[Congressional Record Volume 142, Number 94 (Monday, June 24, 1996)]
[Senate]
[Pages S6719-S6726]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS
By Mr. DOMENICI:
S. 1898. A bill to protect the genetic privacy of individuals, and
for other purposes; to the Committee on Labor and Human Resources.
The Genetic Confidentiality and Nondiscrimination Act of 1996
Mr. DOMENICI. Mr. President, I rise today to return a momentous issue
to the forefront. This issue is genetics confidentiality and
nondiscrimination. I am pleased to report that the human
[[Page S6720]]
genome project is proceeding rapidly to map and sequence the entire
complement of human genes. These genes are coded in over 3 billion
molecular building blocks of DNA.
Now, most people--and I must say most Members of the Congress--are
not necessarily aware of the fact that since 1986, our Government has
been involved in an annual program which has reached the size of about
$138 to $140 million a year, which is divided one-third in the
Department of Energy and two-thirds in the National Institutes of
Health. That program spends that money by permitting various major
American institutions to proceed to map certain chromosomes which are
yielding fantastic information regarding diseases of the human species.
One might quickly recognize that if that is going on, it probably is
also going on in the area of animals and in the area of agricultural
products. And, yes, although the genome project is human, because of
its tremendous success it is going on in the other areas also. So, in a
very real sense, believe it or not, while all the discussion of late is
about conventional health care proposals, it is entirely possible, in
fact I believe probable, that within 25 to 40 years the entire delivery
of health care will be built around genetics rather than what we are
doing today. In fact, at certain conferences we have sat around and
thought about what a hospital will probably look like when we have
finally mapped and sequenced the entire chromosome system. It will not
be anything like we have today.
So, in these 3 million molecular building blocks, we are busy
locating the situs within that molecular system of most of the diseases
that impede human progress and have this enormous impact on our well-
being, our health, and thus our prosperity and the joy of living.
Determining this entire code is going to provide scientists and doctors
with a road map. This map will lead them to great discoveries and
breakthroughs, as I have indicated, to prevent suffering and pain of
diseases.
The human genome project stands to be one of humanity's greatest
scientific achievements. Nonetheless, when the human genome was first
brought to my attention in 1986, I recognized that it could catalyze
revolutions, not just in science and medicine, but also in ethics and
in law and society. That is why one will find, as part of the human
genome funding, that there is money set aside specifically to address
the ethical, legal, and social implications of this project.
There is literally a revolution occurring in genomic information,
special information, information about our species, about our bodies,
and, most important, about ourselves. Who should know this information?
Should it be public? Should our doctors, our friends and our families,
our insurers, our employers or even our very selves know every detail
of our genetic blueprint? These are penetrating and provocative
questions, and they are proactive, and they deeply concern many who
know about them. I guarantee the Senate that there will be, with the
passage of each year, more and more people concerned about them as the
ramifications begin to unfold.
I am not one who says that, because of these serious ramifications,
we should stop the progress of knowledge about human disease. But,
obviously, if we do not do this carefully, the abuse could stop this
progress. About that, there can be no doubt, for, if this kind of
information is abused in a country like ours, there may be an enormous
backlash. Frankly, I think that would be a pathetic response to one of
the approaches to wellness with most potential that humankind has ever
seen.
So, this genetic confidentiality and nondiscrimination is a monstrous
issue, and I raise it today not as the first to raise it, for it is
around. Certain Senators--led over time by Senator Hatfield and, of
late, a few others--are rising to the occasion and worrying about it.
The right for each individual to have some control over his or her
most personal and most identifying information is what we are talking
about. Indeed, I could change my name again and again and maybe some
people would no longer be able to identify me, maybe some would, maybe
some wish they could not. However, I can never, never change my genetic
information. It will always be me, and yours will be you. People will
always be able to identify this genetic information that is peculiar to
each of us. Whether it comes from a drop of blood, the back of a
postage stamp where saliva remains, or a pathology specimen, it is the
person from whence the blood, the saliva, or whatever other piece of
our anatomy is put to the pathology test.
So, along with my colleague, Senator Simon, I am today introducing
the Genetic Confidentiality and Nondiscrimination Act of 1996. This is
a comprehensive and defining legislative vehicle. It is, indeed, needed
to bolster the efforts of 19 States that have enacted some kind of
information privacy statutes, as well as five of my colleagues who have
introduced similar legislation, although substantially different. This
bill in no way infringes on those efforts. Genetics privacy is a big
issue, and many groups will have concern about specific provisions.
There is much work to be done. There needs to be much more debate. I am
certain the Chair is aware of that from this discussion thus far. My
staff, as well as others, have worked very hard to craft the very best
bill that we could.
I think from this point on we should not let time lapse. We should
work together and get something done to make sure we do not punish and
penalize the progress of this rather fantastic health research. Again,
this bill is a comprehensive legislative vehicle that will be subject
to exhaustive legislative review processes, with hearings and input
from all sources and all points of view.
So let me briefly describe our bill. First, I send forward a summary
to the desk and ask unanimous consent it be printed in the Record at
the conclusion of my remarks.
The PRESIDING OFFICER. Without objection, it is so ordered.
(See exhibit 1.)
Mr. DOMENICI. The act itself will be known as the Genetic
Confidentiality and Nondiscrimination Act of 1996. First, the bill
defines genetic information as uniquely private and distinct from other
personal information such as medical records. As I mentioned before, it
is impossible to separate one's identity from one's genes. One's DNA
also provides information about one's family. Genetic information
carries significance and has great potential for misuse. Let me repeat.
This information is of special significance and has great potential for
misuse. Genetics transcends medicine and can penetrate many aspects of
life, including employment, insurance, education, forensics, finance,
and even one's self-perception.
Let me also make it perfectly clear that this bill does not make it
illegal for a third party to collect, store, analyze, or even disclose
an individual's genetic information. This bill requires that third
parties obtain the individual's informed and written consent.
This legislation puts individuals in control of his or her genetic
information. Some will object to that, but ultimately the question is
going to be asked: If not the individual, who? Exceptions are provided
in the bill for legitimate medical research, law enforcement
activities, court-ordered analysis and purposes of identification of
dead bodies or active duty military remains and, on the latter, we have
already been hearing something about that.
Specifically, the purposes of this legislation are:
First, to define the circumstances under which genetic information
may be created, stored, analyzed, or disclosed;
Second, to define the rights of individuals with respect to genetic
information;
Third, to identify the responsibilities of third parties with respect
to genetic information;
Fourth, to protect individuals from genetic discrimination with
respect to insurance and employment. Just think of that one, the
opportunity to discriminate because of genetic information if randomly
delivered to people such as insurance carriers, employers, and many
other institutions and individuals that could act based on it.
Fifth, to establish uniform rules to protect genetic privacy and
allow the advancement of research.
Today, there is clear and pressing need for Federal legislation on
this issue. This Senator, along with Senator Simon--and I am sure there
will be others who will join us, but I have just not had enough time to
get this circulated and get it out to other Senators; that will start
today--but we are introducing this bill to motivate, consolidate,
[[Page S6721]]
and strengthen the process of getting something done in this very, very
important area. I look forward to working with my House and Senate
colleagues in bringing this issue, with broad bipartisan support, to an
anxiously awaiting American public.
Mr. President, the call is now. Once again, the human genome project
stands to be one of the greatest scientific and medical achievements of
all time. And incidentally, I think one might wonder why we did not do
this a long time ago. We constantly talk about the computer and what it
permits us to do that we could not have done. It is patent and obvious
that we could never ever have begun the process of mapping the 3
billion human genomes within the chromosome system of a human being
without the computer system that has evolved in our country.
Without that, we would still be having researchers take on and study
for their whole lifetime where the gene for multiple sclerosis might
be. This is not to say many of those great research teams struggled
mightily, and they did, and they found the situs for many of them and
cures and drugs have resulted that ameliorate and sometimes cures.
But this offers science ultimately a map of all of the chromosomes,
and then they will begin to sequence them in some kind of order. They
will have a road map and then start to sequence them.
What they will have done, once they have finished, is give the great
scientists an opportunity to focus in on the work to find where the
mutation is that is causing breast cancer. Work is being done with
families on just that subject, and the mutation is being isolated and
people are being, in some instances, told whether they are going to get
this cancer or not. It is rather amazing.
Where will all this end up? Let us hope, with an appropriate
reservation of rights on disclosure, that it will end up in the right
hands doing the right kind of things, making the right kind of progress
that our great society is taking the lead in. I will say, though, so
nobody thinks this is totally and singularly an American project. It is
not. The French are doing great work. In some cases, they have a lead
on America. Japan is doing some, and almost all of the industrialized
nations are doing some. But our great genome project has moved ahead in
a dramatic manner. It is ahead of schedule, it has cost much less than
we expected and, consequently, it is time for us to do something now
about this aspect of it.
Its wonderful promise may never be fully realized if the public is
afraid of what someone else will do with their information. That is the
reason that this becomes very important.
Mr. President, in addition to the matter for which I asked unanimous
consent earlier, I ask unanimous consent that a number of news articles
be printed in the Record, and I send the bill to the desk and ask for
its appropriate referral.
There being no objection, the articles were ordered to be printed in
the Record, as follows:
Genetic Prophecy and Genetic Privacy--Can We Present the Dream From
Becoming a Nightmare?
(By George J. Annas)
Would you want to know if you're likely to develop
Alzheimer's disease later in life? Would you want your
employer, your health insurer, your colleagues, or your
family to know? Who should decide who should know, and how
can public health practitioners use genetic information on
predisposition to diseases like dementias and cancer for the
public good without stigmatizing individuals?
In this issue's Health Law and Ethics, Mayeux and Schupf
pose all of these questions and more in the context of
apolipoprotein-E screening for Alzheimer's disease. Although
the presence of the 4-type apolipoprotein E allele is not a
test for Alzheimer's disease, Mayeux and Schupf's analysis
suggests many of the issues we will face when tests for the
genes that cause various types of Alzheimer's disease, such
as early onset Alzheimer's, become available. They argue,
persuasively I think, that population screening now ``would
not only be impractical, but would be of no obvious benefit''
and ``without a clear-cut therapeutic option, early detection
(by testing) at this point does not seem beneficial.'' They
also properly stress the dangers of creating disease in the
absence of symptoms, and the necessity for pre- and post-test
counseling for any such probabilistic, presymptomatic genetic
testing.
The central question presented by genetic screening and
testing is whether genetic information is different in kind
from other medical information (such as family history and
cholesterol levels), and if so, whether this means that it
should receive special legal protection. Stated another way,
are Mayeux and Schupf correct in concluding that ``the
genetic code of an individual should be protected and
considered confidential information in all circumstances''? I
think they are, but their conclusion with respect to genetic
privacy deserves more analysis.
Genetic information can be considered uniquely private or
personal information, even more personal than other medical
information such as human immunodeficiency virus (HIV) status
or mental health, for at least three reasons: it can predict
an individual's likely medical future; it divulges personal
information about one's parents, siblings, and children; and
it has a history of being used to stigmatize and victimize
individuals.
The highly personal nature of the information contained in
one's deoxyribonucleic acid (DNA) can be illustrated by
thinking of DNA as containing an individual's coded ``future
diary.'' A diary is perhaps the most personal and private
document a person can create. It contains a person's
innermost thoughts and perceptions and is usually hidden and
locked to assure its secrecy. Diaries describe the past. The
information in one's genetic code can be thought of as a
coded probabilistic future diary because it describes an
important part of a person's unique future and, as such, can
affect and undermine one's view of himself or herself and his
or her life's possibilities. Unlike ordinary diaries that are
created by the writer, the information contained in one's
DNA, which is stable and can be stored for long periods of
time, is largely unknown to the person. Most of the
code cannot now be broken, but parts are being deciphered
almost daily. As decoding techniques get better, and if
one's DNA is deciphered without permission, another person
could learn intimate details of the individuals likely
future life that even the individual does not know.
Deciphering an individual's genetic code also provides the
reader of that code with probabilistic health information
about that individual's family, especially parents, siblings,
and children. Finally, genetic information (and
misinformation) has been used by governments (US) immigration
and sterilization policies and Nazi racial hygiene policies,
for example) to discriminate viciously against those
perceived as genetically unfit and to restrict their
reproductive decisions.
Mayeux and Schupf note my prior recommendations regarding
regulating DNA banks. Although regulating such ``gene banks''
is necessary to protect genetic privacy, it is not
sufficient. My colleagues Leonard Glantz and Patricia Roche
and I now believe that we need federal legislation to protect
individual privacy by protecting not only DNA samples, but
also the genetic information obtained from analyzing DNA
samples. To be effective, such legislation must govern
activities at at least four points: collection of DNA,
analysis of DNA, storage of DNA and information derived from
it, and distribution of DNA samples and information derived
from DNA samples. As a general rule, no collection or
analysis of an individual's DNA should be permitted without
an informed and voluntary authorization by the individual or
his or her legal representative. Research on nonindentifiable
DNA samples need not be inhibited; but research on DNA from
identifiable individuals should proceed only with informed
consent.
To codify these rules and make them uniform throughout the
United States, we have drafted the ``Genetic Privacy Act of
1995,'' the core of which prohibits individuals from
analyzing DNA samples unless they have verified that written
authorization for the analysis has been given by the
individual or his or her representative. The individual
has the right to do the following:
Determine who may collect and analyze DNA;
Determine the purpose for which a DNA sample can be
analyzed;
Know what information can reasonably be expected to be
derived from the genetic analysis;
Order the destruction of DNA samples;
Delegate authority to another party to order the
destruction of the DNA sample after death;
Refuse to permit the use of the DNA sample for research or
commercial activities; and
Inspect and obtain copies of records containing information
derived from genetic analysis of the DNA sample.
A written summary of these principles (and other
requirements under the act) must be supplied to the
individual by the person who collects the DNA sample. The act
requires that the person who holds private genetic
information in the ordinary course of business keep such
information confidential and prohibits the disclosure of
private genetic information unless the individual has
authorized the disclosure in writing, or unless the
disclosure is limited to access by specified researchers for
compiling data. Although the act itself does not prohibit the
use of genetic information by employers and insurance
companies (because this is a separate problem from privacy),
it would be reasonable public policy to prohibit both
employers and health insurance companies from using genetic
information in making hiring and coverage decisions. Congress
should act now to protect genetic privacy. While we
[[Page S6722]]
wait for congressional action, states can act, and private
companies and practitioners can voluntarily adopt these
privacy rules as their own.
The new genetics raises virtually every major health care
policy question, as well as unique legal and ethical
problems. How should screening for BRCA 1 and BRCA 2 (two
``breast cancer genes'') be introduced into medical and
public health practice? Should we prohibit parents from
authorizing the testing of minors or fetuses for breast
cancer genes, or any other gene predisposing to a
nonpreventable, late-onset disease? The Human Genome Project
has devoted approximately $3 million a year for the past 5
years to exploring the legal, ethical, and social policy
issues raised by the project. The Genetic Privacy Act is one
of the products of this funding. In addition, the Institute
of Medicine's Committee on Assessing Genetic Risks has made
more than 225 specific recommendations dealing with genetic
screening and testing, virtually all of which are reasonable.
We know the privacy and policy issues that come with the new
genetics. The challenge is to act now to try to maximize the
good and minimize the harm that will come to all of us from
our new genetic knowledge.
____
[From the Washington Post, May 12, 1996]
This Map Won't Show Us the Way
(By Jessica Mathews)
The job of deciphering the 60,000 to 100,000 genes the
human genome will be finished in less than 10 years. That may
sound like a long time, but it isn't. Long before then, but
it isn't. Long before then, at an accelerating pace, we will
begin to be flooded with genetic information that can be as
treacherous and unwelcome as it sometimes is lifesaving. We
will need every minute to prepare for a revolution in
medicine that will invade our privacy in unprecedented ways
and challenge legal protections, social values, personal
ethics and religious beliefs.
If the past is any measure, we won't be ready. With no
societal consensus about how to approach the issues, most of
the decisions will get bumped, as a last resort, to the
courts where judges with no particular qualification nor
preparation will have to decide, struggling to find some
constitutional basis for resolving novel, moral dilemmas.
Think for a moment about a world in which genetic screening
of people and fetuses is routine.
Suppose you knew you had a high risk of dying in 10 years?
Should it be legal to keep that information to yourself when
buying life insurance?
How would a managed-care provider treat a couple who
refused preventive treatment. (an abortion) for a fetus that
would require lifetime medical care?
What if screening revealed children's individual endowments
of traits were now call intelligence. Would society demand
educational tracking beginning in preschool?
How will prospective parents deal with the information in a
fetal screen? Suppose it reveals a high risk of heart
disease, or mental disorders, or obesity or undesirable
temperament? Will pregnancy in this brave new world
necessarily be a time of achingly difficult decisions? What
will it mean for society when every child enters the world
with hundreds of ``preexisting conditions''? What will it
mean for religion when innate characteristics become a matter
of choice?
Will the rich, who can afford repeated fetal screening and
genetic interventions, begin to produce children who differ
more and more from those of the poor?
Should prospective employers and insurers have access to an
individual's genetic profile? What about prospective spouses?
What about us--would we have a ``right'' not to know about
ourselves?
Will we want all this information we can do very little
about? Will we ever be able to meaningfully apply statistical
risks to our own, individual cases? How will we cope with
decades of enormous uncertainty as scientists sort out the
interactions of tens of thousands of genes and the
interactions of the resulting genetic propensities with the
environment?
Where will we find enough genetic counselors who combine
scientific knowledge, therapeutic insight, clerical
compassion and the wisdom of Solomon? Should they just give
the facts? If they do more, whose values will they be
transmitting?
What about genetic alteration of germ cells, those that
pass on traits to future generations? So have said that a
line can be clearly drawn making these cells off limits. But
suppose it becomes possible to alter the genes that give rise
to familial predispositions to cancer and other diseases.
Wouldn't we want to do that? Then aren't we facing an era of
human eugenics?
The widespread unhappiness with having judges rule on the
moral question of physician-assisted suicide offers a faint
preview of what it would be like to leave such questions to
the courts. In one of those cases, Andrew Kleinfeld, a
dissenting judge on the 9th Circuit, made his own discomfort
plain. ``The Founding Fathers did not establish the U.S. as a
democratic republic,'' he wrote, ``so that elected officials
could decide trivia, while all great questions would be
decided by the judiciary.''
The alternative is to develop sufficient public
understanding to address these choices through referendums
and legislatively and, if possible, to do so in a way that
avoids making genetic ethics into a political football like
abortion. A small beginning has been made. The government-
funded Human Genome Project wisely set aside a small fraction
of its budget to study moral and ethical questions, so there
are expert groups and advisory committees and a stream of
scholarly papers. But that is not enough.
Nor is it enough to vaguely call--as I have in the past--
for a ``broad public conversation'' on the subject. Without
some sort of crisis it just won't happen. What is needed is a
national commission of a new and different kind.
The usual mission for such a body is to serve either
government or interested groups through fact-finding,
research and expert advice. This one's client would be the
public. Its job would be to find innovative ways to inform
and stimulate public debate; to frame choices, to offer
balanced pros and cons; to confront as many Americans as it
can with the facts and the uncertainties and scientists' best
guesses about where their work is leading. It should be
nonpartisan and operate for as long as we need it.
The mapping of the human genome will be an enormous
scientific achievement, at least on a par with nuclear
fission, but much more personal. If it is, on balance, to
improve our lives in the next few decades, we'll have to
collectively think it through--in advance.
____
[From the Washington Post National Weekly Edition, June 3-9, 1996]
All in the Genes--The New Availability of Tests Raises a Host of
Ethical Questions
(By Rick Weiss)
When Ebenezer Scrooge got a sneak preview of his own
demise, including views of his funeral that no one cared to
attend, he had only to change his evil ways to revise the
future. If only genetic testing offered such simple
solutions.
New genetic tests are moving rapidly from research
laboratories into doctors' offices, where they are being
marketed as a way to predict people's chances of getting
common diseases such as colon cancer, breast cancer and
Alzheimer's disease.
But instead of offering clear views of the future and
strategies for altering it, genetic tests have raised the
specters of DNA-based discrimination and loss of health
insurance, and the prospect of people learning just enough to
scare them but not enough to cure them.
Now, as companies begin to market their new tests,
scientists, patients' groups, health insurers and legislators
are rushing to stake out positions on what restrictions, if
any, should be placed on the commercialization and use of
genetic tests. The strained positions some are taking reveal
the extent to which science today is intermingled with
politics and business.
Congress, for example, is preparing legislation that would
prohibit genetic discrimination against some people--but not
against others. The Food and Drug Administration, already on
the defensive amid corporate claims of over-regulation, has
declared it has the authority to regulate genetic tests but
hastens to add that it has no plans to do so. And in perhaps
the most unusual twist, many advocates of patients' rights
who usually clamor for access to the latest cancer
breakthroughs are asking that some genetic tests be kept from
patients.
The National Breast Cancer Coalition, for example, a
patients' rights group, opposes open marketing of a test for
the so-called breast cancer gene, BRCA1. At the risk of
sounding as paternalistic as the doctors they often fight
against, members say the test's generally ambiguous results
may trigger unnecessary panic in many women while reassuring
others who should remain vigliant.
``There's a real dilemma among feminist scholars on this,''
says June Peters, a genetic counselor at the National
Institutes of Health. ``You need to build in safeguards,''
she says, since profit-driven companies do not necessarily
share the same interests as patients. ``At the same time,
there is the feeling, `I am an adult and I can take care of
these decisions myself.' ''
Genetic tests differ from many medical tests because they
often provide very vague answers, such as, ``You have a gene
that gives you a 70 percent chance of getting breast cancer
in the next 20 years.'' That uncertainty can be all the more
frsutrating because in most cases there is nothing a person
can do to prevent the predicted disease from occurring.
Moreover, people can reduce their risk of getting heart
disease or cancer by changing unhealthful habits such as
overeating or smoking, but they are stuck with their genes.
And with legal protections still not fully established, the
information gleaned from genetic tests today is as easily
used against people as for them.
``You can't choose your genes,'' says Francis Collins,
director of the National Center for Human Genome Research.
``So you shouldn't be discriminated against on the basis of
those genes.''
The stakes are high on both sides of the issue. The
fledging genetic testing industry, which foresees soaring
profits in the next few years, is pushing hard to get its
tests to market, arguing that patients have the right to
learn about their own genes even if the information is
incomplete or inconclusive. Similarly, health insurers
desperately want the right to peek at their clients' genes to
help predict their medical fates--and to set their insurance
rates accordingly--in part because they are afraid that
people who discover they have faulty genes may try to take
out large policies.
[[Page S6723]]
On the other hand, many scientists, doctors and patients'
groups argue that, at least for now, most gene testing should
be limited to research studies designed to gather more
information about how to make the most of this new resource.
Studies could keep track of how people with various
``bad'' genes fare over the years, settling the question
of which genetic glitches really matter and which are less
important.
Studies also could compare different preventive treatments
to see whether it is worthwhile, for example, to remove a
person's colon just because a genetic test reveals a very
high risk of colon cancer, or whether that individual can
safely put off surgery until a cancer is actually found.
Extra time also would allow Congress and other institutions
to devise safeguards against the misuse of genetic
information.
With these concerns in mind, several prestigious scientific
organizations--including the American Society for Human
Genetics, the National Advisory Council for Human Genome
Research and the National Action Plan on Breast Cancer, which
is coordinated by the U.S. Public Health Service--have come
out against commercialization of the BRCA1 test, the first
crude predictor of cancer risk to come on the market.
Scores of genetic tests have been developed for dozens of
diseases. Some are used to diagnose existing conditions and
others are used in healthy people to predict the odds that a
disease will occur. The tests, usually done with a drop of
blood, look for ``misspellings'' in a person's DNA--the
strands of genetic material that spell out in biological code
the instructions for making products the body needs.
Many genetic tests--especially those for rare diseases--can
predict with certainty a person's fate. Everyone who tests
positive for the genetic defect associated with Huntingdon's
disease, for example, will get the fatal neurodegenerative
disease, probably in midlife.
But many other genetic tests--especially those for more
common diseases such as cancer and Alzheimer's disease--offer
far less definite predictions. The breast cancer test, which
looks for a spelling error in the BRCA1 gene, is one such
test. It is now making its way onto the market in three
different formats, ranging from ``research only'' to open
marketing.
Increasing numbers of women are asking for the test because
they are under the impression that those who have a mutation
in the BRCA1 gene have an 85 percent chance of getting breast
cancer, as well as an elevated risk of ovarian cancer.
But what should a woman do if she tests positive? No
preventive strategies have been shown to help--not even
preemptive removal of both breasts, since tumors may still
develop in nearby chest tissues. More frequent mammograms to
watch for the first sign of cancer may be useless or even
dangerous, since there is evidence that some women with this
mutation may be especially prone to DNA damage and cancer
from X-rays.
To further complicate the issue, more than 130 mutations
have been found in the breast cancer gene. Some are probably
meaningless, and others deadly, but most have not been
studied yet. Standard gene tests available today detect only
one or a few of the more common mutations, so a negative test
doesn't guarantee safety.
Most important, many women seem not to realize that it is
only if a woman has a clear family history of breast cancer--
usually defined as two or more close relatives with the
disease--that the BRCA1 mutation confers 85 percent odds of
getting breast cancer.
The vast majority of women do not come from cancer-prone
families, and for them the risk of having a BRCA1 mutation
remains completely unknown.
That is not to say the test is useless. For some carefully
selected women already diagnosed with breast cancer, a
positive test can indicate the need for more aggressive
therapy.
And for a woman whose mother or sister had breast cancer
from a BRCA1 mutation, a negative test can provide some
reassurance. What remains unproved, however, is that the test
has any value for the more than 95 percent of women who do
not fit into those categories.
A federally funded study of thousands of women, ongoing in
the Washington, D.C.-Baltimore area, will begin to answer the
question of what a positive BRCA1 test really means. But
because it is research, and the results of the study will
take time to interpret, the women will not be told whether
they have the mutation.
Meanwhile, the Genetics & IVF Institute, of Fairfax, Va.,
recently started offering the BRCA1 test to women willing to
pay about $300. The clinic has been criticized by some
doctors and ethicists for making the test available to women
who might have little or nothing to gain from it. Its medical
director, Joseph Schulman, declined to be interviewed for
this story.
A third option, praised by several doctors as a good
compromise, is underway at OncorMed, of Gaithersburg, Md. The
company offers BRCA1 testing and results to women who are
willing to follow certain rules prepared by an independent
research review board. Women must be referred for
counseling before and after the test is performed. Results
must be given by the doctor in person, and the doctor must
follow up with patient about three months later. The
company also must compile data from its experience to
determine which aspects of the gene-testing process need
improvement.
At a recent meeting in Baltimore of a federal task force on
gene testing, some participants questioned whether the
companies marketing genetic tests should be the ones to
decide who gets tested and what information they receive or
whether some sort of regulatory oversight should be imposed.
The question of oversight is made more difficult because
laboratory testing already is regulated in a patchwork
manner, and none of the patches quite applies to genetic
tests.
Medical testing is regulated in part by an act of Congress,
the Clinical Laboratory Improvement Amendments of 1988. But
CLIA stipulates only that laboratory tests must be
scientifically accurate--that is, a test for a BRCA1 mutation
must be good at finding BRCA1 mutations. It does not require
that a test have any proven usefulness for patients. The FDA
reviews and approves the relatively simple test ``kits'' that
are sold for use in commercial laboratories or at home. At
times it has even required that counseling be given with test
results, as it did with the approval of a home AIDS test
early last month.
But genetic tests are too new and complicated to be sold as
kits. Most genetic tests are ``home brew'' tests, developed
inhouse by the companies that do the testing. The FDA has the
authority to regulate such tests, says Deputy Commissioner
Mary K. Pendergast, but it has never done so. ``We would not
be able to take it on,'' she says, ``without stopping other
things we are doing now.''
Congress could help protect test recipients by making it
illegal for insurers and employers to discriminate on the
basis of genetic information. Both the House and Senate
versions of the health care bill that is soon to be
considered by a conference committee contain language that
would prohibit some forms of genetic discrimination.
The bills would preclude companies from using genetic
information to deny an insured person continued insurance
when that person changes health plans. But they offer little
or no protection to people who do not yet have insurance and
are trying to get it. And other safeguards are far from
complete.
``These bills would require that insurers offer a policy,
but they don't cover pricing, so we can expect to see
discriminatory pricing,'' says Wendy McGoodwin, executive
director of the Council for Responsible Genetics, an advocacy
group in Cambridge, Mass. ``And it has no impact whatsoever
on life insurance or disability insurance.''
According to many experts, the last hope for intelligent
guidance on the gene-testing issue may be a federal task
force convened last year by the National Institutes of Health
and the Department of Energy.
The task force, with representatives from the medical
profession, the testing and insurance industries and
patients' rights groups, is preparing a wide-ranging report
on the ethical, legal and social implications of genetic
testing, due to be completed by the end of the year. But
consensus has been difficult to achieve.
At a task force meeting in April, representatives of the
biotechnology industry said it is the doctor's job to make
sure that patients understand the risks and benefits of being
tested. Doctors said they were still getting up to speed in
genetics and would be unable to stem the tide of patient
demand if testing were not subject to regulatory
restrictions. And insurers said they would go out of business
if they were restricted from having access to genetic
information.
Given the lack of agreement, some suspect the field will
simply grow like any other ``buyer beware'' market as more
and more tests become available.
``Physicians are soon likely to confront extremely awkward
situations,'' Harvard scientists Ruth Hubbard and Richard
Lewontin wrote recently in the New England Journal of
Medicine. ``Physicians need to recognize the limitations of
the new information * * * and the commercial pressures behind
the speed with which preliminary scientific data are being
turned into tests.''
Mr. DOMENICI. I yield the floor.
Exhibit 1
The Genetics Confidentiality and Nondiscrimination Act--Summary
Sec. 1.--Short title: The ``Genetics Confidentiality and
Nondiscrimination Act of 1996''
Sec. 2.--Findings: The DNA molecule contains an
individual's genetic information that is uniquely private and
inseparable from one's identity. Genetic information is being
rapidly sequenced and understood. Genetic information carries
special significance. It provides information about one's
family, and, more importantly, provides information about
one's self and one's self perception. Genetic information has
been misused, harming individuals through stigmatization and
discrimination. The potential for misuse is tremendous as
genetics transcends medicine and has the potential to
penetrate many aspects of life including employment,
insurance, finance, and education. Genetic information should
not be collected. stored, analyzed, nor disclosed without the
individual's authorization. Current legal protections for
genetic information are inadequate. Uniform rules for
collection, storage and use of DNA samples and genetic
information are needed to protect individual privacy and
prevent discrimination, such as in employment and insurance,
while permitting legitimate medical research.
Purposes: This legislation will: (1) define circumstances
under which genetic information may be created, stored,
analyzed, or disclosed: (2) define rights of individuals and
[[Page S6724]]
persons with respect to genetic information; (3) define
responsibilities of others with respect to genetic
information; (4) protect individuals from genetic
discrimination; (5) establish uniform rules that protect
individual genetic privacy and allow the advancement of
genetic research; and (6) establish effective mechanisms to
enforce the rights and responsibilities defined in this Act.
Sec. 3.--Definitions: Genetic information--means any the
information that may derive from an individual or a family
member about genes, gene products, inherited characteristics.
Such term includes DNA sequence information including that
which is derived from the alteration, mutation, or
polymorphism of DNA or the presence or absence of a specific
DNA marker or markers. Individual--means the source of the
DNA sample including body, body parts, or bodily fluids from
whom the DNA sample originated. Research--means systematic
scientific (including social science) investigation that
includes development, testing, and evaluation, designed or
developed to contribute to original generalizable knowledge.
title I.--Collection, storage, and analysis of dna samples
Secs. 101-105 prohibit collection, storage, or analysis of
genetic information, unless written, informed consent has
been obtained from the individual (exceptions in the bill are
provided for identification of dead bodies or active-duty
remains, law enforcement purposes, purposes pursuant to
court-ordered analysis, and some research purposes).
title II--disclosure of genetic information
Secs. 201-205 describe the written authorization necessary
to disclose genetic information. It also describes the
protection, inspection, amendment, and disclosure of records
containing genetic information. This part also provides
exceptions for compulsory disclosure in any judicial,
legislative, administrative proceeding, as well as court-
order purposes. (The bill also provides some exceptions
for research purposes under Title V.)
title III.--Discrimination Prohibited
Secs. 301-302 prohibit genetic discrimination by employers
and insurers.
Title IV.--Exceptions for Identification and Court-Ordered Analysis
Secs. 401-404 provide exceptions for identification of dead
bodies and active-duty military remains, law enforcement
purposes, and activities pursuant to court-ordered analysis.
Title V.--Research Activities
Secs. 501-503 restate the need for researchers to obtain
informed consent from individuals who participate in
research. It provides exceptions for obtaining, storing, and
analyzing genetic information for research purposes. It
specifies: conditions for genetic analysis, safeguards
against disclosures, limitations on minors (requires parental
consent), destruction of DNA samples upon completion of the
project (unless permission is given to maintain them),
protections regarding pedigree analysis and family linkage
studies, and the research subjects' right to obtain
information. This part also specifies conditions for
disclosure of genetic information for research purposes,
allows limited access to genetic information for
epidemiologic uses, and provides exceptions for DNA samples
collected from individuals prior to the effective date of
this Act.
Title VI.--Minors
Sec. 601 provides conditions for collection and analysis of
genetic information from minors. Essentially, the bill
requires a parent, guardian to consent to the individual's
participation in research and that the analysis benefits the
individual.
Title VII.--Miscellaneous
Secs. 701-702 require employers to annually notify
employees who maintain DNA samples or genetic information of
their responsibilities under this Act. It also provides for
continuity of privacy of genetic information upon transfer of
ownership or discontinuation of services.
Title VIII.--Enforcement
Secs. 801-802 provide civil penalties of $50,000 for
negligent violation or $100,000 for willful violation; both
per incident. No criminal penalties are specified. Injunctive
relief and private right of action are also provided. There
is a six year statute of limitations.
Title IX.--Effective Dates, Applicability and Relationships to Other
Laws
Proposed effective date is January 1, 1997. Nineteen States
have enacted genetics privacy or nondiscrimination
legislation; this Act would only serve to strengthen existing
State laws.
______
By Mr. STEVENS (for himself, Mr. Leahy and Mr. Murkowski):
S. 1899. A bill entitled the ``Mollie Beattie Alaska Wilderness Area
Act''; to the Committee on Energy and Natural Resources.
The Mollie Beattie Alaska Wilderness Area Act
Mr. STEVENS. Mr. President, I am here today with a heavy heart to
introduce a bill that I would like to have called the Mollie Beattie
Alaska Wilderness Area Act. My colleague from Alaska, Mr. Murkowski
joins me in my remarks and as an original sponsor of this legislation.
I want to make a few remarks about Mollie, who has served well as the
Director of Fish and Wildlife Service for this administration. I
believe my colleague in the House, Don Young, will introduce similar
legislation. As the Senate knows, Mollie Beattie is gravely ill--so ill
that she decided to step down from her position as Director of the Fish
and Wildlife Service. We are now informed that Mollie's situation is
worsening.
It may seem strange for me to be here talking about Mollie Beattie.
She opposed many of the things that I believe in, as far as Alaska
public lands are concerned. But I am introducing this bill to designate
the 8 million acres of wilderness within the 19 million acre Arctic
National Wildlife Refuge as the ``Mollie Beattie Alaska Wilderness
Area.''
Under my legislation, the Secretary of the Interior would be directed
to place a monument on a portion of the wilderness, so that people
entering the wilderness might remember and honor Mollie Beattie's
contribution to the conservation of fish and wildlife.
Now, Mollie Beattie opposed us on some things, and she worked with us
on some things. But the reason I like her is she was always honest with
us. We knew where she stood. And she listened. As a matter of fact, as
days went on, we thought maybe she was listening to us more and we
might be able to find some middle ground between the position she had
taken and our own.
And so I was saddened, and I came to the floor and said so, when
Mollie stepped down from her position as the Director of the Fish and
Wildlife Service. In Mollie's departure from the Service, the American
people are losing a leader of depth of knowledge and life experience.
Mollie, by the way, was the first woman to serve as the Director of
the Fish and Wildlife Service. During the Eisenhower administration, I
served in the Interior Department for almost 5 years, and I know of the
mission of that service and its continuing benefit to the American
public.
Mollie was and is a champion of resource conservation. I do not think
we really had any disagreement as to the end result that we sought, but
perhaps some of the means to get there.
She came to the Fish and Wildlife Service from the Richard A.
Snelling Center for Government in Vermont, where she was the executive
director. Prior to that, she served in several Vermont State land
management agencies. I am happy that the senior Senator from Vermont,
Mr. Leahy, and the junior Senator, Mr. Jeffords, have asked to
cosponsor the bill that I will send to the desk in a few moments.
In her last major speech as Director of the Fish and Wildlife
Service, Mollie recalled releasing Hope, a rehabilitated bald eagle, as
a highlight of her career. Her career has had many high moments. She
has focussed on reconnecting the American people to the wildlife around
them. Those of us who have worked with Mollie really are saddened to
learn about her condition. We send her and her husband, Rick, our
sincerest sentiments and really want him to know that, from a
professional point of view, his wife has enjoyed the greatest of
friendships in the Congress regardless of party.
There being no objection, the bill was ordered to be printed in the
Record, as follows:
S. 1899
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
Sec. 1. Short Title.--This Act may be cited as the ``Mollie
Beattie Alaska Wilderness Area Act.''
Sec. 2. Mollie Beattie Alaska Wilderness Area.--Amend P.L.
96-487 by striking Section 702(3) and inserting in lieu
thereof the following:
``(3) Arctic National Wildlife Refuge Wilderness of
approximately eight million acres as generally depicted on a
map entitled ``Arctic National Wildlife Refuge'' dated August
1980. That portion of the Arctic National Wildlife Refuge
Wilderness located in the Brooks Range on a map to be
prepared by the Secretary of the Interior shall be named and
appropriately identified as the ``Mollie Beattie Alaska
Wilderness Area'';''
Sec. 3. Placement of Monument.--The Secretary of the
Interior shall place a monument in honor of Mollie Beattie's
contributions to fish, wildlife, and waterfowl conservation
and management at the entrance to the Mollie Beattie Alaska
Wilderness Area or another suitable location he designates.
Such sums as may be necessary are authorized for the
placement of such monument.
[[Page S6725]]
Mr. JEFFORDS. Mr. President, today we dedicate a beautiful area of
Alaska as the Mollie Beattie Fish and Wildlife Refuge. More than any
person this century, Mollie has led the fight to protect our Nation's
natural heritage. Her dedication to preserving wildlife and wildlife
habitat and her spirit and enthusiasm in accomplishing this important
goal will be appreciated by generations to come.
Mollie and I share much in common. We both love the wild, appreciate
its complexity and beauty and value that it contributes to our lives.
We also recognize the importance of protecting fragile ecosystems, from
wetlands to forests. Finally, we both love Vermont and have worked
together to preserve its distinctive character.
I have followed Mollie's career throughout her time in Vermont and
here in Washington. A resident of Vermont since 1968, Mollie used her
calm and determined manner and her knowledge of animals, plants, and
natural resources to institute policies which today are a model of
environmental protection. As a reporter, a University of Vermont
professor and the developer of an experimental game bird habitat,
Mollie strove to integrate her values into each position and left
behind a legacy of success.
As Commissioner of the Vermont Department of Forests, Parks, and
Recreation in the late 1980's, Mollie oversaw all of Vermont's public
lands, including wildlife habitat areas and 48 State parks. In 1989,
she became Deputy Secretary for Vermont's Agency of Natural Resources,
caring for forests, public lands, water quality, air quality, and
wildlife. After a stop over as Executive Director of the Richard A.
Snelling Center for Government in Burlington, Mollie was nominated by
President Clinton to serve as Director of the U.S. Fish and Wildlife
Service. I have never known, in my 22 years representing Vermont, a
person with greater dedication to preserving our Nation's wildlife.
I remember soon after her appointment, Mollie came to visit me here
in the Senate. We spent time discussing the future of the refuge system
and prospects for Endangered Species Act reform. We also reviewed our
Nation's ability to curb the unnecessary slaughter of tigers, rhinos,
elephants, and species rapidly disappearing from other countries. Her
commitment to ending the rapid loss of species was remarkable. Since
her arrival here in Washington, she recognized the importance of our
Nation's wildlife refuge system and has been successful in protecting
these vital resources. She did so effectively and I assure you that our
children and their children will forever cherish this determined
woman's work.
During her tenure at the Fish and Wildlife Service, Mollie visited
Alaska several times and shared with me some of her special memories of
the State. These visits made a remarkable impression on Mollie,
especially her trip to the Arctic Refuge two summers ago. I can think
of no better tribute than to name the 8 million acres of wilderness in
the Arctic Refuge after Mollie. This area captures the ideals and
beauty that Mollie strove to protect while at the Fish and Wildlife
Service.
Mr. President, I want to thank Mollie Beattie on behalf of all my
colleagues in the U.S. Senate and all Americans for all that she has
done to make America a more beautiful Nation.
______
By Mr. DORGAN (for himself, Mr. Grassley, Mr. Harkin, and Mr.
Rockefeller):
S. 1900. A bill to amend title XVIII and XIX of the Social Security
Act to permit a waiver of the prohibition of offering nurse aide
training and competency evaluation programs in certain nursing
facilities; to the Committee on Finance.
______
By Mr. DORGAN (for himself and Mr. Grassley):
S. 1901. A bill to amend title XIX of the Social Security Act to
repeal the requirement for annual resident review for nursing
facilities under the Medicaid program and to require resident reviews
for mentally ill or mentally retarded residents when there is a
significant change in physical or mental condition; to the Committee on
Finance.
long-term-care legislation
Mr. DORGAN. Mr. President, today I am introducing legislation that
will relieve nursing homes of unnecessary regulation without
jeopardizing the high quality of care nursing home residents receive.
These two bills, which enjoy bipartisan support, will improve long-term
care in this country by giving nursing homes the flexibility they need
to focus scarce resources on providing quality care.
I have long believed that the Federal Government has an important
role to play in ensuring against the kinds of abuses that occurred in
some areas of the country prior to enactment of Federal nursing home
standards. I do not believe that those abuses were the norm in nursing
homes. In fact, nursing homes in my State of North Dakota have a strong
record of providing quality care, and I believe that this was the case
in most nursing homes.
But it is clear that some nursing homes did not meet that high
standard, and many States were far too slow to respond. To address that
critical problem, I supported and continue to support minimum Federal
quality standards. Our first priority in nursing home legislation must
be the quality of care provided to residents, and we should not pass
any laws that would compromise that goal.
However, I believe that some of our efforts to regulate nursing homes
have not resulted in greater quality of care for residents. In some
cases, by imposing unnecessary burdens and diverting scarce resources
in nursing facilities, these laws and regulations can hinder the
delivery of quality care. The legislation I am offering today will
address two such instances.
nurse-aide training program
The first bill I am introducing has enjoyed broad bipartisan support
during the 104th Congress. I am joined in offering this bill by Senator
Grassley and Senator Harkin. This bill would exempt rural nursing
facilities from the possibility of termination of their nurse-aide
training programs for reasons unrelated to the quality of the training
program
Simply put, this is a commonsense amendment. In rural areas all over
the country, nursing facilities offer people an opportunity to learn
the basic nursing and personal care skills needed to become a certified
nurse aide. In return, those who participate in a nurse-aide training
program help nursing facilities meet their staffing needs and allow the
nursing staff to focus more on administering quality nursing care.
Nurse-aide training programs are especially important in rural areas
like my State of North Dakota, where potential nurse aides might have
to travel hundreds of miles for training if it is not available at the
nursing facility in their community. These nurse-aide training programs
comply with strict guidelines related to the amount of training
necessary and determination of competency for certification.
Despite these safeguards, current law allows programs to be
terminated for up to 2 years if a facility has been cited for a
deficiency or assessed a civil money penalty for reasons completely
unrelated to the quality of the nurse-aide training program. In North
Dakota, this could result in real hardship not just for the nursing
facility and potential nurse aides, but for the nursing home residents
who rely on nurse aides for their day-to-day care.
Under my bill, rural areas would be exempt from termination of nurse-
aide training programs in these specific instances only if: first, no
other program is offered within a reasonable distance of the facility;
second, the State assures that an adequate environment exists for
operating the program; and third, the State provides notice of the
determination and assurances to the State long-term care ombudsman.
Congress included this exception for rural nurse-aide training
programs in the Balanced Budget Act passed last December, and the
President included it in his 1997 budget proposal.
annual resident reviews
The second bill I am introducing today relates to the pre-admission
screening and annual resident review [PASARR] requirements enacted as
part of OBRA '87. Senator Grassley joins me in introducing this bill,
which also has bipartisan support and was included in the President's
balanced budget proposal.
PASARR was enacted to prevent inappropriate placements of residents
with mental health or developmental disabilities. The need for
assessments to determine whether a mental health
[[Page S6726]]
or developmental disability exists is critical, and we still have some
way to go in ensuring that residents with these problems receive
appropriate placement and treatment in all cases.
However, the annual resident review process duplicates other
mandatory assessments and has not resulted in identifying inappropriate
placements or improving the quality of care for nursing home residents.
The current law adds an average of $700,000 to State costs for long-
term care and diverts valuable nursing facility resources. We must
continue to work to ensure that nursing home residents receive the
quality care they need, but we should not do so by placing unnecessary
or ineffective burdens on nursing facilities and their staffs.
My bill would retain the pre-admission screening for each resident,
but would repeal the annual resident review requirement for each
patient. This would go a long way toward streamlining the regulatory
process and allowing nursing homes to focus more time on providing
quality care.
I hope my colleagues will join me in supporting these sound policy
proposals.
____________________