The median overall survival benefit of PROVENGE in the Phase 3 IMPACT Trial was estimated to be 7.8 months.

Care To Live has always believed Provenge should have been approved way back in May 2007. We were delighted when it finally was approved in May of 2010, albeit 3 years after it should have been due to the FDA’s malfeasance. This latest news further fortifies the 2007 survival results.

Dendreon presented the following data to the American Society of Clinical Oncology 2012 Genitourinary Cancers Symposium in San Francisco, California.

• “An Analysis to Quantify the Overall Survival (OS) Benefit of Sipuleucel-T Accounting for the Crossover in the Control Arm of the IMPACT Study,” abstract #144 - Thursday, February 2, 2012.
• “Sipuleucel-T Product Characterization Across Different Disease States of Prostate Cancer,” abstract #42 - on Thursday, February 2, 2012.
• “Neoadjuvant Sipuleucel-T in Patients with Localized Prostate Cancer: Immune Responses in Prostate Tumor Tissue,” abstract #181 - on Friday, February 3, 2012.
• “Evaluation of Immune Activation Following Neoadjuvant Sipuleucel-T in Subjects with Localized Prostate Cancer,” abstract #178 - on Friday, February 3, 2012.

“For the past 15 years, Dendreon has been focused on changing the way that cancer is treated,” said Mark Frohlich, MD, chief medical officer. “These latest findings continue to support the overall survival benefit of PROVENGE, and its mechanism of action. They provide a strong rationale for examining PROVENGE earlier in prostate cancer.”

Abstract #144: An Analysis to Quantify the Overall Survival (OS) Benefit of Sipuleucel-T Accounting for the Crossover in the Control Arm of the IMPACT Study

The Phase 3 IMPACT trial included a crossover design that allowed patients who were randomized to the control arm and experienced disease progression the opportunity to participate in an open label Phase 2 protocol to receive APC8015F, an investigational autologous cellular immunotherapy made from cells that were cryopreserved at the time the control was manufactured. As a result, 109 out of the 171 control patients (64%) received APC8015F.

In this exploratory analysis, researchers used a rank-preserving structural failure time (RPSFT) model, to quantify how treatment with APC8015F might have impacted the overall survival of the Phase 3 IMPACT trial by adjusting for the positive treatment effect of APC8015F in the control arm. The previously published intent to treat analysis, which is described in the Food and Drug Administration (FDA) approved prescribing information for PROVENGE, did not account for cross-over and demonstrated a 4.1 month median survival benefit (HR=0.775, 95% CI: 0.614, 0.979). Using the RPSFT model, and assuming that APC8015F was equally effective as PROVENGE, the median overall survival benefit of PROVENGE in the Phase 3 IMPACT trial was estimated to be 7.8 months, had there been no cross-over to APC8015F (HR=0.60, 95% CI: 0.41, 0.95).

“The results of this exploratory analysis are encouraging,” said Chadi Nabhan, MD, Oncology Specialists S.C., Lutheran General Hospital Cancer Care Center. “These data continue to support the use of PROVENGE as an important and compelling treatment option for men with certain types of advanced prostate cancer.”

Abstract #42: Sipuleucel-T Product Characterization Across Different Disease States of Prostate Cancer

An exploratory analysis of several PROVENGE clinical trials (IMPACT, ProACT, OpenACT, and NeoACT) examined the product characteristics of PROVENGE comparatively across different disease states (asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer (mCRPC), and mCRPC, and neoadjuvant).

The pattern of antigen presenting cell (APC) activation, as measured by upregulation of CD54, was consistent across all of the clinical trials, with increased APC activation at the second and third PROVENGE treatments relative to the first. The second and third dose of PROVENGE also consistently showed enhanced expression of lymphocyte activation markers and cytokines. APC activation tended to be more robust in earlier disease states, as evidence by increased cumulative fold increase in CD54 upregulation in neoadjuvant patients (35.5) relative to asymptomatic or minimally symptomatic mCRPC (28.7) and mCRPC patients (21.8; P < 0.0001).

“I find these data to be very compelling — this exploratory analysis provides insight into the biological effect of PROVENGE and immunologic activity across different stages of prostate cancer,” said Eric Small, MD, University of California, San Francisco Helen Diller Family Comprehensive Cancer Center. “These data suggest that PROVENGE should be studied in earlier stages of disease, when patients have less tumor burden.”

Abstract #181: Neoadjuvant Sipuleucel-T in Patients with Localized Prostate Cancer: Immune Responses in Prostate Tumor Tissue

A Phase 2 study, called NeoACT (NEOadjuvant Active Cellular immunoTherapy), evaluated treatment with PROVENGE prior to radical prostatectomy in patients with localized prostate cancer. PROVENGE is not currently indicated in this setting. This analysis assessed the presence of lymphocytes by immunohistochemistry (IHC) in radical prostatectomy tissue following treatment with PROVENGE and compared it to prostate biopsy tissue obtained prior to treatment.

At the time of abstract submission, IHC analysis had been completed in 19 patients. Significant increases ( > 2-fold) in CD3⁺ and CD4⁺ T-cells populations were observed at the tumor rim between the interface of benign and malignant tissue when compared with the pretreatment biopsy tissue (ANOVA post hoc Newman-Keuls test: P=0.0002, both).

“This analysis of prostate tissue from patients participating in the Phase 2 NeoACT trial demonstrated increased T-cell activity at the rims of prostate cancer tumors, which provides important support for PROVENGE’s intended mechanism of action,” said Lawrence Fong, MD, University of California, San Francisco Helen Diller Family Comprehensive Cancer Center.

Abstract #178: Evaluation of Immune Activation Following Neoadjuvant Sipuleucel-T in Subjects with Localized Prostate Cancer

In addition, a second analysis of the Phase 2 NeoACT study evaluated immune activation in PROVENGE for patients with localized prostate cancer treated prior to surgery. This analysis evaluated the cellular composition and APC activation of the product both prior to and after the culture with the recombinant fusion protein PA2024, consisting of prostatic acid phosphatase (PAP) and granulocyte macrophage colony stimulating factor (GMCSF).

The Phase 2 NeoACT study enrolled 42 patients and 38 received all three infusions of PROVENGE. Consistent with past findings in PROVENGE mCRPC trials, CD54 upregulation (APC activation) was greater at the second and third PROVENGE infusions. The expression of early T-cell activation markers (CD134, CD137, CD278 and CD279) was increased in cells obtained after the first infusion of PROVENGE, and then further increased post-culture with PA2024. Also observed was a progressive increase in memory B-cells (CD20⁺CD27⁺IgD^-CD86⁺; pre- and post-culture) and activated mature B-cells (CD20⁺CD27⁺IgD⁺CD86⁺; post-culture) following the first infusion of PROVENGE. Activated T-cell-associated cytokines were significantly elevated (TNF-α, P < 0.001; IFN-γ, P < 0.001; and IL-2, P < 0.001) in the second and third PROVENGE doses.

Initial results from the trial indicate neoadjuvant treatment with PROVENGE showed evidence of immune system activation that included APCs, memory and activated mature B-cells, and both CD4⁺ and CD8⁺ T-cells. This analysis supports further studies to evaluate the use of PROVENGE in localized prostate cancer.

About the IMPACT Trial

IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) is a 512-patient, multi-center, randomized, double-blind, controlled study evaluating men with asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. The primary endpoint was overall survival.

Initial results from the IMPACT study found PROVENGE extended median survival by 4.1 months compared to control (25.8 months vs. 21.7 months) and reduced the risk of death by 22.5 percent compared to control. Control used in the trial was non-activated autologous peripheral blood mononuclear cells. The survival benefit associated with PROVENGE was observed consistently across multiple patient subgroups, including those with prognostic factors known to be adversely correlated with overall survival, such as PSA, LDH, alkaline phosphatase, number of bone metastasis, Gleason score, performance status, and presence of pain.

Adverse events more commonly reported in the PROVENGE arm of this study included chills, fever, headache, influenza-like illness, muscle aches, hypertension and groin pain.

PROVENGE Indication and Important Safety Information

PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.

PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.

The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis. The most common adverse events (incidence greater-than or equal to 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.

To fulfill a post marketing requirement and as a part of the company’s ongoing commitment to patients, Dendreon will conduct a registry of approximately 1500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.

For more information on PROVENGE, please see the full prescribing information at http://www.provenge.com or call 1-877-336-3736.

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.

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

New Orleans
wwltv.com

Posted on July 12, 2011 at 10:45 PM

“the first patient at the Tulane Cancer Center to try a new way of fighting prostate cancer that has metastasized to other areas of the body. The treatment he is trying will actually turn his own immune system in to a prostate cancer killing drug of sorts.”

http://www.wwltv.com/news/New-form-of-treatment-gives-prostate-cancer-patients-hope-125462708.html

Care To Live urges all people who have a beef with the FDA to make a sign and join them.

Freedom of Access to Medicines, along with the Abigail Alliance for
Better Access to Developmental Drugs, and others plan to hold a peaceful
protest outside the FDA hearings on Avastin on June 28th, 2011.

The protest is in support of the fight of women to choose the
life-saving drug Avastin, and the issue of better access to promising
developmental therapies for cancer and other serious life threatening illnesses.
An estimated 17,500 women with incurable metastatic breast cancer
currently rely on Avastin to stay alive. With your help, they and their
doctors will remain free to choose Avastin.

Due to the actions of the U.S. Food and Drug Administration, these
women’s lives are threatened. Defend these women’s right to choose the
medicines that keep them alive today and you will be protecting your life
tomorrow.

The location of the June 28-29 hearing will be the Great Room on the
FDA White Oak Campus located at 10903 New Hampshire Avenue, Silver
Spring, MD 20993.

For more information about the White Oak Campus, please click on this www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm[1]
More details regarding the protest will soon be available at:
http://www.fameds.org/protest.php

Abigail Alliance for Better Access to Developmental Drugs
www.abigail-alliance.org[2]
8881 White Orchid Place
Lorton, VA 22079
703-646-5306

COMPASSIONATE ACCESS ACT: The Abigail Alliance along with others is
in the process of very significantly reinvigorating the Compassionate
Access Act in the U.S. Congress.

DOCUMENTARY: Sometime mid to late this year a documentary featuring
the Abigail Alliance will be coming out!

ALSO, the Abigail Alliance has a VERY tight budget, so your help
KEEPS US GOING.

Donate to Abigail Alliance

Links:
——
[1]
http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm
[2] http://www.abigail-alliance.org

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 (more…)


      
]]>
			http://caretolive.com/2011-06-09/rip-charles-a-reinwald-%e2%80%94-cancer-cure-coalition-founder/feed/

		
		
		
		http://caretolive.com/2011-04-29/care-to-live-submits-moment-of-silence-to-cms/
		http://caretolive.com/2011-04-29/care-to-live-submits-moment-of-silence-to-cms/#comments
		Sat, 30 Apr 2011 04:18:35 +0000
		CTL
		
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		http://caretolive.com/2011-04-29/care-to-live-submits-moment-of-silence-to-cms/
		
			Dear CMS,

Please consider first and foremost the men and the families who love them. These are the true beneficiaries of the Provenge Medicare coverage. To you they may be portrayed as points on a graph, but to us, each and every one of these men, matter greatly. We call them Dad, Grandpa, Son, Brother and Husband.
During the approval and now coverage process, we have experienced moments of extreme joy and devastating heartbreak. The almost five year old continuing Provenge saga, ongoing since Dendreon first filed the clinical portion of their Biologics License Application with the FDA in 2006, has ended up on your doorstep to make a coverage determination by June 30. So many of our men’s hopes and health are now riding on you.
We at Care To Live would like to make clear to CMS, FDA, NCI and all the other government agencies peripherally involved, that this process that Provenge and other treatments go through is much too long and much too arduous for the patients awaiting treatment. Serious consideration must be given to find ways to get these exciting new treatments to the patients who are without viable alternatives to death, sooner, including passage of the Abigail Alliance sponsored Access Act.
The FDA in particular, needs to help bring treatments for late stage disease, like late stage prostate cancer, to the patients earlier. During the Provenge approval process, the FDA and the NCI sadly acted as patient adversaries and barriers, instead of the bridge that we were promised.
Within CMS’ own walls, mistakes were made. We hope you will strive to avoid these careless actions in the future. Never should safety and efficacy, already put through a long and laborious FDA review process, ever be evaluated by your agency. If you decide to evaluate a treatment based upon your stated intentions, such as uniformity of coverage and classification of reimbursement, then you must make it very clear at the outset that this is your intention.
CMS lacks authority to re-evaluate data provided by the FDA for a treatment’s safety and efficacy. Such action is particularly ill conceived when it is a treatment for late stage cancer. Without fast action by Dendreon, patient advocates, and several Congressmen, many more men may have been denied treatment. Total catastrophe was averted but not before your agency came close to creating chaos as seen through the eyes of many patients, some of whom urged Congress to get involved.
This should never be allowed to happen again.
Despite what some have said in these comments and elsewhere, making late stage prostate cancer patients out to be sick old men, that is just plain wrong. Most are still active, vital people, with no outward signs of disease. Some are still quite young, and all, if left untreated, will die too early of a very painful disease.
We are not about to let that happen. Care To Live  (more…)

      
]]>
			http://caretolive.com/2011-04-29/care-to-live-submits-moment-of-silence-to-cms/feed/
		
		
		
		http://caretolive.com/2011-04-28/hhs-desperately-needs-transparency-lessons-from-cms/
		http://caretolive.com/2011-04-28/hhs-desperately-needs-transparency-lessons-from-cms/#comments
		Thu, 28 Apr 2011 09:54:38 +0000
		CTL
		
		

		

		

		

		

		

		

		

		

		

		

		

		

		

		

		http://caretolive.com/2011-04-28/hhs-desperately-needs-transparency-lessons-from-cms/
		
			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/

      
]]>
			http://caretolive.com/2011-04-28/hhs-desperately-needs-transparency-lessons-from-cms/feed/
		
		
		
		http://caretolive.com/2011-04-23/please-post-for-provenge/
		http://caretolive.com/2011-04-23/please-post-for-provenge/#comments
		Sat, 23 Apr 2011 13:45:05 +0000
		CTL
		
		

		

		

		

		

		

		

		

		

		http://caretolive.com/2011-04-23/please-post-for-provenge/
		
			Click Here >> to go to the CMS Comment Page

The April 29, 2011 Deadline is fast approaching. Take Nothing for granted.
 Please take a moment to write a sentence or two to the Centers for Medicaid  and Medicare (CMS) requesting them to continue providing coverage for Provenge, the FDA approved immunotherapy for late stage prostate cancer.  It is a non toxic, non invasive FDA approved treatment, safer and more effective than anything that  has been previously approved.
1 in 6 men get prostate  cancer in their lifetimes. 30,000 a year go on to die from it. Provenge is the first approved treatment of its kind, which utilizes your own immune system to fight off the cancer.
In order to post, you must first open the CMS PHI Posting Policy link and then  remember to click the box below it:
I have read and understand the CMS policy regarding redaction of PHI.

Thank you for your prompt attention to this matter as this is time sensitive.
PS: If you have friends that will help, please email and forward. TIA
http://caretolive.com/Click Here >> on the CMS Comment Page to comment on the Autologous Cellular Immunotherapy  Treatment of Metastatic Prostate Cancer (00422N).
Care  To Live urges all of its friends and members to post a comment on the  Centers for Medicare & Medicaid Services (CMS) web page encouraging  them to support coverage of Dendreon’s Provenge.
Thank You,
Rory Kearney

President

Care To LIve,

a not for profit corporation
View Public Comments CAG-00422N  Comment Period:  03/30/2011-04/29/2011
http://www.cms.gov/medicare-coverage-database/details/nca-view-public-comments.aspx

?NCAId=247&ExpandComments=n&ver=11&NcaName=Autologous+Cellular+Immunotherapy+Treatment+of+

Metastatic+Prostate+Cancer&DocID=CAG-00422N&SearchType=

Advanced&bc=IAAAABAAEAAA&





Date 


Pos.


Neg. 


Total




31-Mar


0


2


2




1-Apr


53


1


54




2-Apr


12


0


12




3-Apr


15


0


15




4-Apr


54


0


54




5-Apr


14


0


14




6-Apr


11


0


11




7-Apr


3


0


3




8-Apr


2


0


2




9-Apr


2


0


2




10-Apr


1


0


1




11-Apr


3


0


3




12-Apr


0


0


0




13-Apr


2


0


2




14-Apr


0


0


0




15-Apr


28


0


28




16-Apr


14


1


15




17-Apr


9


0


9




18-Apr


26


0


26




19-Apr


106


1


107




20-Apr


28


1


29




 


383


6


389




      
]]>
			http://caretolive.com/2011-04-23/please-post-for-provenge/feed/
		
		
		
		http://caretolive.com/2011-04-19/final-3/
		http://caretolive.com/2011-04-19/final-3/#comments
		Tue, 19 Apr 2011 17:58:40 +0000
		CTL
		
		

		

		

		

		

		

		

		

		http://caretolive.com/2011-04-19/final-3/
		
			Correction: this is not the final response.

 http://caretolive.com/Pages%201%20to%2050%20CTL%20CMS%20docs%20041811
http://caretolive.com/Pages%2051%20to%20100%20CTL%20CMS%20docs%20041811 
http://caretolive.com/Pages%20101%20to%20151%20CTL%20CMS%20docs%20041811
http://caretolive.com/Pages%20152%20to%20200%20CTL%20CMS%20docs%20041811
http://caretolive.com/Pages%20201%20to%20250%20CTL%20CMS%20docs%20041811
http://caretolive.com/Pages%20251%20to%20300%20CTL%20CMS%20docs%20041811
http://caretolive.com/CTL%20CMS%200418%20docs%20301-385

      
]]>
			http://caretolive.com/2011-04-19/final-3/feed/