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.'”
- 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.
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.
- 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.
- 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.
- In response, Whitney described Hahn as “immensely professional” but added: “The process is too slow. … We ought to be given an opportunity to test this. Call my bluff!”
- Whitney has invoked his meeting with the president to apply further pressure on administration officials to approve or authorize oleandrin. (Whitney responded, “If I was the president I would want a solution to this situation. And if our solution is perceived as an effective one, or a potentially effective one, I would want to see it tested.”)
- An FDA spokeswoman declined to comment.
Inside the oleandrin campaign
The science: Oleandrin is an extract from the oleander plant. Researchers have suggested that it could be useful to treat cancer because of the way it affects cells, and that it could enhance the effects of other cancer therapies.
- 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.
- Asked about oleandrin’s potential efficacy as a COVID-19 treatment, Lewin told Axios, “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.”
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.”
- 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.”
Between the lines: Whitney enlisted Lindell in his effort to speed up approval of the botanical product.
- In an interview with Axios on Saturday, Lindell spoke passionately in support of oleandrin and said he was such a believer in the botanical that he now has a financial stake in Phoenix Biotechnology and wants to ensure every American has access to this COVID-19 “cure.”
- Lindell said he first became aware of oleandrin when Whitney called him on Easter Sunday and said it could cure COVID-19.
- Lindell said he then took the information to Carson, who got on board.
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.
Another influential Trumpworld figure also touted Whitney’s product. The first example I could find of a media outlet floating oleandrin as a potential treatment for COVID-19 was an April 23 article on John Solomon’s website “Just The News.”
- In his article, Solomon described oleandrin as “a rising star in the biomedical world” and quoted Dr. John Dye of the United States Army Medical Research Institute of Infectious Diseases, saying his laboratory planned to test what effect oleandrin would have on “tissue culture assays” for COVID-19.
- 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.”
- Solomon is a frequent on Sean Hannity’s Fox News show and is close to Rudy Giuliani. President Trump has waxed lyrical about Solomon, saying he deserves a Pulitzer Prize for his coverage of the Russia investigation. A story from Solomon can carry extra weight in the Oval Office.
The bottom line: Scientists around the world are in a race for cures, treatments and vaccines for COVID-19. Government regulators are investigating hundreds of products. When a biotech executive like Whitney can take his case directly to the president, it casts doubt over the scientific rigor of the drug development process.
This content was originally published here.