Shame and Guilt in Clinical Trials

Carl Elliott is a Hastings Center Fellow and a professor at the Center for Bioethics at the University of Minnesota. His
most recent book is White Coat, Black Hat: Adventures on the Dark Side of
Medicine.

This post originally appeared at the Hastings Center's Bioethics Forum.

Over the past month, a petition asking the governor of
Minnesota to investigate a research scandal at the University of Minnesota has
been steadily gathering momentum. The scandal in question originated in 2004
with the suicide of Dan Markingson in an AstraZeneca-funded study of
antipsychotics. The petition to investigate the scandal is backed by a number
of high-profile supporters, among them Lancet editor Richard Horton,
former BMJ editor Richard Smith, three former editors of the New
England Journal of Medicine (Marcia Angell, Arnold Relman, and Jerome
Kassirer), Wellesley College historian Susan Reverby, who uncovered the
Guatemala syphilis studies, Hastings Center co-founder Daniel Callahan, and
over 200 scholars in bioethics, clinical research,
medical humanities, and related disciplines.

The petition also has a noticeable gap. Very few signers come from
the University of Minnesota. In fact, only two people from the Center for
Bioethics have signed: Leigh Turner and me. This is not because any faculty
member outside the Department of Psychiatry actually defends the ethics of the
study, at least as far as I can tell. What seems to bother people here is
speaking out about it. Very few faculty members are willing to register their
objections publicly.

Why not? Well, there are the obvious possibilities—fear, apathy,
self-interest, and so on. At least one person has told me she is unwilling to
sign because she doesn’t think the petition will succeed. But there may be a
more interesting explanation that I’d like to explore. For those who are
unfamiliar with the scandal, however, let me backtrack briefly and explain the
events in question. (You can read the longer version in Mother Jones magazine
and additional background in a Bioethics Forum post.)

In late 2003, Dr. Stephen Olson, the head of the schizophrenia
program at the University of Minnesota, recruited an acutely psychotic young
man named Dan Markingson into an AstraZeneca-funded research study of
antipsychotic drugs. Olson enrolled Dan despite the fact that he had been
repeatedly judged incapable of giving informed consent, despite the fact that
his mother objected to his participation, and despite the fact that Dan had
been placed under an involuntary commitment order that legally compelled him to
obey Olson’s recommendations. For months, Mary Weiss, Dan’s mother, tried
desperately to get her son out of the study, warning that his condition was
worsening and that he was in danger of committing suicide. Her warnings were
ignored. In May 2004 Dan stabbed himself to death with a box cutter so violently
that he nearly decapitated himself.

The research study itself was plagued by ethical problems: financial
incentives to keep subjects in the study as long as possible, conflicts of
interest for the investigators, an inexplicable gap in the exclusion criteria,
and a questionable scientific rationale. AstraZeneca was eventually forced to
pay $520 million in fraud penalties, and some of its misconduct was traced back to the University of Minnesota.

You might think that events this alarming would prompt a
university investigation. That is not what happened. Instead, the university blocked Mary’s efforts to get Dan’s medical
records, and when her lawsuit against the university was dismissed on grounds
of sovereign immunity, it filed a legal action against her, demanding $57,000
in legal costs. Even as evidence has accumulated suggesting a much larger
problem involving more psychiatric studies and more mistreated
subjects, the university has stonewalled every effort to get to the truth.

Why would faculty members remain silent about such an alarming
sequence of events? One possible reason is simply because they do not feel as
if the wrongdoing has anything to do with them. The University of Minnesota is
a vast institution; the scandal took place in a single department; if anyone is
to be blamed, it is the psychiatrists and the university administrators, not
them. Simply being a faculty member at the university does not implicate them
in the wrongdoing or give them any special obligation to fix it. In a phrase:
no guilt, hence no responsibility.

My view is somewhat different. These events have made me deeply
ashamed to be a part of the University of Minnesota, in the same way that I
feel ashamed to be a Southerner when I see video clips of Strom Thurmond’s
race-baiting speeches or photos of Alabama police dogs snapping at black civil
rights marchers. I think that what our psychiatrists did to Dan Markingson was
wrong in the deepest sense. It was exploitative, cruel, and corrupt. Almost as
disgraceful are the actions university officials have taken to cover it up and
protect the reputation of the university. The shame I feel comes from the fact
that I have worked at the University of Minnesota for 15 years. I have even
been a member of the IRB. For better or worse, my identity is bound up with the
institution.

These two different reactions—shame versus guilt—differ in important
ways. Shame is linked with honor; it is about losing the respect of others, and
by virtue of that, losing your self-respect. And honor often involves
collective identity. While we don’t usually feel guilty about the actions of
other people, we often do feel ashamed if those actions reflect on our own
identities. So, for example, you can feel ashamed at the actions of your
parents, your fellow Lutherans, or your physician colleagues—even if you feel
as if it would be unfair for anyone to blame you personally for their actions.

Shame, unlike guilt, involves the imagined gaze of other people.
As Ruth Benedict writes: "Shame is a reaction to other people’s criticism.
A man is shamed either by being openly ridiculed or by fantasying to himself
that he has been made ridiculous. In either case it is a potent sanction. But
it requires an audience or at least a man’s fantasy of an audience. Guilt does
not.”

In scandals, this imagined audience can produce very different,
even opposite, reactions. On the one hand, it is what leads many people to try
so hard to keep scandals secret. This impulse to cover up wrongdoing can be
toxic, as the Catholic Church has discovered. But it is also what leads
insiders to speak out publicly against a scandal. By speaking out, you show
that you are separating yourself from the wrongdoing in order to maintain your
honor and self-respect. You are saying to the world, “Do not think that I am a
part of this.”

Shame and honor may seem like old-fashioned ideas, but if you read
the comments left on the petition by University of Minnesota alumni, you cannot
help but be struck by their language. “How shameful for UMN, my alma mater.” “I
am a graduate of the University of Minnesota and want to be proud of my school,
but following this case has made me deeply ashamed.” “I am a University of
Minnesota alum, and I am ashamed of my alma mater right now.” “To call this
merely shameful would be wholly inadequate.” “Attended U of MN Medical School
and then U of MN Psychiatry residency – ashamed of the Psychiatry Department.” “I
am a graduate (CLA, 1981) and ashamed of the way the University continues to
handle this tragic case.” “The University's legal team should also be ashamed
of their behavior in further victimizing this family.”

Obviously, this shame is something I understand, or else I would
not be working so hard to raise awareness of the petition and convince others
to sign on. (You can sign the petition here.) I also believe that the
truth will eventually come out, and when that happens, there will be more than
enough shame to go around. The refusal to investigate will only make things
worse. As Jesse Ballenger writes on the petition, “As a faculty member at a
university (Penn State) now notorious for failing to investigate abuses, I find
the refusal of the University of Minnesota to confront this scandal sadly
familiar.”

Editor’s Note: Beacon Broadside’s editor, Jessie Bennett, is
one of the University of Minnesota alumni quoted above.

Read an Excerpt or the Reader's Guide from White Coat, Black Hat.