Introduction
In the intricate world of medical research, where science, morality, and ethics intertwine, the National Bioethics Commission (Conbioética) plays a crucial role: ensuring that scientific trials in Mexico do not compromise patient rights. The current director, Dr. Patricio Santillán, is stirring the pot to establish order; however, his efforts have caused discontent due to delays in authorizing and renewing Committees of Ethics in Research (CEI), a process some believe hinders scientific progress.
The Role of CEI and Dr. Santillán’s Initiatives
Dr. Santillán explains why CEI should not operate as isolated approval offices but be integrated into a medical-scientific ecosystem. He proposes extending the validity of CEI registrations from 3 to 5 or 6 years, adjusting regulations that allow consultancies to register as “medical care establishments” (which leads to poorly-functioning committees), and encouraging private hospitals—many of which already train residents or perform transplants—to incorporate CEI.
The Importance of Integrating Medical Care, Education, and Research
Dr. Santillán highlights the error of treating medical care, education, and research as separate spheres, limiting Mexico’s potential in scientific knowledge production. Among the inconsistencies he points out is the case of private hospitals aiming to perform high-level transplants but lacking CEI, arguing they don’t conduct research. Dr. Santillán challenges this stance: “If you have residents, the university will ask for research projects. This benefits your patients, doctors, and even your business.”
Addressing Irregularities in CEI Oversight
To tackle these irregularities without stifling research, Dr. Santillán proposes reorganizing to balance agility and rigor. This includes strengthening CEI oversight, fostering partnerships between hospitals and research organizations, and educating the private sector on integrating research as part of their mission. “Ethics is non-negotiable,” he asserts. Conbioética, aware of private sector complaints, seeks to streamline processes without compromising patient safety, a principle that should always outweigh any commercial interest.
Conbioética’s History and Relevance
With 32 years of history, Conbioética was founded in 1989 as a study group by figures like Dr. Manuel Velasco Suárez and formalized in 1992 under the General Health Council. Its mission is to safeguard ethical and robust clinical research.
The Rise of Bioethics
Bioethics, a term that will soon celebrate its centennial since German philosopher Fritz Jahr coined it in 1927, gained prominence in the 1970s when technological and scientific advancements transformed medicine. Innovations like mechanical ventilators, which saved polio patients’ lives, and hemodialysis, offering hope to those with kidney failure, brought profound ethical dilemmas. Questions like “Who deserves renal replacement therapy when machines are scarce?” and “When should a brain-dead patient be disconnected?” emerged, even reaching the Vatican. These questions led to the creation of CEI, tasked with overseeing research protocols to ensure scientific advancement doesn’t violate human rights, as seen in Nazi concentration camp experiments or U.S. studies where participants’ rights were ignored.
Mexico’s Legal Framework and CEI Deficit
Mexico’s General Health Law stipulates that hospitals conducting research must have CEI. However, of the 1,200 hospital bioethics committees registered, only 383 are CEI. This deficit reflects a misconception: many hospitals, especially private ones, view themselves solely as medical care centers rather than research spaces. It’s time for them to understand: “Ethical clinical research is a moral obligation,” emphasizes Dr. Santillán.
Balancing Innovation and Protection
Conbioética identifies a critical issue where bioethics committees operate in consultancies or as contract research organizations (CROs), approving protocols executed far away without proper oversight. This practice not only violates local registration norms but also poses risks to patients and generates conflicts of interest, as some committees charge per review, creating incentives to prioritize business over ethics.
Mexican Innovation: Vitacor Artificial Heart
Speaking of national innovation, today cardiologists are presented with a high-specialty medical device generating hope and encouragement: a ventricular assistance device with the unmistakable “Made in Mexico” label, making it the first fully developed artificial heart in our country. This medical device, Vitacor, is already authorized by Cofepris, launched by the company Vitalmex, which invested for a decade in this project. Its founder and president, Jaime Cervantes Hernández, shared this development in an interview a few months ago, and it’s now a reality. Undoubtedly, this Mexican company is advancing to the next level: from a medical supplies integrator to a company developing and selling innovative products for medical care.
Changes at INER’s CIENI
Attention-grabbing changes have occurred at the National Rehabilitation Institute (INER), specifically at the Infectious Diseases Research Center (CIENI) known for the lymph node protocol criticized for poor practices in young VIH-infected patients and diversion of resources from foreign universities. On May 27, Santiago Ávila Ríos, CIENI’s director and the protocol’s responsible party, was asked for immediate resignation. He had remained in charge for years despite not being a medical professional. It’s assumed that Dr. Gustavo Reyes-Terán, now INER’s medical director and former CCINSHAE coordinator, no longer wields the same power.
