FDA Rushes to Grant EUAs to Two More COVID Drugs With No Long-Term Safety or Efficacy Data, While Ignoring a Mountain of Evidence Supporting HCQ, Ivermectin

Published February 10, 2022

PJ Media

Under President Biden, the FDA, which had for decades advocated for the use of inexpensive generic drugs whenever possible, is suddenly inaudible and has even spoken out against inexpensive, widely available generic drugs that likely ameliorate COVID symptoms, even though these drugs have decades of safety data behind them. There are two leading explanations for this otherwise inexplicable turn of events: politics and money.  

Let’s start with politics. Under Biden, the FDA has made it very clear for over two years that they do not approve of ivermectin and hydroxychloroquine for treatment of COVID-19, saying there is “insufficient data.” They went so far as to discredit one of these inexpensive treatments on their websites and on social media, implying it’s only for animal deworming (“You are not a horse. You are not a cow. Seriously, y’all. Stop it,” they said). 

By contrast, the FDA is silent as the grave when it comes to widespread off-label, long-term drug safety of puberty-blockers and cross-sex hormones being administered to 13-year-old kids that may render them permanently altered and infertile. I don’t expect FDA will tweet “You are not a girl, you are a boy. Seriously, y’all…” anytime soon.  

The difference is in narratives. Dangerous off-label usage of drugs is fine to further transgender ideology, but for COVID, it would contradict the narrative that the only way out of the pandemic is through forced, mass vaccination and repeated, titanically ineffective booster shots.  

With epidemiological findings in on vaccination and boosters verified from around the world, it only makes sense to consider other available treatment strategies.  

And as it turns out, there are readily available drugs that can be used to help lessen COVID symptoms that may prompt unvaccinated people to weigh the risks differently and decline a vaccine or booster shot. According to Anthony Fauci and Joe Biden, this is flatly unacceptable, because, they claim to know better than you and your family about your health and medical history. What if it turns out cheap generic drugs could have been enough for millions of healthy young people forced to mask and vaccinate for the last two years? That would cause Biden a huge political problem, so it’s better if the FDA—an agency with $3.6 billion in discretionary spending and over 18,000 employees—would not publicly confirm the mounting evidence that these generics help with COVID.

Because the FDA won’t share the latest efficacy information on ivermectin and hydroxychloroquine treatments, I will put them here. 

I love America with every iota of my body and soul, and can only hope and pray that I won’t be branded a terrorist threat to the U.S Homeland and/or otherwise fined, banned, and spoken harshly about for pointing out these objective, independent, scientific findings.  

Current Ivermectin Evidence: 77 studies involving 85,761 people showing a 64% [5771%] improvement

Current Hydroxychloroquine Evidence:  224 (of 307 total) positive studies involving 300,019 people.  

  • Thirty-three of the 35 early treatment studies report a positive effect for hydroxychloroquine (64% improvement Relative Risk 0.36 [0.29-0.46]).
  • Late treatment is less successful, with only 68% of the 207 studies reporting a positive effect. Late-stage treatment is ineffective with hydroxychloroquine and all other antiviral medications as well.  
  • Eighty percent of randomized controlled trials (RCTs) for early, pre-exposure prophylaxis treatment report positive effects. The probability of results as good or better for an ineffective treatment is 0.0059, (with p<0.05 being considered statistically significant).
  • Meta-analysis using the most serious outcome reported shows 64% [54-71%] improvement for hydroxychloroquine’s 35 early-treatment studies. Results are similar after exclusion-based sensitivity analysis and after restriction to peer-reviewed studies. Restricting to the nine randomized controlled trials shows 45% [14-64%] improvement, and restricting to the 14 mortality results shows 74% [61-83%] lower mortality.  
  • Curiously, there is noteworthy evidence of bias toward publishing negative results in North America. Worldwide, 80.7% of hydroxychloroquine studies show positive outcomes compared to only 46.6% of studies in North America. Consequently, studies from North America are 2.8 times more likely to report negative results than studies from the rest of the world combined, p = 0.0000000153, (with p<0.05 being considered statistically significant).  

It is no longer surprising that these data haven’t been publicized by the FDA, because under Biden and HHS Secretary Xavier Becerra, the FDA no longer functions as an independent, science-based public health organization. Like so many other federal health agencies, the FDA executives and staff have chosen to follow the bidding of the White House instead of following objective scientific evidence.  

Besides politics, a big explanation for the lack of scientific curiosity could be money. There are billions of dollars being made on COVID vaccines and endless boosters. By contrast, there is little profit to be had from inexpensive, off-patent, easily available generic drugs. This means two things. First, the pharmaceutical companies have a strong financial motive to attempt to discredit the low-cost competition, and second, because the FDA and NIH aren’t funding widespread research on these generic drugs, it is much harder for studies to be done on an emergency basis because, again, there is no money at the end of it.  

Should Americans believe what the federal government keeps repeating, or should they believe their own eyes?  

Any person can see that the FDA’s willful disinterest in anything hydroxychloroquine- and Ivermectin-related is unscientific. In addition to the abundance of proof of their effectiveness, these drugs have a combined nine decades’ worth of safety data, yet are still somehow perceived to be inferior to Merck’s molnupiravir (Lagevrio) and Pfizer’s nirmatrelvir/ritonavir (Paxlovid).  Both of these drugs were quietly given an EUA in late December of 2021, as Americans were busily preparing for Christmas and the new year, while data on ivermectin and hydroxychloroquine are at best completely ignored and at worst excoriated by Biden’s FDA.  

Lower cost and long-term safety notwithstanding, in contradiction to the decades and hundreds of thousands of participants treated with ivermectin or hydroxychloroquine, molnupiravir was granted an EUA based on a single Merck-run study involving a mere 716 participants receiving treatment. Pfizer’s Paxlovid approval was based on a single Pfizer-run study involving a mere 607 participants receiving treatment. The FDA and the White House are promoting and funding two drugs that have been on the market for about one month, based on about one month’s worth of safety data, versus two other drugs that have decades worth of safety data behind them, tested in a diverse, worldwide population.   

Despite that, the Biden administration has committed $5 billion of taxpayer funding for Pfizer’s Paxlovid and $2.2 billion for Merck’s molnupiravir, making them both instantaneous “blockbuster” drugs, since the criteria for a “blockbuster” drug is $1 billion in sales per year.  

We’ve all heard those “two people” adages before, and here’s another to ponder: There are two kinds of people in this world: people who think the government knows best … and people who think.  

Can President Biden survive politically if this turns out to be (another) gigantic misallocation of resources? Although Biden desperately wants to avoid that question, scientists need to stop running cover for him and admit the truth: the Biden White House narrative on COVID treatments is disintegrating.  

Dr. David Gortler is a pharmacologist, pharmacist, and an FDA and health policy fellow at the Ethics and Public Policy Center. He was a professor of pharmacology and biotechnology at the Yale University School of Medicine, where he also served at Yale’s Bioethicist Center, and was an FDA medical officer who was later appointed by the White House as senior advisor to the FDA commissioner for drug safety, FDA science policy, and FDA regulatory affairs. He is a columnist at Forbes, where he writes on drug safety, health care, and FDA policy.

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