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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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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 The Wick Family has 4 men with prostate cancer. Too late. Make that 3. Brad’s Uncle died this week. If Provenge were approved 2 years ago, as it should have been, he might still be with us today. With his permission, here is what Brad wrote.

My uncle

I would like to ask for your thoughts and prayers for my family - my favorite uncle died yesterday due to cancer.  It was a catch 22 for him, his platelet count was too low due to the chemo killing them off, but his only treatment for his Stage 4 cancer was chemo.  He had prostate cancer, but cancer had spread to other areas - his lungs, liver, and back.  He has had chemo treatments over the past several months and would have good and bad times.  But with his platelet count low, they wouldn’t give him chemo and he went downhill much faster than any of us expected.  He tried to get into clinical trials but none were accepting patients or there were none available in the area.

It pains me to no end that potential life saving treatments are on the horizon, but are often shot down due to self preservation, greed, and cost/red tape to get the product to market.  I miss him and my mom is just torn up.  I hope and pray that treatments like Provenge can be out there to help give patients a fighting chance.  I know that it won’t save every patient, but to me 20%+ is better than 0%……and patients can live a life with dignity and pride and not put up with the horrible side effects that I have seen ravish my uncle (lost hair, weakness, poor sleeping, etc).  When will the FDA start wearing the “patient only” glasses without the outside distrations?

Thanks for letting me vent.  This has been a tough time.

May God bless those fighting for what is right and for those stricken with this horrible disease.  You are the true heroes!

Brad Wick

(click on pictures to enlarge)

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Words cannot express how sorry those of us at Care To Live feel. We are doubly sad, because Care To Live member Brad Wick, has done so much to help us in our battle to get Provenge approved. He has been there with us every step of the way.

When we did our Rockville, Maryland newspaper campaign, (in the FDA’s backyard),  his Dad and Mom allowed us to use them in an ad. What a great picture of them and Brad’s children, (and niece too). Our thoughts and prayers go out to the Wick family.  It is people like Brad, the best in the world, that make it clear we must double our efforts. We must get Provenge made available NOW!

One in 6 men get prostate cancer. 30,000 of them go on to die from it every year. Dendreon’s Provenge is a non toxic, non invasive immunotherapy, that is administered in a few treatments in the doctors office, using the patients own white blood cells. These fighter cells are retrained to attack and destroy the cancer, like they did when you were healthy.

Eduardo Garcia, was in the Provenge trials over 7 years ago. Until that time, he had crawled back into bed waiting to die, too weak to do anything, a common effect of late stage prostate cancer. After he had his three infusions, he became so strong and healthy that he went back to work.

Provenge went before the FDA for approval over 2 years ago. A panel of experts was convened, who voted it 17-0 safe, and 13-4 substantial evidence of efficacy. Two “doctors”, namely Howard I Scher, and Maha Hussain, from the chemotherapy industry put on the panel by Richard Pazdur aka “the cancer czar”, both had severe conflicts of interest, and had to sign waivers although they conveniently left out many of their conflicts. They were both very vocal at the panel, that they needed more proof. Provenge has already been through over 10 years of Phase I, II and III testing.

The “doctors” lobbied the FDA to delay approval. Letters were leaked to the same inside non peer reviewed source that published the imclone erbitux non approval, sending Sam Waksal, CEO of Imclone, and Martha Stewart to jail. We believe that Richard Pazdur of the FDA was the “leaker”. Richard Pazdur of the Chemotherapy, Radiation side of the FDA, ran roughshod over the approval process, (passing notes to one of the conflicted doctors etc), even though Provenge is a biologic agent and did not reside in his division. Imclone’s Erbitux was subsequently approved for colon cancer, unfortunately not in time to help those who died waiting. A congressional hearing was called over Imclone.

We had several Congressmen call for a hearing over the Provenge debacle,  but John Dingell of Michigan refused to hold it. His wife is tied to the cancer industry. Congressman John Dingell (Michigan) and Frank Pallone (New Jersey) decided against a Congressional hearing for all the wrong reasons. You can read their response to those calling for hearings. 2/13/08
micha001.pdf
Three Congressmen, Mike Michaud (D) of Maine, Dan Burton (R) of Indiana, and Tim Ryan (D) of Ohio called for a congressional hearing into the conflicts of interest and what went wrong at the FDA causing the delay of Provenge. (click this link) Read the Congressional Letter calling for a Hearing 12/13/07.

Besides, Congress is too busy holding hearings on steroid usage in baseball players, which nobody has died from. Who cares about 30,000 sick old American men. In reality, men are dying from prostate cancer in their 30’s and 40’s as well.

The really sick people are those running the FDA. They oversee a corrupt, dysfunctional bureacracy, with little care for the lives and health of the citizens of the United States. They are more concerned with power and lining their own pocketbooks.

Billions of dollars paid out to pharmaceutical companies, hospitals, stock holders, and Wall Street titans, will be lost, if the entrenched Oncology treatments are replaced by immunotherapies. This is an uphill battle, but one we need to fight, for all of our sakes.

Dendreon has immunotherapies for breast cancer, colon cancer, etc, on the back burner, due to the delay in Provenge approval, causing a depletion of their research and trial money. This is the way wall street plays the game and influences the FDA decisions. Delay and destroy. If not for Care To Live Provenge would have been long gone, possibly even being bought out by a larger company, whose goal would be to throw it in the trash heap, to ensure nothing interfere with their profits from the current toxic, debilitating treatments and the billions spent managing their horrible side effects.

The common protocols when you are diagnosed with prostate cancer is usually either removing your prostate gland, or some type of radiotherapy such as implanting radioactive seeds in your scrotum, which kill the cancer cells. Unfortunately they kill they healthy parts of your immune system too, and radiate your vital organs. You may also opt for watchful waiting now called active surveillance. Most men are encouraged to be treated. If your cancer progresses, they will give you hormone therapy, which is really female hormones, to try to supress your testosterone. All men who go on hormone therapy, will eventually fail, unless they go on to die from something else.

Provenge has show survival in 20% of the sickest men, those in late stage, who have already had either their prostate gland removed, or been radiated, and also had hormone therapy which is no longer working. These are men whose cancer has already metastacized to their bones and organs. Imagine what it might do, were it given to men earlier in their diagnosis.  Once an immunotherapy is approved, it will be a paradigm shift in the way cancer is treated.

Michael Milken, runs the world’s largest prostate cancer charity in the world. He has been silent during this entire fiasco. The Provenge interim results of another Phase III trial were recently released, showing 20% survival. Not a word from him or his Prostate Cancer Foundation. It is apalling but not surprising. Milken, is a convicted felon who sent time in jail for stock manipulation, and has investments in Provenge competitors. His “faster cures” nonsense, rings hollow with us. He helped fund the Proquest Investment fund. He is busy shaking his can everywhere, asking for more funding to begin research 10 years away from approval, but has nothing to say about Provenge, which is ready, willing and able to be used RIGHT NOW! It is an abomination.

Proquest Investment News Release Link
Nov-01-1998 Start-Up 1 The Opportunity in Cancer: Goldberg’s Variation Prostate cancer will be the focus of ProQuest Investments LP, a new venture fund founded by Jeremy Goldberg. With investors the Ann and Robert H. Lurie Foundation of Chicago, Alza Corp., and high net worth individuals, including Michael Milken, ProQuest has raised $40.5 million in its first closing.

May-01-2000 Start-Up Proquest Investments LP Proquest Investments is a $100 million oncology-focused investment fund, partnered by Jeremy Goldberg and Jay Moorin. The firm aims to leverage its specialization and focus to create a brand that will make it the preferred VC firm for Internet, device, biotech and pharmaceutical companies with products that advance the treatment and cure of cancer, its founders hope.

Former FDA Commissioner Andy Von Eschenbach, was repeatedly asked to reconsider the Provenge decision. He refused. He did go on to lobby President Bush for Mike Milken’s pardon. Just recently he took a job at Greenleaf Health llc.“ This is from the press release. As I look forward to new opportunities to transform healthcare, I am pleased to contribute to Greenleaf’s efforts on behalf of the public health,” Dr. von Eschenbach said. “Working with Greenleaf’s clients to help them bring life-saving therapies to the patients and doctors who need them is one gratifying way for me to provide input on crucial health policy issues.” Read the press release here >> http://greenleafhealthllc.com/PressRelease_VonEschenbach.html

Over 54,000 American men died of prostate cancer while Von Eschenbach was Commissioner. None of them were allowed to use Provenge to fight for their lives. Where is the outrage?

Here is a picture of Milken, Pazdur, and Von Eschenbach.

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Madoff Whistleblower Markopolos at the Congressional Hearing on the 50 billion dollar ponzi scheme.

Congressman Alan Grayson: Are you familiar with the concept of capture when you are talking about regulation? What is that? Do you know that concept?

Harry Markopolos: Yes. It’s basically when the regulator is in bed with the industry they purport to regulate and do not regulate the industry. In fact, they consider the industry the client, not the public citizens.

Congressman Alan Grayson: And have you seen that in action.

Harry Markopolos: Yes. At the Food and Drug Administration and at the SEC.

Excerpt starts at 14:14  http://www.cnbc.com/id/15840232?video=1021435842

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Where are most of the other prostate cancer advocacy groups. Provenge has been delayed for almost 2 years, for no damn good reason. Everybody needs to raise their voice. We need Provenge Now.

We thank Frank Burroughs and Steve Walker of the  Abigail Alliance, Scott Riccio of Accelerate Progress, Charles Reinwald of the Cancer Cure Coalition, and Attorney Kerry Donahue, Arnold Mass, Melody Davis, Mike Kearney, and many, many others of our loudest and staunchest advocates.

Please Join Us at CareToLive. http://www.CareToLive.com

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Video of Ted Girgus, making a plea for Provenge

 http://www.youtube.com/watch?v=6Q0uQAL_YDA

See more picture here http://caretolive.com/rally/

Here is a Video of the 2007 Rally at FDA headquarter  http://www.youtube.com/watch?v=UqAx7uZAS90
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We also tried suing the FDA for access, but the courts would not hear the case, as they said the decision is not final. Tell Brad Wick’s family that the decision was not final. There is so much more to this story. You can read more at CareToLive.

OBAMA CAN YOU HEAR US?

website

http://www.whitehouse.gov/

Congress your Representatives

Contact your Representatives and Senators and ask them to call for an investigation into the FDA’s handling of this travesty.

HOW TO FIND YOUR REPRESENTATIVE

Contact Your Elected Officials

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

by zipcode http://www.visi.com/juan/congress/index.html

If you go to the Congresspedia site http://www.Congresspedia.com and put your Representative’s name in the search box and scroll down and you will find all current contact information. Contact their Washington office as they have the most clout.

Call your Representative and ask for their Congressional Health Staffer.

Follow up with emails and faxes.

If you can visit their office.

Contacting the White House [En Español]

E-Mail Please send your comments to comments@whitehouse.gov

Vice President Joe Biden: vice_president@whitehouse.gov

PLEASE JOIN US!!!!   THIS IS AN EMERGENCY!

Permission is granted use all pictures and copy to help spread the word near and far.

http://www.CareToLive.com

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(written to the tune of Harry Chapin  - Cat’s in the Cradle   http://www.youtube.com/watch?v=zlHdjjHNEC8 )

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Harry Markopolos, at the Bernie Madoff Ponzi Scheme Congressional Investigation.

Congressman Alan Grayson: Are you familiar with the concept of capture when you are talking about regulation? What is that? Do you know that concept?

Harry Markopolos: Yes. It’s basically when the regulator is in bed with the industry they purport to regulate and do not regulate the industry. In fact, they consider the industry the client, not the public citizens.

Congressman Alan Grayson: And have you seen that in action.

Harry Markopolos: Yes. At the Food and Drug Administration and at the SEC.

Excerpt starts at 14:14  http://www.cnbc.com/id/15840232?video=1021435842

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The Citizen Petition filed with the FDA by CareToLive has now been pending for decision with the FDA for 556 days. The Petition which asked the FDA to reconsider its decision to deny a license to Provenge, was followed up by 200 positive comments in the months following that filing, by patients, families of patients, physicians, scientists, researchers and other fine citizens.

The petition process is the only formal way for patients and their advocates to ask the FDA to consider and address their wishes.

It has been 384 days since CBER head Jesse Goodman wrote to CareToLive and said that they needed some additional time to decide the petition.

It has been approximately 372 days since a CBER employee told CareToLive counsel that a committee had been formed and they were actively reviewing the petition.

It has been approximately 365 days since counsel for the CBER division of the FDA told counsel for CareToLive that they took the petition very seriously and that while she could not say who was on the committee considering the petition, she could make the assurance that they were in fact actively reviewing it.

God bless all the patients that watch and wait. Stay strong!

Kerry M. Donahue
6295 Emerald Parkway
Dublin, Ohio 43016

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