Preschool Assent?

In my draft, I brought up the idea of informed assent. It obviously does not apply to babies, and therefore will not be appearing in my final draft. However, it does raise some interesting questions. In particular, when does informed assent become possible?

We discussed this briefly in class, and Professor Zwicker told us that most studies give the age of seven. However, I came across a few studies in which researchers attempted to obtain informed assent from preschoolers. The research was not clinical, and involved almost no risk (it was merely observational), so there were no ethical worries in using proxy consent from parents. Nonetheless, the researchers did get some very interesting results.

Most of the children proved to be very capable of understanding the research and giving permission for it to go ahead. In one of the studies, one boy asked if he would still be allowed to play outside (Flewitt 3). This may seem a petty concern, but it indicates that he was thinking of how the study would affect his life. In this context, it seems much more advanced than one would expect.

The question still remains though: is this a sufficient indication that the children have the mental ability to give informed assent for medical research? It is hard to say. They are obviously capable of thinking on a similar level, but it is not clear that their abilities will extend to the life and death issues involved in clinical trials. So what do you think?

Research article: http://web.ebscohost.com/ehost/detail?vid=1&hid=116&sid=a6d94318-20c3-47fb-9bc9-dfa5088d1e50%40sessionmgr109

Woman Begs French President for Right to Die

A woman named Chantal Sebire of France recently issued an urgent plea to French President Nicolas Sarkozy concerning her death wish.  Chantal Sebire, former school teacher, has a rare cancer related to the nasal passage ways.  Unfortunately, due to metastasis spurring the growth of enormous facial tumors, she has been left permanently disfigured.  It is not these cosmetic reasons however which have led Sebire to desire death but rather her poor quality of living and suffering.  Initially, she lost her sense of taste and smell and then later also lost her sense of sight.  She can't bear to go on, saying "[even] an animal would not be allowed to endure what I have to endure."  

Here is the catch:  euthanasia is illegal in France. 

Her only hope was to contact the president to make an exception.  Should he have this power?  Should one stroke of his pen decide whether or not this woman dies?   Does she really have a right to die in this case?  Or should the law deny her of this freedom, essentially "protecting her from herself?"

Personally, I feel as if such matters should be considered on a case-by-case basis.  Looking at this case, I think that she has a valid point.  Her suffering is so immense, both emotionally and physically, that I believe she should have a choice of whether or not to continue to endure such pain.  When thinking about this, I recommend first coming to a conclusion based on what I have summarized and then looking at the link below to view a picture of the woman, which is quite graphic.  I believe the photo definitely had an impact on my viewpoint and may have an impact upon your own.  

link to article

Ethical Discussions

Reading “Unspeakable Conversations” by Harriet Johnson this weekend made me start to think about why we debate ethics, and what there is to gain from a discussion with no clear right or wrong answer. Ethics is a sea of gray. Every post in our class blog can be argued from different angles based on people’s views and assumptions, but through these posts and discussions arguments are adjusted and views are modified. The point isn’t, I don’t think, to necessarily change others’ opinions but rather to learn to clearly articulate and defend your own stance.

Johnson wrote in this article that both she and Not Dead Yet agree that they “should not legitimate Singer’s views by giving them a forum” (Johnson). I find this to be a very troubling thought. I understand what Johnson is trying to say, that both she and her organization don’t want to “make disabled lives subject to debate” (Johnson), but I still find fault with this view. If those with one opinion on a subject refuse to take part in discussion then how will we ever more forward in our knowledge and understanding? If those with opposing views are not open to discussion then they are doing themselves a disservice. Only through constantly being challenged will someone find holes in their argument and discover ways to strengthen and support what they stand for.

What struck me the most, though, in this article was the distinction Johnson makes between a person and his or her views. When Johnson initially meets Singer she is tempted to not shake his hand and thinks of him as “the Evil One” (Johnson); however, she later realizes that the views he holds, though different from hers, do not make him a bad person. Though she disagrees with Singer and many others, Johnson knows that she “can’t refuse the monster-majority basic respect and human sympathy” (Johnson). Johnson separates her feelings for the person from her feelings for his or her views, a separation which I think is necessary in order to continue ethical debates that will raise awareness of issues and help people consider all points of view.

Society vs. The Disabled: The Case of Patient Ashley X

According to Andy Rickell, chairman of SCOPE (a disability organization that supports people with cerebral palsy), “Society should adapt to accommodate disabled children, rather than modify them to fit into society.” But what if the modification is “in the best interests” of the patient? And if modification is justified, when is it too much modification? These are the questions being grappled by physicians and ethicists in regards to the case of patient Ashley X.

Ashley X presented with feeding problems shortly after birth, and was later diagnosed with brain damage. The brain damage “left her in an infant state, unable to sit up, hold a toy or talk.” In 2004, Ashley’s parents asked Dr. Daniel F. Gunther to perform a hysterectomy on Ashley, as well as remove breast tissue and initiate hormone treatments to stunt her growth. The operation sparked controversy in the medical field due to the ethical debate, as well as the fact that the operation had not been reviewed by a court. According to Ashley’s parents, they wanted to have the operation done to free Ashley from menstrual cramps, and also to keep her in a more manageable and portable size that would allow them to continue caring for her at home. So was the operation carried out for Ashley’s “best interests?” Or was it for her parents’ convenience?

Although I generally disagree with modifying children so that they “fit into society,” I believe this is one of the cases in which physical modification is justified. Through the operation, Ashley would have been free of personal discomfort from menstrual cramps, and additionally would have had the care of her family. Even if the operation was performed mainly for the parents’ convenience, Ashley would have ultimately benefited, because she would have been assured adequate care from her family members, whereas if she became too large to care for at home, she may have been admitted to an external care facility where she may or may not have received the same level of care she did at home.

Even though this case is justified, it opens a torrent of additional questions, and affects the care of all disabled children. With the occurrence of Ashley X’s operation, already other parents of disabled children have come forth and asked for procedures on their children. For example, Alison Thorpe from Billericay, Essex recently applied to have a hysterectomy on her 15-year old disabled daughter Katie. Additionally, physicians who carry out the operations are being criticized for doing what they had believed to be “in the best interests” of the patient. Shortly after the controversial debate regarding Ashley X’s case, Dr. Gunther, the surgeon that performed the operation on Ashley, committed suicide. Although Dr. Gunther’s motives for suicide are not clear, one cannot help but wonder how large a role the criticism of his actions as a physician played in his decision to take his own life.

As discussed in class, happiness is relative. However, benefits are a slightly more objective measurement of the justification of operations such as the one Ashley X underwent. In Ashley’s case I believe Dr. Gunther acted on the correct decision—a choice that helped not only Ashley but her parents as well. But when exploring physical modifications, one has to stop and ask, where is the line drawn between modification for convenience and modification for benefit?

Articles:
http://www.msnbc.msn.com/id/21225569/
http://www.guardian.co.uk/news/2007/oct/08/medicineandhealth.uknews

The Contradiction of Beliefs

During discussions about euthanasia, I have more often than not encountered the position that it is okay to end the life of those in a vegetative state. The reason provided usually falls along the lines of, “There is not a chance that they will recover. They will remain in the state forever, so it is reasonable to end their life because they are essentially dead anyway.” There are usually multiple justifications for this statement. One is that it is inconvenient and impractical to allow the life of the vegetative patient to continue when there is no end in sight, and when the resources could be used for other things. Another is that it would be doing them a favor since it would be suffering to live out the rest of their years in such a state. Regardless of the validity of these arguments, they all boil down to the same thing: the decision to sustain life is based upon whether or not one will eventually be able to function biologically in the future.
Without making any sort of comment on whether I agree with this or not, I would like to note that many in favor of this position also happen to be pro-choice in the debate about abortion. However, this seems to be a contradiction. If the decision does indeed depend upon the predicted ability to function biologically, then it would be reasonable to assume that abortion should be made illegal since the fetus has the potential to grow into a fully capable being. Interestingly enough, this is not at all the case – rather, the idea that the fetus is not yet human seems to be the argument of the pro-choice advocates, and that since it is not yet human, killing it is morally justified. This appears to be quite a paradox. Fetuses, though most have a solid chance to develop into a fully functional being biologically if left alone, are okay to be terminated on the grounds that they are not yet human. And yet fully-grown people in a vegetative state, though obviously human, are okay to kill as well due to the fact that they will no longer enjoy full biological-capacity.
Though this paradox does not apply to everyone generally in favor of euthanasia and/or abortion, it is certainly a strange inconsistency that I have yet to hear an explanation for.

Where do the bodies come from?

http://blog.bioethics.net/2008/02/where-exactly-are-the-corpses-for-the-bodies-exhib/

Apparently there is an exhibit in New York City about "Bodies." However, the company who is sponsoring this exhibit does not really know where these bodies come from; they only know that they come from China. The problem is that the company may be using the bodies from executed prisoners, without their consent. Obviously, the company claims that the bodies were all "unclaimed" and not those of executed prisoners.

The article ends by asking: "Why the outrage against using executed prisoners? It's not like the exhibit has a stack of consent forms for its bodies...So, are we really concerned about the the prisoners and their lack of consent? Or are we just motivated by our own unease about the act of execution?"

This same scenario is analagous to the organ donor situation. In order to be an organ donor after you die, you must give your approval during your lifetime. If you do not consent to being an organ donor while you are alive, your body will not be donated and your organs will not be removed and given to others in need.

The fact of the matter is that we are not uneasy about using a dead person's organs if they gave consent during the course of their lifetime. However, we are uneasy about using a person's organs if they never gave consent. For this reason, I disagree with the author of the article's implication that we are only uneasy about using the bodies of executed prisoners because they had been executed. I think it is unethical to use the bodies of any person who never gave permission while alive.

The reason people become more uneasy about using the bodies of executed prisoners is because it is a grisly thought to first kill someone and then harvest their organs or in this case, put their body on display for all to see. It seems like something people would do in the middle ages, not here in the civilized 21st century.

This case is not unethical because the company is using executed prisoners' bodies. It is unethical because they have not obtained consent for the use of any of their display items.

Mitochondrial myopathies: clinical trials should be allowed.

Source:

http://www.telegraph.co.uk/earth/main.jhtml?view=DETAILS&grid=A1YourView&xml=/earth/2008/02/05/sciparent105.xml

Mitochondrial myopathies are a class of genetic inheritable diseases that give rise to abnormal genes in mitochondria. In England, approximately one in every 6,500 persons suffers from this disease which translates to hundreds of affected families. Recently, a team of British researchers at the University of Newcastle has developed a way to produce genetically-altered embryos in order to prevent the inheritance of mitochondrial myopathies. So far, they have been able to: 1) produce mice embryos that do not inherit the mitochondrial myopathies from the parents, and 2) genetically alter infected embryos left over from fertility treatment to have normal mitochondria. Unfortunately, the research has been limited by the Human Fertilisation and Embryology Authority to experiments involving human cells and mice embryos. However, the Newcastle team contends that if clinical trials on human subjects were allowed, within three years, it could produce babies of the suffering families with genetic alterations such that the abnormal parts of the mother’s DNA can be replaced by another woman’s DNA.

Such medical innovation brought inevitably brought several ethical concerns. First concern involved the similarity between reproductive cloning methods and the Newcastle method. However, the 37 genes that are mutated in the Newcastle method are not in the nucleus with the DNA that encodes for physical traits; these New Castle method’s genes are within in the mitochondria organelle separated by several layers of membrane. Therefore, altering mitochondrial DNA does not have any affect on physical appearances and characteristics – something that is feared by many genetic therapy opponents to be racial and discriminatory. Another concern is the slippery slope argument: could the concession on clinical trials for Newcastle method eventually lead to concession on clinical trials for reproductive cloning? Although there is no guarantee that such scenario cannot occur, I believe that such concerns are too cautionary and not grounded on any evidence or justification. On the other hand, just as any parent has a right to seek the best medical help for their children, parents with mitochondrial myopathy ought to be able to pursue ways to prevent their children from inheriting the disease. The government cannot prevent parents from saving their children simply based on tentative claims about what might happen

For Sale: One (1) Human Kidney. $4000 or highest offer.

Currently, there are an estimated 1 million people worldwide with end-stage renal disease. Without a kidney transplant, these patients will die in a matter of months to years. By far, the largest source of transplanted kidneys is from relatives or loved ones – after all, one is able to live with only one kidney. In some instances, there are those who donate kidneys to complete strangers out of pure altruism. On the other end of the spectrum are the patients who sell their organs illegally or are forced to "donate" their organs. However, these combined only add up to 66,000 kidney transplants annually -- well below the 1 million desperately waiting for transplants.

Could establishing a legal global market for organ sales be an answer to this dilemma? The ethical issues of this immediately stand out – the poor would be pressured into donating their kidneys for financial compensation. In addition, instances where people are kidnapped and stripped of their organs could increase. However, if those extra kidneys would save the lives of those with kidney failure, would that justify such a market? Even if the idea sounds repugnant, it would benefit both the donor and the recipient.

When considering the ethical ramifications of such a market, one has to consider the fact that such a market already exists for kidneys – an illegal black market. In third world countries around the world, the poor already sell their organs for money and organized crime already strips victims of their organs for sale. With this organ market, even the poorest person in the Philippines or India has “a couple of gemstones – diamonds – on each hip”¹. The price of kidneys ranges from $1,000 in Iraq to as high as $68,000 in Bosnia-Herzegovina². This leads desperate kidney searchers to resort to what is called “transplant tourism” – where patients travel to another country (usually a 3^rd world country) in search for cheaper, more freely available medical treatment.

Relative to the current market system, a legal global market for organs could attempt to more strictly monitor and oversee the transplant process, as opposed to black market transactions which are often unsanitary and lead to infection or death. In my opinion, this fact makes such a global market justifiable. In a sense, this argument is analogous to legalizing prostitution – one could argue that if the government cannot control it, the least they can do is oversee and regulate it.

¹ Ethicists, philosophers discuss selling of human organs. http://www.news.harvard.edu/gazette/2008/02.14/01-organs.html

²Transplant Tourism. http://emeritus.blogspot.com/2006/11/transplant-tourism.html

Celebrity Endorsements... of Prescription Drugs?

I’m sure that many of you have seen the ad for the prescription cholesterol drug Lipitor, produced by Pfizer. In the ad, Dr. Robert Jarvik, the inventor of the Jarvik artificial heart endorses the use of Liptor to help lower your cholesterol when “diet and exercise aren’t enough.” Interspersed with close-ups of Jarvik pontificating on how great Liptor is, Jarvik is shown gliding gracefully over the placid surface of a beautiful mountain lake. But wait, that isn’t actually him. The rower is actually a body double, who is a member of the Lake Washington Rowing Club in Seattle. If you thought that Jarvik’s deception ended there, you were wrong. Although Jarvik has a medical degree, he is not actually a cardiologist and he is not even licensed to practice medicine. Instead, he says that 4 out of 5 doctors would recommend Lipitor to one of their family members.

The commercial itself is quite visually pleasing to watch. Therein lies the problem with the ad. Advertisements for prescription drugs should not be directed at consumers. Instead, the target audience of the commercials should be the same target group that is supposed to benefit from drugs like Lipitor. There has been considerable debate over Dr. Jarvik’s ad, but this is not the first time that consumer advertising of prescription drugs has endured close scrutiny. In 2004, “Merck withdrew Vioxx, a heavily advertised painkiller, after a clinical trial showed that it sharply increased the risk of heart attacks and strokes”. Now pharmaceutical companies are required to stagger the start of advertising for new drugs and their release onto the market.

Pharmaceutical companies, much like doctors, have a fiduciary relationship with all of their customers, who trust them to provide them with safe drugs that will help them with any of a variety of ailments that afflict the US public today. However, consumer advertising of prescription drugs is a violation of this fiduciary relationship, because the commercial appeal of the ads reveals the companies’ primary goal as one of making money, not of helping people with medical conditions.

To be fair, there are celebrity drug endorsers who are completely sincere and honest. I am speaking, of course, of Sally Fields, whose advertisements for the osteoporosis drug Boniva are motivated by her personal health condition (she is an osteoporosis sufferer), which she announced publicly in 2005. Ms. Fields has become an avid supporter of women’s health issues. However, Ms. Fields’ altruism is certainly an example that Dr. Jarvik (and Pfizer) might consider following.

Sources:
Drug Ads Raise Questions for Heart Pioneer
February 7, 2008
ntyimes.com

Baby Boom Icon Sally Fields Takes on New Leading Role as Women’s Health Advocate
April 20, 2006
http://www.rocheusa.com/newsroom/current/2006/pr2006042002.html

Embryos Created From Three Parents

Roger Highfield, a science editor for telegraph.co.uk, reported on February 5th that ten embryos have been created as combinations of DNA from one man and two women. This development is intended “to combine IVF with cell surgery to wipe out diseases caused by the equivalent of faulty "batteries" in cells, called mitochondria, that affect one person in every 6,500 with a constellation of conditions, from fatal liver failure, stroke-like episodes, blindness, mental retardation with intractable epilepsy, muscle weakness, diabetes and deafness”(Highfield). I believe that the ability for scientists to modify humans so as to prevent these diseases is a positive advancement and should be allowed in most circumstances if it will not alter the personality or inherent characteristics of the child and will make their life noticeably easier.
However, this fantastic development brings up some of the questions that Adam posed: when is it acceptable to genetically modify children?
To begin, I believe that his contention that the definition of disease, in some societies, could be extended to women because they are socially less worthwhile than men is inaccurate because it assumes that a social convention can determine a disorder, while a disease is something that is structurally wrong with a person’s biological make-up, something that would be different if the cells had all formed and developed correctly. I believe that people should only be genetically altered when they are afflicted by a disease, not when they have a different skin color, hair color, IQ, etc.
Some may believe that we should never modify people genetically, or only modify for the most severe diseases, but I believe that most modifications to remedy diseases are worthwhile because they do not change the inherent characteristics of the individual and they retain that individual’s autonomy. They also preserve the positive genetic diversity in our species, which helps prevent other diseases and make the species more resilient.
Even if the result of modification is positive, the means, in this case are potentially questionable. Who should be the parent(s) of genetically modified children? Should test tube babies have the right to know some or all of their parents, or do they have any right to be carried to term? Even if the children who are genetically constructed are never carried to term in the status quo, I believe that they eventually will be, if only for the purposes of fully investigating the implications of genetically altering them. In new discoveries, we must address both the ends and means of achieving genetic modification so as to determine if it’s ethical.

The Lining of Genes

With the advent of genetic engineering quickly approaching, mankind will soon be confronted with the issue where to draw the line between playing God and treating conditions. Someday scientists will be able to modify genes to the point where parents could essentially customize their children. Should parents be allowed to dictate the characteristics of their child? Is it ethical to allow parents to assign the sex of their child? There are two sides to the use of genetic engineering: one side advocates using genetic engineering to its fullest potential to improve the human race while the other side advocates moderate to no genetic engineering to avoid the potential ethical turmoil.

The largest issue stemming from genetic engineering is where to draw the line. Many argue that genetic engineering and gene scanning should be used to prevent diseases. But how should we define these terms? Most people would argue that a disease represents a chronic departure from the norm that leaves the individual less fit when compared to the rest of the population. When most people think of a disease they think of Alzheimer’s, Parkinson’s, AIDS, cancer, etc. because these are debilitating (usually terminal) ailments that will haunt an individual for the rest of his life. If we take disease to mean a disorder that negatively affects a person’s life, could we not also view the female gender as being a disease in China? It is common knowledge that Chinese laws allow families to bear only one child, and because families prefer males over females, many female babies have been essentially murdered. Would it be ethical to allow parents in China to choose the sex of their child to terminate this atrocious behavior?

If choosing the gender of a child is deemed ethical, where should the next line be drawn? Should parents be able to choose the height of the child? IQ? Hair color? Eye color? Where does it stop? Should parents be able to completely customize their child to have him/her be their ideal image?

I believe that genetic engineering will be a very important aspect of our lives in the near future. I believe, however, that there need to be tight regulations that dictate what genes can be altered. Part of humanity is being different and having individuality. If genetic engineering were to be used to optimize each and every person, differences would disappear as all people become smart, athletic, attractive, etc. Mankind would slowly be stripped of one of its identifying factors. Unfortunately, at an individual level, using genetic engineering to enhance one’s child proves beneficial. This situation gives rise to one similar to game theory where an individual’s desires are at ends with the desires of the population; parents would want their children to be the best possible but the population would not want mankind to be stripped of humanity. Although I believe genetic engineering should only be used to correct diseases, I realize that in the long run there may be additional problems. For example, once all diseases as we know them today become eradicated, and assuming new diseases do not develop due to superior medicine, vaccines, gene therapy, etc., how will we define the next disease? Would having light skin be considered a disease since it is more susceptible to skin damage? What about fair colored eyes that are more susceptible to light?

Where would the next line be drawn?

Last year, a woman died in a phase I gene therapy trial. Her death, unlike that of Jesse Gelsinger, may not be related to the clinical trial she was participating in. The direct cause of her death was fungal infection, which can be caused by an arthritis medication she was also taking. Of course, the study was immediately halted when the woman died, but late in November, the FDA gave their go-ahead to resume the trial. The researchers, as well as others not directly involved with the case, all agree that it is appropriate to recommence the work. However, the victim’s husband disagrees. He insists that it is still not sure whether the trial had no part in her death.

To me, it is clear that a majority of the evidence supports the continuation of the trial. However, we must ask ourselves whether a majority is sufficient. I am not sure as to the details of the investigation, but I do know that the death and the FDA’s decision were separated by only four months. If, as the researchers claim, there has been a full investigation, it is certainly acceptable to continue the study. However, if the husband is correct, and the investigation was incomplete, the researchers have an ethical duty to fully understand the death. As the Belmont report states, they are obliged to minimize the risks of the study, and an unexplained death certainly presents huge potential risk.

I am inclined to believe the researchers in this case, particularly because they are backed by the FDA and independent scientists. However, there are indications of negligence. Despite the apparent responsibility shown in this study, I wonder how a fungal infection killed someone if there was proper care provided to the patients. In particular, this woman should have been carefully watched for such infections, because of her other medications. It is the responsibility of the researchers to go beyond regular care when performing clinical trials. Not only is it important for the research, but it may also save lives.

Sources: http://query.nytimes.com/gst/fullpage.html?res=9C0CE6D81E39F935A15752C1A9619C8B63&scp=1&sq=gene+therapy&st=nyt
and http://www.iht.com/articles/ap/2007/09/16/america/NA-FEA-MED-US-Gene-Therapy-Timeline.php

Nuclear War Guinea Pigs?

Let me set the stage: it was 1956 in Britain and, like most of Europe, mass hysteria had already set in imagining the possibility of the Soviet Union possessing nuclear weapons. Of course, this type of fear often leads to irrational thinking, which certainly can be said of the following “experiment.”

A group of British sailors set out towards Australia on a somewhat vague mission; they were told that they would witness atomic bomb explosions. Now notice the word “witness”—they were to be observing from afar. Little did they know what the British navy had in store for them. Upon arriving, the sailors had little time to “observe.” The ships were told to sail through the cloud that remained following the atomic bomb explosion. Possibly for the sake of humor, the sailors were offered sunglasses to wear for this journey through the radioactive material. Not surprisingly, numerous deleterious health effects were incurred including hair loss and in some cases, death. Almost half of the men who survived developed cancer in their later years.

As one man stated, “We were used as guinea pigs. No one sought our permission to use us in an experiment and we did not volunteer.” However, it is now known that the sailors were informed of the fact that they would not just be “observing” but sailing through the remains of nuclear explosions once they arrived in Australia. Recently, a lawsuit was filed to represent 700 veterans who were apart of this experiment and others which were similarly conducted. The Ministry of Defense refuses to take responsibility. They claim that one cannot definitely link the illnesses with the exposure (a genetic component, perhaps?). One can also say that the sailors were not officially coerced into agreeing to stay after being informed of sailing through the clouds and that consent forms were not required during those years. However, obviously, one cannot deny the correlation between the number of sailors who went on these trips and the number of them who developed cancer. Also undeniable is the researched fact that “veterans who witnessed nuclear tests were three times more likely to have damaged chromosomes.” So I ask, what stand should one take when viewing this from an ethical perspective? Does ex-post facto come into play—applying laws/guidelines which exist today to a situation when these rules did not exist? Meaning, was it wrong for the navy to not ask for consent if it was not legally required at that time? On the other hand, if one does side with the sailors, what form of compensation is appropriate in light of the fact that “the damage has already been done?”

References:
http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2008/01/06/nbomb106.xml&page=1

Theoretical Ethics in Practical Settings

This blog is based on the article, “Hero or Victim? The 25th Anniversary of Barney Clark’s Artificial Heart.” (http://hnn.us/articles/44902.html).

On the evening of December 1, 1982, retired dentist Barney Clark became the first recipient of a permanent artificial heart. In late 1982, Clark had developed end-stage heart failure, and had reached the point at which he “could barely walk to the bathroom.” Clark’s decision to proceed with the heart transplant was criticized by bioethicists, and his choice is representative of the many instances in which the weight of personal rights is compared to the logic of ethics.
In the procedure, performed by Dr. William C. DeVries, Clark’s heart would be removed, and replaced with “an aluminum and polyurethane device connected to a 400-pound air compressor that would accompany Clark for the rest of his life.” After the procedure, Clark was alert and responsive—eliciting interest and admiration from observers around the world. However, during the 112 days before his eventual death, Clark experienced complications including seizures and a broken heart valve. Although he experienced confusion and even thoughts of suicidality, Clark also experienced positive days, such as when he celebrated his 39th anniversary with his wife and children.
Clark’s decision was opposed and criticized by several groups of ethicists, and rightly so. The procedure was still in the animal testing phase, and had not shown any conclusive results that would have justified the procedure. Additionally, the consent form for the procedure was characterized by George J. Annas of Boston University as “incomplete, internally inconsistent, and confusing.” With regards to Clark’s specific case, the risks outweighed the benefits, consent was ambiguous, and Clark experienced undue pain and discomfort in his final days. So why was the decision of Barney Clark, a decision criticized by ethicists from all over the country, hailed as a valiant sacrifice on behalf of science and future patients?
Despite objections from ethicists, Clark ultimately had the right to decide to sacrifice his body for the sake of science. While his decision did not result in personal benefit or benefit for society, it also did not pose any danger or threat. If that is the case, where is the line drawn between personal ownership of one’s body, and the obligation to adhere to basic ethical principals? Furthermore, at what point is a physician permitted to object to carrying out a patient’s wishes? Personally, I share the public’s view of Barney Clark as a patient that was willing to try an experimental procedure despite the risks. Frankly, without willing patients such as Barney Clark, we would not have succeeded in progressing as much as we have in fields such as “in vitro fertilization, stem cell research, enhancement technologies, and entry into stage I clinical trials.” Hopefully, in the continuation of scientific progress we will be able to successfully balance ethical responsibility with practical choices to maximize patient protection while preserving personal rights.

Required Testing for Terminally Ill Patients?

What if, completely hypothetically speaking, participation in clinical trials was required of all terminally ill patients? Of course there are numerous flaws in this proposition, but imagine for a moment that this was law. Would the benefit for society outweigh the burdens to the patients? The article Dying Children and Medical Research: Access to Clinical Trials as Benefit and Burden notes that in the 1960s there were very few, if any, effective treatments for children with cancer. Because of the large number of children enrolled in medical studies – the majority of children with cancer now take part in clinical trials – tremendous progress has been made in pediatric oncology. Leukemia, almost always fatal half a decade ago, now boasts a seventy-five percent survival rate. Without the testing of children, such success would never have been a reality. Though the children enrolled in each study may not have personally benefited from the procedures, the testing has clearly proved beneficial to future generations.

If terminally ill patients are going to die, would it not be worth it to have them take part in a study to benefit others in the future with their same disease? Perhaps the risks for a Phase I trial may be too great, but what about a Phase II or Phase III trial? The knowledge attained by testing a patient who will die anyway would provide insight into therapies which would benefit patients with the same disease in the future. The benefit to society would outweigh the burden to a terminally ill patient.

There are clear arguments against this proposition, namely, the autonomy of a patient and their right to consent to clinical trials; however, as shown by the drastic increase in survival rates for pediatric cancer, the benefits for future generation are great.

The Dilemma of Ethics

It is a curious phenomenon that a problem is almost guaranteed to arise in any reasoned debate concerning issues of ethics. Rarely is a consensus about the components of ethics reached in a group of individuals interested in the subject. Whether the topic of discussion is wealth redistribution, human rights, or bioethics, a debate is guaranteed to arise even amongst the members of a small group – our WRI 167 class, for example. The reason for this occurrence lies in the fact that everyone’s starting premises differ, the result being that our entire belief systems, which are founded upon these beginning premises, branch out away from each other and conclude with a difference in opinions. Take, for example, the existentialist and the objectivist. The existentialist would believe that truth is subjective, a seemingly ludicrous statement to the objectivist, who believes that truth is objective, a position equally absurd to the existentialist. Looking at some of the earliest premises made by each can reveal the rationale supporting their beliefs. The existentialist starts on the assumption that Cogito ergo sum, and thus truth is only a projection of the mind and so each individual’s “truth” are equal. The objectivist on the other hand begins by assuming that the individual lives in a world of a single standard of truth, and the differences of opinion are a result of imperfect perceptions of the same world. What tends to happen when two people like these meet, however, is that the logical conclusion of their premises are the theme of discussion instead of the premises upon which they are built. As a result, little progress is made.
As I am sure everyone is already expecting, clashes of ideas will no doubt occur in our class, particularly in one concerned with such a controversial field. But since our opinions on these ethical matters are conclusions rather than premises, we will likely end up mired in the same bog of endless debate as the existentialist and objectivist. This is not to say that debate is pointless, however. On the contrary, it has proven to be quite a prominent feature in the social structure of many societies, harking as far back as the Ancient Greeks, and almost definitely even farther. Why then do ethical issues tend to muddle the efficacy of reasoned discussion? The answer I propose is this: all too often, the theoretical ethics are placed in the middle of whirl of arguments which require the participants to hark back to their initial premises, an endeavor which requires an extensive amount of time and energy, sometimes to the point of impracticality. As interesting as discussions like those tend to be, I would suggest that instead, a focused approach to the practical application of policy in order to protect ethics might be better and more useful in a class like WRI 167. This would hopefully allow for a better flow of discussion, and therefore a purpose in continued debate.

The Small Print of Informed Consent

"We cannot just walk into patients' rooms and tell them they need surgery and give them an unintelligible form to sign," says Harlan Krumholz, a cardiologist and professor of medicine at Yale University who is working with several groups to improve the informed-consent process. This was taken from an article entitled “Consent Forms that Patients Can Understand” published on February 6^th in the Wall Street Journal (http://online.wsj.com/public/article/SB120224055435844931-Kd_AIJddvdLapwheyVvcLlQlbLQ_20080306.html?mod=tff_main_tff_top) This was great to see because after reading the article, I began to wonder how many times I have signed a long article with small print without reading it?

This issue of obtaining informed consent via signature but without the patient receiving any real knowledge reminds me of the fiduciary duty of doctors to patients that we read about in Dying Children and Medical Research: Access to Clinical Trials as Benefit and Burden. I got to thinking about why, especially in the fiduciary relationship of doctor to patient, there would be so much small print. Is it not part of the fiduciary duty to keep the patient fully informed? I think it should be. The main purpose of all the small print in consent forms is to protect against lawsuits and angry patients. However, if patients were fully informed via simpler educational methods, many of the lawsuits could be avoided and the doctors would actually be better protecting themselves. I thought it was great to see in the Wall Street Journal article that some hospitals have reverted to simple electronic means of educating patients about operations. Hopefully more of this can be implemented throughout the world of medical practice so that I don’t have to worry about giving away my signature.

First Class, First Essay, Current Headline

It's the Friday before our first class and the topic of our first essay assignment is back in the news. Jesse Gelsinger died in a Phase I gene therapy trial in 1999 and his case is the focus of our first unit. The January 2008 edition of the journal Human Gene Therapy includes an editorial and several commentaries of interest to us. The blog sponsored by The American Journal of Bioethics has several posts on these, including one by the Gelsinger family lawyer and another by Jesse's father.

You can find all the journal articles at http://www.liebertonline.com/toc/hum/19/1

and the blog posts at

http://blog.bioethics.net/2008/01/on-gene-therapy-and-informed-consent/

and

http://blog.bioethics.net/2008/01/on-gene-therapy-and-informed-consent/