60 Minutes, Amended

I emailed my piece to 60 Minutes last night while being extremely annoyed at the horrible job they did at correctly articulating the therapy Geron hopes to begin trials on in early 2007. In so doing, I neglected to provide specific instances of why 60 Minutes' reference bothered me so.

To clarify, I thought that the story was, overall, a good one; I am always happy to see cure-focused research get positive exposure. Dr. Keirstead is a very charismatic speaker and a brilliant researcher. Suzanne Short gave a good performance, explaining that, for a high level quadriplegic, something as simple as the ability to transfer oneself to and from bed would dramatically improve her level of independence and quality of life.

But, there's that one part that grated on my nerves. And it happened early.

Pending FDA approval, correspondent Ed Bradley reports that would make him the first scientist in the United States to transplant embryonic stem cells into humans.

First, and I must make this clear: No sane scientist would ever transplant embryonic stem cells into a human being. They would form tumors.

Which brings me to my second point: Why do religious types who oppose embryonic stem cell research always tout the fact that embryonic stem cells will form tumors as some "dirty little secret" that ESC proponents avoid talking about?

I'm going to pick on Paul A. Long here, as he was the lucky author of a recent piece from the Detroit Free Press that Google News introduced me to.

More alarming is that embryonic stem cells are highly prone to uncontrollable growth and tumor formation when placed in animals.

I am going to be very mature in my response: Duh.

No offense to Mr. Long, of course. I'm sure he is a nice guy and all, and that we agree on a number of issues and such.

And since he's such a nice guy, I am going to let him in on a secret: Proponents of embryonic stem cell research do not discuss the risk of tumor formation because nobody is considering transplanting embryonic stem cells into people.

Why this myth continues to get perpetuated, I have no clue. Stories like those that appeared on 60 Minutes are probably one reason.

That, my friends, is why the story annoyed me so much. Their erroneous reporting that Geron will be transplanting embryonic stem cells into humans perpetuates this myth.

If Paul A. Long wants to discuss a realistic risk of tumors as a result of embryonic stem cell transplants, feel free to talk about the possibility that any cultured derivations of cells from embryonic stem cells that will be transplanted may not be 100% free of embryonic stem cells and that because of this potential error, there is a risk of tumor formation.

Or, since his concerns are centered on the moral impropriety of destroying embryos to obtain these stem cells, discuss the need to find alternative, embryo friendly methods of deriving embryonic stem cells.

Just, please, disagree with the research all you want. But do so in a fashion that moves the debate forward on all fronts. It will one day be possible to go to the doctor's office and have a skin biopsy sent off to a lab to generate a perfectly immune compatable set of embryonic stem cells -- all without creating or destroying an embryo.

I want that day to arrive, and sooner, rather than later.

Four Things

Rebecca Taylor from Mary Meets Dolly tagged me, so I get to fill this out. Here goes:

Four jobs I've had:

1) Bagboy at grocery store
2) Webmaster for a local coffee business
3) Freelance programming
4) Columnist

Four movies I watch over and over again:

1) Aladdin
2) A Few Good Men
3) Stigmata
4) Pleasantville (always on tv)

Four places I've lived:

1) Charleston
2) Uh, Charles Towne?
3) n/a
4) n/a

Four shows I watch:

1) House
2) Veronica Mars
3) American Idol
4) Naruto

Four places I've vacationed:

1) Hilton Head
2) Myrtle Beach
3) Orlando
4) Michigan

Four websites I like:

1) CareCure
2) Slate
3) Christian Science Monitor
4) A List Apart

Four of my favorite foods:

1) Baked chicken
2) Baked potato
3) Chicken teriyaki
4) Cheesesticks

Four places I'd like to be right now:

1) Washington, DC, lobbying Congress
2) San Francisco, CA, just for fun
3) Brisbane, Australia
4) On a date with Lisa Loeb

I don't chat with many bloggers, so I can't tag too many people. But I will tag my editor over at Bodyhack.

The Myth Lives On

Good news, this morning: Only one article has been written so far about last night's 60 Minutes episode with Dr. Hans Kierstead (per Google News).

Bad news, this morning:

Amazingly, after injecting the rat with human embryonic stem cells, the paralyzed rat was able to move its hind legs. Dr. Keirstead told Mr. Bradley that “If it does the same thing in humans, I think we’ve hit something here that’s gonna be truly remarkable."

*sigh*

60 Minues, Embryonic Stem Cells

I was rather disappointed by the errors with the report tonight by Ed Bradley during 60 Minutes.

Laboratory rats whose hind legs were completely paralyzed — until they were injected with human stem cells. Remarkably, afterwards, the rats were able to walk again.

They were treated with human oligodendroglial precursor cells -- not stem cells.

Pending FDA approval, correspondent Ed Bradley reports that would make him the first scientist in the United States to transplant embryonic stem cells into humans.

Wrong: oligodendroglial precursor cells.

There are similar errors through the story, and I don't feel like correcting them all.

Here is an email I sent to 60 Minutes:

Dear 60 Minutes,

I am a partially ventilator dependent C3 quadriplegic and columnist with Wired News. I was excited to hear about Sunday's show and the Hans Kierstead segment.

Then it aired, and I was severely disappointed by the flagrant inaccuracies it included. Hans Kierstead's team does *not* transplant embryonic stem cells into the spinal cord. They generate a specific type of cells known as oligodendroglial precursor cells (OPCs) by culturing the embryonic stem cells and then transplant these OPCs, which remyelinate the demyelinated axons.

As a fellow reporter, I am disappointed that you allowed the segment to air with such lax fact-checking.

I hope that you will take it upon yourself to issue an immediate correction, both on-air and online. Please, feel free to check with Dr. Kierstead and Dr. Okarma, CEO of Geron, before you do so.

As a spinal cord injured person and research advocate, I am appalled. Perpetuating such errors makes advocating for a cure much more difficult, which directly prolongs my paralysis induced suffering -- and the suffering of the more than 250,000 other spinal cord injured persons in this country.

With sadness and disappointment,

Steven Edwards
Wired News

Leonard Zon: SCNT Creates Embryos

Quick background on Leonard Zon:

Dr. Leonard Zon is the founder and director of the Stem Cell Program at Children's Hospital Boston and the first incumbent of the newly established Grousbeck Professor of Pediatrics Chair at Children's. An internationally renowned pediatrician and researcher specializing in blood diseases, Dr. Zon is also a Howard Hughes Medical Institute Investigator, founder and immediate past President of the International Society for Stem Cell Research (ISSCR), and Chair of the Harvard Stem Cell Institute's Executive Committee.

It should be fairly evident, based on the positions he holds, that Dr. Zon strongly supports human embryonic stem cell research.

He apeared in a recent Talk of the Nation episode along with three other medical professionals to discuss the embryonic stem cell ballot in Missouri, and research in general.

A segway occurred wherein the discussion turned to how the terminology we use to describe new technologies affects the public's perception and acceptance of said technologies. The example was given of "nuclear magnetic resonance imaging," and how the word nuclear scared people at first. The word was dropped, and today magnetic resonance imaging -- or MRI -- is a fairly routine procedure.

What if the debate could be reframed by removing any reference to the embryo? Dr. Zon responds (at 32:28, if you care to listen).

I'm a little bit concerned about the nomenclature which you bring out, and there was a movement among some researchers actually to call nuclear transfer-embryonic stem cells "pluripotent cells" for just this reason -- they wouldn't be embryonic. I really think that if we're going to be honest with the American public that you do create an embryo during this process.

Will the pro-ESC crazies (i.e., the fascist portion of the pro-ESC movement) now call for Dr. Zon's head?

Only time will tell.

Simply Atrocious

A writer for the Bryan-College Station Eagle penned what may be the most inaccurate piece on embryonic stem cell research I have ever read.

First, there is a lack of consistency in the terminology the author uses to describe the embryo.

Some religious groups believe that life begins when sperm and an egg collide; they condemn research that causes embryos to be destroyed.

Notice the inference: "when sperm and egg collide" equals an embryo.

To obtain stem cells, the fertilized egg is allowed to grow for a few days. Then the inner cell mass is removed and cultured into stem cells. These stem cells have the ability to develop into different types of cells that the body needs.

Fertilized egg? Not too bad. The reader can easily substitute embryo for fertilized egg.

Religious objections arise because the fertilized cell is considered to be alive; therefore, to destroy it is tantamount to murder or abortion.

Fertilized cell? Please tell me this author is just trying to catch their editor asleep at the keyboard?

Luckily, that's where the terminology issue ends. Unfortunately, factual errors continue.

To appease both sides, in 2004, President Bush declared that only 15 lines of stem cells would be eligible for federally funded research.

If you can't say anything nice, just provide corrections.

Bush's decision was made in August, 2001. He (arguably) believed he was authorizing funding for over 60 lines, but only 22 are currently available.

A recent development (SCNT) that does not use embryonic cells allows medical researchers to take cells from a patient's body to make stem cells.

SCNT, or somatic cell nuclear transfer, produces an embryo.

This process is called somatic cell nuclear transfer. To make the stem cells, the nucleus from the patient's somatic cell (skin, heart or muscle) is transferred to an empty, unfertilized egg cell that has its nucleus removed. The egg cell with the new nucleus then produces unspecialized stem cells in lab dishes that can be used in general way.

SCNT does indeed produce "unspecialized", or embryonic, stem cells, but not directly. SCNT produces a functionally competent zygote, which goes on to form a blastocyst in about 5 days.

At this point, the blastocyst makes up the entirety of the organism. The blastocyst has two main structures: 1) the inner cell mass, comprised of embryonic stem cells, and 2) the trophoblast, which is the "skin" or outer layer that contains the embryonic stem cells. To obtain the embryonic stem cells, scientists must destroy the blastocyst, what many believe to be life.

The site lists no email address to submit corrections, but feel free to email these guys with the above corrections.

Newsweek Clarification

Newsweek's Eleanor Clift has a new column out discussing Senator Talent's stem cell switch and whether it will affect his re-election chances in November. The story is standard fare, but the second paragraph is riddled with mistakes.

Let's begin.

Talent cited new science that would alter the genetic material of an embryo to prevent it from developing into a human being. A “developmentally disabled” embryo should in theory address the moral qualms of critics who view even an unfertilized egg in a petri dish as a potential person.

The second sentence is just... bad.

The author mistakenly equates two disparate issues: 1) objections against creating a “developmentally disabled” embryo (intentionally creating a crippled embryo); and 2) objections against germ-line modification. The first objection centers around scientists creating a human life, only to turn around a week later and destroy it for its "parts" (i.e., stem cells). The second with creating "designer babies".

(There's also a small issue about creating a life outside of the sanctity of marriage, but that's the weaker argument, so I will forego it.)

Then we have this ... inaccuracy.

But the reaction to Talent’s shift was blistering. Pro-life conservatives felt they’d been betrayed and threatened to abandon him at the polls, and the U.S. Conference of Catholic Bishops, which helped write the Senate bill, rejected Talent’s rationale that there is “an ethically untroubling way” of getting embryonic stem cells.

I believe the quote provided by the author misrepresents the position of the United States Conference of Catholic Bishops (USCCB).

Richard Doerflinger, Deputy Director of the Secretariat for Pro-Life Activities for the USCCB, has testified before the President's Council of Bioethics on the issue. Excerpts:

If, and this is a big if, a procedure can be found to provide embryonic stem cells without creating or destroying embryos, that would address the Catholic Church's most fundamental moral objection to embryonic stem cell research as now pursued. Clearly, such a procedure would not be prohibited by the cloning bans the Catholic bishops have supported at the state or federal level, which routinely exempt the use of nuclear transfer or any other cloning procedure to produce tissues, organs or cells other than human embryos.

I, therefore, see no moral reason at this time to oppose the further exploration of this theory in an animal model so its feasibility can better be assessed. This would give scientists an opportunity to show their real commitment is to scientific progress, not to the exploitation of embryos, and gives organizations like mine an opportunity to show that our concern is respect for life, not a fear of scientific research or scientific progress.

He continues on to discuss Altered Nuclear Transfer (ANT), explaining that the existing animal data is not sufficient to convince him that it does not create an embryo and, therefore, opposes its human application. Then he adds this:

Or perhaps other ways to achieve complete or partial reprogramming of a body cell nucleus without using an egg will be further refined and replace the use of eggs for this technique.

Fund it, and it will come.

Embryo, per Oxford

Oxford has a semi-decent grasp of the English language. In their ever precise British tone, they provide the following as a definition for embryo:

Embryo: 1 an unborn or unhatched offspring in the process of development, especially an unborn human in the first eight weeks from conception. Compare with FETUS. 2 the part of a seed which develops into a new plant.

It appears that everyone can find a dictionary that agrees with them.

Senator Talent, part deux

I found the text (.pdf) of Talent's comments.

The media failed to completely cover Talent's floor speech. One thing this has tought me: Never believe information to be accurate unless it provides a source.

Important excerpts:

The answer is for both sides to take advantage of scientific changes to find proposals which they can mutually support and which offer advantages to each compared to the current stalemate.

To that end, I propose a competition, to be managed by the National Institutes of Health, which would create incentives for our great research institutions to get the genetically matched stem cells we need without risking cloning an embryo. Simply put, the NIH would take applications from research institutions with research plans to accomplish the goal. The exact funding and practical details of this would have to be carefully worked out, but let me put forward a preliminary proposal. Five institutions would be selected for the competition and provided $10 million each to conduct their comprehensive plan. The first institution to successfully harvest genetically matched stem cells without cloning a human embryo would receive a prize of $20 million. NIH would develop the boundaries of the competition with the restriction being that the research could not violate the terms of the Dickey Amendment. Once ANT or one of the other alternative methods was successful and we had a proven means to get genetically matched stem cells without cloning a human being, the NIH could issue regulations requiring science to use that technology in its research.

The idea of a competition is not new. They have successfully been used for centuries to educate, inspire, and motivate. For example, Charles Lindberg won a $25,000 prize for the first nonstop flight between Paris and New York in 1927. In 2004, a company called Scaled Composites won a $10 million prize for the first privately funded manned suborbital flight from the St. Louis-based X Prize Foundation. Inspired by the success of the X prize--and with the support of Congress, the President and his Commission on Implementation of U.S. Exploration Policy--NASA has begun a federally funded program called Centennial Challenges that awards prizes to stimulate innovation in technical areas of interest to space exploration. In fact, the program manager at NASA, Brant Sponberg, said they expect to spend $80 million on prizes over the next 5 years.

Since the competition allows for funding of all possibilities, and not just ANT, I support what Talent has put forward.

I called Senator Talent's office and alerted his staff to S.1557, which his comments suggest he would support.

The complete speech, for those who care to waste some time:

Mr. TALENT. Mr. President, 9 years ago, scientific advances in the technology of nuclear transfer permitted the cloning of a sheep named Dolly. The immediate reaction of most Americans, and most Members of Congress, was to try to make certain that this process was never used to create a human being, never allowing a human Dolly to be cloned. I remember thinking at the time that I personally did not want to live in a world where I was walking down the street and saw myself coming in the opposite direction.

Why this reaction? After all, cloning is an acceptable thing in the agricultural world. The difference, of course, is that human beings have a unique dignity. When parents decide to have a child, they do it for the benefit of the baby, to nurture that new life to live up to the potential and live out the plan which God created for him or her. All of us agree that people should not be cloned because the only reason you clone something is to use it, and human beings should and do exist for reasons of greater dignity than simply to be used by others. I think we all understand that if we were ever to allow a race of clones to be created as workers or body parts warehouses for society, we would cheapen the dignity of humanity to the point where none of the rest of us would be safe in our lives or freedoms.

Yet, despite this shared impulse against cloning, it has been 9 years since Dolly was created, and no safeguards against cloning have passed the Congress. Nor are there prospects of any such bill passing in the near future. The reason is that there is an area of overlap between the issues of cloning and stem cells. Many scientists believe that stem cells from a cloned human embryo may have unique advantages for medical research. This part of the scientific community has resisted the total ban on cloning which has been introduced each of the last 6 years in the belief that such a ban would inhibit one important aspect of stem cell research. Both sides have settled into what has now become a rigid stalemate, like the Western Front in WWI. Even though the idea of cloning human beings is morally repugnant to most of us, there is currently no Federal prohibition or even regulation of any aspect of human cloning, or for that matter of warehousing body parts and creating ``fetus farms,'' and no prospect of getting such prohibitions.

I have spent the better part of a year researching this issue, meeting with people on all sides: groups who oppose cloning embryos to get stem cells, scientists who support it, parents who don't know who or what to believe but who are desperate for a cure for their children. Many to whom I have spoken have strong opinions about the underlying moral issues. In every case, I respected the sincerity and passion of those whom I spoke with. I have strong opinions of my own.

I believe human beings are precious. I am concerned about the tendency of our society to devalue people because they are too old, too young, or too inconvenient to have around. At the same time, I understand the desperation of parents whose children are sick or dying and who are desperate for treatments that will make them well. I often tour neonatal units. It breaks my heart to see children there fighting for life. I also meet with kids who are struggling heroically with chronic disease. I want to find cures for these children--but I also want them to grow up in a society that values them for their inherent dignity, for who they are, regardless of their age, infirmity, or level of achievement in the world's eyes.

Just because we are deadlocked about what to do in the present is no reason we cannot agree on what we want the future to be. We find ourselves at the beginning of a great new era of biology. I believe we can and should determine what our children's future will look like, and what objectives we want for our Nation. And, clearly, for all of us this would include progress in biomedicine built upon a solid foundation of moral principles in defense of human dignity.

I have come to the floor of the Senate today because there are just such hopeful prospects for the future. As is so often the case, the technology that generates the problem may also provide the solution. Just as recent scientific advancements created a moral dilemma, discoveries that are even more recent may provide a way out. Within a short time, it may be possible to get the exact stem cells researchers say they need without cloning an embryo. This means that we need no longer argue about such important but difficult questions as whether an embryo is fully a person or whether and when stem cell research may actually produce medical cures. The good news is that we can effectively prohibit human cloning and do it with a consensus that heretofore has not been possible; we can honorably reconcile our positions without requiring anyone to compromise their principles--provided that we are willing to approach the cloning issue humbly and practically, and provided also that both sides really do want what they say they want.

Mr. President, one of the difficulties with this issue is that much depends on understanding at least the basics of the science involved, and the science is complicated--especially for those of us who limped through high school biology. So I want to review some of the facts about stem cells and in particular about how stem cell research intersects with cloning.

A stem cell is a cell that does not itself perform a physiological or structural function in the body but instead serves as a source for cells that do perform such functions. During early development, stem cells help form the human body; in adult life, stem cells stand in reserve, to be used as needed to create new blood cells, brain cells, liver cells, and many other cells with a specific function in the body.

In current scientific language, there are two basic categories of stem cells: first, adult stem cells and, second, embryonic stem cells, which are also called pluripotent stem cells.

Adult stem cells exist all over the body. Their purpose is to maintain and repair damaged tissue. Science has known about, researched and used adult stem cells for years. To date, adult stem cell research has resulted in the development of a variety of therapeutic treatments for diseases: over 60 peer-reviewed treatments using adult stem cells exist today. These treatments include autoimmune diseases such as lupus and multiple sclerosis and blood diseases such as sickle cell disease.

A few years ago, American scientists announced that they had isolated stem cells from human embryos as well. These stem cells, called, naturally, ``embryonic'' stem cells, are the cells that, during the first days of life, begin dividing and differentiating, developing into the various parts of the body. Currently the cells can only be obtained from embryos created through in vitro fertilization, IVF. Once isolated, however, embryonic stem cells are self-replicating, which means an individual embryonic stem cell can produce tens of thousands of additional stem cells.

There is an important difference between ``adult'' and ``embryonic'' stem cells. Adult stem cells are found in the developed tissue or organs of the body and they can in general differentiate only to yield the cell types of the tissue or organ from which they came. In general, that means that an adult stem cell can become only one kind of tissue. A heart stem cell, for example, becomes heart tissue; a liver adult stem cell becomes liver tissue, and so on. Remember, the primary roles of adult stem cells are to maintain and repair the tissue in which they are found.

An embryonic stem cell, on the other hand, is considered ``pluripotent.'' That means an embryonic stem cell could develop into any of the different cell types of the body. They could in theory, if properly controlled, be commanded to become any one of a number of different tissues. This is logical, because embryonic stem cells are derived from the very cells in the embryo that are awaiting genetic instructions on what organ or other part of the body they will become. It is important to remember that the major reason science wants embryonic stem cells is because of this pluripotent quality. The fact that pluripotent stem cells come from embryos is a problem rather than a good thing, because of the obvious ethical concerns in extracting a cell from a human embryo and thereby destroying the embryo.

Whereas the value of adult stem cell research is accepted by consensus, there is more controversy over the scientific efficacy of embryonic stem cell research. The pluripotency of embryonic stem cells gives them more diverse potential, since they can in theory be ``programmed'' to become any kind of tissue. In practice, controlling pluripotent stem cells enough to produce actual treatments has been very difficult, and researchers to whom I have spoken, while supporting research with these cells, have emphasized that cures are likely to be many years away, if they come at all.

Because of this, some have argued that pluripotent stem cell research is of negligible value and that we should feel no compunction about preventing such research. But too many scientists of different backgrounds have insisted otherwise for me to be certain of that conclusion. The truth is that it is simply too soon to know whether science can control pluripotent stem cells well enough to use them for medical therapies; to the extent there is a consensus on this issue, it is that such research is speculative but promising.

Even more recently science has determined that a third category of stem cells may be useful. These stem cells are genetically matched to the patients who need the cell therapies. For several years, scientists have believed that it may be possible to derive these genetically matched stem cells through a process called somatic cell nuclear transfer or SCNT.

In SCNT the nucleus of an unfertilized human egg, which contains 23 chromosomes, is removed and replaced by the nucleus of an adult body cell. The new ``transferred'' nucleus would be genetically complete, containing all 46 chromosomes of the donor cell. This imitates the effect of normal fertilization in which the sperm's 23 chromosomes add to the egg's 23 to make the needed 46. The egg with the transferred nucleus is then stimulated and begins dividing like a naturally fertilized embryo. If all goes well, in 4 to 5 days it gets to a stage of development, called the blastocyst, from which embryonic stem cells would be harvested. These stem cells would be distinct from the embryonic stem cells derived from IVF in that they would genetically match the donor. Proponents of SCNT are hopeful that assuming they can overcome the challenge of controlling the development of any pluripotent stem cell, and assuming that they can successfully complete SCNT at all, these genetically matched stem cells would be superior to other forms of pluripotent stem cells in curing disease.

Again, stem cell research in general has nothing to do with SCNT. It is only with respect to one particular type of embryonic stem cell--a stem cell which no one has ever developed but that might have incremental advantages over other embryonic stem cells--that science wants to do SCNT. The reason SCNT is controversial is that it is a form of cloning. In fact, it is the same technique that was used successfully to create Dolly the sheep.

Both the proponents and opponents of SCNT agree that, if successful, it would result in the cloning of a human embryo.

Some supporters of SCNT, however, argue that a human embryo does not become a human being until it is implanted in a womb, and that unless researchers intend to implant the cloned embryo, SCNT should be permitted. The opponents of SCNT believe just as passionately that a human being does not depend on developmental age, and that a human embryo is therefore a human being from its beginning. From this perspective SCNT is the creation of a human being for purely instrumental use exactly what, in theory, a cloning ban is designed to prevent. But up until now, both sides have assumed that any nuclear transfer procedure which would result in the creation of pluripotent stem cells must first have produced a human embryo.

Yet the most recent scientific developments suggest that this is not true. In May 2005 the President's Council on Bioethics released a white paper entitled ``Alternative Sources of Human Pluripotent Stem Cells.'' In this report, the council outlined four specific proposals for a scientific solution to our current political impasse over stem cell research. In the months since that report was issued, progress in each of these approaches has been reported in the leading peer-reviewed scientific journals. Research on one of these proposals, altered nuclear transfer , is especially encouraging and suggests that all the scientific and medical goals of SCNT could be realized without the cloning or destruction of human embryos.

Remember, with somatic cell nuclear transfer researchers would take the genetic material out of a human egg, replace it with the complete genetic code of the donor, and then shock it so that it starts to divide. In theory, an organism created in such a way--artificially rather than naturally--could divide and grow until it became an adult human being. Altered nuclear transfer is a form of somatic cell nuclear transfer in that it uses nuclear transfer but with a preemptive alteration of the genetic material. To put it simply, the somatic cell is altered prior to being transferred. The resultant entity would be capable of producing pluripotent stem cells but because of the preemptive alterations during the transfer process it would be incapable, from its creation, of the organization and developmental potential that are the defining characteristics of an embryo.

Altered nuclear transfer is a broad umbrella concept with many possible specific approaches. For example, one proposed approach using ANT is called ANT-OAR. This form of ANT involves reprogramming the somatic cell to enter directly into a pluripotent stem cell state, without going through any of the normal developmental stages. All of this means that ANT could create genetically matched stem cells without ever having to produce anything with the capacity to be considered a human embryo.

This distinction between SCNT and ANT is vital from a moral and legal perspective. Until the last few months, everyone has assumed that nuclear transfer which was successful in generating pluripotent stem cells must first have created a human embryo. The entity which ANT could create would produce pluripotent stem cells from a laboratory-constructed cellular source lacking the developmental potential of a human embryo. In layman's terms, the entity which ANT would create could only develop for a few days and would then ``close down.'' ANT thus transcends the moral dilemma which has heretofore prevented any legislation from passing. It renders moot the question of whether human life begins at creation or implantation of an embryo since the entity that ANT could create would not have at its inception the organizational and developmental capability to be considered a human life.

Further exploration of the ANT proposal already has the support of a long list of scientists and ethicists and religious leaders, including the former chairman of the U.S. Conference of Catholic Bishops Committee on Doctrine. The author and most vocal champion of ANT is Dr. William Hurlbut of Stanford. Dr. Hurlbut assured me months ago that ANT was technologically feasible and would soon be validated through animal models. And, indeed, just 4 months ago stem cell biologists, Alexander Meissner and Rudolf Jaenisch, of the Whitehead Institute at MIT, used altered nuclear transfer to produce fully functional pluripotent stem cells from a laboratory-construct that is dramatically different in developmental potential than a natural embryo. In testimony to an October 2005 Senate hearing on stem cells, Dr. Jaenisch explained that this procedure is simple and straightforward and does not involve the creation of an embryo. Dr. Jaenisch said, ``Because the ANT product lacks essential properties of the fertilized embryo, it is not justified to call it an ``embryo.'' That was October 19, 2005 testimony at an Appropriations Subcommittee on Labor, Health and Human Services, Education hearing on ``An Alternative Method for Obtaining Embryonic Stem Cells.'' This scientific advance was widely reported precisely because it signals the end of the ethical dilemma in this area of research; it suggests that science may soon be able to get this special kind of stem cell--pluripotent stem cells that genetically match the donor/patient--without cloning, creating, or destroying a human embryo.

Mr. President, I appreciate the patience of the Senate in bearing with me as I wound my way through the scientific thicket. I believe it was necessary to lay this foundation before proceeding, and I suspect that the Senate may already see the practical suggestion which I see as the logical result given the latest technological developments and the current stalemate.

Again, to reaffirm my central point, many scientists have resisted a total ban on human cloning because they believed it was necessary to clone human embryos for a narrow purpose: to get pluripotent stem cells which are a genetic match of the person whom they hope to treat medically. However, it now appears that it will be possible to get such stem cells without cloning an embryo.

Some may argue that these alternative forms of nuclear transfer and other new technologies are unproven and may never produce usable new discoveries. But the same thing can be said of embryonic stem cell research in general and SCNT in particular. Bear in mind that science has yet to succeed in getting pluripotent stem cells from SCNT at all. Nor, for that matter, is there a single new cure from

embryonic stem cells derived from any source. If researchers cannot learn how to isolate and control genetic signals, then pluripotent stem cell research will turn out to have little medical application; if such control does prove possible, then there should soon be no reason to have to get the stem cells by a method that clones or destroys a human embryo.

As I mentioned earlier, we appear to be at a legislative stalemate. The key to reaching the proper legislative solution, I believe, is to recognize that the new scientific developments create possibilities for an honorable reconciliation that simply did not exist at the time Senators developed and sponsored the various cloning bills that are currently introduced in the Congress. In effect, the new technology is rendering the approach of those pieces of legislation out of date.

For example, the main anti-cloning bill, S. 658, of which I am a cosponsor, would ban the use of nuclear transfer whenever it resulted in the creation of a human embryo or an organism that was ``virtually identical'' to a human embryo. This standard satisfies one of the important principles of the pro-life community, because it recognizes that the dignity of pre-born human beings doesn't depend on their gestational age. But it fails to account for the possibility, created by altered nuclear transfer and some of the other alternative methods, that an entity may be ``virtually identical'' to an embryo in the sense that it has a similar external appearance--and can seem to be developing as it divides--without ever possessing the inherent organizational capability to be rightly considered a human being.

Because of this, there is a danger that the language of S. 658, which was adequate when we all assumed that any entity capable of creating embryonic stem cells must be a human embryo, would outlaw or imperil precisely those alternatives which hold the greatest promise of allowing stem cell research while protecting the integrity of human life. I discussed this problem with Doctor Hurlbut and, in a recent letter, he expressed concern that S. 658 as drafted might be misinterpreted to outlaw ANT. He pointed out that the term `virtually identical' is vague and unscientific and, therefore, could be open to misinterpretation either more broadly or more narrowly than intended by the proponents of this legislation.

The existence of alternatives like ANT actually strengthens the case of those of us who oppose the cloning of human embryos, since it promises another, ethically untroubling way of getting the same genetically matched stem cells scientists need. But it also shows that there is much about nuclear transfer that we have yet to discover, and it cautions against enacting criminal sanctions, like S. 658, that could have unintended consequences because they presume a scientific equilibrium that simply doesn't exist. Congress should still move effectively to prohibit human cloning but the approach of S. 658 needs to change. At minimum, the ``virtually identical'' language in S. 658 should be discarded, and the bill should specifically define when a cloned entity has the organizational capability and developmental potential to be considered a human being. But, I would prefer to enact a regulatory ban that could be adjusted over time to reflect changes in the science like ANT, perhaps after consultation with the President's Council on Bioethics, and I would couple that ban with aggressive funding of ANT and other alternatives, perhaps in the form of the competitive incentive program I will discuss in a moment.

The other main cloning legislation, S. 876, should, in light of recent developments, be equally unsatisfactory to many of its supporters, although for different reasons. S. 876 does not regulate the initial nuclear transfer process at all but simply bans implanting a cloned embryo. This is good as far as it goes, but S. 876 would provide no protection whatsoever to human life before implantation. Under generally accepted medical protocols today, science can't even experiment on animals if other methods of doing the same research are available, yet S. 876 would permit the cloning of human embryos for any purpose and under any circumstances, regardless even of whether the researchers need or intend to use the embryos for stem cell research.

The proponents of S. 876 were almost forced into this position to protect the stem cell research they thought necessary, because they believed, as we all did, that the only way to get genetically matched stem cells was through cloning and that any such cloning would necessarily produce a human embryo. But the evidence now suggests that this is not true. I am sure that the supporters of S. 876 are sincere in their belief that a human embryo does not acquire full personhood until some point after it is created. But I respectfully suggest that this view is no longer a reason, given the changing science, to continue supporting a legal standard that affords no dignity whatsoever to human life at its earliest stages.

The answer is for both sides to take advantage of scientific changes to find proposals which they can mutually support and which offer advantages to each compared to the current stalemate.

To that end, I propose a competition, to be managed by the National Institutes of Health, which would create incentives for our great research institutions to get the genetically matched stem cells we need without risking cloning an embryo. Simply put, the NIH would take applications from research institutions with research plans to accomplish the goal. The exact funding and practical details of this would have to be carefully worked out, but let me put forward a preliminary proposal. Five institutions would be selected for the competition and provided $10 million each to conduct their comprehensive plan. The first institution to successfully harvest genetically matched stem cells without cloning a human embryo would receive a prize of $20 million. NIH would develop the boundaries of the competition with the restriction being that the research could not violate the terms of the Dickey Amendment. Once ANT or one of the other alternative methods was successful and we had a proven means to get genetically matched stem cells without cloning a human being, the NIH could issue regulations requiring science to use that technology in its research.

The idea of a competition is not new. They have successfully been used for centuries to educate, inspire, and motivate. For example, Charles Lindberg won a $25,000 prize for the first nonstop flight between Paris and New York in 1927. In 2004, a company called Scaled Composites won a $10 million prize for the first privately funded manned suborbital flight from the St. Louis-based X Prize Foundation. Inspired by the success of the X prize--and with the support of Congress, the President and his Commission on Implementation of U.S. Exploration Policy--NASA has begun a federally funded program called Centennial Challenges that awards prizes to stimulate innovation in technical areas of interest to space exploration. In fact, the program manager at NASA, Brant Sponberg, said they expect to spend $80 million on prizes over the next 5 years.

A proposal of this kind moves us forward in a way both sides should be able to support. After all, the sole argument for SCNT is that we need it to get certain kinds of stem cells; the argument against it is that it involves the cloning of human embryos. If we can get the stem cells without the cloning, we render the current controversy scientifically obsolete. Science would have the stem cells it needs in a morally acceptable way that would allow for full Federal funding of stem cell research. The pro-life community would have an effective ban on human cloning. We would turn a zero sum game into a win-win proposition for everyone.

We are entering a promising new era in biomedical technology, but as our power over human life increases, so does the seriousness of the moral issues. It is important to acknowledge that both sides in this difficult debate are defending something important to all of us. We should all want to advance biomedical science while sustaining fundamental principles for the protection of human life.

Biomedical science should be a matter of unity in our national identity: no one should enter the hospital resentful that positive possibilities for the best therapies were not explored, or with moral qualms about the research on which their therapies have been developed.

The revelation that the South Koreans have not succeeded in obtaining pluripotent stem cells from cloned human embryo returns this research to square one. This presents to our Nation both a challenge and an opportunity: a social challenge to seek a way forward as a unified society, and an opportunity to set a solid scientific and moral foundation for future generations. The differences within our nation can be a source of strength as we seek to open a way forward for biomedical science. Altered nuclear transfer , and the other alternative approaches put forward by the President's Council on Bioethics offer us just such a path to progress.

We are at a difficult impasse, but we have extraordinary possibilities. Our current conflict reflects deep differences in our personal perspectives, but our wider goals are similar. Any purely political victory will leave our Nation bitterly divided and erode the social support that is essential for continuing public funding of biomedical science. It is with this recognition that I have put forward this proposal in a spirit of unity. And beneath this spirit of unity must be a spirit of humility: these are difficult issues and no one of us has the clarity of understanding or depth of knowledge to answer them alone. But with mutual good will we can transcend the current paralysis and find grounds for practical progress in scientific research. In his presentation on stem cell research last July to the Senate Appropriations Committee, Dr. Hurlbut said the goal should be to find ``islands of unity in a sea of controversy.'' We can move from one such island to another and end up in a world of progress and decency. There is no reason to continue glaring at each other across the legislative barricades, when the means are at hand to embrace the future of developmental biology without moral qualms or political division?

An Embryo, Defined

An Embryo.

The majority of people agree that an embryo is the first stage of life. They disagree, however, about when that stage begins.

My good friend Don Reed and I spoke for a few minutes the other day and he asked my opinion on the subject. I knew it was an entrapment question, but I couldn't immediately give a coherent response.

This troubled me, so I decided to give the question some thought.

Don proposed a few ideas, none of which I agreed with.

While discussing SCNT, he proffered that the majority of the public believe that an embryo is the product of an egg and a sperm. Did I agree? No offense, but based on the lack of basic reasoning skills prevelant among the public, I prefer not to base my judgement on public opinion.

Don also offered that an embryo isn't an embryo until implantation. Sorry, can't buy that either.

As a writer and former English teacher, it should come as no surprise that Don has a fondness for the English language. One of his most respected and trusted sources of knowledge is Webster's, the dictionary people.

Webster's published a dictionary in 2003 entitled Webster's New World Medical Dictionary. The doctors who contributed to said dictionary run MedicineNet.com, so I consulted with them on embryo. Their response?

Embryo: The organism in the early stages of growth and differentiation from fertilization to, in humans, the beginning of the third month of pregnancy. After that point in time, it is termed a fetus.

Now this wording is a little tricky, so let's take it slowly.

"The organism in the early stages of growth and differentiation"

The organism in the early stages of development. It lists fertilization as one such stage, but never specifies that fertilization is a requirement for an organism to be an embryo.

Some will argue that fertilization -- the union of the male and female gametes -- is a necessary prerequisite for an organism to be an embryo, and therefore a life. One could similarly say that, based on the above definition, an organism that does not reach the fetal stage was never an embryo, and therefore never life.

I will go out on a limb here and say that women who have suffered miscarriages in the first trimester would differ quite passionately.

Fertilization is a process that ends in the creation of a zygote. Likewise, SCNT is a process that ends in the creation of a zygote. A zygote is considered to be, quite reasonably so, an embryo.

Of course, that is my sole interpretation, based on the definition provided by the authors of Webster's New World Medical Dictionary.

But, what if I am wrong? I always consider that to be a realistic possibility.

Consulting another source in the same family, what does Merriam-Webster have to say?

Embryo: 1 a archaic : a vertebrate at any stage of development prior to birth or hatching b : an animal in the early stages of growth and differentiation that are characterized by cleavage, the laying down of fundamental tissues, and the formation of primitive organs and organ systems; especially : the developing human individual from the time of implantation to the end of the eighth week after conception

Apparently, Webster cannot agree with Webster. Is Webster suffering from a multiple personality disorder? A family dispute?

Or, is the definition of embryo not quite settled?

Senator Talent Screws Up

Missouri Senator Jim Talent recently announced that he was dropping his support of the Human Cloning Prohibition Act because he now favors an alternative method of deriving embryonic stem cells known as Altered Nuclear Transfer (ANT).

I will get to ANT in a minute, but first I want to focus on the good in something Talent said. He proposed that the NIH fund 5 centers, to the tune of $10 million each, to further develop the ANT procedure for human use. The first center to do so will receive a $20 million prize.

While I am no fan of the government funding an X-prize like competition, I think this is a positive step. Like Senators Tom Coburn and Jim DeMint, he is proposing funding for research into alternative derivation methods. In itself, this is a great thing.

Now, the bad.

ANT has been referenced here before, but not too kindly. The belief that life begins at conception and support for ANT cannot, in my mind, coexist in the mind of a rational person.

The product of conception is a zygote. The product of somatic cell nuclear transfer (SCNT) -- when an egg is the recipient cell -- is, at least functionally, a zygote. Similarly, the product of ANT is functionally equivalent to a zygote.

If a person believes that a zygote is the first stage of life, then they must oppose both SCNT and ANT to remain logically consistent.

But, that's not even what riles me up the most. A Senator should not use legislation to force scientists to research only one option. If Talent had suggested using money to, generally speaking, fund research into alterntive methods of generating ESCs, I would have loved it. But, he had to go and attach ANT to it.

Transdifferentiation Occurs Naturally

Transdifferentiation occurs "naturally" in a disease process that mimics asthma and COPD.

In mice with a chronic lung condition resembling asthma and chronic obstructive pulmonary disease (COPD), the researchers saw that the airway lining maintained an overabundance of mucus-producing cells (called goblet cells for their cup-like shape). Further investigation showed that goblet-cell buildup resulted from two cellular mechanisms. One mechanism allows for the prolonged survival of cells with cilia, tiny hairs that help sweep debris out of the lungs. The other mechanism encourages the ciliated cells to transform into goblet cells.

...

The second inhibitor the researchers tested interferes with signaling pathways activated by an immune-system protein known as interleukin-13 (IL-13). They found that IL-13 elicited the crucial change from ciliated to goblet cells in mouse airways and human airway cells in culture. Interfering with IL-13 prevented this transformation from one cell type to the other--a process known as transdifferentiation.

Transdifferentiation is bad, in this instance, but controlled, it would be a useful technology.

State of the Union Redux

Lashing out against "egregious abuses of medical research" during his State of the Union Address, President Bush set the stage for the embryonic stem cell debate in 2006. This year, the battle continues.

Specifically, Bush said:

Tonight I ask you to pass legislation to prohibit the most egregious abuses of medical research: human cloning in all its forms, creating or implanting embryos for experiments, creating human-animal hybrids, and buying, selling, or patenting human embryos. Human life is a gift from our Creator -- and that gift should never be discarded, devalued or put up for sale.

Before I attempt to predict the future, I need to nit-pick for a second.

There are a two things here that I, for one, have never heard of: no scientist in the US, to my knowledge, has proposed implanting an embryo for experiments; and no scientist or business has proposed patenting human embryos, although they have proposed patenting embryonic stem cell lines. Big difference. These two claims look like scare tactics to me.

With that out of the way...

Bush basically reiterated his August 9, 2001 statements, which does not bode well for the Stem Cell Research Enhancement Act. Many SCREA proponents are hopeful that Bush will fail to issue his promised veto, since the bill only allows federal funding for ESCs derived from embryos where "the life and death decision has already been made." But, Bush addressed this in 2001:

And to the other crucial question, if these are going to be destroyed anyway, why not use them for good purpose -- I also found different answers. Many argue these embryos are byproducts of a process that helps create life, and we should allow couples to donate them to science so they can be used for good purpose instead of wasting their potential. Others will argue there's no such thing as excess life, and the fact that a living being is going to die does not justify experimenting on it or exploiting it as a natural resource.

Bush has made it clear that he sides with the group dubbed "Others," so the chances that he would sign it in to law or allow it to become law without his signature are only slightly lower than they are for me to get up and walk tomorrow. Which, I am sorry to say, I would not bet on.

So, what are we left with? The so-called "decoy" bills.

SCREA supporters claim that other bills, such as the Respect for Life Pluripotent Stem Cell Act, are just smoke screens meant to divert attention away from the SCREA and allow legislators to "pretend" to support ESC research. For election reasons. And stuff.

Which, to me, sounds like spilt milk. Imagine a kid going to their parent and saying "I want $20!" The parent says "No, but I'll give you $5." The smart kid would accept the $5 and say "Oh, okay." But, a bratty kid would whine about not getting their way and end up with nothing.

So, SCREA supporters, are you smart or bratty?