We are hot on the trail of the miscreants that derailed Provenge, a safe and effective immunotherapy for prostate cancer, condemning 30,000 American men to death without hope, in order to reap windfall profits.

Ed Silverman of Pharmalot reports on the shenanigans. (click link)

They may have taken down the links but we have the Proquest Investments 2007 Scientific Advisory Committee on our CareToLive research page showing the connections to Howard Scher and Milken’s Prostate Cancer Foundation that claims they want faster cures, yet remained mum on the Provenge Debacle. 3 Congressment are now calling for a Congressional hearing.

See our prior blog on Michael Milken’s Prostate Cancer Foundation and The Proquest Investment Fund / Howard Scher /FDA Unholy Alliance.(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!

December 13, 2007

The Honorable John Dingell
Chairman
Committee on Energy and Commerce
2125 Rayburn HOB
Washington DC

The Honorable Frank Pallone
Chairman
Subcommittee on Health
Committee on Energy and Commerce
2125 Rayburn HOB
Washington DC

The Honorable Joe Barton
Ranking Member
Committee on Energy and Commerce
2322-A Rayburn HOB
Washington DC

The Honorable Nathan Deal
Ranking Member
Subcommittee on Health
The Honorable Joe Barton
Ranking Member
Committee on Energy and Commerce
2322-A Rayburn HOB
Washington DC

Dear Chairman Dingell and Ranking Member Barton and Subcommittee Chairman Pallone and Ranking Member Deal,

We are writing to express our serious concerns about the failure of the Food and Drug Administration (FDA) to approve the licensure of Provenge, (sipuleucel-T), a potentially life-saving therapy for those suffering from advanced prostate cancer. We write to request the Committee on Energy and Commerce conduct a hearing to examine the conflict of interests governing the FDA in this decision.

While much has been written on both sides of the issue about the effectiveness of the therapy known as Provenge, there is reason to believe that serious ethics rules were violated by two FDA advisory panel members in their decision and that these violations played a role in the subsequent FDA decision to not approve Provenge at this time.

In March, the FDA’s expert advisory panel (comprised of leading immunotherapy experts, oncologists, and statisticians) voted unanimously that Provenge is safe and voted 13-4 that it was effective, meeting the statutory burden of proof provided for in FDAMA for immediate licensure of Provenge while the sponsor of this therapy continued and completed its ongoing study. Overruling this panel of scientific experts, the FDA demanded additional data from clinical trials which won’t be completed until 2010.

Prostate cancer activists have raised questions about two of the negative voters, academic medical oncologists, Maha Hussain and Howard Scher. Dr. Howard Scher is lead investigator for a competing cancer drug made by Novacea and is listed as an adviser to a large venture capital firm that is also a major investor in Novacea. We believe the FDA should not be appointing scientists leading the testing of a rival drug for another firm onto an advisory committee evaluating Provenge nor should the FDA appoint an adviser to a large investor in such a competitive firm as a panel member. It is important that Congress examines possible ethical violations of these panel Members considering the viability of potentially important life-saving drugs.

A lawsuit was recently filed by Dublin, Ohio based nonprofit CareToLive in federal court in Columbus. The lawsuit accuses FDA of ignoring conflict-of interest issues with some medical advisers chosen to review the therapy.

Over the last few years, FDA has repeatedly failed to take substantive action to effectively restore confidence in the agency. According to its January 2007 report to Congress, the FDA granted waivers to 24 percent of the 928 members of its 47 advisory committees that met during the 14 month period from November 10, 2005 through January 4, 2007.

We believe that the FDA can and should eliminate these conflicts of interest so that everyone involved — patients, doctors, companies, scientists, investors and the public — believes the process has been fair and evenhanded, and the end result dictated by the science. Top -notch scientists without such substantial conflicts are available to the FDA now and are willing to serve, as noted in a recent letter to Senators Kennedy and Dodd by a number of prominent physicians, including two former editors of the New England Journal of Medicine.

The Food and Drug Administration Modernization Act of 1997 intended to make the regulatory process less arbitrary and more transparent. We must strengthen and streamline the process to ensure prompt and efficient approval of therapies such as Provenge that could potentially benefit millions of Americans with cancer.

We request your committee conduct a hearing to discuss the FDA’s role in this recent decision and the conflicts of interests in the agency. Thank you for your consideration of our request.

Sincerely,

Michael H. Michaud
Member of Congress

Dan Burton
Member of Congress

Tim Ryan
Member of Congress

Congressmen Mike Michaud of Maine, Dan Burton of Indiana, and Tim Ryan of 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.

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

Here are the members of the Congressional subcommittee that would take up the investigation and institute a hearing. Please let them know that you want to get to the bottom of what went terribly wrong with the Provenge approval process. What about the conflicted naysayers and the “leakers”? What about the 18,000 men who have died since approval was delayed?

You may also use this link to contact Frank Pallone, Chairman of the Subcommittee on Health also in charge of implementing hearings on the Provenge debacle.

You may also fax them at 202-225-2525. Thanks.

Please also contact your local Congressional representatives and fax them the congressional letter and ask them to join us. An Easy Way To Contact Your Elected Officials - (click here) EVERY VOICE COUNTS!
_______________

Petition for the FDA to Reconsider the Failure to Approve Provenge (link)

Please 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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Tags: Asentar, Brachytherapy, Care To Live, CareToLive, Dendreon, Ed Silverman, FDA, howard i scher, Immunotherapy, Jay Moorin, Michael Milken, novacea, PCF, Pharmalot, Proquest Investments, Prostate Cancer, Prostate Cancer Foundation, provenge, sloan kettering

This entry was posted on Wednesday, January 2nd, 2008 at 7:39 am and is filed under The Dysfunctional FDA, The Lawsuit. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.