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%

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%

On July 28th, the Dendreon Corporation announced “the publication of data from the pivotal Phase 3 IMPACT study in the New England Journal of Medicine, showing that PROVENGE® sipuleucel-T) demonstrated a statistically significant improvement in overall survival compared to control in men with asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer (mCRPC).  The manuscript is published in the July 29, 2010 issue of the journal.”

“These results represent the beginning of a new era in the treatment of cancer, one in which a patient’s own immune system is harnessed to fight the disease,” said Philip Kantoff, M.D., lead author of the publication, co-principal investigator of IMPACT and Chief of the Division of Solid Tumor Oncology at the Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. “Furthermore, the magnitude of the survival benefit coupled with the side effect profile and short duration of therapy place PROVENGE as a new standard of care for men with asymptomatic or minimally symptomatic mCRPC.”

The New England Journal of Medicine (NEJM) also included an editorial in which three questions were raised.

Below Care To Live presents the answers to those questions.(click this link)>> Continue Reading Provenge Works & Costs the Same as Chemo & Comments by Bishop »

Popularity: 99%

As the comments on the Centers for Medicare & Medicaid Services (CMS) website concerning the coverage of Provenge continue to mount, some people inadvertently, and some deliberately, have submitted inaccurate information. Care To Live (CTL), with the help of two of our exceptional physician and scientist friends, Dr. Robert Rostock and Ocyan respectively, continue to set the record straight.

It remains the opinion of CTL, based on all sources of information and investigation, that the CMS review is not about coverage or non coverage of Provenge. It is about interpreting the label, and how much to require from physicians prior to granting reimbursement approval.

We believe that the CMS review could and should actually lead to more patients being covered rather than less.

The argument should not be about coverage vs. non-coverage it should be about how early in the treatment regime patients will qualify for on label use.

We believe that CMS is wrong in not being more specific in their PR release, as to the specific purposes of review. They themselves are responsible for the circus-like atmosphere they have created. They should immediately issue a clarifying statement on this topic. Again, they have no legal or medical basis to deny coverage.

Dr. Robert Rostock, a first-rate prostate cancer Radiation Oncologist, who is in the trenches as he fights each day to treat men with late stage prostate cancer, provided his expert opinion.

“The label does need to be clarified. The sad truth is that most patients are diagnosed with a bone scan when there is already significant pain. Continue Reading Setting the Record Straight »

Popularity: 100%