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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)

Much Ado About MOLST

Tuesday, May 17th, 2016 by Dr. Dennis Sullivan

molst_form

Most healthcare professionals agree that patients rarely document their wishes about end-of-life care before a crisis occurs. This often makes decision-making difficult for both clinicians and families. I have long advocated that everyone should have an advance directive in place. This may take two forms. The first is a living will, which specifies the kind of medical treatments you want if you have a life-threatening illness and cannot make decisions for yourself. Better yet is a durable power of attorney for health care (DPAHC), which legally designates a surrogate decision-maker, typically a spouse or child, who can make decisions for you, knowing your values and acting in your best interests.

For the very sick, especially those unlikely to live more than a year, a newer document has arisen in over 20 states, called MOLST (Medical Orders for Life-Sustaining Treatment) or POLST (Physician Orders for Life-Sustaining Treatment). Unlike a ‘do-not-resuscitate’ (DNR) order, MOLST documents address more than just CPR. They may also involve the use of a ventilator, a feeding tube, dialysis, antibiotics, or simple I.V. fluids. The purpose is to carry out the specifics of the patient’s advance directives in the form of a persistent medical order. In theory, this should be a better guarantee that a patient’s final wishes are carried out.

Advantages of MOLST:

  • Can help protect dying patients from unwanted, intrusive, or disproportionate treatments (e.g., ventilators or CPR).
  • May relieve the burden of decision-making for family members and other surrogates.
  • Transferable as part of the medical record to various institutions.

Some Concerns about MOLST:

  • It is a medical document, not a legal one. It is therefore more difficult to modify or revoke it.
  • Advance directives (living wills and DPAHC) are enacted only when a patient loses decision-making capacity; a MOLST document is effective immediately. regardless of a patient’s capacity.
  • On the form, the default is to limit treatments, which may imply a utilitarian agenda that devalues life for the elderly and infirm.
  • Many pro-life groups oppose MOLST legislation, fearing that it paves the way for legalizing assisted suicide, and ultimately, euthanasia.

I have some reservations about MOLST, though the goal is to protect patients’ rights. Specifically, Ohio Right to Life is neutral on the proposed Ohio law, while other Ohio RTL groups oppose it.

ORTL Statement

Greater Cinci RTL (click on ‘Life Issues’)

Now Proven: Zika Virus Causes Microcephaly

Friday, April 15th, 2016 by Dr. Dennis Sullivan

SAMap

When I first heard about a newer mosquito-borne infection in South America, similar to Dengue fever, but with the possibility of causing birth defects, I was not too worried. I thought the news reports were overblown, and that the actual danger here in the U.S. was minimal. I was wrong. Now even the normally conservative Center for Disease Control and Prevention claims that Zika is “scarier than we initially thought.”

The Zika virus is transmitted by the Aedes aegypti mosquito, endemic in Brazil and other parts of South American, but also common in the southern United States. It should be noted that sexual interaction can also spread the virus.So far, the disease has only appeared in those patients who have visited affected areas:

With global infection rates of the Zika virus increasing rapidly, physicians should be prepared to handle possible cases of the virus and answer patients’ questions. No locally acquired vector-borne Zika virus cases have been reported in the continental United States, but cases have been confirmed in returning travelers.

 

A recent CDC report has confirmed that Zika can definitely cause microcephaly. This leads to abnormally small brains in babies born of women infected with Zika during the first trimester of pregnancy. It is not yet known what percentage of infected women’s babies actually have this problem, or what other abnormalities may appear. It is entirely possible that other problems may arise with Zika infection, or that it may even lead to miscarriages.

This is all the more worrisome because symptoms of Zika infection are often mild, and many infected subjects are asymptomatic. The CDC and World Health Organization have both issued recommendations that women in affected areas should use birth control or avoid sexual intimacy at this time.

In predominantly-Catholic South American countries, such as Peru, Brazil, Colombia, and Venezuela, abortion is illegal. But fear of Zika-infected women having babies with birth defects has led many to demand termination of their pregnancies. The Zika crisis may be used as a wedge to loosen abortion restrictions in the near future.

AMA Resource Website on Zika Virus

USA Today report on CDC advisory

Religious Liberty: Making Our Case

Tuesday, March 15th, 2016 by Dr. Dennis Sullivan

rings

The current climate of secular society has declared, aided and abetted by the U.S. Supreme Court, that traditional views of marriage are unacceptable. For those who protest, the cry of “religious liberty” has become a synonym for bigotry.

Individuals and groups that wish to uphold the view that marriage is between one man and one woman have turned to the First Amendment for help: “Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof.” Yuval Levin, in the February issue of First Things. points out that efforts to defend religious liberty could go two ways: based on the establishment clause, or based on the free exercise clause, and that efforts in the courts have depended on the latter.

Free exercise arguments work like this: religious believers should be free to act out their convictions, even when public opinion is against them. In other words, the state should carve out exemptions for such individuals. But the argument does not work very well when the individuals in question are part of larger groups, which the judiciary is loathe to exempt. And yet it is membership in such groups that should give strength to the dissenters, because the groups have a positive message to convey.

“Free exercise” arguments assert a right to not be constrained by secular public opinion. But perhaps it’s time that we made an “establishment” argument, to be free from the civil religion called progressive liberalism. And the argument should be positive rather than negative, a right to advocate for a certain view of human flourishing, rather than just to be free from constraint. Yuval Levin puts it this way:

This means we need to see that we are defending more than religious liberty: We are defending the very idea that our government exists to protect the space in which various institutions of civil society do the work that enables Americans to thrive, and we are defending the proposition that this work involves moral formation and not just liberation from constraint. That is an entire conception of the meaning of a free society that goes well beyond toleration and freedom of religion. It is ultimately about the proper shape and structure of American life.

 

There is a reason that we hold the views we do: we believe, with good cause, that heterosexual marriage as a civil institution should be preserved, and that this is the best course for our republic. Even if we are called bigots, we have a message designed to make this world a better place.

First Things article

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

Gene Editing in Animals May Become Controversial

Tuesday, December 1st, 2015 by Dr. Dennis Sullivan

salmon

(by guest blogger Kathryn Sill)
Your tall glass of milk may come from an unexpected source, thanks to DNA modification in animals. Also known as gene editing, this process uses enzymes to alter an animal’s DNA in specific advantageous ways. This may change an animal’s appearance or increase muscle mass. Such methods may be used to create better food products, to fight diseases, or even to design a household pet.

There are some major ethical concerns with all of this. Animal rights activists claim it is abusive to animals, while those concerned with food safety worry about the effects of modified DNA in the food chain. Finally, many fear that gene editing in animals will eventually lead to gene editing of human embryos.

These concerns are not far-fetched. The FDA has just approved the first genetically modified salmon for widespread consumption, soon to be available in American supermarkets. Stay tuned for a complex and perhaps divisive public debate.

Sources:
* Animal Gene Editing
* Genetically Engineered Salmon

Health Care Conscience Bill Before Congress

Monday, November 23rd, 2015 by Dr. Dennis Sullivan

health-care-md

The freedom of conscience in health care is now under attack more than ever. Nurses, doctors, and pharmacists are speaking up. From Catherina Cenzon-DeCarlo, an operating room nurse:

On May 24, 2009, the hospital where I work coerced me to assist in a 22-week abortion. My duties as a nurse included being present for the bloody dismemberment and accounting for body parts afterwards.

 

The employer threatened to fire the nurse if she did not go along with all this, despite her deeply-held religious beliefs (her beliefs had been previously identified to the hospital administration).

The modern environment in health care, based on a radical view of patient autonomy, wants to remove conscience and professionalism from medicine. If these efforts succeed, people of faith will not become healthcare providers, and the compassionate practice of medicine will erode.

S. 50, the Abortion Non-Discrimination Act, is currently before congress. It would protect any healthcare professional (doctor, nurse, physician assistant, pharmacist) or clinical entity (hospital, clinic, medical practice) from retribution or negative consequences from exercising the right to abide by their personal conscience.

Be in prayer – support your lawmakers.

Cathy’s Story (YouTube)

Freedom 2 Care Website