HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Wednesday, November 28, 2001

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[English]

The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Good afternoon, ladies and gentlemen. It's my pleasure to call this meeting to order.

Before I introduce the witnesses, I'd like to welcome on your behalf a group of international visitors who have come from the Ukraine and have decided they would like to observe the committee in action. Welcome to you all.

Our first presenter today is Dr. David Prentice, a professor of life sciences at Indiana State University.

Dr. Prentice, the floor is yours.

Professor David Prentice (Faculty of Life Sciences, Indiana State University): Madam Chair and distinguished members of the committee, thank you for the opportunity to provide testimony on this important subject.

The first question is, why use stem cells? The short answer is, to treat degenerative diseases. In the past, infectious diseases were the scourge of mankind. Antibiotics, vaccinations, and sanitation have dealt with these as killers. Today, degenerative diseases such as heart disease, stroke, chronic lung disease, and diabetes are our main concern. While my chart details the leading causes of death in the U.S., these are common to all industrialized nations. In degenerative diseases, the tissue dies slowly. Stem cells are proposed to treat these diseases by repairing and replacing the damaged tissue.

A stem cell has two chief characteristics: one, it multiplies, maintaining a pool of stem cells; and two, given the correct signal, it can differentiate into other specific cell types for use by the body. There are several sources of stem cells—and in addition to my written testimony, I have given the clerk some charts and references to which I'll be referring.

The two types of stem cells that have been most in the news are embryonic stem cells, derived from the very early embryo, five to seven days after conception, and so-called adult stem cells, which reside in most, if not all, tissues of the body. Adult stem cells are actually present from the moment of birth and could more properly be termed tissue stem cells or postnatal stem cells, including umbilical cord blood stem cells and placental stem cells.

Embryonic stem cells are derived by removing the inner cell mass of the early human embryo. In this process, the embryo is destroyed. The cells are placed into culture, and their purported advantages are that they can proliferate indefinitely and can form any tissue. Scientific papers support the claim that they can proliferate for long periods of time in culture. In theory, they can form any tissue; however, the basis of their potential to form any tissue relies on the cells remaining within the embryo, where they form the range of tissues and organs of the human body during normal development.

However, claims for embryonic stem cell advantages over adult stem cells are unsubstantiated. There are no current clinical treatments based on embryonic stem cells, and there are in fact very few published successes using animal models of disease. In fact, those who work with embryonic stem cells even have difficulty obtaining pure cultures of specific cell types in the laboratory dish.

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For example, an Israeli group reported this past summer that they had obtained insulin-secreting cells from human embryonic stem cells. While this might initially sound like a potential treatment for diabetes, what the popular press did not report, and what was revealed by the scientific paper, was that only 1% of the cells in the culture dish secreted insulin. The remaining 99% of the cells were a mixture of other cell types, including nerve, muscle, a few beating heart cells, and also cells that continued to proliferate. In fact, those growing cells point out another problem with embryonic stem cells: the potential for tumour formation.

Proponents of embryonic stem cell research readily admit that when injected into animals, embryonic stem cells tend to form tumours. Embryonic stem cells are actually difficult to establish and maintain in culture. James Thompson, who originated the first human embryonic stem cells in 1998, required 36 human embryos to obtain five stem cell lines. Each stem cell line derives from one embryo. The Jones Institute in Virginia, in the summer of 2001, used 110 human embryos to derive three stem cell lines. In addition, embryonic stem cells face a significant risk of immune rejection. Tissue formed from embryonic stem cells will thus be rejected like most organ transplants without a precise tissue match.

This past summer, a group from the Whitehead Institute reported that embryonic stem cells are actually genomically unstable, meaning that the expression of their genes is unstable. This might in fact explain why there is such difficulty in obtaining pure cultures and why they tend to form tumours.

It is illustrative to examine some quotes from proponents of embryonic stem cell research. In a recent review paper co-authored by James Thompson, the following are noteworthy:

Rarely have specific growth factors or culture conditions led to the establishment of cultures containing a single cell type.

Furthermore, there is significant culture-to-culture variability in the development of a particular phenotype [or cell tissue type] under identical growth factor conditions.

[T]he possibility arises that transplantation of differentiated human ES [embryonic stem] cell derivatives into human recipients may result in the formation of ES cell-derived tumours.

And finally:

[T]he poor availability of human oocytes, the low efficiency of the nuclear transfer procedure, and the long population-doubling time of human ES cells make it difficult to envision this [meaning, the generation of human embryos by nuclear reprogramming] becoming a routine clinical procedure.

From a paper including researchers from Israel and Harvard University:

The work presented here shows that none of the eight growth factors tested directs a completely uniform and singular differentiation of cells.

A commentary in the journal Science included the following quotes:

[M]urine ES cells [that is, mouse embryonic stem cells] have a disturbing ability to form tumours, and researchers aren't yet sure how to counteract that. And so far reports of pure cell populations derived from either human or mouse ES cells are few and far between—fewer than those from adult cells.

In that same report is this quote from Harvard's Douglas Melton:

Bone marrow stem cells can probably form any cell type.

And from a paper mentioned previously from the Whitehead Institute:

The epigenetic state [meaning, the ability to express genes] of the embryonic stem cell genome was found to be extremely unstable.

Thus, there are in truth few actual positive published scientific papers regarding the claims put forth for embryonic stem cells and a significant number of negative characteristics. Too often a false choice has been put forth: that we must either destroy embryos or allow patients to die. However, there are other choices and alternatives, in particular adult stem cells or tissue stem cells. A wealth of scientific papers published over the last few years, many within just the past year, document that adult stem cells are a much more promising source of stem cells for regenerative medicine. Adult stem cells actually do show pluripotent capacity in generation of tissues, meaning they can generate most, if not all, tissues of the body.

In a paper published in May, the researchers found that one adult bone marrow stem cell could regenerate not only marrow and blood, but also form liver, lung, digestive tract, skin, heart, muscle—in essence, virtually all adult tissues. Since that one adult stem cell came from a mouse and was transplanted into another mouse, it might be termed “mouse-to-mouse resuscitation”. In addition, a report last year showed similar results for brain stem cells.

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Appendix C shows examples of tissues from which adult stem cells have been isolated, shown in red, as well as some of the derivatives from those stem cells—and it is not an all-inclusive chart. Bone marrow and brain stem cells seem particularly “plastic”, potentially with the ability to form all adult tissues. Even fat has been found to contain stem cells that can be transformed into other tissues. For my own country, this could constitute an unlimited supply of stem cells. In point of fact, any time someone has looked in a tissue for stem cells, they've found them. In my own laboratory, we isolate stem cells from blood and are transforming them into nerve cells.

I might point out that the work on the chart of skin stem cells transforming into other tissues was done by Freda Miller at McGill University. And there was a report two days ago in The Journal of Cell Biology where researchers transformed bone marrow stem cells in mice into functional cells called Purkinje's cells. These are cells in the brain that are responsible for coordination of movement. So we have a potential treatment now for diseases in which there is an uncoordination.

Many published references also show that adult stem cells can multiply almost indefinitely, providing sufficient numbers for clinical treatments, and in fact, adult stem cells have been shown to be effective in treating animal models of disease, including such diseases as diabetes, stroke, and heart disease. Some of the best work done in terms of turning muscle or bone marrow stem cells into heart tissue has been done by Ray Chiu, also at McGill University.

Moreover, adult stem cells are already being used clinically for many diseases. These include as treatments for various cancers; auto-immune diseases such as multiple sclerosis, lupus, and arthritis; anemias, including sickle cell anemia; and immunodeficiencies. More importantly, adult stem cells are being used to transform from one tissue into another in treatment of diseases, including formation of cartilage, growing new corneas to restore sight to blind patients, treatments for stroke, and two groups—one in Germany and one in France—have used adult stem cells to repair damage after heart attacks. Further clinical trials are already under way. Skin can actually now be grown simply by plucking a few hairs, because the skin's stem cell resides in the hair follicle. Another advantage of using adult stem cells is that the patient's own stem cells can be used for the treatment, preventing the problems of immune rejection.

Adult stem cells actually appear capable of interconversion between different tissues. Thus, the old idea that cells gradually become more and more limited as they develop appears to be incorrect, and instead, cells appear to retain the ability to differentiate into various cell and tissue types.

One proposal, based on numerous studies, suggests a common adult stem cell that can migrate via the bloodstream to the tissues. Once entering a tissue, the stem cell takes cues from the local environment to become that tissue type.

More scientists now admit that adult stem cells will be the ones to provide therapeutic benefits to patients. However, some still maintain that it's necessary to study embryonic stem cells and their developmental signals in order to understand how to produce adult stem cells and how to use them in treatments. This makes neither logical nor scientific sense. Since adult stem cells have already shown their versatility and ability to grow in culture, directly studying adult stem cells is a more efficient route to understanding and utilizing these cells.

Turning briefly to the issue of cloning, virtually all reputable scientists reject the notion of cloning a human being to produce a live birth. However, some advocate the use of human cloning to obtain embryonic stem cells, through a process euphemistically termed “therapeutic cloning”. The procedure is certainly not therapeutic for the cloned embryo and should more properly be termed “experimental cloning”. The rationale is that by cloning the patient, destroying the cloned human embryo to obtain the stem cells, and then using those cells to produce tissue, the tissue might be a perfect match for the patient. In fact, there is scientific evidence that this will not be a perfectly matched tissue, since the egg used for cloning will also contribute to the embryo's makeup. And as we have discussed, the embryonic stem cells themselves are unstable and potentially dangerous.

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As a reminder of the cloning procedure, the genetic material of an oocyte or egg is removed, and the genetic material of a cell, such as a skin cell, is then inserted into the egg. I would point out that the process as well as the product is the same up to the early embryo stage, whether the cloning is intended to result in a live birth or in derivation of stem cells, and in fact the embryo at that stage, whether produced by cloning or by the old-fashioned method of joining egg and sperm is the same. Embryos produced by the different methods could not be distinguished under the microscope.

For embryonic stem cells and their claims, we must then consider not only the promises but also the premises and published data as supporting or refuting the claims. There is actually little published scientific data to support the claims for embryonic stem cells. It would in fact be unethical to destroy human embryos for stem cells if there is a viable alternative, which has already been established by a wealth of published scientific evidence about adult stem cells. It would also be unethical to experiment with humans before work is verified in animals.

Doctor Thompson derived primate embryonic stem cells before deriving human embryonic stem cells, and mouse embryonic stem cells have been in use for 20 years; these cells should be used to substantiate claims before relying on destruction of human embryos. It is also unethical to use embryonic stem cells because the cells pose significant health risks, including tumour formation, transplant rejection, and instability in gene expression. In fact it is unethical to fund embryonic stem cell research since it would divert limited funds to less promising research and potentially delay disease cures.

In summary, adult stem cells have been shown by the published evidence to be a more promising alternative for treatments with a vast biomedical potential. Adult stem cells have proven success in the laboratory dish, in animal models of disease, and in current clinical treatments. Adult stem cells also avoid problems with tumour formation, transplant rejection, and also with the ethical quandary of destroying some human beings for the potential benefit of others.

Attached to my written submission, I've provided a lengthy list of references regarding scientific advances in adult stem cell research for the committee. I also apologize; I did not get into my textual statement the recommendations that were requested for the committee, and I would like to make eight recommendations: one, a total ban on human cloning for any purpose; two, prohibit production of embryos by any means for research purposes; three, prohibit destruction of human embryos for research purposes; four, prohibit the introduction of genetic material into the human germ line, also known as “heritable gene engineering”; five, prohibit the production of animal-human hybrids, also known as chimeras; six, regulate the production of IVF embryos, promoting instead oocyte freezing rather than embryo freezing; seven, promote embryo adoption alternatives, such as the Snowflake Embryo Adoption Program; and eight, place a priority on adult stem cell research.

Madam Chair, distinguished members, thank you once again for allowing me to present testimony on this issue, and I'd be pleased to answer any questions.

The Chair: Thank you very much, Dr. Prentice. It was most enlightening.

We'll begin now with the questioning, and we'll begin with Mr. Manning.

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Mr. Preston Manning (Calgary Southwest, Canadian Alliance): I would like to thank you, Dr. Prentice, for being with us. I find your presentation very helpful, and I personally find myself in agreement with a lot of what you've said. Will you be giving us those last eight recommendations in some form, so we'll be able to get those?

Prof. David Prentice: Yes, sir. I've provided a copy to the clerk and he will be providing that to the committee.

Mr. Preston Manning: My first question is a general one, but when we consider this subject of stem cell research, I think a lot of us see that there is a moral and ethical problem with the embryonic stem cells that is resolved to a large extent if you can do the same things through adult stem cells. That is a case then of science itself providing an answer to a moral and ethical dilemma.

I wonder, before I get into the particulars on stem cell research, are you aware of other instances where by funding science in a particular direction you actually overcome the moral and ethical dimension of science in another direction? I think as a general principle, if one can give lots of illustrations of that, it suggests certain directions to us.

Prof. David Prentice: I'm not aware immediately of any particular example, though I think as a general principle, because we all have limited funds to invest in the research enterprise, if we try to cover everything at once in the hopes, no matter how slim, that we might come up with various cures for diseases and so on, we tend to dilute our efforts in terms of the most promising and demonstrably most successful research.

Mr. Preston Manning: If in the future you can think of any other illustrations, it would be helpful to us. The main one is the adult and embryonic stem cells, but if you can think of other illustrations, I think that could be useful to us in talking to our political colleagues.

Prof. David Prentice: I have one that's not necessarily the positive aspect, but the negative. In one sense, we've gone through this same debate about ten years past in terms of fetal tissue research. A great deal of money was poured into research to transplant not stem cells but already-formed tissue from fetuses. The examples would be for pancreatic tissue for diabetes, brain tissue for Parkinson's, and so on.

There was a published report this past spring in the New England Journal of Medicine that documented a controlled study, actually the first controlled study, from this wealth of money poured into the research. The results were that for the most part there were no positive effects whatsoever for the patients who were treated for Parkinson's with this transplanted fetal brain tissue. In 15% of the patients, the transplant actually made them worse in an irreversible fashion.

So in that particular instance, we could say that we've put money into the wrong avenue of research, based again on similar types of premises as we see with the embryonic stem cell research.

Mr. Preston Manning: Our bill does not specifically mention stem cell research, and yet it's a very current topic. The principles we establish in relation to it would presumably have application in other areas as well. Would you recommend that in the section of our bill dealing with regulated activities, we actually treat stem cell research as a particular category and provide specific guidelines and regulations with respect to it? No doubt there are pros and cons about that, but would you generally favour that?

Prof. David Prentice: I think it certainly would be helpful, especially in terms of promoting and encouraging the adult stem cell research. As you're all well aware, it's obviously a very complex subject that is difficult to get your mind around with all of the various possibilities and all of the questions, some of which still remain unanswered. Because of that, I think it would be helpful potentially to treat this as a separate issue.

Mr. Preston Manning: Lastly, are you aware of any protocol or guidelines...? Suppose we did that; suppose we create a section for general principles for guiding stem cell research. Are you aware of a protocol that would state something to the effect that where there are two alternative lines of research and one has more ethical and moral problems than the other, the regulator should direct activity in the direction of the research that is least problematic from a moral and ethical standpoint? Are you aware of guidelines anywhere that state that principle, perhaps in a more legally and scientifically acceptable way?

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Prof. David Prentice: Well, I'm not sure about legally acceptable, but I think Hippocrates said it quite well, that in matters of medical treatment you should first do no harm.

Mr. Preston Manning: Okay. Thank you.

The Chair: Mr. Lunney.

Mr. James Lunney (Nanaimo—Alberni, Canadian Alliance): Thank you, Madam Chair, and thank you, Dr. Prentice, for a very interesting presentation.

I would just suggest that on this controversy over whether you use embryonic stem cells or adult ones, we had a group that testified before us just recently from the Juvenile Diabetes Association, and they were quite determined that they needed embryonic cells.

We're dealing with this issue where there's a lot of scientific hype placed on these embryonic stem cells. I think what we see in your presentation today and as we heard yesterday from another witness.... In fact, a witness we had yesterday, who was also an expert in epidemiology, said that in 20 years of embryonic stem cell research in mice—I believe, to use her words—we'd been more or less sold a bill of goods. In 20 years they had failed to deliver in that area, and it was strange that they're still trying to deliver that package with human cells, saying these would suddenly deliver what mouse cells have failed to do.

I'm just interested in some of the facts you've brought out here about our recent advances in adult cells—very recent. In the last six months or a year, perhaps, we've had such tremendous breakthroughs. Even the research you've mentioned here is all very current, and I thought it was particularly interesting when you mentioned that you might find stem cells in skin cells that are as easily accessed as by pulling out a hair follicle. In your opinion, is it more likely that the tremendous benefits that have been promised through embryonic stem cells are much more likely to be delivered through adult stem cell research?

Prof. David Prentice: I think it's almost a given that these therapeutic treatments will come from adult stem cells rather than embryonic. In fact, in some of the debates I've had with proponents of embryonic stem cells, they've admitted that the therapeutic benefits will come from the adult stem cells. The question then arises, why continue to push for human embryonic stem cell research? Their answer lies in this question I mentioned during my testimony, the idea of trying to discern the particular pathways or genes necessary to get differentiation of one cell type into another.

Again, I'd just point out that it makes no sense logically to have to go back to the very beginning of a process and try to determine how to get an adult stem cell so we can then use it. We already have the adult stem cells easily isolated in many cases. They are easily grown in culture, and there are indications that we can transform those adult stem cells into virtually any tissue.

Mr. James Lunney: I heard the words “easily grown in culture”, yet some of the testimony we heard from other researchers was that in fact adult cells are not easily grown in culture. They seem to think that embryonic ones grew more profusely in culture. Do you have some evidence or information to support that?

Prof. David Prentice: Yes, sir. I think this has primarily been a technical problem along the way. My own country's National Bioethics Advisory Commission studied this question, and when they issued their report in September 1999, they pointed out that it was not justifiable to use human embryos for research if there was a less morally problematic alternative. But at that point in time there was no scientific evidence, or certainly not much scientific evidence.

As you state, most of these results have come out probably within the last six to twelve months. The timeframe here then is very short, and perhaps many scientists are not even aware of some of the indications. But in fact on the slide I had up about the cells being able to multiply almost indefinitely.... This is from a paper that came out at the beginning of this month. Now, there were a wealth of references before that indicating that adult stem cells could be grown quite well in culture.

Actually, one of the references is, I believe, from Ray Chiu's lab at McGill, but this most recent reference involving bone marrow stem cells essentially answers that question. One of the advantages of embryonic cells was supposedly that they can be grown forever in culture, if of course you could get them into culture, which they've had difficulty doing, as I mentioned before. There's no disputing that they can continue to grow in culture.

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One of the questions is, how do you stop them and get the tissue you want and not a tumour? There is no evidence of tumour formation from any transplant of an adult stem cell. They can be grown in culture to get clinically usable amounts of tissue, and already have been in fact. This past summer I testified in my House of Representatives alongside a young man 16 years of age who had had a relapsing leukemia. The young man was treated with umbilical cord blood stem cells at the age of 14. Two years later he was cured. They had to grow some of those cells in the laboratory so they would have enough because he was somewhat large for his age.

This past summer the New England Journal of Medicine reported treatment of somewhere around 50 adult patients for various cancers using umbilical cord blood stem cells, again requiring growth of the cells in culture. It's simply a false assumption that adult stem cells cannot be grown to usable amounts in culture.

Mr. James Lunney: Just on that line, could you clarify the fact that obviously these cells from umbilical cord blood were not autologous? Of course you're transplanting into other patients. Would they then be required to take anti-rejection drugs?

Prof. David Prentice: It turns out that it's fairly easy to get a match with umbilical cord blood stem cells as opposed to cells from other tissues, even bone marrow. There are fewer needs for match, and also the cells are naive. Your and my immune systems have been exposed to various diseases such as colds and to allergens like pollen and dust, but the umbilical cord blood stem cells have not acquired those particular types of sensitivities, so they're much easier to manipulate in terms of treating patients.

Mr. James Lunney: Given that, it's quite interesting that researchers wouldn't be gung-ho to really pursue that avenue rather than go after embryonic ones, which are still very aggressive.

Prof. David Prentice: Right. Another possible recommendation would be to set up a public umbilical cord blood bank, because most of the umbilical cords and the placentas are simply thrown away. In fact, for this young man to get a match—even though it doesn't have to be a very close match—they had to fly the umbilical cord in from Spain. We're pushing in my own country to get a public umbilical cord blood bank for these same reasons.

Mr. James Lunney: Thank you very much.

The Chair: Thank you, Mr. Lunney.

Madame Picard.

[Translation]

Ms. Pauline Picard (Drummond, BQ): Good day.

You are recommending that we prohibit the altering of germ cells. However, some scientists think that this is a way of curing hereditary or genetic disease. Why are you recommending this?

[English]

Prof. David Prentice: For stem cell treatment or, more usually, for genetic engineering replacement for heritable illnesses, the concern is not with treating the already-born individual. The concern is with altering the egg, the sperm, or the very early embryo so changes might then be passed on to future generations. It's not a concern that revolves around eliminating the genetic disease. The concern has to do with how much we actually know in terms of being able to make changes that would be passed on to future generations.

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The current number of human genes is somewhere around 70,000. That number keeps changing as the genome project continues. Those genes must all interact in a carefully orchestrated balance of genes, cells, and tissues during development. I don't believe, at this point in time, we are wise enough to know how to eliminate one particular gene without potentially causing trouble with the other almost 70,000.

It is interesting, too, as we gain understanding of some genes that we thought were solely dangerous, that they may also be used in other ways within the body. One good example is the sickle-cell gene. It turns out that it's protective against malaria. Totally eliminating that gene from the human gene pool, therefore, may not be a wise thing to do, at least to pass on that deletion to future generations.

Instead, my proposal would be that we do somatic genetic engineering in which, once we have the individual, we can make those changes in the genome and repair the defect.

I might point out that the first successful human genetic engineering experiment was done approximately a year and a half ago in France with little children, infants who have what is usually termed the “boy in the bubble” syndrome. They have a severe immune deficiency. The way they repaired that defect was to take adult stem cells, bone marrow stem cells from the infants, replace the gene in culture, and put it back into the infants. As far as we can tell, they are now cured of that defect.

[Translation]

Ms. Pauline Picard: I have another question, Madam Chair.

Last weekend, some newspaper articles said that a pharmaceutical or a laboratory company—I think that it was Advanced Cell Technology in the United States—had succeeded in cloning human embryos. You certainly saw those articles. Could you explain what happened? I am asking you that because other articles later said that it was not really serious. In any case, I find it difficult to understand what happened. Did they really succeed in cloning human embryos?

[English]

Prof. David Prentice: Yes. Actually, I've even debated Michael West, the president of that company, a couple of times.

I think the short answer would be that yes, Advanced Cell Technology did clone a human embryo. This is the first published scientific report of that. I might point out that approximately two years ago that same company cloned a human embryo by taking the genetic material from a human cell and putting it into a cow egg. They obviously didn't report that in the scientific journals.

Technically, you could say they had cloned a human embryo. There were actually three results within that paper. I might add that, scientifically, there's some concern because there were very few real results. It was a very quickly rushed paper, probably to stake the scientific claim for that company.

In one instance, they cloned a human embryo by taking the nucleus of a skin cell and putting it into an egg. In point of fact, that one-cell clone never actually divided into two cells. In a sense, that was the failure.

In another instance, and the actual success, they took a very small cell called a cumulus cell, which is a cell that is ovulated with the egg, and used that genetic material in the egg. That is the embryo clone that actually made it to six cells. In point of fact, they did clone then and were able to get some limited embryonic development. But stopping at six cells did not actually achieve the result they were after, which was to form that hollow ball with the cells in the centre from which they could obtain embryonic stem cells. The embryo did not make it near that point.

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There was actually one other result within that paper, and I've seen the entire paper. I quickly downloaded it as soon as their news reports came out. This was production of a human embryo, not by cloning but by a process called parthenogenesis, in which the egg does not have its genetic material removed. Instead, it is fooled into doubling that genetic material, so there is a complete set of human chromosomes. Those embryos developed to the point at which there was a hollow ball, so there was more embryonic development. But, in a sense, that was also a failure because those hollow balls were empty. They did not contain any embryonic stem cells.

I think the bottom line would be to say that Michael West and Advanced Cell Technology are the first to publish cloning of a human embryo. The results are not very good. To say that there is no import in this simply ignores the obvious hype that we've seen in the news over it and the potential down the road that this technique could be used to produce human embryos, whether for stem cells or for implantation for a live birth.

[Translation]

Ms. Pauline Picard: In your opinion, why do some scientists insist so much on working on embryo cells while the same results can be obtained with adult stem cells? Why do they insist so much on working on embryos when this really raises ethical issues? I my opinion, we do not know where the limits are. Is this not an assault on human dignity? What is motivating them to do this work while we can get results with adult stem cells?

[English]

Prof. David Prentice: I think there are several possible motives, and I would not impute any particular motive to one group or persons, but we can make some assumptions.

Scientific success and scientific fame or status, if you will, is measured by the scientific papers you publish and the grant dollars you accrue. So the push to work on embryonic stem cells—I'm aware of at least in my country—was largely directed at accruing billions of federal grant dollars and certainly to be the first one to say they had done some particular scientific procedure.

I think, though, you cannot necessarily say that science is neutral in these particular aspects of using human embryos or not using human embryos. I think science itself needs to be able to take an ethical look at some of the particular experiments that are proposed. I don't believe it's the case that science progress continues and there's nothing that can be done to hinder it, especially when you look at some of the negative aspects that progress may entail.

Erwin Chargaff, who is a renowned biochemist from Germany—his work made the Watson and Crick work possible for DNA—has no particular religious aspects to bring to the debate but says there are some things science just shouldn't do.

Science tends to run away. As a scientist, I'm very curious to see what I might be able to do, where an experiment might lead. But in this particular aspect of having to destroy a human being—and let's be clear that, scientifically, even at one cell, we are a human being because of our genome; we're not a monkey, we're not a cow. But Chargaff would say that using human embryos is a form of commodification. Using them simply for the potential benefit of others, he calls a form of capitalist cannibalism. The real issue, certainly, is the ethical one. Is the young human a person or a piece of property that we can do with as we will?

I do like to come back to the scientific evidence, though, and state that despite the potential that might be out there for human embryonic stem cells, the wealth of the published scientific evidence says it is unnecessary. The ethical question aside, the science strongly shows that adult stem cells can do any of the things that have been claimed by embryonic stem cells. So I believe we can push in that direction successfully and avoid the ethical quandary.

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The Chair: Thank you, Madam Picard.

Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): Thank you very much for the presentation. I want to focus on this whole question of implementation of a prohibition on human cloning. The draft bill we're dealing with actually calls for an outright prohibition on both therapeutic and reproductive cloning.

In your country, there are restrictions for companies who rely on federal funds—that's the way your president has tried to direct the research—but that doesn't stop private companies from doing the actual research. My first question is, would you like to see that kind of outright prohibition in your country as well, as you're advocating for us today?

Prof. David Prentice: Do you mean in terms of cloning?

Ms. Judy Wasylycia-Leis: Yes.

Prof David Prentice: Yes, I would like to see a total ban, and I've actually worked with Senator Sam Brownback and Congressman Dave Weldon in terms of formulating the bill.

The Weldon-Brownback total prohibition on human cloning did pass our House of Representatives this summer, on July 31. Interestingly enough, it passed by a large margin, over 100 votes. It has been blocked so far in the Senate, and other events, such as the tragedy of September 11, have certainly put it into the background. But with the recent events it has come back to the fore.

Senator Brownback, yesterday on the Senate floor, called for passage of the bill. President Bush has called for passage of the bill through the Senate and strongly supports a total ban. It's unsure whether or not it will move on through the Senate at this point in time. There has been a promise that the bill will be debated and voted on this coming March or April, but due to the recent events there's a very strong push to bring the bill up for a vote on the Senate floor within the next one or two weeks.

I might also point out that I spent last week in Europe talking with the British Parliament and the European Parliament. The European Parliament has also come up with and approved a report that calls for a total ban on human cloning, no matter what the purpose is.

Ms. Judy Wasylycia-Leis: What do you think the odds are of your country adopting a total prohibition or ban? I ask it simply because, given the dominance of the United States in the field, it's not going to make.... I mean, it's going to make some difference for Canada to move in that regard, but we're still going to be overwhelmed by the kind of research that's happening now in private corporations, and we're still going to be faced with considerable pressure for this country to approve requests for patents and to endorse research in this whole area. I'm wondering how we can maybe deal with that and work together vis-à-vis a general prohibition, and dealing with this globally as well.

Prof. David Prentice: I think there's at least a 50-50 chance of getting the bill passed through the Senate in the next couple of weeks. It might be pushed off to March or April, but I think that by that point in time there is an even stronger chance that such a total ban on human cloning will pass the U.S. Congress. As I mentioned, President Bush has already called for passage of a total ban.

I might point out, too, that in Great Britain, where they have wrestled with this problem of the so-called therapeutic cloning versus reproductive cloning, they have found out within the last two weeks, through a lawsuit, that their current laws do not even cover human cloning, and they're trying to rush through a very simple ban, a one-line bill, that I've seen in discussions with Lord Alton that would only outlaw implantation of a clone embryo into a woman.

I've already heard from the lawyer who brought the initial lawsuit that this particular bill has numerous legal loopholes in it. It looks as if effectively being able to stop one type of cloning versus the other is impossible. We faced that same discussion of only outlawing reproductive cloning versus all human cloning in our own Congress this past summer. The competing bill would have only outlawed the reproductive cloning.

• 1625

In point of fact, once the clone is made, there would essentially be nothing to stop an unscrupulous scientist from implanting that into a woman. So the effective point to stop human cloning is initially. In fact, if those cloned embryos were placed into a freezer alongside in vitro fertilized embryos, and someone were to pull out a vial of embryos and ask which are they, you couldn't tell the difference.

Ms. Judy Wasylycia-Leis: Is there a possibility that if we do move towards an outright prohibition on human cloning, we might just see pressure at the other end, with private fertility clinics encouraging the overproduction of human eggs to produce embryos for research purposes—getting at it in a roundabout way?

Prof. David Prentice: I suppose that's a possibility. The idea of human cloning actually bears on that same point, because it does require a huge number of human oocytes, of human eggs. In fact, the James Thompson I quoted, who originated human embryonic stem cells, has said this probably will not be a likely use of stem cells or source of stem cells in terms of cloned embryos because of all the problems, including the lack of eggs.

The other problem of creating embryos the old-fashioned way, you might say, rather than by cloning but by in vitro fertilization.... Again, one of my recommendations was that human embryos not be produced solely for research purposes. The European Parliament has passed wording to that effect. In our own Congress, I know Senator Brownback will be introducing a bill this spring to block that. There was outrage this past summer when the Jones Institute reported that they had done that.

You again face the problem, frankly, from a woman's health issue, of having to stimulate women with these huge doses of hormones to get the eggs, perhaps under the guise of making embryos for implantation, for IVF. I think we should go in the direction of not overproducing embryos for whatever purpose. In fact, there are good results now that you can freeze the eggs, rather than having to make the embryos and then freeze the embryos. That would seem a more logical way to go, rather than stockpiling embryos in the freezer.

Ms. Judy Wasylycia-Leis: Can I have one more quick question?

The Chair: Ms. Wasylycia-Leis, you're almost three minutes over. We'll move to Ms. Sgro, please.

Ms. Judy Sgro (York West, Lib.): Thank you. It's interesting to be the fifth speaker. I've had, right from the beginning, so many questions that were all very much on the same concerns and themes as others on this committee.

Mr. Prentice, you're raising some interesting issues. If we could just listen to you, then life could be much easier. It would help us make our decisions, and we could move forward on some of these difficult things. But there's always the next person who will come in and speak to us after you, who will insist that with regard to the adult stem cells issue it's too early. They will say that it's much better to do the embryonic cells and that we should be doing this rather than that.

You make it sound fine that we should just go with some of my instincts and ban the issue of embryonic stem cell research, and perhaps not deal with that for another five years and do this. But there doesn't seem to be as much confidence in adult stem cells from other people we have had before us.

How long has the research been going on in the adult stem cells to the extent that it gives you the kind of confidence levels you speak of today?

Prof. David Prentice: I think it's an interesting parallel when we compare these timeframes. The human embryonic stem cells were derived in 1998, but mouse embryonic stem cells have been used since 1981. So we've had those for 20 years. Some at least of the bone marrow stem cell work derives from bone marrow transplants, which we have done clinically for at least 20 years. But the interesting things in terms of changing from tissue to tissue also have been pretty much within the last two to three years.

• 1630

Now I realize you are in a position—all of you—where you continually hear competing claims and so on. What I'd suggest is that you ask those people who say adult stem cells cannot perform these various transformations or that embryonic stem cells can, to provide you the written evidence in terms of the weight of the scientific evidence. I would not ask you to try to translate all of the scientific jargon, but I would ask you to look through, when you have it available, the materials I've given you. It's not a complete list by any means, but I have tried, especially in a number of cases, to also give you the lay interpretation of what all of those scientific terms mean.

In point of fact, hardly a week goes by when there's not some new discovery, if not several new discoveries, reported for stem cells. By the same token, the vast majority of those have to do with adult stem cells. There are extremely few published successes for the embryonic stem cells. Perhaps it might be instructive simply to ask those proponents to provide even just a list of references similar to what I've given you as far as their successes.

Ms. Judy Sgro: If you go on to that, you're saying the adult stem cells have been around since 1981, and there hasn't been any huge.... We're really just hearing about things now in the last few years. So I am sure their arguments are that they can do far more with the embryonic stem cells than they can with the adult stem cells, because otherwise the adult stem cells would have been already way advanced than what they currently are today.

Prof. David Prentice: The mouse embryonic has been around since 1981, and we've been using bone marrow to do straight bone marrow transplants since about that same time.

The first number of references in the clinical list that I gave you devolve specifically from that, essentially repairing or replacing blood-forming tissues—so for anemias. With regard to the cancer treatments, you remove the patient's bone marrow stem cells, give them high-dose chemotherapy or radiation to destroy wherever the tumour is, and give them back their own bone marrow.

But the interesting results.... For 100 years we thought you started with as many brain cells as you're ever going to have and it's downhill from there. I'm on a college campus, and on a good Saturday night it's downhill faster for some of the students. It has simply been within the last three years that people have realized there are neural stem cells within the brain, and then it's like a series of dominoes. We found not only could those cells grow, but they could make more nerves. Then we found that they could also make other tissues such as bone and muscle.

It is a new area—I will not disclaim that—as is human embryonic stem cell research or even primate embryonic stem cell research. But I think the successes that have been seen overwhelmingly show what has overturned 100 years of dogma in terms of embryology—that we do have cells within our bodies that can do these various things that have only been claimed so far primarily for the embryonic.

The other aspect you might also consider beyond the adult stem cells and with the embryonic is, as I point out, James Thompson, prior to deriving human embryonic stem cells, derived primate embryonic stem cells. If we're looking to see whether the claims can be met in the dish or in the animal before we move to patients, I think it would behoove us to verify those claims in the animal models before moving to use of human embryos.

Ms. Judy Sgro: Okay, thank you.

The Chair: Madame Thibeault.

Ms. Yolande Thibeault (Saint-Lambert, Lib.): Thank you very much, Madam Chair.

I have just a very short question. Over the many interviews we've heard, scientists at one point have suggested that adult stem cells could possibly reproduce the same mistake if used rather than embryonic stem cells. Could you comment on that for me?

Prof. David Prentice: Yes, and that's a very important point in terms of this, especially if we are going to be giving the patient back their own stem cells to avoid the immune rejection.

• 1635

There are two pieces of evidence that this may not be a problem. The first one comes from this genetic experiment that I mentioned before in which the defect now was altered through replacing the defective gene in these infants who had the immunodeficiency. So one possible route could be doing the genetic engineering on the stem cells so that you do repair the defect and don't give it back to the individual.

But there have also been two or three interesting reports where individuals with diseases such as systemic lupus, which actually derives from a genetic defect within the individual as well.... And interestingly enough, what these researchers did was to remove the bone marrow stem cells and grow them in culture for a period of time and then give them back to the patients, but now without making any genetic changes. What they found was—and at this point it's largely unexplained—is that those cells seemed rejuvenated and did not carry back the defect, and in fact started to repair the damage. More study needs to be done on that in terms of whether it's a permanent change or not. It's been only about a year and a half to two years since those experiments.

At this point in time, the individuals still seem to be showing benefits and have not regressed back to the previous instance. But it's obviously an area that does need to be investigated. Perhaps in those instances we won't be able, in terms of a permanent treatment, to use the individual's own stem cells and we'll have to go to some of these matches from something like umbilical cord blood stem cells.

Ms. Yolande Thibeault: Thank you very much.

The Chair: Dr. Lunney.

Mr. James Lunney: Thank you, Madam Chair.

One of the items you mentioned was the creation of chimeras. Here we're dealing with assisted human reproductive technology and now we're talking about animal-human hybrids, and we might wonder how this gets messed into this topic, but here it is. In this release yesterday from Advanced Cell Technology, one of the principals, Dr. Jose Cibelli, admitted to fusing his own eggs with a cow egg, as you referred to.

Maybe you can help us with this. Presumably he took one of his somatic cells and transmitted the nuclear material into the cow egg. I presume that's what he did?

Prof. David Prentice: It was actually Dr. Cibelli and not Dr. West. Yes, he took a skin cell from himself and transplanted that into the cow egg. The press reports and some of the interviews that Dr. Cibelli has given indicated that they did get early embryos formed, so it got beyond the first few cells. Presumably he destroyed the embryos after that point, or else they didn't survive.

The interesting part here is it's not like this particular clone would decide that they need to go graze on the front lawn, but it is a question of what types of genes might you now be entering into the human germ line that would be passed on to future generations. In this particular instance, those genes will come from not the nuclear material that has been made, but from what are called the mitochondria, little energy generators within our cells. In humans there are only 13 genes that actually reside in those little energy-generating mitochondria. But we're not certain how the interplay takes place between those little 13 genes and the nuclear genome. In fact, those little mitochondria, some of their proteins, actually have to be coded for by the nuclear genome. We're not sure if there's an exchange back in the other direction.

I think the open question then should give us pause as to the mixing now of animal genetics with human genetics. Down the road probably the bigger question would be adding another type of animal or other non-human gene to the human genome and what effects that might have eventually in the future of humanity.

Mr. James Lunney: With the richness of the human genome and the expression of it we have with six billion of us running around the planet, why would scientists want to take genetic material from an animal and put it into a human? Can you speculate on that for us?

• 1640

Prof. David Prentice: One possible reason would simply be the “gee whiz, can I do it” scenario. All we scientists are curious, and it's a point at which you say that's a question I'm just not going to go ahead and try to answer.

You could speculate, though, that if we can't isolate a human gene for a particular disease, until we could, a stop-gap would be to take the animal gene and put it in. What would seem in some sense more of a science fiction scenario, though it's not, given the current situation, would be to add additional function to the human genome.

We currently have to have in our diet a certain number of essential amino acids to make protein. But what if you could make your own? What if you could make your own antibiotics? Again, we know so little about how the genes we have interact with each other to give normal functioning that I think it's presumptuous of us to say that we could then add additional genes to that genome and not have to worry about the eventual outcomes.

Mr. James Lunney: Thank you.

The Chair: Thank you, Dr. Lunney. Thank you very much, Dr. Prentice.

The clerk is trying to prepare that extra material for us, but the problem is that the translation of highly technical language and bibliographic references, etc., takes a very long time.

I'm wondering how Madame Picard might feel about receiving this particular highly scientific information in English, or would it be too difficult, because we might have to wait quite a while to see it if we have it translated?

We could have it translated and distributed to you later in French, but do we have your permission to distribute it in English for now?

[Translation]

Ms. Pauline Picard: Yes, you have my permission.

[English]

The Chair: We'll make sure you have an English copy with everyone else.

[Translation]

Ms. Pauline Picard: Thank you, Madam Chair.

[English]

The Chair: Thank you very much.

Thank you, Dr. Prentice. It was most interesting. Some of the committee members may want to speak with you a little bit now, but I have to suspend this meeting because we have to let the technicians in to get ready for our teleconferencing.

Prof. David Prentice: Thank you very much.

The Chair: I'll now suspend this meeting.

• 1643

• 1804

The Chair: This sitting of the health committee has now resumed. We want to welcome Dr. Eric Meslin, who is the director of the Centre for Bioethics at Indiana University. Welcome, Dr. Meslin. Thank you for waiting for us. I'm sorry we are late; we were delayed by a vote. Now, without further ado, the floor is yours, and you may make your presentation. After that, we'll ask questions, if you don't mind.

• 1805

Please go ahead.

Dr. Eric M. Meslin (Director, Indiana University Centre for Bioethics): Thank you very much, Madam Chair. Good evening.

First let me apologize for being unavailable to testify on a previous occasion. I want to express my gratitude to the committee and staff for making available this opportunity to appear before you using this teleconference technology. Let me also say what an honour it is as a Canadian to testify before this committee on a matter of both national and international importance, specifically the use of embryonic cells in research.

My name is Eric Meslin. I'm the director of the Indiana University Centre for Bioethics, assistant dean for bioethics, and professor of medicine and of philosophy. Prior to my arrival at Indiana University, I was executive director of the U.S. National Bioethics Advisory Commission. Many of my remarks this evening have been informed by the deliberations of that commission.

NBAC was established by President Clinton in 1995 to advise the White House on a number of matters of bioethics policy. Although we prepared a number of reports, it's my intention to provide a brief overview of only one of them, “Ethical Issues in Human Stem Cell Research”, executive summaries of which I believe have been made available to the committee. It's my hope that the experience of NBAC will assist your committee in your deliberations.

Following the announcements in 1998 that both human embryonic stem cells and embryonic germ cells had been isolated by two U.S. research teams, President Clinton asked NBAC to conduct a “thorough review of the issues associated with such human stem cell research, balancing all ethical and medical considerations”. We carried out our work on behalf of the President and submitted our report to the White House in September of 1999.

Our goal was to develop a set of recommendations that would provide guidance on the appropriateness of permitting the U.S. federal government to fund human embryonic stem cell research and on what constraints, if any, should be placed on this support. We approached this task with an important principle in mind, namely, if it is possible to achieve essentially the same legitimate public goals with a policy that does not offend some citizens' sincere moral sensibilities, it would be better to do so. This proved to be a daunting challenge.

As a federal advisory committee, we conducted all of our meetings in the sunshine, where the greatest possible scrutiny of our deliberations could occur. We sought input from scientists, ethicists, religious scholars, lawyers, government officials, and the public. I'm especially pleased to note that NBAC was aided in its deliberations by testimony from prominent Canadian academics and scientists and the prior scholarship of the Royal Commission on New Reproductive Technologies.

Now let me turn to some of NBAC's positions on these issues, particularly those arising from the several sources of these cells.

NBAC focused on three sources of embryonic cells: embryonic stem cells, or ES cells, from blastocysts or embryos remaining after infertility treatments; embryonic germ cells obtained from cadaveric fetal tissue following elective abortion; and ES cells from embryos that were created by somatic cell nuclear transfer cloning.

These sources were the subject of our analysis because at that time, late in 1998 and early in 1999, they were the only published methods for isolating and culturing human ES and EG cells.

Now, as to the first source, among the most controversial sources of embryonic cells are embryos remaining after infertility treatments that would otherwise be discarded. U.S. law provides a background for this discussion, since it prohibits the creation or destruction of a human embryo for research purposes. A 1999 legal opinion by the Department of Health and Human Services found that since a stem cell was not an embryo, federal funds could be used to support research that uses these cells, but federal funds could not be used to support research that destroys the embryo or creates research embryos.

• 1810

You have a number of figures before you that I think will be useful as I make my way through these descriptions. I'm referring now to what I call figure 2-3, the title of which says “Isolation and Culture of Human ES Cells from Blastocysts”.

Of the several ethical issues NBAC discussed about this source, two were especially noteworthy. The first is the moral status of the embryo. NBAC recognized that there is a plurality of views on this issue, from those who believe that the human embryo is but a clump of cells without any special rights or entitlements, to those who believe that the human embryo is entitled to the respect in law and ethics accorded to any living human person.

NBAC adopted neither of these extreme views, but rather adopted a developmental approach encouraging respect for the embryo as a form of human life, one that was neither absent any moral status nor deserving of full respect. Note that this approach does not require settling once and for all whether the embryo is a person, but it does require that cells must be obtained in a fashion that recognizes their humanity. This view would prevent, for example, the callous disregard or treatment or manipulation of the embryo or the cells obtained from it.

The second issue focused on the difference between the actual obtaining—or “deriving”—of the cells and the research use of those cells. While the 1999 opinion of the general counsel of Health and Human Services was that the federal prohibition on embryo research would not be violated if funds were used to support the use of cells—remember that these cells are not an embryo according to that definition—this opinion also reaffirms that federal funds could not be used to create or derive these cells, which would involve embryo destruction. NBAC's own legal analysis, which is available in an extensive appendix and which I believe I provided to the clerk of the committee, came to substantially the same conclusion, legally.

We focused not so much on the law but rather on the ethical issue of whether one ought to distinguish for purposes of public policy between funding the derivation—the destruction of the embryo—and funding only the use of the cells. Clearly, the procedures are separate and therefore distinct enough to warrant a different moral assessment. For example, derivation raises a number of ethical concerns, including whether the embryos were or were not in excess of clinical needs; whether there was adequate consent from the donor; and, most importantly, whether it is ever acceptable to intentionally destroy life, irrespective of the potential benefits.

The use of ES cells on the other hand tends to raise less profound ethical concerns once the cells exist in a cell line and are available in a laboratory, in a Petri dish or on a paraffin wax block.

While it would certainly be simpler as a matter of public policy to permit use and prohibit derivation—the position, by the way, taken by the National Institutes of Health in their draft December 2000 guidelines and later echoed in President Bush's August 9, 2001, policy—this position has a number of limitations.

• 1815

First, NBAC believed it was important for public policy to be both clear and ethically consistent. In the words of one of our commissioners, funding use, but not derivation, would be ethically disingenuous. It would amount to pretending you did not know the source of the cells you were going to use.

Second, funding derivation enhances scientific progress toward the health benefits that everyone recognizes are at the end of this scientific procedure. The synergy from a combined federal effort from research involving both derivation and use would be lost, and arguably would take that much longer to complete were use and derivation separately funded.

Finally, since recipients of federal funds are required to comply with federal research regulations, funding both derivation and use would mean that public and private sponsors would be subject to federal oversight and accountability. For these reasons, NBAC recommended that research involving both derivation and use of ES cells from embryos remaining after infertility treatments should be eligible for federal funding.

The second source is germ cells obtained from cadaveric fetal tissue following elective abortion. Interestingly, U.S. federal regulations do permit, under limited circumstances, the use of fetal tissue for transplantation research. Again, to refer you to one of the figures I have submitted, this would be figure 2-1, the title of which is “Isolation and Culture of Human ES Cells from Embryonic/Fetal Tissue”.

Federal regulations do permit limited use of fetal tissue in research, but it always remains somewhat unclear whether the intention of those regulations had contemplated the use of cadaveric fetal tissue in stem cell research. It had been contemplated for direct transplantation—for example, into the brains of Parkinson's patients—but never in this area.

As one would expect, we found that this source of cells raised important issues for those who had settled beliefs about their opposition to abortion, even though abortion is legal in the United States and federal regulations exist. In particular, for some people, the issue of association or complicity with an act that they regard as inherently evil or immoral cannot justify any potential health good that may result. For others, this issue is somewhat less problematic, and for still others, it's entirely a non-issue. To some extent—and in my view, for the wrong reasons—many equate the ethics of stem cell research with the ethics of abortion. As I noted earlier, ES cells from embryos remaining after infertility treatments do not involve the abortion procedure.

The commission also considered the issue of informed consent, recognizing that just as a woman's decision to terminate a pregnancy requires information and careful consideration, obtaining consent to donate fetal tissue is an ethical prerequisite for using such tissue to derive EG cells. Concerns regarding the coercion of women, or of commercializing this process, led NBAC to make a number of recommendations, including that embryonic cells cannot be bought or sold, and that consent for abortion must be separate, both temporally—that is to say, in time—and in the form it takes, from consent for the donation of tissue. In view of these issues, we recommended that research involving the derivation and use of these cells should continue to be eligible for federal funding and that various modifications be made to existing regulation so that there would be no confusion in that regard.

The final source of embryonic cells, those created by either in vitro fertilization or somatic cell nuclear transfer, differs from those following infertility treatment only in the intention of the researchers and the clinicians who obtain them. Here I'm referring to figure 2-4, “Isolation and Culture of Human ES Cells from SCNT”, or somatic cell nuclear transfer. These embryos and the ES cells derived from them have the advantage scientifically of being designed for particular purposes and roles, as well as having the advantage of being genetically related to the potential recipients of therapeutic transplants.

• 1820

In any IVF clinic, certain numbers of embryos are extracted, fertilized, frozen, used, transferred, donated, or discarded. U.S. federal law prohibits the creation or destruction of a human embryo for research purposes, so it is a matter of local procedure and protocol as to whether in vitro fertilization clinics in the U.S. extract and fertilize one, two, three, five, or even ten eggs at any one time. What may be one clinic's excess embryos may be another clinic's intentionally created research embryos.

We argued that only those embryos that were no longer to be used in infertility treatments, and would otherwise be discarded by the couple, should be used to derive ES cells. But those same clinics and other research groups not treating infertility could make embryos solely for research purposes, either by IVF or through somatic cell nuclear transfer cloning, and would not, in the United States, be violating any federal law or regulation, so long as the institution in which the activity was carried out did not receive federal funding.

The recent announcement by Advanced Cell Technology—the Massachusetts company that made its name, not only on this weekend but almost three years ago to the day, when they made another announcement about a cow and egg fusion experiment—presents ample justification, in my view, for a more comprehensive approach to regulation and oversight of this topic. ACT violated no federal rules or regulations in the United States in carrying out this so-called study.

I appreciate that legislating the intention of an investigator or a scientist or a clinician is a very difficult thing to do. In the case of ES cell research, there is a morally relevant difference between the intention to create a child and make use of embryos no longer needed to achieve that goal and the intention to create an embryo solely for research purposes.

At the time of our report, the combination of a sufficient supply of existing embryos, rumoured to be anywhere from 50,000 to 100,000, and a decided lack of social consensus supporting embryo creation led us to recommend that research with ES cells derived from embryos solely for research, either by IVF or cloning, should not be eligible for federal funding. I see no reason, three years later, to revise or amend this recommendation.

I want to close with an observation that I think is pertinent to your committee's hearing, and that is the importance of shared views on this topic. We recognize that people develop their moral perspectives and seek guidance on moral matters from a variety of sources, secular and non-secular. We sought input from many of these sources as well. Indeed, the U.S. Congress and the staff of the Congress—I know your staff will appreciate this anecdote—reminded us of how important it was to demonstrate that you have gone out of your way to seek the views of a diverse group before settling on your final position.

To more fully understand the ethical issues, we devoted an entire day of testimony to religious perspectives. Eleven scholars representing five different faith traditions testified before our commission.

• 1825

Importantly, we sought input from different scholars from each tradition: three each from Roman Catholicism, Judaism, and Protestantism, and one each from the Eastern Orthodox Church and Islam.

We found areas of agreement and disagreement. On some points, we found as much diversity within certain faith traditions as we did across these traditions. For example, there was internal disagreement even within traditions about the moral status of the embryo, about whether the use of EG cells derived from aborted fetuses involved complicity with the perceived evil of abortion and whether stem cell research should ideally be federally funded.

In contrast, there was widespread agreement within and across these faith traditions that stem cell research is not inherently immoral and can contribute to the alleviation of human suffering; that if society chooses to fund the research it should do so under conditions of respect for the humanity of the embryo; that if society is to proceed in this direction there are several background conditions of distributive justice that must be in place; and that if private research is to proceed, it should be the subject of public scrutiny and oversight no different from that found in federally sponsored research.

The system of review and oversight we proposed was modelled on the current structure of governance of human subject research in the U.S., namely a combination of local review by institutional review boards—what we in Canada call research ethics boards—and by a national panel that we named the national stem cell oversight and review panel.

In many ways the views of the scholars we heard, secular and non-secular, reflected the thoughtful and reasoned diversity of views that one expects in any pluralistic society.

There have been several developments since NBAC's report. Other countries have discussed this issue and issued statements, policies, or guidelines, as have international organizations such as UNESCO, the Council of Europe, and the European Commission.

In the United States, Congress has held numerous hearings and policy guidelines have been developed by a great many groups. The House of Representatives has agreed to a bill that would prevent cloning research, and today there was a whirlwind of activity seeking the support of Senate action on this same bill. The Senate, however, at least up until 5 p.m., when I sat down here, had yet to act.

President Bush's August 9 policy statement and the current NIH guidelines that activate that policy permit limited embryonic stem cell research on stem cell lines already in existence. This policy, and the guidelines developed to implement it, have left unchanged the legal status of this issue in the United States.

In summary, the most important of the recommendations I propose to you today reflects the view that U.S. federal sponsorship of research involving stem cells should be limited in two ways: first, that research should involve only the use of cadaveric fetal tissue with appropriate informed consent or embryos remaining after infertility treatment; and second, that federal sponsorship must be contingent upon an open system of national oversight and review.

I thank you very much for your attention under these somewhat difficult technological conditions.

The Chair: Thank you very much, Dr. Meslin.

We'll begin with a representative of the official opposition, and that will be Mr. Merrifield.

Mr. Merrifield.

Mr. Rob Merrifield (Yellowhead, Canadian Alliance): I want to thank you for your words and for the opportunity to be able to dialogue this evening. I think you've wrestled with some of the same problems that we have as a committee.

I'm actually interested in a couple of things, but the moral status of the embryo is something we've had a difficult time getting the right language around. I'm sure it's something you've dealt with. Could you give us your best advice as to what language seemed to meet consensus in your group?

Dr. Eric Meslin: I appreciate the question very much, Mr. Merrifield.

• 1830

We struggled with this, and I think the evidence of the difficulty is in the extent of the struggle. We achieved what I would call a limited type of consensus around language. The language and the phrase we used was “respect for the humanity of the embryo”.

That seemed to us to capture two important points. The first was that we did not achieve a consensus that there was a single definition, either in science or in law, let alone in morality or religion or ethics, on the moral status of the embryo. We knew what the range of views was, but with an 18-member commission representing a diverse group of citizens, as I'm sure you can appreciate, that kind of consensus was difficult.

Recognizing that we would not achieve agreement on either full and complete moral and legal status identical to that of an adult person in law, or that it would be appropriate to in any way disregard the embryo and refer to it as some clump of cells, we adopted what I call a developmental approach, which simply meant that the more developed the organism, the entity, the embryo itself, the more humanity it is becoming.

We understood that the stem cell itself, which was the focus of our report and deliberation, was not an embryo. We had no difficulty appreciating that scientific distinction. As to whether the embryonic stem cell itself was deserving of this kind of developmental respect, we felt that the stem cell itself was of lesser moral status than the embryo.

Mr. Rob Merrifield: Okay. I'm interested in your final conclusions. You're suggesting there's no law right now for the cloning that had taken place—the therapeutic cloning reported just this last week. Is that right?

Dr. Eric Meslin: Yes, that's correct.

Mr. Rob Merrifield: If the bill that is before the Senate right now were passed, would it change that?

Dr. Eric Meslin: Yes, it would, in a couple of ways. It gives the Food and Drug Administration the ability to regulate that activity.

There has been some debate in the U.S. Congress as to whether the Food and Drug Administration has the legal authority to regulate human cloning. I confess I am not a lawyer or an expert in regulation, but essentially what it boils down to is the difficulty in putting embryonic stem cells or even an embryo into one of the categories that the FDA uses to regulate: a biologic, a drug, or a device. It almost sounds disrespectful to refer to the embryo or the stem cell as a biologic, or as a medicine, or as a device.

So the lawyers who debate these things have been trying to clarify that, and the House bill—and the Senate bill, if it comes up—would attempt to give the FDA that authority.

Mr. Rob Merrifield: So what you're saying is, under the present regulations, if I'm just trying to get it straight, your recommendation is that federal funding would not allow the destruction of an embryo.

Mr. Eric Meslin: That is correct.

Mr. Rob Merrifield: But it's the Food and Drug Administration, you called it—

Mr. Eric Meslin: Yes.

Mr. Rob Merrifield: —that would perhaps put some boundaries around the private use of the embryos.

Mr. Eric Meslin: Yes, that's correct. Our recommendations went a little bit further than I have mentioned in my remarks. We recommended that although those two sources I refer to—stem cells remaining after infertility treatments and those from the cadaveric tissue—should be eligible for funding, both public and private sources, were they to conduct that research, should be subject to federal review and oversight. We wanted both the private sector and publicly funded entities to put their research protocols before a national panel, the group we called the stem cell oversight panel.

• 1835

Mr. Rob Merrifield: So if that were to take place, then you would actually be abolishing the opportunity to kill an embryo.

Dr. Eric Meslin: I would bet that if the ACT experiment we heard about on the weekend went before the committee we were suggesting, not only would they reject the proposal as being possibly unethical and non-scientific, but it should never have come to that committee, because we did not recommend the creation of embryos as being permissible.

Mr. Rob Merrifield: Thank you very much.

Dr. Eric Meslin: So that study would not be able to be conducted.

Mr. Rob Merrifield: The other question I have—and I don't know what kind of discussion went on, but perhaps you can enlighten us—involves the idea of patent law with regard to this kind of research. Can you tell me what you came up with there?

Dr. Eric Meslin: We discussed the issue of patents, of genes and other products, in a separate report, not in this one—a report I can provide to the committee called “Research Involving Human Biological Materials”. That report specifically looked at genes, and gene products, and DNA, but excluded the discussion of the fetus or the embryo. We wanted to keep separate those two discussions. The only mention we make of the commercialization issue is in our recommendation that says one cannot buy or sell these products—embryos—in the marketplace. We did not touch directly on the patenting issue in this particular report.

The Chair: Okay, Mr. Merrifield. Mr. Lunney.

Mr. James Lunney: Thank you, Madam Chair.

Thank you, Dr. Meslin, for your presentation and your patience in waiting for us tonight.

Dr. Meslin, your NBAC reported in September 1999. Is that correct?

Dr. Eric Meslin: Yes, it is.

Mr. James Lunney: And you mentioned in your report that there have been a lot of interesting developments since then. Over the last year and a half, certainly, there have been tremendous breakthroughs in adult stem cell research, and I'm sure you've been following this with a lot of interest. We've heard testimony even today about the tremendous potential in adult stem cell research.

This, perhaps, is information that was not available to your committee. In view of the great potential we've seen from skin cells, which are as accessible as a hair follicle, having stem cells in them, or fat cells, or, as we've heard today, even circulating blood—that through agglutination and centrifuging they can isolate stem cells even from blood circulating in any human being—would you suggest we have information available today that adds a whole new dimension to the debate? And would you comment on that?

Dr. Eric Meslin: Certainly. I appreciate the question very much.

I do think you have more information before you than we did in November 1998 and during 1999. At that time, the use of adult stem cells, well known in theory and in terms of animal research, had not yet made the front pages of newspapers or the scientific literature.

It's hard to imagine what we might have said had we known then what we know now, but I can offer this comment. We recognized that in order for science to proceed, some very difficult choices of a priority nature must be made. I'm comfortable saying the commission would have said it's not whether it's adult versus embryo or versus fetal, but rather that there may be good reasons to fund both.

The argument in that direction would be that we don't know how good adult cells are because the science of adult cell differentiation or reprogramming is new. We don't know whether in a sense we can deprogram them and then reprogram them in a different direction.

• 1840

There are many things, about which your molecular geneticists and biologists will have informed you in their testimony, concerning the number of things that can occur.

I think, however, that the commission, having heard that argument, was mindful of the opportunity that could be taken to advance adult stem cell research, and mindful that it should be taken. We recommended that both sources of stem cells should be funded, not embryonic at the exclusion of adult and not adult at the exclusion of embryonic.

I think the difficult policy choice facing all of us is how good the cells have to be in order to produce the kind of potential therapeutic benefit we seek. Do they have to be perfect, or do they have to be merely good enough? That's why, in my opening remarks, I offered the principle that it might be best to try to achieve a policy goal that least offends moral sensibilities. At that time we felt the approach we were adopting, while we were sure it would offend some sensibilities, was the best way forward.

Mr. James Lunney: Thank you. I can certainly see, given the information you would have had at that time, that your choices were made more difficult than what we face today.

We're hearing testimony, even today, about adult stem cells from two centres, from Germany and France, being used to repair damage after heart attacks. This is something that was only science fiction, really, when you were doing your work, and the language was that embryonic cells had all the potential, and adult cells simply couldn't be differentiated, and so on.

Leaving that for a moment—and thank you for your comments—and going back to the report from your Advanced Cell Technology in Massachusetts and to the issue of chimera, there is apparently no law against combining human and animal cells. I notice with some interest, and I might say personal alarm, that one of your scientists involved there, Dr. Jose Cibelli, admitted to fusing his own cells with a cow egg. Of course, it was deactivated after the 32-cell stage, but we might wonder at our end why we would want scientists to go in this direction. Do you have any comment on chimera and your debate about it, or did you discuss this?

Dr. Eric Meslin: I do. It is so unfortunate that we are here by teleconference, because I'm smiling, and I hope you will take it in the best possible way. The ACT folks were known to us in 1998. In fact, it was the cow-egg fusion experiment that was announced on the front page of The New York Times on November 11, 1998, that really was the straw that broke the camel's back for President Clinton asking NBAC to write the report.

That was the same week that Thomson and Geron reported their findings in the peer-reviewed literature. Then we heard through The New York Times that ACT had apparently created this chimeric organism, having never published their findings in the peer-reviewed literature—and to this day they have never provided that information.

We acted very quickly following that report. As you know from the materials I provided, a day later President Clinton wrote to NBAC and said, “I would like you to address this issue.” Four days after that we met in Miami, Florida. The CEO of Advanced Cell Technology, Mike West, came to our meeting and testified before our commission, and a day later we wrote back to the President. In our response to President Clinton—contained in the materials I provided to you—we argued quite quickly and quite persuasively, I believe, that that kind of study is unethical and should not be done, period.

The latest report from ACT is of the same genre. Scientifically, there is not much “there” there. To go to a sixth-stage level and not have anything happen is not even interesting scientifically. My own view, I think you can tell from my reaction, is that I find that kind of science to be not helpful to the discussion, and it could inadvertently focus our attention away from where it should be, which is on what the appropriate response by the government—the governments of the world, really—should be to this kind of high-quality stem cell research, and not these sorts of things.

• 1845

Mr. James Lunney: Thank you very much.

The Chair: Thank you, Dr. Lunney.

Dr. Dromisky.

Mr. Stan Dromisky (Thunder Bay—Atikokan, Lib.): Thank you very much, Doctor, for your very comprehensive report. It was truly enlightening.

I have a few questions. I'm concerned about the kind of regulatory body that we will establish here on this side of the border, both for private and public involvement in this area.

You indicated in your report that you have a national stem cell oversight and review panel. Could you give us some information on that? Who is on it? How are they chosen? What kind of powers do they have? Do they have any influence whatsoever? What will happen to this body once the bill is passed by the Senate, if the Senate bill is going to have any influence whatsoever?

Dr. Eric Meslin: I appreciate the question.

The status of that panel is that it does not exist. We recommended that the panel be established, and the White House did not accept that recommendation. What has happened is, following President Bush's policy statement of August 9, the National Institutes of Health did establish a group somewhat like what NBAC recommended, a group consisting of scientists and others. That group has the authority to review the research protocols brought before it for federal funding. It does not have the same scope that we had intended or hoped such a panel would have, the kind of public accountability—and I called it “sunshine”—for the public to be able to observe and obtain copies of these projects so that there would be greater accountability.

At this point, the NIH panel is a very important and useful panel to assess the protocols themselves, but not to have the kind of policy guidance that I think a national body ought to have.

I should say there's one other item that did not make its way into our final report, even though it had been discussed. This was a model that I think you are familiar with from the United Kingdom. We were encouraged to consider having a licensing body like the Human Fertilization and Embryology Authority in the United Kingdom that would grant licences to researchers and institutions that satisfied ethical and regulatory criteria. NBAC did not adopt that recommendation even though it was recommended, and I think—these are my speculations, not speaking on behalf of the commission—it was felt that it would appear to be adding another layer or level of bureaucracy to an oversight system that had not been proven effective.

My own personal view is that before disregarding or removing that possibility, care should be given—as I think in the bill before your committee, which I have been able to review briefly, some care has been given—to that approach in this bill that we did not adopt in our report.

Mr. Stan Dromisky: Thank you very much.

I perceive that you have a very complex system in your country. Right now we're talking about regulations, and so forth, on the federal level. But with all the states you have—and I'm aware of the fact that many of the states have a variety of rules and regulations pertaining to IVF—I wonder if your federal proposals are going to have any impact on the state regulations that are already in existence.

Dr. Eric Meslin: I think they will have an effect insofar as the sources of stem cells at this point that are available for federal sponsorship are controlled by the National Institutes of Health, a federal funding body. Where the issue becomes controversial is, unless and until the federal government decides to regulate all the IVF clinics in the U.S.—and there may be as many as 500, 600, or 700 of them; we don't know how many there are—there will always be the possibility that not only groups like ACT, who are legitimate research groups.... They are not strange cowboy organizations; they are legitimate research groups. But there will be cowboy groups at clinics who are not in any way interested in publishing their data in the newspaper or anywhere else and will be involving women—in a sense, unsuspectingly—in research by removing excess ova and fertilizing them and not telling them what's going to go on. So I think it will be important for the States to do this.

• 1850

In the state where I have been living for only four months, Indiana, there is proposed legislation federally in Congress that would ban cloning. It is very much like the House bill. The term “cloning” carries with it such dramatic feeling for many people that some feel it's best to ban everything that has the word “cloning” in it. I think that would be a mistake as well.

Mr. Stan Dromisky: Going back to the state level, is there any state—

The Chair: Mr. Dromisky, keep it a short one. We need to allow for another questioner.

Mr. Stan Dromisky: Is there any state that requires, through regulations, a licence in order to do stem cell research?

Dr. Eric Meslin: Not a licence in the way that we were discussing with the HFEA, but Geron Corporation, which holds the patent on many of the ES cell processes that Jamie Thomson produced, does have a very large and complex licensing arrangement for those private companies that wish to make use of those stem cells not going through the federal government sources. Wisconsin is the state where that is most well developed.

The Chair: We're beginning to run out of time, but Madame Picard has a couple of short questions. The next guest for teleconferencing is now waiting.

[Translation]

Ms. Pauline Picard: Good evening, Mr. Meslin. I have two questions. My first question is somewhat similar to Mr. Dromisky's statements and it is about the moral value of embryos. There is something I do not understand. Perhaps it is because I did not grasp your explanation.

It is becoming immoral to do research on embryo cells that is not financed by federal funds. On the other hand, there is another aspect to consider. You said that there are from 500 to 700 fertility clinics in the United States besides an unknown number of laboratories authorized to do research, which is perfectly moral because they are not funded by federal funds. There is something I do not understand about this system you have.

Here is my second question. What are the objectives of the National Stem Cell Oversight organization? To whom is this organization accountable? Is this organization accountable to the federal government?

[English]

Dr. Eric Meslin: Thank you very much for the question. Just to restate what the commission felt, we did not believe you should distinguish between public and private sponsorship of research. We felt that research involving human embryonic stem cells, whether by the public or private sector, should be eligible for federal funding under certain limited conditions. The first condition is that the sources can only be embryos in excess of clinical need for which consent to discard them has been provided from the fetal tissue source. The second condition is that these studies would be subject to national oversight and scrutiny.

• 1855

I have to acknowledge and admit to you that because NBAC did not believe federal funds should be used to create these embryos, the door was left open for others to do this. That was one of the consequences of 18 members of a commission trying to reach agreement. We understood and accepted that one of the consequences of our recommendations was that private research would still go on in areas that we felt were ethically unacceptable.

With respect to the national oversight panel, I would just repeat the answer I gave a little earlier. We had hoped that such a panel would be adopted and accepted by the White House, but it was not. The current panel that NIH uses reports through the NIH system.

Mrs. Pauline Picard: Merci.

The Chair: I do want to squeeze one question in. You said there was a consensus across faith traditions that stem cell research was not inherently evil. I'm assuming you mean stem cells from all sources. Was there the same consensus across faith traditions on research on stem cells derived from embryos? This is the main question we're facing.

Dr. Eric Meslin: The agreement, which I would call a thin agreement, was that these enlightened individuals fully recognized the potential health benefit that could come from this very exciting scientific discovery. They were not naïve to the possibility that diabetes as we know it could be eliminated by creating cells that would eliminate the need for insulin. They were fully aware of the scientific progress and the health benefits that would be derived from this.

That's where the agreement ended. They did not consider, in other words, that this kind of research was immoral and should never be done. They recognized that it had great value. Where they differed was at the level of sources and at the level of government oversight.

The Chair: In fairness, it would be very easy, in my view, to get agreement from almost any group of people that the potential of research on stem cells was very good, particularly if it was adult stem cells you could get from skin or hair. The whole tough question is the other one, which is the use of the embryo as a source and therefore its destruction. That's the one we're wrestling with.

Dr. Eric Meslin: I couldn't agree with you more. I know our time is short. I'll simply summarize.

We were not seeking the advice of the 11 scholars. We were trying to understand what the spectrum of understanding was across and within faith traditions. We gave them as much credence as we did our scientists, ethicists, and lawyers. It was simply an important reminder that the diversity that existed was both within and across traditions. We had people who were Roman Catholic or Jewish disagreeing with one another. That's where we went.

The Chair: I want to thank you very much, Dr. Meslin, for joining us. Hopefully you felt a connection with your roots in dealing with a group of Canadians like this. We wish you well in your work.

Dr. Eric Meslin: Thank you very much. It was a pleasure.

The Chair: We will pause briefly.

• 1859

• 1905

The Chair: We'll now resume this session. Our guest is Professor Ken Daniels, who is an associate professor in the Department of Social Work at the University of Canterbury in New Zealand.

Welcome, Dr. Daniels.

We're hoping that you will have a statement for us, which we will listen carefully to, and then we will respond with questions to you. Is that agreeable?

Professor Ken Daniels (Associate Professor, Department of Social Work, University of Canterbury, New Zealand): Yes, I agree. You have received my written submission, have you?

The Chair: I believe so. Unfortunately, Professor Daniels, we always have to have everything translated into French. I don't think it's back from translation yet, but we will be getting copies.

Prof. Ken Daniels: Would you like me to read or summarize?

The Chair: Summarize it, I think, and our questions will probably probe into those areas you might want to give us further explanation on.

So, please, the floor is yours.

Prof. Ken Daniels: Thank you very much, and I must say that it's an honour to appear before you on what I regard as an extremely important topic. I think the plans you have for legislation and regulation are extremely exciting.

In the submission I made to you I expressed some concerns and then went on to talk about privacy and access to information. Then I put forward some responses to the kinds of arguments you will probably be hearing in relation to this whole issue. I concluded with some comments about the need for education, and in many ways that's the area we will probably end up talking about the most.

My statement of concern is really about the fact that in the preamble to your legislation you make it very clear that the welfare and the interests of children are very important. My reading of the details of your legislation suggests to me that you haven't accorded that high priority further down. In other words, the detail is in contradiction with the principles, and I point that out in the fifth part.

The Chair: If I may comment just quickly, the committee felt exactly the same way about the draft legislation, and we are doing our best to reverse it so the rights and interests of the child come first and everything else flows from that. So you'll be relieved to hear that.

Prof. Ken Daniels: I'm very clear now. However, I do make the point that while I think there has been a tendency to focus on the welfare of the child, we also need to think about the welfare of the family. It's not just a child, it's a child within that family context.

I want to talk about the whole issue of privacy and access to information, and to express my concern, if you like, about the way secrecy has tended to operate in this whole area of assisted human reproduction and particularly in the area of third-party reproduction. I illustrate that with the first case of donor insemination reported in the world, where the doctors actually carried out the insemination without the permission of the couple, and following that the doctor decided to tell the husband. The husband was very concerned; on the other hand, he said, this is fine as long as you don't tell my wife. So secrecy started and has continued.

• 1910

What I want to suggest to you is that professionals have played a very significant part in the development of that whole culture in relation to third-party reproduction. Because of that, there is a need to reassess where we are heading and the impact of that especially on children and families.

Briefly, I suggest to you in my submission that there are three areas that you are likely to receive submissions on that will challenge the kind of position that I'm advocating, for example. Those three positions relate, first of all, to the fact that if you move to an open system, you'll not be able to recruit donors. I've proved from the research I've done in several countries around the world that this is not the case.

Certainly it is more difficult to recruit donors, but if we take a country like Sweden, which introduced legislation in 1985 to require that donors be identifiable in the future, in fact there was an immediate decline in the number of donors; it's gone back up and there are now more donors in Sweden than there were prior to the legislation. They are different kinds of donors. They tend to be more mature men who have had their families, rather than the younger students who previously were being recruited.

I point to several pieces of evidence, which are all in my submission, that show that this is a pattern in several kinds of countries. So I'm really trying to suggest that one of the anxieties about a fall-off in the supply of donors really is not appropriate when you look at the research.

The second point I make is that a lot of the proponents of secrecy argue that donors actually want privacy. They don't want to be identified. I actually quote from a number of studies, some of which I've been involved in, some of which have occurred in other countries, where for example 56% of men in one study supported the idea of a national register of names and addresses so that they could be contacted in the future. In another study, it was 60%, in another 59%, in another 68%, etc.

So there's quite a lot of evidence that donors are not necessarily wanting to say, “I supply my semen and that's the end of it, I don't want to have any further contact or involvement.” But it's an argument that's often put forward to support the idea of secrecy.

The third argument I talk about is that some of my colleagues would say that we have no evidence that secrecy is not a bad thing in families, and that in fact until we have specific evidence then we shouldn't actually change our policy. We are now starting to get some evidence coming forward. It's in dribs and drabs, if I can use that terminology, because of course the secrecy has meant that it has been very difficult for us to be able to access people to find out what is happening in families.

But what is clear is that when you have families who are appropriately prepared for donor insemination, and all of the issues about secrecy and anonymity are discussed fully, then in fact you get a very different kind of approach.

I want to specifically talk about a program that I've been involved in in Germany over the last two years, where with a colleague I have been running seminars for people who are about to start donor insemination programs. We've done a study and what we have found....

I don't know whether you realize, but I'm actually in Australia at the moment; I'm a New Zealander, of course, and I'm here because there's an international conference on.

We've presented a paper at this conference in which we have shown two things. First of all, when people come to these seminars, their confidence level in the use of DI is relatively low. At the seminars it goes up sharply, and after the seminars it increases even further. So they are more confident about using this treatment.

• 1915

The second significant thing is that as a result of these seminars, their decision whether to tell the children changes quite dramatically. Again, it starts from here, and after the seminars it goes up like this. What I think that means is that when you bring people together, when you present educational programs, and when you enable them to talk with each other and to find that there are other people who share the same views, their attitudes actually change. This is in many ways in sharp contrast to the advice they often receive from medical professionals. That kind of evidence is now very clearly on the table, as it were.

The other point I make in my submission is that there is a need for an educational approach to this whole area. I can best sum it up by saying that up until now, and in effect even still now, the predominant way of approaching this whole area is and has been to see it as an issue of treating infertility. If in fact you are treating infertility, then it's a medical issue; it's a health issue.

I and some of my colleagues have been arguing that, yes, it is about treating infertility, but it's also about building families. If you focus on the building of families, then a whole lot of non-medical issues start to emerge—the psychological, the social, and the ethical issues—and if you are looking at an infertility treatment model, you're just looking at the people sitting in front of you, usually an infertile couple. If you take a building-a-family model, then you have to think about what happens further down the track, and that means taking into account the children and the couples.

When I was in Canada—I don't know whether it was earlier this year or possibly last year—I spoke at one of the clinics. I actually gave the illustration of how, when you go into an infertility clinic, there is invariably a big board with all baby photos on it—you may have seen this—smiling babies, and it's all very lovely and very encouraging. In a sense this is the clinic's success; they have helped produce these babies.

I said to the clinic staff that I was seeing different pictures, that the pictures I was seeing were of families and adolescents. There were no pictures like that on their boards in the hospital, but I was seeing them metaphorically in terms of counselling and research.

These families were saying two things to me: first, we are very grateful for the help we have had from clinics in terms of enabling us to become a family. The second thing they were saying was, we wish you had done more to help prepare us for this kind of family building, because there are issues arising for us that we didn't think about and weren't really prepared for. Now, they're not being critical. They're saying, could you do some more? I think it's that whole area we need to think about if we're going to offer a comprehensive program.

That's a brief summary of my submission, and I hope that gives you an overview of some of the concerns I have.

The Chair: Thank you very much.

We'll proceed to the questioning portion. Our first questioner is the representative of the official opposition in our Parliament, Mr. Merrifield.

Mr. Rob Merrifield: Thank you.

I couldn't agree with you more when you talk about education and the need for more information in this area. One of the things we've wrestled with as a committee is this whole area of counselling prior to getting involved in this. I'm wondering, because I think we're going to do something in that line, where you're at. You say the seminars work well, but is that another form of counselling, or do you have counselling on top of that, and is it compulsory? Can you give us any information there?

Prof. Ken Daniels: There are different ways of organizing the systems, obviously, in different countries. In my own country of New Zealand, every clinic has to have a counsellor. They would not be accredited by the professional body if they did not have a counselling service. That same principle applies in Australia as well. I think that's quite fundamental, because it means the counselling service is seen as an integral part of the whole program.

• 1920

There's a secondary question that arises from that, though, and that is whether the counselling should be mandatory. Should everybody have to see a counsellor? There's divided opinion on that, but I think almost all counsellors in this part of the world would say that where you have third-party reproduction, where gametes from another person are involved, counselling should be mandatory.

One of the problems is the word “counselling”. When most people think of counselling, they think of it in a therapeutic or a pathological sense: you have a problem that you need to talk about and resolve. I think a much more helpful way of thinking about counselling is that it is an enabling process with a heavy educational component built within it, so that people are exploring what it is going to mean for them to use this kind of way of creating their family. You can never prepare people completely. There is always going to be a need for further intervention along the line.

So in answer to your question, yes, counselling should be in every clinic and, yes, I think it should be mandatory for those who are using third-party reproduction in particular. But the focus of counselling needs to be thought about pretty carefully.

The reason the seminars are being run in Germany, for example, is that none of the clinics in Germany have counsellors attached to them. In a sense, we're having to provide this in a different kind of way. I would hope, for example, that counsellors in clinics would be providing such seminars as part of a comprehensive range of counselling services.

Mr. Rob Merrifield: Thank you very much for that.

I'm really struck by the emphasis of the family. I think that's something our piece of legislation has failed to address appropriately. When it comes to the clinics and the fertilization and the couples who come to you, quite often I think we focus on the couple and their fertility rather than looking downstream farther and taking the best interests of the child.

Do you apply the same standards for adoption—because that's obviously in the best interests of a child—as you do with fertility? Would we fertilize single mothers without the appropriate resources to deal with them? Do we think that far down the line? Are you thinking about that in your country? Do you have any comments on that? Is that something you consider?

Prof. Ken Daniels: Yes. In relation to adoption, those services have been provided for years, on the basis that we have to think about the best interests of the child. One of the problems with that is how to actually combine the best interests of the child with the best interests of the birth mother and the birth father, if he is being identified, and the recipient couple. Getting all of those together is sometimes complicated. That's why counselling plays such a basic part in it.

In New Zealand, for example, we were one of the first countries in the world to move to an open adoption system. I think that has helped influence our approach to third-party reproduction. Why should third-party reproduction be any different from adoption? If in fact it is very similar in that respect of it—I appreciate that there are many differences—then you have to apply appropriate counselling provisions. So the answer is yes.

Mr. Rob Merrifield: I guess that leads to the other two questions. If you have a compulsory counsellor in every clinic, who pays? Who enforces? Can you dwell on those two?

• 1925

Prof. Ken Daniels: The question of payment is a tricky one. I would be the first to acknowledge that the kind of approach I'm promoting costs money. But I think it's a good investment because in the long term, and further down the track, there will be issues that arise that may well require much more extensive counselling and intervention if we don't take a preparatory approach.

You may be interested to know that in New Zealand, in one of our clinics that provides both private and public treatment, the fee that is paid includes one hour of counselling. So when you go in and write your cheque for whatever it is, you are entitled to at least one hour of counselling as part of that fee. It is very rare that somebody does not take that opportunity.

But I think there's another element to that, which is that the whole staff are committed to counselling. A couple may well see the doctor, for example, who says, “I have assessed you, and now of course you'll be seeing the counsellor to talk about some of the social and emotional issues that are associated.” So it's taken for granted. It's not like, “Well, perhaps you'd better go and see the counsellor now”, as if this is a second-rate kind of exercise. I think that's the ideal way of doing it.

There's no doubt that in terms of public systems, the cost of counselling will be a significant one. Just to employ another staff member is going to cost money, and I fear that in the private clinics, that means the patients are going to have to pay more. In the public system, I'm not quite sure how you manage that in Canada, but social work counselling services are provided for other patients in other parts of the hospital service, so why shouldn't they be provided in this?

Mr. Rob Merrifield: Which is the enforcement of that?

Prof. Ken Daniels: Again, in this part of the world, we have this professional body that comes to assist clinics, and they accredit clinics. If in fact counselling is not being provided, then they won't get their accreditation, which means they won't be able to get the patients.

Mr. Rob Merrifield: Thank you.

The Chair: Thank you very much, Mr. Merrifield.

Mr. Lunney, please, then Dr. Dromisky.

Mr. James Lunney: Thank you, Madam Chair, and thank you, Professor Daniels.

On the question of anonymity of donors, we kind of saw that our draft legislation was very much leaning towards privacy and control of information and so on, and was very much designed to protect the privacy of the people making these donations. Frankly, I think some of us weren't too impressed when we heard that our clinics were importing sperm from prisoners in the United States.

We've heard witnesses here who were some of the early ones who came into the world through this type of technology. They had made the effort to come here themselves to tell us about some of the problems that created for them in adolescence, with questions that perhaps some adopted children have about their origins. So we're quite interested in making sure the needs of the children are adequately protected. There seems to be a sentiment that way.

Can you tell us, first of all, how many clinics there are in New Zealand? When did you get legislation? Finally, can you come back to this question I just raised about information and how you ensure there is adequate information? Is there legislation to make sure there's information in an open system?

Prof. Ken Daniels: We have six clinics operating in New Zealand, and that's for a population of just under 4 million. So that's the first question.

In relation to the legislation, in 1987 we passed a critical piece of legislation. It was called the Status of Children Amendment Act. I personally think it was misnamed, because it wasn't about the status of children; it was about the status of parents. What it did was to clarify the rights and responsibilities of the donors and the social parents. It made very clear that there were no rights or no responsibilities between the donors and their offspring. In other words, no claim could ever be made against a donor.

• 1930

As I understand it, in Canada you have three provinces that have legislation like this in place at the moment. I think it's Yukon, Newfoundland, and Quebec. We could not be in the position that we are now without that enabling legislation. It really set the scene, as it were, in terms of identifying that there could be no claims, and it's fundamental to have legislation like that.

My knowledge of Canada would suggest to me that—and I'm sorry, I might be intruding in an area that I shouldn't be—it's a federal legislative area rather than a provincial one, because this is about having a standard legislation for the whole country. Forgive me if I've intruded in an area where perhaps it wasn't appropriate.

There was another part to your question and I didn't quite jot that down, which was....

Mr. James Lunney: It was the number of clinics. I think you're actually addressed it. I was concerned about how you made sure this openness was delivered and how you process information. When are children advised of that? And how are you handling it? Is that through legislation, or is it more something that's developed culturally?

Prof. Ken Daniels: It's very interesting because the piece of legislation I referred to, the 1987 one, is the only specific legislation we have in New Zealand at the moment. We have two bills that are before Parliament, and I'll come back to those in a moment, but the interesting thing is that none of our clinics in New Zealand will recruit donors who are not prepared to be identified in the future.

So we have actually achieved this position without legislation, and we are the only country in the world that has done this.

I can't help drawing a comparison between Sweden and New Zealand. Sweden was the first country to introduce legislation in 1985, and there the number of families who are actually being open is quite small. There's been a recent study that has reported on this. The reason they have had this difficulty in Sweden—and I've been doing work there so I know it quite well—is that the law was changed, but the attitudes weren't changed and the practice wasn't changed. So it's one thing to create a law; it's another thing to actually provide an environment in which the culture changes so that professional behaviour changes.

I think we have been very fortunate in New Zealand that we have been able to influence doctors in particular about the need for a family-building approach.

The reason why we have two pieces of legislation before us at present is not to try to bring about change, but to, as it were, codify the change, and in particular to establish registers as a central system, because at the moment the registers that are kept are kept within the clinics, and while this seems satisfactory at one level, there are a number of potential problems with it.

So there is total agreement in both of the bills, one of which is a private member's one and the other is a government bill, that there need to be registers established and there need to be regulations about access to those registers—for example, who, when, how, etc.

We've had a tricky situation in New Zealand because the private member's bill was presented three years ago and wanted to argue for a similar system to the United Kingdom's, with a comprehensive council and regulations. Many New Zealanders felt this was too comprehensive for a country our size, with six clinics and four million people. So the government introduced an alternative proposal in which they argued that the existing ethics committee, of which I'm a member, should take on some policy functions as well as the ethics.

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What has happened is that there was a select committee to consider these two bills, and the process now is that it has been referred back to officials for some merging of the bills. We're expecting something to be reported back, and it will then go through a select committee process again. So we're moving towards legislation, but I don't think it will be a heavily enforced legislation.

Mr. James Lunney: So the primary purpose of the legislation is to establish registers?

Prof. Ken Daniels: That's a major part of it. There will also be some clauses I think to prevent certain practices, and herein we're obviously talking about cloning. Just as your royal commission suggested that there were certain things that should be prohibited, almost certainly there will be some of those in that bill.

The Chair: Thank you, Mr. Lunney. We'll now move on to Dr. Dromisky.

Mr. Stan Dromisky: Thank you very much. Thank you very much for joining us from way down yonder. I would like to hear what your government has done in the whole area of surrogacy, surrogate mothers and so forth, what regulations exist, prohibitions, and so forth.

Prof. Ken Daniels: Because there is no legislation in place, surrogacy has fallen into the arena of ethics rather than regulation, and the committee that I'm a member of decided, first of all, that surrogacy should not be allowed, and recently has moved to change that position, focusing particularly on surrogacy that involves in vitro fertilization. In other words, the surrogacy that occurs between consenting adults and doesn't require medical intervention, we can't do anything about, and we've had several examples of that occur in New Zealand. But in relation to couples who go to a clinic to seek surrogacy using IVF, we've set up some draft guidelines for clinics. Those clinics have to meet those draft guidelines, and counselling plays an absolutely crucial part for that. They then have to submit the application to the ethics committee, who will look at all of the documentation and decide whether in fact the surrogacy can proceed.

So that's the way it's being controlled at the moment. It may well be that with the new bill there will be some provisions for surrogacy to be legislated for. I think we have accepted surrogacy; it's a question of how do we manage this.

Mr. Stan Dromisky: Are there regulations regarding compensation for the surrogate mother?

Prof. Ken Daniels: Expenses only, so nobody can be paid to be a surrogate mother.

Mr. Stan Dromisky: That's what I wanted to know. Thank you very much.

The Chair: Thank you, Dr. Dromisky. We'll have Madame Picard now.

[Translation]

Ms. Pauline Picard: I did not have any questions Madam Chair.

[English]

The Chair: I'm sorry. Madame Thibeault.

Ms. Yolande Thibeault: Thank you very much, but I'm afraid Dr. Dromisky asked my question. This is an area we're all thinking very deeply about. It really bothers us, the whole concept of having possibly five people involved in the birth of a child. Outside of that, you were saying earlier that donors are still available whether they are paid or not. You were mentioning the fact that those donors, instead of being students, would probably be older men with families. What would be their motivation?

Prof. Ken Daniels: It depends which donors you're asking about as to what answers you get in terms of motivation. I have found, in the studies I have done in Sweden, Australia, New Zealand, and in England, that there is a pattern. For older men, with their families, it's much more altruism, if I can use that term; there is a concern to help other people. But for younger students, monetary issues seem to be quite dominant. It's not black and white. Obviously there are shades of grey within that.

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I think a lot of older men are actually saying they don't want the money, perhaps because the money is not important to them at that stage in their lives, whereas for younger students, money can be a significant incentive.

Ms. Yolande Thibeault: Thank you very much.

The Chair: Professor Daniels, I'm sort of surprised and a little bit disappointed that a ban on surrogacy is being lifted in your country. Did I understand that correctly?

Prof. Ken Daniels: Well, it's not so much a ban. There is no legal status for surrogacy at present. What we had was a decision by the ethics committee that it should not be allowed. Now we have moved to a position where it is allowed, but under very strict controls and management.

The Chair: The reason I'm surprised is that one of the parts of our study that we have found most disturbing and alarming, with several overtones, such as commercialization of everything.... We have a situation here where there have been certain surrogacy arrangements made under contract law, for example, that we find appalling. So we are considering banning it altogether and making anybody who encourages it even, or facilitates it, or does anything of that sort, to be outside the law.

The reason we're doing that is because of testimony we had from one witness, who was I think also in your field of social work, who said adoption is a situation where a child is in a difficult situation and four or five adults work together to put that child in a better situation, whereas surrogacy is a situation where there is no child and four or five adults get together to create a difficult situation for a child. Would you agree with that?

Prof. Ken Daniels: Yes. I don't think there is any doubt at all that surrogacy presents major issues. The Warnock committee in the U.K., when it looked at this whole area, said surrogacy was the most difficult topic it had to address, amongst all of the issues to do with assisted reproduction.

I have my own personal views about surrogacy, but I have to say that if one bans it, I think it goes underground. I have seen many situations in New Zealand and in Australia where it has been very successful and there seem to be no problems. I have also seen the ones that hit the media where there are lots of problems. For me it's a question of how we manage the area in such a way that vulnerable people are not made more vulnerable or damaged as a result of any intervention.

The notion of commercialization is not acceptable in New Zealand. There could be no payment. There could be no acceptance of agencies that facilitated surrogacy. We would just not accept that. But we do accept that where there is a medical condition—for example, a woman does not have a uterus—then there may well be a case for providing medical treatment to enable that woman and her partner to have a child.

The counselling aspect of it is just so crucial. For example, we say the commissioning couple has to be counselled by one counsellor, the surrogate and any family she has have to be counselled by another counsellor, and then they all have to come together with both counsellors for the issues to be fully discussed. It's only if the counsellors report to the ethics committee that they feel this is satisfactory and there are no major problems pending that it is allowed.

The Chair: Thank you very much.

Dr. Lunney, did you have another question?

Mr. James Lunney: Just a short one.

Thank you. That was very interesting. I have one final question on a similar subject, and that's payment for gametes.

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We've had outrageous amounts offered to fashion models here to donate, for designer family motives, we presume, some form of eugenics. How is that handled in New Zealand?

Prof. Ken Daniels: We have a general policy of anti-commercialization in the whole field of children. We don't allow any money to be paid for adoption, and, in a sense, we've transferred that policy over into the area of assisted human reproduction.

When I had some discussions with Health Canada officials a couple of years ago, we had an interesting debate about this. I think there is a place for expenses, but I'm a bit concerned that the expenses can end up being a cover for payment. In other words, you walk around the corner to the clinic to make your contribution and you still get paid $20 or $30, even though you haven't had any expenses. That seems to me like a payment rather than an expense. We have to be careful as to what we mean by payment and expenses and distinguish the two very clearly.

But I don't think there is any doubt that in New Zealand and in Australia, there is a strong resistance to paying for gametes.

Mr. James Lunney: Just to make that perfectly clear, payment for expenses is allowed, with some question marks attached to it?

Prof. Ken Daniels: Yes, but many of the people who come don't want any money. Many of the donors never ask about money, I think partly because we've actually introduced a culture in which this is a bit like blood. We don't pay for blood in New Zealand. In America they do pay for blood. You don't get paid for making a donation of blood in Canada, I don't think. There's a whole tradition and history that says you've given something, and that's the kind of motivation we really want to encourage. That's seen as important.

Mr. James Lunney: Thank you very much, Professor Daniels.

The Chair: Thank you very much, Professor Daniels. We appreciate your time and effort, and thank you for your work in this field, from which we are now benefiting. May we offer you our best wishes for your future work. Thank you again.

Does everybody have the same understanding that I do that for two weeks now we've been waiting for the second hour tomorrow so that we can discuss things among ourselves? Is that your understanding?

Mr. James Lunney: Who's the witness tomorrow?

The Chair: Just a minute.

Did you expect that in the first hour tomorrow we would have witnesses and in the second hour tomorrow we would have a discussion among ourselves? Is that what you remember?

An hon. member: I don't know.

Mr. Stan Dromisky: I don't remember. I'm involved in too many committees to remember.

The Chair: Okay. Well, I remember. It's very important, because I thought I had this agreement with the staff, and I thought I communicated to you all that the second hour on Thursday of this week would be dedicated to us clarifying some of the things we're not sure where the committee stands on.

An hon. member: Yes, that's correct.

Ms. Nancy Miller Chenier (Committee Researcher): Can I just speak to that?

The Chair: Yes.

Ms. Nancy Miller Chenier: Tomorrow is your last meeting of witnesses, as was indicated on the work plan, and there are two gaps that were identified by members of the committee.

The Chair: By Ms. Wasylycia-Leis—

Ms. Nancy Miller Chenier: No—

The Chair: Who else?

Ms. Nancy Miller Chenier: And others.

The Chair: Okay.

Ms. Nancy Miller Chenier: One was equivalency. We have nothing on the record—

The Chair: Clause 41.

Ms. Nancy Miller Chenier: —about clause 41. I shouldn't say we have nothing on the record, but we needed a bit more clear guidance on that clause. The other aspect was the disability community. They had been booked for the travel week and were unable to come, and they were unable to come on the Monday of this week, where we had filled in witnesses. So some people want to make a statement to the committee tomorrow.

Mr. Rob Merrifield: That's the disabled community?

Ms. Nancy Miller Chenier: Yes.

The Chair: So I think they planned to have the equivalency as one hour and the disabled as another, which eliminates the possibility of us discussing. On the other hand, what we could do is just let every witness talk and then say, “Thank you very much” and not question them, and reserve that second hour for ourselves. I'm at your pleasure.

Mr. Rob Merrifield: That would be fine. If there are some questions, they will probably be to the equivalency one. As long as we have the opportunity to follow that up individually with them, that will probably be fine.

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The Chair: Okay.

I'll also remind you of the second part. Is that okay with you, Dr. Dromisky and Madame Thibeault?

Mr. Stan Dromisky: Yes.

The Chair: Okay.

[Translation]

Ms. Pauline Picard: Madam Chair, I would like to know what you mean by equivalent. Is it the regulations—

[English]

The Chair: It's clause 41, the provincial equivalency. I think it's subclause 41(1) in the draft legislation. It's like the opting-out clause.

Mrs. Pauline Picard: Okay.

The Chair: So we'll go forward with that plan.

You'll also recall that tomorrow we were supposed to meet from 11 a.m.—not 11:30 a.m.—until noon, then take a break to go into this IPU meeting, and then come back for the second hour at 12:30 p.m. or 12:40 p.m., whenever we can, after we've voted. I asked the committee this about ten days ago.

Mr. Stan Dromisky: Yes, and we agreed.

The Chair: Thank you.

This meeting is now adjourned.