The FDA’s Paxlovid Pandemonium
Back in August of 2022, I wrote a piece on Pfizer’s Paxlovid approval. I talked about how the White House awarded Pfizer billions of taxpayer dollars before producing conclusive findings of safety or efficacy to the FDA.
In approving Paxlovid, the Biden White House and the FDA also seemed to deliberately ignore hundreds of clinical trials conducted on hundreds of thousands of patients detailing the established safety and efficacy of IVM and HCQ.
Like many other things the Biden White House implements, they force through a multitude of ideas, concepts and public health mandates which “seem” like they could work, but without the requisite conclusive scientifically obtained evidence that they will work.
On top of that, the White House doesn’t seem interested in learning. They repeat their mistakes in establishing America’s policies time and time again. Emergencies or not; there is no excuse for foregoing the scientific method (or using poor testing methodologies) thereby placing the Americans at risk – especially when it comes to public health.
Paxlovid is just one of dozens of examples of public health mendacity (too many to list here) pushed by the chaotic Biden White House and its ethically pliant partisan marionettes at the FDA. In the case of Paxlovid, not only was evidence of failure deliberately ignored; prospective testing methodologies were altered mid-trial to favor a positive outcome when it became apparent that the Paxlovid trial results would not meet their original endpoints. In fact, Pfizer had already opted to stop its Paxlovid trial, but then changed their minds after the FDA intervened via the White House.
Even worse: Its not the first time the FDA has forsaken science under Biden (I warned this would be a repeating theme in early 2021). Paxlovid was a failure, but the White House had foolishly already paid Pfizer $5.3 Billion in advance. Rather than admit failure and epic waste, the FDA then stepped in and with zero transparency, altered the established clinical trial parameters mid-trial to make Paxlovid’s findings seem better than they were. Pfizer then completed the trial, declared Paxlovid a success and the White House doubled-down on its $5.3 Billion investment, spending a sickening total of $10.6 Billion on Paxlovid.
That moral and scientific decision was approved by America’s insufferable, self-righteous taxpayer-funded civil servants who proclaim the left is “the party of science” and celebrated that when Biden was elected, “the adults are back in charge.”
“Following the science” is their tired jingle, but not their actual policy.
Even more outrageous were the number of nurses, pharmacists and physicians who witnessed – and fully recognized the scientific misconduct – but remained (and continue to remain) silent, inexplicably choosing to follow clinical recommendations from politicians, bureaucratic hospital administrators, mainstream news or social media. It is impossible to overstate the cowardliness, conformism and malpractice of these professionals in betraying their oaths to protect patients.
In reality, Americans still don’t have answers form the White House, FDA or any other HHS officials on:
1) The White House’s logic of purchasing $10.6 Billion of Paxlovid, and without concrete evidence of safety and effectiveness;
2) How many unused Paxlovid doses remain that will ultimately expire and be thrown away due to non-use, milder disease making it epidemiologically unnecessary;
3) Disclosure of the real-world incidence of “rebound” Paxlovid infections (which would be hard for drug safety epidemiologists to uncover because the White House, Pfizer and FDA have every reason in the world to under-report it, plus “rebound” is not an official [MedDRA] adverse event reporting term);
4) The current/historical prescribing and rates and other Paxlovid adverse event updates;
5) A full disclosure of communications with Pfizer, the White House and FDA officials with a scientifically legitimate explanation of why altered critical parameters of the Paxlovid were made mid-trial and in lieu of starting a completely new trial;
6) An official pharmacologic, mechanistic explanation of “Paxlovid rebound” ;
7) Why the Paxlovid trial was compared to placebo only, and had no IVM / HCQ / other comparator arms.
The original article from August 2022 is reprinted below.
Shortly after President Joe Biden touted his recovery from Covid last week, he once again tested positive for the virus, in a rebound case that is often associated with the drug Paxlovid, which Biden was taking.
Countless Americans who have taken Pfizer’s Paxlovid following a Covid infection have experienced what everyone is calling “rebound Covid.” Rebound Covid is a recurrence of the virus that occurs in a person who has already recovered from Covid, many times shortly after completing Paxlovid.
What does it mean?
Clinical scientists are offering all kinds of different theories, but no definitive explanations for the “rebound” Paxlovid phenomenon. It’s a mystery and regardless of what it is, it can’t be good.
Why Make High-Risk Patients Sick Twice?
Rebound Covid post-Paxlovid raises a critical public health and drug safety concern. According to the NIH, only high-risk populations are supposed to get Paxlovid, but taking Paxlovid sometimes opens those same high-risk patients to a rebound infection with Covid. In some cases, the rebound Covid symptoms are worse, placing the same high-risk patients in more severe danger.
One doesn’t need to be an FDA expert to know that having high-risk patients get sick twice is worse than once.
Why is Biden still advocating for Paxlovid’s use, as recently as last week? Its because the White House doesn’t have a political option. It must either a) admit failure or b) ignore public health. The White House has foolishly chose to pay Pfizer $10.6 billion for Paxlovid, based on a highly preliminary “pilot study” showing nearly 90 percent effectiveness which later dissolved into its study failing and being voluntarily discontinued by Pfizer prior to its completion.
Paxlovid failed its trial endpoints when compared to a placebo group. Perhaps the Biden White House didn’t realize that informal preliminary pilot studies are never conclusive and “results” need confirmation with a formal clinical trial and account for variables like mutations. Regardless, the White House did not wait until the formal trial was complete before committing $10.6 billion in taxpayer dollars.
Spending Billions on a Questionable Drug
The White House’s actions are inexcusable. Not only do they refuse to acknowledge that the drug was a failure and that they had prematurely and inappropriately spent a vast fortune on something ineffective and potentially dangerous, but they continue to promote Paxlovid’s use!
Rather than protecting patients, the White House is choosing to sacrifice the well-being of at-risk patients.
The actual rate of Paxlovid rebound is hard to know. First, Americans were told it was “rare,” less than 1 percent. Then we were told it was 5.4 percent, then 10 percent. On July 30, 2022, one CNN medical analyst and professor at George Washington Universitystated that with the newest Covid strain it is “likely 20-40 percent or even higher.” Anecdotal reports from social media make it seem that a huge percentage of people who have taken Paxlovid have rebounded.
The silence of the CDC, FDA, NIH, and Dr. Fauci (who himself had a rebound case after taking Paxlovid) is deafening, but also predictable.
Similar to Vaccines and Boosters
In case this feels familiar, that’s because it is. Americans have seen the exact same thing before regarding Covid-19 vaccine adverse effects. While the federal government scolded Americans for not getting vaccines and boosters, they simultaneously remained silent on adverse events and even complacent in suppressing them.
Even if Paxlovid was effective, do patients need it? At this point, the same question goes for Covid-19 vaccines and boosters. The dominant variants today typically produce a milder infection; most people get minimal to moderate cold-like symptoms from Covid infections whether vaccinated or not.
It’s also telling that many Americans aren’t interested in boosters. If they had been shown to work, people would be taking them — but they haven’t, so people aren’t. In the U.S. alone, the government has been forced to throw out more than 82 million vaccine/booster doses, yet Americans aren’t dropping dead everywhere from Covid-19. Even leftist academic centers can’t hide objective epidemiological evidence coming out of hospitals in recent months that illustrate record lows in Covid-19-related hospital ICU admissions.
Digging Their Hole Deeper
Despite all of that, the White House is still endlessly seeking to purchase more vaccines. By July 29, the White House had committed to purchasing a total of 171 million Covid-19 vaccine doses for the new omicron mutations of Covid-19, despite lacking trial evidence of safety or efficacy — e.g., exactly like they did with Paxlovid!
The combination of promoting endless boosters of a vaccine that fails to prevent infection or transmission, along with promoting Pfizer’s Paxlovid despite its ineffectiveness and mysterious “rebound” pharmacology, makes me wonder about something that I have thought about for a long time, especially as a former senior FDA official: Is there some sort of unholy union between the FDA, Pfizer, and the Biden White House?
Pfizer spends millions in lobbying and campaign contributions. Its revolving doorwith government health agencies is concerning. Would the Biden White House dare place Americans’ public health at risk in the name of politics? I pray the answer is no and also hope that I am wrong, perhaps missing part of the story, but a compelling amount of information points to my suspicions being accurate.
The White House seems eager to funnel fortunes to Big Pharma for unproven, and possibly unsafe or unneeded, drugs. Americans should very carefully consider what they are hearing from the White House, its officials, and all federal alphabet agencies about the Paxlovid “wonder drug.”
Reprinted from The Federalist
Author
Dr. David Gortler, a 2023 Brownstone Fellow, is a pharmacologist, pharmacist, research scientist and a former member of the FDA Senior Executive Leadership Team who served as senior advisor to the FDA Commissioner on matters of: FDA regulatory affairs, drug safety and FDA science policy. He is a former Yale University and Georgetown University didactic professor of pharmacology and biotechnology, with over a decade of academic pedagogy and bench research, as part of his nearly two decades of experience in drug development. He also serves as a scholar at the Ethics and Public Policy Center
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