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

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

 The issue of psychiatric drugs and children is once again being challenged. The Nation has its eyes on Florida , where there are two bills that define the legal debate behind behavioral modification drugs used on children. This debate involves full informed consent and the right to refuse psychiatric “treatment.” Senate Bill 1090 “Relating to Minors/Psychotropic Medication” is aimed at allowing the State of Florida to give a Judge the ability to determine which child receives psychotropic “medication” and which child does not. In contrast, Senate Bill 1766 “Relating to School Students/Psychotropic Medication” would ensure informed consent and the constitutional right to refuse psychiatric “treatment.” Overall this bill would protect the rights of the child and the family.

Senate Bill 1090’s overall goal is to rip the informed consent away from the parent and family and exploit the most vulnerable population of children, those in State Care. This bill also allows for a judge to over-rule the parent’s consent if that parent declines psychiatric “treatment” for their child.

Senate Bill 1766 supports a parent’s right to full disclosure that must include the fact that there is no medical test for a psychiatric disorder, and that the child’s behaviors could be the result of underlying physical conditions. This would safeguard the vital interests of children and would provide critical information to parents and caregivers, and their ability to make an informed decision regarding the health and safety of their children.

Florida has entered the battle zone. The rest of the nation will watch as basic human rights are on the line. Now we wait for the people to speak.

Which bill will prevail?

For more information on how you can help protect children and their constitutional rights visit us at www.ablechild.org.

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

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

 Ablechild has submitted a written request to the United States Attorney for the District of Minnesota, as well as the FDA, requesting a full investigation into the latest School Shooting linked to Antidepressant use that took place on the Red Lake Reservation in RED LAKE , Minnesota on March 23, 2005. Jeff Weise was taking Prozac when he unleashed his wrath, first at his grandfather, and then at fellow students and teachers in his school ending with him turning the gun on himself. This latest rampage eerily mirrors the many other adolescent school shootings, which have raged havoc on this great nation, and of which the “common denominator” has been psychiatric drugs linked to violence.

This fact demonstrates that this is not mere coincidence, but an emerging pattern that compromises public safety. The public is becoming educated to this emerging pattern, and with that comes outrage and frustration directed in part at the FDA for failing the public, by continuing to turn a blind eye to the all so obvious link to violence and mania that these drugs are having on our youth, and even more, their deadly link to uncontrolled school terror that has occurred from coast to coast.

Ablechild has previously requested that the FDA provide accountability, where there is none. Accountability is critical now, more than ever, to ensure public safety as a whole.

Ablechild points to the fact that “After 16 years of denial, a series of Eli Lilly (the maker of the drug Prozac) documents that have recently surfaced publicly shows the company’s own review of Prozac in 1988. This review, by Lilly themselves, reveals that even in controlled clinical trials–from which suicidal patients are excluded — 38% of patients taking Prozac compared to 19% of patients on placebo experienced “activation.” Their term “activation” is used to describe violent and or suicidal behavior. The authenticity of the Lilly-Prozac documents has not been disputed.”

See: http://www.ahrp.org/infomail/05/01/27.php.

The link to violence associated with antidepressants is the writing on the wall for all now to see, a link that for well over a decade has been present, but has been willfully and deliberately ignored by those with vested interests in, and ties to, the multi billion dollar pharmaceutical profiteering occurring within this nation. This profiteering, time and time again, continues to override the health and safety of the public.

This “writing on the wall” is further confirmed by the FDA’s own thorough independent examination of all the clinical trial data of the SSRI antidepressants reported to the FDA, in April 2004, which led to the FDA requiring that all antidepressant drugs, including Prozac, carry explicit warnings, referred to as “blackbox,” that apply to anyone taking these antidepressants. These warnings point to the obvious, which is, that not all these drugs are as “safe” or as “mild,” as drug companies, and those with financial ties to drug companies, would have the public believe them to be.

According to the FDA’s own admission, these drugs are associated with very real risks.

“The emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility (aggressiveness), impulsivity, akathisia (psychomotor restlessness), hypomania, and mania have been reported in adult and pediatric patients being treated with antidepressants…” See: http://www.fda.gov/cder/drug/antidepressants/default.htm

Dr. Steven Galson, from the FDA has received our organization’s request for the FDA to launch a full investigation into this urgent matter, immediately. Ablechild strongly urges all to fax Dr. Galson with a request for a formal public statement into this matter. In addition, we urge every individual to request that the FDA conduct a full investigation into the school shootings occurring nationwide, and their link to antidepressant induced violence, mania, and terror. This terror must end, accountability is long overdue.

Dr. Steven Galson
Fax: 301-594-6197
FDA phone number is 301-594-5400

For more information on antidepressants and associated “blackbox” warnings, mental health concerns regarding children and psychiatric drugs go to www.ablechild.org.

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

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

  Hartford, Connecticut Legislative Education Committee failed to act on a parental informed consent bill that would ensure that parents receive full informed consent prior to any psychiatric testing being done on their children in public schools. This bill HB #5328 was written to safeguard parental rights and would have ensured that each parent be provided with certain regulations and amendments, informing them of their basic right to “opt out” of psychiatric testing for their children through state public schools. Connecticut was a frontrunner in protecting parental rights, by being the first state to pass a law to prohibit schools from recommending psychotropic drugs to parents for their children. This first state law prompted several other states to take similar action in response to a parental outcry, in which reports by parents of schools coercing them to place their children on psychotropic drugs (e.g. Ritalin) to remain in school became all too common. The states’ response and chain reaction, in turn, led to similar Federal legislation, “The Prohibition on Mandatory Medication Amendment,” signed into law by the President December 3, 2004.

This informed consent bill comes on the heels of many disturbing occurrences, which have brought the issue of labeling and “medicating” children national attention. Just last year the FDA launched two sets of hearings into the safety and efficacy of antidepressants in children. In response to these hearings a massive Federal Congressional hearing was convened on this same matter, as well as, to review the FDA’s lack of accountability and financial conflicts of interest. More recent events show Health Canada suspending its marketing of Adderall XR, a psychotropic drug and stimulant used in the “treatment” of ADHD, due to related deaths.

In the wake of so much turmoil and grave concerns, an informed consent bill, looks like a safety net where there is none. The bottom line is that parents cannot make educated decisions without being provided with all the facts. Today, schools continue to profile children for mental disorders like ADHD by using subjective checklists, rating scales, or assessments, not even endorsed or approved by local, state or federal government. Parents are not being told this. These same subjective psychiatric assessments for ADHD were removed from the state of Neuvo Leon in Mexico last year by the Secretary of Education herself, due to their subjective and unscientific nature.

The culmination of events questioning the safety and efficacy of behavior modifying drugs on children, and the subjective assessments used in psychiatric diagnoses, should not be discounted. Everyone needs to be asking why the state’s education committee blatantly has turned a blind eye to parental rights, and has disregarded widespread concerns without providing for a hearing on this matter.

More pointedly, we should be asking why America , or her states, is not ensuring parental rights and protecting children’s health and safety.

For more information on ADHD, informed consent, and mental health within education please visit our site at www.ablechild.org.

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.

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.