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Bioethikos: Bringing Life to Bioethics

Archive for the ‘Clinical ethics’ Category

 

New ‘Incentives’ to Choose Death

Wednesday, February 1st, 2017 by Dr. Dennis Sullivan

As we have commented in this blog recently, the American Medical Association (AMA) is thinking of reversing its opposition to physician-assisted suicide (PAS). Canada and five U.S. states have made this practice legal, and “aid in dying” is now a part of everyday medical discussions. Here are a few more reasons to worry about all this:

In January, the Canadian Medical Association Journal published a “Cost Analysis of Medical Assistance in Dying in Canada.” Their conclusion: patients that choose PAS could save the national healthcare system millions of dollars over more expensive palliative care. My colleague Phillip Thompson discusses this issue in his blog here.

 

More grease for this slippery slope comes from the prestigious Journal of Medical Ethics. The December issue features an article entitled, “Organ Donation after Medical Assistance in Dying” (link). PAS may become more attractive for some terminally-ill patients if they could donate their organs. So add the subtle social coercion of doing a “noble” act as another reason to choose PAS. John Holmlund reacts to the trend here.

 

Those who endorse these ideas are acting compassionately, to be sure, but with individual radical autonomy as the underlying principle, rather than an absolute commitment to the sanctity of human life. May God have mercy on all of us as we struggle to find our way in the modern context of managed health care.

Animal – Human Chimeras May Solve Transplant Organ Shortage

Thursday, June 9th, 2016 by Dr. Dennis Sullivan

pig

In a move guaranteed to raise ethical questions around the world, scientists in California are using gene-editing techniques to remove parts of a pig’s DNA, then replace it with human DNA that codes for the human pancreas. It is their hope that this will provide a source to grow human organs, toi deal with the desperate shortage of transplantable organs currently available:

Researchers at the University of California, Davis combined human stem cells and pig DNA and allowed the embryos to mature for 28 days, before terminating the experiment and analyzing the tissue. They believe the animals, if they had been carried to term, would have developed a human internal organ, but would have looked and behaved like any other pig. The goal is that in the future, similar animals could potentially act as a ready source of organs for life-saving transplants.

 

Of course, the key ethics question is: how much human DNA can be added to a pig before the pig becomes “too human?” Getting the balance right will be the goal of future research, which nonetheless promises an exciting new advance in transplantation medicine.

News Article from the Guardian

Profiteering from the Poor

Tuesday, May 24th, 2016 by Dr. Dennis Sullivan

euthan

Many of you will recall the highly publicized case last fall, of Martin Shkreli, CEO of Turing Pharmaceuticals, smirking and invoking his Fifth Amendment rights before a televised House Oversight Committee hearing. He had led his company to acquire a generic drug that had been available inexpensively for decades. The company immediately jacked up the price. As reported in Fortune Magazine:

Daraprim, a treatment for malaria and toxoplasmosis, is now 5,455% more expensive than it was only two months ago. The drug’s price jumped from $13.50 to $750 a pill, bringing the annual cost of treatment into the hundreds of thousands for some patients—and possibly out of reach for many.

 

Such unapologetic and unethical behavior by a major drug company has become common. Prices have skyrocketed on older drugs whose patents have expired, some of them on the World Health Organization’s essential medicine lists. Another good example is the antiparasitic drug albendazole, whose daily cost has jumped from about $5.92 in 2010 to $201.27 last year. One of my colleagues, who makes regular mission trips to Honduras, worries that the price increases will make the drug unavailable to the poor population he serves.

In fact, these price-gouging practices disproportionately hurt the poor.  A recent report in the New England Journal of Medicine (NEJM) put it this way:

What makes this business model particularly disturbing is that vulnerable patients — such as immigrants, refugees, and people of low socioeconomic status — are often disproportionately affected, since many of the medications are for tropical or opportunistic infections. These patients often have limited or no access to insurance, or have access only through public programs, so already stark health disparities are compounded.

 

Now I know you’ve heard the explanation for high prices usually offered by drug manufacturers: research and development (R&D) costs are high and risky. Yet here is the reality (from NEJM again):

Though some companies that have purchased and increased the price of niche medicines cite R&D as an explanation for high prices, it’s hard to find credible evidence of their involvement in substantial drug-development projects. Turing and Amedra state on their websites that they’re engaged in research, yet neither company lists substantial R&D activities or publications.

 

Let’s be clear: none of this is illegal, though it is highly unethical. The JAMA article concludes with this comment: “Timely market solutions that promote competition are needed when high prices result from monopolies.” In other words, drug companies will not do the right thing unless it aligns with their corporate self-interest. They will need a nudge from those who care about the poor.

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Fortune Magazine Article

WHO Essential Medicine Lists

NEJM Article (pdf)

American Doctor Claims Research in India was Unethical

Wednesday, February 17th, 2016 by Dr. Dennis Sullivan

caduce

An American doctor has claimed that a major study of cervical cancer in India was unethical, leading to at least 254 “pointless deaths.” American pathologist Dr Eric Suba has criticized three major long-term studies of cervical cancer, conducted in India between 1997 and 2012. In a lecture given in Mubai last February, Dr. Suba has claimed:

“In my opinion, these studies are the worst betrayals of science and ethics anywhere in the world in the 21st century.”

 

Dr. Suba may have a point. The three clinical trials in question compared an “experimental” group of low-income women screened with pelvic exams and Pap smears with a “control” group of women who had no such screening. The results were predictable: the experimental groups fared better in terms of cancer rates and survival than the controls. Dr. Suba claims, therefore, that the study was “scientifically pointless,” since it was “contemplating a question that has already been answered.”

There is an important ethical question here. The whole idea of a control and an experimental group in a statistical study depends on a principle of experimental medicine known as clinical equipoise, where we don’t really know which group will fare better. Otherwise, who would agree to take part in a randomized study? We’ve known for years that the Pap smear, invented in the 1920s, clearly detects early cervical cancer and saves lives.

The U.S Office of Human Research Protections has already found violations of informed consent in the India study, and a full investigation continues.

Suba Report Details

BMJ Discussion of Clinical Equipoise

 

New Challenges to Brain Death

Wednesday, February 10th, 2016 by Dr. Dennis Sullivan

heart-beat

Since 1969, the Harvard Criteria on Brain Death have provided guidelines for declaring a patient dead, even if the heart is still beating. This has allowed for a significant expansion of organ transplants. Donation occurs while the organ is still viable, resulting in better outcomes for recipients. As a legal, ethical determinant of the end of life, brain death is enshrined as firm doctrine in all 50 states.

Two recent cases in the news, however, have called brain death into question. In Oakland, California, 13 year-old Jahi McMath suffered a catastrophic complication of an operation to treat her sleep apnea. In Forth Worth, Texas, Marlese Munoz, 14 weeks pregnant, suffered a massive pulmonary embolism. In both cases, the patient was declared brain dead. In the case of Jahi, her parents insisted that life support be maintained, in the vain hope that she might improve and survive. With Marlese, her parents wanted to have life support discontinued, but the state intervened to keep her on the ventilator because of the pregnancy.

There are separate ethical issues in the Munoz case, but one thing should be clear: neither parents nor the state should have the power to determine when a patient has died. That is a clinical determination, and brain death is well established in ethics and law. Now, it is certainly reasonable for doctors to permit families to “say goodbye” to a loved one before turning off life support, but that does not change the facts. It is not a matter for debate: both California and Texas law permit doctors to end treatments under such circumstances, even over family objections, and protect physicians against liability for doing so.

Please note: Brain death is not an assault on the sanctity of human life. Religious voices that object to brain death often assert a sort of “Christian vitalism,” that claims physical life should trump everything, perhaps even God’s sovereignty. Modern medical ethics is complicated enough without adding this confusion.

Understanding Brain Death
Controversies about Brain Death
Arthur Caplan on Brain Death

Debate over Long Hours for Surgeons in Training

Monday, January 11th, 2016 by Dr. Dennis Sullivan

cartoon-doctor

(by guest blogger Kathryn Sill)

Most of us know that surgical trainees (residents) within hospitals can work some long shifts; 100 hour work weeks are not unusual. Recent standards by the Accreditation Council for Graduate Medical Education have attempted to reduce the number of hours to a maximum of 80 per week, in the belief that tired doctors make mistakes. But is this true?

To address the question of short versus long shifts, the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial will assess residents within 117 different training programs. This study is the first of its kind to try to uncover whether the length of shifts is detrimental to the well-being of both residents and patients. Some believe that long shifts dangerously lead to fatigue among trainees. However, those opposed to shorter shifts claim that they interfere with continuity of care and hinder communication between the residents, leading to even more errors.

The results for the study will be released in February.

Sources:
Article on surgeon training study

FIRST trial information

CRISPR–It’s not just for the refrigerator anymore!

Monday, April 27th, 2015 by Dr. Heather Kuruvilla

CRISPR_Sterics.pdf image courtesy of Wikimedia Commons

 

by Dr. Heather Kuruvilla

For most of us, “crisper” means the drawer at the bottom of the refrigerator.  But if you Google CRISPR, which stands for Clustered Regularly Interspaced Short Palindromic Repeats, you will find that it is a powerful genomic editing technology.  CRISPR can be used to inactivate  or to edit genes.  For more on how this technology works, see this article.

Obviously, any technology capable of editing genes becomes a possible target for gene therapy.  Imagine if CRISPR could be used to cure genetic disease!  This attractive possibility is why Chinese scientists recently used CRISPR to modify unviable human embryos.

The data themselves are telling.  As reported by Genetic Engineering and Biotechnology News:

It noted that out of 86 human embryos that were subjected to genetic manipulation, 71 survived. Of the surviving embryos, 54 were genetically tested. Just 28 of these 54 embryos were successfully spliced. An even smaller number turned out to contain the desired genetic material. Also, off-target effects were seen.

 

The experiment has ignited a firestorm of controversy.  Although CRISPR has shown promise in the laboratory, many scientists are wary of using this technology on human embryos when its safety and efficacy have not yet been proven.  If the study above is any indication of what would happen in a viable human embryo, there appear to be a number of troubling results.  “Off-target effects” were seen, meaning that unwanted genetic modifications were occurring.  If this is the case, using CRISPR would potentially create genetic defects that are more severe than the disease we were trying to treat.

Another problem comes with the splicing success rate.  “Just 28 of these 54 embryos were successfully spliced.”  If we were using this technology to treat embryos with genetic defects, what do we do with the embryos if our treatment fails?  Are these embryos then discarded, or  are they allowed to implant with their genetic defect still present?  I would argue that these embryos deserve our protection, as human persons created in the image of God.  However, by treating them, have we caused further damage?  In other words, are we raising the probability that these already genetically impaired embryos will not be viable?

CRISPR is an exciting new technology, and may even help us create adult stem cells for therapy.  When it comes to genetic modification of human embryos, however, this technology is definitely not ready for primetime.

Center Launches New Academic Journal

Wednesday, April 22nd, 2015 by Dr. Dennis Sullivan

BFP logo

The Center for Bioethics is launching a new peer-reviewed academic journal, entitled Bioethics in Faith and Practice. We are excited about this new venture, which will help healthcare professionals and academics with a faith perspective to articulate their values in the pluralistic arena of medical practice.

Why a new online journal, in a field already filled with academic voices? It is because of a particularly vexing problem in our public discourse, one which the late Richard John Neuhaus referred to as “The Naked Public Square.” Father Neuhaus spoke out about the aggressive exclusion of religious ideas from our national debates. This is especially true in medical ethics, where biblically-derived values are conspicuously absent. Of course, this makes no sense, because most of our patients have religious ideas that they desperately turn to in times of illness and suffering. Yet many physicians, nurses, and pharmacists are ill equipped to speak this language, and they have been taught that it is “unprofessional” to discuss these topics.

Theologian George Weigel, in discussing the Neuhaus legacy, put it this way:

[Fr. Neuhaus pointed out that] the secularism of late modernity (and, now, post-modernity) would not be neutral, civil, and tolerant, but aggressive, rude, and hegemonic. It would demand, not a civil public square in which the sources of all moral convictions would be in play in a robust debate, but a naked public square — a public square in which secularism would be de facto established as the national creed (or, perhaps better, national moral grammar). The new secularism would not be content to live and let live; it was determined to push, not only religion, but religiously informed moral argument, out of public life, and to do so on the ground that religious conviction is inherently irrational. And of course it would be but a short step from there to the claim that religious conviction is irrational bigotry . . .

 

And so we have the modern crisis of conscience rights, where the State would force doctors to perform abortions and pharmacists to dispense abortive drugs. We have angry resistance to common-sense evidence that late-term unborn babies feel pain and perhaps should be sedated before their lives are snuffed out. And we have a rising tide of states declaring it legal for doctors to discard a 2400-year Hippocratic tradition and give lethal medications to their patients to commit suicide. And if anyone invokes a Deity in protest, they are called bigoted, intolerant, and irrational.

So we need your help to bring another voice to the table. Doctors, nurses, pharmacists, healthcare students, pastors, priests, philosophers, and other scholars: please join us to bring a perspective informed by faith and Scripture back to the Public Square. Go to our website, consider our call for scholarly input, and join the discussion. From essays to opinion pieces, from book reviews to full-fledged research articles, share your insights. We guarantee thoughtful, objective editorial consideration from our world-class Editorial Advisory Board.

Yes, the Public Square is still naked, and a reasoned voice of faith is needed now more than ever.

Press Release

Call for Papers and New Journal Website

George Weigel Commentary on Neuhaus

PGD: Eugenics Is Not Dead

Monday, April 13th, 2015 by Dr. Heather Kuruvilla

EugenicsTreeLogo

by Dr. Heather Kuruvilla

There is no genetically perfect person.  Every one of us carries mutations, both genetic and epigenetic, in our genomes.  In the future, we may be able to repair these defects.  Gene therapies have shown promise in treating some types of cancer, and may eventually be used to treat or cure diseases such as sickle-cell anemia and cystic fibrosis.  But right now, genetics is being used to discriminate against, and even destroy embryonic human beings.

Preimplantation genetic diagnosis is marketed as a way to help infertile couples conceive, and is usually done in embryos which have been created by in vitro fertilization.  According to the americanpregnancy.org website,

Preimplantation genetic diagnosis involves the following steps:

  1. First, one or two cells are removed from the embryo.
  2. The cells are then evaluated to determine if the inheritance of a problematic gene is present in the embryo.
  3. Once the PGD procedure has been performed and embryos free of genetic problems have been identified, the embryo will  be placed back in the uterus, and implantation will be attempted.
  4. Any additional embryos that are free of genetic problems may be frozen for later use while embryos with the problematic gene are destroyed.

 

In the future, we may be able to use such technologies to diagnose and repair genetic defects.  But at present, this technology is only used to destroy embryos, since we don’t yet have the capability to fix them.  Is this technology simply giving hope to infertile couples?  Or has eugenics reared its ugly head yet again?

The Coming of Medical Martyrdom

Monday, March 16th, 2015 by Dr. Dennis Sullivan

caduce

Do you remember a time when folks talked about a doctor’s oath, something that dictated his or her ethics? Most don’t realize that this originally came from Hippocrates in about 400 B.C., but they assumed that healthcare was guided by professionalism and compassionate care.

Today, the New Medicine is no longer concerned with the Hippocratic Oath, and we no longer hear much about doctors as healers. Now it is all about individual choice, about radical autonomy run amok. In this modern world of consumer health care, the customer is always right.

So what about those who refuse to play along? What about those doctors, nurses, and pharmacists who refuse to cooperate with patient demands for abortion or for drugs to help them kill themselves? In more and more cases, they are censured by their professional societies, and may even be subject to lawsuits. In Belgium, in the Netherlands, in Australia, in Canada, and now increasingly in the U.S., the highest priority is placed on an individual patient’s choice, and these strictures are increasingly finding their way into our laws.

Wesley J. Smith, a moral philosopher and commentator for the Discovery Institute, puts it this way:

If these trends continue, twenty years from now, those who feel called to a career in health care will face an agonizing dilemma: either participate in acts of killing or stay out of medicine. Those who stay true to their consciences will be forced into the painful sacrifice of embracing martyrdom for their faith.

 

With such assaults on health care rights of conscience, the newest martyrs may be those who wear a white coat.

Wesley J. Smith Commentary