Managing Patients

Many people remember C.S. Lewis not only as a gifted thinker but also as someone who was very funny.  Funny in a typically British, understated, often-profound way.  When reading That Hideous Strength, the last book of his Space Trilogy, I laughed again and again at his many references to the National Institute of Co-ordinated Experiments.  Yes, you got that right: the N.I.C.E.  This vast array of committees and investigators would finally bring a “really scientific era” to managing society, and eventually all the ills of the country would be deciphered and cured.   And of course building this grand enterprise meant bulldozing a large part of a quiet university town—all for the sake of noble, or at least “nice,” goals.  True, one might have to keep the citizenry in the dark on what actually was going on inside the N.I.C.E., but of course this would be for their benefit.  (“You musn’t experiment on children; but offer the dear little kiddies free education in an experimental school attached to the N.I.C.E. and it’s all correct!”)  The book is great commentary on misguided human endeavors and is prescient on many of the bioethics matters of today.  But what is most entertaining is that the N.I.C.E. is indeed alive and well in the United Kingdom: the National Institute for Health Clinical Excellence, a.k.a. NICE.  More on this in a moment.

Christ and the Canaanite Woman by Germain-Jean Drouais (1784)

During the past five weeks of my Psychiatry Clerkship, I’ve seen that we are often in a position to simply do the best for patients with the little we have.  Many of our patients suffer from life-long substance abuse, others are being monitored because of signs they might harm someone, and others are there at the request of the courts.  It’s easy to fall into a “managing patients” mode of just keeping things from getting out of hand but never really helping the patient recover from his illness.  (Especially when the patio re-modeling keeps some patients from being able to go outside for two weeks.)

One of the populations that figure prominently into “patient management” is that group diagnosed with antisocial personality disorder.  NICE has dual concerns of managing resources as well as managing antisocial patients who may cause harm to society in the form of criminal activity, for instance.  NICE working groups have to come up with guidelines for handling these patients.  For instance:

Pharmacological interventions should not be routinely used for the treatment of antisocial personality disorder or associated behaviours of aggression, anger, and impulsivity.  Pharmacological interventions for comorbid mental disorders, in particular depression and anxiety, should be in line with recommendations in the relevant NICE clinical guideline.

Psychological interventions such as Cognitive Behavioral Therapy, on the other hand, were found to be wise uses of funds in working with these patients.

It is easy to click through a patient roster quickly in order to carry out management guidelines and lose a sense of the human being who is at dis-ease because of an illness.  This is why I think Christian hospitals and places of rest for the mentally ill offer something that our modern health care systems do not: their reason for being is first the healing ministry of Jesus, seeing that the ill become whole.

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Reporting from Minneapolis

 

MINNEAPOLIS (JG) – The annual conference of the American Society for Bioethics and Humanities (ASBH) is taking place here in Minneapolis. This is the big conference for the major bioethics organization in the country, and this is my first time attending.

The conference began yesterday with concurrent paper sessions, one of which was entitled “Dignity and Enhancement.” Having some acquaintance with both of these topics through my association with CBHD, I looked forward to hearing the speakers.

Four people presented papers. One discussed competing concepts of human dignity. She was willing to accept the existence of something called dignity, but couldn’t see how the concept gave any practical moral direction; the idea that “I should work to preserve another’s dignity because I want mine to be preserved” was not convincing for her. Another presenter, speaking on neuroenhancement, argued that tools are extensions of our minds; so if we’re OK with enhancing and and improving tools like, say, smartphones, which are the external machinery of our minds, then we should have no problem with taking medication like Ritalin to enhance and improve our brains, which are the internal machinery of our minds. (He kept putting up a slide that equated an iPhone with a Ritalin tablet.) In fact, it might be an affront to human dignity to prevent or limit opportunities for neuroenhancement.  Yet another presenter, addressing the question of whether or not human dignity is an essential principle of bioethics, was willing to allow that the concept of human dignity isn’t entirely useless, which I was glad to hear; but then she asserted that it is actually a way of “sneaking religious assumptions into a secular-sounding word,” and she left very little doubt regarding how she felt about sneaky religionists infiltrating an obviously secular field like bioethics. She agreed with a member of the audience who stated that the problem with dignity isn’t that it’s a sneaky religious term but that it is a manifestation of “human exceptionalism” (the belief that humans have a special status compared to animals).

I learned a lot in this 90-minute introduction to the cutting edge of contemporary bioethics. I learned how tenuous  in some quarters of the academy are the concepts that undergird respect for and protection of humans. I learned how important it is to sit back and listen and understand what those who hold opposing views actually believe (one of the presenters seemed very adept at misrepresenting views opposed to hers; we must be careful not to do the same thing). I was impressed again with the critical need for Christians and the Church to engage the culture at all levels on these topics.

As we got up to leave, a friend from CBHD who has attended these conferences before — and had previously hinted at what I could expect — leaned over and said, with a chuckle and more than a hint of irony, “Welcome to ASBH!”

An eye-opening welcome, indeed.

The Silent Partner

As I mentioned a couple of weeks ago, my wife is pregnant! This means, among other things, lots of doctor visits, name ideas, inappropriate questions from strangers and lamaze jokes (who could possibly take that seriously).

In between reprimanding me for my antics and misbehavior at the Doc’s office, my wife has been asking me about the necessity of the MANY medical options before us: Should we have that test? Are we really going to do that? Do we really have to do that?! In most cases the answer is “no”. Most of the test’s “discoveries” offer no moral solutions (more on this next week).

But it is good that she asks me these questions because most of the interactions between my wife and the doctor are completely predicated on the idea that I am not there.  I am a fly on the wall. A silent partner. So like a child not receiving attention, I find myself inserting random comments and thoughts during these appointments usually to no avail.

This whole thing concerns me. Are other expecting fathers being treated like this?

Is this why so many men have taken up a distant role in parenthood? Perhaps I have the cause and effect backwards: maybe because men traditionally have played a more distant role we have now been relegated to a quiet place in the corner. It seems no matter which of these is true, one thing has become clear to me: at times, to the detriment of a partnership in parenting, women’s rights take precedence in medical decision making during pregnancy.

 

 

Privacy and the risks of IVF

A recent article in Toronto’s National Post tells of the experience of Dr. Rosanna Weksberg, a University of Toronto geneticist, when she presented a talk on the need to study risks associated with IVF (in vitro fertilization) to the Canadian Fertility and Andrology Society. Her talk related her experience in seeing an increased number of children with rare genetic disorders among children conceived by IVF. Some of those disorders are seen as much as 10 times more often in children born by IVF.

She expressed her concern that follow-up studies of children born by IVF are needed. The reception from the meeting of fertility specialists was polite, but no interest in her proposal for study was expressed. She said she has been trying to find fertility clinics willing to partner in studies of children born with the help of reproductive technology, but has not found any willing to work with her. A spokesman for the fertility society said they were interested, but that clinics could not afford to fund research.

In the United States assisted reproduction is a 3 billion dollar a year industry, but like in Canada there is no accurate information on the risk of genetic disorders, birth defects, or other increased health risks of the children produced by these procedures. Our culture has set apart everything having to do with sexuality and reproduction in a domain protected by privacy. That protection is so complete that it causes assisted reproductive technology to be entirely unregulated and makes any attempt to study the outcomes of the children produced exceedingly difficult. We need to recognize that, even though privacy in reproductive decisions is important, people cannot make responsible decisions without good information. Those contemplating the use of assisted reproductive technology need to know what the risks are for the children they bring into the world. They owe it to their children.

Mary had a little “Mary?”

Last week the journal Nature reported that scientists in New York have created human embryo clones for the purpose of developing patient-specific stem cells. The process involves reprogramming a human egg via somatic cell nuclear transfer so that the egg becomes an early-stage human embryo. The hope is that, in the future, the patient’s own DNA will be used to produce the clone and, thus, he or she will have access to matching stem cells. Successful clones using animal eggs go back to the 1996 conception of Dolly, the cloned sheep. However, according to Nature, “When it came to humans, researchers didn’t have unfettered access to the key resource, eggs — at least not in the numbers that they needed to tweak the finicky procedure for human biology.” Of course, this “finicky procedure” entails the controversial procurement of human eggs from donors, the inevitable trial and error destruction of the newly created human embryos in order to produce a successful clone, and the eventual killing of the cloned embryo at the blastocyst stage in order to extract the desired stem cells.

For example, in the latest research, scientists obtained 270 eggs from 16 donors, in and of itself a risky procedure for the donors. The unique feature of this latest research is that researchers discovered that previous attempts at cloning failed because of the difficulty of removing DNA from the human egg. This time, they decided to leave the original DNA in the egg and simply added the donor’s DNA. This novel method resulted in the creation of an embryo with an additional set of chromosomes. The newly created embryo grew to the blastocyst stage which is, of course, the phase at which stem cells can be obtained. The problem for future research is that, with an additional set of chromosomes, the stem cells are no longer a match for the patient. Instead, we are left with an abnormal human embryo with too many chromosomes. Even so, scientists press on with their research because they doubt the success of iPSCs; cloning offers a “more natural” method of obtaining stem cells.

It seems almost comical to think that adding someone else’s DNA to an egg that already contains its own DNA is somehow a “more natural” process. Nonetheless, from my perspective, it seems that researchers are very quick to highlight the apparent problems with iPSCs, a technology that is still in its infancy, and yet downplay the obvious technical and ethical problems with hESCs.

Reflections from the Front: We All Answer to Someone

Reflections from the Front: We All Answer to Someone

“Surgeons routinely fail to disclose financial ties” is the title of a  Journal Sentinel article by John Fauber, http://www.jsonline.com/features/health/102811174.html. Fauber outlines how over the last several years a number of leading orthopedic surgeons received millions of dollars in “consultation fees”, to use and promote products from specific manufacturers. Hospitals and patients were unaware of the conflicts of interest. These types of violations are illegal under current anti-kickback laws, but nonetheless in 2007, “41 surgeons and researchers got $114 million from the five firms (limited study), an average of $2.8 million each.”

In www.neurotodayonline.com August 4, 2011, Volume 11, Issue 15, Kurt Samson details an unethical practice referred to as “seeding”. In seeding, the drug company secures high profile researchers to participate in studies which they believe legitimate.  With the new drug on the guru’s front burner, the hope is that in the course of their professional presentations they mention their new trials. The aura of “They’re using it in trials at the Cleveland Clinic” provides legitimacy by association. It works for high prescribers as well. If busy clinicians become involved in the trial, they may also begin prescribing the medication for their other patients as well. The fulcrum of the duplicity as discovered in a recent court case against Parke-Davis, was to pretend  the results of the trial were important for proof of safety or efficacy, when  these facts had already been proven. This was purely a marketing ploy.

During the early days of the stem cell controversy in America, in discussing embryonic versus adult stem cell research funding, outspoken scientists claimed that the science of the research was so complex that no non-scientist’s opinion was worth hearing on the ethical aspects of the question. The obvious conflicts of interest, who is receiving funding from whom, to what ends, were ignored. Over time the overblown claims of the embryonic researchers have been proven to be just that. I witnessed a researcher claim in a symposium in our medical school that the future of stem cell research depended primarily on embryonic experiments. Later, in private, when I questioned him, his response was, “Anyone knows that thus far the adult stem cell research has been far more productive, but I don’t want anyone telling me what I can do my research on.”

My points?  1) Follow the money, 2) Accountability, with checks and balances is important in research and education (government, religion, etc.), and 3) We are all fallen human beings. Contrary to what President Clinton said while in the White House, as humans we are not all “basically good people.” Made in the image of God, we are nonetheless fallen; power corrupts, and researchers need to be answerable not only to academia, but to society at large. These issues are too important to leave to scientists, and the church is far too important a voice to abstain from accountability discussions. We must remain attentive and involved in the forum.

 

TIU Blog 2011 Number 3

Human cloning “breakthrough?”

 

Last week, Joe Gibes commented on the BBC’s report on the scientific “breakthrough” of  Dieter Egli and his colleagues at the New York Stem Cell Laboratory. As the BBC and other news agencies presented it, Egli et al derived human embryonic stem cells through a “cloning” technique, but as Joe correctly noted, no clones were produced. In transferring the nucleus of an adult skin cell to a nucleated human egg and retaining both sets of DNA during subsequent embryonic development, the researchers had actually  created not clones but  genomic hybrids with, I would add, a generally lethal defect (triploidy).

I see nothing sinister behind the imprecise language, and I don’t think Joe does either. It is, in fact, understandable as the method employed was essentially a modification of the technique (“somatic cell nuclear transfer”) that Ian Wilmut and his colleagues at the Roslin Institute used 15 years ago to create “Dolly” the sheep, the world’s first clone of an adult mammal. The chief difference is that Wilmut et al transferred the donor nucleus to an enucleated egg.

Cloning adult mammals is, to put it gently, no piece of cake. In their ground-breaking publication that introduced Dolly to the world, Wilmut et al reported making 434 attempts to fuse a nucleated donor cell  to an enucleated egg. That effort yielded 277 (63.8%)  zygotes (“fused couplets”) which they then transferred to ligated sheep oviducts for culture. Of those 277,  247 (89.2%) were recovered and of those, only 29 (11.7%) developed to a transferable stage (morula/balstocyst). As a fraction of the original 434 eggs, that represents 6.7%. Now, 14 years after the initial report of Wilmut et al, the process of producing clones from adult mammalian cells remains highly inefficient.

The “Holy Grail” of cloning, as Joe and others have put it, is not a cute little lamb, but a human embryo. Most researchers in the field recoil at the idea of cloning to reproduce full-sized copies of ourselves, but they salivate at the prospect of creating disposable, embryonic miniatures whose genomic identity would purportedly constitute for their “parents” the key to great medical benefit. Human biology, however, has proven quite resistant  to such designs, and that, I would submit, is the “story behind the story” of Egli et al. The whole reason these researchers moved to the hybrid model was because of their inability, and that of many others before them, to produce an embryonic human clone using techniques that, albeit with great inefficiency, have proven successful in animals.[1] What the BBC and others tout as a “breakthrough” is, in fact, little more than an affirmation of the status quo in human cloning research.

Whether human biology will continue to frustrate the dogged efforts of Egli and others to produce a human clone, only time will tell. But at this stage, reality certainly mirrors fiction as the quest for the “Grail” remains exactly that – a quest. Sadly, this quest to clone ourselves exacts a great toll as it drains finite resources and, more concernedly, does great violence to human dignity with its reduction of human life to an object of mere utility.  That we would dump the quest and focus our health resources elsewhere seems a right and sensible thing to do, but I’m not banking on that happening soon as many a policy-maker and researcher are “all-in”  in the gamble on so-called “therapeutic” cloning. That researchers have already discovered a method for re-programming adult human cells to a pluripotent state that requires neither a human egg donor nor an embryonic intermediate reveals the ongoing quest to produce a human clone to be less about advancing good science and medical therapy and more about satisfying a prior agenda.


[1] Sheep (1997), Mouse (1998), Gaur (2000), Pig (2000), Mouflon Sheep (2001), Cat (2002), Cow (2002), Goat (2002), Rabbit (2002), Deer (2003), Horse (2003), Mule (2003), Rat (2003), Wildcat (2003), Dog (2005), Banteng (2005), Ferret (2006), Swamp Buffalo (2006), Gray Wolf (2007).  See the US Food and Drug Administration online publication “Technology Overview: Somatic Cell Nuclear Transfer and Other Assisted Reproductive Technologies” at http://www.fda.gov/animalveterinary/safetyhealth/animalcloning/ucm124765.htm

Embryos and antioxidants

 

My heart almost stopped when I read the headline on Wednesday’s BBC article, “Human ‘cloning’ makes embryonic stem cells.” At first glance, I thought that the Holy Grail of embryonic stem cell research had been found: a way to generate personalized stem cells by cloning a person, then destroying (killing) the clone at the early embryonic stage in order to retrieve the stem cells that are oh, so tantalizing for the cures that they might hold: fixing everything from diabetes to heart disease to Alzheimer’s to aging itself.

However, a closer read of the story shows that we are no nearer the Grail than before. Cloning involves removing the DNA from a donated egg cell and replacing it with the DNA from the somatic cell of another person, making that egg cell into a genetic duplicate or clone of the person; the clone can then grow and develop stem cells. But what the scientists actually did here was to create a genetic hybrid: an embryo that contains both the DNA of the woman who donated the egg cell, and the  DNA of the person to be “cloned.” This means that each cell of the resulting embryo has three copies of each chromosome, rather than the two that each of our cells normally carry. Leaving aside for the moment the ethical questions surrounding deliberately creating something/someone so abnormal (there’s a whole book to be written there) and deliberately killing embryonic human beings, the insurmountable problems of using stem cells that are so genetically abnormal make them useless for any “cures.”

Meanwhile, a story in yesterday’s Chicago Tribune reports on antioxidants, “one of the hottest buzzwords in the health and wellness industry. Manufacturers have emblazoned it on everything from water and cereal to alcoholic drinks.” Theoretically, antioxidants, by cleaning up free radicals, can help slow the processes associated with damage caused by free radicals such as heart disease, cancer, stroke, and even aging.

The problem, of course, is that there is little to no evidence that antioxidants actually do anything of the sort, and there is good evidence that in some circumstances they may be harmful. Nevertheless, hundreds of products with antioxidant claims are developed yearly.

What’s the connection between the two stories? Two therapies that don’t work , but for which the public is willing to spend gazillions of dollars. Two therapies that promise, as an antidote to degenerative diseases, regeneration — restoration — to some, the hope of eternal youth, even eternal life.

From the numbers of people who buy into these forms of snake oil, it appears that the longings for regeneration and eternal life run deep in our race. As Christians who have experienced regeneration, and who have met the only true source of Eternal Life, we just might be able to offer some true hope in place of the hucksters’ hope to which so many cling.

Ethical Blind Spots

Recently I have been impressed with how much there is for those of us who are involved in bioethics to learn from those who study other areas of ethics. Business ethics in particular has a lot to offer. A recent article in The Age discusses a book titled Blind Spots written by Max Bazerman, a professor of business administration at Harvard Business School, and Ann Tenbrunsel, a professor of business ethics at the University of Notre Dame, that discusses the concept of unintentional ethical misbehavior.  They talk about how we can behave unethically without being aware of it by excluding important and relevant information from our decisions.
One of the examples in the article is medical.  It involves a person with cancer who goes to a surgeon who recommends surgery and then to a radiation oncologist who recommends radiation therapy.  It could appear that each specialist is being intentionally self-serving, but they suggest that it is possible for both specialists to genuinely believe that their treatment is superior.  They can fail to realize that their opinions are biased by their training, incentives, and preferences.
It made me think about how I may do the same thing.  As a family physician I have a bias toward treating things I can diagnose as medical diseases with medicines.  I try to incorporate other things such as counseling and physical treatments such as exercises and physical therapy, but since those are not the things I was trained to do, I may not use them as much or as well as I could.  It is easier and more comfortable to prescribe a medicine.  To make ethically sound recommendations about what is in a patient’s best interest we need to be aware of our own biases and be sure to encourage input from others who can see the patient’s needs from a different point of view.

Another Promising Result Using Induced Pluripotent Stem Cells

Last Friday it was announced in Medical News Today that researchers at Johns Hopkins have discovered a means to fix the genetic defect that causes sickle cell disease with the patient’s own stem cells.  According to the announcement, “The corrected stem cells were coaxed into immature red blood cells in a test tube that then turned on a normal version of the gene.”[1]  This does not mean that a clinical application is imminent or that the procedure is safe.  As stated in the original abstract from Blood, the Journal of the American Society of Hematology, “the safety and feasibility of stem cell mobilization in individuals with sickle cell trait (SCT) has not been documented.”  However, the report added that “no untoward adverse events occurred in either group, including sickle cell crises.” [2]

The new treatment could prove to be revolutionary; at present the only existing therapy for sickle cell disease is through bone marrow transplantation.  However, the journal Blood reports that, “many patients are ineligible [for bone marrow transplantation] because of either the lack of a suitable donor or their underlying condition.”  The advantage of “peripheral blood stem cells” (PBSC) from the patient are obvious: patients don’t have to wait for a suitable donor – they are their own source of the stem cells.  The study concludes that, “Products from SCT donors require only minor changes in ex vivo cell processing, allowing for the use of mobilized peripheral blood as a potential source of stem cells for transplantation in sickle cell disease.”  Furthermore, as one researcher stated, “The beauty of iPS cells is that we can grow a lot of them and then coax them into becoming cells of any kind, including red blood cells.”[3]  In short, scientists believe they are now one step closer to successful stem cell therapy for sickle cell disease.

Of course, the word is still out on the success of PBSCs.  But ethicists should applaud any research that is as promising as embryonic stem cell research, but does not require the destruction of human embryos.


[1] http://www.medicalnewstoday.com/releases/235221.php

[2] There were two separate control groups with eight individuals in each group – one SCT group and one non-SCT group.  In the words of the research team, the study does “not permit the conclusion that G-CSF is completely without such risk. Our study, however, suggests that the risk is limited…” http://bloodjournal.hematologylibrary.org/content/99/3/850.full?sid=62767506-48e6-45f1-be88-b033f616fcc7

[3] http://www.medicalnewstoday.com/releases/235221.php