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Bioethics and Fetal Tissue Hearing

BY G KEVIN DONOVAN, MD, MA

On March 2, 2016, Dr. G Kevin Donovan testified at the “Bioethics and Fetal Tissue” hearing before the Select Investigative Panel of the Committee on Energy and Commerce of the US House of Representatives. Dr. Donovan was one of six witnesses to present testimony.

 

Chairman Blackburn, and members of the panel, I thank you for the opportunity to present testimony regarding the bioethical considerations in the harvesting, transfer, and use of fetal tissues and organs.

I am a physician trained in both pediatrics and clinical bioethics. I have spent my entire professional career caring for infants and children. It was this interest and concern that led me to further study in bioethics, because I have always been concerned about the most vulnerable patients, those who need others to speak up for them, both at the beginning and at the end-of-life. I also have significant familiarity with research ethics, having spent 17 years as the chair of the IRB, a board that monitors the rightness and the wrongness of medical research in order to protect human subjects. We took this aspect of our duties so seriously that I renamed our IRB the Institutional Research Ethics Board. Four years ago, I was called by my mentor, Dr. Edmund Pellegrino, to take his place as director of the Center for Clinical Bioethics at Georgetown University. Our duties include ethics education for medical students and resident physicians, ethics consultation for patients and doctors at the hospital, as well as the promulgation of scholarly papers and public speaking. We focus on both clinical ethics, that which directly involves the good of patients, as well as addressing normative questions, those which involve right and wrong actions.

This is what we want young physicians to know: medicine is a moral enterprise. Our actions have consequences that can be good or bad for patients, and we must always focus on the patient’s good and avoid doing harm. So what does this mean for the topic at hand? We’re talking about bioethics and the fetus. In order to make any moral judgments, we would have to be clear on the moral status of the fetus. Obviously, this is an area in which society has not reached a consensus, but that does not mean we cannot make sound judgments on the topic. In a question of biomedical ethics, it is good to start with solid science. What do we know about the fetus with certainty? Well, first of all we know that it is alive, that it represents growing, developing, cells, tissues, and organs, all of which develop increasing complexity and biologic sophistication, resulting in an intact organism, a human baby. Of course, this growth and development does not cease with the production of the baby, but continues for many years afterwards. As can be seen by this description, the fetus is not only alive, but is demonstrably human. I’m not talking about a “potential human” in the way that some parents talk about their teenagers as potential adults. I am referring to the scientific fact that a fetus constitutes a live human, typically 46XX or 46XY, fully and genetically human. In fact, it is the irrefutable humanness of these tissues and organs that have made them be of interest to researchers and scientists.

So, if a fetus is clearly both alive and human, can we justify taking these tissues and organs for scientific experimentation? If so, under what circumstances, and what sort of consent or authorization should be required? In the past century, medicine has made incredible progress resulting from scientific studies involving human tissues and organs, resulting in the development of medications, vaccines, and the entire field of transplantation medicine. Is there any difference between these accomplishments and those that would require the harvesting of bod parts and tissues from the fetus? First, we would have to admit that not all scientific experimentation has been praiseworthy. Studies done by Dr. Mengele in Germany, and by American researchers in Guatemala and Tuskegee, we morally abhorrent, and any knowledge gleaned from these would be severely tainted. No one would want to associate our current scientific studies involving the human fetus with such egregious breaches of research ethics. All that it takes to avoid such a comparison is a consensus on the moral status of the fetus.

Those who have proceeded with experimentation and research on embryonic and fetal cells, tissues, and organs typically have obtained them as the result of an abortion. It is this stark fact that makes such scientific endeavors controversial, because they have proceeded without the aforementioned consensus on the moral status of the fetus. Because we know that the fetus is alive, and human, we must find some explanation for why it should not be treated with the same dignity that we accord all other human lives. The most frequent argument offered is that, although it is a human life, it is not a human person. Various criteria are offered for a definition of personhood, but none have been found universally acceptable. We thus have a standoff between those who would protect this early vulnerable human life and those that would deny that it deserves protection. In order to resolve such an ethical dilemma, the guiding principle is this: one is morally permitted to take such a life once you can demonstrate with moral certainty that the life is not human. It is a concept that can be exemplified by the situation faced by a hunter when he sees a bush shaking. He may sincerely believe that it is a deer in the bush, but if he kills it prior to determining with certainty what it is that he is killing, he will be morally responsible (as well as legally) if he has in fact killed the farmer’s cow, or worse yet, the farmer. As we can see, two deeply held, but opposing viewpoints need not be resolved unless someone intends to act upon them. Then, the one who intends to take the action resulting in the death of the disputed entity must not do so unless they can first show with moral certainty that their perception of its moral worth is irrefutable. Those who would not disturb the normal progression of its life bear no such burden. It’s my contention that such proof does not exist, and deliberate fetal destruction for scientific purposes should not proceed until it does.

Moreover, without disputing the arguable necessity of research on fetal tissue, I would also point out that harvesting it n such a way is unnecessary. Not only do cell lines already exist that were produced in such a fashion, but new cell lines could be obtained from fetal tissues harvested from spontaneous miscarriages. This is not a theoretical alternative. Georgetown University has a professor who has patented a method of isolating, processing, and cryopreserving fetal cells from second trimester (16-20 week gestation) miscarriages. These have already been obtained and are stored in Georgetown freezers.

Moreover, the present practices of obtaining fetal tissues and organs would seem to go against the procedures that have been approved for others who harvest tissues and organs donated for transplantation. First, we follow a strict rule, the dead donor rule. It states that vital unpaired organs cannot be obtained unless the donor has died a natural death. This obviously is not the case in an induced abortion. Moreover, such tissues or organs cannot be harvested without consent of the patient or their proper surrogate. In pediatrics, parents are considered the normal proper surrogate. However, this interpretation rests on the presumption that the parent is acting in the best interests of the individual. It is difficult to sustain such an interpretation when it is the same parent who has just consented to the abortive destruction of the individual from whom those tissues and organs would be obtained.

We are at a difficult time in our nation’s history. We demonstrate much moral ambiguity in our approach to the human fetus. We have decided that we can legally abort the same fetus that might otherwise be a candidate for fetal surgery, even using the same indications as justification for acts that are diametrically opposed. We call it the fetus if it is to be aborted and its tissues and organs transferred to a scientific lab. We call it a baby, even at the same stage of gestation, when someone plans to keep it and bring it into their home. Language has consequences, but it can also reflect our conflicts. We are a nation justly proud of the progress and achievements of our biomedical research, but lifesaving research cannot and should not require the destruction of life for it to go forward. If we cannot act with moral certainty regarding the appropriate respect and dignity of the fetus, we cannot morally justify its destruction. Alternatives clearly exist that are less controversial, and moral arguments exist that support our natural abhorrence at the trafficking of human fetal parts. Surely we can, and surely we must, find a better way.

 


 

ABOUT THE AUTHOR

G. Kevin Donovan, MD Director G. Kevin Donovan, MD, MA

G. Kevin Donovan, MD, MA is the Director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center. He is also a professor in the Department of Pediatrics at Georgetown University School of Medicine.


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Testimony at Hearing on Maryland Physician-Assisted Suicide Bill

BY G KEVIN DONOVAN, MD, MA

Written testimony from Dr. G Kevin Donovan at a joint hearing of the House Health & Government Operations Committee and the Judiciary Committee of Maryland on February 19, 2016, regarding the proposed end-of-life bill.

 

Thank you for the opportunity to address this proposed legislation. I am Dr. Kevin Donovan, a physician, and the director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical School. Much of my work in the hospital setting involves consultation on patients who are nearing the end of their lives, so I have a real interest in this bill.

You will hear from others about the problems that have arisen in identical bills. You will hear about the dangers it can cause to patients, particularly the disabled or chronically ill, to the medical profession, and society at large. So I will not tell you about these things. I will tell you that I oppose this bill for two reasons: it is discriminatory, not progressive, but it is deceitful.

Okay, what are we talking about? Aren’t progressive people in favor of this bill? Perhaps some are, but if they look deeply into it, they shouldn’t be. Years ago, Sen. Hubert Humphrey said the real worth of any society can be found in the way that it cares for its most vulnerable members. That would be progressive, but we live in a society that increasingly worships autonomy, freedom, and productivity, and pushes those that don’t fit the picture to the margins. Therefore, it should come as no surprise that marginalized people, the poor, blacks, Latinos, and virtually every disability rights group are afraid of this bill. It creates by law a class of people whose lives no longer should be preserved. Of course, creating separate classes of people is discriminatory, but isn’t that what the supporters of this bill want? Yes, and we should look and see who are the supporters of this bill. It is favored by the same classes of people that have taken advantage of it in places like Oregon. Who’s the typical proponent, and patient? As published statistics show, the typical patient is a white male, usually with cancer, educated and financially comfortable. This is someone who is used to thinking that they are in control, and want to maintain the illusion of control near the end their lives. And make no mistake – the data from the Oregon health department makes it clear that this is not an issue of avoiding pain. The stated reasons for seeking a fatal prescription are primarily loss of autonomy, loss of ability to engage in enjoyable activities, or fear of being a burden to others. Pain is low on the list, because with good palliative care, pain is controllable. We’ve just described legislation that would favor the white elite, not the sort of thing that progressives usually want to get behind. And as one commentator asked, “Is anyone ashamed that we live in a culture where people believe that if they aren’t autonomous, or might be a burden on others, that they should ingest drugs and die?” I would think that Maryland should be ashamed of promoting assisted suicide for patients before palliative care is universally available?

Okay, if this bill is discriminatory not progressive, why should it be seen as deceitful? First of all, our antenna should always go up when people start using euphemisms. What started out as a movement for physician assisted suicide became physician assisted death, and now just wants to be thought of as death with dignity. Really? This can’t be the only path to dignity, and it clearly is suicide that we’re talking about. After all, the Center for Disease Control defines suicide as, and I quote “Death caused by self-directed injurious behavior with an intent to die.” What we’re talking about in this bill is clearly suicide, whether or not we’re allowed to put that on the death certificate, and by the way suicide is already legal. And when we talk about the protections in this bill, we’re not being entirely forthright either. The ones who are really being protected are the physicians, once again, members of the power elite. We may say we are placing restrictions for the patients involved, but that’s not entirely true, because they’re not entirely coherent. After all, once we redefine supporting or encouraging a patient’s death as a good thing, how can we defend limiting that benefit, that good thing, to only those who will be dead in six months? Why not 12 months? Why only terminal illness – why not suffering from chronic disease? Why only assisted suicide? What if the patient can’t lift the toxic mixture to their lips – shouldn’t someone else be able to give them a lethal dose? Shouldn’t we be willing to end the suffering in this way, even if you’re under 18, even if you’re only a child? Proponents will say that this is not what the bill says, nor what they intend, but this is the natural, logical, and really inevitable result of this redefinition of death as a medical treatment. In fact, this has already happened in Belgium and the Netherlands, countries that have been doing this longer than we have.

Finally, this brings us to an area which make legislators truly sit up and take notice: it is just not good public policy. Suggesting that suicide or euthanasia, are legitimate tools of the state is frightening. Throughout history, we have learned that granting the state legal authority to kill innocent individuals has had dreadful consequences. In Maryland, if you are convicted murderer and in no way innocent, you would be protected from the killing power of the state. Why would we want to turn that power to kill on our patients with their physicians help? A Dutch cardiologist, who has experience with this in his own country, recently stated, “the fundamental question about this is whether it is a libertarian movement for human freedom and the right of choice, or an aggressive drive to exterminate the weak, the old, and the different – this question can now be answered. It is both.“ I have no doubt that some patients with great independence will choose an early death at the end of their lives. They should not be judged, they should never be prosecuted for the attempt. As a society, we should be offering patients loving support until the very end. We shouldn’t change the law in a way that might encourage their deaths, we shouldn’t take their hands and lead them towards that, and certainly shouldn’t make them feel that they are being subtly pushed into it. The sick, the vulnerable, the suffering and dying deserve so much better, and a truly caring society will provide them with no less.

 

Addendum:

” On March 4, the bill SB 418 was withdrawn by its sponsor Senator Ron Young for lack of supporting votes, killing it for the legislative year.”


 

ABOUT THE AUTHOR

G. Kevin Donovan, MD Director G. Kevin Donovan, MD, MA

G. Kevin Donovan, MD, MA is the Director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center. He is also a professor in the Department of Pediatrics at Georgetown University School of Medicine.


 

 

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PAS: Unwise, Uncontrollable, and Unnecessary

BY G. KEVIN DONOVAN, MD, MA

 


 

Proponents of physician-assisted suicide point to real and tragic stories of suffering in individuals at the end of life. I’ve heard the stories and found them heartbreaking, making me and others want to do something to alleviate such situations. Unfortunately their solution would not make for a better society; they offer a cure that is worse than the disease. Their plan would be to change the laws governing suicide in every state. Currently, suicide is not illegal in any of the states or the District of Columbia. What they would change is the prohibition of assistance from an outside party, specifically in this case, a physician. This would result in a profound shift in the doctor-patient relationship, and the profession of medicine. For 2 millennia, physicians have striven to separate themselves from those who would deliberately cause harm. The Hippocratic oath, still taken in some form by most medical school graduates, states specifically “I will give no deadly medicine to anyone if asked, nor suggest such counsel.” The American Medical Association still states that participating in assisted suicide or euthanasia is incompatible with the role of the physician. Given this tradition and the importance of the doctor-patient relationship, it is unclear why proponents of PAS seek to legislate the involvement of physicians in assisting with the patient’s suicide. It is likely because of the trust relationship that exists between patients and their doctors, a trust that would be eroded in many cases by even so much as an offer from the physician to bring about their patient’s death.

Those who would like to see physician-assisted suicide (PAS) legislation passed assert that it would only be done with appropriate restrictions and protections. In fact, the only real protections are for the physicians who would involve themselves, with the law protecting them from any consequences of their involvement, short of felonious behavior. It also protects from discovery the records of the activities surrounding PAS – reports are to be sent to the Health Department, which collates them, issues an anonymized report, and destroys the originals. What is missing here is the adequate protection for patients. Although the law would initially restrict PAS to those with a terminal disease with six months to live, these restrictions, if viewed closely, can be seen to be indefensible. Changing the law to legalize PAS is based on an appeal for autonomy for the patient; it redefines medical care to include, as a medical good, aiding in the death of the patient. But if we enshrine this new medical good with the power of law, we will make it logically impossible to deny that good in multiple other cases.

Why should a patient have to be expected to die in six months, rather than 12? Why must they be terminally ill rather than suffering from chronic incurable illness? Why must they be able to take the medicine themselves -what if they are too weak, too debilitated, too demented – why can’t someone else give them a lethal dose? Why even should we restrict this new “benefit” to those over 18; we know children can suffer from terminal or chronic conditions. Shouldn’t this new medical benefit include them as well?

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When a legislature undertakes to change the law, they change the moral fabric of society as well. What was previously unthinkable is now legal, and soon becomes the norm. This places all patients at risk, not solely those whom society has disadvantaged by reason of poverty, color, or physical disability. An elderly grandmother, seen by those she loves to be suffering, may hear the suggestion of assisted suicide as something she would never have considered before now. But, now that it’s legal, it must be all right, and perhaps should be considered, not so much because it is her strong desire, but because she does not want to see her loved ones or their financial resources further exhausted.

Legislators should always be cautious when considering revolutionary changes in societal norms. They should certainly have a clear and strong understanding of the effects on the majority of the citizenry. This is particularly true in PAS when so many long-term consequences are still uncertain. It is even truer when the change in the law is designed to privilege the few at the risk of many. We are repeatedly told that only a few patients would likely seek the solution annually, and some of the data from other states suggest this may be the case, at least at first. We must ask ourselves if such a drastic change in the legal landscape for such a small number is wise or is necessary. We now know that we have long suspected: patients have already been obtaining assisted suicide from physicians willing to provide it, without any legal sanction. It appears that those who want assistance in their suicides can find it, even in places where it has not been authorized by law. It would be more difficult in all likelihood, and would give people pause before proceeding. Would this be such a bad thing, if someone had to consider that step carefully and with all due deliberation?

I do not think that assisting in suicide meets the deepest and most fundamental needs of the suffering patient. I think they need physical and emotional support, the reassurance that they are never considered a burden, and a loving presence to their very end. I know that there are those individuals who would disagree, and might want to proceed with their self-inflicted deaths whether it were legalized or not. They should not be judged, they should never be prosecuted for the attempt. As a society, we shouldn’t change the law in a way that might encourage their deaths, we should not take their hand and lead them towards that, and certainly shouldn’t make them feel they are subtly being pushed into it. But overall, the sick, the vulnerable, the suffering, and dying deserve so much better, and a truly caring society would provide them with no less.


 

ABOUT THE AUTHOR

G. Kevin Donovan, MD Director G. Kevin Donovan, MD, MA

G. Kevin Donovan, MD, MA is the Director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center. He is also a professor in the Department of Pediatrics at Georgetown University School of Medicine.

 

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Reference:

Emanuel, Fairclogh, et al. “Attitudes and Practices of US Oncologists regarding Euthanasia and Physician Assisted Suicide, Ann Intern Med2000; 133:527-532,www.annals.org.

Images: Creative Commons

Physician-Assisted Suicide and the Medical Profession

 

BY G. KEVIN DONOVAN, MD, MA

Recently, Gov. Jerry Brown of California signed into law a bill authorizing physician-assisted suicide in that state. It now joins Oregon, Washington and Vermont as the only states that voted in such legislation. The legislation initially failed to pass, but was moved through by an unusual process in a special session of the legislature. It was clearly influenced by the Brittany Maynard case, a young woman from California who moved to Oregon for assisted suicide after being diagnosed with a brain tumor. She became the poster child for a campaign by Compassion and Choices to make physician-assisted suicide legal throughout the nation. It can be considered a huge public relations success, but a legislative failure for the most part.

In the past year, similar bills were introduced in 25 states plus the District of Columbia. So far, they have failed or stalled out everywhere, but California. When Gov. Jerry Brown signed the bill, his stated reason was that he did not want himself or other Californians to die in pain, and therefore they should have the option for suicide when terminally ill. As a rationalization, it was somewhat disappointing, not least from a moral perspective from this former Jesuit seminarian. At some point he must have learned that suicide violates the Commandments, and assisting someone else to do so is even more morally problematic, because diminished capacity is less likely to be a mitigating factor for the cooperator. Even if this were not all true, it would be disappointing that the chief executive of the state had such a poor grasp of the additional issues that argue against physician assisted suicide.

There are cogent reasons to avoid legalization of PAS, without reference to moral or religious arguments. Gov. Brown’s first mistake was failing to realize that such legislation was not needed for patients to be authorized to proceed with suicide whenever they wished. Since the past century, suicide has been decriminalized in all 50 states and the District of Columbia. Therefore, the model legislation introduced by Compassion and Choices offers no new protections to patients; it merely protects doctors who write the prescriptions for them. Moreover, as we shall see, uncontrollable pain is not really an issue that would require PAS, nor is it an actual motivator for those who seek it. In fact, PAS has deleterious effects on society, the medical profession, and particularly the patients that it should serve.

As documented by the Oregon experience, patients there who seek PAS are not motivated by issues of uncontrollable pain. They are typically privileged, educated, white males, most often with cancer, fearing loss of control, lack of ability to participate in their enjoyable activities, or a risk of being burdensome. These are not purely medical problems. As Steven Miles has recently pointed out:

Entrusting this profound existential problem to the physician-patient relationship is why this is a falsely premised medicalization. Ironically, the public has chosen a technological fix that illuminates the very problem of the depersonalized medical death that it challenges. California’s law will result in medically assisted suicides, but there is little reason to believe that it will advance the humanization of persons who are dying. The literature on patient suicides suggests that physicians who are most discomfited by disability, a patient’s fears, or the burden of chronic disease, enable a decision to suicide, in a counter transference reaction. Furthermore, few modern physicians have any interest or training in how to address existential concerns – suicide being the most profound existential issue.

Those patients who may face similar situations but have no desire for Physician Assisted Suicide also experience an increased sense of vulnerability when such laws are passed. To have certain lives designated as more deserving of death (when terminally ill) can easily be extended to the lives of the elderly, physically disabled, mentally disabled, and depressed. They will see their lives as less valuable to society, their care as devalued.

Such legislation can hardly be seen as an enhancement to the medical profession. To have physicians offer a medical death rather than treatment or support for seriously ill patients will produce a corrosive effect on the doctor-patient relationship. Although this offer may be welcomed by some, it will rightly instill fear and confusion in those who depend on their physicians to fulfill the traditional (and essential) role of healer. It will also decrease the physician’s motivation to learn and employ palliative care measures. End-of-life care is expensive, challenging, and emotionally draining. However, assisting suicide for those willing to do it is simpler, quicker, and cheaper. Nevertheless, it does not always bring satisfaction even to the physicians involved, as reports from Oregon demonstrate that 24% of physicians previously involved in PAS develop depression caused by their actions and an aversion to repeating them. This is probably why in Oregon, over a seven-year period, only three doctors wrote 23% of the prescriptions for PAS and a mere 20 doctors accounted for 84% of the prescriptions statewide, meaning 99% of Oregon doctors did not participate in the practice.

Society’s inability to monitor and control PAS may be its most frightening aspect. The reported data from Oregon is suspect because, among other things, doctors are forbidden to list PAS as a cause of death on death certificates, and after an annual collection of reports, all individual data is destroyed. In European countries that have more experience with the practice, it has become clear that the touted limitations for PAS do not and cannot restrict indications for PAS or euthanasia. In Belgium and the Netherlands they now include almost any chronic illness, including anorexia nervosa, senility and dementia, deafness/blindness, severe depression and mere advanced age. Such “indication creep” is logical and inevitable once the option of induced death is legitimated as a medical good. If PAS is good for patients, then restrictions will be seen rightly as arbitrary and discriminatory, a violation of autonomy, an unjustifiable withholding of a medical good. Physician Assisted Suicide or euthanasia become the “treatment of choice” for those who don’t want to feel that they are a burden or who fear abandonment. Is this the best we as a society have to offer to the sick and vulnerable?

 

G. Kevin Donovan, MD, MA is the Director of the Pellegrino Center for Clinical Bioethics and a professor in the Department of Pediatrics at Georgetown University School of Medicine.  

 

References:

Oregon’s Death with Dignity Act – 2014: HTTP://public.health.oregon.gov/Provider Partner Resources/Evaluation Research/Death with Dignity Act/year 17.PDF

The Advance of Physician Assisted Suicide in California, October 7, 2015: info@ncbcenter.org

MCW list serve: Steven Miles, October 2015

Image: Creative Commons