To Catch A Rat — Illegal Rumor Mongering at its Lousiest

SEC Here is Herper's Hatchet Job on Dendreon's Provenge Prostate Cancer Immunotherapy which will be published in Forbes on September 15.

http://www.forbes.com/healthcare/forbes/2008/0915/070.html

#13

Scroll down for updates

Matt, You Didn't. You called Provenge LOUSY! You did! In an article you entitled Patient Power, you wrote, "The FDA was swayed by some prominent cancer researchers who wrote letters saying the data were lousy." Let me get this straight. Grown, credentialed oncologists, roaming the halls of our hospitals, talking about a treatment that will be a paradigm shift in the way cancer is treated, and they're calling it lousy? I had someone search all three letters and the word "Lousy" does not appear in any of them. I assume you are referring to the 3 doctors, Dr. Howard Scher, Dr. Maha Hussain, and Dr. Thomas R. Fleming, who leaked letters and worked hard to get Dendreon's Provenge delayed.

I draw your attention to what Dr. Howard Scher said at the Provenge Advisory hearing: "Personally I have no experience with this agent (Provenge), so I'd just like to ask clinicians who have used it." - Dr. Howard Scher at the Provenge Advisory Committee hearing. You left out the fact Scher, and Fleming made it known at the Provenge Advisory Committee hearing, or in their “leaked letter” to the FDA, that they were worried about other drugs under development and what would happen to them if Provenge were approved. What? We can't have more than one drug on the market? Men can chose from Viagra, Cialis, or Levitra for erectile dysfunction. Why weren't they permitted to choose from Provenge, Asentar, and GVAX over a life and death situation? That was a very disturbing question and showed their true colors.

In addition, Scher admitted in his letter published in the Cancer Letter that he was leading a trial for a competitor of Dendreon, namely Novacea's Asentar. Here's a guy admitting to the world he is passing judgment on a treatment as a member of the Provenge Advisory Committee while he's working for another company, a competitor, developing their own treatment. How does he even get on the Advisory Committee? Oh right. Richard Pazdur, the "Cancer Czar" stuck him on it at the last minute, after he filled out an incomplete waiver. I am sure you are aware that Dr. Scher was the one who designed the competing Novacea Asentar trial, which has since been stopped due to the toxic chemotherapy/asentar cocktail being administered too frequently, causing too many tragic events. Scher also worked on gvax, whose trial was also recently suspended. Scher is also an advisor in Proquest Investments. Can you spell C-O-N-F-L-I-C-T-E-D. Leaders in their field. I think not.

Patient Power, is an inappropriate name for your article. What power have you given the suffering cancer patients, Matt? You just helped shred what little power prostate cancer patients had left. Your article is nothing short of rumor mongering. Christopher Cox of the SEC says they are not going to tolerate rumor mongering anymore. You fanned the flames of this fire, Matt, and now you will have to bear the heat.

Please note the following concerning the SEC and Bear Stearns:
"In the aftermath, some raised questions about whether the rumors about Bear Stearns were true, renewing the debate about how to crack down on market manipulation based on false rumors.

"This time, however, the SEC and other regulators seem more serious. They have warned that they will act swiftly and forcefully against any such market manipulation. The SEC has suggested that a wave of enforcement actions may be on the horizon as they and other regulators do what they can to protect market integrity, including placing unprecedented limits on short sellers in an effort to slow downward price movements in financial company stocks."

"SEC Chairman Christopher Cox stated that the message of the case was 'simple and direct': The SEC 'will vigorously investigate and prosecute those who manipulate markets with this witch's brew of damaging rumors and short sales.'"

http://www.law.com/jsp/ihc/PubArticleIHC.jsp?id=1202424050510

Matt, you dragged in Paul Goldberg, editor of The Cancer Letter, who leaked the 3 leaked letters used to delay Provenge, letters that were full of deception, but never sorted out by the corrupt and conflicted FDA. You do remember Paul Goldberg, Matt? He was the one who leaked the Imclone delay tipping off the investment world that Imclone wouldn't be approved. Dr. Sam Waksal, CEO of Imclone, and Martha Stewart, domestic diva, got caught up in some friendly fire, and went to jail. Matt, weren't you the first one on the scene to let us know that Maha Hussain had leaked a letter, even before it appeared in The Cancer Letter. You must have a special hot line (Or was it done via fax? They do have a fax machine, don't they?) to the Goldbergs.

You even quoted none other than Otis Brawley in your article. Otis is obviously a comrad of Paul Goldberg and The Cancer Letter. Remember the leaked letter on the FDA ImClone license delay (see below)? Imclone was subsequently licensed, but not before many men and women died without access. Matt, Otis was a very nice selection for your one-sided story.

You continue to harass Care To Live by trying to associate us with some captured oncologist's false memory recall, who were having nightmares that a group of patient's advocates were out to get them. The story was concocted to try to paint Care To Live and the Provenge advocates in a negative light, making them out to want to harm doctors. Nothing could be further from the truth and you know it. We admire, even revere, good, dedicated doctors. We object to conflicted doctors with devious agendas. I have spoken to you in person twice, as have many others, trying to get you to tell the true story, but you still print the same old tripe.

Were you afraid of me Matt? Were you afraid of anybody in our group? Were you afraid of any patient advocate for Provenge anywhere? I'll answer for you. NO! Why do you continue to perpetuate that lie along with all the other rumor mongering financial "journalists", who perpetuate that lie? That's pretty lousy "reporting" if you ask me.

The Provenge science is good, and you can't bring up any facts to disparage it, so you continue to spread doubts and lousy misinformation instead, attacking the advocates and our attorney. You continue to go for the jugular of a peace loving group and lay the blame at our feet. How pathetic. When you can't argue the science or the facts, just make up lies. You accuse Provenge patient advocates of forcing the doctors to attend the ASCO convention with bodyguards. Nothing could be further from the truth. We are peace loving professionals, banded together to fight Wall Street, Big Pharma, the captured media (DeepCapture.com) and the corrupt FDA from discarding a better way to treat cancer. We want to save lives, and find better, safer, more humane treatments, not harm people.

We pointed all this out to you over and over again. We provided documentation proving that the FDA was requesting (as well as joking about) needing security prior to the formation of Care To Live (see below). I have included the last letter we sent to you, proving that what I said is true. Nobody has ever shown any Care To Live member, or any other Provenge advocate, to have threatened any doctor. There is even a reward of several thousand dollars being offered to anyone's charity of their choice if they can prove that any doctor was ever threatened over the delay of Provenge. To date, nobody has claimed the reward. Still, I have read that same fabrication over and over and over again, through the years, in different media articles. Why not just focus on the science?

You go on to say "But the group has alienated doctors who research cancer treatments. Many of them still doubt Provenge."

How do you know that, Matt? Did you talk to anybody but the conflicted few? Most oncologists are not even familiar with Provenge, since it is not available yet. What a biased thing to say. I strongly doubt you have the facts to back it up. Are you just speaking of the conflicted few that were used as "ringers" on the panel, and their cohorts, like Brawley, inside and outside of the agency. Why would an oncologist who wants to help men with prostate cancer be anything but delighted with a treatment that can help the men? Most oncologists actually care about their patients, Matt. Who, Matt? Tell me who said that. Oh, that's right, you can't reveal your sources.

And your ending, Matt, was a low blow, even for a bottom feeder like you.

"Especially in prostate cancer, I have seen a bunch of survivor groups that are not very interested in basing things on science and are basing things on emotion," says Otis Brawley, chief medical officer of the American Cancer Society. Brawley has come to see how the better patient groups evolve. They often go from brashly demanding cures to learning that some treatments that seemed to help, like bone marrow transplants for breast cancer, turned out to do harm."

Now you are implying that Provenge, voted 17-0 safe by 17 out of 17 panelists (even the 2 "ringers"), with almost no side effects, since it is just the priming of one's own personal white blood cells to fight one's own specific cancer, is harmful. A targeted personalized treatment will follow for breast, colon, lung etc. cancers if they prove it can do as well with those cancers as it has demonstrated in prostate cancer. So far, Phase I for breast cancer showed promising results. I guess Otis Brawley is the Doctor on Call when you need someone to defend an untenable position at the FDA.

And to imply the Care To Live are a bunch of imbeciles operating on emotion instead of science, when in reality Care To Live is made up of Doctors, including Oncologists, nurses, scientists, CPA's, lawyers, inventors, etc. along with some incredibly brilliant researchers who have verified the science, including our formidable Attorney Kerry Donahue, who has gone above and beyond the call of duty of a good citizen, to try to help the men who want Provenge now to fight for their lives. You really should never trash this man who, although not perfect, comes damn close to it. Kerry is the salt of the earth and admired around the world for his brains, his tenacity, and his generosity in trying to help the patients.

What a shabby patient advocate Dr. Otis Brawley turned out to be. Not only does he dislike Provenge without discussing the fundamentals, he goes off on a tangent of describing us as irrational. Total nonsense. His implying Provenge may be harmful is unconscionable. You must all be patting yourselves on the back for that one. And what Brawley probably doesn't know, some of these advocates did address Scher's letter and it was based on science .

You can find the rebuttals to the leaked letter here.

http://caretolive.com/Millerrebuttalscher.pdf

http://caretolive.com/walldiverrebuttaltoscher.pdf

http://caretolive.com/the-science/

I wonder if the SEC will call the Department of Justice to take some of the rumor mongerers out in handcuffs. Somebody has to be made an example to put a stop to this collusion to destroy companies and treatments. I know its hard to prove, and some of you "journalists" play cat and mouse with that, but one day the trap is gonna snap and catch a few big rats.

The only approved treatment for late stage prostate cancer in 43 years is chemotherapy. "Modern-day chemotherapy has its origins on the battlefields of the First World War. Military doctors noticed that soldiers exposed to mustard gas, a chemical warfare agent, died because their bone marrow was destroyed (a condition called 'bone marrow aplasia'). Doctors began to investigate why this might have happened, and in 1942, 'nitrogen mustard' was used in a hospital in the US to treat lymphoma patients, albeit with limited success. http://info.cancerresearchuk.org/cancerandresearch/learnaboutcancer/treatment/chemotherapy/

Chemotherapy kills off all the healthy cells along with the cancer cells. Isn't it better to leave a persons healthy cells intact to help fight the cancer?. Immunotherapy is a better way, but you seem to want to swirl in the same noxious stew, year after year. What doctor or reporter for that matter, wouldn't want an immunotherapy approved that demonstrated survival and was not toxic.

There are documents showing Provenge is safe and extends survival. Some men are living up to 7 years! It is a non invasive, non toxic treatment, that will change the way cancer is treated. The FDA has refused its license for over a year. In the meantime, men like Care To Live members Richard Ripp, Stephen Study Sr., and John Fish have passed away from prostate cancer, as have 30,000 American men each year (I don't have worldwide statistics), without access to a treatment which could potentially extend their lives for years.

Matt, your yellow journalism is so unobjective, that it leaves no room in the imagination to see it any other way. What you did is illegal. Most Care To Live members, along with other Provenge advocates, think you are one lousy captured reporter.

* * * * *
http://query.nytimes.com/gst/fullpage.html?res=9F02E7D7133FF935A25751C0A9649C8B63&sec=health&spon=&pagewanted=all

Here's Otis Brawley commenting in Paul Goldbergs Cancer Letter on Imclone.
New York Times
Icahn Seeking U.S. Approval For Big Stake In ImClone
By ANDREW POLLACK
Published: February 16, 2002
Excerpt
"The Cancer Letter, a Washington newsletter, reported new evidence yesterday that suggests that ImClone will need to do new clinical trials to have Erbitux approved, something that could delay the drug's approval for a year or more.
The newsletter said it had obtained the protocol -- the long list of procedures -- for the clinical trial that formed the basis of ImClone's application to the F.D.A. Three medical school oncologists who reviewed the protocol for the newsletter said the procedures did not clearly spell out which patients should be admitted. They also said the trial design changed as the trial progressed.
''Over all, this is a protocol that asks the wrong questions, and then is not tightly written and efficient,'' Dr. Otis Brawley, professor of medicine at Emory University, wrote in the newsletter. Neither ImClone nor Bristol-Myers would comment."
* * * * *

Mike and my letter to Matt Herper prior to his article, when he emailed us to comment.

Hey Matt,

Strong words to say "to force the FDA". Many people kindly asked the FDA to reconsider. On June 4, 2007, some gathered with FDA Commissioner Andy Von Eschenbach and politely asked the Commissioner to reconsider the decision. Many folks at the FDA were contacted and were asked to reconsider the decision, especially since the decision was severely tainted by a conflicted few. Then on July 27, 2007, we filed a Citizens Petition asking the FDA to reconsider and we listed the reasons. The FDA still has failed to properly respond to that petition. Have you read the entire petition, Matt? You can read it here:
http://caretolive.com/caretolivepetition.pdf

The point is, we took legal action later to compel the FDA to respond to the travesty, only after we first tried to get a response in a non-legal manner. Maybe you can contact some additional thought leaders, like Peter Barton Hutt, a professor at Harvard, who is an FDA supporter, yet he also feels like us that the FDA lacks transparency and accountability, or Thomas Farrington, Scott Gottlieb, or Dr. Robert Rostock? Why don't you interview any of the 13 panelists who voted in favor of approval based on Provenge's efficacy profile? I would like to hear their opinions. Why do I get the feeling from your questions that you are doing a hatchet job on us for the hedge funds and/or the FDA?

The FDA disregarded and disrespected prominent immunotherapists on its way to stop Provenge from getting to the men who severely need it and want it. The four people who voted no are in with the chemotherapy groups. Three of them refused to answer the regulatory question. Chemotherapy zaps cancer, immunotherapy needs time to ramp up. These chemo doctors were evaluating Provenge like a chemotherapy. It is an immunotherapy. In addition, there are some oncologists who like immunotherapy and what Provenge is showing.
Why mention the bodyguards with CareToLive's efforts? CareToLive did not organize the Chicago Rally. There were 13 peaceful patient advocates who demonstrated in Chicago. I have met you several times. Did you see anybody affiliated with Care To Live or any other advocacy group that did not conduct themselves in a most professional manner? We are gentlemen and women. We do not cause harm to people. Did you see anybody that was afraid, not counting our dying members who fear their end will be premature. There is no proof that any threats were actually made to the doctors. Please provide some. There are a few people, not CTL members, who have offered a reward if anybody can produce any evidence of threats to the doctors. Are you aware that Maha Hussain and Richard Pazdur spoke about having had prior discussions about getting bodyguards during a Junovan hearing, before the Chicago Rally was held, and the discussion was totally unrelated to Provenge? The Chicago Rally was doctors, nurses and professionals. Here is part of the FDA transcript that discusses Pazdur's prior call for security at the Junovan Hearing on May 9, 2007.

CHAIRPERSON HUSSAIN: Thank you.
15 Dr. Perry, a final comment.
16 DR. PERRY: Yes.
17 Dr. Pazdur, could I ask that we have security
18 next time?
19 DR. PAZDUR: I had asked for that previously,
20 and I will ask the executive secretary here to contact
21 her supervisors to ensure that. Please resend my email
22 that I sent to your boss.
Page 332
1 CHAIRPERSON HUSSAIN: Dr. Pazdur, can they
2 come with me until I get to Ann Arbor to my home?
3 (General laughter.)
4 DR. PERRY: The members of this Committee, if
5 we get paid anything, it's lost in the expense accounts.
6 DR. PAZDUR: I actually apologize for that.
7 DR. PERRY: Yes. We perform this as a public
8 service. We take a lot of grief from the public, the
9 people who speak, many of whom speak off topic and look
10 at this as a bully pulpit to criticize the members. I
11 think at the very least we should be secure. We should
12 have some degree of security so that our Chairman is not
13 threatened.
14 DR. PAZDUR: I couldn't agree with you more.
15 DR. PERRY: I didn't think we would differ on
16 this issue.
17 DR. PAZDUR: I could not agree with you more,
18 and I have brought this up to the FDA management staff.
19 I am directing Ms. Clifford to tonight to please contact
20 her boss. I think it is imperative that even before the
21 next meeting, tomorrow, our next session, that something
22 be in place.
Page 333
1 CHAIRPERSON HUSSAIN: Is that the Department
2 of Defense I hope?
3 (General laughter.)
4 CHAIRPERSON HUSSAIN: Okay. Thank you very
5 much. We will adjourn.
6 (WHEREUPON, at 4:28 p.m., the meeting was
7 adjourned.)

I hope your story will not be one-sided. Men are dying here. There are no other options. The FDA knew this before the Advisory Committee was called. The FDA knew the trial designs were small and done in an old-fashioned way because that was how they were done back then. The Advisory Committee was told all about it and to look at the survival. While preliminary studies failed to demonstrate that the drug could slow progression of the cancer, patients receiving Provenge lived an average of 4.5 months longer than patients taking a placebo. Eduardo Garcia, a Provenge trial recipient, is still alive and doing very well over 7 years later. Survival is the gold standard!

Tell your readers the real reason why CareToLive is a patient advocacy group. There was a terrible injustice done here. The Advisory Committee was tampered with. The panel was stacked. There were notes passed among the conflicted few. The regulatory question was tampered with. Three of the four no voters would not answer the regulatory question. Then the FDA Commissioner was lobbied. NCI jumped in to help write letters to give the public the idea there was something to be concerned about here. The letters were leaked. And the ringleader, Howard Scher, was found to be severely conflicted.

Now get on the phone and ask Scher about his investments and business relationships and tell him CareToLive says he has failed as a patient advocate.

Get on the phone and ask Richard Pazdur why he is stalling handing over the CDER Freedom of Information Act documents. Ask Pazdur what was so important that he had to pass a note to Maha Hussain in the middle of the Provenge Advisory Panel. Ask Pazdur if he had anything to do with the putting the Drs. up to writing letters that would later be leaked to The Cancer Letter asking the FDA to delay Provenge approval. Ask Pazdur if he helped leak the letters to the Goldbergs. We already know that Pazdur leaked the Imclone license denial to The Cancer Letter. Ask him about that, and if he thinks that is ethical. Ask Pazdur why some drugs are approved with small trials, and some are approved showing no survival advantage and great toxicity, yet Provenge was delayed.

Ask Pazdur why Avastin did not have to show survival for breast cancer patients and why it was a sympathetic decision and yet Provenge, which shows survival, Pazdur refuses to acknowledge it and has no sympathy for the 96,000 men who have late stage prostate cancer?

Get on the phone with Jesse Goodman and ask him why the FDA has never properly responded to our Citizen's petition despite the fact that it has been over a year and 38,000 American men with late stage PC died without ever having the chance to fight for their lives using Provenge, a safe, non toxic, non invasive immunotherapy that has demonstrated that it can prolong lives.
Get on the phone and find out what was in the letter that Scher wrote to Alison Martin at NCI which she refused to turn over to CareToLive under the Freedom of Information Act, and why she has suddenly left the National Cancer Institute to go to work in the private sector at a new organization founded under the auspices (patronage; support; sponsorship) of the Michael Milken Institute.

Don't ever forget what Scher said at the Advisory Committee hearing:
"Personally I have no experience with this agent (Provenge), so I'd just like to ask clinicians who have used it." - Dr. Howard Scher at the Provenge Advisory Committee hearing.

These are your stories, Matt. This is why we are fighting for the patients. This is why we are fighting the FDA. If they processed the BLA like they were supposed to, we wouldn't be here talking about it. Provenge passed all the Congressional thresholds for approval. A conflicted few stopped it. The least the FDA should have done was give it conditional approval. Why don't you use your investigative reporting experience and investigate the conflicts of interest (COI's), the tampered question, the FOIA documents being held back, the "leaked letters", the unanswered Citizen's Petition, and why prominent immunotherapists were ignored despite a Congressional mandate to take the advice of the FDA Advisory Panel to help speed drugs to people who are dying with no other treatment options?

I leave you with quotes by people, do note some are distinguished doctors, who reacted after Provenge was delayed:

"This is the first-ever cancer vaccine that targets established tumors. If this drug is approved, it will just open up more investigation in this area. This drug is very, very non-toxic." - Dr. Johannes Vieweg

"It is a vaccine in the sense that it juices up the immune system." - ABC News Medical Editor Dr. Timothy Johnson

"He told me it looked pretty bad." " I believe in Provenge because of the way I used to feel before the treatment and the way I felt afterwards. It was that dramatic." - Eduardo Garcia who took Provenge seven years ago

"Realistically, we have people who are dying of prostate cancer who can really utilize these pharmaceuticals and can utilize them now." - Urologist Dr. David Allen

"This is not like classic chemo; there is no loss of hair, no sickness associated with it. We are disappointed because I think that many of the people who are involved in the study, many of the site investigators who are experienced with the drug, feel that it's a safe drug and that it works... that it extends life in a very desperate group of patients." - Dr. David Penson

"We think a mistake has been made." - Dr. Mark Moyad

"We are disappointed that it's not going through and that it has to go back on the table to be approved. And, certainly, we've heard from our patients who are not happy about it." - Urologist Dr. David Samadi

"Tens of thousands of men like me will die before they get it." - Prostate cancer patient and advocate, Joel Nowak

"There are so many men around this country who are livid. They're angry that this drug has not been approved." -Prostate cancer patient and advocate, Steve Fleischmann

"No. Oh, please, no." - Prostate cancer patient Jim Lanpher

"When I went back to my support group, and I'm a support group leader, and I told these men that the FDA has delayed the approval of this, I watched tears coming down their cheeks because they had all their hope in trying a treatment that was going to have few side-effects and was going to prolong their life." - Prostate cancer patient and advocate, Jim Keifert

Sincerely,
Mike Kearney
Spokesperson for CareToLive, a not for profit corporation
www.caretolive.com

* * * * *

Daily Death Count: Today = 39,840

* * * * *

Here is a letter complaining to the SEC
http://www.investorvillage.com/smbd.asp?mb=971&mn=213400&pt=msg&mid=5513848
A letter from my Senator to me on Aug 27, 2008:
Dear Dr. D...
The officials to whom I've spoken at the SEC have responded to my recent request for a review of the case of the alleged illegal naked short selling of Dendreon stock, and related collusion among hedge funds, stock analysts and financial reporters.
I am so glad that you shared your concerns with me and that I was able to help resolve this matter. If you ever again feel that my office can assist you in any way, please let me know.
Sincerely,
...
The letter from the SEC to my Senator dated Aug 20th, 2008:
Dear Senator...
I am writing to confirm that we received your July 14th letter on behalf of your constituent Dr. D.. We are taking Dr. D's complaint concerning Dendreon and Regulation SHO very seriously and look forward to helping him as best we can.
As Dr. D.. indicates in his letter to you, we have corresponded with him on these same issues several times. Since our last correspondence with him on July 7th, the SEC has taken steps to help curtail the market impact of false rumors and illegal naked short selling to ensure that investors remain confident that trading can be conducted without the illegal influence of manipulation. Additionally, regarding Dendreon, we take the issue of collusion between hedge funds and other market participants such as stock analysts and financial reporters very seriously. The SEC announced on July 13th, 2008, that it is conducting examinations aimed at the prevention of such manipulation of securities prices. A copy of this release is enclosed. Because abusive "naked" short selling can exacerbate "distort and short" schemes fueled by false information provided by the financial press, stock analysts and other market participants, these actions are needed to ensure both that legitimate short selling is allowed to continue while preventing manipulators from forcing down prices without regard to supply and demand.
As we have indicated to Dr. D, we are taking his complaint very seriously, and have referred it to the appropriate people within the SEC.
Please understand that the SEC conducts its investigations on a confidential basis and thus we can neither confirm nor deny the existence of an investigation into the issues discussed above regarding Dendreon. .....
If you have further questions, please do not hesitate to contact me or suggest to Dr. D. that he may contact ...., an attorney on my staff at 202..... so that we can be of further assistance.
Sincerely,
...
Director
SEC
Office of Investigation and Advocacy
* * * * *
Dendreon Sticks Its Neck Out. Why not. The short & distort cartel has been crushing their stock for years.
It's nothing but rumors and manipulation.
Dendreon, makers of Provenge, the delayed immunotherapy for prostate cancer, signed a letter to the SEC,
DNDN OSTK - 15 Companies sign Naked Short Selling Letter to SEC
http://www.nowpublic.com/world/overstock-ceo-patrick-byrne-carpet-bombs-wall-street-media-don-harrold-show-video
Officers of 15 public companies' (including DNDN) joint anti-Naked Short Selling letter to SEC via counsel

http://sec.gov/comments/s7-20-08/s72008-528.pdf

August 21, 2008
Mr. Christopher Cox
Chairman
U.S. Securities and Exchange Commission
100 F Street, NE
Washington, DC 20549
Ms. Kathleen L. Casey Ms. Elisse B. Walter Mr. Luis A. Aguilar Mr. Troy A. Paredes
Commissioner Commissioner Commissioner Commissioner
U.S. Securities and Exchange Commission U.S. Securities and Exchange Commission
100 F Street, NE 100 F Street, NE
Washington, DC 20549 Washington, DC 20549

Strengthening Regulation SHO To Protect All Investors From Naked Short Selling

Dear Chairman Cox and Commissioners Casey, Walter, Aguilar and Paredes:

We are writing on behalf of public companies that strongly support proposals to strengthen rules that protect them from the abusive practice of naked short selling. In recent weeks, we have watched with approval as the Commission has taken important steps to protect some of our nation's largest financial institutions from the devastating impact of market manipulation and naked short selling. The emergency order issued on July 15, 2008, and extended on July 29, 2008, was clearly appropriate in light of recent market turmoil. The consequences of another failure among Wall Street's major banks-due not to lack of capital or liquidity, but to a loss of confidence stemming from illegal trading and rumor mongering-would have been dire. So we commend Chairman Cox and the entire Commission for moving quickly and taking a strong stand on this issue.

Moreover, we applaud the Commission's announced rulemaking intended to provide additional protections against abusive naked short selling in the broader market. As the Commission undertakes this initiative, we wanted to make sure that you have the perspective of public companies-other than the select financial institutions covered by the order-on this issue. In considering the rulemaking, we urge the Commission to incorporate the key elements of the emergency order into Regulation SHO and extend these protections to the securities of all public companies. We believe that doing so could effectively eliminate naked short selling and provide companies and investors alike with much needed relief from this significant threat to the integrity of our capital markets.

To be clear, we are not opposed to legal short selling. Legal short selling adds liquidity to the markets and provides an efficient mechanism for price discovery. However, naked short selling, as you know, is a crime. Naked short selling and failures to deliver (FTDs) adversely affect all public companies. At one time, it could be said that naked short selling presented a problem only for the smallest of public companies. As recent events have shown, any company can have its share price harmed by naked short selling, which generates what are in essence counterfeit shares and drives share price down unfairly, against market factors.

Since January 2005, Regulation SH0 has required that the stock exchanges publish daily a list of companies with FTDs over a specified threshold. Since that time, more than 7,000 unique tickers have appeared on the Threshold List. On March 31, 2008, the mark-to-market value of FTDs was $8.5 billion. Of that amount, $6.1 billion was in Threshold securities. Based on this data, one must conclude that Regulation SHO, as currently in effect, is not working. Indeed, there are many companies that have been on the Threshold List for months and some for years. The thirteen-day limit for delivering shares sold short has obviously failed to secure settlement and seems incapable of being enforced.
In connection with the rulemaking initiative, we believe that the protections of the emergency order should be extended to all public companies. The first element of the order, the pre-borrow requirement, would go far towards limiting naked short selling and the FTDs that can result. The emergency order also requires delivery of all shares sold short by T+3, the normal settlement period, without exceptions. If extended to the securities of all public companies, this "hard delivery" rule would virtually eliminate the ability to engage in naked short selling. Finally, the efficacy of a revised Regulation SHO, as with any rule, will depend on meaningful enforcement muscle. For this reason, we would also recommend that the Commission enhance the mechanisms to enforce Regulation SHO, including rules aimed at holding brokerldealers and prime brokers directly accountable for buy-ins and deliveries.

The U.S. Chamber of Commerce, the American Bankers Association, leading lawyers and academics and "Main Street" corporations, with millions of investors nationwide, have long sought from the Commission the very same protection that was provided the nineteen select institutions covered by the order. The Commission is expected to act evenhandedly to protect all investors from market manipulation and illegal trading and to maintain fair, orderly, and efficient markets for all participants. Therefore, we see no justification for not extending effective protection from naked short selling to all public companies, especially in these turbulent and uncertain times.

As we have seen from recent events, dominos that are smaller than investment banks can set off a chain reaction as destructive as the failure of a large bank, causing fear and great harm to the markets and resulting in damaging losses to innocent investors. Accordingly, we applaud your intended rulemaking in this area to provide additional protections to the broader market. Amending Regulation SHO to incorporate the elements of the emergency order would be a permanent solution to naked short selling and would be an outstanding legacy for this Commission to bestow on the markets.

Thank you for your consideration.
-
The following companies sign this letter to show their support, recognizing that given the breadth of issues and diversity of interests they represent, they may not agree with every point as stated, but wish the Commission to understand how strongly they share the general concerns expressed.

Adobe Systems Incorporated
Karen Cottle
Senior Vice President, General Counsel and Corporate Secretary
AMAG Pharmaceuticals, Inc.
Joseph L Farmer
General Counsel and Senior Vice President of Legal Affairs
American Capital, Ltd.
Samuel A. Flax
Executive Vice President and General Counsel
Calgon Carbon Corporation
Dennis M. Sheedy
Vice President, General Counsel and Secretary
Dendreon Corporation
Rick Hamm
Senior Vice President, Corporate Affairs and General Counsel
Dionex Corporation
Gina Christopher
Senior Corporate Counsel
Ditech Networks, Inc.
William Tamblyn
Chief Financial Officer, Executive Vice President
Endwave Corporation
Brett W. Wallace
Chief Financial Officer and Executive Vice President
EnerNOC, Inc.
David Samuels,
Executive Vice President and Corporate Secretary
Medis Technologies Ltd.
Robert K. Lifton
Chairman and Chief Executive Officer
NetScout Systems, Inc.
David Sommers
Chief Financial Officer and Senior Vice President, General Operations
NVlDlA Corporation
Christine Lillquist
Director Corporate Affairs
Overstock.com, Inc.
Jonathan E. Johnson, Ill
President
Quest Software, Inc.
J. Michael Vaughn
Vice President, General Counsel and Secretary
Sangamo BioSciences, Inc.
H. Ward Wolff
Executive Vice President and Chief Financial Officer
Eric C. Jensen, Esq.
cc: Erik R. Sirri, Director, Division of Trading and Markets
Florence Harmon, Acting Secretary, Office of the Secretary
FIVE PAL0 ALTO SQUARE. 3000 EL CAMINO REAL PAL0 ALTO, CA 94306-2155 T: (650) 843-5000 F: (650) 849-7400 WWW.COOLEY.COM
Eric C.Jensen
(650) 843-5049
ejensen@cooley.com
Regulation SHO Letter

* * * * *

In blog #11 and #12 http://www.nowpublic.com/world/i-aint-leavin-till-they-throw-me-out http://www.nowpublic.com/world/12-back-back I discussed more about this case and how we lost our appeal but we will be filing a MOTION TO THE SUPREME COURT TO REVIEW.

Mike K. had this to add:

My opinion is the lower court and the court of appeals were not looking at this case properly.

1) There are Federal Regulations for processing a BLA and they were ignored in this case. That should overrule the ripeness argument. For if the regulations were adhered to, men would be taking Provenge today. At the very least, Provenge should have received Conditional Approval.

2) If survival is the gold standard and Provenge showed that, FDA is blatantly denying a man a right to live, a constitutional right. There is very strong evidence of survival despite what a few conflicted doctors say. And note, these same doctors have no experience with immunotherapy.

Then we get to how the FDA explains it today. They can't comment on it right now because it is an unapproved treatment. See point #1. If the BLA process was followed according to Federal Regulations and Congressional mandates, the treatment is approved. It passed the Congressional guidelines.

So why doesn't the FDA want to talk about it? The FDA knows exactly what it did here. It used a small group of conflicted doctors to stop a treatment they did not want on the market. Scher made it be known at the Provenge Advisory Committee hearing he was worried about other drugs under development. What? We can't have more than one on the market? For erectile dysfunction men can choose from Viagra, Cialis, or Levitra. Why weren't they permitted to choose from Provenge, Asentar, and GVAX? That is a very huge tell.

After Scher explained why he could not vote for Provenge, because he was worried about other treatments under development, he followed up with that same idea in a leaked letter he signed. Of course we now know he had NCI folks help him write that letter but he mentioned in the Cancer Letter that he was leading a trial for a competitor of Dendreon, namely Novacea. Here's a guy admitting to the world he is passing judgment on a treatment as a member of the Provenge Advisory Committee while he's working for another company developing their treatment. That is another giant tell in this story.

Next, Thomas Fleming wrote a letter and reiterated the same thing. He said Scher couldn't sleep. How did he know? Fleming said he, too, couldn't sleep because he, too, was worried about other treatments under development.

Then Fleming did something very peculiar. He attacked the Spokesperson for the Provenge Advisory Committee, Dr. Celia Witten, and then he attacked immunotherapist, Dr. Franco Marincola, and then he attacked patient advocate, Robert Samuels who is a prostate cancer survivor. And Fleming only used part of Samuels' testimony and not the complete statement Robert made that the patients were aware of the risk and were willing to take it. A third big tell.

The FDA and NCI made sure they hit every angle when they sabotaged Provenge. They disregarded and disrespected prominent immunotherapists on their way to stop Provenge from getting to the men who severely need it and want it. They sided with four people who voted no and who are in with the chemotherapy groups. Three of them refused to answer the regulatory question. Chemotherapy zaps cancer, immunotherapy needs time to ramp up. These chemo doctors were evaluating Provenge like a chemotherapy. It is an immunotherapy! Then they went out of their way to leak deceptive information. This is what the courts should have looked at. Everything else is a smokescreen.

At its basic root, while preliminary studies failed to demonstrate that the drug could slow progression of the cancer, patients receiving Provenge lived an average of 4.5 months longer than patients taking a placebo. Survival is the gold standard!

Now take note of the Federal Regulations Scher and Pazdur, and those who colluded with them, violated to get what they wanted and not what was best for American men:

- They disrespected US Code 18 Section 208 by not checking COIs and by granting waivers and SGE forms without making sure they match up with the applicant's employers, their portfolio and their family's portfolio.

- They disrespected the regulatory question for efficacy as set by Congress.

- They disrespected the 180 day regulation to respond to Citizens Petitions.

- They disrespected FOIA laws by redacting things and not responding in a timely manner as stated by the FOIA. We are still waiting for the documents of Richard Pazdur. What is he hiding?

- They disrespected Advisory Committee laws that say the Chairman of the AC, in this case James Mule, should be at every hearing. We don't see his name in the NCI FOIA documents and e-mails. We don't think he presided over those meetings.

- They worked with the Goldbergs of the infamous Cancer Letter to talk when they are prohibited by law from talking.

The Goldbergs also act like they respect Federal Laws. In their "Distribution Policy for The Cancer Letter" they write, "If you are sending the newsletter to an unauthorized list, please stop; your actions are against Federal law." And on August 5, 2002, look at what the Washington Post said about Paul:

"Goldberg smelled a rat. He knew the FDA was prohibited by law from talking, which left the company free to say what it wanted. He used his long-standing contacts in the cancer research world to get his hands on a letter from the FDA to the company."

So if Paul knew the FDA was prohibited from talking how did he think it was ok for him to speak for them? He gave them a way around the Federal law.

And if Paul knew the FDA was prohibited by law from talking, does Paul agree that that means releasing letters Scher, Hussain, and Fleming wrote to the FDA? And did he use his long-standing contacts in the cancer research world (that wouldn't be NCI would it?) to get his hands on letters the doctors sent to the FDA? Of course, we all now know that included NCI doctors.

Yeah, regulations are nice to stand behind, especially when you are trying to defend the times you ignored them.

* * * * *

* * * * ** * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ** * * * * * * * * * * * * *

Enter the rabbit hole here --------------------> http://www.DeepCapture.com

To enter our $75,000 "Crack the Wall Street Cover-up!" contest read to the bottom of this (very long) story.

The Columbia School of Journalism is our nation’s finest. They grant the Pulitzer Prize, and their journal, The Columbia Journalism Review, is the profession’s gold standard. CJR reporters are high priests of a decaying temple, tending a flame in a land going dark.

In 2006 a CJR editor (a seasoned journalist formerly with Time magazine in Asia, The Wall Street Journal Europe, and The Far Eastern Economic Review) called me to discuss suspicions he was forming about the US financial media. I gave him leads but warned, “Chasing this will take you down a rabbit hole with no bottom.” For months he pursued his story against pressure and threats he once described as, “something out of a Hollywood B movie, but unlike the movies, the evil corporations fighting the journalist are not thugs burying toxic waste, they are Wall Street and the financial media itself.”

His exposé reveals a circle of corruption enclosing venerable Wall Street banks, shady offshore financiers, and suspiciously compliant reporters at The Wall Street Journal, Fortune, CNBC, and The New York Times. If you ever wonder how reporters react when a journalist investigates them (answer: like white-collar crooks they dodge interviews, lie, and hide behind lawyers), or if financial corruption interests you, then this is for you. It makes Grisham read like a book of bedtime stories, and exposes a scandal that may make Enron look like an afternoon tea.

By Patrick M. Byrne, Deep Capture Reporter

The Story of Deep Capture

NEW! Download the Story of Deep Capture in .pdf format.

By Mark Mitchell, with reporting by the Deep Capture Team

Introduction - by Mark Mitchell

I began working on a version of this story in January 2006, while serving as an editor for the Columbia Journalism Review, a publication tasked with upholding the standards of the American media. In November 2006, a hedge fund that was at the center of the scandal I was investigating offered the Columbia Journalism Review a great deal of money. Shortly before CJR accepted the money, I left my job, so I do not know if my editors, whom I believe to be honest people, would have allowed me to persevere. But I have no doubt that the hedge fund’s “beneficence” was aimed at preventing the publication of stories like this one.

And it might well have succeeded if Patrick Byrne had not approached me with an idea. Why not combine forces and spearhead a whole new approach to investigative journalism? Most media content is produced by rumpled journalists (i.e., people like me), working alone under tight constraints. Deep Capture could be something different - a power team circumventing the traditional media and pushing limits to uncover the truth.

When I entered the picture, this team had already established that a small number of law-breaking hedge funds had put the American financial system at risk of collapse. Indeed, the hedge funds are employing the same tactics that contributed to the stock market crash of 1929 and the Great Depression that followed. If you want to understand the current turmoil in our financial markets, you could do no better than to read the material in Deep Capture: The Analysis.

The lengthy (40,000 word) story that follows should help you to understand how - and why — Patrick came to embark on this project. I am the author of the story, and attest to its accuracy, but it benefits substantially from the work of the Deep Capture team: freelance researchers, bloggers, gonzo computer hackers, economists, and even a one-time foreign intelligence agent.

Some mainstream journalists will not like this story. They will perhaps disapprove of our methods or decry the advent of vigilante journalism. But most of all, they will not like this story because it is largely about them - a tale of reporters who seek to be players, but instead become pawns - a tale of prominent journalists who help cover up a massive financial crime while toadying to some of Wall Street’s slimiest operators.

* * * * * * * *

And it all starts when Patrick Byrne gets a phone call from the Easter Bunny. Really, that’s what the guy calls himself - the Easter Bunny - and he talks like the Bee Gees on fast forward, a nasally frantic falsetto, on and on about some kind of conspiracy involving big time Wall Street operators, the Mafia, and a bunch of famous journalists. Somebody’s got to stop these people, the Bunny says, or the American financial system is going to come crashing to its knees. Also, the bad guys might put a bullet between the Easter Bunny’s ears.

* * * * *

Part 1 — Naked Shorts — $75,000 For Cracking the Wall Street Cover-up
by RoryKearney | July 11, 2008 at 07:13 am | 6635 views | 33 comments
http://www.nowpublic.com/world/naked-shorts-75-000-cracking-wall-street-cover

Part 2 — Naked Shorts — $75,000 For Cracking the Wall Street Cover-up
by RoryKearney | July 18, 2008 at 08:43 am | 531 views | 1 comment
http://www.nowpublic.com/world/part-2-naked-shorts-75-000-cracking-wall-street-cover-redux

Part 3 — Naked Shorts — $75,000 For Cracking the Wall Street Cover-up REDUX
by by RoryKearney | July 19, 2008 at 06:32 am |1162 views | 3 comments
http://www.nowpublic.com/world/part-3-naked-shorts-75-000-cracking-wall-street-cover-redux

Part 4 — Naked Shorts — $75,000 For Cracking the Wall Street Cover-up REDUX
by RoryKearney | July 23, 2008 at 10:05 am | 550 views | add comment
http://www.nowpublic.com/world/part-4-naked-shorts-75-000-cracking-wall-street-cover-redux

Part 5 — Naked Shorts — $75,000 For Cracking the Wall Street Cover-up REDUX
by RoryKearney | July 23, 2008 at 10:05 am |1760 views | add comment
http://www.nowpublic.com/world/part-5-naked-shorts-75-000-cracking-wall-street-cover-redux

Part 6— Naked Shorts — $75,000 For Cracking the Wall Street Cover-up REDUX
by RoryKearney | July 26, 2008 at 08:03 am | 626 views | 2 comments
http://www.nowpublic.com/world/part-6-naked-shorts-75-000-cracking-wall-street-cover-redux

Part 7— Naked Shorts — $75,000 For Cracking the Wall Street Cover-up REDUX
by RoryKearney | July 29, 2008 at 08:13 pm | 1783 views | add comment
http://www.nowpublic.com/world/part-7-naked-shorts-75-000-cracking-wall-street-cover-redux

Part 8 — Naked Shorts — $75,000 For Cracking the Wall Street Cover-up REDUX
by RoryKearney | July 31, 2008 at 05:05 pm | 374 views | add comment
http://www.nowpublic.com/world/part-8-naked-shorts-75-000-cracking-wall-street-cover-redux

Part 9 — Naked Shorts — $75,000 For Cracking the Wall Street Cover-up REDUX
by RoryKearney | August 6, 2008 at 07:56 am | 350 views | add comment
http://www.nowpublic.com/world/part-9-naked-shorts-75-000-cracking-wall-street-cover-redux

Part 10 - Overstock CEO Patrick Byrne Carpet Bombs Wall Street & The Media on the Don Harrold Show (Video)
by RoryKearney | August 26, 2008 at 12:27 pm | 386 views | 2 comment
http://www.nowpublic.com/world/overstock-ceo-patrick-byrne-carpet-bombs-wall-street-media-don-harrold-show-video

Part 11- I AIN'T LEAVIN' TILL THEY THROW ME OUT!
by RoryKearney | August 28, 2008 at 03:16 pm | 409 views | 2 comments
http://www.nowpublic.com/world/i-aint-leavin-till-they-throw-me-out

Part 12 - Back To Back
by RoryKearney | August 29, 2008 at 12:21 pm | 412 views | 5 comments
http://www.nowpublic.com/world/12-back-back

Just Say Yes. The FDA Ties That Bind. A Saturday Morning Rant.
by RoryKearney | July 12, 2008 at 08:24 am | 245 views | add comment
http://www.nowpublic.com/health/just-say-yes-fda-ties-bind-saturday-morning-rant

Everything I write is my opinion. If I have made any factual errors, please notify me, and I will correct them.