CareToLive has received an answer from the FDA to our Complaint that the FDA has not been forthcoming with all of the Freedom of Information (FOI) documents that we requested and are entitled to under the Freedom of Information Act (FOIA). Our Attorney Kerry Donahue will attend a Pretrial Hearing on March 5, 2008.

CareToLive requested all documents, letters, emails and /or correspondence from the National Cancer Institute (NCI) to the FDA or those acting as advisors to the FDA, concerning the BLA filed by Dendreon Corporation for fast track appproval of Sipuleucel-T, known under its marketing name of Provenge between January 1, 2007 and May 30, 2007. We seek to understand the role that the NCI played with regards to the process that resulted in the non approval of Provenge on May 9, 2007. We also requested all information pertaining to the roles played by Dr. Scher, Dr. Hussain and Dr. Fleming including Alison Martin and anyone else at NCI in regards to the FDA decision or with those working with the FDA, as as Scher, Hussain and Fleming.

CareToLive also requested all letters written to the FDA or prepared by the FDA and purported to be from Dr. Scher, Dr. Hussain and Doctor Fleming between March 29, 2007 and April 30, 2oo7 regarding the BLA submitted for Provenge, including the envelope or other means of communication whereby the FDA received such letters and a copy af any record for those letters then being disclosed to any media or other persons or specifically a publication call “The Cancer Letter”, including the means of communication of the Cancer Letter of the Scher, Hussain and Fleming letter from the FDA or its employees to outside persons, publications or companies.

CareToLive vs. FDA, Commissioner Andrew von Eschenbach
Complaint for Violation of Freedom of Information Act
ctlfoiacomplaintfinalfiled.pdf

Defendant FDA’s Answer to CareToLive Complaint for
Violation of Freedom of Information Act 2/4/2008
ctlfoiafdaanswer.pdf

PreTrial Hearing Scheduled March 5, 2008 3:30 PM
ctlfoia-pre-trial.pdf

Here is everything we have received to date.

Scher
(we received 2 hard copies)
Dated Thurday April 5, 2007.
Von Eshchenbach’s copy has his name across it — Andrew
Witten’s is stamped received Tuesday April 10, 2007
We did not receive the hard copies he CC’ed to Goodman, Pazdur or Mule.

Email Friday April 6, 2007 5:23 PM
Scher emails his letter to Goodman. (He attached his letter. The attachment is addressed to Woodcock. This is the only email we have with the Scher’s 1st version of the question (Do the data show significant benefits?) However for some reason we have 2 page 2’s and we are missing at least a page 1 and it appears that this email is pieced together from 2 different emails, so we don’t really know who alls email it is.

On version 3 previously received of Scher’s letter April 3, 2007, which was edited by Alison Martin of the NCI, possibly with the help of Howard Streicher who we were told attended the meeting but did not take notes, the paragraph about the bastardized efficacy question does not exist at all, however it was later inserted in his final version.

Email Monday April 9, 2007 10:49 Am
Scher Emails Goodman again. “One last thing, I noticed an error in the letter on page 4 of my letter with regard to the change in the question which I will correct in the hard copy that is being forwarded.”

However Scher’s hard copy of his letter is dated April 5, 2007 and it contains the correction yet he did not tell Goodman that he was making the correction until Monday April 9th and that a hard copy would follow.

“Leaked” to The Cancer Letter Friday April 13, 2007
_______________________

Hussain

Email (we received 1 copy)
The PDF of her letter is attached to her email.

Monday, April 23, 2007 5:28PM
To:
Von E, Witten, Woodcock, Goodman, Pazdur,
CC’ed to herself and Mule

Hard Copy (we received 1 hard copy) Dated Monday, April 23, 2007,
Dear Drs.,
she sent it to
Von E, Woodcock, Witten, Goodman, and Pazdur.
We do not know whose copy we got except that we can rule out Pazdur as he is still looking but we can be pretty certain all parties received it.

Mathew Herper writes about Hussains letter in Forbes Thursday April 26, 200712:08 PM prior to The Cancer Letter publication.

“Leaked” to The Cancer Letter Friday, April 27, 2007

_____

Fleming

Email (we received 1 copy) (sent from Goodman to Binkley August 16, 2007)
The PDF of his letter is attached to his email

Monday, April 23, 2007 at 12:56 PM pst
To: Goodman, Woodcock, Midthun, Witten, Foulkes,
cc’ed to himself
Dear FDA Colleagues,
It is not my intention for this letter to be only a private conversation. I am willing to have this letter made public.

Hard Copy (we received 1 hard copy)
Dated April 20, 2006(7)
Dear Dr. Goodman
cc’ed: Woodcock, Mithun, witten, Foulkes

“Leaked” to The Cancer Letter Friday May 4, 2007

_______

Scher and Alison Martin’s version 3
Eschenbach, Woodcock and Goodman’s names at the top.

There are no page numbers on any hard copies
All page numbered sheets are from email

Version 3 Scher & Alison Martin
foia.pdf

more letters and email turned over to us
foialeakedletters.pdf

Popularity: 47%

Tags: , Alison Martin, Andrew Von Eschenbach, Care To Live, CareToLive, CareToLive vs. FDA, FDA, foia, Freedom of Information Act, Howard Scher, Howard Streicher, Kerry Donahue, maha hussain, National Cancer Institute, NCI, Thomas Fleming

This entry was posted on Wednesday, February 6th, 2008 at 11:46 am and is filed under The Cause, The Lawsuit. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.