Ted Girgus, an energetic man who stood up and fought as hard as he could for what he believed in, lost his battle with prostate cancer on Wednesday, November 23rd.

Ted had hoped to be on Provenge way back in 2007.

Here’s Ted protesting for Provenge approval back in 2008:

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

Ted could have been rebuilding his immune system all these years had it not been for FDA illegally leaked letters disparaging Provenge right after the Provenge Advisory Committee voted to support approval of Provenge. The panelists voted Provenge SAFE by a count of 17 to 0 and voted Provenge showed SUBSTANTIAL EVIDENCE OF EFFICACY by a count of 13 to 4.

A severely conflicted doctor, namely, Dr. Howard Scher, working out of Sloan Kettering in New York City, spearheaded the delay on many fronts. It is Care To Live’s contention that Scher helped write a letter, along with three other doctors, on behalf of Cougar Biotechnology before the March 29, 2007 panel hearing, in which they begged the FDA not to approve Provenge. At that time Scher did not disclose that he was leading a Novacea Asentar trial and a Cougar Abiraterone trial, both products in competition with Provenge. This explains why he was so active in fighting against Provenge approval during the hearing. After the hearing he worked with Alison Martin from NCI on a letter that was illegally leaked to The Cancer Letter by the FDA. The fact that the Food and Drug Administration (FDA), the National Cancer Institute (NCI), the Department of Justice (DOJ), and Congress, all allowed this malfeasance with impunity, while lives like Ted’s were hanging in the balance, is as despicable an act as any for agencies that supposedly are serving the public.

Ted greatly appreciated Care To Live’s fight for Provenge’s approval. He and his family fought right alongside us. Ted remains forever an exemplary American citizen despite the fact that our government, paid for by his hardworking tax dollars, betrayed him.

Here is an excerpt from the last e-mail Ted wrote to CTL:

Hi Gang,

I’ve been keeping a low profile for awhile due to my new prognosis. My doctors have told me that the cancer has affected my kidneys. I’ve been told that I have about 2 months to live. I will contact the Provenge Site where I live but I think I’m past the point that they will accept me.

I want you all to know how special you have made my life and the purpose you have given me and my family.

The Scriptures tell us it’s not how we start our lives that’s important, it how we end it.

You have filled me with strength and purpose and for that I will always be grateful.

God Bless You All and I know I will see you in heaven!!!

Ted

May you rest in peace, Ted Girgus. Thanks for all you did for Care To Live. You were instrumental in the eventual approval of Provenge, and all cancer patients throughout the world owe you a debt of gratitude.

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Frank Burroughs of the Abigail Alliance informs us there is a protest planned at the FDA June 28.

Care To Live urges all people who have a beef with the FDA to make a sign and join them.

Freedom of Access to Medicines, along with the Abigail Alliance for
Better Access to Developmental Drugs, and others plan to hold a peaceful
protest outside the FDA hearings on Avastin on June 28th, 2011.

The protest is in support of the fight of women to choose the
life-saving drug Avastin, and the issue of better access to promising
developmental therapies for cancer and other serious life threatening illnesses.
An estimated 17,500 women with incurable metastatic breast cancer
currently rely on Avastin to stay alive. With your help, they and their
doctors will remain free to choose Avastin.

Due to the actions of the U.S. Food and Drug Administration, these
women’s lives are threatened. Defend these women’s right to choose the
medicines that keep them alive today and you will be protecting your life
tomorrow.

The location of the June 28-29 hearing will be the Great Room on the
FDA White Oak Campus located at 10903 New Hampshire Avenue, Silver
Spring, MD 20993.

For more information about the White Oak Campus, please click on this www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm[1]
More details regarding the protest will soon be available at:
http://www.fameds.org/protest.php

Abigail Alliance for Better Access to Developmental Drugs
www.abigail-alliance.org[2]
8881 White Orchid Place
Lorton, VA 22079
703-646-5306

COMPASSIONATE ACCESS ACT: The Abigail Alliance along with others is
in the process of very significantly reinvigorating the Compassionate
Access Act in the U.S. Congress.

DOCUMENTARY: Sometime mid to late this year a documentary featuring
the Abigail Alliance will be coming out!

ALSO, the Abigail Alliance has a VERY tight budget, so your help
KEEPS US GOING.

Donate to Abigail Alliance

Links:
——
[1]
http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm
[2] http://www.abigail-alliance.org

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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 »

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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/

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Good News! Provenge is becoming increasingly available. Dendreon is ramping up the supply following the recent approval of the remaining 75% of their New Jersey plant.

To find out more about Provenge, a first in class immunotherapy treatment for prostate cancer, click this link Provenge.com.

To find out where provenge is available near you, go to the bottom left of that page to this link Find a PROVENGE Provider. Then, insert your zip code to find the locations in your area.

Recently conducted channel checking indicates that demand remains strong.

That data suggests:

The number of patients prescribed Provenge within their sample is up 22.7% sequentially, while the number of new patients who actually received the treatment is up 66.7%.

This is good news indeed!

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Today Care To Live received additional documents from the Center of Medicaid and Medicare Services in response to our Freedom of Information (FOIA) requests.

part-1-cms-foia-3_30_11.pdf

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part-10-cms-foia-3_30_11.pdf

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Yes!

Patients and Advocates. I come to praise CMS, not to censor them.

As Care To Live expected, the Centers for Medicare and Medicaid Services announced today that Dendreon’s Provenge will be covered. There will be a brief comment period again, before this decision is formally made final. Approval of  Provenge immunotherapy, as well as payment for Provenge, were an uphill battle, but the next step, acceptance and usage, was well worth our efforts.

Thousands of men are currently receiving and loving Provenge!

As our most recent CMS foia documents (soon to be published here) will show, CMS created a firestorm when they announced that they were going to review Provenge to determine coverage.

A groundswell of support, by patients, doctors, congress, and advocates, came forth to push for national coverage.  We thank each and every one of you wholeheartedly. Provenge approval and accessibility was a labor of love/hate for many of us. CMS writes in their Decision Summary,

“The Centers for Medicare and Medicaid Services (CMS) proposes that the evidence is adequate to conclude that the use of autologous cellular immunotherapy treatment - sipuleucel-T; PROVENGE® improves health outcomes for Medicare beneficiaries with asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone refractory) prostate cancer, and thus is reasonable and necessary for that indication under 1862(a)(1)(A) of the Social Security Act (the Act).”

CMS also said it is “requesting public comments on this proposed determination pursuant to section 1862 (l) of the Act. After considering the public comments, we will make a final determination and issue a final decision memorandum.”

CMS decision memo link:

http://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=247&ver=7NcaName=Autologous+Cellular+Immunotherapy
+Treatment+of+Metastatic+Prostate+Cancer&bc=BEAAAAAAEAAA&

Dendreon Press Release link:

http://files.shareholder.com/downloads/DNDN/1208526489×0x455544/b045427e-a6cd-4064-86db-6e43b971f829/DNDN_News_2011_3_30_General.pdf

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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.

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Dr. Scott Gottlieb and Henry Miller (see blog below) recently criticized the FDA for its go slow, risk adverse nature, which is stifling innovation and costing patients quality of life time with family.

Here is the link to Steve Forbes recent article called: How the FDA May Kill Millions of Us.

http://www.forbes.com/forbes/2011/0214/opinions-steve-forbes-fact-comment-fda-may-kill-millions.html

Mr. Forbes states, “A more fruitful approach would be to overhaul the FDA and remove its capricious hurdles.”

The FDA needs patient advocates on staff with real authority to help patients, who can work with patient advocacy groups to enable patients to gain access to innovative treatments sooner. The FDA needs to balance the wealth of statistically rigid bureaucrats who are unable to understand how to weigh benefit - risk in a meaningful manner.

The FDA needs to accelerate approvals and streamline the process. An ongoing example of FDA incompetence is the still non-approval of Dendreon’s NJ Provenge plant, whose request they have had for 3 months now…….while men still cannot obtain the treatment due to supply shortages.

Prostate cancer patients are tired of dying while waiting for the FDA to do its job.

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by Kerry M. Donahue

FDA commissioner Margaret Hamburg recently defended the FDA against criticisms leveled by former FDA Deputy Commissioner Dr. Scott Gottlieb and Hoover Institute fellow Henry Miller. She took issue with the idea that the FDA is not following the mandates of Congress to get safe and effective new treatments to patients in a timely way, particularly late stage patients with few, if any, viable alternatives.

Of course those who followed the Provenge approval process with CareToLive understand that FDA figurehead Hamburg is baffled, befuddled and completely out of touch with the reality of the situation. Ms. Hamburg needs to look no further than the case of Provenge and the now 15 other effective treatments for late stage diseases that heroes like Frank Burroughs at the Abigail Alliance http://abigail-alliance.org/ supported, and which were all eventually approved for treatment of life threatening diseases. Unfortunately not before hundreds of thousands of patients died, sometimes from terrible and painful diseases, without ever having been able to obtain these treatments.

The fault lies squarely with the FDA process and their failure to prioritize and accelerate review as demanded by Congress, and by humanity itself. Continue Reading FDA Trifecta — Gottlieb Calls Em Out, Miller Rallies on the Rail, Hamburg Limps Lamely to Finish »

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