Is there any real purpose to the FDA? Do people really expect drug companies to make s%#$ that kills their own customers???
And let's not forget that pretty much half the stuff they approve usually gets recalled later on anyways. Not to mention the fact that it prevents many life-saving drugs from reaching the market in time. Nor does the testing process help the cost of the drugs later on either.
Oh yeah, did I mention that cannabis is actually REALLY effective at stopping the nausea associated with chemotherapy yet the FDA still won't approve of it? Not to mention a broth of other potential products that they know they would have less control over if they approved of them.
This depicts real Americans protesting against an illogical, harmful and, certainly suspicious; perhaps, corrupt decision by an anachronistic and dysfunctional agency of big government. Good luck you will need it! Requests for assistance in this noble effort from members of Congress have, so far, produced only vapid platitudes...well written promises from your elected representatives or staff to keep their eye on this issue. Hell, we can keep our eye on it. We want action. Men are dying!
Maybe the good old heartland of America will come through. A smart lawyer and a courageous judge in Ohio may provide the impetus. Perhaps an honorable FDA employee will come forward to provide testimony to right this terrible injustice. Maybe not all members of Congress will be so timid and hopefully some will show some backbone and common sense and do the right thing to cause approval of Provenge now!
Heartbreaking. 50% of our population will probably develop prostate cancer if they don't die from heart attack or stroke. And many more African Americans. FDA panel voted Provenge effective and safe with only a slight fever side effect, but final approval was witheld. By the time the "final results" of the Phase 3 are in thousands of men who could have used it and lived will have died. Somebody's husband, father, grandfather, son, brother, best friend. Heartbreaking.
It was bad enough that Provenge was denied due process because of Dr. Pazdur's shenanigans and because doctors on the panel with conflicts of interest (it benefitted them financially and politically if Provenge was not approved) wanted to derail Provenge; but add to that the fact that now that the FDA has absolute undeniable proof of the misdeeds, yet day after day goes by without the FDA admitting they made a mistake and FIXING IT.
The FDA did their job. The flunked provenge because it failed all endpoints and that is DNDNs fault. They tried to do it on the cheap rather than doing a partnership they promised in 04. If DNDN had done a partnership on provenge in 04 it would probably be on the market right now,so instead of attacking the FDA maybe your anger should be pointed at DNDN management and BOD.
Ytb, what's your point? The FDA knew that going in and not only did they accept the provenge NDA but they gave it fast track designation. The FDA agreed to look at survival for acceptance. Provenge showed stat significant improved survival. The FDA panel voted 17-0 for the safety and 13-4 for survival efficacy. Bottom line, it is the corruption of Dr. Scher and his extraordinary lobbying against approval that caused this injustice. I just hope he is brought to justice for his criminal act.
The sad part is that provenge was denied because of corruption in the FDA. Dr. Scher had huge conflict of interests and took extraordinary steps to delay Provenge and line his pockets. His involvement with Novacea and Proquest while sitting in judgement of Provenge was criminal and should be delt with by the attorney general.
While the media prattles on about unsafe drugs being approved (vioxx, avandia et al), MILLIONS of Americans die prematurely because terminal patients are not allowed access to potentially life extending drugs. It's my body...the decision to use experimental drugs/therapies that have shown clinical evidence of safety and efficacy is best left to the terminally ill patients and their doctors...period.
Is there any real purpose to the FDA? Do people really expect drug companies to make s%#$ that kills their own customers???
And let's not forget that pretty much half the stuff they approve usually gets recalled later on anyways. Not to mention the fact that it prevents many life-saving drugs from reaching the market in time. Nor does the testing process help the cost of the drugs later on either.
Alternate2GOP 3 years ago
Oh yeah, did I mention that cannabis is actually REALLY effective at stopping the nausea associated with chemotherapy yet the FDA still won't approve of it? Not to mention a broth of other potential products that they know they would have less control over if they approved of them.
Alternate2GOP 3 years ago
Better get the beachballs.
FartheadOgre 4 years ago
look up blood electrification and ozone treatment cure EVERYTHING!!!! with out meds
420bmxer 4 years ago
Scrap the FDA
BWF89 4 years ago 4
"...and it's measured by me, not you."
Damn right, well said.
nakedcomputing 4 years ago 4
This depicts real Americans protesting against an illogical, harmful and, certainly suspicious; perhaps, corrupt decision by an anachronistic and dysfunctional agency of big government. Good luck you will need it! Requests for assistance in this noble effort from members of Congress have, so far, produced only vapid platitudes...well written promises from your elected representatives or staff to keep their eye on this issue. Hell, we can keep our eye on it. We want action. Men are dying!
brange1 4 years ago 5
Maybe the good old heartland of America will come through. A smart lawyer and a courageous judge in Ohio may provide the impetus. Perhaps an honorable FDA employee will come forward to provide testimony to right this terrible injustice. Maybe not all members of Congress will be so timid and hopefully some will show some backbone and common sense and do the right thing to cause approval of Provenge now!
brange1 4 years ago 3
Good job! Keep beating the drums.
iblong2 4 years ago 4
Heartbreaking. 50% of our population will probably develop prostate cancer if they don't die from heart attack or stroke. And many more African Americans. FDA panel voted Provenge effective and safe with only a slight fever side effect, but final approval was witheld. By the time the "final results" of the Phase 3 are in thousands of men who could have used it and lived will have died. Somebody's husband, father, grandfather, son, brother, best friend. Heartbreaking.
fwfassett 4 years ago 4
It was bad enough that Provenge was denied due process because of Dr. Pazdur's shenanigans and because doctors on the panel with conflicts of interest (it benefitted them financially and politically if Provenge was not approved) wanted to derail Provenge; but add to that the fact that now that the FDA has absolute undeniable proof of the misdeeds, yet day after day goes by without the FDA admitting they made a mistake and FIXING IT.
az09abcdefg 4 years ago 6
WOW!! What an excellent testimony! I'm speechless......
The FDA is simply WRONG!!
achchhaa 4 years ago 5
WOW!! What an excellent testimony! I'm speechless......
The FDA is simply WRONG!!
achchhaa 4 years ago 5
Very powerful and from the heart! I still have tears on my cheeks as I type. Approve Provenge NOW!
Gabby
Gabby12605 4 years ago 5
The FDA did their job. The flunked provenge because it failed all endpoints and that is DNDNs fault. They tried to do it on the cheap rather than doing a partnership they promised in 04. If DNDN had done a partnership on provenge in 04 it would probably be on the market right now,so instead of attacking the FDA maybe your anger should be pointed at DNDN management and BOD.
ytb333 4 years ago
They didn't just "flunk" it, they forcibly prevented people from using it - and many people have died as a result. That's murder.
No one has a right to force people to not take any drug they individually think is worth the risk.
kylben 4 years ago 4
Ytb, what's your point? The FDA knew that going in and not only did they accept the provenge NDA but they gave it fast track designation. The FDA agreed to look at survival for acceptance. Provenge showed stat significant improved survival. The FDA panel voted 17-0 for the safety and 13-4 for survival efficacy. Bottom line, it is the corruption of Dr. Scher and his extraordinary lobbying against approval that caused this injustice. I just hope he is brought to justice for his criminal act.
zino0 4 years ago 4
The sad part is that provenge was denied because of corruption in the FDA. Dr. Scher had huge conflict of interests and took extraordinary steps to delay Provenge and line his pockets. His involvement with Novacea and Proquest while sitting in judgement of Provenge was criminal and should be delt with by the attorney general.
zino0 4 years ago 5
Great job on the Rally at the FDA.
This issue affects all Americans.
While the media prattles on about unsafe drugs being approved (vioxx, avandia et al), MILLIONS of Americans die prematurely because terminal patients are not allowed access to potentially life extending drugs. It's my body...the decision to use experimental drugs/therapies that have shown clinical evidence of safety and efficacy is best left to the terminally ill patients and their doctors...period.
insure2020 4 years ago 4