On behalf of CareToLive I must share with you the news that the United States Supreme Court has denied Cert to our case, which means they have chosen not to review the matter.

Such a ruling does not mean that our arguments were without merit, it merely means the Court has determined that it is not important enough for them to spend their judicial resources on at this particular time.

It is possible we could be before the Supreme Court again in the future for several reasons:

1) None of the merits on the underlying claims made by CareToLive, including the fact that the FDA acted capriciously when they denied approval to Provenge on May 8, 2007 have been decided. Those claims will become ripe when a “final decision” is made on Provenge. The original case was dismissed without prejudice in the lower Court which means we can again file a new complaint.

2) We also currently have pending in the Southern District of Ohio the FOIA Complaint that the FDA received a stay on until May. In May the case will become active again and the Court has already ordered the FDA to produce documents.

Also remember that CareToLive still has a duly filed Citizen Petition pending at the FDA. While Jesse Goodman and Andrew von Eschenbach have chosen to ignore it to date, each new commissioner, whether interim or finally appointed, will have the opportunity to review the petition if and when it comes to their attention (if it has not already). There is new hope with each new commissioner.

Also, a friend of CaretoLive filed an appeal at HHS of the NCI decision to redact portions of the Scher e-mail received in an earlier FOIA request, which we await a decision on.

While we are upset about the loss, because the hope was to speed Provenge to the patients who so badly need it as soon as possible, we are far from being done with the ongoing fight.

While much work is done behind the scenes, please know that not a single day goes by where CareToLive members, supporters and its many friends are not taking action in some manner or another to try to speed Provenge to market so that the patients can benefit by it and the new era of immunotherapy treatments for cancer can be ushered in. This is done by continuing to spread the word among our citizens, lobbying important people in Washington within and outside of Congress, working to gain the interest of and assist media and documentary film makers as well as “educating” the FDA (new and old). The delay of Provenge has needlessly delayed the advance of science and shortened the life of many late stage cancer patients who passed without the hope that Provenge might have brought to them, but their memories live on and with us, as we continue to seek justice and reform at the FDA.

We also extend a very special thanks to those at the Abigail Alliance, Accelerate Progress, PHEN, Cancer Cure Coalition and other advocacy groups that are constantly working for the cause and share similar goals to ours.

We are not alone in this fight and continue to ask everyone reading this to continue to spread the word of Provenge. If a weekend arrives and you have not shared the story with someone during that week then write a letter, mail it and tell the story to someone else.

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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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While the FDA continues to tow the untenable line they have chosen and while they continue to refuse to admit to their mistakes, much less take any action to fix them, Patients including CareToLive members continue to suffer.

This recent note was received from a very loved member of CareToLive:

“Just a note to thank everyone who has worked so hard over the past year and a half to oppose the FDA’s reckless disregard of cancer patients. I think it was Stalin who said: “A single death is a tragedy; a million deaths is a statistic.

That’s how I feel. Today my PSA is 300+ and doubling every 2 months. I did participate in a NCI Prostvac study in Bethesda. It slowed my disease for a while but I was recently dropped from the study due to disease progression in bone scans. The NCI doc recommended I get taxotere ASAP and did mention some past research suggesting following vaccine therapy with chemo enhances the effect of chemo. I’ll keep a happy thought, but what really maddens me was the study doc’s analysis that I simply had too much tumor mass for the vaccine treatments to overcome. I can only think of what might have been the outcome if I could have had Provenge treatments a year ago May when my PSA was moving through the 12 to 18 range. The latest interim report that a 20% survival improvement doesn’t quite cut it felt like a stake through the heart. Statistics rule.

Out of options, I’ll try the taxotere and hope for the best. I’m frustrated, tired, and out of energy for fighting the FDA, BUT I want you to know that I believe that God has a special place in heaven for you and your friends who put so much fight into representing people like me.”

We at CareToLive are humbled that a patient that is fighting for his very life would take the time to thank us. Tonight before you go to bed everyone say a prayer for all those men who are currently suffering from this dreaded disease.

It is for him and others like him and the patients of the future that we continue the fight. We just completed our writ for the Supreme Court which can be found here (Word document) or here (PDF document).

While I have no illusions about the chance that the Supreme Court will grant our writ of certiorari if by chance they did grant it then I am confident we would win it. The argument put forth is legally sound. The Court was wrong to dismiss the case on jurisdictional grounds.

Such a writ is basically a request that the Supreme Court review the matter. If they grant cert it would mean that they have agreed to review the case and invite the parties to submit briefs and make oral argument. If they deny cert then they do not review it.

Meanwhile, while CBER head Jesse Goodman has the power to reconsider Provenge based on the Citizens Petition filed by CareToLive he seemingly lacks the courage and the fortitude to do so, even though it is clearly the humane thing to do. Instead he chooses to ignore the citizens and he chooses not to respond to the numerous letters and e-mails sent to him from CareToLive since his January 2008 response that said: they are still actively considering the petition, but need more time. CBER, anyone home, hello, hello!

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