Monday, August 17, 2020

Next up on the Trump Snake Oil menu

To the alarm of some government health officials, President Trump has expressed enthusiasm for the Food and Drug Administration to permit an extract from the oleander plant to be marketed as a dietary supplement or, alternatively, approved as a drug to cure COVID-19, despite lack of proof that it works.

  Axios
A dietary supplement or a virus cure. 
The experimental botanical extract, oleandrin, was promoted to Trump during an Oval Office meeting in July. It's embraced by Housing and Urban Development Secretary Ben Carson and MyPillow founder and CEO Mike Lindell, a big Trump backer, who recently took a financial stake in the company that develops the product.

[...]

Lindell, who is a major advertiser on Fox News and a personal friend of Carson and Trump, helped Whitney get an Oval Office meeting with the president in July to discuss oleandrin as a potential COVID-19 cure.

[...]

[Andrew Whitney of Phoenix Biotechnology] has claimed to administration officials that oleandrin cures COVID-19 in two days, according to a source familiar with his private comments.

[...]

"Now, there are all sorts of lawyers who would tell me I can't say things like that, because you know you need to have years of studies, and you need to have this, that, and the other, and so forth," Whitney said. "But as an American with a right of free expression, I'm telling you, I've seen it with my own eyes."

[...]

Asked what human clinical evidence he has provided to the FDA to support his claim that oleandrin cures COVID-19, Whitney did not provide any additional evidence, saying, "At this stage it's probably best left at that. The data is compelling."
I'm just sadly shaking my head.
It's part of a pattern in which entrepreneurs, often without rigorous vetting, push unproven products to Trump — knowing their sales pitches might catch his eye. Trump will then urge FDA Commissioner Stephen Hahn to "look at" or speed up approval.

[...]

There is no public data showing oleandrin has ever been tested in animals or humans for its efficacy against COVID-19, but the extract has shown some evidence of inhibiting the virus in a non-peer reviewed laboratory study.
Good enough for neurosurgeon Ben Carson. And the My Pillow guy.
Lindell said that he, Carson, at least one lawyer and, briefly, White House Chief of Staff Mark Meadows, joined Trump and Whitney for the meeting. Notably absent was Hahn, the head of the agency that studies and approves medical treatments.

[...]

The first path is as a COVID-19 drug, which would involve a rigorous process that includes clinical trials.

But to hedge his bets, Whitney said he is also pushing the FDA to allow oleandrin to be sold off the shelf as a dietary supplement — a move that could be made immediately, Whitney has told administration officials.

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Professor Sharon Lewin, the director of the Peter Doherty Institute for Infection and Immunity at the University of Melbourne, is an international authority on antiviral drugs and has a laboratory working on COVID-19.

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"Oleandrin looks to have antiviral activity at high doses in a test tube model. You'd certainly want to see more work done on this before even contemplating a human trial."

[...]

Caree Vander Linden, a spokesperson for the United States Army Medical Research Institute of Infectious Diseases, emailed the following statement to Axios: "In May 2020, USAMRIID performed some preliminary testing of oleandrin against SARS-CoV-2 [the virus that causes COVID-19]. Our results were inconclusive."

"Additionally, USAMRIID was contacted by University of Texas Medical Branch at Galveston, indicating that they were also testing it," Vander Linden added. "Given our inconclusive results, and having other high priority therapeutics to assess, we did not continue with this line of research."

[...]

A July 2020 study from the University of Texas at Galveston shows, in a laboratory setting, that oleandrin can inhibit the coronavirus in monkey kidney cells. This study has not been peer reviewed and one of the authors of the study, Robert Newman, is chairman of Phoenix Biotechnology's scientific advisory board — the company developing the oleandrin product.

[...]

When Axios checked the website on Friday night, Newman was still listed as president. But on Saturday evening, after Axios had emailed questions to Whitney, Newman was no longer listed as president of the company; the website listed him only as a scientific adviser.

Asked why the company made this change on Saturday, Whitney texted, "He recently stepped down as president to focus purely on science. This is a small company that has relatively few personnel and is going through acceleration and reorganization."

[...]

Told about the alarm inside the administration regarding his promotion of oleandrin, Lindell said, "This is the most amazing miracle thing I've ever seen in my life, so I went all in.... If you want to know what I think, I think it's being suppressed because somebody doesn't want this out there because it works."
Tell it to QAnon.

...but hey, do what you want...you will anyway.

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