CareToLive vs. FDA update
No. 08-584

Title: CareToLive, Petitioner

v.

Andrew von Eschenbach, Commissioner, Food and Drug Administration
Docketed: November 3, 2008
Lower Ct: United States Court of Appeals for the Sixth Circuit
Case Nos.: (07-4465)
Decision Date: August 28, 2008

~~~Date~~~ ~~~~~~~Proceedings and Orders~~~~~~~~~~~~~~~~~~~~~

Oct 30 2008 Petition for a writ of certiorari filed. (Response due December 3, 2008)
Dec 3 2008 Waiver of right of respondent Andrew von Eschenbach, FDA Commissioner, to respond filed.
Dec 10 2008 DISTRIBUTED for Conference of January 9, 2009.

Certiorari is granted at the court’s discretion, with most applications refused. It may be used to review the constitutional decisions of state courts of last resort and federal decisions on any important matter, especially when the inferior courts are in disagreement.

In this case the inferior courts are not in agreement on whether the finality requirement of the Administrative Procedures Act (APA) is a jurisdictional requirement. The D.C Court says “no”, the Sixth Circuit Court of Appeals says “yes”.

The Supreme Court SHOULD decide who is right, the D.C Circuit or the Sixth Circuit on the question as to whether it’s a jurisdictional issue. Since the two courts are currently in conflict it makes Federal law unclear, something the Supreme Court can remedy by reviewing the case and deciding which Court is correct.

We believe the Sixth Circuits Court of Appeals decision affirming the Southern District of Ohio decision was legally incorrect. That is the heart of the matter.

As to timing of an answer whether they will grant cert this is the Supreme Courts site statement:

“Generally, if a case is considered at a Conference, viewers can expect that the disposition of a case will be announced on an Orders List that will be released at 10:00 a.m. the following Monday.”

The Conference date is January 9th so that makes a likely decision date of January 12th.

Is the DC case on appeal to the DC Circuit? If so, is it likely that the Supreme Court will wait for that decision to see if the DC circuit resolves the conflict?

No, the cases were already appealed and they found that the finality requirement of the APA was not jurisdictional and one case said that some discovery was allowed on the issue of finality.

Check out the writ here (http://caretolive.com/CareToLiveWrit1025.pdf) as it sets forth the arguments.

The two inferior circuits are in conflict.

Continue Reading CareToLive vs. FDA Update »

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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!

* * * * *

Here is a Video of the 2007 Rally

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

MAY 30, 2008 NATIONWIDE PROSTATE CANCER PROTEST

* * * * *

20% of 42,000 Lives = 8,400 Lives & Counting

Money is very important to most people yet nobody can measure how many dollars one life is worth. There is no amount of money, no matter how much, that is worth trading for one single life. If one life is so very valuable to one family, then how much are 8,400 lives worth?

Ever since the FDA delayed getting Provenge to men with late stage prostate cancer over 42,000 men have died. If they were on Provenge since May 2007, at least 20% would still be alive. That is over 8,400 men that would have benefited.

In other words the FDA would have approved Provenge if it saved 9,240 people, but because it only saved 8,400 people’s lives, they won’t let us have it. The bureacracy must be using artificial intelligence to come up with their faulty conclusion to delay. The FDA already told us the agency is too broken to keep up with the science.

There are currently 90,000 to 100,000 men with Androgen Independent Prostate Cancer (AIPC), or are hormone refractory. That’s 18,000 to 20,000 people. AT LEAST THEY COULD BE SAVED, according to interim data just released. Keep in mind that the final data will even be more impressive.

CareToLive has again written to Dr. Jesse Goodman, the Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). CareToLive sent Dr. Goodman a Citizens Petition on July 27, 2007, to reconsider the denial of a license for Provenge, an immunotherapy treatment for men with late stage prostate cancer. The petition was sent to the FDA over a year ago and as per Federal Regulation CareToLive should have received an answer within 180 days after receipt. We are still waiting.

Additional data for Provenge has recently been evaluated and has shown what we at CareToLive have been saying all along. Provenge is safe and Provenge shows a survival benefit. An outside firm has just confirmed that 20% of the men in the Provenge trials survived over placebo, due to the Provenge treatment. It is time for the FDA to grant approval, even if only conditional while more data is gathered, so that men with late stage prostate cancer can begin receiving Provenge NOW!

Link to CareToLive’s Citizen’s Petition http://caretolive.com/caretolivepetition.pdf

Here is the letter CareToLive sent to Dr. Jesse Goodman:

Jesse L. Goodman, M.D., M.P.H.
Director
Food and Drug Administration
Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville, MD 20852-1448

Re: Docket No. 2007P-0297/CP1

Dear Dr. Goodman,

I am requesting that the FDA reconsider our CareToLive Citizens Petition docket number 2007P-0297/CP1 filed in July 2007, concerning the FDA delay of Provenge licensure for men with late stage prostate cancer. To date we have never received a proper answer and have only received one letter from you, stating that our petition is still pending. Enclosed is additional data obtained from the Independent Data Monitoring Committee (IDMC) from the Interim look, proving that the survival is real. Provenge clearly demonstrated a 20% reduction in the risk of death in the Provenge arm relative to placebo.

My husband Mike Kearney and I both spoke to Paul Richards of the FDA Consumer Affairs CBER Department, whom your office directed us to. He is supposed to be working for Consumer Affairs but he obviously does not have the consumer in mind. Mr. Richards stated that he himself looked at the data and did not see the survival. This is shocking, seeing that even Dr. Maha Hussain, of “leaked letter” fame said at the meeting that she saw the survival. She wanted to make sure it could be attributed to Provenge. This additional IDMC data proves that the survival is indeed due to Provenge. Mr. Richards refused to answer our question as to whether Provenge is safe. The IDMC clearly states that Provenge is safe, and the FDA Advisory Commmitee voted unanimously that Provenge is safe, so that should not be an issue, despite Mr. Richards refusal to admit Provenge’s safety profile. Mr Richards told us that the minority panelists swayed the FDA decision to delay Provenge. Another of the minority panelists, Dr. Howard Scher, also of “leaked letter” infamy, had many undisclosed conflicts of interest, including running a competitior’s trial for prostate cancer with Novacea’s Asentar, a trial that was stopped midstream due to the high number of deaths, possibly caused by Dr. Scher’s trial design, which caused an abundance of toxicity to the poor patients enrolled.

Our Citizens Petition, which is also attached, addressed the shenanigans that took place during the FDA Provenge BLA process. The FDA correctly granted Provenge Fast Track Status and Priority Review since it is a treatment for a life threatening disease where no viable alternatives exist. Regardless of what took place in the past, in light of the corroborating scientific evidence seen at the Interim, it is time to to reconsider our Petition concerning the denial of a license for Provenge for men with late stage prostate cancer.

To date, over 42,000 men have died without the benefit of Provenge. A 20% improvement in survival means that more than 8000 of them might still be alive if given the right to fight for their lives. It is a travesty that the FDA, which is sworn to protect the public health, has instead ignored these men in their battle with prostate cancer.

The FDA can fix this by allowing the 96,000 men who are eligible for Provenge right now, the chance to fight for their lives. Please restore the American people’s faith in the FDA, and in light of the new data, honor that Fast Track Status and Priority Review. Please reconsider the CareToLive Citizens Petition to reconsider the denial of a license for Provenge. This is an emergency!

Thank you for your immediate consideration of this matter.

Very Respectfully,

Rory & Mike Kearney
CareToLive,
a not for profit corporation

Cc: Division of Dockets Management (HFA-305)
Paul Richards, FDA Consumer Affairs
Lanessa Hill, FDA Consumer Affairs
Stephen Ripley, FDA Consumer Affairs

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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

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