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Posts Tagged ‘writ’
Provenge is approved!
- Provenge has been approved! Thank you to all who helped achieve this important milestone for cancer patients.
LATEST POSTS
- 02/06/2012 - Great Provenge News Released At ASCO
- 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
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.
CareToLive Sends Writ to Supreme Court of the United States
October 27th, 2008 | Posted by CTLWhile the FDA continues to tow the untenable line they have chosen and while they continue to refuse to admit to their mistakes, much less take any action to fix them, Patients including CareToLive members continue to suffer.
This recent note was received from a very loved member of CareToLive:
That’s how I feel. Today my PSA is 300+ and doubling every 2 months. I did participate in a NCI Prostvac study in Bethesda. It slowed my disease for a while but I was recently dropped from the study due to disease progression in bone scans. The NCI doc recommended I get taxotere ASAP and did mention some past research suggesting following vaccine therapy with chemo enhances the effect of chemo. I’ll keep a happy thought, but what really maddens me was the study doc’s analysis that I simply had too much tumor mass for the vaccine treatments to overcome. I can only think of what might have been the outcome if I could have had Provenge treatments a year ago May when my PSA was moving through the 12 to 18 range. The latest interim report that a 20% survival improvement doesn’t quite cut it felt like a stake through the heart. Statistics rule.
Out of options, I’ll try the taxotere and hope for the best. I’m frustrated, tired, and out of energy for fighting the FDA, BUT I want you to know that I believe that God has a special place in heaven for you and your friends who put so much fight into representing people like me.”
We at CareToLive are humbled that a patient that is fighting for his very life would take the time to thank us. Tonight before you go to bed everyone say a prayer for all those men who are currently suffering from this dreaded disease.
It is for him and others like him and the patients of the future that we continue the fight. We just completed our writ for the Supreme Court which can be found here (Word document) or here (PDF document).
While I have no illusions about the chance that the Supreme Court will grant our writ of certiorari if by chance they did grant it then I am confident we would win it. The argument put forth is legally sound. The Court was wrong to dismiss the case on jurisdictional grounds.
Such a writ is basically a request that the Supreme Court review the matter. If they grant cert it would mean that they have agreed to review the case and invite the parties to submit briefs and make oral argument. If they deny cert then they do not review it.
Meanwhile, while CBER head Jesse Goodman has the power to reconsider Provenge based on the Citizens Petition filed by CareToLive he seemingly lacks the courage and the fortitude to do so, even though it is clearly the humane thing to do. Instead he chooses to ignore the citizens and he chooses not to respond to the numerous letters and e-mails sent to him from CareToLive since his January 2008 response that said: they are still actively considering the petition, but need more time. CBER, anyone home, hello, hello!
Popularity: 10%
Tags: Jesse Goodman, supreme court, writ
Posted in The Cause, The Dysfunctional FDA | Post a Comment »