Bioethics, Policy, and “Barking Up the Right Trees”

I suppose I should apologize for writing—now and before—so much about matters related to fiscal policy on a bioethics blog, but the line between them can be blurred when it comes to medicine, bioethics as a field tends to expand its own reach (excessively in my view), and, at the moment, in this election season, fiscal policy is sort of an 800-pound gorilla.

Plus, my attention today is seized by the comments of Bill Gross, the “bond king” from PIMCO, about the “fiscal gap” and the peril it presents to our nation. Briefly:
• The nation’s current total debt is $16 trillion (all numbers approximate in this post);
• The future obligations under Medicare, Medicaid, and Social Security, as they now exist, amount to an additional $60 trillion;
• The Congressional Budget Office, the International Monetary Fund, and the Bureau of International Settlements’ projections imply that, rather than just reduce our budget deficit of $1.2 trillion, we need to cut spending and/or raise taxes to the tune of $1.6 trillion per year, starting soon (as in, now), to get our national debt under control. The alternative is for our central bankers to print money until it’s worthless, and the economy collapses—not in the next presidential term, but in the next generation (10-20 years).

Oh—full expiration of the “Bush tax cuts” would yield $200 billion per year, and the “budget deal” that was said to be so close in 2011 would have yielded $400 billion per year. That is, chump change.

I’ll try to stop soon with the numbers, but if this year’s spending were where Mr. Romney says he will aim (20% of the GDP), that would have “saved” (I try to use the word advisedly, because of the emotional/political overlay of these discussions) $700 billion. If tax receipts were where Messrs. Simpson and Bowles suggested we should aim (21% of GDP), that would have brought in another $750 billion. Getting closer, but not there (but leaving a deficit lower than the 3% of GDP maximum urged by the Secretary of the Treasury). If the current, historically high federal spending ($3.7 T, 24.6%) pertained, total tax receipts would have to have been $4 T instead of $2.4 T, or 26.7% of GDP. Unheard of in our history.

Now, full disclosure: I’m sort of a Paul Ryan fan. But I do believe I am open to “compromise,” and yet, with all the bipartisanism (and grace) that I can muster, it seems to me plain on its face that the U.S. government simply must spend less on health care going forward. I want to believe that approaches like Mr. Ryan’s offer prospect for real reform. On the other hand, “Medicare as we know it” (a rhetorical phrase that spikes my blood pressure) will, if not substantially changed, collapse in my likely lifetime. Or, as Mr. Gross fears, the country will.

Mosey on over to the Hastings Center’s “Over 65 blog” and one can read poignant and thoughtful posts about the physical and financial frailty of old age, alongside rhetorical flourishes against the likes of Ryan, written by Dr. Theodore Marmor (public policy professor emeritus from Yale, single-payer advocate). To be fair, I need to dig deeper, and I’m going to try to study Dr. Marmor’s arguments in a recent “point/counterpoint” series on Medicare reform. But from the little bit I’ve read so far it seems that the most thoughtful people’s positions are entrenched enough that compromise is out of reach not just of our politicians, but of our populace in general.

For the moment, my thought is that the predominant “bioethical” issue for the foreseeable future, at least in the U.S., may be how on earth, if we indeed go “off the cliff,” to handle the care demands of my generation. I wonder if it won’t make worrying about matters like stem cell research and human enhancement seem like luxuries.

And it seems to me that much thinking about this—including several of my past posts on this blog—fail to begin to address the deep shock that will be coming to how we live out our days, how we view our earthly estate, and how Christians can lead the way.

Inspirational Sports Stories and the Values behind Life and Death Decisions

We fret—rightly—on this blog about the values that inform decisions to pursue or not pursue extensive, risky, intensive, and maybe expensive treatments for severe conditions on the “ends of life.” We’ve written about dismissive attitudes toward the disabled, the escalation of some non-life-threatening conditions (e.g., Down Syndrome) to make them hard barriers to treatment, and so on. We worry, as we must, that a functional view of human moral status will be used, too quickly and in a “blunt object” fashion to create and implement rules that would deny treatment unfairly to those among us who are weak.

One source of correctives against this is sports television. We all know about Oscar Pistorius, the Olympic “blade runner.” (I know he raises issues about enhancement, but I cannot see him as anything but a courageous overcomer when the conventional wisdom would have been to write him off.) But consider also Matt Woodrum, an 11 year old with cerebral palsy, featured on ESPN SportsCenter on Aug 26, 2012. All he did was run, and finish, the 400 meters at his school. When he was a neonate, his parents were told they should have made him a DNR. He had been born three months’ prematurely, with brain hemorrhage. The prognosis was grave for him and his twin brother. In case studies, one might have made an argument for withholding treatment. Or consider Jen Bricker, featured on HBO’s Real Sports with Bryant Gumbel, Episode 184 (registration required to view fully on the Web). Jen was born without legs, and abandoned at the hospital by her parents, who didn’t even bother to name her. She was raised by a saintly couple in a tiny Midwest town. They told her never to say “can’t.” She became a gymnast, a champion tumbler. (She also played softball and basketball (!)) Oh, and she turned out to be the sister of Olympic gymnast Dominique Moceanu.

The point is, especially at the beginning of life, to not give up on people, and to require that medical injury be catastrophic indeed even to consider giving up early. We can consider, as I have suggested on this blog, that in old age we might be wise to forego some treatments in some circumstances, but we should have an extremely powerful bias toward treatment early in life, when earthly possibilities still lie ahead. This bias should recall, as I’ve written before, that “million dollar babies” are not a cost-driver for our health-care finance problems.

Sure, after a reasonable trial of treatment, it may be time to withdraw, but the bias should be strong enough that we don’t have to worry, as Joel Belz does in the current issue of World magazine, that the IPAB or some such body will just declare that kids with Down Syndrome don’t get their congenital heart problems fixed. It just should not even cross our minds.

Should We Pay Bone Marrow Donors?

Wanting to write about something different this time…

Every now and then the general press reminds us about an ongoing controversy: should donors of bone marrow—or, more precisely, the early blood cells that are found in bone marrow and are highly useful in certain medical treatments for serious illness—be paid for their donation?

It’s a tricky area. Marrow cells are more like whole blood, plasma, or sperm, in that they are renewable, than they are like organs (your kidneys, heart, or liver) which are not. Agree or no, some blood, plasma, and sperm donors (and, indeed, egg donors) are paid for their trouble. In the U.S., the FDA regulates what’s done with the harvested tissue or cells, and mandates (in the case of blood) that, if a donor was paid, the harvested material is labeled to that effect. The one-day surgical procedure of repeatedly sticking a big needle into the hip bone to get bone marrow is increasingly being replaced by a 5-6 hour process of, as it were, filtering the desired cells out of a person’s blood, and re-circulating that blood back into the person. More is involved, and there are side effects (rarely severe). Still, while the procedure may not be “entirely benign” (to crib from the Perri Klass title), it’s hardly draconian.

Of course, transfusion and transplantation medicine suffer from donor shortages.

And consider that healthy volunteers for studies of experimental drugs are routinely compensated—sometimes to the tune of a few thousand dollars to be in a one- to two-month clinical trial—to cover not just time and inconvenience, but also to recognize that they are voluntarily placing themselves at some degree of risk. IRBs are charged with certifying that those risks are minimized, but they aren’t zero, and some of these volunteers make a living at it as “professional” research subjects.

When it comes to compensation, I’m inclined to think of marrow and blood donors as more akin to those drug-study volunteers than to organ donors. (I do recall that all analogies are flawed, so I don’t mean to press this one TOO far.)

It seems to me that it’s not unethical on its face to compensate marrow donors beyond, say, reimbursing travel expenses. The clearest ethical issues seem to be related to undue influence—would payment prompt someone to take foolish risks, would the profit motive (wherever it sits) swamp any regulatory efforts to be sure that the specimens obtained are safe to use in someone else, would the disadvantaged be preyed upon? These could, in principal, be addressed. Still, there’s significant risk on all three counts. Add to that the objection of the Bone Marrow Registry program—that non-volunteer donors would be more likely to withhold medical information about themselves that would otherwise evade testing but put a recipient at risk—and there are plenty of reasons, on grounds of benefit/risk or justice, not to pay marrow donors.

Beyond that, I am uncomfortable with the underlying perspective that seems to treat the body as a source of something not just to be used, but to be bought and sold. It’s a little disingenuous to be too dogmatic about that, because there are costs to an all-volunteer program. (Those costs might be unfairly shifted in a pay-to-donate approach, say, if a marrow program had to come up with the money to pay the donors.) Still, I think that, on these grounds alone, I prefer the all-volunteer approach.

Primum non nocere. I would not encourage anyone (e.g., a cash-poor seminary student) to donate marrow as a money-making proposition. (Indeed, I wouldn’t encourage anyone to be a healthy drug-study volunteer.) And we need to draw the line somewhere. If we pay for marrow, where does it end? Can we be sure we won’t be pushing to pay for kidneys?

Disability, Dignity, and the Insidious Push for Death

I am sure I should find a better title for this post but I cannot resist the provocative…

If you are not aware of it, make your way over to the website of the Hastings Center Report and the Hastings Center’s Bioethics Forum blog and look, on the main site, at William J. Peace’s article “Comfort Care and the Denial of Personhood” (July-August 2012 issue) and, on the blog, the invited responses to it. Mr. Peace, a paraplegic since 1978, wrote a deeply disturbing account of his encounter with a grim hospitalist who, for all intents and purposes, pressured him to forego antibiotics to treat an infection, on the grounds that the gravity of his underlying and overall condition, and the potential risks—worst-case scenario and otherwise—just weren’t worth it, and if Mr. Peace chose it, he could forego antibiotics and be kept very comfortable in his dying. Of course, Mr. Peace’s disability was construed as a life-threatening illness, which it was not. The patient was, understandably, horrified, as should we all be.

The commentators on the Hastings Bioethics Forum shared this horror. In the process, they decried a general insensitivity on the part of physicians and society at large toward disabled persons; the fragmentation of medical care as currently practiced; a certain overaggressiveness on the part of transplant physicians seeking donated organs; an impatience with intensivists and other physicians in too much of a hurry to declare certain comas irreversible; and a pervasive pressure for patients and their surrogate decision-makers to agree to forego interventions of all sorts for a variety of reasons, among other things. I found little, if anything, to disagree with in these responses to Mr. Peace’s article.

Oh, and they were concerned about a certain tone-deafness of the bioethics community toward the worries and distrust that disabled people live with routinely vis-à-vis the medical “system.”

[And, on the way, they even spoke of “dignity”—that “useless, stupid” concept that I thought mainstream bioethics had dismissed as a reactionary canard wielded like a club against the unsuspecting by knee-walking, knuckle-dragging troglodytes in fealty to the church, the Bush Administration, and other assorted enemies of enlightenment. But never mind that….]

By all means, go and read these—they are thoughtful and, I think, helpful. My two cents in further comment:

1) We are so inured to the notion of a health care “system” that the momentum it has engendered will make the “physician-patient dyad” (as a separate piece in Hastings put it earlier this year) increasingly irrelevant. Physicians employed by hospitals or public entities or other bodies, responsible more for resource-based decisions than the patient’s needs, held to rigid guidelines promulgated from afar, will be more likely to act as agents of someone other than the patient. The separation of the executioner and the healer is being undone, as Margaret Mead feared. An urgent need and opportunity for the church will be to find a way to help people defend themselves against the “system.”
2) For fans of the so-called Affordable Care Act: this is a big reason why some of us fear the IPAB. We don’t trust them. Are we, perhaps, tarring with too broad a brush? Perhaps. But on what evidence might we be persuaded to do otherwise?
3) Ditto for the regrettable over-reaction two years ago about “death panels.” In that, doctors saw hostility toward appreciating their efforts to discuss with their patients some difficult care and end-of-life decisions. Some in the public saw a commandeering of the timing and nature of those discussions. Again, trust—or lack thereof.
4) As I grow older, I am increasingly suspicious of the organ transplantation industry. Why, did you notice that Dr. Robert Truog wrote to the Wall Street Journal back in March that he has not signed his organ donor card?
5) In all of this, I agree with Steve Phillips and Jerry Risser in their reflections about moral agency and moral status.

More on the pro-PAS rejoinder in the New England Journal of Medicine

Today, by way of agreement, I’d like to add my two cents to Steve Phillips’s post of July 19 about the recent NEJM article proposing to sanitize, as it were, physician-assisted suicide (PAS) by trying to spare physicians from providing lethal drugs.

[I should write about something unique, and relegate this to a comment on Steve’s post, but I have been working on a presentation for my church on end-of-life issues, so I’ve been dealing with this topic recently.]

First, the authors of the NEJM piece “spin” the Oregon Death With Dignity process a bit promotionally, in my view. They describe it without any of the cautionary concerns raised by, for example, the CMDA. Check out the “Standards 4 Life” tab on the CMDA website; the worries raised there are not included in the NEJM article’s description.

Second, the authors claim to have dispatched five of the six “primary” objections to PAS. Palliative care is better, they point out. (OK, but it can improve more.) Oregon is not dispatching the vulnerable; most PAS requestors are white, educated, and affluent. The number of requests (30-50 per year) is not increasing, and the eligibility is not being broadened, so they consider “slippery slope” arguments mooted. Nobody is getting coerced in Oregon. And sanctity of life, they say, is subjective, and a PAS option for some would not affect “those who object.”

And, (the sixth objection), given the large majority of physicians who object, the NEJM article proceeds in bad faith, by appearing to suggest a solution that respects physicians’ conscience: doctors just have to provide the diagnosis and prognosis of a terminal illness. A “central state or federal mechanism” (note the impersonal wording!) can do the rest. In fact, as Steve smelled out, they are circumventing doctors’ care for their patients.

Leon Kass cited three “dangers” to a “right to die” in his 2002 book Life, Liberty, and the Defense of Dignity. I think they still apply:

1) “A right in aid-to-dying will translate into an obligation to others to help kill.” In this case, the state becomes the euthanizer. “God forbid,” Kass said. Someone—someone anonymous to the person making the request—will have to provide this “help.” These people will be bureaucratic executioners. I can imagine someone making parallels to capital punishment here, but PAS would not be an example of the state wielding its just powers of retributive justice. Physicians would be pushed into complicity, as would be government employees, taxpayers, etc. And, by the way, if you think you are a right to be made dead, that does not mean you have a right to oblige me to help you.

2) There will be “no way to confine the practice to those who knowingly and freely request death.” Reassurances about Oregon are cold comfort. Prevailing trends toward limiting moral status based on active, realized capacities will drag us toward frank euthanasia, and we can predict pressures to make decisions “for” comatose people, or pressures on depressed or burdensome folks to send in the government paperwork.

3) “The medical profession’s devotion to heal and refusal to kill—its ethical center—will be permanently destroyed…here is yet another case where acceding to a putative personal right would wreak havoc on the common good.” Steve nailed this one in his post.

Space does not permit me to rehearse Kass’s arguments why the “right to die” is incoherent. Suffice to say that it is contradictory to suggest that the language of rights, which assumes life and choices, can support a “right to be made dead,” which obliterates both.

Most certainly, a PAS option for some would affect those who object. And sanctity of life is anything but subjective; rather, it is grounded in quite objective arguments about reality and assumptions necessary even to discuss right and wrong.

I had been thinking that PAS was not so much of a front-burner issue recently. The NEJM authors say “[m]omentum is building for assisted dying.” Is it, now? I am not so sure, but I am reminded not to doze off.

Suing FDA over Directed Sperm Donation?

I guess it’s modestly interesting…

You may have seen the recent news item that a woman, who wants to conceive using a directed sperm donation from a male acquaintance, is suing FDA, presumably, if the media reports are to be believed, because “the Agency” is preventing the donation from happening. She is quoted in some circles as saying that she does not want to be “forced to have intercourse” with the man. In others, it is said that she does not want to pay to have him tested for communicative diseases. It seems like the latter is probably closer to the real issue. At first, I thought she had a compelling argument. After a little digging, I don’t think so.

As I noted in my May 29 post on adult stem cells, FDA regulates human cellular and tissue-related products pretty closely. This includes requirements that “any establishment that performs one or more manufacturing steps” for these products register with FDA, list their products, and satisfy FDA that the steps they take to process the cells or tissues don’t do something to them that would increase the risk that they could harm a recipient of the product.

In the case of donated reproductive cells, FDA requires that establishments test donors of anonymous or directed (emphasis mine) sperm or eggs for several diseases: HIV (types 1 and 2), Hepatitis B and C, syphilis, gonorrhea, chlamydia, and, for sperm, viruses called CMV and HTLV (types I and II). At least some of this testing is subject to the qualification that it is required if the donor and recipient “are not sexually intimate partners.”

If establishments don’t comply, and FDA finds out, FDA may send them a “warning letter,” which is one step short of FDA showing up and padlocking their door and shutting them down. It seems like FDA issues such a warning letter to sperm/egg donation centers every month or two, usually for failure to do the testing.

So it seems to me that nobody is telling this woman she may not have a directed sperm donation from her acquaintance. The reasoning appears to be that, once a third party is involved in handling the sperm (or eggs, the same issues apply), that third party assumes responsibility for preventing the spread of sexually-transmitted disease in the process.

Note that a more elusive issue—whether the donor might have other genetic diseases that pose risks to the eventual offspring—is not raised in this case.

I don’t know for sure how this plaintiff will do in court, but on principle I don’t like her chances.

Of course, I and probably most readers of this blog would reject artificial insemination-donor (AID) overall, on moral grounds, so there would be no issue. And as I read the regs, the same restrictions may not apply in exactly the same way to artificial insemination-husband (AIH).

As I said, minimally interesting. Poorly reported in the press—but they needed a headline, I guess.

Trying to understand medical benefits and harms

I am at the annual meeting of the Drug Information Association (DIA), a group of drug development/clinical trial professionals, in Philadelphia. Among the sessions are discussions about how to get a more rigorous assessment of whether one medical treatment works better than another—called comparative effectiveness analysis (here, CEA)—and whether the risks of some things like new drugs are worth it (called risk-benefit or harm-benefit analysis). Both are of great interest, and involve challenging efforts that can be easily misunderstood in places like the general press. Some key points:

This is hard—the techniques are being worked out and involved sophisticated mathematical analysis to do things like weighting (as in, is a 50% chance that your migraines will get better in a few hours worth a 1% greater chance you’ll get a heart attack over the next 10 years? How relatively important are those two?), and sensitivity analysis (do we get the same results if the weightings, or the chances of different outcomes, change?).

You can get a different answer depending on who you ask—One great idea in benefit-harm analysis is to ask patients with a disease what they would prefer. Some studies work on that principle, by surveying patients. Patients tend to be more willing to take risks than doctors (“first, do no harm,” and by the way don’t get sued) or regulators (avoid the nasty Congressional inquiry and press coverage if someone decides you approved a risky drug). But both types of groups need to be approached.

The judgments are value-laden, so a single, precise mathematical answer will be elusive if not impossible, but the information gained can help inform reflection and decision-making. There will be a risk to conclude too much. But I bet that much enlightening information can be gleaned.

Techniques are not standard and so it’s hard to get reproduce findings. But every new “study” will be trumped by the press as definitive. Take your medical reporting with a grain of salt.

What you find depends on what you look for—which means that taking time to define the research question carefully is important. Also, once you find something, you tend to assume that you are right in future inquiries.

Note that none of this brings cost into the equation, yet. In fact, some of the work is funded by the ‘stimulus package’ and the ‘Affordable Care Act,” both of which prohibit using funds for cost-effectiveness analysis. That will come but is not the whole schmear.

This work will go forward, and provide a lot of useful data, I bet. There will also be a great risk that results will be overinterpreted, people will jump to conclusions, and there will be a great concern that decision-makers are doing too much with the results. Still, this work is to be followed, viewed soberly, and not overly feared.

“Search and Destroy” by Stealth?

Last week’s publication, “Noninvasive Whole-Genome Sequencing of a Human Fetus,” by Kitzman et.al. in Science Translational Medicine, does not represent a Rubicon-crossing so much as a next logical step. It raises the well-described ills of devaluing unborn human life and the “soft eugenics” of parents attempting freely to choose their children’s biological characteristics. These issues were promptly addressed by seasoned observers such as Wesley Smith and the New York Times’s Ross Douthat.

Your intrepid correspondent paid the $15 for the article online and must report that he’s technically over his head, but that it is clear that this is a tour-de-force made possible by rapid gene sequencing and serious math/computer power. It’s also crucial that, as it turns out, DNA fragments float free in the bloodstream, and that up to 10-13% of that in a pregnant mom’s blood comes from the baby in the womb. That means that all of mom’s genes can be sequenced from her blood cells, all of dad’s genes can be sequenced from DNA obtained from his saliva, and when the information obtained from sequencing the free-floating DNA in mom’s blood is combined with these, predictions can be made about whether the baby might be affected with any one of about 3000 single-gene diseases. Then, when the baby is born, baby’s DNA can be sequenced—and the prediction turns out to be 98% accurate. Um—wow.

It’s all subject to the usual biomedical yada-yadas—it’s expensive for the moment, it needs to be validated, it was on a single case (actually two, but the article focuses on one)—but with refinements it will be here to stay.

Until now, this kind of prenatal diagnosis has required an invasive procedure—for example, amniocentesis—in which a sample is taken directly from the womb during pregnancy, with risks to the developing baby (and to a lesser extent, to mom). Oldsters like me will recall the 1980’s when Dr. C. Everett Koop—Christian, staunch defender of the unborn, Surgeon General, and pediatric surgeon extraordinaire—declared amniocentesis a “search and destroy mission,” because results were typically used to inform an abortion decision, not to prepare for the care or treatment of the baby on the way. So it seems with this new technique. It looks like the main application is to identify individuals who will not be born because of some genetic disease they will have. That’s happening now with Down syndrome (a chromosomal, not a single-gene, condition), but the use can be broadened.

So why did these scientists do this in the first place? There seems to have been no purpose other than to facilitate the abortion decision. Maybe there are future cures that this very early diagnosis will someday facilitate, but it seems terribly hard to guess at that—or at the value of pre-natal as opposed to immediately post-natal diagnosis. Besides the well-known considerations about embryofetal moral status and reproductive autonomy, it seems to me that this is another example where it is increasingly important to question the ultimate goals of scientific inquiry. Knowledge may not always be an unqualified good and is less and less pursued for its own sake, it appears to me. Certainly this paper was solely about technology.

Where might it lead? Personally, I doubt some sort of state-mandated use. Rather, a “consumer-oriented” regime seems more likely in our society. And will people use it to predict more complex traits? That also seems far off—the interpretation of the data would be prohibitively complex and expensive. But those computers are getting more powerful….

We have another occasion to say, “We shall not.”

PS—I was due to post yesterday, but got behind. But thanks to Dr. Jerry Risser for a terrific post on veterinary vs medical covenants.

A Brief Update on Adult Stem Cells

Readers of The New York Times and other news outlets may have seen the May 17 announcement that Prochymal, an “adult” stem cell-related therapy to treat children with graft-versus-host disease, was approved in Canada by Health Canada (which is what they call their FDA up there). This treatment, which is made by a company called Osiris Therapeutics, is being tested for other medical conditions. Success does not appear to be uniform, which is to be expected. Most new medical treatments fail in at least some envisioned applications.
Graft-versus-host disease is a complication of transplantation—usually, as in this case, bone marrow transplant—in which immune-competent cells in the donated graft attack the tissues of the recipient. A little bit of this may be tolerable or even desirable, medically speaking, but too much is not pretty. The cells in Prochymal are so-called “mesenchymal” cells, derived from bone marrow. That is, they are in the marrow but are different from the cells, also in the marrow, that are destined to make mature blood cells. They are obtained from healthy adult bone marrow donors and are made into a treatment that can be prescribed “off the shelf,” so you don’t have to find new donors every time you want to use them. That is a neat technical feat.
Recall that somatic or “adult” stem cells are found in different tissues of the body and have different abilities to be transformed into some other kind of cell. They can’t make a whole individual. Readers of this blog will recognize them as the “good guys” of stem cell research and therapy.
This treatment is not yet approved in the U.S. I suppose it might be in the future. It seems to have followed a pretty standard scientific, ethical, and regulatory paradigm for the development of new drug and biologic treatments.
Most, but not all, adult stem cell treatment involves stem cells that specifically exist to form blood cells, for use as bone marrow transplants. These cells can come from a donor’s bone marrow, or they can be filtered out of the blood stream, where they circulate, or, increasingly, they come from umbilical cords. These historically have been used by medical centers as a procedure, but central banks are arising to procure, store, and provide them. Accordingly, the FDA is regulating them more and more as products like drugs.
There is ONE such adult stem cell product approved by the FDA—Hemacord, which consists of umbilical cord cells. There are late-stage trials seeking to establish that adult stem cells from bone marrow are useful in treating heart failure, for example, but to my knowledge final results are not yet available.
There are also a number of efforts to use people’s own adult stem cells for them—for example, in plastic surgery. FDA regulations require that this use be limited to cases where there is “minimal” manipulation of the cells, and the threshold for “minimal” is being fairly hotly disputed. If it is exceeded, FDA asserts substantial control over the efforts—at substantial effort and expense for the practitioners. I believe this is what much of the recent hubbub in Texas over adult stem cell treatments is about, but this blog is not big enough to delve deeply here.
I will say I think we should be careful about “scoreboards” of successes with adult vs embryonic stem cells. I find them misleading at best. If we are counting individual cases, that is not the same as approved therapies, and the number of individual successes is probably too low on the adult side without including the thousands of successful bone marrow transplants.
But in this context, the application of adult stem cells still appears to be expanding, and milestones like regulatory approvals should be noted by those interested in this area. And that, of course, is before we start talking about newer approaches, like iPSCs, to more “juvenile” stem cells.

Whoa, Robot

This week’s many events include these three: I watched the movie I, Robot for the umpty-umpth time; the FAA announced it will make it easier for domestic agencies (e.g., the police) to fly unmanned drones in the U.S.; and the Wall Street Journal ran this article by Dr. Jonathan Moreno from the University of Pennsylvania: “Robot Soldiers Will Be a Reality—and a Threat.”
Dr. Moreno—well-known to readers of this blog, through Heather Zeiger’s recent series of posts—worries deeply about the confluence of neuroscience and military technology. Some conceivable applications of bleeding-edge neuroscience threaten individual autonomy and public freedom, and write the questions of justice in large letters. As skeptics of human enhancement point out, what is to prevent some future enhanced being, humanoid or not, from taking over from us people? The “dual use” problem—that technologies may be used for good or ill—poses, at the extreme, existential risks to the human race, risks so great that they render “risk/benefit” analysis useless. (Dr. Moreno also made this last point in 2010, before the Presidential Commission for the Study of Bioethical Issues, regarding synthetic biology.)
Brain-machine interface technology, that could help paralyzed people control artificial limbs with only their thoughts, could not only be used to dominate an enhanced human soldier’s mind (as Heather pointed out), but also to permit humans to oversee weapons systems that are increasingly autonomous. Even now, automated systems (without the human brain interface, to be sure) are on duty in the Korean DMZ. But more sinister still is the prospect that experiments in quantum computing will lead to robotic warriors based on “whole brain emulation,” capable of making attack decisions that are out of the control of humans. They could be used to attack innocent people, ignoring the laws of war and honor.
It calls to mind the dystopian logical conclusion of I, Robot’s three laws, and Dr. Lanning’s musings that “free radicals” of code could spontaneously at least mimic the actions of the soul (like intention and self-awareness). The deep questions of philosophy of mind aside (for now), Dr. Moreno recommends lots of urgent international negotiations, of treaties, rules, laws, verification systems, human overrides, and the like. He also argues that “fully autonomous offensive lethal weapons should never be permitted.”
He’s right. And yet, for starters, we have a much more “nearfetched” problem at our door: if we allow unmanned surveillance drones flying around our communities, even in the name of only watching for the bad guys, we accept the use of an instrument of war over our people. Let’s start by banning that. It’s tempting, when we look at the places where the police seem outgunned, but we should advocate a ban on domestic drones, as well. (What’s that, guns are also an instrument of war? Not like drones, they’re not—anybody hunt deer with a drone?)
To get around to it, my points: 1) It is time now to stand, on a lot of fronts, and say “we shall not”; 2) Support Dr. Moreno’s negotiations, but realize that no set of rules will buy complete security, that bad actors will persist, and that the situation is so complex that useful rules will be elusive (how’s that Dodd-Frank regulation writing going?); 3) Aggressively defend the so-called “medical boundary”—technology should be used to heal disease, not do “extra-human” things. It’s not a bright line, but a useful concept nonetheless; 4) Accept—and here’s where it gets really hard—that there is such a thing as a normative, or essential, human nature, that establishes boundaries that ought never be violated (probably a position inaccessible in any meaningful way to the atheist/naturalist); and 5) Consider moving the “ban boundary” into the laboratory. In this case, why should we be doing experiments in quantum computing? What legitimate, God-honoring purposes are being served? The scientists should be pressed, hard, to articulate goals.
In the meantime, I wonder if I should take cover….