Dendreon Provenge Immunotherapy

"Why The New Dendreon Analysis Does Matter — And Why It Doesn’t"

2011-02-19T17:45:00.000-08:00

"Last night, a researcher from Duke University presented an analysis that may help cement the case that Dendreon’s Provenge extends the lives of men with metastatic prostate cancer – if, that is, you think additional proof is needed."

Read more here

2009-04-14T19:35:00.000-07:00

Dendreon: The Revenge of Provenge
by: David Miller

DENDREON Scores a TOUCHDOWN with PROVENGE

by: Rory Kearney

Dendreon's Prostate Vaccine Boosts Survival

Dendreon's controversial Provenge cancer vaccine may get another chance two years after the FDA rejected it. The drugmaker's stock soared on the news

2008-06-12T11:58:00.000-07:00

Dendreon's Provenge: Government Agencies Play Hide and Seek With Facts

2008-06-02T08:12:00.000-07:00

Denial is a River of Blood at the FDA

Read all about it at CareToLive.Com

Howard scher reward

2008-05-31T14:34:00.000-07:00

There is an ongoing (and growing) reward to anybody that can show proof that Howard Scher or Maha Hussain were ever really threatened as they claim.

See here for informaton. here, here.

"The proof must be submitted to a neutral third party who I have retained and must document an actual report filed with the authorities between March 27, 2007 and the June, 2007 cancer symposium at which private protective services were retained to protect the two individuals involved."

War

It is clearly evident that they have tried to turn the public eye from the real issues here. I even had interviews with Bob Stein of the Washington Post and all he cared about was a story on how the life's of these 2 doctors were (allegedly) threatened.

I could find no police reports or any proof myself. So if Scher had threats, why did he not report it to the police but he did let it get out to the news? Ther is only one reason for this, and it is to get there propaganda machine going to redirect the focus of the crimes they have committed by nefariously sideling Provenge.

The same goes for the leaked letters to the Cancer rag "The Cancer Letter" that both Maha and Scher supposedly wrote that were meant for the FDA but somehow were published in the Cancer Letter. They were meant to help the propaganda machine to detract from the fact that Provenge was deemed safe and affactive by the same panel these "sick" "doctors" sat on.

2008-05-29T17:52:00.000-07:00

Dendreon Revisited

2008-05-29T02:01:00.000-07:00

2008-05-22T10:30:00.000-07:00

"Cancer's Cruel Economics"

"Fast tracking Cancer Drugs"
http://www.cbsnews.com/sections/i_video/main500251.shtml?channel=/sections/eveningnews/videoplayer3420.shtml

2008-05-11T11:35:00.000-07:00

"Real FDA Commissioner Needed"

"Coast to Coast Prostate Cancer demonstrations"

2008-05-07T07:30:00.000-07:00

"Dendreon: The Provenge Approval Scandal, One Year Later"

http://seekingalpha.com/

2008-04-23T09:19:00.000-07:00

ahh, duh, my name is Andy.

Quote Of The Week: Skinning An FDA Commish
“I didn’t fall off the cabbage wagon yesterday. I’ve been talking to food and drug commissioners for 40 years. And you’re not the first fella I’ve had to skin for not doing his job and coming up here and defending an indefensible situation..." Dingell

2008-04-21T12:29:00.000-07:00

Dendreon: The FDA's Commissioner Doth Protest Too Much!

2008-04-15T08:53:00.000-07:00

We’re Going Back To The FDA Tomorrow Wednesday 4/16/08

This is Week #3 of our “In Your Face” Rockville Gazette Advertising Campaign to raise awareness to the tragedy that is taking place in the prostate cancer community. While 83 men die every day of prostate cancer, the FDA sits on our Petition, and refuses to reverse their fatal decision to delay Provenge to the 30,000 men who might have benefitted from it, each year.

We will be there at 7AM. Join us!

Howard Scher is a slime ball.imo

2008-04-09T23:50:00.001-07:00

"A Bitter Irony In The Provenge Saga"

At the heart of the controversy over the Provenge prostate-cancer vaccine, which an FDA panel last year recommended before the agency delayed approval, are allegations of undisclosed conflicts of interest involving two of those panel members.read more here:

2008-04-09T07:25:00.000-07:00

CareToLive Continues Its “In Your Face” Ad Campaign Asking the FDA to Approve Provenge for Prostate Cancer NOW!

2008-01-30T20:13:00.000-08:00

Provenge: Setback In Congress, Progress In The Lab

FDA Commish On Provenge: What Letters?

2008-01-08T21:35:00.000-08:00

THE ROAD TOWARDS PROVENGE APPROVAL IN 2008
By: Thomas A. Farrington
President and Founder
PHEN

Bush's FDA - Perpetual Leaker of Insider Information

2007-12-19T12:49:00.000-08:00

Three Lawmakers Give Terminal Cancer Patients Early Xmas Gift

Digg it

2007-12-18T10:28:00.000-08:00

Dr. Chuck Bennett: Corruption means more suffer with prostate cancer

2007-12-13T10:22:00.000-08:00

Congressmen Call For Probe Into The FDA, Provenge And Conflicts Of Interest

2007-11-27T12:29:00.000-08:00

FDA's Refusal to Approve New Cancer Vaccine - The Plot Thickens - Part I

2007-11-05T05:39:00.001-08:00

GET ON THE BUS GUS!

Provenge Rival Hits A Brick Wall And Stock Dives

2007-10-10T00:18:00.000-07:00

Fight Over Cancer Drug Gets Ugly

Drug review drag

Gregory Conko
October 10, 2007

"For terminally ill patients who depend upon new drugs making it to market quickly, this law may be a death sentence. People like Bruce Towers don't have time to spare."

2007-10-09T05:33:00.000-07:00

FDA Industry Insiders Derail Approval of New Cancer Treatments

It’s A Small Prostate-Cancer World, After All

2007-09-18T15:48:00.000-07:00

FDA Officials Sued Over Conflicts of Interests Part I

Part II

Protesters demand new cancer drugs

U.S. cancer patients rally for Dendreon, other drug

2007-09-13T06:59:00.000-07:00

"Should terminal patients have access to promising therapies?"

Hopefully this video will be used/addressed in the CNN You Tube Republican Debate.

The more people that can "rate" the You Tube video, the better the chance that it will be used in the debate.

Just click the 5th Star to rate the video. You can also leave a comment. You have to register (free) with you tube to do this, but it is very simple. Just click the "log in to rate this" link next to the stars.

2007-08-21T12:12:00.000-07:00

Hypocrite? Coward? Liar?

Patient Power:
Prostate Cancer: Fighting the FDA for your Life
Radio Show

FDA Debate: Is Agency Really Doing Its Job?

Life, Liberty and the Access to Promising Investigational Drug

"Life-Saving Cancer Drugs rejected By FDA"

What You Can Do to Stop Needless Cancer Deaths

From Clinical Cancer Research: Rethinking Therapeutic Cancer Vaccine Trials

2007-08-20T01:11:00.000-07:00

The FDA and Howard Scher are being
sued over Provenge's NON-Approval

FDA Sued for Withholding Cancer Treatment

DNDN's Provenge: In FDA Spotlight, CNBC

The filed Lawsuit (link to lawsuit)

Provenge Group Files Lawsuit Against FDA by:Pharmalot

FDA News

Pressure for Provenge Approval

Dying Patients Fight the FDA

FDA sued over Provenge delay

"The FDA's Deadly Track Record"

Turning Up the Heat (Again) on the FDA

Provenge Lawsuits May Be A Sideshow, But Cancer Patients Should Keep Fighting

2007-08-16T23:48:00.000-07:00

FDA Sued for Withholding Cancer Treatment

My Evolving Views on the Provenge Story

Provenge: The Battle for a New Prostate Cancer Treatment 8/7/07

Court denies terminally ill experimental meds 8/7

Poll: Did the court make the right decision?

A fight to give hope to the terminally ill

Biotechs Challenge
FDA Approval Process;

Dying? Tough Luck

Cancer Cure Coalition Protests the Federal Court's Ruling Against the Abigail Alliance

The grim regulator
Feds keep punishing terminal patients

"The New Right to Life"

No Experimental Meds For The Terminally Ill 8/8/07

FDA Receives Assurances That PDUFA Remains Priority on Capitol Hill

The FDA and Life Saving Drugs - Redux

"DYSFUNCTION AT THE FDA"
(from page B4 of the Washington Post 7/15/07)

"Cancer Regression"

"In recent years, the FDA has effectively regressed to a pre-AIDS mindset. The accelerated approval requirements have stiffened and the real benefits of the process for patients have been whittled away."
By RICHARD MILLER

The cancer industry remains ignorant of useful treatments 8/7/07

The end-point of survival is what counts to advanced prostate patients and their families! Nothing more.

HOT NEWS
"Dendreon, Provenge And Conflicts Of Interest"

FDA Panels Would End Conflicts Of Interest, According To House Proposal 8/7

FDA Receives Assurances That PDUFA Remains Priority on Capitol Hill

"FDA Builds a Bridge to Afterlife"
"Isn’t it interesting that AIDS, which is a new disease compared to prostate cancer has many drugs and treatment options, while prostate cancer victims have only one drug…Taxotere.
Can you say monopoly?"

"Hey, Hey, FDA, How Many Dads Did You Kill Today?"

FDA Delays Cancer Treatment -
Money, Power & Greed?

"FDA tyranny to become law"
".House of Representatives, much like the Senate, is utterly controlled by Big Pharma and has abandoned any responsibility to defend the interests of the voters. Drug companies now have complete control over the U.S."

"it may be time we focus less on statistical significance alone,
and more on patient benefit."
Howard I. Scher , MD

Scientists at the National Cancer Institute found evidence that therapeutic cancer vaccines, including
Dendreon's Provenge, were "prolonging patient survival."

"Imagine calling a clinical study a failure because the tumor size did not significantly decrease, yet the average survival rate of patients increased! Is it not the survival of patients the real aim of medical treatment? Provenge deserves a second hard look by the FDA,"

China executes top FDA official while the U.S. does nothing to counter corruption

"Provenge, FDA Panels And
Conflicts Of Interest"

"The FDA agenda is favorable to Big Pharma and the sickness industry,"
"It is harmful to the personal health and health options of Americans."

“Power To The Patients”

Commissioner Andrew von Eschenbach
Does he NOT Want : Dying Prostate Cancer patients to have the Provenge choice !?

Dr. Richard Pazdur
Does he NOT Want : Dying Prostate Cancer patients to have the Provenge choice!?

"The Division's mission is to ensure that new cancer drugs are as safe and effective as possible and to facilitate access to promising therapies for seriously ill and dying patients when no other treatment is available."

"Pazdur's Revenge"

"Pazdur's Cancer Rules"

"Drug Czars"

Who Represents the People? Industry Influence and Organized Advocacy

Dr. Howard Scher
Does he NOT Want : Dying Prostate Cancer patients to have the Provenge choice!?

Schers Alleged Undisclosed COI's
(Conflicts of Interest)

Biotech In The News

"When Howard’s drug is concerned, he sure seems to want to loosen things up, eh? But when a rival therapy, which has the potential to set the chemotherapy establishment on its rear end, and which even he acknowledges is perfectly safe, is being considered, its time to violate protocol and write letters to the FDA to ensure its denial."

Dr. Maha Hussain
Does she NOT Want : Dying Prostate Cancer patients to have the Provenge choice!?

What about You Mr. Milken?
Would you like to see Dying Prostate Cancer Patients
have the Provenge Choice?

Where are You?

"Power to the Patients" ?
Gary S. Becker, Ph.D.
FasterCures Board Member
"Giving people whose lives are threatened by serious diseases greater access to safe, promising (albeit unproven) drugs and other treatments would help their psychological state. More important, it would lower the cost and hasten the development of therapies that could really make a difference."

"As I started digging into the story, little did I know that I would find such manure, politics, and corruption. I found an insidious Cancer within the FDA that is multiplying itself, driving promising treatments to extinction. This Cancer is life-threatening to not only to Dendreon, but to many other enterprises with promising new treatment options."
Karuna Kanagaratnam

2007-06-15T23:51:00.000-07:00

This Man Credits Provenge
For His Life!

This man also Credits Provenge
For New Life

" Two years after receiving Provenge, doctors say the swelling in his lymph nodes and his PSA cancer markers are down. He says, "I feel like I have a new lease on life."

"So Bruce joined 250 other “guinea pigs” for an experiment called the Provenge Trial.
During that trial, he received his harvested dendritic immune cells, which were manipulated in a lab with prostate protein molecules and then infused back into his body as a new prostate cancer immune cell.
The drug paid off."

Dr Moyad At DC Rally 6/4

Panel Recommends FDA Approve Prostate Cancer 'Vaccine'

Federal Court Approves Experimental
Drugs for Dying Patients

Should dying patients have access to experimental drugs?

"I'd like to ask you all to close your eyes for a moment because I want to paint you a picture" Jan Manarite

"VonE thinks he has you all fooled."
"VonE could have just been an evil murderer, full of greed, and still been true to himself by not performing these elaborate gymnastics, which we all know are lies anyway. Instead he is this evil man, but a pathetic coward as well."
Full Story Here

The Boston Globe Article 6/18/07

&
Response to Globe Article
(by ; nmstav)

"What about the "Endpoint" of LIFE"
My father has been diagnosed with late stage prostate cancer that has spread throughout his body. We have been informed by his urologist, Dr. Jacobsen (Austin, TX), that he will be gone in 12-18 months with traditional therapies...

A Must Read
"Cancer vaccines and immunotherapy are ready to move beyond proof of concept studies, and we are ready to move them to the patients as safe and effective treatments for cancer."
Andrew von Eschenbach

The FDA is protecting guys who are GOING TO THEIR GRAVES from WHAT?? Flu-like symptoms?!?!?!?!?

Dendreon (DNDN), Provenge and the FDA
"FDA and how it makes decisions. Poorly, is the simple answer. The agency is using 19th-century scientific logic to manage the process of approving or rejecting 21st-century drugs."

Dear Senator Kennedy

2007-06-05T12:53:00.001-07:00

How can the FDA allow the lead investigator on a competing drug sit on a panel to judge Provenge ?

COI = Conflicts of Interest

FDA Conflicts of Interest. Click to view full cartoon.

"FDA is committed to strictly adhering to the laws and regulations governing the process for selecting advisory committee members."
"whether an advisory committee member has a potential conflict of interest and whether participation is appropriate"
"participation of members with potential conflicts of interest generally would occur under narrow circumstances where the potential conflict is minimal and the member's expertise is needed for the committee's deliberations."

Sandra Kweder, deputy director of the FDA Office of New Drugs, said it was not unusual for advisory panel members to be kept from participating in a meeting if they have clear financial interests or intellectual positions that could keep them from being objective.

“I try to keep to the high ground,” Scher said, adding that he doesn’t work with any companies in direct competition with Dendreon. He serves as advisor to Innovive, a small biotech not involved in prostate cancer, and works with Bristol-Myers Squibb in an unpaid capacity on early stage drugs that may hold promise in prostate cancer. He and his wife hold small amounts of stock in Biogen Idec and Pfizer, he said

IS THIS A TRANSPARENT CONFLICT OF INTEREST?

"it may be time we focus less on statistical significance alone, and more on patient benefit."
Howard I. Scher , MD

"So the first thing I want to point out, that no one disagres that survival ought to be the key fact. However, it's the spirit of how that survival has been looked at, not an after-effect, or afterthought, it's intended in the firat place to be looked at."
Maha Hussain

(Page 308) ?

So serendipitous findings such as survival extension are irrelevant because they were not specific endpoints?

A few years back while judging whether a drug for pancreatic cancer should be approved (one that was not as safe as Provenge) Dr. Maha Hussain said:"This was a positive study in a tough disease," "I don't think we ought to be the judge on what patients would choose."

5th article down page

Maha Hussain, M.D., of the University of Michigan in Ann Arbor said that even slight benefits are significant in "a tough disease."

Prostate Cancer Doctor Receives
Death Threat Over Provenge

Provenge critics receive threats

FDA Delay In Cancer Therapy Is Attacked
by: Rob Stein

Some responses to Rob Steins article:

Behind the Scenes of the Provenge

Dendreon's Provenge: Making The Right Kind of News?

Provenge, FDA Panels And Conflicts Of Interest

This was an easy story to get right and the fact the reporter didn't....

On the alleged threats made upon Doctor Scher or anyone;

Absolutely no-one should be threatening this/these Doctors. The authorities should be (and hopefully are) investigating these alleged/seemingly apparent "Conflicts of Interest". And I would hope anyone who has made threats will face the law as well.

It certainly would be nice if Americans could simply trust that our government agencies are looking out for the populace and not just a few wealthy, influential individuals. We must trust in our system for it to work. It is up to our policy makers and governmental representatives to look out for the people (all Americans) which they serve.

Is it wrong to want what is only fair and just?

I pray for those patients that are holding on for that extra day of life, searching for some faith and hope that someone will help them.

I would want the option to choose the fate of my health; I would choose to take Provenge. What other options are there? It is hard for the healthy to realize that a few extra years is everything to someone who can see his demise within the pages of a calendar.

Cliff Hucker

Letter to SEC

By: Phaider

Letter to Pollack

Scandal To Say The Least

2007-06-04T00:55:00.000-07:00

Is Andrew von Eschenbach/FDA One Huge COI ?

FDA is Becoming a Drug Company

Andrew von Eschenbach has Strong Ties to Big Pharma, Wall Street

FDA Plagued by Problems, Overtaken by Politics

Americans fed up with drug industry influence, FDA corruption

FDA shielding Big Pharma

How the FDA Protects Big Pharma

FDA and USDA are highly corrupt to protect profits, not people

How the hell did Scher & Hussain make it through this algorithm????????

Emoluments Clause of the U. S. Constitution

Ethics for SGE's(pdf)

Draft Guidance on Disclosure of Conflicts of Interest

2007-06-02T15:26:00.000-07:00

"Denial of approval for Provenge is a classic example of this problem, where an agency that was established to protect the public from dangerous and/or useless substances is instead taking on the role of dictating to dying patients and their families what they will and especially will not be given access to solely on the basis of cold statistical fine points, even when one is dealing with advanced malignancies wherein the lethal clinical outcome of placebo treatment in clinical trials or of standard therapy is known with near certainty. This is simply cruel, and as a physician I think that it is insupportable."

"I am not aware of a decision to overrule a strong positive panel vote for a terminal illness that has no really acceptable treatment options. This decision would appear to be unprecedented, and calls for a full and open public statement of why the FDA disagrees with this panel and cannot make this drug available to terminal patients. We know of course it was not due to safety concerns. Also, if FDA found the clinical trial data submitted by Dendreon to be insufficient, why did you even submit the data to a panel of experts for their opinions?"

"Personally, I can only hope that the FDA approves Provenge so that patients, with the consultation of their doctors, will have the freedom to control their own bodies and make their own, informed decisions.

We are intelligent adults; we can understand the risks and the rewards. Let us make our own decisions." Joel T. Nowak, MA, MSW & Here

Is The FDA "inhumane" ?

2007-05-25T14:34:00.000-07:00

“We believe that the FDA’s decision to delay approving a safe, effective treatment for prostate cancer patients is inhumane,” said Thomas Farrington, charter member of ProvengeNow and founder and president of PHEN. “Furthermore, we are saddened and concerned the FDA has blatantly ignored – not only its own advisory panel of experts – but the voices of the patients. We urge them to approve Provenge immediately to give patients this treatment option.”

Thomas A. Farrington letter to FDA 3/26/07

The FDA Turns Its Back on Black Men

"There are so many unanswered questions and a great deal of controversy surrounding Provenge, I don't know what to think any more. Advanced prostate cancer patients should have an opportunity to utilize the treatment, if they so desire. They and their doctors should be given any and all treatment options to fight this war on cancer. I am baffled as to why this is so difficult to accomplish. Currently, the only available treatment for advanced prostate cancer is chemotherapy, which most men refuse, due to the dreadful side effects and decreased quality of life."Melody Davis-Bennett, RN, BSN.

2007-05-25T00:29:00.000-07:00

Dendreon / Provenge in The News

Dendreon Jumps on New Cancer Vaccine Report 7/4
Reinventing the Regulation of Cancer Drugs 3/96
New Drug Becomes Option For Men With Prostate Cancer
"Uncle Sam, M.D."By SCOTT GOTTLIEB June 18, 2007
Honoring Black Men With Good Science
Prostate Cancer Breakthrough 6/6/07
A Gender Gap in Cancer 6/13/07
Oncologists make money by providing chemotherapy 6/12/07
Lance Armstrong: Patience running thin with D.C. 1/25/07
Meeting of the minds on cancer 6/07/07
Sen.Schumer Reveals: Prostate Cancer A Growing Epidemic
Why is the FDA hindering therapy for prostate cancer? 6/7/07
Big shot of cash for Dendreon6/7/07
The ASCO/Avandia Hangover 6/7/07
'We Need to Move Now' 6/5/07
Prostate Cancer Doctor Receives Death Threat Over Provenge PSA-R 6/3/07
Black Wednesday 5/14/07
FDA criticized for delay in prostate cancer drug 6/5/07
Panel Recommends FDA Approve Prostate Cancer 'Vaccine' 6/7/07
Provenge critics receive threats 6/5/07
Provenge Advocacy Hits the News 6/5/07
FDA to Accept Interim Data On Dendreon's Provenge 5/31/07
Dendritic Cell Cancer Vaccines 12/2005
Dendreon CEO Refrains From FDA Bashing 6/4/07
OHSUshows findings of immunotherapy vaccine 6/2/07
Drug protest set for June 4
Rally On Capital Hill pre 6/4/07
Cancer Experts Threatened After Opposing Drug 6/4/07
Analysts Continue to Dump on Dendreon 6/3/07
Hey, Hey, FDA, How Many Dads Did You Kill Today? 6/3/07
ASCO: Agents Emerging for Hormone-Refractory Prostate Cancer 6/2/07
Archaic FDA Promises 'New Era' 5/11/07
Dendreon Announces FDA Confirms Data Required for Provenge 5/31/07
Dendreon: Are the Provenge Prayers Being Answered? 5/21
Dendreon Disapproval: FDA Builds a Bridge to Afterlife 5/29
Unprecendented: Fight for Immediate FDA Approval 5/23
FDA failure to approve Provenge indicative of agency paralysis?5/13
FDA policy and guidelines dated May 15, 2007 (pdf)
New Drug Becomes Option For Men With Prostate Cancer 5/27
Dendreon Announces Presentation of Data at American Urological Association Annual Meeting 5/20/07
What is going on W/ Provenge vac.?!" Mark Moyad MD,5/07 (pdf)
Journalistic Malpractice
Pharmacyclics CEO Puts FDA Beef in Writing
Prostate cancer breakthrough 5/30/07
Dendreon: I Want the Truth 5/17/07
Cancer Experts Threatened After Opposing Drug 6/4/07

Scher/Hussain/FDA COI....News & Proof

Dr. Sher's Novacea Conflict of Interest with Dendreon

"At the advisory panel meeting on March 29th, Howard says, “investors seem to…” investors? Investors?? What do investors have to do with an advisory panel’s deliberation? Howard thinking about efficacy or investors?"
Link