[Congressional Record Volume 141, Number 27 (Friday, February 10, 1995)]
[Senate]
[Pages S2483-S2491]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                      FOSTER NOMINATION OBJECTION

  Mr. NICKLES. Mr. President, over the last 9 days, a firestorm has 
erupted over President Clinton's announcement that he intends to 
nominate Dr. Henry W. Foster as the Surgeon General of the United 
States.
  I believe that the President erred when he chose Dr. Foster as 
Surgeon General, and I believe the President should withdraw his 
nomination. I would also recommend to Dr. Foster that he withdraw his 
name from consideration.
  Mr. President, much has been made about the fact that Dr. Foster, by 
his own admission, has performed abortions. President Clinton said 
yesterday when he was defending Dr. Foster that the only people who are 
fighting this nomination are people who oppose abortion. I believe the 
President is wrong.
  Mr. President, I might mention that I do oppose abortion. I do not 
make any qualms about that. I do believe it is the deliberate taking of 
a human life, and I think it is a mistake to have as our Surgeon 
General a person who routinely performs abortions. To be named as 
Surgeon General, you are named as the Nation's No. 1 public health 
officer.
  Some people say, should a person be totally disqualified because of 
that? I would not vote for him, but that does not mean that this body 
would not. Likewise, I could not help but think of the reaction of many 
people in this body and what they would say if the medical researcher 
for American Tobacco Institute was appointed as Surgeon General. 
Smoking, like abortion, is legal, but I expect that there would be 
significant opposition because that is probably, again, not the right 
person to have as the Surgeon General.
  Mr. President, my reason for speaking today and my reason for saying 
that the President should withdraw the nomination, is not just because 
Dr. Foster has performed a lot of abortions. It is because in this 
period of 9 days, there has been a real lack of candor from Dr. Foster. 
There has been a real misleading of the American people and the 
American Congress to the facts. I think that alone disqualifies him for 
this office.
  The office of Surgeon General has been referred to as a bully pulpit, 
and it is. It is an office which gives the Surgeon General the ability 
to educate and to lead. And it is an office that, if one is going to 
educate and to lead by speaking, one has to have credibility. I think 
Dr. Foster has lost that credibility.
  Mr. President, this morning's New York Times, in the lead editorial, 
calls on President Clinton to withdraw the Foster nomination. The 
editorial states:

       Although Dr. Foster is a highly respected obstetrician, his 
     lack of candor about his abortion record disqualifies him 
     from serious consideration. Misleading statements by 
     candidates for high position cannot be condoned.

  The editorial concludes:

       President Clinton promises to fight for his nominee and Dr. 
     Foster pledges to stay the course. But this is a fight that 
     neither the White House nor Congress really wants over a 
     crippled candidacy. It is time to withdraw the nomination.

  Mr. President, I ask unanimous consent to have the New York Times 
editorial printed in the Record at this point.
  There being no objection, the article was ordered to be printed in 
the Record, as follows:

                [From the New York Times, Feb. 10, 1995]

                     The Tainted Foster Nomination

       The nomination of Dr. Henry Foster Jr. to be surgeon 
     general has been so badly bungled, by the White House and by 
     Dr. Foster himself, that there is little choice but to hope 
     it dies quickly. Although Dr. Foster is a highly respected 
     obstetrician, his lack of candor about his abortion record 
     disqualifies him from serious consideration. Misleading 
     statements by candidates for high position simply cannot be 
     condoned.
       Of course the chief blame for this debacle lies with the 
     White House, which once again put forth in a nominee without 
     adequately vetting the person's background or knowing the 
     answers to potentially explosive questions. As a result, the 
     Administration put out false information on the number of 
     abortions performed by Dr. Foster. In this as in earlier 
     episodes, White House bungling makes it difficult for 
     President Clinton's natural allies to support him fully. The 
     situation moves from difficult to impossible for 
     [[Page S2484]] pro-choice Republicans like Senator Nancy 
     Kassebaum of Kansas, who cannot reasonably be expected to 
     take a political gamble amid such swirling incompetence.
       That is a shame because Dr. Foster, based on his past 
     record, is a good choice to succeed Dr. Joycelyn Elders, who 
     was pushed from the job after her repeated intemperate 
     language made her a target for conservative attacks. Dr. 
     Foster, the acting director of Meharry Medical College in 
     Tennessee, is deeply committed to delaying child-bearing 
     among adolescents, one of the most pressing social issues 
     confronting the nation. He developed a highly successful 
     program, called ``I Have a Future,'' in Nashville that was 
     honored by President Bush as one of his ``points of light.''
       During a 30-year practice Dr. Foster, like many 
     obstetricians, performed a number of abortions. In doing so 
     he was providing a legal, constitutionally protected medical 
     service. If the latest numbers put forth are correct, he 
     performed 39 surgical abortions during his 38-year medical 
     career, a once-a-year rate that seems modest for a very busy 
     practitioner serving a needy population. He was also the 
     titular head of a federally sanctioned test of a potential 
     abortion suppository.
       This record would in any case have probably inflamed 
     America's anti-choice minority, which is fierce and well 
     organized and has good friends in Congress. But since most 
     Americans believe that women should retain the right to 
     choose, Dr. Foster's nomination might well have been pushed 
     through the Senate had his record been forthrightly 
     presented. Instead both he and the Administration made it 
     look as if there accounts were unreliable or designed to mask 
     a more troubling history.
       President Clinton promises to fight for his nominee and Dr. 
     Foster pledges to stay the course. But this is a fight that 
     neither the White House nor Congress really wants over a 
     crippled candidacy. It is time to withdraw the nomination.

  Mr. NICKLES. Mr. President, I do not often agree with the New York 
Times editorial page, but I think this editorial is correct. President 
Clinton should withdraw this nomination immediately because Dr. Foster 
has serious credibility problems.
  The New York Times editorial says Dr. Foster is guilty of lack of 
candor in making misleading statements about his abortion record. They 
are correct.
  In less than a week, he has given three different estimates on the 
number of abortions he has performed. Initially, he told the 
administration officials he had performed just one abortion. Then, last 
Friday, he issued a statement that said:

       As a private practicing physician, I believed that I 
     performed fewer than a dozen pregnancy terminations.

  Mr. President, I ask unanimous consent that a statement by Dr. Henry 
Foster on February 3, 1995, be printed in the Record.
  There being no objection, the statement was ordered to be printed in 
the Record, as follows:
Press Release: Statement by Dr. Henry Foster, Nominee for U.S. Surgeon 
                         General, Feb. 3, 1995

       My specialty in the practice of medicine is obstetrics/
     gynecology. I have personally delivered more than 10,000 
     babies in nearly 30 years of practice including my service in 
     the military.
       In that period of almost three decades as a private 
     practicing physician, I believed that I performed fewer than 
     a dozen pregnancy terminations. None were in out-patient 
     settings; all were in hospitals and were primarily to save 
     the lives of the women or because the women had been the 
     victims of rape or incest.
       I was also Chief of Service at two major teaching 
     institutions where many physicians held hospital privileges. 
     A wide variety of medical procedures and research was 
     performed at both. To my knowledge, all were in accordance 
     with the law and educational requirements.
       I have dedicated my life's work to improving access to 
     medical care and improving quality of life for women and 
     children, a passion rooted in my early years of practice in 
     the rural South. I have placed particular emphasis on 
     prevention, especially in such areas as teen pregnancy, drug 
     abuse and smoking cessation in children. In my work with 
     teenagers, abstinence has always been stressed as my first 
     priority.
       Through my long affiliation with Planned Parenthood 
     Federation of America, my person goal has always been to 
     provide education, counseling, preventive health care and 
     contraceptive access to patients needing such services. If 
     abortion is provided, my wish is that it be safe, legal and 
     rare.
       I am proud of my affiliation with Planned Parenthood just 
     as I am of my affiliation with many other prestigious 
     organizations such as the March of Dimes Foundation, the 
     American Cancer Society, the Y.W.C.A. and my church.

  Mr. NICKLES. Mr. President, on Wednesday, on ABC's ``Nightline,'' Dr. 
Foster recanted an earlier estimate and provided a new estimate of the 
number of abortions he has performed.
  Dr. Foster said:

       I have worked at George W. Hubbard Hospital. At Meharry 
     Medical College, all of my patient records and all of the 
     operative logs from the time I went to Meharry in 1973 until 
     tonight have revealed that I was listed as the physician of 
     record on 39 of those cases, in 38 years of practice, in 22 
     years at Meharry.

  Dr. Foster's statement on ``Nightline'' indicates he performed a 
grand total of 39 abortions in 38 years of medical practice, and all of 
those abortions were performed since 1973. But the Associated Press 
today reports that Dr. Foster performed an undetermined number of 
abortions prior to 1973, abortions that are not included in the 39 
abortions he admitted on ``Nightline'' to having performed.
  The article quotes Dr. Calvin Dowe, general practitioner and then a 
colleague of Dr. Foster at John A. Andrew Hospital in Tuskegee, AL, 
with William Hill, Dr. Foster's uncle, as saying Dr. Foster performed 
abortions in Alabama during the period from 1965 to 1973.
  The article states:

       Dowe and William Hill, Foster's uncle, said they do not 
     know how many abortions he performed at Andrew Hospital, 
     which closed in 1987. But both said Foster did only what was 
     medically necessary.

  The article also quotes Dr. Dowe as saying:

       I don't see how any obstetrician has said he has never done 
     an abortion. It's the nature of the business.

  Mr. President, I ask unanimous consent to have printed in the Record 
the article I just referred to.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

               [From the Associated Press, Feb. 10, 1995]

      Foster Was Lone Obstetrician For East Alabama's Black Women

                            (By Jay Reeves)

       Birmingham, AL.--As the lone obstetrician at a black 
     hospital during the days of racial segregation, Dr. Henry 
     Foster was the only source of health care for thousands of 
     poor, pregnant women in rural east Alabama.
       Foster delivered hundreds of babies at John A. Andrew 
     Hospital in Tuskegee from 1965 to 1973. When complications 
     left him no other choice, he sometimes did abortions, a 
     colleague and a relative say.
       ``Back then the medical treatment for Negroes was just 
     deplorable,'' Dr. Calvin Dowe, a former colleague of Foster, 
     recalled Thursday. ``Hospitals in the surrounding areas 
     didn't even consider them people.''
       While medical services were not segregated by law, Foster 
     cared for almost every pregnant black woman in at least five 
     counties.
       Dowe, a general practitioner who is black, said he never 
     referred women to Foster for abortions and did not know 
     anyone who did. Women simply went to him because there was 
     nowhere else to turn.
       ``Realistically, I don't see how any obstetrician can say 
     he never has done an abortion. It's the nature of the 
     business,'' Dowe said.
       Abortions performed by Foster over his 38-year medical 
     career have become a source of controversy since President 
     Clinton nominated him to replace fired Surgeon General 
     Joycelyn Elders. Foster, 61, initially acknowledged fewer 
     than a dozen of the procedures but now says he did 39.
       Dowe and William Hill, Foster's uncle, said they do not 
     know how many abortions he performed at Andrew Hospital, 
     which closed in 1987. But both said Foster did only what was 
     medically necessary.
       ``He had to perform some for medical emergencies. He wasn't 
     an abortion doctor,'' said Hill, 90, who still lives in 
     Tuskegee.
       Foster moved to Tuskegee in 1965 after completing his 
     residency at Meharry Medical College in Nashville, Tenn. Dowe 
     said the head of obstetrics at Andrew died about the same 
     time, and Foster agreed to take over.
       ``With the training he had, he could have gone a lot of 
     places. It was a form of mission work,'' Dowe said.
       Foster was a member of a Baptist church in Tuskegee, and he 
     took flying lessons under Charles A. Anderson, leader of the 
     famed Tuskegee Airmen, an all-black squadron during World War 
     II.
       Foster also developed what became a national model for 
     regional perinatal health systems. The White House was drawn 
     to Foster by programs he started later in Nashville 
     combatting teen-age pregnancy.

  Mr. NICKLES. These statements by Dr. Foster's former colleague and 
Dr. Foster's uncle indicate he has done more than 39 abortions in his 
38-year career.
  Again, we are talking about credibility. They indicate that Dr. 
Foster misrepresented his abortion record three times in the last week, 
and we still do not know, despite three different estimates supplied by 
the nominee, how many abortions Dr. Foster has performed.
  [[Page S2485]] Mr. President, there is a record that was made on 
Friday, November 10, 1978, at the Federal Building in Seattle, WA, 
before the Department of Health, Education, and Welfare, Office of the 
Secretary, an ethics advisory board.
  A list of participants included: Henry W. Foster, M.D., professor and 
chairman, department of obstetrics and gynecology, Meharry Medical 
College, Nashville, TN.
  Mr. President, on page 180 of this record, under Dr. Foster's name, 
it says:

       I have done a lot of amniocentesis and therapeutic 
     abortions, probably near 700.

  There is a lot in this transcript, Mr. President. There is a lot in 
this transcript, but this one line, Dr. Foster's words, ``probably near 
700.'' Initially from the White House we heard maybe the transcript was 
a forgery. Then we heard it probably was not this Dr. Foster, maybe it 
was a different Dr. Foster; maybe he was not there. I think they have 
recanted those statements and they said this probably is a legitimate 
transcript and it probably is the same person they nominated to be 
Surgeon General, but he did not say what the official transcript of the 
meeting says he said.
  Again, credibility. Was it 1 or was it 12 or was it 39 or was it a 
lot more before 1973? So we do not know how many.
  And, oh, yes, in his original comments he forgot that he was chief 
investigator of a drug, a suppository that would induce abortion that 
they gave to 60 people that he has written a report on, and I will 
include that for the Record as well. Out of the 60 pregnant women who 
participated in the study, 55 had their pregnancies aborted by the 
drug, and those abortions were not medically necessary. I think 58 of 
those who participated in the study were black women, ages 15 to 32; in 
55 of the 60 cases, the drug successfully induced abortion; in 4 other 
cases, they had to go ahead and complete a surgical abortion procedure; 
and in one case, the mother changed her mind and carried the baby to 
term.
  There are other things in this report. I am going to include this for 
the Record, not the entire report but I will include about 40 pages.
  This transcript includes a discussion about research, trying to do 
research to determine whether the fetus has a disease called sickle 
cell anemia and whether or not they can detect that disease prenatally 
or find out whether the fetus is affected in time so there could be a 
therapeutic abortion; in other words, abort a fetus because it happens 
to have sickle cell anemia.
  Mr. President, there are millions of Americans, I think it is 
estimated 2 or 3 million Americans who today have sickle cell anemia, 
and yet in this research proposal that they are talking to HEW about, 
they want to determine whether the fetus has sickle cell anemia so it 
would be in time to find out if the mother, I guess, would like to have 
an abortion, a therapeutic abortion. Not very therapeutic for the 
fetus, I might mention.
  It even goes on further, and I do not even like talking about this. 
It talks about research on human ova fertilized in a laboratory 
setting. Dr. Foster is saying, ``Well, if we have spares that are not 
used for insemination, they could be used for research.''
  It happens to be against the law right now, but he was advocating 
they would use fertilized ovum for research. That bothers me. This is a 
report, this is a transcript of a hearing. Maybe a lot of us speak at 
hearings and we forget we are recorded. I do not know. But these are 
statements.
  Mr. President, I would like to keep the Congressional Record very 
short, but this is a very controversial nominee and I think people are 
entitled to find out what the facts are. So I ask unanimous consent 
this portion of a copy of the ethics advisory board meeting dated 
November 10, 1978, be printed in the Record.
  There being no objection, the transcript was ordered to be printed in 
the Record, as follows:

 Department of Health, Education and Welfare, Office of the Secretary, 
          Ethics Advisory Board, Meeting V, November 10, 1978


                  members of the ethics advisory board

       Gaither, James C., J.D., Chairman, Cooley, Godward, Castro, 
     Huddleson and Tatum, San Francisco, California.
       Hamburg, David A., M.D., Vice Chairman, President, 
     Institute of Medicine, Washington, D.C.
       Conway, Jack T., Senior Vice President, Government and 
     Labor Movement Relations, United Way of America, Washington, 
     D.C.
       Foster, Henry W., M.D., Professor and Chairman, Department 
     of Obstetrics and Gynecology, Meharry Medical College, 
     Nashville, Tennessee.
       Henderson, Donald A., M.D., Dean, The Johns Hopkins School 
     of Hygiene and Public Health, Baltimore, Maryland.
       Lazarus, Maurice, Chairman, Finance Committee, Federated 
     Department Stores, Inc., Boston, Massachusetts.
       McCormick, Richard A., S.T.D., Professor of Christian 
     Ethics, Kennedy Institute for the Study of Reproduction and 
     Bioethics, Washington, D.C.
       Spellman, Mitchell W., M.D., Dean for Medical Services and 
     Professor or Surgery, Harvard Medical School, Boston, 
     Massachusetts.
       Williams, Agnes N., LL.B., Potomac, Maryland.
       Zwieback, Eugene M., M.D., Surgeon, Omaha, Nebraska.


                             staff members

       Dr. Charles McCarthy, Staff Director, EAB.
       Ms. Barbara Mishkin, Deputy Staff Director, EAB.
       Ms. Roberta Garfinkle, Assistant to EAB.
       Mr. William Dommel, Special Assistant to Staff Director, 
     EAB.
       Mr. Philip Halpern, Special Counsel to Chairman, EAB.
                         excerpts from hearing

       . . . given the risk benefit ratio and whatever--it would 
     not be ethical and moral for the government to pay for that 
     process.
       Dr. Leiman. So long as we are leaving the conceptus out of 
     the discussion, I think so.
       Mr. Gaither. Dr. Henderson, one last question.
       Dr. Henderson. Just an observation. I wonder if we are 
     really looking at proceeding on the assumption that there is 
     no additional risk. As one looks at the whole field of 
     medicine, almost any procedure one does, any drug one takes, 
     there is some minimal additional risk. Acceptable minimal 
     additional risk I think is the way we are really looking at 
     this and to say there is probably no additional risk I think 
     is probably not the way we can look at this. I think we must 
     say minimally acceptable additional risk.
       Mr. Gaither. I think the acceptable is still at issue. But 
     I think that the point is well taken.
       Rabbi Leiman, thank you very much. We appreciate it.
       Let's take a short break and figure out how we can get back 
     to our schedule.
       (Brief recess.)
       Mr. Gaither. Needless to say, we have fallen a bit behind 
     schedule, and I would suggest that we postpone for the time 
     being the legal discussion regarding in vitro fertilization, 
     and proceed at this time to a consideration of the research 
     application involving fetoscopy, submitted by the Charles 
     Drew Postgraduate Medical School.
       I would like to note at the outset that Dr. Spellman, 
     formerly Dean at that medical school has asked that he be 
     excused from the deliberation on this issue. I hope that you 
     will stay with us and listen to it, but I understand your 
     reluctance to become involved, and we will assume that you 
     will not be involved in either the discussion or the decision 
     on this issue.
       Dr. Hamburg. However, as a point of personal privilege, you 
     may respond to insulting remarks. (Laughter.)
       Mr. Gaither. Mrs. Mishkin, we will let you describe the 
     issue before us, and I would ask that you start by describing 
     why the application is before us and what we are expected to 
     do with it.
       Ms. Mishkin. The HEW regulations governing research 
     involving the human fetus lay down certain conditions which 
     must be met in order for an institutional review board to 
     approve that research. If the institutional review board is 
     not able to determine that all of the conditions have been 
     met, and if it considers that the research nevertheless is 
     important, it may refer that research proposal to this Board 
     for review. And if the Board determines that the research 
     should go on, it may recommend to the Secretary that he waive 
     those parts of the regulations that the research proposal 
     cannot meet.
       Now, the proposal before the Board at this point is a 
     proposal to perform fetoscopy on mothers who have elected to 
     have abortions for reasons totally unrelated to the research, 
     in order to discover and to document what the risk to mothers 
     and fetuses might be from the procedure of fetoscopy. The 
     purpose of developing the fetoscopy is to be able to diagnose 
     prenatally certain conditions for which the parents are at 
     risk. In this particular research proposal the focus is 
     primarily on prenatal diagnosis of sickle cell disease.
       Now, the reason that this proposal is before the Board is 
     that it cannot meet or at least cannot clearly meet 
     provisions of the HEW regulations set forth in sections 
     46.206(a), 46.207(a), and 46.208(a) which briefly, taken 
     together, require that the activities in the research 
     proposal be designed to meet the health needs of either the 
     mother or the particular fetus involved, or, if that is not 
     the case, that the procedures present no more than minimal 
     risk to the fetus.
       [[Page S2486]] Now, the problem in this proposal is that it 
     is
      not designed, as written, to provide therapy for the mother, 
     nor is it designed to provide therapy for the fetus, 
     because the purpose is to assess safety of a technique and 
     to do it in mothers who have already elected to undergo 
     abortion. So there is no question as to whether or not it 
     is or not so-called therapeutic research. It clearly is 
     not. Therefore, it does not meet that first condition.
       It does not seem to meet the second condition because the 
     risks, I think, must be considered undetermined. Although the 
     HEW regulations do not define minimal risk, it is possible to 
     go and look behind those regulations to the Commission's 
     discussion of what they intended, because the regulations 
     were an attempt by the Department fully to implement the 
     Commission's recommendations on research involving the fetus.
       So I am going to offer to you for your guidance what the 
     Commission's intentions were when they made their 
     recommendations to the Secretary. That does not mean that you 
     must follow the Commission's intentions; it is only to 
     elucidate for you somewhat what the Commission had in mind, 
     because the regulations themselves give this Board no 
     guidance. The only guidance in the regulations is to the 
     institutional review boards.
       Mr. Gaither. Let me interrupt for just one second, because 
     I think it is important that we understand the standards 
     which we are to apply. I gather what you are saying is that 
     this particular application is not therapeutic and not 
     clearly within the category or at least so determined by the 
     institutional review board, as involving no more than minimal 
     risk.
       Ms. Mishkin. That is correct.
       Mr. Gaither. Therefore, it can only be funded if this Board 
     determines that it is ethically acceptable? Is that the 
     standard?
       Ms. Mishkin. Essentially, yes. If we recommend to the 
     Secretary that he waive those provisions that we just 
     mentioned because we feel the research is important and 
     justified by the benefits to be obtained from the--the 
     anticipated benefits.
       Mr. Gaither. So there is no particular standard other than 
     for us to say to the Secretary whether or not we feel that he 
     should go ahead despite that provision in the regulations?
       Mr. Halpern. Mr. Gaither, if I could be of help, if you 
     look at subpart 5 under Tab I in our book, giving us the 
     regulation, Section 46.211 provides some guidance as to the 
     standard, at least which will guide the Secretary in his 
     decision to accept our recommendation.
       Ms. Mishkin. At Tab I of your book, we have reproduced the 
     applicable provisions of 45 CFR 46, and it simply says if 
     this Board feels that the risk is justified by the sum of the 
     benefit to the subject, which is not in question here, or the 
     importance of the knowledge to be gained.
       Mr. Conway. And you are referring us to 46.211?
       Ms. Mishkin. Yes.
       Mr. Halpern. In fact, it doesn't say that the Board should 
     be guided by the risk benefit analysis, it says that the 
     Board should consider whether waiver, which is what we are 
     talking about, is appropriate in this particular instance. 
     Then it says in making the decision the Secretary will 
     consider whether the risks to the subject are so outweighed 
     by the sum of the benefit to the subject and the importance 
     of the knowledge to be gained as to warrant such a 
     modification or a waiver.
       Mr. Gaither. But it seems to me that it is important for us 
     to note that .211 states that the Secretary can only waive, 
     unlike the other situation before us, with our approval. So 
     that is the question, whether we would approve a modification 
     or waiver of these regulations to permit this research to 
     continue. And basically there are no specific standards 
     imposed upon us. Is that correct?
       Ms. Mishkin. That is correct.
       Mr. Gaither. And what you are giving us is the background, 
     now, for these particular regulations why the Commission 
     suggested that a body such as ours be involved in the 
     deliberations.
       Ms. Mishkin. And what the Commission coped with when it 
     discussed the problem of research on fetuses to be aborted, 
     and what standard might be appropriate in considering 
     acceptable risk to fetuses about to be aborted or whose 
     mothers intend to go through with an abortion. It was a very, 
     very difficult problem for the Commission. Any of you who 
     followed the Commission's activities in this area will know 
     they spent a long time on this, and this was one of the areas 
     in which there was not a full consensus among the Commission 
     members.
       First of all, let me say that this particular application 
     underwent six reviews prior to coming before this Board. That 
     included reviews by the appropriate IRB at the Drew Center; a 
     review by the community board which is a separate community 
     representative board at the Drew Center; review by the 
     appropriate study section at HEW; review by a site visit team 
     from study section, members ad hoc; review by the National 
     Advisory Council under whose auspices this particular 
     application came--if that is not six I have left one out, but 
     they are all listed there anyway.
       The staff of the Board then shipped the whole thing out to 
     two additional people for independent reviews, and those have 
     been mailed to you and are reproduced in your book. Dr. Haig 
     Kazazian at Johns Hopkins University Hospital, and Dr. Dwayne 
     Alexander at the National Institute of Child Health and Human 
     Development.
       Dr. Kazazian has done fetoscopy himself; he no longer does 
     so. Dr. Alexander has not done fetoscopy. He was a member of 
     the staff of the Commission and he ran the amniocentesis 
     collaborative research program, and is very familiar with 
     questions of prenatal diagnosis, and the risks of various 
     procedures associated with prenatal diagnosis.
       All of the review boards and the individual reviewers have 
     recommended approval of this research application based on 
     the importance of being able to diagnose prenatally certain 
     conditions which, up until now, have not been diagnosable 
     through amniocentesis. Fetoscopy has been the only possible 
     way to diagnose sickle cell disease, among other diseases, in 
     fetuses prior to birth.
       Now, there was one problem that we had in reviewing this 
     particular proposal, and that was it was not entirely clear 
     from the proposal, because we had conflicting statements--the 
     site visit review said one thing, and the proposal said 
     something else--as to whether or not the investigators 
     planned to delay abortion for more then 24 hours after 
     fetoscopy. The point of the research is to do the fetoscopy, 
     monitor the women after fetoscopy, and look for complications 
     as a result of fetoscopy. Complications include possible 
     infection of the woman, possible bleeding of the fetus, and 
     subsequent abortion prior to the induced abortion which is 
     anticipated.
       What is present in the research application is a plan to 
     perform the fetoscopy, monitor the woman for 24 hours, and 
     then go ahead with the abortion as planned. What is present 
     in the site visit's review, however, is a plan to continue 
     monitoring, if they are satisfied that a 24 hour delay poses 
     no risk, to increase that delay step by step, until they 
     reach, finally, a two-week delay during which they would 
     monitor the woman for two weeks following fetoscopy before 
     going ahead with the abortion.
       I called the principal investigator to find out what in 
     fact was their intent, and he said that this does seem--that 
     it is his intent to go incrementally if they are satisfied at 
     any one stage as to the risk to mother and fetus, to go 
     incrementally up to a two-week delay. This raises a very 
     important concern that their
      subject population is women who are in their 16th to 20th 
     week of gestation. A two-week delay in a woman who 
     presents at 20 weeks would take that woman past 20 weeks 
     gestation before her abortion, and this then would run 
     into the possibility of a viable fetus being aborted, or 
     of having a viable product of the abortion. This is one 
     problem that the Commission was very much concerned about. 
     That is why the staff recommendation on this particular 
     proposal includes the provision that no abortion be 
     postponed for reasons of this research that would then 
     have to be performed after the 20th week of gestation. 
     This is compatible with the regulations that no timing or 
     methodological change be introduced for reasons of 
     research that would add additional risk to the mother or 
     the fetus. And surely the risk of having a viable product 
     of abortion is an additional risk.
       The current regulations note that viability is possible at 
     20 weeks, and that is why the staff recommends that no 
     procedure be delayed beyond the 20th gestational week for 
     purposes of this research.
       Now, the whole thing was complicated by an article in the 
     Washington Post that appeared on Saturday, November 4th, 
     while we were in the process of preparing this memorandum of 
     recommendations to you. That article indicates that a 
     physician at the University of California at San Francisco 
     believes he has developed a procedure to diagnose sickle cell 
     disease through amniocentesis, thus avoiding the necessity to 
     go to fetoscopy in order to diagnose sickle cell disease. 
     These findings are supposed to have been in the most recent 
     issue of the journal Lancet. We were unable to find whatever 
     issue that was. It must not be out yet. If it is out it is 
     not available in any of the libraries we had access to in 
     Washington.
       We tried very hard to call the investigator at the 
     University of California at San Francisco, and we were unable 
     to reach him. We do, however, have some further information 
     on that. Dr. Alexander was able to reach Dr. Michael Kaback, 
     who is Assistant Professor of Pediatrics and Medical Genetics 
     at the University of California at Los Angeles, and who is 
     familiar with the work of the investigators at San Francisco.
       What I am going to give you now is my understanding of Dr. 
     Alexander's understanding of Dr. Kaback's understanding of 
     what they are doing in San Francisco. If all of that is 
     clear, you will know how far we are removed from firsthand 
     information. But nevertheless I will give it to you, because 
     I think it is important.
       It goes as follows: 85 percent of sickle cell carriers have 
     an extra large piece of DNA on the gene that has the sickle 
     cell trait. Now, this condition of having the extra large 
     clump of DNA material is calling polymorphism. Thus, it is 
     possible assuming the test works as reported, to diagnose 
     approximately two-thirds or more of sickle cell babies 
     through amniocentesis and looking for this enlarged DNA 
     clump.
       Now, let me break that out for you. What they have to do if 
     they identify both parents as carriers, they then look for 
     this polymorphism, in other words, the extra clump of DNA in 
     the parents. If those parents have that extra clump of DNA, 
     that is, if they fall within the 85 percent of sickle cell 
     carriers 
     [[Page S2487]] who have that polymorphism, then it is 
     possible to perform amniocentesis--yes?
       Dr. Foster. I should clarify something at this point. You 
     are using a medical term, and I am not sure--you are saying 
     ``carriers.'' do you really mean carriers, or do you mean 
     sickle cell disease?
       Ms. Mishkin. No, I mean carriers.
       Dr. Foster. That is not a person with sickle cell disease.
       Ms. Mishkin. That is correct.
       Dr. Foster. Okay.
       Ms. Mishkin. But again, this is my understanding from Dr. 
     Alexander through Dr. Kaback. That is the best we can give 
     you.
       Dr. Foster. Go ahead and let me hear you out, then.
       Ms. Mishkin. My understanding is this is carriers.
       Dr. Foster. Okay, go ahead. I will hear you out.
       Ms. Mishkin. So if both parents are carriers, either with 
     or without the disease--
       Dr. Foster. It is the previous I am concerned about.
       Ms. Mishkin. Right. If both parents are carriers and have 
     this trait of the polymorphism, and it is possible to be a--
     15 percent of carriers do not show this trait. If they are 
     among the 85 percent of carriers who show this trait, then 
     through amniocentesis they can look for the segments in the 
     fetus. If the fetus has two segments showing the polymorphi, 
     that is a child with sickle cell disease. If the fetus has 
     one segment that child is a carrier. If the fetus has no 
     segments, that is a normal child.
       Now, I went back and asked again whether that child could 
     be one of the 15 percent that do not show the polymorphism, 
     and the answer was that Dr. Alexander believes not. The 
     answer is if they have done this whole procedure and the 
     child does not carry that polymorphism, that child is not a 
     carrier or a diseased child with respect to sickle cell.
       Now, if either parent is not polymorphic, does not have 
     this additional clump, is within that 15 percent of parents 
     who are carriers but do not have this change of the DNA, then 
     it is impossible to diagnose the sickle cell disease in the 
     fetus through this amniocentesis procedure, and that would 
     mean that for those parents the only way to diagnose the 
     sickle cell disease in the fetus would be through fetoscopy, 
     which brings us back to the Drew application.
       Now, what all this means is there has been a shift in the 
     risk benefit analysis that all of the reviewers performed on 
     the Drew application, because when they looked at the Drew 
     application fetoscopy was the only method for diagnosing 
     sickle cell disease prenatally. Now it appears, although we 
     do not have the documentation to give you, that it is 
     possible in 85 percent of sickle cell carrier parents to 
     diagnose the presence or absence of sickle cell disease by 
     anmniocentesis which is agreed to be a safer procedure than 
     fetoscopy.
       So your job is somewhat more difficult, but I don't think 
     it is impossible. One is left with the question of whether it 
     is appropriate for the investigators at Drew to do the 
     research, to assess the risks of fetoscopy as a tool for 
     prenatal diagnosis of sickle cell disease in their subject 
     population, and the reason I am emphasizing this is that if 
     it were the case that all sickle cell disease could be 
     diagnosed prenatally through any other method, amniocentesis 
     or any other, then the board would have to face the question 
     of whether the subject population which the Drew Medical 
     Center serves is an appropriate population to develop the 
     methods of fetoscopy. Fetoscopy is useful for prenatal 
     diagnosis of other disorders, but not disorders which are 
     disorders of the black population, which is the subject 
     population which the Drew Center serves. So then one would 
     have to question whether the black population is an 
     appropriate subject population for developing fetoscopy if 
     they are not going to be the population which will benefit 
     from the development of that diagnostic tool.
       In other words, one wants to have the population that will 
     benefit from the research, participate as subjects and accept 
     the risks of that research if possible.
       Mr. Halpern. Just related to this, are we not also in the 
     position of asking whether or not we should remand this issue 
     to Drew and the community that Drew serves for them to make 
     the risk benefit analysis again, in light of this new data?
       Ms. Mishkin. Absolutely. That is a very viable option, and 
     it certainly has a great deal of merit. I think one might 
     reasonably ask for a total reassessment, by that IRB or by 
     any number of other people, even including the study section 
     that reviewed it, in the light of the new information. But I 
     think we would want to get the actual information documented 
     before we remanded it.
       I don't know if this has been clear, and if you want more 
     elucidation of the Commission's intent or of my understanding 
     of the regulations, I would be glad to go forward with more.
       Mr. Gaither. Hank, would you say something about the 
     science of this?
       Dr. Foster. Yes, I am going to say something about the 
     science and the sociology, if you will indulge me.
       I heard of Kan's work just a few days ago, and I knew 
     clearly like a shock wave that it was inevitably going to 
     affect what we have to do, or what we recommended. But I want 
     to say some things as we go through all of this deliberation, 
     which may take me a few moments, but I really want to run 
     through these steps that I have written down here. Some food 
     for thought.
       I just have one question. The genetic polymorphism that is 
     necessary in the parents--is it required in both parents? In 
     other words, you know, both parents may be carriers, but only 
     one may show the polymorphism and the other may not. Is it a 
     requirement for both parents? Do you recall?
       Ms. Mishkin. My understanding is that it is not going to be 
     a reliable test through amniocentesis unless both parents 
     show the polymorphism.
       Dr. Foster. Now, the next question I have--and then I will 
     make my comments--now, I read the research proposal, and I 
     missed this delay. That bothers me a little bit, first. I 
     have got to really clear that in my mind.
       I have done a lot of amniocentesis and therapeutic 
     abortions, probably near 700. As I read the protocol, the 
     patient would be brought in the hospital, and that would be a 
     24 hour delay, which was not inordinate, based on the 
     information that we have. It is very reasonable. But the 
     clinical part, catheter is introduced into the amniotic 
     cavity, and that is the time when the fetus is studied, the 
     blood vessels, and the sample is taken. Then the fetoscope is 
     withdrawn, but the catheter is left in place, which is quite 
     acceptable. In fact, this is one of the techniques we use for 
     continuous prostaglandin infusion.
       But there gets to be a real question with regard to 
     infection after a 24 hour period with an indwelling 
     connection to the outside. I missed the entire reviewer's 
     section about some extension beyond 24 hours, and if there is 
     an extension of observation beyond 24 hours, does it involve 
     the catheter being in place? This would be critical in my 
     mind.
       Dr. McCarthy. Yes, it certainly does.
       Dr. Foster. I think that is something that really needs to 
     be addressed in terms of the details of the research.
       Ms. Mishkin. I am frankly bothered by anything coming as 
     far as to the Ethics Advisory Board through all those reviews 
     without this being quite clear. It was in the site visit 
     review, and it was because of the ambiquity that I called the 
     principal investigator.
       Now, Dwayne Alexander was working on the application in 
     front of him, and so he really addressed only the 24 hour 
     delay. But because of the ambiguities I did call, and the 
     investigators do intend to go to two weeks. I think it might 
     not be inappropriate for the Board to make some strong 
     statement about wanting to be clear on what the procedures 
     proposed are here.
       Mr. Lazarus. I wasn't clear either on the consent 
     procedures.
       Dr. Foster. That doesn't come through. But the one thing I 
     do want to say, and then I will get to the other
      points I want to make about what all of the implications of 
     fetoscopy are as I see it. I do think a longer 
     observational period is an acceptable research modality 
     provided safeguards are there. We have already talked 
     about extending beyond the 20 weeks. That can be 
     controlled for fairly well with ultrasonography for 
     establishing fetal age, and a few other things. But I 
     think you might want to consider the observation period 
     without the catheter in place, because repeated 
     amniocentesis has proven to be relatively safe in terms--
     the danger is in leaving a conduit for bacterial 
     migration.
       So what I am really saying is I can see the investigators 
     making a justification for an observation period of longer 
     than 24 hours, but I find it a little difficult at this point 
     to see that justification with an indwelling catheter in 
     beyond this point.
       And now I think the things we need to be concerned about 
     irrespective of what we ultimately recommend in terms of 
     going back or whatever. There was very, very strong community 
     support for this proposal. Anyone who read the type of 
     support, and the rather incisive and critical questions, I 
     thought, that the community asked in regard to many of the 
     social and medical implications. I think it is keen that we 
     remember that there have been so many charges of disregard 
     for ethic makeups of our research, genocide and all the 
     issues, if this is an indigenous decision by a community, I 
     think we need to give that great respect, because it is a 
     justification for us to say this is a decision that you made. 
     If we say to the community no, we shouldn't do this, the 
     community in a sense has a right to say you are willing to 
     impose certain things on us externally that we feel are an 
     abridgment, but here when we see something clearly directing 
     us, you deny it. So that is something that has to be 
     considered strongly in terms of sociology.
       I think another thing that is very important from what I 
     know about this--Drew has been one of the few centers that 
     had federal support prior to the moratorium in 1973, I 
     believe, involving aborted fetal subjects on the research, 
     has gone through the steps of animal experiments. They have 
     used the ovine model very well with sheep and I think we 
     certainly have to give that some accord. They have gone 
     through all the steps prior to using humans.
       Now, the implications of Kan's work I don't need to go 
     over. You have made that very clear. So I will move on to my 
     fourth point.
       Mitch Spellman makes this point a lot, and it is a good 
     point. There is a basis for basic research with regard to 
     doing fetoscopy, irrespective of Kan's work. There 
     [[Page S2488]] is a basic need. Now, I am going to go slowly 
     and really try to make this point.
       Kan's approach right now is the acceptable one. It is a 
     reaction. It is an after-the-fact approach. It gives us an 
     option simply to abort a defective pregnancy. Basic research 
     will afford us a much broader and brighter horizon, might I 
     add. And that is the possibility of diagnosing the defective 
     fetus and then preventing the development of sickle cell 
     disease in that fetus.
       Now, I will try and paint a picture. In utero, for all of 
     us normally, there is a different set of protein in two of 
     the chains of our hemoglobin in early fetal life. The normal 
     hemoglobin molecule has four chains, two upper alpha chains, 
     which are proteins in a set sequence, and two lower, somewhat 
     larger, beta chains in a set sequence.
       The only difference between one who has sickle cell 
     hemoglobin and a normal person is out of 184 amino acids in 
     one of those chains, and that is in set sequence, there is an 
     exchange of valine for glutanic acid, in the sixth position 
     from the end. One of 184 chains. That is the only difference. 
     But because of this change in the chain, certain physical and 
     chemical defects, as you may call them, are imparted into the 
     hemoglobin. It makes it less stable. Its ability to hold and 
     release oxygen is affected. The stability of the red cell 
     membrane is affected.
      It changes its pattern of migration in an electrical field. 
     This is how we do our hemoglobin electrophoresis.
       Back to in utero, none of us has these beta chains when we 
     are developing. We have another chain called a gamma chain, 
     and that gamma chain is provided for through a mechanism 
     which we yet do not fully understand, and this is where our 
     basic research should continue. There are repressor genes and 
     activator genes. Rarely, through chance, some people who were 
     destined to have sickle cell disease never develop it. But 
     they continue to make the gamma chains which make fetal 
     hemoglobin throughout life, even in the postnatal period. And 
     these people have absolutely no trouble. That is the ideal 
     situation for the sickle cell person, is to be able to find 
     that mechanism that will prevent the turning on of the 
     activator genes from going from gamma chains to defective 
     beta chains. So there is a clear need for this kind of 
     research in spite of the work by Kahn and his group.
       It is at this basic step where not only will we be able to 
     diagnose the child destined to have sickle cell disease, but 
     indeed, to prevent it. So I think that alone justifies 
     continuation of this basic research approach.
       Lastly--well, that includes--I wanted to say something 
     about the basic science of the molecule. So there is a real 
     horizon out there that has to be untapped, and that is the 
     ability to diagnose the abnormal hemoglobin but not by 
     default to get rid of the fetus. That is the thinking that if 
     you want to prevent forest fires, cut down all the trees. I 
     want to take a different approach. I want to see can we 
     afford this fetus that was destined to be one thing, that our 
     basic research will continue to allow us to do something 
     about it.
       So I just wanted these thoughts to be in the back of our 
     minds, particularly in light of Kan's recent work as to the 
     obsoleteness of this continued basic research approach.
       Ms. Mishkin. Is the research to develop that therapy now 
     ready for pursuing through fetoscopy now, or does one have to 
     wait for more development in animals and other methods before 
     you actually go to fetuses in utero?
       Dr. Foster. I think I understand your question, Barbara. 
     Are you saying is our technique to such a point that we can 
     go ahead with just the technique of amnioscopy?
       Ms. Mishkin. No, I am asking whether one would endorse the 
     Drew application today on the basis of the need to develop 
     the prenatal therapy, or are we not yet there with respect to 
     the therapy, with the animal work and so forth?
       Dr. Foster. I think the animal work has been done. I think 
     that has been satisfied.
       Ms. Mishkin. There is one other thing I forgot to mention 
     on the risk benefit analysis, and that is the concern about 
     using fetuses to be aborted. There is not much direction in 
     the HEW regulations on this matter, but the Commission came 
     down to a guideline that may or may not be useful for you, 
     but I think it has some merit. That is, they felt that it was 
     ethically acceptable to perform procedures on a fetus to be 
     aborted if one would feel ready to perform those procedures 
     on a fetus intended to go to term.
       In other words, if one had done all of the animal work, 
     including primate work, which they have done in this case, 
     and if they were unable to do it on fetuses to be aborted to 
     further assess the risk, if they would be willing then to go 
     forward therapeutically with it on fetuses going to term. 
     That condition has been met in this case, because there are 
     apparently several groups who are performing amniocentesis on 
     fetuses intended to go to term.
       Father McCormick. Fetoscopy, you mean?
       Ms. Mishkin. In fetoscopy, yes.
       Mr. Gaither. In somebody's judgment.
       Ms. Mishikin. I mean the condition of its being performed 
     on fetuses going to term has been met, and the
      question is whether or not that meets your feeling of 
     acceptability for performing the procedure on fetuses to 
     be aborted. But this procedure is being performed on 
     fetuses going to term.
       Mr. Gaither. Can I just ask for some clarification, first? 
     One, what are the purposes of this particular protocol? Is it 
     particularly experience and safety, or does it get into the 
     basic research questions that Dr. Foster was mentioning?
       Ms. Mishkin. My understanding of the protocol is that it is 
     to assess the risks of infection, of bleeding, of premature 
     abortion, and so forth, that are attendant with fetoscopy. 
     Now, Dr. Alexander also sees an additional benefit, which is 
     developing the competence of the investigators to perform the 
     procedure prior to trying to do it on fetuses going to term. 
     That also is included. That is not the primary purpose of the 
     application as written. The application is to determine with 
     somewhat better certainty the risks involved to mother and 
     fetus.
       Dr. Foster. And a part of that is improving the technique. 
     It is not basically designed to go into a specific basic 
     research question. As I understand it, it is what Barbara 
     says, to assess the safety and to improve the technique. That 
     is going to evolve from that. And that is one of the reasons 
     I feel they are asking for a somewhat longer observation 
     period, because if you do the procedure and then proceed 
     directly to the termination, you would deny some of the 
     longer term effects, delayed bleeding and the like.
       Mr. Gaither. Two further points of clarification, and then 
     I will open the discussion. The work that is presently going 
     on at Yale and the University of California, has that been 
     subjected to these regulations and approved, the distinction 
     being that it was therapeutic, that is, regarded to be of 
     benefit to a possible child, and that is why it is different, 
     or not? Do you know what the status is?
       Ms. Mishkin. I am not entirely clear. My understanding is 
     probably not with respect to the Yale group, because I do not 
     think that is funded by HEW. I believe that is the 
     information we got from Jerry Mahoney just recently. But as 
     you know, the regulations are somewhat ambiguous with respect 
     to whether or not research conducted at an institution but 
     not funded by HEW must be reviewed by the IRB, and also 
     subject to the same review standards. So it is a somewhat 
     unclear point with respect to the Yale group.
       Dr. McCarthy. It is perfectly clear that the Yale group 
     felt obliged under Section 474(b) of the Public Health 
     Service Act to have Dr. Mahoney's research involving 
     fetoscopy reviewed by the IRB. They also made the 
     interpretation, which I think is a reasonable one, although 
     not the only possible one--they made the interpretation that 
     they need not review according to HEW standards. And in fact, 
     there is some question in my mind as to whether Dr. Mahoney's 
     work would have been acceptable under HEW standards, because 
     I think they regard this as more than minimal risk--not a 
     great deal more, but somewhat more than minimal risk. 
     Therefore, if they had followed our standards, his work would 
     have had to come to the Board. Because it is not funded by 
     HEW, they decided they could make that decision and they have 
     made it and are carrying out that work.
       Mr. Gaither. There would not have been a distinction based 
     on their work being therapeutic and this work not, because of 
     the abortion?
       Dr. McCarthy. No. As I understand it, initially they--and I 
     am not quite sure at what phase they are in. They have 
     planned a series of steps, the later stages of which they 
     intend to be therapeutic. As I understand it, they are still 
     in the diagnostic phase of those steps, but I believe their 
     approval goes all the way to--assuming all the other stages 
     are carried out with no untoward events--they intend to go 
     all the way to applying fetoscopy to therapeutic 
     interventions to try
      to assist fetuses that are in one way or another abnormal.
       Mr. Gaither. Mr. Lazarus?
       Mr. Lazarus. I think one of the key issues in this request 
     is the problem of risk and how it is presented to the 
     patient. Barbara says in her note that the risk presented by 
     research cannot be characterized as minimal. Rather, it 
     should be considered undetermined. And yet, the patient 
     consent states that ``I have been advised that these risks 
     are minimal to me and to my fetus.''
       I think that one of the items that must be clarified is the 
     whole consent procedure, and the nature of the risk must be 
     spelled out a lot more consistently than they are spelled out 
     under the present consent procedure that has been presented 
     by Drew.
       Ms. Mishkin. I think one of the problems is that minimal 
     risk, as I pointed out, is not defined in the HEW 
     regulations, and in the Commission's report and its 
     deliberations, that was a problem in two areas. At one point 
     they indicate--and they indicate more strongly in subsequent 
     reports--that risk which has not yet been determined should 
     not be classified as minimal, but should remain under the 
     categorization of undetermined.
       On the other hand, there were some Commissioners although 
     not all of them--there was a difference of opinion on this 
     point, as to whether when you are talking about a fetus to be 
     aborted, one can consider risk of abortion as a minimal risk 
     to that fetus, whereas one would not consider risk of 
     abortion a minimal risk to a fetus intended to go to term. 
     This was one of the very difficult points where there was a 
     lack of consensus among the Commission members.
       So I think that when the IRB and the various people who 
     reviewed the Drew application determined that it was minimal 
     risk, that was not a clearly unacceptable determination. It 
     was simply their interpretation, 
     [[Page S2489]] given very little guidance from the Department 
     as to how to assess and categorize that risk.
       Mr. Lazarus. It would seem to me, though, that a patient's 
     consent is very important with the nature of the risk, which 
     is undetermined. It should be very carefully spelled out.
       Mr. Gaither. Particularly when one is conducting the 
     research for the purpose of finding out how risky the 
     procedure is.
       Mr. Lazarus. Right.
       Mr. Halpern. Underlining the illogic of the word 
     ``minimal'' where you are saying we don't know what it means, 
     well, the problem is it is in our HEW regulations, and if in 
     fact the risk is minimal as the patient is told, it wouldn't 
     be here.
       Ms. Mishkin. That is right. It would not be before this 
     Board if the risk were minimal. Then the IRB could have 
     approved the project by themselves, although there is another 
     provision that would need a waiver, so it probably would come 
     here anyway. That is, the regulations currently provide that 
     there be no change in timing or procedure of an abortion for 
     research purposes that would add any additional risk, and 
     that provision does not say ``that would add more than 
     minimal risk,'' but that ``would add any additional risk.'' 
     So it might have had to come here even so.
       Dr. McCarthy. But the determination, the very point that 
     Mr. Lazarus made, was picked up in the Office for Protection 
     from Research Risks, which refused to--even though it had 
     been reviewed by all of the subsidiary bodies--refused to go 
     ahead and fund until and unless it has been approved by this 
     Board.
       So it is that very point: If you are doing research to 
     assess risk, it does not seem possible then to prejudge the 
     outcome by calling it minimal. It may turn out to be minimal, 
     but there is no justification for the research if you already 
     know it is minimal.
       Mr. Lazarus. And you are getting your consents under a 
     false clause.
       Dr. McCarthy. Yes, and I think the Office for
        Protection from Research Risks was correct in making the 
     judgment that it should come before this Board to comply 
     with HEW regs.
       Mr. Gaither. Yes, Dr. Henderson?
       Dr. Henderson. Let me just carry that a little further. One 
     of the important criteria here is that the research is 
     important and justified. I think this is what is indicated. 
     Clearly we have got investigators who are very competent 
     people and they have obviously proceeded step by step in 
     reaching the point they have.
       I guess there are a couple of things in my own mind that 
     are rather unclear. There are two centers where the work is 
     being done now, Toronto and New Haven, where the risks now 
     appear to be rather small. I think this is perhaps where the 
     statement is that it is probably a minimal risk, that 
     experienced people following along with two other centers, 
     and doing what I interpret or what I understand is the same 
     procedure that they are doing in New Haven and Toronto.
       The question I guess I have, then is is it necessary to 
     fund yet a third center? Should HEW fund a third center to be 
     doing this? What are the advantages?
       The initial point here, as they say, initially it is 
     limited to an assessment of the safety. I find that fully 
     justified to go--initially one is doing a study to assess the 
     safety. But then I ask what is the ultimate objective, 
     because we want research which is important and justified. 
     What is it leading to? Obviously there is an objective here.
       I believe, as I interpret it, that they would hope to be 
     defining sickle cell disease. Now, I think in talking with 
     you earlier, the question is can you identify either the 
     sickle cell trait or sickle cell disease before 30 weeks? Can 
     you define it at this period in time?
       Perhaps we are talking about, as you mentioned earlier, 
     longer term basic research, which requires this technique to 
     be used. Is it enough to say that it is important that we do 
     longer term basic research employing this technique without 
     defining what is that basic long term research, and are we at 
     the point now to approve of this sort of application which is 
     based on safety, for some sort of ill-defined subsequent 
     future, when in fact we are supposed to be judging this that 
     the research is important and justified.
       Now, it is obvious that there are a lot of very good people 
     who have looked at this, and I am asking the questions, I 
     would say, out of ignorance, because I found some 
     contradictions here which I am having trouble with.
       Father McCarthy. Do you want to respond to that, because I 
     have got a different point I want to raise.
       Dr. Foster. Well, yes. I tried to make some of them and I 
     will try again. I think there are quite a number of 
     justifications, Don, for continuing. One of the biggest 
     reasons--I think the assumption is not completely correct 
     that this work is being done at the other centers. I don't 
     think there is anywhere the proportionate interest in sickle 
     cell disease at either other center, nor is there the 
     particular population base in either other center to be able 
     to address this effectively.
       Even if Kan's work proves to be what it is purported to be, 
     based on what Ms. Mishkin has said, we are still left with 15 
     percent of a large population that is at great need, as you 
     are probably aware. About eight percent of the blacks in this 
     country harbor the sickle cell trait, and that is 2.5 million 
     people, and 15 percent of that is a large port of the 
     population.
       So I think there is still in our current state of the art 
     to continue to try and be able to diagnose sickle 
     hemogloginopathies prior to the 30th week. I think there may 
     be ways that we can do it. As yet we can't do it very 
     reliably.
       So I think the justification for continuing this work is 
     clearly there. The justification may not be
      as strong as it was, but I certainly think it is within the 
     realm of acceptability. This is what I personally feel.
       Let me say one other question while I have the microphone. 
     Let me address one other question regarding therapy versus 
     research. I have not seen the research proposals that John 
     Hobbins had at Yale, or what Kan has done at USC. But I do 
     know that a lot of their fetoscopy work was therapeutic. The 
     work on thalassemia was clearly therapeutic. It was done for 
     the same reasons that we do amniocentesis, to decide whether 
     or not the pregnancy should continue, and to provide a 
     therapeutic abortion. In fact, I know much of that.
       Hobbins' most recent article, which I believe was December 
     of last year where he had, as I recall, about six or seven 
     patients with sickle cell disease which he was working with. 
     These were all therapeutic. He had tried to make a 
     determination as to what type of hemoglobinopathy, whether it 
     would be homozygous or heterozygous around the 22nd week, and 
     the results were just inconclusive. His conclusion at the end 
     of the article was that at this point we still can't do it. 
     But that was clearly done to be therapeutic. Had he felt that 
     he could have made the determination, he would have offered 
     therapeutic abortion. So I do know that some of the work has 
     been therapeutic.
       Dr. McCarthy. That is correct. I should amend what I said. 
     I think what Mahoney is doing is now tending to move into the 
     preventive therapy and not--so I would like to amend what I 
     said before about therapy, because it was clearly for the 
     purpose of giving parents the option of a therapeutic 
     abortion. But now they hope to move into preventive therapy, 
     which is the sense in which I was using ``therapeutic.''
       Mr. Gaither. Is there an answer to Dr. Henderson's 
     question, though? Do we know whether this technique will 
     enable the researcher to determine the presence of the sickle 
     cell disease?
       Dr. Foster. We never know that until we do the research. I 
     mean, no, I don't think we know it beforehand.
       Mr. Gaither. I think that is kind of a fundamental point 
     here, because implicit in all of these papers, it seems to 
     me, is precisely that, that this technique will enable the 
     discovery of whether or not the disease is present. The 
     question is whether it can be safely done. Now, if that is 
     wrong, my whole reading of all of these papers is very much 
     mistaken. I think it is a very fundamental point.
       Either we are dealing with something that we know can help, 
     and the question is whether it is safe, or we are dealing 
     with something that we don't know much about.
       Dr. Henderson. I am puzzled by your statement that the 
     sickle cell trait is not identifiable before the 30th week. 
     This is what is concerning me at the moment. And if it isn't 
     identifiable before the 30th week, because you do have fetal 
     hemoglobin present, I am not quite sure where this technique 
     leads. I think this is information which we do have a 
     reasonable body of knowledge on, do we not?
       Dr. Foster. I don't know. The only thing that I do know is 
     that the struggle has been to try and be able to diagnose 
     sickle cell--homozygous sickle cell disease at a point at 
     which therapeutic abortion could be offered. Right now we 
     don't have that capability, and it was my understanding that 
     one of the thrusts of this research proposal was to help to 
     try and find that capability.
       I would certainly think that this is an issue that again 
     could be raised with the team, the basic research team who 
     conducted the site visit. I think that these might be some 
     issues that Jim and the staff might wish to bring up.
       Mr. Halpern. Dr. Henderson, it might be helpful.

  Mr. NICKLES. Mr. President, we have the nominee saying a week ago 
Friday he performed less than 12 abortions. On the ``Nightline'' show, 
Dr. Foster said he did 39. Now we have the AP report saying that other 
physicians said he did many more than that in the years prior.
  We have a transcript of a meeting where he said he did about 700 
amniocentesis and therapeutic abortions. There are a lot of 
inconsistencies.
  Again, I say, this nominee should be withdrawn or he should withdraw 
himself because of these inconsistencies, because I think there has 
been a deliberate attempt to mislead Congress.
  Finally, I will say a couple of other things. Dr. Foster's 
credibility has been called into question, not only because of his 
inconsistent statements about abortion, but also because of other 
public statements. For example, during the same ``Nightline'' 
appearance, Dr. Foster said,

       We have a responsibility in training residents to maintain 
     our accreditation, a very 
     [[Page S2490]] difficult job. I maintained an accredited 
     residence program for 17 years.

  But as today's Washington Times reports, the obstetrics residency 
program at Meharry Medical College lost accreditation in May 1990 when 
Dr. Foster was department chairman.
  I watched a tape of that program, and I heard him say he maintained 
accreditation for 17 years. He kind of forgot to say that it lost 
accreditation when he was department chairman. Maybe he just forgot to 
say that. I do not know why it lost accreditation. I have heard, but I 
am not even going to mention that. I am not even faulting him for that. 
I am just saying his record before the public is misleading because he 
lost accreditation in that program. As a matter of fact, that 
accreditation, according to this article, has not been recovered, 
meaning Meharry Medical College cannot place students in hospital 
residency programs in obstetrics.
  I ask unanimous consent to print the Washington Times article in the 
Record.
  There being no objection, the article was ordered to be printed in 
the Record, as follows:
               [From the Washington Times, Feb. 10, 1995]

                Med School Faltered with Foster at Helm

                            (By Paul Bedard)

       The obstetrics and gynecology residency program at Meharry 
     Medical College in Nashville, Tenn., permanently lost its 
     accreditation when surgeon general nominee Henry W. Foster 
     Jr. ran the department--countering his characterization that 
     he kept it operational.
       Senate critics of President Clinton's nominee said Dr. 
     Foster misled them on his administration of the department 
     and the college and said it was another example of the 
     gynecologist hiding his record, especially on the number of 
     abortions he has performed.
       ``He is not being straightforward with the American people 
     and the administration is trying to cover up,'' said Sen. Dan 
     Coats, Indiana Republican.
       Mr. Coats and other Senate Republicans joined Sen. Don 
     Nickles, Oklahoma Republican, in calling on Mr. Clinton to 
     withdraw the nomination because of the differing accounts by 
     Dr. Foster and the White House on the number of abortions he 
     has done in a 37-year medical career.
       The growing chorus of GOP voices demanding the withdrawal 
     muted the support for Dr. Foster stated yesterday by six 
     Senate Democrats.
       Meanwhile, White House officials vented their frustration 
     with Dr. Foster's inability to settle on a concrete figure on 
     the number of abortions he has performed.
       On the same ``Nightline'' show Wednesday night, the 61-
     year-old former Planned Parenthood board director said he had 
     done 39 abortions since 1973, but he didn't address his 
     eight-year stint as chief of obstetrics and gynecology at 
     John A. Andrew Memorial Hospital at Tuskegee University in 
     Alabama.
       Asked if the White House was satisfied with Dr. Foster's 
     answer that he had performed 39 abortions, White House 
     spokesman Michael McCurry said: ``No, we're not satisfied. We 
     will continue to work with Dr. Foster. Many of the records he 
     described last night are only available to him because he's 
     the only person that can request those records.''
       Dr. Foster had previously said he performed one, then 
     ``fewer than a dozen'' abortions. He also headed a study on 
     an abortion pill that led to 55 more abortions. And he has 
     disavowed an official government transcript in which he 
     indicates he may have done hundreds more abortions.
       Officials at historically black Meharry said that Dr. 
     Foster's obstetrics-gynecology residency program lost 
     accreditation in May 1990 and the withdrawal took place a 
     year later--after Dr. Foster had been promoted to the dean of 
     medicine and vice president of health services.
       Several efforts to restore the accreditation have failed. 
     Without accreditation, medical schools can't place students 
     in hospital residency programs, according to the American 
     Medical Association.
       Meharry spokeswoman Martha Robinson said the program failed 
     because there weren't enough patients to sustain a residency 
     internship. ``It was clearly a numbers problem. It wasn't a 
     quality issue,'' she said.
       Dr. Edward R. Hill, who was vice chairman of Dr. Foster's 
     program from 1982 until it ended in 1991, explained that 
     black patients chose suburban hospitals in the late 1980's. 
     ``We lost a very significant market share among the poor who 
     now had a ticket, Medicaid, to more affluent areas,'' he said 
     in an interview.
       But a prominent Nashville doctor familiar with the program 
     and Dr. Foster said the University of Arkansas-trained 
     physician was a poor administrator.
       ``He's a great idea guy but not with following through or 
     getting the job done,'' said the doctor, who requested 
     anonymity.
       Senate Republicans and a White House team are studying Dr. 
     Foster's management at Meharry, which twice received 
     government financial bailouts while Dr. Foster was associated 
     with the school.
       ``One day after he goes on `Nightline' to brag about 
     running his department we learn it crashed on his watch and 
     he failed to get it accredited. He has a very deep 
     credibility problem,'' said an aide with the Senate 
     Republican Conference.
       Mr. Nickles said that termination of the obstetrics-
     gynecology program clashed with the impression Dr. Foster 
     left ``Nightline'' viewers with when he explained the reason 
     for accepting a grant to do a study on an abortion pill in 
     the early 1980s.
       On that show, Dr. Foster said, ``We have a responsibility 
     in training residents to maintain our accreditation. It's a 
     very difficult job. I maintained an accredited residency 
     program for 17 years [1973 to 1990]. We have a responsibility 
     to teach all residents how to manage the complications of 
     abortion.''
       Dr. Foster's changing stories on the number of abortions he 
     did along with concerns about his management of the Meharry 
     obstetrics-gynecology program sparked moves by Republicans to 
     kill the nomination. Dr. Foster is to replace outspoken 
     former Surgeon General Joycelyn Elders, fired for 
     controversial statements on child masturbation and sexual 
     conduct.
       ``In the wake of Dr. Joycelyn Elders' discordant and failed 
     tenure,
      I believe that America deserves to have a surgeon general 
     capable of inspiring Americans on a broad range of public 
     health issues. Plainly, Dr. Henry Foster's background and 
     the White House's mishandling of his nomination renders 
     him incapable of achieving that goal,'' said Sen. Phil 
     Gramm, Texas Republican.
       ``As a result, I intend to strenuously oppose the 
     confirmation of Dr. Foster to become surgeon general of the 
     United States,'' he said.
       Mr. Coats, a member of the Labor and Human Resources 
     Committee, which will vote on the Foster nomination said, 
     ``There is a litmus test here and it is not abortion. It's 
     the truth.''
       Liberal groups supporting Dr. Foster have charged that the 
     ``radical right'' is using the Foster nomination to push its 
     anti-abortion agenda.
       But Mr. Coats said that Dr. Foster simply hasn't told the 
     truth about his past. ``You make the same accident three or 
     four times and you begin to wonder if it's an accident.''
       After watching the nominee get hit for eight straight days, 
     Senate Democrats finally began to rally behind Mr. Clinton's 
     choice. The president also used a press conference with 
     German Chancellor Helmut Kohl to speak in favor of Dr. 
     Foster.
       ``I think he's a good man, I think he'll be a good surgeon 
     general, and I think that that ought to be the issue,'' he 
     said.
       The president also joined with Dr. Elders in bashing Dr. 
     Foster's opponents as ardent anti-abortion radicals.
       ``Now, I know that those who believe that we should abolish 
     the right to choose and make conduct which is now legal 
     criminal will try to seize upon this nomination to negate the 
     work of a man's life and define him in cardboard-cutout 
     terms, but I think that is wrong,'' he said.
       Sen. Frank Lautenberg, New Jersey Democrat, said, ``This is 
     a vendetta, this is a witch hunt.''
       A day after giving Dr. Foster a 50-50 chance of winning 
     approval by the Senate, Sen. Barbara Mikulski, Maryland 
     Democrat, said: ``Unfortunately, the White House did not do 
     the best job in putting doctor Foster's nomination forward. 
     Maybe that's the way the White House does such things.''

  Mr. NICKLES. Mr. President, Dr. Foster became dean of Meharry Medical 
College later in 1990. The following year, according to the June 26, 
1991, edition of USA Today, two other residency programs at Meharry 
also lost accredition--pediatrics and surgery. So while he was dean of 
the medical school, they lost pediatrics and surgery accreditation.
  I ask unanimous consent to print the USA Today article in the Record.
  There being no objection, the article was ordered to be printed in 
the Record, as follows:

                    [From USA Today, June 26, 1991]

        Prognosis: Poor--Med School's Critical Role Is in Peril

                           (By Mark Mayfield)

       For 115 years, Meharry Medical College has trained more 
     black doctors than any other school in the nation, earning a 
     reputation for excellence.
       But now Meharry's doctors are facing their toughest case: 
     the school itself.
       Lack of patients at Meharry's modern, 12-story training 
     hospital is jeopardizing the school's medical residency 
     programs.
       And that means trouble for the national health-care system 
     because Meharry is a top provider of doctors for low-income 
     rural areas and medically starved inner cities.
       ``If the Meharrys and other minority medical schools slide 
     into a crisis situation, it will have a serious long-term 
     impact on health care in low-income areas around the 
     country,'' says Thomas W. Chapman, president of Greater 
     Southeast Community Hospital in Washington, D.C.
       ``They play a critical role in continuing to sustain a 
     appropriate levels of health care in low-income 
     communities.''
       This week, Meharry's obstetrics-gynecology residency 
     program loses its accreditation; residents in pediatrics must 
     transfer to a New York hospital to finish their training. 
     [[Page S2491]] The same problem cost Meharry its surgical 
     training program.
       ``When you don't have enough patients, you don't have 
     enough cases and not enough experience for your residents,'' 
     says Dr. Washington Hill, Meharry's chairman of obstetrics 
     and gynecology.
       Loss of the school's teaching hospital programs could limit 
     its ability to attract minorities to medical careers.
       ``When Meharry has a serious problem, that obviously has an 
     impact on the opportunity of black students to go to medical 
     school,'' says David Denton of the Southern Regional 
     Education Board, which has just completed a study of minority 
     medical student education.
       ``In absolute terms, if you don't have residency programs 
     in pediatrics or obstetrics-gynecology, two primary health-
     care fields, * * * it affects the
      whole teaching atmosphere of a medical school.''
       But Denton says the school's overall quality isn't a 
     problem.
       ``People shouldn't confuse the residency problems with the 
     quality of teaching at Meharry. It has been very effective in 
     getting its graduates licensed,'' he says.
       Nearly 40% of the nation's practicing black doctors and 
     dentists are Meharry graduates. Most of them work where 
     doctors are needed the most--poor urban areas and under-
     served rural towns.
       ``Our graduates are working in inner cities, in New York, 
     in downtown Detroit, here in downtown Nashville,'' Hill says. 
     ``Nobody wants to practice in inner cities. But our graduates 
     do.''
       Meharry also has produced four of every 10 black faculty 
     members in the nation's 126 medical schools.
       Until the 1970s, Meharry and Howard University School of 
     Medicine in Washington, D.C., trained nearly 80% of the 
     nation's black doctors. But with desegregation of what were 
     once all-white schools, just 20% of the nation's black 
     doctors now graduate from any one of the four black medical 
     schools.
       Nevertheless, under 7% of all first-year medical students 
     nationally are black, so educators say Meharry gives 
     opportunity to those who would not otherwise have it. More 
     than 50 of the 80 first-year students enrolled at Meharry 
     this year were accepted nowhere else.
       ``We take kids knowing they bring (academic) baggage,'' 
     says Dr. Henry Foster, Meharry's medical school dean. ``We 
     know they can catch up. It's not how they enter that counts, 
     it's how they exit. We'll put our graduates up against 
     anybody.''
       Administrators and students cite a ``cultural sensitivity'' 
     that graduates may not get elsewhere, based partly on the 
     school being located in a poor, mostly black section of north 
     Nashville.''
       ``Being here is like being in the giant arms of a loving 
     mother,'' says fourth-year student Andi Coleman, 28, of 
     Greenville, Miss. ``Meharry * * * sends its students out to 
     take care of the poor, of the homeless. There is a warmth 
     here you don't find in other programs.''
       Says Dr. David Satcher, Meharry's president: ``African-
     Americans face a chronic health problem when you look at 
     life-expectancy rates, infant mortality, death rates from 
     treatable health problems. Meharry is not just a black 
     institution. It's the leading hospital for the care of the 
     poor and indigent. In all of our history, we have been 
     involved with people who are disproportionately poor.''
       Meharry's patient shortage stems from a combination of 
     politics, tough competition for patients in one of the 
     nation's best medically served cities and financial woes 
     inherent to black colleges.
       Nashville, with 510,000 residents, has one of the highest 
     per-capita number of hospital beds: 6,000 in 17 hospitals. It 
     is home to the largest private hospital corporation in the 
     nation, HCA, and Vanderbilt University Medical Center, which 
     employs 10,000 people.
       To solve Meharry's residency problem, administrators have 
     proposed merging two hospitals--Meharry-Hubbard, where most 
     patients are black, and Metro General, a dilapidated downtown 
     hospital where most patients are white.
       Meharry-Hubbard, with 235 beds, rarely has more than 100 
     patients at a time. ``We have a relatively modern, empty 
     plant,'' says Dr. Rupert Francis, chairman of family and 
     preventive medicine. ``We have to get patients back.''
       The 200-bed Metro General also rarely has more than half 
     its beds filled.
       A merger ``will benefit people who are using a very 
     antiquated facility, and it will provide more patients in 
     which to train medical students,'' Hill says.
       Among those supporting the merge is Vanderbilt, which now 
     provides most of the doctors at Metro General.
       But Nashville's Metro Board of Hospitals, in a 4-2 vote, 
     rejected the merger in February, citing economic reasons.
       ``Some of us call (the vote) racism. The more dignified way 
     is to call it Southern politics,'' Francis says.
       Meharry administrators are confident they'll get the merger 
     and re-establish accreditation for residency programs.
       ``Every hospital located in a low-income community is 
     having a problem,'' Satcher says. ``If you're in that 
     business, you take a beating. You're punished for your 
     commitment. We'll struggle to hold on, until one's ability to 
     pay does not control access to health care in this country.''
       Says Dr. Tim Holcomb, a white Meharry resident in family 
     medicine: ``We have an emphasis on care for the poor. If I 
     went to a big-city type of residency, I'd see sniffles and 
     colds. Here, I see people who haven't seen a doctor in 20 
     years. I have absolutely no regrets coming here.''

  Mr. NICKLES. Mr. President, in my opinion, this raises further 
questions concerning Dr. Foster's credibility. On ``Nightline,'' he 
presented himself as someone who had maintained accreditation at 
Meharry obstetrics residency program. He neglected to mention that he 
was department chairman when that accreditation was lost.
  In my opinion, this nomination should not go forward. Some people 
say, ``Let's wait until we have a hearing and get all the facts out.'' 
But these are statements that came from Dr. Foster himself. This 
statement came from Dr. Foster himself before a committee. It directly 
contradicts the statement he made on ''Nightline.'' The ``Nightline'' 
statement directly contradicts a statement that he made and gave to the 
press, which I inserted in the Record, that he gave a week ago. Dr. 
Foster's statements are totally inconsistent. They have been 
misleading. His statement about the accreditation of Meharry was 
misleading.
  So, Mr. President, I do reluctantly--I do not do this often--but 
reluctantly, I urge Dr. Foster to withdraw his name from consideration 
or urge the President to withdraw his name from consideration to be the 
next U.S. Surgeon General.
  Mr. President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. DASCHLE. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.

                          ____________________