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.

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If you haven’t yet had a chance to read the FOIA response from the National Cancer Institute, read it here.

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The poster “emrssf” did a very good job of conveying to everyone here the environment at the oral argument. While it is not entirely accurate or complete (he states at the beginning that he does not take shorthand and so it is not presented as entirely accurate) it is close to accurate and in fact it helps me to recall the chronology of events better than I could without it. While he was taking notes on what was being said I was focused on responding to the Judges questions and anticipating my next argument. So I cannot be entirely accurate or complete either.

Continue Reading Where it stands…CareToLive vs. FDA (long winded version) »

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http://www.pharmalot.com/2008/07/civil-servant-disobedience-a-critical-fda-site/

Excerpt

Civil Servant Disobedience: A Critical FDA Site
11 Comments
By Ed Silverman // July 18th, 2008 // 12:55 pm
A new web site called Thoreau-FDA.com has emerged that is highly critical of the agency and, in particular, FDA commish Andy von Eschenbach, who is accused of oppressing FDA employees and preventing them from doing their jobs. The site, which is anonmyously crafted, is allegedly the brainchild of an unknown number of current and former agency employees.
Their goal: “to intensify public scrutiny of FDA upper management’s efforts at ensuring public health protection in an increasingly complex global marketplace…and engage (Andy), his successors and FDA upper managers in a public question and answer dialog … to end the entrenched process flaws in FDA’s pre-approval drug review and post-approval regulatory enforcement systems.

* * * * *

http://www.thoreau-fda.com/letter.php

Customize this letter and tell Commissioner “Andy” (as he likes to be called) Von Eschenbach what you really think about the delay for over a year of the immunotherapy Provenge for the 30,000 American men who die of prostate cancer every year without any options(not to mention the rest of the men in the world)

GoTo Blog #5 Click here
Part 5 — Naked Shorts — $75,000 For Cracking the Wall Street Cover-up REDUX
http://www.nowpublic.com/world/part-5-naked-shorts-75-000-cracking-wall-street-cover-redux

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http://www.nowpublic.com/world/part-4-naked-shorts-75-000-
cracking-wall-street-cover-redux

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Kerry Donahue, Attorney CareToLive

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

The Sixth Circuit Court in Cincinnati, Ohio
Appeal No. 07-4465
Southern District of Ohio Court decision (case # 07-729)

Today the FDA sent a Federal Rule of Appellate procedure 28 letter to the Sixth District Court which you can review here.
caretolive-defs-rule-28j-letter-20080716.pdf

Our Counsel then filed a response seen here
ctlfdarule28-responsea.pdf

and his own Rule 28 letter with attachments, seen here
cctlfdarule28jlettera.pdf

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Senator Brownback (R-KS) and Congresswoman Watson (D-CA) have introduced the Access Act - the Access, Compassion, Care, and Ethics for Seriously Ill Patients Act.

The Access Act is gaining support from both sides of the aisle in congress and the senate. Several members of the Congressional BlackCaucus have just signed on. Help from the prostate cancer/Provenge community in adding more co-sponsors is NEEDED. Please write your representatives and senators to request their support of the Access Act.

Melody has created a prostate cancer advocates’ petition (link below) that will also be sent to The Hill. It would be great to get thousands of signatures. Please sign and pass along to everyone you know.

http://www.petitiononline.com/access2/petition.html

http://www.house.gov/apps/list/press/ca33_watson/20080521.html

http://brownback.senate.gov/pressapp/record.cfm?id=298216

Please Sign the Provenge Petition Too!

http://www.petitiononline.com/provenge/petition.html

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Pictures of May 30, 2008 Protest of the FDA decision to delay Provenge, a non invasive, non toxic immunotherapy for end stage prostate cancer, over a year ago http://caretolive.com/rally/

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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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