CareToLive Provenge Prostate Cancer Petition at FDA 620 Days

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At the FDA April 16, 2008

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sourced by RoryKearney

FDA IGNORES PATIENT'S RIGHTS - They prefer to burn us, poison us and mutilate us, as if we are experimental mammals that they can torture for their own financial enrichment.

1 in 6 men will be diagnosed with prostate cancer in their lifetime. When is the FDA going to allow men with prostate cancer who are out of options, access to Dendreon's Provenge, a safe, non toxic, non invasive immunotherapy that showed 20% survival in the sickest of men. Imagine what it could do in men who are not in late stage.

The FDA has delayed Provenge approval for almost 2 years now, despite an overwhelmingly postitive FDA Advisory Committee vote of 17-0 safe and 13-4 substantial evidence of efficacy, and  an interim look 6 months ago at the "additional data" that they seek, which showed a 20% survival benefit.

Dendreon's (DNDN) Provenge final results will be disclosed by the end of April. Already Forbes' Matt Herper has published an article quoting for "statisticians" saying that Dendreon should have have disclosed that it showed 20% survival at the interim peek. Why wouldn't grown men and women want to shout it from the rooftops "PROVENGE HELPS MEN WITH PROSTATE CANCER". No. They want it delayed again. Unconscionable.

They said that the it could have compromised the trial. How so I ask? How could that change the results of 3 infusions years ago. Are they setting us up again? The media has distorted Provenge for years. Cramer trashed us continually, once even publicly apologizing for lying about Provenge on his Mad Monkey show. Herper pulled this nonsense time and again, see my blog >>To Catch A Rat — Illegal Rumor Mongering at its Lousiest

SEC Here is Herper's Hatchet Job on Dendreon's Provenge Prostate Cancer Immunotherapy which was published in Forbes on September 15. http://www.forbes.com/healthcare/forbes/2008/0915/070.html #13Scroll down for updatesMatt, You Didn't. You called Provenge LOUSY! You did!... opinion by RoryKearney | 30 wks ago | updated 30 wks ago
1617 views | 2 recommendations | 2 comments

Herper interviewed me at a New York rally for Provenge outside Memorial Sloan Kettering.I also spoke to him at our large rally outside the FDA in 2007. He never published a word I said. After all, it doesn't suit Matt's agenda, which is to trash Provenge using his bully press pulpit.

And here is Cramer's history of trashing Provenge

http://my.nowpublic.com/tech-biz/loathe-jim-cramer-or-love-him-you-now-subsidize-his-salary

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The FDA is a corrupt organization who cares little for the health and well being of the United States Citizens. Wall Street, Pharmaceutical profits, and conflicted FDA officials, who like to keep things the status quo.

Does the FDA care about us. Not one jot! They allow us to talk to Paul Richards, from FDA Public Affairs. That's it. That is our recourse. There is nothing public about him. His job is to defend the FDA no matter what. He is the liason between the 60,000 men who have died of prostate cancer in the past two years, and our petition asking the FDA to review the Provenge delay. He could care less what you say, and will defend the FDA no matter what. His job is not to reveal anything.

Public Relations my arse.

If you want to waste your time, give him a call. Paul Richards - 1-800-835-4709 or 301-827-2000.  Ask him why our petition is languishing unanswered.

Paul Richards won't even answer the question which nobody disputes. Is Provenge safe? He says he attended the Advisory Committee meeting the FDA convened to discuss Provenge, but he won't even admit that the regulatory question about efficacy was bastardized (we believe by Richard Pazdur of CDER), and fortunately was changed back during the vote to the correct question by Jesse Goodman, former head of CBER. He acts like they cut us a break by changing it back to the standard regulatory wording.

It must be nice working for the FDA. Union you know. We pay their salaries and some of the top echelon there  are the worst of the worst bureaucrats ever to hold a regulatory position. They completely ignore us. We, and our children, pay their pensions and their health benefits and their cushy vacations and personal days and accrued sick days. Is it any wonder Paul Richards says "it is great working at the FDA".

One of the days we protested there, I noticed women walking in wearing 3 inch spike heels dressed like fashionistas. It must be nice. I know there are a lot of good, dedicated people at the FDA. We need them ALL to fit that bill. We need them to allow us access to better, safer, more humane treatments NOW!

The first immunotherapy for cancer was approved in April 2008 in Russia. It is an American company, Antigenics Oncophage that did not meet the stringent maze the FDA has you trapped in, and rather than either go bankrupt or sold to one of the pharmaceutical giants who may have thrown the treatment in the trash, to keep the chemotherapy, radiation, healthcare cartel humming, they applied in Russia and got approved.

Provenge could have been first cancer immunotherapy approved had the FDA approved it 2 years ago as it should have. It has showed stellar results for a cancer treatment.

Two conflicted panelists who Pazdur pushed into the meeting, with ties (disclosed and undisclosed) to the chemotherapy industry and competitiors, cried at the meeting that they need more data to prove the survival benefit, which they clearly saw, was due to Provenge. At the interim peek 6 months ago, Provenge showed it prolonged survival among 20% of the men with prostate cancer, a 2% miss, in the sickest of all patients. The FDA made them continue gathering more data, instead of approving it on the spot, since it is very safe, and showed supporting evidence. Isn't prolonging 5000 men's lives statistically important?

There are men living over 7 years since they received the 3 infusions of Provenge. The FDA needs to be completely overhauled.

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Don't miss this article

"FDA Staffers Demand Management Housecleaning"

Excerpts

Nine physicians and scientists at the Food and Drug Administration have called on the Obama administration to remove career civil servants from top jobs at the agency because they caved into political and corporate pressure during the Bush years.

FDA managers who have failed to protect the American public, who have violated laws, rules, and regulations, who have suppressed or altered scientific or technological findings and conclusions, who have abused their power and authority, and who have engaged in illegal retaliation against those who speak out, have not been held accountable and remain in place," the letter said.

Continue reading:  http://www.gooznews.com/archives/001371.html

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or this

The Five Dumbest Product Bans, 2009
An Annual Review of Regulatory Absurdity

By Eli Lehrer, 4/3/2009 10:59:03 AM

http://www.hawaiireporter.com/story.aspx?7070255f-67df-40c5-af64-9b4fc952db1e

They are as follows:

*1) Using the Cancer Drug Provenge (National).

Provenge, a prostate cancer drug, has shown good results in clinical trials. It could represent a breakthrough in the treatment of end-stage prostate cancer. Unlike most cancer treatments, many of which have serious side effects, Provenge acts like a vaccine by stimulating patients’ own immune systems to fight off cancerous cells. In clinical trials, it extended patients’ life by a median time of 4.5 months—twice as long as the only other comparable prostate cancer therapy. After three years, over a third of those taking

Provenge remained alive, compared to barely more than one-10th of those receiving placebo. In 2007, the Food and Drug Administration’s (FDA) scientific advisors unanimously agreed that the drug was safe enough for approval, and voted 13–to-four that it was effective enough.

Nevertheless, in 2007, the agency decided to keep the drug off the market until the manufacturer could complete more clinical trials, a process that will last at least through the end of 2009, even though there is no evidence that approval would cause significant harm.

Clinical tests of the drug showed that:

Treatment with Provenge was generally well tolerated. In controlled clinical trials, the most common adverse reactions associated with Provenge were chills, fever, headache, fatigue, shortness of breath, vomiting and tremor. These events were primarily low grade events, with a short duration lasting 1 to 2 days following infusion.4 For a product intended to treat end-stage prostate cancer, such side effects are remarkably mild. As the editors of the journal Nature Biotechnology note, the only other approved drug for the treatment of end-stage prostate cancer, Taxotere, is less effective and “is so toxic it kills 300 patients itself every year.”5 Delaying approval of Provenge will cost lives. The FDA should approve it immediately.

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Ted Girgus has been waiting 2 years. His prostate cancer has metastacized to his bones. His doctor wants him on Provenge NOW!

View Ted's video here >> http://youtube.com/watch?v=6Q0uQAL_YDA

We ran this ad in April of 2008 in the Rockville Gazette in Rockville, Maryland, the FDA's backyard.

Men need Provenge approved NOW!

(click to enlarge)

Here is the CareToLive Petition we filed in July 2007. The FDA still refuses to give us an answer while men like Ted Girgus are dying for Provenge. The FDA is a totally insensitive, dysfunctional organization without a care for the lives of our citizens.

Request to FDA to Reconsider the Failure to Approve Provenge - Docket 2007P-0297

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Here is a universal letter we wrote that you can personalize and send out to our Congressmen.

To find your elected officials http://www.conservativeusa.org/mega-cong.htm
  Your Name
Your Street
Your City, State & Zip Code
your e-mail@address.net


April 6, 2009


Dear         ,

I would like to alert you to the serious need to keep your eyes on a cancer treatment that is currently making its way through the FDA approval process, for the second time in two years. The reason this approval process needs watching is because several conflicted people interfered with that process the first time around, and it appears they are already interfering again.
http://www.forbes.com/2009/03/24/dendreon-provenge-business-healthcare-dendreon.html?partner=yahootix 1 in 6 men will be diagnosed with prostate cancer in their lifetime. Every year 220,000 men in America will be diagnosed with it, 96,000 of them will advance to late stage, and 30,000 of them will go on to die from it.

The FDA called for an Advisory Committee during the approval process for this treatment, Dendreon's Provenge, in March of 2007. It is a safe, non-toxic, non-invasive immunotherapy, which strengthens one's own immune system to fight the cancer. The FDA granted Provenge Fast Track Status and Priority Review because it showed a survival benefit for terminally ill patients, who have no other option.

Before the panel even sat down at the hearing in 2007, two conflicted doctors, one of whom was leading a competitive Phase III trial and working for an investment firm heavily invested in that competitor, was  allowed on the panel.

Before the panel even sat down, the Congressional regulatory efficacy question, had already been tampered with.

The committee studied the briefing documents prior to the hearing, came and heard the Provenge presentation, raised questions and concerns, and then voted on the two questions.

Is Provenge safe? The panel voted yes, 17-0.

Does Provenge show substantial evidence of efficacy? The panel voted yes, 13-4.

Needless to say, patients and their doctors who were waiting for approval, were very happy that Provenge received such a strong endorsement at the hearing. These men are fighting a lethal disease for which no other viable treatment options are available to them.

After the hearing, the two previously mentioned conflicted doctors, wrote letters to the FDA telling the FDA not to approve Dendreon. A third doctor also wrote a letter. Someone from inside the FDA leaked these letters to the public to give the appearance there was something wrong with Provenge. Much hoopla was made in the press disparaging Provenge. The result was that the FDA delayed approving Provenge to the men and asked for additional data. Grown men were left crying and asking why.

This April, Dendreon will have the additional data the FDA is asking for. Already, negative reports are appearing in the media, trying to once again give the public the appearance that there is something wrong with Provenge.

One such media outlet is Forbes Magazine. The “reporter”, Matthew Herper, also promoted the leaking of the letters in 2007, one of which was written by Thomas Fleming. Mr. Herper called Dr. Fleming’s letter the most compelling.

This past September, Mr. Herper wrote another article in Forbes, stating the data for Provenge were lousy and he cited Thomas Fleming as an expert well-respected in his field.

Recently, on March 24th, Mr. Herper wrote another article citing Thomas Fleming and three other statisticians, two of whom are Thomas Fleming’s colleagues, one cowrote a book with him, another is cited in the book, stating Dendreon may have endangered its own trial.

Dendreon was asked about the Forbes article and this was their response: “Yes, we saw the Forbes article. It seems surprising that this story has surfaced nearly six months after we announced the data from our interim analysis. As you know, the endpoint of the IMPACT study is survival, and obviously, this is an endpoint that cannot be biased. All of the patients had been enrolled and treated at the time of the interim analysis, so Dendreon believes that the integrity of the trial will not be compromised by our learning the hazard ratio from the Independent Data Monitoring Committee (IDMC) at the time of the interim analysis. The FDA agreed to allow this (per the SPA), for the reasons that I stated above.”

It certainly appears that Mr. Herper and Dr. Fleming are once again colluding to stop a safe, effective treatment from reaching the men. I suspect they are working with a select few inside the FDA. Take notice of what Mr. Herper wrote back in 2007 when Provenge was being considered by the FDA:

"But right now, its stock is dangerous to buy, because its fate will be determined by unpredictable politics at the Food and Drug Administration, not the certainties of science."
 
http://www.forbes.com/2007/04/20/prostate-dendreon-stock-biz-cx_mh_0420dendreon.html

How did Mr. Herper know there were politics going on inside the FDA?

Why is Mr. Herper trying to make it look like something is scientifically wrong with Provenge?

Why didn’t Mr. Herper, as any good reporter would, investigate and expose this political interference that he claimed is going on with the FDA approval process?

I ask you, as my representative in Congress, to call for an investigation into what went wrong with the Provenge approval the first time around, and to please watch as the confirmatory data is released this month, (the data has already showed 20% survival in an interim peek), and make sure that this time the FDA bases its decision on the science, taking into consideration compassion for the desperate men in need of Provenge now, instead of basing their decision on politics and conflicts within the agency, as well as with pharmaceutical ties, and investment interests, they have outside of the agency.

The first imunotherapy for cancer, Antigenic's Oncophage, has already been approved for a cancer treatment by Russia. Sadly, that distinction could have gone to the United States had the FDA approved Provenge in 2007, as it should have. The company that received the Russian approval is an American company, that left the United States when the FDA put up insurmountable obstacles for it to be approved here, and rather than face bankruptcy, by years and years of FDA delaying tactics as they tried to comply, they submitted it in Russia instead. The obvious benefit of the treatment won them approval.

Provenge approval could fundamentally change the way that prostate cancer, and other types of cancer are treated. America could get back to being the world leader in health care advancement. The FDA needs to embrace the newer, better, more humane treatments instead of sticking with the current toxic, harsh treatments that are the status quo. Better, safer medicine should not be a battleground. It is something we should all embrace and celebrate. Please help see that Provenge is approved this time around.  Thank you for your attention to this matter.
Respectfully,  http://www.investorvillage.com/index.asp

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We are still waiting for the FDA to release some of the Freedom of Information (FOIA) documents we requested.

Transparency my arse.

More Prostate Cancer Smoke & Mirrors From the Broken FDA

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Ya see, a big hedge fund (was it Stevie Cohen's SAC Capital?) whispered in CNBC's Mike Huckman's ear years and years ago, "it doensn't work", and they all piled on and shorted the stock to the bone. Since then, it has been trash and slash for fun and profit.

3/22/07 Mike Huckman wrote

"I remember sitting at a table at a rare Dendreon analyst meeting a few years ago and someone from a Connecticut hedge fund leaned over and whispered in my ear "It (Provenge) doesn't work."http://www1.investorvillage.com/smbd.asp?mb=971&mn=50231&pt=msg&mid=1729997

Now how would he know that? Where is the Congressional investigation. Too busy holding hearing for baseball and steroids and Basketball to worry about real men who are dying of real painful cancers.

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Provenge is just the tip of the iceberg. Dendreon has a pipeline of immunotherapies waiting for the green light. Whether you buy in, or not, please join us in our fight to bring better, safer, more humane cancer treatments to the world.

http://dendreon.com/pipeline/  
PROMISING NEW CANCER THERAPIES ON THE HORIZON

Dendreon is focused on discovering, developing and commercializing novel therapeutics to fight cancer. Our pipeline includes active cellular immunotherapy, monoclonal antibody and small molecule product candidates to treat a wide range of cancers.

The dedication of our research and development team has resulted in our lead product candidate, sipuleucel-T, rapidly approaching commercialization.

Sipuleucel-T, an active cellular immunotherapy, is in late-stage development for the treatment of metastatic, androgen-independent prostate cancer.

Lapuleucel-T, an active cellular immunotherapy, is in development for breast, ovarian and colon cancer.

CEA, an active cellular immunotherapy, is in preclinical development for breast, lung and colon cancer.

CA-9, an active cellular immunotherapy, is in preclinical development for kidney, colon and cervical cancer.

Trp-p8 (also known as Trp-M8), a small molecule, is in preclinical development for prostate cancer. 
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