September 8, 2020
Of all the American Consequences contributors we’ve featured, only one is my go-to source for questions about the bleeding edges of medicine and technology…
- He attends more high-level medical conferences than most doctors. (I traveled with him to one last fall… we were the only financial-focused folks that I saw there. Practically everyone else was a doctor or a medical technologist.)
- He’s stood shoulder to shoulder with researchers who have cemented a place in medical history. From CEOs developing exclusive cancer treatments to academics who have saved hundreds of thousands of lives with their studies.
- He’s gone inside high-tech labs across the U.S. and Europe… behind the scenes in the research wings of Harvard, MIT, and Johns Hopkins… and even briefed the U.S. Congress.
Along the way, he’s uncovered a secret playbook for what really works and what doesn’t in medicine.
All this is in service of finding the biggest medical breakthroughs for Main Street investors… often before Wall Street and the financial media realize what’s really going on.
As you likely well know, once news hits headlines, the biggest opportunity for investors is typically over.
And this analyst’s track record is extraordinary. One of out every three stock recommendations he makes at least doubles in price.
In fact, he’s managed to pinpoint some of the most successful pharmaceutical companies of the past two decades – long before they were trading at their current valuations.
But this isn’t just rehashing old history. His track record this year alone is incredible.
In fact, his average result so far this year is a 193% gain. And that’s based on every single one of his closed recommendations – both winners and losers.
Nonetheless, I bet you don’t know his name…
You see, my good friend and mentor Dave Lashmet rarely writes for the public. And he even more rarely lets us write about him.
The last time we were able to get him in the pages of American Consequences was three years ago. Then, he wrote about the incredible opportunity in self-driving cars… and specifically pinpointed graphic-card technology titan Nvidia (NVDA).
If you had looked into Nvidia and added a few shares based on his American Consequences article, you’d be up more than 200% today.
Of course, his paid-up subscribers to his tech-focused letter, Stansberry Venture Technology, have profited far more. This summer, he recommended his subscribers lock in a 777% gain in Nvidia.
What’s even more astounding is that this wasn’t even his biggest win of 2020.
You see, earlier this year he recommended his readers lock in a 1,183% gain on a company in the race for a COVID-19 vaccine…
That’s the single-biggest gain in Stansberry Research history. And it came in less than 12 months.
To be fair, Dave didn’t predict this precise COVID-19 pandemic playing out exactly how it has when recommending the company. (Who could have known that?) But he did get close – and certainly laid out the threats from similar viruses and diseases.
Dave recommended the stock as a speculative play primarily because of its groundbreaking work in vaccines for highly contagious, viral illnesses. He even said, “We need this type of fast-acting vaccine for national security.”
All that to say that when Dave shares his insight, “in the know” folks listen.
And today, he’s making his biggest prediction yet…
He says one company’s world-changing drug is set to have the potential to cure one of the fastest-growing diseases in history. This disease will soon affect half of U.S. adults, according to NBC.
Nothing has been able to stop or slow this disease. It’s an epidemic that has burned through our country like wildfire.
Just look at this map:
And no, this map doesn’t show COVID-19. It’s far, far more dangerous. In fact, this disease leads to the death of 10 times as many Americans every year than the number who have died so far from COVID-19.
One drug has the power to stop this disease in its track. And if Dave is right, it could deliver 2,000% long-term upside for investors.
But only if you get in now. And the clock is ticking…
But please keep in mind that thanks to the COVID-19 pandemic, the success of this medical breakthrough is currently flying under the radar.
That won’t last.
As much as 70% of the population in the United States could be prescribed this drug if it were available tomorrow. And the Food and Drug Administration (“FDA”) is expected to rule any day now.
Dave believes that once the FDA makes its decision, the biggest opportunity will be gone…
That means the 2,000% potential gains you could see in the coming years – enough to turn every $5,000 investment into more than $100,000 – simply won’t wait around. To learn more, click here.
And below, read Dave’s piece that we’re thrilled to feature in our September issue. It’s so valuable that we simply couldn’t hold it for our magazine publish date in two weeks…
Publisher, American Consequences
The October Vaccine Surprise
Think a vaccine will be ready this autumn? Think again…
By Dave Lashmet
Expect a COVID-19 vaccine “October surprise” this election season…
So far, the COVID-19 pandemic has led to roughly 6 million U.S. infections, with a 2.5% case fatality rate. The contagion reaches across friends and family, spreading at an alarming pace.
A vaccine is thought of as an end point – a “way out” of this mess we’ve made. That may or may not be true… But both politically and for the sake of the economy, few are interested in waiting to see how effective the vaccine will be… just as long as we have one.
I’ve been a market analyst for 20 years, largely focused on medical advances, new drugs and treatments, and technology breakthroughs. And in my years of experience with the biotech space, I’ve seen what it takes for drugmakers and other companies to combat the worst threats to our health.
The global coronavirus pandemic is kicking several of these battles into high gear now. And that means investors need to know what’s happening in this part of the market… and what a vaccine really means.
You see, questions will remain this October…
Will the vaccine work? Maybe. Will it be painful? Potentially, yes, very much so. Will it be permanently harmful? Probably not.
So overall, any one of these vaccines is probably a better deal than getting COVID-19.
That’s all we know so far… And that’s all we will know next month, too.
Even in the face of the COVID-19 pandemic, pivotal trials for a vaccine take six months. We will have a large sample of people’s reactions to a first and second vaccination – most take two doses for full protection. However, that is not a proxy for effectiveness. A vaccine that wins early approval and later proves to be ineffective will burn the goodwill of the people – especially if this worthless vaccine came with side effects.
Nevertheless, you can expect an “emergency use authorization” by the FDA by October 20, 2020.
The reason behind this date is the “animal rule.”
This rule is the reason why drug companies can develop a vaccine for a lethal contagion without risking people’s lives… at least at first.
Some contagious infections are so lethal or difficult to treat that it would be unethical to test them on living volunteers. Instead, we use two stand-ins: non-human primates (generally monkeys or chimps) and one other kind of animal that gets the disease.
In part, this is why the U.S. government builds massive biocontainment labs: to run animal experiments while protecting the scientists.
The key experiment is called a challenge trial… You give the vaccine to the animals, then challenge them with the live virus. Ideally, you’d want the animals that got the vaccine to be fully protected and show no signs of sickness. Still, if the vaccinated animals get sick but have a less severe form of the disease, that’s helpful. For example, a sickness but not a fatal case.
Scientists also challenge another equal number of animals who don’t receive the vaccine. That proves the virus is live and lets researchers compare how both groups react.
From there, it’s a subtraction: how well did the vaccinated animals do compared with unvaccinated controls. That’s the protocol.
Researchers do try to look at side effects in the animals, too. But animals are hard to read. And they can’t report how they’re feeling. That’s how a vaccine can work well in animals, but still have significant questions when it comes to human side effects.
The U.S. Centers for Disease Control and Prevention (“CDC”) recently summarized the first 1.3 million U.S. cases of COVID-19. Of those cases, there were 72,000 deaths. For 40-year-olds, the CDC found a 1% risk of death from COVID-19. For 50-year-olds, the risk is 2%. For 60-year-olds, it’s 7%. For 70-year-olds, it’s 17%. And for the 80-plus bracket, there’s a 32% risk of death.
It’s easy to see that the older you are, the more at risk you are. And so far, COVID-19 therapies have been slow to roll out.
Still, we might see some of those get added on to an October vaccine surprise…
In particular, watch for specialized antibody drugs that are made in bioreactors but can be added to the veins of severely ill patients. These antibody drugs specifically target the virus that is causing COVID-19. The drugs start clinical trials in late summer and work fast. Indeed, if more patients improve when given antibodies versus a matching control group, you can see an antibody work within days.
So when the vaccine advisory committee of the FDA meets, knowing that there is an effective antibody drug will also help approve a vaccine. That’s because these antibody drugs are additional safety nets in case the COVID-19 vaccine is less effective in people than in animals.
The truth is that the translation from animals to people is never perfect. A good rule of thumb in biotech is that every drug candidate works in mice, but only 1% of them win FDA approval.
Still, knowing that there is an antibody drug – or a cocktail that includes a mix of antibody drugs – offers a promising safety net.
The U.S. and global biotech manufacturers are highly effective, overall. Given time, they can make powerful, safe, and effective drugs…
The problem with COVID-19 is that the epidemic moves so fast, we need to stop it quickly – so this is clipping off drug development time.
In sum, this explains why we can get a vaccine for COVID-19 approved by the U.S. FDA for emergency use by October 20, 2020.
But it leaves a major question unanswered: What are the side effects that someone would face when they get this vaccine?
See, when doctors talk side effects for vaccines, they are weighing the side effects against the disease the vaccine is designed to prevent.
For example, look at the newly approved Ebola vaccine…
Made by pharma giant Merck, it won FDA approval in December 2019. Ebola can have a case fatality rate of 50%… It kills quickly, and it spreads broadly. Compared with that, severe side effects are acceptable… 18% of vaccine recipients reported joint pain and 9% reported new arthritis symptoms from the vaccine. None of the controls reported any extra arthritis symptoms. So while these are serious side effects, they’re also better than dying.
For COVID-19, which is a lot less fatal in the aggregate – running at about a 2.5% case fatality rate – we can’t accept as high of a threshold for severe side effects.
And yet we are seeing serious side effects in some early-stage COVID-19 vaccine trials…
For example, drug developer Moderna reported that three of 15 patients in its Phase I trial reported serious adverse events requiring an emergency room visit at the highest dose. And although the dose has been lowered for the Phase III trials, that’s still a major warning sign about the safety of Moderna’s vaccine.
As for efficacy, we won’t have this data by October. Like I said, we will use the animal rule instead. Unfortunately, people can be a lot older or a lot more obese than lab animals.
Hopefully, any “October surprise” vaccine will take side effects into account…
But either way, with one major exception, this is going to be an opt-in vaccine. Even doctors and nurses will not have to take it. They can always change hospitals or professions.
However, soldiers don’t get that choice. So we expect the initial emergency use approval for a vaccine to largely apply to the young and healthy – focused on U.S. military personnel. After all, the Department of Defense needs FDA approval before vaccinating our troops. That’s to keep up with the Russian and Chinese militaries.
Finally, let’s talk distribution…
Military issues aside, the first folks eligible for a vaccine will be doctors, nurses, first responders like paramedics, and other medical aides in nursing homes and other care facilities.
These vaccinations can start by the end of 2020… but likely only with about half a million doses by then. The bulk of our health care workers won’t be protected until Spring 2021.
National distribution may start in the second quarter of 2021. But it might not finish until sometime in 2023. In other words, it’s unlikely that millions of Americans will be able to stop by their local Walgreens or CVS pharmacy and get a free COVID-19 vaccine this December.
The good news is that by the time a vaccine is available to you – say, sometime next summer – we will have strong evidence of its safety and efficacy.
The more sobering news is that until that time, you can expect local, state, and international mask mandates, since COVID-19 is an airborne, lethal contagion that especially threatens people over the age of 50.
In short, although we can approve a vaccine for its political importance, medically, we will know very little until the spring.
And nationally, it won’t protect us for another year, at least. Full distribution and herd immunity are at least two years away.
Bottom line, vaccinating 200 million Americans is possible… But it’s not fast, nor easy.
Now here are some of the stories we’re reading…
STAT COVID-19 Drugs & Vaccine Tracker
Here’s a guide to some of the most talked-about efforts to treat or prevent coronavirus infection, with details on the science, history, and timeline for each endeavor
Covid-19 Deaths Significantly Reduced by Use of Steroids, Analysis Says
Studies involving 1,700 patients showed consistent benefits from corticosteroid treatment, raising hopes that cheap drugs can help treat severe cases
Signs of depression have tripled in the U.S. since the COVID-19 pandemic got underway
In the weeks after the outbreak prompted quarantines and stay-at-home orders, 27.8% of those surveyed had at least one symptom of depression. That compares to just 8.5% of people in 2017 and 2018.
U.S. Debt Set to Exceed Size of the Economy Next Year, a First Since World War II
That would put the U.S. in the company of a handful of nations with debt loads that exceed their economies, including Japan, Italy and Greece.
The Oysters That Knew What Time It Was
The field of “chronobiology” has since exploded, with researchers uncovering intricate networks of molecular cogs and gears that keep time inside our cells, allowing virtually all creatures on this planet to anticipate the daily and seasonal movements of the sun. But there’s still a fundamental mystery at the heart of biological clocks that has never been explained.
And let us know what you’re reading at [email protected].
Publisher, American Consequences
With P.J. O’Rourke and the Editorial Staff
September 8, 2020