As the comments on the Centers for Medicare & Medicaid Services (CMS) website concerning the coverage of Provenge continue to mount, some people inadvertently, and some deliberately, have submitted inaccurate information. Care To Live (CTL), with the help of two of our exceptional physician and scientist friends, Dr. Robert Rostock and Ocyan respectively, continue to set the record straight.

It remains the opinion of CTL, based on all sources of information and investigation, that the CMS review is not about coverage or non coverage of Provenge. It is about interpreting the label, and how much to require from physicians prior to granting reimbursement approval.

We believe that the CMS review could and should actually lead to more patients being covered rather than less.

The argument should not be about coverage vs. non-coverage it should be about how early in the treatment regime patients will qualify for on label use.

We believe that CMS is wrong in not being more specific in their PR release, as to the specific purposes of review. They themselves are responsible for the circus-like atmosphere they have created. They should immediately issue a clarifying statement on this topic. Again, they have no legal or medical basis to deny coverage.

Dr. Robert Rostock, a first-rate prostate cancer Radiation Oncologist, who is in the trenches as he fights each day to treat men with late stage prostate cancer, provided his expert opinion.

“The label does need to be clarified. The sad truth is that most patients are diagnosed with a bone scan when there is already significant pain. Continue Reading Setting the Record Straight »

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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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The real story—the tragedy in this case, and the one yet to be told by the so-called “Mainstream Media”—is the story of the needless three-year delay in availability of Dendreon’s Provenge for our sons, fathers, and grandfathers.

The Dendreon Investor Village (IV) message board at www.investorvillage.com(link) is where a group of the most well-informed people in the world on all-things-Dendreon, exchange information. Many have posted there non-stop since early in the decade. One daily post entitled “Daily Death Count”, documents the number of men who have died of prostate cancer since “Black Wednesday” (link to Mark Thornton op ed), May 8, 2007, the date the FDA went against the recommendation of its own Advisory Committee and refused to approve Provenge. As of this past Thursday, the date Provenge received final approval, the death count stood at 90,055. Every one of these 90,055 men were deeply loved and now dearly missed by their families and friends.

It’s difficult to ignore the fact that the March 29, 2007 Provenge Advisory Committee voted unanimously (17-0) that the drug is SAFE, or the fact that the same Committee voted minutes later, (13-4) that the drug “demonstrated substantial evidence of efficacy,” the federally mandated standard in such reviews. But the FDA did. The FDA also ignored the fact that the treatment was being submitted to help men with end stage prostate cancer, the stage for which there is no viable treatment option. Provenge would have been their last resort. Continue Reading The Real Provenge Story »

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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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FDA returned on April 8th to check up on CTL.

Hey FDA, any word on Provenge approval yet, or are you still using snow days as an excuse to deny the treatment to the men who so desperately need it.

You are welcome to our site anytime. We look forward to seeing you in person at our next demonstration, but until then, make yourself at home here.

Oh, and we are still awaiting a response to our letter to Josh Sharfstein. Could you remind him to give us a call?

Thanks Brenda!

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Super ……… when Provenge is finally approved, after three years of senseless, needless delay by the FDA

Cali ……… where long time dendreon investors celebrate the advancement of science at the San Francisco Annual Shareholder Meeting

Fragilistic ……… the egos and the dynasty otherwise known as the FDA

Expeditious ali docious ……… Not expeditious in British

Even though the sound of it makes FDA sound quite atrocious!

Super-Cali-Fragil-Istic-Espi-Ali-Docious!

In loving memory of all those who participated in the Provenge trials and all those who could not receive Provenge for the past three years!

Citizens have a right to demand change from the FDA!

Before and after approval Care To Live will continue its goal of seeking a more patient oriented and citizen friendly humanity at the FDA.

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Dear FDA,

As you read this on your next visit here, why not just agree to meet with us in person.

Are you aware Ms. Midthun refused our request to meet with her?

Here is her reply:

 http://caretolive.com/2010-01-11/cber-responds-to-letter-from-caretolive/

If you are interested in how we feel and what we seek to accomplish, then PLEASE meet with us.

We are planning a demonstration at the FDA in front of your building as that is the only alternative left to get your attention. We are sure you will see that news here first….so until next time…..

We know you are watching us. What are you looking for? Better yet, what are you waiting for?

CareToLive set up this website in June 2007. It was an information site for people protesting the FDA’s poor decision to delay getting Provenge, a safe and effective, non-toxic immunotherapy for men with late stage prostate cancer. These men are dying in excruciating pain and have no other viable treatment option.

Provenge met the criteria for approval as it has proven survival, the gold standard for approval. A panel of FDA hand-picked experts voted Provenge safe, 17-0, and that it demonstrated substantial evidence of efficacy, 13-4.

CareToLive watched as people approached the last FDA Commissioner, Andrew Von Eschenbach, and asked him to reconsider the decision. They gave him some very good reasons. Mr. Von Eschenbach refused.  CareToLive incorporated, filed a Citizen’s Petition, and then a lawsuit, and challenged the FDA decision. CareToLive spelled out why Provenge was not given proper due process by the FDA when it processed the Biologic License Application (BLA).

In July 2007 the FDA visited this site. What was it looking for? It was very late at night, around 10:30. Who was at the FDA office and what were they looking for over here? Is that when they gathered to shred and delete documents in response to our lawsuit?

Here is a list for the past seven months when the FDA stopped by this website.

The FDA stopped by:
09/01/09
10/06/09 
10/23/09
10/28/09
11/23/09
12/04/09
12/28/09
12/29/09
12/30/09
01/03/10
01/19/10
01/20/10
01/21/10
02/25/10 
03/11/10
03/25/10

The NIH stopped by
12/02/09

Memorial Sloan-Kettering stopped by
12/04/09 
12/28/09 

Once again, what is the FDA looking for? More important, what is the FDA waiting for? If they read our blogs they saw the latest data presentation from Dendreon, the manufacturer of Provenge. It demonstrates the same safe profile and the survival advantage is better than anything available, by leaps and bounds. What are you waiting for FDA? Approve Provenge NOW!

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The honorable Pat Tiberi, House Representative from the 12th District of Ohio, refuses to accept a brush off by the FDA.

Representative Tiberi continues to doggedly pursue answers from the FDA as to why the ongoing delay of Provenge for late stage prostate cancer patients, continues without excuse.

Tiberii is a true Patriot, seeking answers for the men needlessly waiting on the dysfunctional FDA to do its job.

See his second recent inquiry to the FDA here (click below to enlarge) or download here pattiberi02.pdf

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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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