Lies, clones, and stem cells: the language of respectable evil

A breathtaking specimen of obfuscation (or was it just plain ignorance?) was published in the Wall Street Journal (WSJ) this week. The article, entitled, “Experiment Brings Human Cloning One Step Closer,” begins, “Scientists have used cloning technology to transform human skin cells into embryonic stem cells, an experiment that may revive the controversy over human cloning. The researchers stopped well short of creating a human clone.”

A little confusing, but it sounds innocuous, no? Transforming human skin cells into embryonic stem cells: that’s the ethical alternative to cloning a human for the purpose of destroying it and removing stem cells, right? At least they didn’t create a human clone, right?

Not so fast. If one refers to the original article published in the journal Cell this Wednesday, the title alone speaks volumes: “Human Embryonic Stem Cells Derived by Somatic Cell Nuclear Transfer.” Somatic cell nuclear transfer. That’s scientist-speak for cloning.

“The achievement is a long way from creating a cloned human embryo,” the WSJ article says.

Wrong again. The article in Cell describes, and the accompanying diagram shows, a process of creating a cloned human embryo, which at the blastocyst stage is “disaggregated” (destroyed) to remove embryonic stem cells. (If the WSJ didn’t think they created a cloned human embryo, how did they think they got embryonic stem cells from it?)

Not all the press coverage was as slanted/wrong as the WSJ coverage. The BBC, for example, reported it far more clearly.

I don’t know if the inaccurate reporting by the WSJ was motivated by ignorance; or by an ideology that says that “Embryos aren’t human and if you don’t implant it and grow a baby from it it’s not a clone”; or by a desire to confuse people by semantic sleight-of-hand so that they won’t understand what’s happening until it’s too late; or a combination of all of these, or something else altogether.

But just for clarity’s sake, let me paraphrase: We have clearly demonstrated, in a respectable, peer-reviewed journal (no National Enquirer here), that we as a society are willing to facilitate the development of human beings in a Petri dish, and then, when they are at their weakest, smallest, most vulnerable and voiceless, kill them and take their body parts in the hope that they might be useful for others of their species. We deliberately kill our young: not in a gas chamber or oven, as the Nazis did; not tied to an altar, as the Aztecs or Incas did; but in air-conditioned laboratories with bright fluorescent lighting and mild-mannered lab technicians and nice watercolor paintings on the walls in our most prestigious institutions of higher learning.

God help us.

Emergent Dualism and the Sanctity of Human Life

My wife and I spent May 10-11 at the annual conference of Biola’s Center for Christian Thought (CCT), where the theme for 2012-2013 has been “Neuroscience and the Soul.”  The plenary talks are not all on the web, yet, although some are on Facebook, but a number of discussions on the general topic may be accessed here.  I encourage readers of this blog to spend some time knocking around the CCT website.

The weekend (though perhaps not the year, more broadly) didn’t have much neuroscience in it.  Most of the time was spent talking about philosophical and theological anthropology—in particular, what is the soul?  As I have previously written on this blog, I am most attracted to a “Thomistic substance dualism” (after Thomas Aquinas) of the sort advocated by J.P. Moreland of Biola, who argues that the “soul” is a simple (it doesn’t have parts) nonmaterial substantial entity that contains all the ultimate capacities of an organism and which is intimately involved in directing that organism’s development and expression of those capacities.  The word “ultimate” is critical here, because, as we all know, not all members of the human race realize all capacities at all times.  Moreland’s development shores up some shortcomings of Aquinas’s dualism (e.g., the notion that human embryos acquire souls at either 40 [males] or 80 [females] days of prenatal development), while attempting to retain its merits.  It, and other approaches that reject equating mind with brain function, appeal to certain Cartesian intuitions, like those of self-awareness, the sense of “what it is like” to have an inward experience, and others.  The philosophers call these “qualia” of mental events, which make them non-identical with physical/biologic events.  At the same time, Moreland and those of like mind reject the radical Cartesian distinction between mind and body in favor of a more wholistic, as it were, view of what the soul is and does.

Now, this fits nicely with the biblical notion of the image of God, even if one rejects Moreland’s view that the image is what man is, not just what man does (tend the earth), or the relationship between man and God, or the “status and standard” of man relative to God, creation, and the ultimate perfection man.  But I would argue that Moreland’s Thomistic substance dualism is not just faith-based, but also supported by formidable philosophic arguments and accessible on the terms of general revelation.   As such, I think it provides the strongest support available for the sanctity of individual and collective human life.  One sees this in arguments most commonly employed (perhaps not surprisingly) by Roman Catholic thinkers like Robert George; to wit, “humans are the kind or sort of being that….”

Two criticisms of Moreland’s view are:

  1. It amounts to vitalism, an otiose idea long-ago relegated to the biology’s scrap heap of history.   Moreland’s rejoinder to this is to claim that bad, old-fashioned vitalism was too crude, and that a more modern view, “organicism,” is more promising.  (I can’t carry on about that, yet.)
  2. Evolution is irreconcilable with the Thomist view of the soul, because the latter requires that genus and species not be degreed properties, but be in a real sense, immutable.  I agree that the Thomist view pushes one there, and I think that (along with Moreland, I believe), as these critics claim, the Thomist view requires one to accept that God is progressively active in creation.  But these points are said to be unacceptable because of the science of human evolution.

So, as an alternative, some philosophers who remain sympathetic to the idea that mental phenomena are not reducible to physical processes, and in fact are different in ways that cannot be fully explained by appealing to physical processes, nonetheless inescapably depend on those processes and “emerge” from them.  However, they would hold, what is emergent is not just mental properties but an actual, and in a meaningful sense, substantial self.  So they are dualists about human nature—even, in a sense, “substance dualists,” but they are less ready to allow that the human soul might exist independently of bodily life and processes—particularly those of the brain.

Now, there is more to be said about this than I can say, here or elsewhere, but it seems to me that the appeal to a “degreed” nature of life or consciousness disallows categorical distinctions of moral status between individual people, or people in general, and other beings.  (It seems to me that the emergent dualist also conceives “soul” as too readily identified with higher mental properties than the Thomist view would insist on.)  It risks making “personhood,” or “dignity” or moral status a degreed property.  Should we be more concerned about an anencephalic baby, or a fetus with Down syndrome, than a fully-endowed and functioning gorilla, and if so, why?  Should we be troubled about creating a human/non-human hybrid, and if so, why?  Would a super-intelligent robot, if there could be such a thing, potentially be a rival of “natural” humans in competing claims for concern?

I tried this out on a prominent Christian emergent dualist at the conference, and he quickly dismissed my objections.  To be fair, I hit him with a “drive by” on the coffee break, but as it happened, when I pushed, he responded, in effect, we can’t base all our moral appeals on rational argument.  Sometimes we have to just demonstrate the truth of the gospel, and show people the choice between worldviews and their consequences, and ask them what do they really prefer?  And, as unfairly as this brief post may be posing the issues, that kind of rejoinder worries me.

Ultimately, some appeal to a “givenness” of human nature is necessary to defend boundaries in bioethics.  We might indeed appeal to the naturalist by counseling caution—evolution has, over millions of years, presented us with ourselves, including our common intuitions—and we ought to have a “default” position of “no-go” on the most “out there” ideas.  We might indeed present a “two views” picture, and ask people to choose what kind of world they really want and what sort of people they ought to be.  We might argue, as I take the German philosopher Jürgen Habermas to argue, that the interplay of human autonomy, human language, and human social relationships lead us to conclude that some technological interventions would tend fundamentally to destroy who we are in community, and so ought to be avoided.  But I think it’s harder to identify, on emergent dualist grounds, what if any specific maneuvers ought to be proscribed with “thou shalt not,” or words to that effect.

The emergent dualists might be right.  (I tend to agree with Moreland that the position is unstable, tending toward either his dualism on the one hand or functionalism on the other.)  If so, we should, as the philosopher I challenged told me, follow the inquiry where it leads.  (One approach that could be called into question is Francis Schaeffer’s approach of asking whether one can live with the consequences of one’s philosophy.)  But my efforts, at least, are still awfully preliminary.

Speaking of enhancement and stem cells . . .

A recent article in the New York Times brings into focus what happens when cosmetic surgeons market “stem cell therapy” directly to consumers. In addition to capitalizing on our fears of looking our age they are grossly overstating claims regarding the effects of stem cells. What is even more disheartening about this behavior is that plastic surgeons have actually led the way in the basic science surrounding adipose-derived stem cells. I have several friends and colleagues engaged in this research and indeed there seems to be something salubrious occurring in areas where adipose-derived stem cells are transferred as a part of fat grafting.

In the field of plastic surgery we see what Steve Phillips mentions in his blog run amok. Plastic surgeons function along a continuum between cosmetic surgery and reconstructive surgery: cosmetic surgery’s goal is to improve upon normal, and reconstructive surgery’s goal is to restore what is abnormal back to normal. There are two Latin phrases that govern those different aims: caveat emptor and primum non nocere. What happens is that the cosmetic surgeon accepts the caveat emptor of the marketplace and usurps the techniques and nascent discoveries being cautiously advanced by the surgeon-scientists. With our society’s preoccupation with enhancement there is a huge demand to bring these unproven treatment modalities “to the street.”  For those of us trying to do no harm as we wait for the appropriate data on adipose-derived stem cells it can be frustrating.


The other ethical problem with stem cells

I have written about this before, but that fact that it just keeps coming up seems to warrant another go. For years much of the ethical debate about stem cells has centered on the use of embryonic stem cells in research and focuses on the moral status of human embryos and the problem of destroying human embryos for research. That is still a significant moral issue, but there is another moral issue regarding the use of stem cells that has nothing to do with embryos. The issue is the use of totally unproven treatments outside of clinical research studies.

A recent article in The Scientist reminds us that this continues to be a major ethical issue. Italy’s outgoing health minister is reported to have given authorization for the use of patient derived stem cells under a compassionate use program to some terminally ill patients against the recommendation of the country’s health regulatory agency. This is being done even though there is no evidence that there is any benefit from the administering the stem cells produced by the organization involved and no studies have been published regarding the involved treatment. Why would the Italian government choose to pay for a treatment that there is no reason to believe is beneficial in a way that nothing will be learned by doing it?

I think it has to do with some things that have become a part of the way that people in our time think about illness and medical treatment. A great many things have been accomplished by medical science just in the time that I can remember, and even more in my parent’s lifetime. We can cure many diseases that were incurable in the past. There was a time when life was expected to be short and hard and death was very present to everyone. Many of the achievements of medical science are wonderful, but they have given rise to the expectation that we should be able to cure all diseases and that we somehow have a right to be cured. Instead of realizing that we are all mortal and we will all die, we begin to think that it is unfair when we are ill and unthinkable to have an incurable illness. That makes us vulnerable to someone selling unproven treatments that benefit only the seller even to the point that we pressure our governments to pay for this type of unproven treatment.

We need to remember that the common fate of all human beings is death, and all of medical science is unable to change that. Every person whose life is saved by a new amazing treatment still eventually dies. We should not be blind to the reality of death. The response to incurable illness needs to be compassionate care for the life that those who are dying have left, not the false hope of unproven cures that accomplish nothing.

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.

A Couple of Other Bioethics Blogs Worth Checking Out

“Merry Christmas to all, and to all a good night….”

I am mailing it in on the holiday.  To do so, I thought I’d encourage readers of this blog to check out at least two other bioethics blogs that may not always be linked in the usual places.

One is Wesley Smith’s “Human Exceptionalism” blog at National Review Online.  Posts are reasonably frequent (although none in December 2012), with an emphasis on human dignity concerns (end-of-life, distinguishing human and animal moral status), biotechnology and risks of commoditizing human life, and the implications of the Patient Protection and Affordable Care Act (aka “Obamacare”).  Conservative, both socially and politically, as I take conservatism generally to be understood in today’s America.

The other is the “Over 65 Blog” at the Hastings Center website.  Organized by Daniel Callahan and colleagues, this blog focuses on reflections by senior citizens on health care, health policy, and generational issues raised by those and by the aging of our population generally.  The five stated goals are “a stronger role for seniors, self-determination, more care/less technology, confronting the cost problem, and the economic and family needs of the over-65 generation.”  The general perspective is more progressive or at least center-left.  Last week brought a really interesting post from Alicia Munnell, a management professor at Boston College, refuting the idea that older people working longer will mean taking jobs from the young.

I think both are thoughtful and authoritative, and welcome respites from the talking-point fiascos of broadcast journalism.

Ethical problems with how stem cell research results are communicated

Stem cell research was back in the news recently with a CBS news report titled “Paralyzed patients regain some sensory function after neural stem cell treatment.” Unlike the study that I wrote about back on 1/25/12 which used embryonic stem cells, this study did not have any serious ethical concerns in itself. The study which was done at the University of Zürich involved implanting neural stem cells directly into the spinal cords of three patients paralyzed by spinal cord injuries as a part of a phase 1 trial of the safety of such treatment. The stem cells which were implanted were adult stem cells that would raise no ethical concerns. The treatment was tolerated by all three patients with no apparent adverse effects, which will allow the researchers to proceed to further studies. This preliminary phase 1 trial was being reported at a London meeting of the International Spinal Cord Society. All of that was quite appropriate.

The ethical concern has to do with the focus of the news report and how the information was reported by the company sponsoring the research. Since this was a phase 1 trial on just three patients the focus of the study was on whether the treatment caused any adverse effects, and in the limited number of patients studied it did not appear to cause any problems. However, the focus of the article was on two of the three patients regaining some sensory function at levels beyond the level of their spinal cord injury. Because this was a phase 1 trial and was not a study designed to establish any therapeutic affect there was no control group and any reporting of therapeutic effect is purely anecdotal. There is no way to know whether any apparent improvement in sensory function was independent of the treatment, was a placebo effect, or was a result of observer bias. However, Dr. Stephen Huhn, a neurosurgeon and the vice president and head of the CNS program at StemCells, Inc. focused on the improvement in sensory function of two of the three patients in the study.

If Dr. Huhn understands the scientific process he knows that the only thing that can be concluded from the study is that there were no observed adverse effects of the treatment on a very limited initial sample of patients, which allows further studies to be done. He knows that nothing can be concluded about whether the treatment is effective or not. As a physician he also knows that reports of possible benefit from a new treatment will raise the hopes of spinal cord injury patients in a way that may be unfounded. So why would he report on benefits of the treatment seen in the study not designed to detect benefits? The incentive to do so appears to be financial. As vice president of a private corporation that depends on investors to fund research it is tempting to report results that do not have a scientific foundation to enhance investor interest. Ethical scientists need to resist that temptation and report the results of their studies accurately and without sensationalization of unproven results.

Embryos from laboratory produced eggs

The London newspaper The Independent recently reported that a researcher at Edinburgh University is ready to seek permission to try to produce human embryos by the fertilization of mature egg cells that have been produced from ovarian stem cells in the laboratory. The research team has taken immature human egg cells produced from ovarian stem cells by as researcher at Harvard and transformed them in the laboratory into cells that appear to be mature human eggs. The proof that they are mature eggs will be obtained by showing that they can be fertilized to produce human embryos. The embryos will then be frozen or destroyed since they are being produced for research and English law requires that they not be allowed to develop past 14 days.

The obvious ethical question is “Should we do this?”

Those who support doing this see the ability to develop fully functional human eggs from the stem cells found in the ovary as a way to provide the ability to have children for women who are past the time that their ovaries naturally produce eggs. They also express hope that the ability to produce new egg cells might be a way around the loss of ovulatory function that is associated with the development of menopause and its attendant problems. It would also be a way of producing a much less limited supply of eggs to use in research including cloning.

But should we do it?

Ethical concerns abound. Is it worthwhile to create and destroy human embryos to prove that a scientific technique is doing what it was designed to do? Is there any way to determine whether children born with the use of eggs developed from stem cells in the lab are at increased risk for defects without subjecting some children to those risks? How could you justify doing safety studies on children produced by this technique who could not give their consent? Would attempting to delay menopause by inducing the production of new eggs within aging ovaries be a good thing to do? Is it really good to make it easier to do things like human cloning?

For those of us who conclude that human embryos have full moral status it is clear that producing human embryos in the laboratory to confirm that this technique is successful and then destroying those embryos is wrong. Even those who do not think that human embryos have full moral status have reason to think that this is not a good path to start down from concern about the safety of the people who could be born using this technique.

This is one of those things we should not do.

Exaggerated response to a limited clinical study

A preliminary report was published online on 1/23/12 in Lancet about the first two patients in safety studies of injecting retinal pigment epithelium cells derived from human embryonic stem cells into the eyes of patients with different kinds of retinal blindness. What can be concluded from the studies is that no tumor formation or rejection was noted in these two patients four months after the injections. That is not enough information to make any conclusions about the safety of this treatment and safety is the only thing these studies are designed to assess. There are some who have questioned why such limited data would even be published, but the headlines in the press were amazing. They ranged from “Early Success in a Human Embryonic Stem Cell Trial to Treat Blindness” (Time) and “Blindness eased by historic stem cell treatment” (New Scientist) to “Embryonic stem cells: can we make the blind see?” (Forbes).

Why would very limited initial results from preliminary safety studies have such an exaggerated response? Part of it undoubtedly has to do with our culture’s desire to find miraculous cures in science. In fact the Forbes article says “Restoring sight to the blind is, literally, a miracle…when the cells inside the eye are damaged, there is nothing we can do. Until now.” Another part may be due to economics. These studies are being funded by a private company, Advanced Cell Technologies, which stands to benefit from any positive publicity. The company’s Chief Scientific Officer, Robert Lanza, was quoted in the New Scientist article emphasizing the improvement in the vision of one of the patients. The studies are not designed to assess the effectiveness of the treatments to improve vision and vision was only measured to look for deterioration as a possible side effect. One of the other researchers involved noted that the other patient was found to have some slight improvement in vision in both of her eyes, even though only one was treated, suggesting any improvement was due to the immunosuppressant drugs used or a placebo effect.

Scientific discoveries can at times be very beneficial, but we need to take very preliminary studies such as this one as what it is – preliminary. We should not induce false hopes in people with retinal blindness that they are going to be cured. We should not forget that there may be some studies and treatments that should not be done, such as those which require the destruction of human embryos when other methods for deriving retinal pigment epithelial cells could have been used.

A busy week for stem cells

Two bits of news from the world of stem cells this week:

First, Geron, the California company conducting the first ever official study using embryonic stem cells in humans, has suddenly terminated the study. Geron cited economic factors as the reason for stopping the trial. The study involved spine injury patients; Geron said only that the therapy was well tolerated, with no serious adverse events.

Second, a study using “adult” stem cells from patients’ own hearts to repair their own damaged heart tissue has produced promising results. The study’s purpose was not to show that the use of the cardiac stem cells was effective, but to make sure that the process is safe (the Geron study was also a test of safety); but study subjects receiving their own stem cells have already shown improvement in heart function.

Daniel Heumann, of the Christopher and Dana Reeve Foundation, said of the halted Geron study, “I’m disgusted. It makes me sick. To get people’s hopes up and then do this for financial reasons is despicable. They’re treating us like lab rats.”

The authors of the adult stem cell study, while warning that the results of the trial needed confirmation in larger trials, called the initial improvement in cardiac function “very encouraging.”

Geron has invested tens of millions of dollars in embryonic stem cell therapy in the past decade.

Even if one does not believe that it is unethical to destroy our offspring to find cures for our diseases, one should at least acknowledge that spending tens of millions of finite research dollars for an agenda that repeatedly uses reckless hype to gets people’s hopes up, only to dash them, is an unethical option when compared with funding “encouraging” research with a proven track record of producing successful treatments.