This compound, oleandrin, which is being pushed as a possible cure for COVID-19, is a microcosm of the many things that are wrong with the supplement and alternative medicine industries. This particular snake oil has some urgency because it is being promoted to president Trump. As Axios reports:
The experimental botanical extract, oleandrin, was promoted to Trump during an Oval Office meeting in July. It’s embraced by Housing and Urban Development Secretary Ben Carson and MyPillow founder and CEO Mike Lindell, a big Trump backer, who recently took a financial stake in the company that develops the product.
Lindell told Axios that in the meeting, Trump “basically said: …’The FDA should be approving it.'”
This is a new twist on an old scam. The pattern, as we have reported previously, is now well-established. A CAM entrepreneur secures a supply of an obscure natural product that has little to no current market value. Once they have essentially cornered the market they then promote the useless product as an exotic natural cure for whatever. They do this through the usual channels, but the holy grail is to get exposure through a CAM celebrity, like Dr. Oz. Once Dr. Oz features your product on his show, you rake in the snake oil lucre.
That appears to be what is happening with oleandrin, except the celebrity snake oil peddler is the president. He has a lot of influence on his followers, and perhaps even some influence with the FDA to boot. Look what happened with hydroxychloroquine.
Oleandrin displays another feature of the CAM industry, or currently dysfunctional regulations. Specifically, this deals with the giant hole blown in the FDA’s ability to protect the public from snake oil known as DSHEA (The Dietary Supplement Health and Education Act of 1994). This was a gift to the supplement industry, creating a new category of health product that could make quasi-medical claims without any evidence of safety or effectiveness. It essentially allows supplements to be regulated more like food while making or implying medical claims.
Lindell is now trying to drive oleandrin through this hole:
The first path is as a COVID-19 drug, which would involve a rigorous process that includes clinical trials.
But to hedge his bets, Whitney said he is also pushing the FDA to allow oleandrin to be sold off the shelf as a dietary supplement — a move that could be made immediately, Whitney has told administration officials. [Andrew Whitney is from Phoenix Biotechnology, the company making oleandrin – SN]
This strategy reveals the absurdity of the regulation, and how easily it is abused. Oleandrin is clearly a drug, but Whitney will try to get it categorized as a dietary supplement to essentially bypass FDA requirements for scientific evidence of safety and efficacy. As long as you don’t name a disease in the promotion, this powerful drug is magically a “supplement”. This shows how the category exists only to bypass the FDA. It is not a real science-based category at all – it’s a regulatory fiction. (True supplements are vitamins and minerals, not herbal drugs or any other “natural” drug.)
This episode also reveals the dangers of mixing politics and science. Politicians should not be meddling in the details of scientific organizations, like the FDA. The FDA should be completely independent, using scientific evidence to fulfill its mandate. When political priorities intrude on questions that should be purely based on scientific evidence, bad science and bad regulations result.
Let’s take a look at oleandrin specifically to see where we are with the science. Oleandrin is a chemical derived from the plant, oleandra (Nerium oleander). 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. It is a beautiful Mediterranean plant used around the world for landscaping. Every part of the plant is poisonous, containing the powerful cardiac toxin, oleandrin. This can lead to cardiac arrhythmias and can be fatal.
The science made public so far is a single pre-clinical study, showing that oleandrin has anti-viral activity against SARS-CoV-2 in a test tube (the study is pre-print and has not been peer-reviewed). That’s it. This is another common feature of the snake oil industry – tout products based upon preclinical data only. This kind of data may seem promising, and allows snake oil peddlers to claim their products are backed by scientific studies. But this kind of in-vitro study tells us very little about the activity of potential drugs in living organisms. Very, very few compounds that have “promising” activity in vitro go on to become useful medicinals.
Among the many potential problems include what we call pharmacodynamics and pharmacokinetics. How is the substance absorbed, where does it go in the body, how is it metabolized and eliminated, and how long does it last? Any one of these factors can be a deal-breaker.
But even more important – what are the dose-specific desirable effects, side effects, and toxicities? In order for a drug to be useful there needs to be a sufficient dose range in which beneficial medical effects can be achieved without significant side effects or toxic damage to any organ. Again, many promising drugs fail because they cause kidney or liver damage – or fatal cardiac arrhythmias. In fact, it’s easy to find substances which kill viruses or bacteria in the petri dish. Many poisons (or bullets) will do this. The trick is to find substances that will inhibit or kill the virus at doses lower that those that cause toxicity to human cells.
Showing potentially useful activity in vitro is just the first step to finding a useful drug. It is not a very impressive step, as most such substances will eventually fail later research. We need more than one in vitro study to understand the potential harms and benefits of the drug. If it is still looking promising (unlikely but possible) then we need to do animal testing for both safety and possible effectiveness. If it survives animal testing (also unlikely) then we can proceed to preliminary human testing, just making sure it is safe and learning about how humans process the drug and how the drug affects humans. If the drug is looking safe in humans (phase 1 studies) then we can do preliminary efficacy trials, with further safety testing (phase 2). Then and only then can we do definitive double blind placebo controlled efficacy trials (phase 3).
Putative drugs fail every step along the way in this scientific gauntlet. Most drugs fail because of toxicity, and many more because they simply don’t work in a safe dose range. Often during the preliminary development stage, pharmaceutical companies have to tweak the chemical structure of naturally-occurring chemicals in order to give them any chance of being a useful drug.
To take a raw plant-based powerful poison, and promote based upon a single pre-print in-vitro study is scientifically absurd and morally horrible. To do so in the middle of a pandemic is nothing short of malfeasance.