01 - Terminal Patients Access to Promising Therapies

[stonerj0e]

it's kinda like if i was dying of cancer and started smoking weed, they would label me a drug addict and possibly have me thrown in jail to die with no pain meds .

this is how government works .

[1010pine]

The FDA are the REAL Terrorist! The U.S. Government is the REAL Al-Qaeda threat!

[chatykat]

Awesome!!

[achchhaa]

Best of luck to you Joel!

[diedra]

Finally - good to see this up here... now what we need is a clip of Scher's fruedin slip up on the 'investors' during the panel. PLease put that up!

[7redopal7]

I am glad that you made this video and feel that you and everyone else who has this cancer should be allowed to choose to take the new medicine if you so wish. My husband had his prostate removed in Dec'07, I know that he and I would want to do anything to prolong his life for as long as is comfortably possible. The choice should be ours not theirs.

[hjk1209]

Hey, hey, FDA, how many prostate cancer victims have you killed today?

[mariner78]

Part 7 - Finally, the delay in Provenge's approval marks a roadblock to the development of other immunotherapies. Why stop a promising technology that is probably going to be the bedrock of finally finding a way to cure this deadly killer, cancer ??

There is a pile of dirt associated with the delay in allowing Provenge to be prescribed to dying men. Where is the FDA Commissioner, Dr. Andrew von Eschenbach (himself a prostate cancer survivor), in all of this ??

[mariner78]

Part 6 -. If Provenge was approved, how many patients do you think would be volunteering for their chemo experiments ??  Dr. Scher and Dr. Hussain, after being on the losing side of the efficacy vote, subsequently wrote internal FDA memorandums outlining their objections to the Provenge data. These memos were subsequently "leaked" (or were they written to be leaked ??) to a third rate industry rag called "The Cancer Letter". Who leaked them, and why ??

[mariner78]

Part 5- The advisory committee shown in the video found Provenge to be safe by a unanimous vote and exhibiting a substantial evidence of efficacy by a vote of 13-4. The FDA has NEVER BEFORE turned down a drug recommended by it's advisory committee. So, this delay is unprecedented. FYG,two of the no votes came from Dr. Howard Scher and Dr. Maha Hussain, who have devoted substantial amounts of their careers investigating - guess what - TAXOTERE.

[rock6191]

The FDA has been turning down drugs recommended by its advisory committees for years. It only happens about 8-10% of the time, but it still happens. Also FWIW, The Cancer Letter is one of the most important oncology periodicals, especially if you're talking about inside the DC Beltway. Calling it a third-rate rag won't win you many friends on either side of the Beltway aisle.

[mhigg]

Where do you get 8-10%? I know of one other application withdrawn and none directly overturned until Provenge ... this in close to 40 AC meetings ... oh yeah, and one more recently. Ok ... that's 3 and I do see your 8-10% ... certainly a trend change in play here.

[Thurly]

If they're so reputable, why didn't they post any rebuttals to the Scher, Hussain or Fleming letters? There were several important rebuttals published elsewhere, but not published or even mentioned by The Cancer Letter. Why? I think their credibility as an objective source of information is highly suspect in this instance.

[rock6191]

I didn't say it's a reputable publication...only that it's widely read in DC circles. Calling it a third rate rag won't win over those who need to be won over.

[mariner78]

Part 4 - By deferring approval for Provenge, the FDA has condemmed men like Joel to the horrible choice of an early death or a few months more of life conferred by Taxotere combined with all the horrid side effects.

[mariner78]

P3 - The only other late stage treatment currently approved is the the chemotherapy Taxotere, which is basically derived from turpentine. Taxotere treatment side effects are so bad, and the extension of life benefit so limited, that half the end stage prostate cancer patients decide not to take it to preserve the quality of the limited amount of time they have left. Side effects include hair loss, loss of fingernails, loss of teeth, nausea, fatigue, vomiting, etc.

[rock6191]

Your conflict of interest points may be valid, but trial center investigators typically test more than one drug in their careers. Just do a Pubmed search for the lead investigator for any trial and I bet he or she is associated with a ton of other investigative treatments for the same disease. I'd direct your conflict of interest questions toward financial, rather than professional conflicts if you want to win over Congressmen or presidential candidates.

[mariner78]

Part 2 - The FDA had a golden opportunity to offer hope and extended life to patients who have no other choice. Provenge is an active immunotherapy, made by drawing the patient's own blood, isolating dendritic cells (part of the immune system), training them to identify a protein on the surface of cancerous cells and thereby activating the immune system to fight the disease. The only side effects are chills and fatigue for a few days, and most patients don't even experience these.

[mariner78]

Part I - This issue is as important as any other hot topic issue being debated in our country right now. Each year 30,000 men die from prostate cancer in the USA alone. That's 10 times more people than were murdered on 9/11. That's 10 times the number of troops killed in Iraq since the beginning of the current war. Prostate cancer is the second or third leading cause of cancer deaths.

[PCSurvivor]

Great question!! I would love to hear the answers.

[tommyfromthewho]

Delaying of the Provenge by the corrupt FDA is a travesty. FDA by this decision has condemed thousands of terminally ill PC patients to their early deaths. Shame on FDA, its leader, Von E and their corrupt employess Pazdur, Scher, Hossain and Fleming who used illegal means to delay the approval of Provenge. These men are dying silently and our representatives who are supposed to control the corrupt FDA are not even hearing their cries. Shame on the Congress for allowing this injustice to stand.

[ataloss4wds]

why should the fda play god when so many people

might benefit from this experimental treatment? let

these men make their own decisions. if this drug can prolong life for months or years; by god give it to them!

[pbrnmd]

This is a CRUCIAL health care issue for ALL cancer victims and their families. Our biotechnology research centers would be MUCH closer to curing and managing so many varieties of Cancer, but for the stonewalling and obstructionism within the FDA.

[brusky100]

Joel, God bless you. We all are trying to do all we can to help you and others. You are in our prayers.

Let's see our politicians and hopeful candidates address this issue as it deserves attention. APPROVE PROVENGE NOW!!!

Bruce E. Holmes, PE

[TahoeCliffhucker]

Best of luck to you Joel!

This is an extremely important question that demands some serious attention by our "leaders" in government.

It sounds like a no-brainer (to allow terminal patients promising drug(s)/therapies.)

I suppose the FDA does not use a human brain but a calculator to make its decisions!?

Nice work Thurly!