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Posts Filed Under ‘The Lawsuit’
LATEST POSTS
- 10/09/2008 - What is a Life Worth?
- 09/08/2008 - CareToLive Strikes Back!
- 08/28/2008 - CareToLive Continues Fight for Prostate Cancer Patients Rights!
- 08/15/2008 - THE STONEWALLING CONTINUES
- 08/04/2008 - NCI FOIA Response
- 08/04/2008 - Where it stands…CareToLive vs. FDA (long winded version)
- 07/25/2008 - Ed Silverman from Pharmalot Bags It!
- 07/23/2008 - 7/23/08
- 07/17/2008 - The Battle Continues — The Parties Jocky for Position Headed into Oral Argument
- 06/18/2008 - Please Sign the Petition for the Access Act
MOST POPULAR
- The FDA is uncaring, the world won’t change their thought process and meanwhile Congress remains asleep at the wheel, when it comes to Provenge for the terminally ill.
- Sleepless in Asentar
- Michael Milken and the Prostate Cancer Foundation's Foul Balls
- Are Congress and the FDA missing the big picture?
- Supplemental Memorandum Plaintiff CareToLive
- Corruption at Its Finest
- The Time is NOW!
- 3 "Leaked" Letters & So Much More
- Get On The Bus Gus!
- The FDA Is Out Of Control
WHATS GOING ON
This Is An Emergency!
We rallied outside the FDA building in Rockville, Maryland on September 18th. Now there are buses riding around Rockville and Washington, D.C., further protesting the shenanigans that took place inside the FDA building, as well as outside.
The FDA has gotten caught up with Wall Street. While it is supposed to be busy with evaluating food and drugs, its employees just can't keep their eyes off the money. So that is how decisions are being made these days.
This Is An Emergency!
We rallied outside the FDA building in Rockville, Maryland on September 18th. Now there are buses riding around Rockville and Washington, D.C., further protesting the shenanigans that took place inside the FDA building, as well as outside.
The FDA has gotten caught up with Wall Street. While it is supposed to be busy with evaluating food and drugs, its employees just can't keep their eyes off the money. So that is how decisions are being made these days.
WE'LL BE BACK
These people traveled from all across the country to protest outside the FDA Building in Rockville, Maryland. The FDA has stopped a safe and effective treatment from getting to men who need it now. The treatment is called Provenge and it treats men who have late stage prostate cancer.
The FDA appointed a panel of experts to help it decide on the safety and efficacy of Provenge. That panel voted 17-0 that Provenge was safe. And it voted 13-4 that Provenge showed substantial evidence it worked. And yet the FDA delayed it. Now it could be a year, a year and a half or it could be three years. It could be forever.
These people will keeping coming back to Rockville and they hope others will join them until the courts, the FDA, Congress or somebody does something about this travesty.
These people traveled from all across the country to protest outside the FDA Building in Rockville, Maryland. The FDA has stopped a safe and effective treatment from getting to men who need it now. The treatment is called Provenge and it treats men who have late stage prostate cancer.
The FDA appointed a panel of experts to help it decide on the safety and efficacy of Provenge. That panel voted 17-0 that Provenge was safe. And it voted 13-4 that Provenge showed substantial evidence it worked. And yet the FDA delayed it. Now it could be a year, a year and a half or it could be three years. It could be forever.
These people will keeping coming back to Rockville and they hope others will join them until the courts, the FDA, Congress or somebody does something about this travesty.
CareToLive Continues Fight for Prostate Cancer Patients Rights!
August 28th, 2008 | Posted by Rory Kearneyctldecision.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%
Tags: andy von eschenbach, Dendreon, frank lautenberg, Howard Scher, Janet Woodcock, Jesse Goodman, Kerry Donahue, maha hussain, michael milken remains silent, prostate cancer foundation still silent, provenge, Richard Pazdur
Posted in The Cause, The Lawsuit | 1 Comment »
NCI FOIA Response
August 4th, 2008 | Posted by CTLIf you haven’t yet had a chance to read the FOIA response from the National Cancer Institute, read it here.
Popularity: 26%
Tags: foia response, NCI
Posted in The Cause, The Dysfunctional FDA, The Lawsuit | Post a Comment »
Where it stands…CareToLive vs. FDA (long winded version)
August 4th, 2008 | Posted by Kerry DonahueThe 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%
Tags: oral arguments
Posted in The Lawsuit | 2 Comments »
The Battle Continues — The Parties Jocky for Position Headed into Oral Argument
July 17th, 2008 | Posted by CTLKerry 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%
Tags: Andrew Von Eschenbach, Care To Live Appeal, CareToLive, Dendreon, DOJ, FDA, Kerry Donahue, Prostate Cancer, provenge
Posted in The Dysfunctional FDA, The Lawsuit | 3 Comments »
CareToLive v. FDA — Sixth Circuit Court Grants Oral Argument in Appeal!
June 4th, 2008 | Posted by CTLThe 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%
Tags: AIPC, Alison Martin, Brachytherapy, Cancer Vaccine, Care To Live, CareToLive, Chemotherapy, commissioner Andrew Von Eschenbach, Dendreon, FDA, foia, Freedom of Information Act, hormone refractory, Howard Scher, Immunotherapy, Jesse Goodman flubs it, Kerry Donahue, maha hussain, Memorial Sloan Kettering, Michael Milken sadly remains silent, Mike Milken, oncologist, Prostate Cancer, Prostate Gland, Prostatectomy, provenge, Richard Pazdur, Rick Pazdur, Robotic Surgery, Ted Girgus, The Prostate Cancer Foundation stays silent, Thomas R Fleming
Posted in The Cause, The Dysfunctional FDA, The Lawsuit | 5 Comments »
CareToLive Awareness Campaign Week #3 — We Are Very Sad To Announce Another Member Died — Part I
April 15th, 2008 | Posted by CTL4/16/08 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%
Tags: Andrew Von Eschenbach, Brachytherapy, Bruce Tower, Care To Live, CareToLive, Dendreon, FDA, Howard Scher, Kerry Donahue, Maha Hussein, Mike Milken, Prostate Cancer, Prostate Cancer Foundation, provenge, radical prostatectomy, Stephen D. Study, Stephen H. Study
Posted in The Cause, The Dysfunctional FDA, The Lawsuit | 3 Comments »
REPLY TO DEFENDANT’S MEMORANDUM CONTRA PLAINTIFF’S REQUEST FOR LEAVE TO SERVE REQUESTS FOR ADMISSIONS UPON DEFENDANT
April 12th, 2008 | Posted by CTLctlmemocontrleavefor-admissions.pdf
Popularity: 32%
Posted in The Lawsuit | 3 Comments »
CareToLive Files Memorandum Contra in Response to FOIA Complaint in Response to FDA Motion to Stay
March 11th, 2008 | Posted by CTLIn 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%
Tags: Brachytherapy, Cancer Vaccine, Care To Live, CareToLive, commissioner Andrew Von Eschenbach, Dendreon, FDA, foia, Freedom of Information Act, Howard Scher, Immunotherapy, maha hussain, Michael Milken, Prostate Cancer, Prostate Gland, Prostatectomy, provenge, Richard Pazdur, Robotic Surgery, Thomas R Fleming
Posted in The Cause, The Dysfunctional FDA, The Lawsuit | Post a Comment »
Andy Comes Clean - Turns Over Freedom of Information Documents to CareToLive
March 5th, 2008 | Posted by CTL13 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%
Tags: Andrew Von Eschenbach, Care To Live, CareToLive, Dendreon, FDA Commissioner Andy Von Eschenbach, howard i scher, Immunotherapy, maha hussain, Prostate Cancer, provenge, Thomas R Fleming
Posted in The Cause, The Dysfunctional FDA, The Lawsuit | 1 Comment »
KERRY DOES IT AGAIN! OUR APPEAL REPLY IS FILED!!
February 28th, 2008 | Posted by CTLFIGHTING 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%
Tags: Andrew Von Eschenbach, Bellinger & Donahue, Dendreon, FDA, Howard Scher, Immunotherapy, Kerry Donahue, maha hussain, Prostate Cancer, provenge
Posted in The Cause, The Lawsuit | 2 Comments »