws On National Public Radio

Written by Sheila Matthews on . Posted in Lawmaking, Violence.

Patricia Weathers
President
www.ablechild.org
(845) 677-8115

Sheila Matthews
National Vice President
www.ablechild.org
(203) 966-8419

 In a NPR radio segment on the Here and Now show that aired yesterday, the National Association of School Psychology Spokesman, Peter Welley, told the public that Connecticut’s law that prohibits school personnel from recommending psychotropic drugs for children was rescinded. Connecticut’s legislation signed into law on June 28, 2001, has served as model legislation for other states around the country. Peter Welley, speaking on behalf of the organization for school psychologists, further indicated that there were many complaints launched against the Connecticut legislation.

Ablechild.org knew this public claim aired live was an outright falsehood. We suspected it to be an outlandish and meager attempt at best, to mislead the public by steering it away from the fact that this nation has been passing legislation in order to counter the epidemic of children being forced onto drugs via the public schools. Ablechild immediately launched its own investigation into this serious matter by placing a direct call into Republican Lenny Winkler’s office, the Sponsor of the Connecticut Law, as well as a practicing emergency room nurse. Her office confirmed our beliefs by assuring us that the law has not been rescinded, or in any way changed. Furthermore, AbleChild.org has learned from their office that the only complaints that they have received regarding this legislation, were from, not surprisingly, The National Association of School Psychologists. Questioned more in depth, Representative Winkler’s office indicated to us that there was not one parent complaint.

There could be several motivating factors, which prompted this organization to misrepresent the facts publicly. The possible loss of grant money is just one incentive for continuing today’s trend of labeling and drugging our children. Ablechild suspects that there will be many more similar attempts to misrepresent and divert public attention by organizations that have preyed off of our children for many years. These group’s financial incentives are on shaky ground, and it is not surprising that they grasp at thin air, in lieu of so many facts arising to the public nationwide regarding legislation and drug risks. It could be that the nation’s widespread anti-coercion Federal and State legislation, Great Britain’s ban last year of the use of 8 different antidepressants for children and adolescents, America’s own on-going FDA investigation and warnings on antidepressants, and the many Federal legal cases pending regarding informed consent and drug risks, all had a hand in making many groups a tad bit jumpy.

Children’s health and safety are being compromised daily and The Association of School Psychology takes no responsibility for this reality associated with their diagnoses and recommendations. This is a national mental health crisis, and confirms the fact that we need Federal protection in place for our children. To read about the current Federal Legislation called “The Child Medication Safety Act” and to help ensure a child’s right to grow up healthy and drug-free click here  Legislation.

Access Denied to Parents in Public Schools – A National Crisis on Informed Consent

Written by Sheila Matthews on . Posted in Lawmaking.

Patricia Weathers
President
www.ablechild.org
(845) 677-8115

Sheila Matthews
National Vice President
www.ablechild.org
(203) 966-8419

 May 19, 2004, a national news story ran out of Connecticut regarding a 7-year-old child that attacked a teacher, after he would not stop tapping his pencil. The school called in the police to subdue the child. The fact is, that this isn’t the first problem Stratford Elementary School has had with its teaching style and psychological services.

On February 12, 2004, Connecticut Stratford Police were called to Nichols Elementary School when a mother of an 8-year-old boy told police that the school administrators physically abused her son who had been diagnosed with the subjective label “ADHD”.

Ablechild.org contacted both the elementary school and the Stratford police department to request that information on the current federal Investigation into the use of behavioral drugs for children, be provided to both parents with children involved in the recent acts occurring at the school. Ablechild.org stressed to the police department the importance of providing this information to the parents to ensure that they were given proper informed consent. The Stratford Police department, though sympathetic to our request, referred us to the board of education, which outright refused our organization’s request. We strongly urged the board to provide information to the parents on the current federal investigation into the dangerous drug ‘treatment” for the controversial label “ADHD” to comply with full informed consent.

This raises serious questions regarding the lack of information parents are receiving about the label “ADHD”, behavioral drugs linked to bizarre behaviors, and suicide ideations in children that are currently under review on the Federal level.

On May 17, 2004 CBS 11 out of DALLAS-FORT WORTH Report By Investigator Ginger Allen and Producer/Photojournalist Dave Manoucheri revealed that, “Medicating children to control behavior has become a trend over the last decade, but now drug manufacturers and even the U.S. government are in the hot seat, questioned about a potentially deadly side-effect of what is supposed to be a life-saver.”

Informed consent is such an important part of the decision making process for all parents. This is a national crisis when 7 and 8 year olds need to be restrained by the police. It is time we look at the psychological programs at these elementary schools to ensure that proper informed consent is occurring.

Is 8 Year-Old Boy Victim of ADHD Fraud?

Written by Sheila Matthews on . Posted in Articles.

Patricia Weathers
President
www.ablechild.org
(845) 677-8115

Sheila Matthews
National Vice President
www.ablechild.org
(203) 966-8419

Connecticut-Channel 12 News Report of 2/11/04 out of Stratford, Connecticut entitled “Allegations of physical abuse at Stratford Elementary School” reported that Stratford Police were called to Nichols Elementary School on charges of abuse by school personnel. The mother of the 8 year-old boy, Marsh Davis, told the Stratford police that her son was physically abused by the school administrators. Channel 12 News reported that the boy was said to be suffering from the controversial label “adhd”.

Our organization, www.ablechild.org contacted the parties involved in this news report: Connecticut Channel 12, The Board of Education of Nichols Elementary, and the Stratford Police Department to request that Marsha Davis, the legal guardian of this child be given proper informed consent regarding the subjective label of “Attention Deficit Hyperactivity Disorder”. This must be done to ensure that her and her child’s basic rights of “informed consent” and the “right to refuse” at the time of the diagnosis was properly followed. We simply asked to provide Ms. Davis with our organization’s name. The Stratford Police Department told us to contact the board of education. Channel 12 and the Board of Education have been contacted by our organization and have not yet responded.

Marsha Davis must have access to the latest legislative actions on the local, state, and federal level regarding the over-identification of children, the right to refuse, and the one directly in question here, “informed consent”. Information must be provided to the parent on the controversial nature of the label “adhd”. This is of the utmost importance so that the legal guardian making decisions on that child’s behalf can make an informed decision to ensure the safety and well-being of the child.

The bottom line, we all need to find out what this mother “was told” about “adhd” and by whom. All parents deserve accurate information on the labels that are marketed to our children.

50,000 Children Taking Antidepressants

Written by Able Child on . Posted in Articles.

Sarah Boseley, Health Editor, The Guardian

· Drug withdrawn over fears it made youngsters want to kill themselves
· New questions for pharmaceutical firms

An antidepressant which GPs have been prescribing to thousands of children, in spite of the fact that it is not recommended for their use, can cause youngsters to want to kill themselves, the government’s regulatory agency warned yesterday.

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