The FDA should approve Provenge now!
May 21, 2007
It could be years before Provenge is approved and available to patients. There is a risk that it could be lost forever.
It could be years before Provenge is approved and available to patients. There is a risk that it could be lost forever.
May 24, 2007 at 1:50 am
NO question about it. EVERY immunologist on the Advisory Committee voted to approve. EVERY member of the committee voted that the treatment is safe. These patients NEED options. The FDA turned its back on terminal cancer patients and left them to die. WE need to tap the FDA on the shoulder and get them to turn back around and face the patients, SEE the human suffering and the anguish, KNOW that Taxotere is not really an option (50% of men will not take it, they’ll just choose death with dignity). Let’s give them DIGNITY and help them FIGHT off death (34% of Provenge patients alive at 36 months, only 11% of those on placebo)! APPROVE PROVENGE NOW!
May 24, 2007 at 5:37 am
It’s incredibly alarming how we have allowed the FDA to be controlled by Wall St. at the expense of dying patients. Any lucid objective observer can see that the issuance of the CR letter for Provenge was dictated by those large pharmaceutical companies that have the most to lose when their barbaric chemotherapeutics are replaced by safe and effective immunotherapies like Provenge.
The FDA’s Advisory Committee (AC) voted 17-0 that Provenge is safe. They also voted 13-4 that it’s effective in improving survival in terminal prostate cancer patients. In the absence of illegal manipulation of the FDA, this should have been the tipping point for FDA approval of Provenge. Instead, one of the most horrific cases of government corruption ever has reared its ugly head.
One need look no further than the conflicts of interest associated with the only two AC members that have openly criticized Provenge, Dr. Howard Scher and Dr. Maha Hussein. Both appear to have undue influence within the FDA and both are currently receiving funding from large pharmaceutical companies to run trials involving toxic chemotherapeutic compounds that will be displaced in the market by Provenge. It’s almost too obvious.
The current Provenge debate represents a watershed moment regarding the future of our society. Will we continue to allow the FDA and likely other parts of our government to be controlled by outside forces at the expense of our general well being? It is my hope that we take advantage of the obvious missteps made public by the FDA’s recent treatment of Provenge to begin to root out the traitors hiding within the halls of our government.
May 24, 2007 at 3:31 pm
No question about it. EVERY immunologist on the advisory committee voted to approve, EVERY member of the panel voted that the therapy was safe. Let’s bring some hope and choice to a terminal patient group without either at this time. Taxotere is obviously not viable, over 50% of men will choose DEATH before Taxotere. Let’s bring those men hope and choice and the chance of life. 34% of men on Provenge were alive at THREE YEARS! Only 11% of men on placebo were alive and only 2 of those had not received the ’salvage’ version of Provenge. THIS THERAPY WORKS!
Do no harm. Bring new hope. APPROVE PROVENGE NOW!
May 24, 2007 at 4:38 pm
What an outrage. The panel has been dismembered by the FDA and this decision makes a mockery of the entire process. What harm could possibly come from approving a drug that the panel unanimously safe? If ever a drug cried for approval and patients lives depended on approval it is this drug. This situation screams of corruption. Sharon
May 26, 2007 at 9:13 am
FDA is playing the role of God. She decides for the cancer patients that Provenge, a very safe therapy that we are 95% confident it will extend life, is not worth taking and dying is a better option for them. Such act is unethical and against the common interest of all. It should be rectified immediately.
May 26, 2007 at 2:27 pm
I am happy that Provenge was not approved outright. It was the wise thing to do to ensure that it is safe and effective before letting it get to market. Cancer patients already spend so much on drugs we must ensure that they are truly effective. The FDA’s approach is wise, wait and see. If someone really wants to get Provenge right now, they can get in the phase III trial underway. Why should sick people have to folk out $100,000 a treatment for something that is not sure to be really effective? Perhaps only greedy and foolish biotech investors are behind this effort. They should be ashamed of themselves for trying to profit off the sick.
Have a nice day and I hope the FDA and Congress show you all the door.
May 26, 2007 at 3:26 pm
If you had cancer would you like to wait and see? I think not. You would be one of those patients that moan the loudest.
May 27, 2007 at 4:09 pm
Isn’t our country about free enterprise. If the FDA finds its role in profit protection, then what do small companies or individual researchers have as incentive to provide exceptional cures. Perhaps they should just sell their research over to the large drug companies who control the current promise of new drugs. After all, the large established drug companies have already lobbied and swayed interest for themselves.
Perhaps leaving the country will soon be the best option for the best treatment of PC. If put in the FDA’s “prove you can handle any risk” position, shouldn’t a US company should sell out to foriegn owners.
May 27, 2007 at 4:41 pm
Yeah, yeah yeah. The FDA is Satan…etc. etc. You are the same type of folks who moan when the FDA lets an unsafe drug hit the market or a bottle of snakeoil that does nothing, then you scream “Where are the safeguards??? Where was the testing ????” “How could this happen???!” You can’t have it both ways. Don’t forget Provenge did not hit its primary targets in either phase III trial. The trials were small. They did not meet the normal standards of effectiveness checking. Why should Provenge get a “free pass” and a drug like Genasense be held to a higher standard? Why not just let drug makers sell anything to anyone because it “might” help (for $100,000+ a pop). Like I wrote above, anyone who really wants to try Provenge can do so right now with the phase III trial currently underway. Access is not a problem. I suspect you are mostly sour investors who lost your shirt in this. You should have taken profit in the 20’s and headed for the exits until final word came from the FDA. Your greed got you a nasty loss. Welcome to biotech where fortunes are made and lost.
The FDA might the RIGHT call here. Besides there are several other drugs coming up for regulatory approval in refractory prostate cancer soon. Some have far better results than Provenge. Wouldn’t you rather have a proven effective drug that you pay $100,000 for, than one where your not really sure? If I was shelling out $100,000, I would like to know that the product works. Would you buy a car that way???
May 28, 2007 at 6:26 am
If you walk up to a swimming pool and see a man drowning, you have a choice to throw him a Coast Gaurd approved life ring that floats and that has been shown to save people lives,what do you do ,a normal person would throw the life ring to save a life and, if you didn’t in CA. you would be held liable for that mans death if you failed do do so… Here you have The FDA with a life saving drug and dieing PC Patients and DR VON E is refusing to let them have the drug ,AFTER HIS ON PANNEL SAYS IT IS SAFE AND WORKS he prefers to let them die, HE SHOULD BE HELD TO ACCOUNT FOR THESE MURDERS….WHO IS PROTECTING THESE PC PATIENTS FROM THE FDA AND DR VON DEATH
WHEN THE RUBBER HITS THE ROAD THIS IS WHAT IS ALL ABOUT DR VON MONEY POLTICS AND BP KILLING THESE PATIENTS
May 28, 2007 at 11:35 pm
Stop_Moaning Says:
May 26th, 2007 at 2:27 pm
“Why should sick people have to folk out $100,000 a treatment for something that is not sure to be really effective?”
They do not “have to” they have a choice. If you were dying what other choice do you have? To die and take your money (insurance $) with you?
Stop_Moaning Says:
“Like I wrote above, anyone who really wants to try Provenge can do so right now with the phase III trial currently underway.”
Not true. There are certain criteria to enter into the trials. They are limited to a select group.
Stop_Moaning Says:
“Besides there are several other drugs coming up for regulatory approval in refractory prostate cancer soon. Some have far better results than Provenge.”
Great, but right now there are no other choices.
A dying person cannot “wait” for other alternatives. And once these alternatives to Provenge come out then there will be choices and if Provenge is deemed inferior then it can be taken off the market.
I agree that the FDA cannot let just any drug on the market. If it is a “non-lifesaving” drug like a sleep aid or sexual aid etc then it by all means better be deemed not only 99% safe but also very effective. And the FDA should take its time in making the decision on such types of drugs because life or death does not become the outcome of the decision.
Stop_Moaning Says:
“Don’t forget Provenge did not hit its primary targets in either phase III trial.”
Irrelevant, Provenge had better results than meeting those endpoints; provenge prove to extend life. This trumps all in my opinion (and those of the dying I am sure)
If you walk up to a swimming pool and see a man drowning, you have a choice:
1)throw him your man made life ring that you have with you
or
2)wait for a Coast Gaurd approved Life ring that is on its way.
Which would you do? We know what the FDA would do.
May 29, 2007 at 7:26 am
You obviously have little experience with biotechnology. The FDA has hordes of these companies that bring that products up for BLA/NDA approval. The FDA does not and should not lower its standards for ANY product. Provenge is not proven to extend lives, it just appears that the data from two small trials demonstrates this. It must be proven. Period. Again as I wrote before, I think you and many others on this blog are rookie biotech investors that took your first FDA slam loss. Next time do your homework and learn to read the market. The “answer” was in the volume when the price surged to $25 and then in 10 minutes dropped to $21. Someone knew what was coming. If they were to receive approval the FDA would have been working with Dendreon on labeling issues for the new drug. Obviously this did not happen and alarm bells went off. Also the CEO selling a load at $13 was a serious red flag that all was not well in DNDN land.
Lick your wounds, learn from your mistakes and do better next time.
Prostrate cancer patients will not suffer if this turns out to be snakeoil. Also, Provenge will be available to those who ask for it. Have you ever heard of compassionate use? This is of course up to DNDN, if they refuse compassionate use, then you know what they are all about, money and nothing more.
Only safe and effective drugs should go to market. Period.
Thanks FDA for not bending to pressure from losing Biotech investors. Kudos to Dick Pazdur !!!
May 29, 2007 at 9:55 pm
The Provenge CR letter makes me worry that the “Chemo Cartel” has bought the FDA and that terminal patients have been relegated to afterthoughts.
June 3, 2007 at 11:26 pm
Why doesn’t DNDN get the drug approved outside the US. This has been done before. Then patients would have access and the FDA would have to capitulate.
Just a thought.
June 6, 2007 at 8:49 am
It is one thing to read the transcript but to watch it is beyond words.. you must watch it. go to IV and ask for link..How in Gods name can the FDA delay this drug…after watching the vidio…..May God have no mercy for Dr V E , DR.Hussein. Dr Sheir, as they have no mercy for the PC patients……that are dieing every day….You must watch and ask your self what is the FDA doing….
June 6, 2007 at 10:22 pm
You can find the Video of the 3/29 AC meeting at my blog in the Video section.
Just click my username cliffhucker above.
July 6, 2007 at 11:01 am
In your rush to have a drug approved, remember vioxx and phen-phen. I’m not sure I actually have the correct web-site of the person in Alabama, but if it is, he has a conflict of interest for the drug to be approved since he’s an investor in the biotech company that created the drug.