McMaster-affiliated researcher broke embargo to leak hydroxychloroquine study to Trump administration: BMJ
EDMONTON -- A former assistant professor and researcher at McMaster University leaked an embargoed report of potential COVID-19 treatments to the Trump administration, suggesting that it lent support to the use of the antimalarial drug hydroxychloroquine, according to the British Medical Journal (BMJ).
Documents released in a U.S. congressional investigation show that Paul Alexander, who served as assistant secretary for public affairs at the U.S. Department of Health and Human Services, shared a preprinted version of the research via email to the commissioner of the Food and Drug Administration (FDA) in July.
The FDA issued an emergency authorization for the anti-inflammatory drug last April, one that Trump touted as a favoured treatment for COVID-19 in the early stages of the pandemic.
Trump claimed to have taken a two-week course of the drug to protect against COVID-19, despite his own officials cautioning that the drug should not be used outside of hospital or research settings due to potentially fatal side effects.
The FDA later revoked its authorization in June, citing the drug’s “known risks,” stating that it was “no longer reasonable to believe” that it was effective in fighting COVID-19.
A month later, on July 19, 2020, Alexander sent an email addressed to FDA commissioner Stephen Hahn, deputy commissioner Anand Shah, and health department press chief Michael Caputo, who had recently appointed Alexander as his scientific advisor, with the embargoed report.
“I weighed the balance and this is so important and such an emergency and while I have not done this before and will not again, I share this embargoed so that you are primed of what we found if it could help your decision making to help the USA and the globe as the U.S. leads the globe, rightly,” he wrote in the email, provided as evidence to the U.S. House Select Subcommittee on the coronavirus crisis.
In his email, Alexander highlights specifics of the report that appeared to suggest a reduction in symptom duration in patients taking hydroxychloroquine. However, the finding is described as “low certainty.”
“We found that in patients who received Remdesivir... hydroxychloroquine.... and Lopinavir-Ritonavir… had a shorter symptom duration than standard care. For hydroxy there was no other benefit and there was apparent risk of adverse events,” read the highlighted section of the email.
Neither the final published analysis, which was published by the British Medical Journal (BMJ) on July 30, 2020, nor the version Alexander leaked to the FDA suggested that hydroxychloroquine was an effective treatment for COVID-19.
Preprinted reports are often provided before researchers submit their material for publication to ask colleagues and peers for comments on the completed work, otherwise known as an informal peer-review process. As the BMJ explains, these works are under embargo "to ensure that health information reaches the public domain in a responsible manner."
Alexander did not respond to a request for an interview from CTVNews.ca.
A McMaster spokesperson told CTVNews.ca Thursday that Alexander is not teaching at McMaster and has "no paid role" at the university.
"He does not speak or act on behalf of the university," the emailed statement read.
Alexander is still listed as a part-time assistant professor in the Hamilton-based university's Department of Health Research Methods, Evidence and Impact on the university’s website.
His publications listed on the website include an article titled "COVID-19 coronavirus research has overall low methodology quality thus far: case in point for chloroquine/hydroxychloroquine," published in the Journal of Clinical Epidemiology, which concludes that “the COVID-19 research methodology is very poor in the area of chloroquine/hydroxychloroquine research.”
Study author Reed Siemieniuk, methodologist and physician at McMaster University, told the BMJ that Alexander contributed “very early on to the first iteration” of the report as part of a team screening titles and abstracts.
“Paul stepped off of the research group prior to contributing to additional updates, when at the same time he notified us that he had taken a position working for the U.S. government,” he said, according to the BMJ.
Siemieniuk added that he was not aware Alexander had broken the embargo.
Alexander is mentioned in the acknowledgements of the now published report.
“We thank Paul Alexander (who was an author in the previous version of this review) for input and early contributions,” it reads.
As the BMJ points out, there was no change in the FDA’s position on hydroxychloroquine after receiving the leaked report.
In October, the U.S. National Institutes of Health recommended against using the drug in hospitalized COVID-19 patients. This week, the World Health Organization (WHO) said the drug shouldn’t be used as a preventative measure.
Alexander appears to reference his new role in Washington as a reason for receiving pushback from the other authors of the report, which was supported by the Canadian Institutes of Health Research.
“You would know the one reason why I stand out among this group of some [of] the world’s top researchers which I am proud of and made the personal decision to reveal it,” reads the email cited by the subcommittee.
“I was told that had I not played such a prominent role in this project [starting] in Feb. before I came on deck, that they would not have wanted me in it and I expected this since coming to D.C. and experiencing the pushback, which is so terrible.”
The same congressional investigation put Alexander in the hot seat for allegedly trying to prevent Anthony Fauci, the U.S. government’s top infectious disease expert, from speaking about the risks that COVID-19 poses to children.
Previous emails obtained by Politico, published in September 2020, allegedly showed Alexander instructing press officers about what Fauci should say during media interviews.
“Can you ensure Dr. Fauci indicates masks are for the teachers in schools. Not for children,” Alexander wrote in one email, according to Politico.
“There is no data, none, zero, across the entire world, that shows children especially young children, spread this virus to other children, or to adults or to their teachers. None. And if it did occur, the risk is essentially zero."
The U.S. Centers for Disease Control and Prevention's (CDC) guidance regarding COVID-19 and children, last updated in December 2020, notes that while fewer children have been sick with the disease compared to adults, children can be infected, get sick from COVID-19, and can spread the virus to others. According to the CDC's latest data, released in September, more than 277,00 COVID-19 cases have been reported in U.S. children.