Liver Transplant Studies Retracted Over Organ Harvesting Concerns

 Two Chinese studies related to liver transplantation published more than a decade ago in the Journal of Hepatology were retracted by the journal's editors.

The editors said concerns were raised that the transplants described in both studies may have involved organs "procured unethically."

The first study -- "Association between donor and recipient TCF7L2 gene polymorphisms and the risk of new-onset diabetes mellitus after liver transplantation in a Han Chinese population" -- was published in October 2012 and retracted this week. In the retraction notice, the editors said they had asked the study's authors to:

• Provide evidence of ethical approval from an appropriate Institutional Review Board that pre-dated the start of the research
• Provide evidence of the source of donor organs and confirmation that they were obtained with informed consent and not from executed prisoners or trafficked individuals
• Confirm whether the research involved organs from living or deceased donors
• Clarify whether the study complied with relevant international standards

In the retraction notice for the second study, "Safe use of liver grafts from hepatitis B surface antigen positive donors in liver transplantation," which was published in October 2014 and retracted last month, the editors said they asked for similar documentation.

In both cases, the authors failed to provide the necessary documents or meet the evidentiary requirements in guidance from the Committee on Publication Ethics or the organ provenance policy from Elsevier, which publishes the Journal of Hepatology.

"The journal is strongly against the use of human organs or tissues from any individual where appropriate consent has not been obtained," the editors wrote. "Given that the editor has outstanding concerns regarding insufficient documentation of ethical organ provenance and appropriate ethical approval, they have made the decision to retract the article in accordance with Elsevier policies."

The retraction notices directly referenced a review article published in BMJ Open in 2019, in which researchers led by Wendy Rogers, PhD, of Macquarie University in Sydney, Australia, called for the mass retraction of 445 scientific papers on organ transplantation published in 173 journals -- including the two studies retracted by the Journal of Hepatology -- over fears that the organs were obtained unethically from Chinese prisoners, "pending investigation of individual papers."

Last year, Retraction Watch published an article describing how journals have been slow to "clear the record," despite a number of new retractions.

In an email to MedPage Today, Rogers noted that Elsevier's research ethics policy states that the source of organs or tissues used in research "must be transparent and traceable and must not be sourced from executed prisoners or prisoners of conscience, consistent with recommendations" from the not-for-profit Global Rights Compliance (GRC).

"We've been contacting journals with the GRC advice and this is triggering a new round of retractions," Rogers said.

Meanwhile, allegations persist that China continues to unethically harvest organs for transplant, despite an announcement in 2015 that it had banned the use of prisoners' organs as the major source of organ donations.

"We have no evidence China has stopped forced organ harvesting," Rogers pointed out. "There continue to be high numbers of transplants with significant doubt that the voluntary system can supply enough organs."

In 2019, a tribunal initiated by the International Coalition to End Transplant Abuse in China ruled that evidence suggests the practice has not stopped.

The International Society for Heart and Lung Transplantation issued a statement in 2022 on transplant ethics, noting that it was boycotting studies relating to transplantation that involve organs or tissue sourced from China, given "the body of evidence that the government of the People's Republic of China stands alone in continuing to systematically support the procurement of organs or tissue from executed prisoners."

Various U.S. congressional committees have held hearings on the subject. Last year, Rep. Chris Smith (R-N.J.) introduced the Stop Forced Organ Harvesting Act, which was passed in the House by a vote of 406-1, but stalled in the Senate.

Earlier this year, Sens. Ted Cruz (R-Texas) and Jeff Merkley (D-Ore.) introduced a separate but related bill -- the Falun Gong and Victims of Forced Organ Harvesting Protection Act -- which would impose sanctions on those responsible for organ harvesting in China and directs the Secretary of State to report to Congress on the Chinese organ harvesting policies and transplant system.

https://www.medpagetoday.com/gastroenterology/livertransplantation/122124