[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.
____________________