Ethics and Integrity of Governance: Perspectives Across Frontiers (New Horizons in Public Policy)

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However, concerns have been raised that the translation of basic research into workable therapies will be slow due to challenges related to regulation, reimbursement, and clinical adoption Gardner and Webster This has led to policy responses stressing translational research, i. Despite beliefs of the game-changing nature of regenerative medicine, and the subsequent economic benefits, there also exist a number of controversies around the ethical, legal, and social implications and how risks are controlled and regulated Allyse ; Hogle ; Horst Thus, regenerative is not only a fast-moving field but also highly contested.

Furthermore, examples of misconduct have been exposed in what was previously considered ground-breaking research, leading to retraction of articles in Nature Cyranoski Hence, studying the issues related to governance of intended interactions is especially pertinent for regenerative medicine, given the fast pace, ethical considerations, risk regulation and the close connection between research and health-care practice.

In order to understand the process of governance of intended interaction in regenerative medicine, we will follow the interaction among the main actors around a specific research center established to promote the translation of research in regenerative medicine into clinical practice. The case study is organized through our theoretical framework, using the concepts of collective action, resource pool, and governance. The time frame of —16 is set by the events leading to the recruitment of Macchiarini by KI and the KUH in December , his joint tenure up until October , when his contract with KUH was not renewed, and up until his dismissal by KI in March The case study is based upon archival and electronic documentation related to the crisis described in Section 2.

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Due to the nature of the crisis, all parties have an interest in putting forward their own particular interpretation of the sequence of events. We have had three main methods to deal with it. One is to apply the basic idea of critical reflection of sources—who said it, why and what interest did they have in this interpretation. A second has been to use the popular press to build a structure of events, which can then be confirmed or discarded when we look the original sources. A third has been to try to find repeated accounts of similar events, known as triangulation by using multiple sources to check statements, as detailed below.

A variety of sources have been used and compared to each other. The majority of documents and websites are in Swedish and the authors have translated the content into English where appropriate. Due to open access laws in Sweden for public authorities like universities and research councils, the majority of documents can be assessed. However, a starting point is often needed, such as an organization, an event or decision or a name of a person involved.

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Hence, the extensive public press, such as blogs and newspaper articles, has been useful to track down such information, and in turn find the original documents. Thus, we have collected and analyzed a wide range of sources including documents from foundations and financers, reports from KI, reports from investigations, official statements and press releases, unofficial viewpoints blogs from persons mentioned by name in the processes, scientific journal articles, websites, and reports in trade medical press.

Moreover, KI has been active in social media, providing their perspective of the sequence of events, as documented on their website Karolinska Institute b. Recent reports from the various investigations have also been used, e. The case description is organized in three sections. Section 4. Finally, section 4. Therefore, this subsection focuses upon the goals, imperatives and funding of the government and KI, and how this led to the creation of the ACTREM center.

Instead of increasing the total funding to universities, the government identified a few research field, and only researchers in those fields could compete for SRAs. According to the Swedish Government Bill, a SRA should fulfill the following criteria: 1 Research that has the potential to be of highest international quality in the long term; 2 Research that can help address large societal needs and solve important problems in society; and 3 Research that is within an area that is important for Swedish businesses.

Hence, these SRAs should help make Sweden internationally competitive as well as produce the highest international excellence in science Swedish Executive Government For the total SRA policy initiative, the government made an investment between and of a total of million EUR, and twenty centers were financed, through five funding agencies, 1 and the Swedish Research Council took the lead in medicine.

We estimate that this program received around 3 million EUR per year from to from SRAs, for a total of around So why did KI want to develop research in regenerative medicine and recruit star scientists?

Ethics and Integrity of Governance: Perspectives Across Frontiers (New Horizons in Public Policy)

They specified the aim to be world-leading in stem cells and regenerative medicine, although at the time, they did not have so much on the translational research, especially the clinical side. The StratRegen program was used as a platform to obtain a number of large grants in regenerative medicine from various sources—including starting seven different research centers.

Some centers are funded by private foundations such as the Knut and Alice Wallenberg foundation, some by public money such as the regional health authority and some by traditional research financers. Macchiarini and Birchall were called stars and super-stars of regenerative medicine. When KI recruited Macchiarini as a visiting professor in December , he was also employed part time as consultant and surgeon at the KUH.

During —14 Macchiarini was awarded grants for research and clinical development, for a total of 1. KI reports many activities related to regenerative medicine which we interpret as building up a common resource pool: recruiting leading international scientists; developing the most modern equipment for research; support leading younger scientists; expanding a set of laboratories that specialize in techniques that are very complicated, and therefore cannot be mastered by individual research groups. Moreover, KI stresses in these reports that it is the Institute which has published and done the synthetic trachea, and not only Macchiarini.

This is strongly stated in their report:. When looking back to , we are happy to report several scientific landmark discoveries at the Karolinska Institute that have been published in leading scientific journals and also highlighted in media around the world. One such example is the first transplantation of an upper airway trachea to a patient that suffered from a tumor in the airways that could not be surgically removed without replacing the upper airways.

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The new airway was made of synthetic material coated with the patient's own cells, so it would not be rejected after transplantation. This breakthrough was spearheaded by Professor Paolo Macchiarini, but was also based on a true collaboration by a number of research groups at the Karolinska Institute, ranging from molecular biologists to surgeons and transplantation immunologists. Swedish Research Council However, this scientific landmark made by Macchiarini and his collaborators at KI and KUH soon becomes heavily criticized, both among his collaborators, in the wider research community, and in public.

This section addresses the hiring and initial expectations and successes of the new KI visiting professor.

Hence, we interpret that his primary role would be translational research connecting bioscience and clinical medicine as reflected by his dual appointment by KI and KUH. The trachea windpipe implants operations carried out between KI and KUH were the first of their kind, world-wide.

They were a continuation from previous operations that Macchiarini had performed in and , where stem cells were used and said to be growing on a human scaffold e. However, the operations at KI involved a synthetic scaffold e. A synthetic scaffold should be used, because the research activities and goals of ACTREM were to integrate tissue engineering, using biological or synthetic scaffolds, with cell therapy, pharmaceutical therapy, and cells biology Karolinska Institute Integrating these fields required interaction with private actors, to obtain the synthetic scaffolds.

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Moreover, the clinical side was quite important, as indicative by the distribution of scientific publications at the time, with many involving clinical procedures. Three patients underwent operations in Sweden, and all came from abroad. In November , a second cancer patient received a synthetic trachea after having himself approached Macchiarini. This time the patient came from Maryland, USA. The third patient, a women from Turkey was referred to KUH by her Turkish doctor, and she received a synthetic trachea in August and was re-operated in July following severe complications. The first patient died in January , 30 months after the operation.

The second patient died in March , less than 4 months after the operation. The third patient was still a live as of May , 22 months after the re-operation, but was receiving intensive care at KUH in late Gerdin Other reports, including the Swedish documentary, mention additional transplant operations outside Sweden 9. The details of the setting of these operations have much impact on interpreting later events. Despite that, the operation of these patients later became a subject of research publications describing the implantation and its outcome.

The equipment and the scaffold are considered relatively simple medical devices, but once a scaffold becomes seeded with stem cells it is classified, for regulatory purposes, as a pharmaceutical for advanced therapy. The use of such pharmaceuticals on human subjects requires approval of the Swedish Medical Products Agency, and such an approval was not obtained before the operations Asplund Moreover, the scaffolds and specialized equipment needed for seeding and growing the stem cells were obtained outside KUH and KI.

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The bioreactor used for seeding and growing the stem cells on the synthetic scaffold was provided by a German subsidiary of Harvard Bioscience Hugo Sachs ; Jungebluth It was a further development of the bioreactor used by Macchiarini in The scaffold provided by Harvard Bioscience was of different construction compared to the one provided by UCL.

Instead of a porous solid construction it was a fiber construction HART Through this cooperation with Macchiarini, Harvard Bioscience intended to develop and market the InBreath Airway Transplant System including a synthetic scaffold and a bioreactor. The company had acquired the property rights to the bioreactor design before the first KUH operation. The initial responses to the operations with synthetic trachea transplant at KUH were extremely positive, both in the scientific press and in mass media. However, soon after the publication of the Lancet article critical voices emerged.

The initial criticism started much earlier. Even though the first trachea implant made in was hailed as successful and published as clinically successful, it became apparent to physicians at KUH that the implants were not working as well as reported the paper. The stem cells had not grown to reconstruct the trachea.

Furthermore, physicians at KUH invested much effort to attend to the critical condition of the third patient, following the operation. In June , 5 months after the death of the first patient implanted with the synthetic trachea, four physicians jointly employed by KI and KUH filed a formal complaint at KI. Furthermore, they point out a failure to obtain proper consent from patients, as well as failure to obtain ethical permission from the Regional Ethical Board Gerdin ; Karolinska Institute b. In Sweden, universities monitor the conduct of their researchers, and not a national board.

Hence, the university internal Ethics Council investigates and makes decisions about matters of plagiarism, fraud, misrepresentation of data, misrepresentation of research processes, and other types of scientific misconduct. Furthermore, if a formal complaint is filed, an investigation is required and should result in a formal response by the university. Therefore, KI responded to the formal complaints, as required, with an internal investigation.

In the Ethics Council and the Vice-Chancellor freed Macchiarini of suspicions of research misconduct. An external examiner, appointed in , had come to different conclusions, but his conclusions were seen as input to the KI internal process rather than binding recommendations Gerdin ; Hamsten and Samuelsson a ,b.

The magnitude of the crisis for the governance systems of medical research and innovation can be understood through the subsequent investigations after the TV documentary and public outcry. By February , 1 month after the airing of the documentary, fourteen separate investigations were started in Sweden Karolinska Institute e.

Six of these investigations focused on procedures for handling investigations about scientific misconduct, and of these, five investigated the internal processes at KI. They covered issues ranging from their internal handling of the allegations of scientific misconduct fraud , the details of the recruitment process, the reporting of extra-mural occupations, and also the delegation of responsibility between different actors in Sweden and within KI and KUH.