ablechild letters

September 20, 2004

SUBJECT: Off-Label Antidepressant Use In Children

Dear Chairman Walden and Members of the Committee on Oversight and Investigation:

Careful reflection and deep concern generates the action of the undersigned to seek your support of our main mission and that is:

THE ABOLITION OF OFF-LABEL PRESCRIBING OF ANTIDEPRESSANTS, SSRIs, AND PSYCHOTROPIC DRUGS FOR CHILDREN.

It must be noted-Any drug not proven to be safe, effective, or beneficial for children must be viewed as dangerous and life threatening to children and must immediately be withdrawn from availability for prescribing to children. These drugs must not be permitted to return as drugs available for child prescriptions until they have been proven effective, safe, beneficial, and no longer bear a threat to children lives. The loophole of off-label prescribing must be eliminated, thereby protecting the lives of children across America.

During the course of your televised hearing over CSPAN2 on September 9, 2004, Dr. Janet Woodcock, FDA Deputy Commissioner of Operations, stated, “The jury is still out on the effectiveness of these drugs,” referring to the antidepressant drugs in question before your committee. Dr. Woodcock went on to say these drugs “…Haven’t met FDA standards for effectiveness”, so they are NOT APPROVED FOR KIDS! THEY ARE NOT APPROVED – and yet they are prescribed rampantly across the nation to innocent children through trusting parents via OFF-LABEL PRESCRIPTIONS without regard to the dangers that are inherent to these drugs. Our organization has received hundreds of complaints from parents who attest to the fact that doctors are prescribing these UNAPPROVED drugs to their children and NOT properly informing them of the fact that they are actually not approved for use in children. Furthermore, they are not being told the risks that could accompany the use of these drugs. This is clearly a violation of informed consent.

Mr. Chairman, when you queried Dr. Woodcock on her above statement as to the fact the drugs have not been found effective, beneficial nor safe for children, Woodcock clarified the position of the FDA by stating they did not want to withhold “help” to these children because “Pediatric depression is a life threatening illness.”

We, as well as you, are aware that there are no X-Rays, biopsies, blood tests, or brain scans that verify Depression as a disease or illness. Our organization works firsthand with doctors who will verify this statement as fact, as well. This fact alone should dispel Woodcock’s misleading and unproven statement, as it has no merit up against the conclusive studies demonstrating real risks from these drugs to our children and young adults. Depression as a “disease” is fiction, whereas suicide ideations and violent reactions as common risks of these drugs are based in fact.

Far too many parents, grandparents, relatives or friends of children or young adults have in fact attempted or committed suicide as a direct result of these very drugs and have become victims! Their families are victims as well, for they entrusted their youngster or loved one to the medical and mental health “professionals”, and to the overseeing U.S. Government body known as the Food and Drug Administration (FDA), who they sadly believed had their children’s safety as a priority.

As an agency empowered to safeguard the health and lives of America’s citizens, the FDA has elected (as evidenced by their behavior ongoing before your committee),

withholding of information and/or evidence for your investigation, which was noted by the memo Congressman Barton uncovered, instructing them to do so. Rather than upholding the agency’s edict to safeguard America’s citizens, they have elected to ally themselves with Big Pharma, forsaking their duty to represent the health and safety of our people and failing to protect the lives of our citizens. Consequently, they have elected to endanger the lives of our children by withholding both clinical trial data and information relevant to the health, lives and families they are empowered to protect.

We applaud the efforts of your committee and what appears to be the commitment of it to uncover the truth as it pertains to these antidepressant drugs under scrutiny. It is imperative that termination of off-label prescribing should be raised to priority level to ensure that the American public, and most especially her children do not continue to fall victim to misinformation, and what amounts to pharmaceutical experimentation.

We sincerely request that you take action on behalf of our vulnerable children, placed in considerable danger by those with vested financial interests without regard to our children’s safety. At the very least, you should attempt to rectify this gross miscarriage of justice and act in memory of those who have died as a result of these drugs!

We stand ready to assist you in any possible way we may, as individuals, and as an organization dedicated to ensuring that all America’s citizens health, safety, and most especially her children’s well-being is prioritized and upheld!

Sincerely,

Gloria Wright Sheila Matthews

Ablechild.org Ablechild.org

Vice President-North Carolina National Vice President-Connecticut

Patricia Weathers

Ablechild.org

President and Founder –New York

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