Correction: this is not the final response.

 http://caretolive.com/Pages%201%20to%2050%20CTL%20CMS%20docs%20041811

http://caretolive.com/Pages%2051%20to%20100%20CTL%20CMS%20docs%20041811

http://caretolive.com/Pages%20101%20to%20151%20CTL%20CMS%20docs%20041811

http://caretolive.com/Pages%20152%20to%20200%20CTL%20CMS%20docs%20041811

http://caretolive.com/Pages%20201%20to%20250%20CTL%20CMS%20docs%20041811

http://caretolive.com/Pages%20251%20to%20300%20CTL%20CMS%20docs%20041811

http://caretolive.com/CTL%20CMS%200418%20docs%20301-385

Popularity: 23%

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

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

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

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

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

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

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

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

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

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

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

Popularity: 22%

Today CTL received an interim response to its two previous FOIA request made to CMS. The documents were retrieved upon a search performed by Dr Louis Jacques. We received 258 pages of which 74 pages were redacted under claimed exemptions of FOIA (5 U.S.C. 552 (b)(2), (b)(5) and (b)(6)).

Although the pdf’s are not in 100% chronological order it is probably easiest to comprehend each of the 5 individual pdfs, from back to front.

1-cms-foia-0221.pdf

2-cms-foia-02211.pdf

3-cms-foia-02-21.pdf

4-cms-foia–02-21.pdf

5-cms-foia-0221.pdf

Popularity: 15%

Care To Live, a not for profit corporation, tried to work with the Centers for Medicare and Medicaid Services (CMS) to avoid litigation in regards to CTL’s two FOIA requests but CMS gave no response. CTL’s Attorney, Kerry M. Donahue, had sent this letter to CMS inquiring about the requests:

kerrydonahuecmsletter.pdf

Once CMS did not respond, Kerry commenced litigation on CTL’s behalf on December 10, 2010:

ctlcmslitigationfile.pdf

Read more below at Ed Silverman’s Pharmalot site

Now, The Provenge Activists Are Suing Medicare

Popularity: 14%

Care To Live Counsel Kerry M. Donahue sent a letter to the Centers for Medicaid and Medicare Services (CMS), as a final gesture to resolve the Freedom Of Information (FOIA) conflicts with their agency. However, if the the status quo remains, and we receive no response, Kerry has already started preparing litigation against them and will file on December 10, 2010, if they choose to go down that road.

(Click picture to enlarge. Download pdf here kerrydonahuecmsletter.pdf)

Popularity: 13%

The CMS completely embarrassed itself yesterday!

The Center for Medicaid Services (CMS) had its long awaited MEDCAC meeting. It was designed to provide guidance to CMS as to whether they should pay for Medicare coverage for patients to receive Provenge. However, much of the meeting was spent with the CMS chairman trying to justify this futile exercise over a newly FDA approved, immunotherapy treatment already helping thousands of men with prostate cancer.

Further evidence of government incompetence was seen up close and personal. The chair of the meeting had a clear agenda. It turns out that he is on the payroll of the health insurance companies, as a consultant for them, which could easily explain his bias. Early on he allowed the speakers to express themselves, but his tone change toward the end.  His bias was revealed in his grandiose effort to paint the picture he wanted, by leading and sometimes even badgering the presenters, and interjecting his own emphasis as desired. His frequent shouting of “aha” was disgraceful.

CMS continues to refuse to provide documents to Care To Live as required under the Freedom of Information Act (FOIA), as to why this nonsense of a meeting ever came to be called in the first place. Litigation on this issue seems inevitable.

One issue clearly presented is that black men will be disproportionately unable to obtain a timely treatment that may actually have a more significant survival benefit for them. Black men are much more likely to get prostate cancer, and Provenge works even better in this population. It is a travesty that to obtain Provenge earlier, when the chances for three year survival are better, you will need either supplemental insurance or money.

The presenters at the meeting, including Dendreon, Urologic Oncologists, patients, patient advocates and concerned individuals who have followed Dendreon through its 5 year battle to bring Provenge to market, understand Provenge far better than CMS ever will.

As predicted, there will be no long term ill effects to Provenge. This government debacle was a waste of both taxpayer money, and Dendreon’s time, money and energy…which would have been better spent solving the supply problems.

In other words Provenge, will be covered by Medicare as anticipated. This very expensive exercise turned out to be a complete waste of thousands of peoples time and resources, as well as the taxpayer’s money.

Too much bad government!

This process was an ill thought out travesty by a power hungry organization. Much of the CMS meeting seemed to be an effort by the CMS chair to justify their huge waste of time and taxpayer money, which only made them look more incompetent.

It caused short term harm to Dendreon, however if we look at the bigger picture, it helped bring more attention to Provenge, and its groundbreaking immunotherapy treatment for cancer, which has now become one of the most well known cancer treatments in the world…

Now, about those supply problems…….

Popularity: 13%

CareToLive (CTL) has been receiving Freedom Of Information Act (FOIA) responses pertaining to the Medicare (CMS) investigation of Provenge. CMS said it “received informal inquiries for a national coverage determination (NCD) for autologous cellular immunotherapy treatment of prostate cancer. This interest arose upon the recent FDA approval of the Sipuleucel T treatment regimen, marketed as Provenge®.”

CTL submitted several FOIA requests in an attempt to find out who is behind the June 30th CMS “informal inquiries” and the 27 page bogus report that was publicized shortly thereafter.

CTL has learned Dendreon approached the CBER division of FDA in regards to the immunodepletion argument. Here is what CBER told Dendreon as stated in the response to our FOIA request:

“[FDA is] aware of the concerns but we did not find any clinical evidence of decreased white blood cell counts in control patients following leukapheresis in the 9902B clinical studies.”

In addition, CTL found out that the e-mail which was blind CC’d to many folks on Wall Street promoting the bogus 27 page document was e-mailed to three doctors in the CBER division of FDA and was also sent to Howard Scher at Memorial Sloan-Kettering by a Jonathan White.

Since the e-mail address by Mr. White was from a home e-mail account, CBER redacted the address in their FOIA reply.

From: Jonathan White [redacted e-mail address]
Sent: Wednesday, July 14, 2010 8:24 PM
To: scherh@mskcc.org
Subject: Provenge Safety Concerns

BCC list: 500 members of the medical, scientific, regulatory, and legal communities.

Dear Colleague,

This document attached/at the following link…  —– the rest of that e-mail can be seen right here:

http://caretolive.com/wp-content/uploads/2010/07/anonymous-misinformation-cover-letter.pdf

CareToLive has learned the address from which this e-mail originated. It came from a gmail account. Here is how it appeared when it was sent to at least 500 people:

From: Jonathan White <jon.white.dndn@gmail.com>
Sent: Wednesday, July 14, 2010
Subject: Provenge Safety Concerns

To cover all of the bases, CTL sent a FOIA request to Agency for Healthcare Research & Quality (AHRQ) since a Dr. Jonathan White works there, but AHRQ has told CTL it was “unable to locate any records responsive to our request.”

CMS has given CTL a control number and a pin number but no further information. They claim they receive a lot of FOIA requests so they need time. We are on a first-in, first-out basis. CTL will continue to follow up on it until we get some answers.

CTL checked their site this morning for the status of our request.

www.cms.gov/FOIA/04b_CheckStatus.asp

General Information
Control Number: 071220107008 Date Received: 7/12/2010 Subject: Decision of CMS to initiate National Coverage Determination on prostate cancer immunotherapeutic agent (Provenge)
Status Information
Status of the Request: FOIA request referred to program office(s) for responsive records search, fee estimate, and direct reply to requester   Projected Date of Response: Undetermined   Date of Response: Not available at this time
Downloads
There are no Downloads
Related Links Inside CMS
There are no Related Links Inside CMS
Related Links Outside CMS
There are no Related Links Outside CMS

Page Last Modified: 08/25/2010 9:09:20 AM

Popularity: 37%

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!“

Popularity: 11%

CareToLive has just learned Alison Martin no longer works at NCI. Remember her? She helped Howie Scher write his leaked letter. She now works for the Melanoma Research Alliance. Check out their website. It will be fully up and running on August 19th.

http://www.melanomaresearchalliance.org/

This is a new organization found under the auspices (patronage; support; sponsorship) of the Michael Milken Institute. It intends to support ambitious and innovative projects from both individual scientists and research teams to develop novel diagnostic and therapeutic avenues relevant to pathways governing the behavior and clinical outcome of melanoma.

Skin cancer represents the most commonly diagnosed malignancy, surpassing lung, breast, colorectal and prostate cancer.
Melanoma is a type of skin cancer.
Even though it is rare, malignant melanoma is responsible for 75 % of all skin cancer related death cases

Meanwhile, back at the NCI ranch, we tried to pursue the missing gaps in the FOIA documents, namely, Scher’s “personal” e-mail. Under the rules, we can’t have his personal letter if it has his mother’s maiden name, his social security number, his phone number, home address, etc. Well what we learned is, this e-mail has his personal opinion. Did he say bad things about the Advisory Committee, its panelists, the patients who made public statements, CBER, Dendreon and Provenge? Did he brag how Asentar and GVAX and Abiraterone are better options? We want to know. Personal information and personal opinion are two different things, especially when that opinion influences a decision.

You can view the NCI FOIA documents here:

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

Well, NCI tells us that since Alison Martin no longer works there, and since Scher doesn’t work for NCI, they do not have to turn over the e-mail. Can you believe that? What Alison Martin did when she worked for NCI should be fair game. Our tax dollars paid for that “work”. And what Scher, the most conflicted doctor on the Advisory Committee panel, had to say is most relevant in why he fought so hard to stop Provenge from being approved. We are sure he didn’t ask Alison Martin her bra size because it appears she forwarded the e-mails to Howard Streicher. We will continue to pursue this.

Popularity: 21%

The Sixth Circuit Court in Cincinnati, Ohio has granted the request of CareToLive to present oral argument in Appeal No. 07-4465 which is the appeal of the Southern District of Ohio Court decision (case # 07-729).

Oral arguments will be heard on July 29th at 1:30 pm at the Potter Stewart United States Court House, 100 East Fifth St., Cincinnati, Ohio.

Argument will be before a three judge panel. The identity of the three judge panel will not be identified until two weeks before the oral argument date.

Also, Thanks to all the participants that helped make the first ever Coast to Coast prostate cancer demonstrations a huge success!

Continue Reading CareToLive v. FDA — Sixth Circuit Court Grants Oral Argument in Appeal! »

Popularity: 17%