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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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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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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On Thursday, 1/17/08, CareToLive received a response to the CTL Citizens Petition filed on July 27, 2007.
Read the FDA response to the CareToLive petition for the FDA to reconsider the decision to delay the approval of the immunotherapy Provenge (click this link)

Today 1/23/08 CTL received a call back from the person at the FDA that had previously faxed us the response to the CTL Citizen Petition.

She indicated that she could not give any kind of timeline on the reconsideration of the failure to approve Provenge. She was asked who could and if anyone else at the FDA could elaborate on the short letter received by CTL from Jesse Goodman, or if anyone could pinpoint a time frame.

She was an extremely nice lady but we sensed that she had strict marching orders.

She stated that “there is a group of people actively reviewing the matter”.

She was asked if the group consisted entirely of people from CBER and she said she was not comfortable answering that.

She was asked if Jesse Goodman was one of the people involved in the group considering the Petition. Again she indicated she was not able to confirm or deny that.

After a few similar type of questions it was sensed that she was very uncomfortable and CTL stated to her that we understood she was in a tough spot and understood that she was not able to tell us more. With that she was thankful.

CTL is sure she was told exactly what to say and not to deviate from what she was specifically told to disclose.

READ OUR PETITION HERE
Petition for the FDA to Reconsider the Failure to Approve Provenge (click this link)

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On Thursday, 1/17/08, CareToLive received a response to the CTL Citizens Petition filed on July 27, 2007.

Read the FDA response to the CareToLive petition for the FDA to reconsider the decision to delay the approval of the immunotherapy Provenge (click this link)

The response was from Jesse L. Goodman at CBER who we believe and hope is a friend to our cause and who we hope would also like to see Provenge approved.

The letter in substance stated:

“In your citizen petition you request the Commissioner of Food and Drugs to reconsider FDA’s failure to grant a biologics license application for Provenge…We are still considering your request and supporting information stated in your citizen petition….we will respond to your petition as soon as we have reached a decision on your request”.

I have a call into CBER to try and find out more about the meaning of the response and will advise if and when I know more.

While the letter might be an attempt to qualify as a response that satisfies 21 CFR(e)(2), it does not satisfy it in my opinion. Below are the parameters that the response must contain are containd in (iii) below, which this response does not contain.

2) Except as provided in paragraph (e)(4) of this section, the Commissioner shall furnish a response to each petitioner within 180 days of receipt of the petition. The response will either:

(i) Approve the petition, in which case the Commissioner shall concurrently take appropriate action (e.g., publication of a Federal Register notice) implementing the approval;

(ii) Deny the petition; or

(iii) Provide a tentative response, indicating why the agency has been unable to reach a decision on the petition, e.g., because of the existence of other agency priorities, or a need for additional information. The tentative response may also indicate the likely ultimate agency response, and may specify when a final response may be furnished.

While CTL is happy to report that the petition was not denied and is still being actively considered, they are unhappy that the FDA did not grant the petition.

I have been instructed by CTL to find out if the delayed response is a legitimate and short delay or just a stalling tactic. Once I ascertain this, a decision will be made by CTL what further legal action they wish me to properly pursue on their behalf.

(Attorney, Kerry Donahue, is suing the FDA on behalf of CareToLive, a prostate cancer advocacy group, to gain immediate access to Provenge, an immunotherapy voted 17 to 0 safe and 13 to 4 substantial evidence of efficacy and then delayed in an unprecedented act by the dysfunctional FDA for a treatment voted so overwhelmingly safe and effective, that showed survival benefits, where no other viable options exist. CareToLive believes foul play was afoot, as 2 of the naysayers had substantial undisclosed conflicts of interest and profited by seeing Provenge delayed.)

READ OUR PETITION HERE
Petition for the FDA to Reconsider the Failure to Approve Provenge
Tell the FDA what you really think about the delay of Provenge
Submit any comments to the CareToLive Citizen’t Petition plus attachments that might help our cause.

You may fax, email and/or snail mail them.

Please include:

Docket number 2007P-0297

Request to Reconsider the Failure to Approve Provenge

Fax 301-827-6870

email lyle.jaffe@fda.hhs.gov

Mail:
Lyle D. Jaffe
Division of Dockets Management
Food and Drug Administration, 5630 Fishers Lane
Room 1061 (HFA-305)
Rockville, MD, 20852

If you have any trouble you may call Lyle Jaffe at 301-827-6869.

PLEASE, if you had trouble getting your documents through, please use these contact points at the FDA and resend them.

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On a night in early April, 2007, the temperature was hanging around 35 degrees outside. It was considered good sleeping weather on the East Coast. But a particular doctor could not sleep. He tossed. He turned. His mind was still rapidly busy with the activities from a few days ago.

He could still see his fellow panelists sitting around the table in that hotel room in Gaithersburg, Maryland. He tried his best to influence them, to show them the flaws in the medical treatment they were evaluating. He kept pointing them to trial design problems, failed endpoints, and survival that surely could not have come from the agent.

Then the doctor’s gut suddenly felt that guilt-wrenching churn. Novacea and ProQuest had just popped into his head. If those panelists persuade the FDA to approve Provenge, he is finished. “Oh, no,” he thought, “and Schering-Plough will back out of that deal. I have to do something.”

Dr. Howard Scher sprang out of bed and headed to another room.

Continue Reading Sleepless in Asentar »

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