Below are the highlights of the Washington Post’s Jan. 29, 2004
article entitled “Antidepressant Makers Withhold Data on
Children,” written by staff writer Shankar Vedantam.
We find this article well written and well researched. Parents, if
your doctor recommends a SSRI (selective serotonin reuptake
inhibitors) for your child, or your child is currently on a SSRI,
consider looking into natural and
healthy alternatives
to antidepressants. We don’t know what these trials have to say
but you can bet it’s not good news. Otherwise, they would have
been shouting it from the rooftops.
“Antidepressant Makers Withhold Data on Children”
Makers of popular antidepressants such as Paxil, Zoloft and
Effexor have
refused to disclose the details of most clinical trials involving
depressed
children, denying doctors and parents crucial evidence as they
weigh fresh fears that such medicines may cause some children to
become suicidal.
The companies say the studies are trade secrets. Researchers
familiar with
the unpublished data said the majority of secret trials show that
children
taking the medicines did not get any better than children taking
dummy pills...
One industry executive, Philip Perera, a medical director at
GlaxoSmithKline, said genuinely effective medicines sometimes do
no better than placebos, or dummy pills, in trials -- at least
half of all children seem to get better on placebos.
Advocates say openness about studies is important because, apart
from Prozac, no antidepressant has been approved by the FDA for
treating children with depression. Doctors writing prescriptions
do not have approved labeling to guide them: They must rely on
their own judgment and the available scientific knowledge -- even
as information is being withheld.
The medicines under scrutiny belong to a class of drugs called
selective
serotonin reuptake inhibitors, or SSRIs. Led by Prozac, the first
to be approved, the medicines caused a revolution in psychiatry.
Recent analyses suggest that as many as 1 percent of children in
the United States are treated for depression in any year, said
Mark Olfson, a professor of
clinical psychiatry at Columbia University. Of those, 57 percent
are on
antidepressants...
Keeping data secret, critics said, has led to conflicting
information,
contradictory advice and heightened fears. For example,
GlaxoSmithKline, which makes Paxil, has conducted three trials on
depressed children. Company officials said all turned out negative
-- the children on the drug did not do better than those on
placebos -- but only one was published. Based on its data, the
company warned British doctors that Paxil, sold there as Seroxat,
"should not be prescribed as new therapy" to depressed children
younger than 18. Its letter last June cited the risk of increased
hostility, agitation, and suicidal thoughts and attempts.
No such warning was issued in the United States, though Paxil is
identical to Seroxat. Here, the company's official line on giving
Paxil to children is "No
recommendations can be made regarding the use of Paxil or Paxil CR
in these patients."...
British regulators have essentially prohibited the use of Paxil
for children. The FDA is conducting a review of eight drugs,
including Paxil.
Cathryn Clary, vice president for psychiatry and neurology at
Pfizer, which makes Zoloft, said it had sponsored two trials in
children. One had a negative result, but the company pooled it
with a positive study and only published the combined result,
which was positive...
Graham Emslie, a professor of psychiatry at the University of
Texas
Southwestern Medical Center, who has helped conduct several trials
for drug companies, counted nine recent trials of Prozac, Paxil,
Zoloft and Celexa in depressed children. Results of two Prozac
trials, one Paxil and the pooled Zoloft data have been published
-- meaning that data from five trials, including the stand-alone
Zoloft trial that was negative, have not.
Emslie also counted six other studies on the related
antidepressants Effexor, Serzone and Remeron -- none of which has
been published, he said...
David Healy, a Welsh psychiatrist and author of "The
Antidepressant Era," rejected the notion that the safety
information could be treated like any
other private property. Healy prescribes the medicines but has
campaigned for more cautious use and more accurate labeling.
"On a pressing issue like this," he said, "there is no reason
these data
could not be put into the public domain in their entirety."
The FDA said it is evaluating 20 studies in all, but agency
officials have declined to identify them.
In the end, some scientists believe, the only way to ensure that
science is
conducted in the public interest is for it to be funded with
public dollars.
The National Institutes of Health is therefore ramping up funding
for clinical
trials.
"We have been dependent on the pharmaceutical industry to provide
the
answers," said Thomas R. Insel, director of the National Institute
of Mental Health. "The questions they want answered are different
than the public health questions."
_ The Washington Post Company
Common antidepressant medication drugs work artificially to
selectively enhance and mimic Serotonin activity within the brain.
Unfortunately antidepressant medication can cause a number of
negative and potentially harmful side effects. On the other hand,
Deprex is
completely safe and can naturally enhance Serotonin levels within
the body and brain - all without side effects common in synthetic
antidepressant medication.
And remember, Deprex is all natural, safe and highly effective.
Back to "Child Depression
and Antidepressants Use"
