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.

End of Life Preferences

At the end of life, there are few easy decisions; especially as our ever-expanding capacity to extend life becomes, well, even more ever-expanding. Our ability to extend life is not without consequences. We must consider, among other things, the quality of life, the inherent value of life, the reality of death and, frankly, when enough is enough.

In a study published a couple of weeks ago in the European Heart Journal, a group of physicians set out to determine the “End of Life Preferences of Elderly Patients with Chronic Heart Failure.” The conclusions were not as they expected. Of the 555 patients who were asked if they would be willing to accept a shorter life span in return for living without symptoms 74% were not willing to trade survival time for improved Quality of Life.

If you were given the choice between a shorter life without symptoms and a longer life with them, what would you choose?

Stealth ethics

I was recently talking with some students about how to be effective in teaching students how to apply Christian ethics to how they live their lives. They suggested that for a significant number of students it would be most effective if we did not tell them that we were teaching ethics. They thought that there were many students who would think that anything labeled as teaching ethics was something negative or of little interest to them, and they would not choose to be involved. They suggested it would be better to focus on topics of interest to students in their daily lives and incorporate teaching ethics into the discussion of those topics without identifying ethics as the topic. My own label for their idea was “stealth ethics.”

As I thought more about what they had said I began to wonder if it was ethical to teach ethics without openly stating that you were teaching ethics. My wife says I am the only person she knows who thinks about things like that, but I think she just doesn’t know enough ethicists.

My conclusion was that it was possible to do what the students were suggesting in a way that would be ethical and positive. Using the word “ethics” or the word “morality” is not necessary when we teach ethics and morals. Our desire is to get our students to think about why they do the things that they do and to learn to find standards to live by that are based in God’s revealed truth. If they can learn what God has to say about the value of every human life and how to treat every person with love and respect, and place obedience to God and caring for others first before their own desires we will have succeeded in teaching ethics. There will be those students who want to go deeper and understand how to discern Christian ethical values more rigorously and how to express that understanding to those who do not have a Christian foundation. They are a joy to teach. But my desire is that every student would have an understanding of how to live by God’s standards whether they call it ethics or not.

Reflections from the Front: Pre-Marital Counseling

Reflections from the Front: Pre-Marital Counseling

The Doctor-Patient relationship, autonomy. Some times our patients invite us into places where angels fear to tread. We can’t rush in. But if invited in, we must consider carefully the sacred responsibility and the cowardice of refusing to attempt to help. God and society have granted us this position as a trust. We have no right to abuse this trust by acts of omission or commission. (CSP Vol. 43 No 2, 2000)

 

I am a neurologist.

I don’t do pre-marital counseling.

Yet, here they were in front of me: Tom and Sally.

 

Tom had been my patient for years.

He was partially deaf, and mildly retarded.

I treated his intractable seizures, and Migraine headaches.

Recently, we had proven that these all were part of a larger syndrome*—

That would kill him in the next few years.

He had called and asked if I would meet with them.

 

Sally was new to me.

She had cerebral palsy, with impaired legs, but a good mind.

Sally was plain, and vaguely eccentric.

But she had a good sense of humor.

 

Tom was her first boyfriend.

They talked on the phone for hours.

They both claimed to be in love.

They both had thought and prayed about this decision for weeks.

But Tom’s mother was quietly opposed.

 

What did I think?

They really wanted to know.

 

We talked for over an hour.

Were they unrealistic?

Were they blinded by their first love?

Could they imagine the pain they would share?

I probed as gently as I could.

 

No cliché–I felt honored and immensely humbled.

 

“No,” I told them.

“I don’t think you are blind or unrealistic.

But I think you have no idea how much pain you are in for.”

 

(Do any of us when we deeply love someone?)

 

Tom died in stages over the next two years.

But not before they shared true intimacy,

            Marital sexual union, and

                        Some good times together.

 

Sally said:

            “It was terrible, but wonderful.”

 

I thought:

            “How like the best of marriages.”

 

[* Tom had MELAS, Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-like Episodes. MELAS is a maternally inherited, progressive, incurable disease.]

 

Need money? Can’t afford medical supplies? Enroll in a Clinical Trial

I was reading through Bioedge newsletter (a great newsletter for bioethics news updates) , and came across an article on people enrolling in clinical trials for additional income. Several of the participants that were interviewed, said that they searched the internet for clinical trials, and responded to ones that they were interested in. Many of these people will participate in two to three clinical trials per year. Some of them have criteria for what kinds of trials they are willing to do, such as one participant who does not take drugs that may affect the brain, heart, or have severe side-effects. Several of the participants report that by doing these trials they were able to receive medical care or medical supplies that they would not have had otherwise. Also, many people who enroll in clinical trials end up having conditions such as cancer or hepatitis that would not have been detected had they not participated in a study. Personally, I knew a guy that enrolled in a ten-year heart study. He had to wear a pedometer and went in for tests and evaluations that would cost any other person thousands of dollars.  He thought it was a great deal and was glad to help with a study.

In many ways this seems like a great deal. I certainly sympathize with the scientist’s perspective of wanting volunteers to assist in clinical trials. Even though scientists can test and re-test and continue evaluating the effects of these drugs in animal trials, eventually it needs to be tested in human beings. By the time a drug has reached this point, though, it has been through extensive testing in animal studies. Also, these patients seemed to have had good experiences in participating in clinical trials.

However, financial compensation in medical procedures is always a cause for concern. I do think people should be compensated for their time and trouble. I also think that if insurance does not cover any harm that may occur in a clinical trial, the patient should be compensated by the company. But with compensation comes the risk of exploiting certain socio-economic groups or the vulnerable. These trials are voluntary, but, as with the case of a mother who had diabetes, the trials provided the medical supplies that she could not otherwise afford and it provided additional income that she needed. This doesn’t sound bad. In her case, it seemed to have worked out well, but there is still concern for people that are in medically or financially desperate situations. Some trials place a patient at a greater risk than others. As Arthur Caplan mentions in the ABC article, the amount of money the patient receives for participating is a good indicator of the potential risks. The compensation may entice financially strapped individuals into putting themselves at a greater risk than they would have done otherwise.

A second consideration is that clinical trials do not replace going to the doctor, or receiving medical treatment. This caution was touched upon in the ABC article, but merits some elaboration. Not all clinical trials are testing efficacy. This is an important point for people that have an illness that they are hoping will be alleviated or cured with these new trial drugs. Phase 1 clinical trials usually test for side effects, therefore some patients will not receive a strong dosage and some patients will likely receive a placebo. From what I understand, patients are told up front that they may receive a placebo and this part of the clinical trial is for toxicity or side effects, not for efficacy, but certainly with certain trials patients are hoping for something more.

Additionally, participating in a clinical trial is not the same thing as going to a doctor. The researchers are looking for specific things having to do with the drugs that they are testing. While they will often find other problems in the process of clinical trials, that does not mean they will catch everything. For example, my friend that is in the heart study gets very expensive tests for his heart and cardiovascular system, but the doctors may not catch a digestive disorder or a tumor in another system. It just depends on what they are testing and the extent to which they are examining the entire body. Generally, by the time a drug has hit clinical trials, researchers have a good idea of what systems will be targeted and what side effects will likely occur.

A third consideration, not covered in the ABC article but addressed in this Business Week article, is recruitment. Drug development is a very expensive endeavor and often the drug company loses money at the clinical trial level because it cannot find volunteers to fit the study’s criteria. Hospital medical records provide a way to filter patients who may be good potential candidates. This is a good idea, in theory, but raises privacy issues.

In sum, clinical trials have provided people with medical supplies, supplemental income, and in some cases, diagnoses that they would not have received otherwise due to various factors, including economic ones. However, compensation may entice some people to place themselves at a greater risk that they would have done otherwise, and clinical trials do not replace going to a doctor or receiving needed medical treatment for a condition. Finally, the drug company has an economic incentive to recruit people with particular qualifications to do trials, but in order to obtain this information, privacy issues must be considered.

Human trial is always a sticky subject and raises several questions about how we can best respect the rights of the human trial subject while still adequately testing a particular drug for treatment.

Down Syndrome and Thanksgiving

 

Despite today being the retail abomination known as “Black Friday,” I will continue in the vein of Thanksgiving and write about a person I am thankful for.

My nephew’s name is Jacob, and he has Down Syndrome. He just turned 18. He is one of the most loyal and loving people I have the privilege of knowing. He gives incredible, bone-crushing hugs. His cell phone voice mail message ends with, “Love you.” His aunt, my sister, lies in a nursing home, barely able to interact since a brain injury in June; but Jacob doesn’t care about her medical conditions, he just loves to be there with her, because he loves his aunt. I am thankful for Jacob’s example of unconditional love.

When we take Jacob out to eat, he orders french fries. And when he eats french fries, he eats them a certain way, one at a time, dipped just so in his favorite condiment: steak sauce. Lunch takes at least an hour. I am thankful that Jacob makes us slow down. 

Jacob loves music. He owns several guitars, and received a bass guitar for his last birthday. He especially loves worship music. He can strum his guitars, although a guitarist probably wouldn’t call it “playing” guitar. His singing isn’t exactly on key. Yet most Sundays he is in front of his church leading worship with the worship team. His microphone may not be turned up terribly high, but his love for Christ is at full volume. I am thankful for Jacob’s example of unselfconscious worship.

Jacob sometimes requires extra patience. His parents have made extra sacrifices. There are things he does that will drive you crazy if you let them (Is there anybody for whom that is not true?). He will never live independently, and will always require a level of extra care. But the extra care and patience are richly rewarded. And while we think we are making extra sacrifices for Jacob, I sometimes think that God sees it differently: that He is giving us an extra measure of blessing by allowing us to be with Jacob. Yet it seems that too many, when they think of “Down Syndrome,” think only of the extra work and sacrifice and limitations. Either that, or they think of a life that is not worth living. Whatever the thinking, it is both sad and frightening that in this country, about 92% of the unborn babies suspected (on the basis of prenatal testing) of having Down Syndrome are aborted: sad, because of the loss of human life through abortion as well as the loss of the privilege of being with these unique people; and frightening, because of what it says about us as a society. I am thankful that Jacob was not one of the 92%.

Seven things I am thankful for

With Thanksgiving being celebrated tomorrow I have been thinking today about things I am thankful for in the context of bioethics. So here is my list of seven things I am thankful for this year.
1. Students who really want to learn how to make ethical decisions.
2. Medical technology that is effective enough that we have to make decisions on when to stop using it (much better than not being able to do anything for those with serious illnesses).
3. Palliative care for those who are suffering, particularly at the end of life.
4. The amazing miracle of the birth of a new life.
5. People who care for unborn human beings and their mothers.
6. The impact of prayer in people’s lives.
7. God, who made us to be enough like him to be able to have a relationship with him and to bring glory to him.

The Tangled Knot of Biomedicine

“I believe this will be the biomedical century,” he continues. “We’ll look back a hundred years from now and say the 20th century was the century of chemistry and physics, and the 21st century was the century of biomedicine.” – John Lechlieter (CEO of Eli Lilly & Co. in a Wall Street Journal interview)

Health, medicine, tailor-made drugs, genetic markers, genetic predispositions, obesity, screening, healthcare – turn on the news, or open a newspaper (or web browser) and you will find articles on all of these topics.  This is the biomedicine century that started with sequencing the human genome and has been going full force since then. The next great cure is always (seemingly) around the corner. However, with every achievement there are often more questions that need to be answered. Recall the NOVA special where scientists said that the human genome is like a parts list for a Boeing 777. Having the parts does not mean you know how the plane flies, but it is a first step in understanding how the plane works.

Unfortunately, answering questions means research and research costs money. I was trained as a chemist at a university that focused on industry, so I learned a lot about the industrial side of things. I don’t think “Big Pharma” is all bad, but there is this tangled knot of politics-money-health-patents that is difficult to decipher. In this interview Mr. Lechleiter laments that fewer numbers of companies are looking at the same problems and there is push for developing big selling drugs after the patents have expired, as opposed to creating new drugs:

This strategy is in marked contrast to many of Lilly’s peers, which may also help to explain those P/E ratios. Over the last decade, most of the industry has been slashing research and development in favor of M&A and megadeals; many of the blockbusters coming off-patent were created by companies that no longer exist. “One current challenge the industry faces is that the wave of consolidation really leaves only about a dozen multinational pharma companies that have global reach. That’s it,” says Mr. Lechleiter. (Down from 30 or more not so long ago.)

From a business perspective, making a Lipitor-like drug is certainly more lucrative than developing a cure for a disease that only affects a fraction-of-a-percent of the population.  However, thinking in those terms, just seems a bit cold and calculating. It does not seem fair to those with the rare diseases. Yes, high cholesterol affects more people, and yes, the biggest fires are the ones that are put out first, but how can less popular research be done? Is government funding the answer? Is non-profit fund-raising a solution? Private investors are interested in applications, but before we can apply new techniques or use new compounds, sometimes we need to understand the fundamental properties. In chemistry, government funding has helped fund fundamental research, however, with government funding, comes the political side of things. Not all research is politically neutral. Furthermore, these less popular diseases do not make for a large voting percentage. I’m not trying to be cynical. I want to look at the complexity of factors that go into pharmaceutical research and development and certainly politics is one of them. Money is another. Private investors want a return on investment.

This is big business and big politics that tugs at our heart strings. If we were going to improve the system where would we begin? Mr. Lechleiter suggests that the FDA regulations need to be updated for genetically-specific drugs. Some people think the whole patenting process needs to be improved. I, personally, am a fan of open-access research articles. Other solutions might include drug companies not giving doctors incentives for prescribing their drug. Or maybe drug companies should receive incentives for research in rare diseases. What do you think – what is one thing you would change about the pharmaceutical industry?

A busy week for stem cells

Two bits of news from the world of stem cells this week:

First, Geron, the California company conducting the first ever official study using embryonic stem cells in humans, has suddenly terminated the study. Geron cited economic factors as the reason for stopping the trial. The study involved spine injury patients; Geron said only that the therapy was well tolerated, with no serious adverse events.

Second, a study using “adult” stem cells from patients’ own hearts to repair their own damaged heart tissue has produced promising results. The study’s purpose was not to show that the use of the cardiac stem cells was effective, but to make sure that the process is safe (the Geron study was also a test of safety); but study subjects receiving their own stem cells have already shown improvement in heart function.

Daniel Heumann, of the Christopher and Dana Reeve Foundation, said of the halted Geron study, “I’m disgusted. It makes me sick. To get people’s hopes up and then do this for financial reasons is despicable. They’re treating us like lab rats.”

The authors of the adult stem cell study, while warning that the results of the trial needed confirmation in larger trials, called the initial improvement in cardiac function “very encouraging.”

Geron has invested tens of millions of dollars in embryonic stem cell therapy in the past decade.

Even if one does not believe that it is unethical to destroy our offspring to find cures for our diseases, one should at least acknowledge that spending tens of millions of finite research dollars for an agenda that repeatedly uses reckless hype to gets people’s hopes up, only to dash them, is an unethical option when compared with funding “encouraging” research with a proven track record of producing successful treatments.

Twentieth Anniversary of Darwin on Trial

Aside from my work in bioethics, I have worked in the area of science and culture, in general, and intelligent design, in particular. Intelligent design is a paradigm that 1) allows for non-naturalistic explanations of design in nature and 2) seeks to detect design in nature. Much of the early ID literature was devoted to countering methodological naturalism, a worldview that presupposes only natural phenomenon and explanations. This worldview had a stronghold in our culture and in academia. The rules of the game excluded any non-naturalist theory from being an active contender in the market place of scientific ideas. However, evidences were mounting that showed the narrow range of acceptable explanations needed to be extended. In other words, there were some observations in nature that cannot be explained from naturalistic presuppositions.

In 1991, UC Berkley Law professor, Phillip Johnson, wrote a little piece entitled Darwin on Trial. In this book, he brings Darwinian evolution to task as being a theory motivated more so by a commitment to methodological naturalism than to scientific evidence. Not all aspects of evolutionary theory were wrong. We see small-scale changes that involve adaptation to environmental pressures all of the time. We see changes in populations due to fitness in a particular environment. However, this is not what Darwin proposed. Darwin provided a naturalistic origins story that takes the observations of microevolutionary events and extrapolates them out to large-scale events that explain the origins of all of the organisms that we see today. Darwin was operating on a worldview that removes any supernatural or non-natural events from the picture.

These distinctions were not always so clear. It was Johnson’s book that first put teeth on the rhetoric. Yes, there was something different between the microevolutionary events that were observed and the extrapolations to account for origins and creativity, but it was difficult to untangle the knot of science, philosophy, worldviews, and religion. Johnson did that. He wasn’t the first to address these issues, but he certainly got the ball rolling. Using his adept skills as a lawyer, he carefully untangles the knot through discourse, examples, and analysis. He framed the debate.

Today, a new web site is being launched in honor of the twentieth anniversary of Darwin on Trial. Whatever your views may be on evolution, Darwinism, and intelligent design, the information content in DNA, the fine tuning of the universe and the irreducible complexity of molecular machines demand an explanation. Methodological naturalism does not provide an adequate framework to explain these phenomena, so perhaps we need to adjust our framework. I encourage you to explore this web site about who provided the spark that set “the match that lit the tinder beneath a stockpile of dry logs” of mounting evidences.

 

 

As a note: While this post does not deal with bioethics directly, it deals with worldview issues which affect how we approach bioethics. Methodological naturalism and Darwinian evolution inform our views on anthropology. Much of Darwin’s work in Descent of Man discusses the implications of his theory coupled with his worldview presuppositions for man and morality. By definition, methodological naturalism rejects supernatural explanations and therefore non-natural criteria for personhood.