President Donald Trump wants to report that the Food and Drug Administration (FDA) approves the plant extract oleandrin as a potential treatment for COVID-19, despite a current lack of evidence that it would be effective for this purpose.
The extract was promoted to president during an Oval Office meeting in July, involving Secretary of Housing and Urban Development (HUD) Ben Carson, MyPillow founder and CEO Mike Lindell and Andrew Whitney, an executive at Phoenix Biotechnology-a company – a company that develops and pushes the oil spill product to the Trump administration.
During the meeting, Trump said “in principle: … ‘The FDA should approve it,'” Lindell told Axios. But what is oleandrin and does the substance have medical use?
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Oleandrin is a botanical extract of the oleander plant – an evergreen shrub like a small tree that is very toxic to humans and many animals as one part is absorbed. Oleandrin is one of several toxic compounds that the plant contains.
Some “in vitroResearch – a term used to refer to studies done in test tubes instead of animals as humans – has suggested that the substance could potentially be useful as a treatment for various cancers, including those of the colon, pancreas and prostate.
Another one in vitro study published in the journal Phytotherapy found that the compound inhibits the ability of HIV to establish an infection, although it should be noted that the results of test tube studies do not always translate into animal or human models.
Professor Sharon Lewin, an internationally renowned expert on antiviral medicine from the University of Melbourne in Australia, told Axios: “Oleandrin seems to have antiviral activity at high doses in a test tube model. You would definitely like to see more work done on this before yourself. consider a human trial “for its effectiveness against SARS-CoV-2 – the virus that causes COVID-19.
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While one paper published in July by researchers at the University of Texas at Galveston indicated that oleandrin inhibits SARS-CoV-2 in monkey kidney cells, its conclusions need to be viewed with caution. The paper, which Robert Newman – chairman of the Phoenix Biotechnology Scientific Advisory Board – cites as the author, has not been peer-reviewed. This means that it still needs to be evaluated by experts in the field in order to be published in a scientific journal.
In May 2020, the U.S. Army Medical Research Institute (USAMRIID) conducted some preliminary testing of oleandrin against SARS-CoV-2. The results were ‘unintended’, a spokeswoman, Caree Vander Linden, told Axios.
“In addition, USAMRIID was contacted by the University of Texas Medical Branch in Galveston, indicating that they are testing it as well,” said Vander Linden. “Given our incomprehensible results, and having other high-priority therapeutic drugs to assess, we have not continued with this line of research.”
Apart from the aforementioned study, there are no other published papers that test the effectiveness of oleandrin against SARS-CoV-2 in animals than humans. However, Whitney told Axios on Saturday that an unpublished lab study is testing oleandrin on humans if a COVID-19 treatment is in the process of peer-reviewed.
Whitney says oleandrin COVID-19 can “cure, causing symptoms to disappear” in the vast majority of cases, “Axios reported, although there is currently not enough publicly available evidence to back up these claims.
“We have something we believe addresses the problem and we want to make it available,” Whitney Axios said. “We believe we should get the chance to demonstrate that in a hospital clinical trial setting and we believe that should happen now and not a month from now.”
The company is investigating oleandrin as a potential COVID-19 treatment – something that requires the drug to conduct rigorous human clinical trials. However, Phoenix Biotechnology is urging the FDA to allow oleandrin to be sold as a dietary supplement. This could happen quickly, according to Whitney, although the company would not allow claims about its effectiveness in treating or curing COVID-19.
The use of Oleandrin against COVID-19 is supported by Carson and Lindell – a Trump backer who recently bought a stake in Phoenix Biotechnology. Lindell – a personal friend of Carson and the president – helped arrange the Oval Office meeting in July, where Whitney discussed the use of oleandrin against COVID-19, The Washington Post report.
Some senior administration officials have expressed concern about oleandrin being shoved as a COVID-19 treatment at the top of the U.S. government.
“The involvement of the Secretary of HUD and MyPillow.com in printing a dubious product at the highest levels should not give Americans comfort about their health and safety during a raging pandemic,” an administration official told Axios.
In March, Trump urged FDA Commissioner Stephen Hahn to authorize the emergency use of the anti-malarial drug hydroxychloroquine for the treatment of COVID-19.
The agency later issued an emergency use authorization (EUA) for the drug. however, the FDA withdrew this in June based on results of a large, randomized clinical trial in patients admitted to the hospital “that these drugs found no benefit in reducing the chance of death or faster recovery.”
Newsweek contacted the White House for comment.