Unquantifiable Risk
Everyyear, the Medicine and Theater Selective makes creative and critical/analyticalinquiry into subject matter involving the ethical dimensions of physician/patient interaction.The over-arching premise of the Selective is that the work of making theater canalsobe a unique meansof probing the moral ambiguities that characterize ethical issues,particularly when its processes are informed not only by the imagination but also byintellectual rigour, and careful attention to the difference between art and propaganda.This year (Fall 1997), the field of inquiry has been xenotransplantation. Inspired chieflyby eventsand arguments surrounding a 1995 baboon bone marrow transplant to an HIVinfectedpatient, the Selective, during a semester's discussion, research and analysis,created"Unquantifiable Risk," a work which invites reflection on a range of issues provokedby suchaggressiveand radical healing intervention: beneficence versusambition;research versustherapy; resource allocation; the corporate partnership-healthcare institutionequation; and the value and meaning of risk assessment, all in the context of theinherently fiduciary nature of the physician/patient-research subject relationship.
CHARACTERS
NARRATOR
DR. GIPP EDWARDS, a transplant surgeon and xenograft researcher.
DR. MAUREEN BENJAMIN, CEO, Benjamin Healthcare Technologies.
HARLEY SMOOT, an indigent, 34 year-old xenograftcandidate.
DR. TAMARA REGAN, medical ethicist; member of Walter Grey Hospital IRB.
DR. MONROE BARNES, a cardiovascular physiology researcher; member of theWalter Grey Hospital IRB.
DR.JANE ALLEN, infectious disease specialist and AIDS researcher; member of WalterGrey Hospital IRB.
STEPHANIE SMITH, a 17-year-old xenograft candidate.
DR. ROSEMARYDEAS, Hospital Administrator, Walter Grey Hospital.
ALEXIACOLBY,a fabulously wealthy xenograft candidate.
RICHARD FABER, a 65-year-old xenograft candidate.
SCENE 1
NARRATOR: Drs. Benjamin and Edwards discuss the project.
DR. EDWARDS: Hey Maureen, how are you doing today?
DR. BENJAMIN: Fine; I just wanted to touch base with you about the project.
DR. EDWARDS: I'm glad you asked. Jane Allen from Infectious Disease has beenmaking a lot of waves about retroviruses and what-not; but I think it's just amatter of smoothing out the wrinkles.
DR. BENJAMIN: Do you think she has a lot of support?
DR. EDWARDS: Well, right now it's token opposition; but it definitely coulddelay the project. Maybe she would think differently if she were waiting on thetransplant list.
DR. BENJAMIN: Well, I haven't seen Rosemary in a while; so maybe I'll stop byand make sure we still have her support. How's the patient recruitment coming?
DR. EDWARDS: I have four likely candidates. I plan to speak with each of themtoday.
DR. BENJAMIN: Does anyone in particular stand out?
DR. EDWARDS: I hope that this 17-year-old girl will be a player for us. She'sprobably the healthiest! Her parents are receptive, but I think she is reallyapprehensive.
DR. BENJAMIN: If that doesn't work out, how do the other patients look?
DR. EDWARDS: I don't think we can go wrong. [Beeper goes off]Let me knowhow it goes with Rosemary.
DR. BENJAMIN: All right.
SCENE 2
NARRATOR: Dr. Edwards visits with xenograft candidate Harley Smoot. Smoot isa 34-year-old unemployed construction worker who is a rehabilitated I.V. druguser since 1992. He currently is suffering from a chronic bacterial endocarditisaffecting multiple heart valves, and desperately needs a new heart.
DR. EDWARDS: Hello, Mr. Smoot. The nurse paged me; how are we doing today?
MR. SMOOT: I'm startin' to like this place. The food's all right; and I caught threebasketball games last night.
DR. EDWARDS: Did the Bulls win last night?
MR. SMOOT: Yeah –the Hornets had 'em by two, but my man Jordan hit a threepointerwith seven seconds left….But enough about basketball, Doc. I've beenthinkin' about what we talked about the other day, and I think I'll go with the pigheart instead of trying to wait for a real one. I know I'm pretty sick and I don'tthink I'll make it too long. The only thing is, I don't got any money.
DR. EDWARDS: We can find ways to handle the cost.
MR. SMOOT: You mean I ain'tgotta pay for a thing?
DR. EDWARDS: No, that will all be taken care of. Because this is an experimentalprocedure, we have funding that will provide care for you.
MR. SMOOT: Can you put an animal heart in me and make it work? I ain'tgonnastart oinking and shit am I?
DR. EDWARDS: I believe my procedure can help you. But right now I need you torelax and not get excited when your Bulls get beat by my Knicks.
MR. SMOOT: Shiiiit—my Bulls are going all the way.
SCENE 3
NARRATOR: Three members of the Institutional Review Board (IRB) are sittingtogether in the Walter Grey Hospital cafeteria—Dr. Monroe Barnes, a cardiovascularphysiology researcher; Dr. Tamara Regan, a medical ethicist; and Dr. JaneAllen, an infectious disease specialist and AIDS researcher. Previously, Dr.Edwards had submitted a proposal to the IRB that was returned to him as a"CONDITIONAL APPROVAL." The topic of this informal gathering is to discussthe resubmission of Dr. Edwards' xenograft transplant proposal with thenewly revised criteria.
DR. REGAN: What do you guys think about this? I mean, a pig heart in a person?
DR. BARNES: As a cardiovascular physiologist, I think it's an excellent idea. Itcould save countless lives.
DR. ALLEN: But we need to think about the repercussions—if an unknowndisease is unleashed on the population, it could be more deadly than AIDS. From a public health standpoint, there is too much at stake!
DR. BARNES: I understand your concern; however, I feel the academic benefitsdefinitely outweigh the potontial harm. Think about what this could mean to science.
DR. REGAN: Science??? So, this is all about Dr. Edwards' career, isn't it? At leasthe's using a pig and not a poor baboon. I definitely would not agree with using aprimate to promote his career; but there are still some troubling ethical concerns.
DR. ALLEN: To hell with the ethics. There has already been a retrovirus identifiedin porcine tissue, for God's sake! And in multiple copies, no less. We've gotto do some serious characterization of this thing before we even consider introducingit into a human being.
DR. BARNES: You know, Jane, you're right. There's always a risk. However, noone has been able to quantify how large the risk is. Therefore, I think it would bein everyone's best interest to move forward in the name of saving lives.
DR. REGAN: Is it eternal life we're after? We're spending 14%of our GNP onhealth care, and millions of Americans still don't have access to primary care.With 5.5 billion people on the planet, should we be rebuilding dying humanswith healthy animal parts?
DR. BARNES: Well, Dr. Regan, you haven't had any problems with human-to-humantransplants; so why are you making such a big deal aboutxenotransplantation—which could potentially eliminate the side effects of immunosuppressionand rejection with genetically engineered animals.
DR. REGAN: It's true—the genie is out of the bottle. Our grandmothers andclosest friends have benefited from these technologies. But with scarce resourcesin an ever-exploding population, we need to decide what wishes we wanted thegenie to grant in the first place.
DR. ALLEN: But there's still the issue of the retroviruses. We have no idea of theirpotential pathogenicity in humans. In fact, researchers have already found thata single pass of this retrovirus in tissue culture produces an infectious virusresistantto complement. That's our first line of defense! Gone!
DR. BARNES: In vitro. Not in vivo. No one knows what happens in vivo. There isno test that will prove it's 100% safe. To stop progress in the name ofunquantifiable risk is ludicrous. People have been working with and eating
swine for centuries without documented disease transmission.
DR. ALLEN: That we know of.
DR. REGAN: I can see we're getting nowhere.
DR. BARNES: And neither will research if we listen to the two of you.
SCENE 4
NARRATOR: Dr. Edwards meets with his favorite transplant candidate. StephanieSmith is a 17-year-old senior in high school, who plays basketball and is anhonor roll student. She is suffering from viral myocarditis.
DR. EDWARDS: Hey, Sweetheart, how are you doing?
MS. SMITH: I don't know; you're not going to give me another shot, are you?
DR. EDWARDS:No, no, Stephanie—no more shots today. You must be a populargirl—those sure are beautiful flowers.
MS. SMITH: Yeah, my boyfriend got me those roses. My basketball team sent methe tulips. But my favorite ones are the ones over there that my dad got me. Didyou see my parents out in the lobby?
DR. EDWARDS: Yes, Stephanie. I just got done talking with them, and they seem tofeel confident in the surgery; but I wanted to see how you're feeling about things.
MS.SMITH Well, I know I need a heart. And I know that it would be a long wait fora human heart. But I am not sure how I feel about walking around with a pig'sheart!
DR. EDWARDS: Well, I know it may sound crazy to be putting a pig's heart intoyou; but you would be amazed at how similar the two hearts actually are. In fact,we've been using animal parts for many years; especially pig heart valves.
MS. SMITH: Is it going to beat as long as the human heart would?
DR. EDWARDS: We really don't know; because it is a brand new procedure.[Pause.]You know Stephanie, ultimately, the decision is yours.
MS. SMITH: Will I be able to make it to the prom? [sniff, sniff.]
DR. EDWARDS: Stephanie, my job is to do everything in my power to make surethat you make it to your prom. This is the best option for you. I believe my procedurecan help you.
SCENE 5
NARRATOR: Rosemary Deas, MD, MBA, Walter Grey's Hospital Administrator,is meeting in her office with her long-time friend and colleague, Maureen Benjamin,MD, DVM, MBA. Dr. Benjamin is the CEO of Benjamin Healthcare Technologies, which is the supplier of Dr. Edwards' porcine organs; and partiallyfunds Dr. Edwards' xenograft research. For the last 15 years, this company hasbeen involved in a number of experiments at the hospital. The company's successhas been in antimicrobial therapy, pacemaker technology, and geneticengineering.
DR. DEAS: Hey Maureen, come on in.
DR. BENJAMIN: Hi, it's good to see you. Thanks for taking the time to meetwith me.
DR. DEAS: No problem. How have you been? I've missed seeing you at soccerpractice this year.
DR. BENJAMIN: Well, Jason decided to play football this year. Well, anyway, I amsure you know that my company is working with Dr. Edwards on thexenotransplantation trial. I've heard it's been meeting some resistance from yourID folks.
DR. DEAS: Yeah. Dr. Allen from 10 has been voicing concern over the possibilityof porcine retroviruses; and Dr. Edwards told me that she has been putting pressureon his transplant team recently.
DR. BENJAMIN: Well, let me give you the rundown: One class of endogenousporcine retrovirus has been described. However, thanks to genetic engineering, wehave worked out a means to block its expression in our products. We have incorporateda ribozyme into the porcine genome that digests PERV RNA, preventing viralexpression. About the issue of other endogenous retroviruses, we find no evidenceto suggest the existence of such viruses. We have used RNA primers to search theentire porcine genome for transcriptionally active retroviral agents; and are confidentthat no such agents exist in our products. Even if something were to exist, therisk of anything harmful happening is really insignificant.
DR. DEAS: So, with the molecular technology to test for and eliminate anyretroviruses, it seems like there is not much risk.
DR. BENJAMIN: The risk is minimal, and I am confident that we've taken thenecessary precautions to be able to proceed with trials at this time.
DR. DEAS: Well, great. I am getting really excited about our partnership. I think itwill be a real success.
DR. BENJAMIN: We will meet future obstacles; but, hopefully, together we canhave a real impact on the field of transplantation. I'm going to leave these articleswith you. If you have any questions in the future, just give me a call anytime.
DR. DEAS: Okay, I will. Thanks for stopping by.
DR. BENJAMIN: It was great to see you.
SCENE 6
NARRATOR: Dr. Edwards meets with Alexia Colby, who is a famous heiress and, a major contributor to Walter Grey Hospital. The cancer research center has beennamed in her honor. She prefers the human organ transplant, but Dr. Edwards raises the alternative of "bridging."Using the porcine heart will allow her moretime to await a humanheart. She has, an abnormal/dysfunctional pericardium as a result of radiation treatment twelve years ago for Hodgkin's Disease.
MS. COLBY: Hey, Doc, I’m glad you stopped in. I’ve had my personal assistant doing some research on this procedure, and I am not really sold on it. I’ll feel more comfortable waiting on a human heart.
DR EDWARDS: I can appreciate your concern, Alexia. But the longer you wait for a human heart, the greater the risk of complications; and looking at your numbers, time is of the essence.
MS. COLBY: Listen, I’ve pulled a few strings and I am pretty sure that I am high on the transplant list.
DR EDWARDS: While you may be high on the list, realistically you might have to wait years; and I’m concerned that your heart isn’t going to make it. This bridge therapy is your best alternative while waiting for a match.
MS. COLBY: What are you proposing?
DR. EDWARDS: alexia, this is not the final curative procedure that you and I are looking for. What it will do is provide a safer waiting window until the proper human donor can be matched.
MS. COLBY: Let me get this straight: If you implant the porcine heart I will still be able to receive a human donor heart as soon as one becomes available
DR. EDWARDS: Because this is an unprecedented procedure, your participation will in no way affect your standing on the transplant list.
MS. COLBY: You don’t seem to understand, Dr. Edwards, I am not concerned about my placement on the list. Will my body be able to handle the human transplant when it eventually becomes available?
DR. EDWARDS: To be perfectly frank, I firmly believe that my procedure will ensure that you will even be alive for a human transplant whenever that opportunity presents itself. I don’t want to scare you, but we have exhausted all of the conventional techniques for you, and we need to move swiftly.
MS. COLBY: Well, I am still a little skeptical about the porcine procedure, but Irealize the severity of my condition, and that I am running out of time. If youreally think this is my best option, I will trust your judgment and go through withthe procedure. If this works, we might just see you strolling to pick up your NobelPrize next year.
SCENE 7
NARRATOR: Dr. Allen, the 10 specialist on Walter Grey's IRB, by chance encountersHospital Administrator Deas in the hallway.
DR. ALLEN: Rosemary, I'm hearing some false, malicious rumors that you areactually considering supporting this xenotransplantation fiasco.
DR. DEAS: Yeah, it makes sense financially. With all this downsizing, everyhospital needs its niche, not to mention the potential of this procedure forsaving lives.
DR. ALLEN: What a crock! I really think you need to reconsider this from aninfectious disease standpoint. This is a very experimental procedure, with veryreal dangers. Money should be the last of our worries. How'd you like your
hospital to be known as the birthplace of the next retroviral epidemic? Huh?Huh?
DR. DEAS: Settle down, Jane. I talked to Maureen Benjamin about the project theother day. She explained the relevant risks in using porcine parts, and I don'tthink the risk in this case outweighs the potential benefits.
DR. ALLEN: Maureen Benjamin has nothing to lose in this scenario—she is theCEO of a for-profit corporation. She cares about money alone, and it is blindingher to the fact that real people are going to be exposed to—and likely affectedby—an uncharacterized retrovirus.
DR. DEAS: Well, in speaking with Dr. Benjamin and reading the literature, I amsatisfied that the appropriate precautions have been taken to be able to proceed.Do you have any additional information to support your arguments?
DR. ALLEN: Of course –I am not the only one who has these concerns. I reallyhope you'll give this the attention it merits. There is much to fear, Rosemary.
DR. DEAS: I understand your concern. We'll talk later, after I've had a chance toreview this.
DR. ALLEN: Thanks. I'll be in touch.[Leaves Deas' office.]Well, you can't say Ididn't warn her.
SCENE 8
NARRATOR: Dr. Edwards meets with Richard Faber, the last of his four xenograftcandidates. Richard Faber is a 65-year-old, retired steel worker withsevere congestive heart failure. He has previously had two myocardial infarctions,15 years of uncontrolled hypertension, hypercholesterolemia, and is a heavysmoker. He is married, with two daughters, one of whom is pregnant with hisfirst grandson.
DR. EDWARDS: Hello, Mr. Faber, how are we doing today?
MR. FABER: Not doing so hot, Dr. Edwards. You know all about my condition.I'm real worried.
DR. EDWARDS: Well, your case is under serious consideration forxenotransplantation. I believe my procedure can help you.
MR. FABER: Thank you. I know I only have 6 months to live and I'm willing to doabout anything, but I am a little confused. What is xeno... xenotrans...??