Skip to main content

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.

PBS FRONTLINE Markets Misleading Information to Public Schools on Columbine School Shootings

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

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

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

In a Frontline PBS documentary style marketing pitch that aired on May 13, PBS simply misleads viewers by attempting to justify the profiling of boys through checklists to predict violent behavior. PBS has failed to mention the fact that Littleton, Colorado had in place a psychological education program, which first came to Littleton in 1991 under the name “outcome-based education”. This million dollar psychological based program was in place prior to the school shootings and failed to prevent the very violence that occurred. PBS is marketing this misleading information for a fee to school officials.

Let us not forgot that Eric Harris enrolled in a psychological school based program called, “Conflict Resolutions” and was on a drug called Luvox. In a Special Report, Perscription Drugs May Trigger Killings, human rights award-winning reporter, Kelly Patricia O’Meara wrote, “The physician’s desk reference (PDR) records that, during controlled clinical trials of Luvox, manic reactions developed in 4 percent of children. Mania is defined as “a form of psychosis characterized by exalted feelings, delusions of grandeur…and overproduction of ideas”. Court records show that the prescription for Harris had been filled 10 times between April 1998 and March 1999, and that three-and-a-half months before the shooting the dose had been increased- a common thread many experts say they are finding prior to adverse reactions to psychotropic drugs. The autopsy on Harris revealed a “therapeutic level” of Luvox in his system.”

O’Meara’s Special Report stated, “Other school shooters on antidepressants at the time of their attacks include 15 year old Kip Kinkel who, while on Prozac, killed his parents and then proceeded to school where he opened fire on classmates, killing two and wounding 22 others; 14-year old Elizabeth Bush, on “antidepressants” when she wounded one student at Bishop Neumann High School in Williamsport, PA; and 18 year-old Jason Hoffman, on Effexor and Celexa when he wounded one teacher and three students at Granite Hills High School in El Cajon, CA.”

B.K. Eakman, Executive director of the National Education Consortium and author of “Cloning of the American Mind: Eradicating Morality Through Education”, writes in an Washington Times Op-Ed piece on Monday, April 26, 1999 following the Columbine shootings. “Last week the cumulative effect of therapeutic/socialization-style education hit critical mass. Parents in Littleton, Colo., got a good jolt of the “mental hygiene” approach to schooling, up close and personal. Drug education, refusal skills, self-esteem, and relationships became the centerpieces of the curriculum, pushing academics to the back burner.”

Rewriting history and leaving critical information out so that the public cannot make informed decisions regarding the funding and potential classification and profiling of children within the public education system, is criminal. For Frontline to market this junk science to public schools is an outrage.

While we applaud Kevin Dwyer, the President of the National Association of School Psychologists for criticizing the number of checklists and expressing concerns regarding profiling, labeling, and stigmatization of children, we would like to point out that he failed to address the involvement the National Association of School Psychologists had in the role at Columbine. His association, The National Association of School Psychologists, also opposes, “The Child Medication Safety Act”, an anti-coercion bill to protect against forced drugging of children.

Our organization calls on the United States Government to prevent misleading and dangerous information from entering our public schools. This is a public health issue on the National level. For more information on the crisis regarding behavioral modification drugs visit www.ablechild.org.

Ablechild Plugs Loopholes in Trafficking of Children Forced Into Behavioral Drug Use in the State of Arizona

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

 Rebecca Noble, Vice President of Ablechild.org in Arizona secured a big win for parents by protecting their ‘right to refuse’ psychiatric drugs for their children. A new law stating that Child Protective Services (CPS) can no longer charge parents with “medical neglect” for failing to administer psychiatric drugs to their children is a victory for parents. Another bill that would have furthered parents ‘right to refuse’ psychiatric drugs for their children within schools was defeated. This defeat for the right to refuse psychiatric drugs clearly erodes parent’s rights to protect their children’s health and safety and is one more example of why ‘The Child Medication Safety Act of 2003’ is urgent on a federal level.

Last December 3, 2003 Rebecca Noble, Vice President of AbleChild.org, Arizona testified before the Arizona House of Representative, forty-sixth Legislature, in a Second Special Session, Committee on Appropriations in regards to Child Protective Services (CPS) being called on parents unwilling to harm their children by placing them on dangerous psychiatric drugs used to “treat” behavioral or attention issues. Senate Bill 1009 said that CPS did not have the right to accuse parents of medical neglect if that parent chooses not to “medicate” their child.

Ms. Noble worked with Senator Mark Anderson in the Senate and Representative Eddie Farnsworth in the House to ensure that the CPS bill included language to protect parents who refuse psychiatric drugs for their children. They all fought very hard for this language. In the end, House leadership led by Representative Eddie Farnsworth held the line during negotiations with the Governor by saying that the wording of the psychiatric drug clause was “non-negotiable”. On December 13th, 2003, the bill passed both the House and Senate and went to the Governor’s office for a signature. On December 18th the Governor signed HB 2024 into law.

“Parents should be thrilled with this new law guaranteeing that there will be no detrimental action taken against them by CPS, a state abuse agency, that was clearly operating well outside its “abuse” boundaries, said Rebecca Noble, Ablechild.Org Arizona Vice President. “Parents should have a definitive right to say no to all drugs used today to ‘treat’ diagnoses such as ADD/ADHD derived by completing both simple and highly subjective rating scales and checklists. These drugs many times have had severe side effects on a child, and a parent no longer willing to administer a drug based on the harm it has caused their child, should not be threatened with ‘abuse’ charges.”

Ms. Noble pointed out all parents need to be aware that additional legislation that would further protect their ‘right to refuse’ psychiatric drugs for their children was shot down recently. The recent anti-coercion legislation that Ms. Noble referenced was SB 1278, a bill simply stating that parents – not school employees – should make the medical decisions regarding children with behavior problems.

Sadly, Arizona Governor Janet Napolitano vetoed this important legislation and from this clear shot to parental rights, we can all but assume that the Governor believes that schools should be allowed to force parents to drug their children in order to be allowed to attend school.

The governor’s veto had prompted Senator Mark Anderson a champion of parental rights to issue a statement to the press on what he correctly calls the “Eroding of Parental Rights”. In addition to Senator Anderson, there are many key players in Arizona fighting the good fight, that fight for parental and children rights. These players will continue to champion this issue and fight to renew legislation. More effort is needed from Arizona parents to get the message out that there should be no compromises surrounding their parental rights to refuse drugs for their children and that their ‘right to refuse’ should be guaranteed.

Ablechild.org has its own personal experience with both coercion and harm due to psychiatric drugs. It has two members who have had children that have died from drugs forcibly prescribed them. Other members have had children harmed as from the drugs and many have had state abuse agencies called on them as well. As a result, of the widespread mental health systems abuses occurring within and outside the educational system, AbleChild a national grass root organization, was born to crusade for parental rights in the midst of a Nation clearly in crisis.

This crisis itself is schools forcing parents to administer drugs to their children in order to be in a classroom setting. The response to this crisis is that more than 12 States have initiated some form of legislation or resolutions to curb this trend in forced psychiatric drugging. There are seven States, which have laws on the books preventing schools from recommending or demanding that parents place their children on behavioral drugs as a condition for attending school. The Federal Government has even initiated a similar bill in response to the widespread coercion of parents occurring throughout the nation.

This bill “The Child Medication Safety Act of 2003” passed the House of Representatives 425-1. Currently it is pending in the Senate, stalled due to the many special interest groups claiming to have parental rights and children’s safety at heart yet still pocketing pharmaceutical funding. Ablechild.org is just one of the many organizations that have brought this conflict of interest to light to parents nationwide. For more information on this important bill visit www.ablechild.org.

Letter to Connecticut’s Attorney General’s Office.

Written by Sheila Matthews on . Posted in Lawmaking.

March 12, 2004

Attorney General Richard Blumenthal
State of Connecticut
Attention:  Tom Ryan: (Mental Health Vendor Investigation: Wards of State)
(Fax) 860-808-5391

Dear Mr. Ryan:

Thank you for following up with Ablechild.org request for a meeting with the Attorney General for inclusion in the on-going State investigation into the mental health services provided to children mandated into State care.  Our organization is delighted to hear the State has launched such an investigation into the behavioral health vendors that supply mental health services to children in State care.  We are eager to have input on current procedures, and safeguards afforded to children within the Department of Family Services.

However, as discussed in our telephone conversation of March 12, 2004, several things have alarmed our organization about the investigation that is underway.  With review of the Attorney General’s Press Release and his recent article in the New York Times, our organization feels that the Attorney General has already reached a conclusion prior to the start of the investigation.  His press release reflected a conclusion that more mental health services are needed and insurance companies need to pay for these mental health services.  This concerns our national parent organization since the question is not the quantity of mental health services but the quality and nature of such services, particularly when children are misdiagnosed or over-diagnosed with a mental illness they do not have and are prescribed controversial drugs that they do not need.

There are several issues that we wish to raise regarding psychiatric drugs that are being prescribed to children in state custody.  The first issue is accountability and informed consent.  Children mandated into state care are being prescribed drugs without proper informed consent, with no accountability.  The State, itself, has yet to determine the ethical implications of using behavioral drugs on children mandated into State care[1].  There are no safeguards in place to prevent the trafficking of children into behavioral drug use and or clinical drug trials.  The State bears the responsibility and liability of this.  The second issue we wish to raise is the drug risks, and the fact that children in state care are being placed on certain drugs that are not approved for use in children.  Many of these drugs being prescribed were last year banned in the U.K. for use in children due to their propensity to cause children to commit suicide or violent acts.  On February 2nd of this year in response to the U.K.’s ban of the drugs the FDA launched its own investigation into the same drugs regarding the same safety concerns.  Our concern is that the children in state care are placed into an additional risk category, as they do not have the luxury of having a parent or caregiver to fight for their rights to informed consent and basic health and safety.  Children that are placed into state care are many times being mandated by the courts to take dangerous drugs against their will (The New England Law Review AN ANALYSIS OF THE LEGAL ISSUES SURROUNDING THE FORCED USE OF RITALIN).  Mandating mental health services does not provide the child with their basic right to refuse “treatment”.  This raises serious constitutional issues.

A third concern our organization raises is that many of the diagnoses placed in a child’s files are derived from subjective and inaccurate testing measures.  We need to clearly point out several key points to you and will use just one diagnosis as an example-ADHD/ADD.

  • Our organization has found from documenting parents stories, that ADHD/ADD is usually the first subjective diagnosis slapped onto a child because it encompasses a vast list of behaviors that many children would fall under.
  • In 1998 the National Institute of Health issued a Consensus Statement on ADHD stating, “…We do not have an independent, valid test for ADHD, and there are no data to indicate that ADHD is due to a brain malfunction.”
  • The Department of Defense commissioned report invalidating the tests that are being used to diagnose children.  See https://www.ablechild.org/right to refuse/continuous_performance_tests.htm
  • The state of Connecticut does not have a policy on ADHD nor does it endorse a test for ADHD/ADD
  • The Federal government itself does not have a policy or endorse a test for ADHD
  • Under State Statutes there must be regulations in place governing the requirements of doctors to validate a diagnosis before he/she can prescribe a controlled substance.  Without a state or federal policy in place or a valid test to substantiate a diagnosis, a red flag is raised whether doctors are in violation of the uniformed controlled substance act.
  • Forcing/mandating drugs on children without informed consent when there is no policy governing such said actions.
  • Our organization has requested that the state of Connecticut dismantle its ADHD Task Force within the Department of Special Education https://www.ablechild.org/Letters/letter%20to%20comissioner%20sergi%20ct%202-23-04.htm.

 

As per our conversation, the State has placed our organization into an awkward position by requesting that we provide the State with confidential case histories of children that do not have legal representation to pursue their complaints against the State.  These parents have already tried to reach every responsible person in the State of Connecticut for help and have come to AbleChild.org to request advocacy.  At this point, we can verify that the parents have legitimate concerns based on their DCF case files. We are in contact with these parents; and we are updating them on the State’s investigation. Ablechild.org does not want to jeopardize their ability to pursue legal action; and we do not represent their legal interests.   Therefore, we have encouraged them to seek legal guidance and feel it is inappropriate to supply the State with requested documents.  These parents have expressed great interest in the State’s investigation and have indicated a willingness to participate.  We will supply them with a copy of the response to this correspondence.

We feel strongly that it is of utmost importance we keep all of our parents across the country informed as to each step our organization takes in bringing forth their concerns.  We want to ensure that all aspects of the issue surrounding forced drugging of children by schools and states alike are an open and transparent process.

As discussed, AbleChild.org has been in touch with over 750 parents across the country coerced into drugging their children for behavioral/attentional issues. Our organization has been actively participating in the FDA Hearings and is currently pursuing a new federal bill “The Child Medication Safety Act” –S.1390.  Your office indicated interest in the current federal SSRIs and ADHD litigation.  See below reference attorney’s name and firm link.

We look forward to meeting with the Attorney General to help the State with its on-going investigation to ensure our parent’s voices are included.  The State of Connecticut bears a great burden and responsibility during this investigation, which has national implications.  We feel there is no better place then the Constitution State of Connecticut to scrutinize policies that affect the health and safety of children.  We look forward to your response.

Respectfully,

Sheila Matthews,
National Vice President

www.ablechild.org

fax (203) 966-2840

ph (203) 966-8419

 

cc: James Comey, Deputy Attorney General United States
Governor Rowland, State of Connecticut
Senator Sullivan, President of the Connecticut Senate
Citizen’s Commission on Human Rights:  Connecticut Chapter

Referenced: Federal Litigation: Alan Milstein, www.sskrplaw.com

Bishop Lori, President’s Commission on Mental Retardation

Three Connecticut Coercion Complainants –During Ward of CT State Status

The Hartford Courant

[1] Document reference Hearings on the federal level: The Right to Privacy Inquiry as it relates to the Use of Behavioral Modification Drugs on Children.

Senator Dodd Steps into FDA Investigation and leaves The “Child Medication Safety Bill” Behind

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

 Today, Senator Dodd finally takes a position on the SSRI Antidepressant Crisis in America, but it is not in the support of children as we would have hoped, but rather in the corner of the Special Interest lobbyist group the “Psychiatric Industry”.

“Senator Dodd has been made aware of the 17 families from his State that have come forward to tell of coercion to place their young children on SSRI, antidepressants and behavioral drugs within the public schools”, says Sheila Matthews, National Vice President of www.ablechild.org. “He also is well aware of the two board members of www.ablechild.org who have lost their children from the marketed psychiatric labels and dangerous drug treatment being foisted upon parents. Senator Dodd has failed to act on a bill that would protect parent and children’s rights. Instead, he writes to the FDA during an ongoing investigation to lobby for more drug research on children even with knowledge that these dangerous drugs have been directly linked to suicide in children. “Just what parents don’t want, dangerous drugs tested on our children.” Ms. Matthews added.

Senator Dodd’s office seemed unaware of the already $25 million dollars spent each year on drug research for “adhd” and other behavioral labels through the NIMH. His response seems to be the same; he is against coercion, but is not willing to sign an anti-coercion bill to protect children. He calls for more hearings, when the hearings have already taken place.

The fact is “children are dying” and parents want action on the Child Medication Safety Bill, not more drug research at the expense of our children. Parents are becoming more and more educated on the fraud of attention deficit disorder and the dangerous drugs tied to the label. Senator Dodd is clearly out of touch with parents from his home State of Connecticut as well as those from the rest of the Country.

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.

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

Written by Sheila Matthews on . Posted in Articles.

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

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

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

Written by Sheila Matthews on . Posted in Articles.

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 www.ablechild.org proudly supports the parents that go before the FDA and take a stand for children. For more information, please visit www.ablechild.org