Ashley Baquero1, David H Beyda2, Maria Fiatarone Singh3, Glynn Gilcrease4, Joseph E Gutierrez5, Jacob Lavee6, David Matas7, Norbert Paul8, Bernadette Richards9, Matthew P Robertson10, Wendy Rogers11, Raymond Scalettar12, Michael Shapiro13, Adnan Sharif14, Alexander H Toledo15, Torsten Trey16. 1. Dominican Transplant Institute, Santo, Domingo, Dominican Republic. 2. University of Arizona College of Medicine, Phoenix, Arizona. 3. University of Sydney, Sydney, Australia. 4. University of Utah School of Medicine, Salt, Lake City, Utah. 5. Private Capacity. 6. Sheba Medical Center/Tel Aviv University, Ramat Gan, Israel. 7. The International Coalition to End Transplant Abuse in China. 8. University Medical Center of Johannes, Gutenberg, University of Mainz, Mainz, Germany. 9. University of Adelaide, Adelaide, Australia. 10. Australian National University, Canberra, Australia. 11. Macquarie University, Sydney, Australia. 12. George Washington University Medical, Center, Washington, DC. 13. Rutgers New Jersey Medical School, Newark, New Jersey. 14. Queen Elizabeth Hospital, Birmingham, Birmingham, UK. 15. University of North Carolina, at Chapel Hill, Chapel Hill, North Carolina. 16. Doctors Against Forced Organ Harvesting, Washington, D.C.
To the Editor:The Annals of Surgery has recently accepted a paper for publication titled “Lung Transplantation for Elderly Patients With End-stage COVID–19 Pneumonia” authored by Dr. Han Weili et al.We are surprised that this article was accepted for a number of reasons. Although COVID–19 is an urgent medical subject, we believe it should not result in lowering requirements of authors and bypassing ethical standards. Quality of academic submissions, due process in medical research, and clearly defined ethical considerations must not be sidelined despite the urgency the medical profession is facing. COVID–19 must not be accepted as a reason to normalize unethical practices.The paper raises serious ethical concerns regarding organ procurement and publication standards. First, given the ongoing concerns about organ procurement in China, the time frame of these transplants is concerning. Matched lungs were obtained in 4 days for the first case, and 3 days for the second. In comparison, the median wait time for lung transplants in the US is nationwide 94 days, while even in leading lung transplant centers the wait time is 15 days (see Fig. 1).
The US has an established public organ donation program that is over 75 times the size of the Chinese equivalent when measured by number of registered donors.
In contrast, the Chinese volunteer system is relatively new, and there are ongoing and credible doubts about the figures provided about the organs sourced from volunteers,
leading to grave concerns about organ sources in China. The authors do not mention whether the donors provided free, voluntary consent and do not claim that no organs from prisoners were used. Indeed, even such promises are not guarantees that the organs were in fact ethically sourced — in several cases, surgeons in the People's Republic of China who have made such claims have been unable to substantiate them when pressed by journal editors for further information.
Due to the lack of transparency surrounding the China Organ Transplant Response System (COTRS), the authors’ statement that “Donor lungs were acquired by COTRS protocol” is not sufficient to establish whether internationally established ethical standards were followed. There are also concerns about consent on the part of the recipients, as only in 1 case were family members stated as having given consent to perform the transplant Figure 1.
FIGURE 1
Median wait time for lung transplants (in days).
Median wait time for lung transplants (in days).Second, the recipients’ ages (66 and 70 years) raises questions about the probity of the organ allocation system in China — if the organs were in fact allocated via COTRS at all. It is hard to understand why 2 elderly patients with severe morbidity and a low likelihood of survival would be moved to the top of the transplant registry. We are concerned that these transplants may have been procured from nonvoluntary donors and performed to secure “world first” publications on lung transplants in COVID–19 patients, as emphasized by Chinese state media reports,
rather than in accordance with an equitable organ allocation system.Third, the article does not report outcomes for the patients beyond day 5 (patient 1) and day 3 (patient 2). Although the authors state “Lung transplantation was the only way to save their lives,” they fail to report whether they succeeded in their objective. Thus, there are no data in the paper to support the conclusion that “Our experience shows that lung transplantation could be an effective choice for end-stage COVID–19 patients.” Instead, readers are left wondering whether the transplants were unregulated experimentation.The lack of outcomes data in the paper undermines the case for publication. It is possible that in some cases, urgent publication of Chinese transplant research may be permitted
but this paper does not make an important contribution to the literature as it lacks outcome data, and lacks any account of the sources of the organs.For these reasons we respectfully request that you consider retracting the paper. The ethical standards and validity of the research fall far below what readers expect from a journal of the standing of the Annals of Surgery.
FIGURE 1