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!!!"
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!!!"
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.