ctldecision.pdf

The court ruled,

“Appeal Denied”.

Kerry is very sorry we could not win this for the patients suffering with AIPC. “We will take the fight to the Supreme Court but we understand that this is not timely enough for many thousands of suffering men.”

We are unripe. We are in FDA limbo. We haven’t been denied a license, yet you can’t get Provenge, but it is not denied, just delayed a few years. To our fathers, husbands, sons and brothers who have passed away, it is as final as anything can get. The FDA needs to be disbanded and the patients rights given back to the patients and not the corporations, and “venture capitalists.”

Unconscionable!

We fight on!

Next Stop

Kerry Donahue, our lawyer extraordinaire, has incredible fortitude to pursue this fight on behalf of men with late stage prostate cancer. The Courts are passing this hot potato up the hill. Kerry has filed a lawsuit on behalf of CareToLive to try to get men with late stage prostate cancer access to Provenge, a safe, non toxic, non invasive immunotherapy. Somebody needs to get the ear of the right fat cats on the hill, exchange a few suitcases of cash, no, wait a minute, that would be illegal. We have men we love who need Provenge NOW! Approve it because it is the right thing for a civilized society to do. Visions of Soylent Green come to mind.

FEAR NOT!

MOTION TO THE SUPREME COURT TO REVIEW Coming Soon!

Kerry, We LOVE You. You are doing an incredible job. You stand among America’s finest. Your amazing work on behalf of men with late stage prostate cancer is unrivaled!

http://caretolive.com/lawsuit-news/

The courts are part of the system, pushing us aside, shutting off another route to redress. We will stay in their face. What choice do we have.

Ted needs Provenge NOW!

http://www.youtube.com/watch?v=6Q0uQAL_YDA

http://www.youtube.com/watch?v=UqAx7uZAS90

THE CAN CAN
http://www.jibjab.com/starring_you/receipt/2111682

Popularity: 18%

If you haven’t yet had a chance to read the FOIA response from the National Cancer Institute, read it here.

Popularity: 26%

The poster “emrssf” did a very good job of conveying to everyone here the environment at the oral argument. While it is not entirely accurate or complete (he states at the beginning that he does not take shorthand and so it is not presented as entirely accurate) it is close to accurate and in fact it helps me to recall the chronology of events better than I could without it. While he was taking notes on what was being said I was focused on responding to the Judges questions and anticipating my next argument. So I cannot be entirely accurate or complete either.

Continue Reading Where it stands…CareToLive vs. FDA (long winded version) »

Popularity: 25%

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

Popularity: 36%

The Sixth Circuit Court in Cincinnati, Ohio has granted the request of CareToLive to present oral argument in Appeal No. 07-4465 which is the appeal of the Southern District of Ohio Court decision (case # 07-729).

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

Argument will be before a three judge panel. The identity of the three judge panel will not be identified until two weeks before the oral argument date.

Also, Thanks to all the participants that helped make the first ever Coast to Coast prostate cancer demonstrations a huge success!

Continue Reading CareToLive v. FDA — Sixth Circuit Court Grants Oral Argument in Appeal! »

Popularity: 45%

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

Popularity: 39%

ctlmemocontrleavefor-admissions.pdf

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In response to the FOIA complaint filed by CTL motion that CDER just does not have the time and resources to locate and process the request.

ctlmemocontrastaykerry5pdf2.pdf

Way to go Kerry!! THANKS!

Popularity: 37%

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.

Popularity: 39%

FIGHTING FOR THE RIGHTS OF THE MEN WITH PROSTATE CANCER THAT THE FDA, DR. HOWARD SCHER & DR. MAHA HUSSAIN COULD CARE LESS ABOUT.

excerpt:

The FDA, with the help of a slew of in house attorneys, has created a labyrinth of regulations, all designed to avoid oversight and minimize due process. One of the latest creations of the FDA is the Complete Response Letter (“CR”), which is a very important, yet still unseen document in this litigation. In the magical world of the FDA they have created a mechanism that Houdini would be proud of. They turned a functionally final decision, into a self declared non-final decision. The issuance of the CR letter, that essentially is believed to say come back and see us in one, two, three or more years, when, or if, you get more data, is no different in application or in function than an outright denial of the application, yet the FDA forces people to accept their contrived definition, which is that a “Complete Response” letter is not a “final response” or even a decision, and that there is still an ongoing process, as they might still approve the application sometime in the nebulous future. In Provenge’s case, the CR letter operates to the applicant, the dying patients, the patient’s families, and everyone else waiting for the treatment, as a complete denial. A CR letter is just the latest fiction created to avoid oversight. Continue Reading KERRY DOES IT AGAIN! OUR APPEAL REPLY IS FILED!! »

Popularity: 40%