April 20, 2006
COUNCIL MEMBERS PRESENT
Edmund Pellegrino, M.D., Chairman
Floyd E. Bloom, M.D.
Scripps Research Institute
Nicholas Eberstadt, Ph.D.
American Enterprise Insitute
Daniel W. Foster, M.D.
University of Texas, Southwestern Medical School
Michael S. Gazzaniga, Ph.D.
P. George, D.Phil., J.D.
William B. Hurlbut, M.D.
Leon. R. Kass, M.D.
University of Chicago
Peter A. Lawler, Ph.D.
Johns Hopkins University School of Medicine
Gilbert C. Meilaender,
Diana J. Schaub, Ph.D.
CHAIRMAN PELLEGRINO: Welcome to the 24th
meeting of the President's Council. We're delighted to have
you here, and I want to welcome members of the public as well,
particularly Rachel Fink from Mount Holyoke and her students.
Welcome. It's good to have you with us.
I want to recognize officially the
presence of Dr. Dan Davis, the Council's Executive Director and the
Designated Federal Officer. His presence gives us a legal standing of
some kind. I'm not sure, Dan, just how secure it is, but —
DR. DAVIS: Rather flimsy, I'm sure,
CHAIRMAN PELLEGRINO: Well, it's good
to have you here. Thank you very much.
I also have the great pleasure this
morning to introduce two new members of the Council. In keeping with
our customary approach, we do not give long and lengthy biographical
recitations, but Dr. Bloom, Floyd Bloom, to my right is from
California, and he's Professor Emeritus in the Molecular
Integrative Neuroscience Department of the Scripps Research Institute
and Chairman of Neurome, Incorporated.
I also want to welcome Dr. Nicholas
Eberstadt on my left, of the District of Columbia, who holds the Henry
Wendt Chair in Political Economy at the American Enterprise Institute.
Both of these gentlemen have, as you
would anticipate, impressive curricula. They've contributed to
their fields. We're delighted to have them with us. Their full
resumes you will find on the Council's Website, and I urge you to
look at them and to acquaint yourself with some of their
This morning we will be picking up a new
topic for the Council. This afternoon and tomorrow we will move to a
continuation of the discussion we've been having on children and
children's research. This morning's sessions will focus on the
discussion of organ procurement and transplantation.
SESSION 1: ORGAN PROCUREMENT AND TRANSPLANTATION
And our first speaker will be Robert
Veatch, whose name will be known, I know, to many of you, a colleague
and friend of mine, and again, we will keep our introduction extremely
brief. So brief that I will give you only his present title: Kennedy
Institute of Ethics and Department of Philosophy at Georgetown, as
well, who has had a long and very distinguished experience in the field
of organ donation.
DR. VEATCH: Thank you very much.
It's my assigned task to introduce
and provide an overview of some of the ethical issues in organ
transplantation. The subject of organ transplantation ethics divides
very nicely into two major categories: the ethics of the allocation of
organs and the ethics of procurement.
The allocation issues are relatively well
settled today, and I will say very little about them, spending most of
my time on the procurement topic. Legally and morally in the United
States, when it comes to allocation, there is a formal commitment to
simultaneously consider the moral duty of maximizing benefit from the
organ system and allocating organs fairly.
The UNOS Ethics Committee, in fact, has
adopted a position of requiring that these be given equal
There's one new controversy
that's worth mentioning before we turn to the subject of
procurement. Increasingly, the Web has begun to play a role in
allocation issues. There are a number of Websites. I provide here in
this slide the front page of one of these Websites called
matchingdonors.com. It is a device where people needing organs are
allowed to register and make their case for a donation of an organ.
You can see that there's a kind of
commercial overlay, free air fares available for all matchingdonors.com
patients and donors. In this Website, there is a listing of the
various people who are seeking organs for procurement. For a rather
substantial fee, people are allowed to make their case for a donation.
This is an example of such a site. A picture is provided together with
a rather attractive slogan, "I want my dad back."
You can see in the text — sorry —
starting down here, "I am writing this on behalf of my very dear
father. It has been over three years on dialysis for my dad now."
Further down in the text, "my
children in the picture want their Papa back." Down in the next
paragraph, "ironically I have worked as a transplant nurse for
over ten years and have helped hundreds of people of all ages get their
life saving kidney transplant."
The issue raised by this kind of a site
is whether the private communication, a Wild West of the Web, makes
organ procurement unseemly. I must say because my name is somehow
associated with transplant, I was solicited by this Website wanting to
know if I would like to advertise for patients for me to do transplants
on patients on this site.
I indicated that since I'm not a
surgeon I probably should not advertise for patients in the way they
suggested. This, combined with the fees involved, raises questions
about whether these Website are distorting the allocation process.
If you ask the question how does one
obtain organs, through this Website, we're either getting
altruistic, nondirected stranger donations that already would have
occurred, and they're being diverted to the people who can make
their best case, or what may turn out to be more likely, we're
recruiting new donors who had not otherwise considered donating to
There are issues here of whether the fair allocation system is
being circumvented. Notice that it was a transplant nurse who had
the savvy, the knowledge of this site to make the pitch. It takes
someone with knowledge of computers and Websites, as well as the
funds to make this kind of appeal.
UNOS has said that it will not explicitly
oppose this kind of recruitment. I think the question is whether the
government ought to be concerned about the distortion of the allocation
formula as a result of these devices.
The allocation formula is a very
sophisticated, well worked out device that considers many complex
factors, and this may end up short circuiting some of that allocation
Let me turn to organ procurement where,
as I've said, I think most of the action will be with regard to the
ethics of transplant. The story is rather well know. We have seen
over the last ten or 15 years a nice, slow, steady increase in the
number of donors that we have obtained annually.
We have, however, seen a dramatic rise in
the listing of persons for organs, and it's clear that the
situation is getting worse and worse. The result is a steady increase
in waiting time so that now the mean waiting time is up around 1,100
The implications of all of this is that
in the last decade, 59,000 Americans have died waiting on the waiting
list for an organ transplant. At the same time, there are
approximately 60,000 cases where there has been a potentially medically
suitable donor that has been lost through failure to obtain the consent
and obtain the organs in a timely fashion.
So that even at the rate of one organ per
donor, we would have been able to provide transplants for those
59,000. Not all of them obviously would have survived with a
transplant, but we're talking about a substantial number of people
who are dying for lack of a organ.
To make the story more complicated, many people have no principled
objection to having their organs procured following their death,
but they've simply never made the commitment. It's a hard
subject to think about, and many people don't even write economic
wills. This is not a high priority for many people.
So that we've got a situation where
many lives are hanging in the balance, and yet there is no strong
motivating force to get people to donate.
Furthermore, if someone dies and is a
suitable donor, if that individual has not expressed a commitment to
donation, there is a resistance among the family for making the
commitment to donate the organ.
Realizing that the situation is getting
progressively worse, there is increasing attention to what I think here
in the Washington area it's appropriate to use the local jargon.
So I will refer to it as the "nuclear option." The nuclear
option would be to abandon the donation model that our country has been
committed to since the 1980s and go to something that is sometimes
boldly called "organ conscription." That's the language
that Aaron Spital, a well known physician in the field of transplant is
It's really just the old organ
salvaging scheme in the late 1960s and early '70s. We talked about
routine salvaging of organs. That is a policy where organs would be
routinely procured unless someone registered an objection.
Now, there's an empirical debate
still about whether this would increase the organ supply. There's
some reason to fear that routine salvaging would produce a backlash and
some people would refuse to donate who otherwise might be willing to,
but I think it's plausible based on experience in other countries
that a conscription model would, in fact, increase the supply.
The moral issue is whether we as a nation
are ready morally to abandon the individualism that has characterized
this country. There are basically two ways you can think about the
relationship of the individual and the state, and some nations have
chosen to view the individual as a source of organs unless an objection
In general, the Catholic countries of
Southern Europe, the socialist Scandinavian countries, and some Asian
countries have gone to a model that legally authorizes procurement
without an explicit consent, usually with an opt out provision for
those to register their objection if they strongly object.
The alternative is the donation model,
which is adopted in the Anglo-Saxon countries of Germany, the
Netherlands, Great Britain, the United States, Canada, where we would
require some explicit donation.
Now, we should recognize that in the U.S.
we're not entirely committed to the priority of the individual. We
have military conscription, and in an area closer to what we're
talking about, we have laws that authorize medical examiner autopsy
without the consent of the deceased or the family.
So with good reason, we have considered a
kind of conscription model, but we're very hesitant to abandon the
language of donation. I am struck by the fact that presumed consent is
the euphemism that is often used for conscription. I'm open to
moral discussion about conscription. I think countries that have
adopted it are acting in good faith, and they're not absolutely
I'm militantly opposed to taking
conscription and applying the euphemism that there is a presumed
consent. The fact of the matter is empirically we know about half the
population would not consent if asked. That's true in countries
around the world.
To claim you can presume consent when we
have empirical evidence that a substantial number of people would not
consent is at best a euphemism and at worse it's a conscious effort
to try to hold onto the consent in donation model when, in fact, there
is no consent and no basis for assuming consent.
In fact, no country in the world actually
has a presumed consent law, and if you're going to talk about this
in any further report, I would urge you to carefully distinguish
between presuming consent and simply biting the bullet and saying
we're going to have a conscription policy.
Let me raise for you six less drastic
options before we contemplate the nuclear option. I raise these
because I think they are issues of current discussion or might force us
to begin thinking about some future alternatives that have not yet hit
I'll say a word about required
response, organ priority, market experiments, living donor exchanges,
what I call the tainted organs problem, and finally, the most
controversial, challenging the dead donor rule. Let me comment about
each of these.
The first of the three that I list here
potentially could double the number of organs. They are all models
that would stimulate people to think about donation, and if they're
willing to donate, to actually make the commitment.
Realistically we could go from roughly 50
percent authorization rates for procurement, I suspect, up to about 75
percent by simply developing mechanisms to encourage people who are in
principle willing to donate to make the commitment and do so without an
The last three options on this list could
produce substantially more organs, somewhere between roughly a 200
percent and a 400 percent increase, and may even approach the number of
organs that we need to stabilize the waiting list or even reduce it.
The question is how far can we work our way down this list without
Let me say a word first about required
response or mandated choice. We now have laws that require requests of
families for potential donors. A hospital is legally obliged to make
the request for a donation.
We're also seen the beginning of the
emergency of state level registries often related to Department of
Motor Vehicles driver's license applications. What is being
discussed and I think is worthy of consideration is going one step
further and actually requiring a response to the donation question, not
requiring that people donate, but simply saying this is a critical life
saving decision and morally you are obliged to think about the problem
to the point that you make a choice either in favor or against
donation. A wise strategy would present a third option so someone
could say they don't know what their decision is, in which case we
would default to familial decisions.
The Department of Motor Vehicles'
mechanism is, I think, a particularly bad way of developing these
registries. There are 50 potential states so that it's all
decentralized. I do almost all of my driving in the State of Virginia,
but I'm not a legal resident of Virginia, and when I tried to
register for the Virginia registry, I was told they didn't want my
organs because I was not a legal resident of Virginia, even though when
I have my accident I will almost certainly end up in a Virginia
Furthermore, the interaction with the
Department of Motor Vehicles is mercifully infrequent. It's only
every five or seven years. So it doesn't give you an opportunity
to change your mind.
Most critically, from my experience, many
of the employees of the Department of Motor Vehicle may not be properly
motivated to initiate a conversation about the ethics of organ
procurement. So I think that's a bad idea.
I would prefer some national registry so
that everybody is in the same database. My personal preference would
be to attach a donation question to the income tax return. It would
reach every adult or almost every adult in the country. The IRS is
pretty good at rules of confidentiality. They could download the
responses, ship them to UNOS, and we'd have a national database
that's renewed every year. So that would be my personal
preference, but some national database seems critical.
I think the Council ought to endorse a
Let me move on to item number two, organ
priority. There are various strategies for rewarding those who have
donated by giving bonus points should those who have donated at some
point need an organ themselves.
We already have bonus points for those
who are living donors of kidneys. So the legal issue have been
settled. This is not an undue inducement. It's not valuable
consideration that is prohibited by law. I would like to see us
explore ways of giving a small token, a bonus point or two for anyone
who has signed a donor cards and had that donor card for, say, two
years. That would avoid people signing the card just at the point they
find out they need an organ for transplant.
I would also like to explore, although it
raises some complex technical issues, whether we could give bonus
points to family members who donate their loved one's organs after
the loved one is deceased. I think the Council ought to endorse in
principle the notion of bonus points and explore ways that the model
can be expanded.
The third possibility is to begin
experiments in market mechanisms. We've got this terrible problem
of a lot of people who in principle are willing to donate, but they
just have never made the donation decision. They haven't taken the
time to think about it.
There are market mechanisms that have
been on the table for many years. They have never been taken terribly
seriously until recently. As those two curves between donation and
listing get further and further apart, there are more serious
Now, there have always been those on the
libertarian side who have thought markets are perfectly legitimate.
They're a reasonable way of increasing the supply of organs. The
resistance has always come from those who I would describe as being on
the left who are concerned that any market, any payment for any step in
the process, whether it's donation or actually providing the organ,
will discriminate against the poor.
The concern for the poor is that offering
financial incentives would be coercive. I'm pretty sure that
coercion is not the right term. Coercion is, if you talk to
philosophers, a term for forcible removal of options.
What we have here is the complex problem
of the ethics of irresistible offers. Offering large financial
incentives to provide organs might turn out to be irresistible in some
cases, particularly for the poor.
Now, the ethical problem for the Council
to deliberate on is whether an irresistible offer is always immoral.
It's pretty clear to me that it's not always immoral. I
consider the invitation to be with you this morning an irresistible
offer. It seemed like a wonderful opportunity, and quite frankly, I
couldn't turn it down, and yet I don't consider any of you
immoral for having made the offer to me.
The real problem with irresistible offers
is exploitation. Exploitation involves a rather complicated set of
issues, and the Council may want to spend some time deliberating on
exactly what constitutes unethical exploitation.
The exploiter needs to be able to offer
some other options in order to exploit the one to whom an offer is
made, but if a kidney or a heart surgeon offers a heart transplant to a
patient telling the patient the alternative is death, that would strike
me as for many people an irresistible offer, and yet a morally
legitimate offer precisely because the surgeon has no alternative to
offer to that individual.
The problem with financial incentives, if they come from the government,
is that the government does have an alternative. It could have
adopted an decent minimum wage or compensation so that no one is
so deprived of the basic necessities that they find such an offer
In 1983, I testified in Congress saying I
opposed markets at the time because of the irresistible offer problem.
I said if in 20 years or so we have not developed ways of responding to
the basic needs of the poorest of our citizens we should revisit this
True to my word, I did revisit it 20
years later, and I've come reluctantly to the conclusion that
it's time that we begin experimenting with very limited market
mechanisms to encourage people to get over the resistance of thinking
about this question.
Now, I've covered the three topics
that I think are relatively noncontroversial and worthy of the
Council's attention. Let me turn to three more in the time that
remains that I think are more complex questions and maybe questions you
have not thought about.
There are many people needing a kidney
who have a willing living donor. Some of those willing living donors
turn out to be incompatible with their planned recipient. So they are
unable to make a living donation, and the recipient has to go on the
waiting list and wait five years for an organ.
Some of these incompatibilities are A-B-O
blood incompatibilities. Some of them are positive antigen
cross-matches. There may be other reasons such as size.
If there is a blood group O potential
family donor with a blood group O recipient, the blood group is not a
problem. There may still be a positive cross-match. We could conclude
that that's an incompatibility and this recipient has to go on the
cadaver waiting list.
But as an alternative, we could have this O donor donate to the
cadaver donor pool and in the process move the recipient up to get
the next negative cross-match blood group O deceased donor.
This turns out to be ethically relatively
noncontroversial. It is a policy we've adopted here in the
Washington area and in a number of other jurisdictions. So the idea of
living donor-cadaver exchanges is something that is very much on the
Let's move to the next problem,
however. There may be a family member willing to donate who is an A or
a B or an AB blood type and their recipient is an O. That is an
incompatible donation, and we could, following the model I just
described, have this AB or A or B donor donate to the cadaver pool and
in exchange for that, the next O blood group patient who donates to the
cadaver pool — sorry — would then have that organ go to this original
recipient who is O.
This presents an interesting ethical
problem. This kind of an exchange has the effect of taking this person
off the cadaver list and producing one more living donor transplant.
So the effect is an overall shortening of the waiting list. That's
a very nice thing.
The problem is every organ that comes
into the list is non-O, and every organ that comes out of the list is
an O organ. O candidates are among those who have the longest waiting
times as we stand today. So it presents a classical Rawlsian fairness
problem. Utilitarians would generally accept the harm to the Os on the
list — they have to wait longer — in order to get the overall benefit
of an overall shortening of the list.
Justice advocates, however, have adopted
the view that this particular kind of an exchange is ethically unfair
even though it is utility maximizing because it discriminates against
Os on the waiting list who are unable to bring a familial donor and
make such an exchange.
Now, having confronted this, there has
been discussion in the literature in the last year or so about ways to
get around this injustice. One possibility would be to get the consent
of the Os on the waiting list to wait a little longer for the good of
the overall community.
Lainie Ross, a physician at the
University of Chicago, and I have both pursued this question, and she
actually was part of a group that did an empirical study that founded
59 percent of the people on the waiting list would have been willing to
wait a bit longer, but 59 percent is really not sufficient to justify
the injustice to those who are already waiting the longest and would
have to wait even longer.
The justification, if there is one, requires going back to our
national commitment to balance utility and justice and explicitly
make a commitment that we will have a slightly unjust allocation
system in order to increase the number of donations.
I, as a way of proposing a temporary
compromise, have urged the Washington Regional Transplant Consortium to
cap the extra wait time for the Os on the list at 30 days predicted
extra wait time.
But another alternative is to reduce the
wait time for the O blood group by following a couple of strategies.
One of them is to further some experiments in incompatible direct
living donor exchange. There are groups, including at Johns Hopkins
and in Japan, that are ignoring this block and are doing this exchange
with some technological ways of attempting to protect the recipient
from the blood incompatibility.
I doubt that that's going to develop
until we develop more technology to overcome that incompatibility. The
strategy that I think is interesting is something I call a voluntary
paired donation. It was the subject of my editorial in the January
American Journal of Transplant. We have many cases, by my
calculation 1,300 cases a year in the United States, of an O donor
family member who's willing to donate with a non-O recipient.
Now, this is a straightforward compatible
donation, and they take place every day in the United States. We never
hear about them because this is blood compatible and presents no
However, looking at it from a systems
point of view, you could describe this as the squandering of the O
organ. We're putting an O organ, a valuable resource, into someone
who doesn't need an O organ. We could find another pair, the pair
I talked about earlier, of a non-O donor with an O recipient and pair
these two people up.
This second group, the second pair, is
not compatible, but what we could do is get this O donor to voluntarily
give his organ to this O recipient in exchange for which the non-O
family donor would give to this organ and that produces one extra
living donation per paired exchange. If there is a potential of 1,300
of these in the United States, that's 1,300 people a year of O
blood type who could be removed from the cadaveric wait list. The
result would be two compatible transplants rather than one.
Now, people like Frank Delmonico will
claim who as an O blood type donor would go through this when they
could just give the organ to their spouse or their loved one. My
suggestion is that there are advantages all around, and that rational
people when they think about it will see the wisdom of this not only in
terms of contributing to the community. That's obvious.
It's also obvious that this person
gains because he gets a living organ rather than a cadaveric organ.
What may not be obvious is that this
individual here can also gain. He can gain by getting a younger donor,
a donor with better kidney function or a better HLA match. So it's
not just an appeal to the altruism of this pair. It may be in most of
the cases of the 1,300 possible that we could arrange this scheme so
that it is simultaneously in the interest of both of these recipients
to be involved.
I think the Council should endorse UNOS
development of this voluntary living donor matching program.
Let me move on to still another, the
fifth of the schemes I wanted to mention to you, the scheme that falls
under the general category of medically suitable expanded criteria.
Some have suggested that there are many organs out there that are
classified as medically unsuitable that, in fact, could be procured.
Approximately three-fourths of all referrals to OPOs for potential
donors are classified as medically unsuitable for one of two reasons.
The donor is believed to have some infectious disease, some disease
that might be transmitted or — and this is kind of embarrassing — it
turns out the donor is not yet dead.
We get referrals for organ donation, and
when our team goes in and looks at the donor, it turns out the donor
isn't brain dead, may be very close to being brain dead, but not
brain dead. So in order to avoid embarrassing the physician who
referred that patient, we use the euphemism of saying that donor is
medically unsuitable. The reason he's medically unsuitable is not
that he's unhealthy. It's that he's not dead yet, and we
have a policy called the dead donor rule that we don't take organs
from donors who are not deceased.
For example, we get referrals of patients
who have high risk lifestyles, IV drug users or gay lifestyle persons,
and historically we rejected those donors right off the top on the
grounds that even if they test negative for HIV, they may not have
seroconverted and there is a risk of transmission.
Now, the risk is very small, but it's
real. We have begun asking the question of those on the waiting list:
if such a potential donor became available, would you be willing to
take that risk and get an organ now rather than waiting until your turn
comes up for an organ without this risk?
Now, some people on the waiting list are
near death. So, in effect, the choice being presented is would you
rather die or receive an organ that tests negative, but poses some HIV
Surgeons don't like to think these
thoughts because it runs some risk of putting HIV into a patient
without HIV, but we are now coding the waiting list so that people who
are willing to consider such organs would have an opportunity to do so.
To stretch your thinking, consider that
we get an organ that tests positive from a deceased potential donor.
We by policy have HIV positive persons on the wait list for
transplant. Could we even take the next step of offering a known HIV
positive organ to an HIV positive recipient, explaining that
there's a risk of transmitting maybe a different strain of the
virus and so forth, but could we make that offer recognizing people
would have the right to decline if they didn't want it.
And if you followed that step in this
progression, think of the case of an HIV negative person on the wait
list in liver failure, Status I, has a week to live, isn't getting
an organ. Do we dare ask the question of whether that person would be
willing to take the HIV positive organ, perfused as well as possible,
but clearly not being able to establish that it's HIV free, and put
that intentionally into a near death HIV negative recipient?
I think the Council should endorse coding
of the wait list so that we have an indication of which of these
tainted organs persons are willing to accept.
It turns out to be a problem not just for
kidney or not just for livers and hearts, but for kidneys as well.
We're increasingly realizing that kidney transplant is a lifesaving
intervention. The deaths per thousand for patients on the wait list
you can see is about 50 percent higher than for persons getting a
transplant. So even for kidney this is a potentially lifesaving
I have one last suggestion. If this
isn't controversial enough to stimulate discussion among the
Council, let me move to my sixth and final suggestion.
Many people, thousands of people each
year, are medically unsuitable because the potential donor is not
dead. Now, some of these people are candidates for a planned cardiac
arrest. That is a decision to withdraw life support because the
individual, even though he's not dead, may be permanently comatose,
and the person could become a donor after cardiac death. That's
being done here in Washington. Ten percent of our donors are donations
after planned cardiac death.
The more controversial and interesting
problem is whether we as a nation should consider donation without
brain death or cardiac death, that is, people who are legally today
alive. To use another language, can we make exceptions to the dead
In particular, there is beginning to be
active discussion about procuring organs from those who are permanently
comatose or permanently vegetative, but not legally dead by whole brain
Now, it turns out that there are two
different strategies one might use. One might keep the existing
definition of death and legislate exceptions to the dead donor rule,
saying that you can't procure an organ from somebody unless
they're dead, unless they are permanently comatose or permanently
vegetative, and of course have consented to the procurement in advance.
Only explicit donors would have their
organs procured under this scheme. That's one possibility. The
other possibility is to further amend the definition of death to move
to what's called a higher brain definition that would call people
dead in our nation who have not literally lost every function of the
As far as I know, no commentators have today that are commenting
on death today really literally believe in a whole brain definition
of death. It means every last function, every reflex through the
brain stem has to be gone before death is pronounced.
If you read the literature, even the
defenders of the present law acknowledge that there have to be
exceptions for what one person has called an insignificant nest of
So we could shift to a new definition of
death that would classify some of these permanently comatose persons as
dead. In fact, a large group of scholars now in rejecting a whole
brain definition has either said go back to a cardiac definition and
then write in some exceptions to the dead donor rule or, alternatively,
go to a higher brain definition where some of these patients would be
legally classified as dead.
The literature among the specialists in
the field suggests that this is a plausible option, but would the
people, the ordinary citizen, accept it? Laura Siminoff, Stewart
Youngner, and their group at Case Western Reserve has recently
conducted a study looking at the opinions of ordinary citizens in the
State of Ohio. The results are really quite provocative.
They studied 1,351 citizens, ordinary people through polling mechanisms.
These are top flight, sophisticated, empirical scientists. They
presented three scenarios, pretesting to make sure that the ordinary
citizen understood the scenario, one involving whole brain dead
persons, people legally dead today in Ohio and every other state
in the Union; a second scenario involving a permanently comatose
patient who is not legally brain dead; and a third scenario involving
a permanent vegetative state patient like Karen Quinlan or Terri
Schiavo, who obviously is not legally dead today.
In their study they asked: would you consider each of these three
patients dead? For the whole brain case, 1,164 said they're
dead. That's 86 percent. That more or less squares with our
knowledge that 10 or 15 percent of the population now have not bought
brain-oriented death pronouncement.
However, what they also found was 57 percent considered the person
in permanent coma to be dead, and 34 percent considered the vegetative
state person dead. Well, so far that more or less reflects public
opinion about brain death, with almost everybody accepting whole
brain and lesser percentages accepting these other options.
They then asked the question: would you
procure organs from these three cases? And as you can see, almost
everybody who thinks the person is dead ends up favoring organ
procurement. There are a handful of people here who think the patient
is dead but wouldn't favor procurement for whatever religious or
philosophical reasons, and this holds true right across. They're
almost identical responses.
Now, here is where it gets interesting.
They then went to those who said these patients were alive and asked
even though they're alive, would you procure organs, and you see
that there is another group of people, ordinary citizens who don't
have the sophisticated linguistic analysis to sort this out. They say
these people are alive, but it's okay to procure their organs.
Now, if you were to add those two groups
together, you get in the case of brain death 93 percent who say
it's okay to procure organs. In the case of permanent coma, you
get one way or another 74 percent who would procure organs, and even in
the case of permanent vegetative state, you get 55 percent who would
I suggest that it's time to consider
the enormous lifesaving potential of opening the question about going
to a higher brain definition of death or, alternatively, making
exceptions to the dead donor rule.
The majority of ordinary citizens seem
already to be in favor at least in the Midwestern State of Ohio.
Let me quickly summarize and I'll be
done. Six schemes that I mentioned, each of which leads me to make a
recommendation to you folks. I think the Council should endorse a
national registry. I think the Council should endorse bonus points for
those who have donated; should endorse limited market experiments to
sort out whether, in fact, this would get people over the resistance to
being willing to donate.
And finally, continuing the summary, I
believe the Council should endorse UNOS development of a living donor
matching program, such as the one I described, particularly the one
with the high payoff, the voluntary exchange from familial O donors.
I think the Council should endorse coding
of the wait list for willingness to accept organs posing some level of
disease risk, and you can talk about how far down that line you want to
go with donors that have either malignancies or viral infectious
And finally, the Council should initiate
a study of organ procurement from those who would be dead by higher
brain definition of death, but are not dead under the current legal
With that, let me stop and I look forward
to any questions or discussion that might result.
Thank you very much.
CHAIRMAN PELLEGRINO: Thank you very
much, Dr. Veatch, for a very direct, clear, highly provocative
presentation of the possibilities and the ethical issues that go with
it. The full range, I suspect, has been presented before us with
I now open up the subject for discussion
by the members of the Council.
DR. FOSTER: Mr. Chairman, I'll ask
the first question.
Dr. Veatch, in reading your paper — and
maybe this is for the next session, and maybe it's covered in one
of the six things — but I had anticipated that you would also address
the issue that you've thought about of direct cash payments for the
donation of organs. Now, if you think that's going to come up in
the next session I'll hold the question, but if it's to the
next session, then I would hope you would also add your comments at
DR. VEATCH: Yes, my understanding is it
will come up in the next session.
I've tried to adopt a very cautious,
middle of the road approach. Historically I resisted all market
mechanisms because of the risk of injustice. I think we've waited
long enough. There are too many people dying. I think it's time
to begin limited experiments with cash payments.
These would be cash payments either for
donation after death, where payment would go to the estate of $1,000 or
so, an enormous money saving proposition. So the money is not an
issue. The issue is the ethics of that.
I think we're ready for a limited
experiment, perhaps in a single state like Pennsylvania that has shown
I'm willing to discuss cash payments
in the matchingdonor.com kind of model for living donation of kidneys.
Iran has adopted that policy and completely removed their waiting list
Now, our nation may not consider Iran as
the model that we want to follow, but it's interesting to see what
the result was at least in that culture and in some of the other
cultures that have gone to cash payment.
I'm nervous about it. I think the
way to go is very limited experiments before we decide whether it
really has discriminatory effects.
DR. FOSTER: Well, I'll probably wait
until the next thing, but I myself am rather skeptical that either any
of these six things alone or combined can really do anything about the
curves that are going on. I mean, if you really want to be serious
about having people waiting for five years for a kidney, which is what
it is in Dallas, and so forth, if you really want to do something about
it, and if you consider premature death, which is not going to happen
with people who have money and so forth, but for the poor it is right
I work in a hospital that takes care of
the poor. We cannot get a liver transplant or a kidney transplant for
many of our people who are new immigrants and so forth and so on. That
to me is a radical problem about fairness and justice and so forth.
I'm not very interested in some of
the concerns of justice that others have brought out in a minor way.
I'm worried about people who every day have no hope of getting a
kidney. It seems to me that one ought to be more radical in terms of
There's a lot of money made in this
business. In Baylor Hospital, which is the biggest private hospital in
Dallas, the most lucrative thing in the hospital is transplantation. I
mean, these are huge amounts of money, and we're arguing about you
use $1,000. I would say, you know, why not — I'm just talking
about dead, you know — just enhancing the likelihood that a family to
get the burial cost, let's say. Maybe it costs $10,000 to bury
somebody. I don't know. It's so tiny that that would likely
do something about it.
Now, I will save the rest of it, but as
a person who works every day facing this problem, I'm not a
transplant surgeon, you know. I mean, it just kills me to have people
just die right in front of me that we could save because we can't
get an organ. And I don't think that even 1,300 changing Os and so
forth is going to do anything about it. I think we have to do
something radical about it.
But I'll wait will the next issue to
comment on that.
DR. VEATCH: My suggestion was that the
combination of these six schemes has the potential of substantially
changing that waiting list, but one of the six items is experiments
One last point. I'm uncomfortable
trying to dress up cash payments by giving them a rationale like paying
burial costs. If you follow through the logic if you pay the burial
cost, the estate that normally pays the burial cost is that much
larger, and it really amounts to a cash payment to the beneficiary of
I would prefer to call it that straight
out rather than — there is a wonderful euphemism in the literature
called rewarded gifting. We will not pay you for your organ, but if
you give us an organ, we will reward you with cash.
I think that comes powerfully close to a
market mechanism, and I would prefer to just say we're paying
people for their organs.
DR. FOSTER: Let me just clarify my
thoughts are not — I read your paper about that. I'm not
interested in hiding this for anything. I'm saying you have to pay
UNOS for these things. You know, they cost; you know, different places
of the country you pay for these organs. I simply say we're paying
like everything else we do in the country for something at what
it's worth and just call it that. I'm not going to try to put
it into a euphemism. I didn't imply that at all.
I'm just straight up saying this is a
matter of solving a problem with money, and it will save money in the
long run, apart from the humanitarian thing. So I didn't want to
get confused about trying to — I'm not an ethicist. So I'm
not trying to hide my thoughts there.
CHAIRMAN PELLEGRINO: I have Dr.
Meilaender and then Dr. Eberstadt.
DR. MEILAENDER: I want to try to ask a
couple of questions that sort of move behind where you began, if I
could because I almost feel as if I were entering the discussion too
far along for me at least to think it through. Because there just seem
to be some issues that need sorting out that are kind of presupposed
For instance, a couple of times along the
way you used language about encouraging people to overcome resistance
to organ donation, but I need to know something more about the nature
of the resistance in order to know whether I want to encourage them to
overcome it or whether encouraging them to overcome it would be
corrupting them in some way.
I mean if it's just selfishment,
that's one kind of resistance, but there may be other harder to
articulate sorts of resistance, and so I'd like just to hear you
reflect just a little bit on that.
A second thing. You started with the
nuclear option, as you called it, of conscription and then moved to
some less drastic possibilities, but how exactly did you rank those
lexically because several of the less drastic possibilities seemed more
nuclear than conscription to me. Challenging the dead donor rule, for
So I mean, I just don't understand
quite how that went.
And then third, and maybe most hard to
reflect on and yet important, way back there somewhere underlying where
you started are just questions about sort of what is an organ and what
is a body and how are they related to each other, and is there some
reason why organs shouldn't be for sale, for instance? I mean, not
everything is for sale. How do I know?
I think public offices should not be for
sale, and if we try to explain that, we have to think about what it is
and so froth. How do I know whether an organ is the sort of thing that
should be for sale unless I think about kind of what it is in relation
to a body?
Those are three examples of questions
that seem to me sort of that come before where you started us, and
I'd like to hear you just — and I know we don't have a lot of
time — but just say a little bit about them if you would.
DR. VEATCH: Yes. In some ways my
response to your third point is tied up with my response to your first,
your questions about my reference to encouraging overcoming of
Let me make a distinction between
resistance to thinking about the question of donation and resistance to
donating. I have enormous respect for someone who has thought through
these issues and has decided that it's not appropriate to donate.
I'm more uncomfortable with the psychology of someone who says,
"Well, this is an unpleasant thought about my distant future or my
death, and it's just not something I want to think about right
I am committed to the view that each of
us owes to our fellow members of the moral community at least enough to
think about this question. So when I talk about encouraging overcoming
of resistance, my main focus in on about the 25 percent or so of
potential medically suitable organs from people who in principle
don't object to having their organs procured, but have never gone
Lots of those organs are lost today
because people have not thought about the question. I believe that
we're at a point where using small incentives like bonus points or
even small payments to think about that question is not only morally
legitimate, but morally imperative today, as long as we're going to
stay in the donation model.
If we go to the conscription model, then
the problem goes away. I'm sufficiently committed to the donation
model, the priority of the decision of the individual, that I don't
want to take organs unless there is a gift of the organ.
But at the same time I think there is a
moral obligation on members of the moral community to have thought
about this problem and come to some conclusion. The incentives that I
have suggested are designed at least in part not to buy the organs but
to stimulate people to think about whether they're willing to make
I suggested that conscription was the
nuclear option in large part because I think it requires the most
fundamental decision about the nature of the relation of the individual
to the society, and going to conscription or routine salvaging or
what's euphemistically called presumed consent requires a reversal
of our traditional affirmation of the priority of the individual.
All of the six items I mention are less
drastic in that sense, and some that sound most drastic, like procuring
of tainted organs and changing the definition of death, I think are
defensible on their own regardless of the implications for organ
I think people should have a right to
choose to be alive with a tainted organ rather than dead without one.
I think people should be allowed to choose a certain range of
definitions of death based on their religious and philosophical belief
systems. I've held that for 30 years, well before anybody ever
thought about this definition of death issue in the context of organ
CHAIRMAN PELLEGRINO: I have four members
of the Council who wish to comment, and it constrains me to make the
comment also that the time is limited. So if you can make it as
concrete as possible it will be helpful.
I have Dr. Eberstadt and then Dr.
Hurlbut, then Dr. Gomez-Lobo, and then Dr. McHugh.
DR. EBERSTADT: Professor Veatch, what I
think will be a quick question about your own thinking on financial
incentives and organ procurement, I read your very interesting paper,
and if I understand it correctly, your own thinking has been moved
towards reconsideration due in part or largely by your judgment about
the condition of the poor in the United States and what you see as our
government's failure to deal with poverty in the U.S.
As it happens I'm doing a monograph
right now on the poverty rate in the U.S., which I believe is an
absolutely dreadful mismeasure of material poverty, and I try to make
the case in this monograph that since 1983, when you testified before
Congress, the material condition of the U.S. poor has actually
dramatically increased in many different ways.
My monograph may or may not be convincing
to any reader, but if we hypothesize that you were convinced by this
set of arguments I made, would that be enough to make you reconsider
your reconsideration of financial incentives?
DR. VEATCH: I've said all along that
financial incentives per se are not the problem. The problem is
developing financial incentives in a social context where some would be
exploited because of their desperate poverty.
So if you tell me that you hypothesize
this society where that dreadful level of poverty does not exist, where
the exploitation would not occur because of that, then I'm much
more open to financial payments than I otherwise would be.
I focus on this analysis. I assume
libertarians have always been satisfied with market mechanisms. The
political problem with markets has been the resistance from the
egalitarian left, and I've said I was part of that egalitarian left
leaning portion of the population, but we've waited long enough
with the number of lives that are at stake, and we ought to cautiously
CHAIRMAN PELLEGRINO: Dr. Hurlbut.
DR. HURLBUT: Well, picking up on that
theme from a different angle, reading your paper and especially in the
phrase where you speak of the poor being allowed to market the one
valuable commodity they possess, it struck me as raising some
fundamental questions that maybe we get on the table first.
First of all, it did strike me that I
teach in a university and many of my students feel very poor. So it
raises an interesting question of who should be allowed to donate a
kidney in the first place.
You mentioned that driver's license
is the moment, and they do that in California, too, where you can
indicate a willingness to donate. They give licenses at 16. Is that
too young for somebody to decide?
Let me give you a series of questions,
and you can answer them all at once. Is that too young to decide?
I noticed in the picture that you gave us
in the beginning Jackie Stupani and Mary Christiansen. If I understood
it right, the younger woman donated to the older woman; is that right,
in this picture?
DR. VEATCH: I'm not sure which.
DR. HURLBUT: The online thing where the
64 year old grandmother —
DR. VEATCH: I'm not sure what the
answer is to your question.
DR. HURLBUT: Okay. Well, here's the
series of little questions. What's the average age of death
What's the average age of a donor?
And what's the estimated increase in
life span after a donation?
And do you have a feeling for whether or
not there's an age where somebody shouldn't donate? In other
words, there are risks associated with donation. Let's not ignore
that fact, and there are idealisms involved that may be
disproporationate, too. There are very positive idealisms obviously
also, but the question is: is there something in the way of even just
getting down to the equation here without the deep, deep questions that
Gil was raising? Is there something a little sort of troubling about
the idea of young people donating for old people, for example?
That's the kind of category of
question I want to address.
DR. VEATCH: I think we need to make a
distinction between donation after death and living donation. For
living donation, surely the consent has to be limited to competent
adults, and there needs to be psychological work-up of the donor to
make sure they're competent. A 16 year old would not normally
qualify for living donation.
For donation after death, the
driver's license checkoff, I am not uncomfortable with someone as
young as 16 making that choice. We could adopt a policy that you
can't become an organ donor until you're 18 or 21. By
definition, the risks to the donor are not medical and direct. If
there's a risk to the donor at all, it is psychological and
I'm quite comfortable with a 16 year
old becoming a donor on a driver's license. That doesn't
With regard to living donation, I am very
hesitant to impose limits on bonded donors. By bonded donors, I mean
someone with a preexisting relationship with the recipient like a
spouse. It makes me very uncomfortable to envision, say, a spouse who
knows that he or she has the lifesaving potential for dealing with a
medical problem of a loved one and to have some review committee in the
transplant world review the case and decide the donation is not
acceptable because it's too risky. I find that very troublesome.
I'm a member of the Living Donor Task
Force and strongly oppose such limits.
DR. HURLBUT: Do you have the statistics
for the questions that I asked about the average age and so forth?
DR. VEATCH: Those numbers are
available. I don't have them off the top of my head.
I don't see difficulty with donors of
too old an age once they qualify to be recipients of a transplant,
certainly not in terms of cadaveric donation, but even in terms of
living donation. Frankly, it doesn't trouble me. I would be
interested in hearing arguments to the contrary.
CHAIRMAN PELLEGRINO: I have Dr. Gómez-Lobo, and
let me give the list please because the time is, again, going and I
need to warn you about that. Dr. McHugh, Dr. Kass, and then Dr.
Lawler. So that everyone may have a chance to comment, brevity would
be most helpful as well as virtuous.
DR.GÓMEZ-LOBO: I'll try to follow
the path of virtue myself.
Let me go to the point that mostly
worries me as a member of a Bioethics Council, as someone who is
expected to give advice on ethics, and I think the most troubling part
for me is the role of the empirical study in ethical thinking.
I have in front of me, of course, the
results of the empirical study of the Ohio citizens. Now, what is the
value of that for the Bioethics Council? The fact that people are
willing to procure organs from people who they think are alive. Now,
one way of viewing that would be to say, now, there's a very
serious corruption here in ethical thinking, if that's what they
Now, what's the solution for that? I
really admire your willingness to go the frankness road and not call,
say, rewarded gifting or compensated gifting "gifting." I
totally agree that one should call that purchasing and selling of
But here we seem to face the idea of
changing the definition of death. I would call it the criteria of
death just to accommodate this possibility. Now, I find that, frankly,
unacceptable. I think that the criteria for death should be
independent of that and that there should be a moral decision affirming
that we should never ever procure organs from people who are alive.
DR. VEATCH: I would agree that it is
never acceptable to change a definition of death just to get organs.
Leon will remember, I'm sure, Hans Jonas suggesting if that's
our strategy, why not define all college students as dead. We'd
get much better organs and solve some other problems along the way.
DR. VEATCH: We can't change the
definition of death for that purpose. I tried to make clear that my
starting point was that the present definition of death is incoherent
as it stands, and there must be a philosophical correction, one that
has been accepted for at least 30 or 40 years by a large number of
theorists, including one of the leading moral theologians of the
Vatican that endorsed a higher brain definition.
Once we have decided that there is a more
philosophically defensible definition of death, the question then
becomes, well, why don't we adopt it and save some lives as a
Typically the answer is, well, it's a
political problem. It won't sell to the ordinary person. The sole
reason I presented the Ohio data was to attempt to speak to the
objection that even though higher brain definition of death is
philosophically defensible, the ordinary citizen won't accept it.
The result seems to be that many ordinary
citizens don't exactly grasp the difference between what it means
to be dead and what it means to be alive. I, frankly, think I could
take the people who indicated in the survey that they were willing to
procure organs from the living and convince them that, in fact, the
reason they believe they could procure the organs was they believe the
person was already dead in the sense of having lost standing as a full
member of the moral community.
So I use the survey merely to offset the
claim that the philosophically defensible proposal is not politically
CHAIRMAN PELLEGRINO: Dr. McHugh.
DR. McHUGH: Thank you, Dr. Veatch, for
But I also have the same sense that Gil
Meilaender has, that there are a very large number of themes underlying
this that relate to issues of resistance and religious matters of
meaning in this process because we don't sell certain kinds of
things to one another and don't make exchanges at that level.
But I have fundamentally a more simple
question to ask of you and of all the people like myself who are
involved in hospital care where we see that the clamor for organs is
far exceeding its supply. And most of these solutions that are
proposed, even the solutions you propose, I don't think are going
to solve that problem.
Dan and I have been looking at the kidney
business since 1955-56, when the first transplants were made, and have
seen the wonderful achievements and progress in science in relationship
to this thing that has happened over 50 years. It began with us with
identical twins and now has come to the place where we're at.
Now, I'm not sure that I want right
now — of course, for individuals I want them, the individuals I know
and I appreciate my patients and the like, I would like them to get
organs when they can, but at the same time, these statistics of showing
this demand, it just says that the science has got to get better, and
the science of xenotransplant, you know, the trajectory from the
beginning at the Brigham with those twins to now, well, where are we
with xenotransplantation? And shouldn't this pressure be the kind
of pressure that we want to be presented, to acknowledge, and say more
investment needs to come into xenotransplant because that's going
to be the solution?
DR. VEATCH: Let me simply say I'm
supportive of experiments in xenotransplant and immunosuppression as
CHAIRMAN PELLEGRINO: Dr. Kass.
DR. KASS: Since time is short I'll
simply just register that I don't think the current criteria of
brain death or whole brain death are incoherent. I think they can be
defended; that there are people writing in the literature. It is too
bad. Perhaps this Council could take up that subject and defend the
understanding of death as the death of the organism as a whole, but you
know I think that we differ. I have just been silent on the subject.
I'm more interested in — and this
will perhaps be taken up more in the next session — your thoughts on
the buying and selling and the market. You say in the paper that there
really is — this i on page 14 — "There has never been any
serious moral problem with permitting financial incentives to nudge
middle and upper class people to think about their willingness to
consent to organ procurement."
In other words, the issue for you has to
do solely with the pressure that this places on the poor. Is it really
true that if there were no poor we would have no concerns about
becoming a society in which organs are bought and sold?
If that's your concern, why don't
you simply say, look, only those people who pay income tax above a
certain sort can enter into the business of buying and selling.
And, on the other hand, if you are now
willing to experiment with markets involving the poor, why aren't
you in favor of letting them get out there in the market and buy and
sell to the highest bidder so that they actually make something from
In other words, isn't there really
something disquieting about entering into a society in which parts of
the body are treated as alienable things, like automobiles and other
disposable goods. If that's not a question for you, I don't
see why you don't find some solution compatible with your worries
about the poor, either to let them get full advantage of their organs
or just keep them out of the market so that they won't be
DR. VEATCH: Let me simply say that,
indeed, I've been troubled by just those questions for a very long
time. I believe what I've endorsed is incentives for thinking
about donation. I'm more comfortable with incentives for thinking
about donation than I am about incentives to actually providing the
organs, but over the years I've been moved by the very serious
problem of the number of people whose life and death hangs in the
CHAIRMAN PELLEGRINO: Dr. Lawler.
DR. LAWLER: I think after listening to
Dan I'm all in favor of more aggressive methods to acquire the
organs of people who are dead in the noncontroversial sense of dead,
but going further than that seems to me to be a huge problem.
The question Bill asks, I think you
answered it too easily. A husband giving an organ to a wife, this is
an act of love. A daughter giving a kidney to a father creeps me out
beyond belief for reasons Bill was trying to call to your attention, I
And then the Website creeped me out
beyond belief for this reason. If you have a market, then you have to
have advertising, and advertising means scaring up kidneys by having
commercials like, "What are you doing at home sitting selfishly
around with two kidneys? You don't really need them."
DR. LAWLER: You know, "what kind of
person are you?" It's not so much the monetary thing that
does bother — it does bother me. I'm not for it, but that in
idealistic young people, 18, 19, we don't have the draft anymore
and they're not going to conscript my organs, but I could volunteer
This seems to me to be quite unreasonable
demand to put on people, right? And so when you create a market, you
then have to stimulate demand and it requires a certain kind of
advertising. In a way, although I would be very concerned about
exploiting the necessity that governs the poor, I might even be more
concerned about exploiting the idealism which governs the rich and
DR. VEATCH: I think those are all valid
concerns. Let me simply note that in terms of volunteering organs,
that's presently legal today and is being done. So all the
questions about the validity of the donation from a young person are
already on the agenda and OPOs and procurement personnel have to screen
nondirected donors to eliminate those who for one reason or another are
not making an adequately competent donation.
Adding money to that mix doesn't
change that issue, although it raises the deeper kinds of concerns that
Dr. Kass was trying to raise.
CHAIRMAN PELLEGRINO: Thank you very
We have reached the end of this first
session. Let me point out that we have two more speakers on the same
subject coming on at 10:45, and therefore beseech the Council to be
back promptly on time because I intend to start promptly on time
because I know you'll want to have questions for the other speakers
(Whereupon, the foregoing matter went off the record at 10:32 a.m. and
went back on the record at 10:47 a.m.)
SESSION 2: ORGAN PROCUREMENT AND TRANSPLANTATION
CHAIRMAN PELLEGRINO: I think we will proceed,
and let me begin with the first speaker for the next session, Dr.
Richard Epstein, who is Director of the Law and Economics Program
at the University of Chicago Law School.
DR. EPSTEIN, could you?
DR. EPSTEIN: How long do you want me to
talk? How long?
CHAIRMAN PELLEGRINO: Half hour.
DR. EPSTEIN: Whatever you say.
CHAIRMAN PELLEGRINO: Well, I'll make
it clear when it's over.
DR. EPSTEIN: Somehow or other I
don't believe that we're —
CHAIRMAN PELLEGRINO: Did you jump to
DR. EPSTEIN: No, I think what I did is I
understand this is a system with strong property rights in time, and
what I will try to do is to respect it.
I should say in one sense I think having
listened to many presentations on this subject, I'm proud to be an
outsider to the so-called transplant community. I think I was brought
here and I think rightly so to express a very deep and abiding
skepticism. Everything that UNOS does, my modest policy recommendation
is that the organization be forthwith abolished and we try to find some
more sensible way in which to deal with organs, but rather than talk
about it at that modest level, let me see if I can figure out a general
way from an approach which involves a mixture of law, economics, and
yes, even moral philosophy to explain what my views are and how one
ought to think about this question.
I think the first thing that one ought to
do in trying to deal with any normative question is to ask yourself a
couple of very simple, descriptive questions, and those are the kinds
of questions which ask you how do we explain what the current situation
And when we're dealing with the organ
situation, there's only one fact that seems to stand out above all
others, and that is the chronic and irreducible shortage of available
organs, particularly kidneys.
We know what the death rates turn out to
be. Everybody is an expert on that. The explanation is why does such
a situation come to arise, and I think the simplest way to put the
explanation is just take the most naive version of supply and demand,
abstract out from every one of the special ethical and moral
considerations that are associated with kidneys, have a negative
sloping demand curve and a positive sloping supply curve, and then
create a situation in which you place artificial restrictions on the
price, in this case trying to restrict it to zero.
And the prediction is whether you're
dealing with widgets or with organs, there will be systematic and
massive shortages that will take place under these circumstances.
Quite simply, you get very low supply at zero price and you get an
immensely high demand, and the function of a price system in this kind
of a universe is to try and figure out how you increase the supply, on
the one hand, and reduce the demand, on the other, so that you get
yourself into some sort of an equilibrium.
And the way in which people have tried to deal with this in many cases
is to ignore this sort of blinding reality and to figure out other
kinds of devices in which you could tweak things here or there in
an effort to try and boost up the supply without trying to change
the price, that is, to work on other kinds of terms. These could
either be moral suasion, which easily turns into coercion. You
could have public campaigns. You could have other kinds of disguised
transactions like barter, which in fact clearly violate the UNOS
guidelines, but everybody tolerates them because nobody wants to
see more unnecessary deaths that take place.
There is a very elaborate understanding
of the way in which when you have regulated prices people try to
circumvent the rules, and so the first thing I would urge upon you when
you start to think about this particular question is do not get
yourselves into the illusion that there is something so unique and
distinctive about the questions of organs or body parts or any form of
transplantation that the general rules of economics do not apply with
respect to this particular situation.
And that, I think, is the descriptive
reality. The question then is how do we start doing this from a
normative framework, and here the way in which Dr. Veatch put the point
last time in the earlier session was, I think, rather misguided, but I
think it represents the dominant thinking on this subject, which is to
postulate that there is some kind of necessary and inevitable tension
between the principles of the maximization of utility, on the one hand,
and principles of justice and fairness, on the other, so that what we
have to do is to constantly figure out ways in which we square the
difference or overcome this thing. We're always working in a world
of two values. We never know how much to weight them, and in the end
what we do is we produce a giant form of stasis in which it turns out
that the shortages cannot be eliminated.
Why is it that I think that this is
wrong? Well, I think the deepest mistake that is made in talking about
transplant as a conceptual matter is the regrettable confusion with
compensation, on the one hand, and coercion, on the other. These two
are treated almost as though they are synonymous, whereas in every
other state of the world what happens is generally speaking
compensation is, in fact, regarded as a way to make social
improvements, on the one hand, without having a class of systematic
losers, on the other.
If, in fact, you decide that every time
you make a system with a compensation component in it that you've
engaged in coercive activity, you make it impossible to have situations
in which you can address imbalances that are created by natural
circumstances through the imposition of this particular kind of
So let me, in order to make this a little
bit clearer, sort of give one the definition that sort of an economic
Kantian, to use that kind of a person, would take in the way in which
you're trying to think about social welfare.
There are, in general, two kinds of
definitions of social welfare that economists and, to a large extent,
lawyers use. Let me mention them both here.
The first of these is something known as Pareto. A pareto efficient
solution is essentially one where you cannot make any person better
off without making some other person worse off. More importantly,
in a world of Pareto thinking, what you're always trying to
do is to create a set of situations in which you move all people
from one state of the world to a superior state of the world, in
which somebody is better off and nobody is worse off, and indeed,
ideally for the most part you would actually like the gains to be
pro rata across all individuals to the extent that you're using
state coercion to achieve that result.
In many cases, the only way in which you
can create Pareto improvements is to allow allocative changes to take
place and then to give cash compensations to the losers to offset
what's going on. Indeed, most people when they start to talk about
Pareto improvements as a criterion of social welfare are somewhat
uneasy about using it in practical circumstances because what happens
is that the condition is so restrictive that if you create a world in
which one person is left the tiniest bit worse off and everybody else
is made largely better off, you're going to veto the transaction
because you have not had a condition of universal improvement.
So what happens is in many cases
economists who are worried about this resort to another definition
involving not actual but hypothetical compensation, and that's
called Calder-Hicks efficiency, and what this means is that you have a
situation where you can move from one state of the world to another
state of the world, where, in fact, the gains to the winners are so
large that you're confident that if compensation could be made, the
winners could pay it. The losers would be happy to receive it, and the
winners would still be better off than they were before.
So that what you do is you have a large
allocative gain measured by subjective satisfactions, and the
possibility of transfer payments, which are not realized because of
practical impediments which would allow you to get to some kind of a
And what I would suggest to you is in thinking about this subject,
the one thing that you have to beware of in this vaunted business
of ethics is a definition of coercion which is so large that it
swamps up all efforts to use compensation mechanism to allow for
allocative improvements, on the one hand, and a fair distribution
of gains, on the other.
Let me give you one illustration from
what was said earlier today about how it is that you can mess this
thing up if you're not careful. We heard about something known as
an irresistible offer, and then we were told it's nice to get
irresistible offers. They're called recruitments.
Why does it turn out that it is somehow
or other a form of coercion in some cases and a form of benefits in the
other? I have to say I don't get it, and let me explain to you why
it is that when you put this in the context of wealth and poverty, what
is often seen as a dangerous and insidious tendency is, in fact,
nothing of the sort.
If, in fact, you accept, which is I think
commonly the case, that there is diminishing margin of utility of
wealth, that is, the richer you get, the less money counts for you, and
you hold out a constant sum of money to a rich person and a poor
person, the rational response will be if you're worried about your
own utility, is that a poor person should be more willing to sell,
ceteris paribus, than a rich person precisely because the money
has a greater change in his life than it does with somebody else.
And so, therefore, what you are calling
in effect a kind of coercive situation that one ought to deplore really
should be understood as an effort of the state to clamp down on a set
of opportunities which should, in fact, be encouraged. Unless you
think that these individuals are incapable of making their own
judgments, at which point you would not allow them to make donations
anymore than you would allow them to make sales, what people are
identifying as a problem is, in fact, a benefit, and the reason why
they are making the mistake is it turns out that they get themselves
into a terrible pickle under these circumstances because they assume
that any kind of a transfer payment involved, not as an economist would
think of it, as a way of equalizing gains, but rather turns out to be
something insidious and to be blocked in itself.
And it's this fundamental moral
framework which leads, I think, to the prohibitions that one sees under
the UNOS setting and which creates such incredible dangers in the
overall operation of the system.
Now, thus far I've been talking about
exchanges and talking about this in a sense of trying to figure out how
everybody can act in a self-interested fashion in order to improve
their lot through a series of voluntary transactions.
There is, however, another problem here
which I think is extremely important, and one has to figure out how to
model that as well. And quite simply the question is: what does one
make of the idea of altruism when it comes to dealing with various
kinds of human transactions?
And looking at this, there is a great
tendency in the world, I think, to dichotomize the concept, and what I
mean by that is we start to divide the world into people who are
egotists, on the one hand, and who are altruists, on the other, and
what we're constantly worried about is the mixes between these two
classes of individuals.
It seems to me that that's a mistake in the way in which we
want to think about the world. Generally it's much more accurate
not to think about two pure ideal contrasting types. You're
usually going to be safer to think about the situation where there
is a continuism of egotism amongst individuals. There are some
people who will be extraordinarily selfish. There will be some
people who will be quite generous. There will be lots of people
who will be in between.
And so then the question is once you
understand that, how do you try to model altruism in a way that does
not make it into a radically discontinuous state from the various sorts
of egotistical behavior, and in dealing with this in the particular
paper that I wrote especially for this occasion, what I did is I gave a
very simple model. For those of you who want it on the papers, I think
on page 11, and you can look at the graph to see the way in which one
ought to think about it, and here's the way you look at it.
Generally speaking, in a world of
egotism, what you will assume is that nobody will make any transaction
which results in a net cost to him or to herself. Those things are
essentially not going to be acceptable because the theory of rational
choice on a radically individualistic model is unless the expected
utility after a transaction nettable risk is positive, you don't
enter into it.
But what I think, in effect, is that that
is clearly wrong. Even if you look at the current lamentable state
with the shortages in question, if you use the rational choice model,
you would come up with the observation that in a world that exists
without any financial compensation, the number of anticipated
transactions is zero. You would be basically at the origin. Nothing
would start to move.
And yet it is incontrovertible that there
is at least some positive response. So how do you try and model that
without giving up all of the sensible stuff about equilibrium theory
that results when you're talking about the usual equation of supply
And the simple response, I think, to
this, which actually I have not been able to find anywhere in the
literature, although I'm not a full-time professional economist, is
to simply take the supply curve and make sure that it intercepts the X
axis at a positive point, and then in effect have it continue to go
down so that the supply will diminish until at the point where the cost
to the individual donor is so large that even the altruist will start
to give up under the transaction.
At this point, what you can then do with
respect to the situation is to figure out what the equilibrium
conditions are going to be on price, on the one hand, on quantity, on
the other, even if you now make no other deviation from the usual
That is, what you say, in effect, is that
when you're dealing with altruists, if you give them a little bit
of compensation, there will be a few more altruists who will come in
there, and it turns out that when you cross the X axis, it's not as
though the world is a discontinuous place. What will happen is that
the altruism will continue to show its effect because the supply curve
will be systematically lower and to the right than will the curve be if
you've got pure egotism.
Once you do that and you assume a
constancy with respect to demand and you then look at the equilibrium
in the two cases, the following observation takes place. Altruism
continues to have desirable social consequences. We don't know its
size or its extent because in equilibrium you will find that there will
be a larger number of organs or, indeed, any other good that will be
transferred, and they will be transferred at a positive price, which is
lower than would take place if, in fact, you had the pure egotistical
So that what happens is if you look at
this, there is no particular reason to think if you have altruism that
somehow or other the use of a market mechanism is going to destroy the
operation in hand.
And here let me point out, which I think is a very important constant
confusion and error which takes place in this literature which states
Richard Titmuss, in his arguments, associated with blood supply,
and the usual argument in these circumstances that we cannot allow
cash transfer payments to take place because what it will do is
it will crowd out the altruists.
Now, what you want to do is to look at
those two curves and understand what is meant and not meant when you
start to deal with the problem of crowding out under these
circumstances. And here the same situation is if you just look at the
standard conventional curve in which it turns out that the supply at
zero is zero and watch that thing go up, every time you raise the price
what you will do is increase the consumer surplus for those people who
would supply it at a lower price.
So, in other words, in an ordinary market
the moment you raise the price to ten, what you do is you eliminate all
of those people who would have supplied the good at five, and you can
argue that that's some kind of a crowding out because it increases
cost, but the central feature in figuring out the social welfare
consequences of this kind of rule is not the size of the transfer
payment. It's the question of the total consumer and producer
surplus that is generated by the transaction.
In other words, if you're thinking about the money going back
and forth between parties, the right way to understand it is as
follows. First you assume that the increased prices is a loss to
the person who pays it, and then you assume that it is a gain to
the person who receives it.
As a general matter, the utility of money
is as a first approximation about the same in both hands. So you
can't figure out that there's any gain or loss from the
On the other hand, what you do is you push yourself back into
equilibrium, and then afterwards if you look at the equilibrium
situation and work out the gains to consumers and producers, it
will be higher if, in fact, the transfer payments are made than
And exactly the same argument applies
when you're dealing with the other supply curve, which crosses the
X axis at a positive point. You raise the price. The equilibrium will
be different by virtue of the altruism, but there's no crowding out
that's taking place. There is simply the payment of a transfer
which doesn't have social consequences plus or minus one way or
another, in exchange for which we get a vast increase in the total
supply, which allows us to bring this particular market back into
So I think that the clear lesson that one
learns from all of this stuff is as follows. There is, in fact, no
particular reason to create any rules that are distinctive to altruists
relative to people who are egotists. The same method of voluntary
exchange will work whether you're dealing with one class of the
population or with the other. It is an empirical question as to how
much altruism there is, and the way in which you can understand that by
looking at the graph is to just ask yourself: are you somebody who
believes that everybody is selfish, at which point that gap is very
narrow, or do you think in the general benevolence of humankind that
the gap is very large?
Frankly, my dear, for the purposes of
social policy, I don't give a damn which way it comes out because
the same intellectual solution applies in both cases. You're going
to get to equilibrium.
If you're asking me as a philosopher
king which I'd rather have, generally speaking, I prefer a world
with a little bit of altruism because you will get a lower price and a
large supply of organs, and on balance, you will have some degree of
reduction with respect to human suffering.
Now, when we take all of this stuff,
let's just look in the framework of the current system at several
of the problems that we're having to deal with to see how it is
that we ought to think about them. Mr. Veatch earlier in the day
started to talk about the question of how it is you start to deal with
organ swaps and those cases when voluntary donations create the risk of
And so what happens is that taking the most dramatic situation,
I'm A, my spouse is B, somebody else has got the reverse situation,
and what we do is we want to flip them over to get two transactions
instead of having none.
I think the first thing that one has to understand is that if
anybody is serious about those wretched definitions of what counts
as valuable considerations in the statute, this is an illegal transaction.
You go back to Roman law. Transformations in barter have always
been regarded as exchanges. They've always been treated as
such under the law. The thought that this is not valuable consideration
is simply a joke to anybody who's serious about what those words
You cannot get a competent lawyer who
will look at this stuff who would not say it's anything other than
an outright evasion of the statute, for which I say amen and thank you
because it's about time that we started to find some ways to get
The more difficult cases are, it turns
out, where you have the O-A kinds of oppositions, where you get one
person who, in effect, will make an A donation in exchange for having a
spouse receive an O donation off the cadaver list.
And here what I want to say is, in
effect, if you're thinking about this in terms of the general
economic theory, you've got to understand, first of all, what the
gains and the losses were. Mr. Veatch was wrong when he said, in
effect, that this is systematically a loss with respect to everybody on
the O list.
And the reason why that is incorrect is you cannot simply look
at the fact that it pushes people down by virtue of somebody getting
up. That is, indeed, a minus. But if you're doing the whole
thing systematically, you also have to take into account that everybody
regardless of their place on the list has a positive probability
of procuring one of these matches, and the right comparison is to
ask whether or not that chance minus the delay is better than stasis,
and almost invariably if you're going to increase output, it
would be very hard to find a set of systematic losers when, in fact,
the rules are perfectly general.
In addition, it seems to me that this model is wrong also if you
take his view of the Rawlsian veils of ignorance, which is very
easy to misapply and was done so in that case. And here I think
that there are a couple ways in which you could start to look at
this thing, and the simplest of them is this.
Let us suppose, in effect, you're playing risk analysis.
Then the first thing you have to do is to say we're doing it
before anybody knows whether they're an O or an A donee. You
just don't know, or an A or an O donor.
And at that particular circumstances, if
you go behind the veil, the big mistake that Rawls made with respect to
his own theory is to assume that people behind the veil of ignorance
would be extremely risk adverse and would only worry about the
condition of the worst off.
In fact, virtually everyone behind the veil of ignorance, even if they
had some degree of risk aversion, would certainly think much more
in terms of social utility in an expected value sense rather than
in terms of this extreme situation.
Indeed, I would argue that the version of Rawlsianism which says
that you look only at the guy at the bottom of the list is a highly
immoral kind of conception, because what you're saying is that
one single individual gets to determine and dictate the social preference
for thousands of individuals.
So that what you really want to do from
behind the veil of ignorance is that you know if you're an A guy
you live, whereas otherwise you die. If you're an O guy, it turns
out you've got this complicated set of choices and you're not
sure whether you're bad or worse off.
Nobody in their right mind under those
circumstances would ever assume that if they didn't know whether
they were O or A, that their anticipated social value would be better
off by blocking these kinds of transactions.
And the second point, again, that one wants to make about all
of this, if you have any moral ambiguity associated with the status
on the O list, what you do is you handle that through the payment
of direct compensation, and so you try to figure out what the utility
loss is, and you give cash, even taxing the As to give it to the
Os so as to make it into an ex post Pareto improvement.
Your last thing that you want to do under these circumstances
is to result in this freezing, and so it goes right back to the
basic intellectual mistake that I talked about at the beginning.
If this group is going to endorse a definition of coercion that
includes compensation, you are bound to have lots of people meet
needless deaths because you will never be able to get yourself into
an optimal form of equilibrium.
Now, the last point that I want to make — and I have about
five minutes, right? I'm pretty precise on this — is
to talk about how we think about directed donations in other situations.
If you recall, when I started at the beginning of the session what
I said was the moment you get yourself a major imbalance in supply
and demand by putting a maximum zero price on anything, you're
going to find all sorts of people who are going to engage in various
efforts of circumvention.
And so don't think about organs.
What I suggest you do is that you just look at the headline on USA
Today, and it said that higher gas prices lead to lower demand. I
mean, the people do respond to incentives one way or another. It's
going to happen here.
And if you block the obvious thing, which
is paying price, people are going to go to more costly ways in an
effort to bridge for themselves in more egotistical ways that markets
would otherwise have in an effort to get to the head, and that gets you
to directed donations in one way or another.
And so what happens is people will start
to advertise, and they will start to put themselves up on the Web as
individuals, and they'll have their children, right, and all of
these piteous and horrible things. And I say God bless them.
They're doing exactly the right thing, and anyone who wants to stop
that is to my mind being quite monstrous from a moral point of view
given the enormity of the harm that's associated with this
It turned out that Dr. Veatch said that
this distorts the carefully allocated system that we have under UNOS,
and my reaction is the quicker we blow it up the better we are going to
be. There is nothing carefully wrought out about the UNOS situation.
What they quickly discovered is taking into account subjective elements
that mattered to everybody led to such a hopeless degree of
disagreement amongst the various members of the committee that they
didn't want to talk about those things.
So what they do is they reduce themselves to a series of largely
useless formal criteria which would allow them to avoid the moral
ambiguity of collective choice.
The great advantage that you get from
directed donations is you don't have choices made by committees
that are paralyzed by their fundamental moral disagreements. Every
individual can look at every piece of subjective information they want
and if it's their kidney, they can decide who gets it and why.
In fact, one of the odd things about this
entire discussion on morality is the very clear standard natural law
tradition on giving was a theory of imperfect obligation, which says
that people can — under a duty to give it's not enforced by law,
but they could pick whomever they want and for whatever reasons and
give them whatever they want. Nobody else could ask the kind of
question, and that's exactly what's going on with these
What's the result going to be? Well, it turns out it's
going to improve things in my mind fairly powerfully on the recipient's
side. One of the things that you get with these wretched UNOS criteria
is that you can't take the subjective stuff into account. You
wait until people are so long in the tooth and so injured that the
useful lives that you get when people get to the top of the queue
are much shorter than they would have been if you could have gotten
people in the middle.
When people are making individual
judgments with their own organ and they take this stuff seriously, what
you're going to do is substitute recipients which will have a
longer life and a more useful life for people who have managed to
endure to the top of the queue.
And if you then allow this thing to work,
it will shorten the queues so even those people who remain on it will
do somewhat better than before.
So it seems to me that what we really
ought to do under these circumstances is to engage in a systematic
effort to try and figure out how it is that we continue to use the
Internet and similar devices to engage in a way in which we continue to
expand the matching capability.
Or to put it in another way, what we have
done, in effect, through the Internet is to figure out how it is that
we reduce the cost of matching, which means, in effect, that we have a
greater probability that the altruists will find themselves and to work
in that direction.
And I'm going to be in favor of the
situation with respect to anonymous donations, which become less
anonymous when people got to know one another, and I think that perhaps
the single most appalling, mindless, senseless, gratuitously cruel
proposal that has been made is the one by Zink and her colleagues who
said, "Well, we've got to ban all of this stuff because we
want to force people back on the queue."
This poor woman does not know that
it's not going to be a one-to-one ratio. In fact, probably if you
knock out direct donations, 95 percent of the people will simply
disappear at a guess.
And so what you're saying is that somebody's aesthetic view
of a queue which has no particular moral validity, is so strong
that you're willing to risk .95 lives every time you chase a
So let me, in effect, say and end in the
following words. I think the organ debate has been utterly marred by a
series of false forms of intellectual sophistication, ethical niceties,
aesthetic reservations, moral intuitions. There are too many dead
people out there.
I'm not quite sure whether you can solve it, but here is the
last sort of example. I co-authored an article in which we were
talking about this, which was rejected by JAMA. There were two
referees' reports which showed the stupidity of that operation.
The first one says, you know, you start
putting in all of these cash incentives. They're not going to make
the slightest bit of difference. Elasticity turns out to be zero.
And the other referee's report said, God, if you put in these cash incentives,
everybody will jump to supply these all.
It's what happens in this world. The problem about ethicists is
either demand is perfectly elastic or perfectly inelastic. If you
just think of things going up on a an angle, you will be so much
more educated than beforehand, and the moment you do that, those
graphs make sense and the referee's reports basically are the
very strong recommendation for shutting down JAMA on all matters
of social policy.
DR. EPSTEIN: The level of ignorance that
is encapsulated in that operation is a public scandal, and frankly, my
dear, I don't care.
Who wants to repeat this? It is a public
disgrace that a journal of that eminence should be able to operate in
that particular way.
CHAIRMAN PELLEGRINO: Thank you very
much, Professor Epstein. Very much grateful to you for observing the
time limit as well as your provocative remarks.
Next we will hear from Dr. Delmonico. He
is a Professor of Surgery at Harvard and someone who has to walk the
walk and talk the talk every day, and we'll, therefore, hear from
the bedside or I guess I would say the operating room bedside.
DR. DELMONICO: Thank you, sir.
I think whatever slides that we're
going to have, I think we'll have to just abandon all of that so
that I can respond to what we've heard here this morning, and
I'll be pleased to have those comments withheld until we're all
I'm here to represent not just
myself, but a number of organizations.
Can you hear that all right?
And those organizations would take
umbrage and concern about what Mr. Epstein has just said. I'm the
president of the United Network for Organ Sharing, and over the course
of the last 20 years thousands and thousands of hours of volunteer
effort by professional colleagues that Mr. Epstein associates with
today and who are, in fact, leaders within that organization have given
their time to make what can be an imperfect, but the best of what can
be done at the moment in terms of organ distribution and allocation and
That public policy is not ignorant, and just because his paper
from JAMA was rejected doesn't make all of that work in disrepute.
Mr. Epstein wants to serve those who could have a longer and more
useful life. That's, in fact, what his comment was just now.
I would suggest that he analyze the list.
The list is growing by an overage population that have been inadequately
served by preventive medical care, and it is not a matter of limitless
organs, but it is a matter of what might have been care as it pertains
to obesity and hypertension and atherosclerotic disease and Type
II diabetes. It has not been administered, that is, fueling this
The question about what is the average age of the person dying
on the list is apt because it's not the young person dying on
the list. We're talking about, as he put the main issue here,
about kidneys. More than half of the list now is the older age
population, and the sector of that list that is less than 50 years
of age is, in fact, stable and could be resolved by the unprecedented
increases of organ donors that we've had in the country since
That list is growing because of
inadequate medical care, and it's not just solvable by buying
organs, and the organizations that we're here today to represent,
and I'm going to read their statements as we get to that, we'll
make that amply clear.
And Mr. Epstein is going to have a big
obligation. He's going to have to overturn the National Organ
Transplant Act, and why I'm here as well is to say I wish him best
wishes to do all of that, but we have an expectation and we'll have
a fight. We'll have a fight at Congress that has already been
visited to say that that won't occur.
We're also here to ask of this august
group not to overturn the NOTA, not to bring a regulated market of
organ sales to this country and do so on behalf of international
organizations and their testimony is before you this morning.
Now, we'll return to the regulated
market in just a moment. I do wish to address some of the comments
that Bob Veatch made. He would have us reconsider the definition of
death. That is particularly disturbing to me as a transplant surgeon
of 35 years, and mentioned that the current definition of brain death
is incoherent and that a large group rejects the whole brain death
I'm concerned about the
representation of a large group because I know of no such large group,
and I don't find the definition incoherent in this whole brain
Whole brain means, for everyone in this
room, not only the cerebrum, but the brain stem, and the brain stem
controls our spontaneous respiration. What Professor Veatch was
suggesting is that somebody could be dead and breathing spontaneously.
I don't think our society is going to
accept that. They just plainly won't. Whether he's got maybe
1,000 individuals to speculate about this in Ohio or not, up to now the
legal definition is such that if you're breathing spontaneously,
you're still alive. There's something about breathing that is
sort of indicative of life.
Now, let's just take that scenario of extending the whole
brain death definition or making exceptions about that and then
paying for organs. I would ask this Council to think about that
scenario so that there's a 23 year old minority individual in
the intensive care unit, and now the intensive care physician comes
to the family and says there is an irreversible brain injury, but
your family member, this 23 year old, is not brain dead. Any further
treatment will be futile.
The current situation is that care can be
withdrawn and it does occur, but think of where Professor Veatch was
taking us. We're going to make an exception in this case.
We're going to consider this an extended kind of death even though
your family member is still breathing, and by the way we'll be
pleased to pay you for this individual's organs.
Think of the skepticism of our society
about the care of the individual to begin with. Now, just think about
I don't see that coming about as
standard medical practice. I just don't, and I would hope that you
would reject it.
Professor Veatch suggested theallocation problem is solved. It
isn't, and what is the dilemma? The dilemma is the list that
I talked to you about earlier and the expansion of that list from
the older age population.
Now, the government is telling us, that
is, the Division of Transplantation has brought before UNOS a
prescription that we have to be contending with the net benefit of life
achieved by a transplant. This utility factor now is very central in
what our considerations are all about, and the life span of a kidney
may far exceed what the life span of the individual that gets a kidney
at 65 or 68 or 75 years of age.
So the allocation of kidneys now has to
consider what net lifetime survival benefit might be realized by any
The question that was raised about a
young live person giving to an older age person is also apt because
these ethical considerations when you're having donor and
recipients before you are very much on one's mind as to what might
be realized. How long will this older age individual live and what
risk are we placing the younger person in giving such a kidney or part
of their liver or a lobe of their lung?
So I would say to you that allocation isn't solved; that the
net lifetime survival benefit is a priority before us; and we will
have to consider that as we reckon with this expanding list of older
I want to make a comment about a
solicitation. Professor Veatch said, well, this is a distortion of the
allocation system. I don't think there was clear thinking there.
Solicitation for deceased donors,
solicitation for deceased donors is fundamentally different than a
solicitation that happens with matchingdonors.com for live donors. For
deceased donors we, indeed, have an allocation system, and so if
someone puts up a billboard in Texas as they did and overcomes what
might be the most next medically urgent patient, that is a problem that
I have with solicitation as from the UNOS system of allocation. And we
can't allow that to occur.
And so last summer there were flyers, for
example, in the New England area, New York area, from individuals
soliciting for livers, and the conundrum we had was that this
individual might be receiving a liver ahead of other individuals in the
same intensive care unit who were of different gender, different
ethnicity, and were ahead on the list. We had to sustain the list of
allocation and not overcome that.
Solicitation for live donors is a
different matter because it does not involve allocation. It becomes a
directed donation, and there I can't regulate how relationships are
formed. So the UNOS position on matchingdonors.com is a concern
because of the finances that are entailed with it, but it is not
something that UNOS is prepared to prohibit because I can't tell
people how they may come to know of possibilities of live donors and
regulate how they develop relationships.
The transplant centers bear an additional
burden, however, of these donor recipient pairs that come along because
they have to assess the motivation of the individual and the
expectation of what will be derived as a result of their donation and
what imposition that might be on the individual, the recipient's
And I hope soon to have a conference on
this very topic to address those issues because there's an added
burden of responsibility that comes along when these donor-recipient
pairs come forward to a transplant center.
On the solicitation piece, however, the
UNOS position is that we can be of help. We will not object or
prohibit a solicitation, but at the same time, it isn't for UNOS or
the government to say, "Uncle Sam wants you." This is,
indeed, to be the vehicle of the solicitation because there are risks,
and those risks have to be accepted in an altruistic way.
The risks of live donation for kidney
are, yes, unusual, perhaps less than three percent of some kind of
complication occurring, but as it pertains to other organs, the liver
and the lung and now there are live donor pancreas and intestinal
transplants. They carry a higher complication rate. The liver
transplants, the death is one in 300. The complication rate is
anywhere from 35 to 60 percent.
If you're going to pay for one organ,
why is it that you wouldn't be paying for another?
Now, on a pair donation where Mr. Epstein
feels that it is, indeed, valuable consideration, there are other
attorneys in the country who don't think so. So it becomes a legal
dispute, and the basis of that is to say that a paired donation remains
And it is a gift if it's done
altruistically and simultaneously.
The valuable consideration clause was put in the 1984 National
Organ Transplant Act principally to prohibit the sale of organs,
and that is what has been sustained. Pair donations that are done
with the acceptance of transplant centers, now many, New England
and a variety of places, Baltimore, et cetera, they're done
in the context that this is not a violation of the National Organ
Transplant Act. No one has some notion that that's what is
And the concept about valuable
consideration is not taken that this kidney is anything else but a
gift. I have some trouble with the way that Professor Veatch presented
his proposal about voluntary paired donation because I think it's
flawed by the premises of suggesting that one could have the better HLA
match as an incentive to enter into the system that he proposes.
If you don't have an HLA identical
match, any other HLA match today is not consequential to successful
outcome, and so that, in fact, is what has propelled living unrelated
donation in this country, about 30 percent of them. About 30 percent
of them are, indeed unrelated genetically, that is, they're either
spouses or friends or anonymous.
I personally am very supportive of the
paired donation system. I hope that UNOS will develop such a system,
and there are these existing already as I mentioned in certain
locations of the country. But I don't anticipate that the strategy
that Professor Veatch proposed to you where an O donor having the
knowledge of a recipient before them would enter into a system in which
there is a lack of awareness about how the transplants would be
occurring, et cetera, and that they would go into that system.
Just from a transplant surgeon
perspective, the logistics of these paired donations are complicated.
They're like a space shot, and when they're done, we even have
to call the corresponding hospitals to know that the anesthesia is
being administered simultaneously.
And the work-up, well, all right. Thank
you, Mr. Epstein. I was very reserved in holding any remarks. So if
you would be kind enough to do the same, sir.
It is, indeed, altruistic because
they're giving simultaneously, but what I'm suggesting to you
is it's complex, and it is not something to be taken, well, with an
expectation that an O donor knowing the recipient will be readily
available to come into such a system and have the expectation that
they'll be happy to do so, I would suggest to you not.
Now, in my remaining time I wish to deal
with what Mr. Epstein said: let's not have any illusion that
economics don't apply to body parts. Well, he's just flat
wrong. I don't think it's an illusion, and I'm going to
suggest to him by the statements of the following organizations that
he'll have to contend with as Congress takes up this matter and as
you do as well.
The United Network for Organ Sharing is opposed to a regulated
market for organ sales, and the first, if I may bring to your attention
of statements that is before you is from UNOS, and there is a series
of them now before you as well.
And so that it is not Francis Delmonico
per se who is before you, but all of these organizations knew of this
presentation before this Commission and wanted to officially register
its concern about any concept of a regulated market in this country and
the impact that that would have on this country and transplantation
practice and the practice of transplantation around the world.
So I would ask that you take these
statements with some consequence because they've been derived for
bringing to your attention the profound opposition of these
organizations to a regulated market of organ sales.
So UNOS rejects it as a means of
increasing the supply for organs for transplantation as not being
ethically justifiable. It would diminish the respect of persons
resulting from making body parts a commodity. That's no illusion.
And the concern is captured in the
ethical principle of respect for persons. There would be a diminished
voluntariness of consent. This concern is expressed by the principle
of autonomy. There would be a diminished emotional support for
families. This concern is expressed by the principle of visits
Now, I want you to also know that
we're not opposed for removing financial disincentives from an
individual to be an organ donor. So to the extent of a reimbursement
of expenses, I don't see that as a problem, and I think it is
something that could be certainly considered as proper, and so it says
The American Society of Transplant
Surgeons is opposed to a regulated market of organ sales. That's
not an illusion. That's a reality that Congress and I would hope
that this Commission would contend with. The surgeons are opposed to a
regulated market of organ sales.
And Dr. Cosimi wrote to me to bring to
your attention this opposition, and it was restated recently.
"The ASTS believes that living and deceased organ donation
represent altruistic acts. The ASTS has consistently been strongly
opposed to the buying, selling, and brokering of organs for
transplantation in agreement with the NOTA, which makes it illegal to
exchange organs for valuable consideration. The ASTS reaffirms that
The next is a statement from the National Catholic Bioethics Center
and Jon Haas. "Pope John Paul has stated acts of selfless
love are most solemn celebrations of the gospel of life and a particularly
praiseworthy example of such love is the donation of organs performed
in an ethically acceptable manner with a view to offering a chance
of health and even life itself to the sick who sometimes have no
"The National Catholic Bioethics
Center strongly opposes any regulated market of organ sales. Such a
scheme would harm the charitable nature of organ donation and
substitute in its place a market for buying and selling of human body
parts. It is not a matter of just economics. We can't equate
widgets with organs just from an economic perspective.
"The human body is not a commodity,
but a gift which God has given us limited stewardship." Now,
I'm quoting this. "Furthermore, to turn the body and its
organs into commodities places at great risk those who are poor and
vulnerable by making them susceptible to the allure of monetary gain
from a surgical procedure which in no way benefits them
If we had a regulated market in this
country, what would be to stop immigrants from wanting to come to this
country to sell their organs? How would that be justified?
And what impact would that have on the
rest of the world in which illegal black market practices are
occurring? The World Health Organization is very concerned about that,
and they have a statement as well here. I've been with them in
Manila and Karachi and South Africa. One of the slides that I would
have put up, but I can show you if you would just refer to page 1, it
talks about kidney trafficking.
A woman in Brooklyn who goes to South
Africa and the vendor comes from Brazil and it is brokered by an
individual from the Middle East.
A regulated market in this country would
set that kind of practice into acceptability.
The National Kidney Foundation opposes a regulated market for organ
sales, and the statement is there before you. Congress has appropriately
refused to revise, nor to initiate demonstration projects for payment
of organs. Many Americans are not inclined to be organ donors because
of their distrust of health care system, including the concern that
the care of a potential donor might be compromised if their donor
status were know. Financial incentives would intensify this mistrust.
Think about altering the definition of
death and saying, "Well, no, we'll pay you for some
organs." What of that mistrust of the medical system? And the
National Kidney Foundation calls attention to that.
My good friend Dan Brock at the Harvard
Medical School, Department of Ethics, there's a statement there
before you as well, and he concludes by saying that if a system would
unavoidably lead to a serious exploitation of such donors either here
or abroad, that would be a strong reason against implementing a
The Transplantation Society
internationally is opposed to a regulated market of organ sales. An
endorsement — now, I'm reading verbatim, and the statement is
there before you sent by Katherine Wood to me just a few weeks ago,
again, in preparation for this presentation, to bring all of these
testimonies to this Commission's attention about its opposition to
such a regulated market.
"An endorsement of such a plan by the President's Council
on Bioethics would send a profound and troubling message to the
United States Congress and the transplant community worldwide.
As you are aware, the transplant community is now confronted by
transplantation tourism that has an international dimension. The
transplant tourist often obtains a kidney in countries in which
poor individuals are exploited for their body parts."
And parenthetically, there is a picture
very well depicting what this is all about. If you go to the second
slide set, you'll see a picture of vendors in Karachi and the other
one, that from the Philippines.
"It is the exploitation of the poor
that makes the practice unethical. Regulating the practice by a
government program does not make the practice ethical. If the United
States were to adopt a regulated market by the United States
government, many challenging issues would emerge. Could the U.S.
government justify limiting the sale of such kidneys by its citizenry?
Would not such a regulated market for the sale of organs drive
individuals from other countries to come to the United States to sell
his or her kidney?
"The Transplantation Society urges the President's Council
on Bioethics to affirm an unequivocal opposition of transplant tourism
and a regulated market of organ sales."
With that I'll conclude, and I thank
you for your attention and that I might be here. Thank you very much.
CHAIRMAN PELLEGRINO: Thank you very
much, Dr. Delmonico, and thank both of the speakers for being very
respectful of the time of the council.
You have now an opportunity to ask
questions of either of the speakers, and I might ask that you direct
your questions to a specific speaker if possible.
Dr. Foster, I have you first on the list.
DR. FOSTER: Thank you.
Dr. Delmonico, it seems to me that
it's a curious thing from you and all of the societies that you
just quoted, that you simply want to stay in the status quo. That is
to say, why is there no concern for the fact that the poor cannot get
There are other things I don't even
want to talk about. In Dallas, let's say with a kidney it takes
five years, and you go 20 miles across the way to Fort Worth. The UNOS
system gives you a kidney. You can get a kidney, you know, in two
years, or you can go to Jacksonville, Florida, and you can do things.
But I'm very concerned about your
unconcern for the poor, that they cannot get transplantation done. Why
I mean I've got people dying right
now in Parkland Hospital that nobody will transplant because they
don't have any insurance or money. Why? Why do you want to keep a
system intact that doesn't work?
I mean, it works for the people who have
money or have insurance, but it doesn't work, and it seems to me
all I heard you say is that this is a good and wonderful system that we
should not in any way change.
DR. DELMONICO: Dr. Foster, may I respond
DR. FOSTER: Sure. That's really
what I want. What I want to know is why today in the United States —
at least I don't know how it is in Boston, and so forth — but
certainly in Dallas —
DR. DELMONICO: I'm very familiar
with what's happening in Dallas, Dr. Foster.
DR. FOSTER: Well, please. I mean,
I'd just like to hear why we want to stay with a system, and my
transplant surgeons don't feel like you have cited. I don't
DR. DELMONICO: I know them very well. I know
(Dr. Goran B. G.) Klintmalml at Baylor very well. I haven't
suggested that all of these organizations are opposed to regulated
market, that that justifies the system as it currently exists.
There are disparities about access to the list that are unequivocally
there, and I don't accept that at all.
So I don't want you to make a
conclusion, Dr. Foster, that opposition to regulated market is to say
that the system as it currently exists as to the disparities in getting
on the list or the disparities once on the list about transplant is to
be solved by a regulated market or that the regulated market is then a
conclusion that an opposition to that is a sanction of the current
It isn't. So I'm concerned just
as you are about the poor that might be in any location of this country
and their insurance issues that don't get them to the list or that
they're identified as having renal failure, don't get them
through the system that enables them to have the proper medical care
that someone else might have.
Those inequities do exist. The
opposition that you just heard from all these organizations is not
about that at all, and UNOS is very much concerned about these
disparities. That's why the meld system was introduced.
That's why the changes in lung allocation were introduced.
That's why we are trying to change the allocation system of kidneys
in this country.
So please, if I can say to you, the
opposition about a regulated market is not justifying or saying that
the current system is perfect or that what we want to stay with.
DR. EPSTEIN: Can I answer?
DR. FOSTER: Well, let me just say one.
I would presume as a transplant surgeon that you would like to have
enough organs, whether it's young or old or poor or so, that there
would be an opportunity for this treatment which has been wonderful to
be available, but you still haven't answered the question to me,
how you want to solve that.
You say, well, we're concerned about
that. Where does this concern go? I mean it doesn't help me for
you to say that you're concerned about it. What I want to know is
what are we going to do about it. Are we going to — I mean,
what's your answer to this?
DR. DELMONICO: My answer is that it
doesn't resolve by a regulated market, number one.
Number two, okay, so what positively? We
can increase deceased donation as we're doing. We can increase
live donation as has occurred. We can do the types of paired
donations, et cetera, but I think what you're as well going to have
to wrestle with is that the reason why the list is expanding as it is
is because of poor preventive medical care, and it, in fact, is the
case, and it's the poor person that doesn't get that care that
is becoming a major aspect of that list.
So I would ask you, sir, what are you
going to do about heading it off at the pass, as it were, instead of
just coming down to the very end of it and say, "Well, un-huh, now
we need organs."
Why is it that you wouldn't be
considering better preventive medical care as a component of obviating
the need for the organ to begin with?
CHAIRMAN PELLEGRINO: I want to point out
I have —
DR. FOSTER: I can answer that, and I
spent my life as a diabetologist, and if you want to read some of the
stuff, you know, that's know. I mean, New York City, somebody
facetiously said that uncontrolled diabetes is causing more deaths than
9/11 or anything else. So I mean, I don't want to get into that.
But if we've got a curable form of
diabetes right now, but obesity is not curable, I mean, practically.
It sounds like we're getting in an
argument. I don't want to do that, but I also don't want to
give the answer that we can do better preventive medicine is the
problem. I mean, that's not going to get more organs to transplant
if we live longer and solve those problems.
DR. EPSTEIN: We have spent how much on
Medicare and Medicaid? Most of what we do by way of incremental
expenditure is badly managed. More money in that direction may have
some good, but that doesn't mean that you don't move on every
And Dr. Delmonico's proposal is to
the extent that he maintains the ban on regulated markets a proposal to
rearrange deck chairs on the Titanic. The shortage is ignored,
and the only viable method to stop it is shut off.
The arguments from black markets and
overseas prove exactly what one says with every other commodity. You
make something into a black market commodity, and you get shady
operators and corrupt transactions. You bring it above board and much
of that coercion and intrigue disappears.
So what you're seeing is an artifact of restrictions. It's
just why the slum lords of New York are miserable and skuzzy, because
of rent control, and in Chicago it's just not an issue because
you've got the market clearing prices.
Nobody says a widget is the same as an
organ. What you're saying is the same forces of supply and demand
work, but the individual transactions in market will obviously take
place in different ways, just the way all other commodities are sold in
You don't sell jewelry in the same
fashion that you sell pears, even though both of them are widgets. So
it's just a complete misconception.
And the other point is all of the
recitations, I have never read a more pathetic document than what Mr.
Graham submitted to you as justifications for endless numbers of
lives. I urge everybody to read it and ask whether or not they could
think of 1,000 counter-examples.
If this is the best you can do, it's
politics and muscle. It is ethically barren.
CHAIRMAN PELLEGRINO: Dr. Delmonico, a brief
reply because we have seven members of the Council who wish to comment.
DR. DELMONICO: Well, I'll only say
this. It isn't me speaking here. It's all of these
organizations, and you'll have to reckon with it.
DR. EPSTEIN: Well, no. If you want to
play tough guy, you're winning.
CHAIRMAN PELLEGRINO: I would ask that each person
ask a question and you will have the opportunity to respond, and
then we'll try to keep the debate down for the moment. I want
to get the Council members in. The meeting is for their information
The next question I have is from Dr.
DR. MEILAENDER: Professor Epstein, I
would like to think about ethics a little bit with you if we could.
You said a couple of things right at the very start of your
presentation. You said there's only one fact, sort of the chronic
and irreducible shortage of organs, and you said, and then it has been
sort of involved in the ongoing conversation — I don't have the
exact quote — but something like there's nothing so unusual about
organs that the laws of economics don't apply.
And I am so benighted as to doubt that in
a way and would just like to think about it a little bit with you, and
one way of thinking about the world is that — and I mean, I think
there was a time when lots of people thought this way — is that there
are human beings and there are resources, and you have to think about
how to distribute resources to human beings. And we can get into
ethical arguments about what the best way to do that is.
Another way is to think about human
beings or at least parts of human beings as themselves resources to be
distributed, but that's a fundamental shift. That's a
different way of thinking about the world, and it raises all sorts of
troubling questions about where exactly we locate the person whose body
is a resource now to be distributed.
And if we're going to make that shift
and think about the person as a collection of resources that are
commodities to be distributed, we might want to worry about those
So what it seems to me we need, I mean,
there is a starting point presupposed in what you said, and the
starting point is that it's better to think about the world in such
a way that human beings or at least the parts of them become resources
that some other human being kind of floating around above the body
distributes. And I don't find that a terribly persuasive way
myself to think about human beings, but I'd just like to hear what
you would say about that.
And I'd just like to see if you think
more my way, then you'd never say that the only fact is that
there's a chronic and irreducible shortage. That might be one
fact, but there would be some other facts about how to think about
human beings that would be important.
How would you take that up?
DR. EPSTEIN: Look. I mean, there is a
very long tradition which starts to argue that the life of a human
being shall not be treated as a commodity. My favorite example of that
is Section 6 of the Clayton Act in which they announced that provision,
and the net effect of that was to organize labor cartels and
That is, lots of times when people start using the theories that
commodification is terrible, they don't mean that they can't
sell it. It means that they can monopolize it.
And so you have to be aware of the fact
that there's a lot of abuse that is associated with that section,
and then even in its proper sense, virtually every serious economist
when they talk about resources divides them into two halves, human, on
the one hand, and natural, on the other. And —
DR. MEILAENDER: But you wanted to talk
DR. EPSTEIN: I am talking — yeah,
I'll talk ethics.
DR. MEILAENDER: For the moment I
don't care what every serious economist says.
DR. EPSTEIN: Because I mean what happens
is these are resources, the human beings, and in fact, an ethicist is
committed to treating them as resources when they're willing to
allow a donation to take place. That is a transfer of resources from
It may well be something which is done
without consideration in the technical sense of the word, but it is
certainly a transfer, and the justification for it is that the gain to
the recipient translates into overall social welfare.
The problem about ethics is it is basically an empty set unless
it can transform itself into some kind of a social welfare function.
To give you an illustration, the Kantian proposition that every
individual shall always be treated as an end and never be treated
as a means, right? If you take it —
DR. MEILAENDER: That's not the
DR. EPSTEIN: Well, that's —
DR. MEILAENDER: It's that every
individual shall be treated not as a means only
DR. EPSTEIN: Not as a means only. Okay,
but I mean, if they're not, then if they can be treated as a means
partially, it has got to be in the service of some end. And what the
purpose of ethics is to figure out how you allocate these resources in
which to get the greatest maximum of good for all people inside the
Given scarcity, that translates back into
an economic problem, and if you start looking at the Kantian
propositions, it begins the prohibition against exchange because of the
fear of exploitation, and that becomes so utterly restrictive because
you can't have labor contracts at that point for so-called ethical
Well, once you allow voluntary exchange
of labor, then you are always worried about the specter of whether
it's slavery, and you're going to ban those.
I mean, one of the things that was wrong
with Dr. Veatch's presentation is he somehow assumed that the organ
problem was worse because we don't have a strong minimum wage law.
But I can't think of a single ethical argument in favor of a
minimum wage law, and I wonder what would it be.
CHAIRMAN PELLEGRINO: May I intervene for
a moment? We do have a limited time, and I realize the problems
between you are difficult to resolve in a brief time, and I understand
you. We have a question of civility and courtesy for the rest of the
members of the Council.
This is no reflection on anybody's
involvement in the discussion. I understand that, but I would like to
call on Peter Lawler and we might come back if there's time to pick
up your discussion.
DR. LAWLER: I first want to congratulate
both presenters for very effective and illuminating presentations.
I'm against the trafficking in live organs and even somewhat
creeped out, as I said before, by the donation of live vital organs,
and so I guess I generally agree with Dr. Delmonico, but I also
as usual am very moved by Dr. Foster.
And so let me give you the two hardest
questions I would have. Number one, given that there should be no
market in live organs, what do you think about the market he suggested
in dead organs or some payment for dead organs?
And number two, this transplant tourism
thing from the point of view of justice. Now, let's say the U.N.
can't stop it, which is likely since they can't stop anything.
DR. LAWLER: Then prosperous Americans
will avail themselves with increasing frequency with transplant
tourism. It will be shady, but not that shady, and they'll
generally get good results, and so the only people who don't have
access to live organs unjustly procured will be people who can't
afford to engage in transplant tourism.
And I don't think we'll ever be
tough enough to say to the transplant tourist, "If you come back
here we're not giving you any medical treatment because your kidney
was unjustly acquired."
So from the Rawlsian, left wing justice
point of view, aren't we entering into a very unjust phase insofar
as kidneys will be available to everyone except people who can't
afford to engage in transplant tourism?
CHAIRMAN PELLEGRINO: Dr. Delmonico, Dr. Epstein.
DR. DELMONICO: Transplant tourism, the
WHO is going to do something about it. The South African situation was
shut down, and the physicians there were arrested. I think that's
the fact. Whether you agree with it or not, the premise was that the
U.N. can't stop it, sir.
Americans are going to China currently
and buying organs from executed prisoners. Six thousand or so organs
last year were derived from executed prisoners in China. The President
of China is in town here today. The Vice Minister of China within the
last ten days said that they will have a legal ban on transplant
The WHO plans to go to the variety of
markets that exist, black market that exists, and try at least within
the legal framework to exercise what is the illegality and make that
practice stop. I have no illusions about that. However, the fact that
the poor might not be able to avail themselves of transplant tourism in
my view is not a reason to sustain transplant tourism. The fundamental
problem is the transplant tourist situation, and that's what we
have to address to try and prohibit.
No marketing for dead organs. If you
finance marketing for dead organs, how can you then justifiably say we
won't finance marketing for live organs? I don't know how to
Where there is no risk and you finance marketing for dead organs,
why wouldn't we then want to finance marketing for live organs?
And the problem is we don't wish to commodify life organs
just as another economic tool. That's the fundamental difference.
You either accept that or you don't,
and once you say then that you're going to provide that kind of a
market, why would we stop at a kidney? Why can't we sell a lobe of
the lung? Why can't we sell a part of the liver? And why is it
then that the same justifications that are applied apply to other kinds
of social behaviors that are not accepted, for example, prostitution?
CHAIRMAN PELLEGRINO: Professor Epstein.
DR. EPSTEIN: Globalization is an effort
at circumvention. World trade is, in general, a good thing. The
problem with the circumvention in these cases is that if you're
starting to take organs off of dead people, these are not voluntary
markets when they're sold by the Chinese government.
And what one wants to do is to open up
legitimate sources of supply so that these perversions don't take
place, and let me be very clear. I did not agree with Dr. Veatch when
he wants to kill people off prematurely in order to increase the supply
of organs. I think it's a market of desperation and sadness that
people actually think you're going to have to sell diseased organs
under these circumstances or give them away.
I would rather sell a healthy organ than
give away a terrible organ. So I think what you're doing is
you're looking at the cure and treating it as part of the disease,
which only in the organ transplant community is compensation coercion.
And if you keep with that equivalence you
will basically think that coercion has to be avoided, and it's
worth paying the price of 20 deaths a day to avoid it.
I think it's crazy. I mean, to somebody who is in the outside
looking at this community I can't even understand it, and just
to go back to the ethical point, I do not know of a coherent nonconsequentialist
ethics in a identical form. This is the answer to the earlier question,
which essentially is sustainable, and that's why in the end
you can't do ethics unless you know some economics.
DR. DELMONICO: Dr. Foster, I just want
to say this. I have the same sense of the problem of the death on the
list. Trust me. I can only want to assure you in a personal way that
I do. I'm just unable to solve it by regulated market. I
can't go there.
CHAIRMAN PELLEGRINO: Professor
DR. EBERSTADT: I have two questions for
you, Dr. Delmonico, and one question for you, Professor Epstein.
DR. EPSTEIN: I'll wait my turn.
DR. EBERSTADT: Okay. Dr. Delmonico,
you've associated yourself with the ASTS statement here. The first
one says that payments would exploit the most vulnerable members of our
Well, I note the phraseology "most
vulnerable" is an ordinal rather than a cardinal ranking of
people. There would presumably be a most vulnerable member of the
Forbes 400 list. Is there any level of general affluence and education
at which the concerns about the most vulnerable member of society would
abate or reduce?
Secondly, the statement here talks about
arbitrarily assigning a market value to body parts. With enough
technological innovation, I can imagine, and already science fiction
writes have imagined, the notion of manufactured body parts and body
What if, obviously a hypothetical,
science fiction-like future world; what if Microsoft were able to
manufacture body parts and the richest man in the world, Bill Gates,
were to sell them? Would the reservations about the sales of
human-like bioparts still obtain that you mention here?
Professor Epstein, you've made the
economic argument about the benefits of a national market for exchange
of organs. Would you extend that argument to an international sale,
international commerce in body parts?
DR. DELMONICO: In the regulated market
in Iran, it's the poor person that sells himself, and when Bob said
that, well, they've cleared out the list, we have no idea about the
list. I actually know the data, the prevalence about renal failure in
Iran, we never know who might have gotten to the list.
The vulnerable is that it's the poor
person. It's the expectation that it will be the poor person that
wants to sell the kidney and/or other organs because of their need to
do so to generate those funds.
I don't have an expectation that it
will be other than a poor person because that's what the experience
has been internationally.
The arbitrary market piece, when the
Pennsylvania folks had the $300, you know, that they were going to
assign for funeral expenses, et cetera, you could imagine that every
state might take up such legislation. The problem of all of that was,
and we wrestled with this in the American Society of Transplant
Surgeons. What money would you assign in Pennsylvania or in Texas?
Once you start seeing that we're
going to provide some funding for this, where is it that you declare
Uncle Joe in Texas is worth 5,000, but you may not be able to get that
And by every state it becomes somewhat
arbitrary as to what those monies might be. Within those legislatures,
I don't believe that we would be able to make a consistent
determination of that monetary amount, and it becomes arbitrarily
applied. What is the value of Uncle Joe in Texas for his liver, and
does that differ because Uncle Joe is 65 or 25?
That's, in fact, what goes on in
these market situations. There's a difference in gender and in
ethnicity and by age as to what the market brings for those organs.
DR. EPSTEIN: As well there should be. I
find it remarkable. The problem of valuation and multiple prices exist
in any market which is regulated. If you want to find out how to do
it, you just simply remove all of the state mandates for stipulated
sums, and you will get an equilibrium because you'll eliminate the
So what you're talking about is the
value problem that comes under regulation, not the value problem that
comes under markets. The question is how do you determine values in
markets. Remember what Hobbes says. It's the appetite of the
contracting parties that do it. There is not a single commodity or
non-commodity that works in any difference.
Even in such delicate barter relationship
as marriage, it is ultimately subjective and joint, and all we can do
is observe the manifestations of consent and infer from that mutual
And what we can also observe is when
there is no compensation possible, we will get chronic shortages, and
all of the talk and all of the "trust me's" in the world
will not change that simple brute fact.
CHAIRMAN PELLEGRINO: Dr. Kass.
DR. KASS: I have two questions, one to
lean on each of you from the side of the other having listened to the
Professor Epstein starts preoccupied with
the fact that people are dying because of shortages, and that's the
only fact that is relevant at least for this argument to start with.
But Dr. Delmonico in the written paper
and also here is concerned about the deformations of medical practice
if the vendor relation enters, referring to just a sentence or two in
the article, repeatedly speaking about the indignity of the
commodification or trading of body parts, quite apart from the question
of the coercion of the poor, which is a separate matter.
And he raises the question of whether or
not this push for an ever more expensive and ever more morally
challenging technical solution isn't in a way the wrong system
error, that there's another system error having to do with
prevention of the disease.
I want to know from Professor Epstein
whether any of these concerns matter and, in particular, the question
of whether or not there really is something different about the human
body and its parts such that there really is a loss when you begin to
trade it around, and that's made even worse when you begin to trade
it around for money.
On the other side, to Dr. Delmonico,
Professor Epstein's one brute fact that he harps on at least in our
present situation, and Dr. Foster has underlined it, demands some kind
of response. Let's say for the sake of the argument that all of
these little partial solutions of Robert Veatch amount to nothing and
don't give us the additional organs that you need.
Are you in a way prepared to say for the
time being those concerns for the change in medical practice, those
concerns for human dignity and its violation are sufficient so that
I'm willing to say as a transplant surgeon it's a sad necessity
in the situation. These people are going to die.
Let's assume that he's right,
that the only way really to produce the kind of equilibrium of supply
and demand is through markets, and that we face that fact. Are we then
prepared to say that's just tough?
DR. EPSTEIN: Well, I'll answer my
question first. I always think dignitary stuff is nice, but it's
the kind of thing which you could handle in 1,000 subsidiary ways after
you open up the set of markets.
You know, you watch funeral homes,
right? They're markets. They manage to work for exchange, and yet
it's strange. In a funeral parlor nobody treats the dead body as
though it's a piece of meat to be thrown down by a hook,right?
Because it turns out the conditions and the demands and the empathetic
situations of the suppliers and the buyers in these markets require a
different kind of delicacy and tact.
My own view is that if you allowed this
thing to come up, the way you will handle the dignity thing is by the
development of customs and trade and exchange and cooperation and by a
selection of people who will be part of that particular community who
have the greatest level of empathy.
So I think all sorts of forms of
selection in there will do it, but to say that the diminished respect
for organs resulting from making body parts a commodity, if that is a
cost, and I don't think it is particular, it's trivial compared
to the value of a life.
What would you monetize it at, $1,000 and
a life at six million? I mean, maybe you're right that there's
something there, but it's a cost, and it's certainly not a cost
that gets near enough to amount to the prohibition.
You yourself said, and I think it's right, if you really thought
this (made the poor more vulnerable), put a minimum taxable figure
of $5,000 or $50,000 in income before you can sell.
My view about that is I would rather not
see the restriction in there because now you're telling the poor
there are fewer opportunities than anybody else, abut I'd certainly
rather have that than the total thing.
I mean, make it very clear. On a day-to-day basis, anything that
loosens this up I will accept, including all of these so-called
altruistic bartered exchange that are done simultaneously because,
of course, there are sales, on the one hand, between parties, and
there are voluntary gifts within the family, and they're both.
CHAIRMAN PELLEGRINO: Dr. Kass?
DR. KASS: I will pose a question and let
him not answer.
CHAIRMAN PELLEGRINO: Okay.
DR. KASS: For all of us, what about the Will
Gaylin? It was Jonas actually who thought about it first. These
lives could be saved, but only really by perfusing corpses and letting
them be farms for these parts, by consent with payment, with or
Do we want to live in a society in which
that is the way in which these lives are saved or are those minuscule
considerations compared to these lives?
I think there's something in your
economistic account here that just is left out, that's missing,
that's of great importance.
CHAIRMAN PELLEGRINO: Dr. Delmonico.
DR. DELMONICO: Well, you go ahead.
DR. EPSTEIN: Oh, sure. I mean, Leon, the point
is you could always invent a case such that you would allow for
voluntary consent that nobody would want to do. The real question
is, all right, open up this possibility and see if it's a ghoulish
as you say. How many people take advantage of it?
And the answer is you won't find many
people taking advantage of it if you could find other forms of exchange
that have a higher level of tolerance both for themselves and for
There has got to be a selection effect
within markets. Just because you make exchanges legal doesn't mean
that anyone is going to want to do each and every one of them, and
there is a second social filter. The argument here about norms and
respect comes in in the way in which markets operate. They're very
heavily norm defined, and so forth, and I'm not being economistic
and saying that everybody has to be a brute rational choice guy.
I'm saying if you open up exchange,
all of these subjective and very important elements can be brought into
the occasion as they are right now in delicate human arrangements with
psychiatric care, with sexual dysfunction, with funeral arrangements.
They do not look to me in exactly the same way as you an A&P, and
so as long as we see that these voluntary differentiations take place,
I don't think the argument from dignity gets you within 1,000 miles
of a ban.
DR. DELMONICO: It's because I don't
run an A&P. It's because I don't want to place a monetary
value on life that we take this opposition, and it's not me.
It's all of these organizations that I just brought before you.
And that becomes really the profound difference.
Dr. Foster, I can't do it. I cannot
come to myself personally as a surgeon-physician, and I respect the
fact that you are as well and that you care about the patients as well,
and I do respect that.
But what I can't do, nor can these
organizations; I can't be a part of placing some payment, monetary
value on somebody's life to say that's what it's worth in
some economic terms, and it goes to the core of what this is all about,
and it's that difference that separates us.
CHAIRMAN PELLEGRINO: Do you want a
DR. FOSTER: I think that, yes,
you're answering Leon's question. You say, yes, it's sad
that all of these people have to die without organs, but the price is
too high. So your answer to him is yes, our societies believe that the
cost is too high and that the cost of their lives is not high enough to
DR. DELMONICO: Well, it's not a matter of
cost that it's too high because if we had an accurate source
of organs I'd be the first one on it around the clock to get
DR. EPSTEIN: Well, Dr. Delmonico, there's
a big difference between saying I can't do it and no one else
in the world can do it because I have these strong instincts. What
you're doing is you're coercing other people through these
organizations, and if the vote is 99 to one, then 99 surgeons don't
do it and the other guy does it. You have to explain not to your
aesthetic preference for staying out of the purchase market; you
have to explain why you're going to stop other people from doing
it. I have —
DR. DELMONICO: It's not me who's
stopping anything. It's —
DR. EPSTEIN: What do you mean it's
not you? You and your organizations are making transactions illegal
because you don't like them.
CHAIRMAN PELLEGRINO: Especially, DR. EPSTEIN, as a lawyer I'm sure you're familiar with the role of
CHAIRMAN PELLEGRINO: I must ask for a
little more restraint in the responses and a little more brevity. We
have five more members of the Council who wish to comment, and so
I'm going to take the Chairman's prerogative and extend the
time of discussion. I don't mean in any way to restrain
anyone's comment, but they can be made with more brevity and
perhaps more on the point.
Now I would like to call on Dr. George.
PROF. GEORGE: Thank you, Dr. Pellegrino.
I do have a question for both presenters,
but before asking that question, I'd like to ask Professor Epstein
just to clarify the sense in which he's using a particular term,
and it was the term "consequentialism" in response to
I certainly agree with you that someone
who wants to do ethics seriously, at least in quite a wide domain, has
to know some economics, and indeed, a good deal of economics.
And I also agree with you that someone
who believes that, as I do and you do, has got to reject a purely
deontological approach to ethics.
But then you said any coherent sensible
ethics will, therefore, have to be consequential. Now, maybe
there's a sense in which that's right, and if so, I want to
give you an opportunity to clarify the record on that.
When folks like Professor Meilaender and
Professor Gomez-Lobo and someone like me hears the term
"consequentialism," of course, we think of Elizabeth
Anscombe's definition of it when she introduced the term into
ethics, which essentially boils down to the view that in situations of
morally significant choice, one ought to choose that option which
promises overall and in the long run to conduce to the net best
proportion of benefit to harm, and there's your master principle of
Now, I think you can believe all of the
things that I said that I share with you in believing, rejecting a
purely deontological ethics thinking that economics is something we
really have to understand to do ethics right today, and across a wide
domain without embracing consequentialism in that sense. All you have
to believe is that consequences do matter.
But, of course, that's going to be
true for lots of people who reject consequentialism in the sense that
Anscombe meant the term in the sense that she rejected it in favor of
saying an Aristotelian approach that does take consequences seriously,
but doesn't embrace any such master principle of ethics that would
involve aggregating goods, commensurating them and making decisions in
the way that I described.
DR. EPSTEIN: And that's why the
economics is important. The Anscombe definition of consequential is —
talks about a family. It ignores the distributional and separation is
concerned. If you go back to the Pareto definitions or the
Calder-Hicks definitions, each of them in effect treat each
individual's occupying unique space and the utility function so
that the gains to one can simply not be taken into account, ignoring
the losses to another. There is either a question of explicit
compensation required or, in effect, a hypothetical compensation so
that this is not sort of an aggregate blob utilitarian thought, which
often I think leads to immense troubles, utility monsters and so forth.
For example, you get one person who says,
"I care so much. Trust me," that the harm to everybody else
doesn't matter because I have this over large psyche.
The distributional constraints in a
Pareto system, I think, answer the Anscombe situation, and every
Kantian proposition is consistent with a preference for Pareto over
PROF. GEORGE: Well, the point that I'm
pressing is that the options aren't the kind of utilitarianism you
describe and reject, on the one hand, or Kantianism, on the other
hand. But I wonder if the alternative that you've proposed is the
only possible alternative.
I mean, how would you view, for example,
a straightforward contemporary Aristotelianism?
DR. EPSTEIN: The same problem that you
always have with all of these things. There's too much
essentialism in it and ideas that there's sort of abstract
categories into which people fall from which they cannot go out, too
much of a fixed definition of what has to go in or not into the
individual subjective utility functions. I would leave that thing
completely unbounded. So I would not sort of limit it to certain
kinds of taste as opposed to other forms of taste though that you have.
But even if you want to stay within this
Aristotelian framework, the hard problem for political ethics is the
question of when we use state coercion to justify the limitation of
choice of other individuals, and the Aristotelian position has always
been very hard because it's essential to say that certain
transactions which have mutual gain for the parties can be trumped
because of some kind of philosophical objection.
I regard that class of cases as empty,
and since I do that is why the "trust me, I wouldn't do this
kind of surgery" is fine for Dr. Delmonico not to take those
patients, but it's not fine for him to tell Dr. Foster he can't
find another physician to do a paid transplant.
And the fundamental point is the
difference between coercion and voluntary participation, and the
Aristotelian theory is very weak on policing and working that
PROF. GEORGE: But you take that view,
obviously, based on a set of philosophical assumptions that you make
which themselves can't be justified in economic terms, for example.
DR. EPSTEIN: No, I don't think
that's right at all. What I do is I assume that each individual is
autonomous. I assume that they have well ordered preference functions
one way or another. I don't do it from economics. I get that
thing justified from knowing if they are bid or trying to —
PROF. GEORGE: Those are straightforwardly
DR. EPSTEIN: Well, and you try to learn
them by learning as much as you can about both the moral — not the
moral — the emotional and cognitive basis of human behavior, and I
actually don't do it —
PROF. GEORGE: Well, you —
DR. EPSTEIN: — you don't do it from
the economics. What you do is you derive the economics from the
socio-biology, and at that point I think the fundamentalism question
that you answer as to where people come is not economic postulates.
In fact, what is very persuasive in the
normative discourse, as you well know, is that it turns out that people
who have the pure rational choice model are the one set of people who
can't trade because they don't have any empathy.
PROF. GEORGE: So your understanding of
this thing is that you don't have a philosophical view competing
with a philosophical view. You've got a philosophical view
competing with a socio-biological account which has no philosophical
presuppositions in need of defense?
DR. EPSTEIN: Well, it's an effort to
try and solve the condition of what the definition of naturalism is,
how it is that we take these people as given. The old philosophical
inquiry is take human beings as they are and put institutions as they
ought to be, and this is an effort to find out what they are in order
to create the institutions.
And the normative criteria is a
consequentialist one with a distributional constraint, and I think once
you play that framework in there, the only way you get after voluntary
exchanges is to prove negative externalities or defects in the
transaction, and I think these are both feeble efforts to work into
those two categories, and frankly, my dear, they don't amount to
So it's not as though this is
anything you want to do by way of contract or individual choice comes
out of it. This is a real set of normative constraints on human
PROF. GEORGE: Well, I got my answer to
that one. If I could very quickly, Dr. Pellegrino, can I ask the
question I had for both or is there not time?
CHAIRMAN PELLEGRINO: Very quickly, very
quickly. This is a fundamental discussion obviously that we aren't
going to settle this afternoon.
PROF. GEORGE: It's not clear to me how
much of the dispute between our two presenters is a matter of
differences about economics and how much is a matter of differences
And so I'd be very happy if very
quickly, for example, perhaps Dr. Delmonico could say where you think
your disagreement with Professor Epstein is on economics or at the end
of the day is there not a disagreement about economics? It's
really about values. It's about ethics.
DR. DELMONICO: It's about values and
his wanting to place a market value on life. I'm not prepared to
do that, and that's just from a personal view, but neither are
these organizations, and neither was the Congress in 1984.
DR. EPSTEIN: The politic Congress has no
normative layer. I think we both agreed on that. The interesting
question is you cannot justify a system of voluntary donations unless
you have some conception that the gain to the recipient is larger than
the loss to the donor.
So you have to be in the valuation game
in any world in which there are any transactions. Whether it has to be
a market price system, who knows?
The reason why he likes to barter —
I'm going to psychoanalyze him — is that you don't have any
cash exchanged in the transaction. So you could have a mutual gain
without having a valuation question, and in fact, that is a very
powerful insight, particularly in many cases when valuation is
difficult to do.
If you could trade commensurables, right,
you can have mutual gain without doing the valuation question. Whereas
markets always require you to get enough information to set prices.
I'm all in favor of that. I just
think it's a joke to call this thing altruistic when you do them
simultaneously because of the distrust that takes place between the
pairs. There's altruism within the families and there's
bargains across families, and I don't care what lawyer he gets, I
could get him disbarred if he wrote that kind of an opinion.
CHAIRMAN PELLEGRINO: Dr. Bloom.
DR. BLOOM: You can attribute my remark
to the fact that I don't yet understand how the Council does its
business and makes it recommendations, but it strikes me that the
interchange between Dr. Delmonico and Dr. Foster strikes at the heart
of the larger problem that as long as we deal only with the supply side
of this issue all of the heroic and intellectual statements that
we've heard are not going to solve our problem.
But we can't ignore the fact that we
don't know how to do preventive medicine in that way, and to me
that's the bigger moral imperative that we have to engage in order
to deal with this as a sub-problem of that problem.
CHAIRMAN PELLEGRINO: Thank you very
I also have Dr. McHugh.
DR. McHUGH: No, I pass. Having heard
various things, I'm not going to comment.
CHAIRMAN PELLEGRINO: All right. We have
reached the end of our time, the extended time. We have had a request
for the Council members to stay for a few moments before hastening off
to lunch for a photograph. Our visitors wish to take a group
photograph. I hope you are willing to do so. It won't take very
long, will it?
(Whereupon, at 12:28 p.m., the meeting
was recessed for lunch, to reconvene at 2:00 p.m.)
SESSION 3: CHILDREN AND CLINICAL RESEARCH
CHAIRMAN PELLEGRINO: In keeping with
our attempt to stay within the program time, I think we'll begin
this afternoon session. We'll be moving from the organ transplantation
(discussion) of this morning into a different topic, namely, the
area of children's ethics, which the Council has been addressing
for several of its meetings.
In this particular meeting we'll be
emphasizing research in children and the specific problems that go with
it. Our first session will be regarding children and clinical
research, and our speaker will be someone who has worked in the field
of research and research ethics from its beginnings literally. Dr.
Robert Levine, Professor of Internal Medicine at Yale University, also
a colleague and a friend.
DR. LEVINE: Thank you for your very
laudable, brief introduction. That says who I am, and that's
I'm going to talk about clinical
research in children soon, but first I'm going to talk about
component analysis and the justification of the risks of research.
Ed Pellegrino, when he called me to come
here, asked me to talk about some of the stuff I've done
criticizing the Declaration of Helsinki, and the central feature of
that criticism that has a bearing on what you're here to do today
is the idea of component analysis. This replaces the false distinction
between therapeutic and nontherapeutic research.
I want to say right now that every
document that relies on a distinction between therapeutic and
nontherapeutic research contains errors. When we point these errors
out to those who wrote the documents, they are generally embarrassed.
It's particularly troubling when they're not embarrassed.
Incidentally, this component analysis is
relevant to research involving children. The National Commission
adopted component analysis in the course of its debates on research
involving children. That's why their earlier reports, research
involving pregnant women and the fetus and research involving
prisoners, had a number of errors. The fetus regulations were only
corrected about seven or eight years ago, and the prisoner regulations
are not corrected yet, although SACHRP is reviewing them.
Now, the next slide I will present is the
slide I prepared for presentation to the World Medical Association
Ethics Committee on the occasion of accepting their assignment to
propose a revision or to chair the committee to propose a revision to
the Declaration of Helsinki.
I said the document was illogical,
relying on this distinction; that it was out of touch with contemporary
ethical thinking, such as thinking on placebo controls; and that
finally, the document was widely disregarded and had lost much of its
authority because people were violating it as a matter of routine.
Let's take a look at two articles
from the Declaration of Helsinki as of 1996. All of the things labeled
with the Roman numeral two are under their rubric of clinical research
or therapeutic research. Number three is the nontherapeutic research.
(Article) 2.6: "The doctor can combine medical research with
professional care only to the extent that research is justified
by its potential therapeutic value for the patient."
Article 3.2, "Subjects should be volunteers, either healthy
persons or patients for whom the experimental design is not related
to the patient's illness."
Let's take these two statements and
apply them literally. What is forbidden by Article 2.6? All research
in the field of pathogenesis, all research in pathophysiology. Since
you can't justify these categories of research by therapeutic
benefit, then you must do this research either on normal volunteers or
on patients whose illness is unrelated to the protocol.
If I wanted to pursue some of Dr.
Bloom's work and study catecholamines and the pathophysiology of
depression, it would be okay as long as I studied it in people with
arthritis, but I'd not be allowed to study patients with
depression. That's what I mean by embarrassing. It rules out
What about therapeutic research?
Therapeutic research is an incoherent concept. All research has some
components that are not intended to be therapeutic. Research by its
very definition is the pursuit of generalizable knowledge, not
individual specific knowledge as we get when we're doing a
diagnostic evaluation of a patient.
Therapeutic research gives us what I call
the fallacy of the package deal. What happens is that people look at a
proposal to do research, and if they find something therapeutic in it,
they justify the entire protocol according to the standards for
Nontherapeutic components are justified
as therapeutic. I've surveyed the literature of randomized
clinical trials, and let me show you some things that were justified as
therapeutic research. Repeated coronary angiograms in patients who in
the practice of medicine would have one or none.
Repeated endoscopies in patients who in
the routine practice of medicine, patients with peptic ulcer, usually
would have none, but these were repeated once every week in order to
satisfy an FDA requirement that you really show shrinking of the
lesion. This was the evaluation of the H2 receptor antagonist.
Liver biopsies done on the place by group for no reason other
than to maintain a double blind. Placebos administered into the
coronary arteries, that (were part of) the National Heart, Lung
and Blood Institute's TIMMI protocol evaluating various clot
dissolving agents in the treatment of people with myocardial infarction.
Now, component analysis is different. In
component analysis we don't evaluate the entire protocol as
therapeutic or nontherapeutic. We evaluate individual interventions or
procedures. Here is the language taken from the regulations on
research involving children:
"Interventions or procedures that do
or do not hold out the prospect of direct benefit for the individual
Beneficial procedures are justified as
they are in medical practice. The risk is justified by the anticipated
benefit to the individual subject. It's required that the
relationship of anticipated benefit to risk be at least as favorable as
that of any available alternatives.
I've already mentioned what we do
with beneficial procedures. The only limit is the anticipation of
personal benefit. In nonbeneficial procedures, however, we have
prescribed limits, thresholds, what sort of justification does it take
to expose child subjects to increasing levels of risk?
For example, if there is a minor
increase over minimal risk, the procedure that presents this minor
increase must be reasonably commensurate with those in the actual or
expected situation of the child. The anticipated knowledge must be of
vital importance to understanding the subject's disorder or
I don't know how many of you have
read the case study for tomorrow, but this will afford you an
opportunity to figure out what it means when it says
"subject's disorder or condition." Just what is a
disorder or a condition?
The subtitles in Subpart D are enormously
confusing. A little bit of history. When the National Commission
finished its report on research involving children, it turned it over
to what was then called the Department of Health, Education, and
Welfare. The regulation writers produced a set of proposed regulations
based upon this report.
The National Commission said, "No,
you've got it all wrong," and made them go back and develop a
new proposal, and then the National Commission went out of office. So
the new proposal came out faithful to the National Commission's
report, but the subtitles were written after the National Commission
went out of business, and so the subtitles restore therapeutic
Research involving greater than minimal
risk but presenting the prospect of direct benefit, and then the text
says "interventions or procedures that do or do not hold out the
prospect of direct benefit."
Unfortunately, too many people working in
the field of research ethics or an IRB administration seem to have only
read the subtitles. They haven't gone to the finer print that is
actually the regulatory standard.
Now I'm going to shift to a more
explicit discussion of research involving children. I'm going to
talk about some general considerations that are problematic in
designing and reviewing research involving subjects, including
children, and then I'll offer some considerations that are specific
General considerations. Ever since the
Office of the Inspector General asserted that IRBs are overly burdened
to the extent that they can't get their work done, this has been a
topic of conversation that's near the front of all conversation on
research review. I agree that they're overly burdened. That's
beside the IRBs are required to do things that don't need doing.
They're required to do periodic, usually annual, review at convened
You can't imagine the number of
adverse event reports that come across the desk of the IRB
Administrator. There is no reason in the world for a convened meeting
to review all of these things. This is something that should be done
by the Data and Safety Monitoring Board, which has the advantage of
reviewing all of the data and it also knows the denominators for the
data, where all the IRB gets is a lot of disconnected reports that
probably belong in the numerator.
Review of — I beg your pardon. I just
discussed the second bullet. The first bullet, periodic review at a
convened meeting. This is also a meaningless exercise. Usually at the
first anniversary of a protocol the research has not even begun yet.
You're still waiting for the study section or the Council to decide
whether you're going to get your money.
But even after it has begun, there's
usually nothing that requires the attention of every member of the
committee, and finally, documentation that all regulatory requirements
were considered. If you review the list of observations that OPRR first
and now OHRP came up with in those universities where it closed down
the research operation until they got their IRB system straightened
out, these are the three things that are most frequently mentioned.
What do I mean by documentation that
regulatory requirements are considered? The way this plays out in real
life is that you have to say if research involves children, we have
made a determination that the risks are not minimal. They're a
minor increase above minimal risk. We have made a determination, and
you have to essentially repeat each of the regulations as you say,
"Yes, we did that. Yes, we did that."
By analogy, it's like every time you
stop for a red light writing a report saying, "I did not go
through the red light," the behavior should be sufficient without
all of this documentation.
What I have come up with is a proposal
for modified expedited review. I would have each of these categories
of activity carried out by an experienced member of the IRB not to
approve or disapprove, but to see whether or not this crosses the
threshold of requiring attention of the entire IRB at a convened
This person would not necessarily have
the authority to say this is okay or this is not okay, but rather to
say this should be reviewed by the full meeting.
We don't have much empirical
information on this, but we have sort of an informal empirical study.
Norman Fost, who has been involved in this business almost as long as I
have at the University of Wisconsin in Madison, took 3,000 consecutive
protocols that required periodic reapproval. He reviewed them
according to the old method, that is, having expedited review with one
expert member looking at the protocol and deciding what, if anything,
ought to be changed before they issued reapproval.
He then took these 3,000 consecutive
protocols and turned them over to the fully convened IRB. The number
of cases in which the convened IRB made substantive further revisions
was zero. That's what I mean by doing things that don't need
to be done.
General considerations. Two,
"waiver of the requirement for consent, assent and
permission." The standard that's represented in the
regulations says that the research could not be practicably carried out
without such a waiver. We need to have some authoritative statement on
what "practicably" means. Some policy makers and some policy
enforcers have seemed to believe that means without the waiver of the
requirement for assent or permission it would be impossible. Medical
record review is customarily done without individual consent, assent or
permission. Nobody seems to have their rights violated by this or
interests, if you can keep things adequately confidential.
It's not impossible to get informed
consent to review medical records, but imagine going out, having the
investigator go out and contact sometimes 1,000 or more patients to get
consent for looking at the medical records.
The standard minimal risk is the trigger
of many regulatory requirements, particularly the trigger for waiving
or altering some of the requirements of the regulations. We use this
standard to waive the requirement for parental permission, and we use
this standard to justify risk in terms of anticipated benefits.
Minimal risk: What does it say in the definition of minimal risk?
It says two things. One is that the risks are like those in everyday
life, and it says the risks are comparable to the risks of a routine
medical or psychological examination.
Now let's see how these are applied
to children. Many IRBs around the country say that if a child is going
to be exposed to sexually explicit language, this is greater than
minimal risk. I think that people who are experienced in talking with
children know that they generally already know about language that
would shock the investigators. I would say this sort of thing should
rarely be considered more than minimal risk, given all of the
additional things that the investigator would have to do.
What about the risks of the routine
medical examination? The routine medical examination, as most of you
know, consists of a deep probing into one's family history, a deep
probing into one's social history, looking for all sorts of
behaviors that might have a bearing on one's health or on making
It's my belief that as we interpret
whether or not the procedures in a given research protocol go beyond
the threshold of minimal risk, we should keep in mind what goes on in a
routine medical examination. The OHRP not too long ago reached a
determination that if you asked the subject to give sensitive
information about their relatives, you not only had to get consent from
the subject, but also from the relatives.
This is what I call regulatory excess.
The problem is not in the regulations. The problem is in how those who
are responsible for implementing the regulations interpret them.
The assent form, you know, the purpose of
consent is to empower the prospective subject. You give them
information, and they develop the capacity to protect their own
interest through consenting or withholding consent.
The purpose of documentation, by
contrast, is to protect the investigator and the institution. If the
subject comes back a year later and says, "You did not get
informed consent from me, you didn't tell me I had a right to
refuse," now you can pull a document out of your desk and say,
"I not only gave you that information, but I've got a signed
receipt for it."
Why then do we need assent forms? Why is
so much energy put into developing assent forms? The child is not
going to come back and litigate. I believe the main purpose of the
assent form should be to give the child the sense of participation.
Just like the parents sign a form, let the child also sign a form, but
don't get so preoccupied with developing the sorts of assent forms
that serve as perfect analogues for the consent form.
Final slide. Research involving
adolescents. I knew that I'd be getting to the end of my time
allotment now. So what I simply said is in recommending policy for the
future, one should pay attention to the guidance of the Adolescent
Treatment Network's Ethics Panel. This is a panel established
within the National Institute of Child Health and Development.
It recognizes the emerging autonomy of
adolescents. Adolescence is just one example of how we, as a society,
have painted ourselves in the regulatory corners. We develop rules
that described how you could involve children in research, and then
some years later we discovered that adolescents with HIV infection
would have to go through enormous hassles in order to comply with these
rules when what you really wanted to do is give these adolescents the
treatment of choice, which often included a drug on investigational
We've done the same thing through
ourselves with prisoners. I could give you examples in many other
categories, but today's assignment is children.
Now, I wanted to stop here or I proposed
to stop here, but I told your leader, Ed Pellegrino, that in case
anyone was not familiar with the Adolescent Treatment Network's
recommendations, I have a few extra slides I can show you. I said I
would ask if the group was interested. He said, "Don't ask.
DR. LEVINE: So what I'm going to try
to do now — oh, my God, what have I done? Help.
As you can see, this is a talk that I
really designed to give in Singapore a few years ago, but here it is.
Self-authorization by adolescents to
serve as research subjects. The default position in the Code of
Federal Regulations is that adolescent's assent requires parental
or guardian permission unless either the minor is emancipated or the
IRB finds that permission is not a reasonable requirement, for example,
in studies of abused or neglected children.
This is an inadequate position, and
without getting into all of the reasoning, I'll now end. There
must be an appropriate mechanism to protect subjects to substitute for
the protection usually afforded by permission, and this is the passage
in the regulations that the adolescent treatment network picks up on.
The waiver may not be incompatible with any laws.
Now, under what circumstances is
permission not reasonable? First, the one that's mentioned in the
Code of Federal Regulations says that the children are neglected or
abused, but the National Commission mentions some other circumstances
in which it would not be a reasonable requirement.
Research on diseases or conditions for
which adolescents may obtain treatment without parental permission, and
that's quite a number of disorders, many of which are the target of
Minimal risk research involving mature
minors and children who are designated by their parents as in need of
Parents are legally or functionally
The waivers that are permitted by Subpart
A, and that is the general regulations for all people who are research
subjects, and the regulations on children explicitly reference Subpart
A to say here are the standards for satisfying the regulatory
justification for waiving the requirement for consent: no more than
minimal risk. The waiver or the alteration will not adversely affect
the rights or welfare of the subject. The research could not
practically be carried out without the waiver. I've already
commented on that one, and whenever appropriate, there would be
debriefing or dehoaxing or the sorts of things that are characteristic
of research in psychology when you are not given full information at
I've already said something about
minimal risk. So I'm not going to repeat it here. Even in
Singapore I talked about the medical examination, probing the most
Now, here are the recommendations of the
Adolescent Treatment Network. First, Category 1 research consists of
anonymous surveys and other research in which there is no risk
whatever. They say you need not consult the parents in this type of
Category 2 is research with any risk of
physical, psychological, or social injury.
And Category 3 is research involving
investigational new drugs or other FDA regulated test articles.
In Category 2, in which there is some
risk but no test article, they want to encourage and assist the minor
to obtain parental involvement. If I may digress for a moment, much of
the discussion until the Adolescent Treatment Network got in on this
had a tendency to alienate children from their parents. You would come
to the child and say, "We don't have to get your parents'
permission. You can authorize this on your own."
And what ATN is saying: no, encourage
them. A lot of them would be well served to discuss their issues with
their parents, but don't insist.
B, the upper limit for risk of
nonbeneficial procedures is minimal unless greater risk is justified
according to the standards in the Code of Federal Regulations. And I
mentioned those, the procedures commensurate. There's a minor
increase above minimal risk, things of this sort.
Category 2 continued. They would like to
see in any project that carries out research presenting risk to
children or adolescents develop a structure through which they can get
consultation with the community. They would like to have a community
board that would be overseeing this research to provide advice,
criticism, and let them know what is and what is not acceptable.
If I went to them and said,
"It's okay to use obscene language in a consent form," in
some communities they would say, "Yes, we know the kids know
this," and in some they would say no.
Here's a crucial point. The minor is
already obtaining health care services either independently or with
parental permission, and the research is being conducted in conjunction
with such health care services. There are many adolescents who have
the go-ahead from their parents to get medical care at a certain
institution without reporting on each and every component of that
medical care. This is what the Adolescent Treatment Network is talking
Now, thirdly, research involving
investigational new drugs. A, just like before, "encourage and
assist minor to obtain parental involvement. Upper limit of
nonbeneficial procedures is minimal. Community consultation and
continuing involvement. The minor" — this is just like Category
2. Here's where we began to see a difference.
There should be an advisor or an advocate
appointed for each individual patient subject. This is very
important. One obstacle to having many adolescents get involved in
trials of new treatments or diagnostic procedures is that they simply
don't want to tell their parents, "I need treatment for drug
abuse. I need treatment for HIV infection."
Many of the researchers say if we
insisted upon parental permission or guardian permission, this would
devastate our chances to do research in this population, and so I think
this is a pretty good set of recommendations. I was part of the — I
still am part of the Adolescent Treatment Network. So what I'm
really doing is hawking my own product to some extent, but I hope you
will also find it reasonable and perhaps take some action on it.
I apologize for the fact that you
don't have it in your handouts, but it's in the
President's Council's computer, and you can make handouts as
you see fit.
Thank you very much for your attention.
DR. LEVINE: I would like to respond to
your comments or questions, and I'll even sit down if somebody
would shield that projector.
CHAIRMAN PELLEGRINO: Thank you very
Dr. Levine's presentation is open to
commentary and questions. Any member of the counsel who would like to
being the discussion?
DR. LEVINE: It's unprecedented that
I could talk for 30 minutes and not create some confusion.
CHAIRMAN PELLEGRINO: Or to be so
convincing. I don't see any body language that indicates an urge.
Maybe it's the luncheon period.
Thank you very much.
Well, Robby George and Dr. Bloom.
DR. BLOOM: Bob, you talked about
unnecessary documentation for the research protocols. Does the same
apply to the HIPAA regulations in terms of child research?
DR. LEVINE: You have to follow HIPAA
regulations when you're doing research on children as well as
adults. The HIPAA regulations are, I would say, in a majority of
protocols, not an undue burden for the individual researcher and not an
undue burden for the IRB. They are burdensome in other respects, and I
wish something could be done to tend to that.
Now, what has happened though is that
there has been some what I consider inappropriate use of HIPAA
regulations or HIPAA type requirements. I will give you a recent
example that I was consulted on.
There's a group of epidemiologists
who want to do research in the State of Connecticut looking into
certain patterns of distribution and risk exposure for various types of
cancer. We have in the State of Connecticut a state authorized tumor
registry. That means information goes into the tumor registry on every
patient who has cancer, and this is done without consultation with the
patient. It just goes there. It's automatic.
And the state regulations say that
researchers, bona fide researchers — they have to present some bona
fides — will have access to this. However, in the HIPAA era some of
the IRBs in Connecticut, indeed, a majority of the IRBs in Connecticut
have said, "You can't look at that information without the
authorization of the patient's personal physician." That is
bringing the whole program to a halt.
The problem is not necessary with the
laws of the regulations. The problem is the way they're
interpreted. Now, the thing that precipitated their consulting me is
that they got information out of a record of a woman with breast
cancer. There was a follow-up study which showed that she had the
genes that would predict a high likelihood of developing additional
breast cancers in her and her family.
They wanted to contact this woman, and
the IRB said no, not without the permission of the private doctor. The
private doctor did not give permission, and wouldn't you know it?
Four or five years later she developed another breast cancer.
So this is not the main reason to
authorize access, but it's just one of the aspects of unintended
adverse consequences of interpreting these regulations.
Thank you for your question. It would
not have been better if I had planted it.
CHAIRMAN PELLEGRINO: Dr. George.
PROF. GEORGE: Thank you, Dr. Levine, for
I wonder if you could clarify for us... a concept that I thought
appeared in one of your slides, and that was the concept, if I have
it right, of emerging adolescent autonomy. Have I captured the
DR. LEVINE: I think you quoted it
PROF. GEORGE: Now, is that a concept that
concerns an individual adolescent and like all adolescents an emerging
control both in terms of ability and in terms of permission of family
and larger society about decision making or is that a social concept?
Is it a concept about the way in which there has been a shift toward
permitting adolescents to have more freedom?
And then once that is clarified, do you
regard it as a purely descriptive concept or is it a concept for the
purposes that you had in mind that has some normative content, that it
should guide policy decisions one way or another when it comes to
research involving adolescent children?
DR. LEVINE: The answer to your last
either/or question is I intend both, but let me go back a little bit.
We already have a national policy which recognizes the emerging
autonomy of all people under the age of 21. We recognize that there is
no autonomy in the infant.
The National Commission's
recommendations said that you have to get assent, but in the age range
before assent becomes meaningful, children can register what the
National Commission called a deliberate objection.
A four year old, for example, not every
four year old, but an individual with cognitive development of the
typical four year old can't really understand the abstractions that
go into giving assent, but they can be told, "We want to draw your
blood, and you know, all these other times that we draw your blood you
have to do it because it's for your own good, but this one is not
for your good. It's for the good of other people."
And a four year old can say, "Well,
if I don't have to do it, I'm not going to do it." That
is not assent, but that's what the commission called a deliberate
objection. It didn't appear in the regulations, but most IRBs
Now, what we have from the people who
study the development, child development, is we've got some
milestones. At about the typical cognitive development of a typical
age six or seven, we first begin to see the capacity to engage in some
of the sort of thinking that goes into giving consent or assent.
The six or seven year old can easily
comprehend, "You don't have to do this." They can easily
comprehend, "If you do this, it will hurt." But they're
not going to be able to respond to other regulatory requirements like,
"In case you get injury, there will be no compensation or
disability." So six or seven was one milestone.
The next milestone that was offered was
about the age of 11 when they could begin to engage in certain sorts of
abstract reasoning that would embrace such things as altruism and so
on, and by the time they're 14, probably, if my memory serves — I
learned this long enough ago that I do remember it — at about the age
of 14 they're able to go through the processes, the components of
consent as good as any adult, as well as any adult.
Between 14 and perhaps 18, 21, even
though they can go through all of these maneuvers, what they lack is
judgment. They don't have a mature judgment. Even though they can
go through all of these maneuvers, many 16 to 19 year olds have not yet
grasped the idea that they, too, might not be immortal, you know.
So, yes, we already have policy that
recognizes all of this stuff, and we spin off concepts like mature
minors. There's another category called emancipated minors. I
think these sorts of things should be brought up as we're
considering what sort of assent we're going to require in any
I think also that there are some
protocols where you might say, "We're not going to give you a
general rule here. We want you to interview each child to see whether
or not this particular child is capable of independent decision
And in the case of the ATN, the
Adolescent Treatment Network, in certain types of work, particularly
the evaluation of FDA regulated test articles, they want to make sure
that you've got an individual counselor for each child that gets
involved in this, and the main target of that is to help supplement the
immature capacity for judgment.
It may or may not interest you to know
that when the federal government first issued its proposed regulations
for research involving children, it took no position on when children
could assent. So it asked the public in the public comment period to
help them. They asked either seven or 11 or case-by-case determination
by the IRB, and the case-by-case determination is the way it finally
That may be more than you were asking.
PROF. GEORGE: No, I have more to ask.
DR. LEVINE: Oh, okay.
PROF. GEORGE: Actually it's very
helpful. I just want to follow up so that I can learn more about it.
So far as the concept is descriptive and
within obvious limits, are the milestones strongly socially
conditioned? In other words, if we studied different cultures would we
find the milestones at about the same place as at six and 11 and
possibly then 18 to 21?
And then secondly, within our own culture
or generally if there isn't strong cultural conditioning, are there
significant milestone differences between the sexes?
DR. LEVINE: Oh, my. First, let me say
you've just taken me beyond the bounds of my competence, but
I'm going to answer anyway.
What you'll find is that social
perception varies around the world. In my work in developing
international documents, I have found that the age of consent, the
lowest age of consent I've seen specified in national legislation
is 12 and the highest is 21. So to the extent that the regulations or
the law of a society or of a country reflects social attitudes, there
is quite a bit of variation around the world.
I think also the concept of autonomy
doesn't work very well in many parts of the world. So it's
really — I mean, I can capture it in one epigrammatic statement. At
one of our meetings to develop the SIOMS guidelines, there was a
Francophone physician from Central Africa who said, "You know, in
your part of the world you've got a saying, 'I think.
Therefore I am,'" which I thought was really French. He said,
"In my part of the world the saying is, 'We are. Therefore, I
The idea of self-determination in many
parts of the world is considered antisocial behavior. Even in Europe,
even in like Norway the expression is anyone who tries to rise above
the crowd, we hammer them down like a nail.
PROF. GEORGE: I'm certainly not
surprised that there would be differences in regulation in different
cultures, and it seems reasonable to assume those would reflect
different perceptions of ability, but I guess what I was really
interested in was the deeper question — and you just might not know
the answer to it, but if you do I'd be curious to know what the
answer is — whether there are actual differences from culture to
culture as to the age at which certain capacities truly do manifest
So, for example, would the capacity for
abstract conceptual thinking be about the same everywhere or might it
be different, you know, in Tibet than in Norway or in Albania?
DR. LEVINE: I don't know. I can
tell you though you asked also about gender differences. Based upon my
totally vicarious experience of research in child development,
contrasting, for example, the account of child development of Kohlberg,
say, with Gilligan, whether or not people are capable of abstract
reasoning at any particular developmental level depends entirely on how
do you study them. What do you ask them to do, right?
So I think somebody who follows the
Kohlberg model, as so many people who did follow the Kohlberg and his
predecessors' model, said that females are, in general, a case of
arrested development. All right? That's because they hadn't
internalized all of these abstract principles.
And if you read the work of his student,
Carol Gilligan, you get a very different vision. You know, so with
that lurking in the background, I just don't know how to answer
PROF. GEORGE: A final question that's
DR. LEVINE: Okay.
PROF. GEORGE: And perhaps I was
misinterpreting a different slide, but was there in one of the slides a
category of anonymous surveys or anonymous questionnaires which were —
DR. LEVINE: Yes, that was the ATN's
PROF. GEORGE: And these are regarded as having no
DR. LEVINE: No risk.
PROF. GEORGE: And why would that be? It
seems to me it wouldn't be — I can imagine plenty that
wouldn't have a list, but I can't imagine saying, you know, in
a kind of universal way that there would necessarily not be risk.
Certainly some surveys I wouldn't want my daughter to be filling
DR. LEVINE: Let me say that one of the
badly abused words in our university environment is
"anonymous." Many people think it's anonymous if you
don't put the patient's or the subject's name in the same
place that you put the data, but when ATN talks about anonymous, they
mean really anonymous. There is no way to reestablish the link between
any personal identifier and the individual subject.
Now, they are talking about utterly
anonymous research like going into the medical record room and taking
out demographic or other data with no personal identifiers attached,
and you have a data set. Use of that data set would conform to their
Category 1. There is no way to link any information to any individual
By the same token, if you ring up the
clinical laboratory in a hospital and say, "I want all of your
leftover specimens of blood," you would send a lot of blood. If
they asked you to do electrolytes and stuff like that on it, any that
you haven't used, give to me. I'm doing research, but I
don't want any identifiers of any sort or even you might say,
"Give me only the blood from those who had high blood
sugars." This is still anonymous.
This is what they're talking about.
Now at the time you're interacting with the subject, at this time
the things that are going — I mean you can't be anonymous when
you're actually interviewing somebody. So you might then say that
there's some aspect of this interview that would rise — that could
be considered a risk of injury of some sort, social injury, physical,
whatever. Then it would come out of Category 1 and move into Category
PROF. GEORGE: I was concerned about
matters that would go beyond anonymity. It seems to me reasonable for
parents to think there are some questions they don't want their
children to be asked about or confronted with, some matters they
don't want their children to thinking about. It could be for moral
reasons. It could be for religious reasons. It could be because they
think that the reflection on that could lead them to behaviors that are
dangerous for them and so forth, just the asking and reflecting on the
So it seems to me that the content of the
questionnaire itself no matter how comprehensive the anonymity could
create what could reasonably be interpreted by parents as the risk of
harm. Is that not so?
DR. LEVINE: Sure, and it's precisely
for that reason that the ATN wants you to have community consultation
and community advisory boards, to help you out with that sort of —
PROF. GEORGE: So there would be an
evaluation in the ideal circumstance, an evaluation by some community
board of the appropriateness even of an anonymous questionnaire —
DR. LEVINE: Yes.
PROF. GEORGE: — because there would be a
recognition that even an anonymous questionnaire could create risk.
DR. LEVINE: Exactly.
PROF. GEORGE: Okay.
DR. LEVINE: And you know, the
regulations say the community representation in evaluating proposals to
do research may be limited to one member of the IRB who has no
connection with the institution, apart from membership on the IRB.
But what ATN and the whole AIDS treatment
program, AIDS clinical trial group, what many of these programs are
doing even for survey research is going far beyond that and saying we
don't want just one member who could be outvoted or outnumbered.
We want a whole community advisory group.
PROF. GEORGE: Sure, and that would mean
that, for example, the idea of parents' rights when it came to
questionnaires for children could be a matter that would have to be
DR. LEVINE: It could be, yes.
CHAIRMAN PELLEGRINO: Dr. Meilaender.
DR. MEILAENDER: Yes, Dr. Levine. Two
questions. One I think is just sort of very focused, and the other,
The narrower one. I think there's a
sort of puzzle that folks who aren't regularly involved in this
have when they think about this whole set of regulations, and I have to
admit it puzzles me sometimes, too. On the one hand, it looks as if
you've got a very developed, clear set of regulations that tell
you what to do, but then, on the other hand, you get a concept like
minor increase over minimal risk, and it's very hard to know what
that means actually or why we should share a notion of what it means.
And so I would just welcome anything you
had to say about clarifying a concept like that. That's the narrow
The larger one is related more to stuff
that was just in the reading we've given and specifically to what
you've said here, but just that general question that, of course,
has been around for a long time that you take up there about whether
our primary concern in developing a whole regulatory system should be
protection of potentially vulnerable subjects, which protection might,
in a sense, deprive them of some benefits of participating in research
or whether or not primary concern should be, as it were, making sure
that the benefits of participating in the research are available to
I took you — I'm not sure whether
rightly or not — right near the end of the reading we had to opt to
tilt in the direction of allowing to profit from the benefits of it,
which even if true, I mean, one might raise a question about whether
that's the right tilt in the case of a group like children, for
And so I would just on that issue, too,
appreciate a little more talk from you about what you have in mind.
DR. LEVINE: Two good questions. Let me
deal with them in order. What do we mean by a minor increase above
When this criterion was written by the
National Commission, it was conceded that no one really knew for sure,
but what we thought would happen and what did happen is that we have
developed sort of an analogy of common law, what I call a common sense
of the community.
As one case study after another has been
published on how are IRBs reaching these decisions, and as they go
together and have their IRB meetings, usually the largest ones are
under the rubric of the annual PRIM&R meeting, Public
Responsibility in Medicine and Research, and they share their
experiences, we're beginning to get a pretty good idea of what most
people consider a minor increase over minimal risk.
Minor increase is one of a — the term
"minor" in this case is what some philosophers will call a
dispositional characteristic. A dispositional characteristic is
something that suggests a category. In the law we have the reasonable
person standard. Some people say, "I want to pin it down. What
is a reasonable person?"
Well, you know, in England its the man on
the Clappam (phonetic) Omnibus or something like that. If you pin this
down, if you freeze it in one place, it loses the usefulness of a
dispositional concept, and you have to invent a new term to cover what
you were talking about.
The example that the philosopher who gave
us this concept, Royal, used was elastic. I say "elastic,"
and you know what I'm talking about. What if someone comes in and
says, "Elastic means that a six inch rubber band will stretch no
less than one inch and no more than two inches"? All right. Now
you've got a satisfactory stipulated definition of elastic. You
have to invent a new term to cover the full range of what you really
wanted to talk about when you said "elastic."
I put reasonable, minor increase, things
like that into this dispositional category. I think the way we kind of
evaluated it is as an IRB is sitting and making a judgment about what
is a minor increase, they ought to be thinking about what about other
people on other IRBs. Will they consider our judgment reasonable
within the boundaries of what we ought to be permitting?
And that's the main touchstone they
have for evaluating things of this sort. That's your first
question. Is that satisfactory, or you want me to do better or do
Now, what about —
DR. MEILAENDER: Maybe you could do
better in one way. Just examples of. There was an example in the
reading somewhere that you gave us of bone marrow examination or
something like that for somebody who already had it. There was an
example that Loretta Kopelman gave years ago in an article about the
kids in I think it was the human growth hormone study and the various
things that they had to do yearly, I believe, that just to the ordinary
lay person might sound like something you'd call more than a minor
increase over minimal risk or examining my bone marrow. Even if
I've had to have it done a few times for medical reason might sound
How do we know that the case law
developing among IRB people reflects what just sitting in probably a
less informed way in my living room I might say, "Well, that
doesn't sound like a minor increase."
I do think there's still a problem
about cases there.
CHAIRMAN PELLEGRINO: Well, Loretta Kopelman wrote
her critique of that study. This was a study that had to do with
giving human growth hormone injections to children who were short for
their age but had no disease. They did not have human growth hormone
deficiency. In order to give this stuff, in order to evaluate this
stuff, you had to give half the group the growth hormone and you had to
give the other half placebo, and this was administered, I think, by
subcutaneous injection. Do you remember?
And blurring the two, the other one was
the papilloma virus vaccine that had a very similar argument and
structure. One or the other of those protocols required that you give
these children, eight, nine year old children, two subcutaneous
injections a week for a year and a half.
And Loretta and some others thought it
was unduly burdensome to give a child two subcutaneous injections of
placebo for a year and a half, and so she was part of a committee that
was assembled by the National Institute of Child Health and
Development, and they reviewed this protocol according to what we call
Section — what is it? — 407 maybe of the Subpart D, which is
something that meets when you're proposing to do something that
presents greater than a minor increase over minimal risk. It requires
a full review under the requirements of the Public Advisory Committee
Act, and so on.
And they conducted this review, and
Loretta was outvoted on it. This is going to happen. I was not a
member of that group. So I was not privy to all of the arguments that
were presented, but I could see that she had a good point to make
Let me get to your other question. There
is a tension always between protecting prospective research subjects
from harm and developing knowledge of products that will be of benefit
for these subjects. There is always a tension, and if I wrote the last
part of my paper, which incidentally is in Loretta Kopelman's book;
if I wrote the — I think I called the last few paragraphs the
epilogue, and if I came out suggesting that I think that developing
benefits should always triumph over protecting subjects' rights
and welfare, then I did a poor job of writing that epilogue.
I think that they should always be in
tension, but what I have to say though is when protection was the
dominant approach to evaluating research involving children, we
developed what the National Commission recognized as a class
injustice. Just because these children were unable to consent, we
protected them. We kept them out of research, and from 1962 until the
time the Commission was meeting, only two drugs had been approved that
had been evaluated in children to the extent that you could say here is
our advice on dosing. Here is maybe the children are more or less
Why do I pick '62? Because that's
the date of the Harris-Kefauver amendments to the Food, Drug and
Cosmetic Act. Before that time, you did not have to show a drug was
effective in order to market it. You just had to show it was safe.
And so this was not a problem, but as
soon as you call for efficacy, that means you're calling for
clinical trials. That means if you don't involve children in the
clinical trials, you can't provide advice in how to use the drug.
Now, this, I think, I agree with the
Commission that it was a class injustice. So I think as we review each
proposal to do research on children or any other vulnerable population,
we have to be aware of the fact that we're balancing protection
I mean, women got an even worse deal out
of the '62 amendments. For many, many years nothing was approved
because they ruled out — I hate this expression, but it's what the
— women of child bearing potential. One woman said much has been made
out of children becoming the therapeutic orphans, but just like
children, we as women are being, and I quote, "protected to
death." Wish I could have thought of that.
CHAIRMAN PELLEGRINO: Dr. Schaub.
DR. SCHAUB: Robby covered the questions
I had. I should go on record with that. Robby covered my question,
and it was about anonymous surveys.
CHAIRMAN PELLEGRINO: Thank you.
DR. KASS: Well, Bob, two questions.
Less about the presentation, but more about your sense of the state of
things with the ethics of governing research using children.
If I'm understanding what's in
the documents that you presented and the talk you gave here, certain
misconceptions of previous formulations have been in the process of
being corrected. The principles seem to be well articulated. The
problem seems to be kind of excessive burdens on the IRBs owing to not
so much wrong principles or wrong law, but slavish excess addressing of
questions that one ought to be able to expedite.
(a) Is that — let me do it sort of
piecemeal. Is that a correct assessment? I mean is there
intellectually as opposed to making the system run more efficiently —
are there large intellectual ethical difficulties that you think need
further addressing or have the people like yourself who have been
working valiantly in this field for now 30 years or more, have you more
or less gotten these things well in hand?
I made it difficult for you by giving you
some praise in the course of the question. I don't mean you to be
embarrassed by this. As a person who studied this, do you think that
we really have the ethics of using children as research subject more or
less in good shape and that the problems are simply the refinement of
the applications in the IRBs?
DR. LEVINE: I don't see us making
much progress in developing the underlying ethical arguments or
underlying, if you will, theory with regard to involvement of children
as research subjects.
I think what I see now is a turn toward
excessive bureaucracy, excessive attention to pointless detail, and
I'm going to mention why I think this is happening in a minute.
I think that in ethics generally, the
ethics of research involving children was largely formulated in the
1970s, very little by way of advance since then. And the ethics of
research involving children is very much the ethics of the 1970s. Some
people sneer and call it principalism, but it's very much in that
But if you look at the purpose of
regulations, there's something that would have to be enforced by
bureaucracies, and you can't get into some of the other types of
ethical reasoning that seem to me much more attractive, such things as
narratives, such things as what Gilligan would call the care oriented
framework as distinguished from the justice oriented framework.
I think I would like to see that sort of
ethics become the cornerstone of discussing the ethics of pediatric
practice or, for that matter, all medical practice.
I wrote a paper somewhere in the 1980s
called "The Teaching of Medical Ethics, Contrast Between What We
Want and What We Teach." Everyone wants caring physicians, but
we've set up all of our teaching of ethics to create great
obstacles to the caring physician.
So I want to see pediatrics; I want to
see the ethics of medicine going in a different direction, but I
don't see the ethics of research going that way because in the
practice of pediatrics, practice of medicine, you're mostly talking
about a relationship that can evolve and develop over a period of
years, and the researcher, it's not so bad to have what Tolman
would call an ethics of strangers for the researcher-subject diad.
They are, after all, strangers.
The research defines what he or she wants
to do for a certain we call it sample size, and people who meet the
entry criteria come in. They relate to each other until they have
completed their mutual purpose, and then they go their separate ways.
An ethics of strangers seems okay.
Not so for the doctor-patient
DR. KASS: May I continue?
DR. LEVINE: Please. Oh, one thing I
didn't do, Leon. You asked me to say how did it get this way. Do
you want me to do that? Why are we so bureaucratic now?
DR. KASS: Maybe a couple of words on
that would be useful actually.
DR. LEVINE: That's one of my
favorite topics. In the 1970s and 1980s, IRBs — in the '60s even
— IRBs were there to look after the rights and welfare of the
patients. They were very informal. The IRB at Yale New Haven Medical
Center was created in 1961.
I became chairperson in 1969. The first
protocol that has a number and a file is 1969. It was very informal in
the old days.
During the '60s, '70s, almost all
IRB chairs around the country were clinical pharmacologists. In fact,
most of them were the folks who trained in the same lab I did, and
that's because clinical pharmacologists are generalists.
They're not looking at one drug. They're looking at all of
these drugs, and development of drugs was seen as a major theme in
And then in the aftermath of the National
Commission, more and more of this was taken over by regulatory
oversight. Still the system functioned fairly informally with good
people trying to do good things until the time that what used to be
called OPRR, the Office for Protection from Research Risks, began to
get rather heavy handed in making site visits to university research
operations and closing them down.
Well, before that time, the people who
were running the IRB were people who were devoted to doing this and had
a pretty good knowledge of the field, the relevant ethics and
regulations and so on, not that everybody on the IRB knew all of the
ethics, but every IRB had somebody who did and could explain things to
What happened when OPRR began closing
institutions? It got the attention of the provost. Now, the provost,
until the '90s, people would say to me, "As IRB chair, who do
you report to?"
And I would say, "The Dean."
But the way the Dean knows I'm doing
a good job is that he never hears my name. It's not a formal
reporting. I didn't walk in once a week and say, "Here's
what we did last week." But maybe once a year I would chat with
the Dean and say what we're doing.
But any time he heard my name in the role
of IRB chair, apart from schedule, this was probably because somebody
was irritated about what we were doing.
Now what we have is the provost moves in,
and the provost reads the list of observations made by OPRR when they
closed Duke University, when they closed Rush Medical Center, when they
closed Johns Hopkins twice, and they would read all of these things.
In fact, somebody collected all of these observations and counted them
up and published them in the Annals of Internal Medicine.
Number one, doesn't do periodic reapprovals at convened meetings.
And the provost, not knowing anything about the field, says, "That's
important. That's the most common observation they made here."
And so from then came this drive toward
meticulous responsiveness to everything OPRR ever wrote in an
evaluation letter. All right?
I think also the public is getting
concerned the way it did in the early 1970s when we had Tuskegee and
Willowbrook, you know, Jewish Chronic Disease Hospital. Anyone in the
research ethics field can kind of recite all of the classic cases of
Now what we're getting is reports by
the Office of the Inspector General saying the IRBs are doing a bad job
because they're overburdened. We're getting all of these
stories about closings of university research operations, and we're
getting just like Tuskegee, we're getting the Gelsinger case. All
right? We're getting the Kennedy-Krieger Institute in Baltimore
led exposure. We're getting the CHEERS study from the
Environmental Protection Agency, and there's a lot of scary stuff
that's being put out there.
But, once again, the public is not
getting a full account of things. They are not seeing the
denominator. You know, for every case you hear about, there's
10,000 you never heard about.
Enough. I think I've made my point.
So I think the pendulum of public opinion
is swinging back toward where it was in the '70s.
DR. KASS: Yeah, I don't want to
preempt comments from others, but could I just follow up? Is there in
your opinion something that you would urge upon this Council to do in
And part of the answer to that is is
there not a group at NIH who is working on development of some further
refinements along these lines to deal with the overburdening of the
IRBs and things of that sort?
But in general, this morning we were
treated to strong recommendations as to what this Council should or
should not say in order to solve a major problem. I'm wondering
whether you have not so much a strong recommendation for a conclusion,
but a strong recommendation for a piece of this subject that you think
deserves the attention of this particular body, or is this something
that the field itself is going to be able to work out on its own?
DR. LEVINE: Leon, I have not gathered my
recommendations into the form of an overarching recommendation of
here's what you ought to do, but given the opportunity to say
something now what I would do is ask the Council to take steps to reel
in this runaway bureaucracy; to have the IRBs stop dissipating all of
their energies in doing the pointless things, some of which I specified
Give them the opportunity to spend some
time thinking about real ethical issues. We're finding as a result
of some of this that people are becoming less and less willing to serve
I quoted Norman Fost earlier. At the
same meeting that he presented his informal survey of the results of
review of periodic reapprovals, he said that he actually had two
members of his IRB stand up and walk out in the middle of an IRB
meeting saying, "This is not why we joined the IRB, doing what
we're spending all of our time doing. This is not the thing that
attracted me to serve on IRBs."
I've made that statement in public
before and somebody said, "That's self-serving. You're
trying to make life easier for your friends, colleagues."
It's not self-serving. It's not
at all self-serving because the only thing, the only thing that allows
the IRB to do what good it can do is to have the dedicated, learned
people find it's worth their while to get together from time to
time and to discuss the ethics and to some extent regulatory
I think if you could find a way to
restore the status of the IRB and to restore the attractiveness of
service on the IRB, that that would be a great contribution. I
don't want to seem totally innocent of the realities of everyday
Another thing that's making it hard
to get people to serve on any committee is the budget crunch. When you
tell the members of our clinical departments that you've got a
quota, you've got to bring in this amount of money and if you
don't, we're going to cut your salary, well, they're not
bringing in any money serving on the IRB or the Admissions Committee.
So there's other things going on, but
I think it's within your capacity to make a statement about what is
within the control of the federal human subjects protection community,
I'll call it.
DR. FOSTER: That's very helpful.
Everything you've said has been really, really helpful, and I think
Leon was driving to the issue where we had thought — he and I talked a
little bit about it this morning — well, maybe there's not so much
importance about the research in children because of the fact that
there's so much already written about it. It's hard to know
whether there's anything really new about it.
But the idea about restoring the
importance, I mean, to give time to do what has made it relatively
safe, which is at jeopardy because of all of these what you presume is
largely mindless activities of the bureaucracy, that might be something
that we could do something on.
And I'm not myself very enthusiastic about pursuing protection
of adults or children anymore. I Mean it has just been going on
for so long. You know, you've got the Jesse Gelsinger case,
you know, mistakes like that. There are always, but the denominator
is very large.
So I think the most important thing that
you have said is the last thing. I don't know whether Leon or the
rest of the people agree with it, but I would think that would be —
and it wouldn't take a whole lot of work to do that, but it would
— if it came from a group like this, which is not filled with
bioethicists to argue the point that you have made, it might have more
impact than if a person like yourself, who has been such a stalwart, to
I just want to thank you for bringing
that up, whether we do it or not. I think that's a very important
point to bring up.
DR. LEVINE: Well, thank you. You know,
the Gausier case is a very good case to consider for a minute. After
this unfortunate young man died, everyone said, "Well, if there
had been an adequate IRB review, this would not have happened."
This young man died because there was an
investigator who told lies to the IRB and who told lies to the FDA.
This guy did a double jump in a Phase 1 gene transfer evaluation even
though there were adverse events at the dose level from which he did
his double jump.
This gives the whole human subjects
protection field a black eye because the journalists are saying, well,
the IRB could have done it, could have stopped this if it was adequate.
I can go on and on. May I tell one more
story about —
CHAIRMAN PELLEGRINO: Yes.
DR. LEVINE: — a problem? How many of
you know about the UCLA schizophrenia placebo study? How many of you
have heard of it? Astonishing.
When the litigation was filed about two
— it was a class action suit with two named plaintiffs who were
damaged by being in a placebo or receiving placebo instead of an
antipsychotic medication. This was banner headlines in almost every
American paper. This was high level coverage on "60
I've talked about this in front of
groups of IRB people. They all have heard of it. Then I say, "How
many of you know what the final outcome of this dispute was?"
The final outcome, they asked for $70
million. The final outcome is that UCLA settled with the plaintiffs
for $199,000. Why? Because their lawyers advised them that it would
cost them $200,000 to win the case. Okay?
All right. We don't need all of this
fuss. We'll give you 199 if you go away.
What does this translate to? This
translates to not one nickel for the plaintiffs. The lawyers got
$199,000 and estimated that their actual out-of-pocket loss was $2
The meaning of this is that these lawyers
knew they didn't stand a chance if they argued this in front of a
jury, but the point I'm trying to make is that when somebody makes
an allegation about our human subjects protection system you get
"60 Minutes," you get headlines, and when the case is
resolved, you can't find it in the classified ads because it's
note even there.
And that's part of our problem.
CHAIRMAN PELLEGRINO: Thank you very
Well, I think we're right on time.
So we'll regather now at 3:45.
(Whereupon, the foregoing matter went off the record at 3:30 p.m. and
went back on the record at 3:50 p.m.)
SESSION 4: CHILDREN AND CLINICAL RESEARCH
CHAIRMAN PELLEGRINO: It's time to
reconvene. We're actually five minutes late, but we'll get
back on schedule.
Our next speaker is Dr. John Lantos, who
is Professor of Pediatrics and Associate Director of the Medical Center
for Clinical Medical Bioethics at the University of Chicago.
Dr. Lantos is going to address us on the
question of children and clinical research, continuing something of the
discussion we've had a little bit earlier.
DR. LANTOS: Thank you.
So I'm a general pediatrician and a former associate chair
of the IRB at University of Chicago, and that discussion at the
end of Bob Levine's talk was pretty interesting because I quit
being chair of the IRB after they imposed the regulation on us that
the IRB chair had to read at a convened meeting all of the amendments
that had been submitted. And if any of you have ever been on the
IRBs, the amendments tend to be wording changes in the informed
consent form. There would be 200 or 300 every meeting, and at the
end of every meeting the chair would go through them reading, "This
was submitted. Here was the old language. Here is the new language,"
yelling, "aye," approved. Here was this, and the rest
of us would go get coffee or cookies, and this was read into the
tape recorder so that when we were audited it was clear that this
So the concerns about IRBs and their
current function in relation to their mission, I think, are important
ones to address.
In my own work, I look at innovative
therapies in pediatrics, things like neonatal intensive care, growth
hormone, cancer chemotherapy, bone marrow transplants and that sort of
stuff, and really focus my scholarly work on that gray zone sort of
just beyond what's usually considered research and sometimes called
innovative therapy in some of the dilemmas that arise in that area.
So I'm going to talk today about
where I think we are in the regulation of pediatric research, where I
think we should go, and come out at a little different place than Bob
Levine came to. I think there are some important things to be done
that this Council might be able to speak to, and I'll tell you
where I'm going so that you can then listen wondering how I might
ever eventually get there.
I think today — and this is partly in answer to Leon's
question at the end — I think today we have a marvelous set
of moral guidelines for research in children and people like Bob
Levine helped develop them, and a lot of the people who he cited
helped put them together. And they're marvelous, in part, because
they're half written and, therefore, require interpretation
in order to be operationalized.
And unfortunately, there are only about a
couple dozen people in the country who understand them and are familiar
with them, and they meet regularly and write articles about them and
regularly disagree, quite often passionately, and they'll have
discussions about 45 CFR 46 and Subpart D and what the latest 407
Committee did, and everybody else will sit there shaking their head
going, "What in the hell are they talking about?"
DR. LANTOS: But they're sort of
important, subtle distinctions about what sort of research is
permissible, and as a result, there's a set of robust but arcane
understandings by this small group of highly trained professionals
which incorporate ethics, but don't necessarily apply it in their
In a way it's a little misleading to
have someone like Bob Levine come here speaking as if he's a
typical IRB chair since most IRB chairs did not participate in this
process, are not steeped in the history of the ethics, where it came
Our chair at Chicago is an
anesthesiologist who proudly claims to know nothing about ethics and
works closely mostly with the compliance officer in making sure that
the institution is protected from risk management.
So what we have is a good set of rules
and an abysmal system for operationalizing the rules, and that's,
in my opinion, where the action is and what this Council should think
about ways to address. So let me explain how I think we got there and
then offer some specific suggestions about how we might address the
So the modern debate about the ethics of
children's participation in biomedical research began as a
theological debate. Paul Ramsey and Richard McCormick, both of whom
were rooted in specific religious traditions, but neither of whom was
arguing on the basis of their particular theology, framed the issue,
and this was in the late '60s, early '70s, as one of finding
the balance between the obligations of adults towards children and the
obligations of children to their community.
In a sense, their differences about where
we should come down on this reflected their different views, in my
opinion, of the meaning of children's innocence. In Ramsey's
view, we should treat the child as radically innocent and pure and,
therefore, as someone with different obligations to the community than
those demanded of adults with full fledged community membership. To be
a member of the adult community is to be autonomous, and by implication
both selfish and also capable of sacrifice or altruism for the
And this was important because for
Ramsey, participation in research was seen as an altruistic sacrifice.
Innocent children were seen as in special need of special protection
from the moral taint of selfishness that the adults suffered from.
So the moral dilemma of selfishness
versus altruism was something an adult could struggle with, but a child
McCormick's contrasting view was that
the child was already a full fledged member of the moral community even
though he or she was unable to exercise some of the prerogatives of
that membership, and as a full fledged member, he or she deserved the
same protection as an adult, but not more protections.
And more importantly, he or she had
obligations to that community. In particular, the child had an
obligation as would an adult to participate in relatively low risk
research projects that could benefit others.
So McCormick's view was different in
that it shifted the notion of obligation and made it reciprocal from
day one. Note that neither theologian based their arguments on any
notion that there was benefit to children or to the child who was
participating in a research protocol, although both talked about the
possible benefits to the community of children, but research was seen
by both as an endeavor in which the risks to the subject inevitably
outweighed the benefits, therefore as a selfless or self-sacrificing or
So Ramsey's view led to the
conclusion that it was always wrong to conduct research with children
as subjects, although sometimes we should do so anyway with trepidation
but without, as it were, a clear conscience.
McCormick's view seemed to be that it
was sometimes right because children, like the rest of us, have moral
obligations to the community, and it's sometimes right for each of
us to make sacrifices for the community.
Now, a number of things have happened in the world of research
and research ethics since this Ramsey-McCormick debate that in my
opinion shift in significant ways our understanding of the proper
response to this dilemma of research involving children, but their
central insight remains powerful, but the fundamental issue is one
of the relationship between children in the community and the question
should be what, if anything, do we owe our children and what, if
anything, do they owe themselves and us, and what can we do theologically
or ethically or legally or politically or economically in order
to make sure that these obligations are duly and fairly discharged?
How do we best take care of them so that they will some day grow
up and be able to take care of themselves and, as these things often
go, take care of us some day as well?
This basic argument or responses to this
question in modifications to the Ramsey-McCormick framework over the
years have been framed in three different ways: one that I will call
utilitarian, one that we might call epidemiologic, and one that is more
bioethical. And I'm going to talk a little bit about these three
revisionist framings that present the dilemma in terms that are
somehow, I think, more conducive to, say, a secular society's
preference for scientific or utilitarian language or other
non-theological conceptual framings.
The utilitarian framing of the issue
looks at the net welfare for children, and we talked a little bit about
that in Bob's session. We say that the community of children
overall would be worse off if no children participated in research, and
then by a sort of implicit calculation that is the central and
centrally problematic feature of all utilitarian reasoning, we argue
that since each child is a member of the community of children, each
might be harmed by the use of inadequately studied medical
interventions, and that each child would or could be incrementally
worse off if no research gets done.
So the direct and immediate harms of
participation in research are weighed sort of metaphysically against
the potential benefits that might accrue if the results of that
research benefit each particular child. We carry out the mediphysical
calculations in our head and end up with the result that some research
must be permissible as long as it doesn't involve too much risk or
as long as the benefits to the individual research subject outweigh
And then we go to great pains to try to
precisely quantify the risks even though we know that the very nature
of research dictates that the most important risks may be unanticipated
and, therefore, unquantifiable.
Sincere attempts to balance risks and
benefits in order to minimize the net risk and to stipulate some
threshold of permissibility seems to me to be the correct solution to
this problem, and this is the line of reasoning that generated the
federal regulations that talk about minimal risk and minor increase
over minimal risk and some increase over the minor increase over
minimal risk that leads to the 407 committee review and incorporate, in
my opinion, deep moral insight and are full of wisdom. I even like the
vague fussiness of terms like "prospect of direct benefit" or
"minor increase over minimal risk," and the wisdom here seems
in part to be the wisdom of moderate ambiguity.
I was reminded of this at our Seder this
year where we were talking about what constitutes a cup of wine as a
moral obligation to drink four cups of wine, and at least according to
one source the rabbis gave a precise answer to that. A cup of wine has
to be at least the size of two olives.
DR. LANTOS: And that sort of answer that
is a non-answer but that gives, you know, an inclination. Some
guidance, I think, is what we're looking for.
Another modification of the
Ramsey-McCormick framing of the issues and the one that I call
epidemiologic has been through discussion of a concept that I called in
a paper I wrote, and it's in the notebook, "The Inclusion
Benefit." And the conception of inclusion benefit is both an
empirical one and a theoretical one.
Empirically, many people have observed
that many subjects in clinical trials who are in the placebo group do
better than patients who are not in the trial at all and, therefore, it
seems should be receiving the same treatment as those subjects in the
placebo group, and yet they have better outcomes.
Why do they have a better outcome? A
number of explanations have been proposed. All remain unproven,
speculative, highly theoretical. One explanation is that placebos
actually work. Another is that the accoutrements of study design,
monitoring, standardization of care, attentiveness to side effects and
that sort of thing are what lead to the improved outcome.
Some believe that it's all selection by us or artifact that
subjects who were recruited into studies are in some fundamental
way different even though they're not supposed to be from patients
who are not.
And all of these explanations and a bunch
of others seem plausible, some more plausible than others, but
epidemiologically it doesn't really matter because epidemiology
doesn't necessarily seek explanations, just associations, and there
seems to clearly be an association between inclusion in a clinical
trial and better outcomes.
Now, the underlying question raised by this concept, the ethical
question, the concept of inclusion benefit, is one of the true nature
of the risk of participation in clinical trials. If for whatever
reason study subjects who receive standard therapy actually do better
than patients who are not in the study, then the whole basis for
the concerns of the Ramsey-McCormick debate and the whole justification
for the regulatory apparatus that those concerns spawned based as
it is on the idea that research is riskier than therapy becomes
irrelevant, invalid, and misguided.
Instead, research subjects are in a safer condition than patients
receiving therapy. They don't have to be altruistic. Instead
they are rationally self-interested. They don't participate
out of moral obligations of the community. They don't need
to be protected. Instead, they should be required to give informed
consent not to participate in a clinical trial, and children's
whose best interest must be protected in ways that adults don't,
might be mandated to be enrolled in clinical trials even against
their parents' preferences.
Parents who refuse may be thought of as
neglectful. I push this to an extreme, but maybe not an outlandish one
because I believe that in general, and across the board, subjects in
clinical trials are today safer than the average patient getting
treatment either in the hospital or in the out-patient setting.
And if that's true, then the way
we're going about regulation is at least misguided, if not worse.
There's a third revision to the
Ramsey-McCormick paradigm for thinking about research risk, one that
might be called the moral dictates of equipoise argument, and it goes
like this. If a doctor or the medical community is genuinely uncertain
about which of two treatments is best, then the most rational and
efficient way to insure that each patient gets the best treatment is to
randomize patients, collect outcomes, analyze the data, and alter
treatment choices only after one treatment has been proved superior to
By this argument, randomizing as soon as
possible and with each and every patient is the best way to do
what's in the patient's best interest, and this is an approach
that is essentially used in pediatric oncology today, where virtually
all patients are treated on protocols because doctors believe and
parents come to believe that the protocols are, in fact, the best way
to make sure each patient gets the best treatment in a situation where
doctors are genuinely uncertain whether Treatment A or Treatment B is
better. Randomizing them maximizes the chance for a good outcome, and
by this approach, the Ramsey-McCormick sorts of conflicts disappear as
Interestingly, the concepts of inclusion
benefit and the argument from equipoise, powerful as they are, have not
changed the prevailing regulatory paradigm about research risks at
all. If anything, the paradigm seems to be moving in the opposite
direction, imposing more and more protections to still regulate
research as if participation added risks to subjects rather than
This seems irrational, but perhaps it
isn't. Perhaps instead it reflects a deeper fear of research than
the one we generally analyze and regulate, that is, the fear of direct
physical or psychological harm to study subjects. And what might that
deeper fear be?
I think it's a fear that has come up in a lot of the deliberations
of this Council, that somehow the whole medical research enterprise
suffers from a sort of hubris that we are up to no good, that we
are going to get ourselves into trouble, that mad scientists are
going to hijack not just our tax dollars, but our cherished notions
of what it means to be human. It's a fear that we're trying
to steal fire from the gods, that we're upsetting the order
of nature and that we will be punished for it, fears that perhaps
medicine is not working to enhance human dignity but to undermine
And by this view the only way that we can
avoid punishment is by recognition of an anticipatory expiation of our
sinfulness by identifying it in our research enterprise and ruling it
out. We don't use hubris language generally, but we are possessed
with risk in ways that go beyond quantitative analysis of what these
risks might be.
Even if you don't think research is beneficial, the operationalization
of these concepts of minimal risk and minor increase above minimal
risk has a quantitative absurdity to it that was highlighted in
a recent paper in JAMA where they tried to quantify the risks of
everyday life which is the standard against which participation
in research ought to be measured, and they took all of the data
on known risks of being in research projects based on reported adverse
events and compared them to things like riding a bike or riding
in a car or playing on a school football team and found that our
tolerance for risk in research is probably an order of magnitude
lower than our tolerance for the actual risks of everyday life.
And part of what we're doing it seems, is, if this sort of
fear of hubris and seeking of absolution argument makes any sense,
is we're arbitrarily designating one domain of medical innovation,
the stuff we call research, which takes place in formal research
protocols, as the only place where this sinful hubris rears its
ugly head. And then we treat those who engage in research as if
they were doing something morally much dicier than what those doctors
who are doing routine clinical care are doing, and they need to
be carefully supervised. They are not safe, and by implication
everybody else sort of is.
Now, even a cursory look at what goes on
in pediatric medical centers today shows what a precious and inadequate
view this is. Most of what we do in tertiary care or pediatrics today
is radically and thoroughly nonvalidated. Most drugs used in
children's hospitals today are used off label. They've never
been studied in children and are not approved by the FDA for use.
We don't know, for example, such
basic things as the proper dose of oxygen for a premature baby or the
best blood pressure at which to maintain those babies, that is, what
use of dopamine or dobutamine or other pressors are the best way to
treat pain for children with complex chronic conditions or
psychological problems. We don't know the best medications, though
we use scores of them, or the drug-drug interactions that might arise.
Nevertheless, we use such interventions
willy-nilly, treating problems in ways that may make children better or
may make them worse, and we do so with impunity as long as we don't
have the hubris to think that we might better care for children if we
studied the effects of these interventions in order to use them more
Better research could answer many of the questions, but oddly,
we place daunting regulatory barriers in the way of those who would
study those matters, but none in the way of those who would use
the interventions without study. Or as one doctor put it, "I
need IRB permission to give a nonvalidated drug to half my patients,
but not to give it to all of my patients."
As long as one doesn't have any
desire to learn, that is, to create generalizable knowledge, one is
free to do whatever one wishes.
The implicit moral question seems to be
that harms that result from our ignorance are more forgivable than
harms that result from our attempts to lift the veil of ignorance.
Ignorance, it seems, has a pristine, naturalness to it. Attempts to
gain knowledge have a corrupt ambitiousness to them.
I wish I could phrase these matters in
terms less hoary or spiritual, but it seems that the phenomena in
question, the actions and the descriptions of those actions that come
down to us, aren't well explainable in other terms.
Now, my framing of the argument in these terms suggests something perhaps
about my own view of where we should go from here. My colleague
in Chicago, Lainie Ross, recently wrote a book about ethical issues
in pediatric research and her subtitle to the book was "Access
The subtitle implies that these are
opposing choices, that if we enhance children's access to research,
we somehow diminish their protection and place them at risk. I
fundamentally disagree with that framing. I think the best way to
protect children from the risks of uncontrolled medical innovation is
to make pediatric clinical research easier to do.
That doesn't mean it should be
unregulated. It means it should be better regulated. How might that
be achieved? How might we nudge the system that we have now towards
more generous, less inhibiting approach to research regulation? I
think we are today at a very interesting point in the public policy
regarding research regulation in children. As we discussed in
Bob's session, we understand the problem. We have some good and
sophisticated federal regulations. There are quite thoughtful debates
about how best to implement these regulations, what minor increase
above minimal risk or something might actually mean. There's
little disagreement today, I think, about the underlying paradigm.
Nobody really wants to blow the whole thing up and start over, but what
we need today is a way to best operationalize these standards of risk
and the balance between access and protection, and the efficient
implementation of the procedural paradigms that will help generalize
the knowledge that now in my opinion is held by this small coterie of
experts in the field.
What we need, in short, in my opinion, is
to develop a more formal and robust casuistry of research ethics. We
need case based studies that open up to us the choices about how the
principles should be applied in each specific protocol, and we need to
find a way to capture or a better way to capture and to
institutionalize the wisdom of these smart people who have thought a
lot about this in ways that, as Richard Epstein might put it, increase
net social utility.
This can only be achieved through a
formal, transparent and trustworthy system of case review, commentary
and adjudication, something that does not exist in the current system
of research regulation.
The balance to be struck now then in my
opinion is quite different from that imagined by Ramsey and McCormick.
It's not about sinning bravely. It's not about deciding when
children should be exposed to risks for the benefit of others.
We've moved beyond that.
Instead what we seem to be debating today
is the proper locus of regulation, whether it should be decentralized
local regulation as embodied in the IRB system where each IRB sort of
has its own autonomy, or whether there should be a more centralized
and, therefore, consistent but distant approach that is some sort of
appeals process for IRB decisions, reporting of the rationale behind
decisions, and opportunity for public discussion.
The former, the local IRB approach, seems
more like what bioethicists in the '60s and '70s had in mind,
and their idea was that there would actually be sort of moral
deliberation taking place at the IRB level about these protocols. As
we heard in the earlier session, we've moved away from that.
The latter approach, the one that I'm advocating, seems more
legal than bioethical, and generally I think anything that's
more legalized is a bad idea, but unfortunately, I think what we've
ended up with today is the worst of both worlds, that is, we have
nonaccountable centralized control, that is, the federal Office
of Human Research Protections (OHRP) that as best I can tell answers
to nobody, but that oversees the local IRBs that operate with inconsistence
Many studies show wide variation in the way local IRBs actually
apply these regulations with things like the question that came
up. What counts as a minor increase over minimal risk? And people
have done studies where they have sent IRBs various protocols and
shown that they're all over the map in whether a particular
protocol would pass or not, based on their understanding of the
And these are published in JAMA or other
peer reviewed journals, and everybody goes, "Huh, yeah, it's
random." Not much you can do about.
Many investigators, I think, correctly view IRB chairs as despots with
absolute power and minimal accountability, and even if they are
benevolent despots, there's no way to know it.
IRB chairs tend to view OHRP the same
way. That is, they see their task not as applying their own moral
insights, but as protecting the institutions from random audits and the
fear of draconian punishments for relatively minor transgressions, that
is, not reading out every amendment to a protocol at a fully convened
meeting leads to the shutdown of entire institutions and all of their
And so what we've come to is a
climate of caution, self-censorship and the domination of institutional
risk management approaches over careful moral reflection. It's a
counterintuitive result because the rules that led to this system were
meant to preserve the local control of IRBs to make them exquisitely
sensitive to the local conditions in the way that a federal or
centralized IRB might not.
But what they have led to is this
inconsistent application of highly technical federal regulation in ways
that are not reviewed, not disclosed, and therefore, not available for
The reasons why we have ended up with
this are complex, but let me just briefly suggest two, and then I will
try and finish up and hopefully have some discussion.
One of the reasons is that the mandate
for IRB review is an unfunded mandate. So IRBs are staffed by
volunteers from academic institutions and that may have made sense when
the process was more informal and the group could meet, but as it works
today, with every protocol having to be reviewed every year, with every
amendment having to be reviewed, with every adverse event having to be
reviewed, we have an IRB that used to meet once a month, but the
meetings were running ten hours. So how they've split up into
three separate IRBs, and even with that they've gotten the meetings
down to about four hours. There's about 15 faculty members on each
of the three IRBs putting in four hours a month of committee time, plus
all the review time with no compensation.
And I think you get what you pay for. In
this case it's amateurish, idiosyncratic, and often bizarre reviews
or the jobbing out of the real work of the committee to a paid staffer
who is usually basically a compliance officer.
So that's one, the unfunded mandate.
If this system is going to work, there has to be some way to put some
funding in it to make it work better.
The second reason I think they don't work is sort of more
interesting in some ways from a legal perspective, and that has
to do with the reason why IRBs preserve privacy and confidentiality.
It's hard to come up with a good explanation for this that's
framed in terms of the protection of research subjects, and the
usual explanation is that it is necessary to protect the careers
and the intellectual property of the investigators. There's
no other reason I can think of to make these deliberations confidential,
and that's possibly an important concern, but to the extent
that research in children is to become a more publicly accountable
enterprise, there must be ways to protect investigators' intellectual
property that are consistent with a more open, transparent, and
publicly accountable review process.
So in place of the current system what I
would propose is a system that was more formal in its adjudication
methods, but also more transparent to research institutions, to
investigators, to parents in the case of pediatric research, and to the
public. In short, we need something like an appeals court system, a
system called pediatric research courts, and the goal of such a system
would be to help researchers apply agreed upon and quite satisfactory
standards, and it would do this by hearing cases, publishing rulings,
establishing precedents, generalizing interpretations in a way that was
truly public, meaningfully accountable, and transparent.
Such a system would have to be
collectively subsidized in a transparent way, too, because it would
certainly cost money, but I think it would be a tangible expression of
our commitment to protecting children from both the risks of research
and the risks of unstudied innovation.
And in that sense, it would return full circle to what I see as
the central question raised by Ramsey and McCormick: What do we
owe our children? And it would answer it by saying we owe them
a functional system for the oversight of pediatric research that
maximizes the opportunities for children to receive the latest treatments,
the best treatments, and the safest treatments, even if and especially
when these treatments are given as part of a carefully designed,
carefully monitored, and adequately reviewed research protocol.
In my opinion, we owe our children this
much at least.
CHAIRMAN PELLEGRINO: Thank you very
Dr. Lantos' paper is open for
discussion. Dr. Meilaender.
DR. MEILAENDER: Thanks very much. That
was nice in a lot of ways.
But I have two questions that probably may sound to you as if
they are willing to reckon with blowing up the whole system, which
you clearly don't want to do, but they have to do with the inclusion
benefit, your discussion of that, and with the equipoise issue.
You said about what appears to be the case with respect to the inclusion
benefit that it really makes the issue in that earlier debate irrelevant.
I don't actually think you believe that because of some things
you said you wrote in the pieces that we had. But nevertheless
you did say it, and I mean, I understand why you're saying it.
But doesn't saying that depend fundamentally on believing that the
only important moral question is the one that has to do with harms
rather than wrongs? At least in some ways of thinking morally,
it is possible to wrong someone without harming them.
And the structure of your argument with
respect to the inclusion benefit is a structure of argument that deals
entirely with the issue of harm. As it turns out, they're not
really harmed. So they can't be wronged in anyway, but it might be
that using subjects who cannot consent in any ordinary way wrongs them
And that was, of course, part of that
earlier debate. I don't think you actually think that's
irrelevant because you recognize in your written work that there's
a difference between seeking generalizable knowledge and giving
particular care to patients, and if I use my patient for generalizable
knowledge, I might be wronging them even if in another sense they
So I'd like you to think about the
structure of that argument and whether the whole basis of your argument
on the basis of the inclusion benefit already presupposes a certain
approach to the moral life that may or may not be acceptable.
That's the one.
The other with respect to the equipoise
issue, I sometimes wonder, you know, whether any two possible treatment
modalities are ever in equipoise for a particular patient or how one
knows that, but in particular, you mention that most of the care in
pediatric oncology is done through randomized trials of one sort or
I remember reading an article a few years
back about breast cancer research with adult women in which in several
cases the researchers were delayed by years having trouble doing the
research because they couldn't find women willing to be randomized
in it, but the article mentioned that this wasn't a problem in
oncology research with respect to children. They had plenty of
And it struck me that there's a
reason for that. The risks or whether the risks are not even — I
don't know what the right way to describe them is, but the
procedures that we're unwilling to run for ourselves we seem quite
willing to let children run, and if you think about that, it raises
once again the question about whether the issues at stake in that
earlier debate don't remain real issues in a way. I'm not
saying necessarily they must be resolved in one way, but I do think
that they haven't become irrelevant.
So maybe you could comment on both of
DR. LANTOS: Thanks. Those are great
Harm versus wrong, I mean, to a certain
extent my discussion today focused on research that has a prospect of
direct benefit, and I think the farther you get away from prospect of
direct benefit the easier it is to imagine a wrong that might not
necessarily have a harm associated with it.
I'm trying to imagine a protocol
research project. Maybe you can help me if you have one in mind where
there was a prospect of direct benefit. There was no harm, but a child
would be wronged in some way by participating.
DR. MEILAENDER: Well, if you were
Ramsey, unconsenting touching was a wrong whether it resulted in any
harm or not.
DR. LANTOS: Even Ramsey wouldn't
have considered clinical care a wrong. I mean, every day I touch
children who don't consent when I do my physical examination on
them and they scream and squirm and try to get away. I'm not sure
how my gathering data through my physical exam that I then try to
generalize would sort of kick me up a level of wrongness in
DR. MEILAENDER: Well, he thought their
parents had reason to consent to that because it was part of parental
nurture of their well-being. Now, you may be able to be on your way to
an argument that placing my children into a clinical trial, at least if
they're of an age where I can explain to them that they're
helping others, would be similar parental nurture, but that's what
made the touching okay there. It wasn't anything to do with the
consent of the child.
DR. LANTOS: Well, in that case, if the
concept of inclusion benefit has some validity and the parent gave
consent for a child to be in a pediatric oncology protocol because they
correctly believed that that was the best thing for their child and, in
addition, we would gain generalizable knowledge, I don't see, if
that's what Ramsey said, then I would disagree that that's some
Let me say one other thing though about
inclusion benefit that's important and may explain a little better
why I don't think the notion of inclusion benefit means we should
blow the current system up.
I think part of the reason why there is
an inclusion benefit, part of the reason why it's safer to be in
research protocols is because research protocols are highly regulated
so that a world in which we said, "Oh, it's better to be in
protocols than not. So let's get rid of IRB review."
All of this stuff about making sure
protocols are safe is clearly nonsense. Everybody who goes into a
randomized controlled trial would not achieve that end. Putting people
into randomized controlled trials that had been scrutinized, have been
reviewed, I think, would.
As far as the argument for equipoise,
I'm not sure I'd draw the same conclusion. I mean, I think
about people willing to subject their children to risks or wrongs or
harms that they're not willing to subject themselves to. I mean, I
think the breast cancer example is an interesting one because I think
if we're talking about the same study, it was randomizing to a
lumpectomy or mastectomy, and I think what was driving that was
people's assessment of the cosmetic results and saying, "I
don't care if these two therapies from sort of a five-year survival
perspective are in equipoise. From the perspective of how I'm
going to look afterwards, they're not, and that's why I'm
not willing to be randomized."
So in that sense, the researcher's
failure to take that into account as part of what should go into their
equipoise calculation just made it a badly designed study, in my view.
I think there are clinical situations
where it's probably impossible to get a group of people who are in
equipoise. It is an incredibly fragile and somewhat ambiguous concept,
but I think the fact that parents are willing to sign their kids up for
cancer chemotherapy protocols doesn't necessarily mean they're
willing to allow their children to undergo risks that they wouldn't
be allowed to undergo themselves. It may mean that they're making
better decisions for their children than they make for themselves, as
parents often do, I think.
CHAIRMAN PELLEGRINO: Dr. Kass? Oh,
I'm sorry. Paul.
DR. McHUGH: This may be a question
that's only the product of a long day and since I've had a lot
of experiences that you've touched upon and have been touched upon
before on IRBs and relationships to institutions and external forces
and the like, I reverberate with all of the things you're saying.
For example, not to go too long on this matter, but I was on an
IRB about 15 years ago for a number of years, and it was a wonderful
experience because it introduced me to all of the different investigators
(and investigations) that were going on in the institution from
across all kinds of disciplines, and it was terrific.
Not only that. I appreciate my
institution better. I also appreciate my fellow investigators and my
fellow doctors in the sense of the imagination that they were showing
and things of that sort, and things seemed to go quite well.
Now, it's very hard to get anyone to
go on an IRB because not only is it not of this sort anymore, very,
very long and arduous process in the sense of doing a bureaucracy's
job is very unpleasant for people who see and appreciate that they have
much better things to do for the benefit of patients, given that most
of us do still have a vocational commitment to helping patients.
So, as well, from what we said this
morning when we see this huge discrepancy between organs and the
availability of organs and the demand for organs, it's clear to me
that the method that we're using, even if toned up, is not going to
solve this problem. This seems to me this is happening with the same
We've just got ourselves stuck into a
process which is just going to get worse and worse and worse as the
bureaucrats imagine further and further things that could go wrong. No
industry could survive with this method if it hoped to be productive
The car industry couldn't work this
way, given that, you know, it makes mistakes, too, but ultimately makes
progress and makes progress sometimes through the mistakes.
Are we getting to the point of where we
should be thinking of another approach entirely? As I say, this might
be off the wall at the end, but you know, in medicine now, we are very
accustomed, all of us who were in medicine are accustomed to the Joint
Commission's demands on us to look at our practice and particularly
look at the ethics of our practice, the quality of our practice, and
where it goes wrong.
It does it with this root cause analysis that is, by the way,
extracted from the automobile industry, incent events with what
you were saying, case studies in which when something does go wrong
the case is studied from top to bottom, not just from who made the
mistake here, but who gave this person authority to be in that position,
what were the resources that were needed to do that properly, what
wasn't made, and the like. And ultimately those get circulated
around the country and our medical practice, just like our industrial
practices, get better.
Has the time come for us, appreciating that being part of research is
very helpful — by the way, there are plenty of examples where
you can show that the placebo class really got better. The whole
study of insulin shock for the treatment of schizophrenia was brought
to an end when it was demonstrated that the placebo people did just
as well as the treated people and both of them were doing well because
they were backward schizophrenic patients that were now brought
forward and people were now worried about their blood sugars for
several hours a day, and when you did that, they improved.
And now we have this ridiculous business
about where Paxil is producing suicidality in a small proportion of
children, but no one knows what they mean by suicidality, and we have a
black box label on this. The pharmacologists are not being drawn into.
I mean, that's a real signal, by the
way. It really is happening out there with certain forms of the SSRIs,
but you know, we're not doing what we ought to do and we would if
we were running an automobile industry, that is, saying, "Okay.
What's happening here?"
So the long and short of this tirade —
I'm sorry about it at one level, and it's probably not very
helpful — is to ask if we are an Ethics Council and if we are saying
can we begin to blow a whistle on a process that is inherently going to
run in a particular way and run us out of the business of doing better
in research for the benefit of our children and for the benefit of
DR. LANTOS: One quick comment, just to
be clear, on the placebo versus control. I mean, many studies show
placebo do as well as the control group. What I was talking about is
the placebo group doing better than the people who weren't in the
study at all. So that's slightly different.
I mean, my solution to the overburdened
bureaucratic thing would be to say 90 percent at least of what IRBs do
could be done just as well by a single compliance officer. Ninety
percent of it could be done by the IRB administrator, and I'll bet
if you did a randomized controlled trial you'd find that the
outcomes were exactly the same.
It's basically making sure that the
protocol meets fairly straightforward regulation. So one interesting
question is why, given that, we have this system where like really
expensive people with no expertise instead gather around and listen to
the compliance officer tell them what they have to do.
That seems to be sort of a remnant of
sort of an idea of what we wanted to imagine the role of a research
ethics committee ought to be with regard to some of these more
interesting questions about harm versus risk and the moral ambiguity of
medical progress and stuff like that.
So if there was a way to sort of flag the
ones that need that kind of review, you could imagine using the
resources of an IRB to focus on those, and those would be the ones that
I think might end up going into my appeals process generating
essentially case law that could then sort of capture the wisdom of
those deliberations in a way that isn't being captured now.
What's happening now is it's both
a waste of time while the committees are meeting and then it's a
waste of any outcome because it's kept secret and nobody gets to
learn from the deliberation.
So I mean, in that sense I think blowing
up the system might work, but I guess I would see that more as a
tweaking of the operationalization of —
DR. McHUGH: And the bureaucrats would
find some other way to consume your time even more because it isn't
the work of obsessional bureaucrats to imagine troubles. I mean,
that's what they have, and so they could imagine all kinds of
stuff, and if good cases are not studied, studied thoroughly about what
really went wrong so that you can appreciate how unique those were and
how everybody once read about them would remind themselves of how they
should practice and do research in the future, we could accomplish just
as much, but it requires a trusting interaction that perhaps is
impossible for these people to use if this method is persistent.
You know, at Hopkins we had a terrible
disaster, but once it was really studied, where the mistake happened
and what was the error and how the literature should have been better
studied and all came to light for all of us. It was a distressing set
of events, but it wasn't protected by the IRB. It wasn't going
to be protected by making the IRB do more things which we now do.
Many people still don't know what
went wrong at Hopkins in the best sense. So at one level maybe
we're — I'm repeating myself, but just this system might not
be the right one for an industry that is so beneficial and as much
beneficial as engineering and other kinds of things that know how to do
CHAIRMAN PELLEGRINO: Dr. Kass and Dr.
DR. KASS: There's several things
that I could raise with you, John, but let me pick up those
quasi-theological remarks suggesting that you might have detected
certain things in other works of the Council as possibly explaining why
it is that we are so nervous about experimental subjects through
discussion of the fear of hubris and the expiation of that sin.
Hey, I by the way don't think that
has in any form been operative in here, but that's another matter.
I don't think that people who worry about the use of human subjects
in research are primarily trying to use the research scientists as the
focus of their anxiety about where science might be taking us. Maybe
some people do and think about the mad scientist.
I think the major thing really comes down
to the human use of human beings on which you yourself are, in fact,
toward the end of the article, as I read the passage — I think
it's the thing Gil is alluding to — research is considered
hazardous because the physicians who conduct research are using the
patients as a means to an end. Their goal is no longer solely the
well-being of the patients. They are also, perhaps primarily committed
to the creation of generalizable knowledge.
And let's grant the humanitarian
ambitions. Let's not dwell too long on the fact that in addition
to the humanitarian ultimate goals there are careers to be made and
self-advancement which depends upon this kind of research.
I think that what we're dealing with
here is not so much the nervousness about the ends, but real questions
about the means and about quite apart from the hazards what it means to
make especially a child an object of investigation for someone
It's very different, as Gil points out, when you bring your
child sick to the doctor. There's a laying on of hands with
a specific goal in mind. The other is, for better or for worse,
however lovingly you make the situation, lovingly you treat the
child and however attractive the situation is, the child is a research
Now, clinical trials in oncology where it
is not clear which treatment is better, that's different. But what
about the things that Bob Levine says are somehow ruled out by the old
principles, studies in pathology, pathophysiology, studies in the
neonates where you aren't to sort of look at the parent and say,
"I don't know really which treatment here is best, but in
order for us to get to the point where we can even begin to imagine
certain treatments for this, we've got to subject your child for no
benefit to him or her so that we can gain this knowledge even, by the
way, if no harm comes from it.
Even if no harm comes from it, I as the
father of a child would be reluctant, however much I understand the
goodness of knowledge, I would be somehow reluctant to make my child an
experimental subject, period.
And I think that in your final analysis
of the things that we owe our children, that wisdom of this comment and
this thing that Gil is trying to distinguish between harms and wrongs
— I'm not sure of the language I would use — there are ways of
mistreating people even if you don't hurt them, even not laying a
hand on somebody.
And I don't think it's
egregious. I think by and large people do a pretty good job. I'm
inclined to think that because the ethics has come through the law,
through the regulations that we now have acquired a system which
doesn't really do what it's supposed to do, but I think that
before you simply say what we really have to do is get out of the way
and let the research go forward, we shouldn't lose clear sight of
what is the ethical good here in addition to harm. That's terribly
important whenever human beings use other human beings for purposes
that are not somehow intrinsic to that relation, and especially with
children who we have to somehow give consent — I'm talking about
small children — have to give consent for their being your objects.
However much you pretty it up, that's
the fact of the matter, and I think that's a reluctance on the part
of parents, and it's not because they're hostile to science,
suspicious of scientists. They have something vital to defend. They
don't even want their children to be subjects of voyeuristic
I serve on — the IRB I served on was
actually in the social sciences division of our university where — if
anybody reads the transcript I'll be flogged when I get back — no
one can make the argument that the research being done there is of
immediate and important humanitarian benefit to anybody.
DR. KASS: They don't try to make that.
They try to say they want to understand certain things maybe in
the long run, and people were scrupulous to a fault about things
that I thought shouldn't bother anybody, but when you start
talking about taking children under 2 and 3 and even 4, for certain
kinds of yearly observational studies where there's no harm
at all, you're wondering what is your attitude to the child
and what are you subjecting him; what are you thinking about in
It's those kind of softer things that
pale in comparison to the real value of finding cures for Wilton's
tumors, but I don't think the people like Paul Ramsey who are
concerned about these things were — I think they were onto something,
something very important. It didn't depend on a theological notion
of childhood innocence.
I think you can give an account phenomenologically in terms of
the experience of being a parent into whose care this new life has
been entrusted, and what are you willing to subject them to and
for what purposes.
I'm not sure I've done it very
well, John, but I think in your writings and your thinking you've
spoken more richly about this than you have in the presentation to this
point, and I wonder what you say.
DR. LANTOS: Thanks for pointing out what
seems like a contradiction although I think is partly contextual, that
is, both where it's at in the article and to whom that paper was
addressed in a pediatrics journal.
I think a lot of the problem for most
pediatrician clinical researchers is they don't see why any sort of
regulation ought to be applied. Hey, I'm a good person. I'm
just trying to do what's best.
And so I strongly support the need for
rigorous oversight of research involving children for the reasons in
that article and because I think things like the inclusion benefit only
apply if there is rigorous clinical oversight.
But at the same time, I mean, I guess I
should throw the question back to you in a way, but in my opinion, we
have developed a stringent set of regulations that would prevent most
of the risks, most of the harms. The wrongs, I guess I don't quite
understand that concept yet. So that may be where we'd at least
have to talk more to see whether we agree or not.
But I think this regulatory framework
with its ambiguous terms of minimal risk and minor increase above
minimal risk is quite restrictive, takes into account what we owe the
children in terms of protection, what we owe the parents in terms of
explanation, getting their permission, their fully informed permission
and the child's assent when the child is old enough to assent, and
that those kinds of protections adequately address the major risks that
you'd get to in treating the child solely as a means to the
creation of generalizable knowledge.
The challenge today, it seems to me, is
more one of figuring out how to apply those in ways that people would
agree upon, and I mean, I think what will happen here tomorrow when you
discuss an actual case protocol is people around this table will have
differing interpretations of what those concepts mean, and you may find
them inadequate to address some of the things, but in the end, you
know, you'll take a vote and it will be eight to six on whether
this protocol should be allowed to go forward or not.
And the discussion that you'll have
will be quite illuminating and important, and then maybe in this one it
will eventually get published, but it will have no precedential
effect. It will have no regulatory effect. It will be sort of your
opinion or this group's opinion or the President's
Council's opinion and people will be free to agree with it or
disagree with it, and that's been happening now for 30 years.
And so we have these concepts.
They're applied daily in pediatric centers across the country, and
the same issues keep coming up again and again, and we don't get
anywhere. So if there are errors of overprotection or denial of access
or if there are errors of enrolling children in protocols where they
ought not to be enrolled, we don't know it, and we only find out
about it in the sort of egregious cases that end up, you know, with the
death of a subject or a lawsuit, and bad cases make bad law or bad
precedent of any sort.
But all of the good deliberation and all
of the casuistry, all of the case based reasoning about what a minor
increase over minimal risk means and sort of a system in which the best
insights can be reviewed, scrutinized, modified, and generalized so
that all children benefit from them doesn't exist now.
Is that sort of an answer? I mean
it's kind of —
DR. KASS: Let it be. It's okay.
DR. LANTOS: Okay.
CHAIRMAN PELLEGRINO: Dr. Foster and Dr.
DR. FOSTER: Let me change the direction
for just a second. In your presentation there are two things that seem
to me to be a little bit — I'm not sure which way you want to go.
The last thing you said was — and I think I used to chair an IRB
myself like Paul and so forth — you said, well, probably a compliance
officer could do 90 percent of the work or 95 percent of the work just
to be sure that, you know, the Ts are crossed and so forth.
And then, on the other hand, earlier you
said that it might improve the system if we had some sort of I think
you used an analogy like an appeal court or something in which there
would be an increase in transparency, and it may be some way that
decisions could be passed on.
I want to understand a little bit more
how you think that that court could be done and a word about does the
fact that most of the things that using the compliance officer would
mean that you could have the freedom to have people serve on such a
court about assessments and so forth.
And finally, if you've given any
thought at all about how one might come up with the money to do this.
One of the questions is whether the
appeal court is going to be sort of locally or whether there's
going to be some published thing like a lawsuit or an ethics journal or
something that would come there. I just wanted to hear a little more
about that aspect, which I don't think we've heard suggested by
DR. LANTOS: I don't think it should
be local. I think it should be regional or national. So whether
it's — and I think it should have regulatory teeth. That is, once
the decision is published, it becomes binding regulation. That is an
interpretation of whether giving injections of placebo to somebody in a
randomized trial of growth hormone is minor increase above minimal risk
or not could be adjudicated. People could disagree.
But it doesn't seem like it serves
anybody's interest to have sort of ongoing, never ending
disagreement that never gets resolved in a way that has regulatory
So let's work on this together
societally. If there's a debate, have the debate. Come up with an
answer sort of like the Supreme Court comes up with an answer. You may
like it; you may not, but once they speak it's done, although you
can bring another case that readdresses some aspect of the issue if
How would it be paid for? I mean, the
only way to pay for it would be out of tax dollars. I guess you could
imagine user fees or something, but some collective subsidization of
this as an important societal function.
What it would do, I think, would be to
make explicit the expenses that are implicit in IRBs and their
CHAIRMAN PELLEGRINO: Dr. Gazzaniga.
DR. GAZZANIGA: I don't want to leave
Paul alone and into the day open-ended questions. Dr. Levine, that was
a terrific talk, I thought very illuminating, and I want to go to
Leon's question, if I may, and try to look at this wrong-harms
issue because it's a tough one to get your head around mainly
because I guess we're not dealing with two or three examples here
that drive the point home.
But let me try something out on Leon. I
want to see if he will see where I'm going and see if this might
help illuminate it. Are we not talking there about Leon when he's
talking about caring for his child, that it's the theory that Leon
has in his head about the well-being and caring of his child that is
being really dealt with in this psychological situation because the
child is obviously oblivious to 99 percent of what's going on here.
So what we're dealing with is your
theory of how all of this should transpire, and the harm or the wrong
has to do with the potential theory you come up with about what might
have transpired or what kind of future psychological damage may occur
from the clinical trial you're in.
And it's so hard to deal with that
because let's imagine I was your son and I grew up to be who I am.
I would want you to put me in a clinical trial because hanging around
the medical community, you really realize how hard it is to do medical
research, completely difficult enterprise.
And I'll use as an example one that Paul can relate to. I
was once at a medical center with two of the world's leading
neurologists who could not agree to do a randomized trial on the
efficacy of coumadin because one of them simply refused not to give
it to his patients.
And so here we have adults all worrying
about a clinical issue that should be resolved and still hasn't
been resolved as far as I know, and it's hard to get it off the
ground. It's hard to do it with adults.
And now we're going down to
children. It's hard to do the research that is crying out to be
done. So what I'm suggesting is in trying — I'm really
asking a question — in trying to think through this harms-wrongs
issue, are we talking about you or are we talking about the wrong to
the child or only your theory about the wrong to the child that
you're carrying around in your head?
DR. KASS: That's in contrast to the
theory of you're running around in your head about the difference
between your head and mine.
DR. KASS: If it comes down —
DR. GAZZANIGA: I guess where is the
locus of the wrong?
DR. KASS: No, it's late in the day,
and I didn't come prepared for this. My friend Robby will help me
out, but let me fish for something for a moment.
By the way, I don't deny for a moment
the importance of the research of its value. I mean, if you're
going to treat children, you should know what you're doing. If
you're going to treat anybody, you should know what you're
doing. And there's no substitute for good science to learn how
that is. We don't have a disagreement about that.
The question is whether we make things
easy for ourselves in doing that work by blinding ourselves to certain
aspects of those human relations in which the people who we hope
eventually to benefit are for the time being at the very least — and
forgive me — to make the point luridly, they are our guinea pigs.
It's not a nice way to put it, but
they are experimental subjects for the gaining of this knowledge, and
we can dress it up any way we like, but that's part of the essence
of it, and it's much better if you're going to do it to have
that clearly in mind.
And by the way, I do think that the
regulations were in a way designed with part of that clearly in mind,
and they are meant, in fact, to protect against the mere treatment of
people in this way and to make sure that the harms to which they are
exposed are minimal and justifiable in terms of some kind of benefit,
however much you try to do that.
But you in a way raise a larger question
about ethical conversation altogether. I advance some suggestion that
there is a way to do wrong to a person without doing them bodily harm
or psychic harm, and you want to know is this my peculiarity. I'll
But part of what you do in these
conversations is you try out certain arguments and examples in the hope
that you're not just talking about your own nervous system, I mean,
because we're looking for a kind of collective wisdom on this.
Now, I give you a biblical example, which means I'm going to lose
with you right away, but —
DR. KASS: — but a wonderful story of
drunken Noah and his sons. Noah has three sons after the flood, you
know. The poor man, it's an ordeal. He planted a vineyard. He
drank of the grape. He got drunk, and he lay naked in his tent.
And one of his sons comes in, sees the nakedness of his father, and
goes out and blabs to his brothers. Now, it's a trivial story
in some respects. I think it's a profound story. The son who
goes and uncovers his father's nakedness and blabs about it
has participated in the unfathering of his father. He has ratified
that and celebrated that without laying a hand on Noah's head.
He has committed an act of metaphorical patricide.
The father lies there no longer as a father. He's just drunken
sower of seed, and the son reveled in it. The two other sons walked
backwards with a cloak on their shoulder and covered the father's
nakedness, refusing to participate in it.
Now, there's no harm in the sense of
bodily harm. Yet there is a wrong. That would be a suggestion.
And part of it seems to me what we want
to do in our interpersonal relations is to somehow look upon people,
never mind talk to them, even the way we look upon them, the way we
speak to them, the way we relate to them, to somehow do honor to the
human person that's there.
Those things are at least as important, I
think, to all of us whether we would immediately recognize it or not as
finding the cures for the diseases that afflict us.
I'm sorry, Mr. Chairman. I rose to
CHAIRMAN PELLEGRINO: Oh, no, no, no.
John and then Dr. George.
DR. LANTOS: I have a clinical analogy to
the Noah story. I mean, in the growth hormone trials one of the
aspects of the trials was annually they'd take nude pictures of the
kids in a trial on the, you know, background so they could measure arm
length, and they'd cover their eyes with black tape, and one of the
big debates in IRB review of this was, you know, was this portion of
the study necessary was one question, but harm or wrong or sort of
unacceptably demeaning so that it should be negated.
I think that's an important debate.
So in that sense I think there are wrongs that can be done that
researchers could propose that would be important for the study. I
mean, all of the endocrinologists said crucial, crucial information if
we're ever going to evaluate the results, and I think people should
have debates and discussions and decide, given what the goals of the
study are, is there a less invasive way to find it out? How important
is it? And ultimately come up with a judgment about whether it's a
good thing to do.
But I don't think every center every
time this is proposed should have to debate it again and again and come
up with their own idiosyncratic result that's then binding without
having to explain how they got to the conclusion that they got to.
That's all I'm trying to say.
CHAIRMAN PELLEGRINO: Dr. George.
PROF. GEORGE: Well, yes. Thank you, Dr.
I was originally jumping out of my chair
to defend Leon from Michael's question, but Leon proved with that
eloquent statement that he certainly doesn't need my help or
anyone's help in defending his views on this very, very important
issue about the nature of wrong and its relationship to harm and the
possibility of there being wrongs that aren't strictly harms.
So instead of jumping into Leon's
defense since he doesn't need it, let met just toss something on
the table for Leon and Michael to maybe think about.
Does it in the end come down to whether
one's essential view of benefits and harms and of those creatures
who are capable of experiencing benefit and harm in the human way, does
it come down to whether benefits and harms are in the end material or,
if not material, psychologistic realities or whether there is some
category that is distinct from the material or merely psychological of
human good and, therefore, of the privation of human goods that can be
offended and thus a wrong done to a person in whom the good is
And to test that, I might try an example somewhat different from
Leon's biblical story since it will put it into the context
of research and, indeed, pediatric research, and I also think somewhat
different from the example that Dr. Lantos just raised about the
children who were photographed in the nude, and that would be something
Imagine that you are the parent of a severely retarded child who is
also spastic in some ways and you had a research team that was seriously
interested in understanding the phenomenon of other children ridiculing
retarded children who are spastic, and so an experiment was designed
reasonably under the terms of which retarded children were put behind
a one-way mirror and other children, ordinary children, were invited
to come in and we could see which ones ridiculed the child and laughed
at him and made fun of him and so forth and so on, and you as the
parent were asked to volunteer, contribute your retarded child.
Now, the retarded child, let us
stipulate, is not going to know this ever went on, is not going to know
that he was ever ridiculed, jeered at by these people, doesn't know
anything about the reason for it because he doesn't know it's
happening at all.
Now, on a certain non-materialistic and non-psychologistic account
of the human good, that child, if the parent volunteers, is participating
on at least — it's reasonable to think, it would be a
reasonable view — that that child is being subjected to a
But on a view that really restricts the
scope of our understanding of human benefits and their privations to
the material or at least the psychologistic, it becomes puzzling at
best and probably kind of superstitious to suppose that that child has
been subjected to anything that could qualify as a wrong.
CHAIRMAN PELLEGRINO: Paul.
DR. McHUGH: Surely the children that are
being encouraged to make fun of him have been done a serious wrong, and
PROF. GEORGE: Well, let's stipulate
that they're not being encouraged to. In other words, we're
bringing in perhaps a randomized group of children because we're
going to try to figure out what it is about backgrounds and so forth
that leads some children to ridicule and perhaps other children to look
with pity or sympathy of some sort on him.
So we're really sincerely trying to
figure this out. I mean, it sounds to me like not an unreasonable — I
don't do this kind of work. So I don't — so, I mean, it
doesn't seem to me that that's an unreasonable way of
structuring an experiment if we factor out the ethical dimension of the
DR. LANTOS: In some ways we have an
investigator at our place who is trying to study how pediatric
residents' attitudes towards children with severe disabilities are
formed or changed over the course of their pediatric residency, where
the equivalent to the other children who are being brought in in your
hypothetical study are the attending physicians who are hypothesized to
be the ones who sort of teach the residents their attitudes.
So I guess the question would be: Would your judgment of that
sort of study depend on the goals? I mean, if the goal of the study
was to develop educational interventions that could sort of change
discriminatory attitudes to the better, and therefore, the research
was designed to improve lives for all children with severe disabilities,
would that be different than, you know, if the goal of the study
was to see whether catecholamine levels rose in the child who was
being, you know, treated in a disparaging way?
PROF. GEORGE: Well, I think that is a very
interesting and perhaps important distinction, but it wouldn't be a
distinction that would be relevant to our getting at the question of
whether there could ever be a wrong that's not a harm in
materialistic psychologist terms.
DR. LANTOS: Right. It would take the
next step of asking whether there could — we had acknowledged there
was a harm. The question would be could there also be a benefit that
balanced the harm.
PROF. GEORGE: Sure. It would open a range
of questions. I agree.
DR. GAZZANIGA: I remember going back
three years — how long have we been doing this? It's four and a
half — and I remember talking to Paul. The Council was talking about
human dignity and you know how you rotate us so that there's no
DR. GAZZANIGA: Anyway, so I was sitting
next to Paul and someone was going on about human dignity, and I turned
to him, and I said, "Paul, you work in a hospital. I've
worked in a hospital. There's no human dignity in a
Can I quote you?
And you said, "You're damned
right there's not. The first thing you come in and you tell a guy
to drop his pants, get on the table. It's terrible. You check it
at the door."
So there's a context. I mean
he's being his usual humorous self, but there's a context, and
what is being undercut here, and I think what you were trying to get at
is the guild of physicians have under oath the patient's best
interests in mind, and I think 99.9 percent of them practice that.
And we have this whole apparatus around
produced by rogue doctors that have made us supersensitive to some
issues and are having the result of not allowing solid research to go
And I think that to footnote that, I think the concept of a non-physician
bureaucrat running an IRB is the worst idea I have heard this year
because you will take away from, it that matter, the whole understanding
of the medical mission and the whole understanding of medical research
and the whole caring function in a way that is truly interpersonal
between a physician and their patient.
So what I'm saying is that if you
look from the real context of medical research knowing that dignity has
been challenged by the very nature of our medical procedures, but on
the other hand, balance that out with the commitment that all
physicians have made, these questions that we're talking about take
on a different color and a different meaning, and I think they're
hard to talk about in the aseptic sort of non-medical environment that
we're holding this conversation.
There's something in there somewhere.
DR. LANTOS: I think it doesn't
matter whether it's a physician or non-physician. All of the good
things you just described have been taken away by the definition of the
role. So the physician who does it can no longer pay attention.
But the idea of responsible investigators being punished because
of the transgressions of the rogues I think is an important idea,
too. I mean, I think while there are conflicts of interest for
investigators and people build their careers, and there's fame
and fortune to be made by doing good studies. There is also, I think,
the moral imperative generally to gain knowledge in order to improve
care of children as part of that very mission of the medical profession,
is, I think, an important part of the motivation of most clinical
researchers, and the sole motivation for many of them.
I mean a lot of the people I know who are
trying to do good clinical research aren't going to win any Nobel
Prizes. They're not getting famous. I mean, they get a paper
every couple of years, but their motivation is to take better care of
their patients, and in the care of their patients, they come across
unanswered questions that can be answered by good clinical trials, and
often the clinical trials raise the kinds of issues that we're
talking about today, and the regulatory apparatus puts roadblocks in
front of those responsible investigators that I think often don't
protect subjects, in fact, leave subjects exposed to all the harms of
nonvalidated therapy, even though it's carried out by unconflicted
though necessarily ignorant, well meaning physicians.
CHAIRMAN PELLEGRINO: Thank you very much.
We're finished our time.
(Whereupon, at 5:17 p.m., the meeting was
adjourned, to reconvene at 8:30 a.m., Friday, April 21, 2006.)