Dear Colleague (ahem),

Now for the cover letter that accompanied that spurious paper.

These anonymous dolts are truly grasping at straws, alluding to fictional dreams of bloodshed and birth defects.

We are not about harming people. Au contraire. We want people to live longer with better quality of life.

If I were to mention Thalidomide, which caused birth defects in thousands of women, in the same sentence as the safe, non toxic, non invasive immunotherapy Provenge that helps men with prostate cancer add years to their lives, I would want to remain anonymous too.

Who are these physicians and scientists in favor of suffering and death?

Okay, okay, I will shut up and present the letter.

anonymous-misinformation-cover-letter.pdf

Our previous blog covered the bogus report making the rounds, falsely disparaging Provenge. (see blog below Provenge is Approved but the Lies Continue)

This further dispels that bogus report. Care To Live has learned,

Dendritic/other immune cells are extravascular, not in the blood. Removing less than 3% of immune system. If you check 3 weeks after apheresis, level of immune cells in blood is same as prior to apheresis.

The immune cell count calculation within the report appears to be wrong. Based on the article, the calculation discussed the immunodepletion of the cells within the blood. However, the majority of immune cells are in the TISSUE, and not just in the blood. Dendreon measured the immunodepletion 3 weeks into the trial and that was normalized.

Within the clinical trials no increase in infection was seen between placebo arm and Provenge arm. This suggests a normalized immune system.

The survival in the control arm was no different than historical normals for Prostate Cancer.

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A bogus 27 page paper is being aggressively sent around wall street, and the medical, scientific regulatory and legal community, asking people to contact the FDA and the CMS. The cover letter touts the nonsense that they are scared to voice their concerns publicly. Feigning their safety fears is the same ploy they used last time, hiring bodyguards, at the taxpayers expense, fabricating non-existent threats, while no police reports ever turned up. This time we are determined to get to the bottom of it.

provenge-approval-fud.pdf

Their poor argument about the Phase III trial is dispelled here by Provenge advocate Ocyan:

This was a serious piece of work to support an argument that Dr. Hussain put up during the 2007 AC meeting when she said that the placebo protocol might have been active and could hurt patients. At that time, she gave no explanation of how that could be the case. Now, the argument is that it is immuno-depletion.

The basic idea is that a large number of immune cells were taken from a patient in a leukapheresis procedure. If a patient was on the treatment arm, he would get most of them back on reinfusion. However, if a patient was on the control arm, he only got back less than a third of what was taken during the leukapheresis procedure. Therefore, the immune system of a placebo patient was suppressed. That is called immuno-depletion.

The immuno-depletion attack on Provenge goes like this. Because of immuno-depletion, Continue Reading Provenge Is Approved But The Lies Continue »

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Senseless years of death and delay for late stage prostate cancer patients while FDA Honchos collect huge salaries, enjoying life to the fullest.

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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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   On January 28, 2010 the Florida Bar recognized Kerry M. Donahue, CareToLive’s attorney extraordinaire, for his stellar pro bono efforts on behalf of prostate cancer patients.

“The Food and Drug Administration has lost its way”, said Mr. Donahue. “The FDA Advisory Committee advised the FDA to approve Provenge, a safe, effective, non-toxic immunotherapy for men with late stage prostate cancer, and then the FDA delayed it without a rational explanation.”

Kerry sprung into action. He wrote dozens of motions and briefs, spending hundreds of hours trying to right the wrong. Without his efforts, we at CareToLive believe that the FDA would have deferred to the chemo cartel, who never wanted Provenge to see the light of day. He brought enough exposure, to insure that Provenge gets a fair chance for licensure this time around.

The FDA knew the patients were staring death in the face since they granted Dendreon’s Provenge Fast Track Status and Priority Review. It then chose to ignore its handpicked Advisory Committee which voted Provenge safe by a vote of 17-0 and substantial evidence of efficacy, by a vote of 13-4.

Kerry was honored by the President of the Florida Bar, Jesse H. Diner, & the Chief Justice of the Supreme Court of Florida, Peggy A. Quince.

Recently the Acting Director of CBER, Karen Midthun, denied Kerry’s request for a meeting. Ms. Midthun said the reason was as follows: “However, FDA cannot discuss matters with respect to a pending BLA without the express authorization of the sponsor. Therefore, at this time, we respectfully decline your request for a meeting.”

This statement flies in the face of the fact that FDA leaked letters written by Howard Scher, Maha Hussain, and Thomas Fleming all of which were discussing “matters with respect to a pending BLA” which were released “without the express authorization of the sponsor.” FDA picks and chooses when it will violate its own regulations, in order to help its business and political relationships.

At the center of this case is Howard Scher, a SGE for FDA, who was leading trials for treatments in competition with Provenge at the time he sat on the Provenge Advisory Committee. One day later he started working on a letter with the help of NCI’s Alison Martin for the sole purpose of lobbying the FDA to stop Provenge. Scher knew the Advisory Committee vote was a problem for his competing trials, one of which NCI funded, so he sprang into action right away. CTL has documented Mr. Scher’s activities and financial concerns (see Sleepless in Asentar and CTL Writes Interim FDA Commissioner Frank Torti). The astonishing fact is FDA went along and helped Scher by leaking his letter as well as follow-up letters by Hussain and Fleming, all of which discussed matters with respect to a pending BLA.

The FDA then had its legal team block all efforts by Kerry to get the men access to Provenge. Over 80,000 men have died while we waited another 2.5 years for further results. Those results are now in and they confirmed that Provenge is safe and effective. We are still waiting while they drool over the data.

In the meantime Kerry is also fighting for the Freedom of Information data to prove how flawed the process was. They are stymying us again, at every turn. He is determined to bring more oversight and transparency to an agency that has run amuck.

Congratuations to Kerry for receiving the Florida Bar President’s Pro Bono Service Award for 2010. CTL and all the friends of CTL are very proud of you. You are the best that mankind has to offer.

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In Memoriam: August 24, 2009
Remembering Bruce Tower

On September 17th, 2007, I arrived at JJ Muldoon’s Pub in Gaithersburg Maryland around 9 PM. Before too long, I heard the thunderous voice of a distinguished looking gentleman. He was being escorted to a mini-van by a woman whom I found out was one of our heroines, Melody Davis. Many around them were making a fuss. As the word spread the atmosphere became electrifying. It’s when we all realized who this man was.

Bruce, suffering from late stage prostate cancer, was not in the best physical condition, but he nonetheless made the trip to Maryland to help us protest the next day outside the FDA Headquarters in Rockville. His gut-wrenching speech captured the audience and delivered the message. Many men, like him, need Provenge NOW. They could be strengthening their immune system, fighting the awful disease we know as prostate cancer.

On a Sunday afternoon in April 2008, I spoke to Bruce on the phone. We chatted a bit and then we discussed our fight for Provenge. It was almost a year now and he was willing to keep fighting right along with us. He gave us permission to use his picture and he wrote a letter which we published as an ad in the Rockville Gazette. It is a sad statement to say we had to pay a lot of money to get the story in the local newspaper in the hometown of the FDA. Several times he appeared on the Andrew Schorr Patient Power radio show with us. He and his wife Carol were there whenever we needed their help.

(click to enlarge)

Week 2 Ad Color caretoliverockvillegazette2ad.pdf

http://caretolive.com/2008-04-09/caretolive-continues-its-in-your-face-ad-campaign-asking-the-fda-to-approve-provenge-for-prostate-cancer-now/

In his letter, Bruce made a simple plea. “Here is my plea; FDA: Please approve Provenge NOW.”

He could have had it working in his body for over two years. Now he will never get the chance to try Provenge to fight for his life.

I can hardly type this now because I just learned we lost Bruce Tower. The emotions run strong. Sadness for Bruce’s family. Anger for the FDA playing the wrong kind of god and withholding a safe and effective treatment. From everything I learned about Bruce, he was a remarkable man, dedicated to his wife, children and grandchildren. He inspired and taught other kids as a soccer coach. He led by example. He was a fine citizen indeed.

From everything I learned about our modern day government, these self-serving fools in charge could basically not give a damn. They are out of touch. They lost control. They are driving a long train full of people to their death tricking them into thinking they are going over a bridge. I can tell you with certainty, there is no bridge.

The empty promises of Andrew von Eschenbach and the nerve of him, makes my blood run cold with contempt. To me, he is the epitome of the captured FDA as declared by Harry Markopolis. To me, he let his friendship with convicted felon Michael Milken ruin his objective mission to serve the American people. Von Eschenbach double-dipped with the FDA and NCI leadership. He already set the Conflict of Interest stage. How could he keep an eye on it when he was wallowing in it?

Poor Bruce and his family. They should have had better. Their goverment let them down. They paid their taxes for nothing, not to mention the pain Bruce endured in his final days. I heard Bruce handled it like the champion he is. He only wanted to see those around him smile and live the good life.

May God richly reward you, Bruce. You should hear those words of old, “Well done my good and faithful servant.” May God comfort your family. May you rest in peace.

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What made me sickest over the Larry King show on prostate cancer was in the beginning of the show, when Larry King stated something along the lines that if they find the cure for prostate cancer they just might have to name it or call it the Milken cure. That set the tone for the show and the angle he was playing.

Larry King lost most of his fortune not too many years ago flipping insurance policy’s under the advice of some scammers. It worked well until he found out he was the mark. To recover, it looks like he went with Madoff, where he was once again taken to the cleaners. In Milken he finally found someone with juice. The show was packed with the mutual admiration society. Milken is doing his image rehabilitation desperately seeking a pardon. Maybe Larry will have Kerry on next (I can dream).

Larry King, Mike Milken, John McEnroe, Colin Powell, Joe Torre, Rudolph Guiliani, a cast of big mouths with not one word to say about Provenge. They are a sickening, pathetic bunch. We know Larry knows about Provenge because many of our friends and members reached out to Larry in the past and more recently before the show. Now if I were a conspiracy theorist…

They never mentioned Provenge, a non toxic, non invasive safe and effective immunotherapy that harnesses and enhances your own healthy cells to fight your own prostate cancer cells. Some men with late stage pc are living 8 years later. 1 in 6 men will get prostate cancer in their lifetime.

Provenge should be on the market by next year, in spite of Milken. His chairman, Howard Scher of the Prostate Cancer Foundation Therapeutic Consortium, and Milken’s recently departed CEO, Alison Martin of the Melanoma Research Alliance, colluded on the leaked letters that stopped Provenge dead in its tracks from reaching the 69,000+ men who have died since May 2007.

Mark Mitchell of Deep Capture recently published an exposé about Milken’s part in the death of 60,000 men and the delay of Provenge. The complete story of Dendreon is now available  21 August 2009
Read the full story

The PCF is also trying to take credit for financing Provenge? It stated this because it sent some money to the University of San Francisco back in the year 2000 for Eric Small to work on immunotherapy. In 2006 Small wrote a rather positive article stating Provenge may work. In 2007 Howie Scher and Alison Martin used that 2006 abstract against Provenge highlighting the word “may” as to say it may not work. PCF cannot take credit here. It can take credit for two of its big shots stopping Provenge which had positive Phase III trials under its belt while Asentar, Abiraterone and GVAX, treatments the PCF touted, were only finished with Phase II trials.

Furthermore, in the 2005 PCF Annual Report, Novacea and Cougar did not give any money to PCF. Dendreon donated between $25k to $50K. Cell Genesis gave between $10K to $25K.

Not only did the PCF do nothing to push for Provenge approval, they actually accepted money from Dendreon to support the PCF. It should have been the other way around. Dendreon was struggling for every dollar it could muster, and must have felt it had to make a donation to PCF too! Something stinks in the world of Milken’s philanthropy and I can smell it all the way in New Jersey.

Continue Reading Hey Larry King! Do your homework!! »

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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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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

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

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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

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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.

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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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