On July 28th, the Dendreon Corporation announced “the publication of data from the pivotal Phase 3 IMPACT study in the New England Journal of Medicine, showing that PROVENGE® sipuleucel-T) demonstrated a statistically significant improvement in overall survival compared to control in men with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer (mCRPC).  The manuscript is published in the July 29, 2010 issue of the journal.”

“These results represent the beginning of a new era in the treatment of cancer, one in which a patient’s own immune system is harnessed to fight the disease,” said Philip Kantoff, M.D., lead author of the publication, co-principal investigator of IMPACT and Chief of the Division of Solid Tumor Oncology at the Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. “Furthermore, the magnitude of the survival benefit coupled with the side effect profile and short duration of therapy place PROVENGE as a new standard of care for men with asymptomatic or minimally symptomatic mCRPC.”

The New England Journal of Medicine (NEJM) also included an editorial in which three questions were raised.

Below Care To Live presents the answers to those questions.(click this link)>> Continue Reading Provenge Works & Costs the Same as Chemo & Comments by Bishop »

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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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Friends, Patients, and Families,

Do not worry about CMS coverage of Provenge. Provenge will be covered by Medicare for the FDA-approved indication. Of this, you have our absolute guarantee!

The supply issue is the real problem. However, we are expecting 36 more hoods to come on line in the very near future. This will allow more men to get access to Provenge right away.

Our current understanding of the CMS concern, is the use of Provenge on the entire prostate cancer patient population versus the HRPC/AIPC patient population. The issue appears to have been taken up by CMS in order to provide uniform local coverage of on label use.

Provenge is not being reviewed on the issue of whether Provenge is to be covered. It is now, and will continue to be covered.

Furthermore, CMS is neither interested in negotiating or cutting the reimbursement amount to Dendreon, nor for any other reason contrary to the best interest of the company and the patients it is striving to serve, or reviewing the reimbursement of the cost to the attending physicians. 

The Provenge treatment is a new paradigm, and local Medicare offices do not know how to classify and otherwise handle the reimbursement issue. Thus the need for the review and clarification.

Care To Live will continue to carefully monitor, and strenuously object to, any attempt by our government to interfere in the doctor patient relationship. If the recently filed Freedom of Information request sheds light on any other modus operandi, it will be shared here.

Any attempt by the government to use Dendreon as a test case, at the expense of the little biotech that could, will not be tolerated.

Any attempt by the FDA to use CMS as a means to control the issue of off label use, is also being watched carefully.

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Today, CareToLive sent a FOIA request to:

Centers for Medicare & Medicaid Services
Office of Strategic Operations and Regulatory Affairs
Freedom of Information Group
Room N2-20-16
7500 Security Boulevard
Baltimore, Maryland 21244-1850

The request was sent via Express Mail and was also sent via their website,  http://www.cms.gov/foia/

Here is a copy of the request:    ctl-foia-request.pdf

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The Centers for Medicare and Medicaid Services (CMS) are currently seeking public comment as to whether coverage for Provenge should be provided to Medicare beneficiaries. CareToLive (CTL) asks all of its members and friends to file a public comment. CTL firmly believes coverage should be provided.

You can send your comment by simply clicking this link:    Public Comment

Here is my comment:

Commenter: Kearney, Mike
Title: Spokesperson for CareToLive
Organization: CareToLive, a not for profit corporation advocating for men with prostate cancer
Date: 07/02/2010

Comment:

I would like to respond to the questions Dr. Louis
Jacques, the director of the Coverage and Analysis
Group at the Medicare center, heard from people in
regards to Provenge. Dr. Jacques gave these
questions to Matthew Herper of Forbes Magazine.

“We’ve been getting questions from people,” says
Jacques. “‘Well, what’s up with Provenge? Is it a
drug? Is it a biologic? Is it something else? Does
it really work? It has been interesting to look at
the evidence around it.”

http://blogs.forbes.com/sciencebiz/2010/07/why-medicare-is-reviewing-provenge/?boxes=businesschannelsections

What’s up with Provenge is that it is medical
history. It is a paradigm shift for how we treat
cancer. No, it wouldn’t be considered a drug that
you would pop in your mouth, it is a biologic. In
fact, when it was approved by FDA, it was approved
by the staff of the Center for Biologics
Evaluation & Research (CBER). All the drugs are
approved by the staff of the Center for Drug
Evaluation & Research (CDER). Not sure what the
“Is it something else?” question is referring to.
But perhaps the best question, Dr. Jacques heard
is, “Does it really work?” Let’s look at the
evidence.

Three Phase 3 studies involving 737 patients were
Continue Reading The Centers for Medicare and Medicaid Services are requesting comments. »

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Dr. Myers’s thoughts on Provenge.
http://askdrmyers.wordpress.com/ (video)

About Dr. Snuffy Myers http://askdrmyers.wordpress.com/about/
With over 250 research papers published, Myers is one of the leading developers of today’s prostate cancer canon on both the research and treatment side of the test tube. Prostate Forum is the educational arm of his world-renowned practice that is dedicated to providing men with the comprehensive care that saved his own life.

Care To Live friend M.C. Lee summed it up.

- Longer survival
- Less side effect
- Comparable cost
- Productive life

M. C. Lee Edit: Forgot that demand will definitely outstrip supply in the FORESEEABLE future.  So if you want it you better bug your doctor about it.

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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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Patients, families and doctors can rejoice today as they FINALLY can get access to a safe treatment that will stimulate their immune system to fight prostate cancer. This also opens the door for more similar types of treatments in the war on cancer.

Congratulations to Dendreon for a steadfast mission that overcame more obstacles than Harrison Ford saw in the the movie, “The Fugitive”. Thanks to all CareToLive members and friends who fought for this great day in medical history. Thanks to our Attorney Kerry Donahue for his steadfast devotion to this cause.

LET THE CELEBRATING BEGIN!

DUBLIN, OHIO (CTL) - April 29, 2010 - Today, the Food and Drug Administration finally approved Provenge!!!

FDA NEWS RELEASE

For Immediate Release: April 29, 2010

FDA Approves a Cellular Immunotherapy for Men with Advanced Prostate Cancer

The U.S. Food and Drug Administration today approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm210174.htm

Note: Dendreon logo per www.Dendreon.com

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