What caused 7 patients to regain consciousness after Medical Aid in Dying?

Rarely does a governmental report make our heart race, but this mysterious footnote was a jolt:

“From 2016 to 2022,” said California’s most recent dispatch on medical-aid-in-dying prescriptions and passings, “7 individuals regained consciousness after ingestion. No individuals regained consciousness in 2023 and 2024.”

What?

Seven terminally ill people drank the potion that was supposed to end their lives and…woke up? How? Why? When? Did they take more of the medication, then pass? Did they decide to stick it out to their diseases’ ultimate conclusion? Which drugs were used?

What, exactly, went awry?

These would have been the questions tumbling from our lips if we were among the number crunchers at the California Department of Public Health, the agency tasked with collecting and publishing data on what’s officially called the End of Life Option Act.

Officials apparently didn’t feel the same rush of incredulity.

“CDPH’s role regarding EOLA is limited to making the statutorily created EOLA forms available on its website, receiving the completed the EOLA forms, tabulating data, and providing the EOLA Annual Data Report on the CDPH website,” a spokesperson told us by email.

But, surely, this must have piqued official curiosity. Surely CDPH asked some other arm of government to look into what happened?

“CDPH does not have the information you are requesting,” we were told. “CDPH’s End of Life Option Act (EOLA) responsibilities are outlined in the California Health and Safety Code: California Health and Safety Code, Division 1, Part 1.85, Section 443-443.22. CDPH has no regulatory or enforcement authority over the EOLA…. Given CDPH’s relatively limited role with EOLA, we don’t have the insights you are looking for.”

Wow.

OK, then: How to unravel this mystery?

Help!

We turned to some of the doctors and experts on Medical Aid In Dying who we’ve become acquainted with over the past year. Our lament about our father’s painful passing in Florida — where there are gobs of old people but no MAID laws to make death more peaceful — morphed into an unexpected series of stories on same.

We learned that, despite MAID being the law of the land since 2016, some health care providers refuse requests for it on religious grounds, and it can be incredibly hard to access.

We talked with pioneers of MAID in California and told readers how to find a doctor who shepherds patients through the process.

We followed the numbers and found that California remains squeamish about MAID, using it far less than its Canadian neighbors.

We explored controversy over whether people in the early stages of dementia and Alzheimer’s should be able to choose MAID while they’re still of sound mind.

We answered folks’ burning questions about MAID: Will life insurance pay? Does God approve?

We worried that California would allow the law to sunset 2031 and take away our freedom to choose MAID; and we cheered when the governor signed the bill eliminating the sunset date, preserving our options for the coming decades when millions of us might need them.

And, when we asked the experts who helped us with all those stories to look at the footnote — saying seven people awoke after ingesting their end-of-life cocktails — we found that they were about as gob-smacked as we were.

Ghost data?

One suspected that CDPH is entering data manually from paper forms, and made errors, and that there are no true cases of regained consciousness.

The Academy of Aid-in-Dying Medicine, a Berkeley-based nonprofit, trains MAID providers, collects data from them, and has no record of patients regaining consciousness, the provider said. “We meet regularly and discuss all cases, anything out of the ordinary,” and there has been no discussion of anything like this.

Another doctor speculated that the seven cases might have other explanations. “When speaking to patients about possible adverse events, as required for informed consent, I would always mention the possibility of waking up, even though it never happened in my experience or the experience of the hundreds of physicians who communicate about their practices through listservs and other forms of communication,” the doctor said.

“What I routinely say to patients is that there can be prolonged deaths that can last over 24 hours (again, very, very rare). But if an inadequate amount of medication is ingested, or there is regurgitation of nearly all of the medicine, it is imaginable that someone could regain consciousness.”

We combed through every ELOA data report released by the state — there have been nine so far — and found no mention of regaining consciousness until the 2024 report, which was issued in July. Even though the events happened between 2016 and 2022.

The time span, though, may hold a clue.

The drugs used for MAID have changed over the years. In days past, there have been rare, but disturbing, reports of awakenings, as well as deaths that stretched out over many days.

In Oregon, the Death With Dignity Act has been law since 1998, and there were nine reported regainings-of-consciousness between 1998 and 2022, according to state data. The most famous, perhaps, was of lung cancer patient David Prueitt, who swallowed a supposedly lethal dose of medication and awoke three days later. “What the hell happened?” he asked his wife on Feb. 2, 2005. “Why am I not dead?” He lived for two more weeks before dying on Feb. 15, 2005.The drugs used for MAID have changed over the years.

Dr. Lonny Shavelson, director of education for the Academy of Aid-in-Dying Medicine, suspects that Oregon’s reported awakenings happened during its secobarbital period, a drug no longer used as a primary end-of-life elixir. The art and science of MAID medications have advanced considerably, he said.

Oregon’s annual reports detail those medications in a way that California’s do not. End-of-life drugs have included DDMAPh, a combination of diazepam, digoxin, morphine sulfate, amitriptyline, and phenobarbital; DDMA, a combination of diazepam, digoxin, morphine sulfate, and amitriptyline; and DDMP, a combination of diazepam, digoxin, morphine, sulfate and propranolol. Secobarbital has been unavailable for MAID use in Oregon since 2019, and pentobarbital has been unavailable since 2015.

The mystery footnote in California’s report may have grown from earlier medications as well. And/or inadequate dosage. And/or medication that was not kept down. But these are just guesses, not official explanations.

“I do know that the Academy has had its ear to the ground since 2020, and we’ve heard of zero awakenings (in any state),” Shavelson said by email. “The Academy’s data collection system, combined with other state organization information, a total of 3,332 deaths (and still counting), showed no reported awakenings since we started using the most recent protocol of DDMAPh.”

Best medicine?

Shavelson is a co-author of “The Pharmacology of Aid in Dying: From Database Analyses to Evidence-Based Best Practices,” a paper published in the Journal of Palliative Medicine in April.

“Much has been written about the ethics of aid in dying, but little about evidence-based care, especially the medications used,” the authors write. So they looked at the efficacy of four commonly used medication protocols, using time to sleep and time to death as proxies for efficacy.

“Our analysis of pooled data regarding aid-in-dying pharmacologic protocols is the first to analyze clinical outcomes related to successive formula innovations over a 26-year period. We conclude that DDMAPh is the most effective and reliable medication protocol for aid in dying. For patients and loved ones at the bedside, clinicians can now provide specific information about the outcomes of aid-in-dying deaths withDDMAPh: 93.2% under 5 hours (successful/acceptable), with only 0.4% of deaths in the >20-hour (outlier) category. While there may be other variables at play, the data at this time is sufficient to recommend the use of DDMAPh over all preceding protocols.”

The mystery remains about the CDPH’s footnote and what exactly it means. Were the right meds used? Were they administered correctly? What risk factors did the patients have? But it’s heartening to see that the state’s data agrees with the Academy’s data, that there were no reported awakenings in 2023 and 2024, Shavelson said.

“To my eye, if the seven awakenings occurred a while ago, that’s an indication of the progress we’re making and the failsafe nature of the dosage calculations of DDMAPh, so that even partial ingestions (which are common) still lead to deaths (and, I would add, since the patients remain unconscious throughout, comfortable deaths).”

In the U.S., MAID is legal in California, Colorado, Delaware, Hawaii, Illinois, Maine, Montana, New Jersey, New Mexico, Oregon, Vermont, Washington state and Washington, D.C. New York’s law is slated to take effect later this year.

We’ve asked CDPH for anything else they can tell us about those seven episodes — such as when they happened. We’ll keep you posted.