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

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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! »

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Please join us for our Nationwide Protest of the FDA On May 30th. See details here ctlnatlprotest9.pdf and also visit our rally page for additional details http://caretolive.com/rally/ .

Video of the 2007 Rally at the FDA http://www.youtube.com/watch?v=UqAx7uZAS90

We are protesting the terrible decision to deny Ted Girgus and thousands of other men like him with end stage prostate cancer ted-girgus-ad1a.pdf

Ted’s Doctor wants Ted on Provenge NOW!

1 in 6 men get prostate cancer. 27,000 American men die from it every years. Provenge is an immunotherapy that harnesses the bodies healthy cells and retrains them to target the cancer.

On May 28, 2007, in an unprecedented and horrendous decision, the FDA decided to delay treatment to these men.We would like to take a few moments to remember two of our CareToLive members who have passed away since the FDA turned its back on the men without explanation or cause.

We tried to get Congress to hold hearings over the shenanigans that went on at the FDA that day, including conflicts of interest with competing drugs, “leaked letters” and the corruption that took place at the dysfunctional FDA.

Congressman John Dingell (Michigan) and Frank Pallone (New Jersey) decided against a Congressional hearing for all the wrong reasons. You can read their response to those calling for hearings.

They prefer to leave these men seeking Provenge in FDA purgatory. It is over a year since denial of Provenge licensure but the FDA claims the decision is not final, it is just a delay. Congress says they won’t hold hearings because the decision is still pending. Tell that to our Ted Girgus. 2/13/08.

Here is Dingell and Pallone’s passing the buck. micha001.pdfThree Congressmen, Mike Michaud (D) of Maine, Dan Burton (R) of Indiana, and Tim Ryan (D) of Ohio called for a congressional hearing into the conflicts of interest and what went wrong at the FDA causing the delay of Provenge. (click this link) Read the Congressional Letter calling for a Hearing 12/13/07.

It is over a year and so many of our members, like Ted Girgus, who is desperately seeking Provenge, could be on Provenge NOW, getting the benefits that people like Eduardo Garcia and Bruce Tower received, two men who participated in the Provenge trials and are both still around to tell.

Come on Congress. Come on FDA. Do the right thing. APPROVE PROVENGE NOW!

Support the ACCESS ACT CareToLive Member Stephen Study’s son writes about the passing of his fatherwho was never given the chance to receive Provenge“I’ll Never forgive the FDA for what they did to Dad” (click to read)part IIhttp://caretolive.com/wp-content/uploads/2008/04/caretoliverockvillegazette4ad-part-2web.pdf

Also please support the ACCESS ACT! http://www.pharmalot.com/2008/05/a-bill-for-experimental-meds-for-terminally-ill/

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4/16/08 The Care To Live Awareness Campaign in the Rockville Gazette, continues to confront the FDA to address our Petition for the FDA to Reconsider their decision to delay Provenge in what was an unprecedented action by them to delay a treatment in an end stage disease where no other options exist, despite the fact that Provenge was voted 17-0 Safe and 13-4 Efficacious by an FDA Advisory Panel.

Please email, print and fax our ads to help increase awareness of the Provenge Debacle so we may reverse this tragedy. It is over a year since the Advisory Panel was convened. 30,000 American men die each year of prostate cancer. 1 in 6 men will get prostate cancer in their lifetimes. We need better, safer treatments NOW! The FDA needs to address the needs of the men with end stage prostate cancer, and allow them access to the immunotherapy Provenge IMMEDIATELY!

Stephen H. Study Died without ever receiving Provenge. Shame on those individuals at the FDA responsible for this genocide. They are so concerned about selling men drugs to enhance their sex lives, and have completely ignored the real needs of our men, the approval of drugs that have prolonged survival. Some men who received Provenge in trials are alive 6 years longer.

Week #3 Color Ad caretoliverockvillegazettesstudyad3a.pdf

Week #3 Black & White Ad caretoliverockvillegazettesstudyad3abw.pdf

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WEEK #2

Week 2 Ad Color caretoliverockvillegazette2ad.pdf

Week 2 Ad Black & White caretoliverockvillegazette2adbw.pdf

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FIGHTING FOR THE RIGHTS OF THE MEN WITH PROSTATE CANCER THAT THE FDA, DR. HOWARD SCHER & DR. MAHA HUSSAIN COULD CARE LESS ABOUT.

excerpt:

The FDA, with the help of a slew of in house attorneys, has created a labyrinth of regulations, all designed to avoid oversight and minimize due process. One of the latest creations of the FDA is the Complete Response Letter (“CR”), which is a very important, yet still unseen document in this litigation. In the magical world of the FDA they have created a mechanism that Houdini would be proud of. They turned a functionally final decision, into a self declared non-final decision. The issuance of the CR letter, that essentially is believed to say come back and see us in one, two, three or more years, when, or if, you get more data, is no different in application or in function than an outright denial of the application, yet the FDA forces people to accept their contrived definition, which is that a “Complete Response” letter is not a “final response” or even a decision, and that there is still an ongoing process, as they might still approve the application sometime in the nebulous future. In Provenge’s case, the CR letter operates to the applicant, the dying patients, the patient’s families, and everyone else waiting for the treatment, as a complete denial. A CR letter is just the latest fiction created to avoid oversight. Continue Reading KERRY DOES IT AGAIN! OUR APPEAL REPLY IS FILED!! »

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CareToLive has received an answer from the FDA to our Complaint that the FDA has not been forthcoming with all of the Freedom of Information (FOI) documents that we requested and are entitled to under the Freedom of Information Act (FOIA). Our Attorney Kerry Donahue will attend a Pretrial Hearing on March 5, 2008.

CareToLive requested all documents, letters, emails and /or correspondence from the National Cancer Institute (NCI) to the FDA or those acting as advisors to the FDA, concerning the BLA filed by Dendreon Corporation for fast track appproval of Sipuleucel-T, known under its marketing name of Provenge between January 1, 2007 and May 30, 2007. We seek to understand the role that the NCI played with regards to the process that resulted in the non approval of Provenge on May 9, 2007. We also requested all information pertaining to the roles played by Dr. Scher, Dr. Hussain and Dr. Fleming including Alison Martin and anyone else at NCI in regards to the FDA decision or with those working with the FDA, as as Scher, Hussain and Fleming.

CareToLive also requested all letters written to the FDA or prepared by the FDA and purported to be from Dr. Scher, Dr. Hussain and Doctor Fleming between March 29, 2007 and April 30, 2oo7 regarding the BLA submitted for Provenge, including the envelope or other means of communication whereby the FDA received such letters and a copy af any record for those letters then being disclosed to any media or other persons or specifically a publication call “The Cancer Letter”, including the means of communication of the Cancer Letter of the Scher, Hussain and Fleming letter from the FDA or its employees to outside persons, publications or companies. Continue Reading FDA Responds to CareToLive Complaint for Violation of Freedom of Information Act »

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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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Biotechnology Nature — Pressure is mounting on the US Food and Drug Administration (FDA) to explain its decision to ignore an advisory committee’s positive recommendation for the cancer vaccine Provenge. (click this link for full article) Below is an excerpt.

In the coming weeks, it looks increasingly likely that the US Congress will launch an investigation into the circumstances behind the FDA’s decision last May to delay approval of Provenge, a recombinant therapeutic vaccine developed by Dendreon for use in terminally ill patients with androgen-independent prostate cancer. Cancer patients have been exasperated by the agency’s decision to ignore an advisory committee recommendation made in March, which gave the green light for full approval. The flip-flop came following the panel meeting, after FDA received three letters sharply critical of Provenge’s safety and efficacy, which were subsequently leaked to the press. With allegations of ‘dirty tricks’ by agency officials and undisclosed, potentially damaging corporate ties associated with at least one of the letter writers, the onus is now on the FDA to affirm the legitimacy and impartiality of its regulatory process.

_______________________________________________________

Congressmen Mike Michaud (D-Maine), Dan Burton (R-Ind.) and Tim Ryan (D-Ohio) are calling for a congressional hearing into what happened. We must continue to be vigilant and to contact our representatives in the Congress to keep the pressure on, and to demand a congressional hearing. Please fax your own Congressional Representative the letter and the Biotechnology Nature article, etc. and ask them to send a letter to Congress saying that they want to join in this action. Do not take no for an answer. It may require several phone calls, emails etc to your Representative. Ask to speak with the health staffer. Do not give up. Tens of thousands of lives hang in the balance each year until Provenge is approved.

Please contact us if you need further assistance, rk@CareToLive.com . We would like to see immunotherapy, whereby the immune system is strengthened to fight off the cancer cells, rather than the current system of killing our healthy cells along with our cancer cells indiscriminately, sometimes killing us during the process, one day be made available for breast, colon, lung cancer etc. We are tired of the chemo cartel’s stronghold on our cancer treatments. We want immunotherapy choices like Provenge, which has gone through extensive trials, and proved to be safe and effective and as well as prolonging life along with improving the quality of our lives, when there are no viable options. The FDA delay was unprecedented. CareToLive attorney Kerry Donahue is currently suing the dysfunctional FDA on our behalf to try to make this treatment available to the men who need it now.

CONGRESSIONAL LETTER ASKING FOR A HEARING (click here to download) Please fax this letter to your own congressional representatives and ask them to join this action.

An Easy Way To Contact Your Elected Officials - (click here) EVERY VOICE COUNTS!

Contact Your Elected Officials - Click Here

This link will take you right to a page to send a form to the committee

Here are the members of the subcommittee that would take up the investigation.
Please use this link to email them.
You may also fax them at 202-225-2525.

Please fax the Congressional Hearing letter to your own Congressional Representatives along with the Biotechnology Nature article (use link at top of blog) and ask them to join the action to call for a hearing into what went wrong with the safe and effective immunotherapy Provenge approval process at the FDA. Over 20,000 men have died without the benefit of Provenge since the delay. Tell them you want a full inquiry into the undisclosed conflicts of interest of the 2 panelists that “leaked” letters used to derail Provenge. How did these two “doctors” offset the 17 to 0 vote on safety and the 13 to 4 substantial evidence of efficacy vote. The FDA works for us and not the other way around. We Want Provenge approved and We Want It NOW! WE WANT ANSWERS! Here is the letter in full. Continue Reading FDA Under Pressure From Congress To Explain Provenge Delay »

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Now comes Plaintiff CareToLive, a not for profit corporation and advocacy group organized and incorporated under the laws of and in Ohio, and hereby asserts the following causes of action against the Defendant, Food and Drug Administration (FDA), commissioner Andrew von Eschenbach.

Complaint Against the FDA for Violation of Freedom of Information Act (click link)

CareToLive is asking the public to help get to the bottom of the Provenge debacle by joining Congressmen Mike Michaud of Maine, Dan Burton of Indiana, and Tim Ryan of Ohio, who are calling for a congressional hearing into what happened. Contact your elected officials to ask for a congressional hearing, visiting the CareToLive website, dig our blogs, and join in the battle.

30,000 American men will die each year (not to mention the rest of the world) without this safe and effective immunotherapy. 1 in 6 men will get prostate cancer int heir lifetime. The FDA’s delay of Provenge was unprecedented in a terminal disease with an overwhelmingly positive panel that showed survival advantages, where no other options exist. Only one treatment for prostate cancer has been approved in 42 years. Send a clear message to Congress, the dysfunctional FDA, Wall Street, and the Chemo Cartel that we want this nontoxic immunotherapy approved NOW! More than 10 years of trials have shown it increases survival. Some men are alive as long as 6 years.

CONGRESSIONAL LETTER ASKING FOR A HEARING  PDF (click here) Please fax this letter to your own congressional representatives and ask them to join this action. TIA

An Easy Way To Contact Your Elected Officials - (click here) EVERY VOICE COUNTS!

Continue Reading CareToLive Files Complaint Against FDA for Violation of Freedom of Information Act »

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