The Bioethics of Stem Cell Research and Therapy: Part One

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En provenance du cours de American Museum of Natural History

The Science of Stem Cells

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American Museum of Natural History

The Science of Stem Cells

59 notes

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.

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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.

Introduction to The Bioethics of Stem Cell Research and Therapy and Conclusion2:55

The Bioethics of Stem Cell Research and Therapy: Part One64:21

The Bioethics of Stem Cell Research and Therapy: Part Two28:52

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Dr. Zehra Dincer
Course Instructor

Okay, hello everyone, and welcome to the Museum of Natural History,

and to our Stem Cell Ethics panel.

So some of your faces are familiar, but some are new, so

I just want to give you a little context for our panel here tonight.

So this is part of our five part stem cell course here at the museum.

This is the first year that we're doing this.

And this was brought to you from a grant from

the New York State Stem Cell Science Program.

And we spent a lot of time delving really deeply into the biology and

the complexity of many of the lab techniques related to stem cells so

far and we've talked about induced pluripotent stem cells.

Last week, we talked about embryonic stem cells.

We also had some conversations about human animal chimeras.

And so there are a lot of issues that's we've talked about in depth

from the biology perspective, but we had have not

at all talked about any sort of ethical concerns related to these things.

So I think we have a lot to talk about tonight in our panel.

And so we have a wonderful group of people who are joining us here today.

But before I introduce them,

I'd like to introduce my colleague Dr. Zehra Dincer,

who has been doing a wonderful job as our stem cell educator here at the museum.

But just to reiterate, and give you a little background about Zehra.

So she earned her PhD in biochemistry, cell and

molecular biology from Wilde Cornell, Sloane Kettering.

And her doctoral work focused on deriving precursors of sensory organs and

pituitary hormones from human embryonic stems cells.

She holds a patent for her discovery, and

she talked to us a little bit about it last week.

But she is a little bit too humble about it.

And she is the first person to have ever done what she did before.

So Zehra, why don't you come on up.

>> [APPLAUSE] >> Welcome back everyone.

I'm Zehra Dincer, I'm stem cell educator at American Museum of Natural History.

And tonight, we have our panel discussion on bio ethics related to stem cells and

regenerative medicine.

Stem cell research offers tremendous potential for biomedicine.

It also raises important ethical and policy challenges.

We are hoping to have an interesting conversation in the intersection

of science, technology, public policy, and ethics tonight.

We are happy to welcome such a distinguished group of

experts as panelists.

Before we begin, I would like to introduce them.

First, I would like to start with Josephine Johnston,

she's coming from Hastings Center.

She's an expert on the ethical, legal, and policy of

biomedical technologies, specifically human reproduction and genetics.

She's a lawyer and has a bioethics Master.

She's also our international expert.

She practice and work in New Zealand, Germany, and currently in US.

I also would like welcome Dr.

Robert Klitzman, he's a professor at Columbia University.

And he's cofounded and codirected the Center for Bioethics.

He's a prolific writer, has written over 120 scientific articles,

eight books regarding bioethics of stem cells,

assisted reproduction, and research ethics.

He also has an appointment with the New York State Stem Cell Commission, and

US Department of Defense.

And also, I would like to welcome Beth Roxland.

She's an associate at Medical Ethics Department at NYU.

She also legal and health policy consultant.

Beth brings insight from companies and law firms.

Like Josephine, she's also trained as a lawyer and has a bioethics Master.

She has created policy, lecture, and publish on the range of stem cell

topics which we will be talking about in details tonight.

So I would like to welcome everyone.

>> [APPLAUSE] >> So

now let's jump right into our discussion.

Stem cells have been used in medicine since the first

adult bone marrow transplantion in 1968.

And stem cell therapies have saved lives, yet

stem cells have also generated a lot of controversy in the past 40 years.

So why are stem cells controversial?

>> [LAUGH] >> It's a big question and you can.

>> I would say that, or do you want to go?

>> You can start off.

>> Stem cells are controversial because there's a question about

the moral status of a stem cell, I would say.

That stem cells, which as you all know, form when egg meets sperm they create

a cell that then goes to two cells, four, eight, etc.

And many people think that in the United States, it's not my opinion, but

many people do, that stem cells are the equivalent of a human being and

therefore we shouldn't do research on them.

Others of us say that we believe that,

given that stem cells can potentially save hundred,

research on stem cells could potentially save hundreds of thousands of people,

millions of people's lives, that it's okay to do research on them.

But I would say that's, in my sense that's sort of an underlying tension

in terms of why there has been controversy.

>> And I think it's important to point out that you are,

there's something that happens a lot actually is that people

are thinking that stem cells are only the ones from embryos.

So you can get stem cells from any one of us, from your skin, for

those who have taken the class.

But it was after the first time that stem cells were derived from human embryos and

you had embryonic stem cells that you had public debate.

Not just in the US, all around the world about doing that kind of research

using human embryos to create a material that you would use in science and

potentially in medicine didn't sit well with a lot of people.

Some people who think that an embryo is a person but

some people who think that an embryo wasn't a person but

is significant in some sort of way, might have felt some discomfort or

ask questions about research that takes human embryos and destroys them.

And research sometimes that actually makes embryos for

the purpose of them taking the cells out.

And you can't really take the cells out without destroying the embryo.

So I think I don't know if regular stem cell like non

embryonic stem cells have really gotten much public discussion, a bunch attention.

But I certainly think that embryonic stem cells were obviously an enormous issue,

for like a decade.

>> Yeah, no, I agree with, well both but as Josie said, I think there is definitely

a differentiation of the sensitivity of embryonic stem cells versus others.

I think there is though still also the larger picture of playing God,

which we have in science generally.

Because embryos, embryonic, all stem cells with the pluripotent potential,

have so many, are we going to create meat from stem cells,

that aren't embryonic necessarily?

All of the variations and what you can do with a stem cell.

I think it has been sensitive,

I think definitely the embryo derivation is what started it and I agree we haven't

had quite enough discussion over why we're still uncomfortable with other

Facets except for possibly also cloning, which gets confused quite a bit.

But I think there's a number of tensions and challenges in the area.

>> Yeah, certainly, anytime you're also thinking about using stem cells.

Human cells and

animals, when you bring those two together even if it's not an embryonic stem cell.

If you're using pigs to grow human hearts, and with these kinds of things that could

involve stem cells, but not necessarily embryonic stem cells.

You're already giving into a territory that is at least uncomfortable if not

actually articulate.

Some people have very good reasons for why they think it's sort of-

>> Yeah, the ick factor-

>> Controversial or-

>> Yeah, great.

So what moral status does the embryo, the human embryo have?

You guys are all probably, it's a deep discussion.

And I'm just trying to get if there's, what does the rationale

of different opinions, and how can we find a middle ground?

We debated that actually when I was chairing the ethics committee of

New York State Stem Cell Board which Robert is a member, there is no answer.

I mean, I think we all know that there is no answer of what the moral status of

the embryo is.

As it's been attempted to build consensus at least on New York state's level, I

think the best I was ever able to sort of get at, and I think the board would agree,

was an agreement to disagree on the moral status of the embryo.

And yet, what can we do, sort of,

properly knowing that people will disagree.

A large percentage of the population believe science must proceed.

But how do you be respectful of opinions that believe that an embryo is a human or

deserves at least absolute adult human rights and status?

But- >> Yeah, I think if, so if the answer was

that most people thought that embryos were the same as babies or our children or

our adults in terms of moral status, then we wouldn't be having this conversation.

because we just wouldn't be doing stem cell research or using embryos,

we wouldn't be destroying embryos.

So I think it is the case that most Americans, polling shows,

are in favor of some embryonic stem cell research going forward, which indicates

that they don't think that embryos are the same as adults, or children, or babies.

But the fact that the most people are a little cautious about

just how gung-ho they want to be about it,

shows that they think that embryos are not just like any other cell.

It's not like doing research on some skin cells, or some hair or.

They do think there's something special there.

So I feel like you could say that most people feel like embryos have some

sort of intermediate status, and people don't agree exactly what that is.

But that is why you can create a kind of policy approach that allows some of this

research, because we wouldn't even do it if we thought they were human, people.

But doesn't allow just anything to necessarily occur, so

that there is at least some sort of middle there.

And of course, you can't escape especially in America the abortion

debate is an element of this discussion.

And of course, I will just point out that there is a big difference between

an embryo that is inside of a woman and one that isn't.

And that's a really significant factor in the discussion so-

>> I would say that if, sort of,

this is the moral status of a human being, and the moral status of bacteria, or

skin cells, or hair cells is here.

It's somewhere in between, and where exactly, it's hard to say.

And that, I think, is where there gets to be debate.

And of course, I think the sort of compromise that was made with research

that is held pretty much is that an embryo up to around 14 days when it's

an undifferentiated mass, is one thing.

Around 14 days, it begins to differentiate, this clump of cells.

At some point this clump of cells becomes a human being.

And at 14 days begins to differentiate,

you have the beginning of a dividing line that becomes,

it's called the primitive streak, and that eventually becomes the nervous system.

And so the consensus has been that up til that point when it

becomes differentiated that it's okay to do research.

That may in fact, I hate the term, destroy the embryo,

but that's really what it's doing.

So therefore, I think people agree at early stage okay for research,

after that more problematic.

>> That's it, great.

So can you please talk about history of political landscape and

policy regarding stem cells?

It's a big question, but

can you walk through Bush era and- [LAUGH] >> You just asked us

what the moral status of the embryo was.

So I mean, this one's actually the softball question.

>> [LAUGH] >> So

I guess the date August 9th, 2001, will be burned into my brain, as someone who's

been following stem cell research ever since I got a Master's degree.

Prior to the Bush administration policy, under the Clinton administration actually,

because they had already isolated embryonic stem cells.

There was actually the formation of a movement to start regulating it,

to start guidelines.

August 9, 2001, President Bush announced in his speech,

it wasn't even an executive order.

Basically, I don't want to say ban.

But that federal funding should only be used for embryos or

embryonic stem cell lines that were already in existence and

approved by the NIH as of that date.

And it's sort of, for people who are into politics, it's actually kind of

interesting that it was this big policy, actually was just verbal.

It was just part of a speech.

It was obviously then moved forward by the NIH, and what have you.

But again, the Bush administration policy was as of the date that he said that,

whatever lines were in existence, it was sort of almost the cat is out of the bag.

The NIH has approved it, but federal funding will not be used for

anything other than those lines.

Taking one step back, there are two pieces

of thought that basically dominate how US policy works.

There's the presidential policies and then there's the congressional policy.

And one of the overriding pieces that actually comes even before whatever our

administrations say is the Dickey-Wicker Amendment.

Many of you are probably familiar with the Dickey-Wicker Amendment.

It's been a rider to the, I believe it's the budget for HHS, and is

a rider that has been attached every year- >> Since 1995.

>> Yeah. >> But there was a version of it-

>> Right, yes.

>> Back into the 70s.

>> And Dickey-Wicker, it applies way beyond stem cell research.

Dickey-Wicker basically says, there will be no federal funding for

either the creation or destruction of an embryo, period.

And so, and that amendment, that rider is still in place.

So to any extent, there is presidential, executive branch, limited ability

as to how far the President might want to go given that that rider is there.

And again, that applies to all researches.

This is not stem cell specific,

it applies to lots of other things I think beyond research as well.

But so the Bush administration policy 2001, we get to President Obama.

There were very high hopes that he would sort of go almost as far as possible,

bumping up against Dickey-Wicker.

You couldn't use federal funds to either create or destroy an embryo.

But the hope was that President Obama Would completely overturn

what the President Bush administration policy.

While Obama did in fact lift a lot of the restrictions,

it actually did not go nearly as far as I think some of the advocates had hoped.

And to my knowledge, there's been no change in that,

certainly under this administration yet.

Under President Obama, we can now use any kind of embryonic stem cell line but

that could not have been used from an embryo that was created for

the purpose of research.

So we can only be using federal funding for

lines that were derived from clinically excess embryos.

So clinical, IVF, a couple, individual goes to a clinic,

has excess embryos after the fact.

Do they want to donate it to stem cell research?

Lines are derived, federal funds can go to that.

But there was a very clear decision to be somewhat conservative and

not allow federal funding to go to embryos that were created for

the purpose of research.

And there have been, I think there are, and I don't know if you

want to go this far but there are certainly some issues with that.

I think one of the principal issues being, and I'm sure most people will know that

in order to actually go through IVF you need to have quite a bit of money.

And the number over their percentage of leftover embryos,

clinically excess embryos are largely Caucasian and from wealthy folks.

And so to the extent that we are attempting to a further research using

embryonic stem cell lines, we're not going nearly as far as we possibly could be.

Because we're not allowing federal funding for

the creation of embryos that might be for other populations, let's say.

>> I would just add everything Beth said is correct.

One is that when Bush announced his policy at the time,

it was said that there are about 65 lines out there that have already existed.

It turns out the number was [CROSSTALK] 22 or something like that.

Secondly specifically I think that a lot of people hope that Obama would

now allow was to use federal funds to create new lines.

It is one thing to say that there are lines that happen to be out there.

But federal funds can create new lines to include a wider diversity of people,

etc., in terms of the genes involved.

So I think that was something people hoped for that didn't happen.

And I think one that happened as a result of the federal funding is

that states then jumped in.

So you first had California that had decided they

would spend $3 billion, I believe is the amount that they had a proposition,

a bond- >> Yeah they had like a referrendum-

>> Right, and so they decided they would,

as a state, even though you couldn't use federal funds,

California as a state has spent 3 billion.

And then New York State actually decided it would spend 750-

>> 600 million over 11 years,

sorry these numbers are kind of [LAUGH].

>> So that was good.

>> It's like a button I'm like, August 9, 2001 [LAUGH].

>> I mean, one of the things I think is really with us noticing about the way

that this works in this country is that you have a set of rules that

hinge on where your funding comes from for your research, okay.

That is really unusual from an international perspective.

A lot of times people say President Bush banned embryonic stem cell research or

something like that.

He didn't ban it.

It could absolutely take place.

You could do cloning in the United States.

You can make embryos for research from donors.

You can do almost anything, as long as you don't use federal money for it.

The restrictions were about what you could use federal money for.

Now there are all sorts of reasons why there is the mechanism here, but

it's a very unusual approach.

Internationally, the approach is we have a law for our country,

that's the law that's- >> Mm-hm.

>> That's how it all goes, we don't differentiate between things

we use federal money for and things we didn't use federal money for.

So it's a pretty unusual setup

as a way of regulating an area of research or activity.

The other thing that I think is really interesting, and

if you're a lawyer you can geek out on this, because I did, even before I came to

United States I had already studied, this was like, this is amazingly weird.

Okay, there is a- >> That's

the only thing weird in America, right?

>> [LAUGH] [CROSSTALK] >> There is a federal law

that says you cannot use federal money to do anything harmful to

an embryo at all including make stem cells from that embryo.

But there is a federal policy that you can use

federal money to research those cells once they're out.

So we have the situation where if you've got an embryo left over from IVF and you

want to take the stem cells out, you use private money, whatever your statement.

And then once you've got those lines out,

now you can do research on them with federal money.

And it sort of, I mean, I know someone who is heavily involved in making this policy,

and it's very clear for policy.

But it is a little weird, counterintuitive, right?

Like- >> It was.

>> The federal government's like our hands had nothing to do with

destroying the embryo.

But once you get those cells out, here's the money to do the research.

That is actually- >> That's exactly what it is.

>> It's a very strange approach.

>> And I think it was, and we know it was Harriett Robb who's now at Rockefeller who

actually wrote that opinion.

>> Yeah I read that thing before I even came here, imagine,

I had so much excitement when I met Harriet, I was like wow she's so fast.

>> I was seriously like in awe as if she's like a pop star because I had so

much- >> So

the memo that was written by Harriet Redford Clinton of like

why she thought they could get through the Dickie-Wicker this way.

It's really clear of a law.

But it is also on a kind of intuitive level, takes a wee bit of processing.

And actually the whole thing was challenged in court in 2010 to 2012.

But by then, the federal government had using this approach, where they wouldn't

fund the derivation but they would fund the research for a decade, and the courts

were like, we are not interfering in this interpretation of the law.

You couldn't make it up, it's a fascinating kind of approach to

regulation, and it's a fascinating way through the Dickie-Wicker amendment which

keeps getting added to every appropriations bill, but

still allowing the research to go forward.

And it's the only country I know that's gone even close to a policy like this is

Germany which said for a while, you can't make stem cells from embryos.

But you can import them, and then do the research,

which is kind of the same sort of idea, right, yeah.

>> It seemed, at least on the surface, and I think it still does, an attempt for

the administration to go as far as it can given congressional policy.

>> Yes, absolutely.

>> So that the federal funds are not used in what might be considered abortion, or

anything having to do with destruction of an embryo,

and I'm sorry if I wasn't quite clear on that.

And that's also, in part,

why I think there was some disappointment in the Obama administration policy.

Because even though you're blinding yourself for

the federal funding as to where the stem cell line came from, there was a hope

that the Obama administration would say we'll blind ourselves even if you created

the embryo for research purposes and not just clinically excess.

[CROSSTALK] And it did not go that far.

>> Yeah, that's right.

>> And, of course, abortion again,

is the reason that we have such a screwy system so to speak.

>> No, it's a big part of it.

I mean, yeah.

So I'm wondering about international landscape in a way if any country

is more permissive or less permissive comparing to the US.

>> Well, I think the US is both being sort of simultaneously permissive and

not, right?

So you have these funding rules which are fairly restrictive on their face.

But you also have a background where you don't have national laws on it.

So in some countries like the United Kingdom, or Canada,

or Australia or a bunch of other places, >> Japan.

>> You have national laws that affect stem cell research and

effectively regulate it, embryonic stem cell research.

But at least in the UK, for instance, those national laws allow a lot more

things to occur than the federal rules do here.

So you can kind of have this, it's both more permissive, but also more controlled

because everything is subject to oversight.

There separate tracks for private money, so it's so generous I think.

It's an unusual combination of being both quite restrictive, not at least now,

but still.

And also quite permissive on the other hand,

where it's not the approach taken by other countries.

>> Certainly, and there's also, and you could speak to this as well, international

laws not just on the derivation, but on who can give informed consent.

I remember Japan actually being one of the most interesting ones.

It said that a husband and a wife must give informed consent.

It was not the gamete donors.

But there are international laws regulating various parts of this.

It's not all about just the derivation, let's say, aspect, there's more.

But Josie raised a very good point about

the way the US works which is that a lot of the restrictions are tied to funding.

Such so when Robert is talking about how states started to get into the act which

is a very odd thing in the US.

Most funding comes from the federal government.

But because of the Bush administration policy and the promise of stem cell

research states states started to get into the act, specifically,

of funding stems cell research with the hopes of building enterprises,

potentially, getting license rights back.

But mostly with their hopes of building their own enterprises.

The states have been able to go further than the federal policy.

Which is exactly why they were in place.

And private funding is,

it almost like the IVF wild west because there aren't restrictions.

>> And there is an interesting policy in New York, right?

So New York states stem cell money, theoretically,

I think, can be used to create an embryo from donors?

>> Yes.

>> And then they even allowed for the payment to the egg donor,

which is a whole another topic, so- >> That was my puppy, that was my thing.

>> So yeah, the one thing I do think must be a little confusing for

researchers, right, because depending on where their money comes from and

which state they're in, they can have really different situations happening.

>> Yeah, it's also quite hard for universities, actually.

It sounds like okay, well, it's clear that's state money that's federal money.

But the problem is that the university Columbia,

Cornell, etc, the feeling was when it was decided that we could use state money and

could not use federal funding.

That we had to make sure that, for instance,

no federal funding went into that building or that lab.

So for instance, if federal funding was used to help build the building, well,

that's federal funding being used if you were doing stem cell research there.

And the feeling was universities took very,

decided to be very conservative about it, just to make sure and be completely

squeaky clean that no federal money was being used at all in this lab.

I just want to point out a few other things.

One is you mentioned informed consent, which is very important.

This was another area where part of the problem that

there is not been further advances, I think, there's been many, but not as much.

Is because the feeling in using stem cells derived from clinical purposes

is that there needs to be very clear informed consent from both the man and

the woman saying, yes, you can use the leftover embryos for research.

And the problem is that there are hundreds of thousands of leftover embryos in

United States.

That because there is not good informed consent for

research explicitly, they're not being used.

The reason is there's a lot of leftovers, because a couple, let's say,

that's infertile may make eight or ten embryos, and

only use one or two and have a bunch left over.

They don't want to throw them out.

The doctors don't want to be throwing away embryos.

What do you do? Do you flush them down the toilet?

These are potential human beings.

You can imagine the uproar.

And so there's been this odd situation there, too.

That's been one of the obstacles.

>> So Bob, do you think- >> Informed consent is important, but

I think the problem is doctors aren't often including getting consent for

research purposes.

>> I was going to ask about how many embryos are available for research really,

anyway?

So there was a survey done that showed that there were something like,

190,000 embryos frozen right now in the clinics.

But one should not assume from that that there are that many embryo available for

research because in the course of fertility treatment,

people freeze embryos all the time.

It's part of how you make your treatment work, but

that doesn't mean you're not going to use them.

So we don't know, of those that are frozen right now,

how many are going to be used at some point, because it's predicting the future.

Sometimes people think they'll use all the embryos, and they don't.

Or they wait a while after they think they've finished and then they.

And then, of those, how many would actually get donated to research?

And it could just be far fewer.

So I feel like,

even that discussion of how many really are available for research.

How many are really left over?

When do you know that your embryos are left over?

>> So tons are left over.

>> It's very complicated.

>> There's actually many, many.

>> I think it's very complicated and people don't like to make a decision about

what to do with the embryos, so they postpone it for a long time.

Which you could critique there, but on the other hand it's sort of understandable.

It's an intense decision for people.

And so there's so many factors in there that actually it goes back to

a point that you made which is that just limiting ourselves to embryonic

stem cells that come from left over embryos is, in many ways,

a very sub optimal approach from a scientific perspective.

>> And then when you add the fact that there had to have been consent to do

research on top of it.

>> Yeah.

>> Which is also part of the Obama administration, at least by guidelines.

One side point, The Vatican and now The Vatican might have revised the statement.

But I want to say back in around 2010 The Vatican was asked,

basically, what do about frozen embryos.

And this goes to moral status of the embryos and

the fact there are left over embryos.

And The Vatican actually came up with no response.

What they said was, these embryos should never have been made.

The Vatican will not comment on whether or

not it is moral to destroy them for the purposes of research.

Because it's, obviously,

a big sort of moral quandary that we have leftover embryos, let's say.

>> Yeah, no I think we do,

I just don't think that the number is the number that are right now frozen.

>> It was actually quite interesting the Vatican would not really answer that

question because, Catholic, and I am not so I hope I'm not getting this incorrect.

But according to Catholic doctrine the embryo should never have been created.

>> Yeah there is no IVF on Catholic doctrine.

>> So to the question about how many are left over, I don't know the number.

But a state had approached Art Caplin and I actually wrote a long law review

with Art They were a bunch of clinics that were about to go defunct.

And they had a lot of folks with many,

many leftover embryos who had stopped paying.

The state wanted to know whether they could treat it as abandoned property.

And therefore take on the embryos and then donate them to stem cell research.

Because it felt that it was the morally, I guess,

superior way, more proper way than letting them get destroyed.

I mean, it's an interesting analysis, but

even states there were many, many left over.

>> I think there were probably tens of thousands,

I just don't think that it's the same- >> I think it's most.

>> Really? >> So what I hear from IVF docs is

that most of the embryos that they have frozen will never be used.

>> Really?

>> Now maybe that's 60%, but most of them,

the problem is that people have leftover embryos and they will feel ambivalent.

In other words, here's my potential future kids.

Yes, I'm now 45, but maybe I will want another, or maybe I'm 42, or whatever, and

so they feel, well, we don't want to throw these out.

And the problem is IVF clinics will say well, it costs so

much to store them per year.

Couples will stop paying.

And IVF clinics then feel though that we can't quite throw them out.

Because again, it gets back to the moral status.

>> It's an embryo.

>> Are embryos property, or are they like shoes, or are they something else?

And the feeling is that in some ways, they're not just shoes.

But what they are is unclear, so this often comes up.

Also there are debates somewhere in the media for instance, so

Sofia Vergara who's the actress- >> Yeah,

I was going to ask actually that one.

Who get the custody of the embryo?

[LAUGH] >> Yes, right, so

there are custody battles over embryos where a couple will divorce and

who gets the embryos?

And the consensus in courts, which I think is correct,

is that both parties need to agree what to do with them.

So in that case, which got a lot of press, she's the highest paid actress,

she was a year or two in Hollywood, her ex-fiance sued for custody of the embryos.

So you have things like this happening.

You also had there was a couple that died in an airplane crash that was

quite wealthy.

They had embryos in storage.

So, are the embryos the heirs?

There are interesting problems.

And then so- >> Yeah, that comes up quite a bit, yes.

>> Right, so I can adopt the embryos and raise them, do I get the money?

So you can imagine, again, that these are one of the reasons we have bioethics,

because science is presenting us with ever new challenges technologically.

And we're trying to figure out behind trying to catch up,

looking at the ethical, legal, social implications of these new advances,

where we now have these new entities that we have these,

I won't say things, but embryos and what are they?

>> And you raise actually a great point, which is that we talk a lot

about what we do with embryos if we destroy them for research.

But here we have embryos that are potentially left over and

just going to be destroyed.

And no one really talks or regulates that.

And I mean, there's one of the other areas that we had looked

at on this abandoned property question.

We actually went through the entire,

the custody of the embryo during the divorce and how do courts treat it.

Which would implicate the moral status of the embryo, but also things like homicide.

If you kill a pregnant woman, is that two homicides?

Is it one?

All of these sort of legal questions also can affect sort of the ethics and

analysis of the status of the embryo or fetus.

>> There's also interesting cases where a couple will have leftover

embryos- >> [LAUGH] Sorry,

now we're just totally [INAUDIBLE] >> [LAUGH]

>> We're so dorky now, I'm sorry.

>> I'll finish and then we'll go on.

But had leftover embryos, gave them, four embryos or six embryos,

to friends of theirs.

They used two, they had two or four left, they gave them to friends of theirs.

And the first couple said you had no right to give my embryos to that person without

my permission, I don't like that person.

>> Would just say those people have amazing fertility because most of the time

when you give embryos to someone, they use them all up and

none of them can even turn [LAUGH] into babies.

So that's impressive.

>> Part of the issue now is that there's a push to only implanting one embryo at

a time versus two, which was more the norm a few years ago.

>> I just have one question, and then I think we should share with yours because-

>> The audience has questions too.

>> We have a lot of topics to get to, this is only our first topic.

>> [LAUGH] [CROSSTALK] >> This is what happens when you put three

people who kind of know each other and love this stuff together.

[LAUGH] >> No, my question is that so because of

these limitations, there's been a lack of diversity in the stem cell lines.

So how do you think that have impacted the research?

>> Well that's in part, we're focusing very heavily on embryonic.

Because of the, at least in the US, funding restrictions,

there was a huge shift towards IPS cells or

disease specific lines, other ways that we might be getting at that.

So it just would sort of know that we should adjust.

I mean, even though the hot topic is usually embryonic,

the fact of the matter is a lot of the research is not necessarily in that area.

>> I'm not sure that we know the answer to your question.

So a lot of the concern about the diversity,

the genetic diversity of the lines, if you like,

has been premised on there being treatments that would be given to

people and how do you make a good match, all those kind of stuff.

And I don't think we are there yet, so we're not at the point where the problem

really becomes apparent how serious that problem is.

That's my impression of the science right now, is that.

>> I agree. >> I think it feels like it will be at

some point some stem cell banks, and they were saying that because America is such

a diverse country, I think 220 cell lines may be covered of whole population.

But for Japan, it's even less because they have a more homogenous population.

So but we are not there yet.

[CROSSTALK] >> Yeah, I think that's right.

And the model that I sort of felt like was going initially with

stem cells was like everybody's going to have individualized lines made for

them that match with them and stuff.

I don't know if that's really the paradigm anymore.

You'll notice that we used to talk about personalized medicine, and

now we talk about precision medicine.

because I think there's been a move away from this notion that each one of us is

going to have treatments personalized to our own make up.

And we can derive embryos from my skin cells and make me special lines.

And I think there's been a move away from that towards something that would be

a little bit more more precise than what we have now.

But not personalized or individualized in a way that we maybe imagined initially.

>> I would say, I think what it speaks to also is there is a tension between

the promise of embryonic stem cells in terms of treatment and the reality so far.

And as in other areas of genetics, we thought that we would be further by now.

And I think part of the tension is because of funding.

I think for NIH to get billions of dollars of funding from Congress and

to get the support of the American people, politicians and

scientists need to say, look, we're going to get treatments out of this.

And the reality is that treatments can take a long time to develop.

So, in some ways, the analogy is if someone asked Christopher Columbus in

1500, what did you find?

He'd say, I found some islands off the coast of India.

And it took hundreds of years to sort of map out really what's there.

Aand so similarly with genetics, the more we learn,

the more we realize how much we don't know in many cases.

>> So I'd like to also ask about, because we have now new technologies,

you can even isolate stem cells without destroying an embryo.

And I'm wondering, is there a way past that laws or FDA regulations People

can use it to rather than destroying embryos for the stem cell research.

Because Robert Lanza, he published a paper, he still have the embryo without

destruction, but you can also have the cell line at the same time.

So I'm wondering if the FDA does not- >> As far as I know,

I don't know who is- >> [CROSSTALK] Do you know any roles

related to the issues we just discussed about in here is that's they're looking

for safe, proof of safe and effective treatments and not seeing that.

So far I guess as a general thing.

So yeah, if you can create embryonic stem cell lines without involving embryos or

harming embryos, or destroying embryos, whatever you want to call it,

then that would be a way around that particular issue, which is a big issue.

And that's what iPS cells were initially thought to be able to do.

Right? That that would be the solution.

We would just make embryo-like cells out of skin cells and

then we wouldn't need to use embryos.

And so far, I don't think anybody's recommending that we've gotten there yet

and we can abandon embryonic stem cell research.

Yes, so but it's not impossible for

me to imagine a future in which we aren't really dealing with embryos

>> Mm-hm.

>> Anymore.

>> Yeah, so the feeling, so iPS cells is as most of you know, or

you can take skin cells over induced pluripotent cells.

You can take a skin cell and, with chemicals, get it back,

keeping up the form.

>> [CROSSTALK] Send it backwards.

>> Send it backwards to be able to create more various cells.

More skin cells or protect brain cells, the idea was,

it would be great if you could take skin cells, turn them into brain cells into

someone who has Alzheimer's disease or Lou Gehrig's disease, you could sort

of put them in there and they take up, fill in for disease or dead neurons.

The problem is that we're not there with the science yet.

And what happens is they end up forming cancers very easily.

So if you take a skin cell and you put in a few chemicals and

you let it grow in a dish, yes, it will grow.

But it also grows abnormalities, and so we haven't quite figured out how to get it to

grow the good cells, and not have cancers growing as well.

>> So we still need embryonic- >> Yes, I mean [CROSSTALK] think of that,

again- >> It's [CROSSTALK] I think it's in part

because we can't take the adult or

non embryonic stem cells back to a fully- >> Yeah.

>> Nascent state.

>> Yep. >> And the only,

to date, as far as I know,

the only way to actually take it to a truly nascent state is to use embryonic.

>> Mm-hm.

>> We could take more advanced cells and reprogram them back.

They can, they're pluripotent,

they're not- >> But maybe not even as pluripotent as we

[CROSSTALK] >> Exactly, exactly.

>> And people know what pluripotent is, and

omnipotent, so- >> I think our class was really

good at it.

>> [LAUGH]. >> Okay, right.

>> Everybody knows that pluripotent cells

are giving rise to [CROSSTALK] >> We should have

the clicker- >> Yeah,

clicker. >> [LAUGH]

>> Test them on the spot.

Totipotent cells can become everything.

Pluripotent cells can become almost everything, and

more specialized cells can become, you know?

There are heart,

there are blood stem cells that can become different kinds of blood cells.

>> Yeah. >> But they can become

>> Right.

>> Neurons.

>> Great.

So let's change the gears a little bit, and let's talk about some,

we also talk about some recent developments in our class.

And one of them was, this year, we heard the first baby was born

in Ukraine with mitochondrial transfer technique.

And I [LAUGH] you know where I'm heading.

>> Yes I do.

>> Would it be [LAUGH], would it be ethical for

a scientist to try to create babies with three individuals DNA?

And >> So I would say, so

this is, the problem is that the vast majority of our DNA

is in the nucleus of the cell, 99 something percent.

But in a cell there are also these little organelles called mitochondria,

that have some DNA also.

And in a certain percent of people, small percent, less about 1% at most.

They can get mutations and lead to disease.

If you have a mutation, not in the main part of your DNA, but

these little organelles.

So what mitochondrial transfer therapy is, if I have this disease in my family and

it's in these little organelles- >> Or if I do.

You have to be a woman to have it.

>> You need to be a woman >> [LAUGH]

>> But I'm being omni,

whatever here [LAUGH], so right.

So if a woman has this, you could take the nucleus out of

the cell that has these diseased mitochondria, and

put them in the cell, take out the nucleus of another woman's egg.

>> Egg. >> And you can therefore have a, and

the first woman could then use that egg which has her nucleus,

but done under the bad mitochondria.

So research on this was banned in the United States by the FDA,

and it was allowed, however, in Great Britain.

And actually went to Parliament which voted to allow, receive,

just research on this.

And as you say, in Ukraine, there was a birth and

then there was a doctor here in New York.

>> In Mexico, I think.

>> Yeah. >> Right, who did the procedure in Mexico

because it's illegal in the US but not in Mexico and so the baby was born.

So my feeling is that personally that

if this is a way to avoid passing on terrible diseases.

So technically, the baby then has three parents, right?

Because it's the father, the mother, and the woman donating the

>> But at least not call them parents.

>> Yes, correct. >> Okay [LAUGH].

>> Right. So it's biologically connected to three

people though with 99.9% or something, 99 connected really just to

the present connected to >> The mother

>> Quote, mother and father.

So I think that it's unfortunate the FDA has banned research on this.

>> Mm-hm. >> I think that there are reasons that

one needs caution.

In other words, I think that we should be very careful with it,

we should study the outcomes in the child, etcetera, but

that we should to allow, to completely close the door on this is wrong.

And that to allow some research, I think makes sense.

>> But let's not [CROSSTALK] put it on the FDA though.

That's not fair.

So or I'm just being provocative.

>> Right. >> [LAUGH] So

the FDA had an application to do mitochondrial replacement research,

and the point being that it would then develop into an actual treatment.

Someone applied to them and said, can we do this?

And they had a public hearing,

and they asked the National Academy of Sciences to give them an ethics report.

Which is a really unusual thing,

that the FDA does not usually ask about these ethical issues.

And before they could implement the recommendation of

the National Academy of Sciences, we think that we should be able to do mitochondrial

replacement therapy in these cases with people with mitochondrial disease.

Congress passed one of these nice riders, that you add on to an appropriations bill.

Saying that no public money can be used by the FDA to consider

any technology that involves a germ line change,

which includes mitochondrial placement technology.

So I don't think the F- I mean I don't know.

I don't think the FDA wanted that rule.

And it wasn't in line with the process they set in motion which was we're going

to talk about this.

We're going to ask for expert advice from National Academy.

Presumably they were then going to actually follow that advise.

That was all usurped by this piece of legislation that went through December

25th, then, I believe.

And that's another rider, and it's in place until, last month?

April, I guess it officially expired with the budget, but.

Yeah, the result- >> [CROSSTALK] And then there is-

>> [CROSSTALK] Can't look at this

research, it's not allowed to even consider an application to do it, but

I think- >> [CROSSTALK] And

I think we also need to be clear about how we feel about research in this area and

how we feel about research actually going through potentially not fully

knowing all the effects with a baby born after this.

So how much do we know?

And I think we're covering both, but they are two distinct things.

Should we be doing research in this area and, or

should we actually be going forward with implantation?

>> Right, yeah. >> Actual birth,

it's sort of like a bit of the cloning debate with Dolly.

Dolly looked great.

And then many, many years later, it was, and I'm not saying I'm for or against it.

But we should be clear about the difference between research and

actual implementation in a clinic, at this point.

>> And one of the sad things about this law is that we sort of cut off our nose to

spite our face.

And now that the FDA is not allowed to consider an application to do this kind of

clinical research, people are just going to go and

actually do the thing, not part of a study.

Not research, not overseen by American IRBs.

It's like you make a role that effectively sends

people to Mexico to do their treatment, which really is a predictable consequence.

We are now actually doing it clinically in people.

Versus actually doing it in a more of a research context [INAUDIBLE],

so- >> [CROSSTALK] And

with a country with less oversight.

In many times, with less oversight.

>> I actually like UK's way of doing it because UK

is very often listening to the conversation.

But the way how they tackle the mitochondrial transfer technique is also

very, I think, thoughtful.

They said that you can't have a boy baby because boys,

actually mitochondrial DNA goes through mother to mother.

So we can actually look who's your ancestor just

going through your mitochondrial DNA of the woman.

So it goes all the way back.

So when you have a daughter and do this therapy,

actually you're changing the mitochondrial DNA in a way for the generations.

But if you have a boy, it won't change it, so-

>> It stops with him.

>> It stops with him, so you don't go to the next.

Yes?

>> Children inherit the mitochondrial DNA from their mothers.

But only girls pass the mitochondrial DNA on to their daughters, right?

So mitochondrial DNA follows women, mothers to daughters.

So if you have a son, he would have my mitochondrial DNA, but

he wouldn't pass that on to anybody.

And so that's why they were like, well,

we don't know entirely how this is going to go.

I think it's interesting [INAUDIBLE], but their reasoning was, for now,

let's just let there be sons born.

And then we can see how it goes and then maybe we expand it.

I'm not sure about it, but that was the scientific rationale for the approach.

The UK did this whole thing differently.

They had public debate, they had real discussion in Parliament.

They didn't just slipped something on to an appropriations bill [LAUGH] and

[INAUDIBLE] when no one was paying attention.

It was a wholly different discussion.

>> That never occurs here, I don't know what you're talking about.

>> [LAUGH] >> Jo, I think we're

before the congressional rider.

>> Exactly, no, that's right, so the FDA had its hearings.

But I think they had the hearings because they were like,

this seems like a big deal.

We need to have a public conversation about it.

And then they asked the national academies to give them expert advice following

the public hearing, and I think they were going to then implement that advice.

And that advice was to go forward in a cautious way.

But that all got totally usurped.

>> Well, to keep with FDA hearing and Mark Sauer who was at Columbia was testifying

at the hearing and he felt that it was sort of stacked against them even going

into the FDA but- >> No,

people who work in fertility are very sensitive.

I'm sure it was not like a rah-rah, this is all good kind of hearing.

But I think it was actually ultimately would've allowed that kind of a cautious

approach to go forward, but- >> Which is actually interesting in

the IVF context, which is really, really unregulated, as a general concept.

>> Right.

>> Mm-hm, so I'm also wondering about genetic testing of embryos and

also gene editing, at the same time.

Like if we can, because we are running out of time a little bit.

And I just don't want miss all your perspective on that.

So I'm wondering genetic testing of embryos through

a pre-implantation genetic diagnosis to select disease or

eliminate some of them or select for sex.

I dont think it's legal here but- >> No, it's-

>> [CROSSTALK] You can do that.

>> Definitely. >> Absolutely.

>> [LAUGH]

>> You can literally do that down

the road.

>> Really?

>> Sure. >> Yeah.

>> That is what I was trying to say.

Much of IVF is highly unregulated.

>> Yeah, things that are regulated in other countries are totally

unregulated here.

Related to these issues.

>> IVF is generally considered the practice of medicine.

And there's where you've sort of have a very big difference here when we're

dealing with research, besides the fact that there are a lot of federal funding or

funding mechanisms that then have restrictions attached to it.

The practice of medicine is a very different area.

IVF, almost even more so in the sort of lack of regulation.

>> Yeah, so the issue is, so there are a lot of IVF clinics.

It's new, it's growing fast.

It's about 10% of all people are infertile,

all adults throughout the world.

So 10% of couples who want to have children can't.

And you also have women who at 30 were fertile, but

now they've delayed having children.

Now they're 40 and need assistance.

>> And we're still awesome.

>> [LAUGH] >> Yeah, right.

You're not there yet.

>> Bitter.

>> And you also have single mothers by choice, single fathers by choice,

gay couples, lesbian couples, and individuals, etc.

So it's this multi-billion dollar industry.

About 7% of all people born in Denmark,

narrow born using this reproductive technology.

So it's growing, but it's unregulated.

And so they prefer a model of self-regulation, but

there have been problems with it.

>> And other countries have taken a different approach.

So the legislative framework in the UK that allows them to oversee and

regulate embryonic stem cell research in mitochondrial replacement technology also

extends to anything involving experimental embryos.

So it allows for them to create a whole oversight structure that includes IVF and

other kinds of fertility treatments.

And that's actually issue worth pointing out too is that it's good to bear

in mind that IVF is just one kind of fertility treatment.

There are a lot of different fertility treatments.

And more babies are born following other kinds of fertility treatments than IVF.

But IVF is the one everyone always thinks of because it's the most high tech and

the most invasive.

And so the most famous, but it's not the main one, right?

So it's a whole huge, like [INAUDIBLE],

it's a massive industry in the United States and it is largely.

So they're regulated like other.

Their labs have to be clean, and all those kinds of laws applies to them and

regulations.

But other countries have, for better or for worse, sometimes for

worse, regulated the practice of assisted reproductive medicine.

So they have said things like, you cannot do sex selections with embryos,

you cannot do surrogacy in some countries.

>> Well, it's state by state here for surrogacy.

>> Yeah, and it's different.

But various aspects have been either legislation applying to them,

or sometimes regulations or rules, and And that hasn't happened in the United States?

>> So one of the acutally interesting issues of the parallel of the IVF,

lack of regulation and

the heavy regulation of stem cell research that comes to mind, which is something you

brought up briefly earlier, has to do with the payment of gamete donors.

So in an area where it's permissive, states, Massachusetts,

California, New York, where it's actually permissive to create embryos for

stem cell research, virtually every state, in fact, I don't think there's any state

that regulates the amount of money, in the IVF context, that can be paid to a woman.

We've all read these ads.

College, you play the violin, you're tall,

you're a cheerleader, you can make $20,000, donate your egg.

The states that allow women to donate their eggs to stem cell research,

which is an important endeavor if you're going to create not only embryos but

if you're going to do SCNT and a variety of other kind of stem cell techniques.

Every state except for New York says that you cannot pay women,

despite the fact that you can pay women 20,000,

unregulated amounts if they showed up to the clinic to donate for IVF purposes.

If they showed up to the clinic and said, I want to donate my egg for

almost the higher purpose of research, states say, the states that

have actually addressed this except for New York, which I'm still very proud of.

States say we will give you your direct expenses and nothing more,

which I think is usually around less than $5,000.

You're literally monetizing- >> $1,000 or something.

>> Mm-hm, yeah, New York being the only state that basically said, we basically

think that it's fair given the number of hours involved, the injections involved,

if the woman is going to- >> It's weeks.

>> And to donate.

And yeah, the reasoning, we took a very long time explaining why it is.

But one of the things that have actually hindered, even state, the states that have

tried to be more progressive with their stem cell research programs, there was,

I think, no egg donors in California at all.

So their attempts to do certain things that were more progressive with the state

funds than with federal funds were stymied by the fact that they could not pay

anything beyond direct costs.

Same with Massachusetts.

I think they had one donor once.

The only state that has actually been successful in it, and

we do have caps, we have oversight.

There's a lot that goes into it.

The only state that has been successful in recruiting women to donate their

eggs to stem research has been New York, because of this compensation policy.

>> Yeah, great, so if we come back to applications of stem cells, and

I would like to ask two questions.

One of them is, right now, we have this technology creating sperm and

eggs in mice, not in human.

It's not there yet.

But I was wondering, creating sperm and eggs out of stem cells

may revolutionize options for both research and fertility treatments.

And however, what are the special,

ethical issues regarding creating sperm and eggs out of stem cells?

>> So I would say there's a few.

One is, so this is people who are infertile.

Let's say a man can't produce sperm, a woman can't produce eggs.

We take a cell from their body, and do this, create it.

So one is that, as Beth was saying, IVF remains very expensive.

So this is something that basically wealthy

people will probably be able to do, poor people can't.

There are questions, too, we still don't know the safety.

We've been doing it in animals.

It's not yet been done in humans, so there are going to be questions about safety and

risk, etc.

>> And how do you do the research to establish that, I think is a big question.

>> Yes, right, yep, correct, and then- >> And

if you're not mandated to do the research, will the clinics just go ahead and

do the therapy without having to do the research first?

>> [INAUDIBLE] anyway, sorry. >> [LAUGH]

>> And there's also a question, so

if this is how much money we have in the research budget,

in the federal research, most research is still federally funded, I would say, NIH.

And NIH budgets has been flat and President Trump, or

just Trump as I call him [LAUGH] has advocating cutting the NIH budget.

So if we only have this much money, how should we divvy it up?

In other words, should this be a priority?

There are those who say, well, there are children you can adopt, things like that.

These are the ethical issues just that are out there.

In other words, should this be a priority developing this versus other

areas where there are people dying of diseases, etc., etc.?

The other would be just sort of the science fiction side is let's say we

can take someone's skin cell and turn it into eggs and sperm.

Well, let's get someone's skin cells who are sitting in the audience tonight,

they left a cup here or whatever- >> They fell asleep.

>> They fall asleep.

We're all busy leaving skin cells around,

can I develop- >> Like who-

>> [CROSSTALK] Straight out of Law and

Order.

>> [LAUGH] >> So

at some point if this is the technology, can someone get your skin cells and

make basically, have your eggs or sperm in effect?

So these are questions down the line, but- >> And my last question, actually,

I'm wondering about many of our audience actually over the course of four weeks,

they always interested about stem cell treatments and locations.

And I'm just curious when one of the ethical question I come up with with

stem cell treatment was when you are designing a clinical trial,

usually you have two groups.

And one group take the treatment and the other group doesn't take the treatment.

And so you don't tell them, and they are not getting the treatments,

but they don't know about to eliminate the placebo effect on them.

>> It's a double-blind placebo basically.

>> Yes, so what I'm wondering is we will have a speaker coming out for

next week for Parkinson and they are trying to go to clinical trials.

And for Parkinson, in order to deliver this test, you need to do a brain surgery.

And what I'm wondering is you have a person who has Parkinson disease.

And you are trying to do surgery and

you are not telling if you're putting the cells in or not.

And afterwards, you have a control study, which is great on paper.

But, what do you think about ethically?

>> I'll give you a one sentence answer.

I don't think every study needs to be a double-blind placebo controlled trial.

>> Yeah.

>> Right. >> And that's sort of a larger question of

clinical trail ethics in general.

And clinical trials, some of them,

there are some sham surgeries, which is a big ethical issue.

But even some phase one, when we're talking about deep brain stimulation,

a lot of what Joe Finn's work did.

There's starting to be a lot more discussion as to whether it

is in fact ethical to do certain things like that if,

first of all, you may not get results.

You're subjecting people to extremely invasive things.

The ethical discussion of clinical trials and how you do them is moving.

So I would say that stem cell, or what you're speaking of,

is actually part of a larger ethical discussion that's starting to move

in favor of doing a little bit less of that, depending on the conditions.

>> Sometimes doing a placebo control trial will be unethical.

>> [LAUGH] >> Exactly-

>> [CROSSTALK] [INAUDIBLE]

>> Exactly, yeah, really.

>> Well, particularly if there's risk.

>> Various different scenarios, not just the one you raised.

>> Yes. >> Right.

>> Yes.

>> I would just say, so

one is many of us hope that there will be good treatment sometime soon.

It's been more difficult than many of us have hoped.

And so I think in terms of therapies based on human

embryonic stem cells, we don't have them.

But I think there's not reason to give up hope.

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