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