Matthew Herper, a writer for Forbes magazine and Forbes.com, has a biased, one-directional view of Dendreon’s Provenge, the first and only FDA-approved immunotherapeutic treatment for men with late stage prostate cancer. He continues to trip over his own feet in his attempts to lower the boom on Dendreon and Provenge. Over the past several years he even has attacked Care To Live, a prostate cancer patient advocacy group.

Mr. Herper could care less about the 30,000 men dying each year from an excruciatingly painful disease. He could care less about hurting a company financially that is attempting to cure not just prostate cancer, but many other forms of cancers as well. And he could care less about uncovering the malfeasance at the FDA Continue Reading Race To Undo The Cure »

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Although the Court of Appeals decision did not go our way in the case of CTL vs. FDA, whereby we are seeking documents Richard Pazdur declared he shredded and deleted, the Court was kind enough to inform us that our initial request was not specific enough. Therefore Care To Live has filed a new Freedom of Information Act (FOIA) request, which is on its way to the FDA’s Division of Freedom of Information as I post this.

CTL is asking for all documents and e-mails, among other things, sent to and from Richard Pazdur during the period October 1, 2006 through October 1, 2007, inclusive. CTL is quite specific this time in detailing exactly what we are asking them to search for.

The new FOIA request can be seen here:

ctl-cder-foia-request.pdf

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Today, CareToLive sent a FOIA request to:

Centers for Medicare & Medicaid Services
Office of Strategic Operations and Regulatory Affairs
Freedom of Information Group
Room N2-20-16
7500 Security Boulevard
Baltimore, Maryland 21244-1850

The request was sent via Express Mail and was also sent via their website,  http://www.cms.gov/foia/

Here is a copy of the request:    ctl-foia-request.pdf

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The Centers for Medicare and Medicaid Services (CMS) are currently seeking public comment as to whether coverage for Provenge should be provided to Medicare beneficiaries. CareToLive (CTL) asks all of its members and friends to file a public comment. CTL firmly believes coverage should be provided.

You can send your comment by simply clicking this link:    Public Comment

Here is my comment:

Commenter: Kearney, Mike
Title: Spokesperson for CareToLive
Organization: CareToLive, a not for profit corporation advocating for men with prostate cancer
Date: 07/02/2010

Comment:

I would like to respond to the questions Dr. Louis
Jacques, the director of the Coverage and Analysis
Group at the Medicare center, heard from people in
regards to Provenge. Dr. Jacques gave these
questions to Matthew Herper of Forbes Magazine.

“We’ve been getting questions from people,” says
Jacques. “‘Well, what’s up with Provenge? Is it a
drug? Is it a biologic? Is it something else? Does
it really work? It has been interesting to look at
the evidence around it.”

http://blogs.forbes.com/sciencebiz/2010/07/why-medicare-is-reviewing-provenge/?boxes=businesschannelsections

What’s up with Provenge is that it is medical
history. It is a paradigm shift for how we treat
cancer. No, it wouldn’t be considered a drug that
you would pop in your mouth, it is a biologic. In
fact, when it was approved by FDA, it was approved
by the staff of the Center for Biologics
Evaluation & Research (CBER). All the drugs are
approved by the staff of the Center for Drug
Evaluation & Research (CDER). Not sure what the
“Is it something else?” question is referring to.
But perhaps the best question, Dr. Jacques heard
is, “Does it really work?” Let’s look at the
evidence.

Three Phase 3 studies involving 737 patients were
Continue Reading The Centers for Medicare and Medicaid Services are requesting comments. »

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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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John Stossel from the Fox Business Network asks this very important question. Next he asks “Who owns your body?” You can watch his documentary as he weighs in on whether the government should have control over our bodies and the medications we take.

http://video.foxbusiness.com/v/4056081/who-owns-your-body/?playlist_id=87050

This touches all of us at CareToLive since we have been fighting the FDA for three years now for Provenge access for late stage prostate cancer patients. Stossel includes footage from the FDA Rally we held in Rockville, Maryland on September 18, 2007, with myself included at the Rockville Rally.

Stossel uses video of our beloved Bruce Tower. Bruce died while waiting for the FDA to approve Provenge, never having been able to receive it himself. He did participate in the Dendreon Trials, but he unfortunately only received a placebo, and not the actual immunotherapy.

The memory of Bruce, along with other CTL members, Stephen Study, John Fish, Howard Cassell, and Richard Ripp, makes us want to shout right along with John Stossel when he tells the FDA, “Why don’t you just butt out?”

The FDA can say it makes its decision based on science but we know that is all a bunch of baloney. Even Forbes writer, Matthew Herper, can tell you that. Remember this quote from his article back in April 2007:

Provenge’s fate “will be determined by unpredictable politics at the Food and Drug Administration, not the certainties of science.”

And then there was the testimony by Harry Markopolos before Congress during the Bernie Madoff investigation:

Congressman: Are you familiar with the concept of capture when you are talking about regulation? What is that? Do you know that concept?

Harry Markopolos: Yes. It’s basically when the regulator is in bed with the industry they purport to regulate and do not regulate the industry. In fact, they consider the industry the client, not the public citizens.

Congressman: And have you seen that in action.

Harry Markopolos: Yes. At the Food and Drug Administration and at the SEC.

Excerpt starts at 14:14  http://www.cnbc.com/id/15840232?video=1021435842

Care To Live is glad to hear Harry Markopolos has written a book called “No One Would Listen”  due out March 2nd.

In the meantime, check out John Stossel’s report and then write to your Senators and Congressmen and tell them to tell the FDA to butt out!

Hey, FDA, approve Provenge NOW!

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Today, CTL Attorney, Kerry M. Donahue, filed a reply in THE UNITED STATES COURT OF APPEALS FOR THE SIXTH CIRCUIT in response to the FDA’s refusal to search Richard Pazdur’s computer or the FDA servers for documents that satisfy our FOIA request.

Dr. Pazdur had made a Declaration stating he destroyed all said documents. Kerry states, “Merely asking the fox to count the chickens, without even allowing Plaintiff-Appellant to subject the answers of the fox to any sort of test of accuracy or truthfulness, was improper.”

You can read Kerry’s fine legal filing here: ctlfoiaappellantreplyeditedii030310pdf.pdf

CTL thanks Kerry, once again, for his hard work in this fight.

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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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When looking at The Freedom of Information Act [5 USCS § 552], notice what it states in Section 3:

B) Each agency shall make reasonable efforts to maintain its records in forms or formats that are reproducible for purposes of this section.

C) In responding under this paragraph to a request for records, an agency shall make reasonable efforts to search for the records in electronic  form or format, except when such efforts would significantly interfere with the operation of the agency’s automated information system.

(D) For purposes of this paragraph, the term “search” means to review, manually or by automated means, agency records for the purpose of locating those records which are responsive to a request.

The FDA responded to this by saying such a search for documents sent to and from Richard Pazdur would be complex. Then the FDA mistakenly told the court that such a request would be too costly, not realizing the requester pays for it.  After the search was completed, Richard Pazdur simply declared that he deleted and shredded the documents two years ago and CareToLive had to pay 40 cents for this complex search! 40 cents!

You can’t even purchase one of these for 40 cents!

Sadly, the Court in the Southern District of Ohio ruled in favor of FDA.

CareToLive’s fine attorney, Kerry M. Donahue, filed an appeal this past August and last night he filed our Appellate brief (Appellant’s brief) which is our written argument for the 6th Circuit Court of Appeals which they will review and then probably set up for oral argument.

The FDA (Appellee) has 15 days to file their response, but we would not be surprised if they get an extra 2 weeks after that if they need it.

You can read the brief here>>   ctlappealfoia11172009pdf.pdf

Here are some highlights:

“The Appelle has consistently argued that the Provenge matter is still an “ongoing process” so the destruction of documents regarding an ongoing process demands further inquiry.“

“Either way the FDA did not perform the “complex” search that it promised the Court and Appellant that it was conducting.”

“The search time incurred by the FDA CDER division FOIA office was so slight that it did not even register on the radar as a significant reportable/billable search time. That was the entire “complexity” of the search and response.”

“…the FDA told inquiring members of Congress that they did in fact conduct an internal investigation.”

” It does not cost the Defendant anything!“

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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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