With the Author's permission, we reproduce an article by Professor José Fernandes e Fernandes (Retired Full Professor of the Faculty of Medicine of the University of Lisbon and former Director of the institution between 2005 and 2015), published
The Convergence of Health Sciences with Engineering and the cooperation of physicians and researchers with industry, which transforms the product of research into new drugs or materials - devices - that can safely be used in humans, were decisive for the progress of Medicine. Its benefits have been recognised by the Community, from the eradication of some diseases and the cure of others to the improvement of survival with Quality of Life.
But, as with everything else, there is a counterweight we should not ignore.
Firstly, the cost of innovation which, reflected in the price of the end product, could jeopardise the sustainability of the Health Services and compromise key values such as Equity of access to Curative Medicine, which is an Asset, without economic and social discrimination and in a timely manner. Hence the need, in any process of adoption of therapeutic innovation, for two requirements: (i) careful selection of patients who could potentially benefit the most from it (ii) impartiality and independence of the professionals promoting it. This is the path that should be followed until this innovation dominates the clinical praxis and results in effective health and therapeutic advancement gains.
Secondly, there is a paradigm shift in the Medical Act, as a result of the multidisciplinary and multiprofessional cooperation indispensable in modern medicine, with an impact on the Physician's individual relationship with his/her Patient.
These realities add a new dimension to the Physician's Responsibility, as prescriber and user of the available clinical resources. They integrate the exercise of accountability, which is no more than the duty to do good and to be accountable. And the intelligent incorporation of medical progress and therapeutic innovation into everyday practice is part of this exercise. It is a dual Responsibility that involves the Physicians and the Authorities and should be complementary. For the former, it translates into the preparation of and compliance with clinical guidance standards for Best Practice – Guidelines - and, for the Authorities, into the creation of institutions focused on assessing therapeutic innovation, of which the NICE, in the United Kingdom, and the National Institute of Health (NIH), in the United States, were an example.
And this is a dimension of professional responsibility that I've always regarded as an undeniable duty, through a committed participation in the preparation of international Consensus Documents and Therapeutic Guidelines as part of the activity of the scientific societies in which I participated.
Public and media interest is natural; public scrutiny reinforces the need for the accountability and collective responsibility of all stakeholders.
In this context, the fact that there are complaints and legal proceedings against physicians arising from their clinical action, while fortunately rare in the overall context of clinical activity, has relevance and media impact, with negative repercussions on the public perception of Integrity and Professional Competence which affect the Citizen's Trust in Medicine and Physicians.
In our speciality - Angiology and Vascular Surgery - endovascular treatment was an innovation of the last decades of the 20th century that marked a new level of performance and changed our practice, just as laparoscopy, endoscopy, robotics and other technologies changed Surgery. It caused considerable controversy, especially in the treatment of aortic aneurysms, with committed detractors, but the discussion was open and scientific, as four realities emerged from it: i) Technological development in order to incorporate the recommendations of the professionals and correct the limitations of the initial prototypes - this was also the paradigm of the evolution of Surgery in the last 50 years! (ii) Demonstration of the feasibility and safety of the new procedure (iii) Outlining selection criteria and (iv) Need to assess its potential benefit over conventional treatment through appropriately controlled studies.
The collaboration of physicians, scientific societies, the industry producing these new materials and the Institutions was exemplary and enabled its current spectacular development. And, in recent therapeutic guidelines published by the European and the American Societies for Vascular Surgery (ESVS and SVS, respectively), the endovascular treatment of aortic aneurysms (EVAR) is considered the first therapeutic option provided that the patients meet the appropriate clinical and anatomical requirements.
Its story is well known; I will only recall facts relating to its introduction in Portugal. The first cases were performed by us in 1999 at the ICVL (Cardiovascular Institute of Lisbon). The experiment progressed, while allowing us to acquire expertise and to form a team. This technology was quickly adopted by most of the Portuguese Vascular Surgery departments. And, in Portugal, at the beginning of the second decade of the 21st century, endovascular treatment had also outweighed conventional surgery in the elective treatment of abdominal aortic aneurysm, as shown in a study presented at the SPACV Congress.
All these initial considerations are important to understand the exemplary story I refer to in the title, and upon which it is now possible to reflect. And, in my view, this reflection seemed indispensable, out of self-respect, respect for the Colleagues, for the Patients who trust us, and for human and modern Medicine, to which I have tried to be faithful as a physician, surgeon and scholar. But I also do it for a pedagogical and prophylactic reason, and to defend the precision and prudence required by these matters.
For me, this story began on 30/10/2015, when criminal investigation brigades were deployed for searches at my home and in both my public workplaces - the Santa Maria Hospital and the Faculty of Medicine - and my private workplaces - the Cardiovascular Institute and the British Hospital. Suspicions of improper practices in the selection and use of aortic endoprostheses and the proposal to create the Aortic Surgery Centre were the main evidence, together with the allegation that I was a doctor with enormous power due to the functions I performed and the knowledge I held! Those were the justifications presented in the document called Search and Seizure Warrant .
A few hours after the public launch of the investigations, the Media were addressing the subject, technically under legal confidentiality, extending its impact to a million-euro business and damages to the National Health Service, and showing my picture.
The Case ended on 18/1/2018 with an order from the Public Prosecutor's Office stating it was to be closed and clearing me of any illegal or irregular act. The full text of this order was published in the Justice Portal and I sent copies of it to the President of the Medical Association, the President of the SPACV for filing in the society of which I had been President, and also to the President of the Angiology and Vascular Surgery Specialty College, which I had also presided.
This Investigation Procedure was based on two components: the first one was an anonymous, handwritten complaint filed in April 2014 with the Inspectorate-General of Health Activities (IGAS). It was not investigated for a year - lack of means, was the explanation given to me -, but in April 2015 it was forwarded to the Public Prosecutor's Office. I was only heard by the IGAS in November 2015, i.e., 18 months after the complaint was received, and then I became aware of the full content of the handwritten document which supported it.
The second component was based on statements made to the Criminal Police by the former Clinical Director of the HSM-CHLN, of which we only became aware in 2017 - almost 2 years later - when we were allowed to access the File, one it was no longer under legal confidentiality.
Rereading the justification for the investigations is an instructive exercise. It allows assessing the solidity of the reasoning of the evidence gathered, counterweighted by the reality of the facts on which the suspicions and the final result of the investigations were constructed.
As for the anonymous complaint, a habit cultivated by the Doges of Venice - la bocca de la veritá, which served the preservation of Power better than the practice of Good Justice -, it became popular across societies of Mediterranean culture and beyond. But reporting is also an act of public responsibility, and whoever the author may be, he or she should not hide under the diaphanous veil of anonymity and cowardice! In an article published in the Público newspaper in November 2015, I mentioned the subject and clearly stated that I had recognised the complainant's handwriting.
An accurate, thorough and immediate investigation was required to prove the veracity of these accusations. First of all, out of respect for the Truth and, secondly, for the prestige of the Institutions where, at the time, I was holding management positions in the hospital service and in the medical school, but also for the honour of the Accused, which should be a paradigm in a democratic State supported by the Rule of Law. None of that happened. The IGAS's action did not preserve these objectives and did not even allow the investigation to be completed, with exemplary precision, while I was performing my public duties.
And this is the first lesson! The public responsibility of those who have the duty and the mission to ensure adequacy and integrity in the exercise of Health activities has unfortunately not been fulfilled and this is very serious and unsettling.
The Media transformed a case that was still under investigation into a public accusation, when no facts had been proven. They did not serve the fundamental right of Information, which is intended to be objective and impartial, and ignored another no less important right of every citizen: the right to Good Reputation and presumption of Innocence.
This is the second lesson. Responsibility and Accountability are also requirements for the Media - they are the indispensable counterweight to Freedom of Information. I recommend reading the article that has been recently published by Prof. António Barreto on The Information We Have, which should warrant particular attention.
However, in its essence, this Case substantiated two important issues. First of all, how to incorporate, albeit belatedly, a therapeutic innovation into a public service - in this case, the endovascular treatment of aortic aneurysm - which, in the future, can be any other clinical development. Secondly, the impartiality and independence in the selection of clinical materials, which should always, first and foremost, privilege quality, safety, and results.
In fact, the adoption of any new therapeutic modality, particularly in Surgery, follows demanding principles and rules, because it poses additional risks for patients, potentially dependent on the new technology and the experience of the performers. The desideratum is to minimise these risks, from the professionals' learning curve to the stringent selection of the new devices to be used, as well as to prevent conflicts of interest, illegal personal advantages, and act in an impartial manner. These issues are an exercise of shared responsibility, of the Physicians and Institutions in which they work, and must be addressed with precision, seriousness and continuous evaluation.
For all these reasons, it was crucial to ascertain whether all these rules had been neglected.
In October 2012, when I was appointed director of the Department, I clearly assumed, in the Action Plan submitted to the Board of Directors, the objective of promoting the incorporation of endovascular technology, which was indispensable in an academic department that had turned its back on innovation for too long, and advancing endovascular treatment, while preserving the skills acquired in conventional surgery and, thus, contribute to modernising the therapeutic action of the Department and the training of new Specialists.
This strategy had two pillars: the first one was an internal one, concerning the Department, and the second one was an institutional one, materialised in the rules set forth by the Board of Directors.
As for the former, under the responsibility of the Director of the Department, a decision coordination centre was informally set up, in order to ensure the proper selection of patients, of the materials to be used, and safety while performing the procedures, always involving the clinicians responsible for each patient. The aim was to optimise results, facilitate the learning curve of all the professionals, and ensure the conveyance of knowledge, as is the obligation of a public and academic service. This entire procedure was clear and participated: all the cases were then presented and discussed at the weekly operative scheduling meeting which was held on Thursday and on the day following their treatment, in the daily morning meeting of the Department to report all occurrences, a process that allowed constant monitoring of the activity underway. It had an indisputably formative value and was always based on impartiality and independence.
As for the institutional pillar, the policy followed by the two Boards of Directors while I was director of the department respected all medical decisions, but required a mechanism for their critical evaluation, forcing each case to be strictly justified. The methodology was as follows: i) Comprehensive clinical report of the patient's situation and the reasons selecting the endovascular treatment ii) Proposal of endoprosthesis to be used iii) Final approval by the Director of Department, and iv) Monitoring of the activity through the periodic evaluation of the indicators commonly used to evaluate clinical services, such as mortality rate, average hospital stay, percentage of rehospitalizations, comparison with the case-mix, which is an indicator of the complexity/difficulty of the patients that are treated, financial costs, which were included in the periodic reports prepared by the Board of Directors.
All the teams in the department were involved and were able to gain experience, as one could easily check in the Operating Room records and in the operative protocols, and the excellent therapeutic results were confirmed by the favourable developments in the aforementioned indicators.
All this could have been easily and quickly checked by the relevant authorities!
The strategy we followed was correct. In Clinical Medicine, and in an academic and public service, no one would ever be allowed to act alone, without support and guidance. Clinical management is an impartial, equitable, participated exercise of Responsibility, but this Responsibility is a privilege of the Hierarchy that is undertaken head-on and always in a pedagogical dimension. It is the undeclinable duty of those in charge. As is being accountable, a requirement that has always been fully fulfilled!
In December 2014, the lack of specifications and public tender for the acquisition of heart valves for the semi-invasive or percutaneous introduction of orthopaedic material and aortic endoprostheses was publicly criticised. Those responsible for the services in question immediately requested an audit to the Board of Directors of the HSM-CHLN, which, unfortunately, was never carried out in Vascular Surgery, despite my commitment and also that of the Chairman of the Board of Directors, who confirmed that he had forwarded the request.
Omission never serves the Truth! And that is the third lesson: the Institutions need to have swift mechanisms to respond and immediately clarify any doubts about the activities carried out by the services.
The other issue that, to my surprise, was relevant evidence for the investigation, as mentioned in the Search and Seizure Warrant, was the proposal to create the Aortic Surgery Centre. Its aim was to promote the centralisation of the rarer and more complex cases of aortic diseases, whose treatment requires specialised hospital resources, convergence of skills from various departments, and a multidisciplinary cooperation in an organised effort to optimise the evaluation and quality of treatment of these patients. I defended this operating model in several lectures in Portugal and abroad; it was also in line with the official policy of setting up Centres of Excellence for several rarer and/or more complex pathologies which, unfortunately, had not covered Vascular Surgery.
This proposal, whose logic was unassailable, was considered as evidence of collusion with the Chairman of the Board of Directors of the HSM-CHLN, as its purpose mistaken for the commercial exploitation of aortic endoprostheses, which would explain a trip to the Netherlands - these statements were made to the Criminal Police and are contained in the File!
But reality was the exact opposite. The Aortic Surgery Centre was merely one more issue on the common agenda of those responsible for the Hospital and the Faculty - among which the director of the Vascular Surgery department - which included, among other issues, the creation of an Advanced Simulation Centre and the promotion of the Lisbon Academic Medical Centre, which were, in fact, the reason for the trip to the Netherlands in the first quarter of 2014. There was a visit to the Simulation Laboratory in Eindhoven, as a first step towards a possible collaboration, and to the Maastricht University Medical Centre, where we were introduced to its organisational model, as well as to the structure of the Heart and Vessels Department, led by Prof. Michael Jacobs, a European reference centre for the conventional surgical treatment of complex diseases of the aorta and not for the use of endoprostheses.
A quick and simple investigation would have cleared everything up! How could such a huge evaluation mistake be made? And what would be the purpose? Those who suggested it in the statements contained in the file not only disrespected the investigating authorities but acted with unacceptable levity!
Furthermore, the File included other issues identified in the complaint as criminal acts (sic):
The criteria for material selection always privileged quality, suitability and safety, and then the individual preference of the different surgeons. This action also allowed the Board of Directors to renegotiate with the Industry, thus achieving a significant reduction in material costs, also in 2014.
Two concluding remarks.
The Institutions representing the Profession and the Inspecting, Supervisory, and Regulatory authorities also have to deserve the Trust of the Citizens and this requires competence, rigour and commitment from everyone, not only from Physicians. With regard to the mechanisms of Justice, they are still too slow, and when we are concerned, they seem like an eternity. But Justice worked, and proved to be worthy of the citizens' trust.
Much has been written on the Media lately. Serious, responsible, ethical and, above all, informed Information, is crucial in a truly free and democratic Society.
There is one obvious conclusion: neither the reality of the facts nor the results of the investigations confirmed the evidence. There is the need for stringent screening methodology, between the receipt of a complaint and the opening of public criminal investigation proceedings, which allows a strict assessment of the substance, grounds and veracity of the complaint.
And this failed in this exemplary story! Or...was there any other hidden interest?
Stimulating a reporting policy as a pillar of professional or political action is a process that requires, in addition to prudence and impartiality, two key requirements. First of all, the protection of the complainant's confidentiality in order to discourage cowardly anonymity. Secondly, the institutional ability to strictly investigate the authenticity and grounds of the complaint. As with everything in Life, there is a counterweight: the erosion of the institutional responsibility that has always been a pillar of good Governance.
The preservation of values, such as Freedom, the primacy of the Common Good, Democracy as a free expression of collective will, the independent and competent exercise of Justice and the right to good reputation and presumption of innocence, is also our responsibility as citizens. But as Physicians, the defence of Citizenship of the Sick Person, Humanity in the practice of Medicine and modernity in clinical practice, in accordance with scientific standards, are our moral and ethical imperative, and the essence of our professional oath.
The Precedence of Oath over the Duty of Obedience, as stated by Adriano Moreira with his recognised lucidity.
But it is in individual conscience and in respect for values that we must find the courage and strength to overcome this struggle.
In this exemplary story, it was a clear conscience and the sense of accomplishment that allowed overcoming such difficult moments and...keep going!
Physicians, Innovation and Responsibility - Facts and Lessons of an Exemplary Story
EDITORIAL
José Fernandes e Fernandes
The Convergence of Health Sciences with Engineering and the cooperation of physicians and researchers with industry, which transforms the product of research into new drugs or materials - devices - that can safely be used in humans, were decisive for the progress of Medicine. Its benefits have been recognised by the Community, from the eradication of some diseases and the cure of others to the improvement of survival with Quality of Life.
But, as with everything else, there is a counterweight we should not ignore.
Firstly, the cost of innovation which, reflected in the price of the end product, could jeopardise the sustainability of the Health Services and compromise key values such as Equity of access to Curative Medicine, which is an Asset, without economic and social discrimination and in a timely manner. Hence the need, in any process of adoption of therapeutic innovation, for two requirements: (i) careful selection of patients who could potentially benefit the most from it (ii) impartiality and independence of the professionals promoting it. This is the path that should be followed until this innovation dominates the clinical praxis and results in effective health and therapeutic advancement gains.
Secondly, there is a paradigm shift in the Medical Act, as a result of the multidisciplinary and multiprofessional cooperation indispensable in modern medicine, with an impact on the Physician's individual relationship with his/her Patient.
These realities add a new dimension to the Physician's Responsibility, as prescriber and user of the available clinical resources. They integrate the exercise of accountability, which is no more than the duty to do good and to be accountable. And the intelligent incorporation of medical progress and therapeutic innovation into everyday practice is part of this exercise. It is a dual Responsibility that involves the Physicians and the Authorities and should be complementary. For the former, it translates into the preparation of and compliance with clinical guidance standards for Best Practice – Guidelines - and, for the Authorities, into the creation of institutions focused on assessing therapeutic innovation, of which the NICE, in the United Kingdom, and the National Institute of Health (NIH), in the United States, were an example.
And this is a dimension of professional responsibility that I've always regarded as an undeniable duty, through a committed participation in the preparation of international Consensus Documents and Therapeutic Guidelines as part of the activity of the scientific societies in which I participated.
Public and media interest is natural; public scrutiny reinforces the need for the accountability and collective responsibility of all stakeholders.
In this context, the fact that there are complaints and legal proceedings against physicians arising from their clinical action, while fortunately rare in the overall context of clinical activity, has relevance and media impact, with negative repercussions on the public perception of Integrity and Professional Competence which affect the Citizen's Trust in Medicine and Physicians.
In our speciality - Angiology and Vascular Surgery - endovascular treatment was an innovation of the last decades of the 20th century that marked a new level of performance and changed our practice, just as laparoscopy, endoscopy, robotics and other technologies changed Surgery. It caused considerable controversy, especially in the treatment of aortic aneurysms, with committed detractors, but the discussion was open and scientific, as four realities emerged from it: i) Technological development in order to incorporate the recommendations of the professionals and correct the limitations of the initial prototypes - this was also the paradigm of the evolution of Surgery in the last 50 years! (ii) Demonstration of the feasibility and safety of the new procedure (iii) Outlining selection criteria and (iv) Need to assess its potential benefit over conventional treatment through appropriately controlled studies.
The collaboration of physicians, scientific societies, the industry producing these new materials and the Institutions was exemplary and enabled its current spectacular development. And, in recent therapeutic guidelines published by the European and the American Societies for Vascular Surgery (ESVS and SVS, respectively), the endovascular treatment of aortic aneurysms (EVAR) is considered the first therapeutic option provided that the patients meet the appropriate clinical and anatomical requirements.
Its story is well known; I will only recall facts relating to its introduction in Portugal. The first cases were performed by us in 1999 at the ICVL (Cardiovascular Institute of Lisbon). The experiment progressed, while allowing us to acquire expertise and to form a team. This technology was quickly adopted by most of the Portuguese Vascular Surgery departments. And, in Portugal, at the beginning of the second decade of the 21st century, endovascular treatment had also outweighed conventional surgery in the elective treatment of abdominal aortic aneurysm, as shown in a study presented at the SPACV Congress.
All these initial considerations are important to understand the exemplary story I refer to in the title, and upon which it is now possible to reflect. And, in my view, this reflection seemed indispensable, out of self-respect, respect for the Colleagues, for the Patients who trust us, and for human and modern Medicine, to which I have tried to be faithful as a physician, surgeon and scholar. But I also do it for a pedagogical and prophylactic reason, and to defend the precision and prudence required by these matters.
For me, this story began on 30/10/2015, when criminal investigation brigades were deployed for searches at my home and in both my public workplaces - the Santa Maria Hospital and the Faculty of Medicine - and my private workplaces - the Cardiovascular Institute and the British Hospital. Suspicions of improper practices in the selection and use of aortic endoprostheses and the proposal to create the Aortic Surgery Centre were the main evidence, together with the allegation that I was a doctor with enormous power due to the functions I performed and the knowledge I held! Those were the justifications presented in the document called Search and Seizure Warrant .
A few hours after the public launch of the investigations, the Media were addressing the subject, technically under legal confidentiality, extending its impact to a million-euro business and damages to the National Health Service, and showing my picture.
The Case ended on 18/1/2018 with an order from the Public Prosecutor's Office stating it was to be closed and clearing me of any illegal or irregular act. The full text of this order was published in the Justice Portal and I sent copies of it to the President of the Medical Association, the President of the SPACV for filing in the society of which I had been President, and also to the President of the Angiology and Vascular Surgery Specialty College, which I had also presided.
This Investigation Procedure was based on two components: the first one was an anonymous, handwritten complaint filed in April 2014 with the Inspectorate-General of Health Activities (IGAS). It was not investigated for a year - lack of means, was the explanation given to me -, but in April 2015 it was forwarded to the Public Prosecutor's Office. I was only heard by the IGAS in November 2015, i.e., 18 months after the complaint was received, and then I became aware of the full content of the handwritten document which supported it.
The second component was based on statements made to the Criminal Police by the former Clinical Director of the HSM-CHLN, of which we only became aware in 2017 - almost 2 years later - when we were allowed to access the File, one it was no longer under legal confidentiality.
Rereading the justification for the investigations is an instructive exercise. It allows assessing the solidity of the reasoning of the evidence gathered, counterweighted by the reality of the facts on which the suspicions and the final result of the investigations were constructed.
As for the anonymous complaint, a habit cultivated by the Doges of Venice - la bocca de la veritá, which served the preservation of Power better than the practice of Good Justice -, it became popular across societies of Mediterranean culture and beyond. But reporting is also an act of public responsibility, and whoever the author may be, he or she should not hide under the diaphanous veil of anonymity and cowardice! In an article published in the Público newspaper in November 2015, I mentioned the subject and clearly stated that I had recognised the complainant's handwriting.
An accurate, thorough and immediate investigation was required to prove the veracity of these accusations. First of all, out of respect for the Truth and, secondly, for the prestige of the Institutions where, at the time, I was holding management positions in the hospital service and in the medical school, but also for the honour of the Accused, which should be a paradigm in a democratic State supported by the Rule of Law. None of that happened. The IGAS's action did not preserve these objectives and did not even allow the investigation to be completed, with exemplary precision, while I was performing my public duties.
And this is the first lesson! The public responsibility of those who have the duty and the mission to ensure adequacy and integrity in the exercise of Health activities has unfortunately not been fulfilled and this is very serious and unsettling.
The Media transformed a case that was still under investigation into a public accusation, when no facts had been proven. They did not serve the fundamental right of Information, which is intended to be objective and impartial, and ignored another no less important right of every citizen: the right to Good Reputation and presumption of Innocence.
This is the second lesson. Responsibility and Accountability are also requirements for the Media - they are the indispensable counterweight to Freedom of Information. I recommend reading the article that has been recently published by Prof. António Barreto on The Information We Have, which should warrant particular attention.
However, in its essence, this Case substantiated two important issues. First of all, how to incorporate, albeit belatedly, a therapeutic innovation into a public service - in this case, the endovascular treatment of aortic aneurysm - which, in the future, can be any other clinical development. Secondly, the impartiality and independence in the selection of clinical materials, which should always, first and foremost, privilege quality, safety, and results.
In fact, the adoption of any new therapeutic modality, particularly in Surgery, follows demanding principles and rules, because it poses additional risks for patients, potentially dependent on the new technology and the experience of the performers. The desideratum is to minimise these risks, from the professionals' learning curve to the stringent selection of the new devices to be used, as well as to prevent conflicts of interest, illegal personal advantages, and act in an impartial manner. These issues are an exercise of shared responsibility, of the Physicians and Institutions in which they work, and must be addressed with precision, seriousness and continuous evaluation.
For all these reasons, it was crucial to ascertain whether all these rules had been neglected.
In October 2012, when I was appointed director of the Department, I clearly assumed, in the Action Plan submitted to the Board of Directors, the objective of promoting the incorporation of endovascular technology, which was indispensable in an academic department that had turned its back on innovation for too long, and advancing endovascular treatment, while preserving the skills acquired in conventional surgery and, thus, contribute to modernising the therapeutic action of the Department and the training of new Specialists.
This strategy had two pillars: the first one was an internal one, concerning the Department, and the second one was an institutional one, materialised in the rules set forth by the Board of Directors.
As for the former, under the responsibility of the Director of the Department, a decision coordination centre was informally set up, in order to ensure the proper selection of patients, of the materials to be used, and safety while performing the procedures, always involving the clinicians responsible for each patient. The aim was to optimise results, facilitate the learning curve of all the professionals, and ensure the conveyance of knowledge, as is the obligation of a public and academic service. This entire procedure was clear and participated: all the cases were then presented and discussed at the weekly operative scheduling meeting which was held on Thursday and on the day following their treatment, in the daily morning meeting of the Department to report all occurrences, a process that allowed constant monitoring of the activity underway. It had an indisputably formative value and was always based on impartiality and independence.
As for the institutional pillar, the policy followed by the two Boards of Directors while I was director of the department respected all medical decisions, but required a mechanism for their critical evaluation, forcing each case to be strictly justified. The methodology was as follows: i) Comprehensive clinical report of the patient's situation and the reasons selecting the endovascular treatment ii) Proposal of endoprosthesis to be used iii) Final approval by the Director of Department, and iv) Monitoring of the activity through the periodic evaluation of the indicators commonly used to evaluate clinical services, such as mortality rate, average hospital stay, percentage of rehospitalizations, comparison with the case-mix, which is an indicator of the complexity/difficulty of the patients that are treated, financial costs, which were included in the periodic reports prepared by the Board of Directors.
All the teams in the department were involved and were able to gain experience, as one could easily check in the Operating Room records and in the operative protocols, and the excellent therapeutic results were confirmed by the favourable developments in the aforementioned indicators.
All this could have been easily and quickly checked by the relevant authorities!
The strategy we followed was correct. In Clinical Medicine, and in an academic and public service, no one would ever be allowed to act alone, without support and guidance. Clinical management is an impartial, equitable, participated exercise of Responsibility, but this Responsibility is a privilege of the Hierarchy that is undertaken head-on and always in a pedagogical dimension. It is the undeclinable duty of those in charge. As is being accountable, a requirement that has always been fully fulfilled!
In December 2014, the lack of specifications and public tender for the acquisition of heart valves for the semi-invasive or percutaneous introduction of orthopaedic material and aortic endoprostheses was publicly criticised. Those responsible for the services in question immediately requested an audit to the Board of Directors of the HSM-CHLN, which, unfortunately, was never carried out in Vascular Surgery, despite my commitment and also that of the Chairman of the Board of Directors, who confirmed that he had forwarded the request.
Omission never serves the Truth! And that is the third lesson: the Institutions need to have swift mechanisms to respond and immediately clarify any doubts about the activities carried out by the services.
The other issue that, to my surprise, was relevant evidence for the investigation, as mentioned in the Search and Seizure Warrant, was the proposal to create the Aortic Surgery Centre. Its aim was to promote the centralisation of the rarer and more complex cases of aortic diseases, whose treatment requires specialised hospital resources, convergence of skills from various departments, and a multidisciplinary cooperation in an organised effort to optimise the evaluation and quality of treatment of these patients. I defended this operating model in several lectures in Portugal and abroad; it was also in line with the official policy of setting up Centres of Excellence for several rarer and/or more complex pathologies which, unfortunately, had not covered Vascular Surgery.
This proposal, whose logic was unassailable, was considered as evidence of collusion with the Chairman of the Board of Directors of the HSM-CHLN, as its purpose mistaken for the commercial exploitation of aortic endoprostheses, which would explain a trip to the Netherlands - these statements were made to the Criminal Police and are contained in the File!
But reality was the exact opposite. The Aortic Surgery Centre was merely one more issue on the common agenda of those responsible for the Hospital and the Faculty - among which the director of the Vascular Surgery department - which included, among other issues, the creation of an Advanced Simulation Centre and the promotion of the Lisbon Academic Medical Centre, which were, in fact, the reason for the trip to the Netherlands in the first quarter of 2014. There was a visit to the Simulation Laboratory in Eindhoven, as a first step towards a possible collaboration, and to the Maastricht University Medical Centre, where we were introduced to its organisational model, as well as to the structure of the Heart and Vessels Department, led by Prof. Michael Jacobs, a European reference centre for the conventional surgical treatment of complex diseases of the aorta and not for the use of endoprostheses.
A quick and simple investigation would have cleared everything up! How could such a huge evaluation mistake be made? And what would be the purpose? Those who suggested it in the statements contained in the file not only disrespected the investigating authorities but acted with unacceptable levity!
Furthermore, the File included other issues identified in the complaint as criminal acts (sic):
- i) Fitting of endoprosthesis in a 10-year-old patient with a traumatic rupture of the abdominal aorta, whose treatment was decided in a multidisciplinary meeting with the team of Paediatric Intensive Care and Paediatric Surgery team and was a success. Five years later, the endoprosthesis was dilated as planned, with excellent results, and today the patient is a healthy and active young woman.
- ii) Personal financial benefits from the use of aortic endoprostheses and from the Annual Angiology and Vascular Surgery Meetings I was organising since 1987, later called the Lisbon Vascular Forum, issues that were extensively investigated by the authorities. As clarified in the Filing Order, no irregularities, direct or indirect commercial connections with any medical or surgical products company, or personal or family financial benefit were found. As for the sponsorship of the scientific meeting, a common practice both in Portugal and abroad, no discrepancies or errors were found in the financial records, nor evidence of preferential support of any company or personal financial advantage.
The criteria for material selection always privileged quality, suitability and safety, and then the individual preference of the different surgeons. This action also allowed the Board of Directors to renegotiate with the Industry, thus achieving a significant reduction in material costs, also in 2014.
Two concluding remarks.
The Institutions representing the Profession and the Inspecting, Supervisory, and Regulatory authorities also have to deserve the Trust of the Citizens and this requires competence, rigour and commitment from everyone, not only from Physicians. With regard to the mechanisms of Justice, they are still too slow, and when we are concerned, they seem like an eternity. But Justice worked, and proved to be worthy of the citizens' trust.
Much has been written on the Media lately. Serious, responsible, ethical and, above all, informed Information, is crucial in a truly free and democratic Society.
There is one obvious conclusion: neither the reality of the facts nor the results of the investigations confirmed the evidence. There is the need for stringent screening methodology, between the receipt of a complaint and the opening of public criminal investigation proceedings, which allows a strict assessment of the substance, grounds and veracity of the complaint.
And this failed in this exemplary story! Or...was there any other hidden interest?
Stimulating a reporting policy as a pillar of professional or political action is a process that requires, in addition to prudence and impartiality, two key requirements. First of all, the protection of the complainant's confidentiality in order to discourage cowardly anonymity. Secondly, the institutional ability to strictly investigate the authenticity and grounds of the complaint. As with everything in Life, there is a counterweight: the erosion of the institutional responsibility that has always been a pillar of good Governance.
The preservation of values, such as Freedom, the primacy of the Common Good, Democracy as a free expression of collective will, the independent and competent exercise of Justice and the right to good reputation and presumption of innocence, is also our responsibility as citizens. But as Physicians, the defence of Citizenship of the Sick Person, Humanity in the practice of Medicine and modernity in clinical practice, in accordance with scientific standards, are our moral and ethical imperative, and the essence of our professional oath.
The Precedence of Oath over the Duty of Obedience, as stated by Adriano Moreira with his recognised lucidity.
But it is in individual conscience and in respect for values that we must find the courage and strength to overcome this struggle.
In this exemplary story, it was a clear conscience and the sense of accomplishment that allowed overcoming such difficult moments and...keep going!
