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.

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

Popularity: 6%

CareToLive Attorney Kerry Donahue filed Plaintiff’s Reply to Defendant’s Memorandum in Opposition Plaintiff’s Motion for Leave to Conduct Discovery Under Civil Rule 56(f)

You can read the response here >> Response for Discovery

See Exhibit A >> exhibit-a-061609.pdf

See Exhibit B >> exhibit-b-061609.pdf

See Exhibit C* >> exhibitc.pdf

*Exhibit C — Taken from Demystifying Computer Forensics written by Johnette Hassell, Ph.D. and Susan Steen
CareToLive would like to thank the authors who were kind enough to let us use excerpts from their document — demystifying-computer-forensics.pdf . Johnette Hassell and Susan Steen are partners in Electronic Evidence Retrieval, L.L.C., a company specializing in computer forensics and other expert consultation and testimony in computer science. They have more than twenty years of experience in computer consultation and testimony, computer forensics, software and technical manual copyright infringement support, and programmatic research and evaluation. They can be reached at info@ElectronicEvidenceRetrieval.com or 504.483.0201 on the Gulf Coast and 970.922.7250 in the Rocky Mountain area. http://www.electronicevidenceretrieval.com/

Popularity: 8%

The Department of Justice (DOJ) submitted a brief on behalf of the FDA, in opposition to CTL’s Motion to conduct discovery (see second link)

You can read their entire brief here >> fdafoiamotion-memocontra-0613.pdf

* * * * *

CareToLive does not agree, and our attorney, Kerry Donahue, will be filing a response.

* * * * *

CareToLive MOTION FOR LEAVE TO CONDUCT/COMPLETE DISCOVERY UNDER CIVIL RULE 56(f)
AND PARTIAL MEMORANDUM CONTRA TO DEFENDANT FDA’S MOTION FOR SUMMARY JUDGMENT

Link to Motion >> ctlfoiaresponse6-06-09c.pdf

 * * * * *

Here are the FOIA Documents we received from CDER, requested by us almost 2 years ago in August of 2007, requesting FDA correspondence with Richard Pazdur concerning the Provenge delay of approval.

Freedom of Information reveals Dr. Pazdur searched both his paper and computer files and could not locate any documents responsive to plaintiff’s request.

Received 5/18/2009 Freedom of Information Act (FOIA) documents

Declaration of Richard Pazdur >> ctlpoaz29exbd-5.pdf

Defendant FDA’s Motion for Summary Judgment >> ctlsj29-1a.pdf

Declaration of Fredrick J. Sadler >> exba.pdf

Declaration of Nancy B. Sager >> ctlexhibitc3.pdf

Declaration of Beth Brockner-Ryan >> ctlryanexhibitb.pdf

From FDA, affidavit from Dr. Pazdur (above):
See id. at ¶ 6. Dr. Pazdur recalls receiving both hard
copies and electronic copies of the letters from Drs. Hussain and Scher in April 2007. See id. at  ¶ 7. However, as these letters related to a specific regulatory application conducted by a  different FDA Center (CBER), did not fall under his direct regulatory supervision, and did not  require a response from him, Dr. Pazdur shredded the hard copies of these letters and deleted any  electronic copies. See id. The documents were shredded and deleted within a month of receipt.  See id. In fact, Dr. Pazdur does not keep personal copies of any regulatory communications.  See id. at ¶ 8. Official copies of regulatory correspondence are kept in the official regulatory  document room of the specific center assigned to an application. Id.  Contrary to plaintiff’s suspicions, Dr. Pazdur never disclosed Dr. Scher’s or Dr.  Hussain’s letters to “any individuals outside of the FDA, or any media outlet, including a  publication called ‘The Cancer Letter.’” See id. at ¶ 9. In addition, he did not write any portion  of the letters that Drs. Scher, Hussain, or Fleming sent to the FDA. See id. at ¶ 10. He also never received a copy of a letter from Dr. Thomas Fleming to the FDA regarding Provenge. See id. at ¶ 11.

* * * * *

It took the FDA 2 years to deny the CareToLive Citizen’s Petition.

FDA’s Response to CareToLIve Citizens’ Petition >>  fda-response-to-citizens-petition.pdf

Popularity: 8%

MOTION FOR LEAVE TO CONDUCT/COMPLETE DISCOVERY UNDER CIVIL RULE 56(f)
AND PARTIAL MEMORANDUM CONTRA TO DEFENDANT FDA’S MOTION FOR SUMMARY JUDGMENT

Now Comes Plaintiff, CareToLive, on behalf of its members and all suffering late stage prostate cancer patients and their families who have now been denied a proven safe and effective treatment for over two years and request leave from this Court to conduct a limited amount of discovery so as to more fully respond to the Motion for Summary Judgment filed by Defendant, as further set forth in the attached memorandum.

Link to Motion >> ctlfoiaresponse6-06-09c.pdf

Popularity: 11%

The FDA blew a golden opportunity.

It took them 2 years of foot dragging to reach their decision on our CareToLive Citizens’ Petition.

They DENIED it!

The only redeeming factor in their pages of excuses, is that the FDA stated 3 times that they will process the amended Dendreon BLA expeditiously.

We at CTL feel the FDA lacks the compassion and the scientific ability to evaluate our Petition.

With the stellar Provenge survival data recently exhibited, we believe the FDA should have immediately reconsidered their death rattle.

Apr 28, 2009
Data Presented at AUA Demonstrate PROVENGE Significantly Prolongs Survival for Men with Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study (LINK)

The dysfunctional, omnipotent FDA has spoken loudly and clearly to the men with late stage prostate cancer who are out of options.

You can’t have a safe and effective immunotherapy yet.

Go home and die!

You can read the FDA’s response here >> fda-response-to-citizens-petition.pdf

Here are some of our thoughts on the FDA response. We welcome your comments.

Before addressing the specific requests in your petition, we first want to make it clear that we share your concern for men suffering from advanced prostate cancer.

Too many men continue dying a painful death while the FDA continues to stonewall the approval of Provenge by not addressing the deception that took place during the Provenge approval process.

We are committed to expeditiously reviewing the new information as soon as it is submitted.

This was the only good thing we read in their response.

PLEASE HURRY.

THIS IS AN EMERGENCY!

FDA shares the goal of approving new products, such as Provenge, as soon as they are shown to be safe and effective.

Provenge has shown all along that it is safe and effective. The Advisory Committee questions are regulatory questions.

Is it safe?

Is there substantial evidence of efficacy?

The panel voted overwhelmingly that it is safe and effective.

The FDA response tried to gloss over the conspiracy and conflict-of-interest issues, simply denying them without offering any evidence.

The agency lied when it said Provenge didn’t slow progression in either 9901 or 9902A. The correct terminology would have been “did not slow progression with statistical significance.”

We think that 11.7 weeks vs. 10.0 weeks in the 9901 trial is evidence of slowed progression.

A p value of 0.052 (Journal of Clinical Oncology number) or 0.085 (FDA number) should not be taken lightly, even if it did barely miss statistical significance.

Combine that with the survival p value of 0.01, and that’s pretty convincing evidence that 9901 was a successful trial.

It is a lie that Provenge did not slow progression in 9901, and it is a lie that there is no positive correlation between progression (91.5-94.8%) and survival (99.0%). The FDA’s progression argument is a LIE.

FDA has a long history of permitting access to investigational drugs to treat serious and immediately life-threatening diseases without adequate available therapies. Individuals can obtain access by enrolling in on-going clinical investigations of such products, including any existing expanded access protocols.

Continue Reading FDA LIES & DENIES — CARE TO LIVE CRIES »

Popularity: 17%

Dr. Pazdur says he has no documents and those he did have he previously destroyed….BOTH his hard copies and electronic copies of communications with Scher/Hussain reportedly destroyed

Freedom of Information reveals Dr. Pazdur searched both his paper and computer files and could not locate any documents responsive to plaintiff’s request.

From FDA, affidavit from Dr. Pazdur also enclosed:
See id. at ¶ 6. Dr. Pazdur recalls receiving both hard
copies and electronic copies of the letters from Drs. Hussain and Scher in April 2007. See id. at  ¶ 7. However, as these letters related to a specific regulatory application conducted by a  different FDA Center (CBER), did not fall under his direct regulatory supervision, and did not  require a response from him, Dr. Pazdur shredded the hard copies of these letters and deleted any  electronic copies. See id. The documents were shredded and deleted within a month of receipt.  See id. In fact, Dr. Pazdur does not keep personal copies of any regulatory communications.  See id. at ¶ 8. Official copies of regulatory correspondence are kept in the official regulatory  document room of the specific center assigned to an application. Id.  Contrary to plaintiff’s suspicions, Dr. Pazdur never disclosed Dr. Scher’s or Dr.  Hussain’s letters to “any individuals outside of the FDA, or any media outlet, including a  publication called ‘The Cancer Letter.’” See id. at ¶ 9. In addition, he did not write any portion  of the letters that Drs. Scher, Hussain, or Fleming sent to the FDA. See id. at ¶ 10. He also never received a copy of a letter from Dr. Thomas Fleming to the FDA regarding Provenge. See id. at ¶ 11.

5/18/2009 Freedom of Information Act (FOIA) documents received

Declaration of Richard Pazdur >> ctlpoaz29exbd-5.pdf

Defendant FDA’s Motion for Summary Judgment >> ctlsj29-1a.pdf

Declaration of Fredrick J. Sadler >> exba.pdf

Declaration of Nancy B. Sager >> ctlexhibitc3.pdf

Declaration of Beth Brockner-Ryan >> ctlryanexhibitb.pdf

* * * * *

8/7/07 Motion for Order to Preserve Evidence

Popularity: 20%

Seems there is no moving forward without moving backwards, as much as moving forward would be the right thing for everyone to do. The FDA won’t allow us to move forward so we must forever walk them through the sins of the past. The FDA dooms themselves to forever be walked through events of the past, events of the present, and events of the future.

While they have the power to end it happily like good old Ebenezer, and to help Tiny Tim (Teddy), they choose to let it end without redemption for themselves. Ebenezer Scrooge epitomizes the current FDA.

http://www.youtube.com/watch?v=qY2TT_aj_Fw&feature=fvsr

First, today, we visit the Provenge of May’s gone past.

As you know shortly after the FDA announced that they were not going to approve Provenge in May 2007 advocates met with then commissioner Andrew von Eschenbach to discuss the mistake the FDA had made in denying the BLA for Provenge and not allowing late stage prostate cancer patients to have Provenge.

It appeared that absent from the group of advocates at that meeting was anyone from the Prostate Cancer Foundation. However, unbeknownst to the advocates there meeting with Dr. von Eschenbach, the Prostate Cancer Foundation was in fact there. The problem was they were there on the other side.

The Prostate Cancer Foundation had and has the ear of former commissioner Andrew von Eschenbach. It is now crystal clear that if they would have gone they would have been sitting on von Eschenbach’s side of the table. Since the Commissioner has left the FDA, CareToLive has requested his help and he has declined (that request was renewed after the data came in).

The advocates at the advocacy meeting might not have seen it in Andy’s eyes but in them were, Michael Milken, Jonathan Simons and Stuart Holden all from the PCF.

They had and have the ear of Dr. von Eschenbach. What good could it do for the advocates to meet with Andy von Eschenbach when the largest prostate cancer patient advocacy group was absent and was in fact telling von Eshenbach to do the opposite that the advocates at the meeting were advocating for? Did those advocates know that they were speaking to the commissioner and the PCF? It’s kind of like the old poker adage; if you are sitting at a poker table and you don’t know who the sucker is, it’s you. The chair that spoke loudest was the chair that sat empty. When is the PCF going to pull up its chair to the right side of the table?

Thy enemy has shown thyself and that enemy is within the advocacy groups themselves. In deference to Michael’s love for baseball: Does anyone doubt that if the PCF would just step up to the plate and call for accelerated approval they could hit a home run.

In September of 2007 on behalf of CareToLive I sent a letter to Michael Milken by regular U.S. mail seeking his support for the effort to make Provenge available to late stage prostate cancer patients. That letter was never responded to.

Aren’t Mr. Milken and his groups in favor of speedier approval and access to treatments for late stage disease when the patients are without good alternatives?

Michael Milken founded the group Faster Cures which has shown no indication that it is in fact willing to support getting treatments such as Provenge to the patients faster.

Mike Milken says:

FasterCures

This Washington, D.C.-based think tank is removing barriers to progress against all life-threatening diseases.

The FasterCures team is dedicated to saving lives by saving time.
Milken Institute

Mike and his Faster Cures both remain MIA!!

More importantly, the greatest scientific achievement in late stage prostate cancer treatment in modern history and the PCF does nothing to help groups like CareToLive and others to try and speed it to the patients. If not now when? They have no right to call themselves prostate cancer patient advocates. Since the new data was announced CareToLive again sought the assistance of the multimillion dollar funded Prostate Cancer Foundation. These requests have repeatedly been made by CareToLive and they have repeatedly been ignored by the largest, most powerful and influential prostate cancer advocacy group first made in 2007 and then later made by request at the April 24th 2009 PCF round table in Washington D.C. and then later made by e-mails and finally culminating in the open letter sent by e-mail and regular U.S. mail to PCF CEO Jonathan Simons.

Soon after the advocates meeting with Dr. von Eschenbach after the Provenge denial in 2007 came this event:

Los Angeles, 2007 Milken Institute Global Conference
Building a Food and Drug Administration for the 21st Century

Moderator:
Greg Simon, President, FasterCures/The Center for Accelerating Medical Solutions

Panelists:
David Gratzer, Senior Fellow, Center for Medical Progress, Manhattan Institute
Andrew von Eschenbach, Commissioner, U.S. Food and Drug Administration

Greg Simon, President of FasterCures/The Center for Accelerating Medical Solutions and panel moderator began by asking how we can take the FDA we have today and get to the one we need for the 21st century. Andrew von Eschenbach, Commissioner of the FDA said, “in essence, the FDA is an information management business, and the world around us is changing fast and the data is changing also.” Personalized medicine will fundamentally change how the FDA approaches its work and how it is organized and the types of skill sets employees need. Dr. von Eschenbach talked about how science has crossed the threshold where diseases can be viewed through a molecular prism. “This doesn’t have to be about the science of safety or efficacy, with new molecular medicine we can have both,” he pointed out.

Balancing patient safety with access will be critical. “We have these discussions and a lot of time is spent on safety but we need to be sure we have an innovative drug market,” offered David Gratzer, Senior Fellow at the Manhattan Institute. Moving towards a “lifecycle approach” at the FDA that balances safety and access is critical and was a key message of the 2006 Institute of Medicine study on drug safety.

Beth Seidenberg, Partner at Kleiner Perkins Caufield & Byers pointed out that the future is now. Programs at the FDA like the Critical Path Initiative need even more support and resources. “We need to give the FDA the tools, people, and money to ensure the agency can take advantage of these scientific advances.” A system of integrated medical information based on electronic health records and data sharing will allow for more streamlined post-marketing surveillance and will get the FDA away from paper to electronic files. Resources and systems change are needed to advance these IT systems at the agency. “We need to get around the proprietary relationship to data and see that having access to large population data sets is the only way to advance.”

When Greg Simon asked each panelist to name the most important next step for the agency two themes emerged: getting the agency more resources and the creation of a creative strategic plan that embraces the possibility of how personalized medicine can change how we currently approve drugs.

Andy also says:
http://www.mikemilken.com/videos.taf?video=6&type=wmp

Mr. Milken and the PCF: Today there are an estimated 10 million cancer survivors just in America alone — men and women who in many cases have life expectancies measured in months, not years. “Many would gladly enlist as foot soldiers in an effort to help cure a disease that in many cases will be genetically passed on to their children and grandchildren.”

* “Cancer researchers, clinicians, and patient advocates rarely speak with one voice on any subject related to the disease. They fight over funding priorities; they squabble over treatment options; they joust over the relevance of biological discoveries. But virtually everyone agrees that Milken deserves an enormous share of the credit for the progress made against this major killer. ‘Mike’s done more for prostate cancer research than anyone in America,’ says one of the nation’s best-known prostate surgeons, Patrick Walsh, head of urology at Johns Hopkins.”
* ” ‘Michael Milken changed the culture of [medical] research,’ says Andrew von Eschenbach, director of the National Cancer Institute. ‘He created a sense of urgency that focused on results and shortened the timeline. It took a business mindset to shake things up. What he’s done is now the model.’”

* ” ‘Michael is always thinking creatively,’ says [Dr. Leroy] Hood, sounding like a convert. ‘He transformed how you do research in the field of prostate cancer and how you think about aggressively going after a disease. It has been a real revolution.’ ”

Mr. Milken, Mr. Simons we want to speak with one voice, why won’t you return our call?

Why won’t you respond to our e-mails?

Why won’t you help us to help late stage cancer patients now?

Where is the disagreement with regards to Provenge and WHY won’t you help?

So you backed the wrong horse but there is still time to change your bets, still time to turn the cart upright, still time to wipe that egg off your face and move forward.

HELP!!!!!

Here is what the PCF as a group says:

Although there has been dramatic progress in finding better treatments, the impending increase in incidence makes the need greater than ever. Fortunately, recent advances in science have made the opportunities greater than ever as well. With your support, we will be able to pursue more of these opportunities and hasten the day when prostate cancer is merely a sad memory.

Hey PCF, why won’t you give us a straight answer on our call for helping Provenge get to the patients sooner?

It’s bad enough that you have been MIA these past 2 years but now you simply have no excuse.

Teddy needs Provenge now!

Ebenezer Scrooge said of Tiny Tim, “If he is going to die he should do it and decrease the surplus population”.

I hate to be so grim on a Sunday but I have no patience for the FDA’s lack of humanity and no tolerance for the PCF’s non-support of quicker approval of Provenge because they are afraid if they do that it may bruise their ego.

Even Scher and Coffey at the PCF round table said they would rally behind Provenge if the data was there on April 28th…where is the rally?

Really, where is the rally?

Lets go!

No more free pass.

Popularity: 27%

Howard C. and John Fish were the two late stage prostate cancer patients who gave Care To Live Attorney Kerry Donahue, standing to file our lawsuit against the FDA in Federal Court in Ohio, two years ago. Had Howard and John been able to receive Provenge when it should have been approved, they might still be with us today.

“Attached hereto as “Exhibit E”, is the signed letter by Howard CXXXXX who is an AIPC patient in Ohio who seeks Provenge now. Howard is very ill and in late stage of prostate cancer. He hopes that if he can’t get Provenge in time to help him that he can at least help others to receive it. John Fish (letter attached to Plt mot. for inj, exhibit H), also from Ohio is a late stage cancer patient who wants Provenge now.”

Our dysfunctional FDA coupled with a corrupt cast of characters, needs to be overhauled and made to serve the public by bringing better, safer, more humane treatments, like Provenge, on the market without years of delay.

The system is so flawed that after we filed more than a dozen motions fighting to have the corrupt decision addressed, the FDA, defended by the Department of Justice, paid for with our tax dollars, received a ruling by the Federal Court saying that since the decision is not final, as the Provenge application is still pending, the case is not ripe to be heard.

Tell Howard C. and John Fish and Stephen Study, and the Wicks, and the 60,000 other men who have gone on to die from prostate cancer during this unjust approval delay, that the decision by the FDA was not final.

With the unambiguous and robust survival results that were just shown in the THIRD confirmatory phase 3 trial, the FDA needs to immediately make Provenge available to the thousands of the men who would be eligible to be treated with the Provenge immunotherapy, in order to empower them  to fight for their lives.

Every man should have the same chance Eduardo Garcia had. He had given up on life when his daughter enrolled him in the Provenge trials 8 years ago, and after 3 treatments in a doctors office, he crawled out of bed and is alive and well.

Howard provided a great service to mankind by stepping forward to say that men with prostate cancer matter. All the Care To Live Members and Supporters hearts and prayers go out to Howard and his family.

Grow a heart FDA. You have delayed this long enough. There is no excuse to keep men waiting another year while you follow your draconian protocol. There can be no doubt that it works. Now let’s get it to the men today!

Answer our CareToLive Citizens’ Petition that has been languishing in your office for almost 2 years and Approve Provenge NOW!

Read and Leave Comments on our FDA CareToLive Citizens’ Petition Request to Reconsider the Failure to Approve Provenge >>

http://www.regulations.gov/search/search_results.jsp?css=0&N=0&Ntk=All&Ntx=mode+matchall&Ne=2+8+11+8053+8054+8098+8074+8066+8084+8055&Ntt=FDA-2007-P-0168-0011%20%20&sid=121682D41130

We need everybody and be the voice that Howard no longer has, and to contact the FDA, Congress, and the Press in the link below.

Operation Accelerate Approval >>http://caretolive.com/2009-04-28/operation-accelerate-approval-update/

Popularity: 30%

Today, the data was released at the American Urological Association conference, and it once again points to why the FDA needs to get the Immunotherapy Provenge to the men with late stage prostate cancer as quickly as possible!

The Provenge Impact trial showed a 38% 3-year survival rate!!

A 22.5% reduction in the risk of death!!

GREAT JOB TO ALL THE FOLKS AT DENDREON.

THIS IS GOING TO CHANGE THE WAY CANCER IS TREATED!

MUCH THANKS TO OUR ATTORNEY KERRY DONAHUE & DAVID MILLER OF BSR RESEARCH FOR BELIEVING IN THE SCIENCE, AND TED GIRGUS AND ALL THE MEN WITH PROSTATE CANCER AND THE HUNDREDS OF CARE TO LIVE MEMBERS AND SUPPORTERS.

We are asking everyone to call or write the FDA and tell them to get this to the men ASAP.

FDA Contact Information
Dr. Jesse Goodman
His division of the FDA, CBER, handled Dendreon’s BLA for Provenge
E-mail: jesse.goodman@fda.hhs.gov
Phone: 301-827-0372

Acting FDA Commissioner
E-mail: commissioner@fda.gov
Phone: 301-796-5000

Paul Richards
FDA Public Affairs - He is handling the CTL Citizens Petition
E-mail: paul.richards@fda.hhs.gov
Phone: 1-800-835-4709 or 301-827-2000

Other FDA Public Affairs people paid with our tax dollars to serve the American people:

Phone: 1-800-835-4709 or 301-827-2000

Patricia Harley
patricia.harley@fda.hhs.gov

Lanessa Hill
lanessa.hill@fda.hhs.gov

Stephen Ripley
stephen.ripley@fda.hhs.gov

Here is an overview of the data reported today, April 28, 2009:

PROVENGE extended median survival by 4.1 months compared to placebo (25.8 months versus 21.7 months)

Biotech Analyst, David Miller, told Mike Huckman at CNBC if it is over 4, it would be a home run!

PROVENGE improved 3-year survival by 38% compared to placebo (31.7% versus 23.0%)

The IMPACT study achieved a p-value of 0.032, successfully exceeding the pre-specified level of statistical significance defined by thestudy’s design (p-value less than 0.043), and PROVENGE reduced the risk of death by 22.5% compared to placebo (HR=0.775);

PROVENGE exhibited a favorable safety profile consistent with prior trials.

Provenge is safe and it shows a survival benefit.

We already knew this 2 years ago when the FDA Advisory Committee voted it 17-0 safe and 13 to 4 substantial evidence of efficacy.

We need to get this to the men now!

Here is the Dendreon News Report>>http://investor.dendreon.com/ReleaseDetail.cfm?ReleaseID=380042&Header=NewsIt shows a 38% 3-year survival rate….22.5% reduction in risk of death! Contact your politicians and tell them to get it made available now.

Care To Live Presents Operation Accelerate Approval

Read and Leave Comments on our FDA CareToLive Citizens’ Petition Request to Reconsider the Failure to Approve Provenge >>

http://www.regulations.gov/search/search_results.jsp?css=0&N=0&Ntk=All&Ntx=mode+matchall&Ne=2+8+11+8053+8054+8098+8074+8066+8084+8055&Ntt=FDA-2007-P-0168-0011%20%20&sid=121682D41130

http://www.youtube.com/watch?v=wbggEGUaE28

Get ready to spread the word. We are not done. We don’t want to wait a year while Provenge winds its way through the approval process.

TED GIRGUS NEEDS PROVENGE YESTERDAY!

Mitchell Gold: “met its pre specified end points” “confirms results of previous studies” “data met criteria and specifications of Biologics License Application” “results were robust” “results were unambiguous and held up to multiple sensitivity analysis” “a clear hit on statistical significance”.

It is the first active immunotherapy to show a survival benefit in a phase 3 study. It is a tremendous accomplishment for the company and it means a tremendous amount for prostate cancer patients across the world”. ”

“We showed a survival benefit, which is the gold standard outcome of oncology clinical trials,  in a large randomized phase 3 trial.”

To Contact your Elected Officials 

http://www.conservativeusa.org/mega-cong.htm

From DeepCapture.com

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Overstock CEO Patrick Byrne just wrote an incredible story covering part of the Dendreon Debacle. Thanks Patrick. You are the best!

Read it here  >> Dendreon’s Cancer Researchers vs. Hedge Funds & The Bootlick Journalists (or, What’s 18 Million Fails Among Friends?)

Popularity: 31%

Phase One

Today, Thursday April 23, 2009 at 11:15 a.m. at the National Press Club in Washington DC, CareToLive board member Mike Kearney along with Frank Burroughs of the Abigail Alliance will be asking important questions and monitoring a meeting of some important players from the prostate cancer advocacy community.

Important media will be monitoring this meeting. Mike and Frank are wired for sound by award winning documentary film maker Hilary Birmingham. The documentary producer will also be there getting video of the event and has already interviewed both Mike and Frank this morning.

The meeting information is at the bottom of this blog.

Goal: To speed Provenge to approval and more importantly availability for the patients from an advocacy perspective, following the announcement of success by Dendreon regarding the IMPACT trial.

After careful consideration we have determined that the goal remains to create a groundswell of support by all means available in order to create pressure on all parts of our government to stop acting as bureaucrats stuck to the seat of their chairs and to compel them to take the humane action of super accelerating Provenge approval on behalf of all the late stage prostate cancer patients who so badly need it.

The FDA had one chance to approve Provenge in May of 2007.

They had a 2nd chance in October when Dendreon and the IDMC gave them interim data.

They have a 3rd chance now.

There is no reason this process of approval should take until 2010. Approval can be accomplished by the FDA by making special consideration for a treatment that has already been proven safe and effective for a late stage disease as previously voted by an FDA expert panel and which is designated for a serious class of late stage prostate cancer patients. The patients waiting for Provenge lack good alternatives and they need our help to get Provenge now.

The FDA has the means to take a much more humane approach then they have previously taken, whether it’s by granting the CareToLive Citizen Petition or merely recognizing that this is a special case that merits urgent review at the highest levels of the FDA.

This ground swell can happen, but we can’t do it alone.  Pressure needs to come from many sources inside and outside of Washington. If all prostate cancer advocates can come together for this effort then the call will be heard loud and clear throughout Washington and those poised to help can spring to action. The advocacy groups, particularly the large advocacy groups need to step up and advocate for the patients right to have Provenge now.

Late stage prostate cancer patients need Provenge now. If these prostate cancer advocacy groups don’t stand up now (or at least on April 28th when the full data is released by Dendreon) and join the call for immediate approval of Provenge then what are they waiting for and who are they working for? This is the biggest breakthrough for prostate cancer patients in recent history. We ask that the advocates speak up and speak loudly!

We have many friends/supporters of our cause in high places inside and outside the government. They are ready to help but we must turn up the volume on the call for super accelerated approval so as to help them to make it happen.

This is the meeting today. I will update the day’s events soon.

MEDIA ALERT for Thursday, April 23, 2009

WHAT:
Discovery & Challenge: The State of Prostate Cancer Research

A Roundtable Discussion with Leading U.S. Experts

Hosted by the Prostate Cancer Foundation, this roundtable discussion will feature commentary from eight U.S. experts in the field of prostate cancer research and treatment.  The program will focus on the following areas:

• The current prevalence of prostate cancer
• Reaching beyond the PSA screening debate
• Promising scientific breakthroughs
• Challenges ahead for research and discovery
• Funding for continued research
• Models for furthering progress

WHERE:
The National Press Club - First Amendment Lounge
529 14th Street NW, Washington D.C.
and via telephone access
Call-in number: 800/550.7798 (U.S. & Canada) 213/233.3044 (International)
Conference ID:  3154713
Attendees accessing the discussion via phone will be able to e-mail questions during the Q&A period: dzenka@pcf.org.

WHEN:    Thursday, April 23
11:00 am - Registration
11:15 am - Program begins and phone line opens
12:30 pm - Program concludes

WHO:
Josh Wolfe, Moderator
Co-founder, Managing Partner of Lux Capital
Editor of the Forbes Wolfe Emerging Tech Report
Alvin Chin, Prostate Cancer Survivor & Advocate, Virginia Prostate Coalition
Donald S. Coffey, PhD, Professor of Urology, Oncology, and Pharmacology and Molecular Sciences, Johns Hopkins University School of Medicine
Captain Melissa Kaime, MD, Director, Department of Defense, CDMRP
Peter S. Nelson, MD,
Professor of Medicine and Oncology
Fred Hutchinson Cancer Research Center and the University of Washington
Howard Scher, MD, Chief of the Genitourinary Oncology
Memorial Sloan-Kettering Cancer Center
Padmanee Sharma, MD, PhD, Researcher
University of Texas M. D. Anderson Cancer Research Center
Jonathan W. Simons, MD
President, CEO and David Koch Chair, Prostate Cancer Foundation
David E. Wheadon, MD
Senior Vice President of Scientific & Regulatory Affairs, PhRMA
S. Ward Casscells - MD, Assistant Secretary of Defense for Health Affairs U.S. Department of Defense.

Popularity: 51%