Allies of Donald Trump have promoted a plant extract called oleandrin to people seeking to ward off Covid-19. The plant the extract is derived from, oleander, is poisonous and there is no proof the compound is either safe or effective to treat or prevent Covid-19, experts say.
But unlike other unproven and potentially dangerous Covid-19 “cures” pitched by Donald Trump and his supporters, including the prescription antimalarial hydroxychloroquine, experts fear this compound could easily reach the public as a dietary supplement.
“Supplements are like snake oil, in the sense they are not regulated by the FDA,” said Martin Ronis, a professor in Louisiana State University’s department of pharmacology and experimental therapeutics, referring to the US Food and Drug Administration.
While pharmaceutical companies must show the FDA drugs are safe before they go to market, dietary supplements are considered “food” in the US and thus must be proven unsafe before they are removed from the market. Because of this regulatory structure, Ronis said it would be possible for the company behind the plant compound – Texas-based Phoenix Biotechnology – to bring the extract to market.
“You can essentially make all kinds of apocryphal claims about supplements,” said Ronis.
One of Phoenix’s board members is Mike Lindell, a prominent Trump backer, pitchman, and CEO of MyPillow. Lindell chairs Trump’s re-election effort in Minnesota.
While Lindell has pitched Phoenix’s plant extract as a coronavirus cure on TV and to the president’s coronavirus taskforce, the company also quietly received $5m in funding from an undisclosed investor, patented its extract for use in Covid-19, and promoted an early study in monkey cells as proof of efficacy – an assertion one of the study’s own authors denies.
Lindell told the TV host Greg Kelly, an anchor on the conservative Newsmax network: “I started using it myself and giving it to friends and family who tested positive.”
The interview was one of several television appearances about oleandrin and is prominently displayed on the company’s website.
“Is he allowed to do that?” Kelly laughed as he asked his other guest, Andrew Whitney, the vice-chairman and fellow director of Phoenix Biotechnology.
“Well, I’m doing it as well,” Whitney replied, “and so is everyone else at the company, because we believe in the product, Greg. We know it works.” Phoenix Biotechnology did not respond to an emailed request for an interview.
The Washington Post has reported that Whitney has visited Trump in the White House and pitched oleandrin to him.
Oleandrin has not been approved to treat any medical disorder. The supplements industry has also opposed introducing oleandrin to the market.
“The unanimous opinion is that this is a stupid idea and no one should allow an oleander supplement to get close to their mouth,” said Loren Israelsen, president of the United Natural Products Alliance, in a statement to a trade publication.
Phoenix Biotechnology has released only one study on oleandrin’s use against Covid-19. The study was published in what is called a “pre-print”, which means it is not peer-reviewed. Two of the authors had a financial stake in Phoenix Biotechnology. The study, called an “in vitro” study, examined oleandrin’s effect on monkey cells in the laboratory.
Pharmaceutical companies looking for FDA approval typically take drugs through a long pipeline of testing including in pre-clinical trials, in non-human primates, and then in a series of clinical trials testing for safety and dosing, leading up to a double-blind, placebo-controlled randomized trial for efficacy.
If Phoenix sought approval for its product, the pre-print it published would represent a concept for potential study at the very beginning of this pipeline. The median cost of bringing a drug to market is $985m, according to a recent study in the Journal of the American Medical Association. Most new drugs fail.
Phoenix has conducted two clinical trials for safety of oleandrin in cancer treatment, but both were small. Phoenix proposed providing oleandrin in what appears to be a liquid, according to its website.
Although Whitney said in his interview with Kelly that Phoenix has researched oleandrin for “25 years”, the earliest research related to the company appears to be from 2002. Phoenix was incorporated in 2003, according to a press release.
Phoenix received a patent for its extraction process in 2005, and in that time it has sponsored research at several institutions, including University of Texas San Antonio, the MD Anderson Cancer Center and Duke University.
The company appears to be moving ahead in its efforts to monetize oleandrin. The “pre-print” was published on 15 July. The company filed for patents in the US on 18 July and earlier in Australia. The American patent was reportedly granted on 29 July, and Phoenix told the US Securities and Exchange Commission it received $5m from a single, unnamed investor on 7 August.
Source: US Politics - theguardian.com
