[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 U.S. GOVERNMENT PRINTING OFFICE 78-125 WASHINGTON : 2013 ----------------------------------------------------------------------- For sale by the Superintendent of Documents, U.S. Government Printing Office, http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center, U.S. Government Printing Office. Phone 202�09512�091800, or 866�09512�091800 (toll-free). E-mail, [email protected]. 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:] [GRAPHIC] [TIFF OMITTED] T8125A.001 [GRAPHIC] [TIFF OMITTED] T8125A.002 [GRAPHIC] [TIFF OMITTED] T8125A.003 [GRAPHIC] [TIFF OMITTED] T8125A.004 [GRAPHIC] [TIFF OMITTED] T8125A.005 [GRAPHIC] [TIFF OMITTED] T8125A.006 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:] [GRAPHIC] [TIFF OMITTED] T8125A.007 [GRAPHIC] [TIFF OMITTED] T8125A.008 [GRAPHIC] [TIFF OMITTED] T8125A.009 [GRAPHIC] [TIFF OMITTED] T8125A.010 [GRAPHIC] [TIFF OMITTED] T8125A.011 [GRAPHIC] [TIFF OMITTED] T8125A.012 [GRAPHIC] [TIFF OMITTED] T8125A.013 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:] [GRAPHIC] [TIFF OMITTED] T8125A.014 [GRAPHIC] [TIFF OMITTED] T8125A.015 [GRAPHIC] [TIFF OMITTED] T8125A.016 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:] [GRAPHIC] [TIFF OMITTED] T8125A.017 [GRAPHIC] [TIFF OMITTED] T8125A.018 [GRAPHIC] [TIFF OMITTED] T8125A.019 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. 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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:] [GRAPHIC] [TIFF OMITTED] T8125A.053 [GRAPHIC] [TIFF OMITTED] T8125A.054 [GRAPHIC] [TIFF OMITTED] T8125A.055 [GRAPHIC] [TIFF OMITTED] T8125A.056 [GRAPHIC] [TIFF OMITTED] T8125A.057 [GRAPHIC] [TIFF OMITTED] T8125A.058 [GRAPHIC] [TIFF OMITTED] T8125A.059 [GRAPHIC] [TIFF OMITTED] T8125A.060 [GRAPHIC] [TIFF OMITTED] T8125A.061 [GRAPHIC] [TIFF OMITTED] T8125A.062 [GRAPHIC] [TIFF OMITTED] T8125A.063 [GRAPHIC] [TIFF OMITTED] T8125A.064 [GRAPHIC] [TIFF OMITTED] T8125A.065 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:] [GRAPHIC] [TIFF OMITTED] T8125A.066 [GRAPHIC] [TIFF OMITTED] T8125A.067 [GRAPHIC] [TIFF OMITTED] T8125A.068 [GRAPHIC] [TIFF OMITTED] T8125A.069 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:] [GRAPHIC] [TIFF OMITTED] T8125A.070 [GRAPHIC] [TIFF OMITTED] T8125A.071 [GRAPHIC] [TIFF OMITTED] T8125A.072 [GRAPHIC] [TIFF OMITTED] T8125A.073 [GRAPHIC] [TIFF OMITTED] T8125A.074 [GRAPHIC] [TIFF OMITTED] T8125A.075 [GRAPHIC] [TIFF OMITTED] T8125A.076 [GRAPHIC] [TIFF OMITTED] T8125A.077 [GRAPHIC] [TIFF OMITTED] T8125A.078 [GRAPHIC] [TIFF OMITTED] T8125A.079 [GRAPHIC] [TIFF OMITTED] T8125A.080 [GRAPHIC] [TIFF OMITTED] T8125A.081 [GRAPHIC] [TIFF OMITTED] T8125A.082 [GRAPHIC] [TIFF OMITTED] T8125A.083 [GRAPHIC] [TIFF OMITTED] T8125A.084 [GRAPHIC] [TIFF OMITTED] T8125A.085 [GRAPHIC] [TIFF OMITTED] T8125A.086 [GRAPHIC] [TIFF OMITTED] T8125A.087 [GRAPHIC] [TIFF OMITTED] T8125A.088 [GRAPHIC] [TIFF OMITTED] T8125A.089 [GRAPHIC] [TIFF OMITTED] T8125A.090 [GRAPHIC] [TIFF OMITTED] T8125A.091 [GRAPHIC] [TIFF OMITTED] T8125A.093 [GRAPHIC] [TIFF OMITTED] T8125A.094 [GRAPHIC] [TIFF OMITTED] T8125A.095 [GRAPHIC] [TIFF OMITTED] T8125A.096 [GRAPHIC] [TIFF OMITTED] T8125A.097 [GRAPHIC] [TIFF OMITTED] T8125A.098 [GRAPHIC] [TIFF OMITTED] T8125A.099 [GRAPHIC] [TIFF OMITTED] T8125A.100 [GRAPHIC] [TIFF OMITTED] T8125A.101 [GRAPHIC] [TIFF OMITTED] T8125A.102 [GRAPHIC] [TIFF OMITTED] T8125A.103 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:] [GRAPHIC] [TIFF OMITTED] T8125A.104 [GRAPHIC] [TIFF OMITTED] T8125A.105 [GRAPHIC] [TIFF OMITTED] T8125A.106 [GRAPHIC] [TIFF OMITTED] T8125A.107 [GRAPHIC] [TIFF OMITTED] T8125A.108 [GRAPHIC] [TIFF OMITTED] T8125A.109 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:] [GRAPHIC] [TIFF OMITTED] T8125A.110 [GRAPHIC] [TIFF OMITTED] T8125A.111 [GRAPHIC] [TIFF OMITTED] T8125A.112 [GRAPHIC] [TIFF OMITTED] T8125A.113 [GRAPHIC] [TIFF OMITTED] T8125A.114 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. 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