Care To Live gets contacted often when things just don’t add up. When CMS initiated an investigation into whether or not it should cover Provenge, a suspicious e-mail was blind CC’d to 500 people. Many folks wrote to CTL inquiring about it. CTL started investigating the matter.

Some of those 500 people who were CC’d on the erroneous information work on Wall Street, some work at CMS, and others work at the FDA as confirmed in the response to our Freedom of Information Act request. One person who was included was none other than Dr. Howard Scher at Memorial Sloan-Kettering, who has never been a friend of Provenge.

Here is that e-mail:

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

And here is the bogus 27 page report (Note: this copy contains a two-page rebuttal by friends of CTL):

http://caretolive.com/wp-content/uploads/2010/07/provenge-approval-fud.pdf

A friend recently provided CTL with $500 to fund a reward for comprehensive information leading to the confirmed identification of the person, or persons, who sent the above e-mail and the 27 page report as part of an effort to disparage Provenge in the eyes of CMS as that agency prepares to review Provenge. Evidence is to be submitted to CTL Counsel Kerry Donahue at the address below, via Certified Mail. All submissions and eventual payout will be held confidential. In the case of duplicate inputs, the one with the most comprehensive suite of information and the earlier postmark will receive the reward. Only evidence submitted via Certified Mail will be considered. Be as comprehensive in the submission of information as possible to ensure full consideration of your first mailing. Also, be sure to include contact information (telephone/cellphone and address) so that Kerry can contact you, should that be necessary.

Here is the e-mail address from which the false information was sent:

From: Jonathan White <jon.white.dndn@gmail.com>
Sent: Wednesday, July 14, 2010 8:24 PM
To: scherh@mskcc.org
Subject: Provenge Safety Concerns

And here is the address to send any information via Certified Mail:

Kerry M. Donahue
Chief Counsel for CareToLive
6295 Emerald Parkway
Dublin, Ohio 43016

Popularity: 25%

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

Popularity: 37%

In case you missed it, the American Society of Clinical Oncologists (ASCO) wrote to CMS in support of Provenge. Here is what Dr. Allen Lichter, the CEO of ASCO, posted on the Medicare website:

Dear Drs. Paserchia and Fitterman:

On behalf of our 28,000 members who treat people
with cancer, the American Society of Clinical
Oncology (ASCO) is writing to express concern
about a recent action taken by the Centers for
Medicare & Medicaid Services (CMS).

On June 30, 2010, CMS opened an internally-
generated national coverage analysis (NCA) of
sipuleucel-T (Provenge®). Although we commend
CMS for taking steps to gather scientific
information about new cancer therapies, the
information provided by CMS regarding this NCA
lacks sufficient clarity regarding the purposes
underlying this action. In particular, we are
concerned that CMS may have plans to examine the
issue of whether to cover this therapy for its
FDA-approved indications. If that is the case,
this would be both counter-productive and ill-
advised. We believe that CMS is required by the
Social Security Act to cover drugs and biologics
for FDA-approved indications used in anticancer
chemotherapeutic regimens.

Since 1993, section 1861(t)(2)(A) of the Medicare
statute has provided a definition for drugs and
biologicals covered by the Medicare program that
explicitly includes those for use “in an
anticancer chemotherapeutic regimen for a
medically accepted indication. ” The statute
further defines “medically accepted indication”
to include “any use which has been approved by
the Food and Drug Administration” in 1861(t)(2)
(B). The statute thus clearly envisions that
Medicare coverage for cancer drugs will flow from
approval by FDA, and CMS has historically
followed this practice.

We urge CMS to withdraw the current NCA and look
for other means of communication to gather
information about this therapy, such as a
potential meeting with scientific experts to
address specific questions or a meeting of the
MedCAC (conducted outside of the context of an
NCA) to address specific questions. We
appreciate the longstanding and positive working
relationship that ASCO maintains with officials
throughout CMS, and we hope that you will
continue to look to ASCO and our members for
scientific and clinical expertise on this and
future issues.

Under any scenario, we urge CMS to provide clear
public statements regarding Medicare’s current
policies governing the coverage of this therapy
and to address the issue of how any potential
future changes in coverage policies at the local
or national levels could impact individuals who
might be mid-therapy. In practice, ambiguity and
uncertainty regarding coverage policies can act
as an unacceptable barrier to medically necessary
care.

Please do not hesitate to contact ASCO with any
scientific, clinical or administrative questions
involving cancer care provided in community-based
and other settings.

http://www.cms.gov/mcd/viewpubliccomments.asp?id=&cov_id=&state_id=&list_type=&goto=viewpubliccomment&nca_id=247

Popularity: 83%

Friends, Patients, and Families,

Do not worry about CMS coverage of Provenge. Provenge will be covered by Medicare for the FDA-approved indication. Of this, you have our absolute guarantee!

The supply issue is the real problem. However, we are expecting 36 more hoods to come on line in the very near future. This will allow more men to get access to Provenge right away.

Our current understanding of the CMS concern, is the use of Provenge on the entire prostate cancer patient population versus the HRPC/AIPC patient population. The issue appears to have been taken up by CMS in order to provide uniform local coverage of on label use.

Provenge is not being reviewed on the issue of whether Provenge is to be covered. It is now, and will continue to be covered.

Furthermore, CMS is neither interested in negotiating or cutting the reimbursement amount to Dendreon, nor for any other reason contrary to the best interest of the company and the patients it is striving to serve, or reviewing the reimbursement of the cost to the attending physicians. 

The Provenge treatment is a new paradigm, and local Medicare offices do not know how to classify and otherwise handle the reimbursement issue. Thus the need for the review and clarification.

Care To Live will continue to carefully monitor, and strenuously object to, any attempt by our government to interfere in the doctor patient relationship. If the recently filed Freedom of Information request sheds light on any other modus operandi, it will be shared here.

Any attempt by the government to use Dendreon as a test case, at the expense of the little biotech that could, will not be tolerated.

Any attempt by the FDA to use CMS as a means to control the issue of off label use, is also being watched carefully.

Popularity: 93%

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

Popularity: 87%