HHS Secretary Robert F. Kennedy announced a move to tighten oversight of the practice of removing vital organs from neurologically impaired patients.
In a July 21 news release, Kennedy announced a “major initiative” toward reforming the organ transplant system.
“Our findings show that hospitals allowed the organ procurement process to begin when patients showed signs of life, and this is horrifying,” said Kennedy. “The organ procurement organizations that coordinate access to transplants will be held accountable. The entire system must be fixed to ensure that every potential donor’s life is treated with the sanctity it deserves.”
Controversial Case Reopened
On May 28, the Health Resources and Services Administration (HRSA) sent a letter to the federally funded Organ Procurement and Transplantation Network (OPTN) mentioning the reopening of an investigation into what is believed to be the 2021 case of Anthony Thomas Hoover in Kentucky, who was declared “brain-dead” but woke up thrashing and crying one hour before doctors were about to remove vital organs. Under the Biden administration, OPTN, which serves Ohio and Kentucky, closed the case without taking action.
Kentucky Attorney General Russell Coleman is also investigating the case, and the U.S. House Oversight and Investigations Subcommittee held a hearing on organ procurement last fall.
More and more hospitals are declaring patients “brain dead” even though their circulation systems are still functioning. Organ transplantation has been a lucrative business for hospitals, with a heart transplant generating an average of $ 1.664,800 in billable charges, according to Millman, a consulting firm.
Threat of Decertification
The reopened investigation by HRSA found 351 cases where organ donation was scheduled but not completed. About one-third (29.3 percent) showed “concerning features,” including 73 patients with “neurological signs incompatible with organ donation,” and at least 28 patients who may not have been deceased at the time of organ procurement, “raising serious ethical and legal questions,” states the HHS news release.
The investigators also found “poor neurologic assessments, lack of coordination with medical teams, questionable consent practices, and misclassification of causes of death, particularly in overdose cases.”
Kennedy wants all “safety-related stoppages” of organ harvesting by families of loved ones to be reported to regulators, and he said he will decertify OPTN if it fails to take corrective measures.
Congressional Investigation
Meanwhile, the U.S. House Committee on Energy and Commerce is examining ethical breaches in organ transplantation and considering reforms. Heidi Klessig, M.D., author of The Brain Death Fallacy, sent the committee a letter with 300 signatures of doctors, nurses, philosophers, lawyers, and private citizens in support of reform.
The letter points out that a “brain death” diagnosis does not always comply with The Uniform Determination of Death Act (UDDA), a model state law, that requires “irreversible cessation of all functions of the entire brain, including the brain stem.
Hospitals may also fail to inform families that patients can survive so-called “circulatory death,” beyond the two-to-four-minute window that can be used. Hospitals also use a controversial practice known as “Normothermic Regional Perfusion,” where doctors clamp off circulation to the brain after full resuscitation, playing “fast and loose with the legal definitions of death under the UDDA as well as with the dead donor rule.”
Patient Option
Although Klessig says she is encouraged by the HHS and congressional action, getting reform could be a “difficult moral, medical, and legal knot to untangle.” Klessig supports three changes.
“First, full transparency about how death is declared prior to organ and tissue procurement, for without transparency there is no true consent,” said Klessig.
States should also offer an “opt out” exemption for a “brain death” declaration.
“There are eight states with medical freedom legislation that allow health care providers to opt out of participating in a brain death case, but the only state where patients have this right is New Jersey,” said Klessig. “And New Jersey’s law only provides for a religious exemption. People should be able to opt out for any reason.”
Also, laws should “mandate that informed consent be obtained before embarking on a brain death diagnosis, which includes the dangerous apnea test that can make a brain injury worse and has risks of hypotension, pneumothorax, and cardiac arrest,” said Klessig.
Information Deficit
More public awareness and “some recourse for family members who think their loved one might still have a chance” are necessary for true informed consent, says Jane Orient, M.D., executive director of the Association of American Physicians and Surgeons.
“The organ procurement industry is powerful, and there is a lot of money in transplants,” said Orient. “I believe a lot of corners are being cut. There are a significant number of cases of would-be donors who survived, but there is a widespread perception that survivors will be ‘vegetables’ or have a life not worthy of life.”
There is also an ethical concern for anesthesiologists before organ removal.
“Why anesthetize a person declared dead, but if they don’t, they may see blood pressure responses like with pain,” said Orient. “This means that some part of the brain must be functioning. Once you deny the sanctity of life and accept human sacrifice, there are moral and legal dilemmas.”
Ethical Alternative
Vital organs such as the heart or lungs require some blood circulation before they can be successfully transplanted into another patient. There is a better approach, says Klessig, a so-called “living donation.”
“Both the donor and the recipient remain alive after the procedure,” said Klessig. “It is completely ethical and can provide every organ except the heart.”
More trials are underway for implantable artificial hearts, which eliminate the need for human donors, says Klessig.
“I am hoping that greater transparency will actually lead to more lifesaving transplants, not less,” said Klessig. “After all, brain death accounts for less than 1 percent of deaths nationwide, whereas the number of living donors is potentially vast.”
AnneMarie Schieber ([email protected]) is the managing editor of Health Care News.
