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September
28, 2004 SUBJECT:
On-going Congressional Investigation into the FDA’s Role in
Protecting the Public Health & Examining FDA’s Review of Safety
& Efficacy Concerns in Antidepressant Use by Children PURPOSE:
Request
your committee call for an urgent investigation of the FDA by the Office
of the United States Attorney General John Ashcroft, and the matter
referred to a Federal Grand Jury. Dear
Vice Chairman Walden and Congressional Oversight and Investigation
Members: The
purpose of this letter is to reiterate our call for the immediate
cessation of the off-label prescribing of antidepressants to America’s
children. Your recent
questioning of FDA official Robert Temple on September 23 underscores the
urgency with which we believe your committee must act in order to
safeguard the health and lives of America’s children.
During
the course of your most recent meeting it was reported an FDA medical
officer was told by “top agency officials” to alter the government
record by deleting material regarding the risk of antidepressant drugs
from the records to be sent to Congress, and to conceal those deletions.
This becomes an issue of tampering with government records – a
crime. During
that hearing Mr. Temple expressed concern about scaring physicians away
from prescribing antidepressants to patients, yet expressed no concern
regarding the possible endangerment to the lives of children. Temple
also remarked that the FDA cannot police off-label prescribing of
antidepressants for children. If
the FDA cannot police the dangerous prescribing of known ineffective drugs
then we hold the Congress of the United States responsible to enact law,
or at the very least, to direct the FDA to formulate a legal action
whereby America’s children and her citizens are protected from harm by
the prescribing and use of these drugs.
To do anything less assures what we consider the continuation of
illegal and dangerous experimentation on children. We
call to your attention the testimony heard by your committee on September
9, by Dr. Janet Woodcock, whereby she stated “The jury is still out on
the effectiveness of these drugs”, referring to the antidepressant drugs
in question before your committee. Dr
Woodcock continued by remarking these
drugs had not met FDA standards for effectiveness and had not been
approved for children. Though
unapproved, and having no clinical/scientific proof these drugs are
effective in treating children they are none-the-less prescribed to
children off-label– thereby jeopardizing the health and life of any
child who ingests these drugs. The
fact that these drugs are known to have no proven effectiveness for
America’s children is withheld from parents thereby
denying them the right to full informed consent clearly crippling their
ability to make educated decisions pertaining to the issue of
“medication” and their children.
These unsuspecting parents based on a physicians recommendation and
prescription will give their child a drug that, in fact, will endanger the
life of their child; A drug, and I cannot stress this enough, that has NOT
BEEN PROVEN effective, nor safe for use on their child! So
“serious” are the concerns of Mr. Temple and the officials of the FDA
that they went so far as to prevent Dr. Andrew Mosholder from disclosing
his findings of the serious increase in risk of suicidal thoughts and
behavior amongst children caused by the drugs in question.
There also seems to be, judging from the findings of your
committee, reason to believe Dr. Mosholder was intimidated as well.
Dr. Mosholder, a medical reviewer and a government epidemiologist
with the FDA’s Center for Drug Evaluation and Research, was denied
presenting his conclusions that, in the vast majority of cases, these
antidepressants should not be given to children.
In fact, there are now two FDA analyses, including Dr.
Mosholder’s, and both reach the same conclusion – these drugs may well
double the risk of suicide for some children.
In
our previous letter to you and your committee, dated September 20, 2004,
we indicated we were calling for “The abolition of off-label prescribing
of antidepressants, SSRIs, and psychotropic drugs for children.” We
reiterate and hold accountable your investigative committee for the
immediate cessation of off-label prescribing of these drugs!
We now add to our URGENT REQUEST the following: ***
We request your committee call for an investigation of the Food & Drug
Administration (FDA) by the Office of The US Attorney General, John
Ashcroft, and this matter immediately be referred to a Federal Grand Jury
as regards to the following …
. Tampering with
government documents
. The withholding of
evidence/testimony
. Engaging in
intimidation of a witness
. The withholding of
clinical trial data from the public, directly resulting in the endangering
of the lives and health of America’s children, and indirectly causing
the deaths of many of America’s children, and the agony and grief to
their families. It appears as
though this act may be criminal in nature.
Once
again, we stand ready to assist you in any way possible, as individuals
and as an organization, dedicated to ensuring that the health and safety
of all America’s citizens, and most especially the well-being of her
children is upheld! Sincerely,
Gloria
Wright Vice President of Able Child, North Carolina
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