President Donald Trump has shown support for the Food and Drug Administration to allow an extract from the oleander plant to be marketed as a dietary supplement or even approved as a drug to cure coronavirus even though there is no proof the extract can help combat the virus.
Axios reports that the experimental botanical extract, oleandrin, was pitched to Trump during an Oval Office meeting in July.
Housing and Urban Development Secretary Ben Carson and MyPillow founder and CEO Mike Lindell, a Trump supporter, who recently took a financial stake in the company that develops the product, are both fans of the alleged cure.
Lindell told Axios that during the meeting, Trump "basically said: …'The FDA should be approving it.'"
A senior administration official told Axios that Carson and Lindell’s involvement “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."
Several senior administration officials familiar with the internal discussions about oleandrin have raised concerns about the way the botanical extract is being promoted by the Trump administration.
There is no public data showing oleandrin has ever been tested in animals or humans for its efficacy against COVID-19, Axios reports.
But, the extract has shown some evidence of inhibiting the virus in a non-peer reviewed laboratory study.
The extract is being pushed by Andrew Whitney of Phoenix Biotechnology. He told Axios that oleandrin has been tested on humans for its efficacy against COVID-19. He said the study has not been published yet. He also said the lab study is in the process of being peer reviewed.
According to The Washington Post, Lindell helped Whitney get a meeting with Trump in the Oval Office to discuss oleandrin.
Lindell told Axios that he, Carson, at least one lawyer and, briefly, White House Chief of Staff Mark Meadows, joined Trump and Whitney for the meeting.
The head of the FDA, Stephen Hahn, was not present at the meeting, according to Axios.
A spokesperson for Carson, who supports using oleandrin to cure coronavirus, told Axios that 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 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."
Whitney said he is pursuing multiple options to get the product to market. One option is using it as a coronavirus drug, which involves clinical trials and review.
He said he is also pushing the FDA to allow oleandrin to be sold as a dietary supplement.
Whitney has claimed to administration officials that oleandrin cures COVID-19 in two days, according to a source familiar with his private comments.
If Whitney is permitted to sell the extract as a dietary supplement, the company would not be allowed to make medical claims about its ability to treat or cure COVID-19.
Whitney said that by "cure" he means the symptoms go away quickly "in the vast majority of cases."
One source familiar with the matter told Axios that Whitney has so far provided no evidence to give the administration confidence about his claims.
But Whitney said he has given information. He called the data "compelling."
"We have something that we believe will address the problem and we want to make it available," he said. "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."
He said he should be given an opportunity by the FDA to test the product.
"This isn't whipped up in a bucket in someone's back garden," he said. "There's support for this."
Lindell said he has been taking the extract and has shared it with his family and friends. He called it “the most amazing miracle thing I've ever seen in my life.”
He said he thinks it’s "being suppressed because somebody doesn't want this out there because it works."
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