Dendreon announced updated results today from its pivotal Phase 3 IMPACT trial for late stage prostate cancer. The results were even better than we expected. According to Dendreon, the study “demonstrated that PROVENGE increased three-year survival by 40 percent compared to placebo.”

This is truly awesome and in line with what we always believed about the potential of Provenge and Immunotherapy. Dr. Phillip Kantoff, the Director of the Lank Center for Genitourinary Oncology, Chief of the Division of Solid Tumor Oncology, and Chief Clinical Research Officer at Dana-Farber Cancer Institute, Professor of Medicine at Harvard Medical School, and principal investigator of the IMPACT study, said it best:

“The results from the IMPACT study corroborate earlier studies with sipuleucel-T in demonstrating an improvement in overall survival for men with metastatic castration resistant prostate cancer.”

This is why CareToLive, represented by our attorney, Kerry M. Donahue, fought so long and so hard to keep Provenge in the limelight after the FDA delayed approval for almost 3 years to date.

The earlier studies which were reviewed by an FDA Advisory Committee back in March 2007 demonstrated survival, the FDA gold standard for approval of cancer treatments, especially for terminal patients who had no other options, yet we are still awaiting approval.

Dr. Kantoff reminded us that we are seeing medical history:

“This is the first therapeutic vaccine to demonstrate a survival benefit in cancer.”

This goes way beyond prostate cancer because Dendreon is going to use similar treatments to try to tackle other cancers, such as breast,  colon , ovarian cancer, etc.

Although safety was never a concern in prior trials, rumors abounded, and today, Dr. Kantoff, in the press release, tames that concern while reiterating the medical history we are about to experience:

“Furthermore, the results of this study validate cancer immunotherapy as an entirely new treatment paradigm that can provide patients with a clinically meaningful survival benefit coupled with a well-tolerated safety profile.”

CareToLive is thrilled to proudly broadcast this great news.

The three-year survival by 40% compared to placebo is record breaking. Now we need the FDA to  enable the men in dire need to get Provenge ASAP!

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When looking at The Freedom of Information Act [5 USCS § 552], notice what it states in Section 3:

B) Each agency shall make reasonable efforts to maintain its records in forms or formats that are reproducible for purposes of this section.

C) In responding under this paragraph to a request for records, an agency shall make reasonable efforts to search for the records in electronic  form or format, except when such efforts would significantly interfere with the operation of the agency’s automated information system.

(D) For purposes of this paragraph, the term “search” means to review, manually or by automated means, agency records for the purpose of locating those records which are responsive to a request.

The FDA responded to this by saying such a search for documents sent to and from Richard Pazdur would be complex. Then the FDA mistakenly told the court that such a request would be too costly, not realizing the requester pays for it.  After the search was completed, Richard Pazdur simply declared that he deleted and shredded the documents two years ago and CareToLive had to pay 40 cents for this complex search! 40 cents!

You can’t even purchase one of these for 40 cents!

Sadly, the Court in the Southern District of Ohio ruled in favor of FDA.

CareToLive’s fine attorney, Kerry M. Donahue, filed an appeal this past August and last night he filed our Appellate brief (Appellant’s brief) which is our written argument for the 6th Circuit Court of Appeals which they will review and then probably set up for oral argument.

The FDA (Appellee) has 15 days to file their response, but we would not be surprised if they get an extra 2 weeks after that if they need it.

You can read the brief here>>   ctlappealfoia11172009pdf.pdf

Here are some highlights:

“The Appelle has consistently argued that the Provenge matter is still an “ongoing process” so the destruction of documents regarding an ongoing process demands further inquiry.“

“Either way the FDA did not perform the “complex” search that it promised the Court and Appellant that it was conducting.”

“The search time incurred by the FDA CDER division FOIA office was so slight that it did not even register on the radar as a significant reportable/billable search time. That was the entire “complexity” of the search and response.”

“…the FDA told inquiring members of Congress that they did in fact conduct an internal investigation.”

” It does not cost the Defendant anything!“

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Michael Milken, 60,000 Deaths, and the Story of Dendreon (Chapter 1 of 15)

18 June 2009 by Mark Mitchell

What follows is part 1 of a 15 part series. The remaining installments will appear on Deep Capture over the next several weeks, after which point the story will be published in its entirety. It is a story about the travails of just one small company, but it describes market machinations that have affected hundreds of other companies, and it contains a larger message for anyone concerned about the “deep capture” of our nation’s media and regulatory bodies.

This story, like too many others, begins with Jim Cramer, the CNBC personality, making “a mistake.”

On September 26, 2005, Cramer  announced to his television audience the sad news (punctuated by funny sound effects – a clown horn, a crashing airplane) that Provenge, an experimental treatment for prostate cancer, had flopped. Thousands of end-stage patients had been pinning their hopes on Provenge, but according to Cramer the treatment had just been rejected by the Food & Drug Administration. It would never go to market.

Read It Here >>http://www.deepcapture.com/michael-milken-60000-deaths-and-the-story-of-dendreon/

http://www.DeepCapture.com

http://www.deepcapture.com/michael-milken-60000-deaths-and-the-story-of-dendreon-chapter-1-of-15/

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It is over 7 months since the FDA denied the Provenge Biologics License Application for Prostate Cancer. Last week John Fish, suffering from late stage prostate cancer, was admitted to a hospice without ever having been given the opportunity to receive this immunotherapy to try to strengthen his body to fight for his life. John has however, joined with CareToLive and hopefully although it may be too late for him, he and his wife Marlilyn have courageously stood toe to toe with us, along with many of our other members with prostate cancer, to try to make this treatment available for the rest of the 30,000 men who will surely die this year without it.

Finally! Thanks to the efforts of CareToLive, a non profit, led by attorney Kerry Donahue, and Scott Riccio of ARightToLive, and the many, many members and supporters of CareToLive and Provenge, an immunotherapy voted overwhelmingly safe and effective by an FDA panel of experts to approve this treatment for prostate cancer, and then denied without adequate explanation by the FDA, three of our congressmen, Mike Michaud of Maine, Dan Burton of Indiana, and Tim Ryan of Ohio are asking for a congressional hearing into what happened. We must continue to be vigilant and to contact our representatives in the Congress to keep the pressure on, and to demand a congressional hearing.

CONGRESSIONAL LETTER ASKING FOR A HEARING  PDF (click here) Please fax this letter to your own congressional representatives and ask them to join this action. TIA

An Easy Way To Contact Your Elected Officials - (click here) EVERY VOICE COUNTS!

This is a grassroots movement. We need EVERYBODY’S help. See you at the hearings!

Please visit our website and read our blogs to learn about the 3 “leaked” letters and so much more, Continue Reading The FDA Said NO, CareToLive & ARightToLive say GO FISH! »

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