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.
Driving the news: 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.'”
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.
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.
“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.”
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.
- Phoenix Biotechnology’s website listed Newman as the president of the company and a member of its board of directors until quite recently (Google’s cache shows he held both roles as of August 12th).
- 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.”
- Asked when had Newman stepped down as president given that he was listed as president the night before Axios’ email, Whitney replied, “Conversations about reorganization have been ongoing this week.”
Citing the University of Texas study and HUD Secretary Ben Carson’s belief in oleandrin, Whitney said regulators ought to take his product seriously. “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 unapproved botanical and has shared it with his family and friends. He said he believes it has kept him from getting COVID-19 and has cured other people. (No published clinical studies show the botanical cures or prevents COVID-19. Nor has the FDA said the product is safe or fit for this purpose.)
- 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.”
- “Why wouldn’t the guy that’s on the task force [Carson] bring the cure to the president if it’s getting stopped at other places?” Lindell added.
Lindell said that in July’s Oval Office meeting, he was joined by President Trump, Carson, Whitney, and briefly White House chief of staff Mark Meadows.
- Lindell said that Stephen Hahn — the head of the FDA, which studies and approves medical treatments — wasn’t there.
- “There were two other people in the room, one of them was not Steve Hahn because I’ve seen a picture of Steve Hahn before and it wasn’t him,” Lindell said.
- Whitney said he approached Lindell because he thinks he’s one of the country’s greatest businessmen and was impressed that Lindell mobilized MyPillow to make face masks.
There is a lot more at the link above. It is laid out in a bullet point type manner. If you want the full story about the pressure being put on the FDA to certify an unproven possibly dangerous extract from a poisonous plant. If you read the story along with the quotes I used you will see that this is all about greed. Knowing that tRump is easy to sway especially where his big money donors are concern people are using this to get a product on the market and certified to do stuff that has not been proven and could actually be harmful. Hugs