Senate Commerce, Science and Transportation Subcommittee on Science, Technology and Space Holds Hearing on Human Cloning

WYDEN:
Thank you, Mr. Chairman. And I'm certain we're going to have a good hearing because you have always been very fair. And I will tell you, having chaired this subcommittee in the last Congress, I wish I didn't have to turn over the gavel right now. But I look forward to working with you and know we're going to find common ground on a host of issues. And I will tell you, I don't think there is a more exciting subcommittee in the United States Senate than this one. And I wish you well.
Mr. Chairman and colleagues, first and foremost with the hopes and aspirations of millions of Americans suffering, I just hope that Congress will follow the route of careful science here rather than create roadblocks of resistance when our scientists try to come up with breakthrough cures. And I think it's especially important to reflect on another matter that we faced about 30 years ago, which has an awful lot of parallels to what we're dealing with today. In the late 1970's when recombinant (ph) DNA technology was being developed, Congress was pushed then to consider a ban on all research on a field that was considered new and controversial. You know, there was a debate, and much of the same set of questions we're faced with now was raised then.

But fortunately, the research was allowed to go forward, was done carefully, as I have suggested therapeutic research must be done now. But the benefits have just been extraordinary. And I'll just mention a few of them, a few of the 66 recombinant (ph) DNA products have helped tens of millions of patients worldwide. Humalin (ph) and humalogue (ph) served human insulin for over four million diabetes patients worldwide. Receptin (ph) treats breast cancer, is now being treated in phase three clinical trials. Epagin (ph) has been used since 1989 to fight anemia in kidney dialysis patients. Enbro (ph) works with the body's immune system to control inflammation. Pulmazime (ph) has prevented childhood deaths from cystic fibrosis.
And I think when you look at these kind of complicated scientific questions where passions do run very high, and people have differences of opinion, it is important to look at these historical models. And I just am convinced that making sure that we didn't stop scientists in the 1970's and we don't stop scientists now is critical.

Last session, the Senate looked at two very different approaches to regulating yet another unfamiliar line of research. One of them would have banned reproductive cloning while allowing scientists to continue promising research on somatic cell nuclear transfer. The other approach would have banned, not only reproductive cloning, but also nuclear transfer and the importation of medical advances made through this research.

I favor the first approach. I think it is absolutely critical if we are to unlock the next generation of life saving medical treatments. I hope that this Congress will not turn a blind eye to the therapeutic potential of the research that can lead to these breakthroughs. And I know that with strong differences of opinion, Chairman Brownback is going to handle a difficult issue fairly. And I look forward to working with him and our colleagues.

WYDEN:
Thank you, Mr. Chairman. I'll be brief. But first thing I'd like to do, Mr. Chairman, is ask unanimous consent to enter into the record a set of letters from a whole host of scientific and medical organizations that are in support of therapeutic research and make that part of the record.

BROWNBACK:
Without objection.

WYDEN:
Gentlemen, thank you. And I know you both have spent a lot of time on this issue. And as I indicated in my opening statement, I know that views run passionately on this subject. And I think my question—and I have just one—would be for you, Mr. Toomey on this question. While the science isn't going anywhere, and it's not going to produce any big gains. Let me just read you a sentence from just one of the letters from physician and scientific groups that I'm putting in the record today.

This is from the American Society of Hematology. It was written just a few days ago. And I'll quote here. It says, "as an organization of physicians who care for desperately ill patients and scientists devoted to understanding the basic mechanisms of disease and discovering new therapies, ASH is excited about the enormous potential of all avenues of stem cell research and related scientific mechanisms such as SCNT."

Now this is from a very renowned organization, a group of physicians who are considered leaders in the field. And my question to you is when a group like this says that the research is very promising—and also in the letter, they talk about how important it is to have rigorous oversight and careful procedures to make sure that the work goes forward.
Why is it appropriate for the United States Congress to say that that research shouldn't go forward when they are talking about the need for rigorous oversight, careful scientific procedures so as to not promote abuse? Why shouldn't the Congress let the scientific research go forward when there are the kind of safeguards? And they're against human cloning as I am as well. Why shouldn't that science go forward, Congressman Toomey?

TOOMEY:
Well Senator, thank you for that. And the fact that the opinion of these physicians needs to be carefully considered. That's an important part of this discussion. But I think that their opinion doesn't—and even their hope for rigorous oversight doesn't change some fundamental features here, some fundamental facts.

And that is that the product, the pursuit of what they are advocating means creating human life with the intent to learn from it and then destroy it at some period of time. And that's very troubling on an ethical level for many of us. And I think it's quite appropriate for Congress to make a judgment as to whether or not that ethical consideration outweighs the potential, the possibility that there may—although there may not—be medical benefits from this.

And we also have an obligation, I think, to weigh carefully whether it is really, truly possible to provide the oversight that they say they would like to see. As I've cited in my testimony, I think there are some very serious technical hurdles that may not be possible to overcome in terms of preventing the kinds of abuses that I think and many of us think would inevitably occur.

WYDEN:
I would also put into the record at this point, Mr. Chairman, a piece in the Wall Street Journal by Virginia Pastrell (ph) that talks about why it would be a mistake to impede medical progress. She would certainly be considered a conservative in terms of her political perspective. And she also talks about the need for rigorous oversight.

And says in response to what Congressman Toomey said the small possibility of reproductive cloning does not justify making a (ph) nucleus transfer a crime. And goes on to say how virtually anything in science—and these are her words—could be translated into evil at some point. But I think good people like you and Senator Brownback and I can find ways to minimize that prospect.

And I thank you all. I know you're very sincere in your views and look forward to working with you. Thank you, Mr. Chairman.

WYDEN:
Thank you. Thank you, Mr. Chairman. And thank you, Dr. Cass. I know you have done considerable work in this field. And I think you know I have an interest in this as well stemming from having authored the fertility clinic legislation which is still the only federal law on the books now with respect to fertility.

My first question, I just want to be clear on one point. The United States Senate, by my calculus is going to have a vote on the floor of the Senate before too long on an outright ban on cloning for biomedical research. That's what the vote's going to be. Now you are the chairman of the president's council on bioethics. My assessment is that a majority of the president's council on bioethics does not now support an outright ban on cloning research. Is that correct?

CASS:
It's a close call, Senator. On one way of reading the evidence, I think you're right. That table that you're pointing to is a table which is a table which reports the views of the individuals if the question were on that issue alone. It's a subtle point. The question is if the question was only what would we approve or disapprove cloning for biomedical research, seven were in favor of allowing it to go forward, but only under very severe restrictions. Seven were in favor of banning it. And three would be in favor of a moratorium.

There is no specific count in there on what people think with respect to the packaged bill where for reasons that have something to do with the likelihood of increasing the risk of cloning to produce children from allowing that research to go forward, where the count would be. That was on the ethics of the matter, not on the final question. I think the only thing you can go on with respect to the final opinion is that at least the majority of the president's staff favors a ban, permanent ban on cloning to produce children and says that there should be no human cloning of any sort at this time, at least for four years.

WYDEN:
I just want to make clear that I think when you read this—and I'd like to make this part of the president's council on bioethics report, Mr. Chairman, July, 2002, at page 202, it is very clear to me that a majority of the president's council does not support an outright ban. And Dr. Cass has made a point to put it in the context that he thinks is appropriate. And that certainly is right. Let me move (ph)...

CASS:
Senator, could I just ask just to read the—the paragraph before it indicates it's the restriction. I'll just refer you to (inaudible) ...

WYDEN:
Fair enough.

CASS:
(inaudible) manipulation (ph).

WYDEN:
Doctor, recently several important congressional supporters of an outright ban have made an important change with respect to their proposal. And they have indicated that they now are willing to allow the importation of products from SCNT research coming from overseas. Now in my view, this just undermines a basic proposition of the supporters of the ban's case. I mean, they have been saying again and again this is not going to produce any great scientific dividends. And yet, now they've made this major change, I gather, to pick up support. And I mean, isn't this change an admission that there are potential medical breakthroughs and they want to get the products from overseas?

CASS:
Three points. First of all, you could read that entirely the other way. There (ph) being some great doubt as to whether there are going to be any benefits, there's no point to stand in its way. Second, I think that the provision was a piece of—I had better be careful. I think it was a misguided provision of the previous law. I think it was sufficient unto the day. The important thing is not to aid and abet immoral research. And if you regard this as immoral research, sufficient unto the day is not to allow the immediate product, which is to say the cloned embryos to be made somewhere else and then used here.

WYDEN:
But that's exactly what they're doing. I mean, to me it makes (inaudible) mockery out of the exercise.

CASS:
I'm sorry. I haven't seen the next text, Senator. I think the importation provision of the bill that passed the House was not about the immediate product, but it had to do with even any kind of derivative drugs or things like that someone might some place produce. And it seemed to me what seemed to be to say that you would 50 years from now or 100 years from now not import a drug that might, in fact, aid juvenile diabetes because it came from a cell line that 50 years earlier had been created from a cloned embryo would not be regarded as somehow having been complicit in or aided and abetted in or encouraged the original evil. So I don't think that provision was necessary. I'm happy to see—if it's really going out, I'm happy to see it's out. And I don't think it's an undermining of the principal that led people to oppose it.

The most important thing it would be to me is something like this. You want to stop cloning to produce children. What's the most effective way to do that? What's the only effective way to do that? You stop that process before it starts. Now as Dr. Weldon said, if it should turn out after extensive work in animals about which I think we have to remain very skeptical—if after decades—and it's going to take decades to produce any evidence—they show us that there is a unique benefit, a unique benefit from stem cells from cloned embryos, we can revisit this question.

WYDEN:
Well, ...

CASS:
But for the time being, we are opening Pandora's box in the direction of genetic manipulation of nascent life. We are allowing the creation and the perfection of techniques of cloned embryos with the hope that we can then somehow stand in the way of keeping cloned babies from being born (ph). For what? For a pipe dream.

WYDEN:
Well, ...

CASS:
For a pipe dream.

WYDEN:
... you are saying revisit it. And all of these suffering Americans say they can't afford to wait. All of those with Parkinson's and Alzheimer's and these dread diseases, they want to see the federal government get behind them. They want to see the federal government go out and push as hard as it possibly can to find these cures. And I just think it's unfortunate that—I have enormous respect for you.

And I'd like, if I could, Mr. Chairman, ask about one other question that Dr. Cass is familiar with in terms of in vitro. But I think to have someone like yourself say, Dr., we can revisit it some other time down the road when people like myself will meet you more than half way with respect to safeguards—there's no debating the need for the safeguards. And there's no debating the fact that we are going to support the ban on human cloning. But with that ban, plus the safeguards to tell all of those who are suffering that they should have to wait, and we can revisit it some other time, I think is very unfortunate.

CASS:
Senator, I'm glad for the opportunity to respond, if I might. Look, I don't think I take second place in the concern for the needs of suffering humanity. Trained as a physician—for personal reasons, I won't recite the details, but most of these dread diseases that are talked about have been in my family, are in my family. I don't (inaudible) them. But there are—first of all, one runs a terrible risk of cruelly exploiting the needs and wishes of patients with the promise that the cures are just around the corner. We don't know. I grant you, we don't know which line of research is going to produce which benefits for which diseases. And I think that a fair minded person will say, not just adult stem cells, but embryonic stem cells should be tried. I'm in favor of that. OK? But, but, we also set certain kinds of limits around things that if we release those limits, lives would be saved. We do not allow the buying and selling of organs for transplantation even though lives might be saved if we allowed that to open up.

Similarly, it seems to me—look, we have the example of other kinds of countries. They're going ahead with embryonic stem cell research. They're going ahead with adult stem cell research. But they for their own good reasons—and the European parliament by a huge margin called for a ban on all human cloning, cloning. The chances that you're going to get something out of cloned embryos for research as opposed to ordinary embryos for research that's going to help these people—show me the data first. It's going to be decades before you'll have any, if at all.

WYDEN:
One last question. I appreciate the chairman's indulgence. Again, with so much of this having paralleled the debates we had years ago, I'm curious about the differences you see between this and IVF, in vitro research in the '70s. And in the New England Journal of Medicine article back in the '70s, you talked at that time about how there is no ethical way to proceed with in vitro fertilization research. But to your credit, you did not call for a ban on all governmental research. You said let's have the profession do internal oversight and scrutiny, intra-professional scrutiny, as you called it. And of course, there have been enormous gains and, you know, several hundred thousand babies born in the United States. Parents who carry genetic diseases are better able to avoid passing it along to their children.

Given the fact that we were careful then not to ban that research at a time when you and other prominent leaders in the field, why wouldn't we say the same thing now with respect to therapeutic research that I and others want to do? What's different? I mean, we have almost exactly the same concerns. We're in agreement that there are certainly potentials for abuse. In terms of the most egregious cases, you know, human cloning, tremendous support, the Congress' unanimity and the like. What's different now that requires this outright ban that is different than what we faced in the '70s when, to your credit, you and other leaders recognizing there was potential (inaudible) make sure there was vigorous oversight but didn't ban it by government.

CASS:
I think the difference, Senator—there are a number of differences. I'm not sure I can collect them all here. And with permission, if when I formulate my (inaudible) more carefully, I will send them in.

WYDEN:
Of course.

WYDEN:
Well, thank you, Mr. Chairman. And I want you to know first, Ms. Gulden, I'm going to do everything I can as a United States senator and not foreclose scientific options for progress and opportunity for people like yourself.

WYDEN:
I think that's what your government, you know, owes you. And I appreciate the fact that you've come today. You've made it clear you're not a scientist. And we're going to have various kind of complicated questions. We've talked about some of them here today. But I think what would be especially sad is that if options were foreclosed here, for example, in this country, and then similar cures were available overseas, what we would have said to our citizens here is that we didn't make the effort. We didn't try. And I'm going to work with those who don't share my views to set in place the kind of rigorous safeguards. I think that's important. And you've made it clear you support it.

But we're going to do everything we can to find the cures because there are too many people in this country suffering and hurting, and we owe it to them. So, I thank you for coming. And I have just one question for you. What do you make of this change from so many of the influential sponsors that they're now going to remove the ban on the importation of SCNT-derived technologies? To me, that's a clear admission that there is tremendous scientific progress here. What do you think?

GULDEN:
I wasn't aware that that had been removed.

WYDEN:
Well, that's what being discussed. What's been widely reported in the news media is that at the request of the Senate majority leader that would be removed by the sponsors. And perhaps you can get back to us when you've had a chance to reflect on it. But I think it's a major, very significant development. I think it undermines one of the basic propositions that supporters of the outright ban have been making. They've been saying it doesn't have great scientific promise. There aren't great opportunities for breakthroughs. And yet, they're willing to say that they'll their position on importation.
So we'll look forward—we'll get your response in writing. And mostly, thanks for coming. You're a powerful voice for making sure we're not foreclosing scientific options. And by God, we sure need that right now. And I thank you for it.
I have one question just for you, if I might, Dr. Usala, with respect to your research and certainly interesting and important. My question would be how effective would this kind of work be in conditions, various medical problems such as genetic disorders like Parkinson's or Alzheimer's? The reason I ask the question is it would seem to me that in one sense, you're in effect reintroducing the genetic disorder with regeneration. Is that an issue in your mind? And how would you react to that?

USALA:
There certainly would be some conditions, Senator, where you're absolutely right. Alzheimer's, Parkinson's aren't two of them. All diseases probably have some genetic basis for a (ph) predisposition. But, for instance, in diabetes, remember before 1992, everybody at the NIH believed that the complications associated with diabetes were genetic and that blood sugar control made no difference. And this was the cognoscente of the medical scientific community. And those that believed that blood sugar control did make a difference were viewed as extremists and not quite right.

Well 1992, after those extremists really pushed the issue, we found out that the extremists were right, and the NIH and the ADA, American Diabetes Association were wrong at the cost of hundreds of thousands of lives. My point here is that for things like Alzheimer's, there are still tissues—if we took that person's brain tissue and replicated it as it was during embryogenesis, you would still have another 60, 70 years of functional utility before the Alzheimer's again became a problem.

So I do agree that in certain very aggressively lethal genetic problems like Tay-Sach's disease, this would not be of any help. But neither would therapeutic cloning or embryonic stem cell implantation.

WYDEN:
Well Mr. Chairman, I think this has been an important hearing. As I said I guess two hours ago, you and I are going to agree on plenty of issues in the course of this subcommittee's work. And I think it's fair to say this is one where we do have differences. And we're going to talk about them in a reasonable fashion without the decibel level breaking the building. But I will tell you and those who are here, I just hope we can find a way to make sure that we send the message to all of those families and all of those Americans who are suffering today that we're going to stand by them. We're going to pick up on the excellent ideas of Dr. Cass who's here, Senator Brownback who is an authority on this subject to make sure that every reasonable precaution is in place.

But when we're dealing with heart disease and stroke and diabetes and Parkinson's and spinal cord injuries, let's do what those organizations the letters of which I've put into the record are urging. And that is they are saying let us pursue the route of careful science rather than putting up roadblocks of resistance.

And Sam, I thank you. I wish you well as you begin your service as chairman of the subcommittee. I wish I didn't have to give it up, but I'm looking forward to working with you.

BROWNBACK:
Thank you. And I want to thank the panel. And I also want to add my statements to what Senator Wyden was saying about our search and push for answers. I think we've got some great opportunities. And we're pushing them. I've supported strongly the doubling of the NIH budget because I thought we had some great opportunities. Still think we've got a number of them out there, very important to do. I do think as well you have to consider the dignity of each and every person. And we could learn a lot by researching, maybe even researching on me could learn something. I don't know. I may be too old and broken down at this point to do that. But there is a dignity to each and every person. And I hope we never forget that, whether we agree or disagree on topics that there's a great dignity to each and every person.

I do want to answer, Senator Wyden, your comment about the change of the bill, the bill on the international issue. And that was raised a number of times last year that people said, well, and if you find a cure overseas, and it comes here, you get penalized for that. It's not because of any findings that we're finding anything of success in the cloning field. Far be it, actually the research work is all what Dr. Weldon has said. We're not finding that. But to take away that area of argument because our desire is not to address things overseas, it's to address things in the United States.

And so we put that change in the bill to say we're addressing what's going on in the United States, not what's going on in other places. That's where our legislation should focus. We hope, and there is an ongoing international negotiations at the U.N. A number of countries, as Dr. Cass had pointed out, have already banned totally all forms of human cloning because they see the route of where this is going to. (inaudible) raise that and to deal with that argument that some had raised. It wasn't an admission that there's promise here because we still have not seen that in animal models and certainly not in humans.

Thank you all. Excellent hearing. Excellent panel. And we'll have further discussions on the topic.
Hearing's adjourned.