Organ donation scandal in Germany

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The organ donation scandal in Germany deals with alleged violations of guidelines by individual transplant centers in order to increase the likelihood of liver organs being given to patients in their own center who are waiting for a liver transplant . The full report of the Examination and Monitoring Commission of the German Medical Association (BÄK) can be viewed on the BÄK website. In detail, the brief statement of the report says in excerpts:

In 2010 and 2011, a total of 2303 post-mortem donated livers were transplanted in Germany.

  • The medical records of a total of 1180 recipients of post-mortem donated livers were examined in 24 transplant centers.
  • In the four transplant centers in Göttingen, Leipzig, Munich rechts der Isar and Münster, serious guideline violations of various degrees were found.
  • In Göttingen, based on the nature of the violations, the circumstances in the individual case and the frequency of occurrence, there was a suspicion of systematic or deliberate misstatements in favor of certain patients.
  • In Leipzig, Munich and Münster, too, there were clear indications of systematic incorrect information, even if in some cases to a lesser extent.
  • In 20 transplant centers, no guideline violations or only those guideline violations were found in which, due to the circumstances of the individual case or the low number, there was no suspicion of systematic or deliberate false information about the preference of certain patients (e.g. documentation errors, careless mistakes, assessment errors).
  • There were no indications that privately insured patients or so-called non-ET residents would have preferred treatment and transplantation.
  • The accelerated mediation process had reached 40% for liver donations. A careful examination of the circumstances has not been carried out. Which centers made use of it and to what extent has not been disclosed.
  • The waiting lists were not checked for eligibility. The number of patients who have been waiting for an organ has now halved, apart from patients with kidney disease.

In Berlin, Hamburg, Hanover, Magdeburg and Würzburg no violations of the guidelines were found (see p. 17 of the test report).

Individual clinics

University Medical Center Göttingen (UMG)

In Germany, the first chair specifically for liver transplants was established at the UMG in 1995 (Clinic for Hepatobiliary and Transplant Surgery). Like all other liver transplant centers in Germany, this UMG clinic was also internationally oriented. According to the legal situation at the time, patients from other European countries (so-called non-ET residents) for whom liver transplantation was indicated as the last treatment option could also be treated in the German transplant centers.

For organizational reasons, the chair at the UMG was closed in 2002 and the director of the clinic was appointed head physician at a large American clinic. However, liver transplantation was not given up at the UMG, but assigned as a functional area to the clinic for general, visceral and transplant surgery. Liver transplants were carried out there until 2015. Liver transplantation is an interdisciplinary task (transplant surgery, psychiatry, laboratory medicine, internal medicine, anesthesia and intensive medicine, radiology and pathology). Accordingly, it is necessary to bundle the information and control the processes. This was guaranteed at the UMG in the liver transplant outpatient department of the surgical clinic; the patient files were accordingly kept centrally here. There was also an independent staff unit with the transplant coordinator, directly assigned to the UMG board. The latter was used for process control via Eurotransplant and the German Foundation for Organ Transplantation (DSO).

In this respect, the liver transplantation at UMG was well organized when the accusation of data manipulation was first raised against the senior surgeon responsible for this in 2011. The UMG separated from him immediately after the allegations became known.

This surgeon was a "child of the first hour" in setting up liver transplantation at the UMG and was an assistant in the development phase of the chair established in 1995. His scientific investigations at that time remained the basis of later publications, even after he moved to the University Hospital Regensburg. Here they also formed the basis of his habilitation thesis. In 2008 he returned to the UMG as his old surgical and scientific place of work. As a senior physician, he was responsible for liver transplantation in the clinic for general, visceral and transplant surgery. In 2009, following the usual procedure, the president of the university was appointed to a professorship (temporary W2).

The manipulation allegations against him led to his being taken into custody in 2013 and charged with attempted manslaughter in 11 cases and bodily harm resulting in death in 3 cases. On May 6, 2015, he was acquitted by the Göttingen Regional Court , since in its opinion the manipulation would not be covered by these criminal offenses. The public prosecutor appealed to the Federal Court of Justice, which confirmed the acquittal on June 28, 2017. On September 13, 2019, the Regional Court of Braunschweig awarded him compensation of around 1.1 million euros and around 80,000 euros for deposit interest. The proceedings against other members of the UMG and a placement company were discontinued. The case against a patient was discontinued in exchange for a monetary contribution because of false statements in court about her alcohol consumption. According to the Braunschweig public prosecutor's office, there were no indications of bribery or any organ trafficking.

University Hospital Regensburg

According to the spokeswoman for the University Hospital Regensburg , patients from Jordan could also have been illegally placed on a waiting list for European transplant patients. The former head of transplantation at UMG was employed in Regensburg as a senior physician from 2003 to 2008 and is said to have entered into a cooperation with the Jordan Hospital in Amman in 2004 with the support of the Bavarian State Government . It is even suspected that a transplant recorded under Regensburg was carried out in Amman.

The director of the Clinic and Polyclinic for Surgery at the Regensburg University Hospital was temporarily on leave; the leave of absence was lifted in November 2012.

Hospital right the Isar

The BÄK's examination and monitoring commission identified 38 violations of the guidelines. In its final report, the commission headed by the Viennese surgeon Ferdinand Mühlbacher essentially confirms the already known violations of transplant guidelines at the Klinikum rechts der Isar . It comes to a total of 28. Mühlbacher sees three of them as having “criminal potency”. According to the report, they are "suspected of systematic or deliberate deception in favor of special patients". Specifically, blood samples are said to have been manipulated with urine. These cases are already being investigated by the public prosecutor. Above all, however, Mühlbacher pronounces a damning judgment on the organization of the liver transplant center at the Klinikum rechts der Isar. The department has "neither structure nor the right staff". In addition, the survival rates of the patients are too low. 70 percent survive the first year. According to the report, the European standard is over 80 percent.

Mühlbacher classifies the remaining 25 violations of guidelines as less serious, they can be explained partly by human error, partly by deficiencies in the regulations for transplants. Overall, however, there is a “lack of infrastructure” in the clinic and a “rather relaxed approach to existing regulations”.

With the manipulation of liver transplants at the Klinikum rechts der Isar , the number of transplants in particular should possibly be increased. The former head of the transplant center and head of nephrology fueled this suspicion. In an article in the specialist journal Dialyse aktuell he spoke about the background to the scandal in which the Klinikum rechts der Isar was involved:

“There has been much speculation about the reasons for this manipulation. It is clear, however, that one of the main motivations was the desire for more liver transplants. This was only possible by manipulating the waiting list, as Germany already had a low donation rate by international standards before this scandal. "

The clinic has already separated from its chief surgeon. The background to the planned separation from the professor are three cases in which blood samples were apparently contaminated with urine. Two of these blood adulterations from 2010 were already noticed then. The chief of surgery did not draw any conclusions from the events. In addition, a patient had a liver transplant in 2011, although experts who are currently reviewing the clinic's transplant program believe this was not necessary.

Science Minister Wolfgang Heubisch (FDP) and Health Minister Marcel Huber (CSU) announced at a press conference in mid-May 2013 the closure of the transplant programs in Erlangen and in the Munich Klinikum rechts der Isar of the Technical University of Munich.

Hospital of the University of Munich

The examiners of the German Medical Association also found seven guideline violations in liver transplants at the Großhadern Clinic . They came to the conclusion that in 2010 and 2011 four patients with liver cancer received a donor liver transplant there, although their cancer focus was still very small. The examiners judged this to be a clear violation of the guidelines for liver transplantation. In the case of the Großhadern patients, to whom both commissions are concerned, the diameter of the cancer foci was less than two centimeters. According to the examiners, the guidelines allow the allocation of a donor liver to cancer patients with a tumor only if it is between two and five centimeters in size. Only if several cancer foci have already formed in a patient, these may be smaller than two centimeters.

Three further manipulations at the Großhadern Clinic were not rated as serious violations of the guidelines.

University Hospital Leipzig

There were also 76 violations of guidelines for liver transplants at the Leipzig University Hospital . The clinic published this in January 2013. Data had been manipulated in 37 of the 182 patients who were transplanted with a donor liver in 2010 and 2011, said the medical director of the clinic, Wolfgang Fleig. Wolfgang Fleig has since been dismissed from his post by the supervisory board of the Leipzig University Hospital because of a broken relationship of trust.

At the end of June 2013, an investigation was opened against three doctors. The Leipzig public prosecutor's office investigated the suspicion of attempted manslaughter and dangerous bodily harm . The investigation should clarify whether patients were harmed or even died. No legal proceedings were opened due to insufficient suspicion.

University Hospital Münster

According to the information, there were a total of 25 guideline violations at the University Hospital Münster . a. also when specifying dialysis. The examiners doubted that there was an indication relevant for a transplant in all cases. The processes are "not yet finally assessed". The report of the German Medical Association describes this as follows: “During their reviews, the commissions found systematic violations of guidelines. Of the 30 patients who had been reported to Eurotransplant as requiring dialysis in 2010 and 2011, dialysis had not taken place at all in five cases or had been terminated prematurely without a resumption being possible or intended. In a further 9 cases, in the opinion of the commissions, there was no indication for dialysis, so that a dialysis report to Eurotransplant was not justified from the outset. Incidentally, this was also objectionable in the two cases in which a report to Eurotransplant should not have been made because the therapy had finally stopped. The submission of the necessary documents was extremely slow during the first visitations and was sometimes not even possible. This deficiency was remedied during the subsequent visitations. The necessary documents could be presented or submitted later. The visitations took place in a factual and concentrated atmosphere. ”(See p. 13 and 21 of the test report part 4).

University Hospital Essen

The handling of donor livers is criticized at the University Hospital Essen . A total of 15 guideline violations were found. The clinic accepts many low-quality organs that are rejected elsewhere because they are fatty or from elderly donors. This is one of the reasons why Essen has by far the highest number of liver transplants in Germany. Almost 17 percent of liver transplant recipients died in hospital there in 2011.

The guideline violations as systematic manipulations

Looking at the cases as a whole, it becomes clear that these are not individual acts, but rather a systematic manipulation within various German transplant centers. This is shown by the results of an interdisciplinary study by the University of Heidelberg, which was carried out between 2014 and 2016.

Overall, it becomes clear that the allegations of manipulation do not affect German transplant medicine across the board, but rather are limited to specific centers and specific transplant areas. In the testing period 2010–2012, the examination and monitoring committee found manipulations in 14 of the 51 German transplant centers. Violations of the guidelines were identified in the centers concerned in 369 of the 1010 cases examined. The average manipulation rate per affected center is therefore 40% of the cases examined. With regard to the affected organs, violations of guidelines were found in liver, heart and lung transplants, whereas kidney and pancreas transplants showed no violations.

With regard to the mechanisms that were effective behind the manipulation cases, the study shows that individual enrichment on the part of the doctors was of no importance. Rather, the incentives can be seen in the intrinsic logic of the medical profession and university medicine. Medical competition, the medical authority and the medical ethos of achieving the best possible treatment results were linked to rules of action that provided incentives for violations of the transplant guidelines.

Effects

The President of the German Transplant Society spoke out against organ trafficking and transplant tourism . This means patients who have never lived in Germany and only travel to the country to have a new organ transplanted and who have their address of a hotel or clinic put on the organ donation list.

Politicians from all parliamentary groups and the 2013 Federal Medical Association criticized the turnover-dependent salaries of senior physicians, so-called “chief physician bonuses”. The University Clinic in Göttingen drew conclusions: Since then, the amount of doctors' salaries is no longer linked to the number of transplants.

The Transplantation Act was modified several times in 2013 as a result of the events described; In addition to expanded state supervision of the transplantation system, a new criminal offense for future manipulation was created. A nationwide transplant register has existed since November 2016.

As a result of the scandal, the willingness of the population to donate has reached its lowest level since 2002. At the same time, around 12,000 patients are waiting for a donor organ.

A number of measures have been implemented by the German Medical Association , the German Hospital Association and the legislature to increase transparency, strengthen the supervisory bodies and avoid false incentives:

  • The Review and Monitoring Commissions have reviewed all centers with liver transplant programs.
  • All transplant centers will in future be unannounced on-site inspections at least once every three years.
  • Representatives of the federal states are involved in the tests in order to create a seamless flow of information to the responsible supervisory authorities.
  • In November 2012, an independent transplant medicine trust was set up to (also anonymously) report abnormalities against transplantation law.
  • The guidelines of the German Medical Association on waiting lists have been changed: A transplant conference decides on the acceptance on the waiting list, guaranteeing at least a six-eyes principle. The doctors responsible for this will be named to the Eurotransplant agency.
  • An expert opinion was commissioned to establish a national transplant register.
  • Waiting list manipulation will be punishable in the future and can be punished with a prison sentence of up to two years or a fine.
  • The guidelines of the German Medical Association on transplant medicine will in future be approved by the Federal Ministry of Health.
  • The allegations of manipulation concerned the area of ​​organ allocation, which in the German transplant system is strictly separated from the area of ​​organ donation. Nonetheless, the need was seen to strengthen state control in the area of ​​organ donation as well. The German Organ Transplantation Foundation, as the coordination center for organ donation, is therefore given a stronger focus on public law.
  • Bad incentives, such as bonus payments for transplants, should be avoided. In April 2013, the German Hospital Association and the German Medical Association therefore issued recommendations that ensure that financial incentives for individual operations cannot be agreed. This also applies to transplant medicine. This is to ensure the independence of the medical decision.
  • In future, hospitals will have to state in their quality reports whether they are complying with the recommendations of the German Hospital Association.

literature

  • Christina Berndt: Liver on offer. In: Süddeutsche Zeitung . 20th July 2012
  • Christina Berndt: For life and death. In: Süddeutsche Zeitung . August 20, 2013
  • Richard Fuchs: Death if necessary. The murder business with organ transplants. Ullstein, Frankfurt am Main / Berlin 1996, ISBN 3-548-36650-3 .
  • Nataly Bleuel, Christian Esser, Alena Schröder: A matter of the heart. Organ donation: when death saves lives. C. Bertelsmann, Munich 2017, ISBN 978-3-570-10109-4 .
  • Heike Haarhoff (Ed.): Organ failure. The crisis in transplant medicine in Germany. Hans Huber, Bern 2014, ISBN 978-3-943441-16-1 .
  • Andrea Hoisl u. a: Media assessments of the “transplant scandal”. Discourse analysis study on selected German newspapers. In: The anesthetist. Issue 1/2015, pp. 16-25.
  • Andrea Krenn (née Hoisl): Valuations of the “transplant scandal ” by the media. Med. Dissertation. Regensburg 2017.
  • Lisa Meyer: Health and Scandal. Organ donation and organ donation scandal in media reporting and interpersonal-public communication. Nomos, Baden-Baden 2017, ISBN 978-3-8487-3674-4 (Med.Diss., Erfurt 2016)
  • Eckart Roloff, Karin Henke-Wendt: Dubious transplants - does the shortage of organs tempt you to manipulate? In: Damaged instead of healed. Major German medical and pharmaceutical scandals. Hirzel, Stuttgart 2018, ISBN 978-3-7776-2763-2 .

Individual evidence

  1. ↑ bundesaerztekammer.de ( Memento from December 2, 2013 in the Internet Archive )
  2. ↑ a b bundesaerztekammer.de ( Memento from December 2, 2013 in the Internet Archive )
  3. ↑ Examination of liver transplant centers. (PDF) Examination Commission of the BÄK, August 9, 2018, accessed on August 9, 2018 .
  4. ↑ A. Obed, A. Beham, K. Püllman, H. Becker, H. Schlitt, T. Lorf: Patients without hepatocellular carcinoma progression after transarterial chemoembolisation benefit from liver transplantation. In: World J Gastroenterol. Volume 13, No. 5, 2007, pp. 761-767.
  5. ↑ A. Obed, T.-Y. Tsui, AA Schnitzbauer, M. Obed, HJ Schlitt, H. Becker, T. Lorf: Liver transplantation as curative approach for advanced hepatocellular carcinoma: is it justified? In: Langenbeck's archive Surg. Volume 393, 2008, pp. 141-147.
  6. ↑ T. Lorf, AA Schnitzbauer, SK Schäfers, MN Scherer, HJ Schlitt, M. Oellerich, H. Becker, A. Obed: prognostic value of the monoethylglycinexylididde (MEGX) -test prior to liver resection. In: Hepatogastroenterology. Volume 55, No. 82-83, 2008, pp. 539-543.
  7. ↑ File number 5 StR 20/16: HRRS 2017, 500-511. Stephan Ast: The manipulation of organ allocation. In: hrr-strafrecht.de. December 23, 2017. Retrieved December 24, 2017 .
  8. ↑ File number 7 O 3677/18: Helmut A. Graf: Senior doctor receives millions in compensation for illegal pre-trial detention. In: Graf-Detzer Rechtsanwälte PartG mbB. September 18, 2019, accessed December 7, 2019 .
  9. ↑ A lie for the lifesaver? Proceedings closed due to false testimony in the transplant process.
  10. ↑ a b Doctor remained undisturbed for years. Although Dr. O. was already noticed in the Regensburg University Hospital in 2005 ... In: Mittelbayerische Zeitung . August 2, 2012, accessed August 3, 2012 .
  11. ↑ The chief surgeon also falls into the twilight. (No longer available online.) In: Mittelbayerische Zeitung . August 7, 2012, formerly in the original ; Retrieved August 8, 2012 .  ( Page no longer available , search in web archives ) @1@ 2Template: Toter Link / www.mittelbayerische.de
  12. ↑ Organ donation scandal - the number of transplants is a mystery. (No longer available online.) In: br.de. Bayerischer Rundfunk , August 3, 2012, archived from the original on July 29, 2012 ; Retrieved August 3, 2012 .
  13. ↑ Uniklinik Regensburg cancels the leave of absence of clinic director Hans-Jürgen Schlitt. In: Wochenblatt Regensburg. November 21, 2012.
  14. ↑ Chief physician expresses serious suspicion. In: Süddeutsche Online. June 28, 2013.
  15. ↑ Organ donation scandal: the hospital separates from the chief physician. on: sueddeutsche.de , accessed on February 24, 2013.
  16. ↑ Defects at the LMU clinic. on: sueddeutsche.de , April 12, 2013.
  17. ↑ Anita Kecke and Mathias Wöbking: University Hospital Leipzig dismisses Wolfgang Fleig. In: lvz.de. Leipziger Volkszeitung, February 20, 2019, accessed on February 20, 2019 .
  18. ↑ Irregularities in liver transplants in Münster and Essen. In: Zeit Online . July, 1st 2013.
  19. ↑ OLG Dresden, decision of May 2, 2018, media information No. 17/2018
  20. ↑ New abnormalities. In: Süddeutsche Online . July, 1st 2013.
  21. ^ Abnormalities in liver transplantation. In: Süddeutsche Online. July, 1st 2013.
  22. ↑ Markus Pohlmann: The transplantation scandal in Germany: A social-scientific analysis of the background . Springer VS, 2018, ISBN 978-3-658-22784-5 , p. 155-159 .
  23. ↑ a b Markus Pohlmann , Kristina Höly: Manipulations in transplant medicine. A case of organizational deviance? In: Cologne journal for sociology and social psychiatry. 2017 (69), pp. 181-207, doi: 10.1007 / s11577-017-0436-3
  24. ↑ Organ donation scandal in Göttingen: "This requires criminal energy". In: Spiegel Online . Retrieved August 1, 2012.
  25. ↑ Broad front against chief physician bonuses. In: Doctors newspaper . January 28, 2013.
  26. ↑ Economization of Medicine: The Limits of the Market. In: Dtsch Arztebl. Volume 110, No. 23-24, 2013, pp. A-1134 / B-986 / C-982.
  27. ^ Transplantation Act: Renewed Amendment . In: Dtsch Arztebl. Volume 110, No. 25, 2013, pp. A-1239 / B-1081 / C-1073.
  28. ↑ Transplant medicine: Further legislative changes are pending. In: Dtsch Arztebl. Volume 110, No. 27-28, 2013, pp. A-1356 / B-1190 / C-1174.
  29. ^ Another amendment is being prepared in the Bundestag. aerzteblatt.de, June 25, 2013.
  30. ↑ Transplants 2013: The number of organ donors drops drastically. Spiegel Online , April 24, 2013.
  31. ↑ Report of the Federal Government on the progress of the reform processes initiated, possible grievances and other current developments in transplant medicine (PDF) BT-Drs. 18/3566 of December 12, 2014.
  32. ↑ Second report by the Federal Government on the progress of the reform processes that have been initiated, possible grievances and other current developments in transplant medicine (PDF) BT-Drs. Printed matter 18/7269 of January 11, 2016.
  33. ↑ Third report by the Federal Government on the progress of the reform processes that have been initiated, possible grievances and other current developments in transplant medicine (PDF) BT-Drs. Printed matter 18/10854 of January 13, 2017.