What Is Oleandrin? Trump Reportedly Wants FDA to Approve Plant Extract for Coronavirus

President Donald Trump reportedly wants the Food and Drug Administration (FDA) to approve 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 the president during an Oval Office meeting in July, which involved Housing and Urban Development (HUD) Secretary Ben Carson, MyPillow founder and CEO Mike Lindell and Andrew Whitney, an executive at Phoenix Biotechnology—a company that is developing and pushing the oleandrin product to the Trump administration.

During the meeting, Trump "basically said: ...'The FDA should be approving it,'" Lindell told Axios. But what is oleandrin and does the substance have any medical uses?

Oleandrin is a botanical extract from the oleander plant—an evergreen shrub or small tree that is highly toxic to humans and many animals if any part is ingested. Oleandrin is one of several toxic compounds that the plant contains.

Some "in vitro" research—a term used to refer to studies done in test tubes rather than animals or humans—has suggested that the substance could potentially be useful as a treatment for various cancers, including those of the colon, pancreas and prostate.

Furthermore, one in vitro study published in the journal Fitoterapia 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 drugs from the University of Melbourne in Australia, 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" for its effectiveness against SARS-CoV-2—the virus that causes COVID-19.

While one paper published in July by researchers from the University of Texas at Galveston indicated that oleandrin inhibits SARS-CoV-2 in monkey kidney cells, its conclusions should be viewed with caution. The paper, which lists Robert Newman—chairman of Phoenix Biotechnology's scientific advisory board—as an author has not been peer-reviewed. This means it is yet to undergo evaluation by experts in the field in order to be published in a scientific journal.

In May 2020 the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) conducted some preliminary testing of oleandrin against SARS-CoV-2. The results were "inconclusive," a spokesperson, Caree Vander Linden, told Axios.

"Additionally, USAMRIID was contacted by University of Texas Medical Branch at Galveston, indicating that they were also testing it," Vander Linden said. "Given our inconclusive results, and having other high priority therapeutics to assess, we did not continue with this line of research."

Aside from the aforementioned research, there appear to be no other published papers testing oleandrin's efficacy against SARS-CoV-2 in animals or humans. However, Whitney told Axios on Saturday that an unpublished lab study testing oleandrin on humans as a COVID-19 treatment is in the process of being peer-reviewed.

Whitney says that oleandrin can "cure" COVID-19, causing symptoms to disappear "in the vast majority of cases," Axios reported, although there is currently insufficient publicly available evidence to back up these claims.

"We have something that we believe will address the problem and we want to make it available," Whitney told Axios. "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."

Donald Trump
U.S. President Donald Trump returns to the White House with First Lady Melania Trump (R) after a weekend in Bedminster on August 16, 2020 in Washington, D.C. Eric BARADAT / AFP) (Photo by ERIC BARADAT/AFP via Getty Images

The company is exploring oleandrin as a potential COVID-19 treatment—something which would require the drug to undergo rigorous human clinical trials. However, Phoenix Biotechnology is also pushing the FDA to allow oleandrin to be sold as a dietary supplement. This could happen quickly, according to Whitney, although the company would not be allowed to make claims about its effectiveness in treating or curing COVID-19.

Oleandrin's use 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 to arrange the July Oval Office meeting where Whitney discussed oleandrin's use against COVID-19, The Washington Post reported.

Some senior administration officials have expressed their concern over oleandrin being pushed as a COVID-19 treatment at the top of the U.S. government.

"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," a senior administration official told Axios.

In March, Trump pushed FDA commissioner Stephen Hahn to authorize the emergency use of the anti-malarial drug hydroxychloroquine for the treatment of COVID-19.

The agency subsequently issued an Emergency Use Authorization (EUA) for the drug. however, the FDA revoked this in June based on results from a large, randomized clinical trial in hospitalized patients "that found these medicines showed no benefit for decreasing the likelihood of death or speeding recovery."

Newsweek has contacted the White House for comment.