mikey2much
Literotica Guru
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- Nov 28, 2006
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My brother's wife is battling cancer, so he follows carefully any developments in the research field. He forwarded this letter to me. Maybe you might send it on to somebody you know that might be able to help.
mikey
Subject: Re: [MM] MYELOMA Digest - 25 May 2007 to 26 May 2007 – Special issue (#2007-170)
Date: May 26, 2007 > Producers/staff of NPR
Roughly 27,000 men die in the U.S. each year from Androgen Independent Prostate Cancer (AIPC), this is the latest stage of the disease, where pretty much every other therapy has failed to halt the progression of the cancer. The average life expectancy of those who reach this stage is approximately 19 months.
Recently the FDA denied approval to a revolutionary treatment for this condition, issuing instead a "CR" letter in which they demanded more evidence of efficacy. The treatment is called "Provenge"...is not a "chemo" agent, but is termed an "Active Cellular Immunotherapeutic" Cancer Vaccine, or just an 'Active Immunotherapy'. Unlike chemo agents, which are basically poisons, which attempt to kill cancer cells before they kill regular cells, Active Immunotherapeutics attempt to 'fine tune' or 'boost' the body's natural immune system enabling it to more readily recognize cancer and thus mount the appropriate defense. Provenge is like sending one's immune system to 'grad school' so to speak. It takes a couple of months to become effective in one's system but then continues working for years...and it doesn't make a person deathly ill as chemo does.
On 3/29 an FDA convened "Advisory Panel" voted unanimously (17 to 0) that Provenge was safe, and voted 13 to 4 that Provenge demonstrated "substantial evidence" of efficacy. Interestingly, 3 of the 4 panelists who voted negative regarding 'efficacy' had signed Conflict of Interest statements.... and were apparently appointed by Dr. Pazdur's CDER division. CDER is the "oncology" division within the FDA.
The CBER division under Dr. Goodman is the "biologics" section, which had been granted the responsibility to review Provenge and eventually decide on whether to approve or reject Provenge.
Approximately 97.5% of the time the FDA follows the recommendation of its Advisory Panel (also called an Advisory Committee) especially when there are no safety issues (note the 17 to 0 safety vote), and the drug or treatment is for a terminal condition with no acceptable alternative treatments available (this is the case with AIPC). The only currently FDA approved treatment is a chemo agent called Taxotere which only extends life approximately 10 weeks, but its side effects are so severe that the majority of AIPC patients simply refuse to take it. Taxotere's side effects are extremely severe...one side effect is death!!
Earlier this month (5-09-07) the FDA, despite the recommendation of its own > Advisory Panel, denied approval of Provenge. The "CR" letter issued to Dendreon (Provenge is produced by Dendreon Corporation of Seattle, Washington) will result in a delay estimated at up to 3 years!! Dendreon also has a vaccine for breast cancer called "Neuvenge"...its development has been sidelined for 2 years due to financial constraints which have resulted from a massive and relentless "short" campaign waged against the company by powerful Wall Street entities. Provenge achieved a 300% increase in overall survival (OS) measured at 3 years. That is phenomenal in the treatment of cancer...A 3-FOLD INCREASE in OVERALL SURVIVAL!!! Provenge achieved these amazing survival results with only transient flu-like symptoms being the side effect...FEVER and CHILLS lasting a couple of days!!!
These men who are still alive going on 7 years later, achieved this without the benefit of "booster" infusions of Provenge as well...one booster infusion given approximately 2 years after the initial 3 infusion treatment has been recently demonstrated to achieve a "doubling" of measured immune response. Multiple recipients pf Provenge from the Phase 3 trials are still alive 6 years later...going on 7 years!! Their survival isn't even fully reflected in the statistics because the trial only ran for 3 years.
Provenge represents a multi-billion dollar threat to the entrenched and highly lucrative "chemo" dynasties of the huge Pharmaceutical Giants. Follow the Money!!! 27,000 men will die needlessly early every year which Provenge is held off the market; that could be 75,000 to 80,000 men in three years.
Ladies and Gentlemen, this decision was simply about money and politics at the highest level of the FDA. Former FDA Deputy Director Dr. Scott Gottlieb (now with the American Enterprise Institute) is on record years ago saying that Provenge should have been approved. He recently, in an interview with Paul Gigot of the Wall Street Journal, reiterated that Provenge "should have been approved”. by the FDA.
Please contact me regarding further information....or I have included a couple of links to well known 'not-for-profit' patient advocacy groups. Feel free to contact Frank Burroughs of "Abigail Alliance, and Jim Kiefert of "Us TOO"...they will verify what I have expressed here. I also have included a link to a piece, which recently appeared in the Wall Street Journal entitled "Black Wednesday at the FDA" by a Dr. Mark Thornton. Also, a link to a group consisting of a number of patient advocacy groups and activists attempting to force the FDA to rescind their decision and make Provenge available immediately.
Abigail Alliance...Frank Burroughs> _http://abigail-alliance.org/_ (http://abigail-alliance.org/)
> Us Too....Jim Kiefert > _http://www.ustoo.com/_ (http://www.ustoo.com/)
"Black Wednesday at the FDA" > _http://www.cancercompass.com/message-board/message/all, 12187,0.htm_
> (http://www.cancercompass.com/message-board/message/all,12187,0.htm)
> Provenge Now> _http://www.provengenow.org/_ (http://www.provengenow.org/)
Please consider turning your vast power and influence towards investigating this travesty, which the FDA has wrought on those suffering with terminal prostate cancer. We desperately need the facts of this story to be widely publicized...only with massive public awareness and outrage can the FDA be compelled to give account of their decision regarding Provenge, and hopefully forced to rescind it. 27,000 men each year, men without any powerful lobbyists to speak for them, will die needlessly without Provenge. Please speak for them, become their advocate. The life you save may be your own, the life of a dearly loved family member, or an esteemed co-worker.
THE REALITY IS THAT BIG PHARMA (BP) CONTOLS THE FDA AND ANYTHING THAT MAY> HARM EXISTING CHEMOS (revenues) IS UNLIKELY TO RECEIVE A FAVORABLE REVIEW, UNLESS WE ALL PUT PRESSURE ON THE FDA, AS BIG P DOES!
International Myeloma Foundation => http://www.myeloma.org ]
mikey
Subject: Re: [MM] MYELOMA Digest - 25 May 2007 to 26 May 2007 – Special issue (#2007-170)
Date: May 26, 2007 > Producers/staff of NPR
Roughly 27,000 men die in the U.S. each year from Androgen Independent Prostate Cancer (AIPC), this is the latest stage of the disease, where pretty much every other therapy has failed to halt the progression of the cancer. The average life expectancy of those who reach this stage is approximately 19 months.
Recently the FDA denied approval to a revolutionary treatment for this condition, issuing instead a "CR" letter in which they demanded more evidence of efficacy. The treatment is called "Provenge"...is not a "chemo" agent, but is termed an "Active Cellular Immunotherapeutic" Cancer Vaccine, or just an 'Active Immunotherapy'. Unlike chemo agents, which are basically poisons, which attempt to kill cancer cells before they kill regular cells, Active Immunotherapeutics attempt to 'fine tune' or 'boost' the body's natural immune system enabling it to more readily recognize cancer and thus mount the appropriate defense. Provenge is like sending one's immune system to 'grad school' so to speak. It takes a couple of months to become effective in one's system but then continues working for years...and it doesn't make a person deathly ill as chemo does.
On 3/29 an FDA convened "Advisory Panel" voted unanimously (17 to 0) that Provenge was safe, and voted 13 to 4 that Provenge demonstrated "substantial evidence" of efficacy. Interestingly, 3 of the 4 panelists who voted negative regarding 'efficacy' had signed Conflict of Interest statements.... and were apparently appointed by Dr. Pazdur's CDER division. CDER is the "oncology" division within the FDA.
The CBER division under Dr. Goodman is the "biologics" section, which had been granted the responsibility to review Provenge and eventually decide on whether to approve or reject Provenge.
Approximately 97.5% of the time the FDA follows the recommendation of its Advisory Panel (also called an Advisory Committee) especially when there are no safety issues (note the 17 to 0 safety vote), and the drug or treatment is for a terminal condition with no acceptable alternative treatments available (this is the case with AIPC). The only currently FDA approved treatment is a chemo agent called Taxotere which only extends life approximately 10 weeks, but its side effects are so severe that the majority of AIPC patients simply refuse to take it. Taxotere's side effects are extremely severe...one side effect is death!!
Earlier this month (5-09-07) the FDA, despite the recommendation of its own > Advisory Panel, denied approval of Provenge. The "CR" letter issued to Dendreon (Provenge is produced by Dendreon Corporation of Seattle, Washington) will result in a delay estimated at up to 3 years!! Dendreon also has a vaccine for breast cancer called "Neuvenge"...its development has been sidelined for 2 years due to financial constraints which have resulted from a massive and relentless "short" campaign waged against the company by powerful Wall Street entities. Provenge achieved a 300% increase in overall survival (OS) measured at 3 years. That is phenomenal in the treatment of cancer...A 3-FOLD INCREASE in OVERALL SURVIVAL!!! Provenge achieved these amazing survival results with only transient flu-like symptoms being the side effect...FEVER and CHILLS lasting a couple of days!!!
These men who are still alive going on 7 years later, achieved this without the benefit of "booster" infusions of Provenge as well...one booster infusion given approximately 2 years after the initial 3 infusion treatment has been recently demonstrated to achieve a "doubling" of measured immune response. Multiple recipients pf Provenge from the Phase 3 trials are still alive 6 years later...going on 7 years!! Their survival isn't even fully reflected in the statistics because the trial only ran for 3 years.
Provenge represents a multi-billion dollar threat to the entrenched and highly lucrative "chemo" dynasties of the huge Pharmaceutical Giants. Follow the Money!!! 27,000 men will die needlessly early every year which Provenge is held off the market; that could be 75,000 to 80,000 men in three years.
Ladies and Gentlemen, this decision was simply about money and politics at the highest level of the FDA. Former FDA Deputy Director Dr. Scott Gottlieb (now with the American Enterprise Institute) is on record years ago saying that Provenge should have been approved. He recently, in an interview with Paul Gigot of the Wall Street Journal, reiterated that Provenge "should have been approved”. by the FDA.
Please contact me regarding further information....or I have included a couple of links to well known 'not-for-profit' patient advocacy groups. Feel free to contact Frank Burroughs of "Abigail Alliance, and Jim Kiefert of "Us TOO"...they will verify what I have expressed here. I also have included a link to a piece, which recently appeared in the Wall Street Journal entitled "Black Wednesday at the FDA" by a Dr. Mark Thornton. Also, a link to a group consisting of a number of patient advocacy groups and activists attempting to force the FDA to rescind their decision and make Provenge available immediately.
Abigail Alliance...Frank Burroughs> _http://abigail-alliance.org/_ (http://abigail-alliance.org/)
> Us Too....Jim Kiefert > _http://www.ustoo.com/_ (http://www.ustoo.com/)
"Black Wednesday at the FDA" > _http://www.cancercompass.com/message-board/message/all, 12187,0.htm_
> (http://www.cancercompass.com/message-board/message/all,12187,0.htm)
> Provenge Now> _http://www.provengenow.org/_ (http://www.provengenow.org/)
Please consider turning your vast power and influence towards investigating this travesty, which the FDA has wrought on those suffering with terminal prostate cancer. We desperately need the facts of this story to be widely publicized...only with massive public awareness and outrage can the FDA be compelled to give account of their decision regarding Provenge, and hopefully forced to rescind it. 27,000 men each year, men without any powerful lobbyists to speak for them, will die needlessly without Provenge. Please speak for them, become their advocate. The life you save may be your own, the life of a dearly loved family member, or an esteemed co-worker.
THE REALITY IS THAT BIG PHARMA (BP) CONTOLS THE FDA AND ANYTHING THAT MAY> HARM EXISTING CHEMOS (revenues) IS UNLIKELY TO RECEIVE A FAVORABLE REVIEW, UNLESS WE ALL PUT PRESSURE ON THE FDA, AS BIG P DOES!
International Myeloma Foundation => http://www.myeloma.org ]
