The Tragedy of Bioethics

At last week’s CBHD conference, a few of us were treated to a unique “Drinking-from-a-firehose” experience.  Jerome Wernow gave a talk with the eyesplitting title, “Bioethics:  Facing a Philosophical Theology of Tragedy and Mystery.”  Intrigued at the title in the conference brochure, but having no idea at all what it might refer to, I slid into a seat in the classroom where Dr. Wernow was to speak, prepared to be befuddled.  Instead, in the space of about about twenty minutes, those of us in the room were given an alluring glimpse into a poignantly beautiful picture for doing bioethics that alters what I see when I look at a patient.

I will attempt to present gleanings from the rich feast that was Dr. Wernow’s talk.  The early 20th Century Russian philosopher Nicloas Berdyaev wrote,  “There can be no moral life without freedom in evil, and this renders moral life a tragedy and makes ethics a philosophy of tragedy.”  As anybody who has witnessed the anguish of those who seek an ethics consult can attest, as anybody haunted by the dark questions our modern technology raises would agree, in bioethics all decisions are fraught with tragedy;  ethics consultants are actors in one-act medical dramas that are tragedies.  And tragedy is neither lessened nor assuaged when good and evil alone are used in bioethics’ calculus.  Our knowledge of good and evil is damaged, the product of a lie (“your eyes shall be opened, and ye shall be as gods, knowing good and evil“); it was in the very act of grasping for the tree of that knowledge that we were banished from the tree of life.  When we approach people whose stories have taken a catastrophic turn and we wield only the calculus of good and evil, our bioethics is left lifeless, empty, and tragic.  According to Wernow, to address tragedy we must turn to mystery, to “Mystery-revealed:” Christ, in whom is Life.  The question we ask as Christians doing bioethics is not just, “What is good?” but “How do I bring eternal life into this tragedy?  How do I bring the mystery of Life into the abyss?”

There was an amazed silence in the little classroom when Dr. Wernow finished.  Unfortunately, that is all I can leave the reader with.  I am not even sure that in my pathetic summary I presented Dr. Wernow’s vision remotely accurately;  his ideas poured out quickly and passionately, I could take only skeleton notes, and he has not as yet published an article or book that sets out the implications of the “Philosophical Theology of Tragedy and Mystery.”  But I sure love his vision of bioethics-as-drama instead of as sterile philosophical specimen;  and I can embrace the quest to bring the Mystery of Life into tragedy as a robustly and profoundly Christian way to engage and immerse myself in the tragedies of a fallen world.

 

STEPS in the wrong direction

One of the major tasks of bioethics since its inception has been to ensure the ethical conduct of scientific experiments involving human subjects.  One of the cornerstones of ethical experimentation (indeed of all medical treatment that respects the human dignity of the patient) is the concept of informed consent:  the study participant should know up front the purpose, potential benefits, and potential risks of participating in the study.

In the 1990’s, Parke-Davis, the manufacturer of the anti-epileptic medication Neurontin (generic name: gabapentin), conducted a trial called Study of Neurontin:  Titrate to Efficacy, Profile of Safety (STEPS).  This was a Phase 4 trial (performed after the medication was already on the market) whose professed objective was to study the efficacy, safety, tolerability, and quality of life among gabapentin users as the drug’s dose was increased.  Parke-Davis recruited physicians to enroll patients into the trial;  in all, 772 physician-investigators enrolled a total of 2759 patients into the trial.  The study resulted in two published papers.

It all sounds innocuous enough, no?

Recently, through legal action, all of Parke-Davis’s internal and external documentation relating to STEPS became available for review.  In these documents, a different picture of the trial’s objective comes to light.  A few quotes from the company’s internal memos:

– “Some indicators of [the study’s] success include 20% increase in new patients’ starts in March and a 3% market share in new prescriptions. . .”

– “STEPS is the best tool we have for Neurontin and we should be using it wherever we can.”

– “. . .at the very least, we should be looking to place as many managed-care patients as feasible in [STEPS] to prevent Lamictal [a competitor’s drug] starts.”

– Multiple strategic planning documents cite the STEPS trial itself, not the trial’s findings, as a key marketing tool for gabapentin.

– Parke-Davis monitored and analyzed the physician-investigators’ prescribing habits, finding increased prescribing of gabapentin among STEPS participants compared to a control group of non-participants.

Apparently, contrary to the trial’s stated objective, the purpose of STEPS was not science, but marketing;  the true subjects of the trial were not the patients, but the physicians.  The most important measured outcome of the trial was not the safety or efficacy of gabapentin, but whether and how much doctors changed their prescribing behavior as a result of participating in the trial.

Is this an ethical trial?  Some might say, sure, there was nondisclosure of the true intent of the trial, but c’mon, it wan’t Tuskegee, right?  I mean, nobody was hurt (unless you count the 11 patients who died, the 73 who experienced serious adverse events, and the 997 who experienced less serious adverse effects).

No, this was an unethical trial.  There could not be informed consent, as the true purpose of the trial was not revealed to physicians, patients, or IRBs.  In addition, using any human being in such a deceptive manner for monetary ends is inconsistent with respect for human dignity.

 

An article that reviewed STEPS and provided the quotes above appeared in the June 27 Archives of Internal Medicine;  the abstract can be accessed here.

 

Welcome to the Trinity Bioethics blog!

Warm greetings to the 300 or so alumni, students, and faculty connected with the bioethics degree programs at Trinity International University—and to others listening in!

The Trinity Bioethics Community (TBC) is a tremendous network of bioethics-trained people who have many insights and produce many resources that are well worth sharing. In addition to this blog, Trinity is launching a new online archive of excellent bioethics papers and projects that bioethics students at Trinity have produced. Members of the TBC are receiving information directly regarding how their best resources can become available through this archive. Whenever a new resource enters the archive, starting sometime in Fall 2011, posts to this blog will notify readers of its availability.

The alumni members of the TBC are also receiving information regarding how they can send to Trinity Town (the online alumni network) information describing the vocational and other settings in which they are using their Trinity bioethics training. Those communications will automatically be posted to this blog as well. So will announcements about bioethics-related events and other opportunities at Trinity.

Of special interest to many, though, will be the commentaries on news events and bioethical issues that will regularly appear in this blog. You are encouraged to reply to such posts as often as you can, to generate insightful discussions. Please also submit a new commentary/post of your own whenever you wish.

Wonderful new opportunities lie ahead for informing, challenging, and inspiring one another through the Trinity Bioethics blog!

 

John Kilner
Director
Trinity Bioethics Degree Programs