The Sixth Circuit Court in Cincinnati, Ohio has granted the request of CareToLive to present oral argument in Appeal No. 07-4465 which is the appeal of the Southern District of Ohio Court decision (case # 07-729).

Oral arguments will be heard on July 29th at 1:30 pm at the Potter Stewart United States Court House, 100 East Fifth St., Cincinnati, Ohio.

Argument will be before a three judge panel. The identity of the three judge panel will not be identified until two weeks before the oral argument date.

Also, Thanks to all the participants that helped make the first ever Coast to Coast prostate cancer demonstrations a huge success!

Continue Reading CareToLive v. FDA — Sixth Circuit Court Grants Oral Argument in Appeal! »

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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 Continue Reading Denial is a River of Blood at the FDA »

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Read/Download Richard Ripp Rockville Gazette Ad richardrippgazettecolor.pdf

(click to enlarge) (available to print as a full page poster on the protest page)

Richard was featured in our Rockville/ Bethesda / Chevy Chase Gazette Ad campaign in Week #6. We so appreciate his standing up to help shed light on the Provenge fiasco and do his small part to help raise awareness of the terrible decisions that are being made at the FDA. We will miss Richard very much. Our hearts go out to his family and friends for sharing Richard with us for a little while. He was truly a great American, who stood up for the things he believed in, right up until the end.

Richard Ripp’s funeral is being held Friday May 30, 2008. How fitting that we will get to remember him during our nationwide protests. Richard Ripps name needs to resonate from one Coast to the other as we express our extreme sorrow for him and the 30,000 men who are slated to die this year from prostate cancer while Provenge, an immunotherapy shown to be safe and effective, with 10 years of trials under it belt, along with an overwhelmingly favorable FDA Advisory Panel vote, lays and rots on the shelves, with no explanation or scientific reasoning from the FDA.

PLEASE HELP US GET PROVENGE TO OUR MEN NOW!

Please join us for our Nationwide Protest of the FDA On May 30th. See details here ctlnatlprotest9.pdf and also visit our rally page for additional details http://caretolive.com/rally/

Video of the 2007 Rally at the FDA http://www.youtube.com/watch?v=UqAx7uZAS90

We have to continue doing everything we can to get Provenge to our men who are running out of hope and time. Please join with us in raising awareness for this very important issue and if you can, come out on May 30 to raise your voice to get Provenge Approved NOW!

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Please join us for our Nationwide Protest of the FDA On May 30th. See details here ctlnatlprotest9.pdf and also visit our rally page for additional details http://caretolive.com/rally/

Video of the 2007 Rally at the FDA http://www.youtube.com/watch?v=UqAx7uZAS90

The FDA’s Cancer Chief Speaks Out by Catherine Arnst
In a discussion with BusinessWeek, Dr. Richard Pazdur talks about clinical trials, small biotechs, and anxious patients
http://www.businessweek.com/bwdaily/dnflash/content/
may2008/db20080521_549448.htm

Steve Walker of Abigail Alliance writes a rebuttal:

May 23rd, 2008 at 10:32 am

With respect to the following:

We cannot approve drugs on the basis of emotion, says Pazdur. We cannot make drugs available at the expense of lowering standards of approval. difficult to argue with that logic. But it’s not likely to make cancer patients, or oncology-focused drug companies, feel any better.

To those of us who have been listening to and, much more importantly, following the actions of Dr. Pazdur over the last 7 years, his response regarding “lowering approval standards” is the kind of classic, disingenuous and condescending misdirection he is renowned for among those who have to deal with him on material matters, like approval decisions for safe and effective drugs.

Continue Reading FDA Health Czar Richard Pazdur Needs to be Replaced - He Turned His Back on the Public’s Health »

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There was ample of evidence of survival benefit conferred by Provenge as a treatment in contrast to Dr. Pazdur’s statement: “Believe me, if there were a clear survival effect, the drug would be approved,”. In fact, Dr. Pazdur’s focus on the statistical flaws showed that the main problem in the FDA drug approval process as practiced by Dr. Pazdur is a slavish following of rigid statistical rules without properly factoring in clinical knowledge required to give meaning to such numerical data.

The irony is that FDA has a process to incorporate clinical knowledge into drug evaluation. Advisory Committees made up of world-class experts are often convened to discuss clinical data and provide advices to the FDA during the evaluation of drugs up for approval. The AC convened to consider Provenge voted 17-0 that the drug was safe and 13-4 that there was substantial evidence that it was effective. When Dr. Pazdur helped rejecting Provenge, he effectively ignored that body of knowledge. He showed himself to be not only a slave to simple statistical calculations but also one who cared little for the scientific process and the needs of desperate patients.

For Provenge, the clinical data were:

1. D9901, a phase 3 trial enrolling 127 patients, whose primary endpoint, Time To Progression, barely missed statistical significance with p-value .052 and Overall Survival was highly significant with p-value .01. The survival rates at three years were 1 in 3 for patients treated with Provenge compared to 1 in 9 for patients treated with placebo. Per several sensitivity analysis performed by the FDA statisticians themselves, this trial was well run, the data self-consistent and the survival benefit unlikely to be spurious.
2. D9902a, a smaller phase 3 trial enrolling 98 patients, missed statistical significance Continue Reading FDA’s Richard Pazdur Cares Little for the Scientific Process and the Needs of Desperate Patients »

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Week #7 Rockville/Bethesda/Chevy Chase Gazette Ad Campaign

Please visit the FDA Protest 5/30/08 page and help us spread the word. There is much that everyone can do to help raise awareness. Thanks. CareToLive

Read/Download Richard Wick Bethesda/Chevy Chase/Kensington Gazette Ad richardwickgazettead.pdf

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JOIN US

VISIT OUR RALLY 2008 PAGE. http://caretolive.com/rally/

HOPE TO SEE YOU AT THE RALLY!!

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On Wednesday, April 16th, we wanted to beat the Pope mobile and his crowd so we left early and arrived in Rockville at 4:30 AM. At 4:45 plenty of FDA people had already reported for work and the parking lot was 1/3 full. We decided to protest earlier than the 7 AM we had originally planned.

We went and grabbed some coffee and got our signs ready and started protesting at 5:45. We were able to give out our latest ad and some copies of the Rockville Gazette which the folks took inside the FDA Building.

We were able to raise some more awareness as we shouted things like:

Extra! Extra! Read all about it!
Another CareToLive member has died.
Read his son’s sad story in Today’s Rockville Gazette!
The FDA hasn’t responded to our Citizens Petition!
The FDA hasn’t turned over all the documents we requested under the Freedom Of Information Act!
This is an emergency, FDA!
83 Men Die every day in America from prostate cancer!
Help us out FDA!!

Click here to see the video!

A third CareToLive member joined us at 7 AM. The three of us handed out all of our copies of the ad, Continue Reading CareToLive Returns To Rockville »

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This is Week #3 of our “In Your Face” Rockville Gazette Advertising Campaign to raise awareness to the tragedy that is taking place in the prostate cancer community. While 83 men die every day of prostate cancer, the FDA sits on our Petition, and refuses to reverse their fatal decision to delay Provenge to the 30,000 men who might have benefitted from it, each year.

Continue Reading We’re Going Back To The FDA Tomorrow Wednesday 4/16/08 »

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CareToLive Ad Full Page Color 8.5 ” x 11″ (click here)

CareToLive Ad Full Page Black and White 8.5″ x 11″ (click here)

1/2 Page Rockville Gazette Newspaper Ad (Actual Size) 5.638″ x 11″ (click here)

Copy of this 4/2/08 Press Release (click here)

FOR IMMEDIATE RELEASE

ADVOCACY GROUP “CARE TO LIVE” BEGINS LATEST CAMPAIGN

CareToLive Continues To Enlighten the World to the Dastardly Deeds of the FDA

Starting today, Wednesday April 2, 2008, CareToLive has begun the process of placing weekly advertisements in the Rockville Gazette, in Rockville, Maryland. These ads will contain letters from patients, families of patients or physicians. New letters will appear each week until the FDA does the humane thing and approves Provenge for the patients. The letters will also be distributed by volunteers on the streets of Rockville and on the internet.

CareToLive highlights the FDA’s blatant refusal to allow access to Provenge to men who are dying from late stage prostate cancer.

The letters will be heartfelt appeals to the humanity of the FDA, who even now, after being provided with the evidence that the Provenge BLA process was corrupted, do nothing to remedy it.

The FDA continues to refuse to follow its own rules regarding Citizens’ Petitions and refuses to comply with the Freedom of Information Act. Eighty four (84) men die every day while the FDA argues it needs 20 more months to provide simple documents to CareToLive and more than 8 months have passed without action on the CareToLive Citizens’ Petition.

First the citizens of Rockville, the home of the FDA, will further awaken to the travesty that occurred in their town that resulted in the denial of Provenge to 26,000 AIPC patients who have since died. Next the world will know.

More at www.CareToLive.com.

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