THURSDAY, July 24, 2003
Session 4: Stem Cell Research: Current Law and Policy with
Emphasis on the States
Lori Andrews, J.D.,
Professor of Law,
Chicago-Kent College of Law;
Director, Institute of Science, Law and Technology,
Illinois Institute of Technology
CHAIRMAN KASS: The last session of the day, also on stem
cell research, recent developments in law and policy, with emphasis
on the states. Federal policy governing human stem cell research
is well known to the Council.
It has been formed basically of two elements — a legislative
prohibition on the use of federal funds for destructive embryo research,
and President Bush's funding decision to support work on the
already-existing human ES lines, with some 70 lines eligible but
only 11 lines available for use.
Funding for research on adult human stem cells is unrestricted,
as is research on human embryonic stem cells in the private sector.
The Europeans, who have similar national policies, don't understand
either American federalism or the traditional distinction over here
between public and privately funded activities. And they are surprised
to learn, say, the difference between what California and Louisiana
are doing in these matters. But to Americans, the separate laboratories
of the several states are nothing new.
And to help us monitor developments in this area we've commissioned
a paper by Lori Andrews, Professor of Law at the Chicago-Kent College
of Law, Director of the Institute of Science, Law, and Technology
at IIT, who is the country's leading authority on this subject
and a prolific writer also in the area of law and bioethics, especially
in relation to ART.
It's a very great pleasure to welcome Lori Andrews for this
presentation to the Council. We thank you for your paper. We look
forward to the presentation and the discussion. Thank you for coming,
and thank you for indulging us this extra time.
MS. ANDREWS: When you were having your earlier discussion
this morning about commodities and body tissue, it made me think
of a newspaper article I had read growing up saying the chemicals
in the body were worth 89 cents.
Well, obviously, with the tens of thousands of dollars being paid
for eggs and a human gene, like the erythropoietin gene being worth
a billion dollars a year, we've entered an age of a market in
And coming after the scientific panel, talking about the many,
many uses, you can see that market could be burgeoning around embryo
stem cells. Immediately after the potential for these cells was
announced in 1998, every NIH institute put on their website what
they planned with those cells.
The Heart, Blood, and Lung Institute said it would repair failing
hearts and grow new heart chambers. General Medicine said it wanted
to grow artificial skin. And even the Environmental Sciences Group
wanted to get in the act, proposing to use embryo stem cells to
"test the toxic effects of biological chemicals and drugs."
Now, obviously, this is not without controversy, and both pro
choice and pro life advocates have particularly centered on some
of the commercial aspects of this. About a week after the announcement
in '98, I got a call from an in vitro fertilization clinic,
and the head of the clinic said to me, "We have about 300 embryos
that nobody has asked about recently. Can we sell them to a biotech
And I think this kind of goes against Dr. Kass' idea that
the people who aren't the individuals but who are making the
profits out of it have mixed their labor into it. Since obviously
this in vitro clinic had charged people to do the in vitro,
were charging them for storing it, and so they would just clear
a sheer profit on it.
But imagine the heartache of a couple who later showed up wanting
their embryo for a second child and learned that it had been sold,
and what if—you know, even if a couple had checked "research"
on their in vitro form, they may have had in mind at the
time research dealing with fertility and not something that would
turn their embryo into a set of nerve cells that was sold to the
And we've also seen instances where the couples now disagree
about the fate of the embryo. In one case, there was a divorce.
The woman wanted to use the embryo for creation of a child. Her
husband did not. But they had checked "research" on their
form, so after seven years of litigation the court agreed that research
could be done.
And as we've heard from Dr. Gearhart, there's no guarantee
necessarily that these stem cell lines will be used to cure serious
diseases. It might turn out that the cardiac cells would be used
not only to repair damaged heart chambers, but to enhance athletic
ability. Geron Corporation touts the artificial skin it's developing
as a treatment not just for burn victims but for people with sun
damage and other age-related conditions.
And, indeed, one older Senator might have let slip his real interest
in embryo stem cells when he referred to them as "a veritable
fountain of youth."
So what perspective is the law, particularly state law, taking
on all of this? I've been asked to address how existing laws
apply and affect this work, what kind of legal research might be
permissible, who should oversee it, and who, if anyone, should own
rights to the processes and the products of embryo stem cell research.
I'll just briefly go through several approaches, and then
the meat of the laws themselves.
Now, one approach that we could take, and some states do take
it, is to ban embryo stem cell research altogether and focus more
effort on the exploration of the potential of adult stem cells.
We saw from the budget put up by Dr. Gearhart that more money is
being distributed in the adult area.
A second approach — the opposite extreme could be to allow
any type of stem cell research. There have been bills proposed
on that, including the creation of embryos for research purposes,
as was done at the Jones Institute where they paid an egg donor
and a sperm donor and created an embryo for research purposes, or
at Advanced Cell Technologies, creating that six-cell embryo through
In China, such research is also proceeding, with a study of .
apparently transferring a human cell, nuclei from a seven year-old
boy into a rabbit egg.
A third approach might be to use excess in vitro fertilization
embryos. There are, as the papers show, over 400,000 such frozen
embryos, and studies show that 10 to 30 percent of them are . could
be made available based on couples interested in participating in
Again, though, there's a question about whether there actually
ever is such a thing as an excess embryo, if there are couples willing
to adopt such embryos, and also, you know, given, you know, other,
you know, concerns about the couples' interests.
Now, the states as well as the Federal Government have a role
in setting policy in this area, and 26 states have laws that govern
research on fetuses and embryos. They are enormously different,
and they vary widely on things such as whether they only apply in
situations where there's been an abortion. For example, 12
of the states only apply if the research subject was the subject
of a planned abortion.
So there's more leeway in those states to do research on a
miscarried fetus, but there are medical reasons to think that might
be less than optimal, since most stem cell research will not take
place on miscarried conceptuses but on in vitro embryos.
In that situation, we currently have nine states that banned research
on IVF embryos altogether. And what that means, though, is that
it doesn't really get to the heart of the activity. For example,
if Dr. Gearhart found that a certain type of destructive embryo
research produced a safe and effective therapy, once it passed the
experimental stage it could be done in those states. It only applies
when the activity is at the research stage.
And it has created a kind of funny situation across time where
. for example, one of those laws is in Massachusetts, and so researchers
at Harvard couldn't do certain research on embryos and fetuses,
like chorionic villae sampling research in the early stages. They
had to wait until their colleagues at Yale in Connecticut, which
doesn't have such a law, got it to the stage where it was clinical
and then it would be okay to do it in Massachusetts as well.
There are also, at least in one state, in California, a law that
permits human embryonic and adult stem cell research from any source,
including somatic cell nuclear transfer.
Now, in that state, there's only a little bit of regulation
on this being done. The research has to go through an institutional
review board, and the research can't be undertaken unless there's
a written informed consent of the embryo donor.
Now, I'm intrigued because they don't say donors, you
know, and an embryo, of course, has a male and female, you know,
part to its creation. And so it would appear that the female patient
of infertility services, the woman, and not her husband, is the
sole source of consent under the California law.
Now, if it goes forward in California, I think they need lots
more attention to issues around informed consent for some of the
reasons I mentioned earlier. Some couples who would consent to
research generally may not feel comfortable with that commercialization.
And I've seen that in another area that I work where there
are people who are willing to participate in certain types of genetics
research, but for religious or other reasons oppose gene patents,
and so are troubled with that application.
In addition, neither the California law or any of the proposed
laws give any attention to the recipient and the level of informed
consent you might need from someone who would use a therapy based
on human embryonic stem cells. Some people may not want treatment
that uses cells derived from human embryos, just as Jehovah's
Witnesses will turn down treatment involving blood transfusions.
And it won't always be necessarily clear. I mean, there was
an issue in Germany, for example, where there was a product called
Lyrodura, which people used, and it wasn't explained to them
it was made out of human brain matter—dura. And so not only did
they not understand that, but they weren't prepared for the
medical problems that happened when some of them started having
negative effects from infections passed on by it.
And I think there are other issues around informed consent and
CGD which have to do with what you tell the person you're going
to do in terms of the screening. I mean, you generally asked about
the characterization of these lines. Okay.
And so if my embryo is used for research purposes, and I'm
not told that they're going to do infectious disease screening
and karyotyping and a lot of things that might have implications
for my future health insurance, or even my future liability- I recall
when Jose Cibelli was first using purportedly a cheek scraping to
create an embryo at U. Mass.
It went through their institutional review board, and the IRB
said, "Oh, of course it doesn't apply to researchers who
do scientific studies on themselves," without thinking about
what happens if he creates a heart cell line that has some defect
in it. He'd be open to a products liability case for— potentially
for that. And so there are ways in which the donor needs information
about what's going to be done.
So Dr. Kass had mentioned that this is an area that I've studied
for a long time. In fact, the past 25 years — 25 years ago
this week I took the bar exam on the day that Louise Brown, the
first in vitro child was born, and so I've looked at,
you know, what has happened in state legislatures around embryo
research, around in vitro around fetal tissue transfer, around
germ line gene therapy, all of these things.
And I see something different emerging now. I mean, one thing
that I see emerging is this real inflated hype in kind of both directions,
in the preambles to these bills, and so forth, either promising
the moon, you know, we can do all of these treatments now, we're
going to cure every disease, to be skeptical of, or this is all
really horrible and a kind of misstatement of the science that I
point out in my paper.
I'm a little . and then, another difference I see is that
in the earlier generations of laws dealing with embryo research,
the issue was only, is it permissible, or not? Now, though, what
I'm seeing is that both states that want to discourage and states
that want to encourage put forth all of these provisions about what
also applies to contracts and liability.
You know, for example, states that don't like cloning sometimes
have in their laws liability provisions that say if anything's
wrong with the clone, they can sue, you know, their parents, the
doctor, everybody else. And states that like embryo stem cell research
actually already have liability provisions being suggested and in
place that would make it harder for someone who does have a real
problem with the stem cell research to sue.
So in terms of the restrictions that are in place . that are being
proposed as opposed to the ones that are in place, 22 states have
bills currently being considered that would ban therapeutic cloning,
and nine states have bills that would allow it. And some of those
bills that would allow it . I mentioned Kentucky in my paper.
You know, you just give $50 to register that you're doing
this, and kind of that's the oversight as opposed to some sort
of regulatory structure that might deal with the safety of it.
In addition, four states have bills that would prohibit acts where
the human fetus or embryo is destroyed or subject to injury. So
a parallel to the federal law and would ban embryo stem cell research
as a subset of that.
Ten states have bills that would allow embryo stem cell research
from any source, and they often say human embryonic stem cells,
human embryonic germ cells, human adult stem cells, somatic cell
nuclear transplantation. And those that want to encourage it, there's
a small subset of about five that have thought through at least
a few of the issues.
How would this work kind of on an industry-wide basis? And they
have proposed provisions in these bills that talk about what the
responsibilities of physicians are to inform couples in in vitro
clinics of this possibility.
Some have . five states talk about institutional review board
approval. One would have all proposed research assessed by a state
committee. And 11 states have bills that really are more study
bills. They would establish a subcommittee to think about these
issues much as you're doing at this moment.
Now, my paper also points out that not all of these laws are necessarily
constitutional, if you ended up going to court as a scientist or
other individual who was limited. And remember the state laws that
are in place, like the nine states that ban embryo research, apply
no matter what the source of funding is. So it's very different
than the federal law hinging on federally-funded research.
And some of these laws have been challenged. In Arizona, Illinois,
Louisiana, and Utah, there used to be embryo research bans that
got knocked out. And why did they get knocked out? Because they
are criminal laws, and under criminal law you have a right to notice
. a sufficient notice about what behaviors you're supposed to
And something that just says it's a crime to do embryo research
doesn't give sufficient notice. I mean, think about it. If
I'm an obstetrician and I'm treating a pregnant woman for
asthma, and I don't know the impact on her fetus, that could
be viewed as, you know, criminal experimentation on a fetus.
Or if I'm an in vitro physician, and I use a different
medium in the petri dish, that could be research on the embryo.
So it's just too vague.
Now, you can get around that in some of the new generation of
bills that are being proposed that specifically say you cannot do
somatic cell nuclear transfer to create a human organism and use
it for stem cell purposes.
Now, policy obviously can tremendously affect what science is
taking place, the scope of research, access to research results,
and the rights of the participants. And I think the law can play
an important role in this area in terms of creating a sense of trust
in people, no matter what your decision is. And I don't see
that any of the proposed laws going either way have the ability
to do that.
And I think of all the in vitro physicians who have said
to me across time, "Oh, I'm so glad I'm not in the
United Kingdom, because they have all those horrible rules about
review, and they have that Human Fertilisation and Embryology Authority,
and it's just too cumbersome and clumsy."
But then, what happened was that I think that system in place
created a sense of trust where when the embryo stem cell research
issue came along there was more of a willingness to go forward,
because the public at large there didn't feel it was, you know,
in such a state of laissez-faire as in the in vitro situation
in the United States.
So we're hearing this brain drain to actually a culture where
science is more restricted, but I think has created a sense that
at least someone is watching over it. And I don't see that
any of the proposed bills are sufficiently detailed in either direction
to give that, you know, sense of trust.
So I'll open it up for questions.
CHAIRMAN KASS: Thank you very much. The floor is open
for discussion. Michael Sandel.
PROF. SANDEL: Well, this is a question for our speaker
as well as the other lawyers in the room. Would a federal ban on
cloning—put aside even the debate about reproductive versus therapeutic
cloning, but a federal ban on reproductive cloning even, would that
be constitutional? Is that a federal function?
MS. ANDREWS: I think it is, and I would say that when
. I'd say 10 years ago there would be more hesitation to my
answer. But looking at how courts are ruling on things like the
Americans With Disabilities Act, and whether it applies . and natural
law, whether it applies, for example, to a dentist who only practices
in his own state, and so potentially there's no interstate commerce
And in decisions like that, the federal courts have said, you
know, if you're in an area where it's . it deals with people
coming from other states to get the services, it deals with doctors
who go to seminars in other parts of the country or are trained
in other parts of the country, there's enough of an interstate
commerce issue to make it an area of federal reach.
Then, the second question would be: does it interfere with reproductive
liberty if you ban my right to clone myself? And I would argue
that reproductive liberty does not cover it, much as the argument
was made by Dr. Kass earlier that it's hard to think of natural
law covering carrying someone else's child.
But even if it did cover it, and certainly in California right
now there's someone who wants to challenge the California ban
on reproductive cloning on the idea that it interferes with his
reproductive liberty, you can nonetheless still sustain a ban if
you show that it furthers the compelling state interests in the
least restrictive manner possible. And I think the dangers physically
are high enough that you would meet that, so I see no problem with
a federal ban.
PROF. SANDEL: I wasn't thinking of the reproductive
liberty issue, which I agree could be raised.
But strictly on federalism grounds, Mary Ann, Rebecca, do you
agree with that, that it wouldn't be a controversial constitutionally
. no, I mean, it wouldn't be a live case.
PROF. GLENDON: That's a different question,
whether there would be a case, whether it would be controversial.
But I think Lori's analysis is correct.
MS. ANDREWS: You know, the same way the Food and Drug
Administration can regulate . I mean, if you look at some of those
decisions, and lots of times drug makers in individual states try
to challenge it, and they say, "We only have used things from
within our state."
And the court decisions say, "Listen, you know, you're
using a glass vial or the adhesive on the back of your label comes
from another state," and so in that sense I think you could
CHAIRMAN KASS: Mary Ann Glendon.
PROF. GLENDON: On the vagueness argument, the
constitutional argument based on vagueness, were those old statutes
that were struck down in those four states? And are there examples
of statutes banning certain kinds of embryonic research that are
drafted so as to resist that kind of challenge?
MS. ANDREWS: They are exactly the same language that was
struck down as exists currently in the nine states that banned embryo
research, you know, because they basically . those statutes just
talk about it in those terms—embryo or fetal experimentation.
So these are states where it hasn't been challenged. And
where it has been challenged they were— it was struck down as
too vague. I think if you described more what process you choose
to ban, as some of the states do with the reproductive cloning bans,
one of the problems with that, though, is you sometimes get too
narrow, that people can invent around it.
You know, so like the statutes that say, oh, you can't put,
you know, somatic nuclear material into a human egg, then if someone
comes along and puts it into another mammalian egg, it—the law
CHAIRMAN KASS: I have Gil, Rebecca, and Frank, in that
order. Gil Meilaender.
PROF. MEILAENDER: Lori, can you say a little bit about
what you think the significance of these proposed laws might be?
And at least one thing I mean by that is this: if we look at your
chart, in relatively few cases are there laws actually that have
been enacted. Mostly what we have are laws that are proposed.
It wouldn't be that—it's not that hard to propose a
law. In a way, that can happen, and it can have no chance of going
anywhere in one or another state legislature.
So do you—I mean, do you sense any trends, for instance? Is
there anything that you would conclude from what you've put
on the chart, other than that, you know, quite a few states are—in quite a few states there is at least somebody who is interested
in the question.
You know, I don't know quite what we should conclude from
this, and probably nobody can know for sure. But anything you could
say about it I would be interested in hearing.
MS. ANDREWS: Yes. I mean, I think the more interesting
things are just to assess what the motivations might be behind these
laws. And, you know, if we're concerned about an ultimately
important interesting legal outcome, how to deal with those motivations.
And I think that, you know, there are a number of states that are
just saying, "We want to be a biotech haven."
And so unless you take on straight away, you know, kind of what
fundamentally do we want out of our technologies, and so forth,
you're just going to see a sort of crazy quilt of proposals
that are saying, "Biotech, come to us."
You know, on the other hand, on the other side, there are laws
being proposed that are, you know, part of a packet of a pro life
agenda. And so it's really—it's about that, and it's
really not so much about this particular technology—embryo stem
I mean, I see the same thing going on at an international level.
When I'm in other countries, you know, like France they'll
say, "Oh, we hate, you know, what you're doing in the United
States, and we think you're getting us down to the least common
ethical denominator about gene patents and stem cells, because of
the GATT treaty."
At the same time, these same people are, you know, wanting not
to lose any chance for the biotech dollar.
CHAIRMAN KASS: Rebecca.
PROF. DRESSER: Two questions. One is, I wonder if any
of the bills that are in California—I looked for this a little
bit, the law that was passed that wants to permit research cloning,
if any of them have anything in there about the oocyte providers,
and who is going to be deciding how that should be arranged, and
the payment issue, and so forth.
And the second question was: have you seen any groups or individuals
trying to work on, say, a model statute approach with alternatives?
You know, if you like X, don't like Y, here's what you could
do, similar to what I think it was the ABA did with surrogacy.
MS. ANDREWS: I haven't seen that approach in model
laws, although I've seen it a lot with reproductive technologies.
And maybe if I go back over those, I'll—I think all they say
about research is giving people the choice to donate to research
or to have their embryos terminated or to give them to another couple.
There is a lot of law on the banning of payments to the egg donors
or providers of embryonic or fetal tissue. There is less concern
for quality of consent or monitoring. You know, if you made a market
in this, monitoring the effects of Lupron or other fertility drugs,
and so forth, and I think that that's an intriguing problem,
even at the federal level with the Food and Drug Administration.
Once it gets into this therapeutic model, this whole area of embryonic
stem cell and embryonic tissue is treated as if these were drugs.
So the whole focus is kind of on the safety of the recipient, if
you look at proposed FDA guidelines. Are infectious diseases going
to be passed on? And so forth.
There's very little attention paid to safety issues around
the donor, or even disclosure issues, and so forth. So I think
that's a big—perhaps because we're uncomfortable with
the human source of it, you know, we're just pretending this
is like any other pharmaceutical product, without looking at, you
know, the implications on the donor.
CHAIRMAN KASS: Frank Fukuyama. I'll follow you, Frank.
PROF. FUKUYAMA: Professor Andrews, could you say something
about the ability of the FDA to accomplish what the state laws are
trying to do, given its existing statutory authority? Because we've
heard from a number of fairly authoritative sources that, in fact,
the existing statute would allow them to do that.
For example, although they typically don't regulate procedures,
they do regulate medical products, and there's no IVF clinic
in the world that doesn't use medical products of various sorts.
And so if they interpreted their statute in a certain way, they
could in fact, you know, extend those regulatory powers. And the
primary reason they don't is just a prudential political judgment
that the country doesn't want them to do that.
But, you know, in terms of their legal authority, that's—you know, that would be perfectly possible.
MS. ANDREWS: Well, one of the difficulties is that their
focus is on safety and efficacy, so they have pretty—you know,
they have a really broad range. I mean, they could use—do more
with the authority they have under certain of the public health
You know, but certainly this is an area where people have concerns
far beyond safety and efficacy, and that's where the FDA is
not going to provide guidance either by its temperament in having
talked to people there, you know, and asked, you know, for guidance,
and also by their mandate.
And so to the extent that society wants to make a decision that
says, you know, we don't potentially think the benefits of this
particular—you know, some aspect of this technology are worth
running roughshod over other values, it's not going to be the
FDA that can say that. They can just tell us, you know, if you
go ahead, what would the implications be for human health.
PROF. FUKUYAMA: If I could just follow up. But if they
wanted to, for example, ban reproductive cloning in effect on safety
grounds, I mean, wouldn't they be able to do that?
MS. ANDREWS: In part it depends whether a medical organization,
like the American Society of Reproductive Medicine, argued that
it was a procedure. You know, they can't regulate medical procedures,
and so a lot of unsafe surgery is going on, and sometimes for years
on end. But the FDA can't step in.
And so that has been part of the problem. I mean, in fact, when
the FDA first said, "Oh, we have the power to regulate human
cloning because it could be—you know, there could be genetic problems
in the offspring, and, you know, there's this manipulation at
the lab," everybody said, "Well, why haven't you been
regulating IVF," which has those same problems.
And there was considerable, you know, concern that this exception
for medical practice, which they can't regulate, could be used
in a way to swallow it up. So, I mean, I think they have more power
than they've traditionally exercised, but that's where the
conflict would come up.
CHAIRMAN KASS: We've given you a narrower assignment
than you could manage. That is to say, we've asked you to talk
about the legislation on stem cell research, and, of course, it
is in some cases tied up with cloning, both for producing children
and for biomedical research.
And to tie this in with the Council's own inquiry, which we
will visit again tomorrow, on the aspects of oversight monitoring
and regulation and the whole area of the confluence of ART and the
growing genomic knowledge, we've in a way been trying to think
about this area as a whole rather than piecemeal, cloning here,
stem cells there, though it looks like in most of the state laws
that we have either on the books or proposed they are responses
to the latest threat that's perceived by somebody either to
their interest in going forward with the research or to the embryonic
life that they seek to protect.
And I guess one question is: is it at all feasible to think that
the states might be laboratories for more comprehensive treatment
of what the people are now starting to call reprogenetics? Or this
whole area of which stem cell research is but a piece, ART is a
piece, PGD is a piece, and things of that sort. Or is that something
which, if to be considered at all, is something to be considered
federally? That would be one question.
And the other—and I think we can figure out why the current
new state laws—people being frustrated at the prospects of enacting
something federally are going into those states where they have
the best chance of winning and pushing through either Louisiana
or California, or everything in between.
So it might very well be that these are the kinds of issues, precisely
because of the issue of the embryo in the middle, that are not easily
amenable to compromise. You don't balance if one side holds
something as a matter of inviolate principle and right. It doesn't
enter into a balance.
On the other hand, comments that you made about you don't
see any place where the people interested in protecting human dignity,
and the people interested in having the research go forward, sit
down together in some state and try to work out some kind of a package
that is the best possible arrangement here in Kansas, or some other
place, do you think that because of the intractability of the embryo
question it's out of—it's unlikely to try to develop some
kind of collaborative efforts in which industry and the people who
are worried about where this is going could collaborate on some
kind of state regulatory activity? Or is that just a pipedream?
That was really two questions, rather long-winded.
MS. ANDREWS: No. I think that is a possibility, because
I do think there is more consensus if you start, you know, in some
other area. Even if you start from a question like, what do you
do in a divorce with frozen embryos, and, you know, something that
hasn't been as—you know, where sides have built up the sort
of animosity that they have around the abortion question.
And I think that there are some states—and I'm trying to
think—maybe Virginia, Florida—on reproductive technologies generally
where they've created more detailed laws. They've tried
to think about all of the different, you know, possibilities of,
you know, diagnostics and of different combinations of parents,
and kind of work it out a little bit in advance.
One of the problems at the state level, though, is that even well-meaning
lawmakers who have gone into that sort of approach find out this
is unlike, you know, regulating the roads or insurance, because
everybody has an opinion about how the next generation should come
into the world.
And there's no political gain from ever taking a position
on this. So I think that's, you know, one observation of legislation-watching
for a long time on these issues.
The other observation is that it takes some huge public event
to really push an issue. For example, there are lots of states
that had really interesting, very comprehensive surrogate motherhood
legislation working through the pipeline before the Baby M case.
But nothing got adopted, and then, you know, this case came to the
fore of a surrogate changing her mind, and then quickly states adopted
laws that just dealt with that situation.
So when other situations came up where nobody wanted the baby,
instead of everybody, they didn't have anything to cover it.
And so I really think—and I fear for our biomedical policy in
that sense, because I know that the policy we get on, say, you know,
certain gene therapies is going to be based on whether we have some
horrible case in the media or some wonderful case in the media.
And that's not really the way to think these things through.
But, I mean, I do think that the part we have—I guess what we've
talked about is a bioethics fire drill. A new technology comes
around, and we all run around and try to deal with it, rather than
thinking through the various possibilities and trying to do this
collaborative effort to deal with it.
CHAIRMAN KASS: Could I follow on just briefly? As I listened
to your answer, it makes me think that it's even more unreasonable
to expect such collaborative and far-sighted and thoughtful effort
in the states.
MS. ANDREWS: I think—
CHAIRMAN KASS: What's the incentive there for people
in the states to sit down and figure out, you know, what the state
policy overall in reprogenetics ought to be? Aren't they likely
to react only when something like this happens? Think some kind
MS. ANDREWS: It's hard. They don't have the staff—staffing available. But that's the perfect situation for
the sort of —
CHAIRMAN KASS: The models.
MS. ANDREWS: —model—
CHAIRMAN KASS: Yes.
MS. ANDREWS: —law to come along to say, okay, we've
thought about all of these things. And I certainly think in the
overall issue of different biotechnologies that are on the table,
there is getting to be a growing interaction between people who
have previously identified themselves as pro life and pro choice,
who are waking up and saying, you know, let's put abortion off
the table, because we're going to lose a lot of ground with
human dignity and human life if we just let the people who are commercially
benefitting make all the laws, while we're busy, you know, shooting
across the barricades on this other issue. So I see big movement
CHAIRMAN KASS: Janet Rowley.
DR. ROWLEY: It's my impression that you were on one
of the panels, if that's the proper term, at NIH over the past
decade that was looking at the issues about embryo research. Is
MS. ANDREWS: No, I was on one dealing with the Human Genome
DR. ROWLEY: Okay. Because what I was—the question—and it's been alluded to—that we are trying to figure out
where to go next on this issue. And there are some of us who feel
that—I think everybody agrees that there needs to be some sort
of oversight body in addition to the IRBs.
And then, the struggle is, would this body be best housed, say,
at NIH? Should it be a higher level Health and Human Services issue?
Or is this the kind of thing that you need a Presidential commission
And so I was just wondering whether in your experience in considering
some of these issues whether you have any advice for us.
MS. ANDREWS: My advice would be not to put it at NIH,
you know, just because of the potential conflict of interest when
you've got sort of every institute there saying, "Well,
we'd like to, you know, do all of these techniques. You know,
we'd like to do gene therapy. We'd like to do embryo stem
cell research." There shouldn't be any constraints on
what we do.
I mean, it is sort of, you know, the fox guarding the chicken
coop, so I would suggest that, you know, at either at the higher
level, at the Secretary's office. And it is an important, you
know, issue, much as we were talking about with the Food and Drug
Administration. You've got these regulations that apply to
federally-funded research that specifically say that IRBs are not
to consider the long-range effect of the research.
And so you do need some other body potentially saying, you know,
is germ line genetic engineering on embryos, is sex selection of
embryos appropriate or not, because that's precluded from consideration
in part under the existing—you know, from consideration by institutional
DR. ROWLEY: Can I follow up on that? Because some of
us, myself included, have thought that the Recombinant Advisory
Committee, the RAC, was a potential model, and that's an NIH
committee. So you're saying that isn't the model that you
think might be wise to—
MS. ANDREWS: You know, I don't think so—I mean,
the RAC occurred before NIH itself started adopting, you know, based
on the 1980 laws that said NIH researchers can patent their findings
and make an additional $150,000 a year based on their patents, and
they could form biotech companies, and so forth.
So there are ways in which the NIH itself—you know, unlike in
the early days when the RAC was formed, now our—you know, have
some of the same commercial motivations in a way.
DR. ROWLEY: Well, but I was thinking that though the—such an oversight body might be within the purview of NIH, I wasn't
thinking that any NIH members would actually be part of that. It
would be more, as the RAC is, external scientists and lawyers, ethicists,
MS. ANDREWS: In part, it just I think makes sense as an
institutional structure to make sure it's, you know, staffed
elsewhere, though. You know, if you staff it by NIH people, you
know, volunteers that meet once a month or, you know, so forth,
I mean, they ultimately, you know, may not have the last, you know,
say in it if the day-to-day recommendations, and so forth, come
out of an entity that really wants to go—you know, would not like
to be encumbered by problematic regulations. But that's just
my personal experience—
DR. ROWLEY: Okay.
MS. ANDREWS: —from my own, you know, experience at NIH.
CHAIRMAN KASS: Comments? Questions? I want to ask—some of us attended a meeting a week ago, a seminar that Frank Fukuyama
is running on this whole area, and the professor of law at a local
university was in fact—the question was: what are the constitutional
obstacles to regulation in this area?
I'm going to revisit the question that Michael Sandel asked
you earlier, where he was dealing with the question of Congress's
power to enact legislation, not so much the constitutional protections
that such legislation might violate.
You alluded to the possible claims in reproductive rights. This
lawyer, who was practicing creative legal thinking to see what might
be done, suggested that there might be, in an expansive understanding
of the protection of freedom of speech, understood as expression
and understood as fatly as you'd like, some kind of claim that
scientists might bring under the First Amendment a complaint that
laws restricting research in any area, for whatever reason, was
a violation of what?
MS. ANDREWS: Of the First Amendment.
CHAIRMAN KASS: Yes, the First Amendment.
MS. ANDREWS: Sure.
CHAIRMAN KASS: Very broadly conceived.
MS. ANDREWS: Yes. I can comment on that.
CHAIRMAN KASS: I don't want to encourage such thinking,
but do you have an opinion?
MS. ANDREWS: Yes. You know, we are under the First Amendment,
freedom of speech, there is the idea that it not only protects speech
itself, but the precursors of speech, so the funding, you know,
of—and the gathering of news, whether you go into prisons, or
whether you—you know, that sort of thing, or campaign funding,
and so forth.
So you could make the argument that doing science is a precursor
to having a marketplace of ideas. How can we talk about things
if we don't generate the research to do it? And there are some
cases that talk about it.
The most prominent one has to do with whether the Kinsey Institute
at Indiana University can—researchers there can look at pornography,
you know, things that are considered obscene, or whatever, or does
that interfere with their right to research.
And it was held that they could, you know, look at this, because,
you know, and so there's some—there's even some low-level
case law in addition to the theory.
Now, people have tried that argument with respect to fetal research,
for example, and courts have, you know, sort of slapped them down
in terms of saying, you know, freedom of research is one thing,
but there's also the need to protect the subjects of research.
And so, you know, virtually any regulation that you can come up
with that promotes safety, for example, would not run afoul of freedom
CHAIRMAN KASS: Okay.
MS. ANDREWS: And so it's basically been interpreted
to be allowing people access to existing materials, and so forth,
not cutting off what's there, but in terms of generating new
knowledge in a way that might be risky, it doesn't apply.
CHAIRMAN KASS: All right. Anyone else?
MS. ANDREWS: May I add another legal comment that we haven't—
CHAIRMAN KASS: Please.
MS. ANDREWS: —addressed? And this has to do with the
sort of fruits of the research in the sense of the issue of patenting.
And I think that is going to play an important role ultimately in
what happens in the embryo stem cell area and touch on all of the
issues you were dealing with this morning, in terms of access, and
The approach of the President of allowing access to existing stem
cell lines obviously has an impact on accessibility in terms of
the fact that most of those stem cell lines are owned and patented,
and so forth, by particular entities.
And even though there has been access allowed to some of them
for, you know, not horrendously high fees, there are still these
intellectual property reach-through rights. So what's happening
is that, okay, I'm percolating along, maybe I'm a scientist
who is, you know, trying to develop, you know, nerve cells.
And I might come up with something really, really fabulous. But
the owner of the—you know, depending on the reach-through agreement,
that original owner can then say, "Well, you have no right
to make it; we kind of own what you've ultimately done."
And I think that's problematic.
I think there's not only the issue of sort of taxpayers paying,
you know, what some have estimated as, you know, 40 percent of the
costs for the intellectual property rights to use stem cell lines,
that's a cost that you wouldn't have if people could generate
But, you know, there's also a real issue—and it resounds
with me, because I'm seeing it play out in the gene patent area,
where you're not supposed to be able to have patents on products
of nature or formulas, and a genetic code seems to be both.
And now we're seeing researchers being prevented from looking
at a gene sequence because some other company or institution owns
that gene sequence, or people being detoured entirely from going
into a field because the idea is, why should I spend all of this
time when I'm not secure that I—you know, when an ultimate
pharmaceutical product, which clearly should be covered by a patent,
comes out, you know, it's unclear I'll have rights to it.
So I would say significant problems are developing in the gene
patent area in terms of access to diagnostics and in terms of research.
I would—you know, you're a little earlier on in the embryo
stem cell area, but I would alert you to those. I mean, that's
a legal issue that will have an enormous, enormous impact.
CHAIRMAN KASS: Thank you.
Frank, and then I think we'll probably wind up.
PROF. FUKUYAMA: Well, okay. I just want to go back to
Leon's earlier question and follow up. It's not—the lawyer
in question was Steve Goldberg at Georgetown who was talking about
these constitutional issues. I don't think that he was so much
advocating that you could declare, you know, that there was this
constitutional issue, he was just trying to—he's like a lawyer.
He's trying to make the best legal case you could.
But one thing that he said on the other side is that the interest
of the people—you know, the power of the interest of the people
that are trying to ban cloning, in this case the House bill, also
has to be taken in account.
And the law was written in a very narrow way, such that the primary
objection was essentially a moral objection rather than the health
of, you know, a child or, you know, other kinds of—or safety or
efficacy, other kinds of issues that they could have picked. And
that the trend in court decisions—and he thought that this recent
Texas—you know, the striking down of the law, the Texas sodomy—homosexual sodomy law, was important in that regard.
And I guess Justice Kennedy has played a big role in this, is
in saying that although we take seriously moral claims, you know,
these purely moral claims made in the community, that those by themselves,
you know, cannot be written into these laws.
And that was the reason—and he thought that this is a broader
trend in I guess a kind of enshrining of a certain kind of moral
relativism, you know, into American constitutional law. And that
given that, if that's the only basis on which the law is being
enacted, then that's not a very powerful counterweight to whatever
potential, you know, constitutional claims, First Amendment claims
are being made on the other side.
Could you comment on that?
MS. ANDREWS: Sure. Well, you have two things going on.
I mean, first, unless you're protected by some fundamental right,
and so that would occur if you're dealing with a particular
category we protect, a category based on race or religion, and so
forth, or a particular sort of activity we protect—speech, you
know, reproductive liberty, and so forth—and I don't really
see an indication there's enough court cases that don't
find scientific inquiry to be one of those that probably wouldn't
find human reproductive cloning to be one of those.
You know, and if you don't—if you're not in one of those
fundamental categories, then states can enact laws even if it just
is for a moral, you know, reason, or they can enact zoning laws
that say I can't paint my mailbox purple or, you know, whatever.
And so you'd have to make—you'd have to first get in
that category. I think you're right, once you're in that
category, if we had societal accord, and we had a Supreme Court
who might say reproductive cloning is a fundamental right, then
if we got to the stage that—where you didn't have the physical
or psychological problems—and it doesn't matter if the law
itself said it, because lots of time legislatures, when they get
into constitutional fights, say, "Oh, we really meant this
to do this for protective purposes."
So it doesn't have to be on the face of the law. You know,
if you got to that—that stage where it was a fundamental right,
maybe we all became infertile, it was the only way to, you know,
carry on, and it was all of a sudden safe, really safe, then moral
arguments wouldn't be enough. So once you're protected,
you know, you're right.
Thank you all for letting me attend.
CHAIRMAN KASS: Thank you very much. Thanks very much,
Lori, for your work on the presentation and the discussion.
Tomorrow morning we will meet at 8:30. We have two sessions tomorrow,
and then a public session. We should wind up not long after 12:00.
We're adjourned. Thank you very much.
(Whereupon, at 5:17 p.m., the proceedings in the foregoing
matter were adjourned, to reconvene at 8:30 a.m., the following