Reproductive technologies like genetic testing, amniocentesis, in vitro fertilization and gene editing through CRISPR have shed light on many human illnesses and conditions that were once considered to be terrifying mysteries. On the other hand, there is also great potential for recklessness and harm created through these technologies, and the different ethical systems we use to make decisions around them often overlap and conflict. How can we bring wisdom from our cultural, civic and religious surroundings to bear on these issues, which are often ones of life and death?
Dr. David Snyder is chair of the Bioethics Committee at City of Hope Medical Center in Duarte, CA, and the Emeritus professor of Medicine at the Department of Hematology and Hematopoietic Cell Transplant.
Rabbi Elliott Dorff is Distinguished Professor of Jewish Theology at AJU and author of Matters of Life and Death, A Jewish Approach to Modern Medical Ethics, as well as Visiting Professor of Law at UCLA.
Dr. John Zaia is an HIV researcher (Aaron D. Miller and Edith Miller Chair in Gene Therapy) at the City of Hope, and Institutional Officer for City of Hope to the Food and Drug Administration/National Institutes of Health.
(This post is part of Sinai and Synapses’ project Scientists in Synagogues, a grass-roots program to offer Jews opportunities to explore the most interesting and pressing questions surrounding Judaism and science. “Medical Ethics and New Technology: We Can Do It – But Should We?” was an event held at Pasadena Jewish Temple and Center on December 1, 2022).
Judy Callahan: The Sinai and Synapses project bridges the religious and scientific worlds, and offers people a worldview that is scientifically grounded and spiritually uplifting. The project is the intersection of Judaism and science, and coexisting searches. We hope many of you were with us in September, when Dr. Thomas Rosenbaum, the president of Caltech, shared a wonderful evening of physics and faith. If you would like more information about Sinai and Synapses, you can go to their website, sinaiandsynapses.org (just spell it out), and they have wonderful presentations. And we will be telling you a little bit more about that at the end.
At this time, we are really honored to have this exceptional panel for our second program, where we are tackling medical ethics and new technology, and the question “We can do it, but should we?”. Following the presentation, I will be posing your questions to our panel, which you can post in the chat box. In a moment, I’m going to turn the program over to our moderator who put all of this together, Dr. David Snyder, Dr. Snyder is chair of the Bioethics Committee at City of Hope, and the Emeritus professor of Medicine at the Department of Hematology and Hematopoietic Cell Transplant. He is also a long-time congregant here at PJTC. I’m pleased to turn the evening over to David, who will introduce the other members of our panel.
David Snyder: Thank you for that introduction, Judy, and it’s really my pleasure to serve as a moderator for tonight’s topic. It’s certainly very germane to the overall theme of this series of symposia, and we do have a terrific panel.
I want to just kind of lay out the agenda for how we’re going to do this tonight. I’ll start by introducing our panel members, and ask each of them to give a little bit of background for themselves, and then we’ll get into sort of an introduction of the topic. I’ll set the stage, and then each of our three panelists will give a little bit of framework from their respective areas of expertise.
We will then sort of drill down to some specific examples of advances in medical technology, first dealing with genetic diagnostics and counseling, then pre-implantation embryonic cell genetic diagnostics, and finally gene therapy, and particularly CRISPR technology, which is certainly a very hot topic.
So with that, let me start by introducing our panel members. I’ll start with Rabbi Dorff, who is the Sol & Ann Dorff Distinguished Professor in Philosophy at the Ziegler School of Rabbinic studies at AJU, and the author of two excellent and very pertinent books. One is Matters of Life and Death: The Jewish Approach to Modern Medical Ethics, which is something I relied on very heavily when I was serving as chair of our Ethics Committee at City of Hope, and then also, a book called Jews and Genes: The Genetic Future and Contemporary Jewish Thought, edited with Laurie Zoloth, so very germane to this topic. So Rabbi Dorff, can you speak on that? Can you just give us a little bit of introductory comments about your background, your expertise, that you bring to the panel tonight?
Elliot Dorff: Sure. I’m a Conservative Rabbi, and I have a doctorate in philosophy from Columbia University with a dissertation in Moral Theory, and even though my dissertation had nothing to do with bioethics, in 1973, when the Supreme Court did Roe v. Wade – may it rest in peace — a friend of mine, who was a classmate of mine, who was then the Associate Hillel Director at UCLA, had put together a lunchtime panel at the medical school about abortion. And he had a priest and a doctor, and he said to me, “Can you talk about a Jewish view of abortion?” I had read one article about that, but I said, “Sure, for ten minutes.”
But then people thought I knew this stuff, and so people started asking me about this, and so I got more and more involved in issues of bioethics, and I have been on the Ethics Committee at UCLA Medical Center since the early 1980s, and I’ve been on three federal commissions having to do with health care: Hillary Clinton’s health care task force — may that also rest in peace – and the Surgeon General’s Commission to Reduce Sexually Transmitted Diseases, and NARPAT, the National Human Resources Protections Advisory Committee, a commission to try to revise the federal guidelines on research on human beings. And I’m now on the State of California’s commission guiding stem cell research within the state. And I did those two books that Dr. Snyder just mentioned. That’s enough about me, I think.
David Snyder: Okay, thank you. Ellen, now, needs no introduction to this audience from our synagogue, but for the purpose of this symposium, you can give us a little bit about your background and expertise?
Ellen Knell: Okay. I’m a geneticist PhD and a Genetic Counselor, Board Certified. And it turns out in 10th grade Biology, I loved learning about genes and the rats and mice, and all that stuff, and I haven’t changed from that. I decided I’m a biologist at heart with a lot of STEM in me. I’ve worked at various places. I did my dissertation at David Comings Lab at City of Hope on Attention Deficit Disorder, and Tourette’s syndrome. Are they genetically related? Yes, they are, which was against what was believed. And I’ve worked at Children’s Hospital, and I’ve worked at various hospitals in the area. In the last about 10 to 15 years, I’ve changed to simply doing breast cancer and other cancer as a predictive topic, so that I can help individuals figure out if they are at increased risk for particular cancers and so what to do about them. So that’s why I’m finishing my career now, and I’m still working, now at Los Robles Health Center.
David Snyder: Okay. Thank you very much. And then we have Dr. John Zaia. John is someone I’ve known for many years working at the City of Hope, and we both hail from Boston originally. John, can you give a little bit of background of what your current expertise and experience is that’s germane to these topics?
John A. Zaia: Yes. I was originally trained at a Jesuit college in Massachusetts, Holy Cross, and from there I went to Harvard Medical School, and eventually became a pediatrician.
I mention that only because of the requirement in college for all of us to minor in philosophy, which is related, I think, in some ways, to our topics tonight. But then, as a pediatrician, I had an opportunity to work at the Center for Disease Control, and became a virologist – I guess I was a pediatrician specializing in viruses anyway, but then I became a card-carrying virologist, working on vaccine development and that sort of thing, and in 1980 moving to City of Hope, because I was working on the immunity of cancer patients to viruses. And there is a particular problem with viral infections when you are getting chemotherapy, especially chicken pox, and those diseases of childhood. So here in LA, in 1980, is when AIDS appeared. And so I became more and more involved in AIDS. And I was studying a virus called cytomegalovirus, which was a particular problem in David’s patients, bone marrow transplant patients. And at that time, about one-third of all of the City of Hope bone marrow transplant patients were dying of cytomegalovirus.
So it was a combination of HIV and CMV, and working on those entities, that eventually led me to gene therapy, which uses viruses to deliver genes for correction of some problem. And from that standpoint, what we were doing was we were altering the bone marrow of AIDS patients to protect those cells against HIV. And so we actually had transplanted several patients with genetically modified cells that were protected, just to see if our cells would go into the patient and be curative. And we know that you can cure an AIDS patient if you give them enough bone marrow from a person that is genetically protected. And so that’s how I got into this whole area of gene therapy. So right now, I’m the Director of Gene Therapy at City of Hope.
David Snyder: Okay. Well, thank you very much. I mean I think, as I said, we have definitely a very well-qualified panel to help us deal with the issues in front of us tonight.
So it’s clear to everyone that we’re living through an age of technologic and informational revolution, where changes in these areas are developing at an exponential rate, and often the speed of these technological breakthroughs outpaces society’s ability to understand the implications fully, and to put in guardrails and protections that are needed. Clearly, people doing research in these areas are motivated to do good (well, we certainly hope so) for individual patients, as well as for the population and society in general.
But we always have to worry about the flip side, of unintended consequences – either unintentional side effects from drugs, off-target effects from so-called targeted therapy, and then, of course, there are people with malicious or reckless intent who want to take advantage of new technologies for evil gains, if you will. There may be well-intended researchers or scientists, physicians, who nonetheless, through their intervention trying to help people, actually have negative consequences that were unexpected.
And I’ll give one example, [which] is the story about sickle cell screening. This was something that goes back to the late 1960’s, early 1970’s. It was in Boston and other cities, and actually involved the Black Panthers. So when scientists were able to figure out how to screen for sickle-cell trait – you know, sickle cell disease, of course, is a very serious disease, I think John might talk about it more later, both in terms of morbidity and early mortality. And people may be carriers of the sickle trait, and it takes two copies of the gene to manifest as disease, as Ellen will expand on. So physicians in the Boston area at that time thought, “Oh, look, this is such a serious and difficult disease. Now we have a way to screen for it, and we’re going to offer this to the population,” which is mainly the Black population of that community, which is mainly where sickle cell resides. “And we’re going to offer this screening and help them to avoid these terrible diseases.”
Well, that was their intention. Unfortunately, the interpretation of this effort from the Black community was, “Oh! What are these mainly white, male physician scientists trying to do to us? They want to screen for this disease and tell us we shouldn’t bear children. They want to basically, you know, wipe us out, as a form of genocide, in a sense.” And that was the severe backlash from the Black community, that, you know, the physician scientists clearly had not anticipated. You could probably talk about a more current model, about mRNA vaccines for Covid, let’s say, and all of the strange political, social, and other reactions that have gone on, that no one ever really expected. So that’s certainly a concern.
But let’s talk about the two main areas – I’m not going to talk about sort of electronic technological advances. I mean, you all probably have your little device in your pocket, which, you know, says more than anything I could say about how far we’ve come (and by the way, please mute your phone if you haven’t already). And you know, that’s an area which, again, has tremendous potential for good. But there’s also the flip side, of cyber warfare, and ransomware and malware, all of that.
Now, in the genetics revolution, you know, there have been amazing advances in being able to diagnose and potentially treat a number of diseases, particularly with a genetic basis. The so-called Human Genome Project went on from October 1990 to April 2003, to sequence the entire human genome, and the thought was, “Boy, if we could only do that, then we could figure out, in every disease that has a genetic component – where is the abnormality? Is there a mutated gene or a missing gene? And if we can do that, then that could lead to intervention, and treatment, and hopefully cure.”
And we’re going to be talking about some of the ways that this has been put into practice, but also, particularly when we talk about gene therapy, what some of the concerns are for potential misuse. Stem cell technology – Rabbi mentioned that. And that’s been a huge advance there in understanding sort of the plasticity of cells, how cells that have so-called pluripotential – which can, you know, differentiate into any type of cell in the body, can be pushed into one direction or another, and even the other way around, how more committed adult cells can be pushed back into a more pluripotential state, and all of the potential benefits and uses of that kind of technology, as well as the potential for abuse, are things to be concerned about.
I’m going to give you just two fictional scenarios to sort of tweak your brain a little bit, to think about some of these dilemmas. There was a play that was in Pasadena, and then on Broadway, not too long ago, called The Twilight of the Golds. Not “the gods,” but “the Golds.” And for those who’ve seen it – I’m going to sort of describe it, and I’m going to give a little spoiler alert if you haven’t seen it and you might like to one day, so I don’t give away the ending. But basically it’s about a story about a family, the Golds. There’s a young couple. The woman is a researcher. She’s a biochemical genetics researcher, and she’s trying to isolate the quote “gay gene,” and she is actually successful, she thinks, in identifying the “gay gene.” Of course, that’s fiction – but for the purpose of this story.
Now she happens to be pregnant – and the other element is that she has a brother who is gay, and so that’s the conflict. That’s the dilemma – she has found a way to do in utero diagnosis, and to find out whether the fetus she’s carrying has the gay gene, and the question is, first, will she do the test, number one. And number two, if she does the test and finds that the fetus does have this “gay gene,” what was she going to do? There was no CRISPR available to edit it, but the only consequence would be to abort the fetus. And of course there’s all this conflict with her brother and her parents. She loves her brother – her brother, though, can’t accept or conceive that she might actually choose to abort a fetus because it has the gay gene. How could she possibly do that? So that’s the dilemma that’s put forward in the play, and here’s the spoiler alert – if you don’t want to hear how it ends, maybe put me on mute or something – but at least in this play, she decides to abort the fetus that is carrying the “gay gene.” And of course [there are] all the consequences with her brother and the rest of the family.
So as I said, that’s a fictionalized scenario, but not too far away from the truth of where we are today. Another scenario was now, with the human genome sequenced and all, people have thought about this scenario where everyone will have their human genome, their own personal genome, sequenced, and you’ll have a chip you carry – you’ll have a set of dog tags, you’ll have your genome chip. And when you go to, when man and a woman, go to City Hall to apply for marriage license, their chips will be compared, and if they both have recessive genes for a particularly devastating disease, they will not be granted a marriage license. So that’s kind of a Big Brother, 1984 kind of a scenario. But again, another version of these issues.
So with that as my introduction, I’m going to turn to our panelists, and I’m going to start with Ellen, who’s going to give us a bit of a framework of what we’re talking about when we’re talking about genes and genetic components of disease. And then we’ll go to John, to give us the basics about the gene therapy issues that he’s involved with. And then we’ll turn to Rabbi Dorff, to give us a framework from the medical ethics, and particularly the Jewish medical ethics, point of view, of how we can try to approach some of these issues.
So Ellen, why don’t you start?
Ellen Knell: Okay. I am going to start really, really basic, because I had genetics in 10th grade high school. And I’m suspecting that some of you have not had anything about it since then. So I’m just going to start at the beginning, and I do this when I see patients as well, because I never assume that someone knows something, and they want to make sure we’re on the same page.
So the gene is “the building blocks of our bodies.” And they do cellular processes on the chromosomes. And we get one of each from our father, our sperm donor, whatever it is these days. And one each from our mother or similar donor person. And so we have two of each of them, with the exception of some of the genes on the X/Y chromosome, which we’re not going to involve ourselves with now. When something goes wrong, when some of these genes are not functional, it can lead to pretty major problems with the body, which is why we’re talking about what we can now do about these in 2022, where we’re getting to new techniques. But in the past, we did not have that many choices, and one choice was, if you, as was just mentioned, about the quote-unquote “gay gene,” the only choice at that time was to abort the fetus.
Now we can do a few other things. There’s pre-implantation genetics, which is expensive, but you look at the zygote – the combination of egg and sperm in the test tube, not in the body – and you see if that is carrying a gene that you don’t want replicated, that is going to be disastrous to the fetus. And you can either abort, or choose to continue, the pregnancy.
You can also examine the cells from the fetus, which is done with amniocentesis. And if there’s a problem in the fetus at that time, if it’s not fixable, you can choose to abort or if you know that you’re carrying a disastrous gene, and your partner also has the same one, you could do things like use donated sperm. There’s at least one very religious Orthodox Jewish group in New York who only — it’s all arranged marriages in that community. And they only introduce the young people to someone who does not carry the same mutated gene that they have, just to avoid the problem of the two negative alleles getting together, and resulting in a very defective fetus.
Tay-Sachs was one of the major first ones, and that was a huge problem for Ashkenazi Jews, and then we were able to figure out who carried abnormal Tay-Sachs genes, but it was still the same choices. You either did not have children, you used donated sperm or examined the – I’m not even sure at that time that we could do amniocentesis and examine the fetus as it was developing.
Another difficult one is cystic fibrosis. And Ashkenazi Jews are at increased risk for, particularly, five difficult autosomal recessive genes. In contrast to autosomal recessive, when it’s autosomal dominant, it takes only one abnormal gene to produce an affected fetus. And sometimes these are later-life onset, but one of the ones is achondroplasia, the dwarfs you often saw in the circus. And that’s sometimes is inherited if one of the spouses is an achondroplastic dwarf. But most often it’s an accident that happens in the in the sperm or egg, and it’s not expected and not planned.
So we’ve not come, actually, that far with our handling of these risks that we have. What I do is mostly – I work with cancer now, and we have mutated genes in cancers, and I think many of you in the audience know about BRCA-1, BRCA-2.
But Myriad Labs had a patent on that until 2013, and those were the only two that could be tested for, and the price was $4,000 – $6,000. And now the price for the full panel of tests — about 90 genes that make cancer more likely — is $250, and often covered by insurance. So we’ve come a very long way from being able to identify people at increased risk for cancer, but we still have those same choices. Do we want to give birth to a child who has a 60% chance, let’s say, of having breast or ovarian cancer, and often they’re earlier than normal population times — onset can be 40 or even earlier.
We can identify these people. We can’t fix it, as most of these are later-onset adults, but we can do such things as increased surveillance, increased screening, prophylactic surgery, removing well parts that are likely to be become diseased. We now have the dilemma with the two first genes that were identified that increase breast cancer risk, BRCA-1 and BRCA-2. There is somewhere between a 40-60% chance of a carrier having breast or ovarian cancer. Now we have moderate-impact genes, where the risk, instead of 12% in the general population, might be 20% or 24%. And so there’s a range of how impactful these genes are going to be.
So if we had ways that we could repair the genes, or prevent the disease genes from being expressed, we would not have to deal the choices that we have now, and so we’ll be talking about that some more later. And that’s it.
David Snyder: Okay, thank you very much. I think it brought everyone up to speed. John, do you want to give us some basics about some of the techniques involved in gene therapy that you mentioned briefly in your introduction? And we’ll save the CRISPR for the end as the main discussion, but before that, what other techniques have you been dealing with? And particularly, I know you’ve worked with the institutions, with the NIH and the FDA. Just to give people a sense of how new technologies, new treatments, what kind of screening and regulatory guard rails are in place that you have to go through to bring a new therapy to the bedside?
John Zaia: Okay, so as I referred to, if you want to put a gene into a person’s body, because the gene of the person has already, let’s say, to make red blood cells. In sickle cell anemia, they’re missing a certain gene. You can correct them, by kind of blunt force, by putting that gene into a virus that would normally infect a bone marrow cell, it would make the red blood cells. And in doing that, you’re infected with a live virus. The virus can’t replicate, but it has the ability still to become part of the DNA. And so you kind of push this gene, the corrective gene, out, into a space in your DNA. It’s not the physiological space, it’s not the normal space, but you have now integrated into those cells those stem cells. Those stem cells can now make new cells like red blood cells and platelets. And the red blood cells now are corrected, and they can make new red blood cells.
So using this method — and I call it a crude method, it’s quite sophisticated, obviously, but the way it was done is they took an HIV virus that normally integrates into the bone marrow, and they removed any of the genes that were pathological. And the virus can’t replicate, it can’t make you have AIDS. But it’s still left with the integration function of the virus. So now with the corrective gene, the virus carries it into the cell, puts it into the DNA, integrates it there, and stays there.
So the problem is, it may have integrated into a site that normally has some other function — let’s say, function is to control the normal growth of that cell. And if you block that, I mean you, if you disturb that control, you could get unbridled growth of the cells. You get leukemia. And that’s exactly what happened in some of the early patients that were treated in this way. Things were improved, the vectors — we call these vectors — and now the current vectors are quite good. We have not had any production of leukemia or lymphoma due to the virus in this process. But in the treatment of people that have problems with their bone marrow, like people with anemia — it could be sickle cell, it could be thalassemia as well, it is a big area of interest because of the problem of managing such patients. The bone marrow itself can be diseased by many years of having to continuously produce a lot of red blood cells. It just gets to be a pathological marrow that is predisposed to having some problems. And it could be leukemia or lymphoma.
So what’s happened is there are companies that are treating sickle cell disease and thalassemia with a lentiviral vector, and they have very successfully cured these patients. But some of them have gotten leukemia or lymphoma, and so that’s what delayed the whole approval. But it’s likely that this year, the treatment of thalassemia will be approved using a lentiviral vector in the United States. It was already approved about two years ago in Europe.
But the problem with that is, in addition to potential risk of getting leukemia or lymphoma, is the cost of the treatment is approximately 2 million dollars. That is a cost that’s been generated by the companies, in consideration of what it takes to normally take care of these patients for their lifetime. If they’re going to live 40, 50, 60 years, it takes a lot of money to give them transfusions and take care of the disease. So in Europe, the treatment of thalassemia has been rejected using gene therapy, because they can’t afford it. And all of the countries basically are under governmental control in terms of what they’ll accept and what they can afford, and they say “We just can’t afford this.”
So the company is called Bluebird Bio. The value of Bluebird Bio plummeted when that occurred. It was worth billions of dollars until that moment. But Bluebird Bio hopes to get approval in the United States for the treatment of thalassemia. So that’s the book, (35:01). That’s called the crude way of doing gene therapy. But what if you could be more selective, and go exactly to the right space in the DNA? DNA is basically one long string with about 3 billion parts to it – 3 billion nucleic acid entities. And they’re in a specific order, so you can go in there specifically and correct them. So that’s what CRISPR does, and you don’t need a virus to do that. You could take the cells and just deliver the proteins, and the RNA that’s part of this assembly that we call CRISPR.
So that’s the idea. The value of CRISPR may revolutionize the ease at which you can do these procedures.
In fact, all of you, for $638, can buy a CRISPR kit. And if you’re a teacher, of course, you can use it to teach the process in your classroom, but you don’t need to.
You can actually do it in your garage if you want, using CRISPR kits to make certain changes in cells. So that’s the background. You want me to go to Crispr, or should we–?
David Snyder: Let’s come back to that, but thanks for the comments that you’ve given us so far, and we’ll return to CRISPR. I want to now turn to Rabbi Dorff and sort of shift a little bit of our focus to “How do medical ethics – and in particular Jewish medical ethics – help us approach some of the concerns that we have for, you know, the basic principle of beneficence, of doing good, and non-maelfisicance, “do no harm.” That’s sort of at the level of the individual patient and at the broader, larger level of society as a whole – if you can give us a framework for helping us with that?
Eliot Dorff: Okay. I’m going to zoom out a little bit, and then get to the cases at hand. Why Jewish medical ethics? What’s wrong with regular medical ethics? And the answer is that there’s nothing wrong with regular medical ethics. It’s just that in America, that’s based upon western liberalism. “We hold these truths to be self-evident, that all men are created equal. They’re endowed by their Creator with certain unalienable rights.” Right?
So then Jefferson cribbed that from John Locke, and so as an American – and I’m very, by the way, very proud to be an American for a whole series of reasons – even though there have been a number of bumps along the way, like slavery and anti-Semitism, but still we are the most pluralistic society that has ever existed on the face of the earth. A friend of mine who’s a priest told me that in Los Angeles Archdiocese, Mass is offered in 80 different languages. So I mean, we are really humanity together in America, and we’ve managed to live together more or less as multiple societies. But as an American, I’m an individual with rights. The classical Jewish story is Exodus Sinai. We leave Egypt not as individuals — we leave as a community. And when we get to Sinai, we don’t get a single right, we get 613 commandments. That’s the beginning of Jewish guilt. But it also, as a Catholic priest said, we really don’t know anything about guilt. They have that cornered. So I’ll just leave it for that.
But the point is that in the Jewish tradition, we are members of a community with duties, as opposed to, it in contrast to, individuals with rights. Now, sometimes rights and duties are reciprocal, so if I have a right to my jacket, then you have a duty not to steal it, right. But rights and duties are not always reciprocal. My duties to my children are different from my duties to my parents, for example. And in any case, if I get up in the morning and I’m an individual with rights, then the world owes me. But if I get up in the morning and I’m a member of a community with duties, then I owe the world.
So these two pieces, some pieces of the American ideology and the Jewish ideology, do in fact overlap — for example, the notion that law governs everybody in society, including the head of society, where there be a king or president, or something like that. The notion that each of individual is to be respected — for different reasons in the American understanding of things than the Jewish understanding of things. In the American understanding of things, because I’m a reservoir of rights, in the Jewish understanding of things, because I was created in the image of God, but in each of them, in both of these ways of looking at the world, each individual is to be respected and preserved, to the extent that we can, right? One of the things that comes out of this comparison is that in the American understanding of things, I own my own body. This is the Nancy Cruzan decision, for example, of the US Supreme Court, in 1990, right. So any adult can refuse any medical interaction. Right? This is not true for children, but it is true, for adults.
It doesn’t mean you have the right to demand any medical intervention, but you do have the right to refuse any. Whereas in the Jewish tradition, my body belongs to God. And I have my body in a fiduciary relationship with God. That is, God trusts me to take care of my body. So as a result, well, I might, in an American understanding of things, I might take advantage of some of these preventive genetic interventions, or curative genetic interventions. But I don’t have to. It’s up to me. I can choose to let my body, you know, disintegrate, basically. I mean, in the American understanding of things, I can choose to — well, I was about to say I can choose to abuse drugs or alcohol or smoke, although in California you can’t even smoke on Venice Beach. I mean, we’re way ahead of the rest of the country on that, right.
But let me give you one easier example that is more connected to me. I don’t know of any law in America that would prohibit me from eating a half a gallon of ice cream every night of the week. And I’m severely tempted to do that, and as long as I’m doing it, this might as well be Mint Chocolate Chip or Cherry Garcia. That stuff is so good! But as a Jew, I don’t have a right to do that, because that would be undermining the health of my body, and my body is not mine. It belongs to God. So I have this fiduciary obligation to take care of my body, right.
And then the other piece of this, that’s really important for our purposes, is that the Jewish tradition understands medicine as being not only a good thing, but something that every society needs to foster. So going back to the Talmud, a Jew may only live in a community in which there is a physician, because when you get sick, you need to have somebody who has expertise in medicine to help you prevent disease, and also to cure it to the extent that you human beings can. And there were a whole host of rabbis, through the Middle Ages into the modern period, who were also physicians. Maimonides is probably the most famous, but there are a lot of them. That doesn’t happen so much anymore, because, well, rabbinical school still takes more or less the same amount of time as it did long ago, but medical school takes much, much longer.
I was at a conference at the University of Virginia Medical School, and the Dean said to us, “In Mr. Jefferson’s medical school, how long do you think it took to become a doctor?” Answer: one year, because in the 1700’s, that’s all they could teach you right now. Now, it’s four years of pre-med, four years of medical school, a year of internship, usually three years of residency, all of that, right. So there are not a lot of MD Rabbis. There are some, but it’s simply because medicine has exploded in its ability to do things, and we’re just heard some of that in terms of genetics.
Now, what does that mean? That means that, to the extent that I can use any of these preventive mechanisms in order to avoid diseases, especially lethal or really serious diseases, I not only have a right to do that, but I actually have a duty to do that, and beyond that, I have a duty to make sure, again, to introduce this much more humanitarian, I’m a member of a community with duties, so we have an obligation to try to help others be healthy as well, right. I don’t live on an isolated island, I live in a community with all kinds of relationships, and duties that come from those relationships.
So I have a duty to support the ability of the community to foster the health of all of its members. Now, that duty has to be balanced against other duties of the community, like roads and bridges, and public safety and education and culture, and all kinds of other things, right. I mean, it’s not the only duty that the community has. But it is one of the duties that is inherent in terms of the way that, as a Jew, I have to understand my relationship to medicine and to preventive medicine.
I want to get to the kinds of things we’re talking about. I’m going to tell you two personal stories. Ellen mentioned Tay-Sachs, right. My wife and I have 4 children, girl, boy, girl, boy, as it happens. And my younger daughter and her husband were thinking about having children, and my son-in-law found out from his sister that she was a carrier of Tay-Sachs. So he was tested, and he was also a carrier of Tay-Sachs. So my daughter had to be tested, and this was 22 years ago, 23 years ago actually, now. So first test – inconclusive. Second test, inconclusive.
So that meant that my wife and I had to be tested. At the time I was 58, and she was 57. So we went to Cedars-Sinai to be tested, and the nurse looked at us and said: “You guys planning on having children, right?” (laughs). And I said, you know, “Been there, done that.” Okay. But we both tested negative. So my daughter and her husband have three children, all three of them are healthy, but they themselves are going to have to be tested when they get married and want to have children, because they may well, be carriers, right.
Second story — my younger son is a physician. And when he and his wife were planning on having children, they — this is, again, 20 years ago – they got tested for the Jewish genetic diseases, and got a clean bill of health. And then they had a son who has Fragile X. Fragile X was at the time — still is, as far as we understand, no more common among Jews than it is among the general population, although it is a fairly common genetic disease in the general population, and even at the time, in Israel, they did test for it. Now given the fact that testing is much cheaper, and much more available, you’re able to test for many, many more diseases with a simple swab of your cheek. Now they would have known that ahead of time, right. But they did not know that.
And so their first child is a son with Fragile X, who is now 18 years old. After he was around 13 or 14, he had to be institutionalized because the hormones were doing their thing, and he became violent, because he has the mind of a third grader, because that’s what Fragile X does. There are a lot of delays, both physical and mental. And so they did pre-implantation genetic diagnosis to see about having a second child free of the disease. And at the time, they took an ovum from my daughter-in-law and a sperm from my son and put them together in a petri dish and sent them off. There were only two places at the time, one in Detroit and one in Chicago, that had had some success in determining whether embryos were free of the disease or not. So they sent it off, I think, to the one in Chicago, and of the ten embryos, they were only sure about one of them that was free of the disease. They implanted that one, and that’s my granddaughter, who thankfully is free of the disease. She’s now 13 years old and all of that, right.
But my daughter-in-law got pregnant after that, and they aborted because they were afraid of having another Fragile X child.
And you can imagine that dealing with a Fragile X child, I’ll tell you, takes up not only a lot of time, effort, and money, but it also psychologically is really hard for their daughter, who’s had to be in therapy throughout all of this. And they worry a lot my son and daughter-in-law, they worry a lot about what’s going to happen when my grandson turns 21, and will no longer be supported by the school district in this particular facility, where he is being supported now. And it leads to all kinds of questions about inheritance and setting up trusts, medical trusts in order to take care of him after they’re no longer on this earth. And, you know, these things bring not only medical issues, but they bring all kinds of psychological and financial issues as well.
So it is the case — but I remember when they were thinking of doing preimplantation genetic diagnosis, and my son said to me, “But what does that mean about our relationship to our son? Does that mean that we have less love for him because he has Fragile X?”
And I said to him, “You have to distinguish between ‘before the fact’ and ‘after the fact,’” right. After the fact, if you have a child that has any kind of disability, you have the duty to do as much as you possibly can to enable that child to live as fruitful a life and as wonderful a life as that child can have, right. But before the fact, you have not only the right but the duty to try to prevent serious diseases. And so doing this pre-implantation genetic diagnosis in order to have a child without this genetic disease, is not saying anything about your love for – Amiel is his name, right – but rather it is a way of trying to prevent disease in the next generation. So it’s the Twilight of the Golds, except it’s not for the gay gene, for the Fragile X gene. And so there you have not a fictional situation, but an actual situation that happened to my own family. So certainly in terms of genetic testing. I’m one of – whatever – 160 rabbis or something in Southern California that has signed on to this “Add gene test now,” right – in other words, that couples thinking of having or, for that matter, individuals thinking of having children should be genetically tested so that they can prevent this, prevent genetic diseases in their offspring. It doesn’t mean they can’t have offspring, it just means that they need to take these extra precautions to make sure that that happens.
And why is that the case? I mean it’s not – why Jews are especially susceptible to these diseases? It’s because of what’s called the Founder Effect. Back in the 1700’s, Ashkenazi Jews were limited to the Pale of Settlement, which was Western Russia and Eastern Europe, and so there were a very small number of them, and they mated with each other. And so you had a lot of mating. Well, my own grandparents were first cousins. My wife says that explains a lot about me, but anyway.
And that happened a lot. And as a result, the kind of protection that you get from one generation leading to a genetic disease in the next generation by having various kinds of marriages of people who are not related to each other – that didn’t happen. And so what you got was this founder effect, where the same – these genetic diseases then got transmitted from one generation to the next. That’s the reason why Ashkenazi Jews have these “Ashkenazi Jewish diseases.” That said, that doesn’t mean that we are a diseased population. I mean, even in the case of Tay-Sachs — we’re familiar with this dysautonomia, which are by far the most prominent of the Jewish genetic diseases. It’s […] 3% in the general population. That still means that 97% of Jews do not have the Tay-Sachs gene, right. So I mean, Jews should not see themselves as a diseased population. But Jews should see themselves as requiring, both from the point of view of just American pragmatism but also on the basis of a Jewish obligation to take care of yourself and prevent disease when you can, should definitely get tested before they begin to have children.
David Snyder: Okay, Rabbi. Thank you very much for that contribution. And looking at the time, I want to give one more example to add to the rabbi’s example, and then turn to a brief discussion again about CRISPR, and then we’ll open it up for the questions from the audience.
I want to share a real case that came to us at City of Hope, to our Ethics Committee. And this is a young Jewish couple from New York who had fertility difficulties. And they went through the in vitro fertilization process, and they had a number of embryos that were collected and stored, and they were successful with the pregnancy. And unfortunately, their young daughter, at age two years old, developed leukemia, and this could be a particularly virulent form of the disease, and she really needed a bone marrow transplant as a best chance for cure.
Now, for those of you who know about transplantation, to find a donor you need to have what’s called an HLA-matched donor. These are the tissue transplantation antigens. In the old days, it used to be only a sibling would have a chance of being 100% matched with a particular patient. Now we actually can use a donor who’s only half matched, which opens the door to many more patients, but at this time it was full match or none at all.
And so the question that this young couple brought to us – this was some years ago – was, number one, technically, would it be possible to perform HLA typing on the different embryos that were frozen, and then to select. No, no, that was the first question. Was it technologically feasible to do that kind of testing? And let me add, additionally, there was a gene that increased the propensity for leukemia that the affected girl carried. So they wanted to be able to detect one of the embryos that was HLA-matched and did not carry this gene. that was the technologic question.
The more philosophical, ethical question, and this was a Jewish couple, was: Can they, or may they make a choice of an embryo on this basis? Would that be allowed? And for that issue, they turned to rabbinical counselors rather than the physicians.
From the technological point of view the answer was, yes, a single cell from an embryo can be taken out, and this type of genetic analysis can be performed on this single cell without negatively impacting the potential future development of that embryo. And so yes, an embryo could be selected for those criteria to be able to basically create a new child who potentially then could be a donor for the affected sibling. In terms of the ethical point of view, maybe I’ll turn to Rabbi Dorff. How would you counsel them about those issues? I think you’ve spoken to it.
Elliot Dorff: Hmm. Well, I mean as long as they’re planning on implanting usually – what is it? — three embryos normally, these days, when you do IVF? They’re going to have to choose among the 10 or so that they have anyway, right. And as long as they are going to have this child and raise this child fully as this child, right — in other words, they’re not just using this child for the sake of the daughter who’s affected with leukemia – that this child is going to be loved for him herself, and raised as such.
So this is not, you know, If you want to use Kantian ethics, this is not just using the child in a kind of “I/it” way, Buber, right. You’re not, you know, using it, but rather you’re going to raise the child with full respect for this child, then it seems to me that that will be fine. In other words, they may choose this — they’re going to have to choose anyway – and they may as well choose an embryo that will have a double blessing, God willing, namely, that it will save the older child, and it will also bring about a new child to their lives. So I mean, I think I think that’s fine.
Ellen Knell: There was a book on this exact topic, I think it’s called “My Sister’s Keeper.” I read it quite a few years ago, maybe 20 years. It was the exact same thing. The parents were having a child, and they only wanted the child to match the older sibling so they could save the older sibling. And there was just a lot of debate and understanding: is it ethical? Is it fair to the older one? Et cetera.
David Snyder: Actually that was the case, at City of Hope – John Zaia probably remembers – that there was a young girl, about 16, I think, who had a form of leukemia, and she needed a transplant, and she had one sibling who was not a match for her. And the parents — the father had had a vasectomy, and they searched, I think, also for unrelated donors, and couldn’t find anyone that matched. And so the parents made the decision to try to reverse the vasectomy, which I think is only about 10% successful, in order to try to create another child, hoping that the new child would be HLA-matched with their affected daughter, and that that new child could then be used as the donor. And she said it did turn out that reversal of the vasectomy was successful. They had a new baby, and they did in utero testing before birth. They knew that the baby, that the fetus, at the time, was, in fact, HLA-matched. And the baby was born, and ultimately was the donor for her older sister. And you know, it was a wonderful story.
Now, as the Ethics Committee, we received all kinds of unsolicited flak from all over the country. But to a particular religious viewpoint, I might add, not Jewish, who said: “This is absolutely unacceptable,” one question is, well: “What if they did the testing in utero and found it was not an HLA match? Were they going to abort that fetus?” That was one, and the second was – Rabbi alluded to this – were they only creating this child in order to be a vessel, to be a donor child for their other daughter? And how could how could you possibly allow that to happen? But I think the Rabbi spoke to that issue, and it was a very happy ending for all involved. I know that now this then-16-year-old girl is an adult, and has sort of dedicated her life to helping others to be the match in bone marrow transplant programs, and her younger sibling, who was a donor, has also devoted her life to this kind of a field. So it was really a wonderful story altogether.
Well, in the remaining time before we go to some questions, I just wanted to tee up the issue again about gene therapy. And you’ve heard terms like “precision medicine,” and “personalized medicine,” and we’ve been talking about the ability to sequence genes and in people with certain genetically related diseases, to know exactly what the mutation is that’s affecting or causing their, say, their cancer or their hemoglobinopathy.
And then, you know, that opens the door to designing therapies, whether inhibitory therapies or replacement therapies, to target that specific defect. And it seems like the ideal way of treating people: you would avoid all the side effects, the unintended side effects, of, you know, injury to other tissues, but that’s an oversimplification certainly, of of what the risks are.
I did work for many years with something called ribozymes, and then DNA-zymes, which are sort of molecular scissors, where you just in the lab you synthesize a sequence of RNA or DNA that targets the the abnormal, the mutated, gene, and if you have a way of delivering that to the cells in the test tube or to the body of the patient to attack that mutated gene and cut it out, and thereby wipe out the leukemia – well, we’ve come a long way and that’s where we are now, with CRISPR. And you know, it opens all kinds of potential therapeutics. And I’m going to ask John to return to speak about that a little bit.
The concerns are that this is such a powerful tool that, you know, are we at risk of, quote, “Playing God?” We have the ability, essentially, to remove a mutation, an error. And who decides what is an acceptable target? You know, cancer – okay. Hemoglobinopathies, degenerative neurologic diseases – but what about other features? A “gay gene,” if there was such a thing? Intelligence? Height? You name it. Now you get into eugenics, and you know that’s a slippery slope. But John, why don’t you, if you want to sort of take us towards the question here, and give us some of your thoughts about the potential for CRISPR therapy, and some of your concerns?
John Snyder: So the beauty of CRISPR therapy is that it is simple. In fact, it’s just chemicals. There are no cells necessarily involved in the actual reaction. And when Jennifer Doudna, who’s a Professor at Berkeley, shared the Nobel Prize with that Emmanuelle Charpentier, in 2020, she got the Nobel Prize for Chemistry. It wasn’t for physiology and medicine. It was for chemistry. This chemistry can be applied in many areas. It could be applied to control of insects, for control of a production of new plants – if you want short corn, new corn that’s shortened so it’s 6 foot tall instead of 9 foot tall, but much easier to harvest. You could make that with CRISPR. You could take pets and have designer pets made. Now you could do it so simply. I think that’s an interesting ethical dilemma of there as well.
But can you do it with the embryo, prenatally? Well, everyone says, “No, we’re not ready to do that. We don’t know what the effects of this could be. Could there be what would they call off target effects – that is, you hit the target, but you also have something off-target?” It could affect brain development, or whatever. So we don’t know enough. So all the distinguished groups, and I’m sure Rabbi Dorff has been part of some of these groups, have advised and made regulations, etc., etc. And most countries do not allow therapeutic use of CRISPR for prenatal, but that’s the issue, because somebody did.
A Chinese scientist was concerned with HIV-positive mothers who are pregnant. When they have their baby, the baby is not affected until the HIV infects it. [The HIV] can infect it through breastmilk and that sort of thing. You can protect these babies from exposure during pregnancy, during delivery, but after that, they’re home and they may catch it from the mother, who knows. So he said, “I’m going to use CRISPR to knock out the gene that HIV uses to infect.” It’s called CCR-5. That’s what we use in some of our trials as well.
But he used it in the IVF process, and two babies were born, and it caused a great concern worldwide. The person myself, his name was He, was disciplined by Chinese government and just kind of disappeared, but NSF put in a set of guidelines, at least, for not doing any of this or work until we have more experience with CRISPR. And we’re getting that experience. There’s a company called Vertex that’s announced that they’ve treated about 50 patients that have thalassemia with CRISPR, and they’ve had outstanding results. Something like 49 out of 50 are cured. There are other companies using CRISPR for other things like organ transplantation.
You can knock out the foreignness when you put an organ into a person. You reject it because it looks foreign. You can use CRISPR to knock out the “foreign” gene, it’s called, and have a better take of the organ transplant. There’s a great potential in a number of areas not just curative areas, but of making better organ function.
There’s also an issue called gene drive. Gene drive is the ability of certain genes to allow an organism to predominate in terms of reproduction, and you can knock that out, or you can alter it – you can turn it on with CRISPR, or knock it out with CRISPR, and you can, for example, take mosquitoes that cannot produce, that cannot support malaria, and with this alteration of gene drive, make that mosquito dominate in the population. So now you have a population mosquitoes that cannot transmit malaria, and that’s an area that’s being very actively developed.
The question is: but what happens then? What if a gene that does something else is dominating, and spreads better than the others? There’s the unanticipated consequences I mentioned that we don’t know about. And that’s the concern, I think, that many of the scientists have about some of these applications. But you can apply this within basically so many areas.
Ellen Knell: It’s the point of view of the genetic council! There’s a concern that it is going to be applied selectively, so that those who are richer, who live in bigger towns, those who are better educated, etc. will have access to it, and the poorer people, the rural people, the less educated, will not have equal access.
David Snyder: That’s the ethical principle of justice, of the equitable allotment of a limited or scarce resource in an equitable way. Rabbi Dorff, would you like to add any comments to this discussion?
Elliot Dorff: Well, I mean, I think two of the really important issues have just been mentioned. Namely, on the one hand – well, let me do the second one first. The issue of justice is really all over this stuff, right, namely that because this is new therapy, and it’s often very costly, it only really is going to be available in a capitalist country like our own, to those who can afford it. It may be different in those countries with socialized medicine. And so some of the questions that we’re asking now about the justice issues may fare differently in a place like Canada than it does in the United States, precisely because of this issue, although I must say that my wife, a long time ago, took a trip to Scandinavia and our guide was a British woman who had married a Norwegian Man, and along the way I was talking to her about these issues, and she pointed out to me that in European countries, it’s really a two-tier medical system. There’s the socialized medicine for everybody, and then the richer people get insurance for other things that are not covered by the national insurance. Canada has a law against that, that you’re not allowed to get insurance beyond what the Canadian Government provides. But all that means is that people who are wealthy come over the border to the United States in order to get their knee replacement within six months, as opposed to six years, that kind of thing, right. So I mean that’s the reason, to a certain extent, why that can work in Canada.
But the issues of justice are things that we are really struggling with, and then the other issue is the eugenics issue, right. Namely, it’s one thing when we’re talking about curing genes for leukemia, or Fragile X, or Tay-Sachs, or whatever, right. It’s quite another thing when you’re talking about, you know, trying to create a designer child, whatever that is, based upon whatever you think is the “most valuable” kind of child to have. And by the way, if you were doing that, say, in the early 1900’s the designer child would be somebody who is really good at working in the farm, because the vast majority of us in the America were working on farms, right. 100-some years later, the designer child is somebody who’s good at technology. And all of that is — that’s the piece of it that’s really very worrisome. And as a matter of fact, in the book, if I may one more time, Jews and Genes: The Genetic Future in Contemporary Jewish Thought, there’s an entire section on “What do you mean by – what’s the difference between therapy and enhancement?” right. In other words, when do these kinds of interventions really act in a therapeutic way and when, on the other hand, do they act for enhancement?
Some enhancements we have no trouble with. I mean, these [glasses] are an enhancement for my sight, right? And yet, I don’t think anybody really cares that a lot of us have glasses. But what happens with other kinds of enhancements? And when are they kosher, as it were, and when are they not? So that’s one of the things. There are a whole variety of different people who respond to that question in that book, in a variety of different ways. But that’s the other issue. The other issue is that when we’re curing diseases, especially in these diseases. But then what happens — are you going to do the same thing for people for children who would be deaf or blind, right? Who are short or too tall, right? I mean, where does the line exist as to what is therapy as opposed to what is enhancement?
David Snyder: Okay. Well, thank you Rabbi, and our other panelists, Ellen and John. We’re going to have a few questions, and maybe Judy can guide us to those questions. But I just want to say that I hope the people listening maybe get some comfort from the fact that that these questions are being raised by esteemed ethicists, such as Rabbi Dorff, but also by scientists who are involved in the actual field of developing these new techniques, and in physicians applying them, whether it’s at a local level, physician-patient relationship, one-on-one, or the national or even international level. And of course there are going to be outliers and sort of rebels who are going further than anybody else feels it’s really appropriate or safe. But they stand out, like that Chinese scientist, internationally. And I think there’s a great sensitivity to the inherent risks involved with these kinds of new technologies.
But, Judy, do you want to, with the limited time we have, do you want to pick out a few questions?
Judy Callahan: Yeah, so we’ll start with an easy one. We talked about the Ashkenazi community. Are there diseases prevalent in the Sephardic community that you know, is there a Tay-Sachs, in the Sephardic population?
Elliot Dorff: There are some genetic diseases that are more common in the Sephardic community than in the general population.
But first of all there are many fewer of them, and it’s in part because Jews, the Sephardic community, lived among Muslims, and the Muslims, by and large, treated Jews much better than the Christians did in the Middle Ages, and into the modern period. And I mean, it wasn’t wonderful, and a number of Muslim nations varied a lot, from those that for the persecuted Jews to – but the vast majority did not. For the vast majority, we were people of the book, we were Dhimmi, so we were second-class citizens. We were not really Muslim, we had not seen the light and believed in Mohammed, but we did not have to be forcefully converted either, the way that everybody else did, except for Jews and Christians. And in some Muslim – I would say, in many Muslim communities, Jews were not ghettoized, and they were allowed to be part of the general community in all kinds of ways.
And with that meant was that you had Jews off well, literally in the Muslim world from Morocco to Iran, who lived in communities that were much more open and diverse than what happened in Ashkenazi communities. So yes, there are some Sephardic genetic diseases, but they are much rarer. And people from Ashkenazic, I mean, from Sephardic communities or from Persian communities really need to be tested also, especially because it’s so easy now.
Judy Callahan: So, Rabbi, you began to touch on this, and I know, David, you’re also on ethics committees – the line between therapies and human experimentation. How do we delineate that? Is there a beginning to delineate it, aside from the eugenics question, just at what point do we become guinea pigs?
David Snyder: Well, I’ll speak to that. I think, John Zaia can kind of probably speak to it, and Rabbi Dorff – you know, there’s a very formalized process in place starting at each institution has what’s called an IRB, Institutional Review Board, that’s charged with protecting the rights of individual patients in the context of medical treatments. And there’s a very multi-step process, that John is very familiar with, in taking, say, a new drug, whether it’s a genetic-based treatment or another type of a compound that you want a patient to ingest, to go from discovering the potential value of that in the test tube or in an animal model to getting it into humans, into patients, it takes many, many steps, regulations through the FDA and the NIH, and many years. Some might argue that it’s too many years of delay. So these new treatments have to be clearly identified as investigational – if you will, experimental. And patients have to be informed fully and given informed consent about the risks and benefits of the treatment, the risks and benefits and alternatives. It’s a very involved process. John, do you want to speak to that?
John Zaia: All of the activities that we hear about right now — about CRISPR, for example – none of it’s been approved in the United States as research. So, are you a guinea pig? No, you’re actually a humanitarian. And that’s what we tell the people, that they actually are giving a gift to our society in participating in these current research experiments. They are experiments, though. And we say that right in that consent form. You will not likely benefit from this, because we don’t know what the outcome is going to be.
David Snyder: Rabbi, do you want to add anything?
Elliot Dorff: Yeah, I mean, I was on the National Human Resources Advisory Commission back in 2000 to 2002, reviewing and revising the Federal guidelines on research on human beings. This was after Jesse Gelsinger, a young man, had died of an experiment at the University of Pennsylvania, and Ellen Roche, a young woman of 24, who had died of an experiment at Johns Hopkins. And so the question was: should what’s called the common rule, that’s shared by 19 different agencies of the Federal Government – whether it should be revised or not, and in what ways?
And while I was on that commission — now, this will either be comforting to you or not – I found out that every single drug that’s used for children is really just an a a drug that was approved for adults, and then pediatricians figured out what the dosage would be, because no drug company wants to take the liability of experimenting on children. Same sort of thing with pregnant women, right, that the drugs dealing with pregnant women are really approved for adults generally, and gynecologists and obstetricians do what they can to try to figure out whether they’re safe for people, for women, who are pregnant. And a lot of it is a question of experience and double-blind studies and things like that. So this kind of issue, which raises all kinds of very important questions about respect for persons and what is informed consent, and how does, and what level of risk is involved, and to what extent does the patient know it when undertaking that risk? And to what extent is it really consent? I mean, if your sergeant tells you — you’re a private in the army, your sergeant tells you “you’re going to be part of this experimental therapy,” right, is that consent? Or if you’re in jail, and you have a sense that if you volunteer for this experiment then you’ll get out of jail faster, is that really consent — even though you’re told that it’s not going to have anything to do with your prison sentence, but you think that it will? Is that really consent?
So all of these kinds of moral questions about human experimentation come to the fore in these kinds of new technologies. On the other hand, if we don’t do experiments on human beings, then we’ll never know whether they’re safe, and then everybody’s a guinea pig, right. And that’s what the IRB system is all about, right.
There needs to be a system whereby we maximize the amount of knowledge and consent involved in the experiments and minimize the risks of the people involved to the extent that we can, knowing that some of these are going to go awry. I mean, that’s the nature of an unproved intervention.
David Snyder: That’s a dilemma, when I was doing bone marrow transplants, that we had all the time. We would have our patient with the disease – say, leukemia – that without appropriate treatment was going to be fatal, and we’d come to them, and we’d say, “We have a treatment, a bone marrow transplant that has high likelihood, of being curative, but it’s not 100%, and these are all of the different complications that could potentially occur.”
Well, once we said the word, that “this is a potential cure,” the patient’s mind is closed. They don’t hear all that comes afterwards. And then, unfortunately, later on, they get through the transplant, all the difficulties, they get through it, and then they develop some very serious complications. They say, “Hey! No one ever told us that this could happen. I didn’t think it would ever be like this.” So, as you said, the issue of what is truly informing a patient, and what’s informed consent — it can be very challenging.
Okay, Judy. Any other questions?
Judy Callahan: Yes, so I think this will be our last question. But it’s an interesting one.“Because we can now tell so much genetically in the neonatal stages of life – someone pointed out children’s dentists were being pressured to report to insurance companies if they could detect that there would be future problems, so that pre-existing conditions, so that insurance companies would be off the hook for treating children who perhaps in utero, you could tell he had a chance of developing certain diseases. Where does the line draw about how we handle that, and how that information is shared?”
David Snyder: That’s a tough issue, and a real concern, that getting this genetic diagnostic information could be misused, and potentially employment issues, but moreso, as you said, insurance and pre-existing conditions. Ellen, is that something you deal with in your practice?
Ellen Knell: Oh, absolutely! None of the patients I see — my reports do not go into the medical file. It’s sort of – I guess it’s legal. I was told that this is perfectly fine to do, but the medical file does not — it might say they had genetic testing for cancer gene search, for whatever panel, for whatever it was I was looking at. But the result is kept in a separate locked file. You’re not allowed to discriminate, insurance companies are not allowed to discriminate, on the basis of positive genetic testing. You’re not allowed to lose your job over that. There’s no such provision for things like life insurance and disability insurance. So, if you get a positive genetic test that you were very likely to have a particular genetically – I’m thinking of cancer at the moment — they are allowed to discriminate based on that on disability and life insurance but not medical insurance. And I’m fortunate that I can keep it out from the medical record.
David Snyder: That’s the current state of affairs, which doesn’t seem quite fair. But that’s the way it is right now.
Elliot Dorff: Even the protecting people in terms of medical insurance is just, as a result of HIPAA right, which was 1999 or something — at the end of the Clinton administration. Right? So even that is rather new.
David Snyder: So I I think we’ve run out of time. Judy, do you want to close out the session?
Judy Callahan: I just want to thank our panel for a really interesting discussion, that I think has answered many questions, and brought up many others for continued debate, which is part of what we hope to Sinai and Synapses series does. We want to thank everyone who joined us this evening for engaging in this program. You should know that this will be posted on the PJTC Youtube site, if you know people who are not able to tune in tonight, and also it will be on the Sinai and Synapses site.
And again, you can go to sinaiandsynapses.org. When you visit their site, you can sign up, they have weekly updates, and they have fascinating other discussions.
Bonnie Buratti, one of our congregants has an article posted right now on their site, so I strongly urge you to go see it.
Our next program, by the way, is going to be on March 15th, a Sunday morning, and it’s going to be – Dr. Christine Garroway is going to be looking at what we know from Torah, and what we know from archaeology, and where they overlap, and where they don’t quite overlap. So that should be really interesting. And her field of study is especially looking at children in the Middle East, and so to give you a teaser, being a child in the ancient world, was not necessarily all fun and games.
So we strongly suggest that you tune in to Dr. Christine Garroway, who will be talking on March 15th. Again, thank you so much to everyone on the panel and thank you to everyone who joined us.