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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 human tissue. 

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 company?"

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 highest bidder.

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 cloning.

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 research.

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 avoid.

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 to it. 

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 regulate.

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 doesn't apply.

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 cell research. 

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 laws.

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 of piecemeal—

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 there.

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 that—

MS. ANDREWS:  No, I was on one dealing with the Human Genome Project, actually.

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 looking at?

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 review boards.

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, etcetera.

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 of research.

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 so forth.

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 new ones. 

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.

(Applause.)

(Whereupon, at 5:17 p.m., the proceedings in the foregoing matter were adjourned, to reconvene at 8:30 a.m., the following day.)



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