ctldecision.pdf

The court ruled,

“Appeal Denied”.

Kerry is very sorry we could not win this for the patients suffering with AIPC. “We will take the fight to the Supreme Court but we understand that this is not timely enough for many thousands of suffering men.”

We are unripe. We are in FDA limbo. We haven’t been denied a license, yet you can’t get Provenge, but it is not denied, just delayed a few years. To our fathers, husbands, sons and brothers who have passed away, it is as final as anything can get. The FDA needs to be disbanded and the patients rights given back to the patients and not the corporations, and “venture capitalists.”

Unconscionable!

We fight on!

Next Stop

Kerry Donahue, our lawyer extraordinaire, has incredible fortitude to pursue this fight on behalf of men with late stage prostate cancer. The Courts are passing this hot potato up the hill. Kerry has filed a lawsuit on behalf of CareToLive to try to get men with late stage prostate cancer access to Provenge, a safe, non toxic, non invasive immunotherapy. Somebody needs to get the ear of the right fat cats on the hill, exchange a few suitcases of cash, no, wait a minute, that would be illegal. We have men we love who need Provenge NOW! Approve it because it is the right thing for a civilized society to do. Visions of Soylent Green come to mind.

FEAR NOT!

MOTION TO THE SUPREME COURT TO REVIEW Coming Soon!

Kerry, We LOVE You. You are doing an incredible job. You stand among America’s finest. Your amazing work on behalf of men with late stage prostate cancer is unrivaled!

http://caretolive.com/lawsuit-news/

The courts are part of the system, pushing us aside, shutting off another route to redress. We will stay in their face. What choice do we have.

Ted needs Provenge NOW!

http://www.youtube.com/watch?v=6Q0uQAL_YDA

http://www.youtube.com/watch?v=UqAx7uZAS90

THE CAN CAN
http://www.jibjab.com/starring_you/receipt/2111682

Popularity: 1%

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: 6%

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

Popularity: 10%

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) »

Popularity: 9%

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

Popularity: 14%

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

Popularity: 15%

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

Popularity: 19%

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

Popularity: 27%

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/

Popularity: 28%

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! »

Popularity: 37%