psycho-pharma schreef:
Ik het kader van mijn cursus empowerment (nee dus, aan die flauwe kul doe ik niet mee), heb ik een mail gestuurd naar de FDA over het gedrag (de brief) van dr. Scher en een publicatie uit 2004.
Vanmiddag reeds een reaktie over doorsturen van mijn stuk.
Good morning Mr. Psycho
Thank you for your inquiry to FDA's Center for Biologics Evaluation and Research (CBER) regarding Provenge, the product that recently was discussed at a advisory committee meeting. CBER, one of six centers within FDA, is responsible for the regulation of biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products.
I will forward the links provided to the Office of Cellular, Tissue and Gene Therapies.
Again, thank you.
Best regards,
Lanessa Hill
Public Affairs Specialist
Consumer Affairs Branch
Division of Communication and Consumer Affairs
Center for Biologics Evaluation and Research
This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
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De gestuurde stukken:
From: mr. Psycho
Sent: Friday, April 13, 2007 4:41 PM
To: CBER OCTMA Consumer Account
Subject: About Sipuleucel-T Dendreon
Good day,
I am mr. Psycho from The Netherlands.
I have a request about the consequences in the attitude of the FDA considering the 17-0 and 13-4 decision of the Cellular, Tissue and Gene Therapies Advisory Committee March 29 & 30, 2007 Meeting about Docket No. 2007N-0061 "Sipuleucel-T Dendreon”.
Please read the following 2 articles, both remarkable articles
I hope it will help to guide your discussion and decision, so you will help people with prostate cancer to live longer.
1st (is this legally permitted?)
RealMoney - Premium Content
Oncologist to FDA: Don't approve Provenge
4/13/2007 2:34 PM EDT
By Adam Feuerstein
The Cancer Letter is reporting in this week's issue that Howard Scher, an oncologist... More
Adam Feuerstein
Oncologist to FDA: Don't approve Provenge
4/13/2007 2:34 PM EDT
The Cancer Letter is reporting in this week's issue that Howard Scher, an oncologist who sat on the FDA advisory panel which reviewed Dendreon's Provenge, has written a letter to the FDA imploring the agency to not approve Provenge.
Scher was one of the panel members who voted against Provenge on March 29.
As quoted in the Cancer Letter, Scher writes to the FDA, "My vote was based on the fact that neither of the two trials presented met their endpoint, which renders the significance of results from any subsequent analyses as 'exploratory' and 'hypothesis generating'."
2nd
www.lef.org/magazine/mag2005/jun2005_...2005
FDA Delays Promising Prostate Cancer Vaccine
Scanning electron micrograph of prostatic cancer cell, magnified 6,000 times.
In 2004, Life Extension reported on a Phase III study showing that men with metastatic prostate cancer who received an immune-boosting vaccine called Provenge™ were eight times more likely to live six months without disease progression than those who did not receive the vaccine.1 This anti-cancer vaccine, however, was effective only in men with a Gleason score of 7 or less. (Higher Gleason scores are indicative of a more aggressive type of prostate cancer.)
The FDA refused to accept the study results because the agency does not allow retrospective analysis of a subgroup that may have benefited from an experimental drug. To gain FDA approval, Dendreon, the company testing the vaccine, was forced to begin a new study on men with Gleason scores of 7 or less. However, Dendreon continued to follow patients in the original study, and the results continue to be impressive. Of the 75 patients who entered the trial with a Gleason score of 7 or less, those receiving Provenge™ were 3.7 times more likely to be alive after 30 months; this translates into 53% of the Provenge™ group staying alive compared to only 14% of the placebo group. The Provenge™ group also remained pain-free twice as long on average as the placebo group.
A Wall Street Journal editorial commented on the FDA’s deplorable delay by stating:
“We know that it works, and we know why it works. In any rational regulatory environment, that would be reason to speed Provenge™ to market. But this is the FDA we are talking about.”2
Fast forward to 2005, and the results of a new clinical study on Provenge™ show that three times as many advanced prostate cancer patients who received Provenge™ were alive compared to patients receiving a placebo.3 This study evaluated 127 patients with prostate cancer that did not respond to androgen-deprivation therapy (that is, hormone-refractory prostate cancer). Cancer experts consider this patient subset to have a dismal prognosis, with most dying of the disease within a few years. In the Provenge™ study, 34% of the patients receiving Provenge™ were still alive after three years compared to only 11% of men who were randomly assigned a placebo.3
Under FDA regulations, pros-tate cancer patients with such a dire prognosis had to risk receiving no therapy (the placebo) in the hope that they might be lucky enough to be in the study arm that received the promising drug (Provenge™). Life Extension has advocated that cancer patients with advanced disease should not have to risk receiving a worthless placebo. Historical controls could be used instead of placebos to spare such patients almost certain death.
Prostate cancer kills more than 30,000 American men every year.3 Provenge™ has clearly demonstrated that it improves survival rates, yet the FDA still has not approved it. Considering that the FDA could have approved Provenge™ as early as 2002, the agency’s delay in approving this one drug alone may have resulted in the premature death of tens of thousands of men.
—William Faloon
Thank you for your time,
Sincerely,
mr. Psycho