South Dakota Abandons Hydroxychloroquine Trial After Faster Minnesota Study Finds Trump Pills Don’t Help

Why did South Dakota pull the plug on Governor Kristi Noem’s vaunted statewide clinical trial of Trump Wonder Pills™? Because Minnesota did the science faster and better and found we were wasting our time:

The University of Minnesota this week published the results of its study in the New England Journal of Medicine. It is one of the nation’s first randomized trials with the drug. The study, which had a similar design to the planned South Dakota trial, found no benefit of hydroxychloroquine over a placebo as a post-exposure preventive therapy.

The South Dakota trial was in the early stages and had just recently opened for enrollment.

“After closely reviewing the new research, our clinical trial team determined that the South Dakota study is unlikely to see different results,” said Susan Hoover, M.D., Ph.D., Sanford Health infectious disease doctor and principal investigator of the study. “We’re focused on our goal of advancing the science around this disease and will continue to pursue other COVID-19 research” [link added; Shawn Neisteadt, “SD Hydroxychloroquine Trial Discontinued After New Evidence,” Sanford Health, 2020.06.05].

Kristi Noem bragged to Fox News from her private vanity studio in April that her HCQ trial was all about going on “offense” against coronavirus. But her private health care providers were struggling to get a team suited up in May. But the University of Minnesota, a public institution, had its team on the field and was doing this science in March:

The trial results, which were published in the New England Journal of Medicine, determined that hydroxychloroquine was not able to prevent the development of COVID-19 any better than a placebo. Further, 40% of trial participants taking hydroxychloroquine developed non-serious side effects — predominantly nausea, upset stomach or diarrhea. However, the trial found no serious side effects or cardiac complications from taking hydroxychloroquine.

The randomized placebo-controlled trial, which rapidly launched on March 17, tested if hydroxychloroquine could prevent COVID-19 infection in healthy persons after exposure to someone with COVID-19. The trial enrolled 821 non-hospitalized adults from across the U.S. and Canada, who were exposed to COVID-19 from someone living in their same household or as a healthcare worker or first responder. Half of the participants received five days of hydroxychloroquine while the other half received five days of a placebo. The trial was a double-blind trial, meaning that neither the participants nor the researchers knew what the participants received. Participants were followed for two weeks to see who developed symptomatic COVID-19.

Overall, approximately 12% of those given hydroxychloroquine developed COVID-19 versus approximately 14% given the vitamin placebo (folate). This was not a statistical difference, and even if there was a statistical difference, this would equate to treating 42 persons with hydroxychloroquine in order to prevent one infection. There was no further benefit to prevent infection among those who also took zinc or vitamin C [“Post-Exposure Prophylaxis or Preemptive Treatment for Coronavirus: University of Minnesota Trial Shows Hydroxychloroquine Has No Benefit over Placebo in Preventing COVID-19,” University of Minnesota, 2020.06.03].

Governor Noem received 1.2 million doses of hydroxychloroquine in April for her now aborted science project. At the time, she claimed that shipment was a product of her unique relationship with the federal government, even though South Dakota’s haul was just a small fraction of the 30-million-pill stockpile that the feds got from the Swiss pharmaceutical maker Novartis and handed out to all sorts of cities and states.

Health Secretary Kim Malsam-Rysdon says Sanford will keep handing out HCQ to covid-19 patients who ask for it. But maybe we ought to knock that off and save that stockpile in case the mosquitoes get bad and malaria surges, or to help people with arthritis and lupus—you know, the diseases science says HCQ actually works on.

Related Rereading: Minnesota eclipsed South Dakota’s struggling HCQ trial at the same time that The Lancet retracted a May 22 article in which indicated higher rates of heart trouble and fatality from HCQ. That article prompted the World Health Organization to pause its global HCQ trial. After scientists raised concerns about the methodology of the study, The Lancet asked Surgisphere, the private corporation that conducted the study, to share its data for review. Surgisphere declined:

After publication of our Lancet Article, several concerns were raised with respect to the veracity of the data and analyses conducted by Surgisphere Corporation and its founder and our co-author, Sapan Desai, in our publication. We launched an independent third-party peer review of Surgisphere with the consent of Sapan Desai to evaluate the origination of the database elements, to confirm the completeness of the database, and to replicate the analyses presented in the paper.

Our independent peer reviewers informed us that Surgisphere would not transfer the full dataset, client contracts, and the full ISO audit report to their servers for analysis as such transfer would violate client agreements and confidentiality requirements. As such, our reviewers were not able to conduct an independent and private peer review and therefore notified us of their withdrawal from the peer-review process.

We always aspire to perform our research in accordance with the highest ethical and professional guidelines. We can never forget the responsibility we have as researchers to scrupulously ensure that we rely on data sources that adhere to our high standards. Based on this development, we can no longer vouch for the veracity of the primary data sources. Due to this unfortunate development, the authors request that the paper be retracted [Mandeep R. Mehra, Frank Ruschitzka, and Amit N. Patel, “Retraction—Hydroxychloroquine or Chloroquine with or without a Macrolide for Treatment of COVID-19: A Multinational Registry Analysis,” The Lancet, 2020.06.05].

The World Health Organization is resuming its seventeen-nation “Solidarity” trial of hydroxychloroquine… with or without the assistance of the United States of America.