Fwd: [drugawareness] URGENT APPEAL FOR ALL THOSE HARMED BY SSRIs

[Guest guest]

: " Mark Miller "

Sat, 21 Jun 2003 16:47:57 -0000

[drugawareness] URGENT APPEAL FOR ALL THOSE HARMED BY SSRIs

 

 

 

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.

 

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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Or, go to our group site: Gettingwell

 

 

 

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