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inherited immune deficiencies. These diseases

regulator), is embedded in the membranes of

were chosen because the mutant gene causing the

several cell types in the body, where it serves

disease was known and there was evidence that

as a channel, transporting chloride ions out

even a few corrected cells could restore complete

of the cells. In CF patients, depending on the

immune function. Since 2000, 37 children

particular mutation the individual carries, the

with either X-linked severe combined immune

CFTR protein may be reduced or missing from

deficiency (X-SCID, the “Bubble Boy Disease”) or

the cell membrane or it may be present but

ADA-SCID (deficiency of the adenosine deaminase

not functioning properly. In some mutations,

enzyme that prevents the correct development

synthesis of CFTR protein is interrupted, and the

and functioning of T-lymphocytes) have been

cells produce no CFTR molecules at all.

treated with this approach. Bone marrow cells

from these patients were exposed to a virus

Although all the mutations associated with CF

containing a normal copy of the mutant gene and

impair chloride transport, the consequences

were then transplanted back into the patients.

for patients with different mutations vary. For

To date, 33 of these 37 patients (89 percent) have

example, patients with mutations causing absent

been cured. Two patients had very low rates of

or markedly reduced CFTR protein levels may

gene transfer, one patient failed the bone marrow

have more severe disease than patients with

transplant, and one patient died of an adverse

mutations in which CFTR is present but has

event related to the gene therapy. In comparison,

altered function. The different mutations also

the best conventional therapy for SCID is bone

suggest different treatment strategies. For example,

marrow transplantation from a compatible donor.

the most common CF-related mutation (called delta

If compatible bone marrow donors had been

F508) leads to the production of protein molecules

available for these patients, only 65 percent

(called delta F508 CFTR) that are misprocessed

would be expected to survive, so gene therapy

and degraded prematurely, before they reach the

is the treatment of choice for these diseases.

cell membrane. This finding suggests that drug

treatments that would enhance transport of the

Cancer presents a complicated problem for any

CFTR protein to the cell membrane or prevent

treatment because the exact mutation causing

its degradation could yield important benefits

the disease is not usually known and therapies

for patients with delta F508 CFTR. Such drug

can injure the healthy cells surrounding the

strategies have been vigorously pursued by the

tumor. Gene therapy is being used to treat a

Cystic Fibrosis Foundation, leading to clinical

variety of cancers, however. One successful

trials of compounds that both assist protein

strategy is to use gene therapy to modify the

processing and encourage proper functioning of

body’s white blood cells so that they become

CFTR once it reaches the membrane.

efficient killers of tumor cells. In one study,

26

patients with malignant lymphomas that had

inception of the HGP, required more than eight

been resistant to all other therapies were treated

years and $50 million. In contrast, now that the

with gene-modified white blood cells. More

HGP is completed, finding a gene associated with

than three-quarters of the patients responded to

a Mendelian disorder can be accomplished in just

the treatment, and 41 percent were completely

weeks at a cost of less than $10,000.

cured of the disease. In another study, genetic

modifications were able to direct white blood

Over the past few years, research into human

cells to another type of cancer: neuroblastoma,

genetic variation has made the dramatic transition

a common childhood cancer with no effective

from focusing primarily on genes associated with

treatment. The neuroblastoma tumors shrank or

single-gene disorders, which are relatively rare

disappeared in half the patients. Because of the

in the human population, to focusing on genes

specificity of these anticancer cells, there were

associated with common multifactorial diseases.

no significant side effects. All told, more than

Because these diseases are not rare, we can expect

1,000 patients have participated in cancer gene

that this work will affect many more people.

therapy studies, and none of them has died as

Understanding the genetic and environmental

a consequence of the gene therapy. Because of

bases for these multifactorial diseases will also

the success of these studies, gene therapy is now

lead to increased testing and the development

being used earlier in the treatment of cancer,

of new interventions that will likely have an

when the prospects for a cure are better.

enormous effect on the practice of medicine

in the next century.

Gene therapy is being developed for many other

diseases as well. Dogs have been cured of all

Genetics, Ethics, and Society

these diseases by gene therapy:

What are the implications of using our growing

• hemophilia,

knowledge of human genetic variation to improve

• several enzyme deficiencies that slowly kill

personal and public health? As noted earlier, the

brain and muscle cells because they store

rapid pace of the discovery of genetic factors in

toxic substances,

disease has improved our ability to predict the

• a third immune-deficiency disease, and

risk of disease in asymptomatic individuals. We

• hereditary blindness.

have learned how to prevent the manifestations

of some of these diseases, and we are developing

The success of these animal studies has allowed

the capacity to treat others.

the therapies to be developed for humans with

the same diseases. A recent study of gene

Yet, much remains unknown about the benefits

therapy for hereditary blindness has shown

and risks of building an understanding of

vast improvement in the vision of the treated

human genetic variation at the molecular level.

patients, and it is hoped that this result will

While this information would have the potential

lead to effective gene therapy for other sight

to dramatically improve human health, the

disorders such as glaucoma.

architects of the HGP realized that it would also

raise a number of complex ethical, legal, and

As Figure 6 indicates, the Human Genome

social issues. To anticipate and address these

Project (HGP) has significantly accelerated the

issues, they established in 1990 the Ethical,

pace of both the discovery of human genes and

Legal, and Social Implications (ELSI) program.

the development of new healthcare strategies

This program, perhaps more than any other, has

based on knowledge of a gene’s structure and

focused public attention, as well as the attention

function. The new knowledge and technologies

of educators, on the increasing importance of

that emerged from HGP-related research have

preparing citizens to understand and contribute

also reduced the cost of finding human genes. For

to the ongoing public dialogue related to

example, the search for the gene associated with

advances in genetics.

cystic fibrosis, which ended in 1989, before the

27

Understanding Human Genetic Variation

Human Genetic Variation

Ethics is the study of right and wrong, good and

Second, ethics requires a solid foundation of

bad. It has to do with the actions and character of

information and rigorous interpretation of that

individuals, families, communities, institutions,

information. For example, one must have a solid

and societies. During the past two and one-half

understanding of biology to evaluate the recent

millennia, Western philosophy has developed a

decision by the Icelandic government to create a

variety of powerful methods and a reliable set of

database that will contain extensive genetic and

concepts and technical terms for studying and

medical information about the country’s citizens.

talking about the ethical life. Generally speaking,

Knowledge of science is also needed to discuss

we apply the terms “right” and “good” to those

the ethics of genetic screening or of germ line

actions and qualities that foster the interests of

gene therapy. Ethics is not strictly a theoretical

individuals, families, communities, institutions,

discipline but is concerned in vital ways with

and society. Here, an “interest” refers to a

practical matters.

participant’s share or participation in a situation.

The terms “wrong” or “bad” apply to those

Third, discussions of ethical issues often lead

actions and qualities that impair interests.

to the identification of very different answers

to questions about what is right and wrong

Ethical considerations are complex and

and good and bad. This is especially true in a

multifaceted, and they raise many questions.

society such as our own, which is characterized

Often, there are competing, well-reasoned

by diverse perspectives and values. Consider,

answers to questions about what is right and

for example, the question of whether adolescents

wrong, and good and bad, about an individual’s

should be tested for late-onset genetic conditions.

or a group’s conduct or actions. Typically, these

Genetic-testing centers routinely withhold

answers all involve appeals to values. A value

genetic tests for Huntington disease (HD) from

is something that has significance or worth in

asymptomatic patients under the age of 18. The

a given situation. One of the exciting aspects

rationale is that the condition expresses itself

of any ethics discussion is the variety of ways

later in life and, at present, there is no treatment

the individuals involved assign values to things,

for it. There is not necessarily an immediate,

persons, and states of affairs. Examples of values

physical health benefit for a minor from a specific

that students may appeal to in a discussion

diagnosis based on genetic testing. In addition,

about ethics include autonomy, freedom, privacy,

there is concern about the psychological effects

sanctity of life, religion, protecting another

of knowing that later in life one will get a

from harm, promoting another’s good, justice,

debilitating, life-threatening condition. Teenagers

fairness, relationships, scientific knowledge,

can wait until they are adults to decide what

and technological progress.

and when they would like to know. On the

other hand, some argue that many adolescents

Acknowledging the complex, multifaceted

and young children do have sufficient autonomy

nature of ethical discussions is not to suggest

in consent and decision making and may wish

that “anything goes.” Experts generally agree

to know their future. Others argue that parents

on the following features of ethics. First, ethics

should have the right to have their children

is a process of rational inquiry. It involves

tested because parents make many other

posing clearly formulated questions and seeking

medical decisions on behalf of their children.

well-reasoned answers to those questions.

This example illustrates how the tools of ethics

For example, we can ask questions about an

can bring clarity and rigor to discussions

individual’s right to privacy regarding personal

involving values.

genetic information; we can also ask questions

about the appropriateness of particular uses of

One of the goals of this module is to help

gene therapy. Well-reasoned answers to such

students see how understanding science can

questions constitute arguments. Ethical analysis

help individuals and society make reasoned

and argument, then, result from successful

decisions about issues related to genetics and

ethical inquiry.

health. Lesson 5, Making Decisions in the Face

28

of Uncertainty, presents students with the case of

dysfunction. Ethics provides a framework for

a woman who is concerned that she may carry

identifying and clarifying values and the choices

an altered gene that predisposes her to breast

that flow from these values. But the relationships

and ovarian cancer. The woman is faced with

between scientific information and human

numerous decisions, which students also consider.

choices, and between choices and behaviors,

Thus, the focus of Lesson 5 is prudential decision

are not straightforward. In other words, human

making, which involves the ability to avoid

choice allows individuals to choose against sound

unnecessary risk when it is uncertain whether

knowledge, and choice does not require action.

an event will actually occur. By completing the

lesson, students understand that uncertainty is

Nevertheless, it is increasingly difficult to

often a feature of questions related to genetics

deny the claims of science. We are continually

and health, because our knowledge of genetics is

presented with great amounts of relevant publicly

incomplete and constantly changing. In addition,

accessible scientific and medical knowledge. As a

students see that making decisions about an

consequence, we can think about the relationships

uncertain future is complex. In simple terms,

among knowledge, choice, behavior, and human

students have to ask themselves, “How bad is the

health in the following ways:

outcome and how likely is it to occur?” When

the issues are weighed, different outcomes are

Knowledge (what is known and not known)

possible, depending on one’s estimate of the

+ Choice = Power

incidence of the occurrence and how much

burden one attaches to the risk.

Power + Behavior = Enhanced Human Health

(that is, personal and public health)

Clearly, science and ethics both play important

roles in helping individuals make choices about

One of the goals of this module is to encourage

individual and public health. Science provides

students to think in terms of these relationships,

evidence that can help us understand and

now and as they grow older.

treat human disease, illness, deformity, and

29

Understanding Human Genetic Variation

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Additional Resources

for Teachers

Online Genetics Education Resources

Ge