Many years ago, I was prescribed a drug by a physician assistant I saw because Stanford Health bait-and-switched her for my specialist. When I asked about the drug’s risks and side effects, she cavalierly assured me the drug was widely used and incredibly safe. As I don’t view PAs as MD equivalents and I distrust drug companies, I did some research and consulted with my primary care physician.
Turns out, my instincts were correct. While the drug was deemed safe for most users, in a very small cohort it triggered a virulent and deadly cancer. I chose to not rely on Lady Luck that I wouldn’t land in the unfortunate cohort. The FDA has since slapped a host of warnings on the drug, and a watchdog publication I subscribe to months ago recommended the drug be avoided altogether.
When it comes to understanding science, I am not that smart. Indeed, if they had a special bus for the science challenged when I attended grade school, I would have ridden it. But I have good instincts, and I prefer to understand potential risks, even if I’m unable to comprehend the technical reasons behind them. My common sense often compensates for the limitations of my intelligence.
Until this week, I was prepared to trust the Biden Administration and U.S. regulatory agencies to do the right thing and manage the pandemic without political and business considerations. It’s in my Canadian DNA to trust authority. What also fostered confidence for me was that Israel had made a bet-the-kibbutz decision and inoculated nearly the entire country with the Pfizer vaccine. My Hebrew school teachers inculcated me with the belief that Israel’s leaders more than any country were committed to acting in the best interests of their citizens.
The Biden Administration on Wednesday demonstrated that it is making critical vaccine decisions based on short-term political considerations. The New York Times later in the day posted an article that bust my bubble about Israel.
The Times story was about how badly Israel, the world’s most vaccinated country, is faring with Covid. The daily rate of confirmed new virus cases has more than doubled in the last two weeks and deaths are on the rise, including 230 so far this month. Vaccinated people were among those who died. Buried in the Times’ story was this glossed over detail: “. . . some Israeli data suggests the possibility of an increased risk of severe disease (emphasis mine) among those who received early vaccinations.”
I reached out to a physician contact, one that has been repeatedly censored for expressing concerns about vaccine safety, if he was familiar with the data the reporter was referring to. He said it’s a safety concern known as antibody dependent enhancement (ADE), and he sent me a paper posted on the National Library of Medicine’s website two weeks ago warning that vaccine boosters could trigger increased risk for severe COVID disease rather than reduce it.
My science challenged brain can’t understand the technical details of the paper, but there are a few words in sequence I can comprehend: “Antibody dependent enhancement (ADE) of infection is a safety concern for vaccine strategies.” I understand this too: “ADE may be a concern for people receiving vaccines based on the original Wuhan strain spike sequence (either mRNA or viral vectors). Under these circumstances, second generation vaccines with spike protein formulations lacking structurally-conserved ADE-related epitopes should be considered.”
I know the COVID vaccines are based on the original Wuhan strain, and while I have no clue about “structurally-conserved ADE-related epitopes,” I’d welcome knowing if the authors’ recommendations are being heeded, and if not, why.
The authors, Nouara Yahi, Henri Chahinian, and Jacques Fantini, are professors of Biochemistry and Molecular Biology at Aix-Marseille University (Chahinian is ranked among the top three percent of published authors worldwide on the Coronavirus). They aren’t the first to warn about the potential for vaccines to trigger more severe diseases. Four scientists published a similar warning in Nature Microbiology in September of last year.
Again, I lack the expertise and smarts to evaluate scientific papers on microbiology. But common sense suggests that if Israel has data suggesting the vaccinated are possibly coming down with more severe diseases and there are at least two scientific papers warning this could happen, it might not be the best idea to recommend booster vaccines for an entire country, which Israel is already doing.
What I learned from the Times story is the Israeli government isn’t above politics when it comes to pandemic decisions. The chairman of the expert panel that advises the Israeli government on its Covid response is a guy named Ran Balicer, who’s obviously a pretty smart dude. He has an MD and a Public Health degree and he’s Director of Health Policy Planning at Clalit, Israel’s largest healthcare organization.
How smart is Balicer? He co-authored a paper in May warning that vaccines alone wouldn’t eliminate Covid and that it was premature to remove other restrictions like indoor masks, quarantining, and vaccination certificates. Israeli leaders ignored Balicer’s warning, apparently because Israelis, like Americans, have lost their tolerance for lockdowns and other extreme measures.
According to the Times, Prime Minister Naftali Bennett, who assumed office in May, rose to power partly on the strength of his manifesto, “How to Beat a Pandemic.” Sounds a lot like a certain president who declared when he was running for office, “I’m never going to raise the white flag and surrender. We’re going to beat this virus. We’re going to get it under control, I promise you.”
What I want to understand is why Israel is doubling down on its vaccine strategy when it has data showing that boosters could possibly cause more harm. I’m also concerned about the secret details contained in Israel’s contract with Pfizer, particularly as the agreement was negotiated by former prime minister Benjamin Netanyahu, who was indicted on charges including breach of trust, accepting bribes, and fraud. Though the contract was made public, portions were redacted and will remain under seal for 30 years. A corrupt politician cutting a secret deal with a pharmaceutical company that agreed to the largest health care fraud settlement in U.S. history. What could possibly be wrong with that?
Dr. Robert Malone, whose bio says he is the inventor of mRNA vaccines, claims an Israeli scientist told him the country’s Pfizer agreement prevents disclosure of adverse events for 10 years. As I’m trying to be as balanced as possible, be aware that the Atlantic published a critical profile of Malone, as it did on Alex Berenson, a former New York Times reporter who like Malone is critical of the corporate media’s vaccine safety narrative. Also be aware that when the Atlantic hired a conservative writer from the National Review, readers and supporters rebelled and the writer was quickly forced out.
My concern the Biden Administration was playing politics when it announced Wednesday that it plans to make booster vaccines available in September, pending FDA approval, was reaffirmed by this story in Kaiser Health News headlined, “’We Sent A Terrible Message’: Scientists Say Biden Jumped The Gun With Vaccine Booster Plan.” The story quotes multiple experts on the record warning that vaccine boosters are potentially harmful.
The booster announcement was akin to disclosing a military strategy plan pending Pentagon approval. The Biden Administration, looking to distract from its Afghanistan debacle, made it seem that FDA approval is a done deal, and the agency is merely going through the motions to give the appearance that its carefully considering all the available data. It would be nice to believe the FDA is independent of politics and its decisions are based entirely on science.
That hope was shattered Thursday when Bloomberg disseminated a Biden Administration leak that acting FDA chief Janet Woodcock won’t be nominated as the agency’s permanent head. Under Woodcock’s watch, the FDA gave accelerated approval of an Alzheimer’s drug that an advisory panel opposed. I can’t tell if Woodcock is overly cozy with Big Pharma or that she’s being made the fall person for decisions she couldn’t control or was pressured to make. Woodcock has asked the Inspector General overseeing the FDA to investigate agency doctors involved in the controversial Alzheimer’s drug decision, which suggests that she welcomes an independent hearing.
Woodcock, 72, has been with the FDA for 35 years. According to Woodcock’s official bio, she has led many of the FDA’s drug initiatives, including the concept of risk management as a new approach to drug safety. Seems like valuable experience for evaluating a vaccine that was rushed to market under “warp speed.” Unlike a legion of other FDA officials who joined pharmaceutical companies after managing their drug reviews, Woodcock’s lengthy FDA tenure suggests she’s a committed public servant. Regardless, the agency responsible for one of the most critical health decisions in modern times has a lame duck leader.
What was reckless about the Biden Administration’s booster announcement is that it gave the public a false sense of security that the risks had already been carefully evaluated and deemed acceptable. I know of three individuals planning trips who were motivated to get the booster even without FDA approval. Their rationale is a take on an old Brylcreem hair gel commercial: A little jab’ll do ya. I’m possibly mistaken, but the science behind vaccines is a little more complicated than hair cream.
Pfizer reportedly has tens of thousands of vaccine doses set to expire, so I’m doubtful the government will take any measures against doctors or clinics who choose to prematurely administer the booster shots. Sadly, I’ve become that cynical.
Invariably, whenever there have been disasters or tragedies of epic proportions there was someone who had the prescience to see them unfolding and bravely sounded the alarm. I’m increasingly mindful about the dire vaccine predictions of Dr. Peter McCullough, who prior to the pandemic was widely regarded as one of the preeminent cardiologists in the world. McCullough has warned that massive Covid vaccination “will go down as one of the most deadly, one of the most injurious and costly in human history.”
Time will tell. But if McCullough is proven correct, I hope the censors who tried silencing him, the institutions who tried intimidating him, and the doctors who believed he was right but were too frightened to defend him will be held accountable.
In the meantime, I’d like to know about Israel’s ADE data so I can make my own common sense decision about vaccine safety and risks.