Fertility and Cancer

Bioethics is about dealing with the difficult topics, so here is one that I find particularly difficult. The more I learn about the infertility industry, the more opposed I am to IVF and many of the variants of in vitro procedures. The United States has very few regulations on this billion dollar industry, and the risks to mother and child seem to be underreported (See the web site for the documentary, Eggsploitation). Furthermore, I am skeptical of companies that make a substantial profit off of something that is so emotionally laden. Oftentimes, these companies are not up-front with the success rates of IVF, so an emotionally distraught couple is willing to pay thousands of a dollars for a procedure that has a success rate of 30-40% . One couple that I talked to told me that there are bioethical decisions at every step of the process and couples walk in ill-prepared to make these decisions. Many couples are so upset that they may not be in a position to think through these decisions. Personally, I am particularly wary of cryogenic freezing of embryos. There are a number of ethical issues related to this one particular procedure, such as what to do with left over embryos, or how does freezing affect the health of the embryos, considering how very delicate they are.

In general, however, I am also against dismissing certain medical procedures just because they may be used for unethical purposes. For example, I cannot categorically dismiss a DNC procedure even though this is used for aborting a pregnancy. DNC is also used when a miscarriage occurs, and in that sense, it is a much more humane procedure for the death of a baby in utero than the alternative. I also cannot categorically dismiss cosmetic procedures even though some people undergo them for trivial purposes because there are many cases where cosmetic procedures have helped restore a patient’s physical features and facial mobility after accidents or burns.

So, when I came across this article from ABC news about a young woman in her twenties who wanted to freeze her eggs (not embryos) because chemotherapy can cause early menopause in women, I am not sure if this situation can be evaluated from the same ethical categories as a typical IVF case. The young woman wanted to preserve her fertility so she had several of her eggs frozen. She had to take drugs that cause hyper-ovulation, a risky procedure in and of itself, and will likely have to conceive through IVF, although there may be other options available, such as inserting the unfertilized egg into her fallopian tubes.

A news story is one thing. About a year ago I had given a talk on faith and science. After the talk, I met a young woman who was in the audience. She had just recently completed chemo therapy for breast cancer, and was finally trying to put her life back together. She was young, probably not yet thirty and her mom was with her. She told me that she and her husband decided to have some embryos frozen until she was cancer free and was ready to have children. They had to quickly make this decision because, in her case, it was likely that the chemo would affect her fertility. To make the already cloudy ethical waters even murkier, she refers to the embryos as her children. They had apparently only fertilized (or only saved, I am not sure) 2 or 3 embryos, as many as she and her husband planned on having. She referred to them has her children and sees them as such; not something to be discarded or stored indefinitely.

Both of these young women give me pause. Ethical problems abound in reproductive technology. But these women, particularly the second girl that I talked to, do not view these children as commodities. And the technology may very well help them to be able to have children even if cancer treatment might take that opportunity away. Usually I hold a firm stance against IVF, but is this a case where reproductive technologies are less morally tenuous?

On a final note, the ABC article mentions an experimental drug called triptorelin that women can take concurrently with chemo that decreases the chances of infertility (or early onset of menopause) in women. Hormonal drugs always come with risks, however this seems like an ethically robust alternative to an in vitro procedure. Furthermore, this drug is cheaper than freezing eggs or embryos, and thus far seems to be safer than the hyper-ovulation drugs. Also, because tripotorelin can be taken during chemo, chemotherapy does not need to be delayed as it would with freezing procedures.

The Tragedy of Bioethics

At last week’s CBHD conference, a few of us were treated to a unique “Drinking-from-a-firehose” experience.  Jerome Wernow gave a talk with the eyesplitting title, “Bioethics:  Facing a Philosophical Theology of Tragedy and Mystery.”  Intrigued at the title in the conference brochure, but having no idea at all what it might refer to, I slid into a seat in the classroom where Dr. Wernow was to speak, prepared to be befuddled.  Instead, in the space of about about twenty minutes, those of us in the room were given an alluring glimpse into a poignantly beautiful picture for doing bioethics that alters what I see when I look at a patient.

I will attempt to present gleanings from the rich feast that was Dr. Wernow’s talk.  The early 20th Century Russian philosopher Nicloas Berdyaev wrote,  “There can be no moral life without freedom in evil, and this renders moral life a tragedy and makes ethics a philosophy of tragedy.”  As anybody who has witnessed the anguish of those who seek an ethics consult can attest, as anybody haunted by the dark questions our modern technology raises would agree, in bioethics all decisions are fraught with tragedy;  ethics consultants are actors in one-act medical dramas that are tragedies.  And tragedy is neither lessened nor assuaged when good and evil alone are used in bioethics’ calculus.  Our knowledge of good and evil is damaged, the product of a lie (“your eyes shall be opened, and ye shall be as gods, knowing good and evil“); it was in the very act of grasping for the tree of that knowledge that we were banished from the tree of life.  When we approach people whose stories have taken a catastrophic turn and we wield only the calculus of good and evil, our bioethics is left lifeless, empty, and tragic.  According to Wernow, to address tragedy we must turn to mystery, to “Mystery-revealed:” Christ, in whom is Life.  The question we ask as Christians doing bioethics is not just, “What is good?” but “How do I bring eternal life into this tragedy?  How do I bring the mystery of Life into the abyss?”

There was an amazed silence in the little classroom when Dr. Wernow finished.  Unfortunately, that is all I can leave the reader with.  I am not even sure that in my pathetic summary I presented Dr. Wernow’s vision remotely accurately;  his ideas poured out quickly and passionately, I could take only skeleton notes, and he has not as yet published an article or book that sets out the implications of the “Philosophical Theology of Tragedy and Mystery.”  But I sure love his vision of bioethics-as-drama instead of as sterile philosophical specimen;  and I can embrace the quest to bring the Mystery of Life into tragedy as a robustly and profoundly Christian way to engage and immerse myself in the tragedies of a fallen world.


Faithful presence

The CBHD conference last week was one of the best since I began attending in 2007.  One of the things that has stuck with me and that I am continuing to think about is Dennis Hollinger’s thoughts about living in the world in faithful presence, an idea he attributed to James Davison Hunter and his recent book, To Change the World. Hollinger said that the foundation of Christian bioethics is our Christian worldview which many in our society do not share and will not accept.  When we look at how we can try to translate the bioethical good that we are able to understand from our Christian worldview into a world that does not accept that starting point he suggested living in the world in faithful presence.

He indicated that there would be several characteristics of that approach.  We would focus on honoring God and loving our neighbor.  We would have modest expectations of our impact on our culture consistent with the Biblical metaphors of salt, light and leaven.  We would need to be bilingual, speaking in a thick fuller language to those who will accept God’s truth and a thin less complete language to those who will not.

I have been thinking about what it means to live in faithful presence in relation to bioethics in our society.  For me it includes caring for my patients compassionately and trying to be better at preparing them for the difficult places in life.  It includes helping my online bioethics students understand what a Christian worldview is and how it applies to the issues they will face in life.  It includes helping students on the Taylor campus see how their faith and how they live fit together.

What does it mean for you?

To know one’s fate or not to know?

In the Greek tragedy Prometheus Bound (attributed to Aeschylus), the priestess “Io” pleads to Prometheus, “Oh hide not from me what I have to suffer!”  Prometheus responds, “it is better for thee not to know…seek not thou to know thine own fate.”  A few hundred years later Cicero opined, “Moreover, often it’s not even advantageous to know what’s going to happen; for it’s wretched for a man to be tortured when he’s powerless to do anything about it, and to lack even the last consolation of hope, which is available to all.”

These ancient words of wisdom should be heeded by neuroscientists who venture to diagnose Alzheimer’s disease years before more severe symptoms of the disease begin to appear.  They refer to this newly discovered stage of Alzheimer’s as “preclinical Alzheimer’s disease.”  Indeed, it seems reasonable to think that Alzheimer’s is not something that occurs suddenly in old age, but over an extended period of time before the advent of critical memory loss.  And if this is the case, then it stands to reason that scientists may acquire the ability to detect it in its preclinical stage.

I have two concerns:

1)  How accurate is the diagnosis?  According to Kenneth Covinsky (who holds the Edmund G. Brown Sr. Professorship in Geriatrics in the University of California, San Francisco, Department of Medicine), “The guideline for preclinical Alzheimer’s disease is emphatic that the state of the science is not good enough to diagnose this stage in clinical practice.”  In other words, scientists currently do not have the capacity to truly diagnose Alzheimer’s at a preclinical stage.  But Covinsky warns that the essential problem with early diagnosis is that it “labels people who have completely normal cognitive function as having an illness. A key question is whether using this label will make patients better off.”  Some additional problems include evidence that individuals with “preclinical Alzheimer’s disease” may not actually contract the disease.  According to Covinsky, “many, if not most, people with these biomarkers will never get Alzheimer’s disease. For example, autopsy finding suggestive of Alzheimer’s disease are commonly found in people who never had symptoms.”  Furthermore, because “the link between the biological markers of the disease process and the clinical expression of the disease is highly variable,” Covinsky believes that “it is unlikely that we will ever be able to tell the vast majority of cognitively normal patients for sure whether they will develop Alzheimer’s disease.”  (The Hastings Center Report, Bioethics Forum, July 15, 2011).

2)  My second concern is with the potential moral dilemmas that emerge from the diagnosis of a pre-symptomatic illness.  Suppose you are told at a very early age that you are at a high risk for Alzheimer’s disease?  The question is, do you keep that information to yourself, or do you divulge it to others?  Are you morally obligated to inform a future spouse or employer of your “preclinical disease?”  So, even if it becomes possible to determine that an individual has “preclinical Alzheimer’s disease,” is it really a good idea to know this information?  Perhaps it is, if treatment is available.  Until then, we should follow the advice of Prometheus and Cicero and choose not to know.
Read more: http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=5454&blogid=140&utm_source=constantcontact&utm_medium=email&utm_campaign=bioethicsforum20110718#ixzz1SYxUAK7p

“The Scandal” Examined

As advertised in my last blog, the CBHD conference that concluded this past Saturday gave participants much to consider and much encouragement in being about the task of “doing” Christian bioethics. The combination of a highly relevant topic, excellent speakers, and an engaged audience made for a great conference, perhaps the best that I’ve attended over the past 4 years. For those CBHD staff and leadership reading this blog:  Thank You for all of your hard work!

As I mentioned before, the topic of the conference was “The Scandal of Bioethics,” by which it was meant the diminished theological voice in public bioethical discourse. Several speakers affirmed the reality of a secularized public square that is increasingly hostile to a theologically grounded bioethics, yet, there was no room for defeatism. Rather, conference participants were encouraged to persevere and there was much positive discussion on the shape and content of a Christian bioethics.

As I reflected on “The Scandal” in preparation for my paper presentation, it occurred to me that there is really a scandal within “The Scandal.” Specifically, it is the facilitation of secular bioethics by those claiming the label of “Christian theologian.” In my paper, I focused on the introduction of the personhood distinction, a staple of secularist bioethics, by then-Episcopalian-theologian Joseph Fletcher in his 1954 book Morals and Medicine. I argued that what Fletcher really was doing was not Christian theology, but speculative philosophy. And so too many Christian ethicists today as they build their ethics around human personhood, social justice, or a presumed common morality, to name but a few cherished starting points.

It is one thing for an unbelieving culture to deny Christians entry to the public square, but quite another for Christians to excuse themselves, be it through separatism or accommodation. Christians must be willing to remain engaged, but with a bioethic that faithfully represents the moral truth that God has graciously revealed in Scripture. Such is our duty and privilege in the larger context of the wonderful Christian mission

Is a CT Scan an Ethical Issue?

All third-year students at Texas A&M are required to attend Saturday-morning radiology lectures, and I was surprised to hear my professor speak for the final 30 minutes yesterday on when not to order imaging.   Radiology is his life’s calling, but he recognizes that imaging studies like the CT scan can be harmful.  Of the $2.3 trillion spent on healthcare in the U.S., the largest share is spent on imaging, totaling $800 million.  CT scans have become a part of the American vernacular, but it is estimated that 1/3 of them are unnecessary.  What ethical issues concern the use of imaging in healthcare?

  • Patient Safety: Concerning chest scans, an X-Ray exposes the patient to 0.1-0.2 mSv of radiation, but the CT dose is 8.0 mSv.  At 50 mSv a person is at increased risk of cancer, so minimizing the number of exposures to a CT scan should be an important goal in healthcare.
  • Cost: Some of the ballooning in healthcare costs over the last decade is due to tests ordered by physicians.  Many doctors order tests not because they are indicated by the patient’s symptoms but because they serve as an extra layer of protection in the case of a lawsuit.  The irony of such defensive medicine is that one day a doctor may find himself in court for exposing the patient to too much radiation.  Patients never see the thousands of dollars of imaging charges, so they often authorize such studies and let the insurance companies handle the rest.
  • Physicians Lining Their Pockets: Research has shown that physicians increase the number of scans ordered when they are able to bill for the use of their own equipment.  One gastroenterologist related to me how his clinic moves a number of unnecessary endoscopies through his office for various reasons.  An endoscopy does entail some risk and is certainly not comfortable, but every CT scan is sure to expose the patient to radiation.  Physicians should refrain from allowing revenue strategies to trump good medical practice.

For more information on radiology, visit www.radiologyinfo.org.

STEPS in the wrong direction

One of the major tasks of bioethics since its inception has been to ensure the ethical conduct of scientific experiments involving human subjects.  One of the cornerstones of ethical experimentation (indeed of all medical treatment that respects the human dignity of the patient) is the concept of informed consent:  the study participant should know up front the purpose, potential benefits, and potential risks of participating in the study.

In the 1990’s, Parke-Davis, the manufacturer of the anti-epileptic medication Neurontin (generic name: gabapentin), conducted a trial called Study of Neurontin:  Titrate to Efficacy, Profile of Safety (STEPS).  This was a Phase 4 trial (performed after the medication was already on the market) whose professed objective was to study the efficacy, safety, tolerability, and quality of life among gabapentin users as the drug’s dose was increased.  Parke-Davis recruited physicians to enroll patients into the trial;  in all, 772 physician-investigators enrolled a total of 2759 patients into the trial.  The study resulted in two published papers.

It all sounds innocuous enough, no?

Recently, through legal action, all of Parke-Davis’s internal and external documentation relating to STEPS became available for review.  In these documents, a different picture of the trial’s objective comes to light.  A few quotes from the company’s internal memos:

– “Some indicators of [the study’s] success include 20% increase in new patients’ starts in March and a 3% market share in new prescriptions. . .”

– “STEPS is the best tool we have for Neurontin and we should be using it wherever we can.”

– “. . .at the very least, we should be looking to place as many managed-care patients as feasible in [STEPS] to prevent Lamictal [a competitor’s drug] starts.”

– Multiple strategic planning documents cite the STEPS trial itself, not the trial’s findings, as a key marketing tool for gabapentin.

– Parke-Davis monitored and analyzed the physician-investigators’ prescribing habits, finding increased prescribing of gabapentin among STEPS participants compared to a control group of non-participants.

Apparently, contrary to the trial’s stated objective, the purpose of STEPS was not science, but marketing;  the true subjects of the trial were not the patients, but the physicians.  The most important measured outcome of the trial was not the safety or efficacy of gabapentin, but whether and how much doctors changed their prescribing behavior as a result of participating in the trial.

Is this an ethical trial?  Some might say, sure, there was nondisclosure of the true intent of the trial, but c’mon, it wan’t Tuskegee, right?  I mean, nobody was hurt (unless you count the 11 patients who died, the 73 who experienced serious adverse events, and the 997 who experienced less serious adverse effects).

No, this was an unethical trial.  There could not be informed consent, as the true purpose of the trial was not revealed to physicians, patients, or IRBs.  In addition, using any human being in such a deceptive manner for monetary ends is inconsistent with respect for human dignity.


An article that reviewed STEPS and provided the quotes above appeared in the June 27 Archives of Internal Medicine;  the abstract can be accessed here.


Cancer, Hold the Chemo

Admittedly there are some things that I would never conceive could possibly “run out” or “dry up,” even in the worst economic times. As a non-doctor, drugs are one of those things.

But imagine, if you will for a moment, having to call your friends to see if they could get you the much needed drug that your hospital could not supply. If you do not get the drug, you will not be able to keep your disease under control…

This is exactly what happened to Thomas Kornberg, a professor with Hodgkin’s Lymphoma who was forced to contact doctor-friends to supply his need.

The American Hospital Association just issued a press release showing the results of their recent survey that exposed this apparent drug shortage:

  • Hospitals report that they have delayed treatment (82%) and more than half were not always able to provide the patient with the recommended treatment
  • Patients got a less effective drug (69%)
  • Hospitals experienced drug shortages across all treatment categories
  • Most hospitals rarely or never receive advance notification of drug shortages (77%) or are informed about the cause of the shortage (67%)
  • The vast majority of all hospitals reported increased drug costs as a result of drug shortages
    • Most hospitals are purchasing more expensive alternative drugs from other sources

The AHA has proposed some solutions: They want to establish early warning systems of shortages, remove regulatory obstacles, improve communication among stakeholders, and explore incentives to encourage drug manufacturers to stay in, re-enter or initially enter the market.

Clearly Kornberg is not the only case,

So what happened to the other people who don’t have the connections/resources that he does?

How are hospitals to deliberate on the dispersion of scarce resources?

Even more concerning, if this becomes a trend, will there be an even larger motive for inconspicuous sales?


Solomon and bioethics (and prayer)

I’m still thinking about Solomon.  I keep coming back to the idea that when God told him to ask for whatever he wanted Solomon responded “give your servant a discerning heart to govern your people and to distinguish between right and wrong” (1 Kings 3:9 NIV).  I wrote about the governing part last week, but I keep thinking about his request that God give him the ability to discern between right and wrong.  That is the essence of what ethics is all about.  Solomon was given that ability because he asked God for it and was considered the wisest person on earth.

The word we use for asking God for things is prayer.  I think we sometimes forget the connection between prayer and ethics.  It is true that ethics involves our ability to reason, and what we can learn at a place like Trinity is very valuable, but prayer is a key that opens a connection with the one who knows all things and is the source of all we can know about right and wrong.  If we want to be able to discern what is right and wrong we should ask God for his help.

In light of the theme of the CBHD conference opening tomorrow let us remember that Christian influence in bioethics and our society will not come about solely by the power of our intellect, the persuasiveness of our arguments, or our political strength.  We will influence bioethics and our society when God uses us and the abilities he has given us as instruments of his power in causing his will to be done.

Join me in praying for all those involved in the conference and all of us, whether we are able to be at the conference or not, who are Christians concerned about bioethics.  Pray that God will give us the ability to discern what is right and wrong and help our society to do the same.

Scientific Sophistry

Plato and Aristotle were well acquainted with the art of sophistry.  Plato referred to the sophists as “image makers” and Aristotle observed that the sophists taught the skill of “making the worse argument seem the better.”  In other words, sophistry is the art of using language for the purpose of persuasion, but not necessarily to communicate truth.

Recently EuroStemCell (a European stem cell consortium) reported its concern about the European Court of Justice’s potential ban of patents that utilize human embryonic stem cells.  To respond to the European Court of Justice, scientists are invited to sign a letter in protest against a possible ban of patents that employ hESCs.  The letter contains the following reasoning:

“Embryonic stem cells are cell lines, not embryos. They are derived using surplus in vitro fertilized eggs donated after fertility treatment and can be maintained indefinitely.” http://www.eurostemcell.org/commentanalysis/open-letter-stem-cell-patent-case-could-have-far-reaching-impact

It is as if by highlighting the obvious, i.e., that stem cells are not embryos, that the destruction of human embryos is not part and parcel of deriving stem cells in the first place.  Instead, scientists simply make use of “fertilized eggs,” again, a reluctance on their part to acknowledge that fertilization of the ovum is where human life begins.  Or, that the stem cells are “derived using surplus in vitro fertilized eggs donated after fertility treatment,” as if the use of leftover embryos justifies the endeavor.

And, just in case anyone throws out the “but what about induced pluripotent stem cell research” objection, the letter cautions that iPSC research is “still imperfect,” implying that hESC research is closer than iPSC to perfection.

And finally, the letter contains a scare tactic for good measure.  The concern is that “European discoveries could be translated into applications elsewhere, at a potential cost to the European citizen.”

So there you have it!  The letter performs linguistic gymnastics to obscure an procedure that destroys human life but shows less potential than iPSC and adult stem cell research.  Sophistry at its best!