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Bioethikos: Bringing Life to Bioethics

Archive for the ‘Research ethics’ Category

 

Editing Humanity: The Ships are Burning

Tuesday, August 1st, 2017 by Dr. Dennis Sullivan

In 1519, Captain Hernán Cortés and his Spanish conquistadors conquered the Aztecs and claimed Mexico for Spain. Legend reports that he ordered all the ships burned, so that his men would have to conquer or die trying. In reality, he merely scuttled the ships, making them unusable, but “burning the ships” has become a vivid metaphor to express total commitment to a cause.

Just two years ago last May, Chinese researchers reported the first use of a novel new gene editing technology, called CRISPR, on human embryos. The scientific and ethical world reacted with horror and dismay. “Germline engineering” of human beings, with genetic changes that could be passed on to future generations, has always been morally off-limits.

An international conference in December, 2016 proposed a worldwide moratorium on the use of CRISPR in human embryos. Yet within months, gene editing experiments began in the U.K. without much comment or apology. And just last week, similar experiments began at Oregon Health and Science University.

Here are a few of the many reasons why this is an ethically worrisome trend:

1. Experimenting on human embryos violates the sanctity of human life, period.
2. There is a ban in the U.S. on implanting CRISPR-edited embryos, but the temptation to implant and gestate them will be irresistible. This will first be done in other countries, debated and “cautiously” permitted here, and then the floodgates will open.
3. The goal is the cure of genetic diseases, but the results are completely unpredictable with our present level of knowledge. Germline therapies alter the entire genome of an afflicted individual, including reproductive cells. These changes will affect not only that person, but all subsequent generations.
4. All this won’t stop with the cure of diseases, as the new technology will quickly give rise to attempts at true enhancement: the altering (for better or worse) of human nature itself, possibly violating the image of God within each of us.
5. Informed consent, of course, is a major concern, since there is no way to get consent from future generations for the risks they will incur.

 

Yet despite the many risks, it seems that our scientists are willing, if not recklessly eager, to explore this new frontier. Like Cortés, their commitment is total, not to be distracted by bothersome ethical considerations.

And the ships are burning.

The Plot Thickens: Newest PP Video is Revealing

Tuesday, July 21st, 2015 by Dr. Dennis Sullivan

Month 7

The Center for Medical Progress has released its second video in a three-year investigative series into the actions of Planned Parenthood (PPFA) and the marketing of fetal body parts. Secretly recorded last February, two supposed research company purchasers talk with Dr. Mary Gatter, a senior PPFA official (CMP Video).

The conversation centers mostly around pricing, and how to modify the abortion technique to produce intact organs. This is very disturbing, and confirms that the first video (featuring Dr. Deborah Nucatolo) was no fluke. This apparently is “business as usual,” with the emphasis on business.

Why this is all so upsetting:

  • The description of second and third trimester abortions is graphic, and shows abortion for what it really is: legally sanctioned dismemberment of human beings.
  • The only issue for Dr. Gatter seems to be what kind of suction to utilize to better preserve intact organs. This is a medical conflict of interest: it’s not about women’s health, but about profiting from the sale of the body parts.
  • Through it all, Dr. Gatter haggles for the best price, even joking about buying a new Lamborghini (expensive sports car). She says, “Patients don’t care what we do, of course.” This just shows the cynical and callous true nature of PPFA (see my earlier blog about the “ugly underbelly” of abortion).

No, Planned Parenthood is not “pro-women,” as they claim. It is pro-business, and anti-life.

CMP Video

Center for Medical Progress

Cold Buckets and Wet Blankets

Friday, September 5th, 2014 by Dr. Dennis Sullivan

As many of you know, the ALS “Ice Bucket Challenge” has gone viral. Folks all over the world are dumping ice water on their heads to raise awareness and money to fight Amyotropic Lateral Sclerosis (ALS). This is a neurodegenerative disease of unknown cause that leads to progressive muscle paralysis. The bucket-dumpers are donating money (or avoiding it), and posting their videos on YouTube and challenging others to do the same.

And it’s working – the Ice Bucket Challenge is fun, millions have participated, and it has greatly raised awareness of the disease. More importantly, the ALS Association has seen a huge uptick in donations, resulting in more than 40 million dollars in new funding.

Hmm, but there are a few caveats. Some people are just shooting a video to get noticed, and have no intention of giving any money. As a pastor friend of mine recently blogged, “if you say you are ‘raising awareness’ of ALS and not giving money to fight it, you are just starring in your own video.” Of greater concern is the fact that ALSA helps to fund at least one research project that destroys human embryos for their stem cells in the search to find a cure. And destroying human embryos destroys human lives made in God’s image. It is the moral equivalent of murder, and our money should not support it.

Yes, but that just adds another dimension to the problem. It seems to me that a lot of pro-life Christians are going to see this as a convenient excuse to do nothing. They may hypocritically choose to keep their wallets closed, all the time sanctimoniously claiming they are defending human life.

So here is my own Ice Bucket Challenge: I am giving $100.00 to the ALS Association, but I will specify that my money not be used for research that destroys human embryos. And I would love for you to do the same: Get involved and give sacrificially to the research cause of your choice. The American Heart Association could use your help, or perhaps the Parkinson Foundation, or the American Diabetes Association. When you do, specify that your donation not be used for immoral research that destroys human embryos.

All of us are suffering under the effects of the fall of Adam. That’s why we all need a Savior. So let’s show our Christian compassion for one another, and defend the sanctity of life at the same time. That seems like a “win-win” situation to me.

Please watch the video – and see whom I call on to join me in the challenge!

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Proposed Ban on Human Cloning and Animal-Human Hybrids

Thursday, November 7th, 2013 by Dr. Dennis Sullivan

State Representative Andy Thompson of 95th District in Ohio has just introduced H.B. 308, a ban on the practice of human cloning and on the laboratory creation of animal-human hybrids. This will actually be the third recent attempt to pass such legislation, with two previous tries held up in various committees.

Why should we have such a bill? Aren’t the ideas of human cloning and animal-human hybrids simply in the realm of science fiction? Unfortunately, this is very real. For example, a team of scientists from Oregon has recently reported success in the creation of human clones, for the purpose of providing stem-cell lines for research (see “Cloning Report” below). Even more disturbing, the Human Fertilisation and Embryology Authority in the United Kingdom has (since 2008) approved the creation of hybrids and chimeras. As reported in the U.K.’s Daily Mail:

[There are] 155 ‘admixed’ embryos,containing both human and animal genetic material, . . . created since the introduction of the 2008 Human Fertilisation Embryology Act. This legalised the creation of a variety of hybrids, including an animal egg fertilised by a human sperm; ‘cybrids’, in which a human nucleus is implanted into an animal cell; and ‘chimeras’, in which human cells are mixed with animal embryos.

One research institution, Warwick University, has experimented with animal-human hybrids for the past three years. Such efforts have ceased at present due to a lack of funds, but scientists are still enthusiastic about the work. Lord David Alton of the British Parliament has said:

I argued in Parliament against the creation of human- animal hybrids as a matter of principle. None of the scientists who appeared before us could give us any justification in terms of treatment. Ethically it can never be justifiable – it discredits us as a country. It is dabbling in the grotesque.

At every stage the justification from scientists has been: if only you allow us to do this, we will find cures for every illness known to mankind. This is emotional blackmail. Of the 80 treatments and cures which have come about from stem cells, all have come from adult stem cells – not embryonic ones. On moral and ethical grounds this fails; and on scientific and medical ones too.

Lord Alton has said it well. There is no legitimate scientific rationale for human cloning or for animal-human hybrids. Leading the scientific testimony on the Ohio bill will be Dr. David Prentice of the Family Research Council (Washington, D.C.). I will also play a role to testify in favor of the ban.

ALL human life is sacred. No one should be permitted to create human embryos for the mere purpose of scientific experimentation. Whatever the perceived benefits, there are simply other more ethical ways of accomplishing these goals.

Cloning Report by Tachibana and Colleagues

Animal-Human Hybrids in the U.K.

Ohio Christian Alliance Article

 

Bizarre Episode Raises Questions About Research Ethics

Monday, August 6th, 2012 by Dr. Dennis Sullivan

Two prominent neurosurgeons at UC Davis Medical Center reportedly performed a bizarre experiment on three terminally ill patients last fall. According to an ABC News article from July 27, 2012 (cited below), Dr. J. Paul Muizelaar and Dr. Rudolph J. Schrot injected live bacteria into the head wounds of three patients. Each was suffering from glioblastoma, a malignant tumor of the supportive tissues of the brain.

The surgeons believed that infections arising from the bacteria would somehow attack the patients’ tumors, allowing them to live longer. All three patients gave their consent, though the research was performed without university authorization. Two patients died of sepsis shortly after the treatment was administered. The university has ordered the surgeons to cease and desist, and has barred them from any further human research endeavors.

In an interview with the Sacramento Bee, one of the doctors said, “We certainly didn’t blatantly trample any rules.” The surgeons insisted that the procedure was simply an unusual treatment, not actual research. The university believes otherwise. A review is underway, which could lead to problems with future research funding by the Food and Drug Administration.

A few comments:

1) There is sometimes a fine line between unusual or innovative treatments and research. A truly innovative treatment for cancer should be approved by a hospital or university Institutional Review Board (IRB). This protects vulnerable research subjects, such as the patients in this case.

2) The lack of IRB review in this case means such research may forever be tainted. What if the surgeons’ idea had actually worked? The fact that it was done without oversight casts doubt on any results, successful or not.

3) It is difficult to obtain truly informed consent from terminal cancer patients. They may be so desperate for a “cure” that they may consent to inappropriate or dangerous treatments. Think, for example, of the ongoing popularity of travel to Mexico for the treatment of various cancers with laetrile, despite its toxicity and lack of benefit.

The primary mandate of medical ethics still holds true: first of all, do no harm.

ABC News Article

 

Does Ethics Apply in a Petri Dish?

Wednesday, February 1st, 2012 by Dr. Dennis Sullivan

By Center for Bioethics Fellow Dr. Heather Kuruvilla:

Most people think of cell biologists as bench scientists who grow things in little dishes. As a university professor training future cell biologists, I wondered about my students’ perceptions of the need for an ethical framework. I asked my advanced students for their feedback on the pressing ethical issues in our field. Here are some of their ideas:

  1. The origin of the cells we work on matters.  We would find it morally problematic to help destroy embryos for stem cell research. Similarly, we would be opposed to using tissue obtained from induced abortions for research.
  2. The stewardship of creation matters.  Genetic modification of crops, as well as genetic therapies for disease, may have unintended consequences. While all of us see the potential good in producing more food or curing disease, our knowledge of outcomes is limited. We must be careful stewards of these techniques.
  3. Living creatures matter. Therefore, we should be wise in our use of resources. How drugs are tested impacts human beings as well as animals, and our use of  medications may impact the environment. We should develop research strategies that protect the environment and our fellow living creatures.
  4. The gift of human procreation matters. Not all birth control methods protect the unborn. We wish to use, study, and develop family planning technologies consistent with a high view of human persons. Genetic screening and other forms of testing may allow for informed decision making. However, we regret that some persons may use test results as a basis for abortion

Ethical standards mentioned by my students include defending human life in its earliest forms, stewardship of the world around us, valuing all of God’s creation, and thinking deeply about how we procreate. Apparently, ethics does apply in a Petri dish after all.  Aren’t you relieved?

Continued Progress with Adult Stem Cells

Monday, October 10th, 2011 by Dr. Dennis Sullivan

By Center for Bioethics Fellow Dr. Heather Kuruvilla.

A recent update reminds us that applications of adult stem cells to treat human diseases continue to progress. Cellerix is a biotechnology company that has adult stem cells in various stages of human testing. This means we may see new therapies on the market within a few years. Some of these treatments may help patients with Crohn’s disease, osteoarthritis, rheumatoid arthritis, and other inflammatory and autoimmune diseases. The cells come from adipose tissue-derived mesenchymal stem cells, are found in the adipose (fat) tissue of adults.

This news comes on the heels of a development just last month, where scientists announced they had successfully isolated colon stem cells from biopsy samples. The inability to culture certain human stem cell types from adult cell lines is one of the main arguments for using embryonic stem cells (which requires the destruction of frozen embryos). These new  developments weaken the argument that embryonic stem cell research is essential to cure certain diseases that plague humanity.

The clinical trials cited above are by no means rare.  A Google search of adult stem cell therapy brings up many therapies already in clinical use. Search [adult stem cell clinical trial] and you will find even more therapies in various stages in development. Some of sources of adult stem cells in these therapies include cells derived from bone marrow, central nervous system, and fatty tissue of adults, as well as cells derived from umbilical cord blood or cells of placental origin, obtained after birth.

For those of us who morally object to embryonic stem cell research, the fact that new and successful clinical treatments use alternative sources of stem cells is a great encouragement. As more biotech companies develop such  treatments, there will be less pressure to terminate the lives of human embryos for the sake of scientific progress.

References:

  1. Cellerix Secures 4.95M for Phase III Study of Allogeneic Adult Stem Cell Therapy: http://www.genengnews.com/gen-news-highlights/cellerix-secures-4-95m-for-phase-iii-study-of-allogeneic-adult-stem-cell-therapy/81245764/?kwrd=Adult Stem Cells
  2. Researchers Isolate and Expand Elusive Human Colon Stem Cells from Biopsy Samples: http://www.genengnews.com/gen-news-highlights/researchers-isolate-and-expand-elusive-human-colon-stem-cells-from-biopsy-samples/81245626/?kwrd=Adult Stem Cells
  3. Is the Progression of Adult Stem Cell Therapies into the Clinic a Good Sign for Technology? http://www.genengnews.com/analysis-and-insight/is-the-progression-of-adult-stem-cell-therapies-into-the-clinic-a-good-sign-for-technology/77899325/?kwrd=Adult Stem Cells

The British Cord Blood Dilemma

Tuesday, April 21st, 2009 by Dr. Dennis Sullivan

It’s ironic that the United Kingdom, one of the countries on the forefront of new biomedical research, (including embryo-destructive stem cell research), has no organized system for utilizing one of the best sources of stems cells: umbilical cord blood.

Miriam Gonzalez Durantez, the wife of Britain’s Liberal Democrat leader Nick Clegg, found this out in February when trying to donate their son’s umbilical cord blood to a national tissue bank. Only a few public hospitals in Britain are capable of collecting cord blood, and a vast array of bureaucratic and monetary hurdles prevent potential donors from being able to give.

Cord blood stem cells, taken from the discarded placenta and umbilical cord after birth, have already demonstrated enormous potential in helping patients with diseases, including cancer, leukemia, and cerebral palsy. Best of all, these stem cells are readily available, and the are no moral or ethical dilemmas associated with their use. In spite of these attractive qualities, relatively few parents in the U.S. or the U.K. know about the life-saving potential found in their baby’s discarded umbilical cord, or of the options they may have to donate the cord blood for medical research and treatment.

Miriam Gonzalez Durantez was told by officials that donation of her son’s umbilical cord blood was “impossible.” She is now trying to raise awareness of cord blood donation in Britain, urging the British government to expand the capacity of the national blood bank to collect cord blood for treatment and research.

Americans should follow Durantez’s example, and educate the U.S. public about the amazing potential of cord blood stem cells to treat human disease. As demand for umbilical cord blood grows, so will the agencies that can accept and utilize cord blood donations. Human flourishing may be improved on both sides of the Atlantic, in an ethically responsible manner.

Article in The Independent

Shifting Standards in International Research Ethics

Tuesday, January 20th, 2009 by Dr. Dennis Sullivan

The Declaration of Helsinki has long been regarded as the leading international standard on human research ethics. Drafted in 1964, the Declaration upholds basic patient rights and governs the business practices of clinical researchers. In spite of the Declaration’s widely accepted ethical authority, the U.S. Food and Drug Administration terminated its reliance on the Declaration for international research in October 2008, and instead adopted the International Conference on Harmonization’s Guideline for Good Clinical Practice (GCP).

Although GCP protocols claim common themes with the Declaration, key ethical requirements contained in the Declaration are absent from the GCP. These requirements include: post-trial access to treatment for the patient; the condition that research, especially research done in developing countries, should benefit and be responsive to the health needs of the populations of that country; that the study design be publicly disclosed; and that investigators reveal their sponsors, funding, and potential conflicts of interest to research ethics committees and study participants.

Key tenets of ethical human research include the right of the patient to informed consent, and protection of those who are vulnerable. Both of these important qualifications may be lost in GCP-guided international research. It would be impossible for a patient to truly exercise informed consent if the researchers are less than honest about the study design, sponsors, and potential conflicts of interest in the study. In addition, historic evidence demonstrates that people with fewer educational opportunities and lower socioeconomic status are often more vulnerable to pressure to join medical research. Many populations in third world countries could be vulnerable to undue pressure to participate in research studies.

Sadly, many developing countries lack the financial and healthcare resources to offer their own citizens the benefits of new treatments, even when their citizens participate in research for the treatment. A long-held concept of research ethics contends that research should be conducted only on populations that would receive benefit from the research. Populations that will receive no benefit, even due to socioeconomic reasons, do not seem to be ethically sound sources for research participants.

Good ethics has a global outlook. What we consider impermissible in U.S. research should not be accepted in international research. The Bible teaches us to love our neighbor as we love ourselves. We must stand up for our neighbors around the globe, and call for more accountability from the FDA in international medical research.

The Lancet Article

Ethics and Practicality in the Stem Cell Debate

Monday, December 15th, 2008 by Dr. Dennis Sullivan

Exciting new success stories with non-embryonic stem cells have come to light in recent weeks. Unlike embryonic stem cells, which destroy the embryo when harvested, sources of non-embryonic stem cells include bone marrow and umbilical cord blood. The list of potential sources for these non-embryonic stem cells continues to grow as research expands.

In a revolutionary treatment, doctors inserted a genetically engineered stem cell bundle into a stroke victim’s brain. The stem cells were taken from bone marrow, and the bundle was removed after 14 days. During that time, the cells repopulated the damaged area, and the victim regained the ability to speak and the use of his right arm. In a second instance, doctors transfused a child’s own stored umbilical cord blood to treat brain damage incurred at birth. Improvement in the victim’s coordination and concentration were evident just days after the treatment, and the child is now able to attend kindergarten on a regular basis.

Even if embryonic stem cell therapy posed no ethical issues for pro-life supporters, there are compelling utilitarian reasons for preferring non-embryonic stem cell research. No embryonic stem cell treatments have reached clinical trial stage in the U.S. or Europe, despite vast funding. In contrast, the potential of non-embryonic stem cells to treat medical maladies has already been demonstrated in numerous research and clinical applications.

The pro-life movement must be a strong voice to champion non-embryonic stem cell success. While not diminishing the importance of our belief that using embryonic stem cells is ethically wrong, we should also be educating the public about the ethical and practical benefits of non-embryonic stem cell therapy. In an increasingly utilitarian world, our voice might carry farther if we, too, get excited about ethically acceptable stem cell success.

Stroke Article

Brain Injury Article