To the alarm of some government health officials, President Trump has expressed enthusiasm for the Food and Drug Administration to approve an extract from the oleander plant as a dietary supplement to cure COVID-19, despite lack of proof that it works.
- 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 told Axios that in the meeting, Trump "basically said: …'The FDA should be approving it.'"
- The White House did not respond to requests for comment.
Why it matters: A senior administration official familiar with the internal conversations told Axios, "The involvement of the Secretary of HUD and MyPillow.com in pushing a dubious product at the highest levels should give Americans no comfort at night about their health and safety during a raging pandemic."
The big picture: 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.
- In March, Trump personally lobbied Hahn to authorize hydroxychloroquine's emergency use to treat COVID-19.
- The FDA obliged. But in June, after a large trial, the agency revoked that authorization and warned of the "risk of heart rhythm problems" in COVID-19 patients treated with the drug.
Behind the scenes: Senior administration officials familiar with the internal conversations around oleandrin have raised concerns about the way this botanical extract — pushed by Andrew Whitney of Phoenix Biotechnology — is being promoted at the highest levels of the Trump administration.
- 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.
- In an interview on Saturday, Whitney told Axios that oleandrin has been tested on humans for its efficacy against COVID-19 but said the study has not been published yet. He also said the lab study is in the process of being peer reviewed.
HUD Secretary Carson has enthusiastically promoted oleandrin to Trump administration officials and to the president himself.
- MyPillow CEO 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. (The Washington Post first reported this meeting.)
- 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.
- Asked why the HUD secretary was promoting an unproven botanical extract to cure COVID-19, a Carson spokesperson emailed the following statement to Axios: "Secretary Carson is a member of the Coronavirus Task Force, he has been directly involved with the Administration's response to this disease from the very beginning."
- "The Task Force is looking at a plethora of therapeutics to fight COVID-19," the statement also said. "To suggest that Secretary Carson, who is a world-renowned expert in the medical field, shouldn't be involved is not only absurd but unhelpful in our collective fight to eradicate the pandemic."
- A senior official familiar with Carson's involvement noted that while Carson is a world-renowned expert in pediatric neurosurgery, he is not a world-renowned expert on antiviral drugs or infectious diseases.
What's next: Whitney said he is pursuing multiple paths to getting oleandrin to market.
- 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.
Whitney has claimed to administration officials that oleandrin cures COVID-19 in two days, according to a source familiar with his private comments.
- But if the FDA allows oleandrin to be sold as a dietary supplement, the company would not be allowed to make medical claims about its ability to treat or cure COVID-19.
- Asked about this claim about oleandrin being a "cure" for COVID-19, Whitney said he stands by it "100%."
What they're saying: "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."
- Whitney said that by "cure" he means the symptoms go away quickly "in the vast majority of cases."
A source briefed on the situation said Whitney has so far provided no evidence to give the administration confidence about his claims.
- Whitney disputed that. "Actually, we have provided that," he said. 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."
- "We have something that we believe will address the problem and we want to make it available," he added. "We believe we should be given the opportunity to demonstrate that in a hospital clinical trial setting and we believe that must happen now and not a month from now."
What we're hearing: Hahn appears to be resisting Whitney's efforts — at least so far — despite Trump expressing his enthusiasm for the FDA to approve oleandrin. In a sign that has reassured some administration officials worried about the oleandrin campaign, Whitney has privately complained that the FDA has been dragging its feet.
Go deeper: Read the full story in the Axios stream.