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Posts Filed Under ‘The Dysfunctional FDA’
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.

Abigail Alliance Plans FDA PROTEST June 28
June 20th, 2011 | Posted by CTLFrank 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
Popularity: 15%
Tags: abigail alliance, Avastin, Compassionate Access Act, FDA, Frank Burroughs
Posted in The Dysfunctional FDA | Post a Comment »
HHS Desperately Needs Transparency Lessons From CMS
April 28th, 2011 | Posted by CTLHuman 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%
Tags: Alison Martin, Care To Live, CareToLive, CMS, FDA, HHS, howard i scher, Katherine Sebilius, Louis B. Jacques, maha hussain, National Cancer Institute, NCI, Richard Pazdur
Posted in The Cause, The Dysfunctional FDA | Post a Comment »
PROVENGE! PROVENGE! GET YOUR PROVENGE HERE!
April 16th, 2011 | Posted by CTLGood 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!
Popularity: 22%
Tags: Dendreon, FDA, Immunotherapy, Prostate Cancer, provenge
Posted in The Cause, The Dysfunctional FDA | Post a Comment »
Care To Live Expects Final CMS FOIA Documents by April 15
March 26th, 2011 | Posted by CTLCare 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%
Tags: CareToLive, cms fda ctl Care To Live, Dendreon, Immunotherapy, Prostate Cancer, provenge
Posted in The Cause, The Dysfunctional FDA, The Lawsuit | Post a Comment »
Dendreon’s NJ Plant Expansion Approved by FDA — FINALLY!
March 10th, 2011 | Posted by CTLGreat 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%
Tags: Care To Live, CareToLive, Dendreon, FDA, Prostate Cancer, provenge
Posted in The Cause, The Dysfunctional FDA | 3 Comments »
Steve Forbes Joins Miller, Gottlieb, and Care To Live in Plea to FDA to Do More
February 7th, 2011 | Posted by CTLDr. 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.
Popularity: 12%
Tags: Dendreon, FDA, Immunotherapy, Prostate Cancer, provenge, Scott Gottlieb, Steve Forbes
Posted in The Cause, The Dysfunctional FDA | 3 Comments »
FDA Trifecta — Gottlieb Calls Em Out, Miller Rallies on the Rail, Hamburg Limps Lamely to Finish
January 16th, 2011 | Posted by Kerry Donahueby 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 »
Popularity: 15%
Tags: abigail alliance, Dendreon, FDA, Frank Burroughs, Henry Miller, Immunotherapy, Kerry M. Donahue, Margaret Hamburg, Prostate Cancer, provenge, Scott Gottlieb
Posted in The Cause, The Dysfunctional FDA, The Lawsuit | 1 Comment »
FDA Sabotages America Again!
January 7th, 2011 | Posted by CTLCare To Live To FDA, “Just Produce the Documents”.
Public servants. Hah! More like royalty in gilded cages. Conspiring in their posh abodes to put the kebosh on a cancer treatment without adequate reasons or transparency into their warped decision making process. They can’t use no favorable Advisory Committee hearings. Not when there was so much money on the table.
We seek confirmation of the corruption and retribution commensurate with the crime.
Who was lobbying the FDA and why?
The Care To Live Birthers are here.
Just produce the documents.
We fully intend to continue to force the issue including the removal of the inner sanctum of corrupt officials at the FDA, the CMS, the NCI and the HHS, who have been sabotaging our medical research, destroying valid, impressive, breakthough treatments and delaying approvals for years while they enrich themselves.
How blatant they are in their inconsistency. For such a statistically anal organization, the FDA can’t add one and one and get two. What a sneaky bunch of manipulating, self enriching bureaucrats, who through ignorance or greed, sabotaged a nation.
We demand consistent parameters for one treatment over another.
Yeah, Provenge is approved now. So what difference does it make?
It is at the very core of our democracy that these “regulatory” agencies, who get such a huge chunk of our tax dollars, actually do the jobs they are overpaid to do.
Transparency and Accountability.
FOIA OR BUST!
Join us!
Popularity: 14%
Tags: cancer, CMS, Dendreon, FDA, HHS, Immunotherapy, NCI, Prostate Cancer, provenge
Posted in The Cause, The Dysfunctional FDA, The Lawsuit | 1 Comment »
Care To Live Attorney Kerry M. Donahue Argues for Pazdur’s Deleted Documents
December 9th, 2010 | Posted by Kerry DonahueI 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%
Tags: Care To Live, CareToLive, CDER, Dendreon, DOJ, FDA, Immunotherapy, Kerry M. Donahue, Prostate Cancer, provenge, Richard Pazdur
Posted in The Cause, The Dysfunctional FDA | 1 Comment »
Care To Live — Dec. 8
November 29th, 2010 | Posted by CTLCareToLive has been notified of its Courtroom and Judge assignment in case 09-4084 CareToLive v. FDA.
Wednesday, December 08, 2010, room 636 - 6th Floor East Courtroom, 9:00 A.M.
Before: Judge Boyce F. Martin Jr., Senior Judge Alan E. Norris and Judge Deborah L. Cook
Oral argument will be heard by this three judge panel on Wednesday, December 8, 2010 at 9:00 a.m. at the Potter Stewart U.S. Courthouse, 100 East Fifth St in Cincinnati, Ohio.
CTL’s filing in the Court of Appeals was in response to the FDA’s refusal to search Richard Pazdur’s computer or the FDA servers for documents that satisfy our FOIA request.
Dr. Pazdur had made a Declaration stating he destroyed all said documents. Kerry states, “Merely asking the fox to count the chickens, without even allowing Plaintiff-Appellant to subject the answers of the fox to any sort of test of accuracy or truthfulness, was improper.”
You can read Kerry’s fine legal filing here: ctlfoiaappellantreplyeditedii030310pdf.pdf
Popularity: 12%
Tags: Care To Live, CTL, Dendreon, FDA, Prostate Cancer, provenge, Richard Pazdur
Posted in The Dysfunctional FDA, The Lawsuit | Post a Comment »