Guest guest Posted March 10, 2004 Report Share Posted March 10, 2004 " Dear SSRI Citizen " Children of the United States need your help. TODAY Here's how you can help them. Right now. We promise this will only take about one minute of your time. Welcome ... to " One Minute Activism. " Its incredibly fast, easy, pain-free, costs nothing and best of all it works. How could it not with thousands of other people just like you who are doing the same thing right now! Think about it. Here's all you have to do. Are you ready? Let's go to a site called " Contacting The Congress " Click on this link: http://www.visi.com/juan/congress/cgi-bin/mailform2.cgi?site=ctc Fill in the form that appears. Type your first and last name, street address, city, state, zip. Now add your email address and phone number. When finished, click on the " button " beneath the " phone number " field. You'll be whisked to another web page. At the new web page that appears Click in the " Subject " field. Delete the " default " message: An Issue Of Concern To Me Paste (or type) the following text into the " Subject " box: SSRI's, Children's Suicides and The FDA Note: Pasted text will not appear in the " Subject " box until you click the " letter box " . Click in the " letter box " area below. Delete the default text that reads: I Am Contacting My Members Of Congress Now highlight, copy and paste the entire block of text provided below (between asterisked lines) into the same (letter box) field. ************************************************************** The Vetting of the FDA's SSRI Pediatric Columbia Group: Dr. Posner. Removal of Dr. Mann. View the entire FDA Meeting Transcript at: http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4006T1.htm " In our efforts to further evaluate the data, we have enlisted the help of outside experts with particular expertise in the issue of pediatric depression and suicide, and in particular, we have enlisted a group from Columbia University, who will objectively reclassify potential cases of suicidality from all the drug development programs, so that we may move forward with our more definitive analyses. You will hear about this from Dr. Posner in more detail later. " — Dr. Katz addressing the audience in opening remarks at the Monday, February 8th, 2004 FDA hearing regarding the use of SSRI's, suicidality and the pediatric population. Unless something dramatic occurs Dr. Posner will remain an integral part of the " Columbia group " referenced above in Dr. Katz's comments. Dr. Posner is responsible for coordinating the FDA's so called " Suicidality Classification Project. " By " dramatic " I mean to say: (if) disclosures of Dr. Posner's personal or family business interests reveal ties to the pharmaceutical company's whose drugs were the topic of discussion at this meeting. The public already knows this is the case with at least one member of the Columbia group whom Dr. Katz references: Dr. Mann. Just for starters, Dr. Mann testified on behalf of GlaxoKline (GSK) in what is known as " the Shell case. " In that case a jury — in a landmark decision — concluded ingestation of Paxil was the proximate cause of Mr. Shell's tragic actions ... whereby Mr. Shell shot to death members of his family before turning a gun on himself. Mr. Shell also died. GSK subsequently decided to appeal the verdict, but then on second thought decided not to. A transcript of this stunning trial as well as (shocking and disturbing) depositions of GSK personnel (including Wheadon) can be found at renowned SSRI expert Healy's web site: http://www.healyprozac.com While on the subject of Dr. Healy ... I implore you to read Dr. Healy's February 19th, 2004 letter to J. Pitts, Associate Commissioner For External Public Relations, FDA. At minimum, it should raise at least one of your eyebrows — about a mile high. A link to that letter can be found at: http://www.ahrp.org/risks/healy/FDA0204.html I also suggest reading the following letter from Tierney: http://www.baumhedlundlaw.com/media/ssri/paxil/FDAHearing/ TierneyLetter.htm But for the moment let's take a closer look at Dr. Posner. Just who is she? To begin with she actually goes by Dr. Posner-Gerstenhaber. Dr. Posner-Gerstenhaber graduated from Brown University with honors and went on to earn a Ph.D. in Clinical Psychology at Yeshiva University, after completing her doctoral research in pediatric oncology at the Memorial Sloan-Kettering Cancer Center. She then did an internship and fellowship at Babies' Hospital, Department of Child Psychiatry, Columbia-Presbyterian Medical Center. Dr. Posner-Gerstenhaber is a research scientist and the Director of Clinical Services of the Research Unit for Pediatric Psychopharmacology, at New York State Psychiatric Institute, Columbia University. In addition to her research responsibilities — which include running a number of pediatric clinical trials for industry and the NIMH — Dr. Gerstenhaber also teaches and directs a training program. QUESTIONS THAT MUST BE ADDRESSED BY DR. POSNER IMMEDIATELY AND IN DETAIL What pediatric trials? For which drug company(s)? What training program? For which drug company(s)? As part of an international research team (consisting of the neurology depts. of Harvard, Columbia, and others) Dr. Posner-Gerstenhaber traveled to Venezuela on multiple occasions. There she spear-headed the addition of something called " Evaluation Services, " and according to one source I have " made available greatly-needed psychotropic medications for (these) suffering children and adolescents. " MORE QUESTIONS THAT MUST BE ADDRESSED BY DR. POSNER IMMEDIATELY AND IN DETAIL: What did your spearheading of " Evaluation Services " entail? What is Evaluation Services? What entity or entities are behind Evaluation Services? Did you participate materially in studies conducted on children and adolescents in South America? If so, what kind of studies? Were parental consent forms used? Or were these runaway children scooped up off the the streets of a big city? Which " psychotropic medicines " were employed? Paxil? Prozac? Zoloft? Sponsored by which pharmaceutical company(s)? GSK? Lilly? Pfizer? What was your relationship to pharmaceutical company(s) that provided the drugs? What quantity of drugs were given, in what doses, and for how long? Did you handle just the " numbers crunching " -- or did you also hand out drugs? What was the age range of participants? What was the age of the youngest child dosed? 8? 5? 2? Six months? Were any of these drugs given to pregnant teens? How many participants were used? Were there suicides, whether akathasia-induced or withdrawal-induced? What sort of safety monitoring was in place to safeguard the health of participants? What sort of documentation occurred? Where is that documentation today? Can you provide any sound reasoning as to why you should not immediately and publicly answer all of these questions? In closing: Dr. Katz's own remarks are that the " reinterpretation " of the SSRI pediatric data in question will be done so in an " objective " manner. Therefore I am calling for the immediate removal of Dr. Mann from the " Columbia group, " and for the immediate and full vetting of Dr. Posner-Gerstenhaber. Furthermore, I am calling on FDA to immediately release all names of persons selected by Dr. Katz and his colleagues who have been selected as members of " the Columbia group. " Dr. Temple (an FDA colleague of Katz) promised he would do this in a timely manner. More than one month has passed and Dr. Temple has not made good on his promise. I am also demanding FDA make available — immediately — for public inspection its Contract For Services with Columbia University relative to the Suicide Reclassification Project currently headed by Dr. Posner. If you have any questions regarding the (alleged) objective review of the SSRI-pediatric-suicide data slated to be performed by " the Columbia group, " (Dr. Posner, Dr. Mann, et al) and member's ties to pharmaceutical companies — they should be directed ASAP to key FDA personnel as follows: Dr. Temple at: robert.temple@... Dr. Katz at: russell.katz@... Dr. Laughren at: thomas.laughren@... ************************************************************** You're almost through. Click on the button that reads " Preview And Send Your Message " A new web page appears. In the lower left hand corner click the button " Send Your Message Electronically " You're done! One Minute Activism! Our message is on its way to Congress! Now that you've helped send our message to Congress I want to give you something as a way of saying " thanks. " Select one of the following bumper stickers: Paxil: Unsafe At Any Dose Zoloft: Unsafe At Any Dose Prozac: Unsafe At Any Dose Send an email to chv@... and let us know which one you want. Please be sure to include a name and mailing address so we'll know where to send it! Thanks for helping make a difference. Please copy this email to everyone in your address book whom you think will take one minute to help. In memory of " Kara " ... a child who committed suicide less than 24 hours after beginning a horrific " cold turkey " withdrawal from the SSRI antidepressant drug " Paxil. " _________________________________________________________________ Get business advice and resources to improve your work life, from bCentral. http://special.msn.com/bcentral/loudclear.armx Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 10, 2004 Report Share Posted March 10, 2004 " Dear SSRI Citizen " Children of the United States need your help. TODAY Here's how you can help them. Right now. We promise this will only take about one minute of your time. Welcome ... to " One Minute Activism. " Its incredibly fast, easy, pain-free, costs nothing and best of all it works. How could it not with thousands of other people just like you who are doing the same thing right now! Think about it. Here's all you have to do. Are you ready? Let's go to a site called " Contacting The Congress " Click on this link: http://www.visi.com/juan/congress/cgi-bin/mailform2.cgi?site=ctc Fill in the form that appears. Type your first and last name, street address, city, state, zip. Now add your email address and phone number. When finished, click on the " button " beneath the " phone number " field. You'll be whisked to another web page. At the new web page that appears Click in the " Subject " field. Delete the " default " message: An Issue Of Concern To Me Paste (or type) the following text into the " Subject " box: SSRI's, Children's Suicides and The FDA Note: Pasted text will not appear in the " Subject " box until you click the " letter box " . Click in the " letter box " area below. Delete the default text that reads: I Am Contacting My Members Of Congress Now highlight, copy and paste the entire block of text provided below (between asterisked lines) into the same (letter box) field. ************************************************************** The Vetting of the FDA's SSRI Pediatric Columbia Group: Dr. Posner. Removal of Dr. Mann. View the entire FDA Meeting Transcript at: http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4006T1.htm " In our efforts to further evaluate the data, we have enlisted the help of outside experts with particular expertise in the issue of pediatric depression and suicide, and in particular, we have enlisted a group from Columbia University, who will objectively reclassify potential cases of suicidality from all the drug development programs, so that we may move forward with our more definitive analyses. You will hear about this from Dr. Posner in more detail later. " — Dr. Katz addressing the audience in opening remarks at the Monday, February 8th, 2004 FDA hearing regarding the use of SSRI's, suicidality and the pediatric population. Unless something dramatic occurs Dr. Posner will remain an integral part of the " Columbia group " referenced above in Dr. Katz's comments. Dr. Posner is responsible for coordinating the FDA's so called " Suicidality Classification Project. " By " dramatic " I mean to say: (if) disclosures of Dr. Posner's personal or family business interests reveal ties to the pharmaceutical company's whose drugs were the topic of discussion at this meeting. The public already knows this is the case with at least one member of the Columbia group whom Dr. Katz references: Dr. Mann. Just for starters, Dr. Mann testified on behalf of GlaxoKline (GSK) in what is known as " the Shell case. " In that case a jury — in a landmark decision — concluded ingestation of Paxil was the proximate cause of Mr. Shell's tragic actions ... whereby Mr. Shell shot to death members of his family before turning a gun on himself. Mr. Shell also died. GSK subsequently decided to appeal the verdict, but then on second thought decided not to. A transcript of this stunning trial as well as (shocking and disturbing) depositions of GSK personnel (including Wheadon) can be found at renowned SSRI expert Healy's web site: http://www.healyprozac.com While on the subject of Dr. Healy ... I implore you to read Dr. Healy's February 19th, 2004 letter to J. Pitts, Associate Commissioner For External Public Relations, FDA. At minimum, it should raise at least one of your eyebrows — about a mile high. A link to that letter can be found at: http://www.ahrp.org/risks/healy/FDA0204.html I also suggest reading the following letter from Tierney: http://www.baumhedlundlaw.com/media/ssri/paxil/FDAHearing/ TierneyLetter.htm But for the moment let's take a closer look at Dr. Posner. Just who is she? To begin with she actually goes by Dr. Posner-Gerstenhaber. Dr. Posner-Gerstenhaber graduated from Brown University with honors and went on to earn a Ph.D. in Clinical Psychology at Yeshiva University, after completing her doctoral research in pediatric oncology at the Memorial Sloan-Kettering Cancer Center. She then did an internship and fellowship at Babies' Hospital, Department of Child Psychiatry, Columbia-Presbyterian Medical Center. Dr. Posner-Gerstenhaber is a research scientist and the Director of Clinical Services of the Research Unit for Pediatric Psychopharmacology, at New York State Psychiatric Institute, Columbia University. In addition to her research responsibilities — which include running a number of pediatric clinical trials for industry and the NIMH — Dr. Gerstenhaber also teaches and directs a training program. QUESTIONS THAT MUST BE ADDRESSED BY DR. POSNER IMMEDIATELY AND IN DETAIL What pediatric trials? For which drug company(s)? What training program? For which drug company(s)? As part of an international research team (consisting of the neurology depts. of Harvard, Columbia, and others) Dr. Posner-Gerstenhaber traveled to Venezuela on multiple occasions. There she spear-headed the addition of something called " Evaluation Services, " and according to one source I have " made available greatly-needed psychotropic medications for (these) suffering children and adolescents. " MORE QUESTIONS THAT MUST BE ADDRESSED BY DR. POSNER IMMEDIATELY AND IN DETAIL: What did your spearheading of " Evaluation Services " entail? What is Evaluation Services? What entity or entities are behind Evaluation Services? Did you participate materially in studies conducted on children and adolescents in South America? If so, what kind of studies? Were parental consent forms used? Or were these runaway children scooped up off the the streets of a big city? Which " psychotropic medicines " were employed? Paxil? Prozac? Zoloft? Sponsored by which pharmaceutical company(s)? GSK? Lilly? Pfizer? What was your relationship to pharmaceutical company(s) that provided the drugs? What quantity of drugs were given, in what doses, and for how long? Did you handle just the " numbers crunching " -- or did you also hand out drugs? What was the age range of participants? What was the age of the youngest child dosed? 8? 5? 2? Six months? Were any of these drugs given to pregnant teens? How many participants were used? Were there suicides, whether akathasia-induced or withdrawal-induced? What sort of safety monitoring was in place to safeguard the health of participants? What sort of documentation occurred? Where is that documentation today? Can you provide any sound reasoning as to why you should not immediately and publicly answer all of these questions? In closing: Dr. Katz's own remarks are that the " reinterpretation " of the SSRI pediatric data in question will be done so in an " objective " manner. Therefore I am calling for the immediate removal of Dr. Mann from the " Columbia group, " and for the immediate and full vetting of Dr. Posner-Gerstenhaber. Furthermore, I am calling on FDA to immediately release all names of persons selected by Dr. Katz and his colleagues who have been selected as members of " the Columbia group. " Dr. Temple (an FDA colleague of Katz) promised he would do this in a timely manner. More than one month has passed and Dr. Temple has not made good on his promise. I am also demanding FDA make available — immediately — for public inspection its Contract For Services with Columbia University relative to the Suicide Reclassification Project currently headed by Dr. Posner. If you have any questions regarding the (alleged) objective review of the SSRI-pediatric-suicide data slated to be performed by " the Columbia group, " (Dr. Posner, Dr. Mann, et al) and member's ties to pharmaceutical companies — they should be directed ASAP to key FDA personnel as follows: Dr. Temple at: robert.temple@... Dr. Katz at: russell.katz@... Dr. Laughren at: thomas.laughren@... ************************************************************** You're almost through. Click on the button that reads " Preview And Send Your Message " A new web page appears. In the lower left hand corner click the button " Send Your Message Electronically " You're done! One Minute Activism! Our message is on its way to Congress! Now that you've helped send our message to Congress I want to give you something as a way of saying " thanks. " Select one of the following bumper stickers: Paxil: Unsafe At Any Dose Zoloft: Unsafe At Any Dose Prozac: Unsafe At Any Dose Send an email to chv@... and let us know which one you want. Please be sure to include a name and mailing address so we'll know where to send it! Thanks for helping make a difference. Please copy this email to everyone in your address book whom you think will take one minute to help. In memory of " Kara " ... a child who committed suicide less than 24 hours after beginning a horrific " cold turkey " withdrawal from the SSRI antidepressant drug " Paxil. " _________________________________________________________________ Get business advice and resources to improve your work life, from bCentral. http://special.msn.com/bcentral/loudclear.armx Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 10, 2004 Report Share Posted March 10, 2004 " Dear SSRI Citizen " Children of the United States need your help. TODAY Here's how you can help them. Right now. We promise this will only take about one minute of your time. Welcome ... to " One Minute Activism. " Its incredibly fast, easy, pain-free, costs nothing and best of all it works. How could it not with thousands of other people just like you who are doing the same thing right now! Think about it. Here's all you have to do. Are you ready? Let's go to a site called " Contacting The Congress " Click on this link: http://www.visi.com/juan/congress/cgi-bin/mailform2.cgi?site=ctc Fill in the form that appears. Type your first and last name, street address, city, state, zip. Now add your email address and phone number. When finished, click on the " button " beneath the " phone number " field. You'll be whisked to another web page. At the new web page that appears Click in the " Subject " field. Delete the " default " message: An Issue Of Concern To Me Paste (or type) the following text into the " Subject " box: SSRI's, Children's Suicides and The FDA Note: Pasted text will not appear in the " Subject " box until you click the " letter box " . Click in the " letter box " area below. Delete the default text that reads: I Am Contacting My Members Of Congress Now highlight, copy and paste the entire block of text provided below (between asterisked lines) into the same (letter box) field. ************************************************************** The Vetting of the FDA's SSRI Pediatric Columbia Group: Dr. Posner. Removal of Dr. Mann. View the entire FDA Meeting Transcript at: http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4006T1.htm " In our efforts to further evaluate the data, we have enlisted the help of outside experts with particular expertise in the issue of pediatric depression and suicide, and in particular, we have enlisted a group from Columbia University, who will objectively reclassify potential cases of suicidality from all the drug development programs, so that we may move forward with our more definitive analyses. You will hear about this from Dr. Posner in more detail later. " — Dr. Katz addressing the audience in opening remarks at the Monday, February 8th, 2004 FDA hearing regarding the use of SSRI's, suicidality and the pediatric population. Unless something dramatic occurs Dr. Posner will remain an integral part of the " Columbia group " referenced above in Dr. Katz's comments. Dr. Posner is responsible for coordinating the FDA's so called " Suicidality Classification Project. " By " dramatic " I mean to say: (if) disclosures of Dr. Posner's personal or family business interests reveal ties to the pharmaceutical company's whose drugs were the topic of discussion at this meeting. The public already knows this is the case with at least one member of the Columbia group whom Dr. Katz references: Dr. Mann. Just for starters, Dr. Mann testified on behalf of GlaxoKline (GSK) in what is known as " the Shell case. " In that case a jury — in a landmark decision — concluded ingestation of Paxil was the proximate cause of Mr. Shell's tragic actions ... whereby Mr. Shell shot to death members of his family before turning a gun on himself. Mr. Shell also died. GSK subsequently decided to appeal the verdict, but then on second thought decided not to. A transcript of this stunning trial as well as (shocking and disturbing) depositions of GSK personnel (including Wheadon) can be found at renowned SSRI expert Healy's web site: http://www.healyprozac.com While on the subject of Dr. Healy ... I implore you to read Dr. Healy's February 19th, 2004 letter to J. Pitts, Associate Commissioner For External Public Relations, FDA. At minimum, it should raise at least one of your eyebrows — about a mile high. A link to that letter can be found at: http://www.ahrp.org/risks/healy/FDA0204.html I also suggest reading the following letter from Tierney: http://www.baumhedlundlaw.com/media/ssri/paxil/FDAHearing/ TierneyLetter.htm But for the moment let's take a closer look at Dr. Posner. Just who is she? To begin with she actually goes by Dr. Posner-Gerstenhaber. Dr. Posner-Gerstenhaber graduated from Brown University with honors and went on to earn a Ph.D. in Clinical Psychology at Yeshiva University, after completing her doctoral research in pediatric oncology at the Memorial Sloan-Kettering Cancer Center. She then did an internship and fellowship at Babies' Hospital, Department of Child Psychiatry, Columbia-Presbyterian Medical Center. Dr. Posner-Gerstenhaber is a research scientist and the Director of Clinical Services of the Research Unit for Pediatric Psychopharmacology, at New York State Psychiatric Institute, Columbia University. In addition to her research responsibilities — which include running a number of pediatric clinical trials for industry and the NIMH — Dr. Gerstenhaber also teaches and directs a training program. QUESTIONS THAT MUST BE ADDRESSED BY DR. POSNER IMMEDIATELY AND IN DETAIL What pediatric trials? For which drug company(s)? What training program? For which drug company(s)? As part of an international research team (consisting of the neurology depts. of Harvard, Columbia, and others) Dr. Posner-Gerstenhaber traveled to Venezuela on multiple occasions. There she spear-headed the addition of something called " Evaluation Services, " and according to one source I have " made available greatly-needed psychotropic medications for (these) suffering children and adolescents. " MORE QUESTIONS THAT MUST BE ADDRESSED BY DR. POSNER IMMEDIATELY AND IN DETAIL: What did your spearheading of " Evaluation Services " entail? What is Evaluation Services? What entity or entities are behind Evaluation Services? Did you participate materially in studies conducted on children and adolescents in South America? If so, what kind of studies? Were parental consent forms used? Or were these runaway children scooped up off the the streets of a big city? Which " psychotropic medicines " were employed? Paxil? Prozac? Zoloft? Sponsored by which pharmaceutical company(s)? GSK? Lilly? Pfizer? What was your relationship to pharmaceutical company(s) that provided the drugs? What quantity of drugs were given, in what doses, and for how long? Did you handle just the " numbers crunching " -- or did you also hand out drugs? What was the age range of participants? What was the age of the youngest child dosed? 8? 5? 2? Six months? Were any of these drugs given to pregnant teens? How many participants were used? Were there suicides, whether akathasia-induced or withdrawal-induced? What sort of safety monitoring was in place to safeguard the health of participants? What sort of documentation occurred? Where is that documentation today? Can you provide any sound reasoning as to why you should not immediately and publicly answer all of these questions? In closing: Dr. Katz's own remarks are that the " reinterpretation " of the SSRI pediatric data in question will be done so in an " objective " manner. Therefore I am calling for the immediate removal of Dr. Mann from the " Columbia group, " and for the immediate and full vetting of Dr. Posner-Gerstenhaber. Furthermore, I am calling on FDA to immediately release all names of persons selected by Dr. Katz and his colleagues who have been selected as members of " the Columbia group. " Dr. Temple (an FDA colleague of Katz) promised he would do this in a timely manner. More than one month has passed and Dr. Temple has not made good on his promise. I am also demanding FDA make available — immediately — for public inspection its Contract For Services with Columbia University relative to the Suicide Reclassification Project currently headed by Dr. Posner. If you have any questions regarding the (alleged) objective review of the SSRI-pediatric-suicide data slated to be performed by " the Columbia group, " (Dr. Posner, Dr. Mann, et al) and member's ties to pharmaceutical companies — they should be directed ASAP to key FDA personnel as follows: Dr. Temple at: robert.temple@... Dr. Katz at: russell.katz@... Dr. Laughren at: thomas.laughren@... ************************************************************** You're almost through. Click on the button that reads " Preview And Send Your Message " A new web page appears. In the lower left hand corner click the button " Send Your Message Electronically " You're done! One Minute Activism! Our message is on its way to Congress! Now that you've helped send our message to Congress I want to give you something as a way of saying " thanks. " Select one of the following bumper stickers: Paxil: Unsafe At Any Dose Zoloft: Unsafe At Any Dose Prozac: Unsafe At Any Dose Send an email to chv@... and let us know which one you want. Please be sure to include a name and mailing address so we'll know where to send it! Thanks for helping make a difference. Please copy this email to everyone in your address book whom you think will take one minute to help. In memory of " Kara " ... a child who committed suicide less than 24 hours after beginning a horrific " cold turkey " withdrawal from the SSRI antidepressant drug " Paxil. " _________________________________________________________________ Get business advice and resources to improve your work life, from bCentral. http://special.msn.com/bcentral/loudclear.armx Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 10, 2004 Report Share Posted March 10, 2004 " Dear SSRI Citizen " Children of the United States need your help. TODAY Here's how you can help them. Right now. We promise this will only take about one minute of your time. Welcome ... to " One Minute Activism. " Its incredibly fast, easy, pain-free, costs nothing and best of all it works. How could it not with thousands of other people just like you who are doing the same thing right now! Think about it. Here's all you have to do. Are you ready? Let's go to a site called " Contacting The Congress " Click on this link: http://www.visi.com/juan/congress/cgi-bin/mailform2.cgi?site=ctc Fill in the form that appears. Type your first and last name, street address, city, state, zip. Now add your email address and phone number. When finished, click on the " button " beneath the " phone number " field. You'll be whisked to another web page. At the new web page that appears Click in the " Subject " field. Delete the " default " message: An Issue Of Concern To Me Paste (or type) the following text into the " Subject " box: SSRI's, Children's Suicides and The FDA Note: Pasted text will not appear in the " Subject " box until you click the " letter box " . Click in the " letter box " area below. Delete the default text that reads: I Am Contacting My Members Of Congress Now highlight, copy and paste the entire block of text provided below (between asterisked lines) into the same (letter box) field. ************************************************************** The Vetting of the FDA's SSRI Pediatric Columbia Group: Dr. Posner. Removal of Dr. Mann. View the entire FDA Meeting Transcript at: http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4006T1.htm " In our efforts to further evaluate the data, we have enlisted the help of outside experts with particular expertise in the issue of pediatric depression and suicide, and in particular, we have enlisted a group from Columbia University, who will objectively reclassify potential cases of suicidality from all the drug development programs, so that we may move forward with our more definitive analyses. You will hear about this from Dr. Posner in more detail later. " — Dr. Katz addressing the audience in opening remarks at the Monday, February 8th, 2004 FDA hearing regarding the use of SSRI's, suicidality and the pediatric population. Unless something dramatic occurs Dr. Posner will remain an integral part of the " Columbia group " referenced above in Dr. Katz's comments. Dr. Posner is responsible for coordinating the FDA's so called " Suicidality Classification Project. " By " dramatic " I mean to say: (if) disclosures of Dr. Posner's personal or family business interests reveal ties to the pharmaceutical company's whose drugs were the topic of discussion at this meeting. The public already knows this is the case with at least one member of the Columbia group whom Dr. Katz references: Dr. Mann. Just for starters, Dr. Mann testified on behalf of GlaxoKline (GSK) in what is known as " the Shell case. " In that case a jury — in a landmark decision — concluded ingestation of Paxil was the proximate cause of Mr. Shell's tragic actions ... whereby Mr. Shell shot to death members of his family before turning a gun on himself. Mr. Shell also died. GSK subsequently decided to appeal the verdict, but then on second thought decided not to. A transcript of this stunning trial as well as (shocking and disturbing) depositions of GSK personnel (including Wheadon) can be found at renowned SSRI expert Healy's web site: http://www.healyprozac.com While on the subject of Dr. Healy ... I implore you to read Dr. Healy's February 19th, 2004 letter to J. Pitts, Associate Commissioner For External Public Relations, FDA. At minimum, it should raise at least one of your eyebrows — about a mile high. A link to that letter can be found at: http://www.ahrp.org/risks/healy/FDA0204.html I also suggest reading the following letter from Tierney: http://www.baumhedlundlaw.com/media/ssri/paxil/FDAHearing/ TierneyLetter.htm But for the moment let's take a closer look at Dr. Posner. Just who is she? To begin with she actually goes by Dr. Posner-Gerstenhaber. Dr. Posner-Gerstenhaber graduated from Brown University with honors and went on to earn a Ph.D. in Clinical Psychology at Yeshiva University, after completing her doctoral research in pediatric oncology at the Memorial Sloan-Kettering Cancer Center. She then did an internship and fellowship at Babies' Hospital, Department of Child Psychiatry, Columbia-Presbyterian Medical Center. Dr. Posner-Gerstenhaber is a research scientist and the Director of Clinical Services of the Research Unit for Pediatric Psychopharmacology, at New York State Psychiatric Institute, Columbia University. In addition to her research responsibilities — which include running a number of pediatric clinical trials for industry and the NIMH — Dr. Gerstenhaber also teaches and directs a training program. QUESTIONS THAT MUST BE ADDRESSED BY DR. POSNER IMMEDIATELY AND IN DETAIL What pediatric trials? For which drug company(s)? What training program? For which drug company(s)? As part of an international research team (consisting of the neurology depts. of Harvard, Columbia, and others) Dr. Posner-Gerstenhaber traveled to Venezuela on multiple occasions. There she spear-headed the addition of something called " Evaluation Services, " and according to one source I have " made available greatly-needed psychotropic medications for (these) suffering children and adolescents. " MORE QUESTIONS THAT MUST BE ADDRESSED BY DR. POSNER IMMEDIATELY AND IN DETAIL: What did your spearheading of " Evaluation Services " entail? What is Evaluation Services? What entity or entities are behind Evaluation Services? Did you participate materially in studies conducted on children and adolescents in South America? If so, what kind of studies? Were parental consent forms used? Or were these runaway children scooped up off the the streets of a big city? Which " psychotropic medicines " were employed? Paxil? Prozac? Zoloft? Sponsored by which pharmaceutical company(s)? GSK? Lilly? Pfizer? What was your relationship to pharmaceutical company(s) that provided the drugs? What quantity of drugs were given, in what doses, and for how long? Did you handle just the " numbers crunching " -- or did you also hand out drugs? What was the age range of participants? What was the age of the youngest child dosed? 8? 5? 2? Six months? Were any of these drugs given to pregnant teens? How many participants were used? Were there suicides, whether akathasia-induced or withdrawal-induced? What sort of safety monitoring was in place to safeguard the health of participants? What sort of documentation occurred? Where is that documentation today? Can you provide any sound reasoning as to why you should not immediately and publicly answer all of these questions? In closing: Dr. Katz's own remarks are that the " reinterpretation " of the SSRI pediatric data in question will be done so in an " objective " manner. Therefore I am calling for the immediate removal of Dr. Mann from the " Columbia group, " and for the immediate and full vetting of Dr. Posner-Gerstenhaber. Furthermore, I am calling on FDA to immediately release all names of persons selected by Dr. Katz and his colleagues who have been selected as members of " the Columbia group. " Dr. Temple (an FDA colleague of Katz) promised he would do this in a timely manner. More than one month has passed and Dr. Temple has not made good on his promise. I am also demanding FDA make available — immediately — for public inspection its Contract For Services with Columbia University relative to the Suicide Reclassification Project currently headed by Dr. Posner. If you have any questions regarding the (alleged) objective review of the SSRI-pediatric-suicide data slated to be performed by " the Columbia group, " (Dr. Posner, Dr. Mann, et al) and member's ties to pharmaceutical companies — they should be directed ASAP to key FDA personnel as follows: Dr. Temple at: robert.temple@... Dr. Katz at: russell.katz@... Dr. Laughren at: thomas.laughren@... ************************************************************** You're almost through. Click on the button that reads " Preview And Send Your Message " A new web page appears. In the lower left hand corner click the button " Send Your Message Electronically " You're done! One Minute Activism! Our message is on its way to Congress! Now that you've helped send our message to Congress I want to give you something as a way of saying " thanks. " Select one of the following bumper stickers: Paxil: Unsafe At Any Dose Zoloft: Unsafe At Any Dose Prozac: Unsafe At Any Dose Send an email to chv@... and let us know which one you want. Please be sure to include a name and mailing address so we'll know where to send it! Thanks for helping make a difference. Please copy this email to everyone in your address book whom you think will take one minute to help. In memory of " Kara " ... a child who committed suicide less than 24 hours after beginning a horrific " cold turkey " withdrawal from the SSRI antidepressant drug " Paxil. " _________________________________________________________________ Get business advice and resources to improve your work life, from bCentral. http://special.msn.com/bcentral/loudclear.armx Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 10, 2004 Report Share Posted March 10, 2004 Done! I also sent this forward to my parents and friends. Jim SSRI's, Children's Suicides and The FDA " Dear SSRI Citizen " Children of the United States need your help. TODAY Here's how you can help them. Right now. We promise this will only take about one minute of your time. Welcome ... to " One Minute Activism. " Its incredibly fast, easy, pain-free, costs nothing and best of all it works. How could it not with thousands of other people just like you who are doing the same thing right now! Think about it. Here's all you have to do. Are you ready? Let's go to a site called " Contacting The Congress " Click on this link: http://www.visi.com/juan/congress/cgi-bin/mailform2.cgi?site=ctc Fill in the form that appears. Type your first and last name, street address, city, state, zip. Now add your email address and phone number. When finished, click on the " button " beneath the " phone number " field. You'll be whisked to another web page. At the new web page that appears Click in the " Subject " field. Delete the " default " message: An Issue Of Concern To Me Paste (or type) the following text into the " Subject " box: SSRI's, Children's Suicides and The FDA Note: Pasted text will not appear in the " Subject " box until you click the " letter box " . Click in the " letter box " area below. Delete the default text that reads: I Am Contacting My Members Of Congress Now highlight, copy and paste the entire block of text provided below (between asterisked lines) into the same (letter box) field. ************************************************************** The Vetting of the FDA's SSRI Pediatric Columbia Group: Dr. Posner. Removal of Dr. Mann. View the entire FDA Meeting Transcript at: http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4006T1.htm " In our efforts to further evaluate the data, we have enlisted the help of outside experts with particular expertise in the issue of pediatric depression and suicide, and in particular, we have enlisted a group from Columbia University, who will objectively reclassify potential cases of suicidality from all the drug development programs, so that we may move forward with our more definitive analyses. You will hear about this from Dr. Posner in more detail later. " - Dr. Katz addressing the audience in opening remarks at the Monday, February 8th, 2004 FDA hearing regarding the use of SSRI's, suicidality and the pediatric population. Unless something dramatic occurs Dr. Posner will remain an integral part of the " Columbia group " referenced above in Dr. Katz's comments. Dr. Posner is responsible for coordinating the FDA's so called " Suicidality Classification Project. " By " dramatic " I mean to say: (if) disclosures of Dr. Posner's personal or family business interests reveal ties to the pharmaceutical company's whose drugs were the topic of discussion at this meeting. The public already knows this is the case with at least one member of the Columbia group whom Dr. Katz references: Dr. Mann. Just for starters, Dr. Mann testified on behalf of GlaxoKline (GSK) in what is known as " the Shell case. " In that case a jury - in a landmark decision - concluded ingestation of Paxil was the proximate cause of Mr. Shell's tragic actions ... whereby Mr. Shell shot to death members of his family before turning a gun on himself. Mr. Shell also died. GSK subsequently decided to appeal the verdict, but then on second thought decided not to. A transcript of this stunning trial as well as (shocking and disturbing) depositions of GSK personnel (including Wheadon) can be found at renowned SSRI expert Healy's web site: http://www.healyprozac.com While on the subject of Dr. Healy ... I implore you to read Dr. Healy's February 19th, 2004 letter to J. Pitts, Associate Commissioner For External Public Relations, FDA. At minimum, it should raise at least one of your eyebrows - about a mile high. A link to that letter can be found at: http://www.ahrp.org/risks/healy/FDA0204.html I also suggest reading the following letter from Tierney: http://www.baumhedlundlaw.com/media/ssri/paxil/FDAHearing/ TierneyLetter.htm But for the moment let's take a closer look at Dr. Posner. Just who is she? To begin with she actually goes by Dr. Posner-Gerstenhaber. Dr. Posner-Gerstenhaber graduated from Brown University with honors and went on to earn a Ph.D. in Clinical Psychology at Yeshiva University, after completing her doctoral research in pediatric oncology at the Memorial Sloan-Kettering Cancer Center. She then did an internship and fellowship at Babies' Hospital, Department of Child Psychiatry, Columbia-Presbyterian Medical Center. Dr. Posner-Gerstenhaber is a research scientist and the Director of Clinical Services of the Research Unit for Pediatric Psychopharmacology, at New York State Psychiatric Institute, Columbia University. In addition to her research responsibilities - which include running a number of pediatric clinical trials for industry and the NIMH - Dr. Gerstenhaber also teaches and directs a training program. QUESTIONS THAT MUST BE ADDRESSED BY DR. POSNER IMMEDIATELY AND IN DETAIL What pediatric trials? For which drug company(s)? What training program? For which drug company(s)? As part of an international research team (consisting of the neurology depts. of Harvard, Columbia, and others) Dr. Posner-Gerstenhaber traveled to Venezuela on multiple occasions. There she spear-headed the addition of something called " Evaluation Services, " and according to one source I have " made available greatly-needed psychotropic medications for (these) suffering children and adolescents. " MORE QUESTIONS THAT MUST BE ADDRESSED BY DR. POSNER IMMEDIATELY AND IN DETAIL: What did your spearheading of " Evaluation Services " entail? What is Evaluation Services? What entity or entities are behind Evaluation Services? Did you participate materially in studies conducted on children and adolescents in South America? If so, what kind of studies? Were parental consent forms used? Or were these runaway children scooped up off the the streets of a big city? Which " psychotropic medicines " were employed? Paxil? Prozac? Zoloft? Sponsored by which pharmaceutical company(s)? GSK? Lilly? Pfizer? What was your relationship to pharmaceutical company(s) that provided the drugs? What quantity of drugs were given, in what doses, and for how long? Did you handle just the " numbers crunching " -- or did you also hand out drugs? What was the age range of participants? What was the age of the youngest child dosed? 8? 5? 2? Six months? Were any of these drugs given to pregnant teens? How many participants were used? Were there suicides, whether akathasia-induced or withdrawal-induced? What sort of safety monitoring was in place to safeguard the health of participants? What sort of documentation occurred? Where is that documentation today? Can you provide any sound reasoning as to why you should not immediately and publicly answer all of these questions? In closing: Dr. Katz's own remarks are that the " reinterpretation " of the SSRI pediatric data in question will be done so in an " objective " manner. Therefore I am calling for the immediate removal of Dr. Mann from the " Columbia group, " and for the immediate and full vetting of Dr. Posner-Gerstenhaber. Furthermore, I am calling on FDA to immediately release all names of persons selected by Dr. Katz and his colleagues who have been selected as members of " the Columbia group. " Dr. Temple (an FDA colleague of Katz) promised he would do this in a timely manner. More than one month has passed and Dr. Temple has not made good on his promise. I am also demanding FDA make available - immediately - for public inspection its Contract For Services with Columbia University relative to the Suicide Reclassification Project currently headed by Dr. Posner. If you have any questions regarding the (alleged) objective review of the SSRI-pediatric-suicide data slated to be performed by " the Columbia group, " (Dr. Posner, Dr. Mann, et al) and member's ties to pharmaceutical companies - they should be directed ASAP to key FDA personnel as follows: Dr. Temple at: robert.temple@... Dr. Katz at: russell.katz@... Dr. Laughren at: thomas.laughren@... ************************************************************** You're almost through. Click on the button that reads " Preview And Send Your Message " A new web page appears. In the lower left hand corner click the button " Send Your Message Electronically " You're done! One Minute Activism! Our message is on its way to Congress! Now that you've helped send our message to Congress I want to give you something as a way of saying " thanks. " Select one of the following bumper stickers: Paxil: Unsafe At Any Dose Zoloft: Unsafe At Any Dose Prozac: Unsafe At Any Dose Send an email to chv@... and let us know which one you want. Please be sure to include a name and mailing address so we'll know where to send it! Thanks for helping make a difference. Please copy this email to everyone in your address book whom you think will take one minute to help. In memory of " Kara " ... a child who committed suicide less than 24 hours after beginning a horrific " cold turkey " withdrawal from the SSRI antidepressant drug " Paxil. " _________________________________________________________________ Get business advice and resources to improve your work life, from bCentral. http://special.msn.com/bcentral/loudclear.armx Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 10, 2004 Report Share Posted March 10, 2004 Done! I also sent this forward to my parents and friends. Jim SSRI's, Children's Suicides and The FDA " Dear SSRI Citizen " Children of the United States need your help. TODAY Here's how you can help them. Right now. We promise this will only take about one minute of your time. Welcome ... to " One Minute Activism. " Its incredibly fast, easy, pain-free, costs nothing and best of all it works. How could it not with thousands of other people just like you who are doing the same thing right now! Think about it. Here's all you have to do. Are you ready? Let's go to a site called " Contacting The Congress " Click on this link: http://www.visi.com/juan/congress/cgi-bin/mailform2.cgi?site=ctc Fill in the form that appears. Type your first and last name, street address, city, state, zip. Now add your email address and phone number. When finished, click on the " button " beneath the " phone number " field. You'll be whisked to another web page. At the new web page that appears Click in the " Subject " field. Delete the " default " message: An Issue Of Concern To Me Paste (or type) the following text into the " Subject " box: SSRI's, Children's Suicides and The FDA Note: Pasted text will not appear in the " Subject " box until you click the " letter box " . Click in the " letter box " area below. Delete the default text that reads: I Am Contacting My Members Of Congress Now highlight, copy and paste the entire block of text provided below (between asterisked lines) into the same (letter box) field. ************************************************************** The Vetting of the FDA's SSRI Pediatric Columbia Group: Dr. Posner. Removal of Dr. Mann. View the entire FDA Meeting Transcript at: http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4006T1.htm " In our efforts to further evaluate the data, we have enlisted the help of outside experts with particular expertise in the issue of pediatric depression and suicide, and in particular, we have enlisted a group from Columbia University, who will objectively reclassify potential cases of suicidality from all the drug development programs, so that we may move forward with our more definitive analyses. You will hear about this from Dr. Posner in more detail later. " - Dr. Katz addressing the audience in opening remarks at the Monday, February 8th, 2004 FDA hearing regarding the use of SSRI's, suicidality and the pediatric population. Unless something dramatic occurs Dr. Posner will remain an integral part of the " Columbia group " referenced above in Dr. Katz's comments. Dr. Posner is responsible for coordinating the FDA's so called " Suicidality Classification Project. " By " dramatic " I mean to say: (if) disclosures of Dr. Posner's personal or family business interests reveal ties to the pharmaceutical company's whose drugs were the topic of discussion at this meeting. The public already knows this is the case with at least one member of the Columbia group whom Dr. Katz references: Dr. Mann. Just for starters, Dr. Mann testified on behalf of GlaxoKline (GSK) in what is known as " the Shell case. " In that case a jury - in a landmark decision - concluded ingestation of Paxil was the proximate cause of Mr. Shell's tragic actions ... whereby Mr. Shell shot to death members of his family before turning a gun on himself. Mr. Shell also died. GSK subsequently decided to appeal the verdict, but then on second thought decided not to. A transcript of this stunning trial as well as (shocking and disturbing) depositions of GSK personnel (including Wheadon) can be found at renowned SSRI expert Healy's web site: http://www.healyprozac.com While on the subject of Dr. Healy ... I implore you to read Dr. Healy's February 19th, 2004 letter to J. Pitts, Associate Commissioner For External Public Relations, FDA. At minimum, it should raise at least one of your eyebrows - about a mile high. A link to that letter can be found at: http://www.ahrp.org/risks/healy/FDA0204.html I also suggest reading the following letter from Tierney: http://www.baumhedlundlaw.com/media/ssri/paxil/FDAHearing/ TierneyLetter.htm But for the moment let's take a closer look at Dr. Posner. Just who is she? To begin with she actually goes by Dr. Posner-Gerstenhaber. Dr. Posner-Gerstenhaber graduated from Brown University with honors and went on to earn a Ph.D. in Clinical Psychology at Yeshiva University, after completing her doctoral research in pediatric oncology at the Memorial Sloan-Kettering Cancer Center. She then did an internship and fellowship at Babies' Hospital, Department of Child Psychiatry, Columbia-Presbyterian Medical Center. Dr. Posner-Gerstenhaber is a research scientist and the Director of Clinical Services of the Research Unit for Pediatric Psychopharmacology, at New York State Psychiatric Institute, Columbia University. In addition to her research responsibilities - which include running a number of pediatric clinical trials for industry and the NIMH - Dr. Gerstenhaber also teaches and directs a training program. QUESTIONS THAT MUST BE ADDRESSED BY DR. POSNER IMMEDIATELY AND IN DETAIL What pediatric trials? For which drug company(s)? What training program? For which drug company(s)? As part of an international research team (consisting of the neurology depts. of Harvard, Columbia, and others) Dr. Posner-Gerstenhaber traveled to Venezuela on multiple occasions. There she spear-headed the addition of something called " Evaluation Services, " and according to one source I have " made available greatly-needed psychotropic medications for (these) suffering children and adolescents. " MORE QUESTIONS THAT MUST BE ADDRESSED BY DR. POSNER IMMEDIATELY AND IN DETAIL: What did your spearheading of " Evaluation Services " entail? What is Evaluation Services? What entity or entities are behind Evaluation Services? Did you participate materially in studies conducted on children and adolescents in South America? If so, what kind of studies? Were parental consent forms used? Or were these runaway children scooped up off the the streets of a big city? Which " psychotropic medicines " were employed? Paxil? Prozac? Zoloft? Sponsored by which pharmaceutical company(s)? GSK? Lilly? Pfizer? What was your relationship to pharmaceutical company(s) that provided the drugs? What quantity of drugs were given, in what doses, and for how long? Did you handle just the " numbers crunching " -- or did you also hand out drugs? What was the age range of participants? What was the age of the youngest child dosed? 8? 5? 2? Six months? Were any of these drugs given to pregnant teens? How many participants were used? Were there suicides, whether akathasia-induced or withdrawal-induced? What sort of safety monitoring was in place to safeguard the health of participants? What sort of documentation occurred? Where is that documentation today? Can you provide any sound reasoning as to why you should not immediately and publicly answer all of these questions? In closing: Dr. Katz's own remarks are that the " reinterpretation " of the SSRI pediatric data in question will be done so in an " objective " manner. Therefore I am calling for the immediate removal of Dr. Mann from the " Columbia group, " and for the immediate and full vetting of Dr. Posner-Gerstenhaber. Furthermore, I am calling on FDA to immediately release all names of persons selected by Dr. Katz and his colleagues who have been selected as members of " the Columbia group. " Dr. Temple (an FDA colleague of Katz) promised he would do this in a timely manner. More than one month has passed and Dr. Temple has not made good on his promise. I am also demanding FDA make available - immediately - for public inspection its Contract For Services with Columbia University relative to the Suicide Reclassification Project currently headed by Dr. Posner. If you have any questions regarding the (alleged) objective review of the SSRI-pediatric-suicide data slated to be performed by " the Columbia group, " (Dr. Posner, Dr. Mann, et al) and member's ties to pharmaceutical companies - they should be directed ASAP to key FDA personnel as follows: Dr. Temple at: robert.temple@... Dr. Katz at: russell.katz@... Dr. Laughren at: thomas.laughren@... ************************************************************** You're almost through. Click on the button that reads " Preview And Send Your Message " A new web page appears. In the lower left hand corner click the button " Send Your Message Electronically " You're done! One Minute Activism! Our message is on its way to Congress! Now that you've helped send our message to Congress I want to give you something as a way of saying " thanks. " Select one of the following bumper stickers: Paxil: Unsafe At Any Dose Zoloft: Unsafe At Any Dose Prozac: Unsafe At Any Dose Send an email to chv@... and let us know which one you want. Please be sure to include a name and mailing address so we'll know where to send it! Thanks for helping make a difference. Please copy this email to everyone in your address book whom you think will take one minute to help. In memory of " Kara " ... a child who committed suicide less than 24 hours after beginning a horrific " cold turkey " withdrawal from the SSRI antidepressant drug " Paxil. " _________________________________________________________________ Get business advice and resources to improve your work life, from bCentral. http://special.msn.com/bcentral/loudclear.armx Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 10, 2004 Report Share Posted March 10, 2004 Done! I also sent this forward to my parents and friends. Jim SSRI's, Children's Suicides and The FDA " Dear SSRI Citizen " Children of the United States need your help. TODAY Here's how you can help them. Right now. We promise this will only take about one minute of your time. Welcome ... to " One Minute Activism. " Its incredibly fast, easy, pain-free, costs nothing and best of all it works. How could it not with thousands of other people just like you who are doing the same thing right now! Think about it. Here's all you have to do. Are you ready? Let's go to a site called " Contacting The Congress " Click on this link: http://www.visi.com/juan/congress/cgi-bin/mailform2.cgi?site=ctc Fill in the form that appears. Type your first and last name, street address, city, state, zip. Now add your email address and phone number. When finished, click on the " button " beneath the " phone number " field. You'll be whisked to another web page. At the new web page that appears Click in the " Subject " field. Delete the " default " message: An Issue Of Concern To Me Paste (or type) the following text into the " Subject " box: SSRI's, Children's Suicides and The FDA Note: Pasted text will not appear in the " Subject " box until you click the " letter box " . Click in the " letter box " area below. Delete the default text that reads: I Am Contacting My Members Of Congress Now highlight, copy and paste the entire block of text provided below (between asterisked lines) into the same (letter box) field. ************************************************************** The Vetting of the FDA's SSRI Pediatric Columbia Group: Dr. Posner. Removal of Dr. Mann. View the entire FDA Meeting Transcript at: http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4006T1.htm " In our efforts to further evaluate the data, we have enlisted the help of outside experts with particular expertise in the issue of pediatric depression and suicide, and in particular, we have enlisted a group from Columbia University, who will objectively reclassify potential cases of suicidality from all the drug development programs, so that we may move forward with our more definitive analyses. You will hear about this from Dr. Posner in more detail later. " - Dr. Katz addressing the audience in opening remarks at the Monday, February 8th, 2004 FDA hearing regarding the use of SSRI's, suicidality and the pediatric population. Unless something dramatic occurs Dr. Posner will remain an integral part of the " Columbia group " referenced above in Dr. Katz's comments. Dr. Posner is responsible for coordinating the FDA's so called " Suicidality Classification Project. " By " dramatic " I mean to say: (if) disclosures of Dr. Posner's personal or family business interests reveal ties to the pharmaceutical company's whose drugs were the topic of discussion at this meeting. The public already knows this is the case with at least one member of the Columbia group whom Dr. Katz references: Dr. Mann. Just for starters, Dr. Mann testified on behalf of GlaxoKline (GSK) in what is known as " the Shell case. " In that case a jury - in a landmark decision - concluded ingestation of Paxil was the proximate cause of Mr. Shell's tragic actions ... whereby Mr. Shell shot to death members of his family before turning a gun on himself. Mr. Shell also died. GSK subsequently decided to appeal the verdict, but then on second thought decided not to. A transcript of this stunning trial as well as (shocking and disturbing) depositions of GSK personnel (including Wheadon) can be found at renowned SSRI expert Healy's web site: http://www.healyprozac.com While on the subject of Dr. Healy ... I implore you to read Dr. Healy's February 19th, 2004 letter to J. Pitts, Associate Commissioner For External Public Relations, FDA. At minimum, it should raise at least one of your eyebrows - about a mile high. A link to that letter can be found at: http://www.ahrp.org/risks/healy/FDA0204.html I also suggest reading the following letter from Tierney: http://www.baumhedlundlaw.com/media/ssri/paxil/FDAHearing/ TierneyLetter.htm But for the moment let's take a closer look at Dr. Posner. Just who is she? To begin with she actually goes by Dr. Posner-Gerstenhaber. Dr. Posner-Gerstenhaber graduated from Brown University with honors and went on to earn a Ph.D. in Clinical Psychology at Yeshiva University, after completing her doctoral research in pediatric oncology at the Memorial Sloan-Kettering Cancer Center. She then did an internship and fellowship at Babies' Hospital, Department of Child Psychiatry, Columbia-Presbyterian Medical Center. Dr. Posner-Gerstenhaber is a research scientist and the Director of Clinical Services of the Research Unit for Pediatric Psychopharmacology, at New York State Psychiatric Institute, Columbia University. In addition to her research responsibilities - which include running a number of pediatric clinical trials for industry and the NIMH - Dr. Gerstenhaber also teaches and directs a training program. QUESTIONS THAT MUST BE ADDRESSED BY DR. POSNER IMMEDIATELY AND IN DETAIL What pediatric trials? For which drug company(s)? What training program? For which drug company(s)? As part of an international research team (consisting of the neurology depts. of Harvard, Columbia, and others) Dr. Posner-Gerstenhaber traveled to Venezuela on multiple occasions. There she spear-headed the addition of something called " Evaluation Services, " and according to one source I have " made available greatly-needed psychotropic medications for (these) suffering children and adolescents. " MORE QUESTIONS THAT MUST BE ADDRESSED BY DR. POSNER IMMEDIATELY AND IN DETAIL: What did your spearheading of " Evaluation Services " entail? What is Evaluation Services? What entity or entities are behind Evaluation Services? Did you participate materially in studies conducted on children and adolescents in South America? If so, what kind of studies? Were parental consent forms used? Or were these runaway children scooped up off the the streets of a big city? Which " psychotropic medicines " were employed? Paxil? Prozac? Zoloft? Sponsored by which pharmaceutical company(s)? GSK? Lilly? Pfizer? What was your relationship to pharmaceutical company(s) that provided the drugs? What quantity of drugs were given, in what doses, and for how long? Did you handle just the " numbers crunching " -- or did you also hand out drugs? What was the age range of participants? What was the age of the youngest child dosed? 8? 5? 2? Six months? Were any of these drugs given to pregnant teens? How many participants were used? Were there suicides, whether akathasia-induced or withdrawal-induced? What sort of safety monitoring was in place to safeguard the health of participants? What sort of documentation occurred? Where is that documentation today? Can you provide any sound reasoning as to why you should not immediately and publicly answer all of these questions? In closing: Dr. Katz's own remarks are that the " reinterpretation " of the SSRI pediatric data in question will be done so in an " objective " manner. Therefore I am calling for the immediate removal of Dr. Mann from the " Columbia group, " and for the immediate and full vetting of Dr. Posner-Gerstenhaber. Furthermore, I am calling on FDA to immediately release all names of persons selected by Dr. Katz and his colleagues who have been selected as members of " the Columbia group. " Dr. Temple (an FDA colleague of Katz) promised he would do this in a timely manner. More than one month has passed and Dr. Temple has not made good on his promise. I am also demanding FDA make available - immediately - for public inspection its Contract For Services with Columbia University relative to the Suicide Reclassification Project currently headed by Dr. Posner. If you have any questions regarding the (alleged) objective review of the SSRI-pediatric-suicide data slated to be performed by " the Columbia group, " (Dr. Posner, Dr. Mann, et al) and member's ties to pharmaceutical companies - they should be directed ASAP to key FDA personnel as follows: Dr. Temple at: robert.temple@... Dr. Katz at: russell.katz@... Dr. Laughren at: thomas.laughren@... ************************************************************** You're almost through. Click on the button that reads " Preview And Send Your Message " A new web page appears. In the lower left hand corner click the button " Send Your Message Electronically " You're done! One Minute Activism! Our message is on its way to Congress! Now that you've helped send our message to Congress I want to give you something as a way of saying " thanks. " Select one of the following bumper stickers: Paxil: Unsafe At Any Dose Zoloft: Unsafe At Any Dose Prozac: Unsafe At Any Dose Send an email to chv@... and let us know which one you want. Please be sure to include a name and mailing address so we'll know where to send it! Thanks for helping make a difference. Please copy this email to everyone in your address book whom you think will take one minute to help. In memory of " Kara " ... a child who committed suicide less than 24 hours after beginning a horrific " cold turkey " withdrawal from the SSRI antidepressant drug " Paxil. " _________________________________________________________________ Get business advice and resources to improve your work life, from bCentral. http://special.msn.com/bcentral/loudclear.armx Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 10, 2004 Report Share Posted March 10, 2004 Done! I also sent this forward to my parents and friends. Jim SSRI's, Children's Suicides and The FDA " Dear SSRI Citizen " Children of the United States need your help. TODAY Here's how you can help them. Right now. We promise this will only take about one minute of your time. Welcome ... to " One Minute Activism. " Its incredibly fast, easy, pain-free, costs nothing and best of all it works. How could it not with thousands of other people just like you who are doing the same thing right now! Think about it. Here's all you have to do. Are you ready? Let's go to a site called " Contacting The Congress " Click on this link: http://www.visi.com/juan/congress/cgi-bin/mailform2.cgi?site=ctc Fill in the form that appears. Type your first and last name, street address, city, state, zip. Now add your email address and phone number. When finished, click on the " button " beneath the " phone number " field. You'll be whisked to another web page. At the new web page that appears Click in the " Subject " field. Delete the " default " message: An Issue Of Concern To Me Paste (or type) the following text into the " Subject " box: SSRI's, Children's Suicides and The FDA Note: Pasted text will not appear in the " Subject " box until you click the " letter box " . Click in the " letter box " area below. Delete the default text that reads: I Am Contacting My Members Of Congress Now highlight, copy and paste the entire block of text provided below (between asterisked lines) into the same (letter box) field. ************************************************************** The Vetting of the FDA's SSRI Pediatric Columbia Group: Dr. Posner. Removal of Dr. Mann. View the entire FDA Meeting Transcript at: http://www.fda.gov/ohrms/dockets/ac/04/transcripts/4006T1.htm " In our efforts to further evaluate the data, we have enlisted the help of outside experts with particular expertise in the issue of pediatric depression and suicide, and in particular, we have enlisted a group from Columbia University, who will objectively reclassify potential cases of suicidality from all the drug development programs, so that we may move forward with our more definitive analyses. You will hear about this from Dr. Posner in more detail later. " - Dr. Katz addressing the audience in opening remarks at the Monday, February 8th, 2004 FDA hearing regarding the use of SSRI's, suicidality and the pediatric population. Unless something dramatic occurs Dr. Posner will remain an integral part of the " Columbia group " referenced above in Dr. Katz's comments. Dr. Posner is responsible for coordinating the FDA's so called " Suicidality Classification Project. " By " dramatic " I mean to say: (if) disclosures of Dr. Posner's personal or family business interests reveal ties to the pharmaceutical company's whose drugs were the topic of discussion at this meeting. The public already knows this is the case with at least one member of the Columbia group whom Dr. Katz references: Dr. Mann. Just for starters, Dr. Mann testified on behalf of GlaxoKline (GSK) in what is known as " the Shell case. " In that case a jury - in a landmark decision - concluded ingestation of Paxil was the proximate cause of Mr. Shell's tragic actions ... whereby Mr. Shell shot to death members of his family before turning a gun on himself. Mr. Shell also died. GSK subsequently decided to appeal the verdict, but then on second thought decided not to. A transcript of this stunning trial as well as (shocking and disturbing) depositions of GSK personnel (including Wheadon) can be found at renowned SSRI expert Healy's web site: http://www.healyprozac.com While on the subject of Dr. Healy ... I implore you to read Dr. Healy's February 19th, 2004 letter to J. Pitts, Associate Commissioner For External Public Relations, FDA. At minimum, it should raise at least one of your eyebrows - about a mile high. A link to that letter can be found at: http://www.ahrp.org/risks/healy/FDA0204.html I also suggest reading the following letter from Tierney: http://www.baumhedlundlaw.com/media/ssri/paxil/FDAHearing/ TierneyLetter.htm But for the moment let's take a closer look at Dr. Posner. Just who is she? To begin with she actually goes by Dr. Posner-Gerstenhaber. Dr. Posner-Gerstenhaber graduated from Brown University with honors and went on to earn a Ph.D. in Clinical Psychology at Yeshiva University, after completing her doctoral research in pediatric oncology at the Memorial Sloan-Kettering Cancer Center. She then did an internship and fellowship at Babies' Hospital, Department of Child Psychiatry, Columbia-Presbyterian Medical Center. Dr. Posner-Gerstenhaber is a research scientist and the Director of Clinical Services of the Research Unit for Pediatric Psychopharmacology, at New York State Psychiatric Institute, Columbia University. In addition to her research responsibilities - which include running a number of pediatric clinical trials for industry and the NIMH - Dr. Gerstenhaber also teaches and directs a training program. QUESTIONS THAT MUST BE ADDRESSED BY DR. POSNER IMMEDIATELY AND IN DETAIL What pediatric trials? For which drug company(s)? What training program? For which drug company(s)? As part of an international research team (consisting of the neurology depts. of Harvard, Columbia, and others) Dr. Posner-Gerstenhaber traveled to Venezuela on multiple occasions. There she spear-headed the addition of something called " Evaluation Services, " and according to one source I have " made available greatly-needed psychotropic medications for (these) suffering children and adolescents. " MORE QUESTIONS THAT MUST BE ADDRESSED BY DR. POSNER IMMEDIATELY AND IN DETAIL: What did your spearheading of " Evaluation Services " entail? What is Evaluation Services? What entity or entities are behind Evaluation Services? Did you participate materially in studies conducted on children and adolescents in South America? If so, what kind of studies? Were parental consent forms used? Or were these runaway children scooped up off the the streets of a big city? Which " psychotropic medicines " were employed? Paxil? Prozac? Zoloft? Sponsored by which pharmaceutical company(s)? GSK? Lilly? Pfizer? What was your relationship to pharmaceutical company(s) that provided the drugs? What quantity of drugs were given, in what doses, and for how long? Did you handle just the " numbers crunching " -- or did you also hand out drugs? What was the age range of participants? What was the age of the youngest child dosed? 8? 5? 2? Six months? Were any of these drugs given to pregnant teens? How many participants were used? Were there suicides, whether akathasia-induced or withdrawal-induced? What sort of safety monitoring was in place to safeguard the health of participants? What sort of documentation occurred? Where is that documentation today? Can you provide any sound reasoning as to why you should not immediately and publicly answer all of these questions? In closing: Dr. Katz's own remarks are that the " reinterpretation " of the SSRI pediatric data in question will be done so in an " objective " manner. Therefore I am calling for the immediate removal of Dr. Mann from the " Columbia group, " and for the immediate and full vetting of Dr. Posner-Gerstenhaber. Furthermore, I am calling on FDA to immediately release all names of persons selected by Dr. Katz and his colleagues who have been selected as members of " the Columbia group. " Dr. Temple (an FDA colleague of Katz) promised he would do this in a timely manner. More than one month has passed and Dr. Temple has not made good on his promise. I am also demanding FDA make available - immediately - for public inspection its Contract For Services with Columbia University relative to the Suicide Reclassification Project currently headed by Dr. Posner. If you have any questions regarding the (alleged) objective review of the SSRI-pediatric-suicide data slated to be performed by " the Columbia group, " (Dr. Posner, Dr. Mann, et al) and member's ties to pharmaceutical companies - they should be directed ASAP to key FDA personnel as follows: Dr. Temple at: robert.temple@... Dr. Katz at: russell.katz@... Dr. Laughren at: thomas.laughren@... ************************************************************** You're almost through. Click on the button that reads " Preview And Send Your Message " A new web page appears. In the lower left hand corner click the button " Send Your Message Electronically " You're done! One Minute Activism! Our message is on its way to Congress! Now that you've helped send our message to Congress I want to give you something as a way of saying " thanks. " Select one of the following bumper stickers: Paxil: Unsafe At Any Dose Zoloft: Unsafe At Any Dose Prozac: Unsafe At Any Dose Send an email to chv@... and let us know which one you want. Please be sure to include a name and mailing address so we'll know where to send it! Thanks for helping make a difference. Please copy this email to everyone in your address book whom you think will take one minute to help. In memory of " Kara " ... a child who committed suicide less than 24 hours after beginning a horrific " cold turkey " withdrawal from the SSRI antidepressant drug " Paxil. " _________________________________________________________________ Get business advice and resources to improve your work life, from bCentral. http://special.msn.com/bcentral/loudclear.armx Quote Link to comment Share on other sites More sharing options...
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