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Could Bad Actors Manipulate a Drug Trial?

Anthony Fauci is touting the “randomized placebo-controlled clinical trial (RCT)” as the “gold standard” and the reason he denounces other evidence-based studies about COVID-19.

That mentality has been used by the Biden administration to discredit studies showing the effectiveness of existing drugs, like hydroxychloroquine, in preventing serious illness and death from COVID-19.

But today, when technology allows bad actors to fake anything, from news articles to video, could the esteemed RCT be subjected to tampering as well?  Last year, the world’s two leading medical journals, The Lancet and The New England Journal of Medicine, pulled articles on studies when researchers were caught using flawed data to denounce hydroxychloroquine (HCQ) as a treatment for COVID-19.

The idea that data in an RCT can be “hijacked” by bad actors is not so far-fetched, writes Eric Sass, the editor-in-chief of The Economic Standard. Sass points out that “hijacking” can happen during online recruitment for study participants. Researchers acknowledge that volunteers could certainly fake symptoms in an effort to hoard the real drug, but they are unlikely to do so because they may end up getting the placebo.

Sass says that reasoning points to a fatal flaw.

“While the study design may or may not have served to deter hoarders or other self-interested individuals, this does not account for the possibility of intervention by a group or organization determined to portray HCQ as ineffective,” Sass writes.

How to Rig a Trial

Sass describes how such a scenario could occur.

“Upon receiving the drug of unknown identity in the mail, a sophisticated group could test it to determine whether it contained HCQ or placebo,” Sass writes.

“Such an entity could perform such tests with relative ease using a spectrophotometer, an instrument widely used in the health profession and educational environment,” Sass writes. “Once the traits of the drug were identified for one purported enrollee, more rudimentary means (e.g., appearance) might be used to allow other individuals to determine whether a drug was HCQ or placebo.

“If the drug were found to be the placebo, the (fake) enrollees would submit symptom data which reflected rapid recovery,” Sass writes. “If the drug contained HCQ, they would report slow resolution of symptoms. Of note, at no point did any participant need to communicate with, or be seen by, a doctor, nor did they have to actually take the medication.

The idea that an individual would go to such trouble to discredit a drug sounds far-fetched, but Sass counters that notion.

“A motivated and sophisticated entity could have manipulated data in both arms to show HCQ to be ineffective and the placebo to be highly effective,” Sass writes. “An essential point is that such a manipulation might have occurred without the authors’ knowledge.”

Sass writes it would take only a few patients to manipulate the study results.

“While it might seem beyond our comprehension that any ‘motivated entity’ would ‘hijack’ a scientific study with life-or-death implications for thousands of people, the retracted articles in the Lancet and NEJM suggest that there may be more at work than meets the eye,” Sass writes.

 

AnneMarie Schieber (amschiebe@heartland.org) is the managing editor of Health Care News.

 

 

AnneMarie Schieber
AnneMarie Schieber is a research fellow at The Heartland Institute and managing editor of Health Care News, Heartland's monthly newspaper for health care reform.

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