[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]



 
 DIRECT-TO-CONSUMER GENETIC TESTING AND THE CONSEQUENCES TO THE PUBLIC 
                                 HEALTH

=======================================================================

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             SECOND SESSION

                               __________

                             JULY 22, 2010

                               __________

                           Serial No. 111-148


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov



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                    COMMITTEE ON ENERGY AND COMMERCE

                 HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan            JOE BARTON, Texas
  Chairman Emeritus                    Ranking Member
EDWARD J. MARKEY, Massachusetts      RALPH M. HALL, Texas
RICK BOUCHER, Virginia               FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey       CLIFF STEARNS, Florida
BART GORDON, Tennessee               NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois              ED WHITFIELD, Kentucky
ANNA G. ESHOO, California            JOHN SHIMKUS, Illinois
BART STUPAK, Michigan                JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York             ROY BLUNT, Missouri
GENE GREEN, Texas                    STEVE BUYER, Indiana
DIANA DeGETTE, Colorado              GEORGE RADANOVICH, California
  Vice Chairman                      JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California               MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania       GREG WALDEN, Oregon
JANE HARMAN, California              LEE TERRY, Nebraska
TOM ALLEN, Maine                     MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois       SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas           JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington               TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin             MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas                  MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York          PHIL GINGREY, Georgia
JIM MATHESON, Utah                   STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin 
    Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
PETER WELCH, Vermont
              Subcommittee on Oversight and Investigations

                    BART STUPAK, Michigan, Chairman
BRUCE L. BRALEY, Iowa                GREG WALDEN, Oregon
  Vice Chairman                        Ranking Member
EDWARD J. MARKEY, Massachusetts      ED WHITFIELD, Kentucky
DIANA DeGETTE, Colorado              MIKE FERGUSON, New Jersey
MIKE DOYLE, Pennsylvania             TIM MURPHY, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois       MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas
DONNA M. CHRISTENSEN, Virgin 
    Islands
PETER WELCH, Vermont
GENE GREEN, Texas
BETTY SUTTON, Ohio
JOHN D. DINGELL, Michigan (ex 
    officio)
  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Bart Stupak, a Representative in Congress from the State of 
  Michigan, opening statement....................................     1
    Prepared statement...........................................     4
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................    10
    Prepared statement...........................................    12
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, opening statement...............................    19
    Prepared statement...........................................    21
Hon. Parker Griffith, a Representative in Congress from the State 
  of Alabama, opening statement..................................    24
Hon. Diana DeGette, a Representative in Congress from the State 
  of Colorado, opening statement.................................    25
Hon. Robert E. Latta, a Representative in Congress from the State 
  of Ohio, opening statement.....................................    26
    Prepared statement...........................................    27
Hon. Donna M. Christensen, a Representative in Congress from the 
  Virgin Islands, opening statement..............................    30
Hon. Phil Gingrey, a Representative in Congress from the State of 
  Georgia, opening statement.....................................    30
Hon. Joe Barton, a Representative in Congress from the State of 
  Texas, prepared statement......................................   180

                               Witnesses

Gregory Kutz, Managing Director, Forensic Audits and Special 
  Investigations, Government Accountability Office...............    32
    Prepared statement...........................................    35
    Answers to submitted questions...............................   183
Jeffrey Shuren, M.D., Director, Center for Devices and 
  Radiological Health, U.S. Food and Drug Administration.........    68
    Prepared statement...........................................    70
James Evans, Editor-in-Chief, Genetics in Medicine, Bryson 
  Professor of Genetics and Medicine, University of North 
  Carolina at Chapel Hill........................................   100
    Prepared statement...........................................   103
    Answers to submitted questions...............................   187
Ashley Gould, General Counsel, 23andMe...........................   107
    Prepared statement...........................................   109
    Answers to submitted questions...............................   191
Vance Vanier, President and CEO, Navigenics, Inc.................   142
    Prepared statement...........................................   144
    Answers to submitted questions...............................   211
David Becker, Chief Scientific Officer, Pathway Genomics 
  Corporation....................................................   150
    Prepared statement...........................................   152
    Answers to submitted questions...............................   217


 DIRECT-TO-CONSUMER GENETIC TESTING AND THE CONSEQUENCES TO THE PUBLIC 
                                 HEALTH

                              ----------                              


                        THURSDAY, JUNE 22, 2010

                  House of Representatives,
      Subcommittee on Oversight and Investigations,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 9:34 a.m., in 
Room 2123, Rayburn House Office Building, Hon. Bart Stupak 
[chairman of the subcommittee] presiding.
    Present: Representatives Stupak, DeGette, Christensen, 
Waxman (ex officio), Burgess, Gingrey, Griffith, and Latta.
    Staff Present: Phil Barnett, Staff Director; Bruce Wolpe, 
Senior Advisor; Stephen Cha, Professional Staff Member; Eric 
Flamm, FDA Detailee; Dave Leviss, Chief Oversight Counsel; 
Meredith Fuchs, Chief Investigative Counsel; Tiffany Benjamin, 
Counsel; Erika Smith, Professional Staff Member; Ali Neubauer, 
Special Assistant; Derrick Franklin, HHS Detailee; Karen 
Lightfoot, Communications Director, Senior Policy Advisor; 
Elizabeth Letter, Special Assistant; Alan Slobodin, Minority 
Counsel; Melissa Bartlet, Minority Counsel; Robert Frisbee, 
Minority Detailee; and Garrett Golding, Minority Legislative 
Analyst.

  OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MICHIGAN

    Mr. Stupak. This meeting will come to order.
    Today we have a hearing entitled, ``Direct-to-Consumer 
Genetic Testing and the Consequences to the Public Health.''
    The chairman, ranking member, and chairman emeritus will be 
recognized for a 5-minute opening statement. Other members of 
the subcommittee will be recognized for a 3-minute opening 
statement. I will begin.
    ``Genetic testing can effect how well some drugs work for 
you or whether they work at all.'' ``Learn if you have a 
propensity for obesity, cancers, diabetes, and more.'' These 
are some of the claims featured on the Web sites of two of the 
direct-to-consumer genetic testing companies we are examining 
in today's hearing. These companies and their competitors make 
enticing claims about what this promising new field of research 
can offer the American consumer.
    I am sure that many people would want to know if they have 
a higher risk of being diagnosed with colon cancer or if your 
body is likely to react poorly to a drug that treats heart 
disease. With the decoding of the human genome, medical science 
opened up the possibility of detecting people's predisposition 
to disease, establishing a better understanding of family 
ancestry, and the developing drugs that are designed to treat 
genetic conditions.
    Some companies are now marketing personalized genetic 
tests, claiming they have the ability to provide extensive 
information about their health with the simple swab of their 
cheek. These companies tell consumers that greater genetic 
testing can predict whether they are more likely to develop 
diseases such as breast cancer, diabetes, cystic fibrosis, 
celiac disease, and heart disease. The companies state that 
genetic tests also inform consumers of how they are likely to 
react to prescription drugs taken to treat HIV or high blood 
pressure.
    But how accurate are these companies' analysis of direct-
to-consumer genetic tests? Sending the consumer the results of 
genetic tests without counseling or medical advice may cause 
more harm than good for some consumers. How accurate is the 
health information? How do companies explain differences in 
their analyses? Is there sufficient government oversight of the 
practices of direct-to-consumer genetic testing manufacturers? 
Today we will seek answers to these questions as we examine 
direct-to-consumer genetic testing kits and their potential 
implications for public health.
    A 2008 article in the Journal of the American Medical 
Association entitled, ``Risks and Benefits of Direct-to-
Consumer Genetic Testing Remain Unclear,'' claims that, and I 
quote, ``Companies cannot demonstrate causation, and many of 
the markers being used by the testing companies have not been 
validated by other groups or by studies that the molecular 
mechanism by which these genes might lead to disease,'' end of 
quote.
    Yet, this subcommittee has learned that some direct-to-
consumer genetic testing companies are advising their customers 
that, based on genetic data, their body is likely to react 
favorably or unfavorably to certain medications.
    For example, we discovered internal company documents 
demonstrating that one company informed consumers based on 
their genetic markers that they are likely to have a low risk 
of side effects should they use a certain cancer drug, 
irinotecan, a drug commonly used to treat colorectal and other 
cancers. The document goes on to say that, because of the low 
risk of a bad drug reaction to the drug, if a person is treated 
for cancer, the medical team may want to prescribe this cancer-
fighting drug.
    Today's hearing continues previous inquiries within the 
Subcommittee on Oversight and Investigation of genetic testing 
issues. In March 2009, Chairman Waxman and I joined Ranking 
Member Barton and subcommittee Ranking Member Walden in a 
request to the Government Accountability Office to investigate 
concerns that the genetic testing market appears to have 
expanded rapidly and consumer fraud in this area is on the 
rise. Our letter requested the GAO direct its Forensic Audit 
and Special Investigations Unit to perform proactive testing of 
the actual products currently marketed by several companies and 
of the advertising methods used to sell these products to 
consumers. I thank the chairman and my colleagues for working 
together on this important bipartisan inquiry.
    During the course of our investigation, GAO found that some 
direct-to-consumer genetic testing companies provide misleading 
results from genetic testing kits. GAO concluded that risk 
predictions often conflicted with the donors' factual illnesses 
and family medical histories. For example, one of the donors in 
the GAO investigation had a pacemaker implanted 14 years ago to 
treat an irregular heartbeat, but his genetic test came back 
stating that he was at decreased risk for developing a heart 
condition.
    When GAO consulted with medical and genetic experts, they 
were told that the direct-to-consumer tests are not diagnostic. 
As a result, the medical predictions based on genetic test 
results defy actual medical histories. What is less clear is 
whether the companies are accurate in describing test results 
to their customers.
    Today, Mr. Gregory Kutz, managing director, Forensic Audits 
and Special Investigation, with the Government Accountability 
Office, will be informing the subcommittee of their findings. 
Mr. Kutz's team conducted the investigation into five direct-
to-consumer genetic testing companies.
    Joining Mr. Kutz is Dr. Jeff Shuren, director of the Center 
for Device and Radiological Health with the Food and Drug 
Administration. FDA represents the Federal agency responsible 
for the regulation of these direct-to-consumer genetic tests.
    We will also be hearing from direct-to-consumer genetic 
testing companies. I look forward to hearing from these 
companies about the quality of the products and services they 
offer and the steps they take to protect the American consumer.
    Joining the manufacturers is Dr. James T. Evans, a 
professor and director of genetics and medicine at the 
University of North Carolina at Chapel Hill. Dr. Evans is an 
advisor to the U.S. Secretary of Health and Human Services on 
the subject of genetics, health, and society. Dr. Evans 
currently serves as the editor-in-chief of Genetics in 
Medicine, the official journal of the American College of 
Medical Genetics.
    I want to thank our witnesses for their cooperation in 
appearing before us today. I look forward to their testimony 
and to learning more about the promises and risks in this 
exciting new field.
    [The prepared statement of Mr. Stupak follows:] 

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    Mr. Stupak. I would also ask unanimous consent that 
Congresswoman Louise Slaughter's statement be made part of my 
opening statement, without objection.
    [The information was unavailable at the time of printing.]
    Mr. Stupak. I would next turn to Mr. Burgess for an opening 
statement.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE 
              IN CONGRESS FROM THE STATE OF TEXAS

    Mr. Burgess. I thank the chairman and I thank Chairman 
Waxman for convening this hearing. It is an important topic.
    The advancements in genomics, as we have heard in other 
subcommittees in the Committee on Energy and Commerce, have 
been startling. The Human Genome Project was certainly a long 
time in coming but worth the wait, and the excitement it has 
provided has proved that point. The discovery of over 1,800 
genes linked to disease is nothing short of remarkable. The 
promise this research holds to help those suffering or likely 
to suffer from diseases and medical conditions is very real. We 
cannot overstate the significance of these advances, and I have 
no doubt that genomics will revolutionize the daily practice of 
medicine.
    However, we also have to be concerned about a rush to 
commercialization. It is imperative that the information 
consumers receive is reliable and accurate. As an obstetrician/
gynecologist, I'm disturbed by a recent Washington Post article 
where the Food and Drug Administration asserts that patients 
may have had surgery, irreversible surgery, based on 
questionable results of genetic tests for a certain type of 
cancer. Consumers should have access to information, but it 
must be reliable and accurate. No one should be required to 
make an irreversible health decision, such as a surgical 
procedure, based on unsettled or evolving science.
    Findings from the Government Accountability Office's 
undercover work with genetic testing companies raises these 
very concerns. The GAO's secret shoppers or fictitious 
consumers received disease risk predictions that varied greatly 
across the different companies. One person was deemed at below-
average, average, and above-average risk for prostate cancer 
and hypertension from four different companies. And in this 
sort of testing, you don't get to pick the best two out of 
three.
    Overall, the GAO found 68 percent of the time the donor DNA 
samples resulted in different risk predictions for the same 
disease. This lack of consistency may indicate the state of the 
science, but it also begs the question: How can consumers know 
their true risk?
    Furthermore, it is very difficult that companies promise 
impossible results, tell consumers that they will definitely 
get cancer, or inappropriately claim celebrity endorsement. One 
company counseled a patient that the above-average risk 
prediction for breast cancer meant that she was, quote, ``in 
the high risk of pretty much getting,'' closed quote, the 
disease.
    The examples by the Food and Drug Administration and the 
Government Accountability Office show that there is cause for 
concern about these tests. I'm a proponent of personalized 
medicine, but I fear that these practices might confuse the 
potential for these tests to be of benefit in the future. 
Genetic testing will not realize its potential if the 
components are unreliable or, worse, if fraudulent information 
is pushed.
    Apparently, a director of research and development at 
Pathway Genomics agrees. In a March 17, 2010, e-mail to her 
colleague regarding weight management genetic testing for 
contestants of the popular television show ``The Biggest 
Loser,'' she raises concerns about the ability to distinguish 
the real science from the hot topics that are generally not 
validated science or to meet any criteria for strength of 
genetic association.
    On March 18, her colleague responds that she, too, has on 
many occasions tried to raise the scientific red flag in 
meetings. If the people doing the research at these companies 
question the tests' reliability, then there are certainly going 
to be issues for the consumer.
    One might argue that greater Food and Drug Administration 
regulation of the results is needed, and I believe we must ask, 
are the kits themselves properly regulated? The Food and Drug 
Administration recently sent letters to commercial genetic 
testing companies asserting regulatory authority over their 
products. Also, the FDA convened a public meeting to look at 
the broader issues of regulating the developed tests. I do want 
to hear from the Food and Drug Administration about their 
plans.
    But a more basic question for the FDA is, is the science 
sound enough to support this market? Can the Food and Drug 
Administration police genetic tests with a science that is so 
new and so rapidly changing? If people become uncertain as to 
the reliability of the results of genetic testing because that 
reflects the infancy of the science, then medicine may never 
reap the benefits that this science holds.
    Finally, and to the Food and Drug Administration, the 
science may not be there yet--and I would stress the ``yet''--
but it will be, so you must be ready. Needed tests and cures 
should not be denied down the road because our Federal agency, 
the Food and Drug Administration, has not yet figured out how 
to adapt to the science.
    Ponder this: How will the FDA regulate personalized 
pharmaceutical and biologic products? How do you do randomized 
clinical trials on personalized therapies, on therapies that 
are developed for a single patient? The future may not be here 
yet, but it is right over the horizon.
    Thank you, Mr. Chairman, for holding this hearing. And I 
will yield back the balance of my time.
    [The prepared statement of Mr. Burgess follows:]

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    Mr. Stupak. Thank you, Mr. Burgess.
    Mr. Waxman, Chairman Waxman, for an opening statement, 
please.

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Mr. Waxman. Thank you very much, Chairman Stupak, for 
holding this oversight hearing.
    This is an important issue for us to examine, the direct-
to-consumer genetic testing. The companies that are offering to 
do this recognize there is a heightened interest in the whole 
idea of unravelling the mysteries contained in people's own 
genome and how it might apply to their personal health. And 
there has been rapid progress in the scientific research on 
human genetics, which makes all of us very excited.
    But we need to look at some of the statements and claims 
that are being made to the average consumer when they look at 
the Web site of some of the leading direct-to-consumer genetic 
testing companies.
    Navigenics, one of the companies that we will hear from 
today, promises on its Web site that its product offers, quote, 
``a new look at a healthier future.'' And you can see on the 
screen their claims.
    23andMe, another company testifying today, offers these 
enticements to the potential consumer of its genetic testing 
kits: Quote, ``Take charge of your health. Live well at any 
age,'' end quote. ``Let your DNA help you plan for the 
important things in life.''
    Pathway Genomics, the third company testifying today, 
advises on its Web site that, quote, ``Knowing how your genes 
may affect your response to certain drugs may improve the 
quality of your life,'' end quote.
    And deCODEme, a fourth company whose genetic testing kit 
GAO reviewed, states on its Web site that, quote, ``Your genes 
are a roadmap to better health,'' end quote.
    The problem with these marketing practices is that it is 
not clear today whether the exciting scientific developments in 
human genetics research actually transfer into ways to improve 
and individualize medical care. The science informs us that 
there is no widespread accepted consensus linking genetic 
markers to many specific illnesses. While understanding human 
DNA may someday help us cure hundreds of serious illnesses, 
companies need to be careful that they are not overstating what 
they have to offer the public. And if a company is making a 
claim regarding the consumer's use of its products and that 
person's health, then the company should be subject to 
compliance with all applicable public health laws and 
regulations.
    Two agencies of the government share jurisdiction over 
direct-to-consumer genetic tests. Under the Clinical Laboratory 
Improvement Act, CLIA, the Centers for Medicare and Medicaid 
Services, CMS, regulates the laboratories that conduct the 
testing but not the health claims made by genetic testing 
manufacturers.
    The U.S. Food and Drug Administration, FDA, has 
jurisdiction over diagnostic tests, which are intended for use 
in the collection, preparation, and examination of specimens 
taken from the human body and are considered medical devices. 
The three companies testifying today have previously claimed 
that their products are not medical devices and, thus, do not 
require approval from FDA before they can be sold to consumers.
    In May of this year, Walgreens and Pathway Genomics 
announced a partnership to sell direct-to-consumer genetic 
testing kits to consumers over the counter. In response to this 
announcement, the FDA sent a letter to Pathway Genomics stating 
that these products fell under the oversight of FDA and that 
the genetic testing kits had not been approved by the FDA.
    Shortly thereafter, FDA sent letters to 23andMe, Navigenics 
Health Compass, and deCODE Genetics, stating their products 
were medical devices but had not been submitted for premarket 
review. This week, FDA approached 14 other companies on these 
issues.
    And FDA is here today to discuss their actions. I applaud 
FDA's efforts to protect the American consumer. I hope we will 
hear from the genetic testing companies today that they will 
cooperate with FDA's enforcement efforts.
    Our committee has also conducted its own investigation, 
reviewing over 450,000 documents. We have uncovered 
questionable marketing claims, serious quality control and 
privacy concerns, and questions about the accuracy of 
information provided to consumers.
    Last year, members of our committee asked the GAO to 
evaluate these issues, and GAO is going to report to us today. 
Three of the companies the GAO tested have come here to discuss 
their work, provide their insights into what the committee and 
GAO found. I thank them for their cooperation.
    In addition, Dr. James Evans, a practicing physician and 
expert in medical genetics, will give us the clinician's 
perspective on the value of the companies' analysis and the 
questions they raise.
    Thank you, Mr. Chairman. We need to ensure the public is 
protected against exaggerated claims, abusive marketing, and 
practices that threaten individual health and safety.
    [The prepared statement of Mr. Waxman follows:]

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    Mr. Stupak. Thank you, Chairman Waxman.
    I had asked before Mr. Burgess's opening statement that 
Congresswoman Slaughter from the 28th district of New York, 
that her statement be made part of my opening statement. 
Without objection, that will be the case.
    Next we will go to Mr. Griffith for an opening statement, 
please, 3 minutes.

OPENING STATEMENT OF HON. PARKER GRIFFITH, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF ALABAMA

    Mr. Griffith. Thank you, Mr. Chairman and Ranking Member, 
for this opportunity, this hearing investigating direct-to-
consumer genetic testing.
    I would also like to thank those witnesses that are here to 
help us with this investigation.
    Today we will closely examine genetic testing and how 
effective the results have been for consumers. It is evident 
that, as young as this industry is, there are many things that 
need to be investigated. Providing a safe, effective product 
for the public is, of course, the main concern that we will 
look at today. I'm hoping this discussion today will bring 
valuable insight into the scientific and ethical issues 
surrounding the personal genomics industry.
    These tests can provide consumers with the information to 
motivate them to live healthier lives. The development of the 
tests can help individuals identify if they are at risk for 
particular medical conditions and seek out specific medical 
treatments. On the other hand, if the tests are inaccurate, it 
can lead to confusion, fear, or misdiagnosis, and even 
unnecessary testing and death.
    In addition, for the average consumer, the results of these 
tests can be too confusing and too complicated for individuals 
and their families to deal with. It is vital we prepare 
consumers with the background knowledge and tools they need to 
interpret their own genetic data in a safe and informed manner.
    There have already been evidences of consumer fraud, and we 
must make sure that this does not continue.
    As a physician for 40 years, I understand how important it 
is to provide accurate health care information to individuals 
so they can make important medical decisions. We need to ensure 
that, moving forward from today, that these companies have this 
same goal. The answer may not be to take these tests away from 
the public use, as they could be helpful in prevention of 
disease, but we do need to drive a discussion today on how to 
better protect the public.
    I might say that the diseases that draw the most attention 
are cancer, Alzheimer's--those we fear the most. If I were to 
stand up and pull a snake out of my pocket right now and throw 
it into this audience, very few of you would decide whether it 
was poisonous or not; everybody would be headed for the door.
    No one is more vulnerable to medical fraud than the 
concerned individual about a family history or a disease. No 
one is more sensitive to the mysteries of their bodies and 
genetic testing. And so the marketing of this particular aspect 
of medicine is fraught--fraught--a minefield of fraud and 
abuse, pushed by the profit motive, which we admire, but we do 
know in medicine it can be a problem.
    So, with that, I appreciate it very much, Mr. Chairman. 
Thank you.
    Mr. Stupak. Thank you, Mr. Griffith.
    Ms. DeGette for an opening statement, please.

 OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF COLORADO

    Ms. DeGette. Thank you very much, Mr. Chairman. I want to 
thank you for holding this hearing on a very important and 
cutting-edge issue.
    Ever since the Human Genome Project was completed in 2003, 
invigorated scientific interest in genetic analysis and testing 
has led to complex breakthroughs and now to a process so 
streamlined it can be marketed directly to the individual 
consumer. So, today, because of this, we stand at a moral, 
ethical, and health crossroads, where a significant examination 
from regulatory agencies is absolutely critical.
    Without a doubt, advances in the field have created 
opportunities for consumers to improve their health through the 
early detection of certain genetic predispositions. For 
example, when the technology warns somebody that they are at 
risk for diabetes in enough time to make significant lifestyle 
changes in the form of diet and exercise, this helps stave off 
the onset of the disease. And, in addition, knowledge of an 
individual's unique genetic composition will allow doctors to 
give medicine for treatment that they know the bodies of the 
patients will not reject.
    But as we move forward, we have to do so cautiously. 
Intertwined with the promise of direct-to-consumer genetic 
testing are the perils of what can happen when this information 
is used inappropriately.
    As a threshold matter, the information provided through 
direct-to-consumer genetic testing must remain private. When 
President Bush signed GINA, the Genetic Information 
Nondiscrimination Act, in 2008--and this committee worked for 
many years on that legislation--it was an important step 
towards ensuring a person's genetic composition would not 
subject them to maltreatment at the hands of insurance agencies 
and employers. So, today, faced with the reality of genetic 
testing becoming infinitely more available and more prevalent, 
it is even more imperative that we make sure that each and 
every individual's privacy is ensured.
    Of equal importance to this is that easily identifiable 
scientific standards are adopted across the board. Before 
becoming the director of the NIH, Dr. Francis Collins, in 
researching his book, ``The Language of Life: DNA and the 
Revolution of Personalized Medicine,'' was shocked to find 
out--and some of you here know this. When he sent his own 
genetic sample to the three leading companies, the results he 
received in return differed. With the potential volatility of 
this information, such inconsistencies are impermissible. So we 
have to have a recognizable set of standards.
    You know, Dr. Collins, what he did when he got these three 
results that differed so much, he just went back in and just 
tested his own genome because he can do that. The average 
consumer cannot conduct independent verification tests.
    And, in addition, they need some help from their doctors to 
figure out exactly what these test results mean, what the 
emotional and physical burden will be. All of these things are 
important.
    I'm excited about the potential for genetic testing, Mr. 
Chairman, but I also think we need to make sure that we have 
all the protections available.
    Mr. Stupak. Thanks, Ms. DeGette.
    Mr. Latta, opening statement, 3 minutes.

OPENING STATEMENT OF HON. ROBERT E. LATTA, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF OHIO

    Mr. Latta. Thank you, Mr. Chairman, Ranking Member Burgess. 
Thank you very much for holding this subcommittee hearing on 
direct-to-consumer genetic testing and the consequences to the 
public health.
    Advances in technology led to incredible discoveries in the 
field of genetics and that an individual can take a simple test 
in order to find out if he or she is predisposed to certain 
diseases. Such developments have many potential applications to 
consumers, and I believe that this is an area that is an 
important step in the direction of giving individuals more 
power over their own personal health decisions.
    The rapidly growing field of genetic testing symbolizes the 
entrepreneurial spirit and innovation that makes America great. 
The possibility of excessive government regulations, which 
would and could effectively put an end to an increasing 
technology, should not be our goal. Rather, since the field of 
genetic testing is still developing, it is important to bring 
together all the stakeholders to discuss the ethical and health 
implications and spur the industry to address these concerns.
    Furthermore, we must examine the privacy implications for 
individuals having access to report on their own personal DNA. 
The potential for fraud and disclosure of personal information 
necessitates a close examination of the industry.
    Mr. Chairman, again, thank you very much for holding this 
hearing on direct-to-consumer genetic testing. I look forward 
to hearing the testimony today from our witnesses. And I yield 
back. Thank you very much.
    [The prepared statement of Mr. Latta follows:]

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    Mr. Stupak. Thank you, Mr. Latta.
    Ms. Christensen for an opening statement, please.

       OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A 
       REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS

    Ms. Christensen. Thank you, Mr. Chairman.
    I will admit a bias. As a physician, I was never a fan of 
direct-to-consumer advertising. And the direct-to-consumer 
genetic testing raises even greater concern and poses even more 
serious consequences.
    Having information regarding one's health is important. The 
more, the better. But having the kind of information genetic 
testing could provide without the guidance, the analysis, and 
the interpretation of a health professional can and apparently 
has already led to wrong assumptions and wrong decisions.
    So even before seeing the results of the GAO study, I had 
serious doubts--doubts about the claims of the testing, about 
the cost, and about the diversity of the genetic pool. Clients 
may be duped into thinking they could get the genetic analysis 
by paying the costs of the tests when, in some cases, that is 
an additional cost, a higher cost, that some can't afford.
    The gross underrepresentation of African Americans and 
other minorities in clinical trials has impacted the kind of 
information we could receive from the kind of genetic testing 
generally offered. It is my understanding that, because of 
this, results may come back with no information on some of the 
diseases that cause some of the major health disparities. And 
this is after the client has paid for the information that they 
don't get.
    I had to be, and I'm sure my colleagues had to be, clear 
certified to do simple tests in our office, where I could sit 
and counsel the patients myself. Although GAO showed that the 
information they receive is generally meaningless, to think 
that such testing could be done and reported in such an 
unregulated manner is appalling.
    I commend the FDA for taking this issue on and the 
subcommittee for asking for the investigation. And I thank you, 
Chairman Stupak and Ranking Member Burgess, for holding this 
hearing.
    I yield back my time.
    Mr. Stupak. Thank you, Ms. Christensen.
    Mr. Gingrey, opening statement, please.

  OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF GEORGIA

    Mr. Gingrey. Mr. Chairman, thank you.
    I came in just in time to hear three of my colleagues give 
their opening statements, and they essentially have given two-
thirds of my opening statement. I'm not a bit surprised that I 
would be in agreement with Dr. Christensen in regard to this. I 
mean, obviously, we all have some real serious concerns about 
how this information is used and what the patient's 
understanding of it is.
    Genetic tests, indeed, hold great promise for our health 
care system, but the problem with these tests rests squarely on 
patients having the necessary information available to use the 
results effectively. According to the National Cancer 
Institute's Web site, patients--this is a quote from their Web 
site--``should be informed, both verbally and in writing, about 
the risk of getting tested, as well as what the tests can and 
cannot tell you.'' That is a quote. I cannot agree more with 
these sentiments, as I said, expressed by my colleagues.
    Personal genetic testing kits, on the other hand, are 
generally sold to patients through the Internet, as I 
understand it. These tests can require that patients send their 
DNA sample through the mail and check the results of their test 
online, hopefully in a secure manner.
    As a provider myself of 31 years, I am very concerned with 
the process I just described. I don't see much opportunity to 
educate patients about the strengths and weaknesses of these 
tests, what test results can and cannot teach patients, and how 
these results, most importantly, should be interpreted. You 
have a lot of hypochondriacs out there in this country, and we 
are going to make maniacs out of them, I fear.
    Tests such as these, they may offer great insights into our 
health status, but the process by which these tests are 
conducted and analyzed should include the sound advice of a 
qualified medical provider, like Dr. Christensen. Without the 
benefit of such medical insight, I fear patients may jump to 
wrong conclusions--indeed, they may even jump off a building--
and create snap medical decisions simply out of fear or 
ignorance. Therefore, I believe that patients should have the 
benefit of medical advice when considering such test results.
    With that thought in mind, I look forward to the testimony 
of all of our witnesses, both panels, in exploring this issue 
in greater detail.
    I've got a few more seconds left. And so quickly--Mr. 
Chairman, this might not surprise you--before I yield back, I 
would be remiss if I didn't once more use my opening statement 
to ask for a congressional hearing on our new CMS 
administrator, Dr. Berwick.
    This committee, Energy and Commerce, Oversight and 
Investigation, this subcommittee seems like an appropriate 
place to ask Dr. Berwick about his thoughts on health care 
rationing and whether it is now the philosophy of our Medicare 
program, or whether Dr. Berwick still believes that a humane 
health care system should transfer the wealth and resources 
from the rich to the poor.
    These are valid questions, questions for which I want 
answers, questions for which my constituents want answers. And 
I would like to believe that finding these answers is not a 
partisan endeavor, but one we can accomplish together. It is 
true that I may not agree with some of my colleagues on what 
the substance of those answers should be, but I think we should 
all be able to agree that getting answers to these questions is 
of utmost importance.
    And, Mr. Chairman, with that, I yield back, having used 23 
extra seconds. And I appreciate your indulgence.
    Mr. Stupak. That concludes the opening statements by 
members of the subcommittee who are present. So we have our 
first panel of witnesses at the table before us.
    On our first panel, we have Dr. Jeff Shuren, director of 
the Center for Devices and Radiological Health at the Food and 
Drug Administration; and Mr. Gregory Kutz, managing director of 
forensic audits and special investigations at the Government 
Accountability Office.
    It is the policy of this subcommittee to take all testimony 
under oath. Please be advised that you have the right, under 
the rules of the House, to be advised by counsel during your 
testimony. Do either of you wish to be represented by counsel?
    Both indicated that you do not. Therefore, I'm going to ask 
you to please rise, raise your right hand, and take the oath.
    [Witnesses sworn.]
    Mr. Stupak. Let the record reflect that the witnesses 
replied in the affirmative. They are now under oath.
    We will begin with opening statements by our witnesses.
    And, Dr. Shuren, we will start with you, please, sir.
    Doctor, I'm sorry. I guess they want Mr. Kutz to go first.
    Greg, do you want to go first then?
    Mr. Kutz. Sure.
    Mr. Stupak. Sorry about that, Doctor.
    Dr. Shuren. Mr. Chairman, I am not going anywhere.
    Mr. Stupak. Go ahead.

 TESTIMONY OF GREGORY KUTZ, MANAGING DIRECTOR, FORENSIC AUDITS 
 AND SPECIAL INVESTIGATIONS, GOVERNMENT ACCOUNTABILITY OFFICE; 
    JEFFREY SHUREN, M.D., DIRECTOR, CENTER FOR DEVICES AND 
     RADIOLOGICAL HEALTH, U.S. FOOD AND DRUG ADMINISTRATION

                   TESTIMONY OF GREGORY KUTZ

    Mr. Kutz. Mr. Chairman and members of the subcommittee, 
thank you for the opportunity to discuss genetic testing. 
Today's testimony highlights the results of our investigation 
into genetic testing products sold directly to consumers.
    My testimony has two parts. First, I will discuss what we 
did, and, second, I will discuss what we found. Also, at the 
end of my presentation, I will play audio excerpts from several 
of our undercover calls of genetic testing companies.
    First, we investigated four companies that have been touted 
as some of the most reputable in the industry. These companies 
claim that their tests will analyze DNA and provide genetic 
risk predictions for conditions such as cancer and Alzheimer's 
disease. They claim that the results of these tests can be used 
by consumers to help prevent them from getting these diseases.
    To test the legitimacy of these claims, we purchased 10 
tests from each of these four companies. The cost of these 
tests range from $300 to $1,000 each. For each of our five 
volunteer donors, we sent two DNA samples to each company. One 
of these samples used factual information, while the other used 
fictitious information, about our age and ethnicity. We used 
bogus identities for all five of our donors.
    We compared the risk predictions that we received for each 
donor for 15 diseases and made undercover calls to these 
companies to discuss our results. We consulted with several 
recognized experts in the field of genetics during all phases 
of this investigation.
    We also conducted interviews with each of the four 
companies. Separate from these 40 tests, we made undercover 
calls to 15 companies, including these four, and asked them 
about their test reliability, privacy policies, and their sales 
of nutritional supplements.
    Now that I have set up what we did, let me go to our second 
point, our key findings.
    First, all five donors received conflicting results. 
Assuming these tests are credible, one would expect that the 
same DNA would receive the same predictions. Not so: 68 percent 
of the time, our donors received different predictions for the 
same disease.
    For example, as shown on the monitor, Donor No. 3 was at 
the same time at below-average, average, and above-average risk 
for prostate cancer, high blood pressure, and Type 1 diabetes. 
By the way, Donor No. 3 is me. So, Mr. Chairman, as a consumer, 
which of these predictions should I believe? Dr. Burgess 
advised me to be optimistic and to believe Company No. 2. 
However, what I really believe, as do our experts, is that 
these results show that these tests are not ready for prime 
time.
    We also received disease predictions that conflicted with 
our donors' actual medical history. For example, as mentioned, 
I have in my hand--and for those who can't see, the monitor 
shows--the actual pacemaker one of our donors recently had 
replaced. This pacemaker controlled this donor's atrial 
fibrillation, or irregular heartbeat, for the last 13 years. 
However, according to two of these four companies, this donor 
is at below-average risk for developing atrial fibrillation. 
So, as we've talked here, is this science or is this art?
    We also identified, as mentioned, deceptive and fraudulent 
marketing practices related to genetic testing. For example, I 
have in my hand a bag of nutritional supplements that are 
supposedly customized to my specific DNA. According to the 
sales representative, these supplements can treat or prevent 
arthritis. They can also replace prescription medications for 
high blood pressure and high cholesterol. Sounds great. The 
problem is that these supplements are illegally being marketed 
as a drug without the required FDA approval.
    One company claimed, as mentioned, that Lance Armstrong and 
Michael Phelps used or endorsed their supplements. According to 
representatives for Mr. Phelps and Mr. Armstrong, they have 
nothing to do with these supplements.
    Two companies claim to have a DNA test that will predict 
which sports children will excel at. And, finally, two 
companies told our fictitious consumer that she could secretly 
test her fiance's DNA and surprise him with the results. This 
secret testing is illegal in 33 States.
    In conclusion, our investigation shows that the test 
results that we received, as all of you have mentioned, are 
misleading and, in many cases, not of much value to consumers. 
This is particularly relevant today, as companies are 
attempting to market these tests in retail stores across the 
country.
    These results should not detract from the great promise of 
genetic testing and the progress made. However, consumers need 
to know that, today, genetic testing for certain diseases 
appears to be more of an art than a science.
    As I mentioned, we will now play audio excerpts from some 
of our undercover calls to genetic testing companies, and you 
will see the transcription of the conversations on the monitors 
as you listen.
    [Audio clips played.]
    Mr. Kutz. Mr. Chairman, that ends my statement. I look 
forward to your questions.
    [The prepared statement of Mr. Kutz follows:]

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    Mr. Stupak. Thanks, Mr. Kutz.
    Dr. Shuren, your testimony, please.

               TESTIMONY OF JEFFREY SHUREN, M.D.

    Dr. Shuren. Good morning. And I'm pleased to explain FDA's 
recent activities related to direct-to-consumer genetic tests, 
also called DTC or direct access genetic tests.
    Scientific advances resulting from the Human Genome Project 
have created opportunities to better identify people at risk 
for particular medical conditions and to target medical 
treatments based on the chances that the patient will respond 
to a treatment or experience an adverse event based on their 
genetic profile. FDA supports the promise and development of 
innovative genetic tests.
    However, the field of personalized medicine will not make 
good on that promise if the in-vitro diagnostic tests doctors 
and patients rely on are inaccurate, with only a tenuous link 
between what the test measures and its clinical significance. 
Failure to validate the accuracy, reliability, and clinical 
implications of the test can result in patient harm from 
misdiagnosis, failure to treat, delay or inappropriate 
treatment, or avoidable adverse events. Those risks can be 
increased when the test is marketed directly to consumers 
without medical advice or genetic counseling.
    A genetic test is subject to FDA oversight only if it is a 
medical device--that is, if it is intended in the use of 
diagnosis, cure, treatment, mitigation, or prevention of 
disease. A test to determine a person's risk of developing 
heart disease is a device, but a test to determine ancestry or 
curly hair is not a device.
    At the time of the 2006 GAO investigation, most of these 
diagnostics were nutritional genetic tests that assess what 
kinds of foods consumers should eat and dietary supplements 
they should take. FDA followed up with those companies, and 
FDA, CDC, and FTC published a cautionary statement on DTC 
genetic tests.
    In 2007, FDA began meeting with some of the companies that 
are the subject of the GAO's new investigation. FDA's Center 
for Devices did not inform these companies that they could 
lawfully market their tests without FDA oversight. Instead, the 
Center met with them to gain a better understanding of what 
they were doing or planning to do. At that time, these tests 
were being marketed for such purposes as antiquity 
determinations.
    Since then, though, we have seen changes in the number and 
types of claims being made. One company provided test reports 
for 17 conditions in 2008 but provides over 100 types of 
results now. Some companies now are making claims about high-
risk medical indications like cancer, about the likelihood of 
responding to a specific drug. In many cases, the link between 
the genetic results and the risk of developing a disease or 
drug response has not been well-established. Even the experts 
don't know what the results mean.
    Marketing DTC can increase the risk of the test because a 
patient may make a decision without a medical professional that 
adversely affects their health based on a false result, such as 
stopping or changing the dose of a medication.
    More aggressive DTC marketing efforts became evident 
recently when Pathway Genomics was poised to offer their home-
use saliva-collection kit directly to consumers through more 
than 6,000 Walgreen stores. 23andMe is marketing to consumers 
on Amazon.com.
    The escalation and risk in aggressive marketing caused FDA 
to notify Pathway Genomics on May 10 of this year that their 
offering appeared to meet the definition of a medical device. 
On June 10, FDA sent similar letters to four other diagnostic 
test firms offering their tests directly to consumers. FDA 
considers all of these products to be a medical device on the 
basis of the manufacturers' claims about the test results.
    In addition, a letter was sent to Illumina, Incorporated, 
for supplying an unapproved genetic test to several of these 
DTC companies.
    All six companies have been invited to discuss further the 
regulatory status of their products with FDA. FDA is meeting 
with these companies now and may take additional actions, 
depending on the outcome of those meetings. Earlier this week, 
we sent similar letters to 14 other firms marketing DTC genetic 
tests.
    FDA supports consumers having information about their 
genetic profile. We just believe consumers should have results 
that are accurate, supported by sound science, and 
understandable. We are not being paternalistic; we are being 
patient advocates.
    I commend the subcommittee's efforts to further the 
dialogue about the safety and effectiveness of genetic tests 
being marketed today.
    Mr. Chairman, that concludes my formal remarks.
    [The prepared statement of Dr. Shuren follows:]

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    Mr. Stupak. Thank you, Doctor.
    We will start with questions. I will begin.
    Mr. Kutz, cotton swabs--so how do I go about--if I go 
online, what do I do? Do I have to get a kit? And what does 
that cost me? How do I go about doing it?
    Mr. Kutz. Well, the first step is you need a credit card to 
pay for it.
    Mr. Stupak. OK. Well, that is always number one.
    Mr. Kutz. That is usually the first step. And then when you 
get the actual kit----
    Mr. Stupak. And what does that cost, that actual kit?
    Mr. Kutz. The four we bought were anywhere from about $300 
to a $1,000 each.
    Mr. Stupak. And that was for the kit.
    Mr. Kutz. For the kit. And there were no other products. 
These four companies were not marketing supplements with 
theirs. So that was something very different than what we have 
seen before.
    Mr. Stupak. OK.
    Mr. Kutz. So once you get that, you fill out a certain 
profile information, mostly age and ethnicity. And three of the 
four actually had you spit saliva into a little container and 
then seal that container and put it in the mail. The other one 
used, like, what was a Q-tip to do cheek swabs to get the DNA 
samples, and then you put that into a plastic container and 
send that in.
    Mr. Stupak. OK. And that is costing me anywhere between 
$300 and $1,200 for this test.
    Mr. Kutz. There is others that are more expensive and less 
expensive. There is a lot more on the market. But with these, 
it was $300 to a $1,000.
    Mr. Stupak. OK. What do you estimate Americans spend each 
year on this genetic testing? How large is this industry, would 
you say?
    Mr. Kutz. We don't know. The only source we have seen, I 
think, is the National Academy of Sciences' report. It was 
approaching a billion dollars and growing at 20 or 30 percent a 
year. But I don't think anybody would ever know with the 
Internet being one of the primary ways that this is marketed.
    Mr. Stupak. And so, if it is estimated at a billion dollars 
a year and it is growing at 20 to 30 percent per year--but yet, 
on your reports that you showed, one of the first charts you 
showed, 68 percent of these findings were wrong, correct?
    Mr. Kutz. Well, they differed. For example, you know, when 
I mentioned in my opening statement, for prostate cancer, I had 
different companies tell me I was at below-average, average, 
and above-average risk. So, 68 percent of our 40 tests, we got 
different results for the same disease.
    Mr. Stupak. OK. And how did you get the bag of supplements 
there, that black bag there?
    Mr. Kutz. That was a fifth company we tested. And, 
actually, they were very, very different. They would be more of 
what we would describe as the bottom feeders in this industry, 
the ones who are really more of a consumer scam. They are 
telling you, based on your DNA, that they have customized these 
supplements to me.
    And I've got my fake person's name, and I am not going to 
tell you what it is because we will use it again someday 
probably. But, yes, they are saying if I take these 
supplements, that it is going to reduce the probability I am 
going to get these diseases they say my genetic tests show I'm 
predisposed to have.
    Mr. Stupak. So if it says you are predisposed to high blood 
pressure, they would send you these supplements. And what do 
the supplements cost, that little black bag of supplements?
    Mr. Kutz. $140 a month.
    Mr. Stupak. All right. And how long are you supposed to 
take those supplements, then?
    Mr. Kutz. Forever, I assume. I don't think it said you stop 
at any point. So when you give them your credit card, it is 
$140 a month and they send you a new bag. I think you take 20 
of these a day, is what we were told.
    Mr. Stupak. Do you know what they are, what the pills in 
that bag----
    Mr. Kutz. There's not ingredients. It says it's got a 
number of different plant and herbal and a bunch of things in 
it. But I don't know--I think we've got maybe the detailed 
components. We could provide them for the record, if you're 
interested in that.
    Mr. Stupak. OK. So you really don't know what you are 
taking.
    Mr. Kutz. No, we don't really know what we are taking.
    Mr. Stupak. And it is $140 a month.
    Mr. Kutz. Correct.
    Mr. Stupak. OK.
    Dr. Shuren, in 2009, you testified that the FDA sent 
letters to a variety of companies regarding the direct-to-
consumer genetic testing and medical devices. And then again 
this year, you did the same thing, you sent additional letters 
to companies, informing them they had to go through the medical 
device premarket approval process.
    So the FDA regards these direct-to-consumer genetic tests, 
then, as medical devices?
    Dr. Shuren. Yes, we view these tests by these companies as 
medical devices.
    Mr. Stupak. Would the company then selling me back this 
black bag of supplements every month for $140, would they have 
to get FDA permission to do that?
    Dr. Shuren. If they are making a claim that----
    Mr. Stupak. That it would lower my high blood pressure.
    Dr. Shuren [continuing]. If it is going to lower 
cholesterol, then they are making a drug claim, and the answer 
is, yes, they are selling an unapproved drug.
    Mr. Stupak. So if I do my genetic test and it shows that 
I'm predisposed to high blood pressure, let's say, and I sign 
up for this supplement, bag of supplements, as Mr. Kutz has 
there, then they would have to be registered with the FDA to 
send me that, because they are sending me medication, if you 
will, to lower my blood pressure. Is that correct?
    Dr. Shuren. If they are sending medication to treat high 
blood pressure, they're going to need to get that product 
approved by the FDA.
    Mr. Stupak. OK. So the product has to be approved. They 
would have to have a license, would they not? Would the DEA, 
the Drug Enforcement Administration, yourself, be licensed to 
do this?
    Dr. Shuren. They would have to--if they are now making a 
drug and selling it, then they are going to have to register 
with us. And there is a whole bunch of other requirements. They 
have to meet good manufacturing practices, reporting 
requirements. And it sounds like this company hasn't done any 
of that.
    Mr. Stupak. Mr. Kutz or Dr. Shuren, has any State certified 
these genetic testing kits to be sold in their States? Do you 
need a State certification to sell these?
    Mr. Kutz. I think some States, as we understand it--I don't 
have the details--but do regulate or limit the ability to sell 
these directly to consumers. I don't know which ones, but we 
did see some of that in our research.
    Mr. Stupak. But all you do is go on the Internet, right?
    Mr. Kutz. Yes. And no one is going to know.
    Mr. Stupak. OK.
    Dr. Shuren. And the State of New York, for example, 
prohibits direct-to-consumer marketing. They also, in order to 
use a test on a sample from New York, they will have to approve 
that test before you can use it in that State.
    Mr. Stupak. OK.
    My time has expired. Maybe we will go another round of 
questions. Very interesting. Thank you both.
    Mr. Burgess for questions?
    Mr. Burgess. Thank you, Chairman.
    Dr. Shuren, FDA sent a letter to Pathway Genomics, June 11, 
2009, stating that its health kit, a home DNA test, was a 
device that did not have FDA approval or clearance. And it 
appears that FDA has been corresponding with them for over a 
year. But has any action occurred as a consequence of this?
    Dr. Shuren. No action has occurred until recently, when we 
did send the other letter to say, ``We think it is a device. 
Come in and talk. Otherwise, we are serious about taking 
action.''
    If there is any issue here with the FDA, quite frankly--and 
I will say this--it is, why didn't we act sooner?
    Mr. Burgess. That was going to be my next question.
    Dr. Shuren. And we should have acted sooner.
    Mr. Burgess. So do you have any idea how many of these 
tests have been sold in the year's time, now 13 months' time it 
has taken to get to this point?
    Dr. Shuren. So we should have acted before this time, now. 
And I think the recent actions just, if you will, lit a 
stronger fire under the agency, when we saw Pathway Genomics 
now entering into an agreement with Walgreens to sell their 
collection kit through those pharmacy stores.
    Mr. Burgess. So Walgreens was the catalyst?
    Dr. Shuren. A combination of things. We started to see 
these companies market for higher-risk claims, marketing more 
claims. And we thought, at this point, it is time to take 
action.
    We also were trying to sift through if these companies were 
making tests that might fall under our enforcement discretion 
policy for laboratory-developed tests. And we do not believe 
that these companies are making laboratory-developed tests.
    Mr. Burgess. How many of these companies with whom have you 
been communicating? We have the letters from Pathway. Are all 
the ones on Mr. Kutz's list ones with which you have 
communicated in the past year?
    Dr. Shuren. No. Seven of the companies we have been 
communicating with either in the past year, or just recently we 
sent letters to. Three we have not. We will follow up on the 
information that was given us to GAO. We have also shared this 
information with the Federal Trade Commission as well.
    Mr. Burgess. You know, look over the horizon for just a 
minute. What do you see as the next steps as far as the 
regulatory process? What is going to happen as a consequence of 
the chairman calling this hearing today?
    Dr. Shuren. Sir, what we will be doing with these 
companies, we are giving them an opportunity to come in and 
tell us what is it you want to do? If these companies are going 
to go out and market tests that are not for device claims, they 
are not making medical claims, that is one thing. If they are 
going to go out and make medical claims, then we are going to 
talk about what you need to do in order to sell that test 
lawfully on the market.
    Mr. Burgess. I would just ask the question again: Do you 
have any idea how many of these kits were sold in the year 
between the letter that was sent to Pathway in June of 2009 and 
the present time?
    Dr. Shuren. No, we do not.
    Mr. Burgess. And presumably it is not just Pathway, of 
course; it is the other companies as well. So whatever it is, 
probably you can conservatively multiply it by three or four to 
get to the total number.
    Dr. Shuren. That is correct. I believe 23andMe, and they 
may able to answer this, put some information out they had 
about 50,000 customers for their tests. I believe that is the 
number we heard.
    Mr. Burgess. But that is total. That is not just in the 
last year.
    Dr. Shuren. That is correct.
    Mr. Burgess. Mr. Kutz, do you have any idea over the year 
that we have kind of been aware that there might of sort of be 
a problem here, and now getting really serious about it, do we 
have any idea of how many kits have been sold and how many 
dollars have been spent on this?
    Mr. Kutz. No. This was primarily an undercover 
investigation, so we didn't do a lot of market research, and I 
don't know how anyone could tell for sure, but the companies 
can represent that hopefully in the next panel.
    Mr. Burgess. Maybe we will go there with the next panel.
    Dr. Shuren, have any of the companies ever been denied 
marketing devices requiring approval?
    Dr. Shuren. They haven't come to us to have their devices 
approved.
    Mr. Burgess. So it has not even been on the radar screen?
    Dr. Shuren. They haven't. In years past when the tests were 
first being developed, with some of the companies we actually 
suggested that they come to us if they want greater 
clarification. Back then they were making much simpler claims. 
They never came to us with any data or information.
    Mr. Burgess. Now, Mr. Kutz, do you feel it would be 
important to associate--you have four companies that were 
blinded up on the slide. Do you think it would be important for 
this committee to know--to unblind those so we know which 
companies provided which results?
    Mr. Kutz. Of the four?
    Mr. Burgess. Yes.
    Mr. Kutz. If you like, yes.
    Mr. Burgess. Maybe that information could be made available 
to the committee.
    I am advised if you know, you may state it.
    Mr. Kutz. All right, of the four companies described as 
Number one, two, three and four in our report, number one is 
23andMe, two is Decode Genetics, three is Pathway Genomics, and 
four is Navigenics.
    Mr. Burgess. And, again, you can look at the glass as half 
full. So I would definitely take the best results you got of 
the four.
    Mr. Kutz. I slept better last night, thank you.
    Mr. Burgess. I knew you would. I did that for your benefit. 
And your testimony notes that company two claimed that testing 
for more markers is probably more accurate. If the company 
tests for more markers, that increases their accuracy. Can you 
comment on that?
    Mr. Kutz. Yes. Well, we did visit with the companies. They 
don't know exactly what we did at this time, but they did each 
claim that they weren't surprised that we got different 
results, and the differences were attributable to the number 
and type of markers that they looked at. So several of them 
claimed they were more reliable than the other ones. But they 
all were not surprised, from what I understand from the 
interviews.
    Mr. Burgess. Are we are going to get to go a second round? 
I will yield back.
    Mr. Stupak. Chairman Waxman, please.
    Mr. Waxman. Thank you, Mr. Chairman.
    Dr. Shuren, you believe that these are medical devises that 
should be regulated by the FDA. Is the basis of that the claims 
made by the Web sites and the producers of these tests?
    Dr. Shuren. Yes, that is correct, so claims for risk of 
cancer or sensitivity to drugs.
    Mr. Waxman. OK. Now, what do they have to do to stay in 
business if they are considered medical devices?
    Dr. Shuren. Well, we hear from them the particular claims 
they in fact they want to make, and for some of these they are 
going to have to come to us and submit pre-market data.
    What we have done with companies in the past who may be 
marketing a test already who need to get FDA clearance and 
approval, we may allow them, if they are ready to come in the 
door with a submission and they have got the data and there 
isn't a risk to patient safety, we may allow them to continue 
to market for a short period of time to allow us to look at 
data and make a determination. But if they are not prepared to 
do that or there are concerns about patient safety, then we 
would have them no longer market that test.
    Mr. Waxman. I assume that the science is not advanced to 
the point where they can say you are going to get this disease 
or you are not going to get this disease. They are looking at 
the trend, the likelihood.
    Now, if they have a scientific ability to say that it is 
more likely than not, isn't that helpful to the consumer and 
how would they be able to get approval for that kind of a claim 
from the FDA when they can't show the absolute scientific 
backing for a claim like that?
    Dr. Shuren. Well, what is critical here is, first of all 
that information has to be accurate, and there is a lot of 
questions now about the accuracy of that information, as you 
saw from what GAO showed, and it has been in some published 
reports already that in fact the companies disagree.
    One of the companies even in letters to us admitted that 
different genetic testing companies can report inconsistent 
results even when based on tests with proven analytical 
validity, and they go through all the different reasons. 
Because they are looking at the data, they are making their own 
determinations on where to make cutoffs on the science.
    Another company on their Web site has said many of the 
genetic discoveries that we report have not been clinically 
validated and the technology we use, which is the same 
technology used by the research community, to date has not been 
widely used for clinical testing.
    So, in terms of what we are going to want to see, is not 
only is it accurate, but if we are going to give information to 
patients, is that information truthful, not misleading, are 
they going to understand it, what is going to be the emotional 
impact with that patient? Is it information they are going to 
be able to handle by themselves, or is it really information 
they need a physician or genetic counselor to provide back to 
them? We are going to look for data to answer those questions.
    Mr. Waxman. That is an interesting point, because you are 
saying not only does the information have to be accurate, but 
FDA is going to evaluate how the information is going to be 
received.
    Now, let's say there is a maternity test, someone wants to 
markets a maternity test. I assume that requires FDA approval, 
pre-marketing approval. Did FDA in reviewing those tests look 
at how the information would be received?
    Dr. Shuren. When we do look at tests that are over-the-
counter, so here the test is simple enough that the patient can 
use it and test themselves and they can understand and use the 
results. So the answer is for these tests where there are 
concerns about how the patient will----
    Mr. Waxman. But I asked you about a specific one.
    Dr. Shuren. Well, for maternity, maternity may not be 
actually a device claim.
    Mr. Waxman. As I understand a paternity test, a paternity 
test is not something to that would be approved by the FDA. Why 
is that?
    Dr. Shuren. That is correct. Because if it is using, for 
example, as evidence in a court case for determining if you are 
the father of the child, that is not a medical claim. However, 
there may be things about paternity. If you are saying that, 
well, we are looking at paternity for making a decision of your 
risk for heart disease, then you are making a medical claim.
    Mr. Waxman. Now the consequence of some of these lines, for 
exactly where you draw it, for a company to get a medical 
device approval would mean what, they would have to do lots of 
tests, it will cost them lots of money, and I suppose that some 
of these companies won't be able to stay in business. Is that a 
fair statement?
    Dr. Shuren. Well, it depends upon what they are going to 
actually test for and to show that it is actually accurate, you 
are measuring what you are supposed to. For example, this is 
the genetic profile we are looking for. Much of that is bench 
testing.
    Mr. Waxman. Let me ask you this question, because I have 
just a few seconds left. If the requirement for the test, and 
this is yet to be determined by FDA in talking with these 
companies, if the cost of doing the test to get pre-market 
approval by the FDA would turn out to be so expensive that the 
companies could not stay in business and there were no 
companies in business, is that a good result? Does the FDA 
think is it is a good idea not to have any of these companies 
doing this kind of this work?
    Dr. Shuren. We think that it is good to have companies 
doing the work if the tests are accurate, they are supported by 
sound science and they are understandable. We don't think it is 
good to be giving misinformation to patients.
    Mr. Waxman. Thank you. Thank you, Mr. Chairman.
    Mr. Stupak. Mr. Kutz, if I may, you identified the four 
companies that you dealt with in your investigation. The 
company you bought the supplements from? That was not one of 
the four?
    Mr. Kutz. Right. That was, again was GeneWise Life 
Sciences.
    Mr. Stupak. OK. Mr. Griffith for questions, please.
    Mr. Griffith. Just a couple of comments. I think that 
Chairman Waxman is making a very good point. I don't think that 
the companies that are in question here would, if they 
disappeared tomorrow, would impact the scientific community and 
our desire to do research into genetics. I don't think that 
that is--I don't think that is really a discussion here. I 
think the discussion is that whether you are a Ph.D. or a 
physicist or you are a farmer with a limited education, your 
medical IQ levels out when someone says ``cancer'' or 
``Alzheimer's'' in front of you, and you do not have the 
ability to interpret these results, much less have a follow-up 
as to what is necessary. As far as prostate cancer is 
concerned, we know that if a man lives long enough, he will 
develop prostate cancer.
    This is all bogus. This is nothing more than the snake oil 
salesman revisited again in a high-tech community and in a 
high-tech way. I think that the proof is in many of the 
discussions that you have had with these companies, and it is 
very difficult to protect the public from itself and its desire 
to be healthy.
    So I think this committee is doing something that I think 
is very, very important, that we do impose significant 
strenuous regulations on these laboratories and what they are 
doing and what they say they are doing.
    It reminds me of a story that they used to tell about the 
snake oil salesman. He had two medicines, one was High 
Popalorum and one was Low Popahirum. High Popalorum was taken 
from the bark of the tree from the limb down, and Low Popahirum 
was taken from the bark of the tree from the root up. They were 
both good, but they were different. And I think what we are 
seeing here is the High Popalorum-Low Popahirum story with a 
large check attached to it on a credit card or what have you.
    The other thing is this is nothing more than a lead-in to a 
marketing effort. Anyone that takes the time to find out 
whether they have got Alzheimer's is already concerned about 
it. They go on the marketing list for medications, vitamins, et 
cetera, and they begin to get bombarded with mail. They 
probably say, well, how did anyone know I was interested in 
Alzheimer's? The lists are being sold. Breast cancer is the 
same way. Most malignancies are the same way.
    So I think we are on to something here as far as what we 
need to do for the public. I yield back the balance of my time.
    Mr. Burgess. Would the gentleman yield? I thank the 
gentleman for yielding.
    I do just want to point out that this science has evolved 
so rapidly in just a few short years that I have been here on 
this committee, and I can remember Dr. Zerhouni talking to us 
sitting at this very witness table, his last public appearance 
in front of this committee, talking to us about the single 
nucleotide polymorphisms that are being used as these tags to 
ascertain the risk factors.
    He put a slide up on the board that showed the number that 
were available in 2003 and then went through the years. And by 
the time we got to 2008, which was the year then, the entire 
slide was filled up with these. So there has been a dramatic 
expansion of the information that is available.
    A field trip that I took to the National Institutes of 
Health in 2003, I went to a room where they were doing the 
testing for the genetic tag for Type 1 or Type 2 diabetes, now 
I don't remember which it was. It was an enormous room full of 
people at the bench testing. They were linked in on the 
Internet to at least two other labs located in other places in 
the world that I was told were equally as large where people 
were working away around the clock at doing this sequencing.
    Last spring, I went to the NIH and I saw a machine that was 
the size of two file cabinets and it was doing the same work of 
three large labs from just a few years ago and doing it much 
faster, and I suspect with at least as great or if not greater 
accuracy.
    So, Dr. Shuren, this knowledge is going to evolve at a very 
rapid pace. And I would just restate the question that I stated 
in my opening statement, are you ready, is the FDA ready for 
what is going to be delivered to it by the NIH and private 
companies and researchers across the country?
    Mr. Waxman. Would the gentleman yield to me in the few 
seconds he has remaining?
    Mr. Burgess. I had asked a question to the witness and I 
was hoping to get a response.
    Mr. Stupak. Let's get a response, and then we will let the 
chairman follow up.
    Dr. Shuren. It is a great question, and the answer.
    Mr. Burgess. That is why I wanted a response. It was a 
great question.
    Mr. Waxman. He wanted a phrase.
    Dr. Shuren. And I am sure your question will be just as 
great.
    So we held a public meeting on June 30th to get at this 
question. We are thinking, and I will tell you our initial 
thinking is really an out-of-the-box approach on genetic 
testing.
    We have two issues. Does the technology being used, is it 
accurate? And as you mentioned, you could be looking at 
hundreds of thousands of these single nucleotide SMPs, and you 
are not going to have a validation that looks at every single 
one of them. So we are looking at maybe there would be a 
subset. And if you could show, you could demonstrate you are 
accurate with that subset, that is good enough and we would 
trust you on all the rest of the things you are looking at.
    The second piece goes to then when I test for that profile, 
do I really know that it is detecting or predicting the disease 
it is supposed to detect and predict. And that is where the 
science really is evolving.
    What we are thinking about is FDA along with NIH pulling in 
from the health care community, pulling in from patient groups, 
actually sit there going through the science, and when we set 
the standards of what is good enough and when it is ready, 
allow those claims. The companies then would not have to come 
back in the door with a new application. We would say you are 
already a validated test. You can now make this claim.
    That would actually be a way to allow for a lot of tests to 
be out there, and we would be able to sort of go through that 
science with a lot of experts to then allow for those claims. 
And that would actually be a much less expensive way of doing 
it for these companies as well.
    Mr. Burgess. And that could tie into the disease registries 
that we are building as a result of work in this committee.
    Thank you, Mr. Chairman. I yield back.
    Mr. Stupak. The gentleman has a question?
    Mr. Waxman. The gentleman's times has expired. Others are 
waiting to ask their questions.
    Mr. Stupak. Mr. Griffith?
    Mr. Griffith. One quick comment. In addition to the 
disease, one of the things that is going on is most of our good 
legitimate genetic labs are wide open information. They share 
it. It is a real scientific endeavor. We know that we can 
expose 100 of our troops to a traumatic event in Afghanistan 
and Iraq and only 10 percent will develop post-traumatic stress 
syndrome. We believe there is a genetic tendency for that.
    So a lot of the research that we are doing is unrelated to 
the snake oil concept, but it is ongoing and it is certainly 
not part of this discussion.
    So I yield back.
    Mr. Stupak. Remember, in the last 48 hours this committee 
went from Gulf Oil to snake oil. So we are on top of our game.
    Ms. DeGette for questions, please.
    Ms. DeGette. Thank you, Mr. Chairman. I would like to 
follow up on the points that Mr. Burgess was just making, 
because I am interested to know, Dr. Shuren, if in fact--in 
your written testimony you say the FDA has cleared a number of 
genetic tests since 2003, and I am wondering if in your opinion 
we have the technology to be able to determine that these mail 
order type of tests can be accurate and can be approved?
    Dr. Shuren. So there are two parts of accuracy. The 
technologies used today are getting better and better and some 
of them are pretty good. But in terms of what the results mean, 
for many of the claims being made by these companies, the 
science has not yet sufficiently evolved.
    Ms. DeGette. So you do the technology, you can do the 
tests, but it is the interpretation of the tests?
    Dr. Shuren. That is right. The technology is moving faster 
than the science behind the interpretation of the tests.
    Ms. DeGette. So given that, do you think that it is likely 
under the process you have described the FDA will be able to 
approve some of these mail order testing?
    Dr. Shuren. It is possible. We are going to have to wait 
and see what data they have, what claims they make. I think 
some of those claims they may not be able to make today. Some 
of them maybe they would be able to make. But it is going to be 
based on sound science.
    Ms. DeGette. And do you think that primary care physicians 
are adequately trained to interpret and assess and make 
recommendations based on these tests at this point?
    Dr. Shuren. I am not an expert in that, but I will tell the 
Secretary's Advisory Committee on Genetics, Health and Society 
concluded that physicians generally are not well prepared to 
provide that kind of counseling.
    Ms. DeGette. Is that going to be part of the FDA's 
consideration as well?
    Dr. Shuren. Yes.
    Ms. DeGette. I wanted to ask you, Mr. Kutz, because 
obviously your testimony was compelling, but the audio clips 
were even more compelling of what people were being told by 
these companies. One thing that struck me was how little regard 
was shown in that audio clip for patient privacy. The woman 
says I want to have, I guess as a wedding gift or something, I 
want to have my fiance tested, and the company said, well, that 
is a super good idea and we have done that with others.
    I know that both of the companies that did that have 
specific policies prohibiting the sharing of genetic 
information with a third party. Were you aware of that?
    Mr. Kutz. Yes, we knew that they had policies contrary to 
that. That is why we were testing to see if they would actually 
say no, we don't encourage that or we are not going to do that 
if we know about it.
    Ms. DeGette. And do you think it was a problem with the 
employee on the phone not knowing what the company policy was 
and that training within that company could have helped that?
    Mr. Kutz. We didn't talk specifically to anyone about that, 
so I don't know. But I believe the two companies will probably 
be on the next panel.
    Ms. DeGette. And what were those companies?
    Mr. Kutz. Let me get it for you. I believe it is Pathway is 
one and Navigenics is the second.
    Ms. DeGette. Thank you. Here is my other question. I am 
wondering if you know if these companies went out of business 
or any of these companies went out of business that held this 
genetic data. Is there some kind of a system right now for what 
would happen to that data if the companies went out of 
business?
    Mr. Kutz. I don't know that.
    Ms. DeGette. Dr. Shuren, is that part of what the FDA is 
considering when it decides whether to approve these tests?
    Dr. Shuren. It is not an area that we have jurisdiction 
over, for the most part. If we are dealing with labs, then CLIA 
does have certain protections in place. Covered entities under 
HIPAA. But you may be dealing with companies that fall outside 
of that scope, and that could be a problem.
    Ms. DeGette. I am going to yield my remaining minute to the 
Chairman, who has another question.
    Mr. Waxman. You are very kind. Thank you.
    I guess the question that I just want to raise, and we will 
have the witnesses on the second panel that can be helpful in 
answering this question, but do these companies have 
researchers that are adding to the information that will help 
us have these breakthroughs for learning more about propensity 
to disease and how to make medicine more personal? Do they have 
researchers? Are they adding to the scientific knowledge? Or 
are they, as the gentleman from Alabama seems to suggest, 
charlatans, and if they are all closed down, then so be it, 
they don't really serve a useful purpose.
    I don't think the public ought to be misled. I don't want 
people to be abused. So I think there ought to be some 
scientific standards. But I think we have to look at what the 
consequences will be if they have to go through a process at 
FDA that may be so expensive that they can't survive it and 
what the loss will be.
    I just want to raise that question, more for the second 
panel, unless either of you have an idea, an answer to it. But 
otherwise it would go to the second panel.
    Mr. Kutz. I can answer it a certain way. I don't believe 
these four companies are involved with fraud. I don't believe 
this is fraud necessarily, because I think they believe what 
they are doing. I don't think they believe they are 
intentionally deceiving anybody.
    Whereas I believe this is fraud (indicating). So I just 
want to make that distinction. I didn't necessarily answer your 
question directly, but there is a difference between companies 
that believe they are doing something good and right versus 
ones that know they are deceiving consumers.
    Mr. Waxman. That product if sold without a claim can be 
sold without any FDA review.
    Mr. Kutz. Yes, and it is being. There are lots of 
companies.
    Mr. Waxman. The question is, there is a claim by one of 
these direct-to-consumer advisories make that something for 
which FDA would review, be required to review it. And I have a 
serious question about that, again, these lines that we are 
drawing. So the product that you are worried about that could 
be fraudulent could be sold freely, but the people that make 
the claim, if they just couched it another way, may avoid any 
regulation.
    Mr. Kutz. Right.
    Mr. Waxman. Thank you.
    Dr. Shuren. I would add in terms of--from the information 
we know they are not doing their own research on the genetic 
profiles but they are interpreting the studies that have been 
performed by others.
    I would raise, regarding companies going out of business, 
there is another side to this. The failure of FDA to regulate 
for many of these tests has created a disincentive for 
traditional manufacturers to get more involved in this area, 
and I think that stifles innovation as well. We need to 
consider it. Smart regulation can enable innovation.
    Mr. Waxman. Thank you.
    Mr. Stupak. Ms. Christensen, any questions, please?
    Mrs. Christensen. Thank you, Mr. Chairman.
    Mr. Kutz, you said in your testimony that many of the 
studies on which the genetic testing companies based their risk 
predictions include only data for people of European ancestry. 
I understand that GAO sent DNA samples with altered ethnicity 
information to four genetic testing companies.
    Can you explain how exactly that worked, what altered 
ethnicities were submitted in your investigation, and did the 
genetic analyses you received differ based on what you told the 
companies about ethnicity?
    Mr. Kutz. Yes. That is another interesting angle to this, 
and I will just use myself since I was one of the donors. In 
one of my cases, case number one for me, I was a 48-year-old 
Caucasian, et cetera. In the other case, I was a 69-year-old 
African American man. So with respect to that, the results I 
got back in two of the cases were identical, but there was like 
a footnote saying but these results really don't mean anything 
because you are comparing your African American to people of 
Eastern European descent, et cetera. The other two, the results 
were different.
    So they were apparently comparing me as an African American 
against other African American men, or perhaps just African 
Americans, I am not sure. And those were different, and there 
were a lot less of them. In other words, certain diseases they 
weren't able to compare.
    So it was a combination of I think misleading--they all 
disclosed something about it, but at the end of the day we got 
different results for two and the same results for two.
    We asked for refunds, and two of the four gave us refunds 
because we felt we had been ripped off on that as a minority.
    Mrs. Christensen. OK. That kind of responded to my other 
question. Which companies gave the refund and which ones 
didn't?
    Mr. Kutz. The refunds were Decode and 23andMe. And Pathway 
and Navigenics did not give us refunds.
    Mrs. Christensen. Do you feel that--did the companies say 
up front, do they let the customer know up front--you do have 
to put your ethnicity on it.
    Mr. Kutz. All of them I believe ask for age and 
ethnicities. Some asked for additional medical information on 
your history.
    Mrs. Christensen. And do the companies say up front, well, 
we don't have a lot of data for minorities because our data 
pool really comes from people of European ancestry? Is that 
information provided up front?
    Mr. Kutz. It is disclosed, I believe, but not necessarily 
in a prominent way.
    Mrs. Christensen. And in the case of minority customers, do 
you feel that the marketing is misleading and deceptive?
    Mr. Kutz. Yes. I believe that there should be much more 
prominent disclosure. If someone says they are African American 
or Asian, which were our two scenarios, they should be told 
very clearly before they take their credit card information 
that you are not going to get the same results as if you are 
Caucasian.
    Mrs. Christensen. I think it is appalling that the 
companies would ask about their customer's ethnicity at the 
outset, and despite knowing immediately they can't provide the 
customer with the full results, still run the tests and charge 
the same price.
    Let me ask Dr. Shuren a question, also. The reason that FDA 
can--and it sort of follows up on the chairman's question. The 
reason that you have any jurisdiction over these tests is 
because they qualify as a medical device because of some of the 
claims that they make, is that right?
    Dr. Shuren. That is correct.
    Mrs. Christensen. So the company can just change their 
claim and fall below the threshold, can't they not, and then 
what recourse do we have to have any oversight whatsoever?
    Dr. Shuren. So if they make claims, they are not making 
medical claims at all, but they are engaging in fraudulent 
practices, then we would be engaging with FTC. And that is one 
of the reasons too, the information that GAO provided, we have 
shared that with them at all. While we may not have authority 
over everything, our other sister agencies have additional 
authorities and we work with them in such situations.
    Mrs. Christensen. And I know that in answer I think it was 
to Ms. DeGette's question, I don't remember who asked it, but 
do primary care physicians, of which I am one, have enough 
expertise to be able to interpret the results? Despite your 
answer, we are talking about direct-to-consumer sales of these 
tests. Would the FDA or GAO's position based on your 
investigation be that these tests should be only done if 
ordered by a health care professional?
    Mr. Kutz. Well, the genetic experts we spoke to said that 
most doctors would not be able to interpret--I think it is 
consistent what Dr. Shuren said, that the HHS studies showed. 
Our experts in genetics told us the same thing.
    Mrs. Christensen. So who would interpret it? I mean, what 
is the use of the test?
    Mr. Kutz. I mean, I can speak for myself, because I am one 
of the donors actually, and I showed you only the chart for 
three very serious conditions or diseases, I got three 
different answers. So I am still confused about that.
    Dr. Shuren. And for some of the tests you will get a result 
and who knows what to actually do with it. In other cases, 
people may be making a decision even it is on lifestyle. If you 
tell them they have low risk for diabetes, they may not have 
low risk and that person may be obese. A physician would say, 
you are obese. You have unhealthy habits. You are actually at 
high risk for diabetes, regardless of what your genetic test 
says. Yet that person may decide I can have my cake and eat it, 
too.
    Mrs. Christensen. So if they had a provider, a health 
professional, nurse, nurse-practitioner, physician assistant or 
physician involved in the process, they would be better off?
    Dr. Shuren. Yes.
    Mrs. Christensen. Thank you.
    Thank you, Mr. Chairman.
    Mr. Stupak. Thank you.
    Let me just follow up a little bit, if I may. These 
companies, Dr. Shuren, the FDA contacted them with letters, 
some in 2009, some in 2010. The FDA invited them to come in to 
say if you are going to do this type of testing, come on in, 
lets's talk about it, is that correct?
    Dr. Shuren. That is correct.
    Mr. Stupak. And no one took you up on that offer?
    Dr. Shuren. The offer we made now, the companies are now 
scheduling to come in. We have met with one company once and 
they are coming in again. We have met with a second company and 
they are going to come back and talk to us.
    Mr. Stupak. But these companies, they know darn well that 
FDA has oversight of what they are doing and they are trying to 
avoid FDA regulation, are they not?
    Dr. Shuren. Well, they should know that we have oversight 
over them. It would be a good question for the next panel.
    Mr. Stupak. Well, there is a binder right there in front of 
you, that binder. Go to Exhibit No. 8, if you would, in there. 
In there, in one of the letters, all these companies before us, 
23andMe, Navigenics, Pathway Genomics Corporation, and Decode 
Genetics, they have all received letters from the FDA, have 
they not?
    Dr. Shuren. Yes.
    Mr. Stupak. OK. So if you go to Tab 8 there, this is a 
document dated--it is an e-mail actually--July 1, 2009, it is 
from a Pathway employee who is discussing the advantages and 
disadvantages of using a swab for DNA collection. You can see 
in there they have the pros and cons. One of them they list is 
under the pros, the employee says for using swabs is to ``avoid 
issues of the FDA regs regarding device manufacture and 
licensure of collection container.''
    So they are trying to avoid FDA regulation. They think if 
they use a swab, they avoid the FDA. Do they avoid FDA 
regulation using a swab?
    Dr. Shuren. No, not necessarily. And I think this was for 
Pathway Genomics, did you say?
    Mr. Stupak. Correct.
    Dr. Shuren. So Pathway Genomics isn't even--if they are 
trying to argue on a laboratory developed test, and when I get 
a collection sample I have to use something that is approved 
and cleared by the agency for that use, they are not a lab 
developed test. Their genetic test they use, they buy from 
another company. That is our understanding. If that is not the 
case, they can demonstrate to us otherwise.
    Mr. Stupak. OK. So they have the lab. But also when they 
send the results, like to Mr. Kutz, they are making a medical 
decision or diagnosis, are they not?
    Dr. Shuren. Yes.
    Mr. Stupak. And you need a license for that, do you not?
    Dr. Shuren. That is something that goes, I hate to do it 
this way, but for State law, it is sort of who can actually 
practice medicine. If they are engaging in the practice of 
medicine. But regardless, they are acting as a manufacturer 
under FDA law.
    Mr. Stupak. Then if they send you a bag of supplements 
there for $140, now they are actually practicing medicine, 
because they say bag of supplements might lower my blood 
pressure, correct?
    Dr. Shuren. They would certainly be acting as a drug 
manufacturer.
    Mr. Stupak. OK. Go to document, Exhibit No. 2, and this is 
a document from 23andMe that outlines a conversation between 
two employees about CLIA. We have heard by CLIA, which is the 
Clinical Laboratory Improvement Amendments, which is a law 
administered by the Centers for Medicare and Medicaid, that 
regulates diagnostic lab testing on humans in order to ensure 
reliability of the tests.
    If you look at Exhibit No. 2, it says in there, Alex says, 
``CLIA is so useless for a lot of things it sees. It ensures 
that all,'' and they have some colorful language in there, 
``are well documented and validated, but doesn't actually 
prevent them.''
    So, Dr. Shuren, I understand that the CLIA tests whether 
the lab test is reliable, but does the CLIA process have any 
role in protecting consumers from being confused or misled 
about diagnostic value in these genetic testings?
    Dr. Shuren. No, CLIA does not address that.
    Mr. Stupak. OK. Does the CLIA process make sure that the 
direct-to-consumer genetic test does what it purports to do?
    Dr. Shuren. No, it doesn't.
    Mr. Stupak. What kind of regulatory scheme then would 
address both the reliability of the test and ensure the safety 
and the efficacy of these tests?
    Dr. Shuren. What you need is both FDA oversight and CMS 
oversight under the Food and Drug Cosmetic Act and under CLIA.
    Mr. Stupak. As the investigation has shown, there are some 
with the direct-to-consumer genetic testing market that will go 
to great lengths to avoid government regulation. So we really 
hope that this hearing provides more balance and demonstrates 
why stronger and more diligent regulation is necessary.
    You also mentioned CFTC, or I am sorry, FTC, the Trade 
Commission, would also have a role in this?
    Dr. Shuren. They may. When we got the results the other 
day, we shared it with them. We are going to have follow-up 
dialogue.
    Mr. Stupak. Mr. Kutz, you have something you wanted to add 
on this?
    Mr. Kutz. Well, we referred these to FTC, too, for 
potentially deceptive marketing practices.
    Mr. Stupak. OK. Mr. Burgess, questions?
    Mr. Burgess. Dr. Shuren, in a regulatory environment for 
these tests, would they be Class 1 or Class 2 devices?
    Dr. Shuren. It depends on the claim. Many of these claims 
that are medical claims look to be more. Some of them look like 
Class 3, some would be Class 2. We would need to get the 
specifics on them.
    Mr. Burgess. So Class 3 or Class 2 would be eligible for 
the tax under the health care bill that we passed and signed 
into law a few months ago, correct? Have you relayed this 
information to the Congressional Budget Office, because they 
are always looking for scores and savings on that patient care 
bill that we passed.
    Let me just ask you a question, Dr. Shuren, regarding the 
regulatory pathways. Is the Food and Drug Administration at the 
present time looking at the development of new regulatory 
pathways for things that are just on the horizon and perhaps a 
few steps over the horizon?
    Dr. Shuren. The answer is yes. I think the approach I laid 
out on genetic testing is an entirely different way of 
approaching technology. FDA has done this over the years. As we 
deal with new sciences, we have a lot of flexibility under our 
existing authority and we adapt it to new technologies. I think 
this is one area where you are going to see us do that.
    Mr. Burgess. You know, one of the disappointing things 
about this here has been that we have done absolutely nothing 
on a Federal budget at the congressional level. We have had no 
hearings, we have not had the ability to have anyone in and 
talk to them about their views and estimates for their agencies 
for the fiscal year that is just around the corner now.
    What can you tell us about the budget that you have to 
provide this new regulatory environment that is clearly going 
to be required? We are dealing with one small aspect of it 
today, but there are a lot of things that are just over the 
horizon in regenerative medicine, in the types of cancer 
therapy that may be available, where again your target 
population is a single patient and it is tough to do a 
randomized clinical trial on that, a population of one.
    So what is the budgetary outlook for your department as far 
as this any regulatory environment?
    Dr. Shuren. Well, that is one where we are working through 
the usual budgetary procession to handle. I will say as we gear 
up, as we see more diagnostics coming down the pike, we do a 
re-look at our existing list of diagnostics, and for some that 
are moderate risk we better understand, we sometimes move to 
down-classify them into Class 1, which means we don't do a pre-
market review.
    We are doing such a review right now, and when we do that 
and it is appropriate to down-classify, we free up resources 
that we can then apply to new technologies coming in the door.
    Mr. Burgess. Now, bear in mind, when you down-classify, 
that is going to take something off the tax rolls for the 
PPCRA, or whatever the dang thing is. So there will be a 
Congressional Budget Office score to that. And I am being a 
little bit lighthearted, but obviously we have an obligation, 
we will be looking at reauthorization of the Food and Drug 
Administration in just really a very short period of time. I 
can't believe it has already come back around again so quickly.
    But I think it is an important time for us to look at how 
you all are doing with establishing the FDA, that will be 
required to meet the challenges. Again, we are looking at one 
tiny little part of it this morning, and it is terribly 
interesting and terribly important, but there are a lot of 
things on the horizon out there that the 20th century FDA was 
ill-equipped to handle, and the FDA has to be able to handle 
the things that are going to occur in the 21st century with the 
speed of research and development.
    I have been concerned for some time that we put $10 billion 
into the NIH in the stimulus bill, but we didn't do anything 
for the FDA. Now, assuming that those dollars we have invested 
in research at NIH are going to lead to deliverables and 
products, are you all able to keep up with getting those things 
out to the patient population that may need them, or was the 
money spent on research really never intended to get to a 
deliverable anyway, we were just spending money to spend money.
    Now I don't know the answer to that question and I have 
never been able to get a satisfactory answer from anybody at 
the FDA. Again, we never had any budgetary hearings.
    So what is your sense on this? Do you have the tools that 
you need? Are you going to be able to talk to us at some point 
about what is over the horizon and what is required to have a 
good functioning 21st century FDA?
    Dr. Shuren. I think it is a discussion we would be happy to 
have, to talk about our thoughts on what is coming down the 
horizon, our thinking about what it may take to be well 
prepared.
    Mr. Burgess. I can only pray that our chairman will invite 
you in to discuss that some day, because it has been lacking 
this past year and it has been an omission that is significant, 
as we are seeing here this morning.
    Thank you. I yield back the balance of my time.
    Mr. Waxman [presiding]. The gentleman's time has expired.
    Ms. DeGette.
    Ms. DeGette. I don't have any further questions.
    Mr. Burgess. Can I just ask one last question on the issue 
of genetic counseling? Under whose regime does that fall? 
Clearly the phone calls that Mr. Kutz was playing for us, these 
were telemarketers giving genetic counseling. That is so 
inherently dangerous that regardless of anything else we decide 
this morning, that has got to stop. So who is the cop on the 
beat for that? Who pulls the plug on that activity or makes 
these companies understand that this has to cease and desist 
and you need to hire genetic counselors to give genetic 
information?
    Dr. Shuren. Well, in some respects we have a certain 
responsibility, so we may decide these are tests that actually 
can't be provided directly to consumers, it is actually test 
results that have to go through a health care professional. If 
it is something where we decide that it could be provided 
through a genetic counselor, and we have done that in the past, 
then the appropriateness of those counselors and their 
credentialing I believe is handled at the State level.
    Mr. Burgess. Thank you.
    Mr. Waxman. Thank you very much. We appreciate your 
testimony. We look forward to talking to you further about this 
issue.
    Mr. Kutz. Chairman Waxman, can I correct something real 
briefly before the second panel?
    Mr. Waxman. Yes.
    Mr. Kutz. I had said before I think that I think the 
refunds for our minorities were Decode and 23andMe. They were 
really Decode and Pathway gave us the refunds. Just so if you 
are asking questions of the second panel, that that is the 
correct answer. I apologize for that.
    Mr. Waxman. Thank you.
    I would like to now call forward our second panel of 
witnesses.
    We have Dr. James Evans, Editor-in-Chief, Genetics in 
Medicine and Bryson Professor of Genetics and Medicine at the 
University of North Carolina at Chapel Hill; Ms. Ashley Gould, 
General Counsel, 23andMe; Dr. Vance Vanier, President and CEO 
of Navigenics; and Dr. David Becker, Chief Scientific Officer 
with Pathway Genomics Corporation.
    I want to welcome you to our hearing today. We appreciate 
your being here. It is the practice of the Oversight 
Subcommittee to have all testimony given to us done under oath, 
and so, if you would, now that you have sat down, please rise.
    You are advised that you are entitled to be represented by 
counsel during your testimony. Do any of you wish to have 
counsel assist you during your testimony?
    Ms. Gould. Yes.
    Mr. Madigan. Michael Madigan of the Orrick law firm, Your 
Honor. Pleased to be here.
    Mr. Waxman. I haven't been addressed as ``your honor'' in 
quite a while. Thank you.
    [Witnesses sworn.]
    Mr. Waxman. Let the record indicate that each of the 
witnesses answered in the affirmative.
    Dr. Evans, why don't we start with you. There is a button 
on the bottom of the mike. We will have a clock running for 5 
minutes. We would like to ask you to keep to that time.

  TESTIMONY OF DR. JAMES EVANS, EDITOR-IN-CHIEF, GENETICS IN 
MEDICINE, BRYSON PROFESSOR OF GENETICS AND MEDICINE, UNIVERSITY 
    OF NORTH CAROLINA AT CHAPEL HILL; ASHLEY GOULD, GENERAL 
    COUNSEL, 23ANDME; DR. VANCE VANIER, PRESIDENT AND CEO, 
   NAVIGENICS, INC.; AND DR. DAVID BECKER, CHIEF SCIENTIFIC 
             OFFICER, PATHWAY GENOMICS CORPORATION

                  TESTIMONY OF DR. JAMES EVANS

    Dr. Evans. Mr. Chairman and members of the committee, thank 
you for inviting me to testify.
    Mr. Chairman, I ask that my prepared remarks be submitted 
for the record.
    I am a physician and scientist who specializes in genetics. 
I conduct research on the genetics of cancer, and I am Editor-
in-Chief of Genetics in Medicine, the journal of the American 
College of Genetics. But first and foremost, I am a physician. 
I am a board certified internist with a general medical 
practice and a board certified general geneticist who sees 
patients with genetic disorders. I regularly utilize genetic 
testing in my practice.
    Advances in technology hold great promise for a future of 
personalized medicine. We should encourage individuals to be 
the primary directors of their own health care. Truly 
participatory medicine is a worthy goal and people should have 
access to the information contained in their own genome.
    But it is critical that such information be of high 
quality, that individuals receive accurate advice about the 
meaning of that information, that their privacy be protected, 
and that claims concerning those tests comport with reality.
    Unfortunately, this is not always the case at present. One 
egregious problem is the gap between claims by the providers of 
such services and the value of the information actually 
imparted.
    Most purveyors of DTC genetic testing appeal explicitly to 
its alleged medical value. We hear that genomic analysis allows 
one to ``take control of your health future.'' Yet on each page 
of every report is some variant of the following disclaimer. 
``Information provided is not intended as nor does it provide 
medical advice, treatment, diagnosis, or treatment 
guidelines.''
    The explicit health claims and the small print disclaimers 
cannot both be true. Indeed, they are not. The disclaimer is 
correct. Such information by and large lacks medical 
significance. This would be true even if we understood how to 
interpret such results which, as clearly demonstrated by the 
literature and by the recent GAO investigation, we do not. The 
gap between claims and reality should be closed, and this could 
be accomplished in part by simply enforcing existing standards 
promulgated by the FTC.
    But while the vast majority of DTC tests are of merely 
entertainment value, some have serious, indeed potentially life 
changing, medical consequences. Thus, having signed up for 
innocuous information about her ear wax consistency or possible 
food preferences, a woman may also discover via a company Web 
site that she should consider bilateral mastectomy and removal 
of her ovaries. Startlingly, the recipient of such information 
from at least one major purveyor has no recourse to even talk 
with a qualified professional about her result. It is dangerous 
to allow the conflation of entertainment with medicine.
    With regard to quality, if genomic information has true 
medical value, then it is only logical that its quality be 
insured like that of any other medical test. I applaud the 
recent move of the FDA to take a risk calibrated approach to 
regulation, a timely endeavor in light of the recent mix-up of 
87 samples by one major DTC company.
    Protecting privacy is also critical. A minute sample of 
your DNA can differentiate you from every human who has ever 
lived. What do we do when a company goes bankrupt and ownership 
of your uniquely identifying genomic information might suddenly 
become the property of a venture capital firm? We need clear 
and enforceable guidelines for how such information is handled 
by its inevitably unpredictable owner.
    Regulation does not mean proscription. We can embrace an 
exciting future in which the public has access to its genome in 
a way that includes reasonable risk calibrated regulation. 
Indeed, the interests of companies and public health are fully 
aligned, since both long-term business interests and the 
public's health will thrive only when tests and the claims 
about those tests can be trusted.
    No one is more excited about the future of genomics than 
me. You can probably tell that by my questionable choice of tie 
for this hearing. I welcome the entry of responsible 
entrepreneurs into this field. Medicine has plenty to learn 
from innovative companies.
    I agree that people deserve access to the information 
contained in their genomes. But as a physician who deals with 
these issues daily, I do not feel it is paternalistic to simply 
maintain that they also deserve an honest accounting of what 
such information means and the assurance that it is derived in 
a manner that ensures quality, reliability and privacy.
    Thank you.
    [The prepared statement of Dr. Evans follows:]

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    Mr. Stupak. Thank you, Dr. Evans.
    Ms. Gould, your testimony, please. You are General Counsel 
for 23andMe.
    Ms. Gould. That is correct. Thank you.
    Mr. Stupak. If you want to pull that mike forward, and the 
green light should go on when you press the button.

                   TESTIMONY OF ASHLEY GOULD

    Ms. Gould. Chairman Stupak, Ranking Member Burgess, and 
members of the subcommittee, good morning and thank you for 
inviting 23andMe to testify today.
    My name is Ashley Gould, and I am the General Counsel of 
23andMe, as you just heard. I ask that my full written 
testimony be submitted for the record. Thank you.
    It was really helpful to hear and we embrace the prior 
panel. We were disturbed by the percentage of discordants in 
these reports, and we have proposed standards to NIH and FDA. I 
will be talking more about that today.
    In the last 10 years, the Human Genome Project has 
revolutionized genetics. Direct-to-consumer genetics leverages 
these advances by allowing individuals to access their own 
genetic information. Consumers empowered with this information 
have made lifestyle changes aimed at reducing their risks of 
developing disease and have provided information to their 
physicians to aid in diagnosis and treatment.
    23andMe believes the subcommittee's hearing today presents 
an opportunity for all of us to understand the state of the 
science, how best to protect consumers, and to design a 
sensible regulatory framework for the future. We look forward 
to working with Congress as well as the FDA and NIH on these 
issues.
    We strongly agree with the subcommittee that DTC genetic 
testing must be scientifically valid, accurate, and well-
explained to consumers. We are entirely confident in our own 
reports, which we develop in conjunction with our physician and 
scientific advisers.
    We support the subcommittee and FDA in the effort to create 
an improved regulatory framework for genetic testing. We are 
already working with FDA, NIH and other organizations to 
strengthen regulations for all laboratory testing, including 
genetic testing. Indeed, we first met with FDA in 2007 before 
we ever offered our service to consumers. Thereafter, in 2008, 
we met with FDA Commissioner von Eschenbach and his staff and 
they encouraged us to proceed. We have had ongoing discussions 
with FDA since that time.
    Tomorrow, we will present our regulatory proposal to the 
FDA. Our plan takes into account rapid technological innovation 
and ensures the analytical and clinical validity of all 
laboratory tests. In addition, we think new regulations should 
provide transparency across the industry so consumers know what 
they are getting from the services they choose.
    At the heart of any new regulation should be the 
requirement that DTC genetic companies operate at the highest 
levels of science and ethics. 23andMe grounds its service in 
several core elements: Informed consent and strong privacy 
protection; educating customers about personal considerations 
they should take into account when using our service; educating 
customers in providing full transparency about the science 
behind our service; and recommending that if customers have 
questions about their results, they should coordinate with 
their physicians or a genetic counselor.
    Indeed, we are proud that in 2008 our company's DNA testing 
was selected by Time Magazine as the number one invention of 
the year.
    One of 23andMe's core missions is the development of 
innovative solutions for accelerating genetic research. Our 
database is one of the largest collections of genetic and 
health information in existence and has already led to 
published discoveries. We are currently working with the 
Parkinson's Institute on research aimed at discovering the 
genetic factors underlying Parkinson's disease. We are proud to 
have with us today the head of the Parkinson's Institute, Dr. 
William Langston, one of the leading Parkinson's researchers in 
America.
    We appreciate the concern that people who receive DTC 
genetic information could make harmful decisions without 
consulting a physician or could be lulled into inaction based 
on their results. However, we have seen neither data nor 
scientific literature to support this view. Indeed, the current 
scientific literature, combined with our own experience, shows 
that people do not take rash or unconsidered actions.
    Moreover, 23andMe's service is consistent with the FDA's 
long history of approving at-home over-the-counter laboratory 
tests for HIV, hepatitis and other diseases, in addition to 
permitting consumers direct access to tests for other 
conditions, such as high cholesterol and pregnancy.
    We believe the current regulatory landscape is ready for 
improvements, and we welcome your interest and leadership in 
this area.
    Thank you, and I look forward to your questions.
    [The prepared statement of Ms. Gould follows:]

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    Mr. Stupak. Thank you.
    Dr. Vanier, President and CEO of Navigenics. Would you 
testify, please?

                 TESTIMONY OF DR. VANCE VANIER

    Dr. Vanier. Chairman Stupak, Ranking Member Burgess, 
Chairman Waxman, and members of the subcommittee, thank you for 
inviting me here today to testify regarding the role of 
personal genetics in prevention and wellness.
    I am Dr. Vance Vanier, the CEO of Navigenics, a personal 
genetic testing company in California. I am trained originally 
in emergency medicine and have been extraordinarily privileged 
to have been on the front lines of patient care for over 10 
years now.
    I am currently on the faculty at Stanford Medical Center. I 
received my medical degree from Johns Hopkins. I did my 
residency training at the University of California at San 
Francisco.
    While my medical career has taken me certainly to many 
places, there is one thing that I have seen over and over 
again; it doesn't matter whether you are in the inner cities of 
Baltimore or Oakland. It doesn't matter whether you are in the 
more privileged neighborhoods of San Francisco or Stanford. We 
have an epidemic of preventible chronic disease that crosses 
all walks of life, that crosses all geographies.
    So, every time that I diagnose or treat a heart attack in 
the emergency department, it is a failure of prevention and 
wellness. Every time that I diagnose diabetes in a person due 
to their obesity, it is a failure of prevention and wellness. 
Every time I diagnose a late stage colon cancer case because 
that patient never got around to getting their colonoscopy, it 
is a failure of prevention and wellness.
    Most of us in the room here today know what we are supposed 
to do for our health, but we as a society are challenged by the 
fact that we can't seem to be motivated to engage in healthy 
lifestyles or follow our physician's recommendations, and that 
failure is the cornerstone of why millions of Americans suffer 
from preventible disease today.
    So it is in this context of tremendous unmet need that 
genomics is emerging as a powerful behavioral tool to motivate 
action. There is a body of evidence that shows that when people 
understand their genetic information, they are more motivated 
to act to make positive lifestyle choices.
    There is a body of evidence that shows that this sort of 
testing is safe and does not cause long-term, undue 
psychological harm. And, clearly, there is a high interest in 
the American public for testing like this.
    And so, given the scope of the unmet need, given the 
potential power of this information, and given the fact that 
there is high societal interest, we have an extraordinary 
opportunity in this room today to lay the foundation for 
standards of how we can responsibly deliver this information 
with appropriate safeguards. And I can certainly think of no 
better way to set the stage of this dialogue than with this 
subcommittee and the FDA.
    As you hear my testimony today, there are five main points 
that I would like to reinforce.
    First, not all genetic testing companies are the same. 
There is a huge variance in standards that different companies 
bring to bear.
    Second, since we were founded by Dr. David Agus, an 
oncologist of national repute, and Dr. Dietrich Stephan, who is 
a human geneticist who trained under Francis Collins at the 
NIH, we have sought to have the most stringent qualities of 
science. Indeed, our genetic selection criteria meets or 
exceeds standards put out by the CDC.
    Third is the fact that we are passionately clinically 
focused. We believe that you should only test for clinically 
actionable information. Every one of our customers is supported 
by genetic counselors since our founding. And we primarily work 
through physician groups--national physician groups, as well as 
medical centers such as Duke, Scripps, Cleveland Clinic, Mayo 
Clinic, international affiliates of Johns Hopkins. Indeed, 
virtually all of our tests come from physician groups or 
prevention and wellness programs such as ones you might find in 
the corporate channel.
    Fourth is the extremely high standard of our lab 
operations. We are one of the very few companies in our space 
that own and operate our own lab. We are CLIA-certified, and we 
are the only company in our space to be approved by all 50 
States, including the State of New York, which has some of the 
most stringent regulatory standards of any State in the U.S.
    Finally, fifth, we believe that a customer's genetic 
information should be completely private and secure. We do not 
resell or share this information to any third parties, such as 
pharmaceutical companies.
    So, in summary, we believe that a responsible approach, 
coupled with a thoughtful regulatory framework, can set a 
successful foundation for this transformational innovation that 
is happening in prevention and wellness today. And we certainly 
look forward to discussing it with you at length.
    Thank you.
    [The prepared statement of Dr. Vanier follows:]

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    Mr. Stupak. Thank you, Doctor.
    Next we will hear from Dr. David Becker, chief scientific 
officer with Pathway Genomics Corporation.
    Dr. Becker.

                TESTIMONY OF DAVID BECKER, PH.D.

    Mr. Becker. Mr. Chairman, thank you so much. And thank you 
for the opportunity to testify here today.
    I am the chief scientific officer at Pathway Genomics, a 
San Diego-based genetic testing company. Pathway operates its 
own on-site, CLIA-certified, and California State-licensed 
laboratory. We provide physicians and their patients with 
reports based on advanced genetic testing technology and 
validated genetic information, allowing them to make informed 
health decisions.
    Pathway has validated its laboratory-developed genetic 
tests and established quality assurance protocols according to 
Federal standards and guidelines to ensure the accuracy of the 
data we provide.
    The discovery and analysis of the human genome represent 
the dawn of a new era in health care delivery. With this 
expanded knowledge, individuals can develop personalized 
prevention and therapeutic strategies. At the current rate, we 
can expect significant additional discoveries that will allow 
health care providers to provide their patients with more 
effective personalized care, delivered at lower cost, with 
fewer complications.
    Some have taken the position that our understanding and 
association with health outcomes is not yet strong enough to be 
interpreted and/or integrated into clinical care. We would 
concur that the research has to be analyzed objectively and 
reported responsibly. It is not true that consumers, however, 
are unable to benefit from access to this information.
    Pathway currently offers three health-related reports, as 
well as a genetic ancestry report. These reports provide an 
assessment of genetic risk for as many as 25 different health 
conditions, indicate the presence of genetic markers associated 
with 37 different recessive genetic diseases or conditions, and 
project the likely response to nine different medications.
    In addition to providing understandable genetic reports, 
Pathway offers access to clinical experts to ensure that our 
customers and their physicians understand their test results. 
Pathway's staff physicians and genetic counselors are available 
for guidance and support, both pre- and post-testing. These 
qualified experts review every health report prior to delivery, 
looking for indications that warrant separate communication, 
encouraging the customer to speak with one of our counselors--
genetic counselors, that is--or physicians at no additional 
charge.
    Pathway believes that genetic testing can be offered 
directly to customers in ways that help them improve their 
health without creating unacceptable risks. Nevertheless, we 
voluntarily suspended consumer ordering via the Internet and 
retail as we work with FDA to address their concerns over 
direct-to-consumer genetic testing.
    Pathway is committed to improving the health and wellbeing 
of our customers. We are also committed to ensuring that 
everything we do is based on rigorous scientific standards and 
complies with all applicable laws and regulations.
    Genetic testing holds great promise to help people live 
more healthy and productive lives. Allowing consumers, in 
consultation with health care professionals, to access their 
genetic information empowers healthy and positive choices. We 
are excited about the future of genetic testing and look 
forward to continuing our work with FDA, Congress, and our 
colleagues to ensure the services we offer are of the highest 
quality and value to the American public.
    Let me conclude by thanking the committee for focusing 
attention on both the challenges and opportunities that this 
new industry presents. I look forward to answering your 
questions.
    [The prepared statement of Mr. Becker follows:]

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    Mr. Stupak. Thank you. And thanks for your testimony.
    I will start questions.
    Ms. Gould, Dr. Vanier, and Dr. Becker, to get a sample on 
each of you, you would spit in a little vial and the customer 
would send it back to you, correct? None of you use the cotton 
swab?
    Mr. Becker. That's correct.
    Mr. Stupak. OK.
    Let me put up on the board, then, GAO's report. You know, 
Dr. Evans said that he thought it was entertainment versus 
medicine. You all are telling us that your sampling is 
accurate, that you use markers, you assure quality.
    Then why, on Mr. Kutz--he is the 48-year-old male here. And 
I believe Company No. 1 is 23andMe, Company No. 3 is Pathway, 
Company No. 4 is Navigenics.
    So if you just take prostate cancer, if you're all accurate 
and you're all using markers and you take the same kind of 
saliva as your source, why would we have three different 
results for prostate cancer for Mr. Kutz?
    Or even if you go to high blood pressure, Navigenics didn't 
test it, but we got different results. Go to diabetes, with the 
companies, you got different results if you tested for it.
    So how do you explain that? Same person. You all say you 
have quality assurance. You all make sure the markers, and you 
do all this testing. Why do we have three different results 
with three different companies?
    Ms. Gould, do you want to start with you?
    Ms. Gould. Sure. Thank you.
    So we did ask for the GAO testimony in advance and didn't 
receive it. So it would be difficult to respond with 
specificity to these particular conditions, although we are 
happy to follow up to do that.
    And I want to stress that we feel extremely confident in 
the analytical validity of the tests that we have, and----
    Mr. Stupak. But then why wouldn't you all have the same 
result? If you're all so analytical, you're all so accurate, 
you're all so using the markers----
    Ms. Gould. Right. So, for risk predictions, which is a 
subset of the things that the companies test for, we use a 
predictive model. And the predictive model among the companies 
is different based on the standards within the company, which 
is why we agree standards are necessary across the company.
    So we are relatively conservative in the standards that we 
have. We require for these an initial study that has 700----
    Mr. Stupak. So you're saying you're all using different 
standards?
    Ms. Gould. So, there are different standards for inclusions 
of which SNPs are looked at and what weight is given to them. 
And there are differences among which variants can be tested 
among the technologies that are used by the different 
companies.
    So we agree that it is not acceptable to get the different 
results and that we need standards. We have written a letter to 
the head of NIH and FDA requesting their help. We have worked 
with our colleagues and will continue to do that to set these 
standards.
    Mr. Stupak. OK. So what you are saying, then, is you don't 
have standards yet to accurately inform a customer whether or 
not they have prostate cancer, high blood pressure, or 
diabetes. There's no standards yet, so we don't know.
    Ms. Gould. So, 23andMe has standards, and the other 
companies have different standards. There's not a----
    Mr. Stupak. So as long as you all have different standards, 
the customer can't rely--he could get different results from 
every company, then. So there is no reliability then, accuracy.
    Ms. Gould. We believe there is accuracy. We agree there 
need to be uniform standards. I think it's important----
    Mr. Stupak. So the accuracy really depends on whose 
standards you're talking about.
    Ms. Gould. I don't think the accuracy depends on the 
standards. I think it is important to note these are risk 
predictions; these are not diagnoses.
    Mr. Stupak. OK. Well, even call it risk predictions, call 
it whatever you want to call it. We get three different results 
from the same saliva, from the same person, and you all claim 
you got accurate results. How are we to believe any of you can 
accurately do it?
    And Dr. Evans is right, it is entertainment, not medicine.
    Ms. Gould. Again, I agree that we need uniform standards, 
and we are interested in working on that. We agree this is a--
--
    Mr. Stupak. So consumers should not trust any of these 
results until we have uniform standards put forth by NIH and 
the FDA.
    Ms. Gould. We provide a lot of context on our Web site. We 
are fully transparent about exactly what we are looking at in 
these. We do believe that our customers understand what they 
are getting when they see our reports.
    Mr. Stupak. Sure.
    Ms. Gould. We also discuss the interplay between genes and 
environment, that this is a risk prediction. And we do believe 
that customers can rely on the data.
    Mr. Stupak. For entertainment purposes only, not for 
medical reasons.
    Ms. Gould. Our service is for information and educational 
use. We continually remind customers that, if they have 
questions about these health reports, they should seek their 
health care professional or a genetic counselor. And we make 
genetic counseling available through an independent third 
party.
    Mr. Stupak. But Dr. Shuren and Dr. Evans testified that 
even the results we've seen tells a person nothing.
    Ms. Gould. Excuse me?
    Mr. Stupak. That the results medically are useless to them. 
Dr. Shuren testified to that, and Dr. Evans testified to that, 
too.
    Ms. Gould. Well, Francis Collins, in his book, ``The 
Language of Life,'' when he was discussing his Type 2 diabetes 
results, he found that information compelling. And based on 
that information, he lost, I think, 20 pounds.
    So we have other examples in our written testimony----
    Mr. Stupak. Well, I'm not a doctor, but I know if I'm 
overweight I have a chance of diabetes going up. I mean, I know 
that. I could even write a book about it and say that, you 
know?
    Ms. Gould. Right. It gave him the impetus to do something 
about it, which is exactly what Dr. Vanier was talking about.
    So, we also have another example in our written testimony. 
We do believe and have stories of customers who have received 
information, taken it to their physicians, and had improved 
health outcomes. And----
    Mr. Stupak. I guess--if we can put that chart back up. I 
wouldn't believe anything until all those results were the 
same. If we got three good companies, all doing this testing, 
the same type of saliva, from the same person, your results 
should be the same. Until you can do that--and you're right, we 
need standards. And, hopefully, from this hearing, we will move 
along with that.
    And my time is up, so let me go to Mr. Burgess for 
questions.
    Mr. Burgess. Thank you, Mr. Chairman.
    And, actually, as a full-service member of this committee, 
I'm going to answer your question that you asked of the panel. 
And, actually, I'm not going to answer it; Dr. Collins is.
    And you referenced, Ms. Gould, his book, ``The Language of 
Life.'' And he describes the discrepancy that has been put to 
us on the prostate cancer. He said, when he got his results--
his father had actually had the disease. 23andMe results 
arrived. ``I was relieved to see a prediction of lower-than-
average risk. But deCODE disagreed, saying my risk was slightly 
elevated. Navigenics upped the ante substantially, placing me 
at 40 percent higher than the average male.''
    His question, ``What on earth is going here? To sort this 
out, I had to drill down into the details of the lab studies.'' 
And here is the explanation. 23andMe tested for five variants 
known to confer prostate cancer; deCODE tested for 13; 
Navigenics had tested for nine. There was considerable overlap 
between the DNA markers tested, but no company had actually 
tested for the complete set of 16.
    So I guess my question, then, to our three panelists--and 
at least two of the three of you, I heard, use CLIA-certified 
labs to get your results, and that is good. So the results of 
each of those SNPs was accurate. But it is an evolving science 
as to which ones you include in the panel and how you make 
predictions based upon that.
    How do you handle new information as it comes forward? Once 
you decide, Ms. Gould, on that five that you're going to use 
for prostate cancer risk, does that never change? Or, as new 
information comes forward, you've still got the DNA in the 
database, so you could go back and look at any of the other 16 
and make a determination if you decide that a different set 
needs to be used.
    And if there were scientific consensus--and here is where 
the FDA could help--if there was standardization, then perhaps 
there wouldn't be this discrepancy we see on the slide.
    So, my time is limited, but would each of you briefly 
comment on that?
    Ms. Gould. Yes. So we do regularly update our reports, at 
no charge to our customers. And we include new studies as they 
meet our inclusion criteria set forth in our white papers, 
which are on our Web site. So the answer is, yes, we absolutely 
update.
    Dr. Vanier. We do the same.
    I would also mention, as to standards, first of all, I 
think that Dr. Shuren's articulation of a way going forward for 
standards is going to be an excellent one for our industry. In 
the interim, however, I would point out that there are branches 
of government that has put forth standards, such as the CDC 
with their Venice criteria. And that is specifically a set of 
criteria that we have used.
    But, indeed, it is an evolving science. And as new 
standards meet that criteria, they are added to our panels.
    Mr. Becker. We also have a trained staff of geneticists, of 
physicians, and Ph.D. Scientists that review and help to update 
our service on a regular basis.
    Mr. Burgess. Dr. Vanier, one of the clips that they played 
for us was a woman who was given advice that you probably, 
pretty certainly, might definitely have an increased risk. I 
mean, that was a terrible clip. And, again, as I said, that 
sounded like a telemarketer giving genetic counseling.
    Have you done anything to tighten up those standards within 
your company? Because, of all the things we heard this morning, 
that was probably the most startling.
    Dr. Vanier. So, there are two clips. And so, first of all--
actually, let me begin by saying that, regardless of which 
company are the sources for any of those audio clips, it is 
obviously extraordinarily disappointing, both as a physician 
and as a company that is helping lead this industry.
    And until the GAO can tell us which clips belong to which 
company--that would certainly be helpful. I suspect the clip of 
the woman asking for her fiance as a gift, because it 
references ancestry, is not our company because we do not do 
that sort of testing.
    Mr. Burgess. Right. I think your company was identified as 
the one that gave the breast cancer advice.
    And all I would ask is that you've got to tighten that up. 
I mean, regardless of what we do, regardless of what 
legislation, regardless of what regulations the FDA puts out, 
that is unacceptable and truly frightening, that someone with 
no medical background, with just having been given some talking 
points on how to respond to a question, would be answering a 
question of that importance.
    I mean, that is a 30-minute discussion between a patient or 
a primary care doctor. I mean, I know that, because I have had 
those discussions. That is not something you can answer over 
the telephone. And that conversation in no way provided that 
patient any real insight and, in fact, probably provided a 
great deal of worry.
    Dr. Evans, let me just ask you a couple of things. Now, you 
talked about the entertainment value of medicine. We shouldn't 
discount that. I'm an OB/GYN doctor by profession. And, 
certainly, the boutique sonogram, Baby's First Picture, that 
was available in lots of malls during the years that I was 
practicing, I would all the time be asked to comment on the 
pictures that were made on some substandard machine at a 
shopping mall.
    So it is probably no surprise that there is an 
entertainment value for this----
    Mr. Waxman. Mr. Chairman? We have votes on the floor. If 
there is a chance for some of us to ask questions--the 
gentleman's time has expired. He is still in the middle of his 
question.
    I wonder if you would allow me to have a couple of minutes, 
because I'm not going to be able to return to be able to ask 
questions of this panel. His time has expired.
    Mr. Burgess. Very well.
    Mr. Stupak. All right. We'll go a second round.
    Chairman Waxman, for questions.
    Mr. Waxman. Thank you. That will give him a chance to go 
further. And I want to get a chance to ask some questions.
    If we are going to have these consumer tests, there ought 
to be some standards. Ms. Gould, you said there ought to be 
some standards.
    Dr. Vanier, Dr. Becker, do you agree there ought to be some 
standards?
    Dr. Vanier. Clearly, Chairman Waxman.
    Mr. Waxman. OK. So we heard from the first panel that the 
FDA ought to regulate this, because they handle medical 
devices. Do the three of you think that you ought to be 
regulated as medical devices?
    Ms. Gould?
    Ms. Gould. We have not agreed in the past with FDA's 
characterization of our service as a medical device. We are 
meeting with them tomorrow and look forward to hearing more 
about why they believe that. That----
    Mr. Waxman. Well, who should set the standards if it's not 
FDA?
    Ms. Gould. That said, I think FDA should be involved in the 
standards. I was pleased to note Dr. Shuren talking about a new 
framework for genetic testing, and we think that that is really 
needed.
    NIH has also put out comments for a registry. We have 
provided comments for that. We think that is a great thing, as 
well.
    Mr. Waxman. Uh-huh.
    Dr. Vanier, a quick answer to that? Do you think you ought 
to be a medical device regulated by the FDA?
    Dr. Vanier. I would agree, the insight that I have into 
this, as I was invited to speak at the FDA's panel regarding 
all laboratory-developed tests early this week, and I think the 
consensus you heard from the hundreds of companies that 
attended was the FDA clearly has a role to regulate the quality 
of the science and the quality of the markers that were used on 
our panel.
    Mr. Waxman. And, Dr. Becker, do you agree with that?
    Mr. Becker. I do agree with my colleagues. And I think 
Pathway is committed to working with FDA to help develop 
appropriate standards that are prudent in this area but do not 
completely stifle innovation, as well as affect overall 
laboratory-developed tests.
    Mr. Waxman. How would it stifle innovation? If you have to 
live up to certain standards and if you're going to give people 
predictions about their health, upon which they are going to 
act, how would that stifle innovation, to ask----
    Mr. Becker. I don't believe that that will stifle 
innovation. But the current structure of FDA regulation, if 
applied the way it is today, could completely not only--if it 
is applied to all laboratory-developed tests, could 
significantly affect the testing industry, not just genetic 
testing.
    Mr. Waxman. Dr. Evans, you're a physician. If a patient 
came to you with the result of one of these tests that said 
they had a 13 percent risk or a 20 percent risk or a greater 
risk, something like that, either quantified or not, of breast 
cancer, how would you respond to that patient who is alarmed 
and wants to know what it means?
    Dr. Evans. Right. I would tell them several things. First 
of all, I would tell them that, as evidenced by that elegant 
experiment that the GAO did, we have no idea, and neither does 
anybody in those companies, really how to interpret and analyze 
those risks. We simply don't know. And that is obviously quite 
clear.
    Secondly, I would tell them that the magnitude of the 
increased or decreased risk really doesn't matter for them. All 
right? What they need to do, as Representative Stupak said, for 
general health promotion is to do the things we have already 
known for a long time are important in health promotion.
    Thirdly, I would tell you that, when it comes to parsing 
risks, even if we could do that--there are many claims made 
about prevention and the power of prevention. But, number one, 
there isn't a bit of evidence that genetic data is magical in 
its ability to get people to change their behavior.
    And, number two, even if it were--so let me grant for a 
second this fantasy that genetic information is going to induce 
people to change their behavior. If that is the case, we have a 
bigger problem. Because, for every person I identify who is at 
increased risk for a given malady, I will mathematically 
certainly identify another individual who is at a decreased 
risk. If this information is so powerful in changing behavior, 
then I have set the stage for counterproductive behavior in 
those people.
    Mr. Waxman. Now, what would be more valuable to you as a 
physician and your patient, family history or this assessment 
that----
    Dr. Evans. Oh, we actually have tremendous data on that. 
One can take all of the risk factors that we know about for 
diabetes, heart disease, breast cancer, what have you, they add 
nothing to our ability to predict risk if one simply puts a 
patient on a scale, asks them a few questions about their 
family history.
    Maybe someday we will get to the point where we can do 
that, but we are nowhere near that point now. And there is tons 
of data to support my statement.
    Mr. Waxman. Mr. Chairman, if the companies are selling a 
product that promises to improve health, then its scientific 
validity should be established. I don't think we ought to leave 
it to them to decide that question, because they have a 
financial interest to decide it in their way.
    Government has to have some standards and enforce them. We 
do this all the time. FDA seems the appropriate place. The 
question is whether it should be the rigid formulation of a 
medical device or something else. But we need standards, and we 
need them enforced.
    Thank you.
    Mr. Stupak. Thank you, Mr. Chairman.
    We have two votes on the floor. We are going to stand in 
recess for 20 minutes. We will come back with this panel in 20 
minutes.
    We are in recess.
    [Recess.]
    Mr. Stupak. The hearing will come back to order.
    I'd remind the witnesses that they're under oath.
    When we left off, I think Chairman Waxman had finished. So 
it would be to Mr. Gingrey for questions, please.
    Mr. Gingrey. Mr. Chairman, thank you.
    I'm going to start by asking a few questions of Dr. Evans.
    Dr. Evans, in your testimony, you state how important it is 
that the information patients receive be of high quality. From 
what you have seen and heard today from the previous panel and 
from your co-witnesses on this panel, do you have confidence 
that patients are, indeed, receiving high-quality information 
from these companies?
    Dr. Evans. I think there's two parts to that answer.
    With regard to what physicians call analytic validity--that 
is, if they tell you that you have an A, one of the DNA 
building blocks, at disposition, I believe it. OK? Absolutely, 
they do quality work from an analytic standpoint.
    However, with regard to quality related to what we call 
clinical validity--that is, what does this tell you about your 
risk of this disease--I would say, absolutely not. And the GAO 
experiment shows that in a beautiful way. No one knows how to 
interpret these data. And that is quite clear.
    So, quality information, to be of quality, must be 
meaningful. It is not meaningful. And, therefore, I would say, 
no, this isn't quality information.
    Mr. Gingrey. So, measuring one's blood pressure and finding 
that it is elevated, or measuring one's cholesterol and finding 
that it is elevated, or measuring one's blood sugar and finding 
that it is elevated, these are not comparable, then, to this 
information that you would get in regard to this genetic 
testing?
    Dr. Evans. That is absolutely correct. Because there are 
two reasons. One is that I can go to three different doctors, 
and if these doctors are doing their job right, my blood 
pressure is going to be reflected the same at each place. My 
cholesterol should be essentially the same, you know, give or 
take some degree of variation.
    But as we have seen here----
    Mr. Gingrey. Yes, from the slide that Chairman Stupak 
presented in the first panel----
    Dr. Evans. Yes, so this is not comparable information.
    Mr. Gingrey. Well, you know, it reminds me of--and thank 
you for that response. There are scans that companies do to 
detect the amount of calcium in one's blood vessels, whether it 
is the aorta or the coronary arteries, whatever. I mean, you 
just get a report back. And if it is a lot, I guess you'd say 
it is 3-plus.
    And I have a brother who's a year and a half older than me. 
He doesn't like to admit that. But he had one of these tests 
done, and it said, oh, yes, you've got a lot of calcium, and 
you'd better go see your cardiologist. Well, it took him 2 
months to get an appointment. It is a wonder he didn't have a 
heart attack in that time from anxiety.
    But he ended up seeing--but, finally, he ended up on the 
operating table for a coronary angiogram, which showed that, 
you know, he didn't have as much as 60 percent blockage in any 
vessel. And it was just a curiosity, really. And he ended up 
probably spending about $10,000 in the process. And, of course, 
the coronary angiogram is not without risk. He could've had a 
heart attack on the table.
    Dr. Evans. That's right.
    Mr. Gingrey. So, I mean, this is the kind of thing that, as 
a former physician--well, I'm still a physician. I've got an 
active license, thank goodness. But I am concerned, I am 
concerned about this.
    Dr. Evans. Well, yes, Dr. Gingrey, your comparison is 
absolutely apt. The advent of this type of testing is, I think, 
entirely comparable to these scans which we simply don't know 
how to interpret and which, when misinterpreted and not 
understood in context, can lead to harm.
    Mr. Gingrey. Well, you even, in your testimony, Dr. Evans, 
suggested that it is kind of an entertainment thing. It is sort 
of like Dr. Burgess, earlier in his questioning, was talking 
about these ultrasounds that are done in the shopping malls, 
and they're--I don't know--they're more than 3-D, they're 4-D. 
And they're for entertainment purposes.
    Dr. Evans. Sure.
    Mr. Gingrey. I want to switch quickly in my remaining time, 
Mr. Chairman, to ask maybe the triumvirate of Ms. Gould and Dr. 
Vanier and Dr. Becker, do you agree that what you are providing 
to these patients, if you will, or direct-to-the-consumer 
information about their genome is more for entertainment than 
it is for a real therapeutic, possibly, and diagnostic value?
    Dr. Vanier. Dr. Gingrey, I would like to respond to that.
    First, I appreciate and think it is very important that Dr. 
Evans is on this panel. But I want to make it clear that there 
is no uniformity in the academic medical world around issues 
like this. There is indeed, for instance, research that shows 
that behavior does change.
    Second, I think your analogies to high cholesterol and 
hypertension are apt, because the genetic risk information that 
is imparted is relatively of the same predictive value of 
hypertension and high cholesterol. And just as we know many 
people who may drop dead at the age of 90 despite having high 
blood pressure and we know people that, you know, have many 
risk factors and continue to live on and on, these are 
probabilistic; they are not predeterministic. And so the 
information that genetics is uncovering is analogous to the 
risk factors that you used in your practice and I use in my 
practice today.
    There are often analogies made to the body scan industry, 
for instance. And we don't believe they're apt, as long as you 
have a health care professional to support and interpret the 
information. Most of the body scan industry came out of the 
fact that you had vulnerable consumers that were getting these 
CAT scans and then the information was handed over to the 
physicians and they didn't know what to do with them.
    There is clearly an educational gap in the physician base. 
More physicians need to be educated about genetics. But the 
ones that are--for instance, we work with a couple hundred 
physicians--very much know what to do with the information 
because it is akin to the risk information they've been using 
for all of their practice.
    Mr. Gingrey. Dr. Vanier, I'm going to have to let your 
response be suffice for the other two, because I am 2 minutes 
over, or a minute and a half.
    And I will yield back.
    Mr. Stupak. Thank you, Mr. Gingrey.
    I know there's more questions. I know Mr. Burgess has some. 
Let's go another round here.
    Dr. Evans, could you grab that book right there? I've got a 
couple of questions I want to ask you.
    Could someone hand it to him? Thank you.
    You know, we've talked a lot about direct-to-consumer 
testing companies that offer a variety of products for their 
clients. One type of test looks at how a person reacts to and 
breaks down certain prescription medications. This obviously 
can be very useful when a person is diagnosed with an illness 
and the physician is developing a treatment plan.
    But I want to ask you to take a look at Exhibit No. 6 
there. When it is done with direct-to-consumer testing, in that 
world, it really raises some questions. Because if you look at 
Exhibit No. 6, this is an internal Navigenics document that 
shows a consumer's test result for the processing of a drug. I 
need your help there.
    Dr. Evans. Irinotecan.
    Mr. Stupak. OK. Irinotecan. That drug is commonly used for 
treating colorectal and other cancers.
    The document shows us that this consumer has a low risk of 
the side effects for this drug. The document then goes on to 
say that, if he or she is being treated for cancer, then their 
medical team may want to prescribe irinotecan.
    Dr. Evans, in your opinion as a physician, do you think 
this document provides medical advice?
    Dr. Evans. Well, clearly. Yes, it is providing advice, in 
my opinion.
    Mr. Stupak. Good.
    Dr. Vanier, this is your company, right?
    Dr. Vanier. Correct.
    Mr. Stupak. So are you giving medical advice for this 
patient here?
    Dr. Vanier. In fact, the statement you read suggests that 
the patient should do anything in consultation with their 
physician. In no case do we recommend that anyone take 
independent action. This is specifically why we have genetic 
counseling support and why we primarily work through 
physicians.
    Mr. Stupak. Right, but isn't your document--if you take a 
look at it, if you want to see it, it says your patient's risk 
of side effects--you have a high risk here, it says. I want to 
make sure I'm on the right one here, No. 6. OK, this is the 
drug. Your side effect is low risk.
    And so, are you not giving medical advice? I mean, where 
does it say there, ``Consult your physician''?
    Dr. Vanier. The statement, Chairman Stupak, if I understand 
what you are reading, is, ``Based on your genetic markers, 
you're likely to have low risk of side effects.''
    Mr. Stupak. Right. So, based upon--OK. Go ahead.
    Dr. Vanier. Those sorts of statements are pulled directly 
from the pharmacogenomic literature. And, in fact, the 
pharmacogenomic markers on our panel, in many or most cases, 
come from the FDA list of qualified markers.
    Mr. Stupak. Sure. And then it says right underneath that 
where you read, it says, ``We determine your risk by analyzing 
your genetic code.'' So, by looking at the little vial of spit 
that they gave you, you made the determination that this 
individual should take this drug for cancer, right? It would be 
good for them if they had cancer, right? They should take that?
    Dr. Vanier. We specifically point out that it would be 
helpful for the medical team to know that they are at low risk. 
And, in fact, irinotecan testing, along with, for instance, 
Plavix testing, is an area of great interest for oncologists 
and cardiologists today because the data is robust.
    Mr. Stupak. OK, well, let's go to the next one. Let's go to 
Exhibit No. 5 in that book there, OK?
    The document is given to physicians whose patients recently 
had genetic testing done by, again, your company. The document 
notifies the physician that his or her patient is likely to 
have a high risk of side effects of the drug abacavir, a drug 
commonly used for treating HIV infection. The document goes on 
to inform the physician they may want to tailor the patient's 
therapy to reduce the chance of abacavir hypersensitivity and 
lists four treatment options.
    Again, isn't this giving medical advice?
    Dr. Vanier. No. The bright line that is often drawn here is 
we do not specifically state, because the data does not support 
it, which drug the physician should use, which dosing that they 
should consider, et cetera.
    Mr. Stupak. Well, then why do you bring up this drug, then, 
if you're not telling the doctor which drug to use?
    Dr. Vanier. It is information that simply should be taken 
into account. For instance, the FDA has recently put a black 
label warning on Plavix that there are different genetic 
responders. In no case, for instance, for Plavix do we tell the 
physicians what to do. It is simply raising an awareness, just 
the way the FDA did with their labeling.
    Mr. Stupak. And, Dr. Evans, you think they are giving any 
medical treatment here?
    Dr. Evans. Well, it certainly seems to me to be medical 
advice. And I think that this is an example--these two examples 
are very good exemplars of the fact that some of the 
information contained in these scans has robust genetic and 
medical implications. Therefore, this is, you know, I think by 
any commonsense interpretation, medical advice.
    Mr. Stupak. Dr. Vanier, do you certify all these letters 
that go out, as the doctor, then, for Navigenics?
    Dr. Vanier. Yes, we have a medical advisory board that 
looks them over.
    Mr. Stupak. OK. Do you, though? Do you personally?
    Dr. Vanier. Yes.
    Mr. Stupak. OK. So if, as Exhibit No. 5 or No. 6 there, Dr. 
Evans, if I came to you as a patient and gave you this, what 
could you take from this information that I brought to you as I 
received this letter from Navigenics?
    Dr. Evans. Right, I would probably do two things. One is, 
especially in the case of abacavir, the data are so robust that 
show that if one has a particular version of this HLA gene, 
that they are much more likely to have a serious reaction to 
abacavir, I would take that very seriously.
    I would be very tempted to repeat the test because of all 
of the tests that have been done at the same time. But I have 
no great quibble with the analytical validity. I trust that 
result.
    My quibble with that particular issue is that it's medical 
advice.
    Mr. Stupak. My time has expired.
    Mr. Burgess for questions.
    Mr. Burgess. Thank you.
    Dr. Evans, in your written testimony, you--and I think you 
addressed it in response to a question, the issue of being at 
increased and decreased risk, and if someone is at increased 
risk, there's someone out there at decreased risk, and the 
advice might be inappropriate in both instances.
    Now, there was quite a flap created in this committee a 
little less than a year ago, when the United States Preventive 
Health Task Force came with some revised recommendations on 
mammography, that individuals between 40 and 50 no longer need 
them. Well, it turns out they walked back from that.
    And there was also some concern that the health bill, as it 
was being written, would incorporate some of those things, such 
that people covered under specific plans might end up not being 
covered if those guidelines fell outside the U.S. Preventive 
Health Task Force.
    Would it not be worthwhile--if that world was the one that 
had persisted and existed today when the bill was signed into 
law, might this type of testing not be helpful for a woman 
between 40 and 50 to assess whether she go out and purchase on 
her own the screening test that might be life-saving?
    Dr. Evans. Actually, no, for a couple of reasons, 
Congressman.
    Number one, the degree of risk determination that these 
types of tests generally provide is so lacking in robustness 
that we really don't know whether a woman should be getting 
mammograms early or not based on these kinds of results.
    It is very different from the situation for, say, BRCA-1 or 
2, the genes that, as you know, confer an exceedingly high risk 
of breast cancer, in which we've got pretty good data to 
suggest that those women need to be treated very, very 
differently. These results, however, aren't of sufficient 
robustness to really guide who in the population should get 
mammograms early or not.
    And I would also, again, go back to the GAO experiment, 
which shows that we don't know how to interpret them. In other 
words, we will be misassigning women right and left, if we try 
that, that to high-risk or low-risk.
    Mr. Burgess. Well, but the U.S. Preventive Health Task 
Force may have just misassigned everyone in that age bloc.
    Dr. Evans. Yes. Unfortunately, the reality is that, in 
medicine, we--although from a wishful-thinking standpoint we 
might want to be able to assign people a very precise risk, the 
reality is that we are not good at it, as the GAO report shows, 
and that we are asking for trouble, in my opinion, if we start 
telling a woman, ``You don't need mammograms until X date 
because of your genetic profile.''
    Mr. Burgess. Well, but that is not the issue. And I would 
just submit--and I've got some of the same concerns that 
everyone else up here on the dais has. But I would just submit 
that, in a world that at one point seemed to be rapidly moving 
to one-size-fits-all, government-controlled medicine, I would 
think the consumer could see real value in being able to assess 
whether they individually might need to make a different 
decision than their government would make. In which case, this 
type of testing, I think, could be extremely effective.
    Dr. Evans. If this type of testing were consistently--if it 
were consistent between labs, and----
    Mr. Burgess. Right. And we have a Federal agency who is 
responsible for that.
    Dr. Evans [continuing]. And if it were meaningful----
    Mr. Burgess. And my hope is that they will now respond and 
provide the background and the guidance that the consumer 
needs, not so much the provider needs.
    Dr. Evans. Right. The----
    Mr. Burgess. Let me just ask Ms. Gould a question before my 
time runs out.
    Now, you reference in your written testimony an individual 
who had an increased likelihood of a deep-vein thrombosis, a 
blood clot, an increased propensity for blood clots, and wasn't 
aware of this until the testing was done.
    I mean, I will just tell you, as a practicing OB/GYN, 
nothing strikes more fear in your heart that you might do a 
relatively minor procedure on a very young and healthy person 
and have them spend weeks in the hospital recovering from a 
deep-vein thrombosis or, worse yet, die of a pulmonary 
embolism. And that is one of the most frightening things that 
we can face in medicine. You can imagine, from a medical/legal 
standpoint, it is extremely concerning.
    I was intrigued by that story that you included there. We 
went from a world where, early in my career, you just accepted 
that as a risk until, later on, everyone got a low dose of 
heparin right before surgery because we lived in a medical/
legal environment that you just couldn't tolerate the one in 
10,000 who would have that complication.
    So what has the experience been at 23andMe? Are you guys 
following this? I mean, that is a compelling story, but an 
anecdote doesn't a series make. You need at least two anecdotes 
to make a series. Have you been following that?
    Ms. Gould. Yes. And we do have several customer stories. 
And I think this goes to--you know, there was the word used, 
``fantasy,'' before. You know, we strongly disagree with that. 
Colleen McBride at NIH has written that, when people get access 
to their online genetics, it can be very empowering, and it can 
be a great opportunity for a physician to leverage that to help 
them make better lifestyle choices.
    We have had a number of examples where people were getting 
access to this information that they would otherwise really not 
have known, and talked to their physicians and health care 
providers and have seen better health outcomes.
    Mr. Burgess. Well, I will just say, from a clinician's 
standpoint, I mean, you welcome all information that comes from 
any source, especially if it is going to keep you out of that 
kind of trouble.
    Thank you, Mr. Chairman.
    Mr. Stupak. Thank you, Mr. Burgess.
    Ms. DeGette for questions.
    Ms. DeGette. Thank you, Mr. Chairman.
    Thank you for your comments. Mrs. Christensen and I had to 
run over and vote in the Resources Committee.
    I have a couple of follow-up questions that I wanted to 
ask. The first one is on the privacy issues. And, as you know, 
we only have 5 minutes, so if people can be relatively short in 
their answers, I would appreciate it.
    Ms. Gould, does your company believe that we should protect 
the privacy of medical information of the people who undergo 
this testing?
    Ms. Gould. Yes, we absolutely believe----
    Ms. DeGette. Thank you.
    Dr. Vanier. You need to answer verbally.
    Dr. Vanier. Oh. Yes.
    Ms. DeGette. And, Dr. Becker, do you believe that, as well?
    Mr. Becker. We absolutely believe in that.
    Ms. DeGette. OK.
    Now, for Dr. Vanier and Dr. Becker, I realize you did not 
see the GAO report until this morning. But, in the previous 
panel, Mr. Kutz testified that the two companies that told the 
young woman online that her fiance could send in their medical 
information to surprise him with his genetic background were 
your two companies. And I would assume from both of you that 
you have specific policies against this practice.
    Correct, Dr. Vanier?
    Mr. Becker. If you will, Congresswoman----
    Ms. DeGette. Well, I asked Dr. Vanier, and then I will ask 
you.
    Does your company have a specific policy against this 
practice?
    Dr. Vanier. We do. And I would----
    Ms. DeGette. Thank you.
    Dr. Vanier [continuing]. Also like to correct the assertion 
that that was our company, because it was involved in ancestry, 
and we do not offer it.
    Ms. DeGette. OK. Well, no, I wasn't referring to that 
specific audio clip. He said--and, again, this is a little 
unfair to you, I realize, because you haven't seen the GAO 
report. But he said the two companies that told them that they 
could send in the fiance's information were your two companies.
    But if that was the case, that would be against your 
company policies, correct?
    Dr. Vanier. Correct. I would strongly like that information 
corrected.
    Ms. DeGette. Yes, I bet you would, and we'll make sure you 
get it.
    Dr. Becker.
    Mr. Becker. That is correct. That is against our policies. 
We take responsibility for that particular action and feel--
that action was reported. I'm aware of that.
    Ms. DeGette. OK.
    Mr. Becker. That was reported very quickly after that 
discussion with the customer service person happened. We took 
the appropriate----
    Ms. DeGette. So that clip was from your company.
    Mr. Becker. It was.
    Ms. DeGette. And that is against your policy, right?
    Mr. Becker. That is against our policy.
    Ms. DeGette. So this leads to another question, because all 
three of the companies represented here are companies that are 
trying to do important work. And I don't think anybody--well, 
maybe somebody on this panel, certainly not me--would object to 
this type of information being gathered and given to consumers.
    What we are all concerned about is the same thing you're 
concerned about, is that it be done to a high degree of medical 
certainty and that people's privacy is ensured and, also, that 
they get adequate medical advice. I think we can all agree with 
that.
    And so, my question would be, to all three of you, how do 
you think that we could protect confidential patient 
information if you have essentially telemarketing individuals 
on the phones talking to folks about these tests?
    Mr. Becker. If I will----
    Ms. DeGette. Sure.
    Mr. Becker [continuing]. Congresswoman, thank you very much 
for the question.
    We did take action to train that person and correct the 
ability of that to happen. So this was a customer service 
agent. We take it very seriously, this particular incident. And 
we have--we no longer will do that.
    Ms. DeGette. OK. Well, that's good.
    Dr. Vanier, do you have anything to add to that?
    Dr. Vanier. I do. I think we can look at the Genetic 
Information Nondiscrimination Act as a first step of an 
important series of legislation that would include genetic 
protections for consumers.
    Ms. DeGette. But that is already in effect, that act.
    Dr. Vanier. But it speaks to the fact that, obviously, 
individuals--that health plans and companies should not have 
access to that individual genetic data. I think that is a model 
on how you can begin to understand other legislation that would 
protect individuals'----
    Ms. DeGette. So you think we might need additional 
legislation because of the narrowness of that act. Is that what 
you are saying?
    Dr. Vanier. Yes.
    Ms. DeGette. OK.
    Ms. Gould, what would your view be on that?
    Ms. Gould. Well, we have strong both policy and technical 
safeguards to protect customer information. And we agree that 
privacy is of utmost concern. We think GINA is a great start 
and agree that likely more will be needed in the future.
    Ms. DeGette. Thank you.
    Mr. Stupak, I think everyone else has had two rounds but 
Dr. Christensen. So should we have her question and then I'll 
take my second round?
    Mr. Stupak. Sure.
    Ms. DeGette. Thank you.
    Mr. Stupak. Mrs. Christensen for questions.
    Mrs. Christensen. Thank you both.
    My question, I guess, would first go to Dr. Becker. And if 
you could turn to Exhibit 11 in the binder. Mr. Kutz testified 
earlier that none of the companies was able to provide a 
complete genetic analysis for the DNA samples they submitted 
with African American and Asian profiles. And this is 
apparently due to limitations in the ethnic composition of the 
studies that the companies use to predict their customers' 
genetic risk.
    Exhibit 11, at the bottom of the page is an internal e-mail 
dated November 12, 2009, that Pathway produced to the 
committee. And this document, one Pathway employee has sent 
another a proposed script for handling customers who self-
identify as African American or Hispanic and, thus, will 
receive a more limited genetic analysis.
    According to Pathway's document, the company first notifies 
customers of the limited available data when their report is 
almost ready to be sent. And the script for those of African 
descent indicates that they will only be able to provide 
limited information, for example, for females, just three 
conditions--Alzheimer's, Lupus, and Type 2 diabetes--and for 
males, four-- Alzheimer's, lupus, Type 2 diabetes, and prostate 
cancer.
    The script makes clear that the customer had already self-
identified as African American. So why doesn't Pathway tell 
African American customers that the company would not be able 
to provide the full data before they make their payment, you 
know, not just when you're ready to send the results?
    Mr. Becker. Actually, Congresswoman, we do now do that 
activity. As you described, we do inform on our Web site, there 
is a clear matrix of what conditions you will get depending on 
what reported ethnicity you----
    Mrs. Christensen. So you now inform the clients and the 
customers before they make a payment what the limitations are?
    Mr. Becker. Yes, we do. And if they came on to our customer 
site without reviewing that information, it is our policy--and 
clicked on and paid, and then were disappointed with what they 
got, it is our policy to actually refund their money and 
discuss any questions or concerns they may have.
    Mrs. Christensen. OK.
    Well, in the case of the Hispanic--I think it was a 
Hispanic--yes, the self-identified Hispanic customers, the 
proposed letter recommends that, quote, ``we set your ethnicity 
to Caucasian.''
    Are the results accurate if you change someone's ethnicity 
and compare them to data for the wrong population?
    Mr. Becker. The results that we present are based on the 
ethnicities for--and the findings in the literature for those 
ethnicities. So they are accurate for those ethnicities. And we 
are informing Hispanics to look at that information in that 
context, that this is information based on Caucasians.
    Mrs. Christensen. And you feel that it provides accurate 
enough information despite the fact that they're based on 
people of European descent rather than----
    Mr. Becker. Well, that is a very interesting question that 
comes down to the actual population mixture of the Hispanics. 
And the current literature suggests that Hispanics are actually 
divided into groups that are derived from Africans and 
Caucasians.
    Mrs. Christensen. Well, you already don't have much in the 
way of African information.
    But, Ms. Gould, 23andMe produced to the committee an 
internal e-mail, also dated June 23, 2008, concerning a 
complaint of an Asian American customer who was unhappy that 
her genetic report was based on data from a European 
population. It is Exhibit No. 3, I think, in the binder.
    Are the results your company provided to this Asian 
American customer as accurate as they would have been if you 
had data from an Asian population?
    Ms. Gould. So, we provide context in our reports where the 
underlying study--the populations in which the underlying 
studies were conducted. And we make that clear on our Web site, 
as well, that we can only provide data--and we provide this in 
the claim process before people get their data--that genetic 
research is not comprehensive.
    And one of our core missions is actually to undertake more 
research. In fact, one of the projects that we are hoping to 
start is to try to replicate or fail to replicate existing 
studies in African American populations. We do think that it is 
critical that more research be done in order to show the 
applicability of the existing research in various populations. 
Unfortunately, most of this research, which has been NIH-
funded, has primarily been done in European populations. This 
is one of our core missions, is to make----
    Mrs. Christensen. Well, we are very concerned about 
including more racial and ethnic minority populations in 
clinical trials and studies, as well.
    But it seems, unless something has changed since, you know, 
we have this data, you were not, apparently, telling 
individuals that their data would have been limited if they 
were Asian or if----
    Ms. Gould. We do provide that, and we have provided that 
information previously.
    Mrs. Christensen. My time is up. I'll come back.
    Mr. Stupak. Thank you.
    Ms. DeGette, you had some follow-up questions?
    Ms. DeGette. Thank you. I just have a couple follow-up 
questions.
    Dr. Becker, you had testified in your statement that you 
felt that FDA approval of these tests as medical devices could 
stifle innovation. The chairman talked a little bit to Ms. 
Gould about the idea of FDA approval as medical devices. And 
I'm wondering if you can briefly tell me why you think that 
would be the case.
    Mr. Becker. Well, I don't believe that it's FDA approval 
per se. The current structure of requiring premarket approval 
could actually inhibit the ability of this information to be 
accessible to people.
    Ms. DeGette. And why would that be, sir?
    Mr. Becker. Well, because if pre-approval is required for 
all of these tests, it will take quite some time to collect, 
potentially, the clinical validity as defined today.
    Ms. DeGette. So is there some alternate mechanism at the 
FDA that you believe could serve all the purposes we are 
talking about, to give a consistent level of data, to protect 
patient privacy, and also to regulate the kind of information 
they're given? Is there some alternate process at the FDA?
    Mr. Becker. Well, we do, and we do support Dr. Shuren's 
proposal this morning. But we also----
    Ms. DeGette. I'm sorry, which proposal was that?
    Mr. Becker. He proposed a way forward. And I don't remember 
all the details exactly of that.
    Ms. DeGette. OK.
    Mr. Becker. But he proposed a way forward that sounded very 
fair and reasonable, which I think is definitely the FDA's goal 
here. I don't want to speak for FDA, but the--well, I'm sorry. 
I will stop.
    Ms. DeGette. Dr. Vanier, I wonder if you could comment on 
whether you think FDA approval as medical devices is the 
appropriate route to go?
    Dr. Vanier. I think history shows over and over again that 
the correct, deft regulatory touch both protects the public and 
leaves the door open for innovation. Dr. Shuren's proposal, 
that it is the genetic markers that we use in our tests that 
need to be standardized and regulated, is something that we 
would certainly support.
    Ms. DeGette. And that is great, and I support that too. The 
concern that I have, and I think probably many members of this 
committee would share that concern, that is only one component 
of what the problems that we have are. So how would we address 
those other problems in an alternate way?
    Dr. Vanier. I think another component of the regulatory 
process, as has been discussed before, is the actual collection 
kit, the kit in which you, for instance, submit your saliva.
    Ms. DeGette. Right.
    Dr. Vanier. There is a history of that potentially needing 
to be a Class I device. And I think that is also an appropriate 
area to be looked at.
    Ms. DeGette. OK. What about the privacy--well, you already 
talked about that.
    Dr. Evans, I'm wondering if you can comment on all of this.
    Dr. Evans. You bet.
    I think it is absolutely critical to apply a deft hand to 
regulation. Too blunt of regulation could stifle the ability of 
companies and academic laboratories to develop tests. So it is 
important.
    I think the two things that I find most heartening by the 
FDA's approach are to take a risk-calibrated approach to 
testing--that is, you subject tests that have higher stakes to 
more regulation. And secondly, as was pointed out in the first 
panel, that one may be able to envision regulatory schemes 
which look at a subset of markers or a given platform and not 
have to clear every single test, so to speak.
    Ms. DeGette. Mr. Chairman, I want to say two things. I 
think I can probably speak for all of us that we are pleased 
that this panel has recognized that there is a need for 
improvement in standardization in the industry.
    And I would also--it is always the practice of this 
committee to allow panel members to offer questions in writing. 
I think that is particularly important in this case, because 
all of us just received the GAO report this morning. So I would 
ask unanimous consent that we would all have additional days to 
submit questions in writing to this panel, but also that they 
would be able to supplement their answers in today's hearing 
based on the GAO report that they have been given.
    Mr. Stupak. As the gentlelady knows, we always have 10 days 
to put forth additional questions.
    Would you yield on that point?
    Ms. DeGette. Yes, I would be happy to.
    Mr. Stupak. Let me ask our panel this, then, in light of 
what Ms. DeGette said and what we have seen. Our hearing has 
shown that there is a gap between claims made by genetic 
testing companies and the value of the information actually 
given to the consumer. And, as Dr. Evans says, it is more 
entertainment than medicine.
    So let me ask you this, then. Would you agree that until 
the FDA develops standards for testing, uniform standards for 
how you're going to test, uniform standards for genetic 
markers, and ensure the accuracy of the tests and standards for 
interpreting the test results, would you agree to stop this 
direct-to-consumer marketing for monetary value until the FDA 
has this standard set?
    Ms. Gould?
    Ms. Gould. We don't think that that is the answer. We, 
again, believe in the accuracy of our tests. We provide----
    Mr. Stupak. So you're still going to continue marketing 
this test?
    Ms. Gould. We think that it is appropriate that we continue 
and that people have the right to access their genetic 
information.
    Mr. Stupak. For entertainment or for medical reasons?
    Ms. Gould. We provide our information for informational and 
educational use.
    Mr. Stupak. OK.
    Dr. Vanier, would----
    Dr. Vanier. Chairman Stupak, I think it is a great question 
but one put in the context of where we are as an industry. We 
are at the dawn of an era of personalized medicine, as the 
committee has pointed out. And as much early interest as there 
has been in the American public, I think it is important to 
understand that we are all small businesses. I suspect no one 
on this table flew in on a corporate jet this morning, for 
instance. And so, stopping any sort of offering in the public, 
typically from a venture capital perspective, means that most 
of the product category goes away for many years.
    In our case specifically, because we distribute mostly 
through physicians and prevention and wellness programs, we 
would like to continue to be able to do so, given the health 
care support that we give.
    Mr. Stupak. OK. So let me phrase it like this. How much do 
you charge for one of your tests?
    Dr. Vanier. Right now, we are at several hundred dollars.
    Mr. Stupak. OK, several hundred. How many of those several 
hundred is for profit?
    Dr. Vanier. The gross margins range--actually, I would put 
it this way: We are a pre-profitable company. We are still 
venture-capital-funded. We are losing money every year.
    Mr. Stupak. OK. So would you stop marketing for a profit 
then? Would you stop marketing these tests for a profit? I know 
the claim you don't make a profit, but how much money do you 
draw off every year for this testing from Navigenics? Because 
that is part of the company's cost, right?
    Dr. Vanier. Understood.
    Mr. Stupak. So, I mean, if you're doing this for public 
good, why would you charge people then? So we can build these 
databases and do genetic testing. But even if we did that, we 
need uniform standards, don't we?
    Dr. Vanier. I understand. I think most of the innovation in 
health care business shows that you can do well by doing good. 
And I think hopefully that is what we are continuing and would 
like to do.
    Mr. Stupak. We haven't seen any good yet.
    How about you, Dr. Becker? Would you stop marketing it 
until we get some uniform standards in testing here so we can 
interpret these results? I mean, the American people are 
spending a billion dollars a year for nothing.
    Mr. Becker. We think developing standards is absolutely 
critical. And being involved in that process should require the 
members at this table. And in order to do that, we should have 
the ability to have jobs----
    Mr. Stupak. Sure.
    Mr. Becker. --and continue to work hard and help FDA and 
Congress and----
    Mr. Stupak. So would you stop marketing it while we're 
helping FDA and Congress set standards?
    Mr. Becker. We would prefer not to stop marketing as we are 
today. And we are working, similar as Navigenics, with 
physicians and wellness programs. And so we have physicians 
involved, we have genetic counselors involved.
    We feel that it is important to allow the public access to 
this information if they want it and present it in a 
responsible fashion, telling what genetics can and can't do. I 
think it is very important----
    Mr. Stupak. So what do you pay a physician to be involved 
in this? What does your company pay a physician to be involved 
in this?
    Mr. Becker. Yes, we would.
    Mr. Stupak. How much do you pay them?
    Mr. Becker. That is not my area. And I can get back to the 
committee----
    Mr. Stupak. OK, we will follow it up in writing.
    Mr. Burgess?
    Mr. Burgess. Let me ask you a question. Are all three of 
the companies represented here today based in the United 
States?
    Ms. Gould. Yes.
    Dr. Vanier. Yes.
    Mr. Becker. Yes, we are.
    Mr. Burgess. Now, one of the companies that is not here, 
deCODE, is based in Iceland. Are any of you currently marketing 
your products in Europe, for example, in the European Union?
    Ms. Gould. We do offer our services in Europe.
    Dr. Vanier. We are mostly in Asia and Canada.
    Mr. Becker. We currently do not offer our products in 
Europe.
    Mr. Burgess. What is the experience with offering in 
Europe? What is the regulatory environment in Europe as relates 
to these products?
    Ms. Gould. We haven't heard any specific issues around it.
    Mr. Burgess. Europe has a similar regulatory agency to the 
Food and Drug Administration. There are obviously some 
differences. But so far, they have not shown any interest or 
curiosity in what is going on?
    Ms. Gould. Correct.
    Mr. Burgess. And the Canadian equivalent of the FDA, Dr. 
Vanier?
    Dr. Vanier. Currently, no.
    Mr. Burgess. So at this point, the only regulatory efforts 
that you are aware of are coming from the United States?
    Dr. Vanier. No, let me recharacterize my statements. While 
we have little commercial experience, for instance, in Europe, 
clearly genetic testing is an area of regulation in many 
countries. I know England has been taking a look at it, Germany 
has been taking a look at it as well, and there are clearly 
many personalized medicine coalitions and efforts in Canada as 
well.
    Mr. Burgess. And can the experiences of those bodies inform 
the activities that we are going to embark upon at the FDA? Is 
there a possibility for learned--or sharing learned 
experiences?
    Dr. Vanier. I think that is always the case. However, in 
this specific case, I believe the FDA is showing leadership, 
compared to their counterparts abroad.
    Mr. Burgess. Well, let me just say that personalized 
medicine, I do believe that is the wave of the future. In fact, 
that is one of those things that concern me so much about this 
bill that we passed and got signed into law 3 months ago, was 
it moved us away from an environment of personalized medicine 
and moved us more into a regimented command and control type of 
structure.
    So I for one am encouraged by what you are doing. I do want 
it done right. I do want the consumer protected, and I do want 
the information to be believable.
    Yes, the FDA has a role to play, but I would submit that 
each of you and your companies has a role to play as well. And, 
yes, while there are some proprietary and some competitive 
issues to be protected, there is also the greater concept to be 
protected as well, which is allowing consumers to access 
information, just as we would a blood pressure or cholesterol 
or a blood glucose at a health fair that might be at any one of 
our churches or community centers back home.
    So I think, Mr. Chairman, that is probably the extent of 
what I had. I did want to see if we could perhaps recall----
    Mr. Stupak. Yes, Mr. Burgess, we will do that. I owe Mrs. 
Christensen a round of questions, if she would like. We will 
wrap it up with this panel and bring back Mr. Kutz. He is still 
here.
    Mrs. Christensen. Thanks. Let's continue the same line of 
questioning I had before. Do all of the companies represented 
here have disclaimers regarding the limited results that would 
be available for people of different races and ethnicities?
    Dr. Vanier. If I actually may correct an assertion made by 
Dr. Kutz, we do not collect any sort of ethnic information from 
our patients whatsoever, but we do certainly as well help 
educate them about the promises and limitations of the 
information, given the state of the ethnic literature.
    Mrs. Christensen. That is prominently displayed somewhere 
on your Web site?
    Dr. Vanier. Yes.
    Mrs. Christensen. The answer is yes to the other two? So 
what if someone happens to miss that? I am hoping that it is 
really prominently placed on your Web site. Don't you think 
that someone should follow up for those? I guess I would be 
asking Ms. Gould and Dr. Becker since you two do ask that 
question, follow up.
    If a person says they are Hispanic, Asian or African 
American or Native American, do you feel an obligation to go 
back and check and make sure that they understand that the 
information is going to be limited or don't you think there 
should be a checkmark or something to make sure that they see 
that they have seen that and noted that before they send in 
their payment?
    Ms. Gould. I think it is a great idea. It is something that 
I will definitely take back to the team, the concept of sort of 
a checkmark, do you understand this. We do not do follow-ups, 
to say do you understand, in which cases there have been only 
European studies.
    Our service is also broad. We cover ancestry and other 
areas that are not as dependent upon ethnicity. So we feel like 
everybody has something to learn from our service. We do 
highlight the fact that genetic research is not comprehensive, 
and we want to be, again, part of learning more about that.
    Mrs. Christensen. OK. Briefly, if I could get one other 
question in.
    Mr. Becker. Just a quick answer. We could improve our 
service to follow-up. We also do not do that particular type of 
follow-up that you indicate.
    Mrs. Christensen. I was out for a while, so this question 
may have been asked in one way or another, and I am going to 
ask everyone, starting with Dr. Becker.
    We have heard compelling testimony that the science is not 
there yet to meaningfully interpret the data that these kind of 
genetic tests product regarding risk for diseases, not even 
good enough to be interpreted by health professionals. As a 
physician, I feel comfortable though that if I took a good 
history, did a good physical and did some routine lab, I would 
get significant information on which I could predict, and 
useful information on risk for certain diseases.
    Why then should someone order these tests, especially 
somebody from a racial and ethnic minority background? Dr. 
Becker?
    Mr. Becker. Certainly there are limitations in the state of 
science that are even higher relative to the other ethnic 
backgrounds outside of Caucasians, and we support NIH's effort 
to ameliorate that problem.
    We think that being overlooked here is the motivational 
aspect of this particular service and the fact that these 
conditions show some increased propensity for cardiovascular 
disease, clearly Type 2 diabetes, things that are clearly 
actionable and affected by diet and exercise.
    So although we recognize the fact that these conditions are 
not predictive at this time, and that needs to be responsibly 
reported to the public so that they understand clearly, we 
spend a lot of time developing the extensive amount of 
information that is provided to the customer about that 
specific effort.
    Mrs. Christensen. Dr. Vanier?
    Dr. Vanier. There are well-known limitations to the 
physical exam. There are well-known limitations to the tools 
that we use in everyday medicine. For example, the National 
Cancer Institute just looked at the limitations of family 
history for screening for prostate cancer and breast cancer. 
And while indeed you have heard testimony today that the 
science may be early and evolving, you have also heard 
testimony today about the medical importance, for instance, of 
things like pharmaco-genomic testing. And I think when you hear 
the totality of the testimony today, an important point to make 
is none of us should be satisfied with the status quo, none of 
us should be satisfied with the state of the American health 
care system, and it is tests like these that open up a future 
of great use.
    Ms. Gould. I agree with what Dr. Vanier just said. In 
addition, we believe that people have the right to access their 
genetic information if they want to do that, and we think it is 
really important and it is a great educational tool to learn 
about genetics within the prism of your own data. And we think 
that is an important aspect to our service as well, as well as 
getting people in the research we are undertaking to advance 
our understanding of genetics overall.
    Dr. Evans. So, as my testimony has indicated, I think that 
the value of the bulk of this information is extremely low. I 
think that if one can get less meaningful, it is less 
meaningful for those of minorities. I think that I also agree 
that people should have access to their own genomes. But, 
again, I think that the claims made for that information should 
comport with reality, and I think that the idea that this adds 
to motivation or adds to our information is clearly 
demonstrably incorrect at this point.
    Mrs. Christensen. Thank you.
    Mr. Stupak. Thank you, Ms. Christensen.
    Let me thank this panel for their testimony and thank you 
for appearing today to help us understand this problem. We all 
have a lot more work to do in this area. I appreciate your 
being here.
    I excuse this panel. I am going to ask Mr. Kutz to come 
back for a couple of questions, if he would. Thank you.
    Mr. Stupak. Mr. Kutz, a couple of questions, if I may. Can 
we put up the slide of the predictions of the 48-year-old male, 
the one we had up earlier, the first question or two, and then 
Mr. Burgess has some questions on some other parts of your 
testimony and we will get to that.
    There has been some confusion. Identify the companies, 
company one, two, three, four, if you would, please, for us.
    Mr. Kutz. Company number one is 23andMe; two is Decode, the 
one Dr. Burgess said I should look at actually; three is 
Pathway; and four is Navigenics.
    Mr. Stupak. OK. Decode, number two, that was the company 
from Iceland, I believe you said?
    Mr. Kutz. That is correct.
    Mr. Stupak. That is all I had. You wanted to clarify some 
parts, Mr. Burgess, with this witness?
    Mr. Burgess. Yes, sir. We had two vignettes, one that dealt 
with the risk factors for breast cancer and one that asked a 
question about obtaining a surprise for their fiance.
    Mr. Stupak. Can we get those vignettes up?
    Mr. Burgess. There you go. Can we identify the companies so 
we are clear on that, because there was some confusion here on 
the dais here.
    Mr. Kutz. Yes, sir. On the breast cancer it is Navigenics.
    Mr. Stupak. And the other one you wanted was----
    Mr. Burgess. The awesome gift. It would be an awesome gift.
    Mr. Kutz. That is Pathway.
    Mr. Stupak. Again, we just should identify for the record 
it is the individual who wants to give his fiance the DNA 
testing results, and that was Pathway. Do you have any further 
questions of this witness?
    Mr. Burgess. No.
    Mr. Stupak. No further questions. Thank you, and thank you 
for your clarification.
    OK, that concludes all questioning. I want to thank all of 
our witnesses for coming today and for their testimony.
    The committee rules provide for and as we said during the 
hearing, members have 10 days to submit additional questions 
for the record. It has also been requested and is unanimous 
consent that any of our witnesses who testified who wish to 
supplement their testimony will have 10 days to do so.
    That concludes our hearing. This meeting of the 
subcommittee is adjourned.
    [Whereupon, at 1:10 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

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