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

Popularity: 12%

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

Popularity: 15%

The real story—the tragedy in this case, and the one yet to be told by the so-called “Mainstream Media”—is the story of the needless three-year delay in availability of Dendreon’s Provenge for our sons, fathers, and grandfathers.

The Dendreon Investor Village (IV) message board at www.investorvillage.com(link) is where a group of the most well-informed people in the world on all-things-Dendreon, exchange information. Many have posted there non-stop since early in the decade. One daily post entitled “Daily Death Count”, documents the number of men who have died of prostate cancer since “Black Wednesday” (link to Mark Thornton op ed), May 8, 2007, the date the FDA went against the recommendation of its own Advisory Committee and refused to approve Provenge. As of this past Thursday, the date Provenge received final approval, the death count stood at 90,055. Every one of these 90,055 men were deeply loved and now dearly missed by their families and friends.

It’s difficult to ignore the fact that the March 29, 2007 Provenge Advisory Committee voted unanimously (17-0) that the drug is SAFE, or the fact that the same Committee voted minutes later, (13-4) that the drug “demonstrated substantial evidence of efficacy,” the federally mandated standard in such reviews. But the FDA did. The FDA also ignored the fact that the treatment was being submitted to help men with end stage prostate cancer, the stage for which there is no viable treatment option. Provenge would have been their last resort. Continue Reading The Real Provenge Story »

Popularity: 50%

CareToLive attorney, Kerry M. Donahue, filed a motion on Monday, October 26, 2009, in the Sixth Circuit Court of the United States, asking the Court to allow leave to supplement the FOIA appeal record with previous documents, numbers 3, 20 and 29 from Southern District of Ohio case no. 07-729 CareToLive vs. von Eschenbach.

CareToLive was concerned about the possible destruction of documents by FDA employee Richard Pazdur so we filed a motion to preserve documents (document 3). Upon Pazdur’s discovery that the documents were being sought, he deleted the documents.

The Court denied that motion but verbally instructed FDA counsel to instruct its clients not to destroy any documents involved in pending litigation. Well that client did indeed destroy the documents and the lower Court denied the request by Appellant to obtain the date of the computer deletion of the records by the FDA.

Richard Pazdur of the FDA possessed said documents, both hard copies and electronically on his FDA computer. The affidavit from Richard Pazdur further indicates that the documents are now unavailable because the electronic copies were deleted and the hard copies were shredded, by him.

Kerry also writes in the motion for CareToLive, available here Motion To Supplement, that despite the lack of any reasonable search for the documents by Appellee and despite the lower Courts repeated refusal to allow discovery on the issue and without the lower Court even allowing Appellant the full opportunity to be heard, the District Court denied the Civil Rule 56(f) motion of Appellant and declined to allow even minimal discovery and a full response to Defendant-Appellee’s motion for Summary Judgment, which would have been appropriate based on the particular facts of this case.

These three documents, numbers 3, 20 and 29, are very important to the brief and oral arguments to be presented to this Court. Let’s hope the Sixth Circuit Court agrees and we can get to the real reason why Richard Pazdur stopped a safe, non-toxic treatment that extends survival from reaching men who were dying and had no other treatment options. Check back here as we will report on this case as it moves through the Court of Appeals.

Popularity: 11%

In Memoriam: August 24, 2009
Remembering Bruce Tower

On September 17th, 2007, I arrived at JJ Muldoon’s Pub in Gaithersburg Maryland around 9 PM. Before too long, I heard the thunderous voice of a distinguished looking gentleman. He was being escorted to a mini-van by a woman whom I found out was one of our heroines, Melody Davis. Many around them were making a fuss. As the word spread the atmosphere became electrifying. It’s when we all realized who this man was.

Bruce, suffering from late stage prostate cancer, was not in the best physical condition, but he nonetheless made the trip to Maryland to help us protest the next day outside the FDA Headquarters in Rockville. His gut-wrenching speech captured the audience and delivered the message. Many men, like him, need Provenge NOW. They could be strengthening their immune system, fighting the awful disease we know as prostate cancer.

On a Sunday afternoon in April 2008, I spoke to Bruce on the phone. We chatted a bit and then we discussed our fight for Provenge. It was almost a year now and he was willing to keep fighting right along with us. He gave us permission to use his picture and he wrote a letter which we published as an ad in the Rockville Gazette. It is a sad statement to say we had to pay a lot of money to get the story in the local newspaper in the hometown of the FDA. Several times he appeared on the Andrew Schorr Patient Power radio show with us. He and his wife Carol were there whenever we needed their help.

(click to enlarge)

Week 2 Ad Color caretoliverockvillegazette2ad.pdf

http://caretolive.com/2008-04-09/caretolive-continues-its-in-your-face-ad-campaign-asking-the-fda-to-approve-provenge-for-prostate-cancer-now/

In his letter, Bruce made a simple plea. “Here is my plea; FDA: Please approve Provenge NOW.”

He could have had it working in his body for over two years. Now he will never get the chance to try Provenge to fight for his life.

I can hardly type this now because I just learned we lost Bruce Tower. The emotions run strong. Sadness for Bruce’s family. Anger for the FDA playing the wrong kind of god and withholding a safe and effective treatment. From everything I learned about Bruce, he was a remarkable man, dedicated to his wife, children and grandchildren. He inspired and taught other kids as a soccer coach. He led by example. He was a fine citizen indeed.

From everything I learned about our modern day government, these self-serving fools in charge could basically not give a damn. They are out of touch. They lost control. They are driving a long train full of people to their death tricking them into thinking they are going over a bridge. I can tell you with certainty, there is no bridge.

The empty promises of Andrew von Eschenbach and the nerve of him, makes my blood run cold with contempt. To me, he is the epitome of the captured FDA as declared by Harry Markopolis. To me, he let his friendship with convicted felon Michael Milken ruin his objective mission to serve the American people. Von Eschenbach double-dipped with the FDA and NCI leadership. He already set the Conflict of Interest stage. How could he keep an eye on it when he was wallowing in it?

Poor Bruce and his family. They should have had better. Their goverment let them down. They paid their taxes for nothing, not to mention the pain Bruce endured in his final days. I heard Bruce handled it like the champion he is. He only wanted to see those around him smile and live the good life.

May God richly reward you, Bruce. You should hear those words of old, “Well done my good and faithful servant.” May God comfort your family. May you rest in peace.

Popularity: 14%

What made me sickest over the Larry King show on prostate cancer was in the beginning of the show, when Larry King stated something along the lines that if they find the cure for prostate cancer they just might have to name it or call it the Milken cure. That set the tone for the show and the angle he was playing.

Larry King lost most of his fortune not too many years ago flipping insurance policy’s under the advice of some scammers. It worked well until he found out he was the mark. To recover, it looks like he went with Madoff, where he was once again taken to the cleaners. In Milken he finally found someone with juice. The show was packed with the mutual admiration society. Milken is doing his image rehabilitation desperately seeking a pardon. Maybe Larry will have Kerry on next (I can dream).

Larry King, Mike Milken, John McEnroe, Colin Powell, Joe Torre, Rudolph Guiliani, a cast of big mouths with not one word to say about Provenge. They are a sickening, pathetic bunch. We know Larry knows about Provenge because many of our friends and members reached out to Larry in the past and more recently before the show. Now if I were a conspiracy theorist…

They never mentioned Provenge, a non toxic, non invasive safe and effective immunotherapy that harnesses and enhances your own healthy cells to fight your own prostate cancer cells. Some men with late stage pc are living 8 years later. 1 in 6 men will get prostate cancer in their lifetime.

Provenge should be on the market by next year, in spite of Milken. His chairman, Howard Scher of the Prostate Cancer Foundation Therapeutic Consortium, and Milken’s recently departed CEO, Alison Martin of the Melanoma Research Alliance, colluded on the leaked letters that stopped Provenge dead in its tracks from reaching the 69,000+ men who have died since May 2007.

Mark Mitchell of Deep Capture recently published an exposé about Milken’s part in the death of 60,000 men and the delay of Provenge. The complete story of Dendreon is now available  21 August 2009
Read the full story

The PCF is also trying to take credit for financing Provenge? It stated this because it sent some money to the University of San Francisco back in the year 2000 for Eric Small to work on immunotherapy. In 2006 Small wrote a rather positive article stating Provenge may work. In 2007 Howie Scher and Alison Martin used that 2006 abstract against Provenge highlighting the word “may” as to say it may not work. PCF cannot take credit here. It can take credit for two of its big shots stopping Provenge which had positive Phase III trials under its belt while Asentar, Abiraterone and GVAX, treatments the PCF touted, were only finished with Phase II trials.

Furthermore, in the 2005 PCF Annual Report, Novacea and Cougar did not give any money to PCF. Dendreon donated between $25k to $50K. Cell Genesis gave between $10K to $25K.

Not only did the PCF do nothing to push for Provenge approval, they actually accepted money from Dendreon to support the PCF. It should have been the other way around. Dendreon was struggling for every dollar it could muster, and must have felt it had to make a donation to PCF too! Something stinks in the world of Milken’s philanthropy and I can smell it all the way in New Jersey.

Continue Reading Hey Larry King! Do your homework!! »

Popularity: 14%

Hold the deck.

It’s certainly okay to have the opinion that the FDA made a reasonable choice at the time it denied approval to Provenge in 2007. It’s not the right opinion, but it is a defendable one. It is not all right, based on what we now know, to say they made the right decision.

On the other hand:

That the Provenge BLA was not afforded proper due process is an absolute. Because it clearly was not afforded proper due process nobody can say with any certainty that the FDA made a reasonable decision. Once the process is corrupted it’s all guesswork from there. Nobody knows for sure the extent of influences and back room shenanigans that occurred to assure that Provenge was not fairly evaluated. When CareToLive through litigation and FOIA’s tried to get information they were stymied by the FDA who went to great lengths to avoid any transparency on the issue.

There are aces scattered all over the floor at the FDA and a couple sticking out of a few sleeves so how can the game have been fairly played? Is it too much to ask for a fair game? The denial of a fair PROCESS is the one truth that the FDA could have, should have, admitted.

If that process occurred in a court room there would, at a minimum, have been declared a mistrial, when the evidence of such became known (which was made known to the FDA by petition, litigation and of course lots of letters).

That they did not make a reasonable and common sense decision based on the class of patients for which Provenge was seeking approval, or conduct a proper risk/benefit analysis with a focus on the fact that the treatment was destined for late stage patients is clear.

The FDA said two things that support this; One was that the minority voices on the AC panel were taken into consideration as a factor in the decision making process, and Two is that Richard Pazdur of CDER influenced that process. Top that off with an FDA commissioner who just happens to be a very good friend of Milken……

I don’t want the point to be lost that it is the position of CareToLive that there is no way anyone can say a reasonable decision was made, because the process was completely corrupted. CareToLive has sought accountability and transparency to determine in what ways the process fell short. If the FDA would show us the process then we might be persuaded otherwise. Until then and even because of the cover up itself, it has to be evaluated based on what we know.

The cover up and the lack of transparency is indicative that the FDA made a choice that transparency would make matters worse in this case. Otherwise, why fight so hard to keep the process from the public eye.

What other influences entered into the picture. Political pressure? Milken pressure? Financial pressure? Inside power struggles? Some or all of the above?

The deck was stacked. The dice were loaded. Everybody knows!

With all that you now know about Milken and the depths of his depravity, does it not trouble you that he had considerable control and influence over at least Scher, Martin and von Eschenbach if not others? Continue Reading American Hold ‘Em »

Popularity: 15%

CareToLive Attorney Kerry Donahue filed Plaintiff’s Reply to Defendant’s Memorandum in Opposition Plaintiff’s Motion for Leave to Conduct Discovery Under Civil Rule 56(f)

You can read the response here >> Response for Discovery

See Exhibit A >> exhibit-a-061609.pdf

See Exhibit B >> exhibit-b-061609.pdf

See Exhibit C* >> exhibitc.pdf

*Exhibit C — Taken from Demystifying Computer Forensics written by Johnette Hassell, Ph.D. and Susan Steen
CareToLive would like to thank the authors who were kind enough to let us use excerpts from their document — demystifying-computer-forensics.pdf . Johnette Hassell and Susan Steen are partners in Electronic Evidence Retrieval, L.L.C., a company specializing in computer forensics and other expert consultation and testimony in computer science. They have more than twenty years of experience in computer consultation and testimony, computer forensics, software and technical manual copyright infringement support, and programmatic research and evaluation. They can be reached at info@ElectronicEvidenceRetrieval.com or 504.483.0201 on the Gulf Coast and 970.922.7250 in the Rocky Mountain area. http://www.electronicevidenceretrieval.com/

Popularity: 14%

The FDA blew a golden opportunity.

It took them 2 years of foot dragging to reach their decision on our CareToLive Citizens’ Petition.

They DENIED it!

The only redeeming factor in their pages of excuses, is that the FDA stated 3 times that they will process the amended Dendreon BLA expeditiously.

We at CTL feel the FDA lacks the compassion and the scientific ability to evaluate our Petition.

With the stellar Provenge survival data recently exhibited, we believe the FDA should have immediately reconsidered their death rattle.

Apr 28, 2009
Data Presented at AUA Demonstrate PROVENGE Significantly Prolongs Survival for Men with Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study (LINK)

The dysfunctional, omnipotent FDA has spoken loudly and clearly to the men with late stage prostate cancer who are out of options.

You can’t have a safe and effective immunotherapy yet.

Go home and die!

You can read the FDA’s response here >> fda-response-to-citizens-petition.pdf

Here are some of our thoughts on the FDA response. We welcome your comments.

Before addressing the specific requests in your petition, we first want to make it clear that we share your concern for men suffering from advanced prostate cancer.

Too many men continue dying a painful death while the FDA continues to stonewall the approval of Provenge by not addressing the deception that took place during the Provenge approval process.

We are committed to expeditiously reviewing the new information as soon as it is submitted.

This was the only good thing we read in their response.

PLEASE HURRY.

THIS IS AN EMERGENCY!

FDA shares the goal of approving new products, such as Provenge, as soon as they are shown to be safe and effective.

Provenge has shown all along that it is safe and effective. The Advisory Committee questions are regulatory questions.

Is it safe?

Is there substantial evidence of efficacy?

The panel voted overwhelmingly that it is safe and effective.

The FDA response tried to gloss over the conspiracy and conflict-of-interest issues, simply denying them without offering any evidence.

The agency lied when it said Provenge didn’t slow progression in either 9901 or 9902A. The correct terminology would have been “did not slow progression with statistical significance.”

We think that 11.7 weeks vs. 10.0 weeks in the 9901 trial is evidence of slowed progression.

A p value of 0.052 (Journal of Clinical Oncology number) or 0.085 (FDA number) should not be taken lightly, even if it did barely miss statistical significance.

Combine that with the survival p value of 0.01, and that’s pretty convincing evidence that 9901 was a successful trial.

It is a lie that Provenge did not slow progression in 9901, and it is a lie that there is no positive correlation between progression (91.5-94.8%) and survival (99.0%). The FDA’s progression argument is a LIE.

FDA has a long history of permitting access to investigational drugs to treat serious and immediately life-threatening diseases without adequate available therapies. Individuals can obtain access by enrolling in on-going clinical investigations of such products, including any existing expanded access protocols.

Continue Reading FDA LIES & DENIES — CARE TO LIVE CRIES »

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Seems there is no moving forward without moving backwards, as much as moving forward would be the right thing for everyone to do. The FDA won’t allow us to move forward so we must forever walk them through the sins of the past. The FDA dooms themselves to forever be walked through events of the past, events of the present, and events of the future.

While they have the power to end it happily like good old Ebenezer, and to help Tiny Tim (Teddy), they choose to let it end without redemption for themselves. Ebenezer Scrooge epitomizes the current FDA.

http://www.youtube.com/watch?v=qY2TT_aj_Fw&feature=fvsr

First, today, we visit the Provenge of May’s gone past.

As you know shortly after the FDA announced that they were not going to approve Provenge in May 2007 advocates met with then commissioner Andrew von Eschenbach to discuss the mistake the FDA had made in denying the BLA for Provenge and not allowing late stage prostate cancer patients to have Provenge.

It appeared that absent from the group of advocates at that meeting was anyone from the Prostate Cancer Foundation. However, unbeknownst to the advocates there meeting with Dr. von Eschenbach, the Prostate Cancer Foundation was in fact there. The problem was they were there on the other side.

The Prostate Cancer Foundation had and has the ear of former commissioner Andrew von Eschenbach. It is now crystal clear that if they would have gone they would have been sitting on von Eschenbach’s side of the table. Since the Commissioner has left the FDA, CareToLive has requested his help and he has declined (that request was renewed after the data came in).

The advocates at the advocacy meeting might not have seen it in Andy’s eyes but in them were, Michael Milken, Jonathan Simons and Stuart Holden all from the PCF.

They had and have the ear of Dr. von Eschenbach. What good could it do for the advocates to meet with Andy von Eschenbach when the largest prostate cancer patient advocacy group was absent and was in fact telling von Eshenbach to do the opposite that the advocates at the meeting were advocating for? Did those advocates know that they were speaking to the commissioner and the PCF? It’s kind of like the old poker adage; if you are sitting at a poker table and you don’t know who the sucker is, it’s you. The chair that spoke loudest was the chair that sat empty. When is the PCF going to pull up its chair to the right side of the table?

Thy enemy has shown thyself and that enemy is within the advocacy groups themselves. In deference to Michael’s love for baseball: Does anyone doubt that if the PCF would just step up to the plate and call for accelerated approval they could hit a home run.

In September of 2007 on behalf of CareToLive I sent a letter to Michael Milken by regular U.S. mail seeking his support for the effort to make Provenge available to late stage prostate cancer patients. That letter was never responded to.

Aren’t Mr. Milken and his groups in favor of speedier approval and access to treatments for late stage disease when the patients are without good alternatives?

Michael Milken founded the group Faster Cures which has shown no indication that it is in fact willing to support getting treatments such as Provenge to the patients faster.

Mike Milken says:

FasterCures

This Washington, D.C.-based think tank is removing barriers to progress against all life-threatening diseases.

The FasterCures team is dedicated to saving lives by saving time.
Milken Institute

Mike and his Faster Cures both remain MIA!!

More importantly, the greatest scientific achievement in late stage prostate cancer treatment in modern history and the PCF does nothing to help groups like CareToLive and others to try and speed it to the patients. If not now when? They have no right to call themselves prostate cancer patient advocates. Since the new data was announced CareToLive again sought the assistance of the multimillion dollar funded Prostate Cancer Foundation. These requests have repeatedly been made by CareToLive and they have repeatedly been ignored by the largest, most powerful and influential prostate cancer advocacy group first made in 2007 and then later made by request at the April 24th 2009 PCF round table in Washington D.C. and then later made by e-mails and finally culminating in the open letter sent by e-mail and regular U.S. mail to PCF CEO Jonathan Simons.

Soon after the advocates meeting with Dr. von Eschenbach after the Provenge denial in 2007 came this event:

Los Angeles, 2007 Milken Institute Global Conference
Building a Food and Drug Administration for the 21st Century

Moderator:
Greg Simon, President, FasterCures/The Center for Accelerating Medical Solutions

Panelists:
David Gratzer, Senior Fellow, Center for Medical Progress, Manhattan Institute
Andrew von Eschenbach, Commissioner, U.S. Food and Drug Administration

Greg Simon, President of FasterCures/The Center for Accelerating Medical Solutions and panel moderator began by asking how we can take the FDA we have today and get to the one we need for the 21st century. Andrew von Eschenbach, Commissioner of the FDA said, “in essence, the FDA is an information management business, and the world around us is changing fast and the data is changing also.” Personalized medicine will fundamentally change how the FDA approaches its work and how it is organized and the types of skill sets employees need. Dr. von Eschenbach talked about how science has crossed the threshold where diseases can be viewed through a molecular prism. “This doesn’t have to be about the science of safety or efficacy, with new molecular medicine we can have both,” he pointed out.

Balancing patient safety with access will be critical. “We have these discussions and a lot of time is spent on safety but we need to be sure we have an innovative drug market,” offered David Gratzer, Senior Fellow at the Manhattan Institute. Moving towards a “lifecycle approach” at the FDA that balances safety and access is critical and was a key message of the 2006 Institute of Medicine study on drug safety.

Beth Seidenberg, Partner at Kleiner Perkins Caufield & Byers pointed out that the future is now. Programs at the FDA like the Critical Path Initiative need even more support and resources. “We need to give the FDA the tools, people, and money to ensure the agency can take advantage of these scientific advances.” A system of integrated medical information based on electronic health records and data sharing will allow for more streamlined post-marketing surveillance and will get the FDA away from paper to electronic files. Resources and systems change are needed to advance these IT systems at the agency. “We need to get around the proprietary relationship to data and see that having access to large population data sets is the only way to advance.”

When Greg Simon asked each panelist to name the most important next step for the agency two themes emerged: getting the agency more resources and the creation of a creative strategic plan that embraces the possibility of how personalized medicine can change how we currently approve drugs.

Andy also says:
http://www.mikemilken.com/videos.taf?video=6&type=wmp

Mr. Milken and the PCF: Today there are an estimated 10 million cancer survivors just in America alone — men and women who in many cases have life expectancies measured in months, not years. “Many would gladly enlist as foot soldiers in an effort to help cure a disease that in many cases will be genetically passed on to their children and grandchildren.”

* “Cancer researchers, clinicians, and patient advocates rarely speak with one voice on any subject related to the disease. They fight over funding priorities; they squabble over treatment options; they joust over the relevance of biological discoveries. But virtually everyone agrees that Milken deserves an enormous share of the credit for the progress made against this major killer. ‘Mike’s done more for prostate cancer research than anyone in America,’ says one of the nation’s best-known prostate surgeons, Patrick Walsh, head of urology at Johns Hopkins.”
* ” ‘Michael Milken changed the culture of [medical] research,’ says Andrew von Eschenbach, director of the National Cancer Institute. ‘He created a sense of urgency that focused on results and shortened the timeline. It took a business mindset to shake things up. What he’s done is now the model.’”

* ” ‘Michael is always thinking creatively,’ says [Dr. Leroy] Hood, sounding like a convert. ‘He transformed how you do research in the field of prostate cancer and how you think about aggressively going after a disease. It has been a real revolution.’ ”

Mr. Milken, Mr. Simons we want to speak with one voice, why won’t you return our call?

Why won’t you respond to our e-mails?

Why won’t you help us to help late stage cancer patients now?

Where is the disagreement with regards to Provenge and WHY won’t you help?

So you backed the wrong horse but there is still time to change your bets, still time to turn the cart upright, still time to wipe that egg off your face and move forward.

HELP!!!!!

Here is what the PCF as a group says:

Although there has been dramatic progress in finding better treatments, the impending increase in incidence makes the need greater than ever. Fortunately, recent advances in science have made the opportunities greater than ever as well. With your support, we will be able to pursue more of these opportunities and hasten the day when prostate cancer is merely a sad memory.

Hey PCF, why won’t you give us a straight answer on our call for helping Provenge get to the patients sooner?

It’s bad enough that you have been MIA these past 2 years but now you simply have no excuse.

Teddy needs Provenge now!

Ebenezer Scrooge said of Tiny Tim, “If he is going to die he should do it and decrease the surplus population”.

I hate to be so grim on a Sunday but I have no patience for the FDA’s lack of humanity and no tolerance for the PCF’s non-support of quicker approval of Provenge because they are afraid if they do that it may bruise their ego.

Even Scher and Coffey at the PCF round table said they would rally behind Provenge if the data was there on April 28th…where is the rally?

Really, where is the rally?

Lets go!

No more free pass.

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