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Health & Fit Oleandrin, Covid-19 Treatment Pitched to Trump, Could Be Dangerous

08:20  21 august  2020
08:20  21 august  2020 Source:   nytimes.com

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A plant extract trumpeted this week as a “cure” for Covid-19 by the leader of a pillow company is untested and potentially dangerous, scientists say.

a close up of a flower: The extract is derived from Nerium oleander, a flowering shrub native to the Mediterranean. © DeAgostini/Getty Images The extract is derived from Nerium oleander, a flowering shrub native to the Mediterranean.

Mike Lindell, the chief executive of My Pillow and a big donor to President Trump, told Axios that the president was enthusiastic about the drug, called oleandrin, when he heard about it at a White House meeting last month.

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“This thing works — it’s the miracle of all time,” Mr. Lindell, who has a financial stake in the company that makes the compound and sits on its board, said in an interview with CNN’s Anderson Cooper on Tuesday. When CBS asked Mr. Trump about oleandrin for Covid-19, Mr. Trump said, “We’ll look at it.”

The unsubstantiated claims alarmed scientists. No studies have shown that oleandrin is safe or effective as a coronavirus treatment. It’s unclear what dose the purported treatment would have, but ingesting even a tiny bit of the toxic shrub the compound comes from could kill you, experts say.

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“Don’t mess with this plant,” said Cassandra Leah Quave, a medical ethnobotanist at Emory University.

Oleandrin is derived from Nerium oleander, a lovely, flowering Mediterranean shrub that is popular with landscapers and responsible for many cases of accidental poisoning. Oleandrin is the chemical that makes the plant deadly, Dr. Quave wrote in an article in The Conversation.

Ingesting any part of the plant — or even eating a snail that previously munched on some of its leaves — can cause an irregular heart beat and kill humans and animals, she and other doctors and scientists said.

So why would anyone think oleandrin could be a treatment for Covid?

It’s not uncommon for plants — even poisonous ones — to generate interest as treatments for disease. Robert Harrod, a professor at Southern Methodist University, has studied oleandrin’s potential to fight a type of leukemia, for example. Although Dr. Harrod said that using oleandrin to treat the coronavirus was not yet more than “an intriguing idea,” he’s rooting for it to work.

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The U.S. Army Medical Research Institute of Infectious Diseases conducted a lab test in May to determine if oleandrin could stop coronavirus infection in cells. The results were “inconclusive,” and the agency opted to discontinue this line of research, according to Lori Salvatore, a spokeswoman for the Army’s Medical Research and Development Command.

Another cell study, which has not yet been published by a scientific journal, involved two employees of Phoenix Biotechnology, a San-Antonio based company that Mr. Lindell has a stake in. According to its website. the company has spent the last 20 years exploring the health benefits of oleandrin.

The study found that oleandrin could block the coronavirus in monkey cells in a test tube. But these so-called in-vitro experiments do not tell us much, according to scientists, one of whom conducted the study.

“The testing of antivirals on cells is only the first step, and promising results must be followed up with animal testing,” Scott Weaver, a virologist at University of Texas Medical Branch at Galveston, and one of study’s authors, said in a statement. “There are many drugs like this one that look promising during initial in vitro testing, but then fail later for a variety of reasons.”

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That cell study also raises questions about the drug’s safety, said Dr. Melissa Halliday Gittinger, a toxicologist at the Georgia Poison Center and a professor at Emory University School of Medicine. An oleander dose as small as 0.02 micrograms per milliliter can be fatal. The paper does not offer a suggested dose for people, but some of the lab tests on cells involved concentrations that were substantially higher.

In his interview with Mr. Cooper on CNN, Mr. Lindell repeatedly stated that oleandrin was shown to be safe in a study of 1,000 people. But that is misleading: No known study examining the safety of oleandrin as a treatment for coronavirus or anything else has ever been conducted in such a large group.

Pressed on what Mr. Lindell might have been talking about, Andrew Whitney, vice chairman and director of Phoenix Biotechnology, said that Mr. Lindell misspoke. A company provided 1,000 cancer patients in Honduras with a drug containing oleandrin on a “compassionate” basis, he said. It was not a controlled study.

Mr. Whitney, who was also present at the White House pitch meeting, said he is nonetheless convinced that oleandrin can safely treat coronavirus because two early clinical trials, both of which used Phoenix Biotechnology’s compound, found that it could safely treat cancer patients. These studies, however, were small, each involving around 50 people, and did not prove the drug’s effectiveness.

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Still, Mr. Whitney said he is “100 percent sure” that oleandrin is effective at treating the coronavirus because of compelling data in people. He said it was too soon to elaborate, but confirmed that he was referring to a study run by Dr. Kim Dunn, an internist in private practice in Houston.

That study was not a rigorously controlled clinical trial. In an interview, Dr. Dunn said that Phoenix Biotechnology provided about 200 samples of an extremely low-dose supplement of oleandrin to give to roughly 80 people who were either infected with the coronavirus or live with infected people. Undergraduate students studying medicine were asked to evaluate its impact on volunteers’ immune systems with the help of mentors at the Schull Institute in Houston, she said.

“I don’t know yet what they found,” Dr. Dunn said, adding that no side effects had been identified so far.

Could Phoenix Biotechnology sell oleandrin as an over-the-counter supplement?

Possibly. And that’s part of why the compound has become a hot topic this week.

Mr. Whitney said that he hopes that Phoenix Biotechnology will be able to test the drug among people infected with coronavirus in hospitals. But he’s also looking into selling the extract as an over-the-counter dietary supplement. Vitamins, weight-loss pills, melatonin and other dietary supplements are not required to go through the drug testing review process of the Food and Drug Administration to be sold.

If Phoenix Biotechnology sold the product over the counter, it would be prohibited from labeling oleandrin as a cure for Covid. But scientists still worry that people will believe it works, especially given the company’s connections to the Trump administration.

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Mr. Lindell is not only the face of My Pillow but also the honorary chairman of Trump’s re-election bid in Minnesota. At a Rose Garden event in March, Mr. Trump introduced him as a “friend.” (“Boy, do you sell those pillows,” the president said.) And Mr. Lindell said on CNN that he was friends with Dr. Ben Carson, the secretary of housing and urban development and a member of the White House Coronavirus Task Force. Dr. Carson also was at the oleandrin pitch meeting at the White House in July and is enthusiastic about the drug, according to Axios.

This is not the first time that Mr. Lindell has been criticized for exaggerating the scientific merit of a product. His company has claimed that its pillows could treat insomnia and sleep apnea. At one point, the company said in an ad that its pillows had been tested in a randomized and placebo-controlled study. “Clinical sleep study proves: ‘78% showed improvement in sleep!’”

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After a lawsuit by California prosecutors and investigation by Truthinadvertising.org, the company stopped making those claims. As it turned out, the study did not use a placebo control and had not been scientifically reviewed. There was no evidence that Mr. Lindell’s pillows could treat sleep disorders.

When asked about this suit on CNN, Mr. Lindell said: “I have been attacked with frivolous lawsuits that I had to settle because I backed the greatest president this country has ever seen in history.”

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usr: 1
This is interesting!