FDA'S Cber Sipping New Year's Champagne Burst Patient's Bubbles

by Kerry M. Donahue | January 1, 2010 at 10:30 am
1531 views | 89 Recommendations | 7 comments

TIME MATTERS

CareToLive is following in the footsteps of the Abigail Alliance http://abigail-alliance.org, a truly stellar patient advocacy group, who fought the FDA for earlier approval for 16 treatments for late stage patients who were out of options. All 16 have either been approved, or soon will be approved by the FDA, but only after intolerable delays for the patients seeking them, with many patients dying before access was made available. Abigail Alliance stands shoulder to shoulder with CareToLive in pushing for the immediate approval of Provenge.

Provenge is a proven safe and effective immunotherapy with no serious side effects, which trains the body’s own immune system to fight back against prostate cancer. It is a noninvasive, nontoxic treatment for late stage prostate cancer patients, administered in the doctor’s office, to men who have no other viable treatments options.

THE TIMELINE:

November 2006 ― Dendreon completes rolling submission of FDA license application to market and distribute Provenge to needy patients.


March 2007 ― An FDA Advisory Committee, made up of FDA handpicked experts, find Provenge overwhelmingly safe and effective and recommend FDA approval.


April 2007 ― Two FDA employees with disclosed and undisclosed financial conflicts of interest lobby the FDA to delay approval.

May 2007 ― FDA issues a request to Dendreon for more trial data on Provenge, which the FDA believes will take Dendreon three more years to obtain.

August 2007 ― Dendreon determines it can obtain the requested FDA data by shortening the trial length. FDA agrees to reconsider approval when interim and/or final results are compiled.

October 2008 ― Interim data as reported by an Independent Data Monitoring Committee (IDMC) confirms the safety and efficacy of Provenge. FDA still refuses approval.

April 2009 ― Final data released by Dendreon shows that Provenge is a safe and effective treatment for late stage prostate cancer patients. The data are presented at an American Urological Association conference.

May 2009 ― FDA denies our CareToLive Citizen’s Petition (pending for over 2 years) to reconsider the wrongful 2007 FDA decision not to approve Provenge. In the meantime, over 50,000 desperate men die without access.

The FDA promises an expedited review once the new data is formally submitted to the agency by way of an amended Biologics License Application (aBLA).

“We are committed to expeditiously reviewing the new information as soon as it is submitted,” the FDA stated in its response to CareToLive.

July 2009 ― The Clinical portion of the amended biologics license application (aBLA) is submitted to the FDA.

October 2009 ― The Final portion of the rolling submission of trial data is filed with the FDA.

December 2009 ― Provenge is still not approved for late stage prostate cancer patients who are out of treatment options.


The FDA continues to lie about why this treatment has been denied these patients.

No lessons have been learned and no humanity displayed.

The FDA remains dysfunctional with no change in sight.

The new FDA leadership remains oblivious to the mission they are mandated to fulfill ― Better, Safer Treatments For Unmet Needs Without Delay.

 

 

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60
RoryKearney

Welcome to Now Public Kerry. It is about time! I hope this is the first of many op eds by you. You make the world a better place. Thanks for all you do.

Rory and the CareToLive members and supporters.

12
Seeks The Truth

The FDA is now operating as a completely separate branch of the government and basically answers to no one. Sure, there is theoretical oversight by the Congress but let's be honest, the Congressional overseers are nearly completely impotent. It is "unconsiounable" that the FDA could stand by and deny TENS of THOUSANDS of men dying of advanced PCa the benefit of Provenge .... but that's the present state of the FDA affairs. They are UNCONSCIOUS to so many issues. So NOT ONE higher uppity FDA member has taken up the PCa/Provenge cause. Just like NOT ONE of the 60 Democratic Senators could stand up for The Truth and vote against the sleazy Health Care Reform Bill. A Bill that required blatant graft to "buy-off" a Senator form Nebraska and "entitlement" to other states. Not to mention the antics all being performed just before Christmas Eve when virtually ALL Americans have their holiday minds focused much more on friends and family than a Health Care Bill that even their Congressional representatives have fsiled to read in it's ENTIRETY. There is only one solution. That is to change your ways and get ACTIVELY INVOLVED in the "political process." Vote the bastards who are ruining our once great country OUT OF OFFICE....and replace them with folks who think like you do!! Better yet....RUN FOR OFFICE YOURSELF!! In six years we could replace ALL of the House and nearly all the Senate. Would YOU be willing to DEMAND that the FDA stop lying, stone-walling and doing everything in their power to prevent PV from coming to market?? And....if not you,then who???? The FDA has treated our "Citizen's Petition" like a it was an Ebola Virus and has to be "contained." And these same folks SUPPOSEDLY work for US!! And a portion of their wages/benefits are paid by taxes from MEN with PCa!!! How ABSURD is that???? My compliments to Kerry D., CTL, the AA and Patrick Byrne. TRUE American Heroes!!! Seeks TheTruth PS I think Kerry D. looks a bit like Bob Pisani. And both have a last  name that ends in a vowel!!!  

18
LOIS KOSTEL RN, BSN

THANKS KERRY, AND CARE TO LIVE, FOR YOUR DOGGED PERSISTENCE AGAINST THE SURREPTITIOUS DEALINGS OF THE FDA--A GOVERNMENT AGENCY SUPPOSED TO LOOK AFTER THE PUBLIC WELFARE.  IT IS NO WONDER THAT SO MANY ARE WARY OF THE GOVERNMENT TAKING OVER OUR HEALTH CARE.

26
Ted Girgus

As an advanced prostate cancer patient, the first thing I do each morning is turn on my computer in hopes that TODAY the immunotherapy called Provenge is approved. I have been doing this each day since the FDA's own advisory council  said 17-0 it was safe and 13-4 it showed substantial efficacy in 2007. I still hold out hope that the FDA will do the right thing and allow the thousands of men like me to access this drug before its too late. Time is NOT on our side!!! May God bless all those who continue to fight for those of us who no longer can.

17
Kerry M. Donahue

God bless you Ted! Yes the FDA needs to listen to patients and realize this is 2010! Its about the science and the war on cancer...a war the FDA has now become an obstacle to winning.

We have fought them for years and they have shown no ability to learn, to grow, or to change their ways. They are outdated and completely dysfunctional.

The new leadership there seems to be as out of touch as the last.

 

4
Frank Burroughs, Abigail Alliance for Better Access to Devel

From: Frank Burroughs Abigail <?xml:namespace prefix = st1 />Alliance for Better Access to Developmental Drugs             www.abigail-alliance.org Kerry,             It is allies like you and all the folks with CareToLive that are a very important part of the effort to help so many to save and extend their lives.  In your posting you wrote: All 16 have either been approved, or soon will be approved by the FDA…….” Actually all 16 drugs have been approved.  Provenge (of course) is one of several drugs and vacinnes for cancer and other serious life-threatening illnesses that are on our current list of drugs and vaccines the Abigail Alliance is is pushing for earlier access to and approval of.  The Abigail Alliance will keep up the fight!             Frank Perseverance is a great element of success. If you only knock long enough and loud enough at the gate, you are sure to wake up somebody.       Henry Wadsworth Longfellow

2
Kerry M. Donahue

Mr. Burroughs

Right you are. Lets hope that Provenge can be number 17 and that approval comes VERY soon.

 

 

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