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: 36%

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: 61%

As Care To Live anxiously waits for the FDA to approve Provenge any minute now, media coverage has picked up. More and more people are learning about this exciting prostate cancer treatment about to revolutionize the way cancer is treated.

It started on Sunday with the Seattle Times running a front page story.

http://seattletimes.nwsource.com/html/localnews/2011695773_dendreon25m.html

This article features a picture and story about retired Boeing manager Bob Feutz, and his wife Fran. Bob participated in a Provenge clinical trial in 2007 and shows no signs of relapse. That’s three years and still going strong.

Yesterday CBS’s The Early Show, ABC’s Good Morning America Show and CBS Evening News, all spread the news. Local affiliates also did reports yesterday.

On The Early Show, Harry Smith spoke to Dr. Jennifer Ashton. Dr. Ashton pointed out that Provenge does not have the toxicity of chemo and radiation and that the exciting thing about this vaccine is that many cancer experts look at it as the future in cancer treatment.

On Good Morning America, George Stephanopoulos interviewed Dr. Richard Besser. Dr. Besser said the hope is for other cancers, to use your own immune system to fight cancer. When Mr. Stephanopoulos asked about the price, Dr. Besser said it would run about $50K to $75K per course but additional studies hope to increase effectiveness and decrease the cost.

On CBS Evening News, Dr. Jon Lapook did the report on Provenge for Katie Couric. The footage contained a clip from the big protest Care To Live and others held outside the FDA Headquarters in Rockville, Maryland.

The Mean Vs. The Median

This science lingo has always confused people into thinking that Provenge only prolongs life 4.1 months. Nothing could be further from the truth.

Dr. Lapook interviewed Dr. Philip Kantoff of Dana-Farber Cancer Institute who said, Provenge works and it prolongs survival. When Dr. Lapook finished his report Katie asked him about the cost. She said considering there is only a little over four month survival, is the vaccine really worth it? Dr. Lapook reminded her Provenge was tested on the sickest patients first.

Luke Timmerman recently did a very good article about the pricing of Provenge. Jan Manarite from the Prostate Cancer Research Institute posted a good comment in regards to price:

PRICE - Keep in mind that Provenge will be a series of 3 pheresis treatments, given over about one month. Done. Most oncology treatments go on for months. Some indefinitely. That one unique variable will make the price of Provenge – in the big picture – end up costing less than many other oncology drugs.

You can read Luke’s article here: Continue Reading PROVENGE MAKING THE ROUNDS »

Popularity: 48%

Dear FDA,

As you read this on your next visit here, why not just agree to meet with us in person.

Are you aware Ms. Midthun refused our request to meet with her?

Here is her reply:

 http://caretolive.com/2010-01-11/cber-responds-to-letter-from-caretolive/

If you are interested in how we feel and what we seek to accomplish, then PLEASE meet with us.

We are planning a demonstration at the FDA in front of your building as that is the only alternative left to get your attention. We are sure you will see that news here first….so until next time…..

We know you are watching us. What are you looking for? Better yet, what are you waiting for?

CareToLive set up this website in June 2007. It was an information site for people protesting the FDA’s poor decision to delay getting Provenge, a safe and effective, non-toxic immunotherapy for men with late stage prostate cancer. These men are dying in excruciating pain and have no other viable treatment option.

Provenge met the criteria for approval as it has proven survival, the gold standard for approval. A panel of FDA hand-picked experts voted Provenge safe, 17-0, and that it demonstrated substantial evidence of efficacy, 13-4.

CareToLive watched as people approached the last FDA Commissioner, Andrew Von Eschenbach, and asked him to reconsider the decision. They gave him some very good reasons. Mr. Von Eschenbach refused.  CareToLive incorporated, filed a Citizen’s Petition, and then a lawsuit, and challenged the FDA decision. CareToLive spelled out why Provenge was not given proper due process by the FDA when it processed the Biologic License Application (BLA).

In July 2007 the FDA visited this site. What was it looking for? It was very late at night, around 10:30. Who was at the FDA office and what were they looking for over here? Is that when they gathered to shred and delete documents in response to our lawsuit?

Here is a list for the past seven months when the FDA stopped by this website.

The FDA stopped by:
09/01/09
10/06/09 
10/23/09
10/28/09
11/23/09
12/04/09
12/28/09
12/29/09
12/30/09
01/03/10
01/19/10
01/20/10
01/21/10
02/25/10 
03/11/10
03/25/10

The NIH stopped by
12/02/09

Memorial Sloan-Kettering stopped by
12/04/09 
12/28/09 

Once again, what is the FDA looking for? More important, what is the FDA waiting for? If they read our blogs they saw the latest data presentation from Dendreon, the manufacturer of Provenge. It demonstrates the same safe profile and the survival advantage is better than anything available, by leaps and bounds. What are you waiting for FDA? Approve Provenge NOW!

Popularity: 19%

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!

Popularity: 24%

DC (Deep Capture) crosses the Country from CA to NY in a land made title wave of corruption and collusion. No collusion of billionaires has ever perpetrated so much evil on the Citizens of the Country. They do it with a smile. Will anyone stop them?

What can you say about a few rich and powerful people who want to stop a company from fighting cancer? How does one get his or her head around such an idea? Cancer touches all of our lives.

When growing up, didn’t we all detest playing with cheaters? They didn’t mind breaking the rules and yet they were the first to search for rules when a play did not go their way. They were repugnant, repulsive people. They had to have things go their way, all the time.

And then these despicable people grew up. They brought their cheatful ways along with them, but then they raised the stakes. They included the almighty dollar. It wasn’t enough for them to win once in a while, it was important to win all the time because money motivated them to no end. They could care less if their dear mother or grandmother died, if it meant they made another buck. That is how grotesque these people are.

Lust is an insatiable condition. It can never be satisfied. The folks we speak of can’t get enough of the money they lust for. They need to get help. It is an addiction that needs to be treated. And once they resort to cheating and gaming the system, they need to go to jail, too.

These people and the darkness that shrouds them which threatens the very core of our being, is discussed in the Dendreon Story as presented by world class journalist, Mark Mitchell. Mark connects the dots and presents the case against these aforementioned heartless cheats who have really lost their way. Go to www.DeepCapture.com and read this amazing 15 Chapter story of how these people wanted to stop medical advancements against cancer, just so they could make a buck or win another game. Referees and rule enforcers couldn’t blow their whistles quick enough, or loud enough, to stop them in their tracks. Do we have anyone out there who can stop them and bring them to justice?

Popularity: 18%

CareToLive Reports Forbes Journalist to the SEC for “Rumor Mongering”

CareToLive, a not for profit corporation, wrote to Steve Forbes and his editors last Tuesday, asking them to investigate Matthew Herper and to consider relieving him of his duties. CareToLive cited Mr. Herper’s one-sided, rumor mongering story, which will appear in the September 15th issue of Forbes magazine. CareToLive presented the real story and tied it in to a Forbes welcoming screen, which displayed the following quote:

“Every being must desire happiness for himself.”

-Richard Price

CareToLive informed Steve Forbes that although Forbe’s use of the above quote is a nice idea, as long as people like Mr. Herper interfere with that desire for happiness, namely the happiness of the 96,000 men desiring a safe, non-toxic treatment for their late stage prostate cancer, it only remains a nice idea.

CareToLive relayed to Mr. Forbes that it should report Matthew Herper to the SEC for rumor mongering, in part because of his use of the word “lousy” when describing the Provenge data. Writing that the data were lousy demonstrated his own bias as the word lousy never appeared in any of the three leaked letters that he was referencing. SEC Chairman Christopher Cox said that the new enforcement action for rumor mongering cracks down on rumors that the disseminator knows to be false.

Furthermore, CareToLive informed Mr. Herper prior to the article that CareToLive was just coming into existence at the time of the Chicago rally and was not responsible for organizing it. Regardless, the Chicago rally was completely peaceful, and there were no threats or intimidation leveled from the demonstrators, all of whom conducted themselves in a dignified, professional manner.

CareToLive does not try to alienate or antagonize the many thousands of practicing oncologists. Our only problem has been with the five conflicted oncologists that worked to stop the Provenge license approval, namely Howard Scher, Maha Hussain, Thomas Fleming, Richard Pazdur and Alison Martin. CareToLive informed Mr. Forbes that there are prominent cancer doctors who firmly believe in the Provenge data, and await the approval of the treatment so they may administer it to their patients suffering from late stage prostate cancer.

CareToLive waited for a response from Forbes, without success, and two days later sent notice of the rumor mongering to Enforcement at the SEC. Once again CTL laid out the story, this time covering many of Scher’s conflicts, in particular the fact that Scher publicly admitted on page 3 of his leaked letter that he was leading a Phase III trial for a Provenge competitor. CareToLive believes that Scher should have excused himself from serving and voting on the Provenge Advisory Committee due to his lack of impartiality. CareToLive asked the SEC to investigate Dr. Scher’s conflicts and included the details of Scher’s ProQuest Investments Scientific Advisory position, and his relationship with Novacea.

When this article hits the newsstands any day now, and appears in subscribers’ mailboxes, or in waiting rooms of doctors and dentists, Mr. Herper will have achieved his goal of wrongly influencing the readers.

All of this was CC’d to Steve Forbes, his editors and Mr. Herper so they could see, once again, the other side of the story and to try to encourage Mr. Herper to be objective when he writes his next story on Dendreon and CareToLive. The SEC acknowledged receipt of the complaint.

CareToLive feels the article was in part penned by Mr. Herper out of revenge since CareToLive’s lawyer questioned Mr. Herper’s previous article. It is also CareToLive’s belief that Mr. Herper has never been fair to Provenge in his coverage of this prostate cancer immunotherapy and that Mr. Herper was the first to leak parts of Maha Hussain’s letter, the day before it was officially published.

For more information go to www.CareToLive.com

Popularity: 23%

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: 31%

Scrutinize FDA on Cancer Drugs

by Chuck Bennett.

Click this LINK to read the Editorial in the Milwaukee Journal-Sentinel Circulation 235,000.

So many doctors are kind, caring, compassionate people who don’t get the respect they deserve, that is, until you need one. This Chap is an example of the best of what medicine has to offer. I mean, we never remember them when we are well but they never forget all the suffering that they are exposed to on a daily basis.

Popularity: 12%

On a night in early April, 2007, the temperature was hanging around 35 degrees outside. It was considered good sleeping weather on the East Coast. But a particular doctor could not sleep. He tossed. He turned. His mind was still rapidly busy with the activities from a few days ago.

He could still see his fellow panelists sitting around the table in that hotel room in Gaithersburg, Maryland. He tried his best to influence them, to show them the flaws in the medical treatment they were evaluating. He kept pointing them to trial design problems, failed endpoints, and survival that surely could not have come from the agent.

Then the doctor’s gut suddenly felt that guilt-wrenching churn. Novacea and ProQuest had just popped into his head. If those panelists persuade the FDA to approve Provenge, he is finished. “Oh, no,” he thought, “and Schering-Plough will back out of that deal. I have to do something.”

Dr. Howard Scher sprang out of bed and headed to another room.

Continue Reading Sleepless in Asentar »

Popularity: 47%