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.

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

Petition for the FDA to Reconsider the Failure to Approve Provenge
Tell the FDA what you really think about the delay of Provenge
READ OUR PETITION HERE
Petition for the FDA to Reconsider the Failure to Approve Provenge (click this link)

Tell the FDA what you really think about the delay of Provenge

Submit any comments 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.
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Tags: Care To Live, CareToLive, Dan Burton, Dendreon, FDA, Kerry Donahue, Mike Michaud, nature biotechnology, provenge, Tim Ryan

This entry was posted on Sunday, January 20th, 2008 at 4:57 am and is filed under The Cause, The Dysfunctional FDA. 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.