A Glimpse Of The Provenge Rally At FDA HQ
4 CommentsBy Ed Silverman // September 20th, 2007 // 7:53 am
Earlier this week, nearly 200 people protested in front of FDA headquarters in Maryland against the agency’s decision to delay approval of Dendreon’s Provenge prostate-cancer vaccine and to agitate, in general, for greater access to experimental cancer meds. The gathering follows months of controversy over the FDA’s flip-flop on Provenge and subsequent controversy over a pair of agency panel members who last spring voted against approval and later wrote the agency urging caution. (Please click on the photo to see more detail).
Since then, the FDA has begun probling allegations of conflicts of interest among panel members, according to sources who are familiar with this episode. Meanwhile, some patients - and Dendreon investors - have filed a lawsuit against the FDA, attempting to force the agency to make Provenge available. But taking a chapter out of the book written by AIDS activists two decades ago, prostate-cancer patients are moving quickly to stage these kinds of protests. Here’s the speech given by Charlie Reinwald, who heads Cancer Cure Coalition.
Lisa
Ed,
We should have a new Poll!
Do the Dinosaurs “stay” or GO”
Health Blog : Watchful Waiting on AstraZeneca's Prostate Cancer Drug
[...] for hormone-refractory disease, shows how badly patients want new options. (See Pharmalot’s post on a demonstration by Provenge advocates outside FDA [...]
Ernest swauger
The really sad part is at the beginning of the rally, it was announced that the Commissioner would only talk to us if we cancelled the rally. If the commissioner would talk to us there would be no need for a rally.
“A true leader has the confidence to stand alone, the courage to make tough decisions, and the compassion to listen to the needs of others. He does not set out to be a leader, but becomes one by the equality of his actions and the integrity of his intent.”-Douglas McArthur
Tony F
Ed, as an attendee at the Cancer Rally at the FDA (and my first, despite having ample opportunity to attend protest rallies in the 60’s), it was impressive to see so many people from all across the country take their time and funds to insure they were there for CANCER patients–not just for prostate cancer patients.
I spoke with Frank Burroughs and Steve Walker of Abigail Alliance; Kerry and Mrs. Kerry Donahue, the attorney for CareToLive which has filed the lawsuit against the FDA for an INJUNCTION allowing terminal patients and their doctors to choose the best therapy–including as yet unapproved by the FDA, albeit safe, treatments; Arnie and Mrs. Mass advocates from Chicago; prostate cancer patients Ray M. and Bruce Tower–the latter from a small East Texas town– who have both taken Provenge and who attribute their continued survival with a good Qualtiy of Life to Provenge; and folks from New Jersey, PA, VA, FL, TX and all the way across the country from California.
There was also an 18 year old young man with a sign about his experience with cancer and who appeared to be asking the FDA for help with his case. There is a photo of this young man here 6th row from top on far left at the beginning of the row:
http://picasaweb.google.com/ttpotser/RallyForCancerPatientsAtTheFDA
Bruce Tower’s story actually was most heart-rending bringing tears to my eyes as to exactly how badly his condition had been over the years which included strong radiation causing scaring and necessitating the installation of stents into his kidneys and out his back and down to collecting bags on his legs; hormone therapy which caused female mammary tissue to grow and which necessitated a mastectomy on one side; steroid treatments resulting in a weight gain to over 300# and a myraid of other medical maladies which was a litany of heart-tearing events. It can be seen and heard here: http://www.youtube.com/watch?v=RmlDsIJjQIw
It was difficult NOT to have one’s resolve INCREASED after hearing the 2 patients speak of their own personal happenstances and of their belief that Provenge had both extended their lives AND given them excellent Quality of Life.
Other groups supporting the Rally were from the Sarcoma Foundation who said that terrible disease has been in trials for 12 years and have used all the available cancer patients and another trial is needed without having more new patients to enroll… 12 years is TOO LONG to bring this drug beneficial to only a few… including children as I understood it… who get this terrible disease.
Cancer Cure Coalition was well represented also with a speaker and I was pleased to see several organizations combining to make the Rally a success and presenting a UNITED front to the FDA for early access to cancer treatments in terminal cases.
Lastly, it was mentioned that Congress will be taking up the “Access Act” which will allow faster access to treatments for terminal patients. Let’s all get behind this for the benefit of those in such dire need.
… and Thank You!, Ed, for keeping this topic in front of the public!!