How to contact your Congressional Representative and provide information to ask for him/her to send a letter to Congress to join with the 3 Representative who are calling for a hearing. At bottom is how to locate the phone, fax and email addresses of your Representative. This information is also on the CTL Ways To Help page.

Call your Representative and thank them for taking your call. Ask for the Health Staffer. Make sure you get their name. Remember to thank them at the end and to tell them you will follow up. It is best to contact the Health Staffer at your Representative’s Washington office for the most clout. (see below for contact info)

Tell them that Congressmen Mike Michaud (D-Maine), Dan Burton (R-Ind.) and Tim Ryan (D-Ohio) and several other Congressmen sent a letter to Congressman John Dingell requesting hearings to look into the role that conflicts of interest played in the FDA determination not to approve a safe and effective late stage prostate cancer treatment.

Tell them CaretoLive (direct them to the CareToLive website http://www.caretolive.com), are joined by A Right To Live http://ARightToLive.com, the Cancer Cure Coalition, Ustoo, Abigail Alliance, Prostate Health education network (PHEN) and others in support of the hearings.

Go to CareToLive website Ways To Help
http://caretolive.com/ways-to-help/

CONGRESSIONAL LETTER ASKING FOR A HEARING
http://caretolive.com/wp-content/uploads/2008/01/
congressional-hearing-letter1.pdf

Fax, email or snail mail the letter to your own Congressional Representative and ask them to join this action. Here are other documents you may send or compile your own list. There are additional articles on the Articles page and the Research page and About Us page etc.
Articles Page http://caretolive.com/articles
Research Page http://caretolive.com/research
About Us Page http://caretolive.com/about-us

Nature Biotechnology The regulator disapproves
http://www.nature.com/nbt/journal/v26/n1/full/nbt0108-1.html

THE ROAD TO PROVENGE APPROVAL by Thomas A. Farrington President and Founder PHEN Prostate Health Education Network
http://www.prostatehealthed.org/phen_Detail.php?News=673

Petition for the FDA to Reconsider the Failure to Approve Provenge filed 7/27/07 Docket # 2007P-0297
http://caretolive.com/caretolivepetition.pdf

Robbing Cancer Patients of Hope by Dr. Chuck Bennett 1/26/ 2007
http://www2.tbo.com/content/2007/dec/26/na-robbing-cancer-patients-of-hope/
?news-opinion-commentary

Three Lawmakers Give Terminal Cancer Patients Early Xmas Gift by Evelyn Pringle’s
http://www.lawyersandsettlements.com/articles/01723/provenge-fda.html

Flowchart showing The FDA Decision on Provenge: Who’s Who and Who’s Connected
http://caretolive.com/wp-content/uploads/2008/01/players_provenge_v2.pdf

FAQS

Tell them you are an advocate for late stage prostate cancer.

30,000 American men will die of prostate cancer this year. Since the delay over 8 months ago, more than 22,000 men have died without the option of Provenge.

1 in every 6 men will get prostate cancer in their lifetime.

Each year over 218,000 men are diagnosed with prostate cancer.

96,000 men will progress to late stage or Androgen Independent prostate cancer (AIPC).

Only one drug has been approved which showed some survival benefits in the treatment of late stage androgen independent prostate cancer in over 42 years ago. It is so toxic and disruptive that most men refuse it.

The Dendreon Corporation has created a treatment called Provenge, an immunotherapy, that has shown it increases survival. The FDA saw the survival, granted Provenge Fast-Track Status, and then called together a panel of 17 experts to advise them on whether Provenge should be approved. The panel did indeed advise them.

By a vote of 17-0 the panel told them that Provenge is safe. By a vote of 13-4 the panel told them that Provenge shows substantial evidence of efficacy. The FDA decided to go against the panel of experts and delayed approval, an unprecedented act given that there are no viable alternatives in a treatment that was voted so overwhelmingly positive which showed survival benefits.
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HOW TO FIND YOUR REPRESENTATIVE

Contact Your Elected Officials

by Zip Code: http://www.visi.com/juan/congress/index.html
by State: http://www.conservativeusa.org/mega-cong.htm

This page will have all of your Congressman’s contact info including his Washington office. Type in their name and then scroll down for contact info.
http://www.congresspedia.com

Call your Rep and ask for their Congressional Health Staffer.

Follow with emails and faxes.

If you can visit their office.

Ask them to join this action requesting a Congressional Hearing. Speak to the health staffer. Don’t take silence for an answer. Be persistent until your Representative commits to support this action. Ask for a reply. If not, WHY NOT! Keep at it. They work for you. We pay their salaries. Sometimes it takes 2, 3 for 4 emails, faxes, calls.

If this does not work contact your Representatives Chief of Staff. Copy the Chief of Staff on a follow up email to the staffer. To find the email address of the Chief of Staff, go to this website

http://www.congress.org/congressorg/home
After clicking on your Representatives name, click on staff members below your rep’s picture. The screen will have the Chief of staff’s name listed.

To email him/her enter:
name dot last name@mail.house.gov.
Example: Denzel.Washington@mail.house.gov

If all else fails email me, rk@CareToLive.com with your name, your Reps name, their Health Staffers name and their phone number and we will contact them to try to get them on board.

EVERYBODY PLEASE MAKE A NOISE!!

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Click and send an online form to Representative Dingell, Chairman of the Committee on Energy and Commerce in charge of the Committe on Health asking them to hold hearings.
http://energycommerce.house.gov/membios/contact_form.shtml

Here are the members of the Subcommittee on Health that would take up the investigation. Frank Pallone is Chairman.
You may also fax them at 202-225-2525.
http://energycommerce.house.gov/Subcommittees/health.shtml

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Here is our Citizens’ Petition with the FDA for them to Reconsider the Failure to Approve Provenge filed 7/27/07
http://caretolive.com/caretolivepetition.pdf

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Become A CareToLive Member
http://caretolive.com/join-us/

Donate to the cause!

http://caretolive.com/donations/

Thanks For Your Help!

Popularity: 34%

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)

Popularity: 35%

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.

Popularity: 26%