As someone who graduated from Harvard magna cum laude in biochemistry, who was primary author of a medical journal article on the use of an adenoviral vector (like certain COVID-19 vaccines), and who made millions of dollars on Wall Street on his ability to be on the right side of health care issues, I have been absolutely appalled by the information coming from all directions the last year and a half on this pandemic.
One of the things you have to be able to do to be very successful on Wall Street is to look at things very unemotionally and be brutally honest with yourself on the state of reality. There are a lot of people who struggle to do this. That is why often people with the best medical contacts have the absolute worst stock picking and timing decisions. There are times you need to not fight the crowd, even if you know they are wrong, and there are times you have to be the only person in the room who sees what is going on and put your money where your mouth is.
I feel my main strength was my ability to think completely independently and be objective like this. My business partner once asked me “Why makes you think you know better than all these doctors saying the Pfizer CTEP inhibitor will work?” after speaking with one of our highly distinguished medical advisors. I replied, “The science makes no sense, and we know from data in Japan that people with the mutation in the CTEP gene do not receive any cardio-protective benefit.” We were short Pfizer the day that Pfizer made the Phase III trials public, and I was proven right.
I am certainly not always right; none of us are. But I know how to think independent of the crowd and make intellectually consistent decisions most of the time.
That is not what I am seeing from people now. Pro vaccine medical authorities are spreading all sorts of provably wrong medical information, and I do not think they realize it is only making anti-vaccine advocates distrust them any more. At the same time, I see that exact same thing from the anti-vaccine people with some even crazier baseless claims.
Some of this information were made by established medical professionals that should know better. The problem is that most people have no idea how to read an FDA document or clinical trial and understand them. I suspect the doctor in the video I saw did not understand the legal differences between a BLA and an EUA and made some false assumptions, but all he had to do is look at the last page of the BLA and it would have blown his theory out of the water.
Everyone is so highly polarized that I can find few voices that are objective, particularly when it comes to real fact checking. Most “fact checkers” only address opposing viewpoints and do not touch those they are ideologically aligned with. So there is an overwhelming need to find some place to correct blatant misinformation on both sides.
This has been the case for awhile, and it just drove me nuts for the longest time; however, two events over the last week have pushed me to write this blog.
The first was my parents were being heavily pressured by their cardiologist to get the vaccine. I am adamantly against anyone taking the vaccine, based on the science and the data we have. As I will discuss in another article, based on Pfizer’s 6-month clinical data there is a 41.6% greater rate of having an adverse SEVERE outcome when you take the vaccine compared to placebo. This takes into account severe COVID-19 prevention, and the difference is highly statistically significant. This data was also hidden from Pfizer’s recent BLA label. That is not to mention all my other concerns like pathogenic priming that my parents were well aware of.
Luckily, we had enough conversations about this that they held their ground. They knew I had looked at the data backwards and forwards. I had warned my parents about taking COX-2 inhibitors when I saw the original Bextra FDA medical review document in November 2001, three years before the general public knew of the stroke risk. We had also witnessed enough medical malpractice and incompetence in our family to know to never trust any doctor fully. But this was one of the best doctors they had, which made his absolute insistence, and what I consider to be medical malpractice (no doctor should ever be aggressively pushing an experimental EUA therapeutic), very disturbing.
My dad is also on anticoagulants, and his cardiologist was apparently unaware that on the original UK label for the Pfizer vaccine there was a warning against giving it to people on anticoagulants (the myocarditis risk was mentioned back in December 2020 on the same label as well). You would think if the UK medical authorities or Pfizer itself had these concerns, the FDA might want to inform US physicians of those same concerns. Indeed if you search through the FDA VRBPAC panel document for “myocarditis” you will only find it on page 47 and not in the context of an identified known risk of the vaccine.
Source: Section 4.4 Special warnings and precautions for use, Page 6, REG 174 INFORMATION FOR UK HEALTHCARE PROFESSIONALS
There are a lot of good physicians who are just misinformed because most do not know how to think independently and evaluate clinical data. Heck, most physicians do not even have the time to do it. They rely on thought leaders who often have received a lot of money from large pharmaceuticals over their careers. And, if they hear all sorts of stories like the SARS-CoV2 virus never being isolated (it has…it took less than a few seconds to find studies in Pubmed), it is not surprising that doctors would dismiss any “antivaxxers” out of hand.
So there is a need for someone to present the case based on an evidence based medicine standard that doctors are supposed to value. Numbers from the company’s own clinical trials don’t lie. Well, sometimes they do, as I am about to disclose :). My point is, if numbers from a company’s own study justify not taking their own product, then you have no reason to believe a company like Pfizer would present their product in the worst case possible.
So I am setting out to address this need with some math that no one seems to be talking about.
The second reason is perhaps more serious. I saw a quite obvious flaw in the Pfizer 6-month data when it was released 6-months ago. You might not have caught it if you had not studied the FDA panel presentation data from December 2020 closely, but it was very obvious if you had. I was curious to see if the FDA would catch it.
There have been all sorts of allegations that there was political pressure being put on the FDA to rubber stamp this BLA in order to force some sort of dystopian Nazi/USSR/666 vaccine passport system. After all, you cannot force people to take an experimental drug. I determined that looking at the label to see if the FDA caught the obvious error would be a telltale sign that the game was rigged and the FDA data was literally just rubber stamped.
Well, much to my shock, when I was pouring through the BLA label on Monday, the blatantly false data was included on the label! It just floored me. There is supposed to be a whole team at the FDA looking at this. The error literally hits you in the face if you look at the data carefully. I honestly cannot believe anyone double checked the data. And if the FDA did not scrutinize a predefined secondary endpoint for accuracy, none of the other data can be trusted to be unbiased or accurate. We now need a truly independent set of eyes to review and validate the raw data. The FDA has lost what little credibility it had left.
Most likely, we are getting the most positive positioning of the data possible. And from years of watching drug companies massage data, I have seen every trick in the book. I have no confidence that there was no bias in grading adverse events, when that is inherently subjective. Severe adverse events could have been systemically underclassified as moderate. Serious adverse events could have been systemically classified as severe. We have to suspect the worse if the FDA allowed a death of someone with COVID-19 to be deemed not a severe COVID-19 case in the vaccine arm to lower the severe COVID-19 rate. And that is exactly what happened as I will prove in another article on this blog.
I expected to hear someone catch this error. Instead I have seen more talk about BLAs for “vaccines you could not get.” I am a very private person who really does not even understand why people spend time using social media outside of selling products. If people had seen some of that data that Facebook had on them that I have seen (and no, it is not stuff you have told them; it is data they bought from financial service providers and match with your profile details) very few other people would post anything to these platforms. I rarely even carry a cellphone, and when I have to, it is a flip phone.
But I feel I have a moral obligation to speak up now as I think this is a smoking gun that this BLA was rubber stamped and people should continue to treat it as a experimental medication.
As a result I will be addressing these issues in details with proof in subsequent posts.
I have been writing rapidly the past couple days trying to get as much information up as possible given how important I think it is that people know this BLA was not given a proper review. Please forgive any grammatical errors or other mistakes as I am just focused on getting this stuff up right now.