omkring en af de læger der i 2007 skrev til FDA efter panel meeting (hvor han deltog og stemte nej)
Nu forsøger man at afdække, og stille ham og Scher (den anden der skrev til FDA som også deltog i mødet og stemte nej) til regnskab
samt at få Obama og senat + kongres til at undersøge alle de manipulationer der er sket gennem FDA
hvor præparater ikke er blevet godkendt - udelukkende pga lobbyrisme fra de store "konkurerende medicin virksomheder" samt deres kæmpe modstand mod f eks immunterapi som ny behandlings metode fremfor kemo.
http://www.investorvillage.com/mbthread.asp?mb=971&pm=277081&nm=277120&sync=1&tid=7270083&showall=1
Det har f eks taget 2 år at få disse svar frem:
The 11 Declarations by Richard Pazdur
Here are the 11 Declarations made today by Richard Pazdur. Please read them, think about them and give some feedback on them. I give my initial reaction at the end of the list.
DECLARATION OF DR. RICHARD PAZDUR
1. I am a Supervisory Medical Officer in the Office of Oncology, Center for Drug Evaluation and Research (“CDER”), United States Food and Drug Administration (“FDA”), located in Silver Spring, Maryland. My duties include supervision of the Office of Oncology Drug Products, leading the FDA-wide oncology program, and coordinating oncology-related activities and the discussion of reviews of oncology products conducted in other Centers. The purpose of this program is to provide consistent and uniformity I the regulation of oncology-related products throughout the FDA.
2. The statements made in this declaration are based upon my personal knowledge and information about which I have become knowledgeable through my review of official agency records within CDER’s control.
3. I submit this declaration in support of the government’s Motion for Summary Judgement in the above-captioned case. The purpose of this declaration is to explain why I cold not produce any documents in response to the FOIA request that is the subject of the Complaint in this case.
4. Plaintiff’s request asks for, in part, “a copy of all letters written to the FDA (or prepared by the FDA) and purported to be from Dr. Scher, Dr. Hussain and Doctor Fleming in between March 29th 2007 and April 30th 2007, regarding the BLA submitted for Provenge also known as Sipuleucel-T including the envelope or other means of communication whereby the FDA received such letters and a copy of any record.” See Attachment 1.
5. I am an addressee of Dr. Maha Hussain’s April 27, 2007 letter to numerous FDA employees. See Attachment 2. I am also listed as a “cc” recipient on the April 5, 2007 letters from Dr. Howard Scher to Dr. Janet Woodcock, Director of CDER. To Dr. Celia Witten, Director of the Center for Biologics Evaluation and Research (“CBER”), and Andrew von Eschenbach, Commissioner of FDA. See Attachments 3, 4, and 5.
6. At the request of CDER’s Division of Information Disclosure Policy (“DIDP”), I searched both my paper and computer files, and I was unable to locate any documents that were responsive to Plaintiff’s request.
7. I recall receiving both hard copies and electronic copies of these letters in April 2007. However, as these letters related to a specific regulatory application conducted by a different FDA Center (CBER), did not fall under my direct regulatory supervision, and did not require a response from me, I shredded my hard copies of these letters and deleted any electronic copies. The documents were shredded and deleted within a month of receipt.
8. I do not keep personal copies of any regulatory communications. Official copies of regulatory correspondence are kept in the official regulatory document room of the specific center assigned to an application.
9. I did not disclose Dr. Scher’s or Dr. Hussain’s letters to “a individuals outside of the FDA, or any media outlet, including a publication called ‘The Cancer Letter.’” See Attachment 1.
10.I did not write any portion of the letters that Drs. Scher, Hussain, or Fleming sent to the FDA.
11.I never received a copy of a letter from Dr. Thomas Fleming to the FDA regarding Provenge.
Pursuant to 28 U.S.C. § 1746, I declare under penalty of perjury that the foregoing is true and correct.
Executed on 15 day of May, 2009.
Dr. Richard Pazdur
Supervisory Medical Officer
Office of Oncology, CDER
And now for my initial comments after going through them the first time:
#1
"My duties include supervision of the Office of Oncology Drug Products, leading the FDA-wide oncology program, and coordinating oncology-related activities and the discussion of reviews of oncology products conducted in other Centers. The purpose of this program is to provide consistent and uniformity I the regulation of oncology-related products throughout the FDA."
How can he lead, coordinate and discuss and then later say it did not fall under his direct regulatory supervision and "did not require a response from him." Discuss and response are quite close, are they not? Are we to believe he did not discuss this or respond to the letters? FDA said they sided with the minority doctors, are not these doctors from Pazdur’s side of the FDA fence?
As for the consistent and uniformity, he publicly stated he approved Avastin even though it did not show survival because he said he felt sympathy for the patients. He said there was regulatory flexibility. He can say what he wants but he helped stop the approval of Provenge when it did show survival and he did not feel sorry for the 96,000 men who were inflicted with AIPC. No consistency whatsoever.
# 2
"The statements made in this declaration are based upon my personal knowledge and information about which I have become knowledgeable through my review of official agency records within CDER’s control."
That is a lie. He became knowledgeable when Scher and Hussain's letters and e-mails came his way.
# 5
He uses the Cancer Letter's published date of Maha's letter, April 27th.
He says he is listed as a “cc” recipient on the April 5, 2007 letters from Howard Scher. It is plural, letters, how many letters did he receive from Howie?
# 7
He says these letters related to a specific regulatory application conducted by a different FDA center, CBER, and did not fall under his direct regulatory supervision.
Oh, so now he is concerned about regulations. And, his first declaration says his duties include FDA-wide oncology program and discussing reviews of oncology products conducted in other Centers.
So why were Hussain and Scher, who are from his Center, even on the panel if this was just for CBER?
Why did he pass notes to Hussain?
Who tampered with the question?
Didn't he threaten a protest if Provenge got approved? Was it FDA-wide?
# 8
"I do not keep personal copies of any regulatory communications." This is scary to hear from a government worker. Why wouldn’t he keep these, especially for a case that the DOJ says is not ripe? If you have such an important position and are worried about specific regulatory applications, why not?
Oh, I see, the official copies or regulatory correspondence are kept in “the official regulatory document room.” Well, can we look in there for documents you may have missed? Are copies of all the ones you shredded and deleted in that room? What about the envelopes? Are they in that room?
# 9
He did not disclose Howie’s and Maha’s letters to "individuals outside the FDA". What about individuals inside the FDA? Maybe you gave them to someone inside and that person got them to the Cancer Letter and others outside the FDA?
My Overall Humble Opinion
This is all just a bunch of horse manure and lies. A complete waste of our tax dollars. And he is the cancer czar? He had something to say here. What a lying piece of garbage. If he knew he shredded the documents and deleted the e-mails “within a month of receipt,” on May 23 2007, why did he spend our tax dollars on DOJ representation, court costs and FOIA compliance people looking for something he already destroyed? He needs to go down!
Men læs selv - WSJ er begyndt at grave - og Kerry m fl graver med - jeg er meget spændt på hvad der kommer ud af det.
HER er en artikkel fra WSJ fra maj 2007 hvor man kan se en tilsvarende historie som DNDN's provenge - bare med et andet firma og præparat
http://online.wsj.com/article/SB117824324837591782.html?mod=opinion_main_commentaries
så Dndn var ikke ene om at blive skubbet uretmæssigt ud på sidelinjen på den måde.
------------
Ellers omkring aktien i nuet - så tror jeg der sker en konsolideringsfase nu kursmæssigt, hvor firmaet har en række møder hvor deres resultater og planer formidles, mens de ansætter folk til produktion - er nu 87 ledige stillinger - og "de store" langsomt bygger long positioner op, og der forhandles med en ROW partner.
Jeg holder fortsat mine aktier long - og er forberedt på at der godt kan blive stille i en periode, selvom der jo fortsat er en del triggere
Vh
Hya
Nu forsøger man at afdække, og stille ham og Scher (den anden der skrev til FDA som også deltog i mødet og stemte nej) til regnskab
samt at få Obama og senat + kongres til at undersøge alle de manipulationer der er sket gennem FDA
hvor præparater ikke er blevet godkendt - udelukkende pga lobbyrisme fra de store "konkurerende medicin virksomheder" samt deres kæmpe modstand mod f eks immunterapi som ny behandlings metode fremfor kemo.
http://www.investorvillage.com/mbthread.asp?mb=971&pm=277081&nm=277120&sync=1&tid=7270083&showall=1
Det har f eks taget 2 år at få disse svar frem:
The 11 Declarations by Richard Pazdur
Here are the 11 Declarations made today by Richard Pazdur. Please read them, think about them and give some feedback on them. I give my initial reaction at the end of the list.
DECLARATION OF DR. RICHARD PAZDUR
1. I am a Supervisory Medical Officer in the Office of Oncology, Center for Drug Evaluation and Research (“CDER”), United States Food and Drug Administration (“FDA”), located in Silver Spring, Maryland. My duties include supervision of the Office of Oncology Drug Products, leading the FDA-wide oncology program, and coordinating oncology-related activities and the discussion of reviews of oncology products conducted in other Centers. The purpose of this program is to provide consistent and uniformity I the regulation of oncology-related products throughout the FDA.
2. The statements made in this declaration are based upon my personal knowledge and information about which I have become knowledgeable through my review of official agency records within CDER’s control.
3. I submit this declaration in support of the government’s Motion for Summary Judgement in the above-captioned case. The purpose of this declaration is to explain why I cold not produce any documents in response to the FOIA request that is the subject of the Complaint in this case.
4. Plaintiff’s request asks for, in part, “a copy of all letters written to the FDA (or prepared by the FDA) and purported to be from Dr. Scher, Dr. Hussain and Doctor Fleming in between March 29th 2007 and April 30th 2007, regarding the BLA submitted for Provenge also known as Sipuleucel-T including the envelope or other means of communication whereby the FDA received such letters and a copy of any record.” See Attachment 1.
5. I am an addressee of Dr. Maha Hussain’s April 27, 2007 letter to numerous FDA employees. See Attachment 2. I am also listed as a “cc” recipient on the April 5, 2007 letters from Dr. Howard Scher to Dr. Janet Woodcock, Director of CDER. To Dr. Celia Witten, Director of the Center for Biologics Evaluation and Research (“CBER”), and Andrew von Eschenbach, Commissioner of FDA. See Attachments 3, 4, and 5.
6. At the request of CDER’s Division of Information Disclosure Policy (“DIDP”), I searched both my paper and computer files, and I was unable to locate any documents that were responsive to Plaintiff’s request.
7. I recall receiving both hard copies and electronic copies of these letters in April 2007. However, as these letters related to a specific regulatory application conducted by a different FDA Center (CBER), did not fall under my direct regulatory supervision, and did not require a response from me, I shredded my hard copies of these letters and deleted any electronic copies. The documents were shredded and deleted within a month of receipt.
8. I do not keep personal copies of any regulatory communications. Official copies of regulatory correspondence are kept in the official regulatory document room of the specific center assigned to an application.
9. I did not disclose Dr. Scher’s or Dr. Hussain’s letters to “a individuals outside of the FDA, or any media outlet, including a publication called ‘The Cancer Letter.’” See Attachment 1.
10.I did not write any portion of the letters that Drs. Scher, Hussain, or Fleming sent to the FDA.
11.I never received a copy of a letter from Dr. Thomas Fleming to the FDA regarding Provenge.
Pursuant to 28 U.S.C. § 1746, I declare under penalty of perjury that the foregoing is true and correct.
Executed on 15 day of May, 2009.
Dr. Richard Pazdur
Supervisory Medical Officer
Office of Oncology, CDER
And now for my initial comments after going through them the first time:
#1
"My duties include supervision of the Office of Oncology Drug Products, leading the FDA-wide oncology program, and coordinating oncology-related activities and the discussion of reviews of oncology products conducted in other Centers. The purpose of this program is to provide consistent and uniformity I the regulation of oncology-related products throughout the FDA."
How can he lead, coordinate and discuss and then later say it did not fall under his direct regulatory supervision and "did not require a response from him." Discuss and response are quite close, are they not? Are we to believe he did not discuss this or respond to the letters? FDA said they sided with the minority doctors, are not these doctors from Pazdur’s side of the FDA fence?
As for the consistent and uniformity, he publicly stated he approved Avastin even though it did not show survival because he said he felt sympathy for the patients. He said there was regulatory flexibility. He can say what he wants but he helped stop the approval of Provenge when it did show survival and he did not feel sorry for the 96,000 men who were inflicted with AIPC. No consistency whatsoever.
# 2
"The statements made in this declaration are based upon my personal knowledge and information about which I have become knowledgeable through my review of official agency records within CDER’s control."
That is a lie. He became knowledgeable when Scher and Hussain's letters and e-mails came his way.
# 5
He uses the Cancer Letter's published date of Maha's letter, April 27th.
He says he is listed as a “cc” recipient on the April 5, 2007 letters from Howard Scher. It is plural, letters, how many letters did he receive from Howie?
# 7
He says these letters related to a specific regulatory application conducted by a different FDA center, CBER, and did not fall under his direct regulatory supervision.
Oh, so now he is concerned about regulations. And, his first declaration says his duties include FDA-wide oncology program and discussing reviews of oncology products conducted in other Centers.
So why were Hussain and Scher, who are from his Center, even on the panel if this was just for CBER?
Why did he pass notes to Hussain?
Who tampered with the question?
Didn't he threaten a protest if Provenge got approved? Was it FDA-wide?
# 8
"I do not keep personal copies of any regulatory communications." This is scary to hear from a government worker. Why wouldn’t he keep these, especially for a case that the DOJ says is not ripe? If you have such an important position and are worried about specific regulatory applications, why not?
Oh, I see, the official copies or regulatory correspondence are kept in “the official regulatory document room.” Well, can we look in there for documents you may have missed? Are copies of all the ones you shredded and deleted in that room? What about the envelopes? Are they in that room?
# 9
He did not disclose Howie’s and Maha’s letters to "individuals outside the FDA". What about individuals inside the FDA? Maybe you gave them to someone inside and that person got them to the Cancer Letter and others outside the FDA?
My Overall Humble Opinion
This is all just a bunch of horse manure and lies. A complete waste of our tax dollars. And he is the cancer czar? He had something to say here. What a lying piece of garbage. If he knew he shredded the documents and deleted the e-mails “within a month of receipt,” on May 23 2007, why did he spend our tax dollars on DOJ representation, court costs and FOIA compliance people looking for something he already destroyed? He needs to go down!
Men læs selv - WSJ er begyndt at grave - og Kerry m fl graver med - jeg er meget spændt på hvad der kommer ud af det.
HER er en artikkel fra WSJ fra maj 2007 hvor man kan se en tilsvarende historie som DNDN's provenge - bare med et andet firma og præparat
http://online.wsj.com/article/SB117824324837591782.html?mod=opinion_main_commentaries
så Dndn var ikke ene om at blive skubbet uretmæssigt ud på sidelinjen på den måde.
------------
Ellers omkring aktien i nuet - så tror jeg der sker en konsolideringsfase nu kursmæssigt, hvor firmaet har en række møder hvor deres resultater og planer formidles, mens de ansætter folk til produktion - er nu 87 ledige stillinger - og "de store" langsomt bygger long positioner op, og der forhandles med en ROW partner.
Jeg holder fortsat mine aktier long - og er forberedt på at der godt kan blive stille i en periode, selvom der jo fortsat er en del triggere
Vh
Hya
19/5 2009 16:29 Hya 0
11551 hvortil jeg altid svarer - at det ikke udelukkende er de 4,5 mdr i snit smo livet forlænges med - der afgør at jeg se så hooked på denne form for behandling
men netop bivirkningsprofilen - hvor der er få eller slet ingen bivirkninger
som gør at folk kan fortsætte deres liv og hverdag - UDEN at skulle molstreres i den sidste tid af kemoterapiens bivirkninger og evt indlæggelse osv
DET handler om livskvalitet i og under behandlingen
jeg kan anbefale denne artikkel
http://www.nytimes.com/2009/05/17/health/policy/17untested.html?_r=1&scp=1&sq=fighting%20for%20a%20last%20chance&st=cse
Hya
men netop bivirkningsprofilen - hvor der er få eller slet ingen bivirkninger
som gør at folk kan fortsætte deres liv og hverdag - UDEN at skulle molstreres i den sidste tid af kemoterapiens bivirkninger og evt indlæggelse osv
DET handler om livskvalitet i og under behandlingen
jeg kan anbefale denne artikkel
http://www.nytimes.com/2009/05/17/health/policy/17untested.html?_r=1&scp=1&sq=fighting%20for%20a%20last%20chance&st=cse
Hya
20/5 2009 00:44 fillipa1 011603 Hej Hya...
Er du inde i Cell Genesys...og har du et par kommentar til Cege...
Hilsen
Fillipa
Er du inde i Cell Genesys...og har du et par kommentar til Cege...
Hilsen
Fillipa
20/5 2009 16:08 Hya 011674 http://www.xconomy.com/seattle/2009/05/20/dendreon-drug-works-but-can-it-manufacture-enough-to-meet-demand/
artikel efter konferencen med Deutsche bank igår
den ligger forøvrigt på dndn's hjemmeside med slides - og kan aflyttes
Hya
artikel efter konferencen med Deutsche bank igår
den ligger forøvrigt på dndn's hjemmeside med slides - og kan aflyttes
Hya
1/6 2009 01:52 alpehue 012551 DNDN længst fremme i udviklingen - lidt nyt
""The prostate cancer vaccine, Provenge, is farthest along. Its maker, Seattle-based Dendreon Corp., is seeking federal Food and Drug Administration approval for it. A study last month found that it extended survival by four months in men with very advanced disease.""
Overskrift:
>Immune therapies are finally starting to work against cancer after 30 years of false starts <
http://finance.yahoo.com/news/Immune-therapies-finally-apf-15393027.html?.v=2
Pyha - Hya
""The prostate cancer vaccine, Provenge, is farthest along. Its maker, Seattle-based Dendreon Corp., is seeking federal Food and Drug Administration approval for it. A study last month found that it extended survival by four months in men with very advanced disease.""
Overskrift:
>Immune therapies are finally starting to work against cancer after 30 years of false starts <
http://finance.yahoo.com/news/Immune-therapies-finally-apf-15393027.html?.v=2
Pyha - Hya
