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William Saad Hossne

William Saad Hossne: The guardian of bioethics

Eduardo CesarWilliam Saad Hossne, 86, is known for his work and militancy in bioethics, an interdisciplinary field that combines biology, health sciences, philosophy and law, and examines the ethical dimension of how to treat human and animal life in the context of scientific research and its applications. The author of a reference work on the subject, Experimentação em seres humanos (Experimentation on Humans), Saad Hossne founded the Brazilian Bioethics Society and helped establish the National Commission for Ethics in Research (CONEP), which he led from 1996 to 2007. CONEP established a research ethics monitoring system consisting of more than 600 committees at hospitals and universities across the country. He currently coordinates the graduate course in bioethics at the São Camilo University Center in São Paulo.

Before devoting himself to bioethics, the professor, who was born in São Paulo in 1927, had a long career as a physician, researcher and science and technology manager. He graduated from the USP School of Medicine as a surgeon specializing in gastroenterology, and, in 1962, was one of the founders of the School of Medical and Biological Sciences in Botucatu, where he is now an emeritus professor. The institution, founded as a separate entity, became part of the Universidade Estadual Paulista (Unesp) in the 1970s. He was also president of the Federal University of São Carlos from 1979 to 1983. He participated in the establishment of FAPESP, becoming the Foundation’s second scientific director from 1964 to 1967, and returned to occupy the same position from 1975 to 1979. In the following interview, he recalls some of the key moments of his career and FAPESP’s early years.

You finished your medical degree in 1951 at the USP Medical School. What was your training and your first contact with research like?
I came from a middle-class family. My parents married in 1926; he was 30 and she was 20-something. My mother got pregnant and my father died the same year, in September. I never met my father. It is a blow to a child when he learns these things. I was raised by my aunts and uncles and grandparents, with whom I lived. One of my uncles was like a father to me. In his early 40s he was diagnosed with cancer. He died a year later, the same year I took the entrance exam for medical school. I monitored the disease, read up on it, and at that time I noticed that the physicians should have been conducting more research. In 1946, I entered medical school with that romantic idea that young people have, but unfortunately lose along the way, of bringing together the practice of medicine and research. The desire to not only treat a disease, but to also improve knowledge about it. I worked in a lab beginning in my first year. When I graduated, in 1951, the world was at an important turning point. It was the postwar era, when Brazil established the National Research Council, for example. It was an interesting environment for those who liked to carry out research and it excited me. I applied to be a surgical resident and went to Santa Casa to specialize.

Who was important in your training?
At Santa Casa, one physician in particular was a great help to me, Dr. Oscar Bueno Nestarez. I learned a lot about surgery from him. He was not an academic, but he had very good training. I took a position as an intern at the Hospital das Clínicas (HC). I wanted to be a surgeon, but I sought an internship in clinical medicine. I thought it was important, before going into surgery, to understand clinical medicine well, mainly to be able to perform the appropriate examinations. I worked with Professor Munhoz Cintra, who later became a professor and dean at USP. When I graduated, a position at the Hospital das Clínicas (HC) emergency room opened up and I got the job. In the early 1950s, it was the only emergency room in the city of São Paulo and a great school. It was we, the surgeons, together with the orthopedists, who ran the ER. I had the pleasure of experiencing the establishment of the specialties. And I chose gastrointestinal surgery.

Age: 86-years-old
Specialty:
Bioethics; gastrointestinal surgery
Education:
University of São Paulo (USP) School of Medicine
London School of Hygiene & Tropical Medicine, University of London (doctorate)
Institution:
Botucatu School of Medicine (Unesp)
Scientific Production:
More than 150 scientific papers and 6 books

At that time you went to work in Sorocaba. What took you there?
The professor I worked with at the HC, Eugênio Mauro, invited me to be an assistant professor at the Sorocaba School of Medicine. He was an associate professor, a man with fantastic cultural knowledge. Within seven years of graduation, I was already teaching and I felt compelled to apply for a permanent position. I did a thesis in experimental surgery for promotion from assistant to associate professor in Sorocaba. That same year I took the promotion qualifying exam at USP, but in clinical surgery. At that time, experimental surgery was based on technical training using animals. I had already seen that experimental surgery, in more advanced centers, was starting to bring clinical problems to the laboratory, using experimental models. Later, when I went to Botucatu, I established the first experimental surgery course in Brazil with the idea of training the researcher who then takes problems to the laboratory.

That’s the concept of translational medicine that everyone is talking about now…
Exactly. I was shocked by the practices of some surgeons, who thought up a new technique and took it straight to the patient. I didn’t think that was appropriate. At that time, scientific research in medicine was changing due to the introduction of scientific methodology. Reporting on cases was no longer enough. It was then that I met Paul Vanzolini, because he often visited the emergency room where I worked. We became good friends, a friendship that lasted until he passed away. I really miss him. He was hired by Prof. Munhoz Cintra to do statistical work for the doctors, which shocked the medical world. It was said that you could only measure medicine qualitatively, not quantitatively.

And Vanzolini helped out in the discipline?
He took care of us. I was preparing my thesis for promotion to associate professor in 1958 and he helped me perform the statistical analysis of my data. Today this would be considered a mistake, because you first need to define your research objectives and then analyze the data, but at that time it was a novelty. I told Vanzolini what I had done and he replied that the data were not useful for anything, because I should have planned beforehand. I said “okay” and threw everything in the trash. “Let’s start from scratch, then,” I replied. He smiled and said he liked me, pulled the stuff out of the trash, and we started working. I began to help Paulo Vanzolini, because he provided this type of assistance to any physician who needed it. After two or three years, he invited me to teach in the discipline. Later I ended up being responsible for it.

You were working in academia when FAPESP was established in 1962. What was the environment in the academic community like at that time?
I closely followed FAPESP’s beginnings. Vanzolini was preparing the law and showed it to me. At that time, Governor Carvalho Pinto’s first action plan had been successful, and he was preparing a second plan. The second time around, the government wanted to include the university. Ulhoa Cintra, president of USP at the time, appointed a multidisciplinary committee from fields such as physics, chemistry, biology, medicine, and veterinary medicine to determine what the university needed. I worked with Crodowaldo Pavan, with Marcelo Moura Campos, Oscar Sala, and Ruy Leme, who was president of the Central Bank. We performed a survey, each in his own area, and presented the results. The governor and the university’s president were thrilled with the results. At that time, the work being done with regard to the so-called “molecular revolution” was also notable. I understood at the time how the revolution could change the entire approach to basic and applied biology and I thought it would influence the applied courses. I’m mentioning this study at USP, the idea of FAPESP and the founding of FAPESP, all together, because these experiences allowed me to propose the establishment of a center for basic and applied biological research. The idea was to bring the biomedical researchers together and make them work alongside researchers who were proficient in the new biology. For administrative reasons, the center was not created. At that time, Botucatu, like every upstate city in the 1960s, fought to have a school of philosophy, science and humanities. The construction of a hospital for tuberculosis in the city, took so long that when it was ready, there was no longer any need for that type of hospital. The mayor of Botucatu was a friend of the governor and pressed him to set up a medical school using those facilities. The president of USP, Ulhoa Cintra, called us and asked us to use my idea, which was to follow the example of U.S. universities created in small towns, where everyone does research. Instead of founding a medical school, they decided to establish a center for medical and biological sciences, with four linked schools. At that time it was a pioneering idea. When the experiment reached its second year, I was called to help. I was the FAPESP scientific director, but I felt compelled to go to Botucatu.

Can you to talk about the results of your first term as FAPESP scientific director and on your return to FAPESP 10 years later?
FAPESP was established in 1962 and its first scientific director was Warwick Kerr, an extraordinary person who sought to turn FAPESP into a serious entity. He wanted FAPESP to be a success. Kerr was removed—or rather, he stepped aside. He had been arrested before and decided to go to Ribeirão Preto. When I took over, I started with Kerr’s plans and tried to expand them, with a few basic focal points. We made a point of learning from the experience of others. And the trajectory of the CNPq [National Council for Scientific and Technological Development], which had already existed for a decade, was important. We looked at what was and what was not working at the CNPq, so we didn’t make the same mistakes.

For example…
It was our feeling—me, Paulo Vanzolini and Aziz Ab’Saber—that we should prevent FAPESP from having permanent administrative commitments and expenses. The CNPq had to manage institutes and this turned into a bottomless pit. FAPESP can provide support to an institution and to a researcher, but administration remains the responsibility of the institution. Another important point was to limit overhead. A 5% budget ceiling was set. There was great concern that everything should be done with scientific seriousness. Projects had to be of high quality and be assessed with transparency and seriousness. Another challenge was that it was 1964, a period of political turmoil in Brazil. We had to prevent any political interference in the granting of scholarships and grants. We came up with a slogan: FAPESP is the researcher’s home. Here we talk about research. It is not a forum for politics or a place to say “I like you” or “I do not like you.” We carefully chose peer reviewers. We had information on advisors who blackmailed their graduate students. If the student did not do what the advisor wanted, he was not allowed to ask for a scholarship. We took great care with this, especially for undergraduate research internships. The order was as follows: the undergraduate research internship student deserves an excellent advisor, because that is the most important phase in training new researchers.

Were there cases where proposals by full professors were rejected, while those of their assistants were accepted?
If the assistant’s proposal was good, he received funds. If the professor’s was bad, he didn’t. The most important aspect was to give a reason for rejecting the proposal. We talked to the researcher and explained our decision. There were some hilarious situations. I remember one researcher A who submitted a proposal and I sent it to peer reviewer B. Coincidentally, B had also submitted a proposal and I sent it to A for his opinion. The identity of the reviewers, of course, was confidential. So A received B’s and B received A’s. One went to FAPESP to complain that the reviewer knew nothing about the area, and that we should be more careful and send the proposal to so-and-so, who was precisely the researcher who had provided the opinion.

FAPESP was visited by the military in 1964. What happened?
They wanted to know how FAPESP worked, if we knew who was a communist. I said that that was not one of the parameters taken into consideration. They asked for the names of the peer reviewers. I replied that they were confidential. A general insisted and I told him to ask the governor, because I was resigning that very day. In the end, he gave me his card and suggested that I seek him out if I encountered any problems. His last name was Bethlem. He was a relative of General Bethlem, who later became Minister of the Army.

What was FAPESP like during your second term there, in 1975?
I didn’t know that my name had been included on the short list. I didn’t know Dr. José Mindlin [Secretary of State under Governor Paulo Egydio Martins]. He called me and told me that I would be selected as scientific director. I was flattered. When I finished my first term, I was once again on the list of candidates, but declined because I had the commitment in Botucatu. But Mindlin’s offer 10 years later was something I could not refuse. He was a great man, and helped us out during difficult times. I was able to assess what went right and wrong during my first term. Some things became clear. First, the importance of the undergraduate research internship grant. Those who did an undergraduate research internship went on to do a master’s and PhD more quickly. There was also a complaint that the number of scholarships had increased compared to research grants. It had, indeed, grown, because there was less demand for large projects.

What had been done?
We went looking for gaps and encouraged the submission of proposals to fill these needs. The permanent exhibition on the Amazon, for example, increased the collection of fish at the Goeldi Museum five-fold. That was a FAPESP initiative. Ab’Saber noted that the geography researchers did not have a collection of aerial photographs. We established a collection. The different chemistry areas were being brought together on the USP campus. I asked Paschoal Senise what he thought we should do. He recalled that the groups did not have people who specialized in the chemistry of natural products. And so I asked him who the right person would be. He said that he could only think of Otto Gottlieb, in Belo Horizonte. I called Otto and suggested he create a group for the area at USP. He was the one to establish the link with the chemistry of natural products, so prominent in Brazil today. There was a time when the Ford Foundation reduced its support for Cebrap [Brazilian Center for Analysis and Planning]. We called the researchers, assessed the projects, and some started to receive funding from FAPESP.

Was political pressure still strong?
The federal government had issued a decree stating that the names of the scholarship holders abroad should go through the National Intelligence Service (SNI). This created an obstacle. The response could take a while and possibly result in political interference. I told Mindlin we needed to find a way around that. He maintained that we not send any names, and then we’d find out if that was an option: “We would stand together, or fall together.” I contacted the Ministry of External Relations, talked to an ambassador, and said I would not send a list. He said that he knew who he was talking to and that it was all right not to send the names. So all scholarship holders’ names were submitted to the SNI except FAPESP’s. And what happened? They sent us the CNPq scholarship holders who needed to travel and could not wait for the SNI’s approval. Later, they reimbursed the funds.

You were also president of the Federal University of São Carlos. What was your time there like?
I was at the end of my second term as scientific director at FAPESP and researchers at the Federal University of São Carlos came to talk to me. There had been a change in president and they wanted someone in line with what São Carlos wanted to be, a university similar to the Botucatu School of Medicine. I suggested we make a list of respectable people and invite them to give a talk about the university. They accepted the suggestion and invited me to the first speaker. I went. When the community vote—which didn’t count—was tallied, I’d received 70% of the votes. But I didn’t think I would be chosen because at the time I was involved in an episode in Botucatu with the riot police. The president wanted to evict the students from a room in the academic center and we protected them. But I was appointed. It was a rich experience in which I was able to make a major transformation, but this was due to the community that supported me. We took planning seriously. We were able to lift the university, which was in 32nd place among the 34 federal universities at that time in terms of quality indicators, into 4th place.

When did your involvement in bioethics start?
In 1985, a professor of statistics named Sonia Vieira and I published a little book called Experimentação em seres humanos (Experimentation on Humans), in which we analyzed cases of abuse. We proposed that it was time to have ethical guidelines for research involving human subjects. After the book came out, I founded the Brazilian Bioethics Society. It grew, and soon the first course on bioethics in Brazil appeared. Later, I was nominated by the Brazilian Health Council to discuss ethics and health, in 1992, 1993. And there I proposed that rules be established on ethics in research with humans and that the guidelines be not professional ethics, but rather bioethics in the broadest sense. An interdisciplinary group was appointed and I had the honor of presiding over it; of the 13 people, only five were physicians. We obtained data from three ministries: Health, Science and Technology, and Education. We mapped 30,000 people or entities that could contribute. We sent an outline of what we were thinking. We asked for suggestions. We wanted our system to have the force of law. And we achieved this aim. This system is under the aegis of the Brazilian Health Council. We established a system for social control in the positive sense of the words. It is independent and managed by the multidisciplinary Research Ethics Committees of the various institutions. Any institution that carries out research needs to have its own. There are more than 600 committees. They cannot have more than half of their members be from a single area. Imagine what it was like to tell a physician that his proposal would be reviewed by 10 or 12 people, only half of who would be physicians. Now I have another dream that I will accomplish.

What is that?
I want to create a bioethics system for health care, along the lines of CONEP [National Commission for Ethics in Research], with committees in the National Healthcare System and in private hospitals. When I see a chaotic hospital on TV, I just cannot stand it. Every institution with more than 20 physicians has a professional ethics committee. I ask myself: where are the committees of these hospitals that are falling apart? When you are admitted to a private hospital, you have to sign a paper indicating that you agree to the hospital’s rules. But these rules are not approved by anyone. These committees will create the rules and monitor them.

What do you think about the complaints against CONEP?
The issue is complex and deserves an article of its own. Anyone should feel free to submit complaints against CONEP without fear of retaliation, and their complaint will be considered impartially, especially when it is a question of ethics. On the other hand, the criticism must be founded, backed with evidence and directed to the correct person. During the period from 1996 to 2007, all complaints were properly handled. In addition to “non-specific” complaints, clearly made under pressure due to conflicts of interest, there were complaints about the time it took to receive a response. I do not recall any complaint directly related to the conceptual or doctrinal beliefs, affecting one or more of the 196/96 resolutions or their supplements. We have to separate the bioethical aspect of the content from the operational aspect. The complaints, mostly generic, focused on operational aspects, specifically on “delays” or the bureaucratic nature of the replies, falsely attributed to CONEP, often to disparage it. We must remember the provisions in Chapter VIII of Resolution 196/96, which stipulates, “the Ministry of Health shall take the measures necessary for the full functioning of the commission and of its executive secretariat.”

Why is bioethics becoming more prominent?
Looking back at the evolution of science, an important period was the 16th century, during the time of Galileo Galilei. He said that the truth of natural phenomena had to be discovered through observation and that was the start of experimental science. This led to such extraordinary development that, by the end of the 18th century and the start of the 19th, there was an enormous amount of knowledge compared to prior centuries, called the scientific revolution. In the 20th century, we had the atomic revolution, which gave us the ethical responsibility for the atomic bomb. In 1953, Watson and Crick discovered the double helix of DNA, starting the molecular revolution. In the last 50 years, two revolutions have taken place simultaneously: communications and space. At the end of the 20th and the start of the 21st centuries, we had the nanotechnology revolution. When all of these come together and we add information technology, we’ll have a sixth revolution. Each leap creates ethics problems that cannot be solved by scientists in one discipline alone. We must involve other disciplines, especially the humanities—sociology, philosophy—to create an ethical foundation. If we are not careful, society could self-destruct. One word has emerged, bioethics, which has a profound meaning. It was natural for me to associate myself with this discipline.

Why isn’t medical ethics enough for research?
We physicians have always performed research on human subjects. What ethics applied? Hippocrates’. It was not enough. In 1932, the United States decided to conduct a study to see if syphilis that was not treated in the traditional way developed differently in black and white boys. The government opened a clinic in a city in Arizona that had a population of black cotton planters and a high incidence of syphilis. Those who went there were to be treated, but left without treatment, because the researchers wanted to see how they died. In 1952, physicians presented this work at a conference and were given a standing ovation. The project was only stopped in 1972 because the press got wind of it. When World War II ended, the abuses of the Nazi concentration camps were made public at the Nuremberg trials. The judges wanted to publish a document to state that what had happened should never happen again. The Nuremberg Code—the first international document addressing the ethics of research in humans—was written. That was in 1947. The World Medical Association resolved to draw up another document in 1964, known as the Declaration of Helsinki. In Brazil, until 1988 we had only those documents. Today, no study can begin without first being approved by an ethics committee. Everything must have patient consent.

Are there cases of violations?
I cannot reveal confidential information, but we have detected abuse. CONEP does not have the authority to punish anyone, but it notifies the Office of the Prosecutor for the Public Interest and the institution. There is a certain condition, which results in severe episodes in adults and children. A physician wanted to study children with the condition, cause an episode to occur, and then separate the children into two groups: one that would receive the new medication and the other that would receive a placebo. It is fair to leave a child in this situation? This is abuse. We refused, but he insisted and was then suspended. This really happened, but it was stopped. But we need to explain our reasoning to the researcher, so that he can reformulate his proposal. When the ethics committee approves a proposal, it becomes jointly responsible. It is not just a bureaucratic job.

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