May 23, 2006

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, 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.

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