The pandemic has sucked, which isn’t really news to anyone. But if you’re anything like the rest of the EG team, you’ve been looking for any silver lining to this whole experience of having to be cooped up at home and without outlets for socialization etc.
One of the few benefits from this whole global viral pandemic has been to really expose all the details intrinsic to the pharmaceutical industry: the good, the bad, and the technical.
The Good
Even though there was a clear personal profit-motivated reason, the industry had an unprecedented and cohesive response to COVID-19, with all hands on deck pivoting to contribute to vaccine research, MRNA tech advancement, or any kind of application of data to figure out innovative ways in disease prevention. The success of that kind of effort was such that we’ve developed new irrational vaccine fears!
(that is, if anyone around you starts babbling about how it’s too fast to develop a vaccine and it must be ‘fake news’ – consider: we haven’t had a global pandemic this virulent since 1918. Tech has advanced a lot since then. MRNA research itself has been a decade in the making. Is it any surprise that vaccine research has been able to piggy back off all that advancement to shorten its development time? Just take the vaccine when you can get it, damn it)
Furthermore, this is an industry that is notorious for being mired in paperwork and ridiculously-similar-trials-because-they-won’t-share-data, and that’s before we go through governmental agency approvals – you have to be impressed by the sheer speed and detailed analysis that all the vaccines have gone through. Even if it was backed by an equally impressive and unprecedented billions of dollars of government funding.
In the end, this industry that prides itself on monoliths making individual progress, banded together for the common good to collaborate between international companies, labs and research centres, to stand on one another’s shoulders to find solutions.
In other words, when push comes to shove – they’re all willing to play nice. That’s a relief.
The Bad
Even with all that optimism though, the industry has shown its Mr. Hyde.
Many companies have put out deliberately deceptive news about their progress in order to boost share prices and take advantage of retail investors. It’s become increasingly apparent the inability of shareholders to make an appropriate analysis of the technical details behind lab trials and med-talk – resulting in the ugly impact of unscrupulous companies taking advantage, and revealing a rotten issue at the core of medical informed consent.
It’s not just companies and vaccine development though: as politicians begin to discuss the roll-out of vaccines, we’re seeing more and more grandiose displays of ignorance, as political lines and values take precedence over proper data-driven and scientific approaches to an effective pandemic response.
If companies are driven by their bottom lines – politicians and their parties are driven by election results. Those motivations haven’t changed, and it’s been more than obvious that those motivations take precedence over the priority of a protected society.
The Technical
Ok, so however we got there, we’re there now: we have a decent variety of antibody treatments and vaccines. Given we were lamenting the fact that the average investor doesn’t have the experience to recognize what’s critical in intentionally vague lab reports, let’s fix that, shall we?
We will be breaking down the evolution of COVID-19 antiviral treatments other than the Moderna and Pfizer vaccines.
Remdesivir
The Gilead antiviral, marketed under the name Veklury.
On October 22, 2020, the US Food and Drug Administration (FDA) granted the drug full approval for the treatment of COVID-19 patients requiring hospitalization. The antiviral drug had been given emergency use authorization (EUA) in the spring, and is perhaps best known as being part of the confusing cocktail of drugs that Trump received in his COVID treatment.
Despite its use on the then-American president, Remdesivir has not been without controversy, with the WHO giving a conditional recommendation against the use of Remdesivir in November 2020, a mere month after the FDA’s full approval.
It’s therefore no surprise that there’s been a lot of conflicting reports about how effective the drug actually is, when it comes to helping COVID-19 patients.
Things get even murkier when you learn that:
- Gilead has set a price of $3,120 for a course of treatment for private insurers, and $2,340 for government payers.
- The US government invested $70M in the drug, and sponsored the only major trial comparing it to a placebo. (bear in mind, $70M is only a fraction of the $10B spending from Operation Warpspeed)
- In terms of rate of return: Veklury brought in $873M in revenue in Q3, the first full quarter it was on the market. Wall street analysts project that by 2022, sales could hit $7.7B.
If Gilead were to rescind its orphan drug designation and price remdesivir at $1/dose, it would still be selling at a reasonable profit (Public Citizen) – and at its current selling price of $52/dose, the profits are astronomical.
All of this, despite the Financial Times reporting on a WHO trial evaluating remdesivir and three other drugs in 11,266 hospitalized COVID-19 patients, only to find out that none of the drugs decreased the need to ventilate patients, nor affected hospital stays.
In fact, “[t]hese remdesivir, hydroxychloroquine, lopinavir and interferon regimens appeared to have little effect on in-hospital mortality”.
And that’s just the WHO’s research on remdesivir. If you dig deeper, there are even more blatantly credible reports casting severe doubt on the use of remdesivir.
This obviously isn’t intended to cast doubt on the COVID-19 treatments as a whole, but rather a reminder to always look into what international health agencies are saying (and maybe not just US government officials).
We remind you that “Gilead Sciences, the drugmaker behind the experimental COVID-19 treatment remdesivir, spent more on lobbying Congress and the https://e4njohordzs.exactdn.com/wp-content/uploads/2021/10/tnw8sVO3j-2.pngistration in the first quarter of 2020 than it ever has before, according to federal filings.
Take in the fact that “[Gilead] spent $2.45 million on lobbying in the first three months of the year, a 32% increase over the $1.86 million it spent in the first quarter of 2019” and consider if that has anything to do with the fact that there was more of a push for Remdesivir to get approved than other drugs.
Ivermectin
Ivermectin is the wonder drug that was discovered in late 1979 in Japan, as a dihydro derivative of avermectin. While it was originally introduced as a veterinary drug, its ability to kill a wide range of parasites in commercial livestock and companion animals quickly drew global interest in using it to combat tropical diseases in humans, resulting in an immeasurably beneficial impact in improving the lives and welfare of billions of people around the world.
New uses for it has continually been found as time wore on, and the off-patent drug has become even more popular for what some studies have shown as its ability to combat COVID-19, becoming the go to drug for various countries across the globe, especially South and Central America.
Ivermectin doesn’t come without its issues, but certainly without the blatant conflicts of interest of remdesivir. Approved by the FDA for treatment of onchocerciasis and strongyloidiasis, it nonetheless doesn’t have any major pharma companies lobbying for its use.
Instead, a group known as the Frontline COVID-19 Critical Care Alliance (FLCCC), led by three physicians, posted their meta-analysis of global ivermectin literature on its website.
These FLCCC doctors held a press conference in early December 2020, and one testified at a Senate hearing on early treatments for COVID-19, maintaining that ivermectin has a special combination of anti-viral and anti-inflammatory properties making it useful preventatively and for treating early and late-stage illness.
In turn, we’ve seen headlines noting a state Supreme Court judge ordering it as an experimental COVID treatment for an intensive care senior patient, acknowledging that it’s been touted as an alternative treatment – though not approved as such by the FDA or NIH as of yet.
Effectively, the consensus is still that more results are needed before the FDA will consider an approval for ivermectin as a COVID-19 treatment – and trials to that end are already under way, such as at Oxford University. The goal is to find treatments that could be used at home, shortly after symptoms appear, with the intent of catching the disease early and prior to serious health effects.
While there’s significant interest in the potential of ivermectin, these trials have all been limited by two major concerns.
- Ivermectin’s promise has led to a shortage of the drug.
- To further compound the stock problem, the drug itself has difficulty with solubility, and therefore the efficacy of its absorption. This means that ivermectin users are https://e4njohordzs.exactdn.com/wp-content/uploads/2021/10/tnw8sVO3j-2.pngistering more ivermectin that should strictly be necessary if the solubility issue could be resolved.
This brings us to the interesting market phenomenon of the day. Mountain Valley MD Holdings (CNSX:MVMD) has seen its share price rise from CAD$0.53 to $1.30 in a mere 5 days, with a 26% increase in the day so far.
First watch this Clip of our very own Jody Vance interviewing Dennis Hancock, President and CEO of MVMD:
and now on to, Why?
“TORONTO, ON – January 27, 2021 – Mountain Valley MD Holdings Inc. (the “Company” or “MVMD”) (CSE: MVMD) (FRA:20MP) is pleased to announce it has executed an agreement to conduct its Bio Safety Level 4 (“BSL-4”) lab study of COVID19 viral clearance in transgenic mice designed to prove the superiority of the Company’s solubilized Ivermectin technology versus commercially available oral form in speed and efficacy of viral clearance. The agreement was signed January 26, 2021. “This is a very significant project for MVMD and it will clearly demonstrate how our solubility technology applied to the Ivermectin drug can be applied as a broad therapeutic to immediately treat COVID-19, as well as its role in stopping the deadly spread of future pandemics that are certain to follow,” stated Dennis Hancock, President and CEO of Mountain Valley MD. “Quicksol™ allows us to imagine a world’s first as an injectable Ivermectin format for emergency front line usage as well as a rapid dissolve tablet that is https://e4njohordzs.exactdn.com/wp-content/uploads/2021/10/tnw8sVO3j-2.pngistered for prevention like vitamin C around the world.”
MVMD has reported a patented improvement for the impact of ivermectin by several magnitude, with 500% and 600% increases in the drug’s key performance metrics (including solubility and by that measure, efficiency of absorption). Beyond the massive market opportunity for the Company in COVID-19 treatment – this patented method to improve solubility stands to have critical and globally beneficial impacts.
MVMD’s progress relies on their patented solubility delivery solution Quicksol (™), a focus on traditionally highly insoluble drugs strictly guided by its stellar management team.
In other words, Quicksol makes it easier for drugs to be absorbed by the body system – this means you need to take fewer drugs, because the rate of absorption is higher. Since all medication has risks, this significantly reduces patients’ chances at variable results, or overdose – and the pressure on the world’s supply of ivermectin is reduced as well.
(In more technical terms: bioavailability indicates the degree and rate at which a drug is absorbed into the body. Poor drug solubility causes low bioavailability, decreasing a drug’s efficacy.
Poorly soluble drugs need higher doses in order to reach the optimal therapeutic levels needed for treatments. This can lead to problems such as gastrointestinal mucosal toxicity, affecting the membrane that lines many body cavities and covers the surface of internal organs for their protection.)
The Quicksol solution is huge for a large number of drugs, not just ivermectin. The issue of solubility is widely acknowledged in the field of pharmaceuticals as one of the core problems.
To bring it all full circle – consider: if the drug isn’t efficient unless in high doses because of solubility problems, this means that a pharma company needs to devote a certain amount of resources to provide the necessary stock. Higher costs makes it unappealing to the pharma company’s costs, and their patients’ wallets. Furthermore, the higher the dose, the higher the risk of side effects – which makes pharma companies’ insurance providers uncomfortable. This all reduces the chances of pharma companies even beginning to invest in trials, let alone the effort of bringing an otherwise beneficial drug to market.
And that’s all before we take into account the actual medical effect of patients having to take a higher dosage just for it to work.
It doesn’t take a medical degree to recognize that this patented delivery system of MVMD’s could be revolutionary in bringing more drugs to market, and improving treatments worldwide – and not just for COVID-19.
It’s no surprise that MVMD’s stock is rising so quickly in response to their news.
Final notes:
So much enthusiasm is coming from MVMD’s world class patented Ivermectin delivery method and its implications for treatment of COVID-19, however I cannot stress enough that Mountain Valley MD has a lot more to offer. The company is established based on impressive and innovative technology to deliver drugs/vaccines around the world in a manner that not only has scientific and monetary values, but also helps save lives.
