On the Aging and Passing of the “Francis Schaeffer Generation”

In his fine post yesterday, Jerry Risser wrote that he is “certainly not a proponent of fighting the culture wars of the 1980s and 90s.” He then went on to say that on critical moral issues, we must stand firm. It seems that a loud and growing majority agrees, in a sense, with the first statement, by saying “you social and religious conservatives just go away.” One writer on National Review Online suggested religious conservatives on “on the verge of a new Babylonian Captivity.” These sentiments clearly complicate attempts to stand firm as Jerry exhorts.

My wife and I, who were in our 20s when President Reagan was elected, tended to interpret “faith in action” as activism in support of the “life issues,” notably abortion, to which American Evangelical Protestants had been awakened, albeit belatedly, by the work of Francis Schaeffer, in particular. We are in the “Francis Schaeffer Generation” as much as the “Reagan Generation.” In his book (with Dr. C. Everett Koop) Whatever Happened to the Human Race? (and working against a background of 20th century totalitarianism), Schaeffer urged us to be appropriately alarmed and outraged, and to act constructively. And he warned us against taking lazy solace in “personal peace and affluence.”

Now, the Francis Schaeffer Generation is getting old. Some of its mightiest warriors are dying off (Schaeffer and Chuck Colson, for two, are with the Lord). It’s being told it’s out of touch.

But far be it from me, a nameless foot soldier in the “culture war,” to suggest or admit defeat. To be sure, an angry, clenched-fist, condemnatory stance does not honor Christ or communicate love and respect. But in a world where an unpopular stance on moral issues is considered hatred on its face, no one should bear any illusion that the culture war is over. The secularists will press their advantage. Consider, for example, on abortion: why is it treated not just as a matter of choice but as a public good? Why is any attempt to discourage it labeled as a “war against women?”

What should we foot soldiers do? How about:
1) Double down on Schaeffer’s principles. He was right.
2) Support the leaders and people and organizations on the “front lines.”
3) Recruit, support, and gently persuade emerging leaders of the new generation, who, unlike fossils like me, are “in touch.” This includes future political candidates.
4) Realize that there is still a place for good-old-fashioned litigating and legislating. For example, I read remarks by Richard Doerflinger to the effect that legislative protection of certain conscience rights may be feasible, such as with riders to larger bills that would not be likely to be vetoed.
5) Support “emotional,” “narrative-based” approaches as Jerry suggested. There is an army of emerging, imaginative workers, particularly in the performing arts, who should be encouraged to craft high-quality cinema and other works that engage audiences more thoroughly and gently than “Christian” films that amount to cinematic Evangelical sermons, as nice as these may be.
6) Realize, as Jerry pointed out, that thoughtful, rational arguments can still carry the day. Did we all notice that Massachusetts rejected physician-assisted suicide—by a narrow margin, to be sure—last week, and that some of the most eloquent positions to that end were articulated by people like Dr. Ezekiel Emanuel who cannot be mistaken for religious conservatives?
7) “Change the water.” Recall the old joke about the two young fish who swim past an older one, who asks them, “How’s the water?” They respond, “fine,” then swim on a bit before one asks the other, “What’s water?” We must be aware of the “water we swim in,” and question and seek to change cultural assumptions, where necessary. It seems to me this goes on in our extended families and on our streets, in conversation with people closest to us.
8) Learn about, and teach our kids about science and proper scientific reasoning. Jerry pointed out that “good science” should be embraced. But by that we must mean not only science pursued ethically (e.g., iPSCs vs embryo creation and destruction to get ESCs), but also science done well and honestly, and appropriately interpreted. Anecdotes—even a lot of them—added up and posted on a “scoreboard” do not substitute for properly controlled clinical trials, and we must remember that there is profiteering going on with some uses of adult stem cells, and there have been some cases scientific fraud committed in iPSC research. Examples not to be overemphasized, but they are out there.
9) Above all, pray for God’s guidance and for his truth to prevail, trust His sovereignty, and obey Him as fully as possible, with His help.

“3-4-50,” Bioethics, and the Church

In bioethics, we focus—necessarily, I suppose—on rules and principles to address concerns at the boundaries of human life. Compelling as this may be (How shall we limit the mischief committed in the name of progress? How shall we forge a “grand solution,” if one is even accessible, to ensure that everyone gets the medical care he needs?), I sometimes wonder whether we are barking up the right trees—or, maybe I should say, barking at branches while the trunk rots.

In partial response, I give you Dr. Nick Yphantides: disciple of the Lord Jesus Christ, Chief Medical Officer for San Diego County, and brother of one of the elders of my congregation. He describes how our “health care” is really “sick care” for preventable, lifestyle-related conditions. While many have commented on this, Dr. Nick’s formula is simple—3-4-50:

o Three behaviors—poor diet, lack of exercise, and tobacco use—lead to
o Four diseases—cancer, heart disease, Type 2 diabetes, and lung cancer—which cause
o Fifty percent of deaths—in San Diego and the U.S., and the world (at least, the industrialized world).

Whatever other arguments we have about medicine, ethics, economics, and politics, if we would attend to the “three,” we would do ourselves a lot of good, make ourselves healthier in the balance, and probably dramatically lower the costs of our “sick care.” We can debate that last point, and expensive medicine will not go away overnight, but changing the three harmful behaviors seems common sense about which there is broad agreement.

Oh, by the way, Dr. Nick used to weigh 467 pounds. Now he weighs 194. It’s all described on his website, HealthSteward.com, and his book, My Big Fat Greek Diet. (Note that if you Google on “healthy stewards” you can also pull up websites addressing fitness.)

All well and good—but is there a specifically Christian take on this? I worry about “Christian” approaches that seem more faddish than theologically grounded. My grandparents’ Christian bookstore used to carry a title, The Fat is in Your Head (I think Revell was the publisher), and who can forget the exercise video “Firm Believer” (get it?) from the 80’s?

Well, Dr. Nick’s testimony is that the Christian approach is both simple and foundational—be a steward of the health of the gifts our God-created bodies are. He starts with Jesus’ admonition to the Pharisees to “clean the inside” first, and the outside WILL follow. From there, Dr. Nick proceeds to ground seven “pillars” of health stewardship in love and gratitude. Read more about this on his website and in his book. HealthStewards is a specific ministry for Dr. Nick—“Building the kingdom through shrinking the body,” as he tells me in an e-mail.

It seems to me there is a legitimate Christian stance by which we, in recognition of who we are as God’s creatures, joyfully encourage each other and those outside our community to live more healthily—starting from youth. I think such a stance is gentle and grace-based, not legalistic; that it steadfastly AVOIDS stigmatizing anyone; that it encourages moderation while avoiding some sort of asceticism while also reminding ourselves that gluttony and sloth are two of the Seven Deadly Sins; that it fosters a culture of “personal best” rather than pursuit of some ideal, especially of fitness or beauty; and that it admits of some freedom on the margins (I’m in the Presbyterian Church in America, or “PCA,” which, as the joke goes, stands for “pipes, cigars, and alcohol [or ammo].”)

Two final points, for now: First, I’m terribly ambivalent about the proper scope of government paternalism over all this. I am sympathetic to restrictions on smoking but find Mr. Bloomberg’s limits on soda sizes misguided, for example. Second, while it is tempting to start discussions of “3-4-50” with the costs of “sick care,” I think the usefulness of that approach is limited. Less Type 2 diabetes means less expense to control blood sugar or treat the complications of diabetes, for sure. But coronary bypass and colonoscopy and the latest drug for breast cancer may still be relatively expensive in the U.S., for one, and for another, I read that knee replacements for active seniors are becoming a cost-driver for Medicare.

What do you, readers of this blog, think about all this? For the moment, it’s off to the gym for me. I’m 6’3” and 220, making me 20 pounds overweight by BMI. And I wish, at age 55, that I was built like an NFL safety. Sooooo not gonna happen….

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.