For example, I am proud of having been part of a team that was the first ever to report that the dietary supplement L-tryptophan can via the eosinophilia-myalgia syndrome. This important conclusion - which had major public health policy implications - was based on a single reported case of pulmonary hypertension. In other words, it was based on a single "anecdote." Had we dismissed this finding because a single anecdote is not data, then we would have failed to report this relationship and many more patients would have suffered that fate, possibly leading to fatalities.

The rest of the story is that despite the Common Rule and the intense efforts to try to prevent human subject violations in research, there are still occasional studies which find their way through the cracks. This is one bad example. It is an example of an unethical experiment that should never have been approved by an IRB in its current form because it blatantly violates the ethical principles of both consent and informed consent.

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