What promise do stem cells hold for the treatment of medical conditions? In this five-part online course you will explore the history and basic biology of stem cells, learn about new research techniques, and find out how stem cells could lead to cures for diseases and to individualized medicine. You will hear from Museum scientists, medical researchers at the frontiers of the field, and a panel of bioethics experts who will address the ethical implications of stem cell research and therapy. Learn what has already been accomplished, what challenges remain, and what medical breakthroughs may lie ahead.
The Bioethics of Stem Cell Research and Therapy: Part Two
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From the course by American Museum of Natural History
The Science of Stem Cells
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From the lesson
The Bioethics of Stem Cell Research and Therapy
To complete the course, a panel of bioethics experts will discuss some of the controversies surrounding human embryonic stem cells and the legal, policy, and ethical challenges associated with the use of stem cells in basic and clinical research. You will have an opportunity to discuss and ask questions about the future of reproductive technology and stem cell research.
Meet the Instructors
Dr. Zehra DincerCourse Instructor
I think it's a great time to open and get questions from our audience.
And we will have a microphone on the back of the room so you can
say hi to Emily and she will come close to you.
One of our speakers talked about how a lot of
the embryos are created would not necessarily be viable if implanted.
And if that's the case, what's the ethical issue there,
if you know that it's not going to become a person,
or it's not going to have the potential to be a person,
what's the ethical consideration about using those stem cells?
So, one of the tricks is that we still aren't very good at knowing
which embryos are going to be able to become a baby and which are not.
So, they're trying really hard for
reasons unrelated to stem cell research to get better at
predicting that embryo is likely to keep going and that one isn't.
Because there it's the holy grail for IVF treatment, right?
Right.
Now, I think, if we knew, and sometimes they do,
because they have abnormal embryos that are patently
abnormal like they have three per nuclei or something,
so they can look at it and say that one could never.
It's not like we can't, even though that we genuinely aren't very good at it.
So, if it really is not going to,
then those have been used in research.
But they could still not be federally funded though.
No, you couldn't. That's true. That's true.
And thats the whole thing, because even if you had what could be a viable embryo,
it wouldn't, for policy purposes,
it still wouldn't matter.
It would be the lack of regulation
about just clinical destruction of them would still be allowed,
but destruction of them for the purpose of
research using federal funds would still not be allowed.
It's kind of like why you should be really
careful who you ask to write legislation right.
Because the legislation is like, literally,
you can go home and google as you will see
the words and they don't say things like "At least they are non-viable human embryos".
Nowhere near that nuance.
That's the kind of nuance you can get and throw
regulations or oversight by a statutory authority or something like that,
but it's not going to be in the legislation.
The legislation is such a blunt tool that it
doesn't make some sort of distinction between research on viable, non-viable embryos.
Even though people have totally made the argument,
you see those are really different things.
And I think the issue is let's say a couple makes several embryo, like eight embryos.
The physicians usually look for the one and you are only going to implant one or two.
You look for the healthiest,
the ones that will look best.
Usually just looking under the microscope it would see best formed.
In which are meeting they are like,
you know, by day two they should be these many cells.
So there are ways of grading embryos.
It's not as if it's completely random.
It's just that even with those grading systems,
it's still the case that about 30 percent
of the embryos that are transferred lead to a healthy birth and the restart.
So, we still aren't really good at knowing the difference.
Just an additional aspect of that question,
there are segments in the population who
would answer you by saying viability has nothing whatsoever to do with this.
That once conception occurs,
once you have a zygote,
once you have a sperm and an oocyte combine,
that is a person.
And therefore, those embryos are entitled to be
treated with the dignity with which you would treat a person.
And that argument has nothing
whatsoever to do with viability and that argument is out there.
It's part of Roe v. Wade and it's sort of the big question that's been
dancing around for the last hour and
a half that's still out there that will need to be addressed.
So, while I think that you might find
an over-representation of people that think that in positions of an elected office,
that is not the position of the majority of people surveyed in public opinion polls.
So, there's a big disconnect, right?
So, the way that this issue was sort of
presented in the public conversation in
America is like you either think it's a person or you think it nothing.
Just like people say,
"Wow you're either completely pro-life or completely pro-choice."
And most people actually are somewhere in the middle,
and that is not captured appropriately by policy,
by regulation, even by public discussion.
I think it's poorly discussed.
It's poorly understood that
most people are somewhere in the middle on all of these questions.
I would just say it's one of the reasons that
informed consent is important, in other words,
so that if the man and woman who create the embryos say,
"Well I understand that people say,
but I think I'd like to donate this for research."
That gets around some of the obstacle.
And is also the case that there are people who do IVF who
do not want the embryos to go to research and that we have to respect.
I think like that is not stupid.
That is not ridiculous.
I don't even think it's irrational.
I think it's something that we need to respect
people's beliefs and they choose things like donating to another infertile person.
They might think that's actually like a wonderful thing for them to do.
Some people choose to just be given the embryo and to have it basically perish.
So, people do different things and have really different approaches,
and it seems important at least in a kind of
clinical ethics perspective to respect that people have.
Usually, people who've gone through IVF,
like it's all very well to be like,
"This is how I would think about if it was me" that if you actually do it,
people have a variety of experiences and some people
surprise themselves by what they decide to do. Right?
And I think that when we sort of just look at we've created an embryo,
how do we feel about the embryo is one thing,
but when faced with the question of this embryo is frozen embryos,
these left over clinically accessed frozen embryos
that the couple does not want for whatever reason.
Would we be happier letting it just be
destroyed or be destroyed for the purposes of research?
And so while we talk a lot about it,
and I think it is a valuable discussion,
my master's thesis involved large portions of how do we classify the embryo,
one of the bigger policy questions is we have the left over embryos
and what should we be doing with them.
Some people do choose research for their leftover embryos,
but that's a big category too.
That's not just embryonic stem cell research.
I mean there's infertility treatment research that
uses embryos to try to improve infertility treatment and a lot
of people who go through IVF might feel like that's the kind of
research they want their embryos to help other people.
So, even within that category of donating to research,
embryonic stem cell research is one kind of research that you might donate to.
And the problem also is,
as we talked earlier, a lot of couples are sort of ambivalent.
They have used, there are so many embryos,
they have so many left,
and well maybe we'll use them some day or maybe whatever.
And so rather than say, "You know what, I'm done now.
Just give them to research."
Often, it's a complicated question and it's
obviously wrapped up with a lot of issues of meaning and emotion.
And so people don't like to think it through all the time, understandably.
Yeah, that's right. I do think we need to be
quite compassionate towards people who think first it's-
And even if they don't want to think that they're alive,
that's something that I think we can all respect.
I can imagine being somebody
who is like completely pro-choice but
still feels funny about what to do with the embryos.
I think that's a perfectly understandable situation.
I would just say one more thing. To me,
I think embryos have some moral status and I would argue,
not only getting this whole debate,
but that the issue is not just let's destroy embryos for the sake of destroying it.
The issue is if we can come up with treatments that are going to
save large numbers of people.
It's weighing.
It's not just let's just destroy embryos for the sake of destroying it.
Do you know if there's a time limit of freezing embryos?
Is there a point where then it won't be even useful for research at all?
We don't know.
We don't know.
Which is just to say no, not yet.
So, you mentioned earlier the importance of
knowing who is writing the legislation for these things.
I'm a little surprised to hear that germ line was included on a writer from Congress.
Who wrote germ line? I mean,
I'm surprised to hear that they know those words.
I see.
So, who is writing that?
So, they didn't write germ line.
I think we're actually more responding to the announcement in 2015 of CRISPR.
So, they were anticipating,
not so much mitochondrial replacement technology,
which is a kind of intervention that results in a germ line change,
isn't a heritable change, at least.
They were more thinking about changing the genes of people generally.
So, the legislation is written in such a way that it talks about,
I'm going to get the language a little wrong,
basically like any application for research that
would introduce a heritable change into an embryo.
So that captures mitochondrial replacement technology.
It's not yet. Well, it's not.
So, that's what they knew about more of the mitochondria.
They were thinking about gene editing which was enormously in the news in 2015.
So, they were never in conversation-
Well, now they did have hearings in Congress, right?
I don't know.
So I follow this stuff and I was like, "They did what?"
I felt taken a little kind of like taken by surprise.
I can't tell you who sponsored.
It was not like a boat so it didn't get sponsored,
so I don't know who put that in.
It came out of a committee so I'm not sure who it was,
and I haven't tried to figure that out.
I don't actually know entirely how to figure that
out in the U.S. because I was in a subcommittee,
I think, so our committee, I don't know if it's even public record like who-
I think it's known.
Probably. And someone knows who did.
It's not completely transparent. That's for sure, yeah.
Just shifting gears a little bit.
I'm curious about the ethics around the chimera issues that the idea
not necessarily the embryonic stem cells but just growing hearts and pigs.
What are some of the ethical questions or
any guidelines around that kind of work?
As you say, there's tremendous potential in quote,
chimeras and their hybrids and different sort of mixing of cells from different species,
so this is going on in animals.
The question is whether to involve human cells and human embryonic cells.
Their degradation's of how much concern people have perverse reason and certainly,
for instance, we wouldn't want mice or
chimps running around with human brain cells in them, that would be-
We definitely have mice with human brain cells. Absolutely.
Yeah. But may be they are not running.
But not that are through reproductive tissue?
No.
In other words you wouldn't want mice reproducing that
have some would be able to sort of produce partly human brains.
In other words one issue is,
is it going to be affecting future generations of mice?
And the other is, there is more of
a concern about using primates because you're closer to us.
And I think there's sort of a yuck feeling.
So in ethics, there is sometimes the notion
of some ethical issues get a sense of sort of moral disgust.
And there are those, there was Leon Kass was a head of Bush's
bioethics commission's who said that should be the basis of ethical decision making.
Some ethical decisions making.
Some ethical decision making.
Just to be fair.
Some of us disagree with that.
Would you think historically people have said sex before marriage?
Yuck. Homosexuality? Yuck. People of different races getting married?
Yuck. So the problem is that there are things we say
yuck based on cultural issues in the past,
and we now realize that was not fought through ethical response.
I would argue one needs to be careful.
We have yuck responses to various things,
but I would argue one needs to think carefully.
Maybe it's just because it's not familiar to me rather than it's being somehow wrong,
so one needs to think these things.
Some chimera research raises these issues but
it really depends on what cells going where,
from what species, into what species, et cetera.
Yeah. I completely agree.
And to build on that,
there's two predominant groups guidelines
that have dominated the conversation for the last number of years.
One comes from the NIS and one is ISSCR which is the international ones.
And the guidelines on chimeras which actually New York State also followed,
some of it I think I agree is the yuck factor.
Other parts of what we think are okay,
we think are okay or not okay when introducing human cells into
animals in part has to do with how much we are potentially humanizing the animal.
Now, for whatever reason maybe it's religious,
maybe it's fear that certain animals that we think don't
feel too much pain may feel more pain if they had more advanced cells in them.
So, there are many more restrictions on human introduction
of human cells into primates and what parts of a primate,
like the brain spinal, neural.
And one of the other general prohibitions has to do with whether or not you
have two primary animals that have
human chimera cells that could potentially be mated to each other,
so that if there was any potential that the human cells in
the animal form gametes and that you mated them,
who knows what that could create.
That's actually another one of the chimera principles.
If you're interested I would encourage you to look at
the ISSCR guidelines or even NYSTEM,
the ethics committee of New York State.
They had had long discussions on this as well.
It's really in my view.
I under theorized in
poorly guidelined area of scientific research and it hasn't become a big problem
yet because the efficiency of the transplant of human cells into even embryonic mice,
the efficiency is being really low.
So we haven't really had to deal with it in a big way
but I feel like it is one of the biggest areas under explored,
under theorized, under examined,
and the guideline areas.
So I sit on a stem cell committee and we get these chimera questions and
we find ourselves with almost nothing to help
us figure out what even matters in this scenario.
We ask questions like,
"Do you think any of these human cells will go to the brain of the animal?"
And they say, "No." "Well, I,
oh, it's fine probably then."
Like, "Why?" "I don't really know."
Or they say, "Yes" and we're like, "Oh,
how much percentage are you thinking the brain would become human neurons?"
And they're like, "10 percent."
" Well, oh, that's probably gone." Like, "Why?" "I don't know."
And then they said it based on
previous studies because actually it's been really hard to get.
But you know some studies are like trying to get
lots of human neurons cells in the brain of the mouse.
That's the whole point of the study.
And then we're like, "Well, would that be okay?"
"I don't know. Well, it depends."
Like I think it's-
And what is the why?
Why might that be okay or not okay?
What are we worried about? I think there are things,
I have my own views about it,
but I feel like as a general thing, the conversation,
the academic discussion of it,
the professional discussion, the guidelines around that are all just type of thing.
Yeah.
It's really an underdeveloped thing.
They're statements but we can all try to figure out why they're there.
They may be defensible but when you're actually faced with here's is the protocol,
why are we worried that they're maybe
And why do we worry about [inaudible].
We're worried about the pain and we're worried about the dehumanization,
like what is the why behind.
And maybe there's many why's but now this conversation has not happened.
I think it's a rich area that has not yet received enough attention.
And probably another issue with it is that the NIH about a year and a half
ago decided to lift a ban on responding research in this area.
They got 22,000 comments in response.
It's a huge amount of comments for
Federal proposed legislation and it's just nothing's happened.
I think Congress still bans introduction of human cells unto animals,
no into reproductive or into the brain.
There are certain guidelines on it and NIH
suggested lifting that and it's not been lifted.
Not to it to be done in that area.
So as you all talked about a lot of
where the legality issues come into play with funding,
so federal funding for things being dictated by.
And you mentioned that a lot of times states will then take it upon
themselves but private enterprise
also will I assume begin as we see more and
more especially as the technology gets better take it upon themselves.
So with stem cell research, with chimera,
even with CRISPR and germline modifications, other than funding,
what is the legality and where with that legality come from to
say you in your office building can't take embryos,
make a CRISPR modification and what that into the evolutionary gene pool?
So the FDA would have a lot of
oversight one to actually planning to do something with a person, right?
Is she going to put something in a human either it's cells or embryos?
Right now, this is all basic research not doing trials in humans.
Once you want to do a trial and human you need to go through the FDA and then you get,
then the FDA would have some oversight.
Now, the FDA doesn't have a whole lot of
rules about some of the things we've been talking about
but even private industry
would have to go through the FDA if they were
developing something that they were going to offer as a treatment.
And that's actually the hook.
The FDA jurisdiction and I study it and I couldn't explain it.
And it's changing now.
Yes exactly.
If Lego geek's can spend a long time looking at-
It's actually very hard where the only place would might come in is the FDA
and the FDA generally will look at things that are
being developed for the purposes of ultimate approval for market.
It will not generally look at things that are the practice of medicine which is what were
talking about before even when things are not, they are sort of novel.
So it's like a new surgical technique,
it doesn't go through the FDA whether it's a device or a drug it does.
So, what would stem cell products be
is and that the FDA has asserted authority, right, in stem cell.
Some. Part of the reason why we have this proliferation
which we didn't really discuss today are these for
profit stem cell clinics that advertise.
We're talking about you put some stem cells on your face and your wrinkles
will go away and if you take out your fat and you do this.
Part of the problem is that there's actually
no agency that can actually regulate it given their current jurisdiction,
and so there are a lot of problems as
to some of the more unethical practices
going on in stem cell therapies, stem cell clinics.
Now, if it crosses state lines,
then you've got a hook.
It ends up being some of the really dorky stuff but some of this is very complex
because even if there's a public concern about it and certainly with the for profit,
stem cells clinics, there's a huge concern.
But part of the problem is how do we
stop it given the way the government works and where the jurisdiction is.
Because if you were saying during mitochondrion placement,
no one's really in power to come knock on your door and.
And you're not going to jail
for that if you sort of got around all the fund, Is that assessment?
Taking an embryo and changing it and putting it back in someone's body,
the FDA has asserted authority over that.
Now, you can't look at it because of this law.
As soon as you deal with a human being, it gets looked at.
I think, on the other hand,
though just in terms of research and labs,
which I think you're asking a little bit about,
we have intellectual freedom here.
So, as a researcher in the university,
there are many things the law doesn't say you can't study certain areas by and large,
but funding is sort of separated off as one of the levers that the FDA in terms of uses.
I would say the other area that the reason
the FDA is changing on this is because there is becoming
a whole area of potential treatments that are biologics, right?
We're now going to be giving gene therapy,
which no longer a medication, a chemical compound,
but there are other kinds of things we can give that may
help treat a disease that are more
just biological things and there are a lot of questions
about what should the approval process be for those?
Should it that be different? Should it be individualized?
That's the 21st Century Cures Act addresses some issues with biologic.
But this is a rapidly changing area because, again,
the technology is advancing,
and we're trying to figure out how we should regulate these things.
And even though it might be good for those small clinics,
that there isn't really clarity about some of the regulation,
it's not good for the larger players in the industry,
as a general rule.
Not knowing what exactly the regulatory pitcher is,
is really bad for companies, for industry,
because any uncertainty like that basically makes
people not want to do that work or not want to pursue that
because they don't know exactly how it's going to come out and do some regulation.
Or those who could figure out that there is no regulation,
then very much take advantage of the fact that there is no regulation.
How much can they profit? How much can they-
The big players in the pharmaceutical industry and
biomedical treatment industry are probably wanting there to be a kind of oversight,
not just any oversight,
but where some of these small clinics are like exploiting that kind of a gap.
My question is a follow up on the yuck factor and the informed consent issue.
I was wondering if there's been any efforts made to
obtain retroactive informed consent on embryos in research.
You mean from the people who-
From the parents and donors specifically.
The problem is I understand is that a lot of clinics have had thousands of
leftover embryos and they contact the people, they'll send a letter.
As you know this costs us $500 a year to store.
Do you want us to continue to store it,
so send us a check or let us know if you no longer want us to store it.
And they get no answer.
So, it's hard.
A lot of people, because either people are-
and this is your future potential kids and well,
maybe someday we'll use them and so,
there's a lot of feelings and also the parents just don't respond at all.
So, I think that's part of the problem. But it's a good question.
I don't know in terms if there have been efforts to get retrospective to say.
Although there is the ability to reach out, again,
if either in the process of do you want to continue to pay the fees for freezing?
If not, what would you like us to do,
now how much response is received is different.
But I think there is a fair amount of attempts to contact.
Again, how successful- I don't know.
They don't get a lot response, yeah.
And there there are sort of two times when you might ask people what do
you want us to do with your embryos in the event of different things happening.
One of those times is before the embryos are created.
And so clinics have now gotten
to the point like they didn't have this down pay initially,
but they'll actually run people through scenarios and they can sign a form.
If you die, what do you want- it should go to my partner,
it should it go- So,
you sign off on a bunch of stuff in advance.
And theoretically, you don't get to,
probably even say it and they are like,
if we don't pay your a fee,
we'll do whatever we want with your embryo sort of thing.
But they just actually don't like to do it,
because they've freaked out that it will come
to the media and it'll be bad press and other stuff.
So, it's not that they couldn't do whatever they want maybe,
because they might be able to treat it as a,
it's just that people don't actually do that.
They don't want to do that, in fact the clinics.
For a lot of the stem cell research,
you do need to give specific consent.
So, the second thing about it, so usually,
even if you say it upfront like this is what we want to happen in different scenarios,
before you would actually donate those embryos to that researcher,
you would get consent from the person.
And that's a general rule from regular research.
It's not just some special rule for embryonic stem cell research.
And so, you need those people to sign off on it,
on the particular thing that you are going to actually propose to do.
And that does not seem inappropriate to me that you
would actually require consent from the people
whose materials you are going to use in research.
There is a version of your question,
which maybe isn't what you mean,
but we are like, there was a time when it was like,
they were these embryos that people wanted to donate to
research and they maybe had used a sperm donor,
and the sperm donor had said you can use my sperm to make an embryo,
but they hadn't said and if the embryo is left over you can use it for research.
And some guidelines were like,
you need the permission of everybody whose genetic material is involved, not just.
So theoretically, you would be,
we go back and get the- No.
They don't. It's impractical to go back and get consent from those gamete donors.
It's not that you would go back and get consent from the embryo donor,
you would get consent from them at the time of donation.
And that's where some of these issues come up,
like if you can't get in contact with them then you can get the consent.
And then what do you do?
Well, I mean the clinic has a dilemma about what to do,
but you can't do research. Like that is just clear.
And what's actually interesting about the Obama era regulations,
one of the biggest critiques was that you did not have to get
consent if it was basically an anonymous gamete donor.
You had to only get consent from basically,
those who were in custody of the leftover embryo,
which meant basically if they gave consent, the privacy rights,
the rights to what you do with your materials of the person who donated the gamete,
actually very much could have been arguably violated.
And that is still the policy.
The other problem is two thirds of IVF clinics are private.
They are not affiliated with hospitals, universities.
So, they're not even thinking about research, a lot of them.
They might not even be offering embryonic stem cell research to the people,
because they don't have researchers that they are
connected with and then it's not part of what they offer.
And so you might be all Iike,
"I want to donate my embryos to embryonic stem cell research".
And they are like," We don't have that link.
We don't have that option." We have this,
they have this other things you can do.
Okay. I think we know we can probably go on and talk about many other topics too.
But I think that we have to wrap it up.
I just want to thank you guys so much for joining us and it's wonderful, [inaudible]
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