Ted Girgus, an energetic man who stood up and fought as hard as he could for what he believed in, lost his battle with prostate cancer on Wednesday, November 23rd.

Ted had hoped to be on Provenge way back in 2007.

Here’s Ted protesting for Provenge approval back in 2008:

http://www.youtube.com/watch?v=6Q0uQAL_YDA

Ted could have been rebuilding his immune system all these years had it not been for FDA illegally leaked letters disparaging Provenge right after the Provenge Advisory Committee voted to support approval of Provenge. The panelists voted Provenge SAFE by a count of 17 to 0 and voted Provenge showed SUBSTANTIAL EVIDENCE OF EFFICACY by a count of 13 to 4.

A severely conflicted doctor, namely, Dr. Howard Scher, working out of Sloan Kettering in New York City, spearheaded the delay on many fronts. It is Care To Live’s contention that Scher helped write a letter, along with three other doctors, on behalf of Cougar Biotechnology before the March 29, 2007 panel hearing, in which they begged the FDA not to approve Provenge. At that time Scher did not disclose that he was leading a Novacea Asentar trial and a Cougar Abiraterone trial, both products in competition with Provenge. This explains why he was so active in fighting against Provenge approval during the hearing. After the hearing he worked with Alison Martin from NCI on a letter that was illegally leaked to The Cancer Letter by the FDA. The fact that the Food and Drug Administration (FDA), the National Cancer Institute (NCI), the Department of Justice (DOJ), and Congress, all allowed this malfeasance with impunity, while lives like Ted’s were hanging in the balance, is as despicable an act as any for agencies that supposedly are serving the public.

Ted greatly appreciated Care To Live’s fight for Provenge’s approval. He and his family fought right alongside us. Ted remains forever an exemplary American citizen despite the fact that our government, paid for by his hardworking tax dollars, betrayed him.

Here is an excerpt from the last e-mail Ted wrote to CTL:

Hi Gang,

I’ve been keeping a low profile for awhile due to my new prognosis. My doctors have told me that the cancer has affected my kidneys. I’ve been told that I have about 2 months to live. I will contact the Provenge Site where I live but I think I’m past the point that they will accept me.

I want you all to know how special you have made my life and the purpose you have given me and my family.

The Scriptures tell us it’s not how we start our lives that’s important, it how we end it.

You have filled me with strength and purpose and for that I will always be grateful.

God Bless You All and I know I will see you in heaven!!!

Ted

May you rest in peace, Ted Girgus. Thanks for all you did for Care To Live. You were instrumental in the eventual approval of Provenge, and all cancer patients throughout the world owe you a debt of gratitude.

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Human Health and Resources (HHS) transparency rules differs greatly between divisions. Center for Medicaid and Medicare (CMS) has been forthcoming with our Freedom of Information (FOIA) requests, while the Food and Drug Administration (FDA) and the National Cancer Institute (NCI) continue stalling. 

Read more at Pharmalot http://www.pharmalot.com/2011/04/the-fda-conflicts-of-interest-provenge-e-mails/

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Matthew Herper, a writer for Forbes magazine and Forbes.com, has a biased, one-directional view of Dendreon’s Provenge, the first and only FDA-approved immunotherapeutic treatment for men with late stage prostate cancer. He continues to trip over his own feet in his attempts to lower the boom on Dendreon and Provenge. Over the past several years he even has attacked Care To Live, a prostate cancer patient advocacy group.

Mr. Herper could care less about the 30,000 men dying each year from an excruciatingly painful disease. He could care less about hurting a company financially that is attempting to cure not just prostate cancer, but many other forms of cancers as well. And he could care less about uncovering the malfeasance at the FDA Continue Reading Race To Undo The Cure »

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I prepared for orals expecting a lot of questions. There were not many questions asked by Judge Norris or Judge Martin but quite a few by Judge Cook. Judge Norris and Martin are a couple of salty old dogs and seem a bit more lighthearted then many of their stiffer brethren.

I had 15 minutes, 5 of which I saved for rebuttal. I presented the issue and spoke about how this case was different then most FOIA cases in that we know that there were, and maybe still are, requested documents on the computer of a single individual at the FDA.

We know this by virtue of Richard Pazdur’s admittance that he had the documents on his computer but he deleted them. So in this case the CDER division of the FDA knows where to look. Continue Reading Care To Live Attorney Kerry M. Donahue Argues for Pazdur’s Deleted Documents »

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CareToLive has been notified of its Courtroom and Judge assignment in case 09-4084 CareToLive v. FDA.

Wednesday, December 08, 2010, room 636 - 6th Floor East Courtroom, 9:00 A.M.

Before: Judge Boyce F. Martin Jr., Senior Judge Alan E. Norris and Judge Deborah L. Cook

Oral argument will be heard by this three judge panel on Wednesday, December 8, 2010 at 9:00 a.m. at the Potter Stewart U.S. Courthouse, 100 East Fifth St in Cincinnati, Ohio.

CTL’s filing in the Court of Appeals was in response to the FDA’s refusal to search Richard Pazdur’s computer or the FDA servers for documents that satisfy our FOIA request.

Dr. Pazdur had made a Declaration stating he destroyed all said documents. Kerry states, “Merely asking the fox to count the chickens, without even allowing Plaintiff-Appellant to subject the answers of the fox to any sort of test of accuracy or truthfulness, was improper.”

You can read Kerry’s fine legal filing here: ctlfoiaappellantreplyeditedii030310pdf.pdf

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Dear Colleague (ahem),

Now for the cover letter that accompanied that spurious paper.

These anonymous dolts are truly grasping at straws, alluding to fictional dreams of bloodshed and birth defects.

We are not about harming people. Au contraire. We want people to live longer with better quality of life.

If I were to mention Thalidomide, which caused birth defects in thousands of women, in the same sentence as the safe, non toxic, non invasive immunotherapy Provenge that helps men with prostate cancer add years to their lives, I would want to remain anonymous too.

Who are these physicians and scientists in favor of suffering and death?

Okay, okay, I will shut up and present the letter.

anonymous-misinformation-cover-letter.pdf

Our previous blog covered the bogus report making the rounds, falsely disparaging Provenge. (see blog below Provenge is Approved but the Lies Continue)

This further dispels that bogus report. Care To Live has learned,

Dendritic/other immune cells are extravascular, not in the blood. Removing less than 3% of immune system. If you check 3 weeks after apheresis, level of immune cells in blood is same as prior to apheresis.

The immune cell count calculation within the report appears to be wrong. Based on the article, the calculation discussed the immunodepletion of the cells within the blood. However, the majority of immune cells are in the TISSUE, and not just in the blood. Dendreon measured the immunodepletion 3 weeks into the trial and that was normalized.

Within the clinical trials no increase in infection was seen between placebo arm and Provenge arm. This suggests a normalized immune system.

The survival in the control arm was no different than historical normals for Prostate Cancer.

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A bogus 27 page paper is being aggressively sent around wall street, and the medical, scientific regulatory and legal community, asking people to contact the FDA and the CMS. The cover letter touts the nonsense that they are scared to voice their concerns publicly. Feigning their safety fears is the same ploy they used last time, hiring bodyguards, at the taxpayers expense, fabricating non-existent threats, while no police reports ever turned up. This time we are determined to get to the bottom of it.

provenge-approval-fud.pdf

Their poor argument about the Phase III trial is dispelled here by Provenge advocate Ocyan:

This was a serious piece of work to support an argument that Dr. Hussain put up during the 2007 AC meeting when she said that the placebo protocol might have been active and could hurt patients. At that time, she gave no explanation of how that could be the case. Now, the argument is that it is immuno-depletion.

The basic idea is that a large number of immune cells were taken from a patient in a leukapheresis procedure. If a patient was on the treatment arm, he would get most of them back on reinfusion. However, if a patient was on the control arm, he only got back less than a third of what was taken during the leukapheresis procedure. Therefore, the immune system of a placebo patient was suppressed. That is called immuno-depletion.

The immuno-depletion attack on Provenge goes like this. Because of immuno-depletion, Continue Reading Provenge Is Approved But The Lies Continue »

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FDA returned on April 8th to check up on CTL.

Hey FDA, any word on Provenge approval yet, or are you still using snow days as an excuse to deny the treatment to the men who so desperately need it.

You are welcome to our site anytime. We look forward to seeing you in person at our next demonstration, but until then, make yourself at home here.

Oh, and we are still awaiting a response to our letter to Josh Sharfstein. Could you remind him to give us a call?

Thanks Brenda!

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Dear FDA,

As you read this on your next visit here, why not just agree to meet with us in person.

Are you aware Ms. Midthun refused our request to meet with her?

Here is her reply:

 http://caretolive.com/2010-01-11/cber-responds-to-letter-from-caretolive/

If you are interested in how we feel and what we seek to accomplish, then PLEASE meet with us.

We are planning a demonstration at the FDA in front of your building as that is the only alternative left to get your attention. We are sure you will see that news here first….so until next time…..

We know you are watching us. What are you looking for? Better yet, what are you waiting for?

CareToLive set up this website in June 2007. It was an information site for people protesting the FDA’s poor decision to delay getting Provenge, a safe and effective, non-toxic immunotherapy for men with late stage prostate cancer. These men are dying in excruciating pain and have no other viable treatment option.

Provenge met the criteria for approval as it has proven survival, the gold standard for approval. A panel of FDA hand-picked experts voted Provenge safe, 17-0, and that it demonstrated substantial evidence of efficacy, 13-4.

CareToLive watched as people approached the last FDA Commissioner, Andrew Von Eschenbach, and asked him to reconsider the decision. They gave him some very good reasons. Mr. Von Eschenbach refused.  CareToLive incorporated, filed a Citizen’s Petition, and then a lawsuit, and challenged the FDA decision. CareToLive spelled out why Provenge was not given proper due process by the FDA when it processed the Biologic License Application (BLA).

In July 2007 the FDA visited this site. What was it looking for? It was very late at night, around 10:30. Who was at the FDA office and what were they looking for over here? Is that when they gathered to shred and delete documents in response to our lawsuit?

Here is a list for the past seven months when the FDA stopped by this website.

The FDA stopped by:
09/01/09
10/06/09 
10/23/09
10/28/09
11/23/09
12/04/09
12/28/09
12/29/09
12/30/09
01/03/10
01/19/10
01/20/10
01/21/10
02/25/10 
03/11/10
03/25/10

The NIH stopped by
12/02/09

Memorial Sloan-Kettering stopped by
12/04/09 
12/28/09 

Once again, what is the FDA looking for? More important, what is the FDA waiting for? If they read our blogs they saw the latest data presentation from Dendreon, the manufacturer of Provenge. It demonstrates the same safe profile and the survival advantage is better than anything available, by leaps and bounds. What are you waiting for FDA? Approve Provenge NOW!

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Senseless years of death and delay for late stage prostate cancer patients while FDA Honchos collect huge salaries, enjoying life to the fullest.

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