Read and Leave Comments on our FDA CareToLive Citizens’ Petition Request to Reconsider the Failure to Approve Provenge >>

http://www.regulations.gov/search/search_results.jsp?css=0&N=0&Ntk=All&Ntx=mode+matchall&Ne=2+8+11+8053+8054+8098+8074+8066+8084+8055&Ntt=FDA-2007-P-0168-0011%20%20&sid=121682D41130

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!

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

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PLEASE Contact your Representatives and Senators and ask them to find out what the FDA is doing with our tax dollars. The FDA is supposed to look out for the public health, not enrich themselves by delaying treatments. Tell them, we want Provenge Approved NOW!

HOW TO FIND YOUR REPRESENTATIVE

Contact Your Elected Officials

by email http://www.conservativeusa.org/mega-cong.htm

by zipcode http://www.visi.com/juan/congress/index.html

If you go to the Congresspedia site http://www.Congresspedia.com and put your Representative’s name in the search box and scroll down and you will find all current contact information. Contact their Washington office as they have the most clout.

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Operation Accelerate Approval

TED GIRGUS NEEDS PROVENGE YESTERDAY!

The Provenge Impact trial showed a 38% 3-year survival rate!!

A 22.5% reduction in the risk of death!!

Mitchell Gold: “met its pre specified end points” “confirms results of previous studies” “data met criteria and specifications of Biologics License Application” “results were robust” “results were unambiguous and held up to multiple sensitivity analysis” “a clear hit on statistical significance”.

It is the first active immunotherapy to show a survival benefit in a phase 3 study. It is a tremendous accomplishment for the company and it means a tremendous amount for prostate cancer patients across the world”. ”

“We showed a survival benefit, which is the gold standard outcome of oncology clinical trials,  in a large randomized phase 3 trial.”

To Contact your Elected Officials

http://www.conservativeusa.org/mega-cong.htm

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From DeepCapture.com

Contact The General US Press

bwinges@thebeaconjournal.com; tucitydesk@timesunion.com; kwalz@abqjournal.com; news@mcall.com; citydesk@azstarnet.com; newstips@arizonarepublic.com; editors@app.com; newstips@ajc.com; news@statesman.com; businessnews@baltsun.com; tscarritt@bhamnews.com; localnews@globe.com; citydesk@bostonherald.com; citydesk@buffnews.com; localnews@charlotteobserver.com; news@dailyherald.com; mcooke@suntimes.com; ctc-editor@tribune.com; tcallinan@enquirer.com; sgoldberg@plaind.com; bmarrison@dispatch.com; ccnnewsrelease@bayareanewsgroup.com; metro@dallasnews.com; kcanfield@daytondailynews.com; newsroom@denverpost.com; metroiowa@dmreg.com; dfpcity@freepress.com; jon.wolman@detnews.com; perspectiva@elherald.com; frank.denton@jacksonville.com; newsroom@star-telegram.com; metro@fresnobee.com; mlloyd@grpress.com; citydesk@pnco.com; julien@courant.com; mplatte@honoluluadvertiser.com; citydesk@chron.com; newstips@indystar.com; levings@kcstar.com; news@knews.com; sertado@reviewjournal.com; hlnews@herald-leader.com; dnmetro@dailynews.com; national@latimes.com; bpost@courier-journal.com; metro@commercialappeal.com; nationalnews@miamiherald.com; gstanley@journalsentinel.com; dtice@startribune.com; newsroom@mobileregister.com; local@tennessean.com; citydesk@timespicayune.com; news@edit.nydailynews.com; enorton@nypost.com; nytnews@nytimes.com; metro@starledger.com; bstertz@dailypress.com; news@newsday.com; newsroom@northjersey.com; ekelley@oklahoman.com; local@ocregister.com; editor@orlandosentinel.com; pb_metro@pbpost.com; josephg@phillynews.com; nationaldesk@phillynews.com; letters@post-gazette.com; fcraig@tribweb.com; newsroom@news.oregonian.com; pjnews@projo.com; metroeds@newsobserver.com; news@timesdispatch.com; news@roanoke.com; editor@democratandchronicle.com; editor@rockymountainnews.com; metro@sacbee.com; pegmcentee@sltrib.com; rrivard@express-news.net; jeff.rose@uniontrib.com; metro@sfchronicle.com; nation@mercurynews.com; bswofford@pressdemocrat.com; citydesk@seattlepi.com; newstips@seattletimes.com; emaucker@sun-sentinel.com; news@spokesman.com; tpoor@post-dispatch.com; news@pioneerpress.com; national@sptimes.com; mconnor@syracuse.com; newstips@thenewstribune.com; trib_news@tampatrib.com; kfranck@theblade.com; news@tulsaworld.com; kpaulson@usatoday.com; katrice.franklin@pilotonline.com; nywireroom@dowjones.com; national@washpost.com; jweber@washingtontimes.com; metro@lohud.com; newstips@telegram.com; support@abcnews.go.com; info@ap.org; release@bloomberg.net; talkback@business2.com; evening@cbsnews.com; ctc-editor@tribune.com; csmnewsdesk@csps.com; public.information@cnn.com; drudge@drudgereport.com; pr@fastcompany.com; readers@forbes.com; letters@fortune.com; americasnewsroom@foxnews.com; ibdnews@investors.com; metrodesk@latimes.com; sfoxwell@npr.org; Today@NBCUNI.com; nytnews@nytimes.com; newsahead@msn.com; editors@newsweek.com; nathan@pacifica.org; letters@time.com; letters@usnews.com; pressreleases@upi.com; theforum@usatoday.com; nywireroom@dowjones.com; metro@washpost.com; jweber@washingtontimes.com

* * * * *

Contact the business the press

lpantages@thebeaconjournal.com; tubusiness@timesunion.com; mmurphy@abqjournal.com; mike.hirsch@mcall.com; business@azstarnet.com; kathy.tulumello@arizonarepublic.com; business@app.com; danason@ajc.com; kwarbelow@statesman.com; businessnews@baltsun.com; biznews@bhamnews.com; solomon@globe.com; business@bostonherald.com; gpotter@buffnews.com; obsbiz@charlotteobserver.com; jkane@dailyherald.com; dmiller@suntimes.com; DGreising@tribune.com; business@enquirer.com; podonnell@plaind.com; rcarter@dispatch.com; avoros@bayareanewsgroup.com; businessnews@dallasnews.com; mirby@daytondailynews.com; business@denverpost.com; lhicks@dmreg.com; business@freepress.com; biz@detnews.com; aportela@herald.com; paul.mattson@jacksonville.com; biz@star-telegram.com; business@fresnobee.com; ncrawley@grpress.com; tbarstow@patriot-news.com; dhaar@courant.com; dbutts@honoluluadvertiser.com; laura.goldberg@chron.com; steve.berta@indystar.com; clester@kcstar.com; business@knews.com; mhiesiger@reviewjournal.com; jbeach1@herald-leader.com; dnbiz@dailynews.com; bizletters@latimes.com; businessnews@courier-journal.com; joverstreet@commercialappeal.com; business@miamiherald.com; jsbiz@journalsentinel.com; ewieffering@startribune.com; kturner@mobileregister.com; dfisher@tennessean.com; money@timespicayune.com; swenger@edit.nydailynews.com; dgreenfield@nypost.com; bizday@nytimes.com; business@starledger.com; nsommers@dailypress.com; bizandtech@newsday.com; donnellon@northjersey.com; cbunyan@oklahoman.com; ghall@ocregister.com; businessnews@orlandosentinel.com; pbbusiness@pbpost.com; wwarren@phillynews.com; tgnoffo@phillynews.com; smassey@post-gazette.com; business@tribweb.com; business@news.oregonian.com; jkostrze@projo.com; mary.cornatzer@newsobserver.com; pfeibish@timesdispatch.com; rob.johnson@roanoke.com; erosen@DemocratandChronicle.com; reuteman@rockymountainnews.com; canderson@sacbee.com; mlimon@sltrib.com; blehman@express-news.net; financial@uniontrib.com; business@sfchronicle.com; business@mercurynews.com; tappel@pressdemocrat.com; margarettaus@seattlepi.com; business@seattletimes.com; alvasquez@sun-sentinel.com; scottm@spokesman.com; ekohn@post-dispatch.com; diverson@pioneerpress.com; biznews@sptimes.com; mmorelli@syracuse.com; marcelene.edwards@thenewstribune.com; mguidera@tampatrib.com; business@theblade.com; john.stancavage@tulsaworld.com; dcarroll@usatoday.com; bill.choyke@pilotonline.com; nywireroom@dowjones.com; beyersd@washpost.com; dhoneycutt@washingtontimes.com; mbieger@lohud.com; tgbiz@telegram.com

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You can still comment on our Petition 2007P-0297

CareToLive Citizens’ Petition with the FDA for them to Reconsider the Failure to Approve Provenge filed 7/27/07 (click this link to read)

FDA’s Reply to CareToLive’s Petition for the FDA To Reconsider the Provenge delay 1/17/08 (click this link) We are officially in FDA Petition Limbo
Summary: 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.

Here are a few of our comments although hundreds have been omitted from this site when they migrated the Citizen’s Petitions for the FDA over here. I am still waiting for them to post them. Paul Richards (consumer advocate (cough…cough) at FDA for CBER) is supposed to be handling that for me. Yo Paul, great advocacy job being an FDA puppet. You took every ill conceived idea to make Provenge appear faulty, like lies that it doesn’t show survival (even Maha admits it clearly shows survival)and chose to ignore the truth, and refuse to answer whether Provenge is safe, and refuse to act like a consumer advocate and make sure they investigate the Conflicts of interest and the bastardized question and maha’s and howie’s “leaked letter”. Shameful! You can call me anytime Paul and clear this up. I am still waiting.

http://www.regulations.gov/search/search_results.jsp?No=0&sid=11C0DFC568D5&Ne=2
+8+11+8053+8054+8098+8074+8066+8084+8055&Ntt=2007P-0297&Ntk=All&Ntx=mode
+matchall&N=0&css=0&rpp=50

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http://www.thoreau-fda.com/letter.php

Customize this letter and tell FDA Commissioner “Andy” (as he likes to be called) Von Eschenbach what you really think about the delay for over a year of the immunotherapy Provenge for the 30,000 American men who die of prostate cancer every year without any options (not to mention the rest of the men in the world)

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Sign the Provenge Petition

Read Petition: http://www.petitiononline.com/provenge/petition.html

Contact your Representatives and Senators and ask them to call for an investigation into the FDA’s handling of this travesty.

HOW TO FIND YOUR REPRESENTATIVE

Contact Your Elected Officials

by email http://www.conservativeusa.org/mega-cong.htm

by zipcode http://www.visi.com/juan/congress/index.html

If you go to the Congresspedia site http://www.Congresspedia.com and put your Representative’s name in the search box and scroll down and you will find all current contact information. Contact their Washington office as they have the most clout.

Call your Representative and ask for their Congressional Health Staffer.

Follow up with emails and faxes.

If you can visit their office.

Ask them to join the 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 Representative’s 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

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Contacting the White HouseContacting the White House [En Español]

E-Mail Please send your comments to comments@whitehouse.gov. Due to the large volume of e-mail received, the White House cannot respond to every message. For further up-to-date information on Presidential initiatives, current events, and topics of interest to you, please continue to use the White House website.

Note: Please submit messages in text format only. This inbox is unable to receive e-mails that contain graphics or attachments. After it arrives, you will receive an e-mail confirmation indicating successful delivery.

Vice President Richard Cheney: vice_president@whitehouse.gov guidelines for information about greetings.
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http://morningsentinel.mainetoday.com/view/columns/4742803.html

The Real FDA Scandel — Wall Street Journal
http://online.wsj.com/article/SB120225742208745785.html?mod=
opinion_main_review_and_outlooks

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.

5 reasons the E&C should conduct the investigation

Reason #1:

Abuse of Power by an FDA Special Employee with no FDA policy in place to censure or prevent such abuse of power
• Since the FDA Advisory Panel voted 13-4 in favor of approving Provenge, Dr. Scher, a dissenting voter, chose to take his private disagreement with the other members of the FDA Advisory Panel into the public realm by leaking a private letter meant for Commissioner VonEschenbach into the public non-peer reviewed political rag, the Cancer Letter.
• FDA Advisory Panel members have no FDA policy in place which prevents them from taking any pathway they chose to influence a pending FDA decision e.g. they can go on a public speaking tour, write editorials to the New York Times, speak on CNBC etc. They can abuse their position of power as an FDA Special Employee to influence a pending FDA decision without any punishment or any FDA oversight of their activity.
• An FDA employee who took such extraordinary measures to influence a pending FDA decision would clearly be fired, whereas a Special FDA Employee is subject to no oversight, no penalties, no punishment for this abuse of power.

Reason #2: Deeply rooted and very substantial undisclosed financial Conflicts of Interest rise to the level of a crime
• Dr. Scher has in the past been listed as an equity shareholder and is on the Scientific Board of Directors of a venture capital fund, Proquest, that was a majority stock holder of Novacea (8 million shares owned) which has a rival cancer therapy in the same stage of development as Provenge, targeting the same disease and stage. As a Board of Director, he has a fiduciary responsibility to protect the financial interest of this venture capital firm, including its main investment in Novacea.
• Dr. Scher is the lead investigator for Novacea’s pivotal Phase III study for Asentar. Such a trial would cost Novacea around $50 million, and this role should easily earn him $100-300,000
• 2 weeks after Provenge was rejected at the FDA, Novacea signed a $460 million deal with Schering Plough for Asentar. The stock went up $15, netting Proquest $120 million in profit in one day. If he still held it, Dr. Scher’s investment in Proquest certainly increased in value significantly.
• In a 10K release to investors ahead of this deal, Proquest indicated in its ‘forward looking statements’ that approval of Provenge would seriously impact the likely success of Asentar.

Reason #3: The extraordinary actions taken by Dr. Scher swayed the FDA’s decision against Provenge and were an abuse of power
• 13 of 17 Advisory Panel members voted to approve Provenge, the FDA assembled these experts to provide them with advice and nearly always follows such a large majority vote in favor of approval. What happened in this case?
• I believe you know all the circumstances around the leaked letters to the Cancer Letter. These letters and lobbying within the FDA swayed the decision.

Reason #4: Internal FDA lack of clear management responsibilities lead to turf battles over the Provenge application and abuse of power by Richard Padzur of the FDA
• The Center for Biologic Evaluation and Research (CBER) was given the responsibility, for the first time ever, to review an oncology drug application
• The Center for Drug Evaluation and Research (CDER) Oncology Drug Division, headed by Richard Padzur, has overseen all past oncology drug applications.
• Richard Padzur apparently took extraordinary measures by lobbying within the FDA to reject Provenge and possibly also collaborated with Dr. Scher in the writing and leaking of the critical letter to the Cancer Letter.
• This constitutes a serious abuse of power which needs to be revealed to the public so that Richard Padzur cannot continue to use abusive power to maintain his monopoly over oncology drug approvals.

Reason #5: Inside information was leaked to financial firms resulting in upwards of $500 million in profits earned after the FDA rejected Provenge
• Hedge funds and other large investors held 20 million shares short in Dendreon leading up to the Panel vote in March 2007. After the vote, it appeared that FDA approval was imminent and the stock tripled in value.
• However, instead of the 20 million short investors closing out their position before the stock went even higher after an imminent FDA approval, they chose to increase their short investment to 40 million shares (as of May 1st 2007) just after Dr. Scher leaked his letters to the Cancer Letter. This meant that an additional $400 million was invested in a short position against Dendreon after Dr. Scher leaked his letter, hoping the FDA would reject Provenge.
• Why would hedge funds put $400 million at risk when all other investment professionals such as CNBC, Forbes etc. were writing about an imminent FDA approval? Because inside information from the FDA or from Dr. Scher was being leaked to them.
• It should be noted that one of Proquest’s main stock holder’s is Michael Milken, who knew Dr. Scher personally as Dr. Scher was on the Scientific Board of Directors for Mr. Milken’s prostate cancer foundation.
• When the FDA rejected Provenge the stock dropped $12, netting a $500 million profit for the hedge funds.
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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.

Tell them you are very disappointed in the decision by Rep John Dingell and Rep Frank Pallone not to hold 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.

Raise A Flag For Prostate Cancer
Contact your state Governor - See if your State signed a proclamation to make September Prostate Cancer Awareness Month (below). Ask your current Governor to support the Provenge hearings and to contatct your State Representative and ask them to sign the letter calling for hearings.
http://www.usa.gov/Contact/Governors.shtml

Click on your State flag and hit Control + p key and it will print the page with your Governors seal (past or present) supporting Prostate Cancer month, or go up too file, save as, and save it to your desktop. Send it to your Governor along with the Representatives letter asking for hearings along with other useful information to educate them about the Provenge travesty. http://pcaawareness.net/pcam_display.html

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.shtm
Thanks For Your Help!

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