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The Nexus of Science and Foreign Policy: U.S. Biotechnology and Global Competitiveness [Rush Transcript; Federal News Service, Inc.]

Speakers: James C. Greenwood, President and chief executive officer, Biotechnology Industry Organization; former representative (R-PA), and Irving L. Weissman, Director, Stanford Institute for Stem Cell Biology and Regenerative Medicine; director, Comprehensive Cancer Center; professor, pathology and developmental biology, Stanford University School of Medicine
Presider: Justin Gillis, Biotechnology industry reporter, Washington Post
November 17, 2005
Council on Foreign Relations Washington, DC

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Council on Foreign Relations
Washington, DC

 

JUSTIN GILLIS:  (In progress) -- '82.  That is the first product of the biotech revolution.  In the old days, we had to get insulin by grinding up -- well, you don't want to know, actually -- (soft laughter) -- but now what we do is, we take the gene from a human being, put it into a bacterium, E. coli, and it happily turns into a copying machine and makes endless quantities of human insulin, which Eli Lilly sells at a high price.  And it's an improvement in medical care. 

That was the beginning of something that's turned into quite a much larger enterprise, and that's what we're going to talk about today.  We're going to talk about biotechnology, which is both a science and an industry.  Many people perceive it to play an increasingly important role in our country's economy and economic future. 

And I'm pleased to be joined on the stage today to talk about this by two of the most distinguished voices in American life on this subject.  On my left -- many of you actually know Jim Greenwood -- I'm sorry on my right, your left.  Jim was a member of Congress from, I think, the 8th District of Pennsylvania -- am I right? -- Bucks County --

JAMES GREENWOOD:  Right.  Right.

GILLIS:  -- for some years. 

GREENWOOD:  Twelve.

GILLIS:  He started his career as a social worker, actually.  He became expert in Congress on the subject of health care, wrote much of our modern legislation regulating the FDA and how they operate.  He now -- he's left Congress -- imagine that! -- and he is now the head of the Biotechnology Industry Organization, which is the very large trade group here in Washington of the biotech industry.  So his members and constituents are the very companies that we -- and scientists -- that we're going to talk about.

On my left, your right is Dr. Irving Weissman.  He is at Stanford University.  He's a professor there running an institute that specializes in stem cell research.  He's a member of the National Academy of Sciences, really one of the most distinguished scientists in our country on this whole subject of stem cell biology. 

He was the first person in the world to isolate any stem cell in any species -- that would have been the hemapoietic stem cell, the blood-forming stem cell in -- first in mouse and then immediately in human.  And that only happened, I guess, 15 years ago or so, but we're hoping that that's going to play a major role in cancer treatment in the future.

So, gentlemen, welcome. 

A few ground rules: we're going to go for about 25 minutes.  We'd ask everyone if you would please turn your cell phone off or put it on vibrate, so we're not disturbed.  Out of respect for our speakers, I think the ground rule here at CFR is please don't leave the meeting, barring disastrous emergency, until the end.  And we will go for about 25 minutes and then take questions from the audience.

So I want to begin -- we're going to talk about the role of this industry in the economy and really in our relations with other countries and in our international trade.  But let's begin with some ground work.  Jim, could you just give us a sense of the size and scale of it, sort of what's out there?  How big is it?  How fast is it growing?  And are you guys making money yet?

GREENWOOD:  Well, first of all, thank you for the introduction.  And yes, I did begin my career in social work.  And as I often say, working with acting adolescents was an excellent preparation for a career in politics.  (Soft laughter.) 

How big is it?  If you measure biotechnology by annual revenues, we're about $55 billion, which is a lot of money.  It's almost one-sixth of Wal-Mart's revenues.  If you measure it by companies, about 1,500 companies in the U.S., about 4,000 worldwide; measured by employees, about 190,000 employees in the United States, but those employees make about 75 percent more than average wages in the United States. 

We are not, as an industry, profitable yet, although there are the giants, like Genentech, Amgen, Genzyme, that make lots and lots of money.  Most of our companies are middle-size or rather small, and are still -- revenues come from investors, not from the sale of products.  Measured in potential, I think, the most transformational human endeavor ever.

GILLIS:  Wow.  What makes you say that?

GREENWOOD:  Because at its essence biotechnology is the study of life processes and their application to solving human problems.  We are at an inflection point, I think, where our knowledge about the 4 billion years of evolution that has led to life on this planet now is being understood at an increasingly rapid rate, and scientists and researchers are increasingly able to use that information to dramatically change human health, to dramatically change the food that we eat and in fact to dramatically change the way we make things in the world.

GILLIS:  But let me play devil's advocate.  So I heard you say $55 billion.  That puts you at about one-sixth the size of Wal-Mart.  I think I figured out the other day that if the whole industry were one company, it would only be about number 25 or 24 on the list of the Fortune 500.  So given that -- now we'll grant that it's growing rapidly, and certainly we'll grant that the ability to control life itself is probably going to be an important technology in the future.  Why are we so excited about it?  What really, in the real world, is this going to do for us medically and scientifically?

IRVING WEISSMAN:  Well, the important thing, if you're an M.D. like me, is it's saving lives that would have been lost.  And it saves lives first in the U.S., probably in California and the state of Washington and then passed on, because this is an important technology.  There's not an area of biology or life sciences, research and academic institutions or in pharmaceutical companies that doesn't use this as its platform technology.  So that's the first. 

It happened here, rather than elsewhere, because we didn't ban it.  We avoided bans.  Russia banned Darwinian genetics for about 50, 60 years, and they missed it completely.  So I think the important thing for us to know is that you can try to decide by ideology whether it's wrong to put a gene in a bacteria or a transponded stem cell, but nature is just going to come out with the truth, no matter what you think.

GILLIS:  Give us a couple of quick examples of areas where right now the technology is saving lives, if you would.

WEISSMAN:  Well, it's obvious.  I was an adviser to Amgen in the beginning, so you might take this as bias.  I still have stock.  But Amgen came up with erythropoietin, which is a red cell stimulator.  They did that -- the discovery was around, what, '83, '84, '85 -- took about 10 years to get it out to people through the FDA process.  If you have lost your kidneys and you're on dialysis, the only thing that keeps you alive, besides dialysis, is this drug, erythropoietin, because the kidneys usually stimulate the bone marrow to make red blood cells.  You get terribly anemic, and you need blood cell transfusions until you make antibodies against everybody as a donor, and then you would have died.

GILLIS:  And they became, I believe, the biggest biotech company in the world really on the basis of that drug, or on the basis of a couple of drugs.  Is that right?

WEISSMAN:  Couple of drugs.

GILLIS:  Yeah.  Right.

WEISSMAN:  That one, and another one, called GCSF, that helps wake up infection-fighting cells in the blood and get many more of them.  And that drug empirically, by accident, was found also to make stem cells -- the kind of stuff I work with -- divide in the bone marrow, to increase their number.  They go out into the bloodstream.  So if anybody ever was a donor or got a bone marrow transplant, instead of having about 70 to 100 sticks in your hip bone in a surgery suite, you just have to have a needle in the vein for four hours.  That was an unexpected consequence, but it changed people's lives also.

GILLIS:  So, Jim, this technology was created in the United States, really around San Francisco Bay.  Those universities were the pioneers --

GREENWOOD:  And Boston.

GILLIS:  And Boston.  And Boston, maybe.

We have actually been doing this -- now, many people don't know it, but we've been sticking, you know -- we've been moving genes between organisms, between different classes of organisms for 33 years, I think, with no mishaps, some controversy, but no real mishaps that one can point to. 

How are we positioned -- so here's a born-and-bred in the United States industry.  You know, there seem to be fewer and fewer of those.  We certainly can't make pants and shirts competitively anymore.  We are perceived to be in the lead on this.  We have the dominant position in the world.  How's the competition shaping up?  Where do we stand vis-a-vis the rest of the world now?

GREENWOOD:  Well, we're predominant now.  Probably 75 to 80 percent of the biotechnology work that's going on is happening here for a number of reasons.  Number one, it is an industry that comes straight out of academia, which is funded heavily by NIH, so we do that well.  And we have robust capital markets in which people -- we have a system where people take risks and invest in these companies.  So the good news is right now we predominate in a variety of ways.

What's the competition?  Our competition is strenuous.  The Chinese are hell-bent to leather to be a dominant player in this field.  So are the Indians.  Singapore -- the Europeans are engaged, but the Europeans are actually losing ground, primarily because of their price controls in their health care system, that they don't reimburse sufficiently to cover innovative costs.  And so much of the biotechnology in Europe has migrated to the U.S.

We are in danger of losing the Ph.D. battle, if you will.  Seventeen percent of American undergraduates are studying science, as opposed to something like 75 percent in places like China.  China will surpass us in a few years in the number of Ph.D.s.  And of course, right now, because of the limitations on our ability to do stem-cell research, there is a growing sense that there's an opportunity in places like Korea and Taiwan and elsewhere to get the jump on us.

GILLIS:  Are the Chinese and the Indians stealing the technology, or are they inventing their own?

GREENWOOD:  A little bit of each.  Notoriously, the Chinese have been disrespectful of intellectual property.  They are moving gradually in the right direction.  The Indians have dramatically or at least significantly changed their laws recently, but typically the Chinese and the Indians begin by reverse-engineering the things that we do through violation of intellectual property rights until they develop the expertise, and then they're off and running.

GILLIS:  Irv, where are your most brilliant graduate students coming from these days?

WEISSMAN:  Well, it used to be the United States quite a while ago.  It's not the United States anymore.   There are still, of course, several good ones that come through, but they're coming from China, from Japan.  For different reasons, those countries -- from actually Canada.  I must say I have good luck with Canadians, and that's unexpected.  Not that Canadians aren't the brightest, but it's just -- (laughter) -- the real push --

GREENWOOD:  Headline in tomorrow's paper.

WEISSMAN:  -- for Ph.D.s -- I know.  Forget --

GREENWOOD:  There's only 20 million of them.

WEISSMAN:  But nobody's going to write a headline from this anyway.  (Laughter.)

But you know, China, beginning with the opening of relations with China, sent their best and brightest students to the U.S. even after they had MDs or some degree, and they got a second Ph.D. here.  And then they decided to stay because politically it wasn't the best place to go back to; academically, if you wanted to do research, it's hierarchical or was hierarchical, so the professor told the assistant professor what to do.  There was no innovation going on.

That's changed completely.  They know what they're doing now.  They're trying to get rid of the corruption that had been present in the academics affair also.  They're attracting back -- a lot of these Chinese scholars came to the United States and they make up the best and brightest of our faculty.  They're equal to the rest.  But now they're getting asked to come back to China.  And they say, well, I don't know if China's really going to do what they say it's going to do.  And they say, well, why don't you come have a lab there while you stay at Stanford or Yale or wherever?  And that's happening increasingly, which opens up a real question about intellectual property and how do you judge where the discovery was made if you have lab here and a lab there?

I'm not so concerned with it.  My university certainly will be, but I'm not personally concerned.  I'm just saying that if China has the will, we've trained their best and brightest to be our best and brightest.  And if they just change the life for those who go back, instantly they'll be equal with us.

GREENWOOD:  I think it needs to be said that as we've watched our industries change in this country, in very recent times we have said, don't worry, yes, the widget-making is going to go elsewhere, but we'll still control the high-tech, we'll still have the intellectual edge on everything, and that's -- our kids will be doing all the smart jobs.  Guess what?  Not only is it -- can you buy a first-rate Ph.D. in China for $25,000 a year -- so they have the ability to make things with their inexpensive labor, and now they're absolutely neck-and-neck with us on the intellectual front.

GILLIS:  And they're -- pardon me.

WEISSMAN:  Let me just add in.  A lot of the blame goes through our failure to educate our people.  So in the K through 12 education in science, most of our kids learn science from people who never took science.  That's a mistake.  But if we want to keep up, and that is to have the elite of our young people being the leaders in science, it's not as massive an enterprise as trying to change all of K through 12.  I found that the most important thing is to make available to high school and college students good laboratories so they can work there over the summer and then after school.  And those who want to will find those places, and those people who find those places make up the majority of the successful scientists, not the top grade-getters.

GREENWOOD:  You know, when I was a boy, when Sputnik went over, my dad woke us up at 3:00 in the morning and we all stood out on the front porch and we watched Sputnik, and the whole country did that.   And we all saw it, and we went "uh-oh," and we changed math and science teaching.  The problem is what's happening in places like Korea right now is subtle, and nobody's stepping out on their front porch to see it.

GILLIS:  Sounds like both of you are ready to take on the teachers union.  Haven't you been down that road -- (chuckles) -- already?  (Laughter.)

GILLIS:  Let's talk -- well, by the way, there is a -- on this subject of education, there's a new National Academy of Sciences report; if people haven't seen it, brand new.  We are indeed having another sort of Sputnik moment in this country in the sense of worrying about our math and science education.  And if folks have not seen that, you might want to look it up.  It is brand new, within the last month or so, and quite well done and quite interesting. 

I think a lot of people in the audience probably want to talk about stem cells, so let's go there.  Give us a very quick precis on what a stem cell is, and why some of them are fine and some of them are controversial.  What's this argument about?

WEISSMAN:  Sir, I'm going to give you a short course in stem cells.  What distinguishes a stem cell in your body from any other cell is when it divides it makes at least one more copy of itself.  In the blood-forming system, only the blood-forming stem cell -- one in 20,000 cells -- make more of themselves.  All the rest spend their time dividing to become blood cells.  Self-renewal, that property of making one more of yourself, is a highly regulated and dangerous property if it goes out of control.  But the adult stem cells in the blood, the bone marrow, regenerate your blood every day.  The ones in your brain, believe it or not, are still regenerating your brain every day.  Your lung, your liver -- every organ system that we know of has at its base stem cells.  So the whole new era of regenerative medicine will be when we finally isolate each of those and can give them back to you or give them from a sibling, in a safe way, to regenerate your blood-forming and immune system and these other systems.

The blood-forming system is a very important platform because many of the diseases we have are genetic diseases inherent to the blood-forming system.  You know about severe combined immunodeficiency -- the bubble boy -- or you know about the various sickle cell anemia in the black population, Mediterranean anemia.  But all autoimmune diseases also come from the blood-forming system, including Type 1 Diabetes, juvenile diabetes.  So if you can replace a defective system safely with one that's not defective, it's a platform now to allow the system to be regenerated.  So if you'd lost your eyelets, then you could go for eyelets.  If you'd lost the cells that line the nerve fibers -- multiple sclerosis -- you could go after brain stem cells to do it.  So adult stem cells can do that, but a blood-forming stem cell can only make blood.

Even though you'll hear people, even from Washington, even in Congress, even in the Senate, even leading people say, oh, we know that one kind of stem cell can turn into another, so you don't need to go anywhere else to get all-purpose cells, it's just wrong.  When I go to the hospital with a heart attack and I have heart muscle dying, don't give me bone marrow blood cells.  There's a whole industry out there based on no science that's trying to do this.  So I'm just warning you.

Now, there are other kind of stem cells.  Very early in life, after the egg is fertilized, after seven or eight cell divisions, before what's called the blastocyst -- about 100, 128 cells -- before it implants in the uterus, there are about 20 or 30 cells that have not yet gotten instructions which tissue to make.  And in mice first in '85, in humans first in '98, you could take those cells out and put them in a culture medium, and now expand them to large numbers.  And when you remove the factor that helps them self-renew -- that is, remain stem cells -- they start making every cell type of the body.  They do it randomly and chaotically.  They can't get together to make a person, but they'll make some hair cells, which interests me -- (laughter) -- they'll make some nerve cells, they'll make every cell type in the body.  And it's trying to capture that that's important, first to understand development. 

But if I go to an in vitro fertilization clinic, the only place you have those blastocysts, and get those cells, they represent the genetics of the people who go to in vitro fertilization clinics:  white, well-to-do and infertile.

But if you wanted to have something that represents everybody in this room, you'd want to have a broader category of people.

Luckily there was an invention made -- again, in the '90s -- that you can take the nucleus, say, of my skin cell, which has all of my genetic information from birth, put it into an egg which had its own genetic information removed, and there's a way to stimulate them to go those seven or eight cell divisions appropriately and now make a stem cell line that has my genetics.  So if I had type 1 diabetes, I'd now have a cell line with type 1 diabetes that I could send to everybody but NIH investigators, because it's not funded by NIH, so they could study it -- or Lou Gehrig's disease, and on and on. 

And of course, if it came from me, and we could get the lung stem cells or the liver stem cells out of that, it would be more easily transplantable back to me.

So I said NIH ban -- so I'll just say it for a second -- August 9th, 2001, while, as Richard knows, I was head of a panel to study this at the National Academies, President Bush remarkably said, "You can work on those cell lines" -- embryonic stem cell lines, not the nuclear transfer that I was talking about, but the in vitro fertilization clinic-derived cell lines -- "but you've got to use ones that were made before August 9th."  And I thought it was great then, because that was a movement forward.  And he brought along people I'd never thought --

GILLIS:  He took office saying he was absolutely not going to allow this, I mean.

WEISSMAN:  Right.

GILLIS:  Right.

WEISSMAN:  Well, I don't know all the politics, but I know I was shocked.

But when we thought about it and discussed it in our panel, we realized that it was far from being enough.  And it certainly is far from being enough.  It represents the genetics of that population.  Those cell lines, unfortunately, were grown on mouse cells that carry leukemia viruses, the very same leukemia viruses that we have stopped gene therapy or trying to regulate gene therapy -- because they tend to insert in the chromosome, when they bring a gene in, and activate genes that could cause leukemia or cancer.

So those cell lines are insufficient.  We could not go forward in producing those cell lines with any government funding.  And everybody who's in the science industry knows that the National Institutes of Health has developed the greatest biomedical research institution in the world.  And we do have the best and brightest working at it, but they can't work on these things.  They can't work in a facility where any part of the funding came from the NIH, and that's why that's such a difficult issue.

I should say one more thing, because I forgot to say it, about adult stem cells.  We now know that every cancer is derived from the cells that were first self-renewing -- that is, stem cells -- and then as they passed on, they gain more properties, and now within every cancer and leukemia that we've looked at so far, it's a tiny subset, 3 percent of the cells, that are the cancer stem cells.  And all the rest -- they're daughter cells, failed growth -- are not important in the cancer, just that rare subset.

So stem cell biology, stem cell medicine, stem cell thinking is changing the field just as recombinant DNA changed it back in the 1970s.

GILLIS:  So --

GREENWOOD:  And it should be said that NIH funding isn't important just because it's more funding.  It's important because it funds things that the private sector won't risk.  So venture capitalists, the investors, they're looking for someone who's so far down the line that this dollar will eventually make them a profit.  The NIH funds much more abstract and pure research, which is absolutely critical underpinning of all those things that eventually become commerciable and usable.

WEISSMAN:  Yeah.

GILLIS:  So if you succeed, you're going to put Eli Lilly out of business on this product.

WEISSMAN:  No --

GILLIS:  You're going to cure the diabetics, you think --

WEISSMAN:  Oh, Eli Lilly has a lot more products than Humulin.

GILLIS:  They can sell hair transplants, right, or -- (chuckles) --

WEISSMAN:  They can do a lot.  You know, self-renewal for the pharmaceutical industry is that I remember to go take my pill every day.  Self-renewal with stem cells is a one-time treatment.  You're right.  That's nascent.  It's going to be terrific.

But of the various kinds of stem cells I talked about -- normal tissue stem cells, cancer stem cells, embryonic stem cells, nuclear transfer stem cells -- they each take care of different things.  And biotechnology protein companies take care of other things, and the pharmaceutical industry takes care of other things. 

I don't worry about the competition.  I don't think that people at Pfizer and Eli Lilly are sitting there at night worrying about stem cells changing their business.  I think the more important thing is, America becomes the leader in this field.  The scientific leadership was here, but the practical leadership is moving fast overseas.  Who's going to make it?  Who's going to do the clinical trials?  Who's going to get the first benefits?  That's really important.

GREENWOOD:  And in fact Pfizer and Lilly are busy gobbling up biotech companies and collaborating with them to fill their pipelines.

GILLIS:  Jim, let me get one more question in, and then we'll bring our audience into the discussion.  So if you could all out there sharpen your pencils or your questions -- and what we'll do in a few minutes is pass a mike around, so everyone can -- who wants to can get a question in.

Where are we in this country in deciding what our policy is going to be?  Now we're going to sort of -- I mean, there's no one here to speak for the social right, unfortunately, and I have to say I'm not particularly qualified to do it, either. 

So -- but let's just stipulate that there is certainly a controversy -- you know, this is an extension of the abortion debate. There is certainly a controversy, because in the procedure that Irv described, when you make an embryonic stem cell, at a -- there's a brief window when it is theoretically possible to implant that clone -- you didn't use the word "cloning," but of course therapeutic cloning is what it is.  When you implant that clone, if you were to implant that clone in a uterus, you could, in theory, make a baby.  And so people -- there are people who object to killing that microscopic organism and extracting its stem cells.

Where are we in deciding what our policy's going to be?  And where does our policy situation leave us in relation to other countries?  What are they doing?

GREENWOOD:  Well, you are right to indicate that this is -- this issue is welded to the hip of the abortion issue.  The problem is that those who are most ardently anti-abortion have to hold as a tenet of faith that once an egg is fertilized, it has the same moral -- it is morally equivalent to you and to me, and therefore it can no sooner be destroyed -- they have to hold that position, or they're on a slippery slope with regard to time, gestation.

So if they acknowledge that it's all right to take an embryo in excess, one of the 400,000 excess embryos created in in vitro fertilization clinics, and instead of saying freeze it for eternity, to actually utilize it to produce a product that will save the life of a child who was born through the in vitro fertilization clinic, then they have -- they feel that they are on a slippery slope and lose ground.  So they fight this issue as an article of politics and faith. 

Where are we?  Interestingly enough, there are -- there is a cohort of members of the Congress who are now saying, "I am a hundred percent pro-life, I've never voted pro-choice on the abortion issue, but this is too important for me to stay dogmatically there."

So for instance, Duke Cunningham in the United States House of Representatives switched and voted for the Castle bill, which would override the Bush limitations on stem cell research and allow NIH funding on additional lines of stem cells. 

In the Senate, most notably Orrin Hatch, but most recently Senator Frist has come over.

And so we passed the Castle-DeGette bill in the House this year.  There will probably be a vote next year in the Senate.  With Senator Frist's help, it will probably pass.  I suspect that the president will veto it, and I also suspect that this will become a significant issue in presidential politics in 2008. 

Where are we vis-a-vis the rest of the world?  The countries that I mentioned earlier -- China, India, Taiwan, Korea, most of Europe -- are not laboring under this limitation.  And although there actually have been some efforts, through the United Nations, to put some limitations on the use of embryonic stem cells, we are certainly, among the industrialized nations and the -- going in the wrong direction in this regard right now.

GILLIS:  And I'm right in thinking, am I not, that many countries have resolved their political debate, passed legislation, made a clear distinction between therapeutic cloning and reproductive cloning -- they've banned the latter, permitted the former, under careful ethical guidelines -- and so we have other countries moving forward.  Britain, I think, is a prime example of a country moving forward with this research.

GREENWOOD:  That's right.  And it's the checkered pattern in the United States.  Some states have passed, as California, affirmative funding for stem cell research.  Other, redder states, if you will, have blocked it.  And the -- there is almost a universal objection to reproductive cloning.  I share that view.  I think existentially no one should be -- come into existence because Professor So-and-So wanted to duplicate himself.  (Laughter.)  Everyone should have a mother and --

WEISSMAN:  We always get it.  (Laughter.)

GREENWOOD:  Yeah.  Right.  (Chuckles.)

Everyone should have a mother and father.  But therapeutic cloning is an incredibly important tool to science and to our future, and we have to get out of the Dark Ages with it.

GILLIS:  So surely by now someone in our audience is dying to ask a question.  Please go ahead.  And let's -- can we get a microphone, so the gentleman right here in the blue -- state your name, if you would, and remember that this whole discussion today is on the record.  So you will be sort of recorded, and -- (chuckles).

QUESTIONER:  David Apgar, Corporate Executive Board.  A quick question for Mr. Greenwood.  What is -- what are the prospects for turning therapeutic cloning into a states' rights issue and saying, "Look, the federal government should just pull out and let states do what they want"?  Because we know what Massachusetts and California would do and guess what Kansas would do, and maybe that would sort it all out.

GREENWOOD:  Well, actually, no, because the states' rights position already exists.  Thus California could appropriate or sell bonds to the tune of $3 billion and do all the stem cell -- embryonic stem cell research they want with their own dollars.  That's not -- and so it already is being played out, state by state. 

The problem is with the NIH dollars.  And the other problem is that I don't think you advance this science coherently with this state doing and this state doing that.  I think we need one central federal NIH policy to coordinate the research, so it's not duplicative.

GILLIS:  California's $3 billion is sort of a rounding error in the NIH budget, is it not?

GREENWOOD:  Well, $3 billion is money.  (Laughter.)  And no, it's pretty significant dollars.  It's over 10 years, I believe.

WEISSMAN:  Yeah.  Yeah.

GILLIS:  Please, in the back, the gentleman in the green.

QUESTIONER:  Thanks.  Hi.  Ralph Brave.  I'm a freelance science writer actually based in Davis, California.  And Dr. Weissman, it's an honor to be here with you today. 

I wanted to ask you kind of a difficult question, I guess.  Under Proposition 71, somatic subnuclear transfer is now a constitutional right; it's embedded in the Constitution in California.  And my understanding that the California Institute for Regenerative Medicine, which governs this 3 billion (dollars), if the court ever clears it to be issued, is currently -- has a standards working group to figure out how to manage a variety of the scientific researchers, including cloning, somatic cell nuclear transfer.

Do you have a model in mind for how cloning should be regulated in laboratories throughout California?  Should there be a central laboratory doing the somatic subnuclear transfer and then distributing the cells?  Or should each Stanford and UC and Children's Hospital be allowed to have their own cloning facilities?  What's the best regulatory mechanism, you know, in your mind?

WEISSMAN:  Sure.  Well, luckily the National Academies gave us an opinion in April about how to regulate this kind of research. 

The nuclear transfer -- somatic cell nuclear transfer started off as a very weak thing.  That is, it was very hard to get anything to work.  And because there was competition -- that is, a lot of scientists working first in mice and then in humans -- it got better and better.  But it isn't anywhere near perfect.

So you can say therapeutic cloning is ready for prime time, but it isn't quite.  And it'll get better and better.  And the better it gets, the fewer eggs that will be used.  And the fewer eggs that will be used, the further away you get from a real ethical problem:  How do you get eggs for this research? 

Now a lot of us believe you can make eggs from current embryonic stem cell lines or take them from ovaries of women who had it out for other surgical reasons.  That's very good and probably will answer the question.

But what I'm trying to say to you is, you're going to want the best and brightest at Stanford and those other, lesser California universities -- (laughter) -- to work as hard as they can in competition to find better and better ways to do this.

Now, how should it be regulated?  Every school that has it has to have at least two levels of oversight.  And we do at Stanford.  We have an institution review board that looks at any use of any human tissue for any reason.  And that's complicated and deep, and you know, people can talk about it.  But there are real questions of how you keep information private, how you get the stuff ethically, how you don't put anybody at any undue medical risk, and how you have informed consent.

Then above that there is an escrow -- these are research groups that oversee, independent of the patient-specific group, how are we doing this and how will it get better.

Then at the California level, the CIRM, the California Institute of Regenerative Medicine, has a regulatory body, which has medical ethicists, lay people, bioethicists, which are separate from medical ethicists, lawyers and so on, all looking in on the issue.  And every grant that goes in has to pass muster.  So that's even more than recombinant DNA. 

But regulating, rather than banning it, is the way that you allow things to go forward safely.  We have a perfect model with recombinant DNA.  Today even, 30 years after recombinant DNA got approved, I want to do an experiment in my lab that's novel, by putting one gene into a bacteria, I have to get approval at Stanford level.  If they kick it up, say it's new, it goes right to the RAC (sp) commission of the National Institutes of Health.  And if you're in a company, it goes to the FDA.  It's seamless, as far as I can see.

GREENWOOD:  Can I just say something about the politics of therapeutic cloning, because I -- twice when the House of Representatives tried to ban -- in fact did ban both reproductive and therapeutic cloning, I took to the floor the substitute that would ban reproductive but allow therapeutic. 

In nature, the vast majority of fertilized eggs never take root in a uterus.  They're flushed away, and they're destroyed.  That's the way nature does it.  So that's here.

In infertile -- in in vitro fertilization clinics, hundreds of thousands of eggs are produced, embryos are produced and destroyed, and no one is trying to ban that.  They wouldn't dare, because too many families -- talk about being pro-family -- too many families all over the world have joy because of these children in their lives.  And so that's here.

And then down here are the number of embryos that might be created through therapeutic cloning, and this is what we're fighting about.

WEISSMAN:  Could I just add one point to that before we get off it?  So when I was head of this panel at the National Academies, we looked at the issue of reproductive cloning, like Dolly, versus the nuclear transfer to make stem cells.  And we saw that in 2001, 99.2 percent of those embryos or blastocysts made by nuclear transfer, when implanted in sheep, mice, dogs and every species, 99.2 percent of them died in the uterus.  And those that lasted mid- to late gestation often took the mother with them.

So we were unequivocal that reproductive cloning was not ready, even if you thought philosophically it was the right way to have children; it was dangerous to the mother; there was no way medically, ethically, under the Nuremberg guidelines, that you could do this.

So we called then, in 2002, for a legally enforceable ban on reproductive cloning, and Jim was one of the few who separated that from the promise of nuclear transfer. 

And I'll just say one more thing.  I'm an M.D.  The one oath that all M.D.s take is that the patient's health -- current and future patient's health is your first responsibility, your first priority.  So whenever the issue comes up of making a cell line from this questionable entity that has no chance of making a baby honestly, versus the people who are dying of diseases now, who have a short window of time when they could be cured, I know which side of the issue I have to be down on, and I believe it's the same issue that most of you have to be on. 

That is, we're on a clock here.  Every time we wait, somebody's losing their chance of staying alive.  And these aren't rare diseases.  These are the common diseases in a place that has good sanitation and good public health.  These are -- maybe half the people who come to Stanford Hospital have genetically determined diseases that we don't yet understand but probably could understand if we could do this kind of research.

GREENWOOD:  And for those who call embryonic stem cells morally equivalent to the rest of us, I always say if there was a building in which you had some frozen embryos, and over here you had a nursery full of children, and the building caught on fire, would it be a tough decision as to which way to go to rescue people?

GILLIS:  I wonder if we've laid -- if we haven't missed a little bit of the -- maybe the audience would want to understand a bit more about the rationale for what you're talking about and what we want to do. 

So just to illustrate by example, you can -- people have figured out how to cure diabetes.  It's called the Edmonton Protocol.  You can transfer islets into type 1 diabetics, suppress their immune systems with arduous organ transplantation drugs and cure diabetes.  It's so arduous, and it puts you at such risk for other infections and so forth, and we don't have enough islets -- they're islets from organ donors, essentially -- that it's never going to be sort of a widespread procedure.  So the idea here is if we do what Irv's talking about and we make a, quote, "clone" -- that word clearly has become problematic -- but if we make a microscopic clone, derive stem cells, turn those into pancreatic islets, we would be able to give you back islets, or conceivably livers or kidneys, that are genetically identical to you.  There would be no rejection problem.  And so that's the --

QUESTIONER:  (Ralph Brave) Excuse me, excuse me.  Diabetes is -- type 1 is an autoimmune disease.

GILLIS:  Oh, no, I understand, I understand.

QUESTIONER:  (Ralph Brave) So there is a rejection problem --

GILLIS:  I understand that.  Part of the premise that --

QUESTIONER:  (Ralph Brave) That's not what you said --

GILLIS:  Right.  But part of the premise would be that you would correct the autoimmune deficiency in some way --

QUESTIONER:  (Ralph Brave) No, you -- not with --

GILLIS:  Well, we're not -- let's not have an argument about it, I mean.

WEISSMAN:  No, let me just -- I'll just give --

GILLIS:  Sure. 

WEISSMAN:  You can --

QUESTIONER:  (Ralph Brave) I'm not trying to argue, but I'm stating the facts --

WEISSMAN:  No, no.  You can give immunosuppression, and it is about as dangerous as giving insulin for life.  But now we've shown in many animal models that if you take blood-forming stem cells and islets from the same donor or the same cell line, the blood-forming stem cells correct the autoimmunity, absolutely, in every animal model, and the islets are accepted without any immunosuppression, other than the first to put in the blood-forming stem cells. 

So it is true that five, 10, 15 years down the line, if we could move as fast as possible with this nuclear transfer research or embryonic stem cell research to get transpondable cells that don't contain leukemia viruses, we'll move very fast on that disease and multiple sclerosis. 

There's another example that's really important to know.  Lou Gehrig's Disease is just one of the examples where the Genome Project, a fantastic thing that's going on, gives us hints about which genes are involved, but doesn't tell us, of course, which ones cause the disease.  And we're not going to go into patients and try to figure out which gene is causing the disease that inevitably kills somebody by loss of their motor neurons in a horrible way. 

But we could make cell lines from their skin nuclei.  And there's a good bet -- in fact, there's good precedent in animal models -- that those cell lines could make the motor neurons, which could be tested in the spinal cord and brain of a mouse, and the muscle cells to which they must attach, and then ask, by fixing one gene at a time, which one was important for this disease.  And the pharmaceutical industry, which is a small molecule, could now know which of the genes and which gene products are the targets.  So I hope that the pharmaceutical industry jumps on the bandwagon pretty soon, even if they're not going to the people -- be the people who do this cell therapy or cell examination.

GILLIS:  The gentleman's point is certainly correct that this is not proven science by any means yet.  We are a long way from being able to claim that this is absolutely going to happen.  It's a scientific hypothesis.  And many people see it as the likely way to -- or the likeliest way to solve some of these problems.

Now, the Koreans, though, are ahead of us in doing this, aren't they?  What's the situation?

WEISSMAN:  They're ahead, apparently.  In -- during nuclear transfer, they've improved the technology -- it's not really pure science; it was empirical technology -- to improve the frequency in which a nucleus put into a human egg could give rise to a cell line. 

Now there's been one -- a fallout between of the members of the group.  You could read about it in The Washington Post.  And I would just advise everybody to wait a while before you make any decisions about whether the questions about the ethics raised by this person has anything to do with the science.  I'd like to say that nothing in -- certainly in the life sciences is proven until not only is it published in a peer-reviewed journal, but several good independent labs can repeat it; third, that the principle is so strong that any way you look at that principle, you can do it; and of course, in transplantation, that the cell type you get out is so robust it will regenerate your tissues in the time needed.

GILLIS:  But there is at least this fear that the -- particularly the Asian countries, which have no cultural objection to the procedures that we're talking about, are possibly going to gain a jump on us in learning how to do --

WEISSMAN:  If you include in "other countries" California, I agree with you.  (Laughter.)

GILLIS:  Yes, the gentleman right -- in the blue blazer here.

QUESTIONER:  I'm Bruce MacDonald of the Provectus Technologies.  I was in Ireland last month, and I -- (audio break from source) -- Examiner, the newspaper, and noticed an ad for -- they were hiring people because they said there was a stem cell research laboratory that was moving lock, stock and barrel -- had just moved, left the United States and gone over to Ireland, a highly Catholic country, of course, but they appear to be moving forward. 

And I was wondering, first of all, how much of a trend is that because of the restrictions on our funding, because I have to say I was just taken aback by the sort of the bluntness of that ad for hiring people. 

And then larger thinking, for biotechnology, you've got -- on the one side, you've got all the concerns about stem cells, and on the other side concerns on recumbent DNA, "frankenfoods," GMO.  And so it's kind of a double-barreled question.  One, what is the threat of -- the longer we have the restrictions on stem cells, that we'll see this outward migration of research teams and jobs and so forth?  And then, just secondly, how do we -- taking into account, you know, people's religious and moral beliefs, which we all have to respect, but how can we make progress to free up -- because I have to believe that these concerns, you know, are probably -- restrict the availability of research funds to be able to do the kinds of good research that universities and companies can do.  And I throw that out to both of our guests.

GREENWOOD:  Well, there's no question but that Ireland is very aggressive in trying to attract jobs in general from the U.S. and particularly in the life sciences. 

I don't think we're, frankly, at a point where anyone would make a rational decision to take a company -- and when you say a stem cell company, there aren't very many of them -- but over to Ireland.  You don't outmigrate from the United States because the NIH is not funding academic research.  You might migrate to a California in order to avail yourself of those funds.  But I don't think we're at the point, frankly, where rational decisions are being made to migrate out of the United States. 

I do think that -- I am optimistic that we will resolve this issue legally -- legislatively, I should say, in favor of allowing this research.  I think, actually, if I may be permitted, that the stem cell debate will change abortion politics more than the abortion debate.  And I say that because voters are prepared to say today, I'm pro-choice; he's pro-life.  I'll overlook that because Roe v. Wade is the law of the land and I'm not in the market for an abortion.  But now he's the same guy in the same Congress who is blocking stem cell research, and guess what, it isn't the law of the land that we have unlimited access to fund this research.  And I am in the market for saving my life and the life of my loved ones.  So now, you've got to go.  And so, actually, I think that's the way the political thing will work out.

In terms of the -- yes, I respect those who have a different ethical view of embryos than I.  I don't respect those who wish to put their religious ideology in federal statutes.

WEISSMAN:  So, if I could just add this small part. 

So there are certainly other countries -- Singapore, China, India -- that have put a lot of money into this research.  Singapore is very telling right now because the architect of this particular movement in Singapore in bio-medicine was one of the architects of Bangalore technology development.  So he knows how it works.

Their plan -- I've talked to them a lot -- is not only to do this research, but to recruit American scientists.  I just lost a recruiting battle for two of the great cancer gene people, who decided they had to leave the U.S. National Cancer Institute because of all these restrictions.  They were going to come to Stanford.  Because of Prop. 71 delay they had to make a decision, so they're going to Singapore. 

Singapore gets it.

Now, guess what else Singapore and India and China are building -- medical tourism.  So now they'll have not only the means of discovery, the means of clinical trial, the means of distribution of the health care.  That won't mean that the poorest in the United States are going to go there, but a lot of people from the States will go there.  And if Senator Brownback's bill criminalizing this research actually could pass -- and there were times when we all worried it could pass -- then the patient that would go over there or the doctor that recommended they would go over there to get the therapy derived from this research would be liable to a million-dollar fine and 10 years in jail.

GILLIS:  There's a gentleman --

GREENWOOD:  There's another component of this that is advantageous for the Indians and the Chinese, and that is, companies looking to do clinical trials on large populations are able to do their clinical trials in those countries, number one because they have huge supply of patients, number two because when you do a clinical trial, for ethical reasons, the experimental product has to be -- you can help me on this, Doctor -- but it has to be as good or better than what's available to the patient.  Otherwise, when you go to these developing countries, the state of the art of health care is so -- is relatively low, so therefore an experimental product might be the best chance that that patient has.

GILLIS:  There's a gentleman in the back -- right in the back there -- that's been trying to ask a question.

QUESTIONER:  Joe Onek, Open Society Institute.

Aren't there other important technologies that are threatened by the conception that an embryo is alive?  For example, we now have the capacity, and we do test eight cells for Tay Sachs disease, Huntington's disease, and shouldn't we be publicizing that because that's a whole other group of people who obviously will support the idea that under certain circumstances you have to sacrifice these rigid religious conceptions in order to protect health.

GREENWOOD:  Go ahead -- no, you go ahead.

WEISSMAN:  Well, I asked Karl Rove that question in a public setting.  I said, how could it be that you're so strongly against new embryonic stem cell lines from the in vitro fertilization clinics and so strongly against nuclear transfer that could not make a viable person, but you allow those 400,000 excess blastocysts to be created and destroyed.  And so what Karl Rove said -- you know, it was an open setting -- was, well, that we don't regulate in vitro fertilization clinics.  Now, that's, of course, an easy way out by saying that.  But if they had brought the same intensity of moral objection -- of course, if you believe that and you believe that you should impose that on everybody, then you should stop in vitro fertilization.

GREENWOOD:  And to answer also more broadly, I think the -- that these kinds of government-imposed limitations upon science have an effect that's broader than what we're -- much broader than what we're talking about here.  It's the ability of investigators to pursue the science and -- not knowing what the implications are.  And it has very broad implications for not only biotechnology but science in general.

GILLIS:  We are running low on time, so let's get a few more questions in.  There's a gentleman over here.

QUESTIONER:  (Off mike.)

GILLIS:  Could you grab the microphone there?

QUESTIONER:  Yeah. Don Bandler.

(Comes on mike.)  I wonder if you could just give us your brief assessment of the international regulatory landscape and whether, on balance, you think that that offers hope in terms of moving forward and perhaps escaping from some of the -- I don't want to use the word picayune, but -- because it's much more serious than that -- but some of the problems we're having here advancing as quickly as we would like, and, you know, and looking at it -- I look back at it in the perspective of the -- at biotech, where it took a long, long, you know, of U.S.-European debate and the world -- the WTO case to try to wrangle differences on regulation.  Do you anticipate that we might get there, or in this case, can it be an engine?

GREENWOOD:  Well, first off, the United Nations -- there was an effort in the United Nations to actually pass a restrictive protocol, and that was blocked, but it's still sort of percolating out there.  I think it's the United States and -- I forget which other country --

WEISSMAN:  Costa Rica.

GREENWOOD:  -- Costa Rica led that effort, and it was -- through procedural method it was postponed.  But on a country-by-country basis, I think to some extent this will -- this is and will continue to be fought out just like it is in the various states of the U.S.  There will be -- there are some countries that will take a dim view of it and have and will in the future specifically delimit it.  And while there are other countries who will specifically open it up, encourage it and fund it.

GILLIS:  The politics of this are odd.  The Lutheran Germans, I think, have more objections, for instance, to this technology than the Irish do.  It's -- I suppose the Irish are abandoning their Catholicism rather rapidly, but --

GREENWOOD:  Opposition to genetically modified foods tends to come from the left, and the opposition to this tends to come from the right.

GILLIS:  We should be clear, the Europeans make a, in their minds, a pretty bright-line distinction between what they call red biotech, which is the human health stuff, which they're all in favor of, and what they call green biotech, to which they -- any release into the environment, they are -- the public opinion there is skeptical of, right?

GREENWOOD:  An equally irrational argument.

GILLIS:  Let's get one or two more questions in before we have to quit.

The gentleman down here in the front -- can we get a microphone down pretty quickly?

I think, Don, you're a former ambassador to -- remind me.  Am I right?

QUESTIONER:  Cyprus.

GILLIS:  Were you not -- I'm sorry.

QUESTIONER:  Cyprus.

GILLIS:  Cyprus, yeah, right.

QUESTIONER:  Steve Charnovitz, GW Law School.

Congressman Greenwood, you called the U.S. regulatory environment the dark ages.  And like all dark ages, it will eventually end.  But there will always be regulatory issues that will be important -- funding and regulation.  I wonder if the panel could comment on efforts of the business community and the scientific community to help inform public opinion on this matter and to deal with some of these legitimate ethical and moral concerns -- try to raise the comfort level of the public about this important technology.

GREENWOOD:  That's a good point, and I'm the president and CEO of BIO, which is the advocacy organization for biotechnology, and that's a major function of my job.  We are very busy.  As a segue, when I announced that I was not going to run for re-election in the middle of last year, then I -- I finished out my term; I spent six months with my colleagues in this lame duck function.  My colleagues would see me on the floor, in the halls and the elevator and say, oh, Jim, you're leaving Congress.  And I'd say, yeah, I am.  Where are you going?  I'm going to BIO.  Well, what's that?  It's the trade association for biotechnology.  And then in unison they would all say, ah, stem cells.  And if they didn't like embryonic stem cell research, they would look at me and what you could see in their eyes was, figures that's where you'd go, Greenwood.  (Laughter.)  If they liked it, they'd say, go get those stem cells.  But it told me that that's about all my colleagues know about biotechnology.

And so we are doing a very comprehensive job with an 11-minute video, educating members of Congress what biotechnology really is.  And in the coming year, I'm going to spend a lot of my time at a higher level educating members of the public in general, and bio is going to do that.

There are so many misconceptions here.  If you got rid of the misconceptions -- many members of Congress and the public are still back on the fetal tissue debate.  They think this is all about encouraging abortions.  When you get past that and you get into cloning -- I remember having this debate on the floor, and Chris Smith said, you know, they're going to make embryo warehouses through cloning.  And I said -- I interrupted -- I said, well, I'd yield the gentlemen some time if he'd explain how that would happen.  (Laughter.)  And I think he actually literally had sort of this cartoon -- two, four, you know, eight, sixteen -- that some magic process just -- you know.

So there is -- the reason I'm optimistic is because the public knowledge is here, it can get to there, and when it does I think we'll have them.

GILLIS:  On cloning versus much of this other stuff, there's a pop culture reference clearly that people are reacting to.  You say clone and people see "Boys from Brazil" and all that.  Is anybody here an identical twin, by the way?  No one in the room.  If you know any identical twins, they're clones.  They're -- I mean natural clones, but -- I'm sorry.

WEISSMAN:  Let me just add a short point.

So -- I think what Jim was saying, I think anybody who wanted to get a good idea of the level of understanding in the Congress and the House of Representatives should go back to the Congressional Record July 2001, the debate you're talking about, because that wasn't even the worst.  (Laughter.)  You know, armies, that we mad scientists wanted to create mutant slave armies. (Laughter.)  You know, a total --

GREENWOOD:  We don't?  (Laughter.)

WEISSMAN:  -- complete lack of understanding at every step of the way.

But I think once you get beyond the literacy of Congress -- we went to the people in California -- it's a perfectly good experiment -- for Prop. 71 and explained it in fairly, I think, honest and straightforward terms what the limits and what the possibilities were, and it passed 59 to 41.  And lest anybody think that there's a hype out there that you could get a cure tomorrow or even five years from now if you passed this legislation at the federal level, just the limitations of FDA Review for phase three, four and then phase one, two trials, says five years at least.  And then pre-clinical studies, three or four years.  And then discovery, God knows how long.  So it's not tomorrow, but it's for our kids.  And we're going to limit the future of our kids if we allow this to keep going on as it is.

GILLIS:  I think on that note, we're going to have to close because we are out of time.  Thank you all for coming, and we'll all be around here for a few minutes if you want to -- (applause).

 

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