“And Death Shall Be No More”

Author

Craig Klugman

Publish date

Tag(s): Legacy post
Topic(s): Clinical Trials & Studies Human Subjects Research & IRBs Informed Consent Social Justice

by Craig Klugman, Ph.D.

Two years after John Donne’s death, the Holy Sonnets were published. In Sonnet 10, Donne speaks about the end of death: “Death, thou shalt die.” Although a metaphorical conceit referring to eternal life in heaven, the poem takes on new meaning in the age of regenerative medicine.

Since the 1968 ad hoc Harvard committee on defining death, brain death has been defined as the “irreversible loss of all functions of the brain, including the brainstem.” If a new project is successful that definition may have to be revised or deleted.

Bioquark (US) and Revita Life Sciences (India) have received human subjects approval from the NIH to reverse brain death and regenerate the brains of 20 patients. As the Revita website says, “Dead Man Walking. US-INDIA Project could revive brain dead patients. A team of doctors from India and the US are working on an ambitious project to infuse life into those deemed brain dead. The Multi-Modality Approach to reverse braindeath [sic] could be the path to a medical break through.” The public misunderstanding about brain death (that it is indeed death) has entered a new realm where the smell of potential profit is using science to prove misconceptions or that the companies are taking advantage of unfounded hope that life does not have to end (millions of years of experience and evidence shows that it does indeed end).

The researchers plan to use lasers, nerve stimulation, and injections of peptides and stem cells. The companies hypothesize that these procedures will restart the brain. While they don’t expect to re-animate the dead in these trials, that is the ultimate goal. This trial is about showing that parts of the brain can be reanimated—not the whole person. Although like Frankenstein’s monster, the various parts are unlikely to be the same person before “death” (what terms would we even use?).

Bioquark is a company “focused on the development of novel biologics that have the ability to alter the regulatory state of human tissues and organs, with the goal of curing a range of chronic diseases, as well as effecting complex regeneration.” This is a perspective that death is simply a disease and they are going to find the cure. Revita is a company “which provides complete support to patients from query to till [sic] patients gets right stem cell therapy from our specialized doctors on board.”

Trial “participants” will have been declared dead from traumatic brain injury. They “will have been certified dead and only kept alive through life support.” Is it possible to be declared dead and yet still be alive? If the dead person is still alive, then as potential subjects, they will need to give informed consent to be part of the study? Or can a family member of health care surrogate provide consent? Do the dead have consent rights or can we do anything to them? If the we can do anything, they may be mad when we make them un-dead.

As if this announcement was not strange enough, another company, Lung Biotechnology PBC plans to manufacture lungs and other artificial organs (from organic tissue) for human transplant. And to be sure that the wow factor does not get behind the science, each organ will be delivered to the hospital via a drone manufactured by EHang, drone manufacturer.

In a world with great health disparities, these high priced approaches to curing death may gather media coverage and investor support, but they actually would affect a very small part of the population. While the few who can afford it would be living with their second-chance reanimated brains or their white-glove drone delivered personal organs, 21,000 people will still be dying every day from hunger, and 11% of all child deaths will still be from diarrheal diseases. Is pursuing Frankenstein’s monster really the best bang for our health care bucks?

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