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Will the FDA Follow Guidelines For Safety Review of Antidepressant Use In Children?

Patricia Weathers 845-677-8115

Sheila Matthews 203-966-8419
National Vice President

The FDA’s hearings on February 2, 2004, regarding the safety review process of today’s mass marketed antidepressants otherwise known as SSRI’s (Selective Serotonin Reuptake Inhibitors) has led us to question what guidelines are being followed by the administration that would ensure due process in obtaining a determination that will affect our children’s overall health and well being.

February 2, 2004 marks the day that parents and children implored the FDA to listen to their stories of personal tragedies regarding antidepressants and view them as a wake up call, one that would require immediate action. Sadly, parents need a hitter, but the administration appears to be lingering on the sidelines stating that it would not be making a decision anytime soon.

Parents might have to wait a dangerously long period-of-time for the administration to give a final answer, which possibly could occur sometime in late summer. Until then, the FDA has advised doctors to use great caution if they prescribe any antidepressants to anyone under age 18. This is unacceptable.

The FDA must be held accountable for following guidelines regulating the safety review process that governors what they can and cannot do and their ability to move forward in an unbiased manner in addressing the emerging issues related to drug development, testing and safety. The FDA needs to adhere to the United State Code – Title 42, Section 289a-1: Part H – General Provisions regulating any and all actions that need to be taken regarding safety review of drug research.

Is the administration on the same page with us regarding the guidelines that govern the review process?

Parents look to specific written rules that govern the FDA’s safety review process that relates to drug research outlined within US Code 42, Section 289A-1, Part H: General Provisions. As with free elections, the public must be able to rely on some type of written rules to ensure the process is open and reliable.

Under US Code 42, parameters are in place regarding how the FDA can act. One such area is the FDA’s choice of a review panel. The composition of this panel or “the ethics board for review” should consist of specific review panel members. The public should be aware that there should be in place at least one attorney, a minimum of one ethicist, at least one practicing physician, one theologian, and no less than 1/3 and no more than 1/2 of scientists with substantial interest in biomedical or behavioral research. The translation of this should be quite clear: The FDA cannot arbitrarily choose just anybody for this review panel.

Within the general guidelines, there are also time sensitive dates, such as- an ethics board termination schedule, that must be highlighted in lieu of the FDA’s announcement that they will not be able to give an outcome any time soon. Parents are concerned that the FDA is bypassing time sensitive dates and the structural make-up of the review board in hopes of protecting special interest groups. The safety reviews are governed by due process and parents expect the administration to hold our children’s basic safety above special interest group agendas.

The FDA should be held accountable for informing the public as to how they will proceed under the federal guidelines clearly set-up to govern their actions. At the very least, they should inform the public as to which type of review will take place according to these provisions.

The FDA stated in its recent memorandum:

“The FDA relies on the knowledge, judgment, experience, and wisdom of scientists and practitioners like you to help determine how to move forward and address newly emerging issues related to drug development. We thank you for your time and effort, and we look forward to seeing and hearing from you on Feb 2nd.”

This closing statement, we believe, clearly demonstrates the administration falling several feet short of meeting the expectations outlined within the US Code. We question the FDA’s actions and ask it to supply the answers to show that it is operating within the guidelines that regulate the safety review process. After all, the public is entitled to know if the FDA is following this basic safety review process outlined within the U.S. Code.

It is very clear to us what the FDA needs to do and the parameters that regulate how they need to do it. In the same token, is it clear to the FDA?

Children and Parents To Go Before the FDA

Contact Information:
Patricia Weathers: 845-677-8115
Sheila Matthews: 203-966-8419

Victims of the massed marketed antidepressant industry will go before the FDA on February 2, 2003 to place on the record their own personal tragedies of violent behaviors, induced suicide, and deaths associated with the use of antidepressants in children. These parents and children will attempt to get the FDA to recognize the very real dangers that can occur when using many of today’s SSRI’s, also known as Selective Serotonin Reuptake Inhibitors. The overall hope of these victims is that the FDA will step up to the plate, in much the same way as the UK recently did, by delivering a no nonsense blow to the pharmaceutical industry, altogether banning all but one SSRI for use in children. At the very least, parents hope that the FDA will take some constructive action to protect children in the U.S. Sadly these hopes are being questioned, in lieu of the FDA’s recent choice of a panel review committee with some members clearly tied into the pharmaceutical industry itself.

Just weeks before these hearings, a new study appeared in the printed media. The psychiatric industry uses statistics in its latest attempt to debunk the link between antidepressants and suicide. Even the New York Times has questioned the release and validity of such a study and questions the timing of its release.

The end result is, that no matter how you twist and turn the numbers, one thing that cannot be explained away is the violent behaviors, and in some cases even deaths associated with the use of antidepressants. Parents are in for a bumpy ride, clearly up against the billion dollar psychiatric and drug industries choke hold on an overwhelmingly unsuspecting American public. The question is; will the FDA ask the psychiatric industry to support its latest claims with actual evidence, or will it play the numbers game as well? Parents will fight for answers not just numbers. They ask for accountability in hopes that the profits on Wall Street do not override the safety of our future investment, our American Children. Our organization proudly supports the parents that go before the FDA and take a stand for children. For more information, please visit

When the State Takes Your Child

Contact Information:

Patricia Weathers
(845) 677-8115

Sheila Matthews
National Vice President
(203) 966-8419

The Asplund’s nightmare began when Chucky was eleven and the school diagnosed their son as emotionally disturbed and ADHD. The State took custody of Chucky when the Asplund family refused to administer behavioral drugs to their son. Chucky Asplund spent March 16, 2000 to August 24, 2001 in State Custody. As Ward of the State, the State of Connecticut administered four drugs: Welbutrin, Haldol, Ativan, Risperidal; drugs not FDA approved for use in children.

The Asplund have requested that Representative Hetherington on the Program Review Committee in the State of Connecticut investigate the current policies regarding children mandated into State care, as well as what the Asplund’s believe is their participation in clinical drug trials without proper informed consent. Overall, the Asplund are seeking accountability and a full investigation by the State into the amount of children on behavioral drugs with little or no oversight.

“I believe my son, Chucky, was used in a clinical drug trial for Welbutrin. The doctor told me they needed children for the drug trial. I never wanted him on any of the drugs. I never gave my informed consent. My child was trapped in the system and we had no say,” said Lynn Asplund.

The result was that the State of Connecticut released Chucky from the Department of Family Services in March of last year. Lynn Asplund asserts that she will stand firm and fight this outrage; one that she believes violated her and her child’s civil rights.

“I plan on fighting back now that my son is home! We have a right to know if he was used in a clinical drug trial. We have to protect our children from this kind of abuse. Our hope is that Chucky’s ordeal will prevent children that are mandated into State care from being used as human guinea pigs in clinical drug trials or from being forced into taking drugs against their parent’s wishes,” Lynn Asplund said.

The Asplund’s fight to regain custody of their son took them in front of the State Legislature to pass the first State law of its kind to prohibit schools from recommending behavioral drugs for children and the removal of a child from their home based solely on the fact that the parents refuse to administer these behavioral drugs. Currently six other States have follow Connecticut ’s example and passed similar laws. Another 13 have some form of legislation pending or resolutions in place. This clearly demonstrates that the problem is nationwide.

This crisis and outcry from parents has prompted the Federal government to take action by introducing this year “The Child Medication Safety Act”. This act is an anti-coercion bill stating that schools cannot coerce parents to “medicate” their children as a requisite for attending school. This bill passed the House of Representatives 425 to 1 and is currently pending in a Senate committee. The overall goal is that this bill will protect all children in all States from being forced into behavioral drug use.

For more information on “The Child Medication Safety Act” or statistics by State of parents coming forward with similar cases, visit

Reaching Out to Educators and the Public Attends Connecticut’s State Education Conference on October 25th, 2003 Entitled “Inclusive Education: Promising Practices”

Board of Education Candidate, Tucker Murphy visits Sheila Matthews and Patricia Weathers of showing her support for the National Parent Organization “Movement”
Table Display
Woman signing member list supporting
coercion petition
Table Display
 AbleChild with Wayne Hollings, Head School Psychologist for the New Canaan School District. He supports ‘The Child Medication Safety Act.’ AbleChild with Special Education Attorney, Anne Eason

Connecticut’s Senator Dodd Refuses Parents call to Co-sponsor “The Child Medication Safety Act of 2003”

Contact information:
Sheila Matthews                (203) 966-8419
National Vice President

The national grassroots organization, AbleChild: Parents for Label and Drug Free Education ( announced that Connecticut’s Senator Dodd has refused to co-sponsor Senate Bill 1390, “The Child Medication Safety Act of 2003”. This anti-coercion bill would ensure that schools, operating under federally funded programs, do not demand that a child be “medicated” as a requisite of attending school.

Dodd’s refusal to co-sponsor this bill was highly disappointing to the national parent organization, particularly given the fact that Connecticut was the first state to implement legislation prohibiting parents from being coerced to drug their children. Subsequently, Connecticut set the precedent for parents’ rights, prompting 6 states to pass similar legislation and the U.S. House of Representatives to pass the Child Medication Safety Act by 425 to one.

While certain mental health vested interests have tried to say the issue of coerced child drugging is “anecdotal”, AbleChild: Parents for Label and Drug Free Education say that this is simply a diversionary tactic — meant to minimize widespread systemic abuse. The organization has gathered over 400 signatures from parents across the U.S. who attest to the fact that they personally have been pressured, coerced or forced to administer psychiatric drugs to their children as a pre-requisite for attending school.

Ms. Sheila Matthews, the National Vice President of AbleChild: Parents for Label and Drug Free Education, said that Senator Dodd’s office was made aware of these 400 signatures. “I personally contacted Senator Dodd’s office and informed them that our grassroots organization, with very little promotion other than word of mouth, gathered over 400 signatures of parents from across the country who have experienced this abuse. We have parent’s signatures that are from states, which have in fact passed legislation prohibiting schools from coerced drugging, yet the pressure continues because there is no set accountability for violations of these laws. This fact is exactly why we need federal protections — because there must be accountability — there must be financial penalties for federally funded agencies, namely schools, that completely disregard a parent’s right to raise their child drug free.”

Surprisingly, Senator Dodd said in his recent press release on the Drug Trafficking Grants awarded to the City of Norwalk, “No amount of money can do as much as a caring parent, teacher or neighbor to prevent kids from falling into unhealthy behaviors that include violence and substance abuse”. Sadly, Senator Dodd has failed to hear the cries from those “caring parents” asking for assistance in co-sponsoring this important bill, which directly relates to controlled substances.

AbleChild encourages all Connecticut residences to stand up for those who don’t have a voice, and urge Senator Dodd to sign on as a co-sponsor to this landmark legislation, so that every parent has the inalienable right to refuse to administer potentially addicting, dangerous and even life threatening drugs to their children. This organization has members whose children have died due to coerced psychiatric drugging, and as parents, they stress that we simply must not allow this abuse to continue.

To find out more about child abuse and child death from coerced child drugging, log onto and read the testimonies of Mr. Larry Smith, Vice President for AbleChild Michigan, and Mrs. Vicky Dunkle, Vice President for AbleChild Pennsylvania. The petitions signatures are also available for viewing.

50,000 Children Taking Antidepressants

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.

Continue reading

Death of Daughter Drives Parents to Washington D.C., Seeking Senate support of “The Child Medication Safety Act of 2003”

Contact information:

Sheila Matthews
National Vice President, 203-966-8419
Parents for Label & Drug Free Education

On February 26, 2001 , at the age of 10 years old, Shaina Louise Dunkle died within minutes in her mom’s arms, due to toxic levels of the psychiatric drug prescribed her. Mr. and Mrs. Dunkle never wanted to drug their daughter, but continued pressure from school personnel to have their daughter diagnosed for “ADHD” led to them to accede to the pressure.

Mr and Mrs. Dunkle are now passionately campaigning for safeguards against coercive tactics in public schools, that pressure parents to have their children diagnosed for “mental disorders” and seek out drug treatment. They are bringing their own tragic story to members of the U.S. Senate, in an effort to illustrate the need for federal safeguards to protect other parents across the U.S. from being coerced, pressured or forced into administering potentially addictive, dangerous and even life-threatening psychiatric drugs to children.

According to Mrs. Vicky Dunkle,”Parents are being misled into believing they are doing right by their children when agreeing to administer psychiatric drugs to them. They do not realize that they are harming them. The fact that school personnel can coerce parents into administering these dangerous drugs to children has got to stop. Schools are supposed to be the place that we, as parents, feel our children will be safe from harm. Our daughter’s death has not only left us to deal with the guilt of believing in the so-called professional system, but anger that we were not warned properly about the subjective label and the risks of the ‘treatment’ associated with it.”

Mrs. Vicky Dunkle is now the Vice President for the state of Pennsylvania of Parents for Label and Drug Free Education,, a national grassroots parent’s organization that fights for a parent’s inalienable right to raise their children drug free. The group has over 350 signatures on their website from parents across the nation who have been coerced, and or pressured by school personnel to drug their children. She and her husband Steve Dunkle are in Washington D.C. this week, speaking out on behalf of the hundreds of other parents who support the “The Child Medication Safety Act of 2003”, Senate Bill 1390.

With recent headlines alerting the Nation of the banning and warnings regarding the drug Paxil for its potential for causing suicidal ideation in children, the makers of the drug Efferxor, have now admitted that their drug has similar deadly risks for our children. This new evidence highlights the urgent need for both a federal response and immediate action in what is a serious threat to children’s safety.

Today marks the 33rd Year Anniversary of Federal Hearings held on Behavior Modification Drugs on School Age Children – The Right to Privacy Inquiry. 91st Congress, Second Session

Contact Information
Patricia Weathers      (845) 677-8419
Sheila Matthews         (203) 966-8419

Thirty-three years later, parents continue to be pressured by school officials to place their children on mind altering behavioral drugs. Today, parents have come together across the Nation to ask the Senate to move “The Child Medication Safety Act of 2003” into law. This problem of labeling and drugging school age children has not been solved. It is time we look at the long history of this dangerous problem and close the loopholes that allow it to continue to grow.

Let’s remember that during the 1970 hearings, The U.S. Department of Health, Education, and Welfare, Public Health Service, Food and Drug Administration of Washington, DC issued for immediate release the following: “Dr. Charles C. Edwards, Commissioner of the Food and Drug Administration, said today he has moved to limit sharply the use of amphetamine drugs, now, being widely sold as stimulants and appetite suppressants in this Country, and he appealed to manufacturers to reduce the production and sale of these drugs.”

This reduction demand has not happened. The fact is that the production and sales have increased. These important hearings into the use of behavioral modification drugs should be remembered today. Our Country must be allowed educational access to the history of the problem. This problem still clearly exists. A positive step would be to move “The Child Medication Safety Act of 2003” into law.

It is unbelievable to see an article from the Washington Post, September 30, 1970, FDA Warns against Uses of “Behavior” Amphetamines, By Robert C. Maynard; and to think it is 2003 and parents are still fighting for justice


Sheila Matthews
Parents for Label and Drug Free Education
National Vice President

White Plains, New York: Federal District Judge Conner

Motion to Dismiss Denied.

United States Federal Judge of the Southern District of New York, Judge William Conner, has ruled coerced child drugging case will stay in federal court. Senior District Judge denies motion to dismiss.

On August 7, 2002 little 12 year-old Michael Mozer’s horror story of school officials forcing him “To take a cocktail of drugs that turned him into a psychotic who heard voices in his head” hit the front cover of the New York Post. School officials, “Who went so far as to file a medical-neglect and child-abuse complaint against his mother with the State’s Department of Children and Family Services after she stopped the medication,” have lost their plea to have the case dismissed.

New Jersey lawyer Alan Milstein of Sherman, Silverstein, Kohl, Rose & Podolsky ( is handling this high profile case. Milstein raises the issue of informed consent and the claims that parents are not being provided with all information regarding the subjective nature of an ADHD diagnosis, alternatives to “medication”, and drug risks, among others. Milstein’s focus is also on the constitutional rights of the child.

Both the school and doctors’ attorney filed motion to have the legal action dismissed earlier this year. In an eleven page opinion and order of July, 2, 2003, Judge Conner ruled that this boy’s case will indeed be heard in federal court, officially dismissing the school’s and physicians’ attempts to get it thrown out.

This case has a national impact and has the power to reform the broken system of labeling and drugging children within the public education system.

“No child should endure what Michael Mozer has been through. With more and more legal cases pending, this should serve as a wake up call to ensure our children will not be trafficked into behavioral drug use through the public education system,” Sheila Matthews, National Vice President

The sweeping trend of States passing laws to prevent forced drugging in the public schools, and Congress passing similar legislation in the form of the “Child Medication Safety Act of 2003” with a margin of 425 to 1, has led Senator John Ensign of Nevada to sponsor this Act in the Senate.

For further information on the legal aspects of this case contact Alan Milstein,

Reference: New York Post Article by Douglas Montero, August 7, 2002.

Behind Closed Doors Drug Company Lobbies Connecticut DCF Officials For Access to Children in State Care

Sheila Matthews
National Vice President
State of Connecticut is outraged that the Commissioner of the State Department of Children and Families (DCF) meets behind closed doors with the manufacturer of the drug “Paxil” that has been linked to suicidal thoughts in children without any oversight. This raises ethical questions.

The FDA has warned that “Paxil” should not be used in children, and the United Kingdom has banned its use. In November 2002, Fox National News exposed confidential documents from the manufacturer of “Paxil” which suggested that a patient taking the drug was 8 times more likely to commit suicide then a patient on placebo (sugar pill).

In Connecticut in May of 1997, GlaxoSmithKline Pharmaceuticals-Biological Division sponsored Workshops in Connecticut on Strategies for Drug Development and Trials in children at Yale Department of Pediatrics, and Yale Child Health Research Center in New Haven, Connecticut as well as Yale Child Study Center. What role does DCF children play in clinical drug trials?

The Associated Press exposed that 396 children under 4 years old who were covered by Medicaid were prescribed psychiatric drugs. The Associated Press also reported that $5.8 million in state Medicaid money was spent each year on psychiatric drugs for children with State insurance.

It is shocking that DCF, who has a total lack of accountability for previous involvement in the trafficking of children in State care into behavioral drug use, is meeting directly with the drug manufacturer of “Paxil” without any oversight. The Governor wasn’t even informed that the meeting was held yesterday, no minutes of the meeting were taken, and the purpose of the meeting was not disclosed.

However, our organization was told by DCF that the foreign-based drug manufacturer has been invited to participate in upcoming policy meetings on psychotropic drugs in September within the Department of Children and Family Services in Connecticut. Our Connecticut children in DCF care lack basic education, yet we are spending massive amounts of money on behavioral drugs. This is unethical. We have a shortage of basic access to tutoring that is sorely needed for children in state custody.

It is like putting the fox in charge of the hen house. The children’s safety, well being, and their basic constitutional rights should force the closed doors open. Our Connecticut based National Parent Organization, Parents for Label & Drug Free Education; has requested access and oversight, which we have not received.