March 11, 2010

Dr. Sharfstein,

Can you please check with CBER and see why it is taking them so long to make a final decision on Dendreon’s Provenge.

The pending BLA is an amended BLA that was first submitted to the FDA in 2006. Following a March 2007 AC, in which the FDA hand picked experts overwhelmingly voted for approval, CBER decided to require additional proof of efficacy. That additional proof, as set forth in the SPA, was in fact obtained by Dendreon with results being announced in April 2009 (interim data was also positive and the IDMC also recommended approval in October 2008).

Now CBER has had all the new clinical data from the IMPACT trial as of July 2009 and all the CMC data since October 2009. Despite promises from CBER to the advocacy group CareToLive and others that they would review this treatment, intended for late stage prostate cancer, expeditiously, the treatment inexplicably remains unavailable.

This review is hardly being done expeditiously. FDA has now delayed this treatment from reaching patients for 3 years.

Please inquire/help.

Kerry M. Donahue, Esq.

Counsel for CareToLive

Dublin, Ohio

CTL Petition for reconsideration of May 2007 decision to issue CR filed in July 2007.

Popularity: 22%

This letter was delivered by Fed Ex to our Attorney, Kerry Donahue, today, 01-11-10, at around 1 PM.

Download the letter here >>  cberletterofresponsetocaretolive.pdf

(Click on to enlarge)

Popularity: 20%

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!

Popularity: 17%

Dendreon will submit their new Provenge Biologics License Application by the middle of November. The FDA has 6 months to respond. Let’s hope the FDA, after having delayed Provenge for over 2 1/2 years without cause, will move to approve Provenge quickly as they promised us in response to our Citizen’s Petition. They told us repeatedly that if the data is there, they will expediate approval. Come on FDA. over 74,000 men have died waiting and many more lives hang in the balance.

Take the Provenge Virtual Manufacturing Tour.
http://activation.dendreon.com/virtual-manufacturing-tour

Popularity: 17%

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: 21%

HISTORY WAS MADE TODAY!

A non toxic, non invasive Immunotherapy to strengthen the body’s ability to fight prostate cancer achieved its goal of being  supportive of the previous trials, as required by the FDA.

Mitchell Gold, Dendreon CEO, held a conference call to announce the results of the Provenge Impact Trial.

Here are some of Dr. Gold’s words concering the results: “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 was great news for long suffering prostate cancer patients who are one step closer to gaining access to Provenge.

It was great news for people around the world seeking better, more humane treatments to fight cancer. Dendreon has a pipeline of immunotherapies on the back burner.

Here at Care To Live we are ecstatic. However our work is very far from over. We need the FDA to allow the men access to Provenge NOW!

We are already getting emails from people begging for access. The FDA needs to heed their cries, and speed the approval process through. These men have already been waiting for 2 years while the FDA dawdled. They don’t have the luxury of wasting more time.

Mike Kearney had written to Andrew Schorr of Patient Power, to keep him updated. Mr. Schorr did a breaking news interview with Dr. Sam Chang, a Urologist from Vanderbilt University to find out what he thought about Dendreon’s announcement today.

At the end of the interview, Andrew said “Doctor, you sound really excited about this.” The doctor said, “Yes, not only for prostate cancer but for other cancers as well.”

Recommended listening: http://www.patientpower.info/Audio/ht/HT041409.mp3a

http://www.patientpower.info/

Our thanks go out to the entire DENDREON team in Seattle, Washington and Hanover, New Jersey for their hard work and unending dedication, and to all the Care To Live members and supporters along with Attorney Kerry Donahue for making this day possible.

Special thanks to our devoted webmaster Matt Jurmann of ChromaticSites.com

We urge the FDA to move swiftly.

Popularity: 23%

 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)

* * * * *

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.

* * * * *

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

* * * * *

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

* * * * *

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
* * * * *

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

* * * * *

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

Popularity: 34%

Tonight Ted Girgus to discuss Prostate Cancer and Provenge on Andrew Schorr’s Patient Power 9 PM EDT, 6 PM PDT

http://www.patientpower.info/webcastdetails.asp?dateid=
12/10/2008&webcastid=SCCA121008

If you have any questions you would like answered please
Email questions to: questions@patientpower.info

and help spread the word

Video of Ted Girgus who has late stage prostate cancer and is desperately waiting for the past several years for Provenge approval.

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

12/10/2008

6:00 - 7:00 pm PST

9PM EDT
Navigating Dilemmas Posed by Prostate Cancer Treatment Options
Live from (6:00 - 7:00 pm PST) Pacific. Check back for a link to the live program.

Treatment for localized prostate cancer carries with it not only issues of cancer control, but significant impact on health related quality of life. Measurement of cancer control and HRQOL outcomes is yet to be fully explored by the medical community. In this webcast, join Dr. Bruce Dalkin as we focus on how to measure cancer control in an optimal fashion and .

Guests:
Bruce Dalkin, M.D., Urologic Oncologist, Seattle Cancer Care Alliance
Ted Girgus, Prostate Cancer Patient
Peter Frishauf, Founder of Medscape

How to participate

Email questions to: questions@patientpower.info

Popularity: 25%

ctldecision.pdf

The court ruled,

“Appeal Denied”.

Kerry is very sorry we could not win this for the patients suffering with AIPC. “We will take the fight to the Supreme Court but we understand that this is not timely enough for many thousands of suffering men.”

We are unripe. We are in FDA limbo. We haven’t been denied a license, yet you can’t get Provenge, but it is not denied, just delayed a few years. To our fathers, husbands, sons and brothers who have passed away, it is as final as anything can get. The FDA needs to be disbanded and the patients rights given back to the patients and not the corporations, and “venture capitalists.”

Unconscionable!

We fight on!

Next Stop

Kerry Donahue, our lawyer extraordinaire, has incredible fortitude to pursue this fight on behalf of men with late stage prostate cancer. The Courts are passing this hot potato up the hill. Kerry has filed a lawsuit on behalf of CareToLive to try to get men with late stage prostate cancer access to Provenge, a safe, non toxic, non invasive immunotherapy. Somebody needs to get the ear of the right fat cats on the hill, exchange a few suitcases of cash, no, wait a minute, that would be illegal. We have men we love who need Provenge NOW! Approve it because it is the right thing for a civilized society to do. Visions of Soylent Green come to mind.

FEAR NOT!

MOTION TO THE SUPREME COURT TO REVIEW Coming Soon!

Kerry, We LOVE You. You are doing an incredible job. You stand among America’s finest. Your amazing work on behalf of men with late stage prostate cancer is unrivaled!

http://caretolive.com/lawsuit-news/

The courts are part of the system, pushing us aside, shutting off another route to redress. We will stay in their face. What choice do we have.

Ted needs Provenge NOW!

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

http://www.youtube.com/watch?v=UqAx7uZAS90

THE CAN CAN
http://www.jibjab.com/starring_you/receipt/2111682

Popularity: 22%

http://www.pharmalot.com/2008/07/civil-servant-disobedience-a-critical-fda-site/

Excerpt

Civil Servant Disobedience: A Critical FDA Site
11 Comments
By Ed Silverman // July 18th, 2008 // 12:55 pm
A new web site called Thoreau-FDA.com has emerged that is highly critical of the agency and, in particular, FDA commish Andy von Eschenbach, who is accused of oppressing FDA employees and preventing them from doing their jobs. The site, which is anonmyously crafted, is allegedly the brainchild of an unknown number of current and former agency employees.
Their goal: “to intensify public scrutiny of FDA upper management’s efforts at ensuring public health protection in an increasingly complex global marketplace…and engage (Andy), his successors and FDA upper managers in a public question and answer dialog … to end the entrenched process flaws in FDA’s pre-approval drug review and post-approval regulatory enforcement systems.

* * * * *

http://www.thoreau-fda.com/letter.php

Customize this letter and tell Commissioner “Andy” (as he likes to be called) Von Eschenbach what you really think about the delay for over a year of the immunotherapy Provenge for the 30,000 American men who die of prostate cancer every year without any options(not to mention the rest of the men in the world)

GoTo Blog #5 Click here
Part 5 — Naked Shorts — $75,000 For Cracking the Wall Street Cover-up REDUX
http://www.nowpublic.com/world/part-5-naked-shorts-75-000-cracking-wall-street-cover-redux

Popularity: 18%