“This stuff works. myoleander.com #COVID19” . . . See opportunities for #botanical to not only treat #COVID19 but to also prevent #SARSCoV2 #infection” — Tweet from Phoenix Biotechnology
This is the story of how a pharma company has milked a practically useless compound for the last 20 years, misleading its investors and offering the public hopes of miracle cures for everything from Alzheimer’s, to cancers and Covid. In July of 2020, they made the ultimate play, approaching the White House in the hopes President Trump could be sold another version of hydroxychloroquine to treat covid patients. They failed. Here then, the tale of Phoenix Biotechnology and their wonder drug, Oleander 4x.
What do you do when your star new product, Oleander 4X, and the wild claims you’ve made around its efficacy gets flagged by the FDA? How do you respond to an official warning letter from the FDA listing and condemning your fake claims and misleading marketing practices? You do what Avila Herbals and Phoenix Biotechnology have done.
You register the product for yet more clinical trials with the National Institute of Health, of course. Anything to keep up appearances and buy a few more months of sales, or if you’re a pharma company, extend the opportunity for further investment.
Trials that are funded by you (Phoenix Biotechechnology), controlled by you and will run under the auspices of medical experts you employ. No reason at all to treat the results of any data produced as highly suspect. Worth mentioning is that the current trial (other failed trials are listed below) simply seeks to assess the safety of your product in human use. The same product that you’ve been aggressively peddling as a cure-all for the last few months to any American who’d listen.
So, much like water, the product, Oleander 4X, will be shown to be safe to drink, or not. Any pharmacological effects aren’t to be studied in this trial and with good reason as, as I will show.
This is the same product, in essence, that Phoenix submitted(PBI-05204) for trials as a potential cancer treatment in 2016. I would have thought establishing safety in humans (2020 trial) would have come before you started dosing terminal cancer patients in 2016?
There are no existing human trials of your drug that have established safe dosage in humans, are there? In fact, you’re not even certain if there are side effects yet, are you? Hard to tell when your trial volunteers are terminally ill and dosed with a cocktail of serious cancer chemicals. Despite this, you still feel selling and marketing your product as a cure-all is justified.
Based on what exactly, if you don’t mind me asking? Where is a shred of scientific evidence that Oleander 4X does anything that you claim?
I’ve checked your website and, at best, you insinuate possible treatments you’ve somehow extrapolated from non-referenced and in-vitro studies. I call bullshit.
I would suggest, in the politest way possible, that your companies, their associated directors, board members, and “medical experts” have in fact been lying for the last 20 years, that you have misled the public in an effort to peddle your snake oil and mislead potential future investors. Your website’s News page reads more like a wish-list of imagined cures in a world where proof of efficacy isn’t required, merely ‘maybe’s’ and ‘looks like’ will suffice. They won’t, and I would suggest your investors to date have been grossly guilty of a serious lack of due diligence or complicity.
Phoenix Biotechnology is guilty of selling fake cures to gullible members of the public. You are peddling an unapproved drug with unproven claims. Claims are not evidence and you are well aware of your product’s continued failures.
Either company is welcome to provide actual data from registered and peer-reviewed studies validating the medical claims you make relating to Oleander 4X (shown below)and I will happily print a full retraction. I have reached out to the registered directors of both companies offering them an opportunity to respond to the above. Remember, representing data in a way meant to intentionally mislead the reader is as good as lying.
The following are medical properties your companies have claimed for Oleander 4X, either on your websites or on social media (accounts now deleted)
- AN ALL-AMERICAN NATURAL COMPOUND TO CONTEND WITH THE COVID-19 PANDEMIC[,] A Promising Response to the Coronavirus-2019 Threat[,] Proposing an entirely U.S.-developed, -sourced and -manufactured treatment for “envelope viruses” — including Coronavirus-2019 (COVID-19) — that can be available in great scale now at a low price-point.
- PBI’s research to date suggests that the extract prevents key viruses from correctly forming their protective “envelope”, rendering the virus progeny non-infective; the virus is then unable to overwhelm the host and its ability to spread itself is severely impaired. In this way, oleandrin may help “flatten the curve” and curtail the pandemic. Due to its efficacy against the viral envelope, it is considered a platform solution with wide-spectrum applicability to address multiple viral pathogens and their mutations” (bold text in original).
- “We are naturally inquisitive scientists, and so we continually experiment with new formulae to develop exciting breakthroughs. When the Guile coronavirus pandemic hit the start of 2020, we knew we couldn’t sit by without investigating possible avenues that might help the world overcome this devastating virus. We’ve partnered with Phoenix Biotechnology to make a homeopathic medicine called Oleander 4X.” Below this appears a button that hyperlinks to the website myoleander.com with the text “Visit Myoleander.com” followed by “We felt that in our farm we could potentially develop something that could help turn the tide against our invisible enemy — and we did just that.” — Source Avilaherbs.com
On Phoenix Biotechnology’s social media website https://twitter.com/PhoenixBioInc: (now closed)
- In a November 19, 2020 post, you state: “What we’ve been trying to tell everyone since March. This stuff works. myoleander.com #COVID19” . . . See opportunities for #botanical to not only treat #COVID19 but to also prevent #SARSCoV2 #infection.”
- In an additional September 11, 2020 post, you state: “Thanks @HegKong for the mention. It is truly shocking we still have not received an IND number on something that has proven to be more efficacious than the 53,000+ potential CV19 treatments tested at UTMB. The science is there. The safety is proven.” accompanied by an embedded Tweet dated September 11 stating “New potential natural treatment for COVID-19 derived from the Oleander plant proposed.”
On Avila Herbals’ social media website https://twitter.com/AvilaHerbals:
- In a November 24, 2020 post, you state: “Oleander 4X is a homeopathic remedy for flu-like symptoms. . . . NOW AVAILABLE FOR PURCHASE Oleander 4X is an OTC homeopathic . . . myoleander.com”
Claims included in the FDA complaint point to a now-defunct Twitter account https://twitter.com/PhoenixBioInc What happened there? Innocent folk don’t suddenly move their accounts or close them.
We haven’t yet dealt with Avila Herbals (the growers, manufacturers, and retail arm of Oleander 4X) and I’ll get to them in a minute. First, we need to examine Oleander itself, as a herbal extract and what is actually known about the drug.
Oleander and its known safety profile
Deaths attributed to Olendear are easily found online. This reference lists three as well as exstensive warings related to Oleander or Anvirzel, a brand name associated with drug.
- Death of an adult diabetic man: Due to consumption of oleander leaves.
- Death suspected from daily intramuscular injections: In a 43-year-old cancer patient, who used intramuscular injections of Nerium oleander extract for 2 months.
- Accidental poisoning: In a woman who attempted to self-medicate for thyroid disease.
According to an article in PubMed, the common oleander is one of most poisonous plants that have been shown to contain nondigitalis cardiac glycosides. Oleander is an idiom for plants of the N. oleander L, N. indicum, and, Nerium odorum, species. Common names include soland, lorier bol, rosebay, and rose laurel and kaner.
The plant also has shown toxicologic importance for accidents when used in folk medicines, when adults unknowingly eat parts of the plant, or food that has come into contact with the plant, such as hot-dog sticks, and in homicides or suicides.
The cardiac glycosides in oleander produce more gastrointestinal effects than those in digoxin, and the symptoms range from nausea and vomiting to cramping and bloody diarrhea. Also, it causes irritation to the mucosal membranes, resulting in burning around the mouth and increased salivation. Confusion, dizziness, drowsiness, weakness, visual disturbances, and mydriasis are central nervous system manifestations of toxicity.
The most serious side effects of oleander poisoning are cardiac abnormalities, including various ventricular dysrhythmias, tachyarrhythmias, bradycardia, and heart block.
Multiple reliable medical sources stress that Oleander should not be used outside of clinical trials. In addition, they categorically state that Oleander doesn’t have the medical evidence to support any claims for treating the following:
- To treat congestive heart failure
- To treat hepatitis C
- To treat AIDS
- To treat COVID-19
Clinical trials of PBI-05204
A Phase 2 clinical trial published in the Journal of Clinical Oncology entitled “Clinical trial of novel agent PBI-05204 in patients with metastatic pancreatic adenocarcinoma (mPDA)” established thatPBI-05204 was a non-starter for the treatment of mPDA.
Conclusions: PBI-05204 did not meet its primary endpoint for OS in this study.
A second clinical study, ClinicalTrials.gov Identifier: NCT02329717, was commissioned in 2016 with the following stated objective. ‘Efficacy and Safety Study of PBI-05204 in Patients With Stage IV Metastatic Pancreatic Adenocarcinoma’. To date, no action has been taken and no patients have been recruited.
Another study in Dallas at SMU in 2019 suggested Oleander was effective against IVT. In a study entitled, The Botanical Glycoside Oleandrin Inhibits Human T-cell Leukemia Virus Type-1 Infectivity and Env-Dependent Virological Synapse Formation, the drug was examined for efficacy in-vitro.
This suggestion (suspicious by its very nature) was immediately latched onto by Phoenix and bandied about all over its website and across social media. In-vitro is a world away from reproducing similar results in vivo, as any responsible scientist will tell you.
The Longest Road
Imagine milking a cash cow for 20 years. I am certain it reaches a point where you are simply unable to walk away from it without compromising yourself and your fellow board members. Perhaps that is the position Phoenix Biotech now finds itself in.
Whatever the reason, they are all intimately aware of their product’s continued failure to prove itself useful at anything. Oleander isn’t going to be recognized as medicine by the FDA in 2020 or in 2030. It simply doesn’t work and if anyone is aware of this, it is Phoenix. It is, after all, their product and no sensible person can refute the mountain of evidence pointing to the drug’s failure.
The business structures attached to Oleander are convoluted and complicated, with offshore companies and layered structures of businesses within businesses. Here for example, is an SEC document from 2011, 20-F SEC Filing, filed by NERIUM BIOTECHNOLOGY INC on 6/28/2011documenting just how convoluted. Nerium Biotechnology manufactures Anvirzel™ which is essentially PBI-05204 or oleander.
Can you blame the FDA and investors for struggling to keep up? You might argue at this point that all is fair in love, war, and business, and really, where is the harm? That is easily answered. Aside from a clear intent to mislead, Phoenix has tried to actively market their oleander snake-oil as a cure for Covid, based on little else other than a petri dish experiment.
They have knowlingly tried to sell the public a highly toxic drug, using their web of investors and political influence.
If anyone doubts this is about money, read the Marketwatch report here on Phoneix’s efforts to pitch Oleander to the Whitehouse as a Covid cure.
Oleandrin, an extract from the highly toxic oleander plant, which was pitched to the president by Housing and Urban Development Secretary Ben Carson and MyPillow CEO Mike Lindell in July. It should be noted that Lindell, a Trump supporter, owns a financial stake in Phoenix Biotechnology, which is developing the experimental oleandrin product. And Carson, a member of the White House Coronavirus Task Force, is a personal friend of his.
The tweet below from August of this year, highlights Andersons Cooper’s attack on Mike Lindell, accusing him of selling Snakeoil during a CNN interview shortly after.
Enter Avila Herbals
No, I hadnt forgotten about them, just wanted to ensure our long and winding road ended here. So who is Avila Herbals and how do they fit into all this? Why are they featured in the FDA warning letter? Let’s do a little digging, should we?
A visit to the Avila Herbals website will lead you to myoleander.com, run by Avila and referenced in the FDA complaint. You can view their About page here. They go to great lengths to assure you they are FDA registered. Yes, as a manufacturing facility, which coincidentally produces CBD, Avila’s main business and another steadfast favorite of the alternate health sector. A small disclaimer in the footer reminds you that Oleander is not FDA approved.
Homeopathic Products: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
I’ve highlighted the word “claims” in their disclaimer above. Its a very important word,and one that most choose to ignore. A claim is simply that, a claim. Anyone can make any claim they wish, the claim does not require any basis in fact, something worth while remembering the next time you peruse a product or drug.,
Move over to their storefront on the site and you can purchase Oleander 4X on the product page. There is no mention made of the incredibly toxic side effects of an overdose from Oleander and the risk to life. There is also no mention made of the fact that safe dosage in humans has not been established for their product. The screenshot below from myoleander.com is from their About Oleander page.
Lets examine each of these three statements in turn.
Extracts of Nerium oleander have been studied for decades.
Oleander 4X provides temporary relief of symptoms associated with flu, such as muscle or body aches, headaches, chills and fever, cough, congestion.
Where is the clinical proof for this statement? Studying something in no way suggests a product is safe. This is a misleading statement that is intentionally framed to suggest the product is safe because it has been studied. If it’s been proven safe, why is your company currently engaging in clinical trials with the sole purpose of ascertaining if it’s safe? Surely a responsible and ethical retailer would first ensure safety before recklessly marketing to the public?
Oleander-4X is a whole leaf extract, which has been shown to be safe. Oleander-4X is 100% vegan, and does not contain high-fructose corn syrup, preservatives, artificial colors, flavors, or sweeteners.
Again, where is your proof of how the product has been shown to be safe? Another intentional effort to mislead the public regarding the safety of a dangerous product.
Extracts of Nerium oleander have been used safely, with minimal side effects in thousands of people in the United States.
Oleander-4X is an all-natural homeopathic drug that can easily be taken sublingually (under the tongue).
Really, thousands you say? Where is the evidence for this statement? Have you contacted these users? Now suddenly you mention minimal side effects? Care to share the real dangers this drug poses with the public. Obviously not if you’re touting it as a cure-all.
Follow the money
In a press release, dated 28 October, Theresa Obiso, CEO of Avila Herbals announced their intention to manufacture Oleander 4X on behalf of Phoenix Biotechnology. According to the press release, Avila has a vested interest to the tune of $4.5 million in Oleander. It’s only natural they would want to see it succeed and establishing it in the alternate health market as a cure-all would be in the companies interest. The release states;
Since Q2 CY2020, Avila Herbals and its partners have invested over $4.5 million dollars into the development and commercialization of these products in the New River Valley of Virginia.
The press release also reiterated Phoenix’s misleading statements regarding Oleander.
To date, Phoenix has identified potent antiviral activity against Ebola and Marburg viruses, cytomegalovirus, herpes simplex viruses, HIV and HTLV-1, and SARS-CoV-2.
I would suggest that the timing of this shared venture was hugely influenced by the Covid pandemic and that both companies viewed Oleander 4x as the perfect cash cow. Continued failure to introduce oleander, in its various guises and under different pseudonyms, into the pharmaceutical arena in the US has meant that the only viable market left to exploit is the natural healthcare one. An arena where homeopathy rules supreme and evidence of efficacy is an alien concept.
Has Avila simply fallen foul of Phoenix’s 20-year-old marketing ploys or are they actively engaged in furthering the Oleander fairy tale?
There has been an orchestrated campaign to take Oleander 4X mainstream and it had proven quite successful. This, from an article in the Palm Beach Post, entitled ‘Oleander extract sales rocket after Ben Carson touts it for COVID. But is it safe?’ on the 22nd of November.
“We just launched this product at the end of October, and sales are up over 65,000%,” said Richard Obiso, a doctor of biochemistry who two years ago co-founded the Virginia-based manufacturing company Avila Herbals with his wife, Theresa Obiso, a doctor of microbiology.
Carson later admitted he survived Covid because of proper medical intervention, but that didn’t stop him tweeting initially that Oleander 4x had made him feel ‘much better’. Not surprisingly, he was hospitalized as a consequence of his Covid infection and no doubt, drinking Oleander played a role in that. Our bodies don’t tolerate poisonous materials well, particularly when we are fighting a viral infection. The article continues;
“It is a common misconception to think that plants, being natural, including oleander, may be safer alternatives to pharmaceuticals,” Molina said.
But that hasn’t stopped Palm Beach County-based Carson, who, along with President Donald Trump and My Pillow founder and multi-millionaire Mike Lindell — who is on the board of directors of Avila’s partner company Phoenix Biotechnology — from pushing the idea that oleander extract can help treat or cure COVID-19.
Phonix is starting to run out of options. Their application to the FDA to market Oleandrin as a supplement was declined in September this year. It would appear that even Phoenix is starting to fall foul of its own marketing strategies. Confusion surrounding the different names it has used over the last twenty years no longer simply serves to “baffle with bullshit’, it’s also come home to roost, as the FDA’s response showed.
In a follow-up call with FDA, the agency suggested to Phoenix Biotechnology that the safety data provided in the NDIN failed to meet “formal requirements because it was based upon safety data for PBI-05204, and not based upon a determination of safety for our dietary ingredient when used under the conditions described in the notification (or the package labeling),” according to Matos.
The FDA also pointed to Phoenix’s ridiculous use of a clinical trial on terminal cancer patients to claim product safety.
“Furthermore, studies performed in advanced cancer patients generally cannot establish the safety of your ingredient in its intended population of normal healthy adults, and you did not provide any information to indicate that such extrapolation between different populations would be scientifically valid,” Abdel-Rahman added.
However you choose to package it, and whatever your motivation may be, Oleander 4x remains an untested and dangerous drug that needs to be removed from the public sphere with all haste.