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Posts Tagged ‘prostate’

Provenge Works & Costs the Same as Chemo & Comments by Bishop

July 29th, 2010 | Posted by CTL

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%

Setting the Record Straight

July 25th, 2010 | Posted by CTL

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: 70%

CareToLive Strikes Back!

September 8th, 2008 | Posted by Mike Kearney

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%

CATEGORIES

WHATS GOING ON

This Is An Emergency!

We rallied outside the FDA building in Rockville, Maryland on September 18th. Now there are buses riding around Rockville and Washington, D.C., further protesting the shenanigans that took place inside the FDA building, as well as outside.

The FDA has gotten caught up with Wall Street. While it is supposed to be busy with evaluating food and drugs, its employees just can't keep their eyes off the money. So that is how decisions are being made these days.
WE'LL BE BACK

These people traveled from all across the country to protest outside the FDA Building in Rockville, Maryland. The FDA has stopped a safe and effective treatment from getting to men who need it now. The treatment is called Provenge and it treats men who have late stage prostate cancer.

The FDA appointed a panel of experts to help it decide on the safety and efficacy of Provenge. That panel voted 17-0 that Provenge was safe. And it voted 13-4 that Provenge showed substantial evidence it worked. And yet the FDA delayed it. Now it could be a year, a year and a half or it could be three years. It could be forever.

These people will keeping coming back to Rockville and they hope others will join them until the courts, the FDA, Congress or somebody does something about this travesty.