Dear CMS,

Please consider first and foremost the men and the families who love them. These are the true beneficiaries of the Provenge Medicare coverage. To you they may be portrayed as points on a graph, but to us, each and every one of these men, matter greatly. We call them Dad, Grandpa, Son, Brother and Husband.

During the approval and now coverage process, we have experienced moments of extreme joy and devastating heartbreak. The almost five year old continuing Provenge saga, ongoing since Dendreon first filed the clinical portion of their Biologics License Application with the FDA in 2006, has ended up on your doorstep to make a coverage determination by June 30. So many of our men’s hopes and health are now riding on you.

We at Care To Live would like to make clear to CMS, FDA, NCI and all the other government agencies peripherally involved, that this process that Provenge and other treatments go through is much too long and much too arduous for the patients awaiting treatment. Serious consideration must be given to find ways to get these exciting new treatments to the patients who are without viable alternatives to death, sooner, including passage of the Abigail Alliance sponsored Access Act.

The FDA in particular, needs to help bring treatments for late stage disease, like late stage prostate cancer, to the patients earlier. During the Provenge approval process, the FDA and the NCI sadly acted as patient adversaries and barriers, instead of the bridge that we were promised.

Within CMS’ own walls, mistakes were made. We hope you will strive to avoid these careless actions in the future. Never should safety and efficacy, already put through a long and laborious FDA review process, ever be evaluated by your agency. If you decide to evaluate a treatment based upon your stated intentions, such as uniformity of coverage and classification of reimbursement, then you must make it very clear at the outset that this is your intention.

CMS lacks authority to re-evaluate data provided by the FDA for a treatment’s safety and efficacy. Such action is particularly ill conceived when it is a treatment for late stage cancer. Without fast action by Dendreon, patient advocates, and several Congressmen, many more men may have been denied treatment. Total catastrophe was averted but not before your agency came close to creating chaos as seen through the eyes of many patients, some of whom urged Congress to get involved.

This should never be allowed to happen again.

Despite what some have said in these comments and elsewhere, making late stage prostate cancer patients out to be sick old men, that is just plain wrong. Most are still active, vital people, with no outward signs of disease. Some are still quite young, and all, if left untreated, will die too early of a very painful disease.

We are not about to let that happen. Care To Live Continue Reading Care To Live Submits Moment of Silence to CMS »

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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

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CareToLive has been notified of its Courtroom and Judge assignment in case 09-4084 CareToLive v. FDA.

Wednesday, December 08, 2010, room 636 - 6th Floor East Courtroom, 9:00 A.M.

Before: Judge Boyce F. Martin Jr., Senior Judge Alan E. Norris and Judge Deborah L. Cook

Oral argument will be heard by this three judge panel on Wednesday, December 8, 2010 at 9:00 a.m. at the Potter Stewart U.S. Courthouse, 100 East Fifth St in Cincinnati, Ohio.

CTL’s filing in the Court of Appeals was 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

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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

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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

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CareToLive received word today from our counsel Kerry M. Donahue that the United States 6^th Circuit Court of Appeals has granted the request for oral argument in the case of CareToLive vs. FDA, Case No. 09-4084.

Oral argument will be heard by a three judge panel on Wednesday, December 8, 2010 at 9:00 a.m. at the Potter Stewart U.S. Courthouse, 100 East Fifth St in Cincinnati, Ohio.

CTL’s filing in the Court of Appeals was 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

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The Associated Press (AP) sent a story out over the wire this past Sunday which, sadly, was picked up by many newspapers and media outlets. It erroneously reported information about Provenge and showed a severe editorial bent by only interviewing doctors who have conflicts. Those conflicts should have been stated.

The writer, Marilynn Marchione, first raises eyebrows with the way she uses quotation marks. She quotes a patient who says he “would not spend that money” and then she jumps out of the quotations to give a reason why, “because the benefit doesn’t seem worth it.” Was it his reason or her reason? Later on she quotes him as saying “I feel very lucky”, so obviously he isn’t saying the benefit is not worth it.

She mixes up the price. Sure it is expensive. It took 15 years and billions of dollars to get it approved by the dysfunctional FDA. It should have been approved back in 2007. But the $93K is for a one time treatment, not $93K every year. Here is a great article showing how people like Marilynn Marchione can butcher the facts. Chemo still costs more because of hospital stays and more meds to treat its toxic side effects, not to mention the negative quality of life which Provenge does not have. But nobody is complaining about the expensive chemo. Why not?

http://www.minyanville.com/businessmarkets/articles/dendreon-provenge-cost-taxotere-sanofi-aventis/7/29/2010/id/29371?page=full

We find a lot of other things wrong with this deceiving article. Here’s what a friend of CTL has to say about it:

“First of all, the “adds 4 months survival, on average” statement is incorrect. Four months was the MEDIAN (not average) survival seen in the Phase III trial. That means that half the patients survived less than 4 months, half the patients survived more than 4 months. The median is the midpoint in the survival range, not the average survival. Most commentators and reporters get this wrong. I know of at least one patient who survived about 4 years and there are many who survived years rather than only months.

“Secondly, the $93,000 price is one-time, not an annual cost. There is no hospital stay with Provenge and, perhaps more importantly, there are very few side-effects. Those side effects are mainly cold-like and flu-like symtoms for a day or two and that’s it. A patient undergoes a procedure called leukophersis (essentially blood-drawing) in his doctor’s office and a few days later returns for infusion of the Provenge-treated cells. Perhaps 2-3 hours for the IV to complete. Provenge is the first FDA-approved cancer immunotherapy and a paradigm shift in the way prostate cancer is treated.

“I have followed Provenge closely since September 2003 and I am well acquainted with how it works, because there is a history of prostate cancer in my family.”

CareToLive also disagrees with the writer’s survival information with the fact that 67% of the patients were taken off placebo for ethical reasons and given Frovenge. Frovenge is a frozen variant of Provenge from the patient’s blood. Since they gave blood just like the Provenge patients, it was frozen with some Provenge so it could be given back to them later. The Frovenge patients survived a little longer so Provenge was actually competing against itself in these trials which were for the worst case scenarios.

We hope the AP sends out a correction and interviews people who do not have conflicts so the audience can hear both sides of the story.

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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 »

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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 »

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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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