February 11, 2006

Case Western Reserve Profiles Insoo Hyun;
Hyun Claims AJOB Editors' View Him as "Guilty by Association"

The Observer newspaper of Case Western devotes its front page to a profile of bioethics faculty member Insoo Hyun.

[Update] Hyun's role in describing the social dynamics of the Korean situation, of late, has been noticeable, not only in his co-authored article in the pages of AJOB but in the media. He repeatedly made reports on "what happened" in Korea, commenting to The Chronicle that, "Hwang and Schatten were referring to each other as brothers." In Nature, Hyun is the sole source for descriptions of Hwang's relationship with Schatten:

Until recently, Hwang and Schatten had been getting on famously. "They seemed as close as they could be," says Hyun, who spent this summer studying the Korean team's ethical practices. "Gerry kept referring to Dr Hwang as his brother, and Dr Hwang's public toast to Gerry at a formal dinner was so effusive, it was almost embarrassing."
In USA Today, Hyun is the sole source commenting on the rigors of the egg donation protocols in Korea:
One irony of Hwang's resignation is that South Korea's egg donation standards, and those of Hwang's lab, are now stricter than U.S. standards, says bioethicist Insoo Hyun of Case Western Reserve University in Cleveland. The lab requires consent forms and psychological evaluations for donors.
In the Los Angeles Times, with obvious implications, Hyun described his dining experiences with Hwang: "If we would go to a restaurant, we'd get mobbed. He [Hwang] would joke to me, 'I'm like the Korean president or the Korean Elvis.'"

Imagine our surprise then to read Hyun's comments concerning the likely disposition of the Editors of AJOB concerning the retraction of the article by himself and Jung in AJOB to The Chronicle:

In conversations with Mr. McGee, Mr. Hyun says, he proposed publishing a modified version of the paper, one that outlines how to develop an ethical donation system. But Mr. Hyun says he was rebuffed. "I get the sense that there's guilt by association," he says.
The Chronicle prints the response of AJOB to the request:
Mr. McGee says he welcomes any new submission from Mr. Hyun. But the journal's editors decided that a modified version of the retracted paper did not warrant publication. "It does not make a substantive argument for the process it advocates, rather it reports on the mechanism that is purported, with the support of Dr. Hwang, to have been implemented," says Mr. McGee.
But there is no room in the Chronicle piece for a response from the Editors to Hyun's claim concerning a presumption of his guilt by association. At one level it is easy to respond - and the Editors will of course do so in the appropriate forum - that at no point and in no way was a claim made that Hyun was in any way involved in any misconduct or in particular involved with that of Hwang, in fact the retraction is quite clear on the matter: "Neither Dr. Hyun nor Dr. Jung have been accused of any misconduct with respect to the contents of this paper."

However, the question of guilt by association is really about something else - the question of whether AJOB in some way "imagined" that Hyun and Jung's reports were framed by the two authors in terms of their closeness to the Hwang group. It is a matter that must be addressed in full now that it appears so provocatively in the Chronicle And on this matter there isn't much question: the authors themselves claim not only proximity but the ability to sufficiently judge the implementation of a complex program for egg donation, writing:

These guidelines were closely followed in the Korean research protocol that resulted in the recent derivation of eleven patient-specific pluripotent stem cell lines (Hwang et. al 2005).
After discovering that their procedure was likely not followed, Hyun and Jung first requested that AJOB allow them to retract part of their paper, which the editors declined. The editors offered the possibility of an author-requested retraction of the entire article, or the publication of a letter in which the authors made comment on the events subsequent to the publication of their article. The editors cautioned the authors, however, that should any representations of fact concerning the authors' claims require further amendment, the journal would not publish a series of such corrections. The authors elected to write a letter to AJOB in which they would correct the record.

In the letter submitted, they offered no comments whatever on how the method they used to create and implement their policy might have failed, or more important on what specific representation they based their strong claim about the implementation.

In fact quite the contrary. The authors argued in the strongest possible language that despite the apparent deception, they were certain that the informed consent procedures were put into action in January of 2005. They assured the editors that there was unequivocal proof of this - and specifically that at least 10-15 donors had been put through the procedure - but could not produce that proof, they said, until certain records were unsealed.

The editors refused to publish such language, requiring that any letter include only the representation that, "The process we describe was not in place prior to January 23, 2005." The authors strongly objected to this requirement, several times indicating their certainty that the procedure was in fact followed and that author Jung had conducted several of the interviews for the process himself, but ultimately they acceded.

As we all now know, the procurement of eggs appears never to have been conducted according to the procedure described in the article in AJOB. The documentation that would have proven Hyun's second report of the facts - the modified claim that all donors after January 23rd were put through the procedure - did not in fact exist.

The Chronicle reports that "Mr. Hyun requested that the journal retract the paper, which Mr. McGee did late last month." This is utterly inaccurate. The Editors telephoned the authors to inform them that a retraction would be made by the journal, to which the authors agreed. However, even as the retraction was being authored - in careful consultation with Hyun - Hyun stated alongside that he could confirm based on yet another report - from an officer from the Health and Welfare Ministry - that at least six women in fact passed all three levels of the process and donated oocytes at Hanna Clinic, Hanyang University Hospital. This was the third report as to facts in South Korea. The question at this point was no longer whether or not the authors were deceived, but at what point it would begin to seem inappropriate to the authors to make strong representations as to what happened with their procedure on the basis of ad hoc interviews of those engaged either in the Hwang effort or in the investigation.

What Hyun describes as an implied guilt by association evidenced itself, he says, in AJOB's "rebuffing" a submission of the same paper without any claims as to what actually happened, but with the addition of an ethical argument for the paper. But as noted in the Chronicle piece, the editors actually said to Hyun that parsing their report in the paper concerning what had happened from an ethical argument not yet made but based on the same system just simply made no sense.

Why? Because any argument for a process of the kind reported in the Hyun and Jung article would obviously require something more dramatic than "beefing up the ethics": if the article were merely being modified, the authors would have to defend the claim that a procedure whose purpose was to protect women from unethical procurement of eggs, but that was totally and completely evaded even while observed by one or both authors - who were focused entirely on the process' purported operation - could in fact protect women from violations of ethics.

The claim that an intervention in bioethics has happened and is successful is one that can be verified using a number of methods ranging from interviews to participant observation to recorded interviews of consent sessions. With any such method, investigators can report and be judged on the validity of claims as to what did or did not happen, making clear the limits on their study. In the present case, proximity and observation were claimed as method, and no limits were articulated by the authors on either the method they used or on its deployment. So the report of the success of the method became a matter that peer reviewers and editors had to take on faith.

When the Editors pointed out to Hyun that a modified manuscript would have to explain th abject failure of the authors' methods for observing, interacting with and reporting the conduct of scientists, then defend a system whose only effect to date appears to have been to provide Hwang with the appearance of close collaboration with ethicists and ethics centers while he flagrantly defied their standard.

The effect of such a manuscript would be to throw open the door, we said, to the query: are the technique and the mode in which the process was developed an object lesson not in how to do good bioethics but in what happens when bioethicists are brought so close into the "inner circle" that they make, e.g., representations to the mass media concerning, e.g., the relationships among the principals. It is what Carl Elliot calls the question of the "lap dog."

The question of whether or not the experiment of putting these ethicists in this setting for this purpose was a success or failure seemed to us a question that should not be raised in the same manuscript that made an argument for a "best practice" for egg procurement.

Contrary to the report in the Chronicle, in a conversation with several of the editors, Hyun agreed with this point and said that the two would not submit another version of this manuscript. It was asked yet again whether AJOB might publish another reportorial piece by the authors, instead, in which the historical record would be cleared up on the basis of future investigation of the reports of the various investigative committees. AJOB discouraged such a submission for reasons that are all too obvious, but as reported in the Chronicle, at that point (and earlier, and later) the editors indicated to Hyun that if he wished he was welcome to submit an entirely different manuscript, although the other cautions remained.

The Chronicle piece is in fact riddled with relevant errors of this kind. They suggest for example that the authors came to the editors with a disclosure that they believed that eggs had been improperly procured. This happened, however, long before that time, in fact from the moment that Jung and Hyun's manuscript was submitted, the editors began asking questions about how the authors were able to ascertain several key claims about what had actually happened in the procurement of eggs. The manuscript was in fact delayed for some time while questions about these facts were discussed, and a commentary on the piece authored. The paper was in fact delayed so much that contrary to the claim in the Chronicle that the editor "rushed it into the January/February issue," the paper's review and revision required so much time that the authors expressed concern that the paper be moved along more quickly. That Hyun would report as damning that AJOB moved the paper to press quickly and released a press release on behalf of the paper is extraordinary.

The question of proximity and association is really quite simple. All around Hyun and Jung, who, the Chronicle reports "spent last summer on a Fulbright fellowship in South Korea studying the consent process that Dr. Hwang's team used to obtain eggs and adult cells for its research," and who have made themselves utterly available to the media to discuss the social dynamics of the Hwang lab, the Hwang team was engaged in deception that was massive and about which many if not most involved with egg procurement were aware. The deception also involved other sites obtaining eggs in ways that not only violated the Hyun/Jung standards but did so in a manifest way. Scientists in the lab disclosed their concerns about what would later prove to be violations of ethics in procurement, but not to the ethicists in the lab. The authors, working by their own report very intensively on site and claiming as the great advantage of their report their access to the lab, and at the invitation of Hwang, not only were unable to detect any abnormality prior to the creation of their process, nor later any failing in its implementation.

It is obvious that close association with the Hwang group was at best unhelpful for the authors in terms of describing a procedure that worked - or that could be demonstrated to prevent the sort of unethical behavior that it was designed to prevent. But worse the association clearly put the authors in the position described by the editors in the Chronicle piece as, at best, "duped" - and to the detriment of bioethics - not because of any misconduct by the authors, but because the authors - and by extension AJOB became the symbol Hwang would use to defray criticism that any impropriety had occurred. So the editors declined to publish a revision that treated the matter of how the procedure "worked" as distinct from its defensibility as a procedure for ethical procurement.

The solution? The Chronicle again provides a harsh attribution to Professor Hyun:

Mr. Hyun has had better luck with another bioethics journal, Hastings Center Report. Mr. Hyun had a paper in press with the journal when the scandal broke, and the editor decided to delay publication. Mr. Hyun is now revising the paper and expects it to come out in one of the next issues.
[Updated again...] Revision date 1:21AM EST Monday. Also c.f. Dr. Hyun's comments on this post.

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