Dec. 10, 2008
Download: http://www.patientpower.info/Audio/webcast/
SCCA121008.mp3

Stream: http://www.patientpower.info/Audio/webcast/SCCA121008.mp3

P2site: http://www.patientpower.info/listendatedetails.asp?showid=
SCCA121008&Date=12&Yr=2008

Help Spread the Word.

Video of Ted Girgus who has late stage prostate cancer at a rally earlier this year in Seattle Washington. Ted is desperate and has been waiting YEARS for Provenge approval.

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

Popularity: 5%

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.

Popularity: 5%

It’s the Citizens that the currently unfriendly FDA are there to serve, a fact long forgotten by the current FDA. Also, TIMELY access to innovative new treatments for patients with late stage disease where there are no good alternative treatments available, which was important enough to encompass within the revised FDA mission statement, must be a priority. That mission was not accomplished under our current FDA chief.

Popularity: 6%

Tonight Ted Girgus to discuss Prostate Cancer and Provenge on Andrew Schorr’s Patient Power 9 PM EDT, 6 PM PDT

http://www.patientpower.info/webcastdetails.asp?dateid=
12/10/2008&webcastid=SCCA121008

If you have any questions you would like answered please
Email questions to: questions@patientpower.info

and help spread the word

Video of Ted Girgus who has late stage prostate cancer and is desperately waiting for the past several years for Provenge approval.

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

12/10/2008

6:00 - 7:00 pm PST

9PM EDT
Navigating Dilemmas Posed by Prostate Cancer Treatment Options
Live from (6:00 - 7:00 pm PST) Pacific. Check back for a link to the live program.

Treatment for localized prostate cancer carries with it not only issues of cancer control, but significant impact on health related quality of life. Measurement of cancer control and HRQOL outcomes is yet to be fully explored by the medical community. In this webcast, join Dr. Bruce Dalkin as we focus on how to measure cancer control in an optimal fashion and .

Guests:
Bruce Dalkin, M.D., Urologic Oncologist, Seattle Cancer Care Alliance
Ted Girgus, Prostate Cancer Patient
Peter Frishauf, Founder of Medscape

How to participate

Email questions to: questions@patientpower.info

Popularity: 7%

The media has it wrong, as usual.

When the media discusses a new commissioner they say the old FDA approved unsafe drugs. That is absolutely not a true portrayal of the problems at the FDA.

It’s that kind of irresponsible reporting that has caused Congress and much of America to be on the wrong page. It has also helped to create a risk adverse FDA.

Every time some approved drug later shows any safety issue, no matter how small, it makes the network news.

You never hear about the drugs that should be approved and are not, like Provenge.

If we continue to allow the dialogue to continue as it is, we are in danger that a new FDA will be even more risk adverse. Anyone whose hat is in the ring, and talks about the FDA becoming more safety conscious, does not get it!!

If President Elect Obama appoints Janet Woodcock to head the FDA, then his message of change has lost some of its meaning.

The next FDA commissioner needs to be more citizen friendly. He/she needs to be strong enough to make needed changes, changes which will be strongly resisted by the entrenched bureaucrats at the FDA, like Richard Pazdur.

Don’t believe the FDA is unfriendly? Try calling them and ask if you can be updated on the CareToLive Citizen Petition pending without decision since July 2007. They will treat you rudely!

The next commissioner needs to be more compassionate, more understanding of the issues faced by terminal patients and their families. They must understand that the U.S. is no longer the leader in health care in the world, and must want to change that. They must have a desire to bring about a more transparent and accountable FDA.

They need to be able to admit to agency mistakes (everybody makes them) and rather than try to bury the mistakes, they must allow the agency to learn from them, FIX THEM and grow. Often to do the right thing, an agency has to be willing to admit that it previously did the wrong thing, which the current administration absolutely will not do. Janet Woodcock has never admitted to any mistake, and if you ask her today, she will tell you that she does not see where the agency has made any mistakes.

The next commissioner must also be strong enough to keep Pazdur in his place so he does not go over to CBER, sabotage their Advisory Committees, and then bully and threaten the head of CBER to get his way when he is angry that he is not assigned the review of immunotherapies.

Andrew von Eschenbach has been weak and unwilling to do anything, other than to make empty promises and grandstanding speeches, that were never backed up by action. Most of all, the new commissioner needs to instill a sense of responsibility and humanity into the agency. The new commissioner must surround himself with employees who have a lick of common sense, and can use it when weighing risk/benefit. They need to admit that they currently are unable to assess innovative new treatments and actually listen to the AC experts they bring in, unbiased experts who should be without conflicts of interest.

Popularity: 14%

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!

Popularity: 18%

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

Popularity: 24%

CareToLive Reports Forbes Journalist to the SEC for “Rumor Mongering”

CareToLive, a not for profit corporation, wrote to Steve Forbes and his editors last Tuesday, asking them to investigate Matthew Herper and to consider relieving him of his duties. CareToLive cited Mr. Herper’s one-sided, rumor mongering story, which will appear in the September 15th issue of Forbes magazine. CareToLive presented the real story and tied it in to a Forbes welcoming screen, which displayed the following quote:

“Every being must desire happiness for himself.”

-Richard Price

CareToLive informed Steve Forbes that although Forbe’s use of the above quote is a nice idea, as long as people like Mr. Herper interfere with that desire for happiness, namely the happiness of the 96,000 men desiring a safe, non-toxic treatment for their late stage prostate cancer, it only remains a nice idea.

CareToLive relayed to Mr. Forbes that it should report Matthew Herper to the SEC for rumor mongering, in part because of his use of the word “lousy” when describing the Provenge data. Writing that the data were lousy demonstrated his own bias as the word lousy never appeared in any of the three leaked letters that he was referencing. SEC Chairman Christopher Cox said that the new enforcement action for rumor mongering cracks down on rumors that the disseminator knows to be false.

Furthermore, CareToLive informed Mr. Herper prior to the article that CareToLive was just coming into existence at the time of the Chicago rally and was not responsible for organizing it. Regardless, the Chicago rally was completely peaceful, and there were no threats or intimidation leveled from the demonstrators, all of whom conducted themselves in a dignified, professional manner.

CareToLive does not try to alienate or antagonize the many thousands of practicing oncologists. Our only problem has been with the five conflicted oncologists that worked to stop the Provenge license approval, namely Howard Scher, Maha Hussain, Thomas Fleming, Richard Pazdur and Alison Martin. CareToLive informed Mr. Forbes that there are prominent cancer doctors who firmly believe in the Provenge data, and await the approval of the treatment so they may administer it to their patients suffering from late stage prostate cancer.

CareToLive waited for a response from Forbes, without success, and two days later sent notice of the rumor mongering to Enforcement at the SEC. Once again CTL laid out the story, this time covering many of Scher’s conflicts, in particular the fact that Scher publicly admitted on page 3 of his leaked letter that he was leading a Phase III trial for a Provenge competitor. CareToLive believes that Scher should have excused himself from serving and voting on the Provenge Advisory Committee due to his lack of impartiality. CareToLive asked the SEC to investigate Dr. Scher’s conflicts and included the details of Scher’s ProQuest Investments Scientific Advisory position, and his relationship with Novacea.

When this article hits the newsstands any day now, and appears in subscribers’ mailboxes, or in waiting rooms of doctors and dentists, Mr. Herper will have achieved his goal of wrongly influencing the readers.

All of this was CC’d to Steve Forbes, his editors and Mr. Herper so they could see, once again, the other side of the story and to try to encourage Mr. Herper to be objective when he writes his next story on Dendreon and CareToLive. The SEC acknowledged receipt of the complaint.

CareToLive feels the article was in part penned by Mr. Herper out of revenge since CareToLive’s lawyer questioned Mr. Herper’s previous article. It is also CareToLive’s belief that Mr. Herper has never been fair to Provenge in his coverage of this prostate cancer immunotherapy and that Mr. Herper was the first to leak parts of Maha Hussain’s letter, the day before it was officially published.

For more information go to www.CareToLive.com

Popularity: 33%

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: 38%

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: 47%