The state of PGD—an update from ASH

At the 53rd meeting of the American Society of Hematology (ASH), held from December 10-13 in San Diego, there was an “education spotlight” session entitled, “Preimplantation Genetics: The Science, The Medicine, The Bioethics.” The speakers were Joyce Harper, PhD, from the University College London Centre for Preimplantation Genetics and Diagnosis (PGD), and Mark Hughes, MD, PhD, from Genesis Genetics Institute in Detroit. I’m hardly a PGD expert, so I attended to hear perspectives from people who are practicing it. The session was long on science and medicine but too short on the discussion of ethics. This was a shame because the speakers clearly have ethical worries, even though they are clearly not congruent with the concerns of most TIU bioethicists. Still, I found the session thoughtful and informative.
There was far too much for a brief blog post, but here are some highlights, first on the medical/scientific side:
1) PGD can be made on a single cell (typically 1-5), taken at any of several stages of early embryonic development. Dr. Hughes showed how he takes a single cell at the blastocyst stage (5-6 days after fertilization). Results in 24 hours, with a stated diagnostic error rate of 0.7%, and an attendant 1% post-PGD risk of a genetic-recessive disease (compared with 25% by standard Mendelian genetics).
2) PGD is most commonly used by fertile couples to try to avoid a severe genetic disease after a first affected birth or known risk based on parental genetics.
3) Genetic analysis is moving toward genome-wide arrays that can read the entire genome quickly, and at ever lower cost (currently about $2500 per genome). Dr. Hughes: “The technology now has no limitations [diagnostically]…so the question is not ‘can we?’ but ‘should we?’” [diagnose].
4) Biopsied embryos generally—but not always—do well, so the success rate of the (necessary) IVF pregnancies is reduced. The number of implantations is also reduced—e.g., 12 eggs to get 10 fertilizations, 8 embryos biopsied, 7 successfully diagnosed, 5 abnormal and 2 normal, one of those two judged viable for implantation.
5) Dr. Hughes said there were 47,164 PGD babies in the US in 2010. I thought he said born in 2010 but that number sounds high for a single year. Still, it’s a lot.
6) The most prominent “savior sibling” examples are for a disease that is curable with bone marrow transplant (BMT), e.g., sickle cell anemia (SCA). The PGD baby’s umbilical cord blood (UCB) becomes the donor blood. An example is sickle cell anemia (SCA). Dr. Hughes told the story of the family of NBA player Carlos Boozer, whose first child was cured of SCA after receiving a UCB transplant after the birth of his baby brother. Dr. Hughes is working to take this approach to SCA to West Africa at low cost.
7) For a Mendelian-recessive disease, one needs an unaffected embryo that is also an HLA (immunologic) match, with the probabilities being ¾ x ¼=3/16. In other words, 16 embryos to get 3 genetically appropriate “saviors.”
As I said, the ethical discussion was compressed, and must also be here. Clearly one worries about all the other embryos created in this process—and at least one questioner at ASH raised this by mentioning the value of all people despite disease or disability. As someone who considers himself a strong pro-lifer, I do find PGD for the most severe genetic disorders a “hard case,” and I have to admit that I am reluctant to condemn the Boozers. The speakers were most concerned about how to limit the use of PGD, medically. They are clearly uncomfortable with drawing premature conclusions or taking action on the often-uninterpretable results of a genome-wide analysis. They also raised hard cases of using PGD for otherwise treatable disease (e.g., polycystic kidney, or to obtain UCB to transplant a sibling with leukemia), using PGD to get an Rh-negative baby when mom has sensitized to Rh in a prior pregnancy, or using PGD to eliminate a cancer-susceptibility gene like BRCA-1 from the family tree (Dr. Hughes would accept, but he had debated Francis Collins, who would not permit this). Bottom line: these two professionals do seem to agree that defending the “therapeutic boundary” is important. If I read that correctly, I find it at least a bit reassuring and perhaps a contact point for engagement.
Space does not permit more here. I’m happy to try to field questions or carry on discussion through comments.

Running from Pain

I’m a runner. I have been a serious runner for almost ten years. I am also blessed to have been relatively injury free. However, there was one occasion several years ago when I started having pain in my hip. The pain would extend to my back and down my leg. Wearing shoes with any kind of heel hurt. Even when I sat at a desk hurt, I would hurt.  I was clueless as to what was going on. I stopped running for a couple of weeks to see if it helped, but the pain just got worse. I (reluctantly) went to the doctor. After examining my range of motion and subsequent level of pain, he said I had all of the signs of arthritis, but I was too young (27 at the time) to have arthritis. If you’ve ever known a runner, then you understand the whirl of thoughts that go through his or her head. Usually these thoughts begin with “Oh no! I’ll never be able to run again!” They generally get more dramatic from there.

 

The doc took an X-ray; the only way to know for certain whether I had signs of arthritis. Waiting for the x-ray took an eternity, and I just sat there thinking about whether I really wanted to take up swimming or not (I was in the despair phase). The doctor came back and said my bones and joints look great. Everything looked great; that did not explain the horrible pain.

 

Another week went by. The beginning of the day was always better, but by the end of the day, I could barely stand because the pain was so bad. It was centralized on my hip and felt like it was the joint and the muscles were yelling at me in protest to doing anything. I tried icing. I tried heating. I hate taking pills for anything, but the only thing that brought some relief was Advil (generic: Ibuprofen). But that only masked the truth that I did not want to face. I was having chronic pain, and it might be arthritis.

 

My doctor suggested that I see a physical therapist. I had worked with a PT before, so he gave me the go to see her again. I recounted my tragic story of how my time as a runner had ended while in my twenties (I was in the acceptance phase). My PT took some notes and said, “Heather, stand up for me. Look in the mirror. Here is your left hip bone and here is your right hip bone.” They were completely off kilter. How did I not notice this before? She asked if I had had a fall. I told her that I tripped on a curb several weeks ago. It jostled me pretty badly, but I shook it off and was able to run back home without a problem. The pain came on gradually so I did not associate it with that incident. That fall had apparently knocked my hips out of alignment, and my muscles had been painfully compensating ever since.

 

What does this have to do with bioethics? Actually, it has to do with taking pain medicine. Some runners I know take an ibuprofen before every long run. Some athletes take them after. Some people take two every day just to feel better. The question is, have we become overly reliant on pills, particularly over-the-counter prescription pain medicines. A recent BBC News article discussed the problems with people overdoing the over-the-counter pain meds. Without going into too much analysis of our culture’s obsession with medicines, several points from the article are worth noting:

 

  1. Ibuprofen has more side effects than people realize. Personally, I know of a guy who had blood pressure issues due to taking ibuprofen. His blood pressure went down once he stopped taking them.
  2. Ibuprofen has become a kind of “medical crutch.” This is both to cut back on medical costs and as a band-aid for patients who do not want to deal with the actual causes (For example: Many issues with joint pain can be alleviated from diet, weight loss, and exercise).
  3. One pain management consultant interviewed in the article says that he believes ibuprofen (as well as aspirin) would likely not get an over-the-counter license today.
  4. Pain killers may mask what the body is trying to tell you.

 

After my physical therapist had found the culprit, I went through several weeks of intensive physical therapy, and was back to running pain free in no time. I could have easily done what many people I know do, take some Advil, go on the run anyway, and avoid the doctor. Pain medicines do have a place, but the pain should not be ignored. The pain is what told me that something was wrong, and had I not responded to it (albeit reluctantly), then I could have caused much worse, and much more permanent damage.

Of IOM, IT, EMRs, patient safety, and quality

 

If your doctor’s not looking you in the eye quite as much as he or she used to, it may be partially the fault of the Institute of Medicine (IOM).

In 1999, the IOM published a report entitled “To Err is Human: Building a Safer Health System,” which famously concluded that preventable medical errors cause up to 98,000 patient deaths annually. This was followed by the 2001 report, “Crossing the Quality Chasm: A New Health System for the 21st Century.” These reports touted, among other things, the power of health information technology (IT), including Electronic Medical Records (EMRs), to reduce medical errors, increase patient safety, and increase the quality of medical care. Subsequently, the federal government has stepped in, providing financial incentives for physicians who can demonstrate “meaningful use” of an EMR, and will soon be imposing financial penalties on those physicians who don’t climb onto the EMR bandwagon. Thus, the IOM is directly or indirectly responsible if your doctor isn’t looking you in the eye because she’s gazing into a computer screen instead.

Upon what evidence did the IOM base its assertion that EMR’s would improve safety and quality? Well … you know … it’s just kinda obvious, isn’t it? I mean, after all, it’s technology, and it’s gotta be better than paper, and it just makes sense that using more technology is better, right?

In fact, there was no data to suggest that health IT would improve either the quality or the safety of medical care. In the intervening years, as health IT implementation has exploded, there continues to be a paucity of data to suggest that health IT improves either the quality or the safety of medical care. There is good data that it introduces new errors and quality problems into health care.

Last month the IOM released a new report, calling for the formation of an independent federal body to investigate patient deaths and other adverse events caused by … drumroll, please … health information technology.

Dr. Richard I. Cook, an associate professor of anesthesia and critical care at the University of Chicago, said, “It’s not surprising that such adverse events are being found related to health IT, and it’s not surprising that those promoting these systems have neither looked for them nor anticipated them. To make large-scale investments in these systems and only now be looking at the impact on patient safety borders on recklessness.” Dr. Scot M. Silverstein, a consultant in medical informatics at the Drexel University College of Information Science and Technology in Pennsylvania, said that it is “unethical” to expand health IT so dramatically without understanding the precise nature of the risks it poses to patients.

“Reckless” … “unethical” …

Meanwhile, my doctor’s still not looking me in the eye because he’s trying to find something in the computer. Sheesh! This is quality improvement?? Have we simply created a new “Quality chasm”?

 

(The quotes above are from this story which was published in the AMA news.)

Abortion: Unbridled Democracy in Action

 

When reading a piece by Joseph Ellis on the founding of the US, American Creation, I came upon an insightful saying. I am not sure if this is a common saying and/or if I have heard it before and it just didn’t click. Whatever the case may be, it caught my attention.

The context in which Ellis wrote the phrase, “Unbridled democracy in action,” was concerning the gradual removal of Native American tribes by the expanding United States. However, is it not the case that we see unbridled democracy in action, perhaps even more than ever, in America today?

Here I am not necessarily referring to the destruction of a people as an exercise of liberty, although addressing that may be apropos. I am talking about the extension of liberty at the expense of morality and justice. While we all stand firmly on the preservation of liberty, is this not the very principle people use to justify all kinds of deeds?

 

One such deed is abortion under the guise of “procreative liberty”. This is portrayed best, perhaps, in the mistaken ruling of Roe vs. Wade delivered by Mr. Justice Blackmun:

 

“The principle thrust of appellant’s attack on the Texas statutes is that they improperly invade a right, said to be possessed by the pregnant woman [Doe], to choose to terminate her pregnancy. Appellant would discover this right in the concept of personal “liberty” embodied in the Fourteenth Amendment’s Due Process Clause; or in personal, marital, familial, and sexual privacy said to be protected by the Bill of Rights…” (Section V)

 

The ruling did two dangerous things: 1.) Extended the rights of woman based upon an abstraction of the language of liberty in the constitution (I understand Blackmun cited case precedence also), and 2.) Usurped state’s rights.

The first is true because of a soft/fluid interpretation of the constitution. And despite the claims of Mr. Justice later in his delivery of the opinion of the court,  the second is true because the ruling made abortion legal nationally, which demolished standing state legislation across our nation without legislative due process.

Not to mention that this ruling negated the foundational facet of a three-faceted ideal: the right to life, the right to liberty and the right to the pursuit of happiness. What about life?

Bioethics and Christmas part 2

Even those without much Christian background know that Christmas is about the birth of the baby Jesus. Christmas carols, nativity scenes and creches, and even the pictures on Christmas cards depict the miraculous birth. What is interesting for bioethics is that the story starts before the birth.

Luke tells us in the first chapter of his gospel that the story began with an angel telling Mary that she was going to conceive a child through the intervention of the Holy Spirit without the usual sexual process. God didn’t take much time to do that because by the time she could get ready and hurry off to her relative Elizabeth’s house she was already pregnant. When she got there Elizabeth was in the sixth month of her pregnancy with her own angel-announced child. When Mary entered Elizabeth’s house, John (Elizabeth’s baby who later identified Jesus as the lamb of God) leapt in recognition of the presence of Jesus in Mary’s womb.

This detail of the story suggests that the incarnation impacts how we think about unborn human beings. Since Jesus became a human being it means that human beings have a special status as members of the class of beings that God chose to become. His beginning human life as an embryo and fetus that went through the usual nine months of prenatal life implies that the special status of human beings applies to human beings before they are born. The recognition between John and Jesus suggests the continuity of identity of individual human beings from early prenatal life to after birth.

Remembering that Jesus’ incarnation began nine months before his birth reminds us of the moral value of unborn lives. We should be just as amazed by that as those the shepherds told were amazed about his birth.

Infinite demand and the drawing of lines

 

Many of the problems with health-care financing in our country come about as a result of difficulty with line-drawing. I’m not talking about geometry, but about making hard decisions.

This difficulty with line-drawing is not new. In 1971, while Congress was debating national health insurance (!), a man named Shep Glazer testified in dramatic fashion before the House Ways and Means Committee about funding for renal dialysis — while hooked up to a dialysis machine. “Gentlemen,” he said, “what should I do? End it all and die? . . . If your kidneys failed tomorrow, wouldn’t you want the opportunity to live? Wouldn’t you want to see your children grow up?” After thirty minutes of debate in the Senate and ten minutes in a House-Senate conference committee, Congress voted to extend Medicare coverage to any and all who need dialysis. The uncharacteristically short amount of time spent considering this action, one that should have raised some very hard questions about things like the just distribution of limited resources, suggests that the hard questions were ignored in favor of doing something that feels on the surface very good — paying for everybody’s dialysis — but that has far-reaching, unexamined consequences.

An excellent article in the Chicago Tribune last week described a recent iteration of the old problem. Through medical advances, increasing numbers of our oldest citizens are being made healthier by procedures that were once reserved only for younger people: it is not unusual for people in their 90s to have hip replacements or a 102-year-old to have a heart valve replacement. Now, these are good things! These people are living more fruitful lives through medical procedures. But they are living under a system, Medicare, that does not consider price, but only benefit to the patient, in making decisions about what medical procedures it will cover. And as the proportion of the population receiving Medicare expands, and as expensive medical techniques proliferate, the demand for such procedures will be virtually infinite. Unfortunately ,the resources to pay for them will be all-too finite.

At some point we have to go beyond emotional appeals, beyond doing the thing that feels the best but which bankrupts the country (covering everything for everybody at any cost). At some point we have to draw lines, to make hard decisions about who will get what — and who won’t.

What is the most ethical, most just way to make this decision? The Tribune article mentions one solution put forth by Daniel Callahan and Sherwin Nuland: set a cutoff age (they suggest 80) beyond which people will not be covered for anything beyond “good basic health care.”

Callahan said, “If you want to save all lives, you’re in trouble. And if you want to save all lives at any cost, you’re really in trouble. . . We need to stop thinking of medicine as an all-out war against death, because death always wins.”

Callahan’s perspective in that last statement is a good corrective to distorted expectations of medicine. I don’t agree with how and where he draws the line on providing medical care; but if it gets the discussion going, it’s at least a place from which to start.

Bioethics and Christmas

I just got back from the Taylor Christmas chapel and as my thoughts have been focused on the amazing incarnation of Jesus, I thought I would share some thoughts over the next few weeks on how Jesus’ incarnation impacts bioethics.

One of the most fundamental principles of bioethics is the inherent value and dignity of all human life. Our ideas of equality for human beings and equal human rights, moral status, and justice all depend on our understanding of the value that each of us has as a human being. When Christians think about the value of human beings we usually think about creation and our biblical understanding of human beings from the account of creation in Genesis 1 and the moral laws given to Noah in Genesis 9. Both of these passages refer to human beings being made in the image of God. We find an understanding of our inherent moral worth in how we were made.

Jesus’ incarnation adds richness to our understanding of who we are as human beings. God made us in his image not just so that we could be enough like him that he could communicate with us and have a relationship with us, but so that Jesus could become one of us. He made us able to choose between right and wrong, knowing we would choose the wrong. He planned all along to have Jesus, the Son, leave his glory as eternal God to become one of us, so that he could be the ransom for our sin. Being made in God’s image helps us see why every human being has moral value. Being one of the class of beings that God chose to become, and for whom he chose to die helps us see that value even more.

Glory to God in the highest.

Some Things Are Wrong

I was going to write a post reporting on a recent research paper; however, I came across an article that I thought was worth linking and discussing on a bioethics blog. Denyse O’Leary, a journalist who writes for several blogs and whose work I have followed, posted this article recently at thebestschools.org. See here for “Is it still wrong if another culture says it is right? A teacher’s surprising discovery.”

In sum, students in a philosophy class were hesitant to say that a cultural practice was wrong, in this case a woman was mutilated and left for dead for fleeing an abusive man that she was forced to marry, because they did not want to criticize another culture. The post recounts the teacher’s surprise that the students, who obviously had a strong reaction to the woman’s story, were not willing to say that this cultural practice is wrong. The teacher was trying to use this as an obvious example before engaging in more difficult examples.

Denyse O’Leary’s assessment of why the students respond this way is worth reading as well. She considers virtue and vice in our culture. The one action that is still considered a vice is judging others, particularly other cultures. The hesitancy to judge other cultures is understandable. History has shown the failings of cultural imperialism, and often those of us who have grown up in a global and diverse world want to avoid assuming my culture is the best, let alone in a position to judge other cultures. This feels arrogant, and undoubtedly some people have taken their notions of superiority too far. However, does that mean that everyone is right and no one is wrong? Does this mean that there aren’t some things that are just straight up bad to do no matter the time and place?

I recently read Harold Netland’s book Encountering Religious Pluralism. Netland focuses his discussion on missions, in particular, but there is a relationship between religious pluralism and cultural relativism. In his assessment of missions, he points out that “the modern missionary movement has had an ambivalent relationship with eighteenth- and nineteenth-century Western imperialism, leaving a legacy that, among other things, has helped make the agenda of religious pluralism attractive today…For many in the West are drawn to pluralism in part out of a deep sense of postcolonial guilt…” (Netland, 30). And perhaps this post-colonial guilt drives the cultural relativism that we see today.

Other cultures do challenge our notions of right and wrong, and, I believe, help protect against legalism and superiority. For example, growing up in the U.S., I thought it was morally wrong to drive on the left side of the road. The only people who drove on the “wrong” side of the road were crazy or drunk (or both). As I got older and learned about other countries, it turns out that there is nothing inherently righteous about the right side of the road. Road rules are culturally relative.

However, not everything that is legal or acceptable in other cultures is morally relative or morally neutral. This is not to “rank” or make claims about the superiority or the inferiority of other cultures, but it is okay to recognize that there are some cultures that engage in unethical activities. Mutilating a woman who flees her abusive husband is morally wrong, no matter its legality or acceptability. The U.S. has a history of racial slavery that may have been legal at the time, but was still wrong and a violation of human dignity. Today, adultery is legal in many countries, but that does not mean that breaking a marriage vow is right. And while many people would consider adultery debatable, almost every culture recognizes that stealing another man’s property (in the broad sense, not just land) is wrong, yet the laws on this vary from country to country.

As bioethicists we need to be open and understanding of other cultures and not impose our particular preferences on others as if our preferences are morally superior. However, we also need to recognize no culture is perfect and therefore every culture has norms that are at least questionable if not outright wrong, which is not an issue of preferences but of ethics. While it may be difficult to discuss a culture’s ethic when they may have different moral foundations than we do, we can find common ground in certain things. The inherent worth and dignity of human beings is a good place to start.

A Dispatch from A Front

I just attended the Advancing Ethical Research Conference of the group, Public Responsibility in Medicine & Research (“PRIM+R,” or “PRIMER,” because they make the “and” symbol look like a rounded “E”). Saturday’s plenary address was by Jonathan Haidt, Professor of Evolutionary Psychology at the University of Virginia. His topic: “The Intuitive Foundations of Morality (Or, Why some Research is Offensive to Some People).” Key points:
1) His introducer noted Dr. Haidt’s forthcoming book, The Righteous Mind, with the comment that Dr. Haidt research had discovered that all people are deeply flawed, morally. (I made a mental note that he should be congratulated for “discovering” original sin.)
2) Dr. Haidt described himself as an intuitionist but definitely not a cognitivist, having been thoroughly convinced by David Hume that “reason is the slave of the passions.” He described reason as the “rider” on the back of an “elephant” (emotions). (Essay assignment: compare and contrast with Plato’s chariot allegory in the Phaedrus.)
3) He identified 6 basic moral values: care (vs harm), fairness (vs cheating), liberty (vs oppression), loyalty (vs betrayal), authority (vs subversion), and sanctity (vs degradation). These, to him, are analogous to flavors, and the ability to regard them, in the moral sense, is analogous to different taste regions on the tongue. He spent considerable effort applying this to contemporary American politics. Liberals, he argues, value care far above all else, with fairness and liberty a strong but distinct second and third. Conservatives esteem care highly, but less than fairness and liberty. However the other three—loyalty, authority, and sanctity—are also highly valued by conservatives, but disregarded by self-described liberals. This leaves the liberal “moral sense” akin to being able to taste only sugar.
4) Esteem for sanctity, more than self-described conservatism, correlates in his research with some people’s “repugnance” at things that [allow me to interject] ought to be repugnant (though I don’t think he’d go that far).
5) Although the received wisdom is that contemporary bioethics is “autonomy on steroids” (my phrase, not his), as it were, IRB’s actually Invert the priority of the Belmont principles by making beneficience paramount. Top of the list of the IRB’s charge is to ensure that research risks to subjects are minimized and reasonable compared to the likely benefits. Informed consent is critical but comes after that. (Justice, in the form of equitable selection of subjects, may be third but is charging hard on the outside.) Note that there are no Belmont counterparts to loyalty, authority, or sanctity.
6) By a show of hands, about 40% of his audience was “liberal” and about a third of that number “conservative”—“the most conservative audience” he has spoken to.
It seems to me that Dr. Haidt really wants to be a moral realist and not an emotivist. But he appears not to allow that pre-rational commitments might be anything other than emotional. I am reminded of J. Budziszewski’s rejoinder that “naturalist” natural law fails; I prefer his appeal to “deep conscience” as the source of our moral intuitions (if I read him correctly). Also, Haidt’s “scientific” approach seems artificial to me (think: Postman’s Technopoly) and his categories thin alongside the biblical language of sin, righteousness, etc. (I couldn’t help also thinking of Paul Ricoeur’s The Symbolism of Evil.) But I want to read The Righteous Mind and I hope Dr. Haidt will have the chance to engage some conservative audiences.

Knowing too little about too much

 

With the ability to map the human genome, we find ourselves in the bewildering position of knowing too much and knowing too little at the same time.

Consider this scenario: The year is 2015. You, being the modern that you are, want to know your future, so that you can have some degree of control over it. You’re pretty sure astrology isn’t very helpful; but you’ve been keeping up with Time and Newsweek, and you’re thinking from what you’ve read there that genetic testing offers the scientific equivalent of what astrology promises. So you go down to the local Genetics-R-Us and for a mere $99 have your entire genome analyzed in 15 minutes. You then sit down with one of their genetic consultants, who reveals that you have a 64% likelihood of developing diabetes and a 43% chance of developing colon cancer. You go on a vegan diet, exercise three hours a day, and start a regular regimen of bowel cleansing and weekly colonoscopies. You have your genome analysis results sent to your primary care provider (PCP) to be part of your medical record.

Fast forward to 2025, when you are diagnosed with a rare cancer of the nose. After a little research, you discover that this particular type of cancer can be predicted by genetic testing. Genetics-R-Us went out of business, so you go to your PCP and demand to know why she didn’t warn you about the possibility of this cancer. She steps out to do a little research and comes back into the room:

“It turns out that the gene that predisposes you to this kind of cancer wasn’t discovered until 2019, and you had this test done in 2015.”

“But when that information became available, why didn’t you go back and recheck my genome?” you reply.

“That’s the responsibility of the company that tested you,” she says, as she gets her defense lawyer on the phone.

“But Genetics-R-Us went bankrupt! You’re the only one who has the data!”

“We have thousands of these genome maps in our records, each consisting of six billion base-pairs. They are encoded in various formats, none of which are compatible with each other, and some of which are so outdated we can’t access them anymore. Plus, a 200-page update of the latest new gene dicoveries is published every month. We simply don’t have the resources to go back through everybody’s individual genome and check for all of these genetic abnormalities that are constantly being discovered.”

***

With the capability to map an individual’s genome, we can gather lots of data, but we do not yet have the knowledge of how to apply that data (much less the wisdom with which to use it!). We know too little about all that we know. As genome testing becomes more affordable and widely available, some of the ethical questions that arise are, Is there an ethical obligation to go back an re-analyze data in light of new findings? If so, whose is the responsibility?