[House Hearing, 109 Congress] [From the U.S. Government Publishing Office] HUMAN CLONING AND EMBRYONIC STEM CELL RESEARCH AFTER SEOUL; EXAMINATION EXPLOITATION, FRAUD AND ETHICAL PROBLEMS IN THE RESEARCH ======================================================================= HEARING before the SUBCOMMITTEE ON CRIMINAL JUSTICE, DRUG POLICY, AND HUMAN RESOURCES of the COMMITTEE ON GOVERNMENT REFORM HOUSE OF REPRESENTATIVES ONE HUNDRED NINTH CONGRESS SECOND SESSION __________ MARCH 7, 2006 __________ Serial No. 109-169 __________ Printed for the use of the Committee on Government Reform Available via the World Wide Web: http://www.gpoaccess.gov/congress/ index.html http://www.house.gov/reform U.S. GOVERNMENT PRINTING OFFICE 29-580 PDF WASHINGTON : 2006 ------------------------------------------------------------------ For sale by Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; DC area (202) 512-1800 Fax: (202) 512-2250. Mail: Stop SSOP, Washington, DC 20402-0001 COMMITTEE ON GOVERNMENT REFORM TOM DAVIS, Virginia, Chairman CHRISTOPHER SHAYS, Connecticut HENRY A. WAXMAN, California DAN BURTON, Indiana TOM LANTOS, California ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York JOHN L. MICA, Florida PAUL E. KANJORSKI, Pennsylvania GIL GUTKNECHT, Minnesota CAROLYN B. MALONEY, New York MARK E. SOUDER, Indiana ELIJAH E. CUMMINGS, Maryland STEVEN C. LaTOURETTE, Ohio DENNIS J. KUCINICH, Ohio TODD RUSSELL PLATTS, Pennsylvania DANNY K. DAVIS, Illinois CHRIS CANNON, Utah WM. LACY CLAY, Missouri JOHN J. DUNCAN, Jr., Tennessee DIANE E. WATSON, California CANDICE S. MILLER, Michigan STEPHEN F. LYNCH, Massachusetts MICHAEL R. TURNER, Ohio CHRIS VAN HOLLEN, Maryland DARRELL E. ISSA, California LINDA T. SANCHEZ, California GINNY BROWN-WAITE, Florida C.A. DUTCH RUPPERSBERGER, Maryland JON C. PORTER, Nevada BRIAN HIGGINS, New York KENNY MARCHANT, Texas ELEANOR HOLMES NORTON, District of LYNN A. WESTMORELAND, Georgia Columbia PATRICK T. McHENRY, North Carolina ------ CHARLES W. DENT, Pennsylvania BERNARD SANDERS, Vermont VIRGINIA FOXX, North Carolina (Independent) ------ ------ David Marin, Staff Director Teresa Austin, Chief Clerk Phil Barnett, Minority Chief of Staff/Chief Counsel Subcommittee on Criminal Justice, Drug Policy, and Human Resources MARK E. SOUDER, Indiana, Chairman PATRICK T. McHenry, North Carolina ELIJAH E. CUMMINGS, Maryland DAN BURTON, Indiana BERNARD SANDERS, Vermont JOHN L. MICA, Florida DANNY K. DAVIS, Illinois GIL GUTKNECHT, Minnesota DIANE E. WATSON, California STEVEN C. LaTOURETTE, Ohio LINDA T. SANCHEZ, California CHRIS CANNON, Utah C.A. DUTCH RUPPERSBERGER, Maryland CANDICE S. MILLER, Michigan MAJOR R. OWENS, New York GINNY BROWN-WAITE, Florida ELEANOR HOLMES NORTON, District of VIRGINIA FOXX, North Carolina Columbia Ex Officio TOM DAVIS, Virginia HENRY A. WAXMAN, California Marc Wheat, Staff Director Michelle Gress, Counsel Malia Holst, Clerk Tony Haywood, Minority Counsel C O N T E N T S ---------- Page Hearing held on March 7, 2006.................................... 1 Statement of: Battey, James F., Jr., M.D., Ph.D., Chair, NIH Stem Cell Task Force, Director, National Institute on Deafness and Other Communication Disorders, National Institutes of Health, U.S. Department of Health and Human Services; Bernard Schwetz, D.V.M, Ph.D., Director, Office for Human Research Protections, U.S. Department of Health and Human Services; and Chris B. Pascal, Director, Office of Research Integrity, U.S. Department of Health and Human Services.... 30 Battey, James F., Jr..................................... 30 Pascal, Chris B.......................................... 44 Schwetz, Bernard......................................... 36 Chole, Richard A., M.D., Ph.D., Lindberg professor and chairman, Department of Otolaryngology, Washington University School of Medicine, St. Louis; Judy Norsigian, executive director, Our Bodies Ourselves, co-author of ``Our Bodies, Ourselves''; Joe Brown, Parkinson's Action Network State coordinator, Texas; Diane Beeson, M.A., Ph.D., professor emerita, Department of Sociology and Social Services, California State University, East Bay; Richard Doerflinger, deputy director, secretariat for pro- life activities, U.S. Conference of Catholic Bishops; and Debra J.H. Mathews, M.A., Ph.D., assistant director for science programs, the Phoebe R. Berman Bioethics Institute, Johns Hopkins University................................... 66 Beeson, Diane............................................ 87 Brown, Joe............................................... 83 Chole, Richard A......................................... 66 Doerflinger, Richard..................................... 112 Mathews, Debra J.H....................................... 126 Norsigian, Judy.......................................... 76 Letters, statements, etc., submitted for the record by: Battey, James F., Jr., M.D., Ph.D., Chair, NIH Stem Cell Task Force, Director, National Institute on Deafness and Other Communication Disorders, National Institutes of Health, U.S. Department of Health and Human Services, prepared statement of............................................... 33 Beeson, Diane, M.A., Ph.D., professor emerita, Department of Sociology and Social Services, California State University, East Bay, prepared statement of............................ 89 Brown, Joe, Parkinson's Action Network State coordinator, Texas, prepared statement of............................... 85 Chole, Richard A., M.D., Ph.D., Lindberg professor and chairman, Department of Otolaryngology, Washington University School of Medicine, St. Louis, prepared statement of............................................... 70 Cummings, Hon. Elijah E., a Representative in Congress from the State of Maryland, prepared statement of............... 18 Doerflinger, Richard, deputy director, secretariat for pro- life activities, U.S. Conference of Catholic Bishops, prepared statement of...................................... 115 Mathews, Debra J.H., M.A., Ph.D., assistant director for science programs, the Phoebe R. Berman Bioethics Institute, Johns Hopkins University, prepared statement of............ 128 McHenry, Hon. Patrick T., a Representative in Congress from the State of North Carolina, prepared statement of......... 22 Norsigian, Judy, executive director, Our Bodies Ourselves, co-author of ``Our Bodies, Ourselves'', prepared statement of......................................................... 79 Pascal, Chris B., Director, Office of Research Integrity, U.S. Department of Health and Human Services, prepared statement of............................................... 47 Schwetz, Bernard, D.V.M, Ph.D., Director, Office for Human Research Protections, U.S. Department of Health and Human Services, prepared statement of............................ 39 Souder, Hon. Mark E., a Representative in Congress from the State of Indiana, prepared statement of.................... 4 Waxman, Hon. Henry A., a Representative in Congress from the State of California, prepared statement of................. 25 HUMAN CLONING AND EMBRYONIC STEM CELL RESEARCH AFTER SEOUL; EXAMINATION EXPLOITATION, FRAUD AND ETHICAL PROBLEMS IN THE RESEARCH ---------- TUESDAY, MARCH 7, 2006 House of Representatives, Subcommittee on Criminal Justice, Drug Policy, and Human Resources, Committee on Government Reform, Washington, DC. The subcommittee met, pursuant to notice, at 2:05 p.m., in room 2247, Rayburn House Office Building, Hon. Mark E. Souder (chairman of the subcommittee) presiding. Present: Representatives Souder, McHenry, Foxx, Schmidt, Waxman, Cummings, Watson, Ruppersberger, and Norton. Staff present: Marc Wheat, staff director and chief counsel; Michelle Gress, counsel; Malia Holst, clerk; Sarah Despres, Tony Haywood, and Naomi Seiler, minority counsels; Earley Green, minority chief clerk; and Teresa Coufal, minority assistant clerk. Mr. Souder. The committee will come to order. Good afternoon, and I thank you all for being here. We are here to examine the controversial research areas of human cloning and embryonic stem cell research in light of the massive scientific scandal in Seoul, South Korea. The scandal revealed that cloning research widely acclaimed by proponents of human cloning and embryonic stem cell research was a fraud. The scandal also brought to light the disturbing fact that women were paid large sums of money, and female assistants were coerced to donate, if that is the word, their eggs for stem cell and cloning research in violation of the Helsinki agreement. Embryonic stem cell research and human cloning have been intense political and societal issues for several years now. Embryonic stem cell research requires the destruction of living human embryos to harvest their stem cells, and research cloning involves the deliberate creation of cloned human embryos for sole purpose of destroying them to obtain their stem cells. Proponents of these research areas promise they will result in therapies and cures for a range of maladies and diseases, although there has been little hard, empirical evidence to support these claims. In fact, there are currently ho human clinical trials or therapeutic applications using human embryonic stem cells. And here I will quote British stem cell expert Professor Lord Winston. ``One of the problems is that in order to persuade the public that we must do this work, we often go rather too far in promising what we might achieve. I am not entirely convinced that embryonic stem cells will, in my lifetime, and possibly anybody's lifetime, for that matter, be holding quite the promise that we desperately hope they will.'' In contrast to the lack of any therapeutic applications using embryonic stem cells, adult stem cells have provided therapeutic benefits to human patients for at least 67 diseases and conditions. Nonetheless, even in the absence of therapeutic applications for embryonic stem cells, scientists have been very clear that they seek to use stem cells from cloned human embryos as research tools. Various critics of research cloning and embryonic stem cell research have raised a myriad of objections to the research: The research necessarily requires the destruction of living human embryos, and in the case of cloning, the special creation of embryos to be destroyed for their stem cells. The research necessarily requires a large number of eggs, likely leading to the exploitation of women in order to obtain their eggs for research. Advocates of research cloning/embryonic stem cell research have created unjustified hype of the research that is not supported by current science, but plays on the hopes of suffering patients. These criticisms were borne out through the cloning research conducted by Dr. Hwang, whose two groundbreaking papers were retracted in January by the peer review journal that initially published them. In addition to admitting that he deliberately fabricated data, Hwang has also admitted the had lied about the circumstances under which he obtained eggs for his research, and that in fact he had used eggs from junior scientists in his laboratory, a violation of the Helsinki declaration, as well as from paid donors. Skeptics of cloning and embryonic stem cell research consistently warned that the sheer volume of eggs needed to pursue this line of research would make it untenable, and virtually invite ethical lapses by feeling the temptation to exploit women for their eggs. Hwang's research proves these fears. He initially claimed that he had used only 185 eggs from female donors, which the scientific community agreed was astonishingly low. But investigators now believe that more than 2,200 eggs were obtained from 199 women. Some donors who have since reported they were in desperate need of money when they were offered and paid more than $1,400 for their eggs. And according to the South Korean National Bioethics Committee, the women had not been properly informed about the risks to their health; 15 to 20 percent of those women developed ovarian hyperstimulation syndrome. This scientific scandal is not an isolated incident of fabrication, without real application to U.S. research efforts. Rather, it highlights the serious inherent political problems with research cloning and embryonic stem cell research, including but not limited to exploitation, fraud, and coercion. The incident is a siren warning against proceeding in these research areas without most cautiously examining the societal costs necessarily associated with it. It would be quite disingenuous to say otherwise. Dr. Hwang was not a rogue scientist operating on the fringes of his field with no oversight. He operated in an environment that proponents of cloning and embryonic stem cell research would like to see adopted in the United States. Dr. Hwang enjoyed the full support of his Government, which vigorously promoted his research and funded it with tens of millions of dollars. Dr. Hwang also enjoyed enormous popular support and had agreed to conduct his research under accepted ethical protocols. Dr. Hwang suspended his research until ethics laws were enacted by the South Korean Government to demonstrate his willing compliance with ethical standards. Dr. Hwang's research was conducted with the approval of two separate Institutional Review Boards. Nonetheless, Dr. Hwang's actions represent the fulfillment of every warning dismissed by proponents of research cloning and embryonic stem cell research. Thousands of eggs were obtained through payments and coercion. Many women suffered terrible side effects after they were not properly informed of the risks. Not a single embryonic stem cell line was obtained for the tens of millions of dollars in Government funds that were invested in research. Anxious patients were misled about the research potential. As stem cell researcher Ron McKay said about the hype involved with embryonic stem cell research and distortions that are not aggressively corrected by scientists, ``To start with, people need a fairy tale. Maybe that's unfair, but they need a story line that's relatively simple to understand.'' Our examination today will include an overview of current Federal policies related to these research areas. In particular, we will hear what if any extra protections exist in the United States that would prevent the type of widespread fraud or exploitation apparent in the Hwang research. Also of special interest to the subcommittee are the huge Federal grants that have been awarded to the University of Pittsburgh researcher Gerald Schatten, who was initially a co-author on one of Hwang's fraudulent papers. We will also hear from scientists, ethicists, women's advocates, and a patient advocate discuss these research areas and the known problems associated with them. On our first panel today, we have James Battey, Chair of the National Institutes of Health Stem Cell Task force, and Director of the National Institute on Deafness and Other Communication Disorders; Bernard Schwetz, Director of the Office for Human Research Protections; and Chris Pascal, Director of the Office of Research Integrity. The second panel consists of Dr. Richard Chole, Lindberg professor and chairman, Department of Otolaryngology, Washington University School of Medicine, St. Louis; Judy Norsigian, executive director, Our Bodies Ourselves, co-author of the book, ``Our Bodies, Ourselves''; Ms. Diane Beeson, professor emerita, Department of Sociology and Social Services, California State University, East Bay; Mr. Richard Doerflinger, deputy director of secretariat for pro-life activities of the U.S. Conference of Catholic Bishops; Ms. Debra Mathews, assistant director for Science Programs, the Phoebe R. Berman Bioethics Institute; and Mr. Joe Brown, Parkinson's Action Network State coordinator of Texas. [The prepared statement of Hon. Mark E. Souder follows:] [GRAPHIC] [TIFF OMITTED] 29580.001 [GRAPHIC] [TIFF OMITTED] 29580.002 [GRAPHIC] [TIFF OMITTED] 29580.003 [GRAPHIC] [TIFF OMITTED] 29580.004 [GRAPHIC] [TIFF OMITTED] 29580.005 [GRAPHIC] [TIFF OMITTED] 29580.006 [GRAPHIC] [TIFF OMITTED] 29580.007 [GRAPHIC] [TIFF OMITTED] 29580.008 [GRAPHIC] [TIFF OMITTED] 29580.009 [GRAPHIC] [TIFF OMITTED] 29580.010 [GRAPHIC] [TIFF OMITTED] 29580.011 [GRAPHIC] [TIFF OMITTED] 29580.012 Mr. Souder. I will now yield to the ranking member, Mr. Elijah Cummings, for his opening statement. Mr. Cummings. Thank you very much, Mr. Chairman. Just yesterday a disgraced researcher, Dr. Hwang Woo Suk, admitted to prosecutors in South Korea that he had directed a subordinate at the World Stem Cell Hub to fabricate research results. This was the first admission by Dr. Hwang of his personal involvement in fabricating claims made by his research team in two landmark papers on embryonic stem cell research published in the journal Science. An investigative team at Seoul National University already had determined that Hwang's claims that he had developed 11 patient-specific stem cell lines were in fact false. Dr. Hwang also acknowledged that donated eggs used in the research were coerced from junior members of his research team, and that some donors had been paid large sums of money. Throughout the investigation, however, Dr. Hwang acknowledged no personal involvement in the scientific fraud. The fraud, exploitation, and coercion for which Dr. Hwang has now admitted personal responsibility have earned him a resounding international rebuke, including from Seoul National University where he was employed. We can only hope that Dr. Hwang's humiliation will serve to deter other scientists who might contemplate seeking glory through reporting fraudulent research, exploiting employees, and coercing women to donate their eggs without informed consent. In a sense, this case offers a measure of vindication to the broader scientific community, demonstrating that it is difficult at best to fool one's peers for very long. Ultimately, the very nature of scientific research tends to ensure that the truth about claims of major scientific advances will surface. In this very high profile case, questions have been raised as to whether the claims of Dr. Hwang's teams should have been verified in advance by the publishing journal. In any case, it was mere months before questions about Dr. Hwang's methods and results began to be called into question publicly. In fact, it is almost startling how quickly many of Dr. Hwang's claims have been thoroughly debunked, including yesterday through his own admission of scientific fraud. But the case of Dr. Hwang is no cause for celebration, even if opponents of embryonic stem cell research seem to have difficulty containing their glee. Opponents of the research have been eager to portray the Korean scandal as proof that not only is this field a research uniquely prone to ethical pitfalls, but that the research itself is inherently bogus, offering nothing more than false hope to patients. Mr. Chairman, I join the mainstream of the United States and the international scientific community in drawing a different lesson and conclusion. This research, which will go forward with or without the U.S. funding and oversight, needs the oversight that the broader U.S. oversight would bring. Our own National Institutes of Health is, without question, the entity best equipped to ensure that embryonic stem cell research proceedings with scientific integrity and in a way that ensures that women who donate their eggs are protected from coercion, exploitation, and undisclosed risk of adverse health effects. In the absence of strong Federal leadership, several States, including California and Maryland, have taken steps toward adopting guidelines for conducting embryonic stem cell research. The National Academy of Sciences has adopted guidelines as well. But accountability for U.S. research will come with substantial support for this research, and that support will also help to ensure that important lines of research that offer relatively less profit potential are pursued. In closing, Mr. Chairman, it is important that we recognize that fraud and ethical misconduct are hardly unique to science, and that scientific fraud is not unique to embryonic stem cell research. Our goal therefore should not be to use this controversy as a justification to impede the search for important new knowledge that could yield therapies and cures for many major diseases. Rather, our objective should be to ensure that as research in this important field inevitably proceeds in and beyond the United States, it does so with the benefit of strict Federal guidelines and a rigorous oversight. With that, Mr. Chairman, I thank our witnesses for appearing today, and I yield back. [The prepared statement of Hon. Elijah E. Cummings follows:] [GRAPHIC] [TIFF OMITTED] 29580.013 [GRAPHIC] [TIFF OMITTED] 29580.014 Mr. Souder. I would like to yield to the vice chairman of the committee, Mr. McHenry. Mr. McHenry. Thank you, Mr. Chairman. Thank you so much for holding this hearing today. Recent events in South Korea have brought to light and global attention has been brought to the issue of human cloning and embryonic stem cell research. A number of concerns have been raised surrounding this subject here and abroad, including the ethical dilemma of destroying life; fraudulent scientific procedures, as has been mentioned by Ranking Member Cummings, as well as exploitation of women. All these are very serious subject matters that we must address here today in this hearing. As a part of this discussion, it is important to make the distinction between human embryonic stem cell research and adult stem cell research. Adult stem cells and the research derived from adult stem cells do not destroy human life, and do not take the essence of life from the host being; whereas in embryonic stem cell research, that is the case. Life is taken from that fertilized egg, and that life is destroyed. Embryonic stem cell research is the purposeful creation of human embryos destined to be destroyed for scientific research, in this case, in the name of stem cell research. Adult stem cells have provided therapeutic benefits and cures to 67 diseases and conditions such as diabetes, damaged heart tissue, strokes, cancers, Parkinson's, and spinal cord injuries, among others. We need to focus in the successes of adult stem cell research, an ethical approach that provides cures and therapies, instead of focusing on this all-too-political, it seems, issue of embryonic stem cell research. Beyond the fact that there are currently no clinical trials or therapeutic applications using embryonic stem cells, there are a number of complications due to this approach, such as immune rejections and the inability to obtain pure cultures. The fact that this process is so inefficient means an outrageous number of eggs will be required for this approach. And I would like to hear from our panel today as to their estimates on how many eggs would be required to actually move forward with major cures and major therapies. Some have said that even for a disease that touches 17 million people or 20 million people, you would have to have roughly 850 million eggs harvested, which means if you had 10 women willing to donate their eggs, you would have to have about 85 million women in this country donate their eggs. It is a staggering sum. And this also goes back to the other issue that is of major substance, and that is the exploitation of women, which has been brought to light with the controversy and the fraud perpetrated out of South Korea. I would like to welcome our witnesses today. I thank you for taking the time to be here. And this issue today is not simply about South Korean research fraud. It is about the larger issue of stem cell research and what is an ethical, realistic, and moral approach that moves science forward while keeping to ethics in medicine and science. Thank you all again for being here today. And again, Mr. Chairman, thank you so much for your hosting this meeting today. [The prepared statement of Hon. Patrick T. McHenry follows:] [GRAPHIC] [TIFF OMITTED] 29580.015 Mr. Souder. Thank you. I will now yield to the distinguished ranking member of the full Committee. Would you yield to Ms. Norton? Ms. Norton. I yield to the ranking member. Mr. Waxman. Well, I thank you both very much for this chance to make an opening statement. We are going to hear testimony today about the ethical issues around embryonic stem cell research and therapeutic cloning. In particular, we will focus on the scandal in South Korea regarding fraudulent research and abuses of research subjects. Many opponents of stem cell research would like to use the South Korean experience as a basis for banning embryonic stem cell research. The story of Dr. Hwang's fraudulent research in South Korea is shocking because we rely on scientists to discover the truth, not subvert it. We need to condemn the fraud, figure out what happened, and learn how we can keep it from happening again. And we need to make sure that this research is well-regulated and thoroughly scrutinized. But banning future stem cell research would be a gross overreaction. Unfortunately, though the vast majority of researchers are honest, fraud sometimes occurs in scientific and medical research. In fact, among Members of Congress, while most are honest, there are some who are not. In 1983, a cardiology researcher at Harvard was found to have fabricated much of his data. In 1996, it was revealed that reports of a re-implanted ectopic pregnancy by British physicians were fraudulent. And in 2002, it was discovered that a rising star physicist working on carbon-based semiconductors had fabricated most of the data. The answer to these instances of fraudulent research was not to ban or deny funding for research on heart disease, ectopic pregnancy, and semiconductors. The right answer is to create and uphold high standards of oversight. When doubts emerge, disclosure, investigation, and corrections must happen swiftly and openly. That is the right response whether the fraud involves heart disease or stem cell research. We are also going to hear questions raised today about the potential benefits to be gained from various types of stem cell research. Those who oppose embryonic stem cell research often claim that because we do not yet know what therapies it will yield, we should not allow it to proceed. That is a flawed line of reasoning. If we followed this to its logical conclusion, it would mean that the Federal Government should only fund research into cures and therapies that we already know about. The argument also understates that we do know about embryonic stem cells. Decades of research have established the potential that these cells hold for addressing serious illnesses such as Alzheimer's, Parkinson's, and even cancer. I say potential, not promise, because there are no promises in any form of research. But what scientists have already learned about stem cells indicates great potential, which is an argument for moving ahead. Opponents of embryonic stem cell research claim that there is still much to learn from adult stem cells and therefore we should focus our efforts there. It is true that adult stem cells may hold potential, and I fully support researching the possibilities of adult stem cells. But evidence tells us that the potential of adult stem cells may be limited because they are already more specialized than other types of stem cells. We should indeed move forward with research on adult stem cell lines, but this is no argument against pursuing study of other types of stem cells with even more potential. The third issue we will discuss today is the safety of women who donate oocytes or eggs for stem cell research. Egg donation relates to a specific type of research called somatic cell nucleic transfer [SCNT]. This technique involves removing the nucleus of an unfertilized egg and replacing it with the nucleus of an adult cell. SCNT has two benefits compared to stem cell research on embryos from a fertility clinic. First, the possible outcome of this research is the production of tissues that are genetic match to the patient, reducing the risk of rejection such as that we have often seen with organ recipients. Second, the technique holds great potential for studying genetic and other diseases because scientists could potentially develop cells using nuclei from people who have the disease. This would not generally be possible using embryos donated from fertility clinics because researchers cannot select the genes for such cells. Witnesses today will discuss their concerns about the safety of the women who donate eggs for this research. Some of these concerns are legitimate. The drugs and techniques used are identical to those used by women undergoing fertility treatments, but they are not without risk. And I believe that we need to carefully examine research and monitor safety. I also agree that we need to think carefully about how egg donors for research should be compensated. We must respect the contribution that these women make, and we must ensure that they participate voluntarily. As with any new field of research, the safety and ethics of human participants are paramount. What we must not do, however, is become paralyzed into inaction. Stem cell research, including research using embryonic cells, may help cure diseases that cause untold suffering to millions of Americans and hundreds of millions more around the world. With strict scientific and ethical oversight, embryonic stem cell research, including SCNT, should be supported with Federal funds. Thank you, Mr. Chairman. [the prepared statement of Hon. Henry A. Waxman follows:] [GRAPHIC] [TIFF OMITTED] 29580.016 [GRAPHIC] [TIFF OMITTED] 29580.017 Mr. Souder. Congresswoman Schmidt. Ms. Schmidt. Thank you. Thank you, Chairman Souder, for holding this important hearing on the abuse in human cloning and embryonic stem cell research. As a strong supporter of reasonable science, true women's health, and the culture of life, this topic is very dear to my heart. I commend you, Chairman Souder, for bringing these panels of experts together to shed light on the dangerous practices that some researchers are willing to use to advance their agenda. They, with the help of the media, have unfairly raised the hopes of many Americans, who have been led to falsely believe that embryonic stem cell cures are possible in the near future. While scientists were touting Hwang's research as groundbreaking and necessary for the medical miracles around the corner, Hwang was actually falsifying data and possibly exploiting women for their eggs. How many of these promises were ill-founded? While it now appears that no scientist has effectively created stem cell lines using cloned embryos, adult stem cell treatments march ahead showing great promise for numerous diseases. The facts have shown that cord blood stem cells and adult stem cells are making great advances in curing diseases today, while clinical trials in embryonic stem cells are still years away. In the light of this fraud and abuse, and the fact that embryonic stem cell research is just not producing the results that were promised, I am proud to have co-sponsored H.R. 596, the Stem Cell Therapeutic and Research Act of 2005, or the cord blood bill, and H.R. 1359, the Cloning Prohibition Act. Again, Mr. Chairman, I applaud your leadership on these issues, and I look forward to learning more about them to working with you for a rightful resolution. Mr. Souder. Thank you. Ms. Norton. Ms. Norton. Thank you very much, Mr. Chairman. I want to thank you for focusing the subcommittee on an unusually thorough-going example of the worst kind of scientific fraud because what we have in the Hwang--I hesitate to call it South Korean example because I would hate to think that is characteristic of the science of our friends in South Korea, but it is certainly an example the likes of which I don't think anyone has ever seen before, a massive scientific fraud at every level, fraud that was so good, as it were, if you would forgive the use of the phrase, that even other scientific researchers around the world were fooled by it. It is a kind of case study in what can happen when nobody is watching very closely, and when scientific research at the cutting edge goes totally and absolutely unregulated. It was very troublesome to see and to count the violations and to see that they ranged from what scientists were doing to violations of individual human rights acknowledged to be important and necessary to the world. So I welcome laying this matter out in detail, although I must say I was fascinated with what my good friends on the other side focused on. I mean, you would have thought this was not the Congress of the United States that could do something about the issue that we are describing today. I mean, we are not a television program. Any reasonably literate person or anybody who looks at television has been scandalized by what happened in South Korea. I am pleased we are focusing on this matter not because of any evidence I know of that anything close to it is happening here, but because I have no reason to believe that what happened in South Korea could not or would not happen here, at least to some degree. And I believe it is urgent to move this Congress and this subcommittee from what we cannot do anything about to what we can and must do something about. This is a national issue, my friends. On a national scientific issue of this kind, the burden is on the Federal Government, first and foremost, to offer leadership and guidance. So if you are really concerned about South Korea, this is the time to focus on remedy, if ever there was. This much is clear: We cannot legislate against science any more than we can legislate against the weather. But we can ourselves enact reasonable measures in order to make sure that Congress does not--that science does not march ahead in violation of every ethical measure that both science universally has accepted and that are a matter of documented international human rights. Instead, very frankly, I must say that time after time, I see the Congress trying to stop science. I am embarrassed by the congressional approach to the march of science. It is as if we were still in the 19th century. Science is marching ahead, and it requires deeply analytical, very deep thinking about how to harness science when we know good and well it is marching. And how do we know it is marching ahead? Well, next door you have heard my good colleague from Maryland talk about what is happening in that State. A Republican Governor, Governor Robert Ehrlich, has proposed spending $20 million on stem cell research in the coming year. That is happening all over the United States. The States are joining the advanced countries of the world, marching ahead to make use of embryonic cell research. I can only hope that in the countries of our allies, the national legislatures have been more enlightened than to sit by and describe the problem, while parts of their countries march ahead and do whatever they want to do. We could affect how Maryland, how California, and how every other State in the United States goes about this work because we are the Federal Government. I have every confidence that Mr. Cummings' colleagues in Maryland are going to take up the slack and do the appropriate guidance. I don't think there is a State in the Union that would allow this work to go forward without redoubling their efforts in every way to make sure that what happened in South Korea cannot happen here. So I don't need to add to the disagreement on the ban on embryonic research. You are not going to change peoples' minds on that. You haven't done it in the States, some of which are governed by Republicans. But I want to ask this question: Unbelievably, Mr. Chairman, no bill has passed this Congress outlawing, banning, even human cloning. Can we agree on that? Can we get everybody to raise their hands on that? Isn't there any part of this issue where we would be prepared to meet our obligations, instead of going over and over again the polarizing issue of shall we ban what we can't ban and what our States are telling us we can't ban because we are going ahead and doing it. So I believe that this hearing is important because perhaps it could lead to more than beating our chests against the obvious. There is no disagreement in the United States of America or among anybody in this Congress that what happened in South Korea should not happen here. Hearings are for remedies. I will be interested in whether any of the witnesses today are prepared to help this Congress move forward on urgently needed remedies. And I Tim Howard, Mr. Chairman. Mr. Souder. Ms. Foxx. Ms. Foxx. Thank you, Mr. Chairman. I want to tell you how pleased I am that you are having the hearing today. I might get the reputation around here for being the person who always brings up the issue of language and how important it is to us. But I hear a lot of very inflammatory terms being used about banning future stem cell research, and legislating against science, and that we are not doing the kinds of things that we should be doing. We have not at all banned--talked about banning stem cell research in the Congress. We have encouraged stem cell research, adult stem cell research. I am really curious about the word ``therapeutic cloning'' being used. I don't know how the destruction of human life could ever be called therapeutic. I think that what you are doing here today is calling attention to what I think is a microcosm of the fraud that has been perpetrated in relation to embryonic stem cell research itself. I think focusing on what has happened in Korea and the fraud that happened there can, I think, enlighten people about this issue of embryonic stem cell research and the negative things about that. So I think we can change peoples' minds. I think we can enlighten people. And I think we can do it in a way that is respectful of human life and not destructive of human life. So I applaud you for holding the hearing, and look forward to our shedding some light on this issue that is the truth, rather than letting something like this continue to be a fraud. We have allowed--unfortunately, people in very sad circumstances think that by the use of embryonic stem cell research, we are going to have a cure right around the corner. And we know that it has brought no cures, whereas adult stem cell research has. So thank you for doing this, and thank you for calling attention to the issue. Mr. Souder. Thank you. I ask unanimous consent that all Members have 5 legislative days to submit written statements and questions for the hearing record, and that any answers to written questions provided by the witnesses also be included in the record. Without objection, it is so ordered. I also ask unanimous consent that all exhibits, documents, and other materials referred to by the Members and the witnesses may be included in the hearing record, and that all Members be permitted to revise and extend their remarks. Without objection, it is so ordered. Before swearing in our first panel, I feel compelled to tell all of our witnesses to remember: This is an oversight committee, not a legislative committee. We only have legislative jurisdiction over narcotics. We do oversight and legislation on narcotics. On the Department of Health and Human Services, we do not write the bills. We are here to talk about the past. What the question is in front of us is what happened there and whether in fact they are inherent to the process, or whether in fact controls can be made to regulate this. It is a legitimate debate, but it is not about where we are headed legislatively. First, we are here to analyze the past, analyze what has happened, analyze what the different agencies are doing and what the potentials are, that then Energy & Commerce and the Health Committee and others would look at legislatively. I think there was some confusion on the panel as to the role of our hearing and what our committee does. And I think it is important to clarify that. Now, as you know, it is the practice of this committee to swear in their witnesses. Our first panel is Dr. James Battey, Chair of the NIH Stem Cell Task Force and Director of the National Institute for Deafness and Other Communication Disorders; Mr. Bernard Schwetz, Director of the Office for Human Research Protections; and Chris Pascal, Director of the Office of Research Integrity. Would you each stand and raise your right hand? [Witnesses sworn.] Mr. Souder. Let the record show that each of the witnesses responded in the affirmative. We appreciate that you have joined us, and we will start with Dr. Battey. STATEMENTS OF JAMES F. BATTEY, JR., M.D., Ph.D., CHAIR, NIH STEM CELL TASK FORCE, DIRECTOR, NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS, NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; BERNARD SCHWETZ, D.V.M, Ph.D., DIRECTOR, OFFICE FOR HUMAN RESEARCH PROTECTIONS, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND CHRIS B. PASCAL, DIRECTOR, OFFICE OF RESEARCH INTEGRITY, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES STATEMENT OF JAMES F. BATTEY, JR. Dr. Battey. Good afternoon, Chairman Souder and distinguished members of the subcommittee. I am pleased to be joined here by my two other colleagues from the Department of Health and Human Services. And I appear before you today in my joint roles as a scientist and Chair of the NIH Stem Cell Task Force to discuss the recent events concerning stem cell research fraud that is reported to have occurred in South Korea. As you know, a review and analysis by the Seoul National University Investigation Committee concluded that human embryonic stem cell lines were not derived from embryos created by somatic cell nuclear transfer, as claimed, that fabricated data was used in publications, and that there had been ethical violations in the donation of human oocytes used in these experiments. In 2004, Dr. Woo Suk Hwang and collaborators published an article in the journal Science claiming that they had derived a stable human embryonic stem cell line, which they referred to as NIGHT-1, from an embryo generated by somatic cell nuclear transfer. That is a process, as Mr. Waxman described, where the nucleus is removed from a human oocyte and replaced by the nucleus from a somatic cell. Subsequent investigation by the Seoul National University investigation committee revealed that this claim was not supported by rigorous DNA testing. In addition, the investigation revealed that the photographs allegedly taken of the NT-1 cell line were in fact photographs of an existing stem cell line not derived from an embryo created by SCNT, but instead derived from an embryo produced by in vitro fertilization. In 2005, Dr. Hwang and collaborators published a second article in Science, where they claimed to have made the process or deriving human embryonic stem cell lines from embryos created by SCNT much more effort than was reported in the 2004 publication, where several hundred oocytes were reported to be needed to create a single stem cell line, which we now know was not created in the way they described. In this paper, the authors claimed to have developed an improved protocol for deriving patient-specific embryonic stem cells from embryos created through SCNT. They reported the creation of 11 human embryonic stem cell lines from 185 embryos created by SCNT, many of which involved nuclei from cells derived from individuals with debilitating diseases such as spinal cord injury, juvenile diabetes, or congenital inherited deficiencies of the immune system. Subsequent review by Seoul National University led the investigation committee to conclude that the data presented in this 2005 paper was based on only two human embryonic stem cell lines, neither of which was derived from an embryo created by SCNT. They concluded that no disease-specific human embryonic stem cell lines derived from SCNT embryos are represented in this publication, nor is there any factual basis for believing the Koreans ever successfully created any such lines. While the events in South Korea are deeply troubling to all of us here and everyone in the scientific community, I think it is important to point out that scientific fraud of this type is not common at all, and is certainly not restricted to the area of stem cell research. As one of your colleagues pointed out earlier, John Darcy fabricated data in hundreds of publications in the area of cardiology over a decade ago. That doesn't mean that it was inappropriate to continue doing work in the area of cardiology. The scientific community must remain as vigilant as we can be to ensure that the risk of scientific fraud is minimized. It is also important to note that such fraud is sometimes revealed, often revealed, when other reputable scientists cannot reproduce results that are subsequently revealed to be fabricated, and the great majority of scientists around the world are deeply committed to rigorous standards of proof and verification. The Rosetta Stone of science is reproducibility in another independent laboratory. And this is where scientific fraud is typically uncovered. The scientific enterprise absolutely depends on such standards. And while the stem cell research fraud in South Korea is completely unacceptable, it does not reflect on the potential of human embryonic stem cell research one way or the other. The vast majority of my scientific colleagues are honest and hardworking in pursuing their research, which they deeply hope will ultimately benefit the human condition. I thank you very much for your time, and I will do the very best I can to answer any questions that the subcommittee may have for me. [The prepared statement of Dr. Battey follows:] [GRAPHIC] [TIFF OMITTED] 29580.018 [GRAPHIC] [TIFF OMITTED] 29580.019 [GRAPHIC] [TIFF OMITTED] 29580.020 Mr. Souder. Thank you. Dr. Schwetz. STATEMENT OF BERNARD SCHWETZ Dr. Schwetz. Mr. Chairman and distinguished members of the subcommittee, I am Bernard Schwetz, the Director of the Office for Human Research Protection. Thank you for inviting me here today to discuss the Department of Health and Human Services [HHS], Protection of Human Subjects regulations, particularly as they relate to human cloning and embryonic stem cell research. These HHS regulations are designed to protect the rights and welfare of all who participate in research studies that are conducted or supported by HHS. They are based in large part on the ethical principles for human subjects research identified in the Belmont Report that was written by the congressionally mandated National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1978. The protection of human subjects in research studies is a priority for HHS, and it is the mission of the Office for Human Research Protections [OHRP], to support, strengthen, and provide leadership to the Nation's system for protecting volunteers in research that is conducted or supported by HHS. By signing an assurance of compliance with OHRP, an institution pledges to conduct its HHS-funded or supported research in accordance with these regulations. In addition to assurances of compliance, the HHS regulations also stipulate a number of other requirements for which the institution and its institutional review board [IRB], are responsible. Primary among these is the need to determine if the risks to subjects are reasonable in relation to anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result. Some research studies offer individual studies the prospect of direct benefit, and others do not. When research studies offer no prospect of direct benefit to research subjects, IRBs must consider whether the potential benefits to society justify the risks to the individual subjects. For these studies, including some research involving human embryonic stem cells, the expected benefits would occur often in the future, and would only be of help to others. Informed consent: At the heart of the human subject protection system is the requirement relating to informed consent. The investigator must seek a potential subject's informed consent according to the requirements laid out in the regulations. The investigator's method for obtaining this consent must be approved by the IRB before it can be used. In seeking informed consent, HHS regulations require that investigators do so only under circumstances that provide the prospective subject with sufficient opportunity to consider whether or not to participate, and that minimizes the possibility of coercion or undue influence. As part of the consent process, the prospective research subject must be given sufficient information about a research study to make an informed decision about whether or not to participate in the research. If the study does not offer the subjects the possibility of direct benefit, this must be clearly stated in the informed consent process. For example, if a research study that involves identifiable human cell lines is not intended to offer donors with the prospect of direct benefit, then prospective donor subjects would need to be informed of this unless the requirement for the informed consent has been waived by the IRB. OHRP guidance on research involving stem cells: OHRP has provided guidance to help insure that investigators and IRBs understood how the HHS regulations apply to research involving human embryonic stem cells, germ cells, and the stem cell- derived test articles. A copy of this guidance is included in my written statement for your consideration. In essence, this guidance indicates when such research does and does not generally meet the HHS definition of human subjects research. Under the HHS regulations, ``human subject'' means a living individual about whom an investigator conducting research obtains either data through intervention or interaction with an individual, or identifiable private information. OHRP considers that neither of these definitions is met with research involving embryonic stem cells as long as the investigator has not obtained data about an individual through a research intervention or interaction, and cannot readily ascertain the identity of the individual from whom the human material was obtained. In such cases, the study would not be considered human subject research and the institution's IRB would not be required to review this type of research. However, some research may use established human cell lines where the donor or donors may be readily identified by investigators, or may involve the obtaining of data through research interventions or interactions with individuals. In these cases, the research is considered to have involved human subjects, it would be governed by the HHS regulations, and IRB review and approval would be required for the research to proceed. Finally, I would like to emphasize that the stem cell research conducted at Seoul National University by Dr. Hwang which provided the impetus for this hearing was neither conducted nor supported by HHS. Quite apart from the issues of fraud and abuse, such research could not have been conducted or supported by HHS under Federal law in the United States. Dr. Hwang's research involved attempts to create new human embryonic stem cell lines solely for research purposes through the process of somatic cell nuclear transfer, sometimes called human cloning. HHS is specifically prohibited by law from supporting research in which a human embryo or embryos are destroyed, as well as from supporting the creation of a human embryo or embryos for research purposes. And that law defines ``human embryo'' to specifically include embryos created by cloning. As it was not conducted or supported by HHS, and does not appear to have been conducted at an institution that voluntarily agreed to comply with the HHS regulations for all human subjects research conducted at the institution, Dr. Hwang's research was therefore not subject to any of the regulatory protections that I have discussed throughout this statement. Thank you for your attention, and I would also be happy to answer any of the questions you may have. [The prepared statement of Dr. Schwetz follows:] [GRAPHIC] [TIFF OMITTED] 29580.021 [GRAPHIC] [TIFF OMITTED] 29580.022 [GRAPHIC] [TIFF OMITTED] 29580.023 [GRAPHIC] [TIFF OMITTED] 29580.024 [GRAPHIC] [TIFF OMITTED] 29580.025 Mr. Souder. Thank you. Director Pascal. Did I say that correctly? Or Pascal? Thank you. STATEMENT OF CHRIS B. PASCAL Mr. Pascal. Chairman Souder and distinguished members of the subcommittee, I appreciate the opportunity to talk to you today about research misconduct and the work of the Office of Research Integrity in the Department of Health and Human Services. ORI is charged with overseeing allegations of research misconduct in biomedical and behavioral research supported by the U.S. Public Health Service. ORI has over 10 years of experience in reviewing misconduct allegations and making findings of research misconduct. PHS-supported research institutions and ORI make findings of research misconduct when evidence demonstrates that fabrication, falsification, or plagiarism has occurred in PHS- funded research. ORI has made more than 160 findings of misconduct since 1992, and has reviewed hundreds of additional allegations of misconduct that did not result in misconduct findings. In May 2005, HHS published a new, more comprehensive regulation governing research misconduct investigations entitled, ``Public Health Service Policies on Research Misconduct,'' codified at 42 CFR part 93, which can be found on the ORI Web site. This new regulation replaces the previous regulation from 1989 for dealing and reporting research misconduct. ORI is aware of the controversy regarding Dr. Hwang's human stem cell research project at Seoul National University and the findings of fraud by the Seoul National University investigation committee. However, based on current information available to ORI, ORI has no jurisdiction in this matter since the research was not supported by PHS funds, and ORI does not have jurisdiction over non-PHS-supported research. Had the actions been under the purview of HHS, ORI has a staff of scientists and additional consultants who have developed extensive knowledge and exploits in overseeing and assessing allegations of research misconduct, primarily through evaluating investigations conducted by the PHS-funded research institution. By law, direct investigations are usually initiated by the research institutions that receive allegations of research misconduct. These allegations are generally made by members of the grantee institution who are part of the particular laboratory or department conducting the research. And I might add that ORI considers these individuals to be heroes in coming forward with allegations of research fraud because without them, it would continue and grow. And those individuals take great risk to come forward. One or more members of the team may suspect misconduct and then report it to the grantee institution directly. Sometimes the investigator suspecting fraud will report to ORI, and then ORI will refer the matter to the appropriate grantee institution for review. Grantee institutions are required by the HHS regulations to report allegations to ORI when they reach the formal stage of investigation of the process, and when admissions of misconduct are made by the accused scientist. In conducting the investigation, the institution must promptly secure the research records--without access to the research records and to the original data, it is very difficult to solve these cases--and other relevant documents in order to have a sound basis to identify and evaluate any evidence of research misconduct. When an institution has completed its investigation, it must submit a written report to ORI. ORI will then engage in a thorough oversight review of the report and, depending on the quality and thoroughness of the investigation, may accept the institutions report and find either misconduct or no misconduct based on the institution's findings. If ORI believes further investigation is required, we may request and review the grantee institution's entire investigation record, including the research data, copies of interviews or tapes of interviews, and other relevant documents. When the analysis is completed, ORI may find no misconduct and close the case, or propose findings, PHS findings of research misconduct. ORI findings of no misconduct, as well as open cases that are under review, are considered confidential, both by the ORI regulation and other Federal law, and ORI does not discuss these cases publicly. When HHS makes a finding of misconduct, however, it formally announces the finding, which is then published in the Federal Register, summarized on the ORI Web site and in our newsletter, and the finding is listed in the NIH Guide for Grants and Contracts. In ORI's view, it is important to make these findings public. Otherwise, scientists can move around to other institutions and commit fraud again if it is not public information. HHS takes findings of research misconduct seriously and takes appropriate action. Findings of research misconduct typically result in remedial HHS administrative actions that may include debarment or suspension from PHS-funded research, which means they cannot come back to the Public Health Service and get new funding for a period of time. And in very serious cases, they could be precluded from doing so for life. ORI also strives to correct the research record that may have been corrupted by fraudulent studies. As you heard earlier today, Science withdrew two articles that were published because of the fraud, and we think that is very important to making sure that the scientific record is accurate and honest for other scientists and the public to rely upon. In those research misconduct cases that result in criminal fraud charges, which has happened a couple of times, and civil proceedings of false claims, ORI works collaboratively with the Department of Justice and other Federal law enforcement agencies, including the HHS Office of the Inspector General. Accused scientists who wish to contest findings of research misconduct are offered a due process administrative hearing to defend themselves. In order to promote research integrity and responsible research practices, ORI has an active education program. We collaborate with the scientific community, and we provide resources to institutions to develop their own educational products. ORI believes that its educational programs and collaborations with the research community can help prevent research misconduct. It will not ever eliminate it just because of the nature of the human condition. For example, ORI has a collaboration with the Association of American Medical Colleges to fund scientific and academic societies to hold workshops and conferences on research integrity issues, or develop guidelines or educational programs describing appropriate normative standards for conducting and reporting research. ORI has a collaboration with the Council of Graduate Schools to fund pilot projects at 10 institutions to provide formal training to graduate students in the responsible conduct of research. ORI has published a booklet on responsible conduct of research that has been translated into Chinese and Japanese, as well as in English. Finally, ORI has an active program of evaluation and research studies, partly in collaboration with the National Institutes of Health within HHS, to determine what scientific practices are working well and to learn what practices can be improved. It is important to study the science of science itself in order to improve how you conduct research. Although any individual case of research misconduct can have serious consequences for biomedical research, it is ORI's experience that the great majority of scientists are dedicated to conducting research in a responsible and professional manner, and are committed to producing research results that will benefit all Americans and healthcare consumers around the world. Thank you for the opportunity to discuss ORI's work, and I would be pleased to answer any questions you have. [The prepared statement of Mr. Pascal follows:] [GRAPHIC] [TIFF OMITTED] 29580.026 [GRAPHIC] [TIFF OMITTED] 29580.027 [GRAPHIC] [TIFF OMITTED] 29580.028 Mr. Souder. Let me start with the questioning. And first, if we are going to have any kind of reasonable discussion, let's cut out this cardiologist stuff and so on. There is a major difference between the exceptions in fraud that we see in the scientific community in fields of research where we have had research for decades and decades, and fraud in the sole big case touted in journals and touted by all sorts of researchers in a field that has no history of such research, and the question of whether the fraud involved was endemic to the process. Don't treat us like little children and try to BS us. It is not going to work. Now, one of the things that Mr. Waxman, Mr. Cummings, and I have had a question about baseball and steroids is whether or not you can trust an institution to patrol itself when they have a financial stake in the matter that is being investigated. And Mr. Pascal, you went through this detail, but you said the first, basic, where you get your information whether there is fraud is whether the grantee discovers there is fraud, who clearly has a conflict of interest. Could you elaborate on this and how you would--how we find out, if the institution chooses to cover up? Because South Korea had tougher laws than we have in the United States, and they weren't followed. Mr. Pascal. Well, it is true that an institution can have a natural preference for not finding research misconduct. It can lead to embarrassment, it may lose--loss of funds from NIH or whoever the funding source is, or whatever. But based on ORI's many years of experiences with institutions, we think most of them want to do a good job in finding out what actually happened, and make findings when it is appropriate. In fact, some institutions make findings of research misconduct that ORI does not pursue because we don't think the evidence is substantial enough to support a finding that we could uphold in an administrative hearing. Also, part of this is in the structure of the regulatory process. Our new regulation has followed the policy established by the Office of Science and Technology Policy which was adopted in 2000, which states that research institutions bear primary responsibility for prevention and detection of research misconduct, and for the inquiry and investigation and adjudication of research misconduct alleged to have occurred in association with the institution. There are also a number of checks and balances in the ORI regulation. ORI has oversight review over the institution's findings. The institution sometimes will make minimal findings or weak findings, and ORI will come in and do additional analysis and investigation with its scientists, and we make additional findings. There is a regulatory requirement that the institution must utilize experts in the relative scientific field, and must ensure objectivity in the investigation. That is a regulatory-- -- Mr. Souder. Let me ask a followup question and we will submit your full answer for the record. Mr. Pascal. OK. Mr. Souder. Because that is basically the procedure that Korea had. In ORI, you have given a major grant to University of Pittsburgh researcher Gerald Schatten, who is the co-author of these studies, who withdrew after the fraud became public, but who was co-author. And I am going to have some detailed questions that we submitted before and we are trying to get the answers to. But given that he cited this Korean research multiple times in his grant application, are you in the process of reviewing that grant? And do you have a process--because in effect, what you were just giving me is a whole process that, if the review was weak, if you had questions about it, then you could step in. Are you reviewing this grant? Mr. Pascal. Due to ORI confidentiality constraints, we cannot admit nor deny any specific---- Mr. Souder. OK. Let me re-ask. Do you have the authority to review this grant based on the information that came out that he had been a co-author of the fraudulent study in Korea? Mr. Pascal. If there is a matter that involves PHS funds and alleged research misconduct, yes. ORI would have authority to review the results of the investigation by the institution. Mr. Souder. And Dr. Battey, I am going to read a number of questions here. You have been--we sent these over 2 years ago. Your response to some of the questions was--not these particular questions, but you responded slowly to some of the others. But we are trying to make a policy. And I am going to read a couple of these. If you can kind of give a general feeling, and then submit back in the record regarding Pittsburgh researcher Schatten's question. One is, how much money was spent on human embryonic stem cell research in 2005, and how much of that went to University of Pittsburgh researcher Gerald Schatten? Also, is his research on the Bush-approved stem lines as well as on primate embryos, and could you separate that funding for us? Also, of his $16.1 million, how does this compare to other people who have embryonic stem cell grants? If you could give us his rank in terms of grants for the research on monkeys and approved stem lines, and how many grants he has been awarded. And is he your top single grantee? Because his grant makes reference several times to this Korean research, which he was co-author of till he withdrew after the fraud became public. And also, will you give us the 2005 figures for ESCR grant awards? How many grants, total dollar amount, smallest grant award, and largest grant award? Because quite frankly, and your agency is doing oversight, this is just basic data, and it shouldn't take 2 years to get to this oversight committee to get basic data. Now, if you don't have it today, although we did submit these in advance. Dr. Battey. Let me do the best I can to answer your questions immediately. In fiscal year 2005, NIH supported about $40 million in research involving human embryonic stem cells. In fiscal year 2005, Dr. Schatten's NIH-supported research involving human embryonic stem cells was approximately $1.1 million. Getting to your issue about size of grants, Dr. Schatten is not the champion in terms of garnering NIH support for human embryonic stem cell research. Larger awards have been made, and in fact, an award of a little over $4 million was made to WiCell, which is a biotechnology firm associated with the University of Wisconsin, to form the National Stem Cell Bank, which is an effort to make the stem cell lines that are eligible for Federal funding more readily available to the research community. In fiscal year 2005, NIH supported 154 individual research projects involving human embryonic stem cells at the total amount of about $40 million. Of these, the smallest grant was $2,000 awarded to NGRI Intramural Scientists to conduct genome instability in cancer development research. The largest human embryonic stem cell project was the $4.2 million that I mentioned earlier awarded to the WiCell Research Institute. Mr. Souder. Thank you very much. That was helpful. Can you submit a full list of the grants for the record? Dr. Battey. The full list of the 154 individual research projects? Yes. Mr. Souder. In 2005? Dr. Battey. Yes. Mr. Souder. OK. Thank you very much. Yield to Mr. Cummings. Mr. Cummings. Thank you very much. Dr. Battey, I think it was you that said that one of the best ways to discover fraud in these instances is when you have to duplicate the research in another lab. Is that correct? Dr. Battey. Yes. If I can elaborate on that for just a moment. Mr. Cummings. Please do. Dr. Battey. When a major scientific breakthrough takes place, it generally has implications for research going on in a number of other independent laboratories. And one of the first things they will try to do to take the next step and build on that research is to take the protocol that was reported in the published literature to have given a specific result and reproduce that result. Now, when multiple laboratories around the world or in the United States cannot reproduce a major scientific finding, it rapidly falls into disrepute. Mr. Cummings. Now, you stated in your testimony that while the stem cell research fraud in South Korea is unacceptable, it doesn't reflect on the potential of human embryonic stem cell research one way or the other. Is that what you said? Dr. Battey. I am saying that the arguments for or against doing human embryonic stem cell research are not directly implicated by the--or directly influenced by the fraud that everybody agrees was inappropriate that took place in South Korea. Mr. Cummings. You know, the thing that has--I think you listened to the opening statements, and you heard Ms. Norton. And I think one of the major concerns here is, do you--I mean, are you a scientist? Dr. Battey. I am reported to be a scientist, yes. Mr. Cummings. OK. Well, I will take your word for it. Dr. Battey. My mother thinks I am a scientist. Mr. Cummings. I am sorry. Say that again? Dr. Battey. My mother thinks I am a scientist. Mr. Cummings. Your mother? Dr. Battey. Yeah. Mr. Cummings. OK. That is good. [Laughter.] Dr. Battey. She also thinks I am a doctor. Mr. Cummings. I guess the question becomes--I think at least two of you, and I know Mr. Waxman, referred to it, and others--this whole thing of fraud and whether the fraud in an area like this should then cause us not to go into that area. And then the chairman got very upset when we talked about--you all talked about the cardiology piece. But I guess the point is that you can have these problems. You are going to have problems as long as you have human beings doing things. The question becomes, do you stop going in the direction because of that research. Is that what you all are saying? Dr. Battey. My comment was that there is an enormous potential to improve the human condition through research that involves all types of stem cells. And it is my belief, and the belief of the National Institutes of Health, that we need to move forward and explore all avenues that are reasonable and ethically sound that have the potential to alleviate human suffering. Mr. Cummings. And when you see instances like California and Maryland moving toward funding this research, how does that affect the people in you all's shops? In other words, if you see States now moving toward that and you are, I guess, kind of standing on the sideline and watching, does that create concern for you all at all? Dr. Battey. My job as the Chair of the NIH Stem Cell Task Force, which is a role that I was asked to assume by the NIH Director, Dr. Zerhouni, in the summer of 2002, is to try to find areas within the President's policy where we can accelerate the pace of research using stem cells. And I think it is fair to say that there has been very significant progress made by support provided by the National Institutes of Health. As I mentioned, in the last fiscal year we have 154 research projects. We invested $40 million. And much has been learned about the fundamental events that drive cells to become specialized adult cell types. This is the information that will ultimately allow us to potentially generate cells for cell replacement third party in the laboratory; to potential mobilize endogenous populations of stem cells within patients to become these interesting cell types; or, ultimately, to understand the molecular mechanisms that determine this magical process of nuclear reprogramming whereby an adult nucleus in a specialized cell can turn back the clock and become a pluripotent cell nucleus, and in so doing, allow us the opportunity to generate pluripotent cells without the destruction of human embryos. Mr. Cummings. We have a tough time situation, but I have to ask you this one last question. You know, so you--based upon what you just said and your testimony, you don't see this area of research as some pie in the sky. And it has been implied that some of this research is just giving people false hope. You don't see that based upon your knowledge and expertise? Do you understand the question? Dr. Battey. I understand the question very well, I believe. I will say freely that the comments that have been made about therapies using adult stem cells and the therapies using embryonic stem cells at this time are 100 percent true. There are no therapies using human embryonic stem cell lines at the current point in time. Adult stem cells, in particular hematopoietic stem cells, stem cells of the blood-forming organ, the bone marrow, have been part of the research landscape for nearly 3\1/2\ decades. Human embryonic stem cells first became available to the research community in 1998, when James Thompson published his landscape paper. I think it is premature at this point in time to evaluate exactly what type of stem cell and in what way knowledge gleaned from studying that type of stem cell in 10, 20, or 30 years is going to inform the medicine of the future and empower the next generation of physicians. Mr. Cummings. And I imagine if we had taken that position in a lot of our science, we wouldn't be where we are today in various areas of science. Dr. Battey. It is unfortunate, but the progress of science is usually incremental. And we make slow steps forward, and it takes many, many of those slow steps over a long period of time, before we have even done the safety and efficacy testing in animal models that poise us to do the first experiments that involve human patients. And I am delighted to be joined here by my colleagues from Office of Human Research Protection, who see to it that we do these studies in people in a responsible fashion. You know, we are absolutely bound to do that, as human beings and as physicians. Mr. Cummings. Thank you very much. Mr. Souder. I really need to hold to the 5-minute rule because we have a lot of Members, and we are trying to reach a 5 p.m. deadline, and we have six witnesses on the second panel. Ms. Foxx. Ms. Foxx. Thank you very much. I want to ask Dr. Battey: Did SCNT create Dolly the sheep? Dr. Battey. Dolly the sheep was created by somatic cell nuclear transfer. That was in fact the time that we learned that an adult cell nucleus could be reprogrammed. That was the first demonstration that I am aware of in a mammal that was possible, although such experiments had been done in amphibians for decades. Ms. Foxx. Then what is the difference between somatic cell nuclear transfer and cloning? Dr. Battey. Somatic cell nuclear transfer is the process whereby the nucleus is removed from an oocyte and replaced by the nucleus from a somatic cell, a body cell. That is why it is called somatic cell nuclear transfer. When this procedure is done with the goal of creating an embryonic stem cell line that is genetically matched to an individual or has a specific genetic background, that term that is used for that is therapeutic cloning. When it is done with the intent of creating a new life through--all the way through gestation and having, in this case, a baby sheep born, in the case of Dolly, that is reproductive cloning. And, you know, the nomenclature--you mentioned that language can be very tricky. And the whole word ``cloning'' is a word that is a tricky word because it is used in many different ways. In my laboratory, we talk about cloning a cell line, which means basically taking a culture of cells and growing up a new culture from a single cell. We talk about cloning a recombinant DNA molecule, where we take a single recombinant DNA molecule and make 10 to the 8 copies of that molecule. And then here we talk about therapeutic cloning and reproductive cloning. And while they employ similar technologies at the beginning, they have different end points. Ms. Foxx. Well, I am curious about the phrase that you use, ``ethically sound.'' I wonder whose definition of ethically sound it is. And I will tell you what went through my mind when you said that, and I want to be very careful how I say this. I heard a presentation a couple of weeks ago by a physician, and he raised the issue of the Tuskegee experiments that were done. If there is anybody here who doesn't know those, those were experiments done on African American men in Alabama, I believe, or--I am not sure what State it was in, 40 years ago, 40 or 50 years ago, where they were injected with syphilis, I believe, and then studied for it. I wonder if those people said those studies were ethically sound. And would you feel that those were ethically sound studies? Dr. Battey. No. I would not feel they are ethically sound. And they led, in fact, to the creation of human subjects protection rules as we know them today. Ms. Foxx. OK. Then how would you define ethically sound if, in the process of doing embryonic stem cell research, you are destroying human life? How do you define ethically sound? Dr. Battey. That is the subject of a national debate at this time. And there are many different opinions on that subject that cut to the very heart of when people believe that life begins. That is a subject where the major religions of the world are divided. And it will be a subject that I predict will be a contentious subject that will need to be debated for the foreseeable future. Ms. Foxx. Mr. Chairman, that is the last question I had. But I would really like to go back to some of the testimony that might have been given around the Tuskegee experiments, and I will have a feeling that a lot of the scientists who were engaged in those used the very same language that you use. Mr. Souder. Mr. Waxman. Mr. Waxman. The Tuskegee experiments were reprehensible. They involved human subjects who were not informed of the nature of the experiments. As I understand it, they never were reviewed by any outside agency. And you indicated, Dr. Battey, that is why the whole protections for human subjects has been created, so that an institutional review board has to approve any kind of experiment to be sure that it is ethical and meets ethical standards. Is that correct? Dr. Battey. That is correct. Mr. Waxman. Now, a lot of people worry that embryonic stem cell research is going to be conducted. It is going to be conducted by private companies. If embryonic stem cell research is conducted by the Government, is there a greater chance that ethical standards will be met, that there are going to be--there will be greater scrutiny of all the procedures that go into that research? Dr. Battey. I think it is fair to say that there will be the same scrutiny that we have applied to other areas of biomedical research, with doubling scrutiny because of the respect that one has to have for the sensitive area of research where there is an enormous divide in our country. Mr. Waxman. Well, the American Society for Cell Biology emphasized the importance of public funding. And they at one point said that without Federal funding, the Nation's top academic researchers at universities, medical schools, and teaching hospitals cannot join in the search for cures, which means slower progress, and that the Government oversight will ensure that research complies with ethical guidelines. Do you agree with that statement, that last point, and how does it guarantee or ensure that research complies with ethical guidelines? Dr. Battey. We can insist that before Federal funds are expended, that proper oversight has taken place. And that in fact is done with all the research that involves human subjects, where the experiment must be reviewed by an institutional review board in the institution in question before such an experiment goes forward. Mr. Waxman. In your view, does the Korean scandal establish or suggest that the field of embryonic stem cell research is unique in being susceptible to scientific fraud and/or patient exploitation? Dr. Battey. Unfortunately, I am afraid that scientific fraud has been found in many areas of science, as I mentioned earlier. It is rare, but it happens in many different areas. And scientists need to be vigilant to try to prevent it. But I would emphasize that it is my sincere belief in my 23 years of experience as a scientist has taught me that the overwhelming majority of individuals engaged in biomedical research are sincere, hardworking, and would like nothing better than to see what they do in their laboratories lead to better cures and better health of the Nation. Mr. Waxman. Should women be allowed to donate eggs for purely research purposes under any condition? And if so, what should those conditions be? Maybe you want to---- Dr. Battey. I think that might be a better question for Mr. Schwetz to try to answer, if he would like to, or I will answer to the best of my ability if he would prefer. Mr. Schwetz. All we can say is that if in fact there is going to be research that involved eggs from donors, and this is research that is funded by HHS and doesn't involve the cell lines--it doesn't get outside of the cell lines that are acceptable for HHS-funded research, then all we can say is that we have a network in place through the institutional review board system that determines that these protocols must be reviewed, and they need to meet the standards that are set in our regulation. Mr. Waxman. Well, what if we changed the ban on this research through NIH and broadened it to further investigations using embryonic stem cells, does a--exploitation of women is a major and disturbing theme in the story of the Korean scandal. Would this be something that we could make sure is done appropriately, if a woman wishes to participate in donating an egg for research beyond stem cells that are available now? Mr. Schwetz. It is hard to know what is going to come up in the future. But based on what we know today, these--we are faced--this is an enterprise that is faced with a number of risks in research, and the possibility that there would be a problem with harvesting eggs from females is one of a number of risks that would be handled by the institutional review board system on a regular basis. So I don't think there are limitations in the regulations that would suggest we shouldn't go into this kind of research because we don't know how to handle it. Mr. Waxman. We don't know how to handle it until it is reviewed? Until some proposal is reviewed? Mr. Schwetz. That is correct. Mr. Waxman. OK. Thank you. Thank you, Mr. Chairman. Mr. Souder. I have a feeling that though Mr. Waxman and I may disagree fundamentally on where life begins and in embryonic research, if this were to go forward with congressional standards, I have a feeling that we would want more than an institutional review because that is partly what happened here. In other words, just trusting the university isn't going to cut it in something this controversial ethically. Is that---- Mr. Waxman. Well, I don't think an institutional review board is trusting the university, and maybe we can have the experts inform us on the subject. But I think an institutional review board is to oversee the work of the universities and their proposals when they evaluate the ethics of any experiment. Mr. Souder. This is important to clarify because we had it in the testimony in response to several questions. My understanding is that unless you feel there has been abuse, the research on whether there has been fraud, and the guidelines are standard, they submit. Then they do an internal review, and unless you feel something is wrong, you don't review it. Is that correct? Mr. Waxman. I think they have to review it in advance to prevent an abuse, not wait till---- Mr. Souder. They set the guidelines, but to make sure that the guidelines are being followed, it is self-reported unless somebody blows a whistle or you suspect something. Is that correct, Mr. Pascal? Mr. Pascal. Is your question to me? Mr. Souder. Yes. Mr. Pascal. I am sorry. Yes. We normally get complaints of allegations from individual scientists. Also, the institution is required to report to us when they get to the investigation stage. Mr. Souder. Thank you. Is that clarified? Mr. Waxman. Well, I think it is an answer, and I appreciate the answer. Thank you. Mr. Souder. OK. Ms. Schmidt. Ms. Schmidt. Thank you. I have a question. But before I ask my question, Ms. Foxx said that language is important. And Dr. Battey, this goes to you as well as the question. Language is important, and I don't think we should discuss the term ``religion'' when we are discussing when life begins because I have a very dear friend that is an atheist, and he believes the same as I do as to when life begins. And he doesn't believe in any God or in any religion. But having said that, I have been concerned about the issue of appropriate stem cell research for some time. In my days when I was in the Ohio Legislature, I actually went to the University of Cincinnati to find out exactly how they were handling this. And so I know that extrapolating information is important. And when I got here, I did some research, and I found out that this committee in its past has had a difficult time getting information from you. As you know, and as I found out, this subcommittee requested information from you in October 2002 seeking a detailed report providing comprehensive information on the medical applications of adult and embryonic stem cells, as well as cells from cloned embryos and aborted fetuses. The subcommittee received a response from you in June 2004, 20 months after its initial request, during which time the subcommittee staff continuously inquired about the status of this report, and subsequent chairmen's letters were sent seeking this material. And I have copies of them. Your reply to this oversight request, 20 months in the making, was completely insufficient and unresponsive to the plain meaning of the committee's request. Ultimately, you acknowledged this and apologized for the inadequacy of the response. But throughout this entire period, when Congress was seeking critical information about these very issues we are discussing today in 2006, information that would have been useful for complex policy decisions being faced by the Congress and our President, members and their staffs were unable to obtain the kind of accurate, timely, and up-to-date information from NIH necessary to do, quite frankly, the people's work. This happened on your watch. It seems only appropriate that while we are examining the problems in this research area, that you explain to this body why such critical information was withheld from Congress for so long. And the second part of that is: Will you be forthcoming when we ask for additional information in a timely manner and a comprehensive format in the future? Because I believe the public has a right to know. Dr. Battey. It is a fair question. I am very sorry that response was delayed the length of time that it was. But I must inform the committee that the NIH had developed its response within a few weeks of when the request was initially received. Once we develop a response, it is then subject to a clearance process in the Department of Health and Human Services over which I have no control. So yes, it was done on my watch, and I take responsibility for it. But aspects of that delay were beyond my control. And what I will tell you is that I will do what I can to get information to this subcommittee or any other subcommittee, factual scientific information, in as timely and accurate a fashion as the resources I have at my disposal allow me to do. But again, I say I am sorry you were without that information for a 2-year period. Ms. Schmidt. Well, I have a followup, sir. And again, I am new to this process. But information is key---- Mr. Souder. Mr. Schmidt, will the gentlelady yield a second? Ms. Schmidt. I would be honored, yes. Mr. Souder. And I will put your time back on. And if Ms. Norton and Ms. Watson will let me make a brief comment, that I appreciate your apology. Ms. Schmidt will have a followup question. But in the role of oversight in the U.S. Congress--and this is not directed at you--I am getting increasingly frustrated with this administration coming up with multiple excuses as to why they can't give us documents on this, on HHS, on the State Department, on the Office of Faith-Based, and other departments. We constantly hear, well, it has to be reviewed. We represent the American people. Two-year review is not acceptable. And I am not sure who we have to call in, whether we have to do this at the full committee level. But other subcommittees are having the same problem, in that exactly what takes 2 years of review to figure out, when we ask data and the data is coming over to us, what kind of review has to happen for elected officials to see the fundamental data. Then second, then we are told that the process of why it took 2 years is pre-decisional, as though there was some sort of a political discussion over what they were going to get us. And quite frankly, both at Department of HHS under this Secretary and at the State Department under multiple Secretaries, if it wasn't for individuals leaking us documents, we wouldn't know that when we get the documents, often, what has been taken out. And different agencies are saying--because we will make a document request. Then we will be told that this is all the documents. Then we will show the department--this happened three times in one State Department request. This, I think, dealt with Afghanistan. And it is getting increasingly exasperating. Then you are sent up here having to defend that. But the bottom line is: We need timely responses. The type of requests we made were basically factual requests. They shouldn't have had such a political screen. Even though we know this is a difficult subject, we are the same party. We know how difficult the subject is, but elected officials have a right to know what this data is. And the extra-exasperating part of this is that by the time we get the data, then we don't have the trust in the data. And then we--in the example of the State Department--had to request 10,000 documents. And then they came back and said the great cost. Well, we lost confidence in the trust of the Department. And HHS is headed this direction, too. If you can take this back. We will try to target our document requests if we get them in a timely fashion and get the documents that we requested. But if we don't get the documents requested in a timely fashion, we have to keep broadening the search because we are an oversight committee. And quite frankly, this happened under the last administration until the last stretch, and then they started sending over like truckloads of documents and taking forever to go through. But at least they were more forthcoming. And I appreciate your willingness to cooperate, and that this administration, hopefully at higher levels than yourself, will start to respond. But the frustration is building, and it is going to boil over if we can't figure out how to do it. So thank you for having the other data earlier. I yield to Ms. Schmidt. But sorry, I wanted to go on the record that this is far greater, even, than just his Department. We are having a tremendous problem in doing oversight right now for this very reason, getting 2 years and then not getting the--getting an incomplete amount, and not knowing what we are missing. That is because we don't know what has been taken out. Do you have any insight as to what took 2 years to review? Dr. Battey. No. Ms. Schmidt. Thank you, Mr. Chairman. As a followup, since you had to put this through a review process, who are the people we have to call to stop the delay in the review? Who-- give me the name, please, of the person that is accountable for the holdup in this document request because as the chairman said, it is not just Congress that has the right to know. It is the people that have the right to know. We represent the people of the United States. And we have the right to know information in a timely fashion, sensitive information on this issue, and this is a very controversial issue. If we don't have that information, we can't make the appropriate policy decisions that the people expect us to make. So who at your Department held this up for 2 years, so we can bring him in and ask why? Dr. Battey. I don't know. Ms. Schmidt. Can you find that out for us? Dr. Battey. I can try to find it out for you. Ms. Schmidt. Thank you, Mr. Chairman. Mr. Souder. Thank you. Ms. Norton. Ms. Norton. Mr. Chairman, I have a couple of questions, but I want to just say a word because both gentleladies have mentioned the word--the care we must take in language. And I want to second what they said. I want to say I appreciate that the gentlelady from North Carolina said she wanted to be careful about her language when she made analogies to the Tuskegee experiments involving living, Black men who were treated in a way that was emblematic of the way Black people were treated in the Southern States. And I just want to say for the record, for those of you who want to use those analogies into the African American experience, you are right. You had best be careful. Because I believe I speak for African Americans when I say we do not want anybody comparing Black people to human embryos. Mr. Chairman, I just want to say, because you have always been very remedy-oriented and I was a little surprised at what you said to the ranking member about BS'ing about analogies, we just heard some analogies that, frankly, I resented. But I really don't think you meant that we are only interested in the past. I have never seen you approach an issue that way. And I know you don't--you are not holding the hearing for political reasons or to keep any information we get from these witnesses to ourselves. And Mr. Chairman, if I can remind you, our own Chair, Mr. Davis, has said repeatedly that the Government Reform Committee, by the way, has the largest staff in the Congress of the United States because its writ is to investigate anything involving the Government. And I suppose the best indication of that, Mr. Chairman, for something that some would argue is totally outside our jurisdiction, is not only the hearings, not only the investigation, but the bill we passed on baseball. I mean, there is another committee that has primary jurisdiction over that matter, but the chairman brought forward his own bill on it. And I think when we are talking about this matter, we would want to be remedy-oriented. And in light of my work with you on this committee and my respect for your work on this committee, I know that you would want us, if we could uncover some remedies for adult stem abuses or embryonic stem abuses, to let everybody know about it. Let me have--let me ask a question to Mr.--Dr.--I think it is Battey. Am I pronouncing that Right? Dr. Battey. Yes, ma'am. Ms. Norton. And your role is the chair, of course, of this important task force on stem cell research. And Mr. Pascal, who is a lawyer, who speaks from another angle. First of all, I was relieved that both of you appear to have testified that we don't yet have this problem in this country, Dr. Battey, that the vast majority are honest, do not reflect on even the potential on the human embryonic cell research one way or another. You refuse to draw conclusions in advance. By the way, everybody, that is how the scientific--how the scientific method works. You come in with a hypothesis and you say, prove it one way or the other. Prevent it if you can. Mr. Pascal says virtually the same thing. Serious consequences if you had any particular case of--great majority of scientists here are dedicated. My question, and as far as you know have not been involved in anything like this kind of fraud and human rights violation. Let me ask you this. We talked about how fraud gets uncovered. Again, going back to scientists, who first uncovered this fraud? Dr. Battey. The initial---- Ms. Norton. In Korea? Dr. Battey. The initial allegations of fraud involved members of the research team in Korea. Ms. Norton. Very important point to put on the record, that it is a primary obligation of scientists themselves, as any ethical scientist moves forward, to replicate, to investigate, and moves forward in the spirit of great skepticism and that. But very important, as we seek guidance--at least people like me seek guidance--from the Federal Government, I don't know what form it should take to indicate how most fraud is uncovered, how most matters of this kind are uncovered. Are most of them brought forward by scientists, or was that unusual? Dr. Battey. I will yield to my colleague, Mr. Pascal, who probably knows better than I do, but would comment that in my experience generally, they are brought forward by individuals familiar with the research in question. Mr. Pascal. I would agree with that, that it is usually somebody who is in the laboratory or the department and is familiar with the research being done so they have enough knowledge to know that something is wrong. Ms. Norton. Whereas whistleblowers are uncommon in the Federal Government, that is the job of a scientist. And I am just pleased to hear that for the most part, it seems to be working in this country. I have a question that bothers me very much, though, and this involves the testimony of Mr. Schwetz--yes, of Mr. Schwetz, who said that--in page 4 of your testimony that the guidance, the stem cell guidance, does not generally meet the-- your definition, HHS definition, of human subjects research, and that is where you have offered guidance. Is that correct? Mr. Schwetz. Let me clarify because there are circumstances where research involving stem cells would be human research that would have to be reviewed and approved by an institutional review board, and you would have to have---- Ms. Norton. No. I am trying to establish--I am not trying to understand that. What I am trying to establish is that you have no guidance involving stem cell research. Mr. Schwetz. Yes. We do have guidance to the IRB and investigator community on their responsibilities if they are doing research involving stem cells. We do have guidance on that. Ms. Norton. So the guidance you have--the guidance you have offered would keep--in your judgment, would alert the scientific community that the kind of abuses we find in South Korea are not--or violate, I guess, your regulations and U.S. law? Mr. Schwetz. I am not sure I really understand your question. But there are some circumstances where fraud would represent risk to subjects. But there are other--to research subjects. There are other cases where fraud would not necessarily represent risk to subjects of research, but would have other implications for the quality of the data that are coming out of a laboratory. Guidance that we have put out regarding research involving human subjects and stem cell research is meant to be taken in the context of our broader regulations that tell investigators and the IRB community how to ethically review the research. Ms. Norton. Dr. Battey, one last question. Are you aware of the research--they have been very careful in how they have described it. I have read it. I have seen some of it on television involving rats, where rats have been injected with human embryonic cells. These rats were totally paralyzed before, and you see that the rats now move, awkwardly but amazingly and astoundingly. Without commenting on where this would lead because I don't think anybody knows where it would lead, and those who have been involved in this astounding, this startling, this amazing research are careful to say that these are rats only, but they were injected, were they not, with embryonic human stem cells? Dr. Battey. I believe that is correct. Ms. Norton. Very important to note since we had all kinds of opinion from non-scientists on the other side that there is no progress whatsoever. And Congress, however, knows best. Thank you very much, Mr. Chairman. Dr. Battey. I am. Could I add just one comment, though? It is not clear in what way the embryonic stem cells are enabling the rats to move their hind legs again. Ms. Norton. That is precisely why this work is going on, Dr. Battey. And in fact, you know, I mention it only because of the implication on the other side that there is no evidence of any results from embryonic--not because---- Mr. Souder. He just said there was no evidence. Ms. Norton [continuing]. And to their credit--to their credit, I have to say not because even those who are responsible for this---- Mr. Souder. Ms. Norton. Ms. Norton [continuing]. Scientific feat have said, hey, right around the corner, guess what? Everybody who is paralyzed is going to walk. All they have said is, we have a moral obligation---- Mr. Souder. He said---- Ms. Norton [continuing]. To proceed with this---- Mr. Souder. Ms. Norton, your time is well past. Ms. Norton [continuing]. With this kind of scientific research. And I agree they do. Mr. Souder. There is no evidence. What he said is there is hope in that research. His opinion gives hope, among other potential research. But there is no evidence. Ms. Watson. Ms. Watson. Thank you, Mr. Chairman. And thank you for this oversight hearing on the issue. In listening to the questions my colleagues have asked, there was a mention of the challenges of when life begins and so on. And in reading through the materials that were prepared for this hearing, it comes to light that the Korean government had approved of Dr. Hwang's research. Now, my question is: Do we have a bioethic commission similar within your Department, NIH or HHS? And do we run papers through it? When they have come up with a new piece of research, what do we do in response? Because in other countries, the ethics and morals and principles upon which they might do research can differ with the country, the culture, and tradition. And what do we do when we receive something called research and, you know, the controversy is over the fact that he misrepresented how he got the ova. So our concern should be: How do we protect our research and not allow this to happen? So can you respond? Dr. Battey. I will respond to the best of my ability. You are correct in pointing out that there are different national standards for providing Government funding or private funding for research in the area of human embryonic stem cells and human somatic cell nuclear transfer. Right now, the Department of Health and Human Services is operating under the President's policy as well as legislative language that is on the DHHS appropriation. The legislative language prohibits the use of DHHS funds for human embryo research. This is often called the Dickey language. The President's policy allows Federal funds to be used for human embryonic stem cell research so long as the embryo was created for reproductive purposes; was no longer needed for those purposes; informed consent was obtained from the donors; and no fiduciary incentive was provided for the donation of the embryo, with the condition that the inner cell mass be removed from the 5-day-old blastocyst on or before 9 p.m. Eastern Daylight time, August 9, 2001. So the policy under which DHHS currently operates is a policy that oversees the use of Federal funds for research. There is no national policy governing this research when the funds being used come from sources other than the Federal Government. And there is a patchwork of regulations in various States that provide different sets of guidelines for the legality or the provision of funds for this area of research. Ms. Watson. I think you make my point. And if we are results-oriented and remedy-oriented, and I too must agree with my colleague that our Chair seems to try to get to that point, and I appreciate that because that is the function of our committee, to have that kind of oversight. I would hope that you and maybe HHS could come together and talk about what the standard would be for Federal funding. We cannot control what other countries do. We look at their results and we look at the 50 States, and I know I chaired a committee where we dealt with this issue. We look at--as you say, they are a patchwork. But maybe we could develop some standards that would be guidelines. And when we read a piece of research that comes from another country, it has to go through a screening process before we make a big deal over it. You know, that is the way the Koreans dealt with this. The professor resigned. The doctor resigned, but he is going to go on with his research. So there is a cloud over whatever he produces. But I think we ought to set some standards where anything that comes from abroad flows through. And we ought to have a bioethics unit through which they go so we can discuss, you know, all these different theories and all these different ethics, and separating church from State, and, you know, what I believe in my religion versus what you believe. You are the scientist, and all. So I would like you to respond to that. I think I heard you mention that we needed something like that. Can you respond, please? Dr. Battey. You raise a very interesting issue. My response is that the fraud that was perpetrated in South Korea is reprehensible to everybody in the scientific community, every physician that I know in this country, and in fact, every responsible citizen that I know. It was wrong. It should never have happened. It was revealed because responsible individuals, subordinates within the laboratory, brought forward allegations. And in a very short amount of time, the problem was explored and revealed, and the fraud revealed to the entire world, and Dr. Hwang discredited. Had this individual not come forward, when it became apparent that no one else could reproduce his results, his results would have fallen into discredit. So we have a process that sorts out the truth from fabrication. And the linchpin of that process is reproducibility in another laboratory. And it isn't science if it can't be reproduced in another laboratory. Ms. Watson. Did you want to mention my suggestion that we look at the bioethics and try to work that piece out so that when you come forth with your empirical evidence that this can be duplicated, we have run it through these tests, including our discussion? Because I think there is a future for this research, and particularly here in this country. But we want to be sure that we can avoid the fraudulent practices up front. Dr. Battey. I think that is an interesting suggestion that should be considered by those who are higher ranking than I am in the administration. Ms. Watson. Well, I throw that out for whoever is listening. Maybe it will get into the press and somebody will start considering it. Thank you so very much, panel. Mr. Souder. I want to also thank this panel. We will most likely have some written questions. Hopefully we can get a timely response. We will leave the record open longer than 3 days. But if we can't, my inclination will be to write that we could not get clearance of the Secretary of HHS, OMB, and the White House for the answers because we will try to keep the questions narrow enough. When this hearing book comes out, it should include a fair amount of data with that. I also want to clarify two things that Ms. Norton said. She is correct that we do--in this committee, what I said is we look back on the past. We look in the past, at Katrina, at steroids, at whatever the issue is, to try to then develop and highlight what can be solutions that would then move to legislative committees. And so we have a future orientation by looking back on the past, and I didn't mean to imply we didn't have a future orientation. The second thing, but I do think the record needs to reflect this: This committee does have jurisdiction over both the oversight on baseball, but also the legislation. There was a difference of opinion, which we have worked out, that if the steroid was overseen by the Office of National Drug Control Policy, it would be our legislative as well as oversight. If it is DEA, it is Judiciary. If it is FDA, it is Energy and Commerce. The only question of where jurisdiction fell was on oversight, and that is really what we are battling over because we did have--in narcotics, we do have legislative as well as oversight. So I wanted the record to show that. I once again thank this panel. Thank you for your time, and I look forward to continuing to work with you. If the second panel could come forward. Dr. Battey. Thank you, Mr. Chairman. Mr. Souder. Thank you. Our second panel is Dr. Richard Chole, Lindberg professor and chairman of the Department of Otolaryngology--the subcommittee stands in brief recess. [Recess.] Mr. Souder. The subcommittee will come to order. Our second panel is Dr. Richard Chole, Lindberg professor and chairman, Department of Otolaryngology, Washington University School of Medicine, St. Louis; Judy Norsigian, executive director, Our Bodies Ourselves, co-author of ``Our Bodies, Ourselves''; Dr. Diane Beeson, professor emerita, Department of Sociology and Social Services, California State University, East Bay; Mr. Richard Doerflinger, deputy director of secretariat for pro-life activities, the U.S. Conference of Catholic Bishops; Dr. Debra J.H. Mathews, assistant director for science programs, the Phoebe R. Berman Bioethics Institute; and Joe Barden--Brown, excuse me, Parkinson's Action Network State coordinator of Texas. If you will each stand--well, why don't I swear the four of you in, and then I will catch the other two, maybe, by the time we do the third one. [Witnesses sworn.] Mr. Souder. Let the record show that Dr. Chole, Judy Norsigian, Richard Doerflinger, and Joe Brown all responded in the affirmative. We will swear in the other two witnesses before their testimony. We will start Dr. Chole. Thank you for coming. STATEMENTS OF RICHARD A. CHOLE, M.D., Ph.D., LINDBERG PROFESSOR AND CHAIRMAN, DEPARTMENT OF OTOLARYNGOLOGY, WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, ST. LOUIS; JUDY NORSIGIAN, EXECUTIVE DIRECTOR, OUR BODIES OURSELVES, CO-AUTHOR OF ``OUR BODIES, OURSELVES''; JOE BROWN, PARKINSON'S ACTION NETWORK STATE COORDINATOR, TEXAS; DIANE BEESON, M.A., Ph.D., PROFESSOR EMERITA, DEPARTMENT OF SOCIOLOGY AND SOCIAL SERVICES, CALIFORNIA STATE UNIVERSITY, EAST BAY; RICHARD DOERFLINGER, DEPUTY DIRECTOR, SECRETARIAT FOR PRO-LIFE ACTIVITIES, U.S. CONFERENCE OF CATHOLIC BISHOPS; AND DEBRA J.H. MATHEWS, M.A., Ph.D., ASSISTANT DIRECTOR FOR SCIENCE PROGRAMS, THE PHOEBE R. BERMAN BIOETHICS INSTITUTE, JOHNS HOPKINS UNIVERSITY STATEMENT OF RICHARD A. CHOLE Dr. Chole. Thank you, Mr. Chairman. I am Richard Chole. I am a professor at Washington University, but I am not representing Washington University but rather myself as a private citizen. I am a physician and a scientist. I have been funded for about 25 years by the institute, actually, that Dr. Battey directs. I am going to restrict my comments because of a lot of territory that has been covered already. Biomedical sciences are on a brink of a real revolution in the development of our science. This is the era of regenerative medicine. This is an exciting area. It is not necessarily a new area, but it is the result of incremental change over several decades. These incremental changes continue to occur. This might in the future allow us to not only ameliorate and manage disease, but actually cure some diseases. Organ transplants are an example of the beginning part of that. While the potential to help mankind is great, this new era poses some ethical and moral issues that we have never really encountered before that must be addressed not only by the scientists and physicians doing the research, but the public, probably more importantly by the public. The source of these regenerative cells for regenerative medicine will come from a variety of sources, and I would like to briefly discuss a couple--make a couple of comments about these sources. They might be embryonic, at the very earliest part of development. They might be fetal, at later parts of development. Or they may be adult, so-called adult, from the time of birth on. All of these sources of regenerative cells are called stem cells in that they can differentiate into any particular type of tissue. Some are more restricted than others. Embryonic stem cells, as we have been referring to them, come from the very earliest human embryos, those from the stage of fertilization, the zygote, through the blastocyst, about 5 to 9 days. In order to get the embryonic stem cells from these early embryos, the early human embryo must be destroyed. And this is a human being at the earliest stage of developmental life. Those inner cells, that inner cell mass, are the stem cells. They then are the ones that have been studied to lead to differentiation into different types of tissues. And indeed, scientists have been able to coax these cells to develop into a variety of types of tissues with potential uses for medical therapeutics. Research into these cells has been incremental, and unlike the hype in the popular press, these have not been major breakthroughs but incremental, very small breakthroughs, showing some difference between experimental and control animals. The pitfalls of this type of research are that by definition, it requires the destruction of a living human being at the embryonic stage. There are others as well. An embryonic stem cell is a different person. If you take the cells from that person and then put them into a different individual, there is a rejection process that goes on. That rejection would lead to the destruction of those cells unless the person was immunosuppressed by very powerful drugs. These cells by nature are vigorous growers. They don't know when to stop growing in many cases, and most of this research has resulted in implantation of these cells where they will grow rather uncontrollably into tumors called teratomas. This particular question has not been answered. These cells, once transplanted into an individual, may not--although they may function like a particular type of cell, may not be controllable. And in that environment, they may make too much of a hormone or not enough of the hormone. And there is no reason to--no evidence that these can really be controlled. So those are some potential problems with embryonic stem cells. One of those problems, that they may be rejected, may be surmounted, scientists say, by cloning them. Cloning, as we have heard, is the placement of a nucleus from the body into an empty egg from an egg donor. This develops into a zygote and then a blastocyst. If it were done in a human being, and it has never been done in a human being, this would recreate a living human being at the embryonic stage. The same ethical issues are faced by destroying this human being, albeit a cloned human being, if that were indeed possible. The advantage of this, theoretically, would be there would be no problem with cell compatibility. And I think that is why the excitement about this. The difficulties are many. These cloned embryos are not normal embryos. Dolly was not a normal sheep. It took 250-plus times to get a cloned embryo from a sheep to become Dolly the lamb. These cells have many, many different problems. They are defective embryos, and they are defective cells. These stem cells in cloned embryos are defective stem cells. So they are not normal at all. They are defective. And the idea of using a defective embryonic stem cell that really can't be controlled for medical therapeutics is pretty conjectural thinking and far, far off from current scientific knowledge. On the other hand, adult stem cells have their advantages and disadvantages as well. Adult stem cells, which are cells in our body--the most notable ones are in bone marrow, bone generation cells--have been shown to have more and more potential in development into specific tissue types. We have found recently that these cells can be caused to de- differentiate and become more like elementary stem cells, and can then be guided to develop into other types of tissue. This line of research has great promise because it is taken from--the cells are taken from the individual, and there are no compatibility or rejection problems when the cells are given back. It also has great potential because of the variety of diseases that can be treated with it, and in fact, we treat many diseases with it in common clinical practice, and clinical trials in humans for lupus and heart problems and other problems have showed very promising results. So the opportunities for adult stem cells are tremendous. There are disadvantages of adult stem cells, of course, in that they don't have all of the potential of an embryonic cell. But the problems can be overcome by further research into how these are developed. I would like to just make a comment about this question of when life begins. It is my contention that life begins at the fertilization of the egg and the development of the zygote. Every, single person in this room was once a zygote, a unique zygote. From the time of the fertilization of the egg until this moment, it has been a process of your development. The genes were set. You are a human being at that point. Medical science really has had little question about that, and I will read to you from a couple of textbooks that I took off the shelf at Washington University. The first one: ``The development of a human being begins with fertilization, a process by which the spermatozoon from the male and the oocyte from the female unite.'' Another textbook: ``Union of these gametes''--that is, the sperm and the egg--``during fertilization produce the zygote or fertilized ovum, which is the beginning of a new human being.'' Another one: ``Although life is a continuous process, fertilization is the critical landmark because under ordinary circumstances, a new, genetically distinct human organism is formed.'' So, really, there has never been any question in the teaching in embryology and the textbooks, maybe until the current era--these may be changed--that life begins at that point. Finally, I would like to make a comment about scientific hype and hype in the press about this. Mr. Souder. You need to summarize. We let you go over 2 minutes. Dr. Chole. OK. In the popular press, one might get the impression that paralyzed rats can walk again. This is incorrect. The studies have shown that when the experimental animals are compared to the control animals, both recover quite well in the experiments that she was citing, but the embryonic stem cell animals recover a little bit better. It is not the contrast that has been depicted in the popular press. This drama to this field has led some scientists to assume the position of celebrity. Scientists are not prepared to be celebrities. The scientist's role is to use cold, dispassionate analysis for his or her data, and then present it in an honest way. This element of celebrity has led to some distortion, maybe the distortion that led to the big scandal in Seoul. Thank you very much. [The prepared statement of Dr. Chole follows:] [GRAPHIC] [TIFF OMITTED] 29580.029 [GRAPHIC] [TIFF OMITTED] 29580.030 [GRAPHIC] [TIFF OMITTED] 29580.031 [GRAPHIC] [TIFF OMITTED] 29580.032 [GRAPHIC] [TIFF OMITTED] 29580.033 [GRAPHIC] [TIFF OMITTED] 29580.034 Mr. Souder. Thank you very much. Our next witness is Judy Norsigian. STATEMENT OF JUDY NORSIGIAN Ms. Norsigian. Thank you, Chairman Souder, Mr. Cummings, and members of the committee for the opportunity to speak. Judy Norsigian, executive director of Our Bodies Ourselves, a women's health education and advocacy organization, best known for our landmark book about women's health and sexuality, ``Our Bodies, Ourselves.'' At the outset, let me make clear, as I did at similar hearings 4 and 5 years ago, that my organization supports most embryonic stem cell research. We fully support ESC research that utilizes otherwise discarded embryos from IVF clinics. Thus, we do not agree with President Bush, for example. At the same time, we have serious concerns about a small subset of ESC research known as somatic cell nuclear transfer, more commonly referred to as research cloning, therapeutic cloning, or embryo cloning, as we have discussed today. My organization believes that our country should follow the prudent example already adopted by Canada and place a moratorium on all SCNT research until better safety data are available for some of the drugs used during multiple egg extraction procedures. There are several reasons for this position, but I will focus my remarks primarily upon our concerns regarding the risks of multiple egg extraction. And although women who undergo these procedures experience similar risks whether doing this for reproductive purposes, as is the case in an IVF clinic, or for research purposes, there is a critical difference. In the former instance, there is a 10 to 40 percent chance that someone, either the woman herself or another woman who is seeking to become pregnant at an IVF clinic, will be able to have a baby. That is a clear benefit. In the latter instance, when a woman undergoes these procedures solely for research purposes, the benefits to her or someone else are far more dubious at this time. Although some stem cell researchers have discussed this matter and even share our concerns, few have been willing to write about these issues. It may be that one positive outcome of the scandal in South Korea will be greater recognition of just how risky multiple egg extraction can be, as well as how easily frenetic competition and unjustified hype can lead to a more ready dismissal of these risks. In a recent issue of the American Journal of Bioethics, Stanford faculty David Magnus and Mildred Cho write the following: ``In a previous paper, we argued that there were risks associated with being an oocyte donor that were not given adequate attention in the informed consent process. This claim was based upon the informed consent documents by the South Korean researchers, an accompanying written description of the consent process, and their responses to questions posed.'' ``We argued that it would be easy to give short shrift to the small but serious risks that typically arise in a clinical setting precisely because these risks are not associated with the research aspects of oocyte donation.'' They go on to say that: ``The language used to describe scientific experiments also makes a great deal of difference in how accurately we convey the nature of stem cell research.'' Finally, they say, ``There is an important distinction between oocyte donation for research and live organ donation for transplantation. Live organ donation has a clearly established clinical value. Stem cell research does not. If that should change, we would agree that allowing women to donate oocytes for stem cell-based treatments would be permissible, if conducted properly. But allowing research donation to take place under these circumstances is an invitation for a new kind of therapeutic misconception, and should be avoided at this early stage of scientific development.'' The risks of multiple egg extraction are not well-enough studied, especially the risks associated with the drugs most often used to suppress a woman's ovaries. Lupron, generally referred to as leuprolide acetate, the generic term, is the drug I would like to focus on now. I have listed many of the adverse reactions in my testimony. These include: pituitary and liver function abnormalities; chronic joint, muscle, and bone pain; headaches and migraines; dizziness and blackouts; and serious memory disturbances and brain fog that persist well after the drug is discontinued. And we have had this from numerous reports. The FDA has received numerous adverse drug reports, and one of the things we are hoping we will see in the near future is a data mining analysis by scientists at the FDA to give us better direction on what kind of research we need to conduct. Lupron's use in the IVF setting is off-label use, and as former Chief Medical Officer Suzanne Parisian pointed out in her memorandum of February 2005, there are serious safety concerns yet to be resolved. Only well-designed research will answer critical questions that would then allow true informed consent for women undergoing multiple egg extraction procedures for any purpose. The drugs used to hyperstimulate the ovaries after ovarian suppression also have negative effects, most notably Ovarian Hyperstimulation Syndrome, a condition in which the ovaries continue to enlarge even after the eggs have been collected. Serious cases of this syndrome involve the development of many cysts and massive fluid buildup in the body. Rarely, death has resulted. The most recent one documented was in England in December. And it is not only the women undergoing the procedures who may be at risk from ovarian hyperstimulation. A very important article published in the past month by a Dutch team including medical and basic scientists suggests that infants may also suffer adverse consequences. This group has shown that female mice subjected to ovarian hyperstimulation had offspring with reduced birth weight as well as a high incident of congenital anomalies, including delayed formation of bones and an eightfold increase over background levels of cervical ribs, a condition which, when present in human infants, is associated with stillbirth and cancer. Should SCNT research go forward despite the concerns mentioned here, it will be left to women's health advocated to emphasize the inadvisability of women undergoing these procedures, especially younger women, whose risk of Ovarian Hyperstimulation Syndrome is actually greater than that for older women. Also, if such research does go forward, certain regulations and oversight of the research with respect to egg procurement are essential. I have listed seven here: that eggs should be obtained without any hormonal stimulation, since there is still insufficient information to get true informed consent. No relatives or coworkers of those doing research on eggs should be allowed to provide eggs for research. All medical expenses resulting from egg extraction for research should be covered; in cases where would be hormonally manipulated, longer-term healthcare coverage may be necessary to provide medical care for certain delayed health problems. Those performing egg extraction for research purposes should function totally separate from IVF services. And no research should be allowed on eggs or stem cell lines developed from eggs procured by means other than those just mentioned. This would avoid use of stem cell lines created in other countries or regions where safeguards to women's health might not be in place. We also believe that no patents should be allowed for products that might result from research on these eggs. Without such a policy, many therapies will likely never be accessible to the wider public. I can give you other such examples already. In addition, it would be extraordinarily difficult to avoid a problematic commercial market in women's eggs. And, of course, no payment to egg providers beyond direct expenses. We think both the researchers and the women who provide eggs in this case may be going to be making a sacrifice. So in conclusion, many scientists now acknowledge that individualized disease third parties will not research from embryo cloning research anyway, in part because of the need for massive numbers of eggs. The main benefit of embryo cloning would be the ab light to develop research models for studying particular diseases and conditions, but some of this type of work can be done already with otherwise discarded embryos that result from PGD, pre-implantation genetic diagnosis, testing. At this point in time, given both the known and unknown risks involved in multiple egg extraction procedures, these procedures should not be done solely for SCNT research. At the same time, we do support most embryo stem cell research. Thank you. [The prepared statement of Ms. Norsigian follows:] [GRAPHIC] [TIFF OMITTED] 29580.035 [GRAPHIC] [TIFF OMITTED] 29580.036 [GRAPHIC] [TIFF OMITTED] 29580.037 [GRAPHIC] [TIFF OMITTED] 29580.038 Mr. Souder. Thank you. I am going to move to Mr. Brown next because he has an airplane to catch. STATEMENT OF JOE BROWN Mr. Brown. Thank you, sir. Thank you, Mr. Chairman and members of the subcommittee, for inviting me today. My name is Joe Brown. I am a State coordinator for the Parkinson's Action Network, a founding member and vice president of Texans for Advancement of Medical Research, and a founding member of the Alliance for Medical Research. I have been an advocate for 20 years. As someone living with chronic disease, as a patient and an active caregiver, I was dismayed when I read the memorandum published by the committee that appeared to reach pertinent conclusions before this hearing was convened. It mistakenly concluded that somatic cell nuclear transfer [SCNT], is not supported by current science, and those who support this research have created an unjustified hype that plays on the hopes of suffering patients. I am not going to talk about theory and intellectual concepts. I am going to talk about life--my life, my wife's life, and the lives of you and your families. Having watched a genetic form of Parkinson's slowly steal the quality of life from my beautiful wife, I am concerned for my children and grandchildren. I have lived 70 years with a genetic heart condition that has sudden death as its most significant side effect. I have been fortunate enough to survive three heart attacks, bypass surgery, cardiac arrest, and cancer. I have reason to hope, especially since I have benefited from research that was thought to be wrong and unethical. I was the ninth person in the United States to receive a procedure that took me from being unable to walk from one room to another and days filled with countless hours of angina, to being able to carry my grandchild up a flight of stairs. This procedure, which actually gives the patient a heart attack to reduce obstructive heart muscle, was originated by a Swiss cardiologist. Switzerland didn't believe that giving heart attacks was ethical and wouldn't allow the procedure. The quality of my life was improved because Dr. Sigwart was forced to leave his country, just as American scientists are doing today in order to pursue stem cell research. So yes, as a patient, I do have hope that SCNT will succeed. But it is not unjustified hope. The breakthroughs have been exciting and amazing, but I recognize that sound research takes time. It took 52 years for the polio vaccine to get to market. I don't expect the scientific community to have these treatments or cures available in my lifetime, but if we don't start now and start solving the problems that we have with communication with each other, the cures won't be there for our children and grandchildren. When I visited the University of Texas Medical Branch in Galveston, scientists working with adult stem cells told me the most significant advances in adult stem cell research have occurred since embryonic stem cells were first isolated in 1998. The reason these scientists gave me is the embryonic stem cells are teaching them how to work with adult stem cells. To promote one form of stem cell research to the exclusion of another is counterproductive. I am astounded that there are those who don't recognize, while there may be fraudulent researchers, by definition, it is impossible for research in and of itself to be fraudulent. We don't stop basketball games when a player is called on a foul, nor do we stop having congressional sessions due to a Representative's misconduct. In the future, as the past, scientific fraud will be detected when peers are unable to replicate the results. And unfortunately, this self-policing mechanism has been disengaged in our country because the Federal Government isn't supporting the research. The fact that one scientist apparently procured egg donations without appropriate attention to the welfare of the patients doesn't mean that everyone else will do the same. Women have a right to donate eggs for the benefit of others when properly informed and with informed consent. It is incumbent on the United States, where both the quality of science and dignity of life are of uppermost concern in all of our minds, to take the lead in creating an appropriate framework for stem cell research while promoting and protecting its progress. On behalf of my family and the more than 1 million Americans with Parkinson's disease who would benefit from this research moving forward, I appreciate the opportunity to provide testimony to the subcommittee today. [The prepared statement of Mr. Brown follows:] [GRAPHIC] [TIFF OMITTED] 29580.039 [GRAPHIC] [TIFF OMITTED] 29580.040 Mr. Souder. Thank you, and whenever you feel you need to head to the airport---- Mr. Brown. It is going to be a little while. Mr. Souder. Now, I did the full introductions. But Dr. Beeson and Dr. Mathews, I need to swear you in yet. So if you will both stand and raise your right hands. [Witnesses sworn.] Mr. Souder. Let the record show that both Dr. Beeson and Dr. Mathews responded in the affirmative. And I will go to Dr. Beeson. STATEMENT OF DIANE BEESON Ms. Beeson. Thank you, Chairman Souder, Representative Cummings, and committee members. I appreciate being invited to testify today. My name is Diane Beeson. I am medical sociologist and professor at California State University, East Bay. For over 30 years, I have conducted research on social issues related to genetics and new reproductive technologies. I am a lifelong supporter of women's abortion rights, and I support embryonic stem cell research using embryos left over from IVR treatments. Like many social scientists, I have broad concerns related to the wisdom of developing cloning technologies. However, today I will focus on the most immediate social and ethical problems created by the demand for human eggs needed in experimental cloning, or SCNT, and that is the threat to women's health. Dr. Hwang and his colleagues used over 2,000 eggs without producing even one clonal embryo. This means we still do not know how many thousands or tens of thousands of eggs this research may require before achieving even preliminary success. Furthermore, it has become clear that payment, coercion, and lying were used to acquire the eggs that the media reported many women were eager to donate. Because egg extraction has come into expanded use since the birth of the Nation's first test tube baby in 1981, it is often assumed to be safe. Unfortunately, this is not the case. The fact is that egg extraction as currently practiced poses inadequately understood but clearly significant risks to the health of women. As you have heard from Ms. Norsigian, extraction of eggs involves introducing powerful hormones into a woman's body to manipulate it into producing many eggs at a time rather than the normal one or two. It often uses drugs not approved for this process, off-label, or drugs for which no long-term safety data are available. The FDA currently has on file over 6,000 complaints regarding Lupron alone, including 25 reported deaths. These complaints must be investigated and analyzed before more women are exposed to such potential dangers. We know that a coalition of Korean women's organizations is suing their Government for damage to the health of Korean egg providers. Scientific replication will not help these women. We should understand that the problems related to egg extraction are not unique to Korea. I have included with my testimony a letter from the mother of a young woman who died an agonizing death from Ovarian Hyperstimulation Syndrome in Dublin in 2003. Last April in London, another young woman dropped dead from a massive heart attack at a bus stop, linked directly to OHSS. While such events appear to be rare, it is possible that many deaths and other longer-term side effects have simply not been linked officially to the egg extraction procedures that preceded them. And if we look at the history of the use of hormones in this country, with DES particularly, we find that it often takes 30 years and hundreds of thousands of women being hurt by these things before they are taken off the market. A former Chief Medical Officer of the FDA, in a letter I have attached to my written testimony, reminds us that, ``Studies to date have not ruled out a possible link between stimulation drugs and increased risk of ovarian cancer.'' Another destructive consequence of ovarian hyperstimulation for women may be serious abnormalities in their children. Just this month, a new study reports that ovarian hyperstimulation treatment in mice results in several significant abnormalities in their later offspring. One in particular is associated, in humans, with an increased incidence of deformities and cancer. These concerns must be investigated before involving thousands of women in egg extraction purely for research purposes. Informed consent to participate in egg extraction is not possible without first following up on these serious warnings, particularly in the context of research. Informed consent is also made difficult by the fact that scientists and other proponents of SCNT have been reluctant to confront forthrightly the dangers related to egg extraction. Certainly in California this has been the case. This reluctance is a function of conflicts of interest resulting from recent legal changes affirming the right to patent genetically engineered life forms, and also allowing universities and their researchers to patent even those research products funded by the Federal Government. As a result, the field of embryonic stem cell research has become a virtual biotech gold rush. Under these conditions, it is highly unlikely that any regulation can adequately manage the ethical quagmire created by moving forward with SCNT. As a society, we are at a turning point in our relationship to science. We are being asked to make women the servants of biotechnology rather than insisting on a biotechnology that promotes the well-being of all people. For these reasons, until we understand more fully its human costs, I strongly urge your support for a moratorium on somatic cell nuclear transfer in both publicly and privately funded contexts. Thank you. [The prepared statement of Ms. Beeson follows:] [GRAPHIC] [TIFF OMITTED] 29580.041 [GRAPHIC] [TIFF OMITTED] 29580.042 [GRAPHIC] [TIFF OMITTED] 29580.043 [GRAPHIC] [TIFF OMITTED] 29580.044 [GRAPHIC] [TIFF OMITTED] 29580.045 [GRAPHIC] [TIFF OMITTED] 29580.046 [GRAPHIC] [TIFF OMITTED] 29580.047 [GRAPHIC] [TIFF OMITTED] 29580.048 [GRAPHIC] [TIFF OMITTED] 29580.049 [GRAPHIC] [TIFF OMITTED] 29580.050 [GRAPHIC] [TIFF OMITTED] 29580.051 [GRAPHIC] [TIFF OMITTED] 29580.052 [GRAPHIC] [TIFF OMITTED] 29580.053 [GRAPHIC] [TIFF OMITTED] 29580.054 [GRAPHIC] [TIFF OMITTED] 29580.055 [GRAPHIC] [TIFF OMITTED] 29580.056 [GRAPHIC] [TIFF OMITTED] 29580.057 [GRAPHIC] [TIFF OMITTED] 29580.058 [GRAPHIC] [TIFF OMITTED] 29580.059 [GRAPHIC] [TIFF OMITTED] 29580.060 [GRAPHIC] [TIFF OMITTED] 29580.061 [GRAPHIC] [TIFF OMITTED] 29580.062 [GRAPHIC] [TIFF OMITTED] 29580.063 Mr. Souder. Thank you very much for your testimony. We will now go to Mr. Doerflinger. Thank you very much for joining us. STATEMENT OF RICHARD DOERFLINGER Mr. Doerflinger. Thank you, Mr. Chairman. As we know, Korean researchers led by Dr. Woo Suk Hwang are now seen as having perpetrated a massive fraud, details of which have been ably described here by others. I think there are scientific, political, and moral lessons to be learned from this. Each point here is documented in my longer written statement I have submitted for the record. First, the scientific lesson: Cloning researchers must go back to the drawing board. After 8 years of effort to clone human embryos, no one has achieved even the first step in using this procedure for human treatment, so-called therapeutic cloning. Usually, fraud by one researcher does not discredit an entire field, but Dr. Hwang's studies were the field of allegedly successful human cloning for research purposes. If his research is a fraud, there is at present nothing left of that field. As the New York Times says, ``Cloning researchers are back to square one.'' This is, by the way, the third time in 8 years we have heard announcements of success in cloning human embryos for their stem cells, only to find the claim had little basis in fact. The other false starts, in 1999 and 2001, were by Americans. South Korea has no monopoly on misleading hype in this field. And let me just say, the word ``fraud'' is used, and it is perfectly appropriate. But Dr. Hwang did not start as a fraud. He started as someone trying to make this work. And after years of attempt, endangering the health of 100 women, thousands of eggs, creating hundreds of embryos in the lab, with those tens of millions of dollars and the full Government support of South Korea, just like everyone else, he failed. And that is why he was tempted, in his desperation, to commit fraud. He is the biggest fraud in this field, but the key word that is common to all the cloning researchers, is failure, failure, failure. And I heard some subcommittee members say, therefore, this is the very sort of thing the Federal Government has to get into funding. Attempts at therapeutic cloning in animals have also been discouraging. In several studies, researchers achieved any therapeutic goal only by implanting the cloned embryos in an animal's uterus and growing it to the fetal stage, then killing it for more developed fetal stem cells. Such fetus farming is now seen by some researchers as what they call the new paradigm for therapeutic cloning, and some State laws on cloning have even been crafted to allow such grotesque practices in humans. This would compound cloning's exploitation of women as egg factories by exploiting them as incubators for cloned humans as well. What are the implications of embryonic stem cell research in general? There is a distinction. It depends on whether cloning is essential for progress in embryonic stem cells. Cloning supporters used to say it is essential. Now that judgment is being reversed. Evan Snyder, in the New England Journal of Medicine, said cloning plays only a minor role. One recent overview called it a boutique science, at the fringe of stem cell biology. But if it is at the fringe, why not ban cloning now and have debates about the other issues in embryonic stem cells later? It remains possible that someone will solve these programs someday. But the prospect of making the cloning procedure efficient, separating it from the exploitation of women, and deriving cost-effective therapies from it in your lifetime seems remote. Second, the political lesson is that while there has been some misrepresentation in the scientific field, that has been magnified 10 times in the political field, in which in order to get public support in Government funding, supporters have acted more like snake oil salesmen than scientists at times, marketing the dream of miracle cures around the corner. Researchers are now issuing disclaimers to reduce people's unrealistic expectations about cures and looking for other people to blame. Some have even blamed the Bush administration for the failure and fraud in South Korea, as though by opposing cloning, you are some how making somebody else elsewhere do it wrongly. But no one has ever done it rightly. To blame unethical cloning in Korea on those who warned against doing it at all takes blame-shifting to new depths. The political lesson is that we need to be aware of the human cost of this agenda here and now, not only its alleged promise down the road. And we need to demand evidence for these grandiose claims. Third, and most importantly, a moral lesson: Utilitarianism is not useful. The ethic of the end justifies the means, and particularly the creation and destruction of life in the laboratory in order to achieve the miracle cures, has unfortunately become almost the official ethic of those seeking to justify this research. Government advisory panels have been forced to concede the early embryo is a developing form of human life, but used a cost/benefit analysis to argue that cures for born persons is worth more. As the chief ethicist at the NIH Human Embryo Research Panel said in 1994, ``If the end doesn't justify the means, what does?'' The problem is that the utilitarian ethic relativizes truth just as quickly as it relativizes lives. If human embryos are lives in a biological sense but lack the value of persons, could be sacrificed to help born patients who really matter, then the merely factual truth can sometimes be sacrificed by the same ethic for the higher truth of progress. Dr. Hwang did not violate the new ethic of his allies. He took it to its logical and inevitable conclusion. By demeaning life, we learn to demean truth, rendering science itself meaningless. If some researchers have not learned that important lesson, a sound ethical response must come from society and its policymakers. That response should begin with a complete ban on human cloning, and with legislation to prevent the mistreatment of women as egg factories for research, or as surrogate incubators for unborn children grown for their body parts. Only by respecting fellow human beings of every age and condition, and by refusing to treat them as mere instruments for achieving our research goals, will we promote a human progress worthy of the name. Thank you. [The prepared statement of Mr. Doerflinger follows:] [GRAPHIC] [TIFF OMITTED] 29580.064 [GRAPHIC] [TIFF OMITTED] 29580.065 [GRAPHIC] [TIFF OMITTED] 29580.066 [GRAPHIC] [TIFF OMITTED] 29580.067 [GRAPHIC] [TIFF OMITTED] 29580.068 [GRAPHIC] [TIFF OMITTED] 29580.069 [GRAPHIC] [TIFF OMITTED] 29580.070 [GRAPHIC] [TIFF OMITTED] 29580.071 [GRAPHIC] [TIFF OMITTED] 29580.072 [GRAPHIC] [TIFF OMITTED] 29580.073 [GRAPHIC] [TIFF OMITTED] 29580.074 Ms. Foxx [presiding]. Thank you. Dr. Mathews. STATEMENT OF DEBRA J.H. MATHEWS Ms. Mathews. Hello. Thank you very much for having me here today to share with you some of my thoughts. My name is Debra Mathews. I am a human geneticist by training. I also have training in bioethics and science policy. The first thing I want to say is that nothing--again, reiterate something that has been said here before today-- nothing that Woo Suk Hwang and his collaborators did or didn't do has disproved any of the basic tenets of human embryonic stem cell research, or taken away any of the potential of the research. When Woo Suk Hwang and his collaborators were doing this research, parallel research in the United States and other places did not stop. And the field did not crash and burn with the unfortunate and reprehensible activities that occurred with Woo Suk Hwang and his collaborator. Everyone in the embryonic stem cell research field knew that this would take a long time, and were surprised when Hwang came out with the results in 2004 and 2005. And their estimate turned out to be right. It is going to take time. This research did only begin in 1998, and that is not when scientists began attempting to do SCNT. That is when the first human embryonic stem cells were first derived. I am going to focus most of my comments on the question of fraud and the question of egg donation for research. My primary message here is that oversight is happening, and scientists care about developing oversight for this research. SCNT does raise the issue of egg donation for research purposes. Last summer the National Academy of Sciences issued guidelines, not only guidelines to govern the research, but also including guidelines relevant to tissue donors and egg donors. These guidelines have been broadly adopted by research institutions in the United States. And in addition to the national guidelines, the California Institute for Regenerative Medicine has recently issued interim guidelines that go above and beyond the protections provided by the National Academy's in their protection of egg donors. The California Institute for Regenerative Medicine has also partnered with the Society for Gynecologic Investigation on a scientific conference this May to focus on the risks of egg donation. I think that the message from the scientific community on this issue is very clear. They understand and are prepared to address the ethical issues raised by stem cell research, including egg donation for research purposes. With respect to the question of fraud, again, scientists do not embrace fraud. Scientists are slaves to their data, and they want the data to be as pristine as possible. And fraudulent data is of no use to the scientific community. The process of oversight associated with Federal funding provides some protection against breaches of scientific and ethical integrity. And the National Academy's guidelines add additional--which, as I mentioned, have been broadly adopted by research institutions in this country--provide additional oversight. The National Academy has also announced just recently that they will be setting up a committee for oversight of stem cell research. Given the lack of Federal funding and therefore the lack of oversight over this research, the National Academy has taken it upon themselves to set up an oversight committee specifically for stem cell research. The International Society for Stem Cell Research has also set up a task force to develop internal standards and ethical guidelines for embryonic stem cell research. And they will be presenting their findings at the annual meeting in the end of June/beginning of July. Finally, recently a group of approximately 60 scientists, ethicists, lawyers, and policymakers got together and developed a consensus statement providing recommendations for fostering the ethical and scientific integrity of embryonic stem cell research in a global context. And I can make those--all of these guidelines available to you. Scientists in the United States and around the world recognize both the promise and the controversy of stem cell research, and they are willing to step up to the plate and provide and accept ethical guidance to make sure that this science has the scientific and ethical integrity that is necessary. Thank you very much, and I would be happy to answer any questions. [The prepared statement of Ms. Mathews follows:] [GRAPHIC] [TIFF OMITTED] 29580.075 [GRAPHIC] [TIFF OMITTED] 29580.076 Ms. Foxx. Thank you. Dr. Mathews, I want to ask you one question. And we are nearly out of time, so we will try to make the questions short and the answers short, too. Has anyone ever created stem cells from cloned human embryos? Ms. Mathews. Not that I'm aware of. Ms. Foxx. OK. Has it been done even in monkeys? Ms. Mathews. Monkeys have been very difficult to clone, it is true. Ms. Foxx. OK. Is there anyone on the panel who disagrees with that answer? Dr. Chole. Monkey embryos have been cloned by Gerry Schatten in Pittsburgh. I don't--I am not sure if their stem cells have been extracted and cultured, but the embryos have been made. He is doing that for reproductive purposes for one way to protect endangered species. Ms. Foxx. Is he the person who was collaborating with Dr. Hwang in Korea? Dr. Chole. That is correct. Ms. Mathews. Is it the case that his embryos were basically in vitro embryos, or were they SCNT embryos? Dr. Chole. They are SCNT embryos. He has had some success with that. But they have not developed. They have implanted but not developed. Ms. Foxx. Dr. Chole, is there any biological difference between the entity that is created through so-called therapeutic cloning and reproductive cloning? Dr. Chole. No. Ms. Foxx. Thank you. OK. Ms. Norsigian, what have other countries done in the area on SCNT and egg donation, and what role did a concern for women's rights have in the passage of these laws? Do you think the conservative movement, as we are typically used to thinking about in the United States, was very active in getting these laws passed? And what reaction would you have to that? Ms. Norsigian. Well, I have to say I think it is unfortunate that the abortion debate and debates about the moral status of the embryo have clouded the discussion of cloning for research purposes that I focused on in my remarks. In Canada, interestingly enough, advocates, researchers, people with differing religious views, sat down and they actually came up with something that was acceptable to everyone, including the scientists. And they are putting a moratorium on SCNT. They are not saying never. They are saying, right now we have so much to learn with other embryo stem cell research. Some of the problems were just raised: the inability to control differentiation so you get the kind of tissue type you want, the inability to control tumorigenicity. I believe that only John Gearhardt and Johns Hopkins has avoided that by growing the mice embryos to the fetal stage so that germ line cells were harvested. These are not embryo stem cells. And in that instance, he was then able to eliminate the issue of tumorigenicity. There are many problems that I think may be able to be overcome. And those problems can be possibly solved, and you can use embryo stem cells that would be created from otherwise discarded embryos from IVF clinics. Though there are reasons, and I mention them, that make SCNT advantageous, I don't think they yet justify the known and unknown risks that we are asking women to undergo. There have been similar concerns expressed in England. And it is interesting. They are allowing this to go forward. The HFEA there has fairly strict regulations. But there is quite a controversy about this, particularly as we see some of the harms that women experience. Ms. Foxx. We don't have something--I am. Ms. Watson. Ms. Watson. Are you doing an overhead presentation? Is someone doing an overhead? Ms. Foxx. No. I don't think it is going to work. Ms. Watson. OK. I just want to thank the panelists, and of course the Chair. I think this has been very enlightening because it opens up a whole new, I would say, panoply of thought. And I think these are some of the issues that have been brought up today that we are going to have to deal with. I would definitely hate to see conclusions because of some of the fraud that has been perpetrated stop the serious research that can save lives, limbs, and improve physical conditions. I would hope that we could think through and work through the ethical issues, moral issues, and reach for a higher goal, and that is research that can improve the quality of life. So I would look forward--not a question, just a statement-- to further discussions of this type and to the panelists getting back to us with messages from your research as to the direction the Federal Government should take. With that, I want to thank you, Madam Chair, and I will have to leave. And thank you very much. Ms. Foxx. Well, Mr. Doerflinger, I want to share some information and then ask you a question. In the district that I represent, there is some absolutely fabulous and earth-shaking research going on, Baptist Medical Center, with the use of adult stem cells. The key researcher there said in front of me and another Member of Congress who was visiting there recently that--in response to a question about why he was not using--or why he did not advocate the use of embryonic stem cells, said that--voiced many of the issues that have been voiced here today, aside from--even aside from religious and ethical issues, that these lines of stem cells simply created more problems than they resulted in benefits from. He and his researchers are able to grow organs that are helping make massive changes in peoples' lives. And they are helping our military people by regeneration of limbs. Is it your experience, again, that many of the scientists are not using the embryonic stem cells not for religious purposes but because of scientific reasons, so that they do not have to ``cloud the issue'' by bringing that issue--by bringing the issue of religion into it? Mr. Doerflinger. Well, the ethical issue, which I agree with what was said here earlier about the ethical issue being far broader than any religious issue, is certainly a factor. But I also know of many researchers who do all of their work on non-embryonic stem cells simply because they are easier to work with, easier to control. In many cases, they do not require lengthy FDA approval because they are the patients' own cells. They are not rejected as foreign tissue. They are in plentiful supply and can be--the research is showing they can be multiplied for clinical use more effectively than used to be the case. And they are working. Last night, ABC had a premier of its--I guess a new series called ``Miracle Workers'' featuring a man whose blindness was cured by his sister's adult corneal stem cells. And researchers at the University of South Florida, I think, up at St. Elizabeth's Medical Center in Massachusetts, have all said, it is not that we object to the ethics of the embryonic cells, it is that these are working and we think they are going to work better. And I think it is important to put this in a context that even in the Clinton administration, the National Bioethics Advisory Commission said that they did realize there is an ethical problem here. They were willing to override the ethical problem because they thought that was the only way to go. But they said that the pursuit of embryonic stem cell research, even using embryos, spare embryos, from fertility clinics, would not be justifiable if there were less morally problematic alternatives available for pursuing the research. And I think researchers have shown over and over again that those alternatives are real. They are very promising. And in many cases, they may well make it unnecessary for us to face these terrible ethical dilemmas. Ms. Foxx. Thank you very much. I believe that--Mr. Brown. Mr. Brown. I would just like to make a comment as a patient and as a patient advocate. I heard earlier that there are 60 adult cell cures that have been put in place, some of which I am aware of. One of them that was mentioned was Parkinson's. First, I question if the acid test has actually been made of replication. I know on some of it, it has--leukemia, for instance. The first time I heard about the Parkinson's was 2003. I know of no Parkinson's patient who is waiting for embryonic stem cells. If adult stem cells in truth were doing the job, I would be one of the happiest people in the world because I would see my wife of 44 years being able to walk 24 hours a day again. So I think that there is--and I believe that there is a tendency to overstate a great deal of what this science has and has not accomplished from both sides of the issue. I believe there is a great deal of misstatement, a great deal of miseducation--which I think it is very important that we educate. And what I would like to see is a more civil building of consensus and compromise to allow all of this research to go forward; that we close no doors, and see where science can take us. Ms. Foxx. Thank you all very much for being with us today. The hearing is adjourned. 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