Based on the proposed dosage discussed with FDA, a person would need to take 600 dosages simultaneously to “reach a toxic level,” Whitney said. The NDIN had been submittted by Ozelle Pharmaceuticals Inc. in San Antonio. “Indeed, among the responses to the more than 1,000 NDI notifications released by FDA to date, AHPA identified only seven expressing known safety concerns in this manner,” the trade association said in a statement. All of them “universally confirmed that oleander is highly toxic to both humans and animals and is not recognized as a dietary ingredient or supplement,” Israelsen wrote in a memo to his colleagues. “It’s the miracle of all time,” he proclaimed. In July, the University of Texas published a paper which described its effects on the kidney cells of monkeys infected by coronavirus. And while there’s no evidence it has any beneficial effects against Covid-19, there’s ample evidence that it’s dangerous. A biopharmaceutical firm stands by the safety of the plant compound oleander amid reports in the mainstream press that the Trump administration is being lobbied to support an unproven and dangerous product to treat COVID-19. Oleandrin is being promoted as the new COVID-19 snake oil – but it is a deadly toxin. “I heard about the oleander extract from Mike,” Carson, a former neurosurgeon, said in an interview, according to the Washington Post. Phoenix Biotechnology has studied oleander for a quarter century and is pursuing two very distinct avenues with FDA. He dismissed what he described as a false narrative that the biopharma company doesn’t follow protocols and “blew into the White House like some type of tumbleweed.”. A large white- or pink-flowering bush or small tree, oleander is grown as an ornamental plant in many parts of the U.S. and elsewhere, including North Africa, the Mediterranean and southwestern Asia, according to the advisory. “All parts of the plant contain a poisonous substance called oleandrin, known technically as a cardiac glycoside, and other similarly toxic constituents,” ABC cautioned. Add oleandrin to bleach and hydroxychloroquine on the list of quack remedies promoted by President Donald Trump to prevent or cure Covid-19. Oleandrin for COVID … Neither oleander nor oleandrin is approved by regulatory agencies as a prescription drug or dietary supplement. An FDA spokeswoman declined to answer specific questions for this story and referred a reporter to a FAQ section about potential cures and treatments for COVID-19. Oleander is in the news because in recent weeks, claims have arisen that extract from the oleander plant could be used to fight COVID-19. Now, Trump is eyeing another unproven coronavirus 'cure' at the recommendation of Housing and Urban Development Secretary Ben Carson, Axios reported on August 16. Such notifications are provided to FDA to establish the safety of an NDI before it’s marketed in a supplement in the U.S. “All parts of the oleander plant are poisonous to man and animals and serious adverse effects are associated with ingestion, inhalation and contact of mucus membranes with oleander or oleander extracts,” an FDA official, Lynn Larsen, stated in response to the notification in a letter dated Dec. 23, 1998. www.MyOleander.com Yes, yes, yes, and yes! A car cannot operate effectively or safely on a “barrel of crude oil,” but with the proper isolate equipment and expertise, “you can distill gasoline fraction out of that barrel of crude and run the car very safely and effectively on that,” he said. There's a new substance being touted as a potential treatment for COVID-19; an extract from the Oleander plant called oleandrin. Informa Markets, a trading division of Informa PLC. Phoenix Biotechnology has studied oleander for a quarter century and is pursuing two very distinct avenues with FDA. In FDA phase 1 and 2 human clinical trials for a cancer application, the compound was shown to be safe, he told Natural Products Insider in an interview. Housing and Urban Development Secretary Ben Carson and MyPillow boss Mike Lindell, a big Trump supporter, have urged Trump to look at the botanical extract, Meeting arranged by the pair with a director at company developing the product, Andrew Whitney, of Phoenix Biotechnology, claims he is '100%' sure it's a cure, But there is no peer-reviewed study to support the claim, Lindell says that in the meeting, Trump 'basically said the FDA should approve it', Senior administration official expressed deep concern that Carson and Lindell were 'pushing a dubious product at the highest levels' during the pandemic. Botanical experts, on the other hand, warned oleander is dangerous and can even cause death. In one study it was shown to inhibit the growth of human pancreatic cancer and in another as 'a novel inhibitor of HIV infectivity.'. Copyright © 2021. FDA did not immediately confirm for this story whether it had received such a notice. “We have submitted the application,” Whitney said. The United States Army Medical Research Institute of Infectious Diseases (USAMRIID) also conducted some preliminary testing of oleandrin against SARS-CoV-2 … Carson also attended the meeting along with White House Chief of Staff Mark Meadows and a lawyer. Carson is a leading expert in pediatric neurosurgery, but is not regarded as such in the fields of antiviral drugs or infectious diseases. said in a new interview that he took oleander extract, an … The President has been urged to consider the benefits of oleandrin by Housing and Urban Development Secretary Ben Carson and MyPillow founder and CEO Mike Lindell, a huge Trump fan. I am concerned by recent reports that a chemical found in the oleander plant is being touted as a potential treatment for COVID … If NYCMayor can't do it, we will! He says that the FDA has been too slow in granting approval for a clinical trial, which he believes should happen immediately. Related: FDA: Company that studied ‘Oleandrin’ as drug barred from marketing it as supplement. However, Carson added that he has "several co-morbidities" and after experiencing minor discomfort, his symptoms "accelerated" and he became "desperately ill." But Phoenix Biotechnology would need to overcome "the well-known safety concerns associated with oleander, and FDA has already spoken on this issue in the context of a new dietary ingredient notification," he explained. The homeopathic product was rolled out to the public by Phoenix Biotechnology, Inc. in October. Lindell has been touting the oleander extract for months and told Axios he, Carson, Phoenix Biotechnology executive Andrew Whitney and … Oleandrin is a cardiac glycoside - an organic compound which increases the output of the heart and increases the rate of its contractions. About the Oleander plant. Whitney said: '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, but as an American with a right of free expression, I'm telling you, I've seen it with my own eyes. “We would love to see this out there as a dietary supplement, and we’re pursuing that avenue as well as the FDA drug track.”. In a phase 2 trial involving PBI-05204, 42 patients were enrolled, with 38 of them analyzed, researchers noted in the journal The Oncologist published in 2020. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. "With respect to oleander, all parts of the plant are highly toxic, dangerous and life-threatening when ingested," Mark Blumenthal, founder and executive director of the American Botanical Council (ABC), a nonprofit, international member-based organization, said in a consumer advisory. President Donald Trump reportedly wants the Food and Drug Administration (FDA) to approve the plant extract oleandrin as a potential treatment for COVID … As an aside, many people may know this plant from the game Red Dead Redemption II, where it is plant that can be harvested and used to make poison. A Facebook post from Secretary Ben Carson is creating a buzz on social media after he credited a “very powerful therapeutic” for his quick recovery from COVID-19. Oleandra – The New COVID Snake Oil. “Certainly, botanicals have a rich history of providing health benefits, and we encourage any and all research on any botanical," he said in an interview. You'd certainly want to see more work done on this before even contemplating a human trial. Ross Ibbetson For Mailonline : Trump threatens to intervene in the Big Apple as he lashes out at Bill de Blasio after another violent weekend saw 50 people shot and seven killed. Assess the impact of a proprietary extract of Nerium oleander on COVID-19 symptoms and mortality in COVID-19 positive patients and their close contacts compared to controls that did not receive the extract. “In the course of that analysis, we got really remarkable results—an average 20,000-fold reduction in viral infectivity,” Whitney said, adding the reduction occurred within 24 hours. ' Â. UTMB also examined what happens if the cells were exposed to the product and the virus was introduced several hours later. "Nobody’s suggesting here that we need to run into the street yelling ‘eureka’ on the back of that work.”. This response by the FDA has reassured some officials within the Trump administration, according to Axios, who worry about the president's support for the experimental oleandrin. The company would need to clearly describe conditions of use, dosage forms and quantities, demonstrating the "same reasonable expectation of safety that’s required of all dietary supplements before it could bring it to market," McGuffin added. Oleandrin - an extract of the plant known for its pink and white flowers - was shown to inhibit the coronavirus in the kidneys of monkeys, in a July study by University of Texas at Galveston. He’s talking about Oleander. In a phase 1 trial, 46 patients received PBI-05204, Phoenix Biotechnology's new botanical drug—a Nerium oleander extract, according to a study in the journal Investigational New Drugs published in 2014. Lindell, who thanked God that Trump got elected in a White House speech back in March, promoted oleandrin during a White House meeting with Trump in July.There’s no public data that oleandrin, an extract from the toxic oleander plant, has ever been tested in humans or animals against COVID-19.. According to Jonathan Swan reporting for Axios, Mike Lindell, the Founder and CEO of MyPillow, Inc. recently promoted the use of not pillows but oleandrin as a … Number 8860726. With COVID-19 cases and deaths rising in the US and globally, identifying new therapies to prevent and combat the virus is a top priority. In Vitro Study. Lines and paragraphs break automatically. Experts unpack the dangerous, toxic effects associated with oleandrin, an extract of oleander that President Trump reportedly believes may help with COVID-19. "The testing of antivirals on cells is only the first step, and promising results must be followed-up with animal testing. Coronavirus disease 2019 (COVID-19): There is no good evidence to support using oleander for COVID-19. Trump's latest gambit comes after his optimistic overtures about intravenous disinfectant, UV light and hydroxychloroquine. Housing Secretary Ben Carson is crediting unapproved, experimental treatments with saving his life after he became "desperately ill" following his infection with the coronavirus. Professor Sharon Lewin, an antiviral drugs expert at the University of Melbourne, said that a lot more work needed to be done. ", He added a caveat. Approximately 374,000 plant species are on Earth; humans have used more than 28,000 of them as a form of medicine. Oleandrin, a derivative of the oleander plant, is the medication that had been championed by MyPillow CEO Mike Lindell for the treatment of coronavirus. Ben Carson says he used unproven COVID-19 treatment recommended by MyPillow CEO. There are many drugs like this one that look promising during initial in vitro testing, but then fail later for a variety of reasons.”. The chief executive of My Pillow, a Trump donor, claims oleandrin is a miracle cure for Covid-19. Michael McGuffin, president of AHPA, addressed the company's strategy to bring oleander to the market as a dietary supplement. Phoenix Biotech's Vice Chairman, Andrew Whitney, told Axios that oleandrin had been tested on humans but the results of that had not yet been published. Oleander Extract for COVID-19? Nobody in their right mind.”. By Claim: I can 100% confirm...Dr. Ben Carson is talking about a powerful therapeutic...this product right here, you can get it at MyOleander.com A compound called oleandrin may show promise against coronavirus in lab dishes but any White House support for it at this point would be nonsense, experts agree. The paper said that their tests showed 'the strong inhibitory profile of oleandrin in greatly reducing infectious virus production.'. More to the point, Whitney said the human clinical trials did not yield negative reactions to the product until 16 times the proposed dosage was administered. He cited such adverse effects as abdominal pain, cardiovascular symptoms, diarrhea, nausea, peripheral neuritis and vomiting. Oleandrin is an extract of the Nerium oleander plant. “The oleandrin molecule is a tiny subset of that plant and it’s all about concentration—the amount of it you consume.”. This is right up there with the hydroxychloroquine nonsense he was (and I suppose still) pushing earlier in the pandemic.. During an Oval Office meeting in July, oleandrin was promoted to Trump—with the backing of MyPillow CEO Mike Lindell and Housing and Urban Development Secretary Ben Carson, the news website AXIOS reported. Lindell, who also sits on the board of directors of Phoenix Biotechnology and has invested in the company, told Cooper he’s been taking oleander since April. While Whitney acknowledged eating an oleander plant from someone’s back yard could be extremely toxic, he stressed the company’s extract, oleandrin, is safe, based on human oncological trials. “Consumers should not, ever, try to make a home-made remedy from or self-treat with oleander.”. Josh Long | Aug 20, 2020 A biopharmaceutical firm stands by the safety of the plant compound oleander amid reports in the mainstream press that the Trump administration is being lobbied to support an unproven and dangerous product to treat COVID-19. A White House official 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.'Â. Natural products from plants are an attractive option in the search for a cure. “People can get all caught up in this idea that oleander is this poisonous plant,” Whitney said. Tangent. Doctors say the potentially toxic chemical oleander, which is being falsely touted as a COVID-10 "cure" by an executive with ties to the White House, is dangerous. UNPA consulted with several groups regarding oleander, including ABC, the National Center for Natural Products Research (NCNPR), British Columbia Institute of Technology (BCIT), National Institutes of Health Office of Dietary Supplements (NIH/ODS) and the American Herbal Pharmacopoeia (AHP). In laboratory experiments at the University of Texas Medical Branch (UTMB) in Galveston, researchers exposed green monkey liver cells to the coronavirus and introduced Phoenix Biotechnology’s product to see how it would react. Asked why Carson was backing the unproven plant extract, a spokesman told Axios: 'The Task Force is looking at a plethora of therapeutics to fight COVID-19. 19:51, 17 Aug 2020. And here we go again – President Donald Trump is pushing oleander extract as the new miracle cure or prevention for COVID-19. The study by UT has not been peer-reviewed and one of the authors is Robert Newman, a director at Phoenix Biotechnology - the company developing oleandrin. It was through the MyPillow boss Lindell that Whitney gained an Oval Office meeting with the president, first reported by the Washington Post. None of which have been shown to be cures for COVID-19. The memo quoted Ph.D.-educated experts who raised concerns about the plant, including Paula Brown of BCIT and Ikhlas Khan of the NCNPR. Trump is reportedly encouraging the US Food and Drug Administration to approve oleander plant extract to treat Covid-19, despite the fact that the dietary supplement has not been proven to treat the disease. Oleander, she said, is a member of the dogbane family, which translates to "bane to dogs," and is part of the botanical family Apocynaceae, named after Apocynum, Greek for "dog away." , updated Trump allies push for FDA to approve another untested Covid treatment - extract from toxic oleander plant. Steven Novella on August 19, 2020. “In the course of doing that, you’d have to consume an entire pint of oil. With COVID-19 cases and deaths rising in ... am concerned by recent reports that a chemical found in the oleander plant is being touted as a potential treatment for COVID-19. “That starts to be very early evidence of what’s called prophylactic or preventative quality. Natural Products Insider is part of the Informa Markets Division of Informa PLC. Registered in England and Wales. FDA raised concerns about oleander in its response to a 1998 new dietary ingredient notification (NDIN) for oleander extract. “While we strongly support continued and expanded research into the antiviral properties of botanicals (as well as their appropriate consumer use), this is not the way to do it,” Israelsen concluded. In July, a preprint published on bioRxiv claimed that oleandrin can stop SARS-CoV-2, the virus that causes COVID-19, from replicating in cells in a test tube (2020, DOI: 10.1101/2020.07.15.203489). oleander plant and covid-19 Oleandrin, the extract of the oleander plant being touted as a cure for coronavirus, has been used in various scientific trials over the last decade. 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. Still, Blumenthal described Phoenix Biotechnology’s research as “very promising,” and he emphasized “the distinction between a scientifically studied, chemically-defined experimental new drug compound from a widely known poisonous plant and a simple home-made pill, tea, or extract made from the plant’s various parts.”. She told Axios: 'Oleandrin looks to have antiviral activity at high doses in a test tube model. In highlighting how oleandrin can be safely produced, Whitney used the analogy of gasoline as a fraction of a barrel of crude oil. Whitney said Phoenix Biotechnology has been in conversations with FDA to bring the substance to market as a dietary supplement; and, when asked if the company had submitted an NDIN to the agency, he answered in the affirmative. Expert Says "No" Oleandrin, a toxic cardiac glycoside found in the poisonous oleander plant, is making headlines as a potential treatment for COVID … Sterling, Va. – Housing Secretary Ben Carson is crediting unapproved, experimental treatments with saving his life after he became “desperately ill” following his infection with the coronavirus. Web page addresses and e-mail addresses turn into links automatically. Ross Ibbetson For Mailonline, High school student knowingly went to school with COVID-19 because they were asymptomatic and believed they did not have to quarantine 14 daysÂ, Pelosi recalls the House for vote on USPS funding as mail-in ballot crisis deepens and demands Trump mega-donor and Postmaster General Louis DeJoy testify - amid reports of mailboxes being removed across US, Jared Kushner says he has 'no fear' about sending his kids back to school amid COVID-19 pandemic, saying children 'have a six times higher chance of dying from the flu', 'Law and Order. “Oleandrin in the proposed dosing is completely safe up to 16 times the proposed amount based off of Phase 1 and 2 human trials,” he said in an email through a spokesperson. 'Â, The FDA even approved use of hydroxychloroquine in March after firm lobbying by Trump - who was taking the anti-malarial - before withdrawing approval in June, citing the 'risk of heart rhythm problems.'. The businessman, who talks to sleepless potential customers behind a mirror in one of … Whitney told Axios he was still '100%' behind the claim that oleandrin is a cure for the virus. Dr. Scott Weaver, a virologist at UTMB who participated in the in vitro study, said the lab results should be interpreted with caution, as noted in a paper on the issue. We are no longer accepting comments on this article. “Any results from initial cell culture experiments do not necessarily predict that an antiviral drug will be effective in humans," he said in a statement forwarded by a UTMB spokesman. Andrew Whitney, director and vice chairman of Phoenix Biotechnology Inc. in San Antonio, Texas, said his company has studied oleander for a quarter century and is pursuing two avenues with FDA—to bring it to market as a drug to treat COVID-19 and separately to sell it as a dietary supplement. '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.'. Like the leaves and flowers of the plant, this extract, called oleandrin, is highly toxic. oleander plant and covid-19 Oleandrin, the extract of the oleander plant being touted as a cure for coronavirus, has been used in various scientific trials over the last decade. Antiviral effects of cardiac glycosides have been shown against a range of viruses, including Herpes, Ebola, influenza and chikungunya virus. FDA: Company that studied ‘Oleandrin’ as drug barred from marketing it as supplement, Allowed HTML tags:

. All rights reserved. “That’s the difference between 70 miles an hour and 1,120 miles an hour on the freeway,” he said. Oleandrin, the extract of the oleander plant being touted as a cure for coronavirus, has been used in various scientific trials over the last decade. Dangerous Oleander Extract Not a COVID-19 Cure — "That would definitely end up killing people" by Kristina Fiore , Director of Enterprise & Investigative … 10:03, 17 Aug 2020 “This thing works,” Lindell said in a testy interview this week with CNN’s Anderson Cooper. Who drinks a pint of oil or takes 600 doses of anything? “UNPA will promptly inform the U.S. FDA if an oleander dietary supplement is promoted for sale.”, https://www.naturalproductsinsider.com/sites/all/themes/penton_subtheme_naturalproductsinsider/images/logos/footer.png. Loren Israelsen is president of the United Natural Products Alliance (UNPA), an international association representing the dietary supplement industry. For months, Lindell, who served as President Trump’s campaign manager in Minnesota, has pushed oleandrin, which is derived from the poisonous oleander plant, despite the lack of evidence to show that it works as a treatment for COVID-19. Lindell claims that at an Oval Office meeting that month, Trump essentially said: 'The FDA should be approving it. Oleandrin is a molecule extracted from the Nerium oleander plant and specifically formulated for oral administration, according to Phoenix Biotechnology. Whitney said Phoenix Biotechnology also shared anecdotal evidence with FDA related to COVID-19 as well, although he confirmed such data was not public. ... (Nerium oleander). Alarmed health officials say Donald Trump is pushing for FDA approval of an oleander plant extract to cure coronavirus. “That’s when you discover that the virus struggles to get a foothold,” Whitney said. ', The comments below have not been moderated, By This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. In the FAQ, the agency said it has not approved any medicines to treat or prevent COVID-19. Based on its review of NDIN records, the American Herbal Products Association (AHPA)—a trade group for the herbal products industry—noted it's "exceedingly rare for the agency to essentially reject a notification due to known safety concerns.".

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