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.”

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!

Thinking about Christian Influence in Public Bioethics: CBHD Annual Conference July 14-16



This week, the Center for Bioethics & Human Dignity will host its 18th annual conference on the campus of Trinity International University.  I hope to see you there.

I have attended the last three of these conferences and each time, I have gone away challenged to think more deeply about bioethics while at the same time encouraged to be about the work of being “salt and light” in a culture that desperately needs “true truth.”  I expect this year will be no different as we gather to contemplate “The Scandal of Bioethics.”

What is “The Scandal,” you may ask?  Well, here’s how the conference organizers describe it:  “Originally conversant with Christian moral reflection, bioethics has emigrated from bedside consultations to interdisciplinary research, public policy debates, and wider cultural and social conversations that all privilege secular discourse.”

Gilbert Meilaender, whom I consider to be one of the most thoughtful and articulate bioethicists (past or present),  put his finger on this shift in bioethics more than a decade ago, commenting “Many of the early figures in the bioethics movement were scholars in the field of religion, and in the several intervening decades bioethics has largely fallen into the hands of scholars trained in other disciplines” (Body, Soul, and Bioethics (Notre Dame: University of Notre Dame Press, 1995), 32).

So too did H. Tristam Englehardt, Jr., another highly regarded bioethicist and scheduled speaker for this year’s conference, in his book The Foundations of Christian Bioethics. As Englehardt observed, “During the 1960s and early 1970s the various Christian bioethics flourished at the vanguard of bioethical scholarship, so that in this period one could not have given an adequate account of medical ethics or bioethics without taking account of the work of Christian thinkers such as Ramsey and Hauerwas. Yet, just as secular bioethics assumed an important role for public policy, Christian bioethics receded in cultural significance and force” ( Exton, PA: Swets & Zeitlinger, 2000, 12).

As we consider “The Scandal” this week, my hope is that we will spend some time in collective retrospection. However tempting it may be simply to look outward in our search for a cause – and certainly, who can deny the secularizing pressures within post-modern culture – I would submit that there is good reason to first look within the camp of “Christian Bioethics.” As for why I believe such to be the case, the answer awaits you in Room 125 of the Rodine building on Trinity’s campus on Friday, 7/15 at 2:10pm.  [yes, this is a shameful advertisement . . . how low one can sink in the effort to boost attendance numbers at his own presentation!!! . . . complicating that effort, however, is the fact that there are some excellent topics for the other papers being presented in that same time slot, including multidisciplinary bioethics, dementia care, posthumanism, among others].

For those of you inclined to do some preparatory thinking in advance of this week’s conference,  I commend the following brief essay for your reading:   Michael Banner. “Introductory Remarks: Christian Ethical Reasoning.” Transformation 1998 (Vol. 15, No. 2, 15-17).


Stem Cells and Fast Pitches

In April 2010, Yankee pitcher, Bartolo Colon, received experimental stem cell therapy to mend torn ligaments in his elbow and shoulder and a torn rotator cuff. The procedure involved taking some of his stem cells from bone marrow and fat tissues and injecting them in the elbow and the shoulder. Since then, he has been back in the game again pitching as he did pre-injuries. The therapy was experimental and was done in the Dominican Republic. And while the Dominican Republic has dragged its heels on releasing Colon’s medical records, things seem to be on the up-and-up regarding this procedure. The MLB commission is investigating whether Colon received any banned substances along with the stem cell procedure as well as whether this procedure is within regulation. (See this New York Times article and this New York Daily News article for background.)

Here are the ethical issues that seem to be presented here:

  • Cheating

Human growth hormone (HGH) is a banned substance that is touted as a wonder drug for the veteran athlete. See this Mayo Clinic article for a brief description on myths and facts about HGH. In short, we all make HGH until we are about forty years old. If a teen or twenty-something were to take HGH, there would be no effect because they are already making the hormone. If a middle-aged person takes HGH, they will notice some slight changes, like firmer skin, scars that disappear, and bones and injuries that heal faster. Their bones and bodies are healing faster, like when they were young – think about the little boy who wears a cast for four weeks versus the middle-aged man who wears a cast for six-to-nine weeks to heal the same type of fracture. The doctor who did the stem cell therapy on Colon is known to use HGH which is illegal for professional athletes. Is Colon covering up the use of HGH by saying that he received experimental stem cell therapy? Maybe he actually did receive stem cell therapy, but did he also use HGH? This is still under investigation.

  • Stem Cells

It is worth noting that since adult stem cells are being used in this procedure, the stem cell source is not morally objectionable. As far as the procedure itself, obtaining bone marrow can be painful, but this procedure is technically minimally invasive. However, it is an experimental procedure, so not all risks are known.

  • Therapeutic vs. Enhancement

This seems to be a therapeutic procedure. I do not follow the Yankees or their stats nearly as much as my Texas teams, but from what I understand, Colon is throwing well, but not necessarily better than ever. He isn’t breaking his own personal record or other pitcher’s records at age 38, including oldest pitcher. He is, apparently, back to his pre-injury skill level. To me this seems to be a therapeutic procedure more than an enhancement procedure, but this is not a clear-cut, black-and-white issue. I wrote an article on the use of anabolic steroids several years ago when the Mitchell Report was out. The steroids make a player’s body do what it was never designed to do. Not everyone was designed to build that much muscle, and the consequences of stressing your joints and ligaments with loads they were never meant to take can cause permanent damage.

The reason why this is not a clear issue is because the therapy is to correct injuries are the result of age and use, but not every pitcher has the same problems as they age. The question is: Is this part of the natural consequences of aging or is it fixing an injury? Is Colon getting an unfair advantage over other players? Certainly, I am less likely to injure ligaments in my elbow and shoulders because it’s not part of my job to use them to their full potential every day. By way of example, however, I am a runner. Not a professional runner, by any means, but does this mean that if I am dealing with a nagging knee injury 20 years from now I should chalk it up to old age? Good-bye track; l hello pool? I do preventative things now for my knees, liking icing and stretching in hopes that I will not have to make that decision later, but some people have bad ligaments and some don’t. As one orthopedist I know said, “Some people have forty year knees, some have eighty year knees.” If there is a therapy out there to fix a knee injury, is it fair for runners with this therapy available to them to use it and compete in races in their age range?

  • The Athletes’ Attitude

The last issue is what I believe gets people a little uneasy about this procedure. It’s the athletes’ attitude. Whether we’re talking about Brett Farve or Michael Jordon or Lance Armstrong or some of the less famous, athletes are who they are because they are not quitters. They will push themselves to the limit and do what it takes to win. But the one foe that they will never beat, no matter how hard they try, is old age. Eventually they are going to get too old to play the sport professionally, and no amount of physical therapy, green tea, and weight lifting is going to stop it. But, they will most certainly try.  I am not a professional athlete (so this might be me stretching), but here’s what might be going through my mind: Is it fair that Colon at thirty-eight years old gets some experimental procedure and now gets to live even one more year in the spot light while I had to go through the difficult transition of retiring at a ripe old age of thirty-five? Is it fair that he gets to wipe away the wear and tear while I never had that opportunity? After all, at 38, your mind is sharper than ever, even if your body is “slowing down” a bit. How much better can an athlete be with experience and maturity under his belt?

Sleepless in Afghanistan

In the June 22/29 JAMA, Dr. Joshua Alley, a surgeon with the 452nd Combat Support Hospital in Khost, Afghanistan, writes eloquently in an essay entitled “Sleepless” of staying up all night treating an enemy combatant severely wounded in a firefight with US troops.  Despite the fact that this patient “wouldn’t hesitate to slit my throat if he could,” the team of doctors works heroically to save his life.  Dr. Alley asks, “Why do we go to such trouble to treat our enemies?  Automatic action?  a trained response?  fear of bad publicity, echoing Abu Ghraib?  the Geneva Conventions looming over our heads?  some Pollyanna notion that when we nurse him back to health, he’ll fall down sobbing and ask for forgiveness for his actions?  a desire for “actionable intelligence” that he might give our interrogators once he’s off the ventilator and talking?


“Maybe some of these thoughts enter my mind, but the reason I went nearly sleepless that night is so that I can sleep all the other nights . . .”


He goes on to write, “One mark of a civilized people is our response to wounded enemies.  Cultural refinements like art, music, architecture, and technology don’t make us civilized.  Some of the most barbaric monsters in human history have been avid subscribers of such refinements.  How we relate to our wounded enemies, though, is our moment of truth. . . ‘Do good to those who hate you,’ we read in Matthew’s gospel.  And tonight, I can sleep, because last night I didn’t.”


It seems that underlying Dr. Alley’s treatment of this bloodthirsty enemy is a recognition that (even if he doesn’t put it in these words) this person, like all others, is a human being, with the dignity that all human beings — even our enemies — possess, the dignity that merits the best treatment he knows how to offer.


I encourage you to read the essay in full, if you can get your hands on a copy of the journal or your institution has online access.  There is powerful truth in what Dr. Alley writes.  Our actions in situations like the one he details do demonstrate what sort of civilization we have, what sort of people we are, what sort of bioethics we espouse, whether we really believe in human dignity, whether we take Jesus’ words seriously.  There are other situations as well that reveal those qualities in us:  for instance, how we treat the poor among us, how we treat the alien, the widow, the defenseless and vulnerable.  As a society, we may do well measured by how we treat our wounded enemies.  But what about the undocumented foreigner who needs basic health care?  Or who is more defenseless and vulnerable than a “disabled” child developing in a womb — or worse, in a Petri dish?  Measured by how we relate to these, we live in the Darkest of Dark Ages, employing a thin veneer of cultural refinements to convince ourselves we are a civilized society.  What an opportunity to be salt and light!  What an opportunity for Christians to make a difference!  (And coincidentally, next week’s CBHD conference will explore the Christian influence in bioethics!  I hope to see you there.)

Politics For the Greatest Good

In yesterday’s post entitled “Ethics and Government–Solomon’s Request,” (if you haven’t read it you should right now) Steve offers a poignant reminder: Being able to discern what is right from what is wrong and implementing those decisions are at the heart of the political life. Ideally, each decision made in the daily grind must be led by wisdom for the whole cause.

I am reminded of Clark Forsythe’s Politics for the Greatest Good: A Case For Prudence in the Public Square. In it he presents a view that moves beyond typical incrementalism and instead promotes prudentialism (a new word–accept it)—making good decisions and implementing them effectively.

He especially directs attention at those who are both religiously driven and politically interested, Forsythe warns, “One of the main temptations of religiously minded, politically involved citizens is letting their zeal race ahead of realism, obstacles, available resources and other constraints.”  After all, “Prudence requires an accurate view of reality and of human nature, both its potential and limits.”

Forsythe calls upon some poignant historical examples of prudential activists—the American founders, Wilberforce, and Lincoln.  He then offers some critical reflection upon Colin Harte’s position in Changing Unjust Laws Justly, which gives him opportunity to further distinguish between compromise and prudence, as well as to further clarify the difference between incrementalism and prudence.  Forsythe’s final section offers practical applications of his view to abortion and other critical issues in biotechnology.

While I would contend that a great deal of his piece boils down to common sense political and public relations, Forsythe’s effort to revive prudence is crucial in the daily grind of political decision-making.


Ethics and government – Solomon’s request

Sometimes today ethics is seen as a very personal thing. Autonomy is emphasized and morality is about a person making the best decision for his or her circumstances.  Solomon’s request when God told him to ask for whatever he wanted reminds us that ethics undergirds the ability to govern well.  Solomon’s response to God in 1 Kings 3:9 was “give your servant a discerning heart to govern your people and to distinguish between right and wrong. For who is able to govern this great people of yours?”  He reminds us that governing well is based on being able to discern what is right and wrong (ethics).  If those who govern choose to believe that there are no objective values and that everyone must do as they see best then it will be difficult to govern well.

May God help those who govern to remember that governing well is based on ethics and being able to discern what is right and wrong.

What Can We Do About Death?

The above title introduces a Hastings Center article about the future of healthcare in America.  It raises the question of what can be done in response to disease, aging and death.  Needless to say, our options are limited.  We can endeavor to stay healthy and extend life, we can take risks and face a premature death, we can be victimized by disease, crime or natural disasters, and we can even choose to die.  But disease and death are inevitable.  The question is, what can a society do when its citizens have unrealistic healthcare expectations that simply cannot be met in our current system?  Daniel Callahan (co-founder of The Hastings Center) and Sherwin Nuland (retired clinical Professor of Surgery at the Yale School of Medicine) suggest that it’s time for America to reinvent the healthcare wheel.  That is, it’s time to reconsider how we view life, aging, and death.  In their view, humane healthcare means a greater emphasis on “public health and prevention for the young, and care not cure for the elderly.”  They even suggest the “cut off” age of 80.  Consequently, individuals under 80 should receive greater healthcare priority over individuals 80 and above.

Callahan and Nuland write:

“The real problem is that we have medicine excessively driven by progress, which aims to rid us of death and disease and treats them as the targets of unlimited medical warfare… That warfare, however, has come to look like the trench warfare of WWI: great human and economic cost for little progress. Neither infectious disease nor the chronic diseases of an aging society will soon be cured. Cancer heart disease, stroke and Alzheimer’s disease are our fate for the foreseeable future. Medicine and the public most adapt itself to that reality, one that has mainly brought us lives that end poorly and expensively in old age.”


“We need to change our priorities for the elderly. Death is not the only bad thing that can happen to an elderly person.  An old age marked by disability, economic insecurity, and social isolation are also great evils.” (

Their bottom line is to focus more on care for the aged rather than costly state-of-the-art curative care.

I tend to agree with Callahan and Nuland.  There are practical matters (e.g., the costs) that must be taken into consideration as well as quality of life concerns.  The thing that troubles me is to establish a specific cut-off age for prioritizing healthcare allocation.  I know individuals in their 80s who are not aging well, but others in their 80s and 90s who are aging very well.  I don’t know what the final answer is to this dilemma, but I think that healthcare allocation has to be based on a case-by-case basis rather than a specific age.  It’s  more complicated to do it on an individual basis, but an age-specific criterion does not take into account individuals who can experience strong quality of life into their 80s and beyond.