Drug Revives Comatose Patients

ST. PETERSBURG, Fla. — A report that a sedative has the contrary side effect of reviving patients in a what has been termed a “persistent vegetative state” (PVS) has sparked calls for a moratorium on the diagnosis.

A British specialist in nuclear medicine, Ralf Clauss, and a South African general practitioner, Wally Nel, reported in the journal Neurorehabilitation in May that Zolpidem, sold under the commercial name Ambien as a remedy for insomnia, “may have efficacy in brain damage.”

Three long-term comatose patients were revived briefly on a daily basis over several years with injections of Ambien.

The treatment began after one patient was given Ambien to address his restlessness while in his coma.

“Lo and behold, he woke up 15 minutes later,” Clauss told a second journal, Nature.

The conclusion to the official report in Neurorehabilitation was less folksy: “Zolpidem appears an effective drug to restore brain function to some patients in the permanent vegetative state,” it stated.

It was this diagnosis that lay at the heart of the debate that lasted more than a decade over the life of Terri Schiavo. Her family, the Schindlers of Pinellas County, Fla., tried to save her life, while her husband argued that she did not want to live dependent on life support. Though Terri’s “life support” was a feeding tube, which is not considered an extraordinary measure to keep someone alive, and though she was not “brain dead” or terminal, Michael Schiavo ultimately won the right to let her die by starvation and dehydration.

Clauss told the Register that he and his research partner hoped their report would attract the interest — and money — of a medical research company so that a much wider study could be conducted.

Indeed, a British company focused on finding a cure for Alzheimer’s disease, Regen Therapeutics, has expressed an interest.

Clauss said he was “uncomfortable” about getting involved in the Schiavo debate but did suggest that the MRI scan commonly employed to assess brain activity was insufficient and that a scan that looks at the blood supply to the brain and the distribution of the blood within the brain ought also be used.

Not Dead Yet

But groups formed to defend the disabled, such as Not Dead Yet and the Terri Schindler-Schiavo Foundation, believe that the Clauss/Nel study is more evidence that the permanent or persistent vegetative state diagnosis ought to be dropped entirely.

“We at the foundation (operated by Terri Schiavo’s parents and siblings) are seeing that the PVS diagnosis is being commonly misdiagnosed … Common sense dictates that the removal of food and water based on this misclassification must end until further studies can be conducted,” said Terri’s father, Robert Schindler.

Her brother, Robert Schindler Jr., told the Register the family did not believe Terri was in a persistent vegetative state, but throughout her years of unconsciousness, her husband would never allow any treatment for her.

“I don’t believe even if the diagnosis is correct that we have the right to remove food and water,” he said. “If all that is being done for a patient is that food and water is being given them, they should not be terminated.”

Ted Furton, staff ethicist at the National Catholic Bioethics Center in Philadelphia, said the ethical issue in the Terri Schiavo affair is very much alive. The issue, he says, is, “Do people with PVS have lives worth living?” Those who answered No believed also, he said, that they had the moral right to kill her.

“There’s nothing wrong with PVS as a diagnosis,” he said. ”Nobody dies from PVS. Terri Schiavo was stable in PVS for years. She died from starvation and dehydration. The cause was the decision to take her food and water away. This was a case of passive euthanasia.”

Furton agreed, however, with the Schindler family that the PVS diagnosis was being used by some people as the standard for permitting euthanasia. “There is a school of thought, he said, that you are not a human being if you don’t have higher cognitive function.” Disability advocacy groups like Not Dead Yet “ought to be very concerned about this,” he said. “The message is: If you fall into a state sufficiently lacking in human dignity you will be terminated.”

Diane Coleman, president of Not Dead Yet, said her group has called for an end to the PVS diagnosis for years.

“This study just goes to reinforce our position that PVS cannot be properly diagnosed,” she said. “There should certainly be a moratorium on starving and dehydrating someone.”

In Pope John Paul II’s March 20, 2004 address “Life-Sustaining Treatments and Vegetative State: Scientific Advances and Ethical Dilemmas,” to members of an international congress, he addressed the widespread use of the term “vegetative state”:

“In particular, the term permanent vegetative state has been coined to indicate the condition of those patients whose ‘vegetative state’ continues for over a year. Actually, there is no different diagnosis that corresponds to such a definition, but only a conventional prognostic judgment, relative to the fact that the recovery of patients, statistically speaking, is ever more difficult as the condition of vegetative state is prolonged in time.

“However, we must neither forget nor underestimate that there are well-documented cases of at least partial recovery even after many years; we can thus state that medical science, up until now, is still unable to predict with certainty who among patients in this condition will recover and who will not.

“Faced with patients in similar clinical conditions, there are some who cast doubt on the persistence of the ‘human quality’ itself, almost as if the adjective ‘vegetative’ (whose use is now solidly established), which symbolically describes a clinical state, could or should be instead applied to the sick as such, actually demeaning their value and personal dignity. In this sense, it must be noted that this term, even when confined to the clinical context, is certainly not the most felicitous when applied to human beings.

“In opposition to such trends of thought, I feel the duty to reaffirm strongly that the intrinsic value and personal dignity of every human being do not change, no matter what the concrete circumstances of his or her life. A man, even if seriously ill or disabled in the exercise of his highest functions, is and always will be a man, and he will never become a ‘vegetable’ or an ‘animal.’”

Bioethicists

Coleman cited British and American studies indicating “persistent vegetative state” was misdiagnosed between 30% and 43% of the time. “People can be really conscious and still not able to communicate. PVS is that unreliable as a diagnosis.”

However, Kevin Keith, who teaches ethics to medical students in New York, said the studies showing misdiagnosis are a decade old, covering a period before current diagnostic criteria were developed.

“We have no current data indicating that PVS is being misdiagnosed. Ten years of evolution of diagnostic techniques have only improved things.”

Keith is skeptical of the Ambien study. “If it holds up — and this is a far beyond hypothetical supposition — it will certainly overthrow much of what we think we know about PVS. But there are good reasons to be extremely skeptical that it will be upheld.”

For one thing, the study has not been subjected to “even a preliminary peer review, ... let alone confirmation by other researchers.”

But Coleman is skeptical, in turn, of bioethicists who “feel that certain people should not have status as persons.

“They think it’s futile to treat those with dementia and strokes,” he said. “They don’t think it’s worth spending health dollars on you.”

Steve Weatherbe is based in

Victoria, British Columbia.