America’s Frontline Doctors anti-vaccine affidavit – expert analysis

America's Frontline doctors affidavit

This article, about America’s Frontline Doctors anonymous anti-vaccine affidavit, was written by Kelsey S Hollenback, a Ph.D. student in Systems & Information Engineering at the Center for Risk Management of Engineering Systems, Department of Engineering Systems and Environment, School of Engineering and Applied Sciences, University of Virginia.

On reviewing America’s Frontline Doctors anonymous affidavit, part of a recent lawsuit over the COVID-19 vaccines, my first and most important takeaway is that, while Jane Doe apparently wishes to assert that she has discovered excess mortality associated with COVID-19 vaccines, what she describes in her affidavit bears absolutely no resemblance to how to conduct an actual such analysis.  Not even a little bit.

My second takeaway, which almost doesn’t matter given the first, is that, insofar as it’s possible to determine the methodology she used from the extremely limited description provided, that methodology is…flawed. 

Flawed in what ways? It counted more deaths associated with a COVID-19 vaccine than there are total deaths recorded in VAERS. It doesn’t account for differences between the CMS patient population and the general population. Depending on what criteria Jane Doe used to query the CMS claims database, she may have pulled patients receiving any vaccine, not just the COVID-19 vaccine; she may have pulled only patients receiving Moderna, or only Pfizer, or only Johnson & Johnson; she may have failed to pull patients receiving a no-cost or government-provided vaccine; and/or she may have oversampled patients at higher risk generally for all-cause mortality.

My third and final takeaway is that, while America’s Frontline Doctors affidavit does not in any way describe either a valid method for identifying excess mortality associated with the COVID-19 vaccine, doesn’t do anything at all to establish causality, and certainly doesn’t expose any cover-up, it does possibly reveal a serious HIPAA violation.

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Drug development – explaining a complicated process, including vaccines

Based on some of the comments I see on the internet, I think that that people believe that drug development is easy. Anyone can do it. And all you have to do is invent a drug and, voila, it’s approved and you can make billions of dollars in gold

I might be over-exaggerating, but I’ve always thought that the anti-vaccine crowd believes in their heart that the development of vaccines includes throwing a bunch of stuff in a blender along with dollops of mercury, formaldehyde, aborted babies, and aluminum, which is poured into a vial and sold for billions of dollars. Despite those anti-vaccine myths, pharmaceutical drug development (including vaccines) is a difficult process that fails 99% of the time.

Drug and vaccine development is the total opposite of easy. It takes time, a lot of brilliant minds, and some luck. Sure, some worthless drugs do get approved (we’re eyeballing you Biogen), but almost every drug that fails to have a significant benefit to cost (in terms of safety and price) ratio will fail to get FDA approval.

The myths about drug development are filled with controversy, false claims, and conspiracy theories. Yes, occasionally, we can point out problems with the process. Unless you’re using confirmation bias, you will see that the vast majority of pharmaceuticals are very safe and very effective (or at least the benefits outweigh the risks).

One of the largest myths is that there really isn’t any regulation – Big Pharma owns the FDA (and other regulatory agencies) and does whatever it wants. But let’s look at the process of drug and vaccine development carefully, including how most drugs are investigated and brought to the market. Let’s try to separate the myths from the facts of pharmaceutical drug development.

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Guillain-Barré syndrome may be linked to the JNJ COVID-19 vaccine

Guillain-Barré syndrome

The US Food and Drug Administration (FDA) is warning that the Johnson and Johnson (JNJ) COVID-19 vaccine may be linked to Guillain-Barré syndrome, a relatively rare autoimmune disorder. Unfortunately for the confidence in the vaccine, this follows up on several other missteps and potential cardiovascular issues with the vaccine.

Nevertheless, it is clear that the COVID-19 vaccines’ benefits, preventing the disease, far exceed the extremely rare risks.

Because there is a lot of confusion about Guillain-Barré syndrome and whether there is a causal link to the JNJ vaccine, I will try to present the facts as they are known today. Of course, things change, and the CDC’s Advisory Committee on Immunization Practices (ACIP) will meet on 22 July 2021 to further discuss this issue, so stay tuned for more information.

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FDA approval of Alzheimer’s disease drug aducanumab – Inspector General may investigate

Alzheimer's disease drug

Last week, the US Food and Drug Administration (FDA) approved the first new drug, Aduhelm (aducanumab), for Alzheimer’s disease in 18 years. The new drug is manufactured by Biogen, a US-based pharmaceutical company, and if you read the news reports and social media posts, you’d think the new drug is a miracle.

Given that Alzheimer’s disease afflicts over six million Americans each year, we wanted to celebrate aducanumab as a miracle. Except, there’s really nothing to celebrate here.

The FDA ignored the advice of its own expert advisory committee, which voted overwhelmingly (eight against approval, one for, and two abstained) to not recommend the drug because, according to the FDA’s own analyses, the drug failed to show that it can do anything to treat Alzheimer’s devastating cognitive decline. Plus aducanumab costs $56,000 per year (yes, $56,000) and comes with a relatively high risk for brain swelling and bleeding.

In response to the outcry, Acting FDA Commissioner Janet Woodcock wrote a letter to the acting inspector general of the Department of Health and Human Services, acknowledging that there has been “significant attention and controversy” surrounding the approval of Aduhelm. In particular, Woodcock said, concerns continue to be raised about the agency’s contacts with Biogen, including “some that may have occurred outside of the formal correspondence process.”

So we have to ask why would the FDA approve this new drug for Alzheimer’s disease, even though aducanumab is expensive, has serious side effects, and probably doesn’t do anything to improve the outcomes of Alzheimer’s patients? And because the drug is so expensive and everyone will demand the drug for the disease, this could add hundreds of billions of dollars to the cost of healthcare in the USA and across the world (don’t believe for a second that this possibly worthless drug is going to cost only $5.00 in Denmark, because it won’t).

The answers to these questions are complicated, and I’ll try to explain. But I think what happened here is disturbing and tragic. And it could have implications for any new drug approved by the FDA.

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COVID vaccines effectiveness against new Delta variant

COVID vaccines effectiveness Delta

With the spread of the Delta variant (known as B.1.617.2 by the CDC) from India, scientists have been concerned about the effectiveness of COVID vaccines against it. The good news is that the Pfizer and AstraZeneca vaccines seem to fairly effective against this new variant of SARS-CoV-2 virus.

Let’s take a look at the paper that describes the effectiveness of the vaccines against the COVID-19 Delta variant.

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Myocarditis and COVID mRNA vaccines – very rare adverse event

myocarditis covid mRNA vaccines

Regulatory agencies, such as the FDA and CDC, are monitoring reports of myocarditis, a heart inflammation, after COVID-19 mRNA vaccines from Moderna and Pfizer. Although myocarditis after these vaccines are exceedingly rare, anti-vaccine activists have already jumped on this issue to make it appear that COVID-19 vaccines are dangerous.

My job is to look at this data and give you a scientific analysis of the observations and whether they are actually related to the vaccine.

Like with reports of other conditions, such as blood clots, after receiving COVID-19 vaccines, we need to examine whether myocarditis is actually related to the vaccine or just random events in which the incidence is no different than what would be predicted in a similar group of unvaccinated people. And if it is linked, we need to look at the potential risk and compare it to the risks of COVID-19 itself.

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COVID-19 vaccines and myocarditis – what are the facts

medical stethoscope and mask composed with red foiled chocolate hearts

Regulatory agencies, such as the FDA and CDC, are monitoring reports of myocarditis, a heart inflammation, after COVID-19 vaccines. Although if there is a link, it is exceedingly rare, anti-vaccine activists have already on this issue to make it appear that COVID-19 vaccines are dangerous.

My job is to look at this data and give you a scientific analysis of the observations and whether they are actually related to the vaccine.

Like with reports of other conditions, such as blood clots, after receiving COVID-19 vaccines, we need to examine whether myocarditis is actually related to the vaccine or just random events in which the incidence is no different than what would be predicted in a similar group of unvaccinated people. And if it is linked, we need to look at the potential risk and compare it to the risks of COVID-19 itself.

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Why can’t we get a cancer vaccine as fast as one for COVID-19?

cancer vaccine

I keep reading memes and other nonsense that if scientists are so smart why can’t we have a cancer vaccine as fast as we did for COVID-19? It’s not a serious question, it’s actually pejorative – it’s meant to imply that we’ve been looking for years for a cancer vaccine without success, yet we were able to get a COVID-19 vaccine within a few months, so obviously it was rushed.

Fortunately for us on the side of science, this is one of the silliest and most desperate myths being pushed by our favorite anti-vaxxers.

Busting cancer myths is one of my favorite activities – my non-statistical analysis of medical pseudoscience puts cancer slightly above vaccines on the stupidity of the tropes. Combining vaccine nonsense with cancer is right up my bailiwick. Let’s have some tearing apart this trope.

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COVID vaccine breakthrough infections – let’s do some simple math

Let’s talk about COVID-19 vaccine breakthrough infections. That is individuals who contract COVID-19 despite being fully vaccinated by the Pfizer, Moderna, or JNJ vaccines, the only ones with Emergency Use Authorizations in the USA.

This article is going to be short and, hopefully, sweet, because even though the number of COVID-19 vaccine breakthrough infections appear large, it really isn’t. It’s just simple math.

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Myocarditis and COVID vaccine – a rare event that may not be linked

COVID-19 vaccine myocarditis

Regulatory agencies across the world, including the FDA and CDC, are monitoring COVID-19 vaccine adverse events including reports of myocarditis, a heart inflammation. Of course, the anti-vaccine squad will probably jump on this to make it appear that the vaccine is dangerous.

My job is to look at this data and give you a scientific analysis of the observations and whether they are actually related to the vaccine.

Like with reports of other conditions, such as blood clots, after receiving COVID-19 vaccines, we need to examine whether this adverse event is related to the vaccine or just random events in which the incidence is no different than what would be predicted in a similar group of unvaccinated people.

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