What are the repercussions for breaking a law such as this other than a slap of the wrist and a turn of the head. Unfortunately it is more of a slap in our face to wake us up and not follow blindly the rhetoric that the drug companies keep spewing out.
Do we know how Zoetis responded to this letter? Did they make any changes to their promo material, or clarify their trials? I can’t find anything, but am inclined to make a FOIA request.
If you want to know their playbook, this was written by a doctor who served as an expert witness in drug litigation lawsuits. It will make you sick to your stomach.
If you have the time please do it. I dont think they changed a thing. Even after multimillion dollar lawsuits they dont change anything. They buy their way out in settlement money if all of the data is buried.
Thank you Dr Josie for being the exemplary veterinarian who chooses to practice medicine the safe and effective way. This review took an incredible amount of time and research - all in the name of protecting the animals whom are lucky enough to cross your path. The number of medicines that fail in the human world and make their way to the veterinary practice is mind boggling. It is my hope that the veterinarians who are recommending this for patients who come through their office will read this (publish it in an AVMA journal?) and at the very least, have a long talk with the pet owner about safer alternatives (including changing the dogs diet!) The origin of the word doctor came from the Latin word “to teach”. Somewhere along the line it seems to have become “to prescribe”. Thankful for your knowledge and your teachings.
My 13.5 yrs dog was on Librela for four months and two weeks ago was diagnosed with a severe arrhythmia (400bpm) and weak left ventricle (he had previously had a very intermittent arrhythmia). We were faced with pts or treatments with lidocaine to try to get back into regular sinus rhythm. Treatment worked (though there is still a slight arrhythmia) and he is currently on Vetmedin and Sotalol. At the time I did wonder if Librela might have caused the issue but searching found no link between it and heart issues, until today and reading here about NGF. But I have to question with ‘new’ conditions in an elderly dog is it just age related or has it been caused by a drug? There is no way of knowing.
The dilemma I face now is whether to continue with Librela knowing it keeps him comfortable and risk potential further heart deterioration and shortened life or take him off Librela and potentially give him longer but in discomfort with his arthritis………
having had the arrhythmia, i would not risk it unless you are willing to accept the risk of death. I hate to put it so bluntly but you have to go to that place.
Nerve growth factor is found in cardiac tissue, and, asit states in the package insert, they have no idea what lkind of effect Librela has on the heart.
I decided not to continue. I am in the UK and the package insert there does not have the same wording as the US one. There is no mention of the connect between NGF and the heart like there is on the US one. If there had been I would not have used it in the first place.
Thank you for this excellent article. In my holistic practice, I have seen both animals helped by Librela and animals with horrible negative reactions, especially in their kidneys. I would be EXTREMELY careful in using Librela.
Thanks for your work on this Josie. I'll be sharing it with my readers on Sunday in my newsletter, adding some of my own perspective. Like you, this is a No Way drug for anyone who asks me about it. Way too many red flags.
I have already spoken to 3 different clients this week whose dogs have had reactions. Its pretty scary. One of the biggest problems is that many clinics are reaching for it as an easy once a month injection for any kind of pain. Thanks for sharing.
If you've a mind, gabapentin could be next on your "uncovering the dirt" work on drugs. Latest from Vet Practice News: https://www.veterinarypracticenews.com/nc-law-gabapentin/ It's about to become a reportable drug, even though not scheduled, due to human abuse. I can't imagine it's helping animals with its history…
Leider schlecht recherchiert und Äpfel mit Birnen verglichen.
Welchen Einfluss ein monoklonaler Antikörper hat, ist vom Ziel und vom Aufbau abhängig. Richtet er sich z.B. gegen Igs oder TNF und handelt es sich um einen mAk mit Fremdmaterial, ist das Risiko einer Immunantwort hoch. Librela ist jedoch ein rein caniner mAk und richtet sich gegen NGF, nicht gegen TNF oder Ig.
Tuberkulose ist hier irrelevant. Diese Info bezieht sich auf immunhemmende mAks
Auch die Informationen über Tanezumab sind unvollständig und nicht vergleichbar, da hier humanisierte mAk eingesetzt wurden. Also keine reinen humanen mAk. Zudem traten Nebenwirkungen verstärkt bei Überdosierung auf.
Hier sind noch etliche andere Fehler.
Richtig ist, dass die Studien nicht sehr aussagekräftig sind. Das ist aber bei allen Studien so. Man schaue sich z.B. die (überwiegend nicht vorhandenen) Studien zu Galliprant an.
I do not us Galliprant either. And yes, studies are limited but pet parents need to know that with new products, they are essentially enetering their animals into Phase III clinical trials. I prefer to wait and see what the effects are before I administer it to my [atients.
We do not even fully understand the effects NGF has in the body, so top bind it and block it, we may run into adverse effects.
Further clarification of the "untitled letter" sent by the FDA to Zoetis that I have linked above and here:
https://www.fda.gov/media/174818/download?attachment
"This is the FDA saying... Zoetis BROKE U.S. FEDERAL LAW BY MISLEADING CONSUMERS ABOUT THE EFFICACY OF THEIR PRODUCT on their website!!!"
What are the repercussions for breaking a law such as this other than a slap of the wrist and a turn of the head. Unfortunately it is more of a slap in our face to wake us up and not follow blindly the rhetoric that the drug companies keep spewing out.
Exactly! the FDA, EPA , CDC are operating under full agrncy capture by the corporations and pharma.
Do we know how Zoetis responded to this letter? Did they make any changes to their promo material, or clarify their trials? I can’t find anything, but am inclined to make a FOIA request.
If you want to know their playbook, this was written by a doctor who served as an expert witness in drug litigation lawsuits. It will make you sick to your stomach.
https://a.co/d/bb5PpTW
Sickening: How Big Pharma Broke American Health Care and How We Can Repair It
If you have the time please do it. I dont think they changed a thing. Even after multimillion dollar lawsuits they dont change anything. They buy their way out in settlement money if all of the data is buried.
Thank you Dr Josie for being the exemplary veterinarian who chooses to practice medicine the safe and effective way. This review took an incredible amount of time and research - all in the name of protecting the animals whom are lucky enough to cross your path. The number of medicines that fail in the human world and make their way to the veterinary practice is mind boggling. It is my hope that the veterinarians who are recommending this for patients who come through their office will read this (publish it in an AVMA journal?) and at the very least, have a long talk with the pet owner about safer alternatives (including changing the dogs diet!) The origin of the word doctor came from the Latin word “to teach”. Somewhere along the line it seems to have become “to prescribe”. Thankful for your knowledge and your teachings.
Could not agree more❣️🙏
Thank you Becky! I was unaware of the origin of "doctor". Its interesting. Thanks for the comment. Sometimes I feel like i am in an echo chamber, lol
My 13.5 yrs dog was on Librela for four months and two weeks ago was diagnosed with a severe arrhythmia (400bpm) and weak left ventricle (he had previously had a very intermittent arrhythmia). We were faced with pts or treatments with lidocaine to try to get back into regular sinus rhythm. Treatment worked (though there is still a slight arrhythmia) and he is currently on Vetmedin and Sotalol. At the time I did wonder if Librela might have caused the issue but searching found no link between it and heart issues, until today and reading here about NGF. But I have to question with ‘new’ conditions in an elderly dog is it just age related or has it been caused by a drug? There is no way of knowing.
The dilemma I face now is whether to continue with Librela knowing it keeps him comfortable and risk potential further heart deterioration and shortened life or take him off Librela and potentially give him longer but in discomfort with his arthritis………
having had the arrhythmia, i would not risk it unless you are willing to accept the risk of death. I hate to put it so bluntly but you have to go to that place.
Nerve growth factor is found in cardiac tissue, and, asit states in the package insert, they have no idea what lkind of effect Librela has on the heart.
I decided not to continue. I am in the UK and the package insert there does not have the same wording as the US one. There is no mention of the connect between NGF and the heart like there is on the US one. If there had been I would not have used it in the first place.
Thank you for this excellent article. In my holistic practice, I have seen both animals helped by Librela and animals with horrible negative reactions, especially in their kidneys. I would be EXTREMELY careful in using Librela.
Thanks for your work on this Josie. I'll be sharing it with my readers on Sunday in my newsletter, adding some of my own perspective. Like you, this is a No Way drug for anyone who asks me about it. Way too many red flags.
I have already spoken to 3 different clients this week whose dogs have had reactions. Its pretty scary. One of the biggest problems is that many clinics are reaching for it as an easy once a month injection for any kind of pain. Thanks for sharing.
Thank you Dr Josie Beung. I would to share my dogs story/decline you and the medical records. I think you might find them very interesting.
If you've a mind, gabapentin could be next on your "uncovering the dirt" work on drugs. Latest from Vet Practice News: https://www.veterinarypracticenews.com/nc-law-gabapentin/ It's about to become a reportable drug, even though not scheduled, due to human abuse. I can't imagine it's helping animals with its history…
i wrote an article for Dogs Naturally Magazine a couple years ago following the money on that one.
Leider schlecht recherchiert und Äpfel mit Birnen verglichen.
Welchen Einfluss ein monoklonaler Antikörper hat, ist vom Ziel und vom Aufbau abhängig. Richtet er sich z.B. gegen Igs oder TNF und handelt es sich um einen mAk mit Fremdmaterial, ist das Risiko einer Immunantwort hoch. Librela ist jedoch ein rein caniner mAk und richtet sich gegen NGF, nicht gegen TNF oder Ig.
Tuberkulose ist hier irrelevant. Diese Info bezieht sich auf immunhemmende mAks
https://pubmed.ncbi.nlm.nih.gov/30677828/
Auch die Informationen über Tanezumab sind unvollständig und nicht vergleichbar, da hier humanisierte mAk eingesetzt wurden. Also keine reinen humanen mAk. Zudem traten Nebenwirkungen verstärkt bei Überdosierung auf.
Hier sind noch etliche andere Fehler.
Richtig ist, dass die Studien nicht sehr aussagekräftig sind. Das ist aber bei allen Studien so. Man schaue sich z.B. die (überwiegend nicht vorhandenen) Studien zu Galliprant an.
I do not us Galliprant either. And yes, studies are limited but pet parents need to know that with new products, they are essentially enetering their animals into Phase III clinical trials. I prefer to wait and see what the effects are before I administer it to my [atients.
We do not even fully understand the effects NGF has in the body, so top bind it and block it, we may run into adverse effects.