Welcome to our report on an unseen, yet crucial study regarding the popular wrinkle and therapeutic treatment, Botox. Today, we uncover the dark side of its testing process on animals, specifically monkeys.
A study from 1994, kept in our files and previously reported by Channel 4 news Oklahoma, reveals the cruel testing of botulinum neurotoxin type A, a.k.a.
Botox, conducted by Allergan.
This study aimed to assess the chronic toxicity of intramuscular Botox. The study involved administering Botox to Cynomolgus monkeys in doses of 4, 8, and 16 units per kilogram over the course of one year.
The goal was to evaluate the reversibility of any effects during a post-dose recovery period.
Conducted at Pharmaco LSR Incorporated, the monkeys were subjected to botulinum toxin A treatments, observations, and various examinations. Eventually, they were sacrificed for postmortem analysis to study their organs and tissues.
The results were horrifying. In the high dose category, three out of six monkeys faced fatal outcomes. All three were sacrificed due to severe suffering.
The symptoms included tremors, uncoordinated movements, hypothermia, poor food consumption, and dehydration.
One high-dose female monkey showed lethargy, lacrimation, minimal food consumption, and nasal discharge before being sacrificed. Vomiting and salivation were also observed, in the high-dose group.
Tragically, the implications for humans are severe. In 2008, 13 pediatric deaths were documented due to Botox treatments at levels similar to the monkeys.
Despite this, even higher doses continue to be administered today, leading to even more fatal reports. Shockingly,Botox is approved for 10 units per kilogram for pediatric spasticity despite signs of systemic toxicity shown at a lower dose in the monkeys.
This study sheds light on the cruel and inhumane practices of animal testing for botulinum toxin treatments and its potential for harm in people, particularly children.
It’s a call for change and increased awareness about the hidden dangers of both medical and cosmetic Botox.
Join us in advocating for ethical treatment of animals while demanding transparency from botulinum toxin manufacturers. We must help parents, caregivers, and patients achieve full patient safety and informed consent.
To visit Channel 4 News KFOR article, "INVESTIGATION: What many don’t know about popular wrinkle drug," and download a copy of the study click HERE.
In addition, here is a summary of the study for your review.
Key Points:
1. Objective:
    * To investigate the pharmacological effects and potential systemic toxicity of BOTOX administered intramuscularly to the gastrocnemius muscle of cynomolgus monkeys.
2. Methodology:
    * Doses: Monkeys were given 4, 8, or 16 units/kg of BOTOX every other month for one year.
    * Subjects: Both male and female cynomolgus monkeys were used in the study.
    * Parameters Monitored: Mortality, physical observations, body temperatures, ophthalmoscopic examinations, electrocardiography, blood pressure measurements, neurological examinations, body weight, calf measurements, food consumption, hematology, clinical chemistry, urinalysis, and pathology (macroscopic and microscopic observations).
3. Results:
    * Mortality and Physical Observations:
        * High-dose females exhibited signs like poor food consumption, tremors, decreased activity, pale gums, and hypothermia.
        * Some animals showed vomiting and salivation, especially in the high-dose group.
    * Body Weight and Temperature:
        * There were significant decreases in body weight gains in animals treated with 8 units/kg.
    * Pathology:
        * Muscle atrophy and focal degeneration at the injection site (left gastrocnemius muscle) were observed.
        * No significant changes were noted in other organs except for natural variability.
        * Microscopic examination confirmed treatment-related muscle atrophy and degeneration.
    * Antibody Analysis:
        * Out of 286 samples analyzed, only two samples from a high-dose male tested positive for antibodies to BOTOX.
4. Conclusion:
    * Intramuscular BOTOX injections resulted in expected pharmacological effects, including muscle atrophy and focal degeneration at the injection site.
    * The no observed effect level (NOEL) was determined to be 4 units/kg due to systemic toxicity observed at 8 units/kg.
    * The study director was Carol S. Auletta, B.A., D.A.B.T., and the vice president was Ward R. Richter, D.V.M., M.S.
Summary:
The study found that BOTOX injections in monkeys caused muscle atrophy and focal degeneration at the injection site, which are expected pharmacological effects. Systemic toxicity, evidenced by decreased body weight gains, was observed at doses of 8 units/kg. The NOEL for the administration of BOTOX was determined to be 4 units/kg. Antibody formation against BOTOX was rare, with only two positive samples in one high-dose male. The overall findings support the conclusion that while BOTOX has localized muscle effects, systemic toxicity at higher doses warrants caution.
These findings are critical for understanding the safety and pharmacological profile of BOTOX in preclinical settings, providing a basis for further studies and potential therapeutic applications.
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