Biotechnology
Mary Maier, CSJ
ISSUES OF JUSTICE AND TECHNOLOGY
It is fifty years since the structure of DNA was solved
by Watson and Crick, and we all know that DNA is a
chemical, comes in genes, and is inherited from the
previous generation of each life form, each living
creature. We call it a bio-chemical because it takes
many biological processes to supply each 'daughter' cell
in the living creature with the parents' DNA. And all of
the proteins that are needed for a living creature are
produced under the direction of DNA.
It is thirty years since some scientists decided to try
a process whereby they would insert a special strand of
DNA into some friendly bacteria to have them make
selected proteins which the bacteria did not normally
synthesize. Escherichia coli bacteria happen to have a
circular strand of DNA (plasmid) in each bacterium, so
the chemists used enzymes to open the plasmid in many
E.coli, insert the special DNA, and close the
genetically engineered circle. As a result proteins such
as insulin and juvenile growth hormone were able to be
produced by these genetically 'engineered' bacteria, and
BIOTECHNOLOGY entered the scientific scene.
A whole new vocabulary has emerged since then as
biotechnology extends to genetically engineered crops,
biotech drugs, vaccines, health care products,
diagnostic tools, and more. There are various ways in
which to insert the 'bio' into the 'technology', and
since genes are involved, the term 'genomics' has also
entered the inductrial vocabulary.
An excellent website for current information about
biotechnology is http://www.bio.org, the source of
current information about this area of science which is
affecting so many industries and their products. For
example, biotechnology seeks to address the food needs
of the planet by inserting genes into crops which will
increase their yield without the need for pesticides. Current information from this site directs us to the
fact that there is planned a gathering of world leaders
in Washington, D.C., BIO 2003, from June 21-25, 2003
devoted to "Biotechnology and the Global Impact on
the Science Industry." From the web site one can
download such fact sheets as "Limits of
Biotechnology," "Plant-Made
Pharmaceuticals," "Transgenic Animals Fact
Sheet," "Ethics," and more.
As we become aware of this increasingly versatile but
often mistrusted area of scientific, rapid change, we
pray, "God, we witness unheard of things. We ask
you, God, that like Jesus, we may be a healing grace to
all who live with us in this world... We ask you to let
us be for each other as fertile as seed and as
nourishing as bread and thus lead a happy life." (Huub
Oosterhuis, "Your Word Is Near")
Biotechnology II
Mary Maier, CSJ
Biotechnology has come a long way
since 1973, when two scientists were able to insert a
strand of DNA into bacteria for the purpose of producing
chemicals which are useful to living systems, such as
insulin. The name ‘recombinant DNA’ was then a new
term in the sciences, and for about ten years concern
for the safety of this process caused it to be
restricted from development by industry.
Now,
in the year 2003, we find many variations of the basic
process of inserting a gene into a host for the purpose
of producing a desired type of crop, pharmaceutical,
food product, specific protein. All of these desired
outcomes are worthy of consideration, but in the
interests of justice, safety, and human welfare we will
take a more penetrating look at some individual aspects
of biotechnology in our ongoing series of articles.
Most
of us are under the impression that there is no food
shortage among the 6 million members of the human family
now inhabiting our Earth; even the prospect of an
increase resulting in 10 million humans to feed by the
year 2030 does not arouse concern about potential food
shortages. However, we are certainly aware that there is
a tremendous waste of food due to crop infestation, that
herbicides used to safeguard crops can have negative
side effects upon humans and animals that are exposed to
them. Use of herbicides also increases the prices of
agricultural products.
Genetically
modified crops, that is, crops such as corn into which a
gene for reduction of need for pesticide applications
inserted, namely Bacillus thuringiensis (Bt)
insecticidal protein, does reduce agricultural, worker
and environmental risk. This seems to project no harmful
outcome and indeed is successful and approved by the
Environmental Protection Agency. This particular process
saved the manufacturers $800 million in lost revenue and
$200 million in treatment during 2002. It also resulted
in the planting of this type of corn in Canada, China,
Argentina, and, of course, the United States during
2003.
The
concern in terms of justice over this type of AGBIOTECH
centers around the potential problems of need for
separation of genetically altered crops from non-altered
crops. Some European countries consider biotech foods
and crops dangerous. The history of strange outbreaks of
mad cow disease and discovery of dioxins in chicken feed
there, although not related to GM (genetically modified)
food, make for distrust of all new technologies. And it
is also well known that there have been problems such as
one where a GM crop in the U.S., directed to the
production of animal feed and industry, but not for
human usage, contaminated more than 300 corn products.
This Star Link corn contained an insecticidal
protein, unsafe for humans. Such corn products were
destroyed.
In our next consideration we shall discuss the purposes
of Pharm-Crops, crops which are modified to produce
pharmaceuticals, and consider their advantages and
cautions as we relate them to justice considerations.
“Let us pray for those in high positions in the world
and for all who are called to leadership, that they may
make men’s and women’s lives secure and that they do
not yield to the power of corruption and injustice, but
champion the cause of the poor and the
underprivileged.” (Huis Oosteruis, “Your Word Is Near”)
Biotechnology III
Mary Maier, CSJ
The term “Pharm Farming”
actually has come about for two historical reasons.
The first reason was introduced at the BIO 2003
Conference in Washington, DC on June 25, 2003 by FDA
Commissioner Mark McClellen.
“By some estimates it costs more than $800
million and typically well over a decade to develop a
new drug; by all estimates, the cost of developing safe
and effective new medical products has increased
greatly, more than doubly over the past decade.”
The second reason, presented by Dr. Allan Felsen,
Environmental Toxicologist, describes the vat process
for synthesizing medicines in indoor vats, located in
buildings which cover acres of land plumbed with miles
of pipe. The “brewing” and extraction of medicines takes much
time, much care, and costs an estimated $500 million for
production of one pharmaceutical.
These problems are greatly
diminished by the agricultural technology known as Pharm
Farming, in which a gene designed to produce a
pharmaceutical protein is introduced into a receptive
plant, in other words growing selected plants to produce
specific pharmaceutical protein, e.g. to grow
pharmaceutical corn to produce lipase for the digestive
disorders related to cystic fibrosis.
Crops such as corn, rice, tobacco, and soy are
known to produce proteins with purity and activity
equivalent to those produced by other manufacturing
systems. The
advantages include large volume production capacity,
reduced capital investments, and freedom from potential
viral and animal protein contamination.
Of course, there are complicating
issues surrounding Pharm Farming.
One caution to those involved in growing
pharmaceuticals in open fields can be cited with respect
to the “ProdiGene” incident of October, 2002.
A field in Nebraska was to be used for the
production of
non-pharm soybean; however, the previous crop planted in
that field had been pharmcorn, designed to produce a pig
vaccine. The
500,000 bushels of soybeans from that field and ordinary
corn from a surrounding field had to be destroyed
because of the pharm corn contamination. It is helpful to know that the USDA and FDA
have put stronger regulations in place as a
result of this incident.
In a more general way it is important to note
that approved bio-pharming requires highly skilled
farmers who have to be able to isolate pharm crops, and
there must be testing of pharm crops for allergic
reactions.
There is so much information
related to this topic that it seems apprpriate at this
point to suggest that those interested access http://www.bio.org
and select “Agricultural Production Applications.”
As other highlights of this area develop over
time they will be included in subsequent issues of this
area of biotechnology.
“Let us pray and never cease to ask for
everything we long for, for everything we think we need,
let us pray that God will give it to us.
For food and drink every day, for clothes to
wear, for good health, for a safe journey throughout
life, and for every man and woman a home,” (Huub
Oosterhuis, “Your Word is Near”)
Biotechnology IV
Mary
Maier, CSJ
It is appropriate to
include “Biotechnology” within the issues of justice
because, although the goal of this relatively new
protocol of recombinant DNA technology is the benefit of
humankind, some related issues may bring ethical
questions. For example, the development of this
technology for therapeutic purposes such as a bone
marrow transplant would be in keeping with the goals,
whereas the altering of a human embryo to enhance the
tall-ness or to alter the eye color of the infant would
not be ethical.
In the June 30 edition of “Chemical and
Engineering News” (http://www.cen-online.org) the
importance of “Green Chemistry” was highlighted as
several biotech companies were honored with this
year’s Presidential Green Chemistry Challenge Awards.
Agra-Quest Inc. received an award for its development of
the first broad-spectrum biofungicide, “Serenade”,
non-toxic to garden friendly species and protective of
grapes and tomatoes from fungi. Another awardee company
was DuPont, cited for its development of a biotech
process converting corn-derived glucose to
1,3-propanediol, used in making plastics. It is also
appropriate to recognize Richard Gross at Polytechnic
University, Brooklyn; Dr. Gross received a Green
Chemistry Award for his original biotechnology processes
for producing polyesters.
One aspect of biotechnology which continues
to concern us is the reluctance of some European
countries to accept genetically engineered crops and/or
to engage in biotechnology in the growing of
agricultural products. There is concern over labels: the
European Union demands that all U.S. biotech foods and
products derived from them must be labeled so as to
trace them from the farm to the consumer. Of course,
European countries have limited farmland areas and the
concern that Genetically Modified (GM) crops would
contaminate non-GM crops is a factor in this matter.
Biotech-friendly countries, such as Egypt, Argentina,
and Canada support the U.S. in announcing that a formal
complaint will be registered with the World Trade
Organization about the unfair EU practices. The
Biotechnology Industry Organization urges the EU
Parliament to reexamine its biotech laws with respect to
practicality.
For Americans, who envision the extensive
farmlands of our vast country, the concept of genomics
could ideally solve the starvation problems of
humankind, especially in Africa. However, in countries
such as Malawi, cited in (“Why Famine Persists”, The
New York Times Magazine, July 13, 2003) the tragedy of
starvation is realistically complicated by bad
government, depleted soil, paralyzing debt, and ethnic
and tribal warfare. The article also cites the facts
that “donor nations are now spending considerably less
than a decade ago…the United States spends the lowest
percentage of all”. AGBiotechnology could contribute
to the solution of such tragedies, as noted in the
Chinese experience, where GM crops have already boosted
food and cotton fibre production. Poorest farmers are
provided with free or controlled price GM seed in this
vast country.
Let
us pray for all our fellow men whose pain and misery
come to us every day… and for ourselves that we may
not…live at the expense of others. (Huub
Oosterhuis, “Your Word Is Near”)
Biotechnology V
Mary
Maier, CSJ
It could
alleviate the concerns of those who follow the current
trends of biotechnology to be assured that there are dependable sources of
information to consult. In these articles a web site, http://www.bio.org
has often been recommended; the ‘bio” part of the
address is the abbreviation for “Biotechnology
Industry Organization”, founded in 1993 through a
merger of the Industrial Biotechnology Association and
the Association of Biotechnology Companies. The mission
of BIO centers around advocacy of industry’s
positions, sharing information concerning industry’s
contributions to quality of life, goals, and positions,
and providing business development to member companies.
BIO has grown in membership to more than 1,000
companies, and the hallmark of its success is attendance
at the BIO annual meeting, which has grown from 1,400
registrants in 1993 to 15,673 registrants in 2002.
Ethical concerns are priority items in this
organization; BIO addresses bio-ethics issues at every
level of government.
The “Bioethics Statement of Principles”
available from BIO is supported by the fact that “we
have formed a standing, Board of Directors’-level
committee on bioethics.” It is appropriate at this
point to state that BIO represents biotechnology
companies, academic institutions, state biotechnology
centers and related organizations in the United States
and in many other countries. These members apply
biological knowledge and techniques to develop products
and services for use in health care, agriculture,
environmental remediation. In particular their goals
include saving lives threatened by disease, protecting
blood supplies from infectious agents, improving the
food supply and quality, and cleaning up hazardous
wastes.
This organization has a balanced view of
biotechnology, stating that “biotechnology should not
be viewed as a panacea or as miraculous. For example,
life-saving medicines may have serious side effects
and…expanding knowledge of genetics…can raise
important ethical issues.” Respect for human rights,
dialogue with groups who share an interest in ethical
issues, protection of medical information from misuse,
respect for animals, opposition to cloning of human
beings, promoting sustainable agriculture, development
of environmental biotechnology, opposition to
development of biological weapons, and support for
conservation of biological diversity are ideals
expressed in BIO’s “Bioethics Statement of
Principles.”
It is obvious to us that the word
“biotechnology” has many interpretations, so we must
continue to examine this topic with a view to the
justice involved in its applications to a variety of
circumstances. We recognize that this new technology
should be approached with an appropriate mixture of
enthusiasm, caution and humility. “You are the God of
our fathers…bless our hands and minds so that we do
not build a world that is alien to you.” (Huib
Oosterhuis, “Your Word Is Near”)
Biotechnology
VI
Mary Maier, CSJ
We approach the
topic of biotechnology as it relates to health care
applications with care and the expectation that there
are many aspects of this application of technology which
must be viewed within the context of ethical
considerations. It has been stated (June 23, 2003 at the
BIO Opening Session on Global Health) that “despite
the tremendous progress on medical care in recent
decades, the potential medical benefit of biotechnology
is the main reason why most medical experts believe that
the most important innovations are still ahead of us”.
From our own contact with pharmaceutical corporations
such as Pfizer, Inc. we learn that a traditionally
developed drug requires at least seven years for
research and testing before it can be judged appropriate
for marketing. Obviously this scenario contributes to
the costs for development of new drugs, estimated at
more than $800 million for each new medical product. And
subsequent investigative trials and clinical testing
result, on average, to the fact that less than half of
new medicines lead to FDA approval.
Of course there are government policies
which must be considered to alleviate the above
problems, policies related to the funding of Medicare,
innovative health care, comprehensive drug coverage for
low-income persons, and provision of flexibility of
price controls and regulatory controls. In the context
of biotechnology, integration of biologic therapeutics
into mainstream medical care, advances in blood
technologies, and development of drugs with fewer side
effects are among the desired effects.
Let us now select some of the
characteristics of health-care applications that have
opened as a result of biotechnology. The human body is
so complicated that the availability to employ a method
for discerning a molecular basis of health and disease
can lead to quicker and more accurate diagnostic tests.
Biotechnology can also make possible the elucidation of
therapies with fewer side effects because they are based
upon the body’s self-healing capabilities. Diagnostic
tools which have no biological component, such as
earlier home pregnancy or strep throat tests, provided
less accurate or less immediate results than
biotech-based diagnostics.
In general we can state that biotech-based
diagnostics are cheaper, more accurate and quicker than
previous tests, allowing for earlier diagnosis, thus
improving the patient’s prognosis. Researchers into
the proteomics area are discovering molecular markers
that indicate oncoming diseases before visible cell
changes or disease symptoms appear: one might state that
some tests can detect these biomarkers before the
disease begins. Several future “Issues” will
continue this extensive and health-related topic.
“And let us pray that we may do what is
right…not fail our fellow men and women to further our
own advantage..” (Huub Oosterhuis, “Your Word Is
Near”)
Biotechnology
VII
Mary
Maier, CSJ
In science the word “serendipity” has often been
applied to the phenomenon of the
discovery of some new piece of information which fits
into a line of research which serves to provide for
great progress in a ‘cutting edge’ area of the
quest. The next step in the ongoing series on
biotechnology in medicine in this segment, directed to
the role of the Human Genome Project connection, met
with a serendipitous boost in the 20 June 2003 issue of
“Science”, www.sciencemag.org,
with the news that a team of scientists will lead in a
newly funded Broad Institute “to design genetic tool
kits for use in the fight against cancer, diabetes, and
infectious and inflammatory diseases, to transform
genetic research into clinical medicine.”
The wealth of genomics information made
available Human Genome Project will greatly assist
doctors in the early diagnosis of hereditary diseases,
such as cystic fibrosis and Parkinson’s disease and
genetic tests can identify persons with a propensity to
diseases, including various cancers, asthma and many
more. Early diagnosis can give patients opportunities to
prevent such diseases by avoiding harmful diets,
smoking, and other factors which lead to disease. These
scenarios would connect with biotechnology in the use of
biotechnology-based diagnostic tests, which can range
from simple color-change methods to biotechnology
detection tests, such as those which can screen donated
blood for pathogens that cause AIDS and
hepatitis.
In the vast area of therapeutics,
biotechnology provides FDA approved versions of earlier
drugs to treat diseases such as rheumatoid arthritis,
leukemia, and hepatitis. Other biotech therapeutics are
derived from natural substances from plants and animals.
In this category we can cite the familiar antibiotics;
it is also informative to note that the new technologies
of recombinant DNA and cellular cloning enable
biotechnologists to tap into nature to obtain
anticoagulants, antioxidants preventing tumor growth,
and natural products which can heal wounds. Even shells
from shrimp and crabs can become sources of
drug-delivery protocols.
We might pause at this point and ask why
this biotechnology ‘fad’ in medicine has come to
engender all of this activity. It turns out that these
medical biopolymers are more compatible with our
tissues, that our bodies can absorb them safely after
usage, and that they are superior to non-bio medical
devices or delivery systems. For example, gauze-like
mats made of long threads of fibrinogen, which triggers
blood clotting, can be used to stop bleeding in
emergencies. Adhesive proteins from living organisms are
replacing sutures and staples for closing wounds; once
utilized, they are absorbed into the body.
As the article cited from “Science”
above declares, as The Broad Institute embarks upon its
ambitious effort, “This is biology for the next
generation – and we could serve as the Pied
Piper.”
“For those who lack the most vital
necessities we would like to pray. For health for those
who are ill.” (Huib Oosterhuis, “Your Word Is
Near”)
ISSUES
OF JUSTICE:
BIOTECHNOLOGY VIII
Mary
Maier, CSJ
Gene therapy, another recent focus for
biotechnology, has as its ideal outcome the ability to
provide the human body with all the proteins that it
requires. We recall that DNA is responsible for our
genetic makeup. DNA segments (genes) in each cell
nucleus direct the production of RNA, which moves out of
the nucleus to most wonderfully direct the formation of
necessary proteins. If a specific gene is defective, the
related RNA carries an incorrect message out of the
nucleus and a defective protein is formed.
Therefore gene therapy has traditionally
made use of several techniques to treat genetic
diseases. One such protocol involves the use of
injections of non-defective genes to correct the defect
and thus allow the body to make its own correct
proteins. Some disorders, such as Huntington’s
disease, are not amenable to the replacement gene
therapy above; the best solution in this case is to
treat appropriate cells in these patients with RNA that
interferes with the production of the defective protein.
Recently medical researchers have found
that brief applications of selected genes have been
successful in patients with certain non-hereditary
genetic disorders such as cancers, chronic heart
failures, and AIDS. Even the use of cell transplants
from one (appropriate) organ donor have been helpful for
patients waiting for liver transplants, relief of
pancreatic and cardiac muscle problems. Many of these
protocols require cell encapsulation to keep the
recipients’ immune systems from attacking the donated
cells.
So, you say, where is biotechnology in this
scenario? Our sources remind us that the immune system
fights a variety of diseases subdivided into
“branches”; some branches lack the “troops” to
handle the fight. Biotechnology makes it possible to
produce such necessary “troops”, proteins known as
interferons and interleukins, in sufficient quanti-
ties. Small doses of biotech interleukin-2 is now
effective against AIDS and various cancers; biotech
interleukin-12 shows promise versus malaria and
tuberculosis. Biotech cancer vaccines, given after the
patient has contracted the disease, intensify the
reactions which help the immune system find and kill
tumors.
Persons afflicted with organ-transplant
rejections and auto-immune diseases are in need of
therapeutics which suppress the types of cell in the
immune system responsible for these diseases, such as
rheumatoid arthritis and multiple sclerosis. It has been
found that patients given the biotechnology-based
therapeutic show significantly less transplant rejection
than those patients given cyclosporin. Recent biotech
research has also centered around therapeutic compounds
which can decrease the body’s production of cytokines
of the type which cause chronic inflammation, as
experienced by persons with ulcerative colitis. Even
organ transplants from donors such as pigs and other
animals can be safe-guarded from rejection by the human
recipient by way of a biotech process in which human
genetic material is added in order to disguise the pig
cells as human cells.
“We are the work of your hands, O
God…All our life is your gift..” (Huub Oosterhuis,
“Your Word Is Near”)
ISSUES OF
BIOTECHNOLOGY:
Ethics:
Part I
Mary Maier, CSJ
Because we intend to describe
some therapies which require embryonic stem cell usage,
this is an appropriate time to present the ethical
considerations of biotechnology
overall.
We recall from our first look
at biotechnology that the 1973 experiments which
resulted in the implantation of DNA from a selected
tissue into the plasmids of simple bacteria led to such
breakthroughs as the production of human insulin by
these bacteria. This technique was the early application
of what is more widely known as recombinant DNA
technology.
At that time all of the American scientists
working on this revolutionary process agreed to halt
their research even though they recognized its potential
for good. They were uncertain about some of the
experimental risks and requested that foreign scientists
halt their research also. Later in 1973 communication
with the National Institutes of Health, endorsed by the
National Academy of Sciences, requested that an advisory
committee be established by the NIH to evaluate the
risks of this new technology. After other safety-related
steps were examined by 150 scientists from 13 countries,
a consensus was reached that the scientific community
could proceed with this recombinant DNA technology.
It is remarked in the “Ethics” Guide to
Biotechnology from BIO that, “At no other time has the
international scientific community voluntarily ceased
the pursuit of knowledge before any problems occurred,
imposed regulations on itself and been so open to the
public.”
Let us at this point accept the outcome of
many years of careful regulation of this new
revolutionary technology, which essentially has as its
purpose the improvement of the quality of life for all
persons on our planet. As we approach a discussion of
specific ethical issues, we keep in mind the statement
of the Biotechnology Industry Organization, “we
recognize that the new technology should be approached
with an appropriate mixture of enthusiasm, caution, and
humility.”
For this segment of the ethics discussion
we select the ongoing use of
biotechnology to detect, diagnose, prevent or
treat victims of future biological attacks as well as
the potential for misuse of the technology. To these
ends, appropriate uses of biotechnology include the
research, development, and commercialization of products
and services to detect, diagnose, protect, and treat all
people against harmful pathogens and other agents.
Plans for development of these goals have
been implemented in a limited way at this point in time,
but we can say that “through biotechnology more than
100 new breakthrough pharmaceuticals, vaccines, and
other technologies have helped millions of people
worldwide.” The stated goal of improving the lives of
people necessitates the caution that no biotechnology
applications be used for weapons or as instruments of
harm. “Let us pray for all those, throughout the
world…that they may grow in grace and humanity…may
receive the spirit of Jesus, our Lord.” (Oosterhuis,
“Your Word Is Near”)
ISSUES
OF JUSTICE: BIOTECHNOLOGY:
Ethics
II
Mary Maier, CSJ
Within
the wide variety of social and ethical issues associated
with biotechnology in terms of research, product
development, and commercialization, the issue of gene
therapy has been and is subject to great scrutiny. Only
recently the human genome has been ‘translated’ from
our DNA into information about that which identifies the
human, with 23 pairs of chromosomes in each somatic
cell, and thousands of genes in each chromosome. When
one or more of these 100,000 human genes is defective,
genetic disorders such as cystic fibrosis can result.
The field of gene therapy at this time
places its focus on patients with severe and
life-threatening diseases when other options are not
available or available therapies have not been
successful. In that respect thousands of patients have
heretofore received gene therapy in the battle against
genetic diseases, cancer and AIDS. The usage of gene
therapy has been very gradual because much of the
research in this area is still in early-phase studies.
It is an awesome responsibility to change any person’s
DNA, and the safety of using an agent to carry new DNA
into a cell requires careful research. Much of the
research has focused upon exploring options for routes
for DNA administration, dosing regimes, combination
therapies, and DNA carriers or vectors.
The germ-line cells, namely the egg and the
sperm, have been subject to a voluntary moratorium on
gene therapy procedures by academic and industrial
communities for more than ten years. In a document
entitled “Bioethics Statement of Principles”, this
statement appears, “We are sensitive to and
considerate of the ethical and social issues regarding
genetic research. We will not, for example, treat
genetic disorders by altering the genes of human sperm
or eggs until the medical, ethical and social issues
that will arise from this kind of therapy have been more
broadly discussed and clarified. Also, we support
continuation of the voluntary moratorium on the
potential cloning of entire human beings, with the
understanding that research should continue only on the
cloning of genes and cells to benefit mankind.”
In the International Biotechnology
Convention of Church and Biotechnology leaders on June
25, 2003, both organizations agreed to promote “an
active and informed debate about ethical and moral
implications of the use of various biotechnologies”.
They also committed themselves to promote a
deeper public understanding of ethical issues
surrounding biotechnology. They agreed that, although
biotechnologies promise great contributions to human
well-being, there is a need for vigilance about the ways
in which those technologies are applied. They also
recorded their unequivocal opposition to human cloning.
It is good for us to know that the millions
of persons employed by the international Biotechnology
Industry Organization and the more than fifty million
members of the National Council of Churches, through
their representatives, are committed to the goals cited
in their official report. “Let us pray that we may
care for and respect each other, that we may with one
mind try to achieve happiness”(Oosterhuis, “Your
Word Is Near”)
ISSUES
OF JUSTICE: BIOTECHNOLOGY:
Ethics:
III
Mary Maier, CSJ
At this point in the discussion about gene
therapy, one might be inclined to ask about the
procedures employed to accomplish the replacement or
correction of defective genes.
In general we could state that, because it is now
possible to know the molecular basis for health and
disease, biotechnology provides therapies with fewer
side effects because these therapies are based upon the
body’s capability for self-healing and upon the
availability of newer and safer vaccines.
In an earlier segment of this series we
stated that biotechnology-based diagnostic tools have
made it possible to detect many diseases and medical
problems with greater accuracy and sensitivity than
conventional procedures. For example, tests for strep
throat and other infectious diseases provide results so
quickly that treatment can begin immediately if such
tests are positive. We can add that biotechnology is
allowing for detection of diseases earlier in the
disease process than is possible in more conventional
methods. Research into human protein structure now
provides molecular markers which can indicate incipient
diseases before disease symptoms appear.
The Human Genome Project, completed in
2001, has made it possible for doctors to detect genetic
abnormalities and to provide early diagnosis for
hereditary diseases such as type I diabetes, cystic
fibrosis, early-onset Alzheimer’s and Parkinson’s
diseases. The subtlety of biotechnology testing can also
identify potential victims of various cancers,
osteoporosis, emphysema, type II diabetes, and asthma.
Such information can alert potential patients to avoid
lifestyles which can trigger these illnesses.
The use of genes to treat diseases, gene
therapy, employs molecules such as RNA containing a
non-defective gene to substitute for a defective
inherited gene. This RNA molecule would transcribe to
supply the correct protein needed by the patient. This
is known as replacement gene therapy, can be used for
specific diseases, and makes it unnecessary for patients
to receive daily injections of the correct protein.
Other diseases, such as hemophilia and
severe immune deficiency disease (remember the ‘bubble
boy’) receive “replacement gene therapy” where
genes missing in the patient are administered to the
patient. In some illnesses such as Huntington disease,
the patient’s RNA produces an unnecessary defective
protein, so the administered RNA interferes with the
defective gene production. It has been found that gene
therapy can also be used to treat diseases other than
inherited genetic disorders. This process carefully
introduces transient genes as therapeutics to battle
against a variety of cancers, chronic heart failure,
autoimmune disease, disorders of the nervous system and
AIDS.
It should be thankfully noted that most of
the health problems listed here have been treated
successfully by way of gene therapy. Other health
related biotechnology protocols will be introduced in
subsequent “Issues of Justice: Biotechnology”.
“Heal us and raise us up, O God, for the sake of your
mercy and of Jesus, our brother.” (Huub Oosterhuis,
“Your Word Is Near”)
CURRENT ISSUES
OF BIOTECHNOLOGY
Mary Maier, CSJ
This
source of input concerning BIOTECHNOLOGY has been
unproductive for a few months, but the issues of
biotechnology are more numerous and important than ever.
As a sample of what is cited on line by the
Biotechnological Industry Organization, earlier
referenced as http://www.bio.org
and now announcing the first-ever “World Congress on
Industrial and Biotechnology and Bioprocessing, April
21-23, 2004, a perusal of the topics to be addressed
follows.
Thirty-four
program sessions spotlight the following:
·
Using agricultural crops and biomass to
create new consumer goods and to produce bioethanol
(often mixed with gasoline for vehicle ‘gas’);
·
Fine chemical and pharmaceutical
applications;
·
Applying industrial biotech to produce
bioplastics from agricultural feedstocks;
·
New developments in marine biotechnology;
·
Biotechnology’s positive impact on
climate change and environmental emissions;
·
Innovative pulp and paper applications;
·
New chemical production platforms;
·
The nanotech-biotech interface, related to
the research involving extremely small particles;
·
National defense applications.
It is
appropriate to highlight the scope of the Biotechnology
Industrial Organization as it represents more than 1,000
biotechnology companies, academic institutions, state
techno- logy centers in all 50 of the United States
and 33 other nations. These quotes from the web site are
included now as we acknowledge the fact that
biotechnology is here…now...and that there is indeed
an Industrial Revolution in progress in this world of
2004. Since we are part of this biotechnological
world, we might also wish to explore the “Coalition
for the Advancement of Medical Research: Fast
Action!”, found on line at the site
http://www.camradvocacy.org/fastaction/news.asp?id=787.
Even “Science News” a weekly magazine which is
available in many secondary schools and colleges, is now
in the biotechnology mix as its March 6 and 13 issues
contain articles which focus upon one area of
biotechnology, namely, stem cell research and
applications. The web site is www.sciencenews.org.
As we
attempt to investigate the promising and yet ethically
delicate area of scientific advancement, we must be
aware that there are already programs to train students
for careers in the science and business of
biotechnology, even students on the secondary level. A
text, “Biotechnology: Science for the New
Millennium” is already available and being field
tested in 30 high schools, www.BiotechEd.com.
“God,
do not let us be caught in a web of confusion, but send
us your light and your faithfulness…your care for this
world.” (Oosterhuis, “Your Word Is Near”)
CURRENT ISSUES OF BIOTECHNOLOGY
<<< Therapeutic Cloning
Stem
Cell Research
Mary Maier, CSJ
It is time to address the topic
of stem cells, which are featured in every article
dealing with biotechnology now, in 2004. The word
“cloning” immediately brings to mind the replacement
of the genetic material in an egg cell in order to
insert genetic material from a ‘desired’ source to
produce an offspring of a certain type. Years ago there
was a movie in which the political leader of a country
died, and his cohorts did not wish anyone to know about
this, so they used some nose cells from the recently
deceased and cloned a new look-alike head of state. Of
course, this was just a farce, but it is indicative of
the fact that the idea of producing specific types of
individuals, sometimes referred to as “playing God”
has been around for a long time.
Therapeutic
cloning, however, has nothing to do with reproductive
cloning. The objective of therapeutic cloning is that of
saving lives, not of creating people. It has in broad
terms the offering of great promise for curing terrible
and deadly diseases. In scientific terms it is described
as somatic cell nuclear transfer, transplanting of a
patient’s DNA into an unfertilized egg in order to
grow stem cells that could cure devastating diseases.
The pro-mise of this therapy is that the patient’s
body would accept these cells after implantation because
the patient’s own genetic material is causing cell
reproduction and organ repair.
An
example will be appropriate. Suppose a middle-aged man
suffers a serious heart attack while hiking in a remote
area. By the time he reaches a hospital, only a third of
his heart is still working, and it is unlikely that he
will be able to return to his formally active life. He
provides scientists with a small sample of skin cells.
Technicians remove the genetic material from the cells
and inject his genetic material into donated human eggs
from which the chromosomes have been removed. These
altered eggs will yield stem cells that are able to form
heart muscle cells. Since they are a perfect match for
the patient, these cells can be transplanted into his
heart without causing his immune system to reject them.
They grow and replace the cells lost during the heart
attack, returning him to health and strength. (The above
example is quoted from “Value of Therapeutic
Cloning”, 2/26/04
, http://www.bio.org/bioethics/tcloning.asp.)
Since
the topic of “stem
cells” requires more than casual treatment, the
following issue of this series will be devoted to this
topic. At this time it is appropriate to state that
therapeutic cloning is often called “somatic cell
nuclear transfer”, SCNT. Undifferentiated cells that
are genetically identical to the patient have remarkable
therapeutic potential. Placed in the proper
environments, these cells could even develop into new
tissues, replacing diseased tissues. It is projected
that this process could result in cures of diseases such
as diabetes, so rampant in our country, Parkinson’s
and Alzheimer’s diseases, and some types of
cancer…as well as providing healthy tissue for victims
of burns, spinal and brain injuries. We pray that the
promise of this technology may be fulfilled.
CURRENT ISSUES OF BIOTECHNOLOGY
Ψ
Therapeutic Cloning
Ψ
Mary Maier, CSJ
On
October 28, 2003
, the New York Academy of Science hosted a symposium
titled “Stem Cell Technology: Emerging Science,
Therapeutic Potential, Challenges Ahead.” It brought
into focus the challenges, the promise of both embryonic
and adult stem cells. On
March 6, 2004
, “Science News”, a weekly magazine which reaches
high school and adult students contained “Body
Builders, Using stem cells to cultivate organs”. On
May 12, 2004
, “Science News” featured “Born to Heal: Screening
embryos to treat siblings raises hopes, dilemmas”. It
is obviously time to open this window of opportunity for
many who are in need of what may be called “self
repair.
Let us
understand that there are essentially two types of stem
cells: embryonic and adult. Embryonic stem cells have
the most promise for treating diseases because they can
grow and divide into any type cell, from fetus to adult
cells. Scientists are able to collect these cells when
the embryo is called a blastocyst with very few cells in
a fluid-filled sack. The use of these embryonic cells is
opposed by those who equate this with abortion; however,
cells removed from the umbilical cord later are not
identified with abortion. Adult stem cells may provide
many of the advantages as in embryonic cells, without
ethical concerns.
Adult
stem cells from bone marrow have been effective in
correcting a damaged blood supply; they have also been
known to differentiate into epithelial cells of the
liver, kidney, lung, skin, GI tract, and muscles for the
heart. Some researchers have found that (adult) bone
marrow stem cells have the potential to differentiate
into lung cells and liver cells. Some reservation exists
about the potential success of all of these adult stem
cell findings, because there have been problems with
fusion between the host cells and the donated cells.
However, this is a very hopeful area of research, and
the fact that there are no potential ethical problems
connected to use of adult stem cells provides stimulus
for continued research in this area.
From the March 6, 2004
issue of “Science News”, www.sciencenews.org,
the practical point is made that repair of some damaged
tissues such as the spinal cord is enhanced by mixing
the stem cells with polymer materials which can support
the target tissue as a sort of scaffold.
Three-dimensional polymer scaffolds have enhanced the
rate and success of
“body building”. The reference, “Born To
Heal” highlights applications of stem cell technology
to deal with children who are victims of genetic
disease. The procedure consists of in vitro
fertilization to create several embryos followed by the
selection and implantation in the womb of a selected
healthy embryo. After the healthy child is born, cells
from the umbilical cord are transplanted into the
earlier born unhealthy sibling who then gradually
recovers from the disorder,
in this case, thalassemia, a genetic disorder.
It
should be stated that the National Bioethics Advisory
Commission and other govern-ment agencies have oversight
in many of the processes discussed in these articles.
“Let
us pray for a vital and humane society, for mutual trust
and solidarity whenever men and women work together, and
for honesty in all transactions.” (Oosterhuis: Your
Word Is Near
CURRENT
ISSUES OF BIOTECHNOLOGY
Ш
Therapeutic Cloning Explained
Ш
Mary Maier, CSJ
As
biotechnology becomes increasingly focused upon the
science of stem cell research, the promise of its great
potential to yield revolutionary treatments which
afflict many per-sons has captured the imagination of
the research community, patient advocates, and the
public at large. It is appropriate for this era of
medical innovation that correct information be available
to all who wish to react with integrity to this new
aspect of biotechnology.
For
readers who have not had the opportunity to investigate
the moral and clinical issues of this new technology, it
is appropriate to present some of the basic facts which
are made available from respected sources. When a human
female produces an egg cell which is met by sperm within
a day or two after ovulation, and the fertilized egg,
now dividing, travels to the uterus, the cluster of
cells becomes a nearly hollow globe of 150 cells, the
blastocyst. This cluster of undifferentiated cells is
composed of stem cells. Although many succeeding cells
begin to differentiate after the next three weeks of
pregnancy into nerve cells, etcetera, stem cells are
still present; additionally the umbilical cord contains
undifferentiated stem cells.
In the
current research related to stem cell usage for body
repair and cure of various diseases, a technique called
“somatic cell nuclear transfer”, unfertilized and
enucleated human egg cells receive nuclei transferred
from the potential patient. By using the patient’s own
DNA, the stem cell line would be fully compatible and
would not be rejected when the resulting stem cells are
transferred back to that patient. The umbilical cord
stem cells also become available after a normal
pregnancy comes to completion with the birth of the
baby. It
should also be stated that “adult stem cells” are
available within a few years of birth. For example,
doctors used blood stem cells from a 16-year-old boy to
repair his heart following an accident that had
punctured his heart. Stem cells can also be extracted
from bone marrow without causing the death of the donor.
More precisely, when an adult stem cell receives a cue
to differentiate, it divides into two cells: one which
differentiates and the other remaining undifferentiated
for future purposes of body repair.
It is
important to know that each source of stem cells in the
adult body has its specialized applications. Bone marrow
contains stem cells which differentiate into any of the
types of cells found in blood; liver stem cells can
become any of the specialized cells of the liver.
However, current preference given to the use of human embryonic
stem cells derives from the fact that these cells can
become any kind of cell in the human body. Another
reason for preference of embryonic stem cells in stem
cell therapy and tissue engineering is based upon the
current reality that even fertilized eggs which have
been frozen for possible use by some couples and never
implanted to produce offspring could furnish stem cells
for the pluripotent procedures anticipated by
researchers.
The
ethical and religious considerations of allowing
research to derive stem cells from embryos have prompted
the federal government to refrain from sponsoring such
research. However, in a legal decision, the general
counsel of the Department of Health and Human Services
stated, “The statutory prohibition on the use of funds
appropriated to HHS for human embryo research would not
apply to research utilizing human pluripotent stem cells
because such cells are not a human embryo within the
statutory definition.”
In these
articles the position of the Biotechnology Industrial
Organization (BIO) has been a frequent source of
information. At this time BIO has not endorsed the HHS
position, and although members welcome increased
activity in this area, they “believe that the federal
government can and should determine the appropriate
safeguards to address the ethical concerns of federal
funding of stem cell research.”
“Do
not let us continue, God, to rely on our own powers and
do not allow us to follow the wrong path, but let your
Spirit have power over us and put us on the path that
leads to peace.” (Oosterhuis, “Your Word Is Near”)
Health Care
Clara Santoro, CSJ
The United States is one of the
wealthiest nations in the world, and we have the latest
health care technology. People from other nations come
here to get treatment not available in their own
countries. Yet approximately 41 million Americans lack
medical coverage. Managed care is now a given and HMOs
are increasingly operating on a for-profit mode.
Employers are increasingly shifting rising costs to
workers who are struggling to pay higher premiums,
deductibles and co-payments. Americans who are covered
by Medicaid and Medicare are threatened by a political
ideology that would alter those systems in favor of
privatization.
Of the 41.2 million uninsured, the September
2002 Census Report listed the following:
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