Alison Scheidler

Final Seminar Paper

May 17, 2002

Embryonic Stem Cell Research – A Balancing Approach

Introduction

Today’s Legislatures are continually confronted with

debates concerning the bio-life sciences such as cloning or stem

cell research.[1] These controversial areas of research are very

similar in their underlying debates though each does have its

own variations on the arguments for or against developing the

technology.[2] United States legislatures implemented human

embryonic stem cell (ESC) regulations just this past year[3] and

have since faced several other bills regarding stem cell

research along with a growing number of legislation concerning

other bio-life science research. Presently, the United States

Senate is debating competing bills to ban cloning either

entirely or to allow therapeutic cloning for use with stem cell

technology.[4] Though the scope of this paper is restricted to

analyzing the development of ESC regulations the theory behind

the balancing approach advocated herein is applicable to the

development of regulations in the other bio-life science

research areas as well.

The new ESC regulations announced August 9, 2001 were

created in response to increasing pressure from the National

Institute of Health (NIH)[5]

, scientific researchers, the medical

community, and the public at large.[6]

These regulations allow

federal funding for human embryonic stem cell (hESC) research

conducted on approved human embryonic stem cell

lines.[7] Following the announcement, the NIH published the ESC

Registry listing seventy-two approved stem cell lines.[8]

This Note will propose that the present regulations on ESC

research are too restrictive and that they were developed with

too great of a focus on public morality. This Note will propose

that appropriate ESC regulations should be determined using a

balancing approach that weighs multiple factors. The factors

suggested in this Note include the effect the regulations will

have on our country’s economy, health, leadership positions both

scientifically and morally, and public morals encompassing both

sides of the issue. In applying this balancing theory, this

Note concludes that the United States should loosely regulate

embryonic stem cell research, imposing less restrictions at this

early stage in the development of stem cell research.

First, this note will set forth a basic embryonic stem cell

overview disclosing the development in this area of research and

the basic underlying science. Next this note will present the

development of regulations in the United States for ESC research

and describe the present regulations now in effect. Third, this

note will examine the factors that should be used in determining

how ESC research should be regulated. Finally, this note will

conclude with a proposed ESC regulation system that will reduce

the present restrictions on ESC research.

I. Background

A. Stem Cells – The Basics

Cells are the basic building blocks of life.[9] Some cells

survive on their own while other cells have evolved into complex

organisms.[10]

The average human body is composed of about a

thousand million million cells.[11]

Within complex organisms like

human beings cells are organized into tissues, the tissues into

organs, and the organs grouped together by common function into

systems which act in a coordinated manner to maintain an entire

organism.[12]

There are over 200 types of cells in the human

body.[13]

These cells are organized into four types of tissues:

muscle, nervous, epithelial, and connective tissues.[14]

The

logical question that follows is, what makes these cells so

different from one another that they form the four completely

separate and distinct tissues of the human body?[15]

The answer

lies in the mysterious DNA housed in the nucleus of the cell.

Every somatic cell in the body contains the genetic

material or DNA for the entire organism.[16]

It is estimated that

the genetic material contained in the nucleus of a single cell

would stretch to be about two meters in length.[17]

With that

amount of information stored in the cell’s microscopic nucleus,

cells have had to evolve efficient means of getting to the

information they need and quickly passing over unnecessary

information.[18]

Imagine for a moment a library filled with all the books in

the world. Now imagine that the library had to fit in one small

building. One method to conserve space would be to place the

books on movable rows of shelves and place the shelves directly

adjacent to one another only sliding the shelves apart when

someone had to reach a book shelved between the two rows. Now

imagine the difference if the librarian knew that the only books

the library’s users would want to look at were biology text

books, then the librarian could make access to these books

easier by pushing together all the rows of books in the other

subject areas while leaving openings between the rows containing

biology texts. Instead of constantly having to move the rows

for its users, the library would be easily accessible for use

day in and day out while still containing all the other books

within its walls.

This is essentially the approach the nucleus of the cell

takes for storing and using its genetic information, only

instead of a librarian determining which rows of books to leave

open, cellular signal direct the cell as to which DNA to leave

accessible. These cellular signals occur during the

developmental process and result in the cell’s

differentiation.[19]

A cell is differentiated when it has

developed into a specific type of cell such as a nerve, muscle,

or tissue cell.[20]

Differentiation occurs after a cell’s nucleus

has been imprinted so certain portions of its DNA are tightly

wrapped making it inaccessible thereby allowing the cell to more

efficiently locate the DNA it needs to perform its designated

function in the organism.[21]

DNA directs the cell much like a

computer program directs a computer.[22]

The nucleic acids that

compose the DNA are arranged into gene sequences.[23]

These genes

code for specific proteins that a cell will produce.[24]

Genes

interact with one another and with the environment in

determining the features of a phenotype.[25]

Although the different types of cells in the body perform

different functions and therefore use different genes or

different portions of their DNA meaning that different portions

of the DNA are left open in the nucleus for the cell to read,

all of the cells derive from the same origin, the totipotent

cells of the human embryo.[26]

A totipotent cell has the ability

to form any type of cell found in the human body and is even

uniquely capable of developing into a complete embryo by

itself.[27]

During development cells can either replicate,

multiply without modifying the organization of their DNA, or

differentiate, multiply while changing their genetic

potential.[28]

Once a cell has differentiated it can no longer

form an entire organism by itself.[29]

Rather, the cell is

limited to performing a particular function for the organism as

a whole.

Up until the eight-cell stage of development each cell of a

mammalian embryo is totipotent.[30]

This ball of cells is called

a blastoceol.[31]

At the next stage of development the cells

multiply becoming 16 cells and the blasteoceol forms a

blatocyst, a highly developed fertilized cell consisting of 100-

300 undifferentiated cells to the point where it is ready to

implant into the wall of the uterus.[32]

The cells that line this

inner-wall have differentiated so they are now

pluripotent.[33]

This means that if they are removed from this

ball of cells, these cells could no longer form an entire embryo

by themselves.[34]

However, pluripotent cells are able to form

any of the different types of cells in the body – tissue,

nervous, or muscular.[35]

It is these cells that are referred to

as embryonic stem cells.[36]

Besides being pluripotent, able to differentiate into any

type of cell in the human body, ESCs are also capable of

unlimited undifferentiated proliferation in vitro.[37]

This means

ESC can replicate indefinitely creating a multitude of exact

copies of themselves. This ability makes them exceptional tools

for scientists to use because it provides scientists with a

large supply of identical cells to experiment with. These

identical copies of ESCs are called stem cell lines.

There are two other types of stem cells – adult stem cells

and embryonic germ cells. Discussions concerning the use of

these other two types of cells for research are beyond the scope

of this Note.

B. Stem Cells – The Potential

The ability of stem cells to differentiate into any cell

type in the body has captured the attention of the medical

community.[38]

Their potential uses range from replacement cells

and tissues that can be used to repair damage caused by disease

or injury to providing a means to study specific diseases or the

developmental process itself.[39]

Stem cells can be

differentiated in a controlled manner to form liver cells, bone

cells, nerves cells, skin cells, blood cells, and more.[40]

These

cells can then be implanted into an individual replacing the

damaged cells or tissue.[41]

For victims of MD, spinal cord

injury, severe burns, blood diseases and others, stem cell

research provides a ray of hope that one day they could step

beyond the confines of their disease or injury.

Stem cells further excite the medical community because of

their potential to teach scientists and doctors alike about the

cellular, genetic world they have been trying to conquer for the

past two decades.[42]

The mystery of how an embryo develops has

eluded scientists along with the intricacies of the majority of

the genetic diseases. ESCs provide a way for scientists to

study the effects of the signals sent during the developmental

process with the potential benefit of reducing birth defects and

increasing the success of assisted reproduction.[43]

Further understanding exactly what a diseased cell is

doing, how it is performing or failing to perform, can help the

medical community better treat and potentially cure these life-

altering diseases.[44]

Studies of how a gene acts or fails to act

have already resulted in the prevention and cure of several

diseases.[45]

For example, understanding the genetic cause of PKU

lead to the present treatment a diet free of

phenylalanine.[46]

The discovery of a genetic disorder and the

study of how that disorder behaves differently from other

similar cells may provide the best hope for an environmental

treatment of it.[47]

ESC’s provide an opportunity for scientists

to thoroughly study cells carrying these genetic diseases,

increasing the potential discovery of treatment and cures.[48]

Outside of medicinal benefits and study, ESC can also help

forensic scientists. The new practice of identifying criminals

genetically is often hindered by the size of the sample provided

to the technicians.[49]

Using somatic cell nuclear transfer

(SCNT), the DNA contained in the small sample can be inserted

into an ESC and the sample size increased through the

undifferentiated proliferation of the stem cell.[50]

Thus,

providing the technician with a larger genetic sample for

testing purposes.

Yet another benefit of stem cells comes to light under the

guise of toxicity testing.[51]

Presently toxicity testing is

conducted on animal cells or bacteria.[52]

If a drug is effective

at low concentrations in vitro or in a petri dish, then there is

the potential that it might be successful in vivo at low enough

concentrations to not be toxic.[53]

Though these tests do shed

some light on the toxic effects of chemicals, animal cells and

bacteria cells are different from human cells and scientists

cannot be sure without testing toxicity on human cells what

potential effects there might be.[54]

C. Alternatives To Stem Cell Research

Opponents of ESC research argue that there are less

controversial alternatives to research then ESC research such as

research on ESC from umbilical cord blood and research on adult

stem cells.[55]

Though both of these alternatives have had some

success, neither provides a definitive solution and both have

shown potential limitations to their use.[56]

At this early stage

in stem cell research it is dangerous to limit our potential

results by restricting our available resources.[57]

The delay in

the development of stem cell technology equates to a loss of

life for those desperately awaiting treatment.

Further, two new studies released online by Nature on March

13, 2002 cast doubt on adult stem cell ability to convert into

any cell type to fight disease or replace faulty

organs.[58]

These two new studies cast doubt on previous research

that had shown adult stem cells were capable of transforming

into multiple types of cells found in the human body by showing

that the real reason the cells dedifferentiated was the fact

that they merged with the stem cells placed in the perti dish

with them.[59]

These merged cells were found to contain twice the

number of chromosomes as normal.[60]

The researchers that

observed this phenomenon fear that this might have happened in

the previous reports of successful transformation of cells

fooling scientists into believing the adult stem cells had

transformed themselves into less differentiated cells.[61]

These

two research papers call into question all of the previous data

generated with adult stem cells.[62]

In light of the uncertain

expectations in all areas of stem cell research and in light of

the enormous medical potential stem cell research possesses, all

avenues of stem cell research should be utilized.

D. The Importance of Federal Funding

For the fiscal year of 2003, the United States government

will spend $112 billion dollars on research and development with

$26.5 billion directed to the National Institute of Health,

which funds most of the United States Biotechnology

research.[63]

The federal government funds around 85% of the

sponsored research conducted.[64]

Therefore, the lack of funding

from this arena has an inhibiting effect.[65]

The withdrawal of

government funding will slow this research but it will not stop

the research from continuing.[66]

Privately funded research and

research sponsored overseas will continue to explore this realm

of research and will do so without the comprehensive ethical

oversight provided by United States human subject

regulations.[67]

II. Stem Cells – The Regulations

Though relatively new in the public’s mind, embryonic stem

cell research has been a matter of debate for some time. The

Ethics Advisory Board submitted a report to Congress as early as

1979 that declared it was acceptable for research on human

embryos to be conducted as a means of evaluating In vitro

Fertilization Clinics (IVF).[68]

The 900 - page report was never

acted on and no legislation to this effect was ever

created.[69]

When the government finally began regulating this

field, the first Bush administration set forth an outright

ban.[70]

At the start of the Clinton era, this moratorium was

repealed followed by Congress passing the NIH revitalization Act

of 1993, which created guidelines for fetal tissue

transplantation.[71]

In 1994, an NIH report created by an

interdisciplinary advisory panel appointed by the NIH strongly

encouraged research to be conducted on unused embryos from IVF

with the consent of parents and a narrow majority approved of

the creation of the embryos for research purposes.[72]

Clinton

publicly disagreed with these regulations and before they could

be implemented the Department of Human Health and Services

(DHHS) 1994 Appropriations Act blocked federal funding for ESC

research by attaching prohibitions to the annual appropriations

bill that funds the NIH.[73]

This amendment was called the Dickey

Amendment and prohibited research resulting in the destruction

of embryos.[74]

This amendment was reenacted annually until

finally being allowed to expire on September 30, 2001.[75]

In 1998, the private culturing of ESCs fueled the

smoldering debate concerning ESC research. In 1999, The

National bioethics advisory committee recommended funding for

the derivation as well as the use of unneeded embryos.[76]

This

report was considered by the NIH as they created their

regulations.[77]

The NIH using a specific definition for

embryonic stem cell determined that they could properly approve

research conducted on derived stem cells without violating the

DHHS Appropriations Act.[78]

Though Clinton approved of this

interpretation of the DHHS appropriations act, President Bush

the incoming president did not agree with the proposed NIH

regulations.[79]

The Bush administration announced on August 9,

2001 to allow ESC research, but with more restrictions then

those provided in the NIH proposed regulations.[80]

The present

federal regulatory scheme does not affect privately funded

research.[81]

The current state of regulation allows stem cell research

to be conducted on pre-existing cell lines derived in an

approved manner prior to President Bush’s August 9, 2001

announcement.[82]

To be eligible for federal funding the human

embryonic stem cell line must have been derived from excess

embryos created for fertility treatments by couples that gave

their informed consent free of any financial inducements.[83]

NIH

has released a list of 72 cell lines that meet this

criteria.[84]

Research on any other cell lines will not be

eligible for federal funding. Further, there are restrictions

on the type of research that can be conducted in these cell

lines.[85]

III. Stems Cells – The Balancing Factors

In determining appropriate regulation several factors

should be considered including morality, potential loss of

leadership position, lack of utility in existing stem cell

lines, lack of diversity in cell lines, and loss of

scientist. All of these factors deserve consideration when the

government determines whether or not it is able to support

embryonic stem cell research and no one factor should be allowed

to dominate this balancing approach. Presently, the moral

position is given far too much weight in this analysis. In

setting forth and analyzing the factors below this Note will

argue that in light of the competing moral positions this factor

should be given the same weight as all other factors in this

balancing approach.

A. Morality

As presented previously the potential benefits of ESC

research are immense and the research has only just begun. Now

that a stem cell has been described and its potential benefits

recited, the question becomes why is the federal government

hesitant to support this research? There are many sides to the

debate over ESC research. And many of these sides are not new

arguments specific to the ESC debate such as, the clash of

religion and science, the promise of technology to improve man’s

condition, the danger that this progress will lead to the

destruction of humanity along with others.[86]

ESC research

merely provides the conduit for society science and religion to

once again address these issues.[87]

The moral debate concerning ESC research is an ever-

expanding topic. Further, there are competing goods at stake

concerning ESC regulations.[88]

Morality is an elusive topic in a

nation as large as the United States making it hard to claim

that a single morality exists. This Note does not claim to

cover every facet of the argument but it will address the

central morality arguments for both sides. The basic moral

arguments against ESC research concern the origination of ESCs

and how the developments in ESC technology will affect

society. The basic moral arguments for ESC research is the fact

the excess embryos are designated for destruction whether or not

they are used for research, and the fact that by refusing to

conduct this research, millions of individuals will suffer from

diseases that could potentially be alleviated by ESC research

developments.

i. Origination of ESC

Hidden behind the ESC’s glowing potential lurks the shadow

of its origination. Opponents of ESC research fear we are

treading upon the value of human life and opening a pandora’s

box to the moral and ethical dilemmas inherent in sacrificing

another’s potential life for the good of society.[89]

This fear

is based on the fact that when the ESCs are removed from the

pre-embryo or blastocyst stage, the pre-embryo is destroyed,

meaning it can no longer develop into an embryo and later into a

fetus.[90]

This destruction of a potential life leads the

conservative pro-life sector to denounce ESC research as

immoral.[91]

Supporters of ESC research argue that the embryos used to

create ESCs are designated for destruction as it is and as such,

it is more acceptable to use the embryos to promote life then to

simply discard them as waste.[92]

To better understand their

argument one needs to understand a little about the in vitro

fertilization procedure. The excess embryos used to create ESC

lines come from the in vitro fertilization process.[93]

This

process, IVF, is an uncertain procedure even though it has been

practiced in private clinics for many years. Because of the

high cost of the procedure and its uncertain success, patients

often remove and fertilize multiple eggs.[94]

These excess

embryos are then stored to be implanted later if the first

attempt at implantation is unsuccessful.[95]

Generally, if the

first process is successful the couple can then chose to either

discard these embryos, use them later to create another child,

donate them to other couples, or donate these to research. If

the first attempt is unsuccessful, these stored eggs can be used

in a second implantation procedure.[96]

Opposition towards the use of these excess embryos to

create ESCs appears very hypocritical in light of the fact that

there is a lack of a moral uprising over the IVF procedures

themselves, which create the excess embryos and this

situation. The cryogenic freezing process used to store embryos

for later use destroys 25% of the embryos stored.[97]

One source

speculates that hundreds of thousands of unused embryos have

been destroyed in fertility clinics.[98]

Yet, this enormous

waste of life has not raised nearly the issues that the use of

few dozen embryos to create ESC for medical research has in the

public moral spectrum.[99]

Presently, no law exists preventing the destruction of

these embryos, nor is such a law likely to be implemented in

light of the constitutional right to not procreate and the

established abortion laws.[100]

The general practice of the

government is to stay out of the procreative choices of

individuals, therefore making it difficult for the government to

make the leap to requiring the excess embryos to be either

implanted or adopted.[101]

In this situation, the embryos

ultimate designation is destruction, and the only question

remaining is how the embryo will be destroyed.

President Bush himself rationalized allowing federal funds

to support ESC research on existing stem cell lines because the

life and death decision has already been made.[102]

Using his own

rationalization, President Bush should also support the

derivation of new stem cell lines from the unwanted excess

embryos created through the in vitro fertilization process. Each

year, thousands of spare embryos created in infertility

procedures are routinely destroyed at the request of their

progenators.[103]

This makes the relevant ethical question

whether these embryos should simply be thrown away or used for

human benefit.[104]

To those desperately needing the potential

cures promised by ESC research, the useless, wasteful

destruction of these potential sources of life symbolize the

destruction of their hopes and dreams.[105]

According to data from the Center for disease Control

National Center for Health Statistics, 3,000 Americans die every

day from diseases that may in the future be treatable with ESC

therapy[106]

, implying that it is not ethical to not support

research that could alleviate the suffering of millions of

Americans afflicted with devastating diseases.[107]

Sweden, the

country presently leading in ESC research, is an example of a

country that believes the enormous medical benefits derived from

ESC research establishes that this research is in the best

interests of their public health and therefore,

ethical.[108]

Advocates of ESC research in the United States

believe our government should make the same determination.

There are strong moral arguments both for and against ESC

research and it is important that these arguments be considered

when ESC regulations are determined.[109] However, morality is

only one factor of several that should be considered in

determining appropriate ESC regulations and in light of the fact

that morality speaks so strongly on both sides of the argument,

legislators should not give this factor greater weight then the

other factors used in this balancing approach.

B. Leadership

Another concern is how ESC technology will be used by

nations with less respect for human life then the United

States.[110]

The example commonly used is China. It isn’t hard

to speculate that the Chinese government, not known for

respecting human life to the degree of the United States, will

use the technological advances of the United States to progress

beyond their cloning of rabbit embryos containing human DNA to

clone human fetuses for experimentation or to use the ability to

screen for genetic disorders to produce children made to

specification.[111]

However, the United States is not considered

the leading nation when it comes to ESC research and as such

whether or not we participate in this research is not going to

affect China or any other countries ability to abuse the

technology. In fact, if we do back away from this technology,

it will more then likely weaken our position to influence its

use, which in the end may be the greater moral wrong.

Examining the present situation of countries that refused

to enter the race to discover the human genome or refuse the

participate in stem cell research, provides the background to

predict what will happen to the United States if we continue to

strictly regulate stem cell research.

Examining, other countries where the government has either

failed to support a rapidly growing industry or crippled the

industry with strict regulations shows such government

intervention has lead to the countries being left behind in the

specific technology.[112]

Italy is a prime example of country

that has lost hope for actively participating in genomic

research.[113]

The strict regulation by the conservatively

controlled government has lead to the flight of their young

scientists to other countries, shrinking intellectual property

patent awards, and the ultimate outcome of the country being far

behind in genomic technology.[114]

German researchers are also

having problems with delays in their government resulting in ESC

research being crippled by delays awaiting for government

approval.[115]

Whereas Sweden with very lax stem cell regulations

has become the largest single source of stem cell lines approved

on the NIH stem cell line registry.[116]

Canada observing that

their lack of funding for human genomic research had resulted in

a loss of scientists to the United States has made great efforts

to reenter the genomic revolution especially in the area of stem

cell research.[117]

Using large tax incentives, providing

investment opportunities and a biotechnology commercialization

fund has resulted in drawing its scientists back into Canada and

moving itself into a position of leadership in stem cell

technology.[118]

C. Material Limitations

Placing a limit on the number of cell lines available may

place roadblocks to medical progress, some of which may take

years to overcome.[119]

Pre-emptively limiting the materials with

which researchers are able to work early in its progress may be

extremely detrimental costing years and possibly even

lives.[120]

Some critiques claim the only parties to benefit

either directly or indirectly from Bush’s stem cell policy are

the handful of companies whose derived stem cell lines are

approved by the NIH.[121]

Under the Bush policy, no new cell

lines can be created and be eligible for federal

funding.[122]

This creates several difficulties with our ability

to benefit from the limited ESC research that has been and is

being conducted presently.

i. Utility

The NIH initially claimed that all the cell lines

identified and listed in the registry were viable, meaning they

shared the expected characteristics of human ESCs.[123]

However,

the NIH has admitted that there might be supply problems adding

that the derivations of the cell lines are still in the early

stages of characterization and thus may not be immediately

available.[124]

In fact when further questioned Tommy Thompson,

the President’s Secretary for Health and Human Services,

conceded there were only 24 stem cell lines currently

useable.[125]

Further concerns include whether or not the stem

cell lines are actually immortal and whether they may in the

future accumulate genetic errors.[126]

Additionally there is the

problem with the FDA restrictions on Xenotransplant products

that would foreclose use of any of the presently derived cell

lines in a cellular therapy context.[127]

All of the stem cells

presently in existence are believed to qualify as

Xenotransplantation products under these FDA guidelines because

the cells were grown using mouse feeder cells and bovine

serum.[128]

A new technique has been developed to sustain human

ESC without the use of animal products, but any cell lines

developed and maintained by this technique would not be

available for federal funding under the present

regulations.[129]

Therefore, their utility as potential future

therapies is questionable.

ii. Diversity

Limiting research to be conducted only on the 72 existing

stem cell lines clearly limits the genetic diversity available

for stem cell research. While human beings have much in common,

are genes are diverse. It is estimated that about 7% of the

proteins differ from individual to individual.[130]

A common problem with any tissue or cellular

transplantation is the potential for immune

rejection.[131]

Immune rejection problems happen because the

human body has evolved a mechanism to protect itself from

foreign invaders.[132]

One method of protecting itself uses cell

surface proteins known as human-leukocyte-associated

antigens.[133]

These antigens are basically cellular fingerprints

and just as it is rare for two individuals to share the same

fingerprints it is rare for two individuals to share the same

antigen markers on their cellular surface.[134]

When the cells of

the immune system identify a cell with foreign HLA antigens, the

cell is destroyed, this complicating the transplantation

process.[135]

In order for a transplant to be successful the HLA

antigens on a cells surface must be matched as closely as

possible. The ability to match these antigens is severely

restricted when the starting pool for HLA diversity only

consists of 72 possible options.

The diversity of the 72 stem cell lines is further

challenged by the known sources for these stem cell lines. The

majority of these cell lines were derived from Caucasian

couples.[136]

This lack of racial diversity in the stem cell

lines is unlikely to be compensated for by the private

sector.[137]

The private sector’s sole purpose for conducting the

research is to make a profit.[138]

A profitable business rarely

directs its attention to the needs and desires of the minority

rather their focus is on the majority population as

well.[139]

Meaning the minority’s genetic interests will be under

addressed in the ESC research arena.

iii. Brain Drain Phenomenon

Scientists work where there is funding and support for the

type of research they desire to perform. The federal government

funds around 85% of sponsored research conducted in the United

States. Therefore, it is important to have federal funding for

the field of research a scientist wants to research. Even

though funding is now available the restrictions on availability

of stem cells to perform the work, the restrictions on the type

of research that can be conducted on the stem cell lines once

you get access to them, the requirement that there is no

intermingling between federally funded research and privately

funded research, the licensing restrictions on several of the

available stem cell lines and the restrictive hostile

environment towards ESC research all combine to discourage

scientists to base their research efforts in the United States

when Britain, Sweden, and Canada to name a few are far more

supportive of their research efforts.[140]

In fact, Britain is

considered one of the most attractive research and development

locations in Europe.[141]

Private companies holding stem cell lines such as CyThera,

Bresagen, and ES Cell International will provide their cell

lines for free but will ask for first rights to license any

resulting intellectual property.[142]

Recognizing these

disincentives, NIH has drawn up an agreement with

WiCell,[143]

that provide human ESC with as few strings as

possible.[144]

Further researchers can avoid obligations by

seeking to work with private companies.[145]

Ironically the list of approved cell lines released by the

NIH represents a casualty list reflecting how past and present

regulations have already impacted ESC research in the

US.[146]

Only 20 of the 72 stem cell lines originate from US

laboratories and only 7 of those from public

laboratories.[147]

The countries conspicuously absent are those

still burdened by a moratorium on ESC research such as France,

Germany, and Italy.[148]

The effects are obvious, if a government

prevents its countries scientists to research in a particular

field it will lose its researchers, lose the economic benefit

resulting from such research, and have a hard time reentering

the research field after being lax at the technologies

inception.[149]

IV. Recommended Regulations

There should be regulations that govern federally funded stem

cell research, but these regulations should be more closely

mirror with the public’s actual concerns. I propose that

federal funding should support the derivation of embryonic stem

cell lines from the excess IVF embryos. These stem cell lines

should be derived from excess in vitro fertilization eggs

donated by couples that gave their informed consent free of any

financial inducements. This will allow us to increase the

sample cell lines in existence creating greater diversity among

the stem cell lines. Further, this will allow scientists to

create stem cell lines that would not violate the FDA

Xenotransplantation regulations, by creating cell lines without

the use of any animal materials. It is in the best interests of

the United States to put itself at the forefront of this

research so they can understand the technology and help

influence its application in the medical community.

V. Conclusion

In light of the detrimental effects the present ESC

regulations have on the United States scientific and medical

communities, the present regulations on ESC research need to be

reexamined. There is no reason to severely restrict federally

funded research by limiting it to 72 cell lines that are not

representative of the population as a whole.[150]

There is no

reason to not support using the excess embryos from in vitro

fertilization clinics to establish further cell lines. In

balancing the factors that should be considered the morality

concerns about ESC research are outweighed by the potential

benefits that could result, by the extensive knowledge waiting

to be discovered, and by the loss of the United States position

as a leader in the scientific medical community.

The regulations recommended in this Note will still support

the public policy of not promoting the destruction of the embryo

because only embryos already designated for destruction may be

used and the suggested regulations will not support the creation

of embryos for research purposes alone. Further, these

suggested regulations allow for ESC lines that would not violate

FDA regulations to be created thereby not impeding future

transplantation therapy.

[1]

Robert Lee Hotz, Book Review Our Posthuman Future, Los Angeles Times, May 5, 2002 [2]

Id. [3]

President George W. Bush, Remarks by the President on Stem Cell Research, August 9, 2001 (transcript available

at http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html). [4]

Similar arguments are made to support therapeutic cloning for use with stem cell technology as are made with

ESC research. Jeremy Manier, Cloning Backers bank on science, Chicago Tribune Company Chicago Tribne, May

7, 2002. The Brownback proposal would ban all human cloning while the Kennedy and Feinstein bill would permit

cloning for research. Id. Therapeutic cloning is claimed to be a misdescriptive term for cells used in research

regarding concerous cells cloned because the clone is of the tumor not the individual and as such these cells contain

numerous genetic flaws. Id. [5]

On August 25, 2000 NIH released guidelines to regulate federally funded embryonic stem cell (ESC)

research. After consulting the Department of Health and Human Services (DHHS) General Counsel, NIH

determined that federally funded research on human ESCs would not violate the DHHS appropriations Act of

1999. The DHHS Appropriations Act prohibited human embryo research, and the director of NIH determined ESCs

are not by definition human embryos. Neil Monro, Political Science, The National Journal, September 16,

2000. This bold step by NIH towards promoting ESC research ignited the ESC research debate raising it to a status

of such importance that it became a presidential election issue. President Bush campaigned against supporting

embryonic stem cell research and many proponents of such research feared the action he would take once in

office. Surprisingly Bush did not choose to ban ESC research. Rather, Bush chose to allow federally funded

research to continue but within specified limitations or restrictions. [6]

NIH Human Embryonic Stem Cell Registry, http://escr.nih.gov/. [7]

Id. [8]

Id. [9]

Dawkins, Richard, The Selfish Gene 21-22, (1989). [10]

Id. [11]

Id. at 22. [12]

Stuart Ira Fox, General Physiology, fifth edition, 1996, 9. [13]

Albrets, Bruce et al., Molecular Biology of the Cell 36 (3d ed. 1994). [14]

See Fox, 9.

[15] The cells that compose the four tissues differ greatly. Neurons and neuroglia are the cells of the nervous

tissue. The neuron basically consists of three parts: a cell body, dendrites and axons, whereas the neuroglia bind the

neurons together. Epithelial tissue cells consist of membrane cells and gland cells. Connective tissue cells consist

of blood cells, cartilage, bone and connective tissue proper. All of these cells differ from one another in function

and form. Muscle tissue consists of either the skeletal muscle cells, the long thin fibers or myofibers, cardiac muscle

cells, the short branched interconnected myocardial cells, and smooth muscle cells arranged longitudinally or

circularly throughout the different areas of the body. Id. [16]

Most cell in the body have a single nucleus. The nucleus is surrounded by a nuclear envelope which is composed

of an inner and outer membrane which at various points are fused together by nuclear pore complexes. Each of

these complexes has a central opening or nuclear pore through which small molecules may pass by diffusion

allowing the nucleus to communicate with the cell that houses it. RNA the messenger protein passes through these

pores. [17]

Nesse, Randolph M., PH.D et al., Why We Get Sick The New Science of Darwinian Medicine, 92, 1995. When

this is multiplied by the ten trillion cells in the human body our DNA would stretch 20 billion kilometers about the

distance to the planet Pluto. [18]

About 95% of the DNA is never translated into proteins. The remaining 5% of human DNA can be divided into

100,000 protein-coding genes. Id. [19]

www.nih.gov/news/stemcell/achieve.htm “What would you hope to achieve from human pluripotent stem cell

research?, National Cancer Institute, April 26, 2000. Last visited May 15, 2002 [20]

www.acs.ucalgary.ca/~browder/Cell_Diff.html, last visited May 15, 2002. [21]

Id. [22]

The nucleus is surrounded by a nuclear envelope, which is composed of an inner and outer membrane, which at

various points are fused together by nuclear pore complexes. Fox, at 57. Each of these complexes has a central

opening or nuclear pore through which small molecules may pass by diffusion allowing the nucleus to communicate

with the cell that houses it. Id. RNA the messenger protein passes through these pores. Id. [23]

Id. Each gene is several thousand nucleotide pairs long. The DNA in a human cell contains 3 billion to 4 billion

base pairs. This is enough genetic information to code for at least 3 million proteins, but only a fraction of our DNA

is actually used to code for proteins. [24]

Each gene contains the code for the production of a particular type of messenger RNA (mRNA). Id. at 57. This

messenger RNA provides the code for a specific type of protein. Id. Genetic expression occurs in two stages

genetic transcription, the creation of the RNA in the nucleus, and genetic translation, the creation of the protein from

the mRNA after it has left the nucleus through one of the nuclear pores. Id. At 58 [25]

See Nesse at 96. [26]

Alberts, Bruce, et al., Molecular Biology of the Cell 32 (3d edition 1994). [27]

Department of Health and Human Services, Stem Cells: Scientific Progress and Future Research directions F-10

(2001), (available at http://www.nih.gov/news/stemcell/fullrptstem.pdf). [28]

Cite needed. [29]

Id. There is the rare potential for a cell to dedifferentiate, but this phenomenon is rareand outside the scope of

this paper. [30]

Alberts, Bruce et al., Molecular Biology of the Cell 1058 (3d ed. 1994). [31]

http://www.ivf.com/blasteocyst.html [32]

Id. [33]

Id. [34]

Department of Human Health and Services, Stem Cells: Scientific Progress and Future Research Directions, 5

(2001), (available at http://www.nih.gov/news/stemcell/fullrptstem.pdf). [35]

Id.. T. Wakayama et al., Differentiation of embryonic stem cell lines generated from adult somatic cells by

nuclear transfer, Science 740, April 27 2001. N. Lumelsky et al., Differentiation of embryonic stem cells to insulin-

secreting structures similar to Pancreatic Islets, 10:1126 ScienceExpress, April 26, 2001. [36]

Id. This note only addresses the legal issues surrounding embryonic stem cells. Another source of stem cells are

the embryonic germ cells that come from the primordial germ cells of the developing fetus or embryo. Department

of Health and Human Services supra note ____. The tow types of ESCs are similar in man respects, but differ in

their origins and growth characteristics. Id.. [37]

James A. Thompson et al., Embryonic Stem Cell Lines Derived from Human Blastocysts, 282 Science 1145

(1998). [38]

See National Institute of Arthritis and Musculoskeletal and Skin Disease (NIAMS), NIH, March 25,

1999. Response to Senator Specter’s Inquiry “What would you hope to achieve from stem cell research?” In the

future stem cells may be introduced into areas with damaged bone or cartilage aiding in problems such as

ostearthritis or refilling the large gaps in bones following fractures. [39]

Steven L. Teitelbaum, Allow Research Cloning; There are Clear and Appropriate Ways to Permit Important

Research Using Cloning Techniques, While Banning the Cloning of Human Beings, St-Louis Post-Dispatch, April

18, 2002. [40]

Gearhart, J.D., New Potential for Embryonic Stem, 282 Science 1061-1062, 1998. [41]

Irving L. Weisman and David Baltimore, Disappearing Stem Cells Disappearing Science, Science 601, April 27,

2001. Like any tissue or organ transplantation, ESC transplantation would requires addressing the problem of

immune rejection. One solution to immune rejection is to use somatic cell nuclear transfer because using a patients

own DNA may provide one way to circumvent the bodies own natural defense mechanism to attack any foreign

body it comes across. Bruce Alberts, Please Don’t Call It Cloning, 295 Science 1237, February 15, 2002. [42]

Department of Human Health and Services (DHHS), Stem Cells: Scientific Progress and Future Research

Direction, 17 (2001), (available at http://www.nih.gov/news/stemcell/fullrptstem.pdf); Ethical Issues in Human Stem

Cell Research, 1 Report and Recommendations of the National Bioethics Advisory Commission (NBAC) 23,

September 1999. [43]

Department of Human Health and Services, Stem Cells: Scientific Progress and Future Research Direction, ES-1

(2001), (available at http://www.nih.gov/news/stemcell/fullrptstem.pdf); [44]

Id., Ronald M. Green, Stopping Embryo Research, 9 Health Matrix 235, 237, Summer 1999. [45]

See Neese at 106. [46]

Id. [47]

Id. [48]

Bruce Alberts et al., Please Don’t Call It Cloning, 295 Science 1237, February 15, 2002. This benefit of ESC

research is limited to using somatic cell nuclear transfer (SCNT) to import in a patients DNA containing the disease

that scientists want to study. Recent legislation passed by the House of Representatives and under consideration by

congress to ban the cloning of human beings actually describes the use of SCNT. If this proposal is passes this

benefit of ESC research would be severely impaired, even though SCNT performed on an ESC would not result in

the clone of a human being because ESC are incapable of developing into an entire human being. The outcome of

SCNT on an ESC is not to create a copy of the potential tissue recipient, but rather to make tissue that is genetically

compatible with that of the recipient. [49]

NBAC, supra note 42. [50]

Id. [51]

Department of Human Health and Services, Stem Cells: Scientific Progress and Future Research Direction, 17-

18 (2001), (available at http://www.nih.gov/news/stemcell/fullrptstem.pdf). [52]

Stuart Ira Fox, Human Physiology, Fifth edition 1996, 5 [53]

Id. [54]

The toxicity test process usually starts with testing drugs at very low concentrations on in vitro animal or

bacterial cells. Id. If there is success with the low drug concentration, then the testing is moved to animal testing

and then on the clinical trials. Id. More then 90% of the drugs tested in trials on animals are considered too toxic to

proceed. Id. If it could be observed earlier on human cells that a drug was likely to be toxic this could decrease the

testing on animals because less drugs would pass through the first stage in the process. [55]

Gary L. Bauer, Stem Cell Research; Advocate and opponent debate the merits of studies in which scientists

destroy human embryos in hopes of curing diseases CON, The Dallas Morning News, September 3, 2000. A

number of studies have shown that ESCs could arise from another source such as adult stem cells derived from adult

bone marrow cells. Id. [56]

Adult stem cells are difficult to replicate and in limited supplies in the human body with the numbers decreasing

as patients age. Greg Winter, New Alchemy: Bone and Cartilage from a snippet of skin; The New York Times

Company, June 20, 2000. [57]

Id. [58]

Cloning Studies cast Doubt on Efficacy of adult stem sells, Genomics and Genetics Weekly, April 12,

2002.; Cloning Studies cast doubt on efficacy of adult stem cells, Stem Cell Week, April 8, 2002. [59]

Id. [60]

Id. [61]

Id. [62]

Id. [63]

David Crane, Let’s Learn How to Fight the Sandwich Effect, Toronto Star, April 24, 2002.

[64] Association of University Technology Managers, Inc., Autm Licensing Survey, FY 1999, survey Summary 1

(2000), available at http://www.autm.net/surveys/99/survey99A.pdf. [65]

Id. [66]

Robert P. Lanza et al., The ethical reasons for Stem Cell Research, 292 Science 1299, May 18, 2001. [67]

Id. [68]

Science August 24, 2001, 1401 [69]

Id. [70]

Alexander Morgan Capron, Stem Cells: Ethics, Law and Politics, 20 Biotechnology L. Rep. 678, 697 (2001). [71]

Federal Funding of Tissue Transplantation Research, 58 Fed Reg. 7457, Jan. 22, 1993. [72]

Id. [73]

The Balanced Budget Downpayment Act, I, Pub. L. No. 104-99 128, 110, Stat. 26 (1996) [74]

See Consolidated Appropriations ---- FY 2001, Pub. L. No. 106-554, 510, 114 Stat. 2763; Micheal Casey, Can

we rebuild the US Health Care System Medical Industry Today, January 18, 2001. [75]

Id. [76]

Arthur, Breaking the Stalemate: A Prospective Regulatory Framework for Unforeseen Research Uses of Human

Tissue Samples and Health Information, 34 Wake Forest L. Rev. 737, 746. [77]

August Gribbon, NIH Releases Rules for Research on Embryonic Stem Cells, The Washington Times, August

24, 2000. [78]

Ellen J. Flannery and Gail H. Javitt, Analysis of Federal Laws Pertaining to Funding of Huamn Pluripotent Stem

Cells, 2 Ethical Issues in Human Embryonic Stem Cell Research D-6 – D-9, January 2000. [79]

Id. [80]

Constance Holden, NIH’s List of 64 Leaves Questions, 293:5535 Science 1567, August 31, 2001 [81]

Id. [82]

Jeffery L. Fox, US Deliberates on Embryonic Stem Cells, Cloning, 19:9 Natures Biotechnology 791, September

2001. [83]

Id. [84]

Id. [85]

Jeffery L. Fox, US Deliberates on Embryonic Stem Cells, Cloning [86]

Eric Cohen, New Genetics, Old Quandaries, The Weekly Standard, April 22, 2002 [87]

Remarks on Human Cloning Technology, Public Papers of the President, April 15, 2002. The president

continued “we can pursue medical research with a clear sense of moral purpose or we can travel without an ethical

compass into a world we could live to regret.” Life is a creation not a commodity --- speaks more to emotion than to

facts. [88]

See Tina Hesman, Ban’s Critics, Backers Fear Consequences, St-Louis Post Dispatch, April 14, 2002. [89]

Ronald M. Green, supra note 44. [90]

See James A, Thompson et al., Embryonic Stem Cell Lines Derived From Human Blastocysts, 282 Science 1145

(1998) [91]

Alexander Morgan Capron, Stem Cells: Ethics, Law and Politics, 20 Biotechnology L. Rep. 678, 687 (2001);

Green supra note 44. This argument is flawed because what is being evaluated or weighed is how an embryo

destined for destruction should be destroyed. [92]

“If they are going to be destroyed anyway, shouldn’t they be used … for research that has the potential to save

and improve other lives?” President George W. Bush, Remarks by the President on Stem Cell Research, august 9,

2001 (transcript available at http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html). [93]

The in vitro fertilization process involves artificial insemination of an egg in a laboratory. Infertility and IVF

Center, St. Louis, Mo., In Vitro Fertilization (available at http://www.ivfctrstl.org/ht-ivf.htm. The resulting embryo

is either implanted in the uterus or undergoes cryogenic preservation after it develops to the four or eight cell

stage. Id. Cryogenic preservation allows embryos to be preserved and stored for extended periods of time in liquid

nitrogen. Jennifer Marigliano Dehmel, To Have or Not To Have: Whose Procreative Rights Prevail in Disputes

Over Dispositions of Frzen Embryos?, 27 Conn. L. Rev. 1377 (1995). If another attempt at pregnancy is desired

than the embryos may be thawed and the implantation process attempted again sparing the female from the physical

stress and pain of hormone stimulation and egg retrieval as well as sparing the couple the excess cost of repeating

the entire procedure a second time. Lee M/ Silver, Remaking Eden, 95 (1998). [94]

http://www.ivf.com.html [95]

http://www.ivf.com/blasteocyst.html; A process called Cryogenic preservation allows embryos to be stored for

many years allowing IVF users to return years later and attempt another pregnancy. http://religious

tolerance.org/res_stem1.htm. Last visited May 15, 2002.

[96] See supra note 64.

[97] http://www.religiostolerance.org/res_stem2.htm Last visited May 15, 2002.

[98] Carl T. Hall, “The Forgotten Embryo: Fertility clinics must store or destroy the surplus that is part of the

process,” SF Gate News, at: http://www.sfgate.com/ Last visited May 15, 2002. [99]

Carl T. Hall, “The Forgotten Embryo: Fertility clinics must store or destroy the surplus that is part of the

process,” SF Gate News, at: http://www.sfgate.com/ Last visited May 15, 2002. [100]

The right not to procreate has been upheld in the courts. Davis v. Davis held that ordinarily the party wishing to

avoid procreation should prevail assuming that the other party has a reasonable possibility to achieve parenthood by

means other then the use of the pre-embryos in question. Davis v. Davis, 842 S.W.2d 588, 593 (Tn. 1992). Further

the court itterrated that if the desire was to donate the embryos to another couple the objecting party has the greater

interest and should prevail. Id. The court in Litowitz v. Litowitz held that the wife’s interest in having the embryo’s

implanted in a surrogate mother was not sufficient to outweigh the father’s interest to not procreate. Litowitz v.

Litowitz, 102 Wash. App. 934. [101]

Both Davis v. Davis and the Lithowitz case support the right to not procreate. In light of this existing precedent,

it would be difficult for the courts to force the progenitors to implant the excess embryos either in themselves or in

adoptive parents. Further, the present abortion laws approve of the destruction of the embryo for any reason at the

will of the mother up to the third trimester which makes it difficult to argue that the embryo which can be destroyed

for any reason up to that point has a right to life when it exists outside the mother. [102]

Jeffery L. Fox, US Deliberates on Embryonic Stem Cells, Cloning, 19:9 Nature Biotechnology 791 September

2001. Further one of the co-authors of the successful restrictive German ESC regulations passed in February of this

year stated in support of the regulations restriction to cell lines created before the passage of the regulations “we

cannot cancel the fact that the embryos were already killed for the existing cell lines.” Again this logic should

extend to cover embryos designated for destruction after their use in the IVF procedure is no desired. Gretchen

Vogel, German Researchers Get Green Light, Just, 295 Science 943, February 8, 2002. [103]

Lanza, supra note 66. This same dilemma is being examined in Australia where ACT Chief Minister Jon

Stanhope points out that the 70,000 spare embryos in frozen storage in Australia if not used for stem cell research

will eventually simply be thrown away. Stanhope continues to support that to cut off research in this field is to cut

off hope ofr a better healthier society. Monika Boogs, Stem-Cell research Breakthroughs Will Light Up Our Lives,

Says Cross, Global News Wire, April 12, 2002. [104]

Id. [105]

Delays in ESC research have a real cost in terms of human suffering. Data from the Center for Disease

Control’s Nationa; Center for Health statistics states that approximately 3,000 Americans die everyday from

diseases that may in the future be treatable by ESC derived cells and tissues. Robert P. Lanza et al., The ethical

reasons for Stem Cell Research, 292 Science 1299, May 18, 2001. [106]

Lanza supra note ____. [107]

Steven L. Teitelbaum, Allow Research Cloning; There are clear ways to permit important research using

cloning techniques, while banning the cloning of human beings, St. Louis Post Dispatch, April 18, 2002. [108]

David Crane, Let’s Learn How to Fight the Sandwich Effect, Toronto Star, April 24, 2002.

[110]

Id. [111]

Id. [112]

Id. [113]

See Nature Biotechnology, 516, June 2001 [114]

Nature Biotechnology, 516, June 2001 [115]

Gretchen Vogel, German Researcher Get Green Light, Just, 295 Science 943 February 8, 2002. [116]

Science, Cloning Carbon copy clone is the real thing, 1443, February 22, 2002. Sweden profited from taking an

early stand on ESC research. The government determined that it was in the best interest of the country’s public

health to pursue ESC research and thus the research was determined to be ethical. Steps Sweden has taken to

develop its bioscience research are continued and increased investments in education and in research, investments in

multidisciplinary research, flexible public financing for collaborative projects between a company and a university

group, increased early stage funding, clear rules and regulations, and increased public awareness and knowledge. Its

position at the forefront of this research is surprising considering the size of the countrey and the resources

available. David Crane, Let’s Learn how to fight the Sandwich Effect, Toronto Star, April 24, 2002. [117]

Nature Biotechnology, 523, June 2001 [118]

Id. [119]

Id.

[120] Id.

[121] Liz Fletcher, US Stem Cell Policy Comes Under Fire, 19:10 Nature Biotechnology 893, October 2001.

[122] Id.

[123] Id.

[124] Id.

[125] Id.

[126] Id.

[127] Id. Presntly the FDA will not allow any procedure involving the transplantation, implantation, or infusion into

a human recipient of either live cells, tissues, or organs from a non-human animal source, or human body fluids,

cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues or organs. Food and

Drug Administration, Guidance for industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning

the Use of Xenotransplantation Products in Humans (2001) (available

at http://www.fda.gov/cber/gdlns/clinxeno0201.pdf). There is a general concern over the spread of infectious agents

of animal origin into the human population that provides the basis for these restrictions. Id. [128]

Jill Carroll and Jim Vandehei, Mouse Cells in Stem Lines May Limit Use, Wall ST. J., Aug. 24, 2001 at A3. [129]

Chunhui Xu et al., Feeder-Free Growth of Undifferentiated Human ESC, 19 Nature biotechnology 971 (2001). [130]

See Nesse, supra note 17 at p. 94. [131]

Bruce Alberts et al., Molecular Biology of the Cell 1229-30 (3d ed. 1994). [132]

Id. [133]

Id. [134]

Id. [135]

Id. [136]

Jon Entine & Sally Satel, Inserting Race into the Stem Cell Debate, Wash. Post, Sept. 9, 2001, at B1. [137]

Id. [138]

Ceci Connolly, Justin Gillis & Rick Weiss, Viability of Stem Cell Plan Doubted, Wash. Post, August 20, 2001. [139]

Id. [140]

[141]

Edward Baumgartner, Novartis says Animal Rights Activists Make It Wary of Increasing Investment in UK, [142]

Liz Fletcher, US Stem Cell Policy Comes Under Fire, 19:10 Nature Biotechnology 893, October 2001. [143]

This is an institute associated with the nonrofit organization Wisconsin Alumni Research Foundation (WARF,

Madison Wisconsin). Id. [144]

Id. [145]

Id. [146]

Liz Fletcher, US Stem Cell Policy Comes Under Fire, 19:10 Nature Biotechnology 893, October 2001. [147]

Id. [148]

Id. [149]

Id. [150]

Jon Entine & Sally Satel, Inserting Race into the Stem Cell Debate, Wash. Post, Sept. 9, 2001, at B1.