[Congressional Record Volume 142, Number 94 (Monday, June 24, 1996)]
[Senate]
[Pages S6719-S6724]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      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.
                                 ______