Paying for oocyte donation—California’s governor vetoes AB 926

On July 18, I wrote at length on this blog about AB 926, which had passed both houses of California’s legislature.  I was pleased to learn that California’s Governor Jerry Brown vetoed it on August 13.  Governor Brown, a progressive Democrat, can hardly be considered a pro-life conservative.

He based his reasoning on the issues of informed consent that I (and others) have described.  In my opinion, the key graph of his veto message is:

“In medical procedures of this kind, genuinely informed consent is difficult because the long-term risks are not adequately known.  Putting thousands of dollars on the table only compounds the problem.”

This of course keeps the reasoning fully focused on autonomy, and does not address the other major moral issues at stake.  But the governor’s decision is still the correct one, and wise.  At a minimum, it slows the freight train a bit.

You can read the entire concise veto message here.

Sex and the Single Robot: part 1

Once upon a time in the context of course work we were asked a poignant question, prompting much reflection: do we control technology or does it control us? After weeks of reflection during my morning runs and commutes I concluded that technology’s control was conditional upon one’s dependence upon it. While that conclusion is true as far as it goes, the more I read and am informed of life outside of rural Wisconsin, the more I become aware of the naiveté of that perspective. My most recent enlightenment has come from reading Alone Together: Why We Expect more from Technology and Less from Each Other by Sherry Turkle, a book that has prompted me to think that the book Sex and the Single Girl by Helen Gurley Brown—a book that inaugurated the sexual revolution in the early 1960’s (information I possess not by familiarity with the book but through the use of a technological search engine)–is in need of a 21st C update; hence the title.


In Alone Together, Turkle references David Levy’s 2007 book Love and Sex with Robots: the Evolution of Human-Robot Relationships in which he advocates the virtues of relationships with–and even marriage to–robots. By mid-century, he claims, “love with robots will be as normal as love with other humans…” Moreover, he claims that robots won’t fail where humans do—no cheating, no heartbreak, no “fake orgasms” (although it is unclear why a pre-programed act would be preferable to a response “faked” for the fulfillment of another), not to mention, more control. Levy’s single narcissistic criterion for judging the worth of robots is “does being with a robot make you feel better?” But can a relationship with a mere “performance tool” teach us intimacy and authenticity?

Robots that were designed for instrumental purposes—to do for us, like searching out land mines and sweeping our floors—have infiltrated the child’s playroom and long term care facilities for the elderly as sociable objects—to be there for us and with us, as objects of mutual affection. As Turkle acknowledges, “…when we are asked to care for an object, when an object thrives under our care, we experience that object as intelligent, but, more importantly, we feel ourselves to be in a relationship with it.” It is only a short step to robotic intimacy, especially for those offered this form of intimacy during their formative years.

Technology is indeed seductive. I was recently a delegate to a national convention numbering in excess of 1500 people. While the directors had the foresight to disallow any form of electronic communication on the floor, the proceedings were projected on two large screens at the front of the stage for the benefit of those in the back of the large room. My assigned seat was in the second row from the stage, yet I found myself drawn to the vibrant, dynamic, larger than life persona projected onto the screens rather than the personal presence before me. How much more seductive is technology when it meets our human vulnerabilities?–and we are indeed very vulnerable. We maintain a pretense of hundreds of voyeuristic Facebook friends, yet we remain ensconced in loneliness, for despite our loneliness we fear intimacy and authenticity. As Turkle states, “Technology offers us the illusions of companionship without the demands of friendship.”

It is maintained that through intimate and even sexual relationships with robots we can learn to be better friends and lovers. But this is based on the erroneous assumption that our sexuality and sexual performances are the epitome of intimacy–that human sexuality is the “be all and end all” of human relationships. But in desires for self-gratification, we have transformed a unifying, other-centered act of love and procreation into a self-centered performance art. Perfecting sexual performance through practice on an object does not translate into enhanced personal friendship and intimacy. Quite the contrary, through our interactions with an objectified “other” we will merely learn to treat others as objects and subsequently come to understand ourselves as objects, as well, a fact incongruous with the notion of relational self-improvement.

We have come to navigate intimacy by dodging it. It was once said that “the eyes are the windows on the soul,” yet we increasingly avoid eye contact with others, being distracted by the “demands” of our technology. But if we would perchance look into the eyes of a robot, what would we see? Where is the soul? What Winston Churchill said about buildings is true of all cultural artifacts, “We shape our buildings and then they shape us.” We create our technologies, our robots, and they, in turn shape us, remaking ourselves and shaping our intimacy with each other through intimacy with machines. Whether our ventures into technology involve communication or physical and psychological intimacy, we must ask ourselves what we are losing in the midst of our “gains,” and whether it is too great a price to pay. As social beings, our personal identity is forged in the perichoretic dance of selfhood, a reciprocal encounter of the self and the other, ideas of Paul Ricoeur that will be explored in the next installment.


Love a robot? Silly, you say? Try losing your smart phone…

On Myriad Genetics and Withholding Information

Mutations in the BRCA1 and BRCA2 genes confer an increased risk of many types of cancer. In 1995, Myriad Genetics patented the BRCA1 and BRCA2 genes which it had successfully sequenced and isolated, giving the company an effective monopoly on testing for mutations in these genes. However, Myriad’s achievement rested on many other shoulders: in 1990, US researchers first began to zero in on the BRCA1 gene, and in 1994 UK researchers first located the BRCA2 gene. Last year, Myriad made $500 million; most of its profits came from the BRCA test,which typically costs $3,000 to $4,000, putting it well out of the financial reach of many women. In June of this year, the US Supreme Court ruled that naturally-occurring genes cannot be patented; almost immediately, another company announced that it would offer the BRCA test for $995.

After the Supreme Court ruling, Myriad’s president and CEO stated that “we remain focused on saving and improving peoples’ lives and lowering overall health care costs.”

In the meantime, Myriad maintains a database of the information it gained from nearly two decades of testing millions of women. Until 2005, Myriad shared that data with the National Human Genomics Research Institute’s Breast Cancer Information Core, an open-access database of information that helps researchers understand breast cancer genetics. However, since 2006, Myriad has withheld its BRCA data — data that it generated by charging 250,000 women annually thousands of dollars a test.

Dr. Robert Cook-Deegan, a research professor at Duke University’s Institute for Genome Science and Policy, is cited in an article in this week’s JAMA arguing that the data Myriad is withholding might help improve cancer care of prevention. “The easy thing to do would be to behave like most other laboratories and share the information,” he said.

Not just the easy thing, but the ethical thing. In another article in the same issue of JAMA, Dr. Harlan Krumholz of Yale University School of Medicine is quoted as saying, “Science cannot be self-correcting if only some of the data are available to only some of the people.” Just as naturally-occurring genes cannot be considered proprietary per the Supreme Court, so population data that is potentially important for human health should not be considered proprietary. It is not clear why Myriad is withholding its information; some speculate that it hopes to leverage the data for profit. Maybe such a strategy makes good corporate business sense; it is not consonant with ethical scientific practice, and does not square with Myriad’s stated focus on “saving and improving peoples’ lives and lowering overall health care costs.” If Myriad is really interested in “saving and improving lives,” even if it doesn’t bring in lots of money for the company coffers, it should make available the data it has gathered from millions of patients. As Cook-Degan said, “Women paid for those tests — and paid premium dollars.”

 

The information for much of this post came from the article “Supreme Court Tules Agains Gene Patents,” published in the July 24/31 issue of JAMA, p 357 (Vol 310 No 4), available for free here.

Human Flourishing: It’s in the Eye of the Beholder


In my last blog, on the eve of presenting the fruit of a year and a half study on human flourishing from a biblical perspective at CBHD’s conference “Health and Human Flourishing,” I shared some insights gained from that study into the role of suffering in human flourishing. This week I would like to share one other insight gleaned from the biblical perspectives on flourishing before moving on to other topics; and that is, how flourishing is to be defined or evaluated.

One approach to the definition of human flourishing was developed by Carol Ryff (1989) who systematized various views of optimal human functioning into six dimensions of psychological human well-being: purpose in life, environmental mastery, autonomy, personal growth, positive relations with others, and self-acceptance. To these six psychological dimensions of well-being Corey Keyes added five dimensions of social well-being–social coherence, social actualization, social integration, social acceptance, and social contribution—to yield a composite and complete measure of the flourishing life—a life that is filled with positive emotions and is functioning well psychologically and socially.

An examination of Scripture, however, yields an alternative insight: human flourishing is not by human definition or design, but is a manifestation of God’s divine purposes and plans for our lives. Human flourishing, like beauty, is in the eyes of the beholder, and the only proper beholder is God. As the source and telos of human flourishing, He is the only one with a proper perspective, who knows the end from the beginning, who can understand and anticipate all the consequences of our valiant, yet feeble attempts to flourish. Human flourishing, therefore, is to be evaluated and judged, not from an anthropocentric perspective, but from a theocentric or Kingdom perspective. As His creatures, and because human flourishing is an intentional act of God in blessing his human creatures, flourishing must be defined and understood from His perspective. From that theocentric vantage point flourishing is not measured by long-life, material prosperity, or even shalom as personal well-being, but by being set apart to accomplish the good deeds He has planned for us in this world. It is discovered in walking with God and is measured not by material possessions or visual analog scales, but by righteousness as a relational concept, the fruit of which is a harvest of gratitude and even greater righteousness, the resources for which are provided by God Himself. Such godly favor does not necessarily bring a life of prosperity and ease, as we discovered in my last post, but often of even greater challenges, as witnessed in the lives of those who were said to have found such favor (Noah: Gen 6: 8-9; Moses: Ex 33: 17; Mary: Lk 1: 30). Hence, flourishing from the perspective of God may not be consistent with what we would envision and may at times be incongruent with what we desire. For just as with the thoughts and ways of God are not ours, the plans and purposes of God for our flourishing transcend our objective and subjective limitations.

If true human flourishing is an intentional act of God, is contingent upon a relationship with God, and is defined by God’s purposes and plans for humankind, this raises the question: can humans flourish apart from God? This question can be answered affirmatively with qualifications: all human flourishing is by the gifts and grace of God who sends rain on the righteous and unrighteous alike, and who is kind to ungrateful and evil men, which can be all of us at times. Human flourishing apart from relationship with the source of that flourishing—human flourishing that is perceived to be by one’s own hand, and not the hand of God—is a testimony to the incredible grace and glory of our Creator. But flourishing without a proper heart orientation toward both God and material possessions is ultimately momentary and transient, bearing no lasting fruit. Flourishing that is enduring is oriented to God, His glory, and His Kingdom.

Paying for oocyte donation—update from California

A number of concerned groups in California are encouraging citizens to urge Governor Jerry Brown to veto AB 926, which has passed both houses of the state legislature.   AB 926 would repeal a provision in the California Health and Safety Code that prohibits compensating women who donate their oocytes (eggs) for research purposes.   Wesley Smith has blogged against it, arguing that it would “permit Big Biotech to buy eggs from poor women to conduct human cloning and other experiments.”  One Leah Campbell, a past egg donor and author of a book entitled Single Infertile Female and an eponymous blog and website, writes in the San Diego Union-Tribune that AB926 “aims to turn women’s bodies and ovaries into an assembly line.”

What is going on?  It merits some unwinding.

In 2004, California passed Proposition 71, which established and provided $3 billion in bond funding for the California Institute for Regenerative Medicine (CIRM), to support basic and translational stem cell research.  The proposition explicitly cited human embryonic stem cell research as a major priority.  (In fairness, CIRM funds all things stem-cell, including somatic, or “adult,” stem cell research, and research with induced pluripotential cells [iPSC’s].)

As the California Senate’s analysis of the bill (available here) points out, at the request of the CIRM the Institute of Medicine (IOM) issued a 2007 report assessing the medical risks of oocyte donation for research.  Those risks included ovarian hyperstimulation syndrome (OHSS) which can have serious medical consequences in 1-2 of every 1000 stimulation cycles; risks of the procedures involved; psychological risks; and unknown but potential increased risk of some cancers.  The IOM pointed out that the stimulatory treatments needed for oocyte donation, when used in fertility treatments, are largely self-regulated by the medical specialty society involved, the American Society of Reproductive Medicine (ASRM), and the associated Society for Assisted Reproductive Technology.  Further, there is no ongoing registry of oocyte donors in place to observe women systematically, over time, for medical outcomes.  (This in the age of “evidence-based medicine.”)

Accordingly, in California law: “No human oocyte or embryo shall be acquired, sold, offered for sale, received, or otherwise transferred for valuable consideration for the purposes of medical research or development of medical therapies. For purposes of this section, ‘valuable consideration’ does not include reasonable payment for the removal, processing, disposal, preservation, quality control, and storage of oocytes or embryos” (Section 125350 of the California Health and Safety Code).  AB 926 would not change that part of the law.

However, in accordance with the sorts of concerns identified by the IOM, California law has prohibited paying egg donors more than the actual direct costs of the procedures (the “removal, processing, etc.”).  That is, women should not be charged for the medical and research procedures involved, but they shouldn’t be paid extra for their time and trouble, out of concern that such extra payment would constitute an unacceptable inducement to donate, and amount to impermissible exploitation.  This is what Ms. Campbell (and Mr. Smith, and to be candid, I) am concerned about.

Now, AB would repeal this specific prohibition, and allow this extra compensation of women who donate their eggs for research.  There are a couple of wrinkles:

First, as noted, the language prohibiting payment for the oocytes per se (or for an embryo) would not change, and new wording is provided to put a fine point on that.

Second, the bill tries to distinguish between donation specifically for research and donation for infertility treatment.  How?  To begin with, the rationale for the bill is that we already accept compensation for subjects of medical research, particularly for early clinical trials of experimental drugs given to healthy volunteers.  Such compensation can reach well into four figures per study, leading the phenomenon of the “professional research subject” who serially volunteers for these studies and tries to make a living off the compensation for participating.  Such compensation is for the subject’s time and inconvenience, and the consent form usually says so in so many words.  This is standard practice in research ethics, and there is a substantial body of literature (and ongoing debate) around the merits or harms associated with this practice.  The argument for AB 926 is that it would just treat women who donate their eggs for research like other research volunteers.  Further, without the compensation, people won’t volunteer.  (That is a safe assumption, based on the experience with drug studies in healthy volunteers.)  And, since much of the research is sponsored by industry, Wesley Smith is, in a sense, correct:  industry is not paying for the eggs proper, but they are paying for enhanced research participation.  I leave it to you to judge whether this is a distinction without a difference.

How much compensation is too much?  That is for Independent Review Boards (IRBs) to decide.  AB 926 affirms that the IRB must make this judgment in the case of compensation for women who donate their eggs for research.

But what about women who donate eggs for infertility treatment?  AB 926 tries not to be about them.  But if there are “extra” eggs—eggs that an infertile woman deems, with her doctor, she doesn’t need for her attempts to have a baby—then, if the clinic harvesting the eggs belongs to the Society for Assisted Reproductive Technology, then the IRB “shall disregard” the matter of compensation.

Got that?  The further wrinkle is that, according the California Senate’s analysis and the IOM report, while ASRM endorsed this sort of compensation for women who donate eggs for infertility treatment, it said that “total payments to donors in excess of $5000 require justification, and sums above $10,000 are not appropriate.”  Yet it is common knowledge that these payments can be much greater than that.  But in that case, AB 926 tells IRBs, “never you mind.”

Ms. Campbell (see the Union-Tribune link above) wrote that the aftermath of her egg donation included severe pain from endometriosis related to the ovarian stimulation, and, in a cruel irony, now she is herself infertile.  Her story reminds one of “Eggsploitation.”

So what to say of all this?

  • A decade after Prop 71, the commodification of the egg donation process, in the name of supporting research with created embryos, is a reality.
  • If I were on an IRB evaluating a proposal, it would be a lively meeting:
    • The egg donation is likely primae facie unethical because it supports the fundamentally unethical act to create or destroy human embryos solely for research purposes;
    • Compensation to the donor would have to at least fall within the ASRM dollar limits as described above; higher amounts should be viewed as an unacceptable inducement;
    • The required description of risks to the donor in the consent form must make the risks of severe complications of OHSS, and the lack of data on long-term risks, starkly evident;
    • I would argue strenuously that two basic requirements of IRB approval of the research—that risks are minimized and that they are commensurate with the benefits of the research—could never be met.

This one had flown under my radar, and I now need to send a letter to the governor.

Human Flourishing in the Face of Suffering

In early January 2012, I learned that the title of this year’s bioethics conference was to be “Health and Human Flourishing,” which set my pondering wheels in motion. Human flourishing is a term that has been conscripted into service in the bioethical community—particularly the Evangelical bioethical community–in recent years as a semantic alternative to the Aristotelian notion of “eudaemonia”–“the Good” or “Happiness”–both which have been corrupted in contemporary vernacular. The term has been offered as a framework for understanding and conceptualizing our approach to technological innovation in order to positively promote progress in the health and well-being of the human community, but it’s content is seldom defined. Even in the book Health and Human Flourishing: Religion, Medicine, and Moral Anthropology, a collection of essays edited by Carol Taylor and Robert Dell’Oro (Georgetown, 2007), the meaning of the term is assumed, not defined. But what is flourishing–what does it mean to flourish? How does one flourish? And in particular, how are we, as Christians, to understand flourishing? Querying others outside the ethical and bioethical arena yielded a general response of cluelessness: most seemed unfamiliar with the term, let alone the concept. This launched a one and a half year journey through Scripture in search of a biblical perspective on human flourishing with which to frame and fill the content of the concept.

While the fruits of that labor and journey will be presented at the conference, I want to share a particular insight here. One note that resonated clearly throughout Scripture, although more loudly in the New Testament, is the relationship of suffering to flourishing. Suffering, in Scripture, is not incongruent with flourishing; in fact, not uncommonly, flourishing is by way of suffering. This paradoxical fact is made explicit in Mt 5: 10-12 where those who are persecuted, slandered and insulted are said to be blessed. In this passage, it is suffering that is acknowledged and allowed by God. But in other passages, that suffering is seen to come directly from the hand of God: suffering in the form of discipline or chastisement (Rev 3: 19); suffering that is evidence of God’s love (Prov 3: 11-12); suffering that ultimately leads to flourishing (Job 5: 15-26). The purpose of God in such suffering—pastorally referred to as “pruning”–is to bring about repentance and proper orientation to the Law or Word (Ps 94: 12-14; Ps 119: 71) and to produce holiness and fruitfulness in our lives—fruits of righteousness (John 15:2, Heb 12: 10-11). Suffering therefore keeps us on, or returns us to, the path—the εὐοδόω, or good way– that leads to our ultimate fulfillment, to a fuller revelation of God Himself.

This relationship of suffering and flourishing is contrary to contemporary culture where the old motto “no pain, no gain” has been modified to fit its new conception of the good life: “no pain, no pain.” It is also the orientation of most of biotechnology whose primary objective is painless immortality—the elimination of pain, suffering, and death at all costs–which is objectively measured by quantity of life and visual analog scales. There is no room in such objective calculations for consideration of flourishing as a subjective and relational reality, or for the fact of pain and suffering as means of flourishing, leaving the secular notion of flourishing at odds with the Scriptural concept. Yet it is often suffering that leads us to Christ whereby we can be healed and consequently flourish.

Biotechnology offers us a portrait of human flourishing distinct from that of Scripture, one that entails a “different gospel,” offering us the hope of freedom from suffering and death through technology and biotechnical means. Such freedoms stand in opposition to the role of suffering demonstrated in scripture where suffering is often a means to flourishing. This new gospel of flourishing proclaimed by biotechnology is not grounded in a dependent relationship with a Creator God but in the self-sufficiency of human creativity and ingenuity, in the power, strength, and determination of our will. It is an ill-conceived notion of human good that sees that good as devoid of pain and suffering; it is a gospel for which the means are justified by the ends, the ends of our choosing. Biotechnology, when employed for purposes of self-glorification and salvation is a thief who has come to kill and destroy, whereas abundant life (flourishing) comes from Christ.

This does not require that we reject all that biotechnology has to offer. Human flourishing is not exclusive of health, longer life, ease of life or material prosperity, for God is a God of mercy and redemption, who gifted and enabled us to redeem some of the consequences of our own sinfulness. What is necessary is a proper orientation toward God in the midst of biotechnological pursuits, a discernment of His purposes and plans for human flourishing in this world and the role that biotechnology might play in those purposes. It requires an understanding of the limitations of biotechnology and the positive role of suffering can play in our lives. For God enables our flourishing when we have turned from and been cleansed of the idols, especially the idol which is the work of our own hands. But it is God who is the source of our flourishing–our “eudaemonia”–and not we, ourselves. And it is God who confirms and gives permanence to the work of our hands.

On (Being) “Better than Human” – Part 3D

With apologies in advance to my readers for the length of the recent posts in this series, I finish up here my critique of Allen Buchanan’s argument in Chapter 2 of his Better than Human. This chapter contains a great deal of theoretical machinery, which machinery will prove central to Buchanan’s argument in the rest of the book. For that reason, I have spent considerable time on those details in the last few posts, with a view toward proceeding more economically through the respective arguments of subsequent chapters. I beg the reader’s indulgence.

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First, as we have seen, Buchanan prefers to think of evolution as being more like a “morally blind, fickle, tightly shackled tinkerer” than a “master engineer.” He makes much in particular of the fact that evolution is “morally blind,” using the cruelty of nature—both in the way it selects against certain traits and in the way it selects for other (“beneficial”) traits—as a point of departure for pontificating on the Problem of Evil (pp. 37-39), which he defines as follows: “Given how much human suffering there is in the world—much of it utterly undeserved—how could such a world be the creation of a being that is both all-powerful and supremely good?” (p. 37).

In this context, Buchanan contends that Darwin’s theory of natural selection not only deals a “blow” against the very notion of there being an intelligent designer, but also strikes another, “equally devastating blow against religion: It shows that the Problem of Evil is even worse than we thought” (p. 37). As Buchanan points out, “the whole survival of the fittest thing is astonishingly cruel,” leading him to ask the question: “If God is supremely good, why would he choose such a bloody mode of creation?” To the suggestion that our suffering is “compatible with God’s goodness because suffering enriches our lives, builds character, etc.,” Buchanan rightly points out that “many humans—especially children who die from violence or diseases and the millions of young men who die in war—experience suffering without much opportunity for gaining from it” (p. 38). But, Buchanan objects, “God’s making them suffer so that you and I can have a deeper appreciation of existence seems obscenely unfair” (p. 38). Moreover, “it appears there’s surplus suffering: God seems to have given us more than enough of it to make his point” (p. 38).

Even granting that human suffering might, perhaps, enrich our lives, Buchanan asks, how could it possibly have value for other, non-human creatures? As Buchanan puts it, “[t]he elk that’s devoured by wolves while still alive can’t console itself with the thought that elk life is enriched by character-building suffering. Thinking that the good that humans get from our suffering is so wonderful that we can simply turn a blind eye to the misery of all the other creatures seems a tad anthropocentric to me” (p. 39).

The “central point” of these reflections on the Problem of Evil, for Buchanan, is simply this: “IGM has the potential to achieve the good results of UGM, without the butcher’s bill” (p. 39). If we can, for example, introduce beneficial genetic changes more quickly and with fewer deleterious effects than the (unassisted) process of UGM would otherwise produce, this gives us good reason to consider pursuing IGM. Or, as Buchanan sums it up: “Evolution doesn’t count the cost of its improvements and it doesn’t care how the costs are distributed—it’s morally blind. If IGM can achieve the good that UGM achieves and do it not only more quickly, but without the moral costs, then that counts heavily in favor of it” (p. 40).

All of this is both de rigeur and “par for the course” when it comes to discussions of the Problem of Evil in the contemporary philosophical literature, and a thorough discussion of that problem is beyond the scope of this post. With respect to Buchanan’s attempted foray into the philosophy of religion in this context, suffice it to say that his comments here are less than persuasive. For one thing, we might ask the following question: might a perfectly good, all-powerful Creator have a good reason (or set of reasons) for permitting such suffering/evil to occur—i.e., some reason (or set of reasons) other than, or in addition to, “enriching” our lives? If this is possible, then it will hardly do to simply point out that there is such suffering/evil, intimate that we don’t understand what the good reason for it might happen to be, and then conclude from that fact that, therefore, there is no Creator.

More fundamentally, what if we, too, are not only epistemically but also “morally blind” as well? Given our own epistemic and moral limitations—especially our propensity toward moral evil—is there any good reason to think that we would do any better a job (through IGM) than UGM has done thus far?

One might argue, further, that talking about “suffering” (etc.) makes sense only in a theistic universe, i.e. one in which there is an intelligent designer of some sort. It certainly makes little, if any, sense in a strictly naturalistic universe, at least not in the sense in which Buchanan intends here—namely, that in which such “suffering” is morally significant.

Finally, Buchanan speaks of the ubiquity of “design flaws”—“suboptimal design,” he says, is “everywhere” (pp. 30-31). But speaking of “design flaws” in the products of evolution presupposes some sort of objective standard against which such deviations or “imperfections” are measured. Such a standard, in turn, may also imply the existence of a “species standard.” At the very least, it opens the door conceptually to one: if an objective standard is possible, then why couldn’t there be a full-fledged species design as well? And if a there is such a thing as a “species design” after all, then there may very well be good reason to be wary of the prospect of IGM.

In the end, if all you have just is a strictly naturalistic universe, then all you have just is life, death, development, coming into and going out of existence, etc., of various species. On such a scenario, “design flaws” are such only with reference to purely subjective criteria (individual goals, objectives, etc., of an organism), certainly not with respect to any objective standard of design. So it becomes difficult even to speak coherently of a design flaw.

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In the next post in this series, we will move on to an analysis of Chapter 3 of Better than Human. In that chapter, entitled “Changing Human Nature? Or, Unnatural Acts, and Not Just with Sheep Like Dolly,” Buchanan addresses the “changing human nature” and “changing biology” objections to the enhancement enterprise, respectively.

*****

Works Cited in this Post:

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

In praise of the Myriad Genetics decision—as far as it goes

The U.S. Supreme Court has recently been handing down a series of controversial decisions (as if you hadn’t noticed).  But a less contentious decision, nonetheless meaningful in bioethics, was the unanimous decision two weeks ago in Association for Molecular Pathology et.al. v. Myriad Genetics, Inc., et.al. 

Myriad Genetics has marketed a test for the cancer susceptibility genes BRCA1 and BRCA2, certain mutations of which greatly increase the risks of breast and ovarian cancer in women.  Their patent included the full sequence of these genes, as found in nature.  Enforcing that patent meant that any other company or lab—including a university lab or independent lab—was guilty of infringement if they attempted to test a woman for mutations of these genes in the course of her medical care, regardless of the method of testing used.  That in turn meant that in practice the Myriad Genetics test, along with its high price, had to be used.  The patents were challenged in court.

Myriad Genetics had discovered the naturally occurring gene sequences and claimed them in their patents.  The court held this part of the company’s patents invalid; one may not patent a discovery from nature, without creating a new substance or a new method of using that substance in an invention.  This opens the door for competing tests.  In “bumper sticker” terms, “life,” as it is encountered in nature, is not patentable.

What may be patented, among many other things in biotechnology, is something that Myriad Genetics and many other scientists and companies create from naturally occurring genes; namely, complementary DNA, or “cDNA.”  cDNA is the sequence of coding regions of a gene, with the non-coding regions spliced out, that is “complementary” to that gene’s messenger RNA (mRNA).  (In nature, a gene’s coding regions, called “exons,” are interrupted by noncoding regions called “introns.”  The introns are spiced out in the course of transcription, or reading, of the DNA to form mRNA.)  This part of the ruling limits the overall impact on the patent estates of biotechnology firms, which in turn means that the ruling is unlikely to impair the discovery and development of new treatments or diagnostic tests.  Similarly, the methods used in such discovery and development also may still be patented.

Something else that may still be patented is a genetically engineered organism—for example, a bacterium with a gene inserted so that it will produce a protein of interest that it would not naturally produce.  This represents a lot of activity; many such organisms are patented, including microbes and genetically altered higher animals like mice created for specific experimentation.

What of the future?  Could human tissues, made from adult stem cells for an alternative to organ transplant, be patented?  I would think that they could.  At a minimum, the procedures for growing such tissues could be patented.  If some future human embryo were enhanced with a gene to improve vision, what could be patented then?  My guess is that the process could be, but the actual person could not be.  This seems commonsense but of course one would need to see the actual cases, if and when they arise.

Commodification of life, including human life, remains an urgent concern, but it seems that, even if some altered organisms are patentable, it is unlikely that people, though they may be “made,” could be considered to be “invented.”  My guess is that this decision would help set a limit.  In any event, I think the court got this one right.

More on the “just price” of lifesaving drugs

It’s one thing when academic ethicists complain about drug prices.  It’s another when, as I discussed two weeks ago, physicians raise their voices.  And it’s yet another thing when a major industry scientific journal weighs in.

In the June 2013 issue, the editors of Nature Biotechnology, following on the discussion of the high cost of drugs to treat certain leukemias, broaden the discussion to cover expensive specialty drugs in general.  They are concerned.  A few snippets:

  • “[P]rice tags for drugs entering the US market continue to skyrocket.”
  • “To make matters worse, in the United States, most of this price inflation is being passed on directly to patients, leading to financial hardship.”
  • US drug costs are “increasing twice as fast as other healthcare services.”
  • While “in many cases, new drugs addressing unmet needs or offering major advances…do warrant high price premiums,” “companies also seek price premiums for drugs that have only marginal benefits…[and] industry’s dirty little secret is that the greatest contributors to increases in US spending are not new drugs, but year-on-year price increases for older drugs.”
  • “Thirty percent [a common co-pay rate] of a single $100,000 drug is a crippling burden.”

Read the whole thing.

Sure, the Nature journals originate in the UK, so we might expect a broadside from there aimed at the US.  But this particular journal is directed at biotech scientists and entrepeneurs trying to build successful companies.  So if its editors think industry’s behavior should change, maybe that says something.

Why the mess?  The editors charge that customers (public and private insurance entities) have an “asymmetry of information…that drug companies exploit,” and pharmacy benefit managers make money by selling more drugs at high prices negotiated behind closed doors with industry.  This strikes me as about as anti-free-market as one can get.  Defensible pricing should come as a result of a more open process of price discovery—negotiation and competition for business.

As a possible alternative, the editors suggest industry consider suggestions like one made by Harvard Business Review blogger Rafi Mohammed.   His idea:  differential pricing, with discounts, analogous to the way we buy, oh, just about everything we buy—cars, hotel rooms, airline flights, stuff at J.C. Penney (depending on who their CEO is today), and so on.  A patient’s out-of-pocket payment would be limited by the actual maximum amount a patient “should” pay.  That, in turn, would be determined by income, family size, etc—with an “independent third party agency” making the call.

Hmmm.  That sounds to me too much like eligibility for welfare, or unemployment insurance, or college financial aid.  A “FAFSA” for your medical bills, anyone?

I think I prefer an approach by which different levels of insurance coverage were offered, with different levels of co-pay, perhaps even different “formulary” drugs—and different premium structures.  But for it to work, there would have to be some level of societal/market agreement that the costs for truly effective and expensive drugs would be almost fully covered, and the out-of-pocket payments starkly limited to an absolute dollar amount that contributes to one’s overall out-of-pocket maximum for all coverage under a policy or program.  And, again, I don’t see how we can escape having a more explicit and open payer negotiation of prices and a firmer limit on paying for marginally effective new drugs or allowing previously-introduced drugs to increase in price year-on-year.

But the current state of affairs can’t go on like this, unchanged.

Physicians call for the “just price” of lifesaving drugs

A group of over 100 physicians who specialize in the treatment of chronic myelogenous leukemia (CML) have published a commentary in the journal Blood, decrying the high price of highly effective drugs, like Gleevec, for the treatment of CML.   The article was spearheaded by Dr. Hagop Kantarjian of M.D. Anderson Cancer Center, an oncologist who has become an articulate and authoritative voice in matters related to drug availability.  (He was prominent in discussions of the drug scarcity problems encountered in 2012.)  Their argument demands serious consideration by anyone—especially economic conservatives and pharmaceutical industry workers like me—concerned about the affordability of modern medicine.

Before 2001, the average survival of someone with CML was 5-6 years, and only about 20% lived for 10 years.  Long-term survival was possible for the subset of patients who were able to undergo a bone marrow transplant.  Otherwise, standard treatment was interferon (the protein drug that disappointed as the putative “cure for cancer” after its introduction in the 1980’s).  But CML has a specific molecular abnormality that can be targeted with a drug, and since 2001, several drugs have been approved.   With these drugs, 10-year survival is over 80%, and people with the disease generally live normal life spans—if they take these pills continuously.

And that’s where the problem arises.  In the US, the price of each of these drugs is about $100,000 or more every year, year in and year out.  Because of the way we pay for drugs supplied by a pharmacist, the patient—who needs these highly effective drugs to live—is on the hook for 20-30% of that.  That’s more than most people can afford, so they may skip doses or not take the drug altogether, greatly reducing the chance of benefit.  Actual survival results for CML in the U.S. are less than they might be, indicating that patients are not all getting the full benefit of treatment.  The CML doctors estimate that only about a quarter of all people with CML are getting these new drugs at all, and that only about 1 in 6 of those benefit from financial support programs, from foundations or the drug companies that make the drugs, to defray the costs.  In other countries, the drugs’ prices are about one-half of the U.S. prices (grossly approximating for the sake of brevity here), lower in countries with stronger government price controls or better competition in the marketplace.

Ah, yes, “competition.”  Regular readers of this blog know that I am an outspoken advocate of more “market-oriented” approaches to medical costs, on the grounds that top-down rigid controls will tend to create scarcity and limit options for individual patients and their physicians, and that insulating people from the costs of their medical care—i.e., socializing every dollar—would inflate those costs (the “skin in the game” argument).  But this last argument clearly does not apply in this case, and as for competition—well.  When it was introduced in 2001, the annual price of Gleevec was $30,000, compared to $22,000 for interferon—seemingly reasonable, given the huge leap in effectiveness.  But newer—and similar—drugs come for the more astronomical prices cited, and in that time, the price of Gleevec has tripled, rather than decrease.  So we have the exact opposite of the normal price competition that we are used to with just about everything else we buy.  Nobody can claim that this state of affairs is acceptable.

How on earth did we get here?  The etiology is multifactorial, as it were:  a process driven by insurers and industry; a “pass-through” mentality by which every new drug gets priced based on the prior similar drugs plus a mark-up; many details and issues related to patents, patent life, and the timing and requirements for generic competition; limits (at least in the U.S.) on price negotiation by payers (out of concern that the 800-pound gorilla, Medicare, will effectively dictate prices, an approach that generally fails for goods and services overall).   After discussing all of these, the CML doctors actually soften their concluding statements to an invitation to “dialogue” about all the factors involved.

This is a problem of justice.  I submit that it is not so much a matter of bioethics or medical ethics than of the intersection between those areas and business ethics.  I do not think that one can wedge the matter of drug pricing into Belmont principalism (except peripherally as a matter of justice), nor can one apply the ethical demands on physicians to pharmaceutical companies as entities, or to their employees.  But we can claim that the industry properly serves the proper ends of medicine, meaning that it takes its signals from what doctors need to help sick people.  And certainly it is basic business ethics to provide high quality products at fair prices.  And it is naturally incumbent on drug companies to adhere to ethical treatment of human research subjects (a non-controversial point).

But the CML doctors—quite understandably, I suppose—call for a (neo-medieval?) search for the “just price” of these drugs.  This seems misguided to me.  They claim that market prices really apply only to luxuries, but “when a commodity affects the lives or health of individuals, the just price should prevail because of moral considerations.”  But food, clothing, housing, automobiles, even computers affect our lives and/or our health, yet we don’t search for the just price for those.  The CML doctors’ claim has clear heuristic value but, if applied generally, runs into the issue of how big an umbrella to unfurl.  Also, I understand the search for the just price to have failed because value does not inhere in a product or service.  Rather, the value is in the judgment of the informed buyer.  Now, for a fair transaction to occur, the buyer must be on fairly equal footing with the seller.  That’s relatively easy when buying a shirt or a loaf of bread or even an iPhone, harder when buying a car or a house, and daunting or impossible when buying medicine.

In this case, however, the buyer is the payer—Medicare, or Aetna, or Anthem Blue Cross, or UnitedHealth, or some other insurer.  And so it seems to me that a somehow-improved improved approach to price negotiation between those entities and the sellers (industry) is in order.   That, in turn, means affecting how the buyers value drugs like the new CML drugs.  And that, further, means that this is an exercise in what costs we are willing to socialize (distribute across a large population), and what outcomes do we—most of whom do not have the disease in question—value on behalf of people who do have that disease?  As I have argued in this space, we should be willing to pay for somebody else’s life-saving drug when that drug is the real deal, as in this case.  While we’re at it, we should not make someone come up with 20-30% of that cost, but reduce those copays.  In the process, we might all accept that we have to pay a bit larger fraction of the costs of our own routine checkups and generic drugs and blood tests and maybe even our birth control pills.  If that means higher insurance premiums to cover truly effective drugs (not marginally effective ones), so be it.  If the whole process creates substantial downward pressure on new drug prices, will that stifle innovation?  I imagine it will reduce the number of new drug candidates in development.  I am not sure that it will reduce the number of safe and effective new drugs.  And I’m less sure that the overall public health or commonweal will be harmed.  Maybe we have to give it a try.

Finally, the CML doctors are right to advocate, aggressively, for their patients in this matter.  Doctors should not have the only “vote” in this discussion, but their collective professional opinion should carry great weight.  This is one of the proper “ends” of medicine, I think.