Did you know harm from prescribed medication is the 4th leading cause of death? (Some even say it’s the 3rd leading cause behind cancer and heart disease.) Regardless, it shouldn’t be this way. 959 deaths a day, over 350k every year. That’s like five 737 planes full of people falling out of the sky, every day.
dear Kim, with greetings from Holland, the Netherlands. Read the kind of lying of effectiveniss and safetey of Zoloft or Sertraline. THERE IS NO EFFECTIVENISS OR SAFETY OF ZOLOFT FOR PTSD BY MEN AND VETERANS. The 4 th study was with patients of a VA Hospital and there was NO EFFECT of ZOLOFT in VETERANS. This study was never done again by PFIZER !!!
October 8, 1999: Zoloft for Posttraumatic Stress Disorder (PTSD)
Questions for the Psychopharmacological Drugs Advisory Committee
The topic for this meeting is an application for Zoloft in the treatment of Posttraumatic Stress Disorder (PTSD). As you are aware, there are as yet no drugs approved for this indication in the US. Since there are no regulatory precedents in this area, we will take more time than we ordinarily would with an established indication to identify some general issues pertinent to developing drugs for this indication. In addition, there are specific issues pertinent to this application. Finally, we will ask you to vote on the usual questions regarding the efficacy and safety of Zoloft for PTSD.
1. GENERAL QUESTIONS/ISSUES REGARDING PTSD AS A NEW INDICATION:
1. Although PTSD is discussed in DSM-IV and diagnostic criteria are provided, it is still reasonable to ask how widely recognized and accepted this entity is, and how well-defined it is as an independent clinical entity. Given that the clinical features of PTSD include a number of findings that are also common to various depressive disorders, and major depressive disorder (MDD) is a common comorbid diagnosis with PTSD, can PTSD be considered independent of depressive subtypes, in particular, MDD?
1. Since we have had no experience reviewing applications for this indication, we would like your general advice regarding the development of drug products in this area.
1. What is the optimal approach for recruiting patients for drug studies of PTSD?
1. Are DSM-IV criteria the most appropriate criteria to use in selecting patients for trials?
1. What other inclusion criteria are appropriate?
1. What exclusion criteria are appropriate?
1. What is the optimal study design for drug studies of PTSD?
1. Should these trials be parallel group or is a crossover design acceptable?
1. How long should the short-term trials be?
1. How important is it to understand the dose/response relationship for efficacy, and as a consequence, should these be fixed dose or dose titration studies?
1. What assessment instruments are useful for assessing change in patients with PTSD? How valid and reliable are the recommended instruments?
1. What is an optimal primary outcome (or outcomes) for PTSD trials?
1. Given that PTSD is a chronic condition, should longer-term efficacy data be included in a development program?
1. When should such information be provided, in relation to an approval decision?
1. What trial designs would be optimal for addressing this question?
1. Is PTSD found in pediatric populations and should sponsor’s of drug products for this condition be encouraged to study this disorder in pediatric patients?
1. Are there specific safety questions that need to be addressed in development programs for this indication?
1. SPECIFIC QUESTIONS/ISSUES REGARDING THE NDA FOR ZOLOFT IN THE TREATMENT OF PTSD:
1. Did the clinical trials, provided in support of Zoloft in the treatment of PTSD, succeed in demonstrating an effect specific to PTSD (and independent of Zoloft’s antidepressant effect)?
1. Is this an important question and would a failure to clearly demonstrate an independent PTSD effect influence the decision about the approvability of this application?
1. Although the Division has not yet reached a final judgement on how to interpret the results of the efficacy data submitted in support of Zoloft in the treatment of PTSD, the primary reviewers have concluded that 2 of the 4 studies have succeeded overall in showing an effect of Zoloft on the identified primary outcomes. However, there is a gender interaction in both studies, revealing that the overall positive effects are derived entirely from the women with PTSD, with no effects observed in the men in these trials.
1. Is there an explanation for this finding?
1. Is this finding consistent with other trials with this disorder?
1. Should this finding influence the decision about the approvability of this application?
1. Although 2 of the 4 studies have succeeded overall in showing an effect of Zoloft on the identified primary outcomes, the other 2 studies were not able to show an effect of Zoloft on the identified primary outcomes.
1. Is there an explanation for this finding?
1. Should this finding influence the decision about the approvability of this application?
1. A relatively small number of patients participated in the 4 trials submitted in support of a new indication for Zoloft in the treatment of PTSD. Thus, a judgement about the safety of Zoloft in the PTSD population requires a reliance on the safety experience with other populations exposed to this drug. Is this a reasonable extrapolation?
1. OTHER QUESTIONS/ISSUES:
This is not by any means an exhaustive list of questions and issues that may benefit from discussion at the October 8th meeting, and we hope you will bring up and discuss any other questions or issues that you feel are pertinent to this specific application or more generally to the development of drug products for this new indication. A meeting of the PDAC on an application for an indication for which there are no previous approvals takes on added importance since, in a sense, it sets precedents for future development programs and applications for that indication.
1. ment of PTSD?QUESTIONS REQUIRING A VOTE OF THE PDAC:
1. Has the sponsor provided evidence from more than one adequate and well controlled clinical investigation that supports the conclusion that Zoloft is effective for the treatment of posttraumatic stress disorder (PTSD)?
1. Has the sponsor provided evidence that Zoloft is safe when used in the treatment of PTSD ?
Thank you for compassionately championing this cause. Consumers deserve to know the benefits and the risks of any medication. Doctors need to be trained on both as well. I am hoping that Americans are waking up to the risks the FDA is willing to allow be prescribed to them every year and are brave enough to take a stand.
Thank you Kim. This Awareness, Caution and Accountability will help save many lives. We 🇺🇸 deserve better, we 🇺🇸 must demand better.
Oh I believe its definitely still #3 and that the numbers within that category are not accurate and in reality are much higher.
Thank you for your leadership, friendship, support and bravery in demanding safer pharmaceuticals for all. You are Team Humanity. 💜
Thanks for your work trying to reform the FDA Kim.
That is the second time today that I have seen a link to the 2014 paper by your friend and my distant cousin Peter Gøtzsche!
I list some Deaths from selected drugs here:
https://geoffpain.substack.com/p/deaths-and-birth-defects-from-the
Can you share the link to watch the film please?
dear Kim, with greetings from Holland, the Netherlands. Read the kind of lying of effectiveniss and safetey of Zoloft or Sertraline. THERE IS NO EFFECTIVENISS OR SAFETY OF ZOLOFT FOR PTSD BY MEN AND VETERANS. The 4 th study was with patients of a VA Hospital and there was NO EFFECT of ZOLOFT in VETERANS. This study was never done again by PFIZER !!!
-------------------------------------------------------------------------------------------------------------
FDA
October 8, 1999: Zoloft for Posttraumatic Stress Disorder (PTSD)
Questions for the Psychopharmacological Drugs Advisory Committee
The topic for this meeting is an application for Zoloft in the treatment of Posttraumatic Stress Disorder (PTSD). As you are aware, there are as yet no drugs approved for this indication in the US. Since there are no regulatory precedents in this area, we will take more time than we ordinarily would with an established indication to identify some general issues pertinent to developing drugs for this indication. In addition, there are specific issues pertinent to this application. Finally, we will ask you to vote on the usual questions regarding the efficacy and safety of Zoloft for PTSD.
1. GENERAL QUESTIONS/ISSUES REGARDING PTSD AS A NEW INDICATION:
1. Although PTSD is discussed in DSM-IV and diagnostic criteria are provided, it is still reasonable to ask how widely recognized and accepted this entity is, and how well-defined it is as an independent clinical entity. Given that the clinical features of PTSD include a number of findings that are also common to various depressive disorders, and major depressive disorder (MDD) is a common comorbid diagnosis with PTSD, can PTSD be considered independent of depressive subtypes, in particular, MDD?
1. Since we have had no experience reviewing applications for this indication, we would like your general advice regarding the development of drug products in this area.
1. What is the optimal approach for recruiting patients for drug studies of PTSD?
1. Are DSM-IV criteria the most appropriate criteria to use in selecting patients for trials?
1. What other inclusion criteria are appropriate?
1. What exclusion criteria are appropriate?
1. What is the optimal study design for drug studies of PTSD?
1. Should these trials be parallel group or is a crossover design acceptable?
1. How long should the short-term trials be?
1. How important is it to understand the dose/response relationship for efficacy, and as a consequence, should these be fixed dose or dose titration studies?
1. What assessment instruments are useful for assessing change in patients with PTSD? How valid and reliable are the recommended instruments?
1. What is an optimal primary outcome (or outcomes) for PTSD trials?
1. Given that PTSD is a chronic condition, should longer-term efficacy data be included in a development program?
1. When should such information be provided, in relation to an approval decision?
1. What trial designs would be optimal for addressing this question?
1. Is PTSD found in pediatric populations and should sponsor’s of drug products for this condition be encouraged to study this disorder in pediatric patients?
1. Are there specific safety questions that need to be addressed in development programs for this indication?
1. SPECIFIC QUESTIONS/ISSUES REGARDING THE NDA FOR ZOLOFT IN THE TREATMENT OF PTSD:
1. Did the clinical trials, provided in support of Zoloft in the treatment of PTSD, succeed in demonstrating an effect specific to PTSD (and independent of Zoloft’s antidepressant effect)?
1. Is this an important question and would a failure to clearly demonstrate an independent PTSD effect influence the decision about the approvability of this application?
1. Although the Division has not yet reached a final judgement on how to interpret the results of the efficacy data submitted in support of Zoloft in the treatment of PTSD, the primary reviewers have concluded that 2 of the 4 studies have succeeded overall in showing an effect of Zoloft on the identified primary outcomes. However, there is a gender interaction in both studies, revealing that the overall positive effects are derived entirely from the women with PTSD, with no effects observed in the men in these trials.
1. Is there an explanation for this finding?
1. Is this finding consistent with other trials with this disorder?
1. Should this finding influence the decision about the approvability of this application?
1. Although 2 of the 4 studies have succeeded overall in showing an effect of Zoloft on the identified primary outcomes, the other 2 studies were not able to show an effect of Zoloft on the identified primary outcomes.
1. Is there an explanation for this finding?
1. Should this finding influence the decision about the approvability of this application?
1. A relatively small number of patients participated in the 4 trials submitted in support of a new indication for Zoloft in the treatment of PTSD. Thus, a judgement about the safety of Zoloft in the PTSD population requires a reliance on the safety experience with other populations exposed to this drug. Is this a reasonable extrapolation?
1. OTHER QUESTIONS/ISSUES:
This is not by any means an exhaustive list of questions and issues that may benefit from discussion at the October 8th meeting, and we hope you will bring up and discuss any other questions or issues that you feel are pertinent to this specific application or more generally to the development of drug products for this new indication. A meeting of the PDAC on an application for an indication for which there are no previous approvals takes on added importance since, in a sense, it sets precedents for future development programs and applications for that indication.
1. ment of PTSD?QUESTIONS REQUIRING A VOTE OF THE PDAC:
1. Has the sponsor provided evidence from more than one adequate and well controlled clinical investigation that supports the conclusion that Zoloft is effective for the treatment of posttraumatic stress disorder (PTSD)?
1. Has the sponsor provided evidence that Zoloft is safe when used in the treatment of PTSD ?
Thank you for compassionately championing this cause. Consumers deserve to know the benefits and the risks of any medication. Doctors need to be trained on both as well. I am hoping that Americans are waking up to the risks the FDA is willing to allow be prescribed to them every year and are brave enough to take a stand.