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%40justiceseekers.com">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.
.