A guest article by Dr. Robert Baratz.

(Black Box warnings are text put on drug labels inside a black box to alert clinicians and consumers of serious adverse reactions.)

In response to criticism about her involvement with “Malariotherapy,” Victoria Wells Wulsin, MD has claimed that she was only doing a literature review for Henry Heimlich and the Heimlich Institute.

Wulsin shares any “ethical violations perpetrated by the Heimlich Institute” related to the East African data reviewed in her report because of the U.S. Common Rule at 45 CFR 46, with which Wulsin is no doubt familiar from her employment with the CDC.  Other other widely recognized statements of ethical principles require prior IRB review and approval for the use, collection, or dissemination of *identifiable private information* collected about living human beings in the course of an “interaction” not otherwise exempt. Her activities in reviewing these data do not meet any of the exemptions at 45 CFR 46.101 (b):

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

In particular her activities do not meet the exemption for use of “existing data” because the data are neither public nor de-identified, whether permanently or by a key held by a third party. We can be certain the data were not de-identified because Wulsin does not say they were.

Moreover, Wulsin admits she was unable to ascertain that there was ethical review and approval of this study or that subjects gave informed consent. In fact no IRB would ever approve a trial which delayed treatment of subjects infected with falciparum malaria.  Note here that the identity of the strain of malaria is something Wulsin was “unclear” about. In just the same way as researchers do not use data gathered by Nazi researchers in the course of unethical research, so too Wulsin is constrained from reviewing and causing to be further disseminated the data from East Africa. Put differently, she had an affirmative obligation to refuse to review or otherwise use these data.

Let’s face it, Wulsin made a terrible mistake in judgment, first to get involved with the Heimlich Institute at all, and second, to assist in the attempt to lessen the well-deserved stigma of malariotherapy by lending her skill and reputation to it by compiling the report.

In response to questions and justifiable outrage, instead of honest contrition, Wulsin attempts to minimize her actions and defends herself with the very same inane arguments put forth by Dr Heimlich many years ago when he was criticized severely for these outrageous experiments by the same CDC for which Wulsin previously worked. These arguments were false then and are equally false now.  They severely diminish Wulsin’s reputation as a physician.

If scrutiny and criticism bother her, Wulsin shouldn’t have invited it by running for political office.

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