Figures don’t lie, but pharmaceutical manufacturers figure

On April 19th, the Office of Fair Trading, a UK consumer-watchdog agency, accused GlaxoSmithKline of delaying competition with its antidepressant drug paroxetine (Brand name Paxil in the US, Seroxat in the UK) by paying generic manufacturers to delay making a generic version of paroxetine.

If this is true, it is not the first — or worst — bit of subterfuge surrounding paroxetine and other antidepressants. Before the FDA approves a drug, it requires scientific evidence demonstrating that the drug is reasonably safe and actually does what it claims to do. However, when results from clinical trials have shown that their drugs work no better than placebo (sugar pills), antidepressant manufacturers have often chosen not to publish those results, or have published the trials but doctored the results to make them look like the drugs actually do something more than the placebo does.

An example from a 2010 article in Psychotherapy and Psychosomatics that reviewed the published and unpublished research on antidepressants: In one review of 74 trials, “According to the FDA scientific reviews . . . , only 38 trials (51%) found positive drug/placebo differences and 37 were subsequently published. The FDA judged the remaining 36 studies to be either negative (24 studies) or questionable (12 studies) – that is, no difference on the primary outcome but significant findings on a secondary measure. Only 3 (8%) were published reporting negative results, while the remaining 33 were either not published (22 studies) or published as though they were positive (11 studies) in contradiction to the FDA conclusions. ” (italics mine)

The problem? Physicians use evidence from different sources, including published studies, to make treatment decisions. If most of the studies that find no difference between drug and placebo are left out of the analysis or dressed up to make them favor the drug, then the physicians make recommendations based on skewed data that grossly misrepresents the efficacy of antidepressants. Not only are countless people harmed by medication side effects, countless more may be harmed by thinking that their problems in life can be cured with a pill, or that they’re at the mercy of a “chemical imbalance” in their brain.

A whopping 11% of the general population now take an antidepressant. If the decision to prescribe the antidepressant is based on published data, which is skewed to show a greater treatment effect for antidepressants than is warranted, then our health care systems pay an awful lot of money to pharmaceutical manufacturers for medications that many times work not because of anything in the pill, but because the patient believes the pill will work (i.e., the placebo effect).

The authors of the aforementioned review conclude, “The reviewed findings argue for a reappraisal of the current recommended standard of care of depression.” In a “Prozac nation” that values quick-fixes and “a pill for every ill,” where direct-to-consumer marketing is relentless and irrational, such a reappraisal may be a long time in coming.

A Place Where We Ought to Fear to Tread

The current issue of World magazine includes a brief article about this work going on in the United Kingdom: attempting to circumvent certain inheritable diseases by replacing the mitochondrial DNA in a mother’s oocyte with mitochondria from an oocyte of another woman.  The re-engineered oocyte is then fertilized in vitro, with subsequent implantation of the embryo, etc, etc.  The article’s provocative title was, “Heather has two mommies.”

If one accepts IVF and is inclined to observe the “therapeutic boundary” as placing limits on what genetic manipulations we should be willing to undertake, then this project would seem to qualify as treatment, rather than enhancement, before a new individual person is conceived, and could qualify as an acceptable use of reproductive technology.  And one can argue that the risk/benefit analysis, in a case like this, is clearly positive (perhaps requiring that all embryos so created are implanted with the intent to carry them to term).

But I’m not so sure that a line has not been crossed here.  Still, to object on grounds of “repugnance”—as I would—would seem to succeed only if said repugnance reflects deep, universal moral sentiments and intuitions that are expressions of a natural moral law.  And a lot of people would not find the case here repugnant.  To object—as, again, I would—on the grounds that the undertaking here is part of the transformation of procreation (and receiving of new life as a gift) into manufacturing seems to require that there is an objective, given, human nature and order of human life that must not be tampered with.  If life is God-given and humans are in His image, then it is more natural to make that kind of assertion, but by so doing I think we (I) accept the task of saying what that human nature is.  The image, in that case, needs to be more than just a “status and standard,” or to say that it grounds the human nature we shouldn’t mess with seems tautological.  Alternatively, on more naturalistic grounds, one might argue that evolution “gave” us a core genetic nature (“in its wisdom??”) that “ought not be disposed with,” a tack the German philosopher Jürgen Habermas seems to take in opposing PGD.  Or, we could even invoke a form of the much-maligned “precautionary principle” and claim that, when we start mixing and matching pieces of genomes in newly-conceived people, we don’t know what difficulties we might be wandering into, so we can’t define a risk-benefit ratio in the first place.

Anyway, I think a line something like this—there is, in a meaningful sense, a “core human nature” that must not be altered, and a natural moral law that grounds at least the most basic, primary moral precepts setting that limit—is the line that is necessary if one wants to claim that our biotechnologic grasp must stop somewhere.  And so I want to hold.  None of it suggests that the march of biotech will be slowed—it seems that somebody will try anything that becomes feasible—but it is a basis for asking people to stop and think, and getting perhaps some to turn back.  It is a basis for articulating a “presumption to forbear.”

A funny thing happened on the way to the ICU . . .

In the latter half of the last century, medical technology made huge leaps in the ability to sustain biological function. Suddenly we could replace lost kidney function and keep lungs breathing and hearts pumping for people who, but a short time before, would inevitably have died from their kidney, lung, or heart failure.

But something funny happened on the way to the ICU. These new technical means of medicine radically changed the calculus of the goals or ends of medicine. Our technical advances far outpaced our ability to think ethically about how to use our newfound abilities.

The new technological means allow us to keep bodily functions going when they would otherwise stop. For many patients, these are lifesaving and appropriate interventions. However, for others, these new treatments become treatments that treat — nothing. To put it another way, when there is some radical insult to a person’s body, the technical means to sustain vital functions such as breathing and circulation are an appropriate intervention that buys time for the body to heal in ways it obviously couldn’t if those vital function weren’t sustained, i.e., a body can’t heal if it’s dead. But there are some patients for whom death is imminent, inevitable, and no degree of healing is possible outside of a miracle. For these people, the technical means become an end in and of themselves. We sustain a person’s bodily functions, not as a means to allow any hoped-for healing to take place, but because we are able to. We may not even ask why we do it; we do it because we can. Sometimes we even think that if we can do it, we must. Thus a technical means becomes an end in and of itself.

This is one of the inevitable tendencies of technique (of which technology is a subset): the tendency to turn means into ends. If we can ethically control the expansion and use of techniques, then they can be our servants: powerful ones that we must keep a close eye upon, yet servants nonetheless. But we humans have a tendency to place faith in technology, to assume its goodness, and so to catalyze its tendency towards self-justifying expansion. To the degree that we allow this to happen, we end up serving our technology, rather than technology serving us. We end up doing things because we can: keeping the ventilator on because — well, because the patient’s on a ventilator; doing the scan or the blood test because, well, we have a patient here, and we have to do something, and we can, even if it doesn’t really serve the end of improving or preserving the health of the patient.

Of course, it is not only in the ICU that this automatic deferral to technology can occur, but in all areas of medical practice. In light of this apparent deficit of ethical reflection on and regulation of our technology, in light of the exchange of our control over technique for technique’s apparently autonomous self-propagation, I wonder whether the practitioners of the medical art are not in danger of transforming from professionals to technicians.

On (Being) “Better than Human” — Part 2

I ended my last post by identifying what I take to be an important methodological issue with Allen Buchanan’s pro-enhancement argument in his recent (2011) book entitled Better than Human: The Promise and Perils of Enhancing Ourselves. I want pick up on that point in this post, before moving on to other points of analysis in subsequent posts.

To recap briefly: for Buchanan, addressing ethical concerns regarding the “enhancement enterprise” requires, among other things, a consideration of what human nature is like. And the answer to that question, in turn, is to be found in the findings and pronouncements of evolutionary biology, as set forth in the “Darwinian worldview.” More to the point, for Buchanan, the only source of “evidence” relevant to answering the question of human nature is evolutionary biology. In other words, Buchanan’s approach here is significantly epistemically constrained—only certain sources of knowledge are considered legitimate for purposes of examining morally the enhancement enterprise. This methodological move is significant, for it has the effect of ruling out of court, from the outset, other potentially valuable sources of information regarding human nature, including, particularly, theological reflection.

The obvious question to ask here is: why accept this epistemic constraint in the first place? Presumably, a significant part of the reason for Buchanan’s insistence on this epistemic restriction is another major methodological commitment of his, to which I drew attention in my earlier posts—namely, his commitment to framing his argument in strictly secular, non-religious terms. As I have noted, Buchanan indicates (on one occasion) that he is adopting in this book a “non-religious” approach in order to advance arguments that can be “accepted” by non-religious as well as religious people. Given that methodological commitment, Buchanan presumably views the pronouncements of evolutionary biology—products of the “Darwinian worldview” to which contemporary science is (purportedly) committed, and in terms of which Buchanan seeks to couch his overall argument—as being beyond reproach, evidentially (and therefore epistemically) speaking.

What, then, does Buchanan think “modern evolutionary biology” actually tells us about human nature? In the book’s second chapter, entitled “Why Evolution Isn’t Good Enough,” Buchanan goes to great lengths to argue against what he terms a “pre-Darwinian” view of evolution, according to which “evolution is like a master engineer”— the idea that “organisms are like engineering masterpieces: beautifully designed, harmonious, finished products that are stable and durable (if we leave them alone)” (p. 27). If the “master engineer” analogy is correct, of course, it would seem to imply that we ought not to attempt to change what that “master engineer” has produced. As Buchanan acknowledges, “[i]f that’s what we are like, then biomedical enhancement is reckless indeed. Genetic enhancement—seen as an attempt to change the master design itself—seems especially ill-conceived. The master engineer analogy, if it is accurate, provides a strong augment against genetic enhancement and perhaps against biomedical enhancement generally” (pp. 27-28).

But this analogy, Buchanan says, is mistaken. Instead, he argues, “evolution is more like a morally blind, fickle, tightly shackled tinkerer” (p. 29). I will have more to say in a subsequent post regarding exactly what Buchanan means by this proposed alternative metaphor. For now, suffice it to say that the basic idea is that there’s no good reason to think that “natural selection” is currently doing a good job or that the results of evolution are “good”—either in the sense of being “beneficial” to us, or in terms of what we value as human beings—and therefore ought not to be interfered with. Evolution is, instead, more accurately thought of as being “morally blind”; the processes of natural selection are, more often than not, “nasty, brutish, and long”—displaying utter indifference to human suffering and quality of life. Moreover, rather than being a “master engineer,” evolution is more properly thought of as being a “fickle, tightly shackled tinkerer”–it operates inefficiently and frequently fails to achieve “optimal” design changes. Ultimately, Buchanan contends, “we have to steadfastly resist the common tendency to think that the latest product of the evolutionary process is the best, either biologically speaking or in terms of human values. We can’t say we are the best in either sense, and that’s why we should take the possibility of biomedical enhancement seriously” (pp. 47-48).

The bulk of Chapter 2 is devoted to defending and exploring the implications of accepting this metaphor for evolution over against the “master engineer” metaphor. A discussion of the specifics of Buchanan’s argument here will have to await another post. For now, what I want to emphasize is the conclusion Buchanan draws from this exploration—namely, that “[h]ow we think about evolution—or, if you prefer, nature—makes all the difference to how we should think about enhancement. Interfering with the work of a master engineer is one thing; selectively intervening in the work of a morally blind, fickle, tightly shackled tinkerer is quite another” (p. 29).

Or, as he puts it later in this chapter,

[t]he main point is that to come to grips with the challenges of biomedical enhancement, we need to consider it from the standpoint of evolutionary biology. Remaining stuck in the rosy old, pre-Darwinian view of nature stacks the deck against biomedical enhancement. As we’ll see in later chapters, there are a number of reasons to worry about biomedical enhancement, but the risk of damaging the work of the master engineer of evolution isn’t one of them (p. 51).

Now, to be clear: I don’t want to attempt here to litigate the creation-evolution debate—such a task would go well beyond what can be accomplished in a single blog post (or series, for that matter!). In particular, I do not intend in this post to delve into the disputes among adherents of non-theistic evolution, theistic evolution, and creationism (whether of the “old earth” or “young earth” variety). Rather, the key point I want to make here is that Buchanan’s claims about the evidentiary value of looking at (the products of) evolutionary biology actually cuts both ways, undermining his own argument as well as the position against which he argues. Buchanan wants to say that because the results of natural selection are best characterized as being, to borrow Tennyson’s famous phrase, “red in tooth and claw,” therefore we cannot say whether or not evolution is currently “doing a good job,” and therefore we cannot argue against the enhancement enterprise on the basis of an a priori assumption of a “pre-Darwinian,” “teleological” view of nature according to which our current biological condition is good and thus ought not to be (intentionally) altered. Fair enough. The problem for Buchanan now is, if the results of evolutionary biology are the only source for relevant data concerning “human nature,” this means that we also cannot appeal to evolutionary biology to argue in favor of the enhancement enterprise either. For simply looking at “the way we are” now biologically—whether that is understood as the product of unguided evolutionary processes, or the result of guided (“theistic”) evolutionary processes, or even the result of direct, special creation not involving evolutionary processes—will not be sufficient, by itself, to tell us how we ought to be biologically. After all, if our current biophysiological constitution is the result of “blind” evolutionary processes, then it is nothing more than a contingent historical accident—merely the result of unthinking, unknowing selective pressures, the consequences of which may or may not be “good” for us, and which certainly cannot be said to be the way things are “supposed to be,” in any meaningful sense of that phrase. If, on the other hand, our current biophysiological constitution is the result either of guided (“theistic”) evolutionary processes, or the result of direct, special creation—both of which would imply an intentional “design,” at least at the outset—we have no way of knowing, simply by observing our current state, whether and to what extent that state is in accordance with that original “design.” For all we know, simply through observation alone, our current condition may be very different than what was originally intended.

What these considerations highlight is the need for a broader normative framework within which to understand the significance of our current biophysiological condition and the implications, if any, that might flow from that state. We need some way of determining (a) whether or not our current biophysiological state is best understood as being a good, bad, or indifferent state of affairs; (b) whether or not attempting to “enhance” that state would be a good, bad, or indifferent course of action; and, accordingly, (c) how specific means of “enhancement” ought to be evaluated morally, in light of (a) and (b). Significantly, none of these questions can be answered simply by observing our current biophysiological condition.

To that end, theological reflection—and, specifically, Christian theological reflection—would seem to be, at the very least, a legitimate candidate for such a normative framework within which to think about and to evaluate the “enhancement enterprise.” Christian theology, in particular, proposes a coherent set of answers to such questions as who we are, how we got here, and where we are going—placing human beings in subordination to a God who designed, created, and sustains the universe and all that is in it, ordering it to His ends and for His purposes—thereby embedding human beings within the bounds of certain circumscribed limits that, arguably, are not rightly transgressed. Spelling out the details of this framework is beyond the scope of this post. The key point for present purposes is that this is the sort of framework that is needed to answer the relevant questions about the “enhancement enterprise”—crucial questions that a simple appeal to the “Darwinian worldview” cannot answer.

This is not to suggest that the Christian worldview is (necessarily) the only possible framework within which to think about these issues. Indeed, there may be numerous other possible such frameworks. The key point I want to emphasize here is that in limiting the legitimate sources for reflection on the enhancement enterprise to only that which can be said to fall within the purview of the “Darwinian worldview,” Buchanan is needlessly—indeed, one might argue, unfairly—excluding the sorts of resources that might be able to address the kinds of central questions about the enhancement enterprise that the Darwinian worldview is incapable of addressing in its own terms.

 

Works Cited:

Buchanan, A. (2011). Better than Human: The Promise and Perils of Enhancing Ourselves (Philosophy in Action Series). New York: Oxford University Press.

 

Three Stem Cell Developments

The news this past week carried three reports related to developments in stem cell research.  Briefly, starting with the farfetched and ending with the “nearfetched”:

First, the Wall Street Journal reported on efforts to “grow” human organs in the lab.   People who try to “keep score” of therapeutic results with adult vs. embryonic stem cells may recall a case in recent years in which surgeons (in Germany, I believe) fashioned a new trachea, or windpipe, for a patient using that patient’s own adult stem cells.  The current report follows this track.  In its most daring application, a heart is “grown” in the lab.  Well, not exactly: it’s not like researchers expect a clump of cells to magically take on the full, functional form of a human heart in a Petri dish.  (I’m sorry, I should be serious, but I cannot but recall my late, lamented Weekly World News carrying the front page story that Hitler’s nose had been cloned in a Petri dish—complete with a photo of the darn thing, mustache included.)  Seriously, these researches take an approach similar to the windpipe case.  They obtain a donated heart from someone who has died (i.e., a cadaver heart), and strip off all the cells, leaving only the foundation of connective tissue, the scaffold on which the functional heart cells had rested.  Then, they take adult stem cells—the idea is that these come from a patient whose heart is failing, who ordinarily would need a transplant—and place those on the scaffold, taking steps to induce the cells to differentiate into heart cells.  It’s still very early, but in concept this approach to organ engineering looks promising.  The cadaver heart need not be fresh, as it must for a transplant as currently practiced.  That means that there is no urgency to harvest the heart immediately after death, and there would be no pressure on the definition of death, and no concern about over-eager transplant surgeons jumping the gun.  Also, the “scaffold” is not particularly immunogenic, so the patient’s immune system would “see” the immunologic type of the patient’s own cells.

Now, there are years—10, at least—of research needed to find out whether this will work, but the approach appears promising.  If it does pan out, it seems to me the principal ethical issue invoked will be justice:  how much will it cost, and who will be able to get it (i.e., will we socialize the cost)?  That is for another day.

Second, a federal court let stand a decision favoring the FDA over Cytori Therapeutics, in a case involving the company’s device that allows surgeons to separate out adult stem cells from a patient’s fat.  The initial application has been in breast reconstructive surgery, and I believe the device is approved in at least one country outside the U.S.  In the U.S., however, the FDA is going to insist that the company prove, in a large, randomized clinical trial (at least one of which is in progress) that the device is safe and effective.  This places the device in a high-risk regulatory category (like, for example, cardiac defibrillators), not a lower risk category that would allow the company to get fast approval simply by showing that the device is similar to a prior, or as the FDA calls it, a “predicate” device.  (There are further nuances, because in some cases, if the risk is low enough, FDA lets a new device without a predecessor serve as its own “predicate” device, but that is too far into the weeds for this post.)  In any event, the court sided with the FDA, and the company was not surprised—this has been going on for a while.  But it is consistent with FDA’s approach to adult stem cells in general, which is that the Agency views them as sufficiently manipulated to require full-blown development, as for new drugs—even if all a doctor does is take tissue from a patient, spin it in a centrifuge to pull out the stem cells, then re-inject the same stem cells, with no other doctoring, back into the same patient.  That, in turn, is what lay behind the State of Texas trying to circumvent the FDA in recent past, to let doctors use adult stem cells in some ways for their own patients.  But the FDA will win this, in the end.  The net effect will be to slow down the availability of treatments using adult stem cells, and to make it necessary that deep-pocket companies bear the costs of the research.  On the margin, as I have blogged in the past, I think the FDA’s maybe being a bit too conservative, but “it is what it is.”

Third, the California Institute of Regenerative Medicine (CIRM), the body that was created with several million dollars’ funding a few years ago, largely for the purpose of promoting research with embryonic stem cells—which require destruction of one or more embryos to be obtained—is establishing a stem cell bank—not with embryonic stem cells, but with induced pluripotent stem cells (iPSCs) and adult stem cells derived from them.  Cells will be obtained from people with a variety of chronic diseases that are priority areas for research supported by the CIRM.  Makes all the sense in the world from the standpoint of basic and translational (applied) research.  The takeaways?  The CIRM is following the science, and not all of the research it supports is ethically questionable (although some still is, and there are other issues with how the CIRM operates that I won’t go into here).

To close, a reminder to scientifically uninitiated social conservative types:  we are not “against stem cell research.”  We are against unethical research, including research that does not adequately protect human subjects (including the unborn), wherever it is proposed.

On (Being) “Better Than Human” — Part 1

Recent posts have called for reflection on the “ends” of medicine. Though not directly addressed to the specific questions raised in those posts, this series will touch on related themes and so will be relevant to that larger discussion. With that in mind, I invite my readers and fellow bloggers to add their comments and observations into the mix, with a view toward drawing connections between these reflections and the broader questions under discussion on this site.

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As I noted in my recent posts (2/11/13 and 03/04/13), Allen Buchanan’s Better than Human: The Promise and Perils of Enhancing Ourselves is an extended argument to the conclusion that “[t]here are powerful reasons in favor of a society like ours embarking on the enhancement enterprise, and there are no objections to enhancement that are sufficient to outweigh them, at least at the present time” (p. 181). In advancing his case for this conclusion, Buchanan explicitly eschews an appeal to what he terms “religious assumptions”—not, he emphasizes, because he is “antireligious,” but because he is “trying to discuss enhancement in ways that are accessible to most people, whether they are religious or not” (p. 145). Along the way, however, Buchanan ends up committing himself to some fairly robust assumptions that may or may not be “accessible” to “most people,” especially those who approach these issues from an explicitly religious or theological standpoint. In this post—the first of a multi-part series—I want to spend some time identifying and considering the ramifications of at least some of these assumptions. We will also consider two other recently published works—Jonathan Glover’s Choosing Children and Michael Sandel’s The Case Against Perfection, respectively—with a similar objective of examining (some of) their underlying assumptions, and with a view toward bringing these works into conversation with one another.

I begin, first, with a brief synopsis of Buchanan’s argument. This will, of course, omit or gloss over many details and nuances of his argument as presented throughout the book. Nevertheless, the following summary encapsulates key elements of his larger project, points that will serve as a launching pad for reflection in this and subsequent posts. Toward the end of this post, I will very briefly focus in on a specific methodological issue, one that recurs throughout the book and which, in my judgment, renders the larger argument problematic at best. A more detailed discussion of that issue, however, will be deferred until the next post.

 

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In the first chapter, entitled “Breathless Optimism, Hysterical Loathing,” Buchanan sets out his overall objective—namely, the task of steering between the two extremes (“breathless optimism” and “hysterical loathing,” respectively) to which analyses of biomedical enhancement are frequently prone. By contrast, he aims to advance a pro-enhancement argument that nevertheless acknowledges and grapples with the risks inherent in the enhancement enterprise. In service of this objective, the first chapter provides an overview of the argument to be developed throughout the rest of the book; subsequent chapters are devoted to developing each of the major lines of reasoning to which Buchanan appeals in support of his thesis.

Buchanan opens this first chapter with the provocative statement that “It’s too late to ‘just say no’ to biomedical enhancements: They’re already here and more are on the way” (p. 3). As Buchanan notes, people already employ a whole host of biomedical enhancements. For example, some college students (particularly at elite American universities) have been known to take Ritalin to boost their cognitive performance, even though they do not themselves have Attention Deficit Disorder (ADD), the condition for which Ritalin is normally prescribed. Using a fictitious scenario in which two students at an elite American university (“Michelle” and “Carlos”) debate the propriety of this sort of cognitive “enhancement”—to which scenario Buchanan will return, in various iterations, throughout the book—he identifies two key issues that are highlighted by the fictional case scenario.

First, there is the issue of what Buchanan refers to as back door versus front door enhancements. An example of an enhancement of the “front door” variety would be if a drug were developed, approved by the FDA, and marketed explicitly for purposes of improving “normal” memory capacities. By contrast, the use of Ritalin by persons who do not have ADD, for the purpose of improving cognitive performance, would be an example of a “back door” enhancement. “At present,” Buchanan observes, “biomedical enhancements don’t come through the front door. They come through the back door, as spin-offs of efforts to treat diseases or disorders” (p. 7). Examples include the use of SSRIs (such as Prozac) by individuals who are not clinically depressed, in order to feel better emotionally; and the use of Viagra by young men “so that they can perform like the Energizer Bunny, even when they’re drunk” (p. 7). (Such is the “brave new world” we’ve inherited!)

As Buchanan notes, enhancement can also come about as an unexpected or unanticipated side effect of treatment for some condition. Modern prosthetics can, for example, potentially enable a runner to achieve faster speeds than his or her “able-bodied” counterparts (consider the controversy over Oscar Pistorius’ status in Olympic athletic competition; I will resist the urge here to pontificate on the more recent controversy that he finds himself in, except to note the obvious: “enhancement” of one sort—physical, emotional, cognitive, etc.—certainly doesn’t entail “enhancement” in the moral domain, and vice versa). Similarly, while undergoing modern laser eye surgery to correct a variety of vision problems, one can also opt simultaneously to improve or “enhance” one’s vision to a better-than-20/20 level.

The upshot of all this is that “[b]iomedical enhancements will keep coming in through the back door as long as we continue to make progress in treating diseases and disorders. So, just saying no to biomedical enhancements isn’t really an option—unless we want to stop medical progress” (p. 8). But, Buchanan goes on to say, “…if biomedical enhancements continue to come in through the back door, we’ll have serious problems.” For example, those individuals who take Ritalin to improve cognitive function (rather than to treat ADD) are taking a drug for a purpose for which it was not intended, where the safety and efficacy of the drug for that purpose has not been evaluated through clinical trials or other objective measures. These and other such “back-door” enhancements could potentially pose serious health or other hazards to individuals and/or the public at large. But “[s]o long as biomedical enhancements come through the back door, we won’t be in a good position to evaluate their safety or even whether they really work for everybody who takes them” (p. 8).

The second issue to which the “Michelle-Carlos” scenario draws our attention is the question of the relative “novelty” of biomedical enhancements, and the ethical issues raised by them, in comparison with other types of enhancements (particularly of a cognitive variety). Consider, for example, the fact that millions of us use two commonly available “cognitive enhancement” drugs on a daily basis—namely, nicotine and caffeine. Or consider some of the other major “enhancements” that, historically, have had the effect (among other things) of improving human cognitive capacities, resulting in wealthier societies and higher standards of living—e.g., “nonbiomedical cognitive enhancements” such as literacy, numeracy, and modern science; and “institutional enhancements” such as the market.

The problem, Buchanan observes, is that “…in current discourse, the term ‘enhancement’ is usually attached only to interventions that involve biomedical technologies. This blinds us to how pervasive enhancements are in our lives and how central they have been to the origin and evolution of our species” (p. 10). The lesson to be learned here, according to Buchanan, is that we need to resist the temptation of what he terms biomedical enhancement exceptionalism—“the dogmatic assumption that because an enhancement involves biotechnologies (pills, computers, fiddling with embryos, etc.) it’s somehow off the moral scale, that our ordinary moral tool kit is useless for coping with it.” Buchanan’s point is not that biomedical enhancement poses no moral challenges; rather, it is simply to observe that “human history—or at least human progress—is in great part the story of enhancement” (p.10), of which distinctively biomedical enhancement is simply one further iteration.

Of course, these observations do not stop critics of biomedical enhancement from claiming that there is something unique, something distinctively problematic about that form of enhancement over against others. Why might someone think that biomedical enhancement is unique in this way? Here, Buchanan considers four candidate arguments to that conclusion—namely,

(1) biomedical enhancements are different because they change our biology; (2) biomedical enhancements are different because (some of them) change the human gene pool; (3) biomedical enhancements are different because they could change or destroy human nature; (4) biomedical enhancements are different because they amount to playing God (p. 12).

Each of the subsequent chapters of this book is devoted to investigating and responding in detail to one of these arguments. Here, I will simply set out the broad contours of Buchanan’s response to each of the arguments; in subsequent posts, I will go intro greater detail.

In response to the “playing God” objection (Ch. 4), Buchanan argues that this really amounts to a warning against hubris—being overly confident in our technological prowess and other capabilities. As an action-guiding principle, however, it is relatively uninformative and therefore unhelpful.

With respect to the “changing the human gene pool” objection (Chs. 2 & 5), Buchanan observes that the human gene pool is always changing, regardless of what we do. The real question, he says, is whether or not natural selection is “doing a good job of changing the gene pool.” We shouldn’t assume, from the outset, that changing the gene pool would always be a bad thing. Those who do assume this a priori, Buchanan suggests, are relying on an “unsupported dogma”—namely, a “pre-Darwinian understanding of nature as teleological” (p. 16), as a consequence of which they assume “that evolution is doing a good job and that our efforts are likely to make things worse” (p. 16).

Buchanan’s response to the “changing biology” objection (Chs. 2 & 3) runs along similar lines: since “our biology is a product of evolution” (p. 20), and is therefore always changing, the salient question is “whether we might have good reasons for deliberately changing our biology in some respects” (p. 20).

Finally, in responding to the “changing/destroying human nature” objection (Ch. 3), Buchanan notes, first, that on most accounts of human nature, including Christian and other theologically oriented accounts, human nature as we know it is, at best, “a pretty mixed bag,” one that includes both “awful as well as admirable features” (21). So, prima facie, it’s not immediately clear that “human nature” is necessarily something we should even want to preserve in its present form; perhaps, instead, we should try to improve human nature so as to get rid of, or at least to ameliorate, some of those “awful” features. Arguments to the contrary, Buchanan suggests, typically rely on what he terms the Extreme Connectedness Assumption (ECA), the notion that “…if we try to ameliorate the bad parts of human nature we will inadvertently destroy the good parts” (p. 22). But why, Buchanan asks, should we accept the ECA? In deciding whether or not to accept that assumption, he says, we should look at the “evidence” about what human nature is like. What sort of “evidence” would be relevant to this inquiry? For Buchanan, the answer to that question is obvious: we should look to “scientific evidence about what evolved organisms like us are like. In other words, we have to look to biology” (p. 22).

After having (in his view) dispensed with each of these objections, Buchanan then goes on to consider two additional types of arguments: (a) consequentialist arguments having to do with the potential for distributive injustice (Ch. 5, “Will the Rich Get Biologically Richer””); and (b) a virtue-oriented objection to the effect that the pursuit of enhancement is inherently morally corrupting (Ch. 6, “Is Enhancement Corrupting?”). Buchanan believes he has answers to these objections as well, and so arrives at the aforementioned conclusion that “[t]here are powerful reasons in favor of a society like ours embarking on the enhancement enterprise, and there are no objections to enhancement that are sufficient to outweigh them, at least at the present time” (p. 181).

 

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Detailed critical engagement with Buchanan’s argument will have to await the next and subsequent posts. By way of preview, I close this post with a crucial question regarding methodology. I noted above that, for Buchanan, the only source of relevant “evidence” is (evolutionary) biology. This trope—that the pronouncements of (evolutionary) biology are the only sources of data relevant to an inquiry concerning what human nature is like—recurs throughout Buchanan’s book. (It is, of course, a common theme found in much of the contemporary bioethics literature generally.) But, as a former professor of mine was fond of saying, “why think that?” Why think that evolutionary biology is the only relevant source for information concerning human nature? What about other possible sources, such as theology and philosophy? Surely these other domains of knowledge might have something to contribute to the discussion?

This question will be the subject of my next post.

 

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Works Cited in this Post

Buchanan, A. (2011). Better than Human: The Promise and Perils of Enhancing Ourselves (Philosophy in Action Series). New York: Oxford University Press.

Glover. J. (2008). Choosing Children: Genes, Disability, and Design (Uehiro Series in Practical Ethics). New York:

Sandel, M. (2007). The Case Against Perfection: Ethics in the Age of Genetic Engineering. Cambridge, MA: Harvard University Press.

When technology limits our choices

We usually think of technology in terms of freeing us from limits, increasing our freedom, opening up new possibilities. With technological advances, we can do more, enhance our comfort, treat more diseases, travel farther, access more information, access more information while we travel farther, etc.

But every new technology also limits freedoms and diminishes possibilities. When a new technology comes along and becomes accepted and widespread, the possibility of choosing not to use that technology is diminished. Think of how difficult it would be to choose to live without electricity, running water, cell phones, the internet, cell phones that can access the internet. . .

In many cases, this is not a bad thing. We are certainly much better off because water treatment and good sanitation are so ubiquitous. But there are technologies in medicine that we have a really hard time choosing not to use, yet whose benefit is questionable at best. For instance, continuous electronic fetal monitoring (EFM) is used in about 85% of live births in this country, despite the fact that in a low-risk pregnancy the potential harms vastly outweigh any potential benefits. However, for many in the medical field, laboring a patient without EFM is almost unimaginable. Or take prenatal genetic screening technology. When I first began practice, it was offered only to women at high risk of having a baby with a genetic defect. Now, it is routinely offered to all pregnant women. The American Congress of Obstetricians and Gynecologists (ACOG) has recommended that the newest such technology, cell-free fetal DNA screening, be offered only to women at high risk; but given our inability not to use a technology everywhere we can, how long will it be before it becomes the “Standard of care,” offered to all pregnant women regardless of risk? And when the test doesn’t show a perfect baby, how hard has it become to choose not to have that “therapeutic” abortion?

The list goes on and on: antibiotics for viral infections, screening tests for prostate cancer, antidepressants for everyone who is not outrageously happy, CT scans and MRIs for — well, just about anything. In fact, the difficulty of not using technology, the compulsion to use technology even when it is inappropriate, is so rampant that 41 medical specialties have joined forces to publish lists of instances when various technologies that are currently commonly employed should NOT be used.

Reflecting on some of last week’s posts on this blog that dealt with euthanasia, I begin to wonder, What if euthanasia becomes an accepted, widespread technology, the “Standard of care”? In a culture in which we warehouse the old and dying in nursing homes, in which people who require expensive treatments in a cash-strapped system might be seen as — who often see themselves as — a “burden,” will euthanasia in such cases subtly begin to be understood as an obligation? Will the option of living with an expensive, terminal illness be limited? Will the freedom to live without euthanasia be diminished?

Journeys of Transformation

In my last post, “A Preview of Coming Attractions” (02-11-13), I signaled the start of a multi-part series of review essays covering three recently published books addressing ethical issues surrounding enhancement technologies and practices. I had intended to launch that series with today’s post. Before starting that series, however, I want to go on a brief discursus, one that will, I believe, turn out to be relevant to the themes to be touched on in the forthcoming series.

Last week, I attended the annual “Christ and Culture” lecture at California Baptist University in Riverside, California. This year’s speaker was Ralph Winter, producer of the first three X-Men films and numerous other successful film projects. Using such recent films as Les Miserables, Toy Story, Avatar, and others as illustrative examples, Winter set out, in the broadest sense, to show “how the gospel is often displayed in… contemporary film.” The unifying theme in all these stories is what Winter referred to as a “journey of transformation.” In each of these stories, the main character/hero grows through experiencing some form of adversity, learns something important about him or herself, and is transformed positively in some way.

One of Winter’s central concerns in his lecture was to explore the general question of how Christians engage with the broader culture, and particularly with how they communicate their messages to that culture. Here, Winter contends that “Christian stories often fail because we’re afraid of the journey,” by which he means that “our stories often hide from pain”—they avoid addressing the painful, the difficult, the ugly, the uncomfortable aspects of life—and place an emphasis on propositional assent over against an embrace of the “transformational journey” that is the life of faith. That is to say, there is a tendency to focus on the destination (heaven) to the exclusion of the journey that we take along the way.

What does all of this have to do with bioethics? There are at least two central lessons to be learned here.

First, in the context of genetic enhancement technologies and practices, it is worth asking the question: to what extent is the “enhancement enterprise” (broadly speaking, the attempt to “improve” human capacities by way of genetic or other interventions and/or technologies, as well as the cultural push toward embracing that agenda) in fact driven by a deep-seated, underlying “fear of the journey”—that is, a fear of those aspects of the aging process that are ugly, uncomfortable, painful, and so forth? Put more simply, to what extent is the drive toward “enhancement” really a flight from the inevitable realities of our lives as embodied creatures? (I do not propose to answer this question here; I pose it, however, as an important background issue to be kept in mind when considering specific arguments regarding the enhancement enterprise.)

Second, and more generally, our bioethical reflections—whether on beginning of life issues, end of life issues, or whatever—must always be attentive to the lived reality of embodied human existence. In particular, we must be willing to face the sometimes harsh realities of pain, suffering, indignity, and so forth, that can accompany the experience of various medical and other conditions. This is especially pertinent at the end of life, where the dying process can (but does not necessarily) involve significant levels of pain, discomfort, and distress. In a word, our bioethical reflections must tell “stories” that are true to the lived realities of human existence. If we are not willing to face these sometimes difficult realities, our pronouncements on bioethical issues are likely to seem shallow, insensitive, or even irrelevant.

This is not to say, of course, that our arguments and other reflections on bioethical issues should be overly-negative or fatalistic. Indeed, a focus on truth mandates that we tell “the truth, the whole truth, and nothing but.” This means being attentive to the fact (for example) that while the aging and dying processes can be characterized by pain, discomfort, and suffering, they are not always so characterized (indeed, with the skillful use of pain management techniques, they rarely need to be—but that is a different post altogether). The aging and dying processes can also be characterized by peace, joy, personal growth and development, and a sense of fulfillment. In a phrase: these processes can themselves be “journeys of transformation.” From the perspective of Christian theology, of course, the entire human lifespan can be understood in this way as well. The key point for present purposes is simply this: our bioethical reflections and arguments must attend to the potentially transformational aspects of the experience of pain, suffering, and the like, in addition to other considerations having to do with rights, obligations, principles, and so on.

Human life, in other words, is as much about the journey as it is about the destination. And that fact can make all the difference when it comes to bioethics.

The return of Carter’s Little Liver Pills?

 

In 1868, a fellow named Carter formulated a patent medicine and named it after himself, the famous “Carter’s Little Liver Pills.”  It turned out, amazingly, that there were few human ailments these wonderful pills could not cure: sick headaches, biliousness, torpid liver, constipation and indigestion, sluggishness . . . the list went on and on. Truly Mr. Carter was a boon to humanity.

Except that, of course, the pills did little of what was claimed. They turned out to be pretty good laxatives; everything else was advertising hype. In 1959 the Federal Trade Commission (FTC) made the company drop the word “liver” from its name, considering it false and misleading advertising.

Today the Food and Drug Administration (FDA) does most of what the FTC did for Mr. Carter’s pills. It is apparently fairly easy to design a scientific-appearing study that will prove just about anything you want it to; as my father used to say, “Figures don’t lie, but liars figure.” Poorly-designed but impressive-sounding pseudo-scientific studies have been used to foist countless frauds on a public (and medical profession) that in general does not have the sophistication to tell a well-designed study from a sham (for an example, see the now thoroughly-discredited Wakefield study that purported to show a connection between the MMR vaccine and autism — and all the people, including medical professionals, that were taken in by it). Among other functions, the FDA strives to ensure that prescription drugs are supported by reliable studies showing that a medication’s benefits outweigh its risks for its intended purposes. Drug companies are not allowed to promote their wares for “off-label” indications, that is, maladies for which there is not good evidence that the drug in question does any more than a good sugar pill would.

But this consumer-protection function of the FDA is under attack. The February 6th JAMA relates the story of a drug company and its salesman who promoted their medication for numerous off-label uses, even claiming it was safe in elderly and pediatric patients, despite the label warning specifically stating that safety was not shown in those populations. They were investigated by the Department of Justice; the drug company pleaded guilty, the salesman didn’t and was convicted. He appealed his conviction on the basis of his FIrst Amendment right to free speech. The appeals court sided with the salesman.

This case will be appealed further, so there’s no telling how it will ultimately turn out. But it is conceivable, based on this verdict, that drug companies could start making marketing claims based on pseudo-scientific sleight-of-hand that physicians and their patients might have a hard time seeing through, all in the holy name of Free Speech.

But free speech used to make false claims about potentially dangerous substances should not be protected.  Nobody likes government regulation; but when dealing with medications with a great potential for harm as well as good, I would rather trust government-employed scientists charged with protecting the common weal than a bunch of slick salesmen charged with maximizing their companies’ profits.

After the Super Bowl: Reflections on “Perfection” and Enhancement

By the time you are reading this, many of us—myself included—are (or soon will be) in full “withdrawal” mode from the “high” of yesterday’s Super Bowl. We were amazed by the awesome displays of athletic prowess on the field and caught up in the drama of watching this year’s AFC and NFC champions battle it out to the very end for the right to be called “Super Bowl champions”—the very best in the game of football, at least for a short while. Who could not have been impressed by the on-field exploits of Joe Flacco, Ray Rice, Jacoby Jones, and Colin Kaepernick? Who could not have been touched by the soaring notes of Jennifer Hudson singing “God Bess America,” or the soulful tones of Alicia Keyes singing the national anthem?

In similar fashion, we find ourselves fascinated by the accomplishment of Olympic athletes, musicians, artists, intellectuals, and others at the “top of their game,” or their art, or their craft.

Truly, these are specimens of excellence—indeed, one might say, of a certain kind of “perfection.”

Or are they?

Perhaps these NFL players, “great” as they already are, could in fact be more than what they are now—faster, stronger, more agile, more powerful. Wouldn’t that be good for the game? Wouldn’t that make the game even more exciting, more engaging, more thrilling?

Suppose, by way of a taking a pill or getting an injection—Human Growth Hormone (HGH), for example—football players could develop stronger muscles and greater physical stamina.  Would we want them to do so? Would we consider their resulting on-field performances as genuine reflections of their actual athletic abilities, or more akin to “cheating the system”?[1]

Suppose, more generally, that we “mere mortals”—those of us who are not Super Bowl champions, famous musicians, acclaimed scholars, or Nobel prize-winning scientists—could take a pill that would improve our memory, make us more intelligent, or help us feel more confident? Would this be a good thing?

And, finally, suppose we could alter the human genetic code permanently, through genetic engineering, either to eliminate unwanted conditions (diseases, genetic disorders, and so forth) or to enhance certain desired, genetically-linked traits (intelligence or sociability, for example). Should we avail ourselves of such opportunities?

In the wake of the Human Genome Project and other scientific breakthroughs, each of these scenarios is increasingly moving from the realm of “science fiction” to “reality,” a fact that should prompt us to ask—and reflect upon—a number of important philosophical and theological questions, among them the following:

  • What does it mean to be an “excellent” specimen of something (a book, a table, a human being)?
  • What does it mean to “flourish” as a human being?
  • Should we seek to “enhance” ourselves? If so, are there limits to how far we should go in pursuing enhancement?
  • What, if anything, is the value in human limitation? Are there limits that we should never seek to surpass?

In subsequent posts, we will explore some of the issues surrounding enhancement (genetic and otherwise). For the moment, as we bask in the afterglow of this year’s Super Bowl, it is worth taking a few moments to reflect on just what it is about “great” athletic, musical, intellectual and other human achievements that we find so appealing, and whether “enhancement” would render those accomplishments more or less so.


[1] The NFL is reportedly looking seriously at introducing HGH testing prior to the start of the 2013 season. See http://www.nfl.com/news/story/0ap1000000133761/article/goodell-confident-hgh-testing-in-place-by-next-season