“Full Access” to Mental Health Failed Pittman Boy

February 4th, 2005 | Press Releases

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

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

 Excerpt: “Didn’t Your Brain have to tell you to Do it?” State’s Attorney questioned the gun expert In the State of South Carolina vs. Pittman

The Christopher Pittman tragedy is being played out in America this week in a small South Carolina courtroom where he is standing trial for the shooting deaths of his grandparents over three years ago. Now, a fifteen year old slender, inconspicuous boy, Christopher is being tried as an adult for the crime which he committed at age twelve, a crime that the defense can legitimately argue was induced by the drug, Zoloft, long suspected of causing possible mania and psychotic episodes and recently linked to suicide ideation.

Pfizer, the maker of the drug Zoloft appeared in court earlier in the week asking that the judge exclude from the defense, certain documents pertaining to their drug, arguing that these documents were “subject to protective orders” in another civil case. This is reminiscent of the October 2004 Congressional Hearings where Pfizer, along with other pharmaceutical giants, was mandated by the Committee to disclose all negative clinical data regarding its SSRI class antidepressant, data which had previously been withheld from the FDA and from the General Public.

At the same time, as the state attempts to prosecute this boy and eradicate any responsibility that this drug had on his mind at the time of the crime, it must dispute the growing evidence linking the drug with violence and mania. It must then prove safety and efficacy for the use in children. The state’s job looks insurmountable considering the FDA itself did not approve Zoloft for use in children.

The State’s gun expert showed the jury how to load and shoot the gun that was used to commit the crime. This demonstration led to a revealing question posed by the State’s own attorney, Barney Giese, “Doesn’t your brain have to tell you to do it?” For better or worse, the state finds itself in a dilemma, relying on psychiatrists own admissions that the drug Zoloft changes brain chemistry and alters human behavior.

Christopher Pittman did not arrive at this courtroom solely by his own actions, others bear responsibility. This boy had “full access” to mental health “treatment” with no barriers. This “full access” altered the course of his life. As Christopher Pittman faces life in prison, one must wonder: If he did not receive this questionable mental health “treatment”, would the outcome be the same? More precisely, as disturbing as it is, it is not where Christopher Pittman goes from here, but where he has been.

For further information regarding antidepressant risks in use in children and legal cases pending visit www.ablechild.org

Lt. Governor Sullivan Throws Connecticut Taxpayers’ Money to the Wind, Proposing $34 Million Dollars on State Mental Health.

December 28th, 2004 | Press Releases

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

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

 Some Connecticut residents call Sullivan’s new proposal just plain wasteful spending, exorbitant plans for throwing Connecticut’s money away without addressing the immediate need for an overhaul in what they deem is a Broken Mental Health system.

Hartford , Connecticut . Lt. Gov. Kevin Sullivan’s recent press release “Sullivan Unveils Mental Health Reform Package” has raised more than a few eyebrows across the state from children right advocates, as well as from victims of mental health abuse. Sullivan proposes to spend a whopping $34 Million on mental health in a one-year period alone. This money would be spent on additional services and programs without addressing the need for reforms in many areas of the current mental health system. This added funding for areas that have not proved themselves successful should be viewed critically and be cause for great public concern.

To give observers an inside view of the current system and its expenditures, they need only look at the many departments offering mental health services to the public.

Currently the State’s Department of Social Services has operating expenses of just under $200 million. This department carries program expenses, many of which are mental health based, of over $3.5 billion per year. The Connecticut Department of Children and Family Services both have operating expenses at over ½ a billion dollars per year. This spending is taking place without any accountability. Lack of accountability is two-fold, comprising of the State’s own failure to hold the department heads, as well as the many vendors of mental health services and programs accountable for justifying the need for the mental health programs/services that they are using and or soliciting. Furthermore the State is failing to hold all those providing mental health programs/services to the highest standards, by not requiring them to provide comprehensive reports demonstrating their success rates.

To spend additional money on any mental health services without seeing a track record for programs and or services already offered within the State should alarm all Connecticut taxpayers.

Ablechild, a national grassroots parent organization, with members in Connecticut advocating for both children and parental rights, had the opportunity to attend and testify at one of Lt. Governor Sullivan’s town hall meetings.

Ablechild was eager to share its concerns regarding the protection of human rights and the critical need for expanding mental health services beyond that of psychiatry, asking for the State to consider advocates and vendors employing non-drug and non-invasive programs/services for parents and children throughout the state. Alarmingly this town hall meeting consisted mostly of current mental health vendors asking for more money. What was obvious was that there was little evidence of success in their current programs with a basic lack of both new ideas and different types of strategies that might turn an obvious failed approach around.

“Lack of accountability is a big part of mental health and is a huge problem right now. The public should be aware and informed of all mental health programs being offered by the State. This would entail a disclosure of whether or not a program or service is successful or not. The fact that we are allowing what is equivalent to frivolous spending on programs that have not been proven successful should not be allowed to continue,” said Ms. Sheila Matthews, National Vice President of Ablechild and a Connecticut resident concerned with informed consent and the right to privacy. Ms. Matthews has advocated in Connecticut on behalf of victims of mental health abuse, many of whom have come to Ablechild for help in regards to mental health services forced upon them by State agencies and vendors receiving state mental health funds.

The question that should be raised from all of this is: When do we say enough is enough? Are we going to allow this ridiculous amount of spending without accountability to continue? Or are we going to put our foot down and hold those responsible, for truly providing us with higher standards? Accountability and honesty is what all citizens and residents of Connecticut should be demanding from the State. Anything less is simply not enough.

To read more on mental health and current abuse within mental health, please go to www.ablechild.org.

Blue Cross Issues Warnings to Doctors Prescribing Drugs with Suicide Links. Will Insurance Companies Continue to Deny Death Protections for Suicide Victims?

November 16th, 2004 | Press Releases

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

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

 News that Blue Cross Insurance are warning physicians to exercise care and caution when prescribing antidepressants comes as no surprise in lieu of the recent antidepressant crisis that has plagued America for so long now and has recently come to a swift and direct result. Scrambling for damage control is a normal response under the circumstances by insurance companies nationwide. Blue Cross simply follows suit. Their actions should be viewed cautiously and with enough skepticism from those many Americans left victimized and harmed by antidepressant use. Many want to believe that insurance companies are operating in the best interest and safety of the patient. Others more attune to reality remain skeptical. What truly motivates insurance companies to take this initiative in warning doctors to be careful?

The bottom line is that the FDA has issued Black Box Warnings on all highly marketable Antidepressants after conducting a long investigation. Even with insurmountable evidence to establish their link to suicide this investigation dragged on. In a twisted and at times almost unbelievable fashion, Congress themselves had to step in to demand that the FDA disclose its data regarding certain drugs. Frustrating, and at times even ludicrous, this investigation revealed not only a clear definitive link to suicide by these drugs, but the FDA’s and drug industries desperate attempts to hide, cover-up, conceal, distort (call it what you may) clinical trial data.

In light of all these facts, it is little wonder that insurance companies are gearing up to minimize loss. Their logic in warning doctors to err on the side of caution when prescribing antidepressants is used in an attempt to save them billions in potential lawsuits.

Take for example, in the past, if a member of your family committed suicide and was taking an antidepressant or withdrawing from an antidepressant, your legal recourse, and protections under insurance is difficult at best and more often than not, nonexistent. Now up the stakes, by throwing the fact that these drugs have black box warnings on them, clearly spelling out their potential for harm. Insurance companies are between a rock and a hard place, under the gun to justify not paying claims to potential victims of the antidepressant suicide fallout.

An industry that has previously been in the driver’s seat, one that ultimately has had the final say in denying suicide victims claims, no longer has an unobstructed path to tread down. It treads today on shaky ground; no longer sure that denying death claims due to suicide, when antidepressants are involved, is in its best interest.

Accountability measures need to be enacted that would ensure that the families of victims of this antidepressant suicide crisis receive immediate protection and justice in the form of financial compensation.

Several flaws in a questionable system stress the importance of accountability here where it has been previously lacking. They are as follows:

  • Proper and full informed consent needs to be provided to the patient in writing prior to any psychiatric “treatment”. This entails revealing to the potential patient the risk of suicide when prescribing an antidepressant.
  • Toxicity testing on suicide victims is not mandated and needs to be required. Victim’s families are not provided with the information on the importance of toxicity screening and are not given the actual procedure on how to request testing at the time of death.
  • Suicides have been and are still routinely blamed on a person’s mental state or a person’s psychiatric diagnosis, rather than on the psychiatric “treatment” that the person had received prior to his death. This occurs routinely without scientific backing or verification of it being a fact. In this way, drug harm, is often overlooked or disregarded.
  • Overall, s uicides are rarely investigated on a national level. This prevents critical information from being gathered and used to factor into determining possible links or causes of suicide. Statistics need to be obtained.
  • Under “Right to Treatment”, insurance companies have been required to cover dangerous and risky psychiatric “treatment” even when the diagnosis itself does not withstand evidence-based criteria. Simply put, a person is diagnosed with a psychiatric disorder based on lists of subjective behaviors rather than on confirming, objective blood tests or brain scans.

The overall picture is one that shows the drug industry, and the psychiatric Industry conveniently not being held accountable. Both groups arm themselves with strong lobbying groups in Washington whose sole purpose is to grease the palms of our political representatives.

In the midst of all this confusion, insurance companies are left with half-hearted attempts at restoring order in a disordered and chaotic system.

For more information on the risks of suicide and antidepressants and the recent “Black Box Warnings” on antidepressants, please visit us at www.ablechild.org.

One World, One Child Benefit Event

November 11th, 2004 | Events and Photos

ep_04_11_11_chec_banner

AbleChild was cordially invited and had the pleasure of attending One World, One Child Benefit on November 11, 2004 at the Plaza Hotel in New York City . This event brought us together with both Children’s Health Environmental Coalition (CHEC) and Arts for Healing, both superb organizations dedicated to creating a healthier world for children.

Sheila Matthews and Patricia Weathers at One World, One Child Benefit. Patricia Weathers with Karen Nisenson Co-Founder and Director of Arts for Healing.

Ablechild Joins NAACP’s Call for Psychiatrist’s Resignation. Civil Rights Groups will not ignore “Gene Pool” comment.

November 5th, 2004 | Press Releases

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

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

 Recently, in a Texas Committee hearing on Psychotropic Drugs and Foster Care Children, a psychiatrist, Joe Burkett, testified regarding foster care children. In what proved to be one shocking and horrific moment for child advocates everywhere, he informed the committee that one of the main reasons so many foster kids need to be on psychotropic drugs is that “they are very sick, from a Bad Gene pool”.

Last week in Austin, civil rights groups and critics of the state’s welfare agency, of which included the NAACP, demanded the resignation of this psychiatrist.

Ablechild is in full support of the NAACP’s request. We wholeheartedly assert that we will continue to back groups committed to safeguarding children’s rights. We reassert the call for an immediate and swift kick out of office for this psychiatrist, who clearly, by his flippant and de-humanistic statements, is not representing children’s health and safety.

In response to Civil Rights groups call for his resignation, Joe Burkett, in the Dallas Morning News, October 27, 2004, said that he did nothing wrong and has no plans to quit. Questioned regarding his “Gene Pool” statement Burkett responded to the Dallas Morning News stating, “There are pretty strong genetic factors in mental illness. The comment…was really a comment about the fact that these children are in the foster care system because they don’t have normal parents making good decisions….” “That’s really the connection I’m making with genetics.”

Based upon Burkett’s recent statements, Ablechild as well as other civil rights advocates call upon Burkett to produce certifiable evidence of these “genetic factors” in foster care children.

Burkett is well aware, as are we, that there are No objective tests to verify with certainty a genetic component for mental illness. Unless Burkett can miraculously pull out of his hat scientific proof in the form of a blood test, x-ray, biopsy, or exact brain scan verifying such a statement, he should be held accountable for deceiving the public, and attempting to divert public attention away from his original and most damaging statement.

Just one example of the division within the psychiatric and medical community regarding how “scientific” psychiatric diagnoses truly are can be pulled from Clinical Psychiatry News, January 2000. Dr. Theodore Pearlman, a psychiatrist in Houston, speaking about the DSM-IV, the billing bible for psychiatry and what psychiatric diagnoses are based upon, stated that DSM-IV has gone too far. “There are too many diagnoses without any objective basis or biological support,” Dr. Pearlman went on to say.

This is one doctor out of many who have challenged the “genetic factor” and or elusive “chemical imbalance”, clearly recognizing their theoretical foundations demonstrating lack of proof.

Burkett’s comments highlight the failed approach psychiatry as a whole has marketed to the public encompassing both our foster care system and education system. Psychiatrists, like Burkett, should be held accountable for putting forth misleading and biased information to the public to skew perception or understanding of this topic.

“Marketing theories of “bad genes,” “chemical imbalances,” or “diseases” for diagnoses such as ADHD for one, has led to a tremendous increase in the number of children labeled mentally ill and trafficked into drug use without proper and full informed consent”, said Sheila Matthews, Vice President of Ablechild.org a grassroots parent organization dedicated to safeguarding children’s rights and ensuring that all receive full informed consent prior to any psychiatric “treatment”.

Children falsely accused of suffering from subjective mental disorders is a disturbing issue that has been taking place without question for far too many years. It is painfully obvious to so many now that the Psychiatric Industry is allowed to oversee the foster care system without any independent oversight or accountability. It has been a long time without justice for these children. They deserve more.

We need to recognize that it is the time to act and attempt to get both educational and healthy non-drug approaches over the walls to these unprotected children, instead of promoting and allowing the psychiatric gatekeepers and their tentative theories to remain at the helm.

For more information on mental health and its role in foster care abuse and for recent information on the FDA’s issuance of Black Box Warnings on Antidepressants given to children nationwide please visit our site at www.ablechild.org

Children Suicide “Cluster” in Pennsylvania. Is Antidepressant Use to Blame?

October 28th, 2004 | Press Releases

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

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

 As Pocono Mountain East High School reels from its third unexplained child suicide that has occurred within the past six weeks, the mental health industry scrambles to explain away what so many people in this country, and in the U.K., have slowly but clearly begun to understand. Three child suicides all involving children who attended the same school inside of six weeks would appear alarming to the average person, but not to the American Psychiatric Association, which issued this statement concerning the matter. “Reports of suicide “clusters”, in which one suicide appears to trigger several others within a group such as a school or community, have increased.”

To say that suicide clusters have increased without addressing a possible antidepressant link is a “smoke screen” attempt to take our attention away from the stark reality, the shock, and horror that the average person would have to know that 3 children all attending the same school killed themselves all inside a 6 week period. One would think right away, what are the odds?

Psychologist Sara Camaerei, who practices with Family Treatment Associates of Stroudsburg, PA had this to say regarding the recent cluster of child suicides. “Suicide is a taboo in our society. No one likes to talk about it. When one individual commits suicide, it removes the taboo and others could think that maybe it’s an alternative.”

A taboo, simply put, is anything prohibited or forbidden by society, tradition or convention. To blame suicide on the fact that it is a taboo within society and that children are more likely to kill themselves because society as a whole does not like to talk about suicide is a far-reaching theory. To reach further and state that one child suicide would encourage other children to follow suit, simply killing themselves because this “taboo” has been removed, is another questionable theory that offers very little answers and does not get to the crux of the situation.

The reality is that both statements produce a tremendous amount of much needed “smoke and mirrors” on the mental health industries part in their futile attempt to divert our focus away from more logical explanations. The reality is that both statements and point of view do not address the current antidepressant crisis happening in this country and the very real plausible explanation into why children are killing themselves at such a rapid rate.

The facts should speak for themselves and override any meager attempts by a profit driven industry to explain away child suicides. The facts should not be covered up or go unheard when children continue to die. They are:

  • Last years ban of antidepressants for children in the U.K. due to their link to suicide ideations.
  • This years FDA investigation into the antidepressant link to suicide and violence.
  • This years Congressional Investigations into the FDA’s failure to act in the best interest of public safety by attempting to withhold crucial drug research and studies from the public.
  • The drug companies ability to withhold clinical data from the FDA and the public that clearly linked antidepressant use with suicide.
  • The recent issuance of “Black Box Warnings” by the FDA on all antidepressants clearly spelling out their link to suicide.
  • Over 850 parents have come forward on a national level to report being pressured and coerced by nation schools to place their children on behavioral drugs and antidepressants.
  • Parents and advocates taking action within states across the nation to enact state laws outlawing the prevalent practice of coercion by schools which led to the Federal government proposing “The Child Medication Safety Act,” which would safeguard both parental and children’s rights http://ablechild.org/flegislation.htm.
  • Lack of a tracking system in place for each State and for the Nation overall, that would comprise useful data regarding the number of children dying as a result of psychiatric drugs.

These facts cannot be discounted. The question remains: Is the American public going to continue to buy into the mental health industries “smokes and mirror” attempts to dispel, distort and overshadow children dying, and the reason why they are dying?

Is this incident at Pocono Mountain East High School in Pennsylvania so easily swept under the rug by the industry promoting unapproved drugs to children? Will the American public allow this to happen?

The American public needs to demand accountability. Three child “cluster” deaths in Pennsylvania should be enough to prompt a full Federal investigation into the matter. The public needs to have access into the number of children dying as a result of psychiatric drugs. No accountability and No oversight is just plain Unacceptable.

For more information on children’s mental health issues, Federal and State laws involving a child’s right to grow up drug free, and education please visit www.ablechild.org.

Psychiatrist Blames Bad Gene Pool for Massive Drugging of Foster Care Children in Texas

October 11th, 2004 | Press Releases

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

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

Does this indicate the Resurgence of Eugenics in America?

On October 4, 2004 in a Texas Committee hearing on Psychotropic Drugs and Foster Care Children, human and children rights advocates were stunned when psychiatrist, Joe Burkett, informed the committee that one of the main reasons so many foster kids need to be on psychotropic drugs is “they are very sick, from a Bad Gene pool”. Another psychiatrist, Dr.Sargent, re-emphasized how very sick these kids are, and how these children’s brains are wired differently, requiring them to receive “expert” psychiatric care.

“This Bad Gene Pool” and “sickness” belief system is very alarming to many child right advocates who look to find effective, healthy, non-drug solutions for children in state care; children who more than likely have experienced trauma and stress within their environment and have had natural reactions to such. John Breeding, founder of Texans for Safe Education and author of “The Wildest Colts Make the Best Horses”, and “True Nature and Great Misunderstandings” testified before the committee. Dr. Breeding challenged the Bad Gene Pool theory. “That is just not true. Once we label these children, we stop thinking of strategies to help them succeed and master the coping skills needed in society.” Dr. Breeding called for a seven-step approach to reform, which would include strengthening informed consent laws, thereby increasing the likelihood that accurate information regarding the subjective nature of the diagnoses, being all too eagerly assigned to children placed in state care, is given to childcare providers. This would also ensure that state childcare providers given all the information, would be less likely to discount the overwhelming risks associated with drug “treatment”.

Texas is not the first state that has initiated hearings, investigations, and litigation regarding widespread abuse, which includes the rampant drugging of children within state foster care.

  • Massachusetts just this year launched an investigation into tracking how many of its children in state care are on psychiatric drugs. · Washington, California, Illinois, and Florida are just some of the other states that have tackled the overall systemic abuse as well.
  • Last year, Connecticut was the first state to actually ban the use of two unapproved antidepressants on children in state care.

What is quite clear from this is that children in the foster care system nationwide are clearly unprotected on a human rights level, and with current “bad gene pool/sickness” ideology being spread publicly, there is little hope that the current nationwide crisis within state foster care programs will get any better.

Two psychiatrists spouting comments regarding “bad genes” is alarming to say the least, but what is more disturbing is the unanswered question: Does this indicate that the American Psychiatric Association condones such ideology? If so, is any hope lying ahead for children remanded into state care? Or, are these children designated “human research subjects” for popular and profitable drug “treatments”? Ideology espousing concepts of “bad genes” and inferiority among humans based on characteristics bares a striking resemblance to the science of Eugenics that deals with the improvement of races and breeds, especially the human race, through the control of hereditary factors. We can recall that Hitler employed this same ideology in Nazi Germany. What many do not recall however is that it was also used in our country in the early 20th century within mental asylums when experimentations were conducted on people deemed an inferior sect of human beings.

This mindset contrasts sharply with our country’s founded principals of democracy, which espouses that all men are created equal.

Ablechild’s National Vice President, Ms. Sheila Matthews stated that, “This Bad Gene Pool” comment is very damning to the entire psychiatric industry and should send a wake up call to all America! These children are clearly vulnerable and are fair game for drug research, with no accountability whatsoever. All who care for children should be distraught at this public display of disregard for these children’s health and safety.”

For more information regarding foster care abuse, mental health and children, please visit us at www.ablechild.org

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

September 20th, 2004 | Press Releases

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

September 15th, 2004 | Press Releases

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

August 21st, 2004 | Press Releases

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.

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