Kerry Donahue, Attorney CareToLive

Oral arguments
July 29th at 1:30 pm
Potter Stewart United States Court House
100 East Fifth St., Cincinnati, Ohio

The Sixth Circuit Court in Cincinnati, Ohio
Appeal No. 07-4465
Southern District of Ohio Court decision (case # 07-729)

Today the FDA sent a Federal Rule of Appellate procedure 28 letter to the Sixth District Court which you can review here.
caretolive-defs-rule-28j-letter-20080716.pdf

Our Counsel then filed a response seen here
ctlfdarule28-responsea.pdf

and his own Rule 28 letter with attachments, seen here
cctlfdarule28jlettera.pdf

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Please join us for our Nationwide Protest of the FDA On May 30th. See details here ctlnatlprotest9.pdf and also visit our rally page for additional details http://caretolive.com/rally/ .

Video of the 2007 Rally at the FDA http://www.youtube.com/watch?v=UqAx7uZAS90

We are protesting the terrible decision to deny Ted Girgus and thousands of other men like him with end stage prostate cancer ted-girgus-ad1a.pdf

Ted’s Doctor wants Ted on Provenge NOW!

1 in 6 men get prostate cancer. 27,000 American men die from it every years. Provenge is an immunotherapy that harnesses the bodies healthy cells and retrains them to target the cancer.

On May 28, 2007, in an unprecedented and horrendous decision, the FDA decided to delay treatment to these men.We would like to take a few moments to remember two of our CareToLive members who have passed away since the FDA turned its back on the men without explanation or cause.

We tried to get Congress to hold hearings over the shenanigans that went on at the FDA that day, including conflicts of interest with competing drugs, “leaked letters” and the corruption that took place at the dysfunctional FDA.

Congressman John Dingell (Michigan) and Frank Pallone (New Jersey) decided against a Congressional hearing for all the wrong reasons. You can read their response to those calling for hearings.

They prefer to leave these men seeking Provenge in FDA purgatory. It is over a year since denial of Provenge licensure but the FDA claims the decision is not final, it is just a delay. Congress says they won’t hold hearings because the decision is still pending. Tell that to our Ted Girgus. 2/13/08.

Here is Dingell and Pallone’s passing the buck. micha001.pdfThree Congressmen, Mike Michaud (D) of Maine, Dan Burton (R) of Indiana, and Tim Ryan (D) of Ohio called for a congressional hearing into the conflicts of interest and what went wrong at the FDA causing the delay of Provenge. (click this link) Read the Congressional Letter calling for a Hearing 12/13/07.

It is over a year and so many of our members, like Ted Girgus, who is desperately seeking Provenge, could be on Provenge NOW, getting the benefits that people like Eduardo Garcia and Bruce Tower received, two men who participated in the Provenge trials and are both still around to tell.

Come on Congress. Come on FDA. Do the right thing. APPROVE PROVENGE NOW!

Support the ACCESS ACT CareToLive Member Stephen Study’s son writes about the passing of his fatherwho was never given the chance to receive Provenge“I’ll Never forgive the FDA for what they did to Dad” (click to read)part IIhttp://caretolive.com/wp-content/uploads/2008/04/caretoliverockvillegazette4ad-part-2web.pdf

Also please support the ACCESS ACT! http://www.pharmalot.com/2008/05/a-bill-for-experimental-meds-for-terminally-ill/

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JOIN US

VISIT OUR RALLY 2008 PAGE. http://caretolive.com/rally/

HOPE TO SEE YOU AT THE RALLY!!

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On Wednesday, April 16th, we wanted to beat the Pope mobile and his crowd so we left early and arrived in Rockville at 4:30 AM. At 4:45 plenty of FDA people had already reported for work and the parking lot was 1/3 full. We decided to protest earlier than the 7 AM we had originally planned.

We went and grabbed some coffee and got our signs ready and started protesting at 5:45. We were able to give out our latest ad and some copies of the Rockville Gazette which the folks took inside the FDA Building.

We were able to raise some more awareness as we shouted things like:

Extra! Extra! Read all about it!
Another CareToLive member has died.
Read his son’s sad story in Today’s Rockville Gazette!
The FDA hasn’t responded to our Citizens Petition!
The FDA hasn’t turned over all the documents we requested under the Freedom Of Information Act!
This is an emergency, FDA!
83 Men Die every day in America from prostate cancer!
Help us out FDA!!

Click here to see the video!

A third CareToLive member joined us at 7 AM. The three of us handed out all of our copies of the ad, Continue Reading CareToLive Returns To Rockville »

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4/16/08 The Care To Live Awareness Campaign in the Rockville Gazette, continues to confront the FDA to address our Petition for the FDA to Reconsider their decision to delay Provenge in what was an unprecedented action by them to delay a treatment in an end stage disease where no other options exist, despite the fact that Provenge was voted 17-0 Safe and 13-4 Efficacious by an FDA Advisory Panel.

Please email, print and fax our ads to help increase awareness of the Provenge Debacle so we may reverse this tragedy. It is over a year since the Advisory Panel was convened. 30,000 American men die each year of prostate cancer. 1 in 6 men will get prostate cancer in their lifetimes. We need better, safer treatments NOW! The FDA needs to address the needs of the men with end stage prostate cancer, and allow them access to the immunotherapy Provenge IMMEDIATELY!

Stephen H. Study Died without ever receiving Provenge. Shame on those individuals at the FDA responsible for this genocide. They are so concerned about selling men drugs to enhance their sex lives, and have completely ignored the real needs of our men, the approval of drugs that have prolonged survival. Some men who received Provenge in trials are alive 6 years longer.

Week #3 Color Ad caretoliverockvillegazettesstudyad3a.pdf

Week #3 Black & White Ad caretoliverockvillegazettesstudyad3abw.pdf

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This is Week #3 of our “In Your Face” Rockville Gazette Advertising Campaign to raise awareness to the tragedy that is taking place in the prostate cancer community. While 83 men die every day of prostate cancer, the FDA sits on our Petition, and refuses to reverse their fatal decision to delay Provenge to the 30,000 men who might have benefitted from it, each year.

Continue Reading We’re Going Back To The FDA Tomorrow Wednesday 4/16/08 »

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Watch for Our Return to Rockville this week.

CareToLive Demonstrates at FDA 4/2/2008 (video & recap)

Russia Approves World’s First Cancer Vaccine
http://www.reuters.com/article/marketsNews/idUSN0728116320080408

6 Videos

Care To Live kicks off its new awareness campaign advocating for men with prostate cancer.

The Drive to the FDA in Rockville
http://youtube.com/watch?v=4PtSyK_5hp8

Continue Reading SHAME ON THE FDA: Russia Approves World’s First Cancer Vaccine & 6 Videos of the CareToLive 4/2/2008 FDA Demonstration & RECAP »

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WEEK #2

Week 2 Ad Color caretoliverockvillegazette2ad.pdf

Week 2 Ad Black & White caretoliverockvillegazette2adbw.pdf

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CareToLive Ad Full Page Color 8.5 ” x 11″ (click here)

CareToLive Ad Full Page Black and White 8.5″ x 11″ (click here)

1/2 Page Rockville Gazette Newspaper Ad (Actual Size) 5.638″ x 11″ (click here)

Copy of this 4/2/08 Press Release (click here)

FOR IMMEDIATE RELEASE

ADVOCACY GROUP “CARE TO LIVE” BEGINS LATEST CAMPAIGN

CareToLive Continues To Enlighten the World to the Dastardly Deeds of the FDA

Starting today, Wednesday April 2, 2008, CareToLive has begun the process of placing weekly advertisements in the Rockville Gazette, in Rockville, Maryland. These ads will contain letters from patients, families of patients or physicians. New letters will appear each week until the FDA does the humane thing and approves Provenge for the patients. The letters will also be distributed by volunteers on the streets of Rockville and on the internet.

CareToLive highlights the FDA’s blatant refusal to allow access to Provenge to men who are dying from late stage prostate cancer.

The letters will be heartfelt appeals to the humanity of the FDA, who even now, after being provided with the evidence that the Provenge BLA process was corrupted, do nothing to remedy it.

The FDA continues to refuse to follow its own rules regarding Citizens’ Petitions and refuses to comply with the Freedom of Information Act. Eighty four (84) men die every day while the FDA argues it needs 20 more months to provide simple documents to CareToLive and more than 8 months have passed without action on the CareToLive Citizens’ Petition.

First the citizens of Rockville, the home of the FDA, will further awaken to the travesty that occurred in their town that resulted in the denial of Provenge to 26,000 AIPC patients who have since died. Next the world will know.

More at www.CareToLive.com.

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13 pages of Freedom of Information (FOIA) documents received from Commissioner von Eschenbachs office concerning the Provenge License Delay for Prostate Cancer Debacle 3/5/2008.
READ THEM HERE
foi-docs-recvd-3-4-08.pdf

If you recall on 1/30/08 we were told there were no documents from Andy.
FOIA denial that Andrew Von Eschenbach received any documents concerning the “leaked” letters despite the fact that Dr. Scher & Dr. Maha Hussain CC’ed Von E their letters prior to “leaking” them. 1/30/08 (click this link)

See the research page of CareToLive for other Freedom of Information documents we received.

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