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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Thanks to many people working behind the scenes, Care To Live is able to monitor some of the formal investigations being pursued by the Federal government and others regarding the questionable actions taken against Dendreon since 2005. It is CTL’s position that some of the miscreants involved in the 2007 sabotage of the Provenge approval process are still keeping Dendreon on the ropes to this day.

Had Provenge been approved conditionally and humanely, as it should have been in May 2007—with a post-approval phase IV trial performed— it would have become, as it should be, the standard of care for end stage prostate cancer. Instead, approval was delayed three (3) years, with the concomitant loss of 100,000 lives, many of which could have been extended through the use of Provenge.

Despite the nearly insurmountable barriers placed in its path by Wall Street, together with corruption in the FDA approval process that has been well documented in the literature through the efforts of Care To Live and our many supporters (see, for example, the seminal piece by Mark Mitchell, Michael Milken and Dendreon* [ http://www.deepcapture.com/wp-content/uploads/story-of-dendreon.pdf ], Provenge has become the first and so far, only immunotherapy for cancer that the FDA has ever approved, making medical history for the good of all people.

Capping the egregious events that marked the Provenge Advisory Committee (AC) Meeting of March 29, 2007, and the events that followed—including the three letters to Dr. von Eschenbach written by Drs. Howard Scher and Maha Hussain (both of whom served as special government employees on the AC) and Dr. Thomas Fleming, a statistician — as well as the $440M deal between Novacea (for which Scher was conducting trials) and Shering-Plough just three weeks after the FDA sent Dendreon ‘back to the drawing board,’ was the Bear Raid on Dendreon’s stock on April 28, 2009.  On that date, shortly before Dendreon was to announce (positive) material information, the stock dropped from $24.50 to $7.50 in 75 seconds. Importantly, the ‘flash crash’ was announced by a poster on the Dendreon Yahoo! message board known as ‘monthaphumchareon.’ (And seriously…75 years old and a female?)

http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_D/threadview?m=tm&bn=5342&tid=708092&mid=708150&tof=-1&rt=2&frt=2&off=1

The April 28 “flash crash” bear raid was yet another example of sociopathic Wall Street manipulation, this time, perhaps, intended to allow traders and hedge funds caught in a trap on the ‘short side’ and facing good corporate news on the positive results of the Phase III Provenge trial to exit their positions and go ‘long’ ahead of Dr. Mitch Gold’s conference call. Even with the ‘smoking gun’—that is, the pre-announcement of the bear raid for which a subpoena could have been issued to obtain a person’s name—FINRA let all of the trades stand, and the SEC stood by doing nothing.

This is what passes for ‘oversight’ by our regulators of the US stock markets. Is it any wonder that Bernie Madoff pulled the wool over their eyes for 10 years? No wonder Harry Markopolos testified before the US Senate that the SEC was a ‘captured regulator’ controlled by the very industry it was commissioned to oversee.

Complaints to the SEC and FINRA by CTL and others resulted in no actions being taken. However, one supporter did catch the attention of Senator Chuck Grassley (R, IA), who demanded an investigation. The first hint of this came in the SEC OIG’s Semi-Annual Report to Congress in November, 2009:

http://www.sec-oig.gov/Reports/Semiannual/2009/semifall09.pdf   text, page 98

Allegations of Failure to Investigate

The OIG has opened an investigation into complaints from an investor alleging that the SEC failed to investigate instances of market manipulation and other misconduct in connection with the review, and eventual nonapproval, of a developmental drug. The investor also has alleged that the SEC failed to investigate a recent bear raid on the stock of the company that developed the drug, causing a severe plunge in the stock price. The OIG has reviewed several hundred pages of documents, including numerous e-mails and attachments provided by the complainant. The OIG expects to complete its investigation and issue a report of investigation in the next reporting period.

This was followed by:

http://www.sec-oig.gov/Reports/Semiannual/2010/semiapr10.pdf  text, page 73

Allegations of Enforcement Failure to Investigate (Report No. OIG-521)
“The OIG opened an investigation on August 6, 2009, after receiving an investor complaint from the office of Senator Charles E. Grassley (R-Iowa), alleging that a “bear raid” against a manufacturer that took place in 2009, resulting in a 65 percent drop in the company’s stock price within 75 seconds. According to the complainant, an Internet message board posting warned of the bear raid in advance of the precipitous fall in the stock price. The complainant further alleged that the SEC failed to investigate this bear raid, as well as additional instances of misconduct in connection with the review, and eventual non-approval, of a company product. The complainant also alleged that certain non-SEC government employees were responsible for serious improprieties in the product approval process and, due to conflicts of interest, should never have been allowed to participate in the process. The focus of the OIG’s investigation was to determine whether the SEC had, in fact, failed to investigate the possible manipulation of the company’s stock, in the form of a bear raid, as alleged.

“During the course of this investigation, the OIG reviewed numerous pages of correspondence and supporting materials provided by the complainant, including approximately 200 e-mails and many attachments thereto. The OIG also reviewed internal SEC case tracking reports for evidence of SEC investigative activity. Finally, the OIG interviewed the complainant, as well as two Enforcement staff members in an effort to determine whether there was an investigation into the alleged bear raid on the company’s stock.

“After conducting a thorough investigation into the complainant’s allegations against the SEC, the OIG issued its report to management on December 9, 2009. In the report, we determined that the SEC was, in fact, actively investigating the specific instance of market manipulation identified by the complainant, namely, the alleged bear raid against the company’s stock. We also determined that the complainant’s allegations that conflicts of interest tainted the product approval process were not within the OIG’s jurisdiction to investigate. Finally, the OIG provided Enforcement staff with the complainant’s numerous materials, and will continue to monitor the progress of Enforcement’s investigation of possible market manipulation related to the Internet message board posting.”

For well over a year, US news agencies and CTL have been attempting to secure a copy of both the Enforcement Division’s and the OIG’s formal Reports in this matter. Recently, we have been successful, and today, are able to provide you with the Report of Investigation by the SEC Office of Inspector General in the matter of OIG-521 and a response letter:

SEC Response Letter – OIG -521.pdf

SEC Report - OIG-521.pdf

There are several interesting things to note about this OIG-521, beginning with Footnote 6. This is a clear reference to Mark Mitchell’s DeepCapture article (really, an exposé of the heinous crimes committed).  It is a ridiculous reference, and completely misstates fact. It’s almost as if the IG staff is laughing about what it has read in DeepCapture…assuming it even read the 15-chapter story. We suspect that either the OIG staffers deliberately misconstrued the story (unlikely) or took someone else’s word as to what was in the story and didn’t bother to read it themselves (more likely).

Now, we certainly wouldn’t expect that the OIG had time to read a book-length Internet story, but for them to suggest that the story suggests a dark Mafia conspiracy is irresponsible and suggests that the OIG isn’t taking seriously the broader allegations that Dendreon was manipulated over a long period of time. It doesn’t take a genius to look at the price action in Dendron’s common stock over the years together with the bombardment of false and negative information regarding the company and its lead product, Provenge, to know that the share price has been manipulated for quite some time for a number of reasons, both market related as well as of a competitive nature.

So, from the standpoint of Footnote 6, then, we are disappointed that once again, as in the case of Harry Markopolos, the SEC OIG (and the Enforcement Division?) has apparently chosen to ignore the warning signs and may be allowing this travesty to slip through the cracks.

Another very disturbing thing about the OIG-521 Report is the fact that despite repeated attempts to call attention to problems related to special government employees (and others) who participated in the Provenge Advisory Committee, the HHS OIG’s Dan Levinson has so far refused to open an investigation into these matters. Material has repeatedly been sent to him by individuals, Sen. Grassley, and the SEC OIG. Yet, a review of the HHS OIG Semi-Annual Reports to Congress reveal nothing in the way of an investigation.

It should be clear to even the most casual reader that the three-year delay in the approval of Provenge, a non-invasive, non-toxic immunotherapy, was, without question, intended to ‘buy time’ for other of drugs in development to push through trials and into the marketplace. Consider this quote from the Provenge AC of March 29, 2007, by Dr. Scher:

15 offer patients. So if I start thinking, am
16 I denying a potentially useful agent to men
17 who clearly need it, the answer is
18 unfortunately I don’t know. So I say well,

19 what if we think that this really should be
20 available, start thinking about the number

21 of agents that are currently under
22 development…

P. 321, Provenge Advisory Committee Meeting

It should be noted that Dr. Scher uttered these words as a special government employee at a time when he was serving as co-lead on the development of Asentar, Novacea’s drug for prostate cancer. (The trial was subsequently stopped when it was found the drugged was killing patients.) At this time, too, Dr. Scher had a relationship with Cougar Biotechnology, which not only was later bought out by Johnson & Johnson, but which recently received approval for what now is known as Zytiga. Even more interesting is the fact that in damning Provenge, both during the meeting and later, in his leaked letter to Dr. von Eschenbach, Dr. Scher admitted that he had no experience whatsoever with Provenge:

1 DR. SCHER: Personally I have no
2 experience with this agent, so I’d just like
3 to ask the clinicians who have used it, we
4 all understand the difficulties assessing
5 time-to-progression and how it does not
6 associate with survival as we are currently
7 measuring it.

P. 87, Provenge Advisory Committee Meeting

Finally, there is the question of whether or not the Enforcement Division is or has conducted an investigation into this matter. Repeated FOIA requests finally brought the (verbal) result that no formal Report similar to Report OIG-521 has been written by the Enforcement Division. It has been confirmed, however —again, through a recent FOIA request—that all of the material provided to Sen. Grassley and the SEC OIG (and, subsequently, to the Enforcement Division) does still exist, so at least we know that it has not been destroyed. Some readers of this Blog may recall that recently Matt Taibbi wrote about a whistleblower who revealed the following:

“Imagine a world in which a man who is repeatedly investigated for a string of serious crimes, but never prosecuted, has his slate wiped clean every time the cops fail to make a case. No more Lifetime channel specials where the murderer is unveiled after police stumble upon past intrigues in some old file – “Hey, chief, didja know this guy had two wives die falling down the stairs?” No more burglary sprees cracked when some sharp cop sees the same name pop up in one too many witness statements. This is a different world, one far friendlier to lawbreakers, where even the suspicion of wrongdoing gets wiped from the record.

“That, it now appears, is exactly how the Securities and Exchange Commission has been treating the Wall Street criminals who cratered the global economy a few years back. For the past two decades, according to a whistle-blower at the SEC who recently came forward to Congress, the agency has been systematically destroying records of its preliminary investigations once they are closed. By whitewashing the files of some of the nation’s worst financial criminals, the SEC has kept an entire generation of federal investigators in the dark about past inquiries into insider trading, fraud and market manipulation against companies like Goldman Sachs, Deutsche Bank and AIG. With a few strokes of the keyboard, the evidence gathered during thousands of investigations – “18,000 … including Madoff,” as one high-ranking SEC official put it during a panicked meeting about the destruction – has apparently disappeared forever into the wormhole of history.”

http://www.rollingstone.com/politics/news/is-the-sec-covering-up-wall-street-crimes-20110817

It didn’t take William Cohan long to call for the SEC to be shut down, something with which we couldn’t agree more:

“Thanks to Darcy Flynn, a longtime attorney at the Securities and Exchange Commission, we now have all the ammunition we need to do what should have been done years ago: terminate the SEC, with extreme prejudice, and in its place construct a new regulatory watchdog for Wall Street free of obvious conflicts of interest.

“Flynn’s courage has almost been lost in all the recent apocalyptic talk of earthquakes and hurricanes, but a few weeks back he did something remarkable. After raising concerns internally at the SEC last year — and getting nowhere — Flynn went public and alleged in a formal whistleblower complaint that for at least 17 years the SEC “followed a policy of systematically destroying documents” related to what are known as Matters Under Investigation, or MUIs, most of which were focused on possibly illicit or illegal behavior at Wall Street firms. MUIs are the first step in investigating a case that may lead to a formal SEC inquiry. Flynn alleged the MUIs were destroyed after the cases were closed when they should have been retained. He catalogued his complaints in a letter to Senator Charles Grassley, an Iowa Republican and the ranking member of the Senate Judiciary Committee. Grassley wrote to Mary Schapiro, the head of the SEC, asking her to respond to him about Flynn’s allegations by tomorrow. She hasn’t yet done so as of yesterday.

“In his letter to Grassley, Flynn alleged that the SEC had destroyed documents related to MUIs involving Bernard Madoff; Goldman Sachs Group Inc. (GS)’s trading in the credit-default swaps of insurer American International Group Inc. (AIG); “financial fraud” at Wells Fargo & Co. (WFC) and Bank of America Corp. (BAC); and “insider-trading investigations” at Deutsche Bank AG (DBK), Lehman Brothers Holdings Inc. (LEHMQ) and SAC Capital Advisors LP.

http://www.bloomberg.com/news/2011-08-30/one-more-reason-to-shut-sec-and-start-over-commentary-by-william-d-cohan.html

While the second OIG Semi-Annual Report to Congress states that the IG would continue to monitor this issue, the Report states that for now, it has closed this matter (p. 7).

Finally, we note that a considerable amount of material has been redacted at the end of the Report. This material was withheld in accordance with the third paragraph of the cover letter:

“Further, we are withholding certain information within OIG-
521 pursuant to 5 U.S.C. § 552(b)(7)(A), 17 CFR §
200.80(b)(7)(i). This exemption protects from disclosure
Information compiled for law enforcement purposes, the release
of which could reasonably be expected to interfere with
enforcement activities. Because the underlying circumstances
may change, we may later disclose some of this information. If
you wish, you may make another request six months from the date
of this letter.”

Whether or not actual “law enforcement” activities are ongoing is questionable. It’s been more than two years since the Bear Raid, and considering that the SEC was handed the smoking gun (the name of the person who preannounced the raid) and the fact that no sign of action has been forthcoming, we at CTL are skeptical that the Securities and Exchange Commission is capable of doing anything properly.

*Mark Mitchell’s seminal piece on Dendreon, Michael Milken and Dendreon, will be released this fall in book form. The tradeback (paperback) book will be entitled The Dendreon Effect: How Felons, Con-men and Wall Street Insiders Manipulate High-tech Stocks, from Silver Lake Publishing. Readers also may enjoy Theodore Jerome Cohen’s Death by Wall Street: Rampage of the Bulls, which is based on the Dendreon story. http://www.theodore-cohen-novels.com/deathbywallstreet.html

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With our deepest condolences we mourn the loss from prostate cancer, June 2, 2011 at 85 years of age, of one of Care To Live’s fiercest warriors during our battle for Provenge’s approval.  We never did, nor could we, thank him enough for all his help. Sometimes with death there is a revisiting of the person, and we welcome this opportunity to bring you Charles A. Reinwald the man, and his unique and incredible cancer foundation, with its focus on healing cancer, both medically and holistically.

A link to his website has always been right up there, on the top of our home page. Please add it to your ‘to do’ list. If you are a cancer patient, the Cancer Cure Coalition should be your first line of defense.

http://www.cancercurecoalition.org

Cancer Cure Coalition Mission Statement

http://www.cancercurecoalition.org/mission.html

Charles A Reinwald Biography

http://www.cancercurecoalition.org/board.html

Charles became a member of Care To Live early on. He was a great advocate of strengthening the immune system through diet and lifestyle changes, as well as medicine. Throughout the years Charles offered us advice, and support. He was fighting many wars, on many cancer fronts, but was never too tired to write one more letter or one more article, or to offer words of encouragement in our darkest hours, when we needed them most.

Charles was a rarity today. A true patient advocate, not beholden to any corporate or financial conflicts of interests.  He was not an investor in Dendreon which frustrated the likes of those reporters whose deviant agendas were to erroneously portray Provenge as ineffectual, such as Matthew Herper of Forbes Magazine.

A brilliant man, he strove to understand health and wellness better, utiliizing his vast talents to educate and share what he learned with others. That is what made him truly stand out from the pack.

Care to Live literally stood shoulder to shoulder with Charles at our Rockville, Maryland FDA protest on September 18, 2007. He was one of our keynote speakers.

Charles A. Reinwald lives on in the families who will receive Provenge, those patient advocate and those with cancer whose lives he touched directly, his wife, his children, several of whom attended our Provenge 10 city rally in Cleveland in 2008, his grandchildren, and through his wonderful Cancer Cure Coalition Foundation.

I strongly urge people to send donations to:

The Cancer Cure Coalition
305 Beach Road, Suite 204
Tequesta, FL 33469

Telephone: (561) 747-2127

a 501 (C) (3) tax exempt charitable organization. Your donations are tax deductible pursuant to the Internal Revenue Code.

* * * * *

In February 2008 Mr. Reinwald took the FDA to task in this press release.

http://www.reuters.com/article/2008/02/21/idUS136546+21-Feb-2008+PRN20080221

Cancer Cure Coalition Proposes Major Changes at the FDA

Thu Feb 21, 2008 7:45am EST

PALMS BEACH GARDENS, Fla., Feb. 21 /PRNewswire/ -- Flawed policies and bad

decisions at the FDA have contributed to an escalation of the cost of clinical

trials which now take an average of one billion dollars and require 10 years

for approval. This has delayed and even prevented the availability of many Continue Reading RIP Charles A. Reinwald — Cancer Cure Coalition Founder »

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Although the Court of Appeals decision did not go our way in the case of CTL vs. FDA, whereby we are seeking documents Richard Pazdur declared he shredded and deleted, the Court was kind enough to inform us that our initial request was not specific enough. Therefore Care To Live has filed a new Freedom of Information Act (FOIA) request, which is on its way to the FDA’s Division of Freedom of Information as I post this.

CTL is asking for all documents and e-mails, among other things, sent to and from Richard Pazdur during the period October 1, 2006 through October 1, 2007, inclusive. CTL is quite specific this time in detailing exactly what we are asking them to search for.

The new FOIA request can be seen here:

ctl-cder-foia-request.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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Dendreon announced updated results today from its pivotal Phase 3 IMPACT trial for late stage prostate cancer. The results were even better than we expected. According to Dendreon, the study “demonstrated that PROVENGE increased three-year survival by 40 percent compared to placebo.”

This is truly awesome and in line with what we always believed about the potential of Provenge and Immunotherapy. Dr. Phillip Kantoff, the Director of the Lank Center for Genitourinary Oncology, Chief of the Division of Solid Tumor Oncology, and Chief Clinical Research Officer at Dana-Farber Cancer Institute, Professor of Medicine at Harvard Medical School, and principal investigator of the IMPACT study, said it best:

“The results from the IMPACT study corroborate earlier studies with sipuleucel-T in demonstrating an improvement in overall survival for men with metastatic castration resistant prostate cancer.”

This is why CareToLive, represented by our attorney, Kerry M. Donahue, fought so long and so hard to keep Provenge in the limelight after the FDA delayed approval for almost 3 years to date.

The earlier studies which were reviewed by an FDA Advisory Committee back in March 2007 demonstrated survival, the FDA gold standard for approval of cancer treatments, especially for terminal patients who had no other options, yet we are still awaiting approval.

Dr. Kantoff reminded us that we are seeing medical history:

“This is the first therapeutic vaccine to demonstrate a survival benefit in cancer.”

This goes way beyond prostate cancer because Dendreon is going to use similar treatments to try to tackle other cancers, such as breast,  colon , ovarian cancer, etc.

Although safety was never a concern in prior trials, rumors abounded, and today, Dr. Kantoff, in the press release, tames that concern while reiterating the medical history we are about to experience:

“Furthermore, the results of this study validate cancer immunotherapy as an entirely new treatment paradigm that can provide patients with a clinically meaningful survival benefit coupled with a well-tolerated safety profile.”

CareToLive is thrilled to proudly broadcast this great news.

The three-year survival by 40% compared to placebo is record breaking. Now we need the FDA to  enable the men in dire need to get Provenge ASAP!

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