Stem Cell Rx No Longer For Sale on Google

Perhaps once a week, I will be asked by a patient about the potential benefits of stem cells for reversing the normal affects of age, particularly with respect to arthritis of the knee joints, hip joints or the degenerative discs in the lumbar spine. I believe one of the reasons for this interest has come from increasing advertisements by various clinics in my region of East Tennessee claiming stem cells are the answer for these problems. My region is not unique. A simple Google search on “stem cells for knee pain” yields ads for clinics offering such treatment.

Stem cells are cells that have potential to become any type of cell in the human body such as a new blood cell, nerve cell or bone/cartilage cell. Scientists are rapidly learning how to find or create stem cells, as well as how to safely use them to replace old or missing cells, thus restoring function in worn out, damaged or diseased areas of the body. In fact, stem cells are presently used to replace the bone marrow for some individuals with certain cancers and disorders of the blood and immune system, and in many of these cases, the results are lifesaving.

The problem is that stem cell treatment remains yet unproven in all other medical conditions, including the age-related arthritis conditions which I treat. This lack of efficacy has not stopped clinics from offering and patients from receiving stem cell injections with the hope of achieving improved function or cure. I am willing to grant that many offer these treatments with the sincere hope and belief that they are acting in their patient’s best interest, though I suspect not all have the patient’s best interest in mind. Unfortunately, there have been severe adverse events. Examples include blindness following an injection of stem cells into the eye, and loss of function with development of a spinal cord tumor following stem cell injection into the spine.

The FDA is trying to educate the public and prevent stem cells from being offered for unproven treatments. The FDA has the authority in the US to stop these unproven treatments and take punitive action if needed. This is not to suggest that the FDA is in the business of preventing legitimate investigation into the potential benefits of stem cells, such as this Mayo Clinic Phase 1 study looking at the risks of injecting stem cells in to the cerebrospinal fluid of patients following a spinal cord injury to see if this particular stem cell technique causes harm (with future studies needed to determine benefit).

The FDA is recently getting some help from Google. On September 6th, Google announced it would stop accepting ads for unproven medical treatments, including stem cell therapies. It is early in the effort and the initial link above still has four ads for non-bone marrow stem cell treatments returned with the Google search. Maybe by the time you read this blog entry, the stem cell ads for unproven treatments will be gone.

I am hopeful that stem cells will eventually provide patients with safe therapies that repair injury and return patients to normal health. Offering that promise without the studies that prove such benefit is unethical and potentially harmful. It is good to see Google favoring human welfare over financial profit.

Promoting vaccination with a not-too-heavy hand

This week’s Nature has a worthwhile read, “Mandate Vaccination with Care.”    The recent rise in the number of cases of measles is well-documented in the general press, and there is a strong argument that it is a social good that sufficient numbers of children be vaccinated for a range of infectious diseases.  Your correspondent considers it unfortunate, to put it mildly, that there is a persistent belief that vaccines for the standard childhood diseases are harmful.  Although some cases of vaccine harm occur, they are rare—rarer than many in the general public believe—and the cost of under-vaccination is great.  I, for one, never want to see an infant with pertussis (whooping cough) again, and, although I recall having had measles and chicken pox when I was a kid, it’s best to prevent them.  Some can even be eradicated (see: smallpox—which we should fervently hope is never purposely re-introduced, now that we don’t routinely vaccinate for it). 

In brief, the authors in this case argue for promoting vaccination in the public with such steps as ensuring supply and access, providing information and allowing public forums, monitoring safety carefully, and tracking vaccination rates.  They argue, reasonably, that mandatory vaccination that carries the wrong kind of penalties—such as, fines or even jail sentences imposed in some countries—for non-compliance actually can harm poorer, medically underserved people, and as such be counterproductive and, frankly, unfair.  They comment that harsh mandates can unnecessarily prompt a backlash, with increased resistance.

They say, further, that if mandates are deemed “politically appropriate,” then the procedures should be just, with constraints on choice as limited as possible; any penalties must be proportionate; those who do suffer complications should be adequately compensated.   They speak favorably of creating administrative hurdles to getting exemptions from mandates.  They also argue against governments mandating only some vaccines while excluding others.  They claim that making some vaccines only “recommended” can limit the uptake of all. 

This last point may be the most questionable of all in this article.  It is easier to justify mandating vaccination for highly contagious diseases that can have devastating effect (e.g. measles, rubella, diptheria, and others), than, for example, vaccination for human papilloma virus (HPV), infection with which predisposes to certain kinds of cancer but transmission of which is through sexual activity.  In this last case, the argument for a mandate is substantially weaker; vaccination at a fairly young age might be wise, but one might still reasonably accept, for oneself or one’s child, the less certain and more remote risks of the consequences of infection, and therefore reasonably object to mandated vaccination.

Again, a worthwhile read. >

Good from Evil

I was given an article by a student of mine following his one month elective rotation with me in which we spent some clinical time discussing bioethical issues. The May 2019 web article by Sharon Begley from Statnews.com had to do with an interesting medical dilemma first presented in 2016 by Dr. Susan Mackinnon from Washington University in St. Louis. I have briefly summarized Begley’s article in the first part of today’s blog and extended her point at the end.

Dr. Mackinnon had a patient who was having severe leg pain following multiple knee surgeries. Dr Mackinnon was providing the final surgical attempt to isolate the nerve presumably being compressed by scar tissue in hopes of surgically decompressing that nerve to permanently relieve the patient’s severe pain. If the surgery was not successful, the only other option at that point was to amputate the leg. During the surgery, she used an old anatomy book called The Pernkopf Topographic Anatomy of Man, which unambiguously has the best illustrations of nerves around the knee, and successfully located and decompressed the nerve in question and successfully avoided an amputation.

So, what was the dilemma?

As Begley points out in her article, it came to light in the mid-1980s that the illustrations used in the Pernkopf atlas were based in part on the bodies of people executed by the Nazis in the late 1930s. The moral dilemma for Dr. Mackinnon was therefore:

“…even now, the Pernkopf illustrations are unsurpassed in their accuracy and detail, especially their depiction of peripheral nerves…and although a few journal papers may have an equally good, single illustrations, finding the right paper takes time that Mackinnon did not have as she stood over her patient.”

Dr. Mackinnon had been given the Pernkopf atlas as a graduation gift in 1982 but the Nazi history behind the atlas was not known until the mid-to-late 1980s, the full history of which only became known to her after the surgery. Should she continue to use an atlas that contains illustrations of the bodies of people executed by the Nazis? If used, is there a duty to inform a current patient about the nature of the atlas? Can sufficient good be derived from the atlas given the unspeakable evil required to create it to permit its ongoing use?

She posed her dilemma to Rabbi Joseph Polak, the Chief Justice of the Rabbinical Court of Massachusetts, who consulted Prof. Michael Grodin of the Elie Wiesel Center for Jewish Studies at Boston University. Their opinion became known as the Vienna Protocol, due to the origins of the Pernkopf atlas. Their response may be found in this link, which I believe is better read in the full context of the Vienna Protocol than summarized by your humble blogger. For those of you who must read the opinion before reading the entire protocol, please follow the link and scroll to the 4th to last page at number 12 in section C entitled “The Protocol and Recommendations”.

The evil that created the Pernkopf atlas was the Nazi occupation of and executions that occurred in Austria during World War II. It is no longer occurring. No one in the present is suggesting that we resume executing people to gain more anatomic drawings to complete additional volumes of the atlas. Any good resulting from the current use of the atlas isn’t being offset by any ongoing evil of creating more atlas. The evil of the Pernkopf atlas is contained in the past and, in that sense, finite. Containing the evil seems to be a necessary step in obtaining good from that evil.

I mention this in closing as I believe there are current analogies of activities performed in the name of scientific good where we condone ongoing evil. Studying fertilized ova until sacrificing them on Day 14 (an evil) in the name of learning about human reproduction (a good) is one modern day example. In Vitro Fertilization done to obtain a healthy baby with genetic traits we want (a good) that results in the death(s) of other fertilized eggs we don’t want (an evil) is another. There are other examples we have discussed within this blog. I believe we need to contain and hopefully discontinue these and other practices if we want to claim the information we gain can honestly be called good.

Technical steps to gene-edited babies

This blog has carried several comments about the prospect of heritable human gene editing.  While nearly no one currently supports bringing such babies to birth—and condemns those who would rush ahead to do so—it appears a distinct minority think that we the human race should, if we could, agree never to do such a thing.  The most cautious perspective is to advocate a moratorium.  Others in favor of proceeding argue that, in essence, with the technologic genie (my term, not necessarily theirs) out of the box, a moratorium, much less a ban, is futile; the “rogues” will press ahead, casting off restraint. 

Advocates of research in this area have argued that a clear, careful, regulated pathway is needed to guide the work through necessary laboratory experiments that should be done first, before making a woman pregnant with a gene-edited embryo, in an attempt to be sure that the process is safe and highly likely to yield the intended result.  Even a moratorium would be, by definition, temporary, leaving the question, “when we will know to remove the moratorium?” to be answered.

A feature article in Nature, accessible without a paid subscription, asks “When will the world be ready” for gene-edited babies.  It walks through scientists’ understanding of what the technical issues are.  It is longer than a blog post, so I can only list key points here.  It is worth a reading by anyone interested, and it is written in sufficiently non-technical language that it’s accessible to the general, non-scientist public.

Key concerns are:

  • How would we be sure that genes that were NOT intended to be edited, in fact were not?
  • How would we be sure that genes that ARE intended to be edited are edited correctly?

These two matters have been addressed to some degree, or could be, in animals, but that would be faster and easier than in human egg cells or human embryos, and the results in animals may be different from what is found in the embryos.  (A further question is how many embryos, observed for how long, would need to be studied to support confidence.)

  • Even if the intended gene edit is made, is it clear that doing so is safe and does not induce other health risks? 

This blog recently reported the UK study that suggested that changes in the gene edited in the twin girls born in China last year might eventually reduce life span.  A criterion promulgated in 2017 by the National Academies of Sciences, Engineering, and Medicine was that the edited gene should be common in the population and carry no known risk (including, presumably, no increased risk) of disease.  Such knowledge is lacking for human populations, and what is believed known about the association of genes with risk of future disease has often been developed in Western populations, and may not apply to, for example, Africans.

  • At least some embryos would include some edited and some non-edited cells.  It would not easily be possible, if possible at all, to tell how many of which were present, or needed to be for the editing to work and not cause risks to the embryo’s development into a baby and beyond.  And what answers were obtained would require manipulating healthy embryos after in vitro fertilization.  The outcomes could not be predicted from first principles.
  • What should a clinical trial look like?  How many edited children would have to be born, and their health (and, most likely, the health of their progeny) observed for how long to get provisional answers before practicing the technique more widely?  Or, would the work proceed as IVF did—with dissemination in the general public, and no regulated research?

A US and UK committee is planned to address these questions, with the intent of proposing guidelines in 2020.  This will be important to follow, but with no chance to affect.  Most of us will just be watching, which leads to the last concern:

  • Is the world ready?

If that means, is there an international, or even a national, consensus, then the answer is clearly “no.”  That almost certainly remains “no” if one asks whether there is a future prospect for consensus.  It’s hard to envision something other than different groups and nations holding different judgments, and, most likely, remaining in some degree of irresolvable conflict.

Are AI Ethics Unique to AI?

A recent article in Forbes.com by Cansu Canca entitled “A New Model for AI Ethics in R&D” has me wondering whether the ethics needed for the field of Artificial Intelligence (AI) requires some new method or model of thinking about the bioethics related to that discipline. The author, a principal in the consulting company AI Ethics Lab, implies that there might be. She believes that the traditional “Ethics Oversight and Compliance Review Boards”, which emerged as a response to the biomedical scandals of World War II and continue in her view to emphasize a heavy-handed, top-down, authoritative control over ethical decisions in biomedical research, leave AI researchers effectively out-of-the-ethical-decision-making loop.

In support of her argument, she cites the recent working document of AI Ethics Guidelines by the European Commission’s High-Level Expert Group on Artificial Intelligence (AI HLEG). AI HLEG essentially distilled their AI ethical guidelines down to the familiar: Respect for Autonomy, Beneficence, Non-Maleficence, and Justice, as well as one new principle: Explicability. She downplays Explicability as simply the means to realize the other four principles. I think the demand for Explicability is interesting in its own right and will comment on that below.

Canca sees the AI HLEG guidelines as simply a rehash of the same principles of bioethics available to current bioethics review boards, which, in her view, are limited in that they provide no guidance for such a board when one principle conflicts with another. She is also frustrated that the ethical path researchers are permitted continues to be determined by an external governing board, implying that “researchers cannot be trusted and…focuses solely on blocking what the boards consider to be unethical.” She wants a more collaborative interaction between researchers and ethicists (and presumably a review board) and outlines how her company would go about achieving that end.

Faulting the “Principles of Biomedical Ethics” for failing to be determinant on how to resolve conflicts between the four principles is certainly not a problem unique to AI. In fact, Beauchamp and Childress repeatedly explicitly pointed out that the principles cannot be independently determinant on these types of inter-principle conflicts. This applies to every field in biomedical ethics.

Having an authoritative, separate ethical review board was indeed developed, at least in part, because at least some individual biomedical researchers in the past were untrustworthy. Some still are. We have no further to look than the recent Chinese researcher He Jiankui, who allegedly created and brought to term the first genetically edited twins. Even top-down, authoritative oversight failed here.

I do think Canca is correct in trying to educate both the researchers and their companies about bioethics in general and any specific bioethical issues involved in a particular research effort. Any effort to openly identify bioethical issues and frankly discuss potential bioethical conflicts at the outset should be encouraged.

Finally, the issue of Explicability related to AI has come up in this blog previously. Using the example of programming a driverless car, we want to know, explicitly, how the AI controlling that car is going to make decisions, particularly if it must decide how to steer the car in a no-win situation that will result in the death of either occupants inside the car or bystanders on the street. What we are really asking is: “What ethical parameters/decisions/guidelines were used by the programmers to decide who lives and who dies?” I imagine we want this spelled-out explicitly in AI because, by their nature, AI systems are so complex that the man on the Clapham omnibus (as well as the bioethicist sitting next to him) has no ability to determine these insights independently.

Come to think about it, Explicability should also be demanded in non-AI bioethical decision-making for much the same reason.

Informed Consent and Genetic Germline Engineering

By Mark McQuain

I recently read, with admittedly initial amusement, an article from The Daily Mail that described a young man of Indian decent who was intending to sue his parents for giving birth to him “without his consent.” Raphael Samuel, a 27 year-old who is originally from Mumbai, is part of a growing movement of “anti-natalists”, who claim it “is wrong to put an unwilling child through the ‘rigmarole’ of life for the pleasure of its parents.” While he claims he loves his parents and says they have a “great relationship”, he is bothered by the injustice of putting another person through the struggles of life “when they didn’t ask to exist.”

While I was amused at the absurdity of asking a non-existent entity for permission to do anything, I began to wonder whether my position against germline genetic engineering should continue to include the lack of informed consent by the progeny of the individuals whose germline we are editing.

I have made the claim on this blog previously that one of my arguments against germline genetic engineering is that it fails to obtain the permission of the future individuals directly affected by the genetic engineering. Ethical human experimentation always requires obtaining permission (informed consent) of the subject prior to the experiment. This goes beyond any legal issue as many would consider Autonomy the most important principle of Beauchamp and Childress’s “Principles of Biomedical Ethics”. Informed consent is obviously not possible for germline genetic engineering as the future subjects of the current experiment are presently non-existent at the time of the experiment. While I believe there are many other valid reasons not to experiment on the human genetic germline, should the lack of informed consent continue to be one of them?

In short, if I am amused at the absurdity of Mr. Samuel’s demand that parents first obtain their children’s permission to be conceived prior to their conception, is it not equally absurd to use the lack of informed consent by the progeny of individuals whose germline we are editing as an additional reason to argue against genetic germline engineering?

Gene editing for genetic enhancement

By Steve Phillips

I appreciate the prior posts by Jon Holmlund and Mark McQuain regarding the recent announcement of the birth of genetically modified twins in China. Much has been written about why this should not have been done, but something very significant has been left out of most of those responses. They have failed to mention that the scientist who created the genetically altered twins was doing a form of genetic enhancement. As I have noted before, the only real reason for anyone to do research on the genetic modification of human embryos is to enable the possibility of human genetic enhancement. The scientist involved in this situation has recognized that and directly pursued it. I suspect that his open pursuit of enhancement is one of the reasons why he has received such a negative response from those who otherwise support the permissibility of using human embryos for experimentation on germline genetic modification.

The primary argument presented for why this was wrong is that he has subjected two healthy human infants to the unknown risks of genetic modification without any corresponding medical benefit to the infants. The modification was disabling the gene that codes for a cell membrane receptor that the HIV virus commonly uses to gain entry into cells it infects. The hope was that these infants would have enhanced resistance to HIV infection, although not complete immunity to such infection. The infants themselves would not have been at increased risk for HIV without the modification, but the parents had a desire to have children with increased resistance because their father has HIV and is aware of the difficulty of living with the disease. Thus, the modification was being done to provide an enhancement desired by the parents and was not being done to infants would have otherwise suffered from a genetic disorder.

Most who support current research to develop effective techniques for human germline genetic modification take the position that the safety of doing this has not been established well enough to use the technique to create infants and that when the research does reach the point that genetically modified human infants are created it should only be in situations in which those infants would otherwise have had serious genetic disorders. They are correct that this technique is currently unsafe but fail to realize that we will probably never be able to establish the safety of this type of genetic modification, because that would require safety data from multiple generations of these infants’ offspring. The idea of restricting this technique to infants who would have been born with serious genetic disorders and the idea that this technique could be used to rid the world of these genetic disorders does not make sense. If a couple desires to have children and know that they are at risk to have a child with a serious genetic disorder and have no moral concerns about the destruction of human embryos involved in such things as genetic modification, they can pursue selection of an unaffected embryo using PGD and have no need to take on the additional risks of genetic modification. Using genetic modification to eliminate genetic diseases would require a Brave New World scenario in which all human beings are artificially conceived and natural conception is prohibited. Therefore, the only reason to pursue the genetic modification of human embryos is for the purpose of human enhancement.

Let me be clear that I agree that what the scientist has done is wrong because he has subjected these two infants to significant risk without any significant medical benefit. That is always wrong. However, the strength of the negative response from those who generally support research to develop human germline genetic modification is likely due to the fact that he has opened up to public scrutiny the real purpose of such research. He has also shown that it is not true that we can ignore ethical concerns about enhancement because we could regulate the use of genetic modification so that would not occur. Enhancement was the goal of the very first use of this technique to produce human infants.

Bioethics & “Three Identical Strangers”

By Neil Skjoldal

I recently had the opportunity to watch the 2018 documentary Three Identical Strangers, which tells the story of triplets Bobby Shafran, Eddy Galland, and David Kellman.  They were separated shortly after birth in the 1960s and adopted by three different families through the Louise Wise adoption agency in New York City.  The way they happen to find out about each other in 1980 is fascinating.  It created a media sensation at the time, including an appearance on The Phil Donahue Show.

The documentary starts by sharing their thrill of discovery, which included the many similarities that the brothers have, even though they spent the first 19 years of life apart.  However, it eventually moves to some of the larger and darker questions that lingered for each of the adoptive families—the biggest of which was, “Why weren’t we told that there were siblings?”  And as you might suspect, the agency representatives did not provide many helpful answers.  The parents’ feelings of anger and bewilderment resonated with me as an adoptive parent.

Eventually the brothers came to find out that they were part of a “twins study” conducted by noted psychologist, Peter Neubauer.   The study involved the brothers being interviewed and filmed individually every year through the first few years of their lives, with them not knowing that their brothers even existed.  Their parents were told it was a study of adopted children, not a study of twins.

The documentary leaves little doubt where it stands on the ethics of this matter.  From some of those interviewed, it appears that the purpose of the study was to address the classic “nature vs. nurture” question.  However, the harm done to these brothers (and the others who were unknowingly involved in the study), making them feel like ‘lab rats,’ undermines any positive value that the study may have had.  That Neubauer’s research remains sealed at Yale until 2066 adds fuel to the fire that something unethical was done.

In a blog post on www.psychologytoday.com, Dr. Leon Hoffmann asks whether it is reasonable to expect researchers of previous generations to follow our contemporary standards.  He asserts that both the original researchers and the producers of the documentary are guilty of self-deception.  This is a point worth considering as we look back; however, this case is from the 1960s and those impacted are still very much alive.

It is difficult for me to disagree with the assessment of reviewer Neta Alexander of www.haaretz.com:  “’Three Identical Strangers’ is thus a faithful representation of the spirit of the times. It’s about the way in which the authorities and those with power – headed by a charismatic and respected psychologist – abuse their powers in the name of science.”  Three Identical Strangers stands as a timely reminder that there should be safeguards and limits to research.

Public input into gene-editing decisions

Lyme disease is caused by a type of bacteria that lives in mice, which are considered a “reservoir” for the disease-causing agent.  Ticks bite the mice, pick up the bacteria, and then infect people when they bite them.  (Ticks are called the “vector” for the disease.)

If mice were immune to the bacteria, their immune systems would destroy them, and there’s be no reservoir, and no Lyme disease.  If scientists genetically engineered mice to make them immune—for example, by editing their genes—they could make progress toward that goal.  But to work, the mouse population would have to be predominantly made of bacteria-immune mice.  That could be accomplished by using “gene drive,” an approach that would make the altered gene spread preferentially and rapidly in the population.  However, doing that could alter the environment in unpredictable ways.

Because of the risks, scientists on the “Mice Against Ticks” project are determined that even if they succeed in genetically altering mice as suggested, they will not release those mice into the wild without full public awareness and approval.  They are holding public meetings—specifically, in Martha’s Vineyard and Nantucket—well in advance of the project coming to full fruition.  And they are trying to figure out, with the public, what level of communication and acceptance constitutes public approval.

Similarly, scientists in New Zealand would like to use a form of gene drive to greatly reduce the population of rats, possums, and other destructive predators that are decimating the environment.  And their public deliberations include seeking advice and, before taking action, buy-in from a network of Maori leaders.  Those conversations are so sensitive that the Maori objected when the scientists published a “what-if” type of article discussing the issues raised by the technology.  Among the concerns: some readers got the impression that gene editing of the animals was imminent, not hypothetical, as it still is.  Some of the news coverage of the Nuffield Council’s recent deliberations about the potential acceptability of heritable human gene editing seemed, likewise, to create the impression that the birth of the first gene-edited human is upon us—which it is not, not quite yet.

The public discussions above are two commendable moves toward true public involvement in decision-making about gene editing.  They were described in a recent Wall Street Journal article.  If you have subscription access, by all means read it.

A safety concern with gene editing

BY JON HOLMLUND

Hat-tip to Dr. Joe Kelley for bring this to my attention…

As readers of this blog will recall, there is keen interest in exploiting recent discoveries in genetic engineering to “edit” disease-causing gene mutations and develop treatments for various diseases.  Initially, such treatments would likely use a patient’s own cells—removed from the body, edited to change the cells’ genes in a potentially therapeutic way, then return the altered cells to the patient’s bloodstream to find their way to the appropriate place and work to treat the disease.  How that would work could differ—make the cells do something they wouldn’t normally do, or make them do something better than they otherwise do (as in altering immune cells to treat cancer); or maybe make them work normally so that the normal function would replace the patient’s diseased function (as in altering blood cells for people with sickle cell anemia so that the altered cells make normal hemoglobin to replace the person’s diseased hemoglobin).

Or maybe we could even edit out a gene that causes disease (sickle cell anemia, Huntington’s disease) or increases the risk of disease (e.g., BRCA and cancer) so that future generations wouldn’t inherit it.  Or maybe we could edit genes to enhance certain health-promoting or other desirable qualities.

The recent scientific enthusiasm for gene editing is fueled by the discovery of the relatively slick and easy-to-use (if you’re a scientist, anyway) CRISPR-Cas9 system, which is a sort of immune system for bacteria but can be used to edit/alter genes in a lot of different kinds of cells.

It turns out that cells’ normal system to repair gene damage can and does thwart this, reducing the efficiency of the process.  The key component to this is something called p53, a critical protein that, if abnormal, may not do its repair job so well.  When that happens, the risk of cancer increases, often dramatically.  In cancer research, abnormal p53 is high on the list of culprits to look out for.

Two groups of scientists, one from the drug company Novartis and one from the Karolinska Institute in Sweden, have published on this.  P53’s thwarting of gene editing is particularly active in pluripotent stem cells, that are some, but not the only, candidate cells to be edited to create treatments.  These cells are also constituent cells of human embryos.  If the CRISPR-Cas9 process is used on these cells, p53 usually kills them off—unless it’s lacking or deficient, in which case it doesn’t, but also in which case it means that the altered cells could themselves become cancers, later on.

This is something that has to be monitored carefully in developing cells as medicines, so to speak, with genetic editing.  One does not want the patient to appear to be healed, only to develop a cancer, or a new cancer, later on.  One certainly would want to know the risk of that before editing an embryo—an unborn human, a future baby if placed in the right environment—to create a gene-edited human being.

Yet, as I’ve written here in the past, it appears that experimentation in heritable gene editing is pressing on.  I’ve argued, and continue to argue, that heritable human gene editing is a line that must not be crossed, that would place too much trust in the providence of the scientists/technologists who are the “actors” exerting power over fellow humans who become “subjects” in a deep sense of the term; that the risks to the subjects are undefinable; that it would enable perception of humans as “engineering projects”; that the gift of life would tend to be replaced by seeking to limit birth to “the people we want”; that the people acted upon are unable to provide consent or know what risks have been chosen for them by others, even before birth.  Rather than press ahead, we in the human race should exercise a “presumption to forbear.”

A counter argument is that, in limited cases where the genetic defect is limited and known, the disease is terrible, treatment alternatives are few or none, that the risks are worth it.  The recent papers seem to expose that line as a bit too facile.  How many embryos created (and destroyed) to develop the technique before “taking it live?”  Could we work things out in animals—monkeys, maybe?  How many generations to alter, create, and follow to be sure that a late risk—such as cancer—does not emerge?  Or maybe our animal rights sensibilities stop us from putting monkeys at such risk—maybe mice will do?

The new papers are dense science.  Frankly, I can grasp the topline story but have trouble digesting all the details.  More sophisticated readers will not be so impaired.  The news report, in the English of the general public, can be read here, the Novartis and Karolinska reports read (but not downloaded or printed) here and here, respectively.