SPEAKERS CONTENTS INSERTS
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2005
PAIN OF THE UNBORN
HEARING
BEFORE THE
SUBCOMMITTEE ON THE CONSTITUTION
OF THE
COMMITTEE ON THE JUDICIARY
HOUSE OF REPRESENTATIVES
ONE HUNDRED NINTH CONGRESS
FIRST SESSION
NOVEMBER 1, 2005
Serial No. 109–57
Printed for the use of the Committee on the Judiciary
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Available via the World Wide Web: http://judiciary.house.gov
COMMITTEE ON THE JUDICIARY
F. JAMES SENSENBRENNER, Jr., Wisconsin, Chairman
HENRY J. HYDE, Illinois
HOWARD COBLE, North Carolina
LAMAR SMITH, Texas
ELTON GALLEGLY, California
BOB GOODLATTE, Virginia
STEVE CHABOT, Ohio
DANIEL E. LUNGREN, California
WILLIAM L. JENKINS, Tennessee
CHRIS CANNON, Utah
SPENCER BACHUS, Alabama
BOB INGLIS, South Carolina
JOHN N. HOSTETTLER, Indiana
MARK GREEN, Wisconsin
RIC KELLER, Florida
DARRELL ISSA, California
JEFF FLAKE, Arizona
MIKE PENCE, Indiana
J. RANDY FORBES, Virginia
STEVE KING, Iowa
TOM FEENEY, Florida
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TRENT FRANKS, Arizona
LOUIE GOHMERT, Texas
JOHN CONYERS, Jr., Michigan
HOWARD L. BERMAN, California
RICK BOUCHER, Virginia
JERROLD NADLER, New York
ROBERT C. SCOTT, Virginia
MELVIN L. WATT, North Carolina
ZOE LOFGREN, California
SHEILA JACKSON LEE, Texas
MAXINE WATERS, California
MARTIN T. MEEHAN, Massachusetts
WILLIAM D. DELAHUNT, Massachusetts
ROBERT WEXLER, Florida
ANTHONY D. WEINER, New York
ADAM B. SCHIFF, California
LINDA T. SÁNCHEZ, California
CHRIS VAN HOLLEN, Maryland
DEBBIE WASSERMAN SCHULTZ, Florida
PHILIP G. KIKO, General Counsel-Chief of Staff
PERRY H. APELBAUM, Minority Chief Counsel
Subcommittee on the Constitution
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STEVE CHABOT, Ohio, Chairman
TRENT FRANKS, Arizona
WILLIAM L. JENKINS, Tennessee
SPENCER BACHUS, Alabama
JOHN N. HOSTETTLER, Indiana
MARK GREEN, Wisconsin
STEVE KING, Iowa
TOM FEENEY, Florida
JERROLD NADLER, New York
JOHN CONYERS, Jr., Michigan
ROBERT C. SCOTT, Virginia
MELVIN L. WATT, North Carolina
CHRIS VAN HOLLEN, Maryland
PAUL B. TAYLOR, Chief Counsel
E. STEWART JEFFRIES, Counsel
HILARY FUNK, Counsel
KIMBERLY BETZ, Full Committee Counsel
DAVID LACHMANN, Minority Professional Staff Member
C O N T E N T S
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NOVEMBER 1, 2005
OPENING STATEMENT
The Honorable Steve Chabot, a Representative in Congress from the State of Ohio, and Chairman, Subcommittee on the Constitution
The Honorable Jerrold Nadler, a Representative in Congress from the State of New York, and Ranking Member, Subcommittee on the Constitution
WITNESSES
Dr. Sunny Anand, Director, Pain Neurobiology Laboratory, Arkansas Children's Hospital Research Institute, and Professor of Pediatrics, Anesthesiology, Pharmacology, and Neurobiology, University of Arkansas College of Medicine
Oral Testimony
Prepared Statement
Dr. Jean Wright, Professor and Chair of Pediatrics, Mercer School of Medicine
Oral Testimony
Prepared Statement
Dr. Arthur Caplan, Director, Center for Bioethics, and Chair, Department of Medical Ethics, University of Pennsylvania
Oral Testimony
Prepared Statement
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Ms. Teresa S. Collett, Professor of Law, University of St. Thomas School of Law
Oral Testimony
Prepared Statement
APPENDIX
Material Submitted for the Hearing Record
Appendix to the Prepared Statement of Teresa S. Collett, Professor of Law, University of St. Thomas School of Law: Fetal Pain Legislation: Is it Viable? Pepperdine Law Review. Vol. 30:161, 2003
Appendix to the Prepared Statement of Teresa S. Collett, Professor of Law, University of St. Thomas School of Law: The Science, Law, and Politics of Fetal Pain Legislation. Harvard Law Review. Vol. 115:2010 2002
Prepared Statement of the American College of Obstetricians and Gynecologists
PAIN OF THE UNBORN
TUESDAY, NOVEMBER 1, 2005
House of Representatives,
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Subcommittee on the Constitution,
Committee on the Judiciary,
Washington, DC.
The Subcommittee met, pursuant to notice, at 4 p.m., in Room 2141, Rayburn House Office Building, the Honorable Steve Chabot (Chair of the Subcommittee) presiding.
Mr. CHABOT. The Committee will come to order. If the witnesses would like to make their way up to the table as I begin my opening statement here.
This is the Subcommittee on the Constitution. I am Steve Chabot, the Chairman. Congressman Nadler is the Ranking Member. He will be here very shortly.
The House Constitution Subcommittee convenes today to consider the ability of the unborn to experience pain and the constitutionality of informed consent laws requiring abortion providers to provide pregnant women with information on pain of the unborn.
As President Ronald Reagan stated, ''Medical science doctors confirm that when the lives of the unborn are snuffed out, they often feel pain, pain that is long and agonizing.''
The topic of pain of the unborn, including whether, how early and to what extent an unborn child feels pain, ignites heated debate, yet 77 percent of the individuals surveyed in an April 2004 Zogby International poll favor a law requiring that women who are 20 weeks or more along in their pregnancy be given information about pain of the unborn before having an abortion.
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Addressing this issue is the Unborn Child Pain Awareness Act, which was introduced by Representative Chris Smith and referred to the Energy and Commerce Committee. H.R. 356 defines a pain-capable unborn child as, ''an unborn child who has reached a probable stage of development of 20 weeks after fertilization.'' The bill requires an abortion provider or his agent to provide a pregnant woman with information on pain of the unborn and anesthesia prior to aborting an unborn child capable of feeling pain.
H.R.356 would apply to the approximately 15,000 to 20,000 abortions that are performed each year in the United States on unborn children who are 20 weeks or more past fertilization.
Even individuals in the pro-abortion community recognize that women should be provided information on pain of the unborn. Nancy Keenan, president of NARAL Pro-Choice America, stated that NARAL would not oppose the Unborn Child Pain Awareness Act because women deserve access to this relevant information.
A discussion of pain of the unborn must begin with establishing what the words ''feels'' and ''pain'' mean. While some physicians define ''feels'' to require consciousness, others argue that observed physiological and behavioral responses to stimuli are reliable indicators of pain.
Because the unborn are incapable of verbal expression, the evidence for pain of the unborn must be based on anatomical, functional, physiological and behavioral indicators that are correlated with pain.
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The pain of the unborn is not lessened by maternal anesthesia. Anesthesia given to a mother has little or no effect on her unborn child.
Our witnesses today will discuss the unborn's anatomical development, physiological responses to painful stimuli, and, ability to experience pain, perhaps even greater pain than that experienced by older infants, children or adults. They will explain how the evidence supports the conclusion that the unborn experience pain by at least 20 weeks gestation, and perhaps even earlier.
Information on pain of the unborn is relevant to a woman's decision of whether to abort her child. Informed consent provisions that require physicians to provide women with information on pain of the unborn are consistent with the Supreme Court's abortion jurisprudence. In Planned Parenthood v. Casey, the Supreme Court upheld Pennsylvania's informed consent provisions that required an abortion provider to notify the pregnant woman of information on gestational age, fetal descriptions, the nature and risks of the procedure, child support, and abortion alternatives.
Seven Justices, Supreme Court Justices, voted to uphold these provisions. According to the plurality opinion, ''In attempting to ensure that a woman apprehends—or comprehends the full consequences of her decision, the State furthers the legitimate purpose of reducing the risk that a woman may elect an abortion only to discover later with devastating psychological consequences that her decision was not fully informed. If the information the State requires to be made available to the woman its truthful and not misleading, the requirement may be permissible. We also see no reason why the State may not require doctors to inform a woman seeking an abortion of the availability of materials relating to the consequences to the fetus, even when the those consequences have no direct relation to her health.''
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Information on pain of the unborn such as that included in the Unborn Child Pain Awareness Act, requires abortion providers to notify pregnant women of truthful information that is not misleading. The requirement to provide information on the pain of the unborn to pregnant women will enable these women to better apprehend the full consequences of their decisions. Such a requirement is fully consistent with the Constitution.
My time has expired.
The gentleman from New York is recognized for 5 minutes for the purpose of making opening statement.
Mr. NADLER. Thank you, Mr. Chairman. I want to join you welcoming our panel today.
Mr. Chairman, while we are often at odds on issues relating to abortion, I think we all agree that informed consent is part of any meaningful definition of choice. That is why I have long supported educational programs that provide young people with the information they will need in life to make intelligent and responsible decisions about their health, about family planning, and so that they can become responsible citizens.
I do have to admit some trepidation, as I have mentioned in the past, when Congress starts playing doctor, or, in this case, neurologist. I can recall the last time Members of Congress attempted to play neurologist, making off-the-cuff diagnoses of a patient they had never seen and attempting to codify their understanding of that particular patient's condition, the entire affair was an embarrassing fiasco for this institution. It led some of the leaders of this House and the other House denouncing—I am sorry, denying, that they have said what they have said, and I hope that this fiasco will never be repeated.
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The last time Professor Caplan was here to testify before our Committee, the markup of the bankruptcy bill went late, and we had to cancel the hearing. Later that evening, without the benefit of a hearing, the House passed legislation dealing with the Schiavo case. That was three bad calls in the matter of a few hours. I would hope that we might have learned something from that experience.
We are not, after all, considering this issue in a vacuum. This discussion is not purely an academic exercise with respect to when a fetus feels pain. We are not simply reviewing the salience to satisfy our curiosity.
Although it is not within our Committee's jurisdiction, it is no secret that our colleague, the gentleman from New Jersey, has introduced a bill that would require health care providers to read a script, a script written into the legislation verbatim, stating as facts certain views on fetal development and the question of pain, facts as stated by Congress which may or may not necessarily agree with the latest scientific determinations, especially as those determinations may change from time to time.
This is an area of active scientific research, and there is no clear consensus within the scientific community on a particular conclusion. I am deeply concerned at the prospect that the Congress settling scientific debates by legislative fiat, which reminds me of the Supreme Soviet decision in Lyshenko affair—and they made a mistake on that one. Congress has already demonstrated that it is not particularly good at that. We should be supporting free inquiry, scientific research and the open and healthy doctor-patient relationship.
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I have no doubt that all of our witnesses are sincere in their views. That does not mean they are all correct in their views. I know that Dr. Anand has published his work in peer-reviewed medical journals, has had researchers who have come to very different conclusions. Unfortunately the minority is only permitted one witness, so the deck is stacked in a way that is not particularly conducive to thoughtful inquiry. We could not call here scientists who have reached different conclusions than Dr. Anand.
We have invited Dr. Caplan, because he is one of the Nation's most respected medical ethicists, in the hope that he would be able to provide the Members of this Committee with some guidance on how to approach these issues.
No one should, however, mistake today's hearing for the sort of vigorous inquiry that is the hallmark of proper scientific inquiry. Congress is not very good at doing science, and the manner in which we conduct our deliberations is one part of the reason.
I want to welcome our witnesses. I look forward to your testimony.
Thank you, Mr. Chairman. I yield back the balance of my time.
Mr. CHABOT. Thank you very much.
I would like to introduce our distinguished panel here this afternoon at this time. Our first witness is Dr. K. S. Anand. Dr. Anand is currently appointed as a tenured professor of pediatrics, anesthesiology, pharmacology, neurobiology and developmental sciences in the College of Medicine, University of Arkansas, for Medical Sciences, and is the first recipient of the Morris and Hettie Oakley Endowed Chair in Critical Care Medicine. He has established the pain neurobiology laboratory in Arkansas Children's Hospital Research Institute in Little Rock, Arkansas.
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Dr. Anand received his research training as a Rhodes Scholar at the University of Oxford. He completed fellowship training in pediatric critical care medicine at the Massachusetts General Hospital and was appointed as a assistant professor at Emory University.
Dr. Anand has published more than 200 peer-reviewed articles in addition to numerous review articles, book chapters and editorials, and has edited five books and journal issues. His research has received widespread recognition, and he has received numerous extramural grants to support his research activities from the NIH, National Endowment for Health, Blowitz-Ridgeway Foundation and other sources. And we very much appreciate you being here, Doctor.
Our second witness is Dr. Jean Wright. Dr. Wright is the Executive Director and Vice President of Operations for Children's Hospital and Women's Institute at Memorial Health University Medical Center in Savannah, Georgia. She is also Professor and Chair of Pediatrics for Mercer School of Medicine. Dr. Wright is trained in pediatrics and anesthesia, board-certified in both, and certified in the subspecialties of pediatric critical care and anesthesia critical care.
Dr. Wright has been in academic medicine over 20 years, and prior to going to Savannah served at Emory University and Children's Health Care of Atlanta. Dr. Wright currently chairs the Federal Advisory Committee on Fetal Alcohol Syndrome for the CDC. And we welcome you very much as well, Dr. Wright.
Our third witness is Dr. Arthur Caplan. Dr. Caplan is currently the Emanuel and Robert Hart Professor of Bioethics, Chair of the Department of Medical Ethics and the Director of the Center For Bioethics at the University of Pennsylvania in Philadelphia. Prior to going to Penn in 1994, Dr. Caplan taught at the University of Minnesota, University of Pittsburgh, and Columbia University. He was the associate director of the Hastings Center from 1984 to 1987.
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Dr. Caplan is the author or editor of over 25 books and over 500 pages in refereed journals of medicine, science, philosophy, bioethics and health policy. He has served on a number of national and international committees and consulted with many corporations, not-for-profit organizations and consumer organizations.
Dr. Caplan is the recipient of many awards and honors and holds six honorary degrees from colleges and medical schools. He is the fellow of the Hastings Center, the New York Academy of Medicine, College of Physicians of Philadelphia, and the American Association For the Advancement of Science. And we welcome you here as well, Dr. Caplan.
Our final witness is Professor Teresa Stanton Collett. From 1990 through 2003, Professor Collett was a professor of law at South Texas College of Law, where she taught various legal courses. Since 2003, she has served as professor of law at University of St. Thomas College of Law, teaching bioethics, property, and professional responsibility. Professor Collett has also served as a visiting professor at Notre Dame Law School; Washington University School of Law in St. Louis, Missouri; the University of Texas School of Law; the University of Houston Law Center; and the University of Oklahoma College of Law.
Prior to joining South Texas College of Law, Professor Collett was affiliated with the law firm of Crowe & Dunleavy in Oklahoma City, Oklahoma. And we welcome you here as well, Professor.
I want to thank all the witnesses for being here this afternoon, and we want to make sure that you are aware that your testimony will be permitted for 5 minutes, and we actually have a lighting system. When the red light comes on, that means your 5 minutes is up. I won't gavel you down immediately, but we would ask you to keep within that as much as possible. A yellow light will come on letting you know you have a minute to wrap up, and the green light will be on for 4 minutes.
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It is also the practice of the Committee to swear in all witnesses appearing before it, so if you would each please stand and raise your right hand.
[Witnesses sworn.]
Mr. CHABOT. All witnesses have indicated in the affirmative.
Without objection, all Members will have 5 legislative days within which to submit additional materials for the record.
And, Dr. Anand, you are recognized for 5 minutes.
TESTIMONY OF SUNNY ANAND, DIRECTOR, PAIN NEUROBIOLOGY LABORATORY, ARKANSAS CHILDREN'S HOSPITAL RESEARCH INSTITUTE, AND PROFESSOR OF PEDIATRICS, ANESTHESIOLOGY, PHARMACOLOGY, AND NEUROBIOLOGY, UNIVERSITY OF ARKANSAS COLLEGE OF MEDICINE
Dr. ANAND. Thank you. I appreciate the invitation to testify before this Committee. I come to you as a researcher in the development of the brain, particularly as it relates to pain perception during fetal and neonatal life. I am not here as a practitioner for procedures required for termination of pregnancy or anesthetic practices related to those procedures.
I think the evidence for and against fetal pain is very uncertain at the present time. There has been a recent attention on this based on a review article that was published in the Journal of the American Medical Association on August 24th. And I will first try to bring up some points to critique that article.
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That article was published by Susan Lee and her colleagues at the University of California, San Francisco, and they have done a systematic review of the published literature related to this subject.
First of all, they present pain as a hard-wired system, whereby pain impulses are conducted from receptors through nerves and nerve pathways until so-called perception occurs in the sensory cortex. This is an incorrect view of pain, which is rather outdated. For the last 40 years, medical research has shown, beginning from the gate control theory of pain, that pain reception occurs within a multilayered system with numerous elements of nerve fibers and cells, the functions and the characteristics of which will change depending on the type of pain, the context in which it occurs, as well as other cognitive and behavioral demands at that time, so that the processing of pain and indeed perception of pain doesn't simply occur in the sensory cortex. It can occur at various different levels within the nervous system.
Second, Lee and colleagues presume that the structures used for pain perception in adults are the very same structures used during fetal and neonatal life. The lack of development of these structures is then taken as proof that the fetus does not—or the preterm neonate—would not feel pain until 29 to 30 weeks period of gestation. This is again a flawed line of reasoning.
Many years of careful research in which I have participated has shown that the neonate, or the fetus, is not a little adult;that the mechanisms and structures used for pain processing are very different at different stages of development. Indeed the nervous system will use the elements available at that time, at a particular stage of development, to transduce external and internal stimuli, and pain is an inherent, innate part of this system.
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These neural elements during development may not survive, may not be maintained until maturity. They may have only a transient role in conducting pain or pain-related information from the periphery to the central nervous system.
Lastly, I beg to differ with the contention that the perception of pain occurs only in the sensory or the somatosensory cortex. For example, in conscious adults, if you stimulate the sensory cortex, or if you cut it out completely, it will not alter pain perception. Stimulation does not produce pain perception; removing the sensory cortex does not block pain perception.
So if the viability of the sensory cortex is not a necessary criterion for pain perception in adults, why should that be a criterion for fetus and preterm infants and neonates?
Despite this caveat, more recent research shows that there is, indeed, alteration in the activity of cortical centers related to sensory perception, but this may have more to do with the content, but not the context, of the pain experience that is being transduced.
Lastly, I would like to identify that there was ambiguous methodology followed in this review whereby 2,100 articles were obtained from PubMed through a detailed search strategy. And the subsequent disconnect of selecting what evidence to include in the data synthesis did not follow the methods of a systematic review. If I were to review this systematic review, it cannot be replicated, and therefore it calls into question the scientific validity of this approach.
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I appreciate the opportunity to present my views.
Mr. CHABOT. Thank you very much, Doctor, and we can get more information in the questioning period, of course.
[The prepared statement of Dr. Anand follows:]
PREPARED STATEMENT OF SUNNY ANAND
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Mr. CHABOT. Dr. Wright, you are recognized for 5 minutes.
TESTIMONY OF JEAN WRIGHT, PROFESSOR AND CHAIR OF PEDIATRICS, MERCER SCHOOL OF MEDICINE
Dr. WRIGHT. Thank you, Mr. Chair, Members of the Committee.
As you heard my introduction, I spent my career in the care and anesthesia of critically ill children, and I have testified now twice on this subject here on the Hill as well as testified in many States. The opinions I present today are my own, and I don't represent any group during this time.
It is interesting. My own personal sojourn as a clinician parallels a lot of the changes that we are talking about with respect to fetal pain. When I began over 25 years ago in my practice, I would take a premature baby to the operating room, paralyze that infant, not give it any pain medication, and we would do a heart operation or abdominal operation simply because we felt the child was too sick for anesthesia. Never in our clinical dialogue did we ever think the child doesn't feel pain. We just felt we couldn't give an anesthetic in a safe manner.
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By the end of the '80's, data had come out from Dr. Anand, from Dr. Nancy Green, from Paul Hickey, from Glover, from many others that showed us, yes, we could administer anesthetics safely, and not only could we do it safely, it would change the outcome of that child.
You know, it then became apparent to us, no wonder many of these preterm babies when they came back to the neonatal intensive care unit looked so devastated. In fact, many of them didn't survive, which at that time sort of reinforced our presumption that they were too sick for anesthesia. But with time, with better science, we began to provide anesthesia for those preterm babies, and, in fact, we saw that their outcomes improved.
However, as the '80's progressed, new information continued to come forward, and our day-to-day practice of pediatric anesthesia had to change. At this point in time, it became unconscionable for any of us to take a child to the operating room or do something painful without providing it an anesthetic. For us, the question was not, does the child feel pain, or if the child feels pain, the question was, how are we going to block the pain?
So I would say, I think this dialogue today is actually 25 years lagging behind our clinical practice.
Well, that was 20 years ago. If you came back with me to Savannah tonight and came to our neonatal intensive care unit, we would stand between the bed of a 23-week infant, a 26-week infant, and you would not need a congressional hearing to figure out whether that infant feels pain. We roll back the sheets or the blanket, and you would look to the facial expression, their response to the heel stick, you would understand that.
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Now we know that when Roe v. Wade was decided, 28 weeks was the time of viability. Today we look at 23, 24 weeks. So every single day we have a perfect window into the womb to look at how that child processes pain, and because of the work of Sunny and other researchers, we continue to change our bedside practice.
Our previously held assumptions about these tiny babies had to be set aside, and we began to understand the fight-or-flight hormone response, their heart rate response, their sympathetic response. We went so far as to invest in special beds and lighting and even sound detection to minimize anything that would be seen as stressful, even something as simple as a heel stick.
In the 1990's, many of our NIC units did not have any uniform approach to approaching pain in the NIC unit. Today they do. Intensive care units have a standardized approach. We monitor all the things that I just mentioned. We respect the pain. We respect the stress. We do everything we can to avoid it, and we treat it when present. Today, pain relief is an important step to generating a healthy outcome.
Well, with that knowledge explosion in the field of pain development in the fetus, as I mentioned, the world of anesthesia changed, and, you know, I guess I would use a phrase, the sound barrier, particularly in the area of partial-birth abortion, or the discussion around partial-birth abortion broke the sound barrier around this whole topic of fetal pain. It was in the mid-'90's when I was here and we were discussing that legislation and we began to talk about pain in the third trimester, but now we know that it is not just the third trimester, but it is as early as 20 weeks, and there is data that shows 16 weeks and even earlier, many of these infants feel pain and have negative outcomes from it.
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You know, as a mother I look at this whole topic, and I think about it every time I take my daughter to the doctor. Her first question to me is, ''Mommy, is this going to hurt?'' And as a mother I feel like it is my duty to find out that information and to do everything I can to keep her from a painful or stressful situation.
Well, that is what we are asking today. We are asking for legislation that allows that question to be asked by mothers, and for them to be given clear, scientific information that outlines that pain development. You know, we believe that to do less than that would not be giving good informed consent as a clinician.
I will stop right there.
Mr. CHABOT. Thank you very much, Doctor.
[The prepared statement of Dr. Wright follows:]
PREPARED STATEMENT OF JEAN A. WRIGHT
BACKGROUND
I am a physician who has specialized in the care and anesthesia of critically ill infants, newborns, children and adolescents my entire career. I now head a children's and women's hospital within a larger medical center in Savannah. I have testified before two Congressional subcommittees on this or a similarly related topic, and have testified on the same subject in several state legislative bodies. The opinions I render today are my own, and do not represent any group.
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I am trained in the specialties of Pediatrics and Anesthesia, and am Board Certified by both. In addition, I am board certified in Pediatric Critical Care Medicine, and similarly hold the Anesthesia special qualifications in Critical Care Medicine. I continue to practice medicine in addition to my administrative responsibilities.
HISTORICAL PERSPECTIVE
My own personal sojourn in medicine historically reflects the changes in this field of medicine, and the incorporation of new information into clinical practice. My experience and practice in this discipline over the past 25 years mirrors that of countless others who cared for the critically ill child. I entered the field of pediatric anesthesia and intensive care in the early 1980's. Twenty-five years ago, it would have been common practice to take a critically ill premature infant to the operating room for major abdominal surgery and provide little or no pain management. Our knowledge of pain and its importance in the overall outcome of the child was unknown, and not part of our clinical decision-making.
For many of the procedures, we felt the premature and newborn infants were simply ''too sick and too small'' for anesthesia and pain relief. We did not feel that their immature bodies could withstand an anesthetic along with their procedure. Little did we know that in our avoidance of anesthesia, we were in fact creating a more stressful and more harmful environment for these vulnerable patients. We often relied on neuromuscular blocking drugs to hold the infant motionless during the procedure. Their motionless body did not tell the internal story of what they were feeling and perceiving in regards to pain. Today, in hindsight, we now understand that the infant was often returned to the neonatal intensive care unit in a more debilitated state than when they left it pre-operatively. We recognized then, and better understand now that it took them days to stabilize, recover, and begin to gain weight, and return to their pre-operative state. And we saw many infants that never seemed to recover from the procedure.
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CHANGING THE PRACTICE OF PEDIATRIC ANESTHESIA
However, in the 1980's, new information began to surface, and in response to this new body of scientific knowledge, our clinical practices of pediatric anesthesia and intensive care had to change.
The practice of pediatric anesthesia for the premature and newborn infant began to incorporate the use of narcotics and other analgesics on a regular basis. Soon it became unacceptable to consider taking an infant to the operating room for major heart or abdominal surgery without recognizing the stress response this would generate in the infant, and developing an anesthetic plan that would safely block or blunt those responses. By the end of the 1980's, the work of Dr. Anand, Dr. Hickey, Dr. Ainsley-Green and others surfaced in a myriad of our most respected American and British Journals. Their elegant work, along with the works of others, demonstrated that this pain response in the infant was not an inconsequential byproduct of a surgical procedure that could be ignored at the anesthesiologist's whim or personal choosing. For us practicing in the field, it was not a question of ''if the premature or term infant felt pain'' . . . it was ''how do we block the pain to improve the child's outcome.'' For us the question became ''how,'' not ''if.''
EXTENSION TO CARE IN THE NEONATAL INTENSIVE CARE UNITS
That was twenty years ago. Today, if you walk with me in our neonatal intensive care unit, you will see the same concern exhibited for our tiniest of all infants. The concern about how to block pain, how to eliminate stress, how to improve survival, and how to minimize the complications that frequently accompany premature infants is on the forefront of the care-givers mind. Viability for the premature infant has long since passed the 28 week gestational age definition that existed when Roe v. Wade was decided. For some infants, viability has been pushed back to 23–24 weeks. And so many of our neonatal units now have infants of 23 weeks and older gestational ages.
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Because of the work of many researchers in the fields of pediatric anesthesia, their scientific inquiry led to a change in practice. Early in the 1990's, many neonatal units considered the infants too weak or sick for pain-relieving medications. Our previously held assumptions are replaced with first hand observations of these tiny patients, with monitoring of the hormones released from the neuro-humoral axis (our fight and flight hormones), and with a clearer understanding of the development of pain pathways in the fetus. We invest in expensive beds to eliminate noise and pain, and in a care plan that minimizes painful sticks and pokes. We now regard even the pain of a simple heel stick for a routine blood sample.
In the early 1990's many neonatal intensive care units did not have uniform approaches to minimizing painful events, or pre-treating infants prior to painful and stressful procedures. Today they do. We are so mindful of even the stress of noise and touch, that neonatal intensive care units monitor the sound level, and minimize the number of times an infant is handled, poked or stress, . . . all in the name of decreasing pain and stress, and improving clinical outcomes. We respect the pain and the stress, we do everything we can to avoid it, and we treat it when present.
Today, pain relief is an important step to generating a healthy outcome. Today with the survival of 23 and 24 week infants, we no longer speculate as to whether they feel pain. We understand it, try to avoid it, and treat it when appropriate.
THE DISCONNECT BETWEEN PAIN IN THE NEONATE AND PAIN IN THE FETUS
With the knowledge explosion in the field of pain development in the fetus, the world of pediatric anesthesia and neonatal intensive care changed. Why did this same information not change the world for the unborn? To regard pain in the unborn required that we consider pain during in utero surgical procedures, but also pain to the unborn during an abortion. Furthermore to recognize the unborn's ability to perceive pain would require that we disclose that information to the mother prior to the procedure as part of the informed consent. Perhaps, with that information at hand, the mother might change her position regarding an abortion for her unborn. Therefore the scientific information regarding pain in the unborn was not integrated with the dialogue around the procedures of abortion.
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In the mid 1990's the discussion around partial-birth abortion broke the sound barrier around fetal pain. A discourse followed around whether the infant felt pain, whether maternal anesthesia could or would treat the pain, and whether informed consent for the procedure should disclose the possibility of pain to the unborn. Discussions on partial birth abortion brought into focus the developmental realities of the infant in the 3rd trimester, and juxtaposed that stage of human development with its ex-uterine counterpart, the preterm infant. Further scientific discoveries over the past decade have only served to underscore the anatomy and physiology of the pain pathways in the unborn and preterm infants. Now several states have begun to wrestle with the legislative aspects of both protecting their most vulnerable subjects from pain, and from informing their mothers of its presence and its need for treatment.
THE ROLE OF INFORMED CONSENT
As a mother myself, every procedure I face with my own child is preceded by her first question, ''Mommy, will this hurt?'' It is my natural maternal response is to try to avoid all forms of pain and suffering for my child. As a parent I want to know about the possibility of pain, and my child (if old enough) wants to know as well. But for the child unable to speak, or unable to understand the upcoming flu shot or laceration repair, the parent stands in the gap gathering clinically relevant information, and exercising prevention and protection against harmful or painful situations. It is our question to ask, ''Will my child feel pain?''
Parents are entitled to this information for their children. They need it explained in a clear and meaningful way that they as laypeople can understand. This standard exists for children born; now we raise the standard and ask that it exist for those unborn. ''Will this surgery or procedure on my premature baby cause pain? What will be done to alleviate the pain and suffering?'' We should answer those questions as clearly for procedures concerning the unborn as the born.
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WHAT WILL WE TELL THEM?
Beginning as early as 6 weeks of development, tiny pain fibers pepper the face and oral mucosa. The spread of these unique fibers proceeds in a head to toe fashion until by the 20th week, they cover the entire body. Not only do these fibers exist, they do so with greater density per sq inch than in the adult.
These fibers will connect with the spinal cord, and then connect with fibers that ascend to the thalamus and cortex. By the 10–12th week, the cortex is developing, and by the 15th week, the fibers from below have penetrated into the cortex.
Studies at 16 weeks and beyond show hormonal responses to painful stimuli that exactly duplicate the responses that the infant and adult possess. The critical difference is that the unborn lacks the ability to modulate itself in response to this pain. Therefore, the responses of hormones to painful procedures show a 3–5 x surge in response. This ability to down-regulate the response in light of painful stimuli will not exist until the unborn child is nearly full term in its gestational age. Further studies demonstrated that the magnitude of pain response reflected the magnitude of the stimulus and blocking the pain receptors with narcotics, blocked the hormonal surge. By 19–20 weeks, EEG recordings are readily documented, and somatosensory evoked potentials (SSEP) are seen by 24 weeks.
After 20 weeks of gestation, an unborn child has all the prerequisite anatomy, physiology, hormones, neurotransmitters, and electrical current to ''close the loop'' and create the conditions needed to perceive pain. In a fashion similar to explaining the electrical wiring to a new house, we would explain that the circuit is complete from skin to brain and back. The hormones and EEGs and ultrasounds record the pain response, and our therapies with narcotics demonstrate our ability to adequately block them. Therefore, any procedure performed on an unborn child after 20 weeks should take this into consideration.
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''Can the unborn fetus feel pain at this stage of development,'' we would be asked.
''Is there something that can be given to alleviate the pain?''
And we would answer, ''Yes,'' to both.
WHY ISN'T TREATING THE MOTHER ENOUGH FOR THE CHILD?
Most obstetrical anesthetic care plans use spinal, caudal, epidural or other forms of nerve blocks to interrupt the cause of pain and the perception of pain. We refer to this as regional anesthesia. The sensory nerves that innervate the abdominal wall and the lower pelvic structures are anesthetized in the same manner that a tooth is numbed by a nerve block with Novocain at the dentist. The mother's specific nerves, or nerves that innervate the perineum, are blocked by these regional anesthetic techniques. While this serves as excellent anesthesia for the mother, it provides no anesthetic relief to the unborn child.
Advances in intra-uterine surgery have required more detailed thinking about pain management of the unborn during these operations. In essence, two anesthetics are planned. One for the mother and one for the unborn child. If an intravenous anesthetic is used, such as a narcotic, it must go through the mother's circulation, and then enter the fetus' circulation, and the reach the fetal brain, in order to achieve pain relief. Dosing via this route must be such to achieve a safe level of anesthetic in the unborn. Similarly, doses of narcotics may be given directly into the amniotic sac, or into the vein of fetus. Experience with premature infants shows us that the dose of narcotic is small, and can be given safely, and is inexpensive, and is effective in blocking pain and improving outcomes.
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CONCLUSION
The development of the perception of pain begins at the 6th week of life. By 20 weeks, and perhaps even earlier, all the essential components of anatomy, physiology, and neurobiology exist to transmit painful sensations from the skin to the spinal cord and to the brain.
Infants in the neonatal intensive care unit give us a clear picture into life in the womb for the unborn fetus age 23–40 week gestation. Our understanding of the presence of pain, and the need to clinically treat this pain in the premature infant leads us to understand the presence of pain, and the need to treat pain in the unborn fetus of the same gestational age.
Our conscience as clinicians requires us to apply the same standards of informed consent that we would to any other patient in a same or similar situation. We no longer can ignore the fact that maternal anesthesia treats the mother's pain perception during these procedures, but leaves the unborn with no pain protection.
Our knowledge of this field has changed our clinical practice and now the legislative issues must change as well.
Mr. CHABOT. Dr. Caplan, you are recognized for 5 minutes.
TESTIMONY OF DR. ARTHUR CAPLAN, DIRECTOR, CENTER FOR BIOETHICS, AND CHAIR, DEPARTMENT OF MEDICAL ETHICS, UNIVERSITY OF PENNSYLVANIA
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Mr. CAPLAN. Thank you, Mr. Chairman and Members of the Subcommittee, for the opportunity to testify before you in this legislation. I know you have the written testimony there, so I am going to narrow my remarks down to four subjects.
First, is there consensus on fetal pain? I am not an expert on fetal pain like some on the panel here, but I have access to Children's Hospital of Philadelphia, which is an institution that has many experts in fetal pain there. And so when this hearing came to my attention, I went over and asked them what they thought about fetal pain, when it begins, when is the age of onset, and it is clear to me that there is not a consensus.
Secondly, I want to say a word about risk and benefit as presented in the script that is in the legislation concerning risk to mothers of the administration of pain-relieving analgesics and anesthesia to the fetus.
Third, I am just going to say a word about is it a good idea to get use a script to get informed consent, which is perhaps of less interest to some on the Committee, but is of keen interest to me in terms of trying to make sure that all Americans get informed consent in research and therapy; and lastly, whether it is a good idea for Congress to come into this area with mandates about how to achieve certain social goals.
Firstly, as I said, I had an opportunity to go over to this hospital. It is full of all kinds of experts, and I basically just asked around to my colleagues, and I got answers back that were all over the place, from 20 weeks, somebody reported they thought perhaps younger. Other people said absolutely not until 24, 26 weeks; all kinds of comments about brain development, all kinds of ideas about what is meant by pain.
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I looked in the literature I would tell one of my students to do in pursuing informed consent, and as we have heard, there is a wide spectrum of opinion about when pain begins. The JAMA article that Dr. Anand reports about sets the level at 28 weeks based upon a thorough review in a leading medical journal. Other documents and reports from the United States and Britain said 26 weeks, 24 weeks; some say 20 weeks.
It doesn't matter to me in a sense whether a particular study is right or wrong or beyond critique. That is what scientists do. What matters to me is there is no clear-cut consensus out there. So to mandate a triggerpoint and say this is when it has to be done seems to me to not be consistent with what Congress ought to be doing about invoking the power of science to serve a social or an ethical goal even if it is an admirable or perceived as an important goal. I don't think the consensus is out there to support what is claimed in the legislation.
Secondly, on matters of risk/benefit, there is a lot to be said there. But let me narrow it down to one item: What is told to the mother about the risks that she faces if somebody tries to administer pain-relieving mechanisms to the fetus directly through her body. When this is done, it is usually in the context of fetal surgery.
Again, I have been involved in many review boards that have tried to assess the ethics of fetal surgery. They are tough because you are risking two lives. Normally the risks involved in fetal anesthesia in utero are acceptable because you are trying to save the fetus, you are trying to help the person have a very much wanted child, and mothers will take a lot of risk. But in context we are talking about here, the exact phrasing in the legislation, there may be risk in the administration of anesthesia to the mother, is not at all adequate to what is going on relative to direct administration of pain relief prior to abortion.
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So I would urge the Committee to take a close look there and ask the question, is that an adequate informed consent about risk to mother, and will women, in fact, be weighing the risk and benefits appropriately by talking about the other uses of fetal anesthesia which come from the fetal surgery setting, not from situations where someone is going to try and directly go to the fetus from the outside? That is going to be a pretty risky activity not adequately captured, I would suggest, in the legislation right now.
The third point I wanted to mention is just whether scripts make sense for informed consent. And I don't know of any situation in American health care where we give people scripts and say read them and get informed consent to research or therapy. When people do do that, we actually yell at them and say that isn't informed consent.
Informed consent is a process. Let me put it simply: Not every mother is the same. Not every mother is going to have the same health background. Not every fetus will be the same; some will have terrible genetic deformities, some are going to be hale and hearty. The situations are not well captured by a script, and if you try to achieve informed consent just by reading off a script, I would tell you that is not the standard of ethics that ought to prevail in the United States today in any setting.
So it seems to me the script idea is suspect if what we really want to do is get a good informed consent. And for the reasons I mentioned, the script that is there perhaps is inadequate.
Lastly, I think it is not a good idea for Congress to try and practice medicine. I understand the subject is one of grave concern to many people, but it seems to me physicians hold different views about this matter. What we have to do is encourage them and urge them to give information to their patients, to have those dialogues about what they deem important and appropriate to protect the health, welfare and comprehension of their patients. I don't know if that comes well from Congress.
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Mr. CHABOT. Thank you very much, Dr. Caplan.
[The prepared statement of Mr. Caplan follows:]
PREPARED STATEMENT OF ARTHUR L. CAPLAN
Thank you Mr. Chair and members of this Committee for the opportunity to testify before you on the proposed legislation which would require that women seeking abortions be informed about the pain to be experienced by their unborn child. My opinion is that this is not legislation that the House should enact. I will present a number of ethical issues that the committee may wish to consider as it examines this legislation.
I will organize my testimony as follows: first, I will address the presumptions behind the proposed legislation and the comment on what is known or in dispute about those presumptions, second, what informed consent requires in terms of risk and benefit disclosure, third, I will offer my opinion as an expert on the ethics of informed consent on the advisability of enacting legislation which mandates the content of a script be read to patients by their physicians, and, lastly, I will offer some comments on the advisability of Congress inserting itself into the practice of medicine in the United States and the morality of intruding into the doctor/patient relationship.
FETAL PAIN
The proposed legislation before the House contends that unborn ''children'' have the physical structures necessary to experience pain at the age of twenty weeks of development. There is also a contention that giving anesthesia or analgesics to a pregnant woman does not diminish the pain capacity of an unborn fetus. And it maintains that medical science is capable of reducing fetal pain by delivering anesthesia or pain-reducing drugs directly to the ''pain capable unborn child.''
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These are the findings used to them justify an unprecedented requirement in the history of American medicine—the provision by telephone or in person of a required statement by a physician or the physician's agent to offer the option of the use of anesthesia or pain-reducing drugs ''to the pain capable unborn child.''
The question this committee must carefully consider is whether there is as a matter of empirical fact consensus about when a fetus is capable of feeling pain. If the rationale for mandating disclosure about techniques to minimize fetal pain prior to abortion rests on science and not the whim or presumption (and I use those terms intentionally) of non-scientists and non-physicians then there must be clear consensus on the part of the medical profession that at twenty weeks a fetus is pain-capable.
This is an enormous body of evidence which shows that the presumption of medical consensus does not exist about the question of when a fetus becomes pain-capable.
A variety of groups and commissions in the United Kingdom and researchers in the United States and other nations have, in recent years, examined the question of when a fetus can feel pain. None of them has reached a consensus that is reflected in the proposed legislation.
For example, five years ago the Commission of Inquiry into Fetal Sentience in the House of Lords in England looked at the question of when can a fetus feel pain. They found that a fetus may be able to sense some ''form of pain sensation or suffering'' when the cortex has begun forming connections with the nerves that transmit pain signals.
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This occurs ''after 23 weeks of growth.''
''By 24 weeks after conception the brain is sufficiently developed to process signals received via the thalamus in the cortex.'' The noted that, ''While the capacity for an experience of pain comparable to that in a newborn baby is certainly present by 24 weeks after conception, there are conflicting views about the sensations experienced in the earlier stages of development.''
A year later another distinguished group of physicians from the Royal College of Obstetricians and Gynecologists in the United Kingdom examined the same issue. The panel consisted of experts in fetal development, law and bioethics.
The group determined that a fetus can only feel pain after nerve connections became established between two parts of its brain: the cortex and the thalamus. This happens about 26 weeks from conception. Professor Maria Fitzgerald of University College London, author of the working group's report, said that ''little sensory input'' reaches the brain of the developing fetus before 26 weeks. ''Therefore reactions to noxious stimuli cannot be interpreted as feeling or perceiving pain.'' W.G Derbyshire writing in the Bulletin of the American Pain Society in August, 2003 basically concurred with the view that the fetus becomes pain capable at 26 weeks.
This year a meta-study—a review of existing medical studies into fetal pain—was published in the Journal of the American Medical Association (JAMA). The paper concluded that in reviewing all recent published studies that a fetus's neurological pathways that allow for the ''conscious perception of pain'' do not function until after 28 weeks' gestation.
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It is possible to criticize each of these studies and reports. And there are many more such reports and studies with different conclusions. But that is precisely the point the Congress must carefully reflect upon before enacting any legislation pertaining to fetal pain.
There is no consensus among the medical and scientific experts about precisely when a fetus becomes pain-capable. Some put the point at 28 weeks. Others say 26 or 24 and still others younger still. But, without a clear consensus legislation mandating that a health provider or physician represent something as a fact which is not known to be true or agreed upon by the majority of medical and scientific experts as valid would not only be poor public policy it would set a terrible precedent for other topics where Congress might choose to mandate disclosures about ''facts'' for political or even ethical reasons which have no foundation in science or medicine.
Mandating the provision of information as factual or as the standard of care or as a matter of consensus among experts when the information is none of these could open the door to an enormous slippery slope regarding what those seeking health care are told. In order to achieve political ends even well-intended ends it is exceedingly dangerous as history shows to try and bend science to serve political goals.
CONSENT, RISK AND BENEFIT
If Congress decides to mandate the provision of information to women about fetal pain prior to abortion then it will have to carefully consider the content of what is being mandated and whether it adequately reflects the standards of full disclosure of risk and benefit as well as the provision of information about all options and alternatives.
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In creating a standard of disclosure about fetal pain and the use of anesthesia it will be necessary to disclose whether or not existing techniques are known to relieve fetal pain, at what age of fetal development and what evidence exists to support such claims.
In notifying women that anesthesia administered to them will not provide pain relief to their fetus again it will be necessary to state with more clarity then appears in this legislation why that is held to be so as a matter of medical consensus and what the probability is of the statement being wrong. Informed consent will also require a more careful and precise delineation of the risks of anesthesia to the woman if it is directly administered to the fetus. The risk of fetal anesthesia is usually viewed as trivial since they are usually encountered during efforts to use surgery to repair a life-threatening risk to the fetus. They become far less trivial when placed in the context in which death to the mother becomes a possibility with uncertain benefit to the fetus. And some discussion will have to be had about the risks to the woman's health of continuing various stages of a pregnancy versus terminating them depending upon her own health and medical condition.
None of these elements of risk and benefit appear in the mandated information to be disclosed by the proposed legislation. I doubt whether there are many IRBs in the nation which would approve the content of the disclosure as adequate to the standards of informed consent that have come to be expected for new, innovative and untested procedures in medicine.
MANDATING THE CONTENT OF INFORMED CONSENT
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One of the most troubling aspects of the proposed legislation is the concept of the government requiring a mandated script or formula be used to secure informed consent in a doctor-patient relationship or health care provider-patient relationship. I know of no other area of health care where Congress or a state government has mandated the content of informed consent.
It is hard to justify a fixed script since every patient is different, not all pregnancies are alike, not all fetuses have the same capacities at the same age of development and not all women face the same set of risks or have the same ability to understand and process information. Informed consent is not a formula—it is an individualized communication between provider and patient. To mandate that one size will fit all when it comes to the issue of fetal pain and what might be done about it is to fly in the face of decades of medical experience about informed consent as well as numerous court cases in which judges have found that simply reading a piece of paper or running through a standard template does not satisfy the requirements of informed consent.
INTERFERENCE WITH THE PRACTICE OF MEDICINE AND THE DOCTOR/PATIENT RELATIONSHIP
It is my opinion that mandating the specific nature of what must be communicated to a woman considering an abortion or any other medical procedure is an unwise interference with the practice of medicine by Congress. One may well wish to discourage women from choosing abortions but forcing providers to read claims about fetal pain is showing no respect for the ability of the medical profession to present information about pregnancy, abortion and fetal pain to women. Moreover, since different physicians hold different views about fetal pain and about the ability to control that pain and since different providers will have different skills when it comes to the safe administration of anesthetic agents or anesthesia to women or fetuses it is overreaching for Congress to insist on precisely what each provider must say to each woman prior to an abortion or any other medical procedure.
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In summary there are many issues this committee and Congress must consider before moving forward with the proposed legislation on Pain of the Unborn. There is no consensus among experts about when a fetus becomes pain capable. There is no consensus about the efficacy of existing agents to relief pain in a fetus. There is no single standard that can be set as to what the risks are of attempting to administer pain relief directly to a fetus. This makes it difficult for Congress to claim a sufficient foundation for claims about the pain capabilities of the fetus at various stage of development.
It is also difficult for Congress to mandate the content of informed consent without reducing consent to the provision of a ''boilerplate'' set of facts—something which we have been advising doctors not to do in the name of informed consent for many decades.
And even with the best of motives intruding into the doctor-patient relationship when the facts are unclear and the risk unknown opens the door to slippery slope with enormous ramifications for the future practice of medicine. This is a door that ought be opened with the greatest of care and caution if at all.
Mr. CHABOT. Professor Collett, you are recognized for 5 minutes.
TESTIMONY OF TERESA S. COLLETT, PROFESSOR OF LAW, UNIVERSITY OF ST. THOMAS SCHOOL OF LAW
Ms. COLLETT. Thank you, Mr. Chairman, Mr. Nadler and Members of the Committee.
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I am the author of one of only two existing Law Review articles on this subject. It was published in Pepperdine Law Review in 2003, and I wrote on this topic because, in fact, it was a topic that I anticipated various State legislatures and, in fact, Congress legislating on.
When you look at the most recent abortion textbook for medical schools, edited by Maureen Paul, when she has a chapter on counseling of abortion patients, they speak specifically about the concern that abortion patients express about whether or not the fetus will feel pain during the procedure. And the advice is given in that particular chapter by Ms. Baker that in order to respond to this concern on the part of women seeking abortions, that women should be given information about fetal pain.
In doing research for that particular article, what I found was, in fact, in the United Kingdom, the Royal College of Obstetricians and Gynecologists at the direction of Parliament did an extensive study of this topic under the direction of Dr. Glover, who describes herself as a pro-choice physician, and determined that they should adopt a protocol that requires the use of fetal anesthetic or feticide through the use of potassium chloride or digitalis or some other chemical directly to the heart of the fetus prior to performance of abortion or fetal anesthetic prior to any fetal surgery at age 24 weeks. That protocol then in 1997 was brought into question at the direction of the British Medical Research Group, and they are now discussing lowering it to age 20 weeks.
In fact, the British Medical Association directs that even if there is no incontrovertible evidence, the consensus that Dr. Caplan would demand, that fetuses feel pain, the use of pain relief, when carrying out invasive procedures, may help relieve the anxiety of parents and of health professionals. That last clause, in fact, is what motivated the province of Alberta, our neighbors to the north, to adopt their professional protocol that requires the use of feticide for any abortions at age 20 weeks prior to the performance of an abortion.
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Mr. NADLER. Use of what did you say?
Ms. COLLETT. Feticide, the use of digitalis or potassium chloride directly to the heart of the fetus prior to the abortion. The reason for that, Representative Nadler, is because of the techniques of abortion that are used most commonly at that point or beyond that are either dismemberment abortion or the use of the D&E or the D&X abortion, which I am sure Members of this Committee are familiar with, or saline abortions on rare occasions. They are not used very often anymore because of the other two procedures being preferred, according to various CDC statistics. Because of the pain that we may anticipate with either of those procedures, Alberta requires that physicians induce the death of the fetus prior to that. Because of this concern on the part of women, informed consent would require that they be informed.
The final piece of evidence I would bring to the attention of this Committee comes not from foreign jurisdictions, but, interestingly enough, from the most recent trial in California on the Federal partial-birth abortion ban where Dr. Katharine Sheehan testified as an expert witness on behalf of the plaintiffs in challenging the ban, where she said that as medical director for the Planned Parenthood San Diego clinic, that it was the practice of that clinic to always offer to engage either in feticide or to offer fetal anesthetic for any abortion after—at the period of gestation of 22 weeks or more, and that she had never had a patient decline it.
This is an issue that women who chose, because of perhaps tragic circumstances, to go forward with abortion are concerned about.
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Frankly, of all of the many issues related to abortion, if there is one that we can find common ground on, surely it is the issue that where necessity, as the woman perceives it, drives her to this, there should be no unnecessary suffering on the part of the unborn, and that women should have the opportunity to know that there is at least a respectable body of research that suggests that that possibility exists.
Thank you.
Mr. CHABOT. Thank you, Professor Collett.
[The prepared statement of Ms. Collett follows:]
PREPARED STATEMENT OF TERESA STANTON COLLETT
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Mr. CHABOT. I now recognize myself for 5 minutes for the purpose of asking questions.
I would just note that we are not talking about an insignificant number of abortions after 20 weeks. Each year in this country, I understand there's—depending on the figures, it is somewhere up to 20,000 or so of these types of abortions that take place after 20 weeks.
Professor Collett, let me begin with you if I could, and I will get to the heart of the matter, cut to the chase so to speak.
In your opinion, are informed consent provisions requiring that information on fetal pain and anesthesia be given to pregnant women considering an abortion consistent with the Supreme Court's abortion jurisprudence?
Ms. COLLETT. Yes. Casey was quite clear about that. You read a portion of the Casey plurality opinion, and they go beyond that to give the example of, we think it would be constitutional for the State to require in order for there to be informed consent to a kidney transplant operation that the recipient be supplied with information about the risks to the donor as well as the risks to himself or herself. It is quite clear that simply an informational requirement as has been proposed would pass constitutional muster.
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Mr. CHABOT. Thank you.
Dr. Anand, let me turn to you next if I can. In your opinion, at what point does an unborn child likely experience pain, and what evidence best supports that opinion?
Dr. ANAND. Thank you. This is a question that is hotly debated, as Dr. Caplan pointed out, and it is not very clear from a summary of the evidence as it really does not meet the criterion of something that can be turned on or turned off.
The development is a slow and continuous process, and different centers of the brain participate in sensory perception at different stages, so it is very unclear and hard to pinpoint as to exactly when. Yesterday the fetus did not feel pain; today the fetus does feel pain. And it is unlikely that that happens.
What possibly occurs is a gradual increase in the ability of the fetus to recognize some stimuli which may cross a certain threshold of nociception and for those stimuli to be transduced at some points.
My opinion is, based on evidence suggesting that the types of stimulation that will occur during abortion procedures, very likely most fetuses at 20 weeks after conception will be able to perceive that as painful, unpleasant, noxious stimulation.
Mr. CHABOT. Thank you. And is it your opinion that the pain perceived by the unborn is possibly more intense than that perceived by term newborns or older children?
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Dr. ANAND. No. There is—that is not my opinion. And I really don't have any data to suggest that that could be true, or the other way. There is——
Mr. CHABOT. Have you heard that opinion expressed by others in your field?
Dr. ANAND. There has been some data to suggest that in preterm neonates, there is a lower threshold to pain than in full-term neonates and in older children or adults. Whether we can extend that back into gestation is not known at this point.
Mr. CHABOT. Thank you.
Dr. Wright, let me ask you, could you please describe some of the responses to noxious or offensive or unpleasant stimuli that you have witnessed in preterm infants?
Dr. WRIGHT. Sure. You know, we know that these pain receptors are unique. When you look at them under a microscope, they don't look like any other kind of cell, and they start on the face, and as doctor Anand said——
Mr. NADLER. Is that true in all stages or only for neonates?
Dr. WRIGHT. Excuse me, sir?
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Mr. NADLER. Were you making that as a general statement or only for neonates?
Dr. WRIGHT. I haven't finished the sentence, sir, so I am not quite sure what you are interrupting.
Mr. NADLER. When you said these pain receptors are unique, they don't look like any other kind of cell.
Dr. WRIGHT. Right. They start at 6 weeks of gestation. They cover the entire face even more densely per square inch than adults and cover the entire body. So by the time this baby is 20 weeks of gestation, there are these pain receptors over the entire body, the entire mucosa, the exact same kind that we have as full-term babies and we have as adults. Is that what you are asking?
And because that pain fiber sits there, it connects with the spinal cord and, most importantly, sends messages, sends impulses to the bran to those higher levels and back down. When we put on a clamp on a toe, when we do a heel stick, that is probably the most common thing we do in the neonatal intensive care unit, take a lancet, hit the heel for blood, squeeze that little heel and put it on a piece of blotter paper and insert it in a test tube, those children will withdraw. That is not just a knee-jerk reflex. That's an integrated, full arc up through the brain and back. They grimace, they pull back.
Even the studies of children in utero when they had repeated liver samples or transfusions done either through their liver or through their umbilical cord, those children positioned themselves to avoid noxious stimuli. Dr. Anand used a fancy word, nociception. We would say in Savannah just painful or obnoxious stimuli. They reposition themselves that way.
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So to a lay person standing next to a bed, there is no question that that is pain. It is not a hiccup, it is not a reflex. You know, we recognize it for what it is.
Mr. CHABOT. Thank you very much. My time has expired.
The gentleman from New York is recognized for his time as well.
Mr. NADLER. Dr. Anand, do you agree that there is still no consensus within the field on the question of when the fetus starts perceiving pain?
Dr. Anand. Yes, I did.
Mr. NADLER. Thank you.
Also, Dr. Anand and I think Dr. Caplan, while some States have pursued the script approach, the Federal Government so far has not. Do you think we ought to require doctors to read scripts written by Congress on this or other issues?
Let me just broaden that a bit. I have considerable sympathy for a lot of the ideas in this bill and in what I am hearing. The problem I have is Congress directing a specific script which says Congress makes this medical finding. Would you think that that is a good approach, or might it be a better approach to simply say that doctors shall inform the patient or the patient—the prospective mother of what the current state of medical knowledge is in his or her opinion and tell her pros and cons of using anesthesia?
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Dr. Anand?
Dr. ANAND. I agree with you. I think there is consensus in the medical and scientific research community that there is a—there is no possibility of pain perception in the first trimester. There is uncertainty in the second trimester. There is no discussion in the third trimester. There is consensus that pain perception is fully developed and——
Mr. NADLER. I am asking you about the script in particular.
Dr. ANAND. With regard to a script, I agree that each medical encounter has specific factors that determine the way in which an interaction occurs between the health care professional and the patient, and so having a script, I think, will be counterproductive in that situation.
I think, however, the health care professional must have this professional responsibility to provide the information that is available at that time.
Mr. NADLER. So a bill that simply said the medical profession should recognize—well, it should exercise its normal responsibility would be preferable?
Dr. ANAND. Yes.
Mr. NADLER. Thank you.
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Dr. Caplan.
Dr. CAPLAN. Well, I think the use of a script to achieve informed consent is a mistake, and I think it is a mistake to have Congress do it.
I think that the script that is in the bill is a clear example of this. It asserts more consensus than is true about fetal pain. It doesn't allow the nuance of talking to different women with different backgrounds, different educational levels, and different medical situations, different health situations. It won't be equivalent risk to give fetal anesthesia to a woman who has diabetes and a bunch of other complications and high blood pressure and 40 years old and as it would to somebody who is 22 and very healthy. Using scripts is not the way to achieve informed consent in terms of the nuance of what has to happen in medical care.
Last comment I would make is it seems to me that what we want to do is encourage honest discussion, open discussion about fetal pain capability, about options to control it, but the way to do that is to ask Government agencies to sponsor workshops, to achieve consensus panels, to hold the kinds of retreats and conferences that I go to a lot where people are educated and informed about this.
I don't see it done well by mandating it out of a bill that is going to be one size fits all, and that is not the world in which medicine is practiced.
Mr. NADLER. Well, you are describing how science and medicine normally works. Do you see a useful role for any legislation in this field, a bill that said that doctors should discuss this with patients, or is that necessary at all?
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Dr. CAPLAN. I don't think it is necessary at all. I think what you do is encourage physician education, physician training through outlets like the National Institutes of Health.
Mr. NADLER. Let me ask Dr. Anand the same question.
Dr. ANAND. I think there is—I agree with Dr. Caplan that informed consent is a process, that the interaction between the physician and the patient may occur at one time and may occur repeatedly until the procedure is performed.
So I think medical professionals should be encouraged to develop——
Mr. NADLER. But my question is Dr. Caplan described a process of holding all kinds of colloquiums on training medical professionals as to what their ethical duties are, in telling you about whatever the latest findings on pain are, and the latest findings on the advantages and risks of anesthesia and so forth. Granted that we should certainly do that. Do you see that any legislation is necessary or helpful in that, or is that sufficient?
Mr. CHABOT. The gentleman's time has expired, but you can answer the question.
Dr. ANAND. I feel that practitioners who are using this information should get—should be encouraged to remain up to date regarding this information. And in that sense, some type of continuing medical education should be required; should be required maybe not by law, but by professional standards.
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Mr. NADLER. I ask unanimous consent for 1 additional minute.
Mr. CHABOT. Without objection, a half minute.
Mr. NADLER. Thank you.
So do you think a good approach would simply be legislation mandating that kind of continuing medical education on that subject?
Dr. ANAND. I don't think legislation would be the answer. I think there are many other avenues that can be followed in order to encourage research in this area and to demonstrate knowledge in this area.
Mr. NADLER. Thank you very much.
Mr. CHABOT. Gentleman's time has expired.
The gentleman from Arizona Mr. Franks is recognized for 5 minutes.
Mr. FRANKS. Well, thank you, Mr. Chairman.
Mr. Chairman, I have to suggest that I have I am a little troubled by just a lot of the discussion here. Dr. Wright has answered a lot of the questions that I wanted to ask, and I think the thing that has troubled me here is that we have engaged in this pseudo-intellectual debate about whether a child at 20 weeks feels pain. And yet Dr. Wright has testified that a preemie at 20 weeks, when their heel is stuck or some noxious stimuli that even a 10-year-old could suggest would cause the child to feel pain, that the child pulls away. I have seen children in neonatal units cry when their blood is taken.
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And I guess I am really concerned about where our humanity is going here, Mr. Chairman, because there is so many anecdotal things that I could point to that really just concern me, but, you know, if a lot of us saw a little baby bird with a broken wing flopping around, we wouldn't engage in this intellectual debate of whether it is hurting or not. There would be something in our humanity that would call upon us to respond. And to me that is the greatest challenge we face here.
I know that for a lot of people on this side of the pro-abortion perspective that this whole discussion of pain for the unborn child is a delicate, uncomfortable one because it flies in the face of the position that they hold. And I understand the discomfort with that. But if all we really cared about was just being comfortable about the situation, we wouldn't be having this debate at all.
I am reminded of a situation that occurred when Dr. Abu Hyatt, Manhattan abortionist, performed a late-term abortion, and in the midst of it he had to suspend it and sent the mother home when she was still in a quasi-stupor, and the baby was born. But the baby was born without the child's arm. And at some point, the child must have asked that mother—the child lived and grew up, and the mother had to face a question from the child at some point, where is my arm?
And I think sometimes we overlook the fact that when we help mothers understand the reality here, we save them great pain in the long run many times, because I think that there are a lot of things that time tempers, that we know that we maybe had done something that we didn't want to. But to see a mother learn that her child felt pain in this circumstance has got to be an inconsolable situation, and my greatest fear—we have had people say, well, Congress shouldn't be involved here, they shouldn't be playing doctor, shouldn't be playing medicine. There was a time when medicine wouldn't have been involved in this discussion and a time when Congress wouldn't have to be involved in this kind of situation.
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Sometimes the obvious things we can see with our own eyes. Sometimes the clarity that a 10-year-old possesses escapes those of us that are erudite in the great policymakers of this country.
There is nothing that frightens me more for our humanity than somehow many could go to the end of it and looking back and realizing that our contribution to it was being willing to stand by and watch it desecrated before our very eyes.
So, Mr. Chairman, I really have a hard time adding much more to that, other than to suggest that we need to back up here a little bit before the last vestige of our humanity is distinguished and just look at where we really are, because if there is anything that is true about this life, it is that we are all mortal. And at some point, we have to ask ourselves what we have done for those around us.
I thank the panel, and I thank the Chairman for indulging me and just kind of, just a concern that I have about where this debate really is.
Thank you, Mr. Chairman.
Mr. CHABOT. Thank you very much.
The gentleman from Virginia is recognized for 5 minutes.
Mr. SCOTT. Thank you.
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We have heard from two witnesses; Dr. Anand and Dr. Caplan have raised questions whether a script is the most effective way to communicate, or whether a—just a description taken into consideration, everything, all of the factors involved.
Professor Collett, from your clinical, medical background, can you explain, can you tell us whether you think the script developed by Congress is more effective than an explanation from a medical background, getting guidance from the medical organizations?
Ms. COLLETT. I would challenge the characterization of Dr. Caplan of the bill. To begin with, if you look at section II(a)2, it's quite clear that after——
Mr. NADLER. Where are you?
Ms. COLLETT. I am sorry, I have an e-mail printed out, Congressman Nadler.
Mr. SCOTT. Page 11, line 24.
Ms. COLLETT. Thank you, Congressman Scott. It's quite clear that after a presentation of the statement, it is required that the physician, if that is the person who is providing this statement, it can also be an agent of the physician, which, in fact, it appears from the practice of most clinics as recorded by Guttmacher Institute and in the various surveys they do, after making this statement required under clause 1, the abortion provider may provide the woman involved with his or her best medical judgment on the risks of administering such anesthesia or analgesic if any and the costs associated therewith. Because we have at least four States in the Union that do not require abortions to be done by physicians. I think the script in fact is a very important fitting. For example——
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Mr. SCOTT. Just from your clinical background, you think the script is an effective way to communicate with the patient?
Ms. COLLETT. I believe in this particular subspecialty, Mr. Scott, because we have non-physicians engaging in the practice of abortion, a script is an important protection.
Mr. SCOTT. Dr. Wright, do you think a script is an effective way to communicate with patients?
Dr. WRIGHT. Well, I think it is certainly a tool, especially when we are in an area where information has not been given. We the people look to the Government to protect us and to stand up on our behalf. If women have not been given this information or have not been given it in a way that they can understand, a script at least makes sure that the same information is given to every patient.
Mr. SCOTT. Well, let me ask another question. Based on medical consensus, should anesthesia be administered or not, and at what gestational age?
Dr. WRIGHT. Based on——
Mr. SCOTT. Based on medical consensus. I mean, we are up here as politicians. We are not just receiving evidence. Is there medical consensus as to whether anesthesia should be administered or not?
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Dr. WRIGHT. All right. Let's start with the baby at 23 weeks, it pops out today and is on the outside. From then on in development, there is consensus. We provide anesthesia, period. No debate, no if, ands or buts.
Mr. SCOTT. Okay.
Dr. WRIGHT. For the baby younger than that, if it is on the inside, if it is fetal surgery, there are two anesthetics planned, one for the mom and one for the baby, because if you don't protect that baby from that stress and that pain, that baby will not survive, not only that procedure, but thrive inside.
Mr. SCOTT. Well, is there a clear consensus?
Dr. WRIGHT. Sure.
Mr. SCOTT. Does everybody agree with that? There's a clear consensus that, at 23 weeks, fetal anesthesia ought to be administered?
No, there is not. Dr. Caplan.
Mr. CAPLAN. After reading the literature, no.
Mr. SCOTT. There is not a consensus, no.
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Is there a consensus, Dr. Anand?
Dr. ANAND. There is a consensus. All the fetal surgical procedures that are done today at 20 weeks or later require anesthetic.
Mr. SCOTT. We are talking about abortions.
Dr. ANAND. Forgive me. I thought Dr. Wright had mentioned, given two examples, one for fetal surgery and the one for preterm neonatal surgery.
Dr. WRIGHT. Mr. Scott, there's not a consensus about giving anesthesia for abortion. That is why we are here, because no one wants to recognize that a baby undergoing an abortion feels pain.
Mr. SCOTT. So your testimony is that there is no consensus in the medical community as to what to do? I think Dr. Caplan has pointed out that, depending on the condition of the patient and various other risk factors, it may be a good thing to do; it may not.
Dr. WRIGHT. I would say to you, the medical community swims in two different ponds on this issue. There are those of us who practice fetal anesthesia, neonatal anesthesia. And there are abortionists. There is very little, if any, overlap. So to expect consensus out of those two camps is an irrational statement.
Mr. CHABOT. The gentleman's time has expired.
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I would just note, there is not much consensus relative to whether or not we ought to allow abortion in the country or not either, so——
Mr. SCOTT. I think, Mr. Chairman, with all due respect, here we have a bill that will prescribe a message to a patient. Presumably the message is going to suggest some action, and there's no consensus as to what the patient ought to do with the information? Should they have fetal anesthesia or not?
Mr. CHABOT. I think the argument is that they should be provided the information. They can then do with that information what they deem appropriate.
Mr. SCOTT. Well, it's——
Dr. WRIGHT. May I add one more comment. Congress did make some decisions about informed consent. The lawyer can answer it better than me, but it's around health care privacy and protection. Congress came up with that language. We the doctors didn't.
You prescribed it for us, and we give it to every patient the same way. So this is not the only time that informed consent has ever been prescribed by Congress.
Ms. COLLETT. What we were talking about prior to the hearing is the Patient Self-Determination Act, which is key to the Federal Medicare and Medicaid funds, which is not individual physicians.
Mr. NADLER. But that, if I may, that refers to legal rights not to medical status;correct? In other words——
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Ms. COLLETT. I understand.
Mr. NADLER. —the script that Congress provides, correct me if I am wrong there, says, this is your legal right; this is what the law says.Is that correct?
Ms. COLLETT. Actually, at the time it was passed, Congressman, there were several States that didn't have the documents that Congress wanted them to have.
Mr. NADLER. But as far as the legal system, not with the medical status; is that correct?
Mr. SCOTT. Well, if the gentleman would yield—or medical procedure.
Ms. COLLETT. It is about withdrawing or continuing life-sustaining care. So that distinction, I would argue, Congressman Scott, having been a lawyer that was in practice at the time it came down and advising a hospital, having to draft some documents for those hospitals, I think it affected the medical practice of my clients at that point in time. There were, in fact, scripts that we had to comply with. But I think more the concern was how we responded to it.
Mr. SCOTT. Mr. Chairman, could I ask unanimous consent for an additional minute?
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Mr. CHABOT. Without objection.
Mr. NADLER. Would the gentleman yield for Dr. Caplan to answer the question. He is obviously chomping at the bit.
Mr. SCOTT. Yes. Let me ask a question, then he can give the answer as part of the answer. The script includes statements like, the Congress of the United States has determined that, at this stage of development, an unborn child has physical structures necessary and whatnot. Is there any value to what Congress thinks about the issue? Wouldn't the patient be more interested in what the American Medical Association thinks about the issue?
Mr. CAPLAN. Well, I would answer that and say the following: I was getting agitated because I actually was in front of Senator Danforth for the Patient Self-Determination Act when it was legislated, as a witness, thereby dating myself as being more ancient than anybody ever should be. But at the time, there were recommendations about what people needed to know to control their care in terms of the legal rights.
But that is not the same as giving a script about what must be told to a person in terms of informed consent in their clinical care. So to tie back to your question, what I do believe—and I do respect Mr. Franks and Mr. Chabot's points about what people need to know in talking about respect for life—is if you want to educate physicians or nonphysicians to really do an educational job, to do what informed consent requires, telling them to read a script is not the vehicle. They won't understand it, some of them, the people reading it, so to speak. They are not up on all the literature. They won't even have all the evidence we have had in the room today. You have got to have this done as education. You have got to have it done as part of training. You have to put it in the residency programs. You want the professional societies to adopt it, and you want the Federal Government to encourage the proliferation of this information as it does in many areas, whether it is—I won't go into them—but it often encourages whether it is protection against getting the flu or whatever that these messages go out into the health professions so that people can talk to their providers.
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Last point, not every case is the same. The script is not reflective of that fact. You couldn't write it that way. When you have a baby born without a brain and it is an anencephalic baby, whether you are going to say it can feel pain or not and someone is getting an abortion for that reason is not the same as someone coming in for a different reason. What I worry about with the script is not that you can't answer questions afterwards; is that the script as it is written now and Congress is going to produce it is not going to be effective and not the way that we want information to come out between doctor and patient or health care provider and patient.
Mr. CHABOT. The gentleman's time has expired.
Did any of the other witnesses want to address or answer the question? If not, okay.
I want to thank the panel for their testimony this afternoon. This is obviously a controversial issue. Anything that touches on abortion always is. But you have helped shed light on this, and it's, I think, been very helpful.
If there's no further business to come before the Committee, we are adjourned. Thank you.
A P P E N D I X
Material Submitted for the Hearing Record
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APPENDIX TO THE PREPARED STATEMENT OF TERESA S. COLLETT, PROFESSOR OF LAW, UNIVERSITY OF ST. THOMAS SCHOOL OF LAW: FETAL PAIN LEGISLATION: IS IT VIABLE? Pepperdine Law Review. Vol. 30:161, 2003
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APPENDIX TO THE PREPARED STATEMENT OF TERESA S. COLLETT, PROFESSOR OF LAW, UNIVERSITY OF ST. THOMAS SCHOOL OF LAW: THE SCIENCE, LAW, AND POLITICS OF FETAL PAIN LEGISLATION. Harvard Law Review. Vol. 115:2010 2002
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PREPARED STATEMENT OF THE AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS
The American College of Obstetricians and Gynecologists (ACOG) represents 49,000 physicians and partners in women's health, who care for and treat women of all ages. As physicians dedicated to improving women's health care, ACOG opposes legislation that is not based on good science, legislates how physicians should care for their patients, and penalizes physicians for legal, medically-sound patient care.
As a result, ACOG strongly opposes HR 356, the ''Unborn Child Pain Awareness Act of 2005.'' This legislation would require doctors to read a government-mandated script informing the patient that the fetus might feel pain, offer or provide the patient anesthesia for the fetus, or give the patient a government prepared brochure on fetal pain. It would also impose civil sanctions and medical license revocations on a physician for failure to read such a script.
FETAL PAIN
ACOG, in consultation with physicians who are experts in fetal anesthesia and fetal surgery, knows of no legitimate scientific data or information that supports the statement that a fetus experiences pain at 20 weeks gestation. We do not know when, or if, fetuses begin feeling pain since the physical structures needed to feel pain form and are put into use gradually as fetuses develop.
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We know that the cerebellum attains its final configuration in the seventh month and that myelinization (or covering) of the spinal cord and the brain begins between the 20th and 40th weeks of pregnancy. These, as well as other neurological developments, including neurotransmitted hormones, would have to be in place for the fetus to perceive pain. Our knowledge is limited to animal studies that show that these hormones are developed only in the last third of gestation.
Balancing maternal and fetal risks may be different based on individual circumstances or indications for the procedure, but maternal safety must be considered when administering anesthesia to a pregnant woman. The higher dose or amount of anesthesia given to women who are undergoing fetal surgery puts the mother at greater risk. Furthermore, at this time, there is no way to measure the dosage of anesthetic agents delivered to the fetus and no way to measure the effects of these agents on the fetus.
GOVERNMENT INTERFERENCE WITH INFORMED CONSENT
HR 356 interferes with the doctrine of informed consent and deprives patients of their physicians' best judgments. Under threat of civil penalties or license revocation, this legislation would compel physicians to give women information about fetal pain that is contrary to medical knowledge.
Requiring a physician to read a government-mandated script that is not supported by scientific information violates the established doctrine of medical informed consent. Good medical practice demands that a patient and physician decide together on treatment based on the specific needs of each patient. Physicians have a legal, professional, and ethical obligation to share with their patients all relevant information about available health care options and to respect their patients' decisions. State laws, as well as established medical standards, ensure that women are provided with accurate and unbiased information about their health care options and give their informed consent for any procedure, including abortion.
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ACOG believes the government should not put obstacles, including inaccurate medical information, between a woman and her legal health care options.
CIVIL PENALTIES AND LOSS OF LICENSE
ACOG strongly opposes civil and loss of license penalties, against doctors who provide legal care based on the needs of their patients. Obstetrician-gynecologists cannot offer adequate or complete care when they fear they will be penalized for making decisions in the best interest of their patients.
SUMMARY
ACOG strongly opposes HR 356, the ''Unborn Child Pain Awareness Act of 2005.'' HR 356 requires medically inaccurate informed consent mandates, is not based on legitimate scientific information, imposes penalties for doctors providing patient care, and does not adequately consider maternal safety when requiring the administration of anesthesia to women. This legislation disregards the central tenets of medical ethics, which could lead to serious health repercussions for our patients.