TRANSCRIPT: Meeting Six, Session 2

Historical Investigation -- Ethics Standards and Practices

Date

August 29, 2011

Location

Washignton, DC

Presenters

Commission Members

Download the Transcript

Transcript

             

            DR. GUTMANN:  So that's a good segue, right?

  We are going to talk now in this session addressing

  directly the ethical standards of the day and, in

  particular, here are the questions we want to address.

            Did the researchers try to keep the

  experiments secret?  What standards did the researchers

  employ to protect human subjects in an earlier

  experiment conducted in Terre Haute, Indiana, in a

  federal or state penitentiary there?  I think it was a

  state penitentiary, I think, state.  What about in

  Guatemala, how did the protections of human subjects in

  Terre Haute compare to the protections in Guatemala?

  And what standards were available at the time for the

  protection of human subjects?

            And I've asked Anita Allen to begin by a

  summary of what the answers to those questions are and

  then we will open it up again for discussion and again

  if there are any members of the public who have -- we

  didn't receive any questions in the last session but if

  there are any questions that you want to jot down on

  cards and deliver it up here, we welcome that.

            Anita Allen, can you begin our discussion,

  please?

            DR. ALLEN:  Thank you, Dr. Gutmann.  The first

  question you raised was whether the researchers tried

  to keep the experiments secret and that question raises

  another question which is why do we care?

            Well, we care because secrecy sometimes

  signifies mindfulness of wrong-doing and a desire, a

  selfish one, to avoid ethical accountability.

            Yes, Dr. Cutler and others did try to keep

  complete information about the research protocols

  involved in the experiments out of the hands of agency

  officials, agency oversight officials, scientific

  peers, the general public, and the research subjects

  themselves and on this count, the researcher's own

  words tell the story and I think some would say condemn

  them.

            In a letter in 1947 to his colleague, Dr.

  Mahoney, Dr. Cutler confided that it would be advisable

  to not have too many people concerned with this work in

  order to keep down talk and premature writing and Dr.

  Arnold expressed concern in 1947 that "some goody

  organization might get wind of the work and raise a lot

  of smoke."  So people involved were definitely very

  aware of their own efforts at concealment.

            In 1955, looking back on the experiments, Dr.

  Cutler admitted that efforts had been made during the

  Guatemala years to confine knowledge to as few people

  as possible.  I quote him directly.  "It was deemed

  advisable to work so that as few people as possible

  know the experimental procedure."

            As the principal investigator, he clearly

  wanted to avoid ethical criticism, to avoid

  interference, and any political barriers to his work.

  He even at one point said he wanted the research to be

  "guarded and subterranean."

            So to maintain Dr. Cutler's secrecy, he and

  Dr. Mahoney worked hard at keeping reports away from

  those who would normally get them.  They adopted a set

  of procedures that involved bypassing the normal

  oversight officers in the agency and instead Dr. Cutler

  would send everything to Dr. Mahoney who had promised

  to keep things secret and when there was a requirement

  to post a summary or report, Dr. Cutler offered what he

  termed "barest summaries of our progress."

            It's already been noted that Dr. Cutler's

  final reports and results of the STD experiments were

  never directly published.  He himself, Dr. Cutler

  himself sometimes seemed to insert little references to

  his own research in some of his papers but they were in

  a highly-disguised form, again trying to keep things

  secret.  So, yes, there was a lot of effort to keep

  this stuff secret.

            But in a way, we got to this point a little

  bit earlier, the research was not secret.  Framed as an

  STD prevention and treatment research project, the

  research was funded by the U.S. Public Health Service's

  Venereal Disease Division and its Venereal Disease

  Research Laboratory which is now part of the Centers

  for Disease Control and Prevention.

            The research was conducted pursuant to open

  agreements executed between the nation of Guatemala and

  the United States.  Many public officials,

  institutional directors, physicians, researchers, were

  aware of the broad outlines and research protocols.

  Evidence shows that Guatemalan officials, including the

  Ministry of Public Health, were aware of and supported

  the research.  The research staff for the experiments

  included the National Psychiatric Hospital in

  Guatemala, National Orphanage, Chief Army Medical

  Department, as well as the Director and Assistant

  Director of the Venereal Disease Research Unit, and

  numerous other medical and scientific staff from that

  office.

            So while secret in one respect, in another

  respect this was by no means a secret matter.

            Indication of lack of secrecy, and an odd one, is that Dr.

  Cutler did choose to keep his records.  He didn't burn

  them.  He kept them and then in 1990 he donated them to

  the University of Pittsburgh Archive where they sat and

  others might review them which, indeed, happened in the

  case of Dr. Susan Reverby who brought those records to

  light very recently.

            The second question was about whether what

  standards were applied or employed in the protection of

  human subjects in the Terre Haute Prison Experiments in

  1943 and '44, an important question because what the

  Terre Haute project shows is that some of the same

  researchers, Drs. Mahoney and Cutler and others,

  involved in STD research just a year or two earlier

  than Guatemala did in fact show some regard for human

  subject research values.

            So just prior to Guatemala, research was

  conducted by the Public Health Service at the Federal

  Prison, Terre Haute Prison, and this was research that

  was done in collaboration with and in cooperation with

  the U.S. Bureau of Prisons.

            The purpose of the research was to identify

  chemical prophylaxis against gonorrhea, so as to

  protect men in the Armed Forces from the disease in

  order to protect military readiness at the time.  It

  was believed that something like seven million man

  hours were lost every year due to gonorrhea at a cost

  of about $34 million for treatment.

            So there were 241 prisoners who participated

  in the experiments in Terre Haute and these men were

  inoculated with strain concentrations of gonorrhea

  where the bacteria was deposited into the end of their

  penises, as described earlier by my colleague.

            The experiments were discontinued, however,

  only 10 months after they began due to the inability to

  reliably infect the men in spite of different strains

  of gonorrhea and different modification methods of

  inoculation.

            So by the end of this particular experiment,

  the researchers sadly concluded they had learned very

  little and that they still didn't even know whether the

  35-year-old silver protenate that they'd been using was

  actually effective in preventing gonorrhea.

            As for what standards were used, there were

  two main standards that were employed to protect those

  241 U.S. prisoners:  risk minimization and informed

  autonomous consent.  Risk minimization measures

  included situating the research at what at the time was

  the very best federal prison in the nation, the one

  with the best medical facilities I might say, and here

  you have a captive population, but people were able to

  get good medical treatment.

            When it came to informed consent, in this

  instance the prisoners were actually volunteers and

  they were given a written informed consent document to

  use to waive their rights and the document did make an

  effort to explain to them the costs and benefits and

  nature of the research.

            The project, they were told, would study the

  effectiveness of two types of prophylaxis against

  gonorrhea and that with that information in hand, the

  men could perhaps make a better decision about whether

  or not to participate and they weren't over-induced.

  The men were paid but they weren't paid so much that

  they would do it as it were sort of compelled to do it

  to get the money and while they were offered a

  certificate of merit at the end of the research and a

  commendation to the Parole Board, they weren't promised

  early release from prison as a condition of

  participation.

            So risk minimization and informed consent or

  autonomy were respected in the Terre Haute U.S.-based

  experiments, even though we see in Guatemala those same

  values and norms were not respected.

            In Guatemala, the same researchers did not

  offer their subjects informed consent and did not make

  a serious attempt, I would argue, to minimize risk and

  the subjects included some of the most vulnerable

  people one could imagine:  soldiers in active duty,

  prisoners in prisons and jails, sex workers, some as

  young as 18, children, people with leprosy, people with

  epilepsy, people with mental illnesses, indigenous

  Guatemalans, so-called Indians, poor people, uneducated

  Latinos.  This is the population of people that the

  United States Public Health doctors went to Guatemala

  to use as subjects for their research and they offered

  them none of the same protections that were offered to

  the U.S.-based research subjects in Terre Haute.

            Why Guatemala?  I think I've pretty much just

  said it.  Because the population was available and

  vulnerable, powerless, but there were other reasons, as

  well.  There was a Dr. Juan Funes who was a Guatemalan

  physician who had worked for one year as a fellow with

  Drs. Mahoney, Arnold, and Cutler at the Venereal

  Disease Research Center in Staten Island in 1945 and he

  suggested the United States doctors go down to

  Guatemala.  He had a clinic there that he worked in and

  that was made attractive by the fact that there was

  already a preexisting relationship between the U.S. and

  Guatemala to provide medical services and to develop

  public health facilities down in that part of the

  world.

            The U.S. went to Guatemala bearing gifts of

  medical infrastructure and some medications that were

  scarce and expensive.  The U.S. researchers felt they

  would be able to employ some protocols they would not

  be able to do in the United States.  It wouldn't pass

  muster with the U.S. ethical standards and also I

  should note that in Guatemala, the use of prostitutes

  was less troublesome because there it was both legal

  and there was a provision of routine public health

  examinations of the sex workers.

            So in Guatemala, no informed autonomous

  consent.  The subjects were not told about the goals of

  the study, the purposes of the study, the methods, the

  risks, or the social benefits that might be involved.

  The subjects included people who were well under 21

  years of age, children, schoolchildren, and orphans,

  and their parents were not offered informed consent and

  the children were not offered informed consent either.

            The subjects included prisoners, mental

  patients, and others with lack of cognitive

  competencies.  The subjects included people who were

  actively ill, people who were sick with chronic and

  acute diseases.  They were nonetheless included as

  research subjects.

            Superiors could force inferiors to participate

  using deception about the purposes, about the risks

  involved, and, of course, we had here very, very

  disenfranchised people in general, people who just

  didn't have the same education, knowledge of science,

  medicine, and so forth that the public health doctors

  had.

            Very, very few risk minimization measures were

  put into place.  I think it even violates our sense of

  human rights, what went on in Guatemala, not just the

  lack of informed consent, not just a lack of research

  minimization of risk, not just lack of privacy and

  autonomy, but actually cruel and inhumane conduct took

  place, abrading, scarifying, exposing to bacteria, to

  meningitis, to neuro-syphilis.  These are very, very

  grave human rights violations and I think we'd have to

  all agree.

            So there was not the same level of protection

  in Guatemala that was offered to subjects in the United

  States.

            What were the available standards at the time?

  What ethical standards might the researchers have

  relied upon?

            Well, to start off with, they could have

  relied upon ordinary morality and conscience.  Those

  were available. But such standards that we all learn at

  our grandparents' knees were not followed.  Why weren't

  they followed?  It's really impossible to say, but it

  seems as though, seems to me personally as though the

  researchers put their own medical, scientific and

  personal advancement first and human decency and

  respect for others a far, far second.

            These experiments could not be approved under

  contemporary regulations for human subjects research.

  Informed consent today is key.  Risk minimization is

  key.  Respect for vulnerable groups is key.  But these

  ideas were not unheard of in the 1940s.  They were in

  circulation and the researchers could have turned to

  them.  We know they knew about them because they

  employed them in Terre Haute, Indiana, just a year or

  two earlier.

            We also know that it was the time of the

  highly-publicized Nuremberg trials in the 1940s, 1946,

  the American research community was highly mindful of

  the fact that 23 doctors and bureaucrats were being

  accused of involvement in very cruel concentration camp

  experiments in the Nazi Third Reich, and coming out of

  the international attention shined on the Nazi doctors

  and their collaborators were principles of informed

  consent and respect for vulnerable people that were,

  indeed, published in the Journal of The American

  Medical Association in 1947 and these principles

  included a principle that there must be consent of a

  human subject in all cases.

            Everyone has to consent.  Coercion is not

  authorized or not appropriate.

            And, finally, there was a need to be concerned

  about the avoidance of unnecessary physical and mental

  suffering, according to the Journal of The American

  Medical Association principles and these experiments in

  Guatemala involved a lot of needless and cruel

  suffering, both physical and mental.  A lot of

  people who were experimented on were terrified, were

  avoidant but were nonetheless coerced, both emotionally

  and physically coerced to participate.

            So we have the Terre Haute background

  providing us values.  We have the post-Nuremberg

  principles that were promulgated in major journals

  providing some guidance.  We have common sense and

  ordinary morality providing guidance and we also have a

  sense at the time that the media was promulgating and

  reflecting current values.  So there's a newspaper

  article from the New York Times in 1947 that our

  preliminary report, our draft report cites, a

  journalist called Walter Canford, who reported on STD

  research involving animals, and he said that it, of

  course, would be ethically impossible to shoot living

  syphilis germs into human bodies.  It would be

  ethically impossible.

            Well, little did he know that down the road,

  this exact thing was happening with human beings but

  it's inconceivable to this major media journalist that

  such a thing could be done.  Why did he think that?  I

  think probably because most people thought that at the

  time.

            So, you know, in conclusion, there was

  definitely not the same level of federal public law

  that there is today to guide scientists.  There wasn't

  the same level of formal professional documents laying

  out printables.  There was no detailed ethical code for

  doctors and researchers as there are today, many of

  them today.  We had no Belmont principles yet and so

  forth, but we did have, I think, enough ethics in the

  air and in society that would have instructed the

  Guatemalan researchers to do differently than they did

  and I'll stop it there.

            DR. GUTMANN:  Thank you very much.  There's an

  important distinction in ethics between whether

  something is morally wrong on the one hand and on the

  other hand whether the people who conducted what was

  morally wrong are morally blameworthy and we as a

  commission need to address both those questions.

            It's in retrospect but it is to actually come

  to terms with our history and to honor the people who

  were subjected to what was clearly in our minds as a

  commission morally wrong.

            I would ask any members of the Commission, if

  you would, to say something not only about the moral

  wrongs in this case but about how one assesses -- and

  this is not for the sake of legal judgment.  We are not

  sitting -- we're sitting as a bioethics commission.

  This is -- but as a matter of intelligence, ethical

  assessment, to what extent was there moral

  blameworthiness in this case?

            And let me start with John Arras.

            DR. ARRAS:  Thank you, Amy.  I spent a lot of

  time pondering this very question.  As my fellow

  commissioners know during our e-mail conversations,

  I've been fretting about this distinction between blame

  and wrong-doing for quite some time and in large part

  this stems from my own teaching and research where, you

  know, I canvass the history of the Nazi experiments

  and, you know, experiments done in the U.S. without

  consent and I'm acutely aware of the rather dramatic

  shift in values and perspective that was beginning to

  take place around that time.

            So I think that it would be a case of what my

  colleagues in history call presentism, in other words,

  imposing the views of the present on the past, to view

  these physicians in exactly the same light that we

  would view people today who did these things, and I

  think that this is especially true with regard to

  informed consent.

            Even though Andrew Ivey at the Nuremberg

  trials said that informed consent was an absolute

  bedrock of medical experimentation, in this country I

  think that he was exaggerating by a long shot.  This

  was a time, this was the heyday of physician discretion

  in medical ethics and medical research, and the debate

  over the moral necessity of informed consent lasted

  well into the 1960s and '70s.  So there were people on

  both sides of that debate.

            So I, for one, have been extremely reluctant

  to bring the moral hammer down, you know, with full

  force on the question of blame.

            However, the issue of informed consent is not

  the only question and even on the issue of informed

  consent, we're not simply talking about failure to

  inform.  We're talking about active deception, right?

            But apart from informed consent, we have all

  these issues about not subjecting people to needless

  suffering, not imposing risks upon them that can't be

  justified by the scientific study, and once we add all

  of those issues into the account, I really do believe

  that a very vigorous judgment of moral blame can be

  lodged against some of these people.

            For me, the most powerful argument that can be

  made here is to repeat a story that's in our report and

  this is the case profile of a patient named Berta.

  This is given on Page 117 of our report.

            So Berta was a patient in a psychiatric ward.

  She was injected with syphilis and not given penicillin

  until three months after her infection, but here's the

  interesting part, and I'm just reading here from the

  profile.  Soon after, on August 23rd, Cutler wrote that

  Berta appeared as if she was going to die but he did

  not specify why.  That same day, he put gonorrheal pus

  from another male patient into both of Berta's eyes as

  well as in her urethra and rectum.  He also reinfected

  her with syphilis.  Several days later, her eyes were

  filled with pus from the gonorrhea and she was bleeding

  from her urethra.  Six months later, she died.

            I would submit that this kind of case cannot

  be waved away by even the most acute awareness of

  fluctuation in medical ethics standards of the time.

            DR. GUTMANN:  That's why I think we stand by

  the view I earlier articulated, that if Berta was

  considered treated like a human being, nobody, not

  a -- and most especially not a doctor could have

  treated her like that.

            DR. ARRAS:  The only thing I would add to that

  is that -- and a comment that was made at the time of

  the Nazi trials was that if they had only treated the

  subjects of those studies as well as they treated

  animals in their studies, there would have been no

  scandal, and I think we can say the same thing of this

  study.

            DR. GUTMANN:  That's why I earlier said things

  rather than other animals.  We are higher, you know,

  but sometimes lower.

            I would just add -- could I just make one

  comment because it is our -- this is on

  the -- Christine Grady earlier said, you know, some of

  the science was not useless and I will defer it to

  that.  That may be true, as it was true of some of the

  Nazi science.  There is something worse than doing

  useless science.

            DR. FARAHANY:  So, first, Anita, thank you for

  that again very sobering account of the ethics of the

  research.

            To your question, Amy, about blameworthiness

  versus wrong-doing, I likewise struggled with this

  quite a bit because one of the difficulties in

  retrospective judgments of ethical conduct is, first,

  that it is retrospective, but, second, understanding

  what the researchers knew and understood at the time.

            But we don't really have that problem here in

  a way that we do often in retrospective judgments and

  so I teach both law and philosophy and I in fact teach

  a comparative class on the difference between

  responsibility, liability and blameworthiness, and

  whether it's in law or in philosophy, one of the

  hallmarks of thinking about blameworthiness of

  individuals is knowledge of wrong-doing and acting with

  knowledge of wrong-doing.

            We don't -- because we can't directly ask or

  find out what the knowledge was at the time, we use

  objective evidence to infer what the subjective intents

  were at the time and we have a lot of that from the

  Terre Haute studies that Anita recounts and the

  knowledge that they were acting under from the

  contemporaneous documentation, the desire to keep

  things secret, the back and forth letters that were

  exchanged suggesting a need to avoid the political

  consequences of the study.

            All this was done with knowledge and

  understanding of the ethical limitations and so the

  only thing that for me was something I wanted to ponder

  as a potential mitigating circumstance was is there

  something different about international research

  standards at the time than there was about domestic

  research standards because obviously they understood

  what the domestic context was, having Terre Haute, but

  is there something different about a partnership with

  another country where, for example, we know that

  commercial sex workers were not outside of the norm

  there, weren't considered to be, you know, an ethically

  impermissible use, and so I think there are some things

  that we can say that we wouldn't have done here but

  within the context there would have been permissible

  but very few things in this study that we can say.

            We can say the use of commercial sex workers

  perhaps with everyone's full knowledge and informed

  consent would have been permissible but to

  intentionally infect people, to do so with deception,

  to do so with bad science, to do so in secrecy, to do

  so without actually publishing the reports, all this to

  me suggests very clear objective evidence of subjective

  knowledge of wrong-doing which is sufficient for a case

  of moral blameworthiness.

            DR. GUTMANN:  Raju.

            DR. KUCHERLAPATI:  You know, I'm trained as a

  scientist and I'm a practicing scientist and I'm not an

  ethicist.  So it was very important for me to

  understand and however, you know, I find it difficult

  to be able to put myself in the shoes of those people

  and trying to judge them based upon contemporary

  today's standards.

            We understand what today's standards are, but

  the argument that's most persuasive for me of all of

  the different piece of evidence that was presented is

  the Terre Haute experiments.  I think that the Terre

  Haute experiments were contemporary for that time.  The

  people were specifically involved in those experiments.

  They knew that, you know, that it is necessary to be

  able to obtain consent from patients and they also knew

  that these Guatemalan experiments could not be

  conducted in Terre Haute and the same individuals made

  that statement said that these experiments just cannot

  be conducted in our country.  We have to go out to be

  able to do these experiments.

            So of all of the different sorts of things,

  the three different sets of arguments that we make, the

  one that's most persuasive for me is the ones

  that -- because they have direct knowledge.  It's the

  other types of things, you know, great moral principles

  and, you know, those are in the background that you may

  not be directly be, you know, thinking about them every

  day, but these are very clear.

            And the other thing that's also persuasive is

  the fact that the New York Times reporter writes about

  these experiments and that there are no circumstance in

  which these types of experiments can be done.  He is

  not talking about Guatemala experiments.  He's just

  talking about experiments of the nature that were

  conducted in Guatemala. And so those things, you know,

  make a persuasive case that, you know, clearly that the

  people should have known and most likely have known

  that these are unethical experiments but they conducted

  them anyway and that is what is reprehensible.

            DR. GUTMANN:  Barbara.

            DR. ATKINSON:  Maybe I should introduce

  myself.  I think I haven't the last couple times.

            I'm Barbara Atkinson.  I'm the Executive Vice

  Chancellor at the University of Kansas Medical Center,

  and to me the blameworthiness relates mostly to the

  vulnerable populations and it just seemed like they

  went from not so vulnerable to the most vulnerable,

  getting more egregious every time.

            So at Terre Haute, it was prisoners and it was

  really done pretty well but then they went to

  Guatemala.  The Army people got mostly gonorrhea,

  pretty straightforward gonorrhea studies, but then they

  went to the prisoners there and they started the penile

  abrasions and scarifications in order to get to them

  and then they complained about the blood draws and

  these they called the indigenous Indians and they

  complained about the blood draws and the pain and then

  they went to the psychiatric patients and started doing

  things like cisternal injections and what you just

  heard in John's study.

            So that progression to me seems as if they

  really must have recognized that they were

  getting -- had to get to people that were so vulnerable

  that they really couldn't complain in order to do the

  very worst of the things they wanted to do and I just

  can't forgive that or not see a recognition of blame in

  that.

            DR. GUTMANN:  Lonnie Ali.

            MS. ALI:  Thank you, Amy.  And, John, thank

  you for your comments.  That one patient profile was

  something that really got to me, too.

            I wanted to ask Nelson something because I was

  going to ask a question, Anita went before me, and it

  was the same idea of them being cognizant of what went

  on in Terre Haute and then going to Guatemala and the

  standards perhaps being different there.

            Do you have any knowledge if that is true, and

  how much work was being done outside of the United

  States with regards to using human research subjects?

            DR. GUTMANN:  Nelson, could I just ask you to

  preface your answer by saying a little bit about the

  research just so people know that Nelson does research

  outside of the United States?  So I think that's

  relevant.

            DR. MICHAEL:  Yes.  Yes, and most of the

  research that my organization does is done outside the

  United States in East Africa and West Africa, South

  Africa and in Thailand. We've been doing those kinds of

  studies in HIV since the middle 1980s.

            So because of the fact that the work that we

  do is represented, is funded through and represents an

  agency of the U.S. Government, we really feel like

  there's no difference between the level of ethics that

  would apply to U.S. soldiers as research participants

  or American citizens or citizens of any country and

  that we have extensive review of those kinds of

  research proposals that includes oversight by normative

  bodies, like the World Health Organization, extensive

  involvement of community groups, to include NGOs, and

  representatives of the community in which research is

  done, and that's something I'll probably talk about a

  lot more tomorrow when Christine and I talk about the

  International Research Panel deliberations.

            But I don't think that in this case you really

  have much that's different in that sense.  The Public

  Health Service is an arm of the U.S. Government.  There

  were research standards in the United States that the

  researchers clearly felt like were going to represent a

  challenge to do the kind of work they wanted to do and

  they went elsewhere to do it.

            My own view is I don't think that's ever

  defensible.  I think that if a research is done in the

  world community, it needs to be done in the world

  community, and there's no difference between borders.

            So from a personal standpoint, I don't think

  it's defensible to say that you do research elsewhere

  because it addresses an expediency, and I think that,

  going back to Anita's very careful dissection of

  blameworthiness, these individuals, I think, had a

  pretty clear idea of what they were doing and why they

  were doing it and they were driven by expediency.

            So at that time, if what you're asking me is,

  you know, what was the prevalence of research

  standards or ethics that were codified, I'll tell you

  I'm not aware of any set of standards that would have

  said it's okay to go offshore and do this kind of

  research.  I think they did it because they found a

  doorway that they found darkened and went through it

  and they ended up, I think, for the longest period of

  time getting away with it.

            MS. ALI:  Can I ask you one more question,

  please, Nelson?  In the Terre Haute experiment, one of

  the things that James Bennett was very concerned about,

  he was the Director of Prisons at that time, was not

  giving incentive to the prisoners to participate in the

  study and it wasn't so much because he thought it was

  coercion, he was really more concerned about the rest

  of the population who did not have an opportunity to be

  a part of the experiment.

            Would that be appropriate today?  Would that

  be considered coercion to offer money and perhaps some

  type of recommendation to a parole board, a good word

  per se, to participate in a study?  Would that -- you

  know, we had a little discussion about this beforehand,

  about what is coercion.  Would that be acceptable

  today?

            DR. MICHAEL:  Well, I think that, I'm looking

  over at my colleague Christine, we've been spending a

  lot of time together, we're both on the IRP, but I

  think that when you work in vulnerable populations, you

  are entering into a realm of very great ethical concern

  and I think that to me the bottom line is it matters

  less that you are completely compliant with regulations

  to do what you do with research volunteers of any type,

  but especially in vulnerable populations, I think you

  need to ensure that the broadest possible transparent

  dialogue occurs, so that if all agree that research

  goes forward, that it really does involve a series of

  checks and balances that advocates for the research

  subjects themselves are adequately represented and I

  think that you have to ask yourself, and we were having

  this discussion at lunch about some of the work that we

  have done in Thailand, is what defines an adequate

  review of that kind of work?  What defines an adequate

  engagement with the community?  Who says what's good

  enough?

            So I think that when you're involving

  individuals that, by dint of their circumstance, have

  less intrinsic ability to speak for themselves, I think

  that you really have a moral obligation to do the best

  that you can possibly do but don't rely on simply your

  own judgment or judgment of regulators or boards that

  oversee that process and ensure that they have a voice

  and a powerful voice that comes from the community and

  the volunteers themselves and doing that, I think, in

  those populations is very challenges.

            DR. GUTMANN:  Christine, do you want to say

  something about standards of undue inducement and --

            DR. GRADY:  Yes, I do.

            DR. GUTMANN:  -- from what we know is at the

  time?

            DR. GRADY:  Yeah.  Well, I don't know about

  the time.  I think in response to Lonnie's question, I

  think two really important things to point out and that

  is, we have come to understand in a way that we didn't

  in the '40s and '50s and '60s that prisoners are

  vulnerable for lots of reasons, partially what Nelson

  just said, that they are in a position where it might

  be difficult for them to protect their own interests

  and to say no in the context of research and therefore

  the current rules limit the kinds of research that can

  be done in prisons to a great degree.

            The second question, though, is about

  incentives and what's acceptable and what's not.  This

  is a very controversial area of research and very

  controversial in general.

            I think it is true that many people who are

  participants in research receive an incentive of one

  sort or another.  Sometimes it's money, sometimes it's

  food or soap, sometimes it's medicine that they want

  for something that they are struggling with.  So there

  are incentives that are provided in research all the

  time.

            The debate that continues to ensue is at what

  point do any of those incentives become unduly

  influential to the point where it might distort an

  individual's ability to make a good judgment, to look

  at the risks and benefits and decide for him or herself

  whether or not to join a study and that's really an

  ongoing discussion.

            DR. GUTMANN:  Steve, you might -- we should

  circle back a little bit to the experiments.  You might

  want to say, if I could ask you, on some of the

  experiments on the prisoners, what the nature of those

  experiments were because I think that helps illuminate

  some of the ethical problems here.

            DR. HAUSER:  The details of the inoculation --

            DR. GUTMANN:  Yes.

            DR. HAUSER:  The details of the inoculation

  experiments?  Well, to put more detail on a broader

  discussion earlier, these experiments in many cases

  involved two types of experiments.  One they called

  natural infection which was intercourse or other sexual

  activity with prostitutes, with commercial sex workers,

  inoculated or infected deliberately and instructed to

  have multiple encounters without washing.  They

  involved inoculation by variously-stringent mechanisms

  to try to directly infect prisoners with these diseases

  and, as was said earlier, some of these methods

  actually did cause at least localized infections but

  not the model that they were searching for.

            Was that the type of --

            DR. GUTMANN:  Yeah.

            DR. HAUSER:  -- detail that you were --

            DR. GUTMANN:  Part of -- some of the facts

  that have come out in the historical study indicate,

  and this is why Lonnie's question, I think, is so

  important, indicate that, despite the fact that there

  were something -- there was something offered to the

  prisoners, which is not uncommon, the prisoners

  were -- expressed, indeed, at some points were so

  unhappy with the way they were being treated that the

  doctors were fearful of a revolt and did as much as

  they could to continue the experiments, despite the

  fact that the prisoners who were not asked for consent,

  who were given some inducement, whether it was -- it

  was not large.  It was a $100, I believe.  They still

  were a vulnerable population which is known and was

  known at the time to be more willing to undergo

  experiments.  They were extremely unhappy with the way

  they were being treated.

            So there was again something, to go back to

  Lonnie Ali's question and Nelson's answer, there was a

  sense that these very experimenters, researchers, as

  Nita Farahany has said, knew they couldn't do this in

  the United States.

            Steve.

            DR. HAUSER:  Just a comment, two comments, one

  partially a question, and again I come to this, as my

  colleague Raju also said, that we are not bioethicists.

  We are scientists.

            So I think the first point that I wanted to

  touch on was Amy's question about individual guilt that

  a number of my colleagues have spoken about and it's

  difficult to infer motivation, especially for those of

  us who never met the principals in this trial.

            There is a documentary called The Deadly

  Deception that is available online about a different

  study that Dr. Cutler was involved in, the Tuskegee

  study, and the belated closure of the Tuskegee study

  after people were followed without treatment when

  therapy for syphilis was available and there's an

  interview with Dr. Cutler for the 1993 documentary, an

  old man at this time, and he says that he was furious

  that the study was stopped.  He continued to argue that

  the study was too important to stop.

            It's difficult to infer what someone's

  motivation was 40 years earlier or 35 years earlier,

  but it's hard not to come away with the conclusion that

  this was a person who believed that the ends, that the

  importance of the study was paramount, and I think we

  have to take that into account when we think of the

  issue of individual guilt.

            The other issue, question that I wanted to

  raise was that we began this afternoon with a

  discussion of the science before the ethics, so that we

  could understand the science before the ethics, and a

  question was the science good science or were elements

  of the science good science?

            In my field, neuroscience, we have experience

  with human experimentation done by the Nazis that led

  to potentially useful information about how our nervous

  system is organized anatomically but we do not use that

  information because it was obtained illegitimately.

            So my question to the group relates in part to

  that.  The ethical underpinnings of a scientific

  experiment are so paramount that is it perhaps even

  more effective to think of that before we even weigh

  the value of the science?

            DR. GUTMANN:  So, Steve, I'm going to call on

  Nita in a moment, but I would answer that an

  unequivocal yes.  I don't think that science can be

  understood as good science without an ethical

  underpinning to it and I think everybody around this

  table who is a scientist and a doctor does that and

  understands that as a given. And when we are confronted,

  as you so eloquently said, with somebody who sees

  science as divorced from the way human subjects or any

  animate beings are treated, divorced from that, it is

  shocking in a different way than the shock of somebody

  who is what we call in -- it's a technical as well as a

  colloquial term, a hypocrite, somebody who knows that

  he's doing wrong and does it anyway.

            The first is even more shocking.  We are more

  used to dealing with people who are hypocrites, who

  know that they're doing something wrong and for

  self-interested reasons do it than we are used to

  dealing with somebody who is doing something that, by

  all ordinary, correct ordinary standards is wrong but

  doesn't accept it because he thinks that what -- the

  purpose he is serving in science is so paramount that

  it trumps the basic ethical considerations.

            So I think what you brought out is very

  important for us to understand and it is and it ought

  to, it ought to intellectually as well as emotionally

  shock us.

            Nita.

            DR. FARAHANY:  Thank you, Amy.  I agree very

  much with your perspective on it and also with yours in

  that I think there's a difference between thinking that

  he was doing something unethical and recognizing that

  he was doing something wrongful.

            So I think he knew he was doing something at

  odds with social norms and he knew that he was doing

  something that was at odds with what the prevailing

  norms of the treatment of human research subjects were

  and he nevertheless thought that his values were more

  important than social values and social norms at the

  time and by ordinary standards of blameworthiness, it

  is appropriate for us to both weigh his value, right?

  I mean, there are defenses we have and mitigating

  circumstances we consider all the time, like is this

  such a mitigating circumstance, does it outweigh the

  existing prevailing norm, and I think we've done that

  in this report.

            I think we've looked to see what are the

  mitigating circumstances which are his claims.  Of

  course, they're vastly undercut by how poor the science

  itself was and by the methods that he used, but we can

  simply say he knew he was doing something wrongful,

  even if he believed that the ends justified the means,

  and that makes it a blameworthy action by deviating

  from what the norms were at the time which he

  recognized and intentionally flouted.

            DR. GUTMANN:  I just -- and then I'll call on

  Anita and go around.  I saw almost everybody's hand up.

  We have limited time.

            But let -- I think it's important to recognize

  here that when we talk about moral blameworthiness and

  wrong, we're not only -- and the report will make this

  clear -- talking about Dr. Cutler.  There were, alas,

  other doctors and scientists who knew and approved of

  this experiment and they're named in the report.  We're

  not trying to put fine gradations of blame here because

  there's no practical reason there.

            I think John Arras said it very well in that

  we want to avoid the assumption that everybody

  practicing at the time should have practiced at the

  highest standards that we now expect, not just

  recognize but expect today.  Nonetheless, there were

  other doctors, including, I'll just name one so there's

  another name out there, Dr. Mahoney, who knew and

  approved of these experiments.

            Anita.

            DR. ALLEN:  Well, I think Nita said everything

  so beautifully, I hardly have anything left to say, but I

  did want to make this point maybe to sort of follow up

  on Nita's point.

            I don't think that there's any mitigation or

  defense in the notion here that Dr. Cutler or his

  colleagues were well-intended or they were acting in

  accordance with what they felt was right, knowing they

  were going contrary to social norms, and that's because

  we also recognize as a moral failing arrogance and

  hubris and it is arrogant to the max to put your own

  values in front of social norms, especially when that

  involves a massive display of disrespect for 5,000

  other human beings whom you're inflicting with pain and

  suffering and diseases.

            So for that reason, I don't see any mitigation

  or any relief at all from the brand of immorality or

  unethical conduct or unethical character for these

  doctors.

 

This is a work of the U.S. Government and is not subject to copyright protection in the United States. Foreign copyrights may apply.