CareToLive is proud to announce that our counsel, Kerry M. Donahue, has been named the 2010 recipient of the Florida Out of State President’s Pro Bono Service Award. The award is presented annually by the Chief Justice of the Supreme Court of Florida to the attorney who best exemplifies the highest ideals of the profession in assuring the availability of legal services to those that cannot afford or are unable to obtain legal representation.As those who follow the work of CareToLive know, Kerry has worked long and hard hours since May of 2007 on a pro bono basis, in the uphill battle to obtain Provenge for late stage prostate cancer patients.Kerry will be receiving the award from the Chief Justice at an award ceremony on January 28 in Tallahassee, Florida.We at CareToLive thank Kerry for his dedicated effort on behalf of our cause and are pleased to see that he is receiving this well deserved recognition!

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Hold the deck.

It’s certainly okay to have the opinion that the FDA made a reasonable choice at the time it denied approval to Provenge in 2007. It’s not the right opinion, but it is a defendable one. It is not all right, based on what we now know, to say they made the right decision.

On the other hand:

That the Provenge BLA was not afforded proper due process is an absolute. Because it clearly was not afforded proper due process nobody can say with any certainty that the FDA made a reasonable decision. Once the process is corrupted it’s all guesswork from there. Nobody knows for sure the extent of influences and back room shenanigans that occurred to assure that Provenge was not fairly evaluated. When CareToLive through litigation and FOIA’s tried to get information they were stymied by the FDA who went to great lengths to avoid any transparency on the issue.

There are aces scattered all over the floor at the FDA and a couple sticking out of a few sleeves so how can the game have been fairly played? Is it too much to ask for a fair game? The denial of a fair PROCESS is the one truth that the FDA could have, should have, admitted.

If that process occurred in a court room there would, at a minimum, have been declared a mistrial, when the evidence of such became known (which was made known to the FDA by petition, litigation and of course lots of letters).

That they did not make a reasonable and common sense decision based on the class of patients for which Provenge was seeking approval, or conduct a proper risk/benefit analysis with a focus on the fact that the treatment was destined for late stage patients is clear.

The FDA said two things that support this; One was that the minority voices on the AC panel were taken into consideration as a factor in the decision making process, and Two is that Richard Pazdur of CDER influenced that process. Top that off with an FDA commissioner who just happens to be a very good friend of Milken……

I don’t want the point to be lost that it is the position of CareToLive that there is no way anyone can say a reasonable decision was made, because the process was completely corrupted. CareToLive has sought accountability and transparency to determine in what ways the process fell short. If the FDA would show us the process then we might be persuaded otherwise. Until then and even because of the cover up itself, it has to be evaluated based on what we know.

The cover up and the lack of transparency is indicative that the FDA made a choice that transparency would make matters worse in this case. Otherwise, why fight so hard to keep the process from the public eye.

What other influences entered into the picture. Political pressure? Milken pressure? Financial pressure? Inside power struggles? Some or all of the above?

The deck was stacked. The dice were loaded. Everybody knows!

With all that you now know about Milken and the depths of his depravity, does it not trouble you that he had considerable control and influence over at least Scher, Martin and von Eschenbach if not others? Continue Reading American Hold ‘Em »

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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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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/

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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

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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

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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 »

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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

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8/7/07 Motion for Order to Preserve Evidence

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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/

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On behalf of CareToLive I must share with you the news that the United States Supreme Court has denied Cert to our case, which means they have chosen not to review the matter.

Such a ruling does not mean that our arguments were without merit, it merely means the Court has determined that it is not important enough for them to spend their judicial resources on at this particular time.

It is possible we could be before the Supreme Court again in the future for several reasons:

1) None of the merits on the underlying claims made by CareToLive, including the fact that the FDA acted capriciously when they denied approval to Provenge on May 8, 2007 have been decided. Those claims will become ripe when a “final decision” is made on Provenge. The original case was dismissed without prejudice in the lower Court which means we can again file a new complaint.

2) We also currently have pending in the Southern District of Ohio the FOIA Complaint that the FDA received a stay on until May. In May the case will become active again and the Court has already ordered the FDA to produce documents.

Also remember that CareToLive still has a duly filed Citizen Petition pending at the FDA. While Jesse Goodman and Andrew von Eschenbach have chosen to ignore it to date, each new commissioner, whether interim or finally appointed, will have the opportunity to review the petition if and when it comes to their attention (if it has not already). There is new hope with each new commissioner.

Also, a friend of CaretoLive filed an appeal at HHS of the NCI decision to redact portions of the Scher e-mail received in an earlier FOIA request, which we await a decision on.

While we are upset about the loss, because the hope was to speed Provenge to the patients who so badly need it as soon as possible, we are far from being done with the ongoing fight.

While much work is done behind the scenes, please know that not a single day goes by where CareToLive members, supporters and its many friends are not taking action in some manner or another to try to speed Provenge to market so that the patients can benefit by it and the new era of immunotherapy treatments for cancer can be ushered in. This is done by continuing to spread the word among our citizens, lobbying important people in Washington within and outside of Congress, working to gain the interest of and assist media and documentary film makers as well as “educating” the FDA (new and old). The delay of Provenge has needlessly delayed the advance of science and shortened the life of many late stage cancer patients who passed without the hope that Provenge might have brought to them, but their memories live on and with us, as we continue to seek justice and reform at the FDA.

We also extend a very special thanks to those at the Abigail Alliance, Accelerate Progress, PHEN, Cancer Cure Coalition and other advocacy groups that are constantly working for the cause and share similar goals to ours.

We are not alone in this fight and continue to ask everyone reading this to continue to spread the word of Provenge. If a weekend arrives and you have not shared the story with someone during that week then write a letter, mail it and tell the story to someone else.

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