With our deepest condolences we mourn the loss from prostate cancer, June 2, 2011 at 85 years of age, of one of Care To Live’s fiercest warriors during our battle for Provenge’s approval.  We never did, nor could we, thank him enough for all his help. Sometimes with death there is a revisiting of the person, and we welcome this opportunity to bring you Charles A. Reinwald the man, and his unique and incredible cancer foundation, with its focus on healing cancer, both medically and holistically.

A link to his website has always been right up there, on the top of our home page. Please add it to your ‘to do’ list. If you are a cancer patient, the Cancer Cure Coalition should be your first line of defense.

http://www.cancercurecoalition.org

Cancer Cure Coalition Mission Statement

http://www.cancercurecoalition.org/mission.html

Charles A Reinwald Biography

http://www.cancercurecoalition.org/board.html

Charles became a member of Care To Live early on. He was a great advocate of strengthening the immune system through diet and lifestyle changes, as well as medicine. Throughout the years Charles offered us advice, and support. He was fighting many wars, on many cancer fronts, but was never too tired to write one more letter or one more article, or to offer words of encouragement in our darkest hours, when we needed them most.

Charles was a rarity today. A true patient advocate, not beholden to any corporate or financial conflicts of interests.  He was not an investor in Dendreon which frustrated the likes of those reporters whose deviant agendas were to erroneously portray Provenge as ineffectual, such as Matthew Herper of Forbes Magazine.

A brilliant man, he strove to understand health and wellness better, utiliizing his vast talents to educate and share what he learned with others. That is what made him truly stand out from the pack.

Care to Live literally stood shoulder to shoulder with Charles at our Rockville, Maryland FDA protest on September 18, 2007. He was one of our keynote speakers.

Charles A. Reinwald lives on in the families who will receive Provenge, those patient advocate and those with cancer whose lives he touched directly, his wife, his children, several of whom attended our Provenge 10 city rally in Cleveland in 2008, his grandchildren, and through his wonderful Cancer Cure Coalition Foundation.

I strongly urge people to send donations to:

The Cancer Cure Coalition
305 Beach Road, Suite 204
Tequesta, FL 33469

Telephone: (561) 747-2127

a 501 (C) (3) tax exempt charitable organization. Your donations are tax deductible pursuant to the Internal Revenue Code.

* * * * *

In February 2008 Mr. Reinwald took the FDA to task in this press release.

http://www.reuters.com/article/2008/02/21/idUS136546+21-Feb-2008+PRN20080221

Cancer Cure Coalition Proposes Major Changes at the FDA

Thu Feb 21, 2008 7:45am EST

PALMS BEACH GARDENS, Fla., Feb. 21 /PRNewswire/ -- Flawed policies and bad

decisions at the FDA have contributed to an escalation of the cost of clinical

trials which now take an average of one billion dollars and require 10 years

for approval. This has delayed and even prevented the availability of many Continue Reading RIP Charles A. Reinwald — Cancer Cure Coalition Founder »

Popularity: 18%
				

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 »

Popularity: 28%

Human Health and Resources (HHS) transparency rules differs greatly between divisions. Center for Medicaid and Medicare (CMS) has been forthcoming with our Freedom of Information (FOIA) requests, while the Food and Drug Administration (FDA) and the National Cancer Institute (NCI) continue stalling. 

Read more at Pharmalot http://www.pharmalot.com/2011/04/the-fda-conflicts-of-interest-provenge-e-mails/

Popularity: 23%

Click Here >> to go to the CMS Comment Page

The April 29, 2011 Deadline is fast approaching. Take Nothing for granted.

Please take a moment to write a sentence or two to the Centers for Medicaid and Medicare (CMS) requesting them to continue providing coverage for Provenge, the FDA approved immunotherapy for late stage prostate cancer. It is a non toxic, non invasive FDA approved treatment, safer and more effective than anything that has been previously approved.

1 in 6 men get prostate cancer in their lifetimes. 30,000 a year go on to die from it. Provenge is the first approved treatment of its kind, which utilizes your own immune system to fight off the cancer.

In order to post, you must first open the CMS PHI Posting Policy link and then  remember to click the box below it:

Thank you for your prompt attention to this matter as this is time sensitive.

PS: If you have friends that will help, please email and forward. TIA

http://caretolive.com/Click Here >> on the CMS Comment Page to comment on the Autologous Cellular Immunotherapy Treatment of Metastatic Prostate Cancer (00422N).

Care To Live urges all of its friends and members to post a comment on the Centers for Medicare & Medicaid Services (CMS) web page encouraging them to support coverage of Dendreon’s Provenge.

Thank You,

Rory Kearney
President
Care To LIve,
a not for profit corporation

View Public Comments CAG-00422N  Comment Period: 03/30/2011-04/29/2011

http://www.cms.gov/medicare-coverage-database/details/nca-view-public-comments.aspx
?NCAId=247&ExpandComments=n&ver=11&NcaName=Autologous+Cellular+Immunotherapy+Treatment+of+
Metastatic+Prostate+Cancer&DocID=CAG-00422N&SearchType=
Advanced&bc=IAAAABAAEAAA&

Popularity: 21%

Care To Live has been notified by the Department of Justice (DOJ) that the final FOIA response from CMS is expected to be completed and released to CTL not later than April 15, 2011.

As soon as it is released, it will be posted here in its entirety.

Popularity: 14%

Great news from Dendreon today!

The FDA finally approved the remaining 75% of treatment stations at their New Jersey plant that manufactures Provenge.

This will quadruple their manufacturing capability and greatly help to alleviate some of the current supply/demand problem.

Two more plants in Los Angeles and Atlanta are also expected to be able to begin production in the near future.

Care To Live along with thousands of Patients, Urologists and Oncologists are thrilled that doctors will now be able to treat thousands more men with Provenge, however we will not sleep well until all the men who need Provenge can get it.

Popularity: 13%

Today CTL received an interim response to its two previous FOIA request made to CMS. The documents were retrieved upon a search performed by Dr Louis Jacques. We received 258 pages of which 74 pages were redacted under claimed exemptions of FOIA (5 U.S.C. 552 (b)(2), (b)(5) and (b)(6)).

Although the pdf’s are not in 100% chronological order it is probably easiest to comprehend each of the 5 individual pdfs, from back to front.

1-cms-foia-0221.pdf

2-cms-foia-02211.pdf

3-cms-foia-02-21.pdf

4-cms-foia–02-21.pdf

5-cms-foia-0221.pdf

Popularity: 15%

Matthew Herper, a writer for Forbes magazine and Forbes.com, has a biased, one-directional view of Dendreon’s Provenge, the first and only FDA-approved immunotherapeutic treatment for men with late stage prostate cancer. He continues to trip over his own feet in his attempts to lower the boom on Dendreon and Provenge. Over the past several years he even has attacked Care To Live, a prostate cancer patient advocacy group.

Mr. Herper could care less about the 30,000 men dying each year from an excruciatingly painful disease. He could care less about hurting a company financially that is attempting to cure not just prostate cancer, but many other forms of cancers as well. And he could care less about uncovering the malfeasance at the FDA Continue Reading Race To Undo The Cure »

Popularity: 13%

I prepared for orals expecting a lot of questions. There were not many questions asked by Judge Norris or Judge Martin but quite a few by Judge Cook. Judge Norris and Martin are a couple of salty old dogs and seem a bit more lighthearted then many of their stiffer brethren.

I had 15 minutes, 5 of which I saved for rebuttal. I presented the issue and spoke about how this case was different then most FOIA cases in that we know that there were, and maybe still are, requested documents on the computer of a single individual at the FDA.

We know this by virtue of Richard Pazdur’s admittance that he had the documents on his computer but he deleted them. So in this case the CDER division of the FDA knows where to look. Continue Reading Care To Live Attorney Kerry M. Donahue Argues for Pazdur’s Deleted Documents »

Popularity: 15%

Care To Live Counsel Kerry M. Donahue sent a letter to the Centers for Medicaid and Medicare Services (CMS), as a final gesture to resolve the Freedom Of Information (FOIA) conflicts with their agency. However, if the the status quo remains, and we receive no response, Kerry has already started preparing litigation against them and will file on December 10, 2010, if they choose to go down that road.

(Click picture to enlarge. Download pdf here kerrydonahuecmsletter.pdf)

Popularity: 13%