On Thursday, June 19, 2003, the FDA, following the lead last
week of
the British MCA, ruled that Paxil should not be given to
kids 18 or under,
because of the increased risk of suicidal impulses.
There are several news stories on the Internet, but the most
reliable
source of information is on the official website,
www.fda.gov. You can
follow the links on that website to the story about their
action, and then
to their Q&A's and "contact us" feedback form.
Our main concern about the FDA's action, and particularly
about their
Q&A's, is two-fold:
(a) instead of acknowledging the wealth of information that
indicates
that this phenomenon affects adults as well as children,
they
specifically say that it does not -- people will die because
of that
advice;
(b) they focus only on Paxil. The truth is that this is an
SSRI class-wide
phenomenon. For example, if the FDA would only look at the
data in
Pfizer's May 1996 submission to them on suicidality
regarding children
and adolescents in the Zoloft clinical trials, they would
see (I) that the
suicidality data between Zoloft and placebo in that report
was at least
as damning as the newly revealed Paxil data, and (ii) that,
although
they tried to lay the blame for 7 of the 8 suicidal acts off
on other
"stressors", even Pfizer ADMITTED that Zoloft
triggered the self-
mutilation and suicide attempt of 8 year old "patient
#4".
Hopefully, with public and regulatory attention now focused
on the
problem, the FDA will pay attention to REAL human stories
from real
people.
WHAT YOU NEED TO DO
Please go to the FDA website, again at http://www.fda.gov, to follow
the links to their action about Paxil and 18 year olds, and
to click the
"contact us" button and then report the factual
details of your family's
tragedy. Keep it short and simple.
"My husband got Paxil or Prozac or Zoloft from a GP for
____.
Seventeen days later, he hanged himself in our back yard. He
was never
previously suicidal and this action was TOTALLY out of
character."
It is important in this regard that the FDA see how well
your story fits
the pattern of SSRI induced violence/suicide which Lilly
recognized way
back in 1990-91. Specifically, the phenomenon has four
distinctive
attributes: (i) the suicidality or violence came up
suddenly, almost out
of the blue, (ii) it was violent, (iii) there was an
obsessive or impulse
nature to the patient's actions, and (iv) it was out of
character (they
used the word "egodystonic"). Make your report to
them with those
elements in mind.
A copy of this email report could/should also be shared with
the
Senator Schumer's office in NY (http://schumer.senate.gov/
webform.html) and with the client's senators and
congressmen.
Also, please forward a copy of same to Mr. Andy Vickery, an
attorney
who has been successful in litigating a number of these
cases, at
andy justiceseekers.com.
A WORD OF CAUTION.
Families who have settled their legal claims have
continuing
confidentiality obligations. These do NOT preclude them from
sharing
the particulars of their tragedies with the FDA or members
of Congress,
or, indeed, if you choose, with members of the media
(contact us and
we will give you email address of appropriate media
representative).
However, NO MENTION should be made of a settled legal claim
or
lawsuit. IF you have a suit that is currently pending, you
might mention
the lawsuit but refer any inquiries about the case to your
attorney.
Finally, if an attorney is representing you but the case is
still in an
investigative stage, i.e. the claim has not been settled and
no suit has
yet been filed, then NO MENTION should be made of any legal
claim or
action.
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