In recent days, a ferocious attack has been mounted against a natural supplement known as oleandrin that is said to be a potential cure for the virus unleashed on the world by the Chinese Communist Party (CCP). Video of one of the supplement’s champions, My Pillow entrepreneur Mike Lindell, being savaged by CNN’s Anderson Cooper has gone uber viral.
Other examples now abound as members of the leftist media, unnamed government officials, and assorted so-called “experts” have derided the oleandrin option. They insist that: 1) this molecule (PBI-05204) derived from the common American oleander plant, is unsafe; 2) its effectiveness against COVID-19 is unproven; and 3) its proponents are trying to short-circuit the Food and Drug Administration’s (FDA’s) review required for putative treatments such as this.
None of those charges is true.
While positive information regarding oleander-based substances seems to have been scrubbed online – one of Cooper’s claims that “this has never been tested in humans” seems easily refuted. A 2014 PubMed.gov report details its testing in humans with advanced tumors.
Conclusions PBI-05204 was well tolerated in heavily pretreated patients with advanced solid tumors.https://pubmed.ncbi.nlm.nih.gov/24919855/
In phase II clinical trial on human patients this year it did not meet the intended efficacy mark set for the study but warranted further study. They recommended a randomized phase II trial.
PBI-05204 did not meet its primary endpoint for OS in this study. Recent preclinical data indicate a role for PBI-05204 against glioblastoma multiforme when combined with chemotherapy and radiotherapy. A randomized phase II trial is currently being designed.https://pubmed.ncbi.nlm.nih.gov/32452588/
Additionally, major academic institutions and national laboratories across the country have conducted multiple studies on the oleandrin compound in recent years. These include the University of Texas Medical Branch in Galveston, the U.S. Army Medical Research Institute of Infectious Diseases at Ft. Detrick, the National Institutes of Health, the Medical College of Wisconsin, and Southern Methodist University.
Oleandrin is a tiny molecule derived from a flowering plant that is called Nerium oleander, commonly known as oleander. It is widely grown in southern, warmer climates in the United States. “it is so widely cultivated that no precise region of origin has been identified, though it is usually associated with the Mediterranean Basin.”
Oleander leaves and branches can be toxic. But so can be other natural products we routinely consume like nutmeg, menthol or alcohol. The safety of the tiny subset of the oleander plant represented by the oleandrin molecule, however, has already been established through FDA Phase 1 & 2 clinical trials in an oncology application. Phoenix Biotechnology says that “over 1000 cancer patients have used the extract, with no adverse side effects.‘
Other research suggests oleandrin may have broad antiviral activity against enveloped viruses by reducing the incorporation of the envelope glycoprotein into mature particles, a stage of the infection cycle not targeted by modern HAART.
Second, Phoenix Biotechnology, the company that has driven the research on this remarkable compound for the past twenty-five years, has lab results, ongoing animal trials, and compelling human data that it has shared with the FDA indicating the effectiveness of oleandrin against COVID-19. This finding could be quickly and easily confirmed under supervised conditions in a hospital environment.
Third, as a natural botanical product, Phoenix Biotechnology has sought to bring it to market as both an FDA-approved drug and as a natural supplement. The company has been engaged in that formal process with the government since April. To date, there has seemingly been no progress on either track. And tragically, during that period, tens of thousands of Americans may have needlessly succumbed to the coronavirus – 25,000 of them in the last two months alone.
Convinced that they have a safe and potentially highly efficacious solution to the CCP pandemic and that the American people are being denied potentially life-saving help, Phoenix Biotechnology quite logically and responsibly sought to bring the promise of oleandrin to the attention of the White House COVID-19 Task Force. This enterprising and public-spirited company has concluded, moreover, that its civic duty requires it: 1) to make oleandrin available to the public at a low cost (currently projected to be less than $100 per 5-7 day dose) and 2) to have the capability to start producing it in large quantities immediately. It could generate an estimated 500 million doses within 60 days.
Clearly, it is high time that the FDA got around to approving these two modest initiatives aimed at protecting large numbers of Americans who may otherwise needlessly be imperiled by the coronavirus. The company is not asking for blanket authorities or approvals. It is merely seeking the right to immediately begin testing in a hospital environment. Given that the safety of this compound has already been established in previous FDA trials in humans, one cannot help but ask: What’s the downside in doing such testing? And in the meantime, let those of us who want to use oleandrin purchase it as a natural supplement.
Sadly, as Andrew Whitney, Phoenix Biotechnology’s executive chairman puts it, “Despite roughly nine months of intensive efforts, unlimited resources and top priority, the search for an effective treatment for COVID-19 has yet to deliver a single FDA-approved drug, therapeutic or vaccine – let alone a cure. We believe we can contribute a low-cost solution to the problem.”
Given the demonstrated safety and apparent effectiveness of oleandrin against the coronavirus, one can only conclude that the venomous attacks on the prompt and widespread testing of this natural product on humans and its availability as a natural supplement are motivated by something other than science or the public interest.
To the extent that such opposition is animated by a desire to perpetuate the national nightmare inflicted by the COVID-19 pandemic until November 4th, it needs to be called out, not indulged. If those who engage in what Mr. Whitney calls “cure-canceling” – whether through venomous and unfounded press attacks or perfidious bureaucratic sandbagging – effectively contribute to the needless deaths of more Americans, they will have blood on their hands and must be held accountable for it.