I will try to keep this brief to give a short overview of the situation. The facts are out there for anybody who wants to examine this further. You may also email us for further info.

http://youtube.com/watch?v=6Q0uQAL_YDA Video of Care To Live member Ted Girgus taken at our nationwide protest in Seattle. Ted has stage IV prostate cancer, that has metastacized to his bones. Ted and his doctor, want him on Provenge NOW! (More videos and photos coming soon)

Who We Are

Care To Live is a non profit group, who formed for the sole purpose of challenging the current status quo of the prostate cancer standard of care for end stage prostate cancer. We are trying to prod our fda, our government, our medical community, our advocacy groups, and our investment firms, into embracing the better science of immunotherapy, and to consider the people first, over their profits.

Neither the Board of Directors, nor any Care To Live member or friend, including our Attorney, Kerry Donahue, receive any salary. We are volunteers from around the world, who care about the health and well being of people everywhere and are concerned that there are better treatment options which are being overlooked. We saw the immunotherapy Provenge, and what it can do, and we feel it is our duty to stand up and fight for it. It is not easy to challenge and change the current entrenched cancer treatment options. Many of us are dedicated to stay at this until Provenge is approved. We want better, safer, more humane treatments, NOW!

We are funded by small contributions from people who want to promote Provenge and Immunotherapy as a standard of care in fighting cancer. We are joined by a few great advocacy groups who support us, such as Abigail-Alliance, A Right To Live, and the Cancer Cure Coalition. We did get some additional support from Us Too, but by and large we are mostly ignored by the advocacy groups. We can only surmise that they must perceive immunotherapy as a threat to their personal agendas.

The beauty of Care To Live is that they cannot buy our silence, and they know we will never sell out for any price. We are determined to see immunotherapy brought into the 21st century.

Dendreon, the company that discovered the immunotherapy Provenge’s targeted antigen cassette delivery system, also has similar treatments in their sight for breast, colon, ovarian, lung, kidney, and cervical cancers, etc.

Are there any treatments for end stage prostate cancer?

One new treatment has been approved by our FDA in 43 years. It is a chemotherapy, which is so toxic, that most men who understand the consequences of taking it, refuse to do so. Some men will die directly as a result of the treatment. If it is successful they can expect a life extension of an extra 2 1/2 months filled with extra pain and suffering due to the severe side effects of the chemotherapy, as the cancer and the chemotherapy ravish their bodies.

What is Provenge?

Provenge is a non invasive, non toxic, targeted immunotherapy which utilizes one’s healthy cells to fight end stage prostate cancer. It is administered in 3 infusions as an outpatient using one’s own white blood cells, to mount an attack against the cancer. Some men are living as long as 7 years after the three treatments they received 7 years prior. The side effects are usually limited to a day or two of fever and chills as your body builds up an immune response.

Can I get Provenge?

No.

Provenge went before the FDA over a year ago to apply for a license. They spent years consulting with the FDA who granted them fast track status and a rolling license submission. They were told by the FDA that the data was sufficient for them to file for the license. The FDA then assembled an Advisory Committee to advise them, at a cost of hundreds of thousands of dollars to the taxpayer. The Advisory Committee voted Provenge unanimously safe (17-0) and overwhelming that there is proof it is effective (13-4).

Two of the naysayers are oncologists, Dr. Howard I Scher, and Dr. Maha Hussain, and both are heavily invested in continuing the current toxic treatments and the managing of their side effects. One of them is also an investment advisor for Proquest Investments, which has substantial investments in a competitor. They both received conflict of interest waivers, and we have found out subsequently that they both failed to disclose many of their conflicts, such as being an investment advisor and extensive investment holdings. After the panel vote was over they wrote letters to the FDA telling them to deny licensure, and conspired with the FDA, and with Dr. Thomas R. Fleming, to leak the letters to the press to help stop approval. Although the letters were repudiated, they were used by the FDA as the basis for the denial. Their conflicts and the “leaked” letters, were never investigated.

Richard Pazdur’s CDER (radiation, chemotherapy) side of the FDA steamrolled Jesse Goodman’s CBER (biologics) division of the FDA where the Provenge decision resided. The dysfunctional FDA, with the blessing of Commissioner Andrew Von Eschenbach, effectively sentenced hundreds of thousands of men to an early death, without conscience or care. It is over a year and 83 men die every day of prostate cancer with no viable treatment options.

The FDA delayed licensure, not because of the science, or any other valid reason that we can ascertain. We are suing the FDA to find out the reason. Our lawsuit was dismissed and is currently pending appeal. The reason the Court dismissed it, was they said that the FDA has not denied the licensing of Provenge, they have merely delayed it, waiting for more data. Provenge has been through over 10 years of testing and there is plenty of data available. It is safe and effective. Tell our members who have died without ever receiving treatment that it is was just delayed, and not denied.

The FDA has refused to turn over documents we requested under the Freedom of Information Act. We believe these documents would prove there was a conspiracy within the FDA to stop Provenge from licensure.

We filed a Citizen’s Petition, (our only recourse under the FDA rules) almost a year ago with them, to reconsider their decision, and they have never properly responded.

We believe there is an ongoing cover up by some very rich and powerful political, financial, advocacy and media groups, who have no interest in finding better cures for cancer, but to simply keep the status quo in place. They do love securing funding and asking you and the government to send them more money, but remain suspiciously silent about the Provenge debacle. Many are reaping windfall profits off of the current system of treatment, management of side effects, and hospitalization, at a cost of billions of dollars to the taxpayers.

Why are they silent about the delay of a cancer treatment for an unmet need?

This is not friendly fire folks. Many of us believe that this is our planned destruction for their financial enrichment.

What We Want

We want medical reform. We want modern science to be embraced. We don’t care whose ox is gored in the process. We want access to Provenge for these men NOW! They can’t wait. This is an emergency!

What We Can Do

We have to continue educating the politicians, the medical profession, the advocacy groups and the “little people”. Most urologists aren’t even aware of Provenge. The press has been sent information thousands of times by Provenge advocates, but they have given us very limited coverage. We recently ran an ad campaign in the Rockville and Bethesda Gazette at a cost of thousands of dollars, to tell the FDA and the Medical Community that we are not happy. We should not have to pay for coverage. The press should be reporting on this tragedy every day. 83 Americans are dying every day without hope.

Some of the powerful media moguls, are also entrenched in profiting off of the present standard of care, and contributing large sums to The Prostate Cancer Foundation, run by convicted felon Michael Milken, the junk bond king, who has remained silent on the delay of Provenge. Why won’t they use some of their clout and connections to get Provenge to the men. Why does the Prostate Cancer Foundation have so many people on their staff that are tied in with Proquest Investments?

We just held nationwide protests in nine major U.S. cities and received almost no media coverage. We spent $1300 to send the details to every major news media outlet throughout the country, and most would not even mention our protests. We have been interviewed for tv and they have dropped the story. This is sadly, one of the greatest stories never told.

We have secured a filmmaker who also sees the value and the urgency of telling this story, and we are in the process of making a full length movie to help get the word out. If you would like to tell your story to him, please contact us. We are particularly seeking prostate cancer patients and their families who would like to be included in the movie.

A powerful hedge fund whispered in CNBC’s Mike Huckman’s ear many years ago, before it was even possible to know whether Provenge worked or not, that Provenge “doesn’t work”. We believe they then colluded with other investment funds to try to destroy Dendreon’s Provenge, planning to profit off of its demise.

“I remember sitting at a table at a rare Dendreon analyst meeting a few years ago and someone from a Connecticut hedge fund leaned over and whispered in my ear “It (Provenge) doesn’t work.” Mike Huckman

The Hour of Retribution is Upon Us.

These greedy sadists need to take their losses and lick their wounds and go away, because we are not going to accept their voodoo science anymore. We have to stand up and fight for Immuntherapy.

We are going to educate them one by one. We the healthy, have to get out and make a noise for the afflicted, ourselves, our loved ones, and our future generations. Families are genetically predisposed to prostate cancer. Many of the suffering don’t even know that a treatment exists that might help them. What good would it do them anyway, since they can’t get it.

It is our duty to bring this baby home. Not just for prostate cancer, for other cancers too. We have to pave the way for the other immunotherapies that they never want to see come to fruition. If not us, who will?

Watch this space as we mobilize and put together our next strategy for how we can all move this forward together.

Thanks for stopping by. Please come back soon.

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Tags: AIPC, Allison Martin, Brachytherapy, Cancer Vaccine, Care To Live, CareToLive, Chemotherapy, commissioner Andrew Von Eschenbach, Dendreon, FDA, foia, Freedom of Information Act, hormone refractory, Howard Scher, Immunotherapy, Jesse Goodman flubs it, maha hussain, Michael Milken sadly remains silent, Mike Milken, oncologist, Prostate Cancer, Prostate Gland, Prostatectomy, provenge, Richard Pazdur, Rick Pazdur, Robotic Surgery, Ted Girgus, The Prostate Cancer Foundation stays silent, Thomas R Fleming

This entry was posted on Sunday, June 1st, 2008 at 10:40 am and is filed under The Cause, The Dysfunctional FDA. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.