It’s been almost a year since ORGANize, a venture capital & investment banker backed group that is targeting nonprofit Organ Procurement Organizations (OPO), publicly implicated the Kentucky Organ Donor Affiliate (now part of Network for Hope) in misconduct, for following a hospital MD’s diagnosis and honoring a family’s decision to donate organs upon his death.

ORGANize has repeatedly said that the OPO came close to recovering organs from a living patient. In reality the OPO never started recovery procedures because OPOs only recover organs from patients that hospital MDs declare dead.

How has misreporting of this sensationalized incident affected patients waiting for organ donation and transplantation? Has it had any impact on the Centers for Medicare & Medicaid Services’ Final Rule for OPOs? Science in Donation and Transplantation assesses the current state of affairs: 

Much of the news media continues to report this story as if it is a settled fact, but the reporting was grossly inaccurate from the beginning. The story was that the patient had been declared brain dead after a drug overdose but woke up en route to the OR for organ recovery and said, “No”. That was the impression ORGANize co-founder Greg Segal left with members of the House Energy and Commerce oversight subcommittee last September. But Segal’s version of the story and the media’s echoing of it runs counter to what we have learned of this case from the OPO, staff, and reviewers

The patient was not a Donation after Brain Death (DBD) donor, but Donation after Circulatory Death (DCD) donor. All DCD donors are brought to the OR area for possible donation after they have been determined by the hospital’s MD to be terminal and families agree to donate organs. He was never declared “brain dead” by the medical team treating him at a local hospital.

Here’s the sequence of events for a potential DCD donor:

• The doctor tells the family that there is little chance the patient will recover

• The family decides to withdraw care 

• The hospital notifies the OPO there is a potential DCD donor

• The OPO looks at the donor registry and informs the family that their loved one is a donor; or gets consent from next of kin and does a medical social history

• The patient goes to the operating room alive

• The patient’s ventilator is removed. If the heart stops beating within 60-75 minutes and if five minutes pass with no heartbeat, the hospital MD declares the patient dead

• If the heart does not stop beating in this timeframe, the organ donation is cancelled, and the patient is allowed to pass peacefully in subsequent hours or transferred to longer term care.

• Transplant surgeons enter the operating room to recover organs for donation only after the declaration of death.

Contrast that with what the news media has been saying about the KODA case, prompted by ORGANize:

The Guardian:

A man who had gone into cardiac arrest and been declared brain dead woke up as surgeons in his home state of Kentucky were in the middle of harvesting his organs for donation, his family has told media outlets.

LEX18 (NBC affiliate, Lexington KY):

Donna Rhorer says her brother, TJ Hoover, was declared brain dead after suffering an overdose in October 2021, but she says doctors attempted to harvest his organs while he was still showing signs of life.

NPR:

"He was moving around — kind of thrashing. Like, moving, thrashing around on the bed," (Natasha) Miller told NPR in an interview. "And then when we went over there, you could see he had tears coming down. He was crying visibly."

The donor's condition alarmed everyone in the operating room at Baptist Health hospital in Richmond, Ky., including the two doctors, who refused to participate in the organ retrieval, she says.

The New York Times:

The investigation criticized Kentucky Organ Donor Affiliates, which was coordinating donations in the state. Now called Network for Hope after a merger, it has said it always follows the rules and never removes organs until a hospital has declared a patient dead.

But the investigation found that the organization’s employees repeatedly pressured families to authorize donation, improperly took over cases from doctors and tried to push hospital staff to remove life support and allow for surgery even if there were indications of growing awareness in patients.

No matter how zealous a given OPO’s team might be about securing organs from a potential donor, until they are declared dead, they are bystanders, working behind the scenes to be ready in the event organ donation can happen and patients on the transplant waiting list can be helped. In turn, the hospital’s medical team is completely focused on achieving the best possible outcome for their patient, who remains their patient as long as they are alive.

A 2019 survey found that organ donation and transplantation enjoyed 90% approval from the American public, a rarified level of support shared only with the National Park System, seatbelts and police being forced to wear body cameras. 2019 was also the year of the first successful adult heart transplant using a DCD donor, a development that was broadly welcomed because of the potential to “expand the donor pool, resulting in increased transplant volume and decreased waitlist times,” according to a paper published by the American College of Cardiology.

But now, organ donation and transplantation are on the defensive. In the wake of the sensationalized Kentucky stories, HHS Secretary Robert F. Kennedy Jr. demanded an overhaul of organ donation and transplantation, saying “the entire system must be fixed to ensure that every potential donor’s life is treated with the sanctity it deserves.”

The worst outcome from ORGANize’s successful disinformation campaign is what the Association of Organ Procurement Organizations (AOPO) now reports: Thousands of Americans who had registered as organ donors have removed themselves from the list. AOPO also reported that the pace of transplantation had slowed, putting the nation’s streak of setting a new record for transplants every year at risk

At the time of the subcommittee hearing, the Final Rule appeared to be in trouble. Every few weeks through the summer of 2024, the scientific community published a new paper showing the Final Rule was based on marginal data that would produce biased and unreliable results while forcing up to 70% of OPOs to close. Things got so bad for the Final Rule’s reputation that HRSA forced academics to take down six papers critiquing it from the American Transplant Conference, leading to accusations of “censorship.”

But now, a year later, the media and Congress are only focused on the fallout from the still-unresolved Kentucky story. More papers have been published showing the Final Rule’s fatal flaws, but the media prefers the horror fiction of a man waking up as his organs are being removed.

ORGANize distorts how DCD donations are conducted to make the process appear to be a threat to patients. But it has come at a steep cost in the public’s lost faith in the system. The list of those who need organs continues to grow, but unless the de-registration trend is reversed, there will be fewer organs available when they are most needed. ORGANize’s disinformation costs patients their lives.

Science in Donation and Transplant has known for years that ORGANize was reckless and willing to bend the truth to advance its agenda. But this episode has shown its callousness – throwing patients under the bus for the sake of their PR strategy. It will take years to undo the damage.