Dear Colleague (ahem),

Now for the cover letter that accompanied that spurious paper.

These anonymous dolts are truly grasping at straws, alluding to fictional dreams of bloodshed and birth defects.

We are not about harming people. Au contraire. We want people to live longer with better quality of life.

If I were to mention Thalidomide, which caused birth defects in thousands of women, in the same sentence as the safe, non toxic, non invasive immunotherapy Provenge that helps men with prostate cancer add years to their lives, I would want to remain anonymous too.

Who are these physicians and scientists in favor of suffering and death?

Okay, okay, I will shut up and present the letter.

anonymous-misinformation-cover-letter.pdf

Our previous blog covered the bogus report making the rounds, falsely disparaging Provenge. (see blog below Provenge is Approved but the Lies Continue)

This further dispels that bogus report. Care To Live has learned,

Dendritic/other immune cells are extravascular, not in the blood. Removing less than 3% of immune system. If you check 3 weeks after apheresis, level of immune cells in blood is same as prior to apheresis.

The immune cell count calculation within the report appears to be wrong. Based on the article, the calculation discussed the immunodepletion of the cells within the blood. However, the majority of immune cells are in the TISSUE, and not just in the blood. Dendreon measured the immunodepletion 3 weeks into the trial and that was normalized.

Within the clinical trials no increase in infection was seen between placebo arm and Provenge arm. This suggests a normalized immune system.

The survival in the control arm was no different than historical normals for Prostate Cancer.

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A bogus 27 page paper is being aggressively sent around wall street, and the medical, scientific regulatory and legal community, asking people to contact the FDA and the CMS. The cover letter touts the nonsense that they are scared to voice their concerns publicly. Feigning their safety fears is the same ploy they used last time, hiring bodyguards, at the taxpayers expense, fabricating non-existent threats, while no police reports ever turned up. This time we are determined to get to the bottom of it.

provenge-approval-fud.pdf

Their poor argument about the Phase III trial is dispelled here by Provenge advocate Ocyan:

This was a serious piece of work to support an argument that Dr. Hussain put up during the 2007 AC meeting when she said that the placebo protocol might have been active and could hurt patients. At that time, she gave no explanation of how that could be the case. Now, the argument is that it is immuno-depletion.

The basic idea is that a large number of immune cells were taken from a patient in a leukapheresis procedure. If a patient was on the treatment arm, he would get most of them back on reinfusion. However, if a patient was on the control arm, he only got back less than a third of what was taken during the leukapheresis procedure. Therefore, the immune system of a placebo patient was suppressed. That is called immuno-depletion.

The immuno-depletion attack on Provenge goes like this. Because of immuno-depletion, Continue Reading Provenge Is Approved But The Lies Continue »

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FDA returned on April 8th to check up on CTL.

Hey FDA, any word on Provenge approval yet, or are you still using snow days as an excuse to deny the treatment to the men who so desperately need it.

You are welcome to our site anytime. We look forward to seeing you in person at our next demonstration, but until then, make yourself at home here.

Oh, and we are still awaiting a response to our letter to Josh Sharfstein. Could you remind him to give us a call?

Thanks Brenda!

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Dear FDA,

As you read this on your next visit here, why not just agree to meet with us in person.

Are you aware Ms. Midthun refused our request to meet with her?

Here is her reply:

 http://caretolive.com/2010-01-11/cber-responds-to-letter-from-caretolive/

If you are interested in how we feel and what we seek to accomplish, then PLEASE meet with us.

We are planning a demonstration at the FDA in front of your building as that is the only alternative left to get your attention. We are sure you will see that news here first….so until next time…..

We know you are watching us. What are you looking for? Better yet, what are you waiting for?

CareToLive set up this website in June 2007. It was an information site for people protesting the FDA’s poor decision to delay getting Provenge, a safe and effective, non-toxic immunotherapy for men with late stage prostate cancer. These men are dying in excruciating pain and have no other viable treatment option.

Provenge met the criteria for approval as it has proven survival, the gold standard for approval. A panel of FDA hand-picked experts voted Provenge safe, 17-0, and that it demonstrated substantial evidence of efficacy, 13-4.

CareToLive watched as people approached the last FDA Commissioner, Andrew Von Eschenbach, and asked him to reconsider the decision. They gave him some very good reasons. Mr. Von Eschenbach refused.  CareToLive incorporated, filed a Citizen’s Petition, and then a lawsuit, and challenged the FDA decision. CareToLive spelled out why Provenge was not given proper due process by the FDA when it processed the Biologic License Application (BLA).

In July 2007 the FDA visited this site. What was it looking for? It was very late at night, around 10:30. Who was at the FDA office and what were they looking for over here? Is that when they gathered to shred and delete documents in response to our lawsuit?

Here is a list for the past seven months when the FDA stopped by this website.

The FDA stopped by:
09/01/09
10/06/09 
10/23/09
10/28/09
11/23/09
12/04/09
12/28/09
12/29/09
12/30/09
01/03/10
01/19/10
01/20/10
01/21/10
02/25/10 
03/11/10
03/25/10

The NIH stopped by
12/02/09

Memorial Sloan-Kettering stopped by
12/04/09 
12/28/09 

Once again, what is the FDA looking for? More important, what is the FDA waiting for? If they read our blogs they saw the latest data presentation from Dendreon, the manufacturer of Provenge. It demonstrates the same safe profile and the survival advantage is better than anything available, by leaps and bounds. What are you waiting for FDA? Approve Provenge NOW!

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Senseless years of death and delay for late stage prostate cancer patients while FDA Honchos collect huge salaries, enjoying life to the fullest.

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

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

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

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

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

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

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

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

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

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

CareToLive is thrilled to proudly broadcast this great news.

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

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   On January 28, 2010 the Florida Bar recognized Kerry M. Donahue, CareToLive’s attorney extraordinaire, for his stellar pro bono efforts on behalf of prostate cancer patients.

“The Food and Drug Administration has lost its way”, said Mr. Donahue. “The FDA Advisory Committee advised the FDA to approve Provenge, a safe, effective, non-toxic immunotherapy for men with late stage prostate cancer, and then the FDA delayed it without a rational explanation.”

Kerry sprung into action. He wrote dozens of motions and briefs, spending hundreds of hours trying to right the wrong. Without his efforts, we at CareToLive believe that the FDA would have deferred to the chemo cartel, who never wanted Provenge to see the light of day. He brought enough exposure, to insure that Provenge gets a fair chance for licensure this time around.

The FDA knew the patients were staring death in the face since they granted Dendreon’s Provenge Fast Track Status and Priority Review. It then chose to ignore its handpicked Advisory Committee which voted Provenge safe by a vote of 17-0 and substantial evidence of efficacy, by a vote of 13-4.

Kerry was honored by the President of the Florida Bar, Jesse H. Diner, & the Chief Justice of the Supreme Court of Florida, Peggy A. Quince.

Recently the Acting Director of CBER, Karen Midthun, denied Kerry’s request for a meeting. Ms. Midthun said the reason was as follows: “However, FDA cannot discuss matters with respect to a pending BLA without the express authorization of the sponsor. Therefore, at this time, we respectfully decline your request for a meeting.”

This statement flies in the face of the fact that FDA leaked letters written by Howard Scher, Maha Hussain, and Thomas Fleming all of which were discussing “matters with respect to a pending BLA” which were released “without the express authorization of the sponsor.” FDA picks and chooses when it will violate its own regulations, in order to help its business and political relationships.

At the center of this case is Howard Scher, a SGE for FDA, who was leading trials for treatments in competition with Provenge at the time he sat on the Provenge Advisory Committee. One day later he started working on a letter with the help of NCI’s Alison Martin for the sole purpose of lobbying the FDA to stop Provenge. Scher knew the Advisory Committee vote was a problem for his competing trials, one of which NCI funded, so he sprang into action right away. CTL has documented Mr. Scher’s activities and financial concerns (see Sleepless in Asentar and CTL Writes Interim FDA Commissioner Frank Torti). The astonishing fact is FDA went along and helped Scher by leaking his letter as well as follow-up letters by Hussain and Fleming, all of which discussed matters with respect to a pending BLA.

The FDA then had its legal team block all efforts by Kerry to get the men access to Provenge. Over 80,000 men have died while we waited another 2.5 years for further results. Those results are now in and they confirmed that Provenge is safe and effective. We are still waiting while they drool over the data.

In the meantime Kerry is also fighting for the Freedom of Information data to prove how flawed the process was. They are stymying us again, at every turn. He is determined to bring more oversight and transparency to an agency that has run amuck.

Congratuations to Kerry for receiving the Florida Bar President’s Pro Bono Service Award for 2010. CTL and all the friends of CTL are very proud of you. You are the best that mankind has to offer.

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CareToLive’s continual pursuit of the infamous personal opinion Dr. Howard Scher offered to NCI’s Alison Martin, hit a brick wall again January 29th, when William H. Hall, the Director of the News Division of the Office of the Assistant Secretary for Public Affairs, voted against handing Scher’s email over to CareToLive as requested under the Freedom of Information Act. Mr. Hall made some outrageous claims. Mr. Hall writes:

“After review of the redacted language, I find that it reveals nothing about the FDA proceeding. Rather, the redacted language contains Dr. Scher’s private thoughts as expressed to a professional colleague.”

Mr. Hall went on to say, “[Y]ou believe that because Dr. Scher served in some official capacity, anything he may have said about Provenge is public information. Dr. Scher is not a government employee and he does not forfeit his right to have personal information and details of his life protected from public disclosure simply due to his service on a government committee. As mentioned above, the redacted language does not address the FDA’s decision.”

Mr. Hall’s full letter appears below.

CareToLive would like to point out Mr. Hall’s errors.

Dr. Scher was a government employee when he wrote his personal opinion to Alison Martin. Scher wrote it one day after he served on the Provenge Advisory Committee.

The evidence will show that Scher was already planning on supplementing, as well as contradicting his own opinions at the Advisory hearing, by drafting a follow up letter to the FDA with regards to Provenge. Scher frantically lobbied the FDA not to approve Provenge.

Prior to the Provenge Advisory Committee, Scher signed a waiver which stated he was a special Government employee:

http://caretolive.com/2007-4291-w-07-Sche-208r.pdf

In addition, in the case CTL vs. FDA, the Department of Justice stated Scher must be granted immunity since he is a government official.

http://www.caretolive.com/Ctlscherdismmotion.pdf

At Page 13

Drs. Pazdur and Sher must be granted qualified immunity in their individual capacities at this stage of the litigation on plaintiff’s claims that they violated the United States Constitution.

At Page 14

“Qualified immunity protects government officials performing discretionary functions from suit for damages as long as their conduct “does not violate clearly established statutory or constitutional rights of which a reasonable person would have known.” Harlow, 457 U.S. at 18–19. Qualified immunity “is an immunity from suit rather than a mere defense to liability.””

Mr. Hall emphasizes that the redacted language in Scher’s email did not address the FDA’s decision on Provenge. That misses the point that Scher was trying to influence the FDA’s decision as this email was sent prior to the FDA making its decision to delay the approval of Provenge.

It is clear that Scher was seeking information and assistance from NCI employee Alison Martin as to how best to understand the FDA process, so as to most effectively influence it, to get the result he desired.

http://caretolive.com/NCI-FOIA-Response.pdf

_______________________________________________________________________________________________________

——-Original Message——–

From: Howard Scher

To: Martin, Alison (NIH/NCI) [E]

Sent: Fri, Mar 30 21:14:28 2007

Subject: Re: With your blessings – will circulate to authors this week

What did you think of the ODAC?

——-Original Message——–

From: Martin, Alison (NIH/NCI) [E] [mail to:martina@ctep.nci.hih.gov]

Sent: Friday, March 30, 2007 9:49 PM

To: Scher, Howard I. / Medicine

Subject: Re: With your blessings – will circulate to authors this week

Couldn’t go but it is quite the buzz at NCI -  not sure we understand - not sure it meant it would be approved. You were there - please tell me if you were convinced.

——-Original Message——–

From: Scher, Howard

Sent: Saturday, March 31, 2007 8:49 AM

To: Martin, Alison (NIH/NCI) [E]

Subject:   [ PERSONAL INFORMATION WITHHELD ]

Body:  [ PERSONAL INFORMATION WITHHELD ]

Howard I. Scher, M.D.

D. Wayne Calloway Chair in Urologic Oncology

Department of Medicine
Sidney Kimmel Center for Prostate and Urologic Cancers

Memorial Sloan-Kettering C ancer Center

1275 York Ave.

New York, NY 10021

Tel; Administrative: 646-422-4323

Clinical: 646-422-4330

FAX: 212-988-0851

Email: Scher@mskcc.org

——-Original Message——–

From: Martin, Alison (NIH/NCI) [E] [mail to:martina@ctep.nci.hih.gov]

To: Scher, Howard I. / Medicine

Sent: Sat Mar 31  6:15:05 2007

Su bject: Re: With your blessings – will circulate to authors this week

Glad to hear letter is being drafted. If that division’s vote suggests it be considered for approval, I was wondering if it then could go to the ODA, which is more clinically savy, i.e., this is just a step in the process.

Here is Mr. Hall’s full letter:

DEPARTMENT OF HEALTH & HUMAN SERVICES

OFFICE OF THE SECRETARY

WASHINGTON, D.C. 20201

This is in response to your October 27, 2008, letter in which you appealed the National Institute of Health’s (NIH) decision to withhold email language between Dr. Howard Scher and Alison Martin, National Cancer Institute (NCI) regarding Dendreon Corporation’s Provenge cancer drug.

In your appeal you first state that Exemption 6 does not apply because the email exchange is not a “similar” file with the definition of the FOIA. However, the term is interpreted broadly and includes all information that applies to a particular individual. Because the email text at issue applies directly to Dr. Scher, it satisfies the threshold requirement. You further state that even if Exemption 6 applies, the redacted language is not personal privacy information about Dr. Scher and, consequently, he has no privacy interest in its content.

After review of the redacted language, I find that it reveals nothing about the FDA proceeding. Rather, the redacted language contains Dr. Scher’s private thoughts as expressed to a professional colleague.

You stated that you believe that because Dr. Scher served in some official capacity, anything he may have said about Provenge is public information. Dr. Scher is not a government employee and he does not forfeit his right to have personal information and details of his life protected from public disclosure simply due to his service on a government committee. As mentioned above, the redacted language does not address the FDA’s decision.

You assert that the public has a right to know why Provenge was not approved. This argument is not relevant to this FOIA request because the requested material does not shed light on the reason(s) why FDA did not approve the drug. NIH did release those portions of the email that did not constitute an unwarranted invasion of personal privacy even where the information did not shed light on the FDA process or any other government operation.

My review indicates that NIH properly withheld the personal comments unrelated to government operations under Exemption (b)(6) of the FOIA. Exemption (b)(6) permits the withholding of privacy information the release of which would constitute a clearly unwarranted invasion of personal privacy.

This letter constitutes the final decision of the Department in this matter. If you wish, you may seek judicial review in the district court of the United States in the district in which you reside, or your principal place of business, or in which the agency records are located, or the District of Columbia.

Sincerely,

William H. Hall

Director, News Division

Office of the Assistant Secretary

for Public Affairs

In conclusion, CareToLive is currently considering District Court action to compel disclosure. CTL believes this decision is completely contrary to the law as stated in the Freedom of Information Act and is currently exploring the opportunity to commence District Court action against the Department of Health & Human Services.

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On November 2, 2009 the Dendreon Corporation announced it had completed the submission of the amended Biologics License Application (BLA) for Provenge, also known as sipuleucel-T, to the U.S. Food and Drug Administration (FDA).Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC). When approved by the FDA, PROVENGE would represent the first product in the new therapeutic class known as active cellular immunotherapies.

By December 25, 2009, CareToLive expects to see FDA approve Provenge based on FDA’s response to CTL’s Citizens Petition.

Dendreon presented the original BLA to the FDA in March, 2007. The FDA granted it Fast Track Status and Priority Review. FDA then used our tax dollars to assemble a panel of experts to advise them at an Advisory Committee hearing. That panel stated Provenge is safe by a vote of 17-0 and that Provenge showed substantial evidence of efficacy by a vote of 13-4. Two weeks after that panel recommended approval, some conflicted doctors who were worried about competitive Phase II treatments they were working on and what investors thought while having their own investments riding on the final FDA decision, lobbied the FDA to delay approval. After three letters were leaked, which showed collusion with some doctors at NCI, FDA denied approval on May 8, 2007. Among the leaked letters was a statement by NCI saying it did not support Provenge, rather it had a robust portfolio which included support for the competitive Phase II treatments mentioned above.

Dendreon proceeded with its IMPACT trial. In October, 2008, an Independent Data Monitoring Committee reported that the interim data showed Provenge had a safe profile and a 20% survival advantage over placebo. The FDA stood idly by and ignored this data which supported the original BLA.

On April 14, 2009, Dendreon announced Provenge significantly prolongs survival in men with advanced prostate cancer. The final data showed once again a safe profile and the survival advantage was now at 22.5%. To put that in perspective, 96,000 men in the United States have advanced prostate cancer, 30,000 of them will die. 22.5% of 30,000 means 6,750 lives would be saved. The FDA continues to stand coldheartedly by.

CareToLive continues to challenge the FDA. It still seeks FOIA documents from NCI and FDA. A senior official at the FDA, Richard Pazdur, declared he deleted and shredded those documents. With men’s lives hanging in the balance, our government agencies should not be participating in such shenanigans. CTL will hold FDA to its words.

When FDA responded to the CTL Citizens Petition, it said three times it would expeditiously review the data. We are holding them to it.

http://caretolive.com/wp-content/uploads/2009/05/fda-response-to-citizens-petition.pdf

                                          FDA Statement To CTL On May 21, 2009

Page 1:
“We are committed to expeditiously reviewing the new information as soon as it is submitted. FDA shares the goal of approving new products, such as Provenge, as soon as they are shown to be safe and effective.”

Page 3:
“We look forward to receiving this information and are committed to expeditiously reviewing the new study data upon submission.”

Page 14:
“We remain committed to working with Dendreon to facilitate its activities in pursuit of licensure for Provenge. We look forward to receiving Dendreon’s amendment to its existing BLA so that we may review this information expeditiously.”

On page 13 of their response, FDA said this: “FDA shares the concerns raised by CTL regarding the need for treatment options for advanced prostate cancer. The agency has implemented programs designed to expedite the review and approval of promising new treatments for cancer and other life-threatening diseases, and continues to work to improve those programs.”

“FDA has deep sympathy for the plight of patients who have exhausted their treatment options, but Congress requires FDA to make approval decisions based solely upon scientific data.”

CareToLive tried to get Congress to investigate the shenanigans surrounding the FDA’s handling of the original Provenge BLA. All Congress had to do was drag Matt Herper from Forbes into the chambers and ask him about this:

“But right now, its stock is dangerous to buy, because its fate will be determined by unpredictable politics at the Food and Drug Administration, not the certainties of science.”

http://www.forbes.com/2007/04/20/prostate-dendreon-stock-biz-cx_mh_0420dendreon.html

In addition, Congress could have called in Allison Martin from NCI as she helped write one of the leaked letters, or Richard Pazdur, who was seen passing notes at the Advisory Committee hearing and was said to be ready to throw a tizzy fit if Provenge was approved back in May 2007.

Congress could have called in Howard Scher who was worried about Dendreon investors and competitive Phase II trials for treatments he was working on, investing in and advising others to invest in.

Congress should still investigate this travesty. Here is some more information that can put them on the right track:

http://www.deepcapture.com/michael-milken-60000-deaths-and-the-story-of-dendreon/

CTL expects FDA to right most of this by Christmas Day, 2009.

Hey FDA, get Provenge to the dying men! Right away! Right now!

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The NY Times just released an article showing what a great guy Richard Pazdur is. This caused me to revisit journalistic integrity. The reason I did that is because I am going to present some rather harsh information about Richard Pazdur that this NY Times reporter, Gardiner Harris, refused to address. It appears to me that this reporter is a friend of Pazdur and this precludes him from maintaining journalistic integrity. This NY Times reporter will insult patient advocates while standing up for a guy who is supposed to be the ultimate patient advocate, a doctor.

http://www.nytimes.com/2009/09/16/health/policy/16cancer.html?_r=1

The preamble for The Society of Professional Journalists states:

Members of the Society of Professional Journalists believe that public enlightenment is the forerunner of justice and the foundation of democracy. The duty of the journalist is to further those ends by seeking truth and providing a fair and comprehensive account of events and issues. Conscientious journalists from all media and specialties strive to serve the public with thoroughness and honesty.

Please note: Conscientious journalists from all media and specialties strive to serve the public with thoroughness and honesty. It does not say to serve government employees and, in particular, doctors who work for the FDA, a government agency.

On its website, the New York Time states:

For more than a century The New York Times Company has stood for quality, integrity and distinguished journalism.

Will it remain standing for quality, integrity and distinguished journalism? The NY Times says readers dissatisfied with a response or concerned about the paper’s journalistic integrity may reach the public editor at public@nytimes.com or (212) 556-7652.

As you read the article penned in favor of Richard Pazdur, while denouncing those who protested against him, notice what is left out rather than what is puffed in. Why didn’t Gardiner mention Provenge or ImClone, two big blemishes on Richard Pazdur’s resume? Richard Pazdur is a conflicted liar. We the people should not have to see our tax dollars go to such a manipulator who pretends to be a doctor. He wouldn’t know the Hippocratic Oath if you smacked him over the head with it.

A good way to test the character of a doctor is to watch how he or she reacts in an emergency room. People are rushed to emergency room for many life threatening problems. The good doctors and nurses spring into action trying everything they can to save a life. Richard Pazdur does not react that way. In 2002, he leaked inside FDA information, which Gardiner is correct to point out is against the law, to a powerful Bristol-Myers Squibb lobbyist so he could get it into the hands of Paul Goldberg, who just happens to share tables at conferences with Richard Pazdur and this NY Times reporter, Gardiner Harris. This kept an effective treatment from reaching dying patients.

In 2007, Richard Pazdur raised his ugly head again and stopped a safe and effective, non-evasive, non-toxic prostate cancer treatment called Provenge from reaching 96,000 eligible men. The men had no other option. They had a quick destiny with death. Paul Goldberg assisted Pazdur with his non-peer reviewed medical publication called the Cancer Letter. Together, they leaked three letters that were supposed to be confidential. Why didn’t Gardiner Harris include this in his article? Continue Reading IT’S ALWAYS GOOD TO HAVE FRIENDS IN THE NEWSPAPER BUSINESS »

Popularity: 17%