A former graduate student at Wake Forest School of Medicine “presented falsified and/or fabricated data” in a government-funded drug study, according to findings released by the U.S. Office of Research Integrity earlier today.
The report was released in the wake of an investigation conducted by the university and the ORI. Investigators found that although Brandi Blaylock recorded responses of a dozen laboratory monkeys after giving them anti-abuse drugs, she hadn’t given them the compounds “per protocol.”
Blaylock then presented the data at “two poster presentations, several laboratory meetings, and progress reports.”
Some of her research was supported by a grant from the National Institute of Drug Abuse, “Dopamine D2 Receptors In Primate Models of Cocaine Abuse,” which examined the effects of novel dopamine D3 receptor compounds on drug addiction on monkeys.
However, according to the report, Blaylock presented the falsified responses from a dozen monkeys:
Specifically, ORI found that the respondent knowingly presented falsified and/or fabricated data indicating that twelve non-human primates (either rhesus or cynomolgus monkeys) responded to anti-abuse nicotinic acetylcholine and/or dopamine receptor selective compounds in self-selectivity assays for cocaine, methamphetamines, or nicotine when the compounds were never given to the monkeys per protocol.
The data were then presented in meetings and reports:
ORI found that respondent engaged in research misconduct by falsifying and/or fabricating data reported in two poster presentations, several laboratory meetings, and progress reports associated with NIDA, NIH, grant R01 DA012460.
A source close to the investigation told us that they were unable to find the original data from the experiments, and so assumed Blaylock had never performed them.
Blaylock has entered into a voluntary settlement agreement with the ORI and agreed to three years of supervision and data validation if she engages in U.S. Public Health Service supported research.
According to the ORI report, she has not engaged in government-funded research in the last three years and “stated that she has no intention of engaging in PHS-supported research in the future.”
Blaylock won an award in 2011 from the ORI for travel expenses to the Quest for Excellence in Research conference in Washington D.C.
In a video posted to Youtube, a woman who identifies herself as Blaylock talks about her research education, and the important role her professors have played in her life.
Blaylock now teaches science at the Summit School in Winston-Salem, North Carolina.
When reached by email, Blaylock said:
I have no comment and please do not contact me again
She also would not confirm whether that is her YouTube video.
A spokesperson for Wake Forest Baptist Medical Center — of which Wake Forest School of Medicine is a part — told us they had nothing to add to the report.
We’ve reached out to the grant’s principal investigator, Michael Nader. We’ll update with any response.
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This is a little hard to understand. If she did not give the drugs “per protocol”, does that mean she did not give them at all, or that she made errors in the administration of said drugs? The two are not equivalent.
The maxim is “never ascribe to malice what can be explained by incompetence”. Is this such a case? Is there evidence that she KNEW how to administer the meds, and did not, or is it simply that the medications were not administered correctly?
From the phrase “so assumed Blaylock had never performed them” (the experiments), I have (very) tentatively concluded that the phrase “per protocol” refers to the protocol of the entire experiment (and might, therefore, have been accurately and more clearly rewritten as “per the experimental protocol”): that is, I think that the intended meaning is that “the experimental protocol called for the drugs to be administered, and they were not administered”, rather than that “the experimental protocol included a drug administration sub-protocol, and drugs were administered in a way that did not follow that sub-protocol”.
I don’t know if my conclusion is consistent with standard usage in the field.
I am a clinical trialist and statistician. In my experience, “per protocol” means “as specified in the protocol”. For instance, if the protocol called for an injection, and the drug was given by mouth, that would be considered “not per protocol”. So, I reiterate, incompetence or malice?
The key I think here is “knowingly”. If she knew that her data were not collected according to protocol (either because she did not follow the experimental protocol or more likely, she did not do the experiments at all), she was fully aware that her data were at best misrepresented or more likely fabricated. As Lee said, the statement about the missing data makes it pretty obvious although that is not stated in the ORI report. I highly doubt this is a question about not knowing how to deliver the drugs. These are experiments involving non-human primates that come with a lot of animal welfare oversight and leave very little wiggle room about how and when drugs are being administrated.
Paul, if you found it hard to understand, then it has worked.
Phrases like “protocol not been followed exactly” are excellent euphemisms that benefit all involved entities, if a study is fake. The institution can argue, truthfully, that it has made an accurate statement. Even if more information comes out later, it can point to its statement being correct.
The person involved, on the other hand, can tell friends and relatives that it was a minor error – a mistimed dosing here, a wrong weight adjustment there – and that they were dealt with harshly but fairly by the investigation which was obliged to stick to the letter of the regulations. Friends and relatives are relieved because they can continue to be supportive as human beings. Everyone can move on with their lives.
Everyone is happy. As long as the bargain is maintained wherein neither the institution nor the individual ever gives out any more information.
Maybe this inference is incorrect? We will know because, if there is no secret deal for silence, the institution or the individual would surely publicly state exactly what happened. Unless the reality is worse than the speculation.