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%

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

Popularity: 14%

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 Continue Reading Care To Live Submits Moment of Silence to CMS »

Popularity: 29%

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:

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&

Popularity: 22%

Good News! Provenge is becoming increasingly available. Dendreon is ramping up the supply following the recent approval of the remaining 75% of their New Jersey plant.

To find out more about Provenge, a first in class immunotherapy treatment for prostate cancer, click this link Provenge.com.

To find out where provenge is available near you, go to the bottom left of that page to this link Find a PROVENGE Provider. Then, insert your zip code to find the locations in your area.

Recently conducted channel checking indicates that demand remains strong.

That data suggests:

The number of patients prescribed Provenge within their sample is up 22.7% sequentially, while the number of new patients who actually received the treatment is up 66.7%.

This is good news indeed!

Popularity: 22%

Today Care To Live received additional documents from the Center of Medicaid and Medicare Services in response to our Freedom of Information (FOIA) requests.

part-1-cms-foia-3_30_11.pdf

part-2-cms-foia-3_30_11.pdf

part-3-cms-foia-3_30_11.pdf

part-4-cms-foia-3_30_11.pdf

part-5-cms-foia-3_30_11.pdf

part-6-cms-foia-3_30_11.pdf

part-7-cms-foia-3_30_11.pdf

part-8-cms-foia-3_30_11.pdf

part-9-cms-foia-3_30_11.pdf

part-10-cms-foia-3_30_11.pdf

Popularity: 22%

Care To Live has been notified by the Department of Justice (DOJ) that the final FOIA response from CMS is expected to be completed and released to CTL not later than April 15, 2011.

As soon as it is released, it will be posted here in its entirety.

Popularity: 14%

Yesterday, the Dendreon Corporation announced some data presentations that were to take place at the 2011 Genitourinary Cancers Symposium annual meeting in Orlando, Florida. In one of the presentations, there were data that showed subsequent treatment with APC8015F (frozen Provenge called Frovenge) may have prolonged survival of the control arm in Phase 3 Sipuleucel-T Studies.

Dendreon’s press release can be read here:

http://finance.yahoo.com/news/Dendreon-Announces-prnews-2424909414.html?x=0&.v=1

When Dendreon performed their trials, all the men gave blood samples and had that blood treated with Provenge. In the placebo control group they did not get infused with that treated blood, rather it was frozen to preserve it. It was called Frovenge, a less potent form of Provenge.

For humane reasons, upon progression of deteriorating patients in the placebo arm, Frovenge was administered, now competing against itself, as mandated by the FDA for the placebo group in the Provenge trial.

Now we are seeing results which show that Frovenge worked. It extended survival. We really do not know how good this treatment is, but so far it is performing beyond our expectations. Thinking how this groundbreaking medical science is planned for other cancers is truly exciting.

Here is another article commenting on this new data:

http://seekingalpha.com/article/253708-good-news-for-dendreon-s-provenge?source=yahoo

Popularity: 10%

Dr. Scott Gottlieb and Henry Miller (see blog below) recently criticized the FDA for its go slow, risk adverse nature, which is stifling innovation and costing patients quality of life time with family.

Here is the link to Steve Forbes recent article called: How the FDA May Kill Millions of Us.

http://www.forbes.com/forbes/2011/0214/opinions-steve-forbes-fact-comment-fda-may-kill-millions.html

Mr. Forbes states, “A more fruitful approach would be to overhaul the FDA and remove its capricious hurdles.”

The FDA needs patient advocates on staff with real authority to help patients, who can work with patient advocacy groups to enable patients to gain access to innovative treatments sooner. The FDA needs to balance the wealth of statistically rigid bureaucrats who are unable to understand how to weigh benefit - risk in a meaningful manner.

The FDA needs to accelerate approvals and streamline the process. An ongoing example of FDA incompetence is the still non-approval of Dendreon’s NJ Provenge plant, whose request they have had for 3 months now…….while men still cannot obtain the treatment due to supply shortages.

Prostate cancer patients are tired of dying while waiting for the FDA to do its job.

Popularity: 12%

by Kerry M. Donahue

FDA commissioner Margaret Hamburg recently defended the FDA against criticisms leveled by former FDA Deputy Commissioner Dr. Scott Gottlieb and Hoover Institute fellow Henry Miller. She took issue with the idea that the FDA is not following the mandates of Congress to get safe and effective new treatments to patients in a timely way, particularly late stage patients with few, if any, viable alternatives.

Of course those who followed the Provenge approval process with CareToLive understand that FDA figurehead Hamburg is baffled, befuddled and completely out of touch with the reality of the situation. Ms. Hamburg needs to look no further than the case of Provenge and the now 15 other effective treatments for late stage diseases that heroes like Frank Burroughs at the Abigail Alliance http://abigail-alliance.org/ supported, and which were all eventually approved for treatment of life threatening diseases. Unfortunately not before hundreds of thousands of patients died, sometimes from terrible and painful diseases, without ever having been able to obtain these treatments.

The fault lies squarely with the FDA process and their failure to prioritize and accelerate review as demanded by Congress, and by humanity itself. Continue Reading FDA Trifecta — Gottlieb Calls Em Out, Miller Rallies on the Rail, Hamburg Limps Lamely to Finish »

Popularity: 15%