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INTERGROUP SESSION - Lack of implementation and enforcement of Directive 2010/63/EU on the protection of animals used for scientific purposes - Shared screen with speaker view
The replacement of animals for the potency testing of botox is an example of what industry is capable of when it is motivated to do so. The biggest obstacle to the replacement of animals in regulatory toxicology is not a lack of technology but a lack of political will by governments and industry. A first step towards making progress would be a parliamentary inquiry into the validity of the animal model and the availability of "alternative methods". andre.menache@gmail.com
Reineke Hameleers
@MEPs if you would like to intervene please let me or Andreas know?
Céline Sayah
Annika Bruna would like to intervene
Nicolas Marty
Q: How is it that inspections in Vivotecnia did not see that something was wrong? I don't feel that we got an answer to that.
Please could you publish my earlier comment
Reineke Hameleers
yes we will pick up on all questions after the next presentation
Roland CASH
Q. on transparency : how is controlled the quality and exhaustivity of statistics transmitted by the States ?
francois busquet
What could be adequate metrics to monitor progress in 3Rs besides animals number and funding?
Nicolas Marty
Q - Seeing how it went at Vivotecnia, it seems that "transparency" agreements (Vivotecnia did sign the Spanish agreement) cannot guarantee even the slightest level of welfare for animals. How is that possible? There clearly wasn't the slightest level of actual transparency from Vivotecnia.
Gisela Urban
The LPT consists of around 175 contracts on the contracts in Germany, the studies on behalf of the pharmaceutical and pesticide industry regulated according to GLP (Good Labor Practice).The current scandal was caused by an organization of Soko Tierschutz, who had transformed from December 2018 to March 2019 as an employee in the LPT location in Mienenbüttel in Lower Saxony near Hamburg. Videos he secretly recorded include animals being tortured there.
Gisela Urban
According to employees, a monkey that died in an experiment for a South Korean pharmaceutical company has been replaced with a live one. That was suppressed in the test protocol. Here the fatal incident did not fit into the plan and the undercover agent had to enter information incorrectly. His complaints about it until the management of the plant remained ineffective
Costanza ROVIDA
Regarding the inhalation toxicity test in the video, we should be aware that is the normal procedure. The same is for eye irritation in rabbits and also for pyrogenicity test still in rabbits (it is not clear in the video for which test the rabbits were immobilized). So, at least for those tests Vivotecnia was not infriging the Directive on animal welfare. We should simply stop those tests, in particular considering that accepted alternatives do exist. (Regarding inhalation toxicity, the in vivo model is really unreliable for many reasons)
Kirk Leech
A question for the speakers. I agree that there is a need for honesty in this discussion. Bad practice such as the Spanish CRO needs to be called out and the research sector did, EARA led this condemnation. That said honesty about the benefits of animal use also need to be admitted. The successful vaccines developed to combat Covid19 have relied on animal use, including monkeys for safety and efficacy, before widespread human use. No speaker has mentioned or praised that life saving work by the research community.
Gisela Urban
A second witness reports a similar process in the LPT laboratory in Schleswig-Holstein. Tests are carried out here on potential hazardous substances for the environment. In a rat study, the high death rate and cruel deaths of most animals were covered up, according to the witness. A lower dose eventually produced the desired result.These statements prove the catastrophe of a completely out of control system. Here, permitted abuse, brutal animal cruelty and massive criminal energy encounter a state that is nothing more than a helpless extra. If this was falsified over the years, it also means a great danger for the human test subjects in the clinical studies that followed the animal experiments.After the investigative ARD news magazine FAKT reported on this alleged case of serious scientific fraud in its October 2019 broadcast, several former employees contacted the editorial office and described similar cases of fraud, which were picked up in subsequent broadcasts.Broadcast on October 15, 2019.
Gisela Urban
In the broadcast on November 5, 2019, "Animal experiments - Were test results manipulated?", An anonymized former employee reports on a short-term study with rats. A test substance was administered to the animals in three different dose groups. The animals died just a few days after the start of the experiment. But instead of documenting this result according to the regulations, the dead animals were replaced by new ones and the dosage of the test substance (a drug) was reduced. With this approach one would have achieved a more positive result of the study. The client was not informed about the deadly effect of the original dose and the replacement of the animals. According to other media reports, this case prompted the Kiel public prosecutor to investigate suspected manipulation of study results.Another former LPT employee tells in the above article, also anonymously, that she has both witnessed forgeries and deleted data herself on instruction (original sound):“Not only did I experience it, I did
Katy Taylor
animal studies for covid 19 were not key, the vaccines were re purposed existing vaccines, the monkey studies were done concurrently with the human trials because the regulators needed to see them- they were actually very underwhelming
Gisela Urban
The determined respondents that they have mutually refused must deal with forgeries. As a result, other employees completed this task
Kirk Leech
To Tilly, I have offered you this opportunity before, and I am happy too publicly do this again here - I would very happy to set up a meeting for you with researchers who have used monkeys in research to explain why they use monkeys in such research. You have hey to respond to this offer.
Gisela Urban
In the broadcast on November 26th, 2019, “Cruel Animal Experiments: How Abuses Was Covered Up For Years”, a former employee, who was employed at the LPT between 2003 and 2005 and was the head of hematology for all three locations, reports on the exchange of a deceased monkey at one Cancer study in which a cytostatic agent (cancer therapy) was tested (interview):“These animals, especially in the high dose group, actually had completely open skin - so it was the raw meat to be seen, miserable, really miserable. [...] One animal also died in the high dose group and that was also replaced by another animal. Here, too, the tattoo number, which is located in the chest area of ​​the animal, was cut out from the deceased animal, and it was finally added to the organs of the replaced animal after the end of the study. So that it looks like this animal just hasn't died. "The fifth former employee, who reported on the manipulation and falsification of studies for FAKT, renounced anonymity. He worked for one ye
Gisela Urban
At the request of FAKT, the competent authority for health and consumer protection stated: The active employees were not aware of any evidence of counterfeiting from the time in question. Nothing is on record, because the authorities only keep documents for ten years.The approval procedures for pesticides, active pharmaceutical ingredients and other chemicals worldwide are based on the principle that applicants themselves provide evidence of the safety of their active ingredients. For this purpose, they commission contract laboratories (sometimes also in-house laboratories) to carry out the regulatory studies that are intended to confirm in the approval process that their chemicals do not pose any unacceptable risks.The results of these studies can decide whether or not the drug or pesticide active ingredient examined will be approved for the European market. This can have major economic effects for the client of the study.As a guarantee against manipulation and falsification of these studies,
Gisela Urban
But the current fraud scandal involving a German, GLP-certified contract laboratory shows that this trust is not justified. According to reports, studies have been manipulated and falsified there since 2005.Current research now shows that studies were also carried out at the LPT Hamburg which, together with other studies, formed the basis for the EU-wide re-approval of glyphosate in December 2017: Every tenth GLP study on glyphosate comes from the Hamburg LPT laboratory - these provide invariably gave positive testimony to the pesticide. Around 21 of the 150 new studies on glyphosate named by the BfR come from the LPT.Proof 2: Table GLPSource: Global 2000: https://www.global2000.at/news/glyphosat-studien- BetrugslaborThere is now cause for concern for all drugs, pesticides and other chemicals whose EU approval is based on studies carried out at the LPT that could possibly have been tampered with. What is even more worrying, however, is that contract laboratories (such as the LPT) are apparent