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:
- The current prevalence of prostate cancer
- Reaching beyond the PSA screening debate
- Promising scientific breakthroughs
- Challenges ahead for research and discovery
- Funding for continued research
- Models for furthering progress
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
April 23rd, 2009 at 9:07 am
The FDA needs to get to work and fast. There’s no good reason for them to drag their feet. They should be pro-active on matters like this and not just sit back and wait for the company. I don’t now why the FDA doesn’t work more like a partner with companies like this instead of an obstacle.
People die and they should at least have the option of drugs like this as long as they’re safe.
The sooner the better so we can get the day traders out of the stock and the false rumors.
papergains.blogspot.com/2009/04/dendreon-updated.html
papergains
April 23rd, 2009 at 9:10 am
My husband died 3 years ago from the effects of the “cure” for his prostate cancer. The radiation burned a hole through his bladder. We suffered horribly. If he were alive today and this drug became available there would be no end to the extent I would go to obtain it. Do the FDA people not have relatives and friends who have this cancer? What is the harm compared to radiation and chemotherapy, other than it would take a lot of money out of the pockets of those profiting from these treatments. What can I do to help?
Glenda Paschal
April 23rd, 2009 at 11:24 am
ther are products out there the fda approved that if used may cause certain cancers what up provenge works this is the us. wake up and save lifes. all people that are sick need this. every day that goes by people die. this cold lead for other drugs to fight cancer. RON W
April 23rd, 2009 at 2:35 pm
I need it. PLEASE
April 23rd, 2009 at 2:42 pm
There should be a separate standard for efficacy for potential treatements in early stages that show a trend towards efficacy with few side-effects. Provenge only missed their primary end point by a very small margin. Given the side-effct profile and trend towards a statistically signifcant result, a separate standard could have allowed for temporary approval WHILE additional studies such as IMPACT are being completed and analyzed. The FDA must err on the side of patients NOT politics!!
Patients NOT Politics!!!
April 23rd, 2009 at 3:07 pm
The role and mandate of the FDA is to provide a supply of safe and effective products for patients.
Provenge through its clinical development plan has shown it is safe (Adv Board 17-0), effective (13 - 4) has met the above requirements. Most recently, released news suggests (data to be shown on the 28th) that the product performs better than the standard of care. (if Dr Gold lied lock him away forever and put him in a jail with “bubba”).
While the FDA is charged with the protection of the american public based on the medicines distributed, the FDA has changed its role and is being taken its function to a different dimension by self interest and big-pharma. THrough interventions of self-righteous experts who are interested in promoting their individual careers and interest.
DO THE RIGHT THING. HOW CAN YOU SLEEP AT NIGHT ?
(ps who know who you are, can you go to the mirror and look yourself in the eye and think of the moments that you have robbed individuals of being with their loved ones before they passed and not bow your head in same ? ) You know who you are,… can you sleep at night….
April 23rd, 2009 at 3:07 pm
The role and mandate of the FDA is to provide a supply of safe and effective products for patients.
Provenge through its clinical development plan has shown it is safe (Adv Board 17-0), effective (13 - 4) has met the above requirements. Most recently, released news suggests (data to be shown on the 28th) that the product performs better than the standard of care. (if Dr Gold lied lock him away forever and put him in a jail with “bubba”).
While the FDA is charged with the protection of the american public based on the medicines distributed, the FDA has changed its role and is being taken its function to a different dimension by self interest and big-pharma. THrough interventions of self-righteous experts who are interested in promoting their individual careers and interest.
DO THE RIGHT THING. HOW CAN YOU SLEEP AT NIGHT ?
(ps who know who you are, can you go to the mirror and look yourself in the eye and think of the moments that you have robbed individuals of being with their loved ones before they passed and not bow your head in same ? ) You know who you are,… can you sleep at night….
April 23rd, 2009 at 3:19 pm
The prostate cancer patients need the drug right now !
April 23rd, 2009 at 3:28 pm
I’ve been following Dendreon for 3 years now and initially I was in it for the stock potential. So I spent every waking moment researching Provenge, the Doctors, and the company inside and out.
Most people know about the CONFLICTS OF INTEREST by Drs. Scher and Hussain, but it goes beyond them.
SA (Sanofi Aventis) a french owned company which makes TAXOTERE-the chemo drug currently used for most cancers has made billions and stands to loose billions if Dendreon is approved by the FDA. SA has not only paid three doctors, but also lobbied heavily to ensure Provenge is not approved.
Doubt me, follow up on past FDA and congressional leaders who’ve accepted money from SA, you’ll be disappointed and overwhelmed with disgust.
April 23rd, 2009 at 4:25 pm
The FDA has no business being in business. Get the government out of our bedroom, our wallets, and our relationship with our doctors. The Federal Government only has 2 Constitutionally Mandates roles - fight wars and manage the federal courts. Everything else is a usurpation of the Rights of Man and needs to be abolished.
April 23rd, 2009 at 5:12 pm
This is a safe, no non-sense drug that extends life. No other drug on the market can do this as safe and effective, with little side effects. FDA MUST FAST-TRACK YESTERDAY!!!!!! For the good the PEOPLE!!!!!
April 23rd, 2009 at 5:33 pm
APPROVE PROVENGE NOW FDA !!!
April 23rd, 2009 at 5:36 pm
FDA MISSION - PROTECTING AND PROMOTING YOUR HEALTH.
i WONDER WHOSE HEALTH WAS BEING PROTECTED WHEN PROVENGE WAS REJECTED MR COMMISSIONER ? THERE WAS MORE PROMOTION OF CHEMO-EMPIRES AND SELF INTEREST BOTH INTERNAL AND EXTERNAL TO FDA.
APPROVE PROVENGE.
April 24th, 2009 at 5:39 am
I am so disgusted with the internal politics at FDA - particularly the individual who single handedly shutdown the 2007 study and forced Denderon to go another two years to show once again, the safety factors in the drug Provenge. What excuse will they have this time around?
He overruled the FDA Commissioner and an 18 member panel of experts. How can this happen??? This man and his coharts should be demoted and turned out to pasture. We don’t need self serving government employee’s who apparently are taking their advice from foreign lobby interests on behalf of the French Sanifi Adventis. You should be making decisions in the best interests of the American public. Hopefully, a congressional investigation of the FDA will follow if they refuse to approve this drug immediately. On second thought we need an investigation regardless - find out and take action on the process that occurred in 2007. I’m for punishment!!!
April 24th, 2009 at 5:39 am
I am so disgusted with the internal politics at FDA - particularly the individual who single handedly shutdown the 2007 study and forced Denderon to go another two years to show once again, the safety factors in the drug Provenge. What excuse will they have this time around?
He overruled the FDA Commissioner and an 18 member panel of experts. How can this happen??? This man and his coharts should be demoted and turned out to pasture. We don’t need self serving government employee’s who apparently are taking their advice from foreign lobby interests on behalf of the French Sanifi Adventis. You should be making decisions in the best interests of the American public. Hopefully, a congressional investigation of the FDA will follow if they refuse to approve this drug immediately. On second thought we need an investigation regardless - find out and take action on the process that occurred in 2007. I’m for punishment!!!
April 26th, 2009 at 5:39 am
What eas the outcome of this meeting?
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