“The Babies are the Experiment”

By Jon Holmlund

 

The Thursday, Dec 13 edition of the Wall Street Journal carries this headline:  “Doubts Arise Over Gene-Editing Claim.”  The work behind the recent report that the world’s first two gene-edited babies had been born has been publicly discussed, but the details have not yet been published for full scientific review.  Apparently scientists in the gene-editing field are reviewing the public presentation and finding it lacking:

  • Some, but not all, of the cells in the children may have been edited. One would expect changes in all of the cells, and this should be necessary for the overall stated medical goal (protection from HIV infection) to have a chance of having been met.

The edited babies may have variants of the edited gene that have not been fully studied and could have unforeseen health consequences.

The technique used to confirm the gene changes may not be sensitive enough to detect whether other, unintended and potentially undesirable gene changes had been made.

And perhaps most notably, the studies done in mice to demonstrate the feasibility of the technique, before editing the embryos that grew into the full-term babies, involve a different change in the target gene in mice than the change sought in the children. In other words, the animal studies appear not to be representative of the human situation.

This is a common problem for development of new treatments for cancer and other diseases.  Tests are initially done in animals—usually mice—to determine whether the putative new treatment appears to be working.  The animal models used never entirely reflect the human disease.  Some come closer than others.  But the way of handling that uncertainty is to define and limit the risks to people who subsequently have the new treatment tested on them in clinical trials.

In the case of the gene-edited babies, there’s really no way to limit the potential risks, at least not yet, if ever.  Ultimately, one has to strike out and make changes that could backfire for the recipient humans, or be propagated into their descendants with unpredictable effects. 

Accordingly, without good animal models, and appropriately extensive testing in them, then, as professor Sean Ryder of the University of Massachusetts Medical School is quoted as saying, “the babies are the experiment.”  Ultimately, heritable gene editing may just require a leap of biomedical faith.

We should just say, “no, we shall not.”

Human Embryos as Raw Materials

By Jon Holmlund

 

This past Tuesday, the Presidential Symposium at the 2018 Annual Meeting of the American Society of Hematology (ASH) addressed human gene editing.  The speakers included NIH Director Dr. Francis Collins, who spoke about somatic gene editing.  That’s the attempt to edit disease-causing genes in existing, fully formed individuals who have the disease in question, as treatment.  It’s generally well-addressed by our current ethical principles for human subject research, and it’s easy to agree that it is an appropriate use of gene editing technology, which has become so widespread—and, indeed, largely uncontrollable—because of the recently-discovered, highly efficient, easy-for-scientists-to-use CRISPR-Cas9 system.  The NIH has a specific Somatic Cell Gene Editing program.

Dr. Collins was followed by Dr. George Daley of Harvard, who presented a thoughtful case for proceeding with heritable gene editing—i.e., of germ cells (eggs and sperm) or, more likely, embryos, specifically during in vitro fertilization.  The recent editing of twin babies, announced in Hong Kong, was highly irresponsible, he said—in agreement with the vast majority of expert and general public commentators.  Fundamental principles of human subject research had been disregarded.  We must do what we can to guard against “hubris.”  Nonetheless, he agreed with the U.K.’s Nuffield Council opinion of earlier this year that ethical uses of human gene editing can be imagined.  Specifically, rare, serious genetic diseases untreatable by other means would qualify.  But rarity should not be a rigid requirement; there might be other genetic diseases for which future research would identify heritable gene editing as a viable if not preferred approach.  A “stop sign” or “red light” should be erected at enhancement—e.g., trying to edit genes to get more muscular or smarter people.  But this seems like a distant prospect.  Dr. Daley ended by endorsing a statement of the recently-concluded international symposium on gene editing in Hong Kong:  a “rigorous translational path” should be defined for human gene editing.  In everyday English:  steps to refine the technique in the laboratory should be taken, and steps needed to bring that work to the editing of people should be identified, in much the way that current regulated new drug development follows a series of well-defined steps.

But the actual translation should not go forward until there has been serious consideration of the societal and ethical concerns.  Some such efforts are happening now, he said.  I’ve blogged over the last few years about some of these, but you may not have heard of many, much less had a chance to contribute or had any way of thinking that concerns you might have would be properly represented.  Indeed, as I have said on this blog earlier this year (see my March 29 post, for example), it’s hard to imagine how to conduct social deliberation of the scale required by the utterly revolutionary prospect of human gene editing.  In a Q+A panel session, Dr. Collins asked Dr. Daley whether the answer to such deliberations might be “no”—might there be a decision not to proceed at all with editing human embryos?  Dr. Daley said, “yes, of course,” but I wonder.  For his part, Dr. Collins had sounded a highly cautionary note:  Embryo editing raises serious safety concerns, issues of informed consent, and questions about what it is to be human, he had said.  Perhaps its proper use would be so narrowly circumscribed that it really is not worth the trouble.  “Bad cases make bad law,” as it were, he had said.

After my post of last week, an inquirer had wondered aloud whether someone contributing to this blog might be able to figure out how many embryos had been destroyed in the run-up to the Chinese twins’ birth, or, for that matter, for the other laboratory experiments done so far in human gene editing.  Skeptical that such data exist anywhere, your correspondent nonetheless asked Dr. Daley in the Q+A whether there was any way reliably to estimate the “supply need” (I used that phrase) for human gametes or embryos in the course of the “rigid translational path.”  Dr. Daley of course could not make any more precise estimate than “very many embryos” would have to be destroyed in the process.  I must concur; I cannot see how a quantitative estimate could be made.  He allowed that moral objection to this would be one of the issues with this work, and commented that in the U.K., plans are to issue licenses for the necessary embryo experiments as part of an attempt to regulate them.

But the emerging picture is that human embryos are “raw materials” supporting the “translational” development of heritable gene editing, much as starting chemicals are raw materials for the production of a new drug.  That production process is governed by a panoply of regulations collectively referred to as “Good Manufacturing Practice,” a term that was applied to human gene editing more than once in the aforementioned ASH symposium.

I also asked whether the so-called “14-day rule” that scientists voluntarily follow as a time limit on human embryo research—i.e., don’t let them get more than 14 days old before killing them—would have to be relaxed.  Dr. Daley thought not.  I must say I wonder.  If embryos could be maintained in the lab for more than 14 days—something that still is not technically feasible, but is being actively contemplated by scientists in the field—might someone not insist that their development be followed as long as possible before taking the step of trying to bring them to term—that is, to full pregnancy and birth?

Perhaps not.  Unless more sophisticated “hatcheries” are developed, edited embryos would have to be implanted in a woman’s womb, after which there would be a progressively stronger presumption against aborting them, the older their gestational age.  But such a presumption would not be absolute under current American law and jurisprudence.  To be sure, the later a research abortion—currently prohibited in the U.S.—the greater a risk to a pregnant woman, not just the fetus being aborted.

And other intrepid actors, somewhere in the world, might well try to proceed outside a fully-regulated framework, purposefully setting up assessments at various gestational ages.

I must add that one liability of the line of thinking I have been taking here is that it might promote the misconception that the principal or even only reason to object to heritable human gene editing is a “pro-life, anti-abortion, religious” concern about the moral status of human embryos.  Not so, although the status of the embryo is a critical consideration.  There are lots of other reasons to object to this revolutionary development, and to say, as Dr. Collins suggested that “the answer should be ‘no.'”

About which more, much more, in the coming weeks.

 

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.

The Genetic Singularity Point has Arrived

By Mark McQuain

November 2018 will go down as one of the most pivotal points in human history. Jon Holmlund covered the facts in his last blog entry. Regardless of what you think about the ethics of He Jiankui’s recent use of CRISPR to alter the human genomes of IVF embryos and his decision to intentionally bring those genetically altered twin girls to full term, one thing is perfectly clear – we humans are in charge now. Whether you believe in God or Nature as the Entity or Force that previously determined the arrangement of our genes, humans now sit at the adult table and will be gradually (rapidly?) making more of those genetic decisions. Like Kurzweil’s upcoming Singularity Point when computers develop sufficient artificial intelligence to design the next computer, humans have now reached the point where we can and are willing to design the next human.

The Genetic Singularity point has arrived.

While there are some scientists who are frustrated that our Institutional Review Boards and ethics committees have held us back this long, most of the rest of us are frankly stunned and uneasy that we have reached this point. But anyone who thinks our stunned uneasiness will prevent a repeat of this experiment or prevent a push to alter increasing portions of our human genome to change other genetic sequences will simply remain more frequently stunned and persistently uneasy, ethical arguments notwithstanding.

My reason for expecting this to be the case is I believe we will hear increasing demands of the form that now that we have the ability to change our genome, we have the responsibility to change our genome. In fact, it would not surprise me to see, in the not-to-distant future, insurance companies paying for the cost of IVF/CRISPR to modify your child’s genome to prevent disease/condition X to avoid paying for the later treatment of disease/condition X. Oh, you won’t be forced to do this. But, if you choose to rely on God or Nature for your baby’s genetic pattern, “we” won’t be responsible for his or her care. And, if big data can eventually be married to IVF/CRISPR to statistically improve one’s chances of having a smart/beautiful/athletic/successful baby, wouldn’t you want the same for your child? Since it will be our responsibility, how could a parent not choose to make their child the best that they could be?

This will be Gattaca writ large.

Being at the Genetic Singularity point, by definition, means we humans choose our next step. We have reached the point where we believe we are ready to select our future direction. It is up to us now to chart our own course. Our genetic trajectory is our responsibility. Our success or failure, or more broadly, our future good or bad, is finally ours to determine – really ours to assign.

So Man created mankind in his own image, in the image of Man he created them…And Man saw everything he had made, and behold, it was very good…

Approaching Immortality?

By Neil Skjoldal

With the death of President George H. W. Bush this past weekend, the country seems united in eulogizing him for, among other things,  having lived “a well-lived life,” because amidst his accomplishments, he was able to reach 94 years of age.  This brought to mind a recent article published in The NY Times, “How Long Can People Live?”  In it, health writer Nicholas Bakalar observes, “There is considerable dispute, however, over how long humans might live under optimal circumstances.”

The brief article discusses the possibility of drug therapies designed to kill old cells, while leaving young cells in place.  Apparently many are working on research projects to see what may be possible.  Even the well-known drug metformin will be tested to see its effectiveness against age-related diseases.   Bakalar is not overly optimistic.  He clearly states, “No serious scientist believes in immortality.”   Rather the goal is to assure a “healthier old age than ever before.”

I find Bakalar to be reasonable in his assessment.  Of course, one can question whether trying to extend life past 100 years is the best use of limited resources when there are so many other health issues with which to contend.  However, perhaps a ‘healthier old age’ could reduce some of those very high medical costs at the end of life which seem to plague our health care system.

I do not anticipate that I will be jumping out of an airplane at an advanced age like President Bush, but I am interested to see if any of the health issues related to old age can be addressed in a meaningful way.

The Genie is Out of the Bottle

By Jon Holmlund

 

Much has already been written and said—mostly in condemnation–about this week’s announcement of the birth of the first gene-edited baby (or, better, babies—there are twins).  A gene was altered in embryos created through in vitro fertilization, and then the embryos were transferred to their mother, who carried them to term and, reportedly, normal delivery.  The babies are said to be in good health.

A couple of good summary articles, written for non-specialists, are online from Science News and the science journal Nature. Follow those links to read more than your correspondent can write here in a short blog post.

The scientist who did this used the CRISPR-Cas9 system to alter a gene called CCR5, which is a receptor, or docking post, for the HIV virus.  Presumably, altering CCR5 would reduce the risk of HIV infection if not prevent it altogether.  The twins’ mother is reportedly not infected with HIV, but the father is.  How much risk this placed the babies at is questionable—usually, babies infected with HIV become infected because of transmission from an infected mother.  HIV can cause infection through other receptors, and altered or disabled CCR5 can increase risk of other infections.  So, overall, the medical need was questionable, there were (actually, are, one needs to see how their health is in the future) potential correlative risks to the babies, and there were likely other means to avoid what appears to have been an unlikely prospect of these babies getting HIV from their father.  Because of concerns like this, ethicists have been arguing that the action violates human research ethics, in which risks to subjects must be minimized, and benefits must outweigh risk.  Any ethics board reviewing a proposal would assess this rigorously, and ask whether there are safer alternatives to the research.

The experiment is said to have worked in this sense—analysis of their DNA shows that the target gene, and no other genes, was altered as intended.  Clearly, the rationale for the editing was to show that it could be done.  George Church, ever the risktaker in the name of “advancing the field,” argued in an interview that because HIV is incurable and there is no vaccine for it, that constituted an unmet medical need in this case.  He also argued that the scientist in question only failed to complete the proper “paperwork,” and that there might be long-term safety issues with heritable gene editing but that would not be dispositive because he is quite confident that those risks will be small, like the risks of diagnostic medical imaging.  To all of which we must respond, “rubbish.”  We do not know what the long-term risks are, ethics boards are rigorous about risk assessment for any and all experimental procedures, and the medical need in this specific case was dubious.

Nature reports that this work “has prompted an outcry from scientists, who are concerned that [the scientist] leap-frogged international discussions on the ethics of such interventions and has put the children at risk of unknown long-term health effects. ‘This experiment exposes healthy normal children to risks of gene editing for no real necessary benefit,’ says bioethicist Julian Savulescu.”  For those who are not formal students of bioethics, Julian Savulescu is hardly a Luddite or a God-fearer who is nervous about new technologies.  He’s right, in this case.

Note the concern about “leapfogging” discussions of the ethics.  This point is also well-taken.  Scientists have been arguing that broad, public discussion of the ethics of human gene editing is urgently needed.  On March 29 of this year, your correspondent—who is scrambling to catch up even to this week’s commentary—posted about two such arguments.

But the genie is out of the bottle, and things are moving faster than most folks can keep up with.  The work reported this week was from China, but was not part of some Chinese government effort—it appears to have been entirely on private, intrepid initiative.  As a writer in the San Diego Union Tribune wrote this week, Pandora’s box has been opened and can’t be closed.

This week’s announcement came at the international conference on gene editing, in Hong Kong.  The two days’-plus of proceedings, including a session with the scientist who did the work discussed here, can be accessed online.  The conference main web page is here.  The proceedings archived on webcast appear to be accessible here.  A summary of the Q+A with the scientist is here.

Oh, BTW—at the end of the Nature summary linked at the top of this post was a chance to vote on whether this application of gene editing was justified.  I voted “no,” as did 82% of respondents at the time I voted.  That left “yes” at 18%.

18%?? For real?

Thanksgiving and ethics

By Steve Phillips

It is good at times for us to stop and think about why we do the things that we do and what they mean. Tomorrow is Thanksgiving Day, a holiday that our society enthusiastically celebrates with lots of food, the gathering of families, and sporting events, followed by intense shopping. Historically Thanksgiving in America began with a group of Christians expressing their gratitude to God for what he had done for them. Christians continue to see this holiday as one during which we pause to remember what God has done for us and take time to express our thanks to him.

However, many in our society no longer believe in a personal God to whom gratitude is due. What does it mean to celebrate Thanksgiving if a person believes that those things that they are pleased to have are theirs due to a combination of chance and their own effort? Or if in our entitlement culture they believe that all that they have are things that they deserve. If that is the case, there is no reason for giving thanks and no one to whom thanks can be given. Instead of being a time of actually giving thanks to the one who has graciously given good gifts to us, the holiday has become a celebration of affluence and good fortune. Sporting events and shopping fit that very well.

How does this relate to ethics? The two different meanings of Thanksgiving correspond with two different ways of thinking about how we ought to live. For those of us who see Thanksgiving as a time to remember that the good things that we have come from God, it also reminds us that we are created beings who are made by and dependent on the God who has given us the things that we are thankful for. Remembering this helps us realize that God is the source of all that is good and that our understanding of what is right and how we ought to live comes from him as well. The alternative meaning of the Thanksgiving celebration is self-focused. If there is no God to be thankful to, the celebration is about the fulfillment of personal desires. That correlates with the ethics of moral individualism in which moral values are based on how a person feels and focused on fulfillment of personal desires.

Whether we see Thanksgiving Day is a time to actually give thanks to the God who is the giver of all good things or not makes a big difference in how we think about ethics.

Sprinting Down the Road on “The Children We Want”

By Mark McQuain

Almost exactly one year ago, this blog asked rhetorically whether your polygenic risk score was a good thing. Jon Holmlund raised this issue again last week, mentioning a company called Genomic Prediction. This company’s claim about the merits of their technology deserves close ethical scrutiny and is my reason for mentioning them yet again.

Genomic Prediction is increasingly calling for IVF clinics to use their version of expanded pre-implantation genetic diagnosis (EPGD), that is using big data analysis to select which embryo to implant – literally choosing the embryo you want based not upon the presence of single point genetic mutations known to be harmful but polygenic sequences (multiple genes, and even multiple upon multiple genes) statistically related to increased risk for complex diseases like heart disease and diabetes. Jon discussed the ethics of selecting “the children we want”, hinting that selecting for eye color or sex was “a step” further down the road.

Genomic Prediction is sprinting down that road.

Just last month, Genomic Prediction entered into discussion with some IVF clinics in the U.S. to screen embryos for “mental disability”. Per the firm’s co-founder Stephen Hsu:

“[EPGD] isn’t accurate enough to predict IQ for each embryo, but it can indicate which ones are genetic outliers, giving prospective parents the option of avoiding embryos with a high chance of an IQ 25 points below average”

This claim is entirely different from a claim that this particular embryo has this particular single point mutation that will cause this particular disease. Rather, the present claim of EPGD is better stated like this: When we saw this same polygenic pattern in some large number of prior embryos, a majority of them had an IQ 25 points below normal. Some questions naturally follow: Did any have above average IQs (and how far above average)? How big is the majority (75%, 85% or 97%)? How many embryos were studied to come up with this statistic?

Gamblers like Las Vegas odds makers are beginning to use big data analysis to better predict the outcome of sports contests. The result is that the Las Vegas odds makers can tell us that when number one ranked University of Alabama plays unranked Citadel in 1000 football games, Alabama will win 999 times. That also means that Citadel will win one of those 1000 games, and, prior to the start of the game, you never know which of those 1000 games you are watching. Last weekend, at halftime, Alabama and Citadel were tied 10-10. At that point, it looked like Citadel was going to win that one game out of 1000 and defy the odds makers.

And that is the point. Many have already decided this it is good to terminate the life of an embryo if he or she has a point mutation for a serious disease. Is it just as good to terminate the life of an embryo if he or she has the mere risk of some non-disease trait we find undesirable like the wrong eye color, sex or intelligence? Do we really have sufficient data to make this decision? How much risk is too much or too little? How do we know if the decision is a good one? Will the decision get us the “Children We Want”? Is it really our decision to make?

It is necessary we answer questions like these if we wish to take on the responsibility to decide who lives and who dies, a decision that we previously relegated, depending on your worldview, to God or Nature.

A Bit More on “The Children We Want”

By Jon Holmlund

 

The Wall Street Journal recently asked “Is it ethical to choose your baby’s eye color?”  This can’t be predicted precisely, yet, because the inheritance involves several genes, but in principle it’s at least possible to play the odds by trying to predict the probability of eye color.  The article in question discusses how one clinic, Fertility Institutes in Encino, CA, is offering an “eye color probability” test (my term, not their) as part of embryo screening, for $370.  From the website, it looks like Fertility Institutes offers the whole 9 yards of reproductive technology—egg freezing, embryo sex selection, preimplantation genetic diagnosis (PGC), surrogacy, and so on.

Also mentioned is a New Jersey-based company, Genomic Prediction, that is offering “expanded” PGD to predict which embryos are at high risk for developing heart disease or diabetes.

I suppose by including the links to these entities I’m providing them free advertising, but I thought it important to document where information can be found.  I am NOT endorsing their services.

I take a conservative position on these technologies, and have been suspicious of IVF itself, since before its advent in 1978 (when I was in college), as fundamentally separating sex from procreation.  Here, however, the larger point is that, as we use PGD to predict an increasing range of traits, we adopt, little by little, an attitude of requiring that children entering the world are “the children we want.”  Even if one argues for PGD to screen for very severe genetic defects that would be incompatible with robust life—or maybe life at all beyond a few days or even hours—it is harder to argue for screening out people who may be at risk for diseases like diabetes but who otherwise could live very full lives.  Ditto for risk of heart disease, or breast or ovarian cancer, or the presence of Down Syndrome, or even Huntington’s disease.  And selecting for sex or eye color is a step further down the road as well.

Watch GATTACA if you’ve never seen it.  That’s the extreme, sci-fi scenario—but as with gift giving, it’s the thought, the motive, that counts.

Abortion by mail, part 2

By Steve Phillips

Last week I wrote about a European organization that has begun providing the medicines used for medical abortions by mail to women seeking abortions in the US following an online consultation. This violates the current restrictions that the FDA has on the prescribing of mifepristone, the primary medicine used for medical abortion. The restrictions exist due to safety concerns with the use of the drug. Those who think that those restrictions should be ended cite FDA statistics that show that serious harm to women who take the drug are quite rare. I concluded that the data indicate that it is hard to support the restrictions based on the risk of harm to a woman who chooses to use mifepristone.

I mentioned that there is another, somewhat perverse, risk that is usually not discussed which enters into the decision about whether the prescribing of should be limited to a certified prescriber dispensing the medicine in a clinical setting. That is the risk to the embryo/fetus. Those who support the use of mifepristone cite an effectiveness rate of 95-97%. That means that over 95% of the time the use of mifepristone in early pregnancy causes the death of the embryo/fetus and along with the use of misoprostol the pregnancy is ended with a medically induced abortion. In the 3 to 5% of cases in which this does not occur, some result in the death of the embryo/fetus, but the products of conception are retained within the uterus and may present some risk to the mother. As noted above, the observed risk to the mother turns out to be quite low. Sometimes when the process of medical abortion fails the embryo/fetus may survive. Mifepristone is an anti-progesterone. We know that medicines which alter the hormonal environment of an embryo can cause congenital anomalies. Therefore, there is a risk that if an embryo does not die and a subsequent surgical abortion is not done an infant may be born who suffers from congenital anomalies due to exposure to the medicines which were intended to cause a medical abortion. To prevent this, it is recommended that women who take the medicines for medical abortion who do not abort within the usual period of time have a surgical abortion. That would be the primary reason to support the FDA’s requirement that these medicines only be dispensed in a clinical setting by a certified prescriber. The role of the certified prescriber is to make sure that no embryo who is exposed to mifepristone survives to be born with the possible congenital anomalies.

Thus, we have a situation in which our society, as represented by the FDA, has decided that it is permissible to give a pregnant woman a medicine that will kill the embryo/fetus living inside her, but only if the medicine is dispensed in such a way that it can be assured that the embryo/fetus will be killed and not survive with an abnormality caused by the medicine. I said this was perverse. It is what we get when we have a society that puts a higher value on avoiding suffering than the value placed on human life.