UEPG cancels survey after pressure from animal activists

Summary of this report:

• The development of an artificial sphincter, which would significantly improve the quality of life of people with a colostomy, was interrupted in April by the State University of Ponta Grossa (UEPG) after pressure from animal activists.
• The last stage of pre-clinical testing would consist of implanting the device in six Beagle dogs, which would be followed up for a year and then destined for adoption.
• After the intervention of an NGO from Paraná, the university denied that it maintained ties with the research project, which is contradicted by documents issued by the institution received by the reporter.
• The prototype has been under development for 30 years and was a finalist for two international awards. Now, with the project at a standstill, the device’s creator is waiting for another institution to open its doors to continue the tests.

The action of animal rights activists interrupted the development of a device with the potential to significantly increase the quality of life of people with a colostomy, that is, people who, due to problems in the digestive system, have a connection between the large intestine and the abdominal wall that allows the output of feces into a collection bag.

In development for 30 years, and currently in the last phase of pre-clinical tests that precede trials with human beings, the research for the creation of the device called Aico (acronym in English for Active Implantable Occluder for Colostomies) were suspended in April by UEPG after pressure from an NGO.

The intimidation even included the threat of activists invading the place where six female Beagle dogs were kept, who would participate in an experiment essential to the advancement of the research. The NGO, called Grupo Fauna PG, presents itself as a “group in defense of animal and environmental rights”.

The device under development is an implantable artificial sphincter that can be activated by remote control and is capable of returning control of evacuation to colostomy patients. In practice, these patients, who depend on the uninterrupted use of equipment attached to their abdomen, could be freed from collection bags, which generate various limitations and discomforts.

In Brazil alone, there are more than 400,000 people with different types of ostomies, according to an estimate by the Ministry of Health. But the innovation would have the potential to benefit an even greater number of patients in other countries, as the international scientific community has been looking for similar solutions for decades. People with other types of ostomas, such as ileostomy (small intestine), gastrostomy (stomach) and urostomy (bladder) could also benefit from the mechanism in the future based on small adaptations.

Even so, the project has been parked since April 20, the date on which UEPG suspended the development of the research, which was being coordinated by the creator of the Aico, Josuê Bruginski de Paula. Physician and PhD in Biomedical Engineering, the researcher was a professor at the university of Paraná for ten years and left the position to dedicate himself exclusively to the development of the Aico.

With the decision, the pre-clinical tests initially scheduled for April 21 to 23, which would consist of performing a colostomy surgery on the dogs, with the insertion of the device to test the effectiveness of continence, were canceled. The animals would be monitored for a year, and at the end, a new surgery would be performed to reverse the ostomy, in the same way that it is done with humans. At the end of this process, the dogs would be sent for adoption.

The NGO, however, went on to claim that the animals would be victims of mistreatment, which is denied by the researcher, and to demand that the university not only prohibit the use of its facilities for the procedures in question, but also abstain from to carry out any further research on animals.

On the eve of the start date of the procedures, the UEPG released a note stating that the use of its facilities for the research in question would be a “rumor” and that the institution had been sought out for the location of a laboratory, but “as soon as it took aware of the intentions of the study, immediately canceled all negotiations”.

However, the university was aware of the research at least since 2016, when the university’s Ethics Committee on Animal Use (CEUA-UEPG) issued a letter of authorization to carry out research with dogs. In September 2021, the sector issued a new letter reinforcing the permission for the experiment, which invalidates the thesis that the institution was unaware of the project. There were even professors and collaborators from the university involved in the research.

“I have ostomized patients who have followed me since 2007 waiting for this device. But the cry prevailed over the argument, and in an anti-science thinking, the current direction of the UEPG decided to cancel the research. It was a sequence of judgment errors that is harming ostomates not only in Brazil, but all over the world”, said the researcher to People’s Gazette.

The report contacted UEPG asking for a position on the case. There was no response until the closing of this report.

The NGO, on the date the survey was cancelled, released a note condemning the use of animals in all forms of scientific research. “We question how UEPG is training future professionals by agreeing that sensitive lives are just products to be manipulated and discarded. We have fought and will continue to fight for respect for all non-human animals.”

Animal testing is not only permitted, but required for the registration of drugs, vaccines and medical devices

For drugs, vaccines or medical devices, such as the artificial sphincter, to be approved in Brazil, the legislation requires that the product undergo pre-clinical tests, in which the use of animals is often essential. One of the objectives of this stage of testing is precisely to evaluate aspects related to safety, to then progress to clinical trials, carried out in human beings.

Resolution 466, of the National Research Ethics Commission (Conep) – a body of the National Health Council (CNS) whose main attribution is to examine the ethical aspects of research involving human beings – determines that research that uses experimental methodologies in the The biomedical area involving human beings should, among other measures, “be based on previous experimentation, carried out in laboratories, using animals or other experimental models and scientific evidence”.

To ensure that all animals used in teaching activities or scientific research are guaranteed dignified, humane and ethical treatment, the National Council for the Control of Animal Experimentation (Concea) was created in 2008, which is linked to the Ministry of Science and Technology. . In early May, the agency issued a specific Normative Resolution to guide scientific experimentation with the use of dogs and cats.

The National Health Surveillance Agency (Anvisa), in order to proceed with the registration of a medical device, requires that the product has been previously tested on animals, as mentioned in the Resolution of the Collegiate Board (RDC) 548 in Annex 2, item 9.

In the same law that instituted the Concea, the Commissions for Ethics in the Use of Animals (CEUAs) were also created. At universities, these bodies must have veterinarians, biologists, professors, researchers and at least one representative of animal protection societies. It was precisely this UEPG body that issued two authorizations, in 2016 and 2021, for research on artificial sphincter using dogs. Dogs were chosen because they are mammals that, like humans, have the ability to control defecation, with the colon acting as a reservoir for feces.

“For medical devices, drugs or vaccines, for example, studies on animals, called pre-clinical studies, are mandatory both in Brazil and in most parts of the world. This started to happen after the second world war, when the Nazis used human beings in research in a criminal way”, explains José Roberto Leite, doctor in Biological Sciences, professor at the University of Brasília (UnB) and scientific consultant of the People&Science.

The professor states that more and more researchers have resorted to alternative approaches without the use of animals, such as methods in vitro, use of human tissues from autopsies and mathematical and computational models. However, there are cases where animal testing is essential.

“The Brazilian legislation that addresses the use of animals in research establishes that researchers and institutions must adopt measures to promote the well-being of the animals used, guaranteeing adequate housing, food, hygiene and veterinary care”, he points out.

Stopped research and ostomates waiting

With the closure of UEPG doors and the consequent parking of the research, Josuê Bruginski is now waiting for another institution to host the project and allow the tests to be carried out. Meanwhile, people with an ostomy are waiting for a way out to ease the challenges of living uninterruptedly with an ostomy bag.

For Katia de Oliveira, president of the Paranaense Association of Ostomized People (APO), who reported the case to People’s Gazettethe action of the activists first of all disrespects patients who have been waiting for years for a technology that will allow ostomates to no longer need to make continuous use of collection bags, responsible for a series of problems derived from excessive contact with the skin.

“I have two dogs at home, who sleep in my bedroom and move around my house as part of my family. We care a lot about stray dogs and we even help one of these institutions financially. But, in this case, they are paying more attention to animals than to people”, says Katia.

“When a solution appears that can help bring quality of life to ostomates, they veto it thinking about the animals, who were being well cared for and would be adopted after the procedure, it gets to be grotesque”, he vents.

Stationed in Brazil, the project is a finalist for two international awards

The first prototype of the artificial sphincter was created in the 1990s during Bruginski’s doctorate at Unicamp, which earned him the XIV Young Scientist Award, granted annually by the National Council for Scientific and Technological Development (CNPq). In 2007, an improved version of this prototype was the only foreign finalist for the French Altran Foundation award. Seven years later, the project received R$1.2 million in public funds from the Financier of Studies and Projects (Finep) to make it viable.

Currently, the prototype is one of the 60 finalists of the Euro Innovation in Health Award, a Eurofarma initiative that recognizes great innovations within the health area and has participants from 17 countries. “The product is really innovative. Several countries around the world are trying to find a solution to this. It would be a high-tech Brazilian product for the world, but it ran into an immediacy response to a false complaint of abuse,” says Bruginski.

“Now we are looking for an open door, an institution that defends scientific thinking. It is sad, because universities should be a stronghold for the defense and formation of dialogue, of scientific thinking. But unfortunately that was not what happened”, regrets the researcher.