Although the politics of human research were quite apparent as soon as I became involved with clinical pharmacology in the late 1970s, the stem cell question was beyond my vision in the 1990s. I had decided to go into Neurology in 1975 during medical school and ended up in epileptology because I was offered a job during my PhD in clinical neuropharmacology of benzodiazepines and antiepileptic drugs. My introduction to the field of immunology came because throughout the 5 years I remained in London I was close to and then became a resident with John Newsom Davis. I ended up prescribing and looking after the first patients in the world to receive high dose steroids, plasmapheresis and azathioprine for neuroimmune diseases. I did not appreciate at the time that something rather more revolutionary, the work of Medawar’s group, was taking place in Harrow, just outside London, while getting Nobel prizes along the way. At the time I had 2 careers, and neuroimmunology was part of my clinical career.
Politics of human research was quite an obvious daily fact. There was a great preoccupation with ethics after the Nazis and while the Soviets, Latin American, Franco and African dictators were still in power. The ethics needed to be correct. Upon returning to Brasil, we were 2 clinical pharmacologists in the whole country. We were thought to be either pharmacists or pharmacologists. Nobody knew what clinical pharmacologists were for, and I believe they still don´t. To this day, as the indiscriminate shame of generics and “similares” proves, Brasil ignores clinical pharmacology, as it ignores nuclear engineering. And that is why scientific Nobel prizes will never come here. We have a tendency to ignore Science. Our universities teach, they do not produce Science.
Soon we had the first cases of the AIDS epidemic, and a very early paper in the journal of the Regional Medical Council, one of the first to deal with stigma and prejudice in medical care of any disorder, certainly of AIDS and of people with sexually related diseases. Certainly AIDS places the politics of human research on the radar of the common man on the street.
There is in Brazil medical ethics directed by the State Medical Councils accredited by law to give and take medical diplomas and degrees of specialties. They were established in the late 1950s, to be responsible for judging the conduct of physicians, keeping the code of medical ethics, and they hold the legal responsibility for the profession. Ethics in Research appeared in the 1980s when drug companies needed to obtain permission to insert new drugs in newly liberal economies according to the laws of the FDA and of the European Market.
A list of my clinical publications in the first 8 years in Brasil gives a picture of what was publishing clinical research when there was no ethics committee in the vicinity. My publications were the first clinical series in Brasil about MS, Alzheimer´s disease, clinical trials of antiepileptic drugs, spinal cord infarcts, and many other topics. In Brasil and internationally there was a movement for the establishment of human rights in general, and in a few years, ethics and ethics in research committees were established around the world. I had a decisive and very early participation in this movement.
My involvement with the ethics of brain death was documented by Eelco F.M. Wijdicks in Neurology in 2002 (58: 20-25). My second ethical involvement was in the establishment and participation of the first ethics committee of Hospital Nossa Senhora das Graças. But the third ethical involvement was the most complex. My private company, Unidade de Neurologia Clínica, was the first private company in Brasil to have a clinical research ethics committee registered in the National Health Council of Brasil, in 1989. Unidade de Neurologia Clínica was certified by the National Health Council as a center with the capacity to run clinical and basic science trials of new pharmacological compounds and has its Internal Review Board certified by National Health Council, the first private and the first neurological institution in the country, in 1990. Then Unidade de Neurologia Clínica had its Internal Review Board certified according to new rules by National Health Council, in 1998; in 1999 this IRB expanded to include Hospital Nossa Senhora das Graças. Throughout this time it was my company, with its own funds, personnel and contacts that maintained the committee functioning according to the very strict rules determined from Brasilia and internationally.
We were very early pioneers in the field of ethics in research. Unfortunately, the hospital went into a financial tailspin and the clinical research unit was closed down. With this event, my clinical research career came to a halt, because our clinical research ethics discussions were transferred to Hospital de Clínicas da Universidade Federal do Paraná, where we were blocked politically. That was sometime in 2007. By this time the Comitê de Ética em Pesquisa Clínica da Unidade de Neurologia Clínica, later of Hospital Nossa Senhora das Graças, had functioned under my responsability, officialy authorized by the Brazilian National Health Council, for 18 years.
This was, of course, of no avail, when a group of people decided to destroy poor old cyclophosphamide and set out on a cavalry and infantry assault on it, and ended up being able to publish in the internet a notice that said the Brazilian Academy of Neurology ethics committee had found something wrong with the use of cyclophosphamide and sclerosis, thus frightening away all patients and physicians that might be of interests contrary to those of their pharmaceutical sponsors, including systemic sclerosis, multiple sclerosis, amyotrophic lateral sclerosis, and so on. One of these companies had spent 20 billion dollars just on the same month as this action took place in the Brazilian academy, when they purchased the company that owned alemtuzumab, Genzyme Corporation, which of course, may be just a coincidence.
Dr Paulo Bittencourt
