CareToLive RSS
Subscribe to the CareToLive RSS feed for up to date news and developments surrounding the legal battle against the FDA and more. (RSS feed reader required)
Subscribe to the CareToLive RSS feed for up to date news and developments surrounding the legal battle against the FDA and more. (RSS feed reader required)
Spread The Word
Please help spread the word about CareToLive. Any of the information found on this website can be distributed and shared freely. We only ask that you provide a link back to this website if you publish our content.
Please help spread the word about CareToLive. Any of the information found on this website can be distributed and shared freely. We only ask that you provide a link back to this website if you publish our content.
Donations
CareToLive is a not for profit corporation; however, donations are NOT tax exempt.
CareToLive is a not for profit corporation; however, donations are NOT tax exempt.
Posts by admin
Provenge is approved!
- Provenge has been approved! Thank you to all who helped achieve this important milestone for cancer patients.
LATEST POSTS
- 11/27/2011 - Care To Live Board Member Ted Girgus Dies of Prostate Cancer
- 09/06/2011 - Care To Live Update on SEC OIG Investigation into April 28, 2009 Dendreon Bear Raid
- 07/13/2011 - 3 Minute Video Explaining Provenge Treatment
- 06/20/2011 - Abigail Alliance Plans FDA PROTEST June 28
- 06/09/2011 - RIP Charles A. Reinwald — Cancer Cure Coalition Founder
- 04/29/2011 - Care To Live Submits Moment of Silence to CMS
- 04/28/2011 - HHS Desperately Needs Transparency Lessons From CMS
- 04/23/2011 - Please Post for Provenge!
- 04/19/2011 - Another Interim Provenge Prostate Cancer Immunotherapy CMS FOIA Response
- 04/16/2011 - PROVENGE! PROVENGE! GET YOUR PROVENGE HERE!
MOST POPULAR
- Setting the Record Straight
- Provenge Is Approved But The Lies Continue
- Provenge Works & Costs the Same as Chemo & Comments by Bishop
- The Bloodshed, Bogus Threats, Birth Defects, Bashers Cover Letter
- PROVENGE WILL BE COVERED BY MEDICARE
- CareToLive sends a Freedom of Information Request to the Centers for Medicare & Medicaid Services
- ASCO Tells CMS It Should Cover Provenge
- The Centers for Medicare and Medicaid Services are requesting comments.
- Dr. Snuffy Myers Advocates For Provenge Treatment
- Senators Specter and Kerry - CMS Has Some 'Splaining To Do
WHATS GOING ON
This Is An Emergency!
We rallied outside the FDA building in Rockville, Maryland on September 18th. Now there are buses riding around Rockville and Washington, D.C., further protesting the shenanigans that took place inside the FDA building, as well as outside.
The FDA has gotten caught up with Wall Street. While it is supposed to be busy with evaluating food and drugs, its employees just can't keep their eyes off the money. So that is how decisions are being made these days.
This Is An Emergency!
We rallied outside the FDA building in Rockville, Maryland on September 18th. Now there are buses riding around Rockville and Washington, D.C., further protesting the shenanigans that took place inside the FDA building, as well as outside.
The FDA has gotten caught up with Wall Street. While it is supposed to be busy with evaluating food and drugs, its employees just can't keep their eyes off the money. So that is how decisions are being made these days.
WE'LL BE BACK
These people traveled from all across the country to protest outside the FDA Building in Rockville, Maryland. The FDA has stopped a safe and effective treatment from getting to men who need it now. The treatment is called Provenge and it treats men who have late stage prostate cancer.
The FDA appointed a panel of experts to help it decide on the safety and efficacy of Provenge. That panel voted 17-0 that Provenge was safe. And it voted 13-4 that Provenge showed substantial evidence it worked. And yet the FDA delayed it. Now it could be a year, a year and a half or it could be three years. It could be forever.
These people will keeping coming back to Rockville and they hope others will join them until the courts, the FDA, Congress or somebody does something about this travesty.
These people traveled from all across the country to protest outside the FDA Building in Rockville, Maryland. The FDA has stopped a safe and effective treatment from getting to men who need it now. The treatment is called Provenge and it treats men who have late stage prostate cancer.
The FDA appointed a panel of experts to help it decide on the safety and efficacy of Provenge. That panel voted 17-0 that Provenge was safe. And it voted 13-4 that Provenge showed substantial evidence it worked. And yet the FDA delayed it. Now it could be a year, a year and a half or it could be three years. It could be forever.
These people will keeping coming back to Rockville and they hope others will join them until the courts, the FDA, Congress or somebody does something about this travesty.
OPERATION ACCELERATE APPROVAL
April 23rd, 2009 | Posted by adminPhase One
Today, Thursday April 23, 2009 at 11:15 a.m. at the National Press Club in Washington DC, CareToLive board member Mike Kearney along with Frank Burroughs of the Abigail Alliance will be asking important questions and monitoring a meeting of some important players from the prostate cancer advocacy community.
Important media will be monitoring this meeting. Mike and Frank are wired for sound by award winning documentary film maker Hilary Birmingham. The documentary producer will also be there getting video of the event and has already interviewed both Mike and Frank this morning.
The meeting information is at the bottom of this blog.
Goal: To speed Provenge to approval and more importantly availability for the patients from an advocacy perspective, following the announcement of success by Dendreon regarding the IMPACT trial.
After careful consideration we have determined that the goal remains to create a groundswell of support by all means available in order to create pressure on all parts of our government to stop acting as bureaucrats stuck to the seat of their chairs and to compel them to take the humane action of super accelerating Provenge approval on behalf of all the late stage prostate cancer patients who so badly need it.
The FDA had one chance to approve Provenge in May of 2007.
They had a 2nd chance in October when Dendreon and the IDMC gave them interim data.
They have a 3rd chance now.
There is no reason this process of approval should take until 2010. Approval can be accomplished by the FDA by making special consideration for a treatment that has already been proven safe and effective for a late stage disease as previously voted by an FDA expert panel and which is designated for a serious class of late stage prostate cancer patients. The patients waiting for Provenge lack good alternatives and they need our help to get Provenge now.
The FDA has the means to take a much more humane approach then they have previously taken, whether it’s by granting the CareToLive Citizen Petition or merely recognizing that this is a special case that merits urgent review at the highest levels of the FDA.
This ground swell can happen, but we can’t do it alone. Pressure needs to come from many sources inside and outside of Washington. If all prostate cancer advocates can come together for this effort then the call will be heard loud and clear throughout Washington and those poised to help can spring to action. The advocacy groups, particularly the large advocacy groups need to step up and advocate for the patients right to have Provenge now.
Late stage prostate cancer patients need Provenge now. If these prostate cancer advocacy groups don’t stand up now (or at least on April 28th when the full data is released by Dendreon) and join the call for immediate approval of Provenge then what are they waiting for and who are they working for? This is the biggest breakthrough for prostate cancer patients in recent history. We ask that the advocates speak up and speak loudly!
We have many friends/supporters of our cause in high places inside and outside the government. They are ready to help but we must turn up the volume on the call for super accelerated approval so as to help them to make it happen.
This is the meeting today. I will update the day’s events soon.
MEDIA ALERT for Thursday, April 23, 2009
WHAT:
Discovery & Challenge: The State of Prostate Cancer Research
A Roundtable Discussion with Leading U.S. Experts
Hosted by the Prostate Cancer Foundation, this roundtable discussion will feature commentary from eight U.S. experts in the field of prostate cancer research and treatment. The program will focus on the following areas:
WHERE:
The National Press Club - First Amendment Lounge
529 14th Street NW, Washington D.C.
and via telephone access
Call-in number: 800/550.7798 (U.S. & Canada) 213/233.3044 (International)
Conference ID: 3154713
Attendees accessing the discussion via phone will be able to e-mail questions during the Q&A period: dzenka@pcf.org.
WHEN: Thursday, April 23
11:00 am - Registration
11:15 am - Program begins and phone line opens
12:30 pm - Program concludes
WHO:
Josh Wolfe, Moderator
Co-founder, Managing Partner of Lux Capital
Editor of the Forbes Wolfe Emerging Tech Report
Alvin Chin, Prostate Cancer Survivor & Advocate, Virginia Prostate Coalition
Donald S. Coffey, PhD, Professor of Urology, Oncology, and Pharmacology and Molecular Sciences, Johns Hopkins University School of Medicine
Captain Melissa Kaime, MD, Director, Department of Defense, CDMRP
Peter S. Nelson, MD,
Professor of Medicine and Oncology
Fred Hutchinson Cancer Research Center and the University of Washington
Howard Scher, MD, Chief of the Genitourinary Oncology
Memorial Sloan-Kettering Cancer Center
Padmanee Sharma, MD, PhD, Researcher
University of Texas M. D. Anderson Cancer Research Center
Jonathan W. Simons, MD
President, CEO and David Koch Chair, Prostate Cancer Foundation
David E. Wheadon, MD
Senior Vice President of Scientific & Regulatory Affairs, PhRMA
S. Ward Casscells - MD, Assistant Secretary of Defense for Health Affairs U.S. Department of Defense.
Popularity: 15%
Tags: CareToLive
Posted in The Cause | 16 Comments »