[drugawareness] An Appeal for Help from Andy Vickery

[Guest guest]

" Mark Miller " <mmiller18

Sat, 23 Jul 2005 02:17:29 -0000

[drugawareness] An Appeal for Help from Andy Vickery

 

 

 

 

 

Here is an urgent appeal from a gallant warrior in the cause of bring

antidepressant

makers to justice for their failure to warn. Houston Attorney Andy

Vickery is representing

the family of 15-year old Shyra Kallas who shot herself after one

month on Zoloft. (She

saw her doctor for warts! See end of this email for her story.)

 

Seems the federal judge in the Kallas v. Pfizer case has issued an

order inviting the FDA to

submit a new " amicus " (friend of the court) brief on whether they

would have permitted

Pfizer to issue a warning about the " association " between Zoloft and

pediatric suicidality.

 

FDA response is due 8/1/05.

 

Here is Andy's plea:

 

" NOW, one would think that, since the FDA Alert posted on their

website says that 1 out of

50 kids taking Zoloft become suicidal (or have increased

" suicidality " ) " DUE TO DRUG " that

this one would be a no brainer. One would THINK that the FDA would

say, " absolutely.

Not only would we have permitted it, but, once we looked at all of the

Zoloft clinical trial

data very carefully – DATA that clearly predates 15 year old Shyra

Kallas's death – we

required Pfizer to issue a BLACK BOX WARNING about that very risk. "

That's what one

would think.

 

HOWEVER, this is the Bush Administration we are talking about.

Remember Dan Troy and

the famous amicus brief in the Motus case? (Which, incidentally, the

federal judge in Kim

Witczak's case just blew completely out of the water day before

yesterday) This is the

Administration that would like to see legislation nationwide like they

have in Michigan – " if

the FDA has approved the drug, you can't sue the mfr. End of story.

Tort elimination,

not reform. "

 

My concern is that, unless they feel the heat of congressional

watchdogs, media guard

dogs, and the bite of family dogs, that they could try to slip one by

us. And its harm

would not just be limited to Ken and Angela Kallas.

 

SO, what can we do?

 

EACH of you with a story to tell can tell it ASAP in writing to the

Commissioner of the FDA,

with cc's to Chief Counsel, to Bob Temple, and to your congressmen and

Senators. You

can tell them that, although we applaud the May 2005 " due to drug "

ALERT, we certainly

hope that this Agency, founded on a charter to protect consumers, will

not, once again,

throw in its lot to protect Pfizer.

 

THOSE OF YOU with political or media connections can do everything in

your power to

make sure that the decision that the FDA makes is made in the FULL

LIGHT OF THE DAY

and that, if they choose to screw consumers once again, they will pay

a heavy, heavy price

for it. "

 

To help in your efforts, I have included the email address of top FDA

and Health & Human

Services officials. Please email them with your story and urge the

FDA stay true to its May

2005 Alert.

 

Thomas Abrams

abramst

 

Ann Agnew

Ann.Agnew

 

Lester Crawford

LCRAWFORD

 

Steven Galson

steven.galson

 

Russell Katz MD

katzr

 

Sandra Kweder

sandra.kweder

 

Dianne Murphy MD

mmurphy

 

Paul Selgiman

paul.seligman

 

Robert Temple MD

temple

 

Janet Woodcock MD

woodcockj

 

Gratefully, your friends at the ICFDA

 

Shyra Kallas:

 

Shyra Kallas is one among all too many tragedies that should never

have happened.

According to a complaint filed in US district court of Utah against

Pfizer [2], on October 8,

2002, Shyra, aged 15, went to see her family physician for warts. In

the course of relating

her history, Shyra indicated that she had been having trouble sleeping

and felt

" overwhelmed " with schoolwork. The suit notes: " Her doctor then did

precisely what

Pfizer's salesmen regularly encourage doctors to do, i.e., he (a)

diagnosed " depression "

and (b) prescribed Zoloft. " It was an " off-label " prescription. There

was no warning on the

label.

 

According to the suit, on her follow-up visit with her doctor on

October 29, Shyra reported

that she was " irritable " and that she continued to have significant

problems sleeping. The

doctor failed to realize that the irritability could be drug-induced,

and indeed could be an

early warning sign for incipient suicidality. The doctor told Shyra

her to continue taking

her Zoloft pills. On November 4, 2002, Shyra shot herself to death.