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Michael Flaum, M.D., "Research Did Not Cause Stuttering"
Guest Opinion
The Daily Iowan
September 4, 2002, p. 8A


As someone involved with human-subjects research, I believe The Daily Iowan's reporting and editorials regarding the 1939 Tudor study disserve journalism, the university, and the Tudor study plaintiffs themselves. They simply perpetuate the mythology surrounding this master's thesis about the onset of stuttering.

The most decisive omitted fact is that the latest, impartial scientific evaluation of the study's data concludes that the researcher did not, indeed could not have, "caused stuttering" or done any other lasting harm for that matter. See for
example,

Ambrose and Yairi's article in the May 2002 Journal of Speech-Language Pathology
 
for the reasons.

The plaintiffs may, or may not, have suffered harm from something else before  they entered the Davenport home, while they were there, or thereafter. But there is, so far, no proof any harm they may have suffered in life was related to this research. Indeed, the cited study indicates there is evidence that it could not have been related.

The authors also conclude there is little or no indication the researcher had any intention to do harm.

That really ought to be the end of the matter. If harm was neither intended nor done, what's the problem? Where's the "lack of ethics" your editorial headlined?

There's more.

A former UI vice president for Research says the study "was well within the norms of the time." He's right. UI authorities approved not only this study but many others at the home. Those with legal responsibility for the orphans approved.

Even if harm was done and apparently it wasn't aren't "the norms of the time" the proper basis for moral judgment? Wouldn't you rather have your actions in 2002 judged by the standards of 2002 than by those of 2065?

But wait for the irony. In the late 1930s, there were no human-subjects ethical standards. And yet the standards self-imposed by this researcher and supervisor more than 60 years ago compare very favorably indeed with those of major
research institutions today.

They certainly compare favorably with the Tuskegee syphilis study, subjects exposed to atom bomb radiation, the 12,000 babies with thalidomide birth defects, or subjects deliberately injected with cancer and hepatitis. Such studies were approved by government and prestigious institutions decades after the 1939 study.

Now, there are very detailed ethical standards. And yet, within the past two or three years, the NIH has shut down eight major institutions for violations. In 1999, the FDA chastised the UI itself for "corrections promised but not implemented" in
1992, 1995, and 1998. In 2001, a volunteer subject in a research study at Johns Hopkins actually died.

There are many intricate issues surrounding the role of clinical trials and other uses of human subjects in research. Among those issues are the most appropriate legal and ethical standards (including those that unnecessarily inhibit needed research). That would be a worthy subject for The Daily Iowan's editorial treatment.

Picking on a dusty master's thesis from 1939, and repeating the myth that it did harm in unethical ways when it did not, is not only grossly unfair to the researcher and misleading to the public, it's also a rather bizarre choice of "news peg" from among the hundreds of timely and significant case studies available for editorial treatment.
 

Michael Flaum, M.D., director,
Iowa Consortium for Mental Health