Wow! I had no idea of these documents and I was a FDA reviewer (clinical pharmacology) of Psych drugs for 7 years.
You're correct in your next to last paragraph that it's a systemic issue and not just related to one drug or class of drugs. I know I worked on Vioxx, antidepressants, and GI drugs under development at Merck. Plus at the FDA I worked in 5 different divisions and reviewed drugs for diabetes, osteoporosis, GI disorders (including Lotronex - we knew it was unsafe prior to approval), hematology, hormone replacement, urology, neurology, and psychiatry.
As Tom Laughren the FDA Psych Division Director was over heard saying to a medical reviewer (actually yelled at) who recommended not approving an antipsychotic because of a lack of evidence it worked. "OUR JOB IS TO APPROVE DRUGS!!!"
Thanks for your important insider perspective. I can only imagine the pressure inside the FDA to approve the drugs coming from top down. In 2006 Union of Concerned Scientist did a survey of FDA employees that was fascinating too. It might be time to do another one.
As far as the internal documents, it is not surprising that you didn't see them because some were buried deep in Pfizer files. I have an entire binder worth of documents that as a reviewer you would be interested in. Many talking about the efficacy of Zoloft as well as suicidality signal.
When I saw these Pfizer and FDA documents with my own eyes on their letterhead, I knew that I needed to share them widely. I was lucky that my attorneys at Baum Hedlund worked tirelessly to get them declassified so that they could be shared publicly. Now it was no longer me telling Woody's "anecdotal" story but it was something that the FDA/Pfizer knew. It's why we need to have lawsuits. Wait until I write about what FDA Chief Counsel Dan Troy did to intervene with Pfizer Zoloft lawsuits...He came from industry to FDA, then left the FDA to ultimately become Global Counsel for Glaxo Smith Kline.
Yes the pressure was intense. I had my children threatened. I was called a saboteur, slides where shown in a meeting that implied I would be killed and I was used as an example to others of what would happen to them if they didn't help Pharma. I was accused of being dangerous and making threats of violence for reporting crimes including to Congress and criminal investigators in OIG and the FBI and for exercising my First Amendment rights to report crimes that threatened my own life. Where as a consequence of these false claims of threats I was afraid that security might be called and I could be shot and killed. Ultimately, I lost my career. Baum Hedlund also took me on as a client. No one else would because as a govt employee I needed DOJ 's help and as I was told, the FDA is DOJ's client.
I can't tell you the number of members of Congress I've gone to. Unfortunately, as Allan Jones was told, "they (Pharma) write checks to both sides of the aisle."
There you have it, folks. People ion Western society believe that if A will kill them & their children, but politicians say they have to inject them with A anyway, that they simply must do so & that there is no legal way to stop getting themselves OR their children injected with A.
“Because Mommy-Government told us we have to.”
They actually think that there are laws in place that say anywhere in their constitution that their politicians can mandate anything let alone untested products, & should they do so, then the citizens have zero choice but to comply with these decisions: that there are zero legal avenues against such tyranny in Free & democratic nations. & that this is written into their constitution.
They actually think that there are legalities forcing them to comply with decisions made by politicians/that this tyranny is legal.
What utter cowards you all are that you’d rather risk the health & well-being of everyone you’ve ever cared about than stand up for them against what? One Constipated-looking Scowl of Discontent From Mitch Pelosi? Or Nancy McConnell?
Your own children mean less to you than the Imaginary Love & Acceptance of these Complete Strangers who will never even know you exist?
Then take the damned jab already. If the threat of being though of as a square by the Cool Kids In Congress is too much for your emotional infancy to bear so that you actively refuse to hold them accountable for MURDERING YOUR LOVED ONES, then TAKE the damned jab. Because they will NEVER remove themselves from sitting in those seats of power that you love more than your own children.
Impressive work, my friend. But this is an even more impressive display of love for Woody and a dedication to helping humanity. These efforts clearly show a lifetime of love for Woody and for others.
They bring about a question that should be heard worldwide. Why are these medications allowed to hide the truth from the people that seek help?
As a young widow, you asked these questions, and they were answered by your dedication and tireless quest to protect others so that they did not know the pain you knew. As a result of your work, once alerted by you and these efforts, the public would not accept the drug companies hiding this truth. Your media campaign is beyond impressive.
Sadly, more work is needed; a thousand "Kims" are needed to expose and reign in the rampant drug safety failures within the drug industry. And thousands "Kims" are required in order to successfully "march upon the steps" of the lawmaker's "doors" (whether that is online or via media campaigns or in hearings); it is evident a loud and convincing demand for change is called for. It is also evident that new rules for monitoring drug safety are necessary.
Clearly, without significant action, our future of medicine and prescription drugs is likely dominated by this sneaky advertising you describe and the act of withholding all the facts from the public.
We have all experienced it, and we all know it, but many do not realize their rights and power. The drug companies allowed these harms once; they have done it again, and now countless millions of times. Yet, they expect weakness in us after harming our families and us repeatedly. That is abuse, and it must be stood up to.
I know that the people have power, and they speak and have spoken online about these repeated actions by big pharma, seen throughout countless prescription medications and vaccines.
It is time to unite and realize this power so that we may take back our rights to be informed and warned as the laws intended, and if the needed laws are missing, well, that task is also at hand. If you are capable of accomplishing the above, then you can do anything, then I (and every wronged mama bear) can do anything with your teaching. I, for one, am here to assist in bringing an army of mama bears and papa bears to the movement.
Enough is enough. Woody matters. Cody matters. Junior matters. Sean Matters. Trista matters. Adam matters. Human lives matter; they are not simply a drug company commodity.
Your prayer has been answered, Kim, in such a powerful way. Thank you for using your fierce love and deep pain to make a profound difference in other people's lives and to expose these unconscionable "business practices" from drug companies and regulators. What their corrupt calculations fail to reckon is the power of love that cannot be overcome.
Thank you to everyone in this fight. I'm so sorry for the grief that makes this work so very personal for so many people. May God bind up our broken hearts and give us strength to stand together. It is very much a David and Goliath battle, but we know how that one turned out.
You are to be commended for your tireless efforts on behalf of your fellow citizens, in honor of your beloved Woody. Thank you for your acts of courage and service.
Wow! I had no idea of these documents and I was a FDA reviewer (clinical pharmacology) of Psych drugs for 7 years.
You're correct in your next to last paragraph that it's a systemic issue and not just related to one drug or class of drugs. I know I worked on Vioxx, antidepressants, and GI drugs under development at Merck. Plus at the FDA I worked in 5 different divisions and reviewed drugs for diabetes, osteoporosis, GI disorders (including Lotronex - we knew it was unsafe prior to approval), hematology, hormone replacement, urology, neurology, and psychiatry.
As Tom Laughren the FDA Psych Division Director was over heard saying to a medical reviewer (actually yelled at) who recommended not approving an antipsychotic because of a lack of evidence it worked. "OUR JOB IS TO APPROVE DRUGS!!!"
Thanks for your important insider perspective. I can only imagine the pressure inside the FDA to approve the drugs coming from top down. In 2006 Union of Concerned Scientist did a survey of FDA employees that was fascinating too. It might be time to do another one.
https://scienceblogs.com/grrlscientist/2006/07/20/fda-scientists-pressure-to-exc
As far as the internal documents, it is not surprising that you didn't see them because some were buried deep in Pfizer files. I have an entire binder worth of documents that as a reviewer you would be interested in. Many talking about the efficacy of Zoloft as well as suicidality signal.
When I saw these Pfizer and FDA documents with my own eyes on their letterhead, I knew that I needed to share them widely. I was lucky that my attorneys at Baum Hedlund worked tirelessly to get them declassified so that they could be shared publicly. Now it was no longer me telling Woody's "anecdotal" story but it was something that the FDA/Pfizer knew. It's why we need to have lawsuits. Wait until I write about what FDA Chief Counsel Dan Troy did to intervene with Pfizer Zoloft lawsuits...He came from industry to FDA, then left the FDA to ultimately become Global Counsel for Glaxo Smith Kline.
A sociopath only interested in money and power? An all too familiar story I’m afraid!
Yes the pressure was intense. I had my children threatened. I was called a saboteur, slides where shown in a meeting that implied I would be killed and I was used as an example to others of what would happen to them if they didn't help Pharma. I was accused of being dangerous and making threats of violence for reporting crimes including to Congress and criminal investigators in OIG and the FBI and for exercising my First Amendment rights to report crimes that threatened my own life. Where as a consequence of these false claims of threats I was afraid that security might be called and I could be shot and killed. Ultimately, I lost my career. Baum Hedlund also took me on as a client. No one else would because as a govt employee I needed DOJ 's help and as I was told, the FDA is DOJ's client.
I can't tell you the number of members of Congress I've gone to. Unfortunately, as Allan Jones was told, "they (Pharma) write checks to both sides of the aisle."
I hope one day that things will come out.
There you have it, folks. People ion Western society believe that if A will kill them & their children, but politicians say they have to inject them with A anyway, that they simply must do so & that there is no legal way to stop getting themselves OR their children injected with A.
“Because Mommy-Government told us we have to.”
They actually think that there are laws in place that say anywhere in their constitution that their politicians can mandate anything let alone untested products, & should they do so, then the citizens have zero choice but to comply with these decisions: that there are zero legal avenues against such tyranny in Free & democratic nations. & that this is written into their constitution.
They actually think that there are legalities forcing them to comply with decisions made by politicians/that this tyranny is legal.
What utter cowards you all are that you’d rather risk the health & well-being of everyone you’ve ever cared about than stand up for them against what? One Constipated-looking Scowl of Discontent From Mitch Pelosi? Or Nancy McConnell?
Your own children mean less to you than the Imaginary Love & Acceptance of these Complete Strangers who will never even know you exist?
Then take the damned jab already. If the threat of being though of as a square by the Cool Kids In Congress is too much for your emotional infancy to bear so that you actively refuse to hold them accountable for MURDERING YOUR LOVED ONES, then TAKE the damned jab. Because they will NEVER remove themselves from sitting in those seats of power that you love more than your own children.
Sounds like a psycho! 😀
Kim,
Impressive work, my friend. But this is an even more impressive display of love for Woody and a dedication to helping humanity. These efforts clearly show a lifetime of love for Woody and for others.
They bring about a question that should be heard worldwide. Why are these medications allowed to hide the truth from the people that seek help?
As a young widow, you asked these questions, and they were answered by your dedication and tireless quest to protect others so that they did not know the pain you knew. As a result of your work, once alerted by you and these efforts, the public would not accept the drug companies hiding this truth. Your media campaign is beyond impressive.
Sadly, more work is needed; a thousand "Kims" are needed to expose and reign in the rampant drug safety failures within the drug industry. And thousands "Kims" are required in order to successfully "march upon the steps" of the lawmaker's "doors" (whether that is online or via media campaigns or in hearings); it is evident a loud and convincing demand for change is called for. It is also evident that new rules for monitoring drug safety are necessary.
Clearly, without significant action, our future of medicine and prescription drugs is likely dominated by this sneaky advertising you describe and the act of withholding all the facts from the public.
We have all experienced it, and we all know it, but many do not realize their rights and power. The drug companies allowed these harms once; they have done it again, and now countless millions of times. Yet, they expect weakness in us after harming our families and us repeatedly. That is abuse, and it must be stood up to.
I know that the people have power, and they speak and have spoken online about these repeated actions by big pharma, seen throughout countless prescription medications and vaccines.
It is time to unite and realize this power so that we may take back our rights to be informed and warned as the laws intended, and if the needed laws are missing, well, that task is also at hand. If you are capable of accomplishing the above, then you can do anything, then I (and every wronged mama bear) can do anything with your teaching. I, for one, am here to assist in bringing an army of mama bears and papa bears to the movement.
Enough is enough. Woody matters. Cody matters. Junior matters. Sean Matters. Trista matters. Adam matters. Human lives matter; they are not simply a drug company commodity.
Your prayer has been answered, Kim, in such a powerful way. Thank you for using your fierce love and deep pain to make a profound difference in other people's lives and to expose these unconscionable "business practices" from drug companies and regulators. What their corrupt calculations fail to reckon is the power of love that cannot be overcome.
Thank you to everyone in this fight. I'm so sorry for the grief that makes this work so very personal for so many people. May God bind up our broken hearts and give us strength to stand together. It is very much a David and Goliath battle, but we know how that one turned out.
You are to be commended for your tireless efforts on behalf of your fellow citizens, in honor of your beloved Woody. Thank you for your acts of courage and service.
This is unbearably sad. I am so sorry for your loss.