Dear CMS,

Please consider first and foremost the men and the families who love them. These are the true beneficiaries of the Provenge Medicare coverage. To you they may be portrayed as points on a graph, but to us, each and every one of these men, matter greatly. We call them Dad, Grandpa, Son, Brother and Husband.

During the approval and now coverage process, we have experienced moments of extreme joy and devastating heartbreak. The almost five year old continuing Provenge saga, ongoing since Dendreon first filed the clinical portion of their Biologics License Application with the FDA in 2006, has ended up on your doorstep to make a coverage determination by June 30. So many of our men’s hopes and health are now riding on you.

We at Care To Live would like to make clear to CMS, FDA, NCI and all the other government agencies peripherally involved, that this process that Provenge and other treatments go through is much too long and much too arduous for the patients awaiting treatment. Serious consideration must be given to find ways to get these exciting new treatments to the patients who are without viable alternatives to death, sooner, including passage of the Abigail Alliance sponsored Access Act.

The FDA in particular, needs to help bring treatments for late stage disease, like late stage prostate cancer, to the patients earlier. During the Provenge approval process, the FDA and the NCI sadly acted as patient adversaries and barriers, instead of the bridge that we were promised.

Within CMS’ own walls, mistakes were made. We hope you will strive to avoid these careless actions in the future. Never should safety and efficacy, already put through a long and laborious FDA review process, ever be evaluated by your agency. If you decide to evaluate a treatment based upon your stated intentions, such as uniformity of coverage and classification of reimbursement, then you must make it very clear at the outset that this is your intention.

CMS lacks authority to re-evaluate data provided by the FDA for a treatment’s safety and efficacy. Such action is particularly ill conceived when it is a treatment for late stage cancer. Without fast action by Dendreon, patient advocates, and several Congressmen, many more men may have been denied treatment. Total catastrophe was averted but not before your agency came close to creating chaos as seen through the eyes of many patients, some of whom urged Congress to get involved.

This should never be allowed to happen again.

Despite what some have said in these comments and elsewhere, making late stage prostate cancer patients out to be sick old men, that is just plain wrong. Most are still active, vital people, with no outward signs of disease. Some are still quite young, and all, if left untreated, will die too early of a very painful disease.

We are not about to let that happen. Care To Live Continue Reading Care To Live Submits Moment of Silence to CMS »

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Care To Live is very concerned that too many men are again unable to access Provenge. The FDA continues to take its own sweet time inspecting Dendreon’s clean rooms in order that Dendreon be able to provide Provenge to more men now. The FDA fails to recognize the importance of rearranging its priorities, along with the need for taking things out of order sometimes.

In cases such as Provenge, whereby we have an unmet demand for a treatment for late stage cancer where there are no viable alternatives, the old “first in first out”, is not reasonable nor acceptable. Humanity compels this bureaucracy to look at the bigger picture, men’s lives, and to act non-bureaucratically.

Care To Live Inquired of CBER on August 26, 2010

XXXXXXXX

Please feel free to correct us if we are wrong but we understand that Dendreon’s New Jersey Plant is waiting on FDA approval before it can begin using the additional 75% plant capacity.

We understand that you are an extremely busy agency. However, it seems that there are some things that should be given at least some priority over others.

In this case Dendreon is way short of being able to satisfy the demand/need for Provenge. That combined with the fact that Provenge is for a late stage patient population makes timely certification of this plant all the more important.

We would request that CBER make all possible effort to timely certify the plant so as to enable more prostate cancer patients to benefit from this new treatment as soon as possible.

Thank you for the consideration.

Care To Live

________________________________________________

Response on September 1, 2010

Thank you for your recent inquiry to the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) regarding Provenge. CBER, one of seven centers within FDA, is responsible for the regulation of biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products.

While we can not discuss specific details with you regarding the Dendreon plant, we appreciate your concerns regarding the availability of Provenge and take them very seriously.  The Agency recognizes the importance of new cellular therapies like Provenge, for serious diseases for which current treatment is unsatisfactory. We will continue to work closely with the manufacturer in its efforts to make Provenge available to the public.
Sincerely,
H.A.
Consumer Safety Officer
Consumer Affairs Branch
Division of Communication and Consumer Affairs
Center for Biologics Evaluation and Research
US Food and Drug Administration

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
__________________________________________

On October 15, 2010

XXXXXXX

The FDA has its new Fast TRACK program but there is no info there about sipuleucel-T (Provenge). Isn’t this supposed to show where the FDA is with regards to inspections?

We can’t figure out why inspection of the additional 75% of capacity of the NJ plant can’t be timely completed. This is a treatment for which demand far exceeds supply and it is for late stage prostate cancer patients.

The FDA’s Fast TRACK program is supposed to provide additional accountability and transparency on the process. Everyone should be entitled to know where the process stands at the FDA regarding this extremely important inspection. Importantly, can’t the process be given some priority considering the circumstances??

Care To Live

______________________

On October 19, 2010

Thank you for your recent inquiry to the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) regarding Provenge. CBER, one of seven centers within FDA, is responsible for the regulation of biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products.

While we can not discuss specific details with you regarding the Dendreon plant, we appreciate your concerns regarding the availability of Provenge and take them very seriously.  The Agency recognizes the importance of new cellular therapies like Provenge, for serious diseases for which current treatment is unsatisfactory. We will continue to work closely with the manufacturer in its efforts to make Provenge available to the public.

If you have further questions regarding the availability of Provenge, you may contact the manufacturer, Dendreon Corp., directly at www.dendreon.com or 877-336-3736 regarding their product.

We hope this information is helpful.

Sincerely,
H.A.
Consumer Safety Officer
Consumer Affairs Branch
Division of Communication and Consumer Affairs
Center for Biologics Evaluation and Research
US Food and Drug Administration

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As Care To Live anxiously waits for the FDA to approve Provenge any minute now, media coverage has picked up. More and more people are learning about this exciting prostate cancer treatment about to revolutionize the way cancer is treated.

It started on Sunday with the Seattle Times running a front page story.

http://seattletimes.nwsource.com/html/localnews/2011695773_dendreon25m.html

This article features a picture and story about retired Boeing manager Bob Feutz, and his wife Fran. Bob participated in a Provenge clinical trial in 2007 and shows no signs of relapse. That’s three years and still going strong.

Yesterday CBS’s The Early Show, ABC’s Good Morning America Show and CBS Evening News, all spread the news. Local affiliates also did reports yesterday.

On The Early Show, Harry Smith spoke to Dr. Jennifer Ashton. Dr. Ashton pointed out that Provenge does not have the toxicity of chemo and radiation and that the exciting thing about this vaccine is that many cancer experts look at it as the future in cancer treatment.

On Good Morning America, George Stephanopoulos interviewed Dr. Richard Besser. Dr. Besser said the hope is for other cancers, to use your own immune system to fight cancer. When Mr. Stephanopoulos asked about the price, Dr. Besser said it would run about $50K to $75K per course but additional studies hope to increase effectiveness and decrease the cost.

On CBS Evening News, Dr. Jon Lapook did the report on Provenge for Katie Couric. The footage contained a clip from the big protest Care To Live and others held outside the FDA Headquarters in Rockville, Maryland.

The Mean Vs. The Median

This science lingo has always confused people into thinking that Provenge only prolongs life 4.1 months. Nothing could be further from the truth.

Dr. Lapook interviewed Dr. Philip Kantoff of Dana-Farber Cancer Institute who said, Provenge works and it prolongs survival. When Dr. Lapook finished his report Katie asked him about the cost. She said considering there is only a little over four month survival, is the vaccine really worth it? Dr. Lapook reminded her Provenge was tested on the sickest patients first.

Luke Timmerman recently did a very good article about the pricing of Provenge. Jan Manarite from the Prostate Cancer Research Institute posted a good comment in regards to price:

PRICE - Keep in mind that Provenge will be a series of 3 pheresis treatments, given over about one month. Done. Most oncology treatments go on for months. Some indefinitely. That one unique variable will make the price of Provenge – in the big picture – end up costing less than many other oncology drugs.

You can read Luke’s article here: Continue Reading PROVENGE MAKING THE ROUNDS »

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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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November 23, 2009

SENT BY FACSIMILE AND U.S. MAIL

Citizen Petition -2007-P-168

Karen Midthun, MD
Acting Director of CBER
Food and Drug Administration
1401 Rockville Pike
200N
Rockville, MD 20852

Dear Karen Midthun, MD ,

I am representing and speaking for an advocacy group by the name of CareToLive. The group CareToLive filed a Citizen Petition with the CBER division of the FDA on July 26, 2007. That Petition asked for a reconsideration of the May 2007 denial of a license for distribution of Provenge, made by Dendreon Corporation. Provenge is a treatment for late stage prostate cancer, which is a patient class without appealing treatment options.

While your office denied that petition in early 2009 you did indicate that when your office did obtain the remaining data requested from Dendreon (the results of the IMPACT trial), that, as stated several times in your Petition response, CBER would expeditiously review that data.

The last line of the CBER response said:
“We look forward to receiving Dendreon’s amendment to its existing BLA so that we may review this information expeditiously.”

While we were disappointed that CBER did not end the IMPACT trial based on the interim data provided by the Independent Data Monitoring Company (IDMC) that CBER was presented with in mid 2008, as that was clearly additional confirmation that Provenge was safe and effective, so that the patients who are in great need could have started receiving Provenge much sooner, we remain hopeful of expeditious review now that the trial was completed and you have all the data.

Now, 2 ½ years after the original AC panel of experts voted to approve Provenge you have been provided a response by Dendreon to your then issued CR letter. You now have all the new data requested as of October 30, 2009 which was the day Dendreon completed its rolling aBLA submission.

We are writing you this letter to remind you of the promises made in your response to the CareToLive Citizen Petition to review the data expeditiously. Please devote whatever resources you can to this evaluation so that it can be timely completed. Remember that this is no ordinary application; rather it is an application for approval of a treatment for end stage prostate cancer for which viable treatment options do not exist.

We at CareToLive get e-mails and letters from patients and their families every week who desperately want Provenge for themselves or their loved ones. Some of the stories we hear are heartbreaking. Having Provenge approved by Christmas of 2009 would provide much hope and joy to these patients and their families at a time of year when joy is needed. Recently we lost one of our advocates, Bruce Tower to late stage prostate cancer. Mr. Tower got a placebo in the IMPACT trial. We understand that at the beginning not everyone that wants Provenge will be able to get it, but we have to start somewhere. Approval by Christmas would be an act worthy of much praise and many advocates including CareToLive will praise such effort as we understand you would need to work diligently for such an extraordinary and very humane effort to occur.

If you think the timetable for approval of Provenge by Christmas is impossible, then please explain why it is impossible so that we can try to understand. While I know you are extremely busy folks there, this is a treatment for which the original BLA was filed (and voted to be approved by experts soon thereafter) in November 2006.

If expeditious review is something that you no longer think your division is capable of, then we would like to meet with you to discuss it. We will come to Rockville for such a meeting (or anywhere else you like). We would like the meeting to be held one or two weeks after Christmas, if you are available. We would like to bring several board members from CareToLive as well as about 5 other prostate cancer advocates including Thomas Farrington (PHEN).

If approval can be completed expeditiously there is probably little reason for the post Christmas meeting to occur. If that approval is impossible within that time and you do not estimate approval in the days or week thereafter then these advocates would very much like to meet with you so as to discuss the issues involved with the inability to move expeditiously as promised in your Citizen Petition response, on the amended BLA for Provenge.

Thank you very much for your time and consideration of this matter.

Sincerely,

Kerry Donahue

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When looking at The Freedom of Information Act [5 USCS § 552], notice what it states in Section 3:

B) Each agency shall make reasonable efforts to maintain its records in forms or formats that are reproducible for purposes of this section.

C) In responding under this paragraph to a request for records, an agency shall make reasonable efforts to search for the records in electronic  form or format, except when such efforts would significantly interfere with the operation of the agency’s automated information system.

(D) For purposes of this paragraph, the term “search” means to review, manually or by automated means, agency records for the purpose of locating those records which are responsive to a request.

The FDA responded to this by saying such a search for documents sent to and from Richard Pazdur would be complex. Then the FDA mistakenly told the court that such a request would be too costly, not realizing the requester pays for it.  After the search was completed, Richard Pazdur simply declared that he deleted and shredded the documents two years ago and CareToLive had to pay 40 cents for this complex search! 40 cents!

You can’t even purchase one of these for 40 cents!

Sadly, the Court in the Southern District of Ohio ruled in favor of FDA.

CareToLive’s fine attorney, Kerry M. Donahue, filed an appeal this past August and last night he filed our Appellate brief (Appellant’s brief) which is our written argument for the 6th Circuit Court of Appeals which they will review and then probably set up for oral argument.

The FDA (Appellee) has 15 days to file their response, but we would not be surprised if they get an extra 2 weeks after that if they need it.

You can read the brief here>>   ctlappealfoia11172009pdf.pdf

Here are some highlights:

“The Appelle has consistently argued that the Provenge matter is still an “ongoing process” so the destruction of documents regarding an ongoing process demands further inquiry.“

“Either way the FDA did not perform the “complex” search that it promised the Court and Appellant that it was conducting.”

“The search time incurred by the FDA CDER division FOIA office was so slight that it did not even register on the radar as a significant reportable/billable search time. That was the entire “complexity” of the search and response.”

“…the FDA told inquiring members of Congress that they did in fact conduct an internal investigation.”

” It does not cost the Defendant anything!“

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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: 11%

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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