More on Researchers, Placebos,

and Overdoing It

"Cartoons and Poems following each article are created and copyrighted by Dr. Ackerman and cannot be copied or reproduced without his permission."

When I re-read my last article on sugar, it occurred to me that my readers might wonder why the cartoon was about placebos. The real purpose, however, was to exaggerate what happens when researchers push too hard to prove their point. Perhaps the poem summed it up better. All these years we've been subject to research and opinion that sugar intake means trouble, now it seems that it may possess more redeeming value than suspected. The idea was to push the point to a limit by using placebo as the foil. So when I noticed an article by Peter A. Clark in volume 30 of 2002 in the Journal of Law; Medicine and Ethics called "Placebo surgery for Parkinson's disease: Do benefits outweigh the risks?" I was intrigued. Maybe my little comedic farce about using placebos wasn't all that much of an exaggeration after all. Let's face it, there's been enough evidence in the past that as many as 62% of study subjects getting placebo pills have been shown, under the right circumstances, to respond to these supposedly unreactive pills with improvement or even side effects. And now, what about using placebos in surgery? Just follow this now. This is a real doozy.

If you recall, I discussed microdialysis twice recently. One use for the procedure was to place medication at the appropriate site, the putamen of the brain. However, microdialysis is not the only way to place something in the putamen. Perhaps you may recall a horrific method of treating mental illness called trepanation, which was supposed to liberate the demons, or whatever else was causing the problem. You may find it hard to believe but this apparently barbaric procedure has seen the light of day once again, not just in the dark recesses of the jungle by some medicine man, but right here in New York City at of all places the highly regarded Columbia Presbyterian Center. That's not all. This was no fly-by-night venture because it was financed by the United States government with a 5.7 million-dollar grant. The results of the study, used as a trial treatment for Parkinson's disease, were presented in April of 1999 by Doctors Freed and Fahn at a conference of the American Academy of Neurology. This was truly an epic study because it's carefully designed protocol involved placebo controls. That's correct. You've guessed right. The idea was to drill four tiny burr holes through the wrinkle lines above the eyebrows into the skull, then to inject fetal cells through those holes into the putamen of the brain. That's just fine, but what about the placebo controlled subjects? What did they get injected into their brains? Why, nothing of course. The results were nothing short of fabulous because the fetal tissue took hold, and seemed to establish a new network to produce the missing dopamine in two-thirds of the 20 transplant recipients. Good old placebo managed to kick in with 3 untreated subjects insisting that their symptoms had improved when they were contacted one year later.

Now this is where the legal and ethical aspects of placebo controls become fodder for discussion by such authors as Peter A. Clark and other medico-legal experts. In his treatise on the subject Clark concludes that, although the placebo effect is essential when doing research, if we are to keep things objective, we must nevertheless "not allow researchers to use individuals as a means to an end." He goes on to label the fetal tissue trials in which holes were bored into the skull of subjects who acted as placebo controls "unethical because it violates the principles of respect for persons, beneficence, and justice." He then brings up a number of more specific points about this particular study. But basically the important questions as they occur to me are first, "Do we have the right to perform placebo surgery - especially where certain dangers exist - on study subjects even though they have given their consent?", and second, "Are these subjects truly aware of the consequences?"

Clark's exposé was followed by an editorial written by Charles Weijer with a humorous title but serious content. The title was "I need a placebo like I need a hole in the head." The main points of contention, as I saw them, concerned whether surgical patients are a vulnerable population when faced with the choices involved in placebo-controlled research, and whether the simplistic approach used in such trials is capable of reducing research subjects to the level of lab rats.

It appears to me that the crucial element involved in deciding whether this sort of research is appropriate should rest with the individual who has the disease and may be desperate for an answer before it's too late. Unfortunately this is the point at which many of these individuals become determined to assume any risk, but at the same time they also become readily susceptible to becoming involved in sham treatment modalities, or dangerous experimental research projects.

For those readers more profoundly interested in the medico-legal and ethical aspects of research I highly recommend reading these two articles.

Cartoons and Poems following each article are created and copyrighted by Dr. Ackerman and cannot be copied or reproduced without his permission. Copyright © 2007 by Marvin Ackerman, M.D.

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