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Polylaminin Will Be Distributed Free of Charge by SUS After ANVISA Approval; Protein Created at UFRJ Is in Phase 1, Costs Approximately US$ 100 per Dose, and Has Already Been Administered to at Least 30 Patients with Spinal Cord Injury
The polylaminin will be accessible and free through SUS after ANVISA approval, where it is in phase 1 of testing. The announcement was made by Dr. Tatiana Sampaio on the Roda Viva program on TV Cultura on Monday, the 23rd.
The biologist from UFRJ stated that the production of polylaminin will be made available to the Ministry of Health for distribution in public hospitals throughout Brazil.
According to her, this is the agreement made with Dr. Pacheco, owner of Laboratório Cristália and the sole partner in manufacturing.
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According to the researcher, the laboratory’s commitment is to ensure that no Brazilian needs to pay for treatment after regulatory approval. This statement was made during an interview with journalist Ernesto Paglia.
Polylaminin in SUS and Commitment to Free Access
Dr. Tatiana emphasized that the offer of polylaminin through SUS depends on the completion of phases 1, 2, and 3 conducted by ANVISA, responsible for evaluating safety, efficacy, and dosage in humans.
There is no set deadline for official release. The agency follows its own scientific protocols for the analysis of medications. In the meantime, Brazil awaits the results of ongoing tests.
The medical team trained by the researcher is the only one authorized to administer the injection for spinal cord injury. The professionals travel to different regions of the country, with expenses covered by Laboratório Cristália.
Cost, Patent, and Exclusive Production
During the program, the scientist explained that the production cost of polylaminin is around 100 dollars, approximately 517 reais at the current exchange rate for the U.S. dollar.
The production is exclusive to Laboratório Cristália. The researcher warned of possible scams and highlighted that she does not have social media. Profiles with her name are fake.
Regarding the international patent, she clarified that there was no relation to cuts in federal funding. She informed that UFRJ itself decided not to maintain the payment for cost-saving reasons.
The national patent was preserved with a payment of one thousand reais made by her, to avoid losing the rights.
Scientific Debate and Control Group
When asked if she had discovered the cure for paralysis due to spinal cord injury, the biologist stated that she considers the expression strong. She said it is a promising substance, with unprecedented results, but still under research.
When prompted about the need for a control group with a placebo, she responded that a control group is not used in pilot studies. She stated that doctors need to study before making statements.
She added that she conducted tests with a control group of mice and dogs but refuses to apply a placebo in humans who have up to 48 hours to receive the medication after spinal cord injury.
Initial Results and Application in Patients
The polylaminin has already been administered to at least 30 patients. Of these, six received the medication during research conducted at the university.
According to the researcher, over 75% showed motor gain. The scientific literature indicates that about 9% of people with spinal cord injury have an average chance of spontaneous motor recovery.
The first tetraplegic patient who regained the ability to walk after administration was banker Bruno Drummond de Freitas. The scientist emphasized that not everyone will have the same result, as each case is different.
Change in Protocols and Repercussions
The biologist stated that she had to create new study methods in the UFRJ laboratory to develop the polylaminin. She also said that science will need to evolve to create new protocols for this type of case.
She assessed that the significant publicity has both positive and negative sides. The negative aspect is generating high expectations in people with spinal cord injuries.
On the other hand, exposure on social media contributed to ANVISA accelerating procedures. The Minister of Health, Alexandre Padilha, also mentioned polylaminin publicly.
The researcher stated that continuing the research is costly. Nevertheless, she continues to divide her time between interviews and work in the laboratory.
In the meantime, the country is monitoring the testing phases, awaiting the final evaluation from ANVISA for polylaminin to be officially released and integrated into the public health system.
With information from Só Notícia Boa.
Donde la puedo conseguir? Por favor, mi esposo tiene daño medular tiene paraplejia tiene apenas 6 meses de la lesión
Glória à Deus! Parabéns Dra Tatiana e que esse tratamento chegue logo ao alcance do maior número de pessoas, inclusive eu que sou paraplégico a quase 15 anos.
Viva Tatiana Sampaio e universidade pública brasileira!