Can Ambien Wake Up PVS Patients?

The Guardian gives credence to a case report concerning three patients purportedly diagnosed in PVS for more than three years who were "aroused transiently every morning after zolpidem," a sleeping pill. That would be Ambien.

The report, by Clauss and Nel, of Royal Surrey County Hospital and of Family Practice of Pollack Park South Africa, was published in this month's issue of Neurorehabilitation.

There are 26 million annual prescriptions for Ambien, most of which are probably not to patients in a persistent vegetative state.

Recall that Ambien is oft reported to cause odd behavior like sleepcooking, and, as summarized on this page of the ever-helpful Yourlawyer.com, sleepdriving. The hypothesis that this set of side effects, which according to Aventis spokesmen occur in less than 1 in 1,000 cases - might be really really common in treating people who are basically dead strains credibility. But what a cool idea for a study. And imagine the informed consent process: give the med, wait until they wake up and (as the study reports) throw a baseball, then consent them to another day's dose.

At best this is the weirdest anecdotal report in the history of neurology - even for a journal that publishes case studies, and one wonders why on earth a larger group of subjects would not be studied before moving to this level of publication (the plural of anecdote is data?) about the most controversial area of end of life care on Earth.

But really the question is what this little report will do to the wide world of Schiavo.

Paul Root Wolpe comments on the most likely response from the right wing: "You see? They really are alive in there, their personalities are just trapped, and if we had given this to Terri she would be talking with us today. Killing them is murder."

So it really matters what is up with this study. Who are the authors? Clauss, a neuro has published a number of case reports about the effect of Ambien on various conditions, e.g., this letter in New England Journal in 2004 on its effect on Spinocerebellar Ataxia. He and Nel co-authored "Effects of zolpidem on brain injury and diaschisis as detected by 99mTc HMPAO brain SPECT in humans"" last year in a low-impact German journal. In both 2000 and separately in 2001 they claimed that Ambien aroused patients from a semi-comatose state, in a letter to the editor and in a case report, in the South African Journal of Medicine. Claus is a "Consultant Nuclear Medicine Physician" at Surrey, not exactly working in neuropharmacology, but has been active in publishing lots of these little case studies about a wide variety of uses of Ambien. Yet the Guardian writes:

Ralf Clauss of the nuclear medicine department of the Royal Surrey County hospital, one of the authors, said that clinical trials were now needed. He said the drug could have uses in all kinds of brain damage, including Parkinson's disease and Alzheimer's.

So is this the biggest story in the long history of debate about persistent vegetative state, plural anecdotal evidence of something extraordinary, or something else. We're digging.

This appeared on the What Does the Prayer Really Say blog by Fr. John Zuhlsdorf based in Rome. It contains his comments from a column to the Wanderer Newspaper several years back.

“PVS” patients and Zolpidem
CATEGORY: SESSIUNCULUM — Fr. John Zuhlsdorf @ 9:04 am

A serious biretta tip o{]:¬\ is due to American Papist (whom I put on my left side bar under "Good Blogs") for alerting me to an article about how a certain drug called Zolpidem brings "PVS" patients ("persistent vegetative state" - really a misnonmer) around for a while.

I wrote an article for The Wanderer on this PVS phenomenon and matters of nutrition and hydration a couple years ago. There was a conference held here in Rome and John Paul II made a strong declaration about the obligation to provide nutrition and hydration. This was also before the infamous Terry Schiavo case as well.

Here is the article I wrote for the 1 April 2004 number of The Wanderer.

Pope Outlines Care Of Persons In "Persistent Vegetative State"

By FR. JOHN T. ZUHLSDORF

ROME — "A man, even if he is gravely ill or impeded in exercising his higher functions, is and always will be a man, and he will never become a ‘vegetable’ or an ‘animal’."

When Pope John Paul II said this on March 20, he changed the grounds of bioethical debates about the value of and treatment of people in what is called a "persistent vegetative state" (PVS), and indeed the whole landscape of health care. The Successor of Peter made this lapidary statement at an audience for participants at an international congress March 17-20 on the subject at the "Augustinianum" in Rome.

The congress was sponsored by the International Federation of Catholic Medical Associations (FIAMC) and by the Pontifical Academy for Life.

In previous statements, the Pope has never gone this far, or spoken so clearly, on this hotly debated issue. In the past, the Holy Father had said that there is a presumption in favor of giving nutrition and hydration to these people. He has gone beyond that now by stating that it is a moral obligation to provide it. The foundation of this thought is in his statement that "the sick person, in a vegetative state, awaiting recovery or his natural end, has the right to basic health care, and to the prevention of complications linked to his state."

This applies to people who are in PVS, but it must affect the care of those with similar conditions, such as Alzheimer’s disease or forms of coma or dementia.

The term PVS describes people who are in a state of unconsciousness which endures for a long time. They may continue in this state permanently, but they also may emerge from it, though this is rare when they have been in this state for a long time. The very term "PVS" is seen by some to be inaccurate. It somewhat describes human beings who are "cognitively disabled," which places them more in the category of people with disabilities, than in the category of patients who have need of special medical treatments to stay alive.

The point is this: People who are in PVS can be otherwise healthy but are incapable of taking food and water on their own. Providing people with assistance in taking food and water is not special medical treatment, it is not "therapeutic." It is "care" not "therapy" or "treatment."

People who are in PVS are often not seemingly totally inert. They often react to stimuli around them. Unlike people in a persistent coma, they have sleep cycles. Those who emerge from a PVS regain higher functions. They feel pain. They can emerge from their state. They react to different people differently. Those who care for PVS people speak of the "mother factor": If a stranger enters the room they give no reaction, while when their mother or a loved one comes in they do. This could negatively impact a correct diagnosis of this condition, given that exams are conducted by strangers.

PVS people after emerging can recount that they were aware of things around them, what people did and said, and what it felt like when they were being starved to death, a common "treatment" applied to them.

PVS is being widely misdiagnosed. Many who actually have some other problem are being labeled PVS improperly and then actively killed through the withdrawal of nutrition and hydration.

Helen Gill-Thwaites of the Royal Hospital for Neurodisability in London, England, during the above-mentioned conference in Rome, presented figures on misdiagnosis: Of patients referred to them with a diagnosis of vegetative state, 43% were misdiagnosed, 33% emerged from the state they were in, and 25% remained in a vegetative state. Of the misdiagnosed patients, over 40% could write messages, over 60% could do simple math, and over 80% could make choices. Elsewhere, they might be simply misdiagnosed and then starved to death.

According to Joannes Lelkens, emeritus professor of anesthesiology and reanimation at the State University of Maastricht, in Netherlands, in 2002, the total number of deaths was estimated at 140,000. Of these deaths, 8,400 (6%) were caused by "terminal sedation"; 5,460 deaths (3.9% of the total) were caused by palliative sedation with denial of food and fluids. During the conference, Lelkens called this procedure "manslaughter."

After his talk, another Dutch doctor, J.C.M. Lavrijsen (who had delivered the paper "Letting a Patient in a Vegetative State Die in Hospital Under Direction of a Nursing Home Physician"), rose to ask if Lelkens was accusing him of "manslaughter." Lelkens responded, "There is no other definition for it."

In 1995 a woman named Kate Adamson had a terrible stroke. She was misdiagnosed as PVS, when in fact she was in what is called "locked in state" (completely awake and aware [!] but unable to communicate). Even after the doctors realized she was awake and aware, they tried to get her husband to "let her go," but he refused. Another condition developed that required surgery and they had to withhold nutrition before and for the sake of the surgery, though they kept her on a saline IV for hydration. She was entirely awake and aware and lived to recount the experience (Kate’s Journey: Triumph Over Adversity, 2002). They stopped feeding her for eight days.

Although they had given her inadequate anesthesia for the surgery for a few hours, she said that that was nothing compared to the agony of hunger and thirst that persisted for days:

"You have to endure the physical pain and on top of that you have to endure the emotional pain. Your whole body cries out, ‘Feed me. I am alive and a person, don’t let me die, for God’s sake! Somebody feed me’."

A prevailing treatment of people in PVS is to withhold food and water until they die of dehydration. Since they are disabled, they are incapable of expressing their terrible suffering as they are dying. While mild dehydration is the loss of no more than 5% of the body’s fluid, and 5-10% is considered moderate dehydration, severe dehydration — loss of 10-15% of body fluids — is a life-threatening condition that requires immediate medical care. Yet, it is precisely this intentionally necessitated therapy which is being purposely denied, with a lethal intent. They inflict the need for medical intervention by establishing the conditions leading to death by dehydration, purposely, and then they purposely deny the therapy to reverse the condition they inflict.

Put yourself in their straitjacket.

What happens to you when you die from dehydration? First, think about going for a day without a single drink of water, two days, three . . . nothing. You would find something to drink, urgently crave it, set aside every other goal to get water in any way. You would suffer. Then what?

Imagine that you are unable to move or communicate according to your wishes. Maybe you are strapped down, gagged, blindfolded, isolated. The people around you decide that, since you are not communicating with them, or demonstrating that you are a "human being" because you are not revealing use of your higher functions, you should die. They stop feeding you or giving you anything to drink. Period. How long before you are mildly hungry and thirsty? Before you are really thirsty? When doctors decide to withhold nutrition and hydration from PVS people, who are cognitively disabled, they die of thirst long before they die of starvation: The cause of death is severe dehydration.

So, as you lie there, what is going on in your body? When your body’s fluid supply is severely depleted (because you are taking none in) and down by around 15%, hypovolemic shock or "physical collapse" occurs, that is, your blood supply gets lower and lower until you don’t have enough blood volume to function.

Your skin becomes pale and clammy. Your heart starts to race and your breathing becomes rapid and shallow. Unless you get water soon, it will get harder and harder to reverse your condition. You soon desperately need medical care. Your blood pressure drops so low that sometimes it can’t be detected at all. Then your extremities become blotchy and mottled as your body starts to shut down the periphery, shunting an ever-decreasing volume of available blood to the core, the heart and vital organs.

If you are conscious, your thirst is agony. Your temperature rises and when it hits 107°F (41.7°C), it starts to damage your brain and other organs. Your lips and tongue crack. Your nose bleeds from the dryness of the mucous membranes. You are wracked with pain from the heaving and attempts to vomit. You can’t tell anyone how much you are suffering. Since those around you don’t see your suffering, they think you must not have any pain. This appears to be "merciful."

This is how they purposely kill helpless people. Let dehydration happen to a football player during practice on a hot summer day and everyone goes crazy, pointing fingers and making accusations, filing lawsuits and suing everyone in sight. But this is done daily in the USA and other countries to people who are otherwise healthy, and simply need the love and care that any person with a disability needs. Lock a horse in a stall without food and water and you will go to jail.

Normal Care, Not Therapy

Keep in mind the difference between a medical treatment and withholding of nutrition and hydration. Chemotherapy attempts to stop or reverse cancer. Antibiotics treat infections. Withholding nutrition and hydration does not treat anything.

It must be underscored, however, that there are cases in which it harms a patient to give him food. In those cases, it is legitimate to withhold it so as to not impose a disproportionate burden which will cause greater suffering than benefit. This can be the case when a dying person has stomach cancer, or another condition in a terminal stage.

Most PVS people retain reflexes. They digest food without problems and are otherwise healthy. Thus, withholding nutrition and hydration in these cases is murder, for it has no other intention than the death of the person. Being hungry and thirsty is not a disease or disorder that requires medical treatment. Hungry and thirsty people need food and water, and they have a basic human right to have it. Purposely keeping nutrition and hydration from a hungry and thirsty person until he dies is murder.

Moreover, the means of assisting PVS people in taking nutrition and hydration, even when requiring the placement of a feeding tube, has become so easy under normal circumstances in advanced countries, that it cannot be argued to be extraordinary treatment.

Furthermore, pain studies done with people in PVS indicate that their electroencephalographic responses to pain stimuli are similar to those of a conscious patient. They just can’t show you the pain.

Bishops And Dissenters

In the United States, some regional conferences of bishops have made statements relative to the issue of artificial nutrition and hydration. The best presentation has been that of the bishops of Pennsylvania (cf. Origins, January 30, 1992). Similar positions are held by the bishops of New York, New Jersey, Delaware, Maryland, and Florida.

They say, as the Pope had said, that we must recognize a presumption in favor of the supply of nutrition and hydration, allowing its withdrawal when it is futile or creates a greater burden than benefit.

The 2001 good statement of the USCCB entitled Ethical and Religious Directives for Catholic Health Care Facilities (directive 58) holds to this same position. The bishops of Texas do not so far hold a presumption in favor of nutrition and hydration for PVS people (though two bishops dissented from that opinion).

Now, however, the Pope has gone beyond a presumption in favor of giving them food and water. The Supreme Pontiff has stated that people in PVS in no way lose their intrinsic dignity as human persons. As human persons we have moral obligations toward them. "Therefore," said the Pope, "the sick person, in a vegetative state, awaiting recovery or his natural end, has the right to basic health care, and to the prevention of complications linked to his state." The deliberate withholding of nutrition and hydration is "euthanasia by omission," since it has no other purpose than to cause the death of the person.

As a result of this new clarification by the Pope, Catholic theologians and medical experts who have favored the withholding of nutrition and hydration from PVS people will have to revise their positions and cease this improper practice.

For example, Fr. Kevin O’Rourke, OP, has been arguing that giving nutrition and hydration to a persistently unconscious person is of no real benefit, since it does not in itself restore the person to the use of his higher cognitive functions. Giving nutrition and hydration only preserves, in his view, biological life, rather than human life. Thus, he seems to chop the human person into pieces. They have relative worth according to the extent of the use of higher functions.

O’Rourke has argued that there is a presumption against giving nutrition and hydration to PVS people. This has stood in contrast to the Pope’s previous statement stating a presumption in favor of the same. The Pope’s newest statement goes further and doesn’t "presume," but states that they in fact have a right to nutrition and hydration. Fr. O’Rourke must now abandon his position.

O’Rourke, and others who accepted his arguments, must change their positions publicly, so as to help undo some of the damage they have done in convincing some Catholic and non-Catholic physicians that they could deliberately kill people by letting them die of thirst. This must be public because it can affect, for example, the formation of priests who will someday be called upon to give counsel and advice to families making decisions concerning care for loved ones in different states of illness or, in the case of PVS, disability.

Not all Catholic seminaries have had sound moral theology formation for candidates. One of the gurus of unacceptable moral theology, the late Fr. Richard A. McCormick, SJ, supported O’Rourke’s position. McCormick has been widely used in the past in some moral theology courses in seminaries. A public reversal of position by O’Rourke, and public adherence to John Paul II’s position, would be valuable and edifying.

There is great emotion attached to this issue and the debate has been bitter. It is to be hoped that the Pope’s words will calm the storms and bring clarity to the questions at hand.

One presenter at the conference in Rome, Fr. Norman Ford, a Catholic priest from Melbourne, Australia, and effectively in agreement with O’Rourke’s position, gave a free communication paper called, "Ethical Reasons Why Medically Assisted Nutrition & Hydration May No Longer Be Needed or Good for Patients Diagnosed as Permanently Unconscious." Ford argued that, in the past, "in history," there was no ability to feed people who were PVS and thus they died from their condition "naturally."

Maurizio Calipari, a bioethicist and a member of the Pontifical Academy for Life, stood up and responded to Ford saying that a century ago many women died in childbirth. Should we therefore not help pregnant women today because in the past we couldn’t do as much to help them? In other words, what we can do for these people in PVS now is hardly to be considered unusual or extraordinary.

Creeping Incrementalism

The famous Terri Schiavo case in the United States has brought many of these issues to the fore. The courts are involved now in establishing legal precedents for withholding and withdrawing nutrition and hydration. Legislatures are working to establish laws favoring killing helpless people this way "legally." Aside from the obvious immorality of such laws, even when concerning the very small group of people who are genuinely PVS, the vagueness of the laws, and the method of what I call "creeping incrementalism" will eventually extend the same "legal" right to kill patients suffering even from Alzheimer’s disease and other forms of dementia.

Basically, from an application of starving to people who are persistently cognitively disabled, who are unconscious and unable to communicate, there will be a move to do the same to people who lack "meaningful" consciousness, who are mentally less capable than an acceptable level determined by "experts." This is the path to a chilling new eugenics.

The fact is that we just don’t know what PVS people and in other states too, for that matter, are capable of. We just don’t know if they are going to emerge or not. We cannot know what they are thinking or feeling as they lie there.

As the Holy Father concluded so forcefully, people who lose expression of higher faculties are nonetheless still human beings with dignity and they have the right to proper care. Nutrition and hydration is care, not therapy for an illness or pathological condition.

It is their right and our duty as long as it is not creating a greater burden and suffering than benefit.

The conference in Rome was an important occasion and it precipitated this strong statement of John Paul II which must now completely reshape expressions of Catholic teaching on the care of patients who are PVS as well as others in similar conditions.

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