“Best Pharmaceuticals for Children Act” S-838
Thursday October 18 5:59 PM ET Senate Moves to Better Drug Study By JIM ABRAMS, Associated Press Writer [Comments by Fred A. Baughman, Jr., MD 10/19/01] WASHINGTON (AP) - The Senate moved Thursday to expand a program that pushes drug companies to test and label their products intended for children's use. The "Best Pharmaceuticals for Children Act," passed by voice vote,extends a measure enacted in 1997 that gives six-month market exclusivity to drug companies that conduct studies on their products' effects on children.
[Fred A. Baughman Jr., MD:
this Act, it appears, refers primarily to psychotropic drugs, none of
which
are prescribed for diseases, but rather, for normal children with normal,
emotional/behavioral problems (none proved to be diseases). The question
I
have of the "Best Pharmaceuticals for Children Act," is, should there be
any
such pharmaceuticals at all? With no disease on the "risk" side of the
"risk"
vs. "benefit" equation, the only physical risk in such treatment
situations,
is that which is borne by the drugs themselves. All of them are
brain-altering (that is how they work) and brain-damaging, short- and
long-term.]
That bill is to expire at the end of this year. The legislation, sponsored by Sens. Christopher Dodd, D-Conn., and Mike DeWine, R-Ohio, also would set up a federal fund to investigate the effects of off-patent drugs. DeWine said an off-patent drug such as Ritalin is administered to children under six years of age even though "we simply do not know the safety, and the effectiveness, of this drug for such young children."
[Fred A. Baughman Jr., MD:
we do know,
Senators Dodd and DeWine, that the children labeled ADHD have no bona fide,
demonstrable disease; that they were normal before the drug ingestion was
begun. In fact, the risk/benefit ratio for ADHD (illusory, invented,
fraudulent) "treated" with Ritalin, Adderall, Dexedrine, any drug, is simply
not justifiable. The incessant claims of psychiatry, the AMA, AAP and the
rest of medicine, that ADHD is a disease, are fraudulent. Invite them to the
Senate, swear them, and extract the truth of the matter. It would not be a
moment to soon, we have 6 million schoolchildren taking these narcotic; 6
armies-worth of children, who because of their diagnosis and treatment will
never be eligible to join the army or any other branch of the armed services]
A privately funded foundation would be established to study other drugs commonly used by children. The legislation would be expanded to include newborns and would establish an Office of Pediatric Therapeutics at the Food and Drug Administration to coordinate activities related to children, including protection of children used in clinical trials. Dodd said that in the seven years before 1997 there were only 11 clinical trials on pediatric pharmaceuticals. In the three years since then, there have been 400 such trials.
[Fred A. Baughman Jr., MD:
And exactly as all of psychiatric and medical
academia refers, throughout their peer-reviewed literature, to such disorders
as diseases, when none of them are, their drug trials all say exactly what
paymaster, Big Pharma wants them to say--that one drug is better than the one
before it, that two drugs are better than one; three better than two. If
there were any truth in their research, no normal child labeled: diseased,
abnormal and drugged, could possibly have a better life, short- or long-term
than the just as normal , un-drugged, control subject]
"It's staggering to me that we have waited so long to do this," Dodd said. Legislation sponsors said the lack of clinical trials has subjected children to higher risks of underdosing, overdosing or dangerous side-effects. "Kids are not just miniature adults," DeWine said. "You can't just cut a pill in half." The bill must still be considered by the House. - The bill is S. 838. On the Net: Bill text: http://thomas.loc.gov/